常见先心病、瓣膜疾病介入治疗技术规范、远期疗效及新技术临床应用研究
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摘要
第一部分常见先心病、瓣膜疾病介入治疗技术规范、远期疗效及新技术临床应用研究
背景和目的随着技术的进步,先天性心脏病的介入治疗正在处在快速发展阶段,我国先天性心脏的介入治疗例数逐年增加。本研究旨在评价常见先天性心脏病(包括ASD、VSD、PDA和PS)和瓣膜疾病介入治疗的安全性和有效性,评估介入治疗的近、中、远期效果,并同时研究新技术和新材料在先心病介入治疗中的应用,为建立我国的先心病和瓣膜疾病介入治疗规范积累资料。
材料和方法以2009年5月至2009年8月上海市中山医院心血管内科住院接受介入封堵治疗的107例患者为研究对象,其中包括房间隔缺损(ASD)患者55例；室间隔缺损(VSD)患者26例；动脉导管未闭(PDA)患者19例；肺动脉瓣狭窄(PS)患者4例；二尖瓣狭窄(MS)患者3例。对每位患者个体化选择介入治疗方案,研究介入治疗的效果和并发症。对比术前术后24小时、1个月、3个月、6个月超声心动图测量指标的变化,了解介入治疗对心脏结构重塑和血流动力学的影响,观察新材料和新方法的对患者的安全性和有效性。经胸超声心动图(TTE)测量指标有：房缺边缘至上腔静脉(SVC)、下腔静脉(IVC)、主动脉瓣(AV)、二尖瓣(MV)的距离；VSD距主动脉瓣(AV)、三尖瓣(TM)距离。瓣膜反流,左心室舒张末期内径(LVDd),右心房左右径(RADtr),左心室射血分数(LVEF),左房前后径(LADap)。跨肺动脉瓣压差(PVG),跨二尖瓣压差(MVG),二尖瓣口面积(MVA),肺动脉收缩压(PASP)等。
结果55例ASD患者中共有53例患者封堵成功,其中1例患者封堵器脱落回收后再次封堵成功,封堵技术成功率为96.36%。2例失败,严重并发症2例。26例VSD患者共25例成功进行封堵治疗,技术成功率96.15%,1例失败,无房室传导阻滞等严重并发症。19例PDA患者均封堵成功,技术成功率100%,包括3例巨大PDA患者,严重并发症1例。4例PS患者术后跨瓣压差明显降低,心功能改善,临床症状消失。3例MS患者2例临床症状、心功能改善,3例患者二尖瓣口面积均不同程度增加。所有患者术后心腔内径缩小,心脏重塑改善,肺动脉收缩压降低,心功能改善。各组在术后24小时变化最大,和术前相比较有统计学意义(P<0.05)。
结论在选择合适的病人当中,常见先心病和瓣膜疾病介入治疗安全有效,近期、短期随访效果良好。
手术有一定的并发症,需要严格掌握适应症,介入治疗操作过程要正确规范,需要在大的医疗中心开展。
第二部分房间隔瘤并发继发孔型房间隔缺损的介入治疗
背景和目的房间隔缺损并发房间隔瘤是房间隔缺损介入治疗的一种特殊类型。本研究为了评价房间隔瘤(ASA)合并继发孔型房间隔缺损(ASD)介入治疗的安全性和有效性。
材料和方法2007年1月～2009年3月连续介入封堵治疗ASA合并Ⅱ孔型ASD患者19例,男性7例,女性13例,年龄20-72(43±14.9)岁。经症状、胸片、心电图、经胸心脏超声(TEE)证实为ASA合并Ⅱ孔型ASD,瘤体均凸向右房。测量瘤底直径15～29(21.7±3.9)mm,ASD直径3-28(13.1±6.6)mm。其中单孔型ASD14例,2孔型ASD2例,多孔型ASD3例。空间距离小于7mml例,大于7mm4例。
结果19例患者18例一次封堵成功,1例2次封堵成功。技术成功率100%。封堵器直径14-34(22.1±6.9)mm,所有患者均植入一个封堵器。术后即刻TTE检查穿隔血流消失,ASD完全闭合率100%。术后1-12月随访,患者右心房右心室恢复正常大小17例,2例右房室缩小,无封堵器移位和其他并发症。
结论ASA合并继发孔型ASD介入治疗安全可行。
Part one:Standard study on technical regulation of interventional therapy of common congenital heart disease and valve diease、long-term effect and clinical application of new technologies
Bcakground and Objective
With advance in technology,transcatheter interventional therapy for congenital heart dieases is in a rapid development stage,the number of interventional cases in our country increased rapidly year by year.This study is in order to evaluate the clinical efficiency and safety of transcatheter interventional therapy for common congenital heart dieases(including ASD、VSD、PDA、PS) and valve dieases,assess effects of intervention in short-time、medium-time and long-time follow up,at the same time,we study on clinical application of new technologies and new materials in interventional therapy for congenital heart dieases, accumulate clinical datas for guidelines of transcatheter interventional therapy for congenital heart dieases and valve dieases.
Material and methods
One hundred and seven consecutive patients who underwent transcatheter interventional therapy from May.2009 to Aug.2009 were including in this study,including 55 patients with ASD、26 patients with VSD、19 patients with PDA、4 patients with PS、3 patients with MS.We selected personalized interventional protocol for each patient,and focused on clinical effects and complications of intervention.We studied changes about TTE variations preoperatively and postperatively(24 hours、1 month、3 months、6 months after the procedure),for to understand effects of the operations on cardiac structural remodeling and hemodynamics,and observed clinical efficiency and safety of new technologies and new materials.TTE test include distance of VSD to SVC、IVC、AV、MV;distance of VSD to AV、MV;valve regurgitation;LVDd、RADtr、LVEF、LADap、PVG、MVG、MVA、PASP and other datas.
Results
In 55 patients with ASD,ASD was closed successfully in 53 patients(technique success rate:96.36%), one patient's occluder droped after operation,we retrieved occluder and replaced another occluder successfully. severe complicatioms was happened on 2 paytients.In 26 patients with VSD,VSD was closed successfully in 25 patients(technique success rate:96.15%),without any severe complications such as A-V block, severe complicatioms was happened on one patients.In 19 patients with PDA, PDA was closed successfully in 19 patients(technique success rate: 100%),including 3 patients with huge PDA, severe complicatioms was happened on one patients.In 4patients with PS, pressu re gradient across the pulmonary valve decreased immediately after PBPV,cardiac functions and clinical symptoms of patients improved.In 3 patients with MS, cardiac functions and clinical symptoms of 2 patients improved after PBMV,mitral valve area of three patients was enlarged in different level. After procedure,heart chamber diameter of all patients diminished and cardiac structural remodeling improved,the PASP decreased,result in improving global cardiac functions. The greatest change of datas in each group happened 24 hours after operation,there has statistic significance between 24 hours postoperatively and preoperatively.
Conclusions
In the patients selected, transcatheter interventional therapy for congenital heart dieases and valve dieases is safe and effective,short-time and medium-time follow up show great outcome.
Intervention has some complications,including severe complications,so we need to control indication strictly,procedure must be correct and standard,these procedure must be taken in major medical center.
Part two:Interventional therapy of atrial septal aneurysm associated with secondum atrial septal defect
Bcakground and Objective
atrial septal aneurysm associated with secondum atrial septal defect is specific field in intervention of ASD. This study is designed for evaluating the safety and efficiency of transactheter closure of atrial septal aneurysm(ASA) associated with secoundum atrial septal defect (ASD).
Material and methods
we investigated 19 patients,aged from 20-72(average:43±14.9) years old. All patients were diagnosed of ASA associated with ASD by physical examination, X ray and TTE. AS As were all convexed into right atrial. The largest diameter of ASA was from 15 to 29 (average:21.7±3.9) mm,the largest diameter of ASD was from 3-28(average: 13.1±6.6)mm.14 cases were single hole ASD,2 cases were two hole ASD and 3 cases with multiple holes ASD.1 case with the distance between each ASD holes was less than 7mm, and 4 case with the distance between each ASD holes was more than 7 mm.
Results
18 cases were successfully occluded just for once,and 1 case occluded for two try,and the technique success rate was 100%. The sizes of implanting occluders were from 14 to 34 (average,22.1±6.9).A11 of patients were implanted only one occluder to to close ASD hole. Immediately after occlusion, examined by TTE, transseptal blood was disappear,ASD was completely closed in all 19 cases. During 1～12 months followed up, heart size resumed to normal in 17 cases (89.5%). Another 2 cases right heart sizes were decreased. None was found occluder shift and other complications.
Conclusions
Interventional therapy of ASA associated with ASD is safe and feasible.
背景和目的随着技术的进步,先天性心脏病的介入治疗正在处在快速发展阶段,我国先天性心脏的介入治疗例数逐年增加。本研究旨在评价常见先天性心脏病(包括ASD、VSD、PDA和PS)和瓣膜疾病介入治疗的安全性和有效性,评估介入治疗的近、中、远期效果,并同时研究新技术和新材料在先心病介入治疗中的应用,为建立我国的先心病和瓣膜疾病介入治疗规范积累资料。
材料和方法以2009年5月至2009年8月上海市中山医院心血管内科住院接受介入封堵治疗的107例患者为研究对象,其中包括房间隔缺损(ASD)患者55例；室间隔缺损(VSD)患者26例；动脉导管未闭(PDA)患者19例；肺动脉瓣狭窄(PS)患者4例；二尖瓣狭窄(MS)患者3例。对每位患者个体化选择介入治疗方案,研究介入治疗的效果和并发症。对比术前术后24小时、1个月、3个月、6个月超声心动图测量指标的变化,了解介入治疗对心脏结构重塑和血流动力学的影响,观察新材料和新方法的对患者的安全性和有效性。经胸超声心动图(TTE)测量指标有：房缺边缘至上腔静脉(SVC)、下腔静脉(IVC)、主动脉瓣(AV)、二尖瓣(MV)的距离；VSD距主动脉瓣(AV)、三尖瓣(TM)距离。瓣膜反流,左心室舒张末期内径(LVDd),右心房左右径(RADtr),左心室射血分数(LVEF),左房前后径(LADap)。跨肺动脉瓣压差(PVG),跨二尖瓣压差(MVG),二尖瓣口面积(MVA),肺动脉收缩压(PASP)等。
结果55例ASD患者中共有53例患者封堵成功,其中1例患者封堵器脱落回收后再次封堵成功,封堵技术成功率为96.36%。2例失败,严重并发症2例。26例VSD患者共25例成功进行封堵治疗,技术成功率96.15%,1例失败,无房室传导阻滞等严重并发症。19例PDA患者均封堵成功,技术成功率100%,包括3例巨大PDA患者,严重并发症1例。4例PS患者术后跨瓣压差明显降低,心功能改善,临床症状消失。3例MS患者2例临床症状、心功能改善,3例患者二尖瓣口面积均不同程度增加。所有患者术后心腔内径缩小,心脏重塑改善,肺动脉收缩压降低,心功能改善。各组在术后24小时变化最大,和术前相比较有统计学意义(P<0.05)。
结论在选择合适的病人当中,常见先心病和瓣膜疾病介入治疗安全有效,近期、短期随访效果良好。
手术有一定的并发症,需要严格掌握适应症,介入治疗操作过程要正确规范,需要在大的医疗中心开展。
第二部分房间隔瘤并发继发孔型房间隔缺损的介入治疗
背景和目的房间隔缺损并发房间隔瘤是房间隔缺损介入治疗的一种特殊类型。本研究为了评价房间隔瘤(ASA)合并继发孔型房间隔缺损(ASD)介入治疗的安全性和有效性。
材料和方法2007年1月～2009年3月连续介入封堵治疗ASA合并Ⅱ孔型ASD患者19例,男性7例,女性13例,年龄20-72(43±14.9)岁。经症状、胸片、心电图、经胸心脏超声(TEE)证实为ASA合并Ⅱ孔型ASD,瘤体均凸向右房。测量瘤底直径15～29(21.7±3.9)mm,ASD直径3-28(13.1±6.6)mm。其中单孔型ASD14例,2孔型ASD2例,多孔型ASD3例。空间距离小于7mml例,大于7mm4例。
结果19例患者18例一次封堵成功,1例2次封堵成功。技术成功率100%。封堵器直径14-34(22.1±6.9)mm,所有患者均植入一个封堵器。术后即刻TTE检查穿隔血流消失,ASD完全闭合率100%。术后1-12月随访,患者右心房右心室恢复正常大小17例,2例右房室缩小,无封堵器移位和其他并发症。
结论ASA合并继发孔型ASD介入治疗安全可行。
Part one:Standard study on technical regulation of interventional therapy of common congenital heart disease and valve diease、long-term effect and clinical application of new technologies
Bcakground and Objective
With advance in technology,transcatheter interventional therapy for congenital heart dieases is in a rapid development stage,the number of interventional cases in our country increased rapidly year by year.This study is in order to evaluate the clinical efficiency and safety of transcatheter interventional therapy for common congenital heart dieases(including ASD、VSD、PDA、PS) and valve dieases,assess effects of intervention in short-time、medium-time and long-time follow up,at the same time,we study on clinical application of new technologies and new materials in interventional therapy for congenital heart dieases, accumulate clinical datas for guidelines of transcatheter interventional therapy for congenital heart dieases and valve dieases.
Material and methods
One hundred and seven consecutive patients who underwent transcatheter interventional therapy from May.2009 to Aug.2009 were including in this study,including 55 patients with ASD、26 patients with VSD、19 patients with PDA、4 patients with PS、3 patients with MS.We selected personalized interventional protocol for each patient,and focused on clinical effects and complications of intervention.We studied changes about TTE variations preoperatively and postperatively(24 hours、1 month、3 months、6 months after the procedure),for to understand effects of the operations on cardiac structural remodeling and hemodynamics,and observed clinical efficiency and safety of new technologies and new materials.TTE test include distance of VSD to SVC、IVC、AV、MV;distance of VSD to AV、MV;valve regurgitation;LVDd、RADtr、LVEF、LADap、PVG、MVG、MVA、PASP and other datas.
Results
In 55 patients with ASD,ASD was closed successfully in 53 patients(technique success rate:96.36%), one patient's occluder droped after operation,we retrieved occluder and replaced another occluder successfully. severe complicatioms was happened on 2 paytients.In 26 patients with VSD,VSD was closed successfully in 25 patients(technique success rate:96.15%),without any severe complications such as A-V block, severe complicatioms was happened on one patients.In 19 patients with PDA, PDA was closed successfully in 19 patients(technique success rate: 100%),including 3 patients with huge PDA, severe complicatioms was happened on one patients.In 4patients with PS, pressu re gradient across the pulmonary valve decreased immediately after PBPV,cardiac functions and clinical symptoms of patients improved.In 3 patients with MS, cardiac functions and clinical symptoms of 2 patients improved after PBMV,mitral valve area of three patients was enlarged in different level. After procedure,heart chamber diameter of all patients diminished and cardiac structural remodeling improved,the PASP decreased,result in improving global cardiac functions. The greatest change of datas in each group happened 24 hours after operation,there has statistic significance between 24 hours postoperatively and preoperatively.
Conclusions
In the patients selected, transcatheter interventional therapy for congenital heart dieases and valve dieases is safe and effective,short-time and medium-time follow up show great outcome.
Intervention has some complications,including severe complications,so we need to control indication strictly,procedure must be correct and standard,these procedure must be taken in major medical center.
Part two:Interventional therapy of atrial septal aneurysm associated with secondum atrial septal defect
Bcakground and Objective
atrial septal aneurysm associated with secondum atrial septal defect is specific field in intervention of ASD. This study is designed for evaluating the safety and efficiency of transactheter closure of atrial septal aneurysm(ASA) associated with secoundum atrial septal defect (ASD).
Material and methods
we investigated 19 patients,aged from 20-72(average:43±14.9) years old. All patients were diagnosed of ASA associated with ASD by physical examination, X ray and TTE. AS As were all convexed into right atrial. The largest diameter of ASA was from 15 to 29 (average:21.7±3.9) mm,the largest diameter of ASD was from 3-28(average: 13.1±6.6)mm.14 cases were single hole ASD,2 cases were two hole ASD and 3 cases with multiple holes ASD.1 case with the distance between each ASD holes was less than 7mm, and 4 case with the distance between each ASD holes was more than 7 mm.
Results
18 cases were successfully occluded just for once,and 1 case occluded for two try,and the technique success rate was 100%. The sizes of implanting occluders were from 14 to 34 (average,22.1±6.9).A11 of patients were implanted only one occluder to to close ASD hole. Immediately after occlusion, examined by TTE, transseptal blood was disappear,ASD was completely closed in all 19 cases. During 1～12 months followed up, heart size resumed to normal in 17 cases (89.5%). Another 2 cases right heart sizes were decreased. None was found occluder shift and other complications.
Conclusions
Interventional therapy of ASA associated with ASD is safe and feasible.
引文
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