Background. In a phase 1 study, we investigated whether interferon beta reduced endothelial damage in patients with cardiac persistence of human parvovirus B19 (B19V) infection. Methods and results. ...In vitro, B19V infected cultivated endothelial cells (ECs), which led to a reduction in their viability (P = .007). Interferon beta suppressed B19V replication by 63% (P = .008) in ECs and increased their viability (P = .021 ). Circulating mature apoptotic ECs (CMAECs CD45−CD146+ cells expressing von Willebrand factor and annexin V) and circulating progenitor cells (CPCs CD34+KDR+ cells) were quantified by flow cytometry in 9 symptomatic patients with cardiac B19V infection before and after 6 months of interferon beta therapy (16 MU) and were compared to levels in 9 healthy control subjects. Endothelial dysfunction was measured using flow-mediated dilatation of the forearm. Patients with B19V persistence had significantly higher (P = .004) levels of CMAECs than did control subjects, which normalized after treatment (mean . standard deviation, 0.06% ± 0.08% vs 0.01% ± 0.006%; P = .008). Similar improvement was shown for flow-mediated dilatation (P = .04) in the treatment group only (P = .017 for the comparison with untreated patients with B19V persistence n = 5). There were significantly higher numbers of CPCs in patients with B19V persistence before therapy (mean ± standard deviation, 0.04% ± 0.05% vs 0.01% ± 0.004%;P = .02) than in control subjects, which normalized after treatment (P = .03). Conclusion. Thus, we present (for the first time, to our knowledge) a modulation of virally induced chronic endothelial damage-specifically, EC apoptosis and endothelial regeneration.
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BFBNIB, NMLJ, NUK, PNG, SAZU, UL, UM, UPUK
For individuals with motor impairments, dynamic standing has been proposed as an opportunity for regular daily physical activity. The aim of this study was to analyse patient characteristics, ...indications, intensity of usage, desired objectives and outcomes of dynamic standing in daily clinical practice in order to form the basis for research regarding this treatment option.
Data were analysed from standardized questionnaires completed prospectively before supply of a home-based medical device for dynamic standing (Innowalk; Made for Movement GmbH, Langenhagen, Germany) and at the time of individual adaptations.
In a retrospective chart analysis, records of 46 patients (50% cerebral palsy; 50% diverse syndromes) were evaluated.
The Innowalk had been prescribed for either home-based use (n = 31), in therapeutic institutions (n = 8), or other settings (n = 7). Dynamic standing was performed for 10-30 min as a single session (n = 8) or for 20-60 min 11 4-21 weeks in 36 patients.
Improvements were found for: passive assisted motion (79%), stimulation of intestinal functions (71%), body stability (64%), joint mobility (56%), secure means of allowing supine position (52%), and revision of abnormal motion patterns (48%).
Thus, this systematic approach shows usage patterns, indications, desired goals and clinical outcome of dynamic standing in daily clinical practice and forms the basis for the design of a prospective, randomized controlled trial.
Circulating endothelial progenitor cells (EPC), involved in endothelial regeneration, neovascularisation, and determination of prognosis in cardiovascular disease can be characterised with functional ...assays or using immunofluorescence and flow cytometry. Combinations of markers, including CD34+KDR+ or CD133+KDR+, are used. This approach, however may not consider all characteristics of EPC. The lack of a standardised protocol with regards to reagents and gating strategies may account for the widespread inter-laboratory variations in quantification of EPC. We, therefore developed a novel protocol adapted from the standardised so-called ISHAGE protocol for enumeration of haematopoietic stem cells to enable comparison of clinical and laboratory data.
In 25 control subjects, 65 patients with coronary artery disease (CAD; 40 stable CAD, 25 acute coronary syndrome/acute myocardial infarction (ACS)), EPC were quantified using the following approach: Whole blood was incubated with CD45, KDR, and CD34. The ISHAGE sequential strategy was used, and finally, CD45(dim)CD34(+) cells were quantified for KDR. A minimum of 100 CD34(+) events were collected. For comparison, CD45(+)CD34(+) and CD45(-)CD34(+) were analysed simultaneously. The number of CD45(dim)CD34(+)KDR(+) cells only were significantly higher in healthy controls compared to patients with CAD or ACS (p = 0.005 each, p<0.001 for trend). An inverse correlation of CD45(dim)CD34(+)KDR(+) with disease activity (r = -0.475, p<0.001) was confirmed. Only CD45(dim)CD34(+)KDR(+) correlated inversely with the number of diseased coronaries (r = -0.344; p<0.005). In a second study, a 4-week de-novo treatment of atorvastatin in stable CAD evoked an increase only of CD45(dim)CD34(+)KDR(+) EPC (p<0.05). CD45(+)CD34(+)KDR(+) and CD45(-)CD34(+)KDR(+) were indifferent between the three groups.
Our newly established protocol adopted from the standardised ISHAGE protocol achieved higher accuracy in EPC enumeration confirming previous findings with respect to the correlation of EPC with disease activity and the increase of EPC during statin therapy. The data of this study show the CD45(dim) fraction to harbour EPC.
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Psychiatric comorbidities are common in somatically ill patients. There is a lack of data that can provide clear insights into substantial comparative advantages of different Consultation/Liaison ...Psychiatry (CLP) services.
The Consultation versus Liaison Psychiatry-Study collected and analyzed data of 890 primarily somatically ill hospital inpatients presenting with psychiatric symptoms in a prospective observational study design. One group was treated via a liaison-model (LM) with regular consultation hours, the other via an on-demand-model (ODM) with individually requested consultations.
Five hundred forty-five LM and 345 ODM patients were compared. Patients in the LM were, on average, older compared to the patients of the ODM. The vast majority (90.8%) of individuals for whom a psychiatric consultation was requested came from internal medicine. The most common diagnoses were affective disorders (39.3%), organic mental disorders (18.9%), alcohol-induced mental disorders (11.3%) and reactions to severe stress/adjustment disorders (10.4%). Organic mental disorders were significantly more common in patients seen in the LM (24.0% vs. 10.3%, p < 0.001) while affective disorders were more frequently diagnosed in the ODM (46.6% vs. 34.8%, p = 0.001). Patients seen in the ODM were, on average, more severely affected compared to patients seen in the LM and required more extensive treatment. 16.3% of ODM patients were regarded as potentially suicidal; among these, 3.5% were acutely suicidal and 12.8% latently suicidal. Any form of further treatment was required by 93.0% of ODM patients compared to 77.8% in the LM. Pharmacological treatment with benzodiazepines, usually used as short-term treatment, was more frequently prescribed to patients seen in the ODM while patients seen in the LM were more often started on selective serotonin reuptake inhibitors, indicative of long-term treatment.
Patients in need of less acute treatment were considerably less common in the ODM. The data indicate a possible risk of such patients to remain unrecognized. A quasi-liaison model is recommended to be the best suitable and cost-effective way of providing psychiatric care to somatically ill patients with psychiatric comorbidities.
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In evidence-based weight-loss programs weight regain is common after an initial weight reduction. Eating slowly significantly lowers meal energy intake and hunger ratings. Despite this knowledge, ...obese individuals do not implement this behaviour. We, thus tested the hypothesis of changing eating behaviour with an intra-oral medical device leading to constant weight reduction in overweight and obesity. Six obese patients (6 men, age 56 ± 14, BMI 29 ± 2 kg / m2) with increased CVRF profile were included in this prospective study. All patients had been treated for obesity during the last 10 years in a single centre and had at least 3 frustrate evidence-based diets. Patients received a novel non-invasive intra-oral medical device to slow eating time. Further advice included not to count calories, to avoid any other form of diet, to take their time with their meals, and to eat whatever they liked. This device was used only during meals for the first 4 to 8 weeks for a total of 88 20-160 hours. Follow-up period was 23 15-38 months. During this period, patients lost 11% 5-20% (p<0.001) of their initial weight. At 12 months, all patients had lost >5%, and 67% (4/6) achieved a >10% bodyweight loss. In the course of the study, altered eating patterns were observed. There were no complications with the medical device. Of note, all patients continued to lose weight after the initial intervention period (p<0.001) and none of them had weight regain. With this medical device, overweight and obese patients with a history of previously frustrating attempts to lose weight achieved a significant and sustained weight loss over two years. These results warrant the ongoing prospective randomised controlled trial to prove concept and mechanism of action.
German Clinical Trials Register DRKS00011357.
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Circulating progenitor cells (CPC) contribute to the homeostasis of the vessel wall, and a reduced CPC count predicts cardiovascular morbidity and mortality. We tested the hypothesis that CPC count ...improves cardiovascular risk stratification and that this is modulated by low-grade inflammation.
We pooled data from 4 longitudinal studies, including a total of 1,057 patients having CPC determined and major adverse cardiovascular events (MACE) collected. We recorded cardiovascular risk factors and high-sensitive C-reactive protein (hsCRP) level. Risk estimates were derived from Cox proportional hazard analyses. CPC count and/or hsCRP level were added to a reference model including age, sex, cardiovascular risk factors, prevalent CVD, chronic renal failure (CRF) and medications. The sample was composed of high-risk individuals, as 76.3% had prevalent CVD and 31.6% had CRF. There were 331 (31.3%) incident MACE during an average 1.7+/-1.1 year follow-up time. CPC count was independently associated with incident MACE even after correction for hsCRP. According to C-statistics, models including CPC yielded a non-significant improvement in accuracy of MACE prediction. However, the integrated discrimination improvement index (IDI) showed better performance of models including CPC compared to the reference model and models including hsCRP in identifying MACE. CPC count also yielded significant net reclassification improvements (NRI) for CV death, non-fatal AMI and other CV events. The effect of CPC was independent of hsCRP, but there was a significant more-than-additive interaction between low CPC count and raised hsCRP level in predicting incident MACE.
In high risk individuals, a reduced CPC count helps identifying more patients at higher risk of MACE over the short term, especially in combination with a raised hsCRP level.
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This study evaluated the single-leg vertical hop test (SLVHT), using digital sensor technology, for the functional assessment of rehabilitation progress in patients after ACL reconstruction (ACL-R). ...Between January 2019 and June 2022, 143 patients (26.6 (8.9) years, m/f 66/34%) completed return-to-sport testing at 3 and 6 months after ACL-R. The jump height during SLVHT was quantified with a digital motion sensor, containing a three-axis acceleration gyroscope sensor, and the limb symmetry index (LSI) (injured/non-injured leg ratio) was calculated. Three months postoperatively, the jump height of the injured leg was 59.6% (13.5 (5.5) cm) that of the non-injured leg (22.9 (6.2) cm; p < 0.01). After 6 months, the jump height of the injured leg (18.4 (6.9) cm) improved by 44.1% compared to that at the 3-month follow-up but was still lower than the non-injured leg jump height (23.2 (7.0) cm, p < 0.001; LSI = 79.6%). Men jumped higher than women, but their LSI was not different at 3 (59.6 vs. 59.5%) and 6 months (80.6 vs. 77.8%). Regression analysis identified the non-injured leg jump height as the primary independent predictor of the jump height of the injured leg (β = 0.776, T = 51.506, p < 0.001). SLVHT, using digital sensor technology, is a simple and cost-effective functional test to assess rehabilitation progress after ACL-R, with the potential for multi-centre data analysis.
In order to successfully implement individualized patient rehabilitation and home-based rehabilitation programs, the rehabilitation process should be objectifiable, monitorable and comprehensible. ...For this purpose, objective measurements are required in addition to subjective measurement tools. Thus, the aim of this prospective, single-center clinical trial is the clinical validation of an objective, digital medical device (DMD) during the rehabilitation after anterior cruciate ligament reconstruction (ACLR) with regards to an internationally accepted measurement tool. Sixty-seven patients planned for primary ACLR (70:30% male–female, aged 25 years 21–32, IKDC-SKF 47 31–60, Tegner Activity Scale 6 4–7, Lysholm Score 57 42–72) were included and received physical therapy and the DMD after surgery. For clinical validation, combined measures of range of motion (ROM), coordination, strength and agility were assessed using the DMD in addition to patient-reported outcome measures (PROMs) at three and six months after ACLR. Significant correlations were detected for ROM (rs = 0.36–0.46, p < 0.025) and strength/agility via the single-leg vertical jump (rs = 0.43, p = 0.011) and side hop test (rs = 0.37, p = 0.042), as well as for coordination via the Y-Balance test (rs = 0.58, p ≤ 0.0001) regarding the IKDC-SKF at three months. Additionally, DMD test results for coordination, strength and agility (Y-Balance test (rs = 0.50, p = 0.008), side hop test (rs = 0.54, p = 0.004) and single-leg vertical jump (rs = 0.44, p = 0.018)) correlate significantly with the IKDC-SKF at six months. No adverse events related to the use of the sensor-based application were reported. These findings confirm the clinical validity of a DMD to objectively quantify knee joint function for the first time. This will have further implications for clinical and therapeutic decision making, quality control and monitoring of rehabilitation measures as well as scientific research.
Abstract only
Introduction:
Artificial Intelligence-based 5-lead 3D-vectorcardiography (5L3DVCG-AI) offers additional information over 12-lead electrocardiography (ECG) in the detection of ...significant coronary stenoses. 5L3DVCG-AI is under investigation as a new screening tool for coronary vascular disease (CVD). Hypothesis: We tested the hypothesis of variables from the reconstructed “12-lead ECG” (5L12L-ECG, modified Dower transformation) corresponding with the standard 12-lead ECG (ECG).
Methods:
In this monocentric exploratory retrospective study, raw data of 331 patients with 5L3DVCG-AI and ECG were included. Cardiac pathology (CP) was categorised as exclusion of any CP (control), mild CP or overt CP by 2 independent cardiologists. The following variables were compared: RR-interval, P, PQ, QRS, QT, QTcB, QTcF, QRS-morphology, and ST-morphology. Cardiovascular risk factors (CVRF) were quantified with the modified PROCAM score.
Results:
From 331 patients (m:w 60:40%, 50.0 ± 19.8 years) of mixed ethnicity and moderate CVRF (2.1 ± 1.2), 70% were controls, 21% had mild CP and 9% overt CP. All variables from reconstructed 5L12L-ECG correlated to the corresponding individual variables from ECG (r= 0.49 to 0.7, p<0.001). With identical RR-intervals in both methods, all defined variables were significantly, but irrelevantly or mildly (Cohen’s d) different in 5L12L-ECG compared to ECG (P 106 ± 12 vs. 109 ±20 (
d
=0.3), PQ 152 ± 24 vs. 159 ± 26 (
d
=0.3), QRS 105 ± 16 vs. 97 ± 14 (
d
=0.7), QT 380 ± 33 vs. 396 ± 27 (
d
=0.46), QTcB 432 ± 31 vs. 426 ± 25 (
d
=0.57), QTcF 414 ± 26 vs. 416 ± 19 (
d
=0.53). 5L3DVCG-AI was able to distinguish between controls and patients with CVD (Sensitivity 78%, Specificity 66%, p=0.01). Comparing heart axis, there was a small, but significant difference with a significant correlation between methods (r=0.30, p<0.01).
Conclusions:
The easy to use 5-lead ECG may thus be used in clinical practice to reconstruct valid 12-lead ECG curves without major training or expertise. Additionally, 5L3DVCG-AI can identify persons at risk for CVD. Shorter values for the defined variable will have to be considered when interpreting 5L12L-ECG and separate “normal” value ranges will be given and validated in the ongoing prospective large-scale performance clinical trials.
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