Multiple Amplatzer Vascular Plug III Implantation---Feasible, Safe, and Effective for Paravalvular Leak Closure: Results From a Single-center Registry
Bibliographic record
Abstract
BACKGROUND: Paravalvular leaks (PVLs) can cause heart failure and hemolysis. Transcatheter PVL closure (tPVLc) is a reasonable alternative to surgical repair, particularly in high-risk patients. The complexity of PVL channels makes the selection of an optimal device and technical strategy challenging. In this study we present retrospective registry findings of consecutive tPVLc procedures and evaluate the feasibility, safety, and efficacy of the multioccluder approach using the Amplatzer ParaValvular Plug III device. METHODS: We analyzed data from 127 consecutive patients with 142 perivalvular leaks (73 para-aortic, 69 paramitral) in whom 152 tPVLc procedures were performed between 2009 and 2023, with 2-4 occluders used to close each PVL. RESULTS: Successful leak closure was achieved in 141 of the 142 leaks, with 131 occluded on the first attempt (technical success 93%) and 10 on the second attempt. Procedural success (technical success and freedom from major adverse cardiac and cerebrovascular events [MACCEs]) was achieved in 89% of the patients, whereas incomplete PVL closure was observed in 3% and periprocedural major adverse cardiovascular events in 2 patients. At 1-year follow-up, device dislodgement was noted in 2 patients, and leak reoccurrence - in 4 patients. Eleven patients died. At long-term follow-up (median 25 months, interquartile range 10-40 months), MACCEs occurred in 19 patients, and was associated with mechanical valve leaks (odds ratio 3.4, 95% confidence interval 1.3-9.2). Long-term all-cause mortality was 17.6% and was associated with baseline New York Heart Association class. CONCLUSIONS: tPVLc using multiple AVP III occluders is a feasible, safe, and effective strategy for patients with clinically significant PVLs with complex anatomy. Long-term follow-up revealed a low incidence of leak reoccurrence and device-related adverse effects.
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.002 | 0.004 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.002 |
| Bibliometrics | 0.001 | 0.001 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.002 | 0.001 |
| Open science | 0.001 | 0.001 |
| Research integrity | 0.001 | 0.001 |
| Insufficient payload (model declined to judge) | 0.002 | 0.000 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".