Humans ; Cardiac Catheterization ; Treatment Outcome ; Heart Septal Defects, Atrial/surgery* ; Cerebral Infarction ; Septal Occluder Device

Objective: To recognize the potential factors that contribute to the eradication of migraine headache in patients with patent foramen ovale (PFO) at one year after percutaneous closure. Methods: A prospective cohort study was conducted, which enrolled patients diagnosed with migraines and PFO at the Department of Structural Heart Disease, First Affiliated Hospital of Xi'an Jiaotong University between May 2016 and May 2018. The patients were segregated into two groups based on their response to treatment, and one group showed elimination of migraines while another did not. Elimination of migraines was defined as a Migraine Disability Assessment Score (MIDAS) score of 0 at one year postoperatively. Least Absolute Shrinkage and Selection Operator (LASSO) regression model was utilized to identify the predictive variables for migraine elimination post-PFO closure. Multiple logistic regression analysis was employed to determine the independent predictive factors. Results: The study enrolled a total of 247 patients, with an average age of (37.5±13.6) years, comprising 81 male individuals (32.8%). One year after closure, 148 patients (59.9%) reported eradication of their migraines. Multivariate logistic regression analysis revealed that migraine with or without aura (OR=0.003 9, 95%CI 0.000 2-0.058 7, P=0.000 18), a history of antiplatelet medication use (OR=0.088 2, 95%CI 0.013 7-0.319 3, P=0.001 48) and resting right-to-left shunt (RLS) (OR=6.883 6, 95%CI 3.769 2-13.548 0, P<0.001) were identified as independent predictive factors for elimination of migraine. Conclusion: Migraine with or without aura, a history of antiplatelet medication use, and resting RLS are the independent prognostic factors associated with elimination of migraine. These results provide important clues for clinicians to choose the optimal treatment plan for PFO patients. However, further studies are needed to confirm these findings.
Humans ; Male ; Young Adult ; Adult ; Middle Aged ; Foramen Ovale, Patent/surgery* ; Prospective Studies ; Heart Diseases ; Hospitals ; Migraine Disorders/surgery*

Atrial Fibrillation/surgery* ; Catheter Ablation/adverse effects* ; Heart Septal Defects, Atrial/surgery* ; Humans ; Iatrogenic Disease ; Treatment Outcome

Objective: To explore the short-term efficacy of fenestrated atrial septal defect (ASD) occulders in the treatment of pulmonary arterial hypertension (PAH). Methods: Thirty-six healthy dogs were divided into the balloon atrial septostomy (BAS)+fenestrated ASD occulders group (n=12), BAS group (n=12) and non-septostomy group (n=12). PAH was induced by intra-atrial injection of dehydrogenized monocrotaline (1.5 mg/kg) in all dogs. Animals in the BAS+fenestrated ASD occulders group underwent atrial septal puncture and fenestrated ASD occulders implantation. Animals in the BAS group underwent balloon atrial septostomy. The non-septostomy group received no surgical intervention. The hemodynamic indexes and blood N-terminal pro-B-type natriuretic peptide (NT-proBNP) of dogs were measured before modeling, 2 months after modeling, 1, 3, and 6 months after surgery, respectively. Echocardiography was performed to observe the patency of the shunt and atrial septostomy of the dogs in the BAS+fenestrated ASD occulders group and BAS group at 1, 3, and 6 months after surgery. Three dogs were sacrificed in each group at 1, 3, and 6 months after surgery, respectively. Atrial septal tissue and fenestrated ASD occulders were removed to observe the patency and endothelialization of the device. Lung tissues were obtained for hematoxylin-eosin (HE) staining to observe the inflammatory cells infiltration and the thickening and narrowing of the pulmonary arterials. Results: Among 36 dogs, 2 dogs died within 24 hours after modeling, and 34 dogs were assigned to BAS+fenestrated ASD occulders group (n=12), BAS group (n=11), and non-septostomy group (n=11). Compared with BAS group, the average right atrial pressure (mRAP) and NT-proBNP of dogs in the BAS+fenestrated ASD occulders group were significantly reduced at 3 months after surgery (P<0.05), and the cardiac output (CO) was significantly increased at 6 months after surgery, arterial oxygen saturation (SaO₂) was also significantly reduced (P<0.05). Compared with non-septostomy group, dogs in the BAS+fenestrated ASD occulders group had significantly lower mRAP and NT-proBNP at 1, 3, and 6 months after surgery (P<0.05), and higher CO and lower SaO₂ at 6 months after surgery (P<0.05). Compared with the non-septostomy group, the dogs in the BAS group had significantly lower mRAP and NT-proBNP at 1 month after surgery (P<0.05), and there was no significant difference on mRAP and NT-proBNP at 3 and 6 months after surgery (P>0.05). Echocardiography showed that there was a minimal right-to-left shunt in the atrial septum in the BAS group at 1 month after the surgery, and the ostomy was closed in all the dogs in the BAS group at 3 months after the surgery. There was still a clear right-to-left shunt in the dogs of BAS+fenestrated ASD occulders group. The shunt was well formed and satisfactory endothelialization was observed at 1, 3 and 6 months after surgery. The results of HE staining showed that the pulmonary arterials were significantly thickened, stenosis and collapse occurred in the non-septostomy group. Pulmonary microvascular stenosis and inflammatory cell infiltration in the pulmonary arterials were observed in the non-septostomy group. Pulmonary arterial histological results were comparable between BAS+fenestrated ASD occulders group and non-septostomy group at 6 months after surgery . Conclusions: The fenestrated ASD occulder has the advantage of maintaining the open fistula hole for a longer time compared with simple balloon dilation. The fenestrated ASD occulder can improve cardiac function, and it is safe and feasible to treat PAH in this animal model.
Animals ; Atrial Septum/surgery* ; Cardiac Catheterization/methods* ; Dogs ; Familial Primary Pulmonary Hypertension ; Heart Septal Defects, Atrial/surgery* ; Hypertension, Pulmonary ; Pulmonary Arterial Hypertension

Atrial Appendage/surgery* ; Foramen Ovale, Patent/surgery* ; Humans

Objective: To analyze the safety and efficacy of combined left atrial appendage (LAA) and patent foramen ovale (PFO) closure in adult atrial fibrillation (AF) patients complicating with PFO. Methods: This study is a retrospective and cross-sectional study. Seven patients with AF complicated with PFO diagnosed by transesophageal echocardiography (TEE) in Zhoupu Hospital Affiliated to Shanghai University of Medicine & Health Sciences from June 2017 to October 2020 were selected. Basic data such as age, gender and medical history were collected. The atrial septal defect or PFO occluder and LAA occluder were selected according to the size of PFO, the ostia width and depth of LAA. Four patients underwent left atrial appendage closure(LAAC) and PFO closure at the same time. PFO closure was performed during a one-stop procedure of cryoablation combined with LAAC in 2 patients. One patient underwent PFO closure at 10 weeks after one-stop procedure because of recurrent transient ischemic attack (TIA). All patients continued to take oral anticoagulants. TEE was repeated 8-12 weeks after intervention. In case of device related thrombus(DRT), TEE shall be rechecked 6 months after adjusting anticoagulant and antiplatelet drug treatment. Patients were follow-up at 1, 3, 6, 12, 24 months by telephone call, and the occurrence of cardio-cerebrovascular events was recorded. Results: Among the 7 patients with AF, 2 were male, aged (68.0±9.4) years, and 3 had a history of recurrent cerebral infarction and TIA. Average PFO diameter was (3.5±0.8)mm. Three patients were implanted with Watchman LAA occluder (30, 30, 33 mm) and atrial septal defect occluder (8, 9, 16 mm). 2 patients were implanted with LAmbre LAA occluder (34/38, 18/32 mm) and PFO occluder (PF1825, PF2525). 2 patients were implanted with LACbes LAA occluder (24, 28 mm) and PFO occluder (PF2525, PF1825) respectively. The patients were followed up for 12 (11, 24) months after operation. TEE reexamination showed that the position of LAA occluder and atrial septal defect occluder or PFO occluder was normal in all patients. DRT was detected in 1 patient, and anticoagulant therapy was adjusted in this patient. 6 months later, TEE showed that DRT disappeared. No cardiovascular and cerebrovascular events occurred in all patients with AF during follow-up. Conclusions: In AF patients complicated with PFO, LAAC combined with PFO closure may have good safety and effectiveness.
Adult ; Aged ; Atrial Appendage/surgery* ; Atrial Fibrillation/surgery* ; Cardiac Catheterization/methods* ; China ; Cross-Sectional Studies ; Foramen Ovale, Patent/surgery* ; Humans ; Male ; Middle Aged ; Retrospective Studies

Objective: To explore the risk factors for syncope in children with severe idiopathic pulmonary arterial hypertension (IPAH). Methods: Forty-four patients (age<18 years) with IPAH admitted to the Department of Pediatric Cardiology, Beijing Anzhen Hospital between May 2011 and October 2021 were retrospectively included. Patients were devided into syncope group and non-syncope group. Clinical manifestation and hemodynamic parameters including echocardiography, blood tests, right heart catheterization and acute pulmonary vascular expansion test were compared between two groups. Comparisons between groups were performed with unpaired Student t test, or Mann-Whitney U test or chi-square test. Logistic regression was used to calculate the odds ratio (OR) for parameters with statistically significant differences between groups and analyze the statistical correlation. Results: Among the 44 patients, 16 were males, the onset age was (7.2±3.9) years. Twenty-four (55%) children presented with 1 to 11 times of episodes of syncope, and 18 cases of whom induced by physical activity. Syncope group had a larger proportion of New York Heart Association (NYHA) heart function class Ⅲ-Ⅳ (67% (16/24) vs. 25% (5/20), χ²=7.59, P=0.006), higher brain natriuretic peptide (BNP) value ((251±39) vs. (61±40) pg/L, t=-2.18, P=0.035), higher pulmonary-to-aorta diameter ratio (1.6±0.4 vs. 1.4±0.2, t=-2.25, P=0.030) and larger pulmonary vascular resistance index ((22±11) vs. (16±7) WU/m², t=-2.13, P=0.039) compared with non-syncope group. The proportion of patent foramen ovale (4% (1/24) vs. 45% (9/20), χ²=10.36, P=0.001), left ventricular ejection fraction (LVEF) ((68±5)% vs. (72±8)%, t=2.23, P=0.031) and the positive rate of acute pulmonary vascular expansion test (8% (2/24) vs. 35% (7/20), χ²=4.77, P=0.029) of syncope group were significantly lower than those of non-syncope group. Multiple Logistic regression analysis showed that NYHA heart function Ⅲ-Ⅳ (OR=6.787, 95%CI 1.445-31.880), pulmonary vascular resistance index (OR=1.247, 95%CI 1.020-1.525) and BNP (OR=1.036, 95%CI 1.007-1.066) were independent risk factors for syncope. The patent foramen ovale (OR=0.010, 95%CI 0.000-0.586) was a protective factor for syncope. Conclusions: NYHA cardiac function grade, pulmonary vascular resistance index and BNP are independent risk factors for syncope. Patent foramen ovale is a protective factor for syncope. Exercise is the main inducement of syncope in children with IPAH.
Adolescent ; Child ; Child, Preschool ; Familial Primary Pulmonary Hypertension ; Female ; Foramen Ovale, Patent ; Humans ; Male ; Retrospective Studies ; Risk Factors ; Stroke Volume ; Syncope/etiology* ; Ventricular Function, Left

Objective: To investigate the dynamic change of the secundum atrial septal defect (ASD) throughout the cardiac cycle, and assess its impact on occluder selection. Methods: This study retrospectively analyzed 35 patients with ASD who received electrocardiogram-gated coronary CT angiography (CCTA) throughout the cardiac cycle as well as interventional closure therapy in Fuwai Hospital from December 2016 to December 2019. The raw data were reconstructed into 20 phasic images of RR intervals (RRI) ranging from 0 to 95% in an increment of 5% and transmitted to a workstation for postprocessing. For each phase image, CT virtual endoscopy reconstruction technique (CTVE) was used to provide views of ASD. Axial sequence assisted CT volumetric measurement (CTAS) was used to calculate the maximum dimensions in axial planes (D_a) and in superior-inferior direction (D_b). Using a formula for converting circumference to diameter, the equivalent circle dimensions were calculated (D_e, D_e=minor axis+2 (major axis-minor axis)/3). Taking the data of 75% RRI phase, the patients were divided into D_a75%RRI≥D_b75%RRI group and D_a75%RRIb75%RR group. According to the postoperative chest X-ray, the waist diameter of the occluder in the left anterior oblique plain film was measured, and its correction value (CR-POD_laoc) was calculated with the correction formula. Scatter plots of the changes of the mean values of D_a, D_b and D_e with the cardiac cycle were presented. The change and ratio of measured values of D_a and D_e at 35% and 75% RRI was calculated. The ratio of D_e change to D_a change in D_a75%RRI≥D_b75%RRI group and D_a75%RRIb75%RR group was calculated, respectively, and compared between groups. Pearson correlation analysis was used to explore the correlation between CR-POD_laoc and D_e35%RRI and D_e75%RRI. Results: A total of 35 patients, aged (42.7±15.0) years, including 10 males, were included. Among 35 patients, 8 cases were divided into group D_a75%RRI≥D_b75%RRI and 27 cases into group D_a75%RRIb75%RRI. Both D_a and D_b regularly changed at each phase throughout the cardiac cycle. The D_a changed significantly, with a maximum at phase of 35%-45% of RRI, and a minimum between phases of 90% and 0 of RRI. While the D_b showed insignificant changes during phases of 10%-90% RRI, and increased at 0-10% of RRI, then reduced in the remaining phases. The change of D_a was (6.35±2.46) mm, and the ratio of D_a values at 35% and 75% RRI was 0.77±0.08. The change of D_e was (2.28±1.32) mm, and the ratio of D_e at 35% and 75% RRI was 0.93±0.05. The ratio of D_e change to D_a change in the D_a75%RRI≥D_b75%RRI group was 0.67±0.13; while the ratio was 0.34±0.05 in D_a75%RRIb75%RR group, and there was significant difference between the two groups (P=0.02). CR-POD_laoc was positively correlated with D_{e35% RRI} (r=0.99, P<0.001) and D_{e75% RRI} (r=0.98, P<0.001). Conclusions: Most secundum ASDs show oval shape with D_b>D_a. D_b is basically constant while D_a changes significantly during cardiac cycle (10%-90% RRI). Nonetheless, both values peak and maintain the maximum status at end-systolic phase (35%-45% RRI). For patients with huge ASD, occluder selection should be based on the D_e at 35% RRI phase, which is helpful for the successful intervention.
Adult ; Cardiac-Gated Imaging Techniques ; Computed Tomography Angiography ; Coronary Angiography ; Electrocardiography/methods* ; Female ; Heart Septal Defects, Atrial/surgery* ; Humans ; Imaging, Three-Dimensional ; Male ; Middle Aged ; Retrospective Studies ; Septal Occluder Device

BACKGROUND: Nitinol-containing devices are widely used in clinical practice. However, there are concerns about nickel release after nitinol-containing device implantation. This study aimed to compare the efficacy and safety of a parylene-coated occluder vs. a traditional nitinol-containing device for atrial septal defect (ASD). METHODS: One-hundred-and-eight patients with ASD were prospectively enrolled and randomly assigned to either the trial group to receive a parylene-coated occluder (n = 54) or the control group to receive a traditional occluder (n = 54). The plugging success rate at 6 months after device implantation and the pre- and post-implantation serum nickel levels were compared between the two groups. A non-inferiority design was used to prove that the therapeutic effect of the parylene-coated device was non-inferior to that of the traditional device. The Cochran-Mantel-Haenszel chi-squared test with adjustment for central effects was used for the comparison between groups. RESULTS: At 6 months after implantation, successful ASD closure was achieved in 52 of 53 patients (98.11%) in both the trial and control groups (95% confidence interval (CI): [-4.90, 5.16]) based on per-protocol set analysis. The absolute value of the lower limit of the 95% CI was 4.90%, which was less than the specified non-inferiority margin of 8%. No deaths or severe complications occurred during 6 months of follow-up. The serum nickel levels were significantly increased at 2 weeks and reached the maximum value at 1 month after implantation in the control group (P < 0.05 vs. baseline). In the trial group, there was no significant difference in the serum nickel level before vs. after device implantation (P > 0.05). CONCLUSIONS The efficacy of a parylene-coated ASD occluder is non-inferior to that of a traditional uncoated ASD occluder. The parylene-coated occluder prevents nickel release after device implantation and may be an alternative for ASD, especially in patients with a nickel allergy.
Cardiac Catheterization ; Heart Septal Defects, Atrial/surgery* ; Humans ; Polymers ; Prospective Studies ; Prosthesis Design ; Septal Occluder Device/adverse effects* ; Treatment Outcome ; Xylenes

Cardiac Catheterization ; Foramen Ovale, Patent/diagnostic imaging* ; Humans ; Septal Occluder Device ; Stroke