Hybrid superficial venous arterialization and endovascular deep venous arterialization.

We report on two venous arterialization (VA) techniques for treatment of CLTI in patients traditionally considered as having no treatment options for standard arterial endovascular or surgical bypass procedures. Screening and the preprocedural workup findings are outlined as deciding factors in determining a patient's fitness for the two techniques, with a focus on careful preprocedure arterial duplex ultrasound and assessment for vein suitability. Cardiac and infection screening are also factors in determining patient suitability for VA. In addition, radiographic assessment for the presence of medial artery calcification, which is used as a marker of technical difficulty and is a predictor of poor outcomes, is required. Ultimately, anatomic factors are used to determine the decision between hybrid superficial VA and or endovascular deep VA. Those with an occluded anterior tibial artery and suitable great saphenous vein are prioritized to hybrid superficial VA, and those with an occluded posterior tibial artery to endovascular deep VA. Both procedures are described in detail in this report of vascular and surgical techniques.

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.

Very Late Aortic Endograft Infection With Listeria monocytogenes in an Elderly Man.

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.

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.

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.

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.

GLASS (Global Limb Anatomic Staging System): a critical appraisal.

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.

Association Between Wearable Device-Based Measures of Physical Frailty and Major Adverse Events Following 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 <0.20), prefrail (FI ≥0.20 to <0.35), or frail (FI ≥0.35), respectively. Within 30 days after surgery, 24 (15.7%) developed MAEs, either major adverse cardiovascular events (MACE; 8 [5.2%]) or major adverse limb events (MALE; 16 [10.5%]). Baseline demographic characteristics were not significantly different between frailty groups. In contrast, the FI was approximately 30% higher in the group that developed MAEs (mean [SD] score, 0.36 [0.14]) than those who were MAE free (mean [SD] score, 0.26 [0.13]; P = .001), with observed MAE rates of 4 patients (7.5%), 7 patients (12.1%), and 13 patients (31.7%) in the robust, prefrail and frail groups, respectively (P = .004). The FI distinguished individuals who developed MACE and MALE from those who were MAE free (MACE: mean [SD] FI score, 0.38 [0.16]; P = .03; MALE: mean [SD] FI score, 0.35 [0.13]; P = .004) after adjusting by body mass index. Conclusions and Relevance: In this cohort study, measuring physical frailty using a wrist-worn sensor during a short upper extremity test was a practical method for stratifying the risk of MAEs following revascularization for CLTI when the administration of gait-based tests is often challenging.

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.

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.

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.

Percutaneous suction thrombectomy of large tumor thrombus causing massive pulmonary embolism.

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.

Pilot study evaluating the efficacy of exergaming for the prevention of deep venous thrombosis.

OBJECTIVE: 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. METHODS: 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. RESULTS: 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). CONCLUSIONS: 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.

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.

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.

Preliminary results of the initial United States experience with the Supera woven nitinol stent in the popliteal artery.

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.

Resultados del tratamiento endovascular de la patología carotídea en el Hospital San Juan de Dios de enero 2007 a febrero 2010 / Results of endovascular management of carotid disease at San Juan de Dios Hospital from January 2007 to February 2010

Justificación y objetivo: Determinar la morbi-mortalidad de los pacientes con enfermedad carotídea tratados por medio de stent en el Hospital San Juan de Dios, Costa Rica; de Enero 2007 a Febrero 2010. Métodos: Se realizó un registro retrospectivo observacional de los pacientes con Enfermedad Carotídea durante 13 meses en nuestro instituto. Basado en la información obtenida de los expedientes clínicos, dos subgrupos fueron identificados: pacientes sintomáticos y asintomáticos. Los factores de riesgo, escala ABCD2, territorio cerebral afectado, medidas de severidad de lesión no-invasiva e invasivas, tamaño de stents y finalmente complicaciones peri-operatorias, fueron investigadas y evaluadas. Resultados: 76 pacientes fueron identificados en nuestra serie, 87 por ciento,( n= 66/76), sintomáticos y 13 por ciento, (n = 10/76), asintomáticos. La hipertensión arterial fue el factor de riesgo más frecuente, seguido por el tabaquismo. Se evidenció una sub-estimación de la severidad de la lesión en los ultrasonidos diagnósticos en 24 por ciento, (n= 18/76), de los pacientes. Durante el procedimiento, se documentó predilatación de la lesión en 55 por ciento,( n= 42/76), de los pacientes y los stents más frecuentemente utilizados fueron de 7x30mm y 8x30mm representando un 47 por ciento, (n= 36/76), de los casos. La morbilidad neurológica de los pacientes asintomáticos fue del 0 por ciento y en el subgrupo de pacientes sintomáticos fue del 3 por ciento, 2/66. Conclusión: La terapia endovascular demostró ser una técnica segura y efectiva para la revascularización carotídea. Series más numerosas de pacientes deberían ser investigadas para adquirir mayor significancia estadística.

Retrograde approach for complex popliteal and tibioperoneal occlusions.

PURPOSE: To describe the technical aspects of the retrograde approach for endovascular treatment of complex popliteal and/or tibioperoneal occlusions and determine its efficacy in minimizing failure rates. METHODS: An observational registry of retrograde revascularizations was maintained at our institution over 14 months (September 2006 to December 2007). During this time frame, antegrade revascularization failed in 62 (17.8%) of 343 limbs with complex total occlusions of the popliteal and/or infrapopliteal vascular territory. Of these antegrade failures, 51 (82.2%) limbs in 51 patients (32 men; mean age 72+/-8 years) were suitable for a retrograde attempt. From this subgroup, 45 (88.2%) were treated via a percutaneous transpedal access site and 6 (11.8%) via a transcollateral intra-arterial technique. RESULTS: The overall success rate was 86.3% (44/51); adjunctive stenting was needed in 21 (41.1%) to optimize results. Only 1 (1.9%) major complication (a pedal access site occlusion) and 4 (7.8%) minor sequelae (arterial perforation in 3 and a pedal hematoma without consequence) were documented. CONCLUSION: In complex popliteal to infrapopliteal occlusions, an antegrade recanalization attempt can fail in up to 20% of the cases. The additional use of a retrograde approach seems feasible and safe and can favorably modify this failure rate. This technique could be valuable for patients with critical limb ischemia due to popliteal and infrapopliteal occlusions once larger studies with follow-up confirm safety, efficacy, and clinical benefit.