Clinical Outcomes in Patients with a Novel Fully Magnetically Levitated Left Ventricular Assist Devices：A Multicenter Study

Introduction Heart failure (HF) represents a complex pathophysiological manifestation that emerges when cardiovascular diseases progress to their end stages, rendering the heart incapable of maintaining its function. The incidence of HF is continually rising globally, affecting over 60 million people worldwide, with approximately 6.4 million in the end-stage HF category. In China, it is conservatively estimated that there are about 13 million HF patients, including around 1 million in the end-stage. End-stage HF is characterized by persistent symptoms of HF that interfere with daily activities despite maximal medical therapy, leading to repeated hospitalizations. The annual mortality rate for patients at this stage is as high as 50%. Therefore, once end-stage HF occurs, it presents a prolonged and complex course, making treatment difficult and placing a significant burden on public health resources.

Currently, the main treatments for end-stage HF include heart transplantation (HTx) and mechanical circulatory support (MCS). HTx is considered the gold standard treatment for providing optimal survival and quality of life. However, the scarcity of donor hearts and the complexity of immunosuppressive therapy limit its application, with around 6,000 heart transplants performed globally each year, and only about 700 annually in China. MCS devices, such as left ventricular assist devices (LVADs), offer an effective alternative.

LVADs have undergone significant evolution through three generations of blood pumps, including pulsatile, axial flow, and centrifugal pumps (hydrodynamic levitation, magneto-hydrodynamic levitation, and fully magnetically levitated). They have become a critical treatment option for end-stage HF. In the United States, approximately 3,000 patients receive LVADs annually, surpassing the number of heart transplants. The U.S. Food and Drug Administration (FDA) has approved implantable LVADs for end-stage HF patients classified as INTERMACS levels 1 to 4, for use as long-term support (destination therapy, DT), as a bridge to transplant (BTT), and as a bridge to recovery (BTR). Over the past five years, LVAD therapy has undergone significant transformation and development internationally. The largest clinical trial to date on LVAD therapy has shown that compared to the HeartMate II, the latest generation centrifugal LVAD, the HeartMate III, significantly reduces the incidence of device thrombosis, stroke, gastrointestinal bleeding, and mortality. Compared to HTx, implantable LVADs have several advantages, such as the absence of the need for a donor heart and the lack of immune rejection, making them a life-saving device for an increasing number of end-stage HF patients.

The application of LVADs in China began relatively late but is currently experiencing rapid development. To date, there have been four officially approved LVADs in China. Among them, the CH-VAD (BrioHealth Solutions) is a novel centrifugal-flow device characterized by its fully magnetically levitated design and compact size. The first-in-man implantation of the CH-VAD took place in 2017 under compassionate use, marking a significant milestone in the application of durable LVADs in China. Following this, a multi-center, single arm clinical trial was conducted, providing data that led to the approval of this device in China in 2021. Thus far, more than 300 patients have been implanted with the technology across China. A single-center study conducted at Fuwai Hospital with 50 consecutive patients revealed promising outcomes and a favorable adverse event profile; however, the findings are limited by the single-center nature of the study and the relatively small sample size.

This multicenter observational study aims to evaluate the clinical efficacy and safety of the CH-VAD in end-stage HF patients when the device is used commercially, providing insights into its safety and effectiveness in real-world applications. This study includes all patients who received CH-VAD implants in a post-market approval setting between June 2022 and June 2024 across seven centers in China.