Interventional cardiology

Cardiac Angiography

Interventional CardiologyDr. Krisada Sastravaha M.D.

14 December 2012

Balloon Angioplasty

Stent and New Devices

Distal protection and Thrombectomy devices

Vascular Closure Device

Non-coronary Interventions

Charles Dotter1920 - 1985

Melvin P. Judkins1922 - 1985

Mason Sones1919 - 1985

Andreas Gruentzig1939 - 1985

Charles Dotter 1920 - 1985

Mason Sones1919 - 1985

Melvin Judkins1922 - 1985

Andreas Gruentzig1939 - 1985

Historic Time Line

Abele,Bentoff,and Myler developed a prototype coronary artery dilator catheter in 1970.

In 1976 Gruentzig miniaturized his peripheral balloon catheter to perform coronary angioplasty in a canine model and later human cadaver experiments.

In May 1977, in San Francisco, Gruentzig,Myler and Hanna performed coronary angioplasty for the first time in living human.

Pre During Post

LAD Lesion

INTERVENTIONAL CARDIOLOGY

INDICATIONS FOR PTCA

ASYMPTOMATIC , MILD SYMPTOMS SUDDEN CARDIAC DEATH SEVERE MYOCARDIAL ISCHEMIA FAILURE MEDICAL THERAPY INTOLERANT OF MEDICAL THERAPY PRIOR TO HIGH RISK SURGERY


INDICATIONS FOR PTCA

SYMPTOMATIC UNSTABLE ANGINA PECTORIS FAILED MEDICAL THERAPY LARGE AREA VIABLE MYOCARDIUM RESCUE PTCA PRIMARY PTCA IN ACUTE MI CARDIOGENIC SHOCK


CONTRAINDICATIONS

ABSOLUTE UNPROTECTED LEFT MAIN LESION LESS THEN 50% NO SURGICAL BACKUP

RELATIVE DIFFUSELY DISEASED SVG DIFFUSELY DISEASED NATIVE VESSELS

WITH GOOD DISTAL TARGETS


CONTRAINDICATIONS

RELATIVE (continued) BLEEDING DIASTHESIS PTCA OF NON-INFARCT VESSEL DURING

PRIMARY PTCA HIGH RISK ANATOMY FOR ABRUPT

CLOSURE SOLE VESSEL SUPPLYING HEART DIABETICS WITH MULTIVESSEL Dx

In the beginning, there were balloons

1977 – 1990 Success rate approached 90% Failures resulting in emergency CABG

about 5% Compared to CABG, equivalent initial

and 5 year outcome, except repeat procedures

Restenosis 20- 25%

Balloon Angioplasty (PTCA)

Catheter threaded through artery – usually femoral or radial to the aortic root

Guide wire is then inserted into the coronary artery and advanced past the area of stenosis


Balloon tipped catheter inserted over guide wire until balloon is in area of stenosis

Balloon is inflated pushing plaque against the vessel wall


Balloon inflation causes what has been called a “controlled injury” to the coronary artery.

On balloon deflation, there is some immediate recoil resulting in a loss of

15-30% of the inflated balloon diameter.

Complications of PTCA

Plaque rupture, may lead to: Thrombus formation Intimal flap

Arterial rupture Acute closure Sub-optimal result Restenosis

Requires further intervention to make vessel patent


MAJOR COMPLICATIONS

DEATH (0.5%-1%)

Q-WAVE MYOCARDIAL INFARCTION ( 1%-3%)

EMERGENT SURGERY (1%)


PROCEDURAL COMPLICATIONS

ACUTE CLOSURE (4%-8%) SPASM THROMBUS DISECTION EMBOLISM TREATABLE WITH STENTS

PERFORATION

Limitation of Coronary

Intervention. Specific lesion characteristics may pose

challenges for coronary intervention. Anatomic classification. High risk lesions : Diffuse,excessive vessel

tortuosity, extremely angulated, total occlusion,degenerated vein grafts.

High risk lesions are associated with lower initial success rate and high incidence of recurrent stenosis.


DISSECTION


ULCERATED PLAQUE

ACC-AHA Coronary Artery Lesion Classification

Types of Lesions

Type A lesions Discrete (<10 mm length) Concentric Readily accessible Non-angulated segment <45o

Smooth contour Little or no calcification

Types of Lesions

Type A lesions: Less than totally occlusive Not ostial in location No major branch involvement Absence of thrombus

Type A

DISCRETE

Types of Lesions

Type B lesions Tubular (10-20 mm length) Eccentric Moderate tortuosity of proximal segment Moderately angulated segment >45o

<90o Moderate to heavy calcification

Types of Lesions

Type B lesions Total occlusions < 3 months old Ostial in location Bifurcation lesions requiring double

guide wires Some thrombus present

Type B1- B2 lesions

Type B1 lesions have a single adverse B characteristic.

Type B2 lesions have two or more adverse characteristics

Type B1

ECCENTRIC

THROMBUS

Type B2 (2 Charastics)

ECCENTRIC TUBULAR ECCENTRIC

IRREGULAR

Types of Lesions

Type C lesions Diffuse (>2 cm length) Excessive tortuosity of proximal

segment Extremely angulated segments >90o

Total occlusions > 3 months old

Types of Lesions

Type C lesions Inability to protect major side branches Degenerated vein grafts with friable

lesions

Type C

OLD OCCLUSION

DIFFUSE FRIABLE

IMPLICATIONS

Type A 92% Success, 2% Complications

Type B1 84% Success, 4% Complications

Type B2 76% Success, 10% Complications

Type C 61% Success, 21% Complications

Then came the new devices…

1990 all were investigational Approval 1992 – 1994 Success approached 98% Stents are embraced Need for emergency CABG < 1% Restenosis 10-15%

Directional Coronary Atherectomy

Directional Atherectomy

Directional Atherectomy

First alternative to angioplasty. Can be applied selectively to eccentric

disease in the vessel wall, which may be cut out and retrieved.

The cutter rotates at about 2000rpm and as it is advanced it shaves material, which become embedded in the cutting chamber.

Potential concern : Perforation/Dissection. No clear clinical benefit of DCA in

controlled trials : CAVEAT I and II

Laser Angioplasty

Laser

• Laser ablation

• Fluorescence – guided laser angioplasty

• Directional laser atherectomy

• Laser – assisted thrombolysis

• Laser – directed myocardial revascularization

Laser Angioplasty

Catheter employs buldle of optic fibers delivering ultraviolet laser energy.

Small vessels,thrombotic lesions. Trials : Increased restenosis.

Rotational Atherectomy

04/07/2023



Diamond chip-covered burr, which rotates at 150,00-200,000rpm.

Calcified lesions especially related to ostia of the vessel.

Lesions that resist balloon dilatation and bifurcation lesions.

Coronary spasm and no reflow ocure with increased frequency.

Trials : ARTIST and ERBAC

Rotational Atherectomy (Rotoblator)

Rapidly spinning burr ablates plaque tissue Differential cutting Used to debulk lesions Followed with balloon dilatation

.009 Guidewire with .017 spring tip

Elliptical burr coated with diamond chips

Aspects of Technique by LocationA. Body of LMS (N = 2/44) - simplest NB guidewire bias in eccentric lesion

PRE

POST

Particulate Size Distribution

5 studies, 33 experiments(Models= Carbon blocks; Thermal injury porcine coronary artery; Diseased cadaver peripheral arteries)

98.2% < Red Blood Cell Diameter

99.97% < 30 um (theoretically the smallest protection device)

99.3% < Capillary Diameter

Mean particle size: 1.92 um (± .1 um)

Average Particle Distribution

• Fall from favour/use late 1990s

1. unfavourable restenosis data (ERBAC, ARTIST)2. regarded as time-consuming to use

Cutting Balloon

3 to 4 atherotomes mounted on balloon. Capable of protruding outside of the

inflated balloon. Approved for lesions not dilatable by

standered balloon technique. Considerable interest in using for in-stent

restenosis. Little data avialable to suggest

superiorirty over alternative technology.

Cutting Balloon

Advantages Controlled

dissection Non-compliant

balloon

Disadvantages• Crossability • Flexibility

Atherotomes on balloon

Stent

What is a Stent?

A small tubular mesh usually made of either stainless steel or Nitinol.

Inserted into stenotic arteries to keep the lumen patent often used after PTCA.

Used at various sites including the coronary, renal, carotid and femoral arteries.

Non-arterial uses e.g. in bronchus, trachea, ureter, bile duct.


Palmaz “Corinthian” Iliac artery stent

Gianturco-Roubin II Stent

Second Generation Stent

Deployed Stents

Medtronic S670 Ring Stent

Cordis Crown Tubular Stent

ACS Tetra Tubular Stent

Stenting

Most PCI are performed with the use of stents

Wire mesh coil pushed against vessel wall to prevent closure of the vessel post procedure

Bifurcation LesionsJOSTENT BifurcationJOSTENT Bifurcation

XIENCE SBA Full Deployment with Side Branch Preservation

XIENCE SBA is designed to allow for easy crossing of additional stent into side branch

Portal structure is well apposed to the side branch ostium

Max post-dilatation diameters

3.75 mm main branch 3.0 mm side branch

Main Branch ID

Side Branch Access ID

Stent Length

3.0 mm 2.5 mm 18 mm

Distal

Proximal

Side Branch Portal

In Vivo Porcine Model

XIENCE SBA Delivery SystemBased Upon MULTI-LINK FRONTIER Concept

Dual lumen tip

Joining mandrel inserted through OTW inner member

Main Branch (RX)

Side Branch (OTW)

Design Features ObjectivesSingle Tip Delivery • Ease of use

• Avoid wire wrap• 7F guide catheter

compatible

Simultaneous Balloon Deployment

• Deploy stent quickly• Minimize plaque shift

Side Branch Portal • Provide ostial scaffolding

Dedicated XIENCEXIENCE Technology Dedicated to Side Branch

Access

Side Branch Access and Preservation

XIENCE Technology

Following deflation, the delivery system is retracted, preserving access in both branches.

XIENCE SBA is currently a pipeline product at Abbott Vascular. Not available for sale. Information contained herein for presentation outside of the U.S. and outside Japan. Not to be reproduced, distributed, or excerpted.

3. Position guide wire in the side branch and advance system to the carina

1. Advance system into the main branch, over a conventional RX wire

2. Retract joining mandrel to release OTW side branch tip; insert exchange length guide wire

4. With a one inflation device, stent is deployed with a single, simultaneous inflation


XIENCE SBA Deployment Sequence

All illustrations are artists’ rendition.


XIENCE SBA is Designed to Treat Lesions at Bifurcations

Standard workhorses may show a malapposed lateral wall and train-wrecking at and around the side branch after post-deployment balloon dilatation

XIENCE SBA shows complete lateral wall apposition and even stent coverage around the side branch


Side Branch Access Maintained Throughout the Procedure

Wires maintained after system withdrawal for further treatment if needed


Simultaneous Balloon Inflation May Reduce Plaque Shift

As a result of plaque shift, side branch occlusion can occur 5-26% of the time and is associated with adverse events¹

1. S Garg et al. Interventional Cardiology 2006. 2. AJ Lansky et al. EuroIntervention. 2010;6 Suppl J:J44-J52.

• NIRVANA study results showed higher rate of MI due to side branch occlusion¹

• SPIRIT III showed a higher rate of MI for side branch occlusion subset²

XIENCE SBA Deployment Sequence

1 2 3

4 5

1. System delivered to MB via RX wire2. Joining mandrel removed, releasing

SB tip; insert exchange length GW into the SB

3. Advance system to carina4. Inflate both balloons with a single

inflation device5. After system removal, both guide

wires remain for further treatment if desired

Coronary PerforationJOSTENT Stent GraftJOSTENT Stent Graft

• Ultra thin layer of expandable PTFE is placed between two stents, welded at it’s ends

• effectively seals off the vessel wall for perforations, aneurysms and can be beneficial in life saving situations

• Ultra thin layer of expandable PTFE is placed between two stents, welded at it’s ends

• effectively seals off the vessel wall for perforations, aneurysms and can be beneficial in life saving situations

STENTS

Currently over 70% of all interventions on de novo lesions involve stent deployment.

Address the two major limitations of angioplasty : acute occlusion and restenosis.

Two major shortcoming of PTCA, elastic recoil and constrictive remodeling, are eliminated by stents.

The superiority of stents over PTCA in reducing restenosis has been demonstrated in several clinical trials:

STRESS - 29%Vs 43% BENESTENT - 22% Vs

32% REST -

18% Vs 32%

Restenosis

7 Days 7 Days 90 Days90 Days

In-stent restenosis is a hyper-proliferative disorder.

The Problem

Restenosis

Recurrence of luminal narrowing after angioplasty is termed restenosis.

Mechanism involves elastic recoil, neointimal hyperplasia and arterial remodeling.

Usually occurs within the first 2-6 months. Balloon angioplasty of native de novo

coronary lesions was associated with restenosis rate of :

- 32% in BENESTENT TRIAL - 42% in STRESS TRIAL - 57% in CAVEAT TRIAL.

Stent Failure

Restenosis20-30 %

7 Days 7 Days 90 Days90 Days

Mechanism of Restenosis

i shear stress Intimal Hyperplasia i lumen h shear stress If baseline shear stress not restored –

continuing intimal hyperplasia and RESTENOSIS

Factors Which Contribute to In-stent

Restenosis Thrombus/platelet/fibrin adherence to

stent struts. Metabolic disorder/smoking/atherogenic

diet. Small lumen diameter. Stress concentration at end of stent. Flow disturbance within stented region.

Brachytherapy

04/07/2023Cardiac Angiography

Coronary Brachytherapy

Pre

Post Dilatation

RadiationTreatment or Placebo

Diffuse lesion

Residual stenosis @ stent edge

Residual stenosis @ stent edge

04/07/2023Cardiac Angiography

Absorb BVS: The 4th Revolution in Percutaneous

Coronary Intervention

1977Balloon Angioplasty

(PTCA)

BareMetal Stents

(BMS)

Coronary Drug

Eluting Stents (DES)

AbsorbBioresorbable

Vascular Scaffold (BVS)

1977 1988 2001 Today

After implant.

After resorption.

Poly (L-lactide)(PLLA)

Based on provenMULTI-LINK pattern

Naturally resorbed, fully metabolized*

World-class deliverability

Similar dosedensity andrelease rateto XIENCE V

Poly (D,L-lactide)(PDLLA)

Naturally resorbed, fully metabolized

Absorb BVS: Design Components

Bioresorbable

Scaffold

Bioresorbable

CoatingEverolimus

XIENCE VDelivery System

*Except for platinum markers

Description of the ABSORB Device

4. Description & usage of study device

ABSORB

Bioresorbable Vascular Scaffold

BVS Design Optimization:

Objectives

Cohort A

Cohort B Photos taken by and on file at Abbott Vascular.

• More uniform strut distribution

• More even support of arterial wall

• Lower late scaffold area loss– Maintain radial strength for at least 3 months

• Unchanged:

– Material, coating and backbone– Strut thickness– Drug release profile

ABSORB BVS Cohort A, Cohort B and XIENCE V

Cohort A and B – poly-L-lactide (PLLA) covered with poly-D,L-lactide (PDLLA), containing and controlling release of everolimus

XIENCE V –cobalt chromium with fluoropolymer with controlled release of everolimus

ABSORB BVS Cohort A

ABSORB BVS Cohort B

XIENCE V

Water in surrounding vascular cells and blood penetrates polymer matrix Long polymer chains become shorter and shorter

1 3 6 24 Months

Support

Mass Loss

Tie chains

Initially, hydrolysis preferentially cleaves amorphous tie chains, leading to a decrease in molecular weight without altering radial strength

When enough tie chains are broken, the device begins losing radial strength

Molecular Weight

12 18

How Absorb Resorbs

6 months

12 months

18 months

24 months

36 months

48 months

Porcine coronary artery model

Degrading polymer is first replaced by extracellular matrix,

then by cells

Restoration of Vascular Integrity

Based on preclinical histology evidence. Data and images on file at Abbott Vascular.

91°

88°

ABSORB BVS

Absorb BVS Conformability

Respects the Natural Contour of the Vessel

Serruys, PW. , TCT 2009

Are rigid permanent scaffolds the way of the

past? Fracture

I=single strut fracture, II=2 or more struts fracture without deformation, III=2 or more struts fracture with deformation, IV=multiple fractures with acquired transection without gap,

V=multiple fractures with acquired transections with gap

Among 200 DES lesions in the CVPath registry, stent fracture was documented in 51 (SES 32, PES 19) lesions (29%).

Grade V fracture was identified in 9 (SES 6, PES 3) lesions.

I II III IV V

Nakazawa G, et al. J Am Coll Cardiol 2009; 54: 1924-1931.

88Metal fatigue can result in strut fracture, triggering local inflammation, focal restenosis, and/or stent thrombosis

Periprocedural complications

In 1% to 3%, procedure is complicated in hospital by a severe adverse event, while in the remainder, the procedure is unsuccessful either because a guidewire or device could not be delivered across the lesion or because the criteria for success are not met.

Difficult angioplasty Scenarios

Chronic total occlusion. Calcified lesion. Ostial lesion. Bifurcation lesion. Long lesion. Bypass conduit.

Severe Adverse Events

Death (0.5% to 1%) Q wave myocardial infarction (1% to3%) Need for emergent CABG (less than 1%) Acute Occlusion . Dissection. Thrombosis, spasm, embolism. Perforation. Significant CPK elevation.

No-Reflow Phenomenon

Distal embolization of thrombus and/or atheromatous debris .

Thrombotic lesions, degenerated vein grafts are high risk .

Thrombectomy Devices

To treat thrombus containing lesion and prevent distal embolization

What happens if you just stent thrombus

The importance of clot to coronary intervention

The presence of thrombus increases the risk of complication

Clot can be eliminated by:Auto-lysis, particularly if facilitated by

i.v. heparin x 1 weekp.o. coumadin x 6 weeks

Dissolutioni.c. thrombolytic (Urokinase) 100-250,000 U/hr for 6 - 12 hours? i.v. Aciximab bolus

AspirationTransluminal extraction catheter (TEC)X-Sizer, Export, etc. Possis AngioJet

FragmentationAcolysis device (ultrasound)OmniSonics

Intra-coronary thrombolysis

Transluminal Extraction Catheter

TEC Device

Transluminal extraction catheter. 750rpm. Aspirate debris as it is advanced through

the vessel. The device appear most suitable thrombus

laden vessels. Distal embolization, no reflow and CPK

elevation. No significant long term benefit.

Transluminal Extraction Catheter (TEC)

Large guide Low efficiency Low success High complic.

ev3 Inc.

Diver C.E.™ Clot Extraction Catheter

Diver CE in Action!!

AMI: RCA occluded

Thrombus removal with Diver CE

Restoration of flow

Final Result

1

2

3Fluoroscopy provided with permission from Burzotta, et al

AMI with RCA Thrombus

AngioJet LF140

Angiojet

Flexible catheter. Saline injected at high speed. Venturi effect is created. Fragments the thrombus and suck it

back up into the collecting bag. Used in situaltions in which there is

large thrombus burden.

ANGIOJET RHEOLYTIC THROMBECTOMY SYSTEMTHREE COMPONENTS

ANGIOJET RHEOLYTIC THROMBECTOMY SYSTEMTHREE COMPONENTS

Drive Unit • Generates 10,000 pounds per square inch (PSI)

pressure

• Monitors system performance to assure patient safety

• Versatile platform accommodates all AngioJet catheters

• Set up ease through lighted prompt menu

Pump Set • Isovolumetric balance between fluid delivery and

removal

• Effectively bridges non-sterile and sterile environment

Catheters

• Disposable catheters approved for a variety of indications

Angiojet of SVG Thrombus

The ev3 (EndiCOR) X-Sizer

• Thrombo atherectomy device

• 1.5, 2.0 and 2.3 mm cutters

• 7-9F guide compatible

X-TRACT: 30 Day MACE

17.0 17.4

1.0

15.8

1.8 1.5

16.9

0.30

5

10

15

20

25

Cardiacdeath

MI TVR MACE

Inc

ide

nc

e (

%)

X-SIZER Control

All p=NSAll p=NS

5.76.7

8.18.1

0

5

10

15

Large MI Death orlarge MI

Inci

den

ce (

%)

X-SIZER Control

X-TRACT: Impact of Thrombus

4.94.1

10.2 10.7

0

5

10

15

Large MI Death orlarge MI

Inc

ide

nc

e (

%)

X-SIZER Control

Thrombus pre (n=450)Thrombus pre (n=450)

60%60%

No thrombus pre (n=253)No thrombus pre (n=253)

54%54% 30%30% 17%17%

Distal Protection Devices

Distal Protection Device Concepts

Filter Device

Balloon Occlusion Device

Distal Protection Devices

The EPI FilterWire EX

The PercuSurge GuardWireand Export aspiration catheter

The AngioGuard Filter

Distal Protection

“The Most Frequent Complication of Distal Protection Devices is Distal Embolization”

(Device-, Operator-/Technique-, Lesion-related)

The 2 Principles of Distal Protection:

„You need distal embolizationto benefit from distal protection“

Limitations of Angiography


Intravascular Ultra Sound (IVUS)

• Ultrasound transducer mounted near tip of catheter

• Provides a 2-D image from inside-out of artery

• Allows for 360° visualization of vessel wall

IVUS: Method of Application

Courtesy of Steven E. Nissen, MD.

Ultrasound scan plane

Vessel

Catheter

High frequency sound waves echo off vessel walls and are sent back to system

System electronics process the signal

Normal angiographic image of vessel

IVUS – A New Dimension in Imaging

IVUS image of vessel with eccentric plaque

OLD GOLD STANDARD

NEW GOLD STANDARD

IVUS of native artery

IVUS of Stent

IVUS=intravascular ultrasoundNissen S, Yock P. Circulation 2001; 103: 604–616

Angiogram IVUS

Little evidence of disease

Atheroma

No evidence of disease

The IVUS technique can detect angiographically ‘silent’

atheroma

http://circ.ahajournals.org/content/vol103/issue4/images/large/hc0415065004.jpeg

Courtesy of Steven E. Nissen, MD.

IVUS Imaging of Intimal Plaque

Intravascular Ultra Sound (IVUS)

• Measurements can be made on the cross-sectional image to give luminal diameter

• IVUS shows plaque deposits much greater than angiography alone

Incomplete Stent Apposition


LIMITATIONS OF ANGIOGRAPHY

Virtual Histology

Interventional Technique

Kissing Balloon (or Stent)

Anchor Balloonfor CTO

Fujita et al Catheterization and Cardiovascular Interventions 59:482–488 (2003)

Retrograde Technique for CTO





TORNUS (Abbott Vascular)

Braided stainless steel flexible catheter able to enlarge the vessel by “screwing” through it

Tapered tip Rotate counter-clockwise to

advance Clockwise to withdraw No more than 10-20

rotations in the same direction

CTO device

CTO device

CTO device

Corsair (Vascular

Perspectives) Tapered soft tip Hydrophilic coating ASAHI brand braiding pattern, consisting of 8 thinner wires wound with 2 larger ones

Advancement: hold a torque device at all times to avoid ASAHI Corsair

and the guide wire to be rotated together Image the Corsair tip under fluoroscopy to make sure

that the tip is not trapped by the lesion avoid torque accumulation - limit the rotation to 10

times in one direction. To continue advancing ASAHI Corsair, rotate the opposite direction

Rotate the Corsair during removal into the guide

Non-coronary interventions


CAROTID STENOSIS


CAROTID STENOSIS AFTER STENTING


SUBCLAVIAN STENOSIS


SUBCLAVIAN STENOSIS POST PTA

Balloon AngioplastySUMMARY

RAPIDLY GROWING FIELD PTCA IDEAL FOR SINGLE VESSEL AND 2-

VESSEL DISEASE WITHOUT PROXIMAL LAD INVOLVEMENT

STENTS USED IN 90% PTCA CASES Drug-eluting stents in 80%

RESTENOSIS LESS OF A LIMITING FACTOR

NON-CORONARY PTA EXPANDING

Mitral Valvuloplasty Aortic Valvuloplasty

Percutaneous Valvuloplasty


MITRAL VALVULOPLASTY

Mitral stenosis

Normal 4-6 cm2

Mild MS 2 cm2

Moderate MS 1.0-1.5 cm2

Severe MS < 1.0 cm2

http://commons.wikimedia.org/wiki/Image:Mitral%20stenosis,%20gross%20pathology%2020G0015%20lores.jpg

MS :PTMC

Wilkin Score-Leaflet mobility-Valvular thickening-Subvalvular thickening-Valvular calcification

Aortic Stenosis:

http://www.pathology.vcu.edu/education/cardio/images/1f-c.jpg

Aortic Stenosis

Recommendations for Aortic Balloon Valvotomy in Adults With Aortic Stenosis

Indication Class

I

A bridge to surgery in hemodynamically unstable patients who are at high risk for AVR

IIa

Palliation in patients with serious comorbid conditions

IIb

Patients who require urgent noncardiac surgery

IIb

As an alternative to AVR IIIBonow et al. 1998 ACC/AHA Task Force

Balloon Aortic Valvuloplasty?

Benefits Yes, but transient

Risks Yes

Alternatives AVR

Alters natural history but also carries risk

Percutaneous AVR ? The future? The only role for BAV ?

BAV in autopsied heart. Note cracks in Ca++ nodules

AS :Percutaneous AV replacement

Percutaneous Aortic Valve Replacement

Percutaneous Aortic Valve Replacement

New TAVI valves are coming to the market in a few year’s time

Boston Sci.Lotus™

HLT

Direct FlowSaint JudePortico™

SymetisACCURATE

JenaValve

MedtronicEngager

EdwardsSapien

MedtronicCoreValve

Next Gen.MedtronicCoreValve

EdwardsSapien XT

EdwardsSapien XT

Today Tomorrow

PS :Percutaneous Balloon pulmonic Valvuloplasty

(PBPV)

Transcatheter Pulmonary Valve Replacement

Bonhoeffer Lancet 2000;356:1403-5

Melody® Valve SapienTM Valve

IDE Trial Began 1/2007

HDE Approval 1/2010

IDE Trial Began 1/08

COMPASSION -Recruiting

Atrial Septal Defect Closure

Atrial septal defect – DevicesAmplatzer Helex

Atrial Septal DefectsAdvantages of

Transcatheter Closure

Fewer Complications Avoidance of Cardioplegia and C-

P bypass Shorter Hospitalization Reduce Need for Blood

Productions Less Patient’s Discomfort

http://www.pathology.vcu.edu/education/cardio/images/1f-c.jpg

Lock Clamshell CardioSEAL

AmplatzerDas Angel Wings

STARFlex

ASDOS Umbrella

Amplatzer ASD Closure Device


Amplatzer Septal Occluder Self-expandable, double disc Nitinol wire mesh, short connecting

waist Discs and waist filled with polyester

fabric

Cera

ASD Closure Device

Amplatzer Septal Occluder

Advantages

Easy deployment

Retrievability prior to complete

deployment

Self-centering defect stenting

mechanism

Single unit construction

Lack of sharp edges (reduces cardiac

perforation)

Can close larger defects with less rim

Easy deployment

Retrievability prior to complete

deployment

Self-centering defect stenting

mechanism

Single unit construction

Lack of sharp edges (reduces cardiac

perforation)

Can close larger defects with less rim


Atrial septal defect – Cribriform device

Transcatheter Closure of ASDsPotential Complications

Device embolization (part or whole

device)

Device migration

TIAs, CVAs (air, thrombus, or device

embol’n)

Perforation of atrium

Atrial arrhythmias

Device encroachment on adjacent

structures

Systemic or pulmonary venous

obstruction

Death from procedure

Anatomic EligibilityLeaflet mal-coaptation resulting

in MR

Non-rheumatic/endocarditic valve morphology; LVIDs ≤55mm; MVA ≥4cm2

Feldman T, Kar S, Rinaldi M, Fail P, Hermiller J, Smalling R, Whitlow PL, Gray W, Low R, Herrmann HC, Lim S, Foster E, Glower D Percutaneous Mitral Repair with the MitraClip System: Safety and Midterm Durability in the Initial EVEREST Cohort

J Am Coll Cardiol 54:686-694, 2009

Central MR – Primary Jet in A2-P2

MitraClip: First-in-class Percutaneous Mitral Valve Repair

SystemClinical evidence demonstrates*:- Superior safety when compared to surgery- Reduction in mitral regurgitation- Favorable left ventricular remodeling- Improvement in patient symptoms- Reduction in hospitalizations for heart failure

The MitraClip:- Establishes vertical coaptation while capturing the

leaflets and drawing them together- Repositionable to allow real-time MR assessment prior to

deployment- Safety and effectiveness are supported by data from the

EVEREST clinical trial program and numerous real-world studies

*N ENGL J MED 2011; 364:1395-1406. MitraClip is subject to prior training requirement as per the Instruction for Use.

Mitral Valve Clip

Clip repair in porcine heart(6 months post repair)

Suture repair in human heart(4 years post repair)

Fann JI, , et al. Beating heart catheter-based-edge-to-edge mitral valve procedure in a porcine model; efficacy and healing response. Circulation 110:988-993, 2004

Privatera et al: Circulation. 2002;106:e173

Mitral Regurgitation Grade

EVEREST II High Surgical Risk Cohort

p < 0.0001

FMRN = 100 Matched Cases

4+4+

4+

4+

3+

3+

3+

3+

2+

2+

2+

2+

1+ 1+

0+

0%

20%

40%

60%

80%

100%

Baseline 1 Year Baseline 1 Year

Perc

ent Pa

tient

s

82%

DMRN = 37 Matched Cases

78%

p = 0.006

WaveCrest: device design

Small 14-20mmMedium 18-25mmLarge 23-30mm

WaveCrest device design

Left atrial appendage closure: WaveCrest

Closure Devices

Femoral Haemostasis

Potential advantages of closure devices: prolonged bed rest

increased comfort reduced cost (LOS)

pain and associated ‘vagal’ reactions Improve use of physician / nurse time complications

Closure devices

Primary IntentionClips and Sutures

Angioseal DuettVasosealAngiolinkOnux

PercloseX-siteSutura Quick seal Sub Q (gel foam)

BioInterventionClo sure PADSyvekFlo sealBiodiscTherus (Ultrasound)

Collagen / thrombin / pads…

Closure devices

Primary IntentionClips and Sutures Collagen / thrombin / pads…

Angioseal DuettVasosealAngiolinkOnux

PercloseX-siteSutura Quick seal Sub Q (gel foam)

BioInterventionClo sure PADSyvekFlo sealBiodiscTherus (ultrasound)

PercloseRedwood City, CA, USA

TechStar 7F - 1 suture

ProStar XL 8F and 10F – 2 sutures

The Closer 6F – 1 suture Knot making tool 3-0 braided polyester (non-absorbable)

Perclose - Closer

Perclose - Closer

Perclose - Closer

Perclose - Closer

Perclose - Closer

AngiosealSt Jude Medical, St. Paul,

Minnesota, USA 6F and 8F devices Components

Biodegradable anchor (intra-arterial) collagen plug (extra-arterial) 3-0 Vycril suture (with clinch knot)

Modifications improved collagen weave pattern mono-fold sheath tip enhanced suture delivery and release

mechanisms re-designed anchor anti-rotation sheath cap Improved indication markings

Angioseal

Angioseal

Angioseal

DuettVascular Solutions Inc.,

Minneapolis, Minnesota, USA

Collagen and thrombin Intra arterial balloon during thrombin

delivery Seals artery and tissue tract Balloon then removed Delivery followed by short period of

manual compression 5F to 9F

Duett

• Insert the Duett catheter into the artery via the existing introducer sheath.

• Inflate the balloon.

• Withdraw the Duett catheter and sheath as a unit until the balloon is positioned firmly against the inner arterial wall.

3F Duett catheter

Existing sheath

Duett

• Deliver the procoagulant directly to the puncture site through the sidearm of the introducer sheath.

• Continue procoagulant delivery until the entire tissue tract is filled.

Duett

• Deflate balloon.

• Remove the Duett catheter and introducer sheath from the patient.

• Maintain direct pressure over the puncture site for 2-5 minutes.

Tissue track also Rx

Puncture site

External Iliac

Profunda femoris Superficial femoral

retroperitoneal haemorrhage

A-V fistulapseudoaneurysmthrombosisvessel laceration

Optimal

Puncture locationSchnyder G Cathet and Cardiovasc Int 2001;53:289

54.5%

% where puncture will be above bifurcation

81.5%

98.5%94.5%

New complications

Skin tract ooze Failed closure Device Infection Arterial obstruction

Interventional cardiology

Documents

intravascular

degenerated

transluminal

side branch

interventional

distal protection

high risk

side branch