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

Danny Dvir, Martin B. Leon, Mohamed Abdel-Wahab, Axel Unbehaun, Susheel Kodali, Didier Tchetche, Philippe Pibarot, Jonathon Leipsic, Philipp Blanke, Ulrich Gerckens, Ganesh Manoharan, Emanuel Harari, Elias Hellou, Arik Wolak, Eyal Ben-Assa, Rami Jubeh, Mony Shuvy, Edward Koifman, Christoph Klein, Joerg Kempfert

Research output: Contribution to journalArticlepeer-review

19 Scopus citations

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.

Original languageEnglish
Pages (from-to)94-102
Number of pages9
JournalJACC: Cardiovascular Interventions
Volume16
Issue number1
DOIs
StatePublished - 9 Jan 2023
Externally publishedYes

Keywords

  • coronary artery obstruction
  • structural heart disease
  • transcatheter aortic valve replacement
  • valve-in-valve

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine

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