{"title":"希望能更好地选择心脏收缩力调节的患者。","authors":"Daniele Masarone, Ishu Rao, Giuseppe Pacileo","doi":"10.1080/17434440.2023.2217329","DOIUrl":null,"url":null,"abstract":"Cardiac contractility modulation (CCM) is an innovative devicebased therapy for the treatment of patients with heart failure (HF) with mildly reduced ejection fraction (HFmrEF) and reduced ejection fraction (HFrEF) with a narrow QRS complex (and therefore with no indication for cardiac resynchronization therapy). The CCM therapy is based on the delivery, by an impulse pocket generator (Optimizer Smart®), of high-voltage (≈7.5 V) and long-duration (≈20 ms) biphasic electrical signals to the septal wall of the right ventricle during the absolute refractory period of the myocardium [1]. Therefore, these signals do not cause a novel myocardial contraction, but induce an improvement in calcium handling and, consequently, an increase in myocardial contractility [2]. Besides improving calcium handling, CCM therapy induces several positive effects (Table 1) that affects the entire biology of the failing myocardium [3–5]. In randomized controlled trials, CCM therapy improves functional capacity (i.e. VO2 peak at cardiopulmonary exercise test) [6]; also, in a real-world registry, CCM therapy is associated with a lower rate of HF-related hospitalizations [7]. In addition, CCM therapy induces both left and right ventricular reverse remodeling [8–10]. Based on the results of these randomized clinical trials, the Optimizer Smart® system has been approved in countries covered by CE markings since October 2016 and granted United States Food and Drug Administration (FDA) approval in March 2019. As with all device-based therapies for HF, appropriate patient selection is crucial for increasing the possibility of clinical and echocardiographic response. Because no practical guidance on proper patient selection for CCM therapy is currently provided by the European Society of Cardiology and the American College of Cardiology/American Heart Association guidelines [11,12], we proposed the HOPE algorithm as a simple tool for screening and selecting outpatients with HFrEF/HFmrEF in which CCM therapy is more likely to be effective (Figure 1).","PeriodicalId":12330,"journal":{"name":"Expert Review of Medical Devices","volume":null,"pages":null},"PeriodicalIF":2.9000,"publicationDate":"2023-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"1","resultStr":"{\"title\":\"HOPE for a better selection of patients for cardiac contractility modulation.\",\"authors\":\"Daniele Masarone, Ishu Rao, Giuseppe Pacileo\",\"doi\":\"10.1080/17434440.2023.2217329\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"Cardiac contractility modulation (CCM) is an innovative devicebased therapy for the treatment of patients with heart failure (HF) with mildly reduced ejection fraction (HFmrEF) and reduced ejection fraction (HFrEF) with a narrow QRS complex (and therefore with no indication for cardiac resynchronization therapy). The CCM therapy is based on the delivery, by an impulse pocket generator (Optimizer Smart®), of high-voltage (≈7.5 V) and long-duration (≈20 ms) biphasic electrical signals to the septal wall of the right ventricle during the absolute refractory period of the myocardium [1]. Therefore, these signals do not cause a novel myocardial contraction, but induce an improvement in calcium handling and, consequently, an increase in myocardial contractility [2]. Besides improving calcium handling, CCM therapy induces several positive effects (Table 1) that affects the entire biology of the failing myocardium [3–5]. In randomized controlled trials, CCM therapy improves functional capacity (i.e. VO2 peak at cardiopulmonary exercise test) [6]; also, in a real-world registry, CCM therapy is associated with a lower rate of HF-related hospitalizations [7]. In addition, CCM therapy induces both left and right ventricular reverse remodeling [8–10]. Based on the results of these randomized clinical trials, the Optimizer Smart® system has been approved in countries covered by CE markings since October 2016 and granted United States Food and Drug Administration (FDA) approval in March 2019. As with all device-based therapies for HF, appropriate patient selection is crucial for increasing the possibility of clinical and echocardiographic response. Because no practical guidance on proper patient selection for CCM therapy is currently provided by the European Society of Cardiology and the American College of Cardiology/American Heart Association guidelines [11,12], we proposed the HOPE algorithm as a simple tool for screening and selecting outpatients with HFrEF/HFmrEF in which CCM therapy is more likely to be effective (Figure 1).\",\"PeriodicalId\":12330,\"journal\":{\"name\":\"Expert Review of Medical Devices\",\"volume\":null,\"pages\":null},\"PeriodicalIF\":2.9000,\"publicationDate\":\"2023-07-01\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"1\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Expert Review of Medical Devices\",\"FirstCategoryId\":\"5\",\"ListUrlMain\":\"https://doi.org/10.1080/17434440.2023.2217329\",\"RegionNum\":3,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q3\",\"JCRName\":\"ENGINEERING, BIOMEDICAL\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Expert Review of Medical Devices","FirstCategoryId":"5","ListUrlMain":"https://doi.org/10.1080/17434440.2023.2217329","RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q3","JCRName":"ENGINEERING, BIOMEDICAL","Score":null,"Total":0}
HOPE for a better selection of patients for cardiac contractility modulation.
Cardiac contractility modulation (CCM) is an innovative devicebased therapy for the treatment of patients with heart failure (HF) with mildly reduced ejection fraction (HFmrEF) and reduced ejection fraction (HFrEF) with a narrow QRS complex (and therefore with no indication for cardiac resynchronization therapy). The CCM therapy is based on the delivery, by an impulse pocket generator (Optimizer Smart®), of high-voltage (≈7.5 V) and long-duration (≈20 ms) biphasic electrical signals to the septal wall of the right ventricle during the absolute refractory period of the myocardium [1]. Therefore, these signals do not cause a novel myocardial contraction, but induce an improvement in calcium handling and, consequently, an increase in myocardial contractility [2]. Besides improving calcium handling, CCM therapy induces several positive effects (Table 1) that affects the entire biology of the failing myocardium [3–5]. In randomized controlled trials, CCM therapy improves functional capacity (i.e. VO2 peak at cardiopulmonary exercise test) [6]; also, in a real-world registry, CCM therapy is associated with a lower rate of HF-related hospitalizations [7]. In addition, CCM therapy induces both left and right ventricular reverse remodeling [8–10]. Based on the results of these randomized clinical trials, the Optimizer Smart® system has been approved in countries covered by CE markings since October 2016 and granted United States Food and Drug Administration (FDA) approval in March 2019. As with all device-based therapies for HF, appropriate patient selection is crucial for increasing the possibility of clinical and echocardiographic response. Because no practical guidance on proper patient selection for CCM therapy is currently provided by the European Society of Cardiology and the American College of Cardiology/American Heart Association guidelines [11,12], we proposed the HOPE algorithm as a simple tool for screening and selecting outpatients with HFrEF/HFmrEF in which CCM therapy is more likely to be effective (Figure 1).
期刊介绍:
The journal serves the device research community by providing a comprehensive body of high-quality information from leading experts, all subject to rigorous peer review. The Expert Review format is specially structured to optimize the value of the information to reader. Comprehensive coverage by each author in a key area of research or clinical practice is augmented by the following sections:
Expert commentary - a personal view on the most effective or promising strategies
Five-year view - a clear perspective of future prospects within a realistic timescale
Key issues - an executive summary cutting to the author''s most critical points
In addition to the Review program, each issue also features Medical Device Profiles - objective assessments of specific devices in development or clinical use to help inform clinical practice. There are also Perspectives - overviews highlighting areas of current debate and controversy, together with reports from the conference scene and invited Editorials.