Cost-effectiveness analysis of endovascular vs surgical arteriovenous fistula creation in the United States.

OBJECTIVE: In the United States, an estimated $2.8 billion annually is spent on vascular access and its complications. Endovascular arteriovenous fistula (endoAVF) creation is a novel, minimally invasive alternative to traditional surgical AV fistula (sAVF) creation in ≤60% of patients. Although cost effective in single-payer systems, the clinical and financial impact of endoAVF in the United States remains uncertain. METHODS: We constructed a decision tree followed by a probabilistic cohort state-transition model to study the cost effectiveness of endoAVF vs sAVF creation. We conducted a systematic review to obtain input parameters including technical success, maturation, patency, and utility values. We derived costs from the Medicare 2022 fee schedule and from the literature. We used a 5-year time horizon, an annual discount rate of 3% for costs and utilities (measured in quality-adjusted life-years [QALYs]), and the common willingness-to-pay threshold of $50,000. One-way and Monte Carlo probabilistic sensitivity analyses were performed varying technical success, patency, reintervention, cost, and utility parameters. RESULTS: In the base-case scenario, endoAVF ($30,129 average per-person costs, 2.19 QALYs gained, 65% patent at 5 years) was not cost effective compared with sAVF ($12.987 average per-person costs, 2.11 QALYs gained, 66% patent at 5 years), generating an incremental cost-effectiveness ratio of $227,504 per QALY gained. In one-way sensitivity analyses, endoAVF becomes cost effective when the initial cost of sAVF creation exceeds endoAVF by ≥$600 (eg, if endoAVF creation costs ≤$3000 relative to the base-case sAVF cost of $3600), the additional QALYs gained from endoAVF exceeds 0.12 QALYs/year (eg, 0.81 QALYs gained/year from endoAVF compared with base-case sAVF 0.69 QALYs/year), the endoAVF maturation rate is >90% (base case 78%), or the sAVF maturation rate is <65% (base case 78%). Probabilistic sensitivity analysis demonstrated that sAVF remained the optimal strategy in 71% of iterations. CONCLUSIONS: EndoAVF is not cost effective compared with sAVF when modeling 5-year outcomes. The main driver of sAVF remaining cost effective is the four times higher up-front cost for endoAVF creation, as well as a relatively low additional increase in quality of life for endoAVF. It will be important to establish how the endoAVF learning curve contributes to upfront costs and, given the annual cost attributed to vascular access nationally, a randomized controlled trial is warranted.

Utilizing remote access for electronic medical records reduces overall electronic medical record time for vascular surgery residents.

OBJECTIVE: Survey data suggests that surgical residents spend 20% to 30% of training time using the electronic medical record (EMR), raising concerns about burnout and insufficient operative experience. We characterize trainee EMR activity in the vascular surgery service of a quaternary care center to identify modifiable factors associated with high EMR use. METHODS: Resident activity while on the vascular surgery service was queried from the EMR. Weekends and holidays were excluded to focus on typical staffing periods. Variables including daily time spent, post-graduate year (PGY), remote access via mobile device or personal laptop, and patient census including operative caseload were extracted. Univariate analysis was performed with t tests and χ2 tests where appropriate. We then fit a linear mixed-effects model with normalized daily EMR time as the outcome variable, random slopes for resident and patient census, and fixed effects of PGY level, academic year, and fractional time spent using remote access. RESULTS: EMR activity for 53 residents from July 2015 to June 2019 was included. The mean daily EMR usage was 1.6 hours, ranging from 3.6 hours per day in PGY1 residents to 1.1 hours in PGY4 to 5 residents. Across all PGYs, the most time-consuming EMR activities were chart review (43.0%-46.6%) and notes review (22.4%-27.0%). In the linear mixed-effects model, increased patient census was associated with increased daily EMR usage (Coefficient = 0.61, P-value < .001). Resident seniority (Coefficient = -1.2, P-value < .001) and increased remote access (Coefficient = -0.44, P-value < .001) were associated with reduced daily EMR usage. Over the study period, total EMR usage decreased significantly from the 2015/2016 academic year to the 2018/2019 academic year (mean difference, 2.4 hours vs 1.78; P-value < .001). CONCLUSIONS: In an audit of EMR activity logs on a vascular surgery service, mean EMR time was 1.6 hours a day, which is lower than survey estimates. Resident seniority and remote access utilization were associated with reduced time spent on the EMR, independent of patient census. Although increasing EMR accessibility via mobile devices and personal computers have been hypothesized to contribute to poor work-life balance, our study suggests a possible time-saving effect by enabling expedient access for data review, which constitutes the majority of resident EMR activity. Further research in other institutions and specialties is needed for external validation and exploring implications for resident wellness initiatives.

Most privately insured patients do not receive federally recommended abdominal aortic aneurysm screening.

OBJECTIVE: Since 2005, the United States Preventative Services Task Force has recommended abdominal aortic aneurysm (AAA) ultrasound screening for 65- to 75-year-old male ever-smokers. Integrated health systems such as Kaiser Permanente and the Veterans Affairs (VA) health care system report 74% to 79% adherence, but compliance rates in the private sector are unknown. METHODS: The IBM Marketscan Commercial and Medicare Supplemental databases (2006-2017) were queried for male ever-smokers continuously enrolled from age 65 to 75 years. Exclusion criteria were previous history of AAA, connective tissue disorder, and aortic surgery. Patients with abdominal computed tomographic or magnetic resonance imaging from ages 65 to 75 years were also excluded. Screening was defined as a complete abdominal, retroperitoneal, or aortic ultrasound. A logistic mixed-effects model utilizing state as a random intercept was used to identify patient characteristics associated with screening. RESULTS: Of 35,154 eligible patients, 13,612 (38.7%) underwent screening. Compliance varied by state, ranging from 24.4% in Minnesota to 51.6% in Montana (P < .05). Screening activity increased yearly, with 0.7% of screening activity occurring in 2008 vs 22.2% in 2016 (P <.05). In a logistic mixed-effects model adjusting for state as a random intercept, history of hypertension (odds ratio [OR], 1.07; 95% confidence interval [CI], 1.03-1.13), coronary artery disease (OR, 1.17; 95% CI, 1.10-1.22), congestive heart failure (OR, 1.14; 95% CI, 1.01-1.22), diabetes (OR, 1.1; 95% CI, 1.06-1.16), and chronic kidney disease (OR, 1.4; 95% CI, 1.24-1.53) were associated with screening. Living outside of a census-designated metropolitan area was negatively associated with screening (OR, 0.92; 95% CI, 0.87-0.97). CONCLUSIONS: In a private claims database representing 250 million claimants, 38.7% of eligible patients received United States Preventative Services Task Force-recommended AAA screening. Compliance was nearly one-half that of integrated health systems and was significantly lower for patients living outside of metropolitan areas. Efforts to improve early detection of AAA should include targeting non-metropolitan areas and modifying Medicare reimbursement and incentivization strategies to improve guideline adherence.

Association of Baseline Chronic Kidney Disease Stage With Short- and Long-Term Outcomes After Fenestrated Endovascular Aneurysm Repair.

BACKGROUND: Fenestrated endovascular aneurysm repair (FEVAR) is a well-established treatment approach for juxtarenal and short-neck infrarenal aortic aneurysms. Recommendations and clinical outcomes are lacking for offering FEVAR in patients with chronic kidney disease (CKD). We aimed to compare short- and long-term outcomes for patients with none-to-mild versus moderate-to-severe CKD undergoing FEVAR. METHODS: We retrospectively reviewed consecutive patients undergoing standard FEVAR with Cook devices at a single institution. The cohort was stratified by preoperative CKD stage none-to-mild or moderate-to-severe (CKD 1-2 and CKD 3-5, respectively). The primary outcome was postoperative acute kidney injury (AKI). Secondary outcomes included 30-day perioperative complications, 1- and 5-year rates of overall survival, dialysis, renal target artery patency, endoleak, and reintervention assessed by the Kaplan-Meier method. Aneurysm sac regression, number of surveillance computed tomography (CT) scans, and CKD stage progression were assessed at latest follow-up. Multivariate Cox proportional hazards modeling was used to evaluate the association of CKD stage 3 and stage 4-5 with all-cause mortality, controlling for differences in baseline characteristics. RESULTS: From 2012- to 2022, 184 patients (of which 82% were male) underwent FEVAR with the Cook ZFEN device (mean follow-up 34.3 months). Group CKD 3-5 comprised 77 patients (42%), was older (75.2 vs. 73.0 years, P = 0.04), had increased preoperative creatinine (1.6 vs. 0.9 mg/dL, P < 0.01), and demonstrated increased renal artery ostial calcification (37.7% vs. 21.5%, P = 0.02) compared with Group CKD 1-2. Perioperatively, CKD 3-5 sustained higher estimated blood loss (342 vs. 228 ml, P = 0.01), longer operative times (186 vs. 162 min, P = 0.04), and longer length of stay (3 vs. 2 days, P < 0.01). Kaplan-Meier 1- and 5-year survival estimates were lower for CKD 3-5 (82.3% vs. 95.1%, P < 0.01 and 55.4% vs. 70.8%, P = 0.02). Fewer CKD 3-5 patients remained free from chronic dialysis at 1 year (94.4% vs. 100%, P = 0.015) and 5 years (84.7% vs. 100%, P < 0.01). There were no significant differences in postoperative AKI rate (CKD 1-2 6.5% vs. CKD 3-5 14.3%, P = 0.13), long-term renal artery patency, reinterventions, type I or III endoleak, mean sac regression, or total follow-up CT scans between groups. CKD stage progression occurred in 47 patients (31%) at latest follow-up but did not differ between stratified groups (P = 0.17). On multivariable modeling, age (hazard ratio 1.05, 95% confidence interval 1.01-1.09, P = 0.02) and CKD stage 4-5 (hazard ratio 6.39, 95% confidence interval 2.26-18.05, P < 0.01) were independently associated with mortality. CONCLUSIONS: Preoperative CKD status did not negatively impact the durability or technical success related to aneurysm outcomes after FEVAR. Worsening CKD stage was associated with lower 1- and 5-year overall survival and freedom from dialysis after FEVAR with no statistically significant differences in 30-day or long-term technical aneurysm outcomes.

Impact of Scalene Muscle Botulinum Toxin Injection With and Without Surgery in Neurogenic Thoracic Outlet Syndrome.

OBJECTIVE: Scalene blocks are part of both the diagnostic and treatment algorithm for patients presenting with symptoms of neurogenic thoracic outlet syndrome (nTOS). However, there is a paucity of data on the utility of scalene botulinum toxin injection (BTI) before surgical decompression. We sought to determine the impact of BTI with and without surgery at a multidisciplinary referral center. DESIGN: Retrospective cohort study. SETTING: Single institution tertiary academic center, 2011 to 2020. PATIENTS: Seventy-seven consecutive patients. INTERVENTIONS: Scalene muscle BTI for nTOS with or without surgical decompression. MAIN OUTCOME MEASURES: Pain relief and Quick Disability of the Arm, Shoulder and Hand (QDASH) score. RESULTS: Seventy-seven patients, with a mean age of 31.4 years, had BTI for symptoms of nTOS. All patients underwent pretreatment physical therapy through the Edgelow protocol for a mean duration of 3.4 months. However, 72.7% had dynamic vascular compression on duplex ultrasound with provocative maneuvers and 85.7% had a positive physical examination finding. After BTI, 77.9% reported subjective relief, confirmed by an improved QDASH disability score. Thirty-one patients (40.3%) then went on to have further persistent symptoms and proceeded with first rib resection. After BTI + Surgery, 96.8% reported symptomatic relief and had a median QDASH score improvement of 21 (range: 10-40), with all reaching minimal clinically important differences in the QDASH score after combination therapy. CONCLUSIONS: In this reported series of chemodenervation in patients with nTOS, BTI is helpful in alleviating symptoms before definitive surgical decompression. BTI followed by first rib resection provides additional symptom improvement over BTI alone.

Trends in annual open abdominal aortic surgical volumes for vascular trainees compared with annual national volumes in the endovascular era.

OBJECTIVE: A prior analysis predicted a shortfall in open abdominal aortic repair (OAR) experience for vascular trainees resulting from the rapid adoption, and increased anatomic suitability, of endovascular aortic aneurysm repair (EVAR) technology. We explored how EVAR has transformed contemporary open aortic surgical education for vascular trainees. METHODS: We examined the Accreditation Council for Graduate Medical Education case volumes of open abdominal aortic aneurysm (AAA) repair and reconstruction for aortoiliac occlusive disease via aortoiliac or femoral bypass (AFB) from integrated vascular surgery residents (VSRs) and fellows (VSFs) graduating from 2006 to 2017 and compared them to the national estimates of total OAR (open AAA repair plus AFB) in the Agency for Healthcare Research and Quality National Inpatient Sample using the International Classification of Diseases, 9th and 10th revision, procedural codes. Changes over time were assessed using the χ2 test, Student's t test, and linear regression. RESULTS: During the 12-year study period, the national annual total OAR and open AAA repair estimates had decreased: total OAR by 72.5% (estimate ± standard error: 2006, 24,255 ± 1185; vs 2017, 6690 ± 274; P < .001) and open AAA repair by 84.7% (estimate ± standard error: 2006, 18,619 ± 924; vs 2017, 2850 ± 168; P < .001). The AFB estimates had decreased by 33.0% (P < .001). The percentage of total OAR, open AAA repair, and AFB performed at teaching hospitals had significantly increased, from ∼55% to 80% (P < .001 for all). A 40.9% decrease was found for open AAA repairs performed by graduating VSFs (mean, 18.6 vs 11) but only a 6.9% decrease in total OAR cases (mean, 27.6 vs 25.7) owing to increasing AFB volumes (mean, 9.0 vs 14.7). The VSR graduates had consistently logged an average of ∼10 open AAA repairs, with a 31.0% increase in total OARs (mean, 23.2 vs 30.4), again secondary to increasing AFB volumes (mean, 11.4 vs 17.5). Although an absolute decrease was found in open aortic experience for VSFs, the rate of decline for the total OAR case volumes was not significantly different after VSR programs had been established (P = .40). CONCLUSIONS: As the incidence has decreased nationally, the use of OAR has been shifting toward teaching hospitals. Although open AAA procedures for trainees have been declining with the increased use of EVAR, open aortic reconstruction for aortoiliac occlusive disease has been increasing, playing an important role in ensuring that vascular trainees continue to have satisfactory OAR experience sufficient for meeting minimum graduation requirements. Strategies to maintain and maximize the education and experience from these cases should be the top priority for vascular surgery program directors.

Cost-effectiveness of computed tomography versus ultrasound-based surveillance following endovascular aortic repair of intact infrarenal abdominal aortic aneurysms.

BACKGROUND: While Society for Vascular Surgery guidelines recommend computed tomography angiography (CTA) or ultrasound for surveillance following infrarenal endovascular aortic repair (EVAR), there is a lack of consensus regarding optimal timing and modalities. We hypothesized that ultrasound-based approaches would be more cost-effective and developed a cost-effectiveness analysis to estimate the lifetime costs and outcomes of various strategies. METHODS: We developed a decision tree with nested Markov models to compare five surveillance strategies: yearly CTA, yearly CDU, yearly CEU, CTA at first year followed by CDU, and CTA at first year followed by CEU. The model accounted for differential sensitivity, specificity, and risk of acute kidney injury after CTA, and was implemented on a monthly cycle with a willingness-to-pay threshold of $50,000 per quality-adjusted life year (QALY) and 3% annual discounting. RESULTS: Under base case assumptions, the CTA-CDU strategy was cost effective with a lifetime cost of $77950 for 7.74 QALYs. In sensitivity analysis, the CTA-CDU approach remained cost-effective when CEU specificity was less than 95%, and risk of acute kidney injury following CTA was less than 20%. At diagnostic sensitivities below 75% for CEU and 55% for CDU, a yearly CTA strategy maximized QALYs. CONCLUSIONS: A hybrid strategy in which CTA is performed in the first year and CDU is performed annually thereafter is the most cost-effective strategy for infrarenal EVAR surveillance in patients with less than a 20% risk of contrast-induced nephropathy. If the sensitivity of CEU and CDU are at the lower end of plausible estimates, a yearly CTA strategy is reasonable. Further research should aim to identify patients who may benefit from alternative surveillance strategies.

Female sex is independently associated with in-hospital mortality after endovascular aortic repair for ruptured aortic aneurysm.

BACKGROUND: Endovascular aortic repair (EVAR) can treat anatomically compatible ruptured abdominal aortic aneurysms (rAAA), but registry data suggests that women undergo more open abdominal aneurysm repairs than men. We evaluate in-hospital outcomes of EVAR for rAAA by sex. METHODS: The Vascular Quality Initiative (VQI) registry was queried from 2013 to 2019 for rAAA patients treated with EVAR. Univariate analysis was performed with Student's t-test and chi-squared tests. Multivariable logistic regression was then performed to assess the association between female sex and inpatient mortality. RESULTS: A total of 1775 patients were included (23.8% female). Female rAAA patients were older (P< 0.01) and weighed less (P < 0.01). They were less likely to have smoked (P <.0 001) and had lower creatinine (1.29 vs. 1.43, P < 0.01) and hemoglobin (10.7 vs. 11.7, P < 0.01). Women had smaller maximum aortic diameters (74 vs. 66 mm, P < 0.01) and were less likely to have iliac aneurysms (P < 0.001). Women were more likely to have concomitant femoral endarterectomy (8.5% vs. 4.6%, P = 0.03). Despite having no significant difference in complication or reintervention rates, women had higher rates of in-hospital mortality (45.9% vs. 34.5%, P < 0.01). In a logistic regression model for predictors of in-hospital mortality (χ2 < .01), increased age (OR 1.08, P < 0.01), female sex (OR 1.7, P = 0.02), preoperative cardiac arrest (OR 5.29, P < 0.01), concurrent iliac stenting (OR 2.38, P = 0.02), postoperative mesenteric ischemia (OR 2.51, P < 0.01) and postoperative transfusion (OR 1.06, P < 0.01) were independently associated with in-hospital mortality. Increased preoperative hemoglobin was protective (OR 0.89, P < 0.01) CONCLUSIONS: Female sex is independently associated with in-hospital mortality after EVAR for rAAA, suggesting a relationship beyond anatomical, biochemical, and procedural covariates.

Large Fenestrations Versus Scallops for the Superior Mesenteric Artery during Fenestrated Endovascular Aneurysm Repair: Does it Matter?

BACKGROUND: Fenestrated endovascular aneurysm repair is an established customized treatment for aortic aneurysms with 3 current commercially available configurations for the superior mesenteric artery (SMA)-a single-wide scallop, large fenestration, or small fenestration, with the scallop or large fenestration most utilized. Outcomes comparing SMA single-wide scallops to large fenestrations with the Zenith fenestrated (ZFEN) device are scarce. As large fenestrations have the benefit of extending the proximal seal zone compared to scalloped configurations, we sought to determine the differences in seal zone and sac regression outcomes between the 2 SMA configurations. METHODS: We retrospectively reviewed our prospectively maintained complex endovascular aneurysm repair database and included all patients treated with the Cook ZFEN device with an SMA scallop or large fenestration configuration at its most proximal build. All first postoperative computed tomography scans (1-30 days) were analyzed on TeraRecon to determine precise proximal seal zone lengths, and standard follow-up anatomic and clinical metrics were tabulated. RESULTS: A total of 234 consecutive ZFEN patients from 2012 to 2021 were reviewed, and 137 had either a scallop or a large fenestration for the SMA as the proximal-most configuration (72 scallops and 65 large fenestrations) with imaging available for analysis. The mean follow-up was 35 months. The mean proximal seal zone length was 19.5 ± 7.9 mm for scallop versus 41.7 ± 14.4 mm for large fenestration groups (P < 0.001). There was no difference in sac regression between the scallop and large fenestration at 1 year (10.1 ± 10.9 mm vs. 11.0 ± 12.1, P = 0.63). Overall, 30-day mortality (1.3% vs. 2.5%, P = 0.51) and all-cause 3-year mortality (72.5% vs. 81.7%, P = 0.77) were not significantly different. Reinterventions within 30 days were primarily secondary to renal artery branch occlusions, with only 1 patient in the scallop group requiring reintervention for an SMA branch occlusion. CONCLUSIONS: Despite attaining longer proximal seal lengths, large SMA fenestrations were not associated with a difference in sac regression compared to scalloped SMA configurations at a one-year follow-up. There were no significant differences in reinterventions or overall long-term survival between the 2 SMA strategies.

Intraoperative heparin use is associated with reduced mortality without increasing hemorrhagic complications after thoracic endovascular aortic repair for blunt aortic injury.

OBJECTIVE: Thoracic endovascular aortic repair (TEVAR) is an effective treatment of blunt thoracic aortic injury (BTAI). However, the risks and benefits of administering intraoperative heparin in trauma patients are not well-defined, especially with regard to bleeding complications. METHODS: The Vascular Quality Initiative registry was queried from 2013 to 2019 to identify patients who had undergone TEVAR for BTAI with or without the administration of intraoperative heparin. Univariate analyses were performed with the Student t test, Fisher exact test, or χ2 test, as appropriate. Multivariable logistic regression was then performed to assess the association of heparin with inpatient mortality. RESULTS: A total of 655 patients were included, of whom most had presented with grade III (53.3%) or IV (20%) BTAI. Patients receiving heparin were less likely to have an injury severity score (ISS) of ≥15 (70.2% vs 90.5%; P < .0001) or major head or neck injury (39.6% vs 62.9%; P < .0001). Patients receiving heparin also had a lower incidence of inpatient death (5.1% vs 12.9%; P < .01). Across all injury grades, heparin use was not associated with the need for intraoperative transfusion or postoperative transfusion or the development of hematoma. In patients with grade III BTAI, the nonuse of heparin was associated with an increased risk of lower extremity embolization events (7.4% vs 1.8%; P < .05). On multivariable logistic regression analysis for inpatient mortality, intraoperative heparin use (odds ratio [OR], 0.31; 95% confidence interval [CI], 0.11-0.86; P < .05) and female gender (OR, 0.11; 95% CI, 0.11-0.86; P < .05) were associated with better survival, even after controlling for head and neck trauma and injury grade. In contrast, increased age (OR, 1.06; 95% CI, 1.03-1.1; P < .001), postoperative transfusion (OR, 1.06; 95% CI, 1.02-1.11; P < .01), higher ISS (OR, 1.04; 95% CI, 1.01-1.07; P < .05), postoperative dysrhythmia (OR, 4.48; 95% CI, 1.10-18.18; P < .05), and postoperative stroke or transient ischemic attack (OR, 5.54; 95% CI, 1.11-27.67; P < .05) were associated with increased odds of inpatient mortality. CONCLUSIONS: Intraoperative heparin use was associated with reduced inpatient mortality for patients undergoing TEVAR for BTAI, including those with major head or neck trauma and high ISSs. Heparin use did not increase the risk of hemorrhagic complications across all injury grades. Also, in patients with grade III BTAI, heparin use was associated with a reduced risk of lower extremity embolic events. Heparin appears to be safe during TEVAR for BTAI and should be administered when no specific contraindication exists.

Popliteal scoring assessment for vascular extremity injuries in trauma study.

OBJECTIVE: Traumatic popliteal vascular injuries are associated with the highest risk of limb loss of all peripheral vascular injuries. A method to evaluate the predictors of amputation is needed because previous scores could not be validated. In the present study, we aimed to provide a simplified scoring system (POPSAVEIT [popliteal scoring assessment for vascular extremity injuries in trauma]) that could be used preoperatively to risk stratify patients with traumatic popliteal vascular injuries for amputation. METHODS: A review of patients sustaining traumatic popliteal artery injuries was performed. Patients requiring amputation were compared with those with limb salvage at the last follow-up. Of these patients, 80% were randomly assigned to a training group for score generation and 20% to a testing group for validation. Significant predictors of amputation (P < .1) on univariate analysis were included in a multivariable analysis. Those with P < .05 on multivariable analysis were assigned points according to the relative value of their odds ratios (ORs). Receiver operating characteristic curves were generated to determine low- vs high-risk scores. An area under the curve of >0.65 was considered adequate for validation. RESULTS: A total of 355 patients were included, with an overall amputation rate of 16%. On multivariate regression analysis, the risk factors independently associated with amputation in the final model were as follows: systolic blood pressure <90 mm Hg (OR, 3.2; P = .027; 1 point), associated orthopedic injury (OR, 4.9; P = .014; 2 points), and a lack of preoperative pedal Doppler signals (OR, 5.5; P = .002; 2 points [or 1 point for a lack of palpable pedal pulses if Doppler signal data were unavailable]). A score of ≥3 was found to maximize the sensitivity (85%) and specificity (49%) for a high risk of amputation. The receiver operating characteristic curve for the validation group had an area under the curve of 0.750, meeting the threshold for score validation. CONCLUSIONS: The POPSAVEIT score provides a simple and practical method to effectively stratify patients preoperatively into low- and high-risk major amputation categories.

Contemporary outcomes of traumatic popliteal artery injury repair from the popliteal scoring assessment for vascular extremity injury in trauma study.

OBJECTIVE: Traumatic popliteal artery injuries are associated with the greatest risk of limb loss of all peripheral vascular injuries, with amputation rates of 10% to 15%. The purpose of the present study was to examine the outcomes of patients who had undergone operative repair for traumatic popliteal arterial injuries and identify the factors independently associated with limb loss. METHODS: A multi-institutional retrospective review of all patients with traumatic popliteal artery injuries from 2007 to 2018 was performed. All the patients who had undergone operative repair of popliteal arterial injuries were included in the present analysis. The patients who had required a major lower extremity amputation (transtibial or transfemoral) were compared with those with successful limb salvage at the last follow-up. The significant predictors (P < .05) for amputation on univariate analysis were included in a multivariable analysis. RESULTS: A total of 302 patients from 11 institutions were included in the present analysis. The median age was 32 years (interquartile range, 21-40 years), and 79% were men. The median follow-up was 72 days (interquartile range, 20-366 days). The overall major amputation rate was 13%. Primary repair had been performed in 17% of patients, patch repair in 2%, and interposition or bypass in 81%. One patient had undergone endovascular repair with stenting. The overall 1-year primary patency was 89%. Of the patients who had lost primary patency, 46% ultimately required major amputation. Early loss (within 30 days postoperatively) of primary patency was five times more frequent for the patients who had subsequently required amputation. On multivariate regression, the significant perioperative factors independently associated with major amputation included the initial POPSAVEIT (popliteal scoring assessment for vascular extremity injury in trauma) score, loss of primary patency, absence of detectable immediate postoperative pedal Doppler signals, and lack of postoperative antiplatelet therapy. Concomitant popliteal vein injury, popliteal injury location (P1, P2, P3), injury severity score, and tibial vs popliteal distal bypass target were not independently associated with amputation. CONCLUSIONS: Traumatic popliteal artery injuries are associated with a significant rate of major amputation. The preoperative POPSAVEIT score remained independently associated with amputation after including the perioperative factors. The lack of postoperative pedal Doppler signals and loss of primary patency were highly associated with major amputation. The use of postoperative antiplatelet therapy was inversely associated with amputation, perhaps indicating a protective effect.

Open, percutaneous, and hybrid deep venous arterialization technique for no-option foot salvage.

OBJECTIVE: Deep venous arterialization (DVA) is a technique aimed at providing an option for chronic limb-threatening ischemia patients with no options except amputation. In patients with no outflow distal targets permitting bypass, DVA involves creating a connection between a proximal arterial inflow and a distal venous outflow in conjunction with disruption of the vein valves in the foot. This permits blood flow to reach the foot and potentially to resolve rest pain or to assist in healing of a chronic wound. We aimed to provide an up-to-date review of DVA indications; to describe the open, percutaneous, and hybrid technique; to detail outcomes of each of the available techniques; and to relay the postoperative considerations for the DVA approach. METHODS: A literature review of relevant articles containing all permutations of the terms "deep venous arterialization" and "distal venous arterialization" was undertaken with the MEDLINE, Cochrane, and PubMed databases to find cases of open, percutaneous, and hybrid DVA in the peer-reviewed literature. The free text and Medical Subject Headings search terms included were "ischemia," "lower extremity," "venous arterialization," "arteriovenous reversal," and "lower limb salvage." Studies were primarily retrospective case series but did include two studies with matched controls. Recorded primary outcomes were patency, limb salvage, wound healing, amputation, and resolution of rest pain, with secondary outcomes of complication and overall mortality. Studies were excluded if there was insufficient discussion of technical details (graft type, target vein) or lack of reported outcome measure. RESULTS: Studies that met inclusion criteria (12 open, 3 percutaneous, 2 hybrid) were identified, reviewed, and summarized to compare technique, patient selection, and outcomes between open, percutaneous, and hybrid DVA. For open procedures, 1-year primary patency ranged from 44.4% to 87.5%; secondary patency was less reported but ranged from 55.6% at 1 year to 72% at 25-month follow-up. Limb salvage rates ranged from 25% to 100%, wound healing occurred in 28.6% to 100% of cases, and rest pain resolved in 11.9% to 100% across cohorts. For the endovascular approach, primary patency ranged from 28.6% to 40% at 6-month and 10-month follow-up. Limb salvage rates ranged from 60% to 71%, with rates of major amputation ranging from 20% to 28.5%. CONCLUSIONS: This review provides an up-to-date review of DVA indications, description of various DVA techniques, patient selection associated with each approach, and outcomes for each technique.

Early Real-World Experience with EndoAnchors by Indication.

BACKGROUND: The Heli-FX EndoAnchor (EA) system is a transmural aortic fixation device with Federal Drug Administration (FDA) approval for treatment of endoleaks, endograft migration, or high-risk seal zones. Published data are primarily from industry-sponsored registries highlighting safety and efficacy. Our objective is to evaluate real-world outcomes of EA usage after FDA approval across a variety of stent grafts and indications at a single institution. METHODS: We retrospectively reviewed our prospectively maintained aneurysm database for patients undergoing endovascular aortic repair (EVAR) with Heli-FX EAs. Technical success was defined as successful EA deployment, while procedural success was defined as absence of endoleak on completion aortogram. Cohorts were divided by indication and outcomes assessed via review of clinical and radiographic data. RESULTS: From 2016 to 2018, 37 patients underwent EA fixation. We divided the cohort by indication: Group A (prior EVAR with endoleak), B (intraoperative type 1A endoleak), C (high-risk seal zone), and D (thoracic EVAR). In Group A (n = 11), all endoleaks were type 1A and a mean of 10 EAs were deployed with 100% technical and 45.4% procedural success. Two perioperative reinterventions were performed (translumbar coil embolization and proximal graft extension with bilateral renal artery stents). At a mean 10.6 months of follow-up, 45.4% of patients had persistent endoleaks, with 100% aortic-related survival. In Group B (n = 10), a mean of 8.7 EAs were used with 100% technical and procedural success. One immediate adverse event occurred (right iliac dissection from wire manipulation, treated with a covered stent). At 13.6-month mean follow-up, there was significant sac regression (mean 9.75 mm) with no type 1A endoleaks. In Group C (n = 10), a mean of 9.5 EAs were deployed with 100% technical and procedural success. At 11.2-month mean follow-up, there were no residual endoleaks and significant sac regression (mean 3.4 mm). Overall survival was 100%. In Group D (n = 6), a mean of 8.3 EAs were used with 83.3% technical and 66.6% procedural success. One immediate adverse event occurred, in which an EA embolized to the left renal artery. At 9.4-month mean follow-up, overall survival was 83.3% with a mean 2.2-mm increase in sac diameter. CONCLUSIONS: Early experience suggests that EAs effectively treat intraoperative type 1A endoleaks and high-risk seal zones, with significant sac regression and no proximal endoleaks on follow-up. In patients treated for prior EVAR with postoperative type 1A endoleaks, fewer than half resolved after EA attempted repair. Further experience and longer term follow-up will be necessary to determine which patients most benefit from postoperative EA fixation.

Comparison of mid-term graft patency in common femoral versus superficial femoral artery inflow for infra-geniculate bypass in the vascular quality initiative.

OBJECTIVES: The superficial femoral artery can be used as inflow for infra-geniculate bypass, but progressive proximal occlusive disease may affect graft durability. We sought to evaluate the effect of superficial femoral artery versus common femoral artery inflow on infra-geniculate bypass patency within a large contemporary multicenter registry. METHODS: The vascular quality initiative was queried from 2013 to 2019 to identify patients with >30-day patency follow-up, Rutherford chronic limb ischemia stage 1-6, and an infra-geniculate bypass, excluding those with prior ipsilateral bypass. The cohort was stratified by inflow vessel, with primary, primary-assisted, and secondary patency serving as the primary outcome variables. Multivariate Cox-proportional hazard models and radius-based propensity-score matching were performed to reduce treatment-selection bias due to clinical covariates. RESULTS: A total of 11,190 bypass procedures were performed (8378 common femoral artery inflow, 2812 superficial femoral artery) on 10,110 patients, with a mean follow-up of 12.8 months (range 1-98). Patients receiving superficial femoral artery inflow bypasses were more commonly male (p = 0.002), obese (p < 0.0001) and had chronic, limb threatening ischemia (p < 0.0001), whereas those with common femoral artery inflow were older (p < 0.0004), and had higher baseline comorbidities including smoking (p < 0.0001), coronary disease (p < 0.0001), and pulmonary disease (p < 0.0001). On life-table analysis, there was no significant difference in three year estimated primary (32.1 vs 30.1%, p = 0.928), primary assisted (60.5 vs 65.8%, p = 0.191), or secondary patency (62.5 vs 66.7%, p = 0.139) between superficial femoral artery and common femoral artery inflow groups, respectively. A multivariate Cox model found no significant association between inflow vessel and primary patency (0.96 [0.88-1.04], HR [95%CI]), primary-assisted (1.07 [0.95-1.20], HR [95%CI]), or secondary patency (1.08 [0.96-1.22]). In a propensity-matched cohort (n = 11,151), there were small but statistically significant differences in primary, primary-assisted, and secondary patency at latest follow-up (non-time-to-event data) between groups. The largest difference was observed when evaluating secondary patency, with common femoral artery inflow having a marginally higher secondary patency of 88.1% compared to 85.6% for those with superficial femoral artery inflow at latest follow-up (p = 0.009). CONCLUSIONS: Within the vascular quality initiative, there is no significant difference in life-table determined three-year primary, primary-assisted, and secondary patency between infra-geniculate bypasses using common femoral artery inflow compared to superficial femoral artery inflow. Small, statistically significant differences exist in primary, primary-assisted, and secondary patency favoring common femoral artery inflow after propensity score matching. Long-term follow-up data are required in the vascular quality initiative to better evaluate bypass graft durability as this study was limited by a mean follow-up of one year.

Outcomes of Gracilis Muscle Flaps in the Management of Groin Complications after Arterial Bypass with Prosthetic Graft.

BACKGROUND: This study details 2-year outcomes of a modified gracilis muscle flap (GMF) technique in providing tissue coverage for groin complications after arterial bypass surgery with synthetic graft. METHODS: All patients who developed groin infections after lower extremity arterial bypass with synthetic graft who underwent a GMF technique were included from June 2014 to March 2017 from a prospectively collected, purpose-built institutional database. Modifications to the standard technique included identification of the muscle using ultrasound to ensure precise skip incisions, preservation of the segmental blood supply, widening of the tunnel through which the muscle is retroflexed, placement of a wound vacuum-assisted closure for healing, and lifelong antibiotics. Demographics, laboratory values, bypass procedure, length of stay (LOS), disposition, and 1-, 3-, 6-, 12-, and 24-month follow-up data were collected. Analysis was performed via descriptive statistics. RESULTS: Over the 3-year study period, 22 patients underwent GMF after complications resulted from arterial bypass surgery. Types of bypass included aortobifemoral (32%), axillobifemoral (14%), femoral-femoral (23%), femoral-popliteal or mixed distal (27%), and thigh graft for dialysis (4%). Forty-five percentage of patients presented with graft infection, 50% with wound dehiscence, and 5% with graft disruption and bleeding. Only 23% of patients were candidates for sartorius muscle flap at the time of their initial procedure. The average case length was 64 + 19 min. Sixty-four percentage of patients were discharged home with home health care and the remainder to a skilled nursing facility. The average LOS was 6.1 + 3.4 days. Fifty-four percentages of wounds were healed at 1 month and 100% at 3 months with adjunctive vacuum-assisted closure therapy and lifelong antibiotics. Sixty percentage of patients were still alive at 24 months, with 33% of grafts still patent at that time. Median survival was 18.1 months, and median graft patency was 17.9 months. CONCLUSIONS: GMF is a safe and effective treatment for groin complications after arterial bypass surgery with synthetic graft. Owing to its versatility, area of coverage, ease of use, and durability, it potentially should be considered as a primary form of muscle coverage for groin complications.

Artificial intelligence in clinical workflow processes in vascular surgery and beyond.

In the past decade, artificial intelligence (AI)-based applications have exploded in health care. In cardiovascular disease, and vascular surgery specifically, AI tools such as machine learning, natural language processing, and deep neural networks have been applied to automatically detect underdiagnosed diseases, such as peripheral artery disease, abdominal aortic aneurysms, and atherosclerotic cardiovascular disease. In addition to disease detection and risk stratification, AI has been used to identify guideline-concordant statin therapy use and reasons for nonuse, which has important implications for population-based cardiovascular disease health. Although many studies highlight the potential applications of AI, few address true clinical workflow implementation of available AI-based tools. Specific examples, such as determination of optimal statin treatment based on individual patient risk factors and enhancement of intraoperative fluoroscopy and ultrasound imaging, demonstrate the potential promise of AI integration into clinical workflow. Many challenges to AI implementation in health care remain, including data interoperability, model bias and generalizability, prospective evaluation, privacy and security, and regulation. Multidisciplinary and multi-institutional collaboration, as well as adopting a framework for integration, will be critical for the successful implementation of AI tools into clinical practice.

Systematic review and meta-analysis of management of incompetent perforators in patients with chronic venous insufficiency.

OBJECTIVE: Incompetent perforator veins (IPVs) contribute to venous pathology and are surgically treated based on hemodynamic measurements, size, and the CEAP (Clinical, Etiological, Anatomical, and Pathophysiological) classification. The objective of the present study was to systematically review and synthesize the current literature regarding the surgical management of IPVs, including open ligation, subfascial endoscopic perforator surgery (SEPS), endovascular laser ablation, ultrasound-guided sclerotherapy, and radiofrequency ablation. METHODS: English-language literature reported before November 2021 was reviewed from the PubMed, EMBASE, and MEDLINE databases for primary studies reporting safety and efficacy outcomes in the surgical treatment of IPVs. Study quality and risk of bias were assessed using the Cochrane risk of bias tool for comparative studies and a modified version of the Newcastle-Ottawa scale for noncomparative studies. A random effects model was used to pool the effect sizes for efficacy outcomes of wound healing and freedom from wound recurrence. RESULTS: A total of 81 studies were included for qualitative synthesis, representing 7010 patients, with a mean age of 54.7 years. The overall evidence quality was low to intermediate, with a moderate to high risk of bias in the comparative studies. An 11.3% complication rate was found across the interventions, with no reported incidence of stroke or air embolism. Regarding efficacy, the pooled estimates for short-term (≤1 year) wound healing were 99.9% for ultrasound-guided sclerotherapy (95% confidence interval [CI], 0.81%-1%), 72.2% for open ligation (95% CI, 0.04%-0.94%), and 96.0% for SEPS (95% CI, 0.79%-0.99%). For short-term freedom from wound recurrence, the pooled estimate for SEPS was 91.0% (95% CI, 0.3%-0.99%). CONCLUSIONS: The current evidence regarding the treatment of IPVs is limited owing to the low adherence to reporting standards in the observational studies and the lack of randomization, blinding, and allocation concealment in the comparative studies. Additional comparative studies are needed to guide clinical decision-making regarding the invasive treatment options for IPVs.

Interruptive Electronic Alerts for Choosing Wisely Recommendations: A Cluster Randomized Controlled Trial.

OBJECTIVE: To assess the efficacy of interruptive electronic alerts in improving adherence to the American Board of Internal Medicine's Choosing Wisely recommendations to reduce unnecessary laboratory testing. MATERIALS AND METHODS: We administered 5 cluster randomized controlled trials simultaneously, using electronic medical record alerts regarding prostate-specific antigen (PSA) testing, acute sinusitis treatment, vitamin D testing, carotid artery ultrasound screening, and human papillomavirus testing. For each alert, we assigned 5 outpatient clinics to an interruptive alert and 5 were observed as a control. Primary and secondary outcomes were the number of postalert orders per 100 patients at each clinic and number of triggered alerts divided by orders, respectively. Post hoc analysis evaluated whether physicians experiencing interruptive alerts reduced their alert-triggering behaviors. RESULTS: Median postalert orders per 100 patients did not differ significantly between treatment and control groups; absolute median differences ranging from 0.04 to 0.40 for PSA testing. Median alerts per 100 orders did not differ significantly between treatment and control groups; absolute median differences ranged from 0.004 to 0.03. In post hoc analysis, providers receiving alerts regarding PSA testing in men were significantly less likely to trigger additional PSA alerts than those in the control sites (Incidence Rate Ratio 0.12, 95% CI [0.03-0.52]). DISCUSSION: Interruptive point-of-care alerts did not yield detectable changes in the overall rate of undesired orders or the order-to-alert ratio between active and silent sites. Complementary behavioral or educational interventions are likely needed to improve efforts to curb medical overuse. CONCLUSION: Implementation of interruptive alerts at the time of ordering was not associated with improved adherence to 5 Choosing Wisely guidelines. TRIAL REGISTRATION: NCT02709772.

Mid-Term Survival after Thoracic Endovascular Aortic Repair by Indication in the Medicare Population.

BACKGROUND: Thoracic endovascular aortic repair (TEVAR) is indicated for treatment of aneurysms, dissections, and traumatic injury. We describe mid-term mortality and reintervention rates in Medicare beneficiaries undergoing TEVAR. STUDY DESIGN: Patients who underwent TEVAR between 2006 and 2014 were identified by CPT codes in a 20% Medicare sample. Indication for aortic repair (aneurysm, dissection, trauma) was ascertained via ICD-9 codes. Follow-up was evaluated until 2015. Kaplan-Meier survival analysis and Cox regression were used to compare mortality, with reintervention and mortality rates expressed as a composite outcome in a hazard ratio with 95% confidence interval (hazard ratio [HR] 95% CI). RESULTS: There were 3,095 patients who underwent TEVAR during the study period: 1,465 (47%) for aneurysm, 1,448 (47%) for dissection, and 182 (5.9%) for trauma. Mean patient age was 74.4 years, and 44.5% were female. Median follow-up was 2.7 years. The overall 30-day, 1-year, and 5-year, and 8-year survival rates were 93%, 78%, 49%, and 33%, respectively. Thirty-day mortality was highest in traumatic indications, but overall mortality was highest in patients undergoing TEVAR for aneurysm. Freedom from combined reintervention and mortality at 30 days, 1 year, 5 years, and 8 years was 89%, 73%, 43%, and 29%, respectively. Reintervention was highest in patients undergoing TEVAR for dissection (12.8%), followed by aneurysm (10.0%) and trauma (5.5%). Advanced age (HR 1.03 per year, 95% CI 1.02-1.03), congestive heart failure (CHF) (HR 1.48, 95% CI 1.33-1.65), dementia (HR 1.40, 95% CI 1.14-1.28), and rupture (HR 1.38, 95% CI 1.24-1.54) were associated with mortality. CONCLUSIONS: Midterm survival is lower in patients who undergo TEVAR for dissection and aneurysm compared with trauma. Aneurysmal disease, advanced age, CHF, dementia, and aortic rupture are associated with mortality and reintervention in TEVAR.