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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

Common iliac vein stenting for May-Thurner syndrome and subsequent pregnancy

Speranza, Giancarlo; Sadek, Mikel; Jacobowitz, Glenn
BACKGROUND:For women with left common iliac vein compression (ie, May-Thurner syndrome) who undergo venous stenting and subsequently become pregnant, concerns have been raised regarding a possible compromise of stent patency due to compression from the gravid uterus and the hypercoagulability induced by pregnancy. Only a small body of literature exists on this subject, and limited management guidelines are available. The present study was designed to evaluate the safety of iliac vein stenting for May-Thurner syndrome (MTS) with subsequent pregnancy. METHODS:Female patients who had undergone common iliac vein stenting at our center who were aged 18 to 45 years and had subsequently become pregnant were identified. A retrospective medical record review of eight eligible patients was conducted, recording the demographics, procedural characteristics, and anticoagulation strategies. The primary outcome evaluated was stent patency. RESULTS:All eight patients had undergone left common iliac vein stenting for MTS. A total of eight stents were placed, and all demonstrated duplex ultrasound patency throughout pregnancy and postpartum. Seven patients delivered healthy pregnancies, and one experienced a stillbirth. The clinical CEAP (clinical, etiologic, anatomic, pathophysiologic) class remained unchanged or improved from pregnancy to postpartum for all patients. The average age at stent placement was 31 ± 5 years, and the average interval from stent placement to pregnancy was 28 ± 19 months. One patient developed nonobstructive deep vein thrombosis (DVT) of the left femoral vein during pregnancy and was treated with therapeutic enoxaparin. The nonobstructive DVT did not compromise the iliac vein stent. Two patients received low-dose aspirin and prophylactic doses of enoxaparin, one for a history of DVT and factor V Leiden and one for a recent history of fertility treatment. The five remaining patients received no anticoagulation, three received low-dose aspirin, and two received no antiplatelet therapy. CONCLUSIONS:Common iliac vein stent patency was not compromised by subsequent pregnancy in our eight patients with MTS. Furthermore, the stents remained patent throughout pregnancy in patients receiving a wide range of anticoagulation and antiplatelet treatments, suggesting that no uniform therapeutic threshold exists and treatment should be individualized. For most patients, low-dose aspirin alone or no treatment was adequate. This could have implications for counseling women who require intervention for MTS and are of child-bearing age.
PMID: 34438090
ISSN: 2213-3348
CID: 5011602

Initial US experience with the BlueLeaf Endovenous Valve Formation System [Meeting Abstract]

Marston, W; Muluk, S; Sadek, M; Gagne, P; Dexter, D
Objective: Chronic venous insufficiency (CVI), owing to deep vein reflux (DVR) and venous obstruction, is widespread and associated with significant morbidity. The BlueLeaf System has been designed to treat patients with symptomatic CVI with evidence of DVR. The BlueLeaf device is intended to form autogenous tissue leaflets from vein walls without the use of a permanent vascular implant. This report describes the early outcomes of the initial 6 patients treated in the United States.
Method(s): In 2 US centers, patients with DVR and CEAP classification of C5 or C6 were screened and treated using the BlueLeaf System. Retrograde percutaneous access was obtained through the common femoral vein, and contrast venography and intravascular ultrasound examination were used to identify at least two valve formation sites in the popliteal or femoral veins. The 16F study device was introduced and used to form up to two monocuspid valves. Post procedurally, patients were prescribed enoxaparin injections for 30 days, followed by 6 months of oral anticoagulation. Follow-up evaluations included duplex ultrasound examination, Venous Clinical Severity Score, and patient reported outcome surveys. Perioperative and postoperative adverse events were captured including the incidence of DVT, pulmonary embolism, and access site complications.
Result(s): Six patients were identified meeting the inclusion criteria with a mean age of 57.2 +/- 12.1 years, and a mean body mass index of 34.4 +/- 3.6. CEAP clinical class was C5 in two and C6 in four patients and four patients had a documented history of DVT. One or more monocuspid valves were successfully formed in 5/6 (83%) patients. In 1 patient with severe post-thrombotic changes the valve formation attempt was unsuccessful. Median follow-up time was 12 weeks. At 12 weeks, there was a mean decrease in reflux time (seconds) in the mid popliteal vein of -0.3 (-1.0 to 1.9) and a mean decrease in the peak reflux velocity (cm/sec) (PRV) of -3.0 (-1 to -50). Four of the five (80%) of patients that had reached the 12-week visit, experienced a decrease in Venous Clinical Severity Score with a mean improvement of -3.6 points. To date, there have been no DVT nor pulmonary embolism reported. One patient experienced intraprocedural ST segment depression. No access site related complications were reported. Nonocclusive valve cusp thrombus was reported in 1 patient, which resolved by 30 days.
Conclusion(s): In this initial US experience, endovenous valve formation was successful in the majority of cases. The limited data suggests meaningful improvement in symptoms with only a modest improvement in hemodynamic measures. The INFINITE-US study is ongoing and the enrollment of additional patients will help refine the BlueLeaf procedure as well as inform on the best hemodynamic measures.
Copyright
EMBASE:2016803008
ISSN: 2213-3348
CID: 5184032

Statin Use Reduces Mortality in Patients Who Develop Major Complications After Transcarotid Artery Revascularization [Meeting Abstract]

Chang, H; Zeeshan, M; Rockman, C B; Veith, F J; Laskowski, I; Kashyap, V S; Jacobowitz, G R; Garg, K; Sadek, M; Maldonado, T S
INTRODUCTION AND OBJECTIVES: The impact of preoperative statin use in patients undergoing transcarotid artery revascularization (TCAR) is not well established. The aim of this study was to evaluate the effect of statin on postoperative outcomes after TCAR.
METHOD(S): Vascular Quality Initiative registry (2012-2020) was queried for patients undergoing TCAR. Patient demographics, perioperative characteristics and 30-day outcomes were compared between patients treated with and without statins at least 30 days preoperatively. Multivariable logistic regression models were used to estimate the effect of statins on postoperative outcomes. RESULTS: A total of 15,797 patients underwent TCAR, and 10,116 (64%) were males. 14,152 (89.6%) patients were on statin preoperatively (Table). There was higher 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) in the statin group. Perioperative stroke and major adverse cardiac event (MACE; myocardial infarction, congestive heart failure and dysrhythmia) occurred in 1.5% and 2.4% among patients on statins and 1.4% and 2.3% among those not on statins, respectively. After adjusting for potential confounders and baseline differences, statin use was associated with 62% reduction in the odds of mortality (OR 0.38; 95% CI, 0.19-0.99; P=.047) in patients who developed a perioperative stroke or MACE after TCAR (Figure).
CONCLUSION(S): Statin use was associated with a significant reduction in postoperative mortality in patients who develop a stroke or MACE after TCAR. Therefore, strict adherence to statin is strongly recommended, particularly in patients who may be at high risk of major postoperative complications.[Formula presented]
Copyright
EMBASE:2016756291
ISSN: 1615-5947
CID: 5158152

Outcomes of transfemoral carotid artery stenting and transcarotid artery revascularization for restenosis after prior ipsilateral carotid endarterectomy

Chang, Heepeel; Rockman, Caron B; Veith, Frank J; Kashyap, Vikram S; Jacobowitz, Glenn R; Sadek, Mikel; Garg, Karan; Maldonado, Thomas S
OBJECTIVE:Restenosis after carotid endarterectomy (CEA) poses unique therapeutic challenges, with no specific guidelines available on the operative approach. Traditionally, transfemoral carotid artery stenting (TfCAS) has been regarded as the preferred approach to treating restenosis after CEA. Recently, transcarotid artery revascularization with a flow-reversal neuroprotection system (TCAR) has gained popularity as an effective alternative treatment modality for de novo carotid artery stenosis. The aim of the present study was to compare the contemporary perioperative outcomes of TfCAS and TCAR in patients with prior ipsilateral CEA. METHODS:The Vascular Quality Initiative database was reviewed for patients who had undergone TfCAS and TCAR for restenosis after prior ipsilateral CEA between January 2016 and August 2020. The primary outcome was the 30-day composite outcome of stroke and death. The secondary outcomes included 30-day stroke, transient ischemic attack (TIA), myocardial infarction (MI), death, and composite 30-day outcomes of stroke, death, and TIA, stroke and TIA, and stroke, death, and MI. Multivariable logistic regression models were used to evaluate the outcomes of interest after adjustment for potential confounders and baseline differences between cohorts. RESULTS:Of 3508 patients, 1834 and 1674 had undergone TfCAS and TCAR, respectively. The TCAR cohort was older (mean age, 71.6 years vs 70.2 years; P < .001) and less likely to be symptomatic (27% vs 46%; P < .001), with a greater proportion taking aspirin (92% vs 88%; P = .001), a P2Y12 inhibitor (89% vs 80%; P < .001), and a statin (91% vs 87%; P = .002) compared with the TfCAS cohort. Perioperatively, the TCAR cohort had had lower 30-day composite outcomes of stroke/death (1.6% vs 2.7%; P = .025), stroke/death/TIA (1.8% vs 3.3%; P = .004), and stroke/death/MI (2.1% vs 3.2%; P = .048), primarily driven by lower rates of stroke (1.3% vs 2.3%; P = .031) and TIA (0.2% vs 0.7%; P = .031). Among asymptomatic patients, the incidence of stroke (0.6% vs 1.4%; P = .042) and the composite of stroke/TIA (0.8% vs 1.8%; P = .036) was significantly lower after TCAR than TfCAS, and TCAR was associated with a lower incidence of TIA (0% vs 1%; P = .038) among symptomatic patients. On adjusted analysis, the TCAR cohort had lower odds of TIA (adjusted odds ratio, 0.17; 95% confidence interval, 0.04-0.74; P = .019). CONCLUSIONS:Among patients undergoing carotid revascularization for restenosis after prior ipsilateral CEA, TCAR was associated with decreased odds of 30-day TIA compared with TfCAS. However, the two treatment approaches were similarly safe in terms of the remaining perioperative outcomes, including stroke and death and stroke, death, and MI. Our results support the safety and efficacy of TCAR in this subset of patients deemed at high risk of reintervention.
PMID: 34506900
ISSN: 1097-6809
CID: 5067172

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

Review of the Current Evidence for Topical Treatment for Venous Leg Ulcers

Shaydakov, Maxim E; Ting, Windsor; Sadek, Mikel; Aziz, Faisal; Diaz, Jose A; Raffetto, Joseph D; Marston, William A; Lal, Brajesh K; Welch, Harold J
OBJECTIVE:The development of a venous leg ulcer (VLU) represents the most severe clinical manifestation of a chronic venous disease. Despite major progress, there is a limited understanding of VLU pathogenesis and wound healing biology. Treatment of VLUs remains a serious challenge for physicians of different specialties. This communication focuses on describing the rationale and scientific basis for topical wound care in the management of VLUs. METHODS:A literature review was performed to summarize methods with proven efficacy in VLU management. A systematic literature search was also performed to identify new evidence from the randomized controlled trials published within 2014-2021. The scientific challenges, clinical practice concerns, economic obstacles, and possible directions for further research have been discussed. RESULTS:Hundreds of topical products have been advertised for the treatment of VLUs. Published data on topical treatment of venous ulcers is insufficient, scattered, weak, and has significant methodological flaws. Forty-three randomized controlled trials on topical treatment of VLUs have been published within 2014-2021. Clinical practice guidelines need to be updated. Major gaps in knowledge have been identified, and suggestions for future research directions have been provided. CONCLUSIONS:The American Venous Forum Research Committee would like to bring attention to topical wound care for VLUs as a critical gap in knowledge, and encourage scientists, practitioners, and industry to collaborate to fill this gap.
PMID: 34171531
ISSN: 2213-3348
CID: 4925852

Natural History of Renal Artery Aneurysms [Meeting Abstract]

Harish, Keerthi; Zhang, Jason; Speranza, Giancarlo; Hartwell, Charlotte; Garg, Karan; Jacobowitz, Glenn; Sadek, Mikel; Maldonado, Thomas S.; Kim, Danny; Rockman, Caron
ISI:000798307600259
ISSN: 0741-5214
CID: 5244262

Abdominal aortic aneurysm neck dilatation and sac remodeling in fenestrated compared to standard endovascular aortic repair

Li, Chong; Teter, Katherine; Rockman, Caron; Garg, Karan; Cayne, Neal; Sadek, Mikel; Jacobowitz, Glenn; Silvestro, Michele; Ramkhelawon, Bhama; Maldonado, Thomas S
OBJECTIVE:Contemporary commercially available endovascular devices for the treatment of abdominal aortic aneurysm (AAA) include standard endovascular aortic repair (sEVAR) or fenestrated EVAR (fEVAR) endografts. However, aortic neck dilatation (AND) can occur in nearly 25% of patients following EVAR, resulting in loss of proximal seal with risk of aortic rupture. AND has not been well characterized in fEVAR, and direct comparisons studying AND between fEVAR and sEVAR have not been performed. This study aims to analyze AND in the infrarenal and suprarenal aortic segments, including seal zone, and quantify sac regression following fEVAR implantation compared to sEVAR. METHOD/METHODS:A retrospective review of prospectively collected data on 20 consecutive fEVAR patients (Cook Zenith® Fenestrated) and 20 sEVAR (Cook Zenith®) patients was performed. Demographic data, anatomic characteristics, procedural details, and clinical outcome were analyzed. Pre-operative, post-operative (1 month), and longest follow-up CT scan at an average of 29.3 months for fEVAR and 29.8 months for sEVAR were analyzed using a dedicated 3D workstation (iNtuition, TeraRecon Inc, Foster City, California). Abdominal aortic aneurysm neck diameter was measured in 5 mm increments, ranging from 20 mm above to 20 mm below the lowest renal artery. Sub-analysis comparing the fEVAR to the sEVAR group at 12 months and at greater than 30 months was performed. Standard statistical analysis was done. RESULTS:Demographic characteristics did not differ significantly between the two cohorts. The fEVAR group had a larger mean aortic diameter at the lowest renal artery, shorter infrarenal aortic neck length, increased prevalence of nonparallel neck shape, and longer AAA length. On follow-up imaging, the suprarenal aortic segment dilated significantly more at all locations in the fEVAR cohort, whereas the infrarenal aortic neck segment dilated significantly less compared to the sEVAR group. Compared to the sEVAR cohort, the fEVAR patients demonstrated significantly greater positive sac remodeling as evident by more sac diameter regression, and elongation of distance measured from the celiac axis to the most cephalad margin of the sac. Device migration, endoleak occurrence, re-intervention rate, and mortalities were similar in both groups. CONCLUSION/CONCLUSIONS:Compared to sEVAR, 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 post-operative period as compared to sEVAR. Moreover, the fEVAR cohort had significantly greater sac shrinkage and improved aortic remodeling. The suprarenal seal zone in fEVAR may result in a previously undescribed increased level of protection against infrarenal neck dilatation. We hypothesize that the resultant decreased endotension conferred by better seal zone may be responsible for a more dramatic sac shrinkage in fEVAR.
PMID: 34859694
ISSN: 1708-539x
CID: 5069252

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