Author + information
- Received December 17, 2018
- Revision received January 14, 2019
- Accepted January 21, 2019
- Published online April 15, 2019.
- Georg Nickenig, MDa,∗ (, )@UniklinikBonn,
- Marcel Weber, MDa,
- Robert Schueler, MDa,
- Jörg Hausleiter, MDb,
- Michael Näbauer, MDb,
- Ralph S. von Bardeleben, MDc,
- Efthymios Sotiriou, MDc,
- Ulrich Schäfer, MDd,
- Florian Deuschl, MDd,
- Karl-Heinz Kuck, MDe,
- Felix Kreidel, MDe,
- Jean-Michel Juliard, MDf,g,h,
- Eric Brochet, MDf,g,h,
- Azeem Latib, MDi,
- Eustachio Agricola, MDi,
- Stephan Baldus, MDj,
- Kai Friedrichs, MDj,
- Prashanthi Vandrangi, PhDk,
- Patrick Verta, MS Stat, DVM, MDk,
- Rebecca T. Hahn, MDl and
- Francesco Maisano, MDm
- aDepartment of Cardiology, University Hospital Bonn, Bonn, Germany
- bLudwig-Maximilians University Hospital Munich, Munich, Germany
- cDepartment of Cardiology, University Medical Center Mainz, Mainz, Germany
- dStructural Heart Division, University Heart Center Hamburg, Hamburg, Germany
- eDepartment of Cardiology, St. George Hospital, Hamburg, Germany
- fDepartment of Cardiology, Hôpital Bichat, AP-HP, Paris, France
- gDépartement de Cardiologie, Université Paris-Diderot, Paris, France
- hINSERM U-1148, Paris, France
- iDipartimento Cardio-Toraco-Vascolare, San Raffaele Institute, Milan, Italy
- jHeart Center, University Hospital Cologne, Cologne, Germany
- kEdwards Lifesciences, Irvine, California
- lCardiovascular Research Foundation, New York, New York
- mDepartment of Cardiovascular Surgery, University Hospital Zurich, Zurich, Switzerland
- ↵∗Address for correspondence:
Prof. Georg Nickenig, Herzzentrum, Medizinische Klinik und Poliklinik II, Universitätsklinikum Bonn, Sigmund-Freud-Straße 25, Bonn 53127, Germany.
Background Severe tricuspid regurgitation (TR) is associated with high morbidity and mortality rates with limited treatment options.
Objectives The authors report the 6-month safety and performance of a transcatheter tricuspid valve reconstruction system in the treatment of moderate to severe functional TR in 30 patients enrolled in the TRI-REPAIR (TrIcuspid Regurgitation RePAIr With CaRdioband Transcatheter System) study.
Methods Between October 2016 and July 2017, 30 patients were enrolled in this single-arm, multicenter, prospective trial. Patients were diagnosed with moderate to severe, symptomatic TR in the absence of untreated left-heart disease and deemed inoperable because of unacceptable risk for open-heart surgery by the local heart team. Clinical, functional, and echocardiographic data were prospectively collected before and up to 6 months post-procedure. An independent core lab assessed all echocardiographic data, and an independent clinical event committee adjudicated the safety events.
Results Mean patient age was 75 years, 73% were female, and 23% had ischemic heart disease. At baseline, 83% were in New York Heart Association (NYHA) functional class III to IV, and mean left ventricular ejection fraction was 58%. Technical success was 100%. Through 6 months, 3 patients died. Between 6 months and baseline, echocardiography showed average reductions of annular septolateral diameter of 9% (42 mm vs. 38 mm; p < 0.01), proximal isovelocity surface area effective regurgitant orifice area of 50% (0.8 cm2 vs. 0.4 cm2; p < 0.01), and mean vena contracta width of 28% (1.2 cm vs. 0.9 cm; p < 0.01). Clinical assessment showed that 76% of patients improved by at least 1 NYHA functional class with 88% in NYHA functional class I or II. Six-minute walk distance improved by 60 m (p < 0.01), and Kansas City Cardiomyopathy Questionnaire score improved by 24 points (p < 0.01).
Conclusions Six-month outcomes show that the system performs as intended and appears to be safe in patients with symptomatic and moderate to severe functional TR. Significant reduction of TR through decrease of annular dimensions, improvements in heart failure symptoms, quality of life, and exercise capacity were observed. Further studies are warranted to validate these initial promising results. (TrIcuspid Regurgitation RePAIr With CaRdioband Transcatheter System [TRI-REPAIR]; NCT02981953)
Prof. Nickenig has received research funding from the Deutsche Forschungsgemeinschaft (DFG), the Federal Ministry of Education and Research (BMBF), The European Union, Abbott, AGA Medical, AstraZeneca, Bayer, Berlin Chemie, Biosensus, Biotronic, Bristol-Myers Squibb, Boehringer Ingelheim, Daiichi-Sankyo, Edwards Lifesciences, Medtronic, Novartis, Pfizer, Sanofi, and St. Jude Medical; has received honoraria for lectures or advisory boards from Abbott, AGA Medical, AstraZeneca, Bayer, Berlin, Cardiovalve, Berlin Chemie, Biosensus, Biotronic, Bristol-Myers Squibb, Boehringer Ingelheim, Daiichi-Sankyo, Edwards Lifesciences, Medtronic, Novartis, Pfizer, Sanofi, and St. Jude Medical; and has participated in clinical trials for Abbott, AGA Medical, AstraZeneca, Bayer, Berlin Chemie, Biosensus, Biotronic, Bristol-Myers Squibb, Boehringer Ingelheim, Cardiovalve, Daiichi-Sankyo, Edwards Lifesciences, Medtronic, Novartis, Pfizer, Sanofi, and St. Jude Medical. Dr. Schueler has received speaker honoraria from Edwards Lifesciences. Dr. Hausleiter has received research support and honoraria from Abbott Vascular and Edwards Lifesciences. Dr. Näbauer has received lecture fees and served on an advisory board for Abbott Vascular. Dr. Schäfer has received speaker honoraria as well as travel and grant support from Edwards Lifesciences. Dr. Deuschl has been a consultant and received speaker honoraria as well as travel and grant support from Edwards Lifesciences; has been a proctor for Cardioband and Edwards Lifesciences; and has been an employee of Edwards Lifesciences. Dr. Kuck has been a consultant for Medtronic, Abbott, Boston Scientific, Edwards Lifesciences, and Biosense Webster. Dr. Kreidel has received speaker honoraria from Valtech and Edwards Lifesciences. Dr. Brochet has received proctoring fees from Abbott. Dr. Latib has served on advisory boards for Medtronic and Abbott; and has been a consultant to Edwards Lifesciences. Dr. Agricola has received speaker honoraria from Edwards Lifesciences. Dr. Baldus has received speaker honoraria as well as travel and grant support from Edwards Lifesciences. Dr. Vandrangi is an employee of Edwards Lifesciences. Dr. Verta is an employee of and holds stock in Edwards Lifesciences. Dr. Hahn has been a speaker for Abbott Vascular, Boston Scientific, Bayliss, Edwards Lifesciences, Philips Healthcare, and Siemens Healthineers; has served as a consultant/on advisory boards for 3Mensio, Abbott Vascular, Edwards Lifesciences, GE Healthcare, Gore & Associates, Medtronic, Navigate, Philips Healthcare, and Siemens Healthineers; and has served as chief scientific officer for the echocardiography core laboratory at the Cardiovascular Research Foundation for multiple industry-sponsored trials for which she receives no direct industry compensation. Dr. Maisano has been a consultant for and received institutional grants from Valtech Cardo and for Edwards Lifesciences; is a shareholder of Valtech Cardo; and receives royalties from Edwards Lifesciences. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
Listen to this manuscript's audio summary by Editor-in-Chief Dr. Valentin Fuster on JACC.org.
- Received December 17, 2018.
- Revision received January 14, 2019.
- Accepted January 21, 2019.
- 2019 American College of Cardiology Foundation