The CarboMedics supraannular top hat valve improves prosthesis size in the aortic root

BACKGROUND AND AIM OF THE STUDY: Aortic valve replacement can result in patient-valve mismatch and attenuated left ventricular remodeling. Using CarboMedics mechanical valves, we examined if the supraannular Top Hat prosthesis provided a size advantage over the intraannular valve. METHODS: Seventeen patients with aortic stenosis and aortic root < or = 23 mm were randomized to receive a CarboMedics supraannular Top Hat valve (n = 7) or an intraannular valve (n = 10). Doppler echocardiography was performed preoperatively, and after three months. RESULTS: There was no difference in aortic annulus size, but mean prosthesis size was significantly larger in the Top Hat group than in the intraannular group (25.00 mm versus 21.60 mm); the mean size improvement for Top Hat patients was 3.14 mm. After three months, all patients had excellent functional improvement and low transvalvular pressure gradients, with slightly higher effective valve opening area in the Top Hat group. CONCLUSION: The supraannular Top Hat valve provides an advantage of one to two sizes over the intraannular valve, and improves the effective valve opening area. Both valves offer favorable hemodynamic performance and functional improvement.     

Mid-term results after heart valve replacement with the CarboMedics bileaflet prosthesis: experience with 785 implants.

BACKGROUND: The aim of the study was to evaluate our clinical experience with the CarboMedics Heart Valve Prosthesis. METHODS: Between October 1991 and December 1997, six hundred seventy-two consecutive patients (361 men, 54%; 311 women, 46%; mean age 57 +/- 12 year, range 6-73 years) underwent mechanical valve implantation at the Division of Cardiac Surgery of the University of Verona. Preoperatively, 69% of the patients were in NYHA FC III or IV. Eighty-one patients (12%) had undergone a previous cardiac operation and 14.5% had an ejection fraction less than 35%. We performed an aortic valve replacement in 309 patients (78 valved-conduits for replacement of the entire aortic root), a mitral valve replacement in 250, and a double valve in 113. 52 patients (8%) underwent associated myocardial revascularization. RESULTS: Early mortality was 2.8% (5/309 aortic, 1.6%; 11/250 mitral, 4.4%; 3/113 double, 2.6%). Late mortality was 4.4%. Actuarial survival at 5 years was 89.3% (aortic, 91.1%, mitral 86.4%, double 90.5%). Thromboembolism occurred in 26 patients (3.9%) and major hemorrhagic events in 20 (3%). Nine patients (1.3%) required a reoperation, in 3 cases (0.4%) after endocarditis (Staphylococcus epidermidis). No structural deterioration occurred in our series. CONCLUSION: Our study appears to confirm the safety and reliability of the CarboMedics mechanical valve prosthesis, even in old age groups. This bileaflet prosthesis demonstrates no structural deterioration, a low incidence of complications, and good hemodynamic performance.     

Mid-term results with 1,503 CarboMedics mechanical valve implants

BACKGROUND AND AIM OF THE STUDY: The CarboMedics bileaflet prosthetic heart valve was introduced in 1986, and first implanted by the authors in March 1991. The aim of this study was to analyze the authors' clinical experience with this valve. METHODS: Between March 1991 and October 1998, 1,503 valves were implanted in 1,350 patients (758 males, 592 female; mean age 62 +/- 13 years). Follow up was 99% complete and totaled 4,342 patient-years (pt-yr). Results: The hospital mortality rate was 4.3% (59/1,350). Preoperative NYHA class (p = 0.012), emergency surgery (p = 0.03) and cardiopulmonary bypass time (p = 0.01) were significantly associated with increased risk of operative death (multiple logistic regression). Mean (+/- SEM) survival rates at one and five years were 92.0 +/- 0.7% (n = 1,109) and 80.0 +/- 1.3% (n = 335). Freedom from valve-related complications (linearized rate 5.6%/pt-yr) at one and five years was 89.5 +/- 0.8% (n = 1,031) and 76.3 +/- 1.4% (n = 284). Linearized rates for bleeding events were 2.19%/pt-yr, thromboembolic events 2%/pt-yr, operated valvular endocarditis 0.18%/pt-yr, valve thrombosis 0.14%/pt-yr and non-structural dysfunction 1.22%/pt-yr. Freedom from reoperation at one and five years was 98.5 +/- 0.3% (n = 1,107) and 97.3 +/- 0.5% (n = 334). CONCLUSION: Mid-term results demonstrate that the CarboMedics prosthetic heart valve exhibits a low incidence of valve-related complications.     

Immediate and long-term results of aortic valve replacent with University of Cape Town aortic valve prosthesis

Aortic valve replacement with the University of Cape Town lenticular prosthesis was performed in 149 patients during a six-year period, almost all patients being severely disabled with advanced heart disease.There was a hospital mortality of 12 per cent.Bacterial endocarditis was a serious complication and accounted for three hospital and five long-term deaths. The survivors were followed for periods of up to 72 months (average 24), the minimum period of observation being six months. There were 23 late deaths due to heart disease, of which 5 where due to myocardial failure. Myocardial failure unrelieved or only temporarily alleviated by the operation occurred in three surviving patients.The main problems have been sudden death and systemic embolism. Some of the cases of sudden death were due to coronary artery embolism, but in a number the cause could not be determined even at necropsy, and they were presumed to be due to arrhythmia. Both complications appeared to be related to valve design. A bare steel seat was associated with a high incidence of both complications, whereas a woven Dacron-velour cloth-covered seat almost eliminated embolism and reduced the incidence of sudden death. Long-term anticoagulant therapy appears to be of no real value with the cloth-covered valve.Gratifying results were obtained in the surviving patients with loss of all symptoms in 80 per cent and improvement in almost all patients. This improvement or relief of symptoms was maintained in most patients throughout the period of study.     

Immediate and long-term results of aortic valve replacement with University of Cape Town aortic valve prosthesis

Aortic valve replacement with the University of Cape Town lenticular prosthesis was performed in 149 patients during a six-year period, almost all patients being severely disabled with advanced heart disease.     

Late results of aortic valve replacement with the Starr-Edwards prosthesis.

Details are presented concerning 59 patients who left hospital between January 1964 and January 1969 after aortic valve replacement with the Starr-Edwards prosthesis. Of the 14 late deaths, 7 are known to have been due to causes related to the prosthesis and 4 to other causes. The 45 surviving patients have nearly all shown clinical improvement and only 3 are unable to work as a result of some complication of the operation. Aortic regurgitation and its consequences appear to be the most significant factor leading to symptoms. In 11 of 16 patients with anaemia there was evidence of intravascular haemolysis. The long-term consequence of this complication is not known.     

Late results of aortic valve prosthesis (a clinico-hemodynamic analysis)

Long-term results of aortic-valve ball prosthesis implantation in 184 patients, followed up for about 15 years, are presented. The performance of Soviet-made ball prosthesis in the aortic position has been shown to be fairly satisfactory for a long time. Prostheses of this design are also highly wear-resistant and show satisfactory hydrodynamic properties.     

Fourteen years' experience with the CarboMedics valve in young adults with aortic valve disease

BACKGROUND AND AIM OF THE STUDY: Homografts and the Ross procedure are recommended by many surgeons for aortic valve replacement (AVR) in young adults. The study aim was to monitor patient outcome over a 14-year period after implanting mechanical CarboMedics prosthetic heart valves in young adults with aortic valve disease. METHODS: Between November 1987 and December 2000, 55 patients (42 males, 13 females; median age 33 years; range 15-40 years) each received a CarboMedics valve in the aortic position. All patients were included on a consecutive and non-selected basis. Concomitant surgery was performed in five patients. Anticoagulation was commenced on postoperative day 1. After discharge, patients were followed up by their cardiologist or general practitioner using questionnaires and telephone calls. Actuarial estimates of survival and freedom from morbid events were calculated using the Kaplan-Meier method. RESULTS: No patient died during surgery. Complete follow up data were available for all patients; total follow up was 404 patient-years (pt-yr). The 30-day mortality rate was zero. Actuarial survival at 14 years was 90 +/- 4.9%, and actuarial freedom from all valve-related events 92 +/- 3.7%. No valve thrombosis or major bleeding events were identified. Linearized rates per 100 pt-yr were: embolism 0.25; paravalvular leakage 0.25; prosthetic endocarditis 0.25; and reoperation 0.50. There was no hemolysis, prosthetic valve dysfunction, or structural deterioration. CONCLUSION: Over a 14-year period, implantation of the CarboMedics prosthetic heart valve has proven to be an excellent solution for AVR in young adults with aortic valve disease.     

CarboMedics mechanical prosthesis: performance at eight years

BACKGROUND AND AIM OF THE STUDY: The bileaflet St. Jude Medical mechanical prosthesis has been implanted for over 20 years. The purpose of this study was to evaluate the clinical performance of the bileaflet CarboMedics (CM) prosthesis, which was introduced in 1986. METHODS: The CM prosthesis was implanted in 1,258 patients (709 males, 549 females; mean age 60.9 +/- 12.3 years) between 1989 and 1997. The prosthesis distribution was aortic valve replacement (AVR) 613; mitral valve replacement (MVR) 447; and multiple replacement (MR) 231. Coronary artery bypass (CAB) was performed in 334 (26.6%) patients; previous procedures had been performed in 346 (27.5%). The age distribution was <60 years (n = 527), 61-70 years (n = 424) and >70 years (n = 307). Risk factors assessed were age or age groups, gender, CAB, previous surgery, rhythm, valve position, status and NYHA functional class. The total follow up was 4,765.0 patient-years (pt-yr), and was 98.4% complete. RESULTS: The early mortality rate was 5.6% (AVR 4.8%, MVR 3.7%, MR 11.5%). The late mortality rate was 3.7%/pt-yr (n = 174), and valve-related mortality 1.1%/pt-yr (n = 50). The total thromboembolism (TE) rate was 4.1%/pt-yr (n = 195) (p = NS by valve position); the major TE rate was 1.9%/pt-yr and fatal TE rate 0.31%/pt-yr (n = 15). The valve thrombosis rate was 0.31%/pt-yr (n = 15; 11 MVR, four MR). The fatal thrombosis rate was 0.06%/pt-yr (n = 3; two MVR, one MR). The hemorrhage rate was 2.7%/pt-yr (n = 128) and fatal hemorrhage rate 0.4%/pt-yr (n = 20). The reoperation rate was 1.0%/pt-yr (n = 46), fatal 0.1%/pt-yr (n = 5). The actuarial freedom from overall TE at eight years was 77.3 +/- 2.8%; major TE 88.5 +/- 1.6%, and hemorrhage 76.4 +/- 3.2% (all p = NS by valve position). There were no independent predictors of overall TE and TE exclusion of early events. The only predictor for TE major was status (emergency > urgent > elective). The actuarial freedom from valve-related mortality at eight years was 91.4 +/- 1.8% (p = NS by position) (actual freedom 93.0 +/- 1.3%). The actuarial freedom from valve-related reoperation was 91.1 +/- 2.4% (p <0.05; AVR > MVR and MR, MVR > MR) (actual freedom 92.2 +/- 2.7%). Overall survival rate at eight years was 68.2 +/- 2.3% (p <0.05; AVR > MVR and MR, MVR > MR). CONCLUSION: The clinical performance of the CarboMedics mechanical prosthesis is satisfactory when implanted in the mitral, aortic and multiple positions.     

Remote results of aortic valve replacement with the St. Jude medical prosthesis

The St Jude Medical prosthesis on the aortic valve was evaluated in a 7-year prospective study which involved 49 patients. Survivors were followed up for 2,577 patient-months, meaning a mean follow-up of 5 years per patient and a minimum follow-up of 4 years per patient. The overall survival rate at 6 years was 79.6 +/- 5.7 p. 100. All deaths occurred during the first two years, and none of them was ascribable to the prosthesis. The left ventricular systolic and diastolic echocardiographic diameters were significantly greater in the patients who died. The linear rate of thromboembolic accidents was 0.93 p. 100 per patient-year, and that of accidents due to anticoagulants was 3.26 p. 100 per patient-year. The probability of freedom from all complication at 6 years was 71 +/- 9 p. 100. In the totality of patients, 10.2 p. 100 required pacemaker implantation; these patients had aortic stenosis exclusively, and all were alive at 7 years. The quality of live, assessed during consultations, was altered in one-half of the survivors. The good results obtained with the St Jude Medical prosthesis are marred by a high initial mortality rate, notably in patients with left ventricular enlargement, by the frequency of accidents due to anticoagulants and by the mediocre quality of life of survivors.     

The CarboMedics prosthetic heart valve: experience with 1,084 implants

BACKGROUND AND AIM OF THE STUDY: The study aim was to evaluate our clinical experience with the CarboMedics heart valve prosthesis. METHODS: Between October 1991 and December 2000, 942 consecutive patients (514 males, 428 females; mean age 58+/-11 years; range: 6-78 years) underwent mechanical valve implantation with the CarboMedics prosthesis. Preoperatively, 47% of patients were in NYHA class III and 22% in class IV; in addition, 134 patients (14.2%) had undergone a previous cardiac operation. Aortic valve replacement (AVR) was performed in 469 patients (49.8%), mitral valve replacement (MVR) in 330 (35.0%), double valve replacement (DVR) in 142 (15.1%), and isolated tricuspid valve replacement (TVR) in one patient. Eighty-eight patients (9.3%) underwent associated myocardial revascularization. Mean cardiopulmonary bypass and aortic cross-clamp times for the entire group were 107+/-39 min and 74+/-24 min, respectively. RESULTS: Overall early mortality was 2.3% (6/469 AVR, 1.2%; 12/330 MVR, 3.6%; 4/142 DVR, 2.8%). Late mortality was 3.1% (n = 29; including 17 cardiac deaths (10 were valve-related). Mean follow up was 66+/-31 months (range: 1-109 months), and was 98% complete yielding a total follow up of 4959 years. Actuarial survival at five years for the entire group was 89.3+/-1.6% (AVR 91.1%, MVR 86.4%, DVR 90.5%). Thromboembolism occurred in 26 patients (2.8%, 0.52%/pt-year) and major hemorrhagic events in 20 (2.1%, 0.4%/pt-year). Nine patients (0.9%) required a reoperation, in three cases (0.3%) after Staphylococcus epidermidis-mediated endocarditis. No structural deterioration occurred. Among 891 survivors, 94% of the patients are currently in NYHA classes I or II (p <0.05). CONCLUSION: This study confirmed the safety and reliability of the CarboMedics mechanical valve prosthesis, even in old age groups. This bileaflet prosthesis showed no structural deterioration, and a low incidence of overall complications.