Efficacy and safety of a parylene-coated occluder for atrial septal defect: a prospective, multi-center, randomized controlled clinical trial.

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.

Use of covered Cheatham-Platinum stent as the primary modality in the treatment for native coarctation of the aorta.

BACKGROUND: 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. METHODS: 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. RESULTS: 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. CONCLUSION: The implantation of covered CP stent as the primary modality is safe and effective in the treatment for native CoA in adolescents and adults.

[Value of cardiac CT examination in middle-aged and elderly patients with atrial septal defect before planned transcatheter closure].

OBJECTIVE: 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. METHODS: 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. RESULTS: 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). CONCLUSION: 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.

[Analysis of complications during and post interventional therapy of congenital heart disease].

OBJECTIVE: To analyze the incidence and cause of complications during and after interventional therapy for congenital heart disease (CHD). METHODS: 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. RESULTS: 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. CONCLUSIONS: 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.

[Effects of transcatheter closure of extracardiac Fontan fenestration by Amplatzer duct or septal occluder in three patients].

OBJECTIVE: The purpose of this study was to report our experiences from the transcatheter closure of patent fenestration after total cavopulmonary connection (TCPC) with an extra cardiac conduit. METHODS: Three patients (7, 14 and 8 years old) with various forms of functionally univentricular heart lesions received a total cavopulmonary connection with an extra cardiac conduit as a final reconstructive procedure. Transcatheter occlusion of the fenestration was accomplished using a 8/6 mm Amplatzer duct occluder in one patient, and 5 mm or 10 mm Amplatzer septal occluder in the other two patients. Residual shunting following occlusion was assessed using angiography and echocardiography. RESULTS: Post total cavopulmonary connection with an extra cardiac conduit, diagnostic catheterization revealed normal pressures in the superior vena cava and pulmonary artery without obstruction at the site of the anastomosis. Angiography of the extra cardiac conduit confirmed the communication between the conduit and the atrium in all three patients and patients still suffered from cyanosis and low oxygen saturation. Immediate full occlusion of fenestration was obtained in all patients. Post closure, mean central venous pressure returned to normal accompanied with significantly increased oxygen saturation. Cyanosis was also significantly attenuated. There were no procedural complications or device failures at intra-hospital and during the 3 to 6 months follow up period. CONCLUSIONS: The Amplatzer septal or duct occluder device is a safe and effective strategy for the Fontan fenestration occlusion.

[Endovascular stent-graft repair for penetrating atherosclerotic ulcer of the descending aorta].

OBJECTIVE: To summarize the clinical experience and effectiveness of endovascular stent-graft placement for the treatment of penetrating atherosclerotic ulcer of the descending thoracic aorta. METHODS: From August 2002 to February 2006, 14 patients with penetrating atherosclerotic ulcer accepted endovascular stent-grafts placement. All patients were men, their average age was 60 years. The clinical symptoms included thoracalgia or notalgia or celiodynia (n = 13) and hemoptysis (n = 3). 11 patients had hypertension. All patients were diagnosed by CT or MRI scans. Via the cutdown on a femoral artery at local anesthesia, the stent-graft was placed after completion angiography. Then DSA examine was repeated. X-ray and EBCT or MDCT scans were performed at follow-up. RESULTS: 16 Stent-grafts were successfully placed in 14 patients, in which 2 cases were placed with two stent-grafts respectively. There were Talent stent-grafts (n = 11) and Aegis stent-grafts (n = 5). The diameter of endovascular stent-graft ranged 32 mm to 38 mm exceeding by 10% - 20% of aortic diameter of anchoring zone. Instant angiography revealed no endoleak in 12 patients, minor endoleak in 2 patients. Within the follow-up average 17.2 months, CT scans demonstrated the disappearances of penetrating atherosclerotic ulcer or exclusion of aortic pseudoaneurysm in all patients, and absorption of intramural hematoma in two patients. One patient died of rupture of aortic pseudoaneurysm after one month. CONCLUSION: Penetrating atherosclerotic ulcer can leads to intramural hematoma, dissection, aneurysmal dilatation, pseudoaneurysm, or aortic rupture. Therefore it should be treated once diagnosed. Endovascular stent-graft placement may be an effective treatment for penetrating atherosclerotic ulcer, especially in patients with poor condition.

[Morphological features of secundum atrial septal defect in adult and implications for transcatheter closure].

OBJECTIVE: To study the morphological features of secundum atrial septal defect (ASD) in adult and the implications for transcatheter closure. METHODS: 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). RESULTS: 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). CONCLUSIONS: 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.