India-based Meril Life Sciences has been manufacturing its Myval transcatheter heart valves for years, but the technology has not yet gained FDA approval. This latest head-to-head comparison included data from more than 1,000 TAVR patients.

Deepak Bhatt, MD, detailed several recent clinical trials that could reshape the way clinicians manage acute coronary syndrome (ACS) patients.

Paravalvular leak has been shown to impact patient outcomes after TAVR. Higher degrees of valve oversizing, however, can reduce the risk of post-treatment PVL without increasing the odds of adverse outcomes.

Researchers tracked nearly 1,000 SAVR patients, presenting eight-year data at the Heart Valve Society’s annual meeting in Cairo, Egypt. 

A catheter sheath detached during use and was left in the patient’s body. It was successfully removed, but the FDA said it is now evaluating the potential risk to others going forward. There is no official recall at this time.

“The device takes variability out of the procedure by giving the operator full control while automating ramp-up and back-up algorithms," according to a clinician who used the new technology. "The TAVR procedure is simplified, reducing physician and staff workload."

Real-world patients were still associated with "excellent" outcomes, but it is important for cardiologists and patients alike to know as much as possible about the odds of survival following treatment. 

The new technology from LUMA Vision allows operators to deliver 2D and 4D ultrasound images in real time. The advanced catheter was built with maneuverability and increased visibility in mind.