Header

UZH-Logo

Maintenance Infos

Transcatheter direct mitral annuloplasty with Cardioband: feasibility and efficacy trial in an acute preclinical model


Taramasso, Maurizio; Guidotti, Andrea; Cesarovic, Nikola; Denti, Paolo; Addis, Alessandro; Candreva, Alessandro; Nietlispach, Fabian; Fleischmann, Thea; Emmert, Maximilian Y; Maisano, Francesco (2016). Transcatheter direct mitral annuloplasty with Cardioband: feasibility and efficacy trial in an acute preclinical model. EuroIntervention, 12(11):e1428-e1434.

Abstract

AIMS The aim of the study was to report preclinical safety and feasibility of a new transcatheter direct mitral annuloplasty intervention in an acute animal model. METHODS AND RESULTS Twenty healthy pigs underwent Cardioband (Valtech Cardio, Or Yehuda, Israel) transcatheter implantation under intracardiac echocardiographic and fluoroscopic guidance. Through a neo inferior vena cava approach, transseptal access was arranged. The device was delivered into the left atrium using a multi-steerable catheter and fixed to the mitral annulus with multiple helix anchors. Following device cinching, reduction of annular size was evaluated. In all animals the device could be successfully implanted and displayed 100% function, with the average procedure duration and fluoroscopy times being 78±23 minutes and 27±9 minutes, respectively. In total, 246 anchors (average 12.3 per device) were delivered and optimal anchor placement was achieved in 95.1%, while inadequate anchor position (4%) and injury of the coronary sinus or atrium (0.8%) occurred in the rest. Following maximal cinching, diastolic transmitral flow velocity and coaptation lengths were markedly increased (p<0.001), whereas septolateral and intercommissural distances were significantly decreased (p<0.001), when compared to pre-contraction baseline, demonstrating efficient annular reduction by the device. CONCLUSIONS Transcatheter direct annuloplasty with a surgical-like adjustable device is feasible in the porcine animal model. The humanised porcine model has been instrumental in demonstrating feasibility and in establishing the procedural steps.

Abstract

AIMS The aim of the study was to report preclinical safety and feasibility of a new transcatheter direct mitral annuloplasty intervention in an acute animal model. METHODS AND RESULTS Twenty healthy pigs underwent Cardioband (Valtech Cardio, Or Yehuda, Israel) transcatheter implantation under intracardiac echocardiographic and fluoroscopic guidance. Through a neo inferior vena cava approach, transseptal access was arranged. The device was delivered into the left atrium using a multi-steerable catheter and fixed to the mitral annulus with multiple helix anchors. Following device cinching, reduction of annular size was evaluated. In all animals the device could be successfully implanted and displayed 100% function, with the average procedure duration and fluoroscopy times being 78±23 minutes and 27±9 minutes, respectively. In total, 246 anchors (average 12.3 per device) were delivered and optimal anchor placement was achieved in 95.1%, while inadequate anchor position (4%) and injury of the coronary sinus or atrium (0.8%) occurred in the rest. Following maximal cinching, diastolic transmitral flow velocity and coaptation lengths were markedly increased (p<0.001), whereas septolateral and intercommissural distances were significantly decreased (p<0.001), when compared to pre-contraction baseline, demonstrating efficient annular reduction by the device. CONCLUSIONS Transcatheter direct annuloplasty with a surgical-like adjustable device is feasible in the porcine animal model. The humanised porcine model has been instrumental in demonstrating feasibility and in establishing the procedural steps.

Statistics

Citations

1 citation in Web of Science®
2 citations in Scopus®
Google Scholar™

Altmetrics

Additional indexing

Item Type:Journal Article, refereed, original work
Communities & Collections:04 Faculty of Medicine > University Hospital Zurich > Clinic for Cardiovascular Surgery
Dewey Decimal Classification:610 Medicine & health
Language:English
Date:10 December 2016
Deposited On:07 Jan 2016 13:28
Last Modified:10 Dec 2016 02:00
Publisher:Europa Edition
ISSN:1774-024X
Free access at:Publisher DOI. An embargo period may apply.
Publisher DOI:https://doi.org/10.4244/EIJY15M11_06
PubMed ID:26573974

Download

Full text not available from this repository.
View at publisher