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Multiplug paravalvular leak closure using Amplatzer Vascular Plugs III: A prospective registry
Grzegorz Smolka1, Piotr Pysz2, Marek Jasiński3
13rd Division of Cardiology, Medical University of Silesia, Katowice, Poland.
Summary
Transcatheter paravalvular leak closure (TPVLC) using multiple AVP III devices is safe and effective for heart failure symptoms. This multi-plug approach shows high success rates and lasting clinical benefits for patients with paravalvular leaks.
Area of Science:
- Cardiology
- Interventional Cardiology
- Medical Devices
Background:
- Transcatheter paravalvular leak closure (TPVLC) is an alternative to surgery for paravalvular leaks (PVL).
- Optimal technical strategies for TPVLC require further definition.
- This study assessed a prospective registry for TPVLC using a multi-plug, single-stage approach.
Purpose of the Study:
- To evaluate the safety and efficacy of a multi-plug, single-stage transcatheter paravalvular leak closure (TPVLC) approach.
- To assess the feasibility of simultaneously implanting multiple AVP III occluders for PVL closure.
- To determine the impact of TPVLC on heart failure symptoms and clinical outcomes.
Main Methods:
- Patients with heart failure symptoms due to PVL were selected by a Heart Team.
- Transcatheter paravalvular leak closure (TPVLC) utilized ante- or retrograde access for mitral PVLs and retrograde for aortic PVLs.
- Two to four AVP III devices were simultaneously implanted per paravalvular leak, with endpoints defined by VARC-2 criteria.
Main Results:
- Transcatheter paravalvular leak closure (TPVLC) was successful in 93.9% of 49 eligible patients, with an acute procedural success (APS) of 78%.
- Aortic PVLs had 100% APS, while mitral PVLs achieved 76.5% APS on first attempt, with an overall efficiency of 89.7%.
- Successful TPVLC significantly reduced NT-proBNP levels and heart failure symptoms, with minimal periprocedural complications (stroke, access site issues).
Conclusions:
- Simultaneous deployment of multiple AVP III occluders for transcatheter paravalvular leak closure (TPVLC) is feasible and safe.
- TPVLC demonstrates a high device success rate with significant reduction in heart failure symptoms and hemolysis.
- Clinical benefits, including reduced heart failure symptoms and no PVL recurrence, persist up to 1 year post-procedure.
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