What is the MAUDE database telling us about 510(k) authorization? Evaluation of Two Generations of Endovascular Arteriovenous Fistula Devices.

OBJECTIVES: In 2019, Bard Peripheral Vascular Inc (BV; now Becton, Dickinson and Company; Sparks, Maryland) received FDA approval to begin marketing the 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 (MAUDE) was queried for all adverse report events for the WavelinQ™ EndoAVF System and WavelinQ™ 4F EndoAVF System. Data was collected on patient issues and device issues. Fisher's Exact test was utilized. RESULTS: There was 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). CONCLUSION: 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 MAUDE 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.

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.

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.

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.