Respuesta :
This study was to present a prospective, multicenter, observational study on the security and efficiency of tibiopedal access and retrograde crossing in the treatment of infrainguinal chronic complete occlusions (ClinicalTrials.gov identifier NCT01609621) (CTOs).
- From May 2012 to July 2013, 197 patients (mean age 7111 years, range 41-93; 129 men) who met the inclusion criterion of at least one CTO for which a retrograde crossing surgery was scheduled or became necessary were prospectively enrolled at 12 sites across the globe.
- The population was made up of 133 (67.5%) patients with critical limb ischemia and 64 (32.5%) claudicants (Rutherford classifications 2/3).
- In 132 (67.0%) cases, an initial antegrade attempt to cross had been made before the tibiopedal attempt.
- The operator chose the access, crossing of the retrograde lesion, and treatment methods.
- Following the procedure, 30 days of follow-up data were collected.
What were the results observed?
- Of the 197 patients, 184 (93.4%) had successful technical tibiopedal accesses, while 157 (85.3%) had successful technical occlusion crossings.
- There were more unsuccessful access attempts among women (9 of 13 failures).
- Between the sexes, the rate of successful crossing was almost equal (84.7% (50/59) for women and 85.6% (107/125) for males).
- The success rate of the access was 92.4% (122/132) following a failed antegrade access attempt compared to 95.4% (62/65) in individuals who had made a primary tibiopedal attempt (p=0.55).
- Technical success did not differ substantially dependent on a prior unsuccessful antegrade attempt.
- Similarly, 82.8% (101/122) of patients with failed antegrade access succeeded in crossing, compared to 90.3% (56/62) of patients who had never attempted antegrade access (p=0.19).
- 11 (5.6%) incidences of minor access site problems occurred; no patient experienced access vessel thrombosis, compartment syndrome, or surgical revascularization.
Conclusion of the observational study:
- In patients with severe lower limb ischemia, tibiopedal access appears to be safe and can be utilized successfully to cross infrainguinal lesions.
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