HEARTWARE HVAD SYSTEM
Advanced Heart Failure Management
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HEARTWARE HVAD SYSTEM
Advanced Heart Failure Management
Learn from VAD Therapy experts as they discuss new data, trends, and implanting techniques in Mechanical Circulatory Support.
The world’s smallest centrifugal VAD now has the clinical evidence to prove its safety and effectiveness when used in a less-invasive thoracotomy approach.1,2
The latest clinical evidence from the HVAD LATERAL Trial2,3
HVAD LATERAL, the first trial to examine VAD implantation via thoracotomy, demonstrated that the HVAD System is safe and effective at 1-year follow-up, when implanted utilizing this technique. All primary and secondary endpoints were met.2
The primary endpoint was a composite of six-month survival free of disabling stroke (i.e., modified Rankin score ≥ 4 assessed 12 weeks post-event), while alive on the originally implanted device and free from disabling stroke, transplanted by month six or explanted due to left ventricular recovery by month six. Success is defined as non-inferiority of thoracotomy compared to sternotomy. Success was met if the lower bound of the one-sided exact 95% confidence limit was greater than 77.5%. LATERAL demonstrated 95% freedom from disabling stroke and 87% event-free survival rate at two years.2,3
The pre-specified secondary endpoint in LATERAL was an improvement in the mean length of initial hospital stay as compared to a performance goal of median sternotomy subjects: 18 ± 12 days for thoracotomy compared to 26 days for median sternotomy.
LATERAL also showed a 30% reduction in length of stay for enrolled patients implanted via thoracotomy compared to HVAD's previous BTT CAP trial, which only used the traditional sternotomy approach.2 The 14-day median length of stay for thoracotomy patients in LATERAL was 6 days shorter than in the BTT CAP trial (20).
Over 2,000 patients are enrolled in HeartWare HVAD trials.4
As many as 350 hospitals trust the HeartWare HVAD System. It's used in 56 countries and serves more than 18,000 patients worldwide.4
We continually learn and innovate, further advancing the management of end-stage heart failure. We are always striving to improve patient outcomes and the clinical experience of your practice.
The HeartWare™ HVAD™ Pump is engineered for reliability and durability.
The pump's passive maglev with hydrodynamic bearings means there's no need for electronic sensors or mechanical bearings. This results in a less complex system that eliminates friction, heat, and component wear.5
Dual motor stators enhance efficiency and provide redundancy to rotate the impeller.5
A patented, wide-blade impeller features three blood flow paths. These are designed to enhance blood flow and reduce blood trauma while reducing the time blood travels through the device.5
The unique integrated inflow cannula design offers the flexibility to fit into smaller framed patients and treat more complex patients.6-11 It also allows for stable inflow position even with body habitus changes.12
HVAD System Instructions for Use. HeartWare Inc. Framingham, MA USA 07/18. HeartMate 3 Left Ventricular Assist System, Instructions for Use. Thoratec Corporation, Pleasanton, CA, USA (02/17).
McGee E. Danter M, et al. Evaluation of a lateral throacotomy implant approach for a centrifugal-flow left ventricular assist device: The LATERAL clinical trial. JHLT. 2019;38(4):344-351.
Wieselthaler G. et al. Temporal Adverse Event Profile following LVAD Implantation via a Throacotomy Approach: 2 Year Follow-up of the LATERAL Trial. Presented at ASAIO 2019, San Francisco, CA.
Source data on file with Medtronic as of July 2019.
LaRose, J, et al. Design concepts and principal of operation of the HeartWare Ventricular Assist System. ASAIO J. 2010 Jul-Aug;56(4):285-9.
Abicht, T, et al. Complex HeartMate II infection treated with pump exchange to HeartWare HVAD, ASAIO J. 2013;59:188-192.
Gregoric, I, et al, Diaphragmatic implantation of the HeartWare Ventricular Assist Device. J Heart Lung Transpl. 2011;30: 467-70.
Takeda, K, et al. Successful implantation of HeartWare HVAD left ventricular assist device with concomitant ascending and sinus of valsalva aneurysms repair. J Artif Organs 2012;15:204-206.
Morshuis, M, et al. A modified technique for implantation of the HeartWareTM left ventricular assist device when using bivalirudin anticoagulation in patients with acute heparin-induced thrombocytopenia. Interactive CardioVascular and Thoracic Surgery (2013) 1-2 doi:10.1093/icvts/ivt187.
Palmen, M, et al. Implantation of a left ventricular assist device in patients with a complex apical anatomy. Ann Thorac Surg 2012;94: 2122-2125.
Sorensen EN, et al, Computed tomography correlates of inflow cannula malposition in a continuous-flow ventricular-assist-device. J Heart Lung Transpl 2013;32 (6):654-657.
Huang, J, et al. HeartWare ventricular assist device placement with congenitally corrected transposition of the great arteries. J Thorac and Cardiovasc Surg. 2013;145(2)e23-25.
Sabashnikov, a, et al. Outcomes in patients receiving Heartmate II versus HVAD left ventricular device as a bridge to transplantation. Transplant Proc. 2014;46:1469-75.