The PressureWire fractional flow reserve measurement system for coronary artery disease

Evidence comes from 3 large multicentre randomised controlled trials, 1 single centre randomised controlled trial and 1 large register.

Three systematic reviews, 4 randomised controlled trials and 1 large cohort study indicate that the PressureWire devices can be effective as adjuncts to coronary angiography to identify functionally significant stenosis.

In patients with stable coronary artery disease and fractional flow reserve (FFR) of less than 0.8, outcomes were better for FFR-guided percutaneous coronary intervention (PCI) than for medical treatment alone.

An FFR-guided strategy, compared with an angiography-guided approach, resulted in no statistically significant difference in relative risk reduction for major adverse cardiac event outcomes.

In 1 randomised controlled trial, major adverse cardiac events were significantly improved by FFR-guided PCI at 1 year, but the difference was not significant at 2 years. There were significantly fewer myocardial infarction events in the FFR-guided PCI group at 2 years than in the angiography group.

The PressureWire Aeris costs £598.80 and PressureWire Certus (with Agile tip) costs £499. Each PressureWire FFR device is single use.

Four economic analyses evaluated FFR guided-strategies using the PressureWire FFR devices, but no published economic analyses based in the UK were identified.

PressureWire FFR devices are used by interventional cardiologists in a cardiac catheterisation laboratory setting.

The PressureWire Certus device is used with the Quantien proprietary monitor unit (St Jude Medical), purchased separately; the PressureWire Aeris device uses wireless transmission to a receiver unit connected to monitoring platforms with FFR capability.