Emerging pressure wire technology Justin Davies MBBS Ph
Emerging pressure wire technology Justin Davies, MBBS, Ph. D Interventional Cardiologist Hammersmith Hospital, Imperial College London CRT , Washington, 2016
Disclosure Statement of Financial Interest Within the past 12 months, I or my spouse/partner have had a financial interest/arrangement or affiliation with the organization(s) listed below. Affiliation/Financial Relationship • Grant/Research Support Company • Volcano Corp. , Medtronic, Philips, Astra Zeneca, and Re. Cor • Consulting Fees/Honoraria • Volcano Corp. , Medtronic • Intellectual Property / Royalty Rights • Volcano Corp. / Imperial College
Coronary Pressure Measurements during PCI 1979 Pa 1992 Pd HYPEREMIA FFR = Pd /Pa = 56/80 = 0. 70 Gruentzig, Lancet 1979 Emanuelsson, CCD 1992
FFR was developed in early 1990’s Pijls et al. Circulation 1993 De Bruyne et al. JACC 1993
Development of sensor-tipped wires 70 s Catheter-based Doppler systems 1974 Hartley CJ et al. J Appl Physiol 1977 Cole JS et al. Circulation 80 s Coronary flow velocity reserve (CFR) 1985 Wilson RF et al. Circulation 1990 Mc Ginn AL et al. Circulation 90 s Doppler flow guide wire 1992 Doucette JW et al. Circulation Fractional Flow Reserve (FFR) 1995 Pijls NHJ, De Bruyne B, NEJM 2001 Combowire; Siebes, Circulation 2001 Thermodilution; De. Bruyne, Circulation 2002 Acknowledgement: Jan Piek, AMC pressure Doppler
Current and new pressure wire based technology Current Volcano-Philips St Jude Medical New-pressure wire Boston Scientific Opsens Philips Other techniques Acist – Navvus microcatheter Co-Registration Philips-Volcano
Engineering characteristic of pressure guidewires and the Acist Navvus microcatheter
Optical Sensor Technologies Boston Scientific Opsens
Comet™ Pressure Guidewire COMET is a workhorse-like FFR guidewire designed to be highly deliverable, stand up to multiple reconnections and be fast. 3. Balanced at transition 4. High torque sleeve § Optical sensor § 3 cm Asahi tip § Precision cut body for 1: 1 1. Asahi Tip 5. 1: 1 torque experience § Reliable free spinning 2. Optical Sensor connection § Free spinning handle for minimal resistance steering Manufacturer: Boston Scientific
POLARIS™ PCI Guidance System Easy § POLARIS 1. 0 Software 1 is an all new operating system § It is intuitive, EASY to use and has a 1 -click pullback start Accurate § Improved Trace. Assist™ feature provides more accurate measurements 2 Deliverable § The Opti. Cross™ catheter is a highly DELIVERABLE catheter, especially in complex lesions 1 Polaris 1. 0 software running on i. Lab System 3. 0 | 2 Versus i. Lab 2. 7, BSC data on file. Manufacturer: Boston Scientific
Boston Scientific COMET Wire Validation Study (COMET) • performance of Boston Scientific Pressure Wire versus St Jude Pressure Wire • performance of Boston Scientific Pressure Wire versus Boston Scientific Pressure Wire • performance of St Jude Pressure Wire versus St Jude Pressure Wire University Hospital Southampton NHS Foundation Trust. NCT 02578381
Optowire One - Opsens
Opsens Optowire for Fractional Flow Reserve - The O 2 Pilot Study (O 2) • Safely reach and cross a target lesion; • Disconnect / re-connect testing • Safely remove the Optowire from the coronary artery. • Performance against established pressure wires. Olivier F Bertrand Laval University, Montreal NCT 02144090
New Sensor Technologies Philips
Verrata PLUS pressure guide wire *NEW* Sensor • Modern Sensor Design for low drift performance Side Exit Connector Cable • Quickly disconnect & reliably reconnect • Side exit cable now enables smooth wire delivery even when connected
Next Generation Pressure Wire Conventional Pressure Wire • Hypotube-based design • Electrical leads run alongside solid guide wire core Next Generation Pressure Wire • • All new construction with large, solid core designed for torque transmission Not dependent on a hypotube Cutting edge digital sensor using Philips proprietary technology All new connector design
Microcatheter solution Acist - Navvus
Navvus microcatheter
Navvus microcatheter: Relations with between Navvus FFR and pressure wire FFR Madhav Menon et al. Eurointervention 2015: 11
Navvus microcatheter: Relations with between Navvus FFR and pressure wire FFR Madhav Menon et al. Eurointervention 2015: 11
Navvus microcatheter: Significant variability when compared to pressure wire Madhav Menon et al. Eurointervention 2015: 11
The presence of a second guidewire significantly reduces accuracy of FFR clinical decision making Hein J. Verberne et al. Am J Physiol Heart Circ Physiol 2007; 292: H 2349 -H 2355
The presence of a second guidewire significantly reduces accuracy of FFR clinical decision making “The presence of two guidewires, especially across a myocardial perfusion scintigraphyinduced nonsignificant lesion, is associated with overestimation of the hemodynamically assessed lesion severity and, therefore, is likely to have a major impact on clinical decision making. “ Hein J. Verberne et al. Am J Physiol Heart Circ Physiol 2007; 292: H 2349 -H 2355
Studies comparing Navvus microcatheter with traditional pressure wires Diagnostic, reproducibility and measurement differences between Navvus microcatheter and Pressure guide wire ACIST-FFR NCT 02577484 N=240 Acist Medical Systems Vs PERFORM NCT 02648230 N=75 St Jude Medical
Co-Registration
Coronary Hammersmith Hospital, Imperial College NHS Trust London, UK Physiological assessment of Cx
Summary • Lots of new technologies • A range of different solutions • Remains uncertain how they compare against established technology • Select with caution until clinical trial data is available • Choice depends on more than just the wire itself
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