Impact of MitraClip Program on the Volume and Outcomes of Mitral Valve Surgery:A Single-Center Retrospective Study

Surgical repair has been the standard therapy for severe mitral regurgitation causing symptoms or left ventricular dysfunction.Percutaneous mitral valve repair has become an appealing alternative approach for patients who are not suitable for surgery.However,clinical trial data are not available on the institutional impact of a percutaneous mitral valve repair program on mitral valve surgery.The current study retrospectively evaluated the impact of the MitraClip program on the mitral valve surgery volume and outcomes.Patient data were retrieved from the 2 years before and the 2 years after initiation of the MitraClip program.The volume of MitraClip procedures increased from eight cases in 2015 to 91 cases in 2017.Since the initiation of the MitraClip program in 2015,the volume of both mitral valve replacement and mitral valve repair also increased(43 vs.60 and 110 vs.154,respectively).Importantly,we observed improved surgical outcomes,including fewer perioperative complications and lower operative mortality and in-hospital mortality.Data from our single-institution experience indicate that the introduction of the MitraClip program is associated with increased mitral valve surgery volume and improved outcomes.The establishment of the MitraClip program enables the hospital to provide higher quality of care and potentially become a referring center for structural heart patients.

Long-Term Outcomes Comparing Minimally Invasive Mitral Valve Repair versus Conventional Mitral Valve Surgery

Objectives: To compare the long term outcomes between minimally invasive mitral valve repair (MiMVR) and conventional surgery. Current retrospective comparisons between the techniques frequently report echocardiographical (echo) outcomes early after surgery and rarely report them later. Methods: Patients were selected for MiMVR by the surgical multi-disciplinary meeting from June 2008-March 2013. Patients included had at least two transthoracic post-operative echocardiograms. Echocardiographic parameters including left ventricular size and systolic function, degree of mitral regurgitation (MR) and mean mitral valve gradient were recorded. Clinical outcomes including all-cause mortality, re-operation, recurrence of at least moderate MR and elevated mean mitral valve gradients > 5 mmHg were recorded and compared using Kaplan-Meier survival analysis. Results: 223 patients were screened, 96 (43%) met the criteria and were included. Thirty-seven patients underwent conventional surgery and 59 underwent MiMVR. Mean clinical follow-up was 6.3 years and echo follow up was 3.2 years. There was a significantly higher recurrence of moderate MR in the conventional group (38% (n = 19) versus 17% (n = 10)). The mean LV end-diastolic diameter was 4.8 cm (conventional) versus 5.0 cm (MiMVR). The incidence of elevated PG was 26% (n = 13, conventional) and 23% (n = 14, MiMVR). There was no significant difference in incidence in re-operation (conventional 12% (n = 6), MiMVR 8.3% (n = 5)). Long-term mortality was higher in the conventional group (1.7% vs. 18% p = 0.004) although the logistic Euroscore was significantly higher 6.8% ± 5.4 vs. 3.6% ± 1.6. Conclusions: Minimally invasive mitral valve surgery is safe and feasible in selected patients with good medium and long-term echocardiographic follow-up.

The perioperative treatments of severe rhumatic heart disease with valve insufficiency

Objective To study the perioperative treatments for severe rheumatic heart disease with valve insuffciency. Methods Group 1 ( n = 25 ): mitral or/and arotic valve insufficiency, group 2 ( n = 17): valve stenosis and group 3 ( n = 14): simple congenital heart diseases. The load- independent index-end systolic elastance (Ees), pre-load recruited stroke work ( PRSW ), and the quantitive analyses of myocardial ultrastructure were observed and analyzed pre- and post-operatively. Results Ees was lower after operation than before operation in group 1, and it was a bit lower after operation in group 2. PRSW was significantly lower after operation than before operation in group 1, and it was similar before and after operation in group 2. The pre-load before operation and after-load after operation in group 1 increased. Vc%, Vvmyo% and Vvmit% were significantly lower in group 1 than in group 2. Ejection fraction (EF) was significantly lower after operation than before operation in group 1, and it was similar

Surgical management of moderate ischemic mitral valve regurgitation: Where do we stand?

Ischemic mitral regurgitation(IMR) represents a common complication after myocardial infarction. The valve is anatomically normal and the incompetence is the result of papillary muscles displacement and annular dilatation, causing leaflets tethering. Functionally the leaflets present a restricted systolic motion due to tethering forces that displaces the coaptation surface toward the left ventricle apex. The patients present poor left ventricular function at the time of surgery and the severity of the mitral regurgitation increases the risk of mortality. Currently there is general agreement to treat surgically severe IMR nevertheless strong evidences for patient with moderate insufficiency remains poor and proper treatment debated. The most effectivesurgical approach for the treatment of IMR remains debated. Some authors demonstrated that coronary artery bypass graft(CABG) alone is beneficial in patients with IMR. Conversely, in most patients, moderate IMR will persist or worsen after CABG alone which translate in higher long-term mortality as a function of residual mitral regurgitation severity. A probable reason for this unclear surgical management of functional MR is due to the contemporary suboptimal results of reparative techniques. The standard surgical treatment of chronic IMR is CABG associated with undersized annuloplasty using complete ring. Though, the recurrence of mitral regurgitation remains high(】 30%) because of continous left ventricle remodeling. To get better long term results, in the last decade, several subvalvular procedures in adjunct to mitral anuloplasty have been developed. Among them, surgical papillary muscle relocation represents the most appreciated option capable to restore normal left ventricle geometry. In the next future new preoperative predictors of increased mitral regurgitation recurrence are certainly needed to find an individual time period of treatment in each patient with moderate IMR.

Should mitral valve prolapse be considered as one of the risk factors for open angle glaucoma? A preliminary observation

AIM:To assess the incidence of mitral valve prolapse in patients with newly diagnosed primary open angle glaucoma.METHODS:The study included 12 patients without any other comorbidities or taking any general or local medications.Each patient underwent a full ophthalmological examination with visual field assessment and optical computed tomography of the macula and optic nerve head.Carotid Doppler ultrasound was performed to exclude impaired blood flow in this region and transthoracic echocardiography with assessment of the function and morphology of the heart valves.RESULTS:In the study group,mitral valve prolapse was found in seven patients(58.3%),while mitral valve regurgitation in 11 patients(91.7%).One case of normal pressure glaucoma and four cases of juvenile glaucoma were diagnosed.There were also other risk factors for glaucoma:myopia(58.3%),migraine headaches(41.7%),a positive family history of glaucoma(16.7%).CONCLUSION:Mitral valve prolapse could be indicated as a new risk factor for glaucoma.It seems reasonable to conduct screening tests for glaucoma in patients with mitral valve prolapse in the course of echocardiography.

Minimally Invasive Valve Surgery via Right Mini-Thoracotomy: Technical Aspects to Facilitate Prosthetic Valve Insertion

Mitral and tricuspid valve surgery is increasingly being performed through a right mini-thoracotomy approach. Although valve repair is preferred over replacement whenever possible, valve replacement may be required in certain patients. In situations where the mitral or tricuspid anatomy are unfavorable and exposure is difficult, seating a prosthetic valve in the annulus through a right mini-thoracotomy approach may be difficult, compared to conventional sternotomy approach. This is complicated by limited tactile feedback in the minimally invasive approach. Herein, we describe several simple maneuvers that facilitate proper prosthetic valve seating and visualization of the posterior annulus during minimally invasive valve operations via right mini-thoracotomy.

Catheter Ablation of Mitral Isthmus Flutter Post Mitral Valve Repair and Surgical Maze: Case Report and Review of the Literature

Hereby we describe a case of LAF developed after a surgical Maze procedure that demonstrates the importance of a systematic approach to mapping and ablating atypical atrial flutter to prevent a recurrence of symptomatic arrhythmia. In patients with previous cardiac surgery procedures, and in particular after a surgical maze, there are many different potential LA reentry circuits that involve various pathways. Both activation mapping and entrainment mapping were performed in order to identify the critical isthmus of the circuit and to effectively terminate the arrhythmia.

Midterm Results of Leaflet Augmentation in Mitral Valve Repairin Rheumatic Valves Experience in One Center

Patients with severe mitral regurgitation (MR) should undergo surgery when they present symptoms or if asymptomatic when there is objective evidence of left ventricular dysfunction. In this work, we analyze the midterm results of leaflet augmentation in mitral valve repair of rheumatic valves with gluteraldehyde preserved autologous pericardium. Patients and Methods: In our department 48 patients were exposed to mitral valve repair by leaflet augmentation either anterior or posterior beside other technique and all patients supported by flexible annuloplasty ring and followed for five years clinically and by echocardiography. Results: Age of the patients ranging from 12 to 47 years, mean age 25.9 ± 8.9 and there were 12 males (25%) and 36 females (75%) with male to female ratio of 1:3. All patients presented with shortness of breath (100%);with 14 patients were in NYHA class III (29.17%) and 34 patients were in NYHA class IV (70.83%). During follow-up period 5 patients needed reoperation by valve replacement, causes of reoperation were restrictive valve motion in one patient, left atrial thrombus in 1 patient and sever mitral regurgitation in 3 patients. Freedom from reoperation was 87.5%. At 5 years, (92.9%) were in New York Heart Association functional class I, three patients (7.1%) were in class II. Echocardiography at follow-up showed satisfactory mitral valve function. Conclusion: leaflet augmentation is a simple and reproducible method of valve repair for rheumatic MR with good midterm result.

First-in-human Results of the Novel Transcatheter Mitral Valve Repair System for Severe Mitral Regurgitation

Objective:To evaluate the feasibility,safety,and effectiveness of a novel edge-to-edge mitral valve repair system(the NovoClasp system)in patients with severe mitral regurgitation.Methods:In this prospective,single-arm,first-in-human study conducted at Beijing Anzhen Hospital,data were collected from patients undergoing transcatheter edge-to-edge repair using the NovoClasp system.The study candidates were patients exhibiting a mitral regurgitation severity of 3+or more and were at high-risk or contraindicated for surgical intervention.Technical success and device success according to the Mitral Valve Academic Research Consortium definitions were used as primary outcomes.Other safety and efficacy outcomes were prospectively assessed at device implantation,discharge,and 30 d,6 months,and 12 months post-procedure.Results:Between October 1,2021,and January 31,2022,11 patients were treated for moderate-to-severe(grade 3+)or severe(grade 4+)mitral regurgitation using the NovoClasp system.All patients had a baseline New York Heart Association functional class oflll-lIV,with 7/11 exhibiting complex mitral valve disease.All patients achieved the primary endpoints of technical and device success,with a post-operative 30-d mitral regurgitation grade reduction to 2+or lower,which was maintained at 12 months.One patient had minor bleeding and hematoma at the access site before discharge,and 2 patients were readmitted due to fast atrial fibrillation within 12 months post-discharge.No additional cases of death,adverse cerebral or cardiovascular events,or device-related complications was observed during the follow-up.Conclusion:This study suggested the potential feasibility and safety of the NovoClasp system,showing a promising technical and device success rate,along with a decrease in mitral regurgitation severity.A further pivotal study is needed to assess the procedural and long-term outcomes.

保留二尖瓣瓣下结构二尖瓣膜置换手术对心功能、瓣膜功能的影响及并发症

目的探讨保留二尖瓣瓣下结构二尖瓣膜置换手术对心功能、瓣膜功能及并发症的影响。方法选取2019年8月至2022年7月在苏州大学附属第一医院行保留二尖瓣瓣下结构二尖瓣膜置换手术患者84例作为观察组,同时选取同期未保留二尖瓣瓣下结构二尖瓣膜置换手术患者68例作为对照组,比较两组手术指标和并发症,以及手术前后心功能指标、二尖瓣口血流动力学参数。结果观察组和对照组手术时间、体外循环时间、主动脉阻断时间、术后机械通气时间、ICU滞留时间和术后住院时间比较差异无统计学意义(P>0.05);观察组术后1、3和6个月时左室收缩末期内径(LVESD)、左室舒张末期内径(LVEDD)明显低于对照组(P<0.05),左室短轴缩短率(LVFS)明显高于对照组(P<0.05);观察组和对照组术后1、3和6个月时左室射血分数(LVEF)比较差异无统计学意义(P>0.05);观察组和对照组术后1、3和6个月时二尖瓣口峰值流速(Vmax)、最大跨瓣压差(PGmax)和平均跨瓣压差(PGmean)比较差异无统计学意义(P>0.05);观察组和对照组术后1、3和6个月时肌酸激酶同工酶(CK-MB)和N末端前体脑利钠肽(NT-proBNP)比较差异无统计学意义(P>0.05);观察组和对照组术后并发症发生率比较差异无统计学意义(P>0.05)。结论保留二尖瓣瓣下结构二尖瓣膜置换手术有助于心脏结构保护、改善患者心功能,同时与不保留二尖瓣瓣下结构手术相比,二尖瓣口血流参数及并发症无明显差异。

人工腱索在二尖瓣关闭不全后叶成形术中的应用及近中期疗效

目的了解人工腱索在二尖瓣关闭不全后叶病变中应用的可行性及近中期临床效果。方法选取在河北医科大学第二医院心脏外科,诊断二尖瓣脱垂伴关闭不全接受二尖瓣成形治疗的患者99例,其中单纯前叶脱垂41例,单纯后叶脱垂44例,前后叶均脱垂4例,交界脱垂10例。针对48例存在后叶脱垂的患者采用人工腱索的方法纠正二尖瓣后叶关闭不全。结果接受应用人工腱索纠正瓣膜后叶关闭不全的48例患者,随访13~81个月,平均(40.60±15.57)个月,术后1年因二尖瓣病变再次接受手术者0例,术后2年接受再次手术者共2例,术后5年接受再次手术者共2例,占全部后叶成型患者的4.2%。术后患者左心室射血分数、左心室舒张末径、二尖瓣血液返流面积以及心脏功能均较术前明显改善,差异有统计学意义(P<0.05)。随访数据显示术后6个月~1年这些指标改善更加明显。二尖瓣血液返流面积,随时间的延长,有逐渐增加的趋势,但目前资料尚未显示差异有统计学意义(P<0.05)。术后二尖瓣口血液流速、左心室流出道血液流速,以及二尖瓣瓣口面积均在正常值范围,未出现二尖瓣口狭窄。结论应用人工腱索治疗二尖瓣后叶脱垂是有效的,临床可以取得可靠的疗效。

复脉益心方辅助治疗风湿性心脏瓣膜病患者的临床疗效及对其心功能、基质金属蛋白酶-9、N末端前体脑利钠肽水平的影响

目的 探讨复脉益心方辅助治疗风湿性心脏瓣膜病患者的疗效及对其心功能、血清基质金属蛋白酶-9(Matrix metalloprotein-9,MMP-9)水平、N末端前体脑利钠肽(N-terminal precursor brain natriuretic peptide,NT-pro BNP)水平的影响。方法 选取2021年2月—2022年2月期间湖南中医药大学第一附属医院收治的风湿性心脏瓣膜病患者88例作为研究对象。采用随机数字表法将患者分为对照组和观察组,每组各44例。两组患者均接受二尖瓣置换术治疗,术后根据病情给予西医常规治疗,观察组术后在常规西医治疗基础上联合复脉益心方治疗。治疗4周后,观察比较两组患者临床疗效、安全性,治疗前后中医证候积分,MMP-9、NT-pro BNP水平、心功能指标(每分钟心输出量、每搏输出量、心脏指数、左心室射血分数)、生活质量评分(社会限制、体力限制、症状、情绪)变化情况。结果 治疗后两组患者心悸、疲乏、气短、盗汗或自汗、心烦、失眠多梦评分均较治疗前降低,差异有统计学意义(P<0.05);且观察组心悸、疲乏、气短、盗汗或自汗、心烦、失眠多梦评分均明显低于对照组,差异有统计学意义(P<0.05)。治疗后两组患者血清MMP-9和NT-pro BNP水平均较治疗前明显降低,差异有统计学意义(P<0.05);且观察组血清MMP-9和NT-pro BNP水平均明显低于对照组,差异有统计学意义(P<0.05)。治疗后两组患者每分钟心输出量、每搏输出量、心脏指数及左心室射血分数指标均较治疗前明显升高,差异有统计学意义(P<0.05);且观察组每分钟心输出量、每搏输出量、心脏指数及左心室射血分数指标均高于对照组,差异有统计学意义(P<0.05)。治疗后两组患者社会限制、体力限制、症状及情绪评分均较治疗前明显降低,差异有统计学意义(P<0.05);且观察组社会限制、体力限制、症状及情绪评分均低于对照组,差异有统计学意义(P<0.05)。治疗后观察组总有效率95.45%(42/44)明显高于对照组79.55%(35/44),差异有统计学意义(P<0.05)。治疗期间,两组患者肝肾功能、血常规均未发生异常,术后也未出现明显用药不良反应。结论 复脉益心方辅助二尖瓣置换术治疗风湿性心脏瓣膜病,能够降低MMP-9、NT-proBNP水平,有助于改善患者心功能,保护心肌,快速缓解患者临床症状,提高生活质量。

达芬奇机器人辅助与常规开胸二尖瓣手术患者术后早期效果的对比观察

目的 观察比较达芬奇机器人辅助二尖瓣手术与常规开胸二尖瓣手术患者的短期预后。方法 单中心回顾性临床观察研究。收集2022年4月至2023年4月在青岛大学附属医院行二尖瓣置换或成形手术的174例患者资料,男性81例、女性93例,年龄35~70岁、平均年龄57.9岁,依据手术方式分为达芬奇机器人辅助手术组(达芬奇组,84例)和常规开胸手术组(常规组,90例),比较两组的体外循环时间、主动脉阻断时间和输血量等术中资料,以及术后呼吸机辅助通气时间、重症监护室滞留时间、住院时间、引流量、再次手术、30d内死亡、血常规、C反应蛋白、凝血指标、心肌肌钙蛋白I(cTnI)、血清B型利钠肽(BNP)和肝肾功能等短期预后指标。结果 两组患者术前基线临床资料比较,差异均无统计学意义(均为P>0.05)。两组患者均无术后再次手术及术后30d内死亡情况。与常规组相比,达芬奇组体外循环时间和主动脉阻断时间较长(t=9.420和8.015,均为P<0.001),术中自体血回输量及异体血浆使用量较少(Z=-3.611和-3.332,均为P<0.01),术后呼吸机辅助通气时间、重症监护室滞留时间、住院时间、术后24、48和72h内引流量较少(Z=-5.868、-5.243、-2.989、-7.886、-5.314和-3.222,均为P<0.01),术毕心肌损伤标志物cTnI和BNP水平较低(Z=-5.220和-4.388,均为P<0.001),术毕及术后第1天血小板计数、术毕纤维蛋白原浓度较高(Z=-3.304、-2.521和-3.064,均为P<0.01)。达芬奇组术后3d内肝功能异常发生率较高,差异有统计学意义(χ~2=8.518,P=0.004);但两组术后第5天肝功能异常发生率无统计学差异(χ~2=1.171,P=0.279)。与常规组相比,达芬奇组术后第1和2天的尿素氮水平较低(Z=-3.057和-3.793,均为P<0.01),术后第2天的肌酐水平较低(Z=-2.545,P=0.011)。两组术后C反应蛋白水平比较,差异均无统计学意义(均为P>0.05)。结论 尽管观察到达芬奇机器人辅助较常规开胸二尖瓣手术的体外循环时间及主动脉阻断时间延长,对术后肝功能有一过性影响,但对术后凝血功能、心肌和肾功能损伤较小,可缩短住院时间,患者短期预后较好。

三维斑点追踪成像技术评估心房功能性二尖瓣反流患者左心室功能

目的:应用三维斑点追踪成像技术(3D-STI)探讨心房功能性二尖瓣反流(AFMR)患者的左心室功能,并探讨其临床应用价值。方法:选取82例心房颤动患者,根据其有无AFMR分为单纯房颤组48例和心房AFMR组34例,另选取同时期40例健康志愿者作为对照组。应用3D-STI获取心肌整体纵向应变(GLS)、整体圆周应变(GCS)、整体径向应变(GRS)和左心室整体扭转角度峰值(LVP_(tw)),比较上述参数在各组之间的差异。绘制3D-STI各参数评价AFMR隐匿性左心室功能受损的ROC曲线,确定GLS、GCS、GRS及LVP_(tw)对AFMR患者左心室功能受损的诊断效能。结果:与对照组相比,单纯房颤组GLS、GCS、GRS均降低,差异均具有统计学意义(P均<0.05);与对照组、单纯房颤组比较,AFMR组GLS、GCS、GRS、LVP_(tw)均降低,差异均具有统计学意义(P均<0.05)。ROC曲线分析显示,GLS、GCS、GRS和LVP_(tw)诊断AFMR患者左心室功能受损的曲线下面积分别为0.884、0.788、0.865及0.850。结论:应用3D-STI可检测AFMR患者早期左心室心肌受损的情况,根据其心肌应变及心肌扭转参数,对指导临床进行早期干预具有一定的价值。

缺血性心肌病发生缺血性二尖瓣反流的危险因素

目的观察缺血性心肌病发生缺血性二尖瓣反流(IMR)的危险因素。方法回顾性选择143例缺血性心肌病患者,根据有无IMR将其分为IMR+组(n=68)及IMR-组(n=75);另以50名健康志愿者为对照组;比较组间一般资料、左心室常规超声参数、三维斑点追踪成像(3D-STI)参数及二尖瓣结构功能参数,以logistic回归分析筛选发生IMR的危险因素。结果IMR+组与IMR-组左心室舒张末期容积(LVEDV)、左心室收缩末期容积(LVESV)、左心室整体纵向应变(GLS)、整体扭转角度峰值(Twist)、帐篷容积(VTent)及小叶总面积(TLA)/瓣环面积(AA)差异均有统计学意义(P均<0.05);GLS减小、Twist降低及VTent增大均为缺血性心肌病发生IMR的独立危险因素(P均<0.05)。结论GLS减小、Twist降低及VTent增大为缺血性心肌病发生IMR的危险因素。

左心瓣膜术后单纯性三尖瓣关闭不全的微创治疗方案及围术期结果

目的分析全胸腔镜手术治疗左心瓣膜术后单纯性重度三尖瓣关闭不全的围术期结果,探讨全胸腔镜手术在再次三尖瓣手术中的优势及临床效果。方法回顾性收集2018年1月至2023年12月在解放军总医院第一医学中心心脏大血管外科接受全胸腔镜三尖瓣手术治疗的左心瓣膜术后单纯性重度三尖瓣关闭不全患者的临床资料。共计134例患者符合标准纳入研究,总结其围术期临床资料以及治疗经验。其中72例(53.7%)患者行三尖瓣成形术(三尖瓣成形组),62例(46.3%)患者行三尖瓣置换术(三尖瓣置换组),比较两组相关指标。结果134例患者体外循环中位时间为92 min,平均手术时间为(183.8±56.1)min。2例(1.5%)患者体外循环撤机后出现右心功能不全,后予以体外膜肺氧合支持,于术后1周内顺利撤机。术中输注血制品54例(40.3%)。术后患者呼吸机辅助通气中位时间为13.0 h。重症监护室(ICU)停留中位时间为2.0 d,引流管拔除中位时间为2.0 d,术后胸腔引流量中位数为475.0 mL。16例患者出现术后早期并发症,包括室颤2例,胸腔积液4例,住院再手术2例,起搏器植入8例。无术后早期死亡。三尖瓣成形组肺动脉压、术前房颤占比低于三尖瓣置换组,差异有统计学意义(P<0.05)。三尖瓣成形组手术时间、术后机械通气时间、ICU停留时间短于三尖瓣置换组,术中输血浆量、术后引流量、术后右心房内径、术后右心室舒张末期内径、左心房内径、术后并发症发生率低于三尖瓣置换组,差异有统计学意义(P<0.05)。两组患者体外循环时间、术中输血率、引流管拔除时间、术后左心室舒张末期内径、术后左心室射血分数、术后次日肌钙蛋白T、术后次日肌酸激酶同工酶MB、人工心脏辅助装置(包括体外膜肺氧合和主动脉内球囊反搏)使用率等差异无统计学意义(P>0.05)。结论全胸腔镜体外循环下不停跳三尖瓣手术具有手术创伤小、术后恢复快等优点。对于满足手术指征的患者,尽早手术可能有更高概率接受三尖瓣成形术和获得更好的围术期结果。

二尖瓣手术联合三尖瓣修复治疗老年退行性二尖瓣关闭不全并发三尖瓣轻中度反流及环形扩张的临床研究

目的:探讨老年退行性二尖瓣关闭不全合并三尖瓣轻度、中度反流伴环形扩张病人采用二尖瓣置换(MVR)同期三尖瓣成形术(TVP)治疗的效果。方法:对我院2016年1月—2021年1月实施手术治疗的95例老年退行性二尖瓣关闭不全合并三尖瓣轻度、中度反流伴环形扩张病人进行回顾性分析。仅采取MVR治疗的47例病人作为对照组,MVR同期TVP实施手术的48例病人作为研究组,比较两组病人手术过程及术后恢复指标、手术前后超声心动图指标、三尖瓣反流程度分级、并发症发生率。结果:研究组手术时间、主动脉阻断时间、体外循环时间均明显长于对照组,差异均有统计学意义(P<0.05);两组重症监护室(ICU)停留时间、心包纵隔引流量、呼吸机使用时间比较,差异均无统计学意义(P>0.05)。术后24个月,两组右心房内径(RVEDD)、右心室舒张末期内径(RV)、三尖瓣舒张期瓣环径(DTV)、动脉高压(SPAP)测定值均较术前明显降低(P<0.05),两组左室短轴缩短率(LVFS)较术前均明显提高(P<0.05);研究组RA、RVEDD、DTV、SPAP明显低于对照组,LVFS明显高于对照组,差异均有统计学意义(P<0.05)。术后24个月,研究组无反流23例、轻度反流25例,对照组无反流4例、轻度反流14例、中度反流29例,研究组术后的三尖瓣反流病情明显减轻(P<0.05)。两组手术后并发症发生率比较差异无统计学意义(P>0.05)。结论:老年退行性二尖瓣关闭不全合并三尖瓣轻度、中度反流伴环形扩张病人采用MVR同期TVP治疗较单纯的MVR治疗临床效果更好,且不会增加手术并发症发生率。

经导管二尖瓣夹系统临床评价审评概述及审评关注点

经导管二尖瓣夹系统是基于外科二尖瓣缘对缘修复技术,使用可植入二尖瓣夹通过经皮介入手术紧密对接二尖瓣瓣叶,在整个心动周期中使二尖瓣瓣叶紧密对接,达到治疗二尖瓣反流(MR)的效果。目前国内外监管机构已批准多个经导管二尖瓣夹系统评价上市,我国也有十余款经导管二尖瓣夹系统处于上市前临床研究阶段。分析美国食品药品管理局(FDA)对经导管二尖瓣夹系统MitraClip System和Pascal Precision的临床试验和审评关注点,并阐述国产首个上市的二尖瓣夹系统的临床试验,总结该类产品临床评价过程中的审评关注点,以期为该类产品的临床评价和技术审评提供思路。

单操作孔全胸腔镜与传统开胸二尖瓣置换术的效果比较

目的:比较单操作孔全胸腔镜与传统开胸二尖瓣置换手术的效果。方法:选取2021年4月至2023年2月收治的二尖瓣病变患者97例,按手术方式分为胸腔镜组51例与开胸组46例,比较2组术中创伤及术后恢复情况、围术期甲状旁腺素(PTH)、心肌肌钙蛋白T(cTnT)水平及并发症情况。结果:腔镜组手术时长、体外循环时间、主动脉阻断时间长于开胸组,使用悬浮红细胞及血浆、切口范围小于开胸组(P<0.05);腔镜组使用呼吸机时间、重症监护病房(ICU)停留时间、引流管拔除时间、住院时间短于开胸组,引流量、术后第1 d疼痛视觉模拟评分低于开胸组(P<0.05),2组术后心脏结构与功能指标差异无统计学意义;胸腔镜组体外循环停机即刻PTH、cTnT高于开胸组,2组术后24、48 h上述指标差异无统计学意义;胸腔镜组术后并发症发生率9.80%低于开胸组28.26%,(P<0.05)。结论:单操作孔全胸腔镜二尖瓣置换术创伤小,恢复快,并发症少,疗效确切,安全性与实用性较高。

Live three-dimensional transesophageal echocardiography in mitral valve surgery

Background Live three-dimensional transesophageal echocardiography （live-3D-TEE） is a new technique, but its clinical value is unclear at present. This study aimed to investigate the feasibility, imaging quality and accuracy of live-3D-TEE for assessing mitral valve morphology to determine if live-3D-TEE has important value in mitral valve surgery.Methods Twenty-four patients with mitral valve disease （mean age （47.1±11.6） years, mean weight （64.7±10.5） kg） underwent live-3D-TEE and two dimensional transesophageal echocardiography （2D-TEE） before and after mitral valve surgery. Sensitivity, specificity, and total consistency rates of live-3D-TEE for diagnosing ruptured chordae were calculated and compared to surgeon＇s findings. We also compared the diagnostic accuracy of mitral valve disease between live-3D-TEE and 2D-TEE.Results Live-3D-TEE allowed visualization of the anatomic structure of the heart online and clearly identified the valvular apparatus and their defects. Sensitivity and specificity for the detection of ruptured chordae by live-3D-TEE were 87.5% and 100% respectively, and the total consistency rate was 95.8%. Additional defects not diagnosted by 2D-TEE were found in three cases （12.5%） preoperatively by live-3D-TEE. Live-3D-TEE could evaluate the function of prosthetic or native valves immediately after operation. One case was re-repaired （4.2%） using guidance by live-3D-TEE.Conclusion Live-3D-TEE enabled evaluation of mitral valve function and provided adequate valuable information before and after mitral valve surgery. We conclude that live-3D-TEE can play an important role in mitral valve surgery.