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Peripheral Intervention

JEVT publishes world’s first prospective, multicenter tibiopedal study


Patients suffering from critical limb ischemia (CLI) are often a difficult population to treat due to the likelihood of significant comorbidities including lesions that may be extremely difficult to cross. Increasingly, physicians are crossing these difficult lesions from a tibiopedal retrograde approach.

In order to determine the technical access and crossing success rate and safety of these procedures, Cook Medical sponsored the world’s first prospective, multicenter tibiopedal study.

In December, the Journal of Endovascular Therapy (JEVT) published results of the study titled “Tibiopedal Access for Crossing of Infrainguinal Artery Occlusions: A Prospective Multicenter Observational Study.”

According to Mark Breedlove, vice president and global business unit leader of Peripheral Intervention, “We wanted to learn more about new crossing procedures and techniques and find out what works and what does not,” he explained. “The study was designed to provide physicians with safety and technical success measures to potentially help expand their ability to safely treat these difficult lesions and patient population.”

Results of the study indicate that technical tibiopedal access success was achieved in 93.4% of 197 patients and technical occlusion crossing success in 85.3% of the 184 successful tibial accesses. The access success rate was 92.4% after a failed antegrade access vs. 95.4% in those with a primary tibiopedal attempt. Crossing success was achieved in 82.8% after a failed antegrade access vs. 90.3% for patients with no prior antegrade attempt.

The majority of the study participants (67.0%) had previously experienced a failed antegrade attempt to cross the occlusion. Of these patients, 77.3% had combined access and crossing success from a tibiopedal access.

Minor complications related to the access site occurred in 5.6% of cases. No patient had access vessel thrombosis, compartment syndrome, or surgical revascularization.

The study’s authors determined that “tibiopedal access appears to be safe and can be used effectively for the crossing of infrainguinal lesions in patients with severe lower limb ischemia.”

Results of the study show that high retrograde access and crossing success may have prevented amputations for those who had previously undergone a failed antegrade procedure.

Here is principal investigator Dr. Craig Walker talking about the study: