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A Simplified Stepwise Approach to Echo Guidance during Percutaneous Mitral Valve Repair
Published on: October 16, 2021
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Transcatheter Mitral Valve Replacement With the Transseptal EVOQUE System.
John Webb1, Mark Hensey1, Neil Fam2
1St. Paul's Hospital, Vancouver, British Columbia, Canada.
JACC. Cardiovascular Interventions
|October 23, 2020
Summary
This study shows the transseptal transcatheter mitral valve replacement (TMVR) system is feasible for treating mitral regurgitation (MR). The EVOQUE TMVR system achieved high technical success and improved patient function.
Area of Science:
- Cardiovascular Medicine
- Interventional Cardiology
- Medical Devices
Background:
- Transcatheter mitral valve replacement (TMVR) offers a less invasive alternative to surgery for mitral regurgitation (MR).
- Existing transcatheter repair methods have limitations, driving the need for novel TMVR systems.
- The transseptal approach presents a potentially advantageous route for TMVR delivery.
Purpose of the Study:
- To evaluate the initial clinical experience and feasibility of a novel transseptal TMVR system.
- To assess the safety and efficacy of the EVOQUE TMVR system in patients with high surgical risk.
- To determine the technical success rate and early clinical outcomes of transseptal TMVR.
Main Methods:
- A first-in-human study involving 14 patients with moderate to severe MR and high surgical risk.
- Treatment utilized the EVOQUE TMVR system between September 2018 and October 2019.
- Primary endpoint was technical success, defined by Mitral Valve Academic Research Consortium criteria; secondary endpoints included 30-day safety and functional outcomes.
Main Results:
- Technical success was achieved in 92.9% of patients (13 out of 14).
- At 30 days, MR was mild or less in all implanted patients (83.3% had no MR), and 81.8% improved to NYHA functional class ≤II.
- Early safety events included one non-cardiovascular mortality and two strokes; no myocardial infarctions or rehospitalizations occurred.
Conclusions:
- The transseptal EVOQUE TMVR system demonstrates initial feasibility for treating severe mitral regurgitation.
- This novel approach may overcome some limitations of existing transcatheter mitral valve interventions.
- Further clinical investigation is warranted to confirm the safety and long-term clinical benefits of this TMVR system.
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