Reintervention and Survival After Transcatheter Pulmonary Valve Replacement

Doff B. McElhinney; Yulin Zhang; Daniel S. Levi; Stanimir Georgiev; Elzbieta 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 Ruzyllo; 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
, Elzbieta 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 Ruzyllo
, Felix Berger
, Lars Sondergaard
, Dietmar Schranz

John P. Cheatham, Thomas K. Jones, Peter Ewert, Stephan Schubert

^*Corresponding author for this work

Research output: Contribution to journal › Journal article › Research › peer-review

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. (C) 2022 by the American College of Cardiology Foundation.

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 - 2022

Funding

Dr McElhinney has served as a consultant for Medtronic. Dr Levi has served as a consultant for Edwards and Medtronic. Dr Goldstein has served as a consultant for Medtronic. Dr Shahanavaz has served as a consultant for Edwards and Medtronic. Dr Qureshi has served as a consultant for Edwards, Medtronic, W.L. Gore and Associates, and Abiomed Inc. Dr Cabalka has served as a consultant for Medtronic. Dr Torres has served as a proctor for Edwards. Dr Morray has served as a consultant for Medtronic. Dr Armstrong has served as a consultant for Edwards and Medtronic; and has received research grants from Edwards. Dr Aboulhosn has served as a consultant for Edwards and Medtronic; and has received research grants from Edwards. Dr Berger has served as a consultant for Medtronic. Dr Sondergaard has served as a consultant for and received research grants from Edwards and Medtronic. Dr Schranz has served as a consultant for Medtronic. Dr Jones has served as a consultant for and received research grants from Edwards and Medtronic. Dr Cheatham has served as a consultant for Medtronic and NuMED. Dr Schubert has served as a proctor for Abbott, Edwards, Gore, Lifetech, and Medtronic. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.

Keywords

pediatric
pulmonary atresia
pulmonary valve
Ross procedure
tetralogy of Fallot
FOLLOW-UP
BIOPROSTHETIC VALVES
OUTCOMES
IMPLANTATION
ADULTS
DURABILITY
TETRALOGY
VENTRICLE
HOMOGRAFT
OPERATION

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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., Ruzyllo, 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, Ruzyllo, 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

@article{c91fbd4e88bf4f0f852ebfda64e4cda5,

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. (C) 2022 by the American College of Cardiology Foundation.",

keywords = "pediatric, pulmonary atresia, pulmonary valve, Ross procedure, tetralogy of Fallot, FOLLOW-UP, BIOPROSTHETIC VALVES, OUTCOMES, IMPLANTATION, ADULTS, DURABILITY, TETRALOGY, VENTRICLE, HOMOGRAFT, OPERATION",

author = "McElhinney, \{Doff B.\} and Yulin Zhang and Levi, \{Daniel S.\} and Stanimir Georgiev and Biernacka, \{Elzbieta 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 Ruzyllo 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",

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",

number = "1",

}

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, Elzbieta 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 - Ruzyllo, 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

Y1 - 2022

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. (C) 2022 by the American College of Cardiology Foundation.

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. (C) 2022 by the American College of Cardiology Foundation.

KW - pediatric

KW - pulmonary atresia

KW - pulmonary valve

KW - Ross procedure

KW - tetralogy of Fallot

KW - FOLLOW-UP

KW - BIOPROSTHETIC VALVES

KW - OUTCOMES

KW - IMPLANTATION

KW - ADULTS

KW - DURABILITY

KW - TETRALOGY

KW - VENTRICLE

KW - HOMOGRAFT

KW - OPERATION

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 -