TY - JOUR A1 - Dissmann, R. A1 - Cromme, L. J. A1 - Salzwedel, Annett A1 - Taborski, U. A1 - Kunath, J. A1 - Gaebler, F. A1 - Heyne, K. A1 - Völler, Heinz T1 - Computer aided dosage management of phenprocoumon anticoagulation therapy Clinical validation JF - Hämostaseologie : Organ der Gesellschaft für Thrombose- und Hämostaseforschung e.V. (GTH) N2 - A recently developed multiparameter computer-aided expert system (TheMa) for guiding anticoagulation with phenprocoumon (PPC) was validated by a prospective investigation in 22 patients. The PPC-INR-response curve resulting from physician guided dosage was compared to INR values calculated by "twin calculation" from TheMa recommended dosage. Additionally, TheMa was used to predict the optimal time to perform surgery or invasive procedures after interruption of anticogulation therapy. Results: Comparison of physician and TheMa guided anticoagulation showed almost identical accuracy by three quantitative measures: Polygon integration method (area around INR target) 616.17 vs. 607.86, INR hits in the target range 166 vs. 161, and TTR (time in therapeutic range) 63.91 vs. 62.40 %. After discontinuation of anticoagulation therapy, calculating the INR phase-out curve with TheMa INR prognosis of 1.8 was possible with a standard deviation of 0.50 +/- 0.59 days. Conclusion: Guiding anticoagulation with TheMa was as accurate as Physician guided therapy. After interruption of anticoagulant therapy, TheMa may be used for calculating the optimal time performing operations or initiating bridging therapy. KW - Oral anticoagulation therapy KW - warfarin KW - phenprocoumon KW - computer aided dosage KW - expert system Y1 - 2014 U6 - https://doi.org/10.5482/HAMO-13-06-0030 SN - 0720-9355 VL - 34 IS - 3 SP - 226 EP - 232 PB - Schattauer CY - Stuttgart ER - TY - JOUR A1 - Eichler, Sarah A1 - Rabe, Sophie A1 - Salzwedel, Annett A1 - Müller, Steffen A1 - Stoll, Josefine A1 - Tilgner, Nina A1 - John, Michael A1 - Wegschneider, Karl A1 - Mayer, Frank A1 - Völler, Heinz T1 - Effectiveness of an interactive telerehabilitation system with home-based exercise training in patients after total hip or knee replacement BT - Study protocol for a multicenter, superiority, no-blinded randomized controlled trial JF - Trials N2 - Background Total hip or knee replacement is one of the most frequently performed surgical procedures. Physical rehabilitation following total hip or knee replacement is an essential part of the therapy to improve functional outcomes and quality of life. After discharge from inpatient rehabilitation, a subsequent postoperative exercise therapy is needed to maintain functional mobility. Telerehabilitation may be a potential innovative treatment approach. We aim to investigate the superiority of an interactive telerehabilitation intervention for patients after total hip or knee replacement, in comparison to usual care, regarding physical performance, functional mobility, quality of life and pain. Methods/design This is an open, randomized controlled, multicenter superiority study with two prospective arms. One hundred and ten eligible and consenting participants with total knee or hip replacement will be recruited at admission to subsequent inpatient rehabilitation. After comprehensive, 3-week, inpatient rehabilitation, the intervention group performs a 3-month, interactive, home-based exercise training with a telerehabilitation system. For this purpose, the physiotherapist creates an individual training plan out of 38 different strength and balance exercises which were implemented in the system. Data about the quality and frequency of training are transmitted to the physiotherapist for further adjustment. Communication between patient and physiotherapist is possible with the system. The control group receives voluntary, usual aftercare programs. Baseline assessments are investigated after discharge from rehabilitation; final assessments 3 months later. The primary outcome is the difference in improvement between intervention and control group in 6-minute walk distance after 3 months. Secondary outcomes include differences in the Timed Up and Go Test, the Five-Times-Sit-to-Stand Test, the Stair Ascend Test, the Short-Form 36, the Western Ontario and McMaster Universities Osteoarthritis Index, the International Physical Activity Questionnaire, and postural control as well as gait and kinematic parameters of the lower limbs. Baseline-adjusted analysis of covariance models will be used to test for group differences in the primary and secondary endpoints. Discussion We expect the intervention group to benefit from the interactive, home-based exercise training in many respects represented by the study endpoints. If successful, this approach could be used to enhance the access to aftercare programs, especially in structurally weak areas. KW - Telerehabilitation KW - Home-based KW - Total hip replacement KW - Total knee replacement KW - Exercise therapy KW - Aftercare Y1 - 2017 U6 - https://doi.org/10.1186/s13063-017-2173-3 SN - 1745-6215 VL - 18 SP - 1 EP - 7 PB - BioMed Central CY - London ER - TY - JOUR A1 - Eichler, Sarah A1 - Salzwedel, Annett A1 - Rabe, Sophie A1 - Mueller, Steffen A1 - Mayer, Frank A1 - Wochatz, Monique A1 - Hadzic, Miralem A1 - John, Michael A1 - Wegscheider, Karl A1 - Völler, Heinz T1 - The Effectiveness of Telerehabilitation as a Supplement to Rehabilitation in Patients After Total Knee or Hip Replacement BT - Randomized Controlled Trial JF - JMIR Rehabilitation and Assistive Technologies N2 - Background: Telerehabilitation can contribute to the maintenance of successful rehabilitation regardless of location and time. The aim of this study was to investigate a specific three-month interactive telerehabilitation routine regarding its effectiveness in assisting patients with physical functionality and with returning to work compared to typical aftercare. Objective: The aim of the study was to investigate a specific three-month interactive telerehabilitation with regard to effectiveness in functioning and return to work compared to usual aftercare. Methods: From August 2016 to December 2017, 111 patients (mean 54.9 years old; SD 6.8; 54.3% female) with hip or knee replacement were enrolled in the randomized controlled trial. At discharge from inpatient rehabilitation and after three months, their distance in the 6-minute walk test was assessed as the primary endpoint. Other functional parameters, including health related quality of life, pain, and time to return to work, were secondary endpoints. Results: Patients in the intervention group performed telerehabilitation for an average of 55.0 minutes (SD 9.2) per week. Adherence was high, at over 75%, until the 7th week of the three-month intervention phase. Almost all the patients and therapists used the communication options. Both the intervention group (average difference 88.3 m; SD 57.7; P=.95) and the control group (average difference 79.6 m; SD 48.7; P=.95) increased their distance in the 6-minute-walk-test. Improvements in other functional parameters, as well as in quality of life and pain, were achieved in both groups. The higher proportion of working patients in the intervention group (64.6%; P=.01) versus the control group (46.2%) is of note. Conclusions: The effect of the investigated telerehabilitation therapy in patients following knee or hip replacement was equivalent to the usual aftercare in terms of functional testing, quality of life, and pain. Since a significantly higher return-to-work rate could be achieved, this therapy might be a promising supplement to established aftercare. KW - telerehabilitation KW - home-based KW - total hip replacement KW - total knee replacement KW - exercise therapy KW - aftercare KW - rehabilitation Y1 - 2019 U6 - https://doi.org/10.2196/14236 SN - 2369-2529 VL - 6 IS - 2 PB - jmir rehab CY - Toronto ER - TY - JOUR A1 - Eichler, Sarah A1 - Salzwedel, Annett A1 - Reibis, Rona A1 - Nothroff, Jörg A1 - Harnath, Axel A1 - Schikora, Martin A1 - Butter, Christian A1 - Wegscheider, Karl A1 - Völler, Heinz T1 - Multicomponent cardiac rehabilitation in patients after transcatheter aortic valve implantation BT - predictors of functional and psychocognitive recovery JF - European journal of preventive cardiology : the official ESC journal for primary & secondary cardiovascular prevention, rehabilitation and sports cardiology N2 - Background: In the last decade, transcatheter aortic valve implantation has become a promising treatment modality for patients with aortic stenosis and a high surgical risk. Little is known about influencing factors of function and quality of life during multicomponent cardiac rehabilitation. Methods: From October 2013 to July 2015, patients with elective transcatheter aortic valve implantation and a subsequent inpatient cardiac rehabilitation were enrolled in the prospective cohort multicentre study. Frailty-Index (including cognition, nutrition, autonomy and mobility), Short Form-12 (SF-12), six-minute walk distance (6MWD) and maximum work load in bicycle ergometry were performed at admission and discharge of cardiac rehabilitation. The relation between patient characteristics and improvements in 6MWD, maximum work load or SF-12 scales were studied univariately and multivariately using regression models. Results: One hundred and thirty-six patients (80.6 +/- 5.0 years, 47.8% male) were enrolled. 6MWD and maximum work load increased by 56.3 +/- 65.3 m (p < 0.001) and 8.0 +/- 14.9 watts (p < 0.001), respectively. An improvement in SF-12 (physical 2.5 +/- 8.7, p = 0.001, mental 3.4 +/- 10.2, p = 0.003) could be observed. In multivariate analysis, age and higher education were significantly associated with a reduced 6MWD, whereas cognition and obesity showed a positive predictive value. Higher cognition, nutrition and autonomy positively influenced the physical scale of SF-12. Additionally, the baseline values of SF-12 had an inverse impact on the change during cardiac rehabilitation. Conclusions: Cardiac rehabilitation can improve functional capacity as well as quality of life and reduce frailty in patients after transcatheter aortic valve implantation. An individually tailored therapy with special consideration of cognition and nutrition is needed to maintain autonomy and empower octogenarians in coping with challenges of everyday life. KW - Cardiac rehabilitation KW - TAVI KW - frailty KW - quality of life KW - exercise capacity Y1 - 2017 U6 - https://doi.org/10.1177/2047487316679527 SN - 2047-4873 SN - 2047-4881 VL - 24 IS - 3 SP - 257 EP - 264 PB - Sage Publ. CY - London ER - TY - JOUR A1 - Eichler, Sarah A1 - Völler, Heinz A1 - Reibis, Rona Katharina A1 - Wegscheider, Karl A1 - Butter, Christian A1 - Harnath, Axel A1 - Salzwedel, Annett T1 - Geriatric or cardiac rehabilitation? BT - Predictors of treatment pathways in advanced age patients after transcatheter aortic valve implantation JF - BMC Cardiovascular Disorders N2 - Background Aim of the study was to find predictors of allocating patients after transcatheter aortic valve implantation (TAVI) to geriatric (GR) or cardiac rehabilitation (CR) and describe this new patient group based on a differentiated characterization. Methods From 10/2013 to 07/2015, 344 patients with an elective TAVI were consecutively enrolled in this prospective multicentric cohort study. Before intervention, sociodemographic parameters, echocardiographic data, comorbidities, 6-min walk distance (6MWD), quality of life and frailty (score indexing activities of daily living [ADL], cognition, nutrition and mobility) were documented. Out of these, predictors for assignment to CR or GR after TAVI were identified using a multivariable regression model. Results After TAVI, 249 patients (80.7 ± 5.1 years, 59.0% female) underwent CR (n = 198) or GR (n = 51). GR patients were older, less physically active and more often had a level of care, peripheral artery disease as well as a lower left ventricular ejection fraction. The groups also varied in 6MWD. Furthermore, individual components of frailty revealed prognostic impact: higher values in instrumental ADL reduced the probability for referral to GR (OR:0.49, p <  0.001), while an impaired mobility was positively associated with referral to GR (OR:3.97, p = 0.046). Clinical parameters like stroke (OR:0.19 of GR, p = 0.038) and the EuroSCORE (OR:1.04 of GR, p = 0.026) were also predictive. Conclusion Advanced age patients after TAVI referred to CR or GR differ in several parameters and seem to be different patient groups with specific needs, e.g. regarding activities of daily living and mobility. Thus, our data prove the eligibility of both CR and GR settings. KW - TAVI KW - Treatment pathways KW - Frailty KW - Geriatric rehabilitation Y1 - 2019 U6 - https://doi.org/10.1186/s12872-020-01452-x SN - 1471-2261 VL - 20 PB - BioMed Central CY - London ER - TY - JOUR A1 - Hofmann, Reiner A1 - Völler, Heinz A1 - Nagels, Klaus A1 - Bindl, Dominik A1 - Vettorazzi, Eik A1 - Dittmar, Ronny A1 - Wohlgemuth, Walter A1 - Neumann, Till A1 - Störk, Stefan A1 - Bruder, Oliver A1 - Wegscheider, Karl A1 - Nagel, Eckhard A1 - Fleck, Eckart T1 - First outline and baseline data of a randomized, controlled multicenter trial to evaluate the health economic impact of home telemonitoring in chronic heart failure - CardioBBEAT JF - Trials N2 - Background: Evidence that home telemonitoring for patients with chronic heart failure (CHF) offers clinical benefit over usual care is controversial as is evidence of a health economic advantage. Methods: Between January 2010 and June 2013, patients with a confirmed diagnosis of CHF were enrolled and randomly assigned to 2 study groups comprising usual care with and without an interactive bi-directional remote monitoring system (Motiva (R)). The primary endpoint in CardioBBEAT is the Incremental Cost-Effectiveness Ratio (ICER) established by the groups' difference in total cost and in the combined clinical endpoint "days alive and not in hospital nor inpatient care per potential days in study" within the follow-up of 12 months. Results: A total of 621 predominantly male patients were enrolled, whereof 302 patients were assigned to the intervention group and 319 to the control group. Ischemic cardiomyopathy was the leading cause of heart failure. Despite randomization, subjects of the control group were more often in NYHA functional class III-IV, and exhibited peripheral edema and renal dysfunction more often. Additionally, the control and intervention groups differed in heart rhythm disorders. No differences existed regarding risk factor profile, comorbidities, echocardiographic parameters, especially left ventricular and diastolic diameter and ejection fraction, as well as functional test results, medication and quality of life. While the observed baseline differences may well be a play of chance, they are of clinical relevance. Therefore, the statistical analysis plan was extended to include adjusted analyses with respect to the baseline imbalances. Conclusions: CardioBBEAT provides prospective outcome data on both, clinical and health economic impact of home telemonitoring in CHF. The study differs by the use of a high evidence level randomized controlled trial (RCT) design along with actual cost data obtained from health insurance companies. Its results are conducive to informed political and economic decision-making with regard to home telemonitoring solutions as an option for health care. Overall, it contributes to developing advanced health economic evaluation instruments to be deployed within the specific context of the German Health Care System. KW - Home telemonitoring KW - Chronic heart failure (CHF) KW - Incremental Cost-Effectiveness Ratio (ICER) KW - Mortality KW - Telemedicine KW - Health economics Y1 - 2015 U6 - https://doi.org/10.1186/s13063-015-0886-8 SN - 1745-6215 VL - 16 PB - BioMed Central CY - London ER - TY - JOUR A1 - Huber, Matthias A1 - Lezius, Susanne A1 - Reibis, Rona Katharina A1 - Treszl, Andras A1 - Kujawinska, Dorota A1 - Jakob, Stefanie A1 - Wegscheider, Karl A1 - Völler, Heinz A1 - Kreutz, Reinhold T1 - A Single Nucleotide Polymorphism near the CYP17A1 Gene Is Associated with Left Ventricular Mass in Hypertensive Patients under Pharmacotherapy JF - International journal of molecular sciences N2 - Cytochrome P450 17A1 (CYP17A1) catalyses the formation and metabolism of steroid hormones. They are involved in blood pressure (BP) regulation and in the pathogenesis of left ventricular hypertrophy. Therefore, altered function of CYP17A1 due to genetic variants may influence BP and left ventricular mass. Notably, genome wide association studies supported the role of this enzyme in BP control. Against this background, we investigated associations between single nucleotide polymorphisms (SNPs) in or nearby the CYP17A1 gene with BP and left ventricular mass in patients with arterial hypertension and associated cardiovascular organ damage treated according to guidelines. Patients (n = 1007, mean age 58.0 +/- 9.8 years, 83% men) with arterial hypertension and cardiac left ventricular ejection fraction (LVEF) 40% were enrolled in the study. Cardiac parameters of left ventricular mass, geometry and function were determined by echocardiography. The cohort comprised patients with coronary heart disease (n = 823; 81.7%) and myocardial infarction (n = 545; 54.1%) with a mean LVEF of 59.9% +/- 9.3%. The mean left ventricular mass index (LVMI) was 52.1 +/- 21.2 g/m(2.7) and 485 (48.2%) patients had left ventricular hypertrophy. There was no significant association of any investigated SNP (rs619824, rs743572, rs1004467, rs11191548, rs17115100) with mean 24 h systolic or diastolic BP. However, carriers of the rs11191548 C allele demonstrated a 7% increase in LVMI (95% CI: 1%-12%, p = 0.017) compared to non-carriers. The CYP17A1 polymorphism rs11191548 demonstrated a significant association with LVMI in patients with arterial hypertension and preserved LVEF. Thus, CYP17A1 may contribute to cardiac hypertrophy in this clinical condition. KW - clinical study KW - genetics KW - heart KW - hypertension KW - cytochrome P450 17A1 (Cyp17A1) Y1 - 2015 U6 - https://doi.org/10.3390/ijms160817456 SN - 1422-0067 VL - 16 IS - 8 SP - 17456 EP - 17468 PB - MDPI CY - Basel ER - TY - JOUR A1 - Huber, Matthias A1 - Treszl, Andras A1 - Reibis, Rona Katharina A1 - Teichmann, Christopher A1 - Zergibel, Irina A1 - Bolbrinker, Juliane A1 - Scholze, Juergen A1 - Wegscheider, Karl A1 - Völler, Heinz A1 - Kreutz, Reinhold T1 - Genetics of melatonin receptor type 2 is associated with left ventricular function in hypertensive patients treated according to guidelines JF - European journal of internal medicine : official journal of the European Federation of Internal Medicine N2 - Background: Melatonin exerts multiple biological effects with potential impact on human diseases. This is underscored by genetic studies that demonstrated associations between melatonin receptor type 2 gene (MTNR1B) polymorphisms and characteristics of type 2 diabetes. We set out to test the hypothesis whether genetic variants at MTNR1B are also relevant for other disease phenotypes within the cardiovascular continuum. We thus investigated single nucleotide polymorphisms (SNPs) of MTNR1B in relation to blood pressure (BP) and cardiac parameters in hypertensive patients. Methods: Patients (n = 605, mean age 56.2 +/- 9.4 years, 82.3% male) with arterial hypertension and cardiac ejection fraction (EF) >= 40% were studied. Cardiac parameters were assessed by echocardiography. Results: The cohort comprised subjects with coronary heart disease (73.1%) and myocardial infarction (48.1%) with a mean EF of 63.7 +/- 8.9%. Analysis of SNPs rs10830962, rs4753426, rs12804291, rs10830963, and rs3781638 revealed two haplotypes 1 and 2 with frequencies of 0.402 and 0.277, respectively. Carriers with haplotype 1 (CTCCC) showed compared to non-carriers a higher mean 24-hour systolic BP (difference BP: 2.4 mm Hg, 95% confidence interval (CI): 0.3 to 4.5 mm Hg, p = 0.023). Haplotype 2 (GCCGA) was significantly related to EF with an absolute increase of 1.8% (CI: 0.45 to 3.14%) in carriers versus non-carriers (p = 0.009). Conclusion: Genetics of MTNR1B point to impact of the melatonin signalling pathway for BP and left ventricular function. This may support the importance of the melatonin system as a potential therapeutic target. KW - Clinical study KW - Genetics KW - Heart KW - Hypertension KW - Melatonin receptor type 2 Y1 - 2013 U6 - https://doi.org/10.1016/j.ejim.2013.03.015 SN - 0953-6205 VL - 24 IS - 7 SP - 650 EP - 655 PB - Elsevier CY - Amsterdam ER - TY - JOUR A1 - Muckelbauer, Rebecca A1 - Englert, Heike A1 - Rieckmann, Nina A1 - Chen, Chih-Mei A1 - Wegscheider, Karl A1 - Völler, Heinz A1 - Katus, Hugo A. A1 - Willich, Stefan N. A1 - Müller-Nordhorn, Jacqueline T1 - Long-term effect of a low-intensity smoking intervention embedded in an adherence program for patients with hypercholesterolemia: Randomized controlled trial JF - Preventive medicine : an international journal devoted to practice and theory N2 - Objective. We evaluated the long-term effect of a smoking intervention embedded in an adherence program in patients with an increased risk for cardiovascular disease. Method. Secondary analysis of a randomized controlled trial: In 2002-2004,8108 patients with hypercholesterolemia were enrolled from general practices in Germany. Patients received a 12-month adherence program and statin medication (intervention) or statin medication only (control). The program aimed to improve adherence to medication and lifestyle by educational material, mailings, and phone calls. Smoking was self-reported at baseline and every 6 months during the 3-year follow-up. Results. In total, 7640 patients were analyzed. At baseline, smoking prevalence was 21.7% in the intervention and 21.5% in the control group. Prevalence decreased in both groups to 16.6% vs. 19.5%, 153% vs. 16.8%, and 14.2% vs. 15.6% at the 12-, 24-, and 36-month follow-up. The intervention had a beneficial effect on smoking differing over time (group x time: P = 0.005). The effect was largest after 6 and 12 months [odds ratios (95% confidence intervals): 0.67 (0.54-0.82) and 0.63 (0.51-0.78)]. The effect decreased until the 18-month follow-up [0.72 (0.58-0.90)] and was not significant after 24 months. Conclusion. A low-intensity smoking intervention embedded in an adherence program can contribute to smoking cessation although the intervention effect diminished over time. (C) 2015 Elsevier Inc. All rights reserved. KW - Smoking KW - Smoking cessation KW - Cardiovascular risk factors KW - Health promotion KW - Randomized controlled trial KW - Multiple risk factor intervention KW - Hypercholesterolemia Y1 - 2015 U6 - https://doi.org/10.1016/j.ypmed.2015.05.026 SN - 0091-7435 SN - 1096-0260 VL - 77 SP - 155 EP - 161 PB - Elsevier CY - San Diego ER - TY - JOUR A1 - Ringwald, Juergen A1 - Lehmann, Marina A1 - Niemeyer, Nicole A1 - Seifert, Isabel A1 - Daubmann, Anne A1 - Wegscheider, Karl A1 - Salzwedel, Annett A1 - Luxembourg, Beate A1 - Eckstein, Reinhold A1 - Völler, Heinz T1 - Travel habits and complications in patients treated with vitamin K antagonists: A cross sectional analysis JF - Travel medicine and infectious disease N2 - Background: Travel-related conditions have impact on the quality of oral anticoagulation therapy (OAT) with vitamin K-antagonists. No predictors for travel activity and for travel-associated haemorrhage or thromboembolic complications of patients on OAT are known. Methods: A standardised questionnaire was sent to 2500 patients on long-term OAT in Austria, Switzerland and Germany. 997 questionnaires were received (responder rate 39.9%). Ordinal or logistic regression models with travel activity before and after onset of OAT or travel-associated haemorrhages and thromboembolic complications as outcome measures were applied. Results: 43.4% changed travel habits since onset of OAT with 24.9% and 18.5% reporting decreased or increased travel activity, respectively. Long-distance worldwide before OAT or having suffered from thromboembolic complications was associated with reduced travel activity. Increased travel activity was associated with more intensive travel experience, increased duration of OAT, higher education, or performing patient self-management (PSM). Travel-associated haemorrhages or thromboennbolic complications were reported by 6.5% and 0.9% of the patients, respectively. Former thromboennbolic complications, former bleedings and PSM were significant predictors of travel-associated complications. Conclusions: OAT also increases travel intensity. Specific medical advice prior travelling to prevent complications should be given especially to patients with former bleedings or thromboennbolic complications and to those performing PSM. (C) 2014 Elsevier Ltd. All rights reserved. KW - Vitamin k-antagonists KW - Oral anticoagulation KW - Travel KW - Patient self-management Y1 - 2014 U6 - https://doi.org/10.1016/j.tmaid.2014.02.006 SN - 1477-8939 SN - 1873-0442 VL - 12 IS - 3 SP - 258 EP - 263 PB - Elsevier CY - Oxford ER -