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Direct Oral Anticoagulants May Be Safe in Patients Undergoing Endovenous Radiofrequency and Laser Ablation

Chang, Heepeel; Sadek, Mikel; Barfield, Michael E; Rockman, Caron B; Maldonado, Thomas S; Cayne, Neal S; Berland, Todd L; Garg, Karan; Jacobowitz, Glenn R
OBJECTIVE:Studies assessing the effect of anticoagulants on endovenous thermal ablation (ETA) are limited to patients on warfarin. As such, the aim of this study was to assess the efficacy and safety of ETA in patients taking direct oral anticoagulants (DOACs). We hypothesized that the outcome of ETA in patients taking DOAC is not superior to the outcome in patients taking DOAC. METHODS:A retrospective review was performed to identify patients undergoing radiofrequency ablation (RFA) and endovenous laser ablation (EVLA) with 1470 nm diode laser fibers for symptomatic great or small saphenous venous reflux from 2018 to 2020. Patients were dichotomized into those receiving therapeutic dose of DOACs peri-procedurally and those not receiving anticoagulants (control). Outcomes of interest included the rates of treated vein closure at 7-days and 9-months, deep venous thrombosis (DVT), endothermal heat-induced thrombosis (EHIT) and bleeding peri-procedurally. RESULTS:There were 87 procedures performed in 69 patients receiving DOACs and 295 procedures in 232 control patients. Patients receiving DOACs were more often older (mean, 65 years vs 55 years; P<.001) and male (70% vs 37%; P<.001), with higher prevalence of venous thromboembolism and more severe CEAP classification (5 or 6), compared to control patients. Those receiving DOAC were more likely to have history of DVT (44% vs 6%; P<.001), PE (13% vs 0%; P<.001) and phlebitis (32% vs 15%; P<.001). Procedurally, RFA was used more frequently in the control group (92% vs 84%; P=.029), with longer segments of vein treated (mean 38 mm vs 35 mm, respectively; P=.028). No major or minor bleeding events nor any EHITs occurred in either group. Two patients (0.7%) in the control group developed DVT whereas no DVT was observed in the those receiving DOAC (P=.441). At 9-months, the treated vein remained ablated after 94.4% of procedures performed in patients receiving DOACs and 98.4% of controls (P=.163). On multivariable analysis, DOAC was not associated with an increased risk of vein recanalization (hazard ratio, 5.76; 95% confidence interval, 0.57-58.64; P=.139). An increased pre-procedural vein diameter and EVLA were associated with an increased risk of recanalization. CONCLUSION/CONCLUSIONS:In this study of patients undergoing ETA for symptomatic saphenous venous reflux, peri-procedural use of DOAC did not adversely affect the efficacy of endovenous ablation to at least 9-months. Furthermore, it did not confer additional risk of bleeding, DVT and EHIT peri-procedurally. As such, the early outcome of ETA in patients not taking DOAC may not be superior to the outcome in patients taking DOAC.
PMID: 35872143
ISSN: 2213-3348
CID: 5276102

Mid- and Long-Term Outcomes Following Dedicated Endovenous Nitinol Stent Placement for Symptomatic Iliofemoral Venous Obstruction: 3 to 5 Year Results of the VIRTUS Study

Razavi, Mahmood K; Gagne, Paul; Black, Stephen; Sadek, Mikel; Nicolini, Philippe; Weinberg, Ido; Marston, William
PURPOSE/OBJECTIVE:Assess the mid-term patency and long-term safety of dedicated venous stent placement to treat venous lesions of the iliofemoral outflow tract. MATERIALS AND METHODS/METHODS:Patients with unilateral obstructive disease of the iliofemoral veins and Clinical, Etiological, Anatomical, Pathophysiological (CEAP) Class ≥3 or Venous Clinical Severity Score ≥2 were enrolled in this prospective, multicenter, single arm study at 23 sites in the U.S.A. and Europe. Patients were followed for 36 months post index procedure for patency and up to 60 months for safety. Clinical outcomes for 11 patients with stent fracture were assessed. RESULTS:A total of 200 patients enrolled in two cohorts (i.e., Feasibility N=30, Pivotal N=170), were combined for this analysis. The 36-month primary patency rate was 71.7% (86/120) overall; and 96.4% (27/28) for the non-thrombotic group and 64.1% (59/92) for the post-thrombotic group, respectively. Freedom from major adverse events was 81.2% (53/65) through 60 months. The 60-month Kaplan-Meier estimate of freedom from target vessel revascularization was 84.3%. In 9 of the 11 patients who had stent fractures identified at 12-months (1 non-thrombotic, 10 post-thrombotic), stents extended into the common femoral vein. Target vessel revascularization rates and clinical outcomes among patients with or without stent fracture were similar. CONCLUSION/CONCLUSIONS:The VIRTUS results demonstrate good mid-term patency and long-term safety following placement of a dedicated venous stent for iliofemoral obstruction.
PMID: 36067976
ISSN: 1535-7732
CID: 5336982

Retro Jugular, Retro Sternocleidomastoid Approach for Subclavian Artery to Common Carotid Artery Bypass Using a Radial Artery Interposition Graft: 2-Dimensional Operative Video

Haynes, Joseph; Sadek, Mikel; Raz, Eytan; Levine, Jamie; Shapiro, Maksim; Delavari, Nader; Riina, Howard A; Nelson, Peter Kim; Favate, Albert; Nossek, Erez
PMID: 35972106
ISSN: 2332-4260
CID: 5299872

Extended Anticoagulation for Venous Thromboembolism: A Survey of the American Venous Forum and the European Venous Forum

Shaydakov, Maxim E; Ting, Windsor; Sadek, Mikel; Aziz, Faisal; Diaz, Jose A; Comerota, Anthony J; Lurie, Fedor; Blebea, John; Eklöf, Bo G; Lugli, Marzia; De Maeseneer, Marianne G R; Kakkos, Stavros K; Nicolaides, Andrew; Heim, Dominik; Welch, Harold J
OBJECTIVE:Extended anticoagulation should always be considered after standard treatment for an unprovoked episode of venous thromboembolism (VTE). It may also be considered in selected patients with provoked VTE. However, evidence-based protocols suggested by some clinical guidelines and risk assessment tools to guide this practice are limited and ambiguous. The goal of this survey research was to analyze current practices in applying extended anticoagulation therapy in patients with VTE among members of the American Venous Forum (AVF) and the European Venous Forum (EVF). METHODS:An online survey was created by the AVF Research Committee. The survey consisted of sixteen questions to identify the country of practice, specialty, experience of participating physicians, and their clinical practice patterns in applying extended anticoagulation in VTE patients. The survey was distributed over email to the members of the AVF and EVF. RESULTS:A total of 144 practitioners, 48 (33%) AVF members and 96 (66%) EVF members, participated in the survey. The majority of respondents identified themselves as vascular specialists with primary certification in vascular surgery (70%), vascular medicine/angiology (9%), and venous disease/phlebology (3%). Seventy-two percent of participants believe that the risk of VTE recurrence generally overweighs the risk of bleeding in patients with unprovoked VTE. Extended anticoagulation may be utilized by 97% of providers. Different patterns in real world clinical practice were identified. More than half of practitioners estimated VTE recurrence and bleeding risk subjectively. The antithrombotic drugs most commonly used for secondary prophylaxis were rivaroxaban, apixaban, warfarin, dabigatran, and aspirin, in decreasing order of frequency. Among the reasons selected for not considering extended anticoagulation on a regular basis were the lack of specific clinical practice guidelines (24%), the lack of published evidence (9%), and the absence of valid VTE/bleeding risk prediction calculators (8%). Twelve participants (8%) stated that extended anticoagulation was not beneficial for the majority of patients with VTE. Ten participants (7%) indicated that prescribing extended anticoagulation was outside the scope of their specialty. CONCLUSIONS:There are different practice patterns in extending anticoagulation beyond the standard treatment in patients with VTE. Major gaps in knowledge remain a serious challenge at least partially explaining inaccuracy and inconsistency in long-term VTE management. Appropriately designed studies are needed to evaluate risk stratification tools when contemporary best medical therapy is used, accurately predict VTE recurrence and its long-term outcomes, and to tailor safe and effective secondary prophylaxis.
PMID: 35561974
ISSN: 2213-3348
CID: 5215022

Severity of stenosis in symptomatic patients undergoing carotid interventions may influence perioperative neurologic events

Garg, Karan; Chang, Heepeel; Siracuse, Jeffrey J; Jacobowitz, Glenn R; Torres, Jose; Veith, Frank J; Patel, Virendra I; Maldonado, Thomas S; Sadek, Mikel; Cayne, Neal S; Rockman, Caron B
OBJECTIVE:Carotid artery plaque burden, indirectly measured by the degree of stenosis, quantifies future embolic risk. In natural history studies, patients with moderate degrees of stenosis have a lower stroke risk than those with severe stenosis. However, patients with symptomatic carotid stenosis who have experienced TIA or stroke are found to have both moderate and severe degrees of stenosis. We sought to examine the association carotid artery stenosis severity with outcomes in symptomatic patients undergoing carotid interventions including carotid endarterectomy (CEA), transfemoral carotid artery stenting (CAS) and transcervical carotid artery revascularization (TCAR). METHODS:The Society for Vascular Surgery Quality Initiative database was queried for all patients undergoing CAS, CEA and TCAR between 2003 and 2020. Patients were stratified into two groups based on the severity of stenosis - non-severe (0 - 69%) and severe (≥ 70%). Primary endpoints were periprocedural neurologic events (strokes and transient ischemic attacks (TIAs)). Secondary endpoints were periprocedural death, myocardial infarction (MI) and composite outcomes of stroke/death and stroke/death/MI per reporting standards for carotid interventions. RESULTS:Of 29,614 symptomatic patients included in the analysis, 5,296 (17.9%) patients underwent TCAR, 7,844 (26.5%) underwent CAS, and 16,474 (55.6%) underwent CEA for symptomatic carotid artery stenosis. In the CEA cohort, the neurologic event rate was similarly significantly lower in patients with severe stenosis when compared to those with non-severe stenosis (2.6% vs. 3.2%, P=.024). In the TCAR cohort, the periprocedural neurologic even rate was lower in patients with severe stenosis when compared to those with non-severe stenosis (3% vs. 4.3%, P=.033). There was no similar difference noted in the CAS cohort, with periprocedural neurologic event rates of 3.8% in the severe group versus 3.5% in the non-severe group (P=.518). On multivariable analysis, severe stenosis was associated with significantly decreased odds of post procedural neurologic events in patients undergoing CEA (odds ratio [OR] 0.75, 95% confidence interval [CI], 0.6 - 0.92; P=.007) and TCAR (OR .83; CI, .69 - 0.99; P=.039), but not CAS. CONCLUSION/CONCLUSIONS:Severe carotid stenosis as opposed to more moderate degrees of stenosis was associated with decreased rates of periprocedural stroke and TIAs in symptomatic patients undergoing TCAR and CEA, but not CAS. The finding of increased rates of periprocedural neurologic events in symptomatic patients with lesser degrees of stenosis undergoing TCAR and CEA warrants further evaluation with a particular focus on plaque morphology and brain physiology, and their inherent risks with carotid revascularization procedures.
PMID: 35272001
ISSN: 1097-6809
CID: 5183632

A Single-Center Experience of Anterior Accessory Saphenous Vein Endothermal Ablation Demonstrates Safety and Efficacy

Charitable, John; Speranza, Giancarlo; Rockman, Caron; Jacobowitz, Glenn; Kabnick, Lowell; Garg, Karan; Maldonado, Thomas; Berland, Todd; Cayne, Neal; Barfield, Michael; Sadek, Mikel
OBJECTIVE:Endothermal ablation is well established for the treatment of the great and small saphenous veins. Data are lacking for treatment of the Anterior Accessory Saphenous Vein (AASV). The purpose of this study is to evaluate the safety and efficacy of AASV treatment using endothermal ablation. METHODS:This was a retrospective review of 314 limbs at a single academic institution from 2016-2018 using the institutional Vascular Quality Initiative database. All limbs had documented AASV reflux. Baseline characteristics were evaluated including age, sex, ethnicity, CEAP (clinical, etiology, anatomy, pathophysiology) classification, Venous Clinical Severity Score (VCSS), and vein diameter. Outcomes relating to procedure safety and efficacy included treatment modality and length, successful ablation on post-operative imaging, post-procedural clinical outcomes, incidence of endothermal heat induced thrombosis (EHIT), and any post-procedural complication. RESULTS:A total of 314 consecutive limbs were identified from 2016-2018. Pre-procedure VCSS scores were available for 312 limbs and averaged 6.13 ± 3.33. History of varicose veins were reported in all limbs with 49.4% (n=155) having previously undergone a procedure. The most common presenting symptom was mild edema in 52.5% (n=165). Vein diameter and assessment of reflux were obtained by venous duplex ultrasound (DUS). The largest AASV diameter was available for 304 limbs, averaging 7.93 ± 2.69 mm. Treatment modalities included radiofrequency ablation (RFA) in 59.2% (n=186), endovenous laser ablation (EVLA) in 37.9% (n=119), and isolated microphlebectomy in 2.9% (n=9). 38.5% (N=121) of limbs underwent concomitant microphlebectomy at the time of EVLA. Total treatment length was obtained in 297 limbs, averaging 23.0 cm ± 12.0. Post-operatively, 94.6% (n=297) of limbs were prescribed compression stockings. Post-operative DUS was performed in 312 limbs, revealing successful ablation in 96.5% (n=303) with 2 limbs (0.6%) developing an EHIT, both treated with therapeutic enoxaparin for one week. Repeat DUS revealed thrombus resolution in one limb, while the other patient was lost to follow-up. VCSS scores post-procedure were available for 145 limbs and averaged 4.45 ± 2.31. This was a statistically significant decrease from pre-procedure VCSS scores (p<0.01). Average duration of follow-up was 2.2 years, with two limbs lost to follow-up. Of the 9 limbs (3.5%) whose initial procedure failed, 5 (56%) were treated using RFA and 4 (44%) were treated using EVLA. There were no other post-operative complications. CONCLUSION/CONCLUSIONS:Our experience over a three-year period for treating the AASV shows it to be safe and effective in a broad range of disease severity with an improvement in VCSS and a low incidence of EHIT. Additionally, RFA and EVLA exhibit similar treatment efficacy. Long-term follow-up data are needed.
PMID: 35218957
ISSN: 2213-3348
CID: 5172682

Young Patients Undergoing Carotid Endarterectomy Have Increased Rates of Recurrent Disease and Late Neurologic Events [Meeting Abstract]

Garg, K; Chang, H; Sadek, M; Maldonado, T; Cayne, N; Barfield, M; Siracuse, J; Jacobowitz, G; Rockman, C
Background: There is a paucity of data regarding outcomes of patients with premature cerebrovascular disease (<=55 years) who undergo carotid endarterectomy (CEA). The objective of this study was to analyze demographics, presentation, perioperative, and later outcomes of younger patients undergoing CEA.
Method(s): The Society for Vascular Surgery Vascular Quality Initiative was queried for CEA cases (2003-2020). Patients were stratified based on age 55 years or less or greater than 55 years. Primary end points were periprocedural stroke, death, myocardial infarction, and composite outcomes. Secondary end points analyzed included ipsilateral restenosis (>=80%) or occlusion, late ipsilateral neurologic events, and reintervention.
Result(s): Of 144,416 patients undergoing CEA, 8264 (5.7%) were aged 55 years or younger. The mean age was 51.3 years (range, 36 to 55 years). Younger patients were more likely to be female (44.5% vs 39.1%) and to be current smokers (58.8% vs 24.4%) (P <.001). They were less likely than older patients to have hypertension (82.2% vs 89.7%), coronary artery disease (25.6% vs 27.9%), and congestive heart failure (7.6% vs 11.2%; P <.001). Younger patients were less likely than older patients to be on aspirin, statins, or beta-blockers, but were more likely to be on P2Y12 inhibitors (P <.001). Younger patients were more likely to present with symptomatic disease (59% vs 47.2%) and were more likely to undergo nonelective CEA (19.3% vs 12.7%; P <.001). Younger patients had similar rates of perioperative stroke/death (1.8% vs 1.9%) and postoperative neurological events (1.7% vs 1.7%), but had lower rates of overall postoperative complications (3.8% vs 4.8%; P <.001). Sixty percent of patients had recorded follow-up (mean, 13 months). During follow-up, younger patients were significantly more likely than older patients to experience complete occlusion or significant (>=80%) restenosis of the operated artery (2.3% vs 1.6%), and were more likely to experience an ipsilateral neurological event (1.4% vs 0.9%) or any neurological event (3.2% vs 2.2%; P <.001).
Conclusion(s): Young patients undergoing CEA are more likely to be female, active smokers, and symptomatic. Although perioperative outcomes are similar, younger patients are more likely to experience carotid occlusion or restenosis as well as subsequent neurological events, during relatively short follow-up. These data suggest that younger CEA patients require more diligent follow-up, and a continued aggressive approach to medical management of atherosclerosis to prevent future events related to the operated artery.
Copyright
EMBASE:2019819768
ISSN: 1097-6809
CID: 5512732

Patients With Carotid Occlusion Require Close Surveillance and Have a High Rate of Subsequent Carotid Intervention [Meeting Abstract]

Speranza, G; Harish, K; Rockman, C; Gordon, R; Sadek, M; Jacobowitz, G; Chang, H; Garg, K; Maldonado, T S
Objective: There is a paucity of literature on the natural history of extracranial carotid artery occlusion (CAO). This study reviews the natural history of this patient cohort.
Method(s): This single-institution retrospective analysis studied patients with CAO diagnosed by duplex ultrasound test between 2010 and 2021. Patients were identified by searching our office-based accredited vascular laboratory database. Imaging and clinical data were obtained via our institutional electronic medical record.
Result(s): A total of 5523 patients underwent carotid artery duplex examination during the study period. The CAO cohort consisted of 140 patients, as characterized in Table I; incidence of CAO was 2.5%. A total of 61.3% (n = 86) of patients were asymptomatic at diagnosis. A total of 27.9% (n = 39) were diagnosed after a stroke or transient ischemic attack, with 16.4% ipsilaterally affected, 7.9% contralaterally affected, and 3.6% with unclear laterality. For 23 patients with prior duplex imaging demonstrating ipsilateral patency, 26.1% had <50% ipsilateral stenosis, 39.1% had 50%-69% stenosis, and 26.1% had >70% stenosis at a mean of 32.8 +/- 26.4 months before CAO diagnosis. At CAO diagnosis, 55.2% of patients had <50% contralateral stenosis, 24.8% had 50%-69% stenosis, and 9.9% had >70% stenosis. Ninety-five patients (67.9%) had duplex imaging follow-up (mean: 42.7 +/- 31.3 months). Six patients (6.3%) developed recanalization with the mean occurrence of 42.9 +/- 32.6 months after diagnosis. Four patients (2.9%) developed subsequent stroke ipsilateral to the CAO with the mean occurrence of 27.8 +/- 39.0 months after diagnosis. Thirteen patients (9.3%) developed other related symptoms, including global hypoperfusion (5.0%), cognitive changes (2.9%), and transient ischemic attack (1.4%). Ten patients (7.1%) underwent eventual ipsilateral intervention, including carotid endarterectomy (n = 6), transfemoral carotid artery stenosis (n = 2), transcarotid artery revascularization (n = 1), and carotid bypass (n = 1), with the mean occurrence of 17.7 +/- 23.7 months after diagnosis. Before intervention, seven occlusions on duplex imaging were recharacterized as severe stenosis per periprocedural CT or MR imaging. Two CAOs were intervened on subsequent to recanalization. One patient with confirmed CAO underwent bypass for symptoms of global cerebral hypoperfusion. Intervention characteristics are shown in Table II. The aggregate rate of developing recanalization, related stroke or symptoms, or undergoing ipsilateral intervention was 19.3%. A total of 16 patients (11.4%) underwent contralateral intervention, including carotid endarterectomy (8.6%), transcarotid artery revascularization (2.1%), and transfemoral carotid artery stenosis (0.7%), with the mean occurrence of 11.5 +/- 18.2 months after diagnosis.
Conclusion(s): In this large, institutional cohort of patients with CAO diagnosed by duplex ultrasound test, a clinically meaningful subset of patients experienced recanalization, stroke, or related symptoms. Most patients with CAO per duplex ultrasound test who underwent intervention were subsequently recharacterized as having severe stenosis. These data suggest that patients with CAO may benefit from aggressive medical management, close follow-up, and confirmatory imaging. [Formula presented] [Formula presented]
Copyright
EMBASE:2018189626
ISSN: 1097-6809
CID: 5291192

Response to clopidogrel in patients undergoing lower extremity revascularization

Tawil, Michael; Maldonado, Thomas S; Xia, Yuhe; Berland, Todd; Cayne, Neal; Jacobowitz, Glenn; Lugo, Joanelle; Lamparello, Patrick; Sadek, Mikel; Rockman, Caron; Berger, Jeffrey S
OBJECTIVES/OBJECTIVE:Clopidogrel is effective at decreasing cardiovascular events in patients with peripheral artery disease (PAD); however, its effect on limb outcomes are less known. This study investigated the variability in response to clopidogrel and its relationship with clinical limb outcomes. METHODS: RESULTS: CONCLUSIONS:Among patients undergoing lower extremity revascularization on clopidogrel, higher baseline percent aggregation is associated with increased risk for major adverse limb events.
PMID: 35590464
ISSN: 1708-539x
CID: 5284322

Natural History of Incidentally Noted Celiac Artery Aneurysms [Meeting Abstract]

Hartwell, C A; Johnson, W; Nwachukwu, C; Garg, K; Sadek, M; Maldonado, T S; Jacobowitz, G R; Kim, D; Rockman, C
Objective: Celiac artery aneurysms (CAAs) are unusual. The reported literature is skewed toward those treated by operative or endovascular intervention. The goal of the present study was to investigate the natural history of untreated CAAs.
Method(s): We performed a single-institution retrospective analysis of patients with CAAs diagnosed by computed tomography from 2015 to 2019. The patients were identified by searching our institutional radiology database. The radiologic, demographic, and follow-up clinical and imaging data were obtained from the electronic medical records.
Result(s): The analyzed cohort consisted of 76 patients (86.8% were men). The mean age was 69.8 years (range, 29-93 years). The medical comorbidities included hypertension (64.5%), diabetes (9.2%), coronary disease (18.4%), and hypercholesterolemia (46.1%). Concomitant vascular disease was noted and included AAA in 13.2%, an additional visceral aneurysm in 10.5%, and a visceral artery anomaly in 11.8%. The mean CAA diameter at the index study was 15.4 mm (range, 7-30 mm). Most (97.3%) were believed to be true aneurysms. Additional characteristics included thrombus (9.2%), calcification (26.3%), and dissection (11.8%). Of the 76 patients, 45 (59.2%) had had follow-up imaging data available for analysis. The mean clinical follow-up time was 31.2 months. The follow-up time for only those with subsequent imaging studies available was 25.2 months. During this period, 16 CAAs (21.1%) had enlarged in size and 29 (79.9%) had remained stable. No patient had developed symptoms or rupture. One patient (1.3%) had undergone intervention for an increasing size in the setting of chronic dissection. On univariate analysis, the only factor that was significantly associated with an increased risk of growth was younger age (mean age at diagnosis, 63.4 years vs 74.3 years; P =.005). We could not identify any other factor that was significantly predictive of, or protective against, aneurysm growth. For patients with follow-up imaging studies available, the freedom from aneurysm growth or intervention was 63% at 37 months. For the entire cohort, the freedom from aneurysm rupture or the need for intervention was 90% at 59 months.
Conclusion(s): The results from the present large study of patients with untreated CAAs revealed that very few lesions either enlarged to a clinically meaningful degree, became symptomatic, or required intervention during a 31.2-month follow-up period. Guidelines that suggest repair of CAAs >=2 cm in diameter might be overly aggressive. Close follow-up with serial imaging studies, especially for patients who are younger at diagnosis, might be preferred for most patients with an incidentally noted true CAA.
Copyright
EMBASE:2016861786
ISSN: 1097-6809
CID: 5157942