Lower Extremity-Related Late-Breaking Abstracts From the International Symposium on Endovascular Therapy (ISET)

ISET 2022-5

Three-Year Results from the MIMICS-3D European Union Study

M. Lichtenberg

Purpose. The BioMimics 3D Vascular Stent System (Veryan Medical) delivers a nitinol stent designed to provide optimal radial support, flexibility, durability, visualization, and delivery accuracy for femoropopliteal intervention. BioMimics 3D’s unique 3-dimensional (3D) helical centerline provides biomechanical stability and compatibility, promotes swirling blood flow, and beneficially elevates wall shear stress. The MIMICS-3D European Registry investigated outcomes through 3 years in a real-world population with more challenging, complex lesions than were enrolled in earlier MIMICS studies. We present 3-year outcomes.

Materials and Methods. MIMICS-3D enrolled 507 participants treated with BioMimics 3D at 23 sites. Mean age was 70 years; 66% were male, and 37% had diabetes. Rutherford 0 to 1, 2 to 4, and 5 to 6 were 1%, 82%, and 17%, respectively. Mean lesion length was 126 mm; 57% occlusions; lesion calcification according to the Peripheral Arterial Calcium Scoring System was grade 0, 18%; 1, 29%; 2, 24%; 3, 15%; and 4, 14%. BioMimics 3D placement followed atherectomy in 8% of lesions. A drug-coated balloon was combined with BioMimics 3D in 50% of lesions treated. The technical success rate for the BioMimics 3D procedure as assessed by the operator was 99%. An independent clinical events committee adjudicated major adverse events (MAE), including death and potential device-related events. The primary safety endpoint is a composite of MAE, comprising death, major index-limb amputation, or clinically driven target lesion revascularization (CDTLR) through 30 days. Primary outcome measure for effectiveness is freedom from CDTLR though 12 months.

Results. Kaplan-Meier (KM) estimates of freedom from CDTLR at 1, 2, and 3 years in the intent-to-treat (ITT) population were 89%, 82%, and 78%, respectively. KM estimates of freedom from loss of primary stent patency (PSVR >2.4) at 1, 2, and 3 years in the ITT population were 87%, 79%, and 70%, respectively.

Conclusions. Three-year data from the MIMICS-3D European Union Study are consistent with those of earlier MIMICS studies and demonstrate that by promoting swirling blood flow and increasing wall shear stress, BioMimics 3D clinical outcomes are comparable to those of drug-eluting devices, even in challenging lesions.

ISET 2022-6

Prospective, Multicenter, CEC-Adjudicated Registry to Evaluate Safety and Efficacy of Radial to Peripheral Interventions

M. Shishehbor

Purpose. Radial arterial access has been shown to reduce vascular bleeding, complications, cost, length of stay, and mortality rate in patients undergoing intervention.

Materials and Methods. This was a prospective, multicenter, core-lab reviewed, clinical event committee (CEC)-adjudicated registry to evaluate the safety and efficacy of dedicated radial devices in complex peripheral vascular disease. A total of 120 patients at 8 US centers were enrolled from June 2020 to June 2021 and followed for 30 days, with a subset of stented participants followed for 12 months. The primary safety endpoint included evaluation of transradial access–related complications (bleeding, hand ischemia, hematoma, nerve damage, perforation, pseudoaneurysm, retinal artery occlusion, embolic stroke, or transient ischemic attack). The primary efficacy endpoint was procedural success, defined as successful completion of the intended procedure without transradial access complications during the procedure and conversion from radial to femoral access.

Results. A total of 224 lesions were treated. Initial access to radial artery was achieved in 120 of 120 (100%) of patients, with 1 patient requiring conversion to femoral access to complete thr procedure. Twenty-nine of 120 (24.2%) patients required 1 or more additional access sites to facilitate crossing or to complete the planned treatment algorithm (femoral, 5 [4.2%]; tibial, 6 [5.0%]; pedal, 17 [14.2%]; and other, 3 [2.5%]). Primary safety events defined as serious transradial access site–related adverse events occurred in 1 in 120 (0.8%). Twenty-four of 120 (20.0%) patients had nonserious transradial access site complications (minor hematoma, bruising, access site bleeding) requiring manual compression, longer transradial band application, or no further intervention. The primary efficacy endpoint (successful completion of the intended procedure without transradial access complications at procedure and conversion from radial to femoral access) was achieved in 115 of 120 (95.8%). The mean procedure time was 74 minutes, and the time to ambulation was 3 hours, 31 minutes.

Conclusions. This is the first prospective, multicenter study with core-lab and CEC adjudication to show the safety and efficacy of radial access in treating complex endovascular lesions in the lower limbs. A radial approach allowed 92.3% discharge on the day of the procedure with only 1 serious access site–related adverse event. Future randomized trials should examine the clinical and cost effectiveness of this approach over femoral access for patients with peripheral artery disease.

ISET 2022-15

6-Month Results From the PATHFINDER Registry Evaluating the Safety and Efficacy of the Auryon Laser

J. Rundback

Purpose. The purpose is to report the safety and efficacy of the Auryon Laser Atherectomy System (AngioDynamics) in a postmarket study treating infrainguinal lesions and occlusions.

Materials and Methods. In 104 patients (62.5% male; age 68.4 years ± 10.21 years; 53.8% with diabetes; 8.7% with chronic kidney disease; 46.1% with critical limb ischemia), 109 lesions were analyzed by an angiographic core lab. The average length was 13.54 cm (0.51–52.00 cm). There were 22.0% in-stent restenosis, 45.0% chronic total occlusions (CTOs), 43.1% tibial lesions, and 37.6% moderate to severely calcified. Outcomes were reported up until 6 months after the procedure.

Results. All the lesions were crossed. The stenosis percentages were 87.2% ± 16.47%, 60.7% ± 21.12%, and 24.2% ± 15.43% at baseline, post laser, and post procedure, respectively. There were no procedural perforations, amputations, or deaths. Five (4.1%) bail-out stentings were required after adjunctive therapy (not laser related), and 2 (1.7%) distal embolization events occurred and resolved intraprocedurally without complications. At 30 days (n = 103), 1 (1.0%) amputation, 1 (1.0%) clinically driven target lesion revascularization (CD-TLR), and 1 (1.0%) target vessel revascularizations (TVRs) were reported without relation to Auryon. At 6 months (n = 89), the freedom from major adverse events was 94.4%, with 3 (3.4%) CD-TLRs, 1 (1.1%) amputation, and 1 (1.1%) TVR reported. Rutherford, ankle-brachial index, and WIQ improved at 6 months (n = 69, 48, and 67, respectively) compared with baseline (3.69 ± 0.92 vs 1.68 ± 1.57; 0.73 ± 0.28 vs 0.86 ± 0.22; and 22.32 ± 22.50 vs 43.82 ± 27.99, respectively).

Conclusions. Initial postmarket data on real-world cases with Auryon in a variety of complex infrainguinal lesions demonstrate excellent safety and outcomes. Low CD-TLR rates with improved clinical presentation were consistent with prior data and stable out to 6 months.

ISET 2022-20

Single Pedal Access for Treatment of Ipsilateral Superficial Femoral Artery and Anterior Tibial Artery

N.E. Santana Sr., M.V. Troncoso

Purpose. Peripheral artery disease is a common condition that affects about 200 million people in the world. Treatment options include balloon angioplasty, bare-metal stents, drug-eluting stents, atherectomy, and distal tibial bypass surgery. Single retrograde access in the posterior tibial artery allows for precise deployment of self-expanding stents at the origin of the superficial femoral artery (SFA) when there are ostial lesions; however, it is challenging when it is necessary to also treat the ipsilateral anterior tibial artery. We present a successful case of angioplasty of the SFA and anterior tibial artery through a single access in the posterior tibial artery.

Materials and Methods. A 60-year-old woman with a history of hypertension and smoking for more than 15 years complained of rest pain in the left lower limb. Physical examination showed an absence of anterior and posterior tibial artery pulses of the left lower limb. Computed tomography angiography revealed ostial occlusion of the SFA and stenosis of 90% of the anterior tibial artery. After the patient signed informed consent, she was taken to the catheterization laboratory. Ultrasound guidance access of the left posterior tibial artery was performed with a micropuncture kit (Cook Medical). A 6 Fr sheet was placed. Command 0.018-inch wire (Abbott Vascular) and Sergeant 0.018-inch catheter (iVascular) were used to cross the lesion in the SFA. Oceanus Balloon Pro 3 mm × 200 and 5 mm × 150 mm (iVascular) were used for vessel preparation. Then a 5-mm × 150-mm Supera stent (Abbott Vascular) and 5-mm × 200-mm iVolution stent (iVascular) were deployed proximal and distal, respectively, in the SFA. A hydrophilic vertebral catheter and Asion blue wire 0.014 × 300 cm (Asahi) were used to cross the anterior tibial artery lesion, and plane balloon angioplasty was performed.

Results. Final arteriography showed satisfactory results with adequate blood flow. The patient left the catheterization laboratory with an anterior tibial artery palpable pulse.

Conclusions. Single retrograde access in posterior tibial artery allows precise deployment of a self-expanding stent in the ostium of the SFA and ipsilateral anterior tibial artery angioplasty in the same intervention, decreasing surgical time and use of contrast.

ISET 2022-22

Office-Based Peripheral Artery Disease Evaluation and Supervised Exercise Therapy Covered by Medicare (Michigan/Ohio Model)

R.R. Ross

Purpose. Supervised exercise therapy (SET) for symptomatic peripheral arterial disease (PAD) is now a Medicare-covered benefit.

Materials and Methods. Key points in the 2014 clinical evidence update included (1) management of intermittent claudication (IC) exercise program; (2) supervised exercise is associated with increases in maximal walking distance compared with home-based or other unsupervised exercise programs; (3) supervised exercise is associated with greater increases in walking distance in people with aortoiliac disease than either stenting or optimum medical care; and (4) supervised exercise appears to be more cost effective than either angioplasty alone or supervised exercise plus angioplasty in people with IC caused by femoropopliteal occlusion.

Results. The Centers for Medicare & Medicaid Services has determined that the evidence is sufficient to cover SET for beneficiaries with IC for the treatment of symptomatic PAD. Up to 36 sessions over a 12-week period are covered if all of the following components of a SET program are met: the SET program must be (1) conducted in a hospital outpatient setting or a physician’s office, and (2) under the direct supervision of a physician (as defined in 1861(r)(1)), physician assistant, or nurse practitioner or clinical nurse specialist (as identified in 1861(aa)(5)), who must be trained in both basic and advanced life support techniques.

Conclusions. PAD affects 12% to 20% of Americans aged 60 and older, and the incidence of PAD increases considerably with age. SET has been demonstrated to be an effective therapy to lessen the symptoms of claudication and improve walking distance in patients with PAD in numerous trials. Stakeholders such as the American Heart Association have long recommended SET as a first-line, noninvasive, low-risk therapy for individuals with PAD with claudication. Despite the disease burden and the substantial evidence supporting SET as a safe and effective treatment for PAD, it is currently covered by Medicare.

ISET 2022-28

Target Lesion Revascularization in Patients With Infrapopliteal Long-Segment Lesions Treated With Overlapping Everolimus-Eluting Coronary Stents

J. Watchmaker, R. Lookstein

Purpose. To evaluate clinical outcomes in patients with critical limb ischemia (CLI) and long-segment (>38 mm) infrapopliteal lesions treated with everolimus-eluting coronary stents (EESs) with prior failed angioplasty (percutaneous transluminal angioplasty [PTA]).

Materials and Methods. We reviewed outcomes in patients with long-segment lesions treated with EESs after failed PTA between January 2009 and September 2018. The primary endpoints were a composite of freedom from death from any cause through 30 days and freedom from target limb major amputation and clinically driven target lesion revascularization (CD-TLR) through 12 months analyzed via the Kaplan-Meier method. Log-rank test was used to compare differences between Rutherford groups (Rutherford 4 and 5 compared with Rutherford 6).

Results. Sixty-three patients (age 73.6 years ± 11.2 years; 4 female, 53 male), with 65 treated limbs met inclusion criteria. Thirty-seven Rutherford 4 or 5 limbs were included, and 28 Rutherford 6 limbs were included. Mean lesion length was 103.1 ± 52.6 mm (44.0–380 mm). The mean number of stents used was 2.8 (range, 2–10 stents) with a mean stent diameter of 3.4 mm (range, 2.5–4.0 mm). There were 11 deaths, 8 major amputations, and 7 CD-TLRs. Freedom from the composite endpoint was 70.6% for all patients. Patients with Rutherford 4 and 5 had an 84.6% freedom compared with those with Rutherford 6, with a 52.5% freedom from composite endpoint (hazard ratio, 4.0; 95% confidence interval, 1.5–10.6; P=.0059).

Conclusions. In patients with CLI, placement of multiple EESs in long-segment infrapopliteal lesions with prior failed PTA is a durable treatment option, with Rutherford 4 and 5 patients demonstrating markedly better outcomes as measured by freedom from death from any cause through 30 days and freedom from target limb amputation and CD-TLR through 12 months compared with Rutherford 6 patients.

Reprinted with permission from Vascular Disease Management 2022; 16(9): E55-72.  

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