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A prospective safety and effectiveness study using endovenous laser ablation with a 400-μm optical fiber for the treatment of pathologic perforator veins in patients with advanced venous disease (SeCure trial)

Gibson, Kathleen; Elias, Steven; Adelman, Mark; Hager, Eric S; Dexter, David J; Vayuvegula, Sathish; Chopra, Paramjit; Kabnick, Lowell S
BACKGROUND:Treatment of pathologic perforator veins (PPVs) can shorten time to healing and reduce recurrence of ulcers in patients with advanced venous disease. Because of limited clinical evidence and device options, widespread adoption of PPV treatment is controversial. The objective of this study was to evaluate the safety and efficacy of endovenous laser therapy using a 400-μm optical fiber to treat PPVs. METHODS:This study was a single-arm, prospective, seven-center, nonblinded clinical study examining patients with advanced skin changes or healed or active ulceration (Clinical, Etiology, Anatomy, and Pathophysiology clinical class C4b, C5, and C6). Patients received treatment with a 1470-nm laser. Procedural technical success and 10-day primary closure were evaluated. All device-related adverse events were reported. Follow-up of patients was continued for 12 months after initial ablation. RESULTS:The primary PPV closure (at 10-day visit) rate was 76.9% (95% confidence interval, 70.3%-82.4%). Successful primary closure rates of 75.7%, 70.3%, 62.1%, 68.8%, and 71.3% of PPVs were achieved at 1 month, 3 months, 6 months, 9 months, and 12 months, respectively. Statistically significant improvements (P < .05) were seen in patients' quality of life at 1 month, 3 months, 6 months, 9 months, and 12 months compared with screening. The percentage of patients with ulcers (22.9% at screening, 14.1% at 1 month, 13.7% at 3 months, 10.1% at 6 months, 12.3% at 9 months, and 11.1% at 12 months) displayed improvement during the course of the study. Tibial deep venous thrombosis and procedural pain were the only device-related adverse events observed. CONCLUSIONS:Endovenous laser therapy for PPV using the 400-μm optical fiber with the 1470-nm laser yielded safe and effective outcomes with no major adverse sequelae.
PMID: 32205128
ISSN: 2213-3348
CID: 4357652

Presentation and Management of Inferior Vena Cava Thrombosis

Teter, Katherine; Schrem, Ezra; Ranganath, Neel; Adelman, Mark; Berger, Jeffrey; Sussman, Rebecca; Ramkhelawon, Bhama; Rockman, Caron; Maldonado, Thomas S
BACKGROUND:Inferior vena cava thrombosis (IVCT), although rare, has a potential for significant morbidity and mortality. IVCT is often a result of IVC filter thrombosis, but it can also occur de novo. Although anticoagulation remains the standard of care, endovascular techniques to restore IVC patency have become key adjunctive therapies in recent years. This study examines a single-center experience with diagnosis and management of IVCT. METHODS:A retrospective Institutional Review Board-approved review of a single-center institutional database was screened to identify IVCT thrombosis using International Classification of Diseases code 453.2 over a 3-year period. Etiology of IVCT was separated into 2 groups: those with IVC thrombosis in the setting of prior IVC filter place and those in whom IVCT occurred de novo. Patient demographics, presenting characteristics, and management of IVCT were examined. Treatment options included expectant management with anticoagulation versus catheter-directed thrombolysis (CDT), mechanical thrombectomy, stenting, or a combination. For those who underwent intervention, technical success, defined as restoration of IVC patency, was assessed. RESULTS:Forty-one unique patients were identified with radiographically confirmed diagnosis of ICVT (mean age 61, range 25-91; 21 female, 51.2%). Eighteen (43.9%) patients presented with thrombosed IVC filter. Risk factors for venous thromboembolism included tobacco usage, current or prior smoking (n = 17, 41.5%), history of prior deep vein thrombosis (n = 25, 61.0%), malignancy (n = 17, 41.5%), use of hormonal supplements (n = 3, 7.3%), known thrombophilia (n = 4, 9.8%), and obesity (body mass index: mean 29, range 18.8-58.53). Eleven patients (26.8%) presented with pulmonary embolism (PE), and of those 63.6% had IVC filter thrombosis (n = 7). Risk of PE was not significantly different between those patients presenting with a thrombosed IVC filter compared to those with de novo IVCT (38.9% vs. 17.4%, P = 0.12) Management of IVCT included anticoagulation alone (n = 27, 65.9%), CDT (n = 5, 12.2%), mechanical thrombolysis (n = 10, 24.4%), and adjunctive IVC stent (n = 3, 7.3%). Among the 14 (34.1%) patients who had intervention for IVCT, patency was restored in 12 patients (85.7%). CONCLUSIONS:IVCT is a rare event and is associated with known risk factors for venous thromboembolism. PE can occur in roughly 25% of patients presenting with IVCT. Presence of a filter does not appear to confer an advantage in preventing PE when IVCT occurs. Although majority of IVCT is managed with anticoagulation alone, endovascular interventions, including lysis and stenting, can safely restore patency in most properly selected patients.
PMID: 30982504
ISSN: 1615-5947
CID: 3807542

Practice Patterns of Fenestrated Aortic Aneurysm Repair: Nationwide Comparison of Z-Fen Adoption at Academic and Community Centers Since Commercial Availability

Wiske, Clay; Lee, Jason T; Rockman, Caron; Veith, Frank J; Cayne, Neal; Adelman, Mark; Maldonado, Thomas
CONTEXT/BACKGROUND:Over the past decade, a number of endovascular approaches have evolved to treat aortic aneurysms with anatomy that is not amenable to traditional endovascular repair, although the optimal practice and referral patterns remain in question. The Zenith fenestrated (Z-Fen) endograft (Cook Medical) represents the first commercially available fenestrated graft product in the United States. OBJECTIVE:We aim to quantify practice patterns in Z-Fen use during the first 5 years of commercial availability, and we identify predictors of high and low uptake. DESIGN, SETTING, AND PATIENTS/METHODS:This is a retrospective review of complete order records for Z-Fen endografts since June 2012. We performed univariate and multivariate regressions of predictors that surgeons and centers would be in the top and bottom quartiles of annual Z-Fen use. RESULTS:Since June 15, 2012, 744 surgeons have been trained to use Z-Fen, and 4133 cases have been performed at 409 trained centers. The average annual number of cases per trained surgeon was 4.46 [95% confidence interval (CI), 3.58-5.70]; however, many surgeons performed few or no cases following training, and there was a skew toward users with low average annual volumes (25th percentile 1.23, 50th percentile 2.35, 75th percentile 4.93, and 99th percentile 33.29). Predictors of high annual use in the years following training included academic center (aOR 5.87, P = .001) and training within the first 2 years of availability (aOR 46.23, P < .001). CONCLUSION/CONCLUSIONS:While there is literature supporting the safety and efficacy of Z-Fen, adoption has been relatively slow in an era when the vast majority of vascular surgeons have advanced endovascular skills. Given the training and resources required to use fenestrated or branched aortic endovascular devices, referral patterns should be determined and training should be focused on centers with high expected volumes.
PMID: 29843567
ISSN: 1938-9116
CID: 3136882

A systematic review of venous aneurysms by anatomic location

Teter, Katherine A; Maldonado, Thomas M; Adelman, Mark A
OBJECTIVE:Venous aneurysms are uncommon vascular abnormalities that may be identified anywhere in the body. Historically, they were often misdiagnosed as soft tissue lesions, but with the advent of readily available noninvasive imaging (such as duplex ultrasound), they can now be easily identified. Our aim was to review the presentation of venous aneurysms, available imaging modalities for defining them, and management. METHODS:The English-language literature before March 2017 was reviewed, and only reports of primary venous aneurysms of the deep veins were included. Reports were subdivided on the basis of the location of the venous aneurysm, and reports containing sample imaging studies were referenced from Elsevier publications. RESULTS:In total, our review identified reports of 35 head and neck venous aneurysms, 42 thoracic venous aneurysms, 152 intra-abdominal venous aneurysms, and 279 venous aneurysms of the extremities. Venous aneurysms of the lower extremity deep veins were most likely to be manifested by venous thromboembolic events, with approximately 25% to 50% of popliteal vein aneurysms presenting with pulmonary embolism. Diagnosis can be made by duplex ultrasound, computed tomography venography, magnetic resonance venography, or invasive venography. Management varies by location; most thoracic and head and neck aneurysms are observed, whereas venous aneurysms of the extremities are treated with surgical intervention, given the potential for venous thromboembolism. Few reports describe endovascular management of these lesions, so open surgical intervention remains the standard of care. CONCLUSIONS:Venous aneurysms are rare vascular malformations that occur throughout the body. Many are identified on routine imaging ordered for other indications, whereas venous aneurysms of the deep veins of the extremities are often manifested with venous thromboembolism. Management of these lesions is determined largely by location and the potential morbidity and mortality of the untreated aneurysms vs surgery; aneurysms of the head and neck and thorax are managed with observation and serial imaging over time, whereas those of the abdomen and extremities are treated with surgical intervention. Endovascular techniques continue to lack a defined role in their management, and the standard of care remains open repair, when indicated.
PMID: 29661366
ISSN: 2213-3348
CID: 3042682

Clinical significance of reversal of flow in the vertebral artery identified on cerebrovascular duplex ultrasound

Policha, Aleksandra; Baldwin, Melissa; Lee, Victoria; Adelman, Mark A; Rockman, Caron; Berland, Todd; Cayne, Neal S; Maldonado, Thomas S
BACKGROUND: Reversal of flow in the vertebral artery (RFVA) is an uncommon finding on cerebrovascular duplex ultrasound examination. The clinical significance of RFVA and the natural history of patients presenting with it are poorly understood. Our objective was to better characterize the symptoms and outcomes of patients presenting with RFVA. METHODS: A retrospective review was performed of all cerebrovascular duplex ultrasound studies performed at our institution between January 2010 and January 2016 (N = 2927 patients). Individuals with RFVA in one or both vertebral arteries were included in the analysis. RESULTS: Seventy-four patients (74/2927 patients [2.5%]) with RFVA were identified. Half of the patients were male. Mean age at the time of the first ultrasound study demonstrating RFVA was 71 years (range, 27-92 years); 78% of patients had hypertension, 28% were diabetic, and 66% were current or former smokers. Indications for the ultrasound examination were as follows: 44% screening/asymptomatic, 7% anterior circulation symptoms, 20% posterior circulation symptoms, 28% follow-up studies after cerebrovascular intervention, and 5% upper extremity symptoms. At the time of the initial ultrasound examination, 21 patients (28%) had evidence of a prior carotid intervention (carotid endarterectomy or carotid stenting), 21 patients had evidence of moderate (50%-79%) carotid artery stenosis (CAS) in at least one carotid artery, and 12 patients (16%) had evidence of severe (>80%) CAS. Of the 15 patients presenting with posterior circulation symptoms, 11 (73%) had evidence of concomitant CAS. In contrast, 22 of the 59 patients (37%) without posterior circulation symptoms had duplex ultrasound findings of CAS (P = .01). The mean duration of follow-up was 28 +/- 22 months. Follow-up data were available for 63 patients (85%), including the 15 patients who presented with posterior circulation symptoms. Of these 15 patients, 5 underwent subclavian artery revascularization, including balloon angioplasty and stenting in 4 patients and open/hybrid revascularization in 1 patient. Five individuals were awaiting intervention. Three patients underwent carotid endarterectomy for CAS, with resultant improvement in posterior circulation symptoms. Finally, one patient was deemed too high risk for intervention, and one patient was found to have an alternative cause for symptoms. The remaining 59 patients continued to be asymptomatic during follow-up. One patient progressed to vertebral artery occlusion, and six patients had progression of CAS. CONCLUSIONS: Symptomatic RFVA responds well to intervention, including subclavian artery stenting and carotid intervention in patients with CAS. The majority of patients with this finding are asymptomatic at the time of presentation. Although progression of vertebral artery disease is rare, these patients may benefit from monitoring for progression of CAS with surveillance ultrasound.
PMID: 28935292
ISSN: 1097-6809
CID: 2708622

Greater Frequency of Fruit and Vegetable Consumption Is Associated With Lower Prevalence of Peripheral Artery Disease

Heffron, Sean P; Rockman, Caron B; Adelman, Mark A; Gianos, Eugenia; Guo, Yu; Xu, Jin Feng; Berger, Jeffrey S
OBJECTIVE: Although fruit and vegetable (F&V) consumption is associated with lower risk of coronary heart disease and stroke, its association with peripheral artery disease (PAD) is less certain. We, thus, sought to characterize F&V intake and investigate the association between F&V consumption and presence of PAD in a large community sample. APPROACH AND RESULTS: Self-referred participants at >20 000 US sites who completed medical and lifestyle questionnaires were evaluated by screening ankle brachial indices for PAD (ankle brachial index /=3 servings of F&V was reported by 29.2%. Increasing age, female sex, white race, never smoking, being currently married, physical activity, increasing income, and frequent consumption of fish, nuts, and red meat were positively associated with daily consumption of F&V. After multivariable adjustment, there was a stepwise inverse association between F&V intake and PAD. Participants reporting daily intake of >/=3 servings of F&V had 18% lower odds of PAD than those reporting less than monthly consumption. In unadjusted and multivariable-adjusted models, the inverse association with F&V became stronger as ankle brachial index decreased. When stratified by smoking status, the association was present only among those subjects who currently or formerly smoked tobacco. CONCLUSIONS: Our study demonstrates an inverse association of F&V consumption with prevalent PAD and overall low F&V consumption. These observations suggest the need to further efforts to increase F&V consumption and for more rigorous evaluation of the role of F&V in PAD prevention. VISUAL OVERVIEW: An online visual overview is available for this article.
PMCID:5515295
PMID: 28522699
ISSN: 1524-4636
CID: 2563062

Idiopathic Carotidynia

Policha, Aleksandra; Williams, David; Adelman, Mark; Veith, Frank; Cayne, Neal S
Idiopathic carotidynia is a syndrome characterized by pain and tenderness over the carotid artery without an associated structural luminal abnormality. Controversy exists over whether this is a distinct disease entity or merely a symptom attributable to other causes of neck pain, such as carotid dissection or vasculitis. A 50-year-old woman presented with sudden-onset right neck pain. Imaging studies demonstrated transmural inflammation of the proximal internal carotid artery, without evidence of intraluminal pathology. The patient was placed on low-dose aspirin and ibuprofen. Her symptoms resolved within a week. At 3-month follow-up, her carotid artery appeared normal on duplex ultrasonography.
PMID: 28330435
ISSN: 1938-9116
CID: 2494842

Aberrant left vertebral artery transposition and concomitant carotid-subclavian bypass for treatment of acute intramural hematoma with thoracic endovascular aortic repair

Blumberg, Sheila N; Adelman, Mark A; Maldonado, Thomas S
Aberrant left vertebral artery (LVA) origin off the aortic arch is an uncommon anatomic variant. Treatment of the thoracic aortic pathology that necessitates its coverage has not been described. We present a patient with an acute intramural hematoma with a dominant LVA originating from the aortic arch. A LVA-to-carotid artery transposition with shunt placement, carotid-to-subclavian bypass, and thoracic endovascular aortic repair were performed. The patient recovered uneventfully, without any evidence of stroke. This case study shows that aberrant left vertebral anatomy presents a unique and interesting challenge and that vertebral shunt techniques during revascularization can be performed without stroke.
PMID: 27889285
ISSN: 1097-6809
CID: 2329132

Diabetes mellitus is a coronary heart disease risk equivalent for peripheral vascular disease

Newman, Jonathan D; Rockman, Caron B; Kosiborod, Mikhail; Guo, Yu; Zhong, Hua; Weintraub, Howard S; Schwartzbard, Arthur Z; Adelman, Mark A; Berger, Jeffrey S
Diabetes mellitus (diabetes) is associated with significantly increased risk of peripheral vascular disease. Diabetes is classified as a coronary heart disease (CHD) risk equivalent, but it is unknown whether diabetes is a CHD risk equivalent for peripheral vascular disease. The objective was to evaluate the odds of peripheral arterial disease (PAD) or carotid artery stenosis (CAS) among participants with diabetes, CHD, or both, compared with participants without diabetes or CHD, in a nationwide vascular screening database. We hypothesized that diabetes and CHD would confer similar odds of PAD and CAS. METHODS: A cross-sectional analysis of all eligible Life Line Screening Inc participants age 30 to 90 years with ankle brachial indices for PAD (ankle brachial index <0.9 in either leg) and carotid artery duplex ultrasonographic imaging for CAS (internal CAS >/=50%) was performed (N=3,522,890). RESULTS: Diabetes and CHD were present in 372,330 (10.7%) and 182,760 (5.8%) of participants, respectively; PAD and CAS were present in 155,000 (4.4%) and 130,347 (3.7%) of participants. After multivariable adjustment, PAD odds were 1.56 (95% CI 1.54-1.59) and 1.69 (95% CI 1.65-1.73) for participants with diabetes or CHD, respectively. Participants with both diabetes and CHD had 2.75-fold increased odds of PAD (95% CI 2.66-2.85). Findings were similar for CAS; compared with no diabetes or CHD, CAS odds increased for participants with diabetes alone (1.53, 95% CI 1.50-1.56), CHD alone (1.72, 95% CI 1.68-1.76), and both diabetes and CHD (2.57, 95% CI 2.49-2.66). Findings were consistent for women and men. CONCLUSION: In a large database of more than 3.5 million self-referred participants, diabetes was a CHD risk equivalent for PAD and CAS, and participants with comorbid diabetes and CHD had an especially robust association with PAD and CAS. Counseling regarding screening and prevention of peripheral vascular disease may be useful for patients with diabetes.
PMCID:5325078
PMID: 28224925
ISSN: 1097-6744
CID: 2455482

Compression vs No Compression After Endovenous Ablation of the Great Saphenous Vein: A Randomized Controlled trial

Ayo, Diego; Blumberg, Sheila N; Rockman, Caron R; Sadek, Mikel; Cayne, Neal; Adelman, Mark; Kabnick, Lowell; Maldonado, Thomas; Berland, Todd
OBJECTIVE: The goal of this study is to determine if compression therapy after endovenous ablation (EVA) of the great saphenous vein (GSV) improves efficacy and patient reported outcomes of pain, ecchymosis and quality of life. METHODS: This was a prospective randomized controlled trial from 2009 to 2013 comparing the use of thigh-high 30-40mmHg compression therapy for 7 days vs no compression therapy following endovenous ablation of the GSV. Severity of venous disease was measured by CEAP scale and the venous clinical severity score (VCSS). Quality of life assessments were carried out with a CIVIQ-2 questionnaire at days 1, 7, 14, 30 and 90, and the visual analog pain scale daily for the first week. Bruising score was assessed at 1 week post procedure. Post ablation venous duplex was also performed. RESULTS: 70 patients and 85 limbs with EVA were randomized. EVA modalities included radiofrequency ablation (91%) and laser ablation (9%). CEAP class and VCSS scores were equivalent between the two groups. There was no significant difference in patient reported outcomes of post-procedural pain scores at day 1 (mean 3.0 vs. 3.12, p =0.948) and at day 7 (mean 2.11 vs 2.81,p =0.147), CIVIQ-2 scores at 1 week (mean 36.9 vs 35.1, p=0.594), at 90 days (mean 29.1 vs 22.5, p =0.367) and bruising score (mean 1.2 vs 1.4,p=0.561) in the compression vs. no compression groups respectively. Additionally, there was a 100% rate of GSV closure in both groups and no endothermal heat-induced thrombosis (eHIT) as assessed by post-ablation duplex. CONCLUSION: Compression therapy does not significantly affect both patient reported and clinical outcomes after GSV ablation in patients with non-ulcerated venous insufficiency. It may be an unnecessary adjunct following GSV ablation.
PMID: 27554689
ISSN: 1615-5947
CID: 2221512