Procedural and 3-Year Outcomes of Peripheral Vascular Interventions Performed in Office-Based Labs: LIBERTY 360 Sub-Analysis.

OBJECTIVE: Few data are available on the safety of interventions for peripheral arterial disease (PAD) performed in the office-based laboratory (OBL) setting. Thus, the aim of this study was to investigate the short- and late-term outcomes of patients treated in OBL vs hospital settings. METHODS: We included patients with PAD treated with any United States Food and Drug Administration approved or cleared devices for distal femoropopliteal and/or infrapopliteal disease. Data were retrieved from the LIBERTY 360 study. A propensity-scored, matched analysis was conducted and hazard ratios with the respective 95% confidence intervals were synthesized to examine the outcomes after interventions at OBL vs non-OBL settings. RESULTS: A total of 710 propensity-scored patients (355 OBL patients and 355 non-OBL patients) with 907 treated lesions (454 OBL lesions and 453 non-OBL lesions), were included. For almost all subjects, balloon angioplasty was the preferred treatment approach (341 [96.1%] in the OBL group vs 353 [99.4%] in the non-OBL group; P<.01), with bail-out stenting necessary in 5.1% of the OBL group and 3.1% of the non-OBL group. Overall, significant angiographic complications occurred in 7.8% of all patients treated, with no differences between the 2 groups. The risk for all-cause death, target-vessel revascularization, and major amputation and death combined was similar between the 2 groups during 3-year follow-up. CONCLUSIONS: Peripheral artery endovascular interventions in patients with chronic threatening ischemia or claudication, performed in the OBL setting, are safe and associated with favorable outcomes at 3 years of follow-up. These results demonstrate that treatment at OBLs is comparable to non-OBL settings. Further comparative studies and larger registries are needed to benchmark procedural quality and long-term outcomes.

Three-Year Outcomes of Orbital Atherectomy for the Endovascular Treatment of Infrainguinal Claudication or Chronic Limb-Threatening Ischemia.

Purpose: To investigate the outcomes of orbital atherectomy (OA) for the treatment of patients with peripheral artery disease (PAD) manifesting as claudication or chronic limb-threatening ischemia (CLTI). Materials and Methods: The database from the LIBERTY study (ClinicalTrials.gov identifier NCT01855412) was interrogated to identify 503 PAD patients treated with any commercially available endovascular devices and adjunctive OA for 617 femoropopliteal and/or infrapopliteal lesions. Cox regression analyses were employed to examine the association between baseline Rutherford category (RC) stratified as RC 2-3 (n=214), RC 4-5 (n=233), or RC 6 (n=56) and all-cause mortality, target vessel revascularization (TVR), major amputation, major adverse event (MAE), and major amputation/death at up to 3 years of follow-up. The mean lesion lengths were 78.7±73.7, 131.4±119.0, and 95.2±83.9 mm, respectively, for the 3 groups. Results: After OA, balloon angioplasty was used in >98% of cases, with bailout stenting necessary in 2.0%, 2.8%, and 0% of the RC groups, respectively. A small proportion (10.8%) of patients developed angiographic complications, without differences based on presentation. During the 3-year follow-up, claudicants were at lower risk for MAE, death, and major amputation/death than patients with CLTI. The 3-year Kaplan-Meier survival estimates were 84.6% for the RC 2-3 group, 76.2% for the RC 4-5 group, and 63.7% for the RC 6 group. The 3-year freedom from major amputation was estimated as 100%, 95.3%, and 88.6%, respectively. Among CLTI patients only, the RC at baseline was correlated with the combined outcome of major amputation/death, whereas RC classification did not affect TVR, MAE, major amputation, or death rates. Conclusion: Peripheral artery angioplasty with adjunctive OA in patients with CLTI or claudication is safe and associated with low major amputation rates after 3 years of follow-up. These results demonstrate the utility of OA for patients across the spectrum of PAD.

Lower extremity revascularization via endovascular and surgical approaches: A systematic review with emphasis on combined inflow and outflow revascularization.

This review is intended to help clinicians and patients understand the present state of peripheral artery disease, appreciate the progression and presentation of critical limb ischemia/chronic limb-threatening ischemia, and make informed decisions regarding inflow and outflow endovascular revascularization and surgical treatment options within the context of current debates in the medical community. A controlled literature search was performed to obtain research on outcomes of critical limb ischemia patients undergoing complete leg revascularization for peripheral artery disease inflow and outflow disease. Data for this review were identified by queries of medical and life science databases, expert referral, and references from relevant papers published between 1997 and 2019, resulting in 48 articles. The literature review herein indicates that endovascular revascularization-including ballooning, stenting, and atherectomy-is an effective peripheral artery disease therapy for both above the knee and below the knee disease, and can safely and effectively treat both inflow and outflow disease. As such, it plays a leading role in the therapy of lower extremity artery disease.

Intravascular Ultrasound Imaging Versus Digital Subtraction Angiography in Patients with Peripheral Vascular Disease.

OBJECTIVES: The evaluation of arterial plaque morphology and vessel diameter is a vital component of peripheral vascular interventions. Historically, digital subtraction angiography (DSA) has been considered the gold standard for vessel sizing and treatment. However, this modality has the limitation of providing a two-dimensional image of a three-dimensional luminal structure. Utilization of intravascular ultrasound (IVUS) has been incorporated into diagnostic and treatment algorithms to further characterize the arterial vessel. This study compared visual estimation of vessel diameter by angiographic imaging with IVUS measurements. METHODS: A retrospective analysis was conducted on a cohort of 43 patients who underwent an endovascular intervention utilizing DSA and IVUS imaging. Angiographic measurements were determined by an interventionalist blinded to the IVUS findings. RESULTS: Of the 43 patients, 58% were male, the majority (72%) were ages 60-89 years, 58% were Rutherford classification III, and 42% had critical limb ischemia (Rutherford classification IV or V). Arterial access sites were common femoral, posterior tibial, and anterior tibial in 37%, 37%, and 26%, respectively. Tibiopedal arterial minimally invasive (TAMI) retrograde revascularization was utilized in 63% of patients. Vessel sizing was consistently the same or smaller for female subjects with either imaging modality. Overall, measurements estimated from angiographic images were significantly smaller than those obtained from IVUS analysis. CONCLUSION: IVUS appears to offer a greater degree of accuracy in measuring arterial lumen diameter. As measurements obtained from angiographic imaging consistently under-estimated vessel size, utilization of IVUS may aid in the determination of treatment algorithms and lead to improved endovascular outcomes.

Clinical application and early outcomes of the aortouni-iliac configuration for endovascular aneurysm repair.

OBJECTIVE: The objective of this study was to review the current anatomic indications for and early results of aortouni-iliac (AUI) devices for endovascular aneurysm repair. METHODS: A total of 128 patients receiving an Endurant (Medtronic Inc, Minneapolis, Minn) AUI device in the U.S. Investigational Device Exemption trial (44 patients) or the Endurant Stent Graft Natural Selection Global Postmarket Registry (84 patients) were reviewed. Preoperative computed tomography imaging of patients in the Investigational Device Exemption trial and case report forms of Registry patients were used to determine anatomic indications. Baseline characteristics and early results were compared with those of 1305 patients receiving a bifurcated (BIF) device in sister studies. RESULTS: The indication for the AUI device was unclear from case report forms in two Registry cases. The remaining 126 patients had a unilateral iliac occlusion in 30 (23%), a severely narrowed aortic segment in 58 (45%), severe iliac occlusive disease in 28 (22%), severe iliac tortuosity in 29 (23%), or complex iliac aneurysms in 19 (15%). Two patients had a previous aortobifemoral graft; 38 patients (30%) had multiple indications. The AUI cohort included more women than the BIF group did (19% vs 10%; P < .01) and had more severe comorbidities. Successful deployment was achieved in all AUI cases. The 30-day mortality was 2% (BIF cohort, 1%; P = .21). More AUI patients underwent repair under general anesthesia (81% vs 64%; P < .01), and procedures were longer (110.9 ± 54.9 minutes vs 99.2 ± 44.3 minutes; P = .02). Except for longer intensive care unit stays (19.6 ± 80.0 hours vs 9.0 ± 34.8 hours; P = .01) and higher myocardial infarction rates (4% vs 1%; P < .01), outcomes of the AUI cohort were similar to those of the BIF cohort. There were no migrations, ruptures, fractures, or open conversions at up to 1-year follow-up. CONCLUSIONS: The AUI configuration extends endovascular aneurysm repair feasibility to several hostile anatomic conditions. Despite increased comorbidities in the recipient patient population and associated higher rates of postoperative myocardial infarction and respiratory complications, early outcomes with the new generation of AUI devices are acceptable and comparable to those after treatment with BIF configurations.