Expansion of the indication of transcatheter aortic valve implantation--feasibility and outcome in "off-label" patients compared with "on-label" patients.
BACKGROUND
We compare the feasibility and outcomes of "off-label" transcatheter aortic valve implantation (TAVI) patients with a standard "on-label" TAVI population.


METHODS
A total of 591 high-risk patients (pts) underwent a TAVI procedure at our institution. Of these, 435 pts (73.6%) were treated for an on-label indication (group A) and 156 pts (26.4%) were treated for an off-label indication (group B). Group B was further subdivided into patients with pure aortic regurgitation (n = 22; group B.1), anatomical considerations (n = 26; group B.2), very low ejection fraction ≤20% (n = 12; group B.3), concomitant severe mitral regurgitation >2+ (n = 44; group B.4), degenerated aortic bioprosthesis (n = 30; group B.5), and hemodynamic instability with the need for cardiopulmonary bypass (n = 22; group B.6). Outcome parameters were classified according to the Valve Academic Research Consortium-2 criteria.


RESULTS
The mean log EuroSCORE of the entire study group was 25 ± 16% (33 ± 21% in group B vs 22 ± 14% in group A; P<.001). Overall device success was 90% (91.3% in group A vs 86.5% in group B; P=.02). Overall 30-day mortality was 9.7%. Group B had a higher 30-day mortality compared with group A (14.7% vs 7.8%, respectively; P=.01). Group B.5 had the lowest 30-day mortality (3.3%).


CONCLUSIONS
Corresponding to the higher surgical risk of group B, 30-day mortality was higher for off-label pts. Patients treated as valve-in-valve had the lowest 30-day mortality, emphasizing its great potential as opposed to redo open-heart surgery.
Asklepios Klinik St. Georg, Division of Cardiology, Lohmühlenstr. 5, 20099 Hamburg, Germany. c.frerker@asklepios.com.
Christian
C
Frerker
Jury
J
Schewel
Dimitry
D
Schewel
Peter
P
Wohlmuth
Tobias
T
Schmidt
Felix
F
Kreidel
Ralf
R
Bader
Karl-Heinz
KH
Kuck
Ulrich
U
Schäfer
D000369:Aged, 80 and over; D001021:Aortic Valve / Q000601:surgery*; D001024:Aortic Valve Stenosis / Q000175:diagnosis / Q000601:surgery*; D001705:Bioprosthesis; D005240:Feasibility Studies; D005260:Female; D005500:Follow-Up Studies; D006350:Heart Valve Prosthesis; D006801:Humans; D008297:Male; D018579:Patient Selection; D011474:Prosthesis Design; D012189:Retrospective Studies; D012307:Risk Factors; D065467:Transcatheter Aortic Valve Replacement / Q000379:methods*; D016896:Treatment Outcome