TY - JOUR

T1 - A prospective, randomised trial of transapical transcatheter aortic valve implantation vs. surgical aortic valve replacement in operable elderly patients with aortic stenosis

T2 - the STACCATO trial

AU - Nielsen, Hans H M

AU - Klaaborg, Kaj E

AU - Nissen, Henrik

AU - Terp, Kim

AU - Mortensen, Poul E

AU - Kjeldsen, Bo J

AU - Jakobsen, Carl-Johan

AU - Andersen, Henning R

AU - Egeblad, Henrik

AU - Krusell, Lars R

AU - Thuesen, Leif

AU - Hjortdal, Vibeke E

PY - 2012/7/20

Y1 - 2012/7/20

N2 - AIMS: In a prospective randomised trial we aimed to compare transapical transcatheter aortic valve implantation (a-TAVI) with surgical aortic valve replacement (SAVR) in operable elderly patients.METHODS AND RESULTS: The study was designed as a randomised controlled trial of a-TAVI (Edwards SAPIEN heart valve system; Edwards Lifesciences, Irvine, CA, USA) vs. SAVR. Operable patients with isolated aortic valve stenosis and an age ≥75 years were included. The primary endpoint was the composite of all-cause mortality, cerebral stroke and/or renal failure requiring haemodialysis at 30 days. After advice from the Data Safety Monitoring Board, the study was prematurely terminated after the inclusion of 70 patients because of an excess of events in the a-TAVI group. The primary endpoint was met in five a-TAVI patients (two deaths, two strokes, and one case of renal failure requiring dialysis) vs. one stroke in the SAVR group (p=0.07). In the a-TAVI group, one patient was converted to SAVR because of an abnormally positioned heart, and four patients were re-operated with open heart surgery because of annulus rupture (n=1), severe paravalvular leakage (n=2), and blockage of the left coronary artery (n=1). In the SAVR group, one patient was converted to TAVI because of a large intra-thoracic goitre.CONCLUSIONS: Given the limitations of a small prematurely terminated study, our results suggest that a-TAVI in its present form may be associated with complications and device success rates in low-risk patients similar or even inferior to those found in high-risk patients with aortic valve stenosis. This will probably change in the near future with improved catheter based devices and better pre-procedural assessment.

AB - AIMS: In a prospective randomised trial we aimed to compare transapical transcatheter aortic valve implantation (a-TAVI) with surgical aortic valve replacement (SAVR) in operable elderly patients.METHODS AND RESULTS: The study was designed as a randomised controlled trial of a-TAVI (Edwards SAPIEN heart valve system; Edwards Lifesciences, Irvine, CA, USA) vs. SAVR. Operable patients with isolated aortic valve stenosis and an age ≥75 years were included. The primary endpoint was the composite of all-cause mortality, cerebral stroke and/or renal failure requiring haemodialysis at 30 days. After advice from the Data Safety Monitoring Board, the study was prematurely terminated after the inclusion of 70 patients because of an excess of events in the a-TAVI group. The primary endpoint was met in five a-TAVI patients (two deaths, two strokes, and one case of renal failure requiring dialysis) vs. one stroke in the SAVR group (p=0.07). In the a-TAVI group, one patient was converted to SAVR because of an abnormally positioned heart, and four patients were re-operated with open heart surgery because of annulus rupture (n=1), severe paravalvular leakage (n=2), and blockage of the left coronary artery (n=1). In the SAVR group, one patient was converted to TAVI because of a large intra-thoracic goitre.CONCLUSIONS: Given the limitations of a small prematurely terminated study, our results suggest that a-TAVI in its present form may be associated with complications and device success rates in low-risk patients similar or even inferior to those found in high-risk patients with aortic valve stenosis. This will probably change in the near future with improved catheter based devices and better pre-procedural assessment.

KW - Aged

KW - Aged, 80 and over

KW - Aortic Valve/surgery

KW - Aortic Valve Stenosis/diagnostic imaging

KW - Cardiac Catheterization

KW - Echocardiography

KW - Female

KW - Heart Valve Prosthesis Implantation/adverse effects

KW - Humans

KW - Male

KW - Prospective Studies

KW - Treatment Outcome

U2 - 10.4244/EIJV8I3A58

DO - 10.4244/EIJV8I3A58

M3 - Journal article

C2 - 22581299

VL - 8

SP - 383

EP - 389

JO - EuroIntervention

JF - EuroIntervention

SN - 1774-024X

IS - 3

ER -