Usefulness of Coronary Sinus Reducer Implantation for the Treatment of Chronic Refractory Angina Pectoris

被引:23
作者
D'Amico, Gianpiero [1 ]
Giannini, Francesco [2 ]
Massussi, Mauro [1 ]
Tebaldi, Matteo [3 ]
Cafaro, Alessandro [4 ]
Ielasi, Alfonso [5 ]
Sgura, Fabio [6 ]
De Marco, Federico [7 ]
Stefanini, Giulio G. [8 ]
Ciardetti, Marco [9 ]
Versaci, Francesco [10 ]
Latini, Roberto A. [11 ]
Sacca, Salvatore [12 ]
Ghiringhelli, Sergio [13 ,14 ]
Picchi, Andrea [15 ]
Cerrito, Marco [16 ]
Gaspardone, Achille [17 ]
Tarantini, Giuseppe [1 ]
机构
[1] Univ Padua, Dept Cardiol Thorac & Vasc Sci & Publ Hlth, Padua, Italy
[2] GVM Care & Res Maria Cecilia Hosp, Intervent Cardiol Unit, Cotignola, Italy
[3] Azienda Osped Univ Ferrara, Cardiovasc Inst, Cona, FE, Italy
[4] Gen Hosp F Miulli, Dept Cardiol, Bari, Italy
[5] S tAmbrogio Cardiothorac Ctr, Clin & Intervent Cardiol Unit, Milan, Italy
[6] Univ Modena & Reggio Emilia, Policlin Hosp, Inst Cardiol, Modena, Italy
[7] IRCCS Policlin San Donato, Dept Clin & Intervent Cardiol, Milan, Italy
[8] Humanitas Clin & Res Hosp IRCCS, Cardio Ctr, Milan, Italy
[9] Fdn Toscana Gabriele Monasterio, Pisa, Italy
[10] Santa Maria Goretti Hosp, Cardiol Unit, Latina, Italy
[11] ASST Fatebenefratelli Sacco, Osped Fatebenefratelli, UOC Cardiol, Milan, Italy
[12] Mirano Gen Hosp, Cardiol Dept, Mirano, Italy
[13] Univ Insubria, Osped Circolo, Dept Cardiovasc Dis, Cardiol 1, Varese, Italy
[14] Univ Insubria, Fdn Macchi ASST Sette Laghi, Varese, Italy
[15] Misericordia Hosp, Cardiol Dept, Grosseto, Italy
[16] Papardo Hosp, Dept Cardiol, Messina, Italy
[17] Osped St Eugenio, Div Cardiol, Rome, Italy
关键词
DEVICE; EFFICACY; SAFETY; NARROW;
D O I
10.1016/j.amjcard.2020.09.045
中图分类号
R5 [内科学];
学科分类号
1002 ; 100201 ;
摘要
The coronary sinus (CS) Reducer is a novel device designed for the management of patients with severe angina symptoms refractory to optimal medical therapy and not amenable to further revascularization. Aim of this study was to investigate the efficacy and the safety of the CS Reducer device in a real-world, multicenter, and country-level cohort of patients presenting with refractory angina pectoris. The study included patients affected by refractory angina pectoris who underwent CS Reducer implantation in 16 centers. Clinical follow-up was carried as per each center's protocol. One hundred eighty-seven patients were included. Technical and procedural success were achieved in 98% and 95%, respectively. Minor peri-procedural complications were recorded in 8 patients. During a median follow-up of 18.4 months, 135 (82.8%) patients demonstrated at least 1 CCS class reduction after Reducer implantation, and 80 (49%) patients at least 2 CCS class reduction. Mean CCS class improved from 3.05 +/- 0.53 at baseline to 1.63 +/- 0.98 at follow-up (p < 0.001). Treatment benefit was also reflected in a significant improvement in quality of life scores and in a reduction of the mean number of anti-ischemic drugs prescribed for patient. In conclusion, in this multicenter, country-level study, the implantation of CS Reducer in patients with refractory angina pectoris resulted to be safe and effective in reducing of angina pectoris and improving quality of life. (C) 2020 Elsevier Inc. All rights reserved.
引用
收藏
页码:22 / 27
页数:6
相关论文
共 23 条
[1]   Safety and efficacy of a device to narrow the coronary sinus for the treatment of refractory angina: A single-centre real-world experience [J].
Abawi, M. ;
Nijhoff, F. ;
Stella, P. R. ;
Voskuil, M. ;
Benedetto, D. ;
Doevendans, P. A. ;
Agostoni, P. .
NETHERLANDS HEART JOURNAL, 2016, 24 (09) :544-551
[2]   Coronary sinus reducer non-responders: insights and perspectives [J].
Baldetti, Luca ;
Colombo, Antonio ;
Banai, Shmuel ;
Latib, Azeem ;
Esposito, Antonio ;
Palmisano, Anna ;
Giannini, Francesco .
EUROINTERVENTION, 2018, 13 (14) :1667-1669
[3]   Coronary sinus reducer stent for the treatment of chronic refractory angina pectoris - A prospective, open-label, multicenter, safety feasibility first-in-man study [J].
Banai, Shmuel ;
Ben Muvhar, Shmuel ;
Parikh, Keyur H. ;
Medina, Aharon ;
Sievert, Horst ;
Seth, Ashok ;
Tsehori, Jonathan ;
Paz, Yoav ;
Sheinfeld, Arni ;
Keren, Gad .
JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY, 2007, 49 (17) :1783-1789
[4]   Coronary sinus perforation during reducer implantation [J].
Cortese, Bernardo ;
di Palma, Gaetano ;
Latini, Roberto .
CATHETERIZATION AND CARDIOVASCULAR INTERVENTIONS, 2018, 91 (07) :1291-1293
[5]   Coronary sinus reducer implantation in the middle cardiac vein for the treatment of refractory angina [J].
D'Amico, Gianpiero ;
Massussi, Mauro ;
Fraccaro, Chiara ;
Tarantini, Giuseppe .
CATHETERIZATION AND CARDIOVASCULAR INTERVENTIONS, 2020, 95 (04) :718-721
[6]   Refractory Angina From Pathophysiology to New Therapeutic Nonpharmacological Technologies [J].
Gallone, Guglielmo ;
Baldetti, Luca ;
Tzanis, Georgios ;
Gramegna, Mario ;
Latib, Azeem ;
Colombo, Antonio ;
Henry, Timothy D. ;
Giannini, Francesco .
JACC-CARDIOVASCULAR INTERVENTIONS, 2020, 13 (01) :1-19
[7]   Cost-effectiveness of the coronary sinus Reducer and its impact on the healthcare burden of refractory angina patients [J].
Gallone, Guglielmo ;
Armeni, Patrizio ;
Verheye, Stefan ;
Agostoni, Pierfrancesco ;
Timmers, Leo ;
Campo, Gianluca ;
Ielasi, Alfonso ;
Sgura, Fabio ;
Tarantini, Giuseppe ;
Rosseel, Liesbeth ;
Zivelonghi, Carlo ;
Leenders, Geert ;
Stella, Pieter ;
Tebaldi, Matteo ;
Tespili, Maurizio ;
D'Amico, Gianpiero ;
Baldetti, Luca ;
Ponticelli, Francesco ;
Colombo, Antonio ;
Giannini, Francesco .
EUROPEAN HEART JOURNAL-QUALITY OF CARE AND CLINICAL OUTCOMES, 2020, 6 (01) :32-40
[8]   Technical aspects in coronary sinus Reducer implantation [J].
Giannini, Francesco ;
Tzanis, Georgios ;
Ponticelli, Francesco ;
Baldetti, Luca ;
Demir, Ozan M. ;
Mitomo, Satoru ;
Gallone, Guglielmo ;
Banai, Shmuel ;
Colombo, Antonio .
EUROINTERVENTION, 2020, 15 (14) :1269-1277
[9]   Safety and efficacy of the reducer: A multi-center clinical registry - REDUCE study [J].
Giannini, Francesco ;
Baldetti, Luca ;
Konigstein, Maayan ;
Rosseel, Liesbeth ;
Ruparelia, Neil ;
Gallone, Guglielmo ;
Colombo, Antonio ;
Banai, Shmuel ;
Verheye, Stefan .
INTERNATIONAL JOURNAL OF CARDIOLOGY, 2018, 269 :40-44
[10]   Coronary Sinus Reducer Implantation for the Treatment of Chronic Refractory Angina A Single-Center Experience [J].
Giannini, Francesco ;
Baldetti, Luca ;
Ponticelli, Francesco ;
Ruparelia, Neil ;
Mitomo, Satoru ;
Latib, Azeem ;
Montorfano, Matteo ;
Jabbour, Richard J. ;
Aurelio, Andrea ;
Ferri, Luca ;
Mangieri, Antonio ;
Regazzoli, Damiano ;
Ancona, Marco ;
Pagnesi, Matteo ;
Faccini, Alessia ;
Chieffo, Alaide ;
Azzalini, Lorenzo ;
Carlino, Mauro ;
Colombo, Antonio .
JACC-CARDIOVASCULAR INTERVENTIONS, 2018, 11 (08) :784-792