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.

Just the gastrointestinal stromal tumor: A case report of medical modeling of a rectal gastrointestinal stromal tumor.

A 54-year-old African-American male presented to the colorectal surgery clinic with the chief complaint of a painful anal swelling that had been ongoing for several weeks. An adequate rectal examination was not possible due to severe pain. Therefore, he was taken to the operating room for an exam under anesthesia where a presacral mass was identified. A transgluteal core needle biopsy was performed which was consistent with gastrointestinal stromal tumor. Computed tomography imaging identified a 16 cm ×10 cm ×9 cmrectal gastrointestinal stromal tumor. Given the size and location, the patient began treatment with neoadjuvant Imatinib. His progress was followed with serial computed tomography scans and clinic visits. A 3D model was created the tumor and surrounding structures to aide in pre- and intraoperative planning. The model was utilized during patient education and found to valuable in describing the potential for levator invasion and framing potential post-operative outcomes. The patient was able to undergo rectal preservation via a robotic low anterior resection with a transanal total mesorectal excision, coloanal anastomosis, and diverting ileostomy.

Representation of Women and Racially and Ethnically Marginalized Principal Investigators in Vascular Device Trials.

This quality improvement study describes the lack of diversity in trial leadership, especially in arterial disease device trials, and recommends action steps.

Comparing Outcomes in Patients Undergoing Colectomy at Veteran Affairs Hospitals and Non-Veteran Affairs Hospitals: A Multiinstitutional Study.

INTRODUCTION: The Veteran Affairs Surgical Quality Improvement Program (VASQIP) and National Surgical Quality Improvement Program (NSQIP) are large databases designed to measure surgical outcomes for their respective populations. We sought to compare surgical outcomes in patients undergoing colectomies at Veterans Affairs (VA) hospitals versus non-VA hospitals. METHODS: After institutional review baord approval, records for 271,523 colectomies from NSQIP and 11,597 from VASQIP between the years 2015 and 2019 were compiled. Demographics, comorbidity, 30-d mortality, and other outcomes were examined using Chi-squared, analysis of variance, Mann Whitney U, and Fisher's Exact Test within SPSS version 26. RESULTS: VASQIP patients were more likely to be male (94.3% versus 48.4%, P < 0.001) and older (median 63, 52-72 versus 67, 60-72 P < 0.001). Veterans were also more likely to have diabetes (25.3% versus 15.8%, P < 0.001), chronic obstructive pulmonary disease (15.4% versus 5.5%, P < 0.001), and congestive heart failure (17.0% versus 1.3%, P < 0.001). Veterans had slightly better 30-d mortality (2.4% versus 2.8%, P = 0.003), less organ space infections (2.8% versus 5.8%, P < 0.001), or postoperative sepsis (3.4% versus 5.3%). Non-VA patients were more likely to be having emergent surgery (13.4% versus 9.6%, P < 0.001) or undergo a laparoscopic approach (57.9% versus 50.2%, P < 0.001). Non-VA patients had shorter postoperative length of stay (5.99 d versus 7.32 d, P < 0.001) and were less likely to return to the operating room (5.3% versus 8.4%, P < 0.001) CONCLUSIONS: Despite increased comorbidity, VA hospitals and hospitals enrolled in NSQIP have managed to achieve markedly similar rates of 30-d mortality following colectomy. Further study is needed to better understand the differences between both the populations and surgical outcomes between VA hospitals and non-VA hospitals.

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.

Trends in Resident Supervision and Patient Outcomes of Laparoscopic Cholecystectomies Within the Veterans Affairs Healthcare System.

OBJECTIVE: We sought to use the Veterans Affairs Surgical Quality Improvement Program (VASQIP) database to determine if there is an increase in morbidity or mortality when resident physicians independently perform laparoscopic cholecystectomy compared to when an attending surgeon is scrubbed. DESIGN: We performed a retrospective review of 54,144 cases of laparoscopic cholecystectomy performed within the Veterans Affairs (VA) Healthcare system from 2000 to 2020. Cases were divided into groups based on if the attending was scrubbed or not scrubbed. We then performed 1:1 case matching without replacement based on sex, race, and major comorbidities. PARTICIPANTS: Veterans over age 18 undergoing laparoscopic cholecystectomy within the VA healthcare system between 2000 and 2020. Cases were excluded if a resident was not involved in the surgery or if the level of autonomy was not defined. RESULTS: Significantly more operative cases were performed without the attending scrubbed before 2003 than after (14.6% vs 1.60%, p < 0.01). After matching, in 1464 (48.6%) cases the attending physician was scrubbed, and in 1549 (51.4%) the attending physician was not scrubbed. Patients were statistically similar in all measured comorbidities between the groups. Operative time was noted to be slightly longer when the attending was scrubbed (1.86 hours ± 0.79 vs 1.72 ± 0.67, p < 0.01) as well as increased complication rates (9.0% vs 6.1%, p < 0.01). No differences existed for 30-day mortality (0.8% vs 0.5%, p = 0.416), postoperative length of stay (2.7 days vs 2.96 days, p = 0.43), or superficial infection (1.9% vs 1.7%, p = 0.73). CONCLUSIONS: Our analysis of the VASQIP database indicates that decreased resident supervision during laparoscopic cholecystectomy has minimal impact on patient outcomes. Rates of resident independent operating have declined 10-fold since the early 2000's. Further research is required to better define the changes in resident surgical education and their impact on patient outcomes.

Complications Following Ulnar Artery Catheterization for Coronary Angiography.

BACKGROUND: Use of radial and ulnar access has increased due to its perceived benefits over femoral access. Ulnar artery catheterization can place patients at risk of significant complications, including pseudoaneurysm, expanding hematoma, compartment syndrome, ulnar nerve injury, and critical hand ischemia. The purpose of this study was to describe complications specific to ulnar artery catheterization. METHODS: After obtaining institutional review board approval, a retrospective review was performed on all patients who underwent ulnar artery catheterization at our institution between 2019 and 2021. Complications were assessed, and complication rates were compared with previously published studies on ulnar artery catheterization for coronary angiography (percutaneous coronary intervention). RESULTS: A total of 41 patients were available for review with a mean age of 59 years. Of these, 17 patients (41%) sustained complications in the immediate postprocedural period. These complications included hematoma (12 patients, 29%), pseudoaneurysm (1 patient, 2%), ulnar artery thrombosis (1 patient, 2%), ulnar neuropathy (3 patients, 7%), arterial damage requiring repair (2 patients, 5%), transient ischemia (3 patients, 7%), and compartment syndrome (2 patients, 5%). Three of these patients (7%) required operative intervention, and several were admitted to the hospital for an additional period of observation. CONCLUSIONS: This series highlights the significant risks associated with ulnar artery catheterization for percutaneous procedures. Complications include pseudoaneurysm, expanding hematoma, compartment syndrome, ulnar nerve damage, and critical hand ischemia. Several of these patients required urgent or emergent surgical intervention, with some patients experiencing ongoing ulnar nerve symptoms.

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.

Establishing 3D Printing at the Point of Care: Basic Principles and Tools for Success.

As the medical applications of three-dimensional (3D) printing increase, so does the number of health care organizations in which adoption or expansion of 3D printing facilities is under consideration. With recent advancements in 3D printing technology, medical practitioners have embraced this powerful tool to help them to deliver high-quality patient care, with a focus on sustainability. The use of 3D printing in the hospital or clinic at the point of care (POC) has profound potential, but its adoption is not without unanticipated challenges and considerations. The authors provide the basic principles and considerations for building the infrastructure to support 3D printing inside the hospital. This process includes building a business case; determining the requirements for facilities, space, and staff; designing a digital workflow; and considering how electronic health records may have a role in the future. The authors also discuss the supported applications and benefits of medical 3D printing and briefly highlight quality and regulatory considerations. The information presented is meant to be a practical guide to assist radiology departments in exploring the possibilities of POC 3D printing and expanding it from a niche application to a fixture of clinical care. An invited commentary by Ballard is available online. ©RSNA, 2022.

The COMET framework: A novel approach to design an escape room workshop for interprofessional objectives.

While recreational escape rooms have gained momentum across education and team training in multiple professions, few published escape room designs have been truly interprofessional. A major obstacle faced by educators and team leaders alike is the lack of any practical design framework for escape room development that is specific to meeting learning objectives. The COMET Framework (Context, Objectives, Materials, Execution, and Team Dynamics) was developed as a step-by-step approach to escape room design using general terminology and piloted in a one-hour workshop at a regional interprofessional conference. Surveys completed by participants suggest that application of the COMET framework increased understanding and confidence regarding escape room design regardless of prior experience with the format. The generality of the COMET framework may allow it to be utilized for team exercise design more broadly in the contexts of interprofessional training and faculty development.

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.

Peripheral nerve stimulation for the management of acute and subacute post-amputation pain: a randomized, controlled feasibility trial.

Introduction & aim: Temporary (60-day) percutaneous peripheral nerve stimulation (PNS) has demonstrated effectiveness for the treatment of chronic post-amputation pain, and this pilot study aims to evaluate the feasibility of temporary percutaneous PNS for the treatment of acute post-amputation pain. Patients & methods: Sixteen veterans undergoing lower extremity amputation received PNS and standard medical therapy or standard medical therapy alone. Results: The PNS group reported greater reductions in average phantom limb pain, residual limb pain and daily opioid consumption, and there were fewer participants taking opioids through 3 months post-amputation. Conclusion: This pilot study suggests that PNS is feasible in the acute postoperative period following lower limb amputation and may provide a non-pharmacologic analgesic therapy that lowers pain scores and reduces opioid consumption, and thus warrants further investigation.

A small study was done to evaluate placing a wire lead near a nerve to electrically stimulate it for 60 days after a leg amputation surgery to see if it helps reduce pain. The study looked at 16 veterans who had an amputation to their leg. These patients were divided into either a group that received nerve stimulation plus normal pain control medications or a group that just received pain medications. The group that received nerve stimulation had less pain in the remaining leg and less phantom pain (pain in the missing leg). They also required fewer narcotic medications. The study suggested that nerve stimulation may provide an effective way to manage pain after amputation and reduce the use of pain medications. Clinical Trial Registration Number: NCT03484429.

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.