Multi-Level Thrombotic/Embolic Burden and Its Role in Sex-Related Outcomes in Acute Limb Ischemia (ALI).

INTRODUCTION: The impact of sex upon outcomes in acute limb ischemia (ALI) remains disputed. We aim to quantify the effect of sex upon amputation-free survival (AFS) after a percutaneous-first approach for ALI. METHODS: Two-center retrospective review of ALI managed via a percutaneous-first approach. Demographics, comorbidities, and clinical characteristics were analyzed (Table I). The Kaplan-Meier and Cox regression were used to estimate AFS, limb-salvage and overall survival. RESULTS: Over nine years, 170 patients (87, 51% males; median age 67 IQR 59, 77 years) presented with ALI. Rutherford Classification was I in 56 (33%); IIa in 85 (50%); IIb in 20 (12%) and III in 9 (5%). Thirty-day mortality, major amputation rate and fasciotomy rates were 8% (N=13); 6.5% (N=11), and 4.7% (N=8), respectively. Among revascularized limbs, 92% were patent at 30 days. Length of stay was 7 (IQR 3-11) days. Complications included 13 bleeding episodes (8%), 4 cases of atrial fibrillation (2%), and 3 re-thrombosis/clot extension events (1.7%). No differences were noted in complication rates when stratified by sex. Females were older than males (median age 70 IQR 62, 79 vs 65 IQR 56, 76 years; p=0.02) and more likely to present with atrial fibrillation (20.5% vs 8%, p 0.02); and hyperlipidemia (72% vs 57%, p = 0.04). Females also more frequently presented with multi-level thrombotic/embolic burden compared to males (56% vs 43%; p=0.03), and required both aspiration thrombectomy and thrombolysis (27% versus 14%; p 0.02). Kaplan-Meier estimated median AFS, limb salvage, and overall survival were 425 (IQR 140, 824 days); 314 (IQR 72, 727 days); and 342 (IQR 112, 762 days). When stratified by sex, females had worse survival (median 270 IQR 92, 636 versus 406 IQR 140, 937 days; p=0.005); and limb salvage (median 241 IQR 88, 636 versus 363 IQR 49, 822 days; p=0.04) compared to males. Univariate Cox regression showed female sex (HR = 1.46 95% CI 1.04-2.05; p=0.03); multi-level thrombotic/embolic burden (HR 1.64 95% CI 1.17-2.31; p=0.004) and Rutherford Class (HR 1.37 95% CI 1.08-1.73; p=0.009) predicted major amputation/death. By multivariable Cox regression, multi-level thrombotic/embolic burden (HR 1.54 95% CI 1.09-2.17; p=0.01), Rutherford Class (HR 1.34 95% CI 1.07-1.69; p=0.01), and female Sex (HR = 1.45 95% CI 1.03-2.05; p=0.03) were each independently predictive of major amputation/death. CONCLUSIONS: A percutaneous-first strategy is safe and efficacious in the overall ALI population. Similar to prior works, female versus male ALI patients in our cohort have higher rates of mortality and major amputation. In our multivariable model, multi-level thrombotic/embolic burden was independently associated with a greater than 45% increased hazard of major amputation/ death at last follow up. Further prospective analysis is warranted to elucidate the underlying factors contributing to the higher prevalence of multi-level thrombotic/embolic burden in female ALI patients, and to further define the optimal percutaneous-first approach for ALI in consideration of patient sex and extent of clot burden.

Transplant Renal Vein Thrombosis Rescued in a Pediatric Patient Using Suction Thrombectomy.

Renal vein thrombosis after kidney transplant is a rare but potentially graft-threatening event. As sequelae of this complication can range from brief acute kidney injury to total graft failure, it is necessary to maintain close clinical observation postoperatively. If posttransplant renal vein thrombosis does occur, recanalization may be attempted with mechanical thrombectomy, suction thrombectomy, or explantation and reimplantation of the allograft. This is a novel report of the successful use of suction thrombectomy to treat renal vein thrombosis in a pediatric kidney transplant.

Use of transcarotid artery revascularization for mechanical thrombectomy and treatment of symptomatic high-grade carotid artery stenosis associated with free-floating thrombus: illustrative case.

BACKGROUND: Patients with symptomatic high-grade stenosis of the internal carotid artery (ICA) associated with a free-floating thrombus (FFT) present a significant clinical challenge. In general, for patients with moderate to severe symptomatic ICA stenosis, carotid revascularization is recommended within 2 weeks of symptom onset; however, some physicians suggest that revascularization should be delayed in cases with FFT because some data suggest that early surgery with carotid endarterectomy or carotid stent poses a higher risk for stroke. Likewise, delayed revascularization with anticoagulation may increase risk of recurrent stroke. Few reports on the management of FTT included the use of a transcarotid artery revascularization (TCAR) approach for carotid revascularization with mechanical aspiration thrombectomy. OBSERVATIONS: This report described the use of TCAR for direct mechanical thrombectomy and carotid stent placement for a patient with 80% right ICA stenosis along with a large FFT extending into the bulb and the external carotid artery. LESSONS: The TCAR approach for mechanical thrombectomy and carotid stenting is a safe alternative for early revascularization with low periprocedural stroke risks.

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.

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.

The Global Limb Anatomic Staging System (GLASS) for CLTI: Improving Inter-Observer Agreement.

OBJECTIVE: The 2020 Global Vascular Guidelines aim at improving decision making in Chronic Limb-Threatening Ischemia (CLTI) by providing a framework for evidence-based revascularization. Herein, the Global Limb Anatomic Staging System (GLASS) serves to estimate the chance of success and patency of arterial pathway revascularization based on the extent and distribution of the atherosclerotic lesions. We report the preliminary feasibility results and observer variability of the GLASS. GLASS is a part of the new global guideline and posed as a promising additional tool for EBR strategies to predict the success of lower extremity arterial revascularization. This study reports on the consistency of GLASS scoring to maximize inter-observer agreement and facilitate its application. METHODS: GLASS separately scores the femoropopliteal (FP) and infrapopliteal (IP) segment based on stenosis severity, lesion length and the extent of calcification within the target artery pathway (TAP). In our stepwise approach, we used two angiographic datasets. Each following step was based on the lessons learned from the previous step. The primary outcome was inter-observer agreement measured as Cohen's Kappa, scored by two (step 1 + 2) and four (step 3) blinded and experienced observers, respectively. Steps 1 (n = 139) and 2 (n = 50) were executed within a dataset of a Dutch interventional RCT in CLTI. Step 3 (n = 100) was performed in randomly selected all-comer CLTI patients from two vascular centers in the United States. RESULTS: In step 1, kappa values were 0.346 (FP) and 0.180 (IP). In step 2, applied in the same dataset, the use of other experienced observers and a provided TAP, resulted in similar low kappa values 0.406 (FP) and 0.089 (IP). Subsequently, in step 3, the formation of an altered stepwise approach using component scoring, such as separate scoring of calcification and adding a ruler to the images resulted in kappa values increasing to 0.796 (FP) and 0.730 (IP). CONCLUSION: This retrospective GLASS validation study revealed low inter-observer agreement for unconditioned scoring. A stepwise component scoring provides acceptable agreement and a solid base for further prospective validation studies to investigate how GLASS relates to treatment outcomes.

Femoral Vein Reconstruction for Aortic Infections.

While rare, abdominal aortic infections remain one of the most technically and emotionally challenging cases that a vascular surgeon may face. Secondary infections of either endovascular, or open aortic reconstructions range from 0.2% to 8%. Primary aortic infections are much more rare. Diagnosis can be elusive, depending upon the virulence of the causative microbes, and extent of the infection. Patients are often brittle, with immunocompromise and malnutrition prevalent in this patient population. The gold standard diagnostic test remains a computed tomographic angiogram. The mainstay of management requires vascular control, and wide debridement of all infected materials and revascularization. Multiple methods exist to reconstruct the vascular supply. The neo-aortoiliac system (NAIS) is attractive as it utilizes the patient's own femoral veins to reconstruct the vascular supply after the infection has been extirpated. The procedure is demanding upon the patient and surgeons alike. Also, the rarity of aortic infections limit experiences the literature to centers of excellence. However, the NAIS resists infection well, leaving the patient without any remaining foreign bodies. No further costs for conduit are incurred. Moreover, multiple experiences show excellent durability. While comparative effectiveness literature remains sparse, we believe the NAIS to be the optimal method of revascularization for select patients. In this article, we will review the use of NAIS for primary and secondary aortic infections. In particular, we will emphasize procedural details to help enable the reader to apply this procedure most effectively to their own 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.

Transumbilical repair of umbilical hernia in children: The covert scar approach.

BACKGROUND: Umbilical hernia repairs are one of the most commonly performed operations in children. The traditional repair involves an infraumbilical incision, which produces a visible scar. We report a novel technique of umbilical hernia repair through a transumbilical incision, which eliminates the scar by hiding it within the umbilicus. METHODS: We performed a retrospective chart review of 134 patients who had undergone a transumbilical hernia repair at a single institution between 2008 and 2016. Satisfaction with cosmesis and the presence of complications were assessed through parental interviews during follow up visit or by telephone survey. These data were compared to a large volume retrospective analysis of the standard infraumbilical approach. RESULTS: 121 of the 134 patients were evaluated in the clinic or by telephone interview. The overall complication rate was 7.44%. Parents of 118 patients reported satisfaction with the cosmetic result (97.52%). In comparison to the largest study of pediatric infraumbilical repair, there was an improvement in subjective cosmesis without a significant increase in complications. CONCLUSION: Transumbilical hernia repair is a safe and cosmetically appealing technique for umbilical hernia repair in children. LEVEL OF EVIDENCE: Treatment study, level III.

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.

Pediatric Liver Transplant Center Volume and the Likelihood of Transplantation.

BACKGROUND: Low case volume has been associated with poorer surgical outcomes in a multitude of surgical procedures. We studied the association among low case volume, outcomes, and the likelihood of pediatric liver transplantation. METHODS: We studied a cohort of 6628 candidates listed in the Organ Procurement and Transplantation Network for primary pediatric liver transplantation between 2002 and 2012; 4532 of the candidates went on to transplantation. Candidates were divided into groups according to the average volume of yearly transplants performed in the listing center over 10 years: >15, 10 to 15, 5 to 9, and <5. We used univariate and multivariate Cox regression analyses with bootstrapping on transplant recipient data and identified independent recipient and donor risk factors for wait-list and posttransplant mortality. RESULTS: 38.5% of the candidates were listed in low-volume centers, those in which <5 transplants were performed annually. These candidates had severely reduced likelihood of transplantation with only 41% receiving a transplant. For the remaining candidates, listed at higher volume centers, the transplant rate was 85% (P < .001). Being listed at a low-volume center was a significant risk factor in multivariate Cox regression analysis for both wait-list mortality (hazard ratio, 3.27; confidence interval, 2.53-4.23) and posttransplant mortality (hazard ratio, 2.21; confidence interval, 1.43-3.40). CONCLUSIONS: 38.5% of pediatric transplant candidates are listed in low-volume transplant centers and have lower likelihood of transplantation and poorer outcomes. If further studies substantiated these findings, we would advocate consolidating pediatric liver transplantation in higher volume centers.