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.     

Results of reoperation for primary tissue failure of porcine bioprostheses

Results of reoperation for primary tissue failure of porcine bioprostheses were evaluated in 574 patients discharged from the hospital from 1970 to 1981. A total of 413 had undergone isolated mitral valve replacement and 161 isolated aortic valve replacement. Through March, 1984, 88 patients (15%) had required reoperation: 59 had undergone mitral and 29, aortic valve replacement. Primary tissue failure was the main cause of bioprosthetic dysfunction; it occurred in 64 patients (46 mitral and 18 aortic) at a mean postoperative interval of 93 +/- 4 months (range 34 to 158). During the same period, 11 patients required reoperation for bioprosthetic endocarditis, 11 for paravalvular leak, and two for thrombosis. These patients are not included in this review. Reoperation for primary tissue failure was performed after a mean interval of 72 +/- 6 months (range 38 to 158) for patients with aortic bioprostheses and after 101 +/- 5 months (range 34 to 153) for those with mitral bioprostheses (p less than 0.05). Overall mortality at reoperation was 12.5%: 11% for the mitral group and 16% for the aortic group. In 62 patients (45 mitral and 17 aortic) primary tissue failure was caused by calcification of the cusps, associated with severe fibrous tissue overgrowth in seven. Bioprosthetic failure was caused by an intracuspal hematoma in one patient with mitral valve replacement and by lipid infiltration of the cusps in one patient with aortic valve replacement. Actuarial freedom from bioprosthetic primary tissue failure at 12 years is 61% +/- 5% for the mitral group and 69% +/- 7% for the aortic group. On the basis of our long-term follow-up of patients after mitral or aortic replacement with a porcine bioprosthesis, we conclude: primary tissue failure is the most frequent indication for reoperation in patients with a porcine bioprosthesis; calcification of the cusp tissue is the leading cause of primary tissue failure; reoperation for primary tissue failure may be a major concern, although mortality for elective cases is low; and the limited durability of porcine bioprostheses suggests their use be restricted to selected patients.     

Mechanical versus bioprosthetic valve replacement in middle-aged patients.

OBJECTIVE: The current trend towards decreasing the age for selection of a tissue over a mechanical prosthesis has led to a dilemma for patients aged 50-65 years. This cohort study examines the long-term outcomes of mechanical versus bioprosthetic valves in middle-aged patients. METHODS: Patients (N = 659) aged between 50 and 65 years who had first-time aortic valve replacement (AVR) and/or mitral valve replacement (MVR) with contemporary prostheses were followed prospectively after surgery. The total follow-up was 3,402 patient-years (mean 5.1 +/- 4.1 years; maximum 18.3 years). Outcomes were examined with multivariate actuarial methods. A composite outcome of major adverse prosthesis-related events (MAPE) was defined as the occurrence of reoperation, endocarditis, major bleeding, or thromboembolism. RESULTS: Ten-year survival was 73.2 +/- 4.2% after mechanical AVR, 75.1 +/- 12.6% after bioprosthetic AVR, 74.1 +/- 4.6% after mechanical MVR, and 77.9 +/- 7.4% after bioprosthetic MVR (P=NS). Ten-year reoperation rates were 35.4% and 21.3% with aortic and mitral bioprostheses, respectively. Major bleeding occurred more often following mechanical MVR (hazard ratio [HR]: 3.3; 95% confidence interval [CI] 1.2, 9.0; P = 0.022), and the incidence of any thromboembolic event was more common after mechanical MVR (HR: 4.7; CI 1.4, 13.3; P = 0.01). Overall freedom from MAPE at 10 years was 70.2 +/- 4.1% for mechanical AVR patients, 41.0+/-30.3% for bioprosthetic AVR patients, 53.3 +/- 8.8% for mechanical MVR patients, and 61.2 +/- 9.2% for bioprosthetic MVR patients. Although a trend existed towards more MAPE amongst middle-age patients with tissue valves, multivariate analysis did not identify the presence of a bioprosthesis as an independent risk factor for MAPE (HR: 1.3; CI 0.9, 2.0; P = 0.22). CONCLUSIONS: In middle-aged patients, MAPE may occur more often in patients with bioprosthetic valves, but definitive conclusions necessitate the accumulation of additional follow-up. At present, these data do not support lowering the usual cutoff for implantation of a tissue valve below the age of 65.     

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.     

Reoperative surgery for degenerated aortic bioprostheses: predictors for emergency surgery and reoperative mortality.

OBJECTIVE: The long-term outcome of patients with aortic bioprosthetic valves could be improved by decreasing the reoperative mortality rate. METHODS: Predictors of emergency reoperation and reoperative mortality were identified retrospectively in 172 patients who had the first bioprosthetic aortic valve replacement between 1975 and 1988 (mean age 46+/-13 years) and were subjected to replacement of the degenerated bioprostheses between 1978 and 1997 (mean age 56+/-14 years). Emergency reoperation had to be performed in 31 patients (18%). RESULTS: The operative mortality was 5.2% (9/172), 22.6% for emergency (odds ratio 11.17; 95%-confidence limit 4.33-28.85) and 1.4% for elective replacement of the degenerated aortic bioprosthesis (P<0.0001; OR=20.3). Patients who died at reoperation had higher transvalvular gradients before the primary aortic valve replacement (P=0.007), received smaller bioprostheses at the first operation (P=0.03), had later recurrence of symptoms after the first aortic valve replacement (P=0.04), a higher pre-reoperative New York Heart Association (NYHA) class (P=0.02), and a higher incidence of coronary artery disease (P=0.001) and pulmonary artery hypertension (P=0.009). Endocarditis before the primary aortic valve replacement (P=0.004), postoperative pneumonia at the first operation (P=0.005), pulmonary hypertension (P=0.0004) acquired during the interval, later recurrence of symptoms (P=0.04) after the first operation, a lower ejection fraction at the time of reoperation (P=0.03) and acute onset of bioprosthetic regurgitation (P=0.00002) were predictors for emergency surgery. Higher transvalvular gradients at the primary aortic valve replacement (P=0. 006), coronary artery disease (P=0.003) acquired during the interval, the need for concomitant coronary artery revascularization (P=0. 001), sex (P=0.02) and size (P=0.05) and type of the bioprostheses used (P=0.007) were incremental predictors for reoperative mortality which were independent of emergency surgery. CONCLUSIONS: Elective replacement of failed aortic bioprostheses is safe. Patients undergoing emergency reoperation have a considerably higher mortality. They can be identified by a history of native aortic valve endocarditis, higher transvalvular gradients at primary aortic valve replacement, smaller bioprostheses, and pulmonary hypertension or coronary artery disease acquired during the interval. A failing bioprosthesis must be replaced at its first sign of dysfunction.     

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.     

Prosthetic valve replacement in children

Between 1975 and 1998, 27 patients aged 3 months to 14 years underwent replacement of the aortic, mitral, tricuspid, and pulmonary valves. Five different types of prosthetic valves were used; three were mechanical valves and two were bioprosthetic valves. There were 3 hospital deaths. Among the 24 survivors there were 4 late deaths. Arrhythmia requiring pacemaker implantation occurred in 2 cases after AVR and TVR. Thromboembolic events occurred in 3 patients, all with mechanical valves in pulmonary position. Infective endocarditis occurred in 1 patient after PVR with a mechanical valve. No bleeding complication occurred among the patients on a regimen of Coumadin and Dipyridamole. Two patients, both with Hancock bioprosthesis, required a second valve replacement on account of severely calcified changes. Mechanical valves in left side heart had a satisfactory long-term performance. One patient who had undergone MVR for congenital parachute mitral valve received reoperation for growth. A larger sized prosthetic valve should be used at the first replacement, and special procedures including supra-annular positioning or annular augmentation are recommended for MVR or AVR respectively.     

Mitral valve replacement in the first 5 years of life

Between 1976 and 1986, 19 children aged 1 month to 5 years underwent replacement of the mitral (systemic atrioventricular) valve. Indications for valve replacement included isolated congenital mitral stenosis (n = 2), valve dysfunction associated with a more complex procedure (n = 15), and failed valvuloplasty (n = 2). Seven different valve types were used; nine were mechanical valves and ten were bioprosthetic valves. There were 6 hospital deaths (32%; 70% confidence limits, 20% to 47%). Among the 13 survivors there were 3 late deaths at a mean of 14 months after operation. The late deaths were unrelated to valve malfunction. Thromboembolic events occurred in 2 patients, both with mechanical valves. One minor bleeding complication occurred among 10 patients on a regimen of Coumadin (crystalline warfarin sodium). Five patients, all with bioprostheses, required a second valve replacement. Indications for reoperation included prosthetic valve regurgitation (n = 1) and calcific stenosis (n = 4). No early or late deaths occurred after second valve replacement. Survival was 51% +/- 12% (standard error) at 112 months after valve replacement. Analysis failed to identify age, weight, sex, previous operation, underlying cardiac lesion, or prosthesis size and type as significant risk factors for mortality. Mechanical valves had a lower reoperation rate compared with bioprostheses. These data suggest that although mitral valve replacement within the first 5 years of life is associated with a high operative and late mortality, satisfactory long-term palliation for many patients can be achieved. Mechanical valves are superior to bioprosthetic valves, and offer the best long-term results.     

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.     

Aortic valve replacement: choice between mechanical valves and bioprostheses

BACKGROUND: The choice between a mechanical or bioprosthetic valve replacement device is not always clear, although patient age is most often the determining factor. We reviewed our experience with patients undergoing aortic valve replacement (AVR) in order to assess and compare long-term outcomes between patients receiving a mechanical valve and those receiving a bioprosthesis. METHODS: Three hundred fifty-two patients underwent AVR with or without coronary artery bypass between 1993 and 2004: 189 received a mechanical valve and 163 a bioprosthesis. Events included: late mortality, thrombo-embolic events, stroke, bleeding events, valve thrombosis, endocarditis, reoperation, and coronary catheterization. RESULTS: Patients in the bioprosthesis group were older (71 +/- 11 vs. 65 +/- 13) than in the mechanical group (p < 0.0001). There was no difference in operative mortality (6.8%) or morbidity. Follow-up (61 +/- 40 months) was available in 87%. For mechanical valves and bioprostheses, respectively: 3-, 5-, and 10-year survival was 92%, 86%, and 69% versus 90%, 86%, and 71% (p = n.s.); and event-free survival was 79%, 68%, and 41% versus 79%, 68%, and 44% (p = n.s.). Five patients (3%) in each group required re-replacement of their aortic valve (p = n.s.). Coronary artery disease requiring bypass surgery did not affect long-term survival. Age at operation and renal failure were the only predictors for late mortality. CONCLUSIONS: Survival and event-free survival are similar for patients receiving a mechanical or biological aortic valve substitute. Selection of a valve replacement device should be based on life expectancy, patient preference, ability to take anticoagulants, lifestyle, risk of bleeding, and risk of reoperation. Patient age alone should not be the determining factor.     

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.     

Replacement of degenerated mitral and aortic bioprostheses without explantation.

BACKGROUND: The most common indication for reoperation in patients with a bioprosthetic valve is primary tissue failure. Explantation of the bioprosthesis is time consuming, and for a mitral valve, may be complicated by cardiac rupture at the atrioventricular junction or the posterior left ventricular wall where a strut is imbedded, injury to the circumflex artery, and late perivalvular leak; for an aortic valve, annular disruption and perivalvular leak may complicate explantation. A new approach to simplify these procedures and avoid these complications, by excising only the bioprosthetic tissue and attaching a bileaflet mechanical valve to the intact stent, was developed in 1991 and was evaluated over a 9-year period in 50 patients who had had one (34), two (10), three (4), or four (2) previous open cardiac operations. METHODS: Since 1991, we have replaced degenerated mitral bioprostheses in 34 patients (25 to 84 years of age; 12 male, 22 female) by preserving the stent and suturing a St. Jude or Carbomedics bileaflet valve to the atrial side of the bioprosthetic cuff; the mitral valve was exposed through a median sternotomy in 21 patients and through a right anterolateral thoracotomy in 13. Using a similar approach, starting in 1995, 16 additional patients (55 to 73 years of age; 11 male, 5 female) with degenerated aortic bioprostheses had the aortic valve replaced by excising the bioprosthetic tissue and amputating the struts, then suturing a Carbomedics valve to the aortic side of the bioprosthetic cuff. This allows the use of a bileaflet valve similar in size to the bioprosthesis with exact matching of the orifices. RESULTS: Bypass time averaged 61 +/- 14 minutes and aortic cross-clamp time 43 +/- 12 minutes. There has been no operative mortality. Three late deaths occurred at 9, 37, and 58 months, and were not valve related. No gradients of hemodynamic significance have been detected on transesophageal echocardiographic follow-up. CONCLUSIONS: Leaving the bioprosthetic cuff intact eliminates the need for extensive dissection, thus shortening and simplifying the procedure and diminishing its attendant mortality and morbidity. This valve-on-valve approach also allows replacement of a degenerated bioprosthesis with a bileaflet valve of comparable size rather than a smaller one jammed into the orifice of the bioprosthetic stent, thus avoiding undue trauma to the bileaflet valve and maintaining excellent hemodynamic function.     

Comparative analysis of mechanical and bioprosthetic valves after aortic valve replacement

Comparative long-term performance characteristics of Bj?rk-Shiley mechanical and bioprosthetic valves were analyzed for patients undergoing aortic valve replacement between 1976 and 1981. A total of 419 patients received either a standard Bj?rk-Shiley (n = 266) or bioprosthetic (porcine, n = 126, or pericardial, n = 27) aortic valve. Cumulative patient follow-up was 1,705 patient-years; the average patient follow-up was 4.1 +/- 2.7 years. Survival data were obtained for all but 11 patients (97% complete follow-up) up to 9 years after operation. Survival at 5 years was 81% +/- 4% (+/- standard error) for Bj?rk-Shiley and for bioprosthetic valve recipients. Valve failure in the Bj?rk-Shiley group was predominantly due to valve-related mortality and did not result from structural failure. Patients with bioprosthetic valves experienced valve failure as a result of prosthetic valve endocarditis and intrinsic valve degeneration. Although patients with bioprostheses experienced a lower incidence of valve-related morbidity than Bj?rk-Shiley valve recipients (p less than 0.03), no difference could be demonstrated in the incidence of valve-related mortality or valve failure at 5 years between bioprosthetic and Bj?rk-Shiley valves. Mortality rate from valve failure was higher for Bj?rk-Shiley (86%, 12/14) than bioprosthetic valves (36%, 5/14) (p less than 0.01).     

Risk factors for atherosclerosis and the degeneration of pericardial valves after aortic valve replacement

BACKGROUND: Recent studies have demonstrated the influence of atherosclerotic risk factors on the progression of aortic stenosis. We hypothesized that risk factors for atherosclerosis might also be involved in the degeneration of pericardial heart valves and might lead to reoperation as a result of structural valve failure, especially in younger patients with high degeneration rates. METHODS: In 1984 and 1985, 161 patients (74% male; mean age, 54.4 +/- 1.0 years; age range, 17-76 years; median age, 56.5 years) survived isolated aortic (n = 137) or combined aortic and mitral (n = 25) valve replacement with a Hancock extracorporeal pericardial valve. Of these patients, 90 (56%) had reoperations as a result of tissue failure of the aortic valve 5.6 +/- 0.25 years postoperatively. RESULTS: The patient group was split in half at the median age. In patients aged 57 years or younger, diabetes mellitus, female sex, cigarette smoking, and high cholesterol and triglyceride levels were associated with accelerated valve failure. In a multivariate model sex (female, P =.001), smoking (P =.001), diabetes mellitus (P =.020), and cholesterol levels (P =.011) are risk factors for reoperation. Patients without risk factors had reoperation after a mean of 9.25 +/- 0.88 years compared with 4.05 +/- 0.43 years (P =.0002) in patients with 2 or 3 risk factors. CONCLUSIONS: Risk factors of atherosclerosis might play a substantial role in the degeneration of aortic bioprosthetic valves. Lowering of serum lipid levels, smoking cessation, therapy for diabetes, and careful patient selection could be new strategies to postpone degeneration. Younger patients could then possibly benefit from the advantages of bioprostheses.     

Long-term follow-up of cardiac valve replacement using bioprosthesis in patients 70 years old and older

Good long-term results with the bioprosthetic valves for patients 70 years old and older have been reported. However, because the average lifespan is increasing, we aimed to clarify whether patients older than 70 may still be candidates for valve re-replacement. Seventy-one patients 70 years old and older, who received a total of 81 bioprosthetic valve replacements during 73 procedures between 1988 and 2000, were reviewed. There were 8 hospital and 7 late deaths. Ten-year actual survival after valve replacement was 73.5%, and 82.8% when hospital deaths were excluded. During the follow-up period, 2 patients received mitral valve re-replacement. Ten years of freedom from reoperation were found in 66.7% for all valves and in 50.0% for mitral valves. The average lifespan in Japan is currently 77.64 years for men and 84.62 years for women; therefore, valve degeneration in patients who receive bioprosthesis replacement in their early 70s should be anticipated.     

Valve replacement surgery in patients with end-stage renal disease: long-term results

BACKGROUND: The life expectancy of patients with chronic renal failure who are dependent on dialysis is very poor. This study was undertaken to determine time-related outcomes in dialysis patients requiring cardiac valve replacement. METHODS: From 1994 to 2001, 29 end-stage renal disease (ESRD) patients on hemodialysis (HD) program underwent 30 valve replacement operations: 29 received mechanical valves (97%), and one received bioprosthetic valves. The sites of valve replacement were 11 aortic (36.7%), 18 mitral (60%), and one both aortic and mitral (3.3%). Mean age was 42.46 +/- 14.26 years (range 17-75 years). Follow-up was completed in 28 patients (96.5%). RESULTS: Early postoperative mortality (in the first 30 days) was 3.4% (n = 1). The overall estimated Kaplan-Meier survival was 56.7% at 36 months, 46.7% at 60 months, and 43.3% at 96 months. HD program was discontinued for two patients after renal transplantation in the follow-up period. All patients, except the one with bioprosthesis, used warfarin sodium for anticoagulation and none of them had bleeding. One of the patients had a major cerebrovascular accident (CVA) and another one had a minor CVA at the follow-up (6.7%). CONCLUSIONS: Life quality is better and life expectancy is longer after valve replacement in ESRD patients who have valvular disease. Also, longer life expectancy increases the probability for finding donors for kidney transplantation.     

Risk of Reoperative Valve Replacement for Failed Mitral and Aortic Bioprostheses

Background. One factor influencing the choice of mechanical versus bioprosthetic valves is reoperation for bioprosthetic valve failure. To define its operative risk, we reviewed our results with valve reoperation for bioprosthetic valve failure.

Methods. Records of 400 consecutive patients having reoperative mitral, aortic, or mitral and aortic bioprosthetic valve replacement from January 1985 to March 1997 were reviewed.

Results. Reoperations were for failed bioprosthetic mitral valves in 219 patients, failed aortic valves in 153 patients, and failed aortic and mitral valves in 28 patients. Including 26 operations (6%) for acute endocarditis, 153 operations (38%) were nonelective. One hundred nine patients (27%) had other valves repaired or replaced, and 72 (18%) had coronary bypass grafting. The incidence of death in the mitral, aortic, and double-valve groups was respectively, 15 (6.8%), 12 (7.8%), and 4 (14.3%); and the incidence of prolonged postoperative hospital stay (>14 days) was, respectively, 57 (26.0%), 41 (26.8%), and 8 (28.6%). Only 7 of 147 patients (4.8%) having elective, isolated, first-time valve reoperation died. Multivariable predictors (p < 0.05) of hospital death were age greater than 65 years, male sex, renal insufficiency, and nonelective operation; and predictors of prolonged stay were acute endocarditis, renal insufficiency, any concurrent cardiac operation, and elevated pulmonary artery systolic pressure.

Conclusions. Reoperative bioprosthetic valve replacement can be performed with acceptable mortality and hospital stay. The best results are achieved with elective valve replacement, without concurrent cardiac procedures.     

Aortic valve disease with severe ventricular dysfunction: stentless valve for better recovery

BACKGROUND: Stentless bioprostheses and homografts show better hemodynamic profiles compared with conventional stented bioprostheses and mechanical valves. Few data are available on stentless aortic valve implantation for patients with severe left ventricular dysfunction. The aim of this retrospective study was to assess the potential benefits of stentless aortic valve implantation for patients undergoing isolated aortic valve replacement with left ventricular ejection fraction < or = 35%. METHODS: From November 1988 through March 2000, 53 patients (45 men and 8 women, aged 64.2 +/- 15.2 years) with a LVEF < or = 35% (mean EF, 28.7 +/- 5.4%) underwent isolated, primary aortic valve replacement for chronic aortic valve disease. Twenty patients received stentless aortic valves and 33 patients received conventional stented bioprostheses and mechanical valves. Predictive factors for LVEF recovery at echocardiographic follow-up (36.2 +/- 32.1 months) were analyzed by simple and multiple regression analysis. RESULTS: There were no significant differences between groups in early and late mortality. Stentless aortic valve implantation required a longer aortic cross-clamp time (p = 0.037). The stentless aortic valve group showed a better LVEF recovery (p = 0.016). Stentless aortic valves had a larger indexed effective orifice area compared with conventional stented bioprostheses and mechanical valves (p < 0.0001). A smaller indexed effective orifice area (p = 0.0008), chronic obstructive pulmonary disease (p = 0.015), and implantation of a conventional stented bioprosthesis or mechanical valve (p = 0.016) were related to reduced LVEF recovery by univariate analysis. A larger indexed effective orifice area (p = 0.024) was an independent predictive factor for a better LVEF recovery by multivariate analysis. CONCLUSIONS: Stentless aortic valve implantation for patients with severe left ventricular dysfunction, even if technically more demanding, is a safe procedure that warrants a larger indexed effective orifice area leading to an enhanced LVEF recovery.     

Use of the Carpentier-Edwards porcine bioprosthesis: assessment of a patient selection policy.

The Carpentier-Edwards bioprosthesis was implanted in 369 patients (414 valves) between May 1977 and December 1987 (age 67.2 +/- 0.5 years); 242 had aortic valve replacement, 80 had mitral valve replacement, 44 had multiple valve replacement, of which 41 were aortic and mitral valve replacement, 2 had isolated tricuspid valve replacement, and 1 had a pulmonary valve replacement. The selection criteria were the following: shorter life expectancy (253 patients) or contraindications to anticoagulants for organic (113 patients) or psychologic (38 patients) reasons, or both. The early mortality rate was 11.1% (aortic valve replacement, 9.1%; mitral valve replacement, 12.4%; aortic and mitral valve replacement, 23.1%). Total cumulative follow-up was 1456 pt-yr (mean 4.4 years, range 1 to 148 months), and the patient evaluation was 99.5% complete. Late mortality was 4.9%/pt-yr. Five-year survival was 70.4% +/- 2.7% overall, 74.3% +/- 3.2% after aortic valve replacement, 60.9% +/- 6.2% after mitral valve replacement (p < 0.03), and 60.7% +/- 8.1% after aortic and mitral valve replacement. Eight patients were reoperated on for primary tissue failure, and freedom from reoperation for structural valve deterioration was 97.5% +/- 1.2% at 5 years and 95.6% +/- 1.8% at 8 years. Failing aortic bioprostheses were explanted in four patients (0.4%/pt-yr) and mitral bioprostheses in seven (1.6%/pt-yr). No patient whose valve was inserted after the age of 70 had to be reoperated on for structural valve dysfunction. The probability of freedom from thromboembolism after 5 and 8 years of follow-up was 93.1% +/- 1.6% and 92.2% +/- 1.8%, respectively. The prevalence of anticoagulant-related hemorrhage was 0.8%/pt-yr (major 0.6%, minor 0.2%). Anticoagulants had to be maintained in 16.3% of the patients: 5.9% after aortic valve replacement, 35.7% after mitral valve replacement, and 45.8% after aortic and mitral valve replacement, while 80.0% were on a regimen of antiplatelet drug therapy. Prosthetic valve endocarditis happened in five patients (0.3%/pt-yr). Freedom from all valve-related morbidity and mortality, including hospital deaths, was 71.0% +/- 2.7% at 5 years and 58.6% +/- 4.6% at 8 years and was significantly better in the aortic valve replacement group (61.3% +/- 6.6% at 8 years) compared with the mitral valve replacement group (54.4% +/- 7.7% at 8 years; p = 0.04). This study confirms the satisfactory performance of the Carpentier-Edwards valve after aortic valve replacement in elderly patients.(ABSTRACT TRUNCATED AT 400 WORDS)     

Long-term outcomes of valve replacement with modern prostheses in young adults.

OBJECTIVES: To examine the multiple impacts of valve replacement on the lives of young adults. METHODS: Patients (N=500) between age 18 and 50 who had aortic valve replacement (AVR) and/or mitral valve replacement (MVR) with contemporary prostheses were followed annually. Events, functional status, and quality of life were examined with regression models. RESULTS: Median follow-up was 7.1+/-5.3 years (maximum 26.7 years). Five, 10, and 15-year survival was 92.7+/-1.7, 88.3+/-2.4 and 80.1+/-4.7% after AVR, and 93.1+/-2.3, 79.5+/-4.3 and 71.5+/-5.4% after MVR, respectively. Survival decreased with concomitant coronary disease (hazard ratio (HR): 4.5) and preoperative LV grade (HR: 2.0/grade increase) in AVR patients, and with atrial fibrillation (HR: 5.5), coronary disease (HR: 5.7), preoperative left atrial diameter (HR: 3.0/cm increase) and NYHA class (HR: 2.1/class increase) in MVR patients. Despite reoperation, late survival was equivalent between bioprostheses and mechanical valves in both implant positions. The ten-year cumulative incidence of embolic stroke was 6.3+/-2.4% for mechanical AVR patients, 6.4+/-2.9% for bioprosthetic AVR patients, 12.7+/-3.9% for mechanical MVR patients, and 3.1+/-3.1% for bioprosthetic MVR patients. Atrial fibrillation (HR: 2.8) and smoking (HR: 4.0) were risk factors for stroke in MVR patients. In AVR patients, SF-12 physical scores, freedom from recurrent heart failure, and freedom from disability were significantly higher in bioprosthetic than mechanical valve patients. Career or income limitations were more often subjectively linked to a mechanical prosthesis in both implant positions. CONCLUSIONS: Late outcomes of modern prosthetic valves in young adults remain suboptimal. Bioprostheses deserve consideration in the aortic position, as mechanical valves are associated with lower physical capacity, a higher prevalence of disability, and poorer disease perception. Early surgical referral and atrial fibrillation surgery may improve survival after MVR.