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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

To screen or not to screen…

Rockman, Caron
PMID: 36549799
ISSN: 1097-6809
CID: 5394742

Beta-blocker Use After Thoracic Endovascular Aortic Repair in Patients with Type B Aortic Dissection Is Associated with Improved Early Aortic Remodeling

Chang, Heepeel; Rockman, Caron B; Ramkhelawon, Bhama; Maldonado, Thomas S; Cayne, Neal S; Veith, Frank J; Jacobowitz, Glenn R; Patel, Virendra I; Laskowski, Igor; Garg, Karan
OBJECTIVE:Beta-blockers are first-line anti-impulse therapy in patients presenting with acute type B aortic dissection (TBAD). However, little is understood about their impact after aortic repair. The aim of this study was to evaluate the role of postoperative beta-blocker use on outcomes of thoracic endovascular aortic repair (TEVAR) in TBAD. METHODS:The Vascular Quality Initiative database was queried for all patients undergoing TEVAR for TBAD from 2012 to 2020. Aortic-related reintervention, all-cause mortality and effect of TEVAR on false lumen thrombosis of the treated aortic segment were assessed and compared between patients treated with and without beta-blocker postoperatively. Cox proportional hazards models were used to estimate the effect of beta-blocker therapies on outcomes. RESULTS:1,114 patients undergoing TEVAR for TBAD were identified with a mean follow-up of 18±12 months. The mean age was 61.1±11.9 years, and 791 (71%) were male. 935 (84%) patients were maintained on beta-blocker at discharge and follow-up. Patients on beta-blocker were more likely to have an entry tear originating in zones 1-2 (22% vs 13%; P=.022). The prevalence of acute, elective and symptomatic AD, concurrent aneurysm, number of endografts used, distribution of the proximal and distal zones of dissection and operative time were comparable between the two cohorts. At 18-months, significantly more complete false lumen thrombosis (58 vs 47%; log-rank P=.018) was observed in patients on beta-blocker while the rates of aortic-related reinterventions (13% vs 9%; log-rank P=.396) and mortality (0.2% vs 0.7%; log-rank P=.401) were similar in patients with and without beta-blocker, respectively. Even after adjusting for clinical and anatomic factors, postoperative beta-blocker use was associated with increased complete false lumen thrombosis (HR 1.56; 95% CI: 1.10-2.21; P=.012) but did not affect mortality or aortic-related reintervention. A secondary analysis of beta-blocker use in acute versus chronic TBAD showed a higher rate of complete false lumen thrombosis in patients on beta-blocker in chronic TBAD (59% vs 38%; log-rank P=.038). In contrast, there was no difference in the rate of complete false lumen thrombosis in acute TBAD between the two cohorts (58% vs 51%; log-rank P=.158). When analyzed separately, postoperative ACE inhibitor use did not affect the rates of complete false lumen thrombosis, mortality and aortic-related reintervention. CONCLUSIONS:Beta-blocker use was associated with promotion of complete false lumen in patients undergoing TEVAR for TBAD. In addition to its role in acute setting, anti-impulse control with beta-blocker appears to confer favorable aortic remodeling and may improve outcomes after TEVAR, particularly for chronic TBAD.
PMID: 35868420
ISSN: 1097-6809
CID: 5279412

Déjà vu: Plaque morphology revisited

Rockman, Caron
PMID: 36410846
ISSN: 1097-6809
CID: 5372022

Multi-institutional patterns of clopidogrel response among patients undergoing transcarotid artery revascularization

Rokosh, Rae S; Rockman, Caron; Garg, Karan; Wang, Shihuan Keisin; Motaganahalli, Raghu L; Schroeder, Andrew C; Sobraske, Peter J; Stoner, Michael C; Tarbunou, Yauhen A; Marmor, Rebecca A; Malas, Mahmoud B; Maldonado, Thomas S
OBJECTIVE:Current guidelines recommend dual antiplatelet therapy (DAPT) in patients undergoing carotid artery stenting. The most common DAPT regimen is aspirin and clopidogrel, a P2Y12 receptor antagonist; however, the prevalence of clopidogrel resistance (CR) in patients undergoing percutaneous coronary interventions may exceed 60%. Few studies have investigated the prevalence and impact of CR in patients undergoing extracranial carotid artery stenting, particularly transcarotid artery revascularization (TCAR). METHODS:Consecutive high-risk patients ≥ 18 years who underwent TCAR for high grade (≥70%) and/or symptomatic (≥50%) carotid stenosis with preoperative P2Y12 testing between August 2019 and December 2021 were identified across five institutions. Preoperative platelet reactivity was measured with the VerifyNow P2Y12 Reaction Unit (PRU) Test (Instrumentation Laboratory, Bedford, MA), with CR defined as PRU ≥ 194 and hyper-response as PRU <70. Patients without preoperative P2Y12 testing within 30 days prior to TCAR or those on a non-clopidogrel P2Y12 inhibitor preoperatively were excluded. The primary outcome of interest was prevalence of CR. Secondary outcomes of interest included the incidence of ischemic and hemorrhagic complications. RESULTS:= 1) between clopidogrel phenotypes. Three (3.3%) patients, one CR (PRU 240) and two responders (PRU 119 and PRU 189), experienced postoperative access site hematomas that required no subsequent intervention. No other index hospitalization hemorrhagic complications occurred. CONCLUSIONS:Using preoperative P2Y12 testing with a threshold PRU ≥ 194 to define CR, we identified a high prevalence of CR in patients undergoing TCAR similar to that in the pre-existing coronary literature. We found no significant differences in postoperative ischemic or hemorrhagic complications by clopidogrel response phenotype, although complication rates in the overall study cohort were low. CR may be a spectrum from responder to partial responder to complete non-responder, and this may account for the differences in our CR cohort compared to the ROADSTER 2 protocol deviation cohort. Further investigation is warranted to determine if a quantitative assessment of CR is sufficient to identify patients at risk of developing secondary cerebrovascular ischemic events in this patient population.
PMID: 36428145
ISSN: 1708-539x
CID: 5384482

Natural history of renal artery aneurysms

Zhang, Jason; Harish, Keerthi; Speranza, Giancarlo; Hartwell, Charlotte A; Garg, Karan; Jacobowitz, Glenn R; Sadek, Mikel; Maldonado, Thomas; Kim, Danny; Rockman, Caron B
OBJECTIVE:The existing renal artery aneurysm (RAA) literature is largely composed of reports of patients who underwent intervention. The objective of this study was to review the natural history of RAA. METHODS:This single-institution retrospective analysis studied all patients with RAA diagnosed by computed tomography imaging between 2015 and 2019, identified by our institutional radiology database. Imaging, demographic, and clinical data were obtained via the electronic medical record. He growth rate was calculated for all patients with radiological follow-up. RESULTS:The cohort consists of 331 patients with 338 RAAs. Most patients were female (61.3%), with 11 (3.3%) of childbearing age. The mean age at diagnosis was 71.5 years (range, 24-99 years). Medical comorbidities included hypertension (73.7%), prior smoking (34.4%), and connective tissue disease (3.9%). Imaging indications included abdominal pain (33.5%), unrelated follow-up (29.6%), and follow-up of an RAA initially diagnosed before the study period (10.7%). Right RAA (61.9%) was more common than left (35.1%); 3% of patients had bilateral RAA. The mean diameter at diagnosis was 12.9 ± 5.9 mm. Size distribution included lesions measuring less than <15 mm (69.9%), 15 to 25 mm (27.1%), and more than 25 mm (3.0%). Anatomic locations included the distal RA (26.7%), renal hilum (42.4%), and mid-RA (13.1%). The majority were true aneurysms (98%); of these, 72.3% were fusiform and 27.7% were saccular. Additional characteristics included calcification (82.2%), thrombus (15.9%), and dissection (0.9%). Associated findings included aortic atherosclerosis (65.6%), additional visceral aneurysms (7.3%), and abdominal aortic aneurysm (5.7%). The mean clinical follow-up among 281 patients was 41.0 ± 24.0 months. The mean radiological follow-up among 137 patients was 26.0 ± 21.4 months. Of these, 43 patients (31.4%) experienced growth, with mean growth rate of 0.23 ± 4.7 mm/year; the remainder remained stable in size. Eight patients eventually underwent intervention (5 endovascular), with the most common indications including size criteria (4/8) and symptom development (3/8). No patient developed rupture. On multivariate analysis, obesity (P = .04) was significantly associated with growth. An initial diameter of more than 25 mm was significantly associated with subsequent intervention (P = .006), but was not significantly associated with growth. Four of five RAAs with an initial diameter 30 mm or greater did not undergo intervention. The mean clinical follow-up for these patients was 24 months; none developed rupture and two remained stable in size. CONCLUSIONS:This large institutional cohort found that the majority of RAAs remained stable in size, with few patients meeting indications for repair based on societal guidelines. Current guidelines recommending intervention for asymptomatic aneurysms more than 30 mm seem to be appropriate given their slow progression.
PMID: 36375725
ISSN: 1097-6809
CID: 5384752

The Impact of Aorto-uni-iliac Graft Configuration on Outcomes of Endovascular Repair for Ruptured Abdominal Aortic Aneurysms

Rokosh, Rae S; Chang, Heepeel; Lui, Aiden; Rockman, Caron B; Patel, Virendra I; Johnson, William; Siracuse, Jeffrey; Cayne, Neal S; Jacobowitz, Glenn R; Garg, Karan
INTRODUCTION/BACKGROUND:Endovascular aneurysm repair (EVAR) has improved outcomes for ruptured abdominal aortic aneurysms (rAAA) compared to open repair. We examined the impact of aorto-uni-iliac (AUI) versus standard bifurcated endograft configuration on outcomes in rAAA. METHODS:Patients 18 years or older in the VQI database who underwent EVAR for rAAA from January 2011 to April 2020 were included. Patient characteristics were analyzed by graft configuration: AUI or standard bifurcated. Primary and secondary outcomes included 30-day mortality, post-operative major adverse events (MAE; myocardial infarction, stroke, heart failure, mesenteric ischemia, lower extremity embolization, dialysis requirement, re-operation, pneumonia or re-intubation) and 1-year mortality. A subset propensity-score matched (PSM) cohort was also analyzed. RESULTS:We included 2717 patients: 151 had AUI and 2566 had standard bifurcated repair. There was no significant difference between groups in terms of age, major medical comorbidities, anatomic aortic neck characteristics, or rates of conversion to open repair. Patients undergoing AUI were more commonly female (30% vs. 22%, p=0.011) and had a history of CHF (19% vs. 12%, p=0.013). Perioperatively, patients undergoing AUI had a significantly higher incidence of cardiac arrest (15% vs. 7%, p<0.001), greater intra-operative blood loss (1.3L vs. 0.6L, p<0.001), longer operative duration (218min vs. 138min, p<0.0001), higher incidence of MAE (46.3% vs. 33.3%, p=0.001), as well as prolonged ICU (7 vs. 4.7 days p=0.0006) and overall hospital length of stay (11.4 vs. 8.1 days, p=0.0003). Kaplan-Meier survival analyses demonstrated significant differences in 30-day (31.1% vs. 20.2%, log-rank p=0.001) and 1-year mortality (41.7% vs. 27.7%, log-rank p=0.001). The PSM cohort demonstrated similar results. CONCLUSION/CONCLUSIONS:The AUI configuration for rAAA appears to be implemented in a sicker cohort of patients and is associated with worse perioperative and 1-year outcomes compared to a bifurcated graft configuration, which was also seen on propensity matched analysis. Standard bifurcated graft configuration may be the preferred approach in the management of rAAA unless AUI configuration is mandated by patient anatomy or other extenuating circumstances.
PMID: 36368646
ISSN: 1097-6809
CID: 5357652

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

Safety And Efficacy of Drug Eluting Stents for Treatment of Transplant Renal Artery Stenosis

Chang, Heepeel; Gelb, Bruce E; Stewart, Zoe A; Lonze, Bonnie E; Garg, Karan; Rockman, Caron B; Jacobowitz, Glenn R; Maldonado, Thomas S; Berger, Jonathan C; Ali, Nicole M; Cayne, Neal S
OBJECTIVE:Transplant renal artery stenosis (TRAS) after renal transplantation is a common cause of graft dysfunction and failure. Endovascular intervention in the form of percutaneous transluminal angioplasty (PTA) and stenting has rapidly become the dominant treatment modality for the TRAS. There is a paucity of clinical data on use of drug-eluting stent (DES) for TRAS. We investigated the outcomes of patients with clinically significant TRAS undergoing DES placement. METHODS:A retrospective review of patients with clinically significant TRAS undergoing PTA with DES placement from June 2014 to April 2021 was conducted. Patients treated for TRAS exhibited uncontrolled hypertension and/or unexplained allograft dysfunction. Patient demographics, procedural details, and follow-up outcomes were collected. Primary endpoints were the in-stent primary patency and graft survival. Secondary endpoints were freedom from reintervention, primary-assisted patency and access-related complications. RESULTS:Thirteen TRAS in twelve patients with graft function alteration were treated with DES. The median age was 57 years (interquartile range (IQR), 48-63 years), and nine (70%) patients were male (Table). The median follow-up was 9 months (IQR, 4-52 months). The most common comorbidity was hypertension (100%), coronary artery disease (83%) and diabetes. The median time from deceased donor transplant to intervention was 5.8 months (IQR, 3.5-6.7 months). TRAS was most commonly found at the juxta-ostial segment (77%). The procedure was performed with carbon dioxide angiography with minimal amount of iodinated contrast (median, 3 mL) under local anesthesia in nine (69%) and general anesthesia in four (31%) patients. The median stent diameter was 4.5 mm (IQR, 4-5 mm), and the median stent length was 15 mm (IQR, 15-18 mm). No intraoperative complications occurred. The rates of stenosis-free primary patency of the DES and graft survival were 76% and 100%, respectively. All three reinterventions for restenosis resulted from the kinking of the transplant renal artery proximal to the DES, which were treated by extending the stent more proximally 1-2 mm into the external iliac artery. There were no access-related complications. The median time to reintervention was 0.9 months (range, 0.23-2 months). Freedom from reintervention and primary-assisted patency were 76% and 100%, respectively. CONCLUSIONS:Our study demonstrates that DES is a safe and effective treatment modality in patients with TRAS at short to mid-term follow-up. As all reinterventions after DES were performed due to kinking of the transplant renal artery proximal to the stent, bridging of the DES 1-2 mm into the external iliac artery is recommended.
PMID: 35413413
ISSN: 1615-5947
CID: 5204372

Hypogastric Artery Flow Interruption is Associated with Increased Mortality After Open Aortic Repair

Zhang, Jason; Chang, Heepeel; Rockman, Caron; Patel, Virendra I; Veeraswamy, Ravi; Berland, Todd; Ramkhelawon, Bhama; Maldonado, Thomas; Cayne, Neal; Jacobowitz, Glenn; Garg, Karan
BACKGROUND:Potential complications of pelvic flow disruption during aortic aneurysm repair include buttock ischemia and mesenteric ischemia. Unilateral or bilateral hypogastric artery flow interruption, either from atherosclerosis or intentionally to facilitate aneurysm repair, is considered problematic in endovascular repair; however, it has not been well studied in open abdominal aortic aneurysm (AAA) repair (OAR). We sought to examine the effect of interruption of flow to one or both hypogastric arteries on outcomes after OAR. METHODS:The Society for Vascular Surgery Quality Initiative database was queried for all patients undergoing elective open AAA repair between 2003 and 2020. (redundant) Patients with appropriate data on their hypogastric arteries postoperatively were stratified into two groups-patent bilaterally (normal pelvic perfusion, NPP) and unilateral or bilateral occlusion or ligation (compromised pelvic perfusion, CPP). Primary endpoints were 30-day major morbidity (myocardial infarction, respiratory complications, renal injury, and lower extremity or intestinal ischemia) and mortality. RESULTS:During the study period, 9.492 patients underwent elective open AAA repair-860 (9.1%) with compromised pelvic perfusion and 8,632 (90.9%) with patent bilateral hypogastric arteries. The groups had similar cardiac risk factors, including a history of coronary artery disease, prior coronary intervention, and the use of P2Y12 inhibitors and statins. A majority of patients in the CPP cohort had concurrent iliac aneurysms (63.3% vs. 24.8%; P < 0.001). The perioperative mortality was significantly higher in patients with compromised pelvic perfusion (5.5% vs. 3.1%; P < 0.001). Bilateral flow interruption had a trend toward higher perioperative mortality compared to unilateral interruption (7.1% vs. 4.7%; P < 0.147). The CPP group also had increased rates of myocardial injury (6.7% vs. 4.7%; P = 0.012), renal complications (18.9% vs. 15.9%; P = 0.024), leg and bowel ischemia (3.5% vs. 2.1%; P = 0.008; and 5.7% vs. 3.4%; P < 0.001, respectively). On multivariable analysis, CPP was associated with increased perioperative mortality (OR 1.47, CI 1.14-1.88, P = 0.003). On Kaplan-Meier analysis, there was no difference in survival at 2 years postdischarge between the NPP and CPP cohorts (86.1% vs. 87.5%, log-rank P = 0.275). CONCLUSIONS:Compromised pelvic perfusion is associated with increased perioperative complications and higher mortality in patients undergoing OAR. The sequelae of losing pelvic perfusion, in addition to the presence of more complex atherosclerotic and aneurysmal disease resulting in more difficult dissection, likely contribute to these findings. Thus, patients considered for OAR who have occluded hypogastric arteries or aneurysmal involvement of the hypogastric artery preoperatively may be candidates for more conservative management beyond traditional size criteria.
PMID: 35654287
ISSN: 1615-5947
CID: 5236152