Pregnant Women Following Bariatric Surgery: a Focus on Maternal Mental Health and Its Impact on Birth Outcomes.

PURPOSE: Bariatric surgery is associated with elevated risks for adverse birth outcomes, such as small-for-gestational-age infants (SGA). Maternal mental health is a critical regulator of fetal growth, but it is largely overlooked in pregnant women post-surgery. This study aimed to examine the associations between maternal mental health and birth outcomes in pregnant women post-bariatric surgery. MATERIALS AND METHODS: This was a retrospective analysis of medical records of women who had a singleton delivery following Roux-en-Y gastric bypass or sleeve gastrectomy. Mental health measures included depression/anxiety and substance use (cigarettes, alcohol, opioids, and marijuana). Birth outcomes were fetal growth restriction, SGA, low birthweight, and preterm birth. Logistic regressions were used to assess the associations between maternal mental health and each of the birth outcomes. A post hoc logistic regression was conducted to assess factors that influenced maternal marijuana use. RESULTS: Participants (N = 179) were mostly white (64.6%), non-Hispanic (84.5%), with a mean age of 32.7 ± 4.6 years, and mean body mass index of 37.2 ± 8.4 kg/m2 at conception. Maternal marijuana use significantly increased the odds for fetal growth restriction, SGA, low birthweight, and preterm birth. Cigarette use increased the risk for low birthweight. Conversely, alcohol use was protective of low birthweight and preterm birth. A post hoc analysis revealed that married women were less likely to use marijuana than those who were single, divorced, or widowed. CONCLUSION: This analysis identified marijuana and cigarette use as risk factors for adverse birth outcomes post-bariatric surgery. Future studies with larger sample sizes are needed to confirm study findings.

Multicentre, randomized comparison of two-stent and provisional stenting techniques in patients with complex coronary bifurcation lesions: the DEFINITION II trial.

AIM: The present study aimed to assess the benefits of two-stent techniques for patients with DEFINITION criteria-defined complex coronary bifurcation lesions. METHODS AND RESULTS: In total, 653 patients with complex bifurcation lesions at 49 international centres were randomly assigned to undergo the systematic two-stent technique (two-stent group) or provisional stenting (provisional group). The primary endpoint was the composite of target lesion failure (TLF) at the 1-year follow-up, including cardiac death, target vessel myocardial infarction (TVMI), and clinically driven target lesion revascularization (TLR). The safety endpoint was definite or probable stent thrombosis. At the 1-year follow-up, TLF occurred in 37 (11.4%) and 20 (6.1%) patients in the provisional and two-stent groups, respectively [77.8%: double-kissing crush; hazard ratio (HR) 0.52, 95% confidence interval (CI) 0.30-0.90; P = 0.019], largely driven by increased TVMI (7.1%, HR 0.43, 95% CI 0.20-0.90; P = 0.025) and clinically driven TLR (5.5%, HR 0.43, 95% CI 0.19-1.00; P = 0.049) in the provisional group. At the 1 year after indexed procedures, the incidence of cardiac death was 2.5% in the provisional group, non-significant to 2.1% in the two-stent group (HR 0.86, 95% CI 0.31-2.37; P = 0.772). CONCLUSION: For DEFINITION criteria-defined complex coronary bifurcation lesions, the systematic two-stent approach was associated with a significant improvement in clinical outcomes compared with the provisional stenting approach. Further study is urgently warranted to identify the mechanisms contributing to the increased rate of TVMI after provisional stenting. STUDY REGISTRATION: http://www.clinicaltrials.com; Identifier: NCT02284750.

Treatment effects of systematic two-stent and provisional stenting techniques in patients with complex coronary bifurcation lesions: rationale and design of a prospective, randomised and multicentre DEFINITION II trial.

INTRODUCTION: Provisional stenting (PS) for simple coronary bifurcation lesions is the mainstay of treatment. A systematic two-stent approach is widely used for complex bifurcation lesions (CBLs). However, a randomised comparison of PS and two-stent techniques for CBLs has never been studied. Accordingly, the present study is designed to elucidate the benefits of two-stent treatment over PS in patients with CBLs. METHODS AND ANALYSIS: This DEFINITION II study is a prospective, multinational, randomised, endpoint-driven trial to compare the benefits of the two-stent technique with PS for CBLs. A total of 660 patients with CBLs will be randomised in a 1:1 fashion to receive either PS or the two-stent technique. The primary endpoint is the rate of 12-month target lesion failure defined as the composite of cardiac death, target vessel myocardial infarction (MI) and clinically driven target lesion revascularisation. The major secondary endpoints include all causes of death, MI, target vessel revascularisation, in-stent restenosis, stroke and each individual component of the primary endpoints. The safety endpoint is the occurrence of definite or probable stent thrombosis. ETHICS AND DISSEMINATION: The study protocol and informed consent have been approved by the Institutional Review Board of Nanjing First Hospital, and accepted by each participating centre. Written informed consent was obtained from all enrolled patients. Findings of the study will be published in a peer-reviewed journal and disseminated at conferences. TRIAL REGISTRATION NUMBER: NCT02284750; Pre-results.