Modes of failure with fractional flow reserve guidewires: Insights from the manufacturer and user facility device experience database

ARTICLE HIGHLIGHTS

Research background

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.

Research motivation

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 shortcomings with one of the most common applied technology in the cardiac catheterization laboratory. With broadened global utilization of the FFR and newer iterations, standard reporting of adverse events and failure modes may improve patient selection, operator expertise and device technology.

Research objectives

The objective of our study was to investigate the most commonly reported adverse events and failure modes associated with commonly used FFR guidewires by analyzing the post-marketing surveillance data from the United States Food and Drug Administration Manufacturer and User Facility Device Experience (MAUDE) database.

Research methods

We queried the MAUDE database from January 2010 through April 2020 for 3 FFR guidewires [PressureWire^TM X (Abbott), Comet^TM (Boston Scientific), and Verrata^TM (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.

Research results

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.

Research conclusions

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.

Research perspectives

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 nonhyperemic pressure-based indices of stenosis severity such as instant wave-Free Ratio (iFR) and coregistered iFR pressure mapping may augur a paradigm shift for functional lesion assessment. It is pivotal for interventionalists to familiarize themselves with the common pitfalls associated not only with the standard FFR system but also with the newer iterations.