What is the MAUDE Database Telling us about 510(k) Authorization? Evaluation of Two Generations of Endovascular Arteriovenous Fistula Devices.

BACKGROUND: In 2019, Bard Peripheral Vascular Inc (BV; now Becton, Dickinson and Company; Sparks, Maryland) received Food and Drug Administration (FDA) approval to begin marketing the WavelinQ EndoAVF System through a process known as 510(k) authorization. Such authorization relies on BV proving that the new WavelinQ EndoAVF System was of "substantial equivalence" to the WavelinQ 4F EndoAVF System. We set forth to analyze patient problems and device issues reported for the new device and determine if they were significantly different from the predicate device its 510(k) approval was based on. METHODS: FDA database Manufacturer and User Facility Device Experience was queried for all adverse report events for the WavelinQ EndoAVF System and WavelinQ 4F EndoAVF System. Data were collected on patient issues and device issues. Fisher's exact test was used. RESULTS: There were a total of 125 reports for the WavelinQ 4F EndoAVF System and 78 for the WavelinQ EndoAVF System. There was a significant increase in patient problem "hypertension" (0% vs. 5.1%; P = 0.02) for the WavelinQ EndoAVF System but a statistically significant decrease in device issue "failure to align" for the WavelinQ EndoAVF System (24.8% vs. 10.3%; P ≤ 0.01). CONCLUSIONS: There were changes in device and patient outcomes between the WavelinQ EndoAVF System and WavelinQ 4F EndoAVF System. While we noted a decrease in device problem "failure to align", there was an overall increase in patients' "hypertension" rates. This highlights the importance of the FDA Manufacturer and User Facility Device Experience reporting in ensuring that device safety is maintained when devices are approved for marketing through the 510(k) process.

Carotid artery dissections from transcarotid artery revascularization as reported by the Food and Drug Administration.

OBJECTIVES: Transcarotid artery revascularization (TCAR) is a hybrid procedure that allows reversal of blood flow away from the brain while placing a stent through direct surgical access of the common carotid artery. It has been shown to have a lower risk of perioperative stroke compared with any prospective trial of transfemoral carotid artery stenting. However, intraoperative injuries related to the procedure and its management are not well characterized. One of the intraoperative complications seen in TCAR is iatrogenic carotid artery dissection (CD). We aim to add qualitative insight in further characterizing CDs and its management in this emerging technology. METHODS: The Food and Drug Administration (FDA) maintains the Manufacturer and User Facility Device Experience (MAUDE) database for surveillance of all medical devices approved for use. This database was queried for all cases associated with Silk Road Medical's ENROUTE Transcarotid Neuroprotection System from September 2016 to October 2020. Case narratives related to CD were individually analyzed to determine time of injury (intraoperative, recovery, and post-discharge follow-up). CD reporting was further analyzed for the associated procedural event at the time of injury, number of access attempts to CD repair, and type of CD repair. Reports associated with CD repair were further categorized into endovascular repair and open surgical repair. RESULTS: Of the 115 unique adverse events in the database, there were 58 CDs. Most were identified intraoperatively (n = 55), while three were incidentally found postoperatively. Overall, sheath placement was the most common procedural event attributed to CD (N = 34). There was adequate narrative information about CD repair in 54 patients. Intraoperative repair was performed in 52 cases and two were repaired after post-discharge follow-up imaging was performed.Among CDs that did not require additional access to engage the true lumen, the proportion of endovascular repair (62.5%) was significantly higher (p = .044) compared to the proportion of open surgical repair (37.5%). However, the proportion of open surgical repair (75%) was significantly higher than the proportion of endovascular repair (25%) in CDs with persistent failure to engage the true lumen despite ≥2 access attempts (p = .039). CONCLUSION: CD is the most common injury related to TCAR as reported on MAUDE. The most commonly reported procedural event associated with CD was sheath placement. The rate of intraoperative endovascular and open surgical CD repair was associated with whether the access to the true lumen of the carotid artery required additional access attempts or not. This should add qualitative insight among the vascular surgery community regarding intraoperative management of CDs from a TCAR procedure.

Diagnosis of mental illness does not affect postoperative outcomes in patients undergoing endovascular aortic aneurysm repair in the VA healthcare system.

OBJECTIVE: Mental illness can be a debilitating chronic disease associated with a higher likelihood of preexisting medical comorbidities and postoperative morbidity and mortality. Given the relative prevalence of mental health disorders among the veteran population, we sought to examine postoperative outcomes in patients undergoing endovascular aortic aneurysm repair (EVAR). METHODS: Retrospective review of a single institution Veterans Administration Hospital operative database was used to identify patients who underwent EVAR from January 2010 to December 2021. Patients' demographics, comorbidities, medications, and intraoperative variables were collected. In addition, mental illness status was evaluated to stratify patients based on preexisting anxiety, depression, posttraumatic stress disorder, substance abuse disorder, or major psychiatric illness. The study's primary outcomes were postoperative complications, mortality, and follow-up rates. Secondary outcomes included hospital length of stay, readmission rates, and intervention rates. RESULTS: A total of 241 patients underwent infrarenal EVARs at our institution. One hundred forty patients (58.1%) were diagnosed with mental illness, whereas 101 (41.9%) had no prior diagnosis of mental illness. Of the 241 patients, 65.7% had a history of substance abuse disorder, 38.6% depression, 29.3% post-traumatic stress disorder, 19.3% anxiety, and 3.6% major psychiatric illness. There was no statistical difference in the number of medical comorbidities, race, smoking status, or medications compared with patients without mental illness. We found no statistical difference in access type, wound infection rates, hypogastric coiling, estimated blood loss, and operating time. χ2 analysis demonstrated a statistically significant lower overall postoperative complication rate (28.6% vs 32.7%; P = .05) and decreased loss to follow-up (8.6% vs 15.8%; P = .05) among patients with a preexisting mental illness diagnosis. There were no statistically significant differences in readmission rate, length of stay, or 30-day mortality. When stratified by type of mental illness, binary logistic regression demonstrated no statistically significant differences in primary outcomes of postoperative complications, readmission rates, loss to follow-up, and 1-year mortality. Cox proportional hazards modeling demonstrated no significant difference in cumulative survival in patients diagnosed with a mental illness (0.56; 95% confidence interval, 0.29-0.107; P = .08). CONCLUSIONS: There was no association between the presence of a prior mental health diagnosis and adverse outcomes following EVAR. Preceding mental illness did not correlate with an increased rate of complications, readmission, length of stay, or 30-day mortality in a veteran population. Lower loss to follow-up rates in patients with mental illness may reflect overall Veterans Health Administration expansion in resources and surveillance of these at-risk individuals. Further research is needed to assess the association between postoperative outcomes and mental illness.

A Comparison of Patient and Device Issues Reported for Recalled Venous Stent Systems.

BACKGROUND: The first two Food and Drug Administration (FDA)-approved stents for treatment of iliofemoral vein obstruction, Boston Scientific's Vici and BD's Venovo venous stent systems, were both recalled in early 2021 within years of entering the market. Given the recent addition of patient issues as a publicly reported variable by the FDA Manufacturer and User Facility Device Experience (MAUDE) database, we set forth to analyze adverse event reports in MAUDE to better characterize issues reported for each system. METHODS: MAUDE was queried for all adverse event reports for brands "Vici" and "Venovo" from their respective US FDA market approval dates to August 19, 2021. Reported device issues, patient issues, and interventions performed for each adverse event were compiled and compared using Fisher's exact test. RESULTS: A total of 50 unique adverse event reports were compiled for the Vici system and 341 for the Venovo system. The most common device issue reported for the Vici system was migration (48% vs. 0%; P = 0.0001) versus activation failure in Venovo (85% vs. 4%; P = 0.0001). A significantly higher proportion of Venovo reports specified no patient complications or symptoms (90% vs. 26%; P = 0.0001), with no intervention performed (89% vs. 32%; P = 0.001). A significantly higher proportion of Vici devices were extracted (8% vs. 2%; P = 0.01), required use of a new device (26% vs. 5%; P = 0.0001), and required application of a second stent within the venous stent initially placed (28% vs. 2%; P = 0.0001). The rate of intervention with balloon expansion was not significantly different between the Vici and Venovo systems (6% vs. 2%; P = 0.08). CONCLUSIONS: While 2 venous stent systems were recalled simultaneously, significant differences exist between reported device issues in MAUDE and whether patient injury was involved and well described. Our data suggest that despite recent improvements to MAUDE reporting, additional standardization with specificity regarding patient issues and interventions is needed to assist vascular surgeons monitoring real-time adverse event trends for vascular devices.

Medical optimization of the peripheral artery disease patient.

Peripheral artery disease (PAD) impacts an estimated 230 million adults worldwide, including more than 9.5 million adults older than 40 years in the United States. PAD remains more underdiagnosed and undertreated than manifestations of atherosclerosis elsewhere in the body, such as coronary artery disease and cerebrovascular disease. Medical therapies benefit all patients with PAD, including those who are asymptomatic, as well as those with symptoms and advanced disease requiring intervention. Comprehensive medical management of PAD is based on tempering atherosclerotic disease processes and should include smoking cessation, exercise therapy, cholesterol reduction, antiplatelet, and/or anticoagulation therapy, as well as the application of peripheral vasodilators and blood pressure control, when indicated. For patients with intermittent claudication, supervised exercise therapy has been shown to provide similar or superior benefit compared with intervention and is recommended by major society guidelines as first-line therapy. In patients with advanced PAD requiring endovascular or surgical intervention, continued adherence to optimal medical therapy has been found to improve functional outcomes and decrease post-interventional mortality. Optimal medical management provides crucial benefits to patients with early, moderate, and advanced PAD and, once started, should be continued for life.

Central Line Access for Hemodialysis Adversely Affects Ipsilateral Arteriovenous Graft Outcomes.

BACKGROUND: Central venous stenosis is a common problem that diminishes vascular access lifespan. Current national guidelines recommend that central catheters and arteriovenous grafts (AVGs) be placed contralateral to an existing hemodialysis access. We set forth to delineate any clinically significant outcomes based on laterality in patients undergoing AVG placement with an existing central catheter for dialysis treatments. METHODS: Using a Veterans Administration Hospital dialysis access database over a four-year period (May 2014 to April 2018), we identified all patients who underwent AVG placement in an upper extremity with an existing ipsilateral (Ipsi-CL) or contralateral (Contra-CL) central line for hemodialysis. AVG outcomes examined included successful cannulation, functional patency, thrombosis events, and endovascular interventions per access site. Clinical records were also examined for location of AVG, arteriovenous fistula or AVG precursors, prior central line placement, peripherally inserted central catheter, and cardiac venous access. All outcomes were followed until July 2021. Student's t-test, Fisher's exact test, and multivariable analysis were used. RESULTS: A total of 71 AVGs: 55 (77%) were placed contralateral to existing central venous catheters and 16 (23%) were placed on the ipsilateral side. Baseline characteristics between the two groups were not found to be significantly different. This included a history of hypertension, smoking history, prior arteriovenous access, body mass index, race, glucose, creatinine, blood urea nitrogen, hemoglobin, mean corpuscular volume, platelet count, antiplatelet agent, and anticoagulation. 100% (n = 16) of patients in the Ipsi-CL group had previous central venous access compared to 49.1% (n = 27) in Contra-CL (P = <0.001). The mean functional patency for AVG with Contra-CL was 724.78 ± 593.98 days compared to AVGs with Ipsi-CL with mean days of 350.94 ± 431.23 days (P = 0.001). A history of previous central venous catheterization and graft on ipsilateral side of a catheter at the time of surgery was associated with decreased functional duration of graft (odds ratio, 0.25; P = 0.03). CONCLUSIONS: Within this cohort of patients that underwent AVG, we noted a statistically significant decrease in the duration of functional patency of grafts ipsilateral to central venous catheters. We did not find a difference in cannulation rates, thrombosis events, or overall endovascular interventions. Ipsilateral central access appears to be associated with decreased functional patency of AVGs. These findings highlight a discrepancy that is potentially clinically relevant and further studies are warranted.

Assessing Resident Impact on Surgical Outcomes in Below-the-Knee Amputations Based on Operative Autonomy.

BACKGROUND: Gradual increases in resident autonomy with attending physician oversight is crucial to developing safe and competent surgeons1. The Veterans Affairs Surgical Quality Improvement Program (VASQIP) follows surgical outcomes within the VA. We set forth to examine the VASQIP database to compare outcomes between resident independent cases and nonindependent cases during below-the-knee amputations (BKA). METHODS: All VASQIP records for BKA from 2000 to 2020 were examined and categorized based on whether the attending was scrubbed during the case. Case matching was performed based on preoperative comorbidities; 30-day postoperative outcomes, including a return to the operating room, wound infection, and mortality, were assessed in addition to operative time, hospital length of stay, and transfusion requirements. Student's t-test and Fisher's Exact Test were utilized. RESULTS: A total of 13,208 BKA VASQIP records were obtained. After case control matching, 2,688 cases remained. Cases were identified with the attending surgeon noted as being scrubbed during the case (n = 1,344), or not scrubbed (n = 1,344). Patients were similar in comorbidities across both groups. No statistically significant difference in operative time (1.52 hr ± 0.78 vs. 1.47 hr ± 0.75, P = 0.08), 30-day mortality (3.3% vs. 4.8%, P = 0.05), or complication rate (19.5% vs. 21.3%, P = 0.25). Resident independent cases were noted to have slightly longer postop length of stay (12.47 days ± 12.69 vs. 15.33 days ± 20.56, P < 0.01) and operative bleeding requiring more than 4 units transfused (0.3% vs. 1.3%, P ≤ 0.01). CONCLUSIONS: Resident independent operating during below-the-knee amputation at VA hospitals is associated with an increased length of stay and blood transfusion. There was no statistically significant increase in operative time, 30-day mortality, or total complication rate. Further research is required to assess the risks associated with surgical training, resident supervision, and resident preparedness for independent practice.

Elevated Risk Analysis Index (RAI) Frailty Scores Are Independently Associated with Adverse Outcomes in Lower Extremity Surgical Revascularizations Similarly Across Genders.

BACKGROUND: The Risk Analysis Index (RAI) frailty scoring system has recently undergone revision and external validation using the National Surgical Quality Improvement Program (NSQIP) database. We set forth to evaluate the association of RAI-rev ranges with outcomes following lower extremity surgical revascularization and verify equivalent applicability across genders. METHODS: All elective NSQIP Targeted Lower Extremity Open cases from 2015-2019 were divided by EMR-recorded gender. Aggregate demographics, perioperative factors, and 30-day outcomes were compared using unpaired t-test and Fisher's exact test. Adjusted odds-ratios (aOR) for each outcome were generated by applying a multivariate binary logistic regression model (IBM SPSSTM) for five-point RAI-rev score increments from 25-45 and a most-frail group with scores >45 with a non-frail reference of <25. Covariates included surgical indication, prior ipsilateral revascularization, graft utilization, dirty/infected wound, smoking, hypertension, diabetes, and steroid use. RESULTS: 8,155 cases included 2,498 (31%) performed in women who demonstrated slightly lower RAI-rev scores than men (22.1 ± 5.8 vs. 24.2 ± 5.1; P = 0.0001). Univariate trends demonstrated dose-dependent increases in frequency of most outcomes with rising frailty score ranges, most substantially regarding mortality (0.4% non-frail to 14.7% most-frail), disposition to skilled nursing facility (8% non-frail to 27% most-frail), and extended length of stay (16% non-frail to 44% most-frail). After adjusting for co-variates, patients with RAI-rev scores of 26-30 had aOR of 1.4 (95% CI: 1.2-1.6; P < 0.001), 1.9 (95% CI: 1.6-2.2; P < 0.001), and 2.4 (95% CI:1.3-4.4; P < 0.001) for extended stay, disposition to skilled nursing, and mortality respectively. Trends were similar across genders in both univariate and multivariate analyses. CONCLUSIONS: Mortality, extended stay, and increased rehabilitation needs after surgical revascularization were associated with higher RAI-rev score ranges in a dose dependent manner similarly across genders.

Modern Lower Extremity Bypass Outcomes by Anesthesia Type in the Veteran Population.

BACKGROUND: Lower extremity bypass (LEB) revascularization can be performed under general (GA) or neuraxial anesthesia (NA). Studies show that the use of NA may decrease morbidity, 30-day mortality, and hospital length-of-stay (LOS). The goal of our analysis is to examine the differences in postsurgical outcomes following LEB between patients who undergo GA compared to NA in the Veteran Affairs Surgical Quality Improvement Program (VASQIP) database. METHODS: After IRB approval, the VASQIP database was assessed for patients who underwent LEB between 1998-2018. Only infrainguinal bypass procedures and anesthesia type classified as "general," "epidural," or "spinal" were included. The neuraxial cohort includes both spinal and epidural anesthesia patients. The Risk Analysis Index (RAI), a validated measure of frailty, was additionally calculated for each patient. Chi squared, paired t-test, and binary logistic regression were used to compare the cohorts. RESULTS: During this period, 22,960 veterans underwent LEB recorded in VASQIP. Compared to those who underwent surgery under GA, patients with procedures performed using NA were older (66.4 ± 9.6 years vs. 65.3 ± 9 years respectively; P <0.001) and more frail (average RAI score 25.7 ± 7.0 vs. 24.9 ± 6.7; P < 0.001). Operative time was shorter in the NA group (4.1 ± 1.7 hrs vs. 4.7 ± 3.0 hrs; P < 0.001) and fewer cases were emergent (1.55% vs. 4.13%; P <0.001). Patients in the GA group had higher rates of postoperative prolonged ileus (0.31% vs. 0.00%; P = 0.03), pneumonia (1.60% vs. 1.06%; P = 0.025), deep wound infection (2.67% vs. 2.61%; P = 0.01), sepsis (1.68% vs. 0.79%; P < 0.001), reintubation (1.80% vs. 1.30%) (P = 0.04),and number of packed red blood cell (pRBC) transfused intraoperatively (0.39 ± 1.21 units vs. 0.22 ± 0.79 units; P <0.001). There was no significant difference in rate of graft failure, return to the OR, myocardial infarction, death, or LOS. In regression analysis, those undergoing NA were less likely to require pRBC transfusion intraoperatively (OR: 0.43; 95% CI: 0.31-0.61; P < 0.001), however no other outcomes reached statistical significance. CONCLUSION: Although younger and less frail, veteran patients undergoing GA for lower extremity revascularization had higher rates of postoperative ileus, pneumonia, deep wound infection, sepsis, and need for transfusion as compared to those undergoing NA. There was no significant difference in the rate of other major complications, myocardial infarction, death or LOS. After adjustment, only intraoperative transfusion remained statistically significant, likely reflecting longer and more complex cases for those that undergo general anesthesia rather than the effect of anesthetic choice itself.

Gender trends of authors presenting at a regional vascular surgery meeting.

OBJECTIVE: We hypothesized a potential gender disparity within a regional society like the Southern Association of Vascular Surgery (SAVS) when compared with vascular surgery demographics in the region. To assess this, we analyzed meeting and membership participation at the SAVS compared with regional data from the Society of Vascular Surgery as well as board certification in vascular surgery published by the American Board of Surgery (ABS). METHODS: The published programs from the SAVS Annual Meeting from 2012 to 2019 were analyzed for membership, presenter gender, type, topic, discussant gender, moderator gender, postgraduate course presenter gender, and manuscript publication demographics. The ABS was petitioned and yearly Vascular Surgery diplomate (ABS-VS) gender from member states of the SAVS was examined for the same period. Fisher's exact Student's t-test and analysis of covariance were used. RESULTS: There were 257 total presentations (184 podium, 71.6%; 73 poster, 28.4%). A total of 61.4% (n = 43) of presentations by females were podium presentations, compared with 75.4% (n = 141) by males (P = .03). Females were less likely to be published when compared with their male counterparts (41.8% vs 58.7%, P = .02). The percentage of female gendered presenters statistically increased over the time period examined compared with a decrease in male presenters (R2 = 0.61, m = 1.27 vs R2 = 0.08, m = -0.35, P = .02). Female presenters had a female discussant 10.5% of the time compared with male presenters who had a male discussant 95.1% of the time (P < .0001). Females comprised 3.8% ± 1.1% of SAVS yearly membership compared with 12.0% ± 4.6% ABS-VS diplomates among SAVS member states (P < .0001). SAVS female membership significantly lagged behind the increase in ABS-VS female diplomate rate (P = .001). Only 39.1% of SAVS members were cross-listed in Society of Vascular Surgery membership rolls, with a total of 464 potential SAVS members, 11.2% or 52 of whom are female. CONCLUSIONS: We found that female presenters at the SAVS Annual Meeting were less likely to be podium presenters, interface with other female discussants, and publish manuscripts when compared with their male counterparts. Statistically, female members were underrepresented within the SAVS membership rolls when compared with known boarded female vascular surgeons among southern member states. This gender gap highlights a unique opportunity to enhance and potentially increase mentorship opportunities for female trainees who are presenting and/or attending this regional vascular surgery meeting.

Using the risk analysis index to assess frailty in a veteran cohort undergoing endovascular aortic aneurysm repair.

OBJECTIVE: Surgical frailty is strongly associated with increased perioperative morbidity and mortality. The risk analysis index (RAI) is a validated frailty score system, which has been shown to predict for short-term outcomes and long-term mortality in various surgical subspecialties. In the present study, we applied the frailty score to a veteran aneurysm population who had undergone nonemergent endovascular aortic aneurysm repair (EVAR). METHODS: After obtaining institutional review board approval, the Veteran Affairs Surgical Quality Improvement Program data were queried for endovascular repair of infrarenal abdominal aortic aneurysm or dissection using the Current Procedural Terminology codes 34,800, 34,803, and 34,805 from 2001 to 2018. The preoperative variables were used to calculate the RAI score. The patients were placed into six cohorts according to the RAI score (≤20, 21-25, 26-30, 31-35, 35-40, and ≥41). The χ2 test and analysis of variance test were used compare the cohorts. Forward logistic regression modeling was used to determine the risks of each cohort. RESULTS: From 2001 to 2018, 5568 patients had undergone EVAR. Of the 5568 patients, 99.6% were male, with a mean age of 71 ± 8 years. Of these patients, 4.5%, 43.8%, 33.9%, 11.7%, 4.2%, and 1.8% were included in the following RAI groups: ≤20, 21 to 25, 26 to 30, 31 to 35, 35 to 40, and ≥41, respectively. Frailty was associated with increased rates of overall complications, death, and an increased length of stay. When risk adjusted, frailty at the highest vs lowest level was associated with 2.7 times the odds of any complication developing and 4.4 times the odds of mortality ≤30 days. CONCLUSIONS: Frailty, as determined by the RAI, was associated with postoperative outcomes in a dose-dependent manner. Frailty was associated with higher rates of major cardiac (myocardial infarction, cardiac arrest), pulmonary (pneumonia, failure to wean from ventilation, reintubation), renal (renal failure), overall complications, length of stay, and death. We recommend the use of this frailty index as a screening tool to guide discussions with patients scheduled to undergo EVAR.

Frailty Measurement and Implications for Cerebrovascular Disease Management in a Veteran Based Population.

BACKGROUND: Rapid and objective preoperative assessment of patients undergoing carotid endarterectomy (CEA) remains difficult and variable. The Risk Analysis Index (RAI) is a validated medical record-based assessment of frailty that has been used to predict clinical outcomes for patients undergoing surgical procedures including CEA. We applied RAI to a veteran population following CEA for asymptomatic cerebrovascular disease and examined the factors related to post-operative morbidity and mortality. METHODS: After obtaining IRB approval, Veteran Affairs Surgical Quality Improvement Program data was queried for CEA procedures from 2002 to 2015 for ICD-9 codes indicating asymptomatic patients. RAI was then calculated based on Veteran Affairs Surgical Quality Improvement Program variable medical record extraction. Three groupings of patients were undertaken including non-frail (RAI < 30), frail (RAI 30-34) and very frail (RAI ≥ 35). Chi squared and ANOVA were used to assess cohort differences. Binary logistic regression was used to evaluate predictors of post-operative stroke, myocardial infarction (MI), any complication, and death. RESULTS: Between 2002 and 2015, 37,873 asymptomatic patients underwent CEA. Over 98% (37,266) of the patients were male with an average age of 68.3 ± 8.55 years. The cohorts contained 82.8% (n = 31,362), 12.4% (n = 4,678), and 4.8% (n = 1,833) for the non-frail, frail and very frail groups respectively. Frailty was associated with increased rates of post-operative stroke, MI, any complication, death, and longer hospital length of stay (P< 0.001). Operative time did not significantly differ between the groups. Increasing frailty was associated with having one or more complications (OR 1.69, 95% CI 1.50-1.90 for frail and OR 2.79, 95% CI 2.41-3.24 for very frail, (P< 0.001), post-operative stroke in frail (OR 1.33 95% CI 1.06-1.67) and very frail (OR 1.57 1 95% CI 1.14-2.16) patients, and MI in both frail (OR 1.68, CI 1.17-2.43) and very frail (OR 3.73, CI 2.52-5.51) patients. Frailty was also significantly associated with death with in very frail patients (OR 4.14, 95% CI 3.00-5.71, P< 0.001). CONCLUSION: Increasing frailty as determined by RAI was associated with worse post-operative outcomes in asymptomatic patients undergoing CEA. Higher RAI score cohorts were associated with higher rates of postoperative stroke, MI, complications, and death. We recommend the use of this frailty index as a screening tool to guide risk discussions with asymptomatic patients undergoing CEA.

Analysis of Twitter Activity and Engagement From Annual Meetings of the Society for Vascular Surgery and the Society of Interventional Radiology.

BACKGROUND: Medical societies such as the Society for Vascular Surgery (SVS) and the Society of Interventional Radiology (SIR) have been encouraging the use of social media at annual meetings by establishing unique meeting hashtags (eg. #VAM19, #SIR19ATX). These two specialties have similar number of active physicians and share procedural interests. We set forth to understand differences in Twitter activity and engagement by analyzing Twitter outputs from the vascular annual meeting (VAM) and the interventional radiology annual meeting (IRAM) in 2019. METHODS: Tweets with "#VAM19" and "#SIR19ATX" from 30 days before and 30 days after respective meetings were collected. Proportion of distinct Twitter users relative to total number of meeting attendees, number of posts per user, number of hashtags per post, and number of engagement metrics (likes, replies, and retweets) were collected for comparison. As for the top 100 most liked tweets, specialty-related hashtags were categorized into identity, diversity, education, procedure, and medical care, and the authors of these tweets were also identified for comparison. Student's t-test* and Fisher's Exact⁎⁎ were utilized for analysis. RESULTS: A total of 362 and 1944 tweets were collected from the VAM and IRAM in 2019. There was no difference in proportion of active Twitter users relative to total number of meeting attendees between the VAM (7.5%) and IRAM (7.7%). Average number of posts per user from the VAM and IRAM showed no significant difference. However, tweets related to IRAM had significantly higher number of hashtags per post (2.67±1.96) than ones related to VAM (1.78±1.26) (P < 0.0001*). Additionally, these tweets on average received significantly higher number of likes (P < 0.0001*), retweets (P < 0.0001*), and replies (P < 0.0001*) than ones related to the VAM. Specialty-related hashtags from the 100 most liked tweets showed significantly greater proportion of hashtags associated with specialty identity (4% vs 28.6%, P < 0.0001**), diversity (2.9% vs 8.0%, p=0.0268**), and education (1.1% vs 9.1%, p=0.0004**) in tweets related to the IRAM whereas the proportion of hashtags associated with procedure and medical care was similar between the two meetings. Lastly, the 100 most liked tweets were authored by trainees (p=0.005*) and official societies (p=0.003*) in significantly greater proportion in IRAM whereas academic institutions/training hospitals authored in significantly greater proportion (p=0.004*) from the VAM. Contributions from attending physician users to the 100 most liked tweets were similar between the two meetings. CONCLUSION: Analysis of Twitter activity centered around #VAM19 and #SIR19ATX indicates that there was no significant difference in proportion of Twitter users relative to meeting attendees and average number of posts per user. However, tweets with #SIR19ATX had significantly higher number of hashtags per post and had greater level of engagement than ones with #VAM19. The top 100 most liked tweets from the two meetings differed in proportion of hashtags related to specialty identity, diversity, and education, as well as proportion of contributing authors identified as trainees, official societies, and academic institutions/training hospitals. These data should help the SVS and its members to establish a more directed social media effort to facilitate its use during national gatherings.

Frailty Index associated with postoperative complications and mortality after lower extremity amputation in a national veteran cohort.

OBJECTIVE: Surgical frailty and its assessment have become essential considerations in perioperative management for the modern aging surgical population. The risk analysis index is a validated frailty score that has been proven to predict short-term outcomes and long-term mortality in several surgical subspecialties and high-risk procedures. We examined the association of risk analysis index scores with postoperative outcomes in a retrospective nationwide database of patients who underwent lower extremity amputation in the Veterans Health Administration Health Care System. METHODS: The Veteran Affairs Surgical Quality Improvement Program data was queried across the Veteran Affairs Health Care System with institutional review board approval for lower extremity amputations. Records of above and below knee amputation, Current Procedural Terminology codes 27590, 27591, 27592, 27594, 27596 and 27880, 27881, 27882, 27884, and 27886, respectively, from 1999 to 2018 were obtained. Incomplete and traumatic entries were removed. Risk Analysis Index score was calculated from preoperative variables and patients were separated into five score cohorts (≤15, 16-25, 26-35, 36-45, ≥46). The χ2 test and analysis of variance were used to compare the cohorts. Forward binary logistic regression modeling was used to determine covariate-adjusted odds ratios for outcomes in each cohort (SPSS software; version 25, IBM Corp). RESULTS: A total of 47,197 patients (98.9% male) with an average age of 66.4 ± 10.6 years underwent nontraumatic lower extremity amputation, including 27,098 below knee and 20,099 above knee amputations, during the study period. Frailty was associated with increased rates of deep vein thrombosis, sepsis, cardiac arrest, myocardial infarction, pneumonia, intubation for more than 48 hours, pulmonary embolism, reintubation, acute kidney injury, renal failure, increased length of stay, overall complications, and death. Increases in the frailty score were associated with up to three times the likelihood for the occurrence of a postoperative complication and up to 32 times likelihood to perish within 30 days than those with low frailty scores. CONCLUSIONS: Risk analysis index assessment of frailty was found to be associated with several postoperative outcomes in a dose-dependent manner in patients undergoing lower extremity amputation in the Veterans Health Care System, with higher scores associated with higher rates of death and major cardiac (myocardial infarction, cardiac arrest), pulmonary (pneumonia, failure to wean vent, reintubation), and renal (renal insufficiency, renal failure) complications. We recommend the use of risk analysis index score as a frailty screening tool for patients undergoing lower extremity amputation to enable providers to adequately inform and counsel patients regarding potential significant risks.

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.

Multivessel tibial revascularization does not improve outcomes in patients with critical limb ischemia.

OBJECTIVE: Multivessel tibial revascularization for critical limb ischemia (CLI) remains controversial. The purpose of this study was to evaluate single vs multiple tibial vessel interventions in patients with multivessel tibial disease. We hypothesized that there would be no difference in amputation-free survival between the groups. METHODS: Using the Vascular Quality Initiative registry, we reviewed patients undergoing lower extremity endovascular interventions involving the tibial arteries. Patients with CLI were included only if at least two tibial vessels were diseased and adequate perioperative data and clinical follow-up were available for review. The primary outcome was amputation-free survival. RESULTS: There were 10,849 CLI patients with multivessel tibial disease evaluated from 2002 to 2017; 761 limbs had adequate data and follow-up available for review. Mean follow-up was 337 ± 62 days. Of these, 473 (62.1%) underwent successful single-vessel tibial intervention (group SV), whereas 288 (37.9%) underwent successful multivessel (two or more) intervention (group MV). Patients in group MV were younger (69.1 vs 73.2 years; P < .001), with higher tobacco use (29.5% vs 18.2%; P < .001). Group SV more commonly had concurrent femoral or popliteal inflow interventions (83.7% vs 78.1%; P = .05). Multivessel runoff on completion was significantly greater for group MV (99.9% vs 39.9%; P < .001). No differences were observed between group SV and group MV for major amputation (9.0% and 7.6%; P = .6), with similar amputation-free survival at 1 year (90.6% vs 92.9%; P = .372). In a multivariate Cox model, loss of patency was the only significant predictor of major amputation (hazard ratio, 5.36 [2.7-10.6]; P = .01). A subgroup analysis of 355 (46.6%) patients with tissue loss data showed that tissue loss before intervention was not predictive of future major amputation. CONCLUSIONS: In the Vascular Quality Initiative registry, patients with CLI and occlusive disease involving multiple tibial vessels did not appear to have a limb salvage benefit from multiple tibial revascularization compared with single tibial revascularization.

Early Experience with the Octopus Endovascular Strategy in the Management of Thoracoabdominal Aneurysms.

BACKGROUND: The Octopus endovascular strategy involves placement of multiple, stacked bifurcated grafts in the thoracic segment of a thoracoabdominal aneurysm (TAAA) to facilitate deployment of multiple parallel covered stents for visceral perfusion. This study aimed to review early outcomes of the Octopus TAAA repair strategy at a tertiary, high-volume referral center. METHODS: All patients who underwent this Octopus procedure from 2015 to 2018 were reviewed from a prospectively collected single-institution registry. Demographics, comorbidities, and aneurysm anatomy including side and extent, perioperative data including blood loss, length of procedure length of stay, morbidity, and mortality up to 3 years after the procedure were elevated. RESULTS: A total of 21 patients (48% female, age 72.9 years) underwent the Octopus procedure over the study period. Mean TAAA diameter was 6.7 cm, with 14% dissection related and 86% degenerative TAAA. All patients had been turned down for open repair and 3 (14%) were performed urgently of which 2 were ruptures. TAAA extent was 9% type 2, 62% type 3, and 29% type 4. A mean of 3.04 branches were revascularized per patient, with the superior mesenteric artery (SMA) (90%) perfused through its own limb, and both renals usually reconstructed in parallel graft fashion (left 90%, right 85.7%) with the distal abdominal extension through one of the limbs. Mean operative time was 8 hr, fluoroscopy time 164 min, contrast 182 mL, and blood loss 807 mL. We staged the thoracic and juxtavisceral portions of the cases in 24% of patients. 90% of cases were able to be completed with exclusion of the TAAA and all planned visceral branches cannulated. Perioperative complications included paraplegia (19%) (13.3% permanent, 26.6% temporary), acute kidney injury (24%), prolonged ventilation (19%), myocardial infarction (4.9%), and ischemic bowel (4.8%). Median follow-up was 13.5 months (range 1-26 months). At latest follow-up, type I endoleak rate was 9.5%, with all being treated with proximal cuffs. Other second interventions included restenting of a right renal, angioplasty of an iliac limb kink, and type 2 endoleak coiling. Primary patency of visceral branches was 93.8% at latest follow-up (celiac 100%, SMA 94.7%, right renal 88.9%, left renal 94.8%). In-hospital all-cause mortality rate was 14.2%, with 30-day survival being 90.5%, 6-month survival was 88.3%, one-year survival 71.4%, and 3-year survival was 52.1%. CONCLUSIONS: The Octopus procedure is a high-risk option for urgent or emergent endovascular TAAA repair with off-the-shelf devices in patients who are not candidates for open repair.

Surgical management of functional popliteal entrapment syndrome in athletes.

BACKGROUND: Functional popliteal artery entrapment syndrome (FPAES) is a rare disorder described in young, physically active adults that can be limb or performance threatening if untreated. We used provocative computed tomography angiography (CTA) in these patients to guide partial debulking of the anterolateral quadrant of the medial head of the gastrocnemius muscle for FPAES and reviewed the outcomes of this technique in this highly specialized cohort. METHODS: Athletes referred with symptoms of FPAES underwent a CTA protocol with provocative plantarflexion and dorsiflexion to confirm compression and were offered surgery. All patients underwent posterior approach operative exposure of the popliteal artery, adhesiolysis, side branch ligation, and partial excision of the gastrocnemius muscle with or without fasciotomies. Preoperative imaging, operative findings, and midterm follow-up, including return to baseline function and return to competitive function, as well as symptom recurrence, were retrospectively reviewed. RESULTS: Thirty-six athletes had a total of 56 limbs treated. The average patient age was 26.9 years and the majority were female (56%). Thirty-one percent of patients were referred after already having undergone prior fasciotomies. Sports involved included track and field or running (47%), soccer (25%), water sports (8%), basketball (6%), lacrosse (6%), climbing (3%), skiing (3%), and gymnastics (3%). Of the patients, 27 (75%) had bilateral symptoms and evidence of entrapment; however, only 20 of the 36 (56%) underwent bilateral surgical treatment for symptom resolution. The mean amount of gastrocnemius muscle removed was 7.6 cm3. Nine percent of limbs underwent a bypass along with debulking owing to arterial occlusion at presentation. Postoperatively, there were no nerve or vascular complications noted, although two patients had wound/seroma complications (6%). At the first follow-up, all patients reported mild symptom improvement, but at the midterm follow-up (mean follow-up time, 16 months), six (17%) reported mild to moderate recurrence of symptoms. Of the patients, 78% were able to fully return to their previous competitive levels of sports. All patients were able to resume their athletic endeavor at a recreational level. CONCLUSIONS: More than three-fourths of athletes limited by FPAES demonstrate full return to prior competitive levels with fasciotomy and surgical debulking of the anterolateral quadrant of the medial gastrocnemius muscle. Provocative CTA protocols can help to guide the location of muscle debulking to alleviate the functional entrapment that occurs in these athletes with exercise. This technique is a viable option in athletes with FPAES looking to return to competitive athletics.

Long-term durability of Oakes salvage procedure to preserve Brescia-Cimino arteriovenous fistula.

BACKGROUND: In 2002, Oakes et al described a novel procedure designed to salvage the distal cephalic venous outflow of a Brescia-Cimino fistula by placing a prosthetic graft between the brachial artery in the antecubital space and the cephalic vein at the wrist. In this fashion, the more proximal veins were saved for future procedures. Their approach was reported and found to be successful in the short term, but the long-term durability of the Oakes procedure has not been described. This study aimed to determine the long-term primary, primary-assisted, and secondary patency rates of the brachial to distal cephalic vein Oakes procedure. METHODS: This is a retrospective review of a prospective database in a large, single institution. All patients who underwent the Oakes procedure from 1998 to 2012 were followed up to 2018. We reviewed the time to intervention, type of intervention, patency rates, and mortality of this patient population. RESULTS: Over the 5-year study period, 14 patients were identified who underwent the Oakes procedure, of whom seven (50%) were female. The average age was 55.7 years (range, 38-73 years). All patients had a previously placed Brescia-Cimino that was not suitable for dialysis but was patent. The average number of days to placement of an Oakes brachial to distal cephalic graft was 396 (range, 119-1167) days. A total of 71% (10) of patients underwent an intervention to maintain the graft, of whom 50% (5) underwent an angioplasty and 50% (5) had a thrombectomy/revision procedure. The average number of days to first intervention was 367.3 (range, 21-1048) days from Oakes placement. Of this cohort, 30% (3) of patients had a second intervention, of whom one (33%) underwent an angioplasty and two (66%) had revisions. One patient had a third and a fourth intervention at 39 days and 74 days, respectively, that were both angioplasties. The overall number of days the Oakes procedure remained usable from placement was 843.6 (range, 21-3790) days or 2.3 years. CONCLUSIONS: This study concluded that the Oakes procedure may extend the use of the distal dialysis access site by 2.3 years without increasing infection and is hence a durable solution that should be considered in patients requiring dialysis access.