A multiregional registry experience using an electronic medical record to optimize data capture for longitudinal outcomes in endovascular abdominal aortic aneurysm repair

Hye, Robert J.; Inui, Tazo; Anthony, Faith; Kiley, Mary-Lou; Chang, Robert W.; Rehring, Thomas F.; Nelken, Nicolas A.; Hill, Bruce C.

doi:10.1016/j.jvs.2014.12.055

Cited by 15 publications

(8 citation statements)

References 13 publications

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“… 16 Some research has examined the use of automated algorithms embedded in electronic medical records to identify short-term adverse outcomes among patients in whom devices were implanted. 17 Adverse events can also be detected by electronic sensors within medical devices that automatically submit data to physicians or a monitoring agency when irregularities arise, although these are in various stages of development and testing. 18 Other research exploring the reporting of medical errors in general found that, similar to this study, individual factors (healthcare professional view that errors were inevitable and it was pointless to report them) and organisational factors (lack of reporting processes and systems) influenced reporting behaviour.…”

Section: Discussionmentioning

confidence: 99%

Factors influencing the reporting of adverse medical device events: qualitative interviews with physicians about higher risk implantable devices

et al. 2017

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BackgroundPostmarket surveillance of medical devices is reliant on physician reporting of adverse medical device events (AMDEs). Little is known about factors that influence whether and how physicians report AMDEs, an essential step in developing behaviour change interventions. This study explored factors that influence AMDE reporting.MethodsQualitative interviews were conducted with physicians who differed by specialties that implant cardiovascular and orthopaedic devices prone to AMDEs, geography and years in practice. Participants were asked if and how they reported AMDEs, and the influencing factors. Themes were identified inductively using constant comparative technique, and reviewed and discussed by the research team on four occasions.ResultsTwenty-two physicians of varying specialty, region, organisation and career stage perceived AMDE reporting as unnecessary, not possible or futile due to multiple factors. Physicians viewed AMDEs as an expected part of practice that they could manage by switching to different devices or developing work-around strategies for problematic devices. Physician beliefs and behaviour were reinforced by limited healthcare system capacity and industry responsiveness. The healthcare system lacked processes and infrastructure to detect, capture, share and act on information about AMDEs, and constrained device choice through purchasing contracts. The device industry did not respond to reports of AMDEs from physicians or improve their products based on such reports. As a result, participants said they used devices that were less than ideal for a given patient, leading to suboptimal patient outcomes.ConclusionsThere may be little point in solely educating or incentivising individual physicians to report AMDEs unless environmental conditions are conducive to doing so. Future research should explore policies that govern AMDEs and investigate how to design and implement postmarket surveillance systems.

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Section: Discussionmentioning

confidence: 99%

Factors influencing the reporting of adverse medical device events: qualitative interviews with physicians about higher risk implantable devices

et al. 2017

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Section: The Kaiser Permanente Endovascular Stent Graft Registrymentioning

confidence: 99%

“…In three studies, the proportion of participants requiring reintervention was 10.3%, 115 10.8% 112 and 15% (median of 32.2 months' follow-up), respectively. 116 The study by Hye et al 112 reported an overall reintervention rate of 10.8%. Of the reinterventions, 4.6% were for endoleaks, 1.7% were for stenosis, 1.5% were for thrombosis, 1.3% were for occlusion, 1.6% were for device malfunction, 1.3% were for haematoma/seroma, 0.6% were for pseudoaneurysm, 0.6% were for abdominal compartment syndrome, 0.5% were for infection and 0.4% were for rupture.…”

Section: The Kaiser Permanente Endovascular Stent Graft Registrymentioning

confidence: 99%

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Contrast-enhanced ultrasound and/or colour duplex ultrasound for surveillance after endovascular abdominal aortic aneurysm repair: a systematic review and economic evaluation

Brazzelli

Hernández

Sharma

et al. 2018

Health Technol Assess

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Background Endovascular abdominal aortic aneurysm repair (EVAR) of abdominal aortic aneurysm (AAA) is less invasive than open surgery, but may be associated with important complications. Patients receiving EVAR require long-term surveillance to detect abnormalities and direct treatments. Computed tomography angiography (CTA) has been the most common imaging modality adopted for EVAR surveillance, but it is associated with repeated radiation exposure and the risk of contrast-related nephropathy. Colour duplex ultrasound (CDU) and, more recently, contrast-enhanced ultrasound (CEU) have been suggested as possible, safer, alternatives to CTA. Objectives To assess the clinical effectiveness and cost-effectiveness of imaging strategies, using either CDU or CEU alone or in conjunction with plain radiography, compared with CTA for EVAR surveillance. Data sources Major electronic databases were searched, including MEDLINE, EMBASE, Science Citation Index, Scopus’ Articles-in-Press, Cochrane Central Register of Controlled Trials (CENTRAL), Database of Abstracts of Reviews of Effects (DARE) and NHS Economic Evaluation Database from 1996 onwards. We also searched for relevant ongoing studies and conference proceedings. The final searches were undertaken in September 2016. Methods We conducted a systematic review of randomised controlled trials and cohort studies of patients with AAAs who were receiving surveillance using CTA, CDU and CEU with or without plain radiography. Three reviewers were involved in the study selection, data extraction and risk-of-bias assessment. We developed a Markov model based on five surveillance strategies: (1) annual CTA; (2) annual CDU; (3) annual CEU; (4) CDU together with CTA at 1 year, followed by CDU on an annual basis; and (5) CEU together with CTA at 1 year, followed by CEU on an annual basis. All of these strategies also considered plain radiography on an annual basis. Results We identified two non-randomised comparative studies and 25 cohort studies of interventions, and nine systematic reviews of diagnostic accuracy. Overall, the proportion of patients who required reintervention ranged from 1.1% (mean follow-up of 24 months) to 23.8% (mean follow-up of 32 months). Reintervention was mainly required for patients with thrombosis and types I–III endoleaks. All-cause mortality ranged from 2.7% (mean follow-up of 24 months) to 42% (mean follow-up of 54.8 months). Aneurysm-related mortality occurred in < 1% of the participants. Strategies based on early and mid-term CTA and/or CDU and long-term CDU surveillance were broadly comparable with those based on a combination of CTA and CDU throughout the follow-up period in terms of clinical complications, reinterventions and mortality. The economic evaluation showed that a CDU-based strategy generated lower expected costs and higher quality-adjusted life-year (QALYs) than a CTA-based strategy and has a 63% probability of being cost-effective at a £30,000 willingness-to-pay-per-QALY threshold. A CEU-based strategy generated more QALYs, but at higher costs, and became cost-effective only for high-risk patient groups. Limitations Most studies were rated as being at a high or moderate risk of bias. No studies compared CDU with CEU. Substantial clinical heterogeneity precluded a formal synthesis of results. The economic model was hindered by a lack of suitable data. Conclusions Current surveillance practice is very heterogeneous. CDU may be a safe and cost-effective alternative to CTA, with CTA being reserved for abnormal/inconclusive CDU cases. Future work Research is needed to validate the safety of modified, more-targeted surveillance protocols based on the use of CDU and CEU. The role of radiography for surveillance after EVAR requires clarification. Study registration This study is registered as PROSPERO CRD42016036475. Funding The National Institute for Health Research Health Technology Assessment programme.

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“…Previous clinical studies had reported a variable prevalence of concomitant coronary artery disease (CAD) ranging from 5 to 46% in patients with aortic disease ( 4 – 6 ). Some studies have shown that patients diagnosed with abdominal aortic aneurysm presented a higher prevalence of CAD, which accounts for worse prognosis especially higher perioperative myocardial infarction and mortality in those undergoing aortic procedure ( 7 ).…”

Section: Introductionmentioning

confidence: 99%

Coronary artery disease as an independent predictor of short-term and long-term outcomes in patients with type-B aortic dissection undergoing thoracic endovascular repair

Luo

Lin

et al. 2022

Front. Cardiovasc. Med.

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Background and aimsPrevious studies reported a high prevalence of concomitant coronary artery disease (CAD) in patients with Type B aortic dissection (TBAD). However, there is too limited data on the impact of CAD on prognosis in patients with TBAD. The present study aimed to assess the short-term and long-term impact of CAD on patients with acute or subacute TBAD undergoing thoracic endovascular aortic repair (TEVAR).MethodsWe retrospectively evaluated 463 patients with acute or subacute TBAD undergoing TEVAR from a prospectively maintained database from 2010 to 2017. CAD was defined before TEVAR by coronary angiography. Multivariable logistic and cox regression analyses were performed to evaluate the relationship between CAD and the short-term as well as long-term outcomes.ResultsAccording to the results of coronary angiography, the 463 patients were divided into the following two groups: CAD group (N = 148), non-CAD group (N = 315). In total, 12 (2.6%) in-hospital deaths and 54 (12%) all-cause deaths following a median follow-up of 48.1 months were recorded. Multivariable analysis revealed that CAD was an independent predictor of in-hospital major adverse clinical events (MACE) (odd ratio [OR], 2.33; 95% confidence interval [CI], 1.07–5.08; p = 0.033), long-term mortality [hazard ratio (HR), 2.11, 95% CI, 1.19–3.74, P = 0.011] and long-term MACE (HR, 1.95, 95% CI, 1.26–3.02, P = 0.003). To further clarify the relationship between the severity of CAD and long-term outcomes, we categorized patients into three groups: zero-vessel disease, single-vessel disease and multi-vessel disease. The long-term mortality (9.7 vs. 14.4 vs. 21.2%, P = 0.045), and long-term MACE (16.8 vs. 22.2 vs. 40.4%, P = 0.001) increased with the number of identified stenosed coronary vessels. Multivariable analysis indicated that, multi-vessel disease was independently associated with long-term mortality (HR, 2.38, 95% CI, 1.16–4.89, P = 0.018) and long-term MACE (HR, 2.79, 95% CI, 1.65–4.73, P = 0.001), compared with zero-vessel disease.ConclusionsCAD was associated with short-term and long-term worse outcomes in patients with acute or subacute TBAD undergoing TEVAR. Furthermore, the severity of CAD was also associated with worse long-term prognosis. Therefore, CAD could be considered as a useful independent predictor for pre-TEVAR risk stratification in patients with TBAD.

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A multiregional registry experience using an electronic medical record to optimize data capture for longitudinal outcomes in endovascular abdominal aortic aneurysm repair

Cited by 15 publications

References 13 publications

Factors influencing the reporting of adverse medical device events: qualitative interviews with physicians about higher risk implantable devices

Factors influencing the reporting of adverse medical device events: qualitative interviews with physicians about higher risk implantable devices

Contrast-enhanced ultrasound and/or colour duplex ultrasound for surveillance after endovascular abdominal aortic aneurysm repair: a systematic review and economic evaluation

Coronary artery disease as an independent predictor of short-term and long-term outcomes in patients with type-B aortic dissection undergoing thoracic endovascular repair

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