Outcomes of three different new generation transcatheter aortic valve prostheses

Abstract

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 Replacement with Self-Expandable ACURATE neo as Compared to Balloon-Expandable SAPIEN 3 in Patients with Severe Aortic Stenosis: Meta-Analysis of Randomized and Propensity-Matched Studies

“…Of those, 52 were further excluded because they were not pertinent to the design of the meta-analysis or did not meet the explicit inclusion criteria. One RCT [14] and five observational studies [15][16][17][18][19] enrolling the total of 2818 patients were eventually included in the analysis. Potential sources of the studies' bias were analyzed with the use of components recommended by the Cochrane Collaboration and ROBINS-I tool, and the results are enclosed as Table A2.…”

“…Aortic valve baseline echo-parameters, i.e., mean trans-aortic gradient were comparable: 43.4 ± 15.8 vs. 43.6 ± 15.5 mmHg (P = 0.861) in ACURATE neo and SAPIEN 3, respectively (Figure 2), although the aortic annulus plane area were on average 4 mm 2 smaller in the ACURATE neo recipients 439.7 ± 62.4 vs. 446.7 ± 76.3; P = 0.037 as compared to SAPIEN 3. Transfemoral access was mostly widely employed during TAVR procedure; in five studies, it was used exclusively [14,[16][17][18][19]. Barth et al [15] included both transfemoral and transapical access in 75.7% vs. 24.3% and 74.5% vs. 25.5% for ACURATE neo and SAPIEN 3, respectively.…”

“…Patients' baseline characteristics and detailed procedural characteristics are available as Tables A4 and A5. All studies reported data on 30-day clinical outcomes; three reported Kaplan-Meier estimates of survival at longer-term follow-ups [15,16,18].…”

“…Six studies [14][15][16][17][18][19] enrolling 2818 patients contributed data for the analysis of early safety as defined by VARC-2; with the corresponding rates of 13.9% (174/1256) and 12.6% (197/1562) for ACURATE neo and SAPIEN 3 valves, respectively, there were no statistical differences between two devices (RR 1.15, 95% CI, (0.94, 1.40) P = 0.16; I 2 = 0%) and pooled estimates of RCT and PS-matched studies in subgroup analysis (P interaction = 0.47) ( Figure 3a). In the pooled analysis of device success (five studies included (2634 patients.…”

“…To minimize these shortcomings, technological innovations were developed in next-generation valves including the following: balloon-expandable SAPIEN 3 (Edwards Lifesciences, Irvine, CA, USA) and self-expandable ACURATE neo (Boston Scientific Corporation, Marlborough, MA, USA). Since direct comparisons of these two devices are few and one recent randomized controlled trial (RCT) [14] did not demonstrate non-inferiority of the ACURATE neo device as compared to SAPIEN 3 as opposed to previous observational studies [15][16][17][18][19][20][21] that, however, pointed to comparable or superior results with ACURATE, the debate is ongoing.…”