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Infective endocarditis after transcatheter pulmonary valve replacement using the Melody valve: combined results of 3 prospective North American and European studies.
Circ Cardiovasc Interv. 2013 Jun; 6(3):292-300.CC

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.

Authors+Show Affiliations

New York University Langone Medical Center, New York, NY, USA.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial
Journal Article
Multicenter Study

Language

eng

PubMed ID

23735475

Citation

McElhinney, Doff B., et al. "Infective Endocarditis After Transcatheter Pulmonary Valve Replacement Using the Melody Valve: Combined Results of 3 Prospective North American and European Studies." Circulation. Cardiovascular Interventions, vol. 6, no. 3, 2013, pp. 292-300.
McElhinney DB, Benson LN, Eicken A, et al. Infective endocarditis after transcatheter pulmonary valve replacement using the Melody valve: combined results of 3 prospective North American and European studies. Circ Cardiovasc Interv. 2013;6(3):292-300.
McElhinney, D. B., Benson, L. N., Eicken, A., Kreutzer, J., Padera, R. F., & Zahn, E. M. (2013). Infective endocarditis after transcatheter pulmonary valve replacement using the Melody valve: combined results of 3 prospective North American and European studies. Circulation. Cardiovascular Interventions, 6(3), 292-300. https://doi.org/10.1161/CIRCINTERVENTIONS.112.000087
McElhinney DB, et al. Infective Endocarditis After Transcatheter Pulmonary Valve Replacement Using the Melody Valve: Combined Results of 3 Prospective North American and European Studies. Circ Cardiovasc Interv. 2013;6(3):292-300. PubMed PMID: 23735475.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Infective endocarditis after transcatheter pulmonary valve replacement using the Melody valve: combined results of 3 prospective North American and European studies. AU - McElhinney,Doff B, AU - Benson,Lee N, AU - Eicken,Andreas, AU - Kreutzer,Jacqueline, AU - Padera,Robert F, AU - Zahn,Evan M, Y1 - 2013/06/04/ PY - 2013/6/6/entrez PY - 2013/6/6/pubmed PY - 2014/1/24/medline KW - Ross procedure KW - endocarditis KW - pulmonary regurgitation KW - pulmonary stenosis KW - pulmonary valve KW - tetralogy of Fallot SP - 292 EP - 300 JF - Circulation. Cardiovascular interventions JO - Circ Cardiovasc Interv VL - 6 IS - 3 N2 - 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. SN - 1941-7632 UR - https://www.unboundmedicine.com/medline/citation/23735475/Infective_endocarditis_after_transcatheter_pulmonary_valve_replacement_using_the_Melody_valve:_combined_results_of_3_prospective_North_American_and_European_studies_ L2 - https://www.ahajournals.org/doi/10.1161/CIRCINTERVENTIONS.112.000087?url_ver=Z39.88-2003&rfr_id=ori:rid:crossref.org&rfr_dat=cr_pub=pubmed DB - PRIME DP - Unbound Medicine ER -