As Dr. Tsuyoshi Kaneko of Brigham and Women's Hospital, in Boston, told Reuters Health by email, "the incidence of TAVR explant was low, but the mortality was high. It remains to be seen whether surgeon experience and lower patient risk profile will lower the mortality in the future, and its implications on lifetime management of aortic stenosis with TAVR and surgical aortic-valve replacement (SAVR)."
As TAVR expands to younger patients, valve reintervention is inevitable in the setting of possible structural valve deterioration, endocarditis, or significant paravalvular leakage, Dr. Kaneko and colleagues note in the Journal of the American College of Cardiology.
For most patients who require valve reintervention after their initial TAVR, TAVR-in-TAVR may be an option, they add, but a subset of patients may need surgical explantation.
Little is known about the outcomes of this. To investigate, the researchers studied data on more than 132,000 patients who underwent TAVR between 2012 and 2017. The incidence of surgical explant was 0.28% in the early TAVR era before 2015, when first-generation TAVR valves were used, and 0.14% thereafter.
The median time to surgical explant was 212 days. Bioprosthesis failure (in 79.3%) was the main reason for reintervention.
The mortality rate was 13.2% at 30 days and 22.9% at one year. These rates did not vary by either time to surgical explant or TAVR era, or between patients with or without endocarditis.
With a mean age of 73.7 years, patients who underwent explantation were significantly younger than those who did not (81.7 years). They had a lower prevalence of heart failure (55.9% vs. 65.8%) and were more likely to have a lower-risk profile (15.0% vs. 2.4%).
Compared with patients who didn't undergo explantation, the hazard ratio for mortality was 4.03, a significant risk increase. The time to surgery and the year conducted were not associated with worse post-explantation survival.
The researchers call for longer follow-up in more patients "to clarify the implications of these observations for patients with aortic stenosis whose life expectancy exceeds the anticipated durability of valve prostheses after TAVR."
In an accompanying editorial, Dr. Oliver K. Jawitz of Duke University Medical Center, in Durham, North Carolina, agrees, pointing out that "Future studies including younger, low-risk TAVR patients as well as those experiencing structural valvular degeneration many years later will be incredibly important to enhancing our understanding of how to best care for this rapidly growing population of patients."
He told Reuters Health by email that the current study "is an important contribution to the growing body of literature describing outcomes of patients undergoing SAVR after TAVR. The longitudinal follow-up documented in the Medicare database further supports previous findings that SAVR after failure of TAVR is associated with significant morbidity and mortality and we have much to learn regarding how to best care for and risk stratify patients with failed TAVR prostheses.
By David Douglas
SOURCE: https://bit.ly/2ItXGkG and https://bit.ly/3nRvh8B Journal of the American College of Cardiology, online October 12, 2020.
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