国产CL-V型双叶人工心脏瓣膜与进口St.Jude双叶瓣的临床疗效比较

目的观察和评价国产CL-V型双叶瓣植入人体后的早期临床疗效和近期随访结果。方法自2004年4月至2010年5月对38例心脏瓣膜病变患者行人工心脏瓣膜置换术,其中使用国产CL-V型双叶瓣18例(CL组),男8例,女10例;年龄(47.4±6.2)岁;体重(64.7±11.9)kg;术前心功能分级(NYHA)Ⅲ级15例,Ⅳ级2例,行二尖瓣置换术16例,二尖瓣+主动脉瓣双瓣膜置换术(DVR)2例,共植入CL-V型双叶瓣20枚。使用进口St.Jude双叶瓣20例(SJM组),男9例,女11例;年龄(49.7±7.6)岁;体重(66.1±11.1)kg;术前心功能分级Ⅲ级15例,Ⅳ级3例;行二尖瓣置换术17例,主动脉瓣置换术1例,DVR2例;共植入St.Jude双叶瓣22枚。在相同条件下,比较分析两组患者术后7d,术后6个月的临床结果、心功能、血流动力学和血液相容性等指标。结果两组患者无早期死亡(30 d内),无术后早期并发症;随访率100%,平均随访时间19.8(6～61)个月。术后6个月心功能分级均从Ⅲ～Ⅳ级提高为Ⅰ～Ⅱ级,CL组心胸比率为0.51±0.05,左心房长径(44.5±7.8)mm,左心室舒张期末内径(46.6±4.1)mm,左心室射血分数(LVEF)65.3%±7.7%,左心室短轴缩短率(LVFS)35.0%±7.1%;SJM组心胸比率0.51±0.06,左心房长径(45.8±9.6)mm,左心室舒张期末内径(46.2±9.8)mm,LVEF 64.1%±9.0%,LVFS 34.9%±4.7%,组间比较差异均无统计学意义(P>0.05)。术后6个月经胸多普勒超声心动图检测同型号27 mm双叶瓣,平均跨瓣压差CL组(5.1±0.9)mm Hg,SJM组(5.8±0.8)mm Hg;有效瓣口面积CL组(2.3±0.3)cm2,SJM组(2.5±0.2)cm2,组间差异均无统计学意义(P>0.05)。对比术前和术后6个月两组患者的血红蛋白、乳酸脱氢酶、血小板计数组间差异均无统计学意义(P>0.05),均属正常范围,未发现溶血反应及溶血性贫血。采用相同的抗凝治疗强度下国际标准化比率(INR)1.5～2.5],两组患者术后早期及近期随访中均未发现血栓栓塞和严重的抗凝相关出血事件。结论国产CL-V型双叶瓣早期临床疗效和近期随访结果与St.Jude双叶瓣类似,其早期临床疗效明显,血流动力学稳定,血液相容性良好;近期随访中患者心功能改善,未发现与人工瓣膜有关并发症,对其中、远期疗效需做进一步随访观察。

Comparison on Clinical Outcomes Between China-made CL-V Bileaflet Prosthesis and St. Jude Bileaflet Prosthesis

Objective To evaluate early clinical outcomes and short-term follow-up results of CL-V bileaflet prosthesis.Methods From April 2004 to May 2010,38 patients with valvular heart diseases underwent mechanical heart valve replacement.Eighteen patients received CL-V bileaflet valve replacement(CL group)including 8 males and 10 females with their mean age of(47.4±6.2)years and mean body weight of(64.7±11.9)kg.Preoperatively,15 patients were in New York Heart Association(NYHA)classⅢ,and 2 patients were in NYHA class Ⅳ.Mitral valve replacement(MVR)was performed in 16 patients,mitral and aortic valve replacement(DVR)in 2 patients.A total of 20 CL-V bileaflet prostheses were implanted.Twenty patients received St.Jude bileaflet valve replacement(SJM group)including 9 males and 11 females with their mean age of(49.7±7.6)years and mean body weight of(66.1±11.1)kg.Preoperatively,15 patients were in NYHA class Ⅲ,and 3 patients were in NYHA class Ⅳ.MVR was performed in 17 patients,aortic valve replacement(AVR)in 1 patient,and DVR in 2 patients.A total of 22 St.Jude bileaflet prostheses were implanted.Clinical outcomes,hear function,hemodynamics and blood compatibility were measured on the 7th postoperative day and 6 months during follow-up and compared between the two groups.Results There was no early mortality(< 30 d)or postoperative complication in either group.Follow-up rate was 100% and the mean follow-up duration was 19.8(6-61) months.At 6 months after surgery,those patients who were preoperatively in NYHA classⅢ orⅣall improved to classⅠ orⅡ.In CL group,cardiothoracic ratio was 0.51±0.05,left atrium diameter(44.5±7.8)mm,left ventricular end diastolic diameter(LVEDD,46.6±4.1)mm,LVEF 65.3%±7.7%,and LVFS 35.0%±7.1%.In SJM group,cardiothoracic ratio was 0.51±0.06,left atrium diameter(45.8±9.6)mm,LVEDD(46.2±9.8)mm,LVEF 64.1%±9.0%,and LVFS 34.9%±4.7%,which were not statistically different from those parameters of CL group respectively(P > 0.05).At 6 months after surgery,transthoracic echocardiography was used to compare hemodynamics of bileaflet prostheses with same size 27 mm in the two groups.Prosthetic transvalvular gradient was(5.1±0.9)mm Hg in CL group and(5.8±0.8) mm Hg in SJM group,and effective orifice area was(2.3±0.3)cm 2 in CL group and(2.5±0.2)cm 2 in SJM group,which were not statistically significant between the two groups(P > 0.05)respectively.In both groups,the level of hemoglobin,lactate dehydrogenase and platelet at 6 months postoperatively were all within normal range and not statistically from those respective preoperative parameters(P > 0.05).Hemolytic reaction and hemolytic anemia were not found.During early and short-term follow-up,there was no thromboembolic complications or anticoagulation-related severe bleeding events in the two groups with same anticoagulation intensity target(target INR value 1.5 to 2.5).Conclusion Early clinical outcomes and short-term follow-up results of CL-V bileaflet prostheses are similar to those of St.Jude bileaflet prostheses.Postoperative patients have good clinical outcomes,hemodynamics and blood compatibility.Patients’ heart function significantly improve during short-term follow-up without valve-related complication.Mid-term and Long-term follow-up are further needed to demonstrate its good performance.