Measurement inaccuracy reported via the Manufacturer and User Facility Device Experience database for an implantable pulmonary artery pressure sensor: recalibration direction and magnitude results

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2024Author:
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Wetterling Friedrich, Kittipibul Veraprapas, Fudim Marat, Measurement inaccuracy reported via the Manufacturer and User Facility Device Experience database for an implantable pulmonary artery pressure sensor: recalibration direction and magnitude results, European Heart Journal, European Society of Cardiology, London, 31 August 2024, 45, Supplement 2, 2024, 2Abstract:
INTRODUCTION: Remote monitoring using an implantable pulmonary artery pressure (PAP)
sensor (CardioMEMS HF system) in patients with heart failure (HF) has been consistently
shown to reduce HF hospitalizations [1]. The success of this approach relies on the accurate
measurement of diastolic PAP (dPAP) over time to allow early interventions such as diuretic
intensification [2]. However, it remains unclear how the measurement accuracy changes over
time after the initial calibration at the time of device implantation.
PURPOSE: This study aims to identify measurement inaccuracy events and to quantify the
magnitude and direction of required device recalibration for CardioMEMS devices as reported
in a large-scale regulatory device database.
METHODS: We used the publicly accessible Manufacturer and User Facility Device
Experience (MAUDE) data maintained by the US Food and Drug Administration (FDA). The
summary search was performed for the CardioMEMS pulmonary artery pressure sensor for
the entire product life cycle from January 2009 to February 2024 [3,4]. The entries related to
the measurement accuracy under ‘Device Problems’ categories were obtained. Tested
accuracy was reported to have been within ±10mmHg of a reference pressure measurement
throughout simulated use for 10 years [5]. Normal range for dPAP is ~8mmHg to 15mmHg [6].
RESULTS: A total of 2656 entries were obtained. Following categories were identified for the
reported entries: device sensing problem (N=999, 38%); incorrect measurement (N=1349,
52%); incorrect measurement, inappropriate waveform (N=279, 11%), and incorrect,
inadequate, or imprecise results or readings (N=29, 1%). After excluding 56 entries for missing
information, 2600 entries were included for the analysis. A total of 1676 (64%) entries reported
the need for recalibration of the CardioMEMS device. A mean PAP difference (defined as the
difference of the mean PAP reference value measured at the time of recalibration minus the
CardioMEMS reading obtained during the reference measurement) is shown in Figure 1.
Compared to the reference pressure values at the time of recalibration, 488 (29%) of
CardioMEMS readings were higher and 1188 (71%) were lower. The absolute recalibration
pressure difference was 14.5 ± 9.3 mmHg (mean ± standard deviation, range 0.02-59.3
mmHg). The recalibration by more than 10 mmHg was reported in 1040 (40%) entries.
CONCLUSIONS: Suspected measurement inaccuracy with CardioMEMS device is not
uncommon and often necessitate recalibration. Almost one-half (40%) of the recalibrations
required more than 10 mmHg correction. These results should inform clinicians to consider
recalibration along the course of CardioMEMS monitoring if there is discordance between
clinical assessment and the values from the device
Author's Homepage:
http://people.tcd.ie/wetterf
Author: Wetterling, Friedrich
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European Heart JournalEuropean Society of Cardiology
Type of material:
Conference PaperSeries/Report no:
45;Supplement 2;
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Next Generation Medical DevicesMetadata
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