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Intraoperative Management and Factors Contributing to Intolerance of Reversal of Flow in Transcarotid Artery Revascularization [Meeting Abstract]

Teter, K; Rockman, C; Lamparello, P; Garg, K; Barfield, M; Jacobowitz, G; Maldonado, T S
Objective: In patients deemed high risk for carotid endarterectomy (CEA) who are indicated for treatment of carotid artery stenosis (CAS), transcarotid artery revascularization (TCAR) has been demonstrated to be a safe and effective alternative to transfemoral CAS. Compared with CEA, in which approximately 12% of patients undergoing awake intervention do not tolerate internal carotid artery clamping, only 1% to 2% of patients were observed to have intolerance to flow reversal during TCAR based on data from the Safety and Efficacy Study for Reverse Flow Used During Carotid Artery Stenting Procedure (ROADSTER) 1 and 2 trials. This study reviewed awake interventions from those trials to assess factors associated with intolerance to flow reversal and to review how those cases were managed.
Method(s): This is a retrospective review of prospectively collected data from the ROADSTER multicenter trial along with the subsequent postapproval (ROADSTER 2) trial. The subset of patients from both trials undergoing awake TCAR was analyzed to compare demographics, procedural details, and anatomic factors between patients who did and did not experience intolerance to reversal of flow to assess for predisposing factors. Patients were deemed intolerant to flow reversal at the discretion of the operator, often related to changes in completion of neurologic tasks, hemodynamic stability, or patient-reported symptoms.
Result(s): There were 103 patients from ROADSTER and 194 patients from ROADSTER 2 who underwent TCAR under local/regional anesthesia. Of these, eight patients had intolerance to flow reversal, although all cases were successfully completed. Four cases were completed under low-flow reversal, three cases were successfully weaned from low to high flow during several minutes, and one case required general anesthesia. No significant association was found between intolerance to flow reversal and comorbidities including diabetes mellitus, hypertension, hyperlipidemia, congestive heart failure, prior myocardial infarction or angina, preoperative CAS-related symptoms, prior stroke, prior CAS or CEA, prior neck irradiation, tandem stenosis, high cervical stenosis, or hostile neck (Tables I and II). A trend toward significance was seen with chronic obstructive pulmonary disease (P =.086) and contralateral carotid artery occlusion (P =.139).
Conclusion(s): Despite intolerance to flow reversal, most cases were successfully completed by adjusting reversal of flow rate and did not require conversion to general endotracheal anesthesia. Whereas factors contributing to intolerance of flow reversal during TCAR remain poorly understood, this study identified a trend toward significance with an association of pre-existing chronic obstructive pulmonary disease and contralateral carotid artery occlusion. Given the low number of patients who experienced this issue, a larger sample size is required to better elucidate these trends. [Formula presented] [Formula presented]
Copyright
EMBASE:2006737413
ISSN: 1097-6809
CID: 4521792

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

Endovascular Management of Popliteal Artery Occlusive Disease: Long-term Outcomes of Angioplasty, Stenting and Atherectomy [Meeting Abstract]

Pezold, Michael; Cayne, Neal; Rockman, Caron; Jacobowitz, Glenn; Patel, Virendra I.; Garg, Karan
ISI:000544100700342
ISSN: 0741-5214
CID: 4561992

Impact of Positive Stress Test on Postoperative Cardiac Events in Patients Undergoing Elective Carotid Revascularization [Meeting Abstract]

Patalano, Peter; Rockman, Caron; Jacobowitz, Glenn; Maldonado, Thomas S.; Cayne, Neal; Patel, Virendra I.; Garg, Karan
ISI:000544100700320
ISSN: 0741-5214
CID: 4561982

Small Superficial Femoral Artery Has Worse Outcomes After Endovascular Interventions for Isolated De Novo Stenosis [Meeting Abstract]

Chang, Heepeel; Jacobowitz, Glenn; Rockman, Caron; Cayne, Neal; Patel, Virendra I.; Pezold, Michael; Garg, Karan
ISI:000544100700243
ISSN: 0741-5214
CID: 4561962

Cell-Specific Profiling of Transcriptional Landscape in Human Abdominal Aortic Aneurysm by Single-Cell RNA Sequencing [Meeting Abstract]

Silvestro, M; Hadi, T; Cayne, N S; Maldonado, T S; Gelb, B E; Jacobowitz, G R; Ramkhelawon, B
Objective: Abdominal aortic aneurysm (AAA) is a fatal vascular disease on rupture with still limited mechanistic knowledge of the pathophysiologic process. We sought to determine the heterogeneous cell subtypes and to characterize the spectrum of transcriptome signatures in each cell population within the aneurysmal wall by unbiased single-cell RNA sequencing (scRNA-seq) of human AAA tissue.
Method(s): Aortic specimens were collected from AAA and control healthy organ donor. Samples were processed by enzymatic digestion and mechanical disruption to generate single-cell suspension. Single-cell RNA libraries were prepared after generation of single-cell beads in emulsion. Sequencing was performed on a NovaSeq 6000 platform (Illumina, San Diego, Calif). After alignment, barcode assignment, and sample de-multiplexing, data analysis was performed on t-distributed stochastic neighbor embedding charts of cell transcriptome. Cell clusters were identified by unsupervised proximity based on Euclidian distance and supervised identification of biologic markers within clusters. Pathway analysis algorithms were used to outline biologically relevant networks.
Result(s): Unbiased analysis of scRNA-seq data sets showed 19 different cell clusters with unique transcriptomic signatures in AAA. A total of 8826 significant differentially expressed genes were identified in AAA vs control. Notably, gene transcription-associated extracellular matrix remodeling (COL1A1, COL3A1, COL1A2, LUM), Wnt signaling modulation (SFRP2), and synthetic cellular phenotypes (RPS29, RPS27, RPL13A, RPL28) were among the top increased profiles in AAA tissue. Pathway enrichment analysis of AAA vs control libraries revealed significant modulation of cell proliferation, cell-extracellular matrix interaction, neoangiogenesis, and inflammation. Five novel cell clusters with distinct immune synthetic phenotypes were predominantly abundant in AAA wall compared with the healthy aorta. A robust enrichment in immune cell entities was identified in AAA but not in control tissues, including expansion of CD19+ B lymphocytes and a subset of CD3E+ T lymphocytes significantly expressing IL32 and CCL5. In contrast, smooth muscle cell (ACTA2+MYH11+) number declined in AAA but revealed increased transcription of the protease ADAMTS4 and inflammatory signals (CCL19, CCL21, IL6, CCL2). Intercluster pathway analysis revealed enrichment of eukaryotic initiation factor 2 and mechanistic target of rapamycin signaling in the AAA macrophage population along with an increased number of inflammatory and T-cell activation cascades.
Conclusion(s): To the best of our knowledge, this is the first report of scRNA-seq analysis on human AAA. This cutting-edge technique uncovered novel cell clusters and provided a comprehensive understanding of cellular spatiotemporal changes within the AAA wall. Here we provide novel interconnected mechanistic insights into this complex disease to enrich our understanding of AAA development.
Copyright
EMBASE:2003356445
ISSN: 1097-6809
CID: 4153162

Compression therapy after invasive treatment of superficial veins of the lower extremities: Clinical practice guidelines of the American Venous Forum, Society for Vascular Surgery, American College of Phlebology, Society for Vascular Medicine, and International Union of Phlebology

Lurie, Fedor; Lal, Brajesh K; Antignani, Pier Luigi; Blebea, John; Bush, Ruth; Caprini, Joseph; Davies, Alun; Forrestal, Mark; Jacobowitz, Glenn; Kalodiki, Evi; Killewich, Lois; Lohr, Joann; Ma, Harry; Mosti, Giovanni; Partsch, Hugo; Rooke, Thom; Wakefield, Thomas
Guideline 1.1: Compression after thermal ablation or stripping of the saphenous veins. When possible, we suggest compression (elastic stockings or wraps) should be used after surgical or thermal procedures to eliminate varicose veins. [GRADE - 2; LEVEL OF EVIDENCE - C] Guideline 1.2: Dose of compression after thermal ablation or stripping of the varicose veins. If compression dressings are to be used postprocedurally in patients undergoing ablation or surgical procedures on the saphenous veins, those providing pressures >20 mm Hg together with eccentric pads placed directly over the vein ablated or operated on provide the greatest reduction in postoperative pain.[GRADE - 2; LEVEL OF EVIDENCE - B] Guideline 2.1: Duration of compression therapy after thermal ablation or stripping of the saphenous veins. In the absence of convincing evidence, we recommend best clinical judgment to determine the duration of compression therapy after treatment. [BEST PRACTICE] Guideline 3.1: Compression therapy after sclerotherapy. We suggest compression therapy immediately after treatment of superficial veins with sclerotherapy to improve outcomes of sclerotherapy. [GRADE - 2; LEVEL OF EVIDENCE - C] Guideline 3.2: Duration of compression therapy after sclerotherapy. In the absence of convincing evidence, we recommend best clinical judgment to determine the duration of compression therapy after sclerotherapy. [BEST PRACTICE] Guideline 4.1: Compression after superficial vein treatment in patients with a venous leg ulcer. In a patient with a venous leg ulcer, we recommend compression therapy over no compression therapy to increase venous leg ulcer healing rate and to decrease the risk of ulcer recurrence. [GRADE - 1; LEVEL OF EVIDENCE - B] Guideline 4.2: Compression after superficial vein treatment in patients with a mixed arterial and venous leg ulcer. In a patient with a venous leg ulcer and underlying arterial disease, we suggest limiting the use of compression to patients with ankle-brachial index exceeding 0.5 or if absolute ankle pressure is >60 mm Hg. [GRADE - 2; LEVEL OF EVIDENCE - C].
PMID: 30554745
ISSN: 2213-3348
CID: 3556432