As we learned last Thursday, the FDA just approved the new SAPIEN transcatheter aortic valve replacement for inoperable patients. This exciting announcement has left many patients and caregivers wondering why the SAPIEN is only for inoperable patients in the United States.

At the recent Heart Valve Summit, I was able to discuss this important topic with Dr. Lars Svensson, one of the leading heart valve surgeons at The Cleveland Clinic. Here are the highlights of Dr. Svensson’s response to Cory’s question, “Why are the new transcatheter therapies only for inoperable patients?”

For the patients and caregivers of our community who are hearing impaired, I have provided a written transcript of this video interview below.

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I don’t know about you… But, when I was diagnosed with severe heart valve disease, I experienced several dislocating emotions. One of those emotions was confusion. As my cardiologist reviewed my echocardiogram, he used medical terms that were foreign to me.

To help future patients avoid a similar situation, I recently interviewed Dr. Randy Martin — the past president of The American Society of Echocardiography and Chief of Valvular & Structural Heart Disease at Piedmont Heart Institute — during the Heart Valve Summit. During our chat, Dr. Martin answered Ken’s question, “What is the most important diagnostic element prior to mitral valve surgery?”

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Big, big, big, biggggggg news everybody!

I just learned that the Edwards SAPIEN Aortic Valve has received FDA approval for “inoperable” patients. On the heels of this exciting announcement, there are several implications for patients and caregivers that should be considered.

Edwards SAPIEN Heart Valve Replacement

First… This is the first time that a transcatheter therapy has been approved by the FDA for aortic valve treatment. Using SAPIEN, physicians deploy a catheter-based delivery system to replace a diseased aortic valve without any incision to the patient’s sternum or ribs.

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The possibilities of transcatheter valvular therapy are exciting. However, these minimally-invasive approaches to treating heart valve disorders are new and still without FDA approval in the United States. That said, my inbox is filled with patient and caregiver questions about devices including the CoreValve, the SAPIEN and the MitraClip.

For example, Gayle recently sent me an email asking, “Adam — Can patients with a failed mitral valve repair be eligible candidates for the MitraClip?” At the recent Heart Valve Summit in Chicago, I asked Dr. Steven Bolling, the Director of The Mitral Valve Program at the University of Michigan, this exact question. Here are the highlights from our discussion.

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