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. 2023 Jan 9;16(1):94-102.
doi: 10.1016/j.jcin.2022.10.050.

First-in-Human Dedicated Leaflet Splitting Device for Prevention of Coronary Obstruction in Transcatheter Aortic Valve Replacement

Danny Dvir  1 , Martin B Leon  2 , Mohamed Abdel-Wahab  3 , Axel Unbehaun  4 , Susheel Kodali  5 , Didier Tchetche  6 , Philippe Pibarot  7 , Jonathon Leipsic  8 , Philipp Blanke  8 , Ulrich Gerckens  9 , Ganesh Manoharan  10 , Emanuel Harari  11 , Elias Hellou  12 , Arik Wolak  13 , Eyal Ben-Assa  14 , Rami Jubeh  12 , Mony Shuvy  13 , Edward Koifman  15 , Christoph Klein  4 , Joerg Kempfert  4
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Free article

First-in-Human Dedicated Leaflet Splitting Device for Prevention of Coronary Obstruction in Transcatheter Aortic Valve Replacement

Danny Dvir et al. JACC Cardiovasc Interv. .
Free article

Abstract

Background: Coronary artery obstruction is a life-threatening complication of transcatheter aortic valve replacement (TAVR) procedures. Current preventive strategies are suboptimal.

Objectives: The aim of this study was to describe bench testing and clinical experience with a novel device that splits valve leaflets that are at risk for causing coronary obstruction after TAVR, allowing normal coronary flow.

Methods: The ShortCut device was initially tested in vitro and preclinically in a porcine model for functionality and safety. The device was subsequently offered to patients at elevated risk for coronary obstruction. Risk for coronary obstruction was based on computed tomography-based anatomical characteristics. Procedure success was determined as patient survival at 30 days with a functioning new valve, without stroke or coronary obstruction.

Results: Following a successful completion of bench testing and preclinical trial, the device was used in 8 patients with failed bioprosthetic valves (median age 81 years; IQR: 72-85 years; 37.5% man) at 2 medical centers. A total of 11 leaflets were split: 5 patients (63.5%) were considered at risk for left main obstruction alone, and 3 patients (37.5%) were at risk for double coronary obstruction. All patients underwent successful TAVR without evidence of coronary obstruction. All patients were discharged from the hospital in good clinical condition, and no adverse neurologic events were noted. Procedure success was 100%.

Conclusions: Evaluation of the first dedicated transcatheter leaflet-splitting device shows that the device can successfully split degenerated bioprosthetic valve leaflets. The procedure was safe and successfully prevented coronary obstruction in patients at risk for this complication following TAVR.

Keywords: coronary artery obstruction; structural heart disease; transcatheter aortic valve replacement; valve-in-valve.

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Conflict of interest statement

Funding Support and Author Disclosures Dr Dvir is a consultant to Edwards Lifesciences, Medtronic, Abbott, and Pi-Cardia. Dr Leon has received institutional clinical research grants from Abbott, Boston Scientific, Edwards Lifesciences, and Medtronic; and is a consultant and member of the steering committee for Pi-Cardia, with direct compensation in the form of stock options that can be exercised in the future. Dr Pibarot has received funding from Edwards Lifesciences, Medtronic, Pi-Cardia, and Cardiac Phoenix for echocardiography core laboratory analyses and research studies in the field of transcatheter valve therapies, for which he received no personal compensation. Dr Leipsic has provided computed tomography core laboratory services to Pi-Cardia. Dr Gerckens has received honoraria for clinical proctoring and/or consultancy fees from Medtronic, Boston Scientific, and Pi-Cardia. Dr Manoharan is a consultant and proctor for Medtronic, Abbott Medical, and Pi-Cardia. Dr Abdel-Wahab’s hospital has received speaker honoraria and/or consultancy fees on his behalf from Medtronic and Boston Scientific. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.

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