Aims To evaluate outcomes of transfemoral transcatheter aortic valve implantation (TF‐TAVI) using three different new‐generation devices. Background Although new generation transcatheter aortic valves (TAVs) have demonstrated to improve procedural outcomes, to date few head‐to‐head comparisons are available among these devices. Methods This is a single center, retrospective study. From September 2014 to February 2018, 389 patients underwent elective TF‐TAVI for native, severe aortic stenosis using a new‐generation transcatheter aortic valve (TAV) with a preprocedural multi‐detector computed tomography assessment. Among these, 346 patients received an Edwards SAPIEN 3 (n = 134), Medtronic Evolut R (n = 111), or Boston ACURATE neo (n = 101) prosthesis. Differences in baseline clinical characteristics between groups were accounted using the propensity score weighting method. RESULTS The mean age for the entire study cohort was 81.4 ± 5.2 years while the Society of Thoracic Surgery predicted risk of mortality was 4.0 ± 2.5%. After propensity score weighting adjustment, TAVs did not differently impact on 30‐day all‐cause and cardiovascular mortality. Evolut R device showed an increased risk of permanent pacemaker implantation (PPI) after the procedure (8.3% for SAPIEN 3 vs. 16.7% for Evolut R vs. 2.1% for ACURATE neo, p < .05). At 30 days, patients treated with SAPIEN 3 valve showed a higher mean transvalvular gradient (9.7 ± 7.5 mmHg vs. 6.1 ± 2.4 mmHg vs. 8.4 ± 3.5 mmHg for SAPIEN 3, Evolut R, and ACURATE neo, respectively, p < .01) and a lower rate of more‐than‐trace paravalvular regurgitation (PVR) (18.8 vs. 47.9 vs. 45.8%, for SAPIEN 3, Evolut R, and ACURATE neo, respectively, p < .01). At 1 year, SAPIEN 3, Evolut R, and ACURATE neo TAVs showed excellent and comparable outcomes with no difference in terms of freedom from major adverse cardiovascular and cerebrovascular event (MACCE) (plog‐rank = 0.534). Conclusions TAVI using new‐generation prostheses was associated with high device success (97.0% vs. 92.8% vs. 95.0% for SAPIEN 3, Evolut R and ACURATE neo, respectively) and low complications rates up to 1 year. Evolut R valve was associated with a higher rate of PPI whereas SAPIEN 3 valve was associated with a higher mean transvalvular gradient and lower rate of more‐than‐trace PVR. At 1‐year, MACCE rates were similar among the three groups.
Transcatheter aortic valve implantation (TAVI) has become the standard of care for high-risk and inoperable surgical patients and a valid alternative to surgery for low- and intermediate-risk patients with severe, symptomatic aortic stenosis. It is increasingly being used for younger, lower-risk patients, so it is important to ensure the durability for long-term transcatheter aortic valves. The lack of standard definitions of structural valve degeneration (SVD) had made comparison among studies on prosthetic valve durability problematic. The 2017 standardised definitions of SVD by the European Association of Percutaneous Cardiovascular Intervention), the European Society of Cardiology and the European Association for Cardio-Thoracic Surgery, and the 2018 definitions by the Valve In Valve International Data group, has generated an increased uniformity in evaluations. This article examines the potential mechanisms and rates of SVD of transcatheter bioprostheses and the role of redo TAVI as a treatment option.
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