Clinical Impact of an Enhanced Recovery Program for Lower-extremity Bypass.

OBJECTIVE: To determine the association of Enhanced Recovery Program (ERP) implementation with length of stay (LOS) and perioperative outcomes after lower-extremity bypass (LEB). BACKGROUND: ERPs have been shown to decrease hospital LOS and improve perioperative outcomes, but their impact on patients undergoing vascular surgery remains unknown. METHODS: Patients undergoing LEB who received or did not receive care under the ERP were included; pre-ERP (January 1, 2016-May 13, 2018) and ERP (May 14, 2018-July 31, 2022). Clinicopathologic characteristics and perioperative outcomes were analyzed. RESULTS: Of 393 patients who underwent LEB [pre-ERP: n = 161 (41%); ERP: n = 232 (59%)], most were males (n = 254, 64.6%), White (n = 236, 60%), and government-insured (n = 265, 67.4%). Pre-ERP patients had higher Body Mass Index (28.8 ± 6.0 vs 27.4 ± 5.7, P = 0.03) and rates of diabetes (52% vs 36%, P = 0.002). ERP patients had a shorter total [6 (3-13) vs 7 (5-14) days, P = 0.01) and postoperative LOS [5 (3-8) vs 6 (4-8) days, P < 0.001]. Stratified by indication, postoperative LOS was shorter in ERP patients with claudication (3 vs 5 days, P = 0.01), rest pain (5 vs 6 days, P = 0.02), and tissue loss (6 vs 7 days, P = 0.03). ERP patients with rest pain also had a shorter total LOS (6 vs 7 days, P = 0.04) and lower 30-day readmission rates (32%-17%, P = 0.02). After ERP implementation, the average daily oral morphine equivalents decreased [median (interquartile range): 52.5 (26.6-105.0) vs 44.12 (22.2-74.4), P = 0.019], while the rates of direct discharge to home increased (83% vs 69%, P = 0.002). CONCLUSIONS: This is the largest single-center cohort study evaluating ERP in LEB, showing that ERP implementation is associated with shorter LOS and improved perioperative outcomes.

Preoperative risk factors for 1-year mortality in patients undergoing fenestrated endovascular aortic aneurysm repair in the US Aortic Research Consortium.

BACKGROUND: Early survival (1-year) after elective repair of complex abdominal aortic aneurysms (AAA) or thoracoabdominal aortic aneurysms (TAAA) can be used as an indicator of successful repair and provides a reasonable countermeasure to the annual rupture risk based on diameter. We aimed to identify preoperative factors associated with 1-year mortality after fenestrated or branched endovascular aortic repair (F/BEVAR) and develop a predictive model for 1-year mortality based on patient-specific risk profiles. METHODS: The US-Aortic Research Consortium database was queried for all patients undergoing elective F/BEVAR for complex AAA (cAAA) or TAAA from 2005 to 2022. The primary outcome was 1-year survival based on preoperative risk profile. Multivariable Cox regression was used to determine preoperative variables associated with 1-year mortality overall and by extent of aortic pathology. Logistic regression was performed to build a predictive model for 1-year mortality based on number of risk factors present. RESULTS: A total of 2099 patients met the inclusion criteria for this study (cAAA: n = 709 [34.3%]; type 1-3 TAAA: n = 777 [37.6%]; type 4-5 TAAA: n = 580 [28.1%]). Multivariable Cox regression identified the following significant risk factors associated with 1-year mortality: current smoker, chronic obstructive pulmonary disease, congestive heart failure (CHF), aortic diameter >7 cm, age >75 years, extent 1-3, creatinine >1.7 mg/dL, and hematocrit <36%. When stratified by extent of aortic involvement, multivariable Cox regression revealed risk factors for 1-year mortality in cAAA (CHF maximum aortic diameter >7 cm, hematocrit <36 mg/dL, and current smoking status), type 1-3 TAAA (chronic obstructive pulmonary disease, CHF, and age >75 years), and type 4-5 TAAA (age >75 years, creatinine >1.7 mg/dL, and hematocrit <36 mg/dL). Logistic regression was then used to develop a predictive model for 1-year mortality based on patient risk profile. Appraisal of the model revealed an area under the curve of 0.64 (P < .001), and an observed to expected ratio of 0.85. CONCLUSIONS: This study describes multiple risk factors associated with an increase in 1-year mortality after F/BEVAR. Given that elective repair of cAAA or TAAA is offered to some patients in whom future rupture risk outweighs operative risk, these findings suggest that highly comorbid patients with smaller aneurysms may not benefit from repair. Descriptive and predictive models for 1-year mortality based on patient risk profiles can serve as an adjunct in clinical decision-making when considering elective F/BEVAR.

Occurrence, predictors, and management of late vascular complications following extracorporeal membrane oxygenation.

OBJECTIVE: Vascular complications (VCs) associated with extracorporeal membrane oxygenation (ECMO) during index hospitalization are prevalent and associated with increased mortality. Few studies have evaluated late VCs following ECMO; this study aims to assess occurrence and management practices of late VCs following discharge. METHODS: A retrospective single-institution review was performed of all patients surviving initial hospitalization after being cannulated for central or peripheral veno-venous (VV) or veno-arterial (VA) ECMO between January 1, 2019, and December 31, 2020. Primary outcomes were to categorize and determine the rate of late VCs. Late VCs were defined as any cannulated vessel injury resulting from ECMO cannulation presenting after discharge from index hospitalization. Analysis was conducted by cannulated vessel and stratified by VV or VA ECMO configurations. RESULTS: A total of 229 patients were identified, of which 50.6% (n = 116) survived until discharge. Late VCs occurred in 7.8% of the surviving cohort (n = 9/116); with a median time until presentation of 150 days (interquartile range, 83-251 days). The most common late VC was infection (n = 5; 55.6%) followed by progression to limb-threatening ischemia (n = 4; 44.4%). Urgent procedures were required in 55.6% of patients (n = 5), whereas 44.4% (n = 4) were elective interventions. Interventions performed for management of late VCs included lower extremity arterial revascularization (n = 6; 66.7%), major (n = 1; 11.1%) or minor amputation (n = 1; 11.1%), and wound debridement (n = 1; 11.1%). The majority of patients presenting with late VCs had initially been cannulated for peripheral VA ECMO (n = 8; 88.9%), and one patient (11.1%) was cannulated for peripheral VV ECMO. VCs during index hospitalization were seen in 77.8% of patients (n = 7) returning with late VCs. Odds for late VCs were significantly increased in patients that had been cannulated for ECMO as part of extracorporeal cardiopulmonary resuscitation (odds ratio, 8.4; P = .016) and in cases where patients had experienced an index VC during index hospitalization (odds ratio, 19.3; P = .001). CONCLUSIONS: Late vascular complications after peripheral ECMO cannulation are not rare, particularly after arterial cannulation. Patients should be followed closely early after surviving ECMO with wound evaluation and formal assessment of perfusion with ankle-branchial indices in the cannulated limb.

Prospective randomized pilot trial comparing prophylactic and therapeutic cerebrospinal fluid drainage during complex endovascular thoracoabdominal aortic aneurysm repair.

BACKGROUND: Endovascular techniques have transformed the management of thoracoabdominal aortic aneurysms (TAAAs). However, spinal cord ischemia (SCI) remains a prevalent and devastating complication. Prophylactic drainage of cerebrospinal fluid (CSF) is among the proposed strategies for prevention of SCI. Although prophylactic CSF drainage is widely used and conceptually attractive, prophylactic CSF drains have not been demonstrated to definitively prevent the occurrence nor mitigate the severity of SCI in endovascular TAAA repair. Whether or not outcomes of prophylactic drains are superior to therapeutic drains remains unknown. This pilot study was performed to determine the feasibility of a randomized clinical trial designed to investigate the role of prophylactic vs therapeutic CSF drains in the prevention of SCI in patients undergoing endovascular TAAA repair using branched and fenestrated endovascular aortic repair (FBEVAR). METHODS: This was a prospective multicenter randomized pilot clinical trial conducted at The University of Alabama at Birmingham and The University of Massachusetts. Twenty patients were enrolled and randomized to either the prophylactic drainage or therapeutic drainage groups, prior to undergoing FBEVAR for extensive TAAAs and arch aortic aneurysms. This was a pilot feasibility study that was not powered to detect statistical differences in clinical outcomes. The primary outcome was feasibility of randomization and compliance with a shared lumbar drain protocol. Secondary outcomes included rate of drain complications and SCI. RESULTS: Twenty patients were enrolled and successfully randomized, without any crossovers, to either the control cohort (n = 10), without prophylactic drains, or the experimental cohort (n = 10), with prophylactic drains. There were no differences in age, comorbidities, or history of prior aortic surgery across the cohorts. All patients were treated with FBEVAR. Aneurysm classifications were as follows: Extent I (10%), Extent II (50%), Extent III (35%), and Extent IV (5%). The average length of aortic coverage was 207 ± 21.6 mm. The length of aortic coverage did not vary across cohorts, nor did procedural times or blood loss volume. Compliance with the SCI prevention protocol was 100% across both groups. Within the prophylactic drain cohort, one patient experienced an adverse event related to lumbar drain placement, manifested as an epidural hematoma requiring laminectomy, without neurologic deficit (n = 1/10; 10%). There was one SCI event (n = 1/20; 5%), which occurred in the prophylactic drain cohort on postoperative day 9 following an episode of hypotension related to a gastrointestinal bleed. CONCLUSIONS: The role of prophylactic CSF drains for the prevention of SCI following endovascular TAAA repair is a topic of ongoing research, with many current practices based on expert opinion and experience, rather than rigorous scientific data. This study demonstrates the feasibility of a multicenter randomized clinical trial to evaluate the role of prophylactic vs therapeutic CSF drains in the prevention of SCI in patients undergoing endovascular TAAA repair.

Treatment Location Variation for Chronic Limb-Threatening Ischemia in Patients With Kidney Failure.

INTRODUCTION: End-stage kidney disease (ESKD) is an established risk factor for chronic limb-threatening ischemia (CLTI). Procedural location for ESKD patients has not been well described. This study aims to examine variation in index procedural location in ESKD versus non-ESKD patients undergoing peripheral vascular intervention for CLTI and identify preoperative risk factors for tibial interventions. METHODS: Chronic limb-threatening ischemia (CLTI) patients were identified in the Vascular Quality Initiative (VQI) peripheral vascular intervention dataset. Patient demographics and comorbidities were compared between patients with and without ESKD and those undergoing index tibial versus nontibial interventions. A multivariable logistic regression evaluating risk factors for tibial intervention was conducted. RESULTS: A total of 23,480 procedures were performed on CLTI patients with 13.6% (n = 3154) with ESKD. End-stage kidney disease (ESKD) patients were younger (66.56 ± 11.68 versus 71.66 ± 12.09 y old, P = 0.019), more often Black (40.6 versus 18.6%, P < 0.001), male (61.2 versus 56.5%, P < 0.001), and diabetic (81.8 versus 60.0%, P < 0.001) than non-ESKD patients. Patients undergoing index tibial interventions had higher rates of ESKD (19.4 versus 10.6%, P < 0.001) and diabetes (73.4 versus 57.5%, P < 0.001) and lower rates of smoking (49.9 versus 73.0%, P < 0.001) than patients with nontibial interventions. ESKD (odds ratio (OR) 1.67, 95% confidence interval (CI) 1.52-1.86, P < 0.001), Black race (OR 1.19, 95% CI 1.09-1.30, P < 0.001), and diabetes (OR 1.82, 95% CI 1.71-2.00, P < 0.001) were risk factors for tibial intervention. CONCLUSIONS: Patients with ESKD and CLTI have higher rates of diabetes and tibial disease and lower rates of smoking than non-ESKD patients. Tibial disease was associated with ESKD, diabetes, and Black race.

Investigating glycemic control in patients undergoing lower extremity bypass within an enhanced recovery pathway at a single institution.

BACKGROUND: Enhanced recovery pathways (ERPs) aim to lower perioperative stress to facilitate recovery. Limited fasting combined with carbohydrate loading is a common ERP element. The effect of limited fasting has not been elucidated in patients with diabetes. Given the known deleterious effects of poor glycemic control in the perioperative period, such as increased rates of surgical site infection, the associations of preoperative limited fasting with perioperative glycemic control and early outcomes after lower extremity bypass (LEB) were investigated. METHODS: A single institutional retrospective review of patients who underwent infrainguinal LEB from 2016 to 2022 was performed. The ERP was initiated in May 2018. Patients were stratified by diabetes diagnosis and preoperative hemoglobin A1C (HbA1C) levels. Perioperative glycemic control was compared between the limited fasting and traditional fasting patients (nil per os at midnight). Limited fasting was defined as a clear liquid diet until 2 hours before surgery with recommended carbohydrate loading consisting of 400 cc of a clear sports drink (approximately 30 g of carbohydrates). All limited fasting patients were within the ERP. Early perioperative hyperglycemia (EPH) was defined as blood glucose of >180 mg/dL within the first 24 hours of surgery. Perioperative outcomes such as surgical site infection, readmission, reinterventions, and complications were also compared. RESULTS: A total of 393 patients were included (limited fasting patients N = 135; traditional fasting patients N = 258). A trend toward EPH was seen in all limited fasting groups. Evaluating limited fasting within diabetic patients revealed that 74.5% of limited fasting-diabetic patients had EPH compared with 49.6% of traditional fasting-diabetic patients (P = .001). When stratified by the HbA1C level, a significantly higher rate of EPH was seen in the HbA1c >8.0% groups, with 90.5% in the limited fasting patients compared with 67.9% in traditional fasting patients (P = .05). Limited fasting-diabetic patients experience a longer postoperative length of stay at 5.0 days (interquartile range: 3, 9) vs 4.0 days (2, 6) in nondiabetic patients (P = .016). CONCLUSIONS: ERP limited fasting was associated with early perioperative hyperglycemia after LEB, particularly in patients with HbA1C >8.0%. Due to the high prevalence of diabetic patients undergoing LEB under ERP, the role of limited fasting and common glycemic elements of ERP may need to be re-evaluated in this subpopulation.

Aneurysm extent-based mortality differences in complex endovascular repair of thoracoabdominal aneurysms in the Vascular Quality Initiative and the United States Aortic Research Consortium.

BACKGROUND: Endovascular management of thoracoabdominal aneurysms (TAAA) is becoming more common. Technological advances including custom devices under the Physician-Sponsored Investigational Device Exemption (PS-IDE), physician-modified endografts (PMEG), and parallel stenting techniques have expanded the extent of disease that is amenable to endovascular treatment. Patients within the PS-IDE studies are a highly selected group of patients, whereas patients treated with PMEG as captured within the Society for Vascular Surgery Vascular Quality Initiative (SVS VQI) represent a real-world experience. Research within both the SVS VQI on PMEG and the US Aortic Research Consortium (US-ARC) has demonstrated a relationship between extent of aneurysmal disease and mortality after complex endovascular TAAA repair, but no direct comparison of these cohorts has been conducted. In this study, we sought to compare outcomes of custom PS-IDE devices with off-label uses of commercially available devices for the endovascular management of TAAAs. METHODS: A retrospective review of patients presenting for elective endovascular TAAA repair for asymptomatic disease between 2011 and 2019 was conducted within both the SVS VQI registry and the US-ARC. Patients within the SVS VQI registry were treated with either PMEG or with parallel stenting techniques. Patients within the US-ARC were treated with PS-IDE custom devices. The extent of aneurysm disease was defined by the deployment zones documented for the devices entered in the registry using Crawford extents I to V. Primary outcomes were 30-day and 1-year mortality rates. RESULTS: A total of 3212 patients were included in the study: 1571 PMEG/parallel stenting within the VQI registry and 1641 with PS-IDE within the US-ARC database. The majority of patients presented with extent IV aneurysms (n = 1827 [57%]), with extent IV aneurysms being slightly more prevalent within the US-ARC cohort. Maximal aneurysm diameter within each extent did not vary between the US-ARC and VQI cohorts. Across all patients, the 30-day mortality was 4.4% and the 1-year mortality was 12.2%. Unadjusted mortality at 30-days was 6.7% within the VQI, and 2.2% in the US-ARC (P < .001). The unadjusted 1-year mortality was 14.3% within the VQI and 10.2% within the US-ARC (P < .001). When adjusted for aneurysm extent, similar differences in 30-day and 1-year survivals were identified. CONCLUSIONS: Patients treated in PS-IDE studies had better 30-day and 1-year survival rates compared with those treated with a similar extent of disease using off-label approaches in a real-world registry. These differences are complex and likely associated with a number of factors, including arterial anatomy, patient comorbidities, device construct, and volume outcomes, as well as complex and unmeasurable surgeon- and patient-specific factors.

Predictors and outcomes of spinal cord injury following complex branched/fenestrated endovascular aortic repair in the US Aortic Research Consortium.

OBJECTIVE: Spinal cord ischemia (SCI) is a well-known complication of thoracoabdominal aortic aneurysm repair and is associated with profound morbidity and mortality. The purpose of this study was to describe predictors for the development of SCI, as well as outcomes for patients who develop SCI, after branched/fenestrated endovascular aortic repair in a large cohort of centers with adjudicated physician-sponsored investigational device exemption studies. METHODS: We used a pooled dataset from nine US Aortic Research Consortium centers involved in investigational device exemption trials for treatment of suprarenal and thoracoabdominal aortic aneurysms. SCI was defined as new transient weakness (paraparesis) or permanent paraplegia after repair without other potential neurological etiologies. Multivariable analysis was performed to identify predictors of SCI, and life-table analysis and Kaplan-Meier methodologies were used to evaluate survival differences. RESULTS: A total of 1681 patients underwent branched/fenestrated endovascular aortic repair from 2005 to 2020. The overall rate of SCI was 7.1% (3.0% transient and 4.1% permanent). Predictors of SCI on multivariable analysis were Crawford Extent I, II, and III distribution of aortic disease (odds ratio [OR], 4.79; 95% confidence interval [CI], 4.77-4.81; P < .001), age ≥70 years (OR, 1.64; 95% CI, 1.63-1.64; P = .029), packed red blood cell transfusion (OR, 2.00; 95% CI, 1.99-2.00; P = .001), and a history of peripheral vascular disease (OR, 1.65; 95% CI, 1.64-1.65; P = .034). The median survival was significantly worse for patients with any degree of SCI compared with those without SCI (any SCI, 40.4 vs no SCI, 60.3 months; log-rank P < .001), and also worse in those with a permanent deficit (24.1 months) vs those with a transient deficit (62.4 months) (log-rank P < .001). The 1-year survival for patients who developed no SCI was 90.8%, compared with 73.9% in patients who developed any SCI. When stratified by degree of deficit, survival was 84.8% at 1 year for those who developed paraparesis and 66.2% for those who developed permanent deficits. CONCLUSIONS: The overall rates of any SCI at 7.1% and permanent deficit at 4.1% observed in this study compare favorably with those reported in contemporary literature. Our findings confirm that increased length of aortic disease is associated with SCI and those with Crawford Extent I to III thoracoabdominal aortic aneurysms are at highest risk. The long-term impact on patient mortality underscores the importance of preventive measures and rapid implementation of rescue protocols if and when deficits develop.

Differences in Long-Term Outcomes in End-Stage Kidney Disease Patients with Chronic Limb-Threatening Ischemia.

BACKGROUND: End-stage kidney disease (ESKD) is a risk factor for peripheral arterial disease and major adverse limb events following infra-inguinal bypass. Despite comprising an important patient population, ESKD patients are rarely analyzed as a subgroup and are underrepresented in vascular surgery guidelines. This study aims to compare the long-term outcomes of patients with and without ESKD undergoing endovascular peripheral vascular intervention (PVI) for chronic limb-threatening ischemia (CLTI). METHODS: CLTI patients with and without ESKD from 2007-2020 were identified in the Vascular Quality Initiative PVI dataset. Patients with prior bilateral interventions were excluded. Patients undergoing femoral-popliteal and tibial interventions were included. Mortality, reintervention, amputation, and occlusion rates at 21 months following intervention were examined. Statistical analyses were completed with the t-test, chi-square, and Kaplan-Meier curves. RESULTS: The ESKD cohort was younger (66.4 ± 11.8 vs. 71.6 ± 12.1 years, P < 0.001) with higher rates of diabetes (82.2 vs. 60.9%, P < 0.001) the non-ESKD cohort. Long-term follow-up was available for 58.4% (N = 2,128 procedures) of ESKD patients and 60.8% (N = 13,075 procedures) of non-ESKD patients. At 21 months, ESKD patients had a higher mortality (41.7 vs. 17.4%, P < 0.001) and a higher amputation rate (22.3 vs. 7.1%, P < 0.001); however, they had a lower reintervention rate (13.2 vs. 24.6%, P < 0.001). CONCLUSIONS: CLTI patients with ESKD have worse long-term outcomes at 2 years following PVI than non-ESKD patients. Mortality and amputation are higher with ESKD, while the reintervention rate is lower. Development of guidelines within the ESKD population has the potential to improve limb salvage.

The use of social media and virtual opportunities by integrated vascular surgery residency programs during the COVID-19 pandemic.

OBJECTIVES: The COVID-19 pandemic has significantly affected the 2021 match application cycle as in person sub-internships and interviews have been halted. Given the abrupt change, we aimed to characterize the utilization of social media and virtual open house platforms by integrated vascular surgery residency programs for outreach and networking during the pandemic for the 2021 cycle. METHODS: A list of accredited integrated vascular surgery residency programs was compiled using the Electronic Residency Application Service (ERAS) website provided by the Academic Medical Colleges (AMC). The social media platforms Twitter, Instagram, and Facebook were queried for accounts associated with the training programs or their associated institutional vascular surgery divisions. Each discovered account was surveyed for date of creation as well as posts outlining virtual interactive events such as open houses, meet-and-greets, and virtual sub-internship opportunities. Slopes of the curves representing total account numbers and account numbers on each platform were compared from pre-COVID to current day using linear regression and t-statistics. RESULTS: There were 64 integrated vascular surgery residency programs participating in the 2021 match cycle. 70.3% (N = 45) of programs had a social media presence on at least one of the three platforms. 54.7% (N = 35) of programs had an associated Twitter account. 43.9% (N = 28) of programs had an associated Instagram account. Six (9.4%) programs were found on Facebook. The number of social media accounts significantly increased from March 2020 (37 vs 69, p < .001) to March 2021. CONCLUSIONS: Vascular surgery residency programs have significantly increased use of social media platforms over a 12-month period beginning in March 2020, indicating adaptation to the restrictions prompted by the pandemic.

Association of Statin and Antiplatelet Use with Survival in Patients with AAA with and without Concomitant Atherosclerotic Occlusive Disease.

BACKGROUND: Statin therapy has been associated with improved clinical outcomes in patients undergoing treatment for vascular disease. Current guidelines do not address statin therapy in isolated abdominal aortic aneurysm (AAA) in the absence of other atherosclerotic cardiovascular disease (ASCVD). This study aims to elucidate effects of statin therapy, either as monotherapy or combined with antiplatelet agents, on the long-term mortality of patients with and without ASCVD who undergo elective AAA repair. METHODS: A retrospective review was performed on all AAA patients treated electively with endovascular (EVAR) and open aortic repair (OAR) in the Society for Vascular Surgery Vascular Quality Initiative from 2003-2020. Long-term mortality was evaluated based on the presence of statin and antiplatelet medication use at discharge stratified by those with and without a history of ASCVD. Unadjusted survival was estimated by Kaplan Meier methodology. Cox proportional hazards modeling was used to determine mortality risk after adjusting for key factors. RESULTS: A total of 47,012 AAA repairs were selected for analysis: 80.7% EVAR (N = 40,153) and 19.3% OAR (N = 6,859). EVAR patients on combined statin/antiplatelet (AP) therapy had significantly better survival irrespective of whether they had known ASCVD. In the presence of ASCVD, EVAR patients on statin alone had improved survival compared to those not on a statin (10.9 ± 0.5 vs. 10.5 ± 0.4 years, Log Rank < 0.001), with survival being even greater among those receiving combined statin/AP therapy (12.2 ± 0.2 vs. 10.5 ± 0.4 years, Log Rank < 0.001). In the absence of ASCVD, EVAR patients on statin alone also had better mean survival compared to patients not on a statin (8.7 ± 0.5 vs. 8.4 ± 0.4 years, Log Rank<.001), with higher survival among statin/AP therapy patients (9.4 ± 0.2 years vs. 8.7 ± 0.5 years, Log Rank < 0.001). Comparison of adjusted survival via Cox multivariable regression demonstrated a protective effect of statins (HR = 0.737, P = 0.04, vs. no medication) and combined statin/AP therapy (HR = 0.659, P = 0.001, vs no medication) in patients with ASCVD history. A similar protective effect (statin: HR 0.826, P = 0.05. Combination statin/AP: HR 0.726, P < 0.001, vs. no medication) was identified in patients without ASCVD history. Within the OAR cohort, statin therapy was not associated with improved survival among patients without ASCVD; however, combined statin/AP therapy had a protective effect for patients with a known ASCVD diagnosis. Based on KM analysis, OAR patients with ASCVD on combined statin/AP therapy had significantly higher mean survival compared to isolated statin therapy (12.7 ± 0.2 vs. 10.3 ± 0.65 years) and no medical therapy (10.5 ± 0.8 years, Log Rank < 0.001). In KM analysis, OAR patients without known ASCVD indications (N = 3591) had no significant survival differences based on the presence of combined statin/AP therapy (8.4 ± .07 vs. 8.5 ± .11 years, Log Rank = 0 638). CONCLUSION: Isolated statin therapy and combined statin/AP therapy showed significant survival benefit in all EVAR and OAR patients with ASCVD indications, as well as among EVAR patients without a known ASCVD diagnosis. OAR patients without ASCVD did not have a significant survival benefit from statin therapy, but low numbers in this group may have confounded the findings. Combined statin/AP therapy appears to have significant post-repair survival benefits even in isolated AAA without ASCVD, as demonstrated in post-EVAR patients in this study. Expansion of statin use recommendations within aneurysm treatment guidelines may be warranted.

Migration of High Cardiac Risk Patients from Open to Endovascular Procedures is Evident within the Society for Vascular Surgery Vascular Quality Initiative.

BACKGROUND: In this study, pre-operative medical complexity is estimated by the independently validated Vascular Quality Initiative VQI Cardiac Risk Index (CRI). This study aims to identify and correlate trends of CRI for open abdominal aortic aneurysm (OAR) with trends in the CRI for corresponding endovascular aortic repair (EVAR). This assessment of differences in estimated procedural risks will be used to support the theory that, patient migration is an important factor contributing to decreased POMI following open vascular procedures. METHODS: A retrospective review of VQI data from 2003 to 2020 for all patients undergoing elective aortic repairs (OAR and EVAR) was conducted. The CRI scoring developed for the open repair (oCRI) was applied to both the OAR and EVAR cohorts, with variables specific to EVAR translated from similar open repair factors in the model where feasible. To evaluate for changes across time, patients were grouped into Eras based on year of procedure, subsequently, univariate analysis of post-operative myocardial infarction (POMI) rates and CRI scores were perfomed between each era. RESULTS: A total of 56,067 elective aortic repairs were identified (83% EVAR, 17% OAR). Within the OAR cohort, the average oCRI estimate was 7.1% with significant decrease across the studied timeframe (8% ± 4.6%→6.9% ± 4.4%, P < 0.001), which corresponded to a significant decrease in observed clinical myocardial infarction (MI) rate (4.1%→1.4%, P < 0.001). Over that same time period, the open CRI was applied to the EVAR cohort, and the average oCRI estimate was 7.2% and showed a significant increase (6.6% ± 2.8%→7.2% ± 4.4%, P < 0.001). Within the EVAR cohort, the eCRI estimate did not show any significant changes over time (average 0.48%), while the actual rate of clinical MI showed a significant decrease (1.1%→0.3%, P = 0.002). Gap analysis was conducted within the EVAR cohort between CRI estimates of procedural risks from an open operation versus an EVAR, which demonstrated that patients within the EVAR cohort would, on an average, has had 6.7% higher risk of POMI had they undergone an open procedure. CONCLUSIONS: Paradigm shifts with regard to patient selection for aortic repair is evident within this large national cohort. Over time, OAR patients had fewer preoperative estimated cardiac comorbidities and there is a corresponding decrease in POMI rates. As high-risk patients migrate from OAR to EVAR, there has been a subsequent increase in EVAR estimated pre-operative risks as the patients become more medically high-risk. Despite increasing complexity, rates of POMI in EVAR significantly decreased, potentially explained by improved operative technique and peri-operative care.

Vagus nerve stimulation outcome prediction: from simple parameters to advanced models.

Since its approval as an adjunct treatment for refractory partial epilepsy, the positive effects of vagus nerve stimulation (VNS) on seizure frequency and severity have been supported by many studies. Seizure reduction of more than 50 % can be expected in at least 50 % of patients. However, a complete post-VNS seizure freedom is rarely achieved and 25 % of patients do not benefit from VNS. Our study provides an overview of the potential predictors of VNS response, from the most simple and basic data to sophisticated EEG processing studies and functional imaging studying brain connectivity. The data support better outcomes in younger patients with early VNS implantation, in patients with posttraumatic epilepsy or tuberous sclerosis, and in patients without bilateral interictal epileptiform discharges. The variability of heart activity has also been studied with some promising results. Because the generally accepted hypothesis of the VNS mechanism is the modulation of synaptic activity in multiple cortical and subcortical regions of the brain, the studies of brain response to external stimulation and/or of brain connectivity were used for models predicting the effect of VNS in individual patients. Although the predictive value of these models is high, the required special equipment and sophisticated mathematical tools limit their routine use (Ref. 58). Keywords: epilepsy, vagus nerve stimulation, response predictor, EEG.

Incidence and predictors of early and delayed renal function decline after aortic aneurysm repair in the Vascular Quality Initiative database.

BACKGROUND: Postoperative acute kidney injury (AKI) may complicate both open and endovascular aortic aneurysm repair (EVAR) and is associated with substantial morbidity, mortality, and health care expense. We aim to evaluate the incidence of postoperative AKI and factors associated with its occurrence and the effects of postoperative AKI on long-term renal function and mortality after open and EVAR in the Society for Vascular Surgery Vascular Quality Initiative registry. METHODS: Elective aneurysm cases were identified including thoracic endovascular aortic aneurysm repair (TEVAR) and complex endovascular aortic aneurysm repair (cEVAR), infrarenal endovascular repair (EVAR) and infrarenal open repair (OAR) from 2003 to 2019. The preoperative estimated glomerular filtration rate (eGFR) was calculated using the Modification of Diet in Renal Disease formula and stratified based on chronic kidney disease (CKD) grades. Postoperative AKI was defined per the Vascular Quality Initiative definition as a creatinine increase of 0.5 mg/dL or if postoperative dialysis was required. Patients on preprocedural hemodialysis and those with previous renal transplant were excluded. Demographics and procedural factors were evaluated for predicting in-hospital postoperative AKI (all approaches) and at 9 to 21 months of long-term follow-up (EVAR only) using logistic regression modeling. RESULTS: We identified a total of 2813 cEVAR, 2995 TEVAR, 39,945 EVAR, and 8143 OAR patients. Of those, postoperative AKI occurred in 377 cEVAR (13.5%), 199 TEVAR (6.7%), 1099 EVAR (2.8%), and 1249 OAR (15.5%). Risk factors for postoperative AKI across all groups were worse preoperative eGFR, total number of blood transfusions, perioperative anemia, reinterventions, and postoperative respiratory complications. Additional procedure-specific risk factors of postoperative AKI were preoperative hemoglobin of less than 10 and contrast volume of 125 to 150 mL, hypertension, a low ejection fraction, and a history of percutaneous revascularization for EVAR; for both EVAR/cEVAR, renal artery coverage was a risk factor, whereas for OAR, male sex, non-White race, hypertension, suprarenal aortic cross-clamp, and increased renal ischemic time were risk factors. Among 8133 EVAR patients with long-term follow-up, a decrease in kidney function occurred in 56.7% of patients with postoperative AKI vs 19.9% without postoperative AKI (P < .001). The following risk factors were associated with a decrease in renal function at long-term follow-up: postoperative AKI, a preoperative eGFR of less than 90, and hypertension. A preoperative hemoglobin of greater than 12 was protective. Postoperative AKI was associated with significantly lower survival compared with no postoperative AKI across all procedures (log rank <0.001). CONCLUSIONS: Postoperative AKI occurs more often in patients with worse preoperative renal function, lower preoperative hemoglobin, and in open surgeries with inter-renal or suprarenal cross-clamping. Importantly, postoperative AKI is associated with increased mortality across all types of aortic repair. Given the long-term impact of postoperative AKI on outcomes for all aortic repairs and the limitations of current insensitive functional indices, there is a need to seek more sensitive indicators of decreases in early renal structural in this population.

Thoracofemoral bypass outcomes in the Vascular Quality Initiative.

OBJECTIVE: Thoracofemoral bypass (TFB) has been used infrequently but is an alternative for select patients with aortoiliac occlusive disease. Limited data are available in the reported data regarding TFB, with all studies small, single-center series. We aimed to describe the perioperative and long-term survival, patency, and rate of major perioperative complications after TFB in a large national registry. METHODS: The Vascular Quality Initiative suprainguinal bypass module was used to identify patients who had undergone TFB for occlusive disease from 2009 to 2019. A descriptive analysis was performed to provide the rates of survival, patency, major complications, and freedom from major amputation in the perioperative period and at 1 year of follow-up. Major complications were compared by procedure indication, with categorical variables analyzed using χ2 tests and continuous variables using analysis of variance. Kaplan-Meier curve analysis was used to estimate survival at the 1- and 5-year follow-up intervals and freedom from major amputation at 1 year. RESULTS: A total of 154 TFB procedures were identified. Of the 154 patients, 59 (38.3%) had undergone previous inflow bypass and 22 (14.2%) had undergone previous leg bypass. The procedure indications included claudication (n = 66; 42.9%), rest pain (n = 59; 38.3%), tissue loss (n = 19; 12.3%), and acute limb ischemia (n = 10; 6.5%). Major complications (eg, wound infection, respiratory, major stroke, new dialysis, cardiac, embolic, major amputation, occlusion) occurred in 31.2% of the cohort. When examined by indication, the acute limb ischemia and claudication cohorts had an increased rate of major complications (acute limb ischemia, 60.0%; claudication, 34.8%; critical limb ischemia, 24.4%; P = .05). The survival rate at 30 days was 95.5%, with a Kaplan-Meier estimated 1-year survival rate of 92.7% ± 2.2%. Primary patency at discharge from the index hospitalization was 92.9% and 89.0% at 1 year. Postoperative major amputation was required for 1 patient during the index hospitalization, for a Kaplan-Meier estimated freedom from major amputation at 1 year of 97.1% ± 2.2%. Two patients developed in-hospital bypass occlusion and three patients developed occlusion within 1 year, for an overall freedom from occlusion rate of 96.8% at 1 year. CONCLUSIONS: TFB is associated with a high rate of perioperative major complications; however, the long-term survival and patency after TFB remained acceptable when performed for limb salvage. The high perioperative complication rates of TFB procedures performed for claudication suggest TFB should be used rarely in this population. These data can be used to counsel patients and aid in decision making before operative intervention.

The association between preoperative length of stay and surgical site infection after lower extremity bypass for chronic limb-threatening ischemia.

OBJECTIVE: Surgical site infection (SSI) is an important complication of lower extremity bypass (LEB) and the rate of SSI after LEB varies widely in the existing literature, ranging from 4% to 31%. Prolonged length of stay (LOS) has been implicated in the occurrence of SSI across multiple surgical disciplines. The impact of preoperative LOS in patients with chronic limb-threatening ischemia (CLTI) undergoing LEB is unknown. We examined the association of preoperative LOS on SSI after LEB. METHODS: A retrospective analysis of the Society for Vascular Surgery Vascular Quality Initiative Infrainguinal Bypass Registry identified patients undergoing elective LEB for chronic limb-threatening ischemia from 2003 to 2019. Patients undergoing LEB for acute limb ischemia, urgent/emergent procedures, aneurysm, or who had concomitant suprainguinal bypass were excluded. The primary outcome measure was postoperative SSI. Multivariable forward stepwise logistic regression was then performed including all variables with a P value of less than .10 in both matched and unmatched cohorts to evaluate for demographic and perioperative predictors of SSI. Propensity score matching was used to create matched cohorts of patients for each LOS group. RESULTS: A total of 17,883 LEB procedures were selected for inclusion: 0 days (12,362 LEB), 1 to 2 days (1737 LEB), and 3 to 14 days (3784 LEB). Patients with the greatest preoperative LOS were more likely to have vein mapping (0 days preoperative LOS, 66.3%; 1-2 days, 65.2%; 3-14 days, 73.2%; P < .01) or computed tomography angiography/magnetic resonance angiography (0 days, 32.1%; 1-2 days, 34.4%; 3-14 days, 38.4%; P < .01). Patients with 3 or more days of preoperative LOS had longer procedure lengths (0 days, 244 minutes; 1-2 days, 243 minutes; 3-14 days, 255 minutes; P < .01) and were more likely to have completion angiogram (0 days, 27.1%; 1-2 days, 29.5%; 3-14 days, 31.6%; P = .02). Multivariable logistic regression demonstrated that preoperative LOS of 3 to 14 days was associated with increased rate of SSI (odds ratio [OR], 1.92; 95% confidence interval [CI], 1.20-3.07; P = .01). Transfusion of 3 or more units (OR, 2.87; 95% CI, 1.89-4.36; P < .01) and prolonged procedure length (>220 minutes; OR, 1.86; 95% CI, 1.26-2.73; P < .01) were also significantly associated with postoperative SSIs. CONCLUSIONS: Many factors including preoperative comorbidities and operative complexity covary with preoperative LOS as risk factors for SSI. However, when patients are matched based on comorbidities and factors that would predict overall clinical complexity, preoperative LOS remains important in predicting SSI.

Trends in the use of cerebrospinal drains and outcomes related to spinal cord ischemia after thoracic endovascular aortic repair and complex endovascular aortic repair in the Vascular Quality Initiative database.

BACKGROUND: Spinal cord ischemia (SCI) is a dreaded complication of thoracic and complex endovascular aortic repair (TEVAR/cEVAR). Controversy exists surrounding cerebrospinal fluid drain (CSFD) use, especially preoperative prophylactic placement, owing to concerns regarding catheter-related complications. However, these risks are balanced by the widely accepted benefits of CSFDs during open repair to prevent and/or rescue patients with SCI. The importance of this issue is underscored by the paucity of data on CSFD practice patterns, limiting the development of practice guidelines. Therefore, the purpose of the present analysis was to evaluate the differences between patients who developed SCI despite preoperative CSFD placement and those treated with therapeutic postoperative CSFD placement. METHODS: All elective TEVAR/cEVAR procedures for degenerative aneurysm pathology in the Society for Vascular Surgery Vascular Quality Initiative from 2014 to 2019 were analyzed. CSFD use over time, the factors associated with preoperative prophylactic vs postoperative therapeutic CSFD placement in patients with SCI (transient or permanent), and outcomes were evaluated. Survival differences were estimated using the Kaplan-Meier method. RESULTS: A total of 3406 TEVAR/cEVAR procedures met the inclusion criteria, with an overall SCI rate of 2.3% (n = 88). The SCI rate decreased from 4.55% in 2014 to 1.43% in 2018. Prophylactic preoperative CSFD use was similar over time (2014, 30%; vs 2018, 27%; P = .8). After further exclusions to evaluate CSFD use in those who had developed SCI, 72 patients were available for analysis, 48 with SCI and prophylactic CSFD placement and 24 with SCI and therapeutic CSFD placement. Specific to SCI, the patient demographics and comorbidities were not significantly different between the prophylactic and therapeutic groups, with the exception of previous aortic surgery, which was more common in the prophylactic CSFD cohort (46% vs 23%; P < .001). The SCI outcome was significantly worse for the therapeutic group because 79% had documented permanent paraplegia at discharge compared with 54% of the prophylactic group (P = .04). SCI patients receiving a postoperative therapeutic CSFD had had worse survival than those with a preoperative prophylactic CSFD (50% ± 10% vs 71% ± 9%; log-rank P = .1; Wilcoxon P = .05). CONCLUSIONS: Prophylactic CSFD use with TEVAR/cEVAR remained stable during the study period. Of the SCI patients, postoperative therapeutic CSFD placement was associated with worse sustained neurologic outcomes and overall survival compared with preoperative prophylactic CSFD placement. These findings highlight the need for a randomized clinical trial to examine prophylactic vs therapeutic CSFD placement in association with TEVAR/cEVAR.

Carotid endarterectomy with concomitant distal endovascular intervention is associated with increased rates of stroke and death.

OBJECTIVE: Carotid endarterectomy (CEA) with concomitant distal endovascular intervention (CEA+D) is infrequently necessary but has often been used as a salvage maneuver when complications occur during CEA. The present study aimed to determine whether preoperative risk factors associated with CEA requiring CEA+D exist and to evaluate the outcomes compared with isolated CEA. METHODS: The Vascular Quality Initiative CEA registry was used to identify patients who had undergone CEA or CEA+D for asymptomatic or symptomatic carotid stenosis from 2013 to 2019. Data regarding distal intervention included whether angioplasty or stenting of the distal internal carotid artery (ICA) and/or bifurcation had been required. However, information regarding the indication or whether the intervention had been planned was not included. The χ2 test and analysis of variance were used to evaluate the categorical and continuous perioperative variables. Variables with P < .20 on univariate analysis were included in the multivariable analysis to assess for preoperative predictors of the need for CEA+D and the association with perioperative stroke. RESULTS: From 2013 to 2019, 327 CEA+D cases were identified and compared with 105,192 isolated CEA cases. The CEA+D patients were more likely to have undergone previous ipsilateral CEA (CEA, 1.8%; CEA+D, 4.9%; P < .01) and contralateral ICA occlusion (CEA, 4.6%; CEA+D, 11.0%; P < .01) but were less likely to have had ipsilateral stenosis ≥70% (CEA, 88.3%; CEA+D, 80.6%; P < .01). The preoperative factors associated with the need for CEA+D on multivariable analysis included previous peripheral vascular intervention, American Society of Anesthesiologists class ≥4, contralateral ICA occlusion, low-volume surgeon, and previous ipsilateral CEA. CEA+D was associated with significantly increased rates of stroke in both asymptomatic (CEA+D, 3.9%; CEA, 0.9%; P < .01) and symptomatic (CEA+D, 9.4%; CEA, 1.9%; P < .01) patients. CEA+D was associated with decreased rates of 30-day survival in both asymptomatic (CEA+D, 98.3%; CEA, 99.4%; P = .02) and symptomatic (CEA+D, 94.8%; CEA, 99.1%; P < .01) cohorts. On multivariable analysis, CEA+D remained significantly associated with stroke (odds ratio, 3.17; 95% confidence interval, 1.80-5.60; P < .01). Other factors significantly associated with perioperative stroke included procedure length >135 minutes, diabetes, hypertension, shunt for indication, symptomatic status, previous ipsilateral CEA, contralateral ICA occlusion, urgent or emergent procedure, intravenous medications for hemodynamic instability, and re-exploration at the initial operation. CONCLUSIONS: Although markers of more significant cardiovascular disease burden were associated with the use of CEA+D, their power to predict CEA+D use was limited. In cases in which CEA+D was used, CEA+D was associated with significantly greater rates of perioperative stroke and mortality compared with isolated CEA for both asymptomatic and symptomatic patients, which could be useful for framing the expected outcomes after these procedures.

Association between thoracoabdominal aneurysm extent and mortality after complex endovascular repair.

OBJECTIVE: Traditional open surgical repair of thoracoabdominal aortic aneurysms (TAAAs) has historically resulted in 30-day mortality rates ranging from 6% to 20%, depending on the Crawford anatomic extent. Although short-term survival is important, long-term survival is essential for patients to benefit from these often elective and potentially morbid procedures. The aneurysm extent affects the long-term survival after open repair; however, effect on endovascular repair is unknown and could influence the decision process for repair. We evaluated the association between aneurysm extent and survival and identified patient and perioperative factors associated with mortality after endovascular repair. METHODS: A retrospective cohort of patients treated for TAAAs recorded in the Society for Vascular Surgery Vascular Quality Initiative thoracic and complex endovascular aneurysm repair registry were evaluated. All patients treated for asymptomatic degenerative aneurysms from 2010 to 2019 were included. Crawford extent I to V was defined according to the proximal and distal landing zones documented in the registry. Patients without extension into the visceral aorta were used for comparison and categorized as having extent 0a or 0b, depending on the distal landing zone in the thoracic aorta. Kaplan-Meier plots were used to estimate survival, and Cox proportional hazard regression models were created to identify the predictors of mortality. RESULTS: From 2010 to 2019, 15,333 patients were entered into the registry, of whom 2062 met the inclusion criteria. The Crawford extent was 0a for 379, 0b for 848, I for 81, II for 98, III for 130, IV for 454, and V for 72. Three groups were created in accordance with the similar outcomes noted on a preliminary analysis: (1) extent 0a and 0b; (2) extent I, II, and III; and (3) extent IV and V. The mean survival time for the extent 0a and 0b group was 70.7 ± 1.43 months and was 48.6 ± 1.65 months for the extent I, II, and III group and 57.6 ± 1.24 months for the extent IV and V group. The corresponding 1-year mortality was 8.4%, 18.4%, and 7.8%. Cox regression analysis identified the following preoperative factors were associated with mortality: chronic obstructive pulmonary disease (odds ratio [OR], 1.70; P < .001), Crawford extent I to III (OR, 1.64; P = .015), preexisting chronic kidney disease (OR, 1.37; P = .024), and age per year (OR, 1.03; P < .001). A number of postoperative factors were also associated with mortality. CONCLUSIONS: Similar to open TAAA repair, patients with more extensive aortic disease treated with endovascular repair had worse 1-year and long-term survival. The extent of aortic disease and anticipated postoperative survival should factor prominently into the surgical decision-making process for elective endovascular TAAA repair.

Timing of thoracic endovascular aortic repair for uncomplicated acute type B aortic dissection and the association with complications.

OBJECTIVE: Previous publications have clearly established a correlation between timing of thoracic endovascular aortic repair (TEVAR) and complications after treatment of complicated acute type B aortic dissection (ATBAD). However, the temporal association of TEVAR with morbidity after uncomplicated presentations is poorly understood and has not previously been examined using real-world national data. Therefore, the objective of this analysis was to determine whether TEVAR timing of uncomplicated ATBAD (UATBAD) is associated with postoperative complications. METHODS: The Vascular Quality Initiative TEVAR and complex endovascular aneurysm repair registry was analyzed from 2010 to 2019. Procedures performed for non-dissection-related disease as well as for ATBAD with malperfusion or rupture were excluded. Because of inherent differences between timing cohorts, propensity score matching was performed to ensure like comparisons. Univariate and multivariable analysis after matching was used to determine differences between timing groups (symptom onset to TEVAR: acute, 1-14 days; subacute, 15-90 days) for postoperative mortality, in-hospital complications, and reintervention. RESULTS: A total of 688 cases meeting inclusion criteria were identified. After matching 187 patients in each of the 1- to 14-day and 15- to 90-day treatment groups, there were no statistically significant differences between groups. On univariate analysis, the 1- to 14-day treatment group had a higher proportion of cases requiring reintervention within 30 days (15.3%) compared with UATBAD patients undergoing TEVAR within 15 to 90 days (5.2%; P = .02). There was also a difference (P = .007) at 1 year, with 33.8% of the 1- to 14-day UATBAD patients undergoing reintervention compared with 14.5% for the 15- to 90-day group. There were no statistically significant differences on multivariable analysis for long-term survival, complications, or long-term reintervention. There was a trend toward significance (P = .08) with the 1- to 14-day group having 2.3 times the odds of requiring an in-hospital reintervention compared with the 15- to 90-day group. CONCLUSIONS: Timing of TEVAR for UATBAD does not appear to predict mortality or postoperative complications. However, there is a strong association between repair within 1 to 14 days and higher risk of reintervention. This may in part be related to the 1- to 14-day group's representing an inherently higher anatomic or physiologic risk population that cannot be entirely accounted for with propensity analysis. The role of optimal timing to intervention should be incorporated into future study design of TEVAR trials for UATBAD.