Following a finding by the US Food & Drug Administration, Medtronic is halting the global distribution of Medtronic’s HeartWare system following observational evidence associating its left ventricular assist device (LVAD) with increased neurological adverse events and mortality compared with similar mechanical circulatory support (MCS) devices, reports MedicalBrief.
Medtronic has urgently advises doctors to immediately stop new implants of the HeartWare HVAD Pump Implant device, but does not recommend prophylactic explant. Taking out recalled heart implants has to be carefully weighed against the potential risks of surgery. Doctors should decide “on a case-by-case basis, considering the patients clinical condition and surgical risks.” The company said it is preparing a guide for managing patients “who may require support for many years”.
Some HeartWare LVADs had already been recalled in December 2020 because of complaints that the pump may delay or fail to start. To date, there have been over 100 of these complaints, including reports of 14 patient deaths and 13 cases where an explant was necessary, the FDA said in a statement. The HVAD Pump Implant Kit will sometimes fail to start, causing a delay after the pump has been stopped. This can cause serious injuries or further complicate heart failure problems.
The decision affects approximately 2,000 US patients and 4,000 worldwide, including South Africa. The only other manufacturer of such devices is Abbott, which has stepped in to assist, in co-operation with Medtronic.
“We have been carefully monitoring the adverse events associated with this device and support its removal from the marketplace,” said Dr Bram Zuckerman, director of the Office of Cardiovascular Devices at the FDA's Center for Devices and Radiological Health.
“The FDA is working closely with both Medtronic and Abbott to ensure patient care is optimised during this transition period and that there is an adequate supply of devices available to provide this patient population with options for end-stage heart failure treatment.”
Abbott reassured the public in its own press release that it has the capacity and supply to support increased demand for MCS devices as a result of HeartWare's departure from clinical use.
The Heartware device was used for heart failure patients awaiting transplant or as a permanent implant for those who weren't healthy enough for that procedure.
Medtechdive writes that the move cedes the market to rival Abbott Laboratories and ends a product that has a troubled history from the start. Medtronic’s CEO Geoff Martha said Thursday (10 June 2021) during a virtual conference that a new analysis showing HeartWare HVAD had higher rates of stroke and mortality compared to Abbott's comparable device was a major influence in the decision.
“The Abbott device is better for patients,” the CEO said. “It's a challenging decision to make given the blood, sweat and tears we've invested in this therapy over the last six years, but this is clearly the right decision for patients.”
Mike Argentieri, vice president of technology and safety at ECRI, the independent safety and quality NGO, said physicians will require training on new devices and hospitals may need to build up an inventory of the new product.
“Step one, don't implant. But that's not trivial — and I don't want to minimise it — because what are your other choices?” Argentieri said. “Physicians are going to have to deal with the fact that they have to learn a whole new system in order to be able to do it. And this is a surgical implant, so there is technique involved.”
Argentieri added that physicians and hospitals will also have to manage patient anxieties for those who have a device already implanted.
ECRI sent an alert to approximately 1,000 hospitals to help ensure that the correct processes are followed. “We consider this alert to be critical,” Argentieri said. “This is a life support, life-sustaining product. It's implanted. It's a very invasive procedure. So, our major concern was to let people know about this as soon as possible.”
Full FDA statement (Open access)
Full Medtechdive report (Open access)
See also from the MedicalBrief archives:
LVADs should be a tool to assist patients with severe heart failure