Outcomes of three different new generation transcatheter aortic valve prostheses

• DOI: 10.1002/ccd.28524
• Publication Date: 2019-10-14T10:34:05Z
• Authors: Giuliano Costa; Sergio Buccheri; Marco Barbanti; Andrea Picci; Denise Todaro; Emanuela Di Simone; Ketty La Spina; Paolo D'Arrigo; Enrico Criscione; Marco Nastasi; Carmelo Sgroi; Corrado Tamburino
• Keywords: Aged, 80 and over; Male; Time Factors; Hemodynamics; Aortic Valve Stenosis; Recovery of Function; Prosthesis Design; Severity of Illness Index; 3. Good health; Transcatheter Aortic Valve Replacement; 03 medical and health sciences; Treatment Outcome; 0302 clinical medicine; Aortic Valve; Heart Valve Prosthesis; Humans; Female; Aged; Retrospective Studies

AbstractAimsTo evaluate outcomes of transfemoral transcatheter aortic valve implantation (TF‐TAVI) using three different new‐generation devices.BackgroundAlthough new generation transcatheter aortic valves (TAVs) have demonstrated to improve procedural outcomes, to date few head‐to‐head comparisons are available among these devices.MethodsThis 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.RESULTSThe 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).ConclusionsTAVI 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.