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The Melody valve is the longest studied transcatheter pulmonary valve (TPV), with the largest body of clinical evidence. Accumulated data have consistently demonstrated excellent clinical results, including high rates of freedom from surgical reoperation, confirming the Melody TPV safely and effectively delays the need for surgical conduit exchange.
Prospective, non-randomized investigational study conducted at five centers in the United States. One hundred fifty (150) subjects implanted between January 2007 and January 2010; patients will be followed for 10 years. Data presented are interim results current through June 2016.
Prospective, non-randomized study conducted at 10 centers in the United States. One hundred (100) subjects implanted between July 2010 and July 2012; patients will be followed for 5 years. Data presented are interim results through June 2016.
Prospective, non-randomized study conducted at seven centers in Europe and Canada. Sixty-three (63) subjects implanted between October 2007 and April 2009; patients were followed for 5 years. Data presented are final results as of August 2016.
Study | # of Centers | # of Patients | First Implant | Last Implant | Mean Length of Follow-up |
---|---|---|---|---|---|
US IDE | 5 | 150 | 2007 | 2010 | 6.1 ± 1.7 years |
US PAS | 10 | 100 | 2010 | 2012 | 3.8 ± 1.2 years |
EU/CA PMSS | 7 | 63 | 2007 | 2009 | 4.7 ± 1.1 years |
U.S. Investigational Device Exemption Study (IDE) | U.S. Post Approval Study (PAS) | EU/CA Post-Market Surveillance Study (PMSS)
Low rates of surgical conduit reoperation out to 8 years.
Freedom from catheter-based re-intervention on the TPV was greater than 78% out to 8 years.
Following Melody TPV implant the mean right ventricle outflow tract (RVOT) gradients decreased and remained consistent throughout follow-up in all three studies.
Mean RVOT Gradient By Time Interval |
Baseline | 1 Year | 3 Year | 5 Year | 7 Year |
---|---|---|---|---|---|
US IDE (N=149) |
32.1 ± 13.9 | 18.7 ± 9.1 | 17.6 ± 7.9 | 17.5 ± 8.4 | 17.9 ± 9.8 |
US PAS (N=99) |
33.4 ± 14.1 | 15.1 ± 7.1 | 16.7 ± 10.8 | 14.4 ± 12.6 | -- |
EU/CA PMSS (N=62) |
37.7 ± 12.1 | 17.9 ± 9.2 | 17.3 ± 8.4 | 17.3 ± 9.7 | - |
The majority of subjects in all three studies had moderate or severe pulmonary regurgitation at baseline. Throughout follow-up, the majority of subjects had no more than trace pulmonary regurgitation.
The safety profile of the Melody TPV has remained unchanged through the longer-term follow-up data and broader implanter base in the Medtronic studies, demonstrated by the low rates of procedural and device-related serious adverse events.
Studies show consistently high rates of successful valve implantation, including strong hemodynamics and low incidence of procedural adverse events.
Procedural success is a composite outcome defined as:
Study | Procedural Success |
---|---|
US IDE (N=149) | 94.7% |
US PAS (N=99) | 92.1% |
EU/CA PMSS (N=62) | 88.7% |
The safety profile of the Melody valve remains out to 7 years as evidence by low rates of serious device-related adverse events across all studies.
Event | US IDE Freedom from event at 7 years (CI) (N=149) |
US PAS Freedom from event at 5 years (CI) (N=99) |
EU/CA PMSS Freedom from event at 5 years (CI) (N=62) |
---|---|---|---|
Stent Fracture: Major | 83.6% (75.7%, 89.2%) |
91.0% (81.3%, 95.8%) |
91.6% (81.1%, 96.4%) |
Valve Dysfunction: Stenosis | 79.3% (70.8%, 85.7%) |
86.1% (76.1%, 92.1%) |
82.3% (69.5%, 90.1%) |
Valve Dysfunction: Regurgitation | 99.3% (95.4%, 99.9%) |
88.7% (75.8%, 94.9%) |
98.3% (89.4%, 99.7%) |
Prosthetic Valve Endocarditis | 89.2% (79.7%, 94.4%) |
84.9% (73.9%, 91.5%) |
93.2% (82.6%, 97.4%) |
Embolization of the TPV | 100.0% (NA) |
100.0% (NA) |
100.0% (NA) |
At baseline, the majority of subjects in all three studies were NYHA class II/III. Following Melody TPV implant, the majority of subjects were in NYHA class I, which remained consistent during follow-up.
Data pooled from two U.S. prospective studies that included both failed conduits and BPVs and one retrospective study assessing Melody in dysfunctional BPVs only, demonstrated safety and effectiveness in restoring pulmonary valve function without open heart surgery.
The following outcomes demonstrate the safety and effectiveness of the Melody TPV implanted in a bioprosthetic pulmonary valve (BPV) restoring pulmonary valve competency while delaying the need for surgical intervention.
Variable |
Bioprosthesis (n=125) Number of Subjects in the Analysis |
Bioprosthesis (n=125) Endpoint Rate |
RVOT Conduit (n=225) Number of Subjects in the Analysis |
RVOT Conduit (n=225) Endpoint Rate |
---|---|---|---|---|
Procedural success |
117 | 88.9% (82.9%, 93.3%) |
225 | 93.8% (90.4%, 96.2%) |
Procedure-related serious AE at 1 year |
125 | 4.0% (2.6%, 10.1%) |
225 | 12.4% (12.0%, 20.0%) |
Device-related serious AE at 1 year |
125 | 2.4% (0.6%, 6.0%) |
225 | 16.0% (16.7%, 25.6%) |
The confidence intervals are exact (Clopper-Pearson) confidence intervals for the binomial proportion.
Variable |
Bioprosthesis (n=125) Number of |
Bioprosthesis (n=125) 1-year |
RVOT Conduit (n=225) Number of |
RVOT Conduit (n=225) 1-year |
---|---|---|---|---|
TPV Dysfunction |
125 | 97.4% (90.0%, 99.4%) |
223 | 94.1% (90.1%, 96.6%) |
Reoperation | 125 | 100.0% (NA) |
223 | 98.6% (95.9%, 99.6%) |
Reintervention | 125 | 100.0% (NA) |
223 | 98.2% (95.2%, 99.3%) |
All-Cause Mortality
|
125 | 100.0% (NA) |
223 | 99.6% (96.8%, 99.9%) |
Major Stent
Fracture
|
125 | 100.0% (NA) |
223 | 97.7% (94.6%, 99.1%) |
Endocarditis | 125 | 100.0% (NA) |
223 | 97.3% (94.0%, 98.8%) |
The cumulative probability of event free estimate is based on the Kaplan-Meier method.
The 95% confidence interval is the loglog transformed 95% Confidence Interval (CI) using the Peto standard error.