The challenges of novel interventions in complex aortic disease.
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ABSTRACT:
SUBMITTER: Guo M
PROVIDER: S-EPMC7802690 | biostudies-literature | 2020 Dec
REPOSITORIES: biostudies-literature
Publications
The challenges of novel interventions in complex aortic disease.
Guo Marissa M Naeem Aroma A Yang Bo B
JTCVS techniques 20201008
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Project description:BackgroundFidelity in complex behavioural interventions is underexplored and few comprehensive or detailed fidelity studies report on specific procedures for monitoring fidelity. Using Bellg's popular Treatment Fidelity model, this paper aims to increase understanding of how to practically and comprehensively assess fidelity in complex, group-level, interventions.Approach and lessons learnedDrawing on our experience using a mixed methods approach to assess fidelity in the INFORM study (Improving Nursing home care through Feedback On perfoRMance data-INFORM), we report on challenges and adaptations experienced with our fidelity assessment approach and lessons learned. Six fidelity assessment challenges were identified: (1) the need to develop succinct tools to measure fidelity given tools tend to be intervention specific, (2) determining which components of fidelity (delivery, receipt, enactment) to emphasize, (3) unit of analysis considerations in group-level interventions, (4) missing data problems, (5) how to respond to and treat fidelity 'failures' and 'deviations' and lack of an overall fidelity assessment scheme, and (6) ensuring fidelity assessment doesn't threaten internal validity.Recommendations and conclusionsSix guidelines, primarily applicable to group-level studies of complex interventions, are described to help address conceptual, methodological, and practical challenges with fidelity assessment in pragmatic trials. The current study offers guidance to researchers regarding key practical, methodological, and conceptual challenges associated with assessing fidelity in pragmatic trials. Greater attention to fidelity assessment and publication of fidelity results through detailed studies such as this one is critical for improving the quality of fidelity studies and, ultimately, the utility of published trials.Trial registrationClinicalTrials.gov NCT02695836. Registered on February 24, 2016.
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Project description:BackgroundDespite favourable results from past meta-analyses, some recent large trials have not found heart failure (HF) disease management programs to be beneficial. To explore reasons for this, we evaluated evidence from existing meta-analyses.MethodsSystematic review incorporating meta-review was used. We selected meta-analyses of randomized controlled trials published after 1995 in English that examined the effects of HF disease management programs on key outcomes. Databases searched: MEDLINE, EMBASE, Cochrane Database of Systematic Reviews (CDSR), DARE, NHS EED, NHS HTA, Ageline, AMED, Scopus, Web of Science and CINAHL; cited references, experts and existing reviews were also searched.Results15 meta-analyses were identified containing a mean of 18.5 randomized trials of HF interventions +/- 10.1 (range: 6 to 36). Overall quality of the meta-analyses was very mixed (Mean AMSTAR Score = 6.4 +/- 1.9; range 2-9). Reporting inadequacies were widespread around populations, intervention components, settings and characteristics, comparison, and comparator groups. Heterogeneity (statistical, clinical, and methodological) was not taken into account sufficiently when drawing conclusions from pooled analyses.ConclusionsMeta-analyses of heart failure disease management programs have promising findings but often fail to report key characteristics of populations, interventions, and comparisons. Existing reviews are of mixed quality and do not adequately take account of program complexity and heterogeneity.
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Project description:BackgroundHealth services and implementation researchers often seek to capture the implementation process of complex interventions yet explicit guidance on how to capture this process is limited. Medical record review is a commonly used methodology, especially when used as a proxy for provider behavior, with recognized benefits and limitations. The purpose of this study was to test the feasibility of chart review to measure implementation and offer recommendations for future researchers using this method to capture the implementation process.MethodsGrounded in qualitative research methods, we measured the implementation of a transitional care intervention for older adults with dementia being discharged from the hospital. We adapted the operationalization of the intervention's components to suit chart review methods, sought input from hospital providers before and after data collection, and assessed the agreement between the results of our chart review and provider-report.FindingsWe believe chart review can be used effectively as a method for capturing the implementation process and provide future researchers with a list of recommendations based on our experience including understanding the nuance between data extraction versus data abstraction, allowing for large amounts of data not pre-specified in the data collection instrument to be collected, and purposefully and iteratively engaging the providers who are entering data into the chart.Major themesMeasuring the implementation of complex interventions is a cornerstone in health services research and with the relative convenience and low costs of using chart data, we believe with more use and refinement this methodology could emerge as a valuable and widely used method in the field.
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Project description:Coronary artery disease (CAD) is highly prevalent in patients with severe aortic stenosis (AS). The management of CAD is a central aspect of the work-up of patients undergoing transcatheter aortic valve implantation (TAVI), but few data are available on this field and the best percutaneous coronary intervention (PCI) practice is yet to be determined. A major challenge is the ability to elucidate the severity of bystander coronary stenosis independently of the severity of aortic valve stenosis and subsequent impact on blood flow. The prognostic role of CAD in patients undergoing TAVI is being still debated and the benefits and the best timing of PCI in this context are currently under evaluation. Additionally, PCI in the setting of advanced AS poses some technical challenges, due to the complex anatomy, risk of hemodynamic instability, and the increased risk of bleeding complications. This review aims to provide a comprehensive synthesis of the available literature on myocardial revascularization in patients with severe AS undergoing TAVI. This work can assist the Heart Team in individualizing decisions about myocardial revascularization, taking into account available diagnostic tools as well as the risks and benefits.
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Project description:Aortic Valve Disease (AVD) is the most common Valvular Heart Disease (VHD), affecting millions of people worldwide. Severe AVD is treated in most cases with prosthetic aortic valve replacement, which involves the substitution of the native aortic valve with a prosthetic one. In this review we will discuss the different types of prosthetic aortic valves available for implantation and the challenges faced by patients, medical doctors, researchers and manufacturers, as well as the approaches that are taken to overcome them.
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Project description:IntroductionArterial tortuosity has emerged as a predictor of adverse outcomes in congenital aortopathies using 3D reconstructed images. We validated a new method to estimate aortic arch tortuosity on 2D CT. We hypothesize that arch tortuosity may identify bicuspid aortic valve (BAV) patients at high risk to develop thoracic aortic aneurysms or aortic dissections (TAD).MethodsBAV subjects with chest CT scans were retrospectively identified in our clinical records and matched to tricuspid aortic valve (TAV) controls by age, gender, and presentation with TAD. Subjects with prior ascending aortic intervention were excluded. Measurements included aortic arch tortuosity, length, angle, width and height. Total aortic tortuosity was estimated in subjects with available abdominal images.Results120 BAV and 234 TAV subjects were included. Our 2D measurements were highly correlated with 3D midline arch measurements and had high inter- and intra-observer reliability. Compared to TAV, BAV subjects had increased arch tortuosity (median 1.76 [Q1-Q3: 1.62-1.95] vs. 1.63 [1.53-1.78], P < 0.01), length (149 [136-160] vs. 135 [122-152] mm, P < 0.01), height (46 [41-53] vs. 39 [34-47] mm, P < 0.01), and vertex acuity (70 [61-77] vs. 75 [68-81] degree, P < 0.01). In a multivariable analysis, arch tortuosity remained independently associated with BAV after adjusting for aortic diameter and other clinical characteristics.ConclusionsWe found that aortic arch tortuosity is significantly increased in BAV and may identify BAV patients who are at increased risk for TAD. Further studies to evaluate the association between tortuosity and clinical outcomes are in progress.
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Project description:More than half of patients with severe aortic stenosis (AS) over 70 years old have coronary artery disease (CAD). Exertional angina is often present in AS-patients, even in the absence of significant CAD, as a result of oxygen supply/demand mismatch and exercise-induced myocardial ischemia. Moreover, persistent myocardial ischemia leads to extensive myocardial fibrosis and subsequent coronary microvascular dysfunction (CMD) which is defined as reduced coronary vasodilatory capacity below ischemic threshold. Therefore, angina, as well as noninvasive stress tests, have a low specificity and positive predictive value (PPV) for the assessment of epicardial coronary stenosis severity in AS-patients. Moreover, in symptomatic patients with severe AS exercise testing is even contraindicated. Given the limitations of noninvasive stress tests, coronary angiography remains the standard examination for determining the presence and severity of CAD in AS-patients, although angiography alone has poor accuracy in the evaluation of its functional severity. To overcome this limitation, the well-established invasive indices for the assessment of coronary stenosis severity, such as fractional flow reserve (FFR) and instantaneous wave-free ratio (iFR), are now in focus, especially in the contemporary era with the rapid increment of transcatheter aortic valve replacement (TAVR) for the treatment of AS-patients. TAVR induces an immediate decrease in hyperemic microcirculatory resistance and a concomitant increase in hyperemic flow velocity, whereas resting coronary hemodynamics remain unaltered. These findings suggest that FFR may underestimate coronary stenosis severity in AS-patients, whereas iFR as the non-hyperemic index is independent of the AS severity. However, because resting coronary hemodynamics do not improve immediately after TAVR, the coronary vasodilatory capacity in AS-patients treated by TAVR remain impaired, and thus the iFR may overestimate coronary stenosis severity in these patients. The optimal method for evaluating myocardial ischemia in patients with AS and co-existing CAD has not yet been fully established, and this important issue is under further investigation. This review is focused on challenges, limitations, and future perspectives in the functional assessment of coronary stenosis severity in these patients, bearing in mind the complexity of coronary physiology in the presence of this valvular heart disease.
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