The evidence - and what can be donedontfailonheartfailure.com/content/heartfailure.pdf · hundred women, and 4 in every hundred men.4 At least 605,000 people in the UK are believed

The evidence - and what can be done

June 2013

Contents

4 Executive Summary

5 Heart Failure

6 A patient’s story: Emma, Leeds

7 Implantable cardioverter defibrillators and cardiac resynchronisation therapy

8 A patient’s story: Stephanie, Sunderland

9 How ICDs and CRT-Ds help heart failure patients and the NHS

10 A patient’s story: Janey, London

11 What can be done?

12 Glossary

13 Appendix: NYHA Classification – The Stages of Heart Failure

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The evidence - and what can

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Executive Summary♥ A person has heart failure if their heart is

unable to pump sufficient blood to meettheir body’s needs. Causes range fromhypertension to a heart attack to a virus.Patients suffering heart failure developincreasing breathlessness and fatiguewhen carrying out daily activities – andultimately at rest. Consequently, ability towork is greatly impaired along with healthand quality of life.

♥ Untreated, heart failure has a survival ratesimilar to cancer - and over a third die within1 year of diagnosis.

♥ Heart failure eventually affects 3 in everyhundred women, and 4 in every hundredmen.

♥ Heart failure currently imposes huge costson the NHS. It accounts for 5% of allemergency hospital admissions and 2% ofall NHS hospital bed days.

♥ Implantable devices like ICDs and CRT-Dshave an established role in the treatment ofpatients, with a large body of high qualityevidence supporting their safety andefficacy. In a unique collaboration bymedical device manufacturers, 12,000heart failure patients were followed over aperiod spanning seven and a half years - in13 individual randomised clinical trials. Theresults are published here for the first time:the best and most robust informationavailable on the impact of CRT and ICD interms of mortality, health related quality oflife and hospitalisations.

♥ Patients who received CRT-Ds implantshad a 42% lower death rate.

♥ ICDs also had a dramatic effect. Patientswho received ICD implants had a 29%lower death rate.

♥ For patients with mild to moderate heartfailure, ICDs reduced monthly admissionrates to hospital by 20%, and CRT reducedthem by 33%.

♥ The effect on patients with severe heartfailure is even more pronounced, with CRToffering a 40% reduction in monthlyadmission rates.

♥ The UK falls embarrassingly far behindother countries in provision of implantabledevices for heart failure patients. There isalso huge variation within England andWales. The implant use suggested by NICEfor both devices has not been reached, andthe UK remains in the lower quartile ofEuropean averages. As a result, heartfailure is killing people, lowering quality oflife and the UK is spending a lot of moneytreating it badly.

♥ Heart failure should not be viewed as apalliative condition, with sufferers waiting todie. More should be done to improvepatients’ quality of lives, better managetheir condition to reduce unnecessaryhospitalisations and save the NHS money,and help reduce mortality.

♥ The National Institute for Health and CareExcellence (NICE) is currently reviewingICDs and CRT-Ds. New and improvedguidance can help improve implant ratesand ensure the credibility of NICE and theUK as a centre for medical technologyinnovation. Parliamentarians, clinicians,patient groups and members of the publiccan all help ensure this.

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The evidence - and what can

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Heart FailureA person has heart failure if their heart is unableto pump sufficient blood to meet their body’sneeds. Causes range from hypertension to aheart attack to a virus.

Untreated, heart failure has a survival ratesimilar to cancer - and over a third die within 1year of diagnosis.1

Patients suffering heart failure developincreasing breathlessness and fatigue whencarrying out daily activities – and ultimately atrest. Consequently, ability to work is greatlyimpaired along with health.

Heart failure currently imposes huge costs onthe NHS. It accounts for 5% of all emergencyhospital admissions and 2% of all NHS hospitalbed days.2

Patients with heart failure often have a poorquality of life. Over a third experience severe andprolonged depressive illness).

WHO IS AFFECTED BY HEART FAILURE?

Heart failure eventually affects 3 in everyhundred women, and 4 in every hundred men.4

At least 605,000 people in the UK are believedto suffer from heart failure.5

Case study: Lynn, ChesterFrom leading a very hectic life, the simple actof blackberry picking or walking even a fewhundred yards on even ground defeated her.She was told her consultant: “No more flying,no more stressful working - and by the wayit may lead to heart surgery.”

A patient’s account: James, Lancashire“I had to get used to the idea of heart failurequickly, and learn how to handle the fatigue,breathlessness, and the swelling of feet andankles. I had to learn the function of a heartthat was working at a miserly twenty five percent efficiency. I felt I was dying in front of myfamily. In effect I was.”

1 Department of Health Cardiovascular Disease Outcomes Strategy, p.342 Ibid3 Ibid

4 NICE technology appraisal guidance 120, National Institute for Health andClinical Excellence, p5

5 UK population of 63.1m (2011 census), multiplied by 3% of population aged65-74, 7% of 75-84 and 14% of those 85+ (Ibid, p5). As this figure does not

include under 65s it is an underestimate of the total.

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A patient’s story: Emma, Leeds

Heart failure has changed my life completely. Ican only work part time (I have to do so as wecannot get any help as I "am not ill enough")even though everyday tasks take me muchlonger. I cannot make plans too far ahead andam often too tired to even socialise or undertakehousework due to the extreme fatigue I sufferfrom along with the arrhythmias which appear atany time of the day or night.

I had been finding it increasingly difficult to walkanywhere at all, could not breathe laying down

flat at night and was breathless even just talking.I did attend the ante-natal clinic at my local NHShospital who kept me waiting 2.5 hours to haveme in and out of there in 5 minutes, telling methat I was simply pregnant and that was to beexpected! Having been pregnant before I knewthat I had not experienced that and wasextremely worried. My midwife then becameextremely concerned as did my GP who sent aletter and me back to my local hospital A&Edepartment. If he had not insisted and done this,myself and my son may not have been heretoday, I truly believe he saved my life and that ofmy then unborn child.

Once in the hospital every test imaginable wasrun, with my heart being the last thing theychecked as I was "far too young for it to be myheart" (I was 31 years old at this point). I had tohave a nurse wait outside the bathroom and betaken everywhere in a wheelchair as I washaving life-threatening arrythmias constantlyeven whilst sleeping or sitting doing nothing.

The Peri-Partum Cardiomyopathy I wasdiagnosed with meant I could not have any morechildren and at age 31 had to be sterilised whichas there was not enough known about thedisease I was pressured into doing so only beinggiven half an hour to decide as it was done atthe same time as they delivered my son. I havesince been advised this should not havehappened so it makes me extremely angry thatI had that choice taken away from me.

I worry that I will not see my youngest son growup, he even thought until recently that allmummies had poorly hearts as that is all he'dever known, this makes me very sad.

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The evidence - and what can

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Implantable cardioverter defibrillators and cardiac resynchronisation therapy Implantable devices have an established role inthe treatment of patients, with a large body ofhigh quality evidence supporting their safety andefficacy.

Many people with heart failure also suffer fromabnormal rhythms in their heart which can provefatal. ICDs jolt the heart back into its naturalrhythm when it goes out of rhythm. CRT-Ds helppace the heart to enable it to pump blood moreefficiently and include a defibrillation function,offering protection from sudden cardiac death.

ICDsImplantable cardioverter defibrillators (ICD)continuously monitor the heart for arrhythmiaand maintain normal heart rate using small,painless electrical signals. They deliver highenergy shock therapy (defibrillation) in the eventof a potentially life-threatening arrhythmia,protecting against sudden cardiac death.

CRTCardiac resynchronisation therapy (CRT) useselectrical stimulation to resynchronise thecontraction of the ventricles, thereby improvingpumping efficiency. Devices that deliver CRTalone are known as CRT-P. While they improveHF symptoms, they do not offer direct protectionagainst sudden cardiac death.

CRT-DsCRT-D devices combine CRT with a defibrillationfunction, offering protection from sudden cardiacdeath in addition to the benefits of CRT.

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A patient’s story: Stephanie, Sunderland

Stephanie was 22 - and her first child Olivia just14 months old - when she collapsed, lookingand feeling awful. She was rushed to hospitalwith severe heart failure. After spending threeweeks in hospital she was put on drugtreatments and discharged.

Over the next five years she was treated at herlocal hospital but had several more collapsesand emergency admissions to hospital withsevere heart failure. Doctors told her she mighthave myocarditis and she should not becomepregnant again.

After a very severe bout of heart failure, she wasreferred to experts at the Freeman Hospital inNewcastle. There she was diagnosed withdilated cardiomyopathy and given animplantable cardioverter defibrillator (ICD) witha bi-ventricular pacemaker. Her heart functionbegan to improve and she started to feel muchbetter.

Three years later, when she was 31, shediscovered she was pregnant again. She waslooked after by a team of specialists and despitehaving problems in the early months, the birthwith epidural was straightforward.

Baby Owen was a healthy 6lbs but Stephanie’sheart function suffered and she spent twomonths in hospital recovering. But soon herheart function improved again: so much so thatby 2012, when she needed a new ICD, doctorssaid she did not need one. But she still suffersevery day from heart failure symptoms, mostlytiredness, and struggles to keep up with herfamily and friends.

She said: “With appropriate care, treatment andsupport, things can get better.”

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The evidence - and what can

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How ICDs and CRT-Ds help heart failure patients and the NHSIn a unique collaboration by medical devicemanufacturers, 12,000 heart failure patientswere followed over a period spanning seven anda half years - in 13 individual randomised clinicaltrials. The result is the best and most robustinformation available on the impact of CRT andICD in terms of mortality, health related qualityof life and hospitalisations. They are publishedhere for the first time.

In 2006, ICDs were judged by the NationalInstitute for Clinical Excellence to provide goodvalue for money in secondary prevention ofsudden cardiac death. No studies have emergedin the last seven years to contradict thisevidence base and meanwhile the price hasdropped in real terms, strengthening theconclusions NICE reached about the value ofICDs. The focus of the new research wastherefore on primary prevention.

Death rates

CRT-Ds save the most lives. Patients whoreceived CRT-D implants had a 42% lower deathrate compared to patients who receive the bestknown drugs – known as Optimal PharmacologicTherapy (a hazard ratio of 0.58).

ICDs also had a dramatic effect. Patients whoreceived ICD implants had a 29% lower deathrate compared to patients who receive OPT (ahazard ratio of 0.71).

CRT-Ds and ICDs therefore bring down a veryhigh death rate. Without the devices, 85% ofheart failure patients in the bottom fifth forpredicted survival time died within four years.Even for those in the top fifth for predictedsurvival time, 15% died within four years.

Younger patients and male patients appear tobenefit more from ICDs, but less than othergroups from CRT. This is likely to be due to therelatively higher rate of sudden cardiac deathrelative to other causes in younger and malepatients.

Hospitalisation rates

ICDs and CRT-Ds reduce admissions to hospital– which is better for patients, medical staff andthe NHS.

For patients with mild to moderate heart failure(NYHA classes I, II and III), ICD therapy reducedmonthly admission rates to hospital by 20%, andCRT reduced them by 33%.

The effect on patients with severe heart failure(NYHA class IV) is even more pronounced, withCRT offering a 40% reduction in monthlyadmission rates.

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A patient’s story: Janey, LondonIn April 2009 I gave birth to a beautiful baby boy.Within 4 months I noticed that I was gettingbreathless pushing the buggy uphill.

However, I started waking up at night strugglingto breath. During a period when my son was nolonger waking me up and I was tired I consideredthis unusual. Still, at first, I thought it might passand, not one to run to the GP at the sight of anysmall ailment, I continued. But as it started tohappen every night and I could anticipate that itwould happen, I booked a GP appointment.

The GP on duty looked at me, said that I had aclear chest and told me I was stressed as a newmother. He said to try blowing into a brown paperbag whenever it happened. I was dismissed andmy symptoms not investigated sufficiently if atall.

I struggled throughout the holiday, struggling towalk downhill with the buggy or even carryinganything; lying down doing nothing was even astruggle as I felt continuously short of breath. Wedecided to fly back home early.

I went to A and E at Barnet Hospital on my returnhome and was immediately admitted. A chest X-ray showed a hugely inflated heart and myoxygen levels dropped on a short walk. I wasdiagnosed with dilated cardiomyopathy andadmitted overnight. No one took the time toexplain to me exactly what was wrong and I felt

alone and frustrated that I didn't understand whatwas going on…. one of the key things simply notunderstood by others about heart failure. Thatand that people who often look fine on theoutside aren't necessarily functioning well orfeeling well on the inside.

I feel I have accomplished so much havingreturned to work as a solicitor in London (albeiton a part time basis) whilst bringing up my sonrather than accepting never working again.However, it is an uphill walk to the bus stop andto the tube station which I cannot cope with ontop of the tube commute so I pay £5 each day topark at the station car park. This is becoming aheavy financial burden which may eventuallyoutweigh staying at work and paying for nurseryfees.

Usual tasks others take for granted such asdoing the washing, hanging it up, cooking dinner,going to the shops for groceries, changing bedsheets etc can be a struggle.

Every day I commute on the tube to work, Istruggle with not getting a seat at times as I lookfine on the outside and find it difficult to askothers for a seat as knowing they too look fineon the outside means little.

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The evidence - and what can

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What can be done?

Falling device costs and increasing battery lifeought to mean that more patients can be helpedeach year. In practice, implant rates are oftendetermined by other factors, and the UK fallsembarrassingly far behind other countries inprovision and care for heart failure patients.

In England and Wales, total new implants of•ICDs are 72 per million people.For new and replacement CRT (CRT-P and•CRT-D combined), the rate is 114 per millionpeople.

In the United States, there are 577 CRT-D orICD implants per 1 million. The Europeanaverage is 155 per million. In the UK, there areonly 104 implants per million.6 At 70 per millionpopulation, the UK ranks well below countriessuch as Poland and Slovakia for ICD implantrates (which exceed 140 and 90 per millionrespectively).7

Device implantation rates also vary considerablywithin England and Wales:

From 34 to 131 per million population for•new ICDs; andFrom 68 to 182 per million for new and•replacement CRT devices.

The implant use suggested by NICE for bothdevices has not been reached, and the UKremains in the lower quartile of Europeanaverages. As a result, heart failure is killingpeople, lowering quality of life and the UK isspending a lot of money treating it badly.

Heart failure should not be viewed as a palliative

condition, with sufferers waiting to die. Moreshould be done to improve patients’ quality oflives, better manage their condition to reduceunnecessary hospitalisations and save the NHSmoney, and help reduce mortality.

The National Institute for Health and CareExcellence (NICE) is currently reviewingICDs and CRT-Ds. New and improvedguidance can help improve implant rates andensure the credibility of NICE and the UK asa centre for medical technology innovation.

Parliamentarians, clinicians, patient groupsand members of the public can help bywriting to Health Ministers, to NICE and toNHS England supporting improved patientaccess to medical technology for treatingheart failure, including ICDs and CRT-Ds. Forfurther information and draft letters, pleasecontact James Gittings [email protected] and 020 7731 6963.

6 European utilization of the implantable defibrillator: has 10 years changed the‘enigma’?, A. John Camm and Seah Nisam, European Society of Cardiology

(2010) 12, pp.1064-1065

7 Cardiac Rhythm Management UK National Clinical Audit Report 2011, DavidCunningham, Richard Charles, Morag Cunningham, Tracy Whittaker,

UCL/NICOR, p28

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Glossary

CRTCardiac resynchronisation therapy (CRT) useselectrical stimulation to resynchronise thecontraction of the ventricles, thereby improvingpumping efficiency. Devices that deliver CRTalone are known as CRT-P. While they improveHF symptoms, they do not offer directprotection against sudden cardiac death.CRT-D devices combine CRT with adefibrillation function, offering protection fromsudden cardiac death in addition to the benefitsof CRT.

Hazard ratioIn drug and technology studies, the ratio ofdeath rates of the treated population to thecontrol population – either untreated orreceiving a different treatment.The lower the hazard ratio, the better thetechnology or drug compares to the alternative.If the treated population dies at half the rate ofthe control population, the hazard ratio is 0.5. Ifthe treated population dies at twice the rate ofthe control population, the hazard ratio is 2.

ICDImplantable cardioverter defibrillators (ICD)continuously monitor the heart for arrhythmiaand maintain normal heart rate using small,painless electrical signals. They deliver highenergy shock therapy (defibrillation) in theevent of a potentially life-threateningarrhythmia.

NICEThe National Institute for Health and CareExcellence. NICE approves and deniesmedical technology and treatments to NHSpatients. It makes its decisions based on itsassessments of their cost and the years andquality of life patients gain from the treatmentrelative to the cost and quality of life gains ofalternative treatments.

NYHA classes I, II, III, IVSee Appendix

OPTOptimal Pharmacologic Therapy. The bestknown drug treatment for a condition.

Primary preventionThe prevention of illness or disease insusceptible individuals or populations.

Real termsAdjusted for inflation. A real terms priceincrease means the price rose higher thaninflation. A real terms price decrease meansthe price rose by less than inflation, although itmay still be a higher nominal price.

Secondary preventionMedicine aimed at preventing the progress ofan illness or disease.

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Appendix: NYHA Classification – The Stages of Heart Failure8

In order to determine the best course of therapy,physicians often assess the stage of heart failureaccording to the New York Heart Association(NYHA) functional classification system. Thissystem relates symptoms to everyday activitiesand the patient's quality of life.

Heart Failure Class I (Mild)No limitation of physical activity. Ordinaryphysical activity does not cause undue fatigue,palpitation, or dyspnea (shortness of breath).

Heart Failure Class II (Mild)Slight limitation of physical activity. Comfortableat rest, but ordinary physical activity results infatigue, palpitation, or dyspnea.

Heart Failure Class III (Moderate)Marked limitation of physical activity.Comfortable at rest, but less than ordinaryactivity causes fatigue, palpitation, or dyspnea.

Heart Failure Class IV (Severe)Unable to carry out any physical activity withoutdiscomfort. Symptoms of cardiac insufficiency atrest. If any physical activity is undertaken,discomfort is increased.

8 Questions About HF, Heart Failure Society of America, athttp://www.abouthf.org/questions_stages.htm

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