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Covered CP Stent for Treatment of Right Ventricular Conduit Injury During Melody Transcatheter Pulmonary Valve Replacement.
Circ Cardiovasc Interv. 2018 10; 11(10):e006598.CC

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.

Authors+Show Affiliations

Division of Pediatric Cardiology, Department of Pediatrics, University of Nebraska Medical Center, Children's Hospital and Medical Center, Omaha (J.W.D., K.S.M.B.).Division of Cardiology, The Heart Institute, Cincinnati Children's Hospital Medical Center, OH (B.H.G.).Division of Cardiology, Department of Pediatrics, Janet Weis Children's Hospital, Geisinger Medical Center, Temple University School of Medicine, Danville, PA (R.N.B.).Division of Pediatric Cardiology, Department of Pediatrics, University of Nebraska Medical Center, Children's Hospital and Medical Center, Omaha (J.W.D., K.S.M.B.).Department of Cardiology, Boston Children's Hospital, Harvard School of Medicine, MA (K.M., M.M.).Department of Cardiology, Boston Children's Hospital, Harvard School of Medicine, MA (K.M., M.M.).Division of Pediatric Cardiology, Department of Pediatrics, Johns Hopkins University School of Medicine, Baltimore, MD (R.E.R.).No affiliation info available

Pub Type(s)

Clinical Trial
Journal Article
Multicenter Study
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

30354627

Citation

Delaney, Jeffrey W., et al. "Covered CP Stent for Treatment of Right Ventricular Conduit Injury During Melody Transcatheter Pulmonary Valve Replacement." Circulation. Cardiovascular Interventions, vol. 11, no. 10, 2018, pp. e006598.
Delaney JW, Goldstein BH, Bishnoi RN, et al. Covered CP Stent for Treatment of Right Ventricular Conduit Injury During Melody Transcatheter Pulmonary Valve Replacement. Circ Cardiovasc Interv. 2018;11(10):e006598.
Delaney, J. W., Goldstein, B. H., Bishnoi, R. N., Bisselou, K. S. M., McEnaney, K., Minahan, M., & Ringel, R. E. (2018). Covered CP Stent for Treatment of Right Ventricular Conduit Injury During Melody Transcatheter Pulmonary Valve Replacement. Circulation. Cardiovascular Interventions, 11(10), e006598. https://doi.org/10.1161/CIRCINTERVENTIONS.118.006598
Delaney JW, et al. Covered CP Stent for Treatment of Right Ventricular Conduit Injury During Melody Transcatheter Pulmonary Valve Replacement. Circ Cardiovasc Interv. 2018;11(10):e006598. PubMed PMID: 30354627.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Covered CP Stent for Treatment of Right Ventricular Conduit Injury During Melody Transcatheter Pulmonary Valve Replacement. 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, AU - ,, PY - 2018/10/26/entrez PY - 2018/10/26/pubmed PY - 2019/10/30/medline KW - allografts KW - methods KW - patients KW - pulmonary valve KW - wounds and injuries SP - e006598 EP - e006598 JF - Circulation. Cardiovascular interventions JO - Circ Cardiovasc Interv VL - 11 IS - 10 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. SN - 1941-7632 UR - https://www.unboundmedicine.com/medline/citation/30354627/Covered_CP_Stent_for_Treatment_of_Right_Ventricular_Conduit_Injury_During_Melody_Transcatheter_Pulmonary_Valve_Replacement_ L2 - https://www.ahajournals.org/doi/10.1161/CIRCINTERVENTIONS.118.006598?url_ver=Z39.88-2003&rfr_id=ori:rid:crossref.org&rfr_dat=cr_pub=pubmed DB - PRIME DP - Unbound Medicine ER -