Heart valve disease leads to about 20,000 deaths in the US a year. To save these patient’s lives, the valves are repaired or replaced.
The conventional heart valve replacement has been performed more than 95,000 times since its introduction and has saved thousands of lives. However, this well-established procedure has its disadvantages, especially its invasiveness. Conventional valve replacement requires open heart surgery, and therefore comes with a lot of complications, general anaesthesia, and longer hospital stay and recovery period. This is why not all patients with narrowed heart valve are not qualified to have the replacement procedure due to the risks involved. About one-third of patients with heart valve disease, e.g. those with severe disease and advanced age cannot undergo to this procedure.
The percutaneous heart valve replacement is a more recent and less invasive procedure wherein the replacement valve is implanted through a catheter rather than by open heart surgery. First introduced in 2002, it is less invasive and it is suitable for patients who are very sick or elderly and cannot withstand open-heart surgery. The operation time as well as recovery and rehabilitation period are much shorter. Thus, this emergent heart valve replacement technique has become very popular.
However, a new study funded by the US Department of Health & Human Services’ (HHS) Agency for Healthcare Research and Quality (AHRQ) warns that although the new procedure seems to be safe and effective, very little is known about the potential long-term risks and benefits of the procedure and that more research is needed before the new procedure can truly replace the conventional heart valve replacement.
The report gives us the following figures:
- About 92% of patients who underwent percutaneous valve replacement survived the procedure
- About 86% survived for at least 30 days.
USA Today reports about a study led by Dr. Ted Feldman of North Shore University Health System in Evanston:
“Only 9.6% of patients in the device group had complications within 30 days; 12 had enough blood loss to warrant transfusion. In contrast, 57% of surgery patients had complications, including two deaths, two strokes and four patients who needed emergency surgery.”
The percutaneous heart valve replacement has been in use in Europe for almost 2 years now and was only recently used in the US, with only one valve, the Medtronic Melody Transcatheter Pulmonary Valve and Ensemble Delivery System, currently approved by the U.S. Food and Drug Administration. The new procedure seems very promising. However, it is only right to be prudent and cautious when it comes to important medical procedures such heart surgery. That is why health authorities in the US are calling for more research to clarify the safety of the technique.
According to AHRQ Director Dr. Carolyn M. Clancy:
“As the U.S. population ages, the number of patients with heart valve disease will increase, so more Americans will need options for safe, effective heart valve replacement. This report identifies what is known about this emerging procedure and where the research is lacking to give patients more options about their treatment.”
The percutaneous heart valve replacement gives hope to many heart patients and we are crossing our fingers that its efficacy and safety will be tested and proven in the long-term.