Transcatheter Arterialization of Deep Veins in Chronic Limb-Threatening Ischemia.

BACKGROUND: Approximately 20% of patients with chronic limb-threatening ischemia have no revascularization options, leading to above-ankle amputation. Transcatheter arterialization of the deep veins is a percutaneous approach that creates an artery-to-vein connection for delivery of oxygenated blood by means of the venous system to the ischemic foot to prevent amputation. METHODS: We conducted a prospective, single-group, multicenter study to evaluate the effect of transcatheter arterialization of the deep veins in patients with nonhealing ulcers and no surgical or endovascular revascularization treatment options. The composite primary end point was amputation-free survival (defined as freedom from above-ankle amputation or death from any cause) at 6 months, as compared with a performance goal of 54%. Secondary end points included limb salvage, wound healing, and technical success of the procedure. RESULTS: We enrolled 105 patients who had chronic limb-threatening ischemia and were of a median age of 70 years (interquartile range, 38 to 89). Of the patients enrolled, 33 (31.4%) were women and 45 (42.8%) were Black, Hispanic, or Latino. Transcatheter arterialization of the deep veins was performed successfully in 104 patients (99.0%). At 6 months, 66.1% of the patients had amputation-free survival. According to Bayesian analysis, the posterior probability that amputation-free survival at 6 months exceeded a performance goal of 54% was 0.993, which exceeded the prespecified threshold of 0.977. Limb salvage (avoidance of above-ankle amputation) was attained in 67 patients (76.0% by Kaplan-Meier analysis). Wounds were completely healed in 16 of 63 patients (25%) and were in the process of healing in 32 of 63 patients (51%). No unanticipated device-related adverse events were reported. CONCLUSIONS: We found that transcatheter arterialization of the deep veins was safe and could be performed successfully in patients with chronic limb-threatening ischemia and no conventional surgical or endovascular revascularization treatment options. (Funded by LimFlow; PROMISE II study ClinicalTrials.gov number, NCT03970538.).

Early experience with venous arterialization for limb salvage in no-option patients with chronic limb-threatening ischemia.

OBJECTIVE: 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. METHODS: 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. RESULTS: 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%. CONCLUSIONS: 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.

Persistent under-representation of female patients in United States trials of common vascular diseases from 2008 to 2020.

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 < 0.04; P > .45). The PPR did not vary significantly over time for any of the funding sources (for each, r2 < 0.85, P > .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.

Guillotine Transmetatarsal Amputations With Staged Closure Promote Early Ambulation and Limb Salvage in Patients With Advanced Chronic Limb-Threatening Ischemia.

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.

Gender, Racial and Ethnic Disparities in Iatrogenic Vascular Injuries among the Ten Most Frequent Surgical Procedures in the United States.

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 to 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 ≤ 0.01). Among the ten index procedures, Non-Hispanic (NH) Whites underwent the highest proportion of procedures (14.1 procedures/100 hospitalizations; P < 0.01) and cholecystectomy was associated with the highest rate of IaVI's (19.4 per 1000 hospitalizations, P ≤ 0.01). Overall, patients from the lowest income quartile were least likely to suffer IaVI's (0.83 95% CI 0.79-0.88, P < 0.01) compared to the highest income quartile. All form of healthcare coverage increased the odds of IaVI's: Medicaid (1.07 95% CI 1.07-1.13, P < 0.01); Private insurance (1.35 95% CI 1.3-1.39, P < 0.01); Self-pay or no charge (1.45 95% CI 1.38-1.52, P < 0.01). IaVI's increased the odds of in-hospital mortality in all groups (1.25 95% CI 1.14-1.35, P < 0.01) and more pronounced in NH-Blacks (1.51 95% CI 1.15-1.99, P < 0.01). In the overall cohort, urban teaching hospitals observed the highest odds of in-hospital mortality (1.11 95% CI 1.07-1.15, P < 0.01). CONCLUSION: Between 2008 to 2015, IaVI's rates for the top ten most frequently performed inpatient procedures increased by 33.6% (4.2% annually; P < 0.01). The elderly, females, and Hispanics more frequently had hospitalizations complicated by IaVI's. Overall, IaVI's independently increased the adjusted odds of mortality by 25%. IaVI's were most fatal among Blacks, about 50% elevated risk of death compared to NH-Whites. These benchmarks will be critical to future efforts to reduce IaVI, and associated healthcare disparities.

Safety and efficacy of an endovascular-first approach to acute limb ischemia.

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.

A Novel Scoring System for Small Artery Disease and Medial Arterial Calcification Is Strongly Associated With Major Adverse Limb Events in Patients With Chronic Limb-Threatening Ischemia.

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.

Assessment of foot perfusion: Overview of modalities, review of evidence, and identification of evidence gaps.

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.

Endovascular Therapy in an "All-Comers" Risk Group for Chronic Limb-Threatening Ischemia Demonstrates Safety and Efficacy When Compared with the Established Performance Criteria Proposed by the Society for Vascular Surgery.

BACKGROUND: 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). METHODS: 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. RESULTS: 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 OPG<3%), MALE was 4.1% (OPGR = 7.1%, nOPGR = 0%, P = 0.135, vs. SVS OPG<8%), and MACE was 6.9% (OPGR = 2.3%, nOPGR = 13.3%, P = 0.071, vs. SVS OPG<8%). The limb salvage was 90.3% (OPGR = 88%, nOPGR = 93.3%, P = 0.46, vs. SVS OPG>84%), MALE + POD was 76.4% (OPGR = 78.6%, nOPGR = 73.4%, P = 0.606, vs. SVS OPG>71%), and survival was 77.7% (OPGR = 83.3%, nOPGR = 70%, P = 0.18, vs. SVS OPG>80%). CONCLUSIONS: 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.

Using the Society for Vascular Surgery Wound, Ischemia, and foot Infection classification to identify patients most likely to benefit from revascularization.

BACKGROUND: The Society of Vascular Surgery Wound Ischemia foot Infection (WIfI) classification system for chronic limb-threatening ischemia was intended to predict 1-year major lower extremity amputation (LEA) risk and to identify which patients benefit most from revascularization. We aimed to identify which WIfI presentations benefited most from revascularization to explore whether a cluster analysis could identify a more data-driven WIfI score, and to quantify which component of the WIfI score was most strongly associated with 1-year LEA after revascularization. METHODS: Composite multi-institutional nested cohort data from centers who previously validated WIfI were reviewed retrospectively. We collected each patient's WIfI component grades and whether LEA was performed. To examine the benefit of revascularization, the predicted LEA rates were subtracted from observed LEA rates. We used k-means cluster analysis to model predicted vs observed LEA rates after revascularization. Multivariable linear regression analysis was performed to quantify which WIfI score component(s) best predicted LEA. RESULTS: Data from 10 centers, accumulated between 2005 and 2015 were collated (2878 limbs at risk; 314 LEAs performed). The subset of patients who underwent revascularization comprised the study base (1654 limbs; 169 LEAs). Of 64 potential WIfI grade combinations, 15 were never reported and were excluded from the analysis. By original WIfI stages, the observed LEA rate after revascularization was: stage 1, 10.8% (14/130); stage 2, 4.9% (5/103); stage 3, 5.1% (25/487); and stage 4, 13.4% (125/934). Based on the difference between predicted and observed LEA risk for those who underwent revascularization, the WIfI scores were placed into quartiles from greatest to no benefit of revascularization. Cluster analysis identified four clusters with the following 1-year LEA rates: cluster 1, 4.4% (46/1038); cluster 2, 14.8% (66/447); cluster 3, 28.1% (36/128); and cluster 4, 51.2% (21/41). The between sum of squares/total sum of squares was 93.9%. Multiple linear regression revealed the wound grade most strongly predicted LEA (F-value, 17.25; P < .001). Ischemia (F-value, 6.51; P = .001) and infection (F-value, 5.7; P = .003) were similarly associated with LEA risk. Interaction terms between each component of the WIfI score were not statistically significant. CONCLUSIONS: WIfI can identify which patients with chronic limb-threatening ischemia are most likely to benefit from revascularization and may provide improved prognostication, risk stratification, and equitable outcome assessments. After revascularization, wound severity is most strongly associated with LEA risk. Ischemic and infectious grades confer additive, but not synergistic, risk. Future cluster analyses comparing specific WIfI presentations treated with and without revascularization will be required to further refine WIfI.

Multidisciplinary Care for Critical Limb Ischemia: Current Gaps and Opportunities for Improvement.

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.

Outcome Comparison between Open and Endovascular Management of TASC II D Aortoiliac Occlusive Disease.

BACKGROUND: 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. METHODS: 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. 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). CONCLUSIONS: 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.

Endovascular management of inferior vena cava filter thrombotic occlusion.

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.

Increasing use of endovascular therapy in pediatric arterial trauma.

BACKGROUND: 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. METHODS: 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. RESULTS: 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. CONCLUSIONS: 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.

Key Concepts in Critical Limb Ischemia: Selected Proceedings from the 2015 Vascular Interventional Advances Meeting.

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.

Analysis of endovascular therapy for femoropopliteal disease with the Supera stent.

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.

Tibiopedal Access for Crossing of Infrainguinal Artery Occlusions: A Prospective Multicenter Observational Study.

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.

Systematic Review of Guidelines for the Management of Asymptomatic and Symptomatic Carotid Stenosis.

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.

The First-in-Man "Si Se Puede" Study for the use of micro-oxygen sensors (MOXYs) to determine dynamic relative oxygen indices in the feet of patients with limb-threatening ischemia during endovascular therapy.

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.

Pharmacomechanical thrombolysis in the management of acute inferior vena cava filter occlusion using the Trellis-8 device.

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.