Efficacy and safety of a parylene-coated occluder for atrial septal defect: a prospective, multi-center, randomized controlled clinical trial / 中华医学杂志(英文版)

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).@*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.

Feasibility, efficacy and safety of transbrachial access for interventional therapy on paravalvular leak post surgical valve replacement / 中华心血管病杂志

Objective: To investigate the feasibility, efficacy and safety of transbrachial access for interventional therapy on prosthetic paravalvular leak (PVL) post surgical valve replacement. Methods: This is a retrospective study. Patients with PVL after surgical valve replacement who underwent interventional therapy via the brachial artery approach in Structural heart disease center of Fuwai hospital between August 2017 and October 2019, were included. All patients underwent puncture of the brachial artery under local anesthesia, angiography and transcatheter closure procedure were performed. The procedure was performed under transthoracic echocardiography (TTE) guidance. Baseline data, operation data and pre-and post-operative TTE examination results were collected and analyzed. Postoperative complications were recorded and operational adverse events were obtained during follow up in the outpatient department after discharge. The operation success rate was calculated, which was defined as the degree of perivalvular regurgitation decrease by 1 grade and above according to TTE without interfering the valve movement and coronary artery blood flow within 30 days after occluder placement. Results: A total of 10 patients were enrolled in this study, the mean age was (57.5±14.6) years, and 6 patients were males. There were 7 cases with aortic PVL, and 3 cases with mitral PVL. Except for one patient who was converted to the femoral vein-transseptal approach, the other 9 patients were successfully implanted with the devices via the brachial artery approach. The operation time was (103.3±34.0) minutes, and there was no need for rigorous bed rest after the operation. The median hospital stay was 7.5 (3.0, 9.8) days. The operation success rate was 9/10 via the brachial artery approach. The differences in the degree of perivalvular regurgitation, New York Heart Association (NYHA) classification, left ventricular end diastolic diameter and left atrial diameter before and after operation were statistically significant (all P<0.05). One case developed new hemolysis with renal insufficiency on the second day after procedure and discharged after successful dialysis. Another case experienced complication of brachial artery pseudoaneurysm after procedure and discharged after successful treatment with thrombin injection. The mean follow-up time was (14.3±7.9) months. During the follow-up, NYHA classification remained as Ⅰ/Ⅱ in 9 patients, no operational adverse events were observed. Conclusions: Transbrachial access for interventional therapy on PVL post surgical valve replacement is a feasible, effective, and safe procedure. It has the advantages of simplifying the operation process and reducing postoperative bed rest time.

Use of covered Cheatham-Platinum stent as the primary modality in the treatment for native coarctation of the aorta / 中华医学杂志(英文版)

<p><b>BACKGROUND</b>Bare stent implantation in the treatment for native and recurrent coarctation of the aorta (CoA) has become established as an alternative to surgery and balloon angioplasty. However, this modality still encounters significant complications during the procedure and/or follow-up. The covered Cheatham-Platinum (CP) stent commonly used to be chosen as a rescue treatment in these patients. The purpose of this study was to evaluate the use of covered CP stent as the primary modality in the treatment for native CoA.</p><p><b>METHODS</b>Twenty-five covered CP stents and 2 bare CP stents were implanted in 25 patients with native CoA. All patients after the intervention were invited for follow-up examinations.</p><p><b>RESULTS</b>The peak systolic gradient across the lesion decreased significantly from a median value of 67.5 mmHg (quartile range, 19.3 mmHg) to 2 mmHg (quartile range, 4.0 mmHg) (P < 0.0001). Stenotic segment diameter increased from a median value of 5.0 mm (quartile range, 1.5 mm) to 17.9 mm (quartile range, 2.5 mm) (P < 0.0001). The median ratio of diameter of the coarctation postprocedure to preprocedure was 4.2 (quartile range, 1.6). All of the CP stents were placed in the suitable position without any acute complications. During a follow-up period of up to 72 months, no complications were encountered. Most of the patients (21/25) were normotensive, apart from four patients requiring antihypertensive medication during the follow-up.</p><p><b>CONCLUSION</b>The implantation of covered CP stent as the primary modality is safe and effective in the treatment for native CoA in adolescents and adults.</p>

Value of cardiac CT examination in middle-aged and elderly patients with atrial septal defect before planned transcatheter closure / 中华心血管病杂志

<p><b>OBJECTIVE</b>To investigate the value of the cardiac CT examination for decision making in middle-aged and elderly patients before planned transcatheter atrial septal defect (ASD) closure.</p><p><b>METHODS</b>Cardiac CT was performed in 63 adult patients [18 males, aged from 50 to 77 years, mean age (56.87 ± 5.79) years] with ASD before planned transcatheter ASD closure. Coronary CT angiography was made for detection of associated cardiovascular diseases, followed by 3D reconstruction of ASD for determination of the defect size in the GE-workstation, results were compared between transthoracic echocardiography measurement, CT measurement, and atrial septal defect occluder waist diameter.</p><p><b>RESULTS</b>Cardiac CT identified additional cardiovascular diseases in 14 patients and decision making was changed based on cardiac CT results. Coronary artery stenosis was detected in 8 patients by cardiac CT, and proved by coronary angiography, and all of them were given comprehensive management: percutaneous coronary intervention and transcatheter ASD closure were successively performed in 2 cases, and 1 case was referred to surgery for both coronary artery bypass graft and surgical ASD repair, and 5 patients were given pharmacological management for coronary artery disease besides transcatheter ASD closure. Cardiac CT identified large ASD with insufficient rim tissue in 2 cases and transcatheter closures were abandoned. Cardiac CT screened out 1 case from those with insufficient posterior inferior rim by transthoracic echocardiography, and transcatheter ASD closure was successfully performed. Cardiac CT ruled out ASD in 1 patient. In addition, cardiac CT detected 1 partial abnormal pulmonary vein connection and 1 ductus arteriosus in this cohort. A correlation on ASD measurements was found between CT size and TTE size (r = 0.80, P < 0.01; Y = 0.84X + 8.85, R(2) = 0.63, P < 0.05), and between ASO size and CT size (r = 0.92, P < 0.01;Y = 0.93X + 4.78, R(2) = 0.84, P < 0.05).</p><p><b>CONCLUSION</b>In middle-aged and elderly patients with ASD for possible transcatheter closure, cardiac CT is valuable on determine ASD size and morphology and could provide incremental information for optimizing clinical management for ASD patients.</p>

Transcatheter closure of coronary artery fistula in children / 中华医学杂志(英文版)

<p><b>BACKGROUND</b>Transcatheter closure of coronary artery fistula (CAF) has emerged as a successful alternative to surgery. We described our experiences in 10 children patients who were accepted for transcatheter closure of CAF.</p><p><b>METHODS</b>Ten children were 3 - 10 years old (seven males) with CAF who underwent percutaneous transcatheter closure between October 1995 and April 2008. Sites of origin of these fistulas were: right coronary artery in seven, left anterior descending coronary artery in two, and left circumflex coronary artery in one patient. Drainage sites of these fistulas were: right atrium in seven, right ventricle in two and left ventricle in one patient. All of these fistulas were congenital and had only one orificium fistula.</p><p><b>RESULTS</b>A Cook coil was used in four patients and an Amplatzer patent ductus arteriosus (PDA) occluder was used in six patients. Checking the angiogram after the procedure revealed complete occlusion in nine patients (90%) and minimal residual flow in one (10%) patient. Technical success was achieved in all patients. Follow-up studies at short term showed complete abolition of shunt in all patients with no evidence of recanalization leading to recurrence of shunt.</p><p><b>CONCLUSIONS</b>Transcatheter therapy using either Cook coil or Amplatzer PDA occluder is suggested to be a safe and effective method of occlusion. The midterm outcome of the intervention for CAF is satisfactory.</p>

Strategy and analysis of early management on ninety multiple trauma patients / 中华外科杂志

<p><b>OBJECTIVE</b>To explore the therapeutical effects through investigating the results of multiple traumas treated by means of damage control surgery (DCS) or early total care (ETC).</p><p><b>METHODS</b>The clinical data of 90 patients with severe multiple traumas admitted from June 2001 to June 2007 were analyzed retrospectively. Forty-five patients were classified to the DCS group, 45 patients to the ETC group as a control. These severely injured patients were selected with an ISS > 25 points.</p><p><b>RESULTS</b>Between the two groups, the recovery time of clearance of lactic acid, body temperature, prothrombin time (PT) and activated partial thromboplastin time (APTT) of DCS group was significantly shorter than that of ETC group (P < 0.05). Incidence of complications and mortality in DCS group was significant less than that in ETC group (P < 0.05). No significant differences existed in the volume of bleeding and duration of surgery (P > 0.05).</p><p><b>CONCLUSIONS</b>The concept of DCS could reduce multiple traumas patients' mortality rate and incidence of complications. The indication of DCS should be the combination of physical feature, mechanism and severity of injuries.</p>

Outcome of interventional therapy of perimembranous ventricular septal defects / 中华心血管病杂志

<p><b>OBJECTIVE</b>To observe the outcome of patients with perimembranous ventricular septal defects (VSD) after transcatheter closure.</p><p><b>METHODS</b>Follow up data were analyzed in 445 VSD patients [203 males, (14.2 +/- 6.8) years] underwent transcatheter closure (TCVSD) using Amplatzer occluder or homemade occluder in Fu Wai hospital from November 2002 to November 2007. Left ventriculography and ascending aorta angiography were performed before and after TCVSD. Routine follow-up including electrocardiogram, echocardiography and X-ray were made at 1, 3, 6 and 12 months post TCVSD and followed at 12 months interval thereafter.</p><p><b>RESULTS</b>Mean follow up time was 25.6 months. There was no death during follow up. Procedure was successful in 417 patients (93.7%) and complete closure within 5 years was achieved in 410 patients (98.3%). During follow up, 2 patients developed complete left bundle branch block and left ventricle enlargement. Complete atrioventricular block was evidenced in 3 patients and 2 patients requiring permanent pacemaker implantations. Newly occurred moderate-large aortic valve regurgitation was found in 2 patients. Newly developed moderate-large tricuspid valve regurgitation was found in 2 patients and moderate mitral valve regurgitation was found in 1 patient.</p><p><b>CONCLUSION</b>Transcatheter closure of perimembranous ventricular septal defects is effective though this procedure is also associated with limited complications.</p>

Development of DICOM software platfrom for medical image communication / 中国医疗器械杂志

In this paper, we have brought forward the framework design of DICOM software platform, using the SUR-DICOM-Lib software and have completed the connection test with the RSNA-CTNT Test Node. PACS, DICOM, realize

Research on the distributed PACS based on grid technology / 中国医疗器械杂志

In this paper, we introduce the grid technology into the design of the distributed PACS. First, we analyse the architecture and functions of OGSA-DAI, and then, introduce a model of the distributed PACS based on OGSA-DAI, and give a detailed analysis on its basic components and workflow. Finally, we make a conclusion on the distributed PACS based on grid technology.

Transcatheter closure of perimembranous ventricular septal defects: a clinical application in children / 中华儿科杂志

<p><b>OBJECTIVE</b>To evaluate the safety and efficacy of transcatheter closure of perimembranous ventricular septal defects (TCVSD) in children.</p><p><b>METHODS</b>From November 2002 to July 2004, fifty children (26 males and 24 females) with perimembranous (ventricular septal defect, VSD) underwent an attempt of transcatheter closure using the amplatzer occluder specially designed for perimembranous VSD. Among the 50 children, one of them was diagnosed with aneurysm of aortic sinus, one with dextrocardia, and two with leakage after the surgical repair of VSD. The mean age of patients was (9.1 +/- 4.8) years (ranged from 2 to 17 years). The mean body weight of patients was (33.5 +/- 19.7) kg (ranged from 9 to 81 kg). The mean diameter of VSD measured by transthoracic echocardiography (TTE) was (4.8 +/- 0.9) mm (ranged from 3 to 7 mm). The mean rate of quantity of pulmonary flow/quantity of systemic flow (Qp/Qs) was 1.3 +/- 0.3 (ranged from 1.1 to 2.0), the moderate shunt from left to right was found in 4 patients and the small shunt from left to right in the rest. Occluder was released through the right heart system. All patients were followed up in 1, 3, 6 and 12 months after procedures of TTE, X-ray and electrocardiography.</p><p><b>RESULTS</b>The devices were deployed successfully in 47 patients, the rate of success was 94%. There was a tiny (< 3 mm) residual shunt in 2 patients after closure. During the follow-up of 6 months, only one patient had a tiny residual shunt. Complete left bundle branch block (LBBB) was found in one child who was examined with electrocardiograph 2 weeks later. There was no other severe complication. After 1 to 18 months (mean 7 months) follow-up, all patients demonstrated a great decrease (from 38.5 +/- 4.6 mm pre-closure to 35.2 +/- 5.1 mm post-closure) in their left ventricle end-diastolic dimension (LVEDD, P < 0.05).</p><p><b>CONCLUSION</b>This study demonstrated that transcatheter closure of membranous VSD using occluder would be safe and effective for children, and the results of short-term was satisfied. Further clinical trials are underway to assess the long-term result.</p>