Med Device Monday: Expanded Use for a Heart Valve

Heart disease is one of the most common illnesses in the United States. As I mentioned last month, it is in fact the number one killer of women. Aortic stenosis is one of the most common types of heart disease. 

Per the American Heart Association, "Aortic stenosis is one of the most common and most serious valve disease problems. Aortic stenosis is a narrowing of the aortic valve restricts the blood flow from the left ventricle to the aorta and may also affect the pressure in the left atrium. Although some people have AS as a result of a congenital heart defect called a bicuspid aortic valve, this condition more commonly develops during aging as calcium or scarring damages the valve and restricts the amount of blood flowing through the valve." The problem typically worsens with age as the valve continues to restrict blood flow. The video further illustrates the basics of AS.

Aortic stenosis is not always symptomatic. When it is, it often presents as chest pain, dizziness, light-headedness, fainting, palpitations, inability to exercise as one did before, etc. When asymptomatic, it often can be left untreated. But when treatment is required, a valve replacement is often in order. A few months ago, FDA announced approval of expanded use for an existing heart valve. The approval allows for usage of Sapien XT and Sapien 3 transcatheter heart valves to be expanded from use only in patients who are at high or greater risk of needing open heart surgery, to those at intermediate risk. These valves are inserted via the femoral artery in the groin and thus do not require the more risky open heart surgery. Per the announcement, "Traditionally, open-heart surgery has been the gold standard for aortic valve replacement in intermediate risk patients, but it involves a larger incision and longer recovery time than the minimally invasive procedure used to insert the transcatheter heart valve. About one-third of patients referred for open-heart surgery for aortic valve replacement fall into the "intermediate risk" category, which is defined as having a greater than three percent risk of dying with 30 days following surgery." 

The expanded category of use means that fewer people may have to undergo open heart surgery, which can be dangerous and carries the risk of various complications. Potential risks of open heart surgery range from infection to arrhythmia to damage to the heart, liver, kidneys, and lungs. The expanded approval of use is fantastic news indeed. Not only that, but this procedure also has better outcomes than the traditional surgery.

The company who makes these valves, Edwards, elaborates in their press release: "The intermediate-risk approval of the SAPIEN 3 valve is a major milestone, since it provides a less-invasive therapy that has demonstrated better outcomes for aortic valve patients, and is supported by the largest and rigorous comparative body of evidence for the treatment of aortic stenosis," said Larry L. Wood, Edwards' corporate vice president, transcatheter heart valves."

Screenshot from

Screenshot from

They go on to explain that body of evidence: "The SAPIEN 3 valve intermediate-risk approval was based on data from a cohort of the PARTNER II Trial, which studied 2,005 intermediate-risk patients at 51 sites in the United States and Canada. The study demonstrated that patients treated with the SAPIEN 3 valve experienced clinically significant improvements for the composite primary endpoint of mortality, stroke and moderate or severe aortic regurgitation at one year as compared to those treated with surgery.  The data were presented in April at the American College of Cardiology's 65th Annual Scientific Session and simultaneously published in The Lancet

The expanded intermediate-risk indication granted by the FDA enables Heart Teams to treat patients with the SAPIEN 3 valve who they determine to have a predicted risk of surgical mortality of greater than or equal to 3 percent at 30 days, based on the Society of Thoracic Surgeons (STS) risk score and other clinical co-morbidities unmeasured by the STS risk calculator."  

This really is exciting news, and I look forward to seeing how treatment of heart disease continues to grow more safe and effective in the future–especially with the help of medical devices!


You can read the Pre-Market Approvals for the original use as follows: 

PMA for Sapien 3 Transcatheter Heart Valve and Accessories

PMA for Edwards Sapien XT Transcatheter Heart Valve and Accessories 

PMA for Edwards Sapien Transcatheter Heart Valve and Accessories

PMA for Edwards Sapien Transcatheter Heart Valve and Accessories (with Clinical Trials)