Earlier this month, a patient with advanced heart failure became the first person in Europe to receive a BrioVAD left ventricular assist device at UMC Utrecht. The new system is being evaluated in a European clinical study and may offer advantages over existing assist devices. For UMC Utrecht, this implantation marks another milestone in its long history of innovation in mechanical circulatory support.
For people with advanced heart failure, a left ventricular assist device (LVAD) can make the difference between having little energy and being able to participate in daily life again. An LVAD supports circulation when medication or other treatments are no longer sufficient. The device pumps blood from the left ventricle to the aorta, taking over an important part of the heart’s workload.
Earlier this month, a multidisciplinary team at UMC Utrecht performed the first BrioVAD implantation in Europe. The procedure took place as part of the European BRIOLIFE study, which will involve ten European centers. “This is the first time we will be able to follow this new LVAD within a European research setting. It will provide valuable insights into both the performance of the system and patients’ experiences,” say cardiothoracic surgeon Faiz Ramjankhan, principal investigator of the study at UMC Utrecht, and cardiologist Mariusz Szymanski, who is responsible for patient selection within the study.
For the patient, participating in the study was an important decision: “When I heard I was eligible for this device, it felt like the right choice almost immediately. Of course, it was somewhat daunting to be the first patient in Europe, but I received thorough information and had the opportunity to discuss it with many people. In the end, I knew this was the right decision. I am still at the beginning of my recovery, but I am incredibly happy that I decided to do this.”
The BrioVAD has been developed for patients with advanced left-sided heart failure. According to the researchers, the system differs from existing LVADs in several ways. The pump is smaller and lighter, which may make it suitable for a wider range of patients. The external components have also been redesigned to make the system easier to carry and use.
Another notable difference is the driveline: the cable that connects the pump inside the body to the controller and batteries outside the body. This cable is thinner and more flexible than those used in many existing systems. Researchers expect this to improve ease of use and potentially reduce the risk of infections.
The European BRIOLIFE study aims to provide more insight into the system’s performance and patients’ experiences over the longer term. Szymanski explains: “The BrioVAD has several characteristics that make it interesting to study, such as its compact design and flexible driveline. At the same time, we do not yet know exactly what these features mean for patients and their quality of life in everyday practice. That is precisely why this study is so important.” Ramjankhan adds: “The fact that UMC Utrecht is the first center in Europe to participate fits well with our many years of experience in ventricular assist device care and research.”
The implantation of this new LVAD builds on more than thirty years of experience with mechanical circulatory support at UMC Utrecht. In 1993, the first Dutch patient received an LVAD in Utrecht. This made UMC Utrecht one of the pioneers of mechanical circulatory support in the Netherlands.
Since then, the treatment has evolved tremendously. Whereas LVADs were originally used mainly as a bridge to heart transplantation, they are now also used as a long-term treatment for patients who are not eligible for a donor heart. Some patients have now lived with an LVAD for more than fifteen years. At the same time, the systems have become smaller, more reliable, and easier to use.
UMC Utrecht has also played a leading role in other areas of mechanical heart support. In 2021, it became the first hospital in the Netherlands to implant a fully implantable artificial heart, which completely takes over the function of the heart.
The Utrecht program is characterized by close multidisciplinary collaboration between cardiologists, cardiac surgeons, nurses, and researchers in the care of patients with LVADs. Today, there are four specialized centers in the Netherlands that implant LVADs, and UMC Utrecht is one of them.
Each year, approximately forty patients receive a ventricular assist device at UMC Utrecht. Of the roughly 400 people currently living with a ventricular assist device in the Netherlands, about half were treated at UMC Utrecht. This makes UMC Utrecht the largest LVAD center in the Netherlands.
With the first European implantation of the BrioVAD, UMC Utrecht takes another step forward in the development of LVAD therapy.
For physicians and researchers, the implantation marks the beginning of a new phase in which they gain experience with this new generation of LVAD.
For the patient, the coming months will focus primarily on recovery and rehabilitation. “I need to take things slowly and gradually rebuild my fitness. My biggest goal is to be able to play outside with my son again. I look forward to having the energy for my family, my hobbies, and the ordinary things in life.”
A left ventricular assist device (LVAD) is a mechanical pump that supports the heart’s pumping function when the heart can no longer pump enough blood through the body on its own. The device takes over part of the heart’s workload, supports circulation, and improves the delivery of oxygen-rich blood throughout the body.
An LVAD is intended for patients with advanced heart failure for whom medication or other treatments are no longer effective. It can be used as a bridge to heart transplantation or as long-term therapy.
Many patients are able to do more after receiving an LVAD than they could before implantation. How active a person can be varies from patient to patient and depends on their overall health and recovery after surgery.
An LVAD is often used as a bridge to heart transplantation but can also serve as a long-term treatment for patients who are not eligible for a donor heart. Lifespan varies between patients. Some individuals have now lived with a ventricular assist device for more than fifteen years.
The BrioVAD is a new LVAD. The pump is smaller and lighter than many existing systems. It also features a thinner and more flexible driveline. In addition, the wearable external components have been designed to be more user-friendly. Researchers are investigating within the BRIOLIFE study how these features contribute to improved performance and patient experience.
The BrioVAD is being evaluated in the European BRIOLIFE study. Researchers aim to gain more insight into the safety, reliability, and performance of the system, as well as how patients experience living with the device in everyday life.
The BrioVAD is already being used outside Europe. In the United States, more than one hundred patients have been treated with the system. An earlier version of the device has also been used in China for several years, where more than seven hundred patients have received a comparable system.
Through the European BRIOLIFE study, physicians and researchers are investigating how the system performs in European patients and how they experience living with the device in daily life.
The group photo above shows, from left to right: Paul van Kaam, Faiz Ramjankhan, Corien Weersink, Mostafa Mokhles, Mariusz Szymanski, Marlies van Doleweerd en Bregje van der Wouden
