No abstract

Background Persistent patent foramen ovale (PFO) and patent ductus arteriosus (PDA) increase the adult risk of cryptogenic embolic stroke and chronic pulmonary hypertension. To understand the characteristics of PFO and PDA in newborns, we investigated the spontaneous closure rate and derived the determinants for residual defects. Methods We utilized the database of congenital heart disease (CHD) in Xiamen ChangGung Memorial Hospital from 2015 to 2017 and allocated 2523 eligible newborns into four groups according to PDA, PFO, both or neither at birth. A total of 574, 1229, 202 and 518 newborns were assigned into the group of PFO and PDA, PFO alone, PDA alone and non-PFO/non-PDA, respectively. Regular echocardiographic follow-ups at baseline, 6, 12 and 24 months after birth were performed for evaluating the spontaneous closure rate in the subjects. Regression analysis was carried out to study the risk factors of residual congenital defects. Results Newborns with PFO alone had the youngest birth age and lowest birth weight among the four groups. About one in four PDA-alone newborns had concomitant small ASD, i.e., <5 mm in diameter. Echocardiographic study showed that 71.3% and 30.8% of CHD newborns had PFO and PDA, respectively, compared to less than 10% of them having ASD or VSD. However, more than 95% of newborns with PFO or PDA closed spontaneously at 6 months, in contrast to about 30% of newborns with ASD or VSD had persistent existence of the intracardiac defects. Complex CHD significantly linked to persistent PFO or PDA at 6 and 12 months, with an adjusted hazard ratio of 9.03 (95% CI 1.97–41.46) and 12.11 (95% CI 2.11–69.72), respectively. Conclusions Chinese newborns with PFO or PDA expressed differences in characteristics and concomitant congenital defects. Additionally, persistent PFO or PDA is strongly associated with complex CHD and requires long-term regular monitoring for future associated complications.

the costs and effects of treatment with IDegAsp twice daily versus BIAsp 30 twice daily over a 2-year period, from the perspective of Chinese healthcare payers. The clinical data required for the model were obtained from a phase III treat-to-target clinical trial in China (NCT02762578), including insulin dosing, hypoglycemia rates, and reduced body mass index (BMI). Costs including treatment cost and hypoglycemic cost and event-related disutility data were derived from published sources. The insulin prices were the averaged drug provincial biding prices until December 2019 in china. One-way and probabilistic sensitivity analyses were performed. No discounting was applied for such a short time horizon. Results: Compared with BIAsp 30, treatment with IDegAsp was associated with an improvement of 0.0252 (1.5388 vs. 1.5137) quality-adjusted life years (QALYs) over a 2-year time horizon, driven by lower rates of hypoglycemic events, and less additional self-measured blood glucose (SMBG) test for hypoglycemic events. IDegAsp saved 289 CNY for total cost than BIAsp 30 (38,803 vs. 39,092). Cost savings were primarily driven by lower hypoglycemic cost (8,409 CNY, 6,738 vs. 15,147), which offset the higher insulin costs (8,120 CNY, 20,816 vs. 12,696) relative to BIAsp 30. Results were robust across a range of sensitivity analyses. Conclusions: This short-term cost-effectiveness model showed that, compared with BIAsp 30, IDegAsp resulted in a gain of QALYs and savings in costs, and was a dominant treatment option for people with T2DM in China.