Covered CP stent for treatment of right ventricular conduit injury during melody transcatheter pulmonary valve replacement: Results from the PARCS study

PARCS Investigators

Research output: Contribution to journalArticle

1 Citation (Scopus)

Abstract

BACKGROUND: High-pressure balloon and stent angioplasty are frequently necessary to prepare the dysfunctional right ventricular outflow tract conduit before transcatheter pulmonary valve replacement (TPVR). Conduit injury can result, which may be catastrophic to the patient or prevent successful TPVR. METHODS AND RESULTS: The PARCS trial (Pulmonary Artery Repair With Covered Stent) was a pivotal, prospective multicenter trial to evaluate the safety and efficacy of the NuMED Covered CP Stent (CCPS) for treatment of conduit injury occurring during TPVR. The study also evaluated immediate and short-term TPVR function in patients receiving covered stents. A total of 616 patients were consented; 120 (19.5%) had a wall injury identified and were treated with CCPS. Severe conduit injuries were uncommon (5%), but predictors for severe injury were not identified. Stenotic homografts had the highest incidence of injury (29%), compared with other conduit substrates. Among patients receiving CCPS implant, 96% required no further therapy for conduit injury, and 94% underwent TPVR at that procedure. Only 2 patients (1.6%) required urgent surgery for conduit injury, despite CCPS implant. There were few CCPS-related complications. TPVR function was similar between CCPS and non-CCPS groups at follow-up. CONCLUSIONS: Conduit injury during TPVR is common, although severe injury is rare. The CCPS was a safe and effective treatment for right ventricular outflow tract conduit injury during preparation for TPVR, allowing nearly all patients to complete the procedure without identifiable impact on valve performance. CLINICAL TRIAL REGISTRATION: URL: https://www.clinicaltrials.gov. Unique identifier: NCT01824160.

Original languageEnglish (US)
Article numbere006598
JournalCirculation: Cardiovascular Interventions
Volume11
Issue number10
DOIs
StatePublished - Jan 1 2018

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Pulmonary Valve
Stents
Wounds and Injuries
Therapeutics
Balloon Angioplasty
Pulmonary Artery
Multicenter Studies
Allografts
Clinical Trials

Keywords

  • Allografts
  • Injuries
  • Methods
  • Patients
  • Pulmonary valve
  • Wounds

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine

Cite this

@article{43705514721c4216a5ffc9c1d15c8c3f,
title = "Covered CP stent for treatment of right ventricular conduit injury during melody transcatheter pulmonary valve replacement: Results from the PARCS study",
abstract = "BACKGROUND: High-pressure balloon and stent angioplasty are frequently necessary to prepare the dysfunctional right ventricular outflow tract conduit before transcatheter pulmonary valve replacement (TPVR). Conduit injury can result, which may be catastrophic to the patient or prevent successful TPVR. METHODS AND RESULTS: The PARCS trial (Pulmonary Artery Repair With Covered Stent) was a pivotal, prospective multicenter trial to evaluate the safety and efficacy of the NuMED Covered CP Stent (CCPS) for treatment of conduit injury occurring during TPVR. The study also evaluated immediate and short-term TPVR function in patients receiving covered stents. A total of 616 patients were consented; 120 (19.5{\%}) had a wall injury identified and were treated with CCPS. Severe conduit injuries were uncommon (5{\%}), but predictors for severe injury were not identified. Stenotic homografts had the highest incidence of injury (29{\%}), compared with other conduit substrates. Among patients receiving CCPS implant, 96{\%} required no further therapy for conduit injury, and 94{\%} underwent TPVR at that procedure. Only 2 patients (1.6{\%}) required urgent surgery for conduit injury, despite CCPS implant. There were few CCPS-related complications. TPVR function was similar between CCPS and non-CCPS groups at follow-up. CONCLUSIONS: Conduit injury during TPVR is common, although severe injury is rare. The CCPS was a safe and effective treatment for right ventricular outflow tract conduit injury during preparation for TPVR, allowing nearly all patients to complete the procedure without identifiable impact on valve performance. CLINICAL TRIAL REGISTRATION: URL: https://www.clinicaltrials.gov. Unique identifier: NCT01824160.",
keywords = "Allografts, Injuries, Methods, Patients, Pulmonary valve, Wounds",
author = "{PARCS Investigators} and Delaney, {Jeffrey W} and Goldstein, {Bryan H.} and Bishnoi, {Ram N.} and Bisselou, {Karl S.M.} and Kerry McEnaney and Matthew Minahan and Ringel, {Richard E.}",
year = "2018",
month = "1",
day = "1",
doi = "10.1161/CIRCINTERVENTIONS.118.006598",
language = "English (US)",
volume = "11",
journal = "Circulation: Cardiovascular Interventions",
issn = "1941-7640",
publisher = "Lippincott Williams and Wilkins",
number = "10",

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TY - JOUR

T1 - Covered CP stent for treatment of right ventricular conduit injury during melody transcatheter pulmonary valve replacement

T2 - Results from the PARCS study

AU - PARCS Investigators

AU - Delaney, Jeffrey W

AU - Goldstein, Bryan H.

AU - Bishnoi, Ram N.

AU - Bisselou, Karl S.M.

AU - McEnaney, Kerry

AU - Minahan, Matthew

AU - Ringel, Richard E.

PY - 2018/1/1

Y1 - 2018/1/1

N2 - BACKGROUND: High-pressure balloon and stent angioplasty are frequently necessary to prepare the dysfunctional right ventricular outflow tract conduit before transcatheter pulmonary valve replacement (TPVR). Conduit injury can result, which may be catastrophic to the patient or prevent successful TPVR. METHODS AND RESULTS: The PARCS trial (Pulmonary Artery Repair With Covered Stent) was a pivotal, prospective multicenter trial to evaluate the safety and efficacy of the NuMED Covered CP Stent (CCPS) for treatment of conduit injury occurring during TPVR. The study also evaluated immediate and short-term TPVR function in patients receiving covered stents. A total of 616 patients were consented; 120 (19.5%) had a wall injury identified and were treated with CCPS. Severe conduit injuries were uncommon (5%), but predictors for severe injury were not identified. Stenotic homografts had the highest incidence of injury (29%), compared with other conduit substrates. Among patients receiving CCPS implant, 96% required no further therapy for conduit injury, and 94% underwent TPVR at that procedure. Only 2 patients (1.6%) required urgent surgery for conduit injury, despite CCPS implant. There were few CCPS-related complications. TPVR function was similar between CCPS and non-CCPS groups at follow-up. CONCLUSIONS: Conduit injury during TPVR is common, although severe injury is rare. The CCPS was a safe and effective treatment for right ventricular outflow tract conduit injury during preparation for TPVR, allowing nearly all patients to complete the procedure without identifiable impact on valve performance. CLINICAL TRIAL REGISTRATION: URL: https://www.clinicaltrials.gov. Unique identifier: NCT01824160.

AB - BACKGROUND: High-pressure balloon and stent angioplasty are frequently necessary to prepare the dysfunctional right ventricular outflow tract conduit before transcatheter pulmonary valve replacement (TPVR). Conduit injury can result, which may be catastrophic to the patient or prevent successful TPVR. METHODS AND RESULTS: The PARCS trial (Pulmonary Artery Repair With Covered Stent) was a pivotal, prospective multicenter trial to evaluate the safety and efficacy of the NuMED Covered CP Stent (CCPS) for treatment of conduit injury occurring during TPVR. The study also evaluated immediate and short-term TPVR function in patients receiving covered stents. A total of 616 patients were consented; 120 (19.5%) had a wall injury identified and were treated with CCPS. Severe conduit injuries were uncommon (5%), but predictors for severe injury were not identified. Stenotic homografts had the highest incidence of injury (29%), compared with other conduit substrates. Among patients receiving CCPS implant, 96% required no further therapy for conduit injury, and 94% underwent TPVR at that procedure. Only 2 patients (1.6%) required urgent surgery for conduit injury, despite CCPS implant. There were few CCPS-related complications. TPVR function was similar between CCPS and non-CCPS groups at follow-up. CONCLUSIONS: Conduit injury during TPVR is common, although severe injury is rare. The CCPS was a safe and effective treatment for right ventricular outflow tract conduit injury during preparation for TPVR, allowing nearly all patients to complete the procedure without identifiable impact on valve performance. CLINICAL TRIAL REGISTRATION: URL: https://www.clinicaltrials.gov. Unique identifier: NCT01824160.

KW - Allografts

KW - Injuries

KW - Methods

KW - Patients

KW - Pulmonary valve

KW - Wounds

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