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Purpose: To evaluate the performance of peripheral intravascular lithotripsy (IVL) in a real-world setting during endovascular treatment of multilevel calcified peripheral artery disease (PAD). Materials and Methods: The Disrupt PAD III Observational Study (ClinicalTrials.gov identifier NCT02923193) is a prospective, nonrandomized, multicenter, single-arm observational study assessing the acute safety and effectiveness of the Shockwave Peripheral IVL System for the treatment of calcified, stenotic lower limb arteries. Patients were eligible if they had claudication or chronic limb-threatening ischemia and moderate or severe arterial calcification. Between November 2017 and August 2018, 200 patients (mean age 72.5±8.7 years; 148 men) were enrolled across 18 sites and followed through hospital discharge. Results: In the 220 target lesions, IVL was more commonly used in combination with other balloon-based technologies (53.8%) and less often with concomitant atherectomy or stenting (19.8% and 29.9%, respectively). There was a 3.4-mm average acute gain at the end of procedure; the final mean residual stenosis was 23.6%. Angiographic complications were rare, with only 2 type D dissections and a single perforation following drug-coated balloon inflation (unrelated to the IVL procedure). There was no abrupt closure, distal embolization, no reflow, or thrombotic event. Conclusion: Use of peripheral IVL to treat severely calcified, stenotic PAD in a real-world study demonstrated low residual stenosis, high acute gain, and a low rate of complications despite the complexity of disease. [ABSTRACT FROM AUTHOR]

Purpose: To report the clinical effect of a drug-eluting stent on femoropopliteal occlusive disease in patients with long lesions. Materials and Methods: The global IMPERIAL Long Lesion substudy (ClinicalTrials.gov identifier NCT02574481) is a prospective, single-arm, multicenter trial of the Eluvia Drug-Eluting Vascular Stent for treating femoropopliteal lesions >140 mm and ≤190 mm in length. Fifty patients (mean age 68.2 years; 32 men) with long lesions (mean length 162.8±34.7 mm) were enrolled; 20 patients had diabetes. Fourteen of the lesions were severely calcified and 16 were occluded. Primary patency (duplex ultrasound peak systolic velocity ratio ≤2.4 in the absence of clinically-driven target lesion revascularization or bypass of the target lesion) and major adverse events [30-day all-cause death and 1-year target limb major amputation or target lesion revascularization (TLR)] were assessed at 12 months. Results: At 12 months, no deaths, target limb amputations, or stent thrombosis had occurred. The Kaplan-Meier estimate of primary patency was 91.0% (95% CI 82.5% to 99.6%). The MAE-free rate at 12 months was 93.5% due to 3 clinically-driven TLRs. The corresponding Kaplan-Meier estimate of freedom from TLR was 93.9% (95% CI 87.2% to 100%). Conclusion: The IMPERIAL Long Lesion substudy demonstrated excellent patency and safety through 1 year among patients with long femoropopliteal occlusive disease treated with the Eluvia stent. [ABSTRACT FROM AUTHOR]

Background Bare-metal stent (BMS) scaffolding of superficial femoral artery occlusive lesions has been associated with high rates of late clinical failure. Maintaining the patency of recanalized arterial segments was the main issue behind the concept of leaving nothing behind to be evolved and percutaneous balloon angioplasty becomes the preferred option for endovascular therapy. Drug-eluting balloons (DEBs) have shown to be an effective alternative to BMS for patients with de novo complex superficial femoral occlusive disease. Aims The aim was to compare the outcome of DEB versus BMS in treating complex chronic total occlusion of superficial femoral and proximal popliteal artery in patients with disabling claudication and critical limb ischemia regarding technical success, primary patency, clinically driven target lesion revascularization (cd-TLR), and limb salvage rate. Materials and methods The current study is a multicenter, prospective, randomized study. Ninety patients (110 limbs) complaining of disabling and critical limb ischemia due to complex femoropopliteal occlusive lesions were randomly allocated into two groups according to the intervention method performed. Group A included 48 patients (57 limbs) who were submitted for treatment with paclitaxel DEBs and group B included 42 patients (53 limbs) submitted for treatment with BMS. The follow-up period was for 1, 6, and 12 months. Statistical analysis was performed by using the IBM SPSS Statistics version 22 for Windows Program Package (SPSS Inc., Chicago, IL, USA). Results BMSs seem to have lower patency and higher cd-TLR rates compared with patients who received paclitaxel drug-coated balloons but was not statistically significant. The primary patency rates were 100, 96, and 86.2% at 1, 6, and 12 months' respectively' in the DEB group versus 100, 89.8, and 77.6% at 1, 6, and 12 months, respectively, in the BMS group. Clinically driven TLR rates were 2 and 7.8% at 6 and 12 months, respectively, in the DEB group versus 6.1 and 14.2% at 6 and 12 months, respectively, in the BMS group. Conclusion Percutaneous therapy for Trans atlantic inter-societies consensus (TASC) C and D femoropopliteal lesion using DEB or BMS is safe and effective with a high patency rate of 1 year. Paclitaxel drug-eluting balloons seem to have a promising role in the prevention of restenosis and recurrence of peripheral arterial occlusive disease. However, stents are still playing important bailout role in the treatment of residual stenosis and dissection. Further follow-up is essential to obtain and document long-term outcome of different percutaneous therapy for complex and long superficial femoral artery (SFA) lesions. [ABSTRACT FROM AUTHOR]

Purpose: To evaluate the safety and effectiveness of the TIGRIS stent for lesions up to 24 cm in the superficial femoral and proximal popliteal arteries (SFA/PPA).Methods: This prospective, multicenter, randomized study enrolled 274 subjects at 36 sites in the United States and Europe. Subjects were randomly assigned in a 3:1 ratio to treatment with the TIGRIS stent (n=197; mean age 66.7±9.28 years; 141 men) or LifeStent (n=70; mean age 67.9±8.87 years; 49 men). The primary safety endpoint was 30-day freedom from major adverse events (MAE). The primary efficacy endpoint was primary patency at 12 months. Secondary endpoints included target lesion revascularization (TLR) and stent fracture. Clinical success and quality of life were also assessed.Results: Mean lesion length (107.6 vs 117.9 mm, p=0.29), procedure success (99.5% vs 97.1%, p=0.17), and freedom from MAE (99.5% vs 100%, p>0.99) were similar for the TIGRIS and control groups, respectively. Likewise, there was no difference in primary patency at 12 months (60.6% vs 63.2%, p=0.73) or 24 months (56.3% vs 50.2%, p=0.60) or in TLR at the same time points (76.6% vs 80.6%, p=0.49; 70.5% vs 67.2%, p=0.85). There were no differences in the changes in Rutherford category or the ankle/brachial index through 24 months. The rate of stent fracture was lower for TIGRIS compared with LifeStent (0% vs 32.7%, p<0.001).Conclusion: The TIGRIS stent and LifeStent were similarly effective for the treatment of lesions in the SFA and PPA. The high flexibility and zero fracture rate associated with the TIGRIS stent make this device favorable for use in high-flexion arteries. [ABSTRACT FROM AUTHOR]

Purpose: To report the effectiveness of directional atherectomy for the treatment of popliteal artery occlusive disease.Methods: This subset of the prospective, multicenter, single-arm DEFINITIVE LE trial included 158 patients (mean age 72.0±10.9 years; 82 men) who underwent directional atherectomy in 162 popliteal artery lesions between 2009 and 2011. Forty-eight (30.4%) patients were suffering from critical limb ischemia (CLI). The mean lesion length was 5.8±3.9 cm; 38 (23.5%) arteries were occluded. The primary outcome measure for patients with intermittent claudication (IC) was duplex ultrasound-defined primary patency at 1 year; the outcome for subjects with CLI was freedom from major amputation of the target limb at 1 year. Outcomes and adverse events were independently assessed.Results: Procedure success (≤30% residual stenosis) was achieved in 84.4% of treated lesions; adjunctive stenting was required in 6 (3.7%) of the 162 lesions. The 1-year primary patency rate was 75.0% (IC patients 78.2% and CLI patients 67.5%, p=0.118). The freedom from major amputation in both cohorts was 100%. In both IC and CLI patients, significant improvements were demonstrated at 1 year in the Rutherford category, walking distance, and quality of life in comparison to baseline.Conclusion: This study indicates that directional atherectomy in popliteal arteries leads to favorable technical and clinical results at 1 year for claudicant as well as CLI patients. [ABSTRACT FROM AUTHOR]

Purpose: To evaluate the safety and efficacy of a novel optical coherence tomography (OCT)-guided atherectomy catheter in treating patients with symptomatic femoropopliteal disease.Methods: The VISION trial ( ClinicalTrials.gov identifier NCT01937351) was a single-arm, multicenter, global investigational device exemption study enrolling 158 subjects (mean age 67.2±10.5 years; 87 men) across 20 participating sites. In this cohort, 198 lesions were treated with an average length of 53±40 mm using the Pantheris catheter alone or Pantheris + adjunctive therapy. The primary safety endpoint was the composite of major adverse events (MAEs) through 6 months (objective performance goal 43.2%). Technical success (primary efficacy outcome) was defined as the percent of target lesions with a residual diameter stenosis ≤50% after treatment with the Pantheris device alone (objective performance goal 87.0%). Procedural success was defined as reduction in stenosis to ≤30% after Pantheris ± adjunctive therapy. Tissue specimens retrieved from each treated lesion were histologically analyzed to evaluate the accuracy and precision of OCT image guidance.Results: The primary efficacy outcome was achieved in 192 (97.0%) of the 198 lesions treated with the Pantheris catheter. Across all lesions, mean diameter stenosis was reduced from 78.7%±15.1% at baseline to 30.3%±11.8% after Pantheris alone (p<0.001) and to 22.4%±9.9% after Pantheris ± adjunctive therapy (p<0.001). Of the 198 target lesions, 104 (52.5%) were treated with the Pantheris alone, 84 (42.4%) were treated with Pantheris + adjunctive angioplasty, and 10 (5.1%) with Pantheris + angioplasty + stenting. The composite MAE outcome through 6 months occurred in 25 (16.6%) of 151 subjects. There were no clinically significant perforations, 1 (0.5%) catheter-related dissection, 4 (2%) embolic events, and a 6.4% clinically driven target lesion revascularization rate at 6 months. The 40-lesion chronic total occlusion (CTO) subset (mean lesion length 82±38 mm) achieved a similar significant reduction in stenosis to 35.5%±13.6% after Pantheris alone (p<0.001). Histological analysis of atherectomy specimens confirmed <1% adventitia in 82.1% of the samples, highlighting the precision of OCT guidance. Characterization of the OCT-guided lesions revealed evidence of an underestimation of disease burden when using fluoroscopy.Conclusion: OCT-guided atherectomy for femoropopliteal disease is safe and effective. Additionally, the precision afforded by OCT guidance leads to greater removal of plaque during atherectomy while sparing the adventitia. [ABSTRACT FROM AUTHOR]

Background Patients with severe-stage chronic kidney disease (CKD) were excluded from femoropopliteal disease trials evaluating drug-coated balloons (DCBs) and drug-eluting stents (DESs) versus plain balloon angioplasty (POBA) and bare metal stents (BMSs). We examined the interaction between CKD status and device type for the association with 24-month all-cause mortality and major amputation risk. Methods and Results We studied patients undergoing femoropopliteal interventions (September 2016-December 2018) from Medicare-linked VQI (Vascular Quality Initiative) registry data. We compared outcomes for: (1) early-stage CKD (stages 1-3) receiving DCB/DES, (2) early-stage CKD receiving POBA/BMS, (3) severe-stage (4 and 5) CKD receiving DCB/DES, and (4) severe-stage CKD receiving POBA/BMS. We studied 8799 patients (early-stage CKD: 94%; severe-stage: 6%). DCB/DES use was 57% versus 51% in patients with early-stage versus severe-stage CKD. Twenty-four-month mortality risk for patients with early-stage CKD receiving DCB/DES (reference) was 21% versus 28% (hazard ratio [HR], 1.47 [95% CI, 1.31-1.65]) for those receiving POBA/BMS; patients with severe-stage CKD: those receiving DCB/DES had a 49% (HR, 2.61 [95% CI, 2.06-3.31]) mortality risk versus 52% (HR, 3.64 [95% CI, 2.91-4.55]) for those receiving POBA/BMS (interaction P <0.001). Adjusted analyses attenuated these results. For severe-stage CKD, DCB/DES versus POBA/BMS mortality risk was not significant at 24 months (post hoc comparison P =0.06) but was higher for the POBA/BMS group at 18 months (post hoc P <0.05). Patients with early-stage CKD receiving DCB/DES had the lowest 24-month amputation risk (6%), followed by 11% for early-stage CKD-POBA/BMS, 15% for severe-stage CKD-DCB/DES, and 16% for severe-stage CKD-POBA/BMS (interaction P <0.001). DCB/DES versus POBA/BMS amputation rates in patients with severe-stage CKD did not differ (post hoc P =0.820). Conclusions DCB/DES versus POBA/BMS use in patients with severe-stage CKD was associated with lower mortality and no difference in amputation outcomes.

Purpose: To evaluate the outcomes and stent-device interaction of the JetStream atherectomy device in the treatment of in-stent restenosis (ISR) of the femoropopliteal segment. Methods: The JetStream XC atherectomy device, a rotational cutter with aspiration capacity, was evaluated in a prospective cohort of 29 patients (mean age 69.9 ± 11.7 years; 11 men) with femoropopliteal ISR in 32 limbs (ClinicalTrials.gov identifier NCT01722877). Lesion length was 17.4 ± 13.1 cm. The primary effectiveness outcome was acute success (≤ 30% residual narrowing with no serious adverse events). The primary safety endpoint was major adverse events. Secondary endpoints included clinically driven target lesion revascularization (TLR) at 6 months and 1 year and loss of stent integrity as assessed by an angiographic core laboratory. Results: Treated length was 19.5 ± 12.9 cm. Acute success was obtained in 29/32 (91%) limbs. Acute device success (<50% residual narrowing after atherectomy alone) was 76% (22/29). Adjunctive balloon angioplasty was performed in all cases at a mean pressure of 11.6 ± 3.3 atm. Embolic filter protection was used in 16 (50%) of 32 limbs. Macrodebris was noted in 2 (12%) of 16 filters. Distal embolization requiring treatment occurred in 3/32 (9.4%) limbs (2 with no filter). Other non-procedure-related adverse events were 1 (3%) death (nonvascular) and 1 (3%) case of major bleeding. There were no new stent fractures or deformities (n=24) postatherectomy. Follow-up was completed on 27 patients (29 limbs) at 6 and 12 months. TLR at these time points occurred in 4/29 (14%) and 12/29 (41%) patients. Patency (duplex-derived peak systolic velocity ratio <2.4) was 72% at 6 months. Conclusion: JetStream atherectomy using the XC device has favorable acute results in treating femoropopliteal ISR with high procedure success, no device-stent interaction, and favorably low TLR rates. A multicenter trial is needed to confirm these results. [ABSTRACT FROM AUTHOR]

Introduction: This study aimed to determine the incidence, management, and outcomes of popliteal artery injury, popliteal vein injury, and concomitant popliteal artery injury and vein injury. Methods: A retrospective analysis was completed using the 2000-2010 Nationwide Inpatient Sample utilizing International Classification of Diseases-9 codes to select patients with isolated popliteal artery injury (904.41), isolated popliteal vein injury (904.42), and isolated concomitant popliteal artery and vein injury (958.92). Variables included demographics, procedure type, and outcome during hospital course. Statistical analysis was with chi-square, Fisher exact test, and multivariate analysis. Results: A total of 2216 patients presented with injury to the popliteal system; 71% (1568) presented with isolated popliteal artery injury, 14% (306) with isolated popliteal vein injury, and 15% (342) with concomitant popliteal artery and vein injury. Amputation was significantly increased in popliteal artery injury and concomitant popliteal artery and vein injury (P < 0.001) as compared to popliteal vein injury. Ligation of the vein was more common in concomitant popliteal artery and vein injury when compared to popliteal vein injury (P < 0.05). The rate of amputation was 9.8% for popliteal artery injury, significantly greater than for popliteal vein injury (0.7%, P < 0.001) but not different than for concomitant popliteal artery and vein injury (8.2%, P = NS). Conclusion: Evidence-based management of popliteal vasculature may increase rates of limb salvage. Within the limitations of the data set used, conclusions appear to be that patients with popliteal vein injury or concomitant popliteal artery and vein injury may be managed with vein ligation without increased amputation rates as compared to popliteal artery injury. [ABSTRACT FROM AUTHOR]

Introduction: The aim of this study was to characterize national characteristics of patients who have a total knee replacement complicated by popliteal artery injury by incidence and patient demographics.Methods: All patients with ICD-9 confirmed total knee replacement who had an iatrogenic popliteal artery injury were included from the national in-patient sample from 1998 to 2011. Age, gender and race, procedure type, time to popliteal artery injury, limb outcome, length of stay and hospital inpatient charges were reported.Results: A total of 1,297,369 patients underwent a total knee replacement of which 43 were complicated by popliteal artery injury (0.003%); 93% had osteoarthritis as their primary diagnosis. The mean age was 61.7 ± 12.3 years. In all, 96% of patients had their popliteal injuries detected intra-operatively or on the day of total knee replacement surgery. The majority of these patients either received stent placement (44%) or peripheral bypass (30%) as their treatment modality for popliteal artery injury. There were no amputations or deaths in this cohort. The median hospital charges for this group were $27,570 (2014 USD).Conclusion: The national incidence of iatrogenic popliteal artery injury in patients undergoing TKR is 0.003%. There were no amputations in our study population and 96% of patients had their injury detected intra-operative or immediately post-operatively. [ABSTRACT FROM AUTHOR]

Objective: Drug-coated balloons (DCB) and drug-eluting stents (DES) have been rapidly adopted for femoropopliteal endovascular interventions due to their favorable patency rates. It is unclear whether choice of using drug coated devices versus bare metal stents (BMS) or plain balloon angioplasty (POBA) as primary treatment in femoropopliteal disease is mostly associated with patient-level factors, safety concerns, or by operator preferences. This study sought to evaluate factors associated with their use in a contemporary dataset., Methods: All femoropopliteal lesions treated with endovascular interventions between 2016 and 2019 from the Vascular Quality Initiative registry were included. For each procedure, a primary treatment was identified based on the following hierarchy: DES > DCB > BMS > POBA. A hierarchical logistic regression model predicting DCB or DES use included patient-level characteristics, key events (period after Centers for Medicare and Medicaid Services reimbursement change, January 2018 [vs before] and period after Katsanos meta-analysis December 2018 [vs before]), and random effects for site and operator. Operator-level variability for DCB and DES use was summarized with an adjusted median odds ratio (MOR)., Results: A total of 57,753 femoropopliteal endovascular procedures were included. Poor functional status (odds ratio [OR], 0.92; 95% confidence interval [CI], 0.90-0.94), prior anticoagulant use (OR, 0.92; 95% CI, 0.87-0.97), higher Rutherford classification (OR, 0.86; 95% CI, 0.84-0.88), chronic kidney disease stage 4 or 5 (OR, 0.92; 95% CI, 0.86-0.98), and the period after the Katsanos meta-analysis publication (OR, 0.3; 95% CI, 0.29-0.32) were associated with a lower odds of DCB or DES use; whereas female sex (OR, 1.12; 95% CI,1.08-1.17), prior lesion treatment (OR, 1.17; 95% CI, 1.11-1.22), diabetes (OR, 1.07; 95% CI, 1.02-1.12), Trans-Atlantic Inter-Society Consensus class B (OR, 1.16; 95% CI, 1.09-1.24) and C (OR, 1.2; 95% CI, 1.12-1.28), and the period after the Centers for Medicare and Medicaid Services reimbursement change (OR, 1.08; 95% CI, 1.03-1.14) were associated with a higher odds of DCB or DES use. Significant variability in use was found across operators (adjusted MOR, 2.70; 95% CI, 2.55-2.85) and centers (adjusted MOR, 2.89; 95% CI, 2.50-3.27)., Conclusions: DCB or DES use in femoropopliteal disease demonstrates wide variability across operators and is linked strongly with external factors, followed by anatomic lesion characteristics and a history of previous interventions. Future work needs to focus on tailoring DCB or DES use to patient and lesion characteristics and to develop appropriate use guidelines integrating these factors., (Copyright © 2022 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.)

Introduction: The 6-hour threshold to revascularization of an ischemic limb is ubiquitous in the trauma literature, however, contemporary evidence suggests that this threshold should be less. This study aims to characterize the relationship between the duration of limb ischemia and successful limb salvage following lower extremity arterial trauma., Methods: This is a cohort study of the United States and UK military service members injured while serving in Iraq or Afghanistan between 2003 and 2013. Consecutive patients who sustained iliac, femoral, or popliteal artery injuries, and underwent surgery to attempt revascularization, were included. The association between limb outcome and the duration of limb ischemia was assessed using the Kaplan-Meier method., Results: One hundred twenty-two patients (129 limbs) who sustained iliac (2.3%), femoral (56.6%), and popliteal (41.1%) arterial injuries were included. Overall, 87 limbs (67.4%) were successfully salvaged. The probability of limb salvage was 86.0% when ischemia was ≤1 hour; 68.3% when between 1 and 3 hours; 56.3% when between 3 and 6 hours; and 6.7% when >6 hours ( P <0.0001). Shock more than doubled the risk of failed limb salvage [hazard ratio=2.42 (95% confidence interval: 1.27-4.62)]., Conclusions: Limb salvage is critically dependent on the duration of ischemia with a 10% reduction in the probability of successful limb salvage for every hour delay to revascularization. The presence of shock significantly worsens this relationship. Military trauma systems should prioritize rapid hemorrhage control and early limb revascularization within 1 hour of injury., Competing Interests: The authors report no conflicts of interest., (Copyright © 2022 Wolters Kluwer Health, Inc. All rights reserved.)

Purpose: To study, from a U.S. payer's perspective, the economic consequences of drug-coated balloon (DCB) versus standard percutaneous transluminal angioplasty (PTA) use for the treatment of stenotic lesions in dysfunctional hemodialysis arteriovenous fistulae., Materials and Methods: Cost differences between DCBs and PTA at year 1 and beyond were calculated via 2 methods. The first approach used the mean absolute number of trial-observed access circuit reinterventions through 12 months (0.65 ± 1.05 vs 1.05 ± 1.18 events per patient for DCBs and PTA, respectively) and projected treatment outcomes to 3 years. The second approach was based on the trial-observed access circuit primary patency rates at 12 months (53.8% vs 32.4%) and calculated the cost difference on the basis of previously published Medicare cost for patients who maintained or did not maintain primary patency. Assumptions regarding DCB device prices were tested in sensitivity analyses, and the numbers needed to treat were calculated., Results: Using the absolute number of access circuit reinterventions approach, the DCB strategy resulted in an estimated per-patient savings of $1,632 at 1 year and $4,263 at 3 years before considering the DCB device cost. The access circuit primary patency approach was associated with a per-patient cost savings of $2,152 at 1 year and $3,894 at 2.5 years of follow-up. At the theoretical DCB device reimbursement of $1,800, savings were $1,680 and $2,049 at 2.5 and 3 years, respectively. The one-year NNT of DCB compared to PTA was 2.48., Conclusions: Endovascular therapy for arteriovenous access stenosis with the IN.PACT AV DCB can be expected to be cost-saving if longer follow-up data confirm its clinical effectiveness., (Copyright © 2022 SIR. Published by Elsevier Inc. All rights reserved.)

Objective: The management of popliteal artery aneurysms (PAAs) has undergone significant transition from open surgery to endovascular graft placement with few longitudinal data evaluating outcomes.Methods: The Centers of Medicare&Medicaid Services Inpatient claims (2005-2007) were queried with a diagnosis of lower extremity artery aneurysm in association with elective Current Procedural Terminology codes for open (OPEN group) and endovascular (ENDO group) repair. Results: A total of 2962 patients were identified. Endovascular interventions significantly increased over the time of the study (11.7% vs 23.6%, P < .0001). Overall complication rates for OPEN and ENDO groups did not differ significantly (11.3% vs 9.3%; P¼.017). No differences in the 30- and 90- day mortality rates were found between OPEN versus ENDO groups. The ENDO group had greater 30- and 90-day reinterventions (4.6%vs 2.1%, P¼.001 and 11.8%vs 7.4%, P¼.0007, respectively). Length of stay (4.5 days vs 2.5 days, P < .0001) and charges ($43 180 vs $35 540, P < .0001) were greater for OPEN group. Conclusion: Despite a significant increase in the utilization of endovascular repair of PAAs, endovascular repair was associated with greater reinterventions over time and did not offer a mortality or cost benefit. [ABSTRACT FROM AUTHOR]

Background: Popliteal artery stenting is not routinely performed due to concerns related to the high mobility of the knee joint and the potential for external stent compression, fractures, and occlusion. Open bypass is traditionally considered the gold standard for popliteal artery atherosclerotic lesions. The Supera stent (IDEV Technologies Inc, Webster, Tex) was developed to provide superior radial strength, fracture resistance, and flexibility compared with laser-cut nitinol stents. This study represents the initial United States experience in the management of popliteal artery atherosclerotic disease with the Supera interwoven wire stent. Methods: Patients undergoing stent implantation in the 20-month period after the 2008 Food and Drug Administration clearance were included. Medical records, radiographic imaging, and procedural data were examined. Procedural angiograms were classified according to Trans-Atlantic Inter-Society Consensus criteria. Patency and limb loss rates were calculated using Kaplan-Meier analysis. Results: A total of 39 stents were placed in 34 patients due to isolated popliteal artery occlusive disease. Clinical follow-up was a mean of 12.7 months (range, 0.2-33.7 months), and radiologic follow-up was a mean of 8.4 months (range, 0-26.8 months). Most patients had critical limb ischemia (CLI), with tissue loss (38.2%) or rest pain (35.3%) as the indication for intervention. In 20 patients (58.8%), the most distal end of the stent(s) landed in the below-the-knee popliteal segment, 12 (35.3%) landed in the above-the-knee segment, and two (5.9%) landed precisely at the knee. Other than angioplasty and stenting, 47% of patients did not receive any adjuvant concomitant therapy in the treated leg. Two patients underwent concomitant atherectomy of the popliteal segment. Primary, primary assisted, and secondary patency rates by duplex ultrasound imaging were 79.2%, 88.1% and 93%, respectively, by Kaplan-Meier estimates, with a mean stented length of 12 cm. Six instances of stent occlusion were noted, and six patients were identified with hemodynamically significant in-stent stenosis. Three patients sustained limb loss (8.8%), two related to uncontrolled infections, and one due to perioperative ischemic complications (both with patent stents at the time of limb loss). The overall mortality was 8.8% during the study period. Knee roentgenography was performed in all but one patient, and no stent fractures were identified. Conclusions: Stenting of the popliteal artery using the Supera stent system appears to be safe and effective. The interwoven stent design may better serve areas under extreme mechanical stress. Our results with this highly diseased patient population justify a prospective trial in this subject. [Copyright &y& Elsevier]

Peripheral arterial disease (PAD), a major cause of disability, loss of work, and lifestyle changes in the United States, is defined as obstruction of blood flow into an arterial tree excluding the intracranial or coronary circulations. PAD is mostly silent in its early stages, but when lesion obstruction exceeds 50%, it may cause intermittent claudication with ambulation. Further disease progression typically leads to rest pain or frank tissue loss. However, some patients may remain asymptomatic with severe disease because of extensive collateralization in the lower extremity. Estimates of the prevalence of intermittent claudication vary by population, from 0.6% to nearly 10%; the rate increases dramatically with age. Approximately 20% to 25% of patients will require revascularization, while fewer than 5% will progress to critical limb ischemia. Limb loss, although rare, is associated with severe disability and an overall poor prognosis, with 30% to 40% mortality in the first 24 months after limb loss. As with coronary artery disease, the most common cause of syruptomatic obstruction in the peripheral arterial tree is atherosclerosis, a systemic inflammatory process in which cholesterol-laden plaque builds up in the artery and eventually blocks the lumen. Typical risk factors include age, gender, diabetes, tobacco abuse, hypertension, and hyperlipidemia. [ABSTRACT FROM AUTHOR]

Background: Intravascular ultrasound (IVUS) may be a useful adjunct to lower extremity peripheral vascular interventions (PVI) in certain clinical scenarios. We aimed to identify patient- and physician-level characteristics associated with the use of IVUS during first-time femoropopliteal PVI., Methods: We included all Medicare beneficiaries undergoing elective femoropopliteal PVI for claudication or chronic limb-threatening ischemia between 01/01/2019 and 12/31/2019. We excluded patients with prior open or endovascular femoropopliteal intervention and all physicians performing ≤10 PVI during the study period. We calculated the proportion of patients who had IVUS performed as part of their index PVI for each physician. Hierarchical logistic regression was used to evaluate patient- and physician-level factors associated with use of IVUS., Results: We identified 58,552 patients who underwent index femoropopliteal PVI, of whom 11,394 (19%) received IVUS. A total of 1,628 physicians performed >10 procedures during the study period, with IVUS utilization ranging from 0-100%. After hierarchical regression, claudication (versus chronic limb-threatening ischemia: OR 1.23, 95% CI 1.11-1.36), stenting (versus angioplasty alone: OR 1.57, 1.33-1.86) and atherectomy (versus angioplasty alone: OR 2.09, 1.83-2.39) were associated with higher odds of IVUS utilization. Higher-volume providers (tertile 3 vs. tertile 1: OR 3.78, 2.43-5.90) and those with high rates of service provided in an office-based laboratory (tertile 3 vs. tertile 1: OR 10.72, 6.78-19.93) were more likely to utilize IVUS. Radiologists (OR 11.23, 5.96-21.17) and cardiologists (OR 1.97, 1.32-2.93) used IVUS more frequently than vascular surgeons., Conclusions: Wide variability exists in the use of IVUS for first-time femoropopliteal PVI. The association of IVUS with claudication, atherectomy, and office-based laboratories raises concern about its potential overuse by some physicians., (Copyright © 2021 Elsevier Inc. All rights reserved.)

Peripheral artery disease, along with subsequent critical limb ischemia (CLI), is highly prevalent, increases with age, and carries high morbidity and mortality. Specific devices for treatment of below-the-knee (BTK) lesions are limited. On February 17, 2021, the United States Food and Drug Administration convened a virtual meeting of the Circulatory System Devices Panel of the Medical Devices Advisory Committee to consider a premarket approval application for the Lutonix 014 Drug-Coated Balloon Percutaneous Transluminal Angioplasty Catheter (Becton, Dickinson and Company, Franklin Lakes, New Jersey) for the treatment of obstructive de novo or non-stented restenotic lesions in BTK vessels (popliteal, tibial, and peroneal arteries) in patients with CLI. We summarize the presentations and the panel deliberations, including voting outcome and recommendations for risk versus benefit., Competing Interests: Declaration of competing interest Ron Waksman– Advisory Board: Abbott Vascular, Amgen, Boston Scientific, Cardioset, Cardiovascular Systems Inc., Medtronic, Philips, Pi-Cardia Ltd.; Consultant: Abbott Vascular, Amgen, Biotronik, Boston Scientific, Cardioset, Cardiovascular Systems Inc., Medtronic, Philips, Pi-Cardia Ltd., Transmural Systems; Grant Support: AstraZeneca, Biotronik, Boston Scientific, Chiesi; Speakers Bureau: AstraZeneca, Chiesi; Investor: MedAlliance; Transmural Systems. All other authors – None., (Copyright © 2021. Published by Elsevier Inc.)

Objective: Traumatic popliteal artery injuries are associated with the greatest risk of limb loss of all peripheral vascular injuries, with amputation rates of 10% to 15%. The purpose of the present study was to examine the outcomes of patients who had undergone operative repair for traumatic popliteal arterial injuries and identify the factors independently associated with limb loss., Methods: A multi-institutional retrospective review of all patients with traumatic popliteal artery injuries from 2007 to 2018 was performed. All the patients who had undergone operative repair of popliteal arterial injuries were included in the present analysis. The patients who had required a major lower extremity amputation (transtibial or transfemoral) were compared with those with successful limb salvage at the last follow-up. The significant predictors (P < .05) for amputation on univariate analysis were included in a multivariable analysis., Results: A total of 302 patients from 11 institutions were included in the present analysis. The median age was 32 years (interquartile range, 21-40 years), and 79% were men. The median follow-up was 72 days (interquartile range, 20-366 days). The overall major amputation rate was 13%. Primary repair had been performed in 17% of patients, patch repair in 2%, and interposition or bypass in 81%. One patient had undergone endovascular repair with stenting. The overall 1-year primary patency was 89%. Of the patients who had lost primary patency, 46% ultimately required major amputation. Early loss (within 30 days postoperatively) of primary patency was five times more frequent for the patients who had subsequently required amputation. On multivariate regression, the significant perioperative factors independently associated with major amputation included the initial POPSAVEIT (popliteal scoring assessment for vascular extremity injury in trauma) score, loss of primary patency, absence of detectable immediate postoperative pedal Doppler signals, and lack of postoperative antiplatelet therapy. Concomitant popliteal vein injury, popliteal injury location (P1, P2, P3), injury severity score, and tibial vs popliteal distal bypass target were not independently associated with amputation., Conclusions: Traumatic popliteal artery injuries are associated with a significant rate of major amputation. The preoperative POPSAVEIT score remained independently associated with amputation after including the perioperative factors. The lack of postoperative pedal Doppler signals and loss of primary patency were highly associated with major amputation. The use of postoperative antiplatelet therapy was inversely associated with amputation, perhaps indicating a protective effect., (Copyright © 2021 Society for Vascular Surgery. All rights reserved.)

Objective: Traumatic popliteal vascular injuries are associated with the highest risk of limb loss of all peripheral vascular injuries. A method to evaluate the predictors of amputation is needed because previous scores could not be validated. In the present study, we aimed to provide a simplified scoring system (POPSAVEIT [popliteal scoring assessment for vascular extremity injuries in trauma]) that could be used preoperatively to risk stratify patients with traumatic popliteal vascular injuries for amputation., Methods: A review of patients sustaining traumatic popliteal artery injuries was performed. Patients requiring amputation were compared with those with limb salvage at the last follow-up. Of these patients, 80% were randomly assigned to a training group for score generation and 20% to a testing group for validation. Significant predictors of amputation (P < .1) on univariate analysis were included in a multivariable analysis. Those with P < .05 on multivariable analysis were assigned points according to the relative value of their odds ratios (ORs). Receiver operating characteristic curves were generated to determine low- vs high-risk scores. An area under the curve of >0.65 was considered adequate for validation., Results: A total of 355 patients were included, with an overall amputation rate of 16%. On multivariate regression analysis, the risk factors independently associated with amputation in the final model were as follows: systolic blood pressure <90 mm Hg (OR, 3.2; P = .027; 1 point), associated orthopedic injury (OR, 4.9; P = .014; 2 points), and a lack of preoperative pedal Doppler signals (OR, 5.5; P = .002; 2 points [or 1 point for a lack of palpable pedal pulses if Doppler signal data were unavailable]). A score of ≥3 was found to maximize the sensitivity (85%) and specificity (49%) for a high risk of amputation. The receiver operating characteristic curve for the validation group had an area under the curve of 0.750, meeting the threshold for score validation., Conclusions: The POPSAVEIT score provides a simple and practical method to effectively stratify patients preoperatively into low- and high-risk major amputation categories., (Copyright © 2021 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.)

Objective: Despite the increasing use of endovascular therapy for traumatic arterial injuries, little is known about the outcomes of endovascular repair of superficial femoral artery (SFA) and popliteal artery (PA) injuries. In the present study, we compared the characteristics and outcomes of endovascular vs open repair of traumatic SFA and PA injuries., Methods: We performed a retrospective National Trauma Data Bank analysis of trauma patients with a blunt or penetrating injury of the SFA and/or PA who had undergone endovascular or open repair from 2007 to 2014. Multivariate logistic regression was used to compare the outcomes, with propensity score matching used for sensitivity analysis., Results: The incidence of SFA and PA injuries was 0.2%, with an overall increase in the annual use of endovascular stent repair from 3.2% in 2007 to 7.6% in 2014 (P = .002). A total of 2,873 patients with an isolated SFA and/or PA injury were included in the present study, of whom 163 (5.7%) had undergone endovascular repair. SFA injuries were more frequently treated with endovascular repair (70% vs 27%) and PA injuries were more often associated with open repair (41.1% vs 54.7%). Open repair was more frequently associated with a concomitant femur fracture or knee dislocation (30.7% vs 38.8%; P = .039). Endovascular repair was not associated with worse in-hospital amputation-free survival (AFS) compared with open repair on univariate analysis (91.1% vs 89.7%; P = .573) or multivariate logistic regression (odds ratio [OR], 1.053; 95% confidence interval [CI], 0.551-2.012; P = .876). Propensity score matching revealed that in-hospital mortality was higher (OR, 3.69; 95% CI, 1.37-9.82; P = .01) and fasciotomy was lower (OR, 0.23; 95% CI, 0.14-0.37; P < .001) in the endovascular repair group, with no significant differences in AFS (OR, 0.86; 95% CI, 0.48-1.67; P = .65)., Conclusions: Endovascular repair of SFA and PA injuries has in-hospital AFS comparable to that for open repair, supporting the increasing use of endovascular repair for traumatic SFA and PA injuries in appropriately selected cases. Given the unexpected finding of increased in-hospital mortality after endovascular repair, further studies are necessary to determine the appropriate patient selection and the durability of endovascular repair., (Copyright © 2021 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.)

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.

Objective: Traumatic popliteal artery injury is associated with an increased propensity for limb loss, morbidity, and mortality above an already elevated baseline risk to life and limb. Previous studies of outcomes in this patient group have been limited by selection bias. This study analyzed outcomes after blunt popliteal artery injury using propensity matching to reduce confounding variables associated with multiple mechanisms of traumatic vascular injury and to identify factors associated with amputation., Methods: A retrospective review was conducted of prospectively collected data from the National Trauma Data Bank. Patients were identified using International Classification of Diseases, Ninth Revision codes related to patterns of blunt injury associated with popliteal arterial injury or intervention. Using Trauma Quality Improvement Program variables as a reference, specific characteristics were collected. Variables found significant on univariate analysis were used to generate propensity-matched amputation and nonamputation cohorts. Multivariate logistic regression was used to assess for risk factors associated with amputation and inpatient mortality., Results: In total, 3029 patients with blunt popliteal artery injury were identified; 628 (20.7%) underwent amputation. Patients who underwent amputation presented with more frequent hypotension (systolic blood pressure of 0-99 mm Hg, 22.7% vs 12.8%; P < .001) and tachycardia (heart rate >120 beats/min, 28.5% vs 14.5%; P < .001). Limb loss was also associated with concurrent popliteal vein injury (18.3% vs 8.7%; P < .001) and tibial nerve injury (5.3% vs 1.3%; P < .001) as well as with elevated Injury Severity Score (median, 13 vs 9; P < .001) and lower extremity Abbreviated Injury Scale score (3 vs 2; P < .001). Subsequently, 794 patients were divided into equal number propensity-matched amputation and nonamputation cohorts. Regression analysis revealed that patients with diabetes mellitus (odds ratio [OR], 1.763; P = .049), popliteal vein injury (OR, 1.657; P = .012), or tibial nerve injury (OR, 3.537; P = .007) were more likely to undergo amputation. Further regression analysis with patients matched for Injury Severity Score revealed that age ≥86 years (OR, 38.092; P = .009), patellar fracture (OR, 3.445; P = .036), and elevated Abbreviated Injury Scale score (OR, 1.101; P < .001) were associated with higher risk of inpatient death., Conclusions: Trauma patients who sustain blunt popliteal artery injury are at an increased risk of amputation. Propensity-matched analysis revealed that concurrent popliteal vein and tibial nerve injury but not severity of tissue injury predicted limb loss., (Copyright © 2020 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.)

Purpose: To report outcomes of a multicenter feasibility study using the FLEX Vessel Prep (VP) System, a novel technology that facilitates plaque incision and lumen gain in stenosed or occluded femoropopliteal arteries prior to balloon angioplasty., Materials and Methods: Two hundred fifty-five patients (mean age 71.8±9.1 years) were treated with the FLEX VP System at 38 centers between December 2015 and November 2017. Average lesion length was 133±88 mm. Average baseline stenosis was 92%±11%; 112 (44.3%) of 253 patients presented with a chronic total occlusion. Conventional or drug-coated balloon (DCB) angioplasty was performed in all patients after vessel preparation. Vessel measurements were derived from angiograms acquired at baseline, after FLEX passage, and after subsequent ancillary procedures. Logistic regression analyses were performed to identify baseline or procedure variables that predicted the need for provisional stenting., Results: Average percent reduction in vessel stenosis following treatment with the FLEX VP System was 27%±17%. No flow-limiting dissection, vessel perforation, or embolization was observed; 15 (5.9%) patients had minor (type A or B) dissections. Provisional stenting was performed in 49 (19.2%) patients. Average stenosis following angioplasty ± stenting was 9.1%±7.4%; 9 (3.6%) patients had significant residual stenosis ≥30%. Logistic regression analyses found that patients with dissections, longer lesions, and those receiving conventional balloon dilation alone were most likely to undergo stenting., Conclusion: In a real-world patient population with long, complex femoropopliteal lesions, use of the FLEX VP System as vessel preparation for angioplasty improved acute outcomes compared to historical controls. The rate of provisional stenting was low, and no serious vessel complications were observed.

Purpose: To examine whether laser atherectomy combined with drug-coated balloons (laser + DCB) can improve the outcomes of femoropopliteal (FP) in-stent restenosis (ISR)., Methods: A dual-center retrospective study was conducted of 112 consecutive patients (mean age 70.3±10.6 years; 86 men) with Tosaka class II (n=29; diffuse stenosis) or III (n=83; occlusion) FP-ISR lesions. Sixty-two patients (mean age 68.5±10 years; 51 men) underwent laser + DCB while the other 50 patients (mean age 72.5±10.8 years; 35 men) had laser atherectomy plus balloon angioplasty (laser + BA). Critical limb ischemia was the indication in 33% of the interventions. The average lesion length was 247 mm. A Cox regression hazard model was developed to examine the association between laser + DCB vs laser + BA; the results are presented as the hazard ratio (HR) and 95% confidence interval (CI). One-year target lesion revascularization (TLR) and reocclusion were estimated using the Kaplan-Meier method., Results: Overall procedure success was 98% and was similar between groups. Bailout stenting was less often required in the laser + DCB group (31.7% vs 58%, p=0.006). The combination of laser + DCB was associated with improved 12-month estimates for freedom from TLR (72.5% vs 50.5%, p=0.043) and freedom from reocclusion (86.7% vs 56.9%, p=0.003). Among patients with Tosaka III FP-ISR, combination therapy with laser + DCB was also associated with increased freedom from reocclusion (87.1% vs 57.1%, p=0. 028). On multivariable analysis, treatment with laser + DCB was associated with a significantly reduced risk of reocclusion (HR 0.08, 95% CI 0.17 to 0.38; p=0.002)., Conclusion: When used for treatment of complex FP-ISR lesions, DCB angioplasty combined with laser atherectomy is associated with significantly reduced 1-year TLR and reocclusion rates.

Objectives: To study the economic impact on payers and providers of the four main endovascular strategies for the treatment of infrainguinal peripheral artery disease., Background: Bare metal stents (BMS), drug-eluting stents (DES), and drug-coated balloons (DCB) are associated with lower target lesion revascularization (TLR) probabilities than percutaneous transluminal angioplasty (PTA), but the economic impact is unknown., Methods: In December 2012, PubMed and Embase were systematically searched for studies with TLR as an endpoint. The 24-month probability of TLR for each treatment was weighted by sample size. A decision-analytic Markov model was used to assess the budget impact from payers' and facility-providers' perspectives of the four index procedure strategies (BMS, DES, DCB, and PTA). Base cases were developed for U.S. Medicare and the German statutory sickness fund perspectives using current 2013 reimbursement rates., Results: Thirteen studies with 2,406 subjects were included. The reported probability of TLR in the identified studies varied widely, particularly following treatment with PTA or BMS. The pooled 24-month probabilities were 14.3%, 19.3%, 28.1%, and 40.3% for DCB, DES, BMS, and PTA, respectively. The drug-eluting strategies had a lower projected budget impact over 24 months compared to BMS and PTA in both the U.S. Medicare (DCB: $10,214; DES: $12,904; uncoated balloons $13,114; BMS $13,802) and German public health care systems (DCB €3,619; DES €3,632; BMS €4,026; PTA €4,290)., Conclusions: DCB and DES, compared to BMS and PTA, are associated with lower probabilities of target lesion revascularization and cost savings for U.S. and German payers., (© 2014 Wiley Periodicals, Inc.)

Purpose: To report a subgroup analysis comparing safety and effectiveness outcomes in Japanese and non-Japanese patients as part of a prospective, multinational, randomized controlled trial (ClinicalTrials.gov identifier NCT00120406) evaluating a paclitaxel-coated drug-eluting stent (DES) compared to percutaneous transluminal angioplasty (PTA) for treating peripheral artery disease., Methods: Patients were randomly assigned to primary DES or PTA. In the Japanese cohort, 27 patients (21 men; mean age 71.2±9.6 years) were randomized to PTA and 25 patients (19 men; mean age 69.8±10.2 years) to primary DES. In the non-Japanese cohort, 211 patients (131 men; mean age 67.3±10.6 years) were randomized to PTA and 211 patients (136 men; mean age 67.6±9.5 years) to primary DES. Outcome measures included event-free survival (EFS), freedom from target lesion revascularization (TLR), patency, stent fracture, and sustained clinical benefit through 2 years., Results: Safety and effectiveness outcomes were similar in the Japanese and non-Japanese cohorts, although the outcomes in the Japanese cohort treated with primary DES were numerically better. In the DES group, the 2-year EFS was 92.0% vs. 85.0% (p=0.61), freedom from TLR was 96.0% vs. 85.5% (p=0.55), primary patency was 80.0% vs. 74.3% (p=0.61), and clinical benefit was sustained in 88.5% vs. 80.5% of patients (p=0.31) in the Japanese and non-Japanese cohorts, respectively. Stent fractures were seen in 4 of 457 stents at 12 months: 3 in the Japanese cohort and 1 in the non-Japanese cohort., Conclusion: The subgroup analysis comparing Japanese and non-Japanese patients supports the safety and effectiveness of the paclitaxel-coated DES in Japanese patients with stenotic lesions in the femoropopliteal arteries. The lack of major differences associated with ethnicity in these 2-year outcomes supports the validity and value of multinational clinical trials.

Purpose: To evaluate the role of orbital atherectomy in calcified infrapopliteal arteries in patients with critical limb ischemia compared to balloon angioplasty (BA) alone., Methods: A randomized multicenter study was undertaken to evaluate short and 1-year outcomes in 50 patients (32 men; mean age 71 years, range 40-90) with confirmed calcified lesions using 1∶1 randomization to the Diamondback 360° Orbital Atherectomy System followed by BA vs. BA alone. All patients had severe (≥50% stenosis) peripheral artery disease (Rutherford classification 4-6) in the popliteal, tibial, and/or peroneal arteries. The primary endpoint was defined as restoration of a normal lumen (residual stenosis ≤30%) with no bailout stenting or dissection types C through F. Scheduled follow-up visits were conducted according to a common protocol at 1, 6, and 12 months., Results: Procedural success was 93.1% (27/29 lesions) for atherectomy + BA patients and 82.4% (28/34 lesions) for BA alone (p = 0.27). Bailout stenting was needed in 2 (6.9%) of the 29 atherectomy + BA lesions and in 5 (14.3%) of the 35 BA-treated lesions (p = 0.44). At 1 year, there were no amputations in either group related to the index procedure. Estimates for freedom from target vessel revascularization and all-cause mortality were 93.3% and 100% in the atherectomy + BA group vs. 80.0% (p = 0.14) and 68.4% (p = 0.01) in the BA group, respectively. Proportional hazard models evaluating survival time vs. status of residual stenosis determined a hazard ratio for major adverse events of 5.6 for patients with an acute post-procedure residual stenosis >30% (p = 0.01)., Conclusion: Debulking with orbital atherectomy appeared to increase the chance of reaching a desirable angioplasty result, with less acute need for bailout stenting and a higher procedure success. A negative association between procedure success and risk of serious adverse outcomes should encourage larger confirmatory studies.

Background: Injury of a popliteal fossa artery during orthopaedic knee surgery is very rare but has serious consequences. The risk of vascular trauma during orthopaedic procedures may be increased when there is abnormal branching of the popliteal artery with an aberrant anterior tibial artery originating above the popliteus muscle and coursing between the posterior tibial cortex and ventral margin of the popliteus muscle. Preoperative identification of this anatomical variant may help avoid these injuries., Hypothesis: The aberrant anterior tibial artery is present in a substantial portion of the population and can be visualized by magnetic resonance imaging., Study Design: Cross-sectional study; Level of evidence, 3., Methods: Retrospective review of 1116 consecutive knee magnetic resonance imaging studies was performed to evaluate the prevalence of an aberrant anterior tibial artery. Images were reviewed by 3 musculoskeletal radiologists., Results: The aberrant anterior tibial artery was present in 23 of 1116 extremities for a prevalence of 2.1%. The aberrant artery was most easily identified on axial and sagittal magnetic resonance imaging scans., Conclusion: The aberrant anterior tibial artery is a relatively common normal variant, and magnetic resonance is an excellent modality for detection of the artery close to the posterior joint capsule and tibial cortex., Clinical Relevance: The anatomy suggests the aberrant anterior tibial artery may be at greater risk of injury in orthopaedic procedures such as high tibial osteotomy, revision total knee arthroplasty, lateral meniscal repair, posterior cruciate ligament reconstruction, and screw fixation for tibial tubercle osteotomy. Careful inspection of preoperative magnetic resonance imaging studies may alert the surgeon to the presence of this anatomical variant.

Purpose: Previous studies have attempted to determine the incidence and mortality rate of abdominal aortic aneurysms in a variety of populations; however, the incidence of iliac, femoral, and popliteal artery aneurysms have not been established. The objective of this study was to determine the incidence of lower extremity aneurysms in hospitalized patients in the state of Utah, which has a population at low risk for cardiovascular disease, atherosclerosis, and smoking, and to compare the results with the incidence in the United States., Methods: Incidences of iliac, femoral, and popliteal artery aneurysm in Utah were determined over a 6-year period, with data obtained via diagnostic codes from the Utah Hospital Association. The incidence of iliac, femoral, and popliteal artery aneurysms in the United States hospital population was calculated by use of National Hospital Discharge Summary 1990 data, a complex sample of nonfederal short-stay hospitals in the United States, which provides the most comprehensive database of health statistics in the United States., Results: The incidence of iliac femoral/popliteal artery aneurysms in hospitalized Utah men is 3.76 and 4.85 per 100,000 population, respectively. In American men, iliac and femoral/popliteal artery aneurysm incidences are 6.58 and 7.39 per 100,000 population, respectively. Incidences among hospitalized women in Utah are 0.24 and 1.07 per 100,000; incidences in women in the United States are 0.26 and 1.00 per 100,000, respectively. The incidence of nonaortic peripheral aneurysms among hospitalized patients in Utah is lower than in the United States. The rate ratios (Utah/United States) for incidences of iliac, femoral, and popliteal artery aneurysms in men are 0.57 and 0.66, respectively (p < 0.05). No statistical difference is seen between incidences in women in Utah and the United States (p > 0.05)-ratios of 0.93 and 1.06, respectively., Conclusion: This study validates the traditional belief that iliac, femoral, and popliteal artery aneurysms are much less frequent, at least in hospitalized patients, than previously published incidences of abdominal aortic aneurysms.