• J. Am. Coll. Cardiol. · Mar 2014

    Randomized Controlled Trial Comparative Study

    Bleeding complications after surgical aortic valve replacement compared with transcatheter aortic valve replacement: insights from the PARTNER I Trial (Placement of Aortic Transcatheter Valve).

    • Philippe Généreux, David J Cohen, Mathew R Williams, Michael Mack, Susheel K Kodali, Lars G Svensson, Ajay J Kirtane, Ke Xu, Thomas C McAndrew, Raj Makkar, Craig R Smith, and Martin B Leon.
    • Columbia University Medical Center/New York Presbyterian Hospital, New York, New York; Cardiovascular Research Foundation, New York, New York; Hôpital du Sacré-Coeur de Montréal, Montréal, Québec, Canada.
    • J. Am. Coll. Cardiol. 2014 Mar 25;63(11):1100-9.

    ObjectivesThis study sought to identify the incidence, predictors, and prognostic impact of bleeding complications (BC) after surgical aortic valve replacement (SAVR) compared with transcatheter aortic valve replacement (TAVR).BackgroundBleeding complications after SAVR and TAVR are frequent and may be associated with an unfavorable prognosis.MethodsIn the randomized controlled PARTNER (Placement of Aortic Transcatheter Valve) I trial, 657 patients from cohort A (operable high risk) were randomly assigned to SAVR or TAVR (transfemoral [TF] if iliofemoral access was suitable or transapical [TA] if not) and received the designated treatment. First-generation Edwards SAPIEN valves and delivery systems (Edwards Lifesciences, Irvine, California) were used for TAVR, through a 22- or 24-F sheath. The 30-day rates of major BC (modified Valve Academic Research Consortium definitions), predictors of BC, and their association with 1-year mortality were assessed.ResultsA total of 71 (22.7%), 27 (11.3%), and 9 (8.8%) patients had major BC within 30 days of the procedure after SAVR, TF-TAVR, and TA-TAVR, respectively (p < 0.0001). SAVR was associated with a significantly higher 30-day rate of transfusion (17.9%) than either TF-TAVR (7.1%) or TA-TAVR (4.8%; p < 0.0001). Independent predictors of major BC were the occurrence of major vascular complications and use of intraprocedural hemodynamic support among TF-TAVR patients, severe procedural complications requiring conversion to open surgery among TA-TAVR patients, and the presence of low hemoglobin at baseline among SAVR patients. Major BC was identified as the strongest independent predictor of 1-year mortality among the full cohort. However, risk-adjusted analyses demonstrated a significant interaction between BC and treatment strategy with respect to mortality, suggesting that BC after SAVR have a greater impact on prognosis than after TAVR.ConclusionsAmong high-risk aortic stenosis patients enrolled in the PARTNER I randomized trial, BC were more common after SAVR than after TAVR and were also associated with a worse long-term prognosis. (THE PARTNER TRIAL: Placement of AoRTic TraNscathetER Valve Trial; NCT00530894).Copyright © 2014 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

      Pubmed     Free full text   Copy Citation     Plaintext  

      Add institutional full text...

    Notes

     
    Knowledge, pearl, summary or comment to share?
    300 characters remaining
    help        
    You can also include formatting, links, images and footnotes in your notes
    • Simple formatting can be added to notes, such as *italics*, _underline_ or **bold**.
    • Superscript can be denoted by <sup>text</sup> and subscript <sub>text</sub>.
    • Numbered or bulleted lists can be created using either numbered lines 1. 2. 3., hyphens - or asterisks *.
    • Links can be included with: [my link to pubmed](http://pubmed.com)
    • Images can be included with: ![alt text](https://bestmedicaljournal.com/study_graph.jpg "Image Title Text")
    • For footnotes use [^1](This is a footnote.) inline.
    • Or use an inline reference [^1] to refer to a longer footnote elseweher in the document [^1]: This is a long footnote..

    hide…