Tags

Type your tag names separated by a space and hit enter

Outcomes After Transcatheter Reintervention for Dysfunction of a Previously Implanted Transcatheter Pulmonary Valve.
JACC Cardiovasc Interv. 2020 07 13; 13(13):1529-1540.JC

Abstract

OBJECTIVES

The aim of this analysis was to evaluate outcomes following transcatheter reintervention for degenerated transcatheter pulmonary valves (TPVs).

BACKGROUND

TPV replacement (TPVR) with the Melody valve demonstrated sustained relief of right ventricular outflow tract (RVOT) obstruction and pulmonary regurgitation.

METHODS

All patients who underwent TPVR with a Melody valve as part of 3 Medtronic-sponsored prospective multicenter studies were included. Transcatheter reinterventions included balloon dilation of the previously implanted Melody valve, placement of a bare-metal stent within the implanted TPV, or placement of a new TPV in the RVOT (TPV-in-TPV). Indications for reintervention, decisions to reintervene, and the method of reintervention were at physician discretion. All patients provided written informed consent to participate in the trials, and each trial was approved by local or central Institutional Review Boards or ethics committees at participating sites.

RESULTS

A total of 309 patients who underwent TPVR were discharged from the implantation hospitalization with Melody valves in place. Transcatheter reintervention on the TPV was performed in 46 patients. The first transcatheter reintervention consisted of TPV-in-TPV in 28 patients (median 6.9 years [quartile 1 to quartile 3: 5.2 to 7.8 years] after TPVR), simple balloon dilation of the implanted Melody valve in 17 (median 4.9 years [quartile 1 to quartile 3: 4.0 to 6.0 years] after TPVR), and bare-metal stent placement alone in 1 (4.4 years after TPVR). There were no major procedural complications. Overall, 4-year freedom from explant and from any later RVOT reintervention after the first reintervention were 83% and 60%, respectively. Freedom from repeat RVOT reintervention was longer in patients undergoing TPV-in-TPV than balloon dilation (71% vs. 46% at 4 years; p = 0.027).

CONCLUSIONS

TPV-in-TPV can be an effective and durable treatment for Melody valve dysfunction. Although balloon dilation of the Melody valve was also acutely effective at reducing RVOT obstruction, the durability of this therapy was limited in this cohort compared with TPV-in-TPV.

Authors+Show Affiliations

St. Louis Children's Hospital, St. Louis, Missouri. Electronic address: shahanavaz_s@wustl.edu.German Heart Institute Berlin, Berlin, Germany.Seattle Children's Hospital, Seattle, Washington.UPMC Children's Hospital of Pittsburgh, Pittsburgh, Pennsylvania.Columbia University Medical Center, New York, New York.German Heart Center Munich, Munich, Germany.Boston Children's Hospital, Boston, Massachusetts.Children's Hospital of Philadelphia, Philadelphia, Pennsylvania.Cedars-Sinai Heart Institute, Los Angeles, California.The Heart Center, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.The Heart Center, Nationwide Children's Hospital, Columbus, Ohio.Coronary and Structural Heart Biostatistics Department, Medtronic, Mounds View, Minnesota.St. Louis Children's Hospital, St. Louis, Missouri.Lucile Packard Children's Hospital Stanford, Palo Alto, California.

Pub Type(s)

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

Language

eng

PubMed ID

32646693

Citation

Shahanavaz, Shabana, et al. "Outcomes After Transcatheter Reintervention for Dysfunction of a Previously Implanted Transcatheter Pulmonary Valve." JACC. Cardiovascular Interventions, vol. 13, no. 13, 2020, pp. 1529-1540.
Shahanavaz S, Berger F, Jones TK, et al. Outcomes After Transcatheter Reintervention for Dysfunction of a Previously Implanted Transcatheter Pulmonary Valve. JACC Cardiovasc Interv. 2020;13(13):1529-1540.
Shahanavaz, S., Berger, F., Jones, T. K., Kreutzer, J., Vincent, J. A., Eicken, A., Bergersen, L., Rome, J. J., Zahn, E., Søndergaard, L., Cheatham, J. P., Weng, S., Balzer, D., & McElhinney, D. (2020). Outcomes After Transcatheter Reintervention for Dysfunction of a Previously Implanted Transcatheter Pulmonary Valve. JACC. Cardiovascular Interventions, 13(13), 1529-1540. https://doi.org/10.1016/j.jcin.2020.03.035
Shahanavaz S, et al. Outcomes After Transcatheter Reintervention for Dysfunction of a Previously Implanted Transcatheter Pulmonary Valve. JACC Cardiovasc Interv. 2020 07 13;13(13):1529-1540. PubMed PMID: 32646693.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Outcomes After Transcatheter Reintervention for Dysfunction of a Previously Implanted Transcatheter Pulmonary Valve. AU - Shahanavaz,Shabana, AU - Berger,Felix, AU - Jones,Thomas K, AU - Kreutzer,Jacqueline, AU - Vincent,Julie A, AU - Eicken,Andreas, AU - Bergersen,Lisa, AU - Rome,Jonathan J, AU - Zahn,Evan, AU - Søndergaard,Lars, AU - Cheatham,John P, AU - Weng,Shicheng, AU - Balzer,David, AU - McElhinney,Doff, PY - 2019/08/02/received PY - 2020/03/04/revised PY - 2020/03/24/accepted PY - 2020/7/11/entrez PY - 2020/7/11/pubmed PY - 2020/7/11/medline KW - Melody valve KW - balloon dilation KW - pulmonary valve replacement KW - pulmonary valvuloplasty SP - 1529 EP - 1540 JF - JACC. Cardiovascular interventions JO - JACC Cardiovasc Interv VL - 13 IS - 13 N2 - OBJECTIVES: The aim of this analysis was to evaluate outcomes following transcatheter reintervention for degenerated transcatheter pulmonary valves (TPVs). BACKGROUND: TPV replacement (TPVR) with the Melody valve demonstrated sustained relief of right ventricular outflow tract (RVOT) obstruction and pulmonary regurgitation. METHODS: All patients who underwent TPVR with a Melody valve as part of 3 Medtronic-sponsored prospective multicenter studies were included. Transcatheter reinterventions included balloon dilation of the previously implanted Melody valve, placement of a bare-metal stent within the implanted TPV, or placement of a new TPV in the RVOT (TPV-in-TPV). Indications for reintervention, decisions to reintervene, and the method of reintervention were at physician discretion. All patients provided written informed consent to participate in the trials, and each trial was approved by local or central Institutional Review Boards or ethics committees at participating sites. RESULTS: A total of 309 patients who underwent TPVR were discharged from the implantation hospitalization with Melody valves in place. Transcatheter reintervention on the TPV was performed in 46 patients. The first transcatheter reintervention consisted of TPV-in-TPV in 28 patients (median 6.9 years [quartile 1 to quartile 3: 5.2 to 7.8 years] after TPVR), simple balloon dilation of the implanted Melody valve in 17 (median 4.9 years [quartile 1 to quartile 3: 4.0 to 6.0 years] after TPVR), and bare-metal stent placement alone in 1 (4.4 years after TPVR). There were no major procedural complications. Overall, 4-year freedom from explant and from any later RVOT reintervention after the first reintervention were 83% and 60%, respectively. Freedom from repeat RVOT reintervention was longer in patients undergoing TPV-in-TPV than balloon dilation (71% vs. 46% at 4 years; p = 0.027). CONCLUSIONS: TPV-in-TPV can be an effective and durable treatment for Melody valve dysfunction. Although balloon dilation of the Melody valve was also acutely effective at reducing RVOT obstruction, the durability of this therapy was limited in this cohort compared with TPV-in-TPV. SN - 1876-7605 UR - https://www.unboundmedicine.com/medline/citation/32646693/Outcomes_After_Transcatheter_Reintervention_for_Dysfunction_of_a_Previously_Implanted_Transcatheter_Pulmonary_Valve_ DB - PRIME DP - Unbound Medicine ER -