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Transcatheter pulmonary valve replacement using the melody valve for treatment of dysfunctional surgical bioprostheses: A multicenter study  Allison K.

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Presentation on theme: "Transcatheter pulmonary valve replacement using the melody valve for treatment of dysfunctional surgical bioprostheses: A multicenter study  Allison K."— Presentation transcript:

1 Transcatheter pulmonary valve replacement using the melody valve for treatment of dysfunctional surgical bioprostheses: A multicenter study  Allison K. Cabalka, MD, Jeremy D. Asnes, MD, David T. Balzer, MD, John P. Cheatham, MD, Matthew J. Gillespie, MD, Thomas K. Jones, MD, Henri Justino, MD, Dennis W. Kim, MD, PhD, Te-Hsin Lung, PhD, Daniel R. Turner, MD, Doff B. McElhinney, MD  The Journal of Thoracic and Cardiovascular Surgery  Volume 155, Issue 4, Pages e1 (April 2018) DOI: /j.jtcvs Copyright © 2017 The American Association for Thoracic Surgery Terms and Conditions

2 Figure 1 Age at the time of transcatheter pulmonary valve replacement (TPVR) (A), age of the bioprosthetic valve (BPV) (B), and pre-TPVR mean Doppler right ventricular outflow tract (RVOT) gradient (C), stratified by BPV size group. Age at the time of TPVR was significantly associated with BPV size (P < .001), as was pre-TPVR mean RVOT gradient (P = .01). There was no significant association with age of the BPV (P = .78). The box is centered at the median, with upper and lower bounds of the box representing the 75th and 25th percentiles. The upper and lower ends of the whiskers are at 1.5 interquartile range (IQR) from the 75th or 25th percentile, respectively, or at the maximum of the observations, whichever is smaller. Circles represent values 1.5 IQR above 75th percentile or 1.5 IQR below 25th percentile. The ◊ is the mean of the observations. There was 1 outlier, age 79 years, in the 25 mm BPV group, not shown in the figure. The Journal of Thoracic and Cardiovascular Surgery  , e1DOI: ( /j.jtcvs ) Copyright © 2017 The American Association for Thoracic Surgery Terms and Conditions

3 Figure 2 Kaplan–Meier curves depicting freedom from transcatheter pulmonary valve dysfunction (A) and freedom from a mean right ventricular outflow tract gradient >35 mm Hg (B). Vertical bars represent 95% confidence intervals at 6, 12, and 24 months. TPV, Transcatheter pulmonary valve; RVOT, right ventricular outflow tract. The Journal of Thoracic and Cardiovascular Surgery  , e1DOI: ( /j.jtcvs ) Copyright © 2017 The American Association for Thoracic Surgery Terms and Conditions

4 Figure 3 Doppler mean right ventricular outflow tract gradient over time overall (A), according to bioprosthetic valve (BPV) size (B), and in patients age ≥18 years by BPV size (C). Values are shown as mean ± standard deviation, represented by error bars. Patients with missing valve size or who did not have an echocardiogram at a given time point are not included. In B and C, P values are nonsignificant between ≤23 mm and ≥25 mm at all follow-up time points. RVOT, Right ventricular outflow tract. The Journal of Thoracic and Cardiovascular Surgery  , e1DOI: ( /j.jtcvs ) Copyright © 2017 The American Association for Thoracic Surgery Terms and Conditions

5 Figure 4 Severity of pulmonary regurgitation before implantation, at discharge, and on the most recent echocardiogram (median follow-up duration from implantation to the last available echocardiogram for 72 of the 100 patients with evaluable echocardiographic data, 1.6 years; range,  years). The Journal of Thoracic and Cardiovascular Surgery  , e1DOI: ( /j.jtcvs ) Copyright © 2017 The American Association for Thoracic Surgery Terms and Conditions

6 Figure E1 BPV retrospective study patient disposition. In total, 130 Melody TPV implantations in the pulmonary position were performed during the study period, and 100 patients were enrolled in the retrospective study. Reasons why 30 patients were not enrolled are shown. In 24 of the 100 enrolled patients, the valve was implanted for <1 year; duration of follow-up for the remaining patients is detailed in the flow chart. *The Institutional Review Board (IRB) at 4 sites required informed consent and/or subject notification of data use. †One patient died at a site that required informed consent. Because consent could not be obtained, this patient was not included in the data analysis. ‡The IRB did not allow the enrollment of 1 patient based on the date of implantation in relation to humanitarian device exemption discontinuation and premarket approval of the Melody TPV. The Journal of Thoracic and Cardiovascular Surgery  , e1DOI: ( /j.jtcvs ) Copyright © 2017 The American Association for Thoracic Surgery Terms and Conditions

7 Fluoroscopic image of an adult who underwent TPVR with a Melody valve for severe PR and mild stenosis of a 27-mm Mosaic valve at 8 years after surgical PV replacement. The Melody valve is implanted on a 22-mm delivery system into the existing BPV, with a mild residual waist. The Journal of Thoracic and Cardiovascular Surgery  , e1DOI: ( /j.jtcvs ) Copyright © 2017 The American Association for Thoracic Surgery Terms and Conditions

8 Video 1 A case of Melody valve implantation into an existing 21-mm Hancock bioprosthetic valve in a 16-year-old female with previous tetralogy of Fallot repair. A 20-mm Melody valve was placed into the valve using a 20-mm Ensemble delivery system, and postdilation was performed with an 18-mm Atlas high-pressure balloon. The postimplantation gradient was 13 mm Hg, with trivial pulmonary regurgitation. Intracardiac echo imaging was used to assess the valve function before and after Melody implantation. Video available at: The Journal of Thoracic and Cardiovascular Surgery  , e1DOI: ( /j.jtcvs ) Copyright © 2017 The American Association for Thoracic Surgery Terms and Conditions

9 The Journal of Thoracic and Cardiovascular Surgery 2018 155, 1712-1724
The Journal of Thoracic and Cardiovascular Surgery  , e1DOI: ( /j.jtcvs ) Copyright © 2017 The American Association for Thoracic Surgery Terms and Conditions


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