Nearly one-fifth of patients with acute heart failure who receive implantable cardioverter defibrillators and cardiac resynchronization devices are at least 80 years old, even though most clinical trials of the devices' safety and effectiveness excluded this age group, according to a report in the Archives of Internal Medicine.
Procedure-related complications are more frequent in elderly than in younger patients, and in-hospital mortality is higher. These findings indicate that additional studies are needed “to clarify the appropriateness of device implantation in older patients with heart failure, as well as the merits of less invasive options,” said Jason P. Swindle of the Center for Outcomes Research at Saint Louis University, and his associates.
The investigators studied age-specific practices in the placement of ICDs and cardiac resynchronization therapy (CRT) because “few data exist on outcomes in older patients, as pivotal device trials have generally enrolled a young cohort of patients relative to those observed in the clinical setting.”
Using a national database comprising several hundred hospitals and health care systems, they assessed the records of 26,887 adults admitted to acute care hospitals for heart failure in 2004–2006 who received an implantable cardiac device. The median patient age was 70 years, markedly older than the median ages of 58–67 years in major clinical trials.
About half of the patients received ICDs, 44% of patients received CRT with defibrillators, and the remainder received CRT without defibrillators.
A total of 17.5% (4,694) of these patients were aged 80 or older; of those, 6.6% (309) were 89 years and older.
In-hospital mortality was significantly higher in patients older than 85 (2.2%) and in those aged 80–85 (1.2%), compared with younger patients (0.7%), Mr. Swindle and his colleagues wrote (Arch. Intern. Med. 2010;170:631-7).
Advanced age also was associated with increased length of stay and higher total costs of hospitalization.
This study was not designed to assess longer-term outcomes such as 30-day or 1-year mortality, nor could it address other outcomes such as readmission rates or quality of life issues, they noted.
In an accompanying editorial, Dr. Fred Kusumoto of the Mayo Clinic, Jacksonville, Fla., said that these findings confirm that patients who receive cardiac devices in actual practice vary significantly from the study subjects in whom the devices were initially tested. “It is imperative that future trial design considers the broad diversity of the U.S. population,” he noted.
More importantly, “we must recognize the shortcomings of our current knowledge and how that affects individual decision making,” Dr. Kusumoto said (Arch. Intern. Med. 2010;170:638-9).
“For ICD implantation, each patient will have different questions and varying clinical benefit. It is important for each of us to understand the medical issues, take our own personal biases into account, and honor our patient's wishes,” he said.
The study was funded in part by the National Institutes of Health. Neither Mr. Swindle nor Dr. Kusumoto reported any financial conflicts of interest.
The average age of ICD and CRT patients is higher than that in clinical trials.