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.
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