Francesco Giannini1, Luca Baldetti2, Maayan Konigstein3, Liesbeth Rosseel4, Neil Ruparelia2, Guglielmo Gallone2, Antonio Colombo2, Shmuel Banai3, Stefan Verheye4. 1. Unit of Cardiovascular Interventions, IRCCS San Raffaele Scientific Institute, Milan, Italy. Electronic address: giannini_fra@yahoo.it. 2. Unit of Cardiovascular Interventions, IRCCS San Raffaele Scientific Institute, Milan, Italy. 3. Department of Cardiology, Tel-Aviv Medical Center, Sackler Faculty of Medicine, Tel-Aviv University, Tel-Aviv, Israel. 4. Cardiovascular Center, Ziekenhuis Netwerk Antwerpen Middelheim, Antwerp, Belgium.
Abstract
BACKGROUND: The coronary sinus (CS) Reducer is a novel device designed to aid in the management and to improve quality of life of patients with severe angina symptoms refractory to optimal medical and interventional therapies. This study aims to assess the safety and efficacy of the Reducer in a real-world cohort of patients presenting with refractory angina. METHODS: One hundred forty-one consecutive patients were treated with CS Reducer implantation. The primary efficacy endpoint was reduction in angina symptoms from baseline as assessed by Canadian Cardiovascular Society (CCS) class status and Seattle Angina Questionnaire (SAQ) scores. The primary safety endpoint was successful Reducer device delivery and deployment in the absence of any device-related events. RESULTS: Procedural success was achieved in 139 (98.6%) patients. Reducer implantation was not obtained in 2 (1.4%) patients because of unfavorable anatomy of the CS. There were no CS perforations, cardiac tamponade, peri-procedural death or myocardial infarction during a median follow-up of 14 months (range from 6- to 70-month). In patients undergoing Reducer implantation, mean CCS class improved from 3.05 ± 0.53 at baseline to 1.63 ± 0.98 at follow-up (p < 0.001). Overall, 113 (81%) patients experienced at least 1 CCS improvement, and 63 (45%) patients at least 2 CCS-class improvement. All SAQ items improved significantly (p < 0.001 for all) and translated into a significant reduction in the mean number of anti-ischemic drugs prescribed (2.37 ± 0.97 vs 2.17 ± 0.95; p = 0.003). CONCLUSIONS: In a real-world multi-center experience, implantation of the CS Reducer appears safe, and efficacious in reducing symptoms of angina and improving quality of life.
BACKGROUND: The coronary sinus (CS) Reducer is a novel device designed to aid in the management and to improve quality of life of patients with severe angina symptoms refractory to optimal medical and interventional therapies. This study aims to assess the safety and efficacy of the Reducer in a real-world cohort of patients presenting with refractory angina. METHODS: One hundred forty-one consecutive patients were treated with CS Reducer implantation. The primary efficacy endpoint was reduction in angina symptoms from baseline as assessed by Canadian Cardiovascular Society (CCS) class status and Seattle Angina Questionnaire (SAQ) scores. The primary safety endpoint was successful Reducer device delivery and deployment in the absence of any device-related events. RESULTS: Procedural success was achieved in 139 (98.6%) patients. Reducer implantation was not obtained in 2 (1.4%) patients because of unfavorable anatomy of the CS. There were no CS perforations, cardiac tamponade, peri-procedural death or myocardial infarction during a median follow-up of 14 months (range from 6- to 70-month). In patients undergoing Reducer implantation, mean CCS class improved from 3.05 ± 0.53 at baseline to 1.63 ± 0.98 at follow-up (p < 0.001). Overall, 113 (81%) patients experienced at least 1 CCS improvement, and 63 (45%) patients at least 2 CCS-class improvement. All SAQ items improved significantly (p < 0.001 for all) and translated into a significant reduction in the mean number of anti-ischemic drugs prescribed (2.37 ± 0.97 vs 2.17 ± 0.95; p = 0.003). CONCLUSIONS: In a real-world multi-center experience, implantation of the CS Reducer appears safe, and efficacious in reducing symptoms of angina and improving quality of life.
Authors: Francesco Giannini; Anna Palmisano; Luca Baldetti; Giulia Benedetti; Francesco Ponticelli; Paola M V Rancoita; Neil Ruparelia; Guglielmo Gallone; Marco Ancona; Antonio Mangieri; Georgios Tzanis; Francesco De Cobelli; Alessandro Del Maschio; Antonio Colombo; Antonio Esposito Journal: Circ Cardiovasc Imaging Date: 2019-08-27 Impact factor: 7.792
Authors: M J M Silvis; M Dekker; C Zivelonghi; P Agostoni; P R Stella; P A Doevendans; D P V de Kleijn; J P van Kuijk; G E Leenders; L Timmers Journal: Neth Heart J Date: 2020-12-07 Impact factor: 2.380
Authors: Maayan Konigstein; Francesco Ponticelli; Carlo Zivelonghi; Ilan Merdler; Miri Revivo; Stefan Verheye; Francesco Giannini; Shmuel Banai Journal: Clin Cardiol Date: 2021-02-19 Impact factor: 3.287