Subscribe to RSS
Durability of Transcatheter Aortic Valves Beyond 5 Years: A Retrospective Single-Center Analysis
13 February 2020 (online)
Objectives: Transcatheter aortic valve implantation (TAVI) is increasingly advocated for younger patients (< 75 years) with aortic stenosis at low or intermediate surgical risk. However, long-term valve durability of transcatheter heart valves (THV) has not been demonstrated so far.
Methods: All patients who underwent TAVI between 2011 and 2015 were included (n = 266). Follow-up was complete in 81.6% (n = 217). Structural valve deterioration (SVD) was defined according to published criteria from the valve-in-valve international registry and graded Stage 1 to 3. A combined endpoint was created (death, reoperation, endocarditis, and SVD).
Results: Mean age was 83 ± 2.8 years with 54.8% female patients (n = 119). Types of THV used were Medtronic CoreValve (n = 172), CoreValve Evolut (n = 16), Edwards SAPIEN3 (n = 24), Boston Scientific Lotus (n = 5). Median follow-up of the overall cohort was 744 days (IQR: 50.0–1461.0) and 1,404 days (IQR: 1,114.5–1,703.5) in patients with echo follow-up. Kaplan–Meier survival at 1, 3, and 5 years was 71.6, 54.7, and 48.3%. Freedom from death, reoperation, endocarditis, and/or SVD at 1, 3, and 5 years was 69.7, 52.9, and 42.1%. Reoperation was necessary in 1.8% of patients (n = 4), due to paravalvular regurgitation (n = 2), transvalvular regurgitation (n = 1), and endocarditis (n = 1). During follow-up, 98 patients died and 31 of the surviving patients had echo during the recent 6 months. Median echo follow-up was 3.9 years (range: 2.3–6.2 years). In these patients, any degree of SVD was visible in 25.8% (8/31) and was moderate (Stage 2) in 9.7% (3/31). Half of patients with SVD were in NYHA class III (4/8). Mean gradient was 9.1 ± 4.5 mm Hg at discharge and 10.0 ± 4.6 mm Hg at follow-up. Moderate aortic regurgitation (AR) was observed in 3.1% (1/31); none of the patients had severe AR at follow-up. Time-related valve safety according to VARC2 was 83.8% (26/31).
Conclusion: Evaluation of valve durability in historical TAVI cohorts is difficult due to advanced age and comorbidities in TAVI patients at that time resulting in low survival rates beyond 3 years. Significant SVD was observed in a substantial share of survivors but was often asymptomatic and reoperation for SVD was rarely necessary. Before lowering the age recommendations of low and intermediate risk TAVI candidates below 75 years, more studies are necessary to investigate the actual durability of THV.