End-stage foot occurs in about 1 in 5 patients with critical limb threatening ischemia. Percutaneous deep vein arterialization has recently emerged as an option for revascularization in these otherwise no-option CLTI patients. There is no data on optimal management when DVA fails and current options are limited to fibrinolytics to reattempt DVA recanalization versus native vessel intervention to prevent foot amputation. Here we present a 62-year-old male patient who had a prior left below knee amputation, an occluded right posterior tibial DVA for prior limb salvage attempt, and contraindications to fibrinolytics who presented with new ischemic rest pain and active wounds of his right foot. He underwent a successful laser atherectomy-facilitated percutaneous balloon angioplasty of the right anterior tibial and dorsal pedis arteries achieving resolution of his rest pain and wound healing.
VASCULAR DISEASE MANAGEMENT 2020;17(12):E227-E230.
Key words: critical limb threatening ischemia, end-stage foot, percutaneous deep vein arterialization, laser atherectomy
Abbreviations: Critical limb threatening ischemia (CLTI), percutaneous deep vein arterialization (pDVA), arteriovenous fistula (AV fistula), cerebrovascular accident (CVA), percutaneous transluminal angioplasty (PTA), clinically driven target lesion revascularization (CD-TLR), drug-coated balloon (DCB)
Desert foot or end-stage foot comprises up to 20% of critical limb threatening ischemia (CLTI) patients, and is characterized by occlusions of the foot arteries including the dorsal pedis, lateral tarsal artery, both plantar arteries, and the plantar arch.1 Patients with end-stage foot are commonly diabetic and/or have advanced chronic kidney disease. These patients are at very high risk for major amputation and generally are poor candidates for surgical revascularization due to poor target vessels in the foot. Consequently, novel techniques such as percutaneous deep vein arterialization (pDVA) are emerging as last resort endovascular limb saving therapies for cases that otherwise would be destined for limb amputation.
A 62-year-old African American man who presented to us with true ischemic rest pain and ischemic active wounds involving his 2nd, 3rd, 4th, and 5th toes of his right foot as well as a 3 cm wound on his right heel (Rutherford 6). He had undergone a prior limb salvage attempt with a right posterior tibial DVA that occluded after he discontinued his antiplatelets and anticoagulation due to deep concerns of bleeding. The patient was a Jehovah’s witness with anemia and a prior episode of gastrointestinal bleed. He refused transfusion of blood products and declined lytic therapy to treat the occlusion of his DVA that had been performed 8 months earlier for a right heel wound. This wound had remained stable for several months with only a residual eschar. His medical history was relevant for gangrene of the left foot that was followed by left below knee amputation 20 months prior to this current presentation, ESRD on hemodialysis via a left arm AV fistula, secondary hyperparathyroidism, calciphylaxis, remote CVA with no residual neurological deficits and paroxysmal atrial fibrillation. Following his DVA which achieved excellent flow to his right foot, he was managed medically with triple therapy with aspirin, clopidogrel, and Apixaban with a plan to discontinue aspirin after one month and continue dual therapy thereafter.
On examination, his right dorsal pedis and posterior tibialis pulses were absent. His right heel had a mature eschar on the posterior aspect with no erythema, drainage, or odor noted in addition to wounds involving his second to fifth digits. Bedside Doppler showed a diminished signal at the dorsal pedis and absent signal at the right posterior tibial. X-ray of the foot demonstrated no evidence of osteomyelitis. His vascular arterial Duplex ultrasound showed an occluded right posterior tibial DVA. The distal anterior tibial artery was severely diseased with a distal occlusion and a monophasic waveform (Figure 1A and 1B). The distal peroneal and posterior tibial arteries were occluded. The plantar veins were studied with ultrasound for possible targets for hybrid DVA using a great saphenous vein to medial marginal vein bypass; however, this was not favored after discussing with vascular surgery. He was evaluated for right below knee amputation which he refused. He was then transferred to our facility to consider other treatment options for revascularization as a last resort. He had a peripheral angiogram that showed a patent distal aorta, iliac arteries, and femoropopliteal segments. The right anterior tibial artery was diffusely diseased with a 90% critical stenosis in its distal segment (Figure 2, Video A). The right distal peroneal, posterior tibial arteries and the right posterior DVA were occluded. After careful analysis of the angiogram, we proceeded with an intervention to the anterior tibial artery to establish direct foot perfusion. The left common femoral artery was accessed under ultrasound guidance using a micropuncture needle. A 4F IMA diagnostic catheter and a 0.035 angled Glidewire were used to access the contralateral right common iliac artery. The right SFA and profunda femoral arteries were heavily calcified without severe obstructive disease. The wire was advanced into the right popliteal artery and a 5F by 90 cm Cook Flexor Shuttle was advanced to the origin of the right anterior tibial artery for good support. An Asahi Sion Black 0.014 x 300 cm guidewire was advanced and used to cross the distal anterior tibial stenosis into the dorsal pedis artery. The distal wire was advanced into the first dorsal metatarsal branch after several attempts to wire across the pedal loop. A Corsair Asahi 150 cm microcatheter was then advanced into the dorsal pedis artery and selective foot angiogram was performed. A magnified view of the right foot showed a chronic total occlusion of the dorsal pedis (Figure 3, Video B). Laser atherectomy was performed with Philips Turbo Elite 0.9 mm catheter from the origin of the anterior tibial artery to the beginning of the dorsal pedis artery at 80/80 fluency/rate (Figure 4). This was followed by balloon angioplasty with coronary balloons since other balloons will not cross at rated pressure with multiple prolonged 5-minute inflations each of the entire vessel (Video C). A Coyote 2.5 x 220 mm balloon was used to further postdilate the anterior tibial artery obtaining excellent angiographic result with improvement of the blood flow into the dorsal pedis as well as the collaterals to the posterior tibial and its plantar branches (Videos D and E). The patient’s ischemic rest pain resolved and he was followed linearly along wound care with significant improvement few weeks later.
Over the past few years, percutaneous DVA has become a therapeutic alternative for patients with no-option CLTI. This procedure creates a percutaneous communication between a tibial artery and tibial vein rerouting oxygenated blood around the occluded arterial segments into the adjacent veins increasing perfusion to critically ischemic tissue in the foot.
The feasibility and safety of pDVA was demonstrated in the ALPS Registry. This was a multicenter, retrospective study that enrolled 32 consecutive patients with no option-CLTI (end stage or desert foot). The majority of patients had experienced failed prior attempts at revascularization. In this study, patients had an amputation-free survival of 84%, 71%, and 67% at 6 months, 12 months, and 24 months, respectively.2 Among them, 53% of had renal insufficiency and 16% were on dialysis. Freedom from major amputation was 80% at one year and successful wound healing was demonstrated in 73% of wounds at two years with a median time for complete wound resolution in 4.9 months. The PROMISE II trial primary completion date is expected to be in July 2021.
In contrast with femoropopliteal PTA, infrapopliteal balloon angioplasty has been offered predominantly to patients with CLTI and has produced more heterogeneous results.3 The primary patency of tibial vessel treated with balloon angioplasty alone ranges from 46-60% at 2 years.4 Negative predictors of limb salvage include dialysis and failure to improve runoff to the foot.5 Multiple observational studies have emphasized the importance of appropriate balloon sizing, angioplasty technique, and vessel preparation to optimize good angiographic results and minimize vessel recoil, dissection, or rupture. Different adjuvant treatment options are currently available for heavily calcified infrapopliteal vessels including rotational and orbital atherectomy, intravascular lithotripsy and laser atherectomy. We will expand on the latter as this was the strategy used for our patient. Excimer laser-assisted balloon angioplasty (LABA) can achieve excellent results in complex below-the-knee lesions. In the LIPS (Laser In Infrapopliteal and Popliteal Study) 93% of patients treated with laser followed by balloon angioplasty had TASC-D lesions with a high procedural success (97%). In 93 patients with end stage renal disease, all patients in LABA achieved <50% residual stenosis compared to 92.7% in PTA alone.6 The LACI trial (Limb salvage following laser-assisted Angioplasty for Critical limb Ischemia) was a multi-center prospective study conducted from April 2001 to April 2002 and included 145 patients enrolled at 11 US and 3 German centers. The primary end point was limb salvage (avoidance of a major amputation above the level of the ankle) among surviving patients at 6 months. The study included patients with CLTI and at least one angiographically identifiable tibial artery, poor candidates for surgical bypass due to absence of a suitable autologous vein or lack of undiseased distal vessel >1 mm in diameter, or high risk of surgical mortality. The procedural success was high (83%) with a limb salvage rate of 93% at 6 months. All patients received adjunctive balloon angioplasty and 45% of patients had a stent implantation. In this study, laser angioplasty for CLTI showed very good limb salvage rates in a very sick patient population who were unfit for traditional surgical revascularization.7
Initial studies from randomized controlled trials have shown comparable short-term outcomes of drug-coated balloon angioplasty vs standard balloon angioplasty in patients with CLI with infrapopliteal disease. Several systemic reviews and meta-analysis have shown no significant differences in limb salvage, survival, restenosis, target lesion revascularization, and amputation-free survival rates comparing both modalities.8 In the 5-year outcomes of the IN.PACT DEEP clinical drug-coated balloon trial, the freedom from CD-TLR and the incidence for amputation and all-cause mortality were similar with a trend favoring DCB. The rate of major amputation was numerically higher for DCB without reaching statistical significance (15.4% vs 10.6%; P=0.10).9 The Lutonix Global BTK registry showed greater primary patency and limb salvage at 6 months for the DCB group compared to the PTA group (74.7% vs 64.2%; P=0.02) and non-inferior freedom from major adverse limb events and peri-operative death between both groups at 30 days.10 The cumulative target lesion revascularization rate converged but still numerically favored the DCB group at 12 months. The ILLUMENATE BTK (Stellarex 0.014 drug-coated balloon) trial is currently enrolling and its resulted awaited.
In the case presented, we considered drug coated balloon vs standard angioplasty only following laser atherectomy. Based on the data, device availability and compatibility with a 5 French sheath we opted for standard PTA. Further studies in larger numbers of patients are still needed to definitively address the role of DCB technology in this setting and the question of optimal drug choice between cytotoxic vs cytostatic drug-coated balloon remains to be answered.
Percutaneous DVA is a novel interventional therapy for no-option CLTI patients. Long-term clinical outcomes are scarce and there is no data on optimal management strategies for patients presenting with ischemic wounds in the setting of occluded pDVA. Whether to attempt pDVA recanalization versus native vessel intervention, the optimal strategy is unclear and there may be pros and cons to each approach. This case highlights the clinical decision making in such a scenario and demonstrates how a reattempt at endovascular revascularization of the native vessel, albeit via indirect angiosomal flow, can still be a practical solution in the management of CLTI after failed pDVA in order to avoid limb amputation. Laser atherectomy in this case was important for lesion preparation and to establish adequate luminal gain and provide critical downstream blood flow to help heal the wounds.
Disclosure: The authors have completed and returned the ICMJE Form for Disclosure of Potential Conflicts of Interest. The authors report no financial relationships or conflicts of interest regarding the content herein.
Address for Correspondence:
Dr. Craig Walker, MD
Clinical Professor of Medicine – LSU School of Medicine, New Orleans, LA
Clinical Professor of Medicine – Tulane University School of Medicine, New Orleans, LA
Founder and President, Cardiovascular Institute of the South
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