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Tibiopedal access route yields high access, crossing rates in infrainguinal CTO
Among patients with infrainguinal chronic total occlusions, retrograde crossing of occlusions using a tibiopedal access route appears to yield high access and lesion-crossing rates with few and minor access-related complications, according to recent findings.
In the prospective, nonrandomized, multicenter observational study, researchers evaluated 197 patients (mean age, 71 years; range, 41 to 93 years; 129 men) who were enrolled from eight U.S. and three European sites.
Eligible patients had an infrainguinal CTO that was treated with a percutaneous tibiopedial access after the failure of an antegrade approach or underwent tibiopedial access as a primary treatment at sites where tibiopedal access is standard of care. A failed antegrade approach was the initial treatment in 132 (7%) cases.
Claudication and CLI
The study population included 64 (32.5%) patients with claudication (Rutherford category 2 or 3) and 133 (67.5%) patients with critical limb ischemia (CLI; Rutherford category 4).
All devices and techniques were at the operator’s discretion.
The researchers collected the following data on all patients: demographic data and medical history, Rutherford classification, location of access vessel, lesion characteristics, treatments utilized and all procedure-related complications. Patients were followed at 30 days through a telephone call, during which any complications were documented and the postoperative Rutherford category was evaluated. Rutherford category was treated as a continuous variable for comparison with the population’s preoperative values. The investigators recorded all access site-related complications, minor events and major events. Amputations and adverse events associated with the development of new wounds in the study leg were documented.
ess, technical crossing success and treatment success after crossing.
chieved in 93.4% patients — 62 (96.9%) of the 64 claudicants and 122 (91.7%) of the 133 patients with CLI.
Women had a higher incidence of failed access attempts (9 of 13), although they comprised only one-third of the patient cohort. Women were more likely than men to have more severe calcification at the access site.
ssful tibiopedal access cases, 85.3% achieved technical retrograde crossing success; this included 52 (83.9%) of 62 claudicants and 105 (86.1%) of 122 patients with CLI. Men and women had approximately equivalent rates of successful crossing (84.7% in women vs. 85.6% in men).
Past attempts
There was no significant difference in technical success based on previous failed antegrade attempt; the access success rates were 92.4% after a failed antegrade access vs. 95.4% in patients for whom tibiopedal access was the primary approach (P = .55) Likewise, 82.8% of patients with a prior failed antegrade access achieved crossing success vs. 90.3% of patients without a previous failed attempt (P = .19).
The following minor access site-related complications were recorded postoperatively: local pain (2%), infection (1%), ecchymosis (1%), bleeding (1%) and acute vessel dissection (0.5%). No major access-related complications were seen. The following nonaccess-related adverse events were recorded: gangrene (3%), ischemia (4.1%) and ischemic ulcer (2.5%). Twelve patients (6.1%) required six major and six minor amputations.
“The study suggests increasing utilization of this approach as a primary treatment for CLI and as a treatment option for severe claudication,” the researchers wrote. “The rapid growth of the CLI population, combined with the morbidity and mortality associated with major limb amputation, emphasizes the critical need for additional research on the effectiveness of tibiopedal access and revascularization from a retrograde access site.” – by Jennifer Byrne
Disclosure: The study was funded by Cook Medical. Most of the researchers report financial ties with Cook Medical. Please see the full study for a list of all the researchers’ relevant financial disclosures.