Percutaneous Device Closure of Paravalvular Leak
What are the outcomes with percutaneous paravalvular leak (PVL) closure?
All United Kingdom and Ireland centers undertaking percutaneous PVL closure submitted data to the UK PVL Registry. Data were analyzed for association with death and major adverse cardiovascular events (MACE) at follow-up. Clinical and procedural variables were tested for an association with death and MACE during follow-up using univariable Cox proportional hazard regression.
A total of 308 PVL closure procedures were attempted in 259 patients in 20 centers (2004-2015). Patient age was 67 ± 13 years; 28% were female. The main indications for closure were heart failure (80%) and hemolysis (16%). Devices were successfully implanted in 91% of patients, via radial (7%), femoral arterial (52%), femoral venous (33%), and apical (7%) approaches; 19% of patients required repeat procedures. The target valve was mitral (44%), aortic (48%), both (2%), pulmonic (0.4%), or transcatheter aortic valve replacement (5%). Preprocedural leak was severe (61%), moderate (34%), or mild (5.7%) and was multiple in 37%. PVL improved post-procedure (p < 0.001) and was none (33.3%), mild (41.4%), moderate (18.6%), or severe (6.7%) at last follow-up. Mean New York Heart Association (NYHA) class improved from 2.7 ± 0.8 pre-procedure to 1.6 ± 0.8 (p < 0.001) after a median follow-up of 110 [7-452] days. Hospital mortality was 2.9% (elective), 6.8% (in-hospital urgent), and 50% (emergency) (p < 0.001). MACE during follow-up included death (16%), valve surgery (6%), late device embolization (0.4%), and new hemolysis requiring transfusion (1.6%). Mitral PVL was associated with higher MACE (hazard ratio [HR], 1.83; p = 0.011). Factors independently associated with death were the degree of persisting leak (HR, 2.87; p = 0.037), NYHA class (HR, 2.00; p = 0.015) at follow-up, and baseline creatinine (HR, 8.19; p = 0.001). The only factor independently associated with MACE was the degree of persisting leak at follow-up (HR, 3.01; p = 0.002).
The authors concluded that percutaneous closure of PVL is an effective procedure, which improves PVL severity and symptoms.
This study reports that percutaneous device closure of PVL represents an effective approach to tackling a difficult problem in a high-risk cohort and compares favorably with results from surgical series. Use of oblong devices (not currently Food and Drug Administration approved) was key in the evolution of this procedure in the United Kingdom and Ireland. However, despite significant improvements in symptoms and leak severity, these patients have a poor long-term prognosis, which probably reflects their comorbidities. Overall, it appears that percutaneous device closure of PVL may be considered in those with suitable anatomy and in the absence of infective endocarditis. Additional prospective studies are indicated to define the optimal device and approach to paravalvular leak.
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