Incidence, predictors and prognostic value of serious hemorrhagic complications following transcatheter aortic valve implantation.
BACKGROUND
TAVI is an alternative solution for patients with aortic valve stenosis (AS) who are refused for conventional surgery. We sought to evaluate the incidence, characteristics, predictors and prognosis impact of serious hemorrhagic complications following transcatheter aortic valve implantation (TAVI).


METHODS
One hundred and seventy one consecutive patients with symptomatic severe AS (83.5 ± 6.1 y; 53% women; mean EuroSCORE=22.1 ± 12.3) underwent transapical (TA) or transfemoral (TF) TAVI in our institution using Edwards SAPIEN© and Medtronic CoreValve© devices. The primary evaluated criterion was the incidence of any bleeding complication, according to the Valve Academic Research Consortium (VARC) criteria.


RESULTS
VARC serious hemorrhagic complications occurred in 34.5% of patients (n=23 life-threatening/disabling (LT/D) and n=36 major bleedings). Most of these complications were related to access site complications (69%). Multivariable analysis revealed that TA access, low weight and underlying coronary artery diseases were independent predictors for development of serious bleeding. The mortality was significantly higher in patients with serious events compared to patients without bleeding (p=0.008, log-rank analysis). Although the survival didn't significantly differ in patients with major hemorrhagic events, subjects with LT/D bleeding events had a higher mortality than the subjects with no hemorrhagic complications (p<0.001, log-rank analysis). Occurrence of VARC LT/D event independently predicted all-cause mortality (HR=5.35 [2.51-11.43], p<0.001) during the first year following TAVI in multivariate Cox regression analysis.


CONCLUSIONS
Severe bleeding is frequent following TAVI procedure and is mainly related to local hemorrhage. VARC LT/D events are associated with decreased survival after AS correction.
Department of Cardiology, Centre Marie Lannelongue, Le Plessis-Robinson, France. n.amabile@ccml.fr
Nicolas
N
Amabile
Alexandre
A
Azmoun
Said
S
Ghostine
Ramzi
R
Ramadan
Yacine
Y
Haddouche
François
F
Raoux
Ngoc-Tram
NT
To
Xavier
X
Troussier
Remi
R
Nottin
Christophe
C
Caussin
D000368:Aged; D000369:Aged, 80 and over; D001024:Aortic Valve Stenosis / Q000175:diagnosis / Q000453:epidemiology* / Q000601:surgery*; D006328:Cardiac Catheterization / Q000009:adverse effects*; D015331:Cohort Studies; D005260:Female; D005500:Follow-Up Studies; D019918:Heart Valve Prosthesis Implantation / Q000009:adverse effects*; D006801:Humans; D015994:Incidence; D008297:Male; D019106:Postoperative Hemorrhage / Q000175:diagnosis / Q000453:epidemiology*; D011237:Predictive Value of Tests; D011379:Prognosis; D016896:Treatment Outcome