Francesco Maisano1, Maurizio Taramasso2, Georg Nickenig3, Christoph Hammerstingl3, Alec Vahanian4, David Messika-Zeitoun4, Stephan Baldus5, Michael Huntgeburth5, Ottavio Alfieri6, Antonio Colombo6, Giovanni La Canna6, Eustachio Agricola6, Michel Zuber2, Felix C Tanner2, Yan Topilsky7, Felix Kreidel8, Karl-Heinz Kuck8. 1. Klinik für Herz- und Gefässchirurgie, University Hospital of Zurich, University of Zurich, Heart Center, Rämistrasse, 100, 8091 Zurich, Switzerland francesco.maisano@usz.ch. 2. Klinik für Herz- und Gefässchirurgie, University Hospital of Zurich, University of Zurich, Heart Center, Rämistrasse, 100, 8091 Zurich, Switzerland. 3. Department of Medicine II, Heart Center Bonn, University Hospital Bonn, Bonn, Germany. 4. Department of Cardiology, Assistance Publique-Hôpitaux de Paris, Bichat Hospital, Paris, France. 5. Department of Cardiology, Heart Center, University Hospital Cologne, Cologne, Germany. 6. Cardiovascular Department, San Raffaele University Hospital, Milan, Italy. 7. The Tel Aviv Sourasky Medical Center, Tel Aviv, Israel. 8. Division of Cardiology, Asklepios Klinik St. Georg Hospital, Hamburg, Germany.
Abstract
AIMS: Cardioband system is a direct annuloplasty adjustable device that is implanted in the beating heart on the posterior annulus under fluoroscopic and transoesophageal echocardiographic (TEE) guidance. We report the early (1 month) outcomes of the first-in-man pre-CE-mark feasibility and safety trial. METHODS AND RESULTS: The study enrolled high-risk adult individuals at five institutions in Europe with symptomatic secondary mitral regurgitation (MR) despite optimal medical therapy. The primary efficacy endpoints included the technical success rate of implantation, feasibility of the Cardioband adjustment (technical performance), and ability to reduce the annular septolateral dimension and MR grade at hospital discharge and at 30 days. The study group included 31 consecutively enrolled high-risk patients with moderate-to-severe or severe secondary MR with at least 1 month of follow-up (mean age 71.8 ± 6.9 years). All patients received the full implant of a Cardioband. Adjustment of the Cardioband resulted in a significant reduction in the septolateral dimension in all but two patients (septolateral dimension from 36.8 ± 4.8 to 29 ± 5.5 mm after the procedure, P < 0.01). Following Cardioband adjustment (29 of 31 patients) MR was none or trace in 6 (21%), mild in 21 (72%), and moderate in 2 (7%). No patient had severe MR after adjustment. Procedural mortality was zero and in-hospital mortality was 6.5% (2 of 31 patients, neither procedure- nor device-related). At 30 days, 22 of the 25 patients (88%) had MR ≤2+. CONCLUSIONS: This study demonstrates the feasibility and safety of percutaneous direct mitral annuloplasty with the Cardioband device in high-risk patients with MR. Published on behalf of the European Society of Cardiology. All rights reserved.
AIMS: Cardioband system is a direct annuloplasty adjustable device that is implanted in the beating heart on the posterior annulus under fluoroscopic and transoesophageal echocardiographic (TEE) guidance. We report the early (1 month) outcomes of the first-in-man pre-CE-mark feasibility and safety trial. METHODS AND RESULTS: The study enrolled high-risk adult individuals at five institutions in Europe with symptomatic secondary mitral regurgitation (MR) despite optimal medical therapy. The primary efficacy endpoints included the technical success rate of implantation, feasibility of the Cardioband adjustment (technical performance), and ability to reduce the annular septolateral dimension and MR grade at hospital discharge and at 30 days. The study group included 31 consecutively enrolled high-risk patients with moderate-to-severe or severe secondary MR with at least 1 month of follow-up (mean age 71.8 ± 6.9 years). All patients received the full implant of a Cardioband. Adjustment of the Cardioband resulted in a significant reduction in the septolateral dimension in all but two patients (septolateral dimension from 36.8 ± 4.8 to 29 ± 5.5 mm after the procedure, P < 0.01). Following Cardioband adjustment (29 of 31 patients) MR was none or trace in 6 (21%), mild in 21 (72%), and moderate in 2 (7%). No patient had severe MR after adjustment. Procedural mortality was zero and in-hospital mortality was 6.5% (2 of 31 patients, neither procedure- nor device-related). At 30 days, 22 of the 25 patients (88%) had MR ≤2+. CONCLUSIONS: This study demonstrates the feasibility and safety of percutaneous direct mitral annuloplasty with the Cardioband device in high-risk patients with MR. Published on behalf of the European Society of Cardiology. All rights reserved.
Authors: T Thielsen; C Frerker; T Schmidt; M Schlüter; F Kreidel; H Alessandrini; K-H Kuck Journal: Internist (Berl) Date: 2016-04 Impact factor: 0.743
Authors: Thilo Noack; Philipp Kiefer; Christian Besler; Philipp Lurz; Sergey Leontyev; Mohamed Abdel-Wahab; David Michael Holzhey; Joerg Seeburger Journal: Indian J Thorac Cardiovasc Surg Date: 2019-09-10