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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

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

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

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

Iliofemoral Venous Stenting May Contribute to Improving Femoropopliteal Deep Vein Reflux [Meeting Abstract]

Pergamo, M; Kabnick, L; Jacobowitz, G; Rockman, C; Maldonado, T; Berland, T; Blumberg, S; Sadek, M
Background: Severe presentations of chronic venous insufficiency may result from reflux or obstruction at the deep venous, perforator or superficial venous levels. Iliofemoral venous stenting may be used to address central venous obstruction, but its effect on deep venous reflux remains unclear. The purpose of this study was to evaluate the effect of iliac vein stenting on femoropopliteal deep vein reflux with the hypothesis that sonographic evidence of deep vein reflux would remain absent or improve following iliac vein stenting.
Method(s): This study was a retrospective review of patients undergoing iliofemoral venous stenting from 2013-2020. Patients were divided into two cohorts based on the preprocedural presence (Group A) or absence (Group B) of femoropopliteal reflux. Baseline patient variables were collected including age, gender, CEAP, presence of concomitant superficial or perforator reflux, DVT history, and additional venous intervention(s). The primary outcome evaluated was the persistent absence or the resolution of deep vein reflux on the latest venous duplex ultrasound follow-up. Other outcomes included follow-up CEAP classification as well as need for secondary deep venous interventions.
Result(s): There were 275 consecutive patients who underwent iliofemoral venous stenting. Of those, 58 presented with deep vein reflux (Group A), and the remaining did not (Group B). When comparing Group A and Group B, patients in Group A had a higher likelihood of prior DVT (P =.0001) as well as higher frequency of venous ablation (Table). The remaining demographics did not differ significantly between the two groups. In Group A, deep vein reflux resolved in follow-up in 17/51 patients (P =.0001). In Group B, deep vein reflux developed on follow-up in 6/217 patients. CEAP appeared to improve from preintervention (C0, 1.1%; C1, 0.4%; C2, 1.8%; C3, 41.4%; C4, 24.9%; C5, 5.9%; and C6, 24.5%) to latest follow-up (C0, 4.9%; C1, 1.9%; C2, 5.7%; C3, 34.2%; C4, 22.8%; C5, 17.1%; and C6, 13.3%).
Conclusion(s): For patients who undergo iliofemoral vein stenting, deep vein reflux may improve if present initially, and is unlikely to develop if not present prior to intervention. A cohort of patients maintained persistent deep vein reflux, and these warrant further evaluation. Prospective studies are required to corroborate the safety, efficacy and durability of iliofemoral venous stenting in patients with deep vein reflux. [Formula presented]
Copyright
EMBASE:2010941746
ISSN: 2213-3348
CID: 5184222

Closed Incision Negative Pressure Wound Therapy May Decrease Wound Complications in Major Lower Extremity Amputations

Chang, Heepeel; Maldonado, Thomas S; Rockman, Caron B; Cayne, Neal S; Berland, Todd L; Barfield, Michael E; Jacobowitz, Glenn R; Sadek, Mikel
OBJECTIVE:Wound complications after major lower extremity amputations are a cause of significant morbidity in vascular surgery patients. Recent publications have demonstrated the efficacy of the closed incision negative pressure dressing at preventing surgical site infections (SSIs); however, there are limited data on its use in major lower extremity amputations. This study sought to assess if closed incision negative pressure wound therapy (NPWT) would reduce the risk of complications as compared to a standard dressing in patients with peripheral vascular disease undergoing major lower extremity amputation. METHODS:system (Acelity L.P. Inc., San Antonio, TX, USA) was applied intraoperatively at the discretion of the operating surgeon and removed 5 to 7 days postoperatively. The standard group received a non-adherent dressing with an overlying compression dressing. Amputation incisions were assessed and wound complications were recorded. Student's t-test and two-sample proportion z-test were used for statistical analysis. A P value < .05 was considered statistically significant. RESULTS:For comorbidities, there was a higher incidence of tobacco use in the NPWT as compared to the standard group (44% vs. 13%; P = .011), as well as trends towards increased prior amputations, anemia, hyperlipidemia, and chronic obstructive pulmonary disorder in the NPWT group. For risk factors, there were more dirty wounds in the NPWT as compared to the standard group (52% vs. 26%; P = .046). For outcomes, there were fewer wound complications in the NPWT as compared to the standard group (13% vs. 39%; P = .037). The types of wound-related complications in the NPWT group included one wound dehiscence with a deep SSI, one superficial SSI and one incision line necrosis. In the standard group, there were 4 wound dehiscences with deep SSI, 3 superficial SSIs, 4 incision line necroses and 1 stump hematoma. The rates of perioperative mortality and amputation revision did not differ significantly between the NPWT and the standard group (3% vs. 4% and 4.3% vs. 10%, respectively). CONCLUSIONS:Closed incision negative pressure wound therapy may decrease the incidence of wound complications in vascular patients undergoing major lower extremity amputation. This held true even amongst a population that was potentially at higher risk. This therapy may be considered for use in lower extremity major amputations.
PMID: 32707380
ISSN: 1097-6809
CID: 4539842

Classification and treatment of endothermal heat-induced thrombosis: Recommendations from the American Venous Forum and the Society for Vascular Surgery

Kabnick, Lowell S; Sadek, Mikel; Bjarnason, Haraldur; Coleman, Dawn M; Dillavou, Ellen D; Hingorani, Anil P; Lal, Brajesh K; Lawrence, Peter F; Malgor, Rafael D; Puggioni, Alessandra
The American Venous Forum (AVF) and the Society for Vascular Surgery set forth these guidelines for the management of endothermal heat-induced thrombosis (EHIT). The guidelines serve to compile the body of literature on EHIT and to put forth evidence-based recommendations. The guidelines are divided into the following categories: classification of EHIT, risk factors and prevention, and treatment of EHIT. One major feature is to standardize the reporting under one classification system. The Kabnick and Lawrence classification systems are now combined into the AVF EHIT classification system. The novel classification system affords standardization in reporting but also allows continued combined evaluation with the current body of literature. Recommendations codify the use of duplex ultrasound for the diagnosis of EHIT. Risk factor assessments and methods of prevention including mechanical prophylaxis, chemical prophylaxis, and ablation distance are discussed. Treatment guidelines are tailored to the AVF EHIT class (ie, I, II, III, IV). Reference is made to the use of surveillance, antiplatelet therapy, and anticoagulants as deemed indicated, and the recommendations incorporate the use of the novel direct oral anticoagulants. Last, EHIT management as it relates to the great and small saphenous veins is discussed.
PMID: 33012690
ISSN: 2213-3348
CID: 4626572

Increased Aortic Sac Regression and Decreased Infrarenal Aortic Neck Dilation After Fenestrated Endovascular Aneurysm Repair Compared With Standard Endovascular Aneurysm Repair [Meeting Abstract]

Li, C; Teter, K; Rockman, C; Garg, K; Cayne, N; Veith, F; Sadek, M; Maldonado, T
Objective: Aortic neck dilation (AND) can occur in nearly 25% of patients after EVAR, resulting in loss of proximal seal and aortic rupture. Fenestrated endovascular aneurysm repair (FEVAR) affords increased treatment options for patients with shorter infrarenal aortic necks; however, AND has not been well characterized in these patients. This study sought to compare AND in patients undergoing FEVAR vs standard endovascular aneurysm repair (EVAR).
Method(s): Retrospective review was conducted of prospectively collected data of 20 consecutive FEVAR patients (Cook Zenith fenestrated; Cook Medical, Bloomington, Ind) and 20 EVAR patients (Cook Zenith). Demographic and anatomic characteristics, procedural details, and clinical outcome were analyzed. Preoperative, 1-month postoperative, and longest follow-up computed tomography scans were analyzed using a dedicated three-dimensional workstation. Abdominal aortic aneurysm (AAA) neck diameter was measured in 5-mm increments from the lowest renal artery. Standard statistical analysis was performed.
Result(s): Demographic characteristics did not differ significantly between the two cohorts. The FEVAR group had larger mean aortic diameter at the lowest renal artery, shorter infrarenal aortic neck length, increased prevalence of nonparallel neck shape, and longer AAA length (Table). On follow-up imaging, the suprarenal aortic segment dilated significantly more at all suprarenal locations in the FEVAR cohort, whereas the infrarenal aortic neck segment dilated significantly less compared with the EVAR group (Table). The FEVAR group demonstrated significantly greater sac regression vs the EVAR group. Positive aortic remodeling, as evidenced by increased distance from the celiac axis to the most cephalad margin of the AAA, occurred to a more significant degree in the FEVAR cohort. Device migration, endoleak occurrence, and need for reintervention were similar in both groups.
Conclusion(s): Compared with EVAR, patients undergoing FEVAR had greater extent of suprarenal AND, consistent with a more diseased native proximal aorta. However, the infrarenal neck, which is shorter and also more diseased in FEVAR patients, appears more stable in the postoperative period compared with EVAR cases. Moreover, the FEVAR cohort had significantly greater sac shrinkage and improved aortic remodeling. The suprarenal seal zone in FEVAR may confer a previously undescribed increased level of protection against infrarenal neck dilation and lessen endotension, resulting in more rapid and dramatic sac shrinkage and contributing to a more durable aortic repair. [Formula presented]
Copyright
EMBASE:2008357459
ISSN: 1097-6809
CID: 5184292