Retrospective Study
Copyright ©The Author(s) 2021. Published by Baishideng Publishing Group Inc. All rights reserved.
World J Cardiol. Jul 26, 2021; 13(7): 223-229
Published online Jul 26, 2021. doi: 10.4330/wjc.v13.i7.223
Modes of failure with fractional flow reserve guidewires: Insights from the manufacturer and user facility device experience database
Nauman Khalid, Yagya Pandey, Umair Khalid, Hassan Kamran, Jason P Wermers, Lovely Chhabra, Mahboob Alam, Hani Jneid, Waleed Tallat Kayani
Nauman Khalid, Department of Interventional Cardiology, St. Francis Medical Center, Monroe, LA 71201, United States
Yagya Pandey, Department of Internal Medicine, Baylor College of Medicine, Houston, TX 77030, United States
Umair Khalid, Hani Jneid, Department of Interventional Cardiology, Michael E. DeBakey VA Medical Center, Houston, TX 77030, United States
Hassan Kamran, Mahboob Alam, Waleed Tallat Kayani, Department of Interventional Cardiology, Baylor College of Medicine, Houston, TX 77030, United States
Jason P Wermers, Health Sciences, University of Maryland Graduate School, Baltimore, MD 21201, United States
Lovely Chhabra, Department of Cardiology, Westchester Medical Center Network Advanced Physician Services, New York, NY 12601, United States
Author contributions: Khalid N, Panday Y, and Kayani WT designed and performed the research and wrote the paper; Khalid U, Kamran H, and Wermers JP contributed to the analysis; Chhabra L and Alam M provided clinical advice; Jneid H and Kayani WT supervised the report.
Institutional review board statement: This study was conducted from a publicly available database, therefore, an approval from the institutional review board was not required.
Informed consent statement: Patients were not required to give informed consent for the study because the analysis used anonymous clinical data that were obtained from a freely accessible database.
Conflict-of-interest statement: We have no financial relationships to disclose.
Data sharing statement: No additional data are available.
Open-Access: This article is an open-access article that was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution NonCommercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See:
Corresponding author: Waleed Tallat Kayani, MD, Assistant Professor, Department of Interventional Cardiology, Baylor College of Medicine, 1 Baylor Plaza, Houston, TX 77030, United States.
Received: January 17, 2021
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
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 [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.

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.