Interventional treatment of paravalvular regurgitation by plug implantation following prosthetic valve replacement: a single-center experience.

BACKGROUND: Interventional closure of paravalvular leaks (PVL) by plug implantation has emerged as an alternative to surgical correction, which is associated with high mortality rates for re-operation. To date, data on procedural efficacy and clinical outcome after transcatheter closure is sparse. We present our experience with interventional PVL closure at our site.

METHODS AND RESULTS: From 08/2014 to 10/2016 ten patients (three women, seven men) at high surgical risk for repeat surgery underwent interventional PVL closure for severe paravalvular regurgitation (PVR) in 14 procedures at our site. Nine procedures (64%) were performed for mitral PVLs, five procedures were performed for aortic PVLs (36%). Mean age of the population treated was 70 ± 8.6 years and mean log. Euro-Score I was 27.4 ± 14.9%. All patients were treated by implantation of Amplatzer Vascular Plug III occluders. All aortic PVLs were treated using a retrograde transfemoral access, mitral PVLs were treated using either a transseptal (8/9) or transapical access (1/9) under 3-dimensional transesophageal echocardiographic and fluoroscopic guidance. Indication for PVL closure was the presence of severe heart failure symptoms in all patients (NYHA class III/IV, n = 14) and additional mechanical hemolytic anemia (n = 5) with a need for transfusion. Interventional closure of PVL was completely successful in 12 procedures (85%), partially successful in one procedure due to inability to cross the defect with a wire (7.5%) and failed in one of 14 procedures due to inability of plug deployment in a very large defect (7.5%). One patient in a critical clinical condition died within 24 h after procedure due to progressive cardiogenic shock after procedural failure and refusal of a surgical treatment by cardiac surgeons. After interventional treatment clinical success with improvement in NYHA functional class or hemolysis was achieved in 93% (13/14). Median NYHA class improved significantly from 4 prior to procedure to 2 after PVL closure (p = 0.0005). Severe PVR was significantly reduced to mild in six patients and to moderate in three patients after procedure (p = 0.001). Complications included one hemothorax after transapical access and one pseudoaneurysm after transfemoral arterial access. In-hospital mortality rate was 20% (2/10) in this high-risk population. After hospital discharge no death occurred during 30-day follow-up, one patient died during 1-year follow-up after PVL closure.

CONCLUSION: In this single-center series interventional PVL closure appears promising for patients at high surgical risk with symptomatic paravalvular regurgitation. Gaining experience in interventional PVL closure at specialized sites will further improve safety and efficacy of this relatively new treatment option. All patients should be treated within large clinical registries to gain more data on mid- and long-term efficacy of transcatheter PVL closure.