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Published on: August 16, 2021
Intrapericardial Left Ventricular Assist Device for Advanced Heart Failure
Joseph G Rogers1, Francis D Pagani1, Antone J Tatooles1
1From Duke University School of Medicine, Durham, NC (J.G.R., C.A.M.); University of Michigan, Ann Arbor (F.D.P., K.D.A.); Advocate Christ Medical Center, Oak Lawn (A.J.T., G.B.), and University of Chicago Medicine (V.J.) and Northwestern Memorial Hospital (A.S.A.), Chicago - all in Illinois; University of Louisville, Louisville, KY (M.S.S., E.J.B.); MedStar Heart Institute, Washington, DC (S.W.B., S.S.N.); University of Texas Health Science Center (I.D.G.) and Texas Heart Institute (H.M., O.H.F.), Houston; and HeartWare, Framingham, MA (K.L.).
A new centrifugal-flow left ventricular assist device (LVAD) is as effective as older axial-flow models for advanced heart failure patients. This mechanical circulatory support shows comparable survival rates, offering a viable alternative for those ineligible for heart transplants.
Area of Science:
- Cardiology
- Biomedical Engineering
- Medical Devices
Background:
- Mechanical circulatory support using left ventricular assist devices (LVADs) is a key treatment for end-stage heart failure.
- Patients ineligible for heart transplantation often require advanced support options.
Purpose of the Study:
- To compare the efficacy and safety of a novel intrapericardial centrifugal-flow LVAD against a standard axial-flow LVAD.
- To evaluate the primary endpoint of survival free from disabling stroke or device failure at two years.
Main Methods:
- A multicenter randomized trial involving 446 patients with advanced heart failure.
- Patients were assigned in a 2:1 ratio to either the centrifugal-flow (study) device or the axial-flow (control) device.
- The study was powered to demonstrate noninferiority of the study device.
Main Results:
- The centrifugal-flow LVAD was found to be noninferior to the axial-flow LVAD (estimated success rates 55.4% vs. 59.1%).
- Device malfunction or failure requiring replacement was more common in the control group (16.2% vs. 8.8%).
- Strokes were more frequent in the study group (29.7% vs. 12.1%), while quality of life improved similarly in both groups.
Conclusions:
- The intrapericardial centrifugal-flow LVAD is a noninferior alternative to axial-flow LVADs for patients with advanced heart failure.
- This finding supports the use of newer LVAD designs in mechanical circulatory support.
- Further research may explore strategies to mitigate stroke risk with centrifugal-flow devices.
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