The transseptal puncture experience: Safety insights from FDA MAUDE database
- 1 May 2021
- journal article
- research article
- Published by Wiley in Catheterization and Cardiovascular Interventions
- Vol. 98 (6), E855-E861
- https://doi.org/10.1002/ccd.29746
Abstract
Background There is a paucity of literature on safety and efficacy of various transseptal puncture (TSP) needles. Objectives To assess the reported mechanisms of failure, complications, and outcomes among the most frequently used transseptal needles in the United States. Methods We queried the Food and Drug Administration (FDA) Manufacturer and User Facility Device Experience (MAUDE) database between January 2011 and January 2021 for reports on the most commonly used transseptal needles: NRG (Baylis Medical, Montreal, Canada), and BRK (St. Jude, Saint Paul, MN)]. The primary outcome was the mechanism of failure. Secondary outcomes included clinical consequences of device failure. Results The final analysis included 306 reports of failure/complication with TSP needles (NRG n = 70, BRK n = 236). The most commonly reported mode of failure was detachment of the needle component (i.e., clip, hub, stopcock, shaft, spring, or needle tip) (14.7% overall; 17.8% BRK; and 4.3% NRG). Among these reports, cardiac perforation was the most common complication (69.9% overall; 69.1% for BRK; and 72.9% for NRG). Pericardiocentesis was the second most commonly reported complication (45.1% overall; 48.3% for BRK; and 34.3% for NRG). The procedure was successfully completed in 33.3% of all cases (36.4% for BRK and 22.9% for NRG), while surgical conversion was needed in (13.4% overall; 14% for BRK and 11.4% for NRG) of the reports. Death occurred in 3.9% of all cases overall (3.4% for BRK and 5.7% for NRG). Conclusions Needle detachment was the most common mode of failure, and cardiac perforation was the most common complication reported with TSP needles. Future efforts should focus on innovative TSP needle design, best practice guidelines, including role of imaging guidance, and increased TSP training.Keywords
This publication has 10 references indexed in Scilit:
- Complication prevention in ablation procedures: How to perform transseptal puncture safely in case of atrial septum aneurysmHeartRhythm Case Reports, 2019
- Comparison of a Radiofrequency Powered Flexible Needle with a Classic Rigid Brockenbrough Needle for Transseptal Punctures in Terms of Safety and EfficacyHeart, Lung and Circulation, 2015
- Randomized Trial of Conventional Transseptal Needle Versus Radiofrequency Energy Needle Puncture for Left Atrial Access (the TRAVERSE‐LA Study)Journal of the American Heart Association, 2013
- The use of a radiofrequency needle improves the safety and efficacy of transseptal puncture for atrial fibrillation ablationHeart Rhythm, 2011
- Prospective comparison between conventional transseptal puncture and transseptal needle puncture with radiofrequency energyJournal of Interventional Cardiac Electrophysiology, 2011
- Transcatheter creation of atrial septal perforation using a radiofrequency transseptal system: Novel approach as an alternative to transseptal needle punctureCatheterization and Cardiovascular Interventions, 2005
- Measuring inconsistency in meta-analysesBMJ, 2003
- Quantifying heterogeneity in a meta-analysisStatistics in Medicine, 2002
- Meta-analysis of Observational Studies in EpidemiologyA Proposal for ReportingJAMA, 2000
- Transseptal left atrial puncture: New technique for the measurement of left atrial pressure in manThe American Journal of Cardiology, 1959