Patients undergoing surgical aortic-valve replacement (SAVR) following problems with an initial transcatheter aortic-valve replacement (TAVR) appear to have particularly poor outcomes, according to a retrospective analysis.
As Dr. Oliver K. Jawitz told Reuters Health by email, “SAVR after early failure of TAVR devices appears to be a complex, technically demanding procedure associated with long operative times, increased perioperative morbidity, and higher than expected operative mortality.”
In a paper in JACC: Cardiovascular Interventions, Dr. Jawitz of Duke University School of Medicine, in Durham, North Carolina, and colleagues observe that as TAVR grows more popular, management of device failure will become increasingly important. “However,” they say, “the outcomes of re-operation for TAVR failure are unknown.”
Out of about 40,000 TAVR procedures in the Society of Thoracic Surgeons Adult Cardiac Surgery Database, the researchers identified 123 patients with a history of prior TAVR who underwent SAVR between 2011 and 2015.
“This dataset,” they write, “is a unique mix of patients who were considered either intermediate or high-risk at the time of the initial TAVR procedure, but still low enough risk that they were candidates for a SAVR at the time of TAVR failure.”
Paravalvular leak, failed repair and structural prosthetic deterioration were among the most common reasons for surgical re-intervention. Median time to re-operation was 2.5 months.
To examine how patients fared after SAVR, the researchers compared the Society of Thoracic Surgeons predicted mortality rate (PROM) with actual mortality. Seventeen percent of patients had a PROM of less than 4%, 24% had one of 4% to 8% and 59% had a higher PROM.
The operative mortality rate was 17%, “higher than would be expected in a similar population of patients undergoing repeat SAVR,” the researchers write. For all levels of preoperative risk, the observed mortality was higher than what would have been expected.
“Further research is needed to define the role of SAVR versus valve-in-valve TAVR as well as refine operative techniques for explanting failed TAVR devices, especially as the population of patients undergoing TAVR become younger, healthier, and structural valve deterioration becomes more common,” Dr. Jawitz concluded.
Dr. Michael J. Reardon of Houston Methodist Hospital, in Texas, co-author of an accompanying editorial, told Reuters Health by email, “This study suggests that a TAVR first followed by a surgical valve may be risky.”
“Young patients who choose a biologic valve AVR to treat severe aortic stenosis will likely require more than one valve in their lifetime,” he said. “Do they choose surgical AVR and then surgical redo AVR if the valve fails?”
These techniques “are well worked out but involve two open-heart surgeries,” he added.
Dr. Reardon points out in his editorial that the possible need in younger patients for multiple valves in their lifetime “has led some to suggest the strategy of TAVR for the initial aortic valve replacement. If and when the first TAVR valve fails, the patient is still a reasonable candidate for a first time SAVR. If this SAVR fails when the patient is much older, then a TAVR in SAVR might be considered.”
However, “This strategy hinges on the presumption that the first time SAVR after a TAVR will be of no more risk than a first time SAVR alone. The answer to that assumption is unknown.”
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