Acute and long-term results of interventional treatment of paravalvular leaks after prosthetic valve replacement with plug devices: results from a prospective multicentre registry.

Abstract

Background: Interventional closure of symptomatic paravalvular leaks (PVL) after valve replacement has developed to an attractive treatment option for patients at high operative risk. However, prospective and long-term data are sparse.

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

Results: 41 patients with symptomatic PVL were included in the plug registry at nine German hospitals from 2014 until 2020. In total 50 interventions with 67 plug implantations were recorded, 46.3% of procedures were performed for aortic and 53.7% for mitral PVLs. In 82% of patients PVL closure was performed once, in 16% twice and 2% underwent three procedures. Indication for PVL closure was symptomatic heart failure with NYHA class ≥ II (63.4%), haemolysis (4.9%), or NYHA class ≥ II and haemolysis (31.7%). PVL closure was completely successful in 76%, partially successful in 10% and failed in 14%. Acute improvement of one NYHA class was achieved in 56.4% and of two NYHA classes in 15.4%. Postprocedural no residual severe aortic PVL was described and residual severe mitral PVL was seen in 4.8%. Postinterventional 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. Calculated mortality rates were 10.1% at 1-year-, 18.5% at 3-year- and 32.5% at 5-year-follow-up. The estimated rates for mortality and/or reintervention (surgical or interventional) were 25.6% at 1-year, 36.8% at 3-year and 45.1% at 5-year follow-up.

Conclusions: The multicentre German Plug-Registry describes a high procedural success rate with clinical improvement in most patients and acceptable long-term outcomes after percutaneous PVL closure.

Trial registration number: NCT03179969.