A Comparison of Venaseal Versus Radiofrequency Ablation Outcomes Within a Managed Care Organization.

BACKGROUND: Chronic venous insufficiency is a common medical condition that afflicts over 30 million adults in the United States. Treatment and management have changed dramatically over the past 20 years with the introduction of various endovenous therapies, including radiofrequency ablation (RFA) and cyanoacrylate closure using the Venaseal system. In this study, we explore a direct comparison of outcomes between RFA and VenaSeal conducted by a single surgeon within a managed care organization. METHODS: Between May 2020 and December 2021, there were 87 patients undergoing 97 total procedures who were treated with either VenaSeal (n = 55) or RFA (n = 42), conducted by a single surgeon within a managed care organization. Primary outcomes included successful greater saphenous vein (GSV) closure, postoperative deep vein thrombosis (DVT), embolization, saphenofemoral junction (SFJ) thrombosis, skin reaction (allergic or thrombophlebitis), or procedure-related emergency room (ER) and urgent care (UC) visits. Retrospective chart review was conducted to describe patient demographics, indications for treatment, treatment details (number of access sites and indication for treatment), as well as follow-up adjunctive vein procedures (sclerotherapy and stab phlebectomy). RESULTS: All patients had postprocedural ultrasound (US) performed within 7 days by the operating surgeon and mean overall patient follow-up from index procedure was 12 months; 2 patients were lost to follow-up due to death. All operations utilized intraoperative US, and SFJ thrombosis was not observed in any patient postprocedure. The average age of VenaSeal and RFA groups was 59.05 and 59.51 years, respectively. The average number of access sites during the procedure for VenaSeal and RFA was 1.56 and 1.20, respectively. Of the 55 VenaSeal treatments, 9.1% of patients reported postoperative skin reactions, and 9.1% of patients underwent subsequent stab phlebectomy (22 stabs on average). Of the 42 RFA treatments, 7.1% of RFA patients reported postoperative skin reactions, and 9.5% underwent subsequent stab phlebectomy (36 stabs on average). The percentage of patients who had postoperative UC or emergency department visits related to the procedure in the VenaSeal and RFA groups was 3.6% and 0%, respectively. CONCLUSIONS: Both VenaSeal and RFA demonstrated effective vein closure of the GSV at 12-month follow-up, with VenaSeal demonstrating continued noninferiority to RFA. Based on our data, postoperative skin reactions do not appear to be significantly higher with VenaSeal treatment, as previously reported.

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.

COVID-19-related Peripheral Arterial Thrombosis Treated in a Large Health Maintenance Organization.

BACKGROUND: COVID-19 was initially identified as an acute respiratory disease, but it was quickly recognized that multiple organ systems could be affected. Venous thrombosis and pulmonary embolism have been well reported. However, there is a paucity of data on COVID-19-related arterial thrombosis. We examined the incidence, characteristics, treatment, and outcome in patients with acute COVID-19-related arterial thrombosis in a large health maintenance organization (HMO). METHODS: A retrospective multicenter case review was performed from March 2020 to March 2021. Cases were identified through a questionnaire sent to vascular surgeons. Patient characteristics, imaging, treatment, and outcome were reviewed. Successful revascularization was defined as restoration of blood flow with viability of the end organ and absence of death within 30 days. Limb salvage was defined as prevention of major amputation (transtibial or transfemoral) and absence of death in 30 days. RESULTS: There were 37,845 patients admitted with COVID-19 complications during this time. Among this group, 26 patients (0.07%) had COVID-19-related arterial thrombosis. The mean age was 61.7 years (range, 33-82 years) with 20 men (77%) and 6 women (23%). Ethnic minorities comprised 25 of 26 cases (96%). Peripheral arterial disease (PAD) was present in 4 of 26 (15%), active smoking in 1 of 26 (3.8%), and diabetes in 19 of 26 (73%) cases. Most patients developed acute arterial ischemia in the outpatient setting, 20 of 26 (77%). Of the outpatients, 6 of 20 (30%) had asymptomatic COVID-19 and 14 of 20 (70%) had only mild upper respiratory symptoms. Distribution of ischemia was as follows: 23 patients had at least one lower extremity ischemia, one patient had cerebral and lower extremity, one had mesenteric and lower extremity, and one had upper extremity ischemia. Revascularization was attempted in 21 patients, of which 12 of 21 (57%) were successful. Limb salvage was successful in 13 of 26 (50%) patients. The overall mortality was 31% (8/26). CONCLUSIONS: Our experience in a large HMO revealed that the incidence of COVID-19-related arterial thrombosis was low. The actual incidence is likely to be higher since our method of case collection was incomplete. The majority of arterial thrombosis occurred in the outpatient setting in patients with asymptomatic or mild/moderate COVID-19 respiratory disease. Acute ischemia was the inciting factor for hospitalization in these cases. Acute lower extremity ischemia was the most common presentation, and limb salvage rate was lower than that expected when compared to ischemia related to PAD. Arterial thrombosis associated with COVID-19 portends a significantly higher mortality. Education of primary care providers is paramount to prevent delayed diagnosis as most patients initially developed ischemia in the outpatient setting and did not have a high cardiovascular risk profile.

Staple aneurysmorrhaphy to salvage autogenous arteriovenous fistulas with aneurysm-related complications.

OBJECTIVE: Aneurysm-related complications could lead to loss of a functioning arteriovenous fistula (AVF). We report our midterm and long-term results with the staple aneurysmorrhaphy technique to repair and preserve aneurysmal AVFs. METHODS: We retrospectively reviewed our surgical treatment of patients with aneurysmal autogenous AVF complicated by skin erosion, bleeding, infection, pain, and difficulty with needle access from 2007 through 2014. We identified 52 patients, 40 (77%) of whom underwent repair with the staple aneurysmorrhaphy technique. The operation involved mobilizing the entire aneurysmal segments. A TA (Covidien, Norwalk, Conn) or Endo GIA (Covidien, Mansfield, Mass) stapler was used to resect the redundant aneurysm wall to create a 6- to 8-mm-diameter conduit. A subcutaneous skin flap was created after excising compromised skin. The remodeled vein was repositioned underneath the subcutaneous flap, with the staple line rotated laterally to avoid needle puncture. RESULTS: We attempted staple aneurysmorrhaphy in 40 patients with complicated AVF aneurysms, of which 38 repairs (95%) were successful. Median patient age was 66 years (range, 29-88 years). Median AVF age was 63 months (range, 12-136 months). Median follow-up was 20 months (range, 5-81 months). At 1 year, primary patency was 67%, assisted primary patency was 88%, and secondary patency was 91%. At 2 years, primary patency was 59%, assisted primary patency was 84%, and secondary patency was 91%. At 3 years, primary patency was 46%, assisted primary patency was 69%, and secondary patency was 85%. Surgery was performed under local-regional anesthesia in 28 patients (70%) and under general anesthesia in the remaining 12 (30%). Proximal venous outflow stenoses were detected in 19 of 40 AVFs (48%) preoperatively and in 11 of 38 AVFs (29%) postoperatively. Aneurysm recurrence occurred in two repaired AVFs. CONCLUSIONS: Our experience with staple aneurysmorrhaphy shows that it is an effective, safe, and durable procedure to preserve a functioning autogenous AVF with complicated aneurysmal degeneration. Key principles are to reduce the vein to normal adjacent diameter and to provide healthy skin coverage. The remodeled AVF has a low aneurysm recurrence rate and maintains the beneficial properties of superior patency and low infection. It is important to aggressively monitor for and treat proximal outflow venous stenoses to prevent aneurysm recurrence. The surgery can be done safely under local anesthesia in selected patients.

Use of the GORE Conformable Excluder Device in Highly Angulated Aortic Neck Anatomy: Mid-term Outcomes.

INTRODUCTION: Patients with complex aortic anatomy require meticulous surgical planning to optimize intraoperative and postoperative outcomes. The GORE Excluder Conformable Abdominal Aortic Aneurysm Endoprosthesis (CEXC Device, WL Gore and Associates, Flagstaff, AZ) allows for endovascular treatment of highly angulated and short proximal neck abdominal aortic aneurysms (AAA). Owing to its recent approval, short-term clinical outcomes of this device remain scarce. REPORT: In this report, we present a case series of 3 patients who underwent endovascular aortic repair using the GORE Excluder Conformable device with highly angulated (>70°) aortic neck anatomy. Endografts were deployed in a radiology suite using standard 2D angiography in conjunction with a CYDAR Medical (Wilmington, Delaware) reconstructed 3D overlay. The patients' ages were 85, 67, and 85 years. The mean abdominal aortic aneurysm diameter in these cases was 6.9 cm. The mean proximal neck length was 2.1 cm, proximal mean neck angulation was 83°. The mean operative time, total fluoroscopy time, and contrast used were 208 minutes, 28.3°minutes, and 94.5 milliliters, respectively. No adjunctive procedures, such as proximal cuff or endo-anchors, were performed at the time of index procedure. DISCUSSION: Type Ia endoleak was observed in 1 patient post-operatively but after treatment with an aortic cuff there was no evidence of enlarging aneurysm sac. The GORE Excluder Conformable Endoprosthesis expands access to endovascular management of AAAs. Our early experience with this device demonstrated excellent patient and clinical outcomes in a highly angulated neck anatomy.