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Published on: May 11, 2018
Is there a difference in bleeding after left ventricular assist device implant: centrifugal versus axial?
Ann C Gaffey1, Carol W Chen2, Jennifer J Chung2
1Division of Cardiovascular Surgery, Department of Surgery, Perelman School of Medicine, University of Pennsylvania, Silverstein 6, 3400 Spruce St, Philadelphia, PA, 19104, USA. Ann.gaffey@uphs.upenn.edu.
Insights
Continuous-flow left ventricular assist devices (CF-LVADs) are standard for heart failure. This study found no significant difference in bleeding complications between axial and centrifugal flow CF-LVADs, suggesting similar safety profiles.
Area of Science:
- Cardiology
- Biomedical Engineering
- Medical Devices
Background:
- Continuous-flow left ventricular assist devices (CF-LVADs) are standard for end-stage heart failure.
- Increasing device reliability sparks debate on VADs versus transplant.
- Bleeding complications remain a significant concern, with ongoing debate about differences between major CF-LVAD types.
Purpose of the Study:
- To investigate and compare the adverse bleeding event profiles between two major types of continuous-flow left ventricular assist devices (CF-LVADs).
- To test the hypothesis that there would be similar adverse bleeding event profiles between centrifugal and axial flow CF-LVADs.
Main Methods:
- Retrospective analysis of isolated CF-LVADs (HeartMateII and HeartWare) implanted between July 2010 and July 2015.
- Review of demographic, perioperative, and short- and long-term outcomes, focusing on bleeding events.
- Comparison of bleeding rates, transfusion requirements, and reoperation for bleeding between device groups.
Main Results:
- No significant differences in demographics or comorbidities between HeartMateII (HMII) and HeartWare (HVAD) groups.
- Low and similar incidence of gastrointestinal (GI) bleeding (3.9% HMII vs. 2.9% HVAD).
- No significant differences in postoperative return to operating room for bleeding (27 HMII vs. 6 HVAD), stroke, re-intubation, driveline infection, or GI bleeding rates.
Conclusions:
- This study found no statistically significant difference in the rate of bleeding complications between commercially available axial (HMII) and centrifugal (HVAD) flow CF-LVADs.
- The findings suggest comparable bleeding risk profiles for these two major CF-LVAD types.
- Further research may explore other potential differentiating factors between device types.
Background:
Continuous-flow left ventricular assist devices (CF-LVAD) have become the standard of care for patients with end stage heart failure. Device reliability has increased, bringing the potential for VAD, compared to transplant, into debate. However, complications continue to limit VADs as first line therapy. Bleeding is a major morbidity. A debate exists as to the difference in bleeding profile between the major centrifugal and axial flow devices. We hypothesized that there would be similar adverse bleeding event profiles between the 2 major CF-LVADs.
Methods:
We retrospectively investigated isolated CF LVADs performed at our institution between July 2010 and July 2015: HeartMateII (HMII, n = 105) and HeartWare (HVAD, n = 34). We reviewed demographic, perioperative and short- and long-term outcomes.
Results:
There was no significant difference in demographics or comorbidities. There was a low incidence of gastrointestinal (GI) bleed 3.9% in HMII and 2.9% in HVAD (p = 0.78). Preoperatively, the cohorts did not differ in coagulation measures (p = 0.95). Within the post-operative period, there was no difference in product transfusion: red blood cells (p = 0.10), fresh frozen plasma (p = 0.19), and platelets (p = 0.89). Post-operatively, a higher but not significantly different number of HMII patients returned to the operating room for bleeding (n = 27) compared to HVAD (n = 6, p = 0.35). There was no difference in rates of stroke (p = 0.65), re-intubation (p = 0.60), driveline infection (p = 0.05), and GI bleeding (p = 0.31). The patients had equivalent ICU LOS (p = 0.86) and index hospitalization LOS (p = 0.59).
Conclusion:
We found no difference in the rate of bleeding complications between the current commercially available axial and centrifugal flow devices.
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