Join our expert faculty as they discuss procedural economic outcomes and the hospital savings associated with the less invasive thoracotomy approach for implantation of LVADs compared to sternotomy implants.

Damian May, Director, Reimbursement Programs and Global EV Strategy, Minneapolis, Minnesota

Nahush Mokadam, M.D., Professor and Director, Cardiac Surgery, The Ohio State University, Wexner Medical Center

Scott Silvestry, M.D., Surgical Director, Thoracic Transplant Programs, Transplant Institute, AdventHealth

Cardiac Surgeons, Heart Failure Program Administrators, Heart Failure Cardiologists

Complete the form below to register for the upcoming Global Grand Rounds program. You will receive a confirmation email with detailed login information to use on the day of the program and will be emailed reminders prior to the start of the event.

Brief Statement

HeartWare™ HVAD™ System

Indications For Use: The HeartWare™ HVAD™ System is indicated for hemodynamic

support in patients with advanced, refractory left ventricular heart failure; either as a

Bridge to Cardiac Transplantation (BTT), myocardial recovery, or as Destination Therapy

(DT) in patients for whom subsequent transplantation is not planned.

Contraindications: The HeartWare System is contraindicated in patients who cannot

tolerate anticoagulation therapy.

Warnings/Precautions: Proper usage and maintenance of the HVAD™ System is critical

for the functioning of the device. Serious and life-threatening adverse events, including

stroke have been associated with use of this device. Blood pressure management may

reduce the risk of stroke. Never disconnect from two power sources at the same time

(batteries or power adapters) since this will stop the pump, which could lead to serious

injury or death. At least one power source must be connected at all times. Always keep

a spare controller and fully charged spare batteries available at all times in case of an

emergency. Do not disconnect the driveline from the controller or the pump will stop.

Avoid devices and conditions that may induce strong static discharges as this may cause

the VAD to perform improperly or stop. Magnetic resonance imaging (MRI) could

cause harm to the patient or could cause the pump to stop. The HVAD™ Pump may

cause interference with automatic implantable cardioverter-defibrillators (AICDs), which

may lead to inappropriate shocks, arrhythmia, and death. Chest compressions may

pose a risk due to pump location and position of the outflow graft on the aorta — use

clinical judgment. If chest compressions have been administered, confirm function and

positioning of HVAD Pump post-CPR.

Potential Complications: Implantation of a VAD is an invasive procedure requiring

general anesthesia and entry into the thoracic cavity. There are numerous known risks

associated with this surgical procedure and the therapy including, but not limited to,

death, stroke, neurological dysfunction, device malfunction, peripheral and device related

thromboembolic events, bleeding, right ventricular failure, infection, hemolysis,

and sepsis. Refer to the “Instructions for Use” for detailed information regarding the

implant procedure, indications, contraindications, warnings, precautions, and potential

adverse events prior to using this device.

Caution: Federal law (USA) restricts these devices to sale by or on the order of a

physician.

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