M J M Silvis1, M Dekker2,3, C Zivelonghi4, P Agostoni4, P R Stella1, P A Doevendans1,5,6, D P V de Kleijn2,5, J P van Kuijk7, G E Leenders1, L Timmers8. 1. Department of Cardiology, University Medical Centre Utrecht, Utrecht, The Netherlands. 2. Department of Vascular Surgery, University Medical Centre Utrecht, Utrecht, The Netherlands. 3. Department of Cardiology, Amsterdam UMC, University of Amsterdam, Amsterdam Cardiovascular Sciences, Amsterdam, The Netherlands. 4. Hart Centrum, Ziekenhuis Netwerk Antwerpen (ZNA) Middelheim, Antwerpen, Belgium. 5. Netherlands Heart Institute, Utrecht, The Netherlands. 6. Central Military Hospital, Utrecht, University Medical Center Utrecht, Utrecht, The Netherlands. 7. Department of Cardiology, St. Antonius Hospital Nieuwegein, Nieuwegein, The Netherlands. 8. Department of Cardiology, St. Antonius Hospital Nieuwegein, Nieuwegein, The Netherlands. l.timmers@antoniusziekenhuis.nl.
Abstract
BACKGROUND: Refractory angina is a growing and major health-care problem affecting millions of patients with coronary artery disease worldwide. The Coronary Sinus Reducer (CSR) is a device that may be considered for the relief of symptoms of refractory angina. It causes increased venous pressure leading to a dilatation of arterioles and reduced arterial vascular resistance in the sub-endocardium. This study describes the 5‑year Dutch experience regarding safety and efficacy of the CSR. METHODS: One hundred and thirty-two patients with refractory angina were treated with the CSR. The primary efficacy endpoint of the study was Canadian Cardiovascular Society (CCS) class improvement between baseline and 6‑month follow-up. The primary safety endpoint was successful CSR implantation in the absence of any device-related events. RESULTS: Eighty-five patients (67%) showed improvement of at least 1 CCS class and 43 patients (34%) of at least 2 classes. Mean CCS class improved from 3.17 ± 0.61 to 2.12 ± 1.07 after implantation (P < 0.001). The CSR was successfully implanted in 99% of the patients and only minor complications during implantation were reported. CONCLUSION: The CSR is a simple, safe, and effective option for most patients with refractory angina. However, approximately thirty percent of the patients showed no benefit after implantation. Future studies should focus on the exact underlying mechanisms of action and reasons for non-response to better identify patients that could benefit most from this therapy.
BACKGROUND:Refractory angina is a growing and major health-care problem affecting millions of patients with coronary artery disease worldwide. The Coronary Sinus Reducer (CSR) is a device that may be considered for the relief of symptoms of refractory angina. It causes increased venous pressure leading to a dilatation of arterioles and reduced arterial vascular resistance in the sub-endocardium. This study describes the 5‑year Dutch experience regarding safety and efficacy of the CSR. METHODS: One hundred and thirty-two patients with refractory angina were treated with the CSR. The primary efficacy endpoint of the study was Canadian Cardiovascular Society (CCS) class improvement between baseline and 6‑month follow-up. The primary safety endpoint was successful CSR implantation in the absence of any device-related events. RESULTS: Eighty-five patients (67%) showed improvement of at least 1 CCS class and 43 patients (34%) of at least 2 classes. Mean CCS class improved from 3.17 ± 0.61 to 2.12 ± 1.07 after implantation (P < 0.001). The CSR was successfully implanted in 99% of the patients and only minor complications during implantation were reported. CONCLUSION: The CSR is a simple, safe, and effective option for most patients with refractory angina. However, approximately thirty percent of the patients showed no benefit after implantation. Future studies should focus on the exact underlying mechanisms of action and reasons for non-response to better identify patients that could benefit most from this therapy.
Authors: C Mannheimer; P Camici; M R Chester; A Collins; M DeJongste; T Eliasson; F Follath; I Hellemans; J Herlitz; T Lüscher; M Pasic; D Thelle Journal: Eur Heart J Date: 2002-03 Impact factor: 29.983
Authors: Carlo Zivelonghi; Stefan Verheye; Leo Timmers; Jan Peter van Kuijk; Francesco Giannini; Mirthe Dekker; Max Silvis; Masieh Abawi; Geert Leenders; Friso Kortland; Giorgos Tzanis; Alessandro Beneduce; Giovanni Benfari; Pieter Stella; Josè Paulo Simao Henriques; Shmuel Banai; Pierfrancesco Agostoni Journal: Am J Cardiol Date: 2020-04-07 Impact factor: 2.778
Authors: Stefan Verheye; E Marc Jolicœur; Miles W Behan; Thomas Pettersson; Paul Sainsbury; Jonathan Hill; Mathias Vrolix; Pierfrancesco Agostoni; Thomas Engstrom; Marino Labinaz; Ranil de Silva; Marc Schwartz; Nathalie Meyten; Neal G Uren; Serge Doucet; Jean-François Tanguay; Steven Lindsay; Timothy D Henry; Christopher J White; Elazer R Edelman; Shmuel Banai Journal: N Engl J Med Date: 2015-02-05 Impact factor: 91.245
Authors: Timothy D Henry; Daniel Satran; James S Hodges; Randall K Johnson; Anil K Poulose; Alex R Campbell; Ross F Garberich; Bradley A Bart; Rachel E Olson; Charlene R Boisjolie; Karen L Harvey; Theresa L Arndt; Jay H Traverse Journal: Eur Heart J Date: 2013-05-12 Impact factor: 29.983