Teleflex has announced that Magnus Settergren, associate professor at the Karolinska Institutet, interventional cardiologist at Karolinska University Hospital (Stockholm, Sweden), and co-author of the Percutaneous plug-based vascular closure device in 1,000 consecutive transfemoral transcatheter aortic valve implantations study, is scheduled to present at a Teleflex-sponsored training pavilion on Sunday 18 September at 10am (ET) at the Transcatheter Cardiovascular Therapeutics (TCT) 2022 meeting (16–19 September 2022; Boston, USA).
The Karolinska 1,000 consecutive MANTA device study—the largest ever real-world evaluation of the Manta device—demonstrated safety and effectiveness with low complication rates and a short learning curve. Results of the study were published in The International Journal of Cardiology.
The single-centre, observational study reviewed 1,048 consecutive, unselected subjects undergoing transfemoral transcatheter aortic valve implantation (TAVI) from May 2017 to September 2020 at the Karolinska University Hospital. The 18 French MANTA device was used by five operators to close the femoral artery access site in 1,000 subjects (48 excluded), with the primary outcome being the measure of vascular closure device (VCD)-related major complications according to Valve Academic Research Consortium (VARC)-2 definition criteria.
The study demonstrated that Manta device-related major vascular complications occurred in 4.2% of patients with no significant differences in preoperative characteristics between patients with and without Manta device-related major vascular complication.
This outcome is consistent with the results of the SAFE MANTA investigational device exemption clinical trial, published in 2019 in Circulation: Cardiovascular Interventions, which demonstrated a 4.2% VARC-2 major vascular complication rate, as well as The MARVEL prospective registry, published in 2020 in Catheterization & Cardiovascular Interventions, which demonstrated a 4% VARC-2 major vascular complication rate.
“As interventionalists, we frequently hear that one of the argued benefits of the MANTA device compared to suture-based VCDs is a comparatively shorter learning curve; however, few studies have included a learning curve analysis,” said Settergren. “Our study found no significant differences in major complications between interventionalists, whether in their first 20 MANTA device deployments, or even across the first 100 procedures at the centre.
“The findings of our study indicate that the MANTA device is easy to learn and has a short learning curve, which is in line with our user experience. I look forward to presenting our learnings from this real-world experience to my colleagues at TCT this weekend,” he added.