This past week, the Food and Drug Administration approved the Edwards LifeSciences Sapien 3 trans-catheter heart valve (image 1) for use in patients who are at intermediate risk for complications from traditional open valve surgery. What does this mean? Well, a decade ago the only solution for patient with aortic valve stenosis was open valve surgery performed by a highly skilled cardio-thoracic surgeon using a thoracotomy (surgical incision through the chest wall). Aortic stenosis is a medical condition that results in obstruction of the aortic valve that separates the main pumping chamber of the heart from the rest of the body. Plain and simple, this is a mechanical problem that requires a mechanical fixing.
Aortic Stenosis is a Mechanical Problem
There is no medical therapy for this condition. Since that advent of “stents” for valves the procedure had evolved from a traditional valve replacement to an aortic valve implant or TAVI (trans-aortic valve stent implantation). Initially, the procedure was reserved for patients who were at the highest risk of complications from traditional surgery. More often the patients tended to be riskier due to the presence of other medical conditions like bad lungs or a weak heart muscle to name a few. This limited to a large extent the dissemination of the technology to some patients that were not high risk for surgery but intermediate risk or low risk. But now, both hig
h and intermediate risk patients qualify for this break-through technology that can be delivered through multiple artery access sites (most commonly the femoral artery) and avoids traditional open surgery.
Who Qualifies for this Procedure?
So who qualifies for this procedure now? Anyone who is at high surgical risk 8% or intermediate surgical risk 3% based on a surgical scoring system that is reviewed by a heart team comprised of multiple specialities and nursing coordinators responsible for ensuring the most appropriate patients are selected and the best procedure is chosen to ensure the best possible outcome for the patient (image 2). This approach has not only been validated and used in clinical trials testing these technologies but represe
nts the best medicine has to offer when it comes to caring for complex cardiovascular patients. Moving forward the FDA is requiring post market approval registry for patients that undergo this procedure to ensure the real world results are as good as recent studies have shown comparing stenting and surgery. The FDA has also approved valve stents to now be tested in “low” risk patients which means that one day stenting valves will likely become as safe and as common as stenting arteries.