SAVR outperforms TAVR in patients with bicuspid aortic valves
Surgical aortic valve replacement (SAVR) is associated with better long-term outcomes than transcatheter aortic valve replacement (TAVR) when treating patients with bicuspid aortic valves, according to new data published in The Annals of Thoracic Surgery.[1]
The study’s authors noted that patients with bicuspid aortic valves are often excluded from TAVR trials, making the procedure’s impact on this specific population unclear. Because TAVR is being used more and more to treat severe symptomatic aortic stenosis, the group turned to U.S. Centers for Medicare and Medicaid Services (CMS) data in hopes of learning more about this topic.
“The purpose of the current analysis was to evaluate real-world contemporary longitudinal outcomes of TAVR vs. SAVR in Medicare beneficiaries with bicuspid aortic valve stenosis,” wrote first author James Hunter Mehaffey, MD, MSc, a cardiac surgeon and assistant professor with the West Virginia School of Medicine’s department of cardiovascular and thoracic surgery, and colleagues. “We hypothesized that SAVR would be associated with higher early morbidity and mortality, but it had superior longitudinal freedom from death, stroke or valve reintervention over the study period.”
Mehaffey et al. explored CMS data from more than 11,000 patients with bicuspid aortic valves who underwent aortic valve replacement from 2018 to 2022. While more than 8,000 of those patients were treated with SAVR, more than 3,000 were treated with TAVR. The median age was 70 years old, 64.5% of patients were men and the median follow-up periods were 2.6 years for the SAVR group and 2.4 years for the TAVR group.
Following treatment, TAVR was linked to a significantly lower rate of acute kidney injury (AKI) (6.2% vs. 15%), but a significantly higher risk of new permanent pacemaker implantation (12.4% vs. 2.3%). SAVR patients had longer hospitals stays, as one may expect due to the minimally invasive nature of TAVR, but median healthcare costs were still significantly lower after surgery ($34,425 vs. $39,168). Also, index mortality was higher after SAVR (1.3% vs. 0.5%), but the combined outcome of index mortality and 30-day mortality was similar for the two treatment options.
Over the course of the study, meanwhile, the readmission rate was higher after TAVR (33.2%) than after SAVR (31.1%), primarily due to significantly higher readmission rates for stroke (2.8% vs. 1.7%) and heart failure symptoms (17.6% vs. 12%).
The authors then performed a separate analysis that accounted for certain risk factors, including age and presenting with certain comorbidities. The composite outcome of death, stroke or valve intervention following treatment was more common after TAVR (14.3%) than SAVR (7.9%).
Finally, the group performed one more analysis that focused exclusively on low-risk patients younger than the age of 75. This included more than 5,000 SAVR patients and more than 1,500 TAVR patients. After adjusting for certain risk factors, TAVR was once again associated with a lower risk of AKI than SAVR, but higher risk of a permanent pacemaker. In addition, the longitudinal risk of mortality, stroke or valve reintervention was significantly higher for TAVR (6.4%) than SAVR (4.7%).
Reviewing these findings, the authors highlighted TAVR’s consistently higher stroke rate.
“Patients with bicuspid aortic valve stenosis are known to commonly have higher calcium burden, often involving the left ventricular outflow tract,” the group wrote. “The potential of increased periprocedural stroke in heavily calcified bicuspid aortic valves poses a unique challenge and potential risk in this population. The present study of over 7,000 bicuspid aortic valve only patients suggest a higher risk of stroke associated with TAVR, not only peri-operatively, but also cumulatively through the five years following the procedure.”
This research did have certain limitations, the researchers wrote. These include the “administrative nature of the CMS database,” for example, and the fact that these findings may not necessarily represent the impact of treatment in patients younger than 65 years old. Even with these things in mind, however, Mehaffey and colleagues believe their research adds additional depth to the ongoing conversation comparing aortic valve replacement treatment strategies with one another.
“These contemporary data may further inform heart team decision-making and future clinical trial design in patients with bicuspid aortic valves,” the authors concluded.
Click here to read the full study in The Annals of Thoracic Surgery, a journal from The Society of Thoracic Surgeons.