The first-ever clinical data, from an early feasibility study, indicate that Medtronic’s Harmony transcatheter pulmonary calve is associated with positive initial outcomes at six-months in patients with an indication for pulmonary valve restoration. The initial results were presented at 2-16 American College of Cardiology (ACC; 2–4 April, Chicago, USA). Following these positive initial data, a pivotal Investigational Device Exemption (IDE) study is planned to start in late calendar year 2016, pending approval from the FDA.
A press release reports that the first-of-its-kind early feasibility study was initiated by Medtronic in close collaboration with the FDA in an effort to develop a minimally invasive alternative to open-heart surgery for patients with congenital heart disease. It adds that approximately one in five patients born with congenital heart disease have an abnormality of their right ventricular outflow tract. In these patients, there are primarily two options currently used to facilitate blood flow from the heart to the lungs—an open surgical valve replacement (80%) or an open surgical valve-conduit implant (20%). In the latter case, when the conduit fails, a non-surgical valve such as the globally approved Melody transcatheter pulmonary valve may be an option. According to the press release, the Harmony device may prove to be a less invasive option for approximately 80% of patients who currently undergo initial open heart surgical valve replacement to restore normal valve function.
The early feasibility study for the Harmony device is a non-randomized, prospective study at two sites in the USA and one in Canada. The study included a rigorous patient selection process to identify 20 patients for implant and follow-up out to five years. Due to the highly variable anatomy of the patient population, the study required careful screening to ensure the optimal fit.
Of the patients followed out to six months (N=18), severe pulmonary regurgitation improved from 95% pre-implant to 0% at six months. Additionally, mean right ventricular outflow tract gradients were consistent and stable from 13.2 ± 5.1mmHg at discharge and 15.4 ± 5.6mmHg at six months. Some gradients are expected in this patient population due to the right side of the heart having free-blood flow before the valve is implanted.
John Cheatham (The Heart Center, Nationwide Children’s Hospital, Columbus, USA), who presented the data the ACC, comments: “Through precise patient selection, the early feasibility data enables the clinical community to gather several key insights that will help to determine the valve’s therapeutic benefits in this patient population. Due to its unique design and ability to adapt to a wide variety of patient anatomies, the Harmony valve and its future iterations may provide a broad range of congenital heart disease patients with a minimally invasive treatment option that allows for shorter procedural time and hospital stay.”