Abbott’s Resting Full-Cycle Ratio (RFR) Software Metric and other resting indices assess coronary stenosis severity without inducing hyperemia.
Abbott’s Resting Full-Cycle Ratio (RFR) Software Metric and other resting indices assess coronary stenosis severity without inducing hyperemia.
The RFR non-hyperemic index scans through diastole and systole for the largest drop in pressure over the entire cardiac cycle. RFR has been studied in over 3,500 lesions and 2,000 patients.2-6
When choosing RFR with the wireless PressureWire™ X Guidewire, users access the benefits of advanced wire technology and advanced patient security.
The RFR resting index measurement thresholds indicate that:2-4
In patients with multiple sequential stenoses or diffuse lesions, pullback pressure assessment can identify lesions with functional significance9. RFR can be calculated along the entire length of a stenotic vessel using pullback, which measures pressure gradient at any given location.
RFR is assessed using the new PressureWire™ X Guidewire — the world’s only wireless pressure wire1 — with a uniquely designed pressure sensor housing to reduce drift.
RFR clinical evidence derives from assessing over 3,500 lesions in 2,000 patients,2-6 and much of that evidence is outlined below from ILUMIEN I + PREDICT, VALIDATE RFR, IRIS-FFR and RE-VALIDATE RFR.
A retrospective analysis of data from historical studies (ILUMIEN I + PREDICT) comparing RFR to fractional flow reserve (FFR) concluded that RFR had 79.2% overall accuracy compared with FFR, similar to other non-hyperemic pressure ratios.2
Retrospective analysis of data from previous studies comparing RFR to iFR‡ (VERIFY 2,10 IRIS-FFR11) concluded that RFR is diagnostically equivalent to iFR‡ but unbiased in its ability to detect the lowest Pd/Pa during the full cardiac cycle. In addition RFR may potentially unmask significant coronary stenoses that would be missed by an assessment dedicated only to specific segments of the cardiac cycle.3
*RFR measurements made using genuine iFR waveforms performed with Philips wires (PrimeWire, Verrata) and proprietary software (Harvest).
IRIS-FFR is a large retrospective study (1,506 patients, 1,833 lesions) evaluating outcomes of resting indices; its median follow-up was 1.1 years. The analysis examined deferred lesion failure (DLF) among 5 resting indices—resting Pd/Pa, iFR‡, RFR, dPR‡ and DFR‡—and concluded that all resting indices had similar outcomes in deferred lesions.4
These results suggest a “class effect” among non-hyperemic pressure ratios. Guidelines and clinical recommendations can therefore be applied in the same manner.4
Physiological Measures
FFR-FRIENDS Substudy (435 patients, 1,024 vessels) showed RFR and iFR‡ had the same prognostic value in predicting vessel-oriented composite outcomes (VOCO)12
RE-VALIDATE RFR study (431 patients, 501 lesions) prospectively analyzed diagnostic performance between RFR and iFR‡ in a real-world patient population. The results13 demonstrated:
PPV = positive predicative value; NPV = negative predicative value
FFR = fractional flow reserve; iFR‡ = instantaneous wave-free ratio (during diastole); RFR = resting full-cycle ratio; dPR‡ = diastolic pressure ratio; DFR‡ = diastolic hyperemia-free ratio
1. Volcano Corp. Verrata‡ guidewire and PrimeWire Prestige‡ Plus guidewire IFUs, Opsens Inc. OptoWire‡ guidewire and OptoWire‡ II guidewire IFUS, ACIST Medical Systems. Navvus‡ Microcatheter IFU, Boston Scientific Corporation. Comet‡ guidewire IFU, PressureWire™ X guidewire IFU.
2. Jeremias A, et al. Resting full-cycle ratio (RFR): a novel physiologic index compared to Fractional Flow Reserve (FFR) in assessing the hemodynamic severity of a coronary stenosis: ILUMIEN I + PREDICT. EuroPCR 2018.
3. Svanerud J, et al. Validation of a novel non-hyperaemic index of coronary artery stenosis severity: the Resting Full-cycle Ratio (VALIDATE RFR) study. EuroIntervention. 2018;14:806-814.
4. Ahn JM, et al. IRIS FFR: prognostic performance of five resting pressure-derived indexes of coronary physiology. TCT 2018.
5. Data on file at Abbott.
6. Lee J-M, et al. Physiological and clinical assessment of resting physiological indexes. Circulation. 2019;139.
7. Compared to the previous generation (PressureWire™ 8 Guidewire); Abbott data on file.
8. Compared to the previous generation QUANTIEN™.
9. Nam CW, Koo BK. Fractional flow reserve assessment of serial lesions. Radcliffe Cardiology. April 2014.
10. Hennigan B, et al. Discordance between resting and hyperemic indices of coronary stenosis severity: the VERIFY 2 study. Circ Cardiovasc Interv. 2016;9:e004016.
11. Ahn JM, et al. Fractional flow reserve and cardiac events in coronary artery disease: data from a prospective IRIS-FFR registry. Circulation. 2017;135:2241–2251.
12. Lee J-M, et al. Clinical implications of three-vessel fractional flow reserve measurement in patients with coronary artery disease. Eur Heart J. 2018;39(11):945-951.
13. Kumar G, et al. RE-VALIDATE: REal world VALIDATion of the non-hyperemic InDex of coronary Artery sTEnosis severity: resting full-cycle ratio (RFR) – RE-VALIDATE RFR. CRT 2019.
The QUANTIEN™ Measurement System is indicated to provide hemodynamic information for use in the diagnosis and treatment of coronary or peripheral artery disease.
The QUANTIEN™ Measurement System is intended for use in catheterization and related cardiovascular specialty laboratories to compute, and display various physiological parameters based on the output from one or more electrodes, transducers, or measuring devices.
The device has no patient alarm functions. Do not use it for cardiac monitoring.
The PressureWire™ X guidewire is indicated to direct a catheter through a blood vessel and to measure physiological parameters in the heart and in the coronary and peripheral blood vessels. Physiological parameters include blood pressure. The PressureWire™ X guidewire can also measure blood temperature.
This guidewire is contraindicated for use in the cerebral vasculature.
Potential complications which may be encountered during all catheterization procedures include, but are not limited to: acute myocardial infarction or unstable angina, allergic reaction to the contrast media, arterial dissection, injury, or perforation, cardiac arrhythmias, coronary artery spasm, embolism, thrombus formation, or death.
AP2947437-WBU Rev. B
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Unless otherwise specified, all product and service names appearing in this Internet site are trademarks owned by or licensed to Abbott, its subsidiaries or affiliates. No use of any Abbott trademark, trade name, or trade dress in this site may be made without the prior written authorization of Abbott, except to identify the product or services of the company.
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