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A New Specific Device in Transcatheter Prosthetic Paravalvular Leak Closure: A Prospective Two‐Center Trial
Author(s) -
Yildirim Aydin,
Goktekin Omer,
Gorgulu Sevket,
Norgaz Tugrul,
Akkaya Emre,
Aydin Unal,
Unal Aksu Hale,
Bakir Ihsan
Publication year - 2016
Publication title -
catheterization and cardiovascular interventions
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.988
H-Index - 116
eISSN - 1522-726X
pISSN - 1522-1946
DOI - 10.1002/ccd.26439
Subject(s) - medicine , leak , single center , surgery , atrial fibrillation , prospective cohort study , statistical significance , cardiology , environmental engineering , engineering
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.