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Percutaneous lead dysfunction in the HeartMate II left ventricular assist device
Dimitri Kalavrouziotis1, Michael Z Tong1, Randall C Starling2
1Department of Thoracic and Cardiovascular Surgery, Cleveland Clinic, Ohio.
The Annals of Thoracic Surgery
|February 5, 2014
Summary
Percutaneous lead failures in HeartMate II left ventricular assist devices occurred in 9.2% of pumps, primarily in the external cable. Design improvements have significantly reduced lead failure rates over time.
Area of Science:
- Cardiology
- Biomedical Engineering
- Medical Device Technology
Background:
- Percutaneous lead failure is a concern for patients with HeartMate II left ventricular assist devices.
- The exact incidence and impact of these lead failures were previously unknown.
Purpose of the Study:
- To determine the incidence of percutaneous lead failure in HeartMate II devices.
- To analyze the location, severity, and clinical outcomes associated with driveline failures.
- To evaluate the impact of design modifications on lead durability.
Main Methods:
- Retrospective review of all HeartMate II driveline dysfunctions reported to Thoratec Corporation.
- Analysis of lead failure location, severity, and association with adverse clinical events.
- Evaluation of the effect of lead design revisions on failure incidence.
Main Results:
- 9.2% of 12,969 implanted HeartMate II pumps experienced lead dysfunction over 13,932 patient-years.
- Most failures (87.2%) occurred in the externalized portion of the lead, suggesting fatigue.
- Lead failures leading to major adverse clinical events decreased significantly with design revisions (6.2% vs. 2.2% at 18 months).
Conclusions:
- Lead failures remain a critical factor affecting the long-term durability of left ventricular assist devices.
- Externalized driveline lead fatigue is a primary cause of failure in the HeartMate II.
- Improvements in lead design since 2004 have successfully reduced the incidence of lead failures.
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