Impact of first-line use of caplacizumab on treatment outcomes in immune thrombotic thrombocytopenic purpura.

BACKGROUND: The von Willebrand factor-directed nanobody caplacizumab has greatly changed the treatment of immune thrombotic thrombocytopenic purpura (iTTP) in recent years. Data from randomized controlled trials established efficacy and safety. OBJECTIVES: This study aims to address open questions regarding patient selection, tailoring of therapy duration, obstacles in prescribing caplacizumab in iTTP, effect on adjunct treatment, and outcomes in the real-world setting. METHODS: We report retrospective, observational cohorts of 113 iTTP episodes treated with caplacizumab and 119 historical control episodes treated without caplacizumab. We aggregated data from the caplacizumab phase II/III trials and real-world data from France, the United Kingdom, Germany, and Austria (846 episodes, 396 treated with caplacizumab, and 450 historical controls). RESULTS: Caplacizumab was efficacious in iTTP, independent of the timing of therapy initiation, but curtailed the time of active iTTP only when used in the first-line therapy within 72 hours after diagnosis and until at least partial ADAMTS13-activity remission. Aggregated data from multiple study populations showed that caplacizumab use resulted in significant absolute risk reduction of 2.87% for iTTP-related mortality (number needed to treat 35) and a relative risk reduction of 59%. CONCLUSION: Caplacizumab should be used in first line and until ADAMTS13-remission, lowers iTTP-related mortality and refractoriness, and decreases the number of daily plasma exchange and hospital stay. This trial is registered at www. CLINICALTRIALS: gov as #NCT04985318.

Comparison of two blood pressure oscillometric devices: Datascope Accutorr Plus and Mobil-O-Graph PWA and conversion of blood pressure values from one device to the other.

OBJECTIVE: This study aims to compare two oscillometric devices used in national health surveys in Germany, Datascope Accutorr Plus and Mobil-O-Graph PWA and to develop formulas for the conversion of blood pressure (BP) values. METHODS: One hundred and four adults aged 21-86 years had nine alternate same-arm BP measurements according to the International Protocol revision 2010 for the validation of BP measuring devices in adults of the European Society of Hypertension. Measurements 2-8 yielded six pairs of measurements at 30- to 60-second interval with the two devices, totaling 743 pairs used for analysis. RESULTS: Mean Mobil-O-Graph SBP and DBP were higher than those from Datascope. Mean differences (Mobil-O-Graph minus Datascope) increased within BP ranges (optimal, normal, high normal, hypertensive stage 1, stage 2 and stage 3): SBP 0.5 ± 8.5, 3.1 ± 8.2, 3.7 ± 8.0, 5.3 ± 8.8, 13.8 ± 10.2 and 15.0 ± 25.9, respectively, and DBP 2.6 ± 5.6, 6.0 ± 4.9, 6.6 ± 5.2, 8.4 ± 4.8, 12.3 ± 4.6 and 20.4 ± 4.2, respectively. For Mobil-O-Graph pulse pressure less than 43 mm Hg, the DBP difference was 6.3 ± 5.5, and for Mobil-O-Graph pulse pressure more than 50 mm Hg, the SBP difference was 7.4 ± 9.3. The prevalence of BP at least 140/90 mm Hg was 28.8% with Mobil-O-Graph and 20.5% with Datascope. Bidirectional conversion models of SBP and DBP adjusting for BP, pulse pressure, sex, age and cuff width to arm circumference ratio were developed. CONCLUSION: The disagreement in oscillometric devices can reach a magnitude that can be relevant for clinical and epidemiological contexts. The here generated conversion formulas may help to improve comparability.

Author Correction: Predictors for success in renal denervation-a single centre retrospective analysis.

An amendment to this paper has been published and can be accessed via a link at the top of the paper.

Validation of noninvasive oscillometric blood pressure 2020 up pressure upper arm blood pressure monitoring technology according to the European Society of Hypertension International Protocol revision 2010.

To validate noninvasive oscillometric blood pressure (NIBP) 2020 up pressure (UP) upper arm blood pressure (BP) monitoring technology according to the European Society of Hypertension International Protocol revision 2010 (ESH-IP revision 2010). According to the protocol, 33 participants were included. NIBP2020 UP technology was integrated into the BP+ host device, and common upper arm cuffs were used. The study included patients from ambulatory Hypertension Units. The validation procedure was performed exactly as required by ESH-IP revision 2010. Overall, 57.6% of the study population was female. Mean age was 45.5±16.3 years. Mean systolic blood pressure (SBP) was 142.9±30.6 mmHg and mean diastolic blood pressure (DBP) was 89.0±24.9 mmHg. The number of measurements within the difference range of up to 5 mmHg was 86 for SBP and 92 for DBP; 95 measurements of SBP and 99 of DBP were within the difference range of up to 10 mmHg, and 97 measurements of SBP and 99 measurement of DBP were in the difference range of up to 15 mmHg. Mean observer-test device differences were -0.2±4.6 mmHg for SBP and 0.6±3.1 mmHg for DBP. At least two observer-test differences were up to 5 mmHg for SBP in all participants and for DBP in 31 participants. All participants had at least one measurement with an observer-test difference of up to 5 mmHg for SBP and DBP. The NIBP2020 UP technology integrated into the BP+ host device using common upper arm cuffs passed the validation criteria according to the ESH-IP revision 2010.

Predictors for success in renal denervation-a single centre retrospective analysis.

Renal denervation (RDN) is one of the most frequently used invasive methods for the treatment of arterial hypertension. However, recent randomized sham-controlled studies raised concern about the efficacy and predictability of response. We retrospectively analyzed outcomes of patients, who underwent RDN in our hypertension center between November 2010 and April 2014 and report here outcomes twelve months after procedure based on 24-hours ambulatory blood pressure monitoring. We defined ten-mm Hg decrease in office systolic blood pressure (SBP) as a cut-off for response and looked for possible predictors of this response using binary multiple regression analysis. 42 patients were included. Their mean age was 59.6 ± 9.2 years and 24% were female. Baseline office SBP and diastolic blood pressure (DBP) were 164.1 ± 20.3 and 91.8 ± 12.4 mm Hg respectively. Mean 24 h-SBP significantly decreased from 149.8 ± 13.3 mm Hg to 141.2 ± 14.6 mm Hg. Mean 24 h-DBP significantly decreased from 83.3 ± 11.7 mm Hg to 78.8 ± 11.2 mm Hg. A higher level of mean 24 h-DBP and office DBP was shown to be predictive for response in office BP and a higher level of mean 24 h-DBP for response in 24 h-SBP and 24 h-DBP. Further properly designed randomized trials are warranted to confirm this finding as well as further investigate the role of diabetes mellitus and arterial stiffness in RDN.

Oscillometric assessment of arterial stiffness in everyday clinical practice.

Measurement of carotid-femoral pulse wave velocity (cfPWV) is considered the gold standard for assessing arterial stiffness. Although widely used in clinical and observational studies, the detection of cfPWV has not yet been applied in everyday clinical practice due to technical and procedural difficulties. We, therefore, evaluated the applicability of oscillometric cfPWV assessment for everyday clinical practice. Eighty-nine patients were prospectively included in the study. Oscillometric calculations of cfPWV were performed with Tel-O-GRAPH and tonometric calculations with Sphygmocor. The accuracy, reproducibility, reliability and robustness of Tel-O-GRAPH calculations in different clinical situations were evalu??ated. The mean study population age was 48.8±19.1 years. More than half (59.6%) of the patients were male, and 15.1% were smokers. The mean difference of PWV between devices was 0.49±1.26 m s-1 (P<0.0001), and the Pearson correlation index was 0.86 (P<0.0001). The coefficient of variation and intraclass correlation coefficients between three single measured PWV values with the Tel-O-GRAPH and Sphygmocor were 2.38±6.13% vs. 6.3±4.33% (P<0.05) and 0.99; 0.99; and 0.99 vs. 0.78; 0.84; and 0.71, respectively. For Tel-O-GRAPH, there was no statistically significant difference between PWV in seated vs. supine positions or by experienced or inexperienced users. High reproducibility and reliability of the calculated single PWV values with Tel-O-GRAPH and considerable performance accuracy compared with Sphygmocor were observed. The reported evidence suggests that oscillometry might evolve as a favored method for the assessment of the PWV in everyday clinical practice and in clinical studies due to its ease of use, accuracy and robustness.

Validation of the Tel-O-GRAPH, a new oscillometric blood pressure-measuring device, according to the British Hypertension Society protocol.

OBJECTIVE: Hypertension is a major cardiovascular risk factor. Therefore, the accuracy of blood pressure (BP) measurement with self-measuring devices is of fundamental importance. Consequently, emerging BP devices should be evaluated against the gold standard according to an established and proven protocol. METHODS: Tel-O-GRAPH, a new oscillometric self-measuring device of brachial BP, was evaluated against auscultatory sphygmomanometry according to the BHS protocol. Bland-Altman plots were completed for systolic (SBP) and diastolic blood pressures (DBP), and the mean differences and SDs between the test device and the reference device were computed for all BP values. RESULTS: A total of 85 individuals (mean age 48.11±18.0 years; 61% men) were included after they provided informed consent. Overall, 510 measurements were performed. The mean device-observer difference was -0.2±6.6 for SBP and 0.2±6.6 for DBP. The device achieved grade A for SBP and DBP for both observers. Examination of the different BP ranges indicated grade B for SBP more than 160 mmHg and grade A for all BP ranges. CONCLUSION: Tel-O-GRAPH fulfilled the accuracy requirements of the BHS with the highest accuracy level (A) and can thus be used reliably in the oscillometric measurement of the brachial BP.

Oscillometric estimation of central blood pressure: validation of the Mobil-O-Graph in comparison with the SphygmoCor device.

BACKGROUND: Hypertension is a major risk factor for a wide range of cardiovascular diseases and is typically identified by measuring blood pressure (BP) at the brachial artery. Although such a measurement may accurately determine diastolic BP, systolic BP is not reflected accurately. Current noninvasive techniques for assessing central aortic BP require additional recording of an arterial pressure wave using a high-fidelity applanation tonometer. Within one measurement cycle, the Mobil-O-Graph BP device uses brachial oscillometric BP waves for a noninvasive estimation of central BP. We therefore validated the Mobil-O-Graph against the SphygmoCor device, which is widely known as the commonly used approach for a noninvasive estimation of central BP. METHODS: For each individual, we compared three readings of the central BP values obtained by the Mobil-O-Graph and SphygmoCor device consecutively. One hundred individuals (mean age 56.1 ± 15.4 years) were recruited for measurement.Differences between the central BP values of the test device and the SphygmoCor device were calculated for each measurement. RESULTS: The mean difference (95% confidence interval) for the estimated central systolic BP between both devices was -0.6 ± 3.7 mmHg. Comparison of the central BP values measured by the two devices showed a statistically significant linear correlation (R=0.91, P<0.0001). The mean between-method difference was 0.50 mmHg for central systolic BP estimation. The intrarater reproducibility between both the devices was also comparable. Bland and Altman analyses showed that the mean differences (95% confidence interval) between repeated measurements were 1.89 (0.42-3.36) mmHg and 1.36 (-0.16 to 2.83) mmHg for the SphygmoCor and the Mobil-O-Graph device, respectively. Thus, neither of these differences was statistically significantly different from 0. The limits of agreement were -16.34 to 19.73 and -15.23 to 17.17 mmHg for the SphygmoCor and the Mobil-O-Graph device, respectively. CONCLUSION: Oscillometric noninvasive estimation of central BP with the Mobil-O-Graph BP device is as effective as using the well-established SphygmoCor applanation tonometry device. In comparison, the Mobil-O-Graph combines the widespread benefits of brachial BP measurement and also provides central BP within one measurement.