Transcatheter aortic valve replacement: clinical safety and performance data

Area of Science:

• Cardiovascular Medicine
• Interventional Cardiology
• Medical Device Technology

Background:

• Severe aortic stenosis and regurgitation pose significant risks for surgical intervention.
• Transcatheter aortic valve replacement (TAVR) provides an alternative for inoperable or high-risk patients.
• A comprehensive understanding of TAVR's clinical and performance outcomes is crucial.

Purpose of the Study:

• To conduct a comprehensive literature review of transcatheter aortic valve replacement (TAVR).
• To summarize reported clinical and performance outcomes associated with various TAVR devices.
• To identify trends and variations in outcome reporting across existing studies.

Main Methods:

• Systematic literature search encompassing 204 articles.
• Inclusion of data from 16 different transcatheter aortic valve replacement devices.
• Analysis of reported clinical outcomes (mortality, stroke, pacemaker implantation) and valve performance (aortic regurgitation).

Main Results:

• Frequently reported outcomes included 30-day mortality (0-23%), 30-day stroke (0-14.3%), and pacemaker implantation (0-44.9%).
• Aortic valve regurgitation was the most common performance outcome, typically assessed at 7-day follow-up.
• Limited studies reported outcomes beyond 30 days or included intermediate and low-risk patient populations.

Conclusions:

• This review provides an overview of TAVR clinical and performance outcomes, despite variations in reporting definitions (e.g., VARC-2).
• Significant heterogeneity exists in study methodologies and outcome reporting across the literature.
• Standardized definitions for study setups and outcomes are essential for future research to enhance insights into TAVR effectiveness.