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. 2024 May 10;20(9):579-590.
doi: 10.4244/EIJ-D-23-00996.

Performance and outcomes of the SAPIEN 3 Ultra RESILIA transcatheter heart valve in the OCEAN-TAVI registry

Masanori Yamamoto  1   2   3 , Fumiaki Yashima  4 , Shinichi Shirai  5 , Norio Tada  6 , Toru Naganuma  7 , Masahiro Yamawaki  8 , Futoshi Yamanaka  9 , Kazuki Mizutani  10 , Masahiko Noguchi  11 , Hiroshi Ueno  12 , Kensuke Takagi  13 , Yohei Ohno  14 , Masaki Izumo  15 , Hidetaka Nishina  16 , Hiroto Suzuyama  17 , Kazumasa Yamasaki  18 , Kenji Nishioka  19 , Daisuke Hachinohe  20 , Yasushi Fuku  21 , Toshiaki Otsuka  22   23 , Masahiko Asami  24 , Yusuke Watanabe  25 , Kentaro Hayashida  26 , On Behalf Of The Ocean-Tavi Investigators
Affiliations

Performance and outcomes of the SAPIEN 3 Ultra RESILIA transcatheter heart valve in the OCEAN-TAVI registry

Masanori Yamamoto et al. EuroIntervention. .

Abstract

Background: Data on the performance of the latest-generation SAPIEN 3 Ultra RESILIA (S3UR) valve in patients who undergo transcatheter aortic valve replacement (TAVR) are scarce.

Aims: We aimed to assess the clinical outcomes, including valve performance, of the S3UR.

Methods: Registry data of 618 consecutive patients with S3UR and of a historical pooled cohort of 8,750 patients who had a SAPIEN 3 (S3) valve and underwent TAVR were collected. The clinical outcomes and haemodynamics, including patient-prosthesis mismatch (PPM), were compared between the 2 groups and in a propensity-matched cohort.

Results: The incidence of in-hospital death, vascular complications, and new pacemaker implantation was similar between the S3UR and the S3 groups (allp>0.05). However, both groups showed significant differences in the degrees of paravalvular leakage (PVL) (none-trivial: 87.0% vs 78.5%, mild: 12.5% vs 20.5%, ≥moderate: 0.5% vs 1.1%; p<0.001) and the incidence of PPM (none: 94.3% vs 85.1%, moderate: 5.2% vs 12.8%, severe: 0.5% vs 2.0%; p<0.001). The prevalence of a mean pressure gradient ≥20 mmHg was significantly lower in the S3UR group (1.6% vs 6.2%; p<0.001). Better haemodynamics were observed with the smaller 20 mm and 23 mm S3UR valves. The results were consistent in a matched cohort of patients with S3UR and with S3 (n=618 patients/group).

Conclusions: The S3UR has equivalent procedural complications to the S3 but with lower rates of PVL and significantly better valve performance. The better valve performance of the S3UR, particularly in smaller valve sizes, overcomes the remaining issue of balloon-expandable valves after TAVR.

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Conflict of interest statement

K. Nishioka is a clinical proctor for Edwards Lifesciences. M. Izumo is a screening proctor for Edwards Lifesciences. F. Yashima, Y. Ohno, and M. Asami are clinical proctors for Medtronic. T. Naganuma, K. Mizutani, H. Ueno, K. Takagi, and Y. Fuku are clinical proctors for Edwards Lifesciences and Medtronic. M. Yamamoto, S. Shirai, N. Tada, K. Yamasaki, D. Hachinohe, Y. Watanabe, and K. Hayashida are clinical proctors for Edwards Lifesciences, Abbott, and Medtronic. The other authors have no conflicts of interest to declare.

Figures

Figure 1
Figure 1. Study flowchart.
PS: propensity score; TAV in SAV: transcatheter aortic valve in surgical aortic valve
Figure 2
Figure 2. Incidence of moderate PPM, severe PPM, PVL ≥mild, and mPG ≥20 mmHg by valve size of S3UR and S3 THVs.
A) Moderate PPM; B) Severe PPM; C) PVL ≥mild; D) mPG ≥20 mmHg. mPG: mean pressure gradient; PPM: patient-prosthesis mismatch; PVL: paravalvular leakage; S3: SAPIEN 3; S3UR: SAPIEN 3 Ultra RESILIA; THV: transcatheter heart valve
Figure 3
Figure 3. Scatter plot between the baseline CT annulus area and postprocedural echocardiographic findings in the S3UR (red dots) and S3 (blue dots).
A) Relationship between the baseline CT annulus area and postprocedural EOA. B) Relationship between the baseline CT annulus area and postprocedural iEOA. CT: computed tomography; EOA: effective orifice area; iEOA: indexed EOA
Figure 4
Figure 4. The estimated PPM rates of the S3UR based on each BSA size between the Japanese and non-Japanese cohorts.
BSA: body surface area; PPM: patient-prosthesis mismatch; S3UR: SAPIEN 3 Ultra RESILIA
Central illustration
Central illustration. Comparison of valve performance between S3UR and S3 THVs as evaluated according to the incidence of PPM, PVL ≥mild, and mPG ≥20 mmHg in the entire cohort and in the PS-matched cohort.
A) The patient population between the S3UR and S3 in this study. B) The incidence of PVL ≥mild and mPG ≥20 between the S3UR and S3 (Right: overall cohort, Left: PS-matched cohort). C) The incidence of PPM between the S3UR and S3 in the overall cohort. D) The incidence of PPM between the S3UR and S3 in the PS-matched cohort. mPG: mean pressure gradient; PPM: patient-prosthesis mismatch; PS: propensity score; PVL: paravalvular leakage; S3: SAPIEN 3; S3UR: SAPIEN 3 Ultra RESILIA; THV: transcatheter heart valve
See this image and copyright information in PMC

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