"Death. Literally all you can think about is death." It's what you might expect to hear from a patient before they were able to receive an implanted heart pump. But it's the after for an unfortunate group of patients who talked to ProPublica about their HeartWare Ventricular Assist Device, or HVAD. As Neil Bedi and Maryam Jameel write, the device was discontinued this summer, with both the FDA and maker Medtronic agreeing that was the right move. The HVAD has "a history of unexplained malfunctions" and a study confirmed it has a higher rate of deaths and strokes than the only other left ventricular assist device that was available on the market, a version made by Abbott Laboratories. The problem is that the roughly 2,000 Americans who have the HVAD in their bodies can't just get it swapped for Abbott's version.
The surgery that would need to occur is thought to be riskier than leaving it in. But as Bedi and Jameel write, "They are now stuck in a medical dilemma that could have been prevented." Prevented, because the FDA was aware of manufacturing problems in 2014 and branded the device "adulterated." But its use continued for another seven years, with the FDA and Medtronic saying the benefits outweighed the risks. In the piece, Bedi and Jameel talk with a number of people who still have the HVAD—and the stress, fear, and anger they have along with it. Some say they only found out the device had been pulled from the market via social media or the news; others say they've incurred unexpected bills because they've had to undergo a pump exchange surgery when the part stopped working. Medtronic expanded the financial support it offered, but ProPublica found few patients were aware of that. (Read the full piece.)