CLIENT TESTIMONIAL
Dr. Jeffrey W. Chambers, MD, FACC, FSCAI, Metropolitan Heart and Vascular Institute, Mercy Hospital, Minneapolis, Minnesota
Clinical and Health Economics Advantages
- 1 guidewire for the entire procedure
- No device exchange
- Predictable PCI Outcomes
Situation
Number of beds in hospital: 273
Cath lab staff description:
o 25 Employees
o 11 Physicians
Yearly PCI activity: ~1500 Cardiovascular procedures/year including PCI and peripheral interventions.
Background
The use of pressure guidewires to guide Percutaneous Coronary Interventions (PCI) is growing fast and quickly expanding to more complex lesions, especially now with more complex patients in need of complete revascularization. A new technology is now available and has made its way to our cath labs.
Clinical Experience
Pressure guidewires have been proven through multiple studies to improve PCI outcomes, mostly by providing a better diagnosis on coronary disease. The idea to measure coronary physiology post stenting isn’t new but the previous technologies have been the main limitations to be able to perform measurements pre and post stenting.
In fact, with traditional pressure guidewires we usually don’t stent over them or when we do, we often can’t reconnect it with reliability to get a post-PCI pressure measurement. Those additional manipulations lead to the use of multiple adjunct devices, several exchanges which make the cases longer, more costly and sometimes more risky¹.
Some other challenges include the inability to manipulate the pressure guidewire like a workhorse guidewire, the loss of precision – or drift – during the case, and the need to use adenosine to have a larger window to make the proper decision (.80 cutoff) vs. adenosine-free indices which require perfect accuracy (cutoff .89).
When we started to use the OptoWire™, which has the Fidela™ sensor embedded, all those limitations went away thanks to the accuracy of this second-generation fiber optic sensor and the concentric design of the guidewire which provide workhorse-like performance. Additionally, the unique disconnect/reconnect feature now allows us to perform the entire case without the need for adjunct devices or exchanges. With this new technology, we now cross the lesion, disconnect, and perform the PCI over the OptoWire to finally reconnect to get the post-PCI measurement and confirm a successful procedure. And thanks to the accuracy of the Fidela sensor, we are now mostly using the diastolic Pressure Ratio (dPR) which is an adenosine-free index that makes the case even faster and safer.
Financial Value
In our institution, clinical outcomes are our number one priority, but cost-effectiveness is second and we expect medical devices to evolve and provide better value.
With traditional pressure guidewires and their limitations, several adjunct devices were needed, and it was not a rare situation to have to use a second pressure guidewire to finish the case. When put together, those costs add up and can represent up to 30% of the costs of the pressure guidewire itself. Not to mention, several hundred dollars for adenosine and major investment in capital equipment are often required.
With the OpSens OptoWire, we now keep those additional costs under control: investment in capital equipment has been minimal, the accuracy of the device has seen a drastic reduction in the use of adenosine, and it is extremely rare to see the use of an adjunct device to deliver the OptoWire or conduct the PCI.
Finally, our staff has always been strong believers in post-PCI coronary physiology and thanks to this new technology, it is now becoming standard practice to measure post-PCI coronary physiology. The OptoWire supports our needs to meet our clinical objectives and reduce our 30-day readmissions.
Conclusion
Coronary physiology has been underutilized mostly because of the previous generation devices’ limitations. With the OpSens OptoWire, we now have a device that reduces our costs while offering the ability to offer coronary physiology to all our patients.
¹ ORBITA study, R. Al-Lamee et al, 4% bailout PCI due to piezoelectric pressure guidewires, The Lancet vol. 391, issue 10115, P31-40, JAN 06, 2018
