Rationale and design of the SPRING trail: effectivity and safety of Pfo closuRe vs medIcine in alleviatiNg migraine, a multicenter, randomized and open-label trail.

BACKGROUND: Migraine is a leading cause of disability worldwide. Several retrospective studies have suggested that the closure of the Patent Foramen Ovale (PFO) may provide relief from migraines. However, three randomized controlled trials did not meet their primary endpoints regarding migraine cessation, reduction in monthly migraine days, and responder rates. METHODS: The SPRING study is a multicenter, prospective, randomized, and open-label trial designed to compare the effectiveness and safety of PFO closure versus medication in the relief of migraines. The primary endpoint is the total cessation of migraines, as recorded in patient headache diaries during the follow-up period. Additional diagnostic tools include echocardiography with agitated saline contrast, transcranial Doppler, and routine laboratory measurements. CONCLUSION: The SPRING trial aims to assess the effectiveness and safety of PFO closure versus medication in mitigating migraines in real-world settings. (Clinical Trails ID: NCT04946734).

ACE2 gene polymorphisms are associated with elevated pulmonary artery pressure in congenital heart diseases.

BACKGROUNDS: Angiotensin converting enzyme 2 (ACE2) polymorphisms are related to the occurrence and prognosis of cardiovascular disease. However, whether ACE2 polymorphisms also affect pulmonary circulation in congenital heart disease (CHD) remains unclear. Thus, we investigated the relationship between ACE2 single nucleotide polymorphism (SNPs) and pulmonary circulation in CHD patients of Chinese Han ethnicity. METHODS: Enrolled CHD patients (n = 367) underwent gene sequencing of ACE2 SNPs rs2074192, rs2285666, and rs2106809. Patients with pulmonary hypertension were further examined for detailed hemodynamics. RESULTS: Female heterozygous patients had worse pulmonary circulation hemodynamic parameters compared to those of homozygotes. Female CHD patients with the CCA (OR = 0.53, 95% CI: 0.32-0.88) or CCG (OR = 0.59, 95% CI: 0.35-0.99) haplotype had a lower risk of elevated pulmonary artery pressure. CONCLUSION: In female CHD patients, ACE2 SNPs are related to pulmonary circulation hemodynamics. Female CHD patients with the CCA and CCG haplotype had a lower risk of pulmonary hypertension.

Model for screening adult congenital heart disease surgery eligibility with echocardiography parameters.

OBJECTIVES: This study aimed to screen for the eligibility of correction in cases of adult congenital heart disease (CHD). Pulmonary to systemic flow ratios (Qp/Qs) > 1.5 and pulmonary to systemic vascular resistance ratios (Rp/Rs) < 1/3, acquired by right heart catheterization (RHC), are two essential parameters. Nonetheless, performing RHC at every follow-up is impractical and even harmful. Thus, it is important to establish a model to predict Qp/Qs and Rp/Rs status before a RHC confirmation, using echocardiography parameters. METHODS: A total of 1,785 patients with adult CHD were enrolled and randomly assigned to the derivation or validation groups. Echocardiogram parameters of the 974 patients in the derivation group were considered candidate predictors for surgery eligibility (Qp/Qs > 1.5 and Rp/Rs < 1/3). Binary logistic regression analyses were performed to identify the independent predictors and establish a scoring system. The scoring system was further examined in the validation group using a receiver operating characteristic (ROC) analysis. RESULTS: Estimated pulmonary artery systolic pressure, velocity through the pulmonary valve, and diameters of the left and right atria were identified as independent predictors. The area under the ROC curve of the predictive value in the validation group and its pre- and post-tricuspid valve malformation subgroups were 0.87 (95% confidence interval [CI]: 0.84-0.90, p < 0.01), 0.86 (95% CI: 0.82-0.91, p < 0.01), and 0.85 (95% CI: 0.79-0.90, p < 0.01), respectively. CONCLUSIONS: This scoring system could augment flexibility and convenience for pre-screening CHD patients' eligibility for surgery, before RHC.

Carcinoembryonic antigen levels are increased with pulmonary output in pulmonary hypertension due to congenital heart disease.

OBJECTIVE: Pulmonary artery hypertension (PAH) is a severe complication of congenital heart disease (CHD). Monitoring of pulmonary arterial pressure (PAP) and pulmonary vascular resistance (PVR) is essential during follow-up. This retrospective study aimed to examine carcinoembryonic antigen (CEA) as an additional marker for evaluation by investigating the correlation between CEA levels and hemodynamics in CHD-PAH. METHODS: Seventy-six patients with CHD-PAH (mean PAP [mPAP] >25 mmHg and PVR >3 Wood units, group A), 71 patients with CHD and pulmonary hypertension (CHD-PH, mPAP >25 mmHg and PVR ≤3 Wood units, group B), and 102 patients with CHD without PH (mPAP ≤25 mmHg, group C) were enrolled. Serum CEA levels and the relationships between CEA levels and hemodynamic data were assessed. RESULTS: Mean serum CEA levels were 1.99±1.61, 2.44±1.82, and 1.58±1.07 ng/mL, mPAP was 58.66±20.21, 30.2±4.83, and 17.31±4.51 mmHg, and PVR was 10.12±7.01, 2.19±0.56, and 2.2±1.1 Wood units in groups A, B, and C, respectively. Mean pulmonary output (PO) was 7.24±3.07, 15.79±5.49, 10.18±4.72 L/minute, respectively. CEA levels were positively correlated with PO and negatively correlated with PVR in all of the patients. CONCLUSION: CEA levels are increased with PO and decreased with PVR in CHD-PH.