Valvular Heart Disease
Feasibility and Safety of Transcatheter Aortic Valve Implantation Performed Without Intensive Care Unit Admission

https://doi.org/10.1016/j.amjcard.2016.04.019Get rights and content

Admission to the intensive care unit (ICU) is a standard of care after transcatheter aortic valve implantation (TAVI); however, the improvement of the procedure and the need to minimize the unnecessary use of medical resources call into question this strategy. We evaluated prospectively 177 consecutive patients who underwent TAVI. Low-risk patients, admitted to conventional cardiology units, had stable clinical state, transfemoral access, no right bundle branch block, permanent pacing with a self-expandable valve, and no complication occurring during the procedure. High-risk patients included all the others transferred to ICU. In-hospital events were the primary end point (Valve Academic Research Consortium 2 criteria). The mean age of patients was 83.5 ± 6.5 years, and the mean logistic EuroSCORE was 14.6 ± 9.7%. The balloon-expandable SAPIEN 3 valve was mainly used (n = 148; 83.6%), mostly with transfemoral access (n = 167; 94.4%). Among the 61 patients (34.5%) included in the low-risk group, only 1 (1.6%) had a minor complication (negative predictive value 98.4%, 95% confidence interval [CI] 0.91 to 0.99). Conversely, 31 patients (26.7%) from the high-risk group had clinical events (positive predictive value 26.7%, 95% CI 0.19 to 0.35), mainly conductive disorders requiring pacemaker (n = 26; 14.7%). In multivariate analysis, right bundle branch block (odds ratio [OR] 14.1, 95% CI 3.5 to 56.3), use of the self-expandable valve without a pacemaker (OR 5.5, 95% CI 2 to 16.3), vitamin K antagonist treatment (OR 3.8, 95% CI 1.1 to 12.6), and female gender (OR 2.6, 95% CI 1.003 to 6.9) were preprocedural predictive factors of adverse events. In conclusion, our results suggested that TAVI can be performed safely without ICU admission in selected patients. This strategy may optimize efficiency and cost-effectiveness of procedures.

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Methods

Between December 2014 and July 2015, all consecutive patients who underwent TAVI in our center were included in a monocentric prospective study. Exclusion criteria included valve-in-valve procedures and transaortic or transapical approaches. The procedures were performed in the catheterization laboratory using the new-generation balloon-expandable Edwards SAPIEN 3 bovine pericardial device (Edwards Lifesciences, Irvine, California) or the self-expandable CoreValve porcine pericardial device

Results

The study enrolled 177 patients, 61 (34.5%) were classified in the low-risk group and 116 (65.5%) in the high-risk group according to the predefined criteria. Except for the risk factors in the criteria defining low- versus high-risk groups in our study, the clinical characteristics between the groups of patients only differed by the logistic EuroSCORE (p = 0.011; Table 3). Most TAVIs were performed under general anesthesia with orotracheal intubation (n = 170, 96.1%) and with transfemoral

Discussion

The main results of this study were as follows: (1) TAVI may be performed safely without subsequent ICU admission using simple patient and procedural selection criteria; (2) postprocedural complications included mainly conductive disorders with a very low rate of major vascular and bleeding events; (3) the main predictive factors of complications in our study included preprocedural RBBB, self-expandable prosthesis implantation, use of VKA therapy, and conductive disorders occurring during the

Acknowledgment

We thank Valérie Macioce for her help in reading the manuscript and correcting English language.

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