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3-Year Outcomes of the Edwards SAPIEN Transcatheter Heart Valve for Conduit Failure in the Pulmonary Position From the COMPASSION Multicenter Clinical Trial.

Publication ,  Journal Article
Kenny, D; Rhodes, JF; Fleming, GA; Kar, S; Zahn, EM; Vincent, J; Shirali, GS; Gorelick, J; Fogel, MA; Fahey, JT; Kim, DW; Babaliaros, VC ...
Published in: JACC Cardiovasc Interv
October 8, 2018

OBJECTIVES: This study provides the 3-year follow-up results of the COMPASSION (Congenital Multicenter Trial of Pulmonic Valve Regurgitation Studying the SAPIEN Transcatheter Heart Valve) trial. Patients with moderate to severe pulmonary regurgitation and/or right ventricular outflow tract conduit obstruction were implanted with the SAPIEN transcatheter heart valve (THV). BACKGROUND: Early safety and efficacy of the Edwards SAPIEN THV in the pulmonary position have been established through a multicenter clinical trial. METHODS: Eligible patients were included if body weight was >35 kg and in situ conduit diameter was ≥16 and ≤24 mm. Adverse events were adjudicated by an independent clinical events committee. Three-year clinical and echocardiographic outcomes were evaluated in these patients. RESULTS: Fifty-seven of the 63 eligible patients were accounted for at the 3-year follow-up visit from a total of 69 implantations in 81 enrolled patients. THV implantation was indicated for pulmonary stenosis (7.6%), regurgitation (12.7%), or both (79.7%). Twenty-two patients (27.8%) underwent implantation of 26-mm valves, and 47 patients received 23-mm valves. Functional improvement in New York Heart Association functional class was observed in 93.5% of patients. Mean peak conduit gradient decreased from 37.5 ± 25.4 to 17.8 ± 12.4 mm Hg (p < 0.001), and mean right ventricular systolic pressure decreased from 59.6 ± 17.7 to 42.9 ± 13.4 mm Hg (p < 0.001). Pulmonary regurgitation was mild or less in 91.1% of patients. Freedom from all-cause mortality at 3 years was 98.4%. Freedom from reintervention was 93.7% and from endocarditis was 97.1% at 3 years. There were no observed stent fractures. CONCLUSIONS: Transcatheter pulmonary valve replacement using the Edwards SAPIEN THV demonstrates excellent valve function and clinical outcomes at 3-year follow-up.

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Published In

JACC Cardiovasc Interv

DOI

EISSN

1876-7605

Publication Date

October 8, 2018

Volume

11

Issue

19

Start / End Page

1920 / 1929

Location

United States

Related Subject Headings

  • Young Adult
  • Ventricular Outflow Obstruction
  • United States
  • Treatment Outcome
  • Time Factors
  • Risk Factors
  • Recovery of Function
  • Pulmonary Valve Insufficiency
  • Pulmonary Valve
  • Prosthesis Design
 

Citation

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Kenny, D., Rhodes, J. F., Fleming, G. A., Kar, S., Zahn, E. M., Vincent, J., … Hijazi, Z. M. (2018). 3-Year Outcomes of the Edwards SAPIEN Transcatheter Heart Valve for Conduit Failure in the Pulmonary Position From the COMPASSION Multicenter Clinical Trial. JACC Cardiovasc Interv, 11(19), 1920–1929. https://doi.org/10.1016/j.jcin.2018.06.001
Kenny, Damien, John F. Rhodes, Gregory A. Fleming, Saibal Kar, Evan M. Zahn, Julie Vincent, Girish S. Shirali, et al. “3-Year Outcomes of the Edwards SAPIEN Transcatheter Heart Valve for Conduit Failure in the Pulmonary Position From the COMPASSION Multicenter Clinical Trial.JACC Cardiovasc Interv 11, no. 19 (October 8, 2018): 1920–29. https://doi.org/10.1016/j.jcin.2018.06.001.
Kenny D, Rhodes JF, Fleming GA, Kar S, Zahn EM, Vincent J, et al. 3-Year Outcomes of the Edwards SAPIEN Transcatheter Heart Valve for Conduit Failure in the Pulmonary Position From the COMPASSION Multicenter Clinical Trial. JACC Cardiovasc Interv. 2018 Oct 8;11(19):1920–9.
Kenny, Damien, et al. “3-Year Outcomes of the Edwards SAPIEN Transcatheter Heart Valve for Conduit Failure in the Pulmonary Position From the COMPASSION Multicenter Clinical Trial.JACC Cardiovasc Interv, vol. 11, no. 19, Oct. 2018, pp. 1920–29. Pubmed, doi:10.1016/j.jcin.2018.06.001.
Kenny D, Rhodes JF, Fleming GA, Kar S, Zahn EM, Vincent J, Shirali GS, Gorelick J, Fogel MA, Fahey JT, Kim DW, Babaliaros VC, Armstrong AK, Hijazi ZM. 3-Year Outcomes of the Edwards SAPIEN Transcatheter Heart Valve for Conduit Failure in the Pulmonary Position From the COMPASSION Multicenter Clinical Trial. JACC Cardiovasc Interv. 2018 Oct 8;11(19):1920–1929.
Journal cover image

Published In

JACC Cardiovasc Interv

DOI

EISSN

1876-7605

Publication Date

October 8, 2018

Volume

11

Issue

19

Start / End Page

1920 / 1929

Location

United States

Related Subject Headings

  • Young Adult
  • Ventricular Outflow Obstruction
  • United States
  • Treatment Outcome
  • Time Factors
  • Risk Factors
  • Recovery of Function
  • Pulmonary Valve Insufficiency
  • Pulmonary Valve
  • Prosthesis Design