1. Infective endocarditis after transcatheter pulmonary valve replacement using the Melody valve: combined results of 3 prospective North American and European studies.
- Author
-
McElhinney DB, Benson LN, Eicken A, Kreutzer J, Padera RF, and Zahn EM
- Subjects
- Adolescent, Adult, Anti-Bacterial Agents therapeutic use, Cardiac Catheterization mortality, Child, Endocarditis, Bacterial diagnosis, Endocarditis, Bacterial drug therapy, Endocarditis, Bacterial microbiology, Endocarditis, Bacterial mortality, Europe, Female, Heart Defects, Congenital surgery, Heart Valve Prosthesis Implantation methods, Heart Valve Prosthesis Implantation mortality, Humans, Kaplan-Meier Estimate, Male, Middle Aged, North America, Prospective Studies, Prosthesis Design, Prosthesis-Related Infections diagnosis, Prosthesis-Related Infections drug therapy, Prosthesis-Related Infections microbiology, Prosthesis-Related Infections mortality, Pulmonary Valve Insufficiency diagnosis, Pulmonary Valve Insufficiency etiology, Pulmonary Valve Stenosis diagnosis, Pulmonary Valve Stenosis etiology, Recurrence, Risk Factors, Time Factors, Treatment Outcome, Young Adult, Cardiac Catheterization adverse effects, Cardiac Catheterization instrumentation, Endocarditis, Bacterial etiology, Heart Valve Prosthesis adverse effects, Heart Valve Prosthesis Implantation adverse effects, Heart Valve Prosthesis Implantation instrumentation, Prosthesis-Related Infections etiology, Pulmonary Valve Insufficiency therapy, Pulmonary Valve Stenosis therapy
- Abstract
Background: Transcatheter (percutaneous) pulmonary valve (TPV) replacement has emerged as a viable therapy for right ventricular outflow tract conduit dysfunction. Little is known about the incidence, clinical course, and outcome of infective endocarditis (IE) after TPV implant. We reviewed combined data from 3 ongoing prospective multicenter trials to evaluate the experience with IE among patients undergoing TPV replacement using the Melody valve., Methods and Results: Any clinical episode reported by investigators as IE with documented positive blood cultures and fever, regardless of TPV involvement, was considered IE. Cases were classified as TPV-related if there was evidence of vegetations on or new dysfunction of the TPV. The 3 trials included 311 patients followed for 687.1 patient-years (median, 2.5 years). Sixteen patients were diagnosed with IE 50 days to 4.7 years after TPV implant (median, 1.3 years), including 6 who met criteria for TPV-related IE: 3 with vegetations, 2 with TPV dysfunction, and 1 with both. The annualized rate of a first episode of IE was 2.4% per patient-year and of TPV-related IE was 0.88% per patient-year. Freedom from TPV-related IE was 97±1% 4 years after implant. All patients were treated with intravenous antibiotics, 4 had the valve explanted, and 2 received a second TPV. There was 1 sepsis-related death, 1 patient died of sudden hemoptysis, and 2 patients developed recurrent IE., Conclusions: Bacterial endocarditis has occurred in all 3 prospective multicenter studies of the Melody valve in North America and Europe. Most cases did not involve the TPV and responded to antibiotics. More data are necessary to understand risk factors in this population.
- Published
- 2013
- Full Text
- View/download PDF