Nonagenarians Fare Well After TAVR, Once They Get Beyond 30 Days

BARCELONA, Spain—Patients 90 years of age and older who undergo transcatheter aortic valve replacement and emerge unscathed through the first 30 days have equivalent clinical outcomes at 1 and 2 years compared with younger patients.

In that first 30 days, however, nonagenarians have nearly a twofold higher risk of dying from all causes.  

Adriano Caixeta, MD (Hospital Israelita Albert Einstein, Sao Paulo, Brazil), who presented results from the Brazilian TAVI Registry this week at the European Society of Cardiology (ESC) Congress 2017, said that while the percutaneous intervention is standard treatment for many patients with aortic stenosis, “there is a debate about the utility of TAVI in some very high-risk subgroups of patients, including nonagenarians.”

Rosa Ana Hernandez Antolin, MD (Hospital Ramón y Cajal, Madrid, Spain), who chaired a ESC press conference where the results were presented, said that while nonagenarians had a significantly increased risk in the first 30 days, other data have suggested that “if they survive, the reality is that their quality of life is as good as others.”

Caixeta agreed, noting that although the study did not include a quality-of-life analysis, “if you look at the New York Heart Association classification, out to 2 years’ follow-up, most of the patients are in class I or class II functional class, which is important for quality of life.”

These new data should help alleviate concerns about treating higher-risk older patients, said Caixeta. This is particularly important as TAVR expands and worldwide demographics shift, a combination that means physicians are likely to be tasked with caring for significantly older patients with aortic stenosis.

Results Equivalent at 1 and 2 Years

In the Brazilian TAVI Registry, which included 819 patients enrolled between 2008 and 2015, approximately 10% were 90 years of age and older. The average age of the nonagenarians was 92 years, and nearly all had some degree of renal insufficiency. The nonagenarians also had a significantly higher mean STS risk score (13.19 vs 9.87; P < 0.001). Most of the Brazilian patients were treated with CoreValve (Medtronic)—about two-thirds—and the remainder received the Sapien XT (Edward Lifesciences) device.

At 30 days, 15.6% of the nonagenarians had died compared with 8.4% of the younger patients (P = 0.03). There was no significant difference in the rate of stroke and major bleeding between the older and younger patients, although there was a trend toward a higher rate of major adverse cardiovascular events in the nonagenarians (19.1% vs 12.0%; P = 0.06).

At 1 year, 20.9% of the nonagenarian TAVR patients had died, a rate that was not significantly different than the 21.8% all-cause mortality rate in patients younger than 90 years. Again, there was no significant difference in the rate of stroke or major adverse cardiovascular events. In patients with follow-up to 2 years, there was no difference in outcomes.  

“We were surprised that up to 2 years, all-cause mortality and major adverse cardiovascular events were pretty much similar [in nonagenarians] with those younger than 90 years old,” said Caixeta. “It’s important to highlight that when we face a 90-year-old patient, we have to get together with the heart team to individualize patient [care], look at their communicative status, frailty, and then decide if it’s worth treating this patient with TAVI.”

He added that physicians in Brazil primarily used older TAVR devices and that with the shift to newer products, such as CoreValve Resolute (Medtronic) and Sapien 3 (Edwards Lifesciences), “they are expecting even better results in nonagenarians.”   

In general, nonagenarians are underrepresented in clinical trials. Only 10% of patients in their registry were 90 years and older, whereas the proportion is higher in the Society of Thoracic Surgeons/American College of Cardiology TVT Registry. Speaking with the media, Caixeta said the Brazilian registry is important as it represents TAVR performed in a “developing country” where the life expectancy is just 70 years old, which explains the low rate of nonagenarians in their registry.