Active fixation coronary sinus (CS) leads provide additional support within the CS via deployable lobes or a side helix. However, adherence to the CS may lead to higher risk of extraction and CS tear during extraction. There is limited data on outcomes of CS tear during active fixation lead extraction.
To assess outcomes of cardiovascular injury events and CS tear during extraction of active fixation CS leads.
We searched the US Food and Drug Administration’s (FDA) Manufacturers and User Defined Experience (MAUDE) database from 8/15/2008 to 8/01/2020 for adverse events of injury or death involving the Attain StarFix lead and Attain Stability lead. Events were reviewed by 2 physicians to identify instances of cardiovascular injury during extraction.
There were 25 cases of cardiovascular injury events during extraction of active fixation CS leads and all involved the Starfix lead. In 96% of cases (24/25), there was CS tear. These patients developed hypotension, pericardial effusion, or cardiac tamponade after extraction of the StarFix lead. Overall, 84% of patients (21/24) required emergency sternotomy, while 12% of patients (3/24) were successfully treated with pericardial drainage alone. Among patients who required emergency sternotomy, CS tear was successfully repaired in 86% of patients (18/21). The remaining 14% of patients (3/21) died during the surgical rescue attempt. Among the patients whom the CS was successfully repaired, 83% of patients (15/18) survived till hospital discharge. In the remaining patients, one had consumptive coagulopathy and died 45 minutes after the rescue attempt, one died at post-op day 2, and one died at post-op day 11.
These findings suggest that CS tear during StarFx lead extraction often requires emergent sternotomy and repair of the CS tear. Skilled standby cardiothoracic surgery is essential when performing lead extraction of a Starfix lead. Extraction of this lead should only be attempted by highly qualified physicians in specialized centers.
© 2021 Published by Elsevier Inc.