Page 82 - Journal of Structural Heart Disease - Volume 1 Issue 2

111
Meeting Abstracts
come an accepted alternative to open heart surgery. Currently, the only approved devices in the United States are the Amplatzer Septal Occluder (ASO) and the Gore Helex Device. The Occlutech Figulla Flex II (OFF) is a new device designed to close ASD. The purpose of this study is to report on the results of the first randomized controlled multicenter clinical trial of the efficacy and safety of the OFF with that of the ASO for the closure of secundum ASD. The randomization scheme was 2:1 in favor of the study device (OFF).
Methods: The primary efficacy end point, early efficacy success rate, was defined as the rate of successful device placement and success- ful closure of the defect without major complications, surgical rein- tervention, device embolization or presence of moderate or large residual shunt at discharge from the hospital. Safety end points were defined as the rate of major and minor complications. The decision was made to perform interim analysis when 70% of the patients were treated and one of three decisions had to be made: stop the trial due to proven non-inferiority (reject the null hypothesis that OFF is in- ferior to ASO), stop the trial due to futility (accept the null hypothe- sis) or continue the trial with recalculated sample size. At the interim analysis data cut, 158 patients were randomized (107 OFF/51 ASO) at a median age of 12 yr (range 3-79 yrs) and median weight of 42 kg (range 13-125 kg), underwent device closure. 65.2% were female. Of the 158 patients, only 120 (76%) completed the 6-months follow up.
Results: The device was placed successfully from the 1st attempt in 99.1% of the OFF device group vs 90.2% of the ASO group (p<0.05). 94.393% of the OFF group achieved early efficacy success vs 90.196% of the ASO group (p=0.000556) indicating that the null hypothesis is rejected since the p value was less than 0.0082, the nominal signifi- cance level at the interim analysis. The incidence of major complica- tions for all 158 patients was 5.6% for the OFF group compared to 9.8% for the ASO.
Conclusion: The Occlutech Figulla Flex II device was not inferior to the Amplatzer septal occluder with less complications and more efficacy than the ASO. Based on these data, the trial was discontinued due to the improved results of the OFF.
#0191
OUR EXPERIENCE OF THE PFM MEDICAL COILS FOR PDA AND VSD USAGE
Igor Ditkivskyy, Bogdan Cherpak, Yashchuk Nataliia
Amosov National Institute of Cardiovascular Surgery, Kiev, Ukraine
There are many simple congenital heart diseases with small left-to- right shunts, which cannot be closed with occluders. The most com- mon of those is ventricular septal defect (VSD) and patent ductus ar- teriosus (PDA). The best option for these small shunts is coils. Amosov National Institute of cardiovascular surgery has extensive experience in usage of the new coils manufactured by the PFM Medical Company (Germany, Cologne). From 2008 to 2015 in our institute 296 PDA in 294 pts and and 19 VSD in 19 pts were occluded with PFM production (Nit-Occlud® PDA and Nit-Occlud® Lê VSD coils). The short-term and the long-term results of the treatment is promising. Mean follow-up period was 21±6,5 month. No serious complications had been ob- served in the short-term and medium-term follow-up. No heart block or other serious rhythm disturbances have been observed in peri- membranous VSD cases. 5 VSD pts and 8 PDA pts had small residual shunt on discharge from the hospital. Three month after procedure, 3
VSD pts and 2 PDA pts had trivial residual shunt.
Conclusion: PFM coils are safe and effective devises for percutaneous PDA and perimembranous VSD closure.
#0192
CARDIAC CT FOR EVALUATION OF SEPTAL DEFECTS - LOW RADIATION EXPOSURE USING 128 SLICE DUAL- SOURCE CT
Nobuo Oyama1, Kazuo Itahashi1, Takashi Soga2, Takanari Fujii3, Kazuto Fujimoto3, Hideshi Tomita3
1 Department of Pediatrics, Showa University School of Medicine, Tokyo, Japan
2 Children’s Medical Center, Showa University Northern Yokohama Hospital, Yokohama, Japan
3 Cardiovascular Center, Showa University Northern Yokohama Hospital, Yokohama, Japan
Introduction: Although cardiac CT has been accepted as a useful imaging modality for documentation of vascular lesions, its role in evaluation of intra-cardiac lesions such as ASD and VSD has not been established. Using 128 slice dual-source CT, we analyzed its useful- ness in anatomical assessment for ASD and VSD.
Subjects and Methods: Using prospective ECG gated method, we re- constructed volume rendering images and multi-planar reconstruc- tion images in 22 patients of ASD (median 46 years), and 5 of VSD (median 2 months). Transesophageal echocardiography (TEE) was performed in 11 patients of ASD, transthoracic echocardiography (TTE) was performed in all patients of VSD, respectively.
In ASD, we compared the defect diameter and existence of appropri- ate rims ≥ 5mm by CT and TEE. In VSD, we evaluated its location and the diameter of VSD in 2 methods. In all patients, effective radiation dose was calculated from age corrected dose-length product.
Results:
1. There was a strong correlation between CT and TEE measure- ment in both the long axis and the short axis diameter of ASD (Long axis, CT=0.96×TEE+1.76, r=0.96, p<0.0001; Short axis, CT=0.86×TEE+1.52, r=0.88, p 0.001). Existence of appropriate rim in 2 methods agreed in all for SVC and aortic rims, in 10/11 for IVC rims, and 9/11 for posterior rims.
2. The location of VSD in 2 methods agreed in all patients. The defect diameter by CT in patients of muscular was closely relat- ed to that by TTE, however measurement of the diameter was difficult in patients of perimembranous VSD.
3. The effective radiation dose ranged 0.26-4.24 (1.57 + 1.22, mean+SD) in ASD and 0.31-1.52 (0.86+0.53) in VSD, respectively.
Discussion: In ASD, measurement of the defect diameter by cardiac CT was reliable. Although there might be some limitation in the flim- sy rim, existence of appropriate rims could be qualitatively assessed. Both location and the diameter may be evaluated by cardiac CT in muscular VSD, however, measurement of the diameter in perimem- branous VSD is still a problem to be solved. Prospective ECG-trig- gered method could decrease radiation dose.
In conclusion, dual-source CT is now a valuable tool for evaluation of the intracardiac septal defect in low dose radiation.
19th Annual PICS/AICS Meeting Abstracts