More than 1,000 systems have been activated with Volcano’s instant wave-Free Ratio, or iFR modality software, allowing physicians and patients around the globe to benefit from a simplified workflow and a reduced need for hyperaemic agents.
The iFR modality is a physiologic measurement performed using the same pressure wires and equipment utilised in cardiac catheterisation labs for fractional flow reserve, but avoids injection of hyperaemic agents into the patient that induce stress to the heart. This allows for a meaningful, lesion-specific assessment in seconds by amplifying the resting pressure waveform. The iFR modality can be used with Volcano’s Verrata pressure guide wire, which is designed for simple disconnection and reattachment during a procedure and multiple quick measurements without the need for hyperaemic agents.
“We believe that coronary physiology, of any kind, provides tremendous value to help drive appropriate therapy in patients,” comments Andrew Tochterman, director and functional management segment leader at Volcano. “As a result, technologies like iFR that remove the extra time and cost of hyperaemia, have the potential to increase adoption of coronary physiology and further optimise patient care.”
The iFR modality and other physiologic guidance tools including fractional flow reserve and coronary flow reserve, are currently being studied in numerous prospective clinical trials as part of the DEFINE family of studies. These studies are designed to explore patient outcomes in a broad array of clinical presentations in more than 5,000 patients worldwide. The performance of the iFR modality has been tested in approximately 800 patients as part of ADVISE (Adenosine vasodilator independent stenosis evaluation) II, the first prospective, real world registry comparing iFR and fractional flow reserve.
The iFR hybrid approach analysis performed in the ADVISE II study demonstrated a statistically high correlation (sensitivity 90.7% for fractional flow reserve less than or equal to 0.80, specificity 96.2% for fractional flow reserve greater than 0.80). The hybrid method would have avoided the need to use a hyperaemic agent in 65.1% of this patient population. Patients in ADVISE II were recruited from more than 40 centres in the USA and Europe, and all procedures were performed with operators blinded to the iFR values which were calculated offline at an independent core laboratory in Rotterdam, Netherlands.
“In our subset of patients thus far, we’ve seen more than a 60% reduction in the need for hyperaemic agents using the iFR hybrid approach, which is consistent with the ADVISE II study. Our patients appreciate not having to receive a hyperaemic agent but still receive the benefits of intracoronary physiologic measurements,” says Vincent J Pompili, director, interventional cardiovascular medicine and cardiac catheterisation laboratories at the Ross Heart Hospital at the Ohio State University Wexner Medical Center.