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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

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

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

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

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

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

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

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

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

Access site complications are uncommon with vascular closure devices or manual compression after lower extremity revascularization

Cheng, Thomas W; Farber, Alik; King, Elizabeth G; Levin, Scott R; Arinze, Nkiruka; Malas, Mahmoud B; Eslami, Mohammad H; Garg, Karan; Rybin, Denis; Siracuse, Jeffrey J
OBJECTIVE:Vascular closure devices (VCDs) and manual compression (MC) are used to achieve hemostasis after peripheral vascular interventions (PVIs). We sought to compare perioperative outcomes between MC and four VCDs after PVI in a multicenter setting. METHODS:The Vascular Quality Initiative was queried for all lower extremity PVIs with common femoral artery access performed from 2010 to 2020. The VCDs included were MynxGrip (Cordis, Santa Clara, CA), StarClose SE (Abbott Vascular, Redwood City, CA), Angio-Seal (Terumo, Somerset, NJ), and Perclose ProGlide (Abbott Vascular). In a blinded fashion, these four VCDs (labeled A, B, C, and D) were compared to MC for baseline characteristics, procedural details, and outcomes (access site hematoma and stenosis/occlusion). Those with a sheath size >8F were excluded. Propensity score matching (1:1) was performed. Univariable and multivariable analyses were completed for unmatched and matched data. RESULTS:A total of 84,172 lower extremity PVIs were identified. Of these, 32,013 (38%) had used MC and 52,159 (62%) had used VCDs (A, 12,675; B, 6224; C, 19,872; D, 13,388). The average age was 68.7 years, and 60.4% of the patients were men. The most common indications for intervention were claudication (43.8%) and tissue loss (40.1%). Compared with MC, VCDs were used more often for patients with obesity, diabetes, and end-stage renal disease (P < .001 for all). VCDs were used less often for patients with hypertension, chronic obstructive pulmonary disease, coronary artery disease, prior percutaneous coronary and extremity interventions, and major amputation (P < .001 for all). VCD use was more common than MC during femoropopliteal (73% vs 63.8%) and tibial (33.8% vs 22.3%) interventions but less common with iliac interventions (20.6% vs 34.7%; P < .001 for all). Protamine was used less often with VCDs (19.1% vs 25.6%; P < .001). Overall, 2003 hematomas had developed (2.4%), of which 278 (13.9%) had required thrombin or surgical intervention. Compared with MC, the use of any VCD had resulted in fewer hematomas (1.7% vs 3.6%; P < .001) and fewer hematomas requiring intervention (0.2% vs 0.5%; P < .001). When divided by hemostatic technique, the rate of the development of any hematoma was as follows: MC, 3.6%; VCD A, 1.4%; VCD B, 1.2%; VCD C, 2.3%; and VCD D, 1.1% (P < .001). The rate of hematomas requiring intervention was as follows: MC, 0.5%; VCD A, 0.2%; VCD B, 0.2%; VCD C, 0.3%; and VCD D, 0.1% (P < .001). Access site stenosis/occlusion was similar between the MC and any VCD groups (0.2% vs 0.2%; P = .12). Multivariable analysis demonstrated that any VCD use and the use of the individual VCDs compared with MC were independently associated with the development of fewer hematomas. The incidence of access site stenosis/occlusion was similar between the use of any VCD and MC. The matched analysis revealed similar findings. CONCLUSIONS:Although the overall rates of hematomas requiring intervention were low regardless of hemostatic technique, VCD use, irrespective of type, compared favorably with MC, with significantly fewer access site complications after PVI.
PMID: 35618194
ISSN: 1097-6809
CID: 5248062

Thoracic Aortic Aneurysm Sac Remodeling After Thoracic Endovascular Aortic Repair Affects Late Outcomes After Repair [Meeting Abstract]

Patel, P; Marcaccio, C; O'Donnell, T; Elmously, A; Garg, K; Schermerhorn, M; Takayama, H; Patel, V
Background: Prior studies have demonstrated that aneurysm sac expansion and failure of sac regression after endovascular aortic repair is associated with higher rates of late mortality and reinterventions. However, the effect of aneurysm sac remodeling on late outcomes after thoracic endovascular aortic repair (TEVAR) is not well-understood.
Method(s): We identified all patients who underwent TEVAR for degenerative aortic aneurysm in the VQI from 2011 to 2018 with 1-year follow-up imaging (+/-6 months) and linkage to Medicare claims data. Sac remodeling was defined as sac expansion (>=5 mm increase), sac stable (<5 mm change), or sac regression (>=5 mm decrease). Mid-term survival, rupture, and reintervention rates were also assessed using Kaplan-Meier estimates. Cox regression was used to assess the impact of sac behavior on midterm outcomes.
Result(s): Among 574 patients, 19% demonstrated sac expansion. Aortic diameter was smallest in patients with sac expansion (expansion 51 mm vs stable/regression 57 mm; P <.001). Sac expansion had the highest rate of any completion endoleak (13% vs 5%; P =.004) and type II completion endoleak (7.8% vs 2.2%; P =.006). An aortic diameter of 65 mm or greater was associated with higher odds of sac regression or stable sac (odds ratio [OR], 2.8; 95% confidence interval [CI], 1.2-6.7; P =.020), while any completion endoleak was associated with higher odds of sac expansion (OR, 3.4; 95% CI, 1.3-8.9; P =.010). Sac expansion trended toward a higher risk of 5-year mortality (21% vs 13%; adjusted hazard ratio, 1.8; 95% CI, 0.9-3.4; P =.079) (Figure) and late rupture (12% vs 4.6%; HR, 3.5; 95% CI, 0.9-13; P =.063). Additionally, sac expansion was associated with higher risk of late reintervention (78% vs 36%; adjusted hazard ratio, 3.0; 95% CI, 18-5.1; P <.001).
Conclusion(s): Sac expansion after TEVAR is associated with increased risk of mid-term rupture and reintervention. Furthermore, completion endoleak is associated with higher odds of sac expansion during follow-up. Further study is warranted to determine if shorter interval follow-up in patients at risk for sac expansion can improve late rupture rates in these patients. [Formula presented]
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EMBASE:2019819847
ISSN: 1097-6809
CID: 5512712