Sapien 3: Results for High-Risk, Inoperable TAVR Patients Now in Print


Data presented last fall at TCT 2015 showing very low 1-year event rates in a registry population of TAVR patients implanted with the Sapien 3 valve have now been published.

Lead author Howard Herrmann, MD (Hospital of the University of Pennsylvania, Philadelphia), told TCTMD that while the paper—published online today ahead of print in Circulation—contains no new data, it does include an expanded multivariable analysis confirming that mild paravalvular leak, observed in 29.1% of patients at 1 year, did not have any association with mortality.

TCTMD reported on the presentation from last October that showed 85.6% overall 1-year survival among 583 high-risk or inoperable patients with severe aortic stenosis who underwent TAVR with the Sapien 3 valve (Edwards Lifesciences) at 29 US sites.

Additionally, the paper reports that independent predictors of all-cause mortality were major stroke (HR 10.33; 95% CI 4.62-233.09) and use of alternative access (HR 2.06; 95% CI 1.26-3.36). Another analysis examining outcomes from 30 days to 1 year found that moderate paravalvular leak also independently predicted all-cause mortality (HR 3.75; 95% CI 1.57-8.96).

Comparing these data with earlier PARTNER outcomes and the initial US experience with the TVT Registry, Herrmann said the mortality rates are now “about half” what they once were. “So a lot has improved over time for these high-risk and inoperable patients based on a combination of things. It’s probably not just purely the design features of Sapien 3,” he said. Increased operator knowledge and experience as well as improved patient selection have also played roles.

Looking back, Herrmann continued, “if we previously believed that in high-risk patients, for instance, that TAVR was equivalent to surgery based on PARTNER 1A, now that TAVR is half as dangerous as it used to be, [it] may be even better than surgery.

“So one could make the argument that if we thought it was an alternative to surgery in the past, maybe now we could make the argument that it really should be the preferred [procedure] for high-risk patients,” he said.

For now, the use of Sapien 3 at his institution is allowing for increased uptake of “minimalist approaches,” Herrmann reported. For example, he said, more than 90% of the TAVR patients at his hospital have transfemoral access and the same proportion also receive conscious sedation or monitored anesthesia care rather than general anesthesia with intubation.

Combined with the observational data on intermediate-risk patients presented at the 2016 American College of Cardiology Scientific Sessions in March showing superior outcomes with Sapien 3 TAVR as compared with a historical control group treated surgically, Herrmann said the evidence is mounting in favor of using TAVR in a greater number of patients. “Hopefully by the fall, we will have an [FDA] approval for intermediate-risk patients,” he said, adding that in his opinion, the positive outcomes seen in trials for high- and intermediate-risk patients “justifies moving into the low-risk population” as well. Trials exploring a role for TAVR in low-risk patients have not yet wrapped up enrollment.

 


 

 

 

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Sources
  • Herrmann H, Thourani VH, Kodali SK, et al. One-year clinical outcomes with SAPIEN 3 transcatheter aortic valve replacement in high risk and inoperable patients with severe aortic stenosis. Circulation. 2016;Epub ahead of print.

Disclosures
  • Herrmann reports receiving research grant support from Edwards Lifesciences, St. Jude Medical, Medtronic, Boston Scientific, Abbott Vascular, Gore, Siemens, Cardiokinetix, and Mitraspan; receiving consulting fees/honoraria from Edwards Lifesciences and Siemens; and holding equity in Microinterventional Devices.

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