Dr. Robert Guidoin, Professor, Department of Surgery, Faculty of Medicine, Université Laval, Canada

Speech Title: Cardiovascular Devices For Implantology: How The 3bs Concept Contributes To The Culture Of Safety

Abstract: The development of myriads of innovative implantable devices during the last decades proved to be mostly physician and industry driven. The clinicians continue to require more and more sophisticated devices to restore various functionalities and allow more and more patients with complex and sometimes life threatening pathologies to be treated. Thus the life of the patients is prolonged and made more comfortable.

Despite widespread efforts among healthcare organizations to improve patient safety, the adverse events still occur too frequently and the ways to prevent them are still poorly understood and poorly quantified. A safety culture encourages the identification of these adverse events thereby reducing risks as well as preventing harm. Adverse events might be caused by the patient’s health deterioration, the inappropriate selection of the devices implanted, the environment and/or an inadequate surgical technique. Developing a culture of safety in a health organization represents a formidable challenge. As the implantology brings innovative treatments for myriads of patients and clinicians, the outcomes require continuous assessment, more specifically in a era of disruptive technologies

Those developed for cardiovascular treatments such as percutaneous valves, stent-grafts, leadless pacemakers are in high demand by patients who are livinglonger, and who do not want to be exposed to open surgery with the attendant prolonged stay in hospitals.

As patients are increasingly aware of what implantalogy is about, they no longer accept to be passive recipients of surgical interventions. They wish to become active participants in any surgical decision, from implantation to follow up. The time they were solely processed is over.

Therefore each step in the implantology process must be explained to and understood by the patient. Adverse events that are device related will likely be history if implantology relies on devices that integrate the 3Bs concept: biofunctionality, biodurability and biocompatibility. The biofunctionality is the first key issue to be addressed as more and more patients require customized devices. Most attention is paid to the early and midterm performance as it generates new ideas that contribute to future development of new devices. Most implanted devices have not yet achieved the long-term durability that exceeds the life expectancy of many patients. In addition, the biocompatibility characteristics of the implant are rarely addressed because they integrate numerous phenomena related to the continuous interaction between the host and the foreign materials. As the result of these interaction, the implants and their environment are continuously remodeled by a process that transforms a foreign body alien to the patients into a composite device incorporating various tissue components. As stated by the Patient Safety Movement: “What is measured gets managed”. The adherence to the 3Bs rule should contribute to a decrease in and possibly elimination of adverse device related events.

Keywords: Cardiovascular devices, patient safety, biofunctionality, biodurability, biocompatibility