Sapien 3 Experience in Europe, Canada Shows Low Mortality, Paravalvular Leak at 30 Days
PARIS, France—Intermediate-risk patients with aortic stenosis in Europe and Canada had a low mortality rate at 30 days after implantation with the newest-generation Sapien 3 valve, according to results presented May 20, 2015, at EuroPCR.
Following on the heels of the US Sapien 3 findings presented earlier this year, the study “suggests that Sapien 3 [TAVR] may be expected to challenge [surgery] as the gold standard treatment in elderly patients with aortic stenosis,” said presenter Alec Vahanian, MD, of Bichat Hospital (Paris, France).
Designed with a skirt to prevent paravalvular leak, improved coaxial alignment, and more accurate positioning, Sapien 3 (Edwards LifeSciences) is different than the prior valves released by the same manufacturer.
For this study, researchers looked at 101 patients (average age 84.4 years; 54.5% women) at 13 centers in Europe and Canada. Notably, 45.5% of patients received the 23mm valve. At baseline, average STS score and logistic EuroSCORE were 5.2 and 13.2, respectively, and 64.4% of patients were in NYHA class III/IV.
Technical success was achieved in 98% of patients. More than half of procedures (54.5%) were done with the use of conscious sedation instead of general anesthesia—this figure was 17% in the US trial. Postdilatation was performed in 4%, and there were no instances of coronary obstruction, valve embolization, or annular rupture.
Adverse clinical outcomes were uncommon at 30 days, with “the lowest mortality rate ever observed” in any trial of an Edwards valve, according to Dr. Vahanian:
- All-cause mortality: 1%
- Cardiovascular mortality: 1%
- All stroke: 4%
- Major vascular complications: 2%
- Life-threatening bleeding: 2%
- Acute kidney injury: 2%
- New-onset A-fib: 6.9%
- New permanent pacemaker: 4%
There were no instances of MI, valve thrombosis, congestive heart failure, or small-vessel disease requiring a repeat procedure.
At 30 days, 90.8% of patients were classified as NYHA class I/II (P < .001 vs baseline). Effective orifice area increased as mean gradient decreased (P < .0001 for both). Moderate paravalvular leak was observed in only 2.3% of patients and there were no instances of severe regurgitation.
Is an RCT Necessary?
“If you try to put into perspective the other Sapien 3 trials which [have been presented recently], you see that all these figures are perfectly concordant and the results here are even slightly better,” Dr. Vahanian said.
Even though this study was small and not randomized, he said, the findings “sound like the best surgical results we have today in similar patients.” Still, Dr. Vahanian advocated for a randomized trial to be able to confidently say TAVR with Sapien 3 is the optimal option for this patient group.
But, “if you have patients with a median age of 84, with an STS score of 5.2, and you only have a 1% mortality [rate], why would we need a randomized study?” asked panel co-chair A. Pieter Kappetein, MD, of Erasmus University Medical Center (Rotterdam, the Netherlands).
It is all about “accumulating evidence,” Dr. Vahanian replied. “This shows very consistent data—it's further proof. We are going to get a randomized study in the very near future and then we'll have a very solid basis to write down new guidelines.”
Still, as new surgical heart valves are approved by objective performance criteria “where you have to be below a certain threshold for valve thrombosis and perivalvular leak,” Dr. Kappetein said, “would this be a better way to move forward instead of doing a new randomized study, especially when we move to lower-risk patients?”
One approach “eliminates” the other, Dr. Vahanian commented, adding that long-term follow-up is necessary either way. This study will follow patients out to 5 years. “That’s a minimum if we are to deal with younger patients in better shape,” he said.
As for now, panel chair Carlos E. Ruiz, MD, PhD, of Long Island Jewish Medical Center (New York, NY), said, “Obviously this valve has raised the bar to the level that is going to be very hard for any other valve technologies to emulate.”
Vahanian A. 30-day outcomes of intermediate-risk patients with the new-generation balloon-expandable transcatheter heart valve via the transfemoral approach. Presented at: EuroPCR; May 20, 2015; Paris, France.
Dr. Vahanian reports serving as a consultant to Edwards LifeSciences.