Abstract: Background. There is increasing burden of peripheral arterial disease (PAD) in the United States. Despite advancements in endovascular therapy, there have been significant limitations in invasive interventions aimed at revascularization. The transpedal tibial artery retrograde approach has been described as an alternative access for patients with complex disease requiring dual access or failed revascularization via conventional common femoral artery access. In this study, we examined the safety and efficacy of a radial hemostatic band to achieve hemostasis post procedure without compromising the integrity of the accessed tibial artery. Methods. This study included 20 patients with PAD requiring endovascular revascularization on whom the RadAR band device (Advanced Vascular Dynamics) was applied for postprocedure hemostasis following transpedal access between December 2011 and May 2014. All patients underwent routine postprocedure ankle-brachial indices (ABIs) following hemostasis to determine outcomes of the overall ABI and that of the accessed pedal artery. Results. Mean patient age was 77 years and mean patient weight was 80.9 kg. Mean follow-up was 11 months post procedure. Lesions were located as follows: 3 popliteal, 13 superficial femoral, 3 posterior tibial, and 1 anterior tibial. Nine procedures were performed on the left leg and 11 on the right leg. All patients received heparin as anticoagulation, with a targeted activated clotting time between 250-300 seconds. Access was made into the posterior tibial in 15 patients and in the anterior tibial in 5 patients. RadAR band was deployed in a fashion similar to its deployment on the radial artery. Hemostasis was achieved in all 20 cases without complication. Postprocedure ABI and pedal-brachial index (PBI) improved significantly compared with the preprocedure values. There was an average improvement of approximately 50% in ABIs, improving from 0.59 to 0.88. The PBI also improved from 0.59 before the procedure to 0.87 post procedure. There was, however, no significant difference in ABI or PBI in anterior vs posterior tibial artery access patients. Conclusion. Transpedal tibial arterial access is an effective technique for revascularization in the lower extremity, and postprocedure access-vessel hemostasis and patency are reliably and safely achieved using a hemostatic band device.
J INVASIVE CARDIOL 2020;32(1):1-4.
Key words: anticoagulation, hemostasis, tibial access
Peripheral arterial disease (PAD), which comprises atherosclerotic obstruction of the arteries of the lower extremities, involves a wide range of disorders of the structure and function of all non-coronary arteries.1 PAD and its sequelae often affect productivity and quality of life, with increased cardiovascular morbidity and mortality.2,3 Globally, there is increasing burden of PAD, with an estimated 200 million individuals with the disease.4 There is increasing prevalence of PAD in the United States, largely driven by the rising epidemic of obesity. Currently, PAD is estimated to affect between 15%-20% of individuals >70 years old.5
Despite the advancements in endovascular therapy in the management of PAD, there are still several limitations, which include: lack of adequate access; radiation exposure; excessive bleeding; and contrast-induced nephropathy due to heavy dye loads during long procedures.6,7 To circumvent some of these complications, interventionalists have utilized alternative access strategies such as transpedal tibial artery access, which is a technique used for patients with complex disease requiring dual access or for those who have failed revascularization via conventional common femoral artery access.8 In these cases, securing hemostasis post procedure without compromising tibial vessel patency can pose a challenge. While the use of radial hemostatic bands post transradial artery access has been shown to achieve hemostasis post procedure without neurovascular complications, their use following transpedal tibial artery access has not been widely established. In this study, we examined the safety and efficacy of the RadAR radial hemostatic band (Advanced Vascular Dynamics) to obtain hemostasis post transpedal tibial artery access.
This single-center study included PAD patients who underwent endovascular revascularization procedures from December 2011 to May 2014 requiring transpedal tibial artery access followed by postprocedure hemostasis utilizing a radial hemostatic band. A single transpedal tibial artery was accessed using the micropuncture kit followed by placement of a transpedal microsheath. After access was obtained, all patients received intra-arterial vasodilators as well as anticoagulation with heparin for a targeted activated clotting time between 250-300 seconds. Nine procedures were performed on the left leg and 11 were performed on the right leg. Access was obtained in the posterior tibial artery in 15 patients and the anterior tibial artery in 5 patients. All patients had successful revascularization of the target lesion utilizing transpedal tibial artery access. Upon completion of the procedure, the RadAR band was applied to the accessed tibial artery in a fashion similar to its deployment on the radial artery (Figure 1). The physician applied the RadAR band, and postprocedure care for stepwise removal was provided by recovery area nursing staff. Compression times were maintained per protocol by the nursing staff regularly checking the extremity during the hemostasis period to ensure patency by palpating pulses as well as visual assessment of the accessed lower extremity (Table 2). Hemostasis was achieved in all cases without complication. Postprocedure ankle-brachial index (ABI) and pedal-brachial index (PBI) for the accessed tibial artery were collected. The ABI was used to assess procedural success. The PBI was used to assess patency of the access vessel, as it allowed the assessment of flow into the accessed tibial vessel.
The data from a total of 20 patients were reviewed (Table 1). Mean patient age was 77 years and mean weight was 80.9 kg. The index PAD lesions were localized in the following vessels: 3 in the popliteal, 13 in the superficial femoral, 3 in the posterior tibial, and 1 in the anterior tibial artery. Transpedal tibial artery access was made into the posterior tibial in 15 patients and into the anterior tibial in 5 patients. Hemostasis was achieved in all 20 cases without complication.
Postprocedure ABI in the target extremity improved over the preprocedure ABI for all patients during a follow-up period of 11 months (Figure 2). The average improvement was approximately 50%, with ABI improving from 0.59 to 0.88. Likewise, PBI improved in all patients, from an average of 0.59 before the procedure to 0.87 after the procedure, or approximately 61%. There was no significant difference in the changes in ABI or PBI in the anterior tibial access patients compared with the posterior tibial artery access patients.
In this small, single-center study, we demonstrated that transpedal tibial artery access is an effective technique for revascularization in the lower extremity, and postprocedure access-vessel hemostasis and patency are reliably and safely achieved using a radial hemostatic band device.
Due to the substantial comorbidities associated with PAD and critical limb ischemia, endovascular approaches to revascularization have become the primary modes of therapy in most instances. With the increase in percutaneous interventions of lower extremities for complex PAD, transpedal tibial artery access has become a favorable alternative access option for revascularization.
Prior studies have demonstrated the benefits of a transpedal tibial artery access strategy, including decreased radiation exposure, quicker recovery time, and a lower risk of complications.8 In an original case series, Mustapha et al demonstrated that retrograde tibiopedal intervention was safe and effective. They also showed that the transpedal tibial artery access technique offers an alternate revascularization method for critically ill advanced PAD patients.8 It was shown to allow operators to selectively engage the target tibial vessel and revascularize retrogradely from the tibial access, avoiding the complications encountered with an antegrade approach from the ipsilateral or contralateral common femoral artery.
Vascular band use for transradial arterial access has been established as a common tool in achieving hemostasis by mechanical compression to the accessed artery post intervention.9 Achieving hemostasis at the access site is a critical component of a successful endovascular intervention.9-11 In current management, manual compression of the radial artery after transradial access has been replaced by mechanical compression devices due to the length of compression time needed to achieve hemostasis with current antiplatelet and anticoagulant therapies.11 These mechanical compression devices have been widely accepted in clinical practice, with excellent outcomes.
In our study, we demonstrated that a radial hemostatic band can be used as a tool to achieve hemostasis after a transpedal tibial artery revascularization approach to treat PAD. To our knowledge, this is the first study that has systematically demonstrated the efficacy and safety of the radial hemostatic band to achieve access-site hemostasis after a transpedal tibial artery access procedure.
Study limitations. Our study is limited by the small sample size and single-center design.
The consistent, significant improvements in the ABI and PBI in this study demonstrate that transpedal tibial artery access is an effective approach for revascularization in the lower extremity, and that postprocedure access-vessel hemostasis and patency are reliably and safely achieved when using a radial hemostatic compression device for postprocedure hemostasis.
From the Division of Cardiology, Heart and Vascular institute, Einstein Medical Center, Philadelphia, Pennsylvania.
Disclosure: The authors have completed and returned the ICMJE Form for Disclosure of Potential Conflicts of Interest. The authors report no conflicts of interest regarding the content herein.
Manuscript submitted June 17, 2019, provisional acceptance given July 30, 2019, final version accepted August 14, 2019.
Address for correspondence: Jon C. George, MD, MD, Division of Interventional Cardiology, Cardiology Department, Albert Einstein Medical Center, Philadelphia, PA 19141. Email: email@example.com
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- Chatelain P, Arceo A, Rombaut E, Verin V, Urban P. New device for compression of the radial artery after diagnostic and interventional cardiac procedures. Cathet Cardiovasc Diagn. 1997;40:297-300.
- Ochiai M, Sakai H, Takeshita S, et al. Efficacy of a new hemostatic device, adapty, after transradial coronary angiography and intervention. J Invasive Cardiol. 2000;12:618-622.
- Pancholy SB. Impact of two different hemostatic devices on radial artery outcomes after transradial catheterization. J Invasive Cardiol. 2009;21:101-104.