Long-Term Follow-up of the St. Jude Medical Prosthesis in Pediatric Patients

Abstract

Background The St. Jude Medical prosthesis has become the most commonly used artificial heart valve, yet few data are available in the pediatric population. This study addresses results of the use of this prosthetic valve in pediatric patients over a 13-year time frame. Methods From January 1982 through June 1994, 73 patients (49 male) underwent 75 valve replacements using the St. Jude Medical prosthesis at Minneapolis Children's Medical Center. Follow-up was complete in 71 patients, with a mean follow-up of 39 ± 32 months (mean ± standard deviation; range, 4 to 142 months). Results Valves’ positions were aortic in 36 patients, mitral or left atrioventricular valve in 34, tricuspid in 1, and double valve in 2. Patient age was 8 ± 6 years, with a range of 1 week to 19 years. Sixteen patients were less than 24 months of age at valve replacement. Prior cardiac procedures had been performed in 82% of mitral patients, 58% of aortic patients, and all of the tricuspid and double-valve patients. Elective valve replacement was performed in 62 of 73 patients (85%). Seven patients (44%) less than 24 months of age had urgent valve replacement; 4 patients (7%) older than 24 months required urgent valve replacement. Overall early mortality was 8% (6 of 73); 36% (4 of 11) in the patients undergoing urgent valve replacement and 3% (2 of 62) in the elective group. All but one of the deaths were due to cardiac dysfunction. There were four late deaths, from 4 to 125 months postoperative, primarily caused by congestive heart failure or pulmonary vascular disease. Cumulative freedom from valve-related events was 93%, 85%, and 77% at 1, 5, and 10 years, respectively. Valve-related complications included thromboembolism (4), bleeding (5), perivalvar leak requiring reoperation (2), transient ischemic attack (1), and endocarditis (1). There have been no permanent strokes or mechanical malfunction. The majority of patients are currently managed with warfarin. Five surviving patients whose initial valve replacement was at age 24 months or younger have undergone repeat valve replacement (42%). Ninety-five percent of patients enjoy good health at follow-up. Conclusions The St. Jude Medical prosthesis offers correction of valvular disease with low morbidity and mortality, and excellent functional result. The St. Jude Medical prosthesis has become the most commonly used artificial heart valve, yet few data are available in the pediatric population. This study addresses results of the use of this prosthetic valve in pediatric patients over a 13-year time frame. From January 1982 through June 1994, 73 patients (49 male) underwent 75 valve replacements using the St. Jude Medical prosthesis at Minneapolis Children's Medical Center. Follow-up was complete in 71 patients, with a mean follow-up of 39 ± 32 months (mean ± standard deviation; range, 4 to 142 months). Valves’ positions were aortic in 36 patients, mitral or left atrioventricular valve in 34, tricuspid in 1, and double valve in 2. Patient age was 8 ± 6 years, with a range of 1 week to 19 years. Sixteen patients were less than 24 months of age at valve replacement. Prior cardiac procedures had been performed in 82% of mitral patients, 58% of aortic patients, and all of the tricuspid and double-valve patients. Elective valve replacement was performed in 62 of 73 patients (85%). Seven patients (44%) less than 24 months of age had urgent valve replacement; 4 patients (7%) older than 24 months required urgent valve replacement. Overall early mortality was 8% (6 of 73); 36% (4 of 11) in the patients undergoing urgent valve replacement and 3% (2 of 62) in the elective group. All but one of the deaths were due to cardiac dysfunction. There were four late deaths, from 4 to 125 months postoperative, primarily caused by congestive heart failure or pulmonary vascular disease. Cumulative freedom from valve-related events was 93%, 85%, and 77% at 1, 5, and 10 years, respectively. Valve-related complications included thromboembolism (4), bleeding (5), perivalvar leak requiring reoperation (2), transient ischemic attack (1), and endocarditis (1). There have been no permanent strokes or mechanical malfunction. The majority of patients are currently managed with warfarin. Five surviving patients whose initial valve replacement was at age 24 months or younger have undergone repeat valve replacement (42%). Ninety-five percent of patients enjoy good health at follow-up. The St. Jude Medical prosthesis offers correction of valvular disease with low morbidity and mortality, and excellent functional result.