Percutaneous Device Closure of Paravalvular Leak: Combined Experience from the United Kingdom and Ireland
Background—Paravalvular leak (PVL) occurs in 5-17% of patients following surgical valve replacement. Percutaneous device closure represents an alternative to repeat surgery.
Methods—All UK and Ireland centers undertaking percutaneous PVL closure submitted data to the UK PVL Registry. Data was analyzed for association with death and major adverse cardiovascular events (MACE) at follow up.
Results—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 TAVR (5%). Pre-procedural 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 NYHA 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 (HR=1.83, p=0.011). Factors independently associated with death were the degree of persisting leak (HR=2.87, p=0.037), NYHA (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).
Conclusions—Percutaneous closure of PVL is an effective procedure which improves PVL severity and symptoms. Severity of persisting leak at follow-up is independently associated with both MACE and death. Percutaneous closure should be considered as an alternative to repeat surgery.
- Received March 24, 2016.
- Revision received July 27, 2016.
- Accepted August 5, 2016.