Cardiac Devices CRT,ICD: Who is and is not a Candidate? Who Decides

Cardiac Devices CRT,ICD: Who is and is not a Candidate? Who Decides Colette Seifer MB(Hons) FRCP(UK) Associate Professor, University of Manitoba, Cardiologist, Cardiac Sciences Program, St Boniface Hospital

Disclosures No disclosures

Objectives List the main indications for CRT, ICD Describe the limitations of CRT, ICD Assess the suitability of patients for CRT,ICD Decide who should receive CRT,ICD

Case 62 yo male Ischemic cardiomyopathy LVEF 20% Surgical revascularization > months ago Optimal pharmacotherapy NYHA functional class III ECG

Case Is he a good candidate for CRT? 1. Yes 2. No

Case 82 yo male Nonischemic cardiomyopathy LVEF 30% Optimal pharmacotherapy for 9 months NYHA functional class III ECG

Case His a good candidate for CRT? 1. Yes 2. No

The Evidence IN-SYNC PACE 1998;21:2249 PATH CHF Am J Card 1999;83:130-5 MUSTIC NEJM 2001;344:873-80 MIRACLE NEJM 2002;346:1845-53 COMPANION NEJM 2004;350:2140-50 CARE-HF NEJM 2005;352:1539-49 MADIT-CRT NEJM 2009;361:1329-38 RAFT NEJM 2010;363:2385-95

The Evidence IN-SYNC PACE 1998;21:2249 Early small trials, suggested technically feasible and patients demonstrated benefit including: PATH CHF Am J Card 1999;83:130-5 Improved ventricular function Improved exercise tolerance MUSTIC NEJM Improved 2001;344:873-80 quality of life Reduced hospitalizations MIRACLE NEJM 2002;346:1845-53 COMPANION NEJM 2004;350:2140-50 CARE-HF NEJM 2005;352:1539-49 MADIT-CRT NEJM 2009;361:1329-38 RAFT NEJM 2010;363:2385-95

CRT Cardiac Resynchronization Therapy 25-33% of CHF patients have some form of intraventricular conduction delay (increased QRS duration on ECG) Most common delay is LBBB In LBBB, electrical activation of the lateral aspect of the left ventricle delayed in relation to the right ventricle and interventricular septum

CRT Electrical dyssynchrony (ED) can result in mechanical dyssynchrony This, in turn, leads to mechanical inefficiency Resynchronization (biventricular pacing), involves coordinating contraction between LV & RV Lead placed in RV and LV

Post CRT

CRT Clinical improvement reported in up to 60-70% of patients 1 Remaining ~30% non-responders We now know that ED does not inevitably result in mechanical dyssynchrony (MD) 1 Eur J of Heart Failure (2013) 15, 1419 28

Age 64 (68% were male) Patients had NYHA Class III(90%) or IV Medications doses stable for 1 month Ischemic (~50%) or nonischemic, EF <35% LVEDD >55 mm QRS > 130 ms (mean 168 ms) 6 minute walk test <450 m (~300 m) Atrial fib excluded from trial Miracle Trial

MIRACLE Study Design 453 patients enrolled Double blind Cross-over Design All patients received a CRT (no ICD) 50% had device turned off for 6 months After 6 months, groups were reversed Device implanter not involved in patient follow-up N Engl J Med 2002;346:1845-53

MIRACLE - Results NYHA Class Improved by 2 classes 6% control 16% CRT Improved by 1 class 32% control 52% CRT Quality of Life Markedly improved 12% control 38% CRT Mod/slightly improved 45% control 41% CRT 6 minute walk test Median (m) +10m control +39m CRT N Engl J Med 2002;346:1845-53

MIRACLE - Results N Engl J Med 2002;346:1845-53

Medical therapy vs CRT vs CRT with ICD Ischemic (55%) or Nonischemic 68 yrs (69% male) Class III (84%) or IV EF <35% (mean 20%) QRS >120 (160 ms) (70%LBBB, 10% RBBB) Sinus rhythm Companion Trial

NYHA class III LVEF 20% QRS 160 ms LBBB 68% beta blocker use N Engl J Med 2004;350:2140-50

Companion - Results (All cause death or any hospitalization) 56% 56% 68% N Engl J Med 2004;350:2140-50

Companion - Results (All cause death) (12%) (19%) (15%) N Engl J Med 2004;350:2140-50

NYHA Class III or IV Med therapy vs Med therapy + CRT End-point combined death and hospitalization EF <35% QRS of >120 ms (if b/w 120 and 149, needed echo evidence of mechanical dyssynchrony) Excluded if atrial arrhythmias CARE-HF

CARE-HF N Engl J Med 2005;352:1539-49

Summary Miracle, Companion, CARE-HF NYHA Class III EF <35% QRS >120-130ms CRT reduces hospitalizations and mortality vs standard medical therapy CRT-D reduces all cause mortality

N Engl J Med 2009;361:1329-38 1820 patients NYHA class I-II QRS >130ms LVEF < 30% ICD vs CRT-D MADIT-CRT

MADIT-CRT - results N Engl J Med 2009;361:1329-38

1798 patients NYHA Class II-III LVEF < 30% QRS > 120 ms ICD vs CRT-D RAFT

RAFT - results N Engl J Med 2010;363:2385-95

Summary - CRT Who benefits? NYHA Functional Class II-III Optimal medical management of heart failure, including, where appropriate, revascularization QRS >150 ms LBBB Sinus rhythm LVEF <30% (?>20%)

CRT 1 Eur J of Heart Failure (2013) 15, 1419 28

Guidelines

ICD s Eur Heart J 2000;21:2071 2078

1232 patients Prior MI >1 month LVEF <30% Fixed defect/akinesis/obstructive CAD MADIT-II

MADIT II - results N Engl J Med 2002;346:877-83

2521 patients LVEF <35% Ischemic or nonischemic NYHA class II-III Standard care vs Amiodarone vs ICD SCD-HeFT

SCD-HeFT - results N Engl J Med 2005;352:225-37

Other trials.. DINAMIT (N Engl J Med 2004;351:2481-8) ICD vs no ICD in patients with EF <35% and 6-40 days post MI No difference in all-cause mortality (mean 2 year follow-up) CABG-PATCH (N Engl J Med 1997; 337:1569 1575) ICD vs no ICD in patients with EF 35% at the time of CABG No difference in all-cause mortality Definite (N Engl J Med 2004;350:2151-8) ICD vs no ICD in patients with nonischemic cardiomyopathy, EF 35% Reduction in arrhythmic death but not in all-cause mortality

Guidelines Can J Cardiol 2005;21(suppl A) 11A-18A

Guidelines

Other factors Severe right ventricular dysfunction Outside guidelines, transplant candidates Renal failure Atrial fibrillation Upgrading (eg ICD to CRT) CRT-D vs CRT-P

Who should decide? Familiar with the evidence and guidelines Need to be familiar with the procedure including risks (and benefits) Need a working understanding of programming and follow-up of devices Need to follow-up patients Great opportunity for collaboration

Who should decide? 1500 patients Randomized to 3 different programming configurations for therapy 1.5 year follow-up Programming of ICD therapies for tachyarrhythmias of 200 beats per minute or higher or with a prolonged delay in therapy at 170 beats per minute or higher, as compared with conventional programming, reduced mortality and inappropriate therapy MADIT-RIT

Who should decide? J Am Coll Cardiol 2009;53:765 73

Who should decide?

Cost

Conclusion The evidence presented supports improved symptoms and survival for subgroups of patients with cardiovascular disease Patients should be carefully selected after considering benefits and risks Follow-up is required to ensure maximum benefit

Who should decide?