Inter-Rater Reliability for the Amputation Endpoint in the National Vascular Quality Initiative.

BACKGROUND: National quality reporting efforts after revascularization for peripheral artery disease (PAD) are ongoing. Validation of endpoints are necessary in national quality registries. OBJECTIVES: This study sought to examine the interrater reliability for the endpoint of major amputation at 1 year in the Vascular Quality Initiative (VQI) registry and the Medicare-linked Vascular Quality Initiative registry (VQI-VISION) against electronic health record (EHR) review. METHODS: Surgical or endovascular revascularization procedures between January 1, 2010, and December 31, 2017, in the VQI registry and VQI-VISION for 2 academic health systems were queried. Major amputation data were abstracted by trained data collectors for the VQI and derived from Current Procedural Terminology codes for VQI-VISION. Cases underwent protocolized adjudication for the endpoint of major amputation by EHR review. Paired tests were used to evaluate the sensitivity and specificity. Spearman's ρ and Cohen's κ were used to evaluate interrater reliability. RESULTS: Amputation endpoints for 1,936 revascularizations were examined. Compared with major amputation data in EHR review, the sensitivity for the VQI registry was 35.9% and the specificity was 99.4% (ρ = 0.53; κ = 0.48). For VQI-VISION, sensitivity was 67.7% and specificity was 98.9% (ρ = 0.75; κ = 0.74). For any amputation in VQI data, sensitivity was 35.3% and specificity was 99.3% (ρ = 0.53; κ = 0.46), and for VQI-VISION, they were 71.6% and 97.7%, respectively (ρ = 0.75; κ = 0.74). CONCLUSIONS: Almost two-thirds of the amputations in the VQI registry and one-third of amputations in VQI-VISION were missing at 1 year compared against adjudicated EHR review. In preparing for national reporting systems for major amputation tracking, data collection system reform is needed.

Changes in global mortality from aortic aneurysm.

OBJECTIVE: Globally, there has been a marked increase in aortic aneurysm-related deaths between 1990 and 2019. We sought to understand the underlying etiologies for this mortality trend by examining secular changes in both demographics and the prevalence of risk factors, and how these changes may vary across sociodemographic index (SDI) regions. METHODS: We queried the Global Burden of Disease Study (GBD) for aortic aneurysm deaths from 1990 to 2019 overall and by age group. We identified the percentage of aortic aneurysm deaths attributable to each risk factor identified by GBD modeling (smoking, hypertension, lead exposure, and high sodium diet) and their respective changes over time. We then analyzed aneurysm mortality by SDI region. RESULTS: The number of aortic aneurysm-related deaths have increased from 94,968 in 1990 to 172,427 in 2019, signifying an 81.6% increase, which greatly exceeds the 18.2% increase in all-cause mortality observed over the same time interval. Examination of age-specific mortality demonstrated that the number of aortic aneurysm deaths markedly correlated with advancing age. However, when considering rate of death rather than mortality count, overall age-standardized death rates decreased 18% from 2.72 per 100,000 in 1990 to 2.21 per 100,000 in 2019. Analysis of the specific risk factors associated with aneurysm death revealed that the percentage of deaths attributable to smoking decreased from 45.6% in 1990 to 34.6% in 2019, and deaths attributable to hypertension decreased from 38.7% to 34.7%. Globally, hypertension surpassed smoking as the leading risk factor. The reported rate of death was consistently greater as SDI increased, and this effect was most pronounced among low-middle and middle SDI regions (173.2% and 170.4%, respectively). CONCLUSIONS: Despite an overall increase in the number of aneurysm deaths, there was a decrease in the age-standardized death rate, demonstrating that the observed increased number of aortic aneurysm deaths between 1990 and 2019 was primarily driven by an overall increase in the age of the global population. Fortunately, it appears that the increase in overall aneurysm-related deaths has been modulated by improved risk factor modification, in particular smoking. Given the rise in aneurysm-related deaths, global expansion of vascular specialty capabilities is warranted and will serve to amplify improvements in population-based aneurysm health achieved with risk factor control.

A Retrospective Analysis of Surgical Acuity & Procedure Volume Before & During the COVID-19 Pandemic.

INTRODUCTION: In March 2020, the American College of Surgeons recommended postponing elective procedures amid the COVID-19 pandemic. We used Medicare claims to analyze changes in surgical and interventional procedure volumes from 2016 to 2021. METHODS: We studied 37 common surgical and interventional procedures using 5% Medicare claims files from January 1, 2016, through December 31, 2021. Procedures were classified according to American College of Surgeons guidelines as low, intermediate, or high acuity, and counts were analyzed per calendar year quarter (Q1-Q4), with stratification by sex and race/ethnicity. RESULTS: We observed 1,840,577 procedures and identified two periods of marked decline. In Q2 2020, overall procedure counts decreased by 32.2%, with larger declines in low (41.1%) and intermediate (30.8%) acuity procedures. High acuity procedures declined the least (18.2%). Overall volumes increased afterward but never returned to baseline. Another marked decline occurred in Q4 2021, with all acuity levels having declined to a similar extent (40.1%, 44.2%, and 46.9% for low, intermediate, and high acuity, respectively). High and intermediate acuity procedures declined more in Q4 2021 than Q2 2020 (P = 0.002). Similar patterns were observed across sex and race/ethnicity strata. CONCLUSIONS: Two major procedural volume declines occurred between 2020 and 2022 during the COVID-19 pandemic in the United States. High acuity (life or limb threatening) procedures were least affected in the first decline (Q2 2020) but not spared in second decline (Q4 2021). Future efforts should prioritize preserving high-acuity access during times of stress.

Decision aids for patients with carotid stenosis.

BACKGROUND: Shared decision-making tools have been underused by clinicians in real-world practice. Changes to the National Coverage Determination by Medicare for carotid stenting greatly expand the coverage for patients, but simultaneously require a shared decision-making interaction that involves the use of a validated tool. Accordingly, our objective was to evaluate the currently available decision aids for carotid stenosis. METHODS: We conducted a review of the literature for published work on decision aids for the treatment of carotid disease. RESULTS: Four publications met inclusion criteria. We found the format of the decision aid impacted patient comprehension and decision making, although patient characteristics also played a role in the therapeutic decisions made. Notably, none of the available decision aids included the widely adopted transcarotid artery revascularization as an option. CONCLUSIONS: Further work is needed in the development of a widespread validated decision aid instrument for patients with carotid stenosis.

Propensity-Score Matched Analysis of Three Years Survival of Trans Carotid Artery Revascularization Versus Carotid Endarterectomy in the Vascular Quality Initiative Medicare-Linked Database.

OBJECTIVE: Carotid endarterectomy (CEA) remains the gold standard procedure for carotid revascularization. Transfemoral carotid artery stenting (TFCAS) was introduced as a minimally invasive alternative procedure in patients who are at high risk for surgery. However, TFCAS was associated with an increased risk of stroke and death compared to CEA. BACKGROUND: Transcarotid artery revascularization (TCAR) has outperformed TFCAS in several prior studies and has shown similar perioperative and 1-year outcomes compared with CEA. We aimed to compare the 1-year and 3-year outcomes of TCAR versus CEA in the Vascular Quality Initiative (VQI)-Medicare-Linked [Vascular Implant Surveillance and Interventional Outcomes Network (VISION)] database. METHODS: The VISION database was queried for all patients undergoing CEA and TCAR between September 2016 to December 2019. The primary outcome was 1-year and 3-year survival. One-to-one propensity-score matching (PSM) without replacement was used to produce 2 well-matched cohorts. Kaplan-Meier estimates, and Cox regression was used for analyses. Exploratory analyses compared stroke rates using claims-based algorithms for comparison. RESULTS: A total of 43,714 patients underwent CEA and 8089 patients underwent TCAR during the study period. Patients in the TCAR cohort were older and were more likely to have severe comorbidities. PSM produced two well-matched cohorts of 7351 pairs of TCAR and CEA. In the matched cohorts, there were no differences in 1-year death [hazard ratio (HR)=1.13; 95% CI, 0.99-1.30; P =0.065]. At 3-years, TCAR was associated with slight increased risk of death (HR=1.16; 95% CI, 1.04-1.30; P =0.008). When stratifying by initial symptomatic presentation, the increased 3-year death associated with TCAR persisted only in symptomatic patients (HR=1.33; 95% CI, 1.08-1.63; P =0.008). Exploratory analyses of postoperative stroke rates using administrative sources suggested that validated measures of claims-based stroke ascertainment are necessary. CONCLUSIONS: In this large multi-institutional PSM analysis with robust Medicare-linked follow-up for survival analysis, the rate of death at 1 year was similar in TCAR and CEA regardless of symptomatic status. The slight increase in the risk of 3-year death in symptomatic patients undergoing TCAR is likely confounded by more severe comorbidities despite matching. A randomized controlled trial comparing TCAR to CEA is necessary to further determine the role of TCAR in standard-risk patients requiring carotid revascularization.

Greater Patient Travel Distance is Associated with Perioperative and One-Year Cost Increases After Complex Aortic Surgery.

BACKGROUND: With increasing regionalization of complex aortic surgery within fewer US centers, patients may face increased travel burden when accessing aortic surgery. Longer travel distances have been associated with inferior outcomes after major surgery; however, the impacts of distance on reinterventions and costs have not been described. This study aims to assess the association between patient travel distance and longer-term outcomes including costs and reinterventions after complex aortic surgery. METHODS: A retrospective review was conducted of all patients in the Vascular Implant Surveillance and Interventional Outcomes Network database undergoing complex endovascular aortic repair including internal iliac or visceral vessel involvement, complex thoracic endovascular aortic repair including Zone 0-2 proximal extent or branched devices, and complex open abdominal aortic aneurysm repair including suprarenal or higher clamp sites. Travel distance was stratified by Rural-Urban Commuting Area population-density category. Multinomial logistic regression models, negative-binomial models, and zero-inflated Poisson models were used to assess the association between travel distance and index procedural and comprehensive first-year costs, long-term imaging, and long-term reinterventions, respectively. RESULTS: Between 2011 and 2018, 8,782 patients underwent complex aortic surgery in the Vascular Implant Surveillance and Interventional Outcomes Network database, including 4,822 complex endovascular aortic repairs, 2,672 complex thoracic endovascular aortic repairs, and 1,288 complex open abdominal aortic aneurysm repairs. Median travel distance was 22.8 miles (interquartile range 8.6-54.8 miles, range 0-2,688.9 miles). Median age was 75 years for all distance quintiles. Patients traveling farther were more likely to be female (26.8% in quintile 5 [Q5] vs. 19.9% in Q1, P < 0.001) and to have had a prior aortic surgery (20.8% for Q5 vs. 5.9% for Q1, P < 0.001). Patients traveling farther had higher index procedural costs, with adjusted odds ratio (OR) 2.34 (95% confidence interval [CI] 1.86-2.94, P < 0.0001) of being in the highest cost tertile versus lowest for patients in Q5 vs. Q1. For patients with ≥ 1-year follow-up, those traveling farther had higher imaging costs, with adjusted Q5 OR 1.55 (95% CI 1.22-1.95, P = 0.0002), and comprehensive first-year costs, with adjusted Q5 OR 2.06 (95% CI 1.57-2.70, P < 0.0001). In contrast, patients traveling farther had similar numbers of reinterventions and imaging studies postoperatively. CONCLUSIONS: Patients traveling farther for complex aortic surgery have higher procedural costs, postoperative imaging costs, and comprehensive first-year costs. These patients should be targeted for increased care coordination for improved outcomes and healthcare system burden.

The financial burden associated with endovascular repair of thoracoabdominal and pararenal aortic aneurysms using physician-modified fenestrated-branched endografts.

OBJECTIVE/BACKGROUND: Endovascular thoracoabdominal and pararenal aortic aneurysm repair is more complex and requires more devices than infrarenal aneurysm repair. It is unclear if current reimbursement covers the cost of delivering this more advanced form of vascular care. The objective of this study was to evaluate the economics of fenestrated-branched (FB-EVAR) physician-modified endograft (PMEG) repairs. METHODS: We obtained technical and professional cost and revenue data for four consecutive fiscal years (July 1, 2017, to June 30, 2021) at our quaternary referral institution. Inclusion criteria were patients who underwent PMEG FB-EVAR in a uniform fashion by a single surgeon for thoracoabdominal/pararenal aortic aneurysms. Patients in industry-sponsored clinical trials or receiving Cook Zenith Fenestrated grafts were excluded. Financial data were analyzed for the index operation. Technical costs were divided into direct costs that included devices and billable supplies and indirect costs including overhead. RESULTS: 62 patients (79% male, mean age: 74 years, 66% thoracoabdominal aneurysms) met inclusion criteria. The mean aneurysm size was 6.0 cm, the mean total operating time was 219 minutes, and the median hospital length of stay was 2 days. PMEGs were created with a mean number of 3.7 fenestrations, using a mean of 8.6 implantable devices per case. The average technical cost per case was $71,198, and the average technical reimbursement was $57,642, providing a net negative technical margin of $13,556 per case. Of this cohort, 31 patients (50%) were insured by Medicare remunerated under diagnosis-related group code 268/269. Their respective average technical reimbursement was $41,293, with a mean negative margin of $22,989 per case, with similar findings for professional costs. The primary driver of technical cost was implantable devices, accounting for 77% of total technical cost per case over the study period. The total operating margin, including technical and professional cost and revenue, for the cohort during the study period was negative $1,560,422. CONCLUSIONS: PMEG FB-EVAR for pararenal/thoracoabdominal aortic aneurysms produces a substantially negative operating margin for the index operation driven largely by device costs. Device cost alone already exceeds total technical revenue and presents an opportunity for cost reduction. In addition, increased reimbursement for FB-EVAR, especially among Medicare beneficiaries, will be important to facilitate patient access to such innovative technology.

Trends of Concomitant Diabetes and Peripheral Artery Disease and Lower Extremity Amputation in US Medicare Patients, 2007 to 2019.

BACKGROUND: Previous studies demonstrate geographic and racial/ethnic variation in diagnosis and complications of diabetes and peripheral artery disease (PAD). However, recent trends for patients diagnosed with both PAD and diabetes are lacking. We assessed the period prevalence of concurrent diabetes and PAD across the United States from 2007 to 2019 and regional and racial/ethnic variation in amputations among Medicare patients. METHODS: Using Medicare claims from 2007 to 2019, we identified patients with both diabetes and PAD. We calculated period prevalence of concomitant diabetes and PAD and incident cases of diabetes and PAD for every year. Patients were followed to identify amputations, and results were stratified by race/ethnicity and hospital referral region. RESULTS: 9 410 785 patients with diabetes and PAD were identified (mean age, 72.8 [SD, 10.94] years; 58.6% women, 74.7% White, 13.2% Black, 7.3% Hispanic, 2.8% Asian/API, and 0.6% Native American). Period prevalence of diabetes and PAD was 23 per 1000 beneficiaries. We observed a 33% relative decrease in annual new diagnoses throughout the study. All racial/ethnic groups experienced a similar decline in new diagnoses. Black and Hispanic patients had on average a 50% greater rate of disease compared with White patients. One- and 5-year amputation rates remained stable at ≈1.5% and 3%, respectively. Native American, Black, and Hispanic patients were at greater risk of amputation compared with White patients at 1- and 5-year time points (5-year rate ratio range, 1.22-3.17). Across US regions, we observed differential amputation rates, with an inverse relationship between the prevalence of concomitant diabetes and PAD and overall amputation rates. CONCLUSIONS: Significant regional and racial/ethnic variation exists in the incidence of concomitant diabetes and PAD among Medicare patients. Black patients in areas with the lowest rates of PAD and diabetes are at disproportionally higher risk for amputation. Furthermore, areas with higher prevalence of PAD and diabetes have the lowest rates of amputation.

Long-term Mortality and Reintervention After Repair of Ruptured Abdominal Aortic Aneurysms Using VQI-matched Medicare Claims.

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.

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.

Association between sex and long-term outcomes of endovascular treatment for peripheral artery disease.

BACKGROUND: Endovascular peripheral vascular intervention (PVI) has become the primary revascularization technique used for peripheral artery disease (PAD). Yet, there is limited understanding of long-term outcomes of PVI among women versus men. In this study, our objective was to investigate sex differences in the long-term outcomes of patients undergoing PVI. METHODS: We performed a cohort study of patients undergoing PVI for PAD from January 1, 2010 to September 30, 2015 using data in the Vascular Quality Initiative (VQI) registry. Patients were linked to fee-for-service Medicare claims to identify late outcomes including major amputation, reintervention, major adverse limb event (major amputation or reintervention [MALE]), and mortality. Sex differences in outcomes were evaluated using cumulative incidence curves, Gray's test, and mixed effects Cox proportional hazards regression accounting for patient and lesion characteristics using inverse probability weighted estimates. RESULTS: In this cohort of 15,437 patients, 44% (n = 6731) were women. Women were less likely to present with claudication than men (45% vs. 49%, p < 0.001, absolute standardized difference, d = 0.08) or be able to ambulate independently (ambulatory: 70% vs. 76%, p < 0.001, d = 0.14). There were no major sex differences in lesion characteristics, except for an increased frequency of tibial artery treatment in men (23% vs. 18% in women, p < 0.001, d = 0.12). Among patients with claudication, women had a higher risk-adjusted rate of major amputation (hazard ratio [HR] = 1.72, 95% confidence interval [CI]: 1.18-2.49), but a lower risk of mortality (HR = 0.86, 95% CI: 0.75-0.99). There were no sex differences in reintervention or MALE for patients with claudication. However, among patients with chronic limb-threatening ischemia, women had a lower risk-adjusted hazard of major amputation (HR = 0.79, 95% CI: 0.67-0.93), MALE (HR = 0.86, 95% CI: 0.78-0.96), and mortality (HR = 0.86, 95% CI: 0.79-0.94). CONCLUSION: There is significant heterogeneity in PVI outcomes among men and women, especially after stratifying by symptom severity. A lower overall mortality in women with claudication was accompanied by a higher risk of major amputation. Men with chronic limb-threatening ischemia had a higher risk of major amputation, MALE, and mortality. Developing sex-specific approaches to PVI that prioritizes limb outcomes in women can improve the quality of vascular care for men and women.

Operative and long-term outcomes of combined and staged carotid endarterectomy and coronary bypass.

OBJECTIVE: Optimal temporal surgical management of significant carotid stenosis and coronary artery disease remains unknown. Carotid endarterectomy (CEA) and coronary artery bypass (CABG) are performed concurrently (CCAB) or in a staged (CEA-CABG or CABG-CEA) approach. Using the Vascular Quality Initiative-Vascular Implant Surveillance and Interventional Outcomes Coordinated Registry Network-Medicare-linked dataset, this study compared operative and long-term outcomes after CCAB and staged approaches. METHODS: The Vascular Quality Initiative-Vascular Implant Surveillance and Interventional Outcomes Coordinated Registry Network dataset was used to identify CEAs from 2011 to 2018 with combined CABG or CABG within 45 days preceding or after CEA. Patients were stratified based on concurrent or staged approach. Primary outcomes were stroke, myocardial infarction (MI), all-cause mortality, stroke and death as composite (SD) and all as composite within 30 days from the last procedure as well as in the long term. Univariate analysis and risk-adjusted analysis using inverse propensity weighting were performed. Kaplan-Meier curves of stroke, MI, and death were created and compared. RESULTS: There were 1058 patients included: 643 CCAB and 415 staged (309 CEA-CABG and 106 CABG-CEA). Compared with staged patients, those undergoing CCAB had a higher preoperative rate of congestive heart failure (24.8% vs 18.4%; P = .01) and decreased renal function (14.9% vs 8.5%; P < .01), as well as fewer prior neurological events (23.5% vs 31.4%; P < .01). Patients undergoing CCAB had similar weighted rate of 30-day stroke (4.6% vs 4.1%; P = .72), death (7.0% vs 5.0%; P = .32), and composite outcomes (stroke and death, 9.8% vs 8.5%; P = .56; stroke, death, and MI, 14.7% vs 17.4%; P = .31), but a lower weighted rate of MI (5.5% vs 11.5%; P < .01) vs the staged cohort. Long-term adjusted risks of stroke (hazard ratio [HR], 0.85; 95% confidence interval [CI], 0.54-1.36; P = .51) and mortality (HR, 1.02; 95% CI, 0.76-1.36; P=.91) were similar between groups, but higher risk of MI long-term was seen in those staged (HR, 1.49; 95% CI, 1.07-2.08; P = .02). CONCLUSIONS: In patients undergoing CCAB or staged open revascularization for carotid stenosis and coronary artery disease, the staged approach had an increased risk of postoperative cardiac event, but the short- and long-term rates of stroke and mortality seem to be comparable. Adverse cardiovascular event risk is high between operations when staged and should be a consideration when selecting an approach. Although factors leading to staged sequencing performance need further clarity, CCAB seems to be safe and should be considered an equally reasonable option.

The global burden of peripheral artery disease.

BACKGROUND: Previous efforts to characterize the burden of peripheral artery disease (PAD) have focused on national populations. A need for a more detailed analysis of how PAD impacts the global population has been identified. Our objective was to study in greater detail the global burden of PAD, including its impact on mortality, over the past three decades. METHODS: Using data and models from the Global Burden of Diseases, Injuries and Risk Factors Study, we estimated the prevalence, years of life lost, years lived with disability and disability-adjusted life-years (a measure accounting for incurred morbidity and mortality), attributable to PAD. We analyzed results over time and stratified by sex, age, and sociodemographic index (SDI) group. We compared PAD with other atherosclerosis-related conditions and assessed the contribution of risk factors to PAD disability-adjusted life-years. RESULTS: We observed a 72% increase in the global prevalence of PAD from an estimated 65,764,499 persons in 1990 to 113,443,016 in 2019. Prevalence per 100,000 persons increased 13% and the prevalence per 100,000 age-standardized decreased 22%. Similar patterns were seen for years of live lost, mortality, years lived with disability, and disability-adjusted life-years. The prevalence and disability were higher among women, whereas mortality and years of life lost were higher among men. Disease burden increased with increasing SDI. These increases in PAD were in contrast with global trends for the overall burden of ischemic heart disease and ischemic stroke, which had decreasing prevalence and disease-related mortality over the same time frame. Overall, only approximately 55% of PAD disease burden could be attributed to identified risk factors, with tobacco use, diabetes, and hypertension being the three major contributors in all SDI groups. CONCLUSIONS: The global prevalence and mortality associated with PAD has increased substantially, in contrast with other forms of ischemic cardiovascular disease. Globally, there is a growing need for vascular surgical resources to manage PAD, as well as public health efforts to address risk factors for this increasing health threat.

Using the Evaluating Devices Using Claims and RegisTry Data (EDUCATe) Plan within the Vascular Implant Surveillance and Interventional Outcomes Network (VISION) to Analyze the Long-Term Outcomes following Endovascular Aortic Aneurysm Repair.

BACKGROUND: Implanted devices undergo clinical trials to assess their safety and effectiveness. However, pivotal device trials are limited in their follow-up while postmarket surveillance may incompletely capture late failure. Linking clinical trials to Medicare claims can address these limitations. This study matched patients from investigational device exemption (IDE) clinical trials for endovascular aortic aneurysm repair (EVAR) to Medicare claims-based registry data to compare long-term device outcomes between the 2 sources. METHODS: Patient-level data from 2 industry-sponsored IDE trials of EVAR devices was provided by a single industry partner. Trial data were matched at the patient level to data from the Vascular Implant Surveillance and Interventional Outcomes Network (VISION), a registry that is a part of the Society for Vascular Surgery Patient Safety Organization. The primary outcomes analyzed were survival and freedom from aneurysm-related reintervention. RESULTS: Of 159 clinical trial patients, 134 were eligible for claims-based matching and 115 (85.5%) were successfully matched to VISION registry data. For the matched cohort, the Kaplan-Meier estimated survival was 94.8% at 1 year, 82.6% at 3 years, and 68.1% at 5 years. Estimates for freedom from reintervention were 90% at 1 year, 82.4% at 3 years, and 78.1% at 5 years. The estimates for survival were nearly identical between the clinical trial data and that found in the VISION data (log-rank P = 0.89). Freedom from reintervention was similar between the groups, with IDE trial reported freedom from reintervention of 87.3% and 73.3%, compared to VISION of 92.6% and 83% at 1 and 5 years, respectively (log-rank P = 0.13). CONCLUSIONS: Clinical trial patients who undergo EVAR can be successfully matched to claims-based registry data to improve long-term device surveillance and outcomes reporting. Claims-based results agreed well with IDE trial results for patients through 5 years, supporting the accuracy of claims-based data for longer-term surveillance. Linking clinical trial and claims-based registry data can lead to robust device monitoring.

Using a cohort study of diabetes and peripheral artery disease to compare logistic regression and machine learning via random forest modeling.

BACKGROUND: This study illustrates the use of logistic regression and machine learning methods, specifically random forest models, in health services research by analyzing outcomes for a cohort of patients with concomitant peripheral artery disease and diabetes mellitus. METHODS: Cohort study using fee-for-service Medicare beneficiaries in 2015 who were newly diagnosed with peripheral artery disease and diabetes mellitus. Exposure variables include whether patients received preventive measures in the 6 months following their index date: HbA1c test, foot exam, or vascular imaging study. Outcomes include any reintervention, lower extremity amputation, and death. We fit both logistic regression models as well as random forest models. RESULTS: There were 88,898 fee-for-service Medicare beneficiaries diagnosed with peripheral artery disease and diabetes mellitus in our cohort. The rate of preventative treatments in the first six months following diagnosis were 52% (n = 45,971) with foot exams, 43% (n = 38,393) had vascular imaging, and 50% (n = 44,181) had an HbA1c test. The directionality of the influence for all covariates considered matched those results found with the random forest and logistic regression models. The most predictive covariate in each approach differs as determined by the t-statistics from logistic regression and variable importance (VI) in the random forest model. For amputation we see age 85 + (t = 53.17) urban-residing (VI = 83.42), and for death (t = 65.84, VI = 88.76) and reintervention (t = 34.40, VI = 81.22) both models indicate age is most predictive. CONCLUSIONS: The use of random forest models to analyze data and provide predictions for patients holds great potential in identifying modifiable patient-level and health-system factors and cohorts for increased surveillance and intervention to improve outcomes for patients. Random forests are incredibly high performing models with difficult interpretation most ideally suited for times when accurate prediction is most desirable and can be used in tandem with more common approaches to provide a more thorough analysis of observational data.

Use of linked registry claims data for long term surveillance of devices after endovascular abdominal aortic aneurysm repair: observational surveillance study.

OBJECTIVE: To evaluate long term outcomes (reintervention and late rupture of abdominal aortic aneurysm) of aortic endografts in real world practice using linked registry claims data. DESIGN: Observational surveillance study. SETTING: 282 centers in the Vascular Quality Initiative Registry linked to United States Medicare claims (2003-18). PARTICIPANTS: 20 489 patients treated with four device types used for endovascular abdominal aortic aneurysm repair (EVAR): 40.6% (n=8310) received the Excluder (Gore), 32.2% (n=6606) the Endurant (Medtronic), 16.0% (n=3281) the Zenith (Cook Medical), and 11.2% (n=2292) the AFX (Endologix). Given modifications to AFX in late 2014, patients who received the AFX device were categorized into two groups: the early AFX group (n=942) and late AFX group (n=1350) and compared with patients who received the other devices, using propensity matched Cox models. MAIN OUTCOME MEASURES: Reintervention and rupture of abdominal aortic aneurysm post-EVAR; all patients (100%) had complete follow-up via the registry or claims based outcome assessment, or both. RESULTS: Median age was 76 years (interquartile range (IQR) 70-82 years), 80.0% (16 386/20 489) of patients were men, and median follow-up was 2.3 years (IQR 0.9-4.1 years). Crude five year reintervention rates were significantly higher for patients who received the early AFX device compared with the other devices: 14.9% (95% confidence interval 13.7% to 16.2%) for Excluder, 19.5% (18.1% to 21.1%) for Endurant, 16.7% (15.0% to 18.6%) for Zenith, and early 27.0% (23.7% to 30.6%) for the early AFX. The risk of reintervention for patients who received the early AFX device was higher compared with the other devices in propensity matched Cox models (hazard ratio 1.61, 95% confidence interval 1.29 to 2.02) and analyses using a surgeon level instrumental variable of >33% AFX grafts used in their practice (1.75, 1.19 to 2.59). The linked registry claims surveillance data identified the increased risk of reintervention with the early AFX device as early as mid-2013, well before the first regulatory warnings were issued in the US in 2017. CONCLUSIONS: The linked registry claims surveillance data identified a device specific risk in long term reintervention after EVAR of abdominal aortic aneurysm. Device manufacturers and regulators can leverage linked data sources to actively monitor long term outcomes in real world practice after cardiovascular interventions.

Advancing Peripheral Artery Disease Quality of Care and Outcomes Through Patient-Reported Health Status Assessment: A Scientific Statement From the American Heart Association.

Peripheral artery disease (PAD) is chronic in nature, and individualized chronic disease management is a central focus of care. To accommodate this reality, tools to measure the impact and quality of the PAD care delivered are necessary. Patient-reported outcomes (PROs) and instruments to measure them, that is, PRO measures, have been well studied in the research and clinical trial context, but a shift toward integrating them into clinical practice has yet to take place. A framework to use PRO measures as indicators of the quality of PAD care delivered, that is, PRO performance measures (PRO-PMs), is provided in this scientific statement. Measurement goals to consider by PAD clinical phenotypes are provided, as well as an overview of potential benefits of adopting PRO-PMs in the clinical practice of PAD care, including reducing unwanted variability and promoting health equity. A central discussion with considerations for risk adjustment of PRO-PMs, individualized PAD care, and the need for patient engagement strategies is offered. Furthermore, necessary conditions in terms of required competencies and training to handle PRO-PM data are discussed because the interpretation and handling of these data come with great responsibility and consequences for designing care that adopts a broader framework of risk that goes beyond the inclusion of biomedical variables. To conclude, health system perspectives and an agenda to reach the next steps in the implementation of PRO-PMs in PAD care are offered.

The financial implications of cardiac stress testing prior to abdominal aortic aneurysm repair.

BACKGROUND: The utilization and cost-effectiveness of stress testing before abdominal aortic aneurysm (AAA) repair remains insufficiently studied. We examined the variation and financial implications of stress testing, and their association with major adverse cardiovascular events (MACE). METHODS: We studied patients who underwent elective endovascular (EVAR) or open AAA repair (OAR) at Vascular Quality Initiative centers from 2015 to 2019. We grouped centers into quintiles of preoperative stress testing frequency. We calculated the risk of postoperative MACE, a composite of in-hospital myocardial infarction, heart failure, or death, for each center-quintile. We obtained charges for stress tests locally and applied these to the cohort to estimate charges per 1000 patients. RESULTS: We studied 32,459 patients (EVAR: 27,978; OAR: 4481; 283 centers). Stress test utilization varied across quintiles from 13.0% to 68.6% (median: 36.8%) before EVAR and 15.9% to 85.0% (median: 59.4%) before OAR. The risk of MACE was 1.4% after EVAR and 10.2% after OAR. There was a trend towards more common MACE after EVAR among centers with higher utilization of stress testing: 0.9% among centers in the lowest quintile, versus 1.7% in the highest quintile (p-trend = 0.068). There was no association between MACE and stress testing frequency for OAR (p-trend = 0.223). The estimated financial charges for stress testing before EVAR ranged from $125,806 per 1000 patients at 1st-quintile centers, to $665,975 at 5th-quintile centers. Charges before OAR ranged from $153,861 at 1st-quintile centers, to $825,473 at 5th-quintile centers. CONCLUSION: Stress test use before AAA repair is highly variable and associated with substantial cost, with an unclear association with postoperative MACE. This highlights the need for improved stress testing paradigms prior to surgery.

Creation of objective performance criteria among medical devices.

Objectives: Objective performance criteria (OPC) may serve as a tool to expedite the approval process and continue active surveillance of class III medical devices. Thus far, published guidance on the creation of OPC has been clinical area-specific. This study aimed to capture reflections from key stakeholders on the creation of OPC that may serve as a precursor for a formalized conceptual framework within the USA. Design: Reflections from key stakeholders and guidance from an advisory committee were captured to gain an understanding of the elements that are crucial to the generation of OPC. Setting: A non-probability sampling method using the purposive sampling strategy was employed to identify relevant stakeholders for engagement in semi-structured, open-ended, concept elicitation discussions. Participants: Stakeholders involved in the generation of OPC. Main outcome measures: Elements and themes regarding the priorities of, experiences with, roles within and perceived challenges associated with OPC creation captured through a phenomenological approach. Results: A total of 27 participants were engaged to represent the following contributors: representatives of registries, health systems, health technology assessment bodies, clinicians, device application reviewers, payers, patients, patient representatives, patient caregivers, device manufacturers, data coordinators, data analysts and data informaticians. Consensus was achieved on the five core elements: (1) identification of medical devices, (2) engagement of key stakeholders, (3) selection of data source, (4) performance of appropriate statistical analyses and (5) reporting of findings. The engagement of key stakeholders (38%) was cited most frequently as the most important core element. Access to meaningful and high-quality data sources (47%) was the most frequently mentioned challenge. Conclusions: The reflections from the participants identified five elements to be considered when generating an OPC within class III medical devices and may provide the needed foundation for the development of official guidance on OPC generation.

Contemporary incidence, outcomes, and survival associated with endovascular aortic aneurysm repair conversion to open repair among Medicare beneficiaries.

OBJECTIVE: The widespread application of endovascular abdominal aortic aneurysm repair (EVAR) has ushered in an era of requisite postoperative surveillance and the potential need for reintervention. The national prevalence and results of EVAR conversion to open repair, however, remain poorly defined. The purpose of this analysis was to define the incidence of open conversion and its associated outcomes. METHODS: The SVS Vascular Quality Initiative EVAR registry linked to Medicare claims via Vascular Implants Surveillance and Interventional Outcomes Network was queried for open conversions after initial EVAR procedures from 2003 to 2016. Cumulative conversion incidence within up to 5 years after EVAR and outcomes after open intervention were determined. Multivariable logistic regressions were used to identify independent predictors of conversion and mortality. RESULTS: Among 15,937 EVAR patients, 309 (1.9%) underwent an open conversion: 43% (n = 132) early (<30 days) and 57% (n = 177) late (>30 days). The longitudinally observed rate of conversion was constant over time, as well as by geographic region. Independent predictors of conversion included female sex (hazard ratio [HR], 1.49; P < .001), aneurysm diameter or more than 6.0 cm at the time of index EVAR (HR, 1.74; P < .001), nonelective repair (compared with elective presentation: HR, 1.72; P < .001), and aortouni-iliac repairs (HR, 2.19; P < .001). In contrast, adjunctive operative procedures such as endo-anchors or cuff extensions (HR, 0.62; P = .06) were protective against long-term conversion. Both early (HR, 1.6; P < .001) and late (HR, 1.26; P = .07) open conversions were associated with significant 30-day (total cohort, 15%) and 1-year mortality (total cohort, 25%). Patients undergoing open conversion experienced high rates of 30-day readmission (42%) and cardiac (45%), renal (32%), and pulmonary (30%) complications. CONCLUSIONS: This large, registry-based analysis is among the first to document the incidence and outcomes for open conversion after EVAR in a national cohort with long-term follow-up. Importantly, women, patients with large aneurysms, and complex anatomy, as well as urgent or emergent EVARs are at an increased risk for open conversion. It seems that more conversions are performed in the early postoperative period, despite perceptions that conversion is a delayed phenomenon. In all instances, conversion is associated with significant morbidity and mortality and highlights the importance of appropriate patient selection at the time of index EVAR.