Heart Valve Summit Video #4: “Why Are The New Transcatheter Therapies Only For Inoperable Patients?” Asks Cory
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, MD, 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.
Thanks to Cory for his question. I would also like to extend a special “Thank you!” to Dr. Lars Svensson for his ongoing pursuit of healthy hearts. Doctor Svensson has been intimately involved in the development, clinical use and FDA trials of several technologies that enhance valvular treatment for patients around the world.
- To learn more about Doctor Lars Svensson, please click here.
Keep on tickin!
P.S. Here is the video transcript:
Adam: “Hi everybody, it’s Adam. We are at the Heart Valve Summit in Chicago, Illinois. We’re answering your questions that were posted at HeartValveBlog.com. Very excited to be standing next to Dr. Lars Svensson, MD, who is the director of the Aorta Program and Quality at The Cleveland Clinic in Cleveland, Ohio. We have a question that came in from Cory, Dr. Svensson, and the question is, “Why is it that all new transcatheter therapies are only for inoperable patients? Can’t we all benefit from them?”
Dr. Lars Svensson: “That’s a very good question and obviously we’d love to introduce all new technologies, that appear to be working, to all patients, but the FDA has mandated, and rightly so, that we test progressively devices in lower risk populations over time.
Dr. Lars Svensson, The Cleveland Clinic
So the first study that came out, with the percutaneous valves, the Partner B, as it’s called, was in patients who were inoperable for the traditional surgery, in other words, patients who weren’t being treatment. So in a sense there was the potential for great benefit in patients who had no other options. And as far as risk assessment on those patients one can, in a sense, be a bit more forgiving about the risks in that population, because they had no option.
SAPIEN Aortic Valve Replacement (Edwards Lifesciences)
But, as we progressively have looked at lower risk patients, Partner A was a trial that we reported earlier that was in a high risk population. In the Partner B, the inoperable patients, there, in a sense, the media message was very easy.
We improved survival in these patients by two-thirds, 67% in two years. Fantastic result, really good, no other option, we did a great job. In the Partner A, which was the high risk surgical, there we were looking at the comparison with open surgery. So the headline is not so catchy, but really what it is, is that the percutaneous valves were equivalent to open aortic valve replacement, as far as survival or dying with the operation, at a slightly higher risk of neurological events, particularly stroke and TIA’s. And the reason why we then cannot open it up, in a sense, to everybody is; first of all, we don’t know what is going to happen in a younger population.
In a younger population you have the demand on the valve, working for a longer time. And we know, in that population, the results with open surgery are really excellent. We looked over a seven year period in the 2000’s in our patients, less than the age of 70, having a first time aortic valve replacement at The Cleveland Clinic, and the risk of death was .27%. Now that wasn’t just a fluke, looking at all of our quality data, obviously, at the clinic, for all patients, who had an aortic valve replacement of an aortic valve plus coronary bypass, for the first 6 months of this year. We did 398 patients for those operations. There was only one death, so .25%. Three patients had strokes, 1% risk of stroke.
So, the new technology has had a higher stroke rate and we want to reduce that before we introduce it to younger patients. And, I think we are going to do that, the new devices that are becoming available to use together with the percutaneous valves, I think will reduce that risk. So it’s a fine balance, the FDA has to look at the risks of the procedure, the devices versus the safety and the benefits. So the FDA is in a difficult position in rolling out these two technologies to everybody.”
SAPIEN Catheter Delivery System (Edwards Lifesciences)
Adam: “Got it, well Cory, I hope that helped you. I know it helped me learn more about how eventually we are going to be seeing these new technologies roll out in the new future. And, I want to acknowledge you, Dr. Svensson, for all the work that you are doing, these new revolutionary technologies, whether it is transcatheter, I know about the recent ValveXchange leaflet replacement system you did in Paraguay. It’s really just a testament to what you are doing and your pursuit of healthy hearts. And I know a lot of our patients have come to you and they’ve had great results. And so I just want to thank you for taking the time to share your expertise with us.”
Dr. Svensson: “My pleasure. Good talking to you.”
Adam: “Keep on tickin!”
Adam Pick is a patient, author of The Patient's Guide To Heart Valve Surgery and the founder of HeartValveSurgery.com.