Characterization of Endovascular Abdominal Aortic Aneurysm Repair Surveillance in the Vascular Quality Initiative

Introduction: The coronavirus disease 2019 (COVID-19) pandemic’s impact on vascular procedural volumes and outcomes has not been fully characterized. Methods: Volume and outcome data before (1/2019 – 2/2020), during (3/2020 – 4/2020), and following (5/2020 – 6/2020) the initial pandemic surge were obtained from the Vascular Quality Initiative®. Volume changes were determined using interrupted Poisson time series regression. Adjusted mortality was estimated using multivariable logistic regression. Results: The final cohort comprised 57,181 patients from 147 US and Canadian sites. Overall procedure volumes fell 35.2% (95% CI 31.9%, 38.4%, p < 0.001) during and 19.8% (95% CI 16.8%, 22.9%, p < 0.001) following the surge, compared with presurge months. Procedure volumes fell 71.1% for claudication (95% CI 55.6%, 86.4%, p < 0.001) and 15.9% for chronic limb-threatening ischemia (CLTI) (95% CI 11.9%, 19.8%, p < 0.001) but remained unchanged for acute limb ischemia (ALI) when comparing surge to presurge months. Adjusted mortality was significantly higher among those with claudication (0.5% vs 0.1%; OR 4.38 [95% CI 1.42, 13.5], p = 0.01) and ALI (6.4% vs 4.4%; OR 2.63 [95% CI 1.39, 4.98], p = 0.003) when comparing postsurge with presurge periods. Conclusion: The first North American COVID-19 pandemic surge was associated with a significant and sustained decline in both elective and nonelective lower-extremity vascular procedural volumes. When compared with presurge patients, in-hospital mortality increased for those with claudication and ALI following the surge.

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“…Each of these modules prospectively collects > 100 demographic, comorbid, procedure, and outcome variables. [12][13][14]…”

Section: Data Sourcementioning

confidence: 99%

North American lower-extremity revascularization and amputation during COVID-19: Observations from the Vascular Quality Initiative

Lou

Kennedy²,

Menard

et al. 2021

Vasc Med

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“…With centre-level feedback serving as a cornerstone of the VQI mission, the VISION team distributed their first centre-specific SRS reports in 2019 using the matched data sets for EVAR 1 13. In 2021, this effort was expanded to include SRS reports for EVAR procedures, asymptomatic elective AAA repairs (EVAR or open repair), and carotid interventions.…”

Section: Main Findings With Discussionmentioning

confidence: 99%

Survival, reintervention and surveillance reports: long-term, centre-level evaluation and feedback of vascular interventions

Fowler

Gladders

Moore

et al. 2022

BMJ Surg Interv Health Technologies

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The combination of registry and administrative claims data have facilitated research and quality improvement efforts. Using Vascular Quality Initiative (VQI) registry data and Medicare claims we have generated centre-specific survival, reintervention and surveillance reports which benchmark participating centres’ performance to the VQI as a whole and to published guidelines. In 2021, we distributed these reports to 303 participating centres. These reports offer an opportunity for centres to evaluate their performance and identify focus areas for quality improvement work.

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“…Measurement of each of these outcomes has been validated in previous work using a combination of data from the VQI dataset and Medicare claims. 5 23 24 25 Specifically, reintervention was defined as any procedure related to either the aneurysm or the index aneurysm repair, and this definition has been validated using a clinical chart review as published in our previous work, with greater than 92% specificity and 96% sensitivity. 23 26 Rupture of an abdominal aortic aneurysm after EVAR was defined as having a diagnosis of ruptured abdominal aortic aneurysm after discharge, in conjunction with a reintervention or death that occurred 14 days before or after the procedure.…”

Section: Methodsmentioning

confidence: 99%

“…Measurement of each of these outcomes has been validated in previous work using a combination of data from the VQI dataset and Medicare claims 5232425. Specifically, reintervention was defined as any procedure related to either the aneurysm or the index aneurysm repair, and this definition has been validated using a clinical chart review as published in our previous work, with greater than 92% specificity and 96% sensitivity 2326.…”

Section: Methodsmentioning

confidence: 99%

“…25 Finally, to ensure all patients who received EVAR devices were monitored similarly after implantation, we examined the occurrence of failures in surveillance, defined as the end of a 15 month period after EVAR during which no abdominal computed tomography, magnetic resonance imaging, or ultrasonography was performed. 24 For each outcome, we censored patients at the time of death, the end of Medicare fee-for-service entitlement, or the end of the study (…”

Section: Main Exposure Variablementioning

confidence: 99%

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

Goodney

Mao

Columbo

et al. 2022

BMJ

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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.

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Characterization of Endovascular Abdominal Aortic Aneurysm Repair Surveillance in the Vascular Quality Initiative

Cited by 8 publications

References 5 publications

North American lower-extremity revascularization and amputation during COVID-19: Observations from the Vascular Quality Initiative

North American lower-extremity revascularization and amputation during COVID-19: Observations from the Vascular Quality Initiative

Survival, reintervention and surveillance reports: long-term, centre-level evaluation and feedback of vascular interventions

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

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