FRACTIONAL FLOW RESERVE STANDARDIZED Measure Accurately 1,2 with PressureWire Guidewire
Standardization of FFR STEP-BY-STEP PROCEDURE FOR PRESSUREWIRE GUIDEWIRE FFR is considered the reference standard for the evaluation of ischemic stenosis and the expected benefit from revascularization. 3 The FFR standardization publication from Toth et al., 2016 in Journal of the American College of Cardiology proposed a standardized way of acquiring, recording and interpreting FFR in daily practice to ensure accurate and reproducible measurements. FFR AT MAXIMUM HYPEREMIA IS THE GOLD STANDARD FOR ACCURACY 4 Diagnostic Accuracy 100% FFR (IV/IC Adenosine * ) - Standard of Reference 85-95% 85% 80% 65% Hybrid Approach (Pd/Pa + FFR or Contrast FFR + FFR) Contrast FFR (Single Cutoff) Pd/Pa and ifr (Single Cutoff) Angiography Alone (QCA) * Prior to using hyperemic agents, please review the Instructions for Use for a complete listing of indications, contraindications, warnings, precautions, potential adverse events and directions. MATERIALS AND PRACTICALITIES TO MEASURE FFR: Proper anticoagulation (i.e. 50 U/kg unfractionated heparin) Intracoronary administration of nitrates (200 µg) Guiding catheters: any size can be used, but consider the following standard steps: Larger catheters: slightly disengage the guiding catheter from the ostium as they can impede the flow Smaller catheters (i.e. 5 F): adequately flush the guiding catheter with saline to remove residual contrast medium Not recommended: guiding catheters with side holes and diagnostic catheters PressureWire guidewire in combination with St. Jude Medical FFR platform (QUANTIEN Measurement System, OPTIS Mobile, OPTIS Integrated, RadiAnalyzer Xpress systems)
STANDARD STEPS TO MEASURE FFR: STEP 1: CALIBRATION STEP 2: EQUALIZATION STEP 3: MEASUREMENT STEP 4: VERIFICATION STEP 1: CALIBRATION Standard steps relating to zeroing the aortic transducer to atmospheric pressure 2,3 Position the transducer at the patient's heart level. Purge the aortic transducer system, zero the catheter tubing system and obtain an optimal aortic pressure waveform prior to FFR measurement. This prevents fluctuations in FFR measurement due to air bubbles shifting. When a contrast injector pump is used, ensure that the three-way stopcock and the aortic transducer are both positioned at the heart s level. Standard steps relating to zeroing the PressureWire guidewire to atmospheric pressure 2,3,5 Place package coil flat and then flush with 10 ml saline and wait 1 minute. Check pressure wire is correctly seated in the handle and the wire connector is tightened to ensure signal reliability. Press the connect button on the PressureWire receiver/quantien system/optis system. This must be done before the PressureWire guidewire is turned on. Slide the green slide on the PressureWire guidewire handle forward to turn on. During this step the PressureWire guidewire is zeroed upon connection. The PressureWire guidewire should stay in the package coil until Pd = 0. STEP 2: EQUALIZATION Standard steps relating to equalization of aortic pressure and PressureWire guidewire 1-3 The sensor of the PressureWire guidewire should be advanced a few millimeters beyond the tip of the guiding catheter. Remove introducer needle and close hemostatic valve. For aorto-ostial lesions, this should be performed with the disengaged catheter in the ascending aorta. Equalize the pressures registered by the guiding catheter and the pressure wire and observe for 1 minute. If the signal is not stable, re-equalize prior to FFR measurement. STEP 3: MEASUREMENT Standard steps relating to the advancement of PressureWire guidewire sensor distally 1-3 As per any intracoronary manipulation, proper anticoagulation and intracoronary nitrates (200 µg) should be administered prior to entering the coronary circulation. The sensor should be advanced to the distal two-thirds part of the coronary artery and at least 2 to 3 cm distal to the lesion (Figure 2). Ensure that the wire tip is rotating freely and no resistance is felt when torque is applied.
Figure 2. FFR Pressure Measurement ideal placement of PressureWire guidewire relative to the guide catheter Mean Aortic Pressure (RED) Mean Distal Pressure (GREEN) Pd/Pa ratio* (YELLOW) Mean Aortic Pressure Line (RED) Mean Distal Pressure Line (GREEN) *Pd/Pa = FFR only at maximum hyperemia If additional wire torque is required to position the PressureWire guidewire, loosen the wire connector on the PressureWire transmitter and remove transmitter. Do not turn off PressureWire guidewire to prevent repeat zeroing PressureWire guidewire to atmospheric pressure and Equalization steps. Dry proximal end of wire with dry gauze and re-connect transmitter prior to FFR measurement. Tighten wire connector to ensure signal reliability. Standard steps to induce hyperemia 2,6 When the sensor has been optimally positioned distal to the stenotic region, administer the hyperemic agent. Check that pressure measurement is stable and steady-state maximal hyperemia is achieved. Standard steps to measure FFR 3 Record the pressure tracing encompassing the baseline (10 beats), the beginning of the hyperemic phase and the recovery phase. The total recording duration will vary from the hyperemic agent used. Slightly reposition the PressureWire guidewire if spikes in the signal are seen due to the PressureWire guidewire sensor touching the vessel. Determine the lowest FFR value. STEP 4: VERIFICATION Standard steps to check for drift 3 Pull back PressureWire guidewire sensor to guiding catheter tip to verify equal pressures. If a drift larger than > 3 mmhg is seen, re-equalize and repeat the FFR measurement. Drift-related troubleshooting questions to ask: 2,5,7 Has the guiding catheter been adequately flushed with saline prior to equalization/prior to FFR measurement/and prior to checking for drift? Is the PressureWire guidewire checked at the same position as during equalization? Has the height of the aortic transducer been altered after equalization? Is the guiding catheter position in the coronary ostia different from equalization? Is the needle left in the Y-connector? Does the guide catheter have side-holes? Was the PressureWire guidewire prepared correctly (placed flat and flushed with 10 ml saline connected correctly)? Was the proximal end of the PressureWire guidewire cleaned before reseating into the transmitter/handle? The procedure settings during equalization and verification need to be exactly the same to rule out any drift.
PATIENTS AND VESSEL SELECTION FOR FFR INDICATIONS FOR FFR-BASED DECISION MAKING 8 Stable CAD NSTEMI/UA STEMI Clear culprit Yes No No Non-culprit Yes Yes Yes PHARMACOLOGIC AGENTS FOR INDUCING HYPEREMIA IN THE CATH LAB ADMINISTRATION AGENT DOSE EFFECT Intravenous (Preferably Central Venous) Adenosine 6 Agents for Inducing Coronary Hyperemia Dosage Table for IV Adenosine at 140 µg/kg/min Weight (lb) Weight (kg) Infusion (ml/hr) 99 45 378 110 50 420 121 55 462 132 60 504 143 65 546 154 70 588 165 75 630 176 80 672 187 85 714 198 90 756 209 95 798 220 100 840 231 105 882 243 110 924 254 115 966 265 120 1008 Infusion: 140 µg/kg/min ~ 1 min Duration: Infusion length Wear-off: ~ 1 min Intracoronary Adenosine 9 LCA: 200 µg RCA: 100 µg < 10 sec Duration: < 20 sec Intracoronary Papaverine 6 LCA: 16-20 mg RCA: 100 µg 10-30 sec Duration: 45-60 sec Intravenous (Central Venous or Peripheral) Regadenoson 10 Bolus: 400 µg Bolus ~ 30 sec Duration: Avg 2.5 min Wear-off: Potentially > 10 min
1. Sharif, F., Trana, C., Muller, O., & De Bruyne, B. (2010). Practical tips and tricks for the measurement of fractional flow reserve. Catheterization and Cardiovascular Interventions, 76(7), 978-985. 2. Vranckx, P., Cutlip, D. E., McFadden, E. P., Kern, M. J., Mehran, R., & Muller, O. (2012). Coronary pressure-derived fractional flow reserve measurements. Circulation: Cardiovascular Interventions, 5(2), 312-317. 3. Toth, G., Johnson, N. P., Jeremias, A., & De Bruyne, B. (2016). Standardization of FFR measurements. Journal of the American College of Cardiology, 68(7), 742-753. 4. Johnson, N. P., Jeremias, A., Zimmermann, F. M., Adjedj, J., Witt, N., Hennigan, B.,... Fearon, W. F. (2016). Continuum of vasodilator stress from rest to contrast medium to adenosine hyperemia for FFR assessment. Journal of the American College of Cardiology: Cardiovascular Interventions, 9(8): 757-767. 5. St Jude Medical Inc., 2016. PressureWire Aeris Instructions For Use. s.l.:s.n. 6. McGeoch, R. J., & Oldroyd, K. G. (2008). Pharmacological options for inducing maximal hyperemia during studies of coronary physiology. Catheter and Cardiovascular Interventions, 71, 198-204. 7. Svanerud, J. (2015). The future is here now, and its electrical. https://www.escardio.org/static_file/escardio/education/courses/resources%20from%20past%20courses/ Documents/301-J.%20Svanerudh.pdf. Accessed 28 May 2016. 8. Fearon, W. F., De Bruyne, B, & Pijls, N. H. (2016). Fractional flow reserve in acute coronary syndromes. Journal of the American College of Cardiology, 68(11), 1192-1194. 9. Adjedj, J., Toth, G. G., Johnson, N. P., Pellicano, M., Ferrara, A., Floré, V.,... Bruyne, B. D. (2015). TCT-293 Intracoronary Adenosine: Dose-Response Relationship with Hyperemia. Journal of the American College of Cardiology, 66(15). doi:10.1016/j.jacc.2015.08.308 10. van Nunen L. X., Lenders, G. D., Schampaert, S., van t Veer, M., Wijnbergen, I., Brueren, G. R.,... Pijls, N H. (2014). Single bolus intravenous regadenoson injection versus central venous infusion of adenosine for maximum coronary hyperemia in fractional flow reserve measurement. EuroIntervention, 2014 Aug 20. [Epub ahead of print] Rx Only Brief Summary: Prior to using these devices, please review the Instructions for Use for a complete listing of indications, contraindications, warnings, precautions, potential adverse events and directions for use. ifr is a trademark of Volcano Corporation. Unless otherwise noted, indicates that the name is a trademark of, or licensed to, St. Jude Medical or one of its subsidiaries. ST. JUDE MEDICAL and the nine-squares symbol are trademarks and service marks of St. Jude Medical, Inc. and its related companies. 2016 St. Jude Medical, Inc. All Rights Reserved. St. Jude Medical Inc. Global Headquarters One St. Jude Medical Drive St. Paul, MN 55117 USA T +1 651 756 2000 F +1 651 756 3301 St. Jude Medical S.C., Inc. Americas Division 6300 Bee Cave Road Bldg. Two, Suite 100 Austin, TX 78746 USA T +1 512 286 4000 F +1 512 732 2418 SJM Coordination Center BVBA The Corporate Village Da Vincilaan 11-Box F1 B-1935 Zaventem, Belgium T +32 2 774 68 11 F +32 2 772 83 84 St. Jude Medical Brasil Ltda. Rua Itapeva, 538 5º ao 8º andares 01332-000 São Paulo SP Brazil T +55 11 5080 5400 F +55 11 5080 5423 St. Jude Medical (Hong Kong) Ltd. Suite 1608, 16/F Exchange Tower 33 Wang Chiu Road Kowloon Bay, Kowloon Hong Kong SAR T +852 2996 7688 F +852 2956 0622 St. Jude Medical Japan Co., Ltd. Shiodome City Center 15F 1-5-2 Higashi Shinbashi, Minato-ku Tokyo 105-7115 Japan T +81 3 6255 6370 F +81 3 6255 6371 St. Jude Medical Australia Pty, Ltd. 17 Orion Road Lane Cove, NSW 2066 Australia T +61 2 9936 1200 F +61 2 9936 1222 SJM.com EM-FFR-0916-0015(1)a Item approved for U.S. use only.