CARDIOVASCULAR

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Abbott’s Resting Full-Cycle Ratio (RFR) Software Metric and other resting indices assess coronary stenosis severity without inducing hyperemia.

RFR IS MEASURED WITH THE WORLD’S ONLY WIRELESS PRESSURE WIRE¹: PRESSUREWIRE™ X GUIDEWIRE

HOW DOES RFR WORK?

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

RFR™ resting index finds lowest Pd/Pa in entire cardiac cycle

WHY CHOOSE RFR

When choosing RFR with the wireless PressureWire™ X Guidewire, users access the benefits of advanced wire technology and advanced patient security.

ADVANCED WIRE TECHNOLOGY

Uniquely designed sensor housing for
improved drift performance⁷
Wireless design optimal for procedures using
radial approach

ADVANCED PATIENT SECURITY

Enhanced login and encryption features⁸
Wireless signal uses advanced frequency-hopping spread spectrum (FHSS) technology that changes radio frequency 400 times per second

RFR MEASUREMENT THRESHOLDS

The RFR resting index measurement thresholds indicate that:^2-4

When RFR ≤ 0.89, treatment with PCI may be beneficial
When RFR > 0.89, deferral of PCI may be beneficial

ASSESSING SERIAL LESIONS WITH RFR

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 USED WITH PRESSUREWIRE™ X GUIDEWIRE AND QUANTIEN™ MEASUREMENT SYSTEM

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.

PRESSUREWIRE™ X GUIDEWIRE

RFR is available with the QUANTIEN™ System.

QUANTIEN™ SYSTEM

RFR OUTCOMES DATA

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.

ILUMIEN I + PREDICT

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

VALIDATE RFR

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

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}

Pd/Pa and resting indices iFR, RFR™, dPR and DFR had similar outcomes in deferred lesions

3V FFR-FRIENDS

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

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:

Real-world evidence that RFR is diagnostically equivalent to iFR^‡
That compared to iFR^‡, the RFR resting index achieved high diagnostic accuracy, sensitivity, specificity and AUC (the area under the ROC curve)

Diagnostic Performance of RFR vs iFR^‡

_{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

REFERENCES

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.

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IMPORTANT SAFETY INFORMATION

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QUANTIEN™ Measurement System

INDICATIONS

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.

CONTRAINDICATIONS

The device has no patient alarm functions. Do not use it for cardiac monitoring.

WARNINGS

No modification of this equipment is allowed.
Do not open or remove access covers on the QUANTIEN™ Measurement System unless specifically instructed by technical support to do so.
External equipment intended for connection to signal input, signal output or other connectors, shall comply with relevant IEC standard (e.g., IEC 60601 series for medical electrical equipment). In addition, all such combinations of systems shall comply with the standard IEC 60601-1-1, Safety requirements for medical electrical systems, alternatively IEC 60601-1 ed.3 §16, ME SYSTEMS. Any person who connects external equipment to signal output, or other connectors, has formed a system and is therefore responsible for compliance of the system with these requirements. If in doubt, contact a qualified technician, or alternatively, your representative or technical support.
Do not use the QUANTIEN™ Measurement System if it has been dropped or in any other way exposed to mechanical or electrical damage. This can cause the user or patient to be exposed to electric shock or cause faulty readings of data. Contact your representative or technical support for further instructions.
Do not use the QUANTIEN™ Measurement System if there is reason to believe the system's security has been compromised or if the system was unaccounted for a period of time (i.e. misappropriated, modified or tampered with).
High frequency surgical equipment must not be used on a patient at the same time as PressureWire™ Guidewire and the QUANTIEN™ Measurement System.
Do not use the QUANTIEN™ Measurement System if liquid is suspected to have penetrated the enclosure or the power supply unit. This can cause the user or patient to be exposed to electric shock. Contact your representative or technical support for further instructions.
Do not sterilize the QUANTIEN™ Measurement System or any of its parts. Do not use this system or any of its parts if it has been sterilized.
The QUANTIEN™ Measurement System contains a lithium battery for the system real-time clock. Danger of explosion. Battery is not intended to be replaced.
Do not leave the QUANTIEN™ Measurement System unattended when logged in as a Site Administrator.
To protect the privacy and security of sensitive information, including electronic protected health information (EPHI), and to protect the integrity of the system itself, the system should be located in a physically secure, access controlled environment.

PRECAUTIONS

The QUANTIEN™ Measurement System is Type CF equipment and protected against the effects of a discharge of a defibrillator. PressureWire™ Guidewire readings may be affected by defibrillation. After defibrillation restart procedure, i.e. re-zero and re-equalize PressureWire™ Guidewire.
If it is necessary to install the QUANTIEN™ Measurement System adjacent to other equipment, this system should be observed to verify normal operation. If abnormal performance is observed, it is necessary to increase distance between equipment.

PressureWire™ X Guidewire

INDICATIONS

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.

CONTRAINDICATIONS

This guidewire is contraindicated for use in the cerebral vasculature.

WARNINGS

No modification of this device is allowed.
The PressureWire™ X guidewire is supplied sterile. Discard the guidewire if the pouch is opened or damaged, compromising the sterile barrier. The guidewire is designed for single use only and shall not be reused or resterilized. Adverse effects of using a non-sterile or resterilized guidewire may include, but are not limited to:
- Local and/or systemic infection
- Mechanical damage
- Inaccurate readings
Observe all guidewire movements. Whenever the guidewire is moved or torqued, the tip movement should be examined under fluoroscopy. Never push, withdraw, or torque the guidewire if it meets resistance or without observing corresponding movement of the tip, otherwise vessel/ventricle trauma may occur.
Torquing or excessive manipulation of the guidewire in a sharp bend, against resistance, or repeated attempts to cross a total vessel occlusion may:
- Cause dissection or perforation of blood vessels
- Cause vessel spasm
- Damage and/or fracture the guidewire
When introducing the guidewire, flush the catheter and administer anticoagulation as for a standard catheterization procedure or clotting may occur.
Do not use the guidewire in the ventricles if the patient has a prosthetic mechanical or biological valve. It may result in damage to both the prosthesis and the guidewire, which may cause injury or death.
Use of the PressureWire™ X guidewire in conjunction with interventional devices with a short rapid exchange may result in a folded or fractured guidewire.
High frequency surgical devices must not be used on a patient at the same time as the guidewire.

PRECAUTIONS

The PressureWire™ X guidewire is a delicate instrument and should be handled carefully.
Make sure that the transmitter is kept dry to ensure accurate pressure and/or temperature readings. Inaccurate readings may necessitate device replacement.
Do not use the guidewire in conjunction with atherectomy catheters. It may damage the guidewire.
Do not withdraw or manipulate the guidewire in a sharp-edged object. It may result in abrasion of the guidewire coating.
Factors that may affect the accuracy of the diagnostic information include, but are not limited to:
- Improper placement of the aortic pressure sensor.
- Failure to achieve maximum coronary and myocardial hyperemia.
- Blood flow affected by the position of interventional devices, such as balloon catheters.
Guidewire readings may be affected by defibrillation. Rezero the guidewire after defibrillation use.
Do not measure pressure when the guidewire sensor element is in a sharp bend or in contact with atrial or ventricular walls. It might result in pressure artifacts.
Do not use the PressureWire™ X guidewire together with another guidewire, for so called jailed wire technique, due to difficulty in guidewire withdrawal and possible guidewire entrapment.
Store at room temperature in a dry and dark place.

POTENTIAL ADVERSE EVENTS

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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The following pages are intended for medical professionals and provide information on the proper use of products (medical devices, etc.) of Abbott Medical Japan GK.

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RFR WITH PRESSUREWIRE™ X GUIDEWIRE:

THE ADVANCED SOLUTION

RFR IS MEASURED WITH THE WORLD’S ONLY WIRELESS PRESSURE WIRE¹: PRESSUREWIRE™ X GUIDEWIRE

HOW DOES RFR WORK?