Preliminary findings on the use of intravascular ultrasound in the assessment of pediatric pulmonary vein stenosis.

OBJECTIVE: Determine the feasibility of performing intravascular ultrasound (IVUS) in pediatric pulmonary vein stenosis (PVS) and investigate whether IVUS can delineate the mechanism of PVS. BACKGROUND: The use of IVUS in pediatric patients with PVS has not been reported. METHODS: Retrospective, single center, cohort analysis of all patients who underwent IVUS of pulmonary veins from August 2016 to December 2019. RESULTS: IVUS was performed on 81 pulmonary veins in 50 pediatric patients (median age = 1.7 years [0.9, 3.1], median weight = 8.6 kg [7.3, 11.8]). All veins accepted the IVUS catheter (.014 or .018), with adequate visualization in 88% (71/81) of imaged veins, and improvement in visualization in the more recent period (23/24; 96%). Veins were categorized as having presumed intimal thickening (PIT) with luminal narrowing (n = 36), ostial narrowing without PIT (n = 14), distortion/compression (n = 6), normal (n = 2), and stent with (n = 9) or without in-stent stenosis (n = 4). In veins with at least 6 months of follow up, (re)intervention occurred more commonly in veins with PIT (14/19; 74%) versus veins without PIT (3/13; 23%; p = 0.01). There were no IVUS related adverse events. CONCLUSION: IVUS can be used safely in pediatric patients and can reliably demonstrate vein lumen and wall architecture. With further refinement, IVUS has the potential to differentiate intimal neo-proliferation from other mechanisms of obstruction. The exact role of IVUS in the assessment of pediatric PVS is yet to be determined.

Fetal Aortic Valvuloplasty for Evolving Hypoplastic Left Heart Syndrome: A Decision Analysis.

BACKGROUND: Fetal aortic valvuloplasty (FAV) may prevent progression of midgestation aortic stenosis to hypoplastic left heart syndrome. However, FAV has well-established risks, and its survival benefit remains unknown. Our primary aim was to determine whether FAV for midgestation aortic stenosis increases survival from fetal diagnosis to age 6 years. METHODS AND RESULTS: We performed a retrospective analysis of 143 fetuses who underwent FAV from 2000 to 2017 and a secondary analysis of the Pediatric Heart Network Single Ventricle Reconstruction trial. Using these results, we developed a decision model to estimate probability of transplant-free survival from fetal diagnosis to age 6 years and postnatal restricted mean transplant-free survival time. FAV was technically successful in 84% of 143 fetuses with fetal demise in 8%. Biventricular circulation was achieved in 50% of 111 live-born infants with successful FAV but in only 16% of the 19 patients with unsuccessful FAV. The model projected overlapping probabilities of transplant-free survival to age 6 years at 75% (95% CI, 67%-82%) with FAV versus 72% (95% CI, 61%-82%) with expectant fetal management, resulting in a restricted mean transplant-free survival time benefit of 1.2 months. When limiting analyses to the improved FAV experience since 2009 to reflect current practice, (probability of technical success [94%], fetal demise [4%], and biventricular circulation [66%]), the model projected that FAV increased the probability of survival to age 6 years to 82% (95% CI, 73%-89%). Expectant management is favored if risk of fetal demise exceeded 12% or probability of biventricular circulation fell below 26%, but FAV remained favored over plausible recent range of technical success. CONCLUSIONS: Our model suggests that FAV provides a modest, medium-term survival benefit over expectant fetal management. Appropriate patient selection and low risk of fetal demise with FAV are critical factors for obtaining a survival benefit.

A Patient-Centered Framework for Evaluating Digital Maturity of Health Services: A Systematic Review.

BACKGROUND: Digital maturity is the extent to which digital technologies are used as enablers to deliver a high-quality health service. Extensive literature exists about how to assess the components of digital maturity, but it has not been used to design a comprehensive framework for evaluation. Consequently, the measurement systems that do exist are limited to evaluating digital programs within one service or care setting, meaning that digital maturity evaluation is not accounting for the needs of patients across their care pathways. OBJECTIVE: The objective of our study was to identify the best methods and metrics for evaluating digital maturity and to create a novel, evidence-based tool for evaluating digital maturity across patient care pathways. METHODS: We systematically reviewed the literature to find the best methods and metrics for evaluating digital maturity. We searched the PubMed database for all papers relevant to digital maturity evaluation. Papers were selected if they provided insight into how to appraise digital systems within the health service and if they indicated the factors that constitute or facilitate digital maturity. Papers were analyzed to identify methodology for evaluating digital maturity and indicators of digitally mature systems. We then used the resulting information about methodology to design an evaluation framework. Following that, the indicators of digital maturity were extracted and grouped into increasing levels of maturity and operationalized as metrics within the evaluation framework. RESULTS: We identified 28 papers as relevant to evaluating digital maturity, from which we derived 5 themes. The first theme concerned general evaluation methodology for constructing the framework (7 papers). The following 4 themes were the increasing levels of digital maturity: resources and ability (6 papers), usage (7 papers), interoperability (3 papers), and impact (5 papers). The framework includes metrics for each of these levels at each stage of the typical patient care pathway. CONCLUSIONS: The framework uses a patient-centric model that departs from traditional service-specific measurements and allows for novel insights into how digital programs benefit patients across the health system. TRIAL REGISTRATION: N/A.

Five Policy Levers To Meet The Value Challenge In Cancer Care.

The burden of cancer on public finances is a serious concern for policy makers. More people are developing cancer, and as standards of care have risen, more are surviving and requiring longer-term care. Precision medicine promises better outcomes but demands commensurately higher payments for care. As both incidence and per case costs rise, we suggest that the task of expanding access to high-quality cancer care poses a "value challenge" that policies in many countries are inadequate to meet. Policy makers should respond with a new approach. We explore questions that policy makers will need to consider regarding objectives, barriers, and levers for policy development. We use transparency and accountability as cornerstones of a new approach to promote value-based decision making. Although barriers to advancing this agenda are formidable, we recommend that governments define common standards for value-based accounting; serve as information brokers for evidence development; pioneer value-based procurement of goods and services; engage in deliberative democracy in cancer care; and educate communities to facilitate knowledge sharing between communities of patients, their caretakers, and researchers.