535例GK双叶机械瓣的临床应用分析

目的分析535例GK双叶机械瓣的使用情况,总结其临床经验。方法福建医科大学附属协和医院心脏外科2009年12月至2010年12月期间,对535例瓣膜病患者采用GK双叶机械瓣膜行心瓣膜置换术,其中男201例,女334例;年龄23～63岁（47．12±9．10岁）;风湿性心脏病402例,退行性病变102例,感染性心内膜炎18例,先天性主动脉瓣二叶式畸形13例。于术前和术后3个月用彩色多普勒超声心动图检测所有患者的左心室射血分数（LVEF）、主动脉瓣和二尖瓣平均跨瓣压差及有效瓣口面积的变化。结果本组手术死亡率为0．75％（4／535）,2例死于急性肾功能衰竭,2例死于心律失常。术后返院随访53l例,随访3个月,无I例发生心脏事件,术后心功能恢复至I级363例,Ⅱ级168例。心脏彩色超声心动图结果提示：患者术后LVEF较术前提高（67．76％±5．88％VS．56。00％±10．87％,t：3．197,P=0．001）,术后跨瓣压差较术前降低（24．27±5．45mmHgVS．54．25±30．59mmHa,t=3．216,P=0．001）。置换二尖瓣位和主动脉瓣位机械瓣的术后跨瓣压差低、有效瓣口面积大,血流动力学明显改善。结论GK双叶瓣在植入后由于其有效瓣口面积大、术后跨瓣压差低,能获得很好的近期临床疗效。     

19mm St.Jude Regent瓣有效瓣口面积和血流动力学的早期在体研究

目的 了解19mmSt．Jude Regent瓣的在体有效瓣口面积及植入后是否发生瓣膜一患者不匹配现象（PPM）。方法 23例心脏瓣膜病患者根据术中测量的主动脉瓣环径大小分为19mm Regent瓣组和21mm其它双叶机械瓣膜组，均常规行二尖瓣、主动脉瓣双瓣膜置换术；运用彩色多普勒超声心动图技术，于术前和术后3～6个月测量血流动力学指标，并计算左心室重量及有效瓣口面积等参数。结果 两组患者围术期及术后3～6个月内未发生心脏事件，术后3～6个月左心室重量均较术前减轻；两组患者的主动脉瓣有效瓣口面积、有效瓣口面积指数、左心室重量减轻程度差异无统计学意义（P〉0．05）。结论 （1）19mm St.Jude Regent瓣与21mm其它进口双叶机械瓣有相同的有效瓣口面积和血流动力学效果；（2）在二尖瓣、主动脉瓣双瓣膜置换术中，当主动脉瓣瓣环径偏小时应用19mm St．Jude Regent瓣是比较安全的，不会增加术后早期的心脏事件，不会发生术后早期的PPM；（3）对于PPM的标准，应进一步扩大病例数量、延长随访时间，进行深入研究；（4）St．Jude Regent瓣有临床应用价值，但需进一步随访观察。     

国产GK型双叶式人工心脏瓣膜的临床应用

目的观察和评价国产GK型双叶式人工心脏瓣膜(GK双叶瓣)植入人体后的早期临床疗效和近期随访结果。方法对61例心脏瓣膜病变患者行人工心脏瓣膜置换术,其中二尖瓣置换术(M VR)34例,主动脉瓣置换术(AVR)16例,二尖瓣和主动脉瓣双瓣膜置换术(M VR+AVR)11例。共植入GK双叶瓣72枚,其中二尖瓣45枚,主动脉瓣27枚;术后监测血液相容性和血流动力学指标,并定期随访和检查是否有与瓣膜相关的并发症发生。结果全组无手术死亡(术后30d内);随访61例,随访1年至2年6个月,远期因外伤死亡1例;其余60例患者术后心功能均从Ⅲ~Ⅳ级转为Ⅰ~Ⅱ级,血流动力学性能及生物相容性良好,生活质量改善。结论GK双叶瓣早期临床应用获得了满意的效果,其近期随访未发现与瓣膜相关的并发症,中、远期结果有待进一步随访观察。     

310例保留后瓣的二尖瓣人工瓣置换术的临床分析

目的总结保留二尖瓣后瓣及瓣下结构的二尖瓣置换术的临床效果。方法完成保留二尖瓣后瓣及瓣下结构的二尖瓣置换术310例,男112例,女188例,均为风湿性心脏病。术前心功能分级(NYHA)I级33例,II级119例,III级126例,IV级32例。结果术后死亡2例,随访6个月~6年,无死亡病例,心功能I-Ⅱ级。结论保留二尖瓣后瓣及瓣下结构二尖瓣置换术可减少左心室破裂的危险,改善术后心功能。     

慢性中重度缺血陛二尖瓣关闭不全的外科治疗及中期随访

目的 比较二尖瓣成形术和瓣膜置换术治疗慢性中重度缺血性二尖瓣关闭不全的手术效果及中期随访结果 .方法 自2002年6月至2008年5月,83例慢性缺血性二尖瓣关闭不全(中度35例,重度48例)接受冠状动脉旁路移植术同期行二尖瓣成形术或二尖瓣置换术.男49例,女34例;年龄51～77岁,平均(59.3±7.5)岁.43例二尖瓣成形术包括使用Dacron补片条或自体心包条环缩后瓣环21例,交界处环缩9例,后叶矩形切除9例,St.Jude成形环环缩4例.40例二尖瓣置换术包括机械瓣28例,生物瓣12例.结果 住院死亡3例,二尖瓣成形术组和二尖瓣置换术组住院死亡分别占2.3%(1/43例)、5.0%(2/40例),差异无统计学意义(P>0.05).术后瓣膜置换组机械通气时间长于二尖瓣成形组(P<0.05),二尖瓣成形组术后6例残余轻度二尖瓣反流(P<0.05)但不影响心功能,两组其他住院并发症无统计学差异(P>0.05).76例通过门诊或电话随访,随访3～60个月,平均(20.2±4.9)个月.随访期间二尖瓣成形术7例轻度二尖瓣反流.瓣膜置换组人工瓣功能均良好,3例出现抗凝相关并发症.随访远期死亡7例,冠状动脉旁路移植术同期二尖瓣成形术和二尖瓣置换术5年生存率分别为90%和61%.结论 对于慢性中重度缺血性二尖瓣关闭不全病人,二尖瓣成形术后近期和远期效果好,可作为优先选择的术式.     

胸腔镜下二尖瓣生物瓣置换术32例分析

目的探讨胸腔镜下二尖瓣生物瓣置换的经验,评价其临床效果。方法回顾性分析2013年3～12月在广东省人民医院心血管外科行胸腔镜下二尖瓣生物瓣置换术32例患者的临床资料。其中男14例、女18例,年龄19～80（55.6±17.3）岁,体重37～78（55.7±9.7）kg,体表面积1.30～1.95（1.67±0.16）m^2;合并心房颤动5例,术前心功能分级（NYHA）Ⅱ级20例,Ⅲ级11例,Ⅳ级1例;二尖瓣风湿性病变16例,二尖瓣退行性病变11例,感染性心内膜炎4例,合并先天性心脏病1例。结果所有患者均行胸腔镜下二尖瓣生物瓣置换术,其中采用Medtronic HancockⅡ人工生物瓣27例,Medtronic Mosaic生物瓣5例。同期行三尖瓣成形术13例,房间隔缺损修补术1例。全组患者住院期间无死亡,均顺利出院,住院期间未并发低心排血量综合征及左心室破裂。术后复查心脏彩色超声心动图提示,所有患者人工二尖瓣功能良好,无瓣周漏发生。术后患者心功能较术前明显改善,心功能恢复至Ⅰ级9例,Ⅱ级17例,Ⅲ级6例。术后早期及术后3个月左心房内径及左心室舒张期末内径与术前相比均明显减小。而术后早期及术后3个月左心室射血分数（LVEF）与术前相比有所降低。结论胸腔镜下二尖瓣生物瓣置换术创伤小,并发症少,安全可行,使用特殊类型生物瓣可明显减小手术切口大小。     

全保留二尖瓣及瓣下结构在重症二尖瓣关闭不全患者二尖瓣置换术中的应用

目的探讨全保留二尖瓣及瓣下结构在重症二尖瓣关闭不全患者二尖瓣置换术中的应用经验,评价其临床效果。方法回顾性分析2011年6月至2013年1月在广东省人民医院心血管外科因重症二尖瓣关闭不全行全保留二尖瓣及瓣下结构二尖瓣置换术17例患者的临床资料,其中男14例,女3例;年龄38~82（63.41±11.82）岁;合并心房颤动13例;术前纽约心脏学会（NYHA）心功能分级Ⅲ级5例,Ⅳ级12例;缺血性二尖瓣关闭不全7例,退行性二尖瓣关闭不全9例,风湿性二尖瓣关闭不全1例。结果所有患者均行全保留二尖瓣及瓣下结构的二尖瓣置换术,同期行冠状动脉旁路移植术4例;其中生物瓣11例,机械瓣6例。全组患者住院期间无死亡,均顺利出院,住院期间未并发低心排血量综合征,无左心室破裂。17例患者均随访,随访时间2~25（16.44±5.02）个月。随访期间1例患者因术后2个月发生二尖瓣重度瓣周漏死亡。其余患者人工二尖瓣功能良好,无抗凝和瓣膜引起的并发症,心功能较术前明显改善,心功能NYHA分级恢复至Ⅰ级11例,Ⅱ级4例,Ⅲ级1例。术后早期及随访期间心胸比率、左心房内径、左心室舒张期末内径及收缩期末内径与术前相比均明显减小。而术后早期左心室射血分数（LVEF）与术前相比有所降低[（50.94%±8.78%）vs.（55.31%±10.44%）,P=0.04],术前LVEF与随访期间的差异无统计学意义[（55.31%±10.44%）vs.（56.13%±9.67%）,P=0.73],随访期间LVEF与术后早期相比显著增加[（56.13%±9.67%）vs.（50.94%±8.78%）,P=0.02]。术后早期与随访期间人工二尖瓣压力减半时间（PHT）差异无统计学意义[（95.06±19.00）ms vs.（94.56±19.19）ms,P=0.91]。结论全保留二尖瓣及瓣下结构在重症二尖瓣关闭不全患者二尖瓣置换术中应用安全有效,可以改善左心室重构及术后心功能。     

新型双叶瓣ATS的临床应用效果

ＡＴＳ(ＡｄｖａｎｃｅｄｔｈｅＳｔａｎｄａｒｄ)人工心脏瓣膜是一种新型双叶机械瓣 ,设计上采用全热解碳结构 ,内环枢轴制成精细的凸状结构 ,瓣口开口角度为 85° ,缝合环为双层ｄａｃｒｏｎ制成并掺入高分子物质Ｔｅｆｌｏｎ。Ｓｔ.Ｊｕｄｅ(ＳＪ)瓣是目前临床广泛应用的双叶机械瓣膜 ,为了评价ＡＴＳ瓣膜的临床效果 ,我们进行了二者的随机比较研究。临床资料与方法　 1995年 10月至 1996年 7月我们行二尖瓣置换的病人共 6 7例。术前均征得病人同意 ,两种瓣膜随机选用 ,置入ＡＴＳ瓣 33枚 ,置入ＳＪ瓣 34枚。两组病人在年龄、性别、体表…     

三尖瓣置换术围术期及中长期临床效果分析

目的 评价三尖瓣置换术围术期及中长期疗效,并比较在三尖瓣位置生物瓣和机械瓣置换的相对优缺点和适应证,以提高该类手术的疗效. 方法 回顾性分析1992年4月至2008年2月收治的128例行三尖瓣置换术患者的围术期疗效及中长期随访结果 ,并按首次三尖瓣置换所采用的瓣膜种类不同分为机械瓣组(89例)和生物瓣组(39例).采用Kaplan-Meier曲线计算该类患者的中长期生存率和中长期人工瓣膜相关事件(包括血栓栓塞和人工瓣膜血栓形成、抗凝相关性出血、人工瓣膜毁损事件)的发生率.用 Binary logistic回归对三尖瓣置换患者早期、晚期死亡的危险因素进行多因素分析. 结果 围术期死亡19例(14.84%).随访103例(94.5%),6例失访,随访时间4.93±2.92年,随访期间死亡11例(10.7%).生物瓣组10年生存率为65.6%±17.4%,机械瓣组为68.7%±10.8%(Log-rank 检验, χ2=0.74,P=0.390).生物瓣组5年无血栓栓塞事件率为92.3%±7.4%,机械瓣组为87.1%±4.6%(Log-rank 检验,χ2=0.962,P=0.327).生物瓣组和机械瓣组10年无出血事件发生率分别为100%和79.7%±9.7%(Log-rank检验, χ2=1.483,P=0.223).9例患者行再次三尖瓣置换术,生物瓣组7年无再次手术率为71.1%±18.0%,机械瓣组10年无再次手术率为78.8%±10.2%(Log-rank检验, χ2=2.76,P=0.096).Binary logistic多因素分析结果 显示:三尖瓣置换术前有心脏手术史、腹水是早期死亡的危险因素,而术前有腹水、术前心功能分级(NYHA)Ⅲ/Ⅳ级、置换多个瓣膜为晚期死亡的危险因素. 结论 对重度三尖瓣反流,应该较早或较积极地施行三尖瓣手术,以防止右心功能进行性衰竭,而影响三尖瓣置换术的近期及中长期生存率和生活质量.在三尖瓣置换术中,机械瓣和生物瓣有相似的中长期效果.     

矫正型大动脉转位形态三尖瓣“瓣中瓣”置换术及早中期结果

目的探讨矫正型大动脉转位(cTGA)患者行形态三尖瓣"瓣中瓣"法置换术的方法及其术后早中期疗效。方法自2009年1月至2012年1月期间,阜外心血管病医院收治11例cTGA患者,其中男9例,女2例;年龄(37.8±11.7)岁;体重(73.0±11.3)kg。均采用保留全瓣及瓣下结构即"瓣中瓣"法行形态三尖瓣置换术,同期行室间隔缺损修补术2例,房间隔缺损修补术4例,肺动脉瓣成形术1例,功能右心室流出道疏通术4例,冠状动脉-肺动脉瘘修补术1例。术后随访患者纽约心脏学会(NYHA)心功能分级、心胸比率、形态右心室的射血分数及其舒张期末内径、形态左心房舒张期末内径。结果 11例患者均生存并得到随访,随访(13.0±10.6)个月。术后随访时心胸比率与术前比较差异无统计学意义(0.54±0.06 vs.0.57±0.09,t=1.581,P0.05),形态右心室射血分数与术前比较差异无统计学意义(52.8%±9.0%vs.54.9%±9.5%,t=0.712,P0.05),形态右心室舒张期末内径与术前比较差异无统计学意义[(54.3±7.5)mm vs.(56.9±9.2)mm,t=0.988,P0.05],形态左心房舒张期末内径与术前比较差异有统计学意义[(42.1±8.9)mm vs.(53.4±11.1)mm,t=3.286,P0.05],术后心功能分级较术前比较差异有统计学意义(Z=-2.640,P0.05)。结论 cTGA形态三尖瓣"瓣中瓣"置换术保留了形态右心室的几何结构形态,阻止了形态三尖瓣关闭不全对形态右心室功能的进一步损害;形态左心房功能及心功能分级明显改善;术后早中期结果满意。     

Bileaflet mechanical prostheses performance in mitral position

Objective: The experience with the Carbomedics (CM) and the St. Jude Medical (SJM) bileaflet mechanical prostheses was evaluated to determine thromboembolic and hemorrhagic complications and predictive risk factors. Methods: From 1989 to 1994, a total of 625 patients had mitral valve replacement (CM, 240; SJM, 385); 32.5% (203), concomitant procedures and 32.8% (205), previous cardiac surgery, primarily valve replacement procedures. Results: The pre-operative variables did not distinguish the populations, except for previous surgery CM 37.9% and SJM 29.6% (P<0.05). The pre-operative variables (type of prostheses, cardiac rhythm, coronary artery bypass, NYHA III/IV, advancing age, gender, urgency status and previous surgery) were not predictive of overall thromboembolism (TE), major TE, minor TE, prosthesis thrombosis and hemorrhage (P not significant; P=NS). The linearized rate of total TE events for overall MVR was 5.0%/patient-year (CM 4.4; SJM 5.4). The ≤30 day major crude rate was 0.44%, while the >30 day late major event rate was 2.0%/patient-year. Of the total TE events 91% of ≤30 days and 75%, >30 days had an INR <2.5 at or immediately prior to the event. The thrombosis rate (included in TE events) was 0.63%/patient-year (ten events, four managed successfully with thrombolysis, five successfully with reoperation, and one fatality identified at autopsy). The freedom, at 5 years, from major/fatal TE, thrombosis and hemorrhage from anticoagulation was 88.2%, and 89.5% exclusive of early events. Conclusions: This non-randomized prospective observational evaluation of the CarboMedics and St. Jude Medical prostheses has not revealed any differentiation in performance of the prostheses. The study serves as a single institution experience with the potential for future comparative evaluation.     

Bileaflet mechanical valve (St. Jude Medical valve) replacement in long-term dialysis patients.

BACKGROUND: Few reports exist on the results of bileaflet mechanical valve (St. Jude Medical prosthesis; St. Jude Medical, Inc, St. Paul, MN) replacement in long-term dialysis patients. METHODS AND RESULTS: We retrospectively reviewed 12 patients, ranging in age from 50 to 86, undergoing long-term renal dialysis who had also undergone mechanical valve replacement at our institution. Operative procedures included aortic valve replacement, aortic and mitral valve replacement, aortic valve replacement and mitral annuloplasty, mitral valve replacement, and modified Bentall's operation. There was 1 hospital death (8.3%). During the mean follow-up period of 37.1 months (range: 5-87 months), there were 2 noncardiac late deaths. Bleeding from the esophageal varix and from a duodenal ulcer occurred in 1 patient with end-stage liver cirrhosis. There were no other major cases of bleeding or cerebrovascular accidents. There were no valve-related complications. All the survivors demonstrated excellent clinical improvement under the NYHA functional classification. CONCLUSIONS: Our study demonstrated good early and long-term results of mechanical valve replacement in patients undergoing long-term dialysis. These favorable results support the continued use of mechanical valves in dialysis patients.     

Preliminary Clinical Experience with the Jyros Bileaflet Mechanical Prosthesis

The Jyros bileaflet mechanical prosthesis is unique among bileaflet valve designs in that there is no fixed hinge mechanism and after implantation, the leaflets are free to rotate as determined by blood flow through the orifice. Between November 1992 and April 1994, 56 Jyros valves were implanted in 44 patients at 45 operations. There were 31 males and 13 females (ratio 2.3:1), with a mean age of 3714 and a range owelve patientsplacement (AVR) (26.7%), 19 had mitral valve replacement (MVR) (42.2%), and 14 had AVR plus MVR (DVR) (31.1%). In three DVR patients the Jyros valve was implanted only in the mitral position. There was one hospital death following DVR (2.3% mortality). Total follow-up of 341 patient-months (28.4 patient-years) is 100% complete. There were no late deaths. There was one reoperation for acute mitral prosthetic thrombosis (3.5%/patient-year). Another Jyros valve was inserted; leaving 53 valves at risk in 42 patients at the close of follow-up. There were no episodes of thromboembolism, transient ischemic attacks, endocarditis, hemolysis, or valve dysfunction, but three patients had four episodes of anticoagulant-related hemorrhage. Echocardiographic follow-up data was available in 29 patients and indicated satisfactory hemodynamic performance. Our early results with this unique prosthesis have been excellent; however, more extensive use and far longer follow-up are required to determine whether the theoretical advantages offered by the innovative design are manifest in lower complication rates than for other conventional bileaflet prostheses in current use.     

Doppler Sonographic Evaluation of the CarboMedics Bileaf let Valve Prosthesis: One-Year Experience

Between April 1989 and March 1991, 237 CarboMedics bileaflet valve prosthesis carriers (165 aortic and 72 mitral valves, mean age 54.4 years) were studied prospectively with pulsed- and continuous-wave Doppler at a mean interval of 11.4 months following surgery in order to establish ranges of normal flow velocities and pressure gradients. Physical examination revealed no signs of prosthetic dysfunction or heart failure. Postoperative left ventricular function as measured by fractional shortening was 37% for aortic valve carriers and 30% for mitral valve carriers (p = NS). Mean peak velocity (+/- SD) across the aortic valve was 2.6 m/sec (+/- 0.4) and calculated instantaneous peak pressure gradient ranged from 11 to 58 mmHg (mean 28.1 +/- 10.3). It has to be emphasized that occasional patients with normally functioning valve prostheses can show unusual high gradients. Ring diameters between 21 and 27 mm showed no significant difference with regard to flow velocities and pressure gradients, whereas in 19-mm valves, significantly higher values could be demonstrated. The 123 aortic valve carriers with normal left ventricular function (fractional shortening greater than 25%) showed significantly higher pressure gradients than the 19 patients with reduced left ventricular function (28.6 +/- 11.6 mmHg vs 16.2 +/- 5.1 mmHg, p less than 0.05). In the mitral position, the mean of peak velocity (+/- SD) was 1.7 +/- 0.4 m/sec and pressure half-time was 108 +/- 26 msec, representing a calculated valve area between 1.4 to 3.1 cm2 (mean orifice size 2.1 +/- 0.5 cm2). No significant difference between valves of different sizes was found.(ABSTRACT TRUNCATED AT 250 WORDS)     

Bivalvular mechanical mitral-aortic valve replacement in 254 patients: long-term results--a 22-year follow-up

BACKGROUND: We have retrospectively studied 254 patients who underwent a bivalvular mechanical mitral-aortic replacement in the cardiovascular and thoracic surgery unit of Nantes from 1979 to 1989. The follow-up was 22 years (1979 to 2001). The last patient was operated on 12 years before the end of the follow-up. METHODS: All mitral prostheses were St. Jude Medical (SJM) bileaflet valves, and the aortic prostheses were 124 monodisc Bj?rk-Shiley valves, 3 Sorin prostheses, and 127 St. Jude Medical bileaflet prostheses. The mean age was 56.8 +/- 8.5 years with a sex ratio equal to 1. Rheumatism as the etiology predominated with 79.5%. Ninety-seven percent of the patients were followed for a total of 2,779 patient-years and a mean of 11.7 years. RESULTS: Operative mortality was 7.08%. Freedom from overall mortality and valve-related mortality at 22 years were 45.7% +/- 3.6% and 73.1% +/- 3%, respectively. The linearized rates of thromboembolic and hemorrhagic events were 1.07% and 0.9% per patient-year, respectively. Multivariate analysis showed age (p < 0.002), sex (p < 0.01), and degenerative etiology (p = 0.04) as independent factors of late mortality, and age, sex, degenerative disease, and tricuspid pathology were related to valve-related mortality. CONCLUSIONS: This study shows good results after mechanical mitral-aortic replacement in terms of survival rate and quality of life in surviving patients, and outlines the factors influencing long-term results as compared with isolated mitral valve replacement.     

Mitral and mitro-aortic valve replacement with Sorin Bicarbon valves compared with St. Jude Medical valves

OBJECTIVE: We assessed the clinical results of two bileaflet mechanical valves: the St. Jude Medical (SJM) and the Sorin Bicarbon (Sorin Bicarbon) used either in single mitral valve replacement (MVR) or in double, aortic and mitral, valve replacement (DVR). METHODS: Between September 1990 and November 1995, 217 patients received either a St. Jude Medical (n=134) or a Sorin Bicarbon (n=86): 136 mitral valve replacement with 83 St. Jude Medical and 53 Sorin Bicarbon and 84 double valve replacement with 51 St. Jude Medical and 33 Sorin Bicarbon. There was no difference between both St. Jude Medical and Sorin Bicarbon cohorts in respect of mitral valve physiopathology, etiology of valve disease, associated lesions, echocardiographic and hemodynamic data. The only significant preoperative difference was the age of patients within the double valve replacement group and the size of implanted valves within the mitral valve replacement group. Follow-up was 100% complete with a mean of 39+/-18 months, ranging between 6 and 68 months. The total follow-up was 657 patient-years (pt-y): 396 pt-y in the mitral valve replacement group and 274 pt-y in the double valve replacement group. RESULTS: Hospital mortality (St. Jude Medical: 2.2%; Sorin Bicarbon: 6.9%) and late mortality (St. Jude Medical: 8.4%; Sorin Bicarbon: 6.3%) were not significantly different. Ten deaths were considered valve-related (St. Jude Medical 6, Sorin Bicarbon 4). The estimated 4-yr overall survival, including hospital mortality, was for St. Jude Medical--mitral valve replacement: 89+/-4% and St. Jude Medical--double valve replacement: 93+/-4%, and for Sorin Bicarbon--mitral valve replacement: 87+/-5% and Sorin Bicarbon--double valve replacement: 91+/-5%. The linearized incidence (% per pt-y) of valve-related complications was 6.39 in the St. Jude Medical cohort and 9.2 in the Sorin Bicarbon cohort. The linearized incidence (% pt-y) of the prevalent complication, valve thromboembolism and bleeding, was for St. Jude Medical-mitral valve replacement: 3.41, St. Jude Medical--double valve replacement: 3.16 and for Sorin Bicarbon--mitral valve replacement: 2.17 and Sorin Bicarbon--double valve replacement: 3.67. The differences between each group of an estimated 4-yr freedom from combined thromboembolism and bleeding were not significant (St. Jude Medical--mitral valve replacement: 90+/-4%, St. Jude Medical--double valve replacement: 84+/-6%, and for Sorin Bicarbon--mitral valve replacement: 94+/-3% and Sorin Bicarbon--double valve replacement: 75+/-17%). CONCLUSIONS: In this clinical non-randomized study, there was no evidence of any significant difference between St. Jude Medical and Sorin Bicarbon valves over a 4-yr follow-up.     

Operative results of tricuspid valve replacement with St. Jude Medical prosthesis

Since 1974, 14 patients underwent tricuspid valve replacement (TVR) with prosthetic heart valves. Hardy's operation was undergone in 2 patients with Ebstein's anomaly and mitral valve surgery or multiple valve surgery were undergone in 9 patients with rheumatic valvular disease, concomitantly. Four types of prosthetic heart valves were used in the tricuspid position, i.e. 2 Starr-Edwards prostheses, 1 Hancock xenograft, 1 Bj?rk-Shiley prosthesis and 12 st. Jude Medical prostheses. The operative mortality rate was 14.3% (2/14) and 2 hospital deaths were due to low cardiac output syndrome. Twelve survivors have been followed with a maximum follow-up of 13 years and the mean of 4.7 years. There were 3 late deaths due to congestive heart failure and prosthetic valve endocarditis (PVE) of the aortic Bj?rk-Shiley prosthesis. There was 1 PVE of the tricuspid Starr-Edwards prosthesis and 1 thrombosis of the tricuspid Bj?rk-Shiley prosthesis, but no thrombosis and no other valve-related complications of SJM prostheses in the tricuspid position. The post-operative NYHA function class improved satisfactorily in 9 survivors. Judging from our relatively satisfactory post-operative results in TVR cases using SJM prostheses, SJM prosthesis in the tricuspid position is one of advisable prosthesis to get satisfactory hemodynamic improvement post-operatively.     

A comparative study of the St. Jude Medical and Bj?rk-Shiley convexo-concave prostheses in isolated valve replacement

This is a study of 199 consecutive patients who survived isolated mitral or aortic valve replacement with a Bj?rk-Shiley (B-S) or St. Jude Medical (SJM) prostheses. Mean follow-up was 36 months. Preoperative status was similar for both groups (B-S or SMJ). Five year survival rates for mitral valve replacement (MVR) were 91% for B-S and SJM, and for aortic valve replacement (AVR) 96% vs 91% for SJM (p less than 0.06). Linearized incidence of thromboembolism in MVR was 5.62% patient year for BS and 5.23% patient year for SJM (p = NS). Classical risk factors for thromboembolism were evaluated on a univariate analysis: no single risk factor was identified. Only the association of two or more was possibly significant. The presence of inadequate anticoagulation (prothrombin index greater than 50%) was the main risk factor for thromboembolism, as the incidence rate was 19% per patient year when poorly anticoagulated versus 4.6% per patient year incidence in the whole series (p less than 0.01).     

Clinical outcome in patients with 19-mm and 21-mm St. Jude aortic prostheses: comparison at long-term follow-up

BACKGROUND: Small-sized prostheses for aortic valve replacement may result in residual left ventricular outflow tract obstruction. Aim of the study was to verify whether implantation of 19-mm versus 21-mm St. Jude Medical standard prostheses (St. Jude Medical, Inc, St. Paul, MN) influences long-term clinical outcome. METHODS: Two hundred twenty-nine patients who underwent aortic valve replacement with 19 mm (group 1, 53 patients) or 21-mm St. Jude Medical standard prostheses (group 2, 176 patients) were included in the study. Mean follow-up of current survivors was 10+/-4 years. RESULTS: Operative mortality was 7.5% in group 1 and 8.5% in group 2. At discharge, an important patient-prosthesis mismatch (effective orifice area index < or = 0.60 cm2/m2) was present in 18% of group 1 versus 5% in group 2 (p = 0.004). Among patients with body surface area less than 1.70 m2, such mismatch was present in 15% of group 1 versus 2% of group 2 (p = 0.008). At last follow-up New York Heart Association (NYHA) functional class (p < 0.001), left ventricular mass reduction (p = 0.02), mean (p = 0.002) and peak transprosthetic gradients (p < 0.001), and effective orifice area index (p = 0.005) were significantly better in group 2. Freedom from sudden death (92%+/-5% vs 99%+/-1%, p = 0.01), valve-related death (84%+/-6% vs 90%+/-5%, p = 0.02), and cardiac events (56%+/-13% vs 86%+/-4%, p = 0.008), were significantly lower in group 1. Effective orifice area index was an independent predictor of late cardiac events. CONCLUSIONS: Although long-term results after aortic valve replacement with small-sized St. Jude Medical standard prostheses are satisfactory, 19-mm valve recipients show a high prevalence of important patient-prosthesis mismatch with less evident functional improvement and higher rate of cardiac events, suggesting a very cautious use of this prosthesis.