SynCardia Certification Overview

Phase I – Introduction to the Total Artificial Heart

Location: SynCardia Regional Certification Center

Phase I consists of lectures, hands-on instruction with the SynCardia temporary Total Artificial Heart, drivers and patient simulator, and an animal implant surgery.

Phase II – Implant-Ready

Location: Trainee Hospital

Phase II prepares the surgical team for the first on-site Total Artificial Heart implant and certifies the center as implant-ready. Hospital drivers and the patient simulator are shipped so the implant team can practice and train other team members.

Phase III – Proctored 1st Implant

Location: Trainee Hospital

Phase III starts with the selection of an appropriate patient followed by the first implant, which is proctored by an experienced Total Artificial Heart surgeon.

Phase IV – Patient Discharge

Location: Trainee Hospital

Phase IV includes the training of hospital staff, patients and caregivers on discharge procedures with the driver. This includes driver operation, driveline dressing care, managing daily activities, physical therapy guidelines and daily monitoring of driver parameters and vital signs.

Multi-Disciplinary Approach

The members of the implant team will be responsible for one or more of the following key areas:

• Implant Surgery (surgeons)
• Surgery Support (scrub nurse or physicians assistant, perfusionist or anesthesiologist)
• Anticoagulation (hematologist, pharmacist or anesthesiologist)
• Driver Support (biomedical engineer, device coordinator or perfusionist)
• Post-Operative Patient Management (ICU nurse, nurse trainer or device coordinator)
• Heart Failure Cardiology (cardiologist or intensivist)
• Study Coordinator (if participating in a clinical study)
• Discharge Coordinator (device coordinator, transplant coordinator)