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Invasive hemodynamics and cardiac biomarkers to predict outcomes after percutaneous edge-to-edge mitral valve repair in patients with severe heart failure

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Abstract

Background

Percutaneous mitral valve repair (PMVR) via MitraClip implantation is a therapeutic option for high-risk or non-surgical candidates with severe mitral regurgitation (MR) and advanced stages of heart failure (HF). However, these patients have a high mortality despite PMVR, and predictors for outcomes are not well established. Here, we evaluated invasive hemodynamics, echocardiography parameters, and biomarkers to predict outcomes after PMVR in severe HF patients.

Methods

Patients with reduced ejection fraction (EF) and severe and moderate-to-severe MR undergoing PMVR at our centre between September 2009 and January 2016 were analysed retrospectively. Inclusion criteria were: left ventricular EF < 45%, preoperative right heart catheterization, successful MitraClip deployment (“technical success”), and follow-up for at least 1 year after the procedure. Data from preoperative right heart catheterization, echocardiography, and biomarkers were assessed. Primary endpoint was all-cause mortality at 1 year after PMVR. We performed univariate and multivariate Cox regression analyses and generated a risk score to predict outcomes.

Results

Of 174 patients with PMVR and severe HF, 79.9% had functional MR. Mean EF was 25% (17.2; 30.7) and advanced New York Heart Association functional class was prevalent (class II: 13%; class III: 70%; and class IV: 17%). The cumulative incidences of all-cause death were 6.9% and 17.8% at 30 days and 1 year, respectively. In the Cox multivariate model, high-sensitive troponin T [hsTnT; hazard ratio (HR) 1.01; confidence interval (CI) 1.01–1.02; p < 0.0001] and mixed venous O2-saturation (HR 0.92; CI 0.89–0.96; p < 0.0001) were found to significantly and independently predict outcomes. A simple risk score including these two parameters was sufficient to discriminate between low- and high-risk patients (HR 7.22; CI 3.4–15.5; p < 0.001).

Conclusion

In a cohort of patients with severe HF undergoing PMVR, patients with elevated hsTnT and reduced mixed venous O2-saturation carried the worst prognosis. A simple risk score including these two parameters may improve patient selection and outcomes after PMVR.

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Acknowledgements

We thank Tanja Proctor, M.Sc. (Institute for Medical Biometry and Medical informatics, University of Heidelberg, Heidelberg, Germany) for statistical advice and review.

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Author notes

  1. Michael M. Kreusser and Nicolas A. Geis contributed equally and should be considered as first authors.

Authors and Affiliations

  1. Division of Cardiology, Department of Internal Medicine III, University of Heidelberg, Im Neuenheimer Feld 410, 69120, Heidelberg, Germany

    Michael M. Kreusser, Nicolas A. Geis, Nicolas Berlin, Sebastian Greiner, Sven T. Pleger, Raffi Bekeredjian, Hugo A. Katus & Philip W. Raake

  2. DZHK (German Center for Cardiovascular Research), Partner Site Heidelberg/Mannheim, Heidelberg, Germany

    Michael M. Kreusser, Hugo A. Katus & Philip W. Raake

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  1. Michael M. Kreusser
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Correspondence to Michael M. Kreusser.

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Conflict of interest

S. T. P., R. B., and P. W. R. received speaker honoraria from Abbott Vascular. M. M. K., N. G., R. B., and P. W. R. are investigators in the RESHAPE-HF (A Randomized Study of the MitraClip Device in Heart Failure Patients With Clinically Significant Functional Mitral Regurgitation) study. S.P. received research grants from Abbott. All other authors have no conflicts of interest to disclose.

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392_2018_1365_MOESM1_ESM.pptx

Suppl. Table: Procedural data. All data were taken from the original documentation of the MitraClip procedure. Patients were separated in patients who survived the first year after the procedure (survivors) and patients who did not survive 1 year after MitraClip implantation (non-survivors). Data are given as median [25–75 percentiles] or in percent (%). Comparisons between survivors and non-survivors were performed using the Mann–Whitney test for quantitative variables and the Chi-square test for qualitative variables. *Bold text represents p values &#x003C;0.05. MR mitral regurgitation; MPG mean pressure gradient. #Study inclusion already required successful MitraClip procedure including successful device deployment. ##Absence of procedural mortality or stroke and proper placement and positioning of the device and freedom from unplanned surgical or interventional procedure related to the device or access procedure and continued intended safety and performance of the device including no evidence of structural or functional failure, no specific device-related technical failure issues and complications and reduction of MR to either optimal (trace or absent residual MR) or acceptable (residual MR reduced by at least one grade from baseline and to no more than moderate (2+) in severity) levels without significant mitral stenosis (postprocedural mean transmitral gradient ≤5 mmHg) and with no greater than mild (1+) paravalvular MR (and without associated hemolysis). ###Device success and absence of major device or procedure related serious adverse events. ####One patient with periprocedural necessity of an intra-aortal ballon pump. Definitions of technical, device, and procedural success according to the Mitral Valve Academic Research Consortium (MVARC) [35] (PPTX 43 KB)

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Kreusser, M.M., Geis, N.A., Berlin, N. et al. Invasive hemodynamics and cardiac biomarkers to predict outcomes after percutaneous edge-to-edge mitral valve repair in patients with severe heart failure. Clin Res Cardiol 108, 375–387 (2019). https://doi.org/10.1007/s00392-018-1365-5

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