Reintervention and Survival After Transcatheter Pulmonary Valve Replacement

Doff B McElhinney; Yulin Zhang; Daniel S Levi; Stanimir Georgiev; Elżbieta Katarzyna Biernacka; Bryan H Goldstein; Shabana Shahanavaz; Athar M Qureshi; Allison K Cabalka; Holly Bauser-Heaton; Alejandro J Torres; Brian H Morray; Aimee K Armstrong; Oscar Millan-Iturbe; Lynn F Peng; Jamil A Aboulhosn; Witold Rużyłło; Felix Berger; Lars Sondergaard; Dietmar Schranz; John P Cheatham; Thomas K Jones; Peter Ewert; Stephan Schubert

doi:10.1016/j.jacc.2021.10.031

Reintervention and Survival After Transcatheter Pulmonary Valve Replacement

Doff B McElhinney, Yulin Zhang, Daniel S Levi, Stanimir Georgiev, Elżbieta Katarzyna Biernacka, Bryan H Goldstein, Shabana Shahanavaz, Athar M Qureshi, Allison K Cabalka, Holly Bauser-Heaton, Alejandro J Torres, Brian H Morray, Aimee K Armstrong, Oscar Millan-Iturbe, Lynn F Peng, Jamil A Aboulhosn, Witold Rużyłło, Felix Berger, Lars Sondergaard, Dietmar SchranzJohn P Cheatham, Thomas K Jones, Peter Ewert, Stephan Schubert

Department of Cardiology

48 Citations (Scopus)

Abstract

BACKGROUND: Transcatheter pulmonary valve (TPV) replacement (TPVR) has become the standard therapy for postoperative pulmonary outflow tract dysfunction in patients with a prosthetic conduit/valve, but there is limited information about risk factors for death or reintervention after this procedure.

OBJECTIVES: This study sought to evaluate mid- and long-term outcomes after TPVR in a large multicenter cohort.

METHODS: International registry focused on time-related outcomes after TPVR.

RESULTS: Investigators submitted data for 2,476 patients who underwent TPVR and were followed up for 8,475 patient-years. A total of 95 patients died after TPVR, most commonly from heart failure (n = 24). The cumulative incidence of death was 8.9% (95% CI: 6.9%-11.5%) 8 years after TPVR. On multivariable analysis, age at TPVR (HR: 1.04 per year; 95% CI: 1.03-1.06 per year; P < 0.001), a prosthetic valve in other positions (HR: 2.1; 95% CI: 1.2-3.7; P = 0.014), and an existing transvenous pacemaker/implantable cardioverter-defibrillator (HR: 2.1; 95% CI: 1.3-3.4; P = 0.004) were associated with death. A total of 258 patients underwent TPV reintervention. At 8 years, the cumulative incidence of any TPV reintervention was 25.1% (95% CI: 21.8%-28.5%) and of surgical TPV reintervention was 14.4% (95% CI: 11.9%-17.2%). Risk factors for surgical reintervention included age (0.95 per year [95% CI: 0.93-0.97 per year]; P < 0.001), prior endocarditis (2.5 [95% CI: 1.4-4.3]; P = 0.001), TPVR into a stented bioprosthetic valve (1.7 [95% CI: 1.2-2.5]; P = 0.007), and postimplant gradient (1.4 per 10 mm Hg [95% CI: 1.2-1.7 per 10 mm Hg]: P < 0.001).

CONCLUSIONS: These findings support the conclusion that survival and freedom from reintervention or surgery after TPVR are generally comparable to outcomes of surgical conduit/valve replacement across a wide age range.

Original language	English
Journal	Journal of the American College of Cardiology
Volume	79
Issue number	1
Pages (from-to)	18-32
Number of pages	15
ISSN	0735-1097
DOIs	https://doi.org/10.1016/j.jacc.2021.10.031
Publication status	Published - 4 Jan 2022

Keywords

Adolescent
Adult
Age Factors
Child
Child, Preschool
Defibrillators, Implantable
Endocarditis/epidemiology
Female
Heart Valve Prosthesis
Heart Valve Prosthesis Implantation/mortality
Humans
Infant
Infant, Newborn
Male
Middle Aged
Pacemaker, Artificial
Pulmonary Valve/surgery
Registries
Reoperation/statistics & numerical data
Young Adult

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10.1016/j.jacc.2021.10.031

Cite this

McElhinney, D. B., Zhang, Y., Levi, D. S., Georgiev, S., Biernacka, E. K., Goldstein, B. H., Shahanavaz, S., Qureshi, A. M., Cabalka, A. K., Bauser-Heaton, H., Torres, A. J., Morray, B. H., Armstrong, A. K., Millan-Iturbe, O., Peng, L. F., Aboulhosn, J. A., Rużyłło, W., Berger, F., Sondergaard, L., ... Schubert, S. (2022). Reintervention and Survival After Transcatheter Pulmonary Valve Replacement. Journal of the American College of Cardiology, 79(1), 18-32. https://doi.org/10.1016/j.jacc.2021.10.031

McElhinney, DB, Zhang, Y, Levi, DS, Georgiev, S, Biernacka, EK, Goldstein, BH, Shahanavaz, S, Qureshi, AM, Cabalka, AK, Bauser-Heaton, H, Torres, AJ, Morray, BH, Armstrong, AK, Millan-Iturbe, O, Peng, LF, Aboulhosn, JA, Rużyłło, W, Berger, F, Sondergaard, L, Schranz, D, Cheatham, JP, Jones, TK, Ewert, P & Schubert, S 2022, 'Reintervention and Survival After Transcatheter Pulmonary Valve Replacement', Journal of the American College of Cardiology, vol. 79, no. 1, pp. 18-32. https://doi.org/10.1016/j.jacc.2021.10.031

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title = "Reintervention and Survival After Transcatheter Pulmonary Valve Replacement",

abstract = "BACKGROUND: Transcatheter pulmonary valve (TPV) replacement (TPVR) has become the standard therapy for postoperative pulmonary outflow tract dysfunction in patients with a prosthetic conduit/valve, but there is limited information about risk factors for death or reintervention after this procedure.OBJECTIVES: This study sought to evaluate mid- and long-term outcomes after TPVR in a large multicenter cohort.METHODS: International registry focused on time-related outcomes after TPVR.RESULTS: Investigators submitted data for 2,476 patients who underwent TPVR and were followed up for 8,475 patient-years. A total of 95 patients died after TPVR, most commonly from heart failure (n = 24). The cumulative incidence of death was 8.9% (95% CI: 6.9%-11.5%) 8 years after TPVR. On multivariable analysis, age at TPVR (HR: 1.04 per year; 95% CI: 1.03-1.06 per year; P < 0.001), a prosthetic valve in other positions (HR: 2.1; 95% CI: 1.2-3.7; P = 0.014), and an existing transvenous pacemaker/implantable cardioverter-defibrillator (HR: 2.1; 95% CI: 1.3-3.4; P = 0.004) were associated with death. A total of 258 patients underwent TPV reintervention. At 8 years, the cumulative incidence of any TPV reintervention was 25.1% (95% CI: 21.8%-28.5%) and of surgical TPV reintervention was 14.4% (95% CI: 11.9%-17.2%). Risk factors for surgical reintervention included age (0.95 per year [95% CI: 0.93-0.97 per year]; P < 0.001), prior endocarditis (2.5 [95% CI: 1.4-4.3]; P = 0.001), TPVR into a stented bioprosthetic valve (1.7 [95% CI: 1.2-2.5]; P = 0.007), and postimplant gradient (1.4 per 10 mm Hg [95% CI: 1.2-1.7 per 10 mm Hg]: P < 0.001).CONCLUSIONS: These findings support the conclusion that survival and freedom from reintervention or surgery after TPVR are generally comparable to outcomes of surgical conduit/valve replacement across a wide age range.",

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author = "McElhinney, {Doff B} and Yulin Zhang and Levi, {Daniel S} and Stanimir Georgiev and Biernacka, {El{\.z}bieta Katarzyna} and Goldstein, {Bryan H} and Shabana Shahanavaz and Qureshi, {Athar M} and Cabalka, {Allison K} and Holly Bauser-Heaton and Torres, {Alejandro J} and Morray, {Brian H} and Armstrong, {Aimee K} and Oscar Millan-Iturbe and Peng, {Lynn F} and Aboulhosn, {Jamil A} and Witold Ru{\.z}y{\l}{\l}o and Felix Berger and Lars Sondergaard and Dietmar Schranz and Cheatham, {John P} and Jones, {Thomas K} and Peter Ewert and Stephan Schubert",

year = "2022",

month = jan,

day = "4",

doi = "10.1016/j.jacc.2021.10.031",

language = "English",

volume = "79",

pages = "18--32",

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

issn = "0735-1097",

publisher = "Elsevier Inc",

number = "1",

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TY - JOUR

T1 - Reintervention and Survival After Transcatheter Pulmonary Valve Replacement

AU - McElhinney, Doff B

AU - Zhang, Yulin

AU - Levi, Daniel S

AU - Georgiev, Stanimir

AU - Biernacka, Elżbieta Katarzyna

AU - Goldstein, Bryan H

AU - Shahanavaz, Shabana

AU - Qureshi, Athar M

AU - Cabalka, Allison K

AU - Bauser-Heaton, Holly

AU - Torres, Alejandro J

AU - Morray, Brian H

AU - Armstrong, Aimee K

AU - Millan-Iturbe, Oscar

AU - Peng, Lynn F

AU - Aboulhosn, Jamil A

AU - Rużyłło, Witold

AU - Berger, Felix

AU - Sondergaard, Lars

AU - Schranz, Dietmar

AU - Cheatham, John P

AU - Jones, Thomas K

AU - Ewert, Peter

AU - Schubert, Stephan

PY - 2022/1/4

Y1 - 2022/1/4

N2 - BACKGROUND: Transcatheter pulmonary valve (TPV) replacement (TPVR) has become the standard therapy for postoperative pulmonary outflow tract dysfunction in patients with a prosthetic conduit/valve, but there is limited information about risk factors for death or reintervention after this procedure.OBJECTIVES: This study sought to evaluate mid- and long-term outcomes after TPVR in a large multicenter cohort.METHODS: International registry focused on time-related outcomes after TPVR.RESULTS: Investigators submitted data for 2,476 patients who underwent TPVR and were followed up for 8,475 patient-years. A total of 95 patients died after TPVR, most commonly from heart failure (n = 24). The cumulative incidence of death was 8.9% (95% CI: 6.9%-11.5%) 8 years after TPVR. On multivariable analysis, age at TPVR (HR: 1.04 per year; 95% CI: 1.03-1.06 per year; P < 0.001), a prosthetic valve in other positions (HR: 2.1; 95% CI: 1.2-3.7; P = 0.014), and an existing transvenous pacemaker/implantable cardioverter-defibrillator (HR: 2.1; 95% CI: 1.3-3.4; P = 0.004) were associated with death. A total of 258 patients underwent TPV reintervention. At 8 years, the cumulative incidence of any TPV reintervention was 25.1% (95% CI: 21.8%-28.5%) and of surgical TPV reintervention was 14.4% (95% CI: 11.9%-17.2%). Risk factors for surgical reintervention included age (0.95 per year [95% CI: 0.93-0.97 per year]; P < 0.001), prior endocarditis (2.5 [95% CI: 1.4-4.3]; P = 0.001), TPVR into a stented bioprosthetic valve (1.7 [95% CI: 1.2-2.5]; P = 0.007), and postimplant gradient (1.4 per 10 mm Hg [95% CI: 1.2-1.7 per 10 mm Hg]: P < 0.001).CONCLUSIONS: These findings support the conclusion that survival and freedom from reintervention or surgery after TPVR are generally comparable to outcomes of surgical conduit/valve replacement across a wide age range.

AB - BACKGROUND: Transcatheter pulmonary valve (TPV) replacement (TPVR) has become the standard therapy for postoperative pulmonary outflow tract dysfunction in patients with a prosthetic conduit/valve, but there is limited information about risk factors for death or reintervention after this procedure.OBJECTIVES: This study sought to evaluate mid- and long-term outcomes after TPVR in a large multicenter cohort.METHODS: International registry focused on time-related outcomes after TPVR.RESULTS: Investigators submitted data for 2,476 patients who underwent TPVR and were followed up for 8,475 patient-years. A total of 95 patients died after TPVR, most commonly from heart failure (n = 24). The cumulative incidence of death was 8.9% (95% CI: 6.9%-11.5%) 8 years after TPVR. On multivariable analysis, age at TPVR (HR: 1.04 per year; 95% CI: 1.03-1.06 per year; P < 0.001), a prosthetic valve in other positions (HR: 2.1; 95% CI: 1.2-3.7; P = 0.014), and an existing transvenous pacemaker/implantable cardioverter-defibrillator (HR: 2.1; 95% CI: 1.3-3.4; P = 0.004) were associated with death. A total of 258 patients underwent TPV reintervention. At 8 years, the cumulative incidence of any TPV reintervention was 25.1% (95% CI: 21.8%-28.5%) and of surgical TPV reintervention was 14.4% (95% CI: 11.9%-17.2%). Risk factors for surgical reintervention included age (0.95 per year [95% CI: 0.93-0.97 per year]; P < 0.001), prior endocarditis (2.5 [95% CI: 1.4-4.3]; P = 0.001), TPVR into a stented bioprosthetic valve (1.7 [95% CI: 1.2-2.5]; P = 0.007), and postimplant gradient (1.4 per 10 mm Hg [95% CI: 1.2-1.7 per 10 mm Hg]: P < 0.001).CONCLUSIONS: These findings support the conclusion that survival and freedom from reintervention or surgery after TPVR are generally comparable to outcomes of surgical conduit/valve replacement across a wide age range.

KW - Adolescent

KW - Adult

KW - Age Factors

KW - Child

KW - Child, Preschool

KW - Defibrillators, Implantable

KW - Endocarditis/epidemiology

KW - Female

KW - Heart Valve Prosthesis

KW - Heart Valve Prosthesis Implantation/mortality

KW - Humans

KW - Infant

KW - Infant, Newborn

KW - Male

KW - Middle Aged

KW - Pacemaker, Artificial

KW - Pulmonary Valve/surgery

KW - Registries

KW - Reoperation/statistics & numerical data

KW - Young Adult

UR - http://www.scopus.com/inward/record.url?scp=85121575084&partnerID=8YFLogxK

U2 - 10.1016/j.jacc.2021.10.031

DO - 10.1016/j.jacc.2021.10.031

M3 - Journal article

C2 - 34991785

SN - 0735-1097

VL - 79

SP - 18

EP - 32

JO - Journal of the American College of Cardiology

JF - Journal of the American College of Cardiology

IS - 1

ER -

Reintervention and Survival After Transcatheter Pulmonary Valve Replacement

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