No difference was found in one-year rates of death, stroke and days alive out of hospital (DAOH) between patients who underwent transcatheter aortic valve replacement (TAVR) and those who had surgical aortic valve replacement (SAVR), according to a nationally representative real-world cohort study published July 17 in the Journal of the American College of Cardiology.

J. Matthew Brennan, MD, et al., used data from the STS/ACC TVT Registry, a partnership of the ACC and The Society of Thoracic Surgeons, and the STS National Database. By linking this data to Medicare administrative claims, they analyzed 9,464 patients with severe aortic stenosis, half of whom underwent TAVR, half who had SAVR. Patients were primarily elderly (median age, 82 years) and had a median STS predicted risk of mortality of 5.6 percent.

While researchers discovered no difference in one-year rates of death (17.3 percent vs. 17.9 percent), stroke (4.2 percent vs. 3.3 percent) or DAOH (hazard ratio 1.00), they discovered differences in procedure outcomes. During the index admission, TAVR patients averaged 31 hours in the intensive care unit (ICU) and 4 days in the hospital, while SAVR patients averaged 68 hours in the ICU and 8 days in the hospital. TAVR patients were also more likely than SAVR patients to be discharged to their home (69.9 percent vs. 41.2 percent) vs. an extended care facility, transitional care unity or rehabilitation unit (20.5 percent vs. 41.2 percent, p < 0.01).

"The results of our analyses are largely consistent with those of the pivotal randomized clinical trials," write the study authors. "In our study, we used detailed phenotypic information […] to both exclude patients who would not have been considered for both procedures and closely match the remaining eligible patients […] The availability of these additional data elements may account for differences between our study outcomes and both the GARY and SAPIEN 3 results, allowing for a more accurate approximation of the existing randomized trial results."

In a related editorial comment, A. Pieter Kappetein, MD, PhD, and Alec S. Vahanian, MD, PhD, comment that "this study provides a unique insight into whether the results of randomized-controlled trials are comparable to the results of routine clinical practice."

It also "contains interesting data about the daily practice of TAVR and SAVR and further confirms the potential expanding role of TAVR in the population of elderly patients with severe aortic stenosis. In the future, executing randomised clinical trials using registries, as is done in Sweden, would be desirable," they add.

Keywords: United States, Aged, 80 and over, Aortic Valve, Transcatheter Aortic Valve Replacement, Cohort Studies, Skilled Nursing Facilities, Sweden, Aortic Valve Stenosis, Heart Valve Prosthesis, Registries, Patient Discharge, Medicare, Intensive Care Units, Stroke, Surgeons

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