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J Am Coll Cardiol, 2010; 55:1080-1090, doi:10.1016/j.jacc.2009.12.014 (Published online 20 January 2010).
© 2010 by the American College of Cardiology Foundation
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EXPEDITED PUBLICATION

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

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

* Quebec Heart and Lung Institute, Laval University, Quebec City, Quebec, Canada
{dagger} St Paul's Hospital, University of British Columbia, Vancouver, British Columbia, Canada
{ddagger} Toronto General Hospital, University of Toronto, Toronto, Ontario, Canada
§ Hamilton General Hospital, McMaster University, Hamilton, Ontario, Canada
|| Royal Victoria Hospital, McGill University, Montreal, Quebec, Canada
St. Michael's Hospital, University of Toronto, Toronto, Ontario, Canada. Drs. Rodés-Cabau, Webb, Cheung, Ye, Dumont, DeVarennes, and Horlick are consultants for Edwards Lifesciences, Inc. Dr. Cheung is a speaker for Edwards Lifesciences Inc. Dr. Ye has received a small amount of honoraria from Edwards Lifesciences Inc. Dr. DeVarennes is a consultants for ATS Medical

Manuscript received October 2, 2009; revised manuscript received November 11, 2009, accepted December 17, 2009.

* Reprint requests and correspondence: Dr. Josep Rodés-Cabau, Quebec Heart and Lung Institute, Laval University, 2725 Chemin Ste-Foy, G1V 4G5 Quebec City, Canada (Email: josep.rodes{at}criucpq.ulaval.ca).

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.

Background: 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.

Key Words: transapical • transcatheter aortic valve implantation • transfemoral • valves

Abbreviations and Acronyms
  CI = confidence interval
  CKD = chronic kidney disease
  COPD = chronic obstructive pulmonary disease
  HR = hazard ratio
  MI = myocardial infarction
  MR = mitral regurgitation
  OR = odds ratio
  PH = pulmonary hypertension
  SAVR = surgical aortic valve replacement
  STS-PROM = Society of Thoracic Surgeons Predicted Risk of Mortality
  TA = transapical
  TAVI = transcatheter aortic valve implantation
  TF = transfemoral


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Ann. Thorac. Surg., March 1, 2011; 91(3): 685 - 691.
[Abstract] [Full Text] [PDF]

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A. W. Cheung, R. Gurvitch, J. Ye, D. Wood, S. V. Lichtenstein, C. Thompson, and J. G. Webb
Transcatheter transapical mitral valve-in-valve implantations for a failed bioprosthesis: A case series
J. Thorac. Cardiovasc. Surg., March 1, 2011; 141(3): 711 - 715.
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A. W. ElBardissi, P. Shekar, G. S. Couper, and L. H. Cohn
Minimally invasive aortic valve replacement in octogenarian, high-risk, transcatheter aortic valve implantation candidates
J. Thorac. Cardiovasc. Surg., February 1, 2011; 141(2): 328 - 335.
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R. Bagur, J. Rodes-Cabau, D. Doyle, R. De Larochelliere, J. Villeneuve, J. Lemieux, S. Bergeron, M. Cote, O. F. Bertrand, P. Pibarot, et al.
Usefulness of TEE as the Primary Imaging Technique to Guide Transcatheter Transapical Aortic Valve Implantation
J. Am. Coll. Cardiol. Img., February 1, 2011; 4(2): 115 - 124.
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M. G. D. Bates, I. G. Matthews, I. A. Fazal, and A. J. Turley
Postoperative permanent pacemaker implantation in patients undergoing trans-catheter aortic valve implantation: what is the incidence and are there any predicting factors?
Interact CardioVasc Thorac Surg, February 1, 2011; 12(2): 243 - 253.
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A. N. DeMaria, J. J. Bax, O. Ben-Yehuda, G. K. Feld, B. H. Greenberg, J. Hall, M. Hlatky, W. Y. W. Lew, J. A. C. Lima, A. S. Maisel, et al.
Highlights of the Year in JACC 2010
J. Am. Coll. Cardiol., January 25, 2011; 57(4): 480 - 514.
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C. Tamburino, D. Capodanno, A. Ramondo, A. S. Petronio, F. Ettori, G. Santoro, S. Klugmann, F. Bedogni, F. Maisano, A. Marzocchi, et al.
Incidence and Predictors of Early and Late Mortality After Transcatheter Aortic Valve Implantation in 663 Patients With Severe Aortic Stenosis
Circulation, January 25, 2011; 123(3): 299 - 308.
[Abstract] [Full Text] [PDF]

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J. L. d'Arcy, B. D. Prendergast, J. B. Chambers, S. G. Ray, and B. Bridgewater
Valvular heart disease: the next cardiac epidemic
Heart, January 15, 2011; 97(2): 91 - 93.
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J. Rodes-Cabau, E. Dumont, R. H. Boone, E. Larose, R. Bagur, R. Gurvitch, F. Bedard, D. Doyle, R. De Larochelliere, C. Jayasuria, et al.
Cerebral Embolism Following Transcatheter Aortic Valve Implantation: Comparison of Transfemoral and Transapical Approaches
J. Am. Coll. Cardiol., January 4, 2011; 57(1): 18 - 28.
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H. Eltchaninoff, A. Prat, M. Gilard, A. Leguerrier, D. Blanchard, G. Fournial, B. Iung, P. Donzeau-Gouge, C. Tribouilloy, J.-L. Debrux, et al.
Transcatheter aortic valve implantation: early results of the FRANCE (FRench Aortic National CoreValve and Edwards) registry
Eur. Heart J., January 2, 2011; 32(2): 191 - 197.
[Abstract] [Full Text] [PDF]

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T. Lefevre, A. P. Kappetein, E. Wolner, P. Nataf, M. Thomas, V. Schachinger, B. De Bruyne, H. Eltchaninoff, M. Thielmann, D. Himbert, et al.
One year follow-up of the multi-centre European PARTNER transcatheter heart valve study
Eur. Heart J., January 2, 2011; 32(2): 148 - 157.
[Abstract] [Full Text] [PDF]

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M. Johansson, S. Nozohoor, P. O. Kimblad, J. Harnek, G. K. Olivecrona, and J. Sjogren
Transapical Versus Transfemoral Aortic Valve Implantation: A Comparison of Survival and Safety
Ann. Thorac. Surg., January 1, 2011; 91(1): 57 - 63.
[Abstract] [Full Text] [PDF]

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M. A. Clavel, J. G. Webb, J. Rodes-Cabau, J. B. Masson, E. Dumont, R. De Larochelliere, D. Doyle, S. Bergeron, H. Baumgartner, I. G. Burwash, et al.
Comparison Between Transcatheter and Surgical Prosthetic Valve Implantation in Patients With Severe Aortic Stenosis and Reduced Left Ventricular Ejection Fraction
Circulation, November 9, 2010; 122(19): 1928 - 1936.
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M. Pasic, S. Buz, S. Dreysse, T. Drews, A. Unbehaun, C. Klein, M. Kukucka, A. Mladenow, E. Ivanitskaia-Kuhn, and R. Hetzer
Transapical Aortic Valve Implantation in 194 Patients: Problems, Complications, and Solutions
Ann. Thorac. Surg., November 1, 2010; 90(5): 1463 - 1470.
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J.-M. Sinning, A. Ghanem, H. Steinhauser, V. Adenauer, C. Hammerstingl, G. Nickenig, and N. Werner
Renal Function as Predictor of Mortality in Patients After Percutaneous Transcatheter Aortic Valve Implantation
J. Am. Coll. Cardiol. Intv., November 1, 2010; 3(11): 1141 - 1149.
[Abstract] [Full Text] [PDF]

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R. Schueler, C. Hammerstingl, J.-M. Sinning, G. Nickenig, and H. Omran
Prognosis of octogenarians with severe aortic valve stenosis at high risk for cardiovascular surgery
Heart, November 1, 2010; 96(22): 1831 - 1836.
[Abstract] [Full Text] [PDF]

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S. W. Grant, M. P. Devbhandari, A. D. Grayson, I. Dimarakis, I. Kadir, D. M. T. Saravanan, R. D. Levy, S. G. Ray, and B. Bridgewater
What is the impact of providing a transcatheter aortic valve implantation service on conventional aortic valve surgical activity: patient risk factors and outcomes in the first 2 years
Heart, October 15, 2010; 96(20): 1633 - 1637.
[Abstract] [Full Text] [PDF]

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R. R. Coeytaux, J. W. Williams Jr., R. N. Gray, and A. Wang
Percutaneous Heart Valve Replacement for Aortic Stenosis: State of the Evidence
Ann Intern Med, September 7, 2010; 153(5): 314 - 324.
[Abstract] [Full Text] [PDF]

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E. M. Tuzcu, S. R. Kapadia, and L. G. Svensson
"SOURCE" of Enthusiasm for Transcatheter Aortic Valve Implantation
Circulation, July 6, 2010; 122(1): 8 - 10.
[Full Text] [PDF]

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B. A. Carabello
Percutaneous Therapy for Valvular Heart Disease: A Huge Advance and a Huge Challenge to Do it Right
Circulation, April 27, 2010; 121(16): 1798 - 1799.
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Transcatheter Aortic Valve Implantation: The Canadian Experience
Journal Watch Cardiology, April 7, 2010; 2010(407): 2 - 2.
[Full Text]

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B. Iung, D. Himbert, and A. Vahanian
A Step Forward in the Evaluation of Transcatheter Aortic Valve Implantation
J. Am. Coll. Cardiol., March 16, 2010; 55(11): 1091 - 1092.
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