Original Investigation
Reintervention and Survival After Transcatheter Pulmonary Valve Replacement

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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.

Key Words

pediatric
pulmonary atresia
pulmonary valve
Ross procedure
tetralogy of Fallot

Abbreviations and Acronyms

PR
pulmonary regurgitation
RVOT
right ventricular outflow tract
TPV
transcatheter pulmonary valve
TPVR
transcatheter pulmonary valve replacement

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The authors attest they are in compliance with human studies committees and animal welfare regulations of the authors’ institutions and Food and Drug Administration guidelines, including patient consent where appropriate. For more information, visit the Author Center.

Dr Millan-Iturbe is currently affiliated with Centro Medico Nacional Siglo XXI, Mexico City, Mexico.

Dr Schubert is currently affiliated with Ruhr University of Bochum, Bad Oeynhausen, Germany.

Drs Schubert and Ewert contributed equally to this work.