Published online Jul 26, 2021. doi: 10.4330/wjc.v13.i7.223
Peer-review started: January 17, 2021
First decision: February 14, 2021
Revised: February 26, 2021
Accepted: July 5, 2021
Article in press: July 5, 2021
Published online: July 26, 2021
Fractional flow reserve (FFR) measurement is an essential tool in the cardiac catheterization laboratory to assess the functional significance of coronary artery lesions. Robust real-world data on the commonly reported complications and modes of failure associated with the FFR guidewires are scarce.
The landmark clinical trials that support routine physiologic lesion assessment with FFR did not specifically address adverse events associated with the use of FFR guidewires. Accordingly, this provided us the impetus to explore common short
The objective of our study was to investigate the most commonly reported adverse events and failure modes associated with commonly used FFR guidewires by analy
We queried the MAUDE database from January 2010 through April 2020 for 3 FFR guidewires [PressureWireTM X (Abbott), CometTM (Boston Scientific), and VerrataTM (Philips)] by searching for the following events: “Injury”, “malfunction”, “death”, and “other”. The search yielded 544 reports. After excluding incomplete and duplicate reports, 486 reports were included in the final analysis.
The most commonly reported mode of failure was guidewire tip fracture described in 174 (35.8%) cases followed by guidewire kinking (n = 152, 31.3%), communication failure (n = 141, 29.0%), and shaft fracture (n = 67, 13.8%). One hundred thirty-three (27.4%) device failures caused patient adverse events. The most commonly reported adverse event was retained guidewire tip described in 71 (53.4%) cases, followed by freshly deployed stent dislodgment (n = 26, 19.6%) and coronary artery dissection (n = 23, 17.3%). Seven deaths were reported.
FFR guidewire failures can occur because of myriad mechanisms and cause patient adverse events. Understanding the methods of FFR guidewire failure is critical for interventionalists to develop operational awareness, forebode challenging situations, evaluate common complications, and assuage adverse patient events. The MAUDE database serves as an important pulpit for improved collaboration among physicians, device manufacturers, and regulators to improve device performance and optimize patient outcomes.
Intermediate coronary lesions are commonly encountered during cardiac catheterization and present a diagnostic dilemma. Physiologic testing using a pressure wire-based system is appropriate for these lesions. The introduction of newer nonhy