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Incidence of Acute and Chronic Renal Failure Following Branched Endovascular Repair of Complex Aortic Aneurysms
Lommen, Matthew J; Vogel, Jack J; VandenHull, Angela; Reed, Valerie; Pohlson, Kathryn; Answini, Geoffrey A; Maldonado, Thomas S; Naslund, Thomas C; Shames, Murray L; Kelly, Patrick W
BACKGROUND:The purpose of this study was to examine the incidence of acute kidney injury and chronic renal impairment following branched endovascular aneurysm repair (BEVAR) of complex thoracoabdominal aortic aneurysms (TAAA) using the Medtronic Valiant Thoracoabdominal Aortic Aneurysm stent graft system (MVM), the physician-modified Visceral Manifold, and Unitary Manifold stent graft systems. The objective was to report the acute and chronic renal function changes in patients following complex TAAA aneurysm repair. METHODS:This is an analysis of 139 patients undergoing branched endovascular repair for complex TAAAs between 2012 and 2020. Patient renal function was evaluated using serum creatinine and estimated glomerular filtration rate at baseline, 48 hr, discharge, 1 month, 6 months, and annually to 2 years. Patients on dialysis prior to the procedure were excluded from data analysis. RESULTS:A total of 139 patients (mean age 71.13; 64.7% male) treated for TAAA with BEVAR met inclusion criteria and were evaluated. A total of 530 visceral vessels were stented. A majority of patients (n = 131, 94.2%) underwent a single procedure while 8 required staged procedures. Thirty-day, 1-year and 2-year all-cause mortality rates were 5.8%, 25.2%, and 32.4%, respectively. Primary and secondary patency rates at a median follow-up of 26.9 months (95% CI; 21.1 - 32.7) were 96.2% and 97.5% for all vessels and 95.4% and 96.9% for renal arteries, respectively. Postoperative acute kidney injury (AKI) was identified in 22 (15.8%) patients. At discharge, 16 patients (11.6%) had an increase in CKD stage with 3 requiring permanent dialysis. Five additional patients required permanent dialysis over the 2-year follow-up period for a total of 8 (5.8%). Increasing age (HR = 1.0327, P= 0.0477), hemoglobin < 7 prior to procedure (HR = 2.4812, P= 0.0093), increasing maximum aortic diameter (HR = 1.0189, P= 0.0084), presence of AKI (HR = 2.0757, P= 0.0182), and increase in CKD stage (HR = 1.3520, P= 0.002) at discharge were significantly associated with decreased patient survival. CONCLUSIONS:Postoperative AKI and a chronic decline in renal function continue to be problematic in endovascular repair of complex aortic aneurysms. This study found that BEVAR using the manifold configuration resulted in immediate and mid-term renal function that is comparable to similar analyses of branched and/or fenestrated grafts.
PMID: 34182119
ISSN: 1615-5947
CID: 4965012
Multi-institutional Patterns of Clopidogrel Response Among Patients Undergoing Transcarotid Artery Revascularization [Meeting Abstract]
Rokosh, R S; Rockman, C B; Ehlert, B A; Wang, S K; Motaganahalli, R L; Schroeder, A C; Sobraske, P J; Stoner, M C; Tarbunou, Y A; Marmor, R A; Malas, M B; Maldonado, T S
Objectives: Current guidelines recommend dual antiplatelet therapy (DAPT) in patients undergoing carotid artery stenting. The most common DAPT regimen is aspirin and clopidogrel, a P2Y12 receptor antagonist; however, there is evidence that the prevalence of clopidogrel resistance (CR) in patients undergoing percutaneous coronary interventions may exceed 40%. Few studies have investigated the prevalence and impact of CR in patients undergoing extracranial carotid artery stenting, particularly transcarotid artery revascularization (TCAR).
Method(s): Consecutive patients 18 years and older who underwent TCAR for high grade (>80%) or symptomatic (>50%) carotid stenosis with preoperative P2Y12 testing between January 2018 and January 2021 were identified across six institutions. Preoperative platelet reactivity was measured with the light transmission aggregometry (VerifyNow P2Y12 Reaction Units [PRU] Test; Instrumentation Laboratory, Bedford, MA), with CR defined as PRU >=194 and hyper-responders as PRU <70. Patients without preoperative P2Y12 testing within 30 days prior to TCAR or those on a non-clopidogrel P2Y12 inhibitor preoperatively were excluded. Primary outcome of interest was the prevalence of CR. Secondary outcomes included the incidence of ischemic and hemorrhagic complications.
Result(s): Of the 67 patients identified, 60 met inclusion criteria. The cohort was 63% male (38/60) and 62% (37/60) Caucasian, with mean age of 74 years (+/-8; range, 56-92 years). Preoperatively, 95% of patients were on aspirin, 100% on clopidogrel, and 15% on therapeutic anticoagulation. At presentation, 42% (25) were symptomatic. Mean preoperative P2Y12 was 168 PRU (+/-81; range, 6-349 PRU). In total, 23 patients (38%) met criteria for CR (mean PRU, 249 +/- 43; range, 197-349), and 8 patients (13%) met criteria for hyper-responder (mean PRU, 35 +/- 22; range, 6-64). There was no significant difference between clopidogrel responders and patients with CR in terms of age (P =.1447), gender (P = 1), race (P =.387), or symptomatic presentation (P =.319). Postoperatively, there were no in-hospital transient ischemic attacks, strokes, or myocardial infarctions. Two patients (3%), one CR (PRU, 240) and one responder (PRU, 119), experienced postoperative access site hematomas that required no subsequent intervention; no other index hospitalization hemorrhagic complications occurred.
Conclusion(s): Using preoperative P2Y12 testing with a threshold of PRU >=194 to define CR, we identified a high prevalence of CR in patients undergoing TCAR similar to that in the pre-existing coronary literature. We found no significant differences in postoperative ischemic or hemorrhagic complications by clopidogrel response phenotype, although complication rates in the overall study cohort were low. Further investigation is warranted to determine if a quantitative assessment of CR is sufficient to identify patients at risk of developing secondary cerebrovascular ischemic events in this patient population.
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EMBASE:2014098041
ISSN: 1097-6809
CID: 5177312
Statin Use Reduces Mortality in Patients Who Develop Major Complications After Transcarotid Artery Revascularization [Meeting Abstract]
Chang, H; Rockman, C B; Jacobowitz, G R; Veith, F J; Sadek, M; Kashyap, V S; Maldonado, T S
Objective: Statins are often used for primary and secondary prevention of cardiovascular events. Multiple studies have demonstrated a significant reduction in perioperative complications after carotid endarterectomy for patients taking statins. However, data for statin use for patients undergoing transcarotid artery revascularization (TCAR) are limited. We evaluated the effects of statin use on the postoperative outcomes after TCAR.
Method(s): The records of the Vascular Quality Initiative carotid artery stenting registry (2012-2020) were reviewed for patients who had undergone TCAR. The patient demographics, perioperative characteristics, and 30-day outcomes were compared between the patients treated with and without statins (statin and no-statin group, respectively). Multivariable logistic regression models were used to estimate the effect of statins on the postoperative outcomes.
Result(s): A total of 15,797 patients had undergone TCAR, of whom, 10,116 (64%) were men. Of the 15,797 patients, 14,152 (89.6%) were taking a statin preoperatively (Table I). The statin group was more likely to have hypertension (91% vs 87%; P <.001), coronary artery disease (26% vs 23%; P =.008), and diabetes mellitus (33% vs 29%; P <.001). The incidence of both prior ipsilateral stroke (17.2% vs 13.5%; P <.001) and recent ipsilateral stroke (<=30 days; 7.1% vs 5.6%; P =.02) was higher in the statin group. No differences were found in the perioperative characteristics, including median operative time, contrast amount used, technical success, and number of stents used. Perioperative stroke and major adverse cardiac events (MACE; myocardial infarction, congestive heart failure, dysrhythmia) occurred in 1.5% and 2.4% of the statin group and 1.4% and 2.3% of the no-statin group, respectively. Controlling for covariates with the logistic regression method, statin use was associated with a 62% reduction in the odds of mortality (odds ratio, 0.38; 95% confidence interval, 0.19-0.99; P =.047; Table II) for patients who had experienced a perioperative stroke or MACE after TCAR.
Conclusion(s): Statin use was associated with a significant reduction in postoperative mortality for patients who had experienced a stroke or MACE after TCAR. Therefore, strict adherence to statin use is strongly recommended, especially for patients who could be at high risk of major postoperative complications. [Formula presented] [Formula presented]
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EMBASE:2014097723
ISSN: 1097-6809
CID: 5177152
The Degree of Carotid Artery Stenosis Affects the Perioperative Stroke Rate in Symptomatic Patients Undergoing Carotid Intervention [Meeting Abstract]
Garg, K; Jacobowitz, G R; Veith, F J; Patel, V I; Siracuse, J J; Maldonado, T S; Sadek, M; Cayne, N S; Rockman, C B
Objectives: In patients with carotid stenosis, both the severity of the stenosis as well as the plaque morphology influence the likelihood of future transient ischemic attack or stroke. In general, severely stenotic lesions are presumed to have a higher embolic potential than moderately stenotic lesions. Carotid intervention is indicated in patients with both moderate and severe stenosis with related cerebrovascular symptoms. However, the effect of the degree of carotid stenosis in symptomatic patients upon the outcome of carotid intervention has not been extensively studied.
Method(s): The Society for Vascular Surgery Quality Initiative database was queried for all patients undergoing transfemoral carotid stenting (CAS), carotid endarterectomy (CEA), and transcervical carotid stenting (TCAR) between 2003 and 2020. Patients undergoing interventions for symptomatic disease were included in the analysis. Patients were stratified into two cohorts based on the severity of stenosis-moderate (0%-69%) and severe (greater than or equal to 70%). Primary endpoints were perioperative neurologic events (strokes and transient ischemic attacks [TIAs]). Secondary endpoints were perioperative mortality and postoperative complications.
Result(s): Over 50,000 patients were included in the analysis: 5296 patients (8.9%) underwent TCAR, 7844 (13.3%) underwent CAS, and 45,853 (77.8%) underwent CEA for symptomatic carotid artery disease. In the TCAR and CEA cohorts, patients with moderate stenosis had a significantly higher rate of perioperative neurologic events than patients with severe stenosis (TCAR 4.3% vs 3.0%; P =.033; CEA 3.0% vs 2.3%; P <.001). In contrast, in patients undergoing CAS, there was no significant difference noted in the perioperative neurologic event rate (3.5% in moderate stenosis group vs 3.8% in severe stenosis group; P =.518). There were no differences in perioperative myocardial infarction or mortality (Table). On multivariable analysis, moderate stenosis was significantly and independently associated with an increased rate of neurologic events in the TCAR (odds ratio [OR], 0.833; 95% confidence interval, 0.693-1.000; P =.05), and CEA (odds ratio, 0.901; 95% confidence interval, 0.861-0.944; P <.001) cohorts.
Conclusion(s): Moderate carotid stenosis was associated with increased perioperative neurologic events in patients undergoing TCAR and CEA, but not CAS. Therefore, this effect was noted only in the cohorts that require direct open surgical manipulation of the cervical carotid artery (TCAR and CEA). Moderately stenotic lesions that become symptomatic likely have worse intrinsic plaque morphology than severely stenotic lesions, producing cerebrovascular symptoms at a lower degree of stenosis. The mechanism of such events warrants further evaluation with a particular focus on plaque morphology and brain physiology. [Formula presented]
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EMBASE:2014097884
ISSN: 1097-6809
CID: 5177322
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
High incidence of patients lost to follow-up after venous thromboembolism diagnosis - Identifying an unmet need for targeted transition of care
Rokosh, Rae S; Grazi, Jack H; Ruohoniemi, David; Yuriditsky, Eugene; Horowitz, James; Sista, Akhilesh K; Jacobowitz, Glenn R; Rockman, Caron; Maldonado, Thomas S
OBJECTIVES/OBJECTIVE:Venous thromboembolism, including deep venous thrombosis and pulmonary embolism, is a major source of morbidity, mortality, and healthcare utilization. Given the prevalence of venous thromboembolism and its associated mortality, our study sought to identify factors associated with loss to follow-up in venous thromboembolism patients. METHODS:-value of <0.05 set for significance. RESULTS: = 0.03) as opposed to home. CONCLUSIONS:Our study demonstrates that over one-third of patients diagnosed with venous thromboembolism at our institution are lost to venous thromboembolism-specific follow-up, particularly those discharged to a facility. Our work suggests that significant improvement could be achieved by establishing a pathway for the targeted transition of care to a venous thromboembolism-specific follow-up clinic.
PMID: 34080914
ISSN: 1708-539x
CID: 4891752
The Use of Gore C-TAG with Active Control to Treat A Complex Infrarenal Abdominal Aortic Aneurysm [Case Report]
Charitable, John F; Li, Chong; Maldonado, Thomas S
Complex abdominal aortic aneurysms (AAAs) can preclude endovascular aortic repair. In patients unable to undergo open surgical repair (OSR), using endografts outside the Instructions for Use (IFU) may be the only option. We present the case of a woman with a highly angulated infrarenal AAA neck who was unsuitable for OSR and successfully treated using a Gore TAG Conformable Thoracic Stent Graft with Active Control, Medtronic Heli-FX EndoAnchors, and bifurcated Gore Excluder endoprosthesis. The repair was successful without evidence of endoleak. Using a thoracic endograft off IFU to treat infrarenal AAAs may be feasible for patients unable to undergo OSR.
PMID: 33157188
ISSN: 1097-6809
CID: 4664522
Management of inferior vena cava thrombosis with the FlowTriever and ClotTriever systems
Shah, Noor G; Wible, Brandt C; Paulisin, Joseph A; Zaki, Mina; Lamparello, Patrick; Sista, Akhilesh; Sadek, Mikel; Jacobowitz, Glenn R; Maldonado, Thomas S
OBJECTIVE:Although inferior vena cava (IVC) thrombosis is infrequently encountered, it carries a significant risk of post-thrombotic syndrome and pulmonary embolus. Recent studies show no difference in the incidence of post-thrombotic syndrome in patients with iliofemoral deep venous thrombosis (DVT) treated with pharmacothrombolysis vs anticoagulation alone; however, there is an associated increased risk of bleeding. The treatment of IVC thrombosis is less well-studied and the hemodynamic changes may be more significant with pharmacothrombolysis, although the bleeding risk remains. The ClotTriever and FlowTriever systems remove thrombus from veins without the use of thrombolytics. Our study evaluates outcomes of patients undergoing mechanical thrombectomy for the treatment of IVC thrombosis using the ClotTriever and FlowTriever devices. METHODS:A retrospective chart review was performed to identify consecutive patients who underwent mechanical thrombectomy for the treatment of IVC thrombosis using the ClotTriever and/or FlowTriever systems from November 2018 to January 2020 at four data-sharing institutions. The decision of which device(s) to use was at the discretion of the surgeon. Patient demographics, symptomatology, and imaging characteristics were captured at presentation and follow-up. RESULTS:A total of 15 patients met the inclusion criteria; 10 were male, and the average age was 59 years. The majority of patients were symptomatic at presentation (n = 14), had a prior history of DVT (n = 13), and had a preexisting IVC filter (n = 8). Eleven patients presented with acute onset (<1 week) of symptoms, whereas three patients had subacute (1-4 weeks) symptoms. Most patients had an associated iliofemoral DVT (n = 13) and were treated with both ClotTriever and FlowTriever (n = 8); others were treated with either ClotTriever or FlowTriever alone (n = 5 and n = 2, respectively). Technical success was achieved in all but two patients, one who had a nonocclusive thrombus densely adherent to a preexisting IVC filter and another who had a chronic rubbery clot in the IVC that could not be cleared. No patient required concomitant lytic therapy or a postoperative stay in the intensive care unit. Furthermore, there were no postoperative bleeding events, myocardial infarctions, pulmonary emboli, renal impairments, or deaths. The median length of stay was 3 days (range, 1-37 days). Patients underwent postoperative follow-up (n = 7) as well as extended follow-up (>6 months; n = 8). All patients who achieved technical success were asymptomatic without evidence of reocclusion of the IVC on follow-up imaging. CONCLUSIONS:In our multicenter series of 15 patients, The ClotTriever and FlowTriever showed promise in the treatment of IVC thrombosis without the use of fibrinolytic drugs, with no bleeding events and no requirement for intensive care unit stay.
PMID: 33045392
ISSN: 2213-3348
CID: 4663452
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