一个模块化沟通型无节奏阻器系统
Reinoud E Knops1, Michael S Lloyd1, Paul R Roberts1
1From the Department of Cardiology, Amsterdam University Medical Center, Amsterdam (R.E.K., L.V.A.B.), and the Department of Cardiology, St Antonius Ziekenhuis, Nieuwegein (L.V.A.B.) - both in the Netherlands; Emory University Section of Cardiac Electrophysiology, Atlanta (M.S.L., F.M.M.); University Hospital Southampton, Southampton (P.R.R.), the Department of Cardiology, Liverpool Heart and Chest Hospital, Liverpool (D.J.W.), and Leeds Teaching Hospitals NHS Trust, Leeds (C.P.), and Manchester Heart Centre, Manchester Royal Infirmary, Manchester (C.C.) - all in the United Kingdom; HonorHealth Cardiac Arrhythmia Group, HonorHealth Research Institute, Scottsdale, and the College of Medicine (R.D.) and Banner University Medical Center Phoenix (W.W.S.), University of Arizona, Phoenix - all in Arizona; the Department of Cardiovascular Medicine, Mayo Clinic, Rochester (P.A.F., Y.-M.C.), and Boston Scientific, St. Paul (J. West, E.M., B.S., A.J.B., J. Weinstock, K.M.S.) - both in Minnesota; the Department of Cardiology, Na Homolce Hospital, Prague, Czech Republic (P.N.); Department of Cardiology, School of Medical Sciences, Faculty of Medicine and Health, Örebro University, Örebro, Sweden (C.B.-L.); Heart Rhythm Clinic, San Rossore Hospital, Pisa, Italy (M.G.B.); CorVita Science Foundation, Chicago (M.C.B.); Departement de Cardiologie, Hôpital Privé du Confluent, Nantes (D.G.), and the Arrhythmia Unit, Cardiology Department, Heart and Lung Institute, Lille (C.M.) - both in France; Cardiac Electrophysiology, Drexel University (S.P.K.), and the Cardiovascular Division, Perelman School of Medicine at the University of Pennsylvania (D.S.F.), Philadelphia, and the Department of Cardiology, Saint Mary Medical Center, Langhorne (S.P.K.) - all in Pennsylvania; OhioHealth Heart and Vascular Physicians, Section of Cardiac Electrophysiology, Department of Cardiology, OhioHealth Riverside Methodist Hospital (A.K.A., E.Y.F.), and the Section of Cardiac Electrophysiology, Division of Cardiovascular Disease, Department of Internal Medicine, Ohio State University Wexner Medical Center (R.A.) Columbus, and the Cardiac Electrophysiology and Pacing Section, Department of Cardiovascular Medicine, Cleveland Clinic, Cleveland (T.D.C.); Northwell, Hyde Park (L.M.E.), the Cardiovascular Institute, Northwell Health Manhasset, Manhasset (L.M.E.), and Icahn School of Medicine, Mount Sinai, New York (M.A.M., V.Y.R.) - all in New York; Institut Clínic Cardiovascular, Hospital Clínic, Universitat de Barcelona, and Institut d'Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS), Barcelona, and Centro de Investigación Biomédica en Red, Enfermedades Cardiovasculares (CIBERCV), Madrid (J.M.T., L.M.); Baptist Health Lexington, Lexington, KY (J.D.A.); Erlanger Health System, University of Tennessee, Chattanooga (H.M.); the Department of Cardiac Electrophysiology and Research, St. Bernard's Heart and Vascular Center, Arrhythmia Research Group, Jonesboro, AR (D.G.N.); Institut de Cardiologie de Montréal, Montreal Heart Institute, Université de Montréal, Montréal (B.M.); Sentara Norfolk General Hospital, Norfolk, VA (J.G.); and the Department of Cardiology, Kepler University Hospital, Medical Faculty of the Johannes Kepler University Linz, Austria (K.S.).
一种新的模块化节拍-除器系统,将无心脏起器与皮下植入式心脏转换器-除器 (ICD) 结合起来,在患有突然心脏死亡风险的患者中证明了安全性和有效性.
科学领域:
- 心脏病学 心脏病学
- 生物医学工程 生物医学工程
- 医疗器械 医疗器械
背景情况:
- 皮下植入式心脏转换器-除器 (ICDs) 减少了并发症,但缺乏胆心跳和抗胆心跳节奏.
- 模块化节拍除器系统的安全性,将无节拍器与皮下ICD集成为全面的节拍,以前是未知的.
研究的目的:
- 评估一款新型模块化节拍除器系统的安全性和性能.
- 为了评估无心脏起器相关的并发症,无线通信的成功,并在接受该系统的患者节奏值.
主要方法:
- 一项跨国单组研究招募了患有突然心脏病死亡风险的患者.
- 该系统包括一个无心脏起器,与皮下ICD无线通信.
- 随访时间为6个月,对预先规定的目标进行安全性和性能终点的评估.
主要成果:
- 97.5%的患者没有主要的无心脏起器并发症,超过了86%的目标.
- 设备之间的无线通信在98.8%的测试中取得了成功 (目标:88%).
- 97.4%的患者在0.4毫秒内达到≤2.0V的节奏值 (目标:80%),61.3%的心律失常成功通过抗心动节奏结束.
结论:
- 模块化节拍除器系统在6个月内达到或超过了安全性和有效性的所有性能目标.
- 这种系统为皮下ICD患者的胸和抗心动节奏节奏提供了一个有前途的解决方案.
- 这项研究证实了无心脏起器和皮下ICD之间无线通信的可行性,以加强心律管理.
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