Clinical use of physiological lesion assessment using pressure guidewires: an expert consensus document of the Japanese

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EXPERT CONSENSUS DOCUMENT

Clinical use of physiological lesion assessment using pressure guidewires: an expert consensus document of the Japanese Association of Cardiovascular Intervention and Therapeutics Yoshiaki Kawase1   · Hitoshi Matsuo1 · Takashi Akasaka1 · Yasutsugu Shiono1 · Nobuhiro Tanaka1 · Tetsuya Amano1 · Ken Kozuma1 · Masato Nakamura1 · Hiroyoshi Yokoi1 · Yoshio Kobayashi1 · Yuji Ikari1 Received: 20 November 2018 / Accepted: 20 November 2018 © Japanese Association of Cardiovascular Intervention and Therapeutics 2018

Abstract In this document, the background, concept, and current evidence are briefly summarized. The focus is on the clinical application of physiological lesion assessment from a practical standpoint for facilities that do not have ample experience. Finally, the characteristics of new resting indexes are summarized. Keywords  Coronary circulation · Coronary artery disease · Fractional flow reserve · Instantaneous wave-free ratio

Introduction Fractional flow reserve (FFR) has become a gold standard index for the invasive assessment of physiological severity of coronary artery stenosis. Coronary angiography is the traditional imaging modality for visual evaluation of coronary lesion severity and guidance of percutaneous coronary interventions (PCI)s. However, coronary angiography is in reality a two-dimensional shadowgraph of the vessel lumen. It cannot depict the arterial vessel wall or plaque burden. Moreover, it cannot approximate the amount of myocardium subtended by the target vessel. Without a proper assessment of physiological lesion severity, PCIs might mitigate its preferable effects on patient outcome [1]. Considering the importance of discriminating the lesions most likely to derive clinical benefit from PCIs, the Japanese Central Social Insurance Medical Council has changed the requirement for the reimbursement of PCIs in April 2018. Following this change, the role of physiological lesion assessment in catheter laboratories is expected to increase considering the low penetration rate of the non-invasive physiological test in Japan. In addition, a new hyperemia-free index as an indication of PCIs, namely instantaneous wave-free period (iFR) has * Yoshiaki Kawase ykawase@heart‑center.or.jp 1



Gifu Heart Center, Gifu, Japan

recently been validated and its non-inferiority in the prediction of 1-year outcome of FFR with the results of Functional Lesion Assessment of Intermediate Stenosis to Guide Revascularization (DEFINE-FLAIR) and iFR Swedish angiography and angioplasty registry (SWEDEHEART) has been demonstrated [2, 3]. However, there are many catheter laboratories that do not have adequate experience with physiological lesion assessment using pressure guidewires. In addition, there are many differences in clinical situations between Japan and Western countries (available drugs, the timing of physiological lesion assessment, etc.). In this document we summarize not only the current evidence but also the practical use of physiological lesion assessment in Japan.

Concept of