無電極起搏的未來與方向

1、1心內(nèi)科 方全2013-7-262起搏器和電極的急性并發(fā)癥起搏器和電極的急性并發(fā)癥血腫血腫 (5%, 使用肝素使用肝素+)電極脫位電極脫位 (0.5% )慢性電極問題慢性電極問題擠壓（擠壓（Crush）, 電極斷裂電極斷裂, 磨損等磨損等. (包括囊袋、鎖骨下包括囊袋、鎖骨下靜脈和心臟靜脈和心臟)系統(tǒng)連接問題系統(tǒng)連接問題 (電池耗竭電池耗竭+)起搏器囊袋并發(fā)癥起搏器囊袋并發(fā)癥皮膚潰爛皮膚潰爛: 首次置入為首次置入為0.4% t, 更換為更換為4.5%切口和囊袋疼痛切口和囊袋疼痛3感染感染術(shù)后一年內(nèi)達(dá)術(shù)后一年內(nèi)達(dá) 1.2% 心內(nèi)膜炎占全部病人的心內(nèi)膜炎占全部病人的 5% 電極拔除死亡風(fēng)險(xiǎn)達(dá)電極拔

2、除死亡風(fēng)險(xiǎn)達(dá) 1% ，嚴(yán)重并發(fā)癥達(dá)，嚴(yán)重并發(fā)癥達(dá) 2% 電極對血管和心臟結(jié)構(gòu)的影響電極對血管和心臟結(jié)構(gòu)的影響三尖瓣受損三尖瓣受損 （20% 患者有三尖瓣反流）患者有三尖瓣反流）靜脈狹窄靜脈狹窄/血栓形成血栓形成 (達(dá)達(dá)25%)上腔靜脈綜合癥上腔靜脈綜合癥 (1%)美容問題美容問題置入技術(shù)和隨訪需要的專業(yè)人員置入技術(shù)和隨訪需要的專業(yè)人員4起搏電極失效起搏電極失效置入后置入后10年達(dá)到年達(dá)到 21%除顫電極失效除顫電極失效ICD ICD 置入置入8 8年內(nèi)年內(nèi)38%38%電極需要更換電極需要更換5至今共有至今共有6-86-8種原創(chuàng)設(shè)想，但是都僅限于臨床種原創(chuàng)設(shè)想，但是都僅限于臨床前研究，包括前研究

3、，包括高頻信號多點(diǎn)起搏高頻信號多點(diǎn)起搏腔內(nèi)電極用作天線接收起搏信號腔內(nèi)電極用作天線接收起搏信號心外高能起搏（超聲和射頻）心外高能起搏（超聲和射頻）心腔內(nèi)置入高能電池?zé)o電極起搏器心腔內(nèi)置入高能電池?zé)o電極起搏器678910固定技術(shù)固定技術(shù) 既有超強(qiáng)的抓力，又要可以重撤出和重置輸送系統(tǒng)輸送系統(tǒng)不能太粗，便于操作全新的能原系統(tǒng)全新的能原系統(tǒng)目前可望使用10年高密度整合的電子系高密度整合的電子系統(tǒng)統(tǒng)生物可相容性生物可相容性終生密封系統(tǒng)終生密封系統(tǒng) （Lifetime hermeticity）電極電極-組織界面組織界面; 低而低而穩(wěn)定的起搏閾值穩(wěn)定的起搏閾值超低能耗電路超低能耗電路表面涂層表面涂層不形成血

4、栓心內(nèi)頻率響應(yīng)心內(nèi)頻率響應(yīng)交流系統(tǒng)交流系統(tǒng)外部 (telemetry; wireless)體內(nèi)置入裝置之間11固定固定/ /脫位脫位大腔導(dǎo)管大腔導(dǎo)管 (20-26Fr) (20-26Fr)置入過程置入過程血流動(dòng)力學(xué)血流動(dòng)力學(xué)血管并發(fā)癥血管并發(fā)癥長期低而穩(wěn)定的閾值長期低而穩(wěn)定的閾值血栓栓塞危險(xiǎn)血栓栓塞危險(xiǎn)是否能取出是否能取出? ?12Miniaturized, Leadless VVIR Pacer+Steerable Sheath/Catheter 不用手術(shù) 減少并發(fā)癥 (no lead or subQ device) 減少放射 不影響美觀 (“invisible”) 操作簡單 股靜脈入路(f

5、emoral) 沒有系統(tǒng)連接 有可能接受MRI 縮短住院期 減少急性和慢性并發(fā)癥 可能取出13謝謝謝謝未來看好！141516Innovation 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,19

6、60Rate 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) Kappa17Unmet Needs in Cardiac PacingAcute complications

7、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 impl

8、ant, 4.5% after replacementPain at incision/pocket18Unmet 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 stru

9、ctures: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 Markets19Unmet Needs in Cardiac PacingPacing lead failureUp to 21% within 10 years after pacemaker im

10、plantationDefibrillator lead failureLead replacement is mandatory in 38% within 8 years after ICD implantation20Technical Challenges in Leadless Pacing:Not for the Faint of Heart!Fixation technology Superior holding force, but enable repositioning/retrievalDelivery systemsNovel power sourcesIncrease

11、d 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)21Potential Clinical

12、 RisksFixation/dislodgementLarge-bore catheters (20-26Fr)Access challengesHemostasisVascular complicationsLow, stable chronic thresholdsThromboembolic riskExtraction?22Miniaturized, Leadless VVIR Pacer+Steerable Sheath/CatheterNo surgeryFewer complications (no lead or subQ device)Less radiation exposure for implanter (femoral)Mor