Closure Devices for Groin and Tibial Access: The Value of Dual Access in CLI Therapy

J.A. Mustapha, MD
Many of the trials evaluating closure devices with manual compression have shown no significant value or advantages to closure devices, except for minimizing the time to ambulate and possibly early discharge. The question remaining to be answered is whether the value of ultrasound-guided access followed by ultrasound-guided closure device placement could have the potential of being superior to manual compression, due to the fact that the operator can visualize device placement, deployment, and immediate evaluation of the result post deployment. Ultrasound-guided access with use of closure devices has been shown to be associated with a low complication rate.¹ 

 

It is time for us to start using a superior technical approach by adding ultrasound to groin access, whether retrograde or antegrade, simply due to the fact that operators can visualize a segment. This can ensure an exit strategy can be safely closed or manually compressed before first stick.

 

 

Mark L. Lessne, MD: Ultrasound is the critical tool for all my vascular access, from radial to femoral to pedal. For antegrade femoral access, even my initial stick with the 25g lidocaine needle is sonographically guided to ensure appropriate access angle and allow deposition of the anesthetic directly adjacent to the nerve-containing adventia. For antegrade groin access, I use a longitudinal sonographic view to visualize the common femoral artery (CFA) bifurcation, superficial femoral artery (SFA), and profunda femoral artery (PFA) and subjacent femoral head in a single image. This permits single-wall entry with a micro puncture needle into the artery and manipulation of the microwire into the SFA entirely under ultrasound control, avoiding radiation exposure to the operator’s hand. Once I visualize the wire in the SFA by ultrasound, I exchange for the .035-inch Bentson wire (Cook Medical) and place the procedure sheath — usually 5 or 6 French (F). The entire access can be performed without any radiation. 

 

 

Dr. Lessne: Difficulty with antegrade femoral access often occurs in patients with large body habitus, which can lead to sheath kinking. This is especially true if thin-walled, radial Terumo Glidesheath Slender sheaths are used femorally, which I avoid in larger patients. Use of braided sheaths can be helpful to prevent kinking. Appropriate cranial fixation of the patient’s panniculus can mitigate many of these challenges. Additionally, our experience has shown that alternative access sites, including proximal SFA or pedal arteries, may be preferable in patients with habitus or anatomy posing difficulty for traditional antegrade CFA access. No doubt radial access will become increasingly important in these circumstances as manufacturers develop longer devices to reach peripheral lesions.  

 

 

Dr. Lessne: This has not been my experience, though I can only speak to ultrasound-guided access. In well-trained hands, sonographically guided access essentially eliminates the risk for PFA injury. I have certainly seen inadvertent PFA sticks, but these are exclusively from retrograde access and always by practioners untrained in or unwilling to use ultrasound guidance.  

 

 

Dr. Lessne: The loss of mechanical advantage with up-and-over access has been greatly mitigated by long, braided sheaths, often placed in coaxial fashion. However, I do not believe sheath technology has entirely eliminated this disadvantage compared to straight-line antegrade access. Device pushability and wire torquability are improved with antegrade access, and this benefit is magnified in the setting of CTOs and distal tibial or below-ankle interventions. Occasionally, I will encounter patients too tall to treat from a contralateral access and it is best to figure this out quickly and convert to antegrade access before spending significant procedure time. Finally, when groin and pedal access are required, the positive ergonomics of a single side setup for the interventional suite cannot be understated. 

 

 

Dr. Lessne: As I mentioned, the use of ultrasound greatly decreases radiation exposure during access, regardless of antegrade or retrograde technique. However, contralateral groin access requires radiation to advance over the bifurcation: this is eliminated with antegrade access. 

 

 

Dr. Lessne: The decision to abandon the initial approach is usually among the most difficult to make: we have all had cases when we have been rewarded after failing to cross a CTO and then “one more try” gets the job done. However, I think more often than not, having pre-planned criteria for switching to retrograde access is important; for me, I will often use a wire count (no more than 3 types) or fluoro time (<10 min) before obtaining retrograde access. I have found it psychologically essential to have the foot or leg prepped for retrograde access before the procedure begins: this eliminates the inertia to press on antegrade rather than halting the procedure, prepping and draping the foot — if the foot is already prepped, we move to it as effortlessly as we would a new wire. With regard to selecting a retrograde access site, I do believe in the benefits of angiosome-directed revascularization when possible, so the ulcer site usually dictates the artery to be accessed. If appropriate, my preference is to access arteries in Zone 1 or 2, mid to distal tibial and pedal arteries: at these levels, the arteries are easily visualized by ultrasound, and the distal vessels are superficial and well compressed against the bone. 

 

 

Dr. Lessne: I use closure devices for nearly all antegrade access and with a very high success rate. I use the Mynx Vascular Closure device (Cardinal Health) that uses an extravascular, non-thrombogenic polyethylene glycol sealant that dissolves in about 30 days. Occasionally, calcified plaque may rupture the balloon, but since this balloon can be visualized under ultrasound or — if inflated with contrast — under fluoroscopy, this can often be avoided. That said, other closure devices are likely as effective; I think operator experience and comfort are among the most important determinants of closure success.  

 

Dr. Mark Lessne can be contacted at mark.lessne@charlotteradiology.com

Disclosure: Dr. Lessne reports no conflicts of interest regarding the content herein.

Case Presentation
Mark L. Lessne, MD

A 73-year-old man with diabetes mellitus type II originally presented with a right, 2nd toe ulceration with underlying osteomyelitis. He was treated with right popliteal and tibioperoneal trunk intervention with subsequent healing. He later represented with a non-healing right ischemic heel ulcer despite conservative therapy.   

Hindfoot angiosomal revascularization was planned to optimize limb salvage. With palpable femoral pulses and no evidence of significant aortoiliac disease, an anterograde right common femoral artery (CFA) approach was chosen in anticipation of tibiopedal revascularization. 

The right CFA was accessed in longitudinal view under ultrasound guidance and a 6 French (F), 25 cm sheath was placed. Initial arteriogram showed a diseased but patent popliteal artery and tibioperitoneal trunk (Figure 1A). The peroneal artery was continuously patent, yielding a calcaneal branch, but the posterior tibial artery was occluded throughout the entirety of its course (Figure 1B). The common plantar artery was occluded and the lateral plantar artery opacified retrograde towards the inferior calcaneal cortex on lateral view from a patent anterior circulation and dorsal pedal loop. 

The patient was heparinized to a target activated clotting time (ACT) greater than 250. Antegrade recanalization of the posterior tibial artery was attempted with telescoping 2.3 F and 4.0 F Cook CXI support catheters over multiple .014-inch wires, but distal true lumen re-entry was ultimately unsuccessful (Figure 2). 

Therefore, the decision was made to attempt posterior tibial recanalization from a retrograde, pedal loop approach. The coaxial support catheters were advanced into the anterior tibial artery and an .014-inch hydrophilic wire was negotiated across the pedal loop and into the lateral plantar artery. From this approach, the common plantar and posterior tibial artery occlusions were successfully traversed in retrograde fashion (Figure 3). The lateral plantar and distal posterior tibial arteries were dilated with a 2 mm Bard Ultraverse balloon. Following balloon angioplasty of the posterior tibial tract, an .014-inch hydrophilic wire easily passed antegrade into the posterior tibial and lateral plantar arteries, providing a straighter vector for catheter exchange. 

Given significant calcification involving the posterior tibial segment, orbital atherectomy was performed with the 1.25 mm CSI micro crown across the posterior tibial and lateral plantar arteries. Following atherectomy, the lateral plantar artery and distal posterior tibial segment were then further dilated to 2.5 mm. The proximal and mid posterior tibial artery were further dilated to 3.5 mm caliber. The tibioperoneal trunk and most proximal posterior tibial artery were then dilated to 4.0 mm with a Bard Lutonix drug-coated balloon. Completion arteriogram confirmed expeditious flow through newly patent PTA and plantar artery with restoration of 3-vessel runoff to the foot (Figure 4). 

The patient was continued on aspirin and clopidogrel, and placed on clinic surveillance every 6 weeks in addition to routine wound care and ulcer offloading. At 1 month post procedure, there was new development of good quality granulation tissue with progressive diminution of ulcer size.