Author + information
- Received May 16, 2017
- Accepted June 1, 2017
- Published online August 21, 2017.
- Marco Barbanti, MDa,∗ (, )
- Nicolò Piazza, MDb,
- Sarah Mangiafico, MDa,
- Jean Buithieu, MDb,
- Sabine Bleiziffer, MDc,
- Giuseppe Ronsivalle, MDa,
- Salvatore Scandura, MDa,
- Angelo Giuffrida, MDa,
- Antonio Popolo Rubbio, MDa,
- Massimo Mazzamuto, MDa,
- Carmelo Sgroi, MDa,
- Rüdiger Lange, MDc and
- Corrado Tamburino, MD, PhDa
- aFerrarotto Hospital, University of Catania, Catania, Italy
- bMcGill University Health Center, Montreal, Québec, Canada
- cGerman Heart Center Munich, Technical University Munich, Munich, Germany
- ↵∗Address for correspondence:
Dr. Marco Barbanti, Division of Cardiology, Ferrarotto Hospital, University of Catania, via Citelli 6, 95124 Catania, Italy.
Objectives This study is the first report of 2 cases of HighLife (HighLife, Paris, France) implantation in humans.
Background Transcatheter mitral valve implantation represents a promising approach to treating mitral regurgitation in patients at increased risk of perioperative mortality. The HighLife transcatheter mitral valve is a 2-component system. The valve is implanted in the mitral position and is anchored by interacting and then reaching an equilibrium position with a previously positioned subannular implant.
Methods The procedures were successfully performed in a 69-year-old man and a 65-year-old woman with severe functional mitral regurgitation. Both patients were in New York Heart Association functional class IV heart failure with depressed left ventricular ejection fraction and additional comorbidities.
Results The valve was implanted uneventfully in both patients. General anesthesia was used. The subannular implant was deployed through the transfemoral access, whereas the transcatheter mitral valve was released using the transapical access. Patients maintained hemodynamically stable. There were no intraoperative complications. Acutely, post-procedural echocardiograms demonstrated excellent prosthetic valve function with a low transvalvular gradient and no paravalvular leak and left ventricular outflow tract obstruction. Both patients had mild intraprosthetic regurgitation. Patient #1 survived at 5-months follow-up in New York Heart Association functional class II with excellent prosthesis performance. Patient #2 expired 4 days after a technically successful procedure, because the left ventricle did not tolerate the reduction of mitral regurgitation and despite a high dose of inotropic agents the left ventricular function rapidly deteriorated.
Conclusions Transcatheter mitral valve implantation using the 2-component HighLife system is technically feasible and can be performed safely. Early hemodynamic performance of the prosthesis was excellent.
Dr. Piazza is a consultant and proctor to HighLife and Medtronic; and has consultant equity shares in HighLife. Dr. Buithieu is a consultant to HighLife; and has received consultant fees from HighLife. Dr. Bleiziffer is a consultant for HighLife. Dr. Lange is a consultant for Medtronic, LivaNova, St. Jude Medical/Abbott Vascular, and HighLife; and has an equity share in HighLife. Dr. Tamburino received speaker honoraria from Abbott Vascular, Medtronic, Symetis, Stentys, and Biosensors. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose. Drs. Barbanti and Piazza equally contributed to this work.
- Received May 16, 2017.
- Accepted June 1, 2017.
- 2017 American College of Cardiology Foundation