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Durability of newer TAVR valve comparable to that with SAVR

Journal of the American College of Cardiology
Reuters Health - 13/10/2020 - Following transcatheter aortic valve replacement (TAVR) using a 3rd generation device, structural valve deterioration (SVD) does not differ markedly from that following surgical aortic valve replacement (SAVR), according to an analysis of trial and registry data.

As Dr. Philippe Pibarot explained in an email to Reuters Health, "The mid-term, i.e. 5-year, durability of TAVR with the second generation of balloon-expandable valve: SAPIEN XT is inferior that of SAVR. However, the good news is that durability of TAVR with the 3rd generation, the SAPIEN 3, is similar to SAVR."

Dr. Pibarot of Laval University, Quebec, Canada, and colleagues studied data from the randomized PARTNER 2A trial, in which patients received either TAVR with the SAPIEN XT or SAVR. Also included were registry entries covering patients assigned to TAVR with the SAPIEN 3.

SVD-assessments and echocardiographic data on valve function were available for 774 patients who underwent SAPIEN XT TAVR, 664 who had SAVR and 891 who received SAPIEN 3 TAVR, the researchers reported in the Journal of the American College of Cardiology,

Compared with SAVR, the SAPIEN-XT TAVR cohort had significantly higher 5-year exposure-adjusted incidence rates of SVD per 100 patient-years (amounting to 1.61 versus 0.61). This was true of other measures including all-cause bioprosthetic valve failure (0.81 versus 0.27).

However, the 5-year rates of SVD and SVD-related bioprosthetic valve failure were significantly lower in SAPIEN 3 versus SAPIEN XT TAVR matched cohorts. In addition, they were not significantly different to those in a propensity score matched SAVR cohort. For example, exposure-adjusted incidence rates of SVD per 100 patient-years were 0.68 in the SAPIEN 3 group and 0.60 in those who underwent SAVR.

"These encouraging results provide further support to the use of TAVR with the SAPIEN 3 as an alternative to SAVR in the low-risk population," Dr. Pibarot said. "Longer-follow-up is need to confirm the long-term (10 years) durability of TAVR in this population."

Dr. Eric Van Belle, co-author of an accompanying editorial, told Reuters Health by email that the lower durability of SAPIEN-XT TAVR versus SAVR "provides one of the probable reasons for the higher late mortality (beyond 2 years) observed with SAPIEN-XT versus SAVR reported earlier this year."

"The present study," added Dr. Van Belle of University Hospital, Lille, France, "demonstrating a similar durability with SAPIEN-3 TAVR versus SAVR, provides an explanation for the excellent 5 years clinical outcome recently reported with SAPIEN-3 versus SAVR." And given that both TAVR with SAPIEN 3 and SAVR "have durability issues of the same order of magnitude at 5 years, the timely use of the two techniques along the patient's lifespan is crucial."

Edwards Lifesciences, who markets the transcatheter heart valves, sponsored the PARTNER 2A trial and the SAPIEN 3 study. Dr. Pibarot has relationships with the company as do a number of other authors, two of whom are employees of Edwards Lifesciences.

By David Douglas

SOURCE: https://bit.ly/36TEEP0 and https://bit.ly/2SNNsh1 Journal of the American College of Cardiology, online October 12, 2020.

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