Cardiac valve replacement in the elderly]

From January 1980 through December 1990, seventy one consecutive patients over 60 years of age (mean age 64 +/- 4 years) and 231 patients younger than 60 years underwent cardiac valve replacement procedures. In the elderly group, aortic valve replacement was performed in nineteen patients, mitral valve replacement in thirty-three patients both aortic and mitral valve replacement in sixteen patients, and both mitral and tricuspid valve replacement in three patients. Aortocoronary bypass was performed in four and tricuspid annuloplasty in 19 patients simultaneously. Two patients were operated on emergency. As for preoperative status, 63 patients (88.7%) were in New York Heart Association (NYHA) Functional Class III or IV. Mechanical valves were implanted in all aortic position and 16 mitral position. Bioprosthetic valves were placed in 34 mitral position and 3 tricuspid position. Mean follow-up period was 42 +/- 33 months. The early mortality rate was 11% (8 patients) and the actuarial survival rate was 88 +/- 5% at five years and 74 +/- 10% at ten years. Postoperative functional improvement was excellent in 85.7% of the survivors. In the younger age group, 77.9% belonged to NYHA class III or IV preoperatively. The early mortality was 3.0% (7 patients) and the actuarial survival rate was 95 +/- 2% at five years and 86 +/- 2% at ten years. And postoperatively 91.3% were in NYHA class I or II. In conclusion, cardiac valve replacement in the elderly can be performed with an acceptable mortality and excellent functional improvement.     

More than ten years' follow-up of the Hancock porcine bioprosthesis in Japan.

From February 1975 through October 1981, 256 Hancock porcine bioprostheses (Johnson & Johnson Cardiovascular, King of Prussia, Pa.) (60 aortic, 169 mitral, and 27 pulmonary/tricuspid position) were implanted in 220 patients (104 male and 116 female, aged 9 to 67 years; mean 43.3) at Kyushu University Hospital in Japan. The procedures include 41 aortic valve replacements, 121 mitral valve replacements, 4 pulmonary valve replacements, 6 tricuspid valve replacements, and 48 combined valve replacements (31 aortic plus mitral, 13 mitral plus tricuspid, and 4 aortic plus mitral plus tricuspid). Hospital mortality was 6.4%. Follow-up was 98% during 8 to 14 (mean 10.5) years. Cumulative follow-up was 1836 patient-years and 2078 valve-years. At 10 years the overall actuarial survival rate, including hospital morality, was 70% +/- 3%, and freedom from valve-related mortality with sudden death was 87% +/- 3%. More than half of the current survivors required no anticoagulant therapy. Freedom from thromboembolism or anticoagulant-related hemorrhage (or both) and prosthetic valve endocarditis was common. Freedom from structural valve failure and reoperation declined more than 9 years after replacement of left-sided heart valves but not after replacement of right-sided heart valves. Sixty-seven patients underwent 68 repeat operations, and there were four deaths (5.9%). The rate of freedom from overall valve-related complications at 10 years was 62% +/- 8% for aortic valve replacement, 53% +/- 5% for mitral valve replacement, 80% +/- 13% for pulmonary/tricuspid valve replacement, and 42% +/- 9% for combined valve replacement. There was a significant difference between pulmonary/tricuspid valve replacement and combined valve replacement (p less than 0.05). The Hancock bioprosthesis is suitable for the replacement of valves in the right side of the heart but not for combined valve replacement.     

复杂性感染性心内膜炎的外科治疗

目的评价瓣周脓肿、心肌脓肿以及瓣膜严重毁损等复杂性感染性心内膜炎手术治疗的近、远期疗效.方法回顾性分析1988年12月至2002年6月手术治疗的复杂性心内膜炎患者57例临床资料,均为原发性心内膜炎,其中感染侵犯主动脉瓣25例、二尖瓣16例、二尖瓣和主动脉瓣16例.术中发现瓣叶严重毁损32例、主动脉瓣周脓肿19例、主动脉根部环形脓肿导致左心室-主动脉连接破坏4例、二尖瓣后瓣环脓肿11例、心肌脓肿6例、瓣膜赘生物形成55例.脓肿清除后遗留残腔采用间断褥式缝合6例、自体心包片修补19例、牛心包片修补6例、聚四氟乙烯膨体补片修补4例;施行以带瓣管道作升主动脉根部替换和左、右冠状动脉移植术4例,主动脉瓣替换术21例,二尖瓣替换术16例,主动脉瓣及二尖瓣双瓣替换术16例.结果早期死亡6例(11%),死亡主要原因为低心输出量综合征、人造心脏瓣膜性心内膜炎和多脏器功能衰竭.随访4个月至14年,平均(5.93±0.20)年.晚期死亡5例,晚期主要并发症为人造瓣膜性心内膜炎.术后1年心功能恢复NYHA分组Ⅰ～Ⅱ级占96%(44/46);5年再手术免除率为(84±3)%,5年实际生存率为(61±9)%.结论复杂性心内膜炎局部组织破坏较多,应限期手术或急症手术,清创后残腔的处理是影响手术本身能否成功以及术后近、远期效果的关键.     

Twenty-year comparison of tissue and mechanical valve replacement

OBJECTIVE: We sought to compare outcomes with tissue and St Jude Medical mechanical valves over a 20-year period. METHODS: Valve-related events and overall survival were analyzed in 2533 patients 18 years of age or older undergoing initial aortic, mitral, or combined aortic and mitral (double) valve replacement with a tissue valve (Hancock, Carpentier-Edwards porcine, or Carpentier-Edwards pericardial) or a St Jude Medical mechanical valve. Total follow-up was 13,390 patient-years. There were 666 St Jude Medical aortic valve replacements, 723 tissue aortic valve replacements, 513 St Jude Medical mitral valve replacements, 402 tissue mitral valve replacements, 161 St Jude Medical double valve replacements, and 68 tissue double valve replacements. The mean age was 68 +/- 13.3 years (St Jude Medical valve, 64.5 +/- 12.9; tissue valve, 72.0 +/- 12.6). RESULTS: There were no overall differences in survival between tissue and mechanical valves. Multivariable analysis indicated that the type of valve did not affect survival. Analysis by age less than 65 years or 65 years or older and presence or absence of coronary disease revealed similar long-term survival in all subgroups. The risk of hemorrhage was lower in patients receiving tissue aortic valve replacements but was not significantly different in patients receiving mitral valve or double valve replacements. Thromboembolism rates were similar for tissue and mechanical valve recipients. However, reoperation rates were significantly higher in patients receiving both aortic and mitral tissue valves. The reoperation hazard increased progressively with time both in patients receiving aortic and in those receiving mitral tissue valves. Overall valve complications were initially higher with mechanical aortic valves but not with mechanical mitral valves. However, valve complication rates later crossed over, with higher rates in tissue valve recipients after 7 years in patients undergoing mitral valve replacement and 10 years in those undergoing aortic valve replacement. CONCLUSIONS: Tissue and mechanical valve recipients have similar survival over 20 years of follow-up. The primary tradeoff is an increased risk of hemorrhage in patients receiving mechanical aortic valve replacements and an increased risk of late reoperation in all patients receiving tissue valve replacements. The risk of tissue valve reoperation increases progressively with time.     

Elderly valve replacement with bioprostheses and mechanical prostheses. Comparison by composites of complications

AIM: The goal of aortic valve replacement (AVR) surgery in the elderly (= or >75 years) is to extend survival and minimize valve-related morbidity, mortality and reoperation. As the elderly population lives longer, those with implanted valves are at risk of suffering valve related complications. We hypothesize that bioprostheses are appropriate for the elderly. METHODS: The follow-up evaluation of 966 patients with valves (AVR, 666; mitral valve replacements [MVR], 226; multiple valve replacements [MR], 74) implanted between 1975 and 1999 was examined. There were 879 bioprotheses (BP) and 87 mechanical prostheses (MP). The mean age was 78.9+/-3.3 years (range 75-94.6 years). Concomitant coronary artery bypass was performed in AVR in 51.7%, MVR in 50.4% and MR in 28.4%. Valve type, valve lesion, coronary artery bypass (previous/concomitant), age and gender were considered as independent predictors of composites and survival. The total follow-up was 3905 patient-years. RESULTS: Early mortality was for AVR 9.6% (64), MVR 15.0% (34) and MR 25.7% (19). The late mortality was for AVR 8.8%, MVR 10.4% and MR 8.8%/patient-year. The only independent predictor of survival and valve-related mortality, morbidity and reoperation was age for survival in those with AVR, hazard ratio 1.15 [CL 1.03-1.27] p=0.0094). The BP reoperative rate was 0.5%/patient-year (reoperation was fatal in 6/15) of total, MP reoperative rate was 0% [reasons for reoperation structural valve deterioration (4), non-structural dysfunction (6), prosthetic valve endocarditis (5), reoperation fatality due to non-structural dysfunction (2), prosthetic valve endocarditis (4)]. Overall patient survival at 10 and 15 years, respectively, was 30.5+/-2.4% and 3.6+/-2.2% irrespective of valve position and type. Overall actual and actuarial freedom from valve-related morbidity at 15 years was 96.8+/-0.9% and 93.7+/-2.3%, respectively. Actual and actuarial overall freedom from valve-related mortality at 15 years was 84.3+/-2.4% and 58.4+/-0.9%, respectively. Overall actual and actuarial freedom from valve related reoperation at 15 years was 95.8+/-1.6% and 74.8+/-16.9%, respectively. CONCLUSIONS: BP valves are further confirmed to be a good option for AVR in patients = or >75 years of age.     

Porcine versus pericardial bioprostheses: a comparison of late results in 1,593 patients

From 1976 to 1988, 1,593 patients underwent valve replacement with a porcine (878 patients) or a pericardial bioprosthesis (715 patients). There were 701 aortic, 678 mitral, and 214 multiple-valve replacements. Follow-up was obtained for 1,559 patients (98%). Early mortality was 9% (79 patients) in the porcine valve group and 5% (37 patients) among patients with a pericardial valve (p less than 0.01). Late survival after replacement with porcine valves was 80% +/- 1% and 62% +/- 3% at 5 and 10 years, respectively. With pericardial valves, 5-year survival was 79% +/- 2%. Among valve-related complications, rates of freedom from thromboembolism, endocarditis, and hemorrhage after 6 years were similar for both valve groups. Freedom from reoperation at 6 years was also similar after aortic (96% versus 91%) or multiple-valve replacement (95% versus 88%). However, for mitral valve replacement, freedom from reoperation was significantly better with porcine valves than with pericardial valves at 6 years (92% versus 68%; p less than 0.001). This difference was mainly due to the Ionescu-Shiley valve, which accounted for 83% of primary tissue failures among pericardial bioprostheses implanted in the mitral position (10/12 patients). After 6 years, freedom from primary tissue failure of mitral valves was 92% +/- 2% with porcine and 70% +/- 11% with pericardial bioprostheses (p less than 0.0001). The degree of clinical improvement among survivors was similar with both valve types. Thus, in the aortic position, pericardial valves compare with porcine valves up to 6 years, whereas in the mitral position, the durability of the former is significantly less, mainly because of the suboptimal performance of the Ionescu-Shiley pericardial bioprosthesis.     

Mid-term follow-up in patients with Biocor porcine bioprostheses

BACKGROUND: Prosthetic cardiac valves have increased life expectancy of patients (pts) with valvular heart disease. Bioprosthetic complications required devices replacements within 10 years of implantation; structural valve deterioration (SVD) has emerged as the major cause of reoperation. We reviewed survival and prosthetic complications of Biocor porcine bioprostheses implanted in mitral, aortic and mitro-aortic position. METHODS: Between January 1991 and January 2001 446 pts (192 males; 254 females; mean age 73.4+/-6.7 year, range 40-91) received 258 aortic, 138 mitral and 50 mitro-aortic Biocor porcine valves; of these 83 pts have previous different types of prosthetic devices (15 aortic, 53 mitral and 15 double). Concomitant cardiac procedures, namely myocardial revascularization, were performed in 91/446 pts (20.5%). All explanted bioprostheses (BPS) were available for pathologic investigation. Follow-up included 1319 pt.-years and was 98% complete with a median time of 36 pt.-months. RESULTS: Perioperative mortality was 6.8% (30/446 pts; 12 aortic, 17 mitral and 1 double) and was mostly related to reoperations. At the end of follow-up 18.5% of pts died (77/416), 12 deaths were valve-related with freedom from valve related mortality of 94% at 9 years. Survival was 54% at 9 years. It was 63%, 41% and 62% for aortic, mitral and double valve replacement, respectively. At follow-up 87% of pts. were in NYHA I-II class and 13% were in III-IV class; 55% were in sinus rhythm, 36% in atrial fibrillation and 9% had a pace-maker. Eighty-five percent of pts were anticoagulated. There were 6 thromboembolic and 5 anticoagulant-related haemorrhagic episodes with no significant difference between aortic and mitral position (p=0.7). The event freedom was respectively 92% and 98.5% at 9 years. Prosthetic valve endocarditis (PVE) and non-SVD freedom were 96% and 93% at 9 years. SVD due to tissue degeneration, calcification and cusp's tears affected 2 pts with 94% freedom at 9 years. Overall freedom from all valve-related complications was 80% at 9 years and freedom from reoperation was 92% at 9 years. CONCLUSIONS: (1) Our intermediate-term follow-up of the Biocor porcine valve (BPS) showed excellent durability in all positions. (2) The aortic patients and especially the oldest group had better results than the mitral patients (41% vs. 63% 9 years survival, p=0.0004). (3) Higher mitral risk was related to higher prevalence of reoperations. (4) The incidence of anticoagulation-related complications is low in both aortic and mitral position without significant difference (p=0.7). 4) A longer follow-up is required to get more information about SVD timing.     

Mitral Valve Replacement with the Hancock Bioprosthesis: Five- to Ten-Year Follow-up

One hundred eleven patients undergoing mitral valve replacement, either alone (56) or in conjunction with another type of prosthetic valve, prior to 1975 were evaluated. Hospital mortality was 9.9%. Cumulative follow-up is 505 patient-years (mean, 5.4 years). Seventy patients have been followed between 5 and 10 years. Late mortality for mitral valve replacement alone is 4.3 ± 1.3% per patient-year; actuarial survival is 82 ± 6% at 5 years and 65 ± 11% at 10 years. The incidence of emboli was 3.3 ± 0.9% per patient-year for all patients with bioprostheses (62) and 4.2 ± 1.7% per patient-year for bioprostheses and concomitant mechanical aortic valves (32). In patients with only bioprostheses, two of twelve emboli occurred within the first 6 postoperative months and there were three fatal cerebral emboli (0.8 + 0.5% per patient-year). The incidence of hemorrhagic complications is 4.9 ± 1.9% for anticoagulated patients with bioprostheses and mechanical aortic valves; one hemorrhage was fatal (0.7 ± 0.7% per patient-year). Intrinsic mitral bioprosthesis failure occurred in 10 patients; 2 died. Five patients had valve failure secondary to perivalvular regurgitation (3) or endocarditis (2). Actuarial late survival free from intrinsic mitral bioprosthetic failure was 99 ± 1% at 5 years, 92 ± 4% at 7 years, 70 ± 12% at 9 years, and 61 ± 13% at 10 years.It is unknown at the present time whether the long-term risk of late intrinsic valve failure and reoperation will outweigh the low incidence of emboli and avoidance of anticoagulant-related hemorrhage. Until further information becomes available, the Hancock bioprosthesis is used for mitral valve replacement only in patients older than 60 years or in patients with contraindications for anticoagulant therapy.     

An eight-year experience with porcine bioprosthetic cardiac valves

A total of 589 porcine bioprostheses were implanted in 509 patients from January, 1976, through December, 1983. Of the valves implanted, 390 were Hancock and 199 were Carpentier-Edwards. A total of 1,633 patient-years was accrued, with a mean follow-up of 38 months per patient. Two hundred eight patients had aortic valve replacement, 209 had mitral valve replacement, and 79 had multiple valve replacements, of which 46 were aortic and mitral replacements. The mortality for isolated aortic valve replacement was 5.8%; for isolated mitral replacement, 8.6%, and for all patients, 10.9%. Late mortality was 3.9% per patient-year. The actuarial survival rate at 5 years was 79% for aortic, 68% for mitral, and 76% for aortic-mitral valve replacement. There were 12 thromboembolic events (0.73% per patient-year). Two episodes occurred in patients with an aortic bioprosthesis, nine in patients with a porcine mitral valve, and one in a patient with mitral and tricuspid bioprosthetic valves. The probability of remaining free of thromboembolism at 5 years was 99% for the group having aortic valve replacement, 93% for those having mitral replacement, and 100% for the group having aortic-mitral valve replacements. Thirteen episodes of endocarditis occurred (0.8% per patient-year). Seven of the 13 patients died as a direct result of endocarditis. The probability of remaining free of prosthetic endocarditis at 5 years was 97% for the aortic valve replacement group, 95% for the mitral group, and 97% for the aortic-mitral group. There were 20 instances of xenograft failure (1.2% per patient-year). The probability of remaining free of valve failure at 5 years was 96% for the aortic valve replacement group, 93% for the mitral group, and 93% for the aortic-mitral replacement group. Primary tissue failure of a prosthesis occurred in seven patients, all with Hancock valves (0.43% per patient-year). As yet there has been no primary tissue failure of the Carpentier-Edwards prosthesis. There also appears to be a lower incidence of thromboembolism (Edwards, 0.3% per patient-year; Hancock, 0.8% per patient-year) and endocarditis (Edwards, 0.6% per patient-year; Hancock, 1.0% per patient-year). The low incidence of complications with the porcine bioprosthetic valve, especially the Carpentier-Edwards, encourages us to recommend its continued use, especially in situations in which anticoagulation is contraindicated.     

Thromboembolism in patients with pericardial valves in the absence of chronic anticoagulation: 12 years' experience.

Between January 1977 and January 1989, 465 pericardial bioprostheses were implanted in 424 patients. The mean age of patients was 59.1 years (range 16-81 y.) At the time of surgery, 68% of the patients suffered from chronic atrial fibrillation. Mitral valve replacement was performed in 167 patients, aortic valve replacement in 216, multiple replacement in 40 (36 mitral and aortic, 3 mitral and tricuspid, and 1 mitral, aortic and tricuspid), and 1 pulmonary valve replacement. The different types of pericardial valve used were: Ionescu-Shiley 408, Mitral Medical 23, Bioflo 30, and Hancock 4. Hospital mortality was 10.1% with an attrition rate of 1.8 episodes per 100 patients/year. The 12-year actuarial survival rate was 65.1%. No patient underwent long-term anticoagulant treatment. The first 144 patients undergoing mitral and multiple valve replacements received temporary anticoagulation for the first 8 weeks after surgery. There was no valve thrombosis observed. Altogether 19 thromboembolic events (6 early and 13 late) were clinically documented. One patient died after an embolic event. The linearized rates of thromboembolism were 1.64 episodes per 100 patients/year for mitral and multiple valve replacements and 0.33 episodes per 100 patients/year for aortic valve replacement, with an overall rate of 1.0 episodes per 100 patients/year. Excluding early thromboembolism, the linearized rate was 1.02 episodes per 100 patients/year overall. The actuarial freedom from embolism was 92.4% overall, 88.2% for the mitral and multiple valve replacement group, and 97.6% for the aortic valve replacement group at a maximum follow-up of 12 years.(ABSTRACT TRUNCATED AT 250 WORDS)     

Late incidence and determinants of reoperation in patients with prosthetic heart valves.

OBJECTIVES: Reoperation is a relatively common event in patients with prosthetic heart valves, but its actual occurrence can vary widely from one patient to another. With a focus on bioprosthetic valves, this study examines risk factors for reoperation in a large patient cohort. METHODS: Patients (N=3233) who underwent a total of 3633 operations for aortic (AVR) or mitral valve replacement (MVR) between 1970 and 2002 were prospectively followed (total 21,179 patient-years; mean 6.6+/-5.0 years; maximum 32.4 years). The incidence of prosthetic valve reoperation and the impact of patient- and valve-related variables were determined with actual and actuarial methods. RESULTS: Fifteen-year actual freedom from all-cause reoperation was 94.1% for aortic mechanical valves, 61.4% for aortic bioprosthetic valves, 94.8% for mitral mechanical valves, and 63.3% for mitral bioprosthetic valves. In both aortic and mitral positions, current bioprosthesis models had significantly better durability than discontinued bioprostheses (15-year reoperation odds-ratio 0.11+/-0.04; P<0.01 for aortic, and 0.42+/-0.14; P=0.009 for mitral). Current bioprostheses were significantly more durable in the aortic position than in the mitral position (14.3+/-6.8% more freedom from 15-year reoperation; (P=0.018)). Older age was protective, but smoking was an independent risk factor for reoperation after bioprosthetic AVR and MVR (hazard ratio for smoking 2.58 and 1.78, respectively). In patients with aortic bioprostheses, persistent left ventricular hypertrophy at follow-up and smaller prosthesis size predicted an increased incidence of reoperation, while this was not observed in patients with mitral bioprostheses. CONCLUSIONS: These analyses indicate that current bioprostheses have significantly better durability than discontinued bioprostheses, reveal a detrimental impact for smoking after AVR and MVR, and indicate an increased reoperation risk in patients with a small aortic bioprosthesis or with persistent left ventricular hypertrophy after AVR.     

A five-year appraisal and hemodynamic evaluation of the Bj?rk-Shiley Monostrut valve

Two hundred forty-four Bj?rk-Shiley Monostrut valves were implanted in 225 consecutive patients from October 1983 to December 1988. Aortic valve replacement was performed in 90 patients, mitral valve replacement in 118, and double valve replacement in 16 patients. One patient had tricuspid valve replacement. There were 100 female patients and 125 male patients with a mean age of 54 years (range 2 to 71 years). Present data were completely available for all patients. The cumulative follow-up was 541 patient-years with a mean of 2 years, 5 months. The closing date for follow-up was July 1989, and the closing interval was 2 months. The early mortality rate was 3.1%, and the late mortality rate, 3.1%. The 5-year survival rate was 88% +/- 2.0%: 87% +/- 3.0% for aortic valve replacement, 91% +/- 3.3% for mitral valve replacement, and 75% +/- 9.6% for double valve replacement. The actuarial rates of freedom from thromboembolism at 5 years were 93% +/- 3.2% for aortic, 96% +/- 1.4% for mitral, and 94% +/- 6.1% for double valve replacement. There were no instances of structural valve deterioration. Actuarial rate of freedom from valve-related morbidity and mortality was 86% +/- 2.0% at 5 years: 86% +/- 9.5% for aortic, 87% +/- 3.3% for mitral, and 75% +/- 7.3% for double valve replacement. Effective valve areas (average) of 12 mitral and 12 aortic valve prostheses were calculated at rest and during bicycle exercise: 2.4 cm2 at rest and 2.8 cm2 during exercise in 27 mm aortic valves, 2.4 cm2 at rest and 3.0 cm2 during exercise in 25 mm aortic valves, 2.0 cm2 at rest and 2.4 cm2 during exercise in 27 mm mitral valves, and 2.6 cm2 at rest and 2.5 cm2 during exercise in 29 mm mitral valve. On the basis of our follow-up period of 5 years, we have judged the Bj?rk-Shiley Monostrut valve reliable, with a low incidence of valve-related morbidity and with acceptably satisfactory hemodynamic characteristics at rest and during exercise.     

Primary failure of pericardial valvular heterografts

From July 1981 to October 1984, 79 Hancock pericardial valves were implanted in 74 patients surviving the hospital period and with a mean age of 64.2 years. Fifty-two patients underwent aortic valve replacement, 16 had mitral valve replacement, 5 bad a double replacement and 19 associated procedures were performed. The mean survival is 48 months. Until 1st June 1987, 11 primary failures have required reoperation (14.9%), 4 in the mitral position (4.6% patient-years), 7 in the aortic position (3.01% patient-years). The time to reoperation was 48.4 months for the aortic orifice and 36.5 months for the mitral orifice. The lesions most frequently encountered were tears (7 cases), calcifications (5 cases) and stretching of valvular tissue (2 cases); two patients died during the postoperative phase of this operation. Despite the small number of patients followed, this series demonstrates of high incidence of dysfunction due to primary tissue degeneration as, after the 5th year, the actuarial rate of absence of primary lesion is 85.3 +/- 8% with no significant difference between the aortic and the mitral orifices, although dysfunction appears to occur more rapidly in mitral prostheses. These results are much less favourable than those obtained with Ionescu bioprostheses in the aortic position of those obtained with porcine bioprostheses in either position. This justifies very regular clinical and echocardiographic follow-up of patients with Hancock pericardial valvular heterografts.     

Comparison of long-term results of Carpentier-Edwards and Hancock bioprosthetic valves

The long-term survival following valve replacement with Carpentier-Edwards or Hancock bioprostheses was compared between the two valve models and between the two groups totaling 407 patients who were discharged after valve replacement beginning in 1974. The two groups of patients were treated in a nonrandomized fashion. The actuarial survival for 299 patients with Carpentier-Edwards valves was 94 +/- 1.5% (+/- standard error) and 93 +/- 1.7% after 5 and 8 years of follow-up, respectively. Comparable figures for 108 patients undergoing valve replacement with Hancock valves were 89 +/- 3.0% and 83 +/- 3.7%, respectively (p = not significant [NS]). The probability of freedom from death and valve removal after 5 and 8 years of follow-up was 91 +/- 1.8% and 79 +/- 4.6%, respectively, with the Carpentier-Edwards valve and 84 +/- 3.5% and 75 +/- 4.3%, respectively, with the Hancock valve (p = NS). An accelerated rate of attrition for both valves was observed in the mitral position. There were no significant differences in actuarial survival between the two valves in the mitral or the aortic position or in the incidence of major valve-related complications.     

A 5 1/2 year experience with the St. Jude Medical cardiac valve prosthesis. Early and late results of 737 valve replacements in 671 patients

Between June 12, 1978, and June 12, 1983, 737 St. Jude Medical valves were implanted in 671 patients (431 males, 240 females) ranging in age from 9 months to 82 years (mean 55 years); 16 of these patients (2.3%) were less than or equal to 15 years and 82 (12.2%) were greater than or equal to 70 years. Associated procedures were performed in 28.2% of the 500 aortic valve replacements, 13.3% of the 105 mitral valve replacements, and 10.6% of the 66 double mitral and aortic valve replacements. Hospital mortality (less than or equal to 30 days) was 3.6% (18/500 patients) for aortic, 4.7% (5/105 patients) for mitral, and 0% for double valve replacement. Only one of these 23 hospital deaths was possibly valve-related. Complete follow-up was achieved during December, 1983, and January, 1984, to provide a minimum follow-up of 6 months. Follow-up has been 100% for a total of 1,619 patient-years, with a mean follow-up of 2 1/2 years. There were 41 late deaths (6.1%): 30 in the aortic group, eight in the mitral group, and three in the double valve replacement group. Fourteen (34.2%) of these late deaths have been considered valve-related. At 5 1/2 years, the actuarial survival rate, hospital mortality excluded, is 91% for aortic, 90% for mitral, and 95% for double valve replacement. Functional improvement of these patients is quite satisfactory: Preoperatively, 60.3% were in Class III or IV of the New York Heart Association, whereas postoperatively, 99.5% of the patients are in Class I or II. As 78 patients (65 aortic, 10 mitral, and three double valve replacement) did not receive anticoagulation therapy for a total period of 84 patient-years, the incidence of valve thrombosis, systemic embolism, and sudden or suspicious deaths in this group was compared with that in a group of 630 patients (including 60 patients from the first group who were given anticoagulants afterwards) subjected to long-term anticoagulation for a total period of 1,535 patient-years. A significantly higher incidence of valve thrombosis and systemic embolism was observed in the absence of anticoagulation. Anticoagulant-related complications occurred in 10 patients, with an incidence of 0.65/100 patient-years. On the basis of this 5 1/2 years of experience, the St. Jude Medical valve appears to be an excellent mechanical prosthesis for cardiac valve replacement, in terms of hemodynamic performance and low thrombogenicity, in patients receiving anticoagulants.     

Acute mechanical valve thrombosis of the St. Jude medical prosthesis

From 1986 to 1996, 2585 patients underwent valve replacement with the St. Jude medical prosthesis. Sixty experienced mechanical valve thrombosis. Seventeen of 60 patients (28.3%) had isolated aortic valve replacements, 33 had isolated mitral valve replacements (55%), and 10 had double valve replacements (16.7%) (aortic and mitral valve replacement). All patients who underwent reoperation for mechanical valve thrombosis were functional Class III or IV. Against medical advice, systemic anticoagulation with warfarin sodium had been discontinued or used only intermittently. Thus, anticoagulant activity was not adequate. The diagnosis of thrombosis was made by clinical examination, laboratory findings, and echocardiography and cineradiography. Of the 60 patients, 9 patients died early after surgery or before discharge. Most of the deaths were attributed to low cardiac output. The overall hospital mortality was 15%. The overall 10-year actuarial survival rate was 82.8+/-1.6%. In our study, reoperation for thrombosed mechanical prosthesis was not an independent parameter determining mortality. Age was the only statistically important hospital mortality predictor. Of this group, 90% suffered mechanical valve obstruction within the first 5 years after operation. These results suggest that valve re-replacement appears to be a suitable surgical treatment for thrombosis of mechanical prosthetic valves, especially in the young. In these patients subsequent anticoagulation management is necessary.     

Eight year experience with the CarboMedics bileaflet valvular prosthesis.

Two hundred and two patients (97 female and 105 male; mean age: 45. 5+/-9 years) received CarboMedics bileaflet valves during a period of eight years. Ninety-one patients received mitral, 72 aortic and 39 aortic+mitral valve prosthesis. Tricuspid plasty and coronary artery bypass surgery were the concomitant operations in 17 and 12 patients, respectively. The mean follow-up period was 24.7 months and the ratio was 91%. Overall operative mortality was 3.96% (8 patients); 2.78% for aortic valve replacement (AVR), 3.29% for mitral valve replacement (MVR) and 7.7% for double valve replacement (DVR). The late mortality rate was 2.89% for AVR, 2.2% for MVR and 8. 3% for DVR. The main cause of mortality was low cardiac output. The overall survival rate was 91.5% in 2 years. The actuarial freedom from thromboembolism in 2 years was 97% for AVR, 95% for MVR and 84% for DVR. No mortality due to heamorrhagic events was observed. CarboMedics prosthetic heart valves may be used satisfactorily with a low incidence of valve-related morbidity and mortality.     

4437例瓣膜置换术住院死亡危险因素分析及安贞风险评分系统建立

目的 对4437例心脏瓣膜置换于术病人进行同顺性研究,定量评估住院死亡的危险因素,建立瓣膜置换手术住院死亡风险模型,以及安贞医院瓣膜置换手术风险评分系统.方法 选取安贞医院心脏外科数据库中收录的主动脉瓣置换术病人848例,二尖瓣置换术病人2202例,主动脉瓣、二尖瓣舣瓣膜置换术病人1387例.选取术前.术中33个临床指标作为住院死亡的可能影响因素,利用单因素分析进行筛选,然后利用多因素分析确立3种手术的住院死亡危险因素并建立风险模型.结果经多因素分析,年龄、体表面积、心功能分级、术前肌酐和体外循环时间是主动脉瓣置换术住院死亡的危险因素.心功能分级、术前心衰史、心胸比率、短轴缩短率、病因、左心室收缩末径,体外循环时间和术中1ABP是二尖瓣置换术住院死亡的危险因素.年龄、心功能分级、术前心内膜炎、糖尿病史、既往二尖瓣球囊扩张术,体重指数和体外循环时间是丰动脉瓣、二尖瓣双瓣膜置换术的住院死亡危险因素.ROC曲线下面积分别为主动脉瓣置换术模型0.921(95%CI,0.874～0.967),二尖瓣置换术模型0.859(95%C1,0.813～0.905),主动脉瓣、二尖瓣舣瓣膜置换术模型0.868(95%CI,0.827～0.908).Hosmer-Leme-show检验显示,主动脉瓣置换术模型χ~2=1.463,P=0.993,二尖瓣置换术模型χ~2=8.720,P=0.366,主动脉瓣、二尖瓣双瓣膜置换术模型χ~2=8.134,P=0.420,预计病死率与实际观测病死率差异无统计学意义.结论 3个模型能够定定量评估瓣膜置换术病人住院死亡风险.     

The Hancock pericardial xenograft: incidence of early mechanical failures at a medium-term follow-up

The Hancock pericardial xenograft has been used in our Institution since August 1981 as an alternative to porcine bioprostheses. Up to July 1984, 97 Hancock pericardial xenografts have been implanted in 84 patients; of 76 operative survivors with a mean age of 55.2±13 years (range 13–75 years), 50 had undergone aortic valve replacement, 16 mitral valve replacement and 10 mitral-aortic valve replacement. Follow-up ranged from 0.5 to 5.2 years with a cumulative duration of 239 patient/years and is 99% complete. Actuarial survival is 92%±4% for patients with aortic valve replacement and 84%±10% for patients with mitral valve replacement at 5 years, and 77%±14% for those with mitral-aortic valve replacement at 4 years. Thromboembolic episodes occurred in 2 patients (1 after aortic and 1 after mitral valve replacement). The actuarial freedom from emboli is 100% for patients with mitral-aortic valve replacement at 4 years, and 96%±3% for patients with aortic and 93%±6% for patients with mitral valve replacement at 5 years. Reoperation was performed in 13 patients (9 aortic, 2 mitral and 2 mitral-aortic valve replacements), because of endocarditis in 3 (2 aortic and 1 mitral valve replacement), paravalvular leak in 1 (aortic valve replacement), and primary tissue failure in 9 (6 aortic, 1 mitral and 2 mitral-aortic valve replacements). Actuarial freedom from primary tissue failure is 72%±9% for aortic and 83%±8% for mitral Hancock pericardial xenografts at 5 years. Eleven xenografts explanted because of primary tissue failure were studied pathologically. All showed commissural tears with gross regurgitation; calcium deposits were severe in 2, mild but unrelated to the tears in 2 and absent in 7. Collagen disarray was observed at the site of cusp rupture while the collagen was well preserved in the intact areas of the leaflets. Our results show that: 1) Hancock pericardial xenografts have a high rate of early primary tissue failure, 2) primary tissue failure is caused by cusp rupture at the commissures and can be considered fatigue-induced, 3) tissue calcification does not influence the durability of pericardial xenografts which do not represent a valid alternative to porcine bioprostheses.     

Valve-related complications with the Hancock I porcine bioprosthesis. A twelve- to fourteen-year follow-up study

Valve-related morbidity and mortality after heart valve replacement with the Hancock I porcine bioprosthesis has been retrospectively analyzed. From June 1974 through December 1976, 253 Hancock I bioprostheses (150 mitral and 103 aortic) were inserted in 220 selected patients who survived the operation and had follow-up until June 1989 (mean follow-up 13.5 years, with an accumulative follow-up of 2956.4 patient-years). One hundred seventeen patients had mitral valve replacement, 70 had aortic valve replacement, and 33 had combined mitral and aortic valve replacement. There were 27 thromboembolic events. The probability of being free from thromboembolism at 14 years was 81.0% +/- 7.4% for the mitral valve replacement group, 85.4% +/- 6.7% for the aortic group, and 67.1% +/- 18.4% for the mitral-aortic group. Fifteen episodes of prosthetic valve endocarditis occurred. There were 10 instances of nonstructural dysfunction (paravalvular leaks) in seven mitral valves (4.6%) and in three aortic valves (2.9%). One hundred twenty-two bioprostheses in 106 patients resulted in structural deterioration. The probability of freedom from structural deterioration at 14 years was 37.2% +/- 3.9% for the mitral group, 43.9% +/- 7.1% for the aortic group, and 30.1% +/- 8.9% for the mitral-aortic group. The logistic regression analysis between age at the time of operation and bioprosthetic life (structural deterioration-free period) demonstrates a linear regression curve (r = 0.53). There were 56 late deaths (27 patients died at reoperation). The actuarial survival rate (including hospital mortality) at 14 years was 57.2% +/- 5.4% for the entire series, with no statistically significant difference between groups. The probability of remaining free from valve-related morbidity and mortality at 14 years was 16.7% +/- 4.8% for the mitral group, 20.8% +/- 6.2% for the aortic group, and 14.0% +/- 7.0% for the mitral-aortic group. The long-term results of this series show that the clinical performance of the Hancock I porcine valve appears satisfactory during the first 6 years. The behavior of this bioprosthesis at 14 years' follow-up changes drastically, because only a minor group of patients is free from valve-related complications, justifying the restriction of its use for selected patients.