Thirty-day outcomes in patients at intermediate risk for surgery from the SAPIEN 3 European approval trial.
OBJECTIVE
This study sought to investigate outcomes of transcatheter aortic valve implantation (TAVI) with the SAPIEN 3 transcatheter heart valve (THV) in patients at intermediate risk for surgery. The 30-day results of the transfemoral cohort are reported.


RESULTS
The SAPIEN 3 European approval trial intermediate-risk cohort included a total of 101 patients with severe, symptomatic aortic stenosis, at intermediate risk for surgery suitable for TAVI via the transfemoral route (TF). Outcomes were adjudicated by a clinical events committee. Echocardiography, computed tomography and electrocardiography exams were analysed in core laboratories. The mean STS-PROM score and logistic EuroSCORE of the study population were 5.2±1.7 and 13.2±3.8, respectively. A completely percutaneous procedure was performed in 90.1% of patients and conscious sedation and/or local anaesthesia was utilised in 54.5%. Technical success was achieved in 98.0% of patients. At 30 days, mortality was 1.0%, with stroke in 3.0% and a new permanent pacemaker in 4.0% (4.3% of patients without pre-procedural permanent pacemaker). No patients had severe aortic regurgitation after the procedure, only one patient had moderate aortic regurgitation, and 70.8% of patients had no or trace aortic regurgitation.


CONCLUSIONS
TF-TAVI using the SAPIEN 3 THV in patients at intermediate risk for surgery is associated with a very low risk of death and complications, including new pacemakers and paravalvular leaks. Although compelling, these initial results are being confirmed in larger global studies before expanding the indications for TAVI in severe aortic stenosis.
Bichat Claude Bernard Hospital-Paris VII University, Paris, France.
Alec
A
Vahanian
Marina
M
Urena
Thomas
T
Walther
Hendrik
H
Treede
Olaf
O
Wendler
Thierry
T
Lefèvre
Mark S
MS
Spence
Simon
S
Redwood
Philipp
P
Kahlert
Josep
J
Rodes-Cabau
Jonathon
J
Leipsic
John
J
Webb
D000368:Aged; D000369:Aged, 80 and over; D001021:Aortic Valve / Q000601:surgery; D001022:Aortic Valve Insufficiency / Q000453:epidemiology*; D001024:Aortic Valve Stenosis / Q000601:surgery*; D005260:Female; D006350:Heart Valve Prosthesis / Q000009:adverse effects; D019918:Heart Valve Prosthesis Implantation / Q000379:methods; D006801:Humans; D008297:Male; D011183:Postoperative Complications / Q000453:epidemiology*; D012042:Registries; D012306:Risk; D065467:Transcatheter Aortic Valve Replacement / Q000379:methods; D016896:Treatment Outcome