Aydin Yildirim1, Omer Goktekin2, Sevket Gorgulu3, Tugrul Norgaz4, Emre Akkaya1, Unal Aydin5, Hale Unal Aksu1, Ihsan Bakir5. 1. Cardiology Department, Mehmet Akif Ersoy Thoracic and Cardiovascular Surgery Training and Research Hospital, Istanbul, Turkey. 2. Cardiology Department, Bezmialem University Medical Faculty, Istanbul, Turkey. 3. Cardiology Department, Acibadem University Medical Faculty, Istanbul, Turkey. sevket5@yahoo.com. 4. Cardiology Department, Acibadem University Medical Faculty, Istanbul, Turkey. 5. Cardiovascular Surgery Department, Mehmet Akif Ersoy Chest and Cardiovascular Surgery Training and Research Hospital, Istanbul, Turkey.
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.
RCT Entities:
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.