Providers

The Monthly Pulse – Providers (Feb. 2024)

The Monthly Pulse

Industry News

Former FDA employees share concerns about heart device safety data

The Story

In a recent news interview, two former FDA employees have shared concerns about Abbott’s HeartMate 3 left ventricular assist device (LVAD). The device has been approved by the FDA as a long- and short-term treatment for heart failure. Since August 2017, more than 4,500 safety incidents have been reported about the device, and the former FDA employees note that death reports are still occurring at the same rate.

What You Should Know

Thoratec, an Abbott subsidiary, has reviewed reports of the adverse events and claims that there was no issue with the HeartMate 3 or its use 90% of the time. The HeartMate 3 is the only device of its kind, and Abbott’s public affairs director has issued a statement asserting that the pump has set the standard for clinical outcomes associated with LVAD therapy as an important option for people with late-stage heart failure. Still, the former FDA employees are concerned that the agency may be overlooking signs of a problem and question why adverse events are occurring at such a high rate.

Donated Heart Valves Still Growing a Year After World's 1st Partial Heart Transplant

The Story

More than a year after the world’s first partial heart transplant, the baby who underwent the surgery is doing well. Owen Monroe was born with type A2 persistent truncus arteriosus and irreparable truncal valve dysfunction and received living tissue implants containing pulmonary and aortic valves. The tissue is expected to grow with the child, and surgeons report that the valves have indeed shown adaptive growth and excellent function.

What You Should Know

Currently, cadaver homografts are the standard protocol for children with irreparable heart valve dysfunction. Yet, every time the child outgrows the valve implant, they must receive an exchange until an adult-sized valve fits, since cadaver homografts cannot grow. This can lead to poorly formed heart valves with inadequate function, and compounding effects like poor growth and impaired development. Not only would this new procedure help to address these challenges, but it could also present an opportunity to use donor organs that might otherwise go wasted.

Balloon-expandable TAVR valves linked to superior 1-year outcomes

The Story

According to findings recently published in the American Journal of Cardiology, transcatheter aortic valve replacement (TAVR) with a balloon-expandable valve is associated with better clinical outcomes than using self-expanding valves. Researchers in South Korea tracked data from nearly 1,200 TAVR patients. Results showed that BEV TAVR was associated with lower all-cause mortality than SEV TAVR (9.7% versus 14.4%), as well as lower rates of pacemaker implantation (5.8% versus 14.2%).

What You Should Know

Until this point, there has been limited research comparing BEV and SEV. Most of the existing data had been based on older-generation valves, or was extrapolated from other research such as landmark trials comparing TAVR with surgical aortic valve replacement. While further research could help clinicians make the best decisions for their patients, this study presents interesting findings that may be useful in the meantime.