A New Specific Device in Transcatheter Prosthetic Paravalvular Leak Closure: A Prospective Two-Center Trial.

ABSTRACT

BACKGROUND: This study sought to compare various outcomes among a new specifically designed transcatheter paravalvular leak closure (TPVLC) device and the devices that are being utilized off-label. METHODS: Between April 2012 and January 2015, in a prospective two-center study, 52 patients who needed surgical reintervention due to a hemodynamically significant prosthetic paravalvular leak were studied. This study population was divided into two groups. Group I was composed of 32 patients who underwent paravalvular leak (PVL) closure with the currently available devices that are being utilized off-label, while group II consisted of 20 patients who were treated with the new specifically designed Occlutech PVL device. RESULTS: Demographic and clinical variables indicated a higher rate of atrial fibrillation (P = 0.027) and chronic obstructive airway disease (P = 0.009) in group II. The apical approach was the most commonly used intervention route used for group II (P = 0.019). The procedural success rate was 100% (29 of 29 leaks) in group II while the rate was 92% (39 of 42 leaks) in group I. However, more secondary events were observed in group I, but they did not reach statistical significance (8 vs. 1, P = 0.064). CONCLUSIONS: With its high procedural success rate and encouraging outcome results, the Occlutech device seems to satisfy the expectations of a specifically designed PVL closure device. © 2016 Wiley Periodicals, Inc.