New-look TAVR valve recently acquired by Edwards may reduce risk of coronary obstruction
![Performing transcatheter aortic valve replacement (TAVR) with the J-Valve transcatheter heart valve (THV) may help limit the risk of coronary artery obstruction (CAO) in high-risk patients, according to a new study published in Clinical Interventions in Aging.[1]](/sites/default/files/styles/top_stories/public/2024-10/screenshot_2024-10-01_at_2.16.21_pm.png.webp?itok=kSiGReBW)
Performing transcatheter aortic valve replacement (TAVR) with a new transcatheter heart valve (THV) may help limit the risk of coronary artery obstruction (CAO) in high-risk patients, according to a new study published in Clinical Interventions in Aging.[1]
Previous research had suggested the J-Valve THV from Jianshi Medical/JC Medical could potentially reduce a patient’s risk of CAO. The study’s authors explained that this potential is due to the device’s “self-positioning” design, which includes a crown-like frame and three specific pieces designed to assist operators with commissural alignment.
J-Valve at center of recent Edwards acquisition
Edwards Lifesciences recently agreed to acquire JC Medical from Genesis MedTech for an undisclosed upfront payment and an additional equity investment of $25 million. However, Genesis MedTech kept the rights to develop, manufacture and commercialize the J-Valve technology in China.
Early data on high-risk TAVR patients
This new analysis focused on 20 TAVR patients treated at the same academic hospital in China from January 2015 to July 2021. The mean age was 72 years old, 85% of patients were female and the median Society of Thoracic Surgeons risk score was 5%. All patients presented with multiple risk factors associated with CAO.
Preprocedural multislice computed tomography was performed on every patient at baseline. In addition, transthoracic echocardiograms were performed at baseline and 30 days following treatment. Patients were excluded in cases of poor imaging quality or the use of other TAVR devices. All TAVR procedures were performed using transapical access, which is more invasive than transfemoral access. A separate ongoing clinical trial is presently evaluating the safety of performing transfemoral TAVR with the device.
Overall, TAVR with the J-Valve device was successful in 95% of patients. A single participant required a second device. After 30 days, all patients were still alive and free from CAO, stroke or emergency reintervention after 30 days. The post-procedural mean aortic valve gradient was 7 mmHg.
“The J-Valve has been validated for aortic stenosis and/or regurgitation treatment,” wrote corresponding author Lai Wei, with the department of cardiovascular surgery at Zhongshan Hospital in China, and colleagues. “Compared to current techniques for CAO, TAVR using J-Valve can avoid the need for additional interventions, resulting in less fluoroscopy time and contrast dose, and reducing the risk of stroke and stent thrombosis. However, transapical access is more invasive, requiring general anesthesia and mini-thoracotomy, which restricts the use of J-Valve for coronary artery protection.”
The researchers added that better prediction models for anticipating CAO are still needed. Until then, they wrote, these “promising outcomes” suggest TAVR manufacturers may learn something from the J-Valve’s design.
This analysis was not funded by any specific vendors. Click here for the full study.
Michael has more than 16 years of experience as a professional writer and editor. He has written at length about cardiology, radiology, artificial intelligence and other key healthcare topics.