Should Transcatheter Aortic Valve Replacement Be Performed in Nonagenarians?

Abstract

Background Despite clinical trial evidence and clinical experience supporting the efficacy of transcatheter aortic valve replacement (TAVR), data demonstrating the benefit of TAVR specifically in the very elderly patients are limited, as they often represent only a small proportion of the clinical trial populations. Objectives To compare the outcomes of nonagenarians to younger patients undergoing TAVR in current clinical practice. Methods National U.S. data from the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy (STS/ACC TVT) Registry were analyzed. Outcomes at 30-days and 1-year were compared between patients ≥90 vs <90 years of age using cumulative incidence curves. Quality of life was assessed with the 12-item Kansas City Cardiomyopathy Questionnaire (KCCQ-12). Results Between November 2011 and September 2014, 24,025 patients underwent TAVR in 329 participating hospitals, of which 3,773 (15.7%) were age ≥90. The 30-day and 1-year mortality was significantly higher among nonagenarians (≥90 vs. <90: 30-day: 8.8% vs. 5.9%, p<0.001; 1-year: 24.8% vs. 22.0%, p<0.001, absolute risk 2.8%, relative risk 12.7%). However, nonagenarians had a higher mean STS PROM score(10.9% vs. 8.1%; p<0.001) and therefore had similar ratios of observed to expected rates of 30-day death (≥90 vs. <90: 0.81, 95% CI 0.70–0.92 vs. 0.72, 95% CI 0.67–0.78). There were no differences in the rates of stroke, aortic valve reintervention or myocardial infarction at 30-days or 1-year. Nonagenarians had lower (worse) median KCCQ-12 scores at 30-days; however, there was no significant difference at 1-year. Conclusions In current U.S. clinical practice, approximately 16% of patients undergoing TAVR are ≥90 years of age. Although 30-day and 1-year mortality was statistically higher compared with younger patients undergoing TAVR, the absolute and relative differences were clinically modest. TAVR also improves quality of life to the same degree in nonagenarians as in younger patients. These data support safety and efficacy of TAVR in select very elderly patients.

Early Safety and Efficacy of Transcatheter Aortic Valve Implantation for Asian Nonagenarians (from KMH Registry)

“…There have been studies that assessed the safety and effectiveness of TAVI in nonagenarians in Europe and the USA. [17][18][19][20][21][22] In this study, 22.3% of patients were at least 90 years old. This is higher than the reported percentage of patients who underwent TAVI in the FRANCE-2 Registry (10.1%) 17) and the STS/ACC TVT Registry in the USA (15.7%).…”

“…23) In regard to the comparison of patients aged !90 and < 90 years after TAVI, the present study showed that there were no significant differences of 30-day and 1-year mortality rates. The FRANCE-2 data 17) on 30-day and 1-year mortality rates also did not achieve statistical significance, but in the STS/ACC TVT data, 22) the 30-day and 1-year mortality rates in nonagenarians were higher than in younger patients (age !90 years versus < 90 years: 30 days: 8.8% versus 5.9%; P < 0.001; one year: 24.8% versus 22.0%; P < 0.001). These might be reflected in average life expectancy.…”

“…This is higher than the reported percentage of patients who underwent TAVI in the FRANCE-2 Registry (10.1%) 17) and the STS/ACC TVT Registry in the USA (15.7%). 22) And in our registry, most patients aged !90 years had moderate to severe frailty compared with a previous single high-volume center report in the USA (83.3% versus 59.6%, respectively). 21) Interestingly, mortalities of nonagenarians at 30 days after the procedure in our registry (0.0%) were lower than in the foregoing reports (11.2% in the FRANCE-2 Registry 17) and 8.8% in the STS/ACC TVT Registry).…”

“…The FRANCE-2 data 17) did not achieve statistical significance in the rate of stroke (age !90 years versus 80-89 years: major stroke: 4.0% versus 4.6%; minor stroke: 1.2% versus 2.9%). On the other hand, the STS/ACC TVT data 22) showed that nonagenarians tended to suffer more strokes in hospital than patients aged < 90 years (2.72% versus 2.11%, P = 0.021). In this study, nonagenarians tended to develop TIA more frequently, suggesting that advancing age may influence strokes in patients who have undergone TAVI.…”

“…21) Interestingly, mortalities of nonagenarians at 30 days after the procedure in our registry (0.0%) were lower than in the foregoing reports (11.2% in the FRANCE-2 Registry 17) and 8.8% in the STS/ACC TVT Registry). 22) At one year, mortalities in patients aged !90 years in our registry were also lower than in the foregoing reports (8.4% in the KMH registry, 26.1% in the FRANCE-2 Registry, 17) and 24.8% in the STS/ACC TVT Registry 22) ). These results also compare favorably with the 7.6% 30-day mortality rate and 21.0% 1-year mortality rate reported for SAVR in selected nonagenarians.…”