Mid-term Procedural and Clinical Outcomes of Percutaneous Paravalvular Leak Closure With the Occlutech Paravalvular Leak Device.

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.