Author + information
- Received March 29, 2018
- Revision received June 25, 2018
- Accepted July 3, 2018
- Published online November 19, 2018.
- Josep Rodés-Cabau, MDa,∗ (, )
- Mathieu Bernier, MDa,
- Ignacio J. Amat-Santos, MD, PhDb,
- Tuvia Ben Gal, MDc,
- Luis Nombela-Franco, MD, PhDd,
- Bruno García del Blanco, MDe,
- Arthur Kerner, MDf,
- Sebastien Bergeron, MDa,
- Maria del Trigo, MD, PhDa,
- Philippe Pibarot, PhDa,
- Sergio Shkurovich, PhDg,
- Neal Eigler, MDg and
- William T. Abraham, MDh
- aQuebec Heart and Lung Institute, Quebec City, Quebec, Canada
- bHospital Clínico Universitario de Valladolid, Valladolid, Spain
- cRabin Medical Center, Petah Tikva, Israel
- dInstituto Cardiovascular, Hospital Clínico San Carlos, Instituto de Investigación Sanitaria del Hospital Clínico San Carlos (IdISSC), Madrid, Spain
- eHospital Universitari Vall d’ Hebron, Barcelona, Spain
- fRambam Medical Center, Haifa, Israel
- gV-Wave, Caesarea, Israel
- hOhio State University Medical Center, Columbus, Ohio
- ↵∗Address for correspondence:
Dr. Josep Rodés-Cabau, Quebec Heart & Lung Institute, Laval University, 2725 Chemin Ste-Foy, Quebec City QC G1V 4G5, Canada.
Objectives This was a first-in-human study to assess the feasibility, safety, and exploratory efficacy of interatrial shunting for treating high-risk heart failure (HF) in patients with reduced and preserved ejection fraction.
Methods A single-arm open-label study of patients with New York Heart Association functional class III or IV HF on optimal therapy was performed at 6 centers. The V-Wave shunt, an hourglass-shaped implant containing a 1-way bioprosthetic valve, was implanted by transseptal catheterization. Clinical, functional, echocardiographic, and hemodynamic evaluations were performed at baseline, 3 and 12 months, and annually (clinical follow-up) thereafter (median follow-up 28 months; interquartile range: 21 to 31 months).
Results A total of 38 patients were enrolled (30 with HF with reduced ejection fraction and 8 with HF with preserved ejection fraction; mean age 66 ± 9 years; 97% and 3% in New York Heart Association functional classes III and IV, respectively), and the shunt device was successfully implanted in all cases without periprocedural mortality. The rate of major device- or procedure-related complications during the first 12 months was 2.6% (periprocedural cardiac tamponade in 1 patient). At 3- and 12-month follow-up, there were improvements in New York Heart Association functional class (classes I and II in 78% and 60% of patients, respectively), quality of life (improvements ≥5 points in 74% and 73% of patients, respectively), and 6-min walk distance (mean increases of 41 ± 63 m and 28 ± 83 m, respectively) (p < 0.02 for all, data available for 36 patients), without changes in objective measures of left- or right-sided function. All shunts were patent at 3 months, but 5 of 36 (14%) had occluded, and another 13 of 36 (36%) were stenotic at the valve by 12 months. Patients with widely patent shunts had lower long-term rates of death, left ventricular assist device placement or heart transplantation (p = 0.001), and HF hospitalization (p = 0.008), along with a reduction of pulmonary capillary wedge pressure (from 23.3 ± 5.4 mm Hg at baseline to 18.0 ± 4.0 mm Hg at 12 months; p = 0.011).
Conclusions Interatrial shunting with the V-Wave system was feasible and safe in patients with HF with reduced and preserved ejection fraction. Improvements in clinical and functional status were observed early and at 12 months despite attenuation of shunt patency in one-half of the patients. Patients with preserved shunt patency tended to maintain clinical benefit during longer term follow-up. Device modification that improves the durability of patency is likely worthwhile before confirmation of these findings in a randomized trial.
Drs. Shkurovich, Eigler, and Abraham are corporate officers for the study sponsor, V-Wave, and receive salary compensation and have equity interest. Dr. Rodés-Cabau is a consultant for and has received institutional research grants from V-Wave; and holds the Canadian Research Chair “Fondation Famille Jacques Larivière” for the Development of Structural Heart Disease Interventions. Drs. Bernier, Amat-Santos, Ben Gal, Nombela-Franco, García del Blanco, Kerner, Bergeron, and Pibarot have investigator agreements with V-Wave through their contracting institutions. Dr. del Trigo has reported that she has no relationships relevant to the contents of this paper to disclose.
- Received March 29, 2018.
- Revision received June 25, 2018.
- Accepted July 3, 2018.
- 2018 American College of Cardiology Foundation
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