Validity and reliability of a novel slow cuff-deflation system for noninvasive blood pressure monitoring in patients with continuous-flow left ventricular assist device

Circ Heart Fail. 2013 Sep 1;6(5):1005-12. doi: 10.1161/CIRCHEARTFAILURE.112.000186. Epub 2013 Jun 27.

Abstract

Background: Doppler ultrasound is the clinical gold standard for noninvasive blood pressure (BP) measurement among continuous-flow left ventricular assist device patients. The relationship of Doppler BP to systolic BP (SBP) and mean arterial pressure (MAP) is uncertain and Doppler measurements require a clinic visit. We studied the relationship between Doppler BP and both arterial-line (A-line) SBP and MAP. Validity and reliability of the Terumo Elemano BP Monitor, a novel slow cuff-deflation device that could potentially be used by patients at home, were assessed.

Methods and results: Doppler and Terumo BP measurements were made in triplicate among 60 axial continuous-flow left ventricular assist device (HeartMate II) patients (30 inpatients and 30 outpatients) at 2 separate exams (360 possible measurements). A-line measures were also obtained among inpatients. Mean absolute differences (MADs) and correlations were used to determine within-device reliability (comparison of second and third BP measures) and between-device validity. Bland-Altman plots assessed BP agreement between A-line, Doppler BP, and Terumo Elemano. Success rates for Doppler and Terumo Elemano were 100% and 91%. Terumo Elemano MAD for repeat SBP and MAP were 4.6±0.6 and 4.2±0.6 mm Hg; repeat Doppler BP MAD was 2.9±0.2 mm Hg. Mean Doppler BP was lower than A-line SBP by 4.1 (MAD=6.4±1.4) mm Hg and higher than MAP by 9.5 (MAD=11.0±1.2) mm Hg; Terumo Elemano underestimated A-line SBP by 0.3 (MAD=5.6±0.9) mm Hg and MAP by 1.7 (MAD=6.0±1.0) mm Hg.

Conclusions: Doppler BP more closely approximates SBP than MAP. Terumo Elemano was successful, reliable, and valid when compared with A-line and Doppler.

Keywords: Terumo Elemano; blood pressure measurement/monitoring; heart failure; heart-assist devices.

Publication types

  • Comparative Study
  • Research Support, Non-U.S. Gov't
  • Validation Study

MeSH terms

  • Aged
  • Analysis of Variance
  • Arterial Pressure*
  • Blood Pressure Determination / instrumentation*
  • Diastole
  • Equipment Design
  • Female
  • Heart Failure / diagnosis
  • Heart Failure / physiopathology
  • Heart Failure / therapy*
  • Heart-Assist Devices*
  • Humans
  • Linear Models
  • Logistic Models
  • Male
  • Middle Aged
  • Odds Ratio
  • Predictive Value of Tests
  • Prospective Studies
  • Reproducibility of Results
  • Sphygmomanometers*
  • Systole
  • Time Factors
  • Treatment Outcome
  • Ultrasonography, Doppler