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

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.