Background Ambulatory blood pressure monitoring (ABPM) using cuff-based devices is used for diagnosis and treatment of hypertension. Technical limitations, low compliance and complex procedures limit their use. The aim of the present study was to test the accuracy of a new photoplethysmography (PPG)-based, wearable device (Wrist-monitor) as compared to the standard cuff-based ABPM device. Methods 24H ABPM was performed in parallel for both devices on volunteers aged 18-65 years, while documenting their daily activities. Level of comfort and activity disturbance of both devices were recorded. Linear regression and Bland-Altman were used to evaluate the agreement between devices. Receiver Operating Characteristic (ROC) curve analysis was used to classify hypertension based on the average Wrist-monitor measurements as compared to a cuff-based ABPM device. Results The study included 28 subjects (18 men) mean age 41.5±16.2 years. Bland-Altman analysis resulted in 24H bias of -1.1 mmHg for both diastolic blood pressure (DBP) and systolic blood pressure (SBP). Mean daytime bias was -1.9 mmHg for DBP and SBP, while nighttime bias was smaller (0.7 and 0.4 mmHg for DBP and SBP respectively). ROC curve analysis yielded a mean area under the curve (AUC) of 1 for SBP and 24H BP measurements. AUCs of 0.994 and 0.955 were found for the daytime DBP and night DBP, respectively. 24H ABPM with the Wrist-monitor caused significantly less inconvenience compared to the cuff-based device (p<0.001). Conclusions The cuff-less device provides comparable measurements to those obtained with the currently used cuff-based ABPM device, with significantly less inconvenience to the subject.
Aims Papaverine is indicated for abdominal pain of various aetiologies. However, data on maternal and foetal safety following gestational exposure are lacking. The aim was to examine whether first trimester exposure to papaverine is associated with increased risk for major malformation and whether gestational exposure at any stage is associated with increased risk for preterm delivery, lower birthweight, small for gestational age, caesarean section (CS), lower Apgar score and perinatal death. Methods A retrospective comparative study consisted of pregnant women treated with papaverine between February 2010 and October 2019 at a large tertiary center. The control group comprised of livebirth deliveries randomly selected from the institutional obstetric database. Results The study group consisted of 498 pregnancies, which resulted in 537/544 (98.7%) live births, of whom 46/537 (8.6%) were exposed during the first trimester. The control group consisted of 498 pregnancies and 514 live births. Rate of major malformations did not differ between study group (2/46, 4.3%) and control (25/315, 4.9%, P = .67). Papaverine exposure was associated with higher rate of preterm delivery (22.3 vs. 10.3%, P < .001), CS (35.9 vs. 24.1%, P < .001) and lower birth weight (3207 vs. 3246 g, P = .02). Adjustment for treatment indication demonstrated that these remained significant only when given for obstetrical/surgical aetiologies. Comparable rates were observed for the remaining outcomes. Conclusions Short‐term gestational exposure to papaverine adjusted for indication was not associated with preterm deliveries, CS, lower birthweight, small for gestational age or perinatal death. Rate of major malformations among 46 first trimester exposures was comparable to controls.
Objective: Ambulatory blood pressure monitoring (ABPM) using cuff-based devices is used for diagnosis and treatment of hypertension. Technical limitations, low compliance and complex procedure limit their use. The aim of the present study was to compare a new technique of 24H ABPM using a photoplethysmography (PPG)-based, wearable device to the standard cuff-based device. Design and method: In this prospective study, 24H ABPM was performed using a standard cuff-based device and the PPG-based device (Wrist-monitor) in parallel on volunteers aged 18–65 years, while documenting their daily activities. Level of comfort and activity disturbance of both devices were recorded. Linear regression and Bland-Altman were used to evaluate the agreement between the Wrist-monitor and Holter. Receiver Operating Characteristic (ROC) curve analysis was used to assess the ability of the Wrist-monitor to identify abnormal BP values. Results: The study included 28 subjects (18 men) mean age 41.5 ± 16.2 years. Bland-Altman analysis results in 24H bias of -1.1 mmHg for both diastolic blood pressure (DBP) and systolic blood pressure (SBP). Mean daytime bias was -1.9 mmHg for DBP and SBP, while nighttime bias was smaller (0.7 and 0.4 mmHg for DBP and SBP respectively). ROC curve analysis on all BP readings (n = 2381) yielded a mean area under the curve (AUC) for 24 hours of 0.965 for both SBP and DBP. 24H ABPM with the Wrist-monitor caused significantly less inconvenience compared to the Holter (p < 0.001). Conclusions: The cuff-less device provides comparable measurements to those obtained with the currently used ABPM device, with significantly less inconvenience to the subject.
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