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MCS in Pediatric Heart Failure Continues to Gain Momentum

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Angela Lorts, MD
Cincinnati Children's Hosp
Cincinnati, OH, USA

The pediatric heart failure community continues to build momentum with robust data collection and clinical trials. Pedimacs is gaining acceptance and over 30 centers are now enrolling their patients in the national database. With higher levels of enrollment, the database has collected data on more than 125 children. These data are similar to that of INTERMACS and will be formatted the same, with the new version of INTERMACS/PEDIMACS 4.0. The online data entry is currently under revision but will be back up for online data entry soon.

Many institutions have recently gained IRB approval to waive consent for Pedimacs data collection, which may further increase enrollment. At this time, entering data into this pediatric registry is free of charge. With the completion of the Berlin EXCOR, post approval study data on Berlin heart patients can also be entered into Pedimacs. We anticipate the data on the first 100 pediatric VAD patients entered into Pedimacs to be presented at an upcoming meeting this Fall.

In addition, the Pedimacs steering committee is starting a Web-based VAD conference to share experiences across the various VAD centers. There is a strong commitment to collaborating across centers in order to better the care for children with end stage heart disease. With the small numbers of patients that each center cares for, we must continue to learn from each other.

The PumpKIN trial has completed phase 1 of the training for the VAD trial. The trial will compare the FDA approved, pulsatile, Berlin EXCOR to the continuous flow, Pediatric Jarvik 2000. Children included in this study must be >4kg and <15 kg and have 2 ventricle anatomy. The study should start late 2014 and high volume VAD centers will be the first to be randomized to the new device. One of the inclusion criteria for use of this device is that the child should be transplant eligible. (For more details on the PumpKIN trial, see the article by Janet Scheel.)

Planning for the Syncardia 50 cc Total Artificial Heart trial is underway and the study will have both a pediatric and adult arm. Meetings with the FDA have occurred and the HDE arm for pediatric patients is expected to start enrollment in October 2014. The trial design will be available in July and negotiation of clinical trial sites will begin at that time.

The next meeting that will have a strong VAD focus is the Pediatric Heart Failure Summit. This meeting is co-sponsored by Cincinnati Children's Hospital Medical Center, Texas Children's Hospital and Toronto Sick Kids. This year the meeting will be held in Cincinnati from September 11-13, 2014. There will be a pre-meeting symposium with hands on VAD training and an introduction to using simulation to educate staff and families about VAD troubleshooting. ■

Disclosure Statement: the author has no conflicts of interest to report.

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