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Safety of Iliac Vein Stenting in the Office-Based Laboratory: Experience with 4,312 Nonthrombotic Iliac Vein Lesions
Srivastava, Sundeep; Ascher, Enrico; Hingorani, Anil
OBJECTIVE:The study aims to evaluate the incidence of thirty-day thrombosis following iliac vein stent placement, stratified by age, and to analyze long-term follow-up outcomes. METHODS:A retrospective analysis was conducted of 4,312 procedures performed in 2,642 patients with symptomatic chronic venous insufficiency (CEAP clinical classes 3-6) from 2012 to 2024. Patients underwent iliac vein assessment using intravascular ultrasound (IVUS) and received stent placement. Follow-up included iliac vein duplex ultrasound assessments at 3 to 7 days postoperatively, with additional evaluations at 3 to 6 months during the first year. For subsequent years, follow-up occurred at 6 to 12-month intervals. Intraoperative heparin was not administered, and postoperative management included daily clopidogrel (Plavix). Stents were assessed for partial and complete thrombosis. RESULTS:The mean age of the study population was 73 years (range, 30-108), with 39.30% male and 60.70% female patients. Age distribution by decade, based on the number of nonthrombotic iliac vein lesions (NIVLs) treated, was as follows: patients in their 30s (43), 40s (151), 50s (498), 60s (926), 70s (1,116), 80s (1,035), and >90 years (543). Thirty-day thrombosis rates by age group were: 30s (0%), 40s (0.01324%), 50s (0.0200%), 60s (0.0118%), 70s (0.0179%), 80s (0.0116%), and >90s (0.0074%). Thirty-day thrombosis rates by CEAP clinical class were: CEAP 3 (0.01395%), CEAP 4 (0.0121%), CEAP 5 (0.0172%), and CEAP 6 (0.0166%). Among patients with thrombosis within 30 days of stent placement, 76.3% experienced partial stent thrombosis and 27.7% experienced complete stent thrombosis. The mean age of patients with complete thrombosis was 71.4 ± 17 years, compared with 71.8 ± 12 years for those with partial thrombosis. Of patients with complete thrombosis, 71.43% were female. Of the 14 patients with complete thrombosis within 30 days, 10 cases occurred between 2012 and 2021, three in 2022, and one in 2023. Binary logistic regression revealed no significant association between thirty-day thrombosis and age (p = 0.719), CEAP clinical class (p = 0.938), or laterality (p = 0.326). CONCLUSIONS:Iliac vein stenting for symptomatic nonthrombotic iliac vein lesions (NIVL) is a safe and effective procedure with a low incidence of early thrombosis. Age, laterality, and CEAP clinical class were not significantly associated with 30-day thrombosis outcomes. This study supports the use of iliac vein stenting in patients across a broad spectrum of CVI severity, demonstrating its effectiveness in an outpatient-based laboratory (OBL) setting.
PMID: 42542208
ISSN: 2213-3348
CID: 6070500
Race/Ethnicity and Outcomes of Venous Ablation Procedures
Kibrik, Pavel; Kwon, Jenna; Singh, Nikita; Khan, Hason; Ali, Ali Basil; Santos, Tyler; Arustamyan, Michael; Shugol, Leana; Ascher, A Natalie; Ascher, Enrico; Hingorani, Anil
OBJECTIVE:To evaluate the effectiveness and safety of endovenous ablation across racial and ethnic groups by comparing rates of endovenous heat-induced thrombosis (EHIT) and recanalization. METHODS:We retrospectively analyzed 13,335 endothermal ablation procedures (radiofrequency or laser) performed from 2012 to 2022 at a single outpatient center. Patient demographics, including self-identified race/ethnicity (Asian, Black, Hispanic, White), were recorded. Post-procedural duplex ultrasound was conducted at 3-7 days, 3-6 months, and then every 6-12 months. EHIT (classes 1-4) and recanalization of the treated vein were identified on follow-up imaging. Outcomes were compared across racial/ethnic groups using univariable and multivariable logistic regression. RESULTS:Among 13,335 ablations (8,187 radiofrequency and 5,148 laser) in 3,218 patients, 67.1% were performed in women. Mean follow-up was 25.8 ± 12.9 months (range, 3-72 months). EHIT incidence was highest in Black patients (3.0%), followed by Asian (2.6%), White (1.7%), and Hispanic (1.4%) patients; the difference between Black and White patients was significant (p < 0.001), while other pairwise comparisons were not. Procedural success (no EHIT or recanalization) was high and comparable across groups: 96.1% in Asians, 95.2% in Blacks, 96.1% in Hispanics, and 96.2% in Whites. On multivariable analysis, Black race was associated with higher EHIT risk (OR = 1.92, p < 0.001), and Asian race with higher recanalization risk (OR = 1.65, p = 0.045). Additional predictors of recanalization included advanced disease (CEAP 6; p < 0.05), while the ablation of the great, anterior, or small saphenous veins was protective compared with perforator veins (all p < 0.001). Predictors of EHIT included older age (p < 0.0001) and prior recanalization (p < 0.0001), while laser ablation was associated with a significantly lower EHIT risk compared with radiofrequency (p < 0.0001). Baseline disease severity also varied: Black patients were more likely to present with advanced disease (CEAP 5-6) than Hispanic and Asian patients (p < 0.0001). CONCLUSIONS:Endovenous ablation is a safe and effective treatment for chronic venous insufficiency across different racial/ethnic groups, with overall success rates of 95-96%. However, racial differences were observed in complication rates and baseline severity: Black patients had higher EHIT risk and more advanced disease at presentation, while Asian patients had a slightly higher recanalization risk. These findings highlight the need for tailored post-ablation surveillance and improved early access to care to address differences in minority populations.
PMID: 42413658
ISSN: 2213-3348
CID: 6063442
Inframalleolar venous ulcers heal with Unna boot therapy
Karren, Camille L; Gill-Jones, Nisha D S; Robbins, Justin M; Ascher, Enrico; Ascher, Alexandra N; Hingorani, Anil
INTRODUCTION/BACKGROUND:This study highlights the presentation of inframalleolar ulcers in venous disease not classically described their wound healing factors, recurrence rate, and response to Unna boot treatment with adjunct endovenous and/or iliac vein stenting treatments. METHODS:This retrospective single-center study included 71 office-based patients with inframalleolar venous ulcers treated between May 2012 and May 2023. Of the 71 patients evaluated, 12 presented with bilateral ulcers, resulting in a total of 83 limbs. Patient demographics including age, sex, ulcer etiology, ulcer location, diabetes status, and treatment modality were evaluated. All patients presented with bilateral leg swelling and venous reflux greater than 500ms suggestive of venous insufficiency. Initially, patients were required to have palpable pedal pulses and a normal ankle-brachial index (ABI) for inclusion. Over time, inclusion criteria were broadened to accept patients with mixed arterial-venous disease, provided their ABI was greater than 0.6. Patients with isolated arterial pathology and an ABI < 0.6 and diabetic neuropathic ulcer etiology were excluded from this study. Patients received compression therapy that included an elastic ACE wrap and an inelastic Unna boot formulated with calamine, zinc oxide, and glycerin, both applied by trained medical assistants. Sixty-five patients received additional endovenous and/or iliac vein stenting treatments. RESULTS:The mean patient age was 67 years +/-14 years (range 25-96 years). Of the 71 patients treated, 12 (mean 16.9%, SE 4.45%) presented with ulcers on both of their limbs resulting in a total of 83 limbs treated. All ulcers were treated with weekly Unna boots with an average treatment duration of 12 weeks +/- 23 weeks (range 1-181 weeks), and median treatment duration of 5 weeks. After wound healing patients were followed for a mean duration of 16 +/- 28 months. The rate of success of > 90% healing for inframalleolar ulcers was 51.8%. Factors associated with wound healing were ulcers that were primarily venous in nature as opposed to mixed (p=0.01). Heel ulcers were not associated with inferior wound healing (p=0.10) as compared to other locations but were associated with higher rates of recurrence (p=0.002). 26.76% of patients had recurring ulcers while 45.13% did not, 8.4% of ulcers were still actively being treated with Unna boots and 19.71% were lost to follow-up. Improved healing of inframalleolar ulcers was significantly associated with the presence of a concomitant supramalleolar ulcer on the same limb (p=0.02). CONCLUSIONS:This study brings attention to the uncommon presentation of inframalleolar ulcers in venous stasis disease and is driven by the observation that bilateral leg swelling can lead to poor wound healing. Compression therapy using Unna boots is easily accessible, cost-effective, and should be considered as it offers significant therapeutic benefit in this patient population.
PMID: 42235637
ISSN: 2213-3348
CID: 6044162
Innovative Wound Management of Refractory Venous Ulcers with Topical Oxygen Therapy
Williams, Zachary E; Singh, Impreet; Marks, Natalie; Ascher, Enrico; Hingorani, Anil P
OBJECTIVE:Topical Oxygen therapy (tOT) is a novel treatment method capable of expediting granulation tissue formation in patients with non-healing lower extremity venous leg ulcers (VLUs). tOT provides cyclic oxygen with compression and is able to be administered at home, unlike chamber-based oxygen therapy. Although previous randomized prospective trials have demonstrated effectiveness of tOT in treating ulcers of diabetic etiology, its ability to promote healing in refractory venous ulcers requires additional exploration. Thus, we investigated preliminary outcomes of tOT administration in treatment-resistant VLUs. METHODS:We conducted a single-center retrospective review of treatment outcomes among 31 patients with 32 total extremities with VLUs following longitudinal administration of tOT. All patients received managed Medicaid approval for tOT after each ulcer failed to resolve following multiple alternative therapies, including Unnaboot compression, sclerotherapy, thermal ablation, iliac vein stenting, and debridement. Patient response to tOT was determined by assessing mid-treatment progression of ulcer length and width, in addition to final ulceration status at the conclusion of therapy. Mean treatment length, total ulcer duration, peak ulcer length, and peak ulcer width were determined for each patient and compared between healed and unhealed VLUs. RESULTS:Average age across all individuals was 73±19 years (range 27-99). 14 (45%) patients were male, with a racial breakdown of 18 (58%) White, 5 (16%) Hispanic, 6 (19%) Black, and 2 (6%) Asian patients. Comorbid conditions included hypertension in 31 (100%) patients, hyperlipidemia in 15 (48%), and diabetes in 12 (39%). 4 (13%) patients demonstrated a former history of smoking while 3 (10%) patients were currently using tobacco products during the study period. Total duration across all VLUs was 1075±1004 days. Average duration of tOT was 265±233 days, while average pre-treatment ulcer duration was 718±842 days. Mean ulcer length was 7.6±6.8 cm and mean ulcer width was 5.7±5.0 cm (range 2-24 cm for both). Following tOT administration, 11 (34%) VLUs healed entirely, 9 (28%) ulcers improved but did not completely heal, 8 (25%) remained unchanged, and 4 (13%) worsened despite treatment. Median time to healing among the 11 VLUs which healed completely was 121 days. For ulcers that did not heal, the mean duration of tOT was 333±261 days. No differences were observed in the pretreatment VLU duration (p=0.54), maximum length (p=0.50) or maximum width (p=0.80) of healed versus unhealed VLUs. CONCLUSIONS:20 (62.5%) of the 32 refractory VLUs treated with tOT either decreased in size or healed entirely after failing multiple previous therapies. 3 (27.3%) of the 11 ulcers which healed completely recurred following topical oxygen therapy.
PMID: 41864536
ISSN: 2213-3348
CID: 6017272
Proximal Tumescence During Treatment of Saphenous Veins with Polidocanol Endovenous Microfoam Provides Successful Ablation of Larger Veins and Predicts Reduced Microfoam Volume
Marks, Natalie; Ascher, Enrico; Hingorani, Anil; Fang, John
BACKGROUND:Perivenous tumescence with saline or a dilute lidocaine solution is routinely used for thermal ablation of refluxing superficial lower extremity veins to displace sensitive structures away from the thermal probe and provide better contact with the treated venous endothelium. In this study we introduce an adjunctive technique of tumescence infiltration at the most efferent segment of refluxing saphenous veins treated with 1% polidocanol endovenous microfoam (PEM). We hypothesize that by reducing the vein diameter, Proximal Tumescence (PT) prolongs apposition time of PEM to the endothelium by delaying venous outflow and microfoam propagation speed. We evaluated PT effects on vein closure, volume of PEM used as well as the incidence of superficial venous thrombosis (SVT) and ablation related thrombus extension (ARTE). METHODS:A single institution retrospective study was performed with PEM ablations for the above knee great saphenous vein (AK-GSV), below knee GSV (BK-GSV), and small saphenous vein (SSV) by two operators over a 12-month period. Duplex ultrasonography (DUS) within 3-to-7 days after ablation followed by a serial surveillance DUS schedule were used to evaluate for vein closure, VT, and ARTE per institutional protocol. Any treated vein segment found to be completely or partially patent with reflux after treatment was deemed an ablation failure. Demographics and outcomes of tumescent PEM ablations (T-PEM) were compared with non-tumescent PEM (NT-PEM) through univariate and generalized estimating equation modeling. RESULTS:Between June 2023 and May 2024, 183 adult patients (64 male, 119 female) treated with 1% PEM in 246 lower extremities (113 right, 133 left) met study criteria. Nineteen patients without documented follow up DUS were excluded from this study. Overall, 293 ablations (23 AK-GSV, 199 BK-GSV, 71 SSV) were performed with a mean PEM volume of 2.8cc (SD=0.6cc) per ablation with a combined closure rate of 91.8% (269 of 293). One hundred and nineteen (40.6%) ablations were augmented with PT (mean tumescence volume = 6cc, SD=2.4cc, range=3cc to 16cc). Veins treated with T-PEM were significantly larger (mean vein diameter=4.8mm, SD=1.3mm) than veins treated with NT-PEM (mean vein diameter=4.0mm, SD=0.9mm, p<.001). There were no significant differences in patient age (p=.37), sex (p=.06), laterality (p=.29), preoperative CEAP clinical severity scores (p=.34), PEM volume used (p=.09), VT (p=.65), ARTE (p=.41), or rate of treatment success (p=.16) on univariate comparison of T-PEM and NT-PEM ablations. Generalized estimating equation regression predicts lower microfoam volume use with PT (B=-0.4, p=.003) and similar treatment success rates when correcting for inter-operator variability. CONCLUSION/CONCLUSIONS:Proximal tumescence is a safe and effective adjunct to PEM ablation that provides high short and mid-term closure rates with low ARTE incidence for large and small saphenous veins. PT is associated with reduced microfoam volume use.
PMID: 41352641
ISSN: 2213-3348
CID: 5975442
Expansion of WallStents® after Initial Deployment in Nonthrombotic Iliac Vein Lesions
Gill-Jones, Nisha D S; Robbins, Justin M; Gadula, Srinanda; Hingorani, Amrit; Nguyen, Hoang; Ostrozhynskyy, Yuriy; Aurshina, Afsha; Marks, Natalie; Ascher, Enrico; Hingorani, Anil
BACKGROUND:To determine the structural changes of Wallstents (Boston Scientific, Natick, MA) in vivo following deployment in iliac veins. METHODS:This retrospective single-center study was performed from September 2012 to April 2013 and included 100 office-based patients who underwent initial stent placement for nonthrombotic iliac vein lesions with Wallstent as well as a second procedure for stenting of the contralateral iliac vein. Measurements were obtained with marker balloons and the diameters of the stents were compared at the time of the index procedure to the secondary procedure. RESULTS:The average time between the 2 procedures was 28 days (range 3-237, SD ± 39.89). The overall average stent diameter after the index procedure was 16.38 mm (range 10.95-21.45, SD ± 2.24). The overall average stent diameter of the index stent when remeasured during the second intervention was 17.58 mm (range 12.84-24.11, SD ± 2.38, P = 0.0003), which was significantly different from the initial measurements. There was no difference when comparing changes in stent diameter by gender or laterality of procedure. However, there was a significant difference in expansion of stents when placed in the common iliac vein versus the external iliac or common femoral veins. CONCLUSIONS:This study shows that self-expanding Wallstents can continue to expand days to weeks in vivo following initial deployment. Additionally, we found that the change in diameter from initial placement to follow-up was more significant in stents placed in the proximal and middle segments of the common iliac vein. CLINICAL RELEVANCE/CONCLUSIONS:Wallstents are durable implants designed to last within a patient for the rest of their life, it is important to understand the structural changes occurring after their placement. This study allows for a better understanding of Wallstent dynamics in vivo.
PMID: 39098725
ISSN: 1615-5947
CID: 5730432
Contraindications to tissue plasminogen activator thrombolysis for acute lower extremity ischemia
Singh, Nikita; Santos, Tyler; Ali, Ali Basil; Khan, Hason; Kibrik, Pavel; Storch, Jason; Bai, Halbert; Awad, Mark; Patel, Ronak; Huber, Michael; Ascher, Enrico; Marks, Natalie; Hingorani, Anil
OBJECTIVE:Previous randomized prospective trials have demonstrated the effectiveness of transcatheter tissue plasminogen activator (tPA) thrombolysis in treating acute limb ischemia (ALI) compared to conventional surgery. These pivotal trials have also highlighted contraindications for these procedures. Given recent advancements in techniques and technology, our aim is to reassess the relevance of these contraindications in contemporary practice. METHODS:A retrospective chart analysis was performed utilizing the inpatient medical records of consecutive individuals who underwent tPA treatment for acute limb ischemia (ALI) from September 2016 to April 2022. Inclusion criteria encompassed patients aged 18 and above displaying clinical symptoms and imaging evidence of ALI within 14 days. All patients received tPA with suction thrombectomy following the fast-track thrombolysis protocol. In cases where a persistent thrombus or stenosis was detected, catheter-directed thrombolysis was considered overnight, and patients underwent angiography and reassessment in the operating room subsequently. RESULTS:= .771). Additionally, no amputations were observed within our population. CONCLUSIONS:In light of our study results and advancements in endovascular therapies, we can now safely and efficiently treat patients who were previously considered contraindicated for such treatments. It is essential to individualize treatments and carefully balance the risks and benefits of endovascular versus open surgical revascularization for these patients. Additionally, we believe that the nearly 30-year-old guidelines for endovascular therapies need to be revisited and updated to align with modern technology.
PMID: 39120517
ISSN: 1708-539x
CID: 5730942
Venous stenting versus venous ablation
Alsheekh, Ahmad; Kibrik, Pavel; Marks, Natalie; Ascher, Enrico; Hingorani, Anil
BACKGROUND:The minimally invasive procedures of venous ablation and iliac vein stenting are evolving treatment options for venous insufficiency. Yet, there are no studies directly comparing the outcome of these procedures. We performed a survey on patients who had both procedures, to determine if either procedure helped more and if there is any other clinical factor related to the outcome. METHOD/METHODS:We collected data between Jan 2012 and Feb 2019 from 726 patients who failed to improve swelling after conservative management. The patients underwent iliac vein stenting and vein ablations. We recorded patient assessment of the leg immediately after completion of both procedures. Follow-up was performed using in-person questionnaires by asking if improvement in lower extremity swelling occurred and if so, which procedure helped more. RESULTS:= 0.095). CONCLUSION/CONCLUSIONS:In this qualitative assessment, preliminary data suggest that the comparative role of iliac vein stent versus endovenous ablation warrants further study. The data were broadly distributed, and neither procedure was superior. In addition, 16% of the patients stated that neither procedure helped. The age of patients may also play a role in their procedure preferences and their subjective assessment for improvement.
PMID: 39186809
ISSN: 1708-539x
CID: 5729552
The unknown story of an early intraluminal inferior vena cava filter prototype
Moreno, Oscar; Roth, Alexis; Ascher, Enrico; Hingorani, Anil P
PMID: 38945362
ISSN: 2213-3348
CID: 5732612
Transcarotid Artery Revascularization for Symptomatic Retropharyngeal Internal Carotid Artery Stenosis
Ettleson, Ari; Robbins, Justin; Ascher, Enrico; Hingorani, Anil
Retropharyngeal internal carotid artery (ICA) is a rare, yet well-described anatomical variant that poses significant challenges to the management of carotid artery stenosis. In this case report, we discuss the treatment of symptomatic ICA stenosis with a retropharyngeal ICA using the transcarotid artery revascularization (TCAR) technique. A 70-year-old female with comorbidities presented with neurological symptoms and severe ICA stenosis. After diagnostic evaluation, TCAR was chosen for surgical intervention. The patient did well postoperatively. This case emphasizes the importance of considering TCAR when treating ICA stenosis in patients with anatomic variation of ICA location. It also supports adding anatomic variants such as retropharyngeal ICA to the list of indications for TCAR.
PMID: 39163867
ISSN: 1938-9116
CID: 5680612