What does this research mean for the field?

The Evolut R transcatheter valve significantly reduces 30-day composite safety endpoints and procedural complications compared with the first-generation CoreValve in patients undergoing transcatheter aortic valve replacement. Novelty: ClaimNovelty.INCREMENTAL. Consensus alignment: ConsensusAlignment.NEUTRAL.

October 27, 2021Open Access

Outcomes and Hemodynamic Performances of Transcatheter Aortic Valve Replacement With Two Generations of Self-expanding Transcatheter Aortic Valves

Q: What is the clinical evidence from this study?

Study design: Cohort. Population: Severe aortic stenosis (n=234). Intervention: Evolut R transcatheter aortic valve vs. CoreValve transcatheter aortic valve. Primary outcome: 30-day composite safety endpoint (p=0.004).

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Key result

Evolut R linked to ~72% fewer 30-day major safety events versus CoreValve in severe AS.

P=0.004
n=234

Why the study?

The hemodynamic and clinical performance differences between the Evolut R and its predecessor CoreValve in TAVR patients were not well characterized in the Taiwanese population.

Does TAVR with the Evolut R valve improve 30-day safety outcomes and hemodynamic performance compared to the CoreValve in patients undergoing TAVR?

Comparison

TAVR with Evolut R vs TAVR with CoreValve

Design

Cohort study

Follow-up

30 days

Authors

CKChia-Cheng Kuo HCHsiao‐Huang Chang HLHsin‐Bang Leu

Discussion

Member takes

Overview

Evolut R was associated with fewer 30-day events; leaves open whether randomized trials confirm superiority over CoreValve.

Study Design

Type

Cohort (n=234)

Multicenter

Structured PICO

Does TAVR with the Evolut R valve improve 30-day safety outcomes and hemodynamic performance compared to the CoreValve in patients undergoing TAVR?

Population

234 patients with severe aortic stenosis considered unsuitable or at high risk for surgical aortic valve replacement, followed for 30 days after transcatheter aortic valve replacement.

Exposure

Transcatheter Aortic Valve Replacement (TAVR) with the newer generation Evolut R self-expanding valve

Comparator

Transcatheter Aortic Valve Replacement (TAVR) with the older generation CoreValve self-expanding valve

Outcome

30-day Valve Academic Research Consortium-2 (VARC-2)-defined outcomes and hemodynamic performancescomposite

Main Result

Absolute Event Rate: 4.3% vs 15.4%

p-value: p=0.004

The newer generation Evolut R self-expanding valve significantly improves 30-day safety outcomes, including lower rates of stroke and emergent conversion to open surgery, compared to the older CoreValve in patients undergoing TAVR.

Limitations

Single-center retrospective and observational design
Results of CoreValve could have been affected by the learning curve of TAVR in the early stages, potentially overstating the benefit of Evolut R

Cite This Study

Kuo et al. (2021) conducted a cohort in Severe aortic stenosis (n=234). Evolut R transcatheter aortic valve vs. CoreValve transcatheter aortic valve was evaluated on 30-day composite safety endpoint (p=0.004). The Evolut R valve significantly reduced the 30-day composite safety endpoint to 4.3% compared to 15.4% with the CoreValve in patients with severe aortic stenosis.

synapsesocial.com/papers/6aadecbae515d8f54ff83a92 https://doi.org/10.21203/rs.3.rs-953688/v1

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October 27, 2021Open Access

Outcomes and Hemodynamic Performances of Transcatheter Aortic Valve Replacement With Two Generations of Self-expanding Transcatheter Aortic Valves

View Full Paper

Ask AI

Bookmark

Key result

Evolut R linked to ~72% fewer 30-day major safety events versus CoreValve in severe AS.

P=0.004
n=234

Why the study?

The hemodynamic and clinical performance differences between the Evolut R and its predecessor CoreValve in TAVR patients were not well characterized in the Taiwanese population.

Does TAVR with the Evolut R valve improve 30-day safety outcomes and hemodynamic performance compared to the CoreValve in patients undergoing TAVR?

Comparison

TAVR with Evolut R vs TAVR with CoreValve

Design

Cohort study

Follow-up

30 days

Authors

CKChia-Cheng Kuo HCHsiao‐Huang Chang HLHsin‐Bang Leu

Discussion

Member takes

Overview

Evolut R was associated with fewer 30-day events; leaves open whether randomized trials confirm superiority over CoreValve.

Study Design

Type

Cohort (n=234)

Multicenter

Structured PICO

Does TAVR with the Evolut R valve improve 30-day safety outcomes and hemodynamic performance compared to the CoreValve in patients undergoing TAVR?

Population

234 patients with severe aortic stenosis considered unsuitable or at high risk for surgical aortic valve replacement, followed for 30 days after transcatheter aortic valve replacement.

Exposure

Transcatheter Aortic Valve Replacement (TAVR) with the newer generation Evolut R self-expanding valve

Comparator

Transcatheter Aortic Valve Replacement (TAVR) with the older generation CoreValve self-expanding valve

Outcome

30-day Valve Academic Research Consortium-2 (VARC-2)-defined outcomes and hemodynamic performancescomposite

Main Result

Absolute Event Rate: 4.3% vs 15.4%

p-value: p=0.004

Limitations

Single-center retrospective and observational design
Results of CoreValve could have been affected by the learning curve of TAVR in the early stages, potentially overstating the benefit of Evolut R

Cite This Study

synapsesocial.com/papers/6aadecbae515d8f54ff83a92 https://doi.org/10.21203/rs.3.rs-953688/v1

View Full Paper

Ask AI

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