Reassuring Real-World Data on Redo TAVR
Megan Brooks
September 15, 2023
Repeat transcatheter aortic valve replacement (TAVR) with a balloon-expandable valve is effective in treating a failed first transcatheter valve, with low procedural risks and with clinical outcomes comparable to those with first TAVR in a native valve, results of a registry study suggest.
Redo-TAVR was effective in restoring aortic valve function and treating both aortic stenosis and aortic regurgitation associated with first TAVR failure.
Rates of death or stroke at 30 days or 1 year were no different between patients undergoing redo-TAVR or native-TAVR in a matched population with similar clinical profile.
The clinical outcomes of redo-TAVR with balloon-expandable valves were not affected by early or late timing of the redo procedure or the type of the first transcatheter valve implant.
"These data are reassuring because younger patients are undergoing TAVR procedures and will outlive the durability of their first valve. This gives patients to avoid open heart surgery and address this with less invasive procedure," senior author Raj Makkar, MD, with Smidt Heart Institute, Cedars-Sinai Medical Center, Los Angeles, California, told theheart.org | Medscape Cardiology.
The study was published online August 31 in The Lancet.
Predicted Increase in Repeat TAVR
With an increasing number of patients undergoing TAVR, including younger patients, data on management of failed TAVR, including repeat TAVR procedures, are needed, the researchers note.
Makkar and colleagues analyzed data on all consecutive patients in the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Replacement Registry who underwent TAVR with a balloon-expandable valve over roughly 11 years (2011–2022).
Among all 350,591 patients, there were 1320 (0.4%) redo-TAVR procedures. The researchers compared procedural, echocardiographic, and clinical outcomes between 1320 propensity-matched pairs of patients undergoing redo-TAVR and native-TAVR.
Among redo-TAVR patients, the mean age was 78, 58% were men, 82% had NYHA class III or IV symptoms, and the mean predicted surgical risk of 30-day mortality was 8.1%.
"Despite advanced age, high baseline surgical risk and theoretical concerns about the feasibility of redo-TAVR," procedural complications were "rare" and were similar to native-TAVR, the investigators report.
Rates of conversion to open heart surgery, need for cardiopulmonary bypass, coronary compression or obstruction, and aortic root injury were less than 1%. There were eight (0.6%) intraprocedural deaths.
There was no significant difference between redo-TAVR and native-TAVR populations in death at 30 days (4.7% vs 4.0%, P = .36) or 1 year (17.5% vs 19.0%, P = .57), and stroke at 30 days (2.0% vs 1.9%, P = .84) or 1 year (3.2% vs 3.5%, P = .80).
Rates of death or stroke after redo-TAVR were not significantly affected by the timing of redo-TAVR (before or after 1 year of the index TAVR) or by index transcatheter valve type (balloon-expandable or non-balloon-expandable).
Redo-TAVR reduced aortic valve gradients at 1 year, although they were higher in the redo-TAVR group compared with the native-TAVR group (15 vs 12 mm Hg, P < .0001).
Rates of moderate or severe aortic regurgitation were similar between redo-TAVR and native-TAVR groups at 1 year (1.8% vs 3.3%, P = .18). Redo TAVR was associated with a significant improvement in NYHA functional class and quality of life.
A "Good Start," but More Data Needed
These findings suggest that redo-TAVR with balloon-expandable valves "might be a reasonable treatment for failed TAVR in selected patients," the investigators conclude in their article.
"The recommendation to treat and perform redo TAVR procedure is best done by a multidisciplinary team comprising interventional cardiologists, cardiac surgeons, and imaging specialists," Makkar told theheart.org | Medscape Cardiology.
Makkar also cautioned, "While this is a good start, we need additional studies with long-term clinical echocardiographic follow-up to define the role of redo TAVR procedure in the lifetime management of patients with aortic stenosis."
The authors of a comment in The Lancet say this real-world analysis "corroborates redo-TAVR as the preferred treatment strategy for transcatheter valve failure."
However, Sarah Verhemel, MD, and Nicolas Van Mieghem, MD, PhD, Department of Cardiology, Erasmus University Medical Center, Rotterdam, the Netherlands, say many questions remain, that there was selection bias in the analysis, and that redo-TAVR was only performed with a short-stented balloon-expandable valve.
"Redo-TAVR requires careful anatomical evaluation by CT to avoid prosthesis-patient mismatch, preserve coronary accessibility, and preclude coronary obstruction. As such, selected anatomical substrates might still favor surgical explant over redo-TAVR, and this important aspect was not addressed," in this study, Verhemel and Van Mieghem add.
Reached for comment, Gilbert Tang, MD, MBA, surgical director of the structural heart program at Mount Sinai Health System and associate professor of cardiovascular surgery, Icahn School of Medicine at Mount Sinai, noted that the number of redo-TAVR procedures currently is "very small, about 0.5%" of the overall TAVR procedures performed done in the US.
Going forward, "we will see more patients with TAVR failure just because they outlived the valve, and we need to understand this topic more," Tang told theheart.org | Medscape Cardiology.
"This paper contributes to the literature by showing that redo-TAVR can be done safely, but we need longer follow-up of these patients," said Tang.
He noted that among a small percentage of patients who undergo repeat TAVR (0.9%), the valve fails within a year and that the mechanism of failure is not known from the registry data.
"This was a highly select group of patients undergoing redo-TAVR. Not everyone has the anatomy that can be feasible. However, consistent with the other studies, these patients do quite well," Tang added.
The study was supported by Edwards LifeSciences. Makkar is a consultant for and has received research grants from Edwards Lifesciences, Abbott, Medtronic, and Boston Scientific. Van Mieghem has received research grant support from Edwards Lifesciences and other companies. Verhemel has disclosed no relevant financial relationships. Tang is a physician proctor, consultant, and advisory board member for Medtronic, a consultant and advisory board member for Abbott Structural Heart, an advisory board member for Boston Scientific and JenaValve, a consultant for NeoChord, and has received Speakers Honoraria from Siemens Healthineers.
Lancet. Published online August 31, 2023. Abstract, Comment
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