Background: Left atrial appendage occlusion (LAAO) provides an alternative to oral anticoagulation (OAC) for stroke prevention in patients with atrial fibrillation (AF). In patients with a long... Show moreBackground: Left atrial appendage occlusion (LAAO) provides an alternative to oral anticoagulation (OAC) for stroke prevention in patients with atrial fibrillation (AF). In patients with a long-term or permanent contraindication for OAC ran-domized controlled trial (RCT) data is lacking. Study objectives: To assess the efficacy and safety of LAAO in AF patients who are ineligible to use OAC. The co-primary efficacy endpoint is (1) time to first occurrence of stroke (ischemic, hemorrhagic, or undetermined) and (2) time to first occurrence of the composite of stroke, transient ischemic attack (TIA), and systemic embolism (SE). The primary safety endpoint is the 30-day rate of peri-procedural complications. Study design: This is a multicenter, investigator-initiated, open-label, blinded endpoint (PROBE), superiority-driven RCT. Patients with AF, a CHA 2DS 2 -VASc score >= 2 for men and >= 3 for women and a long-term or permanent contraindica-tion for OAC will be randomized in a 2:1 fashion to the device- or control arm. Patients in the device arm will undergo percutaneous LAAO and will receive post-procedural dual antiplatelet therapy (DAPT) per protocol, while those in the control arm will continue their current treatment consisting of no antithrombotic therapy or (D)APT as deemed appropriate by the primary responsible physician. In this endpoint-driven trial design, assuming a 50% lower stroke risk of LAAO compared to conservative treatment, 609 patients will be followed for a minimum of 1 and a maximum of 5 years. Cost-effectiveness and budget impact analyses will be performed to allow decision-making on reimbursement of LAAO for the target population in the Netherlands. Summary: The COMPARE LAAO trial will investigate the clinical superiority in preventing thromboembolic events and cost-effectiveness of LAAO in AF patients with a high thromboembolic risk and a contraindication for OAC use. Show less
Nguyen, B.O.; Weberndorfer, V.; Crijns, H.J.G.M.; Geelhoed, B.; Cate, H. ten; Spronk, H.; ... ; Rienstra, M. 2022
Objective Atrial fibrillation (AF) often progresses from paroxysmal AF (PAF) to more permanent forms. To improve personalised medicine, we aim to develop a new AF progression risk prediction model... Show moreObjective Atrial fibrillation (AF) often progresses from paroxysmal AF (PAF) to more permanent forms. To improve personalised medicine, we aim to develop a new AF progression risk prediction model in patients with PAF.Methods In this interim-analysis of the Reappraisal of AF: Interaction Between HyperCoagulability, Electrical Remodelling, and Vascular Destabilisation in the Progression of AF study, patients with PAF undergoing extensive phenotyping at baseline and continuous rhythm monitoring during follow-up of >= 1 year were analysed. AF progression was defined as (1) progression to persistent or permanent AF or (2) progression of PAF with >3% burden increase. Multivariable analysis was done to identify predictors of AF progression.Results Mean age was 65 (58-71) years, 179 (43%) were female. Follow-up was 2.2 (1.6-2.8) years, 51 of 417 patients (5.5%/year) showed AF progression. Multivariable analysis identified, PR interval, impaired left atrial function, mitral valve regurgitation and waist circumference to be associated with AF progression. Adding blood biomarkers improved the model (C-statistic from 0.709 to 0.830) and showed male sex, lower levels of factor XIIa:C1-esterase inhibitor and tissue factor pathway inhibitor, and higher levels of N-terminal pro-brain natriuretic peptide, proprotein convertase subtilisin/kexin type 9 and peptidoglycan recognition protein 1 were associated with AF progression.Conclusion In patients with PAF, AF progression occurred in 5.5%/year. Predictors for progression included markers for atrial remodelling, sex, mitral valve regurgitation, waist circumference and biomarkers associated with coagulation, inflammation, cardiomyocyte stretch and atherosclerosis. These prediction models may help to determine risk of AF progression and treatment targets, but validation is needed. Show less
Overbeek, C.; Kolk, A.; Witte, P.B. de; Nagels, J.; Nelissen, R.G.H.; Groot, J. de 2022
Background: Patients with Subacromial Pain Syndrome show reduced co-contraction of the teres major during abduction. Consequent insufficient humeral depressor function may contribute to painful... Show moreBackground: Patients with Subacromial Pain Syndrome show reduced co-contraction of the teres major during abduction. Consequent insufficient humeral depressor function may contribute to painful irritation of subacromial tissues and offers a potential target for therapy. A crucial gap in knowledge is whether the degree of teres major co-contraction in these patients is influenced by pain itself. To gain insight into this matter, we assessed whether relief of subacromial pain with local analgesics leads to increased adductor co-contraction in 34 patients with subacromial pain. Methods: In a single-arm interventional study with 34 patients, electromyographic activity of the latissimus dorsi, pectoralis major, teres major and deltoid was assessed during isometric force tasks in 24 directions before and after subacromial Lidocaine injection. Co-contraction was quantified using the activation ratio; range [-1 (sole antagonistic activation, i.e. co-contraction) to 1 (sole agonistic activation)]. Findings: There were no changes in activation ratio of the teres major after the intervention (Z-score:-0.6, p = 0.569). The activation ratio of the latissimus dorsi increased to 0.38 (quartiles: 0.13-0.76), indicating decreased co-contraction (Z-score: -2.0, p = 0.045). Interpretation: Subacromial analgesics led to a decrease in co-contraction of the latissimus dorsi, whereas no change in the degree of teres major co-contraction was observed. This study shows that decreased teres major co contraction in patients with subacromial pain, likely is not the consequence of pain itself, opening a window for physical therapy with training of teres major co-contraction to reduce subacromial irritation and pain. Level of evidence: Level II treatment study. Show less
Broeks, G.J.; Herik, L.J. van den; Aerdts, W.J.M.; Casteleijn, L.F.F.; Ginkel, B. van; Groot, J. de; ... ; Ryngaert, C. 2021
Patients with poor upper limb motor recovery after stroke are likely to develop increased resistance to passive wrist extension, i.e., wrist hyper-resistance. Quantification of the underlying... Show morePatients with poor upper limb motor recovery after stroke are likely to develop increased resistance to passive wrist extension, i.e., wrist hyper-resistance. Quantification of the underlying neural and non-neural elastic components is of clinical interest. This cross-sectional study compared two methods: a commercially available device (NeuroFlexor (R)) with an experimental EMG-based device (Wristalyzer) in 43 patients with chronic stroke. Spearman's rank correlation coefficients (r) between components, modified Ashworth scale (MAS) and range of passive wrist extension (PRoM) were calculated with 95% confidence intervals. Neural as well as elastic components assessed by both devices were associated (r = 0.61, 95%CI: 0.38-0.77 and r = 0.53, 95%CI: 0.28-0.72, respectively). The neural component assessed by the NeuroFlexor (R) associated significantly with the elastic components of NeuroFlexor (R) (r = 0.46, 95%CI: 0.18-0.67) and Wristalyzer (r = 0.36, 95%CI: 0.06-0.59). The neural component assessed by the Wristalyzer was not associated with the elastic components of both devices. Neural and elastic components of both devices associated similarly with the MAS (r = 0.58, 95%CI: 0.34-0.75 vs. 0.49, 95%CI: 0.22-0.69 and r = 0.51, 95%CI: 0.25-0.70 vs. 0.30, 95%CI: 0.00-0.55); elastic components associated with PRoM (r = -0.44, 95%CI: -0.65- -0.16 vs. -0.74, 95%CI: -0.85- -0.57 for NeuroFlexor (R) and Wristalyzer respectively). Results demonstrate that both methods perform similarly regarding the quantification of neural and elastic wrist hyper-resistance components and have an added value when compared to clinical assessment with the MAS alone. The added value of EMG in the discrimination between neural and non-neural components requires further investigation. Show less
Zoest, R.A. van; Law, M.; Sabin, C.A.; Vaartjes, I.; Valk, M. van der; Arends, J.E.; ... ; Elst-Laurijssen, D.H. 2019
The gender difference in the prevalence of depression is well-documented, poorly understood and multifactorial. Considering that gender differences exist in the expression of emotions, we... Show moreThe gender difference in the prevalence of depression is well-documented, poorly understood and multifactorial. Considering that gender differences exist in the expression of emotions, we hypothesized that ambivalence over the expression of sadness and anger contributes to the difference in depression scores between men and women. Questionnaires on depressive symptoms and ambivalence regarding sadness and anger expression were completed by 550 respondents (66.9% women, average age 27.8years). Women reported more depressive symptoms and were more ambivalent over the expression of both sadness and anger than men. Ambivalence over sadness andto a lesser extentanger mediated the relationship between gender and depressive symptoms. We conclude that ambivalence over emotion expression may partly explain why depression occurs more frequently in women than men. Show less
Kinematics is the analysis of motions without regarding forces or inertial effects, with the purpose of understanding joint behaviour. Kinematic data of linked joints, for example the upper... Show moreKinematics is the analysis of motions without regarding forces or inertial effects, with the purpose of understanding joint behaviour. Kinematic data of linked joints, for example the upper extremity, i.e. the shoulder and arm joints, contains many related degrees of freedom that complicate numerical analysis. Visualisation techniques enhance the analysis process, thus improving the effectiveness of kinematic experiments. This paper describes a new visualisation system specifically designed for the analysis of multi-joint kinematic data of the upper extremity. The challenge inherent in the data is that the upper extremity is comprised of five cooperating joints with a total of fifteen degrees of freedom. The range of motion may be affected by subtle deficiencies of individual joints that are difficult to pinpoint. To highlight these subtleties our approach combines interactive filtering and multiple visualisation techniques. Our system is further differentiated by the fact that it integrates simultaneous acquisition and visual analysis of biokinematic data. Also, to facilitate complex queries, we have designed a visual query interface with visualisation and interaction elements that are based on the domain-specific anatomical representation of the data. The combination of these techniques form an effective approach specifically tailored for the investigation and comparison of large collections of kinematic data. This claim is supported by an evaluation experiment where the technique was used to inspect the kinematics of the left and right arm of a patient with a healed proximal humerus fracture, i.e. a healed shoulder fracture. Show less
