Anand D Shah1, David S Hirsh1, Jonathan J Langberg2. 1. Division of Cardiology, Emory University School of Medicine, Atlanta, Georgia. 2. Division of Cardiology, Emory University School of Medicine, Atlanta, Georgia. Electronic address: jlangbe@emory.edu.
Abstract
BACKGROUND: Following increased rates of inside-out abrasion with the St Jude Medical Riata lead, the Durata implantable cardiac defibrillator (ICD) lead was introduced with modifications intended to increase abrasion resistance. Recent case reports have described insulation failures of the Durata. OBJECTIVE: To determine if increased rates of abrasion-related failure are present with the Durata lead. METHODS: The Food and Drug Administration Manufacturer and User Facility Device Experience database was queried for reports of insulation failure of the Durata lead from 2014. Comparison was made to other ICD leads. Incidence was estimated and case characteristics were compared. RESULTS: The estimated incidence of abrasion was significantly higher for the Durata lead than for the Boston Scientific Endotak or the Medtronic Quattro leads. The mode of abrasion was most often lead-to-can, as compared to "inside-out" abrasion with the Riata lead. Full-thickness abrasion was associated with failure to defibrillate or inappropriate therapy. Four patients had failure of therapy or death. CONCLUSIONS: The findings indicate higher rates of insulation failures of the Durata lead, despite design modifications. External abrasion from the pulse generator to the adjacent lead within the device pocket was the most common etiology. Shocks unmasked previously undetected abrasion, resulting in failure to defibrillate. Data are presented indicating a possible time dependency to abrasion risk. This limited query suggests need for ongoing scrutiny of Durata lead performance. Careful inspection of Durata leads at the time of ICD replacement is warranted, as are vigorous attempts to gather information about terminal events in patients with Durata leads.
BACKGROUND: Following increased rates of inside-out abrasion with the St Jude Medical Riata lead, the Durata implantable cardiac defibrillator (ICD) lead was introduced with modifications intended to increase abrasion resistance. Recent case reports have described insulation failures of the Durata. OBJECTIVE: To determine if increased rates of abrasion-related failure are present with the Durata lead. METHODS: The Food and Drug Administration Manufacturer and User Facility Device Experience database was queried for reports of insulation failure of the Durata lead from 2014. Comparison was made to other ICD leads. Incidence was estimated and case characteristics were compared. RESULTS: The estimated incidence of abrasion was significantly higher for the Durata lead than for the Boston Scientific Endotak or the Medtronic Quattro leads. The mode of abrasion was most often lead-to-can, as compared to "inside-out" abrasion with the Riata lead. Full-thickness abrasion was associated with failure to defibrillate or inappropriate therapy. Four patients had failure of therapy or death. CONCLUSIONS: The findings indicate higher rates of insulation failures of the Durata lead, despite design modifications. External abrasion from the pulse generator to the adjacent lead within the device pocket was the most common etiology. Shocks unmasked previously undetected abrasion, resulting in failure to defibrillate. Data are presented indicating a possible time dependency to abrasion risk. This limited query suggests need for ongoing scrutiny of Durata lead performance. Careful inspection of Durata leads at the time of ICD replacement is warranted, as are vigorous attempts to gather information about terminal events in patients with Durata leads.