TAVR in Degenerated TAVR Valve Feasible, Safe in 'No Option' Patients

October 20, 2020

When a surgical aortic valve prosthesis degenerates, the patient— older, perhaps sicker, and no longer a good candidate for surgery — has a valve-in-valve alternative in the form of transcatheter aortic valve replacement (TAVR). But it's been unclear whether a second TAVR can be an effective fix for patients with aged, failing TAVR valves.

Such "TAVR in TAVR" indeed can be successful with relative safety, suggests a small registry study of patients with failed transcatheter valves who had been at intermediate to high surgical risk when they underwent their first procedure 3 to 4 years earlier. All were thought to have exhausted other good treatment options and so had been offered a second TAVR.

Luca Testa

The early findings from the TRANSIT registry, which includes some patients who were among the earliest to receive TAVR valves, should be "quite reassuring for both patients and physicians," Luca Testa, MD, told theheart.org | Medscape Cardiology.

For such patients and candidates for the procedure today, regardless of their surgical risk, the results "support the concept that a degenerated TAVR can be safely and successfully treated by means of a second TAVR," said Testa, from the Institute of Hospitalization and Scientific Care, San Donato Polyclinic, Milan.

Testa presented the TRANSIT registry analysis October 17 during TCT Connect, the virtual edition of Transcatheter Cardiovascular Therapeutics (TCT) 2020.

The study included all 172 patients who underwent TAVR for a degenerated TAVR valve at 28 mostly European centers from 2008 to this year, out of the approximately 40,000 primary TAVRs performed at those institutions. None of the new procedures were to treat TAVR valves that had failed acutely at implantation.

All patients were considered to be at intermediate to high surgical risk at their first TAVR, and all were at high surgical risk at the time of their second TAVR, with a mean age of 80 years, about 70% with NYHA class 3 to 4 heart failure, and prevalent renal disease. By then, medical therapy wasn't effective "and surgery had been rejected years before," Testa said.

The transfemoral approach was used in 92%, and only about 10% of the second procedures involved a transcatheter cerebral protection device.

The degenerated valves were overwhelmingly Corevalve Evolut R (Medtronic) and Sapien XT (Edwards Lifesciences) devices, which were by far the dominant TAVR valves used during the years covered by the analysis, Testa pointed out.

"The numbers of patients having a degenerated TAVR valve will increase steadily every year," he said. In the years since the TRANSIT patients received their first TAVR, the procedure has extended to a wide spectrum of patients almost regardless of their suitability for surgical aortic valve replacement (SAVR) based on operative risk.

That means "we will be even more often treating patients who are low risk, in their 60s and 70s, who have a high chance of outliving their bioprosthesis," Testa said. Now, there is evidence physicians can show patients that if a first TAVR fails "in the next 10 years, for example, we can do it again, safely and effectively."

The findings have implications for valve replacement going forward, whether in the operating room or cath lab. "It follows that physicians should start thinking that a relatively young and low-risk patient, one who does not receive a mechanical SAVR, could be treated either with biological SAVR or a TAVR," Testa said in an interview. If either should fail in the future, there is an effective transcatheter treatment.

That could change the entire decision process when the choice for a first procedure could be either SAVR or TAVR in what may well be a younger, low-risk patient. Such decisions, he said, should consider the current data.

"For patients at relatively low surgical risk, like some of those treated nowadays, SAVR can be an option. However, I would not consider a more invasive approach when a less invasive one is feasible and effective. Moreover, we do not have evidence that a surgical bioprosthesis has longer durability," Testa said.

In the current series, the prevalence of NYHA class 3 to 4 heart failure went from 73.5% before the TAVR in TAVR, to only 7.0% after 30 days and 12.8% after 1 year. All-cause mortality was 2.9% at 30 days and 10.0% at 1 year; cardiovascular mortality at 1 year was only 5.8%.

Also at that time, 1.2% had experienced a myocardial infarction (MI), 3.5% a stroke, 1.4% valve thrombosis, and 11.0% a new heart-failure hospitalization; none required reintervention for valve failure.

Several invited discussants, speaking after Testa's formal TRANSIT presentation, had their doubts about going with a second TAVR, especially in future patients who might also be candidates for SAVR. "Maybe there's something about the constellation of this patient as to why they're presenting 2 years after their TAVR with a failed valve," said one of those discussants, Michael A. Borger, MD, PhD, Leipzig Heart Center, Germany.

"Just like if we see a patient who received a mechanical surgical valve, and they come back with a valve thrombosis, we operate and we put in a biological valve. There's something about them that they're not tolerating the valve well, and I'm not sure it's the best strategy to go ahead and put a second valve in."

Another discussant, Vinayak N. Bapat, MD, said, "I'm less optimistic because of this. All the patients had successful TAVR and had essentially a procedure within 2 to 4 years."

The second TAVR's postprocedure aortic valve area is always going to be smaller than after the first TAVR, even if the second procedure goes well by usual standards, observed Bapat, from the Minneapolis Heart Institute at Abbott Northwestern Hospital. "These patients are invariably going to come back within the next 2 or 4 years for another procedure."

For many of the low- to intermediate-risk patients who undergo TAVR today, especially younger ones, whether SAVR or TAVR is more appropriate for a failed first TAVR would need testing in trials, Testa said. But for TAVR patients today who are in their 80s, for example, "we need to know more about the possibilities if the patients outlive their prosthesis. In that sense, I would say this registry is pretty reassuring."

One issue for exploration, he said, is that patients with failed TAVR valves are heterogeneous and current risk scores don't necessarily consider everything that might predict whether a TAVR in TAVR would be helpful. "I believe these are seminal data," Testa said, but the cohort should be analyzed further to determine whether those who will benefit most can be identified earlier.

TCT Connect is sponsored and run by the Cardiology Research Foundation, which, it frequently notes on the meeting site, "gratefully acknowledges the educational grant support from the 'Major Benefactors' Abbott, Boston Scientific, Edwards, and Medtronic," among other companies. Testa had nothing to disclose. Borger discloses receiving consultant fees or honoraria or serving on a speakers bureau for Edwards Lifesciences, Medtronic, Abbott Vascular, and CryoLife. Bapat discloses receiving consultant fees or honoraria or serving on a speakers bureau for Edwards Lifesciences, Medtronic, Boston Scientific, 4C, and Admedus.

Transcatheter Cardiovascular Therapeutics (TCT) 2020. Presented October 17, 2020.

Follow Steve Stiles on Twitter: @SteveStiles2. For more from theheart.org | Medscape Cardiology, follow us on Twitter and Facebook.


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