TY - JOUR
T1 - The transseptal puncture experience
T2 - Safety insights from FDA MAUDE database
AU - Morcos, Ramez
AU - Megaly, Michael
AU - Desai, Anand
AU - Alkhouli, Mohamed
AU - Saad, Marwan
AU - Luna, Michael
AU - Garcia, Santiago
AU - Khalili, Houman
AU - Maini, Brijeshwar
N1 - Publisher Copyright:
© 2021 Wiley Periodicals LLC.
PY - 2021/11/15
Y1 - 2021/11/15
N2 - 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.
AB - 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.
KW - BRK
KW - MAUDE
KW - NRG
KW - transseptal needles
KW - transseptal puncture
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U2 - 10.1002/ccd.29746
DO - 10.1002/ccd.29746
M3 - Article
C2 - 33932271
AN - SCOPUS:85105390255
SN - 1522-1946
VL - 98
SP - E855-E861
JO - Catheterization and Cardiovascular Interventions
JF - Catheterization and Cardiovascular Interventions
IS - 6
ER -