糖心传媒

糖心传媒 cardiac experts shed insight on the HeartMate 3 LVAD.

贵顿础鈥檚 left ventricular assist device (LVAD) this April raised questions about whether the device is safe to implant in patients. Cardiac experts from 糖心传媒 explain why the HeartMate 3 remains a lifesaver for many patients with end-stage heart failure.

For patients with end-stage heart failure who aren鈥檛 eligible for a heart transplant, an LVAD can help the heart鈥檚 main pumping chamber, the left ventricle, pump blood long-term. Meanwhile, for patients who are awaiting a transplant, an LVAD serves as a stopgap.

贵顿础鈥檚 recall of the HeartMate 3 points to an issue with the device: extrinsic outflow graft obstruction. Over time, biological material can build up between the pump and the outflow bend relief tube, obstructing the outflow of blood. This event not only triggers a 鈥渓ow-flow alarm鈥� alerting the patient that their pump is not working, but 鈥渋n worst cases,鈥� 贵顿础鈥檚 announcement states, it 鈥渃ould result in death.鈥�

Experience counts

Physicians from advanced specialty cardiac centers like the USC Cardiac and Vascular Institute, part of Keck Medicine, tend to have more experience with the HeartMate 3 than other physicians. These specialists have long known about the risk of extrinsic outflow graft obstruction. They know what to watch for and what to do if it occurs.

鈥淥utflow graft obstruction is a known procedural complication,鈥� says Raymond C. Lee, MD, a cardiac surgeon with the USC Cardiac and Vascular Institute.

鈥淭he external outflow graft obstruction is something that鈥檚 been known for many years,鈥� agrees transplant cardiologist Ajay S. Vaidya, MD.

As Vaidya explains, 鈥淥ur center has robust clinical pathways developed in case we encounter this. We鈥檙e very confident in being able to both diagnose and treat it. It can be fixed through revision surgery or by replacing the outflow graft.鈥�

USC Cardiac and Vascular Institute specialists also know that the risk of extrinsic outflow graft obstruction is extremely low, he says. 鈥淔ortunately, extrinsic outflow graft obstruction is very rare. It is estimated to occur at a rate of only 0.24% two years after LVAD implantation and at a rate of 2.06% five years after implantation.鈥�

In fact, physicians who likely benefit most from 贵顿础鈥檚 warning are those with less experience using the device. HeartMate 3 LVADs are still uncommon at non-specialty centers, and these physicians may not know about extrinsic outflow graft obstruction risk and how to handle it.

Indeed, Vaidya says, 鈥淔DA wanted to ensure that the physicians implanting this device are aware of the issue so that they can deal with it appropriately in surgery.鈥�

The gold standard

The HeartMate 3 is still in the market. 贵顿础鈥檚 recall does not remove it from clinical use. This is important because the HeartMate 3 is a critical treatment for heart-failure patients.

鈥淭his device is the gold standard for the field,鈥� Lee says. 鈥淚t is the only FDA-approved device we have on the market for a durable LVAD.鈥�

鈥淗eartMate 3 LVADs are the gold standard of care in durable mechanical support that allows patients with end-stage heart failure to go home and live a life with minimal or no symptoms, and to have a much greater survival rate than that of other patients with end-stage heart failure,鈥� Vaidya adds.

The USC Cardiac and Vascular Institute will continue using the HeartMate 3. 鈥淲e can still implant these devices, and they鈥檙e overall very safe and effective in this population,鈥� Vaidya says.

Both say the USC Cardiac and Vascular Institute has never experienced extrinsic outflow graft obstruction in its years of using the HeartMate 3. 鈥淲e have never encountered this as a center. We don鈥檛 anticipate encountering it very often, if at all,鈥� Vaidya says. 鈥淲e鈥檝e also talked to colleagues across the country, and they鈥檝e rarely seen this. It is not a major issue.鈥�

So far, the center鈥檚 patients have not questioned the safety of the device. 鈥淚 would tell a patient who is concerned that this is a very rare complication,鈥� Vaidya says. 鈥淚t would not be an issue we foresee impacting their quality of life or their outcome after an LVAD implant.鈥�

鈥湽蠖俅♀�檚 recall could scare some of the lay public, people who don鈥檛 know the details about the device,鈥� Lee says. 鈥淏ut for people who work in the field, it is not a novel concern.鈥�

鈥淚 think the HeartMate 3 is still a very good device, and it will get better over time,鈥� he concludes. 鈥淭his known but uncommon complication will not preclude us from using the device.鈥�

Topics

Jennifer Grebow

Jennifer Grebow is manager of editorial services at 糖心传媒.

Share