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Prior authorization as a utilization management tool for elective superficial venous procedures results in high administrative cost and low efficacy in reducing utilization

Lee, Victoria; Berland, Todd; Jacobowitz, Glenn; Rockman, Caron; Sadek, Mikel; Barfield, Michael; Cayne, Neal; Maldonado, Thomas S
OBJECTIVE:Prior authorization (PA) is a process used by payers for safety and cost savings purposes, but it has received criticism for being time-consuming and costly because of administrative burden. Our study evaluated efficacy of PA applied to in-office lower extremity superficial venous procedures. METHODS:All in-office lower extremity venous procedures scheduled to be performed at our institution in 2017 were included in the study. Variables of interest were type of procedure, initial PA status (approved or denied), rationale for the decision, and final status after appeal. Cost analysis was performed using Centers for Medicare and Medicaid Services allowable rates to approximate billing and reimbursement data (proprietary) as well as calculated using industry averages. RESULTS:For 2017, of 1959 procedures scheduled, 57.9% (n = 1134) required PA. Of these, only 6.1% (n = 69) received initial PA denial, and nearly 40% of the denials (n = 27) were overturned after appeal. Of the 42 denials that were upheld, 15 resulted in cancellations; the remainder were performed by patient self-pay (n = 11) or by the provider pro bono (n = 16). Overturned denials were a result of either submission of incomplete clinical data on initial PA request or insufficient documentation of clinical necessity. When Centers for Medicare and Medicaid Services allowable rates were applied for cost analysis, the denials resulted in <$60,000 payer savings. Administrative expenses totaled >$110,000 when industry standards were applied, which far exceeds any calculated payer savings using the same methods. The 15 denials resulting in procedure cancellations (1.3% of all PAs) could be considered a net savings to the health care system but only approximated a mere $30,000. CONCLUSIONS:Our study demonstrates that PA is not a cost-effective measure for utilization management of outpatient superficial venous procedures when surgeon practices are already well aligned with insurance guidelines. For these physicians and physician groups, the administrative cost associated with the PA process exceeds the savings seen by the insurance companies.
PMID: 31859243
ISSN: 2213-3348
CID: 4243132

Advanced Pneumatic Compression: Continued Improvement in Quality of Life Beyond Initial Early Benefits of Decreased Limb Girth [Meeting Abstract]

Maldonado, T; Padberg, F; Rotella, V; Jacobowitz, G; Miller, H; Berland, T; Sadek, M
Objective: The purpose of this study was to evaluate the effect of an advanced pneumatic compression device (APCD) on improving symptoms and quality of life in patients with lower extremity lymphedema.
Method(s): A total of 178 patients with lower extremity lymphedema were prospectively enrolled in this multicenter study (four Veterans Administration Hospitals) from 2016 to 2019. This study represents analysis of the first 74 patients who have completed 52 weeks of APCD treatment. Demographics and patient characteristics (limb girth, body mass index, and stage of lymphedema) were collected at baseline. Primary end points included both generic quality of life assessment (36-Item Short Form Health Survey) and a disease-specific measure (Lymphedema Quality of Life questionnaire) at 12, 24, and 52 weeks of follow-up. Secondary end points compared changes in limb circumference and skin assessment (lymphedema stage) at each follow-up interval visit. Complications including cellulitis episodes, number of clinic visits, and hospital admissions associated with cellulitis were recorded for the 52 weeks before enrollment and compared with similar events within the 52 weeks of treatment with APCD.
Result(s): Patient demographics were as follows: mean age, 67.0 +/- 11.4 years; male sex (n = 70); body mass index, 32.8 +/- 5.9 kg/m2. Most patients had secondary lymphedema (n = 71 [95.9%]), of which the most common cause was chronic venous insufficiency (n = 53 [71.6%]). The majority of patients presented with stage 1 or stage 2 lymphedema (n = 70 [94.6%]); There was a significant decrease in limb girth noted at 12 weeks compared with baseline (28.1 vs 27.3 cm; P =.002), which then plateaued for the remainder of the study period. The 36-Item Short Form Health Survey showed a trend toward quality of life improvement in all areas at 52 weeks (physical component, 39.9 vs 41.7 [P =.1]; mental component, 49.3 vs 51.3 [P =.2]). Lymphedema Quality of Life questionnaire leg scores showed significant continued improvement at each time point (P <.0001). Of the 74 patients, 18 (24.3%) had a history of cellulitis in the 52 weeks before enrollment compared with 7 (9.5%) after 1 year of APCD treatment (P =.01). Among this cellulitis cohort, there was a significant decrease in number of episodes per patient (0.3 vs 0.1; P =.01), total clinic visits (19 vs 6; P =.0003), number of clinic visits per patient (2.2 vs 0.7; P =.06), and number of hospital admissions per patient (0.05 vs 0.1; P =.047).
Conclusion(s): APCD for treatment of lymphedema appears to result in a continued linear improvement in quality of life at least up to 1 year beyond the initial clinical benefit of decreased limb girth. A significant decrease in the number of episodes of cellulitis as well as fewer associated clinic and hospital visits may explain the noted improvement in quality of life for patients and can represent significant cost savings to the health care system.
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EMBASE:2004645555
ISSN: 2213-3348
CID: 4302012

A Single-Center Experience of Anterior Accessory Great Saphenous Vein Endothermal Ablation Demonstrates Safety and Efficacy [Meeting Abstract]

Charitable, John F.; Rockman, Caron; Jacobowitz, Glenn; Garg, Karan; Maldonado, Thomas S.; Berland, Todd; Cayne, Neal; Sadek, Mikel
ISI:000544100700371
ISSN: 0741-5214
CID: 4562002

Endovascular Creation of Arteriovenous Fistulae for Hemodialysis Access with a 4 Fr Device: Clinical Experience from the EASE Study

Berland, Todd L; Clement, Jason; Griffin, Joseph; Westin, Gregory G; Ebner, Adrian
PURPOSE/OBJECTIVE:To describe our clinical experience in using a system with a 4 Fr catheter profile for endovascular creation of arteriovenous fistulae (AVF) in hemodialysis patients. METHODS:This was a multi-operator, single center, single-arm, prospective study intended to evaluate safety and efficacy of a 4 Fr endovascular AVF (endoAVF) system for the creation of vascular access in hemodialysis patients. The study was performed after institutional review board approval at Italian Hospital (Asuncion, Paraguay). Patients were followed at regular intervals through 6 months to determine procedural, maturation, and cannulation success as well as intervention rate and patency. RESULTS:From May to November 2016, 32 patients underwent the endoAVF procedure with no device-related adverse events. An endoAVF was successfully created in the proximal forearm for all 32 patients (20 between the radial artery and radial vein; 12 between the ulnar artery and ulnar vein). Wrist access was used for 72% (23/32) of the procedures for the arterial catheter and 59% (19/32) of the procedures for the venous catheter. The device successfully created an endoAVF in every patient for a technical success rate of 100% (32/32). The device- or procedure-related serious adverse event rate was 3% (1/32); one patient experienced a venous guidewire perforation successfully managed with a stent graft. Primary and cumulative patency rates through 6 months were 83% and 87%, respectively, with an intervention rate of 0.21 per patient-year. Physiological suitability, as defined by target flow rates ≥500 ml/min and cannulation vessel diameters ≥4 mm, were achieved in 91% (29/32) of patients by 90 days. Successful 2-needle cannulation was achieved in 78% (21/27) by 90 days, with mean time to cannulation of 43 ± 14 days. Functional cannulation, as defined by successful 2-needle cannulation for two-thirds of the dialysis sessions within 1 month, was achieved in 95% (20/21) of the patients that were successfully cannulated for an overall rate of 74% (20/27). All patients that achieved functional cannulation had their central venous catheters (CVCs) removed before the 90-day follow up for a CVC removal rate of 74% (20/27). CONCLUSIONS:The 4 Fr endoAVF system allowed for multiple access and fistula creation site options to tailor the procedure to individual patient anatomy. Further, the outcomes are comparable to previous generation endoAVF technology, with a potentially improved safety profile due to the use of arteries at the wrist for access.
PMID: 31075457
ISSN: 1615-5947
CID: 3919272

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

Safety and Effectiveness of Antegrade Superficial Femoral Artery Access in an Office-Based Ambulatory Setting [Meeting Abstract]

Blumberg, Sheila N; Sadek, Mikel; Maldonado, Thomas; Jacobowitz, Glenn; Gelbfish, Gary; Cayne, Neal; Rockman, Caron; Berland, Todd
ISI:000403108000319
ISSN: 0741-5214
CID: 2611492

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

In patients with a femoral vein deep venous thrombosis, central venous imaging may identify potentially treatable iliocaval thrombosis [Meeting Abstract]

Barfield, M; Kabnick, L; Maldonado, T; Jacobowitz, G; Rockman, C; Cayne, N; Berland, T; Adelman, M; Sadek, M
Background: Patients who present acutely with a femoral vein deep venous thrombosis (DVT) diagnosed by ultrasound are often treated with anticoagulation and instructed to follow up electively. This study sought to assess whether obtaining central imaging in this cohort of patients results in an increased diagnosis of iliocaval DVT and consequently an increased consideration for interventional treatments to effect thrombus removal. Methods: This study was a retrospective review of a prospectively maintained RedCap database from November 2014 through August 2016, which is coordinated by the Venous Thromboembolic Center at our institution. Consecutive patients who were diagnosed by ultrasound with a femoral vein DVT were evaluated. The patients who underwent confirmatory central venous imaging (computed tomography venography, magnetic resonance venography; group A) were compared with the patients who did not undergo central venous imaging (group B). Demographic variables were collected. The outcomes evaluated were (1) the presence of iliocaval DVT, (2) candidacy for lytic-based therapies, (3) performance of lytic-based therapy, and (4) performance of any invasive treatment (lytic therapy, mechanical thrombectomy, inferior vena cava filter placement, or venous stenting). Additional outcomes included technical success of invasive treatment and complications associated with invasive treatment. Results:A total of 63 patients were identified who presented with a diagnosis of femoral vein DVT. Group A comprised 20 of 63 (31%) patients. Group B comprised the remainder, 43 of 63 (69%). The baseline demographics did not differ significantly, except for gender (Table). The number of patients who were diagnosed with an iliocaval DVT differed significantly (group A, nine [45%]; group B, nine [20%]; P <.0001). The number of patients who underwent lytic therapy differed significantly (group A, eight [40%] - seven at the index admission and one at 1 month; group B, 0 [0%]; P <.0001). The number of patients without relative contraindications to lytic therapy did not differ significantly (group A, 13 [65%]; group B, 34 [79%]; P =.35). The number of patients who underwent any invasive treatment differed significantly between the two cohorts (group A, 12/20 [60%]; group B, 4/43 [9%]; P =.0001). The majority of interventions were technically successful in both groups (group A, 11/12 [91.7%]; group B, 4/4 [100%]; P = 1.00). Conclusions: This study suggests that a significant percentage of patients diagnosed by ultrasound with femoral vein DVTs have a concomitant iliocaval DVT. The data suggest that in patients with a femoral vein DVT, central venous imaging may be indicated to identify potentially treatable iliocaval thrombosis. Long-term data will be required to see if this results in a decrease in post-thrombotic syndrome on a population basis. (table present)
EMBASE:613886388
ISSN: 2213-3348
CID: 2395712

Endovascular Treatment of Nutcracker Syndrome

Policha, Aleksandra; Lamparello, Patrick; Sadek, Mikel; Berland, Todd; Maldonado, Thomas
OBJECTIVES: Nutcracker syndrome, or mesoaortic compression of the left renal vein (LRV), with associated symptoms related to venous hypertension in the left kidney, is a rare entity that may result in severe symptoms requiring operative intervention. We report on three patients who presented with nutcracker syndrome, including one patient with a circumaortic LRV resulting in posterior nutcracker syndrome, who underwent successful endovascular treatment with renal vein stenting. A review of existing literature on endovascular management of nutcracker syndrome follows. METHODS: Three women (age range 28 to 43 years) presented with symptoms and imaging studies consistent with nutcracker syndrome. Symptoms included pelvic and flank pain in all three patients, and episodes of hematuria in two. Imaging studies demonstrated compression of the LRV between the superior mesenteric artery and aorta in two of the patients. The third patient was noted to have a circumaortic LRV. RESULTS: All three patients underwent venography and LRV stenting. Stents included a 12 x 40 mm self-expanding nitinol stent, 14 x 60 mm Wallstent, and 16 x 40 mm Wallstent. All patients were placed on clopidogrel post-operatively. The duration of follow-up ranged from six to twenty-seven months. At follow up, all three patients reported significant symptomatic improvement, and duplex ultrasonography demonstrated stent patency in all. CONCLUSIONS: Nutcracker syndrome is a rare condition that can be successfully treated with renal vein stenting via an endovascular approach. Results are encouraging at follow-up periods beyond two years.
PMID: 27321979
ISSN: 1615-5947
CID: 2159032

Mesenteric vein thrombosis can be safely treated with anticoagulation but is associated with significant sequelae of portal hypertension

Maldonado, Thomas S; Blumberg, Sheila N; Sheth, Sharvil U; Perreault, Gabriel; Sadek, Mikel; Berland, Todd; Adelman, Mark A; Rockman, Caron B
BACKGROUND: Mesenteric venous thrombosis (MVT) is a relatively uncommon but potentially lethal condition associated with bowel ischemia and infarction. The natural history and long-term outcomes are poorly understood and under-reported. METHODS: A single-institution retrospective review of noncirrhotic patients diagnosed with MVT from 1999 to 2015 was performed using International Classification of Diseases, Ninth Revision and radiology codes. Patients were excluded if no radiographic imaging was available for review. Eighty patients were identified for analysis. Demographic, clinical, and radiographic data on presentation and at long-term follow-up were collected. Long-term sequelae of portal venous hypertension were defined as esophageal varices, portal vein cavernous transformation, splenomegaly, or hepatic atrophy, as seen on follow-up imaging. RESULTS: There were 80 patients (57.5% male; mean age, 57.9 +/- 15.6 years) identified; 83.3% were symptomatic, and 80% presented with abdominal pain. Median follow-up was 480 days (range, 1-6183 days). Follow-up radiographic and clinical data were available for 50 patients (62.5%). The underlying causes of MVT included cancer (41.5%), an inflammatory process (25.9%), the postoperative state (20.7%), and idiopathic cases (18.8%). Pancreatic cancer was the most common associated malignant neoplasm (53%), followed by colon cancer (15%). Twenty patients (26%) had prior or concurrent lower extremity deep venous thromboses. Most patients (68.4%) were treated with anticoagulation; the rest were treated expectantly. Ten (12.5%) had bleeding complications related to anticoagulation, including one death from intracranial hemorrhage. Four patients underwent intervention (three pharmacomechanical thrombolysis and one thrombectomy). One patient died of intestinal ischemia. Two patients had recurrent MVT, both on discontinuing anticoagulation. Long-term imaging sequelae of portal hypertension were noted in 25 of 50 patients (50%) who had follow-up imaging available. Patients with long-term sequelae had lower recanalization rates (36.8% vs 65%; P = .079) and significantly higher rates of complete as opposed to partial thrombosis at the initial event (73% vs 43.3%; P < .005). Long-term sequelae were unrelated to the initial cause or treatment with anticoagulation (P = NS). CONCLUSIONS: Most cases of MVT are associated with malignant disease or an inflammatory process, such as pancreatitis. A diagnosis of malignant disease in the setting of MVT has poor prognosis, with a 5-year survival of only 25%. MVT can be effectively treated with anticoagulation in the majority of cases. Operative or endovascular intervention is rarely needed but important to consider in patients with signs of severe ischemia or impending bowel infarction. There is a significant incidence of radiographically noted long-term sequelae from MVT related to portal venous hypertension, especially in cases of initial complete thrombosis of the mesenteric vein.
PMID: 27638992
ISSN: 2213-3348
CID: 2247192