Page 22 - Journal of Structural Heart Disease Volume 4, Issue 4

Meeting Abstracts
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any residual ow or heart block. *ADOI is safe and e ec- tive for transcatheter closure of pmVSDs in symptomatic infants and children. The device is a ordable and widely available.
22. ACUTE MYOCARDITIS AND PEDIATRIC DILATED CARDIOMYOPATHY; IMAGE GUIDED DIAGNOSIS BY CARDIAC MRI AND ECHOCARDIOGRAPHY TISSUE DOPPLER IMAGING
Hala Moustafa, Manal Abd El Hamid, Alae Sobeih, Antoine Abd El Messih, Ahmed Kharabish
Cairo University, Cairo, Egypt
Objectives: To di erent acute myocarditis from pediatric dilated cardiomyopathy by using Cardiac magnetic reso- nance imaging (CMRI) and tissue Doppler imaging (TDI).
Patients and methods: Twenty-four patients with sus- pected acute myocarditis or dilated cardiomyopathy underwent CMRI and TDI. CMRI was performed for cardiac functions assessment, detection of myocardial edema, capillary leakage and late Gadolinium enhancement (LGE). Pulsed tissue Doppler imaging (TDI) measures included systolic myocardial velocities at the basal lateral LV and septal wall segments (LV-S´, IVS-S´ respectively), early and late diastolic myocardial velocities and their ratio of the same basal segments ( LV-E´, LV-A´, LV-E´/A´, IVS-E´, IVS-A´ and IVS-E´/A´).
Results:
CMRI ndings: myocardial edema in 100% and capillary leakage in 55.6% of myocarditis group, these 2 ndings are absent in DCM group (p<0.001, p=0.003), while LGE in 66.7% of myocarditis group and 6.7% in DCM (p=0.004).
Tissue Doppler imaging ndings: The median value of IVS- S´ and LV-S´ was signi cantly higher in myocarditis group compared to DCM group [3.99cm/sec and 4.62cm/s versus 3.16cm/s and 3.79 cm/s respectively (p=0.04, p=0.04)].
Conclusion: All myocarditis patients had myocardial edema by CMRI. In patients having acute myocarditis proved by CMRI had less severe left ventricular systolic dysfunction compared to DCM patients detected by TDI.
23. RESULTS OF THE NIT-OCCLUD PDA POST APPROVAL TRIAL
Daniel Levi1, Morris Salem2, Thomas Forbes3, Brent Gordon4, Brian Soriano5, Thomas Jones5, Vivian Dimas6, Alex Javois7,
John Bass8, Darren Berman9, Matthew Gillespie10, John
Moore11, Carl Owada12, Brian Goldstein13
1UCLA, Los Angeles, USA. 2Kaiser Permanente, Los Angeles,
USA. 3Detroit Children's Hosp, Detroit, USA. 4Loma Linda
Univ, Loma Linda, USA. 5Seattle Children's Hosp, Seattle,
USA. 6Children's Hosp of Dallas, Dallas, USA. 7Advocate Christ
Medical Ctr, Chicago, USA. 8Univ of Minnesota, Minneapolis,
USA. 9Nationwide Children's Hosp, Columbus, USA. 10CHOP,
Philedelphia, USA. 11UCSD-Rady Children's Hospital, San Diego,
USA. 12Valley Children's Hosp, Fresno, USA. 13Cincinnati Children's Hosp, Cincinnati, USA
Intro: The FDA granted PMA approval for the Nit-Occlud PDA in 2013 based on the results of the pivotal trial which along with the continued access protocol enrolled 357 patients prospectively. The results of the Nit-Occlud pro- spective post-approval study (PAS) which was performed at 11 centers is reported along with a comparison to the results of the pivotal trial.
Methods: A total of 184 subjects greater than 6 months of age and 5 kg with PDAs less than 4 mm by angiogram were enrolled at 11 centers for the PAS. Patients were followed prospectively with ECHO and clinical assessments at 2 months, 12 months and 24 months post-procedure. These outcomes were compared to the 357 subjects enrolled in the pivotal and continued access protocols.
Results: Of the subjects enrolled in the PAS trial, 68.5% were female, the median age was 3.4 years. 83.7% had a Type A PDA. A venous approach was used in 95.6% of the subjects. There was no signi cant device obstruction to the pulmonary arteries or aorta and there were no deaths, no episodes of hemolysis and no need for blood transfu- sion or surgery. 97.0% (165/170) of subjects had trivial or no residual shunt as assessed by ECHO at the 2 month fol- low-up and the remainder had a small residual shunt. At 12 month follow-up, 98.7% (150/152) had trivial or no residual shunt as assessed by ECHO and the remainder had only small residual shunts. Together with the pivotal study, there was a total of 541 subjects enrolled with no mortal- ity and no serious adverse events. When combining both studies, 97.4% (449/461) had echocardiographic follow up at 1 year demonstrating no signi cant shunt. In both trials, there were a total of ve Nit-Occlud device embolizations and all were snare retrieved with catheters and without clinical consequence.
Conclusion: As evidenced by follow up of 541 patients enrolled prospectively in two large clinical trials, the NitOclud PDA device is a very safe and e ective device for
Journal of Structural Heart Disease, August 2018
Volume 4, Issue 4:114-206