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FDA approves expanded indication for cardiac resynchronization therapy
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Medtronic announced today that the FDA approved an expanded indication for its cardiac resynchronization therapy with implantable cardioverter defibrillator devices. With this indication, therapy can be used earlier in a mildly symptomatic HF patient population.
The expanded indication includes patients with NYHA Class II HF with left ventricular ejection fraction of ≤30%; left bundle branch block; and a QRS ≥130 ms. Medtronic CRT-D devices were previously indicated to treat certain patients with moderate-to-severe HF (NYHA Class III and IV).
The FDA decision for expanded indication was based on data from the REVERSE and RAFT clinical trials, which showed that CRT-D can benefit mildly symptomatic HF patients by reducing mortality and HF hospitalization rates. In the RAFT trial, CRT-D reduced mortality by 29% for mildly symptomatic HF patients compared with patients treated with guideline-recommended ICDs and medical therapy (P=.006). Therapy also reduced combined mortality and HF hospitalization for this patient population (27%; P=.001). The REVERSE trial evaluated the impact of CRT in patients with mild HF, with or without symptoms; all participants received a score of improved, unchanged or worsened. During the study, 21% of patients without CRT worsened vs. 16% of patients with CRT (P=.10). In addition, analysis showed that CRT was associated with improvement in cardiac structure and function as measured by echocardiography; delays in the time to first HF hospitalization; and an overall reduction of HF hospitalization or all-cause death.
“The RAFT and REVERSE study findings provide strong clinical evidence validating the safety, efficacy and lifesaving benefits of CRT-D for treating systolic HF patients with milder symptoms,” Michael R. Gold, MD, PhD, REVERSE study investigator and director of cardiology at the Medical University of South Carolina, said in a press release. “This expanded indication fulfills an unmet need by treating these patients in the earlier stages of heart failure, before their symptoms more significantly impact their quality of life.”
Medtronic will conduct a post-approval study to further substantiate the clinical benefits of CRT-D treatment in the Class II HF patient population, according to the press release.
Nearly 200,000 Americans are considered NYHA Class II, with another 620,000 people worldwide fitting this designation.