Copyright
©The Author(s) 2021. Published by Baishideng Publishing Group Inc. All rights reserved.
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:
http://creativecommons.org/Licenses/by-nc/4.0/ Corresponding author: Waleed Tallat Kayani, MD, Assistant Professor, Department of Interventional Cardiology, Baylor College of Medicine, 1 Baylor Plaza, Houston, TX 77030, United States.
waleed83@gmail.com
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
Processing time: 188 Days and 13.7 Hours
BACKGROUND
Fractional flow reserve (FFR) measurement is commonly used in the cardiac catheterization laboratory to assess the functional significance of coronary arterial plaques. Robust real-world data on complications and modes of failure of FFR guidewires are limited.
AIM
To characterize these outcomes by analyzing the post-marketing surveillance data from the United States Food and Drug Administration Manufacturer and User Facility Device Experience (MAUDE) database for commonly used FFR guidewires.
METHODS
The MAUDE database was queried 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”. This yielded 544 reports. After excluding incomplete reports, 486 reports were analyzed.
RESULTS
Guidewire tip fracture was the most commonly reported mode of failure, 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%). In total, 133 (27.4%) device failures resulted in patient adverse events. The most common adverse event was retained guidewire tip, 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.
CONCLUSION
FFR guidewire failures can occur because of various mechanisms and cause patient adverse events. The MAUDE database serves as an important platform for improved collaboration among clinicians, device manufacturers, and regulators to improve device performance and optimize patient outcomes. Our analysis provides mechanistic insights of FFR guidewire failure and associated adverse events but cannot verify causality or provide a comparison among different guidewires.
Core Tip: We analyzed post-marketing surveillance data from the Food and Drug Administration Manufacturer and User Facility Device Experience database to outline the most common adverse events and modes of failure encountered with Fractional Flow Reserve (FFR) coronary guidewires. Guidewire tip fracture was the most commonly reported mode of failure, in 35.8% of cases; retained guidewire tip was the most common patient complication (53.4% of cases). FFR is an important frontline measurement in the cardiac catheterization laboratory to assess intracoronary physiology. Our analysis demonstrates that in real-world practice, FFR guidewire failures can occur because of myriad mechanisms and result in patient complications.
