Performing transcatheter aortic valve replacement (TAVR) with a balloon-expandable valve (BEV) is associated with better clinical outcomes than using a self-expanding valve (SEV), according to new findings published in the American Journal of Cardiology.[1] The study’s authors aimed to deliver a new perspective on this topic by focusing on an Asian patient population as opposed to Western patients.
“The specific choice between BEV or SEV depends on the anatomy of a patient's aortic root or access route,” wrote first author Young Kyoung Sa, MD, PhD, with the cardiology division at Yeouido St. Mary’s Hospital in Seoul, South Korea, and colleagues. “However, the rationale for device choice is not yet firmly established and, it remains arbitrary to the operator's decision, even while using newer-generation valves. It is essential to compare clinical outcomes of each new-generation TAVR valve.”
The team tracked data from nearly 1,200 TAVR patients who received treatment from March 2016 to December 2018. Second-generation TAVR valves implanted over the course of this analysis included the Evolut R valve from Medtronic, the Sapien 3 valve from Edward Lifesciences and the Lotus Edge valve from Boston Scientific.
All patients were over the age of 65 years old. Data came from South Korea’s National Health Insurance Service program, which covers 98% of the country’s population.
While 60.3% of patients were treated with a BEV, the remaining 38.6% were treated with an SEV. The mean age was nearly the same for BEV patients (79.8 years old) and SEV patients (80 years old), and 57.1% of patients were female in both groups. In addition, patient comorbidities were not statistically different between the two groups.
Overall, after a mean follow-up period of 13.1 months, BEV TAVR was linked to lower all-cause mortality (9.7%) than SEV TAVR (14.4%). Permanent pacemaker implantation (PPI) was also much less common among BEV TAVR patients than SEV TAVR patients (5.8% vs. 14.2%). The risks of ischemic stroke and intracranial hemorrhage were not statistically significant between the two patient groups.
When looking only at 30-day outcomes, the authors added, the all-cause mortality rate was no longer statistically significant. The PPI rate was still higher, however, as clinicians typically know rather quickly when a pacemaker may be required.
“Although there might be limitations to generalizing these results, this study provides some unique information,” the authors wrote. “The present study solely included newer-generation valves and analyzed mid-term clinical outcomes. Until now, there have been a few reports comparing BEV and SEV. However, most of them were meta-analyses based on extrapolation of landmark trials comparing TAVR versus surgical aortic valve replacement or short-term results or analysis from old-generation valves.”
The researchers also noted that their study provides clinicians with much-needed context when they treat patients from Asian countries.
“In Asian patients, studies comparing each device type of TAVR have been extremely rare,” they wrote. “Even in large-scale randomized trials used as the basis for TAVR, very few Asians were included. Given that Asians tend to have smaller body habitus which may influence TAVR outcomes, studies examining this issue are important.”
The group concluded that long-term studies exploring the clinical impact of each modern TAVR valve are still needed to help clinicians make the right decisions for their patients.
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Michael has more than 16 years of experience as a professional writer and editor. He has written at length about cardiology, radiology, artificial intelligence and other key healthcare topics.