‘Strikingly’ low 1-year mortality recorded for TAVR device
medwireNews: Findings from the PARTNER trial of the SAPIEN3 transcatheter heart valve system support the use of transcatheter aortic valve replacement (TAVR) as “the preferred therapy” in high-risk and inoperable patients with aortic stenosis.
The results showed that the low-profile balloon-expandable device was associated with a low rate of early complications, which contributed to a very low 14.4% mortality rate and a high cardiovascular survival rate of 91.9% at 1 year.
“The low mortality reported in this study is particularly striking when compared to prior studies with previous generation balloon-expandable valves”, says the team.
They believe the results reflect a combination of the new design features of SAPIEN3 (Edwards Lifesciences, Irvine, California), procedural improvements, operator experience and improved patient selection.
A total of 583 high-risk or inoperable patients, aged an average of 83 years, participated in the trial, 42% of whom were women
The patients were treated via the transfemoral access route in 84.2% of cases with alternative approaches including transapical in 10% and transaortic in 6%.
The median Society of Thoracic Surgeon (STS) score at baseline was 8.4 and this was slightly higher, at 9.1, in those treated with an alternative access approach.
In the first 30 days, moderate paravalvular leak (PVL) occurred in 2.9% of patients and there was no significant change over the remainder of the 1-year follow-up. At 1 year, 68.1% of patients had no PVL, 29.1% had mild PVL, 2.7% moderate PVL and none of the patients had severe PVL.
This low rate of moderate and severe PVL is likely due to the benefits of an external fabric seal on the device, note researcher Howard Herrmann (Hospital of the University of Pennsylvania, Philadelphia, USA) and colleagues.
Only moderate PVL was an independent predictor of all-cause mortality at 1 year, increasing the risk 3.75-fold; mild PVL had no significant effect on mortality.
Stroke was also independently associated with all-cause mortality, increasing the likelihood 10.33-fold. Rates increased between 30 days and 1 year, from 1.4% to 4.3% for all stroke and from 0.9% to 2.4% for major stroke.
This “is not surprising in this elderly population with multiple risk factors for stroke, including atrial fibrillation in more than 40% of patients”, says the team.
Otherwise, excellent valve prosthesis haemodynamics seen at 30 days were sustained at 1 year.
As a result of these good early outcomes, the patients showed marked improvements in symptoms. The percentage of patients in New York Heart Association (NYHA) class 3 or 4 decreased from 90% to 13% at 30 days and further to 8% at 1 year. And Kansas City Cardiomyopathy Questionnaire (KCCQ) scores improved from 46.9 at baseline to 72.4 at 1 year.
“These excellent 1-year follow-up data with SAPIEN3 support the use of TAVR as the preferred therapy in high-risk and inoperable patients with aortic stenosis as well as further evaluation of this device in lower risk patients”, the researchers conclude in Circulation.
By Lucy Piper
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