Details

Autor(en) / Beteiligte

• Jaisingh, Keerthish C
• Jiwani, Sania
• Thotamgari, Sahith Reddy
• Ponna, Pramod Kumar
• Dominic, Paari

Titel

Abstract 14439: Complications With Medtronic’s SelectSecure 3830 Leads When Used for Atrial and Ventricular Pacing versus Conduction System Pacing in the United States

Ist Teil von

• Circulation (New York, N.Y.), 2021-11, Vol.144 (Suppl_1)

Erscheinungsjahr

2021

Quelle

Free E-Journal (出版社公開部分のみ）

Beschreibungen/Notizen

• Abstract only Introduction: Conduction system pacing is physiological and is therefore gaining interest. The Medtronic SelectSecure 3830 lead was officially approved by the FDA for His-bundle pacing (HBP) in 2018. However, prior to 2017-2018, this lead was mainly used for atrial pacing, ventricular pacing, or both. We evaluated and compared nationwide adverse events and complications associated with this lead prior to and after 2017. Hypothesis: Compare adverse events and complications associated with Medtronic’s SelectSecure 3830 leads before 2017 when it was mainly used for atrial, ventricular, or atrial and ventricular pacing to events after 2017 when it was mainly used for HBP. Methods: We collected adverse event reports from the FDA’s Manufacturer and User Facility Device Experience (MAUDE) on SelectSecure 3830 leads between 2008 and 2020. We searched the data base with key words “selectsecure” and “select secure” along with the model number “3830” to aggregate the data. Duplicate entries were screened and removed, and the location the leads were used was classified. Results: Total number of adverse events reported before 2017 was 393 (90.5%) when compared to after 2017, 41 (9.5%). The percentage of adverse events reported when the lead was used for atrial, ventricular, or atrial and ventricular pacing was 95.3%, when compared to 4.7% when the lead was used for HBP. The most common adverse events reported were capture and threshold issues (16.8%; PRR for atrial/ventricular lead location 0.76 [95% CI: 0.32-1.78] vs. 1.30 [95% CI: 0.55-3.06] for His-bundle lead location) and lead dislodgement (15.6%; PRR for atrial/ventricular lead location 1.03 [95% CI: 0.27-3.81] vs. 0.96 [95% CI: 0.26-3.58] for His-bundle lead location); which were comparable. Conclusion: Medtronic’s SelectSecure 3830 leads had comparable capture/threshold and lead dislodgement issues regardless of the atrial, ventricular, or His-bundle location.