CARDIOVASCULAR
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Why Physiology | Abbott’s Portfolio | Drift | Pressure Ratios Landscape | Clinical Outcomes

Physiological measurements, also known as hyperemic and non-hyperemic pressure ratios (NHPR), are used to evaluate the functional significance of coronary stenosis. There are several hyperemic and NHPRs available to an interventional cardiologist today as well as wires and other tools to support coronary physiology needs.

 

Watch physician experts discuss the important factors to look for when measuring coronary physiology and explain why technique and the right tools matter.

 

What are the key trends and takeaways in coronary physiology adoption?
Do we need a clinical outcomes trial for resting indices?
The importance of technique and how it impacts coronary measurements

PHYSIOLOGY-GUIDED DECISION MAKING LEADS TO BETTER OUTCOMES2,3

  • Coronary angiography is not accurate in 34% of cases compared to FFR1
  • Physiology-guided PCI resulted in improved outcomes2,3
  • FFR-guided PCI reduces MI compared to medical therapy alone4
  • All NHPR, including RFR, have similar outcomes and diagnostic performances3

 

ABBOTT’S CORONARY PHYSIOLOGY PORTFOLIO

Abbott’s Physiology portfolio includes Resting Full-Cycle Ratio (RFR), Fractional Flow Reserve (FFR), and PressureWire™ X Guidewire.


 

RFR - RESTING FULL-CYCLE RATIO

RFR is now approved to be added to NCDR by ACC as equivalent to iFR.5-6

RFR scans through diastole and systole for the largest drop in pressure in the entire cardiac cycle.
RFR has been studied in over 3,500 lesions and 2,500 patients7-10 to show diagnostic equivalence to iFR.11


 

FFR - Fractional Flow Reserve

FFR is a ratio of the (Pd) distal to the lesion coronary pressure divided by (Pa) aortic pressure proximal to the stenosis during maximal hyperemia.
FFR measured by the PressureWire™ X Guidewire is a risk stratification tool that helps guide revascularization, as seen in the FAME and FAME 2 trials.4

 


 

PRESSUREWIRE™ X GUIDEWIRE

PressureWire™ X Guidewires offer objective decisions with a simplified workflow. The new innovative sensor housing design of PressureWire™ X Guidewire has technology to improve12 measurement accuracy.

 

Previous Sensor Housing Design

NEW Sensor Housing Design


 

RFR is recognized by the Appropriate Use Criteria with an approved coding recommendation by ACC/SCAI.


 

MULTIPLE CONNECTION OPTIONS OFFER STRESS FREE CONNECTIVITY

PressureWire™ X Guidewire is the only wire with 4 connection options to eliminate clutter and meet your labs needs.

OBJECTIVE DECISION MAKING: DRIFT MATTERS

Drift is a phenomenon that affects the accuracy of most pressure measurement devices.13 Accuracy is particularly critical for resting ratios, as clinical decisions from resting ratios are more impacted by drift than FFR.14,15

the effect of drift on stenosis misclassification by physiology index
The distribution of values for FFR, IFR and whole-cycle PD/PA

Compared to the hyperemic state, smaller separation between Pd and Pa at rest means even relatively small amounts of drift can lead to stenosis misclassification compared to FFR. That’s why it critical to detect even the slightest difference of pressure.

PHYSIOLOGICAL PRESSURE RATIOS LANDSCAPE

Physiological pressure ratios landscape

 

FFR = fractional flow reserve
iFR = instantaneous wave-free ratio (Philips)
RFR = resting full-cycle ratio (Abbott)

 

EQUIVALENCE AND DIFFERENCES IN RESTING INDICES

 

What data supports equivalent outcomes?

IRIS-FFR is a large retrospective study (n = 1,506 patients, 1,833 lesions) evaluating outcomes of resting ratios; 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.14

These results suggest a “class effect” among non-hyperemic pressure ratios. Guidelines and clinical recommendations can therefore be applied in the same manner.14

 

How equivalent are resting (non-hyperemic) indices?

 

  Pd/Pa Full
Cycle Average
Diastolic
Pressure Ratios
RFR
Full Cycle
Accuracy vs. FFR1 85% 83% 84%
Cutoff ≤0.91 ≤0.89 ≤0.89
Hyperemia Needed1 No No No
Clinical Decision Making1 Equivalent
Outcomes1 Equivalent
Pullback Sensitivity2 Medium High High

1. Ahn, JM., et al. IRIS-FFR: prognostic performance of five resting pressure-derived indexes of coronary physiology. TCT2018.
2. Nijer, S., et al. The Instantaneous wave-Free Ratio (iFR) pullback: a novel innovation using baseline physiology to optomise coronary angioplasty in tandem lesions. Cardiovascular Revascularization Medicine, 2015.

 

 

When to use hyperemic vs non-hyperemic index?

 

  Non-Hyperemic Hyperemic
Multi-vessel Disease1 +++ +++
LMCA2 - +++
LAD3 +++ ++
Tandem Lesions4 +++ +
Diffuse Disease5 +++ +
ACS6 +++ ++
DM7 +++ +++
Systolic Dysfunction8 - +++
Post-PCI SB Interrogation9 - +++
Post-PCI Assessment10 - +++

1. Eur Heart J. 2017 Nov 7;38(42):3124-3134. 2. Catheter Cardiovasc Interv. 2015 Jul;86(1):12-8. 3. JACC 2019 Feb 5;73(4):444-453. 4. JACC Int 2014 Dec;7(12):1386-96. 5. Define PCI ACC 2019. 6. JACC Int 2018 Aug 13;11(15):1437-1449. 7. JAMA Cardiol 2019 Jul 17. 8. Eur Heart J. 2019 Aug 16. 9. JACC 2005 Aug16;46(4):633-7. 10. JACC 2014 Oct 21;64(16):1641-54.

Chart courtesy of Ziad Ali, MD.

 

ABBOTT'S LEGACY OF LEADERSHIP IN CORONARY PHYSIOLOGY

As a leader in PCI, Abbott also has a rich legacy of supporting research, developing products and advancing technology related to coronary physiology. Abbott’s accomplishments offer interventional cardiologists key data as well as cutting-edge technology.

Abbott's legacy of leadership in coronary physiology

References

  1. Park, SJ., et al. Visual-functional mismatch between coronary angiography and fractional flow reserve. JACC Interv. (2020) 5:10.
  2. Pijls, N., et al. 2-year follow-up of the FAME (Fractional Flow Reserve Versus Angiography for Multivessel Evaluation) study. JACC Vol. 56, No. 3, 2010.
  3. Ahn JM, et al. IRIS FFR: prognostic performance of five resting pressure-derived indexes of coronary physiology. TCT 2018.
  4. Xaplanteris, P., et al. Five-Year Outcomes with PCI Guided by Fractional Flow Reserve. NEJM. May 22, 2018.
  5. ACC addressing the need for RFR reporting in CATHPCI registry. March 11, 2020. ACC.
  6. Correction. ACC/AATS/AHA/ASE/ASNC/SCAI/SCCT/STS 2017 Appropriate Use Criteria for Coronary Revascularization in Patients With Stable Ischemic Heart Disease. https://doi.org/10.1016/.
  7. 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.
  8. 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.
  9. Data on file at Abbott.
  10. Lee J-M, et al. Physiological and clinical assessment of resting physiological indexes. Circulation. 2019;139.
  11. 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.
  12. Test(s) performed by and data on file at Abbott.
  13. Jeremias, A., et al. A Test in Context: FFR: Accuracy, Prognostic Implications, and Limitations. JACC 2017; 69:2748-58.
  14. Van’t Veer, M, et al. JACC. Comparison of Different Diastolic Resting Indexes to iFR. 70 (25), 2017.
  15. Cook, C. CCI. Quantification of the Effect of Pressure Wire Drift on the Diagnostic Performance of FFR, iFR, & Pd/Pa.
Request Abbott Sales Rep IMPORTANT SAFETY INFORMATION

IMPORTANT SAFETY INFORMATION

rx-only-logo OPTIS™ Imaging Systems and Software

INDICATIONS

The OPTIS Integrated System and Mobile System with OPTIS Software combined with Dragonfly™ DUO or Dragonfly™ OPTIS™ Imaging Catheter are intended for the imaging of coronary arteries and are indicated in patients who are candidates for transluminal interventional procedures. The Dragonfly DUO or Dragonfly OPTIS Imaging Catheter are intended for use in vessels 2.0 to 3.5 mm in diameter. The Dragonfly DUO, or Dragonfly OPTIS Imaging Catheter is not intended for use in the left main coronary artery or in a target vessel which has undergone a previous bypass procedure.

The OPTIS Integrated System and Mobile System will further acquire radio frequency signal outputs from both a distal intracoronary pressure transducer and a proximal aortic pressure transducer to determine the physiological parameter, Fractional Flow Reserve (FFR). The physician may use the FFR parameter, along with knowledge of patient history, medical expertise and clinical judgment to determine if therapeutic intervention is indicated.

CONTRAINDICATIONS

The OPTIS Integrated System and Mobile System with OPTIS Software are contraindicated where introduction of any catheter would constitute a threat to patient safety. Contraindications include:

  • Bacteremia or sepsis
  • Major coagulation system abnormalities
  • Patients diagnosed with coronary artery spasm
  • Patients disqualified for CABG surgery
  • Patients disqualified for PTCA
  • Severe hemodynamic instability or shock
  • Total occlusion
  • Large thrombus
  • Acute renal failure

NOTE: The systems have no patient alarm functions. Do not use for cardiac monitoring.

WARNINGS

  • Appropriate anticoagulant and vasodilator therapy must be used during the procedure as needed.
  • Observe all advancement and movement of the Dragonfly Imaging Catheter under fluoroscopy. Always advance and withdraw the catheter slowly. Failure to observe device movement fluoroscopically may result in vessel injury or device damage.
  • Leave the guidewire engaged with the catheter at all times during use. Do not withdraw or advance the guidewire prior to withdrawing the catheter.
  • If resistance is encountered during advancement or withdrawal of the Dragonfly Imaging Catheter, stop manipulation and evaluate under fluoroscopy. If the cause of resistance cannot be determined or mitigated, carefully remove the catheter and guidewire together.
  • The catheter should never be forced into lumens that are narrower than the catheter body or forced through a tight or heavily calcified lesion.
  • The catheter should not be advanced through abnormally tortuous anatomy.
  • When advancing or retracting a catheter with a minirail tip through a stented vessel, the catheter may engage the stent between the junction of the catheter and guidewire, resulting in entrapment of catheter/guidewire, catheter tip separation, and/or stent dislocation.
  • Refer to the contrast media’s instructions-for-use for general warnings and precautions relating to use of the contrast media.

PRECAUTIONS

  • Safety and effectiveness have been established for the following patient population: adult patients undergoing non-emergent percutaneous coronary interventions in lesions with reference vessel diameters between 2.0 to 3.5 mm, which were not located in the left main coronary artery or in a target vessel which has undergone previous bypass procedures.
  • All operators must be trained prior to using the OPTIS Integrated System, the OPTIS Mobile System and the Dragonfly Imaging Catheter.
  • Only 100% contrast media is approved for human use.
  • Store the catheter at ambient temperature in a dry location out of direct sunlight.
  • Never attempt to attach or detach a catheter to the DOC while the “lock” LED is lit.
  • Do not kink, sharply bend, pinch, or crush the catheter at any time.
  • The catheter is for single use only. Do not reuse, re-sterilize, or reprocess.
  • The catheter is sterilized by ethylene oxide and is intended for one time use only. Non-pyrogenic. Do not use if the package is opened or damaged.
  • After use, the catheter may be a potential biohazard. Handle and dispose of in accordance with accepted medical practice and applicable laws and regulations.
  • The catheter has no user serviceable parts. Do not attempt to repair or alter any part of the catheter assembly as provided.

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.

Caution: This product is intended for use by or under the direction of a physician. Prior to use, reference the Instructions for Use provided inside the product carton (when available) or at eifu.abbottvascular.com or at manuals.sjm.com for more detailed information on Indications, Contraindications, Warnings, Precautions and Adverse Events.

 

rx-only-logo QUANTIEN™ Measurement System

INTENDED USE

The QUANTIEN™ 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.

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™ system unless specifically instructed by St Jude Medical 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.
  • Do not use the QUANTIEN 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.
  • High frequency surgical equipment must not be used on a patient at the same time as PressureWire™ guidewire and the QUANTIEN system.
  • Do not use the QUANTIEN 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.
  • Do not sterilize the QUANTIEN system or any of its parts.
  • Do not use this system or any of its parts if it has been sterilized.
  • The QUANTIEN system contains a lithium battery for the system real-time clock. Danger of explosion. Battery is not intended to be replaced

PRECAUTIONS

  • The QUANTIEN™ 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 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.

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.

Caution: This product is intended for use by or under the direction of a physician. Prior to use, reference the Instructions for Use provided inside the product carton (when available), at eifu.abbottvascular.com or at Manuals.sjm.com for more detailed information on Indications, Contraindications, Warnings, Precautions and Adverse Events

 

rx-only-logo 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: vessel dissection or occlusion, perforation, embolus, spasm, local and/or systemic infection, pneumothorax, congestive heart failure, myocardial infarction, hypotension, chest pain, renal insufficiency, serious arrhythmias, or death.

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