Transcatheter aortic valve implantation for high risk patients with severe aortic stenosis using the Edwards Sapien balloon-expandable bioprosthesis: a single centre study with immediate and medium-term outcomes.
BACKGROUND
Transcatheter aortic valve implantation (TCAVI) is an emerging alternative therapy to open-heart surgery in high-risk patients with symptomatic aortic stenosis.


METHODS
Between January 2007 and May 2009, 46 patients underwent TCAVI with the 23 mm or 26 mm Edwards Sapien bioprosthesis via either the transapical (TA-AVI) or transfemoral (TF-AVI) approach. All patients had an estimated operative mortality risk of >15%.


RESULTS
A total of 46 patients (30 TA-AVI, 16 TF-AVI) with a mean aortic valve area (AVA) of 0.63 +/- 0.2 cm(2) and mean gradient of 54 +/- 16 mm Hg were treated. Predicted operative mortality was 25.3% by logistic Euroscore and 8.7% by Society of Thoracic Surgeons risk score. Procedural success was 93% in the TA-AVI group and 88% in the TF-AVI group. There was one intraprocedural death in the TA-AVI group. Overall 30-day mortality was 6.5% (2-TA-AVI, 1-TF-AVI). Four patients (9.5%) died from noncardiac causes after 30 days. Successful TCAVI was associated with a significant increase in AVA from 0.6 +/- 0.1 cm(2) to 1.6 +/- 0.6 cm(2) in the TA-AVI group and 0.6 +/- 0.1 cm(2) to 1.4 +/- 0.2 cm(2) in the TF-AVI group at a mean follow up of 7.4 +/- 4.4 and 8.3 +/- 5.0 months, respectively. At discharge, there was significant improvement in AVA (P < 0.0001), transaortic mean gradient (P < 0.0001), and mitral regurgitation (P = 0.01). At medium term follow up, the valve area was maintained and there was significant improvement in NYHA class in both groups (P < 0.0001).


CONCLUSIONS
At medium term follow-up, both transcatheter approaches demonstrated good valve durability with no cardiac-related mortality post hospital discharge.
Osten
Mark D
MD
Department of Medicine, Division of Cardiology, University Health Network, Toronto General Hospital, Toronto, Ontario, Canada.
Feindel
Christopher
C
Greutmann
Matthias
M
Chamberlain
Kristeen
K
Meineri
Massimiliano
M
Rubin
Barry
B
Mezody
Melitta
M
Ivanov
Joan
J
Butany
Jagdish
J
Horlick
Eric M
EM
D000368:Aged; D000369:Aged, 80 and over; D001024:Aortic Valve Stenosis / Q000175:diagnosis / Q000401:mortality / Q000503:physiopathology / Q000628:therapy*; D001705:Bioprosthesis; D006328:Cardiac Catheterization / Q000009:adverse effects / Q000295:instrumentation* / Q000401:mortality; D002404:Catheterization / Q000009:adverse effects / Q000295:instrumentation* / Q000401:mortality; D017023:Coronary Angiography; D018618:Echocardiography, Doppler, Color; D005260:Female; D006350:Heart Valve Prosthesis; D019918:Heart Valve Prosthesis Implantation / Q000009:adverse effects / Q000295:instrumentation* / Q000379:methods / Q000401:mortality; D006439:Hemodynamics; D017052:Hospital Mortality; D006801:Humans; D053208:Kaplan-Meier Estimate; D016015:Logistic Models; D008297:Male; D009864:Ontario; D018579:Patient Selection; D011474:Prosthesis Design; D020127:Recovery of Function; D012189:Retrospective Studies; D018570:Risk Assessment; D012307:Risk Factors; D012720:Severity of Illness Index; D013997:Time Factors; D014057:Tomography, X-Ray Computed; D016896:Treatment Outcome