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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
Increased Risk of Major Limb Events in Poor Clopidogrel Responders: Platelet Activity in Vascular Surgery and Cardiovascular Events (PACE) Study Subgroup Analysis [Meeting Abstract]
Tawil, M; Berger, J; Lamparello, P; Jacobowitz, G; Cayne, N; Sadek, M; Berland, T; Lugo, J; Rockman, C; Maldonado, T
Objective: Whereas clopidogrel is effective at decreasing cardiovascular events in patients with peripheral artery disease, a substantial number of events continue to occur. This study investigated the variability in response to clopidogrel and its relationship with clinical outcomes.
Method(s): There were 300 patients enrolled in the Platelet Activity in Vascular Surgery and Cardiovascular Events (PACE) study before lower extremity revascularization, of whom 119 were receiving clopidogrel. Platelet aggregation was measured in response to adenosine diphosphate (ADP) 2M immediately before revascularization. Patients were observed longitudinally for a median follow-up of 18 months. The primary end point was major adverse limb events (MALEs), defined by major amputation or reoperation of the affected limb. Patients were stratified into groups according to the percentage ADP-induced aggregation at 300 seconds (<50% aggregation, normal responder; >=50% aggregation, poor responder).
Result(s): Overall, the median age was 70 years (62-76 years), and 39.5% were female. Thirty-six (30.3%) patients had a MALE event (15 major amputation and 25 major reoperation); 60 patients underwent open or hybrid operations, and 50 patients underwent endovascular procedures. The remaining nine patients had no interventions. Of the group of 119 patients, 97 patients were taking aspirin. Overall, median aggregation to ADP 2M was 22.5% (Q1-Q3, 10%-50%), and 27 patients (26%) were clopidogrel nonresponders. Baseline aggregation was higher in patients who went on to develop a MALE than in those without a MALE (43% vs 20%; P =.018). Patients with aggregation > median (22.5%) were more likely to experience a MALE than were patients with aggregation < median (69% vs 31%; hazard ratio [HR], 2.71; 95% confidence interval [CI], 1.23-5.98; P =.013). After multivariable adjustment for age, sex, race/ethnicity, body mass index, diabetes, coronary artery disease, and aspirin, aggregation > median was associated with MALEs (adjusted HR, 2.67; 95% CI, 1.18-6.01; P =.018). When stratified by established cutoffs for responsiveness to clopidogrel (50% aggregation), 27 (26%) patients were poor responders. Poor responders were more likely to experience MALEs than normal responders (59% vs 41%; HR, 2.33; 95% CI, 1.11-4.89; P =.026). After multivariable adjustment, poor responder status trended toward an increased risk of MALE compared with a normal responder (adjusted HR, 2.18; 95% CI, 1.00-4.78; P =.051).
Conclusion(s): Among patients undergoing lower extremity revascularization, poor response to clopidogrel is associated with increased risk for major adverse limb events. Preoperative screening to ensure therapeutic clopidogrel response should be considered in these patients.
Copyright
EMBASE:2008357484
ISSN: 1097-6809
CID: 5184272
Classification and treatment of endothermal heat-induced thrombosis: Recommendations from the American Venous Forum and the Society for Vascular Surgery This Practice Guidelines document has been co-published in Phlebology [DOI: 10.1177/0268355520953759] and Journal of Vascular Surgery: Venous and Lymphatic Disorders [DOI: 10.1016/j.jvsv.2020.06.008]. The publications are identical except for minor stylistic and spelling differences in keeping with each journal's style. The contribution has been published under a Attribution-Non Commercial-No Derivatives 4.0 International (CC BY-NC-ND 4.0), (https://creativecommons.org/licenses/by-nc-nd/4.0/)
Kabnick, Lowell S; Sadek, Mikel; Bjarnason, Haraldur; Coleman, Dawn M; Dillavou, Ellen D; Hingorani, Anil P; Lal, Brajesh K; Lawrence, Peter F; Malgor, Rafael; 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: 32998622
ISSN: 1758-1125
CID: 4616982
Arterial thromboembolism associated with COVID-19 and elevated D-dimer levels [Case Report]
Garg, Karan; Barfield, Michael E; Pezold, Michael L; Sadek, Mikel; Cayne, Neal S; Lugo, Joanelle; Maldonado, Thomas S; Berland, Todd L; Rockman, Caron B; Jacobowitz, Glenn R
The novel coronavirus 2019 (SARS-CoV-2) was first identified in January 2020 and has since evolved into a pandemic affecting >200 countries. The severity of presentation is variable and carries a mortality between 1% and 3%. We continue to learn about the virus and the resulting acute respiratory illness and hypercoagulability; however, much remains unknown. In our early experience in a high-volume center, we report a series of four cases of acute peripheral artery ischemia in patients with COVID-19 in the setting of elevated D-dimer levels.
PMCID:7297695
PMID: 32704579
ISSN: 2468-4287
CID: 4539752
In Well-Selected Patients With a Femoral Deep Vein Thrombosis Central Venous Imaging May Identify Additional Iliocaval Disease
Li, Chong; Maldonado, Thomas S; Jacobowitz, Glenn R; Kabnick, Lowell S; Barfield, Michael; Rockman, Caron B; Berland, Todd L; Cayne, Neal S; Sadek, Mikel
OBJECTIVE/UNASSIGNED:Patients who present acutely with a femoral deep vein thrombosis (DVT) diagnosed by ultrasound are often treated with anticoagulation and instructed to follow-up electively. This study sought to assess whether obtaining axial imaging of the central venous system results in the identification of additional iliocaval pathology warranting treatment. METHODS/UNASSIGNED:This study was a retrospective review of a prospectively maintained registry from November 2014 through April 2017 with follow-up through March 2020. Consecutive patients with a diagnosis of femoral DVT diagnosed by ultrasound were evaluated; those who underwent axial imaging of the iliocaval system (Group A) were compared to those who did not undergo imaging of the central veins (Group B). The primary outcome was the performance of any percutaneous central venous intervention. Secondary outcomes included the extent of DVT identified on duplex and after axial imaging, follow-up duplex patency and persistence of severe symptoms. RESULTS/UNASSIGNED:Eighty patients presented with an ultrasound diagnosis of a femoral vein DVT. Mean follow-up was 551 ± 502 days. Group A comprised 24 patients (30%) and Group B comprised 56 patients (70%). Baseline demographics did not differ significantly between the 2 groups. After duplex imaging, Group A exhibited an increased prevalence of DVT in the common femoral vein. After central imaging, Group A exhibited an increased prevalence of DVT in the iliocaval veins. The number of patients who underwent invasive treatment differed significantly between the 2 groups, Group A 16/24 (67%) vs. Group B 9/56 (16%), P < 0.0001. The number of patients that demonstrated duplex patency and had persistent symptoms on follow-up did not differ significantly. CONCLUSIONS/UNASSIGNED:Patients with an ultrasound diagnosis of femoral DVT may have additional iliocaval pathology warranting intervention. Well-selected imaging of the central veins may reveal a more complete picture, potentially altering management.
PMID: 32744182
ISSN: 1938-9116
CID: 4553682