Mid-Term Outcomes Following Percutaneous Pulmonary Valve Implantation Using the "Folded Melody Valve" Technique

Abstract

Background: The folded valve is a manual shortening of the Melody device, which has been validated as a valuable therapeutic option for the management of dysfunctional right ventricular outflow tracts needing a short valved stent. In this article, we aimed to evaluate, in a multicenter cohort, the mid-term outcomes of patients in whom a percutaneous pulmonary valve implantation was performed using the folded valve technique.

Methods: A 2012 to 2018 retrospective multicenter study was performed in 7 European institutions. All patients who benefit from percutaneous pulmonary valve implantation with a folded Melody valve were included.

Results: A total of 49 patients (median age, 19 years [range 4–56], 63% male) were included. The primary percutaneous pulmonary valve implantation indication was right ventricular outflow tract stenosis (n=19; 39%), patched native right ventricular outflow tracts were the most common substrate (n=15; 31%). The folded technique was mostly used in short right ventricular outflow tracts (n=28; 57%). Procedural success was 100%. After a median follow-up of 28 months (range, 4–80), folded Melody valve function was comparable to the immediate postimplantation period (mean transvalvular peak velocity=2.6±0.6 versus 2.4±0.6 m/s, P>0.1; only 2 patients had mild pulmonary regurgitation). Incidence rate of valve-related reinterventions was 2.1% per person per year (95% CI, 0.1%–3.9%). The probability of survival without valve-related reinterventions at 36 months was 90% (95% CI, 76%–100%).

Conclusions: The folded Melody valve is a safe technique with favorable mid-term outcomes up to 6.5 years after implantation, comparable with the usual Melody valve implantation procedure. Complications and reinterventions rates were low, making this technique relevant in selected patients.

Keywords: incidence; probability; pulmonary valve; retrospective; stent.

Figure 1.

Folded Melody valve implantation in a short right ventricular outflow tract (RVOT) with early pulmonary artery (PA) bifurcation. Twelve-y-old patient with operated common arterial trunk presenting with stenotic lesion of 14-mm Contegra conduit. A–D, Cardiac computed tomography reconstructions (A and B) and angiograms (C and D) showing severe conduit stenosis with short landing zone (white arrows) before PA bifurcation; E and F, angiograms showing RVOT prestenting with a 26-mm Intrastent LD Max (ev3 Endovascular, Inc, Plymouth, MN; white asterisk); G and H, Final angiogram after folded Melody valve implantation showing good valve function without PA jailing. LPA indicates left pulmonary artery; RPA, right pulmonary artery; and RVOT, right ventricular outflow tract.

Figure 2.

Folded Melody valve implantation in right ventricular outflow tract (RVOT) with coronary artery proximity. A and B, Simultaneous RVOT and selective coronary angiograms showing a close proximity between the coronary arteries and distal RVOT. C and D, Selective coronary angiogram after folded Melody valve implantation showing coronary artery patency.

Figure 3.

Kaplan-Meier curves of reinterventions-free survival among the study period. Plots of reintervention-free survival for all-cause reinterventions (A) and valve-related interventions (B). FU indicates follow-up.

Figure 4.

Stent fracture following folded Melody valve implantation. The procedure was performed in the setting of an infective endocarditis with obstructive lesion of the valve. A and B, Angiograms showing moderate pulmonary regurgitation and valvular obstruction. Proximal stent fracture is visible (white arrow). C and D, Contrast-free fluoroscopies showing folded Melody stent fracture (white circles).

Figure 5.

Valve-in-valve procedure following severe noninfectious obstruction of a folded Melody. A and B, Angiograms showing moderate pulmonary regurgitation and valvular obstruction with contrast-media filling defect (white arrows) at the level of the valve, without stent fractures. C, Angiographic result following Melody valve in valve implantation.