无电极起搏的未来与方向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有电极起搏的麻烦有电极起搏的麻烦起搏器和电极的急性并发症起搏器和电极的急性并发症血肿血肿 (5%, 使用肝素使用肝素+)电极脱位电极脱位 (0.5% )慢性电极问题慢性电极问题挤压（挤压（Crush）, 电极断裂电极断裂, 磨损等磨损等. (包括囊袋、锁骨下包括囊袋、锁骨下静脉和心脏静脉和心脏)系统连接问题系统连接问题 (电池耗竭电池耗竭+)起搏器囊袋并发症起搏器囊袋并发症皮肤溃烂皮肤溃烂: 首次置入为首次置入为0.4% t, 更换为更换为4.5%切口和囊袋疼痛切口和囊袋疼痛有电极起搏的麻烦有电极起搏的麻烦感染感染术后一年内达术后一年内达 1.2% 心内膜炎占全部病人的心内膜炎占全部病人的 5% 电极拔除死亡风险达电极拔除死亡风险达 1% ，严重并发症达，严重并发症达 2% 电极对血管和心脏结构的影响电极对血管和心脏结构的影响三尖瓣受损三尖瓣受损 （20% 患者有三尖瓣反流）患者有三尖瓣反流）静脉狭窄静脉狭窄/血栓形成血栓形成 (达达25%)上腔静脉综合症上腔静脉综合症 (1%)美容问题美容问题置入技术和随访需要的专业人员置入技术和随访需要的专业人员有电极起搏的麻烦有电极起搏的麻烦起搏电极失效起搏电极失效置入后置入后10年达到年达到 21%除颤电极失效除颤电极失效ICD ICD 置入置入8 8年内年内38%38%电极需要更换电极需要更换无电极起搏的设想和尝试无电极起搏的设想和尝试至今共有至今共有6-8种原创设想，但是都仅限于临床前种原创设想，但是都仅限于临床前研究，包括研究，包括高频信号多点起搏高频信号多点起搏腔内电极用作天线接收起搏信号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心腔内置入高能电池无电极起搏器微型微型VVIR无电极起搏器无电极起搏器无电极起搏器的递送系统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器置入后情况无电极起搏的技术挑战无电极起搏的技术挑战Not for the Faint of Heart!固定技术固定技术 既有超强的抓力，又要可以重撤出和重置输送系统输送系统不能太粗，便于操作全新的能原系统全新的能原系统目前可望使用10年高密度整合的电子系高密度整合的电子系统统生物可相容性生物可相容性终生密封系统终生密封系统 （Lifetime hermeticity）电极电极-组织界面组织界面; 低而低而稳定的起搏阈值稳定的起搏阈值超低能耗电路超低能耗电路表面涂层表面涂层不形成血栓心内频率响应心内频率响应交流系统交流系统外部 (telemetry; wireless)体内置入装置之间Integration of all of the above!Integration of all of the above!临床潜在风险临床潜在风险固定固定/脱位脱位大腔导管大腔导管 (20-26Fr)置入过程置入过程血流动力学血流动力学血管并发症血管并发症长期低而稳定的阈值长期低而稳定的阈值血栓栓塞危险血栓栓塞危险是否能取出是否能取出?Miniaturized, Leadless VVIR Pacer+Steerable Sheath/Catheter无电极起搏的方向和未来无电极起搏的方向和未来减轻创伤减轻创伤 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 提高治疗的价提高治疗的价- -效比效比 缩短住院期 减少急性和慢性并发症 可能取出谢谢谢谢未来看好！Innovation S-curve in Implantable Bradycardia TherapyTechnological performance often follows an S-shaped curvePerformanceEffort (funds) and/or TimePhysical limit of technologyFirst implantable, transvenous pacemaker Chardack-Greatbatch,1960Rate response Activitrax,1986Full automaticity EnPulseMVP + full automaticity AdaptaMR Conditional Revo/Advisa MRI SureScanDual-demand pulse generator ByrelFirst microprocessor-based, mode switching TheraPhysiologic dual-sensor (activity/MV) Kappa1.Unmet Needs in Cardiac PacingAcute complications 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% after replacementPain at incision/pocket1.Unmet Needs in Cardiac PacingInfectionUp 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:Tricuspid valve impairment (20% of implanted pts with TV regurgitation)Venous stenosis/thrombosis (up to 25%)SVC syndrome (1%)CosmesisAvailability of specialists for implant/follow-upEmerging Markets1.Unmet Needs in Cardiac PacingPacing lead failureUp to 21% within 10 years after pacemaker implantationDefibrillator lead failureLead replacement is mandatory in 38% within 8 years after ICD implantationTechnical Challenges in Leadless Pacing:Not for the Faint of Heart!Fixation technology Superior holding force, but enable repositioning/retrievalDelivery systemsNovel power sourcesIncreased electronic packaging densityBiocompatible device packagingLifetime hermeticityElectrode-tissue interface; low, stable pacing thresholdsUltra-low power circuitrySurface coatingsRate response-intracardiacCommunication systems:External (telemetry; wireless)Inter-device (intrabody)Integration of all of the above!Integration of all of the above!Potential Clinical RisksFixation/dislodgementLarge-bore catheters (20-26Fr)Access challengesHemostasisVascular complicationsLow, stable chronic thresholdsThromboembolic riskExtraction?Miniaturized, Leadless VVIR Pacer+Steerable Sheath/CatheterLeadless Pacemaker Potential BenefitsLeadless Pacemaker Potential BenefitsReduced InvasivenessReduced InvasivenessNo surgeryFewer complications (no lead or subQ device)Less radiation exposure for implanter (femoral)More cosmetic for patient (“invisible”) Improved Efficiency Improved Efficiency Simpler procedure; no surgeryFemoral venous accessNo system connectionsMRI conditionalMore Cost-Effective TherapyMore Cost-Effective TherapyReduced length of hospital stayFewer acute and chronic complications