In this paper, a preliminary stress/strain analysis of the design structure of a nickel-titanium alloy patent foramen ovale occluder is conducted with the finite element simulation analysis method. In the analysis, solid structure modeling is carried out on three different specifications of domestic patent foramen ovale occluders. Referring to the test method of fatigue performance in inspection standard YY/T 1553-2017, an initial installation deformation is applied to the model, and then the fatigue displacement of 2 mm is applied to the sample to make the model fatigue deformation. The fatigue safety factors of each type of occluder are obtained by strain simulation analysis. The results indicate that the minimum fatigue safety factors of the three specifications of domestic patent foramen ovale occluders are 2.09, 2.35 and 2.06 respectively, which all meet the design of fatigue safety factor greater than 1. Among them, 1818 and 3030 specifications of patent foramen ovale occluders have close values in minimum fatigue safety factors, and both are lower than that of 1825 model. Therefore, it is recommended to carry out physical fatigue tests on both 1818 and 3030 specifications to further verify the fatigue performance of the products.
Finite Element Analysis ; Titanium ; Nickel ; Alloys ; Foramen Ovale, Patent ; Materials Testing ; Septal Occluder Device ; Stress, Mechanical

Pediatric vertigo presents with complex etiologies, and its clinical diagnosis and management can be challenging due to children's limited ability to describe their symptoms. Recurrent vertigo episodes in children, who are at a critical stage of development, can readily lead to emotional disorders in both the children themselves and their guardians. This article reports a case of benign paroxysmal vertigo of childhood（BPVC） in a child who sought care from multiple providers. The child was found to have a patent foramen ovale（PFO） and mild emotional disorder. By analyzing challenges encountered during the diagnostic and management process in this case of recurrent pediatric vertigo, this study provides practical guidance for rational selection of diagnostic techniques and the comprehensive assessment of disease status in pediatric vertigo/dizziness.
Child ; Humans ; Affective Symptoms/complications* ; Foramen Ovale, Patent/complications* ; Vertigo/complications*

Humans ; Pulmonary Atresia/therapy* ; Pregnancy ; Female ; China ; Consensus ; Fetal Heart ; Ultrasonography, Prenatal ; Heart Defects, Congenital/therapy* ; Ventricular Septum ; Cardiac Surgical Procedures/methods*

Objective: Explore the relationship between tip of the left bundle branch pacing lead and anatomic location of left bundle branch as well as the mechanism of left bundle branch current of injury. To clarify the clinical value of left bundle branch current of injury during operation. Methods: The pacing leads were implanted in the hearts of two living swines. Intraoperative electrophysiological study confirmed that the left bundle branch or only the deep left ventricular septum was captured at low output. Immediately after operation, the gross specimen of swine hearts was stained with iodine to observe the gross distribution of His-purkinje conduction system on the left ventricular endocardium and its relationship with the leads. Subsequently, the swine hearts were fixed with formalin solution, and the pacing leads were removed after the positions were marked. The swine hearts were then sectioned and stained with Masson and Goldner trichrome, and the relationship between the anatomic location of the conduction system and the tip of the lead was observed under a light microscope. Results: After iodine staining of the specimen, the His-purkinje conduction system was observed with the naked eye in a net-like distribution, and the lead tip was screwed deeply and fixed in the left bundle branch area of the left ventricular subendocardium in the ventricular septum. Masson and Goldner trichrome staining showed that left bundle branch pacing lead directly passed through the left bundle branch when there was left bundle branch potential with left bundle branch current of injury, while it was not directly contact the left bundle branch when there was left bundle branch potential without left bundle branch current of injury. Conclusion: The left bundle branch current of injury observed on intracardiac electrocardiogram during His-purkinje conduction system pacing suggests that the pacing lead directly contacted the conduction bundle or its branches, therefore, the captured threshold was relatively low. Left bundle branch current of injury can be used as an important anatomic and electrophysiological evidence of left bundle branch capture.
Animals ; Swine ; Bundle of His/physiology* ; Ventricular Septum ; Cardiac Pacing, Artificial ; Heart Conduction System ; Electrocardiography ; Iodine

Objective: Explore the relationship between tip of the left bundle branch pacing lead and anatomic location of left bundle branch as well as the mechanism of left bundle branch current of injury. To clarify the clinical value of left bundle branch current of injury during operation. Methods: The pacing leads were implanted in the hearts of two living swines. Intraoperative electrophysiological study confirmed that the left bundle branch or only the deep left ventricular septum was captured at low output. Immediately after operation, the gross specimen of swine hearts was stained with iodine to observe the gross distribution of His-purkinje conduction system on the left ventricular endocardium and its relationship with the leads. Subsequently, the swine hearts were fixed with formalin solution, and the pacing leads were removed after the positions were marked. The swine hearts were then sectioned and stained with Masson and Goldner trichrome, and the relationship between the anatomic location of the conduction system and the tip of the lead was observed under a light microscope. Results: After iodine staining of the specimen, the His-purkinje conduction system was observed with the naked eye in a net-like distribution, and the lead tip was screwed deeply and fixed in the left bundle branch area of the left ventricular subendocardium in the ventricular septum. Masson and Goldner trichrome staining showed that left bundle branch pacing lead directly passed through the left bundle branch when there was left bundle branch potential with left bundle branch current of injury, while it was not directly contact the left bundle branch when there was left bundle branch potential without left bundle branch current of injury. Conclusion: The left bundle branch current of injury observed on intracardiac electrocardiogram during His-purkinje conduction system pacing suggests that the pacing lead directly contacted the conduction bundle or its branches, therefore, the captured threshold was relatively low. Left bundle branch current of injury can be used as an important anatomic and electrophysiological evidence of left bundle branch capture.
Animals ; Swine ; Bundle of His/physiology* ; Ventricular Septum ; Cardiac Pacing, Artificial ; Heart Conduction System ; Electrocardiography ; Iodine

OBJECTIVES: Primary trigeminal neuralgia (PTN) is a common cranial nerve disease in neurosurgery, which seriously endangers the physical and mental health of patients. Percutaneous balloon compression (PBC) has become an effective procedure for the treatment of PTN by blocking pain conduction through minimally invasive puncture. However, the recurrence of facial pain after PBC is still a major problem for PTN patients. Intraoperative balloon shape, pressure and compression time can affect the prognosis of patients with PBC after surgery. The foramen ovale size has an effect on the balloon pressure in Meckel's lumen. This study aims to analyse the predictive value of foramen ovale size for postoperative pain recurrence of PBC by exploring the relationship between foramen ovale size and postoperative pain recurrence of PBC. METHODS: A retrospectively analysis was conducted on the clinical data of 60 patients with PTN who were treated with PBC in Department of Neurosurgery, Affiliated Hospital of Chengde Medical College from November 2018 to December 2021. We followed-up and recorded the Barrow Neurological Institute (BNI) pain score at 1, 3, 6 and 12 months after operation. According to the BNI pain score at 12 months after surgery, the patients were divided into a cure group (BNI pain score I to Ⅱ) and a recurrence group (BNI pain score Ⅲ to Ⅴ). The long diameter, transverse diameter and area of foramen ovale on the affected side and the healthy side of the 2 groups were measured. Receiver operating characteristic (ROC) curve and area under the curve (AUC) were used for analysis the relationship between the recurrence of pain and the long diameter, transverse diameter, area of foramen ovale on the affected side, and aspect ratio, transverse diameter ratio, area ratio of foramen ovale on the affected side to healthy side in the 2 groups. RESULTS: At the end of 12 months of follow-up, 50 (83.3%) patients had pain relief (the cured group), 10 (16.7%) patients had different degrees of pain recurrence (the recurrence group), and the total effective rate was 83.3%. There were no significant differences in preoperative baseline data between the 2 groups (all P>0.05). The long diameter of foramen ovale on the affected side, the long diameter ratio and area ratio of foramen ovale on the affected/healthy side in the cured group were significantly higher than those in the recurrence group (all P<0.05), and there were no significant differences in the transverse diameter and area of foramen ovale on the affected side and the transverse diameter ratio of foramen ovale on the affected/healthy side between the 2 groups (all P>0.05). The ROC curve analysis showed that the AUC of the long diameter of foramen ovale on the affected side was 0.290 (95% CI 0.131 to 0.449, P=0.073), and the AUC of aspect ratio of foramen ovale on the affected side to healthy side was 0.792 (95% CI 0.628 to 0.956, P=0.004). The AUC of area ratio of foramen ovale on the affected side to healthy side was 0.766 (95% CI 0.591 to 0.941, P=0.008), indicating that aspect ratio and area ratio of foramen ovale on the affected side to healthy side had a good predictive effect on postoperative pain recurrence of PBC. When aspect ratio of foramen ovale on the affected side to healthy side was less than 0.886 3 or area ratio of foramen ovale on the affected side to healthy side was less than 0.869 4, postoperative pain recurrence was common. CONCLUSIONS Accurate evaluation of the foramen ovale size of skull base before operation is of great significance in predicting pain recurrence after PBC.
Humans ; Retrospective Studies ; Foramen Ovale ; Treatment Outcome ; Trigeminal Neuralgia/surgery* ; Pain, Postoperative/etiology* ; Recurrence

Objective: To examine the clinical efficacy of myectomy guided by personalized three-dimensional reconstruction and printing for patients with obstructive hypertrophic cardiomyopathy. Methods: The clinical data of 28 patients with obstructive hypertrophic cardiomyopathy, who underwent septal myectomy guided by personalized three-dimensional reconstruction and printing in the Department of Cardiaovascular Surgery, Guangdong Provincial People's Hospital from May 2020 to December 2021, were retrospectively analyzed. There were 14 males and 14 females, aging (51.1±14.0) years (range: 18 to 72 years). Enhanced cardiac computed tomography images were imported into Mimics software for preoperative three-dimensional reconstruction. The direction of the short axial plane of each segment was marked perpendicularly to the interventricular septum on the long axial plane of the digital cardiac model, then the thickness was measured on each short axial plane. A figurative digital model was used to determine the extent of resection and to visualize mitral valve and papillary muscle abnormalities. Correlation between the length, width, thickness, and volume of the predicted resected myocardium and those of the surgically resected myocardium was assessed by Pearson correlation analysis or Spearman correlation analysis. The accuracy of detecting mitral valve and papillary muscle abnormalities of transthoracic echocardiography and three-dimensional reconstruction was also compared. Results: There was no death or serious complications like permanent pacemaker implantation, re-sternotomy for bleeding, low cardiac output syndrome, stroke, or multiple organ dysfunction syndromes in the whole group. Namely, the obstruction of the left ventricular outflow tract was effectively relieved. The systolic anterior motion of the anterior mitral valve leaflet was absent in all patients after myectomy. The length, width, and thickness of the predicted resected myocardium by three-dimensional reconstruction were significantly positively correlated with the length (R=0.65, 95%CI: 0.37 to 0.82, P<0.01), width (R=0.39, 95%CI: 0.02 to 0.67, P<0.01), and thickness (R=0.82, 95%CI: 0.65 to 0.92, P<0.01) of the surgically resected myocardium, while the relation of the volume of the predicted resected myocardium and the volume of the surgically resected myocardium was a strong positive correlation (R=0.88, 95%CI: 0.76 to 0.94, P<0.01). Importantly, the interventricular septal myocardial thickness measured by preoperative transthoracic echocardiography showed a moderate positive correlation with the volume of surgically resected myocardium (R=0.52, 95%CI: 0.19 to 0.75, P<0.01). During a follow-up of (14.4±6.8) months (range: 3 to 22 months), no death occurred, and 1 patient was readmitted for endocardial radiofrequency ablation due to atrial fibrillation. Conclusion: Personalized three-dimensional reconstruction and printing can not only visualize the intracardiac structure but also guide septal myectomy by predicting the thickness, volume, and extent of resected myocardium to achieve ideal resection.
Female ; Humans ; Male ; Cardiomyopathy, Hypertrophic/diagnosis* ; Imaging, Three-Dimensional ; Printing, Three-Dimensional ; Retrospective Studies ; Treatment Outcome ; Ventricular Septum ; Adolescent ; Young Adult ; Adult ; Middle Aged ; Aged

After more than 60 years of development, with the deepening of the pathophysiological understanding of obstructive hypertrophic cardiomyopathy, the extent and resection thickness of myectomy have increased significantly. Myectomy combined with the correction of anomalies of the mitral valve apparatus has become the standard treatment of obstructive hypertrophic cardiomyopathy. Only a few centers worldwide can routinely perform it due to the difficulty. Because of the advances of new drugs and interventional therapy, the development of surgical treatment faces many challenges. At the same time, generations of cardiovascular surgeons are constantly trying to promote septal myectomy, including developing devices and the surgical field, as well as improving surgical planning by advanced technology. At present, the superior long-term efficacy of septal myectomy has been confirmed. It is necessary to work together to promote the treatment of hypertrophic obstructive cardiomyopathy, so as to guard people's health.
Humans ; Cardiomyopathy, Hypertrophic/surgery* ; Heart Septum/surgery* ; Mitral Valve/surgery* ; Mitral Valve Insufficiency/surgery* ; Treatment Outcome

Septal reduction therapies, which include septal myectomy and alcohol septal ablation and so on, are the current treatment strategies for patients with obstructive hypertrophic cardiomyopathy and drug-refractory symptoms. With the deepening of theoretical understanding and the rapid development of interventional therapies, some researchers have tried to perform transcatheter mitral valve edge-to-edge repair to treat high-risk patients with hypertrophic cardiomyopathy, including obstructive and non-obstructive. The reported results are relatively satisfactory, but many urgent problems need to be solved, such as the lack of data on animal experiments and large cohort studies, and the unknown medium- and long-term outcomes. However, transcatheter mitral valve edge-to-edge repair brings new ideas for the diagnosis and treatment of patients with hypertrophic cardiomyopathy. On one hand, it can be used as a monotherapy, on the other hand, it can be combined with novel molecular targeted drug therapy or emerging minimally invasive surgical procedures targeting hypertrophic ventricular septum, which deserves our further attention and exploratory research.
Humans ; Treatment Outcome ; Cardiomyopathy, Hypertrophic/surgery* ; Mitral Valve/surgery* ; Ventricular Septum/surgery* ; Hypertrophy

Objectives: To examine the short-term and mid-term effects of surgical treatment of obstructive hypertrophic cardiomyopathy (HCM) in one center. Methods: The perioperative data and short-term follow-up outcomes of 421 patients with obstructive HCM who received surgical treatment at Department of Cardiac Surgery, Zhongshan Hospital, Fudan University from January 2017 to December 2021 were analyzed retrospectively. There were 207 males and 214 females, aged (56.5±11.7) years (range: 19 to 78 years). Preoperative New York Heart Association (NYHA) classification included 45 cases of class Ⅱ, 328 cases in class Ⅲ, and 48 cases in class Ⅳ. Fifty-eight patients were diagnosed with latent obstructive HCM and 257 patients had moderate or more mitral regurgitation with 56 patients suffering from intrinsic mitral valve diseases. All procedures were completed by a multidisciplinary team, including professional echocardiologists involving in preoperative planning for proper mitral valve management strategies and intraoperative monitoring. A total of 338 patients underwent septal myectomy alone, and 59 patients underwent mitral valve surgery along with myectomy. A single transaortic approach was used in 355 patients, and a right atrial-atrial septal/atrial sulcus approach was used in 51 other patients. Long-handled minimally invasive surgical instruments were used for the procedures. Student t test, Wilcoxon rank sum test, χ² test or Fisher exact test were used to compare the data before and after surgery. Results: The aortic cross-clamping time of septal myectomy alone was (34.3±8.5) minutes (range: 21 to 94 minutes). Eighteen patients had intraoperative adverse events and underwent immediate reoperation, including residual obstruction (10 patients), left ventricular free wall rupture (4 patients), ventricular septal perforation (3 patients), and aortic valve perforation (1 patient). Four patients died during hospitalization, and 11 patients developed complete atrioventricular block requiring permanent pacemaker implantation. After discharge, 384 (92.1%) patients received a follow-up visit with a median duration of 9 months. All follow-up patients survived with significantly improved NYHA classifications: 216 patients in class Ⅰ and 168 patients in class Ⅱ (χ²=662.73, P<0.01 as compared to baseline). At 6 months after surgery, follow-up echocardiography showed that the thickness of the ventricular septum ((13.6±2.5) mm vs. (18.2±3.0) mm, t=23.51, P<0.01) and the peak left ventricular outflow tract gradient ((12.0±6.3) mmHg vs. (93.4±19.8) mmHg, 1 mmHg=0.133 kPa, t=78.29, P<0.01) were both significantly lower than baseline values. Conclusion: The construction of the surgical team (including echocardiography experts), proper mitral valve management strategies, identification and management of sub-mitral-valve abnormalities, and application of long-handled minimally invasive surgical instruments are important for the successful implementation of septal myectomy with satisfactory short-and medium-term outcomes.
Male ; Female ; Humans ; Retrospective Studies ; Atrial Fibrillation ; Treatment Outcome ; Cardiomyopathy, Hypertrophic/surgery* ; Mitral Valve Insufficiency/surgery* ; Ventricular Septum