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Superficial Venous Procedures can be Performed Safely and Effectively in Patients with Deep Venous Reflux

Li, Chong; Jacobowitz, Glenn R; Rockman, Caron B; Maldonado, Thomas S; Berland, Todd L; Garg, Karan; Barfield, Michael; Sadek, Mikel
INTRODUCTION/BACKGROUND:The finding of concurrent deep venous reflux (DVR) when interrogating superficial venous reflux is common and might be a marker for more severe chronic venous insufficiency. However, the safety, clinical and patient reported outcomes in patients undergoing superficial venous treatment in the presence of DVR remains underreported. Moreover, factors associated with persistence and disappearance of DVR after superficial vein treatments have not been evaluated. This study sought to address these questions. METHODS:This study was a review of the institutional vascular quality initiative (VQI) database from June 2016 to June 2021. Consecutive patient-limbs were identified who underwent a superficial venous intervention and had duplex evaluation. These patients were then divided into those with and without DVR. Those with DVR were further reviewed for anatomical details and persistence or resolution of DVR following the procedure. The primary outcome was the venous clinical severity score (VCSS) at follow-up greater than 3 months. Secondary outcomes included the incidence of any postoperative deep vein thrombosis (DVT) or endovenous heat-induced thrombosis (EHIT), differences in patient-reported outcomes, rate of resolution of DVR, and factors associated with DVR persistence. Both univariate analysis and multivariate logistic regression were applied. RESULTS:In patients who underwent superficial venous treatments 644 patient-limbs had DVR and 7812 did not, for a prevalence of 7.6%. The former group was associated with a higher burden of chronic venous insufficiency. On univariate analysis, patient-limbs, both with and without DVR, improved significantly in VCSS at less than 3 months follow-up, and were not significantly different. At greater than 3 months follow-up, the VCSS score again improved significantly compared to less than 3 months follow-up, but the two groups differed significantly at the longer interval. The magnitude of improvement in VCSS between the two groups at the longer follow-up were statistically similar (3.17±3.11 vs 3.03±2.93, P =0.739). HASTI score similarly improved significantly in both groups, but remained significantly higher in the DVR group on follow-up. On multivariate logistic regression, DVR was not associated with an increased VCSS at greater than 3 months follow-up. There was no intergroup difference in postoperative DVT or EHIT. 40.8% of limbs with DVR no longer had evidence of detectable DVR at the latest follow-up venous duplex, and DVR limited to single segment were more likely to be no longer detectable versus multi-segments. CONCLUSIONS:Superficial venous procedures are safe and effective in patients with DVR, leading to improvements in clinical and patient reported outcomes as they would for those without DVR. In a large proportion of the treated limbs, especially in those with DVR in a single segment, there is no longer evidence of DVR following superficial venous intervention. Although patients with DVR have a higher burden of chronic venous insufficiency, they appear to still derive significant benefit from superficial venous treatments.
PMID: 36368475
ISSN: 2213-3348
CID: 5357632

Periprocedural P2Y12 inhibitors improve perioperative outcomes after carotid stenting by primarily decreasing strokes

Heib, Adele; Chang, Heepeel; Rockman, Caron; Patel, Virendra; Jacobowitz, Glenn; Barfield, Michael; Siracuse, Jeffrey J; Faries, Peter; Lamparello, Patrick J; Cayne, Neal; Maldonado, Thomas; Garg, Karan
OBJECTIVE:inhibitors for CAS. METHODS:inhibitors as well as symptomatic status. Primary endpoints were perioperative neurologic events (strokes and transient ischemic attacks (TIAs)). Secondary endpoints were mortality and myocardial infarction. RESULTS:inhibitors used revealed that all appeared to be equally effective in reducing the periprocedural neurological event rate. CONCLUSIONS:inhibitors in the periprocedural period, leaving room for significant improvement.
PMID: 36328140
ISSN: 1097-6809
CID: 5358752

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

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

Mannitol Use is Renal Protective in Patients with Chronic Kidney Disease Requiring Suprarenal Aortic Clamping

Teter, Katherine; Rockman, Caron; Patel, Virendra; Chang, Heepeel; Jacobowitz, Glenn; Gelb, Bruce; Barfield, Michael; Cayne, Neal; Maldonado, Thomas; Garg, Karan
BACKGROUND:Mannitol is often administered during open juxtarenal or suprarenal aortic surgery to prevent ischemic injury to the kidneys. Prior evidence evaluating the benefits of intraoperative mannitol in reducing ischemia/reperfusion injury is conflicting and largely based on small, retrospective series. The aim of this study was to evaluate the effect of mannitol in preventing postoperative hemodialysis in patients undergoing open abdominal aortic aneurysm (AAA) repair where proximal control involved temporary renal ischemia. METHODS:The Society for Vascular Surgery Quality Initiative database was queried for all patients undergoing elective open AAA repair between 2003 and 2020. Patients were included in the current analysis if the proximal aortic clamp was placed above at least one renal artery. Chronic kidney disease (CKD) was defined as Cr > 1.8 mg/dL. Primary end points were 30-day major morbidity (myocardial infarction, respiratory complications, lower extremity or intestinal ischemia, and the need for temporary or permanent hemodialysis) and mortality. Comparisons were made between the mannitol and nonmannitol cohorts and stratified by the presence of preexisting CKD. RESULTS:During the study period, 4,156 patients underwent elective open AAA repair requiring clamp placement more than one (32.7%) or both (67.3%) renal arteries; 182 patients (4.4%) had preexisting CKD. Overall, 69.8% of patients received mannitol during their surgery. Mannitol was more frequently used in cases involving clamp placement above both renal arteries (70.3%) than one renal artery (61.5%). While prolonged ischemia time (more than 40 min) was associated with a higher risk of postoperative dialysis in patients without CKD, it was not significant in patients with baseline CKD. On a univariate analysis, mannitol use in patients with CKD was associated with a lower risk of postoperative dialysis (P = 0.005). This remained significant on a multivariate analysis (P = 0.008). Mannitol use did not appear to confer renal protective effects in patients without baseline CKD. CONCLUSIONS:Mannitol use was associated with a decreased risk of need for postoperative hemodialysis in patients with CKD undergoing suprarenal aortic clamping for open aneurysm repair. In appropriately selected patients, particularly those with underlying renal insufficiency, mannitol may confer a renal protective effect in open repair of pararenal AAA requiring suprarenal clamping.
PMID: 35452789
ISSN: 1615-5947
CID: 5218642

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

Anticoagulation Therapy is Associated with Increased Access-related Wound Infections after Hemodialysis Access Creation

Kumpfbeck, Andrew; Rockman, Caron B; Jacobowitz, Glenn R; Lugo, Joanelle Z; Barfield, Michael E; Scher, Larry A; Nigalaye, Anjali A; Garg, Karan
BACKGROUND:The effect of anticoagulation therapy (AC) on hemodialysis access patency and related complications is not well defined. Patients on long-term or chronic AC due to their underlying comorbid conditions may be particularly susceptible to access-related bleeding and complications from repetitive cannulation. Our goal is to assess the effect of anticoagulation therapy on outcomes after access creation. METHODS:The Vascular Quality Initiative (VQI) database was queried for patients undergoing arteriovenous fistula (AVF) or graft (AVG) placement, from 2011 to 2019. Only patients with data on post-procedural AC status were included. Anticoagulation use was defined as patients on warfarin, dabigatran, or rivaroxaban after access creation at postoperative follow up. Demographic and procedural details were analyzed. Wound infection and patency rates at six months were assessed. Binomial logistic regression analysis was performed to assess the association of anticoagulation use with these outcomes. RESULTS:A total of 27,757 patients underwent access creation, with the majority undergoing AVF creation (78.8%). The average age was 61.4 years and 55.3% were male. 12.9% of patients were on postoperative AC. The wound infection rate was 2.3- 3.8% in the no AC and AC cohorts, respectively (P < 0.001). At six months follow-up, patency was 85.7- 84.3% in the no AC and AC cohorts, respectively (P = 0.044). Expectedly, grafts had lower patency rates compared to AVF; those within the no AC cohort had a patency of 83.0% compared to 81.2 % in those on AC (P = 0.106). On multivariable analysis, anticoagulation use was associated with a higher risk of wound infections (odds ratio [OR] 1.513, 95% confidence interval [CI] 1.160-1.973, P = 0.002). AC use did not significantly affect access patency. CONCLUSION/CONCLUSIONS:Anticoagulation therapy was associated with a higher rate of wound infections but did not affect short-term access patency within six-months. These patients warrant close surveillance of their access for signs of infection. Furthermore, long-term implications of anticoagulation needs further evaluation.
PMID: 34687891
ISSN: 1615-5947
CID: 5068222

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

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

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