Navvus FFR to reduce CONTRAst, Cost and radiaTion (CONTRACT); insights from a single-centre clinical and economical evaluation with the RXi Rapid-Exchange FFR device.
OBJECTIVE
To assess whether the RXi Navvus system compared to the use of standard Fractional Flow Reserve (FFR) wires reduces total contrast volume, radiation and overall study cost in a real world patient population referred for coronary angiography or percutaneous coronary intervention.


BACKGROUND
FFR is the mainstay of functional hemodynamic assessment of coronary artery lesions. The RXi Navvus system (ACIST Medical Systems, Eden Prairie, MN) is a monorail microcatheter with FFR-measurement capability through optical pressure sensor technology.


METHODS
This is an investigator-initiated, prospective, single-center, observational cohort study. A total of 238 patients were enrolled, 97 patients with Navvus and 141 with conventional pressure-wire based FFR (PW-FFR). Final analyses were performed on the cohort in which only 1 device was used (82 Navvus procedures vs. 136 PW-FFR procedures).


RESULTS
No significant differences were found in the total amount of contrast used (150±77 vs 147±79ml; p=0.81), radiation use (6200±4601 vs. 5076±4655 centiG∗cm2; p=0.09) or costs (€1994,- vs. €1930,-; p=0.32) in the Navvus vs. PW-FFR groups respectively.


CONCLUSIONS
No significant differences were found in the amount of contrast used, total procedural costs or radiation when the Navvus system was used as compared to conventional FFR wires.


CONCLUSIONS
CONTRACT is an investigator-initiated, prospective, single-center, observational cohort study that evaluated whether the RXi Navvus system compared to the use of standard Fractional Flow Reserve (FFR) wires reduces total contrast volume, radiation and overall study cost in a real world patient population referred for coronary angiography or percutaneous coronary intervention. Use of the RXi Navvus system was associated with comparable procedural costs, amount of radiation and contrast used as compared to PW-FFR systems.
Department of Cardiology, Thoraxcenter, Erasmus Medical Center, The Netherlands.
Kaneshka
K
Masdjedi
Department of Cardiology, Thoraxcenter, Erasmus Medical Center, The Netherlands.
Nicolas M
NM
Van Mieghem
Department of Cardiology, Thoraxcenter, Erasmus Medical Center, The Netherlands.
Roberto
R
Diletti
Department of Cardiology, Thoraxcenter, Erasmus Medical Center, The Netherlands.
Robert-Jan
RJ
van Geuns
Department of Cardiology, Thoraxcenter, Erasmus Medical Center, The Netherlands.
Peter
P
de Jaegere
Department of Cardiology, Thoraxcenter, Erasmus Medical Center, The Netherlands.
Evelyn
E
Regar
Department of Cardiology, Thoraxcenter, Erasmus Medical Center, The Netherlands.
Felix
F
Zijlstra
Department of Cardiology, Thoraxcenter, Erasmus Medical Center, The Netherlands.
Ron T
RT
van Domburg
Department of Cardiology, Thoraxcenter, Erasmus Medical Center, The Netherlands. Electronic address: j.daemen@erasmusmc.nl.
Joost
J
Daemen
D062906:Cardiac Catheters / Q000191:economics*; D017023:Coronary Angiography / Q000191:economics / Q000295:instrumentation*; D023921:Coronary Stenosis / Q000191:economics / Q000503:physiopathology / Q000601:surgery*; D003331:Coronary Vessels / Q000000981:diagnostic imaging / Q000503:physiopathology / Q000601:surgery*; D003362:Cost-Benefit Analysis; D004867:Equipment Design; D005260:Female; D005500:Follow-Up Studies; D053805:Fractional Flow Reserve, Myocardial; D006801:Humans; D008297:Male; D008875:Middle Aged; D008904:Miniaturization; D062645:Percutaneous Coronary Intervention / Q000191:economics / Q000295:instrumentation*; D011446:Prospective Studies
Cost-effectiveness; Fractional flow reserve; Navvus; PressureWire