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Adverse Effects Associated With Transcatheter Aortic Valve Implantation: A Meta-analysis of Contemporary Studies

Prateek J. Khatri, MD; John G. Webb, MD; Josep Rodés-Cabau, MD; Stephen E. Fremes, MD; Marc Ruel, MD; Kelly Lau, BSc; Helen Guo, MSc; Harindra C. Wijeysundera, MD, PhD; and Dennis T. Ko, MD, MSc
[+] Article, Author, and Disclosure Information

From University of Toronto, Institute for Clinical Evaluative Sciences, and Schulich Heart Centre, Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada; St. Paul's Hospital, University of British Columbia, Vancouver, British Columbia, Canada; Quebec Heart and Lung Institute, Laval University, Québec City, Québec, Canada; and Division of Cardiac Surgery, University of Ottawa, Ottawa, Ontario, Canada.

Grant Support: Dr. Ko is supported by a Canadian Institutes of Health Research New Investigator Award. Study analyses were funded in part by operating grants from the Heart and Stroke Foundation of Canada.

Potential Conflicts of Interest: Disclosures can be viewed at www.acponline.org/authors/icmje/ConflictOfInterestForms.do?msNum=M12-0299.

Requests for Single Reprints: Dennis T. Ko, MD, MSc, Institute for Clinical Evaluative Sciences, G1-06, 2075 Bayview Avenue, Toronto, Ontario M4N 3M5, Canada; e-mail, dennis.ko@ices.on.ca.

Current Author Addresses: Drs. Khatri and Ko, Ms. Lau, and Ms. Guo: Institute for Clinical Evaluative Sciences, G1-06, 2075 Bayview Avenue, Toronto, Ontario M4N 3M5, Canada.

Dr. Webb: University of British Columbia, St. Paul's Hospital, 1081 Burrard Street, Vancouver, British Columbia V6Z 1Y6, Canada.

Dr. Rodés-Cabau: Quebec Heart and Lung Institute, 2725 chemin Ste-Foy, Québec City, Québec G1V 4G5, Canada.

Drs. Fremes and Wijeysundera: Sunnybrook Health Sciences Centre, 2075 Bayview Avenue, Toronto, Ontario M4N 3M5, Canada.

Dr. Ruel: University of Ottawa Heart Institute 40 Ruskin Street, Suite 3403 Ottawa, Ontario K1Y 4W7, Canada.

Author Contributions: Conception and design: P.J. Khatri, M. Ruel, H. Guo, D.T. Ko.

Analysis and interpretation of the data: P.J. Khatri, J.G. Webb, J. Rodés-Cabau, S.E. Fremes, M. Ruel, H. Guo, H.C. Wijeysundera, D.T. Ko.

Drafting of the article: P.J. Khatri, J.G. Webb, D.T. Ko.

Critical revision of the article for important intellectual content: P.J. Khatri, J.G. Webb, J. Rodés-Cabau, S.E. Fremes, M. Ruel, H.C. Wijeysundera, D.T. Ko.

Final approval of the article: P.J. Khatri, J.G. Webb, J. Rodés-Cabau, S.E. Fremes, M. Ruel, H.C. Wijeysundera, D.T. Ko.

Statistical expertise: M. Ruel, H. Guo.

Obtaining of funding: D.T. Ko.

Administrative, technical, or logistic support: K. Lau.

Collection and assembly of data: P.J. Khatri, K. Lau, D.T. Ko.

Ann Intern Med. 2013;158(1):35-46. doi:10.7326/0003-4819-158-1-201301010-00007
Text Size: A A A

Background: Transcatheter aortic valve implantation (TAVI) has emerged as an important treatment for patients with severe symptomatic aortic stenosis who are at high operative risk, but accurate estimates of serious adverse effects in contemporary practice are not available.

Purpose: To quantify the adverse effects associated with TAVI, and to evaluate whether the type of transcatheter valve and the route of valve implantation are associated with differences in adverse outcomes.

Data Source: PubMed to 5 May 2012.

Study Selection: All studies that included at least 100 patients who had TAVI and reported at least 1 outcome of interest.

Data Extraction: Two reviewers abstracted the data independently. A random-effects model was used to combine data on adverse outcomes and conduct stratified analyses.

Data Synthesis: A total of 49 studies enrolling 16 063 patients met the inclusion criteria. Overall 30-day and 1-year survival after TAVI were 91.9% (95% CI, 91.1% to 92.8%) and 79.2% (CI, 76.9% to 81.4%), respectively. Heart block requiring permanent pacemaker implantation was the most common adverse outcome (13.1%) and was 5 times more common with the CoreValve (Medtronic, Minneapolis, Minnesota) than the Sapien valve (Edwards Lifesciences, Irving, California) implanted using the transarterial route (25.2% vs. 5.0%, respectively). The overall rate of vascular complications was 10.4% and was highest with transarterial implantation of the Sapien valve (22.3%). Acute renal failure requiring renal replacement therapy was the third most common complication, occurring in 4.9% of patients.

Limitation: Rates of major vascular complications may be overestimated owing to rapidly evolving TAVI technology.

Conclusion: The most common adverse effects associated with TAVI are heart block, vascular complications, and renal failure. The type of transcatheter valve and the route of implantation are associated with observed variations in the risks for some adverse effects.

Primary Funding Source: Heart and Stroke Foundation of Canada.


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Bleeding: a TAVI complication that urges to be considered
Posted on February 20, 2013
Francesca Giordana, Fabrizio D'Ascenzo, Claudio Moretti, Fiorenzo Gaita
University of Turin
Conflict of Interest: None Declared

The meta-analysis on non adjusted observational studies by Prateek J. Khatri, et al. regarding adverse events associated with trans-catheter aortic valve implantation (TAVI) was of vital clinical interest and very timely (1). In this impressive TAVI patient series, this procedure was associated with an appreciable risk for several important complications, being permanent pacemaker implantation, vascular complications, and requirement for renal replacement therapy the most common ones.

However a frequent and clinically impacting complication of many invasive procedures, both surgical and percutaneous, was omitted: bleeding. We suggest that this gap should be filled for several reasons.


First of all bleeding is really frequent after TAVI procedure, ranging in literature from 5.7% to 44% according to various definitions, and it significantly impacts on prognosis, as it has been highlighted by various studies (2-5). In a multicentre work by our group, bleeding increased in-hospital mortality but not 1-year mortality and, in a recent report by Borz et al., it was an independent predictor of mid-term mortality (5,6). Because of this clinical relevance, bleeding is considered - and classified in life-threatening, major and minor according to severity- in the Valve Academic Research Consortium-2 consensus document, the standard for consistency for  TAVI (7).


Moreover bleeding represents the common pathway for other significant complications after TAVI, that is vascular injuries and acute renal failure, thus worsening patients’ prognosis, especially when blood transfusion is necessary (8,9). The amount of bleeding is usually driven by the rate of vascular complications after TAVI and difference between major vascular complication and the minor ones should be reported, because the latter do not influence patients’ outcome (9).


Moreover, in a recent work by Reinohl et al., bleeding was associated with increased resource use and hospital costs as it significantly increases the total length of stay and the time spent on intensive care unit (10).


Anyhow we consider the Khatri et al. article a very interesting step to better understand how to manage this fragile patient population. Correct clinical identification of the most common adverse events after TAVI and subsequently development of the best strategies to avoid them, will further improve the prognosis of these patients. Besides, considering the numerous comorbidities usually affecting this kind of patients, we urge the search for predictors of adverse outcomes – including major bleeding- in order to improve the selection process of TAVI patients and to work out a risk score suitable for this frail population.



1. Khatri PJ, Webb JG, Rodés-Cabau J, et al. Adverse Effects Associated With Transcatheter Aortic Valve Implantation: A Meta-analysis of Contemporary Studies. Ann Intern Med. 2013 Jan 1;158(1):35-46.

2. Tamburino C, Capodanno D, Ramondo A, et al. Incidence and predictors of early and late mortality after transcatheter aortic valve implantation in 663 patients with severe aortic stenosis. Circulation 2011 Jan 25;123(3):299-308.

3. Wenaweser P, Pilgrim T, Roth N, et al. Clinical outcome and predictors for adverse events after transcatheter aortic valve implantation with the use of different devices and access routes. Am Heart J 2011;161:1114 –24.

4. Rodés-Cabau, J. Webb JG, Cheung A, et al. Long-term Outcomes After Transcatheter Aortic Valve Implantation. J Am Coll Cardiol 2012; 60: 1864-75.

5. Borz B, Durand E, Godin M, et al. Incidence, predictors and impact of bleeding after transcatheter aortic valve implantation using the balloon-expandable Edwards prosthesis. Heart. 2012 Dec 12. (Epub ahead of print)

6. http://www.escardio.org/congresses/EuroPCR/Pages/2012-welcome.aspx

7. Kappetein AP, Head SJ, Généreux P, et al. Updated standardized endpoint definitions for transcatheter aortic valve implantation: the Valve Academic Research Consortium-2 consensus document. J Thorac Cardiovasc Surg. 2013 Jan;145(1):6-23.

8. Nuis RJ, Rodés-Cabau J, Sinning JM, et al. Blood transfusion and the risk of acute kidney injury after transcatheter aortic valve implantation. Circ Cardiovasc Interv. 2012; 5(5):680-8.

9. Tchetche D, Van der Boon RM, Dumonteil N, et al. Adverse impact of bleeding and transfusion on the outcome post-transcatheter aortic valve implantation: insights from the Pooled-RotterdAm-Milano-Toulouse In Collaboration Plus (PRAGMATIC Plus) initiative. Am Heart J. 2012 Sep; 164(3):402-9.

10. Reinohl J, Gutmann A, Kollum M, et al. Transfemoral aortic valve implantation: bleeding events, related costs and outcomes. J Thromb Thrombolysis 2012 Oct 30. (Epub ahead of print)

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