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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

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

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.
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EMBASE:2019819768
ISSN: 1097-6809
CID: 5512732

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

Hypogastric Artery Salvage Associated with Decreased Postoperative Cardiac and Renal Complications [Meeting Abstract]

Ding, J; Patel, P; Rao, A; Krimbill, J; Horn, K; Morrissey, N; Bajakian, D; Garg, K; Siracuse, J; Patel, V
Background: Endovascular aortic aneurysm repair (EVAR) for aortoiliac aneurysms may require sacrifice of the hypogastric artery (HA) or use of iliac branch devices (IBD) to salvage antegrade flow through the HA.
Method(s): We identified all patients who underwent elective EVAR for aortoiliac aneurysms in the Society for Vascular Surgery-Vascular Quality Initiative (2014-2021). Patients were categorized as unilateral/bilateral IBD, bilateral HA sacrifice, or mixed (unilateral HA sacrifice or one-sided IBD/one-sided HA sacrifice). HA sacrifice was defined as coil embolization, Amplatzer plug, or coverage of HA. We compared postoperative outcomes, aneurysm sac remodeling, and late survival across the three groups. Logistic regression and Cox regression were used to identify independent effect of HA patency on outcomes of interest.
Result(s): Among 2822 patients undergoing EVAR for aortoiliac aneurysms, after EVAR 29% had bilateral HA patency, 64% had mixed repair, 7% had bilateral HA sacrifice. Patients with bilateral HA patency had smaller aortic diameter (bilateral patency 5.0 cm vs mixed repair 5.2 cm vs bilateral sacrifice 5.2 cm; P <.001) and fewer concomitant iliac artery and HA aneurysms (14% vs 16% vs 23%; P <.001). Unilateral and bilateral HA patency was associated with lower odds of major adverse cardiac events and postoperative renal complications (Table). There was no association between HA patency and postoperative mortality (0.6% vs 1.2% vs 1.1%; P =.35), leg ischemia (1.0% vs 1.0% vs 1.1%; P =.98), or mesenteric ischemia (0.2% vs 0.3% vs 0.5%; P =.80). There were no differences in 1-year sac shrinkage (>=5 mm decrease) (39% vs 40% vs 45%; P =.580) or 5-year survival (92% vs 94% vs 89%; P =.435).
Conclusion(s): In patients with aortoiliac aneurysms, bilateral HA patency was associated with lower postoperative major adverse cardiac events and renal complications. Salvage of the HA is important for quality of life and functional capacity, but future studies with larger sample sizes are needed. [Formula presented]
Copyright
EMBASE:2019819844
ISSN: 1097-6809
CID: 5512722

Urgent Endarterectomy for Symptomatic Carotid Occlusion Is Associated With a High Mortality [Meeting Abstract]

Schlacter, J; Rockman, C; Siracuse, J; Patel, V; Johnson, W; Jacobowitz, G; Garg, K
Background: Interventions for carotid occlusions are infrequently undertaken and the outcomes are poorly defined. We sought to study patients undergoing urgent carotid revascularization for symptomatic occlusions.
Method(s): The Society for Vascular Surgery Vascular Quality Initiative was queried from 2003 to 2020 to identify patients with carotid occlusions undergoing carotid endarterectomy. Only symptomatic patients undergoing urgent interventions, defined within 24 hours of presentation, were included in this analysis. This cohort was compared to patients undergoing urgent intervention for severe stenosis (>=80%). Patients were identified based on computed tomography and magnetic resonance imaging, only. The primary end points were perioperative stroke, death, myocardial infarction (MI), and composite outcomes.
Result(s): A total of 390 patients were identified who underwent urgent carotid endarterectomy for symptomatic occlusions. The mean age was 67.4 +/- 10.2 years with a range from 39 to 90 years. The cohort was predominantly male (60%), and had significant risk factors for cerebrovascular disease, including hypertension (87.4%), diabetes (34.4%), coronary artery disease (21.6%), current smoking (38.7%), chronic obstructive pulmonary disease (21.6%), and congestive heart failure (10.3%). Medications included statin therapy (78.6%), P2Y12 inhibitors (32.0%), aspirin (77.9%) and renin-angiotensin inhibitor use (43.7%). The perioperative rate of neurologic events was 4.9%%, associated mortality was 2.8% and rate of MI was 1.0%. The composite end point of stroke/death/MI was 7.7%. When compared to patients undergoing urgent endarterectomy for severe stenosis (>=80%), the two cohorts were well matched with regards to risk factors, but the severe stenosis cohort appeared to be better medically managed based on reported medications. In the severe stenosis group, the perioperative rate of neurologic events was 3.3%, associated mortality was 0.9% and rate of MI was 1.2%. The perioperative outcomes were significantly worse for the carotid occlusion cohort, primarily driven by the perioperative mortality, which was nearly threefold, 2.8% versus 0.9% (P <.001). The composite end point of stroke/death/MI was also significantly worse in the occlusion cohort (7.7% vs 4.9%; P =.014).
Conclusion(s): Revascularization for symptomatic carotid occlusion constitutes approximately 2% of carotid interventions captured in the Vascular Quality Initiative, affirming the rarity of this undertaking. These patients have acceptable rates of perioperative neurologic events but are at an elevated risk of overall perioperative adverse events, primarily driven by a significantly higher mortality. While intervention for a symptomatic carotid occlusion may be performed with acceptable rate of perioperative complications, judicious patient selection is warranted in this high-risk cohort.
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EMBASE:2019817685
ISSN: 1097-6809
CID: 5512762

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

The Impact of Large-Bore Access Complications on Outcomes of Patients Undergoing Thoracic Endovascular Aortic Repair [Meeting Abstract]

Rao, A; Patel, P; Mehta, A; Bajakian, D; Morrissey, N; Iannuzzi, J; Garg, K; Schermerhorn, M; Siracuse, J; Takayama, H; Patel, V
Background: Thoracic endovascular aortic repair (TEVAR) is increasingly used to treat aortic dissections and aneurysms. Access-related complications remain a common source of morbidity and mortality following TEVAR. Therefore, this study aims to determine major risk factors predicting postoperative access complications and 3-year survival in patients with access complications.
Method(s): We identified all patients undergoing TEVAR in the Vascular Quality Initiative from July 2010 to August 2021, excluding those converted to open repair. We defined access complication as postoperative occlusion, wound infection, hematoma, or unplanned conversion to open cutdown. The primary outcome was 3-year survival and the secondary outcome was postoperative mortality. Mixed effects logistic regression modelling with physician level clustering was used to identify factors associated with access complications and postoperative mortality. Kaplan-Meier estimates and Cox proportional hazards models were used for analysis of three-year survival.
Result(s): Of 18,172 patients, 1584 (8.7%) had access complications. Bilateral percutaneous access was obtained in 68% of patients, one percutaneous and one open in 14%, and bilateral open access in 13%. Patients with access complications were older (70 +/- 0.6 years vs 66 +/- 0.2 years; P <.01) and female (50% vs 34%; P <.01). Patients with access complications experienced higher postoperative mortality (12% vs 4.6%; P <.01), major adverse cardiac event (17% vs 6.6%; P <.01), reintervention (22% vs 10%; P <.01), and spinal ischemia (7.0% vs 2.1%; P <.01). After adjustment, factors associated with access complication include female sex (odds ratio [OR], 2.2; 95% confidence interval [CI], 1.9-2.6; P <.01) and obesity (OR, 1.2; 95% CI, 1.0-1.4; P =.02). Access complication was independently associated with postoperative mortality (OR, 2.5; 95% CI, 2.0-3.0; P <.01). Bilateral cutdown was associated with lower mortality in male patients (OR, 0.55; 95% CI, 0.34-0.90; P =.02), but not in female patients (OR, 2.1; 95% CI, 1.1-4.3; P =.03). Last, access complications were associated with higher 3 -year mortality (hazard ratio, 1.6; 95% CI, 1.3-1.8; P <.01).
Conclusion(s): Access complications when unexpected are associated with adverse postoperative and three-year outcomes. Female sex is associated with higher rates of access complications, suggesting the need for devices tailored to female anatomy.
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EMBASE:2019817713
ISSN: 1097-6809
CID: 5512752

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]
Copyright
EMBASE:2019819847
ISSN: 1097-6809
CID: 5512712

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