"Our study and other smaller studies suggest there could be improvement in neurocognitive function after TAVR in some patients with abnormal baseline cognition," Dr. Srinivasa Potluri of Baylor Scott and White The Heart Hospital-Plano in Texas told Reuters Health by email. "Therefore, patients with lower MMSE (dementia) at baseline could be considered for TAVR after heart-team discussion weighing benefits and risks."
That said, he added, "Our findings are hypothesis-generating and need to be confirmed in larger studies."
The team's post hoc analysis of the multicenter PARTNER 3 trial (https://bit.ly/32Y6VB4) involved 1,000 low-risk patients with severe aortic stenosis randomly assigned to TAVR or SAVR.
The mean baseline MMSE score was 28.6 on a scale of 1 to 30, with scores of 20 to 24 suggesting mild dementia, 13 to 20 suggesting moderate dementia, and lower scores indicating severe dementia.
As reported in JACC: Cardiovascular Interventions, 165 of 926 patients (17.8%) had MMSE scores of 27 or less. Overall, there was minimal improvement in MMSE from baseline to 30 days and no improvement at one year with either procedure.
An analysis of the patients with baseline MMSE scores of 27 or less showed significant improvement in MMSE at 30 days (2.4 points; 150 participants) and at one year (2.2; 144 participants). While scores improved with both treatments, a greater relative improvement was seen with TAVR versus SAVR (2.7 versus 1.5).
Dr. Potluri said, "We will continue to collect neurocognitive information for patients who undergo TAVR. The current study is a one-year followup and and these patients will continue to be followed. We are also part of the PROTECTED TAVR trial, (https://bit.ly/36VjFtD) which randomizes patients to embolic protection (to possibly prevent strokes) versus no embolic protection during TAVR. We will be comparing neurocognitive function in those patients."
Dr. Ibrahim Sultan, Director, UPMC Center for Thoracic Aortic Disease and Surgical Director, UPMC Center for Transcatheter Aortic Valve Therapies in Pennsylvania, commented by email to Reuters Health, "These were low-risk patients and the majority (had) normal or very near normal preoperative cognitive exams, so it would be rather challenging to detect any clinically significant differences."
"One should be careful in interpreting results that arise from post-hoc analyses in relatively small numbers of patients, as the trial was not designed to address this specific question," he noted. "I think the most important message here is that severe symptomatic aortic stenosis should be a strong consideration for treatment with TAVR or SAVR."
"As cognition improved with either therapy, if there are other compelling reasons for SAVR, such as concomitant valve and coronary disease, aortic aneurysm, atrial fibrillation etc., one should not be deterred from offering SAVR on the basis of cognition alone," he said.
Dr. Eugene Golts, a cardiothoracic surgeon at UC San Diego Health, also noted the small number of patients and retrospective nature of the study. "It is, however, important to study the issue further and on a broader scale," he told Reuters Health by email. "I would focus on the entire cohort of patients undergoing SAVR and TAVR, rather than focusing on the ones with the lower MMSE. In general, MMSE has not been seen as the sensitive indicator of mental performance."
"I think that decision making regarding the choice of TAVR versus SAVR for low-risk patients should be guided by the long-term durability of the valves," he concluded.
The study was funded by Edwards Lifesciences. Dr. Potluri and two coauthors have received fees from the company and one coauthor is an employee.
By Marilynn Larkin
SOURCE: https://bit.ly/2KhdB6Q JACC: Cardiovascular Interventions, online November 16, 2020.
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