Contemporary National Incidence and Outcomes of Acute Limb Ischemia.

BACKGROUND: Acute limb ischemia (ALI) is a morbid and deadly diagnosis. However, existing epidemiologic studies describing ALI predate the introduction of the Affordable Care Act in 2010 and direct oral anticoagulants in 2011. Thus, we synergized the National Inpatient Sample (NIS) and United States Census to define contemporary trends in the incidence, treatment, and outcomes of ALI in the US. METHODS: We included emergent admissions of adults with primary diagnosis of lower extremity ALI in survey-weighted NIS data (2005-2020). Mann-Kendal trend test evaluated ALI incidence (primary outcome), anticoagulation usage, insurance coverage, revascularization type, and in-hospital amputation/death. Multivariable logistic regression quantified covariate associations with in-hospital amputation/death. RESULTS: Of the 582,322,862 estimated hospitalizations in the NIS, 227,440 met the inclusion criteria (mean age 68.80 years, 49.94% women, 76.66% White). ALI incidence peaked in 2006 (7.16/100,000 person-years) but has declined since 2015 to 4.16/100,000 person-years in 2020 (ptrend = 0.008). Endovascular revascularization, anticoagulation, and Medicaid coverage increased, while self-pay insurance decreased (ptrend < 0.05). Amputation rates significantly decreased from 8.04 to 6.54% (ptrend = 0.01) while death rate remained at 5.59% (ptrend = 0.16) over the study period. Prehospitalization anticoagulation was associated with decreased amputation (adjusted odds ratio [aOR] = 0.74 (95% confidence interval [CI] 0.65-0.84)) and death (aOR = 0.50 (95% CI 0.43-0.57)). When controlling for covariates, women had a higher risk of death (aOR = 1.17 (95% CI 1.07-1.27), P < 0.0001), while Black patients had a higher risk of amputation (aOR = 1.24 (95% CI 1.10-1.41), P < 0.0001). CONCLUSIONS: Our US population based epidemiological study demonstrates that ALI incidence and in-hospital amputation rates are decreasing, while mortality remains unchanged. We further highlight the ongoing need for ALI investigation specifically as it relates to access to care, antithrombotic therapy use, treatment strategy, and strategies to combat gender and racial disparities.

Selective Publication within Vascular Surgery: Characteristics of Discontinued and Unpublished Randomized Clinical Trials.

BACKGROUND: Discontinued and unpublished randomized clinical trials (RCTs) are common resulting in biased publication and loss of potential knowledge. The magnitude of selective publication within vascular surgery remains unknown. METHODS: RCT relevant to vascular surgery registered (01/01/2010-10/31/2019) on ClinicalTrials.gov were included. Trials ending normally with conclusion of participant treatment and examination were considered completed whereas discontinued trials stopped early. Publications were identified through automatically indexed PubMed citations on ClinicalTrials.gov or manually identified on PubMed or Google Scholar >30 months after the completion date, the date the final participant was examined, allowing time for publication. RESULTS: Of 108 RCT (n = 37, 837), 22.2% (24/108) were discontinued, including 16.7% (4/24) stopped prior to and 83.3% (20/24) after starting enrollment. Only 28.4% of estimated enrollment was achieved for all discontinued RCT. Nineteen (79.2%) investigators provided a reason for discontinuation, which most commonly included poor enrollment (45.8%), inadequate supplies or funding (12.5%), and trial design concerns (8.3%). Of the 20 trials terminated following enrollment, 20.0% (4/20) were published in peer-reviewed journals and 80.0% (16/20) failed to reach publication. Of the 77.8% trials completed, 75.0% (63/84) were published and 25.0% (21/84) remain unpublished. In a multivariate regression of completed trials, industry funding was significantly associated with decreased likelihood of peer-reviewed publication (OR = 0.18, (95% CI 0.05-0.71), P = 0.01). Of the discontinued and completed trials remaining unpublished, 62.5% and 61.9% failed to report results on ClinicalTrials.gov, respectively, encompassing a total of 4,788 enrollees without publicly available results. CONCLUSIONS: Nearly 25% of registered vascular RCT were discontinued. Of completed RCT, 25% remain unpublished with industry funding associated with decreased likelihood of publication. This study identifies opportunities to report all findings for completed and discontinued vascular surgery RCT, whether industry sponsored, or investigator initiated.

Adductor canal syndrome after lesser trochanter avulsion fracture in a 19-year-old.

A rare cause of limb ischemia in young patients, adductor canal syndrome, can be debilitating and result in functional impairment. Diagnosis and treatment may be delayed due to this vascular disease's rarity in young people and because the presenting symptoms can overlap with other more common causes of leg pain in young athletes. Here, authors discuss a young athletic patient with a history of year-long claudication. The patient's reported symptoms, exam findings, and imaging results were consistent with a diagnosis of adductor canal syndrome. This case proved uniquely challenging, given the extent of disease and illustrates potential approach considerations.

Stenting performs better than drug-coated balloon angioplasty in popliteal lesions.

BACKGROUND: Peripheral arterial disease (PAD) is a common and highly morbid disease. Although there have been recent advancements in the endovascular modalities to treat PAD, comparisons of these strategies, especially in the popliteal region, remain underinvestigated. The objective of this study was to compare midterm outcomes in patients with PAD undergoing treatment with both novel and SS compared with drug-coated balloon (DCB) angioplasty. METHODS: All patients at a multi-institution health system treated for PAD in the popliteal region from 2011 to 2019 were identified. Presenting features, operative details, and outcomes were included in the analysis. Patients who underwent popliteal revascularization with stents were compared with DCB. SS were compared separately with novel dedicated stents. Two-year primary patency was the primary outcome. RESULTS: We included 408 patients (72.7 ± 11.8 years old; 57.1% men) in the analysis. There were 221 (54.7%) patients who underwent popliteal stenting and 187 (45.3%) who underwent popliteal DCB. There were high rates of tissue loss in both groups (57.9% vs 50.8%; P = .14). Stented patients had longer lesions (112.4 ± 3.2 vs 100.2 ± 5.8 mm; P = .03) and higher rates of concomitant superficial femoral artery treatment (88.2% vs 39.6%; P < .01). Chronic total occlusions accounted for the majority of lesions treated (stent 62.4%, DCB 64.2%). Perioperative complications were similar between groups. Primary patency for the stented group was higher at two years than the DCB group (61.0% vs 46.1%; P = .03). When evaluating stented patients only, SS had higher 2-year patency than novel stents in the popliteal segment (69.6% vs 51.4%; P = .04). On multivariable analysis, stenosis, as opposed to chronic total occlusion, was associated with improved patency (hazard ratio, 0.49; 95% confidence interval, 0.25-0.96; P = .04), whereas novel stents were associated with worse primary patency (hazard ratio, 2.01; 95% confidence interval, 1.09-3.73; P = .03). CONCLUSIONS: In a population of patients with severe vascular disease, stents do not have inferior patency and limb salvage rates compared with DCB angioplasty when treating the popliteal region. For patients with advanced vascular disease, and especially tissue loss, stents and DCB are both beneficial when treating popliteal lesions.

Acute limb ischemia secondary to vaccine-induced thrombotic thrombocytopenia.

Vaccine-associated thrombosis has previously been described in patients presenting with cerebral sinus thrombosis, deep venous thrombosis/pulmonary embolism, or mesenteric venous thrombosis. Only recently has arterial thrombosis gained attention. A new entity known as vaccine-induced thrombotic thrombocytopenia (VITT) has been associated with the coronavirus disease of 2019 (COVID-19) vaccines produced by AstraZeneca and Johnson & Johnson. We describe a case series of three patients who presented with acute limb ischemia with vaccine-associated arterial occlusions, one of whom was diagnosed with VITT.

Improved outpatient medical visit compliance with sociodemographic discrepancies in vascular telehealth evaluations.

OBJECTIVE: The COVID-19 (coronavirus disease 2019) pandemic has led to a rapid expansion in the use of telemedicine across all medical fields but has also exposed telehealth care disparities with differing access to technology across racial and ethnic groups. The objective of our study was to investigate the effects of telehealth on vascular visit compliance and to explore the effects of sociodemographic factors on vascular surgery outpatient telehealth usage during the COVID-19 pandemic. METHODS: Consecutive patients who had undergone an outpatient vascular surgery evaluation between February 24, 2020 (the launch of our telemedicine program) and December 31, 2020, were reviewed. The baseline demographic and outcomes were obtained from the electronic medical records. Telehealth and in-person evaluations were defined according to the patient's index visit during the study period. Medical visit compliance was established on completion of the telehealth or in-person encounter. We used χ2 tests and logistic regression analyses. RESULTS: A total of 23,553 outpatient visits had been scheduled for 10,587 patients during the study period. Of the outpatient visits, 1559 had been scheduled telehealth encounters compared with 21,994 scheduled in-person encounters. Of the scheduled outpatient encounters, 13,900 medical visits (59.0%) had been completed: 1183 telehealth visits and 12,717 in-person visits. The mean travel distance saved for the telehealth visits was 22.1 ± 27.1 miles, and the mean travel time saved was 46.3 ± 41.47 minutes. We noted no sociodemographic differences between the patients scheduled for telehealth vs in-person visits. We found a trend toward a lower proportion of African-American patients in the telehealth group vs the in-person group (7.8% vs 10.6%; P = .116), without statistical significance. A significantly higher rate of medical visit completion was found for the telehealth group compared with the in-person group (79.5% vs 59.4%; P < .001). Among the patients scheduled for an outpatient medical visit, a scheduled telemedicine evaluation (vs in-person) was associated with 2.3 times the odds of completing the medical visit (odds ratio, 2.31; 95% confidence interval, 2.05-2.61), adjusting for age, sex, race, ethnicity, language, and the distance between the patient's home zip code and the outpatient vascular center's zip code. Selecting for scheduled telemedicine visits, African-American race was associated with a decreased odds of telemedicine usage (odds ratio, 0.73; 95% confidence interval, 0.59-0.90) after adjusting for age, sex, ethnicity, language, and visit type. CONCLUSIONS: Use of the vascular surgery outpatient telehealth evaluation appeared to improve medical visit completion in our region with apparent sociodemographic disparities. Further studies are needed to confirm whether telemedicine expansion has improved access to care in other geographic areas.

Improved long-term outcomes with catheter-directed therapies over medical management in patients with submassive pulmonary embolism-a retrospective matched cohort study.

BACKGROUND: The benefit of catheter-directed therapy (CDT) for submassive pulmonary embolism (sPE) has been the subject of debate. We sought to determine the short- and long-term mortality and outcomes of CDT compared with anticoagulation for patients with sPE. METHODS: We performed a single healthcare network, multihospital, retrospective cohort study of hospitalizations for sPE from 2012 to 2019. sPE was defined as the presence of right heart strain or elevated biomarkers (troponin I or B-type natriuretic peptide). Patients with massive PE and those who had undergone systemic thrombolysis were excluded. The sPE groups included therapeutic anticoagulation alone or anticoagulation plus CDT (ie, thrombolysis or suction thrombectomy). The primary outcome was mortality at 1, 3, and 5 years. The other measured outcomes included PE-related death, short term mortality (30 days and 3 and 6 months), 30-day treatment-related complications (eg, bleeding, transfusion, stroke), chronic thromboembolic pulmonary hypertension, and 6-minute walk test at 1 year. After 1:1 nearest-neighbor propensity score matching, Kaplan-Meier survival plots were generated, and the treatment groups were compared using log-rank testing. We used Cox multivariate analysis to evaluate the outcomes after clustering at the hospital level, generating matched hazard ratios (mHRs) with associated 95% confidence intervals (CIs). RESULTS: Of 6746 sPE hospitalizations, the patients who had received CDT were younger (age, 58.9 ± 15.5 years vs 61.5 ± 17.4 years; P = .004), were more frequently White (92.5% vs 85.7%; P < .001), and had presented with a higher mean heart rate (104.6 bpm vs 94.9 bpm; P < .001), lower median systolic blood pressure (129 mm Hg vs 135 mm Hg; P < .001), and a greater incidence of right heart strain (79.2% vs 20.3%; P < .001). A total of 470 patients were matched, with 235 in the CDT group and 235 in the anticoagulation-only group. CDT was associated with a lower risk of mortality compared with anticoagulation at 1 year (7.6% vs 9.8%; mHR, 0.77; 95% CI, 0.65-0.92; P = .004), 3 years (11.1% vs 16.6%; mHR, 0.64; 95% CI, 0.55-0.73; P < .001), and 5 years (14.5% vs 19.1%; mHR, 0.71; 95% CI, 0.66-0.77; P < .001). Anticoagulation alone resulted in a greater incidence of PE-related deaths at 1, 3, and 5 years. The mortality at 30 days and 3 months was similar; however, CDT had resulted in better survival at 6 months (mHR, 0.81; 95% CI, 0.68-0.97; P = .02). No differences were found between the two groups in the incidence of bleeding complications at 30 days, development of chronic thromboembolic pulmonary hypertension, or the mean walking distance at 1 year. CONCLUSIONS: CDT plus anticoagulation for sPE was associated with improved long-term survival compared with anticoagulation alone, with a lower incidence of PE-related death and a low complication rate. CDT should be considered for select patients with sPE given its survival benefit.

Alternative autologous and biologic conduits have worse outcomes than prosthetic grafts for infrainguinal bypass in patients with chronic limb-threatening ischemia.

OBJECTIVE: Single segment great saphenous vein (GSV) is the preferred conduit in infrainguinal bypass. Alternative autologous conduits (AAC) and nonautologous biologic conduits (NABC) are thought to be a better alternative to traditional prosthetic conduits (PC) in the absence of GSV. In this study we analyzed the outcomes of these alternative conduits in lower extremity bypasses (LEB) in patients with chronic limb-threatening ischemia. METHODS: The Vascular Quality Initiative LEB database from 2003 to 2020 was queried for this study, to identify LEB in patients with chronic limb-threatening ischemia. Primary outcomes were graft patency, major adverse limb events (MALE), and MALE-free survival at 1 year. Standard statistical methods were used as appropriate. RESULTS: We identified 22,671 LEB procedures (12,810 GSV, 6002 PC, 1907 AAC, and 1952 NABC). Compared with the GSV group, the other conduit patients were significantly older, had more comorbidities, had an increased rate of prior lower extremity interventions, had a higher rate of infrageniculate bypass targets, and were less ambulatory at baseline. The PC, AAC, and NABC groups had significantly higher rates of postoperative morbidity compared with the GSV group. The PC group had a higher 30-day mortality compared with the GSV, AAC, and NABC groups (3% PC vs 2% GSV, 2% AAC, 2% NABC; P = .049). Both PC and NABC had higher 1-year mortality compared with GSV and AAC (13% PC and 13% NABC vs 10% GSV, 10% AAC; P = .02). In an adjusted Cox regression model (stratified by infrageniculate target and adjusted for age, comorbidities, and prior vascular interventions) PC was not significantly different from GSV, but AAC (hazard ratio [HR], 1.41; 95% confidence interval [CI], 1.19-1.67; P < .001) and NABC (HR, 1.9; 95% CI, 1.61-2.25; P < .001) were associated with an increased risk of loss of primary patency. A similar association with MALE was observed: both AAC (HR, 1.35; 95% CI, 1.15-1.58; P < .001) and NABC (HR, 1.8; 95% CI, 1.53-2.11; P < .001) were associated with an increased risk of MALE compared with GSV; PC was not significantly different from GSV. CONCLUSIONS: In the absence of GSV, alternative conduits (autologous or nonautologous biologic) do not confer a benefit with regard to graft patency or MALE compared with PCs. Increased operating time or costs associated with the use of these conduits is not justified based on this study.

A systematic review of cognitive function after carotid endarterectomy in asymptomatic patients.

OBJECTIVE: Asymptomatic carotid stenosis has been associated with a progressive decline in neurocognitive function. However, the effect of carotid endarterectomy (CEA) on this process is poorly understood. We aimed to evaluate preoperative and postoperative cognitive function changes in asymptomatic patients after CEA. METHODS: A systematic review of the existing reports in PubMed/MEDLINE, Embase, and Cochran databases was conducted according to the Preferred Reporting Items for Systematic Reviews and Meta-analysis statement recommendations. All original retrospective or prospective studies (including cohort, cross-sectional, case-control, pilot studies, etc) and clinical trials that compared pre and postoperative neurocognitive function in asymptomatic patients with carotid stenosis after CEA, which were published from January 2000 to April 2021 were identified and considered eligible for inclusion in the study. RESULTS: Thirteen studies (502 CEAs) comparing cognitive function changes before and after CEA were identified. In 7 studies with a total 272 patients, a mean age range of 67.3 ± 4.8 to 76.35 years old, and follow-up ranging between 1 and 12 months, overall cognitive function improved after CEA. However, in 6 studies with a total sample of 230, a mean age range of 68.6 ± 6.9 to 74.4 ± 6.1 years, and follow-up ranged from 24 hours to 3 years, showed no change or decline in overall cognitive function after procedures. CONCLUSIONS: The lack of standardization of specific cognitive tests and cognitive function assessment timing after CEA does not allow for definite conclusions to be made. However, improving brain perfusion with a combination of CEA and statin therapy may be a protective strategy against cognitive function decline.

Hospital-based delays to revascularization increase risk of postoperative mortality and short bowel syndrome in acute mesenteric ischemia.

OBJECTIVE: Acute mesenteric ischemia (AMI) is a surgical emergency for which delays in treatment have been closely associated with high morbidity and mortality. Although the duration of ischemia as a determinant of outcomes for AMI is well known, the objective of this study was to identify hospital-based determinants of delayed revascularization and their effects on postoperative morbidity and mortality in AMI. METHODS: All patients who underwent any surgery for AMI from a multi-center hospital system between 2010 and 2020 were divided into two groups based on timeliness of mesenteric revascularization after presentation. Early revascularization (ER) was defined as having both vascular consultation ≤12 hours of presentation and vascular surgery performed at the patient's initial operation. Delayed revascularization (DR) was defined as having either delays to vascular consultation or vascular surgery. A retrospective review of demographic and postoperative data was performed. The effect of DR on major postoperative outcomes, including 30-day and 2-year mortality, total length of bowel resection, and development of short bowel syndrome, were analyzed. Effects of delayed vascular consultation alone, delayed vascular surgery alone, no revascularization during admission, and admitting service on outcomes were also examined on subgroup analyses. RESULTS: A total of 212 patients were analyzed. Ninety-nine patients received ER, whereas the remaining 113 patients experienced a DR after hospital presentation. Among the DR group, 55 patients (25.9%) had delayed vascular consultation, whereas vascular surgery was deferred until after the initial operation in 37 patients (17.4%). Fifty-one patients (24.0%) were never revascularized during admission. DR was a significant predictor of 30-day (odds ratio [OR], 2.09; 95% confidence interval [CI], 1.4-4.9; P = .03) and 2-year mortality (hazard ratio, 1.55, 95% CI, 1.0-2.3; P = .04). DR was also independently associated with increased bowel resection length (OR, 7.47; P < .01) and postoperative short bowel syndrome (OR, 2.4; P = .03) on multivariate analyses. When examined separately on subgroup analysis, both delayed vascular consultation (OR, 3.38; P = .03) and vascular surgery (OR, 4.31; P < .01) independently increased risk of 30-day mortality. Hospital discharge after AMI without mesenteric revascularization was associated with increased risk of short bowel syndrome (OR, 2.94; P < .01) and late mortality (hazard ratio, 1.60; P = .04). CONCLUSIONS: Delayed vascular consultation and vascular surgery are both significant hospital-based determinants of postoperative mortality and short bowel syndrome in patients with AMI. Timing-based management protocols that emphasize routine evaluation by a vascular surgeon and early, definitive mesenteric revascularization should be established and widely adopted for all patients with clinically suspected AMI at presentation.

Institutional trends over a decade in catheter-directed interventions for pulmonary embolism.

OBJECTIVE: Catheter-directed interventions (CDIs) are commonly performed for acute pulmonary embolism (PE). The evolving catheter types and treatment algorithms impact the use and outcomes of these interventions. This study aimed to investigate the changes in CDI practice and their impact on outcomes. METHODS: Patients who underwent CDIs for PE between 2010 and 2019 at a single institution were identified from a prospectively maintained database. A PE team was launched in 2012, and in 2014 was established as an official Pulmonary Embolism Response Team. CDI annual use trends and clinical failures were recorded. Clinical success was defined as physiologic improvement in the absence of major bleeding, perioperative stroke or other procedure-related adverse event, decompensation for submassive or persistent shock for massive PE, the need for surgical thromboembolectomy, or death. Major bleeding was defined as requiring a blood transfusion, a surgical intervention, or suffering from an intracranial hemorrhage. RESULTS: There were 372 patients who underwent a CDI for acute PE during the study period with a mean age of 58.9 ± 15.4 years; there were males 187 (50.3%) and 340 patients has a submassive PE (91.4%). CDI showed a steep increase in the early Pulmonary Embolism Response Team years, peaking in 2016 with a subsequent decrease. Ultrasound-assisted thrombolysis was the predominant CDI technique peaking at 84% of all CDI in 2014. Suction thrombectomy use peaked at 15.2% of CDI in 2019. The mean alteplase dose with catheter thrombolysis techniques decreased from 26.8 ± 12.5 mg in 2013 to 13.9 ± 7.5 mg in 2019 (P < .001). The mean lysis time decreased from 17.2 ± 8.3 hours in 2013 to 11.3 ± 8.2 hours in 2019 (P < .001). Clinical success for the massive and the submassive PE cohorts was 58.1% and 91.2%, respectively; the major bleed rates were 25.0% and 5.3%. There were two major clinical success peaks, one in 2015 mirroring our technical learning curve and one in 2019 mirroring our patient selection learning curve. The clinical success decrease in 2018 was primarily derived from blood transfusions owing to acute blood loss during suction thrombectomy. CONCLUSIONS: CDIs for acute PE have rapidly evolved with high success rates. Multidisciplinary approaches among centers with appropriate expertise are advisable for the safe and successful implementation of catheter interventions.