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European Heart Journal 2001 22(11):942-954; doi:10.1053/euhj.2000.2419
Copyright © 2001 by the European Society of Cardiology.
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Continuous ambulatory monitoring of absolute right ventricular pressure and mixed venous oxygen saturation in patients with heart failure using an implantable haemodynamic monitor: results of a 1 year multicentre feasibility study

Å Ohlssona, S.H Kubob, D Steinhausc, D.T Connellyc, S Adlerb, C Bitkovera, R Nordlandera, L Rydéna,f1 and T Bennettd

a Karolinska Hospital, Stockholm, Sweden
b University of Minnesota, Minneapolis, Minnesota, U.S.A.
c Mid America Heart Institute, Kansas City, Missouri, U.S.A.
d Medtronic Incorporated, Minneapolis, Minnesota, U.S.A.

revised August 20, 2000; accepted August 23, 2000

Abstract

Background Implantable sensors that monitor haemodynamics over time may be useful in patients with heart failure. This multicentre study assessed the feasibility of a system that has one sensor measuring absolute pressure and another measuring mixed venous oxygen saturation (SvO2). Both sensors were mounted on leads that were implanted in the right ventricle.

Methods Twenty-one patients with heart failure (NYHA II-III) were included. Comparisons were made to right heart catheterizations at implant and at 2, 6 and 12 months thereafter. Patients underwent several haemodynamic provocations during the catheterizations.

Results Overall, among functioning sensors, the IHM-1 values were highly correlated with reference values for all time points during all provocations, demonstrating high reproducibility and stability (r2=0¶91, 0¶79 and 0¶78 for systolic, right ventricular diastolic and SvO2, respectively). Although IHM-1 underestimated reference pressure values by 4¶5mmHg and SvO2by 1¶6%, this difference was consistent across provocation and stable over 12 months of follow-up. Twelve of the 21 oxygen sensors failed to function and two pressure sensors had component failures. Preliminary analysis of long-term data revealed haemodynamic patterns that may be key indicators for therapeutic interventions.

Conclusion This multicentre feasibility study demonstrated the accuracy and stability of sensors implanted in the right ventricle. The IHM-1, using right ventricular pressures and SvO2, with improved performance, might be useful in the study of pathophysiological mechanisms and treatment interventions in heart failure.

Key Words: Heart failure, haemodynamics, ventricles, pressure oxygen

f1 Correspondence: Lars Rydén, MD, FESC, Department of Cardiology, Karolinska Hospital, 171 76 Stockholm, Sweden.


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