Background: Interventional closure of paravalvular leaks (PVL) after surgical valve replacement has developed to an attractive treatment option for patients at high operative risk. Surgical PVL closure is associated with high morbidity and mortality rates. There is a lack of prospective data on long- term clinical outcome after percutaneous PVL closure.

Methods: We analysed data from a multicenter prospective registry on interventional PVL closure.

Results: 41 patients (10 women and 31 men) with symptomatic PVL were included in the plug registry at nine German hospitals from 2014 until 2020. 23 patients were prospectively enrolled from 05/2017 until 06/2020 and 18 patients were retrospectively included from 08/2014 until 05/2017. In total 67 plug implantations were accomplished, 46,3% of procedures were performed for aortic PVLs and 53,7% were done for mitral PVLs. In 82% of patients PVL closure was performed once, in 16% of patients twice and 2,0% underwent three procedures. Mean age of the population treated was 68,7 ± 13,5 years. Indication for PVL closure was symptomatic heart failure with NYHA class ≥ II (63,4%), hemolysis (4,9%) or NYHA class ≥ II and hemolysis (31,7%). The operative risk was described with a mean log. Euro-Score I (16,6 ± 11,6%). Aortic PVLs were treated using a retrograde transfemoral access (100%), mitral PVLs were treated using either a transseptal (96%) or transapical access (4%). For the first performed PVL closure the median procedural time was 100,0 minutes (quartiles: 63,0 and 140,0), the fluoroscopy time was 31,0 minutes (quartiles: 24,0 and 57,0). Interventional closure of PVL was completely successful in 76 %, partially successful in 10 % and failed in 14% of all the procedures. Clinical improvement of one NYHA class was achieved in 56,4% and of two NYHA classes in 15,4% of patients after the procedure. In 7,3% hemolysis and transfusion dependence were successfully treated by plug implantation. Postprocedural a severe aortic PVL was described in 4,2% (preprocedural in 39,3%) and a severe mitral PVL was seen in 8,3% (preprocedural in 32,4%). Postprocedurally severe residual aortic PVL was described in 4,2% (preprocedurally 39,3%), whereas severe residual mitral PVL was seen in 8,3% of patients (preprocedurally 32,4%). Postinterventional complications occurred in 21,9% (major bleeding with transfusion 7,3% vascular complications 7,3%). The in-hospital mortality rate was 4,9%. A follow-up was performed after 30 days, 12 months, 3 and 5 years. Within a median time of 511 (45;1136) days 10 patients died. Mortality rates were 10,1% at one-year-, 18,5% at 3-year- and 32,5% at 5-year-follow-up. The estimated rates for mortality and/or reintervention (either surgical or interventional) were 28,1% at one-year, 39,4% at 3 years and 52,8% at 5-year follow-up.

Conclusion: The multicenter plug-registry describes a high procedural success rate with clinical improvement in the majority of patients and acceptable long-term outcomes after percutaneous PVL closure.Interventional PVL closure confirms to be an attractive alternative for surgical PVL closure, at least in patients at high surgical risk.