Vascular complications based on mode of extracorporeal membrane oxygenation.

BACKGROUND: Vascular complications remain a prevalent and devastating complication of extracorporeal membrane oxygenation (ECMO). Risks for vascular complications have risen as the volume and medical complexity of ECMO cases has rapidly increased in recent years. This study assesses occurrence and clinical impact of vascular complications across all ECMO modes and cannulation methods in a high-volume academic center. METHODS: A retrospective single-institution review was performed of all ECMO cannulations for central or peripheral venovenous (VV) or venoarterial (VA) ECMO in 2019-2020. Patients who expired during cannulation were excluded. Primary outcomes of vascular consultation rates at or after ECMO placement, limb loss, and mortality were assessed during index hospitalization. RESULTS: A total of 229 patients were identified during the 2-year study period. VA ECMO was used in the majority of patients (n = 137, 60%), with 83% (N = 114) undergoing peripheral cannulation. Vascular surgery was consulted in 54 (23.6%) patients. Complication rates ranged from 33.9% in peripheral VA cannulation to 7% in jugular VV cannulation. Overall, 65% of vascular consults required operative intervention; interventions were highest in peripheral VA ECMO (n = 30 of 114, 26.3%). Across all ECMO types, acute limb ischemia (ALI) was the most common complication (n = 38, 16.5%), with rates ranging from 26.1% in central VA ECMO to 4.8% in jugular VV ECMO. Distal antegrade perfusion catheters (DPCs) were employed in n = 68 of 114 (59.6%) of all peripheral VA ECMO cases. Prophylactic DPCs were found to be incorrectly placed in 10.2% (n = 7 of 68) of cases, which obscured the ability to fully evaluate the effect of prophylactic DPCs on reducing rates of ALI. Major amputation (Below Knee Amputation/Above Knee Amputation) occurred in six peripheral VA patients (5.3%), two central VA patients (8.65), and two femoral-femoral VV patients (4%). Patients with ALI experienced significantly lower rates of in-hospital survival in Kaplan-Meier analysis (32.5% vs 54%, log-rank = 0.023). CONCLUSIONS: This study highlights the prevalence of vascular complications, and their associated mortality impact, across all modes of ECMO and additionally identifies several areas for institutional performance improvement. ALI was the most common complication across all cohorts and was associated with decreased in-hospital survival. The impact of DPC on ALI was difficult to elucidate due to nonstandardized placement patterns and selective use. In the care of these medically complex patients on multidisciplinary teams, review of outcomes and group discussions targeting areas for improvement are critical to success; in this study, findings resulted in the development of a lower extremity perfusion management protocol.

In-situ bypass is associated with superior infection-free survival compared with extra-anatomic bypass for the management of secondary aortic graft infections without enteric involvement.

OBJECTIVE: The optimal revascularization modality following complete resection of aortic graft infection (AGI) without enteric involvement remains unclear. The purpose of this investigation is to determine the revascularization approach associated with the lowest morbidity and mortality using real-world data in patients undergoing complete excision of AGI. METHODS: A retrospective, multi-institutional study of AGI from 2002 to 2014 was performed using a standardized database. Baseline demographics, comorbidities, and perioperative variables were recorded. The primary outcome was infection-free survival. Descriptive statistics, Kaplan-Meier survival analysis, and univariate and multivariable analyses were performed. RESULTS: A total of 241 patients at 34 institutions from seven countries presented with AGI during the study period (median age, 68 years; 75% male). The initial aortic procedures that resulted in AGI were 172 surgical grafts (71%), 66 endografts (27%), and three unknown (2%). Of the patients, 172 (71%) underwent complete excision of infected aortic graft material followed by in situ (in-line) bypass (ISB), including antibiotic-treated prosthetic graft (35%), autogenous femoral vein (neo-aortoiliac surgery) (24%), and cryopreserved allograft (41%). Sixty-nine patients (29%) underwent extra-anatomic bypass (EAB). Overall median Kaplan-Meier estimated survival was 5.8 years. Perioperative mortality was 16%. When stratified by ISB vs EAB, there was a significant difference in Kaplan-Meier estimated infection-free survival (2910 days; interquartile range, 391-3771 days vs 180 days; interquartile range, 27-3750 days; P < .001). There were otherwise no significant differences in presentation, comorbidities, or perioperative variables. Multivariable Cox regression showed lower infection-free survival among patients with EAB (hazard ratio [HR], 2.4; 95% confidence interval [CI], 1.6-3.6; P < .001), polymicrobial infection (HR, 2.2; 95% CI, 1.4-3.5; P = .001), methicillin-resistant Staphylococcus aureus infection (HR, 1.7; 95% CI, 1.1-2.7; P = .02), as well as the protective effect of omental/muscle flap coverage (HR, 0.59; 95% CI, 0.37-0.92; P = .02). CONCLUSIONS: After complete resection of AGI, perioperative mortality is 16% and median overall survival is 5.8 years. EAB is associated with nearly a two and one-half-fold higher reinfection/mortality compared with ISB. Omental and/or muscle flap coverage of the repair appear protective.

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.

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.

Tibial bypass in patients with intermittent claudication is associated with poor outcomes.

OBJECTIVE: Given that intermittent claudication (IC) rarely progresses to chronic limb-threatening ischemia and limb loss, safety and durability of elective interventions for IC are essential. Whether patients with IC benefit from tibial intervention is controversial, and data supporting its utility are limited. Despite endovascular therapy expansion, surgical bypass is still commonly performed. We sought to assess outcomes of bypass to tibial arteries for IC. METHODS: The Vascular Quality Initiative (2003-2018) was queried for infrainguinal bypasses performed for IC. Perioperative and 1-year outcomes were compared between bypasses constructed to tibial and popliteal arteries. RESULTS: Of 5347 infrainguinal bypasses, 1173 (22%) and 4184 (78%) were tibial and popliteal bypasses, respectively. Overall, mean age was 65 ± 10 years, and patients were often men (72%) and current smokers (42%). Tibial bypasses commonly targeted posterior tibial (40%), tibioperoneal trunk (23%), and anterior tibial (19%) arteries. Great saphenous vein was more often used for tibial bypass than for popliteal bypass (78% vs 54%; P < .001). Patients undergoing tibial compared with popliteal bypass more often had impaired ambulation and prior ipsilateral bypasses and were less often taking antiplatelets and statins (all P < .05). In the perioperative period, tibial bypass patients had longer postoperative length of stay (4.5 ± 3.5 vs 3.5 ± 2.8 days), more pulmonary complications (1.3% vs 0.6%), and higher return to the operating room (7% vs 4%; all P < .05). Perioperative myocardial infarction (1.2% vs 0.8%; P = .19), stroke (0.4% vs 0.4%; P = .91), and mortality (0.3 vs 0.3%; P = .86) rates were similar between the cohorts. At 1 year, tibial compared with popliteal bypasses exhibited lower freedom from occlusion/death (81% vs 89%; P < .001), ipsilateral major amputation/death (90% vs 94%; P < .001), and reintervention/amputation/death (73% vs 80%; P < .001), but patient survival was similar (96% vs 97%; P = .07). On multivariable analysis, tibial compared with popliteal bypass was independently associated with increased occlusion/death (hazard ratio [HR], 1.65; 95% confidence interval [CI], 1.28-2.11; P < .001), major ipsilateral amputation/death (HR, 1.6; 95% CI, 1.12-2.19; P = .003), and ipsilateral reintervention/amputation/death (HR, 1.51; 95% CI, 1.28-1.79; P < .001), with similar patient survival. CONCLUSIONS: In patients with IC, tibial bypass was associated with poor outcomes, including major amputation. Surgeons should exhaust nonoperative therapies and present realistic outcome expectations to their patients before offering such intervention.

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.

Implementation of an enhanced recovery program for lower extremity bypass.

OBJECTIVE: Enhanced recovery programs (ERPs) have gained wide acceptance across multiple surgical disciplines to improve postoperative outcomes and to decrease hospital length of stay (LOS). However, there is limited information in the existing literature for vascular patients. We describe the implementation and early results of an ERP and barriers to its implementation for lower extremity bypass surgery. Our intention is to provide a framework to assist with implementation of similar ERPs. METHODS: Using the plan, do, check, adjust methodology, a multidisciplinary team was assembled. A database was used to collect information on patient-, procedure-, and ERP-specific metrics. We then retrospectively analyzed patients' demographics and outcomes. RESULTS: During 9 months, an ERP (n = 57) was successfully developed and implemented spanning preoperative, intraoperative, and postoperative phases. ERP and non-ERP patient demographics were statistically similar. Early successes include 97% use of fascia iliaca block and multimodal analgesia administration in 81%. Barriers included only 47% of patients achieving day of surgery mobilization and 19% receiving celecoxib preoperatively. ERP patients had decreased total and postoperative LOS compared with non-ERP patients (n = 190) with a mean (standard deviation) total LOS of 8.32 (8.4) days vs 11.14 (10.1) days (P = .056) and postoperative LOS of 6.12 (6.02) days vs 7.98 (7.52) days (P = .089). There was significant decrease in observed to expected postoperative LOS (1.28 [0.66] vs 1.82 [1.38]; P = .005). Variable and total costs for ERP patients were significantly reduced ($13,208 [$9930] vs $18,777 [$19,118; P < .01] and $29,865 [$22,110] vs $40,328 [$37,820; P = .01], respectively). CONCLUSIONS: Successful implementation of ERP for lower extremity bypass carries notable challenges but can have a significant impact on practice patterns. Further adjustment of our current protocol is anticipated, but early results are promising. Implementation of a vascular surgery ERP reduced variable and total costs and decreased total and postoperative LOS. We believe this protocol can easily be implemented at other institutions using the pathway outlined.

Association of Mental Health Disorders and Aortic Dissection.

INTRODUCTION: Mental health disorders (MHD), including substance abuse, have been associated with aortic dissection (AD). Aneurysmal degeneration in the residual untreated aorta after both open and endovascular treatment is not uncommon in AD. Thus, diligent long-term follow-up is necessary and MHD may play a role in treatment plan and surveillance. The impact of MHD on management, outcomes and follow-up after AD treatment is unknown and here we sought to evaluate these associations. METHODS: A retrospective review was performed on all patients diagnosed with Stanford Type A and B dissections from 2008 to 2018 at a tertiary referral center. MHD was defined by the Diagnostic and Statistical Manual of Mental Disorders (DSM-V). Patient demographics, procedural characteristics, and outcomes were analyzed. RESULTS: A total of 649 non-traumatic aortic dissections were identified in the study timeframe. The cohort consisted of 51% Type A (n = 334) dissection and 49% Type B (n = 315) dissection. Mental health disorders were present in 49.3% of the cohort. Notably, the timing of MHD diagnosis relative to development of AD is unknown in the majority of patients. Within the Type A population, a MHD was present in 50.6% (N = 162) of patients, of which the most common indication for MHD was the presence of antidepressant or antipsychotic medication (28.6%). In patients with Type A dissections, the presence of a MHD did not significantly affect the rate of index hospitalization intervention (68%) or long-term mortality (12.5% in patients with a MHD). Within the Type B population, a MHD was present in 49.4% (n = 158) of patients, of which the most common indication for MHD was the presence of antidepressant or antipsychotic medication (30.5%). In patients with Type B dissections, the presence of a MHD did not significantly affect the rate of index hospitalization intervention (50.3% in patients with a MHD) or long-term mortality (10.1% in patients with a MHD). The overall participation in follow-up care was not significantly decreased based on the presence of a MHD compared to those without a MHD (1.66 ± 2.16 years vs. 1.68 ± 2.20 years, P = 0.93). CONCLUSION: MHD is more prevalent in AD patients than in the general population, but demonstrating a causal relationship between MHD and development/progression of AD is challenging. Despite a high prevalence of MHD in AD patients, in-hospital mortality and follow-up compliance was similar to non-MHD patients.

Long-Term Trends in Preoperative Cardiac Evaluation and Myocardial Infarction after Elective Vascular Procedures.

BACKGROUND: Vascular surgery has seen rapid increase in the use of less invasive endovascular therapies along with advancements in cardiac perioperative optimization in the past 2 decades. However, a recent American College of Surgeons National Surgical Quality Improvement Program database study found no improvement in postoperative myocardial infarction (POMI) over a 10-year period in high-risk procedures. The national Society for Vascular Surgery Vascular Quality Initiative (VQI) registry provides a more in-depth characterization of vascular surgery procedures. Here, we sought to evaluate long-term trends in POMI using VQI registry data for patients undergoing carotid endarterectomy (CEA), thoracic endovascular aortic repair (TEVAR), endovascular aortic repair (EVAR), open abdominal aortic aneurysm repair (oAAA), suprainguinal bypass (SIB), and infrainguinal bypass (IIB). METHODS: A retrospective cohort study was performed using data on elective procedures from 2003 to 2017. Procedures were subdivided by date of operation into 3-year era consecutive groups for subanalysis (2003-05, 2006-08, 2009-11, 2012-14, and 2015-17). The incidence of POMI, preoperative risk factors (including individual patient VQI cardiac risk index (CRI)), and demographics were determined over time. RESULTS: A total of 227,837 elective procedures were identified: CEA (n = 88,805, 39.0%), TEVAR (n = 7,494, 3.3%), EVAR (n = 34,376, 15.1%), oAAA (n = 7,568, 3.3%), SIB (n = 11,354, 5.0%), and IIB (n = 34,661, 15.2%). Across all procedures, the overall rate of POMI was 1.3%. POMI rates from 2003-05 to 2015-17 for CEA decreased from 0.9% to 0.7% (P = 0.21), EVAR from 2.0% to 0.7%, P = 0.003, oAAA from 6.8% to 5.1% (P = 0.12), and IIB from 3.8% to 2.4% (P = 0.003). SIB POMI decreased from 3.06% to 2.95%, P = 0.85 from 2009 to 17. While POMI after TEVAR increased from 2.40% to 2.56% from 2009 to 17, P = 0.91. Over these same time periods, only EVAR and IIB had a reduction in CRIs (P = 0.059 and P < 0.001, respectively). CEA, EVAR, IIB, and oAAA all showed a significant (P < 0.001) increase in preoperative statin use. CONCLUSIONS: Except for TEVAR, the incidence of POMI has remained unchanged or decreased over the past 15 years in VQI registries. Patients undergoing IIB and EVAR demonstrated decreases in POMI rates that correspond with a reduction in CRIs and increased preoperative statin use. CEA and SIB had no significant change in POMI rates nor CRIs. The etiology of decreased POMI rate is uncertain, but increasing statin use, patient-specific factors, and patient selection for procedures may be important drivers of this improvement.

Prevalence and Outcomes of Endovascular Infrapopliteal Interventions for Intermittent Claudication.

BACKGROUND: Although endovascular peripheral vascular interventions (PVI) are typically limited to vessels above the knee in intermittent claudication (IC), some patients have concomitant or isolated infrapopliteal disease with IC. The benefits and risks of undergoing tibial intervention remain unclear in IC patients. The purpose of this study is to evaluate the prevalence and outcomes of infrapopliteal PVI for IC. METHODS: The Vascular Quality Initiative was queried for PVI procedures performed for IC between 2003 and 2018. Patients were divided into 3 groups: isolated femoropopliteal (FP), isolated infrapopliteal (IP), and combined above and below knee interventions (COM). Multivariable logistic regression models identified predictors of minor and major amputation, as well as freedom from reintervention. Kaplan-Meier plots estimate amputation-free survival. RESULTS: We identified 34,944 PVI procedures for IC. There were 31,110 (89.0%) FP interventions, 1,045 (3.0%) IP interventions, and 2,789 (8.0%) COM interventions. Kaplan-Meier plots of amputation-free survival revealed that patients with any IP intervention had significantly higher rates of both minor and major amputation (log rank <0.001). Freedom from reintervention at 1-year was 89.2% for the FP group, 91.3% for the IP group, and 85.3% for the COM group (P < 0.0001). In multivariable analysis, factors associated with an increased risk of major amputation included isolated IP intervention (OR 6.47, 95% CI, 6.45-6.49; P < 0.0001), COM interventions (OR 2.32, 95% CI, 2.31-2.33; P < 0.0001), dialysis dependence (OR 3.34, 95% CI, 3.33-3.35; P < 0.0001), CHF (OR 1.86, 95% CI, 1.85-1.86; P = 0.021) and, nonwhite race (OR 1.64, 95% CI, 1.63-1.64; P = 0.013). CONCLUSIONS: PVI in the infrapopliteal vessels for IC is associated with higher amputation rates. This observation may suggest the need for more careful patient selection when performing PVI in patients with IC where disease extends into the infrapopliteal level.

Effects of statin and antiplatelet therapy noncompliance and intolerance on patient outcomes following vascular surgery.

OBJECTIVE: Prior studies have evaluated the effects of statin and antiplatelet agent (APA) medications on patients with peripheral arterial disease. Although the benefits of statin and APA use are well-described, there is a paucity of research into the specific outcomes of patients who are not compliant or those who are unable to take the medication owing to intolerance. Here we examine the outcomes of patients intolerant to statin and APA and compare them with patients who are compliant or noncompliant with these therapies. METHODS: Patients treated from 2005 to 2018 in the Vascular Quality Initiative registry were included. Patients with missing data or deaths within 30 days of procedure were removed. Patients were considered noncompliant if they were previously prescribed a medication at discharge but were not taking it at 1-year follow-up or if the patient was reported to be noncompliant in the registry. Medication intolerance was defined if listed as "no, for medical reasons," and mortality data were ascertained using the Social Security Death Index, which is regularly cross-referenced to the Vascular Quality Initiative registry. RESULTS: We identified 105,628 patients who met our inclusion criteria. Statin intolerance was noted in 2.3% at discharge and 2.1% at the 1-year follow-up, with 0.7% listed as intolerant at all stages. Factors associated with increased risk of intolerance to statins included female gender (P = .001), discharge APA intolerance (P = .004), insurance status (non-U.S. insurance) (P < .001), discharge APA noncompliance (P = .019), and discharge angiotensin converting enzyme inhibitor noncompliance (P = .005). Patients who were compliant with statins showed a 91% survival at 5 years vs 87% survival in noncompliant patients and 87% in intolerant patients at 5 years (P < .001). Patients with statin intolerance have a similar survival curve as noncompliant patients across all registry cohorts. Noncompliance with statins was correlated with noncompliance with APA medications (R = 0.16, P < .001). Factors associated with increased risk of statin noncompliance included preoperative ambulatory status (requiring assistance) (P = .039), female sex (P < .001), peripheral vascular intervention (P < .001) or infrainguinal open bypass procedure surgery (P = .001), discharge status (to nursing home) (P = .006) and insurance (self-pay) (P < .001). CONCLUSIONS: Patients not taking statin and APA medications have a substantially decreased 5-year survival irrespective of the reason for not taking. Importantly, patients noted to be intolerant have a similar survival curve as noncompliant patients across all registry cohorts. Intolerant patients may benefit from attempts to alter statin dose, type (hydrophilic vs lipophilic), or from newer agents such as PCSK9 inhibitors.

Factors Associated with Amputation after Peripheral Vascular Intervention for Intermittent Claudication.

BACKGROUND: The natural history of intermittent claudication (IC) is that only 25% of patients will experience worsening of their claudication symptoms, and only approximately 1-3% will progress to major amputation. The impact of increasing use of endovascular therapies on the natural history of IC has not been well established. The purpose of this study is to evaluate the incidence and identify predictors of major and minor amputations after peripheral vascular intervention (PVI) for IC. METHODS: A retrospective cohort of patients treated for IC was derived from the national PVI Vascular Quality Initiative database evaluating both preoperative and intraoperative variables from 2003 to 2017. We examined rates of major or minor amputations after ipsilateral PVI for IC. Multivariable logistic regression models were created to identify predictors of amputation along with Kaplan-Meier (KM) plots to estimate amputation-free survival. RESULTS: We identified 11,887 PVI procedures for patients undergoing elective treatment for IC without a previous history of lower extremity PVI or bypass. Major and minor amputations occurred at a combined rate of 1.08% (n = 128). Minor amputations occurred in 0.56% (n = 67) of patients at 1 year, whereas major amputations were reported in 0.51% (n = 61) of cases. KM plots of amputation-free survival revealed that patients with preoperative ankle brachial indexes (ABIs) <0.2 or noncompressible ABIs (>1.3) had significantly higher rates of any amputation compared with subjects with ABIs between 0.20-0.49, 0.50-0.89, and 0.90-1.30 (log rank, <0.001). Multivariate analysis showed that patients with preoperative symptomatic congestive heart failure (CHF) (odds ratio [OR], 6.48; 95% confidence interval [95% CI], 2.43-17.20; P < 0.001), American Society of Anesthesiologists (ASA) class IV (OR, 9.34; 95% CI, 1.94-44.89; P = 0.005), and nonwhite race (OR, 3.32; 95% CI, 1.50-7.36; P = 0.003) had significant increase in risk of major amputation after PVI. Odds of major or minor amputation were increased when patients underwent only a tibial-level intervention (major: OR, 6.26; 95% CI, 1.50-26.10; P = 0.012 and minor: OR, 7.04; 95% CI, 1.02-8.51; P = 0.001). CONCLUSIONS: With relation to amputation, the natural history of IC does not appear to be impacted by PVI sicker patients with higher ASA or symptomatic CHF, and those with isolated tibial interventions are at higher risk for amputation, and we cannot determine if this is due to patient substrate, presentation, or the intervention itself. Importantly, there are key prognostic preoperative and intraoperative indicators that can assist the clinician with predicting patients who are at a higher risk of amputation.

Complex endovascular aneurysm repair is associated with higher perioperative mortality but not late mortality compared with infrarenal endovascular aneurysm repair among octogenarians.

OBJECTIVE: As our collective experience with complex endovascular aneurysm repair (EVAR) has grown, an increasing number of older patients are being offered endovascular repair of juxtarenal aneurysms. Outcomes after complex EVAR in this older subpopulation are not well-described. We sought to specifically evaluate clinical outcomes after complex EVAR compared with infrarenal EVAR in a cohort of octogenarians. METHODS: A single-center retrospective review was conducted using a database of consecutive patients treated with elective EVAR for abdominal aortic aneurysms (AAAs) between 2009 and 2015. Only patients 80 years of age or older were included. Patients in the complex EVAR group were treated with either snorkel/chimney or fenestrated techniques, whereas infrarenal EVAR consisted of aneurysm repair without renal or visceral involvement. Relevant demographic, anatomic, and device variables, and clinical outcomes were collected. RESULTS: There were 103 patients (68 infrarenal, 35 complex) treated within the study period with a mean follow-up of 21 months. A total of 75 branch grafts were placed (59 renal, 11 celiac, 5 superior mesenteric artery) in the complex group, with a target vessel patency of 98.2% at latest follow-up. Patients undergoing complex EVAR were more likely to be male (82.8% vs 60.2%; P = .02) and have a higher prevalence of renal insufficiency (71.4% vs 44.2%; P = .008). The 30-day mortality was significantly greater in patients treated with complex EVAR (8.6% vs 0%; P = .03). There were no differences in major adverse events (P = .795) or late reintervention (P = .232) between groups. Interestingly, sac growth of more than 10 mm was noted to be more frequent with infrarenal EVAR (17.6% vs 2.8%; P = .039). However, both type IA (5.7% infrarenal; 4.9% complex) and type II endoleaks (32.3% infrarenal; 25.7% complex) were found to be equally common in both groups. Complex EVAR was not associated with increased all-cause mortality at latest follow-up (P = .322). Multivariable Cox modeling demonstrated that AAAs greater than 75 mm in diameter (hazard ratio; 4.9; 95% confidence interval, 4.6-48.2) and renal insufficiency (hazard ratio, 3.71; 95% confidence interval, 1.17-11.6) were the only independent risk factors of late death. CONCLUSIONS: Complex EVAR is associated with greater perioperative mortality compared with infrarenal EVAR among octogenarians. However, late outcomes, including the need for reintervention and all-cause mortality, are not significantly different. Larger aneurysms and chronic kidney disease portends greater risk of late death after EVAR, regardless of AAA complexity. These patient-related factors should be considered when offering endovascular treatment to older patients.