Author + information
- Received April 25, 2016
- Revision received June 27, 2016
- Accepted June 30, 2016
- Published online October 10, 2016.
- Georg Nickenig, MDa,∗ (, )
- Christoph Hammerstingl, MDa,
- Robert Schueler, MDa,
- Yan Topilsky, MDb,
- Paul A. Grayburn, MDc,
- Alec Vahanian, MDd,
- David Messika-Zeitoun, MDd,
- Marina Urena Alcazar, MDd,
- Stephan Baldus, MDe,
- Rudolph Volker, MDe,
- Michael Huntgeburth, MDe,
- Ottavio Alfieri, MDf,
- Azeem Latib, MDf,
- Giovanni La Canna, MDf,
- Eustachio Agricola, MDf,
- Antonio Colombo, MDg,h,
- Karl-Heinz Kuck, MDi,
- Felix Kreidel, MDi,
- Christian Frerker, MDi,
- Felix C. Tanner, MDj,
- Ori Ben-Yehuda, MDk and
- Francesco Maisano, MDj
- aDepartment of Cardiology, Heart Center Bonn, University Hospital Bonn, Bonn, Germany
- bThe Tel-Aviv Sourasky Medical Center, Tel-Aviv, Israel
- cBaylor Health, Dallas, Texas
- dBichat Claude Bernard Hospital-Paris VII University, Paris, France
- eHeart Center, University of Cologne, Cologne, Germany
- fSan Raffaele University Hospital, Milan, Italy
- gInterventional Cardiology Unit, EMO-GVM Centro Cuore Columbus, Milan, Italy
- hInterventional Cardiology Unit, San Raffaele Scientific Institute, Milan, Italy
- iDepartment of Cardiology, Asklepios Klinik St. Georg Hospital, Hamburg, Germany
- jValve Clinic, University Heart Center, University Hospital Zürich, Zürich, Switzerland
- kCardiovascular Research Foundation and Columbia University, New York, New York
- ↵∗Reprint requests and correspondence:
Dr. Georg Nickenig, Department of Cardiology, Heart Center Bonn, University Hospital Bonn, Sigmund-Freud-Straße 25, Bonn 53105, Germany.
Objectives This study sought to show safety and efficacy of the Cardioband system during 6 months after treatment.
Background Current surgical and medical treatment options for functional mitral regurgitation (FMR) are limited. The Cardioband system (Valtech Cardio, OrYehuda, Israel) is a novel transvenous, transseptal direct annuloplasty device.
Methods Thirty-one patients (71.8 ± 6.9 years of age; 83.9% male; EuroSCORE II: 8.6 ± 5.9) with moderate to severe FMR, symptomatic heart failure, and depressed left ventricular function (left ventricular ejection fraction 34 ± 11%) were prospectively enrolled.
Results Procedural success rate, defined as delivery of the entire device, was 100%. There were no periprocedural deaths (0%), and mortality rate at 1 month or prior to hospital discharge and at 7 months was 5% and 9.7% respectively. Cinching of the implanted Cardioband reduced the annular septolateral dimension by >30% from 3.7 ± 0.5 cm at baseline to 2.5 ± 0.4 cm after 1 month and to 2.4 ± 0.4 cm after 6 months, respectively (p < 0.001). Percentage of patients with FMR ≥3 was reduced from 77.4% to 10.7% 1 month after the procedure (p < 0.001) and 13.6% (p < 0.001) at 7 months. Percentage of patients with New York Heart Association functional class III/IV decreased from 95.5% to 18.2% after 7 months (p < 0.001); exercise capacity as assessed by 6-min walking test increased from 250 ± 107 m to 332 ± 118 m (p < 0.001) and quality of life (Minnesota Living With Heart Failure Questionnaire) was also significantly improved (p < 0.001).
Conclusions In this feasibility trial in symptomatic patients with FMR, transcatheter mitral annuloplasty with the Cardioband was effective in reducing MR and was associated with improvement in heart failure symptoms and demonstrated a favorable safety profile. (Cardioband With Transfemoral Delivery System; NCT01841554)
Dr. Hammerstingl has received speaker honoraria from Valtech Cardio. Dr. Topilsky has served as a consultant for Valtech Cardio. Dr. Grayburn has received research grants from Abbott Vascular, Medtronic, Boston Scientific, Edwards Lifesciences, and Teva; has served as a consultant for Abbott Vascular, Tendyne, Neochord, and Valtech Cardio; and has echo core lab contracts with Neochord and Valtech Cardio. Dr. Vahanian has served as a consultant for Edwards Lifesciences and Abbott Vascular; and has received research grant support from Valtech Cardio. Dr. Messika-Zeitoun has served as a proctor for Valtech Cardio; and has received research grant support from Abbott Vascular and Edwards Lifesciences. Dr. Volker has received speaker fees from Valtech Cardio. Dr. Latib has served on the advisory board for Medtronic and Millipede; and as a consultant for Direct Flow Medical. Dr. Kuck has served as a consultant for St. Jude Medical, Abbott Vascular, and Medtronic. Dr. Kreidel has served as a consultant for Valtech Cardio. Dr. Ben-Yehuda has received research grant support from Valtech Cardio. Dr. Maisano has served as a consultant for Valtech Cardio, Abbott Vascular, Medtronic, Edwards Lifesciences, and St. Jude Medical; he is the co-founder of Valtech Cardio; and has received royalties from Edwards Lifesciences. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose. Drs. Nickenig and Hammerstingl contributed equally to this work.
- Received April 25, 2016.
- Revision received June 27, 2016.
- Accepted June 30, 2016.
- American College of Cardiology Foundation