The safety and effectiveness of the Edwards SAPIEN Transcatheter Heart Valve were evaluated in a randomized, controlled pivotal study called The PARTNER Trial. This rigorous study established the clinical evidence necessary for FDA approval, making it available to patients with severe, symptomatic native aortic valve stenosis unable to undergo traditional open-heart surgery. The name of the trial signifies the important partnership between cardiac surgeons and interventional cardiologists who were brought together to collaborate in the evaluation, treatment and follow-up care of patients using a multi-disciplinary, Heart Team approach.
The partnership between the cardiac surgeon and interventional cardiologist establishes the core of the TAVR Heart Team – a care team comprised of specialists from various disciplines that work together to ensure optimal patient outcomes. This multi-disciplinary approach to patient care is essential in TAVR, as each specialist contributes an important area of expertise that plays an integral role in the collective care process.
Transcatheter Heart Valve Team
- The cardiac surgeon determines the most appropriate candidates for TAVR, and plays a critical role in ensuring optimal outcomes by offering their surgical expertise as needed during the transfemoral TAVR procedure.
- An interventional cardiologist (IC) works closely with a cardiac surgeon in the evaluation of potential candidates for TAVR. ICs perform transfemoral TAVR in a cardiac cath lab or hybrid operating room (OR) aided by imaging equipment to assist with optimal valve delivery and placement.
- An anesthesiologist is responsible for ensuring safe delivery of anesthesia before and during the procedure, monitoring the patient during the procedure and overseeing post-procedure care.
- An echocardiographer uses ultrasound technology to examine and evaluate the function of the heart including valve function and blood flow.
- The cath lab and OR staff assist with device as well as room preparation, and closely monitor the patient and procedure environment both during and after the procedure.