What is the clinical evidence from this study?

Study design: Cohort. Population: Severe native valve aortic stenosis (n=607). Intervention: ACURATE neo/neo2 (Self-expanding valve) vs. SAPIEN 3/SAPIEN 3 Ultra (Balloon-expandable valve). Primary outcome: 1-year all-cause mortality (p=0.60).

What does this research mean for the field?

A prospective, anatomy-based device selection strategy using complementary self-expanding and balloon-expandable TAVI valves results in high technical success and comparable 1-year mortality between device types. Novelty: ClaimNovelty.INCREMENTAL. Consensus alignment: ConsensusAlignment.NEUTRAL.

What question did this study set out to answer?

This study evaluates how anatomic features can guide the selection of devices in TAVI to enhance outcomes.

May 31, 2026Frontiers in Cardiovascular Medicine0 citationsOpen Access

Partner valves: role of a prospective device selection strategy using ACURATE and SAPIEN 3 as complementary devices in transcatheter aortic valve implantation

JMJonathan M. Michel MCMi Chen NWNeria E. WinklerUniversity of Zurich

Key Result

A prospective device selection strategy using ACURATE and SAPIEN 3 valves resulted in comparable 1-year mortality (14% vs. 12%) and higher in-hospital intended performance for ACURATE (98% vs. 91%).

Key Points

This study evaluates how anatomic features can guide the selection of devices in TAVI to enhance outcomes.
607 patients with severe aortic stenosis treated using a device selection strategy at a single center from 2020 to 2023.
SAPIEN 3 was used for heavy/asymmetric calcification and bicuspid anatomy; ACURATE for small annulus and less calcified valves.
In-hospital Valve Academic Research Consortium-3 endpoints and 1-year mortality were assessed.
ACURATE used in 30% and SAPIEN 3 in 70% of patients.
In-hospital intended performance was better in the ACURATE group (98% vs. 91%, p = 0.005).
1-year mortality was 14% for ACURATE and 12% for SAPIEN 3 (log-rank p = 0.60).

Study Design

Type

Cohort (n=607)

Multicenter

Structured PICO

Does a prospective anatomy-based device selection strategy using ACURATE and SAPIEN 3 valves result in comparable outcomes for patients undergoing TAVI for severe aortic stenosis?

Population

607 consecutive patients with severe aortic stenosis treated at a single centre from 2020 to 2023.

Intervention

Transcatheter aortic valve implantation (TAVI) using ACURATE neo/ACURATE neo2 self-expanding valves, preferentially selected for small annulus dimensions and less calcified valves (n=182).

Comparator

Transcatheter aortic valve implantation (TAVI) using SAPIEN 3/SAPIEN 3 ULTRA balloon-expandable valves, preferentially selected for heavy and/or asymmetric valve calcification and bicuspid anatomy (n=425).

Outcome

In-hospital Valve Academic Research Consortium-3 (VARC-3) endpoints and 1-year mortality.composite

A prospective, anatomy-based device selection strategy for TAVI using self-expanding and balloon-expandable valves yields comparable technical success and 1-year mortality despite baseline clinical differences.

Main Result

Absolute Event Rate: 14% vs 12%

p-value: p=0.60

Limitations

Single-center, non-randomized observational design
Device selection was determined by implanting operators, introducing potential confounding factors
Incomplete follow-up prevented the evaluation of other relevant clinical endpoints
Lack of centralized patient follow-up
The latest-generation SAPIEN 3 ULTRA Resilia device was not available for this study

Abstract

Background Transcatheter aortic valve implantation (TAVI) outcomes using balloon-expandable valves (BEV) and self-expanding valves (SEV) differ owing to device-specific technical features and anatomical factors. Objectives This study aimed to evaluate prospective TAVI device selection based on anatomic features to optimise outcomes compared with published randomised data using two newer-generation devices. Methods A total of 607 consecutive patients with severe aortic stenosis treated at a single centre from 2020 to 2023 underwent TAVI using a prospective device selection strategy. Heavy and/or asymmetric valve calcification and bicuspid anatomy were preferentially treated with SAPIEN 3/SAPIEN 3 ULTRA BEV, whereas small annulus dimensions and less calcified valves were preferentially treated with ACURATE neo/ACURATE neo2 SEV. In-hospital Valve Academic Research Consortium-3 endpoints and 1-year mortality were evaluated. Results ACURATE was used in 182 (30%) patients and SAPIEN 3 in 425 (70%) patients. The proportion of women was higher in the ACURATE group (65% vs. 31%, p 0.001), and patients were older (84 vs. 80 years, p 0.001). Technical success (97% vs. 97%, p 0.99) and new permanent pacemaker implantation during index hospitalisation (10% vs. 10%, p 0.99) did not differ between the ACURATE and SAPIEN 3 groups. Intended performance was higher in the ACURATE group than in the SAPIEN 3 group (98% vs. 91%, p = 0.005), with aortic regurgitation ≥moderate (2% vs. 1%, p = 0.32), and mean transvalvular gradient ≥20 mmHg (1% vs. 4%, p = 0.043). The estimated mortality at 1 year was 14% versus 12% (log-rank p = 0.60) in the ACURATE and SAPIEN 3 groups, respectively. Conclusions A prospective device selection strategy using two complementary TAVI valves resulted in comparable outcomes between the SEV and BEV devices. In-hospital intended performance was higher in the ACURATE group. Despite baseline group differences, there was no difference in 1-year mortality.

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