J Craver1. 1. Emory University Clinic, Atlanta, GA 30322, USA.
Abstract
INTRODUCTION: The CarboMedics Prosthetic Heart Valve has been in use since 1986, with more than 220,000 valves implanted through August of 1997 in more than 1550 centers in more than 100 countries. This paper presents the results of a multicenter, international clinical trial that has spanned 10 years. METHODS: There were 1128 valves implanted in patients at 10 sites. The mean follow-up for patients was 4.5 years, with a total of 5110.1 patient-years. Approximately one-third of the patients came from the United States, one-third from Canada, and one-third from Scandinavia. The mean age was 57.2 years; 54.8% were men and 45.2% were women. The primary disease was calcification/atherosclerosis in 37% of the patients and rheumatic disease in 32.7%, and reoperation accounted for 17.5%. There were 556 aortic valve replacements, 428 mitral valve replacements, 139 double valve replacements, and five tricuspid replacements. RESULTS: The survival rate of all implanted patients was 79% at 5 years postoperatively. The survival rate in redo valve patients was as good as the primary survival rate; the survival rate in double valve patients was not as good as the survival rate in single valve patients. There was no structural failure of the valve. Patient outcome as described by New York Heart Association class was significantly improved throughout the postoperative period. Rates of freedom from thrombosis, thromboembolism, and hemorrhage at 5 years were 98.9%, 90%, and 91%, respectively. SUMMARY: Clinical results of the CarboMedics Prosthetic Heart Valve in a midterm, multicenter study were excellent, with low rates of morbidity and mortality and no structural failure.
INTRODUCTION: The CarboMedics Prosthetic Heart Valve has been in use since 1986, with more than 220,000 valves implanted through August of 1997 in more than 1550 centers in more than 100 countries. This paper presents the results of a multicenter, international clinical trial that has spanned 10 years. METHODS: There were 1128 valves implanted in patients at 10 sites. The mean follow-up for patients was 4.5 years, with a total of 5110.1 patient-years. Approximately one-third of the patients came from the United States, one-third from Canada, and one-third from Scandinavia. The mean age was 57.2 years; 54.8% were men and 45.2% were women. The primary disease was calcification/atherosclerosis in 37% of the patients and rheumatic disease in 32.7%, and reoperation accounted for 17.5%. There were 556 aortic valve replacements, 428 mitral valve replacements, 139 double valve replacements, and five tricuspid replacements. RESULTS: The survival rate of all implanted patients was 79% at 5 years postoperatively. The survival rate in redo valve patients was as good as the primary survival rate; the survival rate in double valve patients was not as good as the survival rate in single valve patients. There was no structural failure of the valve. Patient outcome as described by New York Heart Association class was significantly improved throughout the postoperative period. Rates of freedom from thrombosis, thromboembolism, and hemorrhage at 5 years were 98.9%, 90%, and 91%, respectively. SUMMARY: Clinical results of the CarboMedics Prosthetic Heart Valve in a midterm, multicenter study were excellent, with low rates of morbidity and mortality and no structural failure.