Implementation of a direct-to-operating room aortic emergency transfer program: Expedited management of type A aortic dissection.

INTRODUCTION: Type A Aortic Dissection (TAAD) is a surgical emergency with a time-dependent rate of mortality. We hypothesized that a direct-to-operating room (DOR) transfer program for patients with TAAD would reduce time to intervention. METHODS: A DOR program was started at an urban tertiary care hospital in February 2020. We performed a retrospective study of adult patients undergoing treatment for TAAD before (n = 42) and after (n = 84) implementation of DOR. Expected mortality was calculated using the International Registry of Acute Aortic Dissection risk prediction model. RESULTS: Median time from acceptance of transfer from emergency physician to operating room arrival was 1.37 h (82 min) faster in DOR compared to pre-DOR (1.93 h vs 3.30 h, p < 0.001). Median time from arrival to operating room was 1.14 h (72 min) faster after DOR compared to pre-DOR (0.17 h vs 1.31 h, p < 0.001). In-hospital mortality was 16.2% in pre-DOR, with an observed-to-expected (O/E) ratio of 1.03 (p = 0.24) and 12.0% in the DOR group, with an O/E ratio of 0.59 (p < 0.001). CONCLUSION: Creation of a DOR program resulted in decreased time to intervention. This was associated with a decrease in observed-to-expected operative mortality. The transfer of patients with acute type A aortic dissection to centers with direct-to-OR programs may result in decreased time from diagnosis to surgery.

International Multi-Institutional Experience with Presentation and Management of Aortic Arch Laterality in Aberrant Subclavian Artery and Kommerell's Diverticulum.

BACKGROUND: Aberrant subclavian artery (ASA) with or without Kommerell's diverticulum (KD) is a rare anatomic aortic arch anomaly that can cause dysphagia and/or life-threatening rupture. The objective of this study is to compare outcomes of ASA/KD repair in patients with a left versus right aortic arch. METHODS: Using the Vascular Low Frequency Disease Consortium methodology, a retrospective review was performed of patients ≥18 years old with surgical treatment of ASA/KD from 2000 to 2020 at 20 institutions. RESULTS: 288 patients with ASA with or without KD were identified; 222 left-sided aortic arch (LAA), and 66 right-sided aortic arch (RAA). Mean age at repair was younger in LAA 54 vs. 58 years (P = 0.06). Patients in RAA were more likely to undergo repair due to symptoms (72.7% vs. 55.9%, P = 0.01), and more likely to present with dysphagia (57.6% vs. 39.1%, P < 0.01). The hybrid open/endovascular approach was the most common repair type in both groups. Rates of intraoperative complications, death within 30 days, return to the operating room, symptom relief and endoleaks were not significantly different. For patients with symptom status follow-up data, in LAA, 61.7% had complete relief, 34.0% had partial relief and 4.3% had no change. In RAA, 60.7% had complete relief, 34.4% had partial relief and 4.9% had no change. CONCLUSIONS: In patients with ASA/KD, RAA patients were less common than LAA, presented more frequently with dysphagia, had symptoms as an indication for intervention, and underwent treatment at a younger age. Open, endovascular and hybrid repair approaches appear equally effective, regardless of arch laterality.

High incidence of type 2 endoleak and low associated adverse events in the Vascular Quality Initiative linked to Medicare claims.

INTRODUCTION: Type 2 endoleak (T2EL) is the most common adverse finding on postoperative surveillance after endovascular aortic aneurysm repair (EVAR). A low rate of aneurysm-related mortality with T2EL has been established. However, the optimal management strategy and the efficacy of reintervention remain controversial. This study used data from the Vascular Quality Initiative linked to Medicare claims (VQI-Medicare) to evaluate T2LE in a real-world cohort. METHODS: This retrospective review of EVAR procedures in VQI-Medicare included patients undergoing their first EVAR procedure between 2015 and 2017. Patients with an endoleak other than T2EL on completion angiogram and those without VQI imaging follow-up were excluded. Patients without Medicare part A or part B enrollment at the time of the procedure or without 1-year complete Medicare follow-up data were also excluded. The exposure variable was T2EL, defined as any branch vessel flow detected within the first postoperative year. Outcomes of interest were mortality, reintervention, T2EL-related reintervention, post-EVAR imaging, and T2EL behavior including spontaneous resolution, aneurysm sac regression, and resolution after reintervention. The association of prophylactic branch vessel embolization (PBE) with T2EL resolution and aneurysm sac regression was also evaluated. RESULTS: In a final cohort of 5534 patients, 1372 (24.7%) had an identified T2EL and 4162 (75.2%) did not. The median age of patients with and without T2EL was 77 and 75 years, respectively. There were no differences in mortality, imaging, reintervention, or T2EL-related reintervention at 3 years after the procedure for patients with T2EL. The aneurysm sac diameter decreased by 4 mm (range: 9-0 mm decrease) in the total cohort. Patients with inferior mesenteric artery-based T2EL had the smallest decrease in aneurysm diameter (median 1 mm decrease compared with 1.5 mm for accessory renal artery-based T2EL, 2 mm for multiple feeding vessel-based T2EL, and 4 mm for lumbar artery-based T2EL; P < .001). Spontaneous resolution occurred in 73.7% of patients (n = 809). T2ELs with evidence of multiple feeding vessels were associated with the lowest rate of spontaneous resolution (n = 51, 54.9%), compared with those with a single identified feeding vessel of inferior mesenteric artery (n = 99, 60.0%), lumbar artery (n = 655, 77.7%), or accessory renal artery (n = 31, 79.5%) (P < .001). PBE was performed in 84 patients. Patients who underwent PBE and were without detectable T2EL after EVAR had the greatest rate of sac regression at follow-up (7 mm decrease) compared with baseline. CONCLUSIONS: T2EL after EVAR is associated with high rates of spontaneous resolution, low rates of aneurysm sac growth, and no evidence of increased early mortality or reintervention. PBE in conjunction with EVAR may be indicated in some circumstances.

Contemporary outcomes after treatment of aberrant subclavian artery and Kommerell's diverticulum.

OBJECTIVE: Aberrant subclavian artery (ASA) and Kommerell's diverticulum (KD) are rare vascular anomalies that may be associated with lifestyle-limiting and life-threatening complications. The aim of this study is to report contemporary outcomes after invasive treatment of ASA/KD using a large international dataset. METHODS: Patients who underwent treatment for ASA/KD (2000-2020) were identified through the Vascular Low Frequency Disease Consortium, a multi-institutional collaboration to investigate uncommon vascular disorders. We report the early and mid-term clinical outcomes including stroke and mortality, technical success, and other operative outcomes including reintervention rates, patency, and endoleak. RESULTS: Overall, 285 patients were identified during the study period. The mean patient age was 57 years; 47% were female and 68% presented with symptoms. A right-sided arch was present in 23%. The mean KD diameter was 47.4 mm (range, 13.0-108.0 mm). The most common indication for treatment was symptoms (59%), followed by aneurysm size (38%). The most common symptom reported was dysphagia (44%). A ruptured KD was treated in 4.2% of cases, with a mean diameter of 43.9 mm (range, 18.0-100.0 mm). An open procedure was performed in 101 cases (36%); the most common approach was ASA ligation with subclavian transposition. An endovascular or hybrid approach was performed in 184 patients (64%); the most common approach was thoracic endograft and carotid-subclavian bypass. A staged operative strategy was employed more often than single setting repair (55% vs 45%). Compared with endovascular or hybrid approach, those in the open procedure group were more likely to be younger (49 years vs 61 years; P < .0001), female (64% vs 36%; P < .0001), and symptomatic (85% vs 59%; P < .0001). Complete or partial symptomatic relief at 1 year after intervention was 82.6%. There was no association between modality of treatment and symptom relief (open 87.2% vs endovascular or hybrid approach 78.9%; P = .13). After the intervention, 11 subclavian occlusions (4.5%) occurred; 3 were successfully thrombectomized resulting in a primary and secondary patency of 95% and 96%, respectively, at a median follow-up of 39 months. Among the 33 reinterventions (12%), the majority were performed for endoleak (36%), and more reinterventions occurred in the endovascular or hybrid approach than open procedure group (15% vs 6%; P = .02). The overall survival rate was 87.3% at a median follow-up of 41 months. The 30-day stroke and death rates were 4.2% and 4.9%, respectively. Urgent or emergent presentation was independently associated with increased risk of 30-day mortality (odds ratio [OR], 19.8; 95% confidence interval [CI], 3.3-116.6), overall mortality (OR, 3.6; 95% CI, 1.2-11.2) and intraoperative complications (OR, 8.3; 95% CI, 2.8-25.1). Females had a higher risk of reintervention (OR, 2.6; 95% CI, 1.0-6.5). At an aneurysm size of 44.4 mm, receiver operator characteristic curve analysis suggested that 60% of patients would have symptoms. CONCLUSIONS: Treatment of ASA/KD can be performed safely with low rates of mortality, stroke and reintervention and high rates of symptomatic relief, regardless of the repair strategy. Symptomatic and urgent operations were associated with worse outcomes in general, and female gender was associated with a higher likelihood of reintervention. Given the worse overall outcomes when symptomatic and the inherent risk of rupture, consideration of repair at 40 mm is reasonable in most patients. ASA/KD can be repaired in asymptomatic patients with excellent outcomes and young healthy patients may be considered better candidates for open approaches versus endovascular or hybrid modalities, given the lower likelihood of reintervention and lower early mortality rate.

Management of acute aortic syndromes from initial presentation to definitive treatment.

BACKGROUND: Acute aortic syndromes comprise a spectrum of diseases including aortic dissection, intramural hematoma, and penetrating atherosclerotic ulcers. Early diagnosis, rapid intervention, and multidisciplinary team care are vital to efficiently manage time-sensitive aortic emergencies, mobilize appropriate resources, and optimize clinical outcomes. OBJECTIVE: This comprehensive review outlines the multidisciplinary team approach from initial presentation to definitive interventional treatment and post-operative care. DISCUSSION: Acute aortic syndromes can be life-threatening and require prompt diagnosis and aggressive initiation of blood pressure and pain control to prevent subsequent complications. Early time to diagnosis and intervention are associated with improved outcomes. CONCLUSIONS: A multidisciplinary team can help promptly diagnose and manage aortic syndromes.

Identifying gaps in disease knowledge among patients with peripheral artery disease.

OBJECTIVE: An individual's understanding of disease risk factors and outcomes is important for the ability to make healthy lifestyle choices and decisions about disease treatment. Peripheral artery disease (PAD) is a condition with increasing global prevalence and high risk of adverse patient outcomes. This study seeks to understand the adequacy of disease understanding in patients with PAD. METHODS: This was an observational study of patients with PAD recruited from vascular surgery outpatient clinic and PAD clinical studies at a single academic medical center over an 8-month period. A 44-item paper survey assessed demographic and socioeconomic information, knowledge of personal medical history, PAD risk factors, consequences of PAD, and health education preferences. Patients with documented presence of PAD were offered the survey. Patients unable to complete the survey or provide informed consent were not considered eligible. Disease "awareness" was defined as correct acknowledgement of the presence or absence of a disease, including PAD, in the personal medical history. "PAD knowledge score" was the percentage of correct responses to questions on general PAD risk factors and consequences. Of 126 eligible patients, 109 participated. Bivariate analysis was used to study factors associated with awareness of PAD diagnosis. Factors associated with the PAD knowledge score were studied using the Pearson correlation coefficient, two-sample t test, or one-way analysis of variance. P value < .05 was considered statistically significant. RESULTS: The mean participant age was 69.4 ± 11.0 years, and 39.4% (n = 43) were female. Most participants (78.9%; n = 86) had critical limb-threatening ischemia. Only 65.4% (n = 70) of participants were aware of a diagnosis of PAD, which was less than their awareness of related comorbidities. Factors positively associated with PAD diagnosis awareness were female sex (81.4% vs 54.7%; P = .004) and history of percutaneous leg revascularization (78.6% vs 47.9%; P = .001). Among 17 patients who had undergone major leg amputation, 35% (n = 6) were unaware of a diagnosis of PAD. PAD knowledge scores correlated positively with an awareness of PAD diagnosis (59.1% vs 48.7%; P = .02) and negatively with a history of hypertension (53.4% vs 68.1%; P = .001). Most participants (86.5%; n = 90) expressed a desire to be further educated on PAD. The most popular education topics were dietary recommendations, causes, and treatment for PAD. CONCLUSIONS: Patients with PAD have deficits in their awareness of this diagnosis and general knowledge about PAD. Future research priorities should further define these deficits and their causes in order to inform new strategies that foster information-seeking behavior and effective educational programs for PAD.

Long-term Reintervention After Endovascular Abdominal Aortic Aneurysm Repair.

OBJECTIVE: To describe the long-term reintervention rate after endovascular abdominal aortic aneurysm repair (EVR), and identify factors predicting reintervention. SUMMARY OF BACKGROUND DATA: EVR is the most common method of aneurysm repair in America, and reintervention after EVR is common. Clinical factors predicting reintervention have not been described in large datasets with long-term follow-up. METHODS: We studied patients who underwent EVR using the Vascular Quality Initiative registry linked to Medicare claims. Our primary outcome was reintervention, defined as any procedure related to the EVR after discharge from the index hospitalization. We used classification and regression tree modeling to inform a multivariable Cox-regression model predicting reintervention after EVR. RESULTS: We studied 12,911 patients treated from 2003 to 2015. Mean age was 75.5 ±â€Š7.3 years, 79.9% were male, and 89.1% of operations were elective. The 3-year reintervention rate was 15%, and the 10-year rate was 33%. Five factors predicted reintervention: operative time ≥3.0 hours, aneurysm diameter ≥6.0 cm, an iliac artery aneurysm ≥2.0 cm, emergency surgery, and a history of prior aortic surgery. Patients with no risk factors had a 3-year reintervention rate of 12%, and 10-year rate of 26% (n = 7310). Patients with multiple risk factors, such as prior aortic surgery and emergent surgery, had a 3-year reintervention rate 72%, (n = 32). Modifiable factors including EVR graft manufacturer or supra-renal fixation were not associated with reintervention (P = 0.76 and 0.79 respectively). CONCLUSIONS: All patients retain a high likelihood of reintervention after EVR, but clinical factors at the time of repair can predict those at highest risk.

Contemporary management of carotid body tumors in a Midwestern academic center.

BACKGROUND: Carotid body tumors are rare, neurogenic tumors arising from the periadventitial chemoreceptive tissue of the carotid body. The purpose of this study is to ascertain the presentation and preoperative risk factors associated with surgical resection. METHODS: A single-center retrospective review of 25 carotid body tumor resections from 2002 to 2019. Demographics, periprocedural details, and postoperative outcomes were analyzed using Stata (Stata Corporation, College Station, TX). RESULTS: Among 25 patients, 64% were women, 84% were asymptomatic, and the mean age was 49 years (range 21-79). Forty-four percent of tumors were Shamblin III. Nine patients underwent preoperative embolization but did not correlate with decreased blood loss (299 cm3 vs 205 cm3, P = .35). The 30-day death, stroke, and cranial nerve injury rates were 0%, 8%, and 32%, respectively. Cranial nerve injuries included 20% vagus, 4% hypoglossal, 4% facial, and 4% glossopharyngeal, with permanent deficits in 4% (n = 1). Mean length of stay was 3.0 days (range 1-9 days). At a mean follow-up of 12 months (range 1-63 months), there has been no recurrence. CONCLUSION: Although carotid body tumors are uncommon in the Midwest, complete surgical resection is curative of these typically hormonally inactive tumors. Preoperative embolization did not affect blood loss, and the incidence of death, stroke, and permanent cranial nerve injury rates remained very low.

Thoracic endovascular aortic repair with true-false-true lumen deployment.

Endovascular treatment of aortic dissection may be complicated by challenges to navigating the true lumen. In this report, we describe treatment of a type B dissection after open type A repair with aneurysmal degeneration, a short-segment occluded true lumen, and a distal re-entry tear near the celiac artery origin. Endovascular septal fenestration and subsequent thoracic endovascular aortic repair were used to bypass the short-segment midthoracic aortic occlusion, successfully excluding the thoracic aortic aneurysm. The patient was discharged without complications, and follow-up imaging demonstrated favorable aortic remodeling. The case demonstrates feasibility of an endovascular bypass of an intervening short-segment occluded true lumen using a thoracic endovascular aortic repair with true-false-true lumen deployment.

The Comorbidity-Polypharmacy Score is an Objective and Practical Predictor of Outcomes and Mortality after Vascular Surgery.

BACKGROUND: The comorbidity-polypharmacy score (CPPS) was developed to quantify the severity of comorbidities of patients with geriatric trauma. CPPS is the sum of the number of medications and comorbidities, and is thus objective, user-friendly, and potentially adaptable to many clinical situations. We sought to understand if CPPS associates with outcomes and mortality after common vascular surgery procedures. METHODS: This is a retrospective single-center study. A total of 466 patients who underwent carotid endarterectomy, infrainguinal bypass, percutaneous lower extremity revascularization, or endovascular abdominal aortic aneurysm repair at a single medical center were included. CPPS were classified as mild, moderate, severe, and morbid based on scores of 0-7, 8-15, 15-21, and ≥21, respectively. End points were reinterventions, 30-day readmission, and mortality. We used chi-squared tests to analyze differences in categorical variables; Kruskal-Wallis tests to analyze differences in continuous variables; Kaplan-Meier estimation and Cox proportional hazard modeling to examine survival data; and receiver operator characteristic (ROC) curve analyses to assess sensitivity and specificity. RESULTS: The mean preoperative CPPS was 14.1 ± 6.1. Higher CPPS were associated with longer hospital and postoperative length of stay (P < 0.001). Severe and morbid CPPS categories had higher rates of ICU admission, reintervention, and 30-day readmission which did not reach statistical significance after correction for multiple comparisons. CPPS was independently associated with 1- and 5-year mortality in a multivariable Cox model (hazard ratio = 2.2, 95% confidence interval: 1.3-3.3). ROC analysis revealed C-statistics of 0.81 and 0.72 for 1-year and 5-year all-cause mortality, respectively (P < 0.001). CONCLUSIONS: CPPS is a simple and pragmatic clinical tool for quantifying risk of postoperative outcomes and mortality after common vascular surgery procedures. Further investigation is needed to validate the use of CPPS in enhancing existing predictors of patient outcomes and in serving as an adjunctive tool for determining resource allocation and discharge planning in patients who underwent vascular surgery.

Predictors and Consequences of Loss to Follow-up after Vascular Surgery.

BACKGROUND: Loss to follow-up (LTF) after surgery impacts quality of care and can adversely affect short- and long-term clinical outcomes. This study identifies modifiable factors contributing to LTF after vascular surgery and the factors' effect on short- and long-term clinical outcomes. METHODS: This is a retrospective single-center cohort study of 440 consecutive adult patients who underwent carotid endarterectomy, infrainguinal bypass, percutaneous lower extremity revascularization, or endovascular aortic aneurysm repair at Northwestern Memorial Hospital between November 2011 and November 2013. Twenty-six patients who died within 9 months after surgery were excluded because of competing risks with the study end points. Demographics, medical history and medications, hospitalization and procedure-related factors, and postoperative complications were collected from the medical record. The primary end point was LTF 1 month after surgery (LTF1M), defined as lack of an in-person outpatient visit with a vascular surgeon 1 month after the index procedure. Secondary outcomes were LTF 1 year after surgery (LTF1Y), defined as lack of an in-person outpatient visit with a vascular surgeon between 9 and 22 months after discharge, and overall 5-year survival. RESULTS: Overall LTF1M and LTF1Y rates were 27.3% and 46.8%, respectively. Kaplan-Meier analysis revealed no difference in survival based on the LTF1M status (P = 0.72), but patients who were LTF1Y had significantly worse survival at 5 years (P < 0.001). Seeing a nonvascular surgeon specialist at our institution (odds ratio (OR) 0.58, 95% confidence interval (CI): 0.35-0.94, P = 0.03) and having a reintervention (OR 0.17, 95% CI: 0.08-0.37, P < 0.001) were associated with decreased LTF1Y in a multivariable model. Overall mortality was more likely with LTF1Y (hazard ratio (HR) 3.27, 95% CI: 1.86-5.76, P < 0.001) and less likely with seeing another specialist at our institution (HR 0.38, 95% CI: 0.20-0.75, P = 0.005). CONCLUSIONS: LTF rates after vascular surgery are high and associated with poor long-term outcomes. Patients who did not see a nonvascular surgeon specialist at our institution had higher rates of LTF1Y and worse overall mortality, suggesting that improved integration of care can improve LTF and survival.

Results of carotid endarterectomy in patients with contralateral internal carotid artery occlusion from the Mid-America Vascular Study Group and the Society for Vascular Surgery Vascular Quality Initiative.

OBJECTIVE: Carotid endarterectomy (CEA) is among the most commonly performed vascular procedures. Some have suggested worse outcomes with contralateral internal carotid artery (ICA) occlusion. We compared patients with and patients without contralateral ICA occlusion using the Society for Vascular Surgery Vascular Quality Initiative database. METHODS: Deidentified data were obtained from the Vascular Quality Initiative. Patients with prior ipsilateral or contralateral CEA, carotid stenting, combined CEA and coronary artery bypass graft, or <1-year follow-up were excluded, yielding 1737 patients with and 45,179 patients without contralateral ICA occlusion. Groups were compared with univariate tests, and differences identified in univariate testing were entered into multivariate models to identify independent predictors of outcomes and in particular whether contralateral ICA occlusion is an independent predictor of outcomes. RESULTS: Patients with contralateral ICA occlusion were younger and more likely to be smokers; they were more likely to have chronic obstructive pulmonary disease, preoperative neurologic symptoms (56% vs 47%), nonelective CEA (16% vs 13%), and shunt placement (75% vs 53%; all P < .001). The 30-day ipsilateral stroke risk was 1.3% with vs 0.7% without contralateral ICA occlusion (P = .004). The 30-day and 1-year survival estimates were 99.0% ± 0.5% and 94.1% ± 1.1% with vs 99.6% ± 0.1% and 96.0% ± 0.2% without contralateral ICA occlusion (log-rank, P < .001). Logistic regression analysis identified prior neurologic event (P = .046), nonelective surgery (P = .047), absence of coronary artery disease (P = .035), and preoperative angiotensin-converting enzyme inhibitor use (P = .029) to be associated with 30-day ipsilateral stroke risk, but contralateral ICA occlusion remained an independent predictor in that model (odds ratio, 2.29; P = .026). However, after adjustment for other factors (Cox proportional hazards), risk of ipsilateral stroke (including perioperative) during follow-up was not significantly greater with contralateral ICA occlusion (hazard ratio, 1.21; P = .32). Results comparing propensity score-matched cohorts mirrored those from the larger data set. CONCLUSIONS: This study demonstrates likely clinically insignificant differences in early stroke or death in comparing CEA patients with and those without contralateral ICA occlusion. After adjustment for other factors, contralateral ICA occlusion was not associated with a greater risk of ipsilateral stroke (including perioperative) in longer follow-up. Mortality was greater with contralateral ICA occlusion, and this difference was more pronounced at 1 year despite younger age of the contralateral ICA occlusion group. CEA risk remains low even in the presence of contralateral ICA occlusion and appears to be explained at least in part by other factors. CEA should still be considered appropriate in the face of contralateral ICA occlusion.

Use of a balloon-expandable sheath for transfemoral complex endovascular aortic repair.

Authors' Note: On April 30, 2019, Terumo Medical Corporation issued a voluntary product recall for and discontinued manufacturing of the SoloPath Balloon Expandable Sheath System, the device used for the procedures outlined in this article. Data collection, data analysis, and manuscript submission occurred prior to notice of this recall. The authors of this article were unaware of adverse events associated with this device and the 15 procedures reviewed for this series were free of events related to the reason for this device recall. Management of iliac artery disease remains a challenging problem in the setting of complex endovascular aortic procedures. In spite of the nonavailability of the device outlined in this article, the authors feel that the value of innovative solutions to this clinical problem (including the use of a balloon expandable sheath) merits public review of this technique and its results. Vascular access complications contribute to the morbidity of fenestrated endovascular aneurysm repair (FEVAR). As the ability to perform these procedures progresses, new techniques emerge to overcome difficult peripheral vascular anatomy and to minimize these complications. We describe our use of a balloon-expandable sheath to accommodate the multiple accesses needed for bridging stent placement during FEVAR in patients with highly calcified, tortuous, or small-diameter access vessels. We used this sheath for successful completion of FEVAR in 15 patients with challenging iliofemoral disease. There was one iliofemoral complication and no limb loss. Given the significant source of morbidity that vascular access complications contribute to endovascular procedures, we believe that a balloon-expandable sheath is a useful adjunct in FEVAR with complex iliac anatomy.

Claims-based surveillance for reintervention after endovascular aneurysm repair among non-Medicare patients.

OBJECTIVE: Many patients who undergo endovascular aortic aneurysm repair (EVR) also undergo repeat procedures, or reinterventions, to address suboptimal device performance and prevent aneurysm rupture. Quality improvement initiatives measuring reintervention after EVR has focused on fee-for-service Medicare patients. However, because patients aged less than 65 years and those with Medicare Advantage represent an important growing subgroup, we used a novel approach leveraging a state data source that captures patients of all ages and with all types of insurance. METHODS: We identified patients who underwent EVR (2011-2015) within the Vascular Quality Initiative registry and were also listed in the Statewide Planning and Research Cooperative System all-payer claims database of New York. We linked patients in the Vascular Quality Initiative to their Statewide Planning and Research Cooperative System claims file at the patient level with a 96% match rate. We compared outcomes between fee-for-service Medicare eligible, defined as age 65 or older or on dialysis, versus ineligible patients, defined as those younger than 65 and not on dialysis. Our primary outcome was reintervention. We used Cox proportional hazards regression and propensity score matching for risk adjustment. RESULTS: We studied 1285 patients with a median follow-up of 16 months (range, 1-57 months). The mean age was 74 years, 79% were male, and 84% of procedures were elective. Nearly one in six patients were not Medicare eligible (14%), and the remainder (86%) were Medicare eligible. Medicare-eligible patients were less likely to be male (77% vs 91%; P < .001), have a history of smoking (79% vs 93%; P < .001), and have a nonelective procedure (15% vs 23%; P = .013). The 3-year Kaplan-Meier rate of reintervention was 21%. We found similar rates of reintervention between Medicare-eligible patients and those who were not (19% vs 20%, log-rank P = .199; unadjusted hazard ratio [HR], 0.75; 95% confidence interval [CI], 0.49-1.16). This finding persisted in both the adjusted and propensity-matched analyses (adjusted HR, 0.82; 95% CI, 0.50-1.34; propensity-matched HR, 0.70; 95% CI, 0.36-1.37). CONCLUSIONS: Reintervention can be monitored using administrative claims from both Medicare and non-Medicare payers, and serve as an important outcome metric after EVR in patients of all ages. The rate of reintervention seems to be similar between older, Medicare-eligible individuals, and those who are not yet eligible.

Sarcopenia predicts mortality and adverse outcomes after endovascular aneurysm repair and can be used to risk stratify patients.

BACKGROUND: Endovascular aneurysm repair (EVAR) is currently the most common treatment of abdominal aortic aneurysms. Potential predictors of long-term survival after EVAR include physiologic, functional, and cognitive status, but assessments of these conditions have been difficult to standardize. Objective radiographic findings, such as skeletal muscle atrophy, or sarcopenia, may provide an additional means for selection of patients. This study investigates sarcopenia as a method to predict 1-year survival in patients undergoing EVAR. METHODS: A single-institution retrospective review was conducted of all patients who underwent elective EVAR from September 2002 to June 2014. Patients with an available periprocedural computed tomography (CT) scan and clinical data were included in the analysis. Normalized total psoas cross-sectional area (nTPA) was measured on axial CT images using the area of the bilateral psoas muscle at the third lumbar vertebral level normalized to the square of patient height. A threshold for optimal estimate of sarcopenia based on nTPA was determined using a receiver operating characteristic curve. Sarcopenia was evaluated as an independent risk predictor using univariate, multivariate, and survival analysis. RESULTS: A total of 272 EVAR-treated patients were evaluated, including 237 men and 35 women with a median age of 72 years and mean body mass index of 28.6 kg/m2. There was a significant increase in overall mortality in patients in the lowest quartile of nTPA (Q1, 23.53%; Q2, 13.24%; Q3, 7.35%; Q4, 5.88%; P = .01). The estimated nTPA threshold for increased mortality after EVAR was 500 mm2/m2. Using this threshold, sarcopenia accounted for 57% of the risk effect in our 1-year survival model. CONCLUSIONS: Sarcopenia can assist in identifying EVAR candidates who are less likely to benefit from surgery. It can be readily evaluated from preoperative CT scans and may be a useful tool in evaluation of abdominal aortic aneurysm patients with applications in risk evaluation and telemedicine.

A Novel Quality of Life Instrument for Patients with an Abdominal Aortic Aneurysm.

OBJECTIVE: The surveillance and treatment of abdominal aortic aneurysms (AAAs) may impact patient quality of life (QOL). A novel AAA specific QOL instrument was developed and validated to quantify the impact of AAA surveillance on QOL. METHODS: The study was performed in two phases: development (2011-2013) and validation (2013-2014) of a survey instrument. Content was informed by focus groups at three centres (22 patients) and two multidisciplinary physician focus groups (6 vascular surgeons, 7 primary care providers). Cognitive interviews (17 patients) ensured questions were understood as intended. The final survey was mailed to AAA patients at six US institutions. Patients were scored on two AAA specific domains of QOL: emotional impact (EIS) and behavioural change (BCS), range 0-100 with higher scores indicating worse quality of life. Test retest reliability and internal consistency were assessed. Discriminant validity was determined by comparing scores between patients under surveillance vs. those who had undergone AAA repair. Scores were externally validated by correlation with the Short Form (SF)-12. RESULTS: A total of 1,008 (73%) of 1,373 patients returned surveys: 351 (35%) were under surveillance, 657 (65%) had undergone repair (endovascular, 414; open, 179; unsure, 64). Median EIS was 11 (range 0-95; IQR 7-26). Median BCS was 13 (range 0-100; IQR 9-47). To test reliability, 337 patients repeated the survey after four weeks with no significant differences between scores over time. EIS and BCS demonstrated good internal consistency (Cronbach's Alpha 0.85 and 0.75 respectively). There was strong correlation between scores (r = 0.53) and both related moderately to SF-12 scores (r = 0.45 and r = 0.39, respectively). Patients under AAA surveillance had worse EIS than repair patients (22 vs. 13; p < .001). Patients with a higher perceived rupture risk had a worse EIS (45 vs. 12; p < .001) and BCS (30 vs. 13; p < .001). CONCLUSIONS: An AAA specific QOL instrument was successfully created and validated. The range of impact on QOL by AAA surveillance is broad. For most patients the impact is minimal, but for some, especially those with a greater perceived rupture risk, it is severe.

Using Implementation Science to Adapt a Training Program to Assist Surgeons with High-Stakes Communication.

OBJECTIVE: Surgeons often conduct difficult conversations with patients near the end of life, yet surgical education provides little formalized communication training. We developed a communication tool, Best Case/Worst Case, and trained surgeons using a one-on-one resource intensive format that was effective but difficult to scale for widespread dissemination. We aimed to generate an implementation package to teach surgeons using fewer resources without sacrificing fidelity. DESIGN, SETTING, AND PARTICIPANTS: We used the Replicating Effectiveness Programs framework to guide our implementation strategy and tested our intervention with 39 surgical residents at 4 institutions from September 2016 to June 2017. The implementation package consisted of: (1) instructional video, (2) checklist to assess competence, (3) learner manual, and (4) instructor manual. We focused on 3 implementation outcomes: feasibility, fidelity, and acceptability to participants. RESULTS: Attendance rates ranged from 16% to 75%. Site leaders had little difficulty identifying suitable instructors; however, resident recruitment proved challenging. Sixty-nine percent of residents completed the post-training assessment and the mean score was 12.8 (range 8-15) using the 15-point checklist. Across sites, 69% strongly agreed that Best Case/Worst Case is better than how they usually approach high-stakes conversations and 100% felt prepared to use the tool after training. Instructors reported that the training provided residents with the necessary skills to perform the fundamental elements of Best Case/Worst Case. CONCLUSIONS: Using implementation science we demonstrated that a resource intensive communication training intervention can be successfully modified for group-learning and wide-scale dissemination. However, we identified barriers to implementation, including challenges with feasibility and programmatic buy-in that inform not only resident education but also communication skills training more broadly.

A comparison of reintervention rates after endovascular aneurysm repair between the Vascular Quality Initiative registry, Medicare claims, and chart review.

OBJECTIVE: The accurate measurement of reintervention after endovascular aneurysm repair (EVAR) is critical during postoperative surveillance. The purpose of this study was to compare reintervention rates after EVAR from three different data sources: the Vascular Quality Initiative (VQI) alone, VQI linked to Medicare claims (VQI-Medicare), and a "gold standard" of clinical chart review supplemented with telephone interviews. METHODS: We reviewed the medical records of 729 patients who underwent EVAR at our institution between 2003 and 2013. We excluded patients without follow-up reported to the VQI (n = 68 [9%]) or without Medicare claims information (n = 114 [16%]). All patients in the final analytic cohort (n = 547) had follow-up information available from all three data sources (VQI alone, VQI linked to Medicare, and chart review). We then compared reintervention rates between the three data sources. Our primary end points were the agreement between the three data sources and the Kaplan-Meier estimated rate of reintervention at 1 year, 2 years, and 3 years after EVAR. For gold standard assessment, we supplemented chart review with telephone interview as necessary to assess reintervention. RESULTS: VQI data alone identified 12 reintervention events in the first year after EVAR. Chart review confirmed all 12 events and identified 18 additional events not captured by the VQI. VQI-Medicare data successfully identified all 30 of these events within the first year. VQI-Medicare also documented four reinterventions in this time period that did not occur on the basis of patient interview (4/547 [0.7%]). The agreement between chart review and VQI-Medicare data at 1 year was excellent (κ = 0.93). At 3 years, there were 81 (18%) reinterventions detected by VQI-Medicare and 70 (16%) detected by chart review for a sensitivity of 92%, specificity of 96%, and κ of 0.80. Kaplan-Meier survival analysis demonstrated similar reintervention rates after 3 years between VQI-Medicare and chart review (log-rank, P = .59). CONCLUSIONS: Chart review after EVAR demonstrated a 6% 1-year and 16% 3-year reintervention rate, and almost all (92%) of these events were accurately captured using VQI-Medicare data. Linking VQI data with Medicare claims allows an accurate assessment of reintervention rates after EVAR without labor-intensive physician chart review.

There Is Limited Value in the One Month Post Endovascular Aortic Aneurysm Repair Surveillance Computed Tomography Scan.

BACKGROUND: Endovascular aortic aneurysm repair (EVAR) is the preferred first-line treatment for abdominal aortic aneurysms. Current postprocedure surveillance recommendations by manufacturers are a 1-month computed tomography angiography (CTA) followed by a 12-month CTA in most circumstances. The objective of this study is to determine the utility of the 1-month CTA following elective EVAR and determine if initial surveillance at 6-month CTA is appropriate. METHODS: A single-center retrospective chart review of all elective EVARs at a tertiary medical center over a 12-year period was conducted. Patients were excluded if postoperative surveillance imaging was not available. Data analysis encompassed demographics, chart review, and imaging including angiogram and cross-sectional imaging to asses for endoleaks and other findings. RESULTS: There were 363 patients who underwent elective EVAR and had available postoperative imaging during the study period. Within the 1-month follow-up, a CTA group of 316 patients was detected with 98 (31%) endoleaks. Of these, 5 (1.5%) required intervention: 1 for infolding of an iliac limb and 4 for type I endoleak which was present on completion angiogram-3 in patients treated outside of instructions for use and 1 with a type Ib endoleak on intraoperative completion imaging. In the 158 patients with 1 and 3-month CTAs, there were 47 persistent endoleaks, 9 previously undetected endoleaks not seen in 1-month CTA, and 13 resolved endoleaks. Three patients (1.2%) underwent intervention for type II endoleak and aneurysm expansion. In 47 patients with only a 6-month CTA, there were 16 endoleaks not seen on completion angiography and 2 of which were treated with reintervention-1 for a type I endoleak and 1 for a type II endoleak. CONCLUSIONS: There is limited utility to 1-month surveillance CTA in patients undergoing elective EVAR within the device instructions for use that has no evidence of type I endoleak on completion angiography. It is safe to start routine EVAR surveillance at 6 months in this patient population. This has implications when considering bundled and value-based payments in the longitudinal care of abdominal aortic aneurysm patients.

Evidence-Based Bundled Quality Improvement Intervention for Reducing Surgical Site Infection in Lower Extremity Vascular Bypass Procedures.

BACKGROUND: Surgical site infection (SSI) poses a significant burden to patients and healthcare resources. Vascular Quality Initiative (VQI) data identify a higher rate of SSIs for lower extremity bypass than other vascular procedures. Bundled interventions have successfully reduced SSIs in other surgical procedures. STUDY DESIGN: We evaluated our institution-specific VQI data for modifiable risk factors associated with index hospitalization SSI from January 2012 through October 2015. We implemented an evidence-based lower extremity bypass operation SSI reduction bundle (ie perioperative chlorhexidine showers and transverse groin incisions) and prospectively enrolled all patients who had lower extremity bypass procedures, with a target adherence rate of 50% per bundle component. Bundle adherence and SSI events were measured from March 2016 through August 2017. We carried out a pre-post evaluation of bundle effectiveness in reducing index hospitalization SSI. RESULTS: In the pre-intervention period, 43 of 234 (18%) patients had SSI events. The only risk factors associated with SSI (ie female sex, diabetes, overweight BMI) were not readily modifiable. In an 18-month period after introduction of our intervention, adherence rates to preoperative chlorhexidine showers, a transverse incision, and a postoperative chlorhexidine shower were 71% (52 of 73), 48% (24 of 50), and 88% (64 of 73), respectively. Compliance with all applicable bundle components was 36% (26 of 73). The SSI rate post-intervention decreased from 18% to 4% (3 of 73). Intention-to-treat multivariable analysis showed a 97% SSI risk reduction with the bundle (p = 0.002). As-treated analysis identified 85% (p = 0.02) and 62% (p = 0.047) SSI risk reductions from the preoperative and postoperative chlorhexidine showers, respectively. CONCLUSIONS: In this evaluation study of the effectiveness of a quality improvement intervention, SSIs were markedly decreased after implementation of our evidence-based bundle for lower extremity vascular bypass procedures.