Cardiac Resynchronization Therapy (CRT) Is an Effective Treatment for Heart Failure and Indications...

Cardiac Resynchronization Therapy (CRT) Is an Effective Treatment for Heart Failure and Indications Are Expanding

Multiple trials have shown the clinical value of CRT: decreased mortality, improved quality of life, and reduced hospitalizations.1-5

Today, more patients than ever are available to receive a CRT device and benefit from this therapy.

1 Cleland JG, et al. N Engl J Med. 2005;352:1539-1549. 2 Cleland JG, et al. Eur Heart J. 2006;27:1928-1932.

3 Bristow MR, et al. J Card Fail. 2000;6:276-285.4 Abraham WT, et al. N Engl J Med. 2002;346:1845-1853. 5 Young JB, et al. JAMA. 2003;289:2685-2694. 1

郭航远绍兴市人民医院

MortalityHF or CV

HospitalizationsCardiac Function/

StructureQoL or NYHA

CARE-HF1,2 + + + NA

COMPANION3 + + NA NA

MIRACLE4 NA NA + +

MIRACLE ICD5 NA NA NA +

REVERSE6 NA +* + =

RAFT7 + + NA NA

MADIT CRT8 +* + +* NA

CRT Is Highly Beneficial1-8

CRT is an effective treatment for heart failure patients with:

• systolic dysfunction • ventricular electrical conduction delays

1 Cleland J, et al. N Engl J Med. 2005;352:1539-1549.2 Cleland J, et al. Eur Heart J. 2006;27:1928-1932.3 Bristow M, et al. J Card Fail. 2000;6:276-285.4 Abraham W, et al. N Engl J Med. 2002;346:1845-1853.

5 Young J, et al. JAMA. 2003;289:2685-2694.6 Linde C, et al. JACC. 2008;52:1834-1843. 7 Tang A, et al. N Engl J Med. 2010;363:2385-2395. 8 Moss A, et al. N Engl J Med. 2009;361:1329-1338.

NA = Not powered, not collected, or not blinded for specific end point. * Post-hoc analysis.

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Number of Patients Receiving CRT May Increase in Coming Years Due to:• Expansion of indications for CRT-D devices to NYHA Class II1-3*

• Under-penetration of current NYHA Class III/IV indications4,5

1 Tracy CM, et al. Circulation. 2012;126:1784-1800.2 Tang AS, et al. N Engl J Med. 2010;363:2385-2395.

* Indications for CRT-D devices include "Left bundle branch block (LBBB) with a QRS duration ≥ 130 ms, left ventricular ejection fraction ≤ 30%, and NYHA Functional Class II"

3 Linde C, et al. J Am Coll Cardiol. 2008;52:1834-1843.4 Epstein AE, et al. Circulation. 2008;117:e350-e408.5 Fonarow GC, et al. Circ Heart Fail. 2008;1:98-106. 3

Current Challenges with CRT

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Unpredictable CRTImplant Times

Unpredictable CRTImplant Times

CRT ChallengesCRT Challenges

Suboptimal CRT ResponseSuboptimal CRT Response

Clinical & Economic Need:CRT Implants Are Complex and Time-Consuming

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Initial CRT Device Implants (N=870)1

1 PPDA Q3FY12/Q4FY12/Q1FY13/Q2FY13 - (Waves 1-4): Economic Considerations for CRT Implants

Clinical & Economic Need:Placing the LV Lead Is Time-Consuming

1 PPDA Q4FY12/Q1FY13 - (Waves 2 and 3): Economic Considerations for CRT Implants.2 Bax JJ, et al. J Am Coll Cardiol. 2005;46:2168-2182. 6

Current Challenges with CRT

7

Unpredictable CRTImplant Times

Unpredictable CRTImplant Times

CRT ChallengesCRT Challenges

Suboptimal CRT ResponseSuboptimal CRT Response

Up to 1/3 of Patients Do Not Experience the Full Benefits of CRT

* AV optimized only

67%

58%

67%

MIRACLE1 MIRACLE MIRACLE II InSync III PROSPECT5 FREEDOM6

ICD2 ICD3 Marquis4™*

100%

67% 69%

52%

90%

80%

70%

60%

50%

40%

30%

20%

10%

0%

% Im

pro

ved

Clin

ical

Co

mp

osi

te S

core

1 Abraham WT, et al. N Engl J Med. 2002;346:1845-1853. 2 Young JB, et al. JAMA. 2003;289:2685-2694.3 Abraham WT, et al. Circulation 2004;110:2864-2868.

4 Chung ES, et al. Circulation. 2008;117:2608-2616.5 van Gelder BM, et al. J Cardiovasc Electrophysiol. 2008;19:939-944.6 Abraham WT, et al. Late-Breaking Clinical Trials, HRS 2010. Denver, Colorado. 8

There Are Many Drivers for CRT Non-Response1

Achieving maximum CRT response requires a multi-disciplinary approach

Potential Reasons for Suboptimal CRT Response

Per

cent

age

of N

onre

spon

der

Pat

ient

s w

ith T

hese

Fin

ding

s

Mullens W, et al. JACC. 2009;53:765-773.

SuboptimalAV Timing

Arrhythmia Anemia SuboptimalLV LeadPosition

< 90%Biventricular

Pacing

SuboptimalMedicalTherapy

PersistentMechanical

Dyssynchrony

UnderlyingNarrowQRS

ComplianceIssues

Primary RVDysfunction

50%

45%

40%

35%

30%

25%

20%

15%

10%

5%

0%

1 Mullens W, et al. J Am Coll Cardiol. 2009;53:765-773. 9

Economic Impact

1 Cost information from 2010 Premier hospital database analyzing 108,982 Inpatient Heart Failure Admissions (Abstract Submission to ISPOR and AHA QCOE, to be presented in July 2013).

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Unpredictable CRT

Implant Times

Unpredictable CRT

Implant Times

CRT ChallengesCRT Challenges

Suboptimal CRT Response

Suboptimal CRT Response

Real-Time Navigation for CRT Implants

The CardioGuide™ Implant System Provides a SolutionThe CardioGuide Implant System – the first real-time navigation system for CRT implants – uses computer technologies to guide implanters in optimal LV lead placement.

The system generates 3D images of coronary vessels to help clinicians:

• Find appropriate LV lead locations

• Identify proper lead delivery tools

• Confirm final lead position

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12

12

Obtain 3D model automatically

Shoot 2+ venograms

Trace veins of interest on both venograms

Understand and Examine Vein Anatomy

CardioGuide 3D System: Optimize LV Lead Implant

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Navigate real-time in fluoroSelect preferred target site and choose LV lead

Obtain anatomical information about target & match best lead Detect where lead is & how far from target

CardioGuide 3D System: Optimize LV Lead Implant

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CardioGuide M-Map System: Drive for Full Benefit of CRT

Identify latest site(s) of mechanical activation

Obtain contraction timing maps along veins

Select most appropriate delayed site and choose LV lead

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Drive for Full Benefit of CRT

• Helping clinicians choose the proper lead location and providing confirmation of final lead position may impact CRT procedure efficiency and the economic welfare of the hospital.1-4

1 Giannola G, et al. Europace. 2011;13:244-250.2 Khan FZ, et al. Europace. 2011;13:845-852.

3 Khan FZ, et al. J Am Coll Cardiol. 2012;59:1509-1518.4 Prinzen FW, et al. J Cardiovasc Transl Res. 2012;5:188-195. 16

Thank You

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