Morbidity High For Older Patients With Secondary-Prevention ICD

Larry Hand

January 30, 2017

AURORA, CO — Almost 80% of older patients who received an implantable cardioverter defibrillator (ICD) for secondary prevention after being resuscitated for cardiac arrest lived at least 2 years afterward, according to new research[1].

However, more than 65% of the patients required hospitalization within 2 years, and many others required admission to a skilled nursing facility, according to researchers.

"This isn't a study of the effectiveness of ICD therapy, because there was no group that wasn't treated for comparison, but it still allows us to understand how these patients fare in today's clinical practice," senior author Dr Frederick A Masoudi (University of Colorado, Aurora) told heartwire from Medscape. "It also provides a perspective on the healthcare needs in these patients after ICD implantations, specifically related to subsequent hospitalizations and the need for skilled nursing facilities."

The study "provides insight into the outcomes of this patient population that's not been well studied and for which it's really been a blank slate to this point," he continued. "It illustrates the value of national registry programs in generating clinically germane data that otherwise would not be available."

He and his colleagues conducted an analysis of data on 12,420 Medicare beneficiaries from the National Cardiovascular Data ICD Registry who underwent first-time ICD implantation for secondary prevention between 2006 and 2009 at 956 US hospitals.

Although all patients receiving an ICD for primary prevention—prior to experiencing cardiac arrest—are required to be entered into the database, 91% of participating hospitals also submitted information on patients who received an ICD for secondary prevention.

The study group consisted of patients 65 years and older who were mostly white (91%) and in whom ischemic heart disease was common (75%). More than 40% had left ventricular ejection fraction over 35%, according to an article published January 24, 2017 in the Journal of the American College of Cardiology.

Researchers found the overall death rate at 2 years to be 21.8%, ranging from 14.7% in patients 65 to 69 years old to 28.9% in patients at least 80 years old. In a multivariable analysis, the risk ratio of death at 2 years for patients at least 80 years old was 2.01 (95% CI 1.85–2.33, P<0.001).

They found the overall cumulative incidence of hospitalization at 2 years for any cause to be 65.4%, ranging from 60.5% for people 65 to 69 years old to 71.5% for people at least 80 years old.

The overall cumulative incidence of admission to a skilled nursing facility at 2 years was 13.1% for patients 65 to 69 years old, compared with 31.9% for patients at least 80 years old, an adjusted hazard ratio of 2.67 (95% CI 2.37–3.01, P<0.001).

"The one thing I found that was particularly interesting was the survival rate at 2 years, which compared very favorably to the survival rates of patients getting secondary-prevention devices in the clinical trials," Masoudi noted.

This likely reflects the evolution of medical therapy for underlying structural heart disease, he said. "But I think it also reflects the patient selection being applied in practice and the fact that physicians and their patients are applying thoughtfulness in deciding whether or not to proceed with the secondary-prevention defibrillator."

"I think there are a number of people for whom prolongation of life is an objective, even among older people. In those people, considering an ICD may be a very reasonable thing to do," he said.

"The existing studies upon which we based our understanding of outcomes of treated patients who received secondary-prevention ICDs were derived from clinical trials many years ago and predate much of the evidence-based therapy for structural heart disease that we now currently employ, as well as many of the technological advances that have occurred with ICD therapy," Masoudi said.

The researchers write that this is the first study to assess admission to skilled nursing facilities, an outcome particularly relevant to older patients.

In an accompanying editorial[2], Dr Sumeet S Chugh (Heart Institute, Cedars-Sinai Medical Center, Los Angeles, CA) and colleagues write that deciding whether an older patient gets a secondary-prevention ICD "has evolved into a difficult and complex decision for the clinical cardiologist, patient, and caregivers."

The issues could be resolved by running a clinical trial among a population of elderly patients at risk, they wrote.

"In the meantime," they concluded, "clinicians should consider noncardiac comorbidities and frailty along with age in their decision-making process; provide the patient with a clear understanding of the rationale and limitations of the ICD; and encourage advance directives and bring up the possibility of deactivating the ICD if the patient is nearing end of life."

Masoudi reported that he is chief science officer for the National Cardiovascular Data Registries. Disclosures for the coauthors are listed in the paper.

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