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

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

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

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

Objective: To explore the feasibility and safety of intracardiac ultrasound-assisted atrial septal puncture (ASP) during radiofrequency ablation for atrial fibrillation. Methods: We enrolled 241 consecutive patients scheduled to radiofrequency ablation for atrial fibrillation in Beijing Anzhen Hospital from July to September 2020. Inclusion criteria: patients aged over 18 years with a clear electrocardiogram record of atrial fibrillation. Patients were divided into 2 groups: ASP with ultrasound-assisted X-ray (ultrasound group, n=123), ASP under X-ray alone (X-ray group, n=118). Clinical features of patients including age, sex, percent of paroxysmal atrial fibrillation, and repeat ablation, CHA₂DS₂-VASc score and past history (hypertension, diabetes mellitus, coronary artery disease, stroke/transient ischemic attack (TIA), valve diseases) and echocardiographic parameters (left atrial dimension, left ventricular ejection fraction, left ventricular end-diastolic dimension) were obtained and compared. The first-pass rate, radiation exposure time, duration of ASP, and complications of ASP were also compared between the two groups. Results: The age of patients in this cohort was (62.5±8.0) years, and the proportion of males was 57.0% (n=138). Among them, the proportion of paroxysmal atrial fibrillation was 56.0% (n=135), and the ratio of repeat ablation was 17.8% (n=43). Age, sex, percent of paroxysmal atrial fibrillation, history of hypertension, diabetes mellitus were similar between the two groups. The first-pass rate was significantly higher in the ultrasound group than in the X-ray group (94.3% (116/123) vs. 79.7% (94/118), P=0.001); the exposure time of X-ray was significantly shorter in the ultrasound group than in the X-ray group ((31.3±7.9) s vs. (124.8±35.7) s, P<0.001), while the duration of ASP was longer in the ultrasound group ((10.1±1.8) minutes vs. (8.2±1.3) minutes, P<0.001). In terms of complications, the incidence of puncture into the pericardium was lower in the ultrasound group (0 vs.3.4% (4/118), P=0.039); the rate of transient ST-segment elevation post ASP was similar between the ultrasound group and X-ray group (2.4% (3/123) vs. 1.7% (2/118), P=0.999). Conclusion: Intracardiac ultrasound-assisted atrial septal puncture can effectively improve the accuracy of atrial septal puncture, shorten the radiation exposure time, and reduce the complications related to atrial septal puncture.
Adult ; Aged ; Atrial Fibrillation/surgery* ; Catheter Ablation ; Feasibility Studies ; Heart Septal Defects, Atrial ; Humans ; Male ; Middle Aged ; Punctures ; Radiofrequency Ablation ; Stroke Volume ; Ventricular Function, Left

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

Unroofed coronary sinus syndrome (UCSS), also named coronary sinus septal defect, is a rare type of atrial septal defect with the incidence less than 1% of the total number of atrial septal defects. It is caused by incomplete formation of left atrial venous folds during embryonic development. Here we reported a patient with UCSS, who was treated in the Second Xiangya Hospital of Central South University. The patient was 50 years old and the main clinical manifestations were fatigue and shortness of breath after repeated exercise. Color Doppler echocardiography showed coronary sinus dilatation (17 mm×14 mm), indicating the possibility of permanent left superior vena cava. Pulmonary angiography showed that the left ventricle and coronary sinus were developed at the same time while the atrial septum was intact after the development of the left atrium, followed by the right atrium and right ventricle, indicating a partial anomalous pulmonary venous drainage (intracardiac type). Finally, the cardiac computed tomograhic angiography showed that 4 pulmonary veins and permanent left superior vena cava (PLSVC) went into the left atrium and the coronary sinus, respectively, while the coronary sinus septum was absent and the PLSVC was connected with the left atrium. The patient was later treated with the correction of non-parietal sinus syndrome in the Cardiovascular Surgery Department of our hospital.
Coronary Sinus ; Heart Atria ; Heart Septal Defects, Atrial ; Humans ; Middle Aged ; Vena Cava, Superior

Objective: To explore whether the atrial septal defect(ASD) size, the type of occlusion umbrella selected, and the morphological changes after release of occlusion umbrella affect the headache symptoms of ASD patients after operation. Methods: A total of 567 ASD ptients, who underwent successful implantion with a single occlude from January 2014 to December 2017 in General Hospital of Northern Theater Command were enrolled. The patients were divided into symptomatic group and asymptomatic group according to the presence or absence of headache symptoms after occlusion. X-ray catheter calibration method was used to measure the diameter(d), thickness（L）, maximum diameter of the left umbrella surface after release(D2) and the value of i (i = D2/L). Risk factors related to headache were analyzed by multivariate logistic regression analysis. linear regression analysis was used to detect the relationship between the type of occluder umbrella and ASD diameter in asymptomatic group. Results: A total of 567 patients with one occluder umbrella were included, and 148(26.1%) cases were male. The age was (34.4±19.4) years old. The follow-up time was (12.7±2.8) months. There were 51 cases in the symptomatic group and 516 cases in the asymptomatic group. In 29 patients who were treated by extending the course or increasing the dose of aspirin, the symptoms disappeared or improved. There was no significant difference in the maximum ASD diameter (TTE measured) and the size of occluder between the symptomatic group and asymptomatic group(both P>0.05). The value of d ((19.80±6.67)mm vs.(17.40±7.28) mm, P=0.041) D2 ((43.29±7.41）mm vs. (39.20±9.59)mm， P=0.013)and L((13.06±3.72)mm vs. (10.19±2.90) mm，P=0.025) of the symptomatic group were all higher than that of the asymptomatic group，while the i value was smaller((3.54±0.88）vs.(3.99±0.93)，P=0.010）. The results of multivariate logistic regression analysis showed that the value of L(OR=1.286，95%CI 1.176-1.406, P=0.002) and the value of i(OR=0.916，95%CI 0.867-0.968, P<0.001) were independent factors of headache symptoms in patients after ASD occlusion, while the value of d and the value of D2 were not independent factors (both P>0.05). Linear equations obtained from asymptomatic patients showed the size of occluder =1.121×the maximum ASD diameter of TTE measured +6.414. Conclusions: There is no correlation between the symptoms with the expanded diameter and the maximum diameter of left umbrella's surface after released. The Postoperative discomfort symptoms is significantly correlated to the thickness of the occluder and the value of i. It is suggested that headache could be induced by the oversized occlude, thus choosing the appropriate size of the occluder is essential to reduce the occurrence of postoperative headache symptoms. Increasing the size of occluder because of worrying about the abscission and removal of the occlude is unreasonable. The antiplatelet therapy should also be strengthened to reduce the occurrence of symptoms and improve the symptoms of the patients if the occluder's size is too large. This regression equation (The size of occluder =1.121 × the maximum ASD diameter of TTE measured +6.414) could be used as a reference for the suitable selection of ASD occluder.
Adolescent ; Adult ; Cardiac Catheterization ; Echocardiography, Transesophageal ; Headache ; Heart Septal Defects, Atrial ; Humans ; Male ; Middle Aged ; Postoperative Period ; Septal Occluder Device ; Treatment Outcome ; Young Adult

Heart Septal Defects, Atrial/diagnostic imaging* ; Humans ; Liver ; Vena Cava, Inferior ; Vena Cava, Superior

Atrial Fibrillation ; pathology ; Heart Defects, Congenital ; pathology ; Heart Septal Defects, Atrial ; pathology ; Humans ; Male ; Middle Aged ; Pulmonary Veins ; pathology ; Vena Cava, Superior ; pathology