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Endovascular Treatment of Popliteal Artery Aneurysms Has Comparable Long-Term Outcomes to Open Repair with Shorter Length of Stay

Shah, Noor G; Rokosh, Rae S; Garg, Karan; Safran, Brent; Rockman, Caron B; Maldonado, Thomas S; Sadek, Mikel; Lamparello, Patrick; Jacobowitz, Glenn R; Barfield, Michael E; Veith, Frank; Cayne, Neal S
OBJECTIVE:Over the past two decades, the treatment of popliteal artery aneurysms (PAAs) has undergone a transformation. While open surgical repair (OR) remains the gold standard for treatment, endovascular repair (ER) has become an attractive alternative in select patient populations. The objective of this study was to compare the outcomes of open versus endovascular repair of PAAs at a single institution. METHODS:We performed a retrospective chart review of all patients between 1998 and 2017 who underwent repair for PAA. Patient baseline, anatomic, and operative characteristics as well as outcomes were compared between the open and endovascular cohorts. The intervention and treatment were at the discretion of the surgeon. RESULTS:Between 1998 and 2017, a total of 64 patients underwent repair of 73 PAAs at our tertiary care center. Twenty-nine patients with 33 PAAs underwent OR, and 35 patients with 40 PAAs underwent ER. When comparing the 2 cohorts, there were no statistically significant differences in demographic characteristics such as age, gender, or number of run-off vessels. There were significantly more patients in the ER group (21/53%) than the OR group (7/21%) with hyperlipidemia (p=.008) and a prior carotid intervention (6% vs. 0%, p=.029). Overall, the presence of symptoms was similar amongst the two groups; however, patients in the OR group had a significantly higher number of patients presenting with acute ischemia (p=.01). Length of stay (LOS) was significantly shorter in the ER cohort (mean 1.8 days [1-11]) compared to the OR group (5.4 days [2-13]) (p<.0001). There was no significant difference in primary or secondary patency rates between the two groups. In the ER group, good runoff (≥2 vessels) was a positive predictor for primary patency at 1 year (3.36 [1.0-11.25]), however, it was not in the OR group. Post-operative single and/or dual anti-platelet therapy did not affect primary patency in either cohort. CONCLUSIONS:The results of our study demonstrate that ER of PAAs is a safe and durable option with comparable patency rates to OR and a decreased LOS, with good run-off being a positive predictor for primary patency in the ER cohort.
PMID: 33957229
ISSN: 1097-6809
CID: 4866682

Statin Use Reduces Mortality in Patients Who Develop Major Complications After Transcarotid Artery Revascularization [Meeting Abstract]

Chang, H; Rockman, C B; Jacobowitz, G R; Veith, F J; Sadek, M; Kashyap, V S; Maldonado, T S
Objective: Statins are often used for primary and secondary prevention of cardiovascular events. Multiple studies have demonstrated a significant reduction in perioperative complications after carotid endarterectomy for patients taking statins. However, data for statin use for patients undergoing transcarotid artery revascularization (TCAR) are limited. We evaluated the effects of statin use on the postoperative outcomes after TCAR.
Method(s): The records of the Vascular Quality Initiative carotid artery stenting registry (2012-2020) were reviewed for patients who had undergone TCAR. The patient demographics, perioperative characteristics, and 30-day outcomes were compared between the patients treated with and without statins (statin and no-statin group, respectively). Multivariable logistic regression models were used to estimate the effect of statins on the postoperative outcomes.
Result(s): A total of 15,797 patients had undergone TCAR, of whom, 10,116 (64%) were men. Of the 15,797 patients, 14,152 (89.6%) were taking a statin preoperatively (Table I). The statin group was more likely to have hypertension (91% vs 87%; P <.001), coronary artery disease (26% vs 23%; P =.008), and diabetes mellitus (33% vs 29%; P <.001). The incidence of both prior ipsilateral stroke (17.2% vs 13.5%; P <.001) and recent ipsilateral stroke (<=30 days; 7.1% vs 5.6%; P =.02) was higher in the statin group. No differences were found in the perioperative characteristics, including median operative time, contrast amount used, technical success, and number of stents used. Perioperative stroke and major adverse cardiac events (MACE; myocardial infarction, congestive heart failure, dysrhythmia) occurred in 1.5% and 2.4% of the statin group and 1.4% and 2.3% of the no-statin group, respectively. Controlling for covariates with the logistic regression method, statin use was associated with a 62% reduction in the odds of mortality (odds ratio, 0.38; 95% confidence interval, 0.19-0.99; P =.047; Table II) for patients who had experienced a perioperative stroke or MACE after TCAR.
Conclusion(s): Statin use was associated with a significant reduction in postoperative mortality for patients who had experienced a stroke or MACE after TCAR. Therefore, strict adherence to statin use is strongly recommended, especially for patients who could be at high risk of major postoperative complications. [Formula presented] [Formula presented]
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EMBASE:2014097723
ISSN: 1097-6809
CID: 5177152

The Degree of Carotid Artery Stenosis Affects the Perioperative Stroke Rate in Symptomatic Patients Undergoing Carotid Intervention [Meeting Abstract]

Garg, K; Jacobowitz, G R; Veith, F J; Patel, V I; Siracuse, J J; Maldonado, T S; Sadek, M; Cayne, N S; Rockman, C B
Objectives: In patients with carotid stenosis, both the severity of the stenosis as well as the plaque morphology influence the likelihood of future transient ischemic attack or stroke. In general, severely stenotic lesions are presumed to have a higher embolic potential than moderately stenotic lesions. Carotid intervention is indicated in patients with both moderate and severe stenosis with related cerebrovascular symptoms. However, the effect of the degree of carotid stenosis in symptomatic patients upon the outcome of carotid intervention has not been extensively studied.
Method(s): The Society for Vascular Surgery Quality Initiative database was queried for all patients undergoing transfemoral carotid stenting (CAS), carotid endarterectomy (CEA), and transcervical carotid stenting (TCAR) between 2003 and 2020. Patients undergoing interventions for symptomatic disease were included in the analysis. Patients were stratified into two cohorts based on the severity of stenosis-moderate (0%-69%) and severe (greater than or equal to 70%). Primary endpoints were perioperative neurologic events (strokes and transient ischemic attacks [TIAs]). Secondary endpoints were perioperative mortality and postoperative complications.
Result(s): Over 50,000 patients were included in the analysis: 5296 patients (8.9%) underwent TCAR, 7844 (13.3%) underwent CAS, and 45,853 (77.8%) underwent CEA for symptomatic carotid artery disease. In the TCAR and CEA cohorts, patients with moderate stenosis had a significantly higher rate of perioperative neurologic events than patients with severe stenosis (TCAR 4.3% vs 3.0%; P =.033; CEA 3.0% vs 2.3%; P <.001). In contrast, in patients undergoing CAS, there was no significant difference noted in the perioperative neurologic event rate (3.5% in moderate stenosis group vs 3.8% in severe stenosis group; P =.518). There were no differences in perioperative myocardial infarction or mortality (Table). On multivariable analysis, moderate stenosis was significantly and independently associated with an increased rate of neurologic events in the TCAR (odds ratio [OR], 0.833; 95% confidence interval, 0.693-1.000; P =.05), and CEA (odds ratio, 0.901; 95% confidence interval, 0.861-0.944; P <.001) cohorts.
Conclusion(s): Moderate carotid stenosis was associated with increased perioperative neurologic events in patients undergoing TCAR and CEA, but not CAS. Therefore, this effect was noted only in the cohorts that require direct open surgical manipulation of the cervical carotid artery (TCAR and CEA). Moderately stenotic lesions that become symptomatic likely have worse intrinsic plaque morphology than severely stenotic lesions, producing cerebrovascular symptoms at a lower degree of stenosis. The mechanism of such events warrants further evaluation with a particular focus on plaque morphology and brain physiology. [Formula presented]
Copyright
EMBASE:2014097884
ISSN: 1097-6809
CID: 5177322

Endothermal Heat Induced Thrombosis

Sadek, M; Kabnick, L S
Endothermal heat induced thrombosis (EHIT) is a post-procedural entity following endothermal superficial venous ablation that refers to the propagation of thrombus into the adjacent deep vein lumen. It is identified most commonly during the post-procedural surveillance venous duplex ultrasound. EHIT is recognized as a unique post-procedural entity, distinct in clinical behavior from a deep vein thrombosis. The definition, classification systems, pathophysiology, risk factors, treatment, and prevention are all discussed. The understanding of EHIT has advanced considerably, but additional data are required to understand its impact on quality of life and the cost-effectiveness of surveillance.
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EMBASE:635685664
ISSN: 2567-5826
CID: 4987302

Current status of endothermal heat induced thrombosis

Borsuk, Denis A; Sadek, Mikel; Kabnick, Lowell S
BACKGROUND:There remain many questions regarding the pathophysiology and risk factors for endothermal heat induced thrombosis formation. Moreover, there are a paucity of data on the timing of its occurrence, and there has been no consensus regarding for its treatment. The purpose of this review is to summarize the current knowledge on the pathophysiology, risk factors and treatment strategies for endothermal heat induced thrombosis. METHODS:The PubMed database was searched from 2001 to present for endothermal heat induced thrombosis, EHIT, deep vein thrombosis, chronic venous insufficiency, varicose veins, endovenous laser and radiofrequency ablation (treatment). All relevant articles identified by the authors mentioning endothermal heat induced thrombosis were included in this review. RESULTS:A multitude of risk factors, several pathophysiological hypotheses and different treatment strategies are described in the literature. CONCLUSIONS:Endothermal heat induced thrombosis is marginally understood. There remains a theoretical risk for significant venous thromboembolic complications. With the new uniform classification of EHIT (American Venous Forum), healthcare providers should continue to investigate the nature of this event.
PMID: 34008932
ISSN: 1827-1839
CID: 4877182

An algorithm combining VVSYmQ® and VCSS scores may help to predict disease severity in C2 patients

Sadek, Mikel; Pergamo, Matthew; Almeida, Jose I; Jacobowitz, Glenn R; Kabnick, Lowell S
OBJECTIVES/OBJECTIVE:The purpose was to assess whether combining patient reported scores (VVSymQ®) and physician reported scores (VCSS) stratifies disease severity in C2 patients. METHODS:Consecutive patients were pooled from the VANISH-1 and VANISH-2 cohorts. VCSS and VVSymQ® were calculated for each patient. The relationship between scoring systems was evaluated using Pearson's correlation and frequency distribution analysis. RESULTS:Two-hundred and ten C2 limbs were included. Scoring systems demonstrated: VVSymQ®: mean = 8.72; VCSS: mean = 6.32; correlation (r = 0.22, p = 0.05). Frequency distribution analysis demonstrated 61.4% of patients had low VVSymQ® and low VCSS; 31.3% had elevated VVSymQ® and increased VCSS; 7.3% were inconsistent with C2 disease. Strict concordance analysis revealed 40.5% had VVSymQ® (< 9)/VCSS (0-6), 18.6% had VVSymQ® (≥ 9)/VCSS (7-9), and 2.9% had VVSymQ® (≥9)/VCSS (≥10). CONCLUSIONS:For combined elevated VVSymQ® and VCSS, moderate/severe disease is corroborated, and intervention may be indicated. For combined lower scores, the disease severity is mild and conservative therapy is more appropriate.
PMID: 34121506
ISSN: 1758-1125
CID: 4907182

Assessment of Quality of Life Changes in Lower Extremity Lymphedema Patients Using an Advanced Pneumatic Compression Device at Home

Maldonado, Thomas S; Rokosh, Rae S; Padberg, Frank; Rotella, Vittorio; Miller, Hyman; Nassiri, Naiem; Jacobowitz, Glenn; Berland, Todd; Sadek, Mikel; Barfield, Michael E
OBJECTIVE:Lymphedema is associated with significant morbidity and healthcare resource usage. Conventional therapy efficacy is limited with poor surgical salvage options. Preliminary studies demonstrated advanced pneumatic compression devices (APCD) improve clinical outcomes, however limited evidence regarding their role in healthcare cost mitigation or health-related quality of life (QOL) is available. METHODS:) between February 2016 and March 2019. Patients were assessed at baseline, 12, 24, and 52 weeks from enrollment by limb circumference, QOL assessments (Short Form-36 [SF-36] and Lymphedema Quality of Life [LYMQOL]), device compliance, cellulitic episodes and lymphedema-related health care use since the previous visit. Primary endpoints of interest were QOL at baseline compared to 12 weeks as well as unscheduled lymphedema-related clinic visits and hospital admissions at 52 weeks. Secondary endpoints included change in limb girth and QOL at 52 weeks compared to baseline. RESULTS:178 patients with LE lymphedema were prospectively enrolled; this interim report represents the first 74 subjects to complete 52 weeks of APCD treatment. The cohort was predominately male (94.6%), elderly (mean 67 years), obese (median BMI 32), and most commonly enrolled for treatment of phlebolymphedema (71.6%) with largely bilateral LE involvement (91.9%). There was no significant difference in QOL at 12 weeks. However, at 52 weeks, LYMQOL was significantly improved from baseline (6.3 vs. 7.4, p<0.0001) and SF-36 demonstrated significant improvement from baseline in the Physical Component (38.6 vs. 40.8; p=0.035) with an effect towards overall improvement as well in the Mental Component (49.9 vs. 51.3; p=0.549). Limb circumference was significantly reduced at 12 weeks from baseline (28.5cm vs. 27.7cm; p=0.0005) in the most affected LE, and this reduction remained stable for the study duration. APCD treatment was associated with a significant reduction in cellulitic incidence (24.3% vs. 8.1%, p=0.005), lymphedema-related clinic visits (2.2 vs. 0.7; p=0.02), urgent care visits (1.2 vs. 0.3; p=0.004), and hospital admissions (0.5 vs. 0.1; p=0.047) per patient. CONCLUSIONS:The FLX APCD results in initial significant limb girth reduction as early as 12 weeks and a steady sustained improvement in health-related QOL up to one year. The latter is likely reflective of a decrease in cellulitis episodes and fewer associated lymphedema-related clinic, urgent care visits and hospital admissions.
PMID: 33137494
ISSN: 2213-3348
CID: 4664032

Deep Venous Thrombosis in Hospitalized Patients with Coronavirus Disease 2019

Chang, Heepeel; Rockman, Caron B; Jacobowitz, Glenn R; Speranza, Giancarlo; Johnson, William S; Horowitz, James M; Garg, Karan; Maldonado, Thomas S; Sadek, Mikel; Barfield, Michael E
OBJECTIVES/OBJECTIVE:The pandemic of Coronavirus disease 2019 (COVID-19) has caused devastating morbidity and mortality worldwide. In particular, thromboembolic complications have emerged as a key threat in COVID-19. We assessed our experience with deep venous thrombosis (DVT) in patients with COVID-19. METHODS:We performed a retrospective analysis of all patients with COVID-19 undergoing upper or lower extremity venous duplex ultrasonography at an academic health system in New York City between March 3 2020 and April 12 2020 with follow-up through May 12 2020. A cohort of hospitalized patients without COVID-19 (non-COVID-19) undergoing venous duplex ultrasonography from December 1 2019 to December 31 2019 was used for comparison. The primary outcome was DVT. Secondary outcomes included pulmonary embolism (PE), in-hospital mortality, admission to intensive care unit, and antithrombotic therapy. Multivariable logistic regression was performed to identify risk factors for DVT and mortality. RESULTS:Of 443 patients (188 COVID-19 and 255 non-COVID-19) undergoing venous duplex ultrasonography, patients with COVID-19 had higher incidence of DVT (31% vs. 19%; P=0.005), compared to the non-COVID-19 cohort. The incidence of PE was not statistically different between the COVID-19 and non-COVID-19 cohorts (8% vs. 4%; P=.105). The DVTs in the COVID-19 group were more distal (63% vs. 29%; P<.001) and bilateral (15% vs. 4%; P<.001). The result of duplex ultrasonography had a significant impact on the antithrombotic plan; 42 (72%) patients with COVID-19 in the DVT group had their therapies escalated while 49 (38%) and 3 (2%) patients had their therapies escalated and de-escalated in the non-DVT group, respectively (P<.001). Within the COVID-19 cohort, the D-dimer was significantly higher in the DVT group at the time of admission (2,746 ng/mL vs 1,481 ng/mL; P=.004) and at the time of the duplex exam (6,068 ng/mL vs. 3,049 ng/mL; P<0.01). At multivariable analysis, male sex (odd ratio (OR) 2.27; 95% confidence interval (CI), 1.06-4.87; P=.035), ICU admission (OR 3.42; 95% CI, 1.02-11.44; P=.046) and extracorporeal membrane oxygenation (OR 5.5; 95% CI, 1.01-30.13; P=.049) were independently associated with DVT. CONCLUSION/CONCLUSIONS:Given the high incidence of venous thromboembolic events in this population, we support the decision to empirically initiate therapeutic anticoagulation in patients with low bleeding risk and severe COVID-19 infection, with duplex ultrasonography reserved for patients with high clinical suspicion of VTE in which anticoagulation may pose a life-threatening consequence. Further study is warranted in patients with COVID-19 to elucidate the etiology of vascular thromboembolic events and guide prophylactic and therapeutic interventions in these patients.
PMCID:7543928
PMID: 33039545
ISSN: 2213-3348
CID: 4632272

Management of inferior vena cava thrombosis with the FlowTriever and ClotTriever systems

Shah, Noor G; Wible, Brandt C; Paulisin, Joseph A; Zaki, Mina; Lamparello, Patrick; Sista, Akhilesh; Sadek, Mikel; Jacobowitz, Glenn R; Maldonado, Thomas S
OBJECTIVE:Although inferior vena cava (IVC) thrombosis is infrequently encountered, it carries a significant risk of post-thrombotic syndrome and pulmonary embolus. Recent studies show no difference in the incidence of post-thrombotic syndrome in patients with iliofemoral deep venous thrombosis (DVT) treated with pharmacothrombolysis vs anticoagulation alone; however, there is an associated increased risk of bleeding. The treatment of IVC thrombosis is less well-studied and the hemodynamic changes may be more significant with pharmacothrombolysis, although the bleeding risk remains. The ClotTriever and FlowTriever systems remove thrombus from veins without the use of thrombolytics. Our study evaluates outcomes of patients undergoing mechanical thrombectomy for the treatment of IVC thrombosis using the ClotTriever and FlowTriever devices. METHODS:A retrospective chart review was performed to identify consecutive patients who underwent mechanical thrombectomy for the treatment of IVC thrombosis using the ClotTriever and/or FlowTriever systems from November 2018 to January 2020 at four data-sharing institutions. The decision of which device(s) to use was at the discretion of the surgeon. Patient demographics, symptomatology, and imaging characteristics were captured at presentation and follow-up. RESULTS:A total of 15 patients met the inclusion criteria; 10 were male, and the average age was 59 years. The majority of patients were symptomatic at presentation (n = 14), had a prior history of DVT (n = 13), and had a preexisting IVC filter (n = 8). Eleven patients presented with acute onset (<1 week) of symptoms, whereas three patients had subacute (1-4 weeks) symptoms. Most patients had an associated iliofemoral DVT (n = 13) and were treated with both ClotTriever and FlowTriever (n = 8); others were treated with either ClotTriever or FlowTriever alone (n = 5 and n = 2, respectively). Technical success was achieved in all but two patients, one who had a nonocclusive thrombus densely adherent to a preexisting IVC filter and another who had a chronic rubbery clot in the IVC that could not be cleared. No patient required concomitant lytic therapy or a postoperative stay in the intensive care unit. Furthermore, there were no postoperative bleeding events, myocardial infarctions, pulmonary emboli, renal impairments, or deaths. The median length of stay was 3 days (range, 1-37 days). Patients underwent postoperative follow-up (n = 7) as well as extended follow-up (>6 months; n = 8). All patients who achieved technical success were asymptomatic without evidence of reocclusion of the IVC on follow-up imaging. CONCLUSIONS:In our multicenter series of 15 patients, The ClotTriever and FlowTriever showed promise in the treatment of IVC thrombosis without the use of fibrinolytic drugs, with no bleeding events and no requirement for intensive care unit stay.
PMID: 33045392
ISSN: 2213-3348
CID: 4663452

Antegrade Superficial Femoral Artery Access for Lower Extremity Arterial Disease is Safe and Effective in the Outpatient Setting

Pezold, Michael; Blumberg, Sheila; Sadek, Mikel; Maldonado, Thomas; Cayne, Neal; Jacobowitz, Glenn; James, Herbert; Berland, Todd
INTRODUCTION/BACKGROUND:Antegrade superficial femoral artery (SFA) access for peripheral artery disease reduces the time, radiation and contrast required with contralateral common femoral access (CFA). Yet, this technique remains underutilized in the treatment of SFA, popliteal and tibial disease, and there remains limited data on the safety and effectiveness of antegrade SFA access in the outpatient setting. METHODS:A retrospective review of lower extremity peripheral arterial interventions in our office-based endovascular suite was conducted from 2013 to 2018. Interventions necessitating CFA access such as iliac, common femoral or deep femoral artery revascularization were excluded (n = 206). In addition, interventions potentially requiring large sheaths not amenable to SFA access (e.g. popliteal aneurysm) were excluded. Relevant demographic and treatment variables including postoperative complications were abstracted. RESULTS:We identified 718 patients, who underwent revascularization of the SFA, popliteal and tibial arteries. Antegrade SFA access was chosen in 448 patients (62.4%) with the remaining 270 patients having retrograde CFA access. Antegrade SFA access was achieved primarily with a 4 French sheath, while a majority of retrograde CFA interventions utilized a 6 French sheath for access (87.7% vs. 69.5%, p <0.001). Significantly less fluoroscopy (9.5 min vs 16.4 min, p <0.001) and contrast (25.4 mL vs. 38.5 mL, p <0.001) were used during SFA access compared with retrograde access. Technical success was achieved in 93.2% with antegrade SFA versus 94.8% retrograde CFA access (p 0.42). The overall rate of complications was low for both cohorts (2.7% vs. 3.7%, p 0.78) and there were no statistical differences in access-site complications (1.1% vs. 1.5%, p 0.94), hematoma (0.7% vs. 1.1%, p 0.84) and pseudoaneurysm (0.4% vs. 0%, p 0.98) between techniques. CONCLUSIONS:Percutaneous antegrade SFA access can be performed safely in the outpatient setting, and remains an effective alternative to retrograde CFA access with significantly less utilization of fluoroscopy and contrast.
PMID: 33271278
ISSN: 1615-5947
CID: 4694362