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Optimal medical therapy is lacking in patients undergoing intervention for symptomatic carotid artery stenosis and protects against larger areas of cerebral infarction
Teter, Katherine; Willems, Loes; Harish, Keerthi; Negash, Bruck; Warle, Michiel; Rockman, Caron; Torres, Jose; Ishida, Koto; Jacobowitz, Glenn; Garg, Karan; Maldonado, Thomas
OBJECTIVES/OBJECTIVE:Carotid interventions are indicated for both patients with symptomatic and a subset of patients with severe asymptomatic carotid artery stenosis (CAS). Symptomatic CAS accounts for up to 12%-25% of overall carotid interventions, but predictors of symptomatic presentation remain poorly defined. The aim of this study was to identify factors associated with symptomatic CAS in our patient population. METHODS:Between January 2015 and February 2022, an institutional retrospective cohort study of prospectively collected data on patients undergoing interventions for CAS was performed. Procedures included carotid endarterectomy (CEA), transcarotid artery revascularization (TCAR), and transfemoral carotid artery stenting (TF-CAS). Demographic data, comorbidities, procedural details, and anatomic features from various imaging modalities were collected. Comparisons were made between symptomatic (symptoms within the prior 6 months) and asymptomatic patients. RESULTS:< .001), and symptomatic patients with ulcerated plaques more frequently had less than 50% compared to moderate/severe CAS. Nine patients who presented with symptoms had mild CAS and underwent intervention. CONCLUSIONS:Symptomatic CAS was associated with a history of remote prior symptoms and lack of anti-platelet therapy at time of presentation. Furthermore, symptomatic patients not on anti-platelet agents were more likely to have a greater area of parenchymal involvement when presenting with stroke and symptomatic patients with ulcerated plaques were more likely to have mild CAS, suggesting the role of plaque instability in symptomatic presentation. These findings underscore the importance of appropriate medical management and adherence in all patients with CAS and perhaps a role for more frequent surveillance in those with potentially unstable plaque morphology.
PMID: 38876778
ISSN: 1708-539x
CID: 5669572
Comparing Management Strategies in Patients With Clot-in-Transit
Zhang, Robert S; Yuriditsky, Eugene; Zhang, Peter; Elbaum, Lindsay; Bailey, Eric; Maqsood, Muhammad H; Postelnicu, Radu; Amoroso, Nancy E; Maldonado, Thomas S; Saric, Muhamed; Alviar, Carlos L; Horowitz, James M; Bangalore, Sripal
BACKGROUND/UNASSIGNED:Clot-in-transit is associated with high mortality, but optimal management strategies remain uncertain. The aim of this study was to compare the outcomes of different treatment strategies in patients with clot-in-transit. METHODS/UNASSIGNED:This is a retrospective study of patients with documented clot-in-transit in the right heart on echocardiography across 2 institutions between January 2020 and October 2023. The primary outcome was a composite of in-hospital mortality, resuscitated cardiac arrest, or hemodynamic decompensation. RESULTS/UNASSIGNED:=0.067). CONCLUSIONS/UNASSIGNED:In this study of CBT in patients with clot-in-transit, CBT or systemic thrombolysis was associated with a significantly lower rate of adverse clinical outcomes, including a lower rate of death compared with anticoagulation alone driven by the CBT group. CBT has the potential to improve outcomes. Further large-scale studies are needed to test these associations.
PMID: 38841833
ISSN: 1941-7632
CID: 5665552
Predicting Pulmonary Embolism in Total Joint Arthroplasty Patients A Pilot Study
Chen, Kevin K; Anoushiravani, Afshin A; Mercuri, John; Nardi, Michael A; Berger, Jeffrey; Maldonado, Thomas; Iorio, Richard
Postoperative venous thromboembolism (VTE) is a common and costly complication following total joint arthroplasty (TJA). Development of a refined thrombophilic screening panel will better equip clinicians to identify patients at high-est risk for developing VTEs. In this pilot study, 62 high-risk TJA recipients who had developed pulmonary emboli (PE) within 90-days of surgery were eligible to participate. Of these patients, 14 were enrolled and subsequently adminis-tered a pre-determined panel of 18 hematologic tests with the aim of identifying markers that are consistently elevated or deficient in patients developing PE. A separate cohort of seven high-risk TJA recipients who did not report a symp-tomatic VTE within 90-days of surgery were then enrolled and Factor VIII and lipoprotein(a) levels were assessed. The most common aberrance was noted in 10 patients (71.4%) who had elevated levels of Factor VIII followed by five patients (35.7%) who had elevated levels of lipoprotein(a). Factor VIII was significantly prevalent (p < 0.001) while lipoprotein(a) failed to achieve statistical significance (p = 0.0708). Of the patients who were within normal limits of Factor VIII, three-fourths were "high-normal" with Fac-tor VIII levels within 5% of the upper limit of normal. This study demonstrates the potential utility of this hematologic panel as part of a perioperative screening protocol aimed at identifying patients at risk for developing VTEs. However, future larger scale studies assessing the capabilities and limitations of our findings are warranted.
PMID: 38739660
ISSN: 2328-5273
CID: 5658582
Safety and efficacy of endovenous ablation in patients with a history of deep vein thrombosis
Chervonski, Ethan; Muqri, Furqan; Jacobowitz, Glenn R; Rockman, Caron B; Maldonado, Thomas S; Berland, Todd L; Garg, Karan; Cayne, Neal S; Sadek, Mikel
OBJECTIVE:Endovenous ablation is the standard of care for patients with symptomatic superficial venous insufficiency. For patients with a history of deep vein thrombosis (DVT), concern exists for an increased risk of postprocedural complications, particularly venous thromboembolism. The objective of this study was to evaluate the safety and efficacy of endovenous thermal ablation in patients with a history of DVT. METHODS:The national Vascular Quality Initiative Varicose Vein Registry was queried for superficial venous procedures performed from January 2014 to July 2021. Limbs treated with radiofrequency or laser ablation were compared between patients with and without a DVT history. The primary safety end point was incident DVT or endothermal heat-induced thrombosis (EHIT) II-IV in the treated limb at <3 months of follow-up. The secondary safety end points included any proximal thrombus extension (ie, EHIT I-IV), major bleeding, hematoma, pulmonary embolism, and death due to the procedure. The primary efficacy end point was technical failure (ie, recanalization at <1 week of follow-up). Secondary efficacy end points included the risk of recanalization over time and the postprocedural change in quality-of-life measures. Outcomes stratified by preoperative use of anticoagulation (AC) were also compared among those with prior DVT. RESULTS:Among 33,892 endovenous thermal ablations performed on 23,572 individual patients aged 13 to 90 years, 1698 patients (7.2%) had a history of DVT. Patients with prior DVT were older (P < .001), had a higher body mass index (P < .001), were more likely to be male at birth (P < .001) and Black/African American (P < .001), and had greater CEAP classifications (P < .001). A history of DVT conferred a higher risk of new DVT (1.4% vs 0.8%; P = .03), proximal thrombus extension (2.3% vs 1.6%; P = .045), and bleeding (0.2% vs 0.04%; P = .03). EHIT II-IV, pulmonary embolism, and hematoma risk did not differ by DVT history (P = NS). No deaths from treatment occurred in either group. Continuing preoperative AC in patients with prior DVT did not change the risk of any complications after endovenous ablation (P = NS) but did confer an increased hematoma risk among all endovenous thermal ablations and surgeries (P = .001). Technical failure was similar between groups (2.0% vs 1.2%; P = .07), although a history of DVT conferred an increased recanalization risk over time (hazard ratio, 1.90; 95% confidence interval, 1.46, 2.46; P < .001). The groups had comparable improvements in postprocedural venous clinical severity scores and Heaviness, Aching, Swelling, Throbbing, and Itching scores (P = NS). CONCLUSIONS:Endovenous thermal ablation for patients with a history of DVT was effective. However, appropriate patient counseling regarding a heightened DVT risk, albeit still low, is critical. The decision to continue or withhold AC preoperatively should be tailored on a case-by-case basis.
PMID: 38677553
ISSN: 2213-3348
CID: 5657962
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
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
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
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
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
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