• Am. J. Cardiol. · May 2016

    Multicenter Study Observational Study

    Early and Midterm Outcome of Propensity-Matched Intermediate-Risk Patients Aged ≥80 Years With Aortic Stenosis Undergoing Surgical or Transcatheter Aortic Valve Replacement (from the Italian Multicenter OBSERVANT Study).

    • Chiara Fraccaro, Giuseppe Tarantini, Stefano Rosato, Paola Tellaroli, Paola D'Errigo, Corrado Tamburino, Francesco Onorati, Marco Ranucci, Marco Barbanti, Claudio Grossi, Gennaro Santoro, Francesco Santini, Remo Daniel Covello, Danilo Fusco, Fulvia Seccareccia, and OBSERVANT Research Group.
    • Division of Cardiology, Department of Cardiac, Thoracic and Vascular Sciences, University of Padova, Padova, Italy. Electronic address: chiara_fraccaro@hotmail.com.
    • Am. J. Cardiol. 2016 May 1; 117 (9): 1494-501.

    AbstractThe aim of this study was to analyze procedural and postprocedural outcomes of patients aged ≥80 years treated by transcatheter aortic valve implantation (TAVI) or surgical aortic valve replacement (SAVR) as enrolled in the OBservational Study of Effectiveness of SAVR-TAVR procedures for severe Aortic steNosis Treatment (OBSERVANT) Study. TAVI is offered to patients with aortic stenosis judged inoperable or at high surgical risk. Nevertheless, it is common clinical practice to treat elderly (≥80 years) patients by TAVI regardless of surgical risk for traditional SAVR. OBSERVANT is a multicenter, observational, prospective cohort study that enrolled patients with symptomatic severe aortic stenosis who underwent SAVR or TAVI from December 2010 to June 2012 in 93 Italian participating hospitals. Information on demographic characteristics, health status before intervention, therapeutic approach, and intraprocedural and 30-day outcomes was collected. An administrative follow-up was set up to collect data on midterm to long-term outcomes. We reviewed baseline and procedural data of patients aged ≥80 years, looking for different early and late outcome after TAVI or SAVR. Patients treated by TAVI were sicker than SAVR because of higher rate of co-morbidities, advanced illness, frailty, and Logistic EuroSCORE. After propensity matching, early and midterm mortality were comparable between the 2 groups. However, patients treated by TAVI had higher rate of vascular complications (6.0% vs 0.5%; p <0.0001), permanent pacemaker implantation (13.4% vs 3.7%; p <0.0001), and paravalvular leak (8.9% vs 2.4%; p <0.0001). Patients who underwent SAVR had more frequent bleedings needing transfusion (63.2% vs 34.5%; p <0.0001) and acute kidney injury (9.6% vs 3.9%; p = 0.0010). In conclusion, patients aged ≥80 years treated by TAVI or SAVR had similar early and midterm mortality.Copyright © 2016 Elsevier Inc. All rights reserved.

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