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.     

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.     

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

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

Cardiac valve replacement with glutaraldehyde preserved aortic allografts

From September 1984 to December 1988, 144 patients underwent cardiac valve replacement using glutaraldehyde preserved stent mounted aortic allografts. The mean age was 21.4 years (54.9% were 15 years old or younger). The mitral valve was replaced in 125 patients, the aortic valve in 7, the pulmonary valve in 3, the tricuspid in 1, the mitral and tricuspid in 1, and the aortic and mitral in 7. Hospital mortality was 2.8% (4 patients). Total follow-up was 396.3 patient-years and the mean follow-up was 2.8 years per patient. The 5-year actuarial survival was 73.8% +/- 11.9%. The 4-year actuarial survival for patients aged 15 or younger was 81.4% +/- 7.1%. The overall mortality was 2.8% +/- 0.8%/per patient-year. The incidence of valve-related complications was 4.8% +/- 1.1%/per patient-year, and the calcification rate was 3.0% +/- 0.9%/per patient-year and was the main complication reported in 12 patients, all under the age of 15 years. It occurred 14-47 months after implantation (mean 32.7 months). Five-year actuarial freedom from valve dysfunction due to calcification was 82.6% +/- 5.0% and for patients aged 15 or younger was 69.9% +/- 8.8%. The incidence of reoperation was 3.3% +/- 0.9%/per patient-year. These initial results demonstrate a 5-year actuarial freedom from primary valve failure due to fibrocalcification superior to the results obtained with xenobioprostheses in the paediatric age group.     

Long term results of cardiac valve replacement in patients aged 75 years and older.

From June 1978 to December 1989, 158 patients over 75 years of age (mean: 78 years; range 75 to 86 years) underwent 164 valve replacements: 134 in the aortic, 18 in the mitral and 6 in double mitral and aortic positions. One hundred and seven of these valves (66%) were bioprostheses, 93 aortic and 14 mitral and 57 valves (34%) were mechanical prostheses; 47 aortic and 10 mitral. Hospital mortality (less than or equal to 30 days) was 7% (11 patients, all in NYHA class III or IV) but was higher in patients who had undergone associated procedures (9.8%; 6/61 patients) or in patients who had mitral valve replacements (11%) and in double valve replacement (16.6%). Because of a minimal delay of one year, long term follow-up information (100%) was only obtained from the first 110 patients discharged from hospital. Late mortality has been 13.6% and actuarial survival at 11 years was 71.5% +/- 5. Therefore, despite a hospital mortality of more than twice that of patients operated upon under 75 years of age (3.3%), an actuarial survival at 11 years, similar to that of patients under 75 years (77 +/- 5%) and the functional improvement obtained (95% of survivors are NYHA class I or II) certainly justify surgery in these patients. Because of the incidence of anticoagulant related hemorrhages in these patients (1.7% patient year) and since, structural deterioration of the bioprostheses was non existent in this series, a bioprosthesis appears to be the best valvular substitute in patients over 75 years of age.     

Valve replacement in patients over 80 years of age]

Between January 1983 and October 1990, 20 patients age 80 years or older (mean 82 +/- 1.5 year, range 80 to 87 years) underwent valvular surgery at Clinic for Cardiovascular Surgery Zurich. The indication for operation was aortic stenosis in 19 patients, and mitral insufficiency after previous mitral valve replacement with a bioprosthesis in one. There were 15 elective operations, 2 urgent, and 3 emergency operations. Four of these patients had aortic valve replacement plus coronary artery bypass grafting. The operative mortality rate was 15% (3 patients). All patients were preoperative in NYHA classes III and IV. All survivors remained in NYHA classes I or II. The survivors have been followed from 6 to 70 months (mean 20 +/- 8 months). The actuarial survival rate at 1 and 5 years was 78.5% and 67%, respectively. Valvular replacement can be performed with increased but acceptable mortality and morbidity. Long-term results are encouraging.     

The Ionescu-Shiley pericardial valve: results in 473 patients

From January 1, 1980, through December 31, 1985, 473 patients underwent valve replacement with an Ionescu-Shiley valve. Overall hospital mortality was 7.8%. Major associated procedures and preoperative New York Heart Association (NYHA) Classes IV and V influenced hospital mortality significantly. The mean follow-up was 2.6 +/- 1.3 years. Late mortality was 5.9%. Overall actuarial survival was 81% at 5 years. A chief cause of reoperation was cusp rupture of a mitral prosthesis in 5 patients (all after aortic and mitral valve replacement). The overall actuarial reoperation-free incidence was 93% at 5 years. Thromboembolic (TB) phenomena occurred at a linear incidence of 1.4 +/- 0.3% per patient-year or an actuarial thromboembolism-free incidence of 92% at 5 years. Univariate and multivariate analyses showed that postoperative NYHA Class, rhythm at follow-up, and anticoagulant therapy significantly influenced the incidence of TE phenomena.     

The Medtronic-Hall cardiac valve: 7 1/2 years' clinical experience

Clinical information on the Medtronic-Hall valve prosthesis was obtained by reviewing the records of 379 patients, 164 of whom had aortic valve replacement (AVR), 163 of whom had mitral valve replacement (MVR), and 52 of whom had double valve replacement over 90 months (1,225 patient-years) (mean follow-up, 42.01 +/- 1.3 months [+/- standard error]). Mean age was 53.8 +/- 12 years. One hundred ninety-three patients (50.9%) had some type of concomitant operation, such as tricuspid annuloplasty, coronary artery bypass grafting, or resection of ascending aortic aneurysm. Ninety-one percent were in New York Heart Association (NYHA) Functional Class III or IV preoperatively. Early mortality and late mortality were 7.7% (29 patients) and 13.5% (51 patients), respectively. The actuarial survival at 7 1/2 years was 74.1 +/- 2.7% for the total group and 69.0 +/- 4.5% for those having AVR, 81.0 +/- 3.2% for those having MVR, and 67.0 +/- 8.9% for those having double valve replacement. All patients but 2 were maintained on a regimen of chronic anticoagulation with warfarin sodium. Twenty-six thromboembolic episodes occurred (2.1/100 patient-years): 13 after MVR (2.3/100 patient-years), 11 after AVR (2.1/100 patient-years), and 2 after double valve replacement (1.4/100 patient-years). Four thromboembolic episodes were fatal; no valve thrombosis occurred. There were no structural failures. Of the 350 late survivors, 92% were in NYHA Functional Classes I and II. Total valve-related complications have been minimal.(ABSTRACT TRUNCATED AT 250 WORDS)     

Excellent durability of the Hancock porcine bioprosthesis in the tricuspid position. A sixteen-year follow-up study.

From February 1975 to August 1981, 23 consecutive patients underwent tricuspid valve replacement, which was either isolated (six patients) or combined with the replacement of other valves (17) by means of a standard, glutaraldehyde-preserved Hancock porcine bioprostheses. Patients' ages ranged from 9 to 53 (mean 36.2) years. The follow-up period ranged from 0.2 to 16.5 years (mean 9.1) and was complete in 100% of all cases. Structural valve failure of the tricuspid Hancock valve was noticed in two patients, a 9-year-old boy and a 13-year-old girl 3.4 and 16.5 years after implantation, respectively. The actuarial freedom rate from structural valve failure at 10 years was 94 +/- 6%. There were six tricuspid prosthesis-related events: structural valve failure in two and valve thrombosis, anticoagulant-related bleeding, prosthetic valve endocarditis, and periprosthetic leak in one each, respectively. The actuarial freedom from these events at 10 years was 78 +/- 10%. Five pairs of aortic/mitral-tricuspid Hancock valves were explanted simultaneously from the same patients after 8.1 to 13.9 (mean 11.4) years postoperatively. A gross examination showed no valve dysfunction in the explants from the tricuspid position, but degenerative changes with valve dysfunction in those from the mitral and aortic position were observed (none of five versus five of seven; p < 0.03). We concluded that the selection of a Hancock bioprosthesis in the tricuspid position is acceptable because of the low incidence of prosthesis-related complications and the excellent durability of more than 10 years.     

Long-term performance of the Hancock porcine bioprosthesis in the tricuspid position. A review of forty-five patients with fourteen-year follow-up

Because little information is available regarding the clinical performance of the Hancock porcine bioprosthesis (Johnson & Johnson Cardiovascular, King of Prussia, Pa.) implanted in the tricuspid position, we reviewed the long-term follow-up of patients who had tricuspid valve replacement with this device. From March 1970 to December 1983, 45 patients had tricuspid valve replacement, either isolated (seven patients) or combined with replacement of other valves (38 patients) by means of a standard, glutaraldehyde-preserved Hancock porcine bioprosthesis. Follow-up ranged from 0.2 to 14.7 years (mean, 7.6 +/- 3.6 years) and was complete. The late mortality rate was 6.6% +/- 1.6%/pt-yr and the actuarial survival rate at 14 years was 23% +/- 9%. Reoperation because of structural deterioration of the tricuspid, the mitral, or both bioprostheses was performed in nine patients (3.7% +/- 1.2%/pt-yr) from 40 to 177 months (mean, 112 +/- 43 months) and resulted in no deaths. Actuarial freedom from structural deterioration of a Hancock tricuspid porcine bioprosthesis at 14 years is 68% +/- 13%. Morphologic examination of explanted porcine bioprostheses showed that those implanted in the tricuspid position had lower degrees of calcification and less severe structural changes than those simultaneously explanted from the mitral position. We conclude that the Hancock porcine bioprosthesis has an acceptable long-term durability and satisfactory performance after tricuspid valve replacement, and we continue to favor its use in the tricuspid position even in association with mechanical prostheses in the left side of the heart.     

Twenty-year experience with the St Jude Medical mechanical valve prosthesis

BACKGROUND: We have prospectively followed all adult St Jude Medical mechanical valve recipients at the Medical University of South Carolina since the initial implant in January 1979 and now present our 20-year experience. METHODS: We prospectively followed 837 valve recipients (aortic valve replacement; n = 478; mitral valve replacement; n = 359) from January 1979 to December 2000 at 12-month intervals. RESULTS: Ages ranged from 19 to 84 years. Follow-up averaged (mean +/- standard deviation) 7 +/- 5 years (98% complete). Patients were in New York Heart Association class III or IV in 77% (aortic valve replacement) and 89% (mitral valve replacement) preoperatively. A 19-mm valve was implanted in 15.5% of aortic valve replacement patients. Coronary bypass was required in 31% of aortic valve replacements and 20% of mitral valve replacements. Operative mortality was 17/478 (3.6%) in aortic valve replacement and 19/359 (5.3%) in mitral valve replacement, and multivariable predictors were 19-mm valve size, 3 or more coronary bypass grafts, and New York Heart Association class IV for aortic valve replacement and New York Heart Association class IV and age for mitral valve replacement. Actuarial survivorship at 10 and 20 years was 57% +/- 3% and 26% +/- 5% for aortic valve replacement and 61% +/- 3% and 39% +/- 4% for mitral valve replacement. Multivariable predictors of late death were African-American ethnicity, New York Heart Association class III or IV, coronary bypass, and age for aortic valve replacement and New York Heart Association class III or IV, coronary bypass, and age for mitral valve replacement. For aortic valve replacement, effective orifice area was univariately (P =.002) but not multivariately (P =.378) predictive of late death. Structural valve deterioration was not observed. For aortic valve replacement, actuarial freedom (at 10 and 20 years) from reoperation was 93% +/- 1% and 90% +/- 2%; thromboembolism, 82% +/- 3% and 68% +/- 8%; bleeding events, 77% +/- 3% and 66% +/- 6%; prosthetic valve endocarditis, 94% +/- 1% and 94% +/- 1%; valve-related mortality, 94% +/- 2% and 86% +/- 4%; and valve-related mortality or morbidity, 58% +/- 3% and 32% +/- 8%. For mitral valve replacement, actuarial freedom (at 10 and 20 years) from reoperation was 96% +/- 1% and 90% +/- 3%; thromboembolism, 77% +/- 3% and 59% +/- 7%; bleeding events, 86% +/- 2% and 65% +/- 8%; prosthetic valve endocarditis, 98% +/- 1% and 96% +/- 2%; valve-related mortality, 89% +/- 0.2% and 74% +/- 8%; and valve-related mortality or morbidity, 63% +/- 3% and 29% +/- 7%. CONCLUSIONS: After 2 decades of observation with close follow-up, the St Jude Medical mechanical valve continues to be a reliable prosthesis.     

Tricuspid valve involvement in combined mitral and aortic valve surgery.

BACKGROUND: Combined mitral and aortic valve disease requiring surgery may involve the tricuspid valve as well. Our treatment policy is conservative especially for tricuspid regurgitation which is operated on when severe only. METHODS: A retrospective study was performed at a tertiary and secondary referral center for cardiovascular disease. Over a 15-year period, 65 consecutive patients underwent aortic and mitral surgery with concomitant tricuspid regurgitation and/or stenosis. Fifty-five/65 (85%) patients were in NYHA class III-IV. Fifty-eight/65 (89%) patients had tricuspid regurgitation secondary to right chamber dilatation and 7/65 (11%) had tricuspid stenosis and/or regurgitation because of previous endocarditis. Twenty-two/65 (34%) tricuspid valves were operated on: 18/22 (82%) de Vega annuloplasty, 2/22 (9%) commissurotomies and 2/22 (9%) prosthetic valves. Mortality and complications were recorded during a mean follow-up of 5.3 yrs (range, 6 months-15.3 yrs). Event-free survivals were determined using the Kaplan-Meier method. RESULTS: Hospital mortality was 6.2% (4/65) and the complication rate was 18.5% (12/65). The freedom from late valve related mortality and morbidity at 5, 10 and 15 years was 86+/-5.5%, 81.9+/-6.8%, and 81.9+/-6.8% respectively. One valve related complication was due to the tricuspid valve. At last follow-up, 87% (47/54) of the survivors were in NYHA class I-II. CONCLUSIONS: With a conservative policy of tricuspid valve intervention, functional results of this patient population are good and long-term valve related morbidity and mortality are mainly related to the mitral and aortic valve procedures.     

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)     

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.     

Surgical management of multivalvular heart disease

Background This study of patients with multivalvular lesions was undertaken to assess optimal surgical management and identify risk factors for prognosis. Methods Five hundred and twenty one patients underwent valve repair or replacement surgery between January’90 and December’98. Mean age was 30.19±12.2 years and 342 were males. All patients had dyspnoea on exertion, 467 (89.6%) were in New York Heart Association (NYHA) Class III and 47 (9.0%) were in Class IV. Congestive Heart Failure in 67 (12.3%) and prior cardiac procedure in 66 (12.2%) were other risk factors. The valves affected were mitral and aortic in 483 (Group 1), mitral and tricuspid in 43 (Group II) and mitral, aortic and tricuspid in 40 (Group III) patients. Surgical procedures included, several different combinations using repair or replacement with prosthetic or biological substitutes. Results Operative mortality was 9.8% (51 patients). Follow up (1 to 108 months, mean 45 months) was 94% complete. Late mortality occurred in 48 patients (10.4%). Causes included, left ventricular dysfunction (n=21), valve thrombosis (n=10) and, endocarditis (n=8). Freedom from late events was 50.7±8.5% at 9 years. At their last visit 40 patients were in Class IV, 18 were in Class III, 59 in Class II and the remaining in Class I (NYHA). Conclusions Important predictors of early mortality were NYHA Class IV, congestive heart failure, tricuspid valve disease and prior cardiac surgery. Left ventricular dysfunction was an important determinant of late outcome.     

Eight year experience with the CarboMedics bileaflet valvular prosthesis.

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

Long-term experience with the Sorin Bicarbon and Edwards Mira mechanical valve prostheses in the mitral position

OBJECTIVE: Sorin Bicarbon (SB) and Edwards Mira (EM) valves have an identical mechanical design but different sewing cuffs. The purpose of this retrospective study was to analyze the long-term clinical and echocardiographic outcomes after mitral valve replacement with these two valves in a combined population of patients. METHODS: We retrospectively reviewed records of 73 patients who underwent mitral valve replacement using SB (n = 19) or EM (n = 54) valves. Preoperatively, 49 patients (68.1%) were in New York Heart Association (NYHA) functional class III or IV. Concomitant procedures were performed in 52 patients (71.2%). Early and late postoperative echocardiography was performed in 69 and 57 patients, respectively. RESULTS: Operative mortality was 4.1%, and early morbidity was 9.6%. Overall patient survival at 9 years was 85.1% +/- 4.8%. Actuarial freedom from valve-related death was 95.4% +/- 2.6% at 9 years. As shown by Doppler echocardiography, the early and late mean transprosthetic pressure gradients were 3.4 +/- 1.4 mmHg and 3.8 +/- 2.1 mmHg, respectively. At the end of follow-up, 98.4% of survivors were in NYHA class I or II. CONCLUSION: The Sorin Bicarbon and, Edwards Mira mechanical valves in the mitral position provide satisfactory long-term clinical and echocardiographic performance.     

Late results of heart valve replacement with the Hancock II bioprosthesis

OBJECTIVE: To review the late clinical outcomes of patients who had isolated aortic or mitral valve replacement with the Hancock II bioprosthesis. METHODS: From 1982 to 1994, 670 patients underwent isolated aortic valve replacement and 310 underwent isolated mitral valve replacement with the Hancock II bioprosthesis (Medtronic Inc, Minneapolis, Minn). Mean age was 65 +/- 12 years in both groups. Most patients were in New York Heart Association functional classes III or IV, and concomitant coronary artery disease was present in 44% of patients in the aortic valve group and 41% of patients in the mitral valve group. Patients were followed up prospectively at periodic intervals. Mean follow-up was 87 +/- 45 months in the aortic valve group and 83 +/- 50 months in the mitral valve group, and it was 99% complete. RESULTS: Actuarial survival at 15 years was 47% +/- 3% in the aortic valve group and 30% +/- 5% in the mitral valve group. Older age, advanced functional class, impaired left ventricular function, active endocarditis, and coronary artery disease were independent predictors of late death. The freedom from thromboembolic complications at 15 years was 83% +/- 3% in the aortic and 87% +/- 3% in the mitral valve group. The freedom from infective endocarditis at 15 years was 96% +/- 1% in the aortic and 91% +/- 1% in the mitral valve group. At 15 years, the actuarial and actual freedom from structural valve deterioration was 81% +/- 5% and 90% +/- 3%, respectively, in the aortic group and 66% +/- 6% and 83% +/- 3%, respectively, in the mitral group. Younger age, mitral valve position, and poor ventricular function were independent predictors of structural valve deterioration. The freedom from repeat valve replacement at 15 years was 77% +/- 5% in the aortic group and 69% +/- 6% in the mitral. The vast majority of patients had functional improvement after valve replacement. CONCLUSIONS: The Hancock II bioprosthesis has provided good clinical outcomes and is a durable valve, particularly in the aortic position in older patients.     

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

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

Heart valve replacement with the Sorin tilting-disc prosthesis. A 10-year experience.

From 1978 to 1988, 697 patients with a mean age of 48 +/- 11 years (range 5 to 75 years) received a Sorin tilting-disc prosthesis; 358 had had aortic valve replacement, 247 mitral valve replacement, and 92 mitral and aortic valve replacement. Operative mortality rates were 7.8%, 11.3%, and 10.8%, respectively, in the three groups. Cumulative duration of follow-up is 1650 patient-years for aortic valve replacement (maximum follow-up 11.4 years), 963 patient-years for mitral valve replacement (maximum follow-up 9.9 years) and 328 patient-years for mitral and aortic valve replacement (maximum follow-up 9.4 years). Actuarial survival at 9 years is 72% +/- 4% after mitral valve replacement, 70% +/- 3% after aortic valve replacement, and 50% +/- 12% after mitral and aortic valve replacement, and actuarial freedom from valve-related deaths is 97% +/- 2% after mitral valve replacement, 92% +/- 2% after aortic valve replacement, and 62% +/- 15% after mitral and aortic valve replacement. Thromboembolic events occurred in 21 patients with aortic valve replacement (1.3% +/- 0.2%/pt-yr), in 12 with mitral valve replacement (1.2% +/- 0.3% pt-yr), and in seven with mitral and aortic valve replacement (2.1% +/- 0.8%), with one case of prosthetic thrombosis in each group; actuarial freedom from thromboembolism at 9 years is 92% +/- 3% after mitral valve replacement, 91% +/- 3% after aortic valve replacement, and 74% +/- 16% after mitral and aortic valve replacement. Anticoagulant-related hemorrhage was observed in 15 patients after aortic valve replacement (0.9% +/- 0.2%/pt-yr), in 9 after mitral valve replacement (0.9% +/- 0.3%/pt-yr), and in 6 with mitral and aortic valve replacement (0.9% +/- 0.5%/pt-yr); actuarial freedom from this complication at 9 years is 94% +/- 2% after aortic valve replacement, 91% +/- 4% after mitral valve replacement, and 68% +/- 16% after mitral and aortic valve replacement. Actuarial freedom from reoperation at 9 years is 97% +/- 2% after mitral and aortic valve replacement, 92% +/- 4% after mitral valve replacement, and 89% +/- 3% after aortic valve replacement, with no cases of mechanical fracture. The Sorin valve has shown a satisfactory long-term overall performance, comparable with other mechanical prostheses, and an excellent durability that renders it a reliable heart valve substitute for the mitral and aortic positions.