Evan Zahn (Guerin Family Congenital Heart Program, Cedars-Sinai Heart Institute, Los Angeles, USA) has become the first interventional cardiologist to implant the Alterra adaptive prestent device (Edwards Lifesciences) to reshape the right ventricular outflow tract (RVOT) of a patient’s malformed pulmonary valve. The procedure was the first in a new, early feasibility clinical trial that has been approved by the FDA.
According to a press release, Alterra is a self-expanding, stent-like implant that conforms to a wide range of pulmonary artery anatomies and can be delivered with a transcatheter approach. It is designed to reshape the RVOT to provide a “landing zone” for a replacement transcatheter valve (such as the Sapien 3, Edwards Lifesciences).
The press release reports that use of the device could spare patients with a common congenital malformed pulmonary valve from undergoing multiple open-heart surgeries. Zahn comments: “These patients, typically require multiple open-heart surgeries over the course of their lifetime, and in between surgeries, this condition is quietly causing significant damage to their heart that may ultimately result in heart failure and a premature death. There is a great need to find a solution we hope will yield better results, fewer repeat surgeries—and have patients going home more quickly.”
Zahn is the lead investigator for the multicentre, national clinical trial that is sponsored by Edwards.