Focus Issue: Structural Heart Disease
Transcatheter Aortic Valve Implantation: Clinical Research
Clinical Outcomes of Patients With Severe Aortic Stenosis at Increased Surgical Risk According to Treatment Modality

https://doi.org/10.1016/j.jacc.2011.05.063Get rights and content
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Objectives

The aim of this study was to assess the role of transcatheter aortic valve implantation (TAVI) compared with medical treatment (MT) and surgical aortic valve replacement (SAVR) in patients with severe aortic stenosis (AS) at increased surgical risk.

Background

Elderly patients with comorbidities are at considerable risk for SAVR.

Methods

Since July 2007, 442 patients with severe AS (age: 81.7 ± 6.0 years, mean logistic European System for Cardiac Operative Risk Evaluation: 22.3 ± 14.6%) underwent treatment allocation to MT (n = 78), SAVR (n = 107), or TAVI (n = 257) on the basis of a comprehensive evaluation protocol as part of a prospective registry.

Results

Baseline clinical characteristics were similar among patients allocated to MT and TAVI, whereas patients allocated to SAVR were younger (p < 0.001) and had a lower predicted peri-operative risk (p < 0.001). Unadjusted rates of all-cause mortality at 30 months were lower for SAVR (22.4%) and TAVI (22.6%) compared with MT (61.5%, p < 0.001). Adjusted hazard ratios for death were 0.51 (95% confidence interval: 0.30 to 0.87) for SAVR compared with MT and 0.38 (95% confidence interval: 0.25 to 0.58) for TAVI compared with MT. Medical treatment (<0.001), older age (>80 years, p = 0.01), peripheral vascular disease (<0.001), and atrial fibrillation (p = 0.04) were significantly associated with all-cause mortality at 30 months in the multivariate analysis. At 1 year, more patients undergoing SAVR (92.3%) or TAVI (93.2%) had New York Heart Association functional class I/II as compared with patients with MT (70.8%, p = 0.003).

Conclusions

Among patients with severe AS with increased surgical risk, SAVR and TAVI improve survival and symptoms compared with MT. Clinical outcomes of TAVI and SAVR seem similar among carefully selected patients with severe symptomatic AS at increased risk.

Key Words

aortic stenosis
surgical aortic valve replacement
transcatheter aortic valve implantation

Abbreviations and Acronyms

AS
aortic stenosis
CABG
coronary artery bypass grafting
CI
confidence interval
CT
computed tomography
ESV
Edwards Sapien valve
EuroSCORE
European System for Cardiac Operative Risk Evaluation
MACCE
major adverse cerebro-cardiovascular event(s)
MCRS
Medtronic CoreValve Revalving system
MI
myocardial infarction
MT
medical treatment
PCI
percutaneous coronary intervention
PRBC
packed red blood cells
RIFLE
Risk, Injury, Failure, Loss, End-stage kidney disease
SAVR
surgical aortic valve replacement
TAVI
transcatheter aortic valve implantation
URL
upper reference limit

Cited by (0)

Dr. Wenaweser is a proctor and receives honoraria from Medtronic CoreValve and Edwards LifeSciences. Dr. Buellesfeld is a consultant for Medtronic. Dr. Khattab has received speaker honoraria and proctor fees from Medtronic CoreValve and Edwards LifeSciences. Dr. Eberle has received lecture honoraria from Medtronic CoreValve. Dr. Meier has received research grants from Medtronic and Abbott. Dr. Jüni is an unpaid member of steering groups and executive committees of trials funded by Abbott Vascular, Biosensors, Cordis, and Medtronic. Dr. Windecker has received lecture and consultant fees from Edwards LifeSciences and Medtronic CoreValve. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose. Drs. Wenaweser and Pilgrim contributed equally to this work.