I-Corps: Hematoma Reduction Compression Device and Wound Cosmesis Improvement in Patients Undergoing Cardiac Device Implants

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The broader impact/commercial potential of this I-Corps project is the development of an intervention that may improve patient safety and satisfaction and reduce healthcare costs for cardiac implantable electronic device (CIED) procedures. CIEDs are being implanted more frequently as patients are living longer with cardiac disease. Hematomas are a common complication following CIED implant procedures, occurring in up to 9% of patients. Most of these patients are on a combination of blood thinners, which further compounds the risk. Hematomas are not only painful and disfiguring for patients, but they are the greatest risk factor for developing CIED infections as they increase the risk of infection by 20-fold. CIED infection is associated with high morbiditiy/mortality with an upwards of $50,000 in healthcare costs per infection. With over 3 million CIEDs implanted annually worldwide, reducing hematomas and subsequent infection may result in healthcare savings and risk mitigation for the hospital. There is additional incisional scarring on the chest wall for patients requiring battery and generator exchange procedures occurring every 6-10 years. Improvements in wound healing and scar cosmesis may result in improved patient satisfaction and quality of life. This I-Corps project is based on the development of a non-invasive, externally applied, pneumatic compression device that reduces the incidence of hematomas and improves wound cosmesis for patients undergoing CIED implant procedures. The proposed device is applied post-operatively to the surgical site for 2-4 hours in the recovery room. The design is a pneumatic compression system that consists of a transparent air inflation mechanism with an inflatable surgical balloon and an air release valve. The compression system is fixated to the surgical site via four circumferentially applied adhesive pads. The balloon is inflated to ~40 mmHg, a pressure that has been well tolerated in a clinical trial and sufficient to combat venous pressure to reduce bleeding. The device’s transparent material allows for direct wound assessment during device wear.This award reflects NSF's statutory mission and has been deemed worthy of support through evaluation using the Foundation's intellectual merit and broader impacts review criteria.