Pub Date : 2024-12-01Epub Date: 2024-08-09DOI: 10.1097/MBP.0000000000000722
Chung-Yu Lin, I-Chih Huang
Objective: To determine the accuracy of the AViTA BP636 upper-arm home blood pressure (BP) monitor in general populations with small to extra-large arms according to the ANSI/AAMI/ISO Universal Standard (ISO 81060-2 : 2018/Amd1 : 2020).
Methods: The AViTA BPM636 was utilized on 85 adult participants with upper-arm circumferences ranging from 15 to 52 cm, and four cuffs of different sizes (small: 15-22 cm, normal: 22-33 cm, large: 33-42 cm, and extra large: 42-52 cm) were used in this study. The recruitment fulfills the criteria of the ANSI/AAMI/ISO Universal Standard 81060-2 : 2018/Amd1 : 2020 in the general population using the same arm sequential BP measurement method.
Results: For validation criterion 1, the mean ± SD of the differences between the test device and reference blood pressure readings was -0.35 ± 4.68/0.56 ± 3.93 mmHg (systolic/diastolic) for adults. The mean difference of SBP between the test device and the reference device was -0.35 mmHg with a SD of 3.50 mmHg, which was within the acceptable range for criterion 2 (i.e. less than 6.93 mmHg) Similarly, the mean difference in DBP was 0.56 mmHg with a SD of 3.38 mmHg, which also met the criterion 2 (i.e. within 6.91 mmHg).
Conclusion: AViTA BPM636 passed the criteria of the ANSI/AAMI/ISO 81060-2 : 2018/Amd 1 : 2020 protocol. It can be recommended for home-based BP measurements in the general population and people with extra-large arms ranging from 42 to 52 cm.
{"title":"Validation of the AViTA upper-arm blood pressure monitor BP636 with multiple cuff sizes in the general population according to the ANSI/AAMI/ISO 81060-2:2018/Amd1:2020.","authors":"Chung-Yu Lin, I-Chih Huang","doi":"10.1097/MBP.0000000000000722","DOIUrl":"10.1097/MBP.0000000000000722","url":null,"abstract":"<p><strong>Objective: </strong>To determine the accuracy of the AViTA BP636 upper-arm home blood pressure (BP) monitor in general populations with small to extra-large arms according to the ANSI/AAMI/ISO Universal Standard (ISO 81060-2 : 2018/Amd1 : 2020).</p><p><strong>Methods: </strong>The AViTA BPM636 was utilized on 85 adult participants with upper-arm circumferences ranging from 15 to 52 cm, and four cuffs of different sizes (small: 15-22 cm, normal: 22-33 cm, large: 33-42 cm, and extra large: 42-52 cm) were used in this study. The recruitment fulfills the criteria of the ANSI/AAMI/ISO Universal Standard 81060-2 : 2018/Amd1 : 2020 in the general population using the same arm sequential BP measurement method.</p><p><strong>Results: </strong>For validation criterion 1, the mean ± SD of the differences between the test device and reference blood pressure readings was -0.35 ± 4.68/0.56 ± 3.93 mmHg (systolic/diastolic) for adults. The mean difference of SBP between the test device and the reference device was -0.35 mmHg with a SD of 3.50 mmHg, which was within the acceptable range for criterion 2 (i.e. less than 6.93 mmHg) Similarly, the mean difference in DBP was 0.56 mmHg with a SD of 3.38 mmHg, which also met the criterion 2 (i.e. within 6.91 mmHg).</p><p><strong>Conclusion: </strong>AViTA BPM636 passed the criteria of the ANSI/AAMI/ISO 81060-2 : 2018/Amd 1 : 2020 protocol. It can be recommended for home-based BP measurements in the general population and people with extra-large arms ranging from 42 to 52 cm.</p>","PeriodicalId":8950,"journal":{"name":"Blood Pressure Monitoring","volume":" ","pages":"321-326"},"PeriodicalIF":1.2,"publicationDate":"2024-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11524622/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141916057","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-12-01Epub Date: 2024-07-16DOI: 10.1097/MBP.0000000000000716
Yuehong Jin, Xiaoming Bei, Ying Jin
Objective: Evaluation of the accuracy of the wrist-type fully automatic blood pressure (BP) monitor: DBP-2242 in adolescent and adult populations according to ISO 81060-2 : 2018+Amd.1 : 2020.
Methods: BP measurements were taken from the subjects using the same-arm sequential method, and BP data measured by a mercury sphygmomanometer was used as the standard.
Results: This study analyzed 262 sets of data from 89 subjects. According to criterion 1, the mean difference between the SBP of the test and reference devices was -0.57 ± 7.31 mmHg, and the DBP was -2.27 ± 7.17 mmHg, which is in accordance with the requirements. According to criterion 2, the average difference between the SBP was -0.57 ± 6.25 mmHg and the DBP was -2.27 ± 5.99 mmHg, which is in accordance with the requirements.
Conclusion: Wrist-type fully automatic BP monitor: DBP-2242 complies with ISO 81060-2 : 2018+Amd.1 : 2020 and can be used for BP measurement in adolescent and adult populations.
{"title":"Validation of the validity of the new wrist-type fully automatic blood pressure monitor: DBP-2242 according to ISO 81060-2:2018+AMD 1:2020.","authors":"Yuehong Jin, Xiaoming Bei, Ying Jin","doi":"10.1097/MBP.0000000000000716","DOIUrl":"10.1097/MBP.0000000000000716","url":null,"abstract":"<p><strong>Objective: </strong>Evaluation of the accuracy of the wrist-type fully automatic blood pressure (BP) monitor: DBP-2242 in adolescent and adult populations according to ISO 81060-2 : 2018+Amd.1 : 2020.</p><p><strong>Methods: </strong>BP measurements were taken from the subjects using the same-arm sequential method, and BP data measured by a mercury sphygmomanometer was used as the standard.</p><p><strong>Results: </strong>This study analyzed 262 sets of data from 89 subjects. According to criterion 1, the mean difference between the SBP of the test and reference devices was -0.57 ± 7.31 mmHg, and the DBP was -2.27 ± 7.17 mmHg, which is in accordance with the requirements. According to criterion 2, the average difference between the SBP was -0.57 ± 6.25 mmHg and the DBP was -2.27 ± 5.99 mmHg, which is in accordance with the requirements.</p><p><strong>Conclusion: </strong>Wrist-type fully automatic BP monitor: DBP-2242 complies with ISO 81060-2 : 2018+Amd.1 : 2020 and can be used for BP measurement in adolescent and adult populations.</p>","PeriodicalId":8950,"journal":{"name":"Blood Pressure Monitoring","volume":" ","pages":"317-320"},"PeriodicalIF":1.2,"publicationDate":"2024-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11524616/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141619223","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-12-01Epub Date: 2024-08-20DOI: 10.1097/MBP.0000000000000723
Fu-Chun Chiu, I-Chih Huang
Background: Atrial fibrillation (AF) is a stroke and heart complication risk but is often overlooked due to subtle symptoms. The accessibility of sphygmomanometers that can detect AF, may play crucial roles in identifying asymptomatic patients. AViTA BPM63B is an automatic blood pressure (BP) monitor for atrial fibrillation detection. This study validated the performance of BPM63B for AF detection using two novel algorithms of time-domain analysis and frequency-domain analysis which evaluate multiple statistics.
Methods: The study included 100 participants, with 47 participants being male (47%) and ages ranging from 24 to 89 years (mean ± SD: 59 ± 17 years). Each participant received three consecutive readings from the subject device and a 12-lead ECG assessment. The pulse wave data from subject device was analyzed using the two algorithms. The atrial fibrillation status thus determined was compared to the ECG results interpreted by a physician.
Results: Among the 100 participants, 52 patients had chronic atrial fibrillation, along with 48 outpatients exhibiting sinus rhythm or non-atrial fibrillation arrhythmias. Using the time-domain analysis method for atrial fibrillation detection, we achieved a sensitivity of 94.8% [95% confidence interval (CI), 90.08-97.75%] and a specificity of 98.6% (95% CI, 95.07-99.83%). Similarly, utilizing the frequency-domain analysis method resulted in a sensitivity of 91.6% (95% CI, 86.08-95.46%) and specificity of 94.4% (95% CI, 89.35-97.57%).
Conclusions: These findings suggest that AViTA BPM63B, which integrates two novel algorithms for atrial fibrillation diagnosis, demonstrates high sensitivity and specificity. Utilizing the AViTA BPM63B for BP monitoring could aid in the early detection of atrial fibrillation among outpatients in cardiology clinics.
{"title":"A clinical validation of AViTA home blood pressure monitor for atrial fibrillation detection in adults.","authors":"Fu-Chun Chiu, I-Chih Huang","doi":"10.1097/MBP.0000000000000723","DOIUrl":"10.1097/MBP.0000000000000723","url":null,"abstract":"<p><strong>Background: </strong>Atrial fibrillation (AF) is a stroke and heart complication risk but is often overlooked due to subtle symptoms. The accessibility of sphygmomanometers that can detect AF, may play crucial roles in identifying asymptomatic patients. AViTA BPM63B is an automatic blood pressure (BP) monitor for atrial fibrillation detection. This study validated the performance of BPM63B for AF detection using two novel algorithms of time-domain analysis and frequency-domain analysis which evaluate multiple statistics.</p><p><strong>Methods: </strong>The study included 100 participants, with 47 participants being male (47%) and ages ranging from 24 to 89 years (mean ± SD: 59 ± 17 years). Each participant received three consecutive readings from the subject device and a 12-lead ECG assessment. The pulse wave data from subject device was analyzed using the two algorithms. The atrial fibrillation status thus determined was compared to the ECG results interpreted by a physician.</p><p><strong>Results: </strong>Among the 100 participants, 52 patients had chronic atrial fibrillation, along with 48 outpatients exhibiting sinus rhythm or non-atrial fibrillation arrhythmias. Using the time-domain analysis method for atrial fibrillation detection, we achieved a sensitivity of 94.8% [95% confidence interval (CI), 90.08-97.75%] and a specificity of 98.6% (95% CI, 95.07-99.83%). Similarly, utilizing the frequency-domain analysis method resulted in a sensitivity of 91.6% (95% CI, 86.08-95.46%) and specificity of 94.4% (95% CI, 89.35-97.57%).</p><p><strong>Conclusions: </strong>These findings suggest that AViTA BPM63B, which integrates two novel algorithms for atrial fibrillation diagnosis, demonstrates high sensitivity and specificity. Utilizing the AViTA BPM63B for BP monitoring could aid in the early detection of atrial fibrillation among outpatients in cardiology clinics.</p>","PeriodicalId":8950,"journal":{"name":"Blood Pressure Monitoring","volume":" ","pages":"299-304"},"PeriodicalIF":1.2,"publicationDate":"2024-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11524633/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142016286","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Objective: Since hyperuricemia is a risk factor for cardiovascular disease and chronic kidney disease, it is necessary to pay attention to trends in uric acid levels when treating hypertensive patients with drugs. The present study investigated the effect of switching from angiotensin II receptor blocker (ARB) to sacubitril/valsartan on serum uric acid levels in treated hypertensive patients and further examined what factors could be associated with its effect.
Methods: In 75 hypertensive patients under treatment with at least one antihypertensive agent including ARB, clinic blood pressure and biochemical parameters were assessed before and after drug switching to sacubitril/valsartan (200 mg/day).
Results: Clinic SBP and DBP significantly decreased after drug switching to sacubitril/valsartan ( P < 0.0001, respectively). Serum creatinine, estimated glomerular filtration rate (eGFR), and urinary protein did not change after switching to sacubitril/valsartan, but serum uric acid significantly decreased (5.70 ± 1.44 to 5.40 ± 1.43 mg/dl, P = 0.0017). The degree of uric acid lowering was greater in patients switching from ARB plus diuretic than in those switching from ARB, but switching to sacubitril/valsartan from ARB only (except losartan) also significantly decreased uric acid levels. In all subjects, the change in serum uric acid after drug switching to sacubitril/valsartan was closely correlated with the change in eGFR ( r = -0.5264, P < 0.0001).
Conclusion: Our findings indicate that switching from ARB to sacubitril/valsartan reduces serum uric acid levels in hypertensive patients and suggest that this uric acid-lowering effect may be associated with an increase in eGFR.
{"title":"Serum uric acid-lowering effect of sacubitril/valsartan in hypertensive patients: evaluation by switching from angiotensin II receptor blockers.","authors":"Takeshi Horio, Yoshio Iwashima, Minoru Yoshiyama, Daiju Fukuda, Takamasa Hasegawa, Kohei Fujimoto","doi":"10.1097/MBP.0000000000000725","DOIUrl":"10.1097/MBP.0000000000000725","url":null,"abstract":"<p><strong>Objective: </strong>Since hyperuricemia is a risk factor for cardiovascular disease and chronic kidney disease, it is necessary to pay attention to trends in uric acid levels when treating hypertensive patients with drugs. The present study investigated the effect of switching from angiotensin II receptor blocker (ARB) to sacubitril/valsartan on serum uric acid levels in treated hypertensive patients and further examined what factors could be associated with its effect.</p><p><strong>Methods: </strong>In 75 hypertensive patients under treatment with at least one antihypertensive agent including ARB, clinic blood pressure and biochemical parameters were assessed before and after drug switching to sacubitril/valsartan (200 mg/day).</p><p><strong>Results: </strong>Clinic SBP and DBP significantly decreased after drug switching to sacubitril/valsartan ( P < 0.0001, respectively). Serum creatinine, estimated glomerular filtration rate (eGFR), and urinary protein did not change after switching to sacubitril/valsartan, but serum uric acid significantly decreased (5.70 ± 1.44 to 5.40 ± 1.43 mg/dl, P = 0.0017). The degree of uric acid lowering was greater in patients switching from ARB plus diuretic than in those switching from ARB, but switching to sacubitril/valsartan from ARB only (except losartan) also significantly decreased uric acid levels. In all subjects, the change in serum uric acid after drug switching to sacubitril/valsartan was closely correlated with the change in eGFR ( r = -0.5264, P < 0.0001).</p><p><strong>Conclusion: </strong>Our findings indicate that switching from ARB to sacubitril/valsartan reduces serum uric acid levels in hypertensive patients and suggest that this uric acid-lowering effect may be associated with an increase in eGFR.</p>","PeriodicalId":8950,"journal":{"name":"Blood Pressure Monitoring","volume":" ","pages":"305-311"},"PeriodicalIF":1.2,"publicationDate":"2024-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142340991","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-11-26DOI: 10.1097/MBP.0000000000000736
Jia-Hui Xia, Yi-Bang Cheng, Ting-Yan Xu, Qian-Hui Guo, Chak-Ming Chan, Lei-Xiao Hu, Yan Li, Ji-Guang Wang
Objective: The objective of this study was to investigate the efficacy of the nitrendipine/atenolol combination in comparison with standard-dose nitrendipine or atenolol monotherapy in reducing blood pressure (BP) and blood pressure variability (BPV) as assessed by ambulatory BP monitoring.
Methods: In a randomized, crossover trial, 32 patients (30-65 years) with grade 1 hypertension and elevated daytime reading-to-reading BPV were randomly assigned to receive either the nitrendipine/atenolol combination (10/20 mg) or standard-dose nitrendipine (10 mg) or atenolol (25 mg) monotherapy for 6 weeks, followed by a crossover to another treatment for 6 weeks.
Results: The final analysis included 31 patients (mean [±SD] age, 49.2 ± 9.6 years) and 12 men. The nitrendipine/atenolol combination significantly reduced from baseline clinic and ambulatory BP and pulse rate (P ≤ 0.002), and 24 h and daytime systolic and diastolic BPV as assessed by SD and average real variability (P ≤ 0.042), but not the coefficient of variation nor nighttime BPV indices (P ≥ 0.06). Significant differences between the nitrendipine/atenolol combination and nitrendipine or atenolol monotherapy at the end of treatment were observed in clinic BP and pulse rate (P ≤ 0.042), but not in 24 h, daytime and nighttime blood pressure and pulse rate, except for daytime DBP and 24 h and daytime pulse rate (P ≤ 0.049). There were no significant differences in BPV between the combination and monotherpy groups at the end of treatment (P ≥ 0.25).
Conclusion: The nitrendipine/atenolol combination reduced daytime reading-to-reading BPV, but did not show superiority to nitrendipine or atenolol monotherapy.
{"title":"Effect of a calcium-channel blocker and β-blocker combination on reading-to-reading blood pressure variability: a randomized crossover trial.","authors":"Jia-Hui Xia, Yi-Bang Cheng, Ting-Yan Xu, Qian-Hui Guo, Chak-Ming Chan, Lei-Xiao Hu, Yan Li, Ji-Guang Wang","doi":"10.1097/MBP.0000000000000736","DOIUrl":"https://doi.org/10.1097/MBP.0000000000000736","url":null,"abstract":"<p><strong>Objective: </strong>The objective of this study was to investigate the efficacy of the nitrendipine/atenolol combination in comparison with standard-dose nitrendipine or atenolol monotherapy in reducing blood pressure (BP) and blood pressure variability (BPV) as assessed by ambulatory BP monitoring.</p><p><strong>Methods: </strong>In a randomized, crossover trial, 32 patients (30-65 years) with grade 1 hypertension and elevated daytime reading-to-reading BPV were randomly assigned to receive either the nitrendipine/atenolol combination (10/20 mg) or standard-dose nitrendipine (10 mg) or atenolol (25 mg) monotherapy for 6 weeks, followed by a crossover to another treatment for 6 weeks.</p><p><strong>Results: </strong>The final analysis included 31 patients (mean [±SD] age, 49.2 ± 9.6 years) and 12 men. The nitrendipine/atenolol combination significantly reduced from baseline clinic and ambulatory BP and pulse rate (P ≤ 0.002), and 24 h and daytime systolic and diastolic BPV as assessed by SD and average real variability (P ≤ 0.042), but not the coefficient of variation nor nighttime BPV indices (P ≥ 0.06). Significant differences between the nitrendipine/atenolol combination and nitrendipine or atenolol monotherapy at the end of treatment were observed in clinic BP and pulse rate (P ≤ 0.042), but not in 24 h, daytime and nighttime blood pressure and pulse rate, except for daytime DBP and 24 h and daytime pulse rate (P ≤ 0.049). There were no significant differences in BPV between the combination and monotherpy groups at the end of treatment (P ≥ 0.25).</p><p><strong>Conclusion: </strong>The nitrendipine/atenolol combination reduced daytime reading-to-reading BPV, but did not show superiority to nitrendipine or atenolol monotherapy.</p>","PeriodicalId":8950,"journal":{"name":"Blood Pressure Monitoring","volume":" ","pages":""},"PeriodicalIF":1.2,"publicationDate":"2024-11-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142999312","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-11-14DOI: 10.1097/MBP.0000000000000734
Sebastiano Cicco, Marialuisa Sveva Marozzi, Gabriella Schirosi, Francesco Corvasce, Daniele Egidio Romano, Angelo Vacca, Pietro Nazzaro
Background and objective: Ambulatory blood pressure monitoring (ABPM) requires automatic measurement and the use of a validated device, according to current guidelines and international standardization. The TM-2441 (A&D Co. Ltd, Tokyo, Japan) ABPM device is small, lightweight, and suitable for use in ambulatory settings. It was validated against the ISO 81060-2:2013 standard in the general population. This study investigated the reliability of the ABPM device for patients with type 2 diabetes.
Methods: Individuals aged more than 12 years affected with type 2 diabetes were recruited by our outpatient clinic. The blood pressure assessment was performed using the opposite limb simultaneous measurement according to the updated ISO 81060-2:2018.
Results: Forty-five subjects were included in the clinical investigation. The mean difference between blood pressure values measured by the TM-2441 ABPM device and the reference sphygmomanometer was within limits allowed by the ISO standard. Bland-Altman plots of the measurements and differences between the values obtained from the study device and those from the reference device showed no systematic variations in error. It was not possible to perform a stress test in most patients due to refusal or poor physical condition.
Conclusion: The TM-2441 ABPM device fulfilled all the requirements of the ISO standard for ambulatory testing not only in a general population but also in the subgroup of subjects with type 2 diabetes.
背景和目的:非卧床血压监测 (ABPM) 需要根据现行指南和国际标准化要求进行自动测量并使用经过验证的设备。TM-2441(A&D 有限公司,日本东京)非卧床血压监测设备体积小、重量轻,适合在非卧床环境中使用。该设备根据 ISO 81060-2:2013 标准在普通人群中进行了验证。本研究调查了 ABPM 设备对 2 型糖尿病患者的可靠性:方法:我们的门诊部招募了年龄超过 12 岁的 2 型糖尿病患者。根据最新的 ISO 81060-2:2018,使用对侧肢体同时测量法进行血压评估:45名受试者参与了临床调查。TM-2441 ABPM 设备和参考血压计测量的血压值之间的平均差在 ISO 标准允许的范围内。研究设备和参照设备测量值之间的测量值和差值的 Bland-Altman 图显示,误差没有系统性变化。由于大多数患者拒绝或身体状况差,无法进行压力测试:结论:TM-2441 ABPM 设备不仅在普通人群中,而且在 2 型糖尿病患者亚群中,都能满足 ISO 标准对非卧床测试的所有要求。
{"title":"Efficient use of the TM-2441 ambulatory blood pressure measurement device in patients with diabetes.","authors":"Sebastiano Cicco, Marialuisa Sveva Marozzi, Gabriella Schirosi, Francesco Corvasce, Daniele Egidio Romano, Angelo Vacca, Pietro Nazzaro","doi":"10.1097/MBP.0000000000000734","DOIUrl":"https://doi.org/10.1097/MBP.0000000000000734","url":null,"abstract":"<p><strong>Background and objective: </strong>Ambulatory blood pressure monitoring (ABPM) requires automatic measurement and the use of a validated device, according to current guidelines and international standardization. The TM-2441 (A&D Co. Ltd, Tokyo, Japan) ABPM device is small, lightweight, and suitable for use in ambulatory settings. It was validated against the ISO 81060-2:2013 standard in the general population. This study investigated the reliability of the ABPM device for patients with type 2 diabetes.</p><p><strong>Methods: </strong>Individuals aged more than 12 years affected with type 2 diabetes were recruited by our outpatient clinic. The blood pressure assessment was performed using the opposite limb simultaneous measurement according to the updated ISO 81060-2:2018.</p><p><strong>Results: </strong>Forty-five subjects were included in the clinical investigation. The mean difference between blood pressure values measured by the TM-2441 ABPM device and the reference sphygmomanometer was within limits allowed by the ISO standard. Bland-Altman plots of the measurements and differences between the values obtained from the study device and those from the reference device showed no systematic variations in error. It was not possible to perform a stress test in most patients due to refusal or poor physical condition.</p><p><strong>Conclusion: </strong>The TM-2441 ABPM device fulfilled all the requirements of the ISO standard for ambulatory testing not only in a general population but also in the subgroup of subjects with type 2 diabetes.</p>","PeriodicalId":8950,"journal":{"name":"Blood Pressure Monitoring","volume":" ","pages":""},"PeriodicalIF":1.2,"publicationDate":"2024-11-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142680713","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-11-14DOI: 10.1097/MBP.0000000000000735
Hao Chen
This study evaluated the accuracy of blood pressure measurement in adults using FF680 electronic blood pressure monitors with the Korotkoff-Sound method, in accordance with the ISO 81060-2:2018. The study was conducted at Shijiazhuang People's Hospital and lasted 56 days, from 26 May to 21 July 2023. Participants, drawn from an adult demographic, underwent data verification and analysis with strict adherence to the trial protocol. For the FF680 electronic blood pressure monitor using the Korotkoff-Sound method, data from 85 valid participants were analyzed. The findings revealed mean differences (SDs) of -0.66 mmHg (2.45 mmHg) for SBP and -0.28 mmHg (2.09 mmHg) for DBP. SBP and DBP had SDs of ≤6.9 and ≤6.95 mmHg, meeting the standard requirements. FF680 devices are recommended for adult blood pressure monitoring because they meet the ISO 81060-2:2018.
{"title":"Validation of the FF680 upper-arm blood pressure monitor according to the ISO 81060-2:2018.","authors":"Hao Chen","doi":"10.1097/MBP.0000000000000735","DOIUrl":"10.1097/MBP.0000000000000735","url":null,"abstract":"<p><p>This study evaluated the accuracy of blood pressure measurement in adults using FF680 electronic blood pressure monitors with the Korotkoff-Sound method, in accordance with the ISO 81060-2:2018. The study was conducted at Shijiazhuang People's Hospital and lasted 56 days, from 26 May to 21 July 2023. Participants, drawn from an adult demographic, underwent data verification and analysis with strict adherence to the trial protocol. For the FF680 electronic blood pressure monitor using the Korotkoff-Sound method, data from 85 valid participants were analyzed. The findings revealed mean differences (SDs) of -0.66 mmHg (2.45 mmHg) for SBP and -0.28 mmHg (2.09 mmHg) for DBP. SBP and DBP had SDs of ≤6.9 and ≤6.95 mmHg, meeting the standard requirements. FF680 devices are recommended for adult blood pressure monitoring because they meet the ISO 81060-2:2018.</p>","PeriodicalId":8950,"journal":{"name":"Blood Pressure Monitoring","volume":" ","pages":""},"PeriodicalIF":1.2,"publicationDate":"2024-11-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142680715","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-11-08DOI: 10.1097/MBP.0000000000000733
Luiz Filipe Costa Chaves, Bruno Bavaresco Gambassi, Eduardo Cadore, Samir Sotão, Thiago Matheus Sousa, Danielle da Silva Dias, Paulo Adriano Schwingel, Cristiano Mostarda
Objective: This study aimed to investigate the effects of power training (PT) using elastic bands combined with endurance training (ET) on pulse pressure (PP), systolic (SBP) and diastolic blood pressures (DBP), autonomic response (AR), and functional parameters in older adults.
Methods: Thirty participants were randomly assigned to the control group (n = 15) and the intervention group (IG) (n = 15). IG participants performed PT with elastic bands combined with ET twice weekly for 8 weeks. PP, SBP, DBP, AR, and functional parameters were assessed before and after 8 weeks.
Results: PP, SBP, and functional parameters significantly improved after 8 weeks in the IG (P < 0.05). The study also found a clinically significant reduction in the SBP (Δ = -16.5 mmHg; η2p = 0.36) and DBP (Δ = -4.3 mmHg; η2p = 0.26), and a clinical reduction in the 5-Repetition Sit-To-Stand test (η2p = 0.63) and the elbow flexion test (η2p = 0.51).
Conclusion: Our findings indicate that PT with elastic bands combined with ET improves PP, SBP, and functional parameters in older adults. Hence, our combined training protocol can be an easily accessible, low-cost, nonpharmacological strategy for strength, and conditioning professionals to prescribe as an exercise intervention to older adults.
{"title":"Power exercises with elastic bands combined with endurance training improve pulse pressure, systolic blood pressure, and functional parameters in older adults.","authors":"Luiz Filipe Costa Chaves, Bruno Bavaresco Gambassi, Eduardo Cadore, Samir Sotão, Thiago Matheus Sousa, Danielle da Silva Dias, Paulo Adriano Schwingel, Cristiano Mostarda","doi":"10.1097/MBP.0000000000000733","DOIUrl":"https://doi.org/10.1097/MBP.0000000000000733","url":null,"abstract":"<p><strong>Objective: </strong>This study aimed to investigate the effects of power training (PT) using elastic bands combined with endurance training (ET) on pulse pressure (PP), systolic (SBP) and diastolic blood pressures (DBP), autonomic response (AR), and functional parameters in older adults.</p><p><strong>Methods: </strong>Thirty participants were randomly assigned to the control group (n = 15) and the intervention group (IG) (n = 15). IG participants performed PT with elastic bands combined with ET twice weekly for 8 weeks. PP, SBP, DBP, AR, and functional parameters were assessed before and after 8 weeks.</p><p><strong>Results: </strong>PP, SBP, and functional parameters significantly improved after 8 weeks in the IG (P < 0.05). The study also found a clinically significant reduction in the SBP (Δ = -16.5 mmHg; η2p = 0.36) and DBP (Δ = -4.3 mmHg; η2p = 0.26), and a clinical reduction in the 5-Repetition Sit-To-Stand test (η2p = 0.63) and the elbow flexion test (η2p = 0.51).</p><p><strong>Conclusion: </strong>Our findings indicate that PT with elastic bands combined with ET improves PP, SBP, and functional parameters in older adults. Hence, our combined training protocol can be an easily accessible, low-cost, nonpharmacological strategy for strength, and conditioning professionals to prescribe as an exercise intervention to older adults.</p>","PeriodicalId":8950,"journal":{"name":"Blood Pressure Monitoring","volume":" ","pages":""},"PeriodicalIF":1.2,"publicationDate":"2024-11-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142680714","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-10-16DOI: 10.1097/MBP.0000000000000731
Ilargi Gorostegi-Anduaga, Mikel Tous-Espelosin, Sara Maldonado-Martín
Cardiovascular events are positively associated with primary hypertension (HTN), obesity, and low cardiorespiratory fitness (CRF) and negatively with healthy dietary patterns, such as Healthy Diet Indicator (HDI), Mediterranean diet (MD), and the Dietary Approaches to Stop Hypertension (DASH). The aim is to analyze the association between healthy dietary patterns with body composition and CRF. Body composition (bioimpedance) and CRF [peak oxygen uptake (V̇O2peak)] were assessed in 165 participants with HTN and overweight/obesity. There were (1) a positive association (unadjusted) between fat-free mass (%) with DASH and MD (P = 0.03) and a negative association between fat mass (%) and MD (P = 0.03); (2) positive associations (adjusted) between V̇O2peak (l·min-1) with DASH (P = 0.007), HDI (P = 0.017), and MD (P = 0.010) and V̇O2peak (ml·kg-1·min-1) with DASH (P = 0.005); (3) a negative relationship (unadjusted and adjusted) between energy intake and DASH (P = 0.004). In conclusion, these findings highlight the cardiovascular health protection provided by healthy dietary patterns associated with healthier CRF and body composition in people with a profile of HTN and overweight.
{"title":"Does greater adherence to a healthy dietary pattern correspond to a better body composition and cardiorespiratory fitness in adults with overweight and primary hypertension? Data from the EXERDIET-HTA study.","authors":"Ilargi Gorostegi-Anduaga, Mikel Tous-Espelosin, Sara Maldonado-Martín","doi":"10.1097/MBP.0000000000000731","DOIUrl":"https://doi.org/10.1097/MBP.0000000000000731","url":null,"abstract":"<p><p>Cardiovascular events are positively associated with primary hypertension (HTN), obesity, and low cardiorespiratory fitness (CRF) and negatively with healthy dietary patterns, such as Healthy Diet Indicator (HDI), Mediterranean diet (MD), and the Dietary Approaches to Stop Hypertension (DASH). The aim is to analyze the association between healthy dietary patterns with body composition and CRF. Body composition (bioimpedance) and CRF [peak oxygen uptake (V̇O2peak)] were assessed in 165 participants with HTN and overweight/obesity. There were (1) a positive association (unadjusted) between fat-free mass (%) with DASH and MD (P = 0.03) and a negative association between fat mass (%) and MD (P = 0.03); (2) positive associations (adjusted) between V̇O2peak (l·min-1) with DASH (P = 0.007), HDI (P = 0.017), and MD (P = 0.010) and V̇O2peak (ml·kg-1·min-1) with DASH (P = 0.005); (3) a negative relationship (unadjusted and adjusted) between energy intake and DASH (P = 0.004). In conclusion, these findings highlight the cardiovascular health protection provided by healthy dietary patterns associated with healthier CRF and body composition in people with a profile of HTN and overweight.</p>","PeriodicalId":8950,"journal":{"name":"Blood Pressure Monitoring","volume":" ","pages":""},"PeriodicalIF":1.2,"publicationDate":"2024-10-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142457188","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-10-04DOI: 10.1097/MBP.0000000000000728
Zijian Xie, Li Zhu, Xiao Zheng, Chaoya Li, Jia Hu, Xinda Wang, Hua Deng, Xiaoqin Du, Jiahui Liang, Bin Peng
This study aimed to validate the accuracy of the test device (TMB-2296-BT) blood pressure (BP) monitor in adults according to International Standard Organization (ISO) 81060-2:2018 + Amd.1:2020 universal standard protocol, which is a digital monitor. Three trained observers used the same arm sequential method to compare the SBPs and DBPs measured by the test device with those measured by the reference device (mercury sphygmomanometer). For the test device with cuff ranging from 22 to 32 cm, there are 88 adults, with a male-to-female ratio of 35 : 53. The mean difference and SD between reference BPs and test device BPs readings were (0.21 ± 2.59)/(0.66 ± 2.12) mmHg for SBP/DBP for criterion 1, and (0.21 ± 2.07)/(0.66 ± 1.76) mmHg for SBP/DBP for criterion 2. For the test device with cuffs ranging from 22 to 42 cm, there are 87 adults, with a male-to-female ratio of 49 : 38. The mean difference and SD between reference BPs and test device BPs readings were (-1.62 ± 2.80)/(0.12 ± 3.01) mmHg for SBP/DBP for criterion 1, and (-1.62 ± 2.35)/(0.12 ± 2.60) mmHg for SBP/ DBP for criterion 2. And for the test device with cuff arm circumference sizes of 22-32 cm and 22-42 cm fulfilled both validation criterion 1 and 2 of the ISO 81060-2:2018 + Amd.1:2020 standard and can be recommended for both clinical and self/home BP measurement in adults.
{"title":"Validation of the TMB-2296-BT blood pressure monitor in adults according to the ISO 81060-2:2018 + Amd.1:2020.","authors":"Zijian Xie, Li Zhu, Xiao Zheng, Chaoya Li, Jia Hu, Xinda Wang, Hua Deng, Xiaoqin Du, Jiahui Liang, Bin Peng","doi":"10.1097/MBP.0000000000000728","DOIUrl":"https://doi.org/10.1097/MBP.0000000000000728","url":null,"abstract":"<p><p>This study aimed to validate the accuracy of the test device (TMB-2296-BT) blood pressure (BP) monitor in adults according to International Standard Organization (ISO) 81060-2:2018 + Amd.1:2020 universal standard protocol, which is a digital monitor. Three trained observers used the same arm sequential method to compare the SBPs and DBPs measured by the test device with those measured by the reference device (mercury sphygmomanometer). For the test device with cuff ranging from 22 to 32 cm, there are 88 adults, with a male-to-female ratio of 35 : 53. The mean difference and SD between reference BPs and test device BPs readings were (0.21 ± 2.59)/(0.66 ± 2.12) mmHg for SBP/DBP for criterion 1, and (0.21 ± 2.07)/(0.66 ± 1.76) mmHg for SBP/DBP for criterion 2. For the test device with cuffs ranging from 22 to 42 cm, there are 87 adults, with a male-to-female ratio of 49 : 38. The mean difference and SD between reference BPs and test device BPs readings were (-1.62 ± 2.80)/(0.12 ± 3.01) mmHg for SBP/DBP for criterion 1, and (-1.62 ± 2.35)/(0.12 ± 2.60) mmHg for SBP/ DBP for criterion 2. And for the test device with cuff arm circumference sizes of 22-32 cm and 22-42 cm fulfilled both validation criterion 1 and 2 of the ISO 81060-2:2018 + Amd.1:2020 standard and can be recommended for both clinical and self/home BP measurement in adults.</p>","PeriodicalId":8950,"journal":{"name":"Blood Pressure Monitoring","volume":" ","pages":""},"PeriodicalIF":1.2,"publicationDate":"2024-10-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142457190","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}