Late Post-TAVR Mortality Mostly Noncardiac in French Registry

Pam Harrison

October 17, 2016

BREST, FRANCE — For patients with severe, symptomatic aortic stenosis in a large French registry, mortality 3 years after transcatheter aortic-valve replacement (TAVR) was high at 42%, but most of the deaths were noncardiac, and there was little evidence that the prosthetic valves deteriorated over time[1].

As published October 3, 2016 in the Journal of the American College of Cardiology, the French Aortic National CoreValve and Edwards Registry (FRANCE-2) prospectively included all TAVRs done in France between 2010 and 2012 in 34 centers. The population of 4201 high-risk patients received either the self-expandable CoreValve (Medtronic) or the balloon-expandable Sapien valve (Edwards Lifesciences).

"The vast majority of patients were followed up by echocardiography, so we have very robust data, and we showed that there is no significant deterioration of the valve over 3 years. So this gives us important information," lead author Dr Martine Gilard (Brest University Hospital, France) told heartwire from Medscape. "No patients required reoperation or reintervention due to structural valve failure."

The transfemoral approach was used in 72.9% of the cohort, the transapical approach in 17.5%, and subclavian in 5.8% of the group. As judged by a lowered mean gradient, 97% of the procedures were successful. Improvements in mean aortic gradient and valve area were sustained for up to 3 years, regardless of the approach or type of valve.

The "vast majority" of events occurred within a month of patients undergoing the procedure, and major bleeding was seen in fewer than 2% of patients at both 1 month and 1 year post-TAVR.

All-Cause and CV Mortality after TAVR in High-Risk Patients in the FRANCE-2 Registry

Follow-up time (y) All-cause mortality (%) Cardiovascular mortality (%)
1 23.2 12.2
2 32.9 15.3
3 42 17.5

As Gilard told heartwire , every registry and every trial have consistently found that the transapical approach is more likely than the transfemoral approach to lead to complications and poses a higher mortality risk. "This is because these patients are higher risk than others, but the transapical approach also creates more complications, so it's both the approach itself as well as the patients we use it in."

On multivariate analysis, eight factors predicted all-cause mortality at 3 years in the overall cohort, including male sex, low body-mass index, atrial fibrillation, need for dialysis, NYHA 3 or 4 heart failure, higher EuroSCORE, transapical or subclavian approaches, need for permanent pacing, and periprosthetic aortic regurgitation (AR) grade 2 and higher.

"The fact that age was not associated with survival in this large cohort supports the attitude of not refusing surgery for aortic stenosis on the sole grounds of age," the group writes.

Limited TAVR Survival Gains in the Very Elderly

"While it is unclear why FRANCE 2 had a lower cardiovascular mortality, there is broad agreement that even after successful TAVR, the majority of patients will have died by 5 years," observes Dr John Carroll (University of Colorado School of Medicine, Aurora) in an accompanying editorial[2]. This was again demonstrated by the "sobering" mortality rate of 42% seen in this registry cohort at 3 years.

Also, Carroll also points out the average life expectancy for an 80-year-old patient, in whom most cases of aortic stenosis occur, is about 4.6 years; the mean age of patients in the registry was about 83. "The absolute number of years of survival gained by TAVR is thus limited when applied to an elderly population."

Gilard counters that it is not age per se that increases mortality with TAVR, but rather the frailty of many of these elderly patients and the presence of comorbidities. "If you don't perform TAVR in this population, mortality is very high, at around 50% at one year, so you have to treat them," she said.

The FRANCE-2 registry is supported by Edwards Lifesciences and Medtronic. Gilard reports no relevant relationships; disclosures for the coauthors are listed in the article. Carroll reports being a site investigator for PARTNER 2 (backed by Edwards LifeSciences), SALUS (supported by Direct Flow), and Low-Risk TAVR vs SAVR (funded by Medtronic).

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