食道超声引导下经胸小切口封堵术治疗复合型先天性心脏病的临床研究

发布时间：2018-04-24 09:02

本文选题：先天性心脏病 + 经胸微创封堵术　；参考：《山东大学》2016年博士论文

【摘要】：研究背景近年来,先天性心脏病已成为导致新生儿死亡的最常见先天性畸形。最新统计数据显示,在全球范围内,每1000个活产婴儿中就有8-12人罹患先天性心脏病。而在我国,1岁婴儿中先天性心脏病发病率已逐年增加至1.11%,其中室间隔缺损、动脉导管未闭以及房间隔缺损是三种最常见的先心病。在一些患者中,常常存在两种或两种以上心脏畸形合并存在的情况。患者并存两种或两种类型以上需要治疗的心血管病变或畸形即为复合型先天性心脏病。复合型先天性心脏病并不少见,大约有50%手术治疗的室间隔缺损病例有其他畸形合并存在,合并粗大或中等动脉导管未闭者占6%,其中25%有心功能不全;合并房间隔缺损者占17%；而在房间隔缺损患者中有10%合并肺动脉瓣狭窄,5%合并室间隔缺损,3%合并动脉导管未闭。室间隔缺损合并房间隔缺损、房间隔缺损合并动脉导管未闭,以及室间隔缺损合并动脉导管未闭通常不被归类为严重的合并畸形,但一些婴幼儿患者其肺部充血状态常常较严重,应引起足够重视,需早期纠正。全麻体外循环下开胸直视手术是治疗复合型先天性心脏病的金标准。但是,这种治疗方法本身存在不少缺陷,比如需心肺转流、主动脉钳夹阻断、手术创伤大、恢复时间长等。在此背景下,经皮介入技术逐渐发展起来。但是,这种介入治疗方法本身也存在值得注意的缺陷,例如需长时间的心导管插入、需放射线的照射、增加房室传导阻滞风险、损伤主动脉及心脏瓣膜、以及对患者血管通路条件要求较高。在过去的二十年中,随着新专业技术知识的不断发展,食道超声引导下经胸小切口封堵术迅速发展并已经成为治疗先天性心脏病的新选择。先前的大量文献报道中,已经证实了这种新技术在治疗单一先心病(尤其是单一室间隔缺损、动脉导管未闭和房间隔缺损)中的安全性及有效性。但是有关这种方法同期治疗复合型先天性心脏病的研究较少,且具体手术方法及路径尚无定论。研究目的通过本研究全面总结分析食道超声引导下经胸小切口封堵术治疗复合型先天性心脏病的手术方法、手术的可行性以及其安全性,对几种不同手术方案的优缺点进行比较,为临床推广复合型先天性心脏病的食道超声引导下经胸小切口封堵治疗提供借鉴。研究方法2010年2月至2016年7月,山东省立医院心外科共有60例复合型先天性心脏病患者接受了食道超声引导下经胸小切口封堵术治疗。其中男性25例,女性35例。患者年龄4月至39岁(年龄中位数35.5月),其中1岁以内患者17例(28.3%),1-5岁患者34例(56.7%)。体重5.5-65kg(体重中位数13kg)。经胸超声心动图检查诊断,VSD合并ASD患者27例,VSD合并PDA患者16例,PDA合并ASD患者15例,VSD、ASD和PDA三种畸形同时并存患者2例。45例合并VSD的患者中膜周部室间隔缺损41例,干下型室间隔缺损4例；44例患者合并房间隔缺损,均为继发孔型,2例为双孔型房间隔缺损。33例合并PDA患者中,31例PDA为管状,1例为窗型、1例为漏斗状。房、室间隔分流信号为左向右分流。无中、重度心脏瓣膜反流,无心脏瓣膜器质性病变。患者的纳入标准及排除标准：1.纳入标准：(1)超声心动图确诊ASD、VSD、PDA,且边缘良好,有封堵可能；(2)未合并需要同期体外循环下外科手术纠正的其他心血管畸形。2.排除标准：(1)超声心动图提示心脏瓣膜有中度以上的反流或脱垂；(2)合并有其他需体外循环下手术的先天性心脏病；(3)仅存在单一畸形；(4)已经确诊为艾森曼格综合征,或经胸超声心动图彩色多普勒血流显像显示心内缺损处血流呈右向左分流；(5)术前有尚未纠正的心力衰竭；(6)合并感染性心内膜炎；(7)有抗凝或抗血小板禁忌证患者。在全麻气管插管下实施手术,术前经食道超声心动图检查,明确心脏畸形类型、大小,边缘情况,并实时监控整个封堵过程。根据经食道超声心动图结果,选择合适的封堵器及输送系统备用。根据患者的不同合并畸形,将其分为4组：第1组为室间隔缺损合并房间隔缺损；第2组为室间隔缺损合并动脉导管未闭；第3组为房间隔缺损合并动脉导管未闭；第4组为同时合并室间隔缺损、房间隔缺损及动脉导管未闭三种畸形。根据患者心脏畸形的诊断、类型、部位及合并畸形组合情况、封堵难易程度选择不同的手术切口及手术路径,其中,第1组患者分别采用经右胸-右房途径、经胸骨下段正中-右室、右房途径、经左胸-右室联合经皮介入途径；第2组患者采用胸骨下段正中-右室、肺动脉途径；第3组患者采用左胸-肺动脉联合右胸-右房途径；第4组采用胸骨正中-右室、右房、肺动脉途径。术后1、3、6、12个月及此后每年一次随访。对封堵器的位置、稳定性、是否存在残余分流及封堵造成的新发心脏瓣膜并发症进行评估。所得数据均采用SPSS19.0统计软件进行统计学分析。数值变量资料以中位数或X±S表示。各项观察指标间的两两比较方法采用配对单因素方差分析F检验、或卡方检验进行。显著性水平取0.05,结果比较用P值,P0.05认为差异无统计学意义,P0.05认为差异具有统计学意义。结果本研究60例复合型先天性心脏病患者全部封堵成功(100%),共成功植入122枚封堵器,55例患者(91.7%)封堵器一次性植入成功,全部122次封堵器植入操作一次性植入成功率为95.9%。全部患者平均手术时间为77.9±28.9min(42-165分钟)。VSD封堵时间约12.1±9.8min(4-55min)、ASD封堵时间7.0±4.0min(2-17min)、PDA封堵时间7.4±4.4min(2-17min)。所有患者于手术后24小时内拔除气管内插管,呼吸辅助时间226.1±172.8(79-1020)分钟；ICU观察时间20.3±5.0(16-39)小时；术后住院5.4±1.5(3-8)天。随访期间经胸超声心动图检查未见ASD、PDA残余分流。VSD封堵后残余分流3例,均在随访3月至1年消失。术后新出现主动脉瓣反流3例,二尖瓣少量反流2例,三尖瓣反流2例。2例患者封堵后出现不完全性右束支传导阻滞,术后第3月消失恢复正常心电图。所有患者随访期间均未行再次手术。包括感染性心内膜炎、房室传导阻滞、血栓栓塞、主动脉瓣及房室瓣损伤、死亡等在内的严重并发症发生率为0。全部封堵器均无移位,且无周围组织损伤。结论本研究证实了食道超声引导下经胸小切口封堵术治疗复合型先天性心脏病的可行性,该方法未增加手术并发症风险,未降低封堵成功率。食道超声引导下经胸小切口封堵术治疗的关键在于不同手术路径的灵活选择、根据不同心脏畸形组合调整封堵顺序、手术者的熟练操作、超声医师的精准评估、详尽高效的备用方案的保驾护航。食道超声引导下经胸小切口封堵术对复合型先天性心脏病患者的治疗相对其他治疗方法有明显优势：与传统手术方式比较,该方法无需体外循环,手术切口小,创伤小,手术时间短,呼吸机辅助时间短,术后恢复时间短,并发症少；与介入方法比较,其无需X线暴露及造影剂、无体重及年龄限制、无血管条件限制、手术方案灵活、封堵方法简单易掌握、一旦封堵失败更能迅速改变手术方式确保患者生命安全。虽然存在以上优势,但该治疗方法仍有不足：手术中仍需气管插管全身麻醉、有时需2个手术切口且仍有病例需劈开胸骨增加了手术创伤。室间隔缺损合并房间隔缺损患者主要根据VSD的位置、形态、封堵的难易程度决定手术方案。合并的膜周部VSD直径在2.0-7mm之间、或合并中间型mVSD、无需置入偏心型封堵器者采用右胸-右房单穿刺点手术方式。合并直径2.0mm或7mm膜周部VSD、或心尖部VSD者推荐选择经胸骨正中切口,经右心室封堵VSD、经右心房封堵ASD。合并干下型VSD者选择左胸-右室途径封堵VSD,经右胸-右房或经皮封堵ASD。手术方案选择的原则是创伤小优先、不纵劈胸骨优先、单穿刺点优先。我们根据心内畸形纠正的难易程度及封堵并发症风险的高低决定封堵顺序。一般情况下首先对难度最高、风险最高的缺损进行封堵。一旦封堵失败,尽早转为体外循环直视下修补术。尽管本研究的结果令人鼓舞,但仍有存在病例样本数量少、随访时间短、非随机对照实验等不足。
[Abstract]:In recent years, congenital heart disease (congenital heart disease) has become the most common congenital malformation causing death of the newborn. The latest statistics show that 8-12 of every 1000 live births have congenital heart disease worldwide. In our country, the incidence of congenital heart disease in 1 year old infants has increased to 1.11%, of which the ventricular septum is interventricular septum. Defects, patent ductus arteriosus, and atrial septal defect are three of the most common congenital heart diseases. In some patients, there are often two or more than two types of cardiac malformation. Patients with two or more than two types of cardiovascular disease or malformation are complex congenital heart disease. Complex congenital heart disease. It is not uncommon that about 50% cases of ventricular septal defect with surgical treatment are associated with other malformations, including 6% with large or medium patent ductus arteriosus, 25% of which have cardiac insufficiency, 17% with atrial septal defect, 10% with pulmonary stenosis, 5% with ventricular septal defect and 3% in combination with atrial septal defect. Ventricular septal defect, atrial septal defect combined with atrial septal defect, atrial septal defect with patent ductus arteriosus, ventricular septal defect combined with patent ductus arteriosus are often not classified as severe amalgamative malformation. However, some infants and young children are often more congested in their lungs and should be paid enough attention to early correction. General anesthesia extracorporeal circulation Open open chest surgery is the gold standard for the treatment of complex congenital heart disease. However, there are many defects in this method, such as cardiopulmonary bypass, aortic clamp blocking, surgical trauma, and long recovery time. In this context, percutaneous interventional techniques are gradually developed. However, this interventional therapy itself also exists. Noticeable defects, such as long cardiac catheterization, radiation of radiation, increased risk of atrioventricular block, injury of aorta and heart valves, and higher requirements for vascular access conditions in patients. In the past twenty years, with the continuous development of new professional knowledge, small incision closure under esophagus ultrasound guidance The rapid development of surgery has become a new choice for the treatment of congenital heart disease. The safety and effectiveness of this new technique in the treatment of single congenital heart disease (especially single ventricular septal defect, patent ductus arteriosus, and atrial septal defect) has been confirmed in a large number of previous reports. There are few studies on congenital heart disease, and the specific surgical methods and paths are not conclusive. The purpose of this study is to summarize and analyze the operative methods, the feasibility and safety of the small incision closure of the esophagus under the esophagus ultrasound guidance, and the advantages and disadvantages of several different surgical schemes. From February 2010 to July 2016, 60 patients with complex congenital heart disease in Shangdong Province-owned Hospital heart surgery received the treatment of small incision closure under the esophagus ultrasound guidance. Among them, 25 cases were male. 35 women aged from April to 39 years (median age 35.5 months), 17 (28.3%) in 1 years of age, 34 (56.7%) in 1-5 years of age, weight 5.5-65kg (median weight 13kg). Transthoracic echocardiography, 27 cases of VSD with ASD, 16 in VSD with PDA, 15 in PDA with ASD, VSD, ASD, and PDA of three deformities simultaneously There were 41 cases of peripheral ventricular septal defect in 2.45 patients with VSD, 4 cases of interdry ventricular septal defect, 44 cases with atrial septal defect, secondary pass, 2 case of double hole atrial septal defect in.33 and PDA, 31 cases of PDA as tube, 1 cases with window type and 1 cases of funnel like. Room and ventricular septal shunt signal were left to right Flow. No medium, severe heart valve reflux, no heart valve organic lesions. Inclusion criteria and exclusion criteria for patients: 1. inclusion criteria: (1) echocardiography confirmed ASD, VSD, PDA, well edge, blocking possibility; (2) other.2. exclusion criteria that need to be corrected by external cardiopulmonary bypass surgery at the same time: (1) super Echocardiography indicated that the heart valve had a moderate reflux or prolapse; (2) there were other congenital heart diseases that needed to be operated under extracorporeal circulation; (3) there was only a single deformity; (4) the diagnosis of Eisen Mange's syndrome, or the transthoracic echocardiography color Doppler flow imaging, showed that the blood flow in the heart defect was right to left shunt; 5) heart failure before operation; (6) combined infective endocarditis; (7) patients with anticoagulant or antiplatelet taboo. Operation under general anesthesia and tracheal intubation, preoperative transesophageal echocardiography, clear type, size, edge condition of cardiac malformation, and real-time monitoring of the whole process of occlusion. According to transesophageal echocardiography As a result, the appropriate occluder and delivery system were selected. According to the patients' different amalgamative malformation, they were divided into 4 groups: first groups were ventricular septal defect with atrial septal defect, the second group was ventricular septal defect with patent ductus arteriosus, the third was atrial septal defect combined with arterial conduit, and the fourth group was combined with ventricular septal defect at the same time. Three kinds of malformation of atrial septal defect and patent ductus arteriosus. According to the diagnosis, type, location and combination of deformity of the patients with cardiac malformation, different surgical incision and surgical path were selected. Among them, the first groups were treated by right chest to right atrium through the lower sternum right ventricle, right chamber via the left chest and right ventricle. The second groups of patients were treated with the middle and right ventricle of the lower segment of the sternum, the pulmonary artery pathway, the third groups were combined with the left thoracic and pulmonary artery and right chest right atrial pathway, the fourth group adopted the median sternum right ventricle, the right atrium, the pulmonary artery approach. 1,3,6,12 months after operation and subsequent follow-up. The new heart valve complications were evaluated by residual shunt and occlusion. The data were statistically analyzed by SPSS19.0 software. The data of the numerical variables were expressed as median or X S. The 22 comparison methods between the various observation indexes were performed by paired single factor analysis of variance F test, or chi square test. The results were 0.05, and the results were compared with the P value. P0.05 thought the difference was not statistically significant, and P0.05 thought the difference was statistically significant. Results all the 60 patients with complex congenital heart disease were successfully blocked (100%), 122 occluders were successfully implanted, 55 patients (91.7%) were implanted successfully and all 122 occluders were implanted. The average time of one time implantation was 95.9%., the average operation time was 77.9 + 28.9min (42-165 minutes),.VSD plugging time was 12.1 + 9.8min (4-55min), ASD blocking time was 7 + 4.0min (2-17min), and PDA occlusion time was 7.4 + 4.4min (2-17min). All patients were removed endotracheal intubation at 24 hours after operation, and the respiration assisted time was 226.1 + 172.8 (79-10). 20) minutes; ICU observation time was 20.3 + 5 hours (16-39) hours and postoperative hospitalization was 5.4 + 1.5 (3-8) days. There were no ASD and 3 remnants of residual shunt with PDA residual shunt during the follow-up period. All the patients were followed up for March to 1 years. 3 cases of aortic regurgitation, 2 cases of mitral regurgitation and three apex regurgitation in.2 patients after operation were followed up. Incomplete right bundle branch block was found after closure, and the normal electrocardiogram was recovered third months after the operation. All patients had no reoperation during the follow-up period. The incidence of severe complications, including infective endocarditis, atrioventricular block, thromboembolism, aortic valve and atrioventricular valve injury, and death, was 0.. Conclusion this study confirms the feasibility of treating complex congenital heart disease with small incision closure under esophagus ultrasound guidance. This method does not increase the risk of surgical complications and does not reduce the success rate of occlusion. The key to the treatment of small incision closure under the guidance of esophagus ultrasound guidance is the spirit of different surgical paths. The choice of live selection is to adjust the closure sequence according to the combination of different cardiac malformations, the skilled operation of the surgeon, the accurate evaluation of the ultrasonic physician, and the careful and effective reserve plan. The treatment of complex congenital heart disease by the esophagus ultrasound guidance is obviously superior to the other treatment methods for the patients with complex congenital heart disease: with the traditional hands. There was no need of external circulation, small incision, small wound, short operation time, short time of operation, short time of ventilator, short recovery time and less complications. Compared with the interventional method, no X-ray exposure and contrast agent, no weight and age limit, no blood tube condition, flexible operation plan, simple and easy mastery of blocking method, were not needed. The failure of denier blocking can quickly change the way of operation to ensure the safety of the patient. Although there are above advantages, there is still a shortage of the treatment method: the operation still needs general anesthesia for tracheal intubation, sometimes 2 surgical incisions are needed and the cases still need to split the sternum to increase the surgical trauma. The position, shape, and the difficulty of occlusion determine the operation plan. The VSD diameter of the peripheral membrane of the VSD is between 2.0-7mm, or the intermediate type mVSD, and the right chest and right atrial single puncture point operation is not needed for the eccentricity occluder. The VSD of the diameter 2.0mm or the 7mm membrane, or the apical VSD, is recommended by the median sternum incision and right through right Ventricular blockage of VSD, transcatheter closure of ASD. with right atrium and sub dry VSD, the choice of left chest right ventricular blocking VSD, the principle of selection by right chest right atrium or percutaneous blocking ASD. operation is small trauma priority, no longitudinal split sternum priority, single puncture point priority. We depend on the degree of intracardiac correction and the risk of blocking complications. In general, the most difficult and most risky defect is blocked. Once the closure fails, it is converted to the repair of the cardiopulmonary bypass as early as possible. Although the results of this study are encouraging, there are still fewer case samples, short follow-up time, and the inadequacy of the non machine control experiment.

【学位授予单位】：山东大学
【学位级别】：博士
【学位授予年份】：2016
【分类号】：R725.4

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