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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

Natural History, Clinical Significance, and the Role of Vascular Referral in the Management of Penetrating Ulcers of the Abdominal Aorta

Rokosh, Rae S; Shah, Noor; Safran, Brent; Kim, Danny C; Maldonado, Thomas S; Sadek, Mikel; Garg, Karan; Jacobowitz, Glenn; Rockman, Caron
OBJECTIVE:MATERIALS AND METHODS: Patients at our tertiary referral center were identified for inclusion based on a search for the term "penetrating ulcer" in abdominal computed tomography and magnetic resonance imaging reports between January 2014 and December 2017. Patients' electronic medical records were retrospectively reviewed to determine baseline medical characteristics, imaging indication, as well as subsequent clinical course, interventions and outcomes. Aortic diameters and ulcer depths were measured by a single observer on initial and follow-up imaging to assess for association with concomitant aortic pathology, evolving aortic disease, and ulcer progression, defined as increase in depth of ≥ 1mm. Statistical analysis was performed using STATA 16 (College Station, TX: StataCorp LLC), and a threshold p-value of < 0.05 set for significance. RESULTS:Ninety-two patients with PUAA were identified; 57 (62%) were male. The mean age at diagnosis was 79.3 years, and comorbidities included hypertension (74%), hyperlipidemia (65%) and malignancy (34%). The most common indication for imaging was chest, back, or abdominal pain (19%). On initial imaging, mean ulcer depth was 1cm (range from 0.2cm to 3.4cm). Concomitant abdominal aortic dilation ≥ 3cm was found in 34 (37%) patients. Thirty-six (39%) patients had a vascular surgery consultation immediately following radiographic diagnosis. Follow-up axial imaging was performed on 27 (29%) untreated patients. The overall sample's mean ulcer depth remained essentially unchanged from initial measurement (p = .99); however, 14 (52%) patients with follow-up imaging were found to have increased overall aortic diameter. Of the total 92 patients, nine (10%) underwent an endovascular abdominal aortic intervention during the review period: two for symptomatic PUAA and the remainder for progression of concomitant aneurysmal disease. All cause mortality was 5% during mean follow-up period of 21.9 months (range 0 to 72.5 months). Of the patients lost to follow-up, 61% did not receive vascular referral after initial diagnosis. CONCLUSIONS:PUAA are typically incidental findings identified in elderly, comorbid patients undergoing imaging for an unrelated indication. Though isolated findings of an asymptomatic PUAA rarely require surgical intervention, these patients we argue would benefit from vascular surgery referral for long-term follow-up and interval imaging to assess for disease progression as well as concomitant aortic degeneration, which may necessitate repair. In addition, we observed that the majority of those patients lost to follow-up did not receive vascular consultation, suggesting that lack of involvement of vascular specialists at the time of diagnosis is a missed opportunity to secure appropriate follow-up and management.
PMID: 32234398
ISSN: 1615-5947
CID: 4370332

Endovenous laser ablation: A comprehensive review

Teter, Katherine A; Kabnick, Lowell S; Sadek, Mikel
OBJECTIVE:To provide an evidence-based overview of endovenous laser ablation and describe its role as an effective and durable technique for the management of superficial venous insufficiency. METHODS:The published literature on the treatment of varicose veins using endovenous laser ablation was reviewed. The literature search focused on the history of endovenous laser ablation, its safety and durability, known complications, and differences in outcomes based on the iterations of fiber type and laser wavelength. RESULTS:Treatment safety and efficacy of endovenous laser ablation appear to be based on the amount of energy administered over a defined distance, or the linear endovenous energy density. The ideal linear endovenous energy density varies with the laser wavelength and fiber-type. Post-operative pain and bruising may be reduced by the use of higher wavelength fibers or the use of radial or jacket-tip fibers as compared to bare-tip fibers. The incidence of endothermal heat-induced thrombosis remains low and has declined with increasing experience. Reports have demonstrated a greater than 90% technical success rate with saphenous endovenous laser ablation, long-term durability of ablation, and commensurate improvement in quality of life. CONCLUSIONS:Endovenous laser ablation is a safe and durable treatment option for the management of incompetent superficial and perforator veins of the lower extremities. As an endothermal technology, it remains a key component of the standard of care for the treatment of chronic venous insufficiency.
PMID: 32631172
ISSN: 1758-1125
CID: 4518922

Radiofrequency and laser vein ablation for patients receiving warfarin anticoagulation is safe, effective, and durable

Westin, Gregory G; Cayne, Neal S; Lee, Victoria; Ekstroem, Jonathan; Yau, Patricia O; Sadek, Mikel; Rockman, Caron B; Kabnick, Lowell S; Berland, Todd L; Maldonado, Thomas S; Jacobowitz, Glenn R
OBJECTIVE:The objective of this study was to evaluate the efficacy, durability, and safety of radiofrequency ablation (RFA) and endovenous laser ablation (EVLA) of the great saphenous vein (GSV) and small saphenous vein (SSV) to treat symptomatic venous reflux in patients receiving therapeutic anticoagulation. METHODS:tests, Fisher exact test, Kaplan-Meier curves, and Cox proportional hazard modeling. RESULTS:There were 100 procedures performed in 65 patients receiving anticoagulation and 127 procedures in 89 control patients. Mean follow-up time was 467 days. The most common indications for anticoagulation were atrial fibrillation (52%), remote DVT (29%), and mechanical heart valves (8%). Patients receiving anticoagulation were on average older (67 years vs 52 years), were more likely to be male (51% vs 27%), and had higher rates of coronary disease (9% vs 0%) and hypertension (55% vs 20%), although they were more likely to have never smoked (86% vs 69%). There were 127 RFA procedures (56%) and 100 EVLA procedures (44%); 189 procedures treated the GSV or its tributaries (83%), and 38 treated the SSV (17%). At 1 year, the target vessel remained ablated after 96% of procedures performed with anticoagulation and in 99% of controls; at 18 months, rates were 92% vs 95% (P = .96). Rates of persistent ablation did not differ significantly by vessel treated (P = .28), EVLA vs RFA (P = .36), or use of antiplatelet therapy (P = .92). One patient had bleeding from a phlebectomy site 2 days postprocedurally when supratherapeutic on warfarin; this was controlled with pressure. DVT in the ipsilateral leg occurred within 90 days after 1 of 100 (1%) procedures in patients receiving anticoagulation and 2 of 127 (1.6%) procedures in control patients; endothermal heat-induced thrombosis rates were similarly 1 of 100 (1%) procedures in patients receiving anticoagulation and 1 of 127 (0.8%) in control patients. CONCLUSIONS:This is the largest series to date reporting >30-day follow-up for patients undergoing venous ablation procedures while receiving anticoagulation and the longest follow-up reported of any series. Durability, safety, and efficacy of vein ablation in patients receiving anticoagulation are comparable to those in control patients. Anticoagulation should not be considered a contraindication to endothermal ablation of the GSV or SSV for symptomatic venous reflux.
PMID: 31987758
ISSN: 2213-3348
CID: 4293992

Increased ischemic complications in fenestrated and branched endovascular abdominal aortic repair compared with standard endovascular aortic repair

Westin, Gregory G; Rockman, Caron B; Sadek, Mikel; Ramkhelawon, Bhama; Cambria, Matthew R; Silvestro, Michele; Garg, Karan; Cayne, Neal S; Veith, Frank J; Maldonado, Thomas S
OBJECTIVE:Ischemic complications (including in the lower extremity, visceral, spinal, and pelvic territories) following standard endovascular aortic repair (EVAR) are well recognized but fortunately uncommon. The incidence of such complications following fenestrated and branched aortic repair (F/BEVAR) has not been well defined in the literature. The objective of this study was to compare the incidence of ischemic complications between EVAR and F/BEVAR and to elucidate potential risk factors for these complications. METHODS:We identified all patients who underwent EVAR from 2003 to 2017 or F/BEVAR from 2012 to 2017 in the national Vascular Quality Initiative database. We assessed differences in perioperative ischemic outcomes with methods including logistic regression and inverse probability of treatment propensity score weighting, using a composite endpoint of lower extremity ischemia, intestinal ischemia, stroke, or new dialysis as the primary endpoint. RESULTS:The data comprised 35,379 EVAR patients and 3374 F/BEVAR patients. F/BEVAR patients were more likely to be female, have had previous aneurysm repairs, and be deemed unfit for open aneurysm repair; they were less likely to have ruptured aneurysms; and they had higher estimated blood losses, contrast volumes, and fluoroscopy and procedure times. The incidence of any ischemic event (7.7% vs 2.2%) as well as the incidences of the component endpoints of lower extremity ischemia (2.3% vs 1.0%), intestinal ischemia (2.7% vs 0.7%), stroke (1.5% vs 0.3%), and new hemodialysis (3.1% vs 0.4%) were all significantly increased (all P < .001) in F/BEVAR compared with standard EVAR. After propensity adjustment, F/BEVAR conferred increased odds of any ischemic complication (1.8), intestinal ischemia (2.0), lower extremity ischemia (1.3), new hemodialysis (10.2), and stroke (2.3). CONCLUSIONS:Rates of lower extremity ischemia, intestinal ischemia, new dialysis, and stroke each range from 0% to 1% for standard EVAR and 1% to 3% for F/BEVAR. The incidence of perioperative ischemic complications following F/BEVAR is significantly increased compared to EVAR. The real-world data in this study should help guide decision-making for surgeons and patients as well as serve as one metric for progress in device and technique development. Improvements in ischemic complications may come from continued technology development such as smaller sheaths, improved imaging to decrease procedure time and contrast volume, embolic protection, and increased operator skill with wire and catheter manipulation.
PMID: 32081484
ISSN: 1097-6809
CID: 4312642

High Prevalence and Mortality Associated with Upper Extremity Deep Venous Thrombosis in Hospitalized Patients at a Tertiary Care Center

Rokosh, Rae S; Ranganath, Neel; Yau, Patricia; Rockman, Caron; Sadek, Mikel; Berland, Todd; Jacobowitz, Glenn; Berger, Jeff; Maldonado, Thomas S
OBJECTIVE:MATERIAL AND METHODS: This is a single tertiary care center retrospective cohort study of all consecutive inpatients diagnosed with acute VTE from June 2015 to December 2015. During this period, 4495 patients underwent venous duplex examination (622 UE and 3873 LE), identifying 83 inpatient DVTs. Chronic DVT as well as those diagnosed in the outpatient population were excluded. DVTs were classified as either provoked or unprovoked. Provoked DVT were defined as the presence of any of the following factors within 30 days prior to diagnosis: major surgery, immobilization (greater than 3 days of bedrest), trauma, infection requiring antibiotics, central venous access, pregnancy, and/or hormonal medication use. Inpatient pulmonary embolisms (PE) detected on chest computed tomography (CT) were also evaluated during this time frame. Patient data were collected including age, gender, race, lifestyle factors, comorbidities, VTE risk factors, symptomatology at presentation, management including anticoagulation choice and filter placement if applicable, as well as discharge disposition. Statistical analysis was performed using GraphPad Prism 8.0 (GraphPad Software, San Diego, California, USA), and a threshold p-value of < 0.05 set for significance. RESULTS:During the study period, 83 DVTs (48 LEDVT, 35 UEDVT) and 24 PE were identified in 96 inpatients. Of these DVTs, 77.1% of these were defined as provoked. Eleven patients had simultaneous DVT and PE, and thirteen patients had PE with presumed occult pelvic or LEDVT. UEDVT patients had a higher proportion of comorbidities than LEDVT patients: coronary artery disease (25.7% vs. 13.1%, p=0.16), congestive heart failure (20% vs. 6.6%, p=0.09), as well as a trend toward higher incidence of malignancy (60% vs. 42.6%, p=0.13). Of provoked VTE, UEDVT correlated more significantly with central venous catheters (88.4% vs. 12.5%, p=<0.0001), but was less commonly associated with prolonged bed rest (19.2% vs. 39.5%, p=0.11). PE was diagnosed in 24/96 (25%) of the study population. Patients with LEDVT were found to have a significantly higher incidence of PE compared to those with UEDVT (34.4% vs. 8.6%, p=0.006). Same-admission mortality for patients with VTE was 13/96 (13.5%). Of these, patients with UEDVT had significantly higher all-cause mortality than patients with LEDVT (28.5% vs. 4.9%, p=0.004). When catheter-related UEDVT were excluded, there remained a significant difference in mortality between non-catheter related UEDVT and LEDVT (33.3% vs. 4.9% p=0.0119). CONCLUSIONS:This study demonstrates a high prevalence of UEDVT in hospitalized patients who experience VTE. Despite a lower incidence of synchronous PE, patients with UEDVT had a higher prevalence of significant medical comorbidities and higher all-cause mortality on the index hospital admission.
PMID: 31669473
ISSN: 1615-5947
CID: 4162582

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.
Copyright
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

Aspiration thrombectomy for the management of acute deep venous thrombosis in the setting of venous thoracic outlet syndrome

Teter, Katherine; Arko, Frank; Muck, Patrick; Lamparello, Patrick J; Khaja, Minhaj S; Huasen, Bella; Sadek, Mikel; Maldonado, Thomas S
PMID: 31888420
ISSN: 1708-539x
CID: 4251272