Transapical treatment of paravalvular leaks in patients with a logistic EuroSCORE of more than 15%: acute and 3-month outcomes of a "proof of concept" study.

OBJECTIVE: We describe the short-term results of the patients who underwent transapical treatment of a paravalvular leak (PVL) in our centre.

BACKGROUND: Increasing experience with transapical aortic valve implantation has inspired us to explore this approach for prosthetic paravalvular leak reduction in high risk patients.

METHODS: All procedures were performed in the catheterization laboratory under general anesthesia, using a small anterolateral thoracotomy to expose the apex. Access through a 9-French sheath was necessary to introduce the Amplatzer Vascular III plug. Three-dimensional transesophageal echocardiography (3D-TEE) was used to guide the operator and evaluate the severity of regurgitation postimplantation.

RESULTS: In total seven consecutive patients (mean age 72.8 ± 5.6 years, 86% male) with a history of mitral valve (n = 6) or aortic valve replacement and severe PVL, underwent transapical PVL reduction using seven plugs in total (diameter 10-14 mm). Preprocedural median logistic EuroSCORE was 28.5% (range 17.1-41.1%) and NYHA functional class was ≥3 in all patients. The procedure was successful in all patients, with a median fluoroscopic time of 18.7 min (range 10.1-29.6 min). Postprocedure 3D-TEE showed occlusion of PVL in three patients, and significant reduction in three patients. Postprocedural complication was a hematothorax requiring surgery in one patient. Median hospitalization duration after the procedure was 5 days (range 5-59 days). At 3-month follow-up one patient died, functional class and LDH did not differ significantly and there was a significant increase in hemoglobin.

CONCLUSIONS: Transapical paravalvular leak reduction might be a good or rather attractive alternative in high-risk patients for major re-do cardiac surgery.