Page 19 - Journal of Structural Heart Disease - Volume 1 Issue 2

Meeting Abstracts
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arm study at 50 U.S. sites and followed for 2 years post-procedure. The primary objective of the study was to evaluate the risk of hemo- dynamic compromise in those receiving the ASO device. Additional safety objectives were to determine the incidence of device and de- livery system-related adverse events. Efficacy was measured as the percentage of subjects for whom closure of the defect was achieved through 2 year follow-up.
Results: Between March, 2008 and May, 2012, 1000 patients (age range 0.3 - 83.6 years, mean 21 ± 22 years) underwent attempted ASD closure with the ASO. Closure was successful during the procedure in 97.9% of subjects. The percentage of subjects with complete closure was 98.5% and 97.9% at 1 month and 2 years respectively. Hemody- namic compromise related to the device occurred in 6 subjects by 2 years (0.65% of 928 evaluable subjects), due to dysrhythmia in 2, device embolization in 1, and cardiac erosion in 3. The rate of car- diac erosion was 0.3% at an average of 83 days from implant (range 12-171 days). The level of physician experience implanting the ASO device in this study showed no statistical significant difference in the rate of hemodynamic compromise (p=0.4 by Fisher’s Exact test). An additional 31 subjects were noted to have pericardial effusions that were treated with observation or pharmacologic therapy. These events of pericardial effusion were adjudicated by an independent committee as not being caused by cardiac erosion.
Conclusions: Closure of ASD with the ASO is safe and effective regard- less of physician experience. The incidence of hemodynamic compro- mise related to cardiac erosion is extremely rare and consistent with previous study results and reports in the literature. (Closure of Atrial Septal Defects with the AMPLATZER® Septal Occluder - Post Approval Study) ClinicalTrials.gov Identifier: NCT00650936.)
#0036
COMPARISON OF EFFICACY OF TRANSCATHETER ASD CLOSURE IN CHILDREN THAT WEIGH LESS THAN 15 KG (≤15) AND 15-20 (>15 - <20) KG
Osman Baspinar1, Mehmet Kervancioglu1, Metin Kilinc1, Derya Aydin Sahin1, Ayse Sulu1, Khaleel Al-Suwayfe1, Ahmet Irdem1, Gokhan Gokaslan2
1Gaziantep University Medical Faculty, Dept of Pediatric Cardiology, Gaziantep, Turkey
2Gaziantep University Medical Faculty, Dept of Cardiothoracic Surgery, Gaziantep, Turkey
Objectives: We investigated safety, efficacy, and follow-up results of transcatheter closure of secundum atrial septal defects (ASDs) in children weighing less than 15 kg compared with children weighing between 15-20 kg.
Methods: Over the last 7.5 years, 274 children with a weight of <20 kg underwent transcatheter closure at a single pediatric center. Patients were divided into the following two groups: Group I: weight ≤15 kg; and Group II: weight >15-<20 kg. Data were analyzed retrospectively.
Results: There were 161 (58.8%) females. The mean diameter of the ASDs measured by echocardiography was 12.4±3.7 (7-30) mm. The mean age of the children was 4.3±1.3 years and the mean weight was 15.2±2.4 kg. Group I included 146 (53.3%), and group II included 128 patients (46.7%). A total of 269 (98.2%) interventional operations were considered successful, and 5 (1.8%) unsuccessful. Major com-
plications occurred in 7 patients (2.5%). The stretched ASD diameter was 14.7±3.9 (7-29) mm in Group I and 15.9±4.7 (7.8-28) in Group II, p=0.063. The ASD diameter/body weight was 0.9±0.2 (0.4-1.8) in Group I and 0.8±0.2 (0.4-1.5) in Group II, p=0.001. The Amplatzer-like device diameter was 16.0±4.1 (9-30) mm in Group I and 17.7±5.0 (9-34) mm in Group II, p=0.004. The patch-like device diameter was 28.8±4.6 (20-35) mm in Group I and 29.4±4.1 (20-33) in Group II, p=0.716. The delivery sheath was measured at 8.4±1.4 (6-12) F in Group I and 8.8±1.5 (6-12) F in Group II, p=0.039. Fluoroscopy time was recorded as 9.9±7.8 (3.2-48.6) min in Group I and 8.9±6.7 (2.3- 30.7) min in Group II, p=0.587. There were no statistically significant difference in the rate of unsuccessful procedures and complication rates between the patient groups (p=0.762 and p=0.836).
Conclusion: Transcatheter closure of ASDs in small children is feasible and is not associated with a greater risk of significant complications.
#0037
COMPARISON OF IN VIVO NEOENDOTHELIZATION PROCESS OF THREE ATRIAL SEPTAL DEFECT OCCLUDER DEVICES (AMPLATZER VERSUS LIFETECH VERSUS OCCLUTECH) AT CHILDHOOD
Derya Aydin Sahin1, Osman Baspinar1, Ayse Sulu1, Tekin Karsligil2, Seval Kul3
1Gaziantep University Medical Faculty, Dept of Pediatric Cardiology, Gaziantep, Turkey
2Gaziantep University Medical Faculty, Dept of Microbiology, Gaziantep, Turkey
3Gaziantep University Medical Faculty, Dept of Statistics, Gaziantep, Turkey
Objectives: We investigated neoendothelization process of transcath- eter closure of secundum ASD in children comprising of three differ- ent occluders in vivo way.
Methods: 44 children underwent transcatheter ASD closure. Patients were divided into the following three groups: Group I: Amplatzer, Group II: Lifetech CeraFlex, and Group III: Occlutech Figulla Flex II septal occluders were used. Data analyzed prospectively. Markers of three phase (PDGF, IL-1α, TGF-β1, VEGF, FGF-2, MMP-9 and FGF-1) of wound healing process were studied at the all patients before the intervention, and 1th day, 10th day and 1th month of after the inter- vention.
Results: The mean age of children was 7.1±3.5 (2-17) and the mean weight was 26.1±15.1 (11-78.6) kg. The mean diameter of the ASDs was 13.6±3.9 (8-26) mm. All interventional operations were consid- ered successfully. Group I (ASO) 15 (34.1%), Group II (CSO) 14 (31.8%), and Group III (OSO) included 15 (34.1%) patients. There was no statis- tically difference between Groups regarding number of patients, pa- tient ages, defects sizes, device diameters, and total septum/device ratio (p>0.05). Inflammatory (PDGF, TGF β-1) and proliferative phase parameters (VEGF, FGF-2) increased after procedure (p<0.05). But scar formation parameters (MMP-9, FGF-1) did not changed at the end of first month. There were no statistically significant difference in the neoendothelizaton process between the occluders (p>0.05).
Conclusion: All three devices made of Nitinol with some different sur- face coating techniques. One possible explanation of these manufac- turing features were claimed facilitate of neoendothelization. But all
Journal of Structural Heart Disease, August 2015
Volume 1, Issue 2: 36-111