Author + information
- Received September 15, 2017
- Revision received November 20, 2017
- Accepted January 9, 2018
- Published online April 16, 2018.
- Francesco Giannini, MD∗ (, )
- Luca Baldetti, MD,
- Francesco Ponticelli, MD,
- Neil Ruparelia, MD,
- Satoru Mitomo, MD,
- Azeem Latib, MD,
- Matteo Montorfano, MD,
- Richard J. Jabbour, MD,
- Andrea Aurelio, MD,
- Luca Ferri, MD,
- Antonio Mangieri, MD,
- Damiano Regazzoli, MD,
- Marco Ancona, MD,
- Matteo Pagnesi, MD,
- Alessia Faccini, MD,
- Alaide Chieffo, MD,
- Lorenzo Azzalini, MD,
- Mauro Carlino, MD and
- Antonio Colombo, MD
- ↵∗Address for correspondence:
Dr. Francesco Giannini, Interventional Cardiology Unit, San Raffaele Scientific Institute, Via Olgettina 60, 20132 Milan, Italy.
Objectives The aim of this study was to assess the safety and efficacy of the Reducer in a real-world cohort of patients presenting with refractory angina.
Background The coronary sinus Reducer is a novel device to aid in the management of patients with severe angina symptoms refractory to optimal medical therapy and not amenable to further revascularization.
Methods Fifty patients with refractory angina and objective evidence of myocardial ischemia who were judged unsuitable for revascularization were treated with coronary sinus Reducer implantation at a single center between March 2015 and August 2016. Safety endpoints were procedural success and the absence of device-related adverse events. Efficacy endpoints, assessed at 4- and 12-month follow-up, were a reduction in Canadian Cardiovascular Society angina class, improvement in quality of life assessed using the Seattle Angina Questionnaire, improvement in exercise tolerance assessed using the 6-min walk test, and reduction in pharmacological antianginal therapy.
Results Procedural success was achieved in all patients, with no device-related adverse effects during the procedure or at follow-up. Regarding the efficacy endpoint, 40 patients (80%) had at least 1 reduction in Canadian Cardiovascular Society class, and 20 patients (40%) had at least 2 class reductions, with a mean class reduction to 1.67 ± 0.83 vs. 2.98 ± 0.52 (p < 0.001) at 4-month follow-up. All Seattle Angina Questionnaire items improved significantly (p < 0.001 for all). A significant increment in 6-min walk distance to 388.6 ± 119.7 m vs. 287.0 ± 138.9 m (p = 0.004) was observed. Sixteen patients (32%) and 3 patients (6%) demonstrated reductions of at least 1 or 2 antianginal drugs, respectively. The benefit of Reducer implantation observed at 4-month follow-up was maintained at 1 year.
Conclusions In this real-world, single-center experience, implantation of the coronary sinus Reducer appeared safe and was associated with reduction in anginal symptoms and improvement in quality of life in patients with refractory angina who were not candidates for further revascularization.
Dr. Giannini is a consultant for Neovasc. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
- Received September 15, 2017.
- Revision received November 20, 2017.
- Accepted January 9, 2018.
- 2018 American College of Cardiology Foundation
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