Since 2007, accumulated data on the Melody TPV and Ensemble Delivery System consistently demonstrates excellent clinical results. The data presented below is from these three studies.
Prospective, non-randomized investigational study conducted at 5 centers. 150 subjects implanted between January 2007 and January 2010; patients will be followed for 10 years. Data presented is interim results current through March 1, 2014 (mean length of follow-up 4.4 ± 1.3 years).
Prospective, non-randomized study conducted at 10 centers. 100 subjects implanted between July 2010 and July 2012; patients will be followed for 5 years. Data presented is interim results through March 1, 2014 (mean length of follow-up 2.1 ± 0.8 years).
Prospective, non-randomized study conducted at 7 centers in Europe and Canada. 63 subjects implanted between October 2007 and April 2009; patients will be followed for 5 years. Data presented is interim results through March 1, 2014 (mean length of follow-up 4.2 ± 1.1 years).
Low rates of surgical conduit reoperation out to 5 years.
Freedom from catheter-based re-intervention on the TPV was greater than 80% out to 5 years.
Following Melody TPV implant the mean RVOT gradients decreased and remained consistent throughout follow-up in all 3 studies.
The majority of subjects in all 3 studies had a moderate or severe pulmonary regurgitation at baseline. Throughout follow-up, the majority of subjects had no more than trace pulmonary regurgitation.
Consistently high rates of successful valve implantation across the three studies including strong hemodynamics and low incidence of procedural adverse events. Procedural success is a composite outcome defined as:
*3 subjects were not assessed for one or more of the composite variables and were considered a procedural failure.
The safety profile of the Melody valve remains out to 5 years as evidenced by low rates of serious device-related adverse events across all categories.
At baseline, the majority of subjects in all 3 studies were in NYHA class II/III. Following Melody TPV implant, the majority of subjects were in NYHA class I, which remained consistent during follow-up.
In the PMSS, Quality of Life (QoL) Assessments utilizing the EQ-5D were obtained at baseline and annually throughout follow-up. The EQ-5D Health State demonstrated early improvements that were sustained through follow-up in most categories (Difficulties with Mobility, Problems with Usual Activities, Pain or Discomfort, and Anxiety or Depression).
The EQ-5D is a standardized instrument for use as a measure of health outcome applicable to a wide range of health conditions and treatments. It provides a simple descriptive profile and a single index value for health status.
A higher Health State score represents an improvement in QoL.