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.

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>

Fibrinolytic therapy for femoral artery thrombosis after left cardiac catheterization in children / 中华心血管病杂志

<p><b>OBJECTIVE</b>The study was conducted to investigate the feasibility and effectiveness of fibrinolytic therapy for femoral artery thrombosis after left cardiac catheterization in children.</p><p><b>METHODS</b>Thrombolytic therapy with urokinase was applied in 16 children (5 males) with femoral artery thrombosis after left cardiac catheterization. Patients were given a bolus injection of heparin, 100 U/kg. 30,000-100,000 U boluses of urokinase were injected intravenously, and then a continuous infusion of 10,000-50,000 U/h was started. Transcatheter thrombolysis was performed once previous procedures failed.</p><p><b>RESULTS</b>All 16 patients presented lower limbs ischemia after left cardiac catheterizations. The age was (2.6 +/- 1.9) years, the height was (85.3 +/- 13.1) cm, the weight was (11.2 +/- 3.8) kg. Patients with cyanotic and acyanotic congenital heart disease were 2 and 14, respectively. Interventional therapy was performed in 12 patients. Absent arterial pulsations were found in 15 patients and reduced arterial pulsation in 1 patient. Femoral arterial perfusion became normal in all patients (3 after transcatheter thrombolysis, 11 post intravenous thrombolysis and 2 post intravenous heparin). The average doses of heparin and urokinase were (950 +/- 682) U and (295,357 +/- 198,770) U. The average duration of therapy was (7.25 +/- 5.31) h. Mild residual stenosis were found in 2 patients post various treatments.</p><p><b>CONCLUSION</b>Fibrinolytic therapy with urokinase is a safe and useful modality for children with femoral artery thrombosis after left cardiac catheterization.</p>

Clinical and angiographic characteristics of mid-ventricular hypertrophic obstructive cardiomyopathy / 中华心血管病杂志

<p><b>OBJECTIVE</b>To analyze the clinical and angiographic characteristics of mid-ventricular hypertrophic obstructive cardiomyopathy (MV-HOCM).</p><p><b>METHODS</b>MV-HOCM was diagnosed in 5 patients [3 males, mean age: 16 - 73 (44 ± 22) years]. Left ventricular catheterization and angiography were performed in all patients, and the pressures were recorded in the left ventricular apical chamber, basal chamber, outflow tract and ascending aorta.</p><p><b>RESULTS</b>Of five patients with MV-HOCM, chest discomfort occurred in four patients and syncope in two patients. All patients presented systolic murmur and asymmetric left ventricular hypertrophy. The thickness of ventricular septum was 19 - 31 (23.8 ± 5.4) mm, the dimension of left ventricle was 35 - 55 (43.4 ± 7.4) mm and the LVEF was 53% - 70% (64.2% ± 6.9%). Electrocardiogram showed left ventricular hypertrophy with Q waves in all patients, ventricular tachycardia in 1 patient and complete left bundle branch block in 1 patient. Mid-ventricular obstruction was found in all patients and the pressure gradient in mid-ventricle was 45 - 102 (68.6 ± 24.1) mm Hg (1 mm Hg = 0.133 kPa). Coronary angiogram documented muscular bridge presented in 1 patient and coronary artery disease in 1 patient. Left ventricular apical aneurysm was seen in 2 patients.</p><p><b>CONCLUSION</b>MV-HOCM was a distinguished subtype of hypertrophic obstructive cardiomyopathy, and left cardiac catheterization and angiography examinations are necessary for confirming diagnosis and guiding related therapy.</p>

Angiocardiographic characteristics of patients post bidirectional Glenn procedure / 中华心血管病杂志

<p><b>OBJECTIVE</b>The study was performed to observe the angiocardiographic characteristics of patients post bidirectional Glenn procedure.</p><p><b>METHODS</b>Thirty-eight consecutive patients [24 male/14 female, age 0.9 - 28 (7.8 ± 5.6) years] underwent bidirectional Glenn procedure were included in this study. Postoperative cardiac catheterization and angiocardiography were performed at 2 - 7 (4.1 ± 1.9) years after bidirectional Glenn procedure.</p><p><b>RESULTS</b>Of 38 patients, pulmonary arterial mean pressure (PAMP) was (14.8 ± 4.5) mm Hg (1 mm Hg = 0.133 kPa), the mean pressure of superior vena cava (MPSVC) was (15.4 ± 5.4) mm Hg and no pressure gradient was detected. Elevated pulmonary arterial pressure was evidenced in 9 patients: PAMP was (21.5 ± 2.9) mm Hg and MPSVC was (22.9 ± 5.1) mm Hg. Systemic venous collateral channels (SVCC) were shown in 14 patients and PAMP [(16.7 ± 5.7) mm Hg vs. (13.7 ± 3.4) mm Hg, P < 0.05] and MPSVC [(17.8 ± 7.2) mm Hg vs. (14.0 ± 3.6) mm Hg, P < 0.05] were higher in SVCC patients compared to patients without SVCC. Transcatheter closure was successfully performed in 2 patients. Distribution of SVCC was as follows: Posterior SVCC in 12 patients (associated anterior SVCC in 3 patients and middle SVCC in 1 patient), middle SVCC in 2 patients. Pulmonary arteriovenous fistulae were presented in 2 patients. Aortopulmonary collateral arteries were presented in another 2 patients and were successfully occluded percutaneously.</p><p><b>CONCLUSION</b>Catheterization and angiocardiography play an important role in recognizing the complications post bidirectional Glenn procedure.</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>

Analysis of complications during and post interventional therapy of congenital heart disease / 中华心血管病杂志

<p><b>OBJECTIVE</b>To analyze the incidence and cause of complications during and after interventional therapy for congenital heart disease (CHD).</p><p><b>METHODS</b>From April 1986 to April 2009, 388 out of 6029 patients with CHD developed complications during and post interventional therapy, another 5 patients died post procedure, clinical data from these 393 patients were retrospectively analyzed. The patients with severe functional insufficiency requiring intervention or surgery during and after interventional therapy were classified as severe complications.</p><p><b>RESULTS</b>The overall complication rate was 6.44% [7.69% post atrial septal defect occlusion, 4.20% post patent ductus arteriosus (PDA) occlusion, 1.31% post percutaneous balloon pulmonary valvuloplasty, 14.94% post ventricular septal defect occlusion, 3.13% post percutaneous closure of aortopulmonary collaterals, 30.95% post catheter embolotherapy of pulmonary arteriovenous malformations, 12.50% post transcatheter closure of coronary artery fistulae, 20.00% post transcatheter closure of ruptured sinus of Valsava aneurysm, 66.67% post percutaneous balloon aortic valvuloplasty]. The severe complication rate was 0.65%(39/6029). The procedure-related mortality rate was 0.08% (5/6029), 0.26% (2/761) post percutaneous balloon pulmonary valvuloplasty, 0.05% (1/2070) post PDA occlusion, 9.10% (1/11) post balloon atrial septostomy, 33.33% (1/3) post percutaneous balloon aortic valvuloplasty. Emergency Cardiovascular surgery rate was 0.22% (13/6029). Selective surgery was required in 0.13% (8/6029) of patients post procedure. Two patients (0.03%) received permanent pacemaker implantation.</p><p><b>CONCLUSIONS</b>The severe complications and mortality rate of interventional therapy for CHD are relative low. Post procedure follow-up is needed fro monitoring possible procedure-related complications.</p>

Prevalence and risk factors of atrial tachyarrhythmia before and after percutaneous closure of secundum atrial septal defect in patients over 40 years of age / 中华心血管病杂志

<p><b>OBJECTIVE</b>In this study, we attempted to observe the prevalence and risk factors of atrial tachyarrhythmias (AT) before and after transcatheter closure of atrial septal defect (ASD).</p><p><b>METHODS</b>264 adult patients aged over 40 years (67 men and 197 women) who underwent transcatheter closure of ASD between September, 1997 and December, 2005 were included in this study. Incidence of preoperative and postoperative AT was analyzed, risk factors for AT were determined with multivariate stepwise logistic regression analysis.</p><p><b>RESULTS</b>Incidence of AT before closure was 9.1% (24/264). Twenty-nine patients (11.0 percent) developed AT after transcatheter closure (24 atrial fibrillation, 1 paroxysmal flutter, 4 paroxysmal atrial arrhythmia). The prevalence in patients of 40 to 49 years, 50 to 59 years and above 60 years was 4.3%, 14.6% and 26.3%, respectively. Most patients with atrial fibrillation were symptomatic. Compared to patients without AT, patients developed AT after closure were significantly older (53.0 +/- 7.6 years vs. 47.8 +/- 6.6 years, P < 0.01) and had larger defects (23.5 +/- 5.7 mm vs. 21.3 +/- 5.2 mm, P > 0.05), higher systolic pulmonary pressure (38.4 +/- 13.1 vs. 34.1 +/- 10.1, P < 0.05), larger left atrium dimension [(38.0 +/- 3.9) mm Hg (1 mm Hg = 0.133 kPa) vs. (33.6 +/- 4.4) mm Hg, P < 0.01], larger end diastolic right ventricular dimension [(34.7 +/- 5.9) mm vs. (32.1 +/- 6.8) mm, P > 0.05], higher incidence of tricuspid regurgitation (96.6% vs. 75.3%, P = 0.01), higher incidence of preoperative AT (51.7% vs. 3.8%, P < 0.01) and higher incidence of hypertension (27.6% vs. 10.2%, P = 0.013). Multivariate analysis showed that older age [odds ratio (OR) 2.659, 95 percent confidence interval (CI) 1.080 to 6.547, P < 0.05], presence of preoperative AT (OR 54.311, CI 9.819 to 300.395, P < 0.01), and left atrial enlargement (OR 8.529 per 10 mm increment, CI 2.162 to 33.643, P < 0.01) were independent predictors of AT after closure.</p><p><b>CONCLUSIONS</b>Incidence of AT was similar before and after percutaneous closure in patients with atrial septal defects aged 40 years and over. The risk of AT is related to the age at the time of transcatheter closure, the presence of preoperative AT and enlarged left atria.</p>

Morphological features of secundum atrial septal defect in adult and implications for transcatheter closure / 中华心血管病杂志

<p><b>OBJECTIVE</b>To study the morphological features of secundum atrial septal defect (ASD) in adult and the implications for transcatheter closure.</p><p><b>METHODS</b>Transcatheter closure using Amplatzer duct occluder was performed in 272 adult patients with ASD from September 1997 to December 2005. The morphological features were evaluated by transthoracic echocardiography (TTE) and transesophageal echocardiography (TEE). The size, length and thickness of rims, occluder diameter, the complete closure rate, residual shunt rate and complications were compared in patients with deficient and/or thin rims (Group A, n = 135) and patients with well-developed rims (Group B, n = 137).</p><p><b>RESULTS</b>The complete closure rate was 97.8% (132/135) in group A and 99.3% (136/137) in group B. There were 74 cases with deficient rims, 39 cases with thin rims and 22 cases with both deficient and thin rims in group A. Gender distribution, age, operation successful rate, residual shunt rate and complication rate were similar between the 2 groups. The defect diameters measured by TTE (18.9 +/- 5.5 mm vs. 16.5 +/- 4.8 mm, P < 0.01), TEE (22.7 +/- 5.0 mm vs. 20.0 +/- 5.5 mm, P < 0.01) and occluder diameters used (29.1 +/- 5.7 mm vs. 26.0 +/- 5.9 mm, P < 0.01) were significantly larger in groups A than that in group B. The systolic pulmonary artery pressure was also significantly higher in groups A than that in groups B (36.9 +/- 11.9 mm Hg vs. 32.6 +/- 9.1 mm Hg, P < 0.01). There are significant correlations between occluder diameters and defects measured by either TTE or TEE in both groups (group A, TTE: r = 0.709, TEE: r = 0.850; group B, TTE: r = 0.716, TEE: r = 0.915, P all < 0.01).</p><p><b>CONCLUSIONS</b>Poor residual rims were found in around 50% of adult patients with ASD. Transcatheter closure of these defects could be successfully performed with larger occluders. The defect diameters measured by TTE and TEE, especially the latter, could guide the occluder selection.</p>

Comparison between transcatheter and surgical closure of secundum atrial septal defect in patients over 40 years old / 介入放射学杂志

Objective To compare the safety and efficacy of transcatheter closure of secundum atrial septal defect(ASD)with surgical closure in patients over 40 years old.Methods A single center, nonrandomized concurrent study was performed in 233 consecutive adults from January,2004 to December, 2005.The patients were assigned to either the device or surgical closure group according to the patients' options.Technical success rate,complications,residual shunt,hospital stay,amount of blood transfusion and cost were compared .Results A total of 137 patients were in the group undergoing device closure,whereas 96 patients were in the surgical group.There was no differences in age,sex distribution or baseline cardiac function between the two groups.The sizes of the ASD were(18.9?5.4)mm for the device group and(24.9?6.8)mm for the surgical group(P＜0.001).The technical success rates were 97.1% for the device group and 100% for the surgical group(P=0.151).The residual shunt rates were 0.7% for the device group and 0% for the surgical group(P=0.583).Mortality was zero for both groups.The complication rates were 16.1% for the device group and 30.2% for the surgical group(P=0.015).The blood transfusion amounts were(273.1?491.5)ml for the surgical group and 0 ml for the device group(P＜0.001).The lengths of hospital stay were (4.6?3.3)days for the device group and(12.0?4.0)days for the surgical group(P＜0.001).The costs of hospital stay were 39 570.0?5 929.5 RMB for the device group and 29 839.6?7 533.1 RMB for the surgical group(P＜0.001).Conclusions The technical success rates for surgical versus device closure of ASD were not significantly different,however,the complication rate was lower and the length of hospital stay was shorter for device closure than those for surgical repair.Transcatheter closure of seeundum ASD is a safe and effective alternative to surgical repair in selected patients.(J Intervent Radiol,2007,16:79-83)