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The Thoratec Implantable Ventricular Assist Device (IVAD): initial clinical experience
Louis E Samuels1, Elena C Holmes, Kevin Hagan
1Department of Cardiothoracic Surgery, The Lankenau Hospital, Wynnewood, PA 19096, USA. SamuelsLE@aol.com
The Heart Surgery Forum
|June 8, 2006
Summary
The Thoratec Implantable Ventricular Assist Device (IVAD) offers a viable solution for heart failure, enabling home discharge and serving as a bridge to transplant or recovery.
Area of Science:
- Cardiology
- Medical Devices
- Surgical Technology
Background:
- The Thoratec Implantable Ventricular Assist Device (IVAD) is the sole FDA-approved intracorporeal biventricular cardiac assist device.
- It represents an advancement over the Paracorporeal Ventricular Assist Device (PVAD), featuring a titanium coating.
- Compatibility with the portable TLC-II driver facilitates patient discharge to home care.
Purpose of the Study:
- To evaluate the safety and efficacy of the Thoratec Implantable Ventricular Assist Device (IVAD) in patients with severe heart failure.
- To assess the device's performance as a bridge to transplantation or recovery.
- To determine the feasibility of home discharge with the IVAD system.
Main Methods:
- Nine consecutive patients with acute or chronic heart failure received IVAD implantation between June 2005 and March 2006.
- All patients underwent maximal medical therapy, including intravenous inotropic drugs, prior to device implantation.
- Patient outcomes, including survival, device function, complications, and discharge status, were monitored.
Main Results:
- All nine patients survived the surgical implantation procedure.
- Six patients achieved successful outcomes: 3 received transplants after discharge, 2 awaited transplantation (1 at home, 1 in-house), and 1 was successfully explanted.
- Three patients experienced postoperative mortality due to multiple organ system failure (2) or pulmonary hemorrhage (1). No device malfunctions were reported. One driveline infection and one thromboembolic event occurred.
Conclusions:
- The IVAD demonstrates versatility in providing uni- or bi-ventricular support for acute and chronic heart failure.
- The device offers potential for bridging patients to transplantation or facilitating recovery.
- Home discharge is a feasible option for patients supported by the IVAD.
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