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Dr. Erik Hofman of the St. Antonius hospital oversaw their first trial of an innovative new flushing system, first tested at the Amsterdam UMC. This multicenter FLUID (FLUsh with Investigational Device) trial will verify the huge benefits this innovation can have in the care of post-operative heart patients.
“This is an exciting trial to be part of,”stated Dr. Hofman, when asked about St. Antonius’ involvement. “This technology promises to propel us into a new era of post-operative care and drainage to prevent complications.”
Blood-related complications following heart surgery have always been a big source of concern. An otherwise successful surgery might suddenly start to go wrong because of clotting or other complication. Adding to the concern and uncertainty is the fact that surgeons have lacked insight into how their patients are faring, post operation. This remarkable wound drainage technology promises to change all this.
Invented by Dr. David Koolbergen, a prominent heart surgeon at the Amsterdam Medical Centre (AMC), the investigational drainage device has been developed by Demcon and Haermonics, the start-up co-founded by Dr. Koolbergen to bring this promising solution to market. The device continuously flushes the space around the heart following surgery, while simultaneously providing medical staff with real-time data about the patient’s status.
St. Antonius is now the second of four medical centres that will be trialing the investigational device, after a successful trial start at the AMC. The St. Antonius hospital is especially notable in that it is one of the largest heart centers in the Netherlands. The expectation is that the trial will confirm the technology’s proven ability to drastically reduce or prevent such complications as atrial fibrillation and the need for blood transfusions or re-operations and, of course, a reduction in the number of days required in IC. In addition to validating expectations, data from the FLUID trial will be used in part for CE and FDA approval.
For many, the faster this technology can be made available the better. A big reduction in complications translates into big savings: by one estimate, €3.2 billion annually. Even more significant are the estimated savings in lives – each year, tens of thousands of heart-surgery patients die unnecessarily from post-surgery blood-related complications.