The Use of Advanced Three-Dimensional Computed Tomography During Simple and Complex Endovascular Aortic Aneurysm Repairs.

BACKGROUND: Endovascular aneurysm repair (EVAR) success depends on imaging technology both in the planning and operative phases. Endovascular repair requires intravenous contrast and radiation exposure to the patient as well as radiation exposure to the operator. Recent developments in imaging technology attempt to merge preoperative imaging with intraoperative imaging to improve the efficiency and accuracy of EVAR. The Cydar 3-dimensional (3D) imaging system combines the preoperative and intraoperative imaging during the operation. We aim to investigate the use of the Cydar 3D imaging system during EVAR compared to conventional methods. METHODS: Retrospective review of all patients undergoing an EVAR at a single quaternary vascular center from 2019-2023 was collected. This cohort was divided into 2 groups: (1) repair using Cydar 3D imaging or (2) repair without Cydar 3D imaging. Overall, 138 unique patients were identified with 27 operations using Cydar 3D imaging and 111 operations without Cydar 3D imaging. We performed a 1-to-1 propensity score-matched analysis using nearest-neighbor matching for variables including age, case urgency, and if the case was performed in the operative room or interventional radiology room. A match occurred when a patient in the Cydar 3D imaging group had an estimated score within 0.01 standard deviations of a patient in the control group. From this, we paired 27 from each cohort for a total of 54 patients. Demographic data included length of stay in days, contrast volume (mL), fluoroscopy time (min), procedure length (mins), mortality, and blood loss (mL). Univariate analyses were performed and a P value less than 0.05 was considered statistically significant. RESULTS: A total of 54 vascular patients were analyzed: 27 without the Cydar 3D imaging and 27 with the Cydar 3D imaging. In the univariate analysis, there was no statistical difference in the average length of stay (6.4 days ± 11.76 vs. 4.1 ± 6.03, P = 0.372), aneurysm size (5.9 ± 1.4 vs. 5.9 ± 1.2, P = 0.88), contrast volume in mL (91.3 ± 47.0 vs. 91.1-33.49, P = 9.88), fluoroscopy time in mins (20.2 ± 17.2 vs. 19.5 ± 19.4, P = 0.89), procedure length (299.3 ± 177.9 vs. 353 ± 191.98, P = 0.279), and blood loss in mL (513.8 ± 791 vs. 353 ± 191.98, P = 0.594). There was an increase in reintervention for endoleaks in the group with use of Cydar 3D imaging (0 vs. 6, P = 0.043). A subanalysis of patients undergoing physician-modified EVARs did show a 15% reduction in the contrast volume used. CONCLUSIONS: The use of 3D imaging technology has the potential to increase the safety of EVAR to both patients and operators. In our study, we did not find any difference in standard EVARs; however, there was a contrast use decrease in physician-modified EVARs. Further studies will need to be performed to determine the realized benefit from performing EVARs using this new technology.

Risk for surgical interventions following endovascular aneurysm repair with Endologix AFX or AFX2 Endovascular AAA Systems compared with other devices.

OBJECTIVE: To evaluate the risk for 90-day returns to care and long-term subsequent surgical interventions after primary endovascular aneurysm repair (EVAR) with an Endologix AFX Endovascular AAA System compared with three other high-volume endograft devices. METHODS: We conducted a matched cohort study using data from Kaiser Permanente's Endovascular Stent Graft Registry. Patients aged ≥18 years who underwent primary EVAR for AAA in the health care system from January 1, 2011, to December 31, 2017, comprised the eligible study sample. The treatment group included patients who received an Endologix AFX or AFX2 device (n = 470). Patients who received one of three other high-volume endograft devices used within the health care system comprised the eligible comparison group (n = 2122). These patients were 2:1 propensity score matched without replacement to patients who received an Endologix device based on a number of patient and procedural characteristics. After the application of matching, conditional logistic regression was used to evaluate the likelihood for 90-day emergency department visit and readmission. Cause-specific Cox regression was used to evaluate the long-term risk of endoleak, graft revision, secondary reintervention (not including revision), conversion to open repair, and rupture during follow-up. Cox proportional hazards regression was used to evaluate the risk of mortality (overall and aneurysm related). RESULTS: The final matched study sample included 470 patients who received an Endologix AFX or AFX2 device and 940 patients who received a different high-volume device. compared with the other devices, AFX/AFX2 had a higher risk for type III endoleak (hazard ratio [HR], 38.79; 95% confidence interval [CI], 14.51-103.67), revision surgery >1 year after the primary EVAR (HR, 4.50; 95% CI, 3.10-6.54), rupture (HR, 6.52; 95% CI, 1.73-24.63), and aneurysm-related mortality (HR, 2.43; 95% CI, 1.32-4.47) was observed with the use of AFX/AFX2. CONCLUSIONS: In our matched cohort study, patients who received an Endologix AFX System during their primary EVAR had a higher risk for several adverse longitudinal outcomes, as well as aneurysm-related mortality, when compared with patients who received other high-volume devices. Patients who have received these devices should be monitored closely after EVAR.

Decreasing trends in reintervention and readmission after endovascular aneurysm repair in a multiregional implant registry.

OBJECTIVE: As endovascular aortic aneurysm repair (EVAR) matures into its third decade, measures such as long-term reintervention and readmission have become a focus of quality improvement efforts. Within a large United States integrated health care system, we describe time trends in the rates of long-term reinterventions utilization measures. METHODS: Data from a United States multiregional EVAR registry was used to perform a descriptive study of 3891 adults who underwent conventional infrarenal EVAR for infrarenal abdominal aortic aneurysm between 2010 and 2019. Three-year follow-up was 96.7%. Outcomes included 1-, 3-, and 5-year graft revision (defined as a procedure involving placement of a new endograft component), secondary interventions (defined as a procedure necessary for maintenance of EVAR integrity [eg, coil embolization and balloon angioplasty/stenting]), conversion to open, interventions for type II endoleaks alone, and 90-day readmission. Crude cause-specific reintervention probabilities were calculated by operative year using the Aalen-Johansen estimator, with death as a competing risk and December 31, 2020 as the study end date. RESULTS: Excluding interventions for type II endoleak alone, 1-year secondary intervention incidence decreased from 5.9% for EVARs in 2010 to 2.0% in 2019 (P < .001) and 3-year incidence decreased from 7.2% to 3.6% from 2010 to 2017 (P = .03). The 3-year incidences of graft revision (mean incidence, 3.4%) and conversion to open remained fairly stable (mean incidence, 0.6%) over time. The 3-year incidence of interventions for type II endoleak alone also decreased from 3.4% in 2010 to 0.7% in 2017 (P = .01). Ninety-day readmission rates decreased from 19.3% for index EVAR in 2010 to 9.2% in 2019 (P = .03). CONCLUSIONS: Comprehensive data from a multiregional health care system demonstrates decreasing long-term secondary intervention and readmission rates over time in patients undergoing EVAR. These trends are not explained by evolving management of type II endoleaks and suggest improving graft durability, patient selection, or surgical technique. Further study is needed to define implant and anatomic predictors of different types of long-term reintervention.

Cost-effectiveness of dehydrated human amnion/chorion membrane allografts in lower extremity diabetic ulcer treatment.

OBJECTIVE: To evaluate the cost-effectiveness and budget impact of using standard care (no advanced treatment, NAT) compared with an advanced treatment (AT), dehydrated human amnion/chorion membrane (DHACM), when following parameters for use (FPFU) in treating lower extremity diabetic ulcers (LEDUs). METHOD: We analysed a retrospective cohort of Medicare patients (2015-2019) to generate four propensity-matched cohorts of LEDU episodes. Outcomes for DHACM and NAT, such as amputations, and healthcare utilisation were tracked from claims codes, analysed and used to build a hybrid economic model, combining a one-year decision tree and a four-year Markov model. The budget impact was evaluated in the difference in per member per month spending following completion of the decision tree. Likewise, the cost-effectiveness was analysed before and after the Markov model at a willingness to pay (WTP) threshold of $100,000 per quality adjusted life year (QALY). The analysis was conducted from the healthcare sector perspective. RESULTS: There were 10,900,127 patients with a diagnosis of diabetes, of whom 1,213,614 had an LEDU. Propensity-matched Group 1 was generated from the 19,910 episodes that received AT. Only 9.2% of episodes were FPFU and DHACM was identified as the most widely used AT product among Medicare episodes. Propensity-matched Group 4 was limited by the 590 episodes that used DHACM FPFU. Episodes treated with DHACM FPFU had statistically fewer amputations and healthcare utilisation. In year one, DHACM FPFU provided an additional 0.013 QALYs, while saving $3,670 per patient. At a WTP of $100,000 per QALY, the five-year net monetary benefit was $5003. CONCLUSION: The findings of this study showed that DHACM FPFU reduced costs and improved clinical benefits compared with NAT for LEDU Medicare patients. DHACM FPFU provided better clinical outcomes than NAT by reducing major amputations, ED visits, inpatient admissions and readmissions. These clinical gains were achieved at a lower cost, in years 1-5, and were likely to be cost-effective at any WTP threshold. Adoption of best practices identified in this retrospective analysis is expected to generate clinically significant decreases in amputations and hospital utilisation while saving money.

Midterm outcomes for 605 patients receiving Endologix AFX or AFX2 Endovascular AAA Systems in an integrated healthcare system.

BACKGROUND: Endologix issued important safety updates for the AFX Endovascular AAA System in 2016 and 2018 owing to the risk of type III endoleaks. Outcomes with these devices are limited to small case series with short-term follow-up. We describe the midterm outcomes for a large cohort of patients who received an Endologix AFX or AFX2 device. STUDY DESIGN: Data from an integrated healthcare system's implant registry, which prospectively monitors all patients after endovascular aortic repair, was used for this descriptive study. Patients undergoing endovascular aortic repair with three AFX System variations (Strata [AFX-S], Duraply [AFX-D], and AFX2 with Duraply [AFX2]) were identified (2011-2017). Crude cumulative event probabilities for endoleak (types I and III), major reintervention, conversion to open, rupture, and mortality (aneurysm related and all cause) were estimated. RESULTS: Among 605 patients, 375 received AFX-S, 197 received AFX-D, and 33 received AFX2. Median follow-up for the cohort was 3.9 (interquartile range, 2.5-5.1) years. The crude 2-year incidence of overall endoleak, any subsequent reintervention or conversion, and mortality was 8.8% (95% confidence interval [CI], 6.3-12.3), 12.0% (95% CI, 9.1-15.9), and 8.8% (95% CI, 6.3-12.2) for AFX-S. Respective estimates for AFX-D were 7.9% (95% CI, 4.8-13.0), 10.6% (95% CI, 6.9-16.1), and 9.7% (95% CI, 6.3-14.7); for AFX2, they were 14.1% (95% CI, 4.7-38.2), 16.2% (95% CI, 6.4-37.7), and 21.2% (95% CI, 10.7-39.4). CONCLUSIONS: The midterm outcomes of a large U.S. patient cohort with an Endologix AFX or AFX2 System demonstrate a concerning rate of adverse postoperative events. Patients with these devices should receive close clinical surveillance to prevent device-related adverse events.

Observed impact of skin substitutes in lower extremity diabetic ulcers: lessons from the Medicare Database (2015-2018).

OBJECTIVE: To evaluate large propensity-matched cohorts to assess outcomes in patients receiving advanced treatment (AT) with skin substitutes for lower extremity diabetic ulcers (LEDUs) versus no AT (NAT) for the management of LEDUs. METHOD: The Medicare Limited Dataset (1 October 2015 through 2 October 2018) were used to retrospectively analyse people receiving care for a LEDU treated with AT or NAT (propensity-matched Group 1). Analysis included major and minor amputations, emergency department (ED) visits and hospital readmissions. In addition, AT following parameters for use (FPFU) was compared with AT not FPFU (propensity-matched Group 2). A paired t-test was used for comparisons of the two groups. For comparisons of three groups, the Kruskal-Wallis test was used. A Bonferroni correction was performed when multiple comparisons were calculated. RESULTS: There were 9,738,760 patients with a diagnosis of diabetes, of whom 909,813 had a LEDU. In propensity-matched Group 1 (12,676 episodes per cohort), AT patients had statistically fewer minor amputations (p=0.0367), major amputations (p<0.0001), ED visits (p<0.0001), and readmissions (p<0.0001) compared with NAT patients. In propensity-matched Group 2 (1131 episodes per cohort), AT FPFU patients had fewer minor amputations (p=0.002) than those in the AT not FPFU group. CONCLUSION: AT for the management of LEDUs was associated with significant reductions in major and minor amputation, ED use, and hospital readmission compared with LEDUs managed with NAT. Clinics should implement AT in accordance with the highlighted parameters for use to improve outcomes and reduce costs.

The Kaiser Permanente experience with ultrasound-guided percutaneous endovascular abdominal aortic aneurysm repair.

BACKGROUND: This study was conducted to determine the effect of ultrasound (US)-guided percutaneous access for percutaneous endovascular abdominal aortic aneurysm repair (PEVAR) on conversion to open repair by femoral cutdown. We also sought to identify other risk factors associated with failure of percutaneous access and conversion to femoral cutdowns. METHODS: This is a single-center, retrospective review of 101 patients who underwent PEVAR between January 1, 2005 and July 31, 2009 (56 months). Risk factors that were evaluated for unsuccessful PEVAR included gender, age (≤65 and ≥66 years), US-guided percutaneous access, mechanical failure, abdominal aortic aneurysm size, and the following comorbidities: diabetes, hypertension, vessel calcification, and obesity (body mass index: ≥30 kg/m(2)). RESULTS: There were 10 (9.9%) conversions from percutaneous to femoral cutdown, yielding a success rate of 90.1% for a total percutaneous approach. Each converted patient had one groin converted, resulting in a cutdown rate per groin of 10/202 (5%). There were no 30-day mortalities. Univariate analysis showed that hypertension (P = 0.261), age ≥66 years (P = 0.741), current smoking history (P = 0.649), past smoking history (P = .093), diabetes (P = 0.908), vessel calcification (P = 0.8281), and body mass index ≥30 kg/m(2) (P = 0.052) did not significantly predict conversion to endovascular aortic aneurysm repair (EVAR). Mechanical failure significantly predicted conversion to cutdown EVAR (P = 0.0002), whereas US-guided percutaneous access influenced successful PEVAR (P = 0.030). Multivariate analysis showed that mechanical failure significantly predicted conversion to cutdown EVAR (P = 0.003) and US-guided percutaneous access influenced successful PEVAR (P = 0.040) after adjusting for smoking history and obesity. CONCLUSION: PEVAR is a viable option for aortic aneurysm repair that may be improved with US-guided percutaneous access by reducing the rate of femoral cutdowns.

A collaborative approach to teaching medical students how to screen, intervene, and treat substance use disorders.

Few medical schools require a stand-alone course to develop knowledge and skills relevant to substance use disorders (SUDs). The authors successfully initiated a new course for second-year medical students that used screening, brief intervention, and referral to treatment (SBIRT) as the course foundation. The 15-hour course (39 faculty teaching hours) arose from collaboration between faculty in Departments of Medicine and Psychiatry and included 5 hours of direct patient interaction during clinical demonstrations and in small-group skills development. Pre- and post-exam results suggest that the course had a significant impact on knowledge about SUDs. The authors' experience demonstrates that collaboration between 2 clinical departments can produce a successful second-year medical student course based in SBIRT principles.

Bifurcated endograft repair of ilio-iliac arteriovenous fistula secondary to lumbar diskectomy.

Ilio-iliac arteriovenous (AV) fistula is a rare complication after lumbar diskectomy. Endovascular repair of such fistulas is a growing trend in vascular surgery. This is a case report of an endovascular exclusion of an ilio-iliac AV fistula in a 51-year-old male. This man presented with high-output congestive heart failure and ascites. The AV fistula was discovered 17 years after a lumbar diskectomy. Computed topography (CT) revealed a right common iliac artery pseudoaneurysm connecting to the left common iliac vein. The fistula was repaired using a bifurcated Gore Excluder endograft. There were follow-up CT scans at 6 and 10 months confirming exclusion of the AV fistula. Endovascular AV fistula repair offers a safe, effective method for managing ilio-iliac AV fistulas.

Retrograde superior mesenteric artery stenting for acute mesenteric arterial thrombosis.

Retrograde superior mesenteric artery stenting (ROMS) represents a significant development in the treatment of acute mesenteric ischemia. Compared to traditional surgical mesenteric bypass, ROMS is a less invasive technique that avoids many complications associated with emergent mesenteric bypass. This case report illustrates that retrograde superior mesenteric artery (SMA) stenting is an option for the treatment of acute mesenteric ischemia for patients in extremis.

Simulator assessment of innate endovascular aptitude versus empirically correct performance.

OBJECTIVE: Prior work has established that performance on an endovascular simulator incorporating tactile feedback (haptics) correlates with previous endovascular experience and can be improved by training. This study was designed to test the ability to define and measure innate endovascular aptitude and empirically correct performance and to determine whether these are two different things. METHODS: Subjects ranging in endovascular skill level from novice to expert were surveyed to determine video game experience and skill, endovascular level of training, and endovascular experience. They were then tested by using a standard protocol requiring timed advancement of a catheter and wire sequentially into each of three vessels arising from a simulated type I arch. Recorded trials were independently and blindly scored by two experienced endovascular faculty members by using a modification of a previously validated scale (Modified Reznick Scale; MRS). Summed scores were analyzed by frequency analysis and categorized as satisfactory and unsatisfactory on the basis of a clear bimodal distribution. Categorical outcome, time to task completion, and other variables were analyzed by means of linear regression, analysis of variance, and Welch modified two-sample t tests, as indicated. RESULTS: A total of 61 subjects were enrolled: 42% students, 8% technicians, 19% surgeons, 13% cardiologists, and 18% radiologists. Of these, 62% were considered novices and 30% experts on the basis of previous experience; 56% of subjects worked in an endovascular-related occupation. MRS scores were highly correlated between raters (P < .0001) and showed a clear bimodal distribution, with subjects in any endovascular occupation (including technicians) scoring significantly better than all others (P < .0001). Hours of video games played per week were correlated highly with completion times (P < .001) and MRS scores (P < .001). Measures of formal training (number of endovascular cases and occupation) correlated highly with completion times (all P < .03) and MRS scores (all P < .008). In comparing completion times vs MRS scores, three groups were apparent: unskilled-inexperienced, skilled-inexperienced, and skilled-experienced, corresponding primarily to senior subjects without endovascular experience, younger subjects without endovascular experience, and formally trained endovascular physicians, respectively. Those judged intermediate in aptitude reduced times to the lowest possible level before improving their MRS scores. CONCLUSIONS: Although inherently subjective, the MRS yields reproducible scores that correlate with endovascular experience and formal training. Experts and novices with extensive video game experience achieve short completion times, whereas high MRS scores are achieved only by formally trained subjects. Innate endovascular aptitude and empirically correct performance may be two separate things, and aptitude may be acquirable through (or identified by) extensive nonmedical video game experience.

Stacked proximal aortic cuffs: an "off-the-shelf" solution for treating focal thoracic aortic pathology.

PURPOSE: To report our early experience with the endovascular placement of stacked Zenith main body extensions (cuffs) in the treatment of focal thoracic aortic pathology in high-risk patients. METHODS: Between January 2003 and May 2004, 6 patients (3 men; mean age 59 years, range 37-82) with focal aortic pathology underwent endovascular repair using stacked 30 and 32-mm-diameter Zenith main body extensions. The setting was a university tertiary referral center for vascular disease. Indication for treatment included 2 descending thoracic aneurysms and individual cases of traumatic thoracic tear, diverticulum of Kommerell, thoracic pseudoaneurysm, and aortoesophageal fistula. RESULTS: All procedures were performed successfully, with a mean of 3 cuffs used. The patient with an aortoesophageal fistula expired after successful cuff placement due to sequela of massive pretreatment hemorrhage; fistula coverage was confirmed at autopsy. There were no type I endoleaks. Morbidity included an occluded right subclavian artery from traumatic passage of the device through the artery. No left subclavian arteries were covered. No neurological deficits or paraplegia was observed. The cuffs were patent in all surviving patients at an average follow-up of 7 months (range 3-12). Computed tomography in all survivors confirmed adequate cuff placement, absence of endoleak, and lack of cuff migration. Based on this experience, the following technical recommendations are offered: (1) right subclavian cutdown when needed to reach a lesion beyond the range of the sheath, (2) Dacron chimney placement, (3) stiff guidewire usage, (4) wire placement from the right subclavian artery through the common femoral artery if necessary to ease a sharp bend in the arch, and (5) cuff overlap of 25% to 50%. CONCLUSIONS: In high-risk patients, focal aortic pathology can be successfully treated with off-the-shelf commercially available cuffs using a stacking technique with acceptable mortality, morbidity, and short-term durability.

Use of computer simulation for determining endovascular skill levels in a carotid stenting model.

OBJECTIVES: The purpose of this study was to determine whether performance on a simulator model of carotid artery stenting correlates with previous endovascular experience and to assess the effects of repetition and training. METHODS: Participants were stratified to untrained and advanced skill groups on the basis of number of endovascular procedures previously performed. Baseline performance was assessed by means of a pretest, and participants were randomized to practice and no-practice groups. Practice consisted of a 30-minute to 60-minute proctored session before taking a final test; those in the no-practice group proceeded directly to the final test without this session. Primary outcomes were completion of a standardized protocol and the length of time needed to complete all steps. RESULTS: Twenty-nine subjects (16 untrained, 13 advanced) participated fully in the study. Ninety-two percent of participants in the advanced group successfully completed the pretest, versus 63% in the untrained group (P = .09); mean time to successful completion was 29.9 +/- 4.8 (mean +/- SD) versus 48.0 +/- 9.9 minutes, respectively (P < .001). Subjects who received no practice did not significantly improve their completion times between pretest and final test, whereas those who received practice did (novice, 47.9 +/- 7.0 minutes vs 24.5 +/- 2.9 minutes, P < .001; advanced, 29.6 +/- 3.1 minutes vs 20.2 +/- 4.1 minutes, P < .001). The group without previous training had significantly more time improvement from training than did the advanced group. Exit survey results showed that those who had the opportunity to practice more commonly believed that the simulator increased their endovascular skills and interest in vascular surgery (both P < .01 vs untrained group). CONCLUSIONS: Performance on the carotid stenting simulator correlated with previous endovascular experience. Although both novice and advanced groups improved their time after a 30-minute to 60-minute proctored training session, improvement in the novice group was greater than that in the advanced group, which suggests that novices may benefit disproportionately from this type of training.