VIDEO: The state of TAVR in 2022
Michael Mack, MD, chairman of the cardiovascular service line, Baylor, Scott, White Health, cardiac surgeon, and a key pioneer in transcatheter aortic valve replacements (TAVR), explains the history of TAVR and where things are headed during the 2022 Transcatheter Valve Therapeutics (TVT) structural heart summit.
TAVR in 2022 makes up about 84% of the aortic valve replacement procedure volume, Mack said. And while surgical aortic valve replacement (SAVR) has dropped to 16% of aortic replacements, Mack said larger numbers of patients are being referred for valve replacements than 10 years ago, so cardiac surgery numbers have not really decreased.
In 2021, there were 92,000 TAVR valve implanted in patients in the United States. The lines for procedural volumes between SAVR and TAVR crossed in 2018, as TAVR pushed beyond the 50% mark, Mack said.
"The evidence base is strong, especially against the comparative standard-of-care of surgery, so it is hard to argue with the data," Mack explained.
He gives a lot of credit to the FDA for holding the bar high in the pivotal trials, which really powered the movement to adopt TAVR nationwide in the wake of the great clinical trial evidence.
"This included more than 9,000 randomized patients in the United States, in descending order of risk, and the data clearly demonstrated the benefits," Mack said. "That is why the adoption has been so wide, because the evidence is so strong."
Mack also said TAVR is an easily teachable procedure, and the vendors have helped facilitate training on it.
Surgery is still considered the standard of care in younger patients because no synthetic valve can last as long as most younger patients will live. Mack said ideally a patient should get a surgical valve, followed by two later TAVR valves. He said one of these procedures needs to be a surgical replacement – and patients do much better with this the younger they are – while TAVR can be used in very sick and elderly patients who have a higher surgical risk score.
Surgical valves are considered the most durable, with 10-12 years of durability before they will start to degrade and need to be replaced. It was widely thought that TAVR valves, with thinner leaflets and a frame that needed to be crimped into a catheter, would not have very good durability. However, data continues to show TAVR valves do have good durability. The latest data on the Medtronic Core valve at the American College of Cardiology (ACC) 2022 meeting shows the durability with TAVR was out-performing SAVR valves.
While TAVR has been a paradigm shift in how cardiac patients are treated, the bigger legacy is likely the creation of the heart team. The deep collaboration between surgeons, interventional cardiologists and cardiac imagers resulted in the need for heart teams to discuss patient cases similar to a tumor board to decide together what is best for the patient, pre-planning the case and live imaging to guide the procedure.
"As big as a game changer as TAVR has been, I think the heart team concept might be an even bigger legacy that has happened out of all of this," Mack explained.
Cardiac surgical volume is not declining despite growth in TAVR
He said as more people wanted referrals for TAVR rather than open heart surgery, numbers of patients being seen by heart teams have skyrocketed in recent years. And many of these younger patients are better candidates for SAVR. Mack explained that prior to TAVR, many patients were screened and did not qualify for surgical valve replacements, but the surgeons did not realize this and just assumed they were treating the entire treatable population of valve replacement patients. Today, with TAVR, that population of treatable patients has greatly expanded, resulting in many more referrals than in previous decades. Mack said the valve replacement candidate population is still not completely known because it continues to grow beyond all previous estimates
"Surgical volumes have not declined and they are actually beginning to tick up again," Mach said. "Ten years ago cardiac surgery was seen as a dying subspecialty, but the number of cardiac surgical residents is using again. There are now more applicants than there are positions available."
Mack said surgery is not going away and noted that 65% of cardiac surgeries are still coronary bypass graft (CABG) procedures.
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Dave Fornell has covered healthcare for more than 17 years, with a focus in cardiology and radiology. Fornell is a 5-time winner of a Jesse H. Neal Award, the most prestigious editorial honors in the field of specialized journalism. The wins included best technical content, best use of social media and best COVID-19 coverage. Fornell was also a three-time Neal finalist for best range of work by a single author. He produces more than 100 editorial videos each year, most of them interviews with key opinion leaders in medicine. He also writes technical articles, covers key trends, conducts video hospital site visits, and is very involved with social media. E-mail: dfornell@innovatehealthcare.com