New research based on data from the ICD Registry and Get With The Guidelines–Heart Failure shows higher rates of survival after three years for a group of patients hospitalized with heart failure with an left ventricular ejection fraction (LVEF) of 35 percent or less who received a prophylactic implantable cardioverter defibrillator (ICD), when compared to no ICD. Although ICDs are indicated for patients with an LVEF between 30 and 35 percent, prior to the research, uncertainties remained about the survival benefit associated with the use of prophylactic ICDs in patients with an LVEF of less than 30 percent.

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The research was published June 3 in the Journal of the American Medical Association, and analyzed data from the ICD Registry and the Get With The Guidelines–Heart Failure database. The authors looked at three-year outcomes for 3,120 Medicare beneficiaries with an LVEF between 30 percent and 35 percent who received an ICD during a hospitalization for heart failure. The analysis was repeated in 4,578 patients with an LVEF of less than 30 percent.

Results showed that among the patients with an LVEF between 30 and 35 percent, risk of all-cause mortality was significantly lower in patients who received a prophylactic ICD than in comparable patients with no ICD (3-year mortality rates: 51.4 vs 55.0 percent). Presence of an ICD was also associated with better survival in patients with an LVEF of less than 30 percent (3-year mortality rates: 45.0 vs 57.6 percent).

Although the difference in risk found was not large (3.6 percent at 3 years), the authors note the significance of the findings. "These results support guideline recommendations to implant a prophylactic ICD in eligible patients with an LVEF of 35 percent or less."

"Although most of the randomized clinical trials of prophylactic ICDs required an LVEF of ≤35 percent for enrollment, the median LVEF of enrolled patients was well below 30 percent," said lead author Sana Al-Khatib, MD, MHS, FACC. "Because a large number of prophylactic ICDs in the U.S. are implanted in patients with an LVEF between 30 percent and 35 percent, understanding outcomes associated with the ICD in such patients is important."

The authors note that moving forward, looking at other end points, such as quality of life, may also be of value to patients. "Information on such end points as well as on procedural complications is crucial for clinical decision making. Although we were not able to examine other end points in our study, our research may provide the impetus for studying these end points in future trials," they add.

Keywords: Risk, Registries, Quality of Life, Survival Rate, Heart Failure, Stroke Volume, Medicare, Defibrillators, Implantable, National Cardiovascular Data Registries, ICD Registry

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