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Medtronic offers 10-year data, pivotal trial update on transcatheter pulmonary valves.

Medtronic on Friday highlighted newly released data on two transcatheter pulmonary valve devices, one study tracking outcomes in congenital heart disease patients a decade after implant and the other offering a look at an on going trial evaluating a potential new CHD treatment. The results were presented at the virtual meeting of the Society for Cardiovascular Angiography and Interventions (SCAI).

Ten-year data for the Melody valve in 150 patients demonstrated that freedom from valve dysfunction, the primary endpoint of the study, was 54%. That figure is in line with long-term surgical outcomes in similar patient populations, according to SCAI.

The investigational Harmony valve met safety and effectiveness endpoints for freedom from procedure- or device-related mortality and hemodynamic function at six months.

The Melody device was developed to treat narrowed or leaking pulmonary valve conduits between the heart’s right chamber and the lungs in patients who have already had open heart surgery for a congenital defect. The catheter-placed device is designed to extend the life of a failing pulmonary valve conduit with a less-invasive treatment, delaying the need for an additional operation.

Researchers found a significant difference by age on the primary goal of freedom from transcatheter valve dysfunction, defined as repeat operation, repeat catheter intervention, or moderate or greater pulmonary regurgitation. After 10 years of follow-up, 65% of adults were free of transcatheter pulmonary valve dysfunction. But in pediatric age patients, only 47% of individuals in the study met the endpoint. The median age of patients in the study was 19 years.

Freedom from all-cause mortality was 90%, while 79% of patients were free from repeat surgical intervention and 72% were free from catheter intervention. Freedom from major stent fracture was 84% after 10 years, and 61% of patients did not require a repeat intervention.

The SCAI report concluded that the Melody valve fulfilled its aim of prolonging the life of surgically implanted right ventricular outflow tract conduits and bio-prosthetic valves while reducing the lifetime burden of repeat open heart operations.

“While the data reinforces the longevity, durability, and efficacy of the Melody TPV, it will also serve as a study model for future evaluations of novel pediatric congenital heart disease technologies," said Thomas K. Jones, director of cardiac catheterization at Seattle Children’s in Washington, in a statement put out by SCAI. Jones has received consulting fees and other payments from the company.

In the second dataset presented at the SCAI meeting, researchers evaluated Medtronic's Harmony transcatheter pulmonary valve in patients with severe pulmonary regurgitation whose median age was 28 years. The condition, in which blood flows back into the heart chamber before it can reach the lungs, can occur after the failed surgical correction of an obstructed right ventricular outflow tract.

Acceptable hemodynamic function was reported at six months in 89% of the pivotal trial participants. The primary endpoint set a hemodynamic function performance target of 75% for patients in both the pivotal trial and the early feasibility study; that goal was met in 91% of patients.

The study also found 84% of patients were free from device failure at six months, 94% had either no pulmonary regurgitation or a mild form, and 97% had no or mild paravalvular leaking.

Medtronic plans to report its fiscal fourth-quarter financial results on Thursday. The medtech giant has warned investors to be prepared for a negative effect on earnings as the COVID-19 pandemic forced hospitals to defer many elective procedures that use the company's products.

Author: Susan Kelly

Published: May 18, 2020

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