TY - JOUR
T1 - Percutaneous repair of the tricuspid valve using a novel cinching device
T2 - Acute and chronic experience in a preclinical large animal model
AU - Taramasso, Maurizio
AU - Latib, Azeem
AU - Denti, Paolo
AU - Nietlispach, Fabian
AU - Lynn, Kevin
AU - Cesarovic, Nikola
AU - Addis, Alessandro
AU - Emmert, Maximilian Y.
AU - Guidotti, Andrea
AU - Vanermen, Hugo
AU - Maisano, Francesco
N1 - Publisher Copyright:
© 2016 Europa Digital & Publishing. All rights reserved.
PY - 2016/9
Y1 - 2016/9
N2 - Aims: The aim of this study was to evaluate the safety, technical feasibility and performance of a new transcatheter tricuspid repair system. Methods and results: Thirty-one adult swine underwent implantation of a transcatheter tricuspid remodelling system under general anaesthesia. The steerable transcatheter device was introduced through a 24 Fr femoral sheath into the right femoral vein and delivered to the tricuspid annulus on the beating heart. A fixation element was implanted into the tricuspid annulus. Following implantation, a second delivery system was used to couple the fixation element with a self-expanding nitinol stent. The device was tensioned to reshape the tricuspid valve and increase the coaptation length of the valve leaflets under echo guidance. Finally, the stent was deployed in the inferior vena cava (IVC) to maintain the tension applied. The transcatheter device was successfully implanted in all animals (n=31). Doppler echocardiography prior to sacrifice showed that tricuspid valve function was stable and normal tricuspid leaflet motion was observed. Cinching of the tricuspid annulus resulted in an increase of leaflet coaptation length of 70% (4.5±0.7 mm to 7.78±1.3 mm), an increase in trans-tricuspid peak velocity of 79% (0.38±0.1 m/s to 0.68±0.1 m/s), and a reduction in septolateral tricuspid valve dimension of 30% (35.2±5 mm to 24.8±5 mm). At necropsy, the fixation element was firmly attached to the annulus within a fibrotic tissue, with no coronary lesions observed and no abnormality visible. The stent was fully deployed in the IVC, without displacement or change in the stent shape. Conclusions: Percutaneous beating heart remodelling of the tricuspid annulus with a cinching device is safe and feasible.
AB - Aims: The aim of this study was to evaluate the safety, technical feasibility and performance of a new transcatheter tricuspid repair system. Methods and results: Thirty-one adult swine underwent implantation of a transcatheter tricuspid remodelling system under general anaesthesia. The steerable transcatheter device was introduced through a 24 Fr femoral sheath into the right femoral vein and delivered to the tricuspid annulus on the beating heart. A fixation element was implanted into the tricuspid annulus. Following implantation, a second delivery system was used to couple the fixation element with a self-expanding nitinol stent. The device was tensioned to reshape the tricuspid valve and increase the coaptation length of the valve leaflets under echo guidance. Finally, the stent was deployed in the inferior vena cava (IVC) to maintain the tension applied. The transcatheter device was successfully implanted in all animals (n=31). Doppler echocardiography prior to sacrifice showed that tricuspid valve function was stable and normal tricuspid leaflet motion was observed. Cinching of the tricuspid annulus resulted in an increase of leaflet coaptation length of 70% (4.5±0.7 mm to 7.78±1.3 mm), an increase in trans-tricuspid peak velocity of 79% (0.38±0.1 m/s to 0.68±0.1 m/s), and a reduction in septolateral tricuspid valve dimension of 30% (35.2±5 mm to 24.8±5 mm). At necropsy, the fixation element was firmly attached to the annulus within a fibrotic tissue, with no coronary lesions observed and no abnormality visible. The stent was fully deployed in the IVC, without displacement or change in the stent shape. Conclusions: Percutaneous beating heart remodelling of the tricuspid annulus with a cinching device is safe and feasible.
KW - Preclinical
KW - Transcatheter tricuspid repair
KW - Tricuspid regurgitation
KW - Tricuspid valve
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U2 - 10.4244/EIJV12I7A150
DO - 10.4244/EIJV12I7A150
M3 - Article
C2 - 27639745
AN - SCOPUS:84990946997
SN - 1774-024X
VL - 12
SP - 918
EP - 925
JO - EuroIntervention
JF - EuroIntervention
IS - 7
ER -