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胸腔镜技术在心脏外科的临床应用研究
The Clinical Study of Totally Thoracoscopic Cardiac Surgery Without A Robotecally Assisted Surgical System
【作者】 马增山;
【导师】 吴树明;
【作者基本信息】 山东大学 , 胸心外, 2014, 博士
【摘要】 研究目的:科学评价胸腔镜技术应用于室间隔缺损修补术、二尖瓣置换术的可行性、安全性,以及微创和美容效果,验证胸腔镜下心脏手术模式的可靠性和手术、临床处理规范,为胸腔镜技术在心脏外科的应用推广奠定理论和临床基础。研究方法:1.一般临床资料病例的选择遵守常规直视手术适应症的原则,年龄限制在2-65岁,体重15~80kg,肺动脉压在中度(60mmHg)以下,没有肺部疾病和右胸部手术病史,没有胸膜炎和细菌性心内膜炎病史,手术前股动、静脉多普勒检查无明显畸形。第一部分入选病例:自2011年9月至2014年3月于山东大学齐鲁医院和聊城市人民医院心外科的住院患者119例,年龄2-48岁,平均7.1±3.6岁,男性66例,女性53例,体重14-88公斤,平均32.4±7.8公斤,膜周部室间隔缺损55例,膜部室间隔缺损64例,常规胸部CT检查或胸部X光拍片检查未发现明显异常,肺功能正常,髂-股动脉、静脉无畸形,合并肺动脉高压者48例,肺动脉压超过60mmHg11例。合并有卵圆孔未必9例。同时间选择常规直视室间隔缺损修补术病例35例作为对照组,患者年龄、男性比、体重、室间隔缺损大小以及合并肺动脉高压比率与研究组病人无明显的差别(P>0.05)。第二部分本研究所入选临床病例来自2011年10月至2014年3月期间,齐鲁医院和聊城市人民医院的住院病人,选择标准:(1)心功能纽约分级为Ⅰ-Ⅱ级;(2)年龄于15岁以上,体重大于45公斤;(3)没有左心房血栓;(4)肺动脉压力<60mmHg;(5)没有肺部疾病和有胸部手术史:(6)手术前股动、静脉多普勒检查无明显畸形。在196例二尖瓣病变患者中,选择了62例作为本实验组,62例病人中有27例男性,35例女性,年龄28~65岁,平均51.7±5.6岁,体重48~90公斤,平均66.4±6.7公斤,超声心动图检查诊断为单纯二尖瓣狭窄39例,单纯二尖瓣反流10例,二尖瓣狭窄合并关闭不全13例。28例合并有轻度度肺动脉高压(30-40mmHg),13例合并有中度肺动脉高压(40-59mmHg)。选择同期常规心脏直视手术的患者36例作为对照组,其性别、年龄、体重及二尖瓣病变程度以及肺动脉高压情况与研究组经统计学分析无显著差异(P>0.05)。2.手术方法患者取仰卧位,右侧垫高15-20度,左前胸和右后胸壁贴体外除颤电极。常规采用全身麻醉双腔气管内插管或单腔气管插管,双腔气管插管胸腔内操作时,采用左单肺通气;单腔气管插管胸腔内操作时,采用减低潮气量、增加呼吸频率,保持分钟通气量的通气原则。外周体外循环的建立:采用股动脉、股静脉插管建立体外循环。胸壁三孔:第一孔为左手操作器械入孔,于胸骨右缘第三或四肋间,长1cm;第二孔为右手操作器械入孔,于右锁骨中线外侧第五或六肋间,长1~1.5cm;第三孔为胸腔镜入口,于右腋中线第四或五肋间,长约1.5~2cm。相应位置切孔,置入刀口保护器。第三孔入胸腔镜,调整角度和位置,于右膈神经前斜行切开心包,第一孔入组织镊子提起上腔静脉,第二孔入精细剪刀剪开上腔静脉内外侧与右肺动脉间的心包返折处,分离其间隙,第二孔入长直角钳,游离上腔静脉,套阻断带于第三孔引出;第一孔入组织镊子向右牵拉心包,第二孔入精细剪刀分离下腔静脉右侧心包返折处,第二孔入肾蒂钳,游离下腔静脉,套阻断带于第三孔引出,暴露升主动脉根部,第一孔入镊子,第二孔入持针器,带垫片双头针缝合冷灌针“U”字荷包,套阻断套管于第三孔引出。收紧上、下腔静脉阻断带,并行转机,降温。第二孔入胸腔镜,调整角度和位置,暴露好升主动脉根部,自第三孔入冷灌针,“U”字荷包线套冷灌针翼一侧,插入升主动脉根部,收紧阻断线,接灌注管。第三孔入升主动脉阻断钳,降低体外循环灌注流量,于插冷灌针远段,水平方向阻断升主动脉,灌注针灌注冷停跳液,心脏停跳。第三孔入胸腔镜,调整角度和位置,暴露右心房,第一孔入镊子,第二孔入剪刀,平行房室沟方向,剪开右心房,前、后切缘分别缝牵引线自第一孔、第三孔引出,暴露房间隔,如合并房间隔缺损给予修补。第一部分自第一孔入心室拉钩,暴露室间隔缺损,如为膜部室间隔缺损,第一孔入镊子,第二孔入持针器,4-0滑线连续缝合或补片修补室间隔缺损,体外打结推结器推入,如有房间隔缺损同时修补,膨胀肺观察有无溢血,升主动脉灌注针接负压引流排出左心系统气体,通知灌注师复温,4-0或5-0滑线连续缝合右心房切口,体外打结推结器推入。第二部分第一孔入镊子,第二孔入剪刀,平行房室沟方向,剪开右心房,前、后切缘分别缝牵引线自第一孔、第三孔引出,暴露右心房内部结构,第一孔入镊子,第二孔入剪刀,剪开房间隔,分别于房间隔切口两侧缝牵引线,暴露二尖瓣,探查二尖瓣病变情况,然后剪除二尖瓣,冲洗左心室,检查残余腱索,2-0换瓣线间断缝合自第一孔引出体外,缝合全周后,缝合线缝合人工瓣膜,收紧缝线,自第一孔推入人工瓣膜,观察人工瓣膜植入瓣环情况,完全植入后,打结器分别打结,冲洗检查人工瓣膜正常,瓣叶灵活。第一孔入组织镊子,第二孔入持针器,3~0滑线连续缝合房间隔。调整胸腔镜,暴露三尖瓣,三尖瓣打水实验,如关闭不良,第一孔入组织镊子,第二孔入持针器,间断缝合,缝合线自第一孔引出,顺序排列,缝合8针,缝合线缝合成形环,收紧缝线,推入成形环至三尖瓣,观察满意后,打结器逐个打结,打水实验关闭良好,4-0滑线连续缝合右心房切口,通知灌注师复温。第二孔入胸腔镜,调整角度和位置,暴露升主动脉根部,头低位,灌注针排气,开放升主动脉阻断钳,心脏复跳,如不复跳可用体外除颤50瓦秒除颤,拔出灌注针,灌注针荷包线胸腔外打结,推结器推入扎紧,观察有无出血,缝合心包一针,体外打结推结器推入,调整胸腔镜位置,暴露胸壁孔腔内面,检查有无出血。体外循环复温满意后,调整流量,复查动脉、静脉血气分析,各项指标正常后,逐步停机。拔出股静脉插管,中和肝素,第三孔入胸腔镜,再次观察心脏、心包和胸壁各孔有无出血,无异常后,撤出胸腔镜,缝合胸壁孔,拔出股动脉插管,6-0滑线缝合股动脉、股静脉切口,缝合皮肤,于第二孔置入胸腔闭式引流管,胸部固定一针,手术结束。3.围手术期处理(1)手术前做好健康教育,让患者主动接受这种手术方式,积极配合治疗,常规行肺功能检查,拍胸片或CT检查排除肺部疾病,指导患者进行呼吸功能的锻炼,,常规行股动脉、静脉彩色多普勒检查。(2)手术中无论采用全麻双腔气管插管左肺单肺通气还是单腔气管插管,每隔20min膨肺一次。采用高频率、小潮气量的通气模式,保证分钟通气量。(3)手术后采用低频率、高容量呼吸机辅助通气模式,加设PEEP3~5cmH2O,手术后即刻行床边拍胸部X线片,吸痰时要及时进行膨肺,密切观察胸腔闭式引流管的引流量、液面波动情况,血流动力学稳定后撤离呼吸机,早期活动。注意建立体外循环侧下肢的血运情况。4.观察指标手术时间、体外循环时间、升主动脉阻断时间、呼吸机辅助时间、住ICU时间、手术后住院时间、胸腔引流量、止痛药使用率。结果:第一部分119例患者手术顺利,全部存活,体外循环时间为54~142min,平均(66±21)min,主动脉阻闭时间25~57min,平均(33±8)min。开放升主动脉后84例心脏自动复跳,33例50w.s体外除颤复跳,早期有2例病人分别因下腔静脉出血和升主动脉根部出血而延长第二操作孔至5~6cm,改为非机器人全胸腔镜辅助下完成手术操作,术后呼吸机辅助呼吸时间为2~19h,平均(2.9±1.2)h,监护室滞留时间14-28h,平均17h,术后4~6天均分别痊愈出院。手术中食道超声证实本组病例没有残余漏发生,手术后并发症发生率为8.92%。6例(10.71%)患者给予异体血400m1,手术后引流量30-460ml(65±29ml)。随访时间1~12个月,没有并发症发生,随访时心脏超声检查未发现有残余分流,术后14~23天(平均16天)恢复上学或工作,心脏超声检查未发现有残余漏等并发症。第二部分62例患者手术顺利,无死亡,手术时间为56-99min,平均(81±11)min,体外循环转流时间为22-72min,平均(42±11)min,主动脉阻闭时间0~57min,平均(32±6)min,开放升主动脉后50例心脏自动复跳,12例50-70瓦秒体外除颤复跳,术后呼吸机辅助呼吸时间为0-19h,平均(2.7±1.4)h,监护室滞留时间4-28h,平均(12±3.5)h,平均4.6(4~6)天出院,手术后并发症发生率为3.23%,手术后引流量30-260ml(66±21ml),有36例(19.35%)患者输血。本组没有手术中扩大切口改为非机器人全胸腔镜辅助下完成操作。手术中食道超声心动图证实本组病例没有残余漏发生,手术后随访3~8个月,心脏超声心动图复查未发现有残余漏等并发症,恢复良好。结论及意义对于膜部室间隔缺损小儿或成人患者采用全胸腔镜心脏手术技术修补是可行的、安全的,非机器人辅助下全胸腔镜二尖瓣置换术治疗二尖瓣病变具有可行性、安全性,与常规直视手术相比可以降低住监护室的时间和住院时间,获得了较好的微创和美容。总之,本课题科学验证了胸腔镜技术应用于室间隔缺损修补术、二尖瓣置换术的可行性、安全性,获得了较好的微创和美容,为胸腔镜技术在心脏外科的应用推广奠定了理论和临床基础,具有重要的科学意义。
【Abstract】 ObjectivesWe sought to investigate the feasibility and safety of totally thoracoscopic repair of a ventricular septal defect and to investigate the feasibility and safety of totally thoracoscopic replacement of mitral valve through three ports in right chest. To verify mode thoracoscopic cardiac surgery and surgical reliability, clinical treatment norms for thoracoscopic techniques to lay the theoretical foundation in the cardiac surgery and clinical application promotion.MethodsPatient selectionThis study was approved by the institutional review board of Qilu Hospital and Liaocheng People’s Hospital. Written informed consent was obtained from all participants before the study.Part I Written informed consent was obtained from all participants before the study. Between Sept2011and March2013, patients with congenital VSD were selected from the Department of Cardiac Surgery of the two hospitals. The selection criteria were:a) VSD of any size; b)>2years old with a body weight of more than15kg; c) pulmonary arterial systolic pressure (measured by echocardiography)<60mmHg; d) no previous history of lung disease or surgeries on the right chest; and4) no other cardiovascular disease or chronic illnesses. Of the selected119patients, there were66male and53females with a mean age of7.1±3.6years (range,2-36). The mean body weight was32.4±7.8kg (range,18-68). Echocardiographic examination showed membranous VSD in64, paramembranous VSD in55. The size of the defect ranged from4mm to14mm. Twenty-eight patients had mild pulmonary hypertension (pulmonary arterial pressure30-40mmHg),22patients had moderate pulmonary hypertension (pulmonary arterial pressure,40-59mm Hg), and6had severe pulmonary hypertension (pulmonary arterial pressure,60-90mm Hg). Sixteen patients also had tricuspid regurgitation due to right ventricular dilation. Valvuloplasty using DeVega technique and Edware ring were performed in nine and three patients, respectively, after the VSD repair in the same procedure. Follow-up echocardiographic studies showed no tricuspid regurgitation in these patients.Part II Written informed consent was obtained from all participants before the study. Between Oct2011and March2013,62patients with rheumatic heart disease were selected from the Department of Cardiac Surgery of the two hospitals. The selection criteria was:a) New York Heart Association functional class Ⅰ/Ⅱ; b) Age>15years old with a body weight of more than45kg; c) no left atrial thrombosis; d) Pulmonary arterial systolic pressure (measured by echocardiography)<60mmHg; e) no previous history of lung disease or surgeries on the right chest; and f) No other cardiovascular disease or chronic illnesses. Of the selected62patients, there were27males and35females with a mean age of51.7±5.6years (range,28-65). The mean body weight was66.4±6.7kg (range,48-90). Echocardiographic examination showed mitral valve stenosis in39, mitral valve regurgitation in10and combined mitral valve stenosis and regurgitation in13. Twenty-eight patients had mild pulmonary hypertension (pulmonary arterial pressure30-40mmHg), and13had moderate pulmonary hypertension (pulmonary arterial pressure,40-59mm Hg).AnesthesiaAfter induction of general anesthesia, a left-sided double-lumen endotracheal tube (>50kg) or single-lumen endotracheal tube(<50kg) was placed to allow for single-lung ventilation. The respiration rate was set between18-30/min and the arterial oxygen saturation rate was maintained at>97%. After the induction of general anesthesia, a transesophageal echocardiography probe was inserted to monitor the VSD closure. Cardiopulmonary bypass was established peripherally through femoral vein and femoral arteries.Surgical techniquesThe patient was positioned in a15-20degree left lateral decubitus position. Three small incisions (ports) were made on the right side of the chest. Port1(1-1.5cm) was located in the3th intercostal space inside of right midclavicular line. This port was for the insertion of surgical instruments such as tissue forceps, using the left hand (for a right-handed operator). Port2(1-1.5cm) was for the entry of instruments, such as scissors, suture needle, handled by the right hand of the operator. It was located in the5th or6th intercostal space outside right midclavicular line. Port3(1.5-2.0cm) was located in the4th intercostal space between mid-axilliary line and anterior axillary line. This port was for the placement of thoracoscopy.Once the ports were made, a tissues retractor was inserted into each of the three ports to keep the ports open and to facilitate the insertion or withdrawal of the instruments or thoracoscopy. First, a thoracoscopy was inserted through port3to visualize the right mediastinum.Pericardiotomy was performed and one suture was placed to suspend the pericardium. Caval snares were placed in the superior and inferior vena cava before commencing cardiopulmonary bypass. A3mm incision was made between left-superior pulmonary vein and the left atrium for the insertion of a left atrium drainage tube. The thoracoscopy was then removed from port one and repositioned through port2to visualize the root of the aorta. An aortic crossclamp was positioned on the ascending aorta, and a perfusion needle was inserted through port3to the aortic root for the delivery of cold St Thomas cardioplegic solution to achieve cardiac arrest.Part I The thoracoscopy was then repositioned through port3to visualize the right atrium. A tissue forceps and a scissors were entered through port1and port2, respectively. After the right atrium was opened from a site parallel to the atrioventricular annulus, three stay sutures were placed on the incision to expose the intra-atrial structure. The tricuspid valves were pulled apart and one stay suture was placed on the interventricular septum to expose VSD. For a defect of<6mm, direct suture (5-0or4-0Prolene) was used for closure. A bovine patch (Bairen Med Pharma Co, Beijing, China) was used to repair defects>6mm, using running Prolene sutures. DeVega technique or artificial tricuspid valves ring was used to repair tricuspid valve regurgitation.Part II The thoracoscopy was then repositioned through port3to visualize the right atrium. A tissue forceps and a scissors were entered through port1and port2, respectively. After the right atrium was opened from a site parallel to the atrioventricular annulus and atrial septal was opened in longitudinal axis of fossa ovalis, three stay sutures were placed on the incision to expose the left atrial structure and mitral valve. The mitral valves were ablated and Prosthesis was placed on home position, using interrupted sutures.After VSD or MVR closure, the right atrium was closed, and the air was exhaust from left heart. The aortic crossclamp was released, and the patient was rewarmed. Integrity of the VSD closure was confirmed by transesophageal echocardiography, and protamine sulfate (1:1) was administered to reverse the actions of heparin. After adequate hemostasis was achieved, all instruments were removed from the chest, and an18-24F chest tube was inserted in the right pleural space through port2for drainage. Finally, the cannulas in the right femoral vein and artery were removed, and incisions on the blood vessels were closed with sutures.In order to compare operational data and requirement for post-operative analgesics between conventional and thoracoscopic VSD closure,35patients undergoing open-chest surgery for VSD closure between June2009and March2012were selected. These patients were matched in the VSD types with the last35patients in the thoracoscopic group.Perioperative managementPrior to the surgery, education and counselling were provided to all participants on surgical techniques, possible clinical outcomes, potential complications and postoperative self-care measures. Lung function test was routinely performed in all patients before the surgery. The lungs were inflated every20min during the operation. Femoral artery and vein were assessed by colour Doppler ultrasound. Bedside chest X-ray was routinely performed in the intensive care unit to exclude complications in the lungs. Mechanical ventilation was ceased once patient’s hemodynamics was stabilized in operation room or in the intensive care unit.Statistical analysisSPSS v13.0was used for the statistical analysis. Quantitative variables are expressed as mean±SD. P value<0.05was considered statistically significant.Results Part I One patient had bleeding due to the injury to the inferior vena cava and the right atrium. Another patient had bleeding from the ascending aortic where a needle was inserted to perfuse cardioplegic solution. In both cases, the chest incision at port2was extended to4-5cm for better visualization of the bleeding sites, which were successfully stopped with sutures. Thoracoscopic VSD repair was successfully completed after the bleeding from the inferior vena cava or ascending aorta was stopped. Valvuloplasty using DeVega technique and Edware ring were performed in nine and three patients, respectively, after the VSD repair in the same procedure. Follow-up echocardiographic studies showed no tricuspid regurgitation in these patients.All patients survived the operation and being discharged from the hospital in4-6days. No patient in this cohort underwent reoperation for bleeding following the VSD repair. The mean CPB time was42.2±9.8min (range,34-142). The mean aortic crossclamp time was32.5±7.3min (range,25-57). Once the aortic clamp was removed, heart beat resumed spontaneously in84patients. In33patients,50W DC shock through the chest wall was performed to cardiovert the fibrillating heart back to sinus rhythm. The mean mechanical ventilation time was0.3±0.4h (range,0-19) and the mean duration of intensive care stay was11.0±2.6h (range,4-28). There was statistically significant difference in the mean mechanical ventilation time (0.3±0.4vs4.9±3.2h,P<.05) and duration of intensive care stay (11.0±2.6vs22.9±4.7h P<.05) between the six patients with severe pre-operative pulmonary hypertension and those with mild or moderate pre-operative pulmonary hypertension.In all patients, transesophageal echocardiography immediately after the VSD repair showed complete closure with no residual shunt. Three patients (2.26%) experienced arrhythmia, one had high degree atrioventricular conduction block which spontaneously recovered within24h following the operation. One had third degree atrioventricular conduction block which had not spontaneously recovery within seven days following the operation and was fitted with a permanence pacemaker. The other patient suffered atrial fibrillation following the VSD repair, but sinus rhythm returned after52h. One (0.75%) suffered from residence shunt which the size1mm and it closed itself in one month after the operation. One (0.75%) suffered from right pulmonary atelectasis which was recovered in two days following chest physiology therapy.Twenty-one patients (16%) required blood transfusion of400ml each during the procedure. The total volume of the post-operative chest drain ranged from30to460ml (mean,55±12ml). Patients have been followed up for6.8±3.9months (3-12months), with no signs of residual shunt on transthoracic echocardiography. Patients resumed work or schooling between14and23days (median,16) following the surgery.There was no significant difference in age, sex, cardiopulmonary bypass time and aortic crossclamp time between thoracoscopic and control group (P>.05). In the thoracoscopic group, total operation time, mechanical ventilation time, the blood loss during the surgery was significantly less than in the control group (P<.01), and the intensive care or hospital stays were shorter (P<.05). In the thoracoscopic group,38(31.9%) patients required opioid analgesics. In the control group,26patients (74.2%, P <.01) were administered with opioid analgesics for1-2days following the surgery.Part Ⅱ None of the cases required extension of chest incision. In one patient insertion of right femoral artery catheter was unsuccessfully therefore left femoral artery access was used. Valvuloplasty using DeVega technique and Edware ring were performed in6and18patients, respectively, after the mitral valve replaced in the same procedure. In5patients mitral valve replacement procedure was performed through interatrial groove incision. Follow-up echocardiographic studies showed no tricuspid regurgitation in these patients.The mean CPB time was62.2±9.8min (range,44-145). The mean aortic crossclamp time was41.5±7.3min (range,39-77). Once the aortic clamp was removed, heart beat resumed spontaneously in50patients. In12patients,50W DC shock through the chest wall was performed to defibrillate the heart. The mean mechanical ventilation time was2.2±0.6hours (range,1-22) and the mean duration of intensive care stay was14.1±4.5hours (range,6-48). No patient in this cohort underwent reoperation for bleeding following the mitral valve replacement. All patients were discharged from the hospital6-7days following the procedure.In all patients, transesophageal echocardiography immediately after the mitral valve replacement showed normal position and function of the prosthesis with no periprosthesis leakage.Newly onset of atrial fibrillation was found in6patients after the operation. One patient suffered from right pulmonary atelectasis which was recovered in two days following chest physiology therapy. Eleven patients (17.7%) required blood transfusion of400-800ml each during the procedure. The total volume of the post-operative chest drain ranged from30to460ml (mean,65±14ml).Patients have been followed up for5.2±3.9months (3-12months), with no signs of perivalvular leakage on transthoracic echocardiography. Patients resumed work23days (median,18) following the surgery.There was no significant difference in age, sex, cardiopulmonary bypass time and aortic crossclamp time between thoracoscopic and control group (P>0.05). In the thoracoscopic group, total operation time, mechanical ventilation time, and the blood loss during the surgery was significantly less than in the control group (P<0.01). The duration of intensive care or hospital stays in the thoracoscopic group were shorter than in the control group (P<0.05). In the thoracoscopic group,13(21.0%) patients required opioid analgesics postoperatively. In the control group,25patients (75.0%, P<0.01) were administered with opioid analgesics for1-2days following the surgery.Conclussions:Totally thoracoscopic repair of VSD through a3-port entry without the aid of a robotically-assisted surgical system appears to be safe and effective. Totally thoracoscopic mitral valve replacement without a robotically assisted surgical system appears feasible and safe.The patients had gotten a better minimally invasive and cosmetology,In summary, this study evaluated the scientific thoracoscopic techniques used in repair of ventricular septal defect, mitral valve replacement are feasibility and safety.They may be promote the application of thoracoscopic techniques in cardiac surgery laid the theoretical and clinical basis and has important scientific significance.