Transcatheter Aortic Valve Implantation for the Treatment of Severe Symptomatic Aortic Stenosis in Patients at Very High or Prohibitive Surgical Risk: Acute and Late Outcomes of the Multicenter Canadian Experience

J Am Coll Cardiol. 2010; 55(3):1080-1090

Josep Rodés-Cabau, John G. Webb, Anson Cheung, Jian Ye, Eric Dumont, Christopher M. Feindel, Mark Osten, Madhu K. Natarajan, James L. Velianou, Giuseppe Martucci, Benoît DeVarennes, Robert Chisholm, Mark D. Peterson, Samuel V. Lichtenstein, Fabian Nietlispach, Daniel Doyle, Robert DeLarochellière, Kevin Teoh, Victor Chu, Adrian Dancea, Kevin Lachapelle, Asim Cheema, David Latter, Eric Horlick

OBJECTIVES: The aim of this study was: 1) to evaluate the acute and late outcomes of a transcatheter aortic valve implantation (TAVI) program including both the transfemoral (TF) and transapical (TA) approaches; and 2) to determine the results of TAVI in patients deemed inoperable because of either porcelain aorta or frailty. Very few data exist on the results of a comprehensive TAVI program including both TA and TF approaches for the treatment of severe aortic stenosis in patients at very high or prohibitive surgical risk.

METHODS: Consecutive patients who underwent TAVI with the Edwards valve (Edwards Lifesciences, Inc., Irvine, California) between January 2005 and June 2009 in 6 Canadian centers were included.

RESULTS: A total of 345 procedures (TF: 168, TA: 177) were performed in 339 patients. The predicted surgical mortality (Society of Thoracic Surgeons risk score) was 9.8 ± 6.4%. The procedural success rate was 93.3%, and 30-day mortality was 10.4% (TF: 9.5%, TA: 11.3%). After a median follow-up of 8 months (25th to 75th interquartile range: 3 to 14 months) the mortality rate was 22.1%. The predictors of cumulative late mortality were peri-procedural sepsis (hazard ratio [HR]: 3.49, 95% confidence interval [CI]: 1.48 to 8.28) or need for hemodynamic support (HR: 2.58, 95% CI: 1.11 to 6), pulmonary hypertension (PH) (HR: 1.88, 95% CI: 1.17 to 3), chronic kidney disease (CKD) (HR: 2.30, 95% CI: 1.38 to 3.84), and chronic obstructive pulmonary disease (COPD) (HR: 1.75, 95% CI: 1.09 to 2.83). Patients with either porcelain aorta (18%) or frailty (25%) exhibited acute outcomes similar to the rest of the study population, and porcelain aorta patients tended to have a better survival rate at 1-year follow-up.

CONCLUSIONS: A TAVI program including both TF and TA approaches was associated with comparable mortality as predicted by surgical risk calculators for the treatment of patients at very high or prohibitive surgical risk, including porcelain aorta and frail patients. Baseline (PH, COPD, CKD) and peri-procedural (hemodynamic support, sepsis) factors but not the approach determined worse outcomes.

PMID: 20096533

2 Responses

  1. Paul Schoenhagen, MD  on March 9th, 2010

    I have posted several recent manuscripts about imaging in the context of TAVI. This paper describes clinical outcome.

    See associated editorial also:

    A Step Forward in the Evaluation of Transcatheter Aortic Valve Implantation.
    Bernard Iung, Dominique Himbert, and Alec Vahanian.
    J Am Coll Cardiol 2010;55 1091-1092.
    PMID: 20137878

  2. Paul Schoenhagen  on August 3rd, 2010

    Short- and Medium-Term Outcomes After Transcatheter Pulmonary Valve Placement in the Expanded Multicenter US Melody Valve Trial.
    Doff B. McElhinney, William E. Hellenbrand, Evan M. Zahn, Thomas K. Jones, John P. Cheatham, James E. Lock, and Julie A. Vincent.
    Circulation 2010;122 507-516.
    PMID: 20644013


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