In the past, heart valve replacement required cardiothoracic open heart surgery, stopping the heart, and a perfusionist running a coronary bypass machine. This was extremely invasive with associated complications and recovery. Newer procedures have been developed, making many of these surgeries a thing of the past. In fact, according to Ron Waksman, M.D., associate director of the division of cardiology and director of cardiovascular research and advanced education at Medstar Heart and Vascular Institute, it is expected that by 2025, 75% of the aortic valve replacements will be done with the new TAVR technique. 

The TAVR procedure is similar to Percutaneous Intervention (PCI) where a stent is placed. A wire is guided into an artery, then threaded up to the heart. The new valve is inserted into the old one, then expanded. This pushes the native valve out of way and the new valve starts working immediately.  The entire procedure takes about two hours. 

Previously, the Food and Drug Administration approved this fairly new procedure only for people with symptomatic aortic stenosis, who were considered an intermediate or high risk patient for standard valve replacement surgery. On August 16, 2019, the FDA approved the procedure for all risk categories – low, medium, and high. The FDA simultaneously expanded the indications for use for both the Edwards Lifesciences’ Sapien 3 valve and Medtronic’s CoreValve Evolut system for this patient population. 

This procedure isn’t risk free.  Complications associated with these devices include death, stroke, acute kidney injury, heart attack, or bleeding. There have been cases where the patient needed a permanent pacemaker after the procedure. However, it certainly looks like a better option than open heart surgery. 

To learn more about TAVR, check out the links below:

• FDA Release: FDA expands indication for several transcatheter heart valves to patients at low risk for death or major complications associated with open-heart surgery
• American Heart Assocation: What is Transcatheter Aortic Valve Replacement?
• Medtronic: TAVR Procedure – Transcatheter Aortic Valve Replacement (TAVR)
• Diagnostic and Interventional Cardiology: FDA Approves TAVR for Low-risk Patients Creates A Paradigm Shift in Cardiology
• Image Credit: College of Medicine Tuscon – Surgery