"Cardiac-Resynchronization Therapy in Heart Failure with QRS Complex".The New England Journal of Medicine. 2010. 363(25):2385-2395.
Links to original sources: Wiki Journal Post Full Journal Article
In patients with NYHA class II or III heart failure, left ventricular systolic dysfunction, and a wide QRS complex, does the addition of CRT to an ICD and optimal medical therapy improve outcomes?
In patients with NYHA class II or III heart failure, adding CRT to an ICD and optimal medical therapy reduced rates of death and hospitalization for heart failure but was accompanied by more adverse events.
CRT has been shown to benefit patients with advanced heart failure, but studies had not examined its role in patients with milder symptoms who were already treated with an ICD and optimal medical therapy. The RAFT trial found that CRT, when added to an ICD and optimal medical therapy, reduced the composite outcome of death from any cause and hospitalization for heart failure, as well as all-cause mortality, in patients with NYHA class II or III heart failure.
As of 2010, there were no established guidelines reflecting the results of this trial. It is likely subsequent guidelines will incorporate these findings.
Multicenter, double-blind, randomized, controlled trial.
Inclusion Criteria: - NYHA class II or III heart failure - Left ventricular ejection fraction ≤30% - Intrinsic QRS duration ≥120 msec or paced QRS duration ≥200 msec
Exclusion Criteria: - Major coexisting illness or recent cardiovascular event
- ICD alone (n=904) - ICD with CRT (n=894)
Primary Outcome: Death from any cause or hospitalization for heart failure. Secondary Outcomes: Death from any cause at any time, death from cardiovascular cause, hospitalization for heart failure, subgroup analyses based on NYHA class.
- Higher rate of adverse events associated with device implantation in the CRT group suggests that implantation and follow-up care require careful consideration.
Canadian Institutes of Health Research and Medtronic of Canada. Medtronic provided funding and CRT components but was not involved in trial conduct or reporting.
Detailed protocol and statistical analysis plan can be found by visiting NEJM.org and searching for the article or its ClinicalTrials.gov number, NCT00251251.