Study Suggests Patient Age of 90 Years or More Should Not Preclude TAVR

Aside from having a higher rate of minor vascular complications, patients who are at least 90 years old at the time of balloon-expandable TAVR fare just as well as their younger counterparts, according to a study published online July 15, 2015, ahead of print in the American Journal of Cardiology. Age was not a predictor of all-cause mortality through 2 years of follow-up.

“Advanced age, in the absence of significant comorbidities, should not deter clinicians from offering TAVR for patients with severe aortic stenosis,” study coauthor Yigal Abramowitz, MD, of Cedars-Sinai Heart Institute (Los Angeles, CA), told TCTMD in an email.

“Clinicians should be aware that sometimes age is just a number,” he said. “Decision making for advanced age patients should be based on a thorough clinical evaluation taking into account each patient’s aspirations and wishes.”

The researchers looked at data on 734 patients who underwent TAVR at their center between April 2012 and December 2014. Overall, 18.5% of patients were at least 90 years old at the time of the procedure (mean age 92.4 years); the mean age of the younger patients was 79.7 years.

All patients had congestive heart failure with NYHA class II-IV symptoms and underwent the procedure under general anesthesia. Balloon-expandable Sapien, Sapien XT, or Sapien 3 valves (Edwards Lifesciences) were used in all cases, mostly delivered transfemorally (85.3%). Access was transaortic in 8.3%, transapical in 5.6%, and subclavian in 0.8%.

There were substantial differences in baseline characteristics, as older patients were less likely to have diabetes, CAD, PAD, chronic lung disease, and a history of CABG or valve surgery. They were more likely to be frail and to have chronic renal failure, A-fib, and a permanent pacemaker. Body mass index was lower in older patients.

Procedural, Clinical Outcomes Similar Across Age Groups

Older patients were more likely to receive first-generation Sapien valves instead of Sapien XT or Sapien 3 valves and to undergo transfemoral TAVR, but device success was 96% in both the younger and older cohorts. After the procedure, TEE paravalvular leak grades and mean aortic valve gradients did not differ between groups.

Mean hospital stay was about 5 days in both groups (P = .67). By 30 days, mean NYHA class was similar in the older and younger patients (1.84 vs 1.71; P = .11).

At 30 days, minor vascular complications were more frequent in nonagenarians, but there were no between-group differences in all-cause mortality or other clinical outcomes (table 1).

All-cause mortality remained similar in both age groups at 1 year (12.5% vs 12.3%; P = .75), with no difference in survival through 24 months of follow-up (P = .07).

On multivariate analysis, an age of 90 years or older was not associated with all-cause mortality (HR 0.93; 95% CI 0.56-1.56). The independent predictors of death were diabetes, chronic renal failure, A-fib, frailty, and alternative access.

Age Just 1 Consideration

Although TAVR is increasingly being used in patients 90 years and older, little evidence exists on the feasibility and safety of the procedure in this group, the authors say. They add that mean patient ages in published RCTs and registries have ranged from 81.4 to 83.6 years, with few patients topping 90.

“The results of the present study indicate that performing balloon-expandable TAVI in nonagenarians is feasible and safe,” Dr. Abramowitz and colleagues write, noting that procedural success and short-term clinical outcomes were encouraging.

In particular, 30-day mortality rates were low regardless of age and were lower than had been observed in the oldest patients in prior studies (8.7%-15%). That disparity can be explained by the high volume of TAVR cases at the study center and by the exclusion of procedures performed before 2012, the authors say.

The elevated risk of minor vascular complications in patients 90 years or older “may partially be attributed to the increased rates of transfemoral access vs alternative access in [that group] in our study and to higher rates of calcification in the femoral artery in advanced age, although we did not assess this variable specifically in the present study,” the investigators write.

Nonetheless, Dr. Abramowitz said, “Based on our experience combined with the results of the present study, I believe that TAVR should not be [denied to] appropriate candidates based solely on advanced age. When considering candidates for TAVR, it is very important to comprehensively assess the patient based on cognitive function, mobility, [and] comorbidities and also to consider technical procedure-related features such as access-site characteristics.”

Isaac George, MD, of NewYork-Presbyterian/Columbia University Medical Center (New York, NY), agreed that age is only 1 factor playing into the decision about whether to offer a patient TAVR.

“I think this study formally puts down in writing what we have known for a while—that older patients do very well [with] TAVR if they are otherwise good anatomic candidates and functional in life,” he told TCTMD in an email. “Age often makes people high risk by perception, but many nonagenarians have self-selected themselves, in a Darwinian-evolutionary sense, and actually have very good life expectancy.”

Thus, he said, “the decision to proceed with any invasive procedure has… moved to a more comprehensive assessment of physiologic status, with frailty metrics, in-depth questioning about daily living, and quality of life, in addition to the usual medical testing.”

Patient Input Is Key

Also vital in the decision to perform TAVR, Dr. George added, is patient outlook and motivation, “which can often be the deciding factor in a successful versus failed recovery.”

Verghese Mathew, MD, of the Mayo Clinic (Rochester, MN), echoed the importance of including patients and their families in the discussion with cardiologists and surgeons about TAVR. “It’s a joint decision strongly dependent on patients’ input in terms of their preferences for treatment and what their expectations are of treatment,” he told TCTMD in a telephone interview, noting that such collaboration has been key since the early days of the procedure.

Older patients do “enjoy a symptom benefit and a survival benefit when they undergo a successful procedure,” he said. “In a 90-year-old who’s otherwise in pretty good shape, there’s no reason to turn them away from therapy just because they happen to be 90.”

Source: 
Abramowitz Y, Chakravarty T, Jilaihawi H, et al. Comparison of outcomes of transcatheter aortic valve implantation in patients ≥90 years versus <90 years. Am J Cardiol. 2015;Epub ahead of print.

Related Stories:

• Frailty Index Best at Predicting Functional Decline After TAVR
• TAVR Studies Tease Out Influences on Clinical Outcome
• Frailty Score Predicts 1-Year Mortality But Not Procedural Complications in TAVR