Industry insiders urge oversight of artificial heart tech

Left ventricular assist devices, also known as partial artificial hearts, or LVADs, have emerged as a standard treatment for pumping blood from the left ventricle to the aorta and therefore helping the world's 60 million people with heart failure.

Chinese LVAD companies in the field held in-depth discussions with international counterparts in Vienna, Austria last week, during which they called for establishing clear, unified definitions of the technology worldwide to better promote technological development and clinical applications.

The United States used to lead the field using blood pumps that rely on a fully magnetically levitated bearing design, which allows the pump's impeller, the spinning part, to be suspended and held in place with magnetic forces. Pump durability is maximized while damage to patients' blood cells is minimized because there is no contact between surfaces within the pump.

In the past decade, Chinese medical institutions have emerged as key players, and China's BrioHealth Technologies became one of only two players in the world that received approval from the United States Food and Drug Administration to offer the implantation of fully magnetically levitated pumps under clinical trial.

Marvin Slepian, former chairman of the International Society for Mechanical Circulatory Support, or ISMCS, said Chinese players are making "dramatic advances" in the technology, and making contributions to the field through their products.

Nobuyuki Kurita, an associate professor of surgery at Baylor College of Medicine, said Chinese companies developing "shockingly fast" have sufficient funds to invest, which is good for the industry and patients.

The medical symposium in Vienna was part of the 31st annual meeting of the ISMCS and featured Chinese companies being invited to contribute. Participants had advocated for consensus on the definitions, performance evaluation and standards of bearing technologies in rotary blood pumps.

In recent years, multiple LVADs have entered clinical applications worldwide, featuring different technical approaches, inconsistent terminology, vague definitions of core concepts, and insufficient disclosure of their technical approaches.

The call for clarity followed claims that some players had intentionally said their less advanced products, including using hydrodynamic bearings, were fully maglev.

According to Slepian, the lack of clarity has hindered effective communication between industry experts, research and development personnel, and clinical doctors, and has affected the accurate understanding and evaluation of product performance.

"We should have consistency of definitions," said Slepian, "It's very important to be very transparent in defining what's going on inside the device."

He added that variations in LVADs and the lack of clear definitions have meant people could have ended up with the wrong pump, in the same way that someone paying for an electric vehicle would not want to receive a car with an internal combustion engine.

Chen Chen, founder of BrioHealth Technologies, echoed the need for standardized definitions to move in the right direction.

Slepian said he expects next year's annual meeting of the ISMCS to be held in China. "We're very excited to have a lot of the Chinese companies there," he said. "We need to have a symposium on these issues next year in a very positive way."

wanghuazhong@chinadailyusa.com