SAVR an Option for Many Low-Risk Patients Excluded From Clinical Trials

By David Douglas

January 20, 2021

NEW YORK (Reuters Health) - Many patients who are excluded from clinical trials comparing transcatheter aortic-valve replacement (TAVR) with surgical aortic-valve replacement (SAVR) appear to do well with the latter approach, according to researchers in Canada.

"In real-world clinical practice, about one-half of low-risk patients with severe aortic stenosis undergoing SAVR have at least one characteristic prompting exclusion from randomized comparisons to TAVR," Dr. Josep Rodes-Cabau of Laval University, in Quebec City, told Reuters Health by email.

"In these cases, SAVR was associated with similar outcomes to the rest of the low-risk SAVR recipients, and the observed mortality was even lower than that estimated by surgical risk scores, with the exception of those patients with concomitant mitral/tricuspid valve disease, who exhibited an increased risk," he said.

Dr. Rodes-Cabau and colleagues examined data on more than 6,700 patients with severe aortic stenosis (SAS) who underwent SAVR at their institution between 2000 and 2019.

More than three-quarters were at low surgical risk, and of this group 41% had at least one condition that would have led to trial exclusion. These included non-tricuspid aortic valve (NTAV), severe coronary-artery disease (SevCAD), as well as those requiring concomitant mitral/tricuspid valve (CMTV) or concomitant ascending-aorta replacement (CAAR).

In the low-risk patients overall, at 30 days mortality was 1.9% and the stroke rate was 2.4%. Compared with the rest of the cohort, the mortality rate was similar in the SevCAD (2.6%) and CAAR (2.1%) groups. It was lower in the NTAV group (0.9%) and higher in the CMTV group (5.9%).

As the authors write in the Journal of the American College of Cardiology, "Clinical outcomes were better than or similar to those predicted by surgical scores in all groups but those patients requiring CMTV intervention."

These results, concluded Dr. Rodes-Cabau, "should be considered in the expansion of TAVR toward the treatment of low-risk patients and may inform future randomized trials in the field."

Dr. Poonam Velagapudi, co-author of an accompanying editorial, told Reuters Health by email, "TAVR has become an important part of the treatment algorithm in patients with severe aortic stenosis including those at low surgical risk. However, there are important clinical criteria . . . that have been excluded from TAVR versus SAVR trials."

In this study, added Dr, Velagapudi, of the University of Nebraska Medical Center, in Omaha, "the prevalence of these clinical criteria was about 40% and surgical mortality was lower than that calculated by the Society of Thoracic Surgeons scores in all groups . . . except in the CMTV group."

"In the absence of randomized clinical trial data," he concluded, "the treatment strategy in these special groups is not black and white but rather requires careful assessment by the heart team taking into account several patient and anatomical criteria including age, comorbidities, aortic valve morphology and femoral anatomy."

SOURCE: https://bit.ly/3oURm6o and https://bit.ly/3nSmbHb Journal of the American College of Cardiology, online January 19, 2021.

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