Up to 8-year follow-up of valve replacement with carbomedics valve

BACKGROUND: The aim of this study was to report midterm valve replacement (VR) results with the Carbo-Medics valve (Sulzer Carbomedics, Austin, TX). METHODS: From 1991 to 1999, 468 patients aged 13 to 76 years (mean 56 years) underwent VR with CarboMedics valve: 239 aortic (A), 167 mitral (M), and 62 A+M or double valve replacement (DVR). Mean follow-up time was 4.4 years; follow-up was 99.1% complete for 2,016 patient-years (PY). The anticoagulation level was targeted to an international normalized ratio of 1.47 to 2.8. RESULTS: The hospital mortality rate was 1.2%. Actuarial analysis for the entire group at 7 years for survival was 87%+/-2.3%. Freedom from valve-related death was 94%+/-1.9%. Freedom from thromboembolic and bleeding events, respectively, were as follows: for AVR, 82%+/-4.9% (2.4%/PY) and 88%+/-2.9% (1.6%/PY); for MVR, 95%+/-2.1% (0.8%/PY) and 91%+/-3.1% (1.3%/PY); and for DVR, 96%+/-3.2% (0.7%/PY) and 85%+/-9.7% (1.0%/PY). Actuarial freedom from reoperation was 98%+/-1.4%. CONCLUSIONS: The CarboMedics valve can be implanted with satisfactory early mortality and a low incidence of valve-related events even under low-intensity anticoagulation, as shown in a Japanese population.     

Mitral valve repair and replacement for rheumatic disease

OBJECTIVES: Mitral valve repair may be technically feasible in patients with suitable anatomy, but the appropriateness of repair for rheumatic disease remains controversial. We evaluated our late outcomes after mitral repair and replacement for rheumatic disease. METHODS: Five hundred seventy-three patients underwent mitral valve surgery for rheumatic disease at our institution from 1978-1995. Follow-up was 98% complete (mean, 68 +/- 46 months). Survival and morbidity were evaluated by Kaplan-Meier analysis and Cox regression, including propensity score analysis. RESULTS: Mean age was 54 +/- 14 years, 55% of patients had congestive heart failure, 22% were undergoing redo mitral valve surgery, and 9% also underwent coronary bypass. Mitral stenosis was present in 53%, regurgitation in 15%, and both in 32%. Valve repair was performed in 25%, bioprosthetic replacement was performed in 28%, and a mechanical valve was placed in 47%. Patients undergoing repair were younger and less likely to be undergoing reoperation or to have atrial fibrillation than those undergoing replacement (P =.001). The operative mortality rate was 4. 2%. Better late cardiac survival was independently predicted by valve repair rather than replacement (P =.04) after adjustment for baseline differences between patients. Freedom from reoperation was greatest (P =.005) but that from thromboembolic complications was worst (P <.0001) after mechanical valve replacement. Twenty-three patients underwent reoperation after initial repair, with no operative deaths. CONCLUSIONS: Mechanical valves minimize reoperation but limit survival and increase thromboembolic complications. Patients undergoing valve repair had improved late cardiac survival independent of their preoperative characteristics. Rheumatic mitral valves should be repaired when technically feasible, accepting a risk of reoperation, to maximize survival and reduce morbidity.     

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.     

Early clinical experience with the On-X prosthetic heart valve

The study aimed to assess the performance of the On-X valve (Medical Carbon Research Institute, Austin, TX). Between December 2000 and January 2003 On-X valves were implanted in 400 patients aged 19-85 years (mean: 55.6+/-16), 290 males and 210 females. There were 120 cases of aortic valve replacement (AVR), 258 mitral valve replacement (MVR) and 22 combined aortic and mitral valve replacement (DVR). Additional procedures were performed in 144 patients. Patients were followed up prospectively at 3- to 6-month intervals. Mean follow-up was 38.4+/-11.8 months (maximum 55.6 months). Overall hospital mortality was 3.5%. Freedom from adverse events at 4 years in the study were as follows: thromboembolism, 99.1% for AVR, 98.3% for MVR and 94.7% for DVR patients; thrombosis, 100% for AVR, 99.2% for MVR and 94.7% for DVR; bleeding events, 99.1% for AVR, 99.2% for MVR and 88.8% for DVR; prosthetic endocarditis, 98.2% for AVR, 99.2% for MVR and 94.7% for DVR. Overall survival at 4 years was 92+/-1%. At echocardiographical examination within 1 year of the AVR, the mean aortic valve gradient was 12.8+/-6, 10.3+/-3, 9.0+/-4, 8.3+/-3, and 6.2+/-3 mmHg for 19, 21, 23, 25, 27/29 mm valve sizes, respectively. MVR mean gradient was 4.9+/-2, 4.5+/-1.2 and 4.0+/-0.8 mmHg for 25, 27/29, 31/33 mm valve sizes, respectively. On-X valve is a highly effective mechanical valve substitute with low morbidity and mortality and good functional results.     

Long-term clinical results after combined aortic and mitral valve replacement

The results after 282 consecutive double (aortic & mitral) valve replacements (DVR) are compared with our previously reported experience after mitral (MVR, n = 810) and aortic valve replacement (AVR, n = 1753). All but one patient received Bj?rk-Shiley valves. The follow-up which closed on August 1, 1985 was 99.3% and covered 16,869 patient-years (mean 6.3 years/patient). Autopsies were performed in 74% of all fatalities. Early mortality rates were identical in the three patient groups, and late mortality did not differ between MVR and DVR patients. The fraction of valve-related mortality was similar in all groups. Anticoagulant-related bleeding was equally common in all patient groups. The incidences of thromboembolism, reoperation and valve failure did not differ between MVR and DVR patients, but were significantly higher than among AVR patients. With the exception of a slightly increased incidence of prosthetic valve endocarditis, the results after DVR equal those after MVR. In cases with severe mitral valve disease but borderline aortic valve disease, primary DVR is clearly justified and eliminates the need for, and risks of, a secondary AVR.     

Determinants of survival and valve failure after mitral valve replacement

A prospective evaluation of 333 consecutive patients undergoing isolated mitral valve replacement between 1982 and 1985 was performed to identify the predictors of survival and valve failure. Follow-up between 2 and 6 years postoperatively (mean, 32 +/- 17 months) was 98% complete. Four prostheses were inserted to permit a prospective evaluation of alternative valves: Bj?rk-Shiley mechanical (n = 118), Ionescu-Shiley pericardial (n = 146), Carpentier-Edwards porcine (n = 38), and Hancock pericardial (n = 31). Hospital mortality was 6%, and actuarial survival at 5 years was 74% +/- 5%. Multivariate Cox regression analysis identified advancing age (less than 40 years, 88% +/- 7%; greater than 70 years, 50% +/- 14%) and poor left ventricular function (ejection fraction less than 0.20, 62% +/- 17%; ejection fraction greater than 0.60, 80% +/- 7%) as independent predictors of postoperative survival. Freedom from structural valve dysfunction, prosthetic valve endocarditis, reoperation, and valve-related mortality and morbidity were 86% +/- 4%, 91% +/- 4%, 81% +/- 4%, and 72% +/- 5%, respectively, at 5 years. The actuarial incidence of valve failure was inordinately high with the Hancock pericardial valve (p less than 0.05). Freedom from thromboembolic events (78% +/- 8% at 5 years) was significantly lower in patients with poor ventricular function (ejection fraction (less than 0.20, 54% +/- 20%; ejection fraction greater than 0.60, 73% +/- 11%; p less than 0.05). Survival after mitral valve replacement was determined by age and left ventricular function. Premature failure of the Hancock pericardial valve resulted in an unacceptable rate of valve-related complications.     

Midterm experience with the Sorin Bicarbon heart valve prosthesis for rheumatic disease

BACKGROUND: In this study, we present a single center experience with Bicarbon bileaflet valve in 307 patients with rheumatic heart disease. METHODS: Between August 1998 and September 2000, 307 patients underwent heart valve replacement using the Bicarbon bileaflet valve (Sorin Biomedica, Saluggia, Italy) with an average age of 47.19+/-13.21 years (range 14 to 80 years), consisting of 147 males and 160 females at Alkan Hospital, Cardiovascular Surgery Department. Aortic valve replacement (AVR) was performed in 77 patients, mitral valve replacement (MVR) in 156 patients and double valve replacement (DVR) in 74 patients. RESULTS: The early mortality rate was 3.3% (10/307) and there was no late mortality. The actuarial survival rate, including hospital mortality, was 96.74+/-1.01% for the whole group, 96.5+/-1.5% for the MVR group, 97.4+/-1.8% for the AVR group and 97.3+/-1.9% for the DVR group at 35 months. One patient had obstructive valve thrombosis with MVR. The 35 months actuarial freedom from valve thrombosis was 99.58+/-0.4% for the whole group. Four patients were reoperated and the 35 months actuarial freedom from reoperation was 98.53+/-0.7% for the whole group, 98.65+/-0.9% for the MVR group, 96.73+/-02% for the DVR group and 100% for the AVR group. No instances of perivalvular leak, hemolysis, endocarditis or embolism were observed during the entire follow-up period. Mean follow-up duration was 16.5+/-7.9 months (ranged 4 to 35 months). CONCLUSION: We have presented our mid-term results with the Sorin Bicarbon bileaflet valve in patients with rheumatic heart disease, which provided good clinical performance combined with meticulous patient care and advanced surgical techniques.     

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.     

Case-matched comparison of mitral valve replacement and repair

Carpentier's techniques of prosthetic ring mitral valve repair for mitral regurgitation offer the potential for immediate and long-term improvement in valve function without the necessity of replacing the native valve with a prosthesis. A consecutive, case-matched series of 65 patients with prosthetic ring mitral valve repair was compared with 65 patients undergoing mitral valve replacement for mitral regurgitation. The aortic cross-clamp time was 57 +/- 33 minutes in the repair operations and 41 +/- 25 minutes in the replacement operations (p = 0.003). The cardiopulmonary bypass time was 154 +/- 44 minutes in the repair operations and 113 +/- 41 minutes in the replacement operations (p = 0.0001). There were no myocardial infarctions in the hospital in either group. Hospital death was noted in 1.5% of repairs and 4.6% of replacements (p = not significant). Survival at 4 years was 0.84 for repairs and 0.82 for replacements (p = not significant). Freedom from reoperation to replace the mitral valve at 4 years was 62 of 65 patients in the repair group and 64 of 65 patients in the replacement group (p = not significant). In-hospital and midterm results in a closely matched population show that mitral valve repair yields results comparable with those of replacement despite a more difficult procedure. The benefits of maintaining the native valve with chordal and papillary muscle structure intact and avoidance of prosthetic valve implantation may then become apparent with longer follow-up.     

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.     

Single-center experience with the bicarbon bileaflet prosthetic heart valve in Japan

We analyzed midterm results using the Bicarbon valve in a single center. Forty-four patients had aortic valve replacement (AVR), 48 had mitral valve replacement (MVR), and 13 had both aortic and mitral valve replacement (DVR). The mean age of the 105 patients was 61.2 +/- 11.3 years. The mean follow-up was 1.8 +/- 1.1 years with a cumulative follow-up of 188 patient-years. There were 5 early deaths (4.7%: 4 in the AVR group and 1 in the MVR group) and 5 late deaths (2.7% per patient-year: 3 malignancy, 1 cerebral hemorrhage, 1 myocardial infarction). Survival at 3 years was 91 +/- 4% in the AVR group, 92 +/- 5% in the MVR group, and 66 +/- 23% in the DVR group. The linearized incidence of thromboembolic complications, hemorrhagic complications, and paravalvular leaks in all patients was 1.06 +/- 2.34%, 1.60 +/- 2.53%, and 0.53 +/- 2.22% per patient-year, respectively. No other complications were observed. In conclusion, the Bicarbon prosthetic heart valve has shown excellent clinical results associated with a low incidence of valve-related complications.     

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)     

Repeated thromboembolic and bleeding events after mechanical aortic valve replacement

BACKGROUND: The choice of a valve substitute in young adults requires a decision balancing the risks of long-term anticoagulation versus reoperation(s). This article analyzes the long-term risk and determinants of thromboembolic (TE) and bleeding (BLE) complications after mechanical aortic valve replacement (AVR). METHODS: From December 1963 to January 1974, 249 patients survived a mechanical AVR at our institution. Mean age was 41.8+/-12.4 years and 81% (n = 202) were male. Ball valves were implanted in 24% (n = 61) and disc valves in 76% (n = 188). Patients were anticoagulated with vitamin K antagonists and dipyridamole. A total of 4,855 patient-years was available for analysis. Mean follow-up was 19.5+/-9.4 years and was 100% complete. Analyses were performed with Kaplan-Meier and multivariable Cox regression methods. RESULTS: One hundred and two patients had one TE or BLE postoperative event and 58 patients had two postoperative events. Six patients had more than five postoperative events. Freedom from a first postoperative event was 74.8%+/-2.9%, 55.3%+/-3.5%, and 46.8%+/-4.0% at 10, 20, and 30 years, respectively. Freedom from a second postoperative event was 45.4%+/-5.4%, 29%+/-6.0%, and 23.2%+/-7.1% at 10, 20, and 30 years, respectively. Multivariate predictors for TE or BLE complications were ball valve (Odds Ratio (OR) = 2.9), postoperative endocarditis (OR = 2.2), and any surgery (OR = 2.2). The incidence of events was highest the first 5 postoperative years. CONCLUSIONS: The risk of adverse events is highest the first 5 postoperative years. Once an event has occurred, the risk for a second event is increased. The incidence and frequency of events is substantial and should be considered in the choice of a valve substitute.     

Factors affecting mitral valve reoperation in 317 survivors after mitral valve reconstruction.

From a very heterogeneous group of 340 patients undergoing mitral valve reconstruction from 1969 through 1988, 313 hospital survivors were analyzed for factors affecting the occurrence of reoperative mitral valve procedures related to native mitral valve dysfunction. Follow-up was 100% and extended from 1 year to 20 years (mean follow-up, 7.2 years). Sixty-three patients (18.5% of the 340) required mitral valve reoperation at a mean postoperative interval of 6 years (range, 1 to 15 years). Incremental risk factors analyzed for the event late mitral valve failure included age, sex, preoperative New York Heart Association class, cause of valvular disease, pathophysiology of the mitral valve, previous mitral valve operation, mitral valve pathology, and estimation of mitral valve function at operation after repair. Mitral valve pathophysiology affected the actuarial freedom from mitral valve replacement (p = 0.023 [log-rank]). Actuarial freedom from mitral valve reoperation was 90% at 5 years and 80% at 8 years in patients who had either pure mitral regurgitation or isolated mitral stenosis compared with 80% and 72% at 5 and 10 years, respectively, in patients who had mixed mitral stenosis and regurgitation (p = 0.023). Patients undergoing late reoperation were younger (51.7 +/- 1.56 years [+/- the standard error of the mean]) than those not having reoperation (p less than 0.0003). Durability of the repair was less in patients with rheumatic heart disease (p less than 0.025) and greater in patients with ischemic heart disease (p less than 0.004). Seventy-three percent of patients undergoing reoperation had concomitant operations compared with 68% of those not having reoperation (p less than 0.001).(ABSTRACT TRUNCATED AT 250 WORDS)     

Late results after left-sided cardiac valve replacement in children

Selection of types of cardiac valve substitutes for children remains controversial. Between 1976 and 1984, 166 children, 15 years of age or younger, underwent aortic (N = 53) or mitral valve replacement (N = 90) or both (N = 23). Biological prostheses were used in 84 patients and mechanical prostheses in 71; both a mitral bioprosthesis and an aortic mechanical valve were used in 11 patients. The overall early mortality was 9%. Mean follow-up intervals were 4.1 years for the bioprosthesis group, 3.3 years for the mechanical valve group, and 3.5 years for the group receiving both. The 7 year survival rates (+/- standard error) were 63% +/- 6% in the bioprosthesis group and 70% +/- 7% in the mechanical valve group (p = NS). After aortic valve replacement the 7 year survival rates were 66% +/- 14% (bioprosthesis group) and 77% +/- 9% (mechanical valve group) (p = NS); after mitral valve replacement the rates were 65% +/- 7% (bioprosthesis group) and 54% +/- 17% (mechanical valve group) (p = NS). The incidence of thromboembolic events was 0.6% +/- 0.4% per patient-year in the bioprosthesis group (none after aortic valve replacement, 0.8% +/- 0.6% per patient-year after mitral valve replacement) and 1.4% +/- 0.8% per patient-year in the mechanical valve group (0.7% +/- 0.7% per patient-year after aortic valve replacement, 4.0% +/- 2.8% per patient-year after mitral valve replacement) (p = NS). The linearized rates of reoperation were 10.4% +/- 1.8% per patient-year (bioprosthesis group) and 2.3% +/- 1.0% per patient-year (mechanical valve group) (p less than 0.001). The 7 year probability rates of freedom from all valve-related complications were 43% +/- 6% in the bioprosthesis group and 86% +/- 4% in the mechanical valve group (p less than 0.001). In the aortic position, a mechanical adult-sized prosthesis can always be implanted, and satisfactory long-term results can be anticipated. In the systemic atrioventricular position, the results are less than satisfactory with either type of prosthesis; every effort should be made to preserve the natural valve of the child.     

Long-term durability of the Hancock porcine bioprosthesis following combined mitral and aortic valve replacement: an 11-year experience

Long-term evaluation of patients undergoing combined mitral and aortic valve replacement (MVR + AVR) with a porcine bioprosthesis provides the opportunity for a direct comparison of the durability of the mitral versus the aortic porcine bioprosthesis in the same patient. From 1970 to 1983, 71 patients underwent MVR + AVR with Hancock porcine bioprostheses. There were 46 men an 25 women ranging in age from 21 to 64 years (mean, 47.5 +/- 5 years). Sixteen patients (22.5%) died at operation. The survivors were followed from 0.2 to 11.5 years (mean, 5.7 +/- 3 years). Duration of follow-up was 313 patient-years and was 100% complete. Overall late mortality was 6.7 +/- 1.4% per patient-year (linearized incidence), and actuarial survival was 54.2 +/- 8% at 11 years. Endocarditis occurred in 4 patients (linearized incidence of 1.3 +/- 0.6% per patient-year); thromboembolic events were sustained by 4 patients (linearized incidence of 1.3 +/- 0.6% per patient-year); the event was fatal in 1 patient. Actuarial freedom from thromboembolism was 90 +/- 4.8% at 11 years. Reoperation for primary tissue failure was performed in 11 patients (linearized incidence of 3.5 +/- 1% per patient-year) with no deaths; in 7 patients both bioprostheses were explanted, and in 4, only the mitral bioprosthesis was replaced. The durability of explanted aortic and mitral porcine bioprostheses was not significantly different, and the evaluation of seven pairs of explanted aortic and mitral bioprostheses showed similar amounts of calcification. Actuarial freedom from reoperation because of primary tissue failure was 44.6 +/- 13.7% at 11 years.(ABSTRACT TRUNCATED AT 250 WORDS)     

Long-term clinical results after aortic valve replacement with mechanical heart valves and mitral valve replacement with porcine valves]

Long-term clinical results of aortic valve replacement (AVR) with mechanical heart valves and mitral valve replacement (MVR) with porcine valves were analysed. Sixty-three patients received isolated AVR and 48 received isolated MVR. Sixty-eight patients with MVR including double or triple valve replacement were also added in order to evaluate the primary tissue failure (PTF). The patients with operative deaths were excluded. Survival rate at 11 years in AVR was 68 +/- 10% and 67 +/- 15% in MVR without statistical difference. At 11 years, 76 +/- 8% of the patients in AVR were free from valve-related complications in contrast with the poor result of 34 +/- 31% in MVR (p less than 0.01). Main cause of this poor result in MVR was PTF as indicated in following event free rates; 83 +/- 9% at 7 years, 61 +/- 25% at 10 years and 49 +/- 31% at 13 years. There was no statistical difference between patients of above 50 years and below 49 years in PTF. Valve-related death event free was 93 +/- 5% in AVR and 86 +/- 11% in MVR at 11 years (not significant), however, there was statistical difference in re-operation event free rate as 94 +/- 5% in AVR and 76 +/- 11% in MVR at 11 years (p less than 0.001). These results suggest that the use of porcine valves in mitral position is confined to the selected patients.     

Ross procedure in rheumatic aortic valve disease.

OBJECTIVE: To assess the results of aortic valve replacement with the pulmonary autograft in patients with rheumatic heart disease. METHODS: From October 1993 through September 2003, 81 rheumatic patients with aortic valve disease, mean age 29.5+/-11.9 years (11-56 years) underwent, the Ross procedure with root replacement technique. Forty patients were 30 years of age or below (young rheumatics). Associated procedures included mitral valve repair (n=19), open mitral commissurotomy (n=15), tricuspid valve repair (n=2), and homograft mitral valve replacement (n=2). RESULTS: Early mortality was 7.4% (six patients). Mean follow-up was 92.3+/-40.9 months (7-132 months, median 109 months). Sixty of the 73 patients whose follow-up was available (82%) had no significant aortic regurgitation. Re-operation was required in seven (8.4%) patients for autograft dysfunction with failed mitral valve repair (n=3), autograft dysfunction alone (n=2) and failed mitral valve repair alone (n=2). No re-operations were required for the pulmonary homograft. There were six (7.5%) late deaths. Actuarial survival and re-operation-free survival at 109 months were 84.5+/-4.1% and 90.5+/-3.7%, respectively. Freedom from significant aortic stenosis or regurgitation was 78.4+/-5.2% and event-free survival was 64.6+/-5.8%. When compared to rheumatics above 30 years of age, the relative risk of autograft dysfunction was high in the young rheumatics. CONCLUSION: The Ross procedure is not suitable for young patients with rheumatic heart disease. However, it provides acceptable mid-term results in carefully selected older (>30 years) patients with isolated rheumatic aortic valve disease.     

Clinical experience with omniscience and omnicarbon prosthetic heart valves

Omniscience valves were implanted in sixty-two patients. Twenty-eight of these patients underwent aortic valve replacement (AVR), 15 had mitral valve replacement (MVR) and 8 had aortic and mitral valve replacement (DVR). Post-operative events occurred in nine (5.9%/patient year) of the AVR group, in three (1.7%/patient year) of the MVR group and in three (5.4%/patient year) of the DVR group. The actuarial freedom from all events at five years in the AVR, MVR and DVR was 74 +/- 8%, 88 +/- 6%, 67 +/- 16%, respectively. Cardiac death occurred in four (2.5%/patient year) of the AVR, one (0.6%/patient year) of the MVR and two (3.6%/patient year) of the DVR. The freedom at five years in the AVR, MVR and DVR was 88 +/- 6%, 96 +/- 4%, and 77 +/- 14%, respectively. Valve-related complications were noted in four patients. Post-operative cerebral hemorrhage was seen in three of the AVR. Maximum opening angle of the Omniscience valve was 39.1 +/- 4.5 degrees at the aortic position and 44.6 +/- 9.7 degrees at the mitral position. Omnicarbon valves implanted in ninety-five patients, fifty-eight of these patients underwent AVR, 24 had MVR and 13 had DVR. Events occurred post-operatively in four (2.6%/patient year) of the AVR group, in three (12.2%/patient year) of the MVR group, but in none of the DVR group. The freedom at five years was 89 +/- 6% in the AVR and 84 +/- 8% at three years in the MVR. Post-operative cardiac death occurred in one (0.7%/patient year) of the AVR and in two (8.1%/patient year) of the MVR.(ABSTRACT TRUNCATED AT 250 WORDS)     

Failure of Hancock pericardial xenografts: is prophylactic bioprosthetic replacement justified?

The incidence of major valve-related complications was evaluated in a series of patients in whom the Hancock pericardial xenograft was used for aortic (AVR; n = 84), mitral (MVR; n = 17) and mitral-aortic (MAVR; n = 13) valve replacement. At 7 years actuarial survival is 66% +/- 8% after AVR, 64% +/- 13% after MVR, and 41% +/- 15% after MAVR, whereas actuarial freedom from valve-related death is 79% +/- 7% after AVR, 78% +/- 13% after MVR, and 81% +/- 12% after MAVR. Actuarial freedom from thromboemboli and anticoagulant-related hemorrhage at 7 years is 93% +/- 4% and 98% +/- 2% after AVR and 83% +/- 10% and 88% +/- 11% after MVR; no such complications occurred after MAVR. Structural valve deterioration determined at reoperation, at autopsy, or by clinical investigation was observed in 34 patients with AVR (10.0 +/- 0.2%/patient-year), in 10 with MVR (10.6 +/- 3.3%/patient-year), and in 9 with MAVR (16.6 +/- 5.5%/patient-year). After AVR, 19 patients underwent reoperation and 2 died before reoperation; 4 patients with MVR underwent reoperation, and 7 patients with MAVR underwent reoperation and 1 died before reoperation. Seventy-eight percent of the current survivors (13 patients with AVR, 7 with MVR, and 1 with MAVR) have clinical evidence of valve failure. At 7 years actuarial freedom from structural deterioration of the Hancock pericardial xenograft is 25% +/- 7% after AVR, 29% +/- 14% after MVR, and 0% after MAVR.(ABSTRACT TRUNCATED AT 250 WORDS)