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Various Therapies for Lymphedema and Chronic Venous Insufficiency, Including a Multimodal At-Home Nonpneumatic Compression Treatment

Barnhart, Heather; Maldonado, Thomas; Rockson, Stanley G
Lymphedema and chronic venous insufficiency (CVI) affect millions of people and require lifelong management. Many compression options exist for the long-term management of these conditions; however, limitations in patient mobility and adherence are common. Current options for care often present challenges with adherence because they are time-intensive and cumbersome. Innovation is needed to improve compression options for patients with chronic edematous conditions, particularly because lymphedema and CVI benefit from combination interventions. In this narrative review, the authors focus on long-term management strategies for lymphedema and CVI and highlight a nonpneumatic compression device designed for ease of use in the management of lymphedema and CVI. Using a nonpneumatic compression device that combines multiple treatment modalities demonstrates improved efficacy, quality of life, and patient adherence.
PMID: 38353650
ISSN: 1538-8654
CID: 5635752

Anti-factor Xa as the preferred assay to monitor heparin for the treatment of pulmonary embolism

Zhu, Eric; Yuriditsky, Eugene; Raco, Veronica; Katz, Alyson; Papadopoulos, John; Horowitz, James; Maldonado, Thomas; Ahuja, Tania
INTRODUCTION/BACKGROUND:The mainstay of acute pulmonary embolism (PE) treatment is anticoagulation. Timely anticoagulation correlates with decreased PE-associated mortality, but the ability to achieve a therapeutic activated partial thromboplastin time (aPTT) with unfractionated heparin (UFH) remains limited. Although some institutions have switched to a more accurate and reproducible test to assess for heparin's effectiveness, the anti-factor Xa (antiXa) assay, data correlating a timely therapeutic antiXa to PE-associated clinical outcomes remains scarce. We evaluated time to a therapeutic antiXa using intravenous heparin after PE response team (PERT) activation and assessed clinical outcomes including bleeding and recurrent thromboembolic events. METHODS:This was a retrospective cohort study at NYU Langone Health. All adult patients ≥18 years with a confirmed PE started on IV UFH with >2 antiXa levels were included. Patients were excluded if they received thrombolysis or alternative anticoagulation. The primary endpoint was the time to a therapeutic antiXa level of 0.3-0.7 units/mL. Secondary outcomes included recurrent thromboembolism, bleeding and PE-associated mortality within 3 months. RESULTS:A total of 330 patients with a PERT consult were identified with 192 patients included. The majority of PEs were classified as sub massive (64.6%) with 87% of patients receiving a bolus of 80 units/kg of UFH prior to starting an infusion at 18 units/kg/hour. The median time to the first therapeutic antiXa was 9.13 hours with 93% of the cohort sustaining therapeutic anticoagulation at 48 hours. Recurrent thromboembolism, bleeding and mortality occurred in 1%, 5% and 6.2%, respectively. Upon univariate analysis, a first antiXa <0.3 units/ml was associated with an increased risk of mortality [27.78% (5/18) vs 8.05% (14/174), p = 0.021]. CONCLUSION/CONCLUSIONS:We observed a low incidence of recurrent thromboembolism or PE-associated mortality utilizing an antiXa titrated UFH protocol. The use of an antiXa based heparin assay to guide heparin dosing and monitoring allows for timely and sustained therapeutic anticoagulation for treatment of PE.
PMID: 37989523
ISSN: 1751-553x
CID: 5608542

The Natural History and Long-Term Follow-Up of Splenic Artery Aneurysms

Zhang, Jason; Ratner, Molly; Harish, Keerthi B; Speranza, Giancarlo; Hartwell, C Austen; Rao, Abhishek; Garg, Karan; Maldonado, Thomas; Sadek, Mikel; Jacobowitz, Glenn; Rockman, Caron
OBJECTIVES/OBJECTIVE:Though splenic artery aneurysms (SAAs) are the most common visceral aneurysm, there is a paucity of literature on the behavior of these entities. The objective of this study was to review the natural history of patients with SAA. METHODS:This single-institution retrospective analysis studied patients with SAA diagnosed by CT imaging between 2015 and 2019, identified by our institutional radiology database. Imaging, demographic, and clinical data was obtained via the electronic medical record. The growth rate was calculated for patients with radiologic follow-up. RESULTS:The cohort consisted of 853 patients with 890 SAA, of which 692 were female (81.2%). There were 37 women (5.3%) of childbearing age (15-50 years). Mean age at diagnosis was 70.9 years (range: 28-100) years. Frequently observed medical comorbidities included hypertension (70.2%), hypercholesterolemia (54.7%), and prior smoking (32.2%). Imaging indications included abdominal pain (37.3%), unrelated follow-up (28.0%) and follow-up of a previously noted visceral artery aneurysm (8.6%). The mean diameter at diagnosis was 13.3±6.3mm. Anatomical locations included the splenic hilum (36.0%), distal splenic artery (30.3%), mid-splenic artery (23.9%), and proximal splenic artery (9.7%). Radiographically, the majority were saccular aneurysms (72.4%) with calcifications (88.5%). One patient (38-year-old female) was initially diagnosed at the time of rupture of a 25mm aneurysm; this patient underwent immediate endovascular intervention with no complications. The mean clinical follow-up among 812 patients was 4.1 ± 4.0 years and the mean radiological follow-up among 514 patients was 3.8 ± 6.8 years. Of the latter, 122 patients (23.7%) experienced growth. Aneurysm growth rates for initial sizes < 10mm (n=123), 10-19mm (n=353), 20-29mm (n=34), and >30mm (n=4) were 0.166 mm/yr, 0.172 mm/yr, 0.383 mm/yr, and 0.246 mm/yr, respectively. Of the entire cohort, 27 patients (3.2%) eventually underwent intervention (81.5% endovascular), with the most common indications including size/growth criteria (70.4%) and symptom development (18.5%). On multivariate analysis, only prior tobacco use was significantly associated with aneurysm growth (p=.028). CONCLUSIONS:The majority of SAAs in this cohort remained stable in size, with few patients requiring intervention over mean follow-up of 4 years. Current guidelines recommending treatment of asymptomatic aneurysms >30mm appear appropriate given their slow progression. Despite societal recommendations for intervention for all SAAs among women of childbearing age, only a minority underwent vascular surgical consultation and intervention in this series, indicating that these recommendations are likely not well known in the general medical community.
PMID: 38081394
ISSN: 1097-6809
CID: 5589102

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

Chervonski, Ethan; Harish, Keerthi B; Rockman, Caron B; Sadek, Mikel; Teter, Katherine A; Jacobowitz, Glenn R; Berland, Todd L; Lohr, Joann; Moore, Colleen; Maldonado, Thomas S
OBJECTIVES/OBJECTIVE: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:> .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.
PMID: 38500300
ISSN: 1708-539x
CID: 5640272

Safety and efficacy of mechanical aspiration thrombectomy at 30 days for patients with lower extremity acute limb ischemia

Maldonado, Thomas S; Powell, Alex; Wendorff, Heiko; Rowse, Jarrad; Nagarsheth, Khanjan H; Dexter, David J; Dietzek, Alan M; Muck, Patrick E; Arko, Frank R; Chung, Jayer; ,
OBJECTIVE:Acute limb ischemia (ALI) is associated with high rates of amputation and consequent morbidity and mortality. The objective of this study is to report on the safety and efficacy of aspiration thrombectomy using the Indigo Aspiration System in patients with lower extremity (LE) ALI. METHODS:The STRIDE study was an international, multicenter, prospective, study that enrolled 119 participants presenting with LE-ALI. Patients were treated firstline with mechanical thrombectomy using the Indigo Aspiration System, before stenting or angioplasty, or other therapies as determined by treating physician. The primary end point was target limb salvage at 30 days after the procedure. Secondary end points within 30 days included technical success, defined as core laboratory-adjudicated Thrombolysis in Myocardial Infarction (TIMI) 2/3 flow rate immediately after the procedure, changes in modified Society for Vascular Surgery runoff score, improvement of Rutherford classification compared with before the procedure, patency, rate of device-related serious adverse events, and major periprocedural bleeding. Secondary end points that will be evaluated at 12 months include target limb salvage and mortality. RESULTS:Of the 119 participants enrolled at 16 sites, the mean age was 66.3 years (46.2% female). At baseline (n = 119), ischemic severity was classified as Rutherford I in 10.9%, Rutherford IIa in 54.6%, and Rutherford IIb in 34.5%. The mean target thrombus length was 125.7 ± 124.7 mm. Before the procedure, 93.0% (of patients 107/115) had no flow (TIMI 0) through the target lesion. The target limb salvage rate at 30 days was 98.2% (109/111). The rate of periprocedural major bleed was 4.2% (5/119) and device-related serious adverse events was 0.8% (1/119). Restoration of flow (TIMI 2/3) was achieved in 96.3% of patients (105/109) immediately after the procedure. The median improvement in the modified Society for Vascular Surgery runoff score (before vs after the procedure) was 6.0 (interquartile range, 0.0-11.0). Rutherford classifications also improved after discharge in 86.5% of patients (83/96), as compared with preprocedural scores. Patency at 30 days was achieved in 89.4% of patients (101/113). CONCLUSIONS:In the STRIDE (A Study of Patients with Lower Extremity Acute Limb Ischemia to Remove Thrombus with the Indigo Aspiration System) study, aspiration thrombectomy with the Indigo System provided a safe and effective endovascular treatment for patients with LE-ALI, resulting in a high rate (98.2%) of successful limb salvage at 30 days, with few periprocedural complications.
PMID: 37931885
ISSN: 1097-6809
CID: 5628162

Duplex ultrasound and cross-sectional imaging in carotid artery occlusion diagnosis

Speranza, Giancarlo; Harish, Keerthi; Rockman, Caron; Sadek, Mikel; Jacobowitz, Glenn; Garg, Karan; Chang, Heepeel; Teter, Katherine; Maldonado, Thomas S
OBJECTIVE:Investigations into imaging modalities in the diagnosis of extracranial carotid artery occlusion (CAO) have raised questions about the inter-modality comparability of duplex ultrasound (DUS) and cross-sectional imaging (CSI). This study examines the relationship between DUS and CSI diagnoses of extracranial CAO. METHODS:This single-institution retrospective analysis studied patients with CAO diagnosed by DUS from 2010 to 2021. Patients were identified in our office-based accredited vascular laboratory database. Imaging and clinical data was obtained via our institutional electronic medical record. Primary outcome was discrepancy between DUS and CSI modalities. Secondary outcomes included incidence of stroke and intervention subsequent to CAO diagnosis. RESULTS:Of our 140-patient cohort, 95 patients (67.9%) had DUS follow-up (mean, 42.7 ± 31.3 months). At index duplex, 68.0% of individuals (n = 51) were asymptomatic. Seventy-five patients (53.6%) had CSI of the carotids after DUS CAO diagnosis; 18 (24%) underwent magnetic resonance imaging and 57 (76%) underwent computed tomography. Indications for CSI included follow-up of DUS findings of carotid stenosis/occlusion (44%), stroke/transient ischemic attack (16%), other symptoms (12%), preoperative evaluation (2.7%), unrelated pathology follow-up (9.3%), and outside institution imaging with unavailable indications (16%). When comparing patients with CSI and those without, there were no differences with regard to symptoms at diagnosis, prior neck interventions, or hypertension. There was a significant difference between cross-sectionally imaged and non-imaged patients in anti-hypertensive medications (72% vs 53.8%; P = .04). Despite initial DUS diagnoses of carotid occlusion, 10 patients (13.3%) ultimately had CSI indicating patent carotids. Four of these 10 patients had stenoses of ∼99% (with 1 string sign), four of 70% to 99%, one of 50% to 69%, and one of less than 50% on CSI. The majority of patients (70%) had CSI within 1 month of the index ultrasound. There were no significant relationships between imaging discrepancies and body mass index, heart failure, upper body edema, carotid artery calcification, and neck hardware. Eight individuals (10.7%) underwent ipsilateral revascularization; 62.5% (n = 5) were carotid endarterectomy procedures, and the remaining three procedures were a transcervical carotid revascularization, subclavian to internal carotid artery bypass, and transfemoral carotid artery stenting. Eight patients (10.7%) underwent contralateral revascularization, with the same distribution of procedures as those ipsilateral to occlusions. Two of the 10 patients with discrepancies underwent carotid endarterectomy, and one underwent carotid stenting. CONCLUSIONS:In our experience, duplex diagnosis of CAO is associated with a greater than 10% discordance when compared with CSI. These patients may benefit from closer surveillance as well as confirmatory computed tomography or magnetic resonance angiography. Further work is needed to determine the optimal diagnostic modality for CAO.
PMID: 37992947
ISSN: 1097-6809
CID: 5608712

The Effect of Ipsilateral Carotid Revascularization on Contralateral Carotid Duplex Parameters in Patients with Bilateral Carotid Stenosis

Ratner, Molly; Rockman, Caron; Chandra, Pratik; Cayne, Neal; Jacobowitz, Glenn; Lamparello, Patrick J; Maldonado, Thomas; Sadek, Mikel; Berland, Todd; Garg, Karan
BACKGROUND:Duplex-derived velocity measurements are often used to determine the need for carotid revascularization. There is evidence that severe ipsilateral carotid stenosis can cause artificially elevated velocities in the contralateral carotid artery, which may decrease following ipsilateral revascularization. The objective of this study was to determine if contralateral carotid artery duplex velocities decrease following ipsilateral carotid endarterectomy or stenting procedures. METHODS:This is a single institutional retrospective study of prospectively collected data on all patients who underwent carotid revascularization from 2013 to 2021. Patients with immediate preoperative and first postoperative Duplex scan within 4 months of carotid revascularization at our vascular laboratory were included for analysis. Patients with contralateral occlusion were excluded. Duplex criteria used to define moderate (50-69%) and severe (>70%) stenosis were systolic velocity ≥125 cm/sec and ≥230 cm/sec, respectively. RESULTS:Between 2013 and 2021, 129 patients with bilateral carotid stenosis underwent either carotid endarterectomy (98) or a stenting procedure (31). The majority of patients (90%) underwent intervention for severe stenosis. Preoperatively, the contralateral artery was categorized as severe in 30.4% patients. After ipsilateral carotid revascularization, 86 patients (67.2%) saw a decrease in the contralateral artery peak systolic velocity (PSV), while the remaining remained stable or increased. Fifty-four patients had a change in designated stenosis severity in the contralateral artery. Between the carotid endarterectomy and stenting cohorts, there was no significant difference in the proportion of patients whose contralateral velocity decreased (69.4% vs. 61.3%, P = 0.402). Patients with coronary artery disease and diabetes were significantly less likely to experience a decrease in the contralateral artery PSV after ipsilateral intervention (P = 0.018 and P = 0.033). CONCLUSIONS:In patients with bilateral carotid disease, ipsilateral revascularization can change the contralateral artery velocity and perceived disease severity. Most patients were noted to have a decrease in the contralateral artery PSV, although almost one-third either stayed stable or increased. On multivariable analysis, patients with coronary artery disease and diabetes were less likely to see a decrease in the contralateral artery PSV after intervention. Patients who are at risk for artificial elevation of the contralateral artery may warrant a re-evaluation of the contralateral artery after ipsilateral intervention. These patients are potentially better assessed with axial imaging, although further research is needed.
PMID: 37918660
ISSN: 1615-5947
CID: 5620402

Natural history of internal carotid artery stenosis progression

Harish, Keerthi B; Speranza, Giancarlo; Rockman, Caron B; Sadek, Mikel; Jacobowitz, Glenn R; Garg, Karan; Teter, Katherine A; Maldonado, Thomas S
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.
PMID: 37925038
ISSN: 1097-6809
CID: 5607162

Current Medicare reimbursement for complex endovascular aortic repair is inadequate based on results from a multi-institutional cost analysis

Brinster, Clayton J; Money, Samuel R; Hayson, Aaron; Gurdian, René; Milner, Ross; Polcari, Kayla; Asirwatham, Mark; Arnaoutakis, Dean J; Li, Chong; Maldonado, Thomas; Cheung, Dillon; Meltzer, Andrew
OBJECTIVE:Complex endovascular juxta-, para- and suprarenal abdominal aortic aneurysm repair (comEVAR) is frequently accomplished with commercially available fenestrated (FEVAR) devices or off-label use of aortoiliac devices with parallel branch stents (chEVAR). We sought to evaluate the implantable vascular device costs incurred with these procedures as compared with standard Medicare reimbursement to determine the financial viability of comEVAR in the modern era. METHODS:Five geographically distinct institutions with high-volume, complex aortic centers were included. Implantable aortoiliac and branch stent device cost data from 25 consecutive, recent, comEVAR in the treatment of juxta-, para-, and suprarenal aortic aneurysms at each center were analyzed. Cases of rupture, thoracic aneurysms, reinterventions, and physician-modified EVAR were excluded, as were ancillary costs from nonimplantable equipment. Data from all institutions were combined and stratified into an overall cost group and two, individual cost groups: FEVAR or chEVAR. These groups were compared, and each respective group was then compared with weighted Medicare reimbursement for Diagnosis-Related Group codes 268/269. Median device costs were obtained from an independent purchasing consortium of >3000 medical centers, yielding true median cost-to-institution data rather than speculative, administrative projections or estimates. RESULTS:A total of 125 cases were analyzed: 70 FEVAR and 53 chEVAR. Two cases of combined FEVAR/chEVAR were included in total cost analysis, but excluded from direct FEVAR vs chEVAR comparison. Median Medicare reimbursement was calculated as $35,755 per case. Combined average implantable device cost for all analyzed cases was $28,470 per case, or 80% of the median reimbursement ($28,470/$35,755). Average FEVAR device cost per case ($26,499) was significantly lower than average chEVAR cost per case ($32,122; P < .002). Device cost was 74% ($26,499/$35,755) of total reimbursement for FEVAR and 90% ($32,122/$35,755) for chEVAR. CONCLUSIONS:Results from this multi-institutional analysis show that implantable device cost alone represents the vast majority of weighted total Medicare reimbursement per case with comEVAR, and that chEVAR is significantly more costly than FEVAR. Inadequate Medicare reimbursement for these cases puts high-volume, high-complexity aortic centers at a distinct financial disadvantage. In the interest of optimizing patient care, these data suggest a reconsideration of previously established, outdated, Diagnosis-Related Group coding and Medicare reimbursement for comEVAR.
PMID: 37734569
ISSN: 1097-6809
CID: 5623682

Prior Authorization Requirements In The Office-Based Laboratory Setting Are Administratively Inefficient And Threaten Timeliness Of Care

Harish, Keerthi B; Chervonski, Ethan; Speranza, Giancarlo; Maldonado, Thomas S; Garg, Karan; Sadek, Mikel; Rockman, Caron B; Jacobowitz, Glenn R; Berland, Todd L
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, 1,854 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 prior authorization determination by a mean 14.2±18.3 working days. An additional 6% (n=8) of procedures were performed in the interest of time prior to final determination. Of the 7 terminally denied procedures, 57% (n=4) were performed at cost to the practice based on clinical judgment. CONCLUSIONS:Utilizing prior authorization appeals mechanisms, while administratively onerous, resulted in the overturning of most initial denials.
PMID: 38135169
ISSN: 1097-6809
CID: 5611912