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.     

Redo aortic root replacement: experience with 31 patients

BACKGROUND: Aortic root re-replacement is being performed with increased frequency. Limited information is available regarding the surgical approaches and clinical outcomes of this reoperation. METHODS: Between May 1980 and May 1999, 31 patients (mean age, 45 +/- 15 years) underwent redo composite replacement of the aortic valve and ascending aorta. Indications for reoperation were prosthetic valve endocarditis in 12 patients (39%), failed biological valve in 17 (55%), and false aneurysm in 2 (6%). At reoperation, mechanical valves were implanted in 24 patients and biologic valves in 7. All patients with endocarditis had annular abscess and required reconstruction of the left ventricular outflow tract before implantation of a new valved conduit. Mechanical valves were used in 24 patients, aortic homograft in 4, and bioprosthetic valves in 3. The coronary button technique was used to reimplant the coronary arteries whenever possible. Extension of one or both coronary arteries with a short segment of saphenous vein or a synthetic graft was used in 16 patients (52%). The aortic arch was replaced in 7 patients (23%). RESULTS: There was one operative death (3%) because of rupture of an abdominal aortic aneurysm. The mean follow-up was 47 +/- 46 months and was 100% complete. There were five late deaths (16%), three of which were cardiac related. The actuarial survival was 71% +/- 12% at 5 years. Three patients experienced recurrent prosthetic valve endocarditis 4 months to 8 years after operation. The 8-year freedom from endocarditis for patients operated on for endocarditis was 82% +/- 11% compared with 100% for those operated on for other reasons (p = 0.1). At the last follow-up, 21 of 25 survivors (84%) were in New York Heart Association functional classes I or II, and 4 were in class III. CONCLUSIONS: Redo aortic root replacement can be performed with good early and late results. Patients operated on for prosthetic root endocarditis may have an increased risk of recurrent late endocarditis.     

Survival and valve failure after aortic valve replacement.

A prospective evaluation of 412 consecutive patients undergoing isolated aortic valve replacement between January 1982 and December 1985 was performed in an attempt to identify the determinants of survival and valve failure. A variety of valves were inserted to permit a prospective evaluation of alternative valves including: Bj?rk-Shiley mechanical (n = 37), Ionescu-Shiley pericardial (n = 261), Hancock pericardial (n = 78), and Carpentier-Edwards porcine (n = 36). Thirteen patients died in the hospital (3.2%) and 47 patients died in the follow-up period producing an actuarial survival of 81% +/- 3% at 48 months. Survival was independently predicted by advancing age, preoperative New York Heart Association functional class, and the presence of endocarditis (p less than 0.05 by Cox regression analysis). The majority of patients were symptomatically improved (New York Heart Association class I or II: 21% preoperative, 88% postoperative). Freedom from structural valve dysfunction, prosthetic valve endocarditis, and reoperation for valve-related complications were 95% +/- 2%, 95% +/- 2%, and 92% +/- 2% at 48 months, respectively. These valve-related complications occurred more frequently in younger patients and in those with a Hancock pericardial valve (freedom from structural valve dysfunction, 89% +/- 5%; prosthetic valve endocarditis, 84% +/- 9%; reoperation, 78% +/- 10%; p less than 0.05 by Cox regression). Freedom from thromboembolism was 88% +/- 2% at 48 months; it was significantly lower in patients with a preoperative thromboembolic event and was not influenced by the type of prosthesis inserted. Freedom from anticoagulant-related hemorrhage was 85% +/- 8% at 48 months and was not influenced by any preoperative factors.(ABSTRACT TRUNCATED AT 250 WORDS)     

Surgical treatment of paravalvular abscess: long-term results.

OBJECTIVE: To examine the outcomes of surgery for active infective endocarditis with paravalvular abscess. METHODS: Paravalvular abscess was defined as infective necrosis of the valve annulus that required patch reconstruction before implanting a new valve. Of 383 patients with active infective endocarditis who underwent surgical treatment, 135 (35%) had paravalvular abscess. Patients' mean age was 51+/-16 years and 68% were men. The infected valve was native in 69 patients and prosthetic in 66. The abscess involved the aortic annulus in 73 patients, the mitral annulus in 27, the aortic and mitral annuluses in 33, and the aortic and tricuspid and/or pulmonary annuluses in 2. Surgery consisted of radical resection of the abscess, reconstruction of the annulus with patches and valve replacement. Mean follow-up was 6.2+/-5.2 years and complete. RESULTS: There were 21 (15.5%) operative deaths. Preoperative shock and abscess in the aortic and mitral annuluses were independent predictors of operative death. There were 34 (25%) late deaths. Survival at 15 years was 43+/-6% for all patients, 50+/-8% for native valve endocarditis and 35+/-9% for prosthetic (p=0.41). Age by increments of 5 years and recurrent endocarditis were independent predictors of late death. There were 16 episodes of recurrent endocarditis in 15 patients, and the freedom from recurrent endocarditis was 82+/-4% at 15 years. Fifteen reoperations were performed in 14 patients. Freedom from reoperation was 72+/-9% at 15 years. CONCLUSIONS: Surgery for active endocarditis with paravalvular abscess was associated with high operative mortality, particularly in patients in shock and abscess of both mitral and aortic annuluses. Long-term survival was adversely affected by age and recurrent bouts of endocarditis.     

Immediate and long-term results of valve replacement for native and prosthetic valve endocarditis

BACKGROUND: The objective of the present study was to compare current results of prosthetic valve replacement following acute infective native valve endocarditis (NVE) with that of prosthetic valve endocarditis (PVE). Prosthetic valve replacement is often necessary for acute infective endocarditis. Although valve repair and homografts have been associated with excellent outcome, homograft availability and the importance of valvular destruction often dictate prosthetic valve replacement in patients with acute bacterial endocarditis. METHODS: A retrospective analysis of the experience with prosthetic valve replacement following acute NVE and PVE between 1988 and 1998 was performed at the Montreal Heart Institute. RESULTS: Seventy-seven patients (57 men and 20 women, mean age 48 +/- 16 years) with acute infective endocarditis underwent valve replacement. Fifty patients had NVE and 27 had PVE. Four patients (8%) with NVE died within 30 days of operation and there were no hospital deaths in patients with PVE. Survival at 1, 5, and 7 years averaged 80% +/- 6%, 76% +/- 6%, and 76% +/- 6% for NVE and 70% +/- 9%, 59% +/- 10%, and 55% +/- 10% for PVE, respectively (p = 0.15). Reoperation-free survival at 1, 5, and 7 years averaged 80% +/- 6%, 76% +/- 6%, and 76% +/- 6% for NVE and 45% +/- 10%, 40% +/- 10%, and 36% +/- 9% for PVE (p = 0.003). Five-year survival for NVE averaged 75% +/- 9% following aortic valve replacement and 79% +/- 9% following mitral valve replacement. Five-year survival for PVE averaged 66% +/- 12% following aortic valve replacement and 43% +/- 19% following mitral valve replacement (p = 0.75). Nine patients underwent reoperation during follow-up: indications were prosthesis infection in 4 patients (3 mitral, 1 aortic), dehiscence of mitral prosthesis in 3, and dehiscence of aortic prosthesis in 2. CONCLUSIONS: Prosthetic valve replacement for NVE resulted in good long-term patient survival with a minimal risk of reoperation compared with patients who underwent valve replacement for PVE. In patients with PVE, those who needed reoperation had recurrent endocarditis or noninfectious periprosthetic dehiscence.     

Aortic valve replacement for active infectious endocarditis in 108 patients. A comparison of freehand allograft valves with mechanical prostheses and bioprostheses.

A total of 108 patients hospitalized with active (acute) endocarditis on either a native aortic valve (n = 66) or a previously inserted replacement device (n = 42) underwent aortic valve replacement because they were too ill for hospital discharge. A nonstented aortic allograft valve was used in 78 patients and prosthetic (mechanical or bioprosthetic) valves in 30 patients. The survival rate was 82% at 1 months, 73% at 1 year, 64% at 5 years, and 36% at 15 years. It was better in patients with native valve endocarditis than prosthetic valve endocarditis. The incremental risk factors for death in the early phase postoperatively were older age at operation, higher New York Heart Association functional class, and a larger number of previous aortic valve procedures. There were 13 episodes of recurrent endocarditis, giving an actuarial freedom of 80% at 10 years. The hazard function for recurrent endocarditis had only a low constant phase when allograft valves were used, which contrasted with the existence of a high peaking early phase (in addition to the constant phase) when prosthetic devices were used. No risk factors for recurrent endocarditis were found in patients receiving a prosthesis, and "localized" versus "extensive" endocarditis was the only risk factor when an allograft was used. Reoperation was performed in 24 patients for a variety of reasons, and freedom from reoperation was 61% at 10 years. It is concluded that the allograft valve is the valve of choice when aortic valve replacement is required for active endocarditis.     

Prosthetic replacement of tricuspid valve: bioprosthetic or mechanical

BACKGROUND: Tricuspid valve replacement is one of the most challenging operations in cardiac surgery. Selection of the suitable prosthesis is still debatable. METHODS: In our institution, between January 1980 and December 2000, 129 tricuspid valve replacements were performed in 122 patients (14.7%). Bioprosthetic valves were used in 32 patients, whereas 97 patients had mechanical valve implantation. Twenty-two percent of replacements were done on men. Mean age was 35.27+/-11.56 years. In all patients, initially an annuloplasty technique was tried. Tricuspid valve replacement was performed when annuloplasty was not sufficient. In most of the cases, tricuspid valve interventions were done under cardiopulmonary bypass and on a beating heart. RESULTS: Early mortality was 24.5%. Patients were followed for 2 to 228 months. Seven patients underwent reoperation because of tricuspid valve dysfunction (7.6%). Nine patients died during the follow-up period. Late mortality was 9.7%. Actuarial estimates of survival in 20 years of follow-up for all tricuspid prosthetic valves, mechanical valves, and bioprosthetic valves were 65.1%+/-9.3%, 68.3%+/-10.6%, and 54.8%+/-12.1%, respectively. For the bioprosthetic valve group, freedom from structural valve degeneration was 90%+/-5.5%; for the mechanical valve group, freedom from deterioration, endocarditis, and leakage was 97.8%+/-4.2%, and freedom from thromboembolism was 92.6%+/-6.9%. CONCLUSIONS: We found that there was no statistically significant difference between the two groups in terms of early mortality, re-replacement, and midterm mortality (p > 0.05). Nevertheless, we recommend low profile modern bileaflet mechanical valves for prosthetic replacement of the tricuspid valve, due to their favorable hemodynamic characteristics and durability.     

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.     

Comparison of bioprosthetic and mechanical valve replacement for active endocarditis

The choice between bioprosthetic or mechanical prosthetic valve replacement for active valvular endocarditis has been controversial. To establish the role of each, we reviewed the case histories of 185 patients who underwent valve replacement for active valvular endocarditis during the past 5 years. All patients had life-threatening, active bacterial endocarditis of a native or prosthetic valve. Group I (88 patients) had replacement with the Ionescu-Shiley pericardial valve and Group II (97 patients) with the St. Jude Medical valve. The male/female distribution, age range, and functional classification were the same in the two groups. Mean follow-up was approximately 20 months for both groups. Valve replacement was done because of native valve endocarditis in 76 patients in Group I and 49 patients in Group II. Of the remainder of the Group I patients, six had endocarditis of a bioprosthesis and six of a mechanical valve; of the remainder of Group II patients, 30 had endocarditis of a bioprosthesis and 18 of a mechanical valve. Early mortality was not significantly different between the two groups (14 deaths in each group). Of the 74 survivors in Group I, 15 underwent valve reoperation, 10 because of recurrent endocarditis and five because of sterile perivalvular leakage. The frequency of reoperation was significantly different (p less than 0.01) from that in Group II, in which only five patients underwent valve reoperation, four for recurrent endocarditis and one for sterile perivalvular leakage. The actuarial rate for freedom from reoperation was also significantly higher in Group II patients; 94.6% were free from reoperation at 4 years compared to 75% at 4 years in Group I patients (p less than 0.01). The actuarial survival rate, which also differed significantly between groups, was 78.7% at 4 years in Group I and 87.4% at 4 years in Group II (p less than 0.05). Patients receiving a bioprosthesis for active endocarditis had a significantly higher reoperation rate and a significantly greater incidence of recurrent endocarditis (p less than 0.01). Therefore, we prefer to use a mechanical valve for valve replacement in most patients who have active endocarditis.     

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.     

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.     

Fifteen-year clinical experience with the biocor porcine bioprostheses in the mitral position

BACKGROUND: Bioprosthetic valve use represents a crucial improvement in surgical treatment of mitral valve disease. The aim of this study is to determine the long-term durability of the Biocor porcine bioprosthetic mitral valve. METHODS: Between 1985 and 1989, a total of 158 Biocor porcine bioprosthetic valves were placed in the mitral position, and long-term results of these patients were investigated retrospectively in 1999. RESULTS: Thirty-day mortality was 4.4% (7 patients). Total follow-up was 1,499 patient-years. Actuarial survival was 83.66% +/- 3% at 5 years, 77.78% +/- 3.36% at 13 years (1.8% patient-year). Multivariate analysis demonstrated younger age, duration of implantation, congestive heart failure, and functional class to be significant predictors of late mortality. Actuarial freedom from valve-related mortality was 98.58% +/- 1% at 15 years (0.13% patient-year). Actuarial freedom from structural valve deterioration was 95.49% +/- 1.8% at 5 years, 70.2% +/- 4.12% at 10 years, and 64.82% +/- 5.34% at 13 years (2.6% patient-year). Actuarial freedom from structural valve deterioration-related reoperation was 98.43% +/- 1.1% at 5 years, 89.15% +/- 2.85% at 10 years, and 76.82% +/- 7.91% at 14 years. Multivariate analysis showed younger age and duration of implantation to be significant predictors of structural valve deterioration and its related reoperation. CONCLUSIONS: By studying a 15-year time period, it is seen that this new generation porcine bioprosthetic valve should be considered an alternative for mechanical valves in selected patients.     

Early and late outcomes after reoperation for prosthetic valve endocarditis

OBJECTIVE: Prosthetic valve endocarditis remains a challenging complication after heart valve replacement. To identify predictive risk factors, we have reviewed 30 patients who underwent surgery for prosthetic valve endocarditis between March 1986 and May 1999. METHODS: There were 15 men and 15 women (mean age 51 years). Prosthetic valve endocarditis was classified as early (< or = 1 year after operation) in 10 cases, and as late in the other 20 cases. The most common indication for surgery was moderate to severe congestive heart failure due to prosthetic valve dysfunction in 21 (70%) patients. The average follow-up period was 6.5 years, with a range of 0.3 to 14.1 years. RESULTS: The most common microorganism was Staphylococcus epidermidis in both patients with early (50%) and late prosthetic valve endocarditis (25%). The in-hospital mortality was 13.3% (4/30). There were six late deaths. The actuarial survival at 5 years was 78% and 66% at 10 years. An early onset of prosthetic valve endocarditis was the only significant determinant of both in-hospital mortality (p = 0.005) and overall mortality (p = 0.021). Emergency surgery had a statistically significant relationship with in-hospital mortality (p = 0.045). No significant influence on mortality after reoperation for prosthetic valve endocarditis was found in age, sex, valve position, antecedent native valve endocarditis, or in the type of pathological findings (ring abscess, valve dehiscence, and vegetation). CONCLUSION: Early onset of prosthetic valve endocarditis and emergency surgery were important risk factors for mortality due to prosthetic valve endocarditis.     

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.     

Durability and outcome of aortic valve replacement with mitral valve repair versus double valve replacement

BACKGROUND: The purpose of this study was to evaluate morbidity and mortality after double valve replacement (DVR) and aortic valve replacement with mitral valve repair (AVR + MVP). METHODS: From 1977 to 2000, 379 patients underwent DVR (n = 299) or AVR + MVP (n = 80). Actuarial survival and freedom from reoperation were determined by the Kaplan-Meier method. Potential predictors of mortality and reoperation were entered into a Cox multiple regression model. Propensity score was introduced for the multivariable regression modeling for adjustment of a selection bias. RESULTS: Survival 15 years after surgery was similar between the groups (DVR, 81% +/- 3%; AVR + MVP, 79% +/- 7%; p = 0.44). Freedom from thromboembolic event at 15 years was similar between the groups (p = 0.25). Freedom from mitral valve reoperation at 15 years was significantly better for the DVR group (54% +/- 5%) as compared with the AVR + MVP group (15% +/- 6%; p = 0.0006), primarily due to progression of mitral valve pathology and early structural deterioration of bioprosthetic aortic valve used for patients with AVR + MVP. After AVR + MVP, freedom from mitral reoperation at 15 years was 63% +/- 16% for nonrheumatic heart diseases, and 5% +/- 5% for rheumatic disease (p = 0.04). CONCLUSIONS: Although both DVR and AVR + MVP provided excellent survival, DVR with mechanical valves should be the procedure of choice for the majority of patients because of lower incidence of valve failure and similar rate of thromboembolic complications compared with AVR + MVP. MVP should not be performed in patients with rheumatic disease because of higher incidence of late failure.     

Use of stentless xenografts in the aortic position: determinants of early and late outcome

BACKGROUND: Whether to perform a stentless aortic valve replacement (AVR) is not well established. Our aim was to determine the outcome after AVR with stentless xenograft valves. METHODS: Between 1996 and 2001, a total of 404 patients (mean age 70.4 years) underwent a stentless AVR by one surgeon in our unit. Concomitant procedures were performed in 132 patients (33%). Twenty patients (6.4%) had undergone previous AVR. Eleven types of stentless xenograft valves were implanted: Medtronic Freestyle in 221 patients (55%), Shelhigh in 55 (14%), Shelhigh composite conduit in 33 (8%), Sorin in 26 (6%), Cryolife O'Brien in 25 (6%), Aortech-Elan in 17 (4%), Edwards Prima in 14 (4%), Toronto SPV in 7 (2%), and other valves in 6 (1%). A subcoronary implantation technique was used in 302 cases (76%), complete root replacement in 62 (15%), and a modified Bentall-De Bono procedure in 33 (8%). Mean follow-up was 19.4 months (range, 1.2 to 60.6 months). RESULTS: Overall hospital mortality was 4.2%. This was 2.4% for isolated AVR, 3.6% for AVR and coronary artery bypass grafting, 5.5% for replacement of two or more valves, and 12% for the modified Bentall procedure. On multiple logistic regression redo cardiac operation (p = 0.0006), cardiogenic shock (p = 0.001), left ventricular ejection fraction less than 0.30 (p = 0.01), modified Bentall procedure (p = 0.03), and endocarditis (p = 0.04) were predictors of in-hospital death. Five-year freedom from thromboembolism, hemorrhage, prosthetic endocarditis, structural valve deterioration, and reoperation was 97%, 99%, 99%, 98%, and 96%, respectively. Kaplan-Meier survival at 5 years was 88%. On Cox regression, cardiogenic shock (p = 0.001) and older age (p = 0.03) were adverse predictors of survival. At echocardiographic examination within 6 months from the operation, mean aortic valve gradients were 15 +/- 6 mm Hg, 12.8 +/- 3 mm Hg, 10.8 +/- 4 mm Hg, 9.3 +/- 3 mm Hg, 9.1 +/- 4 mm Hg, and 8.2 +/- 3 mm Hg for valve sizes of 19, 21, 23, 25, 27, and 29 mm, respectively. CONCLUSIONS: The availability of several stentless valve designs facilitates the surgical treatment of diverse aortic valve or root diseases with encouraging early and mid-term results. Patients requiring concomitant procedures may also benefit from the excellent hemodynamic characteristics of a stentless valve. We consider stentless AVR the treatment of choice for patients older than 60 years and those having small aortic roots.     

The Mitroflow pericardial bioprosthesis. Comparison of early clinical performance in aortic and mitral positions.

Between 1983 and 1987 the Mitroflow pericardial prosthesis was implanted in 354 patients, ranging in age from 14 to 94 years (mean 60.1 years). The early mortality was 5.7% and the late mortality 2.9% per patient-year. The total cumulative follow-up was 853 years (mean 2.4 years). Patient survival at 4 years for aortic valve replacement (AVR) was 81.5% and for mitral valve replacement (MVR) 74.8%. The overall rate of valve-related complications was 4.8% per patient-year (41 complications): thromboembolism, 15; hemorrhage related to antithromboembolic therapy, 1; prosthetic valve endocarditis, 15; nonstructural dysfunction, 3; and structural valve deterioration, 7. At 4 years the freedom from thromboembolism was 91.5% +/- 2.7% for AVR and 91.1% +/- 4.0% for MVR, from prosthetic valve endocarditis 93.5% +/- 2.3% for AVR and 94.0% +/- 2.9% for MVR, from structural valve deterioration 97.3% +/- 2.1% for AVR and 92.6% +/- 3.2% for MVR, from valve-related mortality 96.9% +/- 1.4% for AVR and 97.5% +/- 1.8% for MVR, and from reoperation 93.5% +/- 2.8% for AVR and 83.1% +/- 5.1% for MVR. The freedom from the composite of all valve-related complications at 4 years was 81.1% +/- 4.2% for AVR and 75.3% +/- 2.8% for MVR. The Mitroflow valve has provided satisfactory clinical performance at the 4-year evaluation. Structural valve deterioration is greater in the mitral position than in the aortic position. Long-term evaluation of the Mitroflow valve is necessary to determine the impact of structural valve deterioration on its clinical performance.     

Long-term durability of the Hancock II porcine bioprosthesis

BACKGROUND: Survival and prosthetic complications of patients receiving the Hancock II second-generation bioprosthesis (Medtronic, Inc, Minneapolis, Minn) in the aortic, mitral, mitral-aortic, and tricuspid positions were analyzed at 15 years' follow-up. METHODS: Between May 1983 and December 1993, 212 patients (104 men and 108 women; mean age, 63 +/- 9 years; age range, 29-81 years) received 66 aortic, 114 mitral, 26 mitral-aortic, and 6 tricuspid Hancock II valves. Thirty-one percent of patients had previous valve operations, 15% had concomitant cardiac procedures, and 87% were in New York Heart Association class III or IV. Follow-up included 1704 patient-years and was 98% complete, with a median of 9 patient-years (range, 0.013-17.4 years). Forty-six patients were at risk at 14 to 15 years, and 30 were at risk after 15 years. RESULTS: One hundred twenty-two (57%) of 212 patients died, 20 of them perioperatively. Fifteen-year actuarial Kaplan-Meier survival was 35.2% +/- 3.8%, and freedom from valve-related mortality was 84% +/- 3.5%, with no difference on the basis of position or age (<65 or >or=65 years). Percentages for freedom from thromboembolism, anticoagulant-related hemorrhage, endocarditis, and paravalvular leak were, respectively, 78.2% +/- 4%, 83.5% +/- 3.6%, 95.7% +/- 2%, and 97.3% +/- 1.4%, with no significant difference between the aortic and mitral positions. Freedom from structural valve deterioration was 71.8% +/- 5.6%: 88.9% +/- 6.2% in the aortic position versus 59.5% +/- 3.9% in the mitral position (P =.01) and 64.3% +/- 3% in the mitral-aortic position. In patients younger than 65 years, actual freedom from structural valve deterioration was less than that seen in older patients (84.5% +/- 3.5% vs 95% +/- 3.0%) and was better in the aortic versus the mitral position (92% +/- 4.5% vs 82% +/- 4.2%). CONCLUSION: The Hancock II porcine valve showed excellent 15-year durability. We recommend its use in patients 65 years of age, as well as in younger patients undergoing aortic replacement.     

Ten-year experience with the porcine bioprosthetic valve: interrelationship of valve survival and patient survival in 1,050 valve replacements

The porcine bioprosthetic valve was used in 440 patients having isolated mitral valve replacement (MVR), 522 patients having isolated aortic valve replacement (AVR), and 88 patients having MVR + AVR between 1974 and 1981. Patients with associated surgical procedures were excluded. Mean follow-up was 8.3 years. At 10 years, there was no difference in patient survival between those having AVR and those having MVR. Reoperations were performed on 192 patients. Endocarditis was the reason for reoperation in 3.7% of patients who had MVR and 10.6% of those who had AVR. Structural valve degeneration was the reason for reoperation in 89.7% of MVR patients and 78.8% of AVR patients (p = 0.04). Hospital mortality among patients having valve reoperations was 4.7%. At 10 years, the freedom from valve reoperation for all causes and from structural valve degeneration was significantly better for the AVR group than the MVR group (74% +/- 3% versus 61% +/- 4%, p = 0.004; and 79% +/- 3% versus 63% +/- 4%, p = 0.0006, respectively). For patients in their 60s, the 10-year freedom from reoperation was 92% +/- 2% for AVR and 80% +/- 6% for MVR (p = not significant). At 10 years, freedom from cardiac-related death and valve reoperation was best for both MVR and AVR patients in their 60s. Patients 70 years old or older rarely had reoperation but died before valve failure occurred. The 10-year freedom from all major valve-related events (cardiac-related death, reoperation, thromboembolism, endocarditis, and anticoagulant-related bleeding) was practically the same for both MVR and AVR patients (48% +/- 3% versus 49% +/- 3%, respectively). The porcine bioprosthetic valve is the valve of choice only for patients 60 years old or older. Patients in their 70s have an extremely low rate of reoperation but a high rate of cardiac-related death and do not outlive the prostheses.     

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.