Acute and long-term (2-years) clinical outcomes of the CoreValve 31mm in large aortic annuli: A multicenter study.
BACKGROUND
Little is known about the early and late performance of the 31mm CoreValve Revalving System (CRS, Medtronic Inc., Galway, Ireland). Our aim was to compare acute and long-term results of the 31mm CRS with other valve sizes.


METHODS
Consecutive patients undergoing transcatheter aortic valve implantation (TAVI) with CRS in nine Italian centers were prospectively included and dichotomized according to prosthesis size in two different groups, as follows: 31mm and other valve sizes (i.e., 23, 26, and 29mm combined). End points were defined according to Valve Academic Research Consortium definitions. Propensity score matching was performed.


RESULTS
In total, 2069 patients (n=169 [8%] in the 31mm group and n=1900 [92%] in the other valve sizes group) were included. After propensity matching, the implantation of the 31mm valve was associated with lower rates of procedural- (91.3% vs. 98.1%, p=0.030) and device-success (88.5% vs. 97.1%, p=0.016), longer procedural time (120 [80-180] min. vs. 90 [60-120] min., p<0.001), and higher rates of implantation of a second valve (10.6% vs. 2.9%, respectively, p=0.027). The rates of permanent pacemaker implantation in the 31mm group were higher but not statistically different from other valve sizes (41.7% vs. 30.9%, respectively, p=0.149). Significant improvement, without between-group differences, was observed in NYHA functional class. Cardiovascular death was lower in the 31mm valve group through 2-years (3.8% vs. 13.5%, respectively, p=0.014).


CONCLUSIONS
The acute performance of the 31mm CRS was worse than other valve sizes but no negative impact was observed in long-term outcomes.
Ferrarotto Hospital, University of Catania, Catania, Italy. Electronic address: gfattizzani@hotmail.com.
Guilherme F
GF
Attizzani
Ferrarotto Hospital, University of Catania, Catania, Italy.
Yohei
Y
Ohno
Scientific Institute S. Raffaele, Milan.
Azeem
A
Latib
AOU Pisana, Pisa, Italy.
Anna Sonia
AS
Petronio
AOU Pisana, Pisa, Italy.
Cristina
C
Giannini
Ospedali Civili, Brescia, Italy.
Federica
F
Ettori
Ospedali Civili, Brescia, Italy.
Salvatore
S
Curello
IRCCS Policlinico San Donato, San Donato, Italy.
Francesco
F
Bedogni
Ferrarotto Hospital, University of Catania, Catania, Italy.
Denise
D
Todaro
IRCCS Policlinico San Donato, San Donato, Italy.
Nedy
N
Brambilla
"De Gasperis" Cardio Center ASST Niguarda Metropolitan Hospital, Milan, Italy.
Giuseppe
G
Bruschi
"De Gasperis" Cardio Center ASST Niguarda Metropolitan Hospital, Milan, Italy.
Paola
P
Colombo
Clinical Institute Humanitas, Rozzano, Milan, Italy.
Patrizia
P
Presbitero
A. O. San Camillo Forlanini Hospital, Rome, Italy.
Rosario
R
Fiorilli
Ospedale Civile, Legnano, Italy.
Arnaldo
A
Poli
Ospedale Civile, Legnano, Italy.
Paola
P
Martina
Scientific Institute S. Raffaele, Milan.
Antonio
A
Colombo
Ferrarotto Hospital, University of Catania, Catania, Italy.
Marco
M
Barbanti
Ferrarotto Hospital, University of Catania, Catania, Italy.
Corrado
C
Tamburino
D000368:Aged; D000369:Aged, 80 and over; D000704:Analysis of Variance; D001021:Aortic Valve / Q000503:physiopathology* / Q000601:surgery; D001024:Aortic Valve Stenosis / Q000000981:diagnostic imaging / Q000401:mortality / Q000601:surgery*; D001705:Bioprosthesis; D015331:Cohort Studies; D005260:Female; D005500:Follow-Up Studies; D006350:Heart Valve Prosthesis; D006801:Humans; D007558:Italy; D053208:Kaplan-Meier Estimate; D008297:Male; D057216:Propensity Score; D011446:Prospective Studies; D011474:Prosthesis Design; D011475:Prosthesis Failure; D018570:Risk Assessment; D012720:Severity of Illness Index; D018709:Statistics, Nonparametric; D016019:Survival Analysis; D013997:Time Factors; D065467:Transcatheter Aortic Valve Replacement / Q000379:methods* / Q000401:mortality; D016896:Treatment Outcome
CoreValve; Large annulus; TAVI; TAVR