Same Device, Different Hands: Testing Embolic Protection in TAVR and TEVAR
A single-device concept was being considered for two very different procedures, each carried out by a different specialist. To get useful feedback, the recruit had to cover both.
A manufacturer was developing a single-vessel cerebral embolic protection device and wanted to understand where it might fit during transcatheter aortic valve replacement (TAVR) and thoracic endovascular aortic repair (TEVAR).
Different specialists usually perform these procedures, so the sample was split by procedure:
Five interventional cardiologists doing TAVR, all current users of an existing embolic protection device and treating at least two TAVRs a month
Six vascular surgeons doing TEVAR, all at least familiar with the existing device, for example, through colleagues or demonstrations
One cardiovascular surgeon doing both
The interventional cardiologists reported an average of 120 TAVRs a year. Respondents worked across public, private and university hospitals.
Each physician took part in a 45-minute, audio-only Zoom interview and reviewed a product profile and configuration diagrams.
Splitting the recruit by procedure proved essential. Interventional cardiologists explained that placing the device in the left common carotid artery would require a surgical cut-down they are not trained to perform, which suggested limited use in TAVR. The vascular surgeons provided the TEVAR perspective needed to assess the potential there.
Requiring current device use among TAVR operators also meant comparisons with existing practice came from first-hand experience.
A small, targeted sample gave the client an early read on fit and feasibility before further development.
