无电极起搏的未来与方向.ppt

1、无电极起搏的未来与方向,北京协和医院 心内科 方全 2013-7-26,有电极起搏的麻烦,起搏器和电极的急性并发症 血肿 (5%, 使用肝素+) 电极脱位 (0.5% ) 慢性电极问题 挤压（Crush）, 电极断裂, 磨损等. (包括囊袋、锁骨下静脉和心脏) 系统连接问题 (电池耗竭+) 起搏器囊袋并发症 皮肤溃烂: 首次置入为0.4% t, 更换为4.5% 切口和囊袋疼痛,有电极起搏的麻烦,感染 术后一年内达 1.2% 心内膜炎占全部病人的 5% 电极拔除死亡风险达 1% ，严重并发症达 2% 电极对血管和心脏结构的影响 三尖瓣受损 （20% 患者有三尖瓣反流） 静脉狭窄/血栓形成 (达2

2、5%) 上腔静脉综合症 (1%) 美容问题 置入技术和随访需要的专业人员,有电极起搏的麻烦,起搏电极失效 置入后10年达到 21% 除颤电极失效 ICD 置入8年内38%电极需要更换,无电极起搏的设想和尝试,至今共有6-8种原创设想，但是都仅限于临床前研究，包括 高频信号多点起搏 腔内电极用作天线接收起搏信号 心外高能起搏（超声和射频） 心腔内置入高能电池无电极起搏器,微型VVIR无电极起搏器,无电极起搏器的递送系统,无电极起搏器置入后情况,无电极起搏的技术挑战Not for the Faint of Heart,固定技术 既有超强的抓力，又要可以重撤出和重置 输送系统 不能太粗，便于操作 全

3、新的能原系统 目前可望使用10年 高密度整合的电子系统 生物可相容性 终生密封系统 （Lifetime hermeticity,电极-组织界面; 低而稳定的起搏阈值 超低能耗电路 表面涂层 不形成血栓 心内频率响应 交流系统 外部 (telemetry; wireless) 体内置入装置之间,临床潜在风险,固定/脱位 大腔导管 (20-26Fr) 置入过程 血流动力学 血管并发症 长期低而稳定的阈值 血栓栓塞危险 是否能取出,Miniaturized, Leadless VVIR Pacer,Steerable Sheath/Catheter,无电极起搏的方向和未来,减轻创伤 不用手术 减少并

4、发症 (no lead or subQ device) 减少放射 不影响美观 (“invisible”) 提高效益 操作简单 股静脉入路(femoral) 没有系统连接 有可能接受MRI 提高治疗的价-效比 缩短住院期 减少急性和慢性并发症 可能取出,谢谢,未来看好,Innovation S-curve in Implantable Bradycardia Therapy,Technological performance often follows an S-shaped curve,Performance,Effort (funds) and/or Time,Physical limit

5、of technology,First implantable, transvenous pacemaker Chardack-Greatbatch,1960,Rate response Activitrax,1986,Full automaticity EnPulse,MVP + full automaticity Adapta,MR Conditional Revo/Advisa MRI SureScan,Dual-demand pulse generator Byrel,First microprocessor-based, mode switching Thera,Physiologi

6、c dual-sensor (activity/MV) Kappa,Unmet Needs in Cardiac Pacing,Acute complications related to can and leads Pocket hematoma (5%, heparin +) Lead dislodgement (0.5% per lead) Chronic lead reliability issues: Crush, fracture, abrasion, etc. (in: pocket, subclavian V., the heart) System connections (b

7、attery change +) Device pocket complications: Erosion through the skin: 0.4% after 1st implant, 4.5% after replacement Pain at incision/pocket,Unmet Needs in Cardiac Pacing,Infection Up to 1.2% within a year after procedure Up to 5% of the entire population with endocarditis 1% risk of death and 2%

8、risk of major complications at lead extraction Lead interactions with vasculature and heart structures: Tricuspid valve impairment (20% of implanted pts with TV regurgitation) Venous stenosis/thrombosis (up to 25%) SVC syndrome (1%) Cosmesis Availability of specialists for implant/follow-up,Unmet Ne

9、eds in Cardiac Pacing,Pacing lead failure Up to 21% within 10 years after pacemaker implantation Defibrillator lead failure Lead replacement is mandatory in 38% within 8 years after ICD implantation,Technical Challenges in Leadless Pacing:Not for the Faint of Heart,Fixation technology Superior holdi

10、ng force, but enable repositioning/retrieval Delivery systems Novel power sources Increased electronic packaging density Biocompatible device packaging Lifetime hermeticity,Electrode-tissue interface; low, stable pacing thresholds Ultra-low power circuitry Surface coatings Rate response-intracardiac

11、 Communication systems: External (telemetry; wireless) Inter-device (intrabody,Potential Clinical Risks,Fixation/dislodgement Large-bore catheters (20-26Fr) Access challenges Hemostasis Vascular complications Low, stable chronic thresholds Thromboembolic risk Extraction,Miniaturized, Leadless VVIR Pacer,Steerable Sheath/Catheter,Leadless Pacemaker Potential Benefits,Reduced Invasiveness No surgery Fewer complications (no lead or subQ device) Less radiation exposure for implanter (femoral) More cosmetic for patient (“invisible”) Improved Efficiency