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Thrombosis at Hospital Presentation in Patients with and without COVID-19

Brosnahan, Shari B; Smilowitz, Nathaniel R; Amoroso, Nancy E; Barfield, Michael; Berger, Jeffery S; Goldenberg, Ronald; Ishida, Koto; Talmor, Nina; Torres, Jose; Yaghi, Shadi; Yuriditsky, Eugene; Maldonado, Thomas
OBJECTIVE:To better characterize COVID-19 patients most at risk for severe, outpatient thrombosis by defining patients hospitalized with COVID-19 with an arterial or venous thrombosis diagnosed at admission METHODS AND RESULTS: We conducted a single center retrospective analysis of COVID-19 patients. There was a shift in the proportions of thrombosis subtypes from 2019 to 2020, with declines in STEMI (from 22.0% to 10.1% of thrombotic events) and stroke (from 48.6% to 37.2%), and an increase in the proportion of patients with VTE (29.4% to 52.7%). COVID-associated thrombosis were younger (58 years vs. 64 years, p=0.043), trended to be less frequently female (31.3% vs. 43.9%, p =0.16), but there was no difference body mass index or major comorbidities between those with and without COVID-19. COVID-19-associted thrombosis was correlated with a higher mortality (15.2% vs. 4.3%, p=0.016). The biometric profile of patients admitted with COVID-associated thrombosis compared to regular thrombosis had significant changes in the complete blood count, liver function tests, d-dimer, c-related protein, ferritin, and coagulation panels. CONCLUSIONS:Outpatients with COVID-19 who developed thrombosis requiring hospitalization have an increased mortality over non-COVID-19 outpatients who develop thrombosis requiring hospitalization. Given the significantly higher inflammatory markers, it is possible this is related to different mechanisms of thrombotic disease in these patients. The inflammation may be a target to reduce the risk of or aid in the treatment of thrombosis. We call for more studies elucidating the role immunothrombosis maybe playing in COVID.
PMCID:7655032
PMID: 33186750
ISSN: 2213-3348
CID: 4672082

Endovascular Treatment of Popliteal Artery Aneurysms Has Comparable Long-Term Outcomes to Open Repair with Shorter Length of Stay

Shah, Noor G; Rokosh, Rae S; Garg, Karan; Safran, Brent; Rockman, Caron B; Maldonado, Thomas S; Sadek, Mikel; Lamparello, Patrick; Jacobowitz, Glenn R; Barfield, Michael E; Veith, Frank; Cayne, Neal S
OBJECTIVE:Over the past two decades, the treatment of popliteal artery aneurysms (PAAs) has undergone a transformation. While open surgical repair (OR) remains the gold standard for treatment, endovascular repair (ER) has become an attractive alternative in select patient populations. The objective of this study was to compare the outcomes of open versus endovascular repair of PAAs at a single institution. METHODS:We performed a retrospective chart review of all patients between 1998 and 2017 who underwent repair for PAA. Patient baseline, anatomic, and operative characteristics as well as outcomes were compared between the open and endovascular cohorts. The intervention and treatment were at the discretion of the surgeon. RESULTS:Between 1998 and 2017, a total of 64 patients underwent repair of 73 PAAs at our tertiary care center. Twenty-nine patients with 33 PAAs underwent OR, and 35 patients with 40 PAAs underwent ER. When comparing the 2 cohorts, there were no statistically significant differences in demographic characteristics such as age, gender, or number of run-off vessels. There were significantly more patients in the ER group (21/53%) than the OR group (7/21%) with hyperlipidemia (p=.008) and a prior carotid intervention (6% vs. 0%, p=.029). Overall, the presence of symptoms was similar amongst the two groups; however, patients in the OR group had a significantly higher number of patients presenting with acute ischemia (p=.01). Length of stay (LOS) was significantly shorter in the ER cohort (mean 1.8 days [1-11]) compared to the OR group (5.4 days [2-13]) (p<.0001). There was no significant difference in primary or secondary patency rates between the two groups. In the ER group, good runoff (≥2 vessels) was a positive predictor for primary patency at 1 year (3.36 [1.0-11.25]), however, it was not in the OR group. Post-operative single and/or dual anti-platelet therapy did not affect primary patency in either cohort. CONCLUSIONS:The results of our study demonstrate that ER of PAAs is a safe and durable option with comparable patency rates to OR and a decreased LOS, with good run-off being a positive predictor for primary patency in the ER cohort.
PMID: 33957229
ISSN: 1097-6809
CID: 4866682

Deep Venous Thrombosis in Hospitalized Patients with Coronavirus Disease 2019

Chang, Heepeel; Rockman, Caron B; Jacobowitz, Glenn R; Speranza, Giancarlo; Johnson, William S; Horowitz, James M; Garg, Karan; Maldonado, Thomas S; Sadek, Mikel; Barfield, Michael E
OBJECTIVES/OBJECTIVE:The pandemic of Coronavirus disease 2019 (COVID-19) has caused devastating morbidity and mortality worldwide. In particular, thromboembolic complications have emerged as a key threat in COVID-19. We assessed our experience with deep venous thrombosis (DVT) in patients with COVID-19. METHODS:We performed a retrospective analysis of all patients with COVID-19 undergoing upper or lower extremity venous duplex ultrasonography at an academic health system in New York City between March 3 2020 and April 12 2020 with follow-up through May 12 2020. A cohort of hospitalized patients without COVID-19 (non-COVID-19) undergoing venous duplex ultrasonography from December 1 2019 to December 31 2019 was used for comparison. The primary outcome was DVT. Secondary outcomes included pulmonary embolism (PE), in-hospital mortality, admission to intensive care unit, and antithrombotic therapy. Multivariable logistic regression was performed to identify risk factors for DVT and mortality. RESULTS:Of 443 patients (188 COVID-19 and 255 non-COVID-19) undergoing venous duplex ultrasonography, patients with COVID-19 had higher incidence of DVT (31% vs. 19%; P=0.005), compared to the non-COVID-19 cohort. The incidence of PE was not statistically different between the COVID-19 and non-COVID-19 cohorts (8% vs. 4%; P=.105). The DVTs in the COVID-19 group were more distal (63% vs. 29%; P<.001) and bilateral (15% vs. 4%; P<.001). The result of duplex ultrasonography had a significant impact on the antithrombotic plan; 42 (72%) patients with COVID-19 in the DVT group had their therapies escalated while 49 (38%) and 3 (2%) patients had their therapies escalated and de-escalated in the non-DVT group, respectively (P<.001). Within the COVID-19 cohort, the D-dimer was significantly higher in the DVT group at the time of admission (2,746 ng/mL vs 1,481 ng/mL; P=.004) and at the time of the duplex exam (6,068 ng/mL vs. 3,049 ng/mL; P<0.01). At multivariable analysis, male sex (odd ratio (OR) 2.27; 95% confidence interval (CI), 1.06-4.87; P=.035), ICU admission (OR 3.42; 95% CI, 1.02-11.44; P=.046) and extracorporeal membrane oxygenation (OR 5.5; 95% CI, 1.01-30.13; P=.049) were independently associated with DVT. CONCLUSION/CONCLUSIONS:Given the high incidence of venous thromboembolic events in this population, we support the decision to empirically initiate therapeutic anticoagulation in patients with low bleeding risk and severe COVID-19 infection, with duplex ultrasonography reserved for patients with high clinical suspicion of VTE in which anticoagulation may pose a life-threatening consequence. Further study is warranted in patients with COVID-19 to elucidate the etiology of vascular thromboembolic events and guide prophylactic and therapeutic interventions in these patients.
PMCID:7543928
PMID: 33039545
ISSN: 2213-3348
CID: 4632272

Assessment of Quality of Life Changes in Lower Extremity Lymphedema Patients Using an Advanced Pneumatic Compression Device at Home

Maldonado, Thomas S; Rokosh, Rae S; Padberg, Frank; Rotella, Vittorio; Miller, Hyman; Nassiri, Naiem; Jacobowitz, Glenn; Berland, Todd; Sadek, Mikel; Barfield, Michael E
OBJECTIVE:Lymphedema is associated with significant morbidity and healthcare resource usage. Conventional therapy efficacy is limited with poor surgical salvage options. Preliminary studies demonstrated advanced pneumatic compression devices (APCD) improve clinical outcomes, however limited evidence regarding their role in healthcare cost mitigation or health-related quality of life (QOL) is available. METHODS:) between February 2016 and March 2019. Patients were assessed at baseline, 12, 24, and 52 weeks from enrollment by limb circumference, QOL assessments (Short Form-36 [SF-36] and Lymphedema Quality of Life [LYMQOL]), device compliance, cellulitic episodes and lymphedema-related health care use since the previous visit. Primary endpoints of interest were QOL at baseline compared to 12 weeks as well as unscheduled lymphedema-related clinic visits and hospital admissions at 52 weeks. Secondary endpoints included change in limb girth and QOL at 52 weeks compared to baseline. RESULTS:178 patients with LE lymphedema were prospectively enrolled; this interim report represents the first 74 subjects to complete 52 weeks of APCD treatment. The cohort was predominately male (94.6%), elderly (mean 67 years), obese (median BMI 32), and most commonly enrolled for treatment of phlebolymphedema (71.6%) with largely bilateral LE involvement (91.9%). There was no significant difference in QOL at 12 weeks. However, at 52 weeks, LYMQOL was significantly improved from baseline (6.3 vs. 7.4, p<0.0001) and SF-36 demonstrated significant improvement from baseline in the Physical Component (38.6 vs. 40.8; p=0.035) with an effect towards overall improvement as well in the Mental Component (49.9 vs. 51.3; p=0.549). Limb circumference was significantly reduced at 12 weeks from baseline (28.5cm vs. 27.7cm; p=0.0005) in the most affected LE, and this reduction remained stable for the study duration. APCD treatment was associated with a significant reduction in cellulitic incidence (24.3% vs. 8.1%, p=0.005), lymphedema-related clinic visits (2.2 vs. 0.7; p=0.02), urgent care visits (1.2 vs. 0.3; p=0.004), and hospital admissions (0.5 vs. 0.1; p=0.047) per patient. CONCLUSIONS:The FLX APCD results in initial significant limb girth reduction as early as 12 weeks and a steady sustained improvement in health-related QOL up to one year. The latter is likely reflective of a decrease in cellulitis episodes and fewer associated lymphedema-related clinic, urgent care visits and hospital admissions.
PMID: 33137494
ISSN: 2213-3348
CID: 4664032

Low-frequency avoidable errors during transcarotid artery revascularization

Teter, Katherine; Lamparello, Patrick J; Barfield, Michael; Rockman, Caron B; Macdonald, Sumaira; Maldonado, Thomas S
OBJECTIVE:Transcarotid artery revascularization (TCAR) seems to be a safe and effective alternative to carotid endarterectomy (CEA) and transfemoral carotid artery stenting (TF-CAS). The TCAR system represents a paradigm shift in the management of carotid artery stenosis with potential for a significant decrease in periprocedural morbidity. However, as with CEA or TF-CAS, TCAR is associated with infrequent complications related to user technical error, most of which are preventable. Our goal is to describe these low-frequency events, and to provide guidelines for avoiding them. METHODS:The U.S. Food and Drug Administration (FDA) requires that all medical device manufacturers create a system for receiving, reviewing, and evaluating complaints (Code 21 of Federal Regulations 820.198). Silk Road Medical, Inc (Sunnyvale, Calif), has established a process by which all feedback, including complaints that may not meet FDA criteria, is captured and stored in a database for detailed analysis. More than 13,300 cases have been performed; submitted complaints were reviewed for incidents of serious injury and periprocedural complications, above and beyond the device-related events that must be reported to the FDA. RESULTS:A total of 13,334 patients have undergone TCAR worldwide between early 2011 and December 2019 using the SilkRoad device. Reported complications included 173 dissections (1.4% overall rate) of the common carotid artery at the access point, of which 22.5% were managed without intervention or with medical therapy alone and 24.3% were converted to CEA (considered failing safely). Errors in the location of stent deployment occurred in 16 cases (0.13%), with the most common site being the external carotid artery (75%). One wrong side carotid artery stent was placed in a patient with a high midline pattern of the bovine arch. Cranial nerve injury was reported in 11 cases (0.08%), only one of which persisted beyond 3 months. There have been three reported pneumothoraces and one reported chylothorax. Many of these errors can be recognized and prevented with careful attention to detail. CONCLUSIONS:In high-risk patients requiring treatment for carotid artery stenosis, TCAR has been proven as an alternative to TF-CAS with an excellent safety profile. As with CEA or TF-CAS, this procedure has the potential for infrequent complications, often as a result of user technical error. Although significant, these events can be avoided through a review of the collective experience to date and recognition of potential pitfalls, as we have described.
PMID: 33065241
ISSN: 1097-6809
CID: 4798402

Adjunctive false lumen intervention for chronic aortic dissections is safe but offers unclear benefit

Rokosh, Rae S; Chen, Stacey; Cayne, Neal; Siracuse, Jeffrey J; Patel, Virendra I; Maldonado, Thomas S; Rockman, Caron B; Barfield, Michael E; Jacobowitz, Glenn R; Garg, Karan
OBJECTIVE:Adjunctive false lumen embolization (FLE) with thoracic endovascular aortic repair (TEVAR) in patients with chronic aortic dissection is thought to induce FL thrombosis and favorable aortic remodeling. However, these data are derived from small single-institution experiences and the potential benefit of FLE remains unproven. In this study, we examined perioperative and midterm outcomes of patients with aortic dissection undergoing concomitant TEVAR and FLE.* METHODS: Patients 18 or older who underwent TEVAR for chronic aortic dissection with known FLE status in the Society for Vascular Surgery Vascular Quality Initiative database between January 2010 and February 2020 were included. Ruptured patients and emergent procedures were excluded. Patient characteristics, operative details and outcomes were analyzed by group: TEVAR with or without FLE. Primary outcomes were in-hospital post-operative complications and all-cause mortality. Secondary outcomes included follow-up mean maximum aortic diameter change, rates of false lumen thrombosis, re-intervention rates, and mortality. RESULTS:884 patients were included: 46 had TEVAR/FLE and 838 had TEVAR alone. There was no significant difference between groups in terms of age, gender, comorbidities, prior aortic interventions, mean maximum pre-operative aortic diameter (5.1cm vs. 5.0cm, P=0.43), presentation symptomatology, or intervention indication. FLE was associated with significantly longer procedural times (178min vs. 146min, P=0.0002), increased contrast use (134mL vs. 113mL, P=0.02), and prolonged fluoroscopy time (34min vs. 21min, P<0.0001). However, FLE was not associated with a significant difference in post-operative complications (17.4% vs. 13.8%, P=0.51), length of stay (6.5 vs. 5.7 days, P=0.18), or in-hospital all-cause mortality (0% vs. 1.3%, P=1). In mid-term follow-up (median 15.5months, IQR 2.2-36.2 months), all-cause mortality trended lower, but was not significant (2.2% vs. 7.8%); and Kaplan-Meier analysis demonstrated no difference in overall survival between groups (P=0.23). By Cox regression analysis, post-operative complications had the strongest independent association with all-cause mortality (HR 2.65, 95% CI 1.56-4.5, P<0.001). In patients with available follow-up imaging and re-intervention status, mean aortic diameter change (n=337, -0.71cm vs. -0.69cm, P=0.64) and re-intervention rates (n=487, 10% vs. 11.4%, P=1) were similar. CONCLUSIONS:Adjunctive FLE, despite increased procedural times, can be performed safely for patients with chronic dissection without significantly higher overall perioperative morbidity or mortality. TEVAR/FLE demonstrates trends for improved survival and increased rates of FL thrombosis in the treated thoracic segment; however, given the lack of evidence to suggest a significant reduction in re-intervention rates or induction of more favorable aortic remodeling compared to TEVAR alone, the overall utility of this technique in practice remains unclear. Further investigation is needed to determine the most appropriate role for FLE in managing chronic aortic dissections.
PMID: 33838234
ISSN: 1615-5947
CID: 4889042

Histological Assessment of Lower Extremity Deep Vein Thrombi from Patients Undergoing Percutaneous Mechanical Thrombectomy

Yuriditsky, Eugene; Narula, Navneet; Jacobowitz, Glenn R; Moreira, Andre L; Maldonado, Thomas S; Horowitz, James M; Sadek, Mikel; Barfield, Michael E; Rockman, Caron B; Garg, Karan
BACKGROUND:Histological analyses of deep vein thrombi (DVT) are based on autopsy samples and animal models. No prior study has reported on thrombus composition following percutaneous mechanical extraction. As elements of chronicity and organization render thrombus resistant to anticoagulation and thrombolysis, a better understanding of clot evolution may inform therapies. METHODS:We performed histologic evaluation of DVTs from consecutive patients undergoing mechanical thrombectomy for extensive iliofemoral DVTs using the Clottriever/ Flowtriever device (Inari Medical, Irvine, CA). Thrombi were scored in a semi-quantitative manner based on the degree of fibrosis (collagen deposition on trichrome stain), and organization (endothelial growth with capillaries and fibroblastic penetration). RESULTS:Twenty-three specimens were available for analysis with 20 presenting with acute DVT (≤14 days from symptom onset). Eleven of 23 patients (48%) had >5% fibrosis (collagen deposition) and 14/23 patients (61%) had >5% organization (endothelial growth, capillaries, fibroblasts). Four patients with acute DVT had ≥25% organized thrombus and 2 had ≥ 25% collagen deposition. Among the 20 patients with acute DVT, 40% had >5% fibrosis and 55% had > 5% organization. Acuity of DVT did not correlate with the fibrosis or organizing scores. CONCLUSIONS:A large proportion of patients with acute DVT have histologic elements of chronicity and fibrosis. A better understanding of the relationship between such elements and response to anticoagulants and fibrinolytics may inform our approach to therapeutics.
PMID: 33836286
ISSN: 2213-3348
CID: 4839682

Closed Incision Negative Pressure Wound Therapy May Decrease Wound Complications in Major Lower Extremity Amputations

Chang, Heepeel; Maldonado, Thomas S; Rockman, Caron B; Cayne, Neal S; Berland, Todd L; Barfield, Michael E; Jacobowitz, Glenn R; Sadek, Mikel
OBJECTIVE:Wound complications after major lower extremity amputations are a cause of significant morbidity in vascular surgery patients. Recent publications have demonstrated the efficacy of the closed incision negative pressure dressing at preventing surgical site infections (SSIs); however, there are limited data on its use in major lower extremity amputations. This study sought to assess if closed incision negative pressure wound therapy (NPWT) would reduce the risk of complications as compared to a standard dressing in patients with peripheral vascular disease undergoing major lower extremity amputation. METHODS:system (Acelity L.P. Inc., San Antonio, TX, USA) was applied intraoperatively at the discretion of the operating surgeon and removed 5 to 7 days postoperatively. The standard group received a non-adherent dressing with an overlying compression dressing. Amputation incisions were assessed and wound complications were recorded. Student's t-test and two-sample proportion z-test were used for statistical analysis. A P value < .05 was considered statistically significant. RESULTS:For comorbidities, there was a higher incidence of tobacco use in the NPWT as compared to the standard group (44% vs. 13%; P = .011), as well as trends towards increased prior amputations, anemia, hyperlipidemia, and chronic obstructive pulmonary disorder in the NPWT group. For risk factors, there were more dirty wounds in the NPWT as compared to the standard group (52% vs. 26%; P = .046). For outcomes, there were fewer wound complications in the NPWT as compared to the standard group (13% vs. 39%; P = .037). The types of wound-related complications in the NPWT group included one wound dehiscence with a deep SSI, one superficial SSI and one incision line necrosis. In the standard group, there were 4 wound dehiscences with deep SSI, 3 superficial SSIs, 4 incision line necroses and 1 stump hematoma. The rates of perioperative mortality and amputation revision did not differ significantly between the NPWT and the standard group (3% vs. 4% and 4.3% vs. 10%, respectively). CONCLUSIONS:Closed incision negative pressure wound therapy may decrease the incidence of wound complications in vascular patients undergoing major lower extremity amputation. This held true even amongst a population that was potentially at higher risk. This therapy may be considered for use in lower extremity major amputations.
PMID: 32707380
ISSN: 1097-6809
CID: 4539842

Risk of thrombotic events after respiratory infection requiring hospitalization

Smilowitz, Nathaniel R; Subashchandran, Varun; Newman, Jonathan; Barfield, Michael E; Maldonado, Thomas S; Brosnahan, Shari B; Yuriditsky, Eugene; Horowitz, James M; Shah, Binita; Reynolds, Harmony R; Hochman, Judith S; Berger, Jeffrey S
Thrombosis is a major concern in respiratory infections. Our aim was to investigate the magnitude and duration of risk for arterial and venous thrombosis following discharge after respiratory infection. Patients with respiratory infections were identified using the United States Nationwide Readmission Database from 2012 to 2014. Patients admitted with asthma or cellulitis served as comparators. Readmissions for acute myocardial infarction (MI) and venous thromboembolism (VTE) were evaluated at 30 to 180 days. The likelihood of a first thrombotic event after discharge was compared with a 30-day period prior to hospitalization. Among 5,271,068 patients discharged after a respiratory infection, 0.56% and 0.78% were readmitted within 30-days with MI and VTE, respectively. Relative to asthma and cellulitis, respiratory infection was associated with a greater age and sex-adjusted hazard of 30-day readmission for MI (adjusted HR [aHR] 1.48 [95% CI 1.42-1.54] vs. asthma; aHR 1.36 [95% CI 1.31-1.41] vs. cellulitis) and VTE (aHR 1.28 [95% CI 1.24-1.33] vs. asthma; aHR 1.26, [95% CI 1.22-1.30] vs. cellulitis). Risks of MI and VTE attenuated over time. In a crossover-cohort analysis, the odds of MI (OR 1.68 [95% CI 1.62-1.73]) and VTE (OR 3.30 [95% 3.19-3.41]) were higher in the 30 days following discharge after respiratory infection than during the 30-day baseline period. Hospitalization for respiratory infection was associated with increased risks of thrombosis that were highest in the first 30-days after discharge and declined over time.
PMID: 33602977
ISSN: 2045-2322
CID: 4787172

Adjunctive False Lumen Intervention for Aortic Dissection Is Safe But Offers Unclear Benefit [Meeting Abstract]

Rokosh, R S; Cayne, N; Siracuse, J J; Patel, V; Maldonado, T; Rockman, C; Barfield, M E; Jacobowitz, G; Garg, K
Introduction and Objectives: Adjunctive false lumen embolization (FLE) with thoracic endovascular aortic repair (TEVAR) in patients with chronic aortic dissection is thought to induce FL thrombosis and favorable aortic remodeling. However, evidence is limited and the potential benefit of FLE remains unproven.
Method(s): Patients 18+ who underwent TEVAR for chronic aortic dissection with known FLE status in the SVS VQI database 1/2010-2/2020 were included. Ruptured patients and emergent procedures were excluded. Primary outcomes were in-hospital post-operative complications and all-cause mortality. Secondary outcomes included follow-up maximum aortic diameter change, re-intervention rates, and mortality.
Result(s): 884 patients were included: 46 had TEVAR/FLE and 838 had TEVAR alone. There was no significant difference between groups in terms of age, gender, comorbidities, maximum pre-operative aortic diameter, presentation symptomatology, or intervention indication. FLE was associated with significantly longer procedural times (178min vs. 146min, p=0.0002), increased contrast use (134mL vs. 113mL, p=0.02), and prolonged fluoroscopy time (34min vs. 21min, p<0.0001), but not associated with a significant difference in post-operative complications (17.4% vs. 13.8%, p=0.51), length of stay (6.5 vs. 5.7 days, p=0.18), or in-hospital all-cause mortality (0% vs. 1.3%, p=1). In mid-term follow-up (median 15.5months), all-cause mortality trended lower, but was not significant (2.2% vs. 7.8%); Kaplan-Meier analysis demonstrated no difference in overall survival between groups (p=0.23). Post-operative complications had the strongest independent association with all-cause mortality (HR 2.65, 95% CI 1.56-4.5, p<0.001). In patients with available follow-up imaging and re-intervention status, mean aortic diameter change (n=337, -0.71cm vs. -0.69cm, p=0.64) and re-intervention rates (n=487, 10% vs. 11.4%, p=1) were similar.
Conclusion(s): Adjunctive FLE can be performed safely in chronic thoracic aortic dissections without significantly higher perioperative morbidity or mortality. However, given lack of reduction in re-intervention rates, induction of significant favorable aortic remodeling, or definitive survival benefit compared to TEVAR alone, FLE utility remains unclear.
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EMBASE:2011052086
ISSN: 1615-5947
CID: 4811972