Age alone may be insufficient reason to withhold transcatheter aortic valve replacement (TAVR) in nonagenarians, a study suggested.
Recipients age 90 and older did have higher odds of 30-day mortality (8.8% versus 5.9% in younger individuals, hazard ratio 1.46, 95% CI 1.25-1.71) and 1-year mortality (24.8% versus 22.0%, HR 1.20, 95% CI).
But they also had a higher Society of Thoracic Surgeons Predicted Risk of Operative Mortality Score to begin with (10.9% versus 8.1%, P<0.001), , of Heart Hospital Baylor Plano in Texas, and colleagues reported online in the Journal of the American College of Cardiology
Thus, (observed-to-expected ratio 0.81, 95% confidence interval CI 0.70-0.92), similar to TAVR in the younger population (0.72, 95% CI 0.67-0.78).
Although the elderly group had worse quality of life scores at 30 days (70.8 versus 72.9 on the Kansas City Cardiomyopathy Questionnaire scale, P=0.006), this disadvantage disappeared by 1 year (79.2 versus 81.3, P=0.539).
"These findings suggest that nonagenarians likely recover more slowly after TAVR and thus need more time until the beneficial effect of the procedure is measurable," the investigators wrote. "Although the 30-day and 1-year mortality rates were statistically higher compared with younger patients undergoing TAVR, the absolute and relative differences were clinically modest."
"These data support safety and efficacy of TAVR in select very elderly patients," they concluded. "TAVR should not be denied solely on the basis of patient age."
, of the Christiana Care Health System in Newark, Del., agreed that the decision should be personalized for each elderly individual.
"The patient's health status, as well as the desires of the patient and family, should be paramount in the decision as to whether to proceed," he wrote in an accompanying editorial.
Mack and colleagues' investigation included 24,025 patients who underwent TAVR between 2011 and 2014. Data was collected by the TVT Registry, with long-term outcomes linked by Medicare administrative claims.
Among the patients, 15.7% were age 90 and above. This group held no disadvantage in stroke, aortic valve reintervention, or myocardial infarction at 30 days or 1 year.
The researchers emphasized that "nonagenarians who are currently undergoing TAVR represent a highly selected group," citing lower rates of reduced ejection fraction, prior cardiac surgery, and prior stroke in this cohort.
And because the TVT Registry only captured procedures with commercially-approved devices, the authors acknowledged that their data do not represent "an all-comers population or the most recent iterations of transcatheter devices." There was also a marked group of patients with missing follow-up data which may have skewed the results, they suggested.
Weintraub nevertheless maintained that the data "clearly established" that TAVR can be done in select nonagenarians.
But better than asking can it be done is to ask should it be done, the editorialist suggested.
"One place to look for guidance is to the published cost-effectiveness data," he wrote. Results from the PARTNER cohort B study suggested that the initial high costs of TAVR were were offset by large gains in life expectancy for a population with an average age in the early 80s.
In nonagenarians, however, he noted that "there is reason to be concerned that TAVR may exceed a societal willingness-to-pay threshold of perhaps $100,000 or even $150,000 per quality-adjusted life-year gained."
But, "we still do not have sufficient experience to reliably identify those patients most likely to benefit, so firm standards for withholding TAVR from nonagenarians are not, at this time, appropriate," he concluded.
"Although there may be a societal decision to withhold such care for patients over a certain age, the caregivers' responsibility in making the decision as to whether to proceed is to the patient and the patient's family."
Disclosures
Mack disclosed serving, without compensation, on the executive committee of the PARTNER trial of Edwards Lifesciences.
Weintraub reported no relevant conflicts of interest.
Primary Source
Journal of the American College of Cardiology
Arsalan M, et al "Should transcatheter aortic valve replacement be performed in nonagenarians? Insights from the STS/ACC TVT Registry" J Am Coll Cardiol 2016; DOI: 10.1016/j.jacc.2016.01.055.
Secondary Source
Journal of the American College of Cardiology
Weintraub WS "TAVR in nonagenarians: pushing the boundaries" J Am Coll Cardiol 2016; DOI: 10.1016/j.jacc.2016.01.054.