May 17, 2025
A novel self-centering catheter designed to aid the retrograde crossing of a severely stenotic aortic valve (AV) during transcatheter aortic valve replacement (TAVR) procedures is safe and effective, according to new research.
"Mayo Clinic was first in the world to use this new TAVR catheter," says Mackram F. Eleid, M.D., an interventional cardiologist at Mayo Clinic in Rochester, Minnesota, and lead author of the study. The open-label, first-in-human early feasibility study was published in JACC: Cardiovascular Interventions.
Purpose-built TAVR catheter
This single-center study is the first to test a purpose-built catheter for retrograde AV crossing during TAVR procedures. The research included adults with severe symptomatic aortic stenosis (AS) undergoing transfemoral TAVR.
"This self-centering aortic valve crossing catheter was invented and designed at Mayo Clinic, and subsequent development and testing was done in collaboration with Boston Scientific," says Gurpreet S. Sandhu, M.D., Ph.D., the vice chair (International) of Cardiovascular Medicine at Mayo Clinic in Rochester, Minnesota, and senior author of the study. Dr. Sandhu is one of the inventors listed on the patent.
Despite advances in TAVR in the last two decades, retrograde crossing of the AV to place the guidewire for TAVR valve delivery continued to remain unchanged and challenging, with catheters designed for coronary angiography and guidewires being used to probe for the valve opening.
This self-centering catheter research is an example of how Mayo Clinic Cardiovascular Medicine specialists are improving patient safety by inventing treatment solutions that did not exist before. "Cardiologists have had to cross narrowed aortic valves against the direction of flow with wires and catheters for a variety of diagnostic and valve replacement procedures. This can sometimes be a time-consuming process and comes with a risk of damaging the valve or dislodging fragments from the valve or aorta that can go to the brain and cause a stroke," says Dr. Sandhu. "We were searching for solutions that would allow us to cross quickly and safely, thereby minimizing the procedural risk."
High velocity alignment
The novel device is designed to align itself with the high velocity AS blood flow stream and help direct a guidewire across the stenotic AV in patients during TAVR procedures. It has a self-centering basket comprising a cone-shaped nitinol frame with an expanded polytetrafluoroethylene covering and silicone coating.
"The catheter was safe and not associated with any adverse events in the 20 patients in whom it was used," says Dr. Eleid. "This research offers the potential to make the procedure safer and more efficient, ultimately benefiting patients and the healthcare system."
Using this catheter may reduce:
- Radiation exposure for both the patient and the procedural team.
- Risk of thromboemboli and strokes from repeatedly probing the valve during the current process of crossing.
- Duration a patient spends under moderate sedation or anesthesia.
Study details
The study included 20 patients with severe aortic stenosis. Nineteen patients had tricuspid AS and one had bicuspid AS.
The mean patient age was 78 years old, and 45% of patients were female. The mean Society of Thoracic Surgeons score was 7.2.
All patients underwent transfemoral TAVR — 18 patients received a balloon-expandable valve, and two received a self-expanding valve.
The TAVR procedures were all a success, and no adverse events were reported.
A guidewire was successfully delivered through the self-centering catheter across the AV into the left ventricle in 18 (90%) of 20 patients, and 18 (78.3%) of the 23 devices used.
The AV was crossed with a guidewire in three or fewer attempts 43.5% of the time, and the self-centering basket was successfully recaptured in all devices.
The average time from insertion of the catheter into the body to removal was 6.6 minutes.
Next steps
The research brings the potential to impact clinical care. "These findings demonstrate the safety of the device and show that it is efficacious for crossing the aortic valve. They're the basis for moving forward with further device development," says Dr. Eleid. "More refinements and an expanded early feasibility study are anticipated." Future device improvements may include enhanced steerability, ease of use and overall performance. Randomized studies comparing the self-centering catheter to existing catheters used in TAVR are needed.
Creating new problem-solving devices like the self-centering catheter exemplifies how Mayo Clinic cardiologists approach patient care. "Mayo Clinic Cardiology has a history of innovation dating back more than 100 years," says Dr. Sandhu. "This includes a spectrum of technologies designed to diagnose and treat a variety of heart conditions, and offer procedures, surgeries, medications and digital solutions to cure, connect and transform cardiac care worldwide."
For more information
Eleid MF, et al. A novel self-centering aortic valve crossing catheter for transcatheter aortic valve replacement. JACC: Cardiovascular Interventions. 2025;18:820.
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