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The purpose of this study was to review the current literature of intravascular ultrasound (IVUS) use in real world cohorts inclusive of chronic limb threatening ischemia (CLTI) patients and compare the outcomes to patients imaged by angiography alone.The systematic review was registered in Research Registry. A literature search was performed across 4 databases: PubMed, Medline/Embase, Cochrane Review, and Web of Science for eligible comparative studies. The primary outcomes examined were clinically driven target lesion revascularization (CD-TLR), amputation (including minor below the ankle and major above the ankle), all-cause mortality, limb salvage and mean balloon dilation. A random effects model was used when pooling outcomes to account for heterogeneity. Publication bias was determined using eggers test and illustrated on a funnel plot.Six studies were included in this review, with a total of 1883 subjects with Rutherford 1-6. Among the 1883 subjects, 940 had Rutherford 4-6. IVUS was used in 1294 subjects and angiography alone was used in 589 subjects. Pooled analysis determined no significant association in IVUS + angiography with CD-TLR (O.R = 1.43 [CI: 0.80, 2.58]), all-cause amputation (O.R = 0.63 [CI: 0.34, 1.17]), and all-cause mortality (O.R = 0.63 [CI: 0.34, 1.17]). Sub analysis of subjects with CLTI, Rutherford classes 4-6 showed an association between IVUS + angiography use with limb salvage at 1 year, O.R = 2.22 [1.24, 3.97].The use of IVUS + angiography compared to angiography alone showed larger reference vessel diameter in both all-inclusive Rutherford classifications and the CLTI subset. The use of IVUS + angiography compared to angiography alone showed no difference in CD-TLR at 12 months, lower extremity amputation, and all-cause mortality for Rutherford 1-6. The use of IVUS + angiography compared to angiography alone in the CLTI subset analysis improved limb salvage. [ABSTRACT FROM AUTHOR]

We assessed the clinical outcomes of patients with critical limb-threatening ischemia (CLTI) who underwent interwoven nitinol stent (Supera) implantation for significant stenoses of the femoropopliteal segment. In this retrospective cohort study, 116 consecutive patients with CLTI who were treated with Supera stents between September 2015 and March 2020 were included in this analysis. Primary endpoint analysis was completed for amputation-free survival, target lesion revascularization (TLR), and mortality. After a mean follow-up time of 3.4 years, 21 (18%) patients had undergone amputations, 3 (2.6%) died, and, overall, the amputation-free survival rate was 81%. TLR occurred in 21 (18%) patients, resulting in the freedom from target lesion revascularization of 82%. The average Wagner score for all patients was 2.8 ± 1.1. A subgroup analysis of 57 patients revealed a median ulcer size of 3.0 cm2 [1.65, 9.0], with complete healing for 45 patients by 20 months. The Wagner score of this subgroup decreased by an average of 3.4 ±.9 points. Supera stents can be used together with other endovascular therapies and are a safe and effective treatment modality for CLTI. [ABSTRACT FROM AUTHOR]

Objective: To compare the safety and efficacy between the SpiderFX EPD and Emboshield NAV6 filter in the collection of embolic debris created from lower limb atherectomy procedures in patients with PAD.Materials and Methods: Between January 2014 and October 2015, 507 patients with symptomatic peripheral artery disease were treated with directional atherectomy (SilverHawk), rotational atherectomy (JetStream), or laser atherectomy (Turbo Elite) based on operator discretion. Emboshield NAV6 (n = 161) and SpiderFX (n = 346) embolic protection devices were used with each of the 3 atherectomy devices. The primary study endpoint was 30-day freedom from major adverse events (MAEs). An MAE was defined as death, MI, TVR, thrombosis, dissection, distal embolization, perforation at the level of the filter, and unplanned amputation. A descriptive comparison of the MAE rates between Emboshield NAV6 and SpiderFX embolic protection devices was conducted.Results: The freedom from major adverse event (MAE) rate was 92.0% (CI: 86.7%, 95.7%) in patients who received an Emboshield NAV6 filter compared to 91.6% (CI: 88.2%, 94.3%) in patients who received the SpiderFX filter (p=0.434). The lower limit of 86.7% freedom from major adverse event rate in the Emboshield NAV6 group was above the performance goal of 83% (p < 0.0008).Conclusions: There were no significant clinical outcome differences between Emboshield NAV6 and SpiderFX EPD filters in the treatment of lower extremities. This evaluation indicates the safety and efficacy to use either filter device to treat PAD patients with lower extremity lesions. [ABSTRACT FROM AUTHOR]

New York City was one of the epicenters of the COVID-19 pandemic. The management of peripheral artery disease (PAD) during this time has been a major challenge for health care systems and medical personnel. This document is based on the experiences of experts from various medical fields involved in the treatment of patients with PAD practicing in hospitals across New York City during the outbreak. The recommendations are based on certain aspects including the COVID-19 infection status as well as the clinical PAD presentation of the patient. Our case-based algorithm aims at guiding the treatment of patients with PAD during the pandemic in a safe and efficient way. [ABSTRACT FROM AUTHOR]

Objectives: To assess 24-month outcome differences based on sex in symptomatic femoro-popliteal arterial disease of patients treated with drug-coated balloon (DCB). Background: Peripheral artery disease affects over 12 million people in the United States. Drug-coated balloons have shown to be effective in treating patients with symptomatic femoropopliteal arterial occlusive disease. Debate remains regarding its safety and efficacy in female gender. We investigated the differential treatment effect between genders. Methods: Patients (93 females and 102 males) with symptomatic femoropopliteal arterial disease treated with DCB from November 2014 to November 2015 were included in this retrospective study. We compared the resting ankle-brachial indices (ABIs) and peak systolic velocities (PSVs) by arterial duplex between the male and female patients at 6, 12, and 24 months postintervention. Results: Females had significantly smaller vessels (4.70 ± 0.9, P =.02) and higher body mass index (BMI; 30.0 ± 3.7, P =.002) than males. Females had significantly decreased ABI and PSV at the 6-month (ABI: 0.90 ± 0.15, P =.05 and PSV: 188.30 ± 103.1, P =.02), 12-month (ABI: 0.86 ± 0.15, P <.0001 and PSV: 219.10 ± 100.10, P =.001), and at 24-month (ABI: 0.84 ± 0.2, P =.0001 and PSV: 251.0 ± 135.9, P <.0001) intervals when compared to males. Females had increased clinically driven target lesion revascularization (TLR) at 6 months (females = 8 vs males = 4, P =.22), 12 months (females = 12 vs males = 4, P =.02), and 24 months (females = 14 vs males = 6, P =.03). In simple logistic regression analysis, BMI, age, reference vessel diameter (RVD), and gender were strongly associated with target lesion restenosis. The final model included the above and it produced the following odds ratios (ORs): BMI (OR = 1.07, 95% confidence interval [CI]: 0.98-1.2), age (OR: 1.0, CI: 0.96-1.03), RVD (OR: 1.6, CI: 1.02-2.4), and gender (OR: 3.5, CI: 1.6-7.8). Conclusion: Females treated with DCBs have significantly decreased ABI, PSVs, and an increased rate of TLR than their male counterparts. [ABSTRACT FROM AUTHOR]

Diabetes mellitus (DM) and chronic kidney disease (CKD) separately are known to facilitate the progression of medial arterial calcification (MAC) in patients with symptomatic peripheral artery disease (PAD), but their combined effect on MAC and associated mediators of calcification is not well studied. The association of MAC and calcification inducer bone morphogenetic protein (BMP-2) and inhibitor fetuin-A, with PAD, is well known. Our aim was to investigate the association of MAC with alterations in BMP-2 and fetuin-A protein expression in patients with PAD with DM and/or CKD. Peripheral artery plaques (50) collected during directional atherectomy from symptomatic patients with PAD were evaluated, grouped into no-DM/no-CKD (n = 14), DM alone (n = 10), CKD alone (n = 12), and DM+CKD (n = 14). MAC density was evaluated using hematoxylin and eosin, and alizarin red stain. Analysis of inflammation, neovascularization, BMP-2 and fetuin-A protein density was performed by immunohistochemistry. MAC density, inflammation grade and neovessel content were significantly higher in DM+CKD versus no-DM/no-CKD and CKD (p < 0.01). BMP-2 protein density was significantly higher in DM+CKD versus all other groups (p < 0.01), whereas fetuin-A protein density was significantly lower in DM+CKD versus all other groups (p < 0.001). The combined presence of DM+CKD may be associated with MAC severity in PAD plaques more so than DM or CKD alone, as illustrated in this study, where levels of calcification mediators BMP-2 and fetuin-A protein were related most robustly to DM+CKD. Further understanding of mechanisms involved in mediating calcification and their association with DM and CKD may be useful in improving management and developing therapeutic interventions. [ABSTRACT FROM AUTHOR]

No adequately powered studies exist to compare major clinical outcomes after endovascular therapy (EVT) with stent implantation vs bypass surgery (BSx) for symptomatic femoropopliteal peripheral artery disease. This study sought to perform a pooled analysis of individual patient data from all randomized controlled trials comparing EVT vs BSx. Principal investigators of 5 of 6 available randomized controlled trials agreed to pool individual patient data. The primary endpoint was major adverse limb events, a composite of all-cause death, major amputation, or target limb reintervention. Secondary endpoints included amputation-free survival, individual major adverse limb event components, and primary patency. Early complications were bleeding, infection, or all-cause death within 30 days. A total of 639 patients were analyzed with a mean age of 68.1 ± 9.1 years and 29.0% women. Baseline characteristics were comparable between groups. At 2 years, there were no significant differences between patients who received EVT and those who received BSx regarding major adverse limb events (40.1% vs 36.4%; log-rank P = 0.447; adjusted HR [aHR]: 1.04; 95% CI: 0.80-1.36), amputation-free survival (88.1% vs 90.0%; log-rank P = 0.455; aHR for death or amputation: 1.04; 95% CI: 0.63-1.71) and the other secondary endpoints except for primary patency, which was lower in patients who received EVT vs those who received BSx (51.2% vs 61.3%; log-rank P = 0.024; aHR for loss of primary patency: 1.31; 95% CI: 1.02-1.69). EVT was associated with significantly lower rates of early complications (6.8% vs 22.6%; P < 0.001) and shorter hospital stay (3.1 ± 4.2 days vs 7.4 ± 4.9 days; P < 0.001). These findings further support the efficacy and safety of EVT as an alternative to BSx in patients with symptomatic femoropopliteal peripheral artery disease. [Display omitted] [ABSTRACT FROM AUTHOR]

Background: Drug-coated balloons (DCB) are frequently used to treat femoropopliteal artery disease. However, patency loss occurs in ≥10% of patients within 12 months posttreatment with poor understanding of the underlying mechanisms.Objectives: The authors sought to investigate the determinants of DCB failure in femoropopliteal disease.Methods: Data from randomized clinical trials (IN.PACT SFA, MDT-2113 SFA Japan) and 2 prespecified imaging cohorts of the IN.PACT Global Clinical Study were included. Influential procedural characteristics were evaluated by an independent angiographic core laboratory. The primary endpoint was DCB failure (patency loss during follow-up). Additional endpoints were binary restenosis and clinically driven target lesion revascularization. Multivariable analyses evaluated the clinical, anatomical, and procedural predictors of DCB failure.Results: Included were 557 participants with single lesions and 12-month core laboratory-adjudicated duplex ultrasonography. Key clinical characteristics were as follows: mean age 68.8 years, 67.5% male, 87.6% with hypertension, 76.9% with hyperlipidemia, 40.5% with diabetes mellitus, 90.5% in Rutherford Classification Category (RCC) 2 to 3, and 9.5% in RCC 4 to 5. Average length and reference vessel diameter (RVD) were 16.37 cm and 4.66 mm, respectively; 49.7% of lesions were totally occluded. In multivariable analysis, only residual stenosis >30% was associated with patency loss, whereas residual stenosis >30% and smaller preprocedure RVD were associated with increased binary restenosis risk. RCC >3 and residual stenosis >30% were associated with increased 12-month clinically driven target lesion revascularization risk.Conclusions: Patency loss after DCB treatment was influenced by procedural and clinical factors. Residual stenosis >30%, smaller preprocedure RVD, and higher RCC may be considered predictors of increased risk of DCB failure and its components in femoropopliteal artery disease. (Randomized Trial of IN.PACT Admiral® Drug Coated Balloon vs Standard PTA for the Treatment of SFA and Proximal Popliteal Arterial Disease [INPACT SFA I]; NCT01175850; IN.PACT Admiral Drug-Coated Balloon vs. Standard Balloon Angioplasty for the Treatment of Superficial Femoral Artery [SFA] and Proximal Popliteal Artery [PPA] [INPACT SFA II]; NCT01566461; MDT-2113 Drug-Eluting Balloon vs. Standard PTA for the Treatment of Atherosclerotic Lesions in the Superficial Femoral Artery and/or Proximal Popliteal Artery [MDT-2113 SFA]; NCT01947478; IN.PACT Global Clinical Study; NCT01609296). [ABSTRACT FROM AUTHOR]