《无电极起搏的未来与方向.ppt》由会员分享，可在线阅读，更多相关《无电极起搏的未来与方向.ppt（22页珍藏版）》请在三一办公上搜索。
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25%)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
2、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（Lifeti
3、me 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
4、(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 of technology,First implantable,transvenous pacemaker Chardack-Greatba
5、tch,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,Physiologic dual-sensor(activity/MV)Kappa,Unmet Needs in Cardiac Pacing,Acute compli
6、cations related to can and leadsPocket 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(battery change+)Device pocket complications:Erosion through the skin:0.4%after 1st implant,4.5%
7、after replacementPain at incision/pocket,Unmet Needs in Cardiac Pacing,InfectionUp to 1.2%within a year after procedureUp to 5%of the entire population with endocarditis1%risk of death and 2%risk of major complications at lead extractionLead interactions with vasculature and heart structures:Tricusp
8、id valve impairment(20%of implanted pts with TV regurgitation)Venous stenosis/thrombosis(up to 25%)SVC syndrome(1%)CosmesisAvailability of specialists for implant/follow-up,Unmet Needs in Cardiac Pacing,Pacing lead failureUp to 21%within 10 years after pacemaker implantationDefibrillator lead failur
9、eLead 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 holding force,but enable repositioning/retrievalDelivery systemsNovel power sourcesIncreased electronic packaging densityBiocomp
10、atible device packagingLifetime hermeticity,Electrode-tissue interface;low,stable pacing thresholdsUltra-low power circuitrySurface coatingsRate response-intracardiacCommunication systems:External(telemetry;wireless)Inter-device(intrabody),Potential Clinical Risks,Fixation/dislodgementLarge-bore cat
11、heters(20-26Fr)Access challengesHemostasisVascular complicationsLow,stable chronic thresholdsThromboembolic riskExtraction?,Miniaturized,Leadless VVIR Pacer,+,Steerable Sheath/Catheter,Leadless Pacemaker Potential Benefits,Reduced InvasivenessNo surgeryFewer complications(no lead or subQ device)Less radiation exposure for implanter(femoral)More cosmetic for patient(“invisible”)Improved Efficiency Simpler procedure;no surgeryFemoral venous accessNo system connectionsMRI conditionalMore Cost-Effective TherapyReduced length of hospital stayFewer acute and chronic complications,
