Key result
Percutaneous PVL closure achieves ~71% technical success despite substantial two-year mortality in high-surgical-risk patients.
Why the study?
Transcatheter paravalvular leak closure offers an alternative to reoperation in high-risk patients, but data from Japan remain limited.
Observational (n=28)
No
Transcatheter paravalvular leak closure is feasible and effective in high-risk Japanese patients, with procedural success leading to improved clinical outcomes and reduced hemolysis.
Hypothesis-generating for transcatheter PVL closure in high-risk Japanese patients; leaves open long-term outcomes before clinical adoption.
While transcatheter paravalvular leak (PVL) closure offers a viable alternative to reoperation in high-risk patients, data from Japan remain limited. To address this, we retrospectively analyzed 28 consecutive patients who underwent percutaneous PVL closure at a single center in Japan between 2014 and 2022 (mitral, n = 23, aortic, n = 5; median follow-up, 2.0 years). We herein discuss real-time transesophageal echocardiography (TEE) with three-dimensional imaging, guided defect characterization, device sizing, and intra-procedural assessment. The study’s primary clinical endpoint was all-cause mortality, and its primary procedural endpoint was technical success, defined as a residual PVL < moderate on intra-procedural TEE in the absence of emergency surgery or death. The secondary clinical endpoint was a composite of all-cause death, heart failure hospitalization, or reintervention. Technical success was achieved in 71% of patients. Device strategies evolved over time: in earlier cases, the Amplatzer Vascular Plug II (AVP II) and Amplatzer Duct Occluder II (ADO II) were used off-label, whereas later on, dedicated rectangular PVL devices (PLDs) became the preferred choice, typically requiring fewer devices per case. Hemolysis indices (e.g., lactate dehydrogenase and total bilirubin) improved following successful PVL reduction, and patients with a residual PVL < moderate demonstrated superior clinical outcomes at follow-up. To facilitate benchmarking in elderly and renally impaired populations, we collected practical procedural metrics (procedure duration, contrast volume, and radiation exposure). This single-center experience demonstrates that transcatheter PVL closure is both feasible and effective in Japanese practice, while highlighting the importance of device selection and standardized intra-procedural TEE endpoints for procedural success.
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Hashimoto et al. (2026) conducted an observational in Paravalvular leak (PVL) (n=28). Percutaneous paravalvular leak (PVL) closure was evaluated on All-cause mortality. Percutaneous paravalvular leak closure achieved a 71% technical success rate and a 29% all-cause mortality rate over a median 2-year follow-up in high-surgical-risk patients.
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