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The COVID-19 pandemic necessitated postponement of vascular surgery procedures nationally. Whether procedure volumes have since recovered remains undefined. Therefore, our objective was to quantify changes in procedure volumes and determine whether surgical volume has returned to its prepandemic baseline.

IMPORTANCE: Claims data with International Statistical Classification of Diseases, Tenth Revision (ICD-10) codes are routinely used in clinical research. However, the use of ICD-10 codes to define incident stroke has not been validated against expert-adjudicated outcomes in the US population. OBJECTIVE: To develop and validate the accuracy of an ICD-10 code list to detect incident stroke events using Medicare inpatient fee-for-service claims data. DESIGN, SETTING, AND PARTICIPANTS: This cohort study used data from 2 prospective population-based cohort studies, the Atherosclerosis Risk in Communities (ARIC) study and the Reasons for Geographic and Racial Differences in Stroke (REGARDS) study, and included participants aged 65 years or older without prior stroke who had linked Medicare claims data. Stroke events in the ARIC and REGARDS studies were identified via active surveillance and adjudicated by expert review. Medicare-linked ARIC data (2016-2018) were used to develop a list of ICD-10 codes for incident stroke detection. The list was validated using Medicare-linked REGARDS data (2016-2019). Data were analyzed from September 1, 2022, through September 30, 2023. EXPOSURES: Stroke events detected in Medicare claims vs expert-adjudicated stroke events in the ARIC and REGARDS studies. MAIN OUTCOMES AND MEASURES: The main outcomes were sensitivity and specificity of incident stroke detection using ICD-10 codes. RESULTS: In the ARIC study, there were 110 adjudicated incident stroke events among 5194 participants (mean [SD] age, 80.1 [5.3] years) over a median follow-up of 3.0 (range, 0.003-3.0) years. Most ARIC participants were women (3160 [60.8%]); 993 (19.1%) were Black and 4180 (80.5%) were White. Using the primary diagnosis code on a Medicare billing claim, the ICD-10 code list had a sensitivity of 81.8% (95% CI, 73.3%-88.5%) and a specificity of 99.1% (95% CI, 98.8%-99.3%) to detect incident stroke. Using any diagnosis code on a Medicare billing claim, the sensitivity was 94.5% (95% CI, 88.5%-98.0%) and the specificity was 98.4% (95% CI, 98.0%-98.8%). In the REGARDS study, there were 140 adjudicated incident strokes among 6359 participants (mean [SD] age, 75.8 [7.0] years) over a median follow-up of 4.0 (range, 0-4.0) years. More than half of the REGARDS participants were women (3351 [52.7%]); 1774 (27.9%) were Black and 4585 (72.1%) were White. For the primary diagnosis code, the ICD-10 code list had a sensitivity of 70.7% (95% CI, 63.2%-78.3%) and a specificity of 99.1% (95% CI, 98.9%-99.4%). For any diagnosis code, the ICD-10 code list had a sensitivity of 77.9% (95% CI, 71.0%-84.7%) and a specificity of 98.9% (95% CI, 98.6%-99.2%). CONCLUSIONS AND RELEVANCE: These findings suggest that ICD-10 codes could be used to identify incident stroke events in Medicare claims with moderate sensitivity and high specificity.

Atherosclerotic disease of the innominate artery (IA) is rare and can lead to cerebral, upper extremity, and vertebral steal symptoms. Nonocclusive lesions can be treated with endovascular interventions, often with a hybrid approach while performing a right carotid endarterectomy (RCEA). Calcified IA lesions have a high risk of embolization to bilateral cerebral hemispheres. Occlusive lesions may require treatment through a median sternotomy and bypass. The purpose of our study is to review our short-term and long-term outcomes of IA revascularization.

Endovascular therapy for chronic mesenteric ischemia (CMI) is the mainstay of treatment. Duplex velocity criteria within stented mesenteric vessels are not well established. We describe single-center outcomes of mesenteric stenting for CMI and analyze duplex velocities associated with in-stent restenosis (ISR).

For patients with abdominal aortic aneurysm (AAA), randomized trials have found endovascular AAA repair (EVAR) is associated with lower perioperative morbidity and mortality than open surgical repair (OSR). However, OSR has fewer long-term aneurysm-related complications, such as endoleak or late rupture. Patients treated with EVAR and OSR have similar survival rates within two years after surgery, and OSR does not require intensive surveillance. Few have examined if patient preferences are aligned with the type of treatment they receive for their AAA. Although many assume that patients may universally prefer the less-invasive nature of EVAR, our preliminary work suggests that patients who value the lower risk of late complications may prefer OSR.

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Endovascular aortic aneurysm repair (EVR) has a major financial impact on health care systems. We characterized reimbursement for index EVR hospitalizations among Medicare beneficiaries having surgery at Vascular Quality Initiative (VQI) centers.

Differential access to new technologies may contribute to racial disparities in surgical outcomes but has not been well-studied in the treatment of carotid artery stenosis. We examined race-based differences in adoption and outcomes of transcarotid artery revascularization (TCAR) among high-risk non-Hispanic (NH) Black and NH white adults undergoing carotid revascularization.

The use of fenestrated endovascular devices for repair of complex aortic aneurysms has increased to nearly 5,000 implantations annually among Medicare patients in the United States in recent years. Given that nearly all aspects of treatment for minimally invasive aortic intervention rely on medical devices to better care for patients with vascular disease, clearly understanding how new and innovative technology evolves over the life cycle of a medical device is an essential skill set for cardiovascular physicians. Despite the need for this understanding, there is no standard framework upon which cardiovascular physicians, regulators, and patients can rely on to better understand the evolution of evidence from product inception through adoption and long-term effectiveness evaluation. As the aforementioned devices are increasingly and broadly used, the need for a formal framework for regulation and device approval has emerged. The goal of this review is to describe the Idea, Development, Exploration, Assessment, Long-term Study Framework for Devices (IDEAL-D). This framework is a model developed recently by an international panel of experts dedicated to better understanding the data steps necessary to bring a device from idea to routine practice and further to marketing, approval, and monitoring. In this review, we use the example of fenestrated endovascular aortic devices to illustrate the IDEAL-D framework, how it can help cardiovascular physicians improve their understanding of new technology, and the evidence which surrounds it from inception to long-term use.

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Most existing series of acute aortic occlusion (AAO) predate the changes in surgical and endovascular therapy of the last 2 decades. We examined the contemporary management and outcomes of AAO.

ObjectiveTo evaluate long term outcomes (reintervention and late rupture of abdominal aortic aneurysm) of aortic endografts in real world practice using linked registry claims data.DesignObservational surveillance study.Setting282 centers in the Vascular Quality Initiative Registry linked to United States Medicare claims (2003-18).Participants20 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 measuresReintervention 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.ResultsMedian 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.ConclusionsThe 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.

Introduction:Carotid artery revascularization - including endarterectomy (CEA) and stenting (CAS) - is the standard of care for severe carotid stenosis. The contemporary geographic dispersion of CAS relative to CEA is not well described and has implications on access-to-care in the United States.Methods:We identified 83,825 patients undergoing CEA and CAS between 2015-2019 among participating centers in the Vascular Quality Initiative. Patients were stratified according to type of revascularization and by urban vs. rural geographical designation based on Rural Urban Commuting Area coding. For CEA and CAS cohorts, demographic profiles and clinical outcomes were compared between urban vs. rural patients. Multivariable logistic regression was performed to estimate the association of geographical locale with 30-day and 1-year outcomes.Results:There was a progressive annual increase in CAS, CEA, and the relative ratio of CAS/CEA performed throughout the study period. (Figure 1) The proportion of carotid stents increased from 25.1% in 2015 to 48.7% in 2019. This finding was consistent in both rural (28.7% to 51.4%) and urban areas (23.9% to 47.7%). In both CEA and CAS cohorts, demographic characteristics, medical profiles, and in-hospital outcomes were overall comparable between rural and urban subgroups. For CAS, geographic locale was not associated with 30-day or 1-year mortality (OR 1.12, 95% CI 0.89-1.41; p=0.34 and OR 1.11, 95% CI 0.97-1.28; p=0.13, respectively). Similarly for CEA, 30-day and 1-year mortality were not significantly different between rural vs. urban subgroups (OR 1.04, 95% CI 0.84-1.29; p=0.72 and OR 1.05, 95% CI 0.94-1.17; p=0.40).Conclusions:Over a short time period, there has been progressive uptake in the relative use of CAS and CEA across the United States. There were no significant differences in either short- or long-term outcomes of carotid revascularization based on rurality.

Introduction:The use of stress testing prior to abdominal aortic aneurysm (AAA) repair is highly variable. We examined the financial implications of this variation and its impact on postoperative cardiac events.Methods:We studied patients who underwent elective endovascular (EVAR) or open AAA repair at Vascular Quality Initiative participating centers from 2015–2019. We grouped centers into quintiles by their frequency of preoperative stress testing. We calculated rates of major adverse cardiovascular events (MACE), a composite of in-hospital myocardial infarction, stroke, heart failure, or death, for each quintile. We applied the charges for electrocardiographic, echocardiographic, and nuclear stress tests at our institution in 2019 to the study population to calculate expected charges per 1,000 patients.Results:We studied 27,978 patients who underwent EVAR (mean age: 73.5 ±8.5 years, 81.7% male) and 4,481 who underwent open AAA repair (mean age: 69.5 ±8.1 years, 75.1% male). Stratifying by quintile, stress test frequency ranged from 13.0% to 68.6% (mean: 37.9%) among EVAR patients and 15.9% to 85.0% (mean: 52.8%) among open AAA repair (Figure). The rate of MACE was 1.4% after EVAR and 10.2% after open AAA repair. MACE after EVAR increased with the frequency of stress testing and was 0.9% at 1stquintile centers vs 1.7% at 5thquintile centers (p-trend=0.033). There was no association between MACE and stress testing for open AAA repair (p-trend=0.192). The estimated charges for stress testing prior to EVAR was $125,806 per 1,000 patients at 1stquintile centers, and $664,975 at 5thquintile centers, while charges prior to open AAA repair were $153,861 per 1,000 patients at 1stquintile centers, and $825,473 at 5thquintile centers.Conclusions:More frequent stress testing is associated with high cost without a reduction in MACE. This lack of return on investment highlights the need for more judicious stress test use prior to AAA surgery.

IMPORTANCE: Transcarotid artery revascularization (TCAR) may serve as a safer alternative to carotid endarterectomy (CEA) for certain patients with carotid artery stenosis. OBJECTIVE: To determine the center-level association of TCAR adoption with overall perioperative outcomes for TCAR and CEA combined at centers performing both procedures. DESIGN, SETTING, AND PARTICIPANTS: This comparative-effectiveness research was conducted with a difference-in-difference analysis using retrospective data from 2015 to 2019 from the Vascular Quality Initiative registry, a consortium of more than 400 centers in North America. Included patients underwent TCAR or CEA for carotid artery stenosis. Patients who underwent transfemoral carotid stenting were excluded. Data were analyzed from December 2019 through August 2020. EXPOSURES: Center-level adoption of TCAR vs not. MAIN OUTCOMES AND MEASURES: The rate of major adverse cardiovascular events (MACE), a composite of in-hospital stroke, myocardial infarction, or death at 30 days, was measured. RESULTS: Among 86?027 patients who underwent revascularization for carotid artery stenosis, 7664 patients (8.9%) underwent TCAR (mean [SD] age, 73.1 [9.6] years; 2788 [36.4%] women; 6938 White patients [90.6%]; and 3741 patients with symptoms [48.8%]) and 78?363 patients (91.1%) underwent CEA (mean [SD] age, 70.6 [9.2] years; 30?928 [39.5%] women; 70?663 White patients [90.2%]; and 37?883 patients with symptoms [48.3%]). The number of centers performing both TCAR and CEA increased from 15 centers in 2015 to 247 centers in 2019, a more than 16-fold increase. The proportion of all carotid procedures that were TCARs increased from 90 of 12?276 (0.7%) in 2015 to 2718 of 15?956 (17.0%) in 2019, a 24-fold increase. Overall, the crude rate of MACE was similar for TCAR and CEA (178 patients [2.3%] after TCAR vs 1842 patients [2.4%] after CEA; P?=?.91). However, the rate of MACE over time decreased for CEA (406 of 16?404 patients [2.5%] in 2015 vs 189 of 10?097 patients [1.9%] in 2019; P for trend?<?.001). The rate of MACE over time decreased for TCAR as well, but the change was not statistically significant (4 of 128 patients [3.1%] in 2016 vs 59 of 2718 patients [2.2%] in 2019; P for trend?=?.07). Difference-in-difference analysis demonstrated that centers that adopted TCAR had a 10% decrease in the likelihood of MACE at 12 months after TCAR adoption vs if those centers had continued to perform CEA alone (odds ratio, 0.90; 95% CI, 0.81-0.99; P?=?.04). CONCLUSIONS AND RELEVANCE: This comparative-effectiveness study of a cohort of patients who underwent TCAR or CEA found that availability of TCAR at a hospital was associated with a decrease in the likelihood of perioperative MACE after carotid revascularization.

•In a cohort of 10 patients, endovascular repair of the proximal aortic arch was associated with good mid-term outcomes in patients considered too high-risk for open repair.•Reimbursement did not adequately cover treatment costs, with net technical margins being negative in nearly all cases (mean net technical margin was -$25,055 ± $18,746).•In patients ineligible for open proximal aortic arch repair due to lack of fitness for surgery, TEVAR with adjunctive endovascular branch grafts, or parallel grafts, and extra-anatomic bypass presents a safe surgical option with high rates of technical success but high technical costs per patient.

The benefit of long-term anticoagulation or dual antiplatelet therapy (DAPT) for patients with extra-anatomic bypasses to the lower extremity remains poorly defined. Our study analyzed the real-world use of antithrombotic therapy in patients with extra-anatomic bypass grafts to the lower extremity and compared graft and patient outcomes by antithrombotic regimen.

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