Cardiac Resynchronization-Heart Failure study

The CARE-HF (Cardiac Resynchronization-Heart Failure) study was designed specifically to evaluate the effects of CRT on morbidity and mortality (1). This trial was started in January 2001 and was published in April 2005. Eight hundred nineteen patients with EF <35% and evidence dyssyn-chrony were randomized to optimal medical therapy or CRT. Dyssynchrony was defined as either a QRS duration > 150 ms or a QRS duration of 120-149 ms with echocardiographic evidence of dyssynchrony. In the CRT group, there was a 37% risk reduction (p < 0.001) in the primary endpoint, which was a composite of death from any canse or unplanned hospitalization for a major cardiac event (Fig. 11.3). In terms of all-cause mortality (secondary endpoint), there was a 36% risk reduction (p < 0.002) in the CRT group compared to optimal medical therapy. This study went beyond COMPANION by showing that CRT alone, even without the defibrillator, could improve survival. 

A series of pilot studies began with multisite pacing for patients with heart failure and dilated cardiomyopathy in the early 1990s [52, 105-111]. An improvement in LV function and symptoms of heart failure were demonstrated. This provided the interest in biventricular pacing for heart failure. The term cardiac resynchronization therapy was coined to refer to pacing therapies that attempt to enhance cardiac performance by using pacing to correct electrical conduction abnormalities in the heart. The most common form of this therapy is atrial-synchronous... 

Recent studies demonstrate that cardiac resynchronization therapy (CRT) offers a promising approach to selected patients with chronic heart failure. Delayed electrical activation of the left ventricle, characterized on the ECG by a QRS duration that exceeds 120 ms, occurs in approximately one-third of patients with moderate to severe systolic heart failure. Since the left and right ventricles normally activate simultaneously, this delay results in asynchronous contraction of the left and right ventricles, which contributes to the hemodynamic abnormalities of this disorder. Implantation of a speciahzed biventricular pacemaker to restore synchronous activation of the ventricles can improve ventricular contraction and hemodynamics. Recent trials show improvements in exercise capacity, NYHA classification, quality of life, hemodynamic function, and hospitalizations. A device that combined CRT with an implantable cardioverter-defibrillator (ICD) improved survival in addition to functional status. CRT is currently indicated only in NYHA class ni-IV patients receiving optimal medical therapy (ACE inhibitors, diuretics, -blockers, and digoxin) and... 

FIGURE 1.5 Summary of evidence supporting defibrillator implantation as stratified by ejection fraction and heart failure class in patients with ischemic cardiomyopathy (A) and nonischemic cardiomyopathy (B). For details of COMPANION trial, see Chapter 5. (CRT, cardiac resynchronization therapy EPS, electrophysiology study NYHA,New York Heart Association.)... 

Boriani G, Muller CP, Seidl KH, et al. Randomized comparison of simultaneous biventricular stimulation versus optimized interventricular delay in cardiac resynchronization therapy. The Resynchronization for the HemodYnamic Treatment for Heart Failure Management II implantable cardioverter defibrillator (RHYTHM IIICD) study. Am Heart J 2006 151 1050-8. 

Cleland JG, Daubert JC, Erdmann E et al, for the Cardiac Heart Failure (care-HF) Study Investigators (2005) The effect of cardiac resynchronization on morbidity and mortality. N Engl J Med 352 1539-1549... 

Grass D, Leclercq C, Tang AS et al. Cardiac resynchronization therapy in advanced heart failure, the Multicenter Insync clinical study. Fur J Heart Fail 2002 4 311-320. 

Linde C, Gold M, Abraham WT, Daubert JC. Rationale and design of a randomized conUrolled ttial to assess the safety and efficacy of cardiac resynchronization therapy in patients with asymptomatic left ventricular dysfunction with previous symptoms or mild heart failure-the REsynchronization reVErses Remodeling in Systohc left vEntricular dysfunction (REVERSE) study. Am Heart J 2006 151 288-94. 

Abraham WT, Fisher WG, Smith AL, et al for the MIRACLE Study Group. Cardiac resynchronization in chronic heart failure. N EnglJ Med 2002 346 1845-1853. 

---