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American Heart Association

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Final ID: Su2133

Complications Associated With the 4798 Attain Stability Active Fixation Coronary Sinus Lead: Insights from the MAUDE Registry

Abstract Body (Do not enter title and authors here): Background: The Attain Stability Quad 4798 [Medtronic, Minneapolis, MN] lead was recently developed with a mechanism for active fixation into the venous wall, allowing for precise and secure placement in coronary venous branches. However, real-world data regarding complication rates are limited.
Research Question: What are the real-world complications of the Medtronic 4798 lead?
Goals: We reviewed the United States Food and Drug Administration (FDA) Manufacturer and User Facility Device Experience (MAUDE) database for adverse events associated with the 4798 lead.
Methods: We reviewed the MAUDE database on November 15, 2023, for all reported complications due to the 4798 lead from January 1, 2018 – a year before the lead was approved by the FDA – to the present.
Results: A total of 2011 reports of adverse events occurred in mostly males (67.9%) patients with an average age of 70.86±12.1 years. Leads were used most frequently in 2023 (32.3%) for initial use (65.5%) but events commonly occurred intra-procedurally (73.7%). Device malfunction occurred in 43.4% of cases and included but was not limited to adverse events without an identified device problem (33.9%), device dislodgment (24.1%), infection (21.1%), and failure to capture (18.4%). In several cases, the guidewire was stuck (10.7%), or lead dislodgement (27.9%) occurred, resulting in direct helix damage (10.1%). Malfunctions resulted in injury and death in 55.8% and 1.1% of cases, respectively.
Conclusions: The use of an active fixation CS lead has been associated with a significant incidence of intraprocedural helix mechanism malfunction. Further real-world surveillance and registry data can help clarify the true incidence of lead failure.
  • Katapadi, Aashish  ( Kansas City Heart Rhythm Institute , Overland Park , Kansas , United States )
  • Lakkireddy, Dhanunjaya  ( Kansas City Heart Rhythm Institute , Overland Park , Kansas , United States )
  • Pothineni, Naga Venkata  ( Kansas City Heart Rhythm Institute , Overland Park , Kansas , United States )
  • Mansabdar, Aditya  ( Kansas City Heart Rhythm Institute , Overland Park , Kansas , United States )
  • Katapadi, Aashika  ( Xavier University School of Medicine , Oranjestad , Aruba )
  • Gangasani, Nikhil  ( Kansas City Heart Rhythm Institute , Overland Park , Kansas , United States )
  • Chelikam, Nikhila  ( Kansas City Heart Rhythm Institute , Overland Park , Kansas , United States )
  • Darden, Douglas  ( Kansas City Heart Rhythm Institute , Overland Park , Kansas , United States )
  • Gopinathannair, Rakesh  ( Kansas City Heart Rhythm Institute , Overland Park , Kansas , United States )
  • Kabra, Rajesh  ( Kansas City Heart Rhythm Institute , Overland Park , Kansas , United States )
  • Atkins, Donita  ( Kansas City Heart Rhythm Institute , Overland Park , Kansas , United States )
  • Author Disclosures:
    Aashish Katapadi: DO NOT have relevant financial relationships | Dhanunjaya Lakkireddy: DO NOT have relevant financial relationships | Naga Venkata Pothineni: No Answer | Aditya Mansabdar: DO NOT have relevant financial relationships | Aashika Katapadi: DO NOT have relevant financial relationships | Nikhil Gangasani: DO NOT have relevant financial relationships | Nikhila Chelikam: No Answer | Douglas Darden: DO NOT have relevant financial relationships | Rakesh Gopinathannair: DO NOT have relevant financial relationships | Rajesh Kabra: DO have relevant financial relationships ; Consultant:Volta Medical:Past (completed) | Donita Atkins: No Answer
Meeting Info:

Scientific Sessions 2024

2024

Chicago, Illinois

Session Info:

Improvements in Cardiac Implantable Electronic Device Therapies

Sunday, 11/17/2024 , 03:15PM - 04:15PM

Abstract Poster Session

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