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FOCUS ON CARDIOVASCULAR DISORDERS     Omar Badawi, Section Advisor

Cardiac resynchronization therapy for patients with asymptomatic mild heart failure

Key point: Results from a large trial involving more than 1,800 patients with New York Heart Association (NYHA) Class I or II heart failure showed that patients randomized to cardiac resynchronization therapy (CRT) defibrillators had a 34% relative reduction in the risk of all-cause mortality or first heart failure event compared with patients who received a standard implantable cardioverter defibrillator (ICD).

Finer points: The results of MADIT-CRT (Multicenter Automatic Defibrillator Implantation Trial with Cardiac Resynchronization Therapy) were simultaneously presented at the 2009 European Society of Cardiology Congress in Barcelona and published in the New England Journal of Medicine. Patients with ischemic or nonischemic NYHA Class I or II heart failure with an ejection fraction of 30% or less and a wide QRS complex (130 ms or more) were randomized in a 3:2 ratio to CRT with an ICD (CRT–ICD, n = 1,089) or a standard ICD (n = 731). Death from any cause or nonfatal heart failure events was assessed as the primary endpoint.

Baseline demographic characteristics were similar between the two groups; patients had a mean age of 64.5 years, 75% were male, 90% were white, and approximately 55% of patients in both groups had ischemic heart disease. After a mean duration of 2.4 years, the primary endpoint occurred in 17.2% of patients in the CRT–ICD group compared with 25.3% of patients in the standard ICD group (hazard ratio [HR] 0.66 [95% CI 0.52–.84], P = 0.001). This significant difference was driven by a reduction in heart failure events in the CRT–ICD group (13.9% vs. 22.8%, HR 0.59 [0.41–0.74], P < 0.001) that was primarily noted in patients with a QRS duration of 150 ms or more. Death from any cause occurred at a similar rate in the two groups (6.8% for CRT–ICD vs. 7.3% for standard ICD), and similar results were observed for patients with ischemic and nonischemic heart failure. The investigators also reported that left ventricular volume was reduced, and that the ejection fraction was increased to a significantly greater degree, in patients in the CRT–ICD group. Serious adverse events occurred with similar frequency in the two groups.

What you need to know: In 2008, the American College of Cardiology/American Heart Association in collaboration with the American Association for Thoracic Surgery and Society of Thoracic Surgeons published guidelines on the use of implantable devices. These guidelines recommend that CRT–ICDs be used in patients with NYHA Class III or IV heart failure who have an ejection fraction of 35% or less and a QRS duration of 120 ms or more. The results of the current trial may be used to support the expanded use of CRT–ICDs for certain patients with NYHA Class I or II heart failure. In an accompanying editorial, Mariell Jessup, MD, pointed out that based on the results of MADIT-CRT, 12 patients would need to be treated to prevent a single heart failure event without a mortality benefit. Jessup recommended that any expanded indication for a CRT–ICD in patients with NYHA Class I or II heart failure be limited to patients with “a QRS duration of more than 150 ms in whom marked symptoms have been controlled with optimal medical therapy,” given the cost of this intervention and lack of mortality benefit.

What your patients need to know: Educate patients with asymptomatic to mild heart failure that a new study shows that CRT–ICD reduces heart failure events and appears to slow the progression of the disease but showed no effect on mortality. Patients interested in CRT–ICDs should consult their cardiologists to determine if they are candidates.

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