Unit of Cardiovascular Interventions, IRCCS San Raffaele Scientific Institute, Milan, Italy.
Unit of Cardiovascular Interventions, IRCCS San Raffaele Scientific Institute, Milan, Italy.
Int J Cardiol. 2018 Oct 15;269:40-44. doi: 10.1016/j.ijcard.2018.06.116. Epub 2018 Jun 30.
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.
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.
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).
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.
冠状窦（CS）减容器是一种新型装置，旨在帮助管理和提高对最佳药物和介入治疗有反应的严重心绞痛患者的生活质量。本研究旨在评估该减容器在难治性心绞痛患者的真实世界队列中的安全性和疗效。
141 例连续患者接受 CS 减容器植入治疗。主要疗效终点是通过加拿大心血管学会（CCS）分级和西雅图心绞痛问卷（SAQ）评分评估的心绞痛症状从基线的降低。主要安全性终点是成功输送和部署减容器，而无任何与器械相关的不良事件。
139 例（98.6%）患者获得了手术成功。由于 CS 的不利解剖结构，2 例（1.4%）患者无法植入减容器。在中位随访 14 个月（6-70 个月）期间，没有 CS 穿孔、心脏压塞、围手术期死亡或心肌梗死。在接受减容器植入的患者中，CCS 分级从基线时的 3.05±0.53 改善至随访时的 1.63±0.98（p<0.001）。总体而言，113 例（81%）患者至少有 1 次 CCS 改善，63 例（45%）患者至少有 2 次 CCS 分级改善。所有 SAQ 项目均显著改善（所有项目 p<0.001），并导致抗缺血药物的平均处方数量显著减少（2.37±0.97 与 2.17±0.95；p=0.003）。
在真实世界的多中心经验中，CS 减容器的植入似乎是安全且有效的，可以减轻心绞痛症状并提高生活质量。
