Safety and Efficacy of Endovenous Ablation in Patients with a History of Deep Venous Thrombosis.

OBJECTIVE: Endovenous ablation is the standard of care for patients with symptomatic superficial venous insufficiency. For patients with a history of deep venous thrombosis (DVT), there is concern for an increased risk of post-procedural complications, particularly venous thromboembolism (VTE). The objective of this study was to evaluate the safety and efficacy of endovenous thermal ablation in patients with a history of DVT. METHODS: The national Vascular Quality Initiative (VQI) Varicose Vein Registry (VVR) was queried for superficial venous procedures performed from January 2014-July 2021. Limbs treated with radiofrequency or laser ablation were compared between patients with and without a DVT history. The primary safety endpoint was incident DVT or endothermal heat-induced thrombosis (EHIT) II-IV in the treated limb at <3-month follow-up. Secondary safety endpoints included any proximal thrombus extension (i.e., EHIT I-IV), major bleeding, hematoma, pulmonary embolism (PE), and death due to the procedure. The primary efficacy endpoint was technical failure (i.e., recanalization at <1-week follow-up). Secondary efficacy endpoints included the risk of recanalization over time and the post-procedural change in quality-of-life measures. Outcomes by pre-operative use of anticoagulation (AC) were also compared among those with prior DVT. RESULTS: Among 33,892 endovenous thermal ablations performed on 23,572 individual patients aged 13-90, 1,698 patients (7.2%) had a history of DVT. Patients with prior DVT were older (p<0.001), of higher BMI (p<0.001), more likely to be male at birth (p<0.001) and black/African American (p<0.001), and had greater CEAP classifications (p<0.001). A history of DVT conferred higher risk of new DVT (1.4% vs. 0.8%, p=0.03), proximal thrombus extension (2.3% vs. 1.6%, p=0.045), and bleeding (0.2% vs. 0.04%, p=0.03). EHIT II-IV, PE, and hematoma risk did not differ by DVT history (p=NS). No deaths from treatment occurred in either group. Continuing pre-operative AC in patients with prior DVT did not change the risk of any complications after endovenous ablation (p=NS) but did confer increased hematoma risk among all endovenous thermal ablations and surgeries (p=0.001). Technical failure was similar between groups (2.0% vs. 1.2%, p=0.07), though a history of DVT conferred increased recanalization risk over time (HR=1.90, 95% CI [1.46, 2.46]), p<0.001). Groups had comparable improvement in post-procedural VCSS/HASTI scores (p=NS). CONCLUSIONS: Endovenous thermal ablation in patients with a history of DVT was effective. However, appropriate patient counseling regarding a heightened DVT risk, albeit still low, is critical. The decision to continue or withhold AC pre-operatively should be tailored on a case-by-case basis.

Generative artificial intelligence chatbots may provide appropriate informational responses to common vascular surgery questions by patients.

OBJECTIVES: Generative artificial intelligence (AI) has emerged as a promising tool to engage with patients. The objective of this study was to assess the quality of AI responses to common patient questions regarding vascular surgery disease processes. METHODS: OpenAI's ChatGPT-3.5 and Google Bard were queried with 24 mock patient questions spanning seven vascular surgery disease domains. Six experienced vascular surgery faculty at a tertiary academic center independently graded AI responses on their accuracy (rated 1-4 from completely inaccurate to completely accurate), completeness (rated 1-4 from totally incomplete to totally complete), and appropriateness (binary). Responses were also evaluated with three readability scales. RESULTS: ChatGPT responses were rated, on average, more accurate than Bard responses (3.08 ± 0.33 vs 2.82 ± 0.40, p < .01). ChatGPT responses were scored, on average, more complete than Bard responses (2.98 ± 0.34 vs 2.62 ± 0.36, p < .01). Most ChatGPT responses (75.0%, n = 18) and almost half of Bard responses (45.8%, n = 11) were unanimously deemed appropriate. Almost one-third of Bard responses (29.2%, n = 7) were deemed inappropriate by at least two reviewers (29.2%), and two Bard responses (8.4%) were considered inappropriate by the majority. The mean Flesch Reading Ease, Flesch-Kincaid Grade Level, and Gunning Fog Index of ChatGPT responses were 29.4 ± 10.8, 14.5 ± 2.2, and 17.7 ± 3.1, respectively, indicating that responses were readable with a post-secondary education. Bard's mean readability scores were 58.9 ± 10.5, 8.2 ± 1.7, and 11.0 ± 2.0, respectively, indicating that responses were readable with a high-school education (p < .0001 for three metrics). ChatGPT's mean response length (332 ± 79 words) was higher than Bard's mean response length (183 ± 53 words, p < .001). There was no difference in the accuracy, completeness, readability, or response length of ChatGPT or Bard between disease domains (p > .05 for all analyses). CONCLUSIONS: AI offers a novel means of educating patients that avoids the inundation of information from "Dr Google" and the time barriers of physician-patient encounters. ChatGPT provides largely valid, though imperfect, responses to myriad patient questions at the expense of readability. While Bard responses are more readable and concise, their quality is poorer. Further research is warranted to better understand failure points for large language models in vascular surgery patient education.

Venous ablation procedures by provider type, including advanced practice providers.

OBJECTIVE: The necessary training and certification of providers performing venous ablation has become a topic of debate in recent years. As venous interventions have shifted away from the hospital, the diversity of provider backgrounds has increased. We aimed to characterize superficial venous ablation practice patterns associated with different provider types. METHODS: We analyzed Medicare Fee-For-Service data from 2010 through 2018. Procedures were identified by their Current Procedural Terminology code and included radiofrequency ablation, endovenous laser ablation, chemical adhesive ablation (ie, VenaSeal; Medtronic, Inc), and mechanochemical ablation. These procedures were correlated with the practitioner type to identify provider-specific trends. RESULTS: Between 2010 and 2018, the number of ablation procedures increased by 107% from 114,197 to 236,558 per year (P < .001). Most procedures were performed by surgeons without vascular board certification (28.7%; 95% confidence interval [CI], 28.7%-28.8%), followed by vascular surgeons (27.1%; 95% CI, 27.0%-27.2%). Traditionally noninterventional specialties, which exclude surgeons, cardiologists, and interventional radiologists, accounted for 14.1% (95% CI, 14.1%-14.2%), and APPs accounted for 3.5% (95% CI, 3.4%-3.5%) of all ablation procedures during the study period. The total number of ablations increased by 9.7% annually (95% CI, 9.7%-9.8%), whereas procedures performed by APPs increased by 62.0% annually (95% CI, 61.6%-62.4%). There were significant differences between specialties in the use of nonthermal ablation modalities: APPs had the highest affinity for nonthermal ablation (odds ratio [OR], 2.60; 95% CI, 2.51-2.69). Cardiologists were also more likely to use nonthermal ablation (OR, 1.62; 95% CI, 1.59-1.66). Similarly, the uptake of new nonthermal technology (ie, chemical adhesives) was greatest among APPs (OR, 3.57; 95% CI, 3.43-3.70) and cardiologists (OR, 1.86; 95% CI, 1.81-1.91). Vascular surgeons were less likely to use nonthermal modalities (OR, 0.95; 95% CI, 0.92-0.97), including new nonthermal technology in the first year of availability (OR, 0.93; 95% CI, 0.90-0.95). CONCLUSIONS: The use of venous procedures has increased rapidly during the past decade, particularly as endovenous ablations have been performed by a wider practitioner base, including APPs and noninterventionalists. Practice patterns differ by provider type, with APPs and cardiologists skewing more toward nonthermal modalities, including more rapid uptake of new nonthermal technology. Provider-specific biases for specific ablation modalities might reflect differences in training, skill set, the need for capital equipment, clinical privileges, or reimbursement. These data could help to inform training paradigms, the allocation of resources, and evaluation of appropriateness in a real-world setting.

A registry-based study of paclitaxel drug-coated balloon angioplasty for the treatment of in-stent restenosis of the femoral-popliteal artery.

OBJECTIVE: The aim of this study was to report the results of a prospective, single-arm, registry-based study assessing the safety and performance of a paclitaxel drug-coated balloon (DCB) for the treatment of superficial femoral artery (SFA) or popliteal artery in-stent restenosis (ISR) in a United States population. METHODS: We conducted a prospective, non-randomized, multi-center, single-arm, post-market registry of the IN.PACT Admiral DCB for the treatment of ISR lesions in the SFA or popliteal artery at 43 sites within the Society for Vascular Surgery (SVS) Vascular Quality Initiative (VQI) Registry from December 2016 to January 2020. Clinical outcomes were assessed at 12, 24, and 36 months. The primary endpoint was target lesion revascularization at 12 months. Secondary endpoints included technical success, target vessel revascularization, major limb amputation, and all-cause mortality. Results are presented as survival probabilities based on Kaplan-Meier survival estimates. RESULTS: Patients (N = 300) were 58% male, with a mean age of 68 ± 10 years. Diabetes was present in 56%, 80% presented with claudication, and 20% with rest pain. Lesions included ISR of the SFA in 68%, SFA-popliteal in 26%, and popliteal arteries in 7%. The mean lesion length was 17.8 ± 11.8 cm. Lesions were categorized as occlusions in 43% (mean occluded length, 16 ± 10 cm). TASC type was A (17%), B (29%), C (38%), and D (15%). Technical success was 99%. Re-stenting was performed in 5% and thrombolysis in 0.6% of patients. Kaplan-Meier estimates for freedom from target lesion revascularization were 90%, 72%, and 62% at 12, 24, and 36 months. Freedom from target vessel revascularization was 88%, 68%, and 59% and freedom from major target limb amputation was 99.6%, 98.9%, and 98.9%, respectively, at 12, 24, and 36 months. Survival was 95%, 89%, and 85% at 12, 24, and 36 months. CONCLUSIONS: This post-market registry-based study shows promising results in treating femoral-popliteal ISR with paclitaxel DCB in comparison to the results of plain balloon angioplasty reported in the literature. These results demonstrate the ability of the SVS VQI to conduct post-market evaluation of peripheral devices in partnership with industry and federal regulators.

Natural history of internal carotid artery stenosis progression.

OBJECTIVE: The aim of this study was to investigate the natural history of internal carotid artery (ICA) stenosis progression. METHODS: This single-institution retrospective cohort study analyzed patients diagnosed with ICA stenosis of 50% or greater on duplex ultrasound from 2015 to 2022. Subjects were drawn from our institutional Intersocietal Accreditation Commission-accredited noninterventional vascular laboratory database. Primary outcomes were incidences of disease progression, and stroke or revascularization after index study. Progression was defined as an increase in stenosis classification category. Imaging, demographic, and clinical data was obtained from our institutional electronic medical record via a database mining query. Cases were analyzed at the patient and artery levels, with severity corresponding to the greatest degree of ICA stenosis on index and follow-up studies. RESULTS: Of 577 arteries in 467 patients, mean cohort age was 73.5 ± 8.9 years at the time of the index study, and 45.0% (n = 210) were female. Patients were followed with duplex ultrasound for a mean of 42.2 ± 22.7 months. Of 577 arteries, 65.5% (n = 378) at the index imaging study had moderate (50%-69%) stenosis, 23.7% (n = 137) had severe (70%-99%) stenosis, and 10.7% (n = 62) were occluded. These three groups had significant differences in age, hypertension, hyperlipidemia prevalence, and proportion on best medical therapy. Of the 467-patient cohort, 56.5% (n = 264) were on best medical therapy, defined as smoking cessation, treatment with an antiplatelet agent, statin, and antihypertensive and glycemic agents as indicated. Mean time to progression for affected arteries was 28.0 ± 20.5 months. Of those arteries with nonocclusive disease at diagnosis, 21.3% (n = 123) progressed in their level of stenosis. Older age, diabetes, and a history of vasculitis were associated with stenosis progression, whereas antiplatelet agent use trended towards decreased progression rates. Of the 467 patients, 5.6% (n = 26) developed symptoms; of those, 38.5% (n = 10) had ischemic strokes, 26.9% (n = 7) had hemispheric transient ischemic attacks, 11.5% (n = 3) had amaurosis fugax, and 23.1% (n = 6) had other symptoms. A history of head and neck cancer was positively associated with symptom development. Of 577 affected arteries, 16.6% (n = 96) underwent intervention; 81% (n = 78) of interventions were for asymptomatic disease and 19% (n = 18) were for symptomatic disease. No patient-level factors were associated with risk of intervention. CONCLUSIONS: A significant number of carotid stenosis patients experience progression of disease. Physicians should consider long-term surveillance on all patients with carotid disease, with increased attention paid to those with risk factors for progression, particularly those with diabetes and a history of vasculitis.

Prior authorization requirements in the office-based laboratory setting are administratively inefficient and threaten timeliness of care.

OBJECTIVE: The objective of this study was to investigate the administrative and clinical impacts of prior authorization (PA) processes in the office-based laboratory (OBL) setting. METHODS: This single-institution, retrospective analysis studied all OBL PAs pursued between January 2018 and March 2022. Case, PA, and coding information was obtained from the practice's scheduling database. RESULTS: Over the study period, 1854 OBL cases were scheduled; 8% (n = 146) required PA. Of these, 75% (n = 110) were for lower extremity arterial interventions, 19% (n = 27) were for deep venous interventions, and 6% (n = 9) were for other interventions. Of 146 PAs, 19% (n = 27) were initially denied but 74.1% (n = 7) of these were overturned on appeal. Deep venous procedures were initially denied, at 43.8% (n = 14), more often than were arterial procedures, at 11.8% (n = 13). Of 146 requested procedures, 4% (n = 6) were delayed due to pending PA determination by a mean 14.2 ± 18.3 working days. An additional 6% (n = 8) of procedures were performed in the interest of time before final determination. Of the seven terminally denied procedures, 57% (n = 4) were performed at cost to the practice based on clinical judgment. CONCLUSIONS: Using PA appeals mechanisms, while administratively onerous, resulted in the overturning of most initial denials.

Renal transplant recipients undergoing endovascular abdominal aortic aneurysm repair have increased risk of perioperative acute kidney injury but no difference in late mortality.

OBJECTIVE: Renal transplant is associated with substantial survival advantage in patients with end-stage renal disease. However, little is known about the outcomes of renal transplant recipients (RTRs) after endovascular abdominal aortic aneurysm repair (EVAR). This study aimed to study the effect of renal transplant on perioperative outcomes and long-term survival after elective infrarenal EVAR. METHODS: The Vascular Quality Initiative database was queried for all patients undergoing elective EVAR from 2003 to 2021. Functioning RTRs were compared with non-renal transplant recipients without a diagnosis of end-stage renal disease (non-RTRs). The outcomes included 30-day mortality, acute kidney injury (AKI), new renal failure requiring renal replacement therapy (RRT), endoleak, aortic-related reintervention, major adverse cardiac events, and 5-year survival. A logistic regression analysis was used to assess the association between RTRs and perioperative outcomes. RESULTS: Of 60,522 patients undergoing elective EVAR, 180 (0.3%) were RTRs. RTRs were younger (median, 71 years vs 74.5 years; P < .001), with higher incidence of hypertension (92% vs 84%; P = .004) and diabetes (29% vs 21%; P = .005). RTRs had higher median preoperative serum creatinine (1.3 mg/dL vs 1.0 mg/dL; P < .001) and lower estimated glomerular filtration rate (51.6 mL/min vs 69.4 mL/min; P < .001). There was no difference in the abdominal aortic aneurysm diameter and incidence of concurrent iliac aneurysms. Procedurally, RTRs were more likely to undergo general anesthesia with lower amount of contrast used (median, 68.6 mL vs 94.8 ml; P < .001) and higher crystalloid infusion (median, 1700 mL vs 1500 mL; P = .039), but no difference was observed in the incidence of open conversion, endoleak, operative time, and blood loss. Postoperatively, RTRs experienced a higher rate of AKI (9.4% vs 2.7%; P < .001), but the need for new RRT was similar (1.1% vs 0.4%; P = .15). There was no difference in the rates of postoperative mortality, aortic-related reintervention, and major adverse cardiac events. After adjustment for potential confounders, RTRs remained associated with increased odds of postoperative AKI (odds ratio, 3.33; 95% confidence interval, 1.93-5.76; P < .001) but had no association with other postoperative complications. A subgroup analysis identified that diabetes (odds ratio, 4.21; 95% confidence interval, 1.17-15.14; P = .02) is associated with increased odds of postoperative AKI among RTRs. At 5 years, the overall survival rates were similar (83.4% vs 80%; log-rank P = .235). CONCLUSIONS: Among patients undergoing elective infrarenal EVAR, RTRs were independently associated with increased odds of postoperative AKI, without increased postoperative renal failure requiring RRT, mortality, endoleak, aortic-related reintervention, or major adverse cardiac events. Furthermore, 5-year survival was similar. As such, while EVAR may confer comparable benefits and technical success perioperatively, RTRs should have aggressive and maximally optimized renal protection to mitigate the risk of postoperative AKI.

Superficial venous procedures can be performed safely and effectively in patients with deep venous reflux.

BACKGROUND: The finding of concurrent deep venous reflux (DVR) when interrogating superficial venous reflux is common and might be a marker of more severe chronic venous insufficiency. However, the safety and clinical and patient-reported outcomes for patients undergoing superficial venous treatment in the presence of DVR remains underreported. Moreover, the factors associated with the persistence and disappearance of DVR after superficial vein treatment have not been evaluated. In the present study, we sought to address these questions. METHODS: We performed a review of the institutional vascular quality initiative database from June 2016 to June 2021. Consecutive patient limbs were identified that had undergone a superficial venous intervention and had duplex ultrasound evaluations available. These patients were divided into those with and without DVR. Those with DVR were further reviewed for anatomic details and the persistence or resolution of DVR after the procedure. The primary outcome was the venous clinical severity score (VCSS) at a follow-up >3 months. The secondary outcomes included the incidence of any postoperative deep vein thrombosis or endovenous heat-induced thrombosis, differences in patient-reported outcomes, rate of resolution of DVR, and factors associated with DVR persistence. Both univariate analysis and multivariate logistic regression were applied. RESULTS: Of the patients who had undergone superficial venous treatment, 644 patient limbs had had DVR and 7812 had not, for a prevalence of 7.6%. The DVR group was associated with a higher burden of chronic venous insufficiency. On univariate analysis, patient limbs, both with and without DVR, had improved significantly in the VCSS at <3 months of follow-up and were not significantly different. At >3 months of follow-up, the VCSS had again improved significantly compared with the VCSS at <3 months of follow-up. However, the difference between the two groups was statistically significant at the longer interval. The magnitude of improvement in the VCSS between the two groups at the longer follow-up were similar statistically (VCSS, 3.17 ± 3.11 vs 3.03 ± 2.93; P = .739). The HASTI (heaviness, achiness, swelling, throbbing, itching) score had similarly improved significantly in both groups but remained significantly higher in the DVR group during follow-up. On multivariate logistic regression, DVR was not associated with an increased VCSS at >3 months of follow-up. No intergroup difference was found in the incidence of postoperative deep vein thrombosis or endovenous heat-induced thrombosis. Of limbs with DVR, 40.8% no longer had evidence of detectable DVR at the latest follow-up venous duplex ultrasound, and DVR limited to a single segment was more likely than DVR in multiple segments to be no longer detectable. CONCLUSIONS: Our results have shown that superficial venous procedures are safe and effective in patients with DVR, leading to improvements in clinical and patient-reported outcomes similar to those for patients without DVR. In a large proportion of the treated limbs, especially those with DVR in a single segment, no evidence of DVR was found after superficial venous intervention. Although patients with DVR will have a higher burden of chronic venous insufficiency, they still appear to derive significant benefit from superficial venous treatment.

The impact of aorto-uni-iliac graft configuration on outcomes of endovascular repair for ruptured abdominal aortic aneurysms.

INTRODUCTION: Endovascular aneurysm repair has improved outcomes for ruptured abdominal aortic aneurysms (rAAA) compared with open repair. We examined the impact of aorto-uni-iliac (AUI) vs standard bifurcated endograft configuration on outcomes in rAAA. METHODS: Patients 18 years or older in the Vascular Quality Initiative database who underwent endovascular aneurysm repair for rAAA from January 2011 to April 2020 were included. Patient characteristics were analyzed by graft configuration: AUI or standard bifurcated. Primary and secondary outcomes included 30-day mortality, postoperative major adverse events (myocardial infarction, stroke, heart failure, mesenteric ischemia, lower extremity embolization, dialysis requirement, reoperation, pneumonia, or reintubation), and 1-year mortality. A subset propensity-score matched cohort was also analyzed. RESULTS: We included 2717 patients: 151 had AUI and 2566 had standard bifurcated repair. There was no significant difference between the groups in terms of age, major medical comorbidities, anatomic aortic neck characteristics, or rates of conversion to open repair. Patients who underwent AUI were more commonly female (30% vs 22%, P = .011) and had a history of congestive heart failure (19% vs 12%, P = .013). Perioperatively, patients who underwent AUI had a significantly higher incidence of cardiac arrest (15% vs 7%, P < .001), greater intraoperative blood loss (1.3 L vs 0.6 L, P < .001), longer operative duration (218 minutes vs 138 minutes, P < .0001), higher incidence of major adverse events (46.3% vs 33.3%, P = .001), and prolonged intensive care unit (7 vs 4.7 days, P = .0006) and overall hospital length of stay (11.4 vs 8.1 days, P = .0003). Kaplan-Meier survival analyses demonstrated significant differences in 30-day (31.1% vs 20.2%, log-rank P = .001) and 1-year mortality (41.7% vs 27.7%, log-rank P = .001). The propensity-score matched cohort demonstrated similar results. CONCLUSIONS: The AUI configuration for rAAA appears to be implemented in a sicker cohort of patients and is associated with worse perioperative and 1-year outcomes compared with a bifurcated graft configuration, which was also seen on propensity-matched analysis. Standard bifurcated graft configuration may be the preferred approach in the management of rAAA unless AUI configuration is mandated by patient anatomy or other extenuating circumstances.

Natural history of renal artery aneurysms.

OBJECTIVE: The existing renal artery aneurysm (RAA) literature is largely composed of reports of patients who underwent intervention. The objective of this study was to review the natural history of RAA. METHODS: This single-institution retrospective analysis studied all patients with RAA diagnosed by computed tomography imaging between 2015 and 2019, identified by our institutional radiology database. Imaging, demographic, and clinical data were obtained via the electronic medical record. He growth rate was calculated for all patients with radiological follow-up. RESULTS: The cohort consists of 331 patients with 338 RAAs. Most patients were female (61.3%), with 11 (3.3%) of childbearing age. The mean age at diagnosis was 71.5 years (range, 24-99 years). Medical comorbidities included hypertension (73.7%), prior smoking (34.4%), and connective tissue disease (3.9%). Imaging indications included abdominal pain (33.5%), unrelated follow-up (29.6%), and follow-up of an RAA initially diagnosed before the study period (10.7%). Right RAA (61.9%) was more common than left (35.1%); 3% of patients had bilateral RAA. The mean diameter at diagnosis was 12.9 ± 5.9 mm. Size distribution included lesions measuring less than <15 mm (69.9%), 15 to 25 mm (27.1%), and more than 25 mm (3.0%). Anatomic locations included the distal RA (26.7%), renal hilum (42.4%), and mid-RA (13.1%). The majority were true aneurysms (98%); of these, 72.3% were fusiform and 27.7% were saccular. Additional characteristics included calcification (82.2%), thrombus (15.9%), and dissection (0.9%). Associated findings included aortic atherosclerosis (65.6%), additional visceral aneurysms (7.3%), and abdominal aortic aneurysm (5.7%). The mean clinical follow-up among 281 patients was 41.0 ± 24.0 months. The mean radiological follow-up among 137 patients was 26.0 ± 21.4 months. Of these, 43 patients (31.4%) experienced growth, with mean growth rate of 0.23 ± 4.7 mm/year; the remainder remained stable in size. Eight patients eventually underwent intervention (5 endovascular), with the most common indications including size criteria (4/8) and symptom development (3/8). No patient developed rupture. On multivariate analysis, obesity (P = .04) was significantly associated with growth. An initial diameter of more than 25 mm was significantly associated with subsequent intervention (P = .006), but was not significantly associated with growth. Four of five RAAs with an initial diameter 30 mm or greater did not undergo intervention. The mean clinical follow-up for these patients was 24 months; none developed rupture and two remained stable in size. CONCLUSIONS: This large institutional cohort found that the majority of RAAs remained stable in size, with few patients meeting indications for repair based on societal guidelines. Current guidelines recommending intervention for asymptomatic aneurysms more than 30 mm seem to be appropriate given their slow progression.

Direct oral anticoagulant agents might be safe for patients undergoing endovenous radiofrequency and laser ablation.

OBJECTIVE: Studies assessing the effect of the use of anticoagulant agents on endovenous thermal ablation (ETA) have been limited to patients taking warfarin. Thus, the aim of the present study was to assess the efficacy and safety of ETA for patients taking direct oral anticoagulants (DOACs). We hypothesized that the outcome of ETA for patients taking DOACs would not be superior to the outcomes for patients taking DOACs. METHODS: We performed a retrospective review to identify patients who had undergone radiofrequency ablation or endovenous laser ablation with 1470-nm diode laser fibers for symptomatic great or small saphenous venous reflux from 2018 to 2020. The patients were dichotomized into those who had received a therapeutic dose of DOACs periprocedurally and those who had not (control group). The outcomes of interest included the rates of treated vein closure at 7 days and 9 months and the incidence of deep vein thrombosis (DVT), endothermal heat-induced thrombosis (EHIT), and bleeding periprocedurally. RESULTS: Of the 301 patients (382 procedures), 69 patients (87 procedures) had received DOACs and 232 control patients (295 procedures) had not received DOACs. The patients receiving DOACs were more often older (mean age, 65 years vs 55 years; P < .001) and male (70% vs 37%; P < .001), with a higher prevalence of venous thromboembolism and more severe CEAP (clinical, etiologic, anatomic, pathophysiologic) classification (5 or 6), than were the control patients. Those receiving DOACs were more likely to have had a history of DVT (44% vs 6%; P < .001), pulmonary embolism (13% vs 0%; P < .001), and phlebitis (32% vs 15%; P < .001). Procedurally, radiofrequency ablation had been used more frequently in the control group (92% vs 84%; P = .029), with longer segments of treated veins (mean, 38 mm vs 35 mm, respectively; P = .028). No major or minor bleeding events nor any EHIT had occurred in either group. Two patients in the control group (0.7%) developed DVT; however, no DVT was observed in those in the DOAC group (P = .441). At 9 months, the treated vein had remained ablated after 94.4% of procedures for patients receiving DOACs and 98.4% of the control group (P = .163). On multivariable analysis, DOAC usage was not associated with an increased risk of vein recanalization (hazard ratio, 5.76; 95% confidence interval, 0.57-58.64; P = .139). An increased preprocedural vein diameter and the use of endovenous laser ablation were associated with an increased risk of recanalization. CONCLUSIONS: In our study of patients who had undergone ETA for symptomatic saphenous venous reflux, the periprocedural use of DOACs did not adversely affect the efficacy of endovenous ablation to ≥9 months. Furthermore, DOAC use did not confer an additional risk of bleeding, DVT, or EHIT periprocedurally. DOACs may be safely continued without affecting the efficacy and durability of ETA.

Comparative analysis of patients undergoing lower extremity bypass using in-situ and reversed great saphenous vein graft techniques.

OBJECTIVE: Autologous great saphenous vein (GSV) is considered the conduit of choice for lower extremity bypass (LEB). However, the optimal configuration remains the source of debate. We compared outcomes of patients undergoing LEB using in-situ and reversed techniques. METHODS: The Vascular Quality Initiative database was queried for patients undergoing LEB with a single-segment GSV in in-situ (ISGSV) and reversed (RGSV) configurations for symptomatic occlusive disease from 2003 to 2021. Patient demographics, procedural detail, and in-hospital and follow-up outcomes were collected. The primary outcome measures included primary patency at discharge or 30 days and one year. Secondary outcomes were secondary patency, and reinterventions at discharge or 30 days and one year. Cox proportional hazards models were created to determine the association between bypass techniques and outcomes of interest. RESULTS: Of 8234 patients undergoing LEBs, in-situ and reversed techniques were used in 3546 and 4688 patients, respectively. The indication for LEBs was similar between the two cohorts. ISGSV was performed more frequently from the common femoral artery and to more distal targets. RGSV bypass was associated with higher intraoperative blood loss and longer operative time. Perioperatively, ISGSV cohort had higher rates of reinterventions (13.2 vs 11.1%; p = 0.004), surgical site infection (4.2 vs 3%; p = 0.003), and lower primary patency (93.5 vs 95%; p = 0.004) but a comparable rate of secondary patency (99 vs 99.1%; p = 0.675). At 1 year, in-situ bypasses had a lower rate of reinterventions (19.4% vs 21.6%; p=0.02), with similar rates of primary (82.6 vs 81.8%; p = 0.237) and secondary patency (88.7 vs 88.9%; p = 0.625). After adjusting for significant baseline differences and potential confounders, in-situ bypass was independently associated with decreased risks of primary patency loss (HR 0.9; 95% CI, 0.82-0.98; p = 0.016) and reinterventions (HR 0.88; 95% CI, 0.8-0.97; p = 0.014) but a similar risk of secondary patency loss (HR 0.99; 95% CI, 0.86-1.16; p = 0.985) at follow-up, compared to reversed bypass. A subgroup analysis of bypasses to crural targets showed that in-situ and reversed bypasses had similar rates of primary patency loss and reinterventions at 1 year. Among patients with chronic limb-threatening ischemia, in-situ bypass was associated with a decreased risk of reinterventions but similar rates of primary and secondary patency and major amputations at 1 year. CONCLUSIONS: In patients undergoing LEBs using the GSV, in-situ configuration was associated with more perioperative reinterventions and lower primary patency rate. However, this was offset by decreased risks of loss of primary patency and reinterventions at 1 year. A thorough intraoperative graft assessment with adjunctive imaging may be performed to detect abnormalities in patients undergoing in-situ bypasses to prevent early failures. Furthermore, closer surveillance of reversed bypass grafts is warranted given the higher rates of reinterventions.

Relationship between iliofemoral venous stenting and femoropopliteal deep venous reflux.

OBJECTIVE: Severe presentations of chronic venous insufficiency can result from reflux or obstruction at the deep venous, perforator, or superficial venous levels. Iliofemoral venous stenting can be used to address central venous obstruction; however, its effects on deep venous reflux (DVR) have remained unclear. The purpose of the present study was to evaluate the effects of iliac vein stenting on femoropopliteal DVR with the hypothesis that ultrasound evidence of DVR would remain absent or would have improved after iliac vein stenting. METHODS: The present study was a retrospective review of patients who had undergone iliofemoral venous stenting from 2013 to 2018. The patients were divided into two cohorts according to the preprocedural presence (group A) or absence (group B) of femoropopliteal DVR. Baseline patient variables were collected, including age, gender, CEAP (clinical, etiologic, anatomic, pathophysiologic) class, presence of concomitant superficial or perforator reflux, deep vein thrombosis history, and additional venous interventions. The primary outcome evaluated was the persistent absence or resolution of DVR on the latest venous duplex ultrasound at follow-up. Other outcomes included the follow-up CEAP classification and the need for secondary deep venous interventions. RESULTS: A total of 275 consecutive patients had undergone iliofemoral venous stenting. Of the 275 patients, 58 had presented with DVR (group A). A comparison of groups A and B revealed that group A had had a greater likelihood of prior deep vein thrombosis (P = .0001) and a higher frequency of superficial venous ablation. The remaining demographic variables did not differ significantly between the two groups. Of the 58 patients in group A, DVR had resolved at follow-up in 17 (P = .0001). When stratified by level, 7 of these 17 patients had had isolated popliteal reflux. In group B, DVR had developed at follow-up in 6 of the 217 patients. The CEAP class had improved from before intervention (C0, 1.1%; C1, 0.4%; C2, 1.8%; C3, 41.4%; C4, 24.9%; C5, 5.9%; C6, 24.5%) to the latest follow up (C0, 4.9%; C1, 1.9%; C2, 5.7%; C3, 34.2%; C4, 22.8%; C5, 17.1%; C6, 13.3%). Significant improvement had occurred in C6 disease within both groups (group A, 16 of 58 [27.6%; P = .0078]; group B, 19 of 217 [8.8%; P = .0203]). CONCLUSIONS: For patients who undergo iliofemoral venous stenting, DVR could improve if present initially and is unlikely to develop if not present before stenting. A cohort of patients had experienced persistent DVR and warranted further evaluation. Prospective studies are required to corroborate the safety, efficacy, and durability of iliofemoral venous stenting for patients with DVR.

Beta-blocker use after thoracic endovascular aortic repair in patients with type B aortic dissection is associated with improved early aortic remodeling.

OBJECTIVE: Beta-blockers (BBs) are first-line anti-impulse therapy for patients presenting with acute type B aortic dissection (TBAD). However, little is understood about their effects after aortic repair. The aim of the present study was to evaluate the role of postoperative BB use on the outcomes of thoracic endovascular aortic repair (TEVAR) in TBAD. METHODS: The Vascular Quality Initiative database was queried for all patients who had undergone TEVAR for TBAD from 2012 to 2020. Aortic-related reintervention, all-cause mortality, and the effects of TEVAR on false lumen thrombosis of the treated aortic segment were assessed and compared between patients treated with and without BBs postoperatively. Cox proportional hazards models were used to estimate the effect of BB therapy on the outcomes. RESULTS: A total of 1114 patients who had undergone TEVAR for TBAD with a mean follow-up of 18 ± 12 months were identified. The mean age was 61.1 ± 11.9 years, and 791 (71%) were men. Of the 1114 patients, 935 (84%) continued BB therapy at discharge and follow-up. The patients taking BBs were more likely to have had an entry tear originating in zones 1 to 2 (22% vs 13%; P = .022). The prevalence of acute, elective, and symptomatic aortic dissection, prevalence of concurrent aneurysms, number of endografts used, distribution of proximal and distal zones of dissection, and operative times were comparable between the two cohorts. At 18 months, significantly more complete false lumen thrombosis (58% vs 47%; log-rank P = .018) was observed for patients taking BBs, and the rates of aortic-related reinterventions (13% vs 9%; log-rank P = .396) and mortality (0.2% vs 0.7%; log-rank P = .401) were similar for patients taking and not taking BBs, respectively. Even after adjusting for clinical and anatomic factors, postoperative BB use was associated with increased complete false lumen thrombosis (hazard ratio, 1.56; 95% confidence interval, 1.10-2.21; P = .012) but did not affect mortality or aortic-related reintervention. A secondary analysis of BB use for those with acute vs chronic TBAD showed a higher rate of complete false lumen thrombosis for patients with chronic TBAD and taking BBs (59% vs 38%; log-rank P = .038). In contrast, no difference was found in the rate of complete false lumen thrombosis for those with acute TBAD between the two cohorts (58% vs 51%; log-rank P = .158). When analyzed separately, postoperative angiotensin-converting enzyme inhibitor use did not affect the rates of complete false lumen thrombosis, mortality, and aortic-related reintervention. CONCLUSIONS: BB use was associated with promotion of complete false lumen thrombosis for patients who had undergone TEVAR for TBAD. In addition to its role in the acute setting, anti-impulse control with BBs appears to confer favorable aortic remodeling and might improve patient outcomes after TEVAR, especially for those with chronic TBAD.

Non-reversed and Reversed Great Saphenous Vein Graft Configurations Offer Comparable Early Outcomes in Patients Undergoing Infrainguinal Bypass.

OBJECTIVE: Data on the efficacy of non-reversed and reversed great saphenous vein bypass (NRGSV and RGSV) techniques are lacking. The aim of the study was to compare the outcomes of patients undergoing open infrainguinal revascularisation using NRGSV and RGSV from a multi-institutional database. METHODS: The Vascular Quality Initiative database was queried for patients undergoing infrainguinal bypasses using NRGSV and RGSV for symptomatic occlusive disease from January 2003 to February 2021. The primary outcome measures included primary and secondary patency at discharge and one year. Secondary outcomes were re-interventions at discharge and one year. Cox proportional hazards models were used to evaluate the impact of graft configuration on outcomes of interest. RESULTS: Of 7 123 patients, 4 662 and 2 461 patients underwent RGSV and NRGSV, respectively. At one year, the rates of primary patency (78% vs. 78%; p = .83), secondary patency (90% vs. 89%; p = .26), and re-intervention (16% vs. 16%; p = .95) were similar between the RGSV and NRGSV cohorts, respectively. Subgroup analysis based on outflow bypass target and indication for revascularisation did not show differences in primary and secondary outcomes between the two groups. Multivariable analysis confirmed that RGSV (NRGSV as the reference) configuration was not independently associated with increased risk of primary patency loss (hazard ratio [HR] 1.01; 95% confidence interval [CI] 0.91 - 1.13; p = .80), secondary patency loss (HR 0.94; 95% CI 0.81 - 1.10; p = .44), and re-intervention (HR 1.03; 95% CI 0.91 - 1.16; p = .67) at follow up. CONCLUSION: The study shows that RGSV and NRGSV grafting techniques have comparable peri-operative and one year primary and secondary patency and re-intervention rates. This effect persisted when stratified by outflow targets and indication for revascularisation. Therefore, optimal selection of vein grafting technique should be guided by the patient's anatomy, vein conduit availability, and surgeon's experience.

Safety and Efficacy of Drug Eluting Stents for Treatment of Transplant Renal Artery Stenosis.

BACKGROUND: Transplant renal artery stenosis (TRAS) after renal transplantation is a common cause of graft dysfunction and failure. Endovascular intervention in the form of percutaneous transluminal angioplasty (PTA) and stenting has rapidly become the dominant treatment modality for the TRAS. There is a paucity of clinical data on the use of drug-eluting stent (DES) for TRAS. We investigated the outcomes of patients with clinically significant TRAS undergoing DES placement. METHODS: A retrospective review of patients with clinically significant TRAS undergoing PTA with DES placement from June 2014 to April 2021 was conducted. Patients treated for TRAS exhibited uncontrolled hypertension and/or unexplained allograft dysfunction. Patient demographics, procedural details, and follow-up outcomes were collected. Primary endpoints were the in-stent primary patency and graft survival. Secondary endpoints were freedom from reintervention, primary-assisted patency, and access-related complications. RESULTS: Thirteen TRAS in 12 patients with graft function alteration were treated with DES. The median age was 57 years (interquartile range (IQR), 48-63 years), and 9 (70%) patients were male. The median follow-up was 9 months (IQR, 4-52 months). The most common comorbidity was hypertension (100%), coronary artery disease (83%), and diabetes. The median time from deceased donor transplant to intervention was 5.8 months (IQR, 3.5-6.7 months). TRAS was most commonly found at the juxta-ostial segment (77%). The procedure was performed with carbon dioxide angiography with minimal amount of iodinated contrast (median, 3 mL) under local anesthesia in 9 (69%), and general anesthesia in 4 (31%) patients. The median stent diameter was 4.5 mm (IQR, 4-5 mm), and the median stent length was 15 mm (IQR, 15-18 mm). No intraoperative complications occurred. The rates of stenosis-free primary patency of the DES and graft survival were 76% and 100%, respectively. All 3 reinterventions for restenosis resulted from the kinking of the transplant renal artery proximal to the DES, which were treated by extending the stent more proximally 1-2 mm into the external iliac artery. There were no access-related complications. The median time to reintervention was 0.9 months (range, 0.23-2 months). Freedom from reintervention and primary-assisted patency were 76% and 100%, respectively. CONCLUSIONS: Our study demonstrates that DES is a safe and effective treatment modality in patients with TRAS at short to mid-term follow-up. As all reinterventions after DES were performed due to kinking of the transplant renal artery proximal to the stent, bridging of the DES 1-2 mm into the external iliac artery is recommended.

Severity of stenosis in symptomatic patients undergoing carotid interventions might influence perioperative neurologic events.

OBJECTIVE: The carotid artery plaque burden, indirectly measured by the degree of stenosis, quantifies a patient's future embolic risk. In natural history studies, patients with moderate degrees of stenosis have had a lower stroke risk than those with severe stenosis. However, patients with symptomatic carotid stenosis who have experienced transient ischemic attack (TIA) or stroke were found to have both moderate and severe degrees of stenosis. We examined the association of carotid artery stenosis severity with the outcomes for symptomatic patients who had undergone carotid intervention, including carotid endarterectomy (CEA), transfemoral carotid artery stenting (TFCAS), and transcervical carotid artery revascularization (TCAR). METHODS: The Society for Vascular Surgery Vascular Quality Initiative database was queried for all patients who had undergone TFCAS, CEA, or TCAR between 2003 and 2020. The patients were stratified into two groups according to stenosis severity-nonsevere (0%-69%) and severe (≥70%). The primary end point was periprocedural neurologic events (stroke and TIA). The secondary end points were periprocedural death, myocardial infarction (MI), and the composite outcomes of stroke/death and stroke/death/MI in accordance with the reporting standards for carotid intervention. RESULTS: Of the 29,614 included symptomatic patients, 5296 (17.9%) had undergone TCAR, 7844 (26.5%) TFCAS, and 16,474 (55.6%) CEA for symptomatic carotid artery stenosis. In the CEA cohort, the neurologic event rate was significantly lower for the patients with severe stenosis than for those with nonsevere stenosis (2.6% vs 3.2%; P = .024). In the TCAR cohort, the periprocedural neurologic even rate was lower for those with severe stenosis than for those with nonsevere stenosis (3% vs 4.3%; P = .033). No similar difference was noted for the TFCAS cohort, with a periprocedural neurologic event rate of 3.8% in the severe group vs 3.5% in the nonsevere group (P = .518). On multivariable analysis, severe stenosis was associated with significantly decreased odds of postprocedural neurologic events after CEA (odds ratio, 0.75; 95% confidence interval, 0.6-0.92; P = .007) and TCAR (odds ratio, 0.83; 95% confidence interval, 0.69-0.99; P = .039) but not after TFCAS. CONCLUSIONS: Severe carotid stenosis, in contrast to more moderate stenosis degrees, was associated with decreased rates of periprocedural stroke and TIA in symptomatic patients undergoing TCAR and CEA but not TFCAS. The finding of increased rates of periprocedural neurologic events in symptomatic patients with lesser degrees of stenosis undergoing TCAR and CEA warrants further evaluation with a particular focus on plaque morphology and brain physiology and their inherent risks with carotid revascularization procedures.

Outcomes of transfemoral carotid artery stenting and transcarotid artery revascularization for restenosis after prior ipsilateral carotid endarterectomy.

OBJECTIVE: Restenosis after carotid endarterectomy (CEA) poses unique therapeutic challenges, with no specific guidelines available on the operative approach. Traditionally, transfemoral carotid artery stenting (TfCAS) has been regarded as the preferred approach to treating restenosis after CEA. Recently, transcarotid artery revascularization with a flow-reversal neuroprotection system (TCAR) has gained popularity as an effective alternative treatment modality for de novo carotid artery stenosis. The aim of the present study was to compare the contemporary perioperative outcomes of TfCAS and TCAR in patients with prior ipsilateral CEA. METHODS: The Vascular Quality Initiative database was reviewed for patients who had undergone TfCAS and TCAR for restenosis after prior ipsilateral CEA between January 2016 and August 2020. The primary outcome was the 30-day composite outcome of stroke and death. The secondary outcomes included 30-day stroke, transient ischemic attack (TIA), myocardial infarction (MI), death, and composite 30-day outcomes of stroke, death, and TIA, stroke and TIA, and stroke, death, and MI. Multivariable logistic regression models were used to evaluate the outcomes of interest after adjustment for potential confounders and baseline differences between cohorts. RESULTS: Of 3508 patients, 1834 and 1674 had undergone TfCAS and TCAR, respectively. The TCAR cohort was older (mean age, 71.6 years vs 70.2 years; P < .001) and less likely to be symptomatic (27% vs 46%; P < .001), with a greater proportion taking aspirin (92% vs 88%; P = .001), a P2Y12 inhibitor (89% vs 80%; P < .001), and a statin (91% vs 87%; P = .002) compared with the TfCAS cohort. Perioperatively, the TCAR cohort had had lower 30-day composite outcomes of stroke/death (1.6% vs 2.7%; P = .025), stroke/death/TIA (1.8% vs 3.3%; P = .004), and stroke/death/MI (2.1% vs 3.2%; P = .048), primarily driven by lower rates of stroke (1.3% vs 2.3%; P = .031) and TIA (0.2% vs 0.7%; P = .031). Among asymptomatic patients, the incidence of stroke (0.6% vs 1.4%; P = .042) and the composite of stroke/TIA (0.8% vs 1.8%; P = .036) was significantly lower after TCAR than TfCAS, and TCAR was associated with a lower incidence of TIA (0% vs 1%; P = .038) among symptomatic patients. On adjusted analysis, the TCAR cohort had lower odds of TIA (adjusted odds ratio, 0.17; 95% confidence interval, 0.04-0.74; P = .019). CONCLUSIONS: Among patients undergoing carotid revascularization for restenosis after prior ipsilateral CEA, TCAR was associated with decreased odds of 30-day TIA compared with TfCAS. However, the two treatment approaches were similarly safe in terms of the remaining perioperative outcomes, including stroke and death and stroke, death, and MI. Our results support the safety and efficacy of TCAR in this subset of patients deemed at high risk of reintervention.