Cardiologist highlights safety, effectiveness of Boston Scientific TAVR valve
An updated study of data from the Swedish national heart registry (SWEDEHEART) found no significant difference in outcomes between Boston Scientific's Acurate Neo2 transcatheter aortic valve replacement (TAVR) device and its widely used counterparts, the Sapien 3 platform from Edwards Lifesciences and Evolut platform from Medtronic. The study challenges findings from a recent U.S. pivotal trial that cast doubt on the Acurate Neo2's performance.
An analysis of the Acurate Neo2 U.S. Find and Drug Administration (FDA) investigational device exemption (IDE) trial found U.S. operators who were not used to working with the valve did not know to check imaging in the cath lab to ensure full expansion of the valve frame, and to balloon dilate the valve to ensure full expansion if needed. If U.S. operators had known what to look for and had performed the additional ballon for, clinicians believe it is likely the trial would have turned out positive for valve, rather than showing inferiority due to poorer patient outcomes.
The new review of SWEDEHEART data comparing patients treated with the Acurate Neo2, Evolute and Sapien found no significant differences in outcomes. The data were presented by as a late-breaking trial at the Cardiovascular Research Technologies (CRT) 2025 meeting in March by Andreas Ruck, MD, PhD, head of the Transcatheter Aortic Valve Implantation (TAVI) program at Karolinska University Hospital in Stockholm, Sweden, and the chairman of the Swedish Percutaneous Valve Registry, part of SWEDEHEART.
“In Sweden, when we use these valves, we post-dilatate much more than the U.S. and also with bigger balloons," Ruck explained. "So the basic message is that you need to do a proper pre- and a proper post-dilatation in about 50% of the patients, which is actually quite simple to do. Our data show that if you use the Acurate together with the rigorous pre- and post-dilatation strategy, it's safe to use and has good outcomes."
The SWEDHEART data included nearly 2,000 Swedish patients and matched the U.S. IDE trial in design and follow-up parameters. While the U.S. data initially indicated the Acurate Neo2 underperformed compared to the Sapien and Evolut valves, Ruck’s team found no excess risk for stroke or other key adverse endpoints.
“The U.S. investigators were following protocol, but lacked the experience or awareness to recognize when the valve needed further expansion,” Ruck said. “Now that we know what to look for, the performance gap essentially disappears.”
Importantly, the Swedish data also found no added risk associated with post-dilatation, with zero incidences of major complications like tamponade or stroke among the nearly 300 patients who underwent the procedure.
Dave Fornell has covered healthcare for more than 17 years, with a focus in cardiology and radiology. Fornell is a 5-time winner of a Jesse H. Neal Award, the most prestigious editorial honors in the field of specialized journalism. The wins included best technical content, best use of social media and best COVID-19 coverage. Fornell was also a three-time Neal finalist for best range of work by a single author. He produces more than 100 editorial videos each year, most of them interviews with key opinion leaders in medicine. He also writes technical articles, covers key trends, conducts video hospital site visits, and is very involved with social media. E-mail: [email protected]