More than 11 million people in the U.S. are estimated to have heart valve disease, and more than 25,000 Americans die from heart valve disease every year. For George Dean, 66, his aortic valve stenosis was not symptomatic, but it had gotten progressively worse in the decade since it was initially diagnosed, from mild to severe.
In June 2020, George received a SAPIEN transcatheter aortic heart valve as part of the Minneapolis Heart Institute Foundation’s (MHIF) participation in the EARLY TAVR clinical trial for the device, which is manufactured by Edwards Lifesciences. The clinical trial is a randomized study where eligible patients who have severe aortic stenosis but are asymptomatic receive either a transcatheter aortic valve replacement (TAVR) with the valve or clinical surveillance.
Aortic stenosis is one of the most common valve diseases and usually develops later in life. It occurs when the aortic valve becomes narrow and obstructs the flow of blood from the heart to rest of the body. When the aortic valve gets very narrow, the heart has to work harder to pump the blood around the body. As a result, the heart muscle gets thicker, stiffer and, over time, weaker, which is called heart failure.
“The funny thing is that I was asymptomatic,” said George. “I wasn’t feeling fatigued. I wasn’t feeling winded. In fact, I was continuing to ride my bike and feeling pretty good. I’m a consultant by trade, so I went back and looked at the data over the last 10 years and put together a table of all of my echocardiogram results. You could see year by year, they progressively got worse. I spoke with my primary care provider Dr. Mark Stevenson and my cardiologist Dr. Alex Campbell and they both said, ‘You’re going to have to get it done at some point. The positive of getting it done early as part of this clinical trial is that you can limit any further damage to your heart and other organs. You may not be feeling the symptoms yet, but they’re coming.’”
George had never participated in a research trial before, so was initially hesitant, but after doing his own research and the thorough education from the research team on the device, procedure, benefits and risks and the study’s five-year follow-up schedule, he decided to participate.
“I just decided I’m going to take the short-term risk for the long-term gain and it was just a great experience,” said George. “Dr. Santiago Garcia and his team were just fantastic, and the people at Abbott Northwestern — from the nurses to the procedure operating room nurses, and just across the board — it was just a great team. From March through my postoperative checkup on July 27, there were nearly 25 people on the team that, at one point or another, had provided services to me. I can’t say enough good things about them. I mean, their skill. They care about you. They are passionate about what they do.”
He continued, “The procedure itself, I think the whole thing took about 45 minutes. I was kind of semi-conscious, sedated. I can remember some things, not others. No pain. I was in my hospital room a couple hours later, and I checked out the next day. So, I was home less than 24 hours after I received the new aortic valve. When you think of the technology and how technology has progressed over the years, it’s just amazing.”
Four weeks after surgery and into his cardiac rehab program, George was back exercising daily on his Lifecycle downstairs, and said, “I’m back. I’m exercising at the same level that I was two days prior to the procedure, and I feel much better. I have more energy. The big improvement comes when you’re like 30 minutes into a Lifecycle going at about 14 miles per hour, and your legs feel great. Your legs feel better than they did prior to the procedure, and it feels like you have an extra oxygen tank feeding your blood. That’s where I’ve really noticed a difference. I’m glad I had it done.”
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