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Impact and management of physiological calibration in spectral analysis of blood pressure variability.

ABSTRACT: Physiological calibration (Physiocal) improves the quality of continuous blood pressure (BP) signal from finger. However, the effects of Physiocal on spectral characteristics of systolic BP (SBP) variability are not well-known. We tested the hypothesis that the use of Physiocal may alter the results on SBP variability when compared with BP recording without Physiocal. Continuous BP was recorded simultaneously from fingers of both arms during 10-min standing by two Nexfin devices, one with (ON) and the other without (OFF) Physiocal (n = 19). Missing SBP values in ON signal were linearly interpolated over Physiocal sequences (ONinter). The OFF signal was analyzed without any corrections (OFFreference) and after linear interpolation of corresponding sequences when Physiocal appeared in the ON signal (OFFinter). Mean low frequency power of SBP oscillations (LFSBP, 0.04-0.15 Hz) did not differ between the OFFreference, OFFinter, and ONinter. However, LFSBP deviated more from OFFreference when analyzed from ONinter compared with the analysis from OFFinter [median (interquartile range): 14.7 (4.6-38.6) vs. 0.9 (0.5-1.8) %, p < 0.05]. In conclusion, the use of Physiocal had a significant effect on the spectral SBP variability that overwhelms the impact of linear interpolation of short data sequences. Therefore, caution is needed when comparing SBP variability between BP datasets acquired with and without Physiocal.

SUBMITTER: Kiviniemi AM

PROVIDER: S-EPMC4253737 | biostudies-literature | 2014

REPOSITORIES: biostudies-literature

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Impact and management of physiological calibration in spectral analysis of blood pressure variability.

Kiviniemi Antti M AM Hintsala Heidi H Hautala Arto J AJ Ikäheimo Tiina M TM Jaakkola Jouni J JJ Tiinanen Suvi S Seppänen Tapio T Tulppo Mikko P MP

Frontiers in physiology 20141203

Physiological calibration (Physiocal) improves the quality of continuous blood pressure (BP) signal from finger. However, the effects of Physiocal on spectral characteristics of systolic BP (SBP) variability are not well-known. We tested the hypothesis that the use of Physiocal may alter the results on SBP variability when compared with BP recording without Physiocal. Continuous BP was recorded simultaneously from fingers of both arms during 10-min standing by two Nexfin devices, one with (ON) a ...[more]

PMID: 25520670

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Project description:BackgroundClinical guidelines recommend monitoring of blood pressure at home using an automatic blood pressure device for the management of hypertension. Devices are not often calibrated against direct blood pressure measures, leaving health care providers and patients with less reliable information than is possible with current technology. Rigorous assessments of medical devices are necessary for establishing clinical utility.ObjectiveThe purpose of our study was 2-fold: (1) to assess the validity and perform iterative calibration of indirect blood pressure measurements by a noninvasive wrist cuff blood pressure device in direct comparison with simultaneously recorded peripheral and central intra-arterial blood pressure measurements and (2) to assess the validity of the measurements thereafter of the noninvasive wrist cuff blood pressure device in comparison with measurements by a noninvasive upper arm blood pressure device to the Canadian hypertension guidelines.MethodsThe cloud-based blood pressure algorithms for an oscillometric wrist cuff device were iteratively calibrated to direct pressure measures in 20 consented patient participants. We then assessed measurement validity of the device, using Bland-Altman analysis during routine cardiovascular catheterization.ResultsThe precalibrated absolute mean difference between direct intra-arterial to wrist cuff pressure measurements were 10.8 (SD 9.7) for systolic and 16.1 (SD 6.3) for diastolic. The postcalibrated absolute mean difference was 7.2 (SD 5.1) for systolic and 4.3 (SD 3.3) for diastolic pressures. This is an improvement in accuracy of 33% systolic and 73% diastolic with a 48% reduction in the variability for both measures. Furthermore, the wrist cuff device demonstrated similar sensitivity in measuring high blood pressure compared with the direct intra-arterial method. The device, when calibrated to direct aortic pressures, demonstrated the potential to reduce a treatment gap in high blood pressure measurements.ConclusionsThe systolic pressure measurements of the wrist cuff have been iteratively calibrated using gold standard central (ascending aortic) pressure. This improves the accuracy of the indirect measures and potentially reduces the treatment gap. Devices that undergo auscultatory (indirect) calibration for licensing can be greatly improved by additional iterative calibration via intra-arterial (direct) measures of blood pressure. Further clinical trials with repeated use of the device over time are needed to assess the reliability of the device in accordance with current and evolving guidelines for informed decision making in the management of hypertension.Trial registrationClinicalTrials.gov NCT03015363; https://clinicaltrials.gov/ct2/show/NCT03015363 (Archived by WebCite at http://www.webcitation.org/6xPZgseYS).

Project description:Objective To systematically review studies quantifying the associations of long term (clinic), mid-term (home), and short term (ambulatory) variability in blood pressure, independent of mean blood pressure, with cardiovascular disease events and mortality.Data sources Medline, Embase, Cinahl, and Web of Science, searched to 15 February 2016 for full text articles in English.Eligibility criteria for study selection Prospective cohort studies or clinical trials in adults, except those in patients receiving haemodialysis, where the condition may directly impact blood pressure variability. Standardised hazard ratios were extracted and, if there was little risk of confounding, combined using random effects meta-analysis in main analyses. Outcomes included all cause and cardiovascular disease mortality and cardiovascular disease events. Measures of variability included standard deviation, coefficient of variation, variation independent of mean, and average real variability, but not night dipping or day-night variation.Results 41 papers representing 19 observational cohort studies and 17 clinical trial cohorts, comprising 46 separate analyses were identified. Long term variability in blood pressure was studied in 24 papers, mid-term in four, and short-term in 15 (two studied both long term and short term variability). Results from 23 analyses were excluded from main analyses owing to high risks of confounding. Increased long term variability in systolic blood pressure was associated with risk of all cause mortality (hazard ratio 1.15, 95% confidence interval 1.09 to 1.22), cardiovascular disease mortality (1.18, 1.09 to 1.28), cardiovascular disease events (1.18, 1.07 to 1.30), coronary heart disease (1.10, 1.04 to 1.16), and stroke (1.15, 1.04 to 1.27). Increased mid-term and short term variability in daytime systolic blood pressure were also associated with all cause mortality (1.15, 1.06 to 1.26 and 1.10, 1.04 to 1.16, respectively).Conclusions Long term variability in blood pressure is associated with cardiovascular and mortality outcomes, over and above the effect of mean blood pressure. Associations are similar in magnitude to those of cholesterol measures with cardiovascular disease. Limited data for mid-term and short term variability showed similar associations. Future work should focus on the clinical implications of assessment of variability in blood pressure and avoid the common confounding pitfalls observed to date.Systematic review registration PROSPERO CRD42014015695.

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Impact and management of physiological calibration in spectral analysis of blood pressure variability.

Publications

Impact and management of physiological calibration in spectral analysis of blood pressure variability.

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