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Compliance with compression therapy in primary chronic venous disease: Results from a tropical country

Ayala, Álvaro; Guerra, Jose D; Ulloa, Jorge H; Kabnick, Lowell
Objectives To describe compliance rates of compression therapy in a cohort of patients with chronic venous disease and also to describe frequent causes of non-compliance. Methods A total of 889 patients with primary chronic venous disease were prescribed compression therapy after being evaluated by vascular surgeons. Subjects had a first visit during which time compression therapy was prescribed in addition to a follow-up visit. Strength of compression, type, prescription duration, and reasons of non-compliance were queried at follow-up. Results Only 31.8% of the patients reported wearing compression therapy as prescribed, 31.4% reported wearing compression most days, 28.3% reported wearing compression intermittently, and 8.5% of the patients reported not wearing compression at all. The main reasons of non-compliance were: uncomfortable (49.4%), too difficult to put on (34.5%), skin problems (itching) (21.5%), and unattractive (19.8%). Conclusions Compliance with compression therapy in chronic venous disease is still a subject of concern as most patients are not using compression therapy as prescribed.
PMID: 30189813
ISSN: 1758-1125
CID: 3274792

Quality Payment Program compliance and vein center acreditation

Ozsvath, Kathleen; Kabnick, Lowell S; Johnson, Brad; Rathbun, Jill; Woo, Karen
PMID: 29661367
ISSN: 2213-3348
CID: 3042692

Reply [Letter]

Kabnick, Lowell; Lawrence, Peter
PMID: 29661374
ISSN: 2213-3348
CID: 3042702

Age is not a barrier to good outcomes after varicose vein procedures

Sutzko, Danielle C; Andraska, Elizabeth A; Obi, Andrea T; Sadek, Mikel; Kabnick, Lowell S; Wakefield, Thomas W; Osborne, Nicholas H
BACKGROUND: The Vascular Quality Initiative (VQI) Varicose Vein Registry (VVR) represents a patient-centered database launched in January 2015. Previous work describing overall trends and outcomes of varicose vein procedures across the United States demonstrates a benefit from these procedures. The existing gaps in evidence to support current and future Medicare coverage of varicose vein procedures necessitate further description of clinical outcomes in patients >/=65 years old compared with the population <65 years old. METHODS: This study analyzed prospectively captured anatomic, procedural, and outcome data for all patients in a national cohort of all VQI VVR-participating centers. The VQI VVR database was queried for all patients undergoing varicose vein procedures between January 2015 and July 2016. Preprocedural and postprocedural Clinical, Etiology, Anatomy, and Pathophysiology (CEAP) classification, Venous Clinical Severity Score (VCSS), and patient-reported outcomes (PROs) were compared between patients <65 years and >/=65 years old. Univariate descriptive statistics of demographic and procedural data were performed. Student t-tests were then performed on change in CEAP classification, VCSS score, and PROs (heaviness, achiness, throbbing, swelling, itching, appearance, and impact on work) for each group. RESULTS: There were 4841 varicose vein procedures performed from January 2015 to May 2016. There were 3441 procedures performed in 2691 patients (3631 limbs) in the group <65 years old and 1400 procedures performed in 1068 patients (1467 limbs) in the group >/=65 years old. Truncal veins alone were the most common veins treated in both groups. The majority of patients were white and female in both groups. Most of the demographic characteristics were clinically similar (although statistically different) in both groups with the exception of a higher body mass index in the group <65 years old and a history of bilateral varicose vein treatment, and anticoagulation was more common among patients >/=65 years old. Patients in both groups experienced statistically significant improvement in VCSS, PROs, and CEAP class. There was no difference in overall complications between age groups. CONCLUSIONS: All patients demonstrated an associated improvement in both clinical outcomes (CEAP class, VCSS) and PROs. There was no significant difference in the improvement in CEAP class and VCSS between patients younger and older than 65 years, although the younger population reported greater improvement in PROs. Given these findings, patients older than 65 years appear to benefit from varicose vein procedures and should not be denied interventions on their varicose veins and venous insufficiency on the basis of their age only.
PMCID:5584572
PMID: 28818215
ISSN: 2213-3348
CID: 2669082

The Impact of Different Treatment Modalities on Recalcitrant Venous Ulcer Healing [Meeting Abstract]

Lawrence, Peter; Hager, Eric; Harlander-Locke, Michael P; Kabnick, Lowell; Saqib, Naveed; Charlton-Ouw, Kristofer M; Kiguchi, Misaki
ISI:000403108000340
ISSN: 0741-5214
CID: 2611512

Proposal for a national coverage determination for the treatment of varicose veins and venous disease due to disparate Centers for Medicare and Medicaid Services local coverage determination policies

Welch, Harold J; Kabnick, Lowell; Vasquez, Michael A; Monahan, Daniel L; Lurie, Fedor; Jacobowicz, Glenn
Varicose veins and chronic venous disease are common problems in the United States. Persons with these conditions often have an adversely affected quality of life. There are a number of proven interventions to treat varicose veins and to improve patients' life quality, but these interventions are often restricted by the Centers for Medicare and Medicaid Services and private third-party payers. The Centers for Medicare and Medicaid Services have private contractors that administer Medicare policies in 10 jurisdictions across the United States. There is no national policy or coverage for the treatment of varicose veins; rather, there are multiple, disparate regional policies written by the contractors that cover the same Medicare beneficiary population. These disparate policies are not evidence based and provide unfair coverage of the same disease to the Medicare population, depending on where they live. Our proposal is for a national coverage determination policy for the treatment of varicose veins.
PMID: 28411715
ISSN: 2213-3348
CID: 2532212

First 10-month results of the Vascular Quality Initiative Varicose Vein Registry

Obi, Andrea T; Sutzko, Danielle C; Almeida, Jose I; Kabnick, Lowell; Cronenwett, Jack L; Osborne, Nicholas H; Lal, Brajesh K; Wakefield, Thomas W
OBJECTIVE: The Vascular Quality Initiative Varicose Vein Registry (VQI VVR) represents a new Patient Safety Organization database launched in January 2015 as a collaborative effort between the American Venous Forum and the Society for Vascular Surgery. This study was undertaken to identify real-world trends among treatment choices and outcomes of varicose vein patients. METHODS: Registry data prospectively captured anatomic, procedural, and outcome data for patients with C2 or more severe disease undergoing intervention for venous varicosities from January to November 2015. Univariate descriptive statistics of demographic and procedural data was performed. Preprocedural and postprocedural comparisons were performed with t-test or chi2 analysis as appropriate. RESULTS: In total, 2661 veins in 1803 limbs of 1406 patients were treated for varicose vein disease. The majority of patients were female (71.5%) and white (78.3%). Previous varicose vein treatment had been undertaken by 31.2%. The most common site of reflux was the great saphenous vein in 74.4%, with 31% of patients having coexisting deep venous reflux. The right and left extremities were affected equally. Endovenous treatment of axial reflux was the preferred treatment in 89.1%, divided largely between radiofrequency ablation (55.2%) and endovenous laser ablation (33.9%). Clusters were often treated concomitantly with truncal reflux (n = 488 [76%]). The majority of cluster treatments were performed in an office-based setting (78.1%). The majority of clusters were located at the calf (89.7%) and treated with stab phlebectomy (84.8%). For all patients undergoing intervention for varicose veins, Venous Clinical Severity Score (VCSS) improved on average 4.68 +/- 3.35 (n = 719; P < .001) postoperatively from a mean preoperative VCSS of 9.39 +/- 3.87 to a mean postoperative VCSS of 4.71 +/- 3.83. Improvements were seen in patient-reported outcomes (PROs) of heaviness, achiness, throbbing, swelling, itching, appearance, and work impact (total score change, 10.75 +/- 6.94; n = 607; P < .001) from a mean preoperative PRO score of 16.48 +/- 6.23 to a mean postoperative PRO score of 5.73 +/- 5.80. CONCLUSIONS: The VQI VVR provides detailed assessment of varicose vein interventions and is useful for monitoring of changes after treatment. Modern-day varicose vein surgery is characterized by predominantly endovenous treatment of axial vein reflux, phlebectomy of clusters, and substantial improvements in both VCSS and PROs.
PMID: 28411696
ISSN: 2213-3348
CID: 2532202

A multicenter, randomized, placebo-controlled study to evaluate the efficacy and safety of Varithena(R) (polidocanol endovenous microfoam 1%) for symptomatic, visible varicose veins with saphenofemoral junction incompetence

Gibson, Kathleen; Kabnick, Lowell
OBJECTIVES: A randomized, placebo-controlled, multicenter study was conducted to evaluate the safety and efficacy of polidocanol endovenous microfoam (1%, Varithena(R) [polidocanol injectable foam], BTG International Ltd.). METHODS: Patients (n = 77) with symptomatic, visible varicose veins were randomized to treatment with either Varithena 1% or placebo. RESULTS: Varithena provided greater mean changes from Baseline in patient-reported assessments of symptoms (e.g., heaviness, achiness, swelling, throbbing, itching [HASTI(R)] score 30.7 points vs 16.7 points, p = 0.0009, primary endpoint; and modified Venous Insufficiency Epidemiological and Economic Study-Quality-of-Life/Symptoms [m-VEINES-QOL/Sym; p < 0.001]), physician-assessed VCSS, and physician- and patient-assessed appearance compared with placebo.The HASTI score correlated highly with the modified-VEINES-QOL/Sym and Chronic Venous Insufficiency Questionnaire-2 scores (r = 0.7 to > 0.9, p
PMCID:5405826
PMID: 27013511
ISSN: 1758-1125
CID: 2052222

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

A preclinical animal study of a novel, simple, and secure percutaneous vessel occluder for the treatment of varicose veins

Miller, Arnold; Lilach, Nir; Miller, Raanan; Kabnick, Lowell
BACKGROUND: Secure, permanent occlusion of the great and small saphenous veins, their tributaries, and perforators is critical for the successful treatment of varicose veins. Current minimally invasive methods replacing surgery are all endoluminal and involve heat (radiofrequency or laser), chemicals (sclerosants and glues), or a combination of mechanical and chemical interventions. This study evaluated in a porcine model the performance of a percutaneous delivery of the Amsel Vessel Occluder (AVO; Amsel Medical Corp, Cambridge, Mass) using ultrasound guidance. The AVO has received United States Food and Drug Administration premarket 510(k) clearance for use in open surgical procedures for tubular structures with diameters of 2 to 7 mm. METHODS: The AVO, a novel mechanical occlusion clip similar to a transfixion suture, is delivered through an 18-gauge hypodermic needle. The AVO is subsequently expanded on either side of the vessel wall, collapsed, and locked together to effect secure vascular occlusion, thus transfixing the targeted vessel. The targeted vessels in five swine (weight >60 kg) under general anesthesia were identified, and the vessel size was measured. Patency of the targeted vessels was confirmed on duplex ultrasound imaging. Each animal provided multiple vessels for percutaneous AVO occlusion. Occlusion was confirmed by duplex ultrasound imaging and by direct examination of the occluded vessel after open surgical exploration. RESULTS: Thirty vessel occlusions were performed percutaneously, including the common and superficial femoral arteries and veins (n = 24), the carotid artery (n = 4), and the external jugular vein (n = 1) and external jugular vein tributary (n = 1). Measured vessel sizes ranged from 1.8 to 12.7 mm. After vessel transfixion, occlusion was achieved in <30 seconds. A second AVO, if necessary, was delivered to completely occlude the targeted vessel where the vessel was >7 mm diameter (n = 2; external jugular vein, 12.7 mm; carotid artery, 7 mm), or where the initial AVO did not occlude the vessel because of nontransfixion (n = 1). Surgical exposure after occlusion confirmed that all targeted vessels were successfully occluded and demonstrated no evidence of injury to any of the adjacent structures. CONCLUSIONS: This study confirms that the AVO can be effectively delivered percutaneously under ultrasound guidance to occlude blood vessels in the porcine model and may be a useful, time-saving, and cost-effective adjunct to current primary methods of treating reflux in the saphenous veins, their tributaries, or perforators for the treatment of symptomatic varicose veins.
PMID: 27987599
ISSN: 2213-3348
CID: 2372392