Abbott to Stop Making Trifecta Surgical Aortic Valves

Abbott is no longer manufacturing the Trifecta valve used in aortic valve replacement surgery following reports of higher risks of early structural valve deterioration (SVD), according to an announcement today from the US Food and Drug Administration.

The risks of early SVD—within 5 years or less—with the Trifecta and Trifecta valve with glide technology (GT) were first communicated to healthcare providers in February 2023. Today, Abbott issued a letter to healthcare providers saying they are withdrawing the valves from the US market and removing remaining inventory from the field.

The first-generation Trifecta valve, which is a trileaflet, stented, pericardial valve designed for supra-annular placement, was approved in 2011 (and is no longer marketed in the US) while the next-generation Trifecta GT was approved in 2016.

The FDA said their recommendations to physicians and patients haven’t changed since they issued their initial warning in February.

The agency advises physicians to be aware of the potential risk of SVD and to follow Abbott’s instructions when it comes to managing patients who have already received the Trifecta valve. All patients should seek medical care if they develop new symptoms, such as shortness of breath or fatigue, while annual follow-up visits, starting the first year after surgery, are recommended. Physicians are advised to assess transvalvular gradients and aortic regurgitation grade annually with transthoracic echocardiography (TTE) while those with hemodynamically significant SVD should be considered, after meeting with the heart team, for a possible valve intervention.

The FDA said they are working with Abbott to further evaluate the risk of early SVD and will keep the public informed if there are any new recommendations.