Procedural and 30-day outcomes following transcatheter aortic valve implantation using the third generation (18 Fr) corevalve revalving system: results from the multicentre, expanded evaluation registry 1-year following CE mark approval.
OBJECTIVE
To describe the procedural performance and 30-day outcomes following implantation using the 18 Fr CoreValve Revalving System (CRS) as part of the multicentre, expanded evaluation registry, 1-year after obtaining CE mark approval.


RESULTS
Patients with symptomatic severe aortic stenosis and logistic Euroscore > or =15%, or age > or =75 years, or age > or =65 years associated with pre-defined risk factors, and for whom a physician proctor and a clinical specialist were in attendance during the implantation and who collected the clinical data, were included. From April 2007, to April 2008, 646 patients with a mean age of 81 +/- 6.6 years, mean aortic valve area 0.6 +/- 0.2 cm2, and logistic EuroSCORE of 23.1 +/- 13.8% were recruited. After valve implantation, the mean transaortic valve gradient decreased from 49.4 +/- 13.9 to 3 +/- 2 mmHg. All patients had paravalvular aortic regurgitation < or = grade 2. The rate of procedural success was 97%. The procedural mortality rate was 1.5%. At 30 days, the all-cause mortality rate (i.e, including procedural) was 8% and the combined rate of death, stroke and myocardial infarction was 9.3%.


CONCLUSIONS
The results of this study demonstrate the high rate of procedural success and a low 30-day mortality in a large cohort of high-risk patients undergoing transcatheter aortic valve implantation (TAVI) with the CRS.
Piazza
Nicolo
N
Thoraxcenter, Rotterdam, The Netherlands.
Grube
Eberhard
E
Gerckens
Ulrich
U
den Heijer
Peter
P
Linke
Axel
A
Luha
Olev
O
Ramondo
Angelo
A
Ussia
Giampaolo
G
Wenaweser
Peter
P
Windecker
Stephan
S
Laborde
Jean-Claude
JC
de Jaegere
Peter
P
Serruys
Patrick W
PW
D000368:Aged; D000369:Aged, 80 and over; D001022:Aortic Valve Insufficiency / Q000000981:diagnostic imaging / Q000401:mortality* / Q000601:surgery*; D002423:Cause of Death; D018795:Device Approval; D004452:Echocardiography; D005260:Female; D006350:Heart Valve Prosthesis / Q000706:statistics & numerical data*; D019918:Heart Valve Prosthesis Implantation / Q000401:mortality*; D006801:Humans; D008297:Male; D011183:Postoperative Complications / Q000401:mortality; D011474:Prosthesis Design; D012042:Registries; D012308:Risk Management; D012720:Severity of Illness Index; D016896:Treatment Outcome