Patients with chronic kidney disease (CKD) and severe aortic stenosis (AS) face similar long-term outcomes after transcatheter aortic valve replacement (TAVR) with a third-generation valve and surgical aortic valve replacement (SAVR), according to new findings published in JACC: Cardiovascular Interventions.
“The choice of intervention in patients with CKD and AS is complex and influenced by multiple competing factors, including reduced life expectancy, increased risk for bleeding, further deterioration of renal function after aortic valve replacement, and feasibility of valve-in-valve procedures to treat bioprosthetic structural valve deterioration (SVD), which is thought to be increased in patients with CKD,” wrote lead author Santiago Garcia, MD, a cardiologist at the Minneapolis Heart Institute, and colleagues. “There is no specific recommendation in societal guidelines regarding choice of intervention between SAVR and transcatheter TAVR in patients with CKD.”
Garcia et al. explored data from the Partner 2A clinical trial and PARTNER 2 SAPIEN 3 Intermediate Risk Registry, which were both originally sponsored by Edwards Lifesciences. The group focused on a subset of more than 1,500 patients diagnosed with severe or moderate CKD. More than 1,000 of those patients underwent TAVR—533 received the third-generation Sapien 3 valve, 512 received the second-generation Sapien XT valve—and nearly 500 patients underwent SAVR.
The study’s primary endpoint was a composite of mortality, stroke, rehospitalization and new hemodialysis. Overall, after five years, that endpoint was seen in 52.8% of SAVR patients, 68% of patients with the Sapien XT valve and 58.7% of patients with the Sapien 3 valve.
Perioperative acute kidney injury was seen in 26.3% of SAVR patients and 10.3% of TAVR patients. In addition, surgical valves and the Sapien 3 valve had similar durability after five years.
Also, TAVR and SAVR “were associated with a similar risk for progression to hemodialysis.”
“Taken together, our study findings of equipoise for hard clinical endpoints between Sapien 3 TAVR and SAVR in patients with severe AS and CKD at intermediate surgical risk suggest that the choice of intervention should be individualized by the heart team after careful considerations of clinical and anatomical variables detected on TAVR computed tomography angiography, along with patient preference,” the authors wrote.
The team did emphasize the fact that follow-up was limited to five years, “a period that may not be sufficient to observe differences in SVD and bioprosthetic valve failure rates between surgical and transcatheter valves.” Also, one of the devices they focused on—the Sapien XT valve—is no longer commercially available in the United States.
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