Long- term results of interventional treatment of paravalvular leaks after prosthetic valve replacement with plug devices. Results from a prospective registry

Abstract

Abstract Background Interventional closure of paravalvular leaks (PVL) after surgical valve replacement has developed to an attractive treatment option for patients at high operative risk. 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. 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 was 68.,7 ± 13.5 years. Indication was symptomatic heart failure with NYHA class ≥ II (63.4%), hemolysis (4.9%) or NYHA class ≥ II and hemolysis (31.7%). Mean log. Euro-Score I was 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 minutes, fluoroscopy time was 31 minutes. Interventional closure of PVL was completely successful in 76%, partially successful in 10% and failed in 14%. Clinical improvement of at least 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. Postprocedurally a severe aortic PVL was described in 4.2% (preprocedural in 41.7%) and a severe mitral PVL was seen in 8.3% (preprocedural in 47.6%). Interventional complications occurred in 21.9%. 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 days (quartiles: 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. After one-year follow-up two reinterventions on the aortic valve (7.7%) were needed (one for PVL and one for treatment of an aortic stenosis), whereas two reinterventions (7.7%) were performed for mitral PVLs (1 percutaneous and 1 surgical PVL-closure). After 3-year follow-up one further percutaneous PVL closure (3.2%) was performed for an aortic and two further PVL closures (6.5%) for mitral PVLs (1 percutaneous, 1 surgical). After 5-year follow-up no PVL closure was necessary. The estimated rates for mortality and/or reintervention (either surgical or interventional) were 25.6% at one-year, 36.8% at 3 years and 45.1% 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.