This is part of a series of “Implant Files” stories, which are based on the findings of an international coalition of journalists that raise serious concerns about the safety of certain medical devices.
Artificial heart valves are increasingly used nationwide, even though the durability and true health risks associated with procedures remains uncertain, according to the findings of a recent investigative report.
Researchers with the International Consortium of Investigative Journalists (ICIJ), as part of a global investigation into the medical implant industry, say there may be reasons to be concerns about transcatheter aortic valve replacement (TAVR) procedures, which have grown in popularity in recent years.
Artificial heart valves are widely used to treat aortic stenosis, a narrowed heart valve. The TAVR procedure was originally targeted at older patients, when aortic stenosis is most common. However, the report found that the procedure and artificial heart valves are increasingly being used on patients who are younger and healthier.
The problem is that no one is sure if the devices will last for the lifetime of these younger patients; not doctors, researchers or even the manufacturers who make them, according to the report.
A number of studies have indicated that patients who receive TAVR valves face a higher risk of death than those who undergo the more extensive open-heart surgery for surgical valve replacement, according to the findings of the recent investigation.
However, that hasn’t stopped the manufacturers like Medtronic and Edwards Lifesciences from launching marketing efforts designed to convince cardiologists that there is nothing to worry about. Not only have the companies directly marketed to doctors with advertisements, but they’ve also dumped money into patient advocacy groups.
The report indicates that Mended Hearts, a group established for hospitalized heart disease patients, has members appear in Edwards Lifesciences promotional videos and advocates for the TAVR procedure at gatherings. The group received nearly $300,000 from Edwards, and more than a million dollars overall from drug and medical device companies in 2016.
As a result, doctors say patients often ask for TAVR valves, regardless of whether they are the best option or not, and the TAVR market is expected to rise to $5 billion by 2021.
Doctors stress that the artificial valves most certainly save lives. It is also highly attractive because the valves are implanted through non-invasive surgery, which usually implies less health risks and a shorter recovery time.
However, with their original design being for older patients, and their relatively new popularity, the artificial heart valves have not been on the market long enough for people to know how long they’ll function in patients. Doctors say they are currently making decisions about whether to recommend TAVR procedures over risky open-heart surgery without good data on long-term risks for younger patients.
Manufacturers are still researching the data, but time needs to go by to see how the recipients are doing. TAVR valves were first approved in 2007. The devices were first approved in Europe, which ICIJ reporters found to be more lax in medical device approval than the FDA in the United States.
The early valves were larger and linked to higher rates of death among patients. From 2009 to 2010, 7.6 to 9.2 percent of patients in Germany who received the valves died during the hospital stay afterwards. That mortality rate is down to two percent.
The FDA required the manufacturers to run clinical trials, which were not conducted in Europe. Patients in those trials had an 11.2 percent stroke rate in the first year, compared to a stroke rate of only 4.5 percent in surgical valve patients.
Despite those risks, the agency approved Edwards’ Sapien valve on 2011 and Medtronic’s CoreValve in 2014, but only for high-risk patients who might die within 30 days without them. However, doctors are allow to use both drugs and devices for whatever needs they see fit, and have increasingly implanted the valves in patients of lower and lower risk.
In a statement to ICIJ, Edwards noted that a series of studies are underway to evaluate the use of the valves in low-risk patients.
Since 2007, more than 350,000 patients have undergone TAVR procedures.