Impact of head and neck radiation on long-term outcomes after carotid revascularization.

OBJECTIVE: Radiation-induced carotid artery stenosis (RICS) is a well-described phenomenon seen after head and neck cancer radiation. Previously published literature suggests that, compared with atherosclerotic disease, RICS may result in worse long-term outcomes and early restenosis. This study aims to evaluate the effect of radiation on long-term outcomes after various carotid revascularization techniques using a multi-center registry database. METHODS: Patients in the Society for Vascular Surgery (SVS) Vascular Quality Initiative (VQI) registry for carotid artery intervention (carotid endarterectomy [CEA]; transfemoral carotid artery stenting [CAS]; transcarotid artery revascularization [TCAR]), who are 65 years or older were included in the study. VQI Vascular Implant Surveillance and Interventional Outcomes Network (VISION) Medicare-linked database was used to obtain long-term procedure-specific outcomes. Primary endpoints were 3-year death, stroke, and reintervention. We performed propensity matching between patients with prior radiation and those without. Kaplan-Meier analysis and a multivariate logistic regression model were used to analyze the outcome variables. RESULTS: A total of 56,472 patients had undergone carotid revascularization (CEA, n = 48,307; TCAR, n = 4593; CAS, n = 3572), 1244 patients with prior radiation and 54,925 patients without prior radiation. The prior radiation group was more likely to be male (71.9% vs 60.3%; P < .01), to receive a stent (47.5% vs 13.5%; P < .01), and to be on P2Y12 inhibitor (55.2% vs 38.3%; P < .01). Propensity matching was performed on 1223 patients (CEA, n = 655; TCAR, n = 292; CAS, n = 287). There were no significant differences in 30-day outcomes for death, stroke, or major adverse cardiovascular events for all three procedures. The prior radiation group had higher rates of cranial nerve injury (3.7% vs 1.8%; P = .04) and 90-day readmission (23.5% vs 18.3%; P = .01) after CEA. For long-term outcomes, prior radiation significantly increased mortality risk for CEA and CAS (hazard ratio [HR], 1.77; 95% confidence interval [CI], 1.38-2.27 and HR, 1.56; 95% CI, 1.02-2.36, respectively). The 3-year risk of stroke for CEA in radiated patients was also significantly higher (HR, 1.47; 95% CI, 1.03-2.09) compared with non-radiated patients. Prior radiation did not significantly affect death and stroke in patients undergoing TCAR. Prior radiation also did not impact the rates of short and long-term reintervention after CEA, CAS, or TCAR. CONCLUSIONS: Prior head and neck radiation significantly increases the risk for mortality and stroke for CEA and the risk for mortality after CAS. Long-term outcomes for TCAR are not significantly affected by prior radiation. TCAR may be the preferred treatment modality for patients with radiation-induced carotid stenosis.

Impact of a Quality Improvement Initiative on Medical Management of Veterans With Peripheral Artery Disease.

Guideline-directed medical therapy (GDMT) for peripheral artery disease (PAD) remains severely underused. Prevention of Amputation in Veterans Everywhere (PAVE) is a screening program designed to prevent or delay major lower extremity amputation. This study aimed to determine whether diagnosis of PAD through the PAVE program improves the prescription of GDMT in veterans with asymptomatic PAD. Patients enrolled into the PAVE program from our institution from 2020 to 2021 were included. Patients with an abnormal ankle-brachial index (ABI), defined as ABI <0.9 or >1.2, were selected for further analysis. Primary outcome was adherence to GDMT, following class I and class IIa recommendations. Secondary outcomes included changes in low-density lipoprotein (LDL), blood pressure, and hemoglobin A1c (HbA1c). A total of 6,313 patients were enrolled into the PAVE program between 2020 and 2021. Of these, 211 had abnormal ABI and were included in our analysis. With enrollment into PAVE, there was significant increase in the prescription of aspirin (74.4% vs 64.9%, p = 0.044) and statins (91.5% vs 82%, p = 0.006). The overall adherence to GDMT significantly increased (56.9% vs 38.9%, p <0.001). The number of patients needed to enroll in PAVE to improve GDMT adherence is 5.6 (95% confidence interval 3.6 to 12.3). Patients enrolled into PAVE program saw significant decreases in HbA1c, with mean decrease of 0.3 (p = 0.012) and a decrease in LDL, with a mean decrease of 6.2 (p = 0.01). In conclusion, enrollment into an amputation prevention program secondarily increased adherence to GDMT, driven by increases in the prescription of statins and aspirin, with resulting decreases in HbA1c and LDL.

Women of Childbearing Age Have Higher Mortality Rates Following Inpatient Interventions for Splenic Artery Aneurysms.

BACKGROUND: Splenic artery aneurysms (SAAs) are the most common type of splanchnic aneurysms. Current guidelines recommend repair of SAAs in women of childbearing age because maternal mortality is high. The purpose of this study was to evaluate treatment modalities and outcomes following inpatient SAA repair in women. METHODS: The National Inpatient Sample database from 2012 to 2018 was queried. Patients with SAAs were identified using International Classification of Diseases (ICD) 9 and 10 codes. Childbearing age was defined as 14-49 years. The primary outcome was in-hospital mortality. RESULTS: A total of 561 patients were admitted with a diagnosis of SAA between the years of 2012 and 2018. There were 267 (47.6%) female patients and of these 103 (38.6%) were of childbearing age. The overall in-hospital mortality rate was 2.7% (n = 15). There were no differences in rates of elective admissions or type of repair (open versus endovascular) between women of childbearing age and the remainder of the cohort. However, women of childbearing age were significantly more likely to undergo a splenectomy compared to the remainder of the cohort (32.0% vs. 21.4%, P = 0.028). Women of childbearing age had higher rates of in-hospital mortality compared to the remainder of the cohort (5.8% vs. 2.0%, P = 0.040). Subset analysis of the women of childbearing age revealed that those undergoing a splenectomy versus no splenectomy (14.8% vs. 2.6%, P = 0.039) and those treated in the nonelective versus elective setting (10.5% vs. 0%, P = 0.032) had higher rates of in-hospital mortality. There was 1 patient with an ICD code associated with pregnancy and they survived. CONCLUSIONS: Women of childbearing age had higher in-hospital mortality following inpatient interventions for SAAs with all of the deaths occurring in the nonelective setting. These data support the pursuit of aggressive elective treatment of SAAs in women of childbearing age.

Predicting renal function response to renal artery stenting.

OBJECTIVE: The Cardiovascular Outcomes in Renal Atherosclerotic Lesions Trial found no benefit of renal artery stenting (RAS) over medical therapy, although it was underpowered to detect a benefit among patients with chronic kidney disease (CKD). A post hoc analysis demonstrated improved event-free survival after RAS for patients whose renal function improved by 20% or more. A significant obstacle to achieving this benefit is the inability to predict which patients' renal function will improve from RAS. The objectives of the current study were to identify predictors of renal function response to RAS. METHODS: The Veteran Affairs Corporate Data Warehouse was queried for patients who underwent RAS between 2000 and 2021. The primary outcome was improvement in renal function (estimated glomerular filtration rate [eGFR]) after stenting. Patients were categorized as responders if the eGFR at 30 days or greater after stenting increased by 20% or more compared with before stenting. All others were nonresponders. RESULTS: The study cohort included 695 patients with a median follow-up of 7.1 years (interquartile range, 3.7-11.6 years). Based on postoperative change in eGFR, 202 stented patients (29.1%) were responders, and the remainder (n = 493 [70.9%]) were nonresponders. Before RAS, responders had a significantly higher mean serum creatinine, lower mean eGFR, and higher rate of decline of preoperative GFR in the months before stenting. After stenting, responders had a 26.1% increase in eGFR, compared with before stenting (P < .0001), which remained stable during follow-up. In contrast, nonresponders had a progressive 5.5% decrease in eGFR after stenting. Logistic regression analysis identified three predictors of renal function response to stenting: (1) diabetes (odds ratio [OR], 0.64; 95% confidence interval [CI], 0.44-0.91; P = .013), (2) CKD stages 3b or 4 (OR, 1.80; 95% CI, 1.26-2.57; P = .001), and (3) rate of decline in preoperative eGFR per week before stenting (OR, 1.21; 95% CI, 1.05-1.39; P = .008). CKD stages 3b and 4 and the rate of decline in preoperative eGFR are positive predictors of renal function response to stenting, whereas diabetes is a negative predictor. CONCLUSIONS: Based on our data, patients in CKD stages 3b and 4 (eGFR 15-44 mL/min/1.73 m2) are the only subgroups with a significant probability of improved renal function after RAS. The rate of decline of preoperative eGFR over the months before stenting is a powerful discriminator of patients who are most likely to benefit from RAS. Specifically, patients with a more rapid decrease in eGFR before stenting have a significantly greater probability of improved renal function with RAS. In contrast, diabetes is a negative predictor of improved renal function, so interventionalists should be circumspect about RAS in diabetic patients.

Retrieval of renal function after renal artery stenting improves event-free survival in a subgroup analysis of the Cardiovascular Outcomes in Renal Atherosclerotic Lesions trial.

OBJECTIVE: The Cardiovascular Outcomes in Renal Atherosclerotic Lesions (CORAL) trial, a multicenter randomized controlled trial with 947 patients, concluded that there was no benefit of renal artery stenting (RAS) over medical therapy. However, patients with chronic kidney disease (CKD) were not analyzed separately in the CORAL trial. CKD is a risk factor for cardiovascular and renal morbidity. We hypothesized that improved renal function after RAS would be associated with increased long-term survival and a lower risk of cardiovascular and renal events in patients with CKD. METHODS: This post hoc analysis of the CORAL trial included 842 patients with CKD stages 2 to 4 at baseline who were randomized to optimal medical therapy alone (OMT; n = 432) or RAS plus OMT (RAS + OMT; n = 410). Patients were categorized as responders or nonresponders based on the change in the estimated glomerular filtration rate (eGFR) from baseline to last follow-up (median, 3.6 years; interquartile range, 2.6-4.6 years). Responders were defined by a 20% or greater increase in eGFR from baseline; all others were designated as nonresponders. Event-free survival was defined as freedom from death and multiple cardiovascular and renal complications. Event-free survival was analyzed using the Kaplan-Meier method and log-rank test. Multivariable Cox proportional hazards regression analysis was used to identify independent predictors of event-free survival. RESULTS: The RAS + OMT group had a higher proportion of patients with improved renal function (≥20% increase in eGFR over baseline), compared with the OMT group (25.6% vs 17.1%; P = .003). However, event-free survival was no different for the two cohorts (P = .18 by the log-rank test). Multivariable Cox proportional hazards regression analysis identified four variables that independently correlated with event-free survival for the stented cohort. Higher preoperative eGFR (hazard ratio, 0.98; 95% confidence interval [CI], 0.96-0.99; P = .002) and being a responder to stenting (hazard ratio, 0.49; 95% CI, 0.26-0.95; P = .033) increased event-free survival, whereas a history of congestive heart failure (hazard ratio, 2.52; 95% CI, 1.46-4.35; P < .001) and a higher preoperative systolic BP (hazard ratio, 1.02; 95% CI, 1.01-1.03; P = .002) decreased event-free survival. Within the stented group, 105 of 410 patients (25.6%) were responders. Event-free survival was superior for responders, compared with nonresponders (P = .009 by log-rank test). The only independent preoperative negative predictor of improved renal function after stenting was diabetes (odds ratio, 0.37; 95% CI, 0.16-0.84; P = .017), which decreased the probability of improved renal function after RAS + OMT. A subset of patients (23.4%) after RAS had worsened renal function, but OMT alone produced an equivalent incidence of worsened renal function. An increased urine albumin/creatinine ratio was an independent predictor of worsened renal function after RAS. CONCLUSIONS: CORAL participants who demonstrated improved kidney function after RAS + OMT demonstrated improved event-free survival. This finding reinforces the need for predictors of outcome to guide patient selection for RAS.

Selection criterion for endovascular aortic repair in those with chronic kidney disease.

OBJECTIVE: Endovascular aortic repair (EVAR) is the preferred method of repair for abdominal aortic aneurysms (AAAs). However, patients with advanced chronic kidney disease (CKD) are a high-risk group, and it is unknown which patients with CKD benefit from EVAR vs continued surveillance. The purpose of this study was to identify which patients with advanced CKD may benefit from EVAR. METHODS: The Vascular Quality Initiative Database was utilized to identify elective EVARs for AAAs. Patients were excluded if they underwent urgent or emergent repairs. CKD stages were categorized based on preoperative estimated glomular filtration rate (eGFR) and dialysis status. Predicted 1-year mortality of untreated AAAs was calculated by modifying a validated comorbidity score that predicts 1-year mortality (Gagne Index) without repair. The primary outcome was actual 1-year mortality, which was compared with the predicted 1-year mortality without repair. RESULTS: A total of 34,926 patient met study criteria. There were differences in Gagne Indices among the varying classes of CKD. Patients with CKD 4 and CKD 5 had the highest 1-year mortality rates, followed by CKD 3b, which was significantly higher than those with CKD 1 and CKD 2. Patients with CKD 4 had no differences between actual 1-year mortality with EVAR and predicted 1-year survival without EVAR across all AAA sizes. Those with CKD 5 had worse actual 1-year survival with EVAR than predicted 1-year survival without EVAR for AAAs <5.5 cm. Patients with CKD 5 only experienced an actual mortality benefit with EVAR compared with predicted 1-year mortality without EVAR for AAAs ≥7.0 cm. CONCLUSIONS: The current data suggest that patients with CKD 3b, 4, and 5 represent a high-risk group who may not benefit from elective EVAR utilizing traditional size criteria. Patients with CKD 4 and 5 with AAAs <5.5 cm do not benefit from elective EVAR. In patients with CKD 5, elective EVAR may need to be reserved for AAAs ≥7.0 cm unless there are other concerning anatomic characteristics.

Short-Term Outcomes After Retrograde Versus Antegrade Crossing Approaches for Femoropopliteal Occlusive Disease.

OBJECTIVE: To compare short- and mid-term outcomes of patients with femoropopliteal (FP) occlusive disease treated with a retrograde vs antegrade crossing strategy. BACKGROUND: Few studies have directly compared procedural details and outcomes after retrograde vs antegrade crossing of FP lesions. METHODS: Patients undergoing retrograde approaches to FP lesions were identified from the multicenter Excellence in Peripheral Artery Disease (XLPAD) registry between 2007 and 2015. These patients were matched 1:1 to patients treated with antegrade crossing strategies based on age, gender, comorbidities, indication for procedure, and lesion characteristics. Technical success, major adverse limb events (MALEs), and overall device cost were compared between retrograde and antegrade-only crossing. RESULTS: A total of 116 patients (58 antegrade and 58 retrograde) were included. The retrograde group had higher prevalence of coronary artery disease and presence of chronic total occlusions. The retrograde approach was associated with significantly longer procedural time (186 ± 70 minutes vs 124.4 ± 60 minutes; P<.001), but similar technical success (91.4% vs 96.6%; P=.24). There was no significant difference in perioperative morbidity. Patients treated with a retrograde approach had a lower total amputation rate (8.6% vs 22.4%; P=.04) and no difference in overall mortality (8.6% vs 5.2%; P=.47). Mean procedural costs were similar in the antegrade and retrograde groups. CONCLUSION: In patients with similar disease characteristics, a retrograde approach to FP occlusive disease was associated with longer procedural time, but improved limb salvage, without significant difference in procedural cost.

Renal Artery Aneurysms in the Inpatient Setting.

BACKGROUND: The risk of rupture of renal artery aneurysms (RAAs) remains undefined. A recent paper from the Vascular Low-Frequency Disease Consortium (VLFDC) identified only 3 ruptures in 760 patients. However, over 80% of patients in the VLFDC study were treated at large academic centers, which may not reflect the pattern of care of RAAs nationwide. Thus, the purpose of this study was to evaluate the pattern of nonelective versus elective surgery requiring inpatient admission for RAAs, including nephrectomies, and their outcomes using a national database. METHODS: The National Inpatient Sample (NIS) database from 2012 to 2018 was utilized. Patients with a primary diagnosis of RAAs were identified using ICD-9 and ICD-10 codes. Ruptured RAAs (rRAAs) were identified utilizing surrogate ICD codes. The primary outcome variables for this study were proportion of RAAs requiring non-elective surgery and in-hospital mortality. RESULTS: A total of 590 inpatient admissions for RAA were identified with 554 procedures at 467 hospitals across the country. Of the 590 inpatient admissions, 380 (64.4%) admissions were deemed nonelective. There was an increasing proportion of nonelective admissions over the study period. The overall rate of nephrectomies was 7.1% (n = 42). In-hospital mortality rate for the cohort was 1.4% (n = 8) with no differences in in-hospital mortality in the elective versus nonelective setting (1.0% vs. 1.6%; P = 0.718). In the nonelective setting, patients requiring a nephrectomy (n = 23) had significantly higher rates of in-hospital mortality compared those not requiring a nephrectomy (8.7% vs. 1.1%, P = 0.045). rRAA (n = 50) patients had significantly higher in-hospital mortality compared to the remainder of the cohort (6.0% vs. 0.9%, P = 0.024). rRAA patients were also more likely to undergo a nephrectomy compared to the remainder of the cohort (16.0% vs. 6.3%, P = 0.019). CONCLUSIONS: These data demonstrate that treatment of RAAs are primarily done in the nonelective setting with a high proportion of ruptures, which could continue to rise as the threshold for repair has decreased.

Understanding who benefits from endovascular aortic repair in those deemed unfit for open repair.

INTRODUCTION: Patients with abdominal aortic aneurysms (AAAs) who are deemed unacceptable candidates for open repair (UNFIT) pose a clinical challenge. The EVAR2 Trial randomized UNFIT patients to endovascular aortic repair (EVAR) vs no intervention from 1999 to 2003, concluding that survival was not improved by EVAR. However, outcomes after EVAR over the last 2 decades have dramatically changed. Thus, the purpose of this study was to evaluate outcomes after EVAR in UNFIT patients using more contemporary data and to determine which subsets of UNFIT patients may potentially benefit from EVAR. METHODS: The Vascular Quality Initiative database (2003-2020) was used to identify elective EVARs for AAAs. Patients were categorized as UNFIT or suitable (SUITABLE) for open repair by the operative surgeon. Predicted 1-year mortality of untreated AAAs was calculated via a modified Gagne Index adjusted for AAA size. The primary outcome for the study was 30-day mortality. Secondary outcomes included perioperative major adverse cardiac events (a composite of clinically significant arrhythmia, congestive heart failure, and myocardial infarction), length of stay, and 1-year mortality. RESULTS: A total of 31,471 patients met study criteria with 27,036 (85.9%) deemed SUITABLE and 4435 (14.1%) UNFIT. UNFIT patients were more likely to experience a perioperative major adverse cardiac event (5.1% vs 2.2%, P < .001) and had longer lengths of stay (1 day [interquartile range, 1-3 days] vs 1 day [interquartile range, 1-2 days], P < .001). The 30-day mortality was significantly higher for UNFIT patients (0.8% vs 0.4%, P < .001). UNFIT patients had worse 1-year survival compared with SUITABLE patients. However, UNFIT and SUITABLE patients had significantly improved actual 1-year mortality with EVAR compared with predicted 1-year mortality without EVAR: 9.5% vs 15.6% (P < .001) and 4.0% vs 11.7% (P < .001), respectively. The mortality benefit after EVAR in UNFIT patients was primarily restricted to those with smaller Gagne Indices and larger aneurysm diameters. Patients deemed unsuitable for open repair due to frailty or multiple reasons had significantly higher 30-day mortality rates after EVAR when compared with SUITABLE patients (1.3% vs 1.6% vs 0.4%, P < .001). Those deemed unsuitable for open repair due to frailty or multiple reasons had worse 1-year cumulative survival compared with all other UNFIT patients. CONCLUSIONS: Despite being high risk with higher perioperative morbidity and mortality, UNFIT patients have lower actual 1-year mortality with EVAR than predicted 1-year mortality without EVAR. However, this potential benefit is reserved to those with small Gagne Indices, larger AAA diameters, and lack of frailty.

A single-center experience on the management of pediatric blunt aortic injury.

OBJECTIVE: Blunt abdominal aortic injury in children is a rare clinical entity with which most vascular surgeons have minimal experience. The evidence for management recommendations is limited. We have reported a single institution's experience in the care of pediatric abdominal aortic injuries. METHODS: We performed a retrospective review of consecutive pediatric patients who had been diagnosed with blunt traumatic abdominal aortic injury at our institution from 2008 to 2019. RESULTS: A total of 16 pediatric patients (50% male) were identified. They ranged in age from 4 to 17 years. All had been involved in motor vehicle collisions and had been restrained passengers with a seatbelt in use. Five patients (31%) were hypotensive en route or on arrival. Seven patients (44%) had been transferred from another hospital. The median injury severity score was 34 (interquartile range, 19-35). The infrarenal aortic injuries were stratified using the aortic injury grading classification (five, two, seven, and two with grade 1, 2, 3, and 4, respectively). Concurrent nonaortic injuries included solid organ (63%; n = 10), hollow viscus (88%; n = 14), brain (25%; n = 4), hemothorax or pneumothorax (25%; n = 4), spine fractures (81%; n = 13), and nonspine fractures (75%; n = 12). Of the 16 patients, 9 (56%) had required aortic repair. Three had required immediate revascularization for distal ischemia. The remaining six patients (38%) had undergone delayed repair, with a median interval to repair of 52 days (range, 2-916 days). One half of the delayed repairs were performed during the index hospitalization. On repeat axial imaging, the three patients who had undergone delayed repair were found to have enlarging pseudoaneurysms or flow-limiting dissections and had subsequently undergone repair during the index hospitalization. Only one patient had undergone endovascular repair. No deaths occurred, and the median follow-up was 7 months (interquartile range, 3-28 months) for our study population. All postoperative patients demonstrated stable imaging findings without requiring further intervention. Seven patients, whose injury grades had ranged from 1 to 3, were observed. Their repeat imaging studies demonstrated either stability or resolution of their aortic injury. However, one half of the patients had been lost to follow-up after discharge or after their first postoperative clinic visit. CONCLUSIONS: Delayed aortic intervention can be safely performed for most pediatric patients with blunt abdominal aortic injuries with preserved distal perfusion to the lower extremities. This finding suggests that transfer to a tertiary center with vascular expertise is a safe and feasible management strategy. However, the progression of aortic injuries was seen as early as within 48 hours and as late as 30 months after injury, underscoring the importance of long-term surveillance. However, in our cohort, 50% of the children were lost to follow-up, highlighting the need for a more structured surveillance strategy.

Endovascular Aortic Repair in Patients of Advanced Age.

PURPOSE: Treatment decisions for the elderly with abdominal aortic aneurysms (AAAs) are challenging. With advancing age, the risk of endovascular aneurysm repair (EVAR) increases while life expectancy decreases, which may nullify the benefit of EVAR. The purpose of this study was to quantify the impact of EVAR on 1-year mortality in patients of advanced age. MATERIALS AND METHODS: The 2003-2020 Vascular Quality Initiative Database was utilized to identify patients who underwent EVAR for AAAs. Patients were included if they were 80 years of age or older. Exclusions included non-elective surgery or missing aortic diameter data. Predicted 1-year mortality of untreated AAAs was calculated based on a validated comorbidity score that predicts 1-year mortality (Gagne Index, excluding the component associated with AAAs) plus the 1-year aneurysm-related mortality without repair. The primary outcome for the study was 1-year mortality. RESULTS: A total of 11 829 patients met study criteria. The median age was 84 years [81, 86] with 9014 (76.2%) being male. Maximal AAA diameters were apportioned as follows: 39.6% were <5.5 cm, 28.6% were 5.5-5.9 cm, 21.3% were 6.0-6.9 cm, and 10.6% were ≥7.0 cm. The predicted 1-year mortality rate without EVAR was 11.9%, which was significantly higher than the actual 1-year mortality rate with EVAR (8.2%; p<0.001). The overall rate of perioperative MACE was 4.4% (n = 516). Patients with an aneurysm diameter <5.5cm had worse actual 1-year mortality rates with EVAR compared to predicted 1-year mortality rates without EVAR. In contrast, those with larger aneurysms (≥5.5cm) had better actual 1-year mortality rates with EVAR. The benefit from EVAR for those with Gagne Indices 2-5 was largely restricted to those with AAAs ≥ 7.0cm; whereas those with Gagne Indices 0-1 experience a survival benefit for AAAs larger than 5.5 cm. CONCLUSION: The current data suggest that EVAR decreases 1-year mortality rates for patients of advanced age compared to non-operative management in the elderly. However, the survival benefit is largely limited to those with Gagne Indices 0-1 with AAAs ≥ 5.5 cm and Gagne Indices 2-5 with AAAs ≥ 7.0 cm. Those of advanced age may benefit from EVAR, but realizing this benefit requires careful patient selection.

Effect of Abdominal Aortic Aneurysm Size on Mid-Term Mortality After Endovascular Repair.

BACKGROUND: Previous studies have suggested that large preoperative AAA size may impact late survival after elective EVAR. It is unclear, however, whether this association applies to patients with smaller AAA between 5.0-5.5 cm, who constitute a substantial portion of patients undergoing elective EVAR. The purpose of this study was to delineate the effect of AAA size between 5.0 and 5.5 cm on mid-term mortality after EVAR by analyzing a large national cohort, the Vascular Quality Initiative (VQI) database. METHODS: Using the Vascular Quality Initiative (VQI) national database, patients who underwent EVAR for intact AAA between 2003 and 2018 were identified and stratified based on maximal AAA diameter into 3 groups: Group 1 (4.0 cm ≤ AAA <5.0 cm); Group 2 (5.0 cm ≤ AAA < 5.5 cm); and Group 3 (AAA ≥ 5.5 cm). Cox proportional hazard model and propensity score matching method were used to estimate AAA size effect on all-cause mortality at 1, 3, and 5 years after EVAR while adjusting for potential confounders. RESULTS: The study included 32,398 patients, of whom 81% were men with a mean age of 74. The most common group who underwent EVAR was Group 2 (5.0 cm ≤ AAA < 5.5 cm). Larger AAA size was associated with male sex (75% versus 79% versus 84%, for Groups 1, 2, and 3 respectively; P < 0.0001) and with coronary artery disease (27% versus 29% versus 31%, for Groups 1, 2, and 3 respectively, P< 0.0001); but was negatively associated with active smoking (33% versus 31% versus 30%, for Groups 1, 2, and 3, respectively, P< 0.001). While 10% of the largest and smallest AAA groups (Groups 3 and 1, respectively) were symptomatic, only 5% of patients in Group 2 were symptomatic (P < 0.01). Adjusted Cox proportional hazard modeling revealed that patients in Group 2 were at significantly lower risk of 5-year mortality when compared to patients in Group 3 (HR 0.66, 95% CI 0.61-0.72, P< 0.01), while similar in risk when compared to patients in Group 1 (HR 1.11, 95% CI 0.93-1.32, P= 0.26). CONCLUSION: Our analysis found that over 40% of EVAR in the national VQI cohort were performed for AAA < 5.5 cm, with the greatest number of patients undergoing EVAR at AAA size 5.0-5.5cm. Patients with AAA size 5.0-5.5 cm had better 5-year survival outcomes than patients with AAA ≥ 5.5 cm, and similar survival to patients with small AAA between 4.0-5.0 cm.

Impact of dual antiplatelet therapy after lower extremity revascularization for chronic limb-threatening ischemia.

OBJECTIVE: The optimal antiplatelet regimen after lower extremity revascularization in patients with chronic limb-threatening ischemia (CLTI) is unknown because current recommendations are based on extrapolation of data from trials in coronary artery disease and stroke. METHODS: We identified all patients undergoing an elective lower extremity revascularization for CLTI in the Vascular Quality Initiative registry discharged on a mono antiplatelet agent (MAPT) or dual antiplatelet therapy (DAPT). RESULTS: From 2003 to 2018, 50,890 patients underwent revascularization procedures for CLTI, and were discharged on MAPT or DAPT. Of these, 33,781 patients underwent endovascular therapy (EVT), and 17,109 patients underwent open surgery (OS) procedures. The rate of major amputation at 30 days in the target limb in the EVT group was 0.3% and 0.4% in the OS group (P = .22). On Kaplan-Meier analyses, patients on MAPT at discharge had a higher risk of 1-year major amputation compared with DAPT after EVT but not after OS procedures. Patients on MAPT had lower overall survival and amputation-free survival at 30 days and 1 year compared with DAPT after both EVT and OS. At 1 year, the MAPT group was at higher risk for target lesion reintervention after EVT compared with the DAPT group (15.9% vs 13%; P = .0012). There was no significant difference in thrombosis at 1 year between the MAPT and DAPT groups either after EVT (3.9% vs 3.7%; P = .3048) or OS (3.1% vs 3.2%; P = .2893). On Cox regression analysis, DAPT was associated with improved survival but not major amputation after both EVT and OS. CONCLUSIONS: In patients with CLTI, DAPT at the time of discharge has a positive impact on amputation-free survival and overall survival after both EVT and OS as well as target lesion reintervention after EVT. DAPT was not associated with a positive impact on major amputation after either EVT or OS.

COVID-19 associated mortality and cardiovascular disease outcomes among US women veterans.

The burden of COVID-19 has been noted to be disproportionately greater in minority women, a population that is nevertheless still understudied in COVID-19 research. We conducted an observational study to examine COVID-19-associated mortality and cardiovascular disease outcomes after testing (henceforth index) among a racially diverse adult women veteran population. We assembled a retrospective cohort from a Veterans Affairs (VA) national COVID-19 shared data repository, collected between February and August 2020. A case was defined as a woman veteran who tested positive for SARS-COV-2, and a control as a woman veteran who tested negative. We used Kaplan-Meier curves and the Cox proportional hazards model to examine the distribution of time to death and the effects of baseline predictors on mortality risk. We used generalized linear models to examine 60-day cardiovascular disease outcomes. Covariates studied included age, body mass index (BMI), and active smoking status at index, and pre-existing conditions of diabetes, chronic kidney disease (CKD), chronic obstructive pulmonary disease (COPD), and a history of treatment with antiplatelet or anti-thrombotic drug at any time in the 2 years prior to the index date. Women veterans who tested positive for SARS-CoV-2 had 4 times higher mortality risk than women veterans who tested negative (Hazard Ratio 3.8, 95% Confidence Interval CI 2.92 to 4.89) but had lower risk of cardiovascular events (Odds Ratio OR 0.78, 95% CI 0.66 to 0.92) and developing new heart disease conditions within 60 days (OR 0.67, 95% CI 0.58 to 0.77). Older age, obesity (BMI > 30), and prior CVD and COPD conditions were positively associated with increased mortality in 60 days. Despite a higher infection rate among minority women veterans, there was no significant race difference in mortality, cardiovascular events, or onset of heart disease. SARS-CoV-2 infection increased short-term mortality risk among women veterans similarly across race groups. However, there was no evidence of increased cardiovascular disease incidence in 60 days. A longer follow-up of women veterans who tested positive is warranted.

Case Report of a Renal Artery Aneurysm Due to IgG4-Related Disease.

We report a 5.8 cm left renal artery aneurysm in a 71-year-old male with IgG4-related disease. To our knowledge, this is the first reported renal artery aneurysm associated with this condition. After being considered for nephrectomy, the patient underwent ex vivo left renal artery aneurysm repair to preserve renal function and remains dialysis-free at 2 years of follow-up.

Outcomes after Open Lower Extremity Revascularization in Patients with Critical Limb Ischemia.

BACKGROUND: For decades, open intervention was the treatment of choice in patients requiring lower extremity revascularization. In the endovascular era, however, open and endovascular revascularization are options. The implications of prior revascularization on the outcomes for subsequent revascularization are not known. In the present study, we evaluated 30-day outcomes after open lower extremity revascularization for critical limb ischemia (CLI) in those who had previous interventions. METHODS: The 2012-2017 open lower extremity bypass Participant User Data Files from the National Surgical Quality Improvement Program were used to identify a cohort of patients with CLI. Patients whose operation was considered emergent were excluded from the analysis. Patients were stratified on whether they had a previous open or endovascular intervention or undergoing a primary revascularization. The primary outcome measure was 30-day major adverse limb events (MALEs). Secondary outcomes included major adverse cardiac events (MACEs) and wound complications. RESULTS: A total of 12,668 patients met study criteria with 59.6% (n = 7,549) undergoing a primary open revascularization, 22.4% (n = 2,839) having a prior endovascular intervention, and 18.0% (n = 2,280) having a prior open revascularization. There were notable differences in the baseline characteristics between the 3 groups. In addition, there were differences in the reason for intervention (rest pain versus tissue loss), type of revascularization, and type of conduit used between the 3 groups. After adjustment, a prior open revascularization was significantly associated with 30-day MALE when compared with a primary revascularization (adjusted odds ratio, 1.69; 95% confidence interval, 1.47-1.94; P < 0.001) and prior endovascular intervention (adjusted odds ratio, 1.76; 95% confidence interval, 1.46-2.12; P < 0.001). There were no differences in outcomes between primary revascularization and prior endovascular patients. There were no differences between MACEs or wound complications between the 3 groups. CONCLUSIONS: A prior endovascular intervention does not seem to accrue any additional short-term risk when compared with primary revascularization, suggesting an endovascular-first approach may be a safe strategy in patients with CLI. However, a prior open intervention is significantly associated with 30-day MALE in patients undergoing redo open revascularization, which may be related to the rapid decline in patients once they have exhausted their best open revascularization option.

Failure to rescue after major abdominal surgery: The role of hospital safety net burden.

BACKGROUND: We aimed to examine whether safety-net burden is a significant predictor of failure-to-rescue (FTR) after major abdominal surgery controlling for patient and hospital characteristics, including surgical volume. METHODS: Data were extracted from the 2007-2011 Nationwide Inpatient Sample. FTR was defined as mortality among patients experiencing major postoperative complications. Differences in rates of complications, mortality, and FTR across quartiles of safety-net burden were assessed with univariate analyses. Multilevel regression models were constructed to estimate the association between FTR and safety-net burden. RESULTS: Among 238,645 patients, the incidence of perioperative complications, in-hospital mortality, and FTR were 33.7%, 4.4%, and 11.8%, respectively. All the outcomes significantly increased across the quartiles of safety-net burden. In the multilevel regression analyses, safety-net burden was a significant predictor of FTR after adjustment for patient and hospital characteristics, including hospital volume. CONCLUSION: Increasing hospital safety-net burden is associated with higher odds of FTR for major abdominal surgery.

Clinical predictors of blood pressure response after renal artery stenting.

OBJECTIVE: The Cardiovascular Outcomes in Renal Atherosclerotic Lesions (CORAL) trial, a multicenter randomized controlled trial, failed to demonstrate a benefit of renal artery stenting (RAS) over medical therapy in patients with renal artery stenosis and hypertension. However, there are patients for whom RAS is a consideration because of failure of medical therapy. Unfortunately, selection of patients for RAS is complicated by a lack of validated predictors of blood pressure (BP) response. A previous single-center study identified three preoperative markers of BP response to RAS: requirement for four or more antihypertensive medications, preoperative diastolic BP >90 mm Hg, and preoperative clonidine use. To date, these markers of outcome have not been independently validated. The aim of this study was to validate these markers using data from the CORAL trial. METHODS: All patients randomized in the CORAL trial to RAS were included. American Heart Association guidelines were used to categorize patients as BP responders or nonresponders to RAS. BP responders were defined by a postoperative BP <160/90 mm Hg with a reduced number of antihypertensive medications or a reduction in diastolic BP to <90 mm Hg with the same medications after RAS. Patients with stable or worsened BP were labeled nonresponders. Variables associated with a favorable BP response were identified by multivariable logistic regression analysis. RESULTS: There were 436 patients who underwent RAS with a median age of 70 years (interquartile range [IQR], 63-76 years). The median systolic and diastolic BPs of the stented cohort at baseline were 149 mm Hg (IQR, 132-164 mm Hg) and 78 mm Hg (IQR, 70-87 mm Hg), respectively. A positive BP response occurred in 284 of 436 (65.1%) stented patients. Multivariable logistic regression analysis identified three independent markers of a positive BP response: requirement for four or more medications (odds ratio, 5.9; P < .001), preoperative diastolic BP >90 mm Hg (odds ratio 13.9; P < .001), and preoperative clonidine use (odds ratio, 4.52; P = .008). The percentage of patients with a positive BP response increased incrementally as the number of markers per patient increased, based on the Cochran-Armitage test for trend (P < .0001). CONCLUSIONS: In patients from the CORAL trial who underwent RAS, the previously reported clinical markers of BP response were validated. A prospective trial to validate their utility as predictors of BP response to RAS is warranted.

Defining the threshold surgeon volume associated with improved patient outcomes for carotid endarterectomy.

OBJECTIVE: The outcomes for common vascular operations, such as carotid endarterectomy (CEA), are associated with surgeon volume. However, the number of operations associated with an improved stroke or death rate for CEA is not known. The objective of the current study was to define the annual surgeon volume of CEAs that is associated with a lower risk of stroke or death rate. METHODS: The Nationwide Inpatient Sample was analyzed to identify patients undergoing CEA between 2003 and 2009. Annual surgeon volume was correlated with a composite end point of in-hospital stroke or death. Mixed linear regression analyses were conducted to determine if annual surgeon volume of CEAs is independent predictor of the composite outcome. Receiver operating characteristic curves were constructed from the regression models and used to calculate the Youden Index, which defined the optimal cutoff point of annual surgeon volume of CEAs in predicting in-hospital stroke and death. This cutoff point was further assessed using Chi square analyses to determine whether incremental increases in the annual volume of CEAs were associated with a lower in-hospital stroke or death rate. RESULTS: A total of 104,918 CEA cases with surgeon identifiers were included in the analysis. The crude in-hospital stroke or death rate for CEA was 1.26 %. As expected, the stroke or death rate after CEA was higher for symptomatic patients, compared to asymptomatic patients (6.46 % vs 0.72%; P < .0001). For symptomatic patients, the relationship between surgeon volume and the composite end point was not significant (P = .435). In contrast, there was a strong relationship between surgeon volume and outcomes for asymptomatic patients undergoing CEA with a stroke/death rate of 1.66%, 0.91%, and 0.65% for low-, moderate-, and high-volume surgeons (P < .0001). Multivariate analysis identified age, African-American race, Charlson Comorbidity Index, and surgeon volume as independent predictors of stroke/death after CEA for asymptomatic carotid stenosis. For asymptomatic patients, the optimal cutoff number of CEAs to predict stroke/death rate was 19.4 CEAs per year (sensitivity = 74.9%, specificity = 72.6%, Youden index = 0.475). Analyses of outcomes at different cutoff points of surgeon volume revealed that the rate of crude complications and the adjusted probability of stroke or death was higher with case numbers less than 20 CEAs per year and lower with case numbers of 20 CEA or higher per year. Cutoff points above 20 cases were year did not yield a stroke/death rate that was significantly lower than the stroke/death rate at 20 CEAs per year, which confirmed the cutoff point of 20 CEAs per year. Only 16% of surgeons in the database achieved the threshold of 20 CEAs per year. CONCLUSIONS: Higher surgeon volume is associated with improved outcomes for CEAs performed in patients with asymptomatic carotid disease, but not for symptomatic carotid disease. For asymptomatic carotid disease, the probability of stroke or death was no longer reduced significantly at cutoff points of 20 or more CEAs per year. There are a number of other variables that may impact the clinical outcomes for CEA, so it is premature at this time to restrict privileges based on surgeon volume criteria.