Health Care Professionals   |   United States

Medtronic

Melody®
Transcatheter pulmonary valve (TPV) Therapy

Substantial Clinical Evidence

Melody TPV Clinical Experience

Melody TPV Clinical Experience


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.

US IDE Study

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).

US Post Approval Study (PAS)

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).

European and Canadian Post-Market Surveillance Study (PMSS)

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).

Proven Performance

Delays Patient’s Next Surgical Intervention

Low rates of surgical conduit reoperation out to 5 years.

Delays Patient’s Next Surgical Intervention

Freedom from Catheter Re-intervention

Freedom from catheter-based re-intervention on the TPV was greater than 80% out to 5 years.

Freedom from Catheter Re-intervention

Excellent Valve Performance

Low RVOT Gradients

Following Melody TPV implant the mean RVOT gradients decreased and remained consistent throughout follow-up in all 3 studies.

Low RVOT Gradients

Minimal Regurgitation

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.

Minimal Regurgitation

Procedural Success and Strong Safety Profile

High Rates of Acute Procedural Success

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:

  • Melody TPV was successfully delivered to the intended location
  • RV-PA peak-to-peak gradient (measured in the catheterization lab) less than 35mmHg post implant
  • Less than mild pulmonary regurgitation
  • Free of explant at 24 hours post implant
High Rates of Acute Procedural Success

*3 subjects were not assessed for one or more of the composite variables and were considered a procedural failure.

Low Rates of Device-Related Adverse Events

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.

Low Rates of Device-Related Adverse Events

Quality of Life Improvements

Improves Functional Status

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.

Improves Functional Status

Improves Quality of Life

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).

Improves Quality of Life

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.


References

  1. McElhinney DB, Cheatham JP, Jones TK, et al. Stent fracture, valve dysfunction, and right ventricular outflow tract reintervention after transcatheter pulmonary valve implantation: patient-related and procedural risk factors in the US Melody Valve Trial. Circ Cardiovasc Interv. 2011 Dec 1;4(6):602-14. Epub 2011 Nov 9.
  2. McElhinney DB, Hellenbrand WE, Zahn EM, et al. Short- and medium-term outcomes after transcatheter pulmonary valve placement in the expanded multicenter US melody valve trial. Circulation. 2010;122:507-16.
  3. Armstrong AK, Balzer DT, Cabalka AK, et al. One-year follow-up of the Melody transcatheter pulmonary valve multicenter post-approval study. JACC Cardiovasc Interv. 2014 Nov;7(11):1254-62.
  4. Lurz P, Coats L, Khambadkone S, et al. Percutaneous pulmonary valve implantation: impact of evolving technology and learning curve on clinical outcome. Circulation. 2008 Apr 15;117(15):1964-72. Epub 2008 Apr 7.
  5. Eicken A, Ewert P, Hager A, et al. Percutaneous pulmonary valve implantation: two-centre experience with more than 100 patients. Eur Heart J. 2011 May;32(10):1260-5. Epub 2011 Jan 27.
  6. Butera G, Milanesi O, Spadoni I, et al. Melody transcatheter pulmonary valve implantation. Results from the registry of the Italian Society of Pediatric Cardiology (SICP). Catheter Cardiovasc Interv. 2012 Jun 21. doi: 10.1002/ccd.24518. [Epub ahead of print].
  7. Vezmar M, Chaturvedi R, Lee KJ, et al. Percutaneous pulmonary valve implantation in the young 2-year follow-up. JACC Cardiovasc Interv. 2010 Apr;3(4):439-48.
  8. Fraisse A, Aldebert P, Malekzadeh-Milani S, et al. Melody transcatheter pulmonary valve implantation: Results from a French registry. Arch Cardiovasc Dis. 2014 Nov;107(11):607-14. doi: 10.1016/j.acvd.2014.10.001. Epub 2014 Nov 6.

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Brochure

Melody TPV Product Brochure
(English)