Goodney, Philip P.

Background: There is wide variation in stress test utilization before major vascular surgery and adherence to practice guidelines is unclear. We defined rates of stress test compliance at our institution and led a quality improvement initiative to improve compliance with American Heart Association (ACC/AHA) guidelines. Methods: We implemented a stress testing order set in the electronic medical record at one tertiary hospital. We reviewed all patients who underwent elective, major vascular surgery in the 6 months before (Jan 1, 2022 – Jul 1, 2022) and 6 months after (Aug 1, 2022 – Jan 31, 2023) implementation. We studied stress test guideline compliance, changes in medical or surgical management, and major adverse cardiac events (MACE). Results: Before order set implementation, 37/122 patients (30%) underwent stress testing within the past year (29 specifically ordered preoperatively) with 66% (19/29) guideline compliance. After order set implementation, 50/173 patients (29%) underwent stress testing within the past year (41 specifically ordered preoperatively) with 80% (33/41) guideline compliance. In the pre- and postimplementation cohorts, stress testing led to a cardiovascular medication change or preoperative coronary revascularization in 24% (7/29) and 27% (11/41) of patients, and a staged surgery or less invasive anesthetic strategy in 14% (4/29) and 4.9% (2/41) of patients, respectively. All unindicated stress tests were surgeon-ordered and none led to a change in management. There was no change in MACE after order set implementation. Conclusions: Electronic medical record-based guidance of perioperative stress testing led to a slight decrease in overall stress testing and an increase in guideline-compliant testing. Our study highlights a need for improved preoperative cardiovascular risk assessment prior to major vascular surgery, which may eliminate unnecessary testing and more effectively guide perioperative decision-making.

Background: In 2014, the Affordable Care Act Medicaid Expansion (ME) increased Medicaid eligibility for adults with an income level up to 138% of the federal poverty level. In this study, we examined the impact of ME on mortality and amputation in patients with peripheral artery disease (PAD). Methods: The 100% MedPAR and Part-B Carrier files from 2011 to 2018 were queried to identify all fee-for-service Medicare beneficiaries with PAD using International Classification of Diseases codes. Our primary exposure was whether a state had adopted the ME on January 1, 2014. Our primary outcomes were the change in all-cause 1-year mortality and leg amputation. We used a state-level difference-in-differences (DID) analysis to compare the rates of the primary outcomes among patients who were in states (including the District of Columbia) who adopted ME ( n = 25) versus those who were in states that did not ( n = 26). We performed a subanalysis stratifying by sex, race, region, and dual-eligibility status. Results: Over the 8-year period, we studied 37,743,929 patients. The average unadjusted 1-year mortality decreased from 2011 to 2018 in both non-ME (9.5% to 8.7%, p < 0.001) and ME (9.1% to 8.3%, p < 0.001) states. The average unadjusted 1-year amputation rate did not improve in either the non-ME (0.86% to 0.87%, p = 0.17) or ME (0.69% to 0.69%, p = 0.65) states. Across the entire cohort, the DID model revealed that ME did not lead to a significant change in mortality ( p = 0.15) or amputation ( p = 0.34). Conclusion: Medicaid Expansion was not associated with reduced mortality or leg amputation in Medicare beneficiaries with PAD.

Objective: The objective of this study was to compare endovascular aortic aneurysm repair (EVAR) versus open aortic repair (OAR) on mortality and reintervention after ruptured infrarenal abdominal aortic aneurysm (rAAA) repair in the Vascular Quality Initiative (VQI). Background: The optimal treatment modality for rAAA remains debated, with little data on long-term comparisons. Methods: VQI rAAA repairs (2004–2018) were matched with Medicare claims (VQI-VISION). Primary outcomes were in-hospital and long-term mortality. Secondary outcome was reintervention. Inverse probability weighting was used to adjust for treatment selection, and Cox Proportional Hazards models and negative binomial regressions were used for analysis. Landmark analysis was performed among patients surviving hospital discharge. Results: Among 1885 VQI/Medicare rAAA patients, 790 underwent OAR, and 1095 underwent EVAR. Median age was 76 years; 73% were male. Inverse probability weighting produced comparable groups. In-hospital mortality was lower after EVAR versus OAR (21% vs 37%, odds ratio: 0.52, 95% CI, 0.4–0.7). One-year mortality rates were lower for EVAR versus OAR [hazard ratio (HR) 0.74, 95% CI, 0.6–0.9], but not statistically different after 1 year (HR: 0.95, 95% CI, 0.8–1.2). This implies additional benefits to EVAR in the short term. Reintervention rates were higher after EVAR than OAR at 2 and 5 years (rate ratio: 1.79 95% CI, 1.2–2.7 and rate ratio:2.03 95% CI, 1.4–3.0), but not within the first year. Reintervention was associated with higher mortality risk for both OAR (HR: 1.66 95% CI, 1.1–2.5) and EVAR (HR: 2.14 95% CI, 1.6–2.9). Long-term mortality was similar between repair types (HR: 0.99, 95% CI, 0.8–1.2). Conclusions: Within VQI/Medicare patients undergoing rAAA repair, the perioperative mortality rate favors EVAR but equalizes after 1 year. Reinterventions were more common after EVAR and were associated with higher mortality regardless of treatment.

Background: We aimed to assess the effect of surgeons’ shunting practice and shunt use on the early outcomes of carotid endarterectomy (CEA) in recently symptomatic patients. Methods: We conducted a retrospective observational study based on a multicenter national prospective database. The Vascular Quality Initiative database (2010–2019) was queried for CEAs performed within 14 days after an ipsilateral stroke or transient ischemic attack. Surgeons were gauged as routine shunters if they shunted in >95% of CEAs, otherwise were classified as selective shunters. In-hospital stroke and death rates were compared between routine and selective shunters, stratifying by type of index event (transient ischemic attack versus stroke) and timing of CEA (≤2 versus >2 days). Results: Thirteen thousand four hundred sixty-nine CEAs were performed after a transient ischemic attack (43%) or stroke (57%), 3186 (24%) by routine shunters, and 10 283 (76%) by selective shunters. Comparing routine and selective shunters, in-hospital stroke (1.9% versus 2.4%; P =0.09) and death (0.4% versus 0.5%; P =0.73) rates were similar. A lower stroke rate (1.5% versus 4.2%; P =0.02) was achieved by routine shunters for CEA performed <2 days after an ischemic stroke. Among selective shunters, a higher stroke rate occurred in case of shunt use (2.9% versus 2.3%; P <0.01), mainly due to cases presenting with stroke (3.5% versus 2.4%; P <0.01) but not transient ischemic attack (1.8% versus 1.5%; P =0.57). Awake anesthesia was adopted in 7.8% of cases by selective shunters and in 0.8% by routine shunters, without impact on the perioperative stroke rate (1.8% versus 2.3%; P =0.349). Conclusions: In this large national cohort, the overall outcomes of CEA were similar between routine and selective shunters. A lower postoperative stroke rate was achieved by routine shunters in CEA performed <2 days after an ischemic stroke. Among selective shunters, intraoperatively indicated shunting determined an increased stroke rate, likely due to intraoperative hypoperfusion. These data may guide the decision regarding timing of CEA and shunting intention in symptomatic patients.

Background: Acute aortic syndrome (AAS) includes aortic dissection (AD), intramural hematoma (IMH) and penetrating aortic ulcer (PAU) and confers high rates of aortic related events. However, the risk of cardiovascular (CV) events in this patient group is unknown. The aim of this study was to define the rates of CV events in an incident cohort of AAS patients. Methods: Medical records and death certificates of all Olmsted County, MN residents with a diagnosis of AAS from 1995-2015 were reviewed and compared to age- and sex- matched population controls. Primary outcome was non-aortic CV mortality. Secondary outcome was overall mortality and first time non-fatal CV event (myocardial infarction (MI), heart failure (HF) or stroke). Events were analyzed using Cox proportional hazards regression adjusting for comorbidities. Results: Of 133 patients with AAS (77 AD, 21 IMH, 35 PAU) 57% were male, median age was 72 (SD 14) and median follow-up was 10 years. Overall survival in AAS cases and controls was 62% versus 83% at 5 years and 44% versus 60% at 10 years (adj HR 1.8, p<.001, 95% CI 1.3-2.4). CV death occurred in 21 (29%) of 73 AAS decedents due to HF (9), MI (5), other cardiac causes (5), stroke (1) and peripheral vascular disease (1). CV-related survival at 5 and 10 years after AAS diagnosis (91% and 81%) was not significantly different from controls (95% and 86%) after adjustment for comorbidities (adj HR 1.8, p=.1, 95% CI 0.9-3.6). AAS was associated with an increased risk of any first time CV event (adj HR 2.6, p<.001, 95% CI 1.6-4.4; Figure), first time diagnosis of MI (adj HR 2.8, p<.001, 95% CI 1.7-4.7) and HF (adj HR 3.2, p<.001, 95% CI 1.6-6.2) but not stroke. When excluding acute events within 14 days of diagnosis, AAS was still associated with a significantly higher mortality (adj HR 1.6, p=.011, 95% CI 1.1-2.4) and an increased risk of any first time CV event (adj HR 2.2, p=.018, 95% CI 1.1-4.1), first time MI (adj HR 2.2, p=.012, 95% CI 1.2-4.1) and HF (adj HR 2.9, p=.006, 95% CI 1.4-6.2) but not stroke. Conclusions: AAS is associated with a higher overall mortality and an increased risk of any first time CV event, first time MI and HF that persists beyond the acute phase. These data highlight the risk of CV events among those with AAS and implicate the need for long-term cardiovascular management in these patients.

Introduction: Statin dose guidelines for PAD patients are based on coronary artery disease and stroke data. The aim of our study was to determine the effect of statin dose (based on 2013 ACC/AHA guidelines) on PAD outcomes of amputation and mortality. Methods: Patients with PAD in the Veterans Affairs database were identified from 2003-2014. The exposure was highest statin dose usage (none, low-moderate and high intensity) around diagnosis of PAD (within 1 year). The outcomes were risk of incident amputation (below knee or above knee) and mortality at 1, 3 and 5 years. The effect of statin dose on the two outcomes was also analyzed using Cox proportional hazards modeling to adjust for covariates. Results: In 208,275 patients with PAD [Males: 98.1%; Mean age: 67.4 yrs (SD 9.9)], 17,643 amputations and 99,951 deaths occurred in a median follow up of 5.2 years. Almost a quarter (27.7%) of patients were not on a statin while 30.4% were on simvastatin 80 mg (no longer recommended due to drug toxicity). The risk of incident amputation declined significantly at the high intensity statin dose as seen in Table 1. In Cox models adjusting for age, gender, race, comorbidities, cholesterol levels and creatinine, the high intensity statins were associated with lower amputation risk and mortality as compared to no statin [HR 0.67; 95% CI (0.63, 0.72) and HR 0.71; 95% CI (0.68, 0.73), respectively]. Low-moderate-dose statins also had significant but smaller reductions in risk of amputation and mortality [HR amputation 0.78 (0.75, 0.82), HR death 0.78 (0.77, 0.80)]. Conclusion: This is one of the largest population based studies to examine the effect of statins on long-term PAD outcomes and the first to explore the dose-dependent effect of statins on amputation and mortality. High intensity statins are associated with a significant reduction in limb loss and mortality in PAD patients followed by a smaller risk reduction by low-moderate intensity statins as compared to no statin therapy.

Background Aortic syndromes (ASs), including aortic dissection, intramural hematoma, and penetrating aortic ulcer, carry significant acute and long-term morbidity and mortality. However, the contemporary incidence and outcomes of AS are unknown. Methods and Results We used the Rochester Epidemiology Project record linkage system to identify all Olmsted County, MN, residents with AS (1995–2015). Diagnostic imaging, medical records, and death certificates were reviewed to confirm the diagnosis and AS subtype. Age- and sex-adjusted incidence rates were estimated using annual county-level census data. Survival for patients with AS was compared with age- and sex-matched controls using Cox regression to adjust for comorbid conditions. We identified 133 patients with AS (77, aortic dissection; 21, intramural hematoma; and 35, penetrating aortic ulcer). Average age was 71.8 years (SD=14.1), and 57% were men. The age- and sex-adjusted incidence was 7.7 per 100 000 person-years, was higher for men than women (10.2 versus 5.7 per 100 000 person-years), and increased with age. Among subtypes, the incidence of aortic dissection was highest (4.4 per 100 000 person-years), whereas the incidence of penetrating aortic ulcer and intramural hematoma was lower (2.1 and 1.2 per 100 000 person-years). Overall, the incidence of AS was stable over time ( P trend=0.33), although the incidence of penetrating aortic ulcer seemed to increase from 0.6 to 2.6 per 100 000 person-years ( P =0.008) with variability over the study interval. Patients with AS had more than twice the mortality rate at 5, 10, and 20 years when compared with population-based controls (5-, 10-, and 20-year mortality 39%, 57%, and 91% versus 18%, 41%, and 66%; overall adjusted mortality hazards ratio=2.1; P <0.001). Survival was lower than expected up to 90 days after AS diagnosis and did not differ significantly by subtype or by 5-year strata of diagnosis. Conclusions Overall, the incidence of aortic dissection and intramural hematoma has remained stable since 1995, despite the decline noted for other cardiovascular disease. AS confers increased early and long-term mortality that has not changed. These data highlight the need to improve long-term care to impact the prognosis of this patient group.

Background: Statin dose guidelines for patients with peripheral artery disease (PAD) are largely based on coronary artery disease and stroke data. The aim of this study is to determine the effect of statin intensity on PAD outcomes of amputation and mortality. Methods: Using an observational cohort study design and a validated algorithm, we identified patients with incident PAD (2003–2014) in the national Veterans Affairs data. Highest statin intensity exposure (high-intensity versus low-to-moderate–intensity versus antiplatelet therapy but no statin use) was determined within 1 year of diagnosis of PAD. Outcomes of interest were lower extremity amputations and death. The association of statin intensity with incident amputation and mortality was assessed with Kaplan-Meier plots, Cox proportional hazards modeling, propensity score–matched analysis, and sensitivity and subgroup analyses, as well, to reduce confounding. Results: In 155 647 patients with incident PAD, more than a quarter (28%) were not on statins. Use of high-intensity statins was lowest in patients with PAD only (6.4%) in comparison with comorbid coronary/carotid disease (18.4%). Incident amputation and mortality risk declined significantly with any statin use in comparison with the antiplatelet therapy–only group. In adjusted Cox models, the high-intensity statin users were associated with lower amputation risk and mortality in comparison with antiplatelet therapy–only users (hazard ratio, 0.67; 95% confidence interval, 0.61–0.74 and hazard ratio, 0.74; 95% confidence interval, 0.70–0.77, respectively). Low-to-moderate–intensity statins also had significant reductions in the risk of amputation and mortality (hazard ratio amputation, 0.81; 95% confidence interval, 0.75– 0.86; hazard ratio death, 0.83; 95% confidence interval, 0.81–0.86) in comparison with no statins (antiplatelet therapy only), but effect size was significantly weaker than the high-intensity statins ( P <0.001). The association of high-intensity statins with lower amputation and death risk remained significant and robust in propensity score–matched, sensitivity, and subgroup analyses. Conclusions: Statins, especially high-intensity formulations, are underused in patients with PAD. This is the first population-based study to show that high-intensity statin use at the time of PAD diagnosis is associated with a significant reduction in limb loss and mortality in comparison with low-to-moderate–intensity statin users, and patients treated only with antiplatelet medications but not with statins, as well.

Objective: A significant cohort of patients who have undergone carotid artery stenting (CAS) will have in-stent restenosis (ISR). The optimal management of symptomatic or severe ISR remains poorly defined. The purpose of this study was to describe the indications, treatment, and mid- to long-term outcomes of patients undergoing CAS explantation for ISR. Methods: All patients undergoing internal carotid artery stent explantation with carotid artery reconstruction at Mayo Clinic Rochester, Dartmouth-Hitchcock Medical Center, and Beth-Israel Deaconess Medical Center from 2003 to 2013 were retrospectively reviewed. Isolated common carotid artery stents were excluded. Demographics, comorbidities, indications for explantation, operative details, and perioperative and postoperative outcomes were reviewed. Results: Over the study interval, a total of 971 patients underwent carotid stenting across the 3 centers. Of these, 8 patients ultimately underwent CAS explantation with carotid artery reconstruction. Mean age was 69 years and 5 patients were male. Index stent placement was for symptomatic stenosis in 4 patients, asymptomatic restenosis after endarterectomy in 2 patients, asymptomatic high lesion in 1 patient, and asymptomatic critical stenosis in 1 patient. Indications for explantation were symptomatic ISR in 4 patients and asymptomatic severe ISR in 4 patients. Method of repair was stent explantation and patch angioplasty in 5 and en bloc carotid resection with bypass in 3 patients. There were no perioperative neurologic events or cranial nerve injuries. At a mean follow-up of 38.7 months, there were 2 late disabling ipsilateral strokes (14.4 months and 19.1 months). Conclusion: A significant cohort of patients who have undergone CAS will have ISR. Although excellent perioperative results after surgical explantation can be obtained, this patient subgroup remains at risk for late neurologic events. Appropriate patient selection and diligent long-term follow-up are mandated to obtain optimal outcomes.