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1、少见的介入瓣膜手术 肺动脉瓣 Samir Kapadia, MD, FACC Associate Professor of Medicine Director, Interventional Cardiology Fellowship Cleveland Clinic Disclosures: None,肺动脉瓣返流 (右室流出道功能障碍),先心病手术右室流出道功能障碍需行手术治疗比例升高 长期肺动脉瓣返流导致活动耐量下降,右心功能障碍和心律失常 (房性/室性) 早期纠正肺动脉瓣返流可以改善右心功能,介入治疗适应症,返流百分比30% 和持续多普勒监测右室流出道功能障碍峰速 3 m/s 右心室功
2、能障碍 活动能力下降 房性和/或室性心律失常,Melody 经导管瓣膜,Melody 经导管肺动脉瓣膜 重建和维持肺动脉瓣关闭完好 缓解管道狭窄的同时不造成新的返流,T. Jones, TCT 2008,全球的经验,Bonhauffer P, TCT 2008,Melody: 患者特征,Bonhauffer P, TCT 2008,血流动力学影响(n=121),Lurz et al, Circulation, 2008, Apr 15;117(15):1964-72,血流动力学影响(n=121),Lurz et al, Circulation, 2008, Apr 15;117(15):196
3、4-72,血流动力学影响(n=121),Lurz et al, Circulation, 2008, Apr 15;117(15):1964-72,学习曲线,Lurz et al, Circulation, 2008, Apr 15;117(15):1964-72,学习曲线,Lurz et al, Circulation, 2008, Apr 15;117(15):1964-72,Melody TPV US IDE Study,T. Jones, TCT 2008,US FDA IDE 研究 目前进展情况,初始队列研究,30名患者/ 3 个中心 前瞻性, 非随机化 2007 1月 开始 200
4、7 7月所有患者均纳入 2008 8月 向FDA递交申请 继续在5个中心进行进一步的研究 FDA 批准本研究纳入120名患者 所有患者随访5年 患者目前情况 共76 名患者 16 个慈善机构/急诊患者,T. Jones, TCT 2008,纳入标准,年龄 5 岁 体重30 kg 管道 16 mm 管道 功能障碍 纳入标准 NYHA II,III,IV 平均右室流出道功能障碍压差 35 mmHg, 或 中重度肺动脉返流 NYHA I 平均右室流出道功能障碍 40 mmHg, 或 重度 肺动脉返流合并右室扩张或功能障碍 *右心室扩张的定义是三尖瓣瓣环直径 2.0 *右心室功能障碍的定义是 右室面积
5、变化 40%,首选适应症 狭窄: 仅满足压力差标准 返流: 仅满足肺动脉返流标准 混合: 满足压力差和肺动脉返流标准,T. Jones, TCT 2008,患者特征,T. Jones, TCT 2008,操作资料,30 名患者, 29 名成功放置支架 操作时间 182 min (76 - 448) 造影时间 45 min (9-87) 入路 股静脉 29 颈内静脉 1 大小 最窄直径12.8 (8-19) 球囊大小28/30 球囊最小直径16.8 (14-20),T. Jones, TCT 2008,操作结果,93% 成功 1 例出现同种移植物破裂 1例出现术后经管道压差为 37 mm Hg
6、3 名患者(10%) 出现并发症 1 例出现室上性心动过速,需要行电转复 1例出现远端肺动脉穿孔 (弹簧栓塞治疗) 1例出现同种移植物破裂 (紧急管道替换),T. Jones, TCT 2008,血流动力学资料,T. Jones, TCT 2008,6个月随访,所有患者均完成随访 大部分患者心功能状况至少改善一级 平均右室流出道功能障碍较术前显著下降 随访期间,肺动脉瓣功能维持正常 CT随访结果未见肺动脉栓塞,T. Jones, TCT 2008,Edward-Sapien 瓣膜 纳入标准,体重35 kg 管道 16mm 重度 肺动脉返流 3+ 或40%返流分数 有症状( 心肺活动测试) 绝大
7、多数患者进行随访,Z. Hijazi, TCT 2008,Edward-Sapien 瓣膜 患者,年龄: 15-71 岁 诊断: 2 例为 Ross术后; 5 例为法四术后; 1例为 Rastelli术后 术前压差为 30-75mmHg 肺动脉瓣关闭不全: 重度 7 名患者既往行支架植入术;1名患者同时行支架植入 NYHA 分级: 2-3,Z. Hijazi, TCT 2008,Edward-Sapien 瓣膜 最初结果,8名患者中,7名成功经皮输送 1名患者,瓣膜位置不理想,瓣膜移位;手术取出和非体外循环下经心室瓣膜植入 急性压差下降 术前10-40 mm Hg 术后10-25 mm Hg
8、未出现肺动脉关闭不全,Z. Hijazi, TCT 2008,总结,目前,经皮肺动脉瓣置换术 效果令人鼓舞。 经皮肺动脉置换术的成功取决于患者的选择、影像学和密切随访.,Less Common Interventional Valves Pulmonary Valve Samir Kapadia, MD, FACC Associate Professor of Medicine Director, Interventional Cardiology Fellowship Cleveland Clinic Disclosures: None,Pulmonary Regurgitation (RV
9、OT dysfunction),Need for intervention in RVOT dysfunction following congenital heart disease repair is increasing Long standing pulmonary regurgitation leads to decreased exercise tolerance, RV dysfunction and arrhythmia (atrial/ventricular) Earlier correction of PR may preserve RV function,Indicati
10、ons for Intervention,Regurgitation Fraction 30% and RVOT peak velocity on continuous Doppler wave 3 m/s RV dysfunction Reduced exercise capacity Documented atrial and/or ventricular arrhythmias,Melody Trans-catheter Valve,Melody Trans-catheter Pulmonary Valve Restore and maintain pulmonary valve com
11、petency Relieve conduit stenosis without inducing regurgitation,T. Jones, TCT 2008,World Wide Experience,Bonhauffer P, TCT 2008,Melody: Patient Characteristics,Bonhauffer P, TCT 2008,Hemodynamic Effects (n=121),Lurz et al, Circulation, 2008, Apr 15;117(15):1964-72,Hemodynamic Effects (n=121),Lurz et
12、 al, Circulation, 2008, Apr 15;117(15):1964-72,Hemodynamic Effects (n=121),Lurz et al, Circulation, 2008, Apr 15;117(15):1964-72,Learning Curve,Lurz et al, Circulation, 2008, Apr 15;117(15):1964-72,Learning Curve,Lurz et al, Circulation, 2008, Apr 15;117(15):1964-72,Melody TPV US IDE Study,T. Jones,
13、 TCT 2008,US FDA IDE Study Current Status,Initial Cohort of 30 patients / 3 Centers Prospective, non-randomized January 2007 first implant September 2007 enrollment completed August 2008 submission to FDA for HDE approval Continued Access at 5 Centers 120 total patients approved by FDA for enrollmen
14、t All patients will be followed for 5 years Patients to Date 76 / 120 study patients 16 Compassionate / Emergency Use patients,T. Jones, TCT 2008,Inclusion Criteria,Age 5 years Weight 30 kg Conduit 16 mm Conduit dysfunction Study Inclusion Criteria NYHA II,III,IV Mean RVOT gradient 35 mmHg, or Moder
15、ate or Severe PR NYHA I Mean RVOT gradient 40 mmHg, or Severe PR with RV dilation* or dysfunction* *RV dilatation defined as z-score for tricuspid annular diameter 2.0 *RV dysfunction defined as RV fractional area change 40%,Primary Indication Groups Stenotic: Meets gradient criterion only Regurgita
16、nt: Meets PR criterion only Mixed: Meets both gradient & PR Criteria,T. Jones, TCT 2008,Patient Characteristics,T. Jones, TCT 2008,Procedural Data,N = 30 attempted, 29 stented Procedure time 182 minutes (76 - 448) Fluoroscopy time 45 minutes (9-87) Vascular approach Femoral vein 29 Jugular vein 1 Si
17、ze Narrowest diameter 12.8 (8-19) Balloon sizing 28/30 Balloon minimal waist 16.8 (14-20),T. Jones, TCT 2008,Procedural Results,93% procedural success 1 homograft rupture 1 had post-implant trans-conduit gradient of 37 mm Hg 3 subjects (10%) had procedural complications 1 SVT requiring DC cardiovers
18、ion 1 perforation of distal PA (treated with coil embolization) 1 homograft rupture (emergent conduit exchange),T. Jones, TCT 2008,Hemodynamic Data,T. Jones, TCT 2008,Six Month Follow Up,Follow-up completed in all patients Majority of patients showed an improvement of at least one NYHA class Mean RV
19、OT gradient significantly reduced from pre-implant to follow-up Pulmonary valve competency was maintained over the follow-up period CT follow-up shows no evidence of pulmonary emboli,T. Jones, TCT 2008,Edward-Sapien Valve Experience Inclusion Criteria,Weight35 kg Conduit 16mm Severe PR 3+ or 40% reg
20、urgitant fraction Subject is symptomatic ( CP exercise testing ) Must comply with F/U,Z. Hijazi, TCT 2008,Edward-Sapien Valve Experience Patient Population,Age: 15-71 years DX: 2 post Ross; 5 post Tet; 1 post Rastelli Pre Gradient 30-75mmHg PI: severe 7 patients had pre stenting; one had the stentin
21、g at the same time of the procedure NYHA class: 2-3,Z. Hijazi, TCT 2008,Edward-Sapien Valve Experience Initial Results,7/8 Successful percutaneous delivery 1/8: valve position was not ideal; valve migrated; surgical retrieval and “perventricular valve implantation” off bypass Acute Reduction of Gradients pre 10-40 mm Hg post 10-25 mm Hg No PI,Z. Hijazi, TCT 2008,Summary,Initial Experience from percutaneous PV replacement is very encouraging. It confirms the importance of patient selection, imaging and close follow up in the development of percutaneous therapies of valvular interventions.,
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