CARDIOVASCULAR
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WHY USING PHYSIOLOGICAL INDICES IS ESSENTIAL

Angiographic assessment alone is not sufficient to diagnose the hemodynamic relevance of epicardial stenosis. Due to its innate limitations, angiography cannot be used to diagnose coronary microvascular dysfunction (CMD).1

This is why growing numbers of societies, thought leaders, and interventional cardiologists (ICs) recommend routine adoption of physiology measurements. The physiology assessment enables ICs to:

  • Go beyond the angiogram
  • Diagnose and treat only functionally significant epicardial lesions at stress or rest2,3
  • Diagnose microvascular disease in order to optimize patient management4

PressureWire™ X Guidewire is the only wireless physiology wire that can diagnose both epicardial and microvascular disease.5

Physiological Indices Defined

Objective Diagnosis of Epicardial and Microvascular Disease

View How PressureWire™ X Guidewire Measures FFR, RFR, IMR, and CFR

Video illustrating measurement of FFR, RFR, IMR, and CFR with PressureWire™ X Guidewire physiology wire
Video illustrating measurement of FFR, RFR, IMR, and CFR with PressureWire™ X Guidewire physiology wire

Diagnosing the Entire Coronary Vasculature

pci coroventis epicardial therapy ffr rfr imr cfr

Society Guidelines for Physiologic Indices

  Diagnosing Epicardial Stenosis Diagnosing Coronary Microvascular Dysfunction
  FFR RFR IMR CFR
Guidelines ACC/SCAI (view here)
CPT code (view here)
ESC Guideline 2019 (see table below)
Cutoff Value ≤ 0.86 ≤ 0.897 ≥ 254,* < 2.04,*
Formula Pd/Pa Lowest Pd/Pa ratio of whole-cycle Pd/Hyperemic Flow Hyperemic Flow/Baseline Flow
Hyperemia Yes No Yes Yes

*IMR and CFR cutoffs in population of ischemia with no obstructive coronary artery disease (INOCA) patients, CorMicA trial.4

hemodynamic system’s coronary flow reserve identifies CMD

a Class of recommendation. b Level of evidence.

Get the details about measuring each index, below.

Assessing whether Epicardial Stenosis needs intervention because there's more to CAD than an angiogram shows

Assessing Coronary Microvascular Dysfunction (CMD) because CMD may contribute to recurrent angina

PressureWire™ X Guidewire: Only Wireless Solution To Assess All Physiological Indices

With its pressure and temperature sensors, PressureWire™ X Guidewire has the capability to measure the entirety of the coronary circulation:5

  • The pressure can assess coronary data for FFR, Pd/Pa, and RFR measurements
  • The temperature can assess IMR and CFR measurements using thermodilution

PressureWire™ X Guidewire has been extensively studied and clinically validated in both stable and acute coronary syndrome (ACS) patients.9-11

PressureWire™: Nearly 20 Years of Evidence4,8,9,12-32

Timeline with trial results validating use of FFR, RFR, IMR, and CFR, along with Abbott's leadership role in developing some of the key studies

References

  1. Taqueti VR, Di Carli MF. Coronary microvascular disease pathogenic mechanisms and therapeutic options: JACC state-of-the-art review. J Am Coll Cardiol. 2018;72:2625-2641. doi:10.1016/j.jacc.2018.09.042.
  2. Pijls NH, de Bruyne B, Peels K, et al. Measurement of fractional flow reserve to assess the functional severity of coronary-artery stenoses. N Engl J Med. 1996;334(26):1703-1708.
  3. Xaplanteris P, Fournier S, Pijls NHJ, et al. Five-year outcomes with PCI guided by fractional flow reserve. N Engl J Med. 2018; 379:250-259.
  4. Ford TJ, Stanley B, Sidik N, et al. 1-year outcomes of angina management guided by invasive coronary function testing (CorMicA). J Am Coll Cardiol Intv. 2020;13:33-45
  5. Data on file at Abbott. Coroventis(doublecross) CoroFlow(doublecross) Cardiovascular System IFU.
  6. Jeremias A, Kirtane AJ, Stone GW. A test in context: fractional flow reserve: accuracy, prognostic implications, and limitations. J Am Coll Cardiol. 2017;69(22):2748‐2758. doi:10.1016/j.jacc.2017.04.019.
  7. Kobayashi Y, Johnson NP, Zimmermann FM, et al. Agreement of the resting distal to aortic coronary pressure with the instantaneous wave-free ratio. J Am Coll Cardiol. 2017;70(17):2105‐2113. doi:10.1016/j.jacc.2017.08.049.
  8. Knuuti J, Wijns W, Saraste A, et al. 2019 ESC Guidelines for the diagnosis and management of chronic coronary syndromes: the Task Force for the diagnosis and management of chronic coronary syndromes of the European Society of Cardiology (ESC). Eur Heart J. 2020;41(3);407-477. doi: 10.1093/eurheartj/ehz425.
  9. Pijls NH, et al. Fractional flow reserve versus angiography for guiding percutaneous coronary intervention in patients with multivessel coronary artery disease: 2-year follow-up results of FAME study. J Am Coll Cardiol. 2010;56:177-184.
  10. Zimmermann FM, Ferrara A, Johnson NP, et al. 2015: Deferral vs. performance of percutaneous coronary intervention of functionally non-significant coronary stenosis: 15-year follow-up of the DEFER trial. Eur Heart J. 2015;36(45):3182-3188. doi:10.1093/eurheartj/ehv452.
  11. Smits PC, Abdel‑Wahab M, Neumann FJ, et al. Fractional flow reserve–guided multivessel angioplasty in myocardial infarction. N Engl J Med. 2017;376:1234-1244. doi: 10.1056/NEJMoa1701067.
  12. DEFER Bech GJW, De Bruyne B, Pijls NHJ, et al. Fractional flow reserve to determine the appropriateness of angioplasty in moderate coronary stenosis: a randomized trial. Circulation. 2001;103:2928-2934.
  13. FAME Tonino PA, De Bruyne B, Pijls NH, et al. Fractional flow reserve versus angiography for guiding percutaneous coronary intervention. N Engl J Med. 2009;360(3):213-224.
  14. 2010 ESC Wijns W, Kolh P, Danchin N, et al. Guidelines on myocardial revascularization: the Task Force on Myocardial Revascularization of the European Society of Cardiology (ESC) and the European Association for Cardio-Thoracic Surgery (EACTS). Eur Heart J. 2010;31(20):2501-2555.
  15. FAME 2 De Bruyne B, Pijls NHJ, Kalesan B, et al. Fractional flow reserve-guided PCI versus medical therapy in stable coronary disease. N Engl J Med. 2012;367:991-1001.
  16. RIPCORD Curzen N, Rana O, Nicholas Z, et al. Does routine pressure wire assessment influence management strategy at coronary angiography for diagnosis of chest pain: the RIPCORD study. Circ Cardiovasc Interv. 2014;7(2):248-255.
  17. R3F Van Belle E, Rioufol G, Pouillot C, et al. Outcome impact of coronary revascularization strategy reclassification with fractional flow reserve at time of diagnostic angiography: insights from a large French multicenter fractional flow reserve registry. Circulation. 2014;129(2):173-185.
  18. POST-IT Bravo Baptista S, Raposo L, Santos L, et al. Patterns of use and clinical utility of FFR in patients referred for coronary angiography: the POST-IT (POrtuguese Study on The Evaluation of FFR-guIded Treatment of coronary disease) prospective multicentre registry. EuroPCR 2014.
  19. FAME 3 Initiated Pijls NHJ, et al. A comparison of fractional flow reserve-guided percutaneous coronary intervention and coronary artery bypass graft surgery in patients with multivessel coronary artery disease (FAME 3). NCT02100722.
  20. FAMOUS-NSTEMI Layland J, Oldroyd KG, Curzen N, et al. Fractional flow reserve vs. angiography in guiding management to optimize outcomes in non-ST-segment elevation myocardial infarction: the British Heart Foundation FAMOUS–NSTEMI randomized trial. Eur Heart J. 2015;36(2):100-111.
  21. DANAMI-3—PRIMULTI Engstrøm T, Kelbæk H, Helqvist S, et al. Complete revascularisation versus treatment of the culprit lesion only in patients with ST-segment elevation myocardial infarction and multivessel disease (DANAMI-3—PRIMULTI): an open-label, randomised controlled trial. Lancet. 2015;386(9994):665-671.
  22. CONTRAST Nishi T, Johnson NP, De Bruyne B, et al. Influence of contrast media dose and osmolality on the diagnostic performance of contrast fractional flow reserve. Circ Cardiovasc Interv. 2017;10:e004985.
  23. PRIME-FFR Van Belle E, Baptista SB, Raposo L, et al. Impact of routine fractional flow reserve on management decision and 1-year clinical outcome of patients with acute coronary syndromes: PRIME-FFR (insights from the POST-IT [POrtuguese Study on The Evaluation of FFR-guIded Treatment of coronary disease] and R3F [French FFR Registry] Integrated MulticEnter registries - implementation of FFR [fractional flow reserve] in routine practice). Circ Cardiovasc Interv. 2017;10:e004296.
  24. FAME 2, 3-Year Data: Fearon WF, Nishi T, De Bruyne B, et al. Clinical outcomes and cost-effectiveness of fractional flow reserve–guided percutaneous coronary intervention in patients with stable coronary artery disease: three-year follow-up of the FAME 2 Trial. Circulation. 2018;137:480-487.
  25. Fame 2, 5-Year Data: Xaplanteris P, Fournier S, Pijls NHJ, et al. Five-year outcomes with PCI guided by fractional flow reserve. N Engl J Med. 2018; 379:250-259.
  26. FAME 3 2017-19: Zimmermann FM, De Bruyne B, Pijls NHJ, et al. A protocol update of the Fractional Flow Reserve versus Angiography for Multivessel Evaluation (FAME) 3 trial: A comparison of fractional flow reserve-guided percutaneous coronary intervention and coronary artery bypass graft surgery in patients with multivessel coronary artery disease. Am Heart J. 2019;214:156-157.
  27. GRAFFITI Toth GG, De Bruyne B, Kala P, et al. Graft patency after FFR-guided versus angiography-guided coronary artery bypass grafting: the GRAFFITI trial. EuroIntervention. 2019;15(11):e999-e1005.
  28. SAVE-IT Ramos R, Batista S, Raposo L, et al. Strategies for revascularization in patients undergoing heart valve surgery with concomitant coronary artery disease (SAVE-IT). NCT02173860.
  29. COMPARE ACUTE Smits PC, Abdel-Wahab M, Neumann FJ, et al, on behalf of the Compare-Acute Investigators. Fractional flow reserve–guided multivessel angioplasty in myocardial infarction. N Engl J Med. 2017;376:1234-1244.
  30. FLOWER MI Puymirat E, et al. FLOW Evaluation to guide Revascularization in multi-vessel ST-elevation Myocardial Infarction (FLOWER-MI). NCT02943954.
  31. FULL REVASC Bohm F, James S, Rück A, et al. Ffr-gUidance for compLete Non-cuLprit REVASCularization (FULL REVASC). NCT02862119.
  32. FFR Global Registry Schampaert E, Kumar G, Achenbach S, et al. A global registry of fractional flow reserve (FFR)-guided management during routine care: study design, baseline characteristics and outcomes of invasive management. Catheter Cardiovasc Interv. Published online ahead of print, March 14, 2020.

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