AIMS: To assess the efficacy and safety of the Occlutech Paravalvular Leak Device (PLD) for the percutaneous closure of paravalvular leaks (PVL).
METHODS AND RESULTS: Patients with PVL were enrolled at 21 sites from 9 countries. Indications for PVL closure were heart failure and/or hemolytic anemia. Endpoint measures were changes in PV regurgitation grade, NYHA class and requirement for hemolysis-related transfusion. One-hundred thirty-six patients with mitral (67.6%) or aortic (32.4%) leaks were included (mean age 66.7 years, 58% men). Thirty-one percent had multiple PVLs. The proportion of patients with NYHA III/IV decreased from 77.3% at baseline to 16.9% at latest follow-up. The proportion of patients with need for hemolysis-related blood transfusion decreased from 36.8% to 5.9% and 8.3% to 0% for ML patients and AL patients, respectively. All cause mortality was 7.4%. Complications included interference with valve leaflets (0.7%), transient device embolization (percutaneously solved) (0.7%), late device embolization (0.7%), recurrent hemolytic anemia (2.2%), new onset hemolytic anemia (0.7%), valve surgery (2.2%), need for repeat closure (0.7%), complications at femoral puncture site (0.7%) and arrythmias requiring treatment (4.4%).
CONCLUSIONS: PVL closure with the Occlutech PLD demonstrated high success rate associated with significant clinical improvement and a relatively low rate of serious complications.