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Purpose:To evaluate the roles of small artery disease (SAD) and medial arterial calcification (MAC) in patients with chronic limb-threatening ischemia (CLTI) and to identify any correlation between these factors and peripheral artery disease (PAD) or outcomes after treatment.Materials and Methods:A retrospective review was conducted of 259 limbs with tissue loss among 223 CLTI patients (mean age 72.2±11.4 years; 194 men) having an angiographic foot vessel study, foot radiography, and at least 6 months of follow-up after intervention. SAD and MAC were quantified using a 3-level score (0=absent, 1=moderate, 2=severe) based on angiography for SAD and foot radiographs for MAC. The MAC score was validated and compared with the SAD score, evaluating their associations with PAD distribution and clinical outcomes.Results:Based on the MAC score, the 259 limbs were classified as 55 group 0 (21.2%), 89 group 1 (34.4%), and 115 group 2 (44.4%). The SAD score stratified the 259 limbs as 67 group 0 (25.9%), 76 group 1 (29.3%), and 116 group 2 (44.8%). Interobserver reproducibility of the MAC score was high (correlation coefficient 0.96). Sensitivity and specificity of the MAC score in detecting SAD was 100% and 98.1%, respectively, in SAD groups 0 and 2 vs 99.1% and 92.7%, respectively, for SAD group 1. PAD was more proximal in MAC and SAD groups 0 and more distal in groups 1 and 2. Both MAC and SAD scores were able to predict clinical endpoints. Multivariable analysis demonstrated that the MAC score represents an independent risk factor for adverse limb events.Conclusion:SAD and MAC must be considered expressions of the same obstructing disease, able to adversely impact the fate of CLTI patients. SAD and MAC scores are powerful prognostic indicators of major adverse limb events in CLTI patients.

The aim of this study was to describe the applicability of the Society for Vascular Surgery (SVS) objective performance goals (OPGs) as a tool to evaluate results in the context of endovascular management of noncomplex and complex patients (i.e., end stage renal disease/history of prosthetic conduit) with chronic limb-threatening ischemia (CLTI).Patients diagnosed with CLTI undergoing endovascular procedures from March 2016 to April 2017 were included, and medical records were examined. Patients were categorized as OPG risk (OPGR) and non-OPG risk (nOPGR) groups in accordance with the SVS performance criteria. We compared clinical events between the two groups and then further to the SVS OPGs. Thirty-day outcomes (safety) were major amputation (AMP), major adverse limb events (MALEs), and major adverse cardiovascular events (MACEs), and 1-year outcomes (efficacy) were limb salvage, MALE + 30-day perioperative death (MALE + POD), and survival. Mortality was demonstrated using Kaplan-Meier analysis.A total of 72 patients were included (OPGR = 58.3% vs. nOPGR = 41.7%). Mean follow-up was 20 months (range, 1-40 months). Retrograde pedal access was used in 65.2% of patients. The overall AMP rate was 2.7% (OPGR = 4.7%, nOPGR = 0%, P = 0.225, vs. SVS OPG3%), MALE was 4.1% (OPGR = 7.1%, nOPGR = 0%, P = 0.135, vs. SVS OPG8%), and MACE was 6.9% (OPGR = 2.3%, nOPGR = 13.3%, P = 0.071, vs. SVS OPG8%). The limb salvage was 90.3% (OPGR = 88%, nOPGR = 93.3%, P = 0.46, vs. SVS OPG84%), MALE + POD was 76.4% (OPGR = 78.6%, nOPGR = 73.4%, P = 0.606, vs. SVS OPG71%), and survival was 77.7% (OPGR = 83.3%, nOPGR = 70%, P = 0.18, vs. SVS OPG80%).The SVS OPGs set appropriate safety and efficacy standards as a bar for new technologies. In this series, endovascular therapy in all-comers exceeded the safety and efficacy endpoints proposed by the limited risk OPG panel.

Patients with critical limb ischemia have nonhealing wounds and/or ischemic rest pain and are at high risk for amputation and mortality. Accurate evaluation of foot perfusion should help avoid unnecessary amputation, guide revascularization strategies, and offer efficient surveillance for patency. Our aim is to review current modalities of assessing foot perfusion in the context of the practical clinical management of patients with critical limb ischemia.

Endograft infection with Listeria monocytogenes is a rare, potentially devastating complication of endovascular aortic aneurysm repair. To our knowledge, only 8 cases have been reported. We describe the case of a 72-year-old man who presented with L. monocytogenes endograft infection and a 19-cm degenerative aneurysm 9 years after having undergone endovascular repair of an abdominal aortic aneurysm. The infection was successfully treated with open surgical excision of the infected aortoiliac endograft and its replacement with a rifampin-soaked, bifurcated Dacron graft.

An evaluation of the 30-day safety and performance outcomes of the Phoenix atherectomy system (Philips Volcano Corporation) was performed in real-world patients with peripheral artery disease (PAD).The Phoenix Post-Approval Registry is an all-comer study that enrolled patients with infrainguinal PAD. Patients treated with the Phoenix atherectomy system were followed for 30 days to observe device-related complications. Outcomes evaluated include procedural (final target lesion(s) residual stenosis of ≤30% after treatment with Phoenix and any other adjunctive therapy) and technical success (defined as achieving a post-Phoenix [prior to any adjunctive therapy] residual diameter stenosis of ≤50%), target-vessel revascularization (TVR), target-lesion revascularization (TLR), target-limb amputation, ankle brachial index, Rutherford clinical category, and wound, ischemia, foot infection (WIfI) classification.Of the 500 patients enrolled, 259 had CLI, including 26.3% with Rutherford class 6. Procedural success rates were 97.3% for non-CLI patients and 98.2% for CLI patients. Technical success rates were 71.5% for non-CLI patients and 77.9% for CLI patients. Complication rates post Phoenix atherectomy were1%. Through the 30-day follow-up, there were 6 patients (1.3%; 2 claudicants, 4 CLIs) who underwent TLR and 8 patients who underwent TVR. There were no major amputations in the non-CLI and CLI cohorts. In the CLI cohort, 16/235 (6.8%) underwent minor amputations. Higher stages of Rutherford class and WIfI classification were associated with amputations at 30 days.The Phoenix atherectomy system is a safe and effective treatment option in the acute setting for patients with PAD, including those with advanced Rutherford class. Randomized controlled trials are needed to confirm these results.

Purpose: Transmetatarsal amputation (TMA) with primary closure has long been an option for limb salvage in patients with advanced chronic limb-threatening ischemia (CLTI) with extensive tissue loss of the forefoot. However, TMA healing and closure techniques are challenging, specifically in high-risk patients. Guillotine transmetatarsal amputations (gTMA) with staged closure may provide an alternative treatment in this population. We report long-term outcomes of such technique. Materials and Methods: A single-center retrospective cohort study of CLTI patients undergoing gTMA between 2017 and 2020 was performed. Limb salvage, wound healing, and survival rates were quantified using Kaplan-Meier (KM) analysis. Multivariate regression was used to identify the effect of patient characteristics on the outcomes. Results: Forty-four gTMA procedures were reviewed. Median follow-up was 381 (interquartile range [IQR], 212–539.75) days. After gTMA, 87.8% (n=36) of the patients were able to ambulate after a median interval of 2 (IQR, 1–3) days. Eventual coverage was achieved in a personalized and staged approach by using a combination of skin substitutes (88.6%, n=39) ± split thickness skin grafts (STSG, 61.4%, n=27). KM estimates for limb salvage, wound healing, and survival were 84.1%, 54.5%, and 88.6% at 1 year and 81.8%, 63.8%, and 84.1% at 2 years. Wound healing was significantly associated with STSG application (p=0.002, OR=16.5, 95% CI 2.87–94.81). Conclusion: gTMA resulted in high limb salvage rates during long-term follow-up in CLTI patients. Adjunctive STSG placement may enhance wound healing at the gTMA site, thus leading to expedited wound closure. Surgeons may consider gTMA as an alternative to reduce limb loss in CLTI patients at high risk of major amputation. Clinical Impact Currently, the clinical presentation of CLTI is becoming more complex to deal with due to the increasing comorbidities as the society becomes older. The data shown in this article means for clinicians that when facing diffused forefoot gangrene and extensive tissue loss, limb preservation could still be considered instead of major amputation. Guillotine transmetatarsal amputations in the setting of an aggressive multidisciplinary group, can be healed by the responsibly utilization of dermal substitutes and skin grafts leading to the preservation of the extremity, allowing mobility, avoiding of sarcopenia, and decreasing frailty. This will equate to maintenance of independent living and preservation of lifespan.

Chronic limb-threatening ischemia (CLTI) is associated with adverse limb outcomes and increased mortality. However, a small subset of the CLTI population will have no feasible conventional methods of revascularization. In such cases, venous arterialization (VA) could provide an alternative for limb salvage. The objective of the present study was to review the outcomes of VA at our institution.We performed a single-institution review of 41 patients who had been followed up prospectively and had undergone either superficial or deep VA. The data collected included patient demographics, comorbidities, VA technique (endovascular vs hybrid), and WIfI (wound, ischemia, and foot infection) limb staging. Data were collected at 1-month, 6-month, and 1-year intervals and included the following outcomes: patency, wound healing, major adverse limb events, major amputation, and death. Descriptive statistics were used for analysis.The study group included 41 patients who had undergone successful open hybrid superficial or deep endovascular VA; 21 (51.2%) had undergone a purely endovascular procedure and 20 (48.8%), hybrid VA. The WIfI clinical stage was as follows: stage 4, 33 (80.5%); stage 3, 6 (14.6%); and stage 2, 1 (2.4%). Of the 41 patients, 24 (58.5%) had completed follow-up at 6 months and 16 (39%) at 1 year. At 1 year, the VA primary patency was 28.6% (95% confidence interval [CI], 0.15%-0.43%), primary assisted patency was 44.3% (95% CI, 0.27%-0.60%), and secondary patency was 67% (95% CI, 0.49%-0.80%). The complete wound healing rate was 2.7% (n = 1) at 1 month, 62.5% (n = 15) at 6 months, and 18.8% (n = 3) at 1 year. Overall wound healing at 1 year was 46.3% (n = 19). The number of major adverse limb events at 1 year was 15 (36.5%) and included 8 reinterventions (19.5%) and 7 major amputations (17%). The number of deaths was zero (0%) at 1 month and four (19%) at 6 months. Two deaths (9.5%) were attributed to COVID-19 (coronavirus disease 2019). No further deaths had occurred within 1 year. The limb salvage survival probability at 1 year was 81%.These findings suggest that for a select subset of CLTI patients presenting with a high WIfI clinical limb stage and no viable options for conventional open or endovascular arterial revascularization, superficial and deep VA are feasible options to achieve limb salvage.

OBJECTIVE Iatrogenic vascular injuries (IaVI's) appear to be increasing, with disparate prevalence across gender, race and ethnicity. We aim to assess the risk of IaVI's across these characteristics. METHODS Using the Nationwide Inpatient Sample for the years 2008-2015, we identified rates of IaVI's among the top ten most frequently performed inpatient procedures in the United States. Joint point regression was employed to examine the trends in the rates of IaVI's. We also calculated the adjusted odds ratios for IaVI's using survey logistic regression. RESULTS During the eight-year study period, a total of 29,877,180 procedures were performed (33.6% hip replacement, 14% knee arthroplasty, 11.2% cholecystectomy, 10.3% spinal fusion, 8.9% lysis of adhesions, 8% colorectal resection, 7.9% partial bone excision, 5% appendectomy, 0.6% percutaneous coronary angioplasty, 0.6% laminectomy). A total of 194,031 (0.65%) IaVI's were associated with these procedures. The incidence of IaVI's increased over time with an average annual percentage change (AAPC) of 4.2% (95% CI: 3.1, 5.4; P < 0.01). More females (105,747; 54.5%) than males (88,284; 45.5%) suffered IaVI's during their hospital admission (p < 0.01). Patients 70 years of age and older had the highest incidence of IaVI's (12,244,082; 34.3%; p =

Background Women have been historically under-represented in vascular surgery and cardiovascular medicine trials. The rate and change in representation of women in trials of common vascular diseases over the last decade is not understood completely. Methods We used publicly available data from ClinicalTrials.gov to evaluate trials pertaining to carotid artery stenosis (CAS), peripheral arterial disease (PAD), thoracic and abdominal aortic aneurysms (TAA and AAA), and type B aortic dissections (TBAD) from 2008 to the present. We evaluated representation of women in these trials based on the participation-to-prevalence ratios (PPR), which are calculated by dividing the percentage of women among trial participants by the percentage of women in the disease population. Values of 0.8 to 1.2 reflect similar representation. Results The sex distribution was reported in all 97 trials, including 11 CAS trials, 68 PAD trials, 16 TAA/AAA trials, and 2 TBAD trials. The total number of participants in these trials was 41,622 and the median number of participants per trial was 150.5 (interquartile range [IQR], 50-252). The percentage of women in the disease population was 51.9% for CAS, 53.1% for PAD, 34.1% for TAA/AAA, and 30.9% for TBAD. Industry sources funded 76 of the trials (77.6%), and the Veterans Affairs Administration (n = 4 [4.1%]), unspecified university (n = 7 [7.1%]), and extramural sources (n = 11 [11.2%]) funded the remainder of the trials. The overall median PPR for all four diseases was 0.65 (IQR, 0.51-0.80). Women were under-represented for all four conditions studied (CAS, 0.73 [IQR, 0.62-0.96]; PAD, 0.65 [IQR, 0.53-0.77]; TAA/AAA, 0.59 [IQR, 0.38-1.20]; and TBAD, 0.74 [IQR, 0.65-0.84]). There was no significant difference in PPR among the diseases (P = .88). From 2008 to the present, there was no significant change in PPR values over time overall (r2 = 0.002; P = .70). When examined individually, PPR did not change significantly over time for any of the diseases studied (for each, r2 .45). The PPR did not vary significantly over time for any of the funding sources (for each, r2 .08). There was appropriate representation (PPR of 0.8-1.2) in a minority of trials for each disease except TBAD (CAS, 27.3%; PAD, 15.9%; TAA/AAA, 18.8%; and TBAD, 50%). Trials that were primarily funded from university sources had the highest median PPR (1.04; IQR, 0.21-1.27), followed by industry-funded (0.67; IQR, 0.54-0.81), and extramurally funded (0.60; IQR, 0.34-0.73). Studies funded by Veterans Affairs had the lowest PPR (0.02; IQR, 0.00-0.11; P = .004). Conclusions Participation of women in US trials of common vascular diseases remains low and has not improved since 2008. Therefore, the generalizability of recent trial results to women with these vascular diseases remains unknown. An improved understanding of the underlying root causes for poor female trial participation, advocacy, and education are required to improve the generalizability of trial results for female vascular patients.

Background THE Global Vascular Guidelines (GVGs) propose a new Global Anatomic Staging System (GLASS) resulting in three stages of complexity for intervention. The aim of this study was to retrospectively classify a large cohort of CLTI patients according to the GLASS, evaluating its distribution in a real-world setting. Methods Retrospective, single center, observational study enrolling all consecutive CLTI patients submitted to infra-inguinal endovascular revascularization in our institution, between June 2014 and September 2019. Patients were categorized according to the GLASS for femoro-popliteal (FP), infra-popliteal (IP) and infra-malleolar grading. FP and IP grades were merged to get the final GLASS stage for each limb. Results The study included 1995 CLTI patients who underwent 2850 endovascular procedures in which 6009 arterial lesions were successfully treated. The FP segment was classified as: 1292 (45.3%) grade 0, 475 (16.6%) grade 1, 159 (5.6%) grade 2, 209 (7.4%) grade 3, and 715 (25.1%) grade 4. The IP segment was classified as: 1529 (53.6%) grade 0, 183 (6.4%) grade 1, 80 (2.8%) grade 2, 207 (7.3%) grade 3, and 851 (29.9%) grade 4. The combination of FP and IP grading led to GLASS stages: 922 (32.3%) stage 1, 375 (13.2%) stage 2, 1472 (51.6%) stage 3. Conclusions The distribution of the FP, IP and final GLASS grading was mainly grouped at the two extremes, letting the intermediate grades rather scarce. The majority of patients present with an absent or severely diseased pedal arch, stressing the need to incorporate infra-malleolar disease into the GLASS.

Background The optimal techniques to manage acute limb ischemia (ALI) remain unclear. Previous reports have suggested that the decreased morbidity and mortality of endovascular approaches are mitigated by the limited technical success rates relative to open or hybrid approaches for ALI. However, these data failed to include newer technologies that might improve the technical success rates. We, therefore, sought to describe the current outcomes for an endovascular-first approach to ALI. Methods We performed a single-center, single-arm, retrospective cohort study of consecutive patients with ALI from 2015 to 2018. Technical success, limb salvage, survival, patency, and length of stay were quantified using Kaplan-Meier (KM) analysis. Cox regression analysis was used to identify the predictors of amputation-free survival. Results During the 3 years, 60 consecutive patients (39 men [65%]; median age, 65 years) presented with ALI. The Rutherford class was I in 15 patients (25%), IIa in 23 (38%), IIb in 13 (22%), and III in 9 patients (15%). Of the 60 patients, 34 had a history of previous failed ipsilateral revascularization (56%), including open bypass for 8 (13%), endovascular for 8 (13%), and both open and endovascular intervention for 18 (30%). The endovascular-first approach procedures included catheter-directed thrombolysis only (n = 19; 3%), catheter-directed thrombolysis plus aspiration and/or rheolytic thrombectomy (n = 19; 32%), and aspiration and/or rheolytic thrombectomy (n = 16; 26%). Six patients (10%) underwent covered stent placement only. The underlying occlusive process was most often thrombosis of a previous bypass graft or stent in 32 patients (53%), followed by native vessel thrombosis in 15 (25%). ALI had resulted from embolism in 13 patients (21.7%), including 2 (3%) with embolization to occlude a previous bypass graft or stent. Technical success was achieved in 58 patients (97%), with open conversion required in two patients (3%). At 30 days postoperatively, 52 patients (87%) survived, and 53 (88%) had successful limb salvage. Five patients (8%) had required four-compartment fasciotomy. No major hemorrhagic complications developed. The median length of stay overall and in the intensive care unit was 9 days (interquartile range, 4-14 days) and 2 days (interquartile range, 1-5 days), respectively. At 1 year, the KM estimates were as follows: amputation-free survival, 58% ± 0.08%; limb salvage, 74.3% ± 0.07%; and survival, 73.3% ± 0.07%. The 1-year KM estimates for primary and secondary patency were 39.4% ± 0.08% and 78.2% ± 0.07%, respectively. On multivariable Cox regression analysis, only age independently predicted for death and/or amputation at the last follow-up (hazard ratio, 1.06; 95% confidence interval, 1.01-1.10; P = .01). Conclusions The current endovascular approaches to ALI have high technical success rates. Survival, limb salvage, perioperative complications, and length of stay were similar to those from previous reports of historical open cohorts. Further prospective, appropriately powered, multicenter cohort studies are warranted to evaluate the efficacy of endovascular vs open approaches to ALI.

Critical limb ischemia (CLI), defined as ischemic rest pain or nonhealing ulceration due to arterial insufficiency, represents the most severe and limb-threatening manifestation of peripheral artery disease. A major challenge in the optimal treatment of CLI is that multiple specialties participate in the care of this complex patient population. As a result, the care of patients with CLI is often fragmented, and multidisciplinary societal guidelines have not focused specifically on the care of patients with CLI. Furthermore, multidisciplinary care has the potential to improve patient outcomes, as no single medical specialty addresses all the facets of care necessary to reduce cardiovascular and limb-related morbidity in this complex patient population. This review identifies current gaps in the multidisciplinary care of patients with CLI, with a goal toward increasing disease recognition and timely referral, defining important components of CLI treatment teams, establishing options for revascularization strategies, and identifying best practices for wound care post-revascularization.

We describe a patient who underwent a renal cell carcinoma resection with inferior vena cava thrombectomy complicated by tumor embolization. This resulted in massive pulmonary embolism requiring venous-arterial extracorporeal membrane oxygenation. The patient was ineligible for systemic or catheter-directed thrombolysis because of the recent surgical resection and postoperative hemorrhage. Hence, the patient underwent percutaneous suction thrombectomy with successful removal of the tumor thrombus and significant clinical improvement. This report represents a unique case of suction thrombectomy for the removal of tumor embolus from the pulmonary circulation and highlights the ability of suction thrombectomy in the management of massive pulmonary embolism. Keywords: Pulmonary embolism, Continuous aspiration embolectomy, Renal cell carcinoma

Current prophylactic protocols fail to prevent deep venous thrombosis (DVT) in a significant minority of patients, and it remains one of the leading causes of preventable death. We therefore quantified the efficacy of novel game-based exercises (exergaming) to augment femoral venous parameters relative to ankle movement and muscle flexion.Healthy volunteers were recruited to perform a series of ankle and foot exercises using a wireless foot sensor (LEGSys; BioSensics LLC, Watertown, Mass) to navigate a computer cursor sequentially on a screen to the center of 200 circular targets. A single ultrasound technician (W.A.M.) measured each patient's mean flow volume, peak flow velocity, mean flow velocity, and cross-sectional area of the right femoral vein at baseline and obtained immediate postexercise (PEX), 5-minute PEX, and 15-minute PEX measurements. Electromyography (EMG) was performed at baseline and during the exercise. Baseline demographics and medical and surgical comorbidities were also recorded. The primary end point was the difference between baseline and immediate PEX mean flow volume estimates. We secondarily explored the association of baseline characteristics and EMG measurements with femoral vein parameters.Fifteen healthy subjects (53% male; 28.1 ± 4.6 years) completed the exergaming task within a mean of 4 minutes, 2 ± 21 seconds. Immediately after exercise, the femoral vein mean flow volume, mean velocity, and peak systolic velocity increased by 49%, 53%, and 48%, respectively (P .02 for each). Mean flow volume and velocity remained significantly elevated 5 minutes after exercise (P .04 for each). Plantar flexion and dorsiflexion velocities and EMG frequency and intensity were not significantly correlated with PEX mean flow volume estimates (P.05). Subgroup analysis revealed that women (P .01) and Hispanics (P .01) exhibited significantly slower PEX responses. Subjects with the largest improvements in mean flow volume had lower peak plantar flexion velocities (P .01).Exergaming increases mean flow volume, mean flow velocity, and peak systolic velocity within the femoral vein by approximately 50% above baseline. Exergaming represents a novel and potentially attractive method of DVT prevention by augmenting femoral vein mean volume flow and capitalizing on biofeedback. Less forceful but more uniform contractions were found to be most effective at augmenting venous blood flow. Exergaming will require further validation in larger study bases, among patients at higher risk of DVT.

Background The structural limitations of currently available laser-cut nitinol stents in the highly diseased arterial system of the lower extremity are well described. These devices are frequently used in long-segment occlusions, at the adductor hiatus, and across the knee into the popliteal artery and tibial-peroneal trunk despite concerns related to the high mobility of the knee joint and the potential for external stent compression, fractures, and occlusion. The Supera stent (Abbott Vascular, Santa Clara, Calif) was developed to provide superior radial strength, fracture resistance, and flexibility compared with laser-cut nitinol stents. This study represents the initial U.S. experience in the management of lower extremity 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 TransAtlantic Inter-Society Consensus criteria. Patency and limb loss rates were calculated using Kaplan-Meier analysis. Results There were 305 stents implanted in 147 patients. 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, 0.2-26.8 months). Most patients had critical limb ischemia, with tissue loss (38.1%) or rest pain (28.6%) as the indication for intervention. Of the 147 patients, 75 (51.02%) underwent a concomitant adjunctive procedure in the treated extremity. Primary, assisted primary, and secondary patency rates at 12 months by duplex ultrasound imaging were 89.8%, 91.2%, and 93.2%, respectively, by Kaplan-Meier estimates, with a mean lesion length of 184.5 ± 131.80 mm and mean stented length of 197.5 ± 113.65 mm. Seventeen patients experienced an event requiring successful reintervention in the stented segment (13 for type I or II restenosis; four for type III). There were eight major amputations, with five of those eight having a patent stent at the time of limb sacrifice. The overall mortality was 11.6% during the study period. Knee radiography was performed in 47 patients with devices extending into the popliteal and tibial-peroneal segment, and no stent fractures were identified. Conclusions Stenting of the superficial femoral and popliteal arteries 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 population of highly diseased patients including very long lesion lengths are consistent with outcomes of other publications reporting the use of this device.

Purpose: To report a prospective, multicenter, observational study ( ClinicalTrials.gov identifier NCT01609621) of the safety and effectiveness of tibiopedal access and retrograde crossing in the treatment of infrainguinal chronic total occlusions (CTOs). Methods: Twelve sites around the world prospectively enrolled 197 patients (mean age 71±11 years, range 41-93; 129 men) from May 2012 to July 2013 who met the inclusion criterion of at least one CTO for which a retrograde crossing procedure was planned or became necessary. The population consisted of 64 (32.5%) claudicants (Rutherford categories 2/3) and 133 (67.5%) patients with critical limb ischemia (Rutherford category ≥4). A primary antegrade attempt to cross had been made prior to the tibiopedal attempt in 132 (67.0%) cases. Techniques used for access, retrograde lesion crossing, and treatment were at the operator’s discretion. Follow-up data were obtained 30 days after the procedure. Results: Technical tibiopedal access success was achieved in 184 (93.4%) of 197 patients and technical occlusion crossing success in 157 (85.3%) of the 184 successful tibial accesses. Failed access attempts were more common in women (9 of 13 failures). The rate of successful crossing was roughly equivalent between sexes [84.7% (50/59) women compared to 85.6% (107/125) men]. Technical success did not differ significantly based on a prior failed antegrade attempt: the access success rate was 92.4% (122/132) after a failed antegrade access vs 95.4% (62/65) in those with a primary tibiopedal attempt (p=0.55). Similarly, crossing success was achieved in 82.8% (101/122) after a failed antegrade access vs 90.3% (56/62) for patients with no prior antegrade attempt (p=0.19). Minor complications related to the access site occurred in 11 (5.6%) cases; no patient had access vessel thrombosis, compartment syndrome, or surgical revascularization. Conclusion: Tibiopedal access appears to be safe and can be used effectively for the crossing of infrainguinal lesions in patients with severe lower limb ischemia.

Key Points Question Is a wrist-worn frailty meter (FM) that quantifies physical frailty using a 20-second repetitive elbow flexion-extension test a feasible tool for evaluating the risk of 30-day major adverse events (MAEs) after lower-limb revascularization? Findings In this 2-center cohort-study of 152 patients, all participants were able to perform the FM test within 1 week before revascularization, whereas most were unable to perform a gait test because of the presence of foot ulcers. The FM distinguished between those with and without 30-day MAEs. Meaning The results of this study suggest that the FM is feasible and may support surgeons in evaluating the risks and benefits of revascularization in older adults., This cohort study tests a frailty meter that does not rely on gait to determine the risk of 30-day major adverse events among patients with chronic limb-threatening ischemia who have undergone lower extremity revascularization., Importance Physical frailty is a key risk factor associated with higher rates of major adverse events (MAEs) after surgery. Assessing physical frailty is often challenging among patients with chronic limb-threatening ischemia (CLTI) who are often unable to perform gait-based assessments because of the presence of plantar wounds. Objective To test a frailty meter (FM) that does not rely on gait to determine the risk of occurrence of MAEs after revascularization for patients with CLTI. Design, Setting, and Participants This cohort study included 184 consecutively recruited patients with CLTI at 2 tertiary care centers. After 32 individuals were excluded, 152 participants were included in the study. Data collection was conducted between May 2018 and June 2019. Exposures Physical frailty measurement within 1 week before limb revascularization and incidence of MAEs for as long as 1 month after surgery. Main Outcomes and Measures The FM works by quantifying weakness, slowness, rigidity, and exhaustion during a 20-second repetitive elbow flexion-extension exercise using a wrist-worn sensor. The FM generates a frailty index (FI) ranging from 0 to 1; higher values indicate progressively greater severity of physical frailty. Results Of 152 eligible participants (mean [SD] age, 67.0 [11.8] years; 59 [38.8%] women), 119 (78.2%) were unable to perform the gait test, while all could perform the FM test. Overall, 53 (34.9%), 58 (38.1%), and 41 (27.0%) were classified as robust (FI

Endovascular management of complex aortoiliac occlusive disease (AIOD) has been described as a viable alternative to open surgical reconstruction. To date, few studies have directly compared the 2 techniques. We therefore, evaluated short and mid- term outcomes of open and endovascular therapy in TASC II D AIOD patients.TASC II D patients undergoing treatment between January 2009 and December 2016 were retrospectively reviewed. Patient demographics, clinical data, and outcomes (complications [technical and systemic] and graft patency) were collected. The primary outcome of this study was primary graft patency. Patients were compared according to treatment group (open versus endovascular). Kaplan-Meier curves were used to analyze follow up results.A total of 75 consecutive patients (open: 30; endovascular: 45) were included in this analysis. In the endovascular group, 25 (55.6%) patients were managed using a hybrid approach with 100% technical success. Critical limb ischemia was the indication for intervention in 16.0% of this cohort (open, 13.3% vs. endovascular, 17.8%, P = 0.397). Overall, there were no significant differences in gender (male: open, 50.0% vs. endovascular, 55.6%, P = 0.637) or age (54.5 ± 5.9 years vs. 57.0 ± 8.7 years, P = 0.171). No in hospital deaths occurred in this cohort. The overall complication rate was significantly higher in the open group (43.3% vs. 17.8%, OR 3.5, 95% CI [1.2-10.1], P = 0.016) with peri-operative systemic complications being more likely in the open cohort (40.0% vs. 6.7%, OR 9.3, 95% CI [2.3-37.3], P 0.001) while technical complications did not differ between the 2 groups (6.7% vs. 11.1%, OR 0.6, 95% CI [0.1-3.1], P = 0.517). Follow up data was available for 68 patients (90.7%), for a mean of 21.3 ± 17.1 months (range: 1-72 months). Re-intervention rates were significantly higher in the endovascular group (3.3% vs. 20.0%, OR 7.2, 95% CI [1.1-14.3], P = 0.038). The overall primary patency at 2 years was significantly higher in the open group (96.7% vs. 80.0%, OR 7.2, 95% CI [1.2-60.5], P = 0.038). Cox regression analysis revealed separation of the primary outcome for open therapy relative to endovascular repair (log rank, P = 0.320).In this comparison of open and endovascular therapy for complex AIOD, endovascular therapy was associated with high initial technical success and fewer in-hospital systemic complications but also high re-intervention rates when compared to open repair. Further prospective studies aimed at reduction of complications, optimization of patency, and patient selection for such procedures is warranted.

Background and Purpose— We systematically compared and appraised contemporary guidelines on management of asymptomatic and symptomatic carotid artery stenosis. Methods— We systematically searched for guideline recommendations on carotid endarterectomy (CEA) or carotid angioplasty/stenting (CAS) published in any language between January 1, 2008, and January 28, 2015. Only the latest guideline per writing group was selected. Each guideline was analyzed independently by 2 to 6 authors to determine clinical scenarios covered, recommendations given, and scientific evidence used. Results— Thirty-four eligible guidelines were identified from 23 different regions/countries in 6 languages. Of 28 guidelines with asymptomatic carotid artery stenosis procedural recommendations, 24 (86%) endorsed CEA (recommended it should or may be provided) for ≈50% to 99% average-surgical-risk asymptomatic carotid artery stenosis, 17 (61%) endorsed CAS, 8 (29%) opposed CAS, and 1 (4%) endorsed medical treatment alone. For asymptomatic carotid artery stenosis patients considered high-CEA-risk because of comorbidities, vascular anatomy, or undefined reasons, CAS was endorsed in 13 guidelines (46%). Thirty-one of 33 guidelines (94%) with symptomatic carotid artery stenosis procedural recommendations endorsed CEA for patients with ≈50% to 99% average-CEA-risk symptomatic carotid artery stenosis, 19 (58%) endorsed CAS and 9 (27%) opposed CAS. For high-CEA-risk symptomatic carotid artery stenosis because of comorbidities, vascular anatomy, or undefined reasons, CAS was endorsed in 27 guidelines (82%). Guideline procedural recommendations were based only on results of trials in which patients were randomized 12 to 34 years ago, rarely reflected medical treatment improvements and often understated potential CAS hazards. Qualifying terminology summarizing recommendations or evidence lacked standardization, impeding guideline interpretation, and comparison. Conclusions— This systematic review has identified many opportunities to modernize and otherwise improve carotid stenosis management guidelines.

Acute mesenteric ischemia (AMI) continues to carry high morbidity and mortality. Endovascular strategies have been increasingly used in the management of AMI. The purpose of this study was to evaluate the impact of endovascular therapy on outcomes of patients with AMI. The National Surgical Quality Improvement Program database was queried to identify all patients requiring emergency surgical intervention for AMI. Demographics, clinical data, interventions, and outcomes were extracted. Patients were compared according to treatment (endovascular versus hybrid versus open revascularization). Over the six-year study period, a total of 439 patients were found to have AMI [27 (6.2%) endovascular, 23 (5.2%) hybrid, and 389 (88.6%) open revascularization]. A total of 16 (59.3%) patients in the endovascular group avoided laparotomy. There was a trend toward lower transfusion requirements (intraoperative transfusion: 3.7% for endovascular vs 17.4% for hybrid vs 19.3% for open, adjusted. P = 0.127) and complications in particular pneumonia (22.2% vs 39.1% vs 27.8%, respectively, Adj. P = 0.392) and sepsis (25.9% vs 21.7% vs 35.5%, adjusted P = 0.260). Endovascular therapy was associated with a 2.5-fold decrease in the risk of death [odds ratio, 95% confidence interval: 0.4 (0.2, 0.9), adjusted P = 0.018]. In this analysis of morbidity and mortality, endovascular therapy was associated with decreased need for laparotomy and a trend toward lower transfusion requirements and complications, in particular pneumonia and sepsis. Endovascular first therapy was associated with a 2.5-fold decrease in the risk of death. Further prospective evaluation of these results is warranted.

Objective Inferior vena cava occlusion is a potentially life-threatening complication related to caval filters. We present our experience with filter-induced inferior vena cava occlusion in order to assess the feasibility, safety, and effectiveness of endovascular management. Methods A retrospective review of all patients undergoing inferior vena cava filter placement over a 60-month study period was performed. From this cohort, a total of 10 cases of inferior vena cava occlusion after filter placement were identified. Demographics, clinical data, procedures, and outcomes were extracted. Patients were followed to the last clinic visit or until they died. Results One-hundred eighty filters were placed by our group practice during the study period. Of those, a total of 10 patients were identified. Overall, there were 7 males; the mean age was 57.1 years (25–78 years). The median time between inferior vena cava filter placement and filter occlusion was 105 days (range 5–4745 days). All patients were clinically symptomatic at the time of their presentation. Nine out of 10 patients were successfully managed endovascularly. Trellis™-8 thrombectomy was the most common endovascular strategy performed ( n = 9). Four patients had balloon angioplasty, two of those with stent placement for chronically occluded inferior vena cava/iliac veins. No thromboembolic complications developed during a median follow-up period of 233 days (range 4–1083 days). Conclusions Endovascular management of inferior vena cava occlusion is feasible, safe, and effective in decreasing thrombus burden in the presence of an inferior vena cava filter. Further studies evaluating long-term inferior vena cava patency and optimal surveillance regimen after endovascular management of filter-related inferior vena cava occlusion are warranted.

To evaluate the safety and efficacy of transpedal access for the management of complex peripheral artery disease (PAD).Critical limb ischemia is associated with high risk of limb loss, as well as cardiovascular and all-cause mortality. Transpedal access is a novel, increasingly utilized technique for the management of complex PAD.We performed a literature search using PubMed from January 2003 to December 2016. Published studies on transpedal access were studied. We evaluated patient sample demographics, procedure indications, access and target vessel, procedural characteristics, outcomes, and complications.Ten studies and 881 patients were included in our study. The indication for transpedal access was critical limb ischemia in 68.4% and severe claudication in 29.5%. A chronic total occlusion was present in 93.7% (average occlusion length, 206 mm). Access was achieved by ultrasound in 57.1% and by fluoroscopy in 35.7%. The anterior tibial or dorsalis pedis were accessed in 54.7% and the posterior tibial in 28.0%. The angiographic procedural success rate was 92.6%. The most commonly reported complication was dissection (7.49%), followed by perforation (1.36%) and embolization (1.25%).Based on the results of this systematic review, transpedal access appears to be a safe and effective technique for complex PAD.

We compared the rates of stroke, death, and/or MI between men and women, stratified by symptomatic status and procedure type (carotid endarterectomy [CEA] or carotid artery stent [CAS]).Using the Nationwide Inpatient Sample, crude and propensity-matched rates of the composite end point of stroke/death/MI were estimated. Multivariable logistic regression was used to calculate the odds of stroke/death/MI associated with sex.Between 2005 and 2015, there were 1,242,688 carotid interventions performed (1,083,912 CEA; 158,776 CAS; 515,789 [41.5%] were female patients). Symptomatic admissions comprised 11.3% of the cohort. In-hospital stroke/death/MI rates were more prevalent in men compared with women (4.2% vs 3.9%; p0.01). Subgroup analysis revealed symptomatic women vs men had higher rates of stroke after CEA (7.7% vs 6.2%; p0.01) and CAS (9.9% vs 7.6%; p0.01). Asymptomatic women experienced the same rates of stroke after either CEA (0.3% vs 0.3%; p = 0.051) or CAS (0.4% vs 0.5%; p = 0.09). Propensity-matched logistic regression revealed that symptomatic males vs females had lower odds of stroke after CEA (odds ratio [OR] 0.81; 95% CI 0.72 to 0.91) and CAS (OR 0.72; 95% CI 0.57 to 0.90). Asymptomatic men and women had similar odds of stroke after both CEA (OR 0.95; 95% CI 0.79 to 1.14) and CAS (OR 0.70; 95% CI 0.43 to 1.13).This is the largest cohort study to date that demonstrates asymptomatic women undergoing CEA or CAS do not have a higher risk of perioperative stroke, death, or MI. Symptomatic men experience lower rates of stroke after CEA or CAS.

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.

Endovascular therapy has been increasingly used for critically injured adults. However, little is known about the epidemiology and outcomes of endovascularly managed arterial injuries in children. We therefore aimed to evaluate recent trends in the endovascular management of pediatric arterial injuries and its association with early survival.An 8-year analysis of the National Trauma Databank (2007-2014) was performed to extract all pediatric trauma patients (aged ≤16 years) with arterial injuries. Demographics, clinical data, interventions (endovascular vs open), and outcomes (in-hospital mortality and length of stay) were extracted. Patients undergoing endovascular or open procedures were compared for differences in clinical characteristics using bivariate analysis. Multivariable logistic regression analysis quantified the association between endovascular therapy and survival in the context of other variables predictive of survival on univariate analysis, with α ≤ .05.There were 35,771 pediatric patients available for analysis. Overall, there was a significant increase in the use of endovascular procedures (from 7.8% in 2007 to 12.9% in 2014; P .001), particularly among blunt trauma patients (5.8% in 2007 to 15.7% in 2014; P .001). Conversely, a significant decrease was noted for open procedures (P .001). There was a stepwise increase in the proportion of patients managed endovascularly as the Injury Severity Score (ISS) increased (highest in the ISS spectrum of 31-50). Angioembolization of internal iliac injury and thoracic aortic endograft placement were the two most common endovascular procedures (n = 88 [33.4%] and n = 60 [22.9%], respectively). There were 331 decedents (9.1% vascular injured children), 242 (73.1%) of whom were dead on arrival. After controlling for differences in demographics and clinical data, when outcomes were compared between patients who underwent endovascular and open procedures, there were no significant differences regarding in-hospital mortality (3.0% vs 3.6%; odds ratio, 0.7; 95% confidence interval, 0.1-6.1; P = .778). A logistic regression model identified Glasgow Coma Scale score ≤8, ISS ≥16, positive result of ethanol or drug screen, and systolic blood pressure 90 mm Hg on admission as independent risk factors for death.The use of endovascular therapy in pediatric vascular arterial trauma has significantly increased, especially among severely injured blunt trauma patients. Despite this successful integration into care, there was no in-hospital survival advantage conferred by endovascular therapy compared with traditional open therapy. Approximately 10% of children with arterial injuries died during initial trauma assessment before therapy could be offered. Glasgow Coma Scale score ≤8, ISS ≥16, positive result of ethanol or drug screen, and systolic blood pressure 90 mm Hg on admission were identified as independent risk factors for death. As children are a population of vulnerable patients, long-term, multicenter studies are required to determine the most appropriate use of and indications for endovascular therapy in pediatric arterial trauma.

Over 500,000 patients each year are diagnosed with critical limb ischemia (CLI), the most severe form of peripheral artery disease. CLI portends a grim prognosis; half the patients die from a cardiovascular cause within 5 years, a rate that is 5 times higher than a matched population without CLI. In 2014, the Centers for Medicare and Medicaid Services paid approximately $3.6 billion for claims submitted by hospitals for inpatient and outpatient care delivered to patients with CLI. Although significant advances in diagnosis, treatment, and follow-up of patients with CLI have been made, many challenges remain. In this article, we summarize selected presentations from the 2015 Vascular Interventional Advances Conference related to the modern demographics, diagnosis, and management of patients with CLI.

Background The increase in life expectancy results in a higher number of patients with an advanced age over 80 years requiring abdominal aortic aneurysm therapy. The aim of this study was to review the outcome of octogenarians undergoing endovascular treatment for abdominal aortic aneurysms. Patients and methods Between June 2004 and March 2008 25 patients (24 males, one female), with a mean age of 83 +/- 2.6 years (range: 80-91 years) underwent elective endovascular treatment for abdominal aortic aneurysms. The average preoperative aneurysm diameter was 57 +/- 9.8 mm (range: 40-80 mm). All procedures were carried out in the angiography suite under general anesthesia. Results Endovascular abdominal aortic aneurysm repair was technically successful in all patients. There was one perioperative death due to an aneurysm-related complication. The perioperative (30 days) mortality rate was 4 %. Intensive care unit admission was required in five patients. The in-hospital morbidity rate was 20 %. Mean follow-up time was 18.7 +/- 14 months (range: 2 to 47 months). Two patients died from unrelated causes. There were no device- or aneurysm-related deaths. A patient with a type I A endoleak underwent correction by additional stent-graft placement four weeks after initial placement. Conclusion Endovascular abdominal aortic aneurysm repair in octogenarians is a valuable alternative to open aortic repair and can be performed safely and successfully. We strongly recommend the endovascular treatment for patients over 80 years of age with an appropriate size of aortic aneurysm.

Purpose: To evaluate the performance and safety of the Trellis-8 system, a pharmacomechanical thrombolysis infusion catheter, and adjunctive therapies in the treatment of symptomatic inferior vena cava (IVC) filter–related acute thrombotic occlusion. Methods: Eight consecutive patients (6 men; mean age 57.4 years, range 34–78 years) with acute thrombotic occlusion of the IVC in the presence of an IVC filter underwent percutaneous venous thrombectomy using the Trellis-8 thrombectomy system and adjunctive techniques between January 2009 and November 2013. Demographics, clinical data, procedures, and outcomes were retrospectively reviewed. All patients had clinical signs of lower extremity venous hypertension on presentation. The median time between IVC filter placement and occlusion was 25 months. Patients were followed for the development of thromboembolic complications to the last clinic visit or until they died. Results: The procedure was technically successful in 6 patients, whereas it could not be performed in 2 due to failure to cross the occlusion. The median follow-up period was 7.8 months, at which time all patients undergoing successful Trellis-8 thrombectomy had relief of symptoms without thromboembolic or bleeding complications. Conclusion: In this limited performance and safety evaluation, the Trellis-8 thrombectomy system combined with adjunctive therapies, such as mechanical thrombectomy and balloon angioplasty, was effective in 75% of patients with IVC filter–related acute caval occlusion.

The twentieth century witnessed a tremendous explosion in the application of minimally invasive, catheter-based interventions in virtually all vascular bed territories, surpassing the number of performed open surgical cases by the end of that time period. This fact allowed a greater number of patients to be candidates for potentially life-saving surgical interventions, many of whom could not have tolerated the superior stresses of an open surgical procedure. The development of such technological advances that can provide significant benefits to our patients does require the participation of both industry and physicians; neither group by themselves could achieve these goals in isolation. Such cooperation is a new paradigm, first tested during the development of laparoscopy in the general surgery specialty and clearly expanded in vascular surgery. Whereas no major technological advances have been reported during the beginning of the twenty-first century in open vascular surgery techniques, major improvements in the endovascular arena have been described, from the technological and technical points of view. This chapter is a concise review of the most recent and important techniques and device developments involved in vascular interventions.

Objective Patients with limb-threatening ischemia exhibit uneven patterns of perfusion in the foot, which makes it challenging to determine adequate topographic perfusion by angiography alone. This study assessed the feasibility of reporting dynamic relative oxygen indices and tissue oxygen concentration from multiple locations on the foot during endovascular therapy using a novel micro-oxygen sensor (MOXY; PROFUSA, Inc, South San Francisco, Calif) approach. Methods A prospective, 28-day, single-arm, observational study was performed in 10 patients who underwent endovascular therapy for limb-threatening ischemia. At least 24 hours before therapy, four microsensors were injected in each patient (one in the arm, three in the treated foot). The optical signal from the microsensors corresponded to tissue oxygen concentration. A custom detector on the surface of the skin was used to continuously and noninvasively measure the signals from the microsensors. The ability to locate and read the signal from each injected microsensor was characterized. Oxygen data from the microsensors were collected throughout the revascularization procedure. The timing of therapy deployment was recorded during the procedure to assess its relationship with the microsensor oxygen data. Oxygen data collection and clinical evaluation were performed immediately postoperatively as well as postoperatively on days 7, 14, 21, and 28. Results The study enrolled 10 patients (50% male) with ischemia (30% Rutherford class 4, 70% Rutherford class 5). Patients were a mean age of 70.7 years (range, 46-90 years), and all were Hispanic of varying origin. Microsensors were successfully read 206 of 212 times (97.2%) in all patients during the course of the study. Microsensors were compatible with intraoperative use in the interventional suite and postoperatively in an office setting. In nine of 10 revascularization procedures, at least one of the three MOXYs showed an immediate change in the dynamic relative oxygen index, correlating to deployed therapy. Moreover, there was a statistically significant increase in the concentration of oxygen in the foot in preoperative levels compared with postoperative levels. No adverse events occurred related to the microsensor materials. Conclusions This MOXY approach appears to be safe when implanted in patients with limb-threatening ischemia undergoing endovascular recanalization and is effective in reporting local tissue oxygen concentrations over a course of 28 days. Further testing is needed to determine its potential effect on clinical decision making, both acutely on-table and chronically as a surveillance modality, which ultimately can lead to improved healing and limb salvage.