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

Craig M Walker, Jihad Mustapha, Thomas Zeller, Andrej Schmidt, Miguel Montero-Baker, Aravinda Nanjundappa, Marco Manzi, Luis Mariano Palena, Nelson Bernardo, Yazan Khatib, Robert Beasley, Luis Leon, Fadi A Saab, Adam R Shields, George L Adams, Craig M Walker, Jihad Mustapha, Thomas Zeller, Andrej Schmidt, Miguel Montero-Baker, Aravinda Nanjundappa, Marco Manzi, Luis Mariano Palena, Nelson Bernardo, Yazan Khatib, Robert Beasley, Luis Leon, Fadi A Saab, Adam R Shields, George L Adams

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.

Keywords: chronic total occlusion; critical limb ischemia; peripheral artery disease; retrograde approach; tibiopedal; transpedal; vascular access.

Conflict of interest statement

Declaration of Conflicting Interests: The author(s) declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: Craig Walker is a consultant and speaker for Cook Medical. Jihad Mustapha is a consultant for Cook Medical. Thomas Zeller has received study grants and speaking honoraria from Cook Medical. Andrej Schmidt is a consultant for Cook Medical. Miguel Montero-Baker is a speaker for Cook Medical. Aravinda Nanjundappa is a consultant for Cook Medical and a speaker for Jannsenn Pharmaceuticals, Astra Zeneca, and Pfizer. Marco Manzi and Mariano Palena are speakers and consultants for Cook Medical. Nelson Bernardo conducts training courses for Cook Medical. Yazan Khatib is a consultant for Cook Medical and is a board member for Bayer and Boston Scientific. Robert Beasley performs training for Abbott Vascular, Bard, BSCI, Cook Medical, Cordis, Medtronic/Covidien, CSI, Endologix, Gore, Lombard Medical, and Spectranetics. Fadi Saab is a consultant for Cook Medical. Adam Shields is a paid employee of MED Institute, Inc, a contract research organization and a Cook Group company. George Adams is a consultant and speaker for Cook Medical.

© The Author(s) 2016.

Figures

Figure 1.
Figure 1.
(A) Comparison of the mean preoperative and 30-day Rutherford category values. (B) The top matrix exhibits the percentage of patients that moved between specific Rutherford categories. The matrix diagonal represents patients with no change in score; to the left and right of the diagonal are improved and worsened levels, respectively. The bottom bar graph is the summed percentage of patients from the matrix who had a change in Rutherford category of a given magnitude.

References

    1. Iyer SS, Dorros G, Zaitoun R, et al. Retrograde recanalization of an occluded posterior tibial artery by using a posterior tibial cutdown: two case reports. Cathet Cardiovasc Diag. 1990;20:251–253.
    1. Allie DE, Hebert CJ, Walker CM, et al. Critical limb ischemia: a global epidemic. A critical analysis of current treatment unmasks the clinical and economic costs of CLI. EuroIntervention. 2005;1:75–84.
    1. Norgren L, Hiatt WR, Dormandy JA, et al. Inter-society consensus for the management of peripheral arterial disease (TASC II). J Vasc Surg. 2007;45(suppl S):S5–S67.
    1. Montero-Baker M, Schmidt A, Bräunlich S, et al. Retrograde approach for complex popliteal and tibioperoneal occlusions. J Endovasc Ther. 2008;15:594–604.
    1. Rogers RK, Dattilo PB, Garcia JA, et al. Retrograde approach to recanalization of complex tibial disease. Catheter Cardiovasc Interv. 2011;77:915–925.
    1. Botti CF, Jr, Ansel GM, Silver MJ, et al. Percutaneous retrograde tibial access in limb salvage. J Endovasc Ther. 2003;10:614–618.
    1. Bazan HA, Le L, Donovan M, et al. Retrograde pedal access for patients with critical limb ischemia. J Vasc Surg. 2014;60:375–381.
    1. Mustapha JA, Saab F, McGoff T, et al. TAMI technique: tibiopedal arterial minimally invasive retrograde revascularization. Endovascular Today. 2013;1:39–47.
    1. Fusaro M, Tashani A, Mollichelli N, et al. Retrograde pedal artery access for below-the-knee percutaneous revascularization. J Cardiovasc Med. 2007;8:216–218.
    1. Downer J, Uberoi R. Percutaneous retrograde tibial access in the endovascular treatment of acute limb ischaemia: a case report. Eur J Vasc Endovasc Surg. 2007;34:350–352.
    1. Kawarada O, Yokoi Y, Sekii H, et al. Retrograde crossing through the pedal arch for totally occluded tibial artery. J Interv Cardiol. 2008;21:342–346.
    1. Hansen A, Krawzcynski H, Lacher F. Retrograde transpedal recanalization of tibial artery occlusion. Vasa. 2009;38:249–253.
    1. Gür S, Oğuzkurt L, Gürel K, et al. US-guided retrograde tibial artery puncture for recanalization of complex infrainguinal arterial occlusions. Diagn Interv Radiol. 2013;19:134–140.
    1. Walker C. Pedal access in critical limb ischemia. J Cardiovasc Surg (Torino). 2014;55:225–227.
    1. Walker CM. Pedal access in critical limb ischemia. In: Dieter RS, Dieter RA, Dieter RA, III, eds. Endovascular Interventions. New York, NY: Springer; 2014:805-822.
    1. Montero-Baker M. The retrograde approach for BTK chronic total occlusions. Endovascular Today. 2014;5:55-64.
    1. El-Sayed HF. Retrograde pedal/tibial artery access for treatment of infragenicular arterial occlusive disease. Methodist Debakey Cardiovasc J. 2013;9:73–78.
    1. Mustapha JA, Saab F, McGoff T, et al. Tibio-pedal arterial minimally invasive retrograde revascularization in patients with advanced peripheral vascular disease: the TAMI technique, original case series. Catheter Cardiovasc Interv. 2014;83:987–994.
    1. Hanna EB, Prout DL. Combined radial-pedal access strategy and radial-pedal rendezvous in the revascularization of complex total occlusions of the superficial femoral artery (the “no femoral access” strategy). J Endovasc Ther. 2016;23:321–329.
    1. Dietrich CF, Horn R, Morf S, et al. US-guided peripheral vascular interventions, comments on the EFSUMB guidelines. Med Ultrason. 2016;18:231–239.
    1. Kalish J, Eslami M, Gillespie D, et al. ; Vascular Study Group of New England. Routine use of ultrasound guidance in femoral arterial access for peripheral vascular intervention decreases groin hematoma rates. J Vasc Surg. 2015;61:1231–1238.
    1. Lo RC, Fokkema MT, Curran T, et al. Routine use of ultrasound-guided access reduces access site-related complications after lower extremity percutaneous revascularization. J Vasc Surg. 2015;61:405–412.
    1. Hoffman U, Schulte KL, Heidrich H, et al. Complete ulcer healing as primary endpoint in studies on critical limb ischemia? A critical reappraisal. Eur J Vasc Endovasc Surg. 2007;33:311–316.

Source: PubMed

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