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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

Common iliac vein stenting for May-Thurner syndrome and subsequent pregnancy

Speranza, Giancarlo; Sadek, Mikel; Jacobowitz, Glenn
BACKGROUND:For women with left common iliac vein compression (ie, May-Thurner syndrome) who undergo venous stenting and subsequently become pregnant, concerns have been raised regarding a possible compromise of stent patency due to compression from the gravid uterus and the hypercoagulability induced by pregnancy. Only a small body of literature exists on this subject, and limited management guidelines are available. The present study was designed to evaluate the safety of iliac vein stenting for May-Thurner syndrome (MTS) with subsequent pregnancy. METHODS:Female patients who had undergone common iliac vein stenting at our center who were aged 18 to 45 years and had subsequently become pregnant were identified. A retrospective medical record review of eight eligible patients was conducted, recording the demographics, procedural characteristics, and anticoagulation strategies. The primary outcome evaluated was stent patency. RESULTS:All eight patients had undergone left common iliac vein stenting for MTS. A total of eight stents were placed, and all demonstrated duplex ultrasound patency throughout pregnancy and postpartum. Seven patients delivered healthy pregnancies, and one experienced a stillbirth. The clinical CEAP (clinical, etiologic, anatomic, pathophysiologic) class remained unchanged or improved from pregnancy to postpartum for all patients. The average age at stent placement was 31 ± 5 years, and the average interval from stent placement to pregnancy was 28 ± 19 months. One patient developed nonobstructive deep vein thrombosis (DVT) of the left femoral vein during pregnancy and was treated with therapeutic enoxaparin. The nonobstructive DVT did not compromise the iliac vein stent. Two patients received low-dose aspirin and prophylactic doses of enoxaparin, one for a history of DVT and factor V Leiden and one for a recent history of fertility treatment. The five remaining patients received no anticoagulation, three received low-dose aspirin, and two received no antiplatelet therapy. CONCLUSIONS:Common iliac vein stent patency was not compromised by subsequent pregnancy in our eight patients with MTS. Furthermore, the stents remained patent throughout pregnancy in patients receiving a wide range of anticoagulation and antiplatelet treatments, suggesting that no uniform therapeutic threshold exists and treatment should be individualized. For most patients, low-dose aspirin alone or no treatment was adequate. This could have implications for counseling women who require intervention for MTS and are of child-bearing age.
PMID: 34438090
ISSN: 2213-3348
CID: 5011602

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.
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

The Presence of a Pathologic Perforator May be Predictive of Central Venous Pathology and Multilevel Disease in Severe Chronic Venous Insufficiency

Li, Chong; Nwachukwu, Chukwuma; Jacobowitz, Glenn R; Kabnick, Lowell S; Maldonado, Thomas S; Rockman, Caron B; Berland, Todd L; Sadek, Mikel
INTRODUCTION/BACKGROUND:The treatment of a refluxing perforator is indicated in the setting of severe chronic venous insufficiency, but there are limited data on the presence of multilevel disease in these patients. This study sought to evaluate whether the presence of a pathologic perforator is predictive of the presence of central venous pathology. METHODS:This study was a retrospective review of the institutional vascular quality initiative (VQI) database. Consecutive patient-limbs were identified who underwent intervention of refluxing perforators. The patients who underwent imaging, including MRI or CT (Group A) were compared to those who did not undergo imaging (Group B). The treated limbs in Group A were also compared to the contralateral limbs as an internal control. Anatomical findings on imaging were analyzed by two independent investigators. The primary outcome was the presence and degree of central venous stenosis as measured by an orthogonal diameter reduction of > 50% by axial imaging. Secondary outcomes included demographic and clinical differences between the two groups, frequency of central venous intervention, and duration of ulcer healing. Standard statistical analysis was performed. RESULTS:Ninety-three patient-limbs underwent treatment of a pathologic perforator, with 30 in Group A and 63 in Group B. The following demographic and clinical variables were higher in Group A compared to Group B: Male gender, BMI, deep venous thrombosis history, recent or active anticoagulation use, perforator diameter, Clinical Etiology Anatomy Pathophysiology class 4, 5 or 6, and Venous Clinical Severity Score. Radiographic analysis of Group A revealed concordance of a treated pathological perforator with an ipsilateral central venous stenosis in 53.3% of patients, and a higher frequency of common iliac vein stenosis (50% vs 21.4%, P = 0.024) and external iliac vein stenosis (20% vs 0%, P = 0.012) compared to the contralateral limbs. When separated by left or right limb, the left limbs exhibited a greater degree of common iliac vein stenosis as compared to the contralateral limbs (50.7±20.9% vs 16.3±16.5%, P < 0.001) as well as a greater frequency of >50% common iliac vein stenosis (46.7% vs 13.3%, P = 0.046). The right limbs exhibited a greater frequency of > 50% external iliac vein stenosis as compared to contralateral limbs (33.3% vs 0%, P = 0.022). CONCLUSIONS:This study suggests that patients with severe chronic venous insufficiency who undergo treatment for a pathologic perforator may have additional ipsilateral central venous pathology, supporting the presence of multilevel disease. Additional axial imaging might unmask central venous pathology and provide another option for treatment.
PMID: 34252577
ISSN: 2213-3348
CID: 4938302

Review of the Current Evidence for Topical Treatment for Venous Leg Ulcers

Shaydakov, Maxim E; Ting, Windsor; Sadek, Mikel; Aziz, Faisal; Diaz, Jose A; Raffetto, Joseph D; Marston, William A; Lal, Brajesh K; Welch, Harold J
OBJECTIVE:The development of a venous leg ulcer (VLU) represents the most severe clinical manifestation of a chronic venous disease. Despite major progress, there is a limited understanding of VLU pathogenesis and wound healing biology. Treatment of VLUs remains a serious challenge for physicians of different specialties. This communication focuses on describing the rationale and scientific basis for topical wound care in the management of VLUs. METHODS:A literature review was performed to summarize methods with proven efficacy in VLU management. A systematic literature search was also performed to identify new evidence from the randomized controlled trials published within 2014-2021. The scientific challenges, clinical practice concerns, economic obstacles, and possible directions for further research have been discussed. RESULTS:Hundreds of topical products have been advertised for the treatment of VLUs. Published data on topical treatment of venous ulcers is insufficient, scattered, weak, and has significant methodological flaws. Forty-three randomized controlled trials on topical treatment of VLUs have been published within 2014-2021. Clinical practice guidelines need to be updated. Major gaps in knowledge have been identified, and suggestions for future research directions have been provided. CONCLUSIONS:The American Venous Forum Research Committee would like to bring attention to topical wound care for VLUs as a critical gap in knowledge, and encourage scientists, practitioners, and industry to collaborate to fill this gap.
PMID: 34171531
ISSN: 2213-3348
CID: 4925852

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.
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