Federal health officials have issued a warning about certain heart valve replacement devices made by Abbott. These devices, called the Trifecta Valve and the Trifecta Valve with Glide Technology, may deteriorate much faster than other similar devices. This could lead to patients needing another surgery to replace the valve sooner than expected or even experiencing serious and life-threatening health problems.
The Trifecta and Trifecta GT valves are used to treat people with heart valve problems, specifically with the aortic heart valve, which is an important valve that helps the heart function properly. The valves are intended as a replacement for a diseased, damaged, or malfunctioning native or prosthetic aortic heart valve.
The FDA approved the first-generation Trifecta valve in 2011, but it is no longer sold – with good reason – in the United States. The Trifecta GT valve, which was approved in 2016, is currently the only Abbott heart valve replacement device still available in the United States. It was approved with the hope that this new tissue valve would offer enhancements that would make the implantation process smoother, providing a solution to patients, even those with more challenging cases.
This warming chill some of those hopes. There have also been concerns about the detachment of the device’s noncoronary cusp, which lead to aortic regurgitation in the now-discontinued first generation of Trifecta valves
Trifecta Valve with Glide Technology
The Abbott Trifecta valve is a type of mechanical heart valve used in cardiac surgery to replace a diseased or damaged heart valve. It is designed to mimic the function of a natural heart valve and is made from materials that are durable and biocompatible. It initially showed short-term durability.
Some key features of the Abbott Trifecta valve include:
- The valve is made from a bovine pericardial tissue (the membrane that surrounds the heart of a cow), which is treated to make it durable and resistant to calcification (a process that can lead to the valve becoming stiff and less effective)
- The valve has a unique design that is intended to improve blood flow and reduce turbulence, which can help to reduce the risk of blood clots and other complications
- The valve is available in a range of sizes, allowing surgeons the flexibility to choose the best fit for each patient
- The valve is designed to be implanted using a minimally invasive surgical approach, which can help to reduce recovery time and improve patient outcomes
Another huge advantage of the Abbott Trifecta valve over other types of mechanical heart valves is that it is less likely to cause blood clots, which can lead to serious complications such as stroke or heart attack. However, like all mechanical heart valves, the Abbott Trifecta valve requires lifelong anticoagulation therapy (blood-thinning medication) to prevent clotting.
No Trifecta Recall
The FDA has received reports of early structural valve deterioration (SVD) among Abbott Trifecta heart valve replacement devices, especially within three to four years of implantation. This has resulted in some patients requiring surgical explantation and transcatheter valve-in-valve interventions, and unfortunately, some patients have died as a result.
Still, there is no Trifecta recall at this point, just this concern from the FDA. The FDA announced that it will collaborate with Abbott to conduct a more in-depth investigation into the underlying causes of early SVD and create additional patient management approaches if deemed necessary and Abbott has expressed is a willingness to do whatever it takes to get to the bottom of it.
What Is Abbott Saying Doctors and Patients Should Do?
Abbott is saying that:
- Patients should be “extra aware” (I’m paraphrasing) of symptoms such as shortness of breath or fatigue and seek medical attention if they occur.
- A transthoracic echocardiogram (TTE) study should be conducted within 1 to 3 months after the procedure to assess valve hemodynamics and ventricular function.
- Annual follow-up visits, including TTE assessments, should be scheduled starting one year after the implant.
- If patients experience symptoms or signs of potential SVD, they should get a transthoracic echocardiogram.
- If SVD is present, a heart team should consider surgical aortic valve replacement (SAVR) or transcatheter valve-in-valve intervention depending on the patient’s individual risks and benefits.
- Before a valve-in-valve intervention, pre-procedure planning with imaging studies should be conducted to minimize risks such as coronary obstruction.
For patients, you should not panic but you do want to talk to your doctor and the best and safest path moving forward. It is unfair that you have to deal with this on top of everything else you have been through.
Negative effects associated with the Abbott heart valve replacements must be reported quickly to the FDA’s MedWatch safety system so the FDA and Abbott know what is going on with patients.