Endocarditis After Transcatheter Pulmonary Valve Replacement

Doff B McElhinney; Lars Søndergaard; Aimee K Armstrong; Lisa Bergersen; Robert F Padera; David T Balzer; Te-Hsin Lung; Felix Berger; Evan M Zahn; Robert G Gray; William E Hellenbrand; Jacqueline Kreutzer; Andreas Eicken; Thomas K Jones; Peter Ewert

doi:10.1016/j.jacc.2018.09.039

Endocarditis After Transcatheter Pulmonary Valve Replacement

Doff B McElhinney, Lars Søndergaard, Aimee K Armstrong, Lisa Bergersen, Robert F Padera, David T Balzer, Te-Hsin Lung, Felix Berger, Evan M Zahn, Robert G Gray, William E Hellenbrand, Jacqueline Kreutzer, Andreas Eicken, Thomas K Jones, Peter Ewert

Institut for Klinisk Medicin

39 Citationer (Scopus)

Abstract

Background: Endocarditis has emerged as one of the most concerning adverse outcomes in patients with congenital anomalies involving the right ventricular outflow tract (RVOT) and prosthetic valves. Objectives: The aim of this study was to evaluate rates and potential risk factors for endocarditis after transcatheter pulmonary valve replacement in the prospective Melody valve trials. Methods: All patients in whom a transcatheter pulmonary valve (TPV) was implanted in the RVOT as part of 3 prospective multicenter studies comprised the analytic cohort. The diagnosis of endocarditis and involvement of the TPV were determined by the implanting investigator. Results: A total of 309 patients underwent transcatheter pulmonary valve replacement (TPVR) and were discharged with a valve in place. The median follow-up duration was 5.1 years, and total observation until study exit was 1,660.3 patient-years. Endocarditis was diagnosed in 46 patients (median 3.1 years after TPVR), and a total of 35 patients were reported to have TPV-related endocarditis (34 at the initial diagnosis, 1 with a second episode). The annualized incidence rate of endocarditis was 3.1% per patient-year and of TPV-related endocarditis was 2.4% per patient-year. At 5 years post-TPVR, freedom from a diagnosis of endocarditis was 89% and freedom from TPV-related endocarditis was 92%. By multivariable analysis, age ≤12 years at implant (hazard ratio: 2.3; 95% confidence interval: 1.2 to 4.4; p = 0.011) and immediate post-implant peak gradient ≥15 mm Hg (2.7; 95% confidence interval: 1.4 to 4.9; p = 0.002) were associated with development of endocarditis and with development of TPV-related endocarditis (age ≤12 years: 2.8; 95% confidence interval: 1.3 to 5.7; p = 0.006; gradient ≥15 mm Hg: 2.6; 95% confidence interval: 1.3 to 5.2; p = 0.008). Conclusions: Endocarditis is an important adverse outcome following TVPR in children and adults with post-operative congenital heart disease involving the RVOT. Ongoing efforts to understand, prevent, and optimize management of this complication are paramount in making the best use of TPV therapy.

Originalsprog	Engelsk
Tidsskrift	Journal of the American College of Cardiology
Vol/bind	72
Udgave nummer	22
Sider (fra-til)	2717-2728
Antal sider	12
ISSN	0735-1097
DOI	https://doi.org/10.1016/j.jacc.2018.09.039
Status	Udgivet - 4 dec. 2018

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10.1016/j.jacc.2018.09.039

Citationsformater

McElhinney, D. B., Søndergaard, L., Armstrong, A. K., Bergersen, L., Padera, R. F., Balzer, D. T., Lung, T-H., Berger, F., Zahn, E. M., Gray, R. G., Hellenbrand, W. E., Kreutzer, J., Eicken, A., Jones, T. K., & Ewert, P. (2018). Endocarditis After Transcatheter Pulmonary Valve Replacement. Journal of the American College of Cardiology, 72(22), 2717-2728. https://doi.org/10.1016/j.jacc.2018.09.039

McElhinney, DB, Søndergaard, L, Armstrong, AK, Bergersen, L, Padera, RF, Balzer, DT, Lung, T-H, Berger, F, Zahn, EM, Gray, RG, Hellenbrand, WE, Kreutzer, J, Eicken, A, Jones, TK & Ewert, P 2018, 'Endocarditis After Transcatheter Pulmonary Valve Replacement', Journal of the American College of Cardiology, bind 72, nr. 22, s. 2717-2728. https://doi.org/10.1016/j.jacc.2018.09.039

@article{c9d5126fa1b7428780a62cc0ba6ee62e,

title = "Endocarditis After Transcatheter Pulmonary Valve Replacement",

abstract = "Background: Endocarditis has emerged as one of the most concerning adverse outcomes in patients with congenital anomalies involving the right ventricular outflow tract (RVOT) and prosthetic valves. Objectives: The aim of this study was to evaluate rates and potential risk factors for endocarditis after transcatheter pulmonary valve replacement in the prospective Melody valve trials. Methods: All patients in whom a transcatheter pulmonary valve (TPV) was implanted in the RVOT as part of 3 prospective multicenter studies comprised the analytic cohort. The diagnosis of endocarditis and involvement of the TPV were determined by the implanting investigator. Results: A total of 309 patients underwent transcatheter pulmonary valve replacement (TPVR) and were discharged with a valve in place. The median follow-up duration was 5.1 years, and total observation until study exit was 1,660.3 patient-years. Endocarditis was diagnosed in 46 patients (median 3.1 years after TPVR), and a total of 35 patients were reported to have TPV-related endocarditis (34 at the initial diagnosis, 1 with a second episode). The annualized incidence rate of endocarditis was 3.1% per patient-year and of TPV-related endocarditis was 2.4% per patient-year. At 5 years post-TPVR, freedom from a diagnosis of endocarditis was 89% and freedom from TPV-related endocarditis was 92%. By multivariable analysis, age ≤12 years at implant (hazard ratio: 2.3; 95% confidence interval: 1.2 to 4.4; p = 0.011) and immediate post-implant peak gradient ≥15 mm Hg (2.7; 95% confidence interval: 1.4 to 4.9; p = 0.002) were associated with development of endocarditis and with development of TPV-related endocarditis (age ≤12 years: 2.8; 95% confidence interval: 1.3 to 5.7; p = 0.006; gradient ≥15 mm Hg: 2.6; 95% confidence interval: 1.3 to 5.2; p = 0.008). Conclusions: Endocarditis is an important adverse outcome following TVPR in children and adults with post-operative congenital heart disease involving the RVOT. Ongoing efforts to understand, prevent, and optimize management of this complication are paramount in making the best use of TPV therapy.",

author = "McElhinney, {Doff B} and Lars S{\o}ndergaard and Armstrong, {Aimee K} and Lisa Bergersen and Padera, {Robert F} and Balzer, {David T} and Te-Hsin Lung and Felix Berger and Zahn, {Evan M} and Gray, {Robert G} and Hellenbrand, {William E} and Jacqueline Kreutzer and Andreas Eicken and Jones, {Thomas K} and Peter Ewert",

year = "2018",

month = dec,

day = "4",

doi = "10.1016/j.jacc.2018.09.039",

language = "English",

volume = "72",

pages = "2717--2728",

journal = "Journal of the American College of Cardiology",

issn = "0735-1097",

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number = "22",

}

TY - JOUR

T1 - Endocarditis After Transcatheter Pulmonary Valve Replacement

AU - McElhinney, Doff B

AU - Søndergaard, Lars

AU - Armstrong, Aimee K

AU - Bergersen, Lisa

AU - Padera, Robert F

AU - Balzer, David T

AU - Lung, Te-Hsin

AU - Berger, Felix

AU - Zahn, Evan M

AU - Gray, Robert G

AU - Hellenbrand, William E

AU - Kreutzer, Jacqueline

AU - Eicken, Andreas

AU - Jones, Thomas K

AU - Ewert, Peter

PY - 2018/12/4

Y1 - 2018/12/4

N2 - Background: Endocarditis has emerged as one of the most concerning adverse outcomes in patients with congenital anomalies involving the right ventricular outflow tract (RVOT) and prosthetic valves. Objectives: The aim of this study was to evaluate rates and potential risk factors for endocarditis after transcatheter pulmonary valve replacement in the prospective Melody valve trials. Methods: All patients in whom a transcatheter pulmonary valve (TPV) was implanted in the RVOT as part of 3 prospective multicenter studies comprised the analytic cohort. The diagnosis of endocarditis and involvement of the TPV were determined by the implanting investigator. Results: A total of 309 patients underwent transcatheter pulmonary valve replacement (TPVR) and were discharged with a valve in place. The median follow-up duration was 5.1 years, and total observation until study exit was 1,660.3 patient-years. Endocarditis was diagnosed in 46 patients (median 3.1 years after TPVR), and a total of 35 patients were reported to have TPV-related endocarditis (34 at the initial diagnosis, 1 with a second episode). The annualized incidence rate of endocarditis was 3.1% per patient-year and of TPV-related endocarditis was 2.4% per patient-year. At 5 years post-TPVR, freedom from a diagnosis of endocarditis was 89% and freedom from TPV-related endocarditis was 92%. By multivariable analysis, age ≤12 years at implant (hazard ratio: 2.3; 95% confidence interval: 1.2 to 4.4; p = 0.011) and immediate post-implant peak gradient ≥15 mm Hg (2.7; 95% confidence interval: 1.4 to 4.9; p = 0.002) were associated with development of endocarditis and with development of TPV-related endocarditis (age ≤12 years: 2.8; 95% confidence interval: 1.3 to 5.7; p = 0.006; gradient ≥15 mm Hg: 2.6; 95% confidence interval: 1.3 to 5.2; p = 0.008). Conclusions: Endocarditis is an important adverse outcome following TVPR in children and adults with post-operative congenital heart disease involving the RVOT. Ongoing efforts to understand, prevent, and optimize management of this complication are paramount in making the best use of TPV therapy.

AB - Background: Endocarditis has emerged as one of the most concerning adverse outcomes in patients with congenital anomalies involving the right ventricular outflow tract (RVOT) and prosthetic valves. Objectives: The aim of this study was to evaluate rates and potential risk factors for endocarditis after transcatheter pulmonary valve replacement in the prospective Melody valve trials. Methods: All patients in whom a transcatheter pulmonary valve (TPV) was implanted in the RVOT as part of 3 prospective multicenter studies comprised the analytic cohort. The diagnosis of endocarditis and involvement of the TPV were determined by the implanting investigator. Results: A total of 309 patients underwent transcatheter pulmonary valve replacement (TPVR) and were discharged with a valve in place. The median follow-up duration was 5.1 years, and total observation until study exit was 1,660.3 patient-years. Endocarditis was diagnosed in 46 patients (median 3.1 years after TPVR), and a total of 35 patients were reported to have TPV-related endocarditis (34 at the initial diagnosis, 1 with a second episode). The annualized incidence rate of endocarditis was 3.1% per patient-year and of TPV-related endocarditis was 2.4% per patient-year. At 5 years post-TPVR, freedom from a diagnosis of endocarditis was 89% and freedom from TPV-related endocarditis was 92%. By multivariable analysis, age ≤12 years at implant (hazard ratio: 2.3; 95% confidence interval: 1.2 to 4.4; p = 0.011) and immediate post-implant peak gradient ≥15 mm Hg (2.7; 95% confidence interval: 1.4 to 4.9; p = 0.002) were associated with development of endocarditis and with development of TPV-related endocarditis (age ≤12 years: 2.8; 95% confidence interval: 1.3 to 5.7; p = 0.006; gradient ≥15 mm Hg: 2.6; 95% confidence interval: 1.3 to 5.2; p = 0.008). Conclusions: Endocarditis is an important adverse outcome following TVPR in children and adults with post-operative congenital heart disease involving the RVOT. Ongoing efforts to understand, prevent, and optimize management of this complication are paramount in making the best use of TPV therapy.

U2 - 10.1016/j.jacc.2018.09.039

DO - 10.1016/j.jacc.2018.09.039

M3 - Journal article

C2 - 30497557

SN - 0735-1097

VL - 72

SP - 2717

EP - 2728

JO - Journal of the American College of Cardiology

JF - Journal of the American College of Cardiology

IS - 22

ER -

Endocarditis After Transcatheter Pulmonary Valve Replacement

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