Faculty Bibliography

BACKGROUND/UNASSIGNED:Radial access (RA) may offer advantages in peripheral interventions, but previous studies on this approach have been limited to retrospective or single-center studies. Our aim was to prospectively evaluate the safety and feasibility of RA for complex endovascular lower extremity interventions. METHODS/UNASSIGNED:In this prospective, multicenter, and observational study, eligible patients with peripheral artery disease scheduled for intervention through RA were enrolled. Primary efficacy end point was procedural success, defined as successful completion of the intended procedure without conversion to femoral access and without RA complications periprocedure. Primary safety end point included evaluation of RA-related complications at 30 days. RESULTS/UNASSIGNED:From June 2020 to June 2021, 120 patients at 8 US centers were enrolled. Mean age was 68.7 years, and 31.7% were women. The 224 lesions treated were in iliac (12.9%), femoropopliteal (55.3%), isolated popliteal (11.9%), and tibial (19.5%) vessels. The primary efficacy end point was achieved in 112 (93.3%) patients. One patient (<1%) required femoral access conversion to complete the procedure. Thirty (25.0%) patients required 1 or more additional access to facilitate crossing and/or to complete the planned treatment (5 femoral, 10 tibial, and 17 pedal accesses). No serious adverse events were adjudicated to the procedure. Mean procedure time and time to ambulation was 74 minutes and 3 hours 30 minutes; respectively, with 93.3% same-day discharge. At 30 days, 97.2% of patients recorded ultrasound-confirmed RA patency. CONCLUSIONS/UNASSIGNED:This is the first prospective and multicenter registry to show the safety and efficacy of RA approach for complex endovascular lesions and multilevel disease. RA allowed early ambulation and same-day discharge with no serious adverse events. Future randomized trials should examine the clinical and cost effectiveness of this approach compared with those of femoral access for patients with peripheral artery disease.

PURPOSE/OBJECTIVE:To investigate the clinical implication of additional below-the-ankle (BTA) intervention in patients with chronic limb-threatening ischemia (CLTI) undergoing below-the-knee (BTK) intervention. MATERIALS AND METHODS/METHODS:.gov identifier NCT01855412), a prospective, observational, core-laboratory adjudicated, multicenter study of endovascular intervention in 1204 patients. Patients with CLTI (Rutherford Classification 4-6) who underwent BTK intervention were included in this sub-analysis. Participants were then stratified into 2 treatment groups according to whether at least one lesion intervened on was BTA (n=66) or not (n=273). The decision on whether and where to intervene was made during the procedure. The main outcome measures included major amputation, target vessel revascularization (TVR), major adverse events (MAE), survival, amputation-free survival, major adverse limb events or peri-operative death (MALE-POD), and all-cause death. Other outcome measures included procedural success, procedural complications, and wound healing rate. RESULTS:There were no differences in procedural success or severe angiographic complications between the 2 groups. At 1-year post-procedure, patients in the BTK group had a higher rate of freedom from major amputation (95.0% vs. 86.9%, respectively; HR: 2.87, 95% CI: 1.17-7.03), a higher rate of freedom from TVR (80.1% vs. 66.9%, respectively; HR: 1.94, 95% CI: 1.14-3.32), a higher rate of freedom from MALE-POD (94.6% vs. 86.9%, respectively; HR: 2.65, 95% CI: 1.10-6.41), and a higher rate of freedom from MAE at both 1 (76.0% vs. 60.1%, respectively; HR: 2.00, 95% CI: 1.24-3.22) and 3 years post procedure (67.5% vs. 55.8%, respectively; HR: 1.69, 95% CI: 1.08-2.65). There was a significantly lower rate of survival in the BTK group at 3 years (74.3% vs. 91.1%, respectively; HR: 0.35, 95% CI: 0.14-0.87). After risk adjustment, there was a higher rate of all-cause death in the BTK group at 3 years (19.4% vs. 9.1%, respectively; p=0.023) post-intervention. CONCLUSION/CONCLUSIONS:Patients with disease requiring intervention to BTA lesions have a potential increased amputation rate in the short term, but BTA intervention carries a potential survival benefit in the long term when compared to BTK intervention alone.

BACKGROUND/PURPOSE:The transradial approach has been proposed as an alternative to traditional transfemoral access for diagnostic and therapeutic purposes in several catheterization procedures. Historically, extended length devices for lower limb endovascular interventions have been limited. The aim of this study was to investigate the acute clinical outcomes of orbital atherectomy (OA) via transradial access (TRA) for the treatment of lower extremity peripheral artery disease (PAD). METHODS/MATERIALS:REACH PVI was a multicenter, prospective, observational study (NCT03943160) including subjects with PAD and target lesion morphology appropriate for OA. All patients were followed post-procedure through the first standard of care follow-up visit. RESULTS:A total of 50 patients were enrolled. In most cases the indication for intervention was disabling claudication (74.0%). Overall, 50 target lesions were treated, 92.0% of lesions were femoropopliteal and 8.0% were infrapopliteal. The average lesion length was 98.3 ± 87.5 mm and 78.0% of the lesions were severely calcified. Balloon angioplasty was performed in 98.0% of target lesions, while a stent was deployed in 16.0%. Treatment success was 98.0%; in only one case the result was sub-optimal (>30% stenosis with stent placement) and a significant dissection was reported. No serious distal embolization, serious thrombus formation or serious acute vessel closure were observed intra- or post-procedurally. CONCLUSIONS:Transradial OA followed by percutaneous transluminal angioplasty for lower extremity PAD is feasible and demonstrates a favorable safety profile. Extended length devices such as the Extended Length Orbital Atherectomy System could further facilitate transradial endovascular procedures by increasing its spectrum of application.

BACKGROUND:Transpedal access is increasingly utilized for the treatment of peripheral artery disease (PAD). Femoral-popliteal artery chronic total occlusions (CTOs) are some of the most difficult lesion subsets that sometimes require the use of re-entry support devices during percutaneous intervention. Limited data is available on the use of re-entry devices when treating femoral-popliteal CTOs via transpedal access. The aim of this study was to demonstrate the feasibility of using the Outback® Elite re-entry device for the treatment of femoral-popliteal CTOs via the transpedal approach in an outpatient based lab setting. METHODS:Seventeen patients presented with femoral-popliteal CTOs in which treatment required the use of the Outback® Elite re-entry device. All procedures were performed in a single outpatient based lab. Patients were followed at 1 week and 1 month post-procedure, with lower extremity arterial duplex ultrasound assessment during the 1 month follow-up. RESULTS:The average patient age was 78 years-old, with 71% being males. Most patients presented with Rutherford class IV symptoms. Procedural success was achieved in all patients with no requirement to convert to femoral artery access in any of the cases. No immediate post-procedural complications nor at any time during follow-up were observed. Ultrasonography at 1 month follow-up showed patent intervention sites and access site vessels in all patients. CONCLUSION/CONCLUSIONS:The use of the Outback® Elite re-entry device for the treatment of femoral-popliteal CTOs via transpedal access is a feasible option and may have potential benefits by avoiding risks associated with traditional femoral artery access.

We describe a rare case of an exceptionally large pseudoaneurysm that developed in the right common femoral artery 6 months after an electrophysiological study. Surgical and other conventional methods to treat his pseudoaneurysm were not feasible. Therefore, the pseudoaneurysm was successfully treated via an endovascular approach with a covered stent. (Level of Difficulty: Beginner.).

Growing endovascular strategies with TASC D lesions in aortoiliac disease reflect increasing technical success with evidenced safety and efficacy. In cases of failed transfemoral access, revascularization of iliac chronic total occlusions has prompted the utilization of other alternate access sites (e.g. transradial and transbrachial approaches) as important options in aortoiliac TASC D lesions. We describe a case of successful revascularization of an occluded ostial left common iliac artery in an 81-year-old man using a dual ulnar and tibioperoneal approach (absent radial artery). A Controlled Antegrade and Retrograde Tracking technique was performed where a balloon was advanced from the peroneal artery into the distal cap of the chronic total occlusion in the proximal common femoral artery. Balloon inflation was performed and a glidewire from transulnar access was advanced and re-entered into the true lumen in the common femoral artery. The wire was then snared and externalized out the transpedal access site creating a continuous true lumen from the ulnar artery to the peroneal artery. To reconstruct the aortic bifurcation, kissing balloon inflations were performed from the peroneal as well as the ulnar artery approaches. A 10 mm × 59 mm balloon expandable stent was placed in the ostial left common iliac artery and a 8 mm × 60 mm self-expanding stent was placed in the left external iliac artery successfully.

BACKGROUND:With the advent of endovascular techniques, alternate sites such as the pedal and radial arteries can now be accessed when treating peripheral arterial disease to reduce procedural complications, shorten recovery time, and improve patient comfort. However, a paucity of literature exists on the availability of support devices that can be utilized during challenging cases. CASE PRESENTATION/METHODS:A 70 year-old female patient presented for evaluation of severe lifestyle-limiting left-sided claudication refractory to maximal medical therapy. Angiography revealed a chronic total occlusion of the left external iliac artery, which was treated successfully by percutaneous intervention via a primary transpedal approach and with the assistance of the Outback® Elite re-entry device. The patient was discharged 2 h after the procedure and reported significant symptom improvement at follow-up. CONCLUSION/CONCLUSIONS:This case highlights a newly adopted endovascular approach through an alternate access site and illustrates how the Outback® Elite device can be used as an adjunctive tool in the treatment of complex lower-extremity vascular lesions.

BACKGROUND:A pseudoaneurysm is a rare but serious complication after transradial coronary catheterization. Although different treatment modalities have been proposed to treat post-catheterization pseudoaneurysm, only limited data are available to guide the treatment approach. CASE PRESENTATION/METHODS:We report a rare case of two distinct pseudoaneurysms complicating transradial percutaneous coronary intervention in a 75-year-old Hispanic woman being treated with dual antiplatelet agents for myocardial infarction and warfarin for atrial fibrillation. The pseudoaneurysms were diagnosed with ultrasound and were successfully treated with a series of Terumo Corporation (TR) band compressions. CONCLUSIONS:This case demonstrates the efficacy of compression therapy in managing post-catheterization radial artery pseudoaneurysm in patients with high bleeding risk.

BACKGROUND:There has been an increasing use of transpedal arterial access (TPA) for evaluation and treatment of peripheral arterial disease (PAD) over a transfemoral approach (TFA). TPA, it is expected to be associated with better patient comfort, less recovery time and possibly less access site complications compared to standard TFA. Access site complications and pseudoaneurysm (PSA) associated with the TPA have not been previously reported. OBJECTIVE:Here we report a series of pedal artery PSA related to access site complicating TPA catheterization. METHODS:We studied 1460 patients with symptomatic PAD who underwent 2236 peripheral diagnostic and/or interventional procedures between 06/2014 and 01/2016 via TPA. Hemostasis was achieved using patent hemostasis technique by a radial artery compression device for 2h. PSA related to the access site were suspected clinically and confirmed with arterial duplex ultrasound. RESULTS:The incidence of PSA related to any access site was 0.002%. In this series all PSA occurred only in the posterior tibial artery, after an interventional procedure. All patients were treated successfully with thrombin injection with no residual complications. CONCLUSIONS:PSA associated with TPA is extremely rare and seems to occur exclusively after posterior tibial artery access. It is easily treatable by thrombin injection.

OBJECTIVE:To demonstrate the safety and feasibility of the transpedal approach as an alternate arterial access site for iliac artery intervention. BACKGROUND:The common femoral artery is the traditional access site for the endovascular treatment of iliac artery stenoses. However, this approach is associated with complication rates as high as 2%, including retroperitoneal bleeding which carries high patient morbidity and mortality. Furthermore, the standard femoral approach is associated with longer recovery times and longer time to ambulation which are important considerations especially when performing procedures in an ambulatory setting. METHODS:Twelve patients were prospectively followed after treatment for symptomatic iliac artery stenosis via transpedal access. Under ultrasound guidance, one of the pedal arteries was visualized and accessed, and stenting of the iliac arteries were performed as per protocol. The patient was monitored immediately post procedure and clinical follow up was performed at one week and one month later. RESULTS:The average age of the patients was 71years old. 58% were male. Most patients had Rutherford class III symptoms. Successful stent placement was achieved in all 12 patients via transpedal access. No conversion to femoral access was required. No complications immediately post procedure nor at any time period during follow up were noted. Lower extremity arterial duplex at one month showed patent stents and patent pedal access site vessels in all patients. CONCLUSION/CONCLUSIONS:Transpedal arterial access may be a safe and feasible approach for iliac artery stenting. Given the possible benefits of avoiding femoral artery access, larger studies should be conducted directly comparing the different approaches.