Risk-adjusted 30-day mortality after TAVR increased modestly from January 2019 to March 2022 in the U.S., according to an observational cohort study published in JAMA Cardiology. Exploratory analyses were unable to find any site-related, patient-related or process-related factors that explain these findings.

Suzanne V. Arnold, MD, MHA, et al., included 210,495 patients (median age 79 years; 43.4% women; median STS predicted risk of mortality 3.3%) with severe aortic stenosis who underwent TAVR between Jan. 1, 2019 and March 31, 2022, captured by the STS/ACC TVT Registry. The primary outcome was 30-day mortality.

There was no significant change in 30-day mortality during the study period (2.4% and 2.2%, respectively; p for trend = 0.10), with the unadjusted odds ratio (OR) for time being 0.98 per year (95% CI, 0.94-1.01). However, after adjusting for both patient and procedural characteristics, the OR increased to 1.09 per year (95% CI, 1.05-1.13).

Additional exploratory analyses found no meaningful changes in the adjusted odds of death after excluding the following: sites that entered the registry in 2019 or later (OR, 1.09; 95% CI, 1.05-1.13), low-volume sites (OR, 1.09; 95% CI, 1.06-1.13), low-risk patients (OR, 1.09; 95% CI, 1.07-1.15), patients with a bicuspid aortic valve (OR, 1.09; 95% CI, 1.05-1.13), in-hospital deaths (OR, 1.08; 95% CI, 1.03-1.14), and patients who experienced a major vascular complication (OR, 1.09; 95% CI, 1.05-1.12).

The authors propose other potential explanations for this increase, including “the impact of the COVID-19 pandemic and secular changes in coding of comorbidities.”

“In the absence of a clear mechanism, it is also possible that this study’s findings represent natural variation of outcomes of a therapy that is performing near the threshold of what is actually achievable – a mechanism that would only be apparent in the setting of very low event rates,” write the authors. “Given the small absolute changes in mortality, we believe that these findings should not be alarming but still require close surveillance going forward.”

Clinical Topics: Cardiac Surgery, Invasive Cardiovascular Angiography and Intervention

Keywords: National Cardiovascular Data Registries, STS/ACC TVT Registry, Transcatheter Aortic Valve Replacement