March 06, 2025
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Key takeaways:There is only one mechanical heart pump available in the U.S. for patients with heart failure requiring left ventricular assistance. If the INNOVATE trial is successful, a second option could emerge. Left ventricular assist devices, which are mechanical heart pumps, are an important treatment for patients with advanced heart failure.LVADs assist weakened left ventricles to enable the heart to pump blood properly, and can be used as permanent solutions to the heart failure condition or used to stabilize a patient’s heart failure condition as a bridge to transplantation. LVADs are complex mechanical machines, and older past designs had problems with reliability and performance. In 2021, Medtronic halted the sale and distribution of its LVAD (HeartWare HVAD) due to the frequency of neurological adverse events and mortality compared with other devices, and prior to that, had issued a separate recall based on complaints that the internal pump may delay or fail to restart. That left only one LVAD on the U.S. market, the HeartMate 3 (Abbott), which has itself been subject to recalls that have required design modifications to address certain problems.
Sensing a need for a second LVAD option, researchers have begun the INNOVATE clinical trial comparing a new LVAD, the BrioVAD (BrioHealth Solutions), to the HeartMate 3. The primary outcome of the study will assess patient survival on the LVAD free of debilitating stroke or recovery of native heart function or receipt of a heart transplant up to 24 months following LVAD implant. Healio spoke with Francis D. Pagani, MD, PhD, national lead investigator for the INNOVATE trial and cardiac surgeon at the University of Michigan Health Frankel Cardiovascular Center, about why a new device is needed, why LVADs are so challenging, how the new device works and how patients with advanced HF might benefit if the trial is successful. Healio: Why is there a need for a new LVAD for patients with heart failure? Pagani: No. 1, the current technology we are using now has been in clinical use for 10 years. There’s a need to improve upon existing technology. No. 2, this is complex technology, and having only one pump available in the United States, if something should happen to this device, whether it’s a recall or supply-chain issues that make building the device problematic, there is no other option. For complex devices like this, there should always be more than just one option, for the safety of patients and to promote more technology development in the field. Healio: The HeartMate devices have had issues leading to recall and the HeartWare devices ended up being pulled from the market. Why have LVADs been so challenging in this way? Pagani: They are challenging. Think about what we are asking the device to do. We are trying to build a pump that replicates the function of the heart, to last an indefinite period of time. A lot needs to go into that design and development. We are asking a pump to function as the heart, and to be as reliable as the heart, and to not have any of the issues a normal heart would have. To replicate that kind of biological function is very complex. The devices we have now are exceedingly good. They do a fantastic job of achieving some of those excellent outcomes we are seeing. But there is still lots of room for improvement. Healio: How does the BrioVAD work compared with other mechanical heart pumps? Pagani: The BrioVAD has similar technology to the HeartMate 3. There are a few features on the BrioVAD that I think make it a very interesting pump. One is that it’s smaller in size. That is potentially very good, because it means the device might be available for patients with small body size or, in the future, it could potentially be tested in children, which is not possible for larger devices. Also important is that the percutaneously implanted driveline, which connects the pump to the outside world and the power supply, is much smaller and more flexible, and we think there may be benefit for patients in terms of reducing risk for infection and making it more comfortable for the patient. Healio: What is the heart failure community hoping to learn from this trial? Pagani: There are a number of things. Foremost is that we want to test the reliability and safety of the BrioVAD compared with HeartMate 3, which has established an excellent benchmark and achieved the best outcomes in the field over the past 30 years. So we are hoping that the BrioVAD meets or exceeds those benchmarks in terms of patient outcomes. We are also focusing on learning more about patient management. Are there things that we could do as physicians in the care of these patients to improve their outcomes? So we are testing the device itself and also trying to find ways to improve care for these patients. Healio: What are the implications if this trial is successful? Pagani: I think it will spur competition. If one company has a good device, another company will want to make a better device. I think it would create a competition that ultimately brings newer technology to the market, which is very good for the field, and everybody benefits by that. Hopefully, it will spur more interest in developing these types of heart pumps. As mentioned earlier, development of these devices is very challenging. There needs to be a lot of people involved from all different fields to develop these devices. Healio: Is there anything else you would like to mention? Pagani: The most important thing is that we need to increase choices for patients and physicians. To secure a safer environment for patients, we need different types of pumps in the field, and that is what we are working toward. References:
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Source:
Healio Interviews
Disclosures:
Pagani reports that the University of Michigan does contract research with BrioHealth Solutions as part of being a center involved in the trial, but he receives no personal financial compensation.
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