Multiple Amplatzer Vascular Plug III Implantation---Feasible, Safe, and Effective for Paravalvular Leak Closure:...

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.

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.

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.

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.