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Outcomes Of Translumbar Embolization Of Type II Endoleaks Following Endovascular Abdominal Aortic Aneurysm Repair

Charitable, John F; Patalano, Peter I; Garg, Karan; Maldonado, Thomas S; Jacobowitz, Glenn R; Rockman, Caron B; Veith, Frank J; Cayne, Neal S
OBJECTIVES/OBJECTIVE:Presence of an endoleak can compromise aneurysm exclusion after endovascular abdominal aortic aneurysm repair(EVAR). Type II endoleaks(T2Es) are most common and may cause sac expansion. We report outcomes of translumbar embolization(TLE) of T2Es following EVAR. METHODS:We conducted a retrospective chart review of patients with T2E after EVAR treated with TLE from 2011-2018 at a single academic institution. Treatment indications were the presence of persistent T2E and aneurysm growth ≥5mm. Sac stabilization was defined as growth ≤5mm throughout the follow-up period. RESULTS:Thirty consecutive patients were identified. The majority were men (n=24) with a mean age of 74.3 years (70.9-77.6, 95% CI). The most common comorbidities were hypertension (83.3%) and coronary artery disease (54.0%). The mean maximal sac diameter at T2E discovery was 5.8 cm (5.4-6.2, 95% CI). The mean time to intervention from endoleak discovery was 33.7±28 months with a mean growth of 0.84 cm (0.48-1.2, 95% CI) during that time period. The mean follow-up time after TLE was 19.1 months (11.1-27.2, 95% CI). Twenty-eight patients were treated with cyanoacrylate glue(CyG) alone, and 2 were treated with CyG plus coil embolization(CE). There was immediate complete endoleak resolution as assessed intraoperatively, and sac stabilization in 15 cases (50.0%). Eleven (36.7%) patients had evidence of persistent T2E on initial imaging after the embolization procedure; additional follow-up revealed eventual sac stabilization at a mean of 21.3±7.2 months and therefore these patients did not require further intervention. In the remaining four cases (13.3%) there was persistent T2E after the initial TLE requiring a second intervention. Repeat TLE stabilized growth in three of these four patients after a mean of 17.6±12.9 months. One patient required open sacotomy and ligation of lumbar vessels due to continued persistence of the T2E and continued aneurysm growth. There were no ischemic complications related to the embolization procedures. Factors associated with persistent endoleak after initial embolization were: larger aneurysm diameter at the time of initial endoleak identification (p<0.001), and the use of antiplatelet agents (p<0.02). The use of anticoagulation was not a significant risk factor for endoleak recurrence or aneurysm growth after TLE. CONCLUSIONS:TLE of T2E is a safe and effective treatment option for T2E with aneurysm growth following EVAR. Patients taking antiplatelet medication and those with larger aneurysms at the time of endoleak identification appear to be at increased risk for persistent endoleak and need for subsequent procedures following initial TLE. These patients may require more intensive monitoring and follow-up.
PMID: 34197948
ISSN: 1097-6809
CID: 4926902

Prior Infrarenal Aortic Surgery is Not Associated with Increased Risk of Spinal Cord Ischemia Following Thoracic Endovascular Aortic Repair and Complex Endovascular Aortic Repair

Chen, Stacey; Rokosh, Rae S; Smith, Deane E; Maldonado, Thomas S; Cayne, Neal S; Jacobowitz, Glenn R; Rockman, Caron B; Patel, Virendra I; Veith, Frank J; Galloway, Aubrey C; Garg, Karan
OBJECTIVES/OBJECTIVE:Patients with prior infrarenal aortic intervention represent an increasing demographic of patients undergoing thoracic endovascular aortic repair (TEVAR) and/or complex EVAR. Studies have suggested that prior abdominal aortic surgery is a risk factor for spinal cord ischemia (SCI). However, these results are largely based on single-center experiences with limited multi-institutional and national data assessing clinical outcomes in these patients. The objective of this study was to evaluate the effect of prior infrarenal aortic surgery on SCI. METHODS:The Society for Vascular Surgery Vascular Quality Initiative database was retrospectively reviewed to identify all patients ≥18 years old undergoing TEVAR/complex EVAR from January 2012 to June 2020. Patients with previous thoracic or suprarenal aortic repairs were excluded. Baseline and procedural characteristics and postoperative outcomes were compared by group: TEVAR/complex EVAR with or without previous infrarenal aortic repair. The primary outcome was postoperative SCI. Secondary outcomes included postoperative hospital length of stay (LOS), bowel ischemia, renal ischemia, and 30-day mortality. Multivariate regression was used to determine independent predictors of postoperative SCI. Additional analysis was performed for patients undergoing isolated TEVAR. RESULTS:A total of 9506 patients met the inclusion criteria: 8691 (91.4%) had no history of infrarenal aortic repair and 815 (8.6%) had previous infrarenal aortic repair. Patients with previous infrarenal repair were older with an increased prevalence of chronic kidney disease (p=0.001) and cardiovascular risk factors including hypertension, chronic obstructive pulmonary disease, and smoking history (p<0.001). These patients presented with larger maximal aortic diameters (6.06±1.47 cm versus 5.15±1.76 cm; p<0.001) and required more stent grafts (p<0.001) with increased intraoperative blood transfusion requirements (p<0.001), and longer procedure times (p<0.001). Univariate analysis demonstrated no difference in postoperative SCI, postoperative hospital LOS, bowel ischemia, or renal ischemia between the two groups. Thirty-day mortality was significantly higher in patients with prior infrarenal repair (p=0.001). On multivariate regression, prior infrarenal aortic repair was not a predictor of postoperative SCI, while aortic dissection (odds ratio [OR] 1.65; 95% confidence interval [CI] 1.26-2.16, p<0.001), number of stent grafts deployed (OR 1.45; 95% CI 1.30-1.62, p<0.001), and units of packed red blood cells transfused intraoperatively (OR 1.33; 95% CI 1.03-1.73, p=0.032) were independent predictors of SCI. CONCLUSIONS:Although TEVAR/complex EVAR patients with prior infrarenal aortic repair constituted a sicker cohort with higher 30-day mortality, the rate of SCI was comparable to patients without prior repair. Previous infrarenal repair was not associated with risk of SCI.
PMID: 34742886
ISSN: 1097-6809
CID: 5050112

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

Risk Factors For and Intra-operative Management of Intolerance to Flow Reversal in TCAR

Teter, Katherine; Rockman, Caron; Lamparello, Patrick; Macdonald, Sumaira; Garg, Karan; Barfield, Michael; Maldonado, Thomas S
OBJECTIVES/OBJECTIVE:In patients deemed high risk for carotid endarterectomy (CEA) who are indicated for treatment of carotid artery stenosis (CAS), transcarotid artery revascularization (TCAR) has been demonstrated as a safe and effective alternative to trans-femoral carotid artery stenting (TF-CAS). Compared to CEA, where approx. 12% of patients undergoing awake intervention do not tolerate internal carotid artery (ICA) clamping, only 1-2% of patients were observed to have intolerance to flow reversal during TCAR based on data from the ROADSTER1/2 trials. This study reviewed awake interventions from those trials to assess factors associated with intolerance to flow reversal and review how those cases were managed. METHODS:This is a retrospective review of prospectively collected data from Reverse Flow Used During Carotid Artery Stenting Procedure (ROADSTER) multicenter trial along with the subsequent post-approval (ROADSTER-2) trial. The subset of patients from both trials undergoing awake TCAR was analyzed to compare demographics, procedural details, and anatomic factors between patients who did and did not experience intolerance to reversal of flow to assess for predisposing factors. Patients were deemed intolerant to flow reversal at the discretion of the operator, often related to changes in completion of neurologic tasks, hemodynamic stability, or patient reported symptoms. RESULTS:103 patients from ROADSTER and 194 patients from ROADSTER-2 underwent TCAR under local/regional anesthesia. Of these, 8 patients had intolerance to flow reversal, though all cases were successfully completed. While intra-operative hemodynamic data was only available for 5 of the 8 intolerant patients, none experienced hypotension. 4 cases were completed under low flow reversal, 3 cases were successfully weaned from low to high flow over several minutes, and 1 case required general anesthesia. No significant association was found between intolerance to flow reversal and comorbidities including diabetes mellitus (DM), hypertension (HTN), hyperlipidemia (HLD), congestive heart failure (CHF), prior MI or angina, pre-op CAS-related symptoms, prior stroke, prior CAS or CEA, prior neck radiation, tandem stenosis, high cervical stenosis, or hostile neck (tables 1, 2). A trend towards significance was seen with chronic obstructive pulmonary disease (COPD) and contralateral carotid artery occlusion (p= 0.086 and 0.139, respectively). CONCLUSIONS:Despite intolerance to flow reversal, TCAR cases were successfully completed by adjusting reversal-of-flow rate and do not typically require conversion to GETA. While factors contributing to intolerance of flow reversal during TCAR remain poorly understood, this study identified a trend towards significance with an association of pre-existing COPD and contralateral carotid artery occlusion. Given the low number of patients who experienced this issue, a larger sample size is required to better elucidate these trends.
PMID: 34688872
ISSN: 1615-5947
CID: 5042142

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

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

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

The Presence of a Pathologic Perforator May be Predictive of Central Venous Pathology and Multilevel Disease in Severe Chronic Venous Insufficiency

Li, Chong; Nwachukwu, Chukwuma; Jacobowitz, Glenn R; Kabnick, Lowell S; Maldonado, Thomas S; Rockman, Caron B; Berland, Todd L; Sadek, Mikel
INTRODUCTION/BACKGROUND:The treatment of a refluxing perforator is indicated in the setting of severe chronic venous insufficiency, but there are limited data on the presence of multilevel disease in these patients. This study sought to evaluate whether the presence of a pathologic perforator is predictive of the presence of central venous pathology. METHODS:This study was a retrospective review of the institutional vascular quality initiative (VQI) database. Consecutive patient-limbs were identified who underwent intervention of refluxing perforators. The patients who underwent imaging, including MRI or CT (Group A) were compared to those who did not undergo imaging (Group B). The treated limbs in Group A were also compared to the contralateral limbs as an internal control. Anatomical findings on imaging were analyzed by two independent investigators. The primary outcome was the presence and degree of central venous stenosis as measured by an orthogonal diameter reduction of > 50% by axial imaging. Secondary outcomes included demographic and clinical differences between the two groups, frequency of central venous intervention, and duration of ulcer healing. Standard statistical analysis was performed. RESULTS:Ninety-three patient-limbs underwent treatment of a pathologic perforator, with 30 in Group A and 63 in Group B. The following demographic and clinical variables were higher in Group A compared to Group B: Male gender, BMI, deep venous thrombosis history, recent or active anticoagulation use, perforator diameter, Clinical Etiology Anatomy Pathophysiology class 4, 5 or 6, and Venous Clinical Severity Score. Radiographic analysis of Group A revealed concordance of a treated pathological perforator with an ipsilateral central venous stenosis in 53.3% of patients, and a higher frequency of common iliac vein stenosis (50% vs 21.4%, P = 0.024) and external iliac vein stenosis (20% vs 0%, P = 0.012) compared to the contralateral limbs. When separated by left or right limb, the left limbs exhibited a greater degree of common iliac vein stenosis as compared to the contralateral limbs (50.7±20.9% vs 16.3±16.5%, P < 0.001) as well as a greater frequency of >50% common iliac vein stenosis (46.7% vs 13.3%, P = 0.046). The right limbs exhibited a greater frequency of > 50% external iliac vein stenosis as compared to contralateral limbs (33.3% vs 0%, P = 0.022). CONCLUSIONS:This study suggests that patients with severe chronic venous insufficiency who undergo treatment for a pathologic perforator may have additional ipsilateral central venous pathology, supporting the presence of multilevel disease. Additional axial imaging might unmask central venous pathology and provide another option for treatment.
PMID: 34252577
ISSN: 2213-3348
CID: 4938302

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