SYSTEMS AND METHODS FOR DETERMINING FRACTIONAL FLOW RESERVE WITHOUT ADENOSINE OR OTHER PHARMALOGICAL AGENT

摘要

Embodiments hereof relate to methods and systems for determining a pressure gradient across a lesion of a vessel without requiring the use of a pharmacological hyperemic agent. A measurement system includes at least an injection catheter and a pressure-sensing instrument or guidewire slidingly disposed through the catheter, the pressure-sensing guidewire including at least one pressure sensor configured to obtain a pressure measurement for use in determining the pressure gradient across the lesion. The catheter is configured to deliver or inject a non-pharmacological fluid, such as saline or blood, across the lesion in order to increase a flow rate there-through, thereby simulating hyperemia without the use of a pharmacological hyperemic agent. Once an increased flow rate that simulates hyperemia is achieved, the pressure sensor of the pressure-sensing guidewire may be utilized to measure the pressure gradient across the lesion in order to assess the severity of the lesion.

主权项

1. A method of determining a pressure gradient across a lesion of a vessel, the method comprising the steps of:
percutaneously delivering a pressure-sensing instrument having at least a first pressure sensor at a distal portion thereof through a vasculature until the first pressure sensor is positioned adjacent to and distal to the lesion; distally advancing a catheter over the pressure-sensing instrument via a first lumen of the catheter until a distal end of the catheter is positioned adjacent to and proximal to the lesion; injecting a non-pharmacologic fluid through a second lumen of the catheter and across the lesion, wherein injection of the non-pharmacologic fluid increases a flow rate across a portion of the vessel including the lesion; measuring a distal pressure measurement at a location distal to the lesion with the first pressure sensor of the pressure-sensing instrument, wherein the step of obtaining the distal pressure measurement occurs while the flow rate across the lesion is increased; and using the distal pressure measurement and a proximal pressure representative of the pressure at a location proximal to the lesion to determine the pressure gradient across the lesion.