Indications, technical aspects, and outcomes of stent placement in chronic iliofemoral venous obstruction.

BACKGROUND: Iliofemoral venous stent placement (IVS) has evolved to a well-established endovascular treatment modality for chronic iliofemoral venous obstruction (CIVO). Dedicated venous stents gained approval from the US Food and Drug Administration in 2019 and solidified IVS as a defined intervention with clear indications, contraindications, risks, benefits, and procedural management principles. This review focuses on the indications, technical aspects and outcomes of stenting for CIVO. Other aspects pertaining to IVS are covered in other articles that are a part of this series. METHODS: This study conducted a literature search limited to English articles. Three search strategies were used, and references were managed in Covidence software. Four investigators screened and evaluated articles independently, excluding meta-analyses, clinical trial protocols, and nonrelevant studies. Eligible studies, focused on clinical outcomes and stent patencies, underwent thorough review. RESULTS: The literature search yielded 1704 studies, with 147 meeting eligibility criteria after screening and evaluation. Exclusions were based on duplicates, irrelevant content, and noniliac vein stent placement. CONCLUSIONS: Successful IVS for CIVO relies on meticulous patient selection, consistent use of intravascular ultrasound examination during procedures and attention to the technical details of IVS.

A comparison of below-knee vs above-knee endovenous ablation of varicose veins.

OBJECTIVE: Varicose veins have a significant impact on quality of life and can commonly occur in the thigh and calves. However, there has been no large-scale investigation examining the relationship between anatomic distribution and outcomes after varicose vein treatment. This study sought to compare below-the-knee (BTK) and above-the-knee (ATK) varicose vein treatment outcomes. METHODS: Employing the Vascular Quality Initiative Varicose Vein Registry, 13,731 patients undergoing varicose vein ablation for either BTK or ATK lesions were identified. Outcomes were assessed using patient-reported outcomes (PROs) and the Venous Clinical Severity Score (VCSS). Continuous variables were compared using the t-test, and categorical variables were analyzed using the χ2 test. Multivariable logistic regression was used to estimate the odds of improvement after intervention. The multivariable model controlled for age, gender, race, preoperative VCSS composite score, and history of deep vein thrombosis. RESULTS: Patients who received below-knee treatment had a lower preoperative VCSS composite (7.0 ± 3.3 vs 7.7 ± 3.3; P < .001) and lower PROs composite scores (11.1 ± 6.4 vs 13.0 ± 6.6; P < .001) compared with those of patients receiving above-knee treatment. However, on follow-up, patients receiving below-knee intervention had a higher postoperative VCSS composite score (4.4 ± 3.3 vs 3.9 ± 3.5; P < .001) and PROs composite score (6.1 ± 4.4 vs 5.8 ± 4.5; P = .007), the latter approaching statistical significance. Patients receiving above-knee interventions also demonstrated more improvement in both composite VCSS (3.8 ± 4.0 vs 2.9 ± 3.7; P < .001) and PROs (7.1 ± 6.8 vs 4.8 ± 6.6; P < .001). Multivariable logistic regression analysis similarly revealed that patients receiving above-knee treatment had significantly higher odds of improvement in VCSS composite in both the unadjusted (odds ratio [OR], 1.45; 95% confidence interval [CI], 1.28-1.65; P < .001 and adjusted (OR, 1.31; 95% CI, 1.14-1.50; P < .001) models. Patients receiving above-knee treatment also had a significantly higher odds of reporting improvement in PROs composite in both the unadjusted (OR, 1.85; 95% CI, 1.64-2.11; P < .001) and adjusted (OR, 1.65; 95% CI, 1.45-1.88; P < .001) models. CONCLUSIONS: Treatment region has a significant association with PROs and VCSS composite scores after varicose vein interventions. Preoperatively, there were significant differences in the composite scores of VCSS and PROs with patients receiving BTK treatment exhibiting less severe symptoms. Yet, the association appeared to reverse postoperatively, with those receiving BTK treatments exhibiting worse PROs, worse VCSS composites scores, and less improvement in VCSS composite scores. Therefore, BTK interventions pose a unique challenge compared with ATK interventions in ensuring commensurate clinical improvement after treatment.

Neck radiation is not associated with increased risk of perioperative adverse events after transcarotid artery revascularization or transfemoral carotid artery stenting.

OBJECTIVE: It is unclear whether patients with prior neck radiation therapy (RT) are at high risk for carotid artery stenting (CAS). We aimed to delineate 30-day perioperative and 3-year long-term outcomes in patients treated for radiation-induced stenotic lesions by the transfemoral carotid artery stenting (TFCAS) or transcarotid artery revascularization (TCAR) approach to determine comparative risk and to ascertain the optimal intervention in this cohort. METHODS: Data were extracted from the Vascular Quality Initiative CAS registry for patients with prior neck radiation who had undergone either TCAR or TFCAS. The Student t-test and the χ2 test were used to compare baseline patient characteristics. Multivariable logistic regression and Cox Hazard Proportional analysis were used to compare perioperative and long-term differences between patients with and without prior neck radiation following TCAR and TFCAS. Kaplan-Meier estimator was used to determine the incidence of 3-year adverse events. RESULTS: A total of 72,656 patients (TCAR, 40,879; TFCAS, 31,777) were included in the analysis. Of these, 4151 patients had a history of neck radiation. Patients with a history of neck radiation were more likely to be younger, white, and have fewer comorbidities than patients with no neck radiation history. After adjustment for confounding factors, there was no difference in relative risk of 30-day perioperative stroke (P = .11), death (P = .36), or myocardial infarction (MI) (P = .61) between TCAR patients with or without a history of neck radiation. The odds of stroke/death (P = .10) and stroke/death/MI (P = .07) were also not statistically significant. In patients with prior neck radiation, TCAR had lower odds for in-hospital stroke/death/MI (odds ratio, 0.59; 95% confidence interval [CI], 0.35-0.99; P = .05) and access site complications than TFCAS. At year 3, patients with prior neck radiation had an increased hazard for mortality after TCAR (hazard ratio [HR], 1.24; 95% CI, 1.02-1.51; P = .04) and TFCAS (HR, 1.33; 95% CI, 1.12-1.58; P = .001). Patients with prior neck radiation also experienced an increased hazard for reintervention after TCAR (HR, 2.16; 95% CI, 1.45-3.20; P < .001) and TFCAS (HR, 1.67; 95% CI, 1.02-2.73; P<.001). CONCLUSIONS: Patients with prior neck radiation had a similar relative risk of 30-day perioperative adverse events as patients with no neck radiation after adjustment for baseline demographics and disease characteristics. In these patients, TCAR was associated with reduced odds of perioperative stroke/death/MI as compared with TFCAS. However, patients with prior neck radiation were at increased risk for 3-year mortality and reintervention.

Value and limitations of postoperative duplex scans after endovenous thermal ablation.

BACKGROUND: Endovenous thermal ablation (EVTA) of the lower extremity veins has risen to become the main treatment modality for symptomatic venous reflux disease. One of the main reported side effects of EVTA is recanalization. As of today, there is no clear protocol as to when follow-up duplex ultrasound scans should be performed. However, the standard for postoperative duplex after truncal ablation is within 1 week of the procedure. Our aim is to try to find whether there is a particular time period when postoperative duplex ultrasound scans should be performed to allow us to best diagnose recanalization. METHODS: We retrospectively analyzed 9799 procedures in 3237 patients with chronic venous insufficiency owing to great, small, and anterior accessory saphenous vein insufficiency from 2012 to 2018. We excluded 466 perforator veins. All 9799 procedures were performed using EVTA in patients who failed to respond to conservative management initially. Postoperative duplex ultrasound scans were performed within 1 week (3-7 days postoperatively). We defined a successful obliteration as lack of color flow on postoperative scan. We defined symptomatic recanalization as presence of reflux on duplex ultrasound examination in the targeted vessel at follow-up with symptom recurrence. Follow-ups were performed every 3 months in the first year and every 6 months thereafter. RESULTS: Patient ages ranged from 15 to 99 years. The median patient age at the time of the procedures was 63 years (interquartile range [IQR], 51-73 years). The median overall follow-up was 25 months (IQR, 4-56 months). The Clinical, Etiology, Anatomy, and Pathophysiology (CEAP) class of all the procedures were: C1, 21; C2, 208; C3, 3585; C4, 4680; C5, 188; and C6, 1117. There were 145 redo procedures performed after symptomatic recanalization was diagnosed in patients. CEAP class of the redo patients were: C1, 0; C2, 2; C3, 49; C4, 70; C5, 5; and C6, 19. CONCLUSIONS: Most patients underwent a redo procedure performed within the first year after the initial procedure. Conversely, there was great variability as to when redo procedures were performed. Because there is no defined pattern as to when these symptomatic occurrences arise, it may not be required to perform postoperative duplex ultrasound scans after EVTA routinely, but instead when a patient comes back with symptoms such as swelling.

Diabetes, Hypertension, and Smoking Do Not Affect Outcomes of Iliofemoral Vein Stenting for Chronic Proximal Venous Outflow Obstruction.

BACKGROUND: Diabetes, hypertension, and smoking are well-recognized risk factors for peripheral artery disease (PAD), but little is known of their impact on chronic venous insufficiency (CVI). This study evaluates these factors in patients undergoing iliac vein stenting (IVS) for CVI. METHODS: A registry of 708 patients who underwent IVS from August 2011 to June 2021 was retrospectively analyzed. Symptoms were quantified using venous clinical severity score (VCSS) and CEAP classification. Both major and minor reinterventions were recorded. Logistic regression models were used to determine the unadjusted and adjusted odds ratio of any reintervention. Log-rank test was used to assess differences in reintervention-free survival. RESULTS: The prevalence of hypertension was 51.1% (N = 362), diabetes was 23.0% (N = 163), and smoking was 22.2% (N = 157). Patients with diabetes (3.6 vs. 3.4; P = 0.062), hypertension (3.6 vs. 3.3; P < 0.001), and smoking (3.7 vs. 3.4; P = 0.003) had higher CEAP scores than those without these comorbidities. Improvement in VCSS composite scores showed no differences postoperatively (diabetes: P = 0.513; hypertension: P = 0.053; smoking: P = 0.608), at 1-year follow-up (diabetes: P = 0.666; hypertension: P = 0.681; smoking: P = 0.745), or at 5-year follow-up (diabetes: P = 0.525; hypertension: P = 0.953; smoking: P = 0.146). Diabetes (P = 0.454), smoking (P = 0.355), and hypertension (P = 0.727) were not associated with increased odds of major reintervention. Log-rank test similarly showed no differences in reintervention-free survival for major or minor reoperations between those with and without diabetes (P = 0.79), hypertension (P = 0.14), and smoking (P = 0.80). CONCLUSIONS: Diabetes, hypertension, and smoking were prevalent among CVI patients, but unlike in PAD patients, they had little to no impact on long-term outcomes or reinterventions after IVS.

Use of Transcarotid Artery Revascularization, Transfemoral Carotid Artery Stenting, and Carotid Endarterectomy in the US From 2015 to 2019.

Importance: A transcarotid artery revascularization (TCAR) device was approved by the US Food and Drug Administration in 2015 for carotid revascularization in patients at high risk for stroke, cranial nerve injury, or major cardiac event. It is unclear how the introduction of TCAR has changed the use of carotid endarterectomy (CEA) and transfemoral carotid artery stenting (TFCAS). Objective: To quantify the temporal changes in the operative approach to carotid revascularization (CEA vs TFCAS vs TCAR), and to identify patient and disease characteristics commonly associated with each approach. Design, Setting, and Participants: This retrospective cohort study obtained data from the Vascular Quality Initiative database from January 1, 2015, to December 31, 2019. Patients with carotid artery stenosis who underwent CEA, TFCAS, or TCAR were included. Data were analyzed from January to April 2022. Exposures: Month and year of surgery as well as patient risk status. Main Outcomes and Measures: Number and proportion of carotid revascularization procedures by operative approach. Results: A total of 108 676 patients (mean [SD] age 56.6 [12.5] years; 66 684 men [61.4%]) were included in the analysis. The most common operative approach overall was CEA (n = 81 508 [75.0%]), followed by TFCAS (n = 15 578 [14.3%]) and TCAR (n = 11 590 [10.7%]). The number of procedures increased over the study period (16 754 in 2015 vs 27 269 in 2019; P < .001). In 2015, CEA was used in 84.9% of all cases, followed by TFCAS (14.4%) and TCAR (0.8%). In 2019, CEA was used in 64.8% of cases, followed by TCAR (21.9%) and TFCAS (13.3%). The proportional use of CEA decreased by 5.0% (95% CI, -7.4% to -2.6%) per year, and TCAR use increased by 5.3% (95% CI, 2.3%-8.3%) per year. Among patients at high risk, the change was greater: CEA use decreased by 7.8% (95% CI, -11.9% to -3.8%) per year, TFCAS decreased by 4.8% (95% CI, -9.5% to -0.14%) per year, and TCAR increased by 12.6% (95% CI, 7.1%-18.1%) per year. Multinomial logistic regression showed that patient risk status was the most important characteristic associated with TCAR compared with CEA (relative risk ratio, 36.10; 95% CI, 29.24-44.66; P < .001) and TFCAS (relative risk ratio, 14.10; 95% CI, 11.86-16.66; P < .001). Linear regression revealed no association between year of surgery and in-hospital myocardial infarction, stroke, or mortality. Conclusions and Relevance: Results of this study indicate that TCAR has become the dominant carotid revascularization approach, surpassing TFCAS and CEA in patients at high risk for stroke, cranial nerve injury, or cardiovascular events. Patient high-risk status was the main characteristic associated with a stenting approach, highlighting the perceived importance of carotid stenting therapies in this patient population.

The safety of Bruton's tyrosine kinase inhibitors in B-cell malignancies: A systematic review.

B-cell malignancies, most notably lymphomas, make up most of the non-Hodgkin lymphomas in the United States. There are limited randomized data comparing first- and second-generation Bruton tyrosine kinase (BTK) inhibitors. Our aim was to compare the safety profiles of first versus second-generation BTK inhibitors. A systematic search was performed from database inception to January 13, 2020. Studies with BTK inhibitor monotherapy for the treatment of B-cell malignancies in the adult population (>18 years old) were utilized and the adverse events (AEs) were extracted. Fifty-five studies that met the inclusion criteria were included in the systematic review with 41 studies with first generation and 14 studies with second generation. The review included both clinical trials and retrospective studies with average time of follow-up of 2 years for the first-generation group and 18 months for the second-generation group. We found that the incidence of cardiovascular AEs was significantly higher in the first-generation group (20.8%) as compared to the second-generation group (6.3%). However, there was a higher incidence of hematologic/oncologic and gastrointestinal side effects in the second-generation group compared to the first (62.3% compared to 39.2% and 36.9% compared to 28.9%). The number of Grade 5 cardiovascular events (death) was same in the first-generation group compared to the second generation. Further research is needed to develop highly selective BTK inhibitors to avoid unwanted AEs by minimizing off-targets.

Association of carotid revascularization approach with perioperative outcomes based on symptom status and degree of stenosis among octogenarians.

OBJECTIVE: Age ≥80 years is known to be an independent risk factor for periprocedural stroke after transfemoral carotid artery stenting (TF-CAS) but not after carotid endarterectomy (CEA). The objective of the present study was to compare the perioperative outcomes for CEA, TF-CAS, and transcarotid artery revascularization (TCAR) among octogenarian patients (aged ≥80 years) overall and stratified by symptom status and degree of stenosis. METHODS: All patients aged ≥80 years with 50% to 99% carotid artery stenosis who had undergone CEA, TF-CAS, or TCAR in the Vascular Quality Initiative (2005-2020) were included. We compared the perioperative (30-day) incidence of ipsilateral stroke or death for CEA vs TF-CAS vs TCAR using analysis of variance and multivariable logistic regression models. The results were confirmed in a sensitivity analysis stratified by symptom status and degree of stenosis. RESULTS: Overall, 28,571 carotid revascularization procedures were performed in patients aged ≥80 years: CEA, n = 20,912 (73.2%), TF-CAS, n = 3628 (12.7%), and TCAR, n = 4031 (14.1%). The median age was 83 years (interquartile range, 81.0-86.0 years); 49.8% of the patients were symptomatic (51.9% CEA, 46.2% TF-CAS, 42.4% TCAR); and 60.7% had high-grade stenosis (59.0% CEA, 65.2% TF-CAS, 65.4% TCAR). Perioperative stroke/death occurred most frequently following TF-CAS (6.6%), followed by TCAR (3.1%) and CEA (2.5%; P < .001). After adjusting for baseline differences between groups, the odds ratio (OR) for stroke/death was greater for TF-CAS vs CEA (adjusted OR [aOR], 3.35; 95% confidence interval [CI], 2.65-4.23), followed by TCAR vs CEA (aOR 1.49, 95% CI 1.18-1.87). The risk of perioperative stroke/death remained significantly greater for TF-CAS compared with CEA regardless of symptom status and degree of stenosis (P < .05 for all). In contrast, the risk of stroke/death was higher for TCAR vs CEA for asymptomatic patients (aOR, 2.04; 95% CI, 1.41-2.94) and those with high-grade stenosis (aOR, 1.49; 95% CI, 1.11-2.05) but similar for patients with symptomatic and moderate-grade disease (P > .05 for both). The risk of myocardial infarction was lower with TCAR (aOR, 0.59; 95% CI, 0.40-0.87) and TF-CAS (aOR, 0.56; 95% CI, 0.40-0.87) compared with CEA overall. CONCLUSIONS: Overall, TCAR and CEA can be safely offered to older adults, in particular, symptomatic patients and those with moderate-grade stenosis. TF-CAS should be avoided in older patients when possible.

Correlation of body mass index with recanalization risk after endovenous thermal ablation.

OBJECTIVE: Chronic venous insufficiency (CVI) has an increased prevalence among obese individuals with body mass indices (BMI) over 30. A safe, efficacious, and evidence-based recommended treatment for CVI due to superficial venous reflux (SVR) in great saphenous veins (GSVs), small saphenous veins (SSVs), accessory saphenous veins (ASVs), and reflux in the perforator veins (PVs) is endovenous thermal ablation (EVTA). We sought to identify if BMI is an independent risk factor for recanalization after EVTA. METHODS: All patients with CVI were initially managed conservatively, and those with pathologic SVR refractory to compression therapy were offered EVTAs depending on the site of reflux. Sonographic confirmation of SVR was defined as >500 milliseconds of reflux in the GSVs, SSVs, and ASVs and a diameter >4 mm. PV reflux was confirmed as >350 milliseconds of reflux and a diameter >2.5 mm. All patients received a follow-up duplex ultrasound 1 week after the procedure, every 3 months for the first year, and every 6 months thereafter. Multivariate analysis with logistic regression was performed regarding patients' age, ablation modality (laser vs radiofrequency ablation), vein location and laterality, BMI, and recanalization. RESULTS: From 2013 to 2018, 9739 endovenous ablations were performed on 3070 patients. Endovenous laser was used in 3862 procedures and radiofrequency ablation in 5831 procedures. Veins treated with EVTA were distributed as follows: 6182 GSVs, 2509 SSVs, 597 ASVs, and 451 PVs. The mean patient age was 61.1 years (15-99, standard deviation [SD] ±15.6) with a mean BMI of 31.2 kg/m2 (13.7-69.5, SD ±7.3). A total of 68.4% patients were women and 31.4% men. The mean follow-up was 25.8 months (0-65.9, SD ±12.9). Multivariate statistical analysis with logistic regression was used to determine potential statistical significance between BMI and vein recanalization after EVTA. Overall, obese patients experienced more recanalizations than nonobese patients (P = .032), with an average BMI of 33 kg/m2 for recanalizations. PVs were statistically more likely to recanalize than any other vein (P = .0001). A secondary analysis was performed with the exclusion of PVs, due to their five times increased risk of recanalization, and showed no significant difference of recanalization across all BMI subgroups (P = .127). CONCLUSIONS: BMI does not predict recanalization risk after EVTA, except for ablations performed on PVs.

Partial In-Stent Thrombosis After Iliac Vein Stenting in Non-Thrombotic Vein Lesions.

OBJECTIVE: Iliac vein stenting is a safe and efficacious procedure for the correction of iliac vein stenosis. One of its known major complications is complete iliac vein stent thrombosis. However, we have noticed in our practice that a number of patients developed only early partial in-stent (<60%) thrombosis, within the first 30 days. In order to try to learn more about these lesions, we reviewed the data for possible causes of these lesions. MATERIALS/METHODS: From September 2012 to August 2018, we obtained 3518 iliac vein venograms using intravascular ultrasound (IVUS) for patients with venous insufficiency who failed to respond to conservative therapy. Patients were followed up with transcutaneous duplex ultrasound (DUS) every 3 months for the first year and every 6 - 12 months thereafter. Patients were prescribed clopidogrel for 3 months or were told to continue their pre-existing anticoagulants. RESULTS: There were 2234 women and 1284 men who received an iliac vein stent. The mean age was 65.7 ±14 years. Mean follow-up for this cohort was 17 months. Of 74 patients developed a full thrombosis, 38 developed a partial venous thrombosis and 3406 developed no thrombosis. When comparing those who developed a partial thrombus versus those who developed no thrombus/full thrombus, overall age, laterality, CEAP, gender, and whether the patient received clopidogrel prior to the procedure and after the procedure were not found to be statistically significant factors. However, patients with an ASA score of 2 or 3,were found to be at a higher risk of developing a partial thrombus(P = 0.0223) compared to those who had an ASA score of 1 or 4. CEAP Scores and ASA class breakdown can be seen in Table 1 and Table 2, respectively. Of the 38 partial venous thrombosis that developed,18 completely resolved within the first 3 months after the procedure and 20 remained chronic past 3 months after the procedure. Patients with partial venous thrombosis were asymptomatic upon clinical presentation, and none developed post thrombotic syndrome (PTS) or pulmonary embolism (PE). Male gender was associated with partial thrombus resolution(P = 0.0036) CONCLUSIONS: Patients with ASA scores of 2 or 3, seemed to be at a higher risk of developing a partial thrombus when compared to patients with ASA score of 1 or 4. Male gender was associated with partial thrombus resolution. All other factors appear to not be statistically significant in impacting the development of a partial thrombus. This has been the first attempt to look at this new clinical entity.

Success rate and factors predictive of redo endothermal ablation of small saphenous veins.

OBJECTIVE: Endothermal ablation, such as endovenous laser ablation (EVLA) and radiofrequency ablation (RFA), has been increasingly used for treatment of small saphenous vein (SSV) insufficiency. Prior studies have shown recurrence rates of 0% to 10% in incompetent SSVs (ISSVs). The objective of the present study was to determine the efficacy of redo venous ablation for symptomatic recanalized SSVs and to predict the factors related to recanalization. METHODS: A retrospective analysis of 2566 procedures in 1752 patients with chronic venous insufficiency due to ISSVs from 2012 to 2018 was performed, using individual medical record review for data extraction. All 2566 procedures were performed using endothermal ablation for patients in whom initial conservative management had failed. Postoperative duplex ultrasound scans were performed within 3 to 7 days after treatment. We defined successful obliteration as a lack of color flow using postoperative duplex ultrasound. We defined recanalization as the presence of reflux on duplex ultrasound in the target vessel during follow-up. We conducted follow-up examinations every 3 months during the first year and every 6 months subsequently. RESULTS: Of the 2566 procedures, redo ablation was performed in 91 ISSVs for 86 patients, including 58 women and 28 men. Of the 91 procedures, 54 were performed on the left lower extremity and 37 on the right lower extremity. The mean body mass index was 32.2 ± 7.66 kg/m2. The mean age was 62.4 ± 15.10 years. The CEAP (Clinical, Etiology, Anatomy, and Pathophysiology) class was C1, C2, C3, C4, C5, and C6 for 0, 0, 29, 43, 1, and 18 patients, respectively. The mean maximum diameter of the targeted veins for the redo procedures was 4.51 ± 1.33 mm. Of the 91 procedures, 40 were performed using EVLA and 51 were performed using RFA. The initial technical success was 98.9%. The redo procedures showed an early closure of 96.7%. At a mean follow-up duration of 24.9 ± 14.9 months, the closure rate was 96.5%. No correlation was found between successful obliteration with the redo procedure and age, gender, CEAP class, laterality, EVLA vs RFA, body mass index, or vein diameter. CONCLUSIONS: The rates of successful closure for ISSVs with initial and redo procedures were comparable. These data have validated the potential usefulness of performing redo SSV ablation.

Relationship between blood type and outcomes following COVID-19 infection.

Since the onset of the COVID-19 pandemic, a concentrated research effort has been undertaken to elucidate risk factors underlying viral infection, severe illness, and death. Recent studies have investigated the association between blood type and COVID-19 infection. This article aims to comprehensively review current literature and better understand the impact of blood type on viral susceptibility and outcomes.

Physician impact on use of fluoroscopy during endovascular procedures to improve radiation safety.

OBJECTIVE: To determine whether differences exist in fluoroscopy time and radiation exposure during lower extremity endovascular procedures performed by fellowship trained vascular surgeons vs general surgeons, to minimize radiation exposure to operating room staff. METHODS: A retrospective review of all lower extremity endovascular procedures was performed from August 1, 2014, to January 29, 2016. The procedures were performed by the surgical department's four surgeons with endovascular privileges: two vascular surgeons and two general surgeons. Only procedures involving lower extremity arterial angiograms with balloon angioplasty, stenting, or atherectomy were included. The operative records were reviewed for each case. The total fluoroscopy time and total radiation dose for each procedure were recorded. Procedures were grouped according to the number of endovascular interventions as one to two interventions, three to four interventions, and five or more interventions performed. Statistical analysis was performed with a P value of less than .05 considered significant. RESULTS: About 271 lower extremity endovascular procedures were performed during the study period by 4 surgeons. The average age of the patient population was 70 years. The total number of procedures performed over the study period were 112, 45, 91, and 25 for surgeons 1 through 4, respectively. On average, 3.24 interventions were performed during each procedure. Vascular surgeons were found to have shorter fluoroscopy time for procedures involving one to two (7.8 vs 30.1; P < .01), three to four (9.3 vs 34.2; P < .01), and five or more (11.5 vs 51.9; P < .01) interventions. Vascular surgeons were also found to have less radiation exposure compared with general surgeons in procedures with one to two (1.69 vs 3.53; P = .001) and five or more (2.3 vs 5.4; P = .003) interventions. There was no significant difference in radiation exposure between vascular and general surgeons for procedures with three to four interventions (5.86 vs 5.59; P = .95). CONCLUSIONS: In this small series at our institution, lower extremity endovascular procedures performed by specialty trained vascular surgeons were associated with both decreased operative fluoroscopy time and decreased radiation exposure when compared with general surgeons.

Effect of Pre-Procedure Clopidogrel With Iliac Vein Stenting in Non-Thrombotic Vein Lesions.

OBJECTIVES: Iliac vein stenting is a relatively new procedure in the treatment of chronic venous insufficiency. Research has shown that it is a safe and effective form of treatment, however, one of the well-known risks is in-stent thrombosis. We hypothesize that a single 75 mg dose of Clopidogrel the night prior to the procedures along with a 3-month regimen post-op would decrease the 30-day thrombosis rate. METHODS: A retrospective study was performed on 3,518 patients from September 2012 to August 2018 who received an iliofemoral stent. Patients were broken down into 2 main groups: those given Clopidogrel post-stent and those given Clopidogrel both pre- and post-stent. In our practice, we prescribe a 3-month course of Clopidogrel after iliac vein stenting. Patients were also checked for any anticoagulant medications pre- and/or post-stent. The 30-day thrombosis rates were recorded for each patient. RESULTS: 1,205 patients received Clopidogrel pre-procedurally and post-procedurally, 1,941 patients received Clopidogrel only post-procedurally. 372 patients were excluded from the study because they were on other anti-coagulant medications. Mean follow-up for this cohort was 17 months. 112 total patients developed some degree of 30 day in-stent thrombosis (3.6%). 74 patients developed a complete thrombosis of the stent and 38 developed a partial (≤60% occlusion) thrombosis. Of the 1,205 patients who were on clopidogrel pre-stenting, 28 had a complete thrombosis and 10 had a partial in-stent thrombosis. Of the 1,941 patients on Clopidogrel only post-stenting, 46 had a complete thrombosis and 28 had a partial in-stent thrombosis. Using the Chi-squared test, there were no statistically significant differences between the group of patients receiving Clopidogrel pre- and post-stent vs. just post-stent with respect to 30-day any degree of thrombosis rates (complete and partial thrombosis) (p = .33). Using the Chi-squared test, there were no statistically significant differences between the group of patients receiving Clopidogrel pre- and post-stent vs. just post-stent with respect to 30-day complete thrombosis rates (p = .93). CONCLUSIONS: There appears to be no statistical difference in 30-day thrombosis rates between those receiving Clopidogrel the night prior vs. those who do not receive Clopidogrel the night prior. Therefore, we conclude that it is not necessary to give this single dose the night prior to iliac vein stenting procedures.

Prinzmetal-Like Acute Limb Ischemia.

Vasospasm-induced acute limb ischemia (ALI), also known as vasospastic limb ischemia (VLI), is a rare, underreported vascular event. Unlike thrombotic and embolic occlusive etiologies, which often warrant revascularization, vasospasm is a transient phenomenon that may be successfully managed conservatively without surgical intervention. Thus, prompt recognition and accurate diagnosis of VLI is imperative to avoid unnecessary surgical or endovascular procedures. This diagnosis, however, can pose as a challenge for clinicians, as it can present with clinical signs and symptoms near-identical to the presentation of thrombotic-induced ALI. In this report, we present a patient that experienced 2 vasospasm-induced ischemic events; the patient developed Rutherford IIb acute limb-threatening ischemia following cardiac catheterization for myocardial infarction. Computer tomography angiography findings of her right leg revealed acute occlusion suggesting the need for immediate operative intervention for limb salvage. However, due to her critical state, she instead was managed with medical treatments. Despite no intervention, the patient had full resolution of her right leg symptoms. We present this case to highlight the unusual multifocality of vasospastic events and to increase awareness of the diagnostic challenges associated with VLI.

Early vascular surgery response to the COVID-19 pandemic: Results of a nationwide survey.

OBJECTIVE: The COVID-19 pandemic has had major implications for the United States health care system. This survey study sought to identify practice changes, to understand current personal protective equipment (PPE) use, and to determine how caring for patients with COVID-19 differs for vascular surgeons practicing in states with high COVID-19 case numbers vs in states with low case numbers. METHODS: A 14-question online survey regarding the effect of the COVID-19 pandemic on vascular surgeons' current practice was sent to 365 vascular surgeons across the country through REDCap from April 14 to April 21, 2020, with responses closed on April 23, 2020. The survey response was analyzed with descriptive statistics. Further analyses were performed to evaluate whether responses from states with the highest number of COVID-19 cases (New York, New Jersey, Massachusetts, Pennsylvania, and California) differed from those with lower case numbers (all other states). RESULTS: A total of 121 vascular surgeons responded (30.6%) to the survey. All high-volume states were represented. The majority of vascular surgeons are reusing PPE. The majority of respondents worked in an academic setting (81.5%) and were performing only urgent and emergent cases (80.5%) during preparation for the surge. This did not differ between states with high and low COVID-19 case volumes (P = .285). States with high case volume were less likely to perform a lower extremity intervention for critical limb ischemia (60.8% vs 77.5%; P = .046), but otherwise case types did not differ. Most attending vascular surgeons worked with residents (90.8%) and limited their exposure to procedures on suspected or confirmed COVID-19 cases (56.0%). Thirty-eight percent of attending vascular surgeons have been redeployed within the hospital to a vascular access service or other service outside of vascular surgery. This was more frequent in states with high case volume compared with low case volume (P = .039). The majority of vascular surgeons are reusing PPE (71.4%) and N95 masks (86.4%), and 21% of vascular surgeons think that they do not have adequate PPE to perform their clinical duties. CONCLUSIONS: The initial response to the COVID-19 pandemic has resulted in reduced elective cases, with primarily only urgent and emergent cases being performed. A minority of vascular surgeons have been redeployed outside of their specialty; however, this is more common among states with high case numbers. Adequate PPE remains an issue for almost a quarter of vascular surgeons who responded to this survey.

Fast-track thrombolysis protocol for acute limb ischemia.

OBJECTIVE: Catheter-directed thrombolysis in the treatment of acute lower extremity arterial occlusions often requires several interventional sessions to generate successful outcomes. It is typically an expensive procedure, necessitating extended hospital length of stay (LOS) that may be associated with an increase in both local and systemic hemorrhagic complications. Five years ago, we created the fast-track thrombolysis protocol for arteries (FTTP-A) to deal with these concerns. The goal of our protocol is to re-establish patency during the first session of thrombolysis, thus decreasing costs and complications associated with prolonged periods of thrombolytic exposure. METHODS: A retrospective study of 42 patients who were treated for acute limb ischemia at our institution by FTTP-A from January 2014 to February 2019 was performed. FTTP-A includes periadventitial lidocaine injection at the arterial puncture site under ultrasound guidance, contrast arteriography of the entire targeted segment, pharmacomechanical rheolytic thrombectomy of the occluded arterial segment, tissue plasminogen activator infusion along the occluded segment, balloon maceration of the thrombus, and (if deemed necessary) placement of a stent in an area of significant (≥30%) stenosis that is refractory to balloon angioplasty and thrombolysis. After the stenosis or thrombus is cleared, patients are prescribed an oral anticoagulant agent. RESULTS: Primary FTTP-A (50 total interventions) was performed in 42 patients. The median age of patients was 67.2 ± 12.2 years (range, 41-98 years), and 54.8% were male; 59.5% of the procedures were performed on the left lower extremity. Initial arterial access was obtained through the common femoral artery in 39 of 42 cases (92.9%); in the remaining 3 cases, it was obtained in a left bypass access site, a right femoral-popliteal graft, and a right femoral-femoral graft. The mean operative time was 148.9 ± 62.9 minutes (range, 83-313 minutes), and the mean volume of tissue plasminogen activator infused was 9.7 ± 4.0 mg (range, 2-20 mg). The median cost including medications and interventional tools was $4673.19 per procedure. The mean postoperative LOS was 3.1 ± 4.5 days (range, 1-25 days). Median postoperative LOS was 1 day. Mean postoperative follow-up was 27 ± 19.2 months (range, 0-62 months). Single-session FTTP-A was successful in 81% (n = 34/42) of patients; the remaining 8 patients (19%) required a single additional session. Of the 42 patients, 34 (81%) required arterial stenting. Periprocedural complications consisted of one patient with hematuria, which resolved, and one patient with thrombocytopenia, which resolved. No patients experienced rethrombosis within 30 days of FTTP-A. During the 5-year study period, there was no significant local or systemic hemorrhage, limb loss, or mortality related to this protocol. CONCLUSIONS: FTTP-A appears to be a safe, efficacious, and cost-effective procedure in the resolution of acute lower extremity arterial occlusions.

Dyeless iliac vein stenting.

OBJECTIVE: Iliac vein stenting is increasingly being explored for the treatment of chronic venous insufficiency. While venography is considered the gold standard for assessing iliac veins, some have proposed that intravascular ultrasound should be utilized instead due to its greater sensitivity at detecting stenotic lesions. Routinely, our service uses both intravascular ultrasound and venography, but we have noted that some patients cannot tolerate dye due to allergy, renal insufficiency, or deemed high-risk by the interventionalist due to uncontrolled medical co-morbidities. This study aimed to investigate whether forgoing dye had an impact on iliac vein stent thrombosis. METHODS: From 2012 to 2016, 1482 iliac vein procedures (91 intravascular ultrasound-only and 1391 intravascular ultrasound plus venography) were performed on 992 patients who failed conservative treatment for chronic venous insufficiency. Our mean patient age was 65.8 years (range 21-99; SD ± 14.3) with 347 male and 645 female patients. The clinical presenting symptoms per clinical-etiology-anatomy-pathophysiology classification for the intravascular ultrasound-only cohort were C1:0, C2:3, C3:31, C433, C5:5, C6:20 and for the intravascular ultrasound plus venography cohort were C1:0, C2:24, C3:566, C4:583, C5:30, C6:188. Stent thrombi that developed within or at 30 days of stenting were categorized as early and greater than 30 days as late. Transcutaneous duplex ultrasound classified stent thrombi as either partial or occlusive. Our average follow-up time was 19.4 months (0-42, SD ± 12.5). RESULTS: A total of 2.2% intravascular ultrasound-only patients versus 2.75% intravascular ultrasound plus venogram patients developed early stent thrombosis, p = 0.35. Early partial stent thrombosis occurred in 1.1% of the intravascular ultrasound-only group versus 2.6% of the intravascular ultrasound plus venogram group, p = 0.38. Early occlusive stent thromboses occurred in 1.1% of intravascular ultrasound-only patients and 0.15% of intravascular ultrasound plus venogram patients, p = 0.06. Late stent thromboses developed in 4% of patients in the intravascular ultrasound-only cohort and 4% in the intravascular ultrasound plus venogram cohort, p = 0.97. Late partial stent thromboses occurred in 2.7% of intravascular ultrasound-only patients versus 2.6% in intravascular ultrasound plus venogram patients, p = 0.99. Late occlusive stent thromboses occurred in 1.3% of intravascular ultrasound-only patients versus 1.4% of intravascular ultrasound plus venogram patients, p = 0.95. Moreover, the formation of any stent was 6.2% in the intravascular ultrasound-only versus 6.75% in the intravascular ultrasound plus venogram group, p = 0.55. CONCLUSION: Results of our study show no significant difference in stent thrombosis between the intravascular ultrasound-only and intravascular ultrasound plus venogram cohorts. This concludes that using intravascular ultrasound alone is safe for iliac vein stenting.

Safety of vascular interventions performed in an office-based laboratory in patients with low/moderate procedural risk.

OBJECTIVE: An exponential increase in number of office-based laboratories (OBLs) has occurred in the United States, since the Center for Medicare and Medicaid Services increased reimbursement for outpatient vascular interventions in 2008. This dramatic shift to office-based procedures directed to the objective to assess safety of vascular procedures in OBLs. METHODS: A retrospective analysis was performed to include all procedures performed over a 4-year period at an accredited OBL. The procedures were categorized into groups for analysis; group I, venous procedures; group II, arterial; group III, arteriovenous; and group IV, inferior vena cava filter placement procedures. Local anesthesia, analgesics, and conscious sedation were used in all interventions, individualized to the patient and procedure performed. Arterial closures devices were used in all arterial interventions. Patient selection for procedure at OBL was highly selective to include only patients with low/moderate procedural risk. RESULTS: Nearly 6201 procedures were performed in 2779 patients from 2011 to 2015. The mean age of the study population was 66.5 ± 13.31 years. There were 1852 females (67%) and 928 males (33%). In group I, 5783 venous procedures were performed (3491 vein ablation, 2292 iliac vein stenting); with group II, 238 arterial procedures (125 femoral/popliteal, 71 infrapopliteal, iliac 42); group III, 129 arteriovenous accesses; and group IV, 51 inferior vena cava filter placements. The majority of procedures belonged to American Society of Anesthesiology class II with venous (61%) and arterial (74%) disease. A total of 5% patients were deemed American Society of Anesthesiology class IV (all on hemodialysis). There was no OBL mortality, major bleed, acute limb ischemia, myocardial infarction, stroke, or hospital transfer within 72 hours. Minor complications occurred in 14 patients (0.5%). Thirty-day mortality, unrelated to the procedure, was noted in 9 patients (0.32%). No statistically significant differences were noted in outcomes between the four groups. CONCLUSIONS: Our data suggest that it is safe to use OBL for minimally invasive, noncomplex vascular interventions in patients with a low to moderate cardiovascular procedural risk.

Resolution times of endovenous heat-induced thrombosis.

OBJECTIVE: Lower extremity endovenous ablation has become the primary treatment modality for symptomatic venous reflux disease. Endovenous heat-induced thrombosis (EHIT) has been reported as one of the primary complications of these venous ablative procedures. Our aim was to determine how long EHITs take to resolve and the factors affecting this length of time. METHODS: A retrospective analysis was performed of 10,029 consecutive procedures from March 2012 to September 2018 performed on 3218 patients who underwent endovenous ablation for lower extremity venous reflux. There were 6091 procedures performed with radiofrequency ablation (RFA) and 3938 with endovenous laser ablation (EVLA). Postprocedural venous duplex ultrasound was performed to evaluate for EHIT and recanalization at 3 to 7 days, every 3 months for the first year, and every 6 to 12 months thereafter. JMP version 14 (SAS Institute, Cary, NC) was used for all statistical analysis. RESULTS: EHIT was found to have developed in 186 patients; 109 patients had been treated with RFA and 77 with EVLA. The average age of the patients receiving EVLA in whom EHIT developed was 59.97 ± 11.61 years. The patients who received RFA and in whom EHIT developed had an average age of 73.4 ± 9.64 years. The average time of resolution for the EVLA group was 75 ± 71.97 days. The average resolution time for the RFA group was 139.8 ± 232.52 days. There were no statistical differences between EHIT resolution times and age, sex, body mass index, clinical class, laterality, type of vein treated, or whether the patient was taking clopidogrel preoperatively or postoperatively. A statistical difference was found between EHIT resolution time and whether the patient was treated with EVLA or RFA (P = .0332). CONCLUSIONS: Our study seems to suggest that EHIT resolution times may be related to the difference in treatment modality between EVLA and RFA. The data suggest that EHIT resolves more quickly with the use of EVLA than with RFA.