Background: Long-term durability and outcomes of transcatheter aortic valve implantation (TAVI) have been reported only with first generation devices. Objectives: To compare clinical efficacy of TAVI with Sapien 3 (Edwards Lifesciences), Evolut R/PRO (Medtronic) or Acurate Neo (Boston Scientific) transcatheter heart valves (THVs) at long-term. Methods: Consecutive TAVI patients treated with Sapien 3, Evolut R/PRO and Acurate Neo THVs at Policlinico G. Rodolico of Catania with at least 5 years follow-up were included in this analysis. Patients were divided into three different groups according to the TAVI device used. Outcomes were compared after inverse probability of treatment weighting adjustment. The primary endpoint was the composite of all-cause death, disabling stroke and heart failure (HF) re-hospitalization at 7 years. The co-primary endpoint was valve-related clinical efficacy according to Valve Academic Research Consortium 3 (VARC-3) definition, at 7 years. Results: From September 2014 to December 2018, 383 tranfemoral TAVI patients receiving Sapien 3 (n = 131, 34.2 %), Evolut R/PRO (n = 134, 34.9 %), or Acurate Neo (n = 118, 30.8 %) devices were compared. At 7 years, the composite primary endpoint did not differ among study groups (60.2 % vs. 51.6 % vs. 62.1 % for Sapien 3, Evolut R/PRO and Acurate Neo, respectively, plog-rank = 0.50). The co-primary endpoint was also similar (2.2 % vs. 1.2 % vs. 4.2 %, for Sapien 3, Evolut R/PRO and Acurate Neo, respectively, plog-rank = 0.86). Conclusions: Clinical efficacy of TAVI with Sapien 3, Evolut R/PRO and Acurate Neo devices was sustained and comparable up to 7 years. Low and similar rates of valve degeneration were reported among the three devices. Randomized clinical trials are necessary to corroborate these findings and to assess the impact of specific hemodynamic differences among the three THV platforms in the context of long-term clinical efficacy.
Long-term clinical efficacy of transfemoral transcatheter aortic valve implantation with three different platforms
Barbanti, Marco
2025-01-01
Abstract
Background: Long-term durability and outcomes of transcatheter aortic valve implantation (TAVI) have been reported only with first generation devices. Objectives: To compare clinical efficacy of TAVI with Sapien 3 (Edwards Lifesciences), Evolut R/PRO (Medtronic) or Acurate Neo (Boston Scientific) transcatheter heart valves (THVs) at long-term. Methods: Consecutive TAVI patients treated with Sapien 3, Evolut R/PRO and Acurate Neo THVs at Policlinico G. Rodolico of Catania with at least 5 years follow-up were included in this analysis. Patients were divided into three different groups according to the TAVI device used. Outcomes were compared after inverse probability of treatment weighting adjustment. The primary endpoint was the composite of all-cause death, disabling stroke and heart failure (HF) re-hospitalization at 7 years. The co-primary endpoint was valve-related clinical efficacy according to Valve Academic Research Consortium 3 (VARC-3) definition, at 7 years. Results: From September 2014 to December 2018, 383 tranfemoral TAVI patients receiving Sapien 3 (n = 131, 34.2 %), Evolut R/PRO (n = 134, 34.9 %), or Acurate Neo (n = 118, 30.8 %) devices were compared. At 7 years, the composite primary endpoint did not differ among study groups (60.2 % vs. 51.6 % vs. 62.1 % for Sapien 3, Evolut R/PRO and Acurate Neo, respectively, plog-rank = 0.50). The co-primary endpoint was also similar (2.2 % vs. 1.2 % vs. 4.2 %, for Sapien 3, Evolut R/PRO and Acurate Neo, respectively, plog-rank = 0.86). Conclusions: Clinical efficacy of TAVI with Sapien 3, Evolut R/PRO and Acurate Neo devices was sustained and comparable up to 7 years. Low and similar rates of valve degeneration were reported among the three devices. Randomized clinical trials are necessary to corroborate these findings and to assess the impact of specific hemodynamic differences among the three THV platforms in the context of long-term clinical efficacy.I documenti in IRIS sono protetti da copyright e tutti i diritti sono riservati, salvo diversa indicazione.
