VitalFlap

For many women, part of breast cancer treatment includes reconstructive breast surgery after the tumor is removed. Complex surgical methods - so called flap reconstruction - are used to achieve this. The (DIEP) flap procedure has become a routine procedure in reconstructive breast surgery. Due to advanced microsurgical techniques flap viability has improved significantly. Nevertheless, the failure of flaps due to problems at the site of the anastomosis still occurs in 6% to 25% of cases. The most critical period is usually the first 48 hours post-surgery, with salvage rates of 50% depending on the circumstances. The time interval between onset and surgical repair of a microvascular problem largely influences the success of re-procedure. Detecting first signs of postoperative flap failure is vital so that timely surgical re-exploration can be done to minimise damage to the flap and reduce the chance of flap failure. The predominant method for monitoring the reconstructed breast is clinical observation done by trained nurses on hourly intervals for the first few postoperative recovery days. However, this method is highly subjective and it is impossible for the hospital staff to observe the flap continuously.

Our solution will continuously monitor the breast vitality and warn medical staff timely for impending damage - even before it becomes clinically noticeable. This device is based on near infrared spectroscopy (NIRS), which is a well-known, non-invasive technology used in pulse oximeters. By measuring light absorbance, oxygenated haemoglobin concentration can be derived which indirectly reflects the status of tissue perfusion. By comparing these signals from the tissue of the reconstructed breast with a reference signal, a statement can be made about the flap’s vitality. This innovation will therewith replace the intensive schedule of hourly inspections by specialized nursing staff reducing workload and associated costs. Moreover, because the monitoring is carried out unnoticed and automatically, the patient is less frequently disturbed (especially during night hours) influencing recovery positively. Most importantly the innovation decreases the chance of flap failure and its associated psychological impact.