Coronary Heart #27

NICE APPRAISAL ONDRONEDARONE

RAIGMORE HOSPITALSITE VISIT

CARDIOLOGY DEPARTMENTMANAGEMENTThree Top Tips

ECG CHALLENGE

FUTURE TECHNOLOGY NEWS

LATEST PRODUCT NEWSFeaturing 14 Companies

LEFT ATRIAL APPENDAGEOCCLUSION:A Review

TAVI’sA Cardiac Surgeon’s Point of View

CARDIAC CATH • EP • CRM • ECHO • CT/MRI

Issue 27 • Nov/Dec 2010Subscribe FREE OnlineCardiologyHD.com

www.cardiologyhd.com Nov/Dec 2010 3

Disclaimer:Coronary Heart should never be regarded as an authoritati ve peer reviewed medical journal. Coronary Heart has been designed as a guide only, to inform readers who work in the cardiology environment about latest news stories and the diff erent techniques used by others around the world. Whilst all care is taken in reviewing arti cles obtained from various companies and contributors, it is not possible to confi rm the accuracy of all statements. Therefore it is the reader’s responsibility that any advice provided in this publi-cati on should be carefully checked themselves, by either contacti ng the companies involved or speaking to those with skills in the specifi c area. Readers should always re check claims made in this publicati on before employing them in their own work environment. Opinions expressed by contributors are their own and not necessarily those of their insti tuti on, Coronary Heart Publishing Ltd or the editorial staff .

Copyright © 2006 -2010 by Coronary Heart Publishing Ltd. All rights reserved. Material may only be reproduced by prior arrangement and with due acknowledgment of Coronary Heart Publishing. The publicati on of an adverti sement or product review does not imply that a product is recommended by Coronary Heart Publishing Ltd.


Latest Product NewsAbbott ’s Groundbreaking Bioresorbable Vascular Scaff old Implanted in First UK Pati entAbbott enrolled its fi rst UK heart pati ent at the University Hospi-tals of Leicester as part of an internati onal trial to evaluate the per-formance of the company’s revoluti onary bioresorbable vascular scaff old (BVS) - the fi rst drug-eluti ng device of its kind designed to open up a blocked artery without leaving behind a permanent met-al implant in the blood vessel. This potenti al restorati on of vessel functi on makes Abbott ’s BVS unique in the treatment of coronary artery disease.

The ABSORB EXTEND trial, which will enrol pati ents from 100 centres worldwide, reinforces Abbott ’s commitment to research and devel-op innovati ve devices for vascular care. “The BVS promises to be an important next step in the treatment of coronary artery disease, and Abbott is committ ed to making this revoluti onary technology a clini-cal reality,” said Sue Hudson, General Manager, Abbott Vascular, UK & Ireland.

CYPHER Stent 10 Year Follow-upCordis Corporati on announced at the European Society of Cardiology in Stockholm on August 31st that the results of follow-up tests under-taken ten years aft er the fi rst pati ent was treated with a CYPHER® Sirolimus-eluti ng coronary stent have proven outstanding long-term effi cacy and safety.

The fi rst pati ent was treated in 1999 with the CYPHER® stent at the age of 75 aft er her coronary angiography showed a signifi cant, single, de novo lesion in the proximal left anterior descending (LAD) artery and under-went further invasive follow-up revealing a sustained anti -proliferati ve eff ect of the CYPHER® stent by both angiography and IVUS examinati on in 2009. The pati ent also underwent an opti cal coherence tomography (OCT) assessment which revealed a complete coverage of over 90% of the analysed struts. The follow-up proce-dure was broadcast live during the 2009 meeti ng of the Lati n America Society of Interventi onal Cardiology (SOLACI, Rio de Janeiro - Brazil).

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Abbott ’s New Bioresorbable Vascular Scaff old

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Balloon-like Handling with the New Resolute Integrity StentIn early September 2010, cardiologists from Southampton General Hospital were the fi rst in Europe to implant Medtron-ic’s new Resolute Integrity Stent System, the latest drug-elut-ing stent to hit the market in Europe. The Resolute features a new advanced design, based on conti nuous sinusoid tech-nology, allowing it to be more fl exible than other stents. This improves deliverability to navigate through tortuous arteries easily, and once in place mould more successfully to the ves-sel walls.

Dr Iain Simpson, the Consultant cardiologist who performed the fi rst procedure stated “The new stent is more fl exible for getti ng around twisty arteries, giving us another opti on when treati ng pati ents with coronary heart disease or those who have suff ered a heart att ack”.

Recently other cardiologists in Europe have given the stent rave reviews. Dr Hamm in Germany stated, “The Resolute Integrity is the fi rst stent that feels like a balloon.” Whilst Dr Brunner in

Austria stated, “This is simply the best stent on the market.”

For more informati on contact your Medtronic representati ve

2� Sep/Oct 2010 www.cardiologyhd.com

October 3-6Heart Rhythm Congress 2010Hilton Birmingham MetropoleBirmingham, Englandwww.heartrhythmcongress.com

October29-30

Briti sh Society of Echocardiography Annual Meeti ng & Exhibiti onBournemouth, Englandwww.bsecho.org

November 2Chronic Total Occlusions 7Clinical Educati on Centre, Glenfi eld HospitalLeicester, Englandwww.millbrookconferences.co.uk

November 18-19

Bristol PCI Course 2010The Educati on Centre, Bristol Royal Infi rmaryBristol, Englandwww.millbrookconferences.co.uk

November 22-23

Europe AF 2010London Hilton Metropole Hotel London, Englandwww.europeaf.com

November 25

BLT Course 2010 : Bifurcati on lesion treatmentNati onal Motorcycle MuseumSolihull, Englandwww.millbrookconferences.co.uk

January 26 - 28, 2010

ACI 2011 : Advanced Cardiovascular Interventi on 2011London Hilton Metropole HotelLondon, Englandwww.millbrookconferences.co.uk

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LIKE TO BEFEATURED?

For further details on how your event can be featured here contact us at:

[email protected]

For a list of conferences and events around the globe visit our website:www.cardiologyhd.com

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Events


Questi on on Page: 18

1. This 12-lead ECG shows characteristi cs of Brugada syndrome. Lead V1 and V2 demonstrate an ‘rSr1’ patt ern with a coved ele-vati on of the ST segment in these leads. This qualifi es as a type 1 Brugada ECG.

2. Since its introducti on as a clinical enti ty in 1992, the Brugada syndrome has progressed from being a rare disease to one that is second only to road traffi c accidents as a cause of death among young adults in some countries. The syndrome is asso-ciated with a high risk for sudden cardiac death in young and otherwise healthy adults, and less frequently in infants and chil-dren. The syndrome is esti mated to be responsible for at least 4% of all sudden deaths and at least 20% of sudden deaths in pati ents with structurally normal hearts. Brugada syndrome is defi niti vely diagnosed when a type 1 coved ST-segment eleva-ti on is observed in at least one right precordial lead (V1 to V3) in the presence or absence of a sodium channel– blocking agent, and in conjuncti on with one of the following: documented ven-tricular fi brillati on (VF), polymorphic ventricular tachycardia (VT), a family history of sudden cardiac death at <45 years old, coved-type ECGs in family members, inducibility of VT with pro-grammed electrical sti mulati on, syncope, or nocturnal agonal respirati on.

3. Inheritance of Brugada syndrome occurs via an autosomal dominant mode of transmission. The fi rst and only gene to be linked to Brugada syndrome is SCN5A, the gene that encodes for the α subunit of the cardiac sodium channel gene.

More than 80 mutati ons in SCN5A have been linked to the syndrome and about 2 dozen of these mutati ons have shown to result in loss of functi on because of failure of the sodium channel to express; this can be seen as a shift in the voltage and ti me dependence of sodium channel current acti vati on, inacti vati on, or reacti vati on; entry of the sodium channel into an intermediate state of inacti vati on from which it recovers more slowly; or accelerated inacti vati on of the sodium channel.

A second locus on chromosome 3, close to but apart from the SCN5A locus, was linked recently to Brugada syndrome in a large pedigree in which the syndrome is autosomal dominant inher-ited and associated with progressive conducti on disease, a low sensiti vity to procainamide, and a relati vely benign prognosis.

SCN5A mutati ons account for about 18% to 30% of Brugada syn-drome cases. A higher incidence of SCN5A mutati ons has been reported in familial than in sporadic cases. Of note, negati ve SCN5A results do not rule out causal gene mutati ons because, in general, the promoter region, crypti c splicing mutati ons, or the presence of gross rearrangements is not investi gated.

Full arti cle referenced from: C Antzelevitch, P Brugada et al. Brugada Syndrome. Report of the Second Consensus. Endorsed by the Heart Rhythm Society and the European Heart Rhythm Associati on. Circulati on. 2005; 111: 659-670.

Ms Sophie BlackmanCoronary Heart Management and CRM Consulti ng Editor

Head of Clinical Cardiac PhysiologyWest Hertf ordshire NHS Trust United Kingdom

AnswerSophie Blackman’s ECG Challenge

Mr Tim LarnerDirector / FounderLatest Technology & All-Round Computer Geek

Future Technology News >>>The Fraunhofer Insti tute in Germany is working on a new system to measure cardiac pressure “on-demand, anywhere”. Batt ery-free miniature sensors are implanted into the heart wall with the aid of a catheter and can give physicians up to 200 measurements per second post procedure.

Source: Fraunhofer-Gesellschaft

Tech companies IMEC & the Holst Center have designed an applicati on for Android phones allowing you to monitor your heart rate. With sensors att ached to the body via a necklace, the data can be wirelessly transmitt ed to the phone and within seconds provide a detailed ECG and heart rate monitoring report. This can then be

stored or emailed to your GP.

Source: IMEC

6 Nov/Dec 2010 www.cardiologyhd.com

Data from Multi ple Clinical Trials of OrbusNeich’s Genous™ Bio-engineered R Stent™ Demonstrate Safety and Eff ecti veness Across Challenging Pati ent Subsets as Presented at TCT 2010 in WashingtonThe results presented include:

• Subset analyses of the global e-HEALING registry show that the Genous Bio-engineered R stent is safe and eff ecti ve in diabeti c pati ents, elderly pati ents over the age of 80 and in pati ents who stopped dual anti platelet therapy (DAPT) at 30 days.

• Twelve-month follow-up results from the JACK-EPC clinical trial, an investi gator-initi ated, randomized trial that compared the Genous Bio-engineered R stent with bare metal stents (BMS) in pati ents with acute coronary syndromes, showed the major adverse cardiac event (MACE) rate in Genous Bio-engineered R stent treated pati ents was 13.3 percent compared to 23.3 per-cent in BMS pati ents.

• Thirty-day follow-up opti cal coherence tomography (OCT) evalu-ati ons from 13 pati ents treated with the Genous Bio-engineered Cobalt Chromium Stent showed complete endothelializati on in majority of pati ents at 30 days post-implantati on.

For more informati on, visit www.OrbusNeich.com.

LEADERS Three-Year Results Suggest Improved Safety and Effi cacy of BioMatrix Flex™ over Cypher® Select™Three-year results from the LEADERS trial, showing a conti nuing pos-iti ve trend towards a safety and effi cacy benefi t for BioMatrix Flex™ compared to Cypher® Select™, were presented at TCT 2010.

In the all-comers study populati on there were similar outcomes for BioMatrix Flex, Biosensors’ Biolimus A9™-eluti ng stent system with abluminal biodegradable polymer, and Cypher Select, Johnson & Johnson’s sirolimus-eluti ng stent system with a durable polymer, in respect of MACE (major adverse cardiac events) at three years. There was a diverging trend towards a lower rate of MACE in pati ents treat-ed with BioMatrix Flex versus those treated with Cypher Select when compared to both one and two year results.

Occurrence of very late stent thrombosis (VLST) events was low: a cumulati ve 0.2% for BioMatrix Flex out to three years, compared with 0.9% for Cypher Select observed within the same period.

Image courtesy Biosensors

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Nine-month results from PLATINUM clinical program presented at TCTBoston Scienti fi c Corporati on announced data from its PLATINUM QCA study, which is designed to evaluate the PROMUS Element™ Everolimus-Eluti ng Plati num Chromium Coronary Stent. The results provided nine-month QCA and IVUS data supporti ng the safety and effi cacy of the PROMUS Element Stent.

Analysis of the data was presented by Ian Meredith, at TCT in Washington, D.C who stated, “The nine-month angio-graphic and IVUS data from the PLATINUM QCA study are impressive and show the acute performance advantages of the plati num chromium PROMUS Element Stent. With the same drug and polymer loading and comparable release kineti cs as the PROMUS® Stent, the PROMUS Element Stent achieved similar late loss (0.17 mm ± 0.25 mm) and signifi -cantly bett er stent appositi on. These results give me great confi dence in the transfer-ability of the everolimus drug and its proven clinical outcomes, as well as the potenti al benefi ts of the new plati num chromium alloy.”

Contact your local Boston Scienti fi c representa-ti ve for more details.

This Stent Featured in Edition 225

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TAVI’sMr Vinayak BabatConsultant in Cardiac SurgeryGuys and St Thomas’ Hospital, London, UK

Cardiac Surgeon Interview

When do you think the age criteria will shift so that younger pati ents, who may wish for fem-oral TAVI rather than surgical AVR, can be treated? What about the congenital group?

I think it will take at least 5-10 years before we start using it for younger pati ents. And the rea-son for that is very sim-ple. In younger pati ents’ surgical AVR at present is the gold standard. It is predictable and in younger pati ents the risk is 1-3%. TAVI at present is

only being used in surgically high-risk groups and even here there are compromises. There are issues of positi oning in around 5% of pati ents or 2% in experienced hands. The idea of TAVI’s is to reduce the risk to the pati ents, and unti l we can reduce positi oning risks from 3% to 0% I think we should wait.

The second questi on in relati on to the congenital group is very inter-esti ng. There are two types of congenital pati ents. Firstly and the most common is those with a bicuspid valve, at present you can-not deploy a TAVI without inferior results in this group due to the increased risk of paravalvular leak and coronary occlusion and it is a contra-indicati on.

But there is another congenital group who have got trileafl et stenosis and I think TAVI might be a bett er opti on here. Kids always grow out of the valve size, so if surgery can be delayed I think there may be an interim applicati on for TAVI in this group.

What is the smallest size femoral sheath that you see being capable of accommodati ng TAVI?

As a surgeon I fi nd this questi on very threatening (laughing), but to be very honest, the Edwards valve used at present is made of bovine pericardium, which is thick, durable and lasts 15-20 years. The thick-ness however takes away the compressibility of the valve and I think the sheath size may get down to 16FR but not more than that.

There is a chance that there will be 2 types of products available in the future, so that you have a valve that is made of porcine valve material or an arti fi cial material like polyurethane; which are thinner but not as durable. But if you know the life expectancy of a parti cu-lar pati ent is less than 10 years, then you could use a thinner valve; that could then be deployed through a smaller sheath. In younger pati ents you would want to use a larger sheath for a more durable valve.

Do you see the costs coming down so that funding by commissioners stops being a problem?

I think that is a very good questi on, because we have now seen the benefi ts in the clinical setti ng, we can look at costs two ways. A tra-diti onal operati on on a sick pati ent incurs greater in-hospital costs which may then exceed the costs of a TAVI. At the same ti me, more competi ti on will drive down prices.

If treat them either medically or surgically we must look at the total expenditure on the pati ent and include all hospital episodes all hos-pital costs. As cost eff ecti veness data becomes available the business case for TAVI will become much stronger.

Also commissioners need to hear the feedback from community to realize how clinical outcomes, length of stay etc are all improved.

Should all labs undertaking TAVI have (and conti nue to have) vascular surgery on site and available at short noti ce?

In the UK virtually all cardiac surgeons are trained in peripheral vas-cular up to a point, and that’s why the multi -disciplinary approach, which Edwards promotes, has benefi ts. So if you have vascular access problems, there is a surgeon available who has had some vascular training. Having vascular surgeons onsite is an additi onal benefi t but I don’t think it is mandatory in all pati ents to have that back-up all the ti me. If we have any doubts in regards to access problems we discuss it with vascular radiologists and surgeons.

If we think the access site is not suitable for trans-femoral, the beau-ty of the Edwards device is that you can use it trans-apically in the same pati ent. So we don’t push ourselves to limits and take risks that are unnecessary. If your case selecti on is good you will end up with fewer problems.

Interviewed at Edwards Lifesciences’ European Headquarters in Nyon, Switzerland, by Tim Larner, Director of Coronary Heart Publishing Ltd.

Questi ons by Dr Bernard Clarke, Consultant Cardiologist, Manchester Heart Centre

Photography: Tim LarnerValve Image: Courtesy Edwards Lifesciences


LAAOLeft Atrial Appendage Occlusion : A Review

Dr Tim Gatt ornaCardiology fellowRoyal Perth HospitalAustralia

Atrial fi brillati on (AF) is the commonest cardiac arrhythmia with a prevalence of 0.9% in the general populati on, increasing to >13% of people over the age of 80.¹ As our populati on ages,

the prevalence of AF will conti nue to rise with signifi cant clinical and economic implicati ons.2 The most feared and catastrophic complica-ti on of AF is stroke, which is increased fi vefold over an age-matched populati on in sinus rhythm. This is independent of other factors and mostly secondary to thromboembolic events.3

Proven therapies to reduce AF-associated stroke include oral anti co-agulati on with vitamin K antagonists, such as warfarin. However, its narrow therapeuti c window and large number of drug, dietary, and metabolic interacti ons make pati ent response unpredictable and dif-fi cult to manage. This is parti cularly true in older pati ents who are at increased bleeding and stroke risk. Newer pharmacological agents such as the direct thrombin inhibitor, dabigatran, are promising and show similar stroke protecti on to warfarin with less signifi cant bleed-ing.4 Several ongoing studies are examining the potenti al role of new orally acti ve anti -factor X agents.

Given the problems with available pharmacological therapies there has been an impetus for the development of a device-based soluti on for AF-associated stroke. Such strategies have focussed on occlusion of the left atrial appendage (LAA). The reason is that this site is pre-disposed to in-situ thrombus formati on and accounts for the origin of 90% of atrial thrombi in pati ents with non-valvular atrial fi brilla-ti on (NVAF). 5-7The LAA, an embryonic remnant of the original LA, is a multi -lobed, trabeculated structure with considerable anatomical variati on att ached to the LA cavity. In pati ents with AF it has been found to be larger and with greater dysfuncti on, which are mark-ers for increased embolic risk.6, 8-10 Also, previous observati ons have demonstrated that most embolic phenomena were associated with LAA thrombus in pati ents with AF.11,12

Interest in LAA removal or occlusion dates back to the 1930s and can be safely performed during cardiac surgery either with sutures or staples.13 This is most oft en performed during valve surgery or during Maze procedures (the creati on of left atrial lesion patt erns during open heart surgery to eliminate AF), although isolated LAA exclusion via a thoracoscopic approach has been shown to be feasi-ble and safe.14

An alternati ve, less invasive means of LAA exclusion using endo-vascular techniques has been developed. Three diff erent devices

have been used to date: percutaneous LAA transcatheter occlusion (PLAATO) system, the WATCHMAN system and the Amplatzer car-diac plug. These devices are delivered to the LAA following a per-cutaneous femoral transvenous approach and transeptal puncture under fl uoroscopic and transoesophageal echocardiographic (TOE) guidance.

The fi rst of these was the PLAATO system (ev3, Inc., Plymouth, Min-nesota) (Figure 1) consisti ng of a self-expanding niti nol implant cov-ered with an occlusive ePTFE (expanded polytetrafl uoroethylene) membrane.15 Despite initi ally encouraging results in pati ents who had contraindicati ons to warfarin device development was halted for fi nancial considerati ons in December 2006.16,17

The second percutaneous LAA exclusion device is the Watchman Left Atrial Appendage System (Atritech Inc., Plymouth, Minnesota) (Fig-ure 2). The device is a self-expanding niti nol frame structure with fi xati on barbs and a permeable polyester fabric that covers the atrial side.18

The pivotal clinical trial evaluati ng this device was the Embolic Pro-tecti on in Pati ents with Atrial Fibrillati on (PROTECT-AF) trial.19 This was a multi centre, prospecti ve, non-inferiority, unblinded study of pati ents with NVAF who were deemed eligible for warfarin therapy. Pati ents were enrolled in the trial if they had a CHADS2 risk score of 1 or more (ie, at least one of the following: previous stroke or tran-sient ischaemic att ack, congesti ve cardiac failure, diabetes mellitus,

Figure 1: The PLAATO device


Journals

Heart FailureSHIFT was a randomised comparison of Ivabradine vs. placebo in sys-tolic heart failure pati ents in sinus rhythm, salami sliced into two par-allel arti cles. It att empts to answer the following questi ons: 1. What is the adverse prognosti c impact of elevated heart rate in systolic heart failure pati ents? Answer: 16% increased risk of HF events for every fi ve bpm increase in heart rate; 2. Is the elevated heart rate causal or just a marker of other processes? Answer: Yes, increased baseline heart rate is neutralised by treatment; 3. Is heart rate itself a justi -fi able pharmacological target? Answer: Yes, elevated rates and the benefi t of lowering them remain prevalent, despite prior pharma-cological therapy; 4. Is Ivabradine an eff ecti ve agent in this regard? Answer: Yes, a 5% absolute reducti on of events from 29 to 25% in the ivabradine group at the cost of 4% excess symptomati c bradycardias and 2% visual disturbances. An accompanying editorial welcomes the clarity of data on the impact of heart rate, but expresses cauti on that there may have been inadequate doses of beta blockers in the individuals responding to ivabradine.

Swedberg and others. The Lancet, 2010; 376:9744, 875 – 885.

Böhm and others. The Lancet, 2010; 376:9744, 886 – 894.

Teerlink. The Lancet, 2010; 376:9744, 847 – 84.

It is good, though rare, to see a negati ve trial published in a decent journal. Rolofylline, an adenosine A1-receptor antagonist was test-ed against placebo in 2033 pati ents with acute heart failure and impaired renal functi on. It made no diff erence than placebo to the primary endpoint (treatment success, treatment failure, or no change in the pati ent’s clinical conditi on). Well done to the authors and to the New England Journal of Medicine for publishing it.

Massie and others. NEJM; 2010; 363:1419-28.

Putti ng Lead in Yorkshire PencilsAnother potenti al treatment for use in heart failure and cardiac dis-ease is testosterone. A longitudinal study from a group in Sheffi eld and Barnsley has demonstrated that pati ents with vascular disease and testosterone defi ciency, who were followed up for almost 7 years, had an increased risk of mortality (21%) relati ve to those with normal testosterone levels (12%, p=0.002). Having low testoster-one levels is common - up to 24% depending on the test used in the populati on studied. The obvious next step is a randomised controlled trial of testosterone replacement therapy in high risk pati ents with testosterone defi ciency.

Malkin and others. Heart 2010; 96:1821e1825.

Toys for GeeksCircumferenti al pulmonary vein ablati on has always been an att rac-ti ve target for custom designed catheters. In the last few years we have had at least one catheter available which seems to be safe and eff ecti ve (PVAC), although concerns have been that it ablates further onto the venous side of the atrium than ideally placed point by point lesions. We now have the fi rst of a series of randomised comparisons; 102 pati ents with paroxysmal atrial fi brillati on were randomised to either mapping, guided point by point, or PVAC pulmonary vein isola-ti on. Procedure and screening ti mes were signifi cantly shorter in the PVAC group, whilst fi rst procedure success rates were comparable in the PVAC and conventi onal arms (77 vs. 71% over a short follow up of 6 months). The PVAC was noted to be unsuited to single common left sided atria.

Alan Bulava and others. PACE 2010; 33:1039–1046.

Ablati on of typical atrial fl utt er is now regarded as standard fi rst line therapy and highly successful. In an att empt to improve on this already highly effi cient procedure, a multi electrode catheter (TVAC) from the same stable as the PVAC was used to ablate the cavotri-cuspid isthmus in a randomised comparison with 8mm ti p catheter ablati on. Thirty pati ents in each group underwent ablati on with sig-nifi cantly shorter radio frequency (8.5 vs. 14.7 min) and procedure ti mes (40.2 vs. 60.5 min) in the TVAC group. There was one failure to achieve block in the TVAC group and two late recurrences in each group.

Ali Erdogan and others. J Cardiovasc Electrophysiol. 2010; 21:1109-1113.

Resuscitati onIt used to be said it was impossible to conduct meaningful compari-sons of resuscitati on techniques, due the ethical diffi culti es involved. This has now been thoroughly disproved by the number of studies recently published on the subject and with yet another compari-son of chest compression only vs. classically taught CPR, it is almost becoming boring.

In a comparison of classical CPR vs. chest compressions only vs. no CPR, provided by non-medical bystanders in over 5000 pati ents, sur-vival to hospital discharge was signifi cantly improved by chest com-pressions only (13.3%) when compared to both classical CPR (7.8%) and no CPR (5.2%). In fact, aft er appropriate adjustment, classical CPR may off er no survival benefi t against no CPR.

Dr John PaiseyJournal ReviewerConsultant Cardiologist, Royal Bournemouth and Christchurch Hospitals NHS Foundati on Trust

Dr Dan McKenzieJournal ReviewerConsultant Cardiologist, Musgrove Park Hospital, Taunton and Somerset NHS Foundati on Trust


PharmaCardiology

Atrial Fibrillati on (AF) is characterised by uncoordinated atrial acti vity with consequent deteriorati on of atrial mechanical functi on. AF is the most common arrhythmia and responsible

for many hospital admissions. This is due to the aging populati on and an increase in heart disease. There are three main objecti ves for the management of pati ents with AF: rate control, preventi on of thromboembolism, and correcti on of the rhythm disturbance.

Dronedarone marketed as Multaq by Sanofi -Aventi s is licensed for clinically stable adult pati ents with a history of, or current non-per-manent atrial fi brillati on (AF) to prevent recurrence of AF or to lower ventricular rate. Dronedarone belongs to the benzofuran class of anti arrhythmic drugs and is contraindicated in unstable pati ents with NYHA class III and IV heart failure. Its use is also not recommended in stable pati ents with NYHA class III heart failure or with left ven-tricular ejecti on fracti on less than 35%.

NICE Guidance using the single technology appraisal process was published in August 2010 (www.nice.org.uk/TA197) and this paper aims to give a summary of the main points.

NICE Clinical Guideline 36 in 2006 (management of AF) states that Beta blockers in additi on to anti coagulati on should be the initi al treatment opti on for people with symptomati c paroxysmal atrial fi brillati on and people with persistent atrial fi brillati on in whom an anti arrhythmic drug is needed to maintain sinus rhythm aft er cardio-version. Amiodarone, sotalol or a class 1c drug should be used as a second line treatment opti on if standard beta blockers are contrain-dicated or fail to improve symptoms.

Amiodarone was noted to be an eff ecti ve anti arrhythmic drug for controlling AF but due to high level of toxicity many people were not able to tolerate it. There were also many pati ents who could not tolerate a 1c anti arrhythmic agent or sotalol who may benefi t from

dronedarone instead with a more favourable side eff ect profi le in some pati ents. The guide recommends initi ati on of dronedarone under the supervision of a specialist in secondary care setti ng.

Clinical informati on on dosage & administrati on

Treatment with dronedarone is initi ated at 400mg twice a day in adults with a morning and evening meal. If the pati ent is already

NICE Appraisal on Dronedarone for the treatment of non-permanent Atrial Fibrillati on (AF)

Dr Mojgan Sani, DPharm, MBA, MRPharmS

Head of Clinical Pharmacy, Royal Berkshire Foundati on Trust & Nati onal non-medical prescribing Facilitator, Nati onal Prescribing Centre.

Dronedarone is recommended in pati ents with non-permanent AF only in people:

◊ Whose AF is not controlled by fi rst-line therapy (usually including beta blockers), that is, as a second line opti on,

and

◊ Who have at least one of the following cardiovascular risk factors:

› hypertension requiring drugs of at least two diff erent classes

› diabetes mellitus › previous transient ischaemic att ack, stroke or systemic embolism

› left atrial diameter of 50mm or greater › left ventricular ejecti on fracti on less than 40% or › age 70 years or older,

and

◊ Who do not have unstable NYHA class III or IV heart failure.

NICE Guidance recommendation for use of Dronedarone


Clinical Background

This ECG was recorded in at 10mm/mV and 25mm/sec.

Questi ons1. What underlying channelopathy is evident on this

ECG?

2. Explain the arrhythmic issues associated with this syndrome.

3. What is the inherited geneti c mutati on associated with this disorder?

Answer on Page: 27



ChallengeSophie Blackman’s ECG

Love our ECG Challenges?

We have 18 ECG Challenges on our website just waiti ng for you to solve, all of which have been featured in this publicati on over the years.

By popular demand, starti ng in 2011 we will be adding a bonus ECG Challenge online only, for those unable to wait a couple of months between editi ons. Lucky you!!

CardiologyHD.com


Management: Three Top TipsMs Sophie BlackmanCoronary Heart Management and CRM Consulti ng Editor

Head of Clinical Cardiac PhysiologyWest Hertf ordshire NHS Trust

The last few management arti cles I have writt en were directed at managers. This week I have my top 3 ti ps for the non-managerial staff members out there. These ti ps should give you insight that can help your manager out and in turn result in a positi ve working experience for you.

Remember this: A manager knows who turns up late, and who is lazy, who works hard to escape their emoti onal distress, who is a moti vator, who is working hard and who isn’t. I once worked with someone who would tell me every day every-thing they had done at work. I used to sit there thinking – yes that is your job, why are you telling me this? Don’t boast to your manager about your workload unless you have gone above and beyond your job descripti on.

If you are the one who goes to the manager to complain about other staff members work and to let your manager know how very hard you work comparati vely, then you are the one your manager is keep-ing an eye on. The ti me you spend looking at and complaining about what everyone else is doing (or not doing) is ti me you are not getti ng on with your own work – why adverti se the fact?

Soluti on: Help your manager by encouraging those around you in a way that moti vates them. Be the moti vator in your team and your manager will know it. They will thank you for helping rather than having to endure you complaining every day which they don’t have ti me for.

Remember this: A manager will be grateful if you bring them soluti ons not problems.

It is easy when a problem emerges to take it straight to your man-ager. ‘I can’t be expected to do this….’ ‘There isn’t enough ti me….’ ‘No I can’t’. These common statements we hear from staff do not help nor impress.

Soluti on: Tell your manager what changes can be made so the prob-lem doesn’t keep occurring. ‘I’ve noti ced X keeps happening, and I thought it would be a good soluti on if we perhaps did XYZ to make things easier…’ This is one part of the service the manager will now not need to review, it shows you have initi ati ve and some managerial qualiti es and this impresses your manager and also improves your working environment by getti ng rid of the problems.

Remember this: You don’t need to understand your manager’s role completely, but no matt er how good or bad you perceive your manager to be, rest assured they are busier, more stressed and hold more responsibility than you realise. Most managers, even if you do see outward signs of pressure upon them, keep the majority of their stresses and responsibiliti es from you.

Every piece of work that a member of your department does ulti -mately rests in the hands of your manager. They have to be the one accountable for errors, mistakes, complaints. Everything that you do as a worker directly aff ects your manager. It either makes their day easier or harder – and this is the very simple piece of informati on you must remember in order to learn how to get what you want from your manager.

Soluti on: In the simplest of terms, if you use your ti me to ensure that your managers’ workload is not increased by the somewhat simple yet ti me consuming complicati ons of the working day – then you can help your manager to achieve their targets. Work hard, work accurately and work well. Help those around you and be encouraging of good practi ce.

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A manager in a busy cardiac department has a job that is varied and unpredictable. There is always something that they have to be concentrati ng on, a pressure from above, or a target they have to achieve. If you can work in a way that supports your manager with some of the more simple tasks then you help them to focus on the part of their job that is more concentrated on your team and the work you do, allowing them to be a bett er manager to you. As a man-ager my favourite words to hear are ‘Is there anything I can help you out with?’ I am sure your manager will not mind hearing it once in a while either.

AssistanceManagement

Give your manager time to do their work

Provide solutions

Remember this:

A manager knows1

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ProtecX Medical Ltd launches new website.ProtecX is pleased to announce the launch of its new website due to go live at the end of November 2010.

We are proud to introduce this exciti ng development which as well as allowing customers to view our full range of radiati on protecti on and related products, also incorporates a tool to allow customers to request quotati ons on one or many of the products in our range.

This process has been designed to keep the customer informed of the progress of both the quotati on and subsequent order, through manufacture and delivery status. Customers will be able to uti lise a secure log in to the site to revisit quotes and view their history. The launch of our new website conti nues our aim of service improvement; we hope customers enjoy using this facility.

Our website can be found at: www.protecx.co.uk

PERFECTEMP™: An Innovati on In Operati ng Table Pati ent WarmingDot Medical Ltd is delighted to introduce the LMA PerfecT-emp™ under pati ent warming matt ress.

Maintaining normothermia in pati ents undergoing opera-ti ons can be a challenge. However the LMA PerfecTemp ™ is a new innovati on off ering warmth beneath the pati ent and advanced pressure reducti on to combat hypothermia and pressure sores.

The LMA PerfecTemp™ pati ent matt ress is

• Lightweight

• Durable

• Quiet

• Delivers controlled and consistent warming

• Has fi bre opti c sensors to measure temperature between the surface of the skin and the pad.

• Easy to clean

• Radio translucent

• Ideal for all operati ons, dialysis units and areas where pati ent warming is imperati ve

For further informati on, contact Dot Medical Ltd: Email: [email protected]: 01625 668811 or Fax: 01625 668855

Siemens introduces new soluti ons at European Cardiology Congress Siemens Healthcare presented its cardiology soluti ons at the Euro-pean Society of Cardiology (ESC) Congress 2010. The innovati ons showcased were designed to provide a higher quality of pati ent care and contribute to reducing costs.

The new 1.5 release of the ACUSON SC2000™ volume imaging ultra-sound system was on show at the Congress, it features a number of innovati ve workfl ow soluti ons and off ers a complete 2D and volu-metric system to improve effi ciency in routi ne echocardiography examinati ons. The recently launched MAGNETOM® Aera 1.5T and Skyra 3T systems were also presented for their ability to reduce the complexity of cardiac MR examinati ons and provide greater image consistency.

The Congress also dedicated special emphasis on the planning of Transcatheter Aorti c Valve Implantati on (TAVI) procedures with the SOMATOM Defi niti on Flash CT and imaging soft ware syngo.via.

Siemens held a number of satellite symposia on the latest cardiology treatments at the ECS Congress that can be viewed at www.siemens.com/esc

Above: New Syngo Aortic ValveGuide imaging software from Siemens Healthcare simplifies workflow for minimally

invasive heart valve implantation.

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New Millar Mikro-Cath™ Disposable Pressure Catheter.The Mikro-Cath catheter provides physicians with a simple device to measure hemodynamic cardiac pressures in the human body, promoti ng a bett er understanding of cardiac health for medical research and diagnosti c purposes.

This new catheter has many advantages over traditi onal fl uid-fi lled catheters. These include, high fi delity frequency response > 10 KHz, no fl ushing required, free from moti on artefacts and true pressure readings, regardless of pati ent or bed positi on.

The Mikro-Cath 3.5F model off ers versati le pressure measure-ment for a variety of applicati ons including LVP, RVP, PCWP and aorti c valve gradient pressures. The catheter is indicated for use as a minimally invasive device under short-term lim-ited body contact less than 24 hours. Typical applicati on will be through the femoral artery with the use of an additi onal guiding catheter.

The catheter is shipped sterile to eliminate logisti cal concerns of resterilizati on.

This combinati on of aff ordabil-ity, reduced procedure ti me and sterility allows physicians to bring Mikro-Tip accuracy back into routi ne cath lab procedures.

Contact PMS (Instruments) Ltd on 01628 773233 or email [email protected] for informati on.

Philips Healthcare recently supplied an Allura FD10 dedicated cardiac system to The University Hospital of Wales. The new equipment comes with a host of innovati on including Stent-Boost, a simple, quick and eff ecti ve tool that enhances stent visualisa-ti on and XperSwing dual-axis rotati onal angiography of the coronary arteries. These assist in accurate stent deployment, reduced contrast and radiati on dose therefore potenti ally shortening procedures and eliminati ng additi onal ones.

Philips equipment was selected by UHW because it fully supports all their interventi onal cardiology procedures, including PPCI, Pericar-dial tap and emergency procedures. Penny Lloyd, Superintendent Radiographer says, “We like the manoeuvrability of the system and compact detector head. We also like Philips StentBoost and Xper-Swing. We use StentBoost daily; we fi nd it easy to use and a great tool for post-stent balloon dilati on and for positi oning of second stents.”

A second reason for choosing Philips was outstanding image qual-ity and proven reliability of UHW’s previous Philips system, together with the local engineering support. Above: Shown here (left to right) Ruth Turner, Cardiovascular Sales Special-

ist, Philips Healthcare, Rob Davies, Regional General Manager, Central & West UK, Philips Healthcare, Dr. A. Buch, Consultant Cardiologist, Becky Williamson, Nurse, Irene Crew, Chief ECG Technician, Anna Stevens, Nurse, Penny Lloyd, Superintendent Radiographer, Jane Robinson, Account Manager, Philips Healthcare, Dr. Andrew Wood, Consultant Radiologist and Maggie Hill, Unit Manager.

The catheter is shipped sterile to eliminate logisti cal concerns of

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H-FABP predicts long term mortality in hs-Troponin negati ve ACS pati ents Results from an independent prospecti ve study of 1080 consecuti ve pati ents presenti ng to the ED with suspected ACS has shown that the ischemic cardiac biomarker, heart-type fatt y acid binding protein (H-FABP), substanti ally improves the detecti on of high risk pati ents when Troponin-negati ve, even when a high sensiti vity assay is used. The study, recently published in JACC, was conducted by Profes-sor Alistair Hall & colleagues at Leeds General Infi rmary. Amongst the large and parti cularly signifi cant subgroup of Troponin negati ve pati ents (79.2% of the cohort), a raised H-FABP identi fi ed pati ents at a very high risk for adverse outcomes, independent of age and serum creati nine. H-FABP can now be assessed in combinati on with Troponin, via the new Evidence Multi Stat rapid testi ng instrument - designed & manu-factured by the UK-based diagnosti cs company, Randox.

For more informati on please email: [email protected]

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hypertension, or were 75 years or older). 707 eligible patients were randomly assigned in a 2:1 ratio to percutane-ous closure of the LAA and short term warfarin (45 days) or to long term warfarin (control group, target international nor-malised ratio 2.0-3.0). Efficacy was assessed by a primary composite endpoint of stroke, car-diovascular death, and systemic embolisation. At 1065 patients-years of follow-up the efficacy of percutaneous closure of the LAA with this device was non-inferior to that of warfarin therapy. The device was successfully

implanted in 91% of those in whom implantation was attempted and 86% of these patients (at 45 days of follow-up) were able to stop taking warfarin; followed by initially 6 months of aspirin and clopi-dogrel after randomisation and then long term aspirin monotherapy. For the control group, a therapeutic INR range (2.0-3.0) was achieved 66% of the time. There was a higher rate of adverse safety events in the interventional group than the control group, predominantly a result of peri-procedural complications such as pericardial effusions. As a result of this trial the WATCHMAN device won the recommen-dations of a US Food and Drug Administration (FDA) advisory panel in April 2009, but is awaiting a further study with more safety and efficacy data before being granted full approval by the FDA.

The third occlusion device, the Amplatzer Cardiac Plug (ACP), is con-structed from a nitinol mesh and Dacron and is currently undergo-ing clinical testing.20-22 It comprises of the lobe, which conforms to the inner structure of the LAA; the waist, which acts as an articulat-ing, compliant connection; and the disc, which covers the LAA ori-fice (see figure 3, Images 1 &2). The device is fully recapturable and repositionable if necessary. Unlike the WATCHMAN device patients do not require warfarin therapy, but rather a short period of dual antiplatelet therapy followed by long term aspirin once successful LAA occlusion has been proven by a follow-up TOE.

AF significantly increases the risk of stroke and providing safe and effective anticoagulant therapy can be challenging. Closure of the LAA provides an alternative strategy of stroke prophylaxis in patients with NVAF. Routine implantation, however, does not appear

warranted, though LAA occlusion may be an option in selected patients with a high risk of bleeding complica-tions from anticoagula-tion. It should be noted that these warfarin-ineligible patients were excluded in the PRO-TECT-AF trial. Further larger, adequately pow-ered studies comparing device deployment to optimal anticoagulation are needed to evaluate

the long term safety and efficacy of such occlusion devices. This is especially true in patients with higher CHADS2 scores or with a previ-ous transient ischemic attack or ischaemic stroke.

References:

1. Phillips SJ, Whisnant JP, O’Fallon WM, Frye RL. Prevalence of cardiovas-cular disease and diabetes mellitus in residents of Rochester, Minne-sota. Mayo Clin Proc 1990;65:344–359.

2. Stewart S, Hart CL, Hole DJ, McMurray JJ. Population prevalence, inci-dence, and predictors of atrial fibrillation in the Renfrew/Paisley study. Heart 2001:86:516-21

3. Wolf PA, Abbott RD, Kannel WB. Atrial fibrillation: a major contributor to stroke: the Framingham study. Arch Intern Med 1987;147:1561-64

4. Connolly SJ, Ezekowiz MD et al. Dabigatran versus Warfarin in Patients with Atrial Fibrillation. NEJM 2009;361(12): 1139-51

5. Blackshear JL, Odell JA. Appendage obliteration to reduce stroke in cardiac surgical patients with atrial fibrillation. Ann Thorac Surg 1996;61:755–759.

6. Wongcharoen W, Tsao HM, Wu MH, et al. Morphologic characteristics of the left atrial appendage, roof, and septum: implications for the ablation of atrial fibrillation. J Cardiovasc Electrophysiol 2006;17:951–956.

7. Stollberger C, Schneider B, Finsterer J. Elimination of the left atrial appendage to prevent stroke or embolism? Anatomic, physiologic, and pathophysiologic considerations. Chest 2003; 124:2356-62

Figure 2: WATCHMAN device

Figure 3: Amplatzer cardiac plug

Image 1: LAA (900 on transoesphageal echocardiogram)

Image 2: Occlusion of the LAA by an Amplatzer cardiac plug (90 degrees on transoesphageal echocardiogram)

continues on page 15


This is concordant with other studies we have previously reported, and explanati ons for these fi nding may include; technical diffi culty in delivering eff ecti ve respiratory support, interference of arti fi cial respirati on with delivery of CPR, bystanders being put off by arti fi cial respirati on and effi cacy of chest compressions in venti lati on.

Bobrow and others. JAMA. 2010; 304(13):1447-1454. Coronary Interventi onBare metal stents (BMS) have a signifi cant incidence of resteno-sis and were largely superseded by drug eluti ng stents (DES) that became available in 2002. There was then global concern regarding the risk of stent thrombosis in pati ents with fi rst generati on DES, fol-lowing presentati ons of two meta-analyses at the ESC in Barcelona, in 2006. There was a subsequent reducti on in the use of DES and numerous further studies have been published that have been, on the whole, reassuring. As a result, nati onal guidelines recommended dual anti platelet therapy for a minimum of 12 months in all pati ents receiving DES.

A recent prospecti ve, multi center, Spanish registry of 4,768 ‘real world’ pati ents demonstrated a cumulati ve incidence of defi nite/probable thrombosis for zotarolimus eluti ng stents (ZES – Endeavor / Medtronic) of 1.3% at 1 year and 1.7% at 2 years, and for everolimus eluti ng stents (EES - Xience / Abbott or Promus / Boston) of 1.4% at 1 year and 1.7% at 2 years (p = 0.8 for ZES vs. EES). These fi gures are reassuringly lower than with the fi rst generati on DES, but sti ll emphasise the importance of good stent deployment and adequate dual anti platelet therapy. Interesti ngly, in the subset of pati ents with bifurcati on lesions, ZES signifi cantly increased the risk of stent thrombosis compared to EES. Of course, there are now third genera-ti on, biodegradable polymer, nitric oxide producing and endothelial progenitor capture cell-coated stents available as well.

De la Torre Hernandez and others. JACC Cardiol. Intv. 2010;3;911-19.

Another trial has been reported comparing percutaneous coronary interventi on (PCI) and surgical revascularisati on (CABG) for multi ves-sel disease, but this ti me in pati ents with acute coronary syndromes (ACS). The ACUITY trial was originally designed to compare 3 diff er-ent anti thromboti c regimens in moderate to high risk ACS pati ents (unfracti onated heparin or low molecular weight heparin with a gly-coprotein (GP) IIbIIIa inhibitor, bivalirudin with a GPIIbIIIa inhibitor, or bivalirudin alone). Of the 13,819 pati ents enrolled, 56% (7,789) underwent PCI and 11% (1,539) had CABG. The remaining 33% were treated medically, at the investi gators discreti on. Aft er propensity matching (the latest trendy stati sti cal method to correct for varia-bles) pati ents treated with PCI had lower rates of stroke, myocardial infarcti on, major bleeding, and renal injury than those treated with CABG, with comparable 1-month and 1-year rates of mortality, but more oft en developed recurrent ischemia requiring repeat revascu-larizati on procedures during follow-up.

Ben-Gal and others. JACC Cardiol. Intv.;3:1059-67.

A registry comparing PCI and CABG in left main stem disease has also been reported this month. The ASAN-MAIN (Asan Medical Center-Left Main Revascularizati on) study published 10-year data on 350 pati ents with unprotected left main disease who were treated with either CABG or BMS, and fi ve-year data on 395 pati ents treated with either surgery or a DES (mainly sirolimus eluti ng Cypher stents). Aft er adjustment for variables, results were equivalent between the two methods of revascularisati on, in terms of mortality and a combined end point of death, Q-wave MI, or stroke. However, as with other studies (SYNTAX and COMPARE-MAIN), both BMS and DES pati ents were more likely to require further revascularisati on during follow up. In Europe, as part of the newest European Society of Cardiology guidelines, coronary stenti ng of left main disease is a class IIa, level of evidence B, recommendati on.

Park and others. JACC;56:1366-1375.

References (cont...)

8. Agmon Y, Khandheria BK, Genti le F, Seward JB. Echocardiograph-ic assessment of the left atrial appendage. J Am Coll Cardiol 1999;34:1867–1877.

9. Predictors of thromboembolism in atrial fi brillati on: II. Echocar-diographic features of pati ents at risk. The Stroke Preventi on in Atrial Fibrillati on Investi gators. Ann Intern Med 1992;116:6–12.

10. Transesophageal echocardiographic correlates of thromboem-bolism in high-risk pati ents with nonvalvular atrial fi brillati on. The Stroke Preventi on in Atrial Fibrillati on Investi gators Commit-tee on Echocardiography. Ann Intern Med 1998;128:639–647.

11. Garcia-Fernandez MA, Perez-David E, Quiles J, et al. Role of left atrial appendage obliterati on in stroke reducti on in pati ents with mitral valve prosthesis: A transesophageal echocardiographic study. J Am Coll Cardiol 2003;42:1253–1258.

12. Belcher JR, Somerville W. Systemic embolism and left auric-ular thrombosis in relati on to mitral valvotomy. Br Med J 1955;2:1000–1003.

13. Healey JS, Crystal E, Lamy A, et al. Left Atrial Appendage Occlusion Study (LAAOS): Results of a randomized controlled pilot study of left atrial appendage occlusion during coronary bypass surgery in pati ents at risk for stroke. Am Heart J 2005;150:288–293.

14. Johnson WD, Ganjoo AK, Stone CD, et al. The left atrial append-age: Our most lethal human att achment! Surgical implicati ons. Eur J Cardiothorac Surg 2000;17:718–22.

15. Sievert H, Lesh MD, Trepels T, et al. Percutaneous left atrial appendage transcatheter occlusion to prevent stroke in high-risk pati ents with atrial fi brillati on: Early clinical experience. Circula-ti on 2002;105:1887–1889.

16. 16. Ostermayer SH, Reisman M, Kramer PH, et al. Percutaneous left atrial appendage transcatheter occlusion (PLAATO system) to prevent stroke in high-risk pati ents with non-rheumati c atrial fi brillati on: Results from the internati onal multi -center feasibil-ity trials. J Am Coll Cardiol 2005;46:9–14.

17. 17.Bayard YL, Omran H, Neuzil P, Thuesen L, Pichler M, Rowland E, Ramondo A, Ruzyllo W, Budts W, Montalescot G, Brugada P, Ser-ruys PW, Vahanian A, Piéchaud JF, Bartorelli A, Marco J, Probst P, Kuck KH, Ostermayer SH, Büscheck F, Fischer E, Leetz M, Sievert H. PLAATO (Percutaneous Left Atrial Appendage Transcatheter Occlusion) for preventi on of cardioembolic stroke in non-anti -coagulati on eligible atrial fi brillati on pati ents: results from the European PLAATO study. EuroInterventi on. 2010;6:220-6.

18. 18. Sick PB, Schuler G, Hauptmann KE, et al. Initi al worldwide experience with the WATCHMAN left atrial appendage system for stroke preventi on in atrial fi brillati on. J Am Coll Cardiol 2007;49:1490–1495.

19. 19. Holmes DR, Reddy VY, Turi ZG, Doshi SK, Sievert H, Buchbind-er M, Mullin CM, Sick P; PROTECT AF Investi gators. Percutane-ous closure of the left atrial appendage versus warfarin therapy for preventi on of stroke in pati ents with atrial fi brillati on: a ran-domised non-inferiority trial. Lancet. 2009; 374:534-4.

20. 20. Park JW, Bethencour A, Sievert H, Santoro G, Meier B, Walsh K,. Lopez-Minquez JR, Meerkin D, Ormerod O, Leithäuser B. Left atrial appendage closure with Amplatzer cardiac plug for preven-ti on of stroke in atrial fi brillati on – initi al European Experience. Eur. Heart J. 2010;12(suppl A):S14

21. 21. Rodés-Cabau J, Champagne J, Bernier M. Transcatheter closure of the left atrial appendage: initi al experience with the Amplatzer cardiac plug device. Catheter Cardiovasc Interv. 2010;76: 86-92.

22. 22. Bass JL. Transcatheter occlusion of the left atrial appendage--experimental testi ng of a new Amplatzer device. Catheter Car-diovasc Interv. 2010; 76:181-5.

.....conti nued from page 13


PHARM

A

on any class 1 or 3 antiarrhythmics, this should be stopped before starting dronedarone. No dose adjustment is necessary in the elderly population with renal impairement (except contraindication in severe renal impairement of creatinine clearance of less than 30 ml/min). No dose adjustment is necessary in patients with mild to moderate hepatic impairement but contraindicated in severe hepatic failure.

The dose should not be taken with grapefruit juice as it increases dronedarone exposure. Doses of digoxin should be reduced by 50% if concurrently used with dronedarone. There are a number of other clinical drugs interactions. Pharmacists should refer to the SPC to ensure safety of polypharmacy when they have a patient on dronedarone.

The most frequent adverse effects include an elevated blood cre-atinine level and prolongation of QT interval. Other common adverse events may include diarrhoea, nausea, vomiting, fatigue and asthenia.

Clinical effectiveness from trials

The four main clinical trials (ATHENA, EURIDID, ADONIS and DIO-NYSOS) demonstrated the superior efficacy of dronedarone over placebo but also showed less efficacy against amiodarone and other antiarrhythmic agents.

EURIDIS (EURopean trial In atrial fibrillation patients receiving Dronedarone for the maIntenance of Sinus rhythm) and ADONIS (American-Australian-African trial with DronedaONe In atrial fibril-lation patients for the maintenance of Sinus rhythm) were phase III multicentre, parallel, randomised double blind, placebo-controlled trials of the same design and were reported together. A total of 612 patients were recruited into the EURIDIS trial and 625 patients into the ADONIS trial. Both dronedarone and placebo were given in addi-tion to standard first-line therapy of beta blocker and anticoagula-tion. Patients had paroxysmal or persistent atrial fibrillation or atrial flutter. The primary endpoint was the first documented recurrence of AF lasting at least 10 minutes. Secondary endpoints included symptoms related to AF during recordings and mean ventricular rate during first recurrence. The results showed that fewer people in the dronedarone arm had AF recurrence at 12 months than pla-cebo (p<0.001). These trials also reported a lower ventricular rate in the dronedarone compared to placebo.1 Symptomatic recurrence occurred in 37.1% and 47.5% of patients treated with dronedarone or placebo respectively (p=0.006).

ATHENA was also a phase III multicentre, parallel, randomised, dou-ble blind placebo controlled trial of 4,628 patients. Both dronedar-one and placebo were given in addition to standard first-line therapy of beta blocker and anticoagulation. Patients had paroxysmal or persistent atrial fibrillation or atrial flutter with at least one of the following additional risk factors for a major cardiovascular event. The primary endpoint was first hospitalisation due to cardiovascu-lar events or death from any cause.2 A total of 31.9% of patients in

the dronedarone group experienced the primary outcome compared to 39.4% in the placebo group (p<0.001). The results were driven by a lower hospitalisation rate in the dronedarone group compared to placebo. This trial reported lower cardiovascular mortality in the dronedarone group compared with placebo but no statistically sig-nificant difference in all cause mortality.2,3

DYONYSOS was a phase III randomised double blind trial of 504 patients, comparing dronedarone with amiodarone. Patients had paroxysmal or persistent atrial fibrillation or atrial flutter in whom cardioversion and antiarrhythmic treatment were indicated plus anticoagulation. The primary endpoint was treatment failure as defined by recurrence of AF or premature study drug discontinuation for intolerance or lack of efficacy. The primary endpoint occurred in 73.9% of patients treated with dronedarone compared to 55.3% for amiodarone (p<0.001). The absolute difference in primary endpoint between dronedarone and amiodarone was 18.5%. AF recurred in 36.5% in the dronerdarone compared to 24.3% in the amiodarone group. The trial reported fewer deaths in the dronedarone group compared to amiodarone, but NICE has drawn no conclusion about the relative effect of dronedarone and amiodarone on mortality due to short follow up of the trial and the small number of deaths in the study.4

NICE Audit support

NICE has also made available an audit tool (www.nice.org.uk/TA197) in order to support measuring current practice in using dronedarone for the treatment of non-permanent AF against the recommenda-tions made. The standards set against the guidelines are 100% com-licance but NICE recommends that the standards can be flexible and need local discussions with the specialist clinicians.

References1. Singh BN, Connolly SJ, Crijns HJ, et al. Dronedarone for maintenance

of sinus rhythm in atrial fibrillation or flutter. N Engl J Med 2007; 357: 987-999.

2. Hohnloser SH, Crijns HJ, van Eickels M, et al. ATHENA Investigators. Effect of dronedarone on cardiovascular events in atrial fibrillation. N Engl J Med 2009; 360: 668-678.

3. Hohnloser SH, Crijns HJ, van Eickels M, et al. ATHENA Investigators. Dronedarone in patients with congestive heart failure: Insights from ATHENA. European Heart J July 2010; 31 (14): 1717-21

4. Letteuzey JY, De Ferrari GM, Radzik D, et al. DIONYSOS Investigators. A short term, randomised, double blind, parallel group study to evaluate the efficacy and safety of dronedarone versus amiodarone in patients with persistent atrial fibrillation. Journal Cardiovasc Electrophysiol, June 2010; 21 (6): 597-605.


We are the fi rst publicati on to be endorsed for CPD by the Soci-ety of Radiographer’s in the UK. We are classed as a varied and topical journal suited to the needs of cardiology radiographers and other practi ti oners in cardiac imaging. May support outcomes 1-14 of CPD Now.

Using the ACIST for TAVI’s at the Harley Street ClinicThe Harley Street Clin-ic recently performed their fi rst TAVI case with Drs Ghada Mikhail and Iqbal Malik. It is thought that this was the fi rst of its type in a private medical insti -tuti on using the ACIST Contrast Management System, which allows for precise and variable fl ows of contrast for both small and larger volumes. Cath Lab Manager Stephen Weymouth said, ‘the whole case went very well and we were pleased that we were able to use the ACIST device for out fi rst TAVI. It made the case quicker as we did not have to set up a separate injector, and safer as it is a closed system so there is less chance of air entering the pati ent’. The Harley Street Clinic is a cardiac centre of excellence which con-ti nues to invest in its experienced consultants, staff and the latest technology. The ACIST provides many advantages for the cardiologist, includ-ing reduced contrast usage and creati ng a safer environment due to radiati on reducti on and its air detectors.

For more informati on, please visit www.apc-cardiovascular.co.uk or call 01270 216142

CoreValve Receives FDA Approval for Evaluati onOn 15th October 2010, Medtronic, Inc. announced U.S. Food and Drug Administrati on (FDA) conditi onal approval for its Investi gati onal Device Exempti on (IDE) applicati on and piv-otal clinical trial protocol to begin evaluati ng the Medtronic CoreValve System for transcatheter aorti c valve implantati on (TAVI). As we featured in the previous editi on of Coronary Heart, the CoreValve system is designed to provide a mini-mally invasive, non-surgical treatment opti on for pati ents

with symptomati c, severe aorti c stenosis who are at high risk, or are ineligible, for open-heart surgery.

The CoreValve System is not yet commercially available in the US, however since March 2007 when it obtained the CE Mark,

it has been implanted in more than 12,000 pati ents in 34 countries

outside the US.



outside the US.

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Another EP teaching opportunity occurring soon is a BARD® EP Fellows Course, which takes place during the aft ernoon of 21st November, preceding Europe AF 2010, London. The Deducti ve Electrophysiology course has an Internati onal EP Faculty. Registrati on for the Fellows Course is free, and att endees can also get a special discounted registrati on fee to att end Europe AF 2010. Pre registrati on for the Fellows Course is required.

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ContentsNov / Dec 2010


Site VisitUnited Kingdom

Completed with the assistance of Volcano

Raigmore Hospital is located in Inverness, a rapidly growing city in northern Scotland. Located 254km north of Edinburgh, and 903km north of London, the city is situated at the mouth of the River Ness, which fl ows from the nearby Loch Ness. The populati on is approximately 57,000, with two languages spoken, being English and Scotti sh Gaelic, and is ranked fi ft h out of 189 Briti sh citi es for quality of life.

What are the sizes of your Cardiology Department and Hospital?

Raigmore Hospital is the 600 bedded regional centre for the High-lands of Scotland. Within the Cardiac Unit there is a 6 bedded CCU and 16 bedded step down ward. There is also a dedicated cardiac rehab unit. (The Highland Heartbeat Centre)

What is the geographical intake area and populati on served by your hospital?

NHS Highland covers 41% of the land mass of Scotland, same size as Wales! 300,000 people live in the area but there is a large tourist infl ux. The dispersed populati on makes this one of the least densely populated areas in Europe with some of the most remote pati ents and many island communiti es.

How many staff ? Roles?

We have recently expanded to 4 consultants (2 PCI trained) as well as a fully staff ed CCU, Cath Lab and Cardiac Investi gati ons unit. Cardiac rehab teams are present throughout the area and there are good links with our local district and community hospitals. Types of procedures?

Other than EP, there is a full range of cardiac services available including diagnosti c angiograms, PCI, bradycardiac pacing, ICD, TTE, TOE, cardiac CT, cardiac MRI, and MPS. Types of equipment used?

The current lab used is a Philips modular lab but in March 2011 our new lab complex will be opened with GE cath labs, integrated Vol-cano for IVUS and pressure wire.

Raigmore HospitalRaigmore HospitalOld Perth RoadInvernessIV2 3UJUnited Kingdom

RaigmoreHospital


Charlie Bloe: Senior Nurse NHS Highlands

Where did you train?

I undertook the BSc Social Sciences and Nurs-ing Studies at the University of Edinburgh between 1979 and 1984. At that ti me it was also possible to undertake the Nati onal District Nursing Certi fi cate so I completed that training before job hunti ng. My Criti cal Care qualifi ca-ti ons were obtained at the Western Infi rmary school of Nursing in Glasgow.

Why did you decide to specialise in Cardiology?

It was almost by default! I had att ended an interview at Forth Valley Acute Hospitals for a job as staff nurse in a general medical ward. At a pre interview visit the Nursing Offi cer, Greta Given, showed me the Medical HDU and combined CCU facility where a vacancy also existed. I was off ered both opti ons and opted for the CCU role. I guess that I therefore owe my career in Cardiology to Greta, who has sadly since passed away.

You spent many years away from clinical practi ce to set up your own successful business, Charles Bloe Training. What brought you back to clinical practi ce and what is your current role?

I’ve always had a passion for teaching but preferred the fl exibility of undertaking ad hoc freelance consultancy work as opposed to a Uni-versity based post. I established Charles Bloe Training 13 years ago and it quickly became very successful. We deservedly developed a reputati on for providing quality clinical updates for nurses and over a period of ti me I recruited over 30 freelance consultants to deliver the training across the UK and beyond. I also had aspirati ons to explore the feasibility of web based training and have subsequently devel-oped a portf olio of 30 online clinical courses. The ECG in Acute Coro-nary Syndrome course was awarded fi rst place at the Briti sh Journal of Cardiac Nursing awards in 2008 for Innovati on in Educati on. With so much to do I decided to leave clinical practi ce in 2000 to focus on the training business full ti me.

During that period I relocated to the Scotti sh Highlands and in 2008 I happened to meet Prof. Steve Leslie who I had previously worked with at Falkirk Royal Infi rmary. He informed me of the vacant Clinical Ward Manager post at Raigmore Hospital’s CCU facility. Although it was not my intenti on to return to the ‘sharp end’ of cardiac care I was excited by the challenges that Steve highlighted and the vision he had for the service. So here I am!

I’ve only been in post for a litt le over 2 years and it has been a great move. I have a fantasti c group of staff who have demonstrated a tre-mendous desire to further develop their roles and we’ve made enor-mous strides in my ti me here. The staff have been a real credit to me and to themselves.

I believe that the service we provide for cardiac pati ents in NHS Highland is very personalised. We have established a good number of nurse-led initi ati ves such as rapid access chest pain and have uti -lised telemedicine to dramati cally improve pre hospital reperfusion with thrombolysis. ECG’s are transmitt ed from pati ent’s homes, that can be in excess of 2-3 hours away, to the CCU and this has resulted in most eligible pati ents receiving pre hospital thrombolysis. I was delighted when the nurses and Paramedics of NHS Highlands won an award in the ‘Changing for the Bett er’ category at this years staff awards for their achievements in this area.

InterviewCardiac Nursing

Mr Dennis SandemanNursing Consulti ng EditorChest Pain Nurse SpecialistNHS Fife, Trustee of the Scotti sh Heart and Arterial Risk Preventi on (SHARP) charity.

Charlie Bloe (pictured on the right) receives “Innovation through Education” award at the Cardiac Nursing awards in 2008


How do you believe the integrated Volcano Multi-modality system will benefit your new Catheter Lab?

The Volcano integrated system provides a unified platform includ-ing FFR and IVUS and is integrated with the DICOM System, meaning that all our FFR & IVUS reports are consolidated with the angiograms. This integration assists our Cath Lab Staff as it ensures the workflow in the lab is much smoother and importantly time saving, without the need to bring in different pieces of kit for each procedure. The other advantage means they only need to be trained on one system for all modalities. Having this integrated system will also allow us to take advantage of the future technologies that Volcano are currently developing, including Forward Looking IVUS (FLIVUS) & OCT.

How many procedures are performed a year?

Our lab is projected to undertake approximately 1000 angiograms this year. Over 150 PCI’s were performed in the first 4 months since starting PCI in May 2010, thus we predict we will undertake around 350 in the first year. IVUS and pressure wire are important tools – we performed 19 IVUS and 7 pressure wire studies in the first few months. What is the approximate percentage of cath lab cases performed radially compared with femorally?

85 percent are radial. Does your department offer a Primary Angioplasty Service? If yes, what have been some of the challenges setting it up? If not, is this planned for the future?

Due to the dispersed nature of our population and the presence of only 2 PCI cardiologists, the development of a PPCI service will be a challenge for the cath lab and the ambulance service. Currently we operate a mandated ECG telemetry service to the ambulance ser-vice - where ECGs are telemetered for prehospital thrombolysis. At

present over 90% receive thrombolysis. Overall our PHT rate is 60%. Discussions are under way to offer PPCI to the 60% of the population who live within 1 hour drive time of the lab. Are any of your staff cross-trained (generic workers)? Future?

No, but this is something we are actively looking at to overcome the smaller number of staff in each discipline. This should allows us greater flexibility when opening the lab out of hours.

What new procedures / techniques have you implemented into the department recently? Future?

PCI has been the main focus this year but we have been lucky to attract an established consultant (Peter Clarkson) who is proficient in CRT, and we hope to start this service soon.

What are the benefits to patients attending your facility?

The development of on-site PCI has had an enormous benefit to patients. While we have not developed a PPCI service yet, several patients have had rescue or primary PCI within the cath lab operating times. The treatment of NSTEMI patients has been greatly improved and the turn-over of patients on our cardiac step down ward has quadrupled since the start of the PCI service.

How is your inventory managed?

Stock at present is a paper system with Excel spread sheet support, and a dedicated store person. We are looking into costing and imple-menting a bar code system that will have set levels, max/min, and can re-order with a link to automatic ordering when these levels are at a minimum.

Cath Lab Staff (from left): Dr Jamie Smith, Isobel Adams (Cath Lab Manager), Prof Steve Leslie, Karen Hercher (Cath Lab Nurse), Morag Nicol (Radiographer),

and Margaret-Ann Martin (Physiologist)


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We have a fi rst class cardiac rehabilitati on service located within the purpose built Highland Heartbeat Centre. Add in nurse-led services in electi ve cardioversion, ICD support and pre and post coronary angiography and we have what we believe is a mini centre of excel-lence serving a much dispersed populati on.

I have also taken on the role of Clinical Lead for the cardiac MCN. We are so dependent on our primary care colleagues to deliver pre hospital cardiac care and this post helps me understand the issues in primary care and foster closer links with the GP’s and Paramedics on who we depend so much. How has the world of cardiology nursing changed since you were away?

Had I not been involved in providing clinical updates I suspect that the changes would have seemed dramati c in the 8 years I was away from clinical practi ce.

The most obvious change in coronary care in the last decade or so has been the emergence of PCI as the preferred reperfusion strategy in STEMI pati ents.

There has also been a welcome increase in nurse-led initi ati ves and a greater acceptance of this support by our medical colleagues. It is reassuring that we now seldom read publicati ons directly comparing the clinical abiliti es of nurses versus doctors. That wasn’t the case 10 years ago.

It has taken some ti me but the emergence of telemedicine has allowed collaborati ve decision-making between paramedics and CCU nurses based on 12-lead ECG telemetry that expedites the delivery of pre hospital thrombolysis in STEMI. It is important that cardiac nursing embraces new technologies and this is a prime example of that. We’ve been tremendously successful in improving pre hospital thrombolysis delivery by paramedics and GP’s uti lising this technol-ogy coupled with nursing support. It has increased from approx. 20% to over 75% in the last year.

You must have the catheter lab which is the furthest north in the UK. What are the challenges of having a cardiology centre which is based so remotely and how have you and your colleagues in Raigmore dealt with these challenges?

Yes that is a major issue. We have a populati on of litt le over 250,000 but they are dispersed over a geographical area that’s bigger than Belgium! Add in remote country roads and prett y harsh winter weather and you begin to understand the challenges in providing acute cardiac care in NHS Highland.

We have two interventi onal cardiologists in Prof. Steve Leslie and Dr. Jamie Smith. We’ve had a diagnosti c angio service for some years and commenced PCI in May 2010. However with our relati vely small populati on and limited interventi onal capacity we have to take a

pragmati c approach to opti mal reperfusion for STEMI pati ents. Given the long transportati on ti mes it is likely that coronary throm-bolysis will remain our primary reperfusion strategy and that makes the collaborati on between paramedics & GP’s and CCU even more important. The GP’s and paramedics have a pivotal role to play here. However as our service develops we will examine where and when it is feasible to off er PPCI to those pati ents that can be transported here within required ti me limits.

We may have the most remote catchment area in Europe – but we can also boast the most scenic! It’s also a great place to live and work with so many initi ati ves coming to fruiti on. Through necessity we’ve developed roles and practi ces that are the envy of many ‘big centres’.

What do you do away from work eg hobbies etc...?

What ti me away from work?? Although I have a clinical director who runs my training organisati on I remain as Managing Director and Clin-ical Lead, so I am sti ll required to provide regular input there.

I’ve relocated to a wonderful part of Scotland and so get out and about the hills as oft en as I can. I am forever hopeful that my golf handicap may come down, although there is no real cause for hope there!

CardiologyHD.comSee our Management Hot Topics online today:

• Surviving the Government Spending Cuts

• Should Food/Gift s from companies be banned?

• Hats and masks in the cath lab?

• High Radiati on Dose Protocols

• On-call Reimbursements

• Radiographer Uti lisati on in EP

• Are MBA’s a good idea?

• Non-Professional Staff

• Multi -Skilling in the Cath Lab

• Future Changes?


How does the lab handle haemostasis?

As the majority of our cases are radial the TR band is our main meth-od. For those pati ent requiring femoral puncture we use either angi-oseal or exoseal depending on the pati ent situati on.

What measures has the department implemented to cut costs?

We are conti nually seeking for competi ti vely price products. Further-more approximately 50% of our PCI cases will be undertaken as day case procedures and this has a cost saving.

What kind of training can new employees expect to receive?

Staff new to the cardiology DCU/Cath Lab can expect to be supernu-mery initi ally and have an appointed member of staff as their mentor to support them in the early stages of learning. They assist with new procedures, guidelines and protocols for the safe delivery of high standards of care. A training pack is given to each member of staff covering anatomy and physiology of the heart plus cardiac interven-ti ons, angiograms, pacing, PCI, ETT, MPS and cardiac rehab. Once familiarised with daycase procedures, and protocols, staff are inte-grated into cath lab working, observing initi ally, followed by scrub-bing in with a senior member of staff . Consultant input in the cath lab also contributes in training staff as scrub nurses, parti cularly as second operators for PCI, with cath lab manager support.

What kinds of conti nuing educati on programs are available to staff ?

We are fortunate at Raigmore to have Charlie Bloe from CB train-ing as our CCU ward manager. Training programs for nurses include, online educati on programmes for ACS, drug calculati ons, IABP, ECG recogniti on and thrombolysis training days. We have an annual con-ference, Heart of the Matt er which is well att ended by those inter-ested in cardiac care in the Highlands. Isobel Adams, our cath lab sister joined us this year and brings great experience from James Cook Hospital in Middlesbrough, which has been extremely valuable when setti ng up the service.

What kinds of competency checks do staff have to undergo once employed?

Competencies for staff have been developed and implemented as a means to assess the knowledge gained by staff during training, where extra support is needed, and to deem a member competent in a parti cular area. For example, the following are assessed by the cath lab manager/clinical educator: pati ent safety and risk, through check lists, orientati on (to know where equipment is and what it’s for), procedures, theoreti cal and practi cal knowledge. A new com-petency being developed is a log for staff covering scrub and second operator in the cath lab, fl ooring (scout nursing), and FFR/IVUS. This will be assessed every 3 months.

How do you deal with late fi nishing of cases?

Currently PCI is limited to morning working only – however as pre-dicted this is insuffi cient capacity, and discussions are ongoing to cre-ate an oncall staff to allow PCI in the aft ernoons.

What is your policy for company reps within the labs?

Reps are encouraged to visit BUT in line with BCIS recommendati ons are only allowed in the lab when specifi c staff training is required.

Reducing radiati on dose is a high priority in the cath labs. What techniques are employed by your radiographers to ensure dosage during cases is kept to a minimum? Also what is the maximum dose limit a pati ent can receive in your labs before it is recorded in their notes, and what is the follow-up process?

Slick PCI operators is clearly the key to reducing radiati on dose! Low dose screening and aquisiti on techniques are used with low screening and aquisiti on ti mes, and collimati on where possible.

We also ensure we use appropriately trained specialist radiographers. All staff must wear correct lead equivalent personal protecti on and radiati on monitoring badges. Use of lead shielding on equipment and the numbers of staff in the lab are kept to a minimum when using radati on. Radiographers noti fy cardiologists when skin dose is 2 Grays (200 DGS). Cardiologists consider staged procedures or where possible change the angle of the tube. The medical physics depart-ment is informed when a high dose occurs, and the Cardiologist is responsible for the medical follow up.

What are the advantages for SpR’s training at your facility?

We provide a truly consultant delivered service (due to lack of SpRs) thus a trainee at Raigmore will be ensured of excellent supervision during their training and exposure to a range of cardiac pati ents.

What is the best part of working at your facility?

The team eff ort to establish PCI has been a great bonding experi-ence. The enthusiasm and skills of the cath lab staff have been par-ti cularly uplift ing, and the transformati on of the pati ent fl ow in the CCU and cardiology ward has only been achievable due to the huge eff ort of the nurses and support staff in these areas.

CardiologyHD.comSee our other Site Visits online today:

• The London Independent Hospital

• St Bartholomew’s Hospital (Barts)

• Hammersmith Hospital

• Kings College Hospital

• Guy’s & St Thomas’ NHS Foundati on Trust

• The Wellington Hospital

• Northampton General Hospital

• West Hertf ordshire Hospitals NHS Trust

• Essex Cardiothoracic Centre

• Freeman Hospital

• The Liverpool Heart and Chest Hospital

• Manchester Royal Infi rmary

• Southampton General Hospital

• East Surrey Hospital

• Royal Bournemouth Hospital

• Royal Cornwall Hospital

• Princess of Wales Hospital

• Waterford Regional Hospital (Ireland)

• Christchurch Hospital (New Zealand)

Plus many more from Australia, New Zealand, and the USA.

LatestProductNews

5

Cardiac Surgeon Interview 10

14Journals

16

18

Management Assistance- Three Top Tips

19

20

24

Site Visit- Raigmore Hospital

Nursing Interview- Charles Bloe

ECG Challenge Answer +

26Events Calendar

27

- Mr Babat discusses TAVI’s

Raigmore HospitalSite Visit

Mr Babat discusses TAVI’s

10

20

Left Atrial Appendage Occlusion

12

ECG Challenge

Future Tech News

Pharma

- with Sophie Blackman

- Dronedarone

- A Review


How to get in touch@ Email

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Free Distributi on of 2800 copies to named individuals within cardiology in UK/Ireland.Distributed to all cardiology departments (invasive and non-invasive) and cardiologists.

For your free copy subscribe on our website at www.cardiologyhd.com.

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Pharmaceuti cal Editor

Head of Clinical Pharmacy, Royal Berkshire Foundati on Trust & Nati onal Non-medical Prescribing Facilitator, Nati onal Prescribing Centre.

Mr Tim LarnerDirector / FounderPrevious Cardiac Radiographer Manager in Australia, & Senior Radiographer at multi ple sites in the UK.

Dr Magdi El-OmarLead Consulti ng EditorConsultant Cardiologist, Manchester Heart Centre, Central Manchester University Hospitals NHS Foundati on Trust

Dr Richard EdwardsConsulti ng EditorConsultant Cardiologist, Freeman Hospital, Newcastle-upon-Tyne Hospitals NHS Trust

Mr Ian WrightEP Consulti ng EditorTechnical Head EP, St Mary’s Hospital, Imperial College Healthcare NHS Trust



Dr Simon RedwoodConsulti ng EditorConsultant Cardiologist & Director of the Cath Labs at Guy’s & St Thomas‘ NHS Foundati on Trust

Dr Rodney FoaleConsulti ng EditorConsultant Cardiologist, Imperial College Healthcare NHS Trust

Mr Adam LunghiEcho Consulti ng EditorSenior Echo ManagerCVS - CardioVascular Services, Australia


Ms Sophie BlackmanManagement & CRM Consulti ng EditorHead of Clinical Cardiac Physiology, West Hertf ordshire NHS Trust


Latest Product NewsAbbott ’s Groundbreaking Bioresorbable Vascular Scaff old Implanted in First UK Pati entAbbott enrolled its fi rst UK heart pati ent at the University Hospi-tals of Leicester as part of an internati onal trial to evaluate the per-formance of the company’s revoluti onary bioresorbable vascular scaff old (BVS) - the fi rst drug-eluti ng device of its kind designed to open up a blocked artery without leaving behind a permanent met-al implant in the blood vessel. This potenti al restorati on of vessel functi on makes Abbott ’s BVS unique in the treatment of coronary artery disease.

The ABSORB EXTEND trial, which will enrol pati ents from 100 centres worldwide, reinforces Abbott ’s commitment to research and devel-op innovati ve devices for vascular care. “The BVS promises to be an important next step in the treatment of coronary artery disease, and Abbott is committ ed to making this revoluti onary technology a clini-cal reality,” said Sue Hudson, General Manager, Abbott Vascular, UK & Ireland.

CYPHER Stent 10 Year Follow-upCordis Corporati on announced at the European Society of Cardiology in Stockholm on August 31st that the results of follow-up tests under-taken ten years aft er the fi rst pati ent was treated with a CYPHER® Sirolimus-eluti ng coronary stent have proven outstanding long-term effi cacy and safety.

The fi rst pati ent was treated in 1999 with the CYPHER® stent at the age of 75 aft er her coronary angiography showed a signifi cant, single, de novo lesion in the proximal left anterior descending (LAD) artery and under-went further invasive follow-up revealing a sustained anti -proliferati ve eff ect of the CYPHER® stent by both angiography and IVUS examinati on in 2009. The pati ent also underwent an opti cal coherence tomography (OCT) assessment which revealed a complete coverage of over 90% of the analysed struts. The follow-up proce-dure was broadcast live during the 2009 meeti ng of the Lati n America Society of Interventi onal Cardiology (SOLACI, Rio de Janeiro - Brazil).

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Abbott ’s New Bioresorbable Vascular Scaff old

>>>

Balloon-like Handling with the New Resolute Integrity StentIn early September 2010, cardiologists from Southampton General Hospital were the fi rst in Europe to implant Medtron-ic’s new Resolute Integrity Stent System, the latest drug-elut-ing stent to hit the market in Europe. The Resolute features a new advanced design, based on conti nuous sinusoid tech-nology, allowing it to be more fl exible than other stents. This improves deliverability to navigate through tortuous arteries easily, and once in place mould more successfully to the ves-sel walls.

Dr Iain Simpson, the Consultant cardiologist who performed the fi rst procedure stated “The new stent is more fl exible for getti ng around twisty arteries, giving us another opti on when treati ng pati ents with coronary heart disease or those who have suff ered a heart att ack”.

Recently other cardiologists in Europe have given the stent rave reviews. Dr Hamm in Germany stated, “The Resolute Integrity is the fi rst stent that feels like a balloon.” Whilst Dr Brunner in

Austria stated, “This is simply the best stent on the market.”

For more informati on contact your Medtronic representati ve


Data from Multi ple Clinical Trials of OrbusNeich’s Genous™ Bio-engineered R Stent™ Demonstrate Safety and Eff ecti veness Across Challenging Pati ent Subsets as Presented at TCT 2010 in WashingtonThe results presented include:

• Subset analyses of the global e-HEALING registry show that the Genous Bio-engineered R stent is safe and eff ecti ve in diabeti c pati ents, elderly pati ents over the age of 80 and in pati ents who stopped dual anti platelet therapy (DAPT) at 30 days.

• Twelve-month follow-up results from the JACK-EPC clinical trial, an investi gator-initi ated, randomized trial that compared the Genous Bio-engineered R stent with bare metal stents (BMS) in pati ents with acute coronary syndromes, showed the major adverse cardiac event (MACE) rate in Genous Bio-engineered R stent treated pati ents was 13.3 percent compared to 23.3 per-cent in BMS pati ents.

• Thirty-day follow-up opti cal coherence tomography (OCT) evalu-ati ons from 13 pati ents treated with the Genous Bio-engineered Cobalt Chromium Stent showed complete endothelializati on in majority of pati ents at 30 days post-implantati on.

For more informati on, visit www.OrbusNeich.com.

LEADERS Three-Year Results Suggest Improved Safety and Effi cacy of BioMatrix Flex™ over Cypher® Select™Three-year results from the LEADERS trial, showing a conti nuing pos-iti ve trend towards a safety and effi cacy benefi t for BioMatrix Flex™ compared to Cypher® Select™, were presented at TCT 2010.

In the all-comers study populati on there were similar outcomes for BioMatrix Flex, Biosensors’ Biolimus A9™-eluti ng stent system with abluminal biodegradable polymer, and Cypher Select, Johnson & Johnson’s sirolimus-eluti ng stent system with a durable polymer, in respect of MACE (major adverse cardiac events) at three years. There was a diverging trend towards a lower rate of MACE in pati ents treat-ed with BioMatrix Flex versus those treated with Cypher Select when compared to both one and two year results.

Occurrence of very late stent thrombosis (VLST) events was low: a cumulati ve 0.2% for BioMatrix Flex out to three years, compared with 0.9% for Cypher Select observed within the same period.

Image courtesy Biosensors

4

Nine-month results from PLATINUM clinical program presented at TCTBoston Scienti fi c Corporati on announced data from its PLATINUM QCA study, which is designed to evaluate the PROMUS Element™ Everolimus-Eluti ng Plati num Chromium Coronary Stent. The results provided nine-month QCA and IVUS data supporti ng the safety and effi cacy of the PROMUS Element Stent.

Analysis of the data was presented by Ian Meredith, at TCT in Washington, D.C who stated, “The nine-month angio-graphic and IVUS data from the PLATINUM QCA study are impressive and show the acute performance advantages of the plati num chromium PROMUS Element Stent. With the same drug and polymer loading and comparable release kineti cs as the PROMUS® Stent, the PROMUS Element Stent achieved similar late loss (0.17 mm ± 0.25 mm) and signifi -cantly bett er stent appositi on. These results give me great confi dence in the transfer-ability of the everolimus drug and its proven clinical outcomes, as well as the potenti al benefi ts of the new plati num chromium alloy.”

Contact your local Boston Scienti fi c representa-ti ve for more details.

This Stent Featured in Edition 225

6


New Millar Mikro-Cath™ Disposable Pressure Catheter.The Mikro-Cath catheter provides physicians with a simple device to measure hemodynamic cardiac pressures in the human body, promoti ng a bett er understanding of cardiac health for medical research and diagnosti c purposes.

This new catheter has many advantages over traditi onal fl uid-fi lled catheters. These include, high fi delity frequency response > 10 KHz, no fl ushing required, free from moti on artefacts and true pressure readings, regardless of pati ent or bed positi on.

The Mikro-Cath 3.5F model off ers versati le pressure measure-ment for a variety of applicati ons including LVP, RVP, PCWP and aorti c valve gradient pressures. The catheter is indicated for use as a minimally invasive device under short-term lim-ited body contact less than 24 hours. Typical applicati on will be through the femoral artery with the use of an additi onal guiding catheter.

The catheter is shipped sterile to eliminate logisti cal concerns of resterilizati on.

This combinati on of aff ordabil-ity, reduced procedure ti me and sterility allows physicians to bring Mikro-Tip accuracy back into routi ne cath lab procedures.

Contact PMS (Instruments) Ltd on 01628 773233 or email [email protected] for informati on.

Philips Healthcare recently supplied an Allura FD10 dedicated cardiac system to The University Hospital of Wales. The new equipment comes with a host of innovati on including Stent-Boost, a simple, quick and eff ecti ve tool that enhances stent visualisa-ti on and XperSwing dual-axis rotati onal angiography of the coronary arteries. These assist in accurate stent deployment, reduced contrast and radiati on dose therefore potenti ally shortening procedures and eliminati ng additi onal ones.

Philips equipment was selected by UHW because it fully supports all their interventi onal cardiology procedures, including PPCI, Pericar-dial tap and emergency procedures. Penny Lloyd, Superintendent Radiographer says, “We like the manoeuvrability of the system and compact detector head. We also like Philips StentBoost and Xper-Swing. We use StentBoost daily; we fi nd it easy to use and a great tool for post-stent balloon dilati on and for positi oning of second stents.”

A second reason for choosing Philips was outstanding image qual-ity and proven reliability of UHW’s previous Philips system, together with the local engineering support. Above: Shown here (left to right) Ruth Turner, Cardiovascular Sales Special-

ist, Philips Healthcare, Rob Davies, Regional General Manager, Central & West UK, Philips Healthcare, Dr. A. Buch, Consultant Cardiologist, Becky Williamson, Nurse, Irene Crew, Chief ECG Technician, Anna Stevens, Nurse, Penny Lloyd, Superintendent Radiographer, Jane Robinson, Account Manager, Philips Healthcare, Dr. Andrew Wood, Consultant Radiologist and Maggie Hill, Unit Manager.

The catheter is shipped sterile to eliminate logisti cal concerns of

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H-FABP predicts long term mortality in hs-Troponin negati ve ACS pati ents Results from an independent prospecti ve study of 1080 consecuti ve pati ents presenti ng to the ED with suspected ACS has shown that the ischemic cardiac biomarker, heart-type fatt y acid binding protein (H-FABP), substanti ally improves the detecti on of high risk pati ents when Troponin-negati ve, even when a high sensiti vity assay is used. The study, recently published in JACC, was conducted by Profes-sor Alistair Hall & colleagues at Leeds General Infi rmary. Amongst the large and parti cularly signifi cant subgroup of Troponin negati ve pati ents (79.2% of the cohort), a raised H-FABP identi fi ed pati ents at a very high risk for adverse outcomes, independent of age and serum creati nine. H-FABP can now be assessed in combinati on with Troponin, via the new Evidence Multi Stat rapid testi ng instrument - designed & manu-factured by the UK-based diagnosti cs company, Randox.

For more informati on please email: [email protected]

9


ProtecX Medical Ltd launches new website.ProtecX is pleased to announce the launch of its new website due to go live at the end of November 2010.

We are proud to introduce this exciti ng development which as well as allowing customers to view our full range of radiati on protecti on and related products, also incorporates a tool to allow customers to request quotati ons on one or many of the products in our range.

This process has been designed to keep the customer informed of the progress of both the quotati on and subsequent order, through manufacture and delivery status. Customers will be able to uti lise a secure log in to the site to revisit quotes and view their history. The launch of our new website conti nues our aim of service improvement; we hope customers enjoy using this facility.

Our website can be found at: www.protecx.co.uk

PERFECTEMP™: An Innovati on In Operati ng Table Pati ent WarmingDot Medical Ltd is delighted to introduce the LMA PerfecT-emp™ under pati ent warming matt ress.

Maintaining normothermia in pati ents undergoing opera-ti ons can be a challenge. However the LMA PerfecTemp ™ is a new innovati on off ering warmth beneath the pati ent and advanced pressure reducti on to combat hypothermia and pressure sores.

The LMA PerfecTemp™ pati ent matt ress is

• Lightweight

• Durable

• Quiet

• Delivers controlled and consistent warming

• Has fi bre opti c sensors to measure temperature between the surface of the skin and the pad.

• Easy to clean

• Radio translucent

• Ideal for all operati ons, dialysis units and areas where pati ent warming is imperati ve

For further informati on, contact Dot Medical Ltd: Email: [email protected]: 01625 668811 or Fax: 01625 668855

Siemens introduces new soluti ons at European Cardiology Congress Siemens Healthcare presented its cardiology soluti ons at the Euro-pean Society of Cardiology (ESC) Congress 2010. The innovati ons showcased were designed to provide a higher quality of pati ent care and contribute to reducing costs.

The new 1.5 release of the ACUSON SC2000™ volume imaging ultra-sound system was on show at the Congress, it features a number of innovati ve workfl ow soluti ons and off ers a complete 2D and volu-metric system to improve effi ciency in routi ne echocardiography examinati ons. The recently launched MAGNETOM® Aera 1.5T and Skyra 3T systems were also presented for their ability to reduce the complexity of cardiac MR examinati ons and provide greater image consistency.

The Congress also dedicated special emphasis on the planning of Transcatheter Aorti c Valve Implantati on (TAVI) procedures with the SOMATOM Defi niti on Flash CT and imaging soft ware syngo.via.

Siemens held a number of satellite symposia on the latest cardiology treatments at the ECS Congress that can be viewed at www.siemens.com/esc

Above: New Syngo Aortic ValveGuide imaging software from Siemens Healthcare simplifies workflow for minimally

invasive heart valve implantation.

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We are the fi rst publicati on to be endorsed for CPD by the Soci-ety of Radiographer’s in the UK. We are classed as a varied and topical journal suited to the needs of cardiology radiographers and other practi ti oners in cardiac imaging. May support outcomes 1-14 of CPD Now.

Using the ACIST for TAVI’s at the Harley Street ClinicThe Harley Street Clin-ic recently performed their fi rst TAVI case with Drs Ghada Mikhail and Iqbal Malik. It is thought that this was the fi rst of its type in a private medical insti -tuti on using the ACIST Contrast Management System, which allows for precise and variable fl ows of contrast for both small and larger volumes. Cath Lab Manager Stephen Weymouth said, ‘the whole case went very well and we were pleased that we were able to use the ACIST device for out fi rst TAVI. It made the case quicker as we did not have to set up a separate injector, and safer as it is a closed system so there is less chance of air entering the pati ent’. The Harley Street Clinic is a cardiac centre of excellence which con-ti nues to invest in its experienced consultants, staff and the latest technology. The ACIST provides many advantages for the cardiologist, includ-ing reduced contrast usage and creati ng a safer environment due to radiati on reducti on and its air detectors.

For more informati on, please visit www.apc-cardiovascular.co.uk or call 01270 216142

CoreValve Receives FDA Approval for Evaluati onOn 15th October 2010, Medtronic, Inc. announced U.S. Food and Drug Administrati on (FDA) conditi onal approval for its Investi gati onal Device Exempti on (IDE) applicati on and piv-otal clinical trial protocol to begin evaluati ng the Medtronic CoreValve System for transcatheter aorti c valve implantati on (TAVI). As we featured in the previous editi on of Coronary Heart, the CoreValve system is designed to provide a mini-mally invasive, non-surgical treatment opti on for pati ents


The CoreValve System is not yet commercially available in the US, however since March 2007 when it obtained the CE Mark,


outside the US.



outside the US.

This Product Featured in Edition 26

BARD is our Primary EP Supporter

BARD® EP Fellows CourseBARD® Electrophysiology would like to extend a special thanks to the presenti ng Consultant Electrophysiologists and the att endees, who parti cipated in the BARD® EP Mini Case Review Sessions during the recent Heart Rhythm Congress in Birmingham. The interacti ve sessions, for Cardiology SpR’s or Cardiac Physiologists with at least basic EP knowledge, took place during break ti mes. They proved incredibly popular and were well received by all.

Another EP teaching opportunity occurring soon is a BARD® EP Fellows Course, which takes place during the aft ernoon of 21st November, preceding Europe AF 2010, London. The Deducti ve Electrophysiology course has an Internati onal EP Faculty. Registrati on for the Fellows Course is free, and att endees can also get a special discounted registrati on fee to att end Europe AF 2010. Pre registrati on for the Fellows Course is required.

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TAVI’sMr Vinayak BabatConsultant in Cardiac SurgeryGuys and St Thomas’ Hospital, London, UK

Cardiac Surgeon Interview

When do you think the age criteria will shift so that younger pati ents, who may wish for fem-oral TAVI rather than surgical AVR, can be treated? What about the congenital group?

I think it will take at least 5-10 years before we start using it for younger pati ents. And the rea-son for that is very sim-ple. In younger pati ents’ surgical AVR at present is the gold standard. It is predictable and in younger pati ents the risk is 1-3%. TAVI at present is

only being used in surgically high-risk groups and even here there are compromises. There are issues of positi oning in around 5% of pati ents or 2% in experienced hands. The idea of TAVI’s is to reduce the risk to the pati ents, and unti l we can reduce positi oning risks from 3% to 0% I think we should wait.

The second questi on in relati on to the congenital group is very inter-esti ng. There are two types of congenital pati ents. Firstly and the most common is those with a bicuspid valve. At present you can-not deploy a TAVI without inferior results in this group due to the increased risk of paravalvular leak and coronary occlusion, and it is a contra-indicati on.

But there is another congenital group who have got trileafl et stenosis and I think TAVI might be a bett er opti on here. Kids always grow out of the valve size, so if surgery can be delayed I think there may be an interim applicati on for TAVI in this group.

What is the smallest size femoral sheath that you see being capable of accommodati ng TAVI?

As a surgeon I fi nd this questi on very threatening (laughing), but to be very honest, the Edwards valve used at present is made of bovine pericardium, which is thick, durable and lasts 15-20 years. The thick-ness however takes away the compressibility of the valve and I think the sheath size may get down to 16FR but not more than that.

There is a chance that there will be 2 types of products available in the future, so that you have a valve that is made of porcine valve material or an arti fi cial material like polyurethane; which are thinner but not as durable. But if you know the life expectancy of a parti cu-lar pati ent is less than 10 years, then you could use a thinner valve; that could then be deployed through a smaller sheath. In younger pati ents you would want to use a larger sheath for a more durable valve.

Do you see the costs coming down so that funding by commissioners stops being a problem?

I think that is a very good questi on, because we have now seen the benefi ts in the clinical setti ng, we can look at costs two ways. A tra-diti onal operati on on a sick pati ent incurs greater in-hospital costs which may then exceed the costs of a TAVI. At the same ti me, more competi ti on will drive down prices.

If we treat them either medically or surgically we must look at the total expenditure on the pati ent and include all hospital episodes, all hospital costs. As cost eff ecti veness data becomes available the business case for TAVI will become much stronger.

Also commissioners need to hear the feedback from the community to realize how clinical outcomes, length of stay etc are all improved.

Should all labs undertaking TAVI have (and conti nue to have) vascular surgery on site and available at short noti ce?

In the UK virtually all cardiac surgeons are trained in peripheral vas-cular up to a point, and that’s why the multi -disciplinary approach, which Edwards promotes, has benefi ts. So if you have vascular access problems, there is a surgeon available who has had some vascular training. Having vascular surgeons onsite is an additi onal benefi t but I don’t think it is mandatory in all pati ents to have that back-up all the ti me. If we have any doubts in regards to access problems we discuss it with vascular radiologists and surgeons.

If we think the access site is not suitable for trans-femoral, the beau-ty of the Edwards device is that you can use it trans-apically in the same pati ent. So we don’t push ourselves to limits and take risks that are unnecessary. If your case selecti on is good you will end up with fewer problems.

Interviewed at Edwards Lifesciences’ European Headquarters in Nyon, Switzerland, by Tim Larner, Director of Coronary Heart Publishing Ltd.

Questi ons by Dr Bernard Clarke, Consultant Cardiologist, Manchester Heart Centre

Photography: Tim LarnerValve Image: Courtesy Edwards Lifesciences

Medtronic data on file. Comparison testing to previous delivery catheter system performed in controlled bench top test environment or simulated use testing in anatomical models. Results may not be indicative of clinical performance. U

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LAAOLeft Atrial Appendage Occlusion : A Review

Dr Tim Gatt ornaCardiology fellowRoyal Perth HospitalAustralia

Atrial fi brillati on (AF) is the commonest cardiac arrhythmia with a prevalence of 0.9% in the general populati on, increasing to >13% of people over the age of 80.¹ As our populati on ages,

the prevalence of AF will conti nue to rise with signifi cant clinical and economic implicati ons.2 The most feared and catastrophic complica-ti on of AF is stroke, which is increased fi vefold over an age-matched populati on in sinus rhythm. This is independent of other factors and mostly secondary to thromboembolic events.3

Proven therapies to reduce AF-associated stroke include oral anti co-agulati on with vitamin K antagonists, such as warfarin. However, its narrow therapeuti c window and large number of drug, dietary, and metabolic interacti ons make pati ent response unpredictable and dif-fi cult to manage. This is parti cularly true in older pati ents who are at increased bleeding and stroke risk. Newer pharmacological agents such as the direct thrombin inhibitor, dabigatran, are promising and show similar stroke protecti on to warfarin with less signifi cant bleed-ing.4 Several ongoing studies are examining the potenti al role of new orally acti ve anti -factor X agents.

Given the problems with available pharmacological therapies there has been an impetus for the development of a device-based soluti on for AF-associated stroke. Such strategies have focussed on occlusion of the left atrial appendage (LAA). The reason is that this site is pre-disposed to in-situ thrombus formati on and accounts for the origin of 90% of atrial thrombi in pati ents with non-valvular atrial fi brilla-ti on (NVAF). 5-7The LAA, an embryonic remnant of the original LA, is a multi -lobed, trabeculated structure with considerable anatomical variati on att ached to the LA cavity. In pati ents with AF it has been found to be larger and with greater dysfuncti on, which are mark-ers for increased embolic risk.6, 8-10 Also, previous observati ons have demonstrated that most embolic phenomena were associated with LAA thrombus in pati ents with AF.11,12

Interest in LAA removal or occlusion dates back to the 1930s and can be safely performed during cardiac surgery either with sutures or staples.13 This is most oft en performed during valve surgery or during Maze procedures (the creati on of left atrial lesion patt erns during open heart surgery to eliminate AF), although isolated LAA exclusion via a thoracoscopic approach has been shown to be feasi-ble and safe.14

An alternati ve, less invasive means of LAA exclusion using endo-vascular techniques has been developed. Three diff erent devices

have been used to date: percutaneous LAA transcatheter occlusion (PLAATO) system, the WATCHMAN system and the Amplatzer car-diac plug. These devices are delivered to the LAA following a per-cutaneous femoral transvenous approach and transeptal puncture under fl uoroscopic and transoesophageal echocardiographic (TOE) guidance.

The fi rst of these was the PLAATO system (ev3, Inc., Plymouth, Min-nesota) (Figure 1) consisti ng of a self-expanding niti nol implant cov-ered with an occlusive ePTFE (expanded polytetrafl uoroethylene) membrane.15 Despite initi ally encouraging results in pati ents who had contraindicati ons to warfarin device development was halted for fi nancial considerati ons in December 2006.16,17

The second percutaneous LAA exclusion device is the Watchman Left Atrial Appendage System (Atritech Inc., Plymouth, Minnesota) (Fig-ure 2). The device is a self-expanding niti nol frame structure with fi xati on barbs and a permeable polyester fabric that covers the atrial side.18

The pivotal clinical trial evaluati ng this device was the Embolic Pro-tecti on in Pati ents with Atrial Fibrillati on (PROTECT-AF) trial.19 This was a multi centre, prospecti ve, non-inferiority, unblinded study of pati ents with NVAF who were deemed eligible for warfarin therapy. Pati ents were enrolled in the trial if they had a CHADS2 risk score of 1 or more (ie, at least one of the following: previous stroke or tran-sient ischaemic att ack, congesti ve cardiac failure, diabetes mellitus,

Figure 1: The PLAATO device


hypertension, or were 75 years or older). 707 eligible patients were randomly assigned in a 2:1 ratio to percutane-ous closure of the LAA and short term warfarin (45 days) or to long term warfarin (control group, target international nor-malised ratio 2.0-3.0). Efficacy was assessed by a primary composite endpoint of stroke, car-diovascular death, and systemic embolisation. At 1065 patients-years of follow-up the efficacy of percutaneous closure of the LAA with this device was non-inferior to that of warfarin therapy. The device was successfully

implanted in 91% of those in whom implantation was attempted and 86% of these patients (at 45 days of follow-up) were able to stop taking warfarin; followed by initially 6 months of aspirin and clopi-dogrel after randomisation and then long term aspirin monotherapy. For the control group, a therapeutic INR range (2.0-3.0) was achieved 66% of the time. There was a higher rate of adverse safety events in the interventional group than the control group, predominantly a result of peri-procedural complications such as pericardial effusions. As a result of this trial the WATCHMAN device won the recommen-dations of a US Food and Drug Administration (FDA) advisory panel in April 2009, but is awaiting a further study with more safety and efficacy data before being granted full approval by the FDA.

The third occlusion device, the Amplatzer Cardiac Plug (ACP), is con-structed from a nitinol mesh and Dacron and is currently undergo-ing clinical testing.20-22 It comprises of the lobe, which conforms to the inner structure of the LAA; the waist, which acts as an articulat-ing, compliant connection; and the disc, which covers the LAA ori-fice (see figure 3, Images 1 &2). The device is fully recapturable and repositionable if necessary. Unlike the WATCHMAN device patients do not require warfarin therapy, but rather a short period of dual antiplatelet therapy followed by long term aspirin once successful LAA occlusion has been proven by a follow-up TOE.

AF significantly increases the risk of stroke and providing safe and effective anticoagulant therapy can be challenging. Closure of the LAA provides an alternative strategy of stroke prophylaxis in patients with NVAF. Routine implantation, however, does not appear

warranted, though LAA occlusion may be an option in selected patients with a high risk of bleeding complica-tions from anticoagula-tion. It should be noted that these warfarin-ineligible patients were excluded in the PRO-TECT-AF trial. Further larger, adequately pow-ered studies comparing device deployment to optimal anticoagulation are needed to evaluate

the long term safety and efficacy of such occlusion devices. This is especially true in patients with higher CHADS2 scores or with a previ-ous transient ischemic attack or ischaemic stroke.

References:

1. Phillips SJ, Whisnant JP, O’Fallon WM, Frye RL. Prevalence of cardiovas-cular disease and diabetes mellitus in residents of Rochester, Minne-sota. Mayo Clin Proc 1990;65:344–359.

2. Stewart S, Hart CL, Hole DJ, McMurray JJ. Population prevalence, inci-dence, and predictors of atrial fibrillation in the Renfrew/Paisley study. Heart 2001:86:516-21

3. Wolf PA, Abbott RD, Kannel WB. Atrial fibrillation: a major contributor to stroke: the Framingham study. Arch Intern Med 1987;147:1561-64

4. Connolly SJ, Ezekowiz MD et al. Dabigatran versus Warfarin in Patients with Atrial Fibrillation. NEJM 2009;361(12): 1139-51

5. Blackshear JL, Odell JA. Appendage obliteration to reduce stroke in cardiac surgical patients with atrial fibrillation. Ann Thorac Surg 1996;61:755–759.

6. Wongcharoen W, Tsao HM, Wu MH, et al. Morphologic characteristics of the left atrial appendage, roof, and septum: implications for the ablation of atrial fibrillation. J Cardiovasc Electrophysiol 2006;17:951–956.

7. Stollberger C, Schneider B, Finsterer J. Elimination of the left atrial appendage to prevent stroke or embolism? Anatomic, physiologic, and pathophysiologic considerations. Chest 2003; 124:2356-62

Figure 2: WATCHMAN device

Figure 3: Amplatzer cardiac plug

Image 1: LAA (900 on transoesphageal echocardiogram)

Image 2: Occlusion of the LAA by an Amplatzer cardiac plug (90 degrees on transoesphageal echocardiogram)

continues on page 15


Journals

Heart FailureSHIFT was a randomised comparison of Ivabradine vs. placebo in sys-tolic heart failure pati ents in sinus rhythm, salami sliced into two par-allel arti cles. It att empts to answer the following questi ons: 1. What is the adverse prognosti c impact of elevated heart rate in systolic heart failure pati ents? Answer: 16% increased risk of HF events for every fi ve bpm increase in heart rate; 2. Is the elevated heart rate causal or just a marker of other processes? Answer: Yes, increased baseline heart rate is neutralised by treatment; 3. Is heart rate itself a justi -fi able pharmacological target? Answer: Yes, elevated rates and the benefi t of lowering them remain prevalent, despite prior pharma-cological therapy; 4. Is Ivabradine an eff ecti ve agent in this regard? Answer: Yes, a 5% absolute reducti on of events from 29 to 25% in the ivabradine group at the cost of 4% excess symptomati c bradycardias and 2% visual disturbances. An accompanying editorial welcomes the clarity of data on the impact of heart rate, but expresses cauti on that there may have been inadequate doses of beta blockers in the individuals responding to ivabradine.

Swedberg and others. The Lancet, 2010; 376:9744, 875 – 885.

Böhm and others. The Lancet, 2010; 376:9744, 886 – 894.

Teerlink. The Lancet, 2010; 376:9744, 847 – 84.

It is good, though rare, to see a negati ve trial published in a decent journal. Rolofylline, an adenosine A1-receptor antagonist was test-ed against placebo in 2033 pati ents with acute heart failure and impaired renal functi on. It made no diff erence than placebo to the primary endpoint (treatment success, treatment failure, or no change in the pati ent’s clinical conditi on). Well done to the authors and to the New England Journal of Medicine for publishing it.

Massie and others. NEJM; 2010; 363:1419-28.

Putti ng Lead in Yorkshire PencilsAnother potenti al treatment for use in heart failure and cardiac dis-ease is testosterone. A longitudinal study from a group in Sheffi eld and Barnsley has demonstrated that pati ents with vascular disease and testosterone defi ciency, who were followed up for almost 7 years, had an increased risk of mortality (21%) relati ve to those with normal testosterone levels (12%, p=0.002). Having low testoster-one levels is common - up to 24% depending on the test used in the populati on studied. The obvious next step is a randomised controlled trial of testosterone replacement therapy in high risk pati ents with testosterone defi ciency.

Malkin and others. Heart 2010; 96:1821e1825.

Toys for GeeksCircumferenti al pulmonary vein ablati on has always been an att rac-ti ve target for custom designed catheters. In the last few years we have had at least one catheter available which seems to be safe and eff ecti ve (PVAC), although concerns have been that it ablates further onto the venous side of the atrium than ideally placed point by point lesions. We now have the fi rst of a series of randomised comparisons; 102 pati ents with paroxysmal atrial fi brillati on were randomised to either mapping, guided point by point, or PVAC pulmonary vein isola-ti on. Procedure and screening ti mes were signifi cantly shorter in the PVAC group, whilst fi rst procedure success rates were comparable in the PVAC and conventi onal arms (77 vs. 71% over a short follow up of 6 months). The PVAC was noted to be unsuited to single common left sided atria.

Alan Bulava and others. PACE 2010; 33:1039–1046.

Ablati on of typical atrial fl utt er is now regarded as standard fi rst line therapy and highly successful. In an att empt to improve on this already highly effi cient procedure, a multi electrode catheter (TVAC) from the same stable as the PVAC was used to ablate the cavotri-cuspid isthmus in a randomised comparison with 8mm ti p catheter ablati on. Thirty pati ents in each group underwent ablati on with sig-nifi cantly shorter radio frequency (8.5 vs. 14.7 min) and procedure ti mes (40.2 vs. 60.5 min) in the TVAC group. There was one failure to achieve block in the TVAC group and two late recurrences in each group.

Ali Erdogan and others. J Cardiovasc Electrophysiol. 2010; 21:1109-1113.

Resuscitati onIt used to be said it was impossible to conduct meaningful compari-sons of resuscitati on techniques, due the ethical diffi culti es involved. This has now been thoroughly disproved by the number of studies recently published on the subject and with yet another compari-son of chest compression only vs. classically taught CPR, it is almost becoming boring.

In a comparison of classical CPR vs. chest compressions only vs. no CPR, provided by non-medical bystanders in over 5000 pati ents, sur-vival to hospital discharge was signifi cantly improved by chest com-pressions only (13.3%) when compared to both classical CPR (7.8%) and no CPR (5.2%). In fact, aft er appropriate adjustment, classical CPR may off er no survival benefi t against no CPR.




This is concordant with other studies we have previously reported, and explanati ons for these fi nding may include; technical diffi culty in delivering eff ecti ve respiratory support, interference of arti fi cial respirati on with delivery of CPR, bystanders being put off by arti fi cial respirati on and effi cacy of chest compressions in venti lati on.

Bobrow and others. JAMA. 2010; 304(13):1447-1454. Coronary Interventi onBare metal stents (BMS) have a signifi cant incidence of resteno-sis and were largely superseded by drug eluti ng stents (DES) that became available in 2002. There was then global concern regarding the risk of stent thrombosis in pati ents with fi rst generati on DES, fol-lowing presentati ons of two meta-analyses at the ESC in Barcelona, in 2006. There was a subsequent reducti on in the use of DES and numerous further studies have been published that have been, on the whole, reassuring. As a result, nati onal guidelines recommended dual anti platelet therapy for a minimum of 12 months in all pati ents receiving DES.

A recent prospecti ve, multi center, Spanish registry of 4,768 ‘real world’ pati ents demonstrated a cumulati ve incidence of defi nite/probable thrombosis for zotarolimus eluti ng stents (ZES – Endeavor / Medtronic) of 1.3% at 1 year and 1.7% at 2 years, and for everolimus eluti ng stents (EES - Xience / Abbott or Promus / Boston) of 1.4% at 1 year and 1.7% at 2 years (p = 0.8 for ZES vs. EES). These fi gures are reassuringly lower than with the fi rst generati on DES, but sti ll emphasise the importance of good stent deployment and adequate dual anti platelet therapy. Interesti ngly, in the subset of pati ents with bifurcati on lesions, ZES signifi cantly increased the risk of stent thrombosis compared to EES. Of course, there are now third genera-ti on, biodegradable polymer, nitric oxide producing and endothelial progenitor capture cell-coated stents available as well.

De la Torre Hernandez and others. JACC Cardiol. Intv. 2010;3;911-19.

Another trial has been reported comparing percutaneous coronary interventi on (PCI) and surgical revascularisati on (CABG) for multi ves-sel disease, but this ti me in pati ents with acute coronary syndromes (ACS). The ACUITY trial was originally designed to compare 3 diff er-ent anti thromboti c regimens in moderate to high risk ACS pati ents (unfracti onated heparin or low molecular weight heparin with a gly-coprotein (GP) IIbIIIa inhibitor, bivalirudin with a GPIIbIIIa inhibitor, or bivalirudin alone). Of the 13,819 pati ents enrolled, 56% (7,789) underwent PCI and 11% (1,539) had CABG. The remaining 33% were treated medically, at the investi gators discreti on. Aft er propensity matching (the latest trendy stati sti cal method to correct for varia-bles) pati ents treated with PCI had lower rates of stroke, myocardial infarcti on, major bleeding, and renal injury than those treated with CABG, with comparable 1-month and 1-year rates of mortality, but more oft en developed recurrent ischemia requiring repeat revascu-larizati on procedures during follow-up.

Ben-Gal and others. JACC Cardiol. Intv.;3:1059-67.

A registry comparing PCI and CABG in left main stem disease has also been reported this month. The ASAN-MAIN (Asan Medical Center-Left Main Revascularizati on) study published 10-year data on 350 pati ents with unprotected left main disease who were treated with either CABG or BMS, and fi ve-year data on 395 pati ents treated with either surgery or a DES (mainly sirolimus eluti ng Cypher stents). Aft er adjustment for variables, results were equivalent between the two methods of revascularisati on, in terms of mortality and a combined end point of death, Q-wave MI, or stroke. However, as with other studies (SYNTAX and COMPARE-MAIN), both BMS and DES pati ents were more likely to require further revascularisati on during follow up. In Europe, as part of the newest European Society of Cardiology guidelines, coronary stenti ng of left main disease is a class IIa, level of evidence B, recommendati on.

Park and others. JACC;56:1366-1375.

References (cont...)

8. Agmon Y, Khandheria BK, Genti le F, Seward JB. Echocardiograph-ic assessment of the left atrial appendage. J Am Coll Cardiol 1999;34:1867–1877.

9. Predictors of thromboembolism in atrial fi brillati on: II. Echocar-diographic features of pati ents at risk. The Stroke Preventi on in Atrial Fibrillati on Investi gators. Ann Intern Med 1992;116:6–12.

10. Transesophageal echocardiographic correlates of thromboem-bolism in high-risk pati ents with nonvalvular atrial fi brillati on. The Stroke Preventi on in Atrial Fibrillati on Investi gators Commit-tee on Echocardiography. Ann Intern Med 1998;128:639–647.

11. Garcia-Fernandez MA, Perez-David E, Quiles J, et al. Role of left atrial appendage obliterati on in stroke reducti on in pati ents with mitral valve prosthesis: A transesophageal echocardiographic study. J Am Coll Cardiol 2003;42:1253–1258.

12. Belcher JR, Somerville W. Systemic embolism and left auric-ular thrombosis in relati on to mitral valvotomy. Br Med J 1955;2:1000–1003.

13. Healey JS, Crystal E, Lamy A, et al. Left Atrial Appendage Occlusion Study (LAAOS): Results of a randomized controlled pilot study of left atrial appendage occlusion during coronary bypass surgery in pati ents at risk for stroke. Am Heart J 2005;150:288–293.

14. Johnson WD, Ganjoo AK, Stone CD, et al. The left atrial append-age: Our most lethal human att achment! Surgical implicati ons. Eur J Cardiothorac Surg 2000;17:718–22.

15. Sievert H, Lesh MD, Trepels T, et al. Percutaneous left atrial appendage transcatheter occlusion to prevent stroke in high-risk pati ents with atrial fi brillati on: Early clinical experience. Circula-ti on 2002;105:1887–1889.

16. 16. Ostermayer SH, Reisman M, Kramer PH, et al. Percutaneous left atrial appendage transcatheter occlusion (PLAATO system) to prevent stroke in high-risk pati ents with non-rheumati c atrial fi brillati on: Results from the internati onal multi -center feasibil-ity trials. J Am Coll Cardiol 2005;46:9–14.

17. 17.Bayard YL, Omran H, Neuzil P, Thuesen L, Pichler M, Rowland E, Ramondo A, Ruzyllo W, Budts W, Montalescot G, Brugada P, Ser-ruys PW, Vahanian A, Piéchaud JF, Bartorelli A, Marco J, Probst P, Kuck KH, Ostermayer SH, Büscheck F, Fischer E, Leetz M, Sievert H. PLAATO (Percutaneous Left Atrial Appendage Transcatheter Occlusion) for preventi on of cardioembolic stroke in non-anti -coagulati on eligible atrial fi brillati on pati ents: results from the European PLAATO study. EuroInterventi on. 2010;6:220-6.

18. 18. Sick PB, Schuler G, Hauptmann KE, et al. Initi al worldwide experience with the WATCHMAN left atrial appendage system for stroke preventi on in atrial fi brillati on. J Am Coll Cardiol 2007;49:1490–1495.

19. 19. Holmes DR, Reddy VY, Turi ZG, Doshi SK, Sievert H, Buchbind-er M, Mullin CM, Sick P; PROTECT AF Investi gators. Percutane-ous closure of the left atrial appendage versus warfarin therapy for preventi on of stroke in pati ents with atrial fi brillati on: a ran-domised non-inferiority trial. Lancet. 2009; 374:534-4.

20. 20. Park JW, Bethencour A, Sievert H, Santoro G, Meier B, Walsh K,. Lopez-Minquez JR, Meerkin D, Ormerod O, Leithäuser B. Left atrial appendage closure with Amplatzer cardiac plug for preven-ti on of stroke in atrial fi brillati on – initi al European Experience. Eur. Heart J. 2010;12(suppl A):S14

21. 21. Rodés-Cabau J, Champagne J, Bernier M. Transcatheter closure of the left atrial appendage: initi al experience with the Amplatzer cardiac plug device. Catheter Cardiovasc Interv. 2010;76: 86-92.

22. 22. Bass JL. Transcatheter occlusion of the left atrial appendage--experimental testi ng of a new Amplatzer device. Catheter Car-diovasc Interv. 2010; 76:181-5.

.....conti nued from page 13


PharmaCardiology

Atrial Fibrillati on (AF) is characterised by uncoordinated atrial acti vity with consequent deteriorati on of atrial mechanical functi on. AF is the most common arrhythmia and responsible

for many hospital admissions. This is due to the aging populati on and an increase in heart disease. There are three main objecti ves for the management of pati ents with AF: rate control, preventi on of thromboembolism, and correcti on of the rhythm disturbance.

Dronedarone marketed as Multaq by Sanofi -Aventi s is licensed for clinically stable adult pati ents with a history of, or current non-per-manent atrial fi brillati on (AF) to prevent recurrence of AF or to lower ventricular rate. Dronedarone belongs to the benzofuran class of anti arrhythmic drugs and is contraindicated in unstable pati ents with NYHA class III and IV heart failure. Its use is also not recommended in stable pati ents with NYHA class III heart failure or with left ven-tricular ejecti on fracti on less than 35%.

NICE Guidance using the single technology appraisal process was published in August 2010 (www.nice.org.uk/TA197) and this paper aims to give a summary of the main points.

NICE Clinical Guideline 36 in 2006 (management of AF) states that Beta blockers in additi on to anti coagulati on should be the initi al treatment opti on for people with symptomati c paroxysmal atrial fi brillati on and people with persistent atrial fi brillati on in whom an anti arrhythmic drug is needed to maintain sinus rhythm aft er cardio-version. Amiodarone, sotalol or a class 1c drug should be used as a second line treatment opti on if standard beta blockers are contrain-dicated or fail to improve symptoms.

Amiodarone was noted to be an eff ecti ve anti arrhythmic drug for controlling AF but due to high level of toxicity many people were not able to tolerate it. There were also many pati ents who could not tolerate a 1c anti arrhythmic agent or sotalol who may benefi t from

dronedarone instead with a more favourable side eff ect profi le in some pati ents. The guide recommends initi ati on of dronedarone under the supervision of a specialist in secondary care setti ng.

Clinical informati on on dosage & administrati on

Treatment with dronedarone is initi ated at 400mg twice a day in adults with a morning and evening meal. If the pati ent is already

NICE Appraisal on Dronedarone for the treatment of non-permanent Atrial Fibrillati on (AF)

Dr Mojgan Sani, DPharm, MBA, MRPharmS

Head of Clinical Pharmacy, Royal Berkshire Foundati on Trust & Nati onal non-medical prescribing Facilitator, Nati onal Prescribing Centre.

Dronedarone is recommended in pati ents with non-permanent AF only in people:

◊ Whose AF is not controlled by fi rst-line therapy (usually including beta blockers), that is, as a second line opti on,

and

◊ Who have at least one of the following cardiovascular risk factors:

› hypertension requiring drugs of at least two diff erent classes

› diabetes mellitus › previous transient ischaemic att ack, stroke or systemic embolism

› left atrial diameter of 50mm or greater › left ventricular ejecti on fracti on less than 40% or › age 70 years or older,

and

◊ Who do not have unstable NYHA class III or IV heart failure.

NICE Guidance recommendation for use of Dronedarone


PHA

RMA

on any class 1 or 3 antiarrhythmics, this should be stopped before starting dronedarone. No dose adjustment is necessary in the elderly population with renal impairement (except contraindication in severe renal impairement of creatinine clearance of less than 30 ml/min). No dose adjustment is necessary in patients with mild to moderate hepatic impairement but contraindicated in severe hepatic failure.

The dose should not be taken with grapefruit juice as it increases dronedarone exposure. Doses of digoxin should be reduced by 50% if concurrently used with dronedarone. There are a number of other clinical drugs interactions. Pharmacists should refer to the SPC to ensure safety of polypharmacy when they have a patient on dronedarone.

The most frequent adverse effects include an elevated blood cre-atinine level and prolongation of QT interval. Other common adverse events may include diarrhoea, nausea, vomiting, fatigue and asthenia.

Clinical effectiveness from trials

The four main clinical trials (ATHENA, EURIDID, ADONIS and DIO-NYSOS) demonstrated the superior efficacy of dronedarone over placebo but also showed less efficacy against amiodarone and other antiarrhythmic agents.

EURIDIS (EURopean trial In atrial fibrillation patients receiving Dronedarone for the maIntenance of Sinus rhythm) and ADONIS (American-Australian-African trial with DronedaONe In atrial fibril-lation patients for the maintenance of Sinus rhythm) were phase III multicentre, parallel, randomised double blind, placebo-controlled trials of the same design and were reported together. A total of 612 patients were recruited into the EURIDIS trial and 625 patients into the ADONIS trial. Both dronedarone and placebo were given in addi-tion to standard first-line therapy of beta blocker and anticoagula-tion. Patients had paroxysmal or persistent atrial fibrillation or atrial flutter. The primary endpoint was the first documented recurrence of AF lasting at least 10 minutes. Secondary endpoints included symptoms related to AF during recordings and mean ventricular rate during first recurrence. The results showed that fewer people in the dronedarone arm had AF recurrence at 12 months than pla-cebo (p<0.001). These trials also reported a lower ventricular rate in the dronedarone compared to placebo.1 Symptomatic recurrence occurred in 37.1% and 47.5% of patients treated with dronedarone or placebo respectively (p=0.006).

ATHENA was also a phase III multicentre, parallel, randomised, dou-ble blind placebo controlled trial of 4,628 patients. Both dronedar-one and placebo were given in addition to standard first-line therapy of beta blocker and anticoagulation. Patients had paroxysmal or persistent atrial fibrillation or atrial flutter with at least one of the following additional risk factors for a major cardiovascular event. The primary endpoint was first hospitalisation due to cardiovascu-lar events or death from any cause.2 A total of 31.9% of patients in

the dronedarone group experienced the primary outcome compared to 39.4% in the placebo group (p<0.001). The results were driven by a lower hospitalisation rate in the dronedarone group compared to placebo. This trial reported lower cardiovascular mortality in the dronedarone group compared with placebo but no statistically sig-nificant difference in all cause mortality.2,3

DYONYSOS was a phase III randomised double blind trial of 504 patients, comparing dronedarone with amiodarone. Patients had paroxysmal or persistent atrial fibrillation or atrial flutter in whom cardioversion and antiarrhythmic treatment were indicated plus anticoagulation. The primary endpoint was treatment failure as defined by recurrence of AF or premature study drug discontinuation for intolerance or lack of efficacy. The primary endpoint occurred in 73.9% of patients treated with dronedarone compared to 55.3% for amiodarone (p<0.001). The absolute difference in primary endpoint between dronedarone and amiodarone was 18.5%. AF recurred in 36.5% in the dronerdarone compared to 24.3% in the amiodarone group. The trial reported fewer deaths in the dronedarone group compared to amiodarone, but NICE has drawn no conclusion about the relative effect of dronedarone and amiodarone on mortality due to short follow up of the trial and the small number of deaths in the study.4

NICE Audit support

NICE has also made available an audit tool (www.nice.org.uk/TA197) in order to support measuring current practice in using dronedarone for the treatment of non-permanent AF against the recommenda-tions made. The standards set against the guidelines are 100% com-licance but NICE recommends that the standards can be flexible and need local discussions with the specialist clinicians.

References1. Singh BN, Connolly SJ, Crijns HJ, et al. Dronedarone for maintenance

of sinus rhythm in atrial fibrillation or flutter. N Engl J Med 2007; 357: 987-999.

2. Hohnloser SH, Crijns HJ, van Eickels M, et al. ATHENA Investigators. Effect of dronedarone on cardiovascular events in atrial fibrillation. N Engl J Med 2009; 360: 668-678.

3. Hohnloser SH, Crijns HJ, van Eickels M, et al. ATHENA Investigators. Dronedarone in patients with congestive heart failure: Insights from ATHENA. European Heart J July 2010; 31 (14): 1717-21

4. Letteuzey JY, De Ferrari GM, Radzik D, et al. DIONYSOS Investigators. A short term, randomised, double blind, parallel group study to evaluate the efficacy and safety of dronedarone versus amiodarone in patients with persistent atrial fibrillation. Journal Cardiovasc Electrophysiol, June 2010; 21 (6): 597-605.


Clinical Background

This ECG was recorded in at 10mm/mV and 25mm/sec.

Questi ons1. What underlying channelopathy is evident on this

ECG?

2. Explain the arrhythmic issues associated with this syndrome.

3. What is the inherited geneti c mutati on associated with this disorder?

Answer on Page: 27



ChallengeSophie Blackman’s ECG

Love our ECG Challenges?

We have 18 ECG Challenges on our website just waiti ng for you to solve, all of which have been featured in this publicati on over the years.

By popular demand, starti ng in 2011 we will be adding a bonus ECG Challenge online only, for those unable to wait a couple of months between editi ons. Lucky you!!

CardiologyHD.com


Management: Three Top TipsMs Sophie BlackmanCoronary Heart Management and CRM Consulti ng Editor

Head of Clinical Cardiac PhysiologyWest Hertf ordshire NHS Trust

The last few management arti cles I have writt en were directed at managers. This week I have my top 3 ti ps for the non-managerial staff members out there. These ti ps should give you insight that can help your manager out and in turn result in a positi ve working experience for you.

Remember this: A manager knows who turns up late, and who is lazy, who works hard to escape their emoti onal distress, who is a moti vator, who is working hard and who isn’t. I once worked with someone who would tell me every day every-thing they had done at work. I used to sit there thinking – yes that is your job, why are you telling me this? Don’t boast to your manager about your workload unless you have gone above and beyond your job descripti on.

If you are the one who goes to the manager to complain about other staff members work and to let your manager know how very hard you work comparati vely, then you are the one your manager is keep-ing an eye on. The ti me you spend looking at and complaining about what everyone else is doing (or not doing) is ti me you are not getti ng on with your own work – why adverti se the fact?

Soluti on: Help your manager by encouraging those around you in a way that moti vates them. Be the moti vator in your team and your manager will know it. They will thank you for helping rather than having to endure you complaining every day which they don’t have ti me for.

Remember this: A manager will be grateful if you bring them soluti ons not problems.

It is easy when a problem emerges to take it straight to your man-ager. ‘I can’t be expected to do this….’ ‘There isn’t enough ti me….’ ‘No I can’t’. These common statements we hear from staff do not help nor impress.

Soluti on: Tell your manager what changes can be made so the prob-lem doesn’t keep occurring. ‘I’ve noti ced X keeps happening, and I thought it would be a good soluti on if we perhaps did XYZ to make things easier…’ This is one part of the service the manager will now not need to review, it shows you have initi ati ve and some managerial qualiti es and this impresses your manager and also improves your working environment by getti ng rid of the problems.

Remember this: You don’t need to understand your manager’s role completely, but no matt er how good or bad you perceive your manager to be, rest assured they are busier, more stressed and hold more responsibility than you realise. Most managers, even if you do see outward signs of pressure upon them, keep the majority of their stresses and responsibiliti es from you.

Every piece of work that a member of your department does ulti -mately rests in the hands of your manager. They have to be the one accountable for errors, mistakes, complaints. Everything that you do as a worker directly aff ects your manager. It either makes their day easier or harder – and this is the very simple piece of informati on you must remember in order to learn how to get what you want from your manager.

Soluti on: In the simplest of terms, if you use your ti me to ensure that your managers’ workload is not increased by the somewhat simple yet ti me consuming complicati ons of the working day – then you can help your manager to achieve their targets. Work hard, work accurately and work well. Help those around you and be encouraging of good practi ce.

* * *

A manager in a busy cardiac department has a job that is varied and unpredictable. There is always something that they have to be concentrati ng on, a pressure from above, or a target they have to achieve. If you can work in a way that supports your manager with some of the more simple tasks then you help them to focus on the part of their job that is more concentrated on your team and the work you do, allowing them to be a bett er manager to you. As a man-ager my favourite words to hear are ‘Is there anything I can help you out with?’ I am sure your manager will not mind hearing it once in a while either.

AssistanceManagement

Give your manager time to do their work

Provide solutions

Remember this:

A manager knows1

2

3


Site VisitUnited Kingdom

Completed with the assistance of Volcano

Raigmore Hospital is located in Inverness, a rapidly growing city in northern Scotland. Located 254km north of Edinburgh, and 903km north of London, the city is situated at the mouth of the River Ness, which fl ows from the nearby Loch Ness. The populati on is approximately 57,000, with two languages spoken, being English and Scotti sh Gaelic, and is ranked fi ft h out of 189 Briti sh citi es for quality of life.

What are the sizes of your Cardiology Department and Hospital?

Raigmore Hospital is the 600 bedded regional centre for the High-lands of Scotland. Within the Cardiac Unit there is a 6 bedded CCU and 16 bedded step down ward. There is also a dedicated cardiac rehab unit. (The Highland Heartbeat Centre)

What is the geographical intake area and populati on served by your hospital?

NHS Highland covers 41% of the land mass of Scotland, same size as Wales! 300,000 people live in the area but there is a large tourist infl ux. The dispersed populati on makes this one of the least densely populated areas in Europe with some of the most remote pati ents and many island communiti es.

How many staff ? Roles?

We have recently expanded to 4 consultants (2 PCI trained) as well as a fully staff ed CCU, Cath Lab and Cardiac Investi gati ons unit. Cardiac rehab teams are present throughout the area and there are good links with our local district and community hospitals. Types of procedures?

Other than EP, there is a full range of cardiac services available including diagnosti c angiograms, PCI, bradycardiac pacing, ICD, TTE, TOE, cardiac CT, cardiac MRI, and MPS. Types of equipment used?

The current lab used is a Philips modular lab but in March 2011 our new lab complex will be opened with GE cath labs, integrated Vol-cano for IVUS and pressure wire.

Raigmore HospitalRaigmore HospitalOld Perth RoadInvernessIV2 3UJUnited Kingdom

RaigmoreHospital


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How do you believe the integrated Volcano Multi-modality system will benefit your new Catheter Lab?

The Volcano integrated system provides a unified platform includ-ing FFR and IVUS and is integrated with the DICOM System, meaning that all our FFR & IVUS reports are consolidated with the angiograms. This integration assists our Cath Lab Staff as it ensures the workflow in the lab is much smoother and importantly time saving, without the need to bring in different pieces of kit for each procedure. The other advantage means they only need to be trained on one system for all modalities. Having this integrated system will also allow us to take advantage of the future technologies that Volcano are currently developing, including Forward Looking IVUS (FLIVUS) & OCT.

How many procedures are performed a year?

Our lab is projected to undertake approximately 1000 angiograms this year. Over 150 PCI’s were performed in the first 4 months since starting PCI in May 2010, thus we predict we will undertake around 350 in the first year. IVUS and pressure wire are important tools – we performed 19 IVUS and 7 pressure wire studies in the first few months. What is the approximate percentage of cath lab cases performed radially compared with femorally?

85 percent are radial. Does your department offer a Primary Angioplasty Service? If yes, what have been some of the challenges setting it up? If not, is this planned for the future?

Due to the dispersed nature of our population and the presence of only 2 PCI cardiologists, the development of a PPCI service will be a challenge for the cath lab and the ambulance service. Currently we operate a mandated ECG telemetry service to the ambulance ser-vice - where ECGs are telemetered for prehospital thrombolysis. At

present over 90% receive thrombolysis. Overall our PHT rate is 60%. Discussions are under way to offer PPCI to the 60% of the population who live within 1 hour drive time of the lab. Are any of your staff cross-trained (generic workers)? Future?

No, but this is something we are actively looking at to overcome the smaller number of staff in each discipline. This should allows us greater flexibility when opening the lab out of hours.

What new procedures / techniques have you implemented into the department recently? Future?

PCI has been the main focus this year but we have been lucky to attract an established consultant (Peter Clarkson) who is proficient in CRT, and we hope to start this service soon.

What are the benefits to patients attending your facility?

The development of on-site PCI has had an enormous benefit to patients. While we have not developed a PPCI service yet, several patients have had rescue or primary PCI within the cath lab operating times. The treatment of NSTEMI patients has been greatly improved and the turn-over of patients on our cardiac step down ward has quadrupled since the start of the PCI service.

How is your inventory managed?

Stock at present is a paper system with Excel spread sheet support, and a dedicated store person. We are looking into costing and imple-menting a bar code system that will have set levels, max/min, and can re-order with a link to automatic ordering when these levels are at a minimum.

Cath Lab Staff (from left): Dr Jamie Smith, Isobel Adams (Cath Lab Manager), Prof Steve Leslie, Karen Hercher (Cath Lab Nurse), Morag Nicoll (Radiographer),

and Margaret-Ann Martin (Physiologist)


How does the lab handle haemostasis?

As the majority of our cases are radial the TR band is our main meth-od. For those pati ent requiring femoral puncture we use either angi-oseal or exoseal depending on the pati ent situati on.

What measures has the department implemented to cut costs?

We are conti nually seeking for competi ti vely price products. Further-more approximately 50% of our PCI cases will be undertaken as day case procedures and this has a cost saving.

What kind of training can new employees expect to receive?

Staff new to the cardiology DCU/Cath Lab can expect to be supernu-mery initi ally and have an appointed member of staff as their mentor to support them in the early stages of learning. They assist with new procedures, guidelines and protocols for the safe delivery of high standards of care. A training pack is given to each member of staff covering anatomy and physiology of the heart plus cardiac interven-ti ons, angiograms, pacing, PCI, ETT, MPS and cardiac rehab. Once familiarised with daycase procedures, and protocols, staff are inte-grated into cath lab working, observing initi ally, followed by scrub-bing in with a senior member of staff . Consultant input in the cath lab also contributes in training staff as scrub nurses, parti cularly as second operators for PCI, with cath lab manager support.

What kinds of conti nuing educati on programs are available to staff ?

We are fortunate at Raigmore to have Charlie Bloe from CB train-ing as our CCU ward manager. Training programs for nurses include, online educati on programmes for ACS, drug calculati ons, IABP, ECG recogniti on and thrombolysis training days. We have an annual con-ference, Heart of the Matt er which is well att ended by those inter-ested in cardiac care in the Highlands. Isobel Adams, our cath lab sister joined us this year and brings great experience from James Cook Hospital in Middlesbrough, which has been extremely valuable when setti ng up the service.

What kinds of competency checks do staff have to undergo once employed?

Competencies for staff have been developed and implemented as a means to assess the knowledge gained by staff during training, where extra support is needed, and to deem a member competent in a parti cular area. For example, the following are assessed by the cath lab manager/clinical educator: pati ent safety and risk, through check lists, orientati on (to know where equipment is and what it’s for), procedures, theoreti cal and practi cal knowledge. A new com-petency being developed is a log for staff covering scrub and second operator in the cath lab, fl ooring (scout nursing), and FFR/IVUS. This will be assessed every 3 months.

How do you deal with late fi nishing of cases?

Currently PCI is limited to morning working only – however as pre-dicted this is insuffi cient capacity, and discussions are ongoing to cre-ate an oncall staff to allow PCI in the aft ernoons.

What is your policy for company reps within the labs?

Reps are encouraged to visit BUT in line with BCIS recommendati ons are only allowed in the lab when specifi c staff training is required.

Reducing radiati on dose is a high priority in the cath labs. What techniques are employed by your radiographers to ensure dosage during cases is kept to a minimum? Also what is the maximum dose limit a pati ent can receive in your labs before it is recorded in their notes, and what is the follow-up process?

Slick PCI operators is clearly the key to reducing radiati on dose! Low dose screening and aquisiti on techniques are used with low screening and aquisiti on ti mes, and collimati on where possible.

We also ensure we use appropriately trained specialist radiographers. All staff must wear correct lead equivalent personal protecti on and radiati on monitoring badges. Use of lead shielding on equipment and the numbers of staff in the lab are kept to a minimum when using radati on. Radiographers noti fy cardiologists when skin dose is 2 Grays (200 DGS). Cardiologists consider staged procedures or where possible change the angle of the tube. The medical physics depart-ment is informed when a high dose occurs, and the Cardiologist is responsible for the medical follow up.

What are the advantages for SpR’s training at your facility?

We provide a truly consultant delivered service (due to lack of SpRs) thus a trainee at Raigmore will be ensured of excellent supervision during their training and exposure to a range of cardiac pati ents.

What is the best part of working at your facility?

The team eff ort to establish PCI has been a great bonding experi-ence. The enthusiasm and skills of the cath lab staff have been par-ti cularly uplift ing, and the transformati on of the pati ent fl ow in the CCU and cardiology ward has only been achievable due to the huge eff ort of the nurses and support staff in these areas.

CardiologyHD.comSee our other Site Visits online today:

• The London Independent Hospital

• St Bartholomew’s Hospital (Barts)

• Hammersmith Hospital

• Kings College Hospital

• Guy’s & St Thomas’ NHS Foundati on Trust

• The Wellington Hospital

• Northampton General Hospital

• West Hertf ordshire Hospitals NHS Trust

• Essex Cardiothoracic Centre

• Freeman Hospital

• The Liverpool Heart and Chest Hospital

• Manchester Royal Infi rmary

• Southampton General Hospital

• East Surrey Hospital

• Royal Bournemouth Hospital

• Royal Cornwall Hospital

• Princess of Wales Hospital

• Waterford Regional Hospital (Ireland)

• Christchurch Hospital (New Zealand)

Plus many more from Australia, New Zealand, and the USA.


Charlie Bloe: Senior Nurse NHS Highlands

Where did you train?

I undertook the BSc Social Sciences and Nurs-ing Studies at the University of Edinburgh between 1979 and 1984. At that ti me it was also possible to undertake the Nati onal District Nursing Certi fi cate so I completed that training before job hunti ng. My Criti cal Care qualifi ca-ti ons were obtained at the Western Infi rmary school of Nursing in Glasgow.

Why did you decide to specialise in Cardiology?

It was almost by default! I had att ended an interview at Forth Valley Acute Hospitals for a job as staff nurse in a general medical ward. At a pre interview visit the Nursing Offi cer, Greta Given, showed me the Medical HDU and combined CCU facility where a vacancy also existed. I was off ered both opti ons and opted for the CCU role. I guess that I therefore owe my career in Cardiology to Greta, who has sadly since passed away.

You spent many years away from clinical practi ce to set up your own successful business, Charles Bloe Training. What brought you back to clinical practi ce and what is your current role?

I’ve always had a passion for teaching but preferred the fl exibility of undertaking ad hoc freelance consultancy work as opposed to a Uni-versity based post. I established Charles Bloe Training 13 years ago and it quickly became very successful. We deservedly developed a reputati on for providing quality clinical updates for nurses and over a period of ti me I recruited over 30 freelance consultants to deliver the training across the UK and beyond. I also had aspirati ons to explore the feasibility of web based training and have subsequently devel-oped a portf olio of 30 online clinical courses. The ECG in Acute Coro-nary Syndrome course was awarded fi rst place at the Briti sh Journal of Cardiac Nursing awards in 2008 for Innovati on in Educati on. With so much to do I decided to leave clinical practi ce in 2000 to focus on the training business full ti me.

During that period I relocated to the Scotti sh Highlands and in 2008 I happened to meet Prof. Steve Leslie who I had previously worked with at Falkirk Royal Infi rmary. He informed me of the vacant Clinical Ward Manager post at Raigmore Hospital’s CCU facility. Although it was not my intenti on to return to the ‘sharp end’ of cardiac care I was excited by the challenges that Steve highlighted and the vision he had for the service. So here I am!

I’ve only been in post for a litt le over 2 years and it has been a great move. I have a fantasti c group of staff who have demonstrated a tre-mendous desire to further develop their roles and we’ve made enor-mous strides in my ti me here. The staff have been a real credit to me and to themselves.

I believe that the service we provide for cardiac pati ents in NHS Highland is very personalised. We have established a good number of nurse-led initi ati ves such as rapid access chest pain and have uti -lised telemedicine to dramati cally improve pre hospital reperfusion with thrombolysis. ECG’s are transmitt ed from pati ent’s homes, that can be in excess of 2-3 hours away, to the CCU and this has resulted in most eligible pati ents receiving pre hospital thrombolysis. I was delighted when the nurses and Paramedics of NHS Highlands won an award in the ‘Changing for the Bett er’ category at this years staff awards for their achievements in this area.

InterviewCardiac Nursing


Charlie Bloe (pictured on the right) receives “Innovation through Education” award at the Cardiac Nursing awards in 2008


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We have a fi rst class cardiac rehabilitati on service located within the purpose built Highland Heartbeat Centre. Add in nurse-led services in electi ve cardioversion, ICD support and pre and post coronary angiography and we have what we believe is a mini centre of excel-lence serving a much dispersed populati on.

I have also taken on the role of Clinical Lead for the cardiac MCN. We are so dependent on our primary care colleagues to deliver pre hospital cardiac care and this post helps me understand the issues in primary care and foster closer links with the GP’s and Paramedics on who we depend so much. How has the world of cardiology nursing changed since you were away?

Had I not been involved in providing clinical updates I suspect that the changes would have seemed dramati c in the 8 years I was away from clinical practi ce.

The most obvious change in coronary care in the last decade or so has been the emergence of PCI as the preferred reperfusion strategy in STEMI pati ents.

There has also been a welcome increase in nurse-led initi ati ves and a greater acceptance of this support by our medical colleagues. It is reassuring that we now seldom read publicati ons directly comparing the clinical abiliti es of nurses versus doctors. That wasn’t the case 10 years ago.

It has taken some ti me but the emergence of telemedicine has allowed collaborati ve decision-making between paramedics and CCU nurses based on 12-lead ECG telemetry that expedites the delivery of pre hospital thrombolysis in STEMI. It is important that cardiac nursing embraces new technologies and this is a prime example of that. We’ve been tremendously successful in improving pre hospital thrombolysis delivery by paramedics and GP’s uti lising this technol-ogy coupled with nursing support. It has increased from approx. 20% to over 75% in the last year.

You must have the catheter lab which is the furthest north in the UK. What are the challenges of having a cardiology centre which is based so remotely and how have you and your colleagues in Raigmore dealt with these challenges?

Yes that is a major issue. We have a populati on of litt le over 250,000 but they are dispersed over a geographical area that’s bigger than Belgium! Add in remote country roads and prett y harsh winter weather and you begin to understand the challenges in providing acute cardiac care in NHS Highland.

We have two interventi onal cardiologists in Prof. Steve Leslie and Dr. Jamie Smith. We’ve had a diagnosti c angio service for some years and commenced PCI in May 2010. However with our relati vely small populati on and limited interventi onal capacity we have to take a

pragmati c approach to opti mal reperfusion for STEMI pati ents. Given the long transportati on ti mes it is likely that coronary throm-bolysis will remain our primary reperfusion strategy and that makes the collaborati on between paramedics & GP’s and CCU even more important. The GP’s and paramedics have a pivotal role to play here. However as our service develops we will examine where and when it is feasible to off er PPCI to those pati ents that can be transported here within required ti me limits.

We may have the most remote catchment area in Europe – but we can also boast the most scenic! It’s also a great place to live and work with so many initi ati ves coming to fruiti on. Through necessity we’ve developed roles and practi ces that are the envy of many ‘big centres’.

What do you do away from work eg hobbies etc...?

What ti me away from work?? Although I have a clinical director who runs my training organisati on I remain as Managing Director and Clin-ical Lead, so I am sti ll required to provide regular input there.

I’ve relocated to a wonderful part of Scotland and so get out and about the hills as oft en as I can. I am forever hopeful that my golf handicap may come down, although there is no real cause for hope there!

CardiologyHD.comSee our Management Hot Topics online today:

• Surviving the Government Spending Cuts

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• Are MBA’s a good idea?

• Non-Professional Staff

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• Future Changes?


November 18-19

Bristol PCI Course 2010The Educati on Centre, Bristol Royal Infi rmaryBristol, Englandwww.millbrookconferences.co.uk

November 22-23

Europe AF 2010London Hilton Metropole Hotel London, Englandwww.europeaf.com

November 25

BLT Course 2010 : Bifurcati on Lesion TreatmentNati onal Motorcycle MuseumSolihull, Englandwww.millbrookconferences.co.uk

November 25-26

13th Briti sh Society for Heart Failure Autumn Meeti ngQueen Elizabeth II Conference CentreLondon, Englandwww.bsh.org.uk

November 25-26

SHARP Annual Scienti fi c Meeti ngHilton Dunkeld House HotelPerthshire, ScotlandEmail: [email protected]

December 6-7

Heart Att ack: The Challenge IThe MidlandManchester, EnglandEmail: [email protected]

January 26 - 28, 2011

ACI 2011 : Advanced Cardiovascular Interventi on 2011London Hilton Metropole HotelLondon, Englandwww.millbrookconferences.co.uk

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Questi on on Page: 18

1. This 12-lead ECG shows characteristi cs of Brugada syndrome. Lead V1 and V2 demonstrate an ‘rSr1’ patt ern with a coved ele-vati on of the ST segment in these leads. This qualifi es as a type 1 Brugada ECG.

2. Since its introducti on as a clinical enti ty in 1992, the Brugada syndrome has progressed from being a rare disease to one that is second only to road traffi c accidents as a cause of death among young adults in some countries. The syndrome is asso-ciated with a high risk for sudden cardiac death in young and otherwise healthy adults, and less frequently in infants and chil-dren. The syndrome is esti mated to be responsible for at least 4% of all sudden deaths and at least 20% of sudden deaths in pati ents with structurally normal hearts. Brugada syndrome is defi niti vely diagnosed when a type 1 coved ST-segment eleva-ti on is observed in at least one right precordial lead (V1 to V3) in the presence or absence of a sodium channel– blocking agent, and in conjuncti on with one of the following: documented ven-tricular fi brillati on (VF), polymorphic ventricular tachycardia (VT), a family history of sudden cardiac death at <45 years old, coved-type ECGs in family members, inducibility of VT with pro-grammed electrical sti mulati on, syncope, or nocturnal agonal respirati on.

3. Inheritance of Brugada syndrome occurs via an autosomal dominant mode of transmission. The fi rst and only gene to be linked to Brugada syndrome is SCN5A, the gene that encodes for the α subunit of the cardiac sodium channel gene.

More than 80 mutati ons in SCN5A have been linked to the syndrome and about 2 dozen of these mutati ons have shown to result in loss of functi on because of failure of the sodium channel to express; this can be seen as a shift in the voltage and ti me dependence of sodium channel current acti vati on, inacti vati on, or reacti vati on; entry of the sodium channel into an intermediate state of inacti vati on from which it recovers more slowly; or accelerated inacti vati on of the sodium channel.

A second locus on chromosome 3, close to but apart from the SCN5A locus, was linked recently to Brugada syndrome in a large pedigree in which the syndrome is autosomal dominant inher-ited and associated with progressive conducti on disease, a low sensiti vity to procainamide, and a relati vely benign prognosis.

SCN5A mutati ons account for about 18% to 30% of Brugada syn-drome cases. A higher incidence of SCN5A mutati ons has been reported in familial than in sporadic cases. Of note, negati ve SCN5A results do not rule out causal gene mutati ons because, in general, the promoter region, crypti c splicing mutati ons, or the presence of gross rearrangements is not investi gated.

Full arti cle referenced from: C Antzelevitch, P Brugada et al. Brugada Syndrome. Report of the Second Consensus. Endorsed by the Heart Rhythm Society and the European Heart Rhythm Associati on. Circulati on. 2005; 111: 659-670.



AnswerSophie Blackman’s ECG Challenge

Mr Tim LarnerDirector / FounderLatest Technology & All-Round Computer Geek

Future Technology News >>>The Fraunhofer Insti tute in Germany is working on a new system to measure cardiac pressure “on-demand, anywhere”. Batt ery-free miniature sensors are implanted into the heart wall with the aid of a catheter and can give physicians up to 200 measurements per second post procedure.

Source: Fraunhofer-Gesellschaft

Tech companies IMEC & the Holst Center have designed an applicati on for Android phones allowing you to monitor your heart rate. With sensors att ached to the body via a necklace, the data can be wirelessly transmitt ed to the phone and within seconds provide a detailed ECG and heart rate monitoring report. This can then be

stored or emailed to your GP.

Source: IMEC

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Copyright © 2010 McKesson Corporation and/or one of its subsidiaries. All rights reserved. Horizon Cardiology is a trademark of McKesson Corporation and/or one of its subsidiaries.

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