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Six-month outcomes in postapproval HeartMate3 patients: A single-center US experience
Aditya Bansal1,2, Faisal Akhtar1, Sapna Desai3
1Section of Cardiothoracic Surgery, Department of Surgery, Ochsner Clinic Foundation, New Orleans, Louisiana, USA.
Insights
Real-world use of the HeartMate 3 (HM3) left ventricular assist device (LVAD) shows comparable survival to clinical trials. Post-approval patients experienced fewer bleeding complications, indicating improved safety outcomes.
Area of Science:
- Cardiovascular Surgery
- Medical Devices
- Heart Failure Management
Background:
- The HeartMate 3 (HM3) left ventricular assist device (LVAD) has demonstrated safety and reduced hemocompatibility issues in prior studies.
- This study evaluates the real-world performance of the HM3 device following its FDA approval.
Purpose of the Study:
- To assess the real-world safety and efficacy of the HM3 LVAD in patients implanted after FDA approval.
- To compare outcomes between patients implanted during the HM3 trial and those implanted post-approval.
Main Methods:
- A retrospective, observational study of 174 patients implanted with the HM3 LVAD between October 2017 and March 2020.
- Patients were categorized into a trial group (n=82) and a post-approval group (n=92).
- Primary endpoint was 6-month survival; secondary endpoints included adverse events like pump thrombosis, stroke, and bleeding.
Main Results:
- Overall 6-month survival was comparable between the post-approval group (93.3%) and the trial group (93.8%).
- The post-approval group showed a significantly lower incidence of re-exploratory surgery for bleeding (10.9% vs. 46.3%, p=0.01).
- The post-approval group included younger patients with higher rates of bridge-to-transplant indications and INTERMACS profile 1.
Conclusions:
- Real-world 6-month survival with the HM3 LVAD post-approval is comparable to clinical trial findings.
- The HM3 device demonstrates improved safety in real-world use, particularly regarding reduced bleeding complications.
- Long-term outcomes require further investigation.
Background:
The European CE Mark approval study and the MOMENTUM 3 trial demonstrated safety and a reduction in hemocompatibility-related adverse events with the use of HeartMate 3 (HM3) device. This single-center study investigated the real-world experience in HM3 patients since FDA approval.
Methods:
This retrospective, observational study included patients implanted with the HM3 LVAD as a primary implant between October 2017 and March 2020. Patients were divided into trial group and postapproval group. The primary endpoint was survival at 6 months. Secondary endpoints were adverse events including pump thrombosis (requiring pump exchange), stroke, renal failure, acute limb ischemia, re-exploratory for bleeding, gastrointestinal bleeding, right ventricular failure, and driveline infection.
Results:
A total of 189 patients were implanted with HM3 device during the study period. 174 patients met the inclusion criteria: 82 patients in the trial group and 92 patients in the postapproval group. The postapproval group had younger patients, higher preoperative mean international normalized ratio, and greater numbers of patients with bridge to transplant (BTT) indications, IINTERMACS profile 1, and use of mechanical assist devices (other than IABP) than the trial group. Other characteristics between the two groups were comparable. Overall survival at 6 months in the postapproval group was 93.3% versus 93.8% (p = .88). The postapproval group demonstrated a statistically significant lower incidence of re-explorative surgery for bleeding (10.9% vs. 46.3, p = .01) than the trial group.
Conclusion:
In this single-center study, the real-world 6-month survival in the postapproval group was comparable to the trial results. Further studies are needed to monitor long-term outcomes.
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