Dataset Information

Tibiopedal Access for Crossing of Infrainguinal Artery Occlusions: A Prospective Multicenter Observational Study.

ABSTRACT: PURPOSE:To report a prospective, multicenter, observational study (ClinicalTrials.gov identifier NCT01609621) of the safety and effectiveness of tibiopedal access and retrograde crossing in the treatment of infrainguinal chronic total occlusions (CTOs). METHODS:Twelve sites around the world prospectively enrolled 197 patients (mean age 71±11 years, range 41-93; 129 men) from May 2012 to July 2013 who met the inclusion criterion of at least one CTO for which a retrograde crossing procedure was planned or became necessary. The population consisted of 64 (32.5%) claudicants (Rutherford categories 2/3) and 133 (67.5%) patients with critical limb ischemia (Rutherford category ?4). A primary antegrade attempt to cross had been made prior to the tibiopedal attempt in 132 (67.0%) cases. Techniques used for access, retrograde lesion crossing, and treatment were at the operator's discretion. Follow-up data were obtained 30 days after the procedure. RESULTS:Technical tibiopedal access success was achieved in 184 (93.4%) of 197 patients and technical occlusion crossing success in 157 (85.3%) of the 184 successful tibial accesses. Failed access attempts were more common in women (9 of 13 failures). The rate of successful crossing was roughly equivalent between sexes [84.7% (50/59) women compared to 85.6% (107/125) men]. Technical success did not differ significantly based on a prior failed antegrade attempt: the access success rate was 92.4% (122/132) after a failed antegrade access vs 95.4% (62/65) in those with a primary tibiopedal attempt (p=0.55). Similarly, crossing success was achieved in 82.8% (101/122) after a failed antegrade access vs 90.3% (56/62) for patients with no prior antegrade attempt (p=0.19). Minor complications related to the access site occurred in 11 (5.6%) cases; no patient had access vessel thrombosis, compartment syndrome, or surgical revascularization. CONCLUSION:Tibiopedal access appears to be safe and can be used effectively for the crossing of infrainguinal lesions in patients with severe lower limb ischemia.

SUBMITTER: Walker CM

PROVIDER: S-EPMC5315197 | biostudies-literature | 2016 Dec

REPOSITORIES: biostudies-literature

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Tibiopedal Access for Crossing of Infrainguinal Artery Occlusions: A Prospective Multicenter Observational Study.

Walker Craig M CM Mustapha Jihad J Zeller Thomas T Schmidt Andrej A Montero-Baker Miguel M Nanjundappa Aravinda A Manzi Marco M Palena Luis Mariano LM Bernardo Nelson N Khatib Yazan Y Beasley Robert R Leon Luis L Saab Fadi A FA Shields Adam R AR Adams George L GL

Journal of endovascular therapy : an official journal of the International Society of Endovascular Specialists 20160824 6

<h4>Purpose</h4>To report a prospective, multicenter, observational study (ClinicalTrials.gov identifier NCT01609621) of the safety and effectiveness of tibiopedal access and retrograde crossing in the treatment of infrainguinal chronic total occlusions (CTOs).<h4>Methods</h4>Twelve sites around the world prospectively enrolled 197 patients (mean age 71±11 years, range 41-93; 129 men) from May 2012 to July 2013 who met the inclusion criterion of at least one CTO for which a retrograde crossing p ...[more]

PMID: 27558463

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Project description:Objective:Infra-pyloric artery (IPA) is an important anatomical landmark in treatment of gastric cancer and is the key vessel for pylorus-preserving gastrectomy and subgroup of infra-pyloric lymph nodes. However, its anatomical variation is not thoroughly understood. Our study aimed to clarify the origination of the IPA. Methods:We did this prospective, multicenter, open-label, observational study at gastric surgery departments of 34 hospitals in China. Gastric cancer patients aged 18 years or older and scheduled to undergo elective total or distal gastrectomy were assigned. During the surgery, IPA dissecting and exposing the origination point with photographs or video clips were required. The primary outcome was the origination of the IPA. Analysis of variance, ?2 tests and Fisher's tests were used to analyze the differences between groups. The study is registered at Clinicaltrials.gov (No. NCT03071237). Results:Between May 8 and July 31, 2017, 429 patients were assigned for the study, and 419 (97.7%) patients had the IPA dissected and recorded through photograph or video and were included in the primary outcome analysis. The median age was 62 years old, and 73.7% were male. Among the patients, 78.5% received laparoscopic surgery. Single IPA origination was identified in 398 (95.0%) patients, including gastroduodenal artery (GDA) in 154 (36.8%) patients, anterior superior pancreaticoduodenal artery (ASPDA) in 130 (31.0%) patients, and right gastroepiploic artery (RGEA) in 114 (27.2%) patients. Fifteen (3.6%) patients were identified with multiple IPA and 6 (1.4%) patients were identified as IPA absence. The differences in the distribution of surgical approach (P=0.003) and geographic area (P=0.030) were statistically significant. No difference was shown in sex, age, gastrectomy type, tumor location, and clinical T, N and M stage. Conclusions:Our study found that the IPA originates from GDA, ASPDA and RGEA in similar proportions. Laparoscopic surgery may be more helpful in dissection of the IPA than open surgery.

Project description:BackgroundRadial access (RA) may offer advantages in peripheral interventions, but previous studies on this approach have been limited to retrospective or single-center studies. Our aim was to prospectively evaluate the safety and feasibility of RA for complex endovascular lower extremity interventions.MethodsIn this prospective, multicenter, and observational study, eligible patients with peripheral artery disease scheduled for intervention through RA were enrolled. Primary efficacy end point was procedural success, defined as successful completion of the intended procedure without conversion to femoral access and without RA complications periprocedure. Primary safety end point included evaluation of RA-related complications at 30 days.ResultsFrom June 2020 to June 2021, 120 patients at 8 US centers were enrolled. Mean age was 68.7 years, and 31.7% were women. The 224 lesions treated were in iliac (12.9%), femoropopliteal (55.3%), isolated popliteal (11.9%), and tibial (19.5%) vessels. The primary efficacy end point was achieved in 112 (93.3%) patients. One patient (<1%) required femoral access conversion to complete the procedure. Thirty (25.0%) patients required 1 or more additional access to facilitate crossing and/or to complete the planned treatment (5 femoral, 10 tibial, and 17 pedal accesses). No serious adverse events were adjudicated to the procedure. Mean procedure time and time to ambulation was 74 minutes and 3 hours 30 minutes; respectively, with 93.3% same-day discharge. At 30 days, 97.2% of patients recorded ultrasound-confirmed RA patency.ConclusionsThis is the first prospective and multicenter registry to show the safety and efficacy of RA approach for complex endovascular lesions and multilevel disease. RA allowed early ambulation and same-day discharge with no serious adverse events. Future randomized trials should examine the clinical and cost effectiveness of this approach compared with those of femoral access for patients with peripheral artery disease.

Dataset Information

Tibiopedal Access for Crossing of Infrainguinal Artery Occlusions: A Prospective Multicenter Observational Study.

Publications

Tibiopedal Access for Crossing of Infrainguinal Artery Occlusions: A Prospective Multicenter Observational Study.

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