Follow-up Results for Harmony TPV System Demonstrate Efficacy at 1-Year

Conference | <b>Society for Cardiovascular Angiography and Interventions</b>

Results of 1-year follow-up from the Harmony TPV Clinical trial provide insight into the safety and efficacy of the recently approved Harmony TPV system in patients with congenital heart disease and severe pulmonary regurgitation.

Research presented at the Society for Cardiovascular Angiography and Interventions (SCAI) 2021 Scientific Sessions is providing clinicians with further insight into the effectiveness of Medtronic Harmony transcatheter pulmonary valve (TPV) system in patients with congenital heart disease (CHD) and severe pulmonary regurgitation.

Approved by the US Food and Drug Administration in March 2021, results presented at SCAI 2021 detail the 1-year outcomes from the pivotal trial and 30-day outcomes from the continued access study examining Harmony TPV

“This is a brand-new class of cardiac devices designated to help a very specific patient population where no less-invasive, percutaneous treatment options were available until now,” said Thomas Jones, MD, principal investigator of the trial and director of Cardiac Catheterization Laboratories at Seattle Children’s Hospital, in a statement. “Unlike any other TPV, this novel technology is designed to expand into the enlarged RVOT in these patients while simultaneously deploying a suitable bioprosthetic pulmonary valve. The Harmony TPV system has the potential to fundamentally alter the lifetime management of CHD patients from here on out.”

The first non-surgical heart valve approved in any country to treat pediatric and adult patients with a native or surgically-repaired right ventricular outflow tract (RVOT), the Harmony TPV system stands poised to fill an unmet in need patients with CHD. With the FDA basing their approval partially on 6-month data from the Harmony TPV Clinical Study, which was designed as a prospective, non-randomized, multicenter study, the 1-year outcomes data was among the most anticipated information to be released at SCAI 2021.

Conducted in 12 centers in the US, Canada, and Japan, the pivotal trial enrolled 31 patients, 21 to TPV22 and 10 to TPV25, and the continued access study enrolled 37 patients, 1 to TPV22 and 36 to TPV25. Investigators noted 1 implant in the continued access study was unsuccessful. The mean follow-up times were 21.7±10.1 and 2.3±2.1 months for patients in the pivotal trial and continued access study, respectively.

Highlighted Data Points:

  • All pivotal trial patients survived to 1-year follow-up.
  • All pivotal trial patients were free from pulmonary regurgitation at 1-year.
  • Greater than 90% of patients had none/trace pulmonary regurgitation at all follow-up visits.
  • Zero explants or instances of endocarditis, major stent fractures, or thrombosis.
  • Two patients in the continued access study required reintervention or reoperation.
    • One required implantation of another TPV
    • One required balloon angioplasty of the distal device
  • Five patients had stable, non-sustained ventricular tachycardia after implant that resolved and did not appear to be clinically important.

This study, “The Harmony Transcatheter Pulmonary Valve: 1-Year Outcomes from the Pivotal Trial and 30-Day Outcomes from the Continued Access Study,” was presented at SCAI 2021.