DETOUR2 trial outcomes demonstrate clinical utility of percutaneous transmural bypass for the treatment of long segment, complex femoropopliteal disease.

OBJECTIVE: Percutaneous transmural arterial bypass (PTAB) using the DETOUR system aims to create a percutaneous, endovascular femoropopliteal bypass for the treatment of long segment, complex superficial femoral and proximal popliteal artery disease. The goal of the DETOUR2 study is to investigate the safety and effectiveness of the therapy in comparison with pre-established performance goals. METHODS: The DETOUR2 investigational device exemption study is a prospective, single-arm, multicenter, international trial of symptomatic peripheral arterial disease patients (Rutherford classes 3-5) undergoing the DETOUR procedure for long segment (>20 cm) superficial femoral artery disease. Prespecified end points included primary safety (composite of major adverse events) at 30 days, and effectiveness (primary patency defined as freedom from restenosis or clinically driven target lesion revascularization) at 1 year. RESULTS: We enrolled 202 patients at 32 sites with 200 treated with the DETOUR system. The mean lesion length was 32.7 cm, of which 96% were chronic total occlusions (CTO) and 70% were severely calcified. Technical success was achieved in 100% of treated patients. The primary safety end point was met with a 30-day freedom from major adverse event rate of 93.0%. The 1-year primary effectiveness end point was met with 72.1% primary patency at 12 months. Primary-assisted and secondary patency were 77.7% and 89.0%, respectively, at 12 months. The 12 month deep venous thrombosis incidence was 4.1% with no pulmonary emboli reported. Venous quality-of-life scores showed no significant changes from baseline. There was a Rutherford improvement of at least one class through 12 months in 97.2% of patients. The mean ankle-brachial index also improved from 0.61 to 0.95 during this period. There were marked improvements in quality-of-life and functional status measures. CONCLUSIONS: The DETOUR2 study met both the primary safety and effectiveness end points, demonstrating clinical usefulness of this novel therapeutic strategy in long femoropopliteal lesions.

Cost-effectiveness analysis of intravascular ultrasound-guided peripheral vascular interventions in patients with femoropopliteal peripheral artery disease.

Background: Intravascular ultrasound (IVUS)-guided percutaneous transluminal angioplasty (PTA) might offer clinical benefits compared to angiography-guided PTA in patients with peripheral artery disease (PAD). A cost-effectiveness model was developed to examine the benefits and costs of IVUS-guided PTA versus angiography-guided PTA in PAD patients with femoropopliteal (FP) occlusive disease. Methods: A two-step model (a one-year decision tree followed by a lifetime semi-Markov model) was developed from a German healthcare payer perspective to estimate the costs and outcomes over a one-year and lifetime horizon. Clinical events included target lesion revascularization (TLR), amputation, and death. Transition probabilities and utility values were derived from published literature. Healthcare costs were based on German Diagnosis Related Groups (DRG) codes. Costs and outcomes were discounted at a rate of 3% per year. The incremental cost-effectiveness ratio (ICER) was calculated, and sensitivity analyses were performed to assess the robustness of the results. Results: In the one-year horizon, IVUS-guided PTA resulted in incremental quality-adjusted life-years (QALY) and costs of 0.02 and €919 per patient respectively, with a corresponding ICER of €45,195/QALY gained versus angiography-guided PTA. In the lifetime horizon, IVUS-guided PTA outperforms angiography-guided PTA; it was associated with a cost saving of €46 per patient and incremental QALY of 0.22. Utility value for post-TLR, as well as probabilities of death and TLR had the greatest impact on the one-year ICER, while cost of TLR and probabilities of TLR and amputation influenced the lifetime ICER most. The probability of IVUS-guided PTA being cost-effective at a willingness-to-pay (WTP) threshold of €50,000/QALY was 50.4% in the one-year horizon and increased to 85.9% in the lifetime horizon. Conclusions: In this analysis IVUS-guided PTA among patients with symptomatic FP atherosclerosis was cost-saving in a lifetime horizon from the German healthcare payer perspective.

Primary results of the SAVAL randomized trial of a paclitaxel-eluting nitinol stent versus percutaneous transluminal angioplasty in infrapopliteal arteries.

BACKGROUND: Effective and durable options for infrapopliteal artery revascularization for patients with chronic limb-threatening ischemia (CLTI) are limited. METHODS: The SAVAL trial is a prospective, multicenter, randomized trial of patients with CLTI and infrapopliteal artery lesions with total lesion length ⩽ 140 mm, stenosis ⩾ 70%, and Rutherford category 4-5 assigned 2:1 to treatment with the SAVAL self-expandable paclitaxel drug-eluting stent (DES) or percutaneous transluminal angioplasty (PTA) with an uncoated balloon. The primary effectiveness endpoint was primary vessel patency (i.e., core lab-adjudicated duplex ultrasound-based flow at 12 months in the absence of clinically driven target lesion revascularization or surgical bypass of the target lesion). The primary safety endpoint was the 12-month major adverse event (MAE)-free rate; MAEs were defined as a composite of above-ankle index limb amputation, major reintervention, and 30-day mortality. The endpoints were prespecified for superiority (effectiveness) and noninferiority (safety) at a one-sided significance level of 2.5%. RESULTS: A total of 201 patients were enrolled and randomly assigned to treatment (N = 130 DES, N = 71 PTA). Target lesion length was 68.1 ± 35.2 mm for the DES group and 68.7 ± 49.2 mm for the PTA group, and 31.0% and 27.6% of patients, respectively, had occlusions. The 12-month primary patency rates were 68.0% for the DES group and 76.0% for the PTA group (Psuperiority = 0.8552). The MAE-free rates were 91.6% and 95.3%, respectively (Pnoninferiority = 0.0433). CONCLUSION: The SAVAL trial did not show benefit related to effectiveness and safety with the nitinol DES compared with PTA in infrapopliteal artery lesions up to 140 mm in length. Continued innovation to provide optimal treatments for CLTI is needed. (ClinicalTrials.gov Identifier: NCT03551496).

Incidence of adverse cardiovascular events in patients with insomnia: A systematic review and meta-analysis of real-world data.

Insomnia is a prevalent sleeping disorder associated with increasing cardiovascular (CV) mortality and morbidity. However, data incorporating recent clinical studies evaluating these outcomes is scarce. Hence, we aimed to investigate the association of insomnia with CV mortality, myocardial infarction (MI), all-cause mortality, and incidence of CV disease by conducting the first-ever meta-analysis of real-world data evaluating these CV outcomes. MEDLINE and Scopus databases were queried till August 2022 to identify studies comparing prespecified outcomes in patients with and without insomnia. The primary outcomes were CV mortality and myocardial infarction, while secondary outcomes included all-cause mortality, and CV-disease incidence. All data were pooled using an inverse-variance weighted random-effects model, and results were reported as relative risks (RRs) and p-values. 21 studies were analyzed. Risks for CV mortality and MI were significantly higher in patients with insomnia (RR 1.53, p<0.01, and RR 1.48, p = 0.03, respectively). The risk for all-cause mortality and CV disease incidence was also significantly higher in insomnia patients (RR 1.14, p = 0.03, and RR 1.31, p<0.01, respectively). Individuals with insomnia experience a higher risk of long-term mortality, MI, and incidence of CV disease.

Best crossing of peripheral chronic total occlusions.

Together with colleagues from different disciplines, including cardiologists, interventional radiologists and vascular surgeons, committee members of the of the German Society of Angiology (Deutsche Gesellschaft für Angiologie [DGA]), developed a novel algorithm for the endovascular treatment of peripheral chronic total occlusive lesions (CTOs). Our aim is to improve patient and limb related outcomes, by increasing the success rate of endovascular procedures. This can be achieved by adherence to the proposed crossing algorithm, aiding the standardization of endovascular procedures. The following steps are proposed: (i) APPLY Duplex sonography and if required 3D techniques such as computed tomography or magnetic resonance angiography. This will help you to select the optimal access site. (ii) EVALUATE the CTO cap morphology and distal vessel refilling sites during diagnostic angiography, which are potential targets for a retrograde access. (iii) START with antegrade wiring strategies including guidewire (GW) and support catheter technology. Use GW escalation strategies to penetrate the proximal cap of the CTO, which may usually be fibrotic and calcified. (iv) STOP the antegrade attempt depending on patient specific parameters and the presence of retrograde options, as evaluated by pre-procedural imaging and during angiography. (v) In case of FAILURE, consider advanced bidirectional techniques and reentry devices. (vi) In case of SUCCESS, externalize the GW and treat the CTO. Manage the retrograde access at the end of the endovascular procedure. (vii) STOP the procedure if no progress can be obtained within 3 hours, in case of specific complications or when reaching maximum contrast administration based on individual patient's renal function. Consider radiation exposure both for patients and operators. In this manuscript we systematically follow and explain each of the steps (i)-(vi) based on practical examples from our daily routine. We strongly believe that the integration of this algorithm in the daily practice of endovascular specialists, can improve vessel and patient specific outcomes.

Crossing Algorithm for Infrainguinal Chronic Total Occlusions: An Interdisciplinary Expert Opinion Statement.

A crossing algorithm was developed for the endovascular treatment of peripheral chronic total occlusive lesions (CTOs) to educate, guide, and appropriately influence clinical practice aiming at harmonization and standardization of endovascular procedures. The following steps are proposed: One, duplex sonography and if required computed tomography or magnetic resonance angiography for the selection of the optimal access site. Two, angiographic evaluation of the proximal/distal cap morphology, presence of collaterals at the origin of the proximal cap and at the distal vessel refilling site. In addition, evaluation of distal vessels, including their diameters and quality, and the presence of calcification or stents within the occlusion zone. Three, antegrade wiring strategies, guidewire (GW) and support catheter technology, as well as GW escalation strategies. Stop the antegrade attempt depending on clinical indication for peripheral artery disease treatment and the presence of retrograde options. Four, retrograde access site, support catheter, or sheath insertion and wiring technology from distally. Five, considering strategy change when progress cannot by achieved, using advanced bidirectional techniques and re-entry devices. Six, in case of successful GW passage from retrograde, GW externalization and treatment from antegrade. Management of the retrograde access by internal or external hemostasis at the end of the procedure. Alternatively, stop the procedure if no progress can be obtained within 3 hours or in case of specific complications. By establishing the algorithm in the daily routine of endovascular specialists, improvements in vessel- and patient-specific outcomes are anticipated. In addition, future research, and continuous collaboration between experts is warranted.

Clinical Outcomes of Additional Below-The-Ankle Intervention Compared to Below-The-Knee Intervention Alone: A Post-Hoc Analysis of a Prospective Multicenter Study.

PURPOSE: 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: A sub-analysis was performed using data from the LIBERTY trial (ClinicalTrials.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: 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.

Closing the Gaps in Racial Disparities in Critical Limb Ischemia Outcome and Amputation Rates: Proceedings from a Society of Interventional Radiology Foundation Research Consensus Panel.

Minority patients such as Blacks, Hispanics, and Native Americans are disproportionately impacted by critical limb ischemia and amputation due to multiple factors such as socioeconomic status, type or lack of insurance, lack of access to health care, capacity and expertise of local hospitals, prevalence of diabetes, and unconscious bias. The Society of Interventional Radiology Foundation recognizes that it is imperative to close the disparity gaps and funded a Research Consensus Panel to prioritize a research agenda. The following research priorities were ultimately prioritized: (a) randomized controlled trial with peripheral arterial disease screening of at-risk patients with oversampling of high-risk racial groups, (b) prospective trial with the introduction of an intervention to alter a social determinant of health, and (c) a prospective trial with the implementation of an algorithm that requires criteria be met prior to an amputation. This article presents the proceedings and recommendations from the panel.

Outcomes of Orbital Atherectomy in Patients with Critical Limb Threatening Ischemia and Diabetes.

Purpose: Patients with diabetes and critical limb threatening ischemia (CLTI) are at significantly higher risk of limb loss and death. Here we evaluate the outcomes of orbital atherectomy (OA) for treatment of CLTI in patients with and without diabetes. Methods: Retrospective analysis of the LIBERTY 360 study was performed to evaluate baseline demographics, and peri-procedural outcomes between patients with CLTI, and with and without diabetes. Hazard ratios (HRs) were determined with Cox regression to examine the impact of OA in patients with diabetes and CLTI over a 3-year follow-up. Results: A total of 289 patients (201 with diabetes, 88 without diabetes) with Rutherford classification 4-6 were included. Patients with diabetes had higher proportion of renal disease (48.3% vs 28.4%, p=0.002), prior minor/major limb amputation (26% vs 8%, p<0.005), and presence of wounds (63.2% vs 48.9%, p=0.027). Operative times, radiation dosage, and contrast volume were similar between groups. The rate of distal embolization was higher in patients with diabetes (7.8% vs 1.9%, p=0.01; OR 4.33 [0.99, 18.88], p=0.05). However, at 3-years post-procedure, patients with diabetes had no differences in freedom from target vessel/lesion revascularization (HR 1.09, p=0.73), major adverse events (MAE; HR 1.25, p=0.36), major target limb amputation (HR 1.74, p=0.39), and death (HR 1.11, p=0.72). Conclusion: The LIBERTY 360 observed high limb preservation and low MAEs in patients with diabetes and CLTI. Higher distal embolization was observed with OA in patients with diabetes, but OR did not indicate a significant difference in risk between groups.

A systematic review of the ipsilateral retrograde approach to the treatment of femoropopliteal arterial lesions.

OBJECTIVE: The endovascular treatment of femoropopliteal lesions is an integral part of managing peripheral arterial disease. The antegrade approach is the most widely used technique with good evidence for its safety and efficacy. However, crossing a lesion, particularly chronic total occlusions (CTO), can be technically challenging and so the retrograde approach is increasingly used to maximize the chances of procedural success. The objective of this systematic review was, therefore, to assess the safety and effectiveness of the ipsilateral retrograde approach to femoropopliteal lesions. METHODS: A systematic review conforming to the PRISMA standards was undertaken. MEDLINE, EMBASE, and The Cochrane Register were searched between January 1, 1988, and January 1, 2020. Full-text, English-language, peer-reviewed articles pertaining to peripheral arterial disease, endovascular intervention and access site were included. RESULTS: A total of 8599 articles were screened, of which 38, involving 1940 patients undergoing 2184 retrograde procedures, were included. The mean number of patients per study was 51.1, with three studies including fewer than 10 and four more than 100 patients. The reported follow-up ranged from 30 days to 3 years, and six articles did not report any long-term outcome data. A retrograde approach was used as the primary access route in 45.% of procedures (648/1438) with relevant data. Primary technical success was achieved in 88% (1920/2184; 64%-100%) with a reported complication rate of 11% (235/2117; 0%-27%). Overall, the quality of evidence was poor, with just seven articles deemed to be of high quality with a low risk of bias. A meta-analysis was not deemed appropriate owing to heterogeneity of data. CONCLUSIONS: An ipsilateral retrograde approach to femoropopliteal lesions has good primary technical success and a low rate of complications. It has a promising role as a bailout, or even a primary access technique, in complex lesions. Patient positioning, puncture site and technique, lesion anatomy, and the size of catheters and devices used are important considerations to achieve the best outcomes. There remains a paucity of robust evidence for its superiority over traditional antegrade approaches, and further work is required to identify the optimal technique and those patients who would benefit most from the approach.

PROMISE I: Early feasibility study of the LimFlow System for percutaneous deep vein arterialization in no-option chronic limb-threatening ischemia: 12-month results.

OBJECTIVE: We report the 6- and 12-month outcomes of the PROMISE I early feasibility study after treatment of no-option chronic limb-threatening ischemia (CLTI) with percutaneous deep vein arterialization (pDVA) using the LimFlow System. METHODS: Thirty-two patients with no-option CLTI, previously offered major amputation, were enrolled in this single-arm early feasibility study of the LimFlow pDVA System. No-option CLTI was defined as being ineligible for surgical or endovascular arterial revascularization. Patients were assessed for clinical status, pain, wound healing, and duplex ultrasound at 30 days, 6 months, and 12 months post-treatment. Primary endpoint analysis was amputation-free survival (AFS) at 30 days and 6 and 12 months. AFS was defined as freedom from above-ankle amputation of the index limb and freedom from all-cause mortality. Secondary endpoints evaluated included technical success of the procedure, and wound healing at 6 and 12 months. RESULTS: Of 32 enrolled patients, 31 (97%) were successfully treated with the LimFlow System at the time of the procedure, and two (6.3%) were lost to follow-up. The 30-day, 6-month, and 12-month AFS rates were 91%, 74%, and 70% respectively. The wound healing status of fully healed or healing was 67% at 6 months, and 75% at 12 months. Reintervention was performed in 16 patients (52%) with 14 (88%) of the maintenance reinterventions occurring within the first 3 months. The majority of reinterventions (n = 12; 75%), involved the arterial inflow tract proximal to the stented LimFlow circuit, and no in-stent stenoses were determined to have been the cause of reintervention. CONCLUSIONS: The LimFlow pDVA System was utilized in treating patients with no-option CLTI. A high technical success rate was observed, with a significant percentage of patients surviving free of major amputation at 12 months. These results suggest early safety and provide an initial assessment of the efficacy of the LimFlow pDVA System that supports the expansion of carefully executed studies to determine whether this is a viable option that can be used in this critically disadvantaged and growing patient population.

Two-year PAD-related health care costs in patients undergoing lower extremity endovascular revascularization: results from the LIBERTY 360° trial.

BACKGROUND: Multiple studies have demonstrated the high economic burden related to the management of lower extremity peripheral artery disease (PAD). This is the first study to examine long-term PAD-related costs among unselected patients undergoing endovascular intervention, and to investigate how clinical and anatomic factors impact cost outcomes over time. METHODS AND RESULTS: We performed a prospective health economic study alongside the LIBERTY 360° trial (ClinicalTrials.gov; identifier NCT01855412) - a prospective, multi-center study evaluating the long-term outcomes of endovascular revascularization to treat claudication or critical limb ischemia. Costs (2018) were calculated using a combination of standard "bottom-up" cost accounting methods (for index procedures), itemized hospital charges and department level cost-to-charge ratios (for non-procedural hospital resources), national Medicare Severity-Diagnosis Related Group-specific average reimbursements (for follow-up hospitalizations) and Medicare payments (for outpatient/chronic care). Methods for the analysis of censored cost data were used to adjust cost estimates for patients with incomplete follow-up. Independent predictors of cumulative 2-year costs were explored using generalized linear models. A total of 1,189 patients were included (500 Rutherford 2-3, 589 Rutherford 4-5, 100 Rutherford 6). Mean total costs associated with the index procedure hospitalization increased with Rutherford classification ($10,304, $11,418, and $19,403 for Rutherford 2-3, 4-5, and 6, respectively; p < 0.01 in all pairwise comparisons). Mean total 2-year follow-up costs were $11,416, $24,846, and $25,720 for Rutherford 2-3, 4-5, and 6, respectively (p < 0.001 comparing Rutherford 2-3 to the other 2 groups; p = 0.09 comparing Rutherford 4-5 and Rutherford 6). Key predictors of higher cumulative 2-year costs included female sex, pedal lesion location, severe lesion calcification, the presence of one or more chronic total occlusions, the number of wounds present on the target limb at baseline, and Rutherford classification. CONCLUSIONS: Among patients with symptomatic lower extremity PAD undergoing endovascular revascularization, initial treatment costs and total 2-year costs vary significantly according to clinical and lesion-level characteristics, as well as symptom burden.

Modern multidisciplinary team approach is crucial in treatment for critical limb threatening ischemia.

The aim of this study was to provide a brief overview of the history the multidisciplinary team approach, highlighting the benefit to the patient with critical limb threatening ischemia in relation to health care economics. Furthermore, we provided a description of the requisites and key components, showing how to build a multidisciplinary team.

Utilization Rates of Diagnostic and Therapeutic Vascular Procedures Among Patients Undergoing Lower Extremity Amputations in a Rural Community Hospital: A Clinicopathological Correlation.

BACKGROUND: Significant geographical variations exist in amputation rates and utilization of diagnostic and therapeutic vascular procedures before lower extremity amputations in the United States. The purpose of this study was to evaluate the rates of diagnostic and therapeutic vascular procedures in the year prior to amputation in a contemporary population and correlate with pathological findings of the amputation specimens. METHODS: A retrospective analysis was conducted of non-traumatic amputations from 2011 to 2017 at a rural community hospital. We reviewed the proportion of patients undergoing diagnostic (ankle brachial index with duplex ultrasound, computerized tomography angiogram and invasive angiogram) and therapeutic (endovascular and surgical revascularization) vascular procedures in the year prior to amputation. Prevalence of tissue viability and osteomyelitis were evaluated in all amputated specimens and atherosclerotic vascular disease (ASVD) was evaluated in major amputations. We also analyzed primary amputation rates among different subgroups. RESULTS: 698 patients were included with 248 (36%) major amputations and 450 (64%) minor amputations. Any diagnostic procedure was performed in 59% of the major amputations and 49% of the minor amputations (P = 0.01). Any therapeutic revascularization procedure was performed in 34% of the major amputations and 28% of the minor amputations (P = 0.08). The pathology of major amputation specimens revealed severe ASVD in 57% and mild-moderate ASVD in 27% of specimens. Tissue viability was significantly higher in major amputations (90% vs 30%, P = 0.04) and osteomyelitis was significantly higher in minor amputations (50% vs 14%, P = 0.03). Primary amputations were performed in 66% of major amputations, 72% of minor amputations, 81% with mild to moderate ASVD and 54% with severe ASVD. CONCLUSION: Diagnostic and therapeutic vascular procedures appear under-utilized for patients undergoing lower extremity amputations at a rural community hospital. ASVD rates and tissue viability imply that revascularization could be of significant benefit to avoid major amputation.

Three-Year Outcomes From the LIBERTY 360 Study of Endovascular Interventions for Peripheral Artery Disease Stratified by Rutherford Category.

PURPOSE: To report the 3-year results of the LIBERTY 360 study, which investigated outcomes of endovascular treatment of symptomatic peripheral artery disease (PAD). MATERIALS AND METHODS: The LIBERTY trial (ClinicalTrials.gov identifier NCT01855412) was a prospective, observational, core laboratory-assessed, multicenter study of endovascular interventions enrolling >1200 participants treated at 51 sites. Data from 1189 patients were stratified according to Rutherford category (RC) and analyzed [RC 2-3 (n=500), RC 4-5 (n=589), and RC 6 (n=100)]. The primary outcomes were major amputation of the target limb and all-cause death; secondary outcomes were target vessel revascularization (TVR) or target lesion revascularization (TLR); major adverse events (MAEs; death within 30 days, TVR or TLR, and major amputation); death or major amputation combined; and change in self-reported quality of life (QoL) measures (VascuQol-25). The Kaplan-Meier (KM) method was employed to estimate the outcomes; estimates are presented with the 95% confidence intervals (CI). Predictors of 3-year MAE, death, TVR, and major amputation were analyzed using Cox proportional hazard regression modeling. RESULTS: The 36-month KM survival rates were 86.0% in RC 2-3, 79.8% in RC 4-5, and 62.0% in RC 6 groups. The KM estimates of freedom from major amputation at 36 months were 98.5% in RC 2-3, 94.0% in RC 4-5, and 79.9% in RC 6. The 36-month KM estimates for freedom from TVR/TLR were 71.1% in RC 2-3, 64.2% in RC 4-5 and 61.9% in RC 6 groups. Patients with claudication at baseline were at lower risk for MAEs compared with RC 4-5 and RC 6 patients during the 36-month follow-up. Vascular QoL improved from baseline and persisted up to 36 months in all patients. CONCLUSION: Endovascular therapy is a viable treatment option for patients with symptomatic PAD, with sustained improved quality of life in both claudicants and patients with chronic limb-threatening ischemia. These results provide important point estimates for midterm outcomes after modern endovascular interventions for PAD.

Characteristics and Outcomes of Patients With Diabetes Mellitus Undergoing Peripheral Vascular Intervention for Infrainguinal Symptomatic Peripheral Artery Disease.

PURPOSE: Patients with diabetes mellitus (DM) are known to be at higher risk for peripheral artery disease (PAD), amputations, and major adverse cardiovascular events, though it is unclear whether they are at any higher risk for repeat intervention. LIBERTY 360 offered an opportunity to study a real-world cohort of patients who underwent distal superficial femoral artery endovascular revascularizations. We aimed to describe patients with DM, their outcomes following peripheral vascular intervention, and the effect of DM on outcomes in the LIBERTY 360 cohort. METHODS: LIBERTY 360 is a prospective, multi-center, non-randomized, mono-industry funded observational study of patients undergoing endovascular revascularization. Outcomes included 30-day and 1-year all-cause mortality, major amputation, target vessel/lesion revascularization, and a composite of those events. A multivariable regression model including DM was constructed to examine the effect of DM on outcomes. Multivariable survival estimates were made using Cox proportional hazards models. RESULTS: A total of 1,204 patients were enrolled, of whom 727 had DM (60.4%). Patients with DM had significantly more comorbidities and a third required insulin for DM management. Patients with DM had more severe disease based on Rutherford classification at baseline. After adjusting for comorbidities and disease severity, DM patients had more frequent major amputations at 1 year (5.2% versus 1.2%; HR 2.71, 95%CI 1.05-6.98, p = 0.040). The 1-year rates of all-cause mortality and target vessel/lesion revascularization were not significantly higher for patients with DM. CONCLUSIONS: Diabetes mellitus was associated with increased major amputations at 1 year following endovascular revascularization after accounting for demographics, comorbidities, and PAD-related characteristics. Further research is needed to determine which aspects of PAD and DM are most strongly associated with poor outcomes following lower extremity revascularization.

The impact of chronic kidney disease on outcomes following peripheral vascular intervention.

BACKGROUND: Patients with chronic kidney disease (CKD) have worsened clinical outcomes following percutaneous coronary intervention; however, limited evidence exists in patients undergoing peripheral vascular intervention (PVI). PURPOSE: We aimed to assess the effect of CKD on outcomes following PVI for symptomatic peripheral artery disease. METHODS: Using patients from the LIBERTY 360 study, we compared the rates of 30 day and 1 year major adverse vascular events (MAVE), a composite of all-cause mortality, major amputation, and target vessel/lesion revascularization, between patients with and without CKD (estimated glomular filtration rate less than 60) following PVI. Multivariable adjustment was performed to assess for independent association between CKD and outcomes. RESULTS: Among 1189 patients enrolled, 378 patients (31.8%) had CKD. At 1 year, patients with CKD had higher rates of MAVE (34.6% vs 25.6%), all-cause mortality (11.9% vs 5.5%), and major amputation (5.9% vs 2.6%) when compared with patients without CKD (all P < .05). After adjustment, patients with CKD had higher risks of 1-year MAVE (HR 1.30, 95% CI 1.04-1.64; P = .023) and all-cause mortality (HR 1.88, 95% CI 1.22-2.91; P = .005) when compared with patients without CKD. There was no statistically significant difference in risk of major amputations (HR 1.70, 95% CI 0.91-3.17; P = .094). CONCLUSIONS: Despite high procedural success and low amputation rates, patients with CKD remain at greater risk for MAVE and all-cause mortality after PVI. Further research is needed to determine treatment strategies to mitigate substantial mortality risk in this vulnerable population.

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.