By James E. Harvey, III, MD, MSC, FACC, FSCAI, interventional cardiologist at WellSpan Health
Transcatheter aortic valve replacement (TAVR) has advanced steadily and significantly since it was first approved in 2011. But many providers are unaware of how much it has advanced and which patients are eligible.
James E. Harvey, III, MD, MSC, FACC, FSCAI,
WellSpan Health has an especially close relationship with this procedure. Some colleagues and I developed the cusp overlap technique for implanting transcatheter (non-surgical) heart valves, which is now the gold standard for delivering self-expanding transcatheter heart valves on the market today.
We perform about 400 TAVRs annually, with a mortality rate consistently below 1% — despite seeing a higher proportion of acute and complex cases. Our expertise is recognized globally, and I've had the privilege of educating numerous interventional cardiologists and cardiac surgeons worldwide.
Last year, I was the primary investigator for two studies that showed just how far TAVR has come in the past 15 years: TAVR outcomes are significantly improving across the country, and this includes a historic drop in the need for pacemakers following surgery.
With strides like these, every patient with severe aortic stenosis can feel confident about their options — whether they’re 60 or 90, and whether they have symptoms or not.
Total complication rate cut in half
The research we led last year focused on complication rates. The first study looked at a range of complications across 200,000 patients who underwent either surgical or transcatheter valve replacement over the first eight years TAVR was available.
This was a period of rapid innovation, with physicians refining their techniques and the device companies improving their designs. As a result, the total complication rate for TAVR dropped by more than half, from 41% to 19%.
Historic drop in patients needing pacemakers
The other study focused on a specific complication: permanent pacemaker implantation (PPI) after surgery. Pacemakers are sometimes necessary because of damage to the heart’s electrical conduction system, which runs right next to the aortic valve. That damage can occur naturally from the same disease that causes aortic stenosis. But it can also result from swelling or injury during TAVR.
I’ve long been confident that you can reduce that damage with better technique and technology. The PPI rate at WellSpan Health is roughly 5%. The question is: Have the advancements we adopted spread enough to make a difference nationwide?
Our PPI study proved they have. We looked at more than 50,000 TAVR patients who received Evolut self-expanding transcatheter heart valves — the same type for which we developed the cusp overlap technique for implantation. We found that across the United States:
- The 30-day PPI rate decreased from 16.6% to 10.8%
- The in-hospital rate decreased from 14.7% to 8.8%
This in-hospital rate marks the first time a nationwide PPI rate dropped below 10% — a major milestone for TAVR, and a reassuring sign that innovations we launched at WellSpan Health are improving care across the country.
Who’s a good candidate for TAVR?
TAVR was initially reserved for patients who weren’t eligible for open surgery, but now it’s approved for any patient with severe aortic stenosis and appropriate anatomy. That includes patients who don’t yet have symptoms — a new addition last year — and other patients who typically aren’t candidates for surgery.
I once implanted a 95-year-old farmer. He went home the next day and looked as healthy as ever at his three-year check-up. I also performed a TAVR for a 62-year-old physician. He had a bicuspid valve, which at the time usually meant open surgery. But he was an avid runner and wanted to avoid an invasive procedure with a long recovery. He is thriving today and will likely get decades out of his artificial valve.
Severe aortic stenosis affects hundreds of thousands of new patients each year, and it can be fatal if untreated. It’s important for PCPs to refer as soon as signs of stenosis emerge.
- If a patient has symptoms and a severely narrowed valve, they’re already late.
- If a patient has no symptoms, they can choose to wait to have their valve replaced, but we’ll still do the workup. Research on asymptomatic patients showed that 87% of the “wait and see” group ended up needing TAVR sooner than later … and when they do, they need it quickly.
If a patient isn’t severe yet, we won’t do surgery, but they’ll be on our radar — and we’ll be ready to help as soon as they need it.