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Increased Aortic Sac Regression and Decreased Infrarenal Aortic Neck Dilation After Fenestrated Endovascular Aneurysm Repair Compared With Standard Endovascular Aneurysm Repair [Meeting Abstract]

Li, C; Teter, K; Rockman, C; Garg, K; Cayne, N; Veith, F; Sadek, M; Maldonado, T
Objective: Aortic neck dilation (AND) can occur in nearly 25% of patients after EVAR, resulting in loss of proximal seal and aortic rupture. Fenestrated endovascular aneurysm repair (FEVAR) affords increased treatment options for patients with shorter infrarenal aortic necks; however, AND has not been well characterized in these patients. This study sought to compare AND in patients undergoing FEVAR vs standard endovascular aneurysm repair (EVAR).
Method(s): Retrospective review was conducted of prospectively collected data of 20 consecutive FEVAR patients (Cook Zenith fenestrated; Cook Medical, Bloomington, Ind) and 20 EVAR patients (Cook Zenith). Demographic and anatomic characteristics, procedural details, and clinical outcome were analyzed. Preoperative, 1-month postoperative, and longest follow-up computed tomography scans were analyzed using a dedicated three-dimensional workstation. Abdominal aortic aneurysm (AAA) neck diameter was measured in 5-mm increments from the lowest renal artery. Standard statistical analysis was performed.
Result(s): Demographic characteristics did not differ significantly between the two cohorts. The FEVAR group had larger mean aortic diameter at the lowest renal artery, shorter infrarenal aortic neck length, increased prevalence of nonparallel neck shape, and longer AAA length (Table). On follow-up imaging, the suprarenal aortic segment dilated significantly more at all suprarenal locations in the FEVAR cohort, whereas the infrarenal aortic neck segment dilated significantly less compared with the EVAR group (Table). The FEVAR group demonstrated significantly greater sac regression vs the EVAR group. Positive aortic remodeling, as evidenced by increased distance from the celiac axis to the most cephalad margin of the AAA, occurred to a more significant degree in the FEVAR cohort. Device migration, endoleak occurrence, and need for reintervention were similar in both groups.
Conclusion(s): Compared with EVAR, patients undergoing FEVAR had greater extent of suprarenal AND, consistent with a more diseased native proximal aorta. However, the infrarenal neck, which is shorter and also more diseased in FEVAR patients, appears more stable in the postoperative period compared with EVAR cases. Moreover, the FEVAR cohort had significantly greater sac shrinkage and improved aortic remodeling. The suprarenal seal zone in FEVAR may confer a previously undescribed increased level of protection against infrarenal neck dilation and lessen endotension, resulting in more rapid and dramatic sac shrinkage and contributing to a more durable aortic repair. [Formula presented]
Copyright
EMBASE:2008357459
ISSN: 1097-6809
CID: 5184292

High Incidence of Patients Lost to Follow-up After Venous Thromboembolism Diagnosis-Identifying an Unmet Need for Targeted Transition of Care [Meeting Abstract]

Rokosh, R; Grazi, J; Ruohoniemi, D; Machhar, R; Sista, A; Jacobowitz, G; Rockman, C; Maldonado, T
Objective: Venous thromboembolism (VTE), including deep venous thrombosis (DVT) and pulmonary embolism (PE), affects approximately 5% of the population, and approximately 30% of affected individuals will die within 30 days of diagnosis. Given the prevalence of VTE and its associated mortality, our study evaluated the success of longitudinal treatment in patients diagnosed with VTE with particular attention to those lost to appropriate follow-up.
Method(s): This is a single-center retrospective study of all consecutive admitted (inpatient [IP]) and emergency department (ED) patients diagnosed with acute VTE by venous duplex ultrasound examination or chest computed tomography from January 2018 to March 2019. Patients with chronic DVT and those diagnosed in the outpatient setting were excluded. Data collected included age, sex, clinical setting at time of diagnosis, discharge anticoagulation choice, discharge disposition, and clinical follow-up. Lost to VTE follow-up (LTFU) was defined as those patients who did not follow up with vascular, cardiovascular, hematology/oncology, pulmonology, or primary care clinic for VTE management at our institution within 3 months after discharge. Patients discharged to hospice were excluded from LTFU analysis. Statistical analysis was performed using Stata 16 software (StataCorp LLC, College Station, Tex) and a threshold P value of <.05 set for significance.
Result(s): During the study period, 291 DVTs (237 lower extremity DVTs, 58 upper extremity DVTs, 4 mixed), 25 isolated PEs, and 55 PEs with associated DVT (53 lower extremity DVTs, 2 upper extremity DVTs) were identified in 371 patients. Of these patients, 130 (35%) were diagnosed in the ED and 241 (65%) in the IP setting. At discharge, 291 (78.4%) were receiving anticoagulation, 64 (17.3%) were not, and 16 (4.3%) were deceased. Ultimately, 133 patients (35.9%) were LTFU, 85% of whom were discharged on anticoagulation. There was no statistically significant difference between those LTFU with respect to age (P =.373), sex (P =.194), diagnosis time of day (P =.272), VTE type (P =.367), or discharge unit location (IP vs ED, 33.7% vs 43.8% LTFU; P =.114); however, there was a statistically significant association between longer IP length of stay and those patients LTFU in controlling for age (11.8 days vs 16.6 days; P =.028).
Conclusion(s): This study demonstrates that more than one-third of patients diagnosed with VTE at our institution are LTFU, suggesting that significant improvement could be achieved by establishing a pathway for the targeted transition of care to a VTE-specific follow-up clinic.
Copyright
EMBASE:2008357480
ISSN: 1097-6809
CID: 5184282

Increased Risk of Major Limb Events in Poor Clopidogrel Responders: Platelet Activity in Vascular Surgery and Cardiovascular Events (PACE) Study Subgroup Analysis [Meeting Abstract]

Tawil, M; Berger, J; Lamparello, P; Jacobowitz, G; Cayne, N; Sadek, M; Berland, T; Lugo, J; Rockman, C; Maldonado, T
Objective: Whereas clopidogrel is effective at decreasing cardiovascular events in patients with peripheral artery disease, a substantial number of events continue to occur. This study investigated the variability in response to clopidogrel and its relationship with clinical outcomes.
Method(s): There were 300 patients enrolled in the Platelet Activity in Vascular Surgery and Cardiovascular Events (PACE) study before lower extremity revascularization, of whom 119 were receiving clopidogrel. Platelet aggregation was measured in response to adenosine diphosphate (ADP) 2M immediately before revascularization. Patients were observed longitudinally for a median follow-up of 18 months. The primary end point was major adverse limb events (MALEs), defined by major amputation or reoperation of the affected limb. Patients were stratified into groups according to the percentage ADP-induced aggregation at 300 seconds (<50% aggregation, normal responder; >=50% aggregation, poor responder).
Result(s): Overall, the median age was 70 years (62-76 years), and 39.5% were female. Thirty-six (30.3%) patients had a MALE event (15 major amputation and 25 major reoperation); 60 patients underwent open or hybrid operations, and 50 patients underwent endovascular procedures. The remaining nine patients had no interventions. Of the group of 119 patients, 97 patients were taking aspirin. Overall, median aggregation to ADP 2M was 22.5% (Q1-Q3, 10%-50%), and 27 patients (26%) were clopidogrel nonresponders. Baseline aggregation was higher in patients who went on to develop a MALE than in those without a MALE (43% vs 20%; P =.018). Patients with aggregation > median (22.5%) were more likely to experience a MALE than were patients with aggregation < median (69% vs 31%; hazard ratio [HR], 2.71; 95% confidence interval [CI], 1.23-5.98; P =.013). After multivariable adjustment for age, sex, race/ethnicity, body mass index, diabetes, coronary artery disease, and aspirin, aggregation > median was associated with MALEs (adjusted HR, 2.67; 95% CI, 1.18-6.01; P =.018). When stratified by established cutoffs for responsiveness to clopidogrel (50% aggregation), 27 (26%) patients were poor responders. Poor responders were more likely to experience MALEs than normal responders (59% vs 41%; HR, 2.33; 95% CI, 1.11-4.89; P =.026). After multivariable adjustment, poor responder status trended toward an increased risk of MALE compared with a normal responder (adjusted HR, 2.18; 95% CI, 1.00-4.78; P =.051).
Conclusion(s): Among patients undergoing lower extremity revascularization, poor response to clopidogrel is associated with increased risk for major adverse limb events. Preoperative screening to ensure therapeutic clopidogrel response should be considered in these patients.
Copyright
EMBASE:2008357484
ISSN: 1097-6809
CID: 5184272

Evaluating time to treatment and in-hospital outcomes of pulmonary embolism response teams

Wiske, Clay P; Shen, Chen; Amoroso, Nancy; Brosnahan, Shari B; Goldenberg, Ronald; Horowitz, James; Jamin, Catherine; Sista, Akhilesh K; Smith, Deane; Maldonado, Thomas S
BACKGROUND:Pulmonary embolism response teams (PERTs) have become increasingly popular at institutions around the country, although the evidence to support their efficacy is limited. PERTs are mechanisms for rapid involvement of a multidisciplinary team in the management of a time-sensitive condition with many treatment options. METHODS:We retrospectively reviewed 201 patients with PERT activations since inception, collecting data on demographics, time to treatment, treatment modality, and in-hospital outcomes. RESULTS:Massive pulmonary embolism accounted for 16 (8.7%) PERT activations. The majority of patients were treated without invasive intervention; 91.4% (95% confidence interval [CI], 87.1%-95.7%) of patients received anticoagulation alone, 4.5% (95% CI, 0%-18.6%) had catheter-directed therapy (CDT), and 3.0% (95% CI, 0%-16.9%) had systemic administration of tissue plasminogen activator (tPA). The average time to intervention was 665 minutes (95% CI, 249-1080 minutes) for CDT and 22 minutes (95% CI, 0-456 minutes) for systemic TPA. The average time to anticoagulation was 2.3 minutes (95% CI, 0-43 minutes). There was a trend toward higher rates of cardiac events (odds ratio [OR], 12.68; 95% CI, 0.62-65.74) and death (OR, 3.19; 95% CI, 0.28-5.18) among patients with massive PE. There was a higher rate of cardiac events (OR, 5.66; 95% CI, 1.34-23.83) among patients who received tPA or an invasive intervention. There was no difference in mortality rates of patients who underwent aggressive management compared with anticoagulation alone. CONCLUSIONS:A dedicated PERT results in efficient delivery of care and excellent outcomes, in part owing to the rapid (on average, 8 minutes) time to initiation of a multidisciplinary discussion. Patients who ultimately underwent CDT had an interval of >10 hours on average between diagnosis and CDT. This provisional or delayed approach to CDT in selected patients who were not improving with anticoagulation alone (and therefore had potential for higher net benefit from a procedure with its own inherent risks) may have resulted in a lower rate of CDT.
PMID: 32179041
ISSN: 2213-3348
CID: 4352512

Arterial thromboembolism associated with COVID-19 and elevated D-dimer levels [Case Report]

Garg, Karan; Barfield, Michael E; Pezold, Michael L; Sadek, Mikel; Cayne, Neal S; Lugo, Joanelle; Maldonado, Thomas S; Berland, Todd L; Rockman, Caron B; Jacobowitz, Glenn R
The novel coronavirus 2019 (SARS-CoV-2) was first identified in January 2020 and has since evolved into a pandemic affecting >200 countries. The severity of presentation is variable and carries a mortality between 1% and 3%. We continue to learn about the virus and the resulting acute respiratory illness and hypercoagulability; however, much remains unknown. In our early experience in a high-volume center, we report a series of four cases of acute peripheral artery ischemia in patients with COVID-19 in the setting of elevated D-dimer levels.
PMCID:7297695
PMID: 32704579
ISSN: 2468-4287
CID: 4539752

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

Right ventricular stroke distance predicts death and clinical deterioration in patients with pulmonary embolism

Yuriditsky, Eugene; Mitchell, Oscar J L; Sista, Akhilesh K; Xia, Yuhe; Sibley, Rachel A; Zhong, Judy; Moore, William H; Amoroso, Nancy E; Goldenberg, Ronald M; Smith, Deane E; Brosnahan, Shari B; Jamin, Catherine; Maldonado, Thomas S; Horowitz, James M
PURPOSE/OBJECTIVE:The right ventricular outflow tract (RVOT) velocity time integral (VTI), an echocardiographic measure of stroke distance, correlates with cardiac index. We sought to determine the prognostic significance of low RVOT VTI on clinical outcomes among patients with acute pulmonary embolism (PE). MATERIALS AND METHODS/METHODS:We conducted a retrospective review of echocardiograms on Pulmonary Embolism Response Team (PERT) activations at our institution. The main outcome was a composite of death, cardiac arrest, or hemodynamic deterioration. RESULTS:Of 188 patients, 30 met the combined outcome (16%) and had significantly lower RVOT VTI measurements (9.0 cm v 13.4 cm, p < 0.0001). The AUC for RVOT VTI at a cutoff of 10 cm was 0.78 (95% CI 0.67-0.90) with a sensitivity, specificity, negative predictive value, and positive predictive value of 0.72, 0.81, 0.94, and 0.42, respectively. Fifty-two patients of the cohort were classified as intermediate-high-risk PE and 21% of those met the combined outcome. RVOT VTI was lower among outcome positive patients (7.3 cm v 10.7 cm, p = 0.02). CONCLUSIONS:Low RVOT VTI is associated with poor clinical outcomes among patients with acute PE.
PMID: 32652350
ISSN: 1879-2472
CID: 4527582

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