Lifestyle Walking Intervention for Patients With Heart Failure With Reduced Ejection Fraction: The WATCHFUL Trial.

BACKGROUND: Physical activity is pivotal in managing heart failure with reduced ejection fraction, and walking integrated into daily life is an especially suitable form of physical activity. This study aimed to determine whether a 6-month lifestyle walking intervention combining self-monitoring and regular telephone counseling improves functional capacity assessed by the 6-minute walk test (6MWT) in patients with stable heart failure with reduced ejection fraction compared with usual care. METHODS: The WATCHFUL trial (Pedometer-Based Walking Intervention in Patients With Chronic Heart Failure With Reduced Ejection Fraction) was a 6-month multicenter, parallel-group randomized controlled trial recruiting patients with heart failure with reduced ejection fraction from 6 cardiovascular centers in the Czech Republic. Eligible participants were ≥18 years of age, had left ventricular ejection fraction <40%, and had New York Heart Association class II or III symptoms on guidelines-recommended medication. Individuals exceeding 450 meters on the baseline 6MWT were excluded. Patients in the intervention group were equipped with a Garmin vívofit activity tracker and received monthly telephone counseling from research nurses who encouraged them to use behavior change techniques such as self-monitoring, goal-setting, and action planning to increase their daily step count. The patients in the control group continued usual care. The primary outcome was the between-group difference in the distance walked during the 6MWT at 6 months. Secondary outcomes included daily step count and minutes of moderate to vigorous physical activity as measured by the hip-worn Actigraph wGT3X-BT accelerometer, NT-proBNP (N-terminal pro-B-type natriuretic peptide) and high-sensitivity C-reactive protein biomarkers, ejection fraction, anthropometric measures, depression score, self-efficacy, quality of life, and survival risk score. The primary analysis was conducted by intention to treat. RESULTS: Of 218 screened patients, 202 were randomized (mean age, 65 years; 22.8% female; 90.6% New York Heart Association class II; median left ventricular ejection fraction, 32.5%; median 6MWT, 385 meters; average 5071 steps/day; average 10.9 minutes of moderate to vigorous physical activity per day). At 6 months, no between-group differences were detected in the 6MWT (mean 7.4 meters [95% CI, -8.0 to 22.7]; P=0.345, n=186). The intervention group increased their average daily step count by 1420 (95% CI, 749 to 2091) and daily minutes of moderate to vigorous physical activity by 8.2 (95% CI, 3.0 to 13.3) over the control group. No between-group differences were detected for any other secondary outcomes. CONCLUSIONS: Whereas the lifestyle intervention in patients with heart failure with reduced ejection fraction improved daily steps by about 25%, it failed to demonstrate a corresponding improvement in functional capacity. Further research is needed to understand the lack of association between increased physical activity and functional outcomes. REGISTRATION: URL: https://www.clinicaltrials.gov; Unique identifier: NCT03041610.

Detection and Parameter Estimation Analysis of Binary Shift Keying Signals in High Noise Environments.

In this paper, a new method for detecting and estimating the parameters of a binary phase shift keying (BPSK) signal, based on a cross-correlation function, is proposed. The proposed method consists of two stages. The first stage is used to detect or estimate a signal carrier frequency, and the second stage is used to estimate its pulse width or symbol rate. Firstly, the proposed method is investigated by use of a simulated BPSK signal in the form of Barker Codes 7, 11, and 13 in the MATLAB environment. Based on the simulation results, the functionality of this method is verified using a real-time BPSK signal generated by an E8267C generator. This is described in the second part of this paper. The experimental test results confirm that the proposed method is able to detect and estimate the parameters of all BPSK signals with SNR≥−21 dB.

Patient perceptions of anticoagulant treatment with dabigatran or a vitamin K antagonist for stroke prevention in atrial fibrillation according to region and age: an exploratory analysis from the RE-SONANCE study.

BACKGROUND: The oral anticoagulant dabigatran offers an effective alternative to vitamin K antagonists (VKAs) for stroke prevention in atrial fibrillation (AF), yet patient preference data are limited. The prospective observational RE-SONANCE study demonstrated that patients with AF, newly initiated on dabigatran, or switching to dabigatran from long-term VKA therapy, reported improved treatment convenience and satisfaction compared with VKA therapy. This pre-specified sub-study aimed to assess the impact of country and age on patients' perceptions of dabigatran or VKA therapy in AF. METHODS: RE-SONANCE was an observational, prospective, multi-national study (NCT02684981) that assessed treatment satisfaction and convenience in patients switching from VKAs to dabigatran (Cohort A), or newly diagnosed with AF receiving dabigatran or VKAs (Cohort B), using the PACT-Q questionnaire. Pre-specified exploratory outcomes: variation in PACT-Q2 scores by country and age (< 65, 65 to < 75, ≥ 75 years) (both cohorts); variation in PACT-Q1 responses at baseline by country and age (Cohort B). RESULTS: Patients from 12 countries (Europe/Israel) were enrolled in Cohort A (n = 4103) or B (n = 5369). In Cohort A, mean (standard deviation) PACT-Q2 score increase was highest in Romania (convenience: 29.6 [23.6]) and Hungary (satisfaction: 26.0 [21.4]) (p < 0.001). In Cohort B, mean (standard error) increase in PACT-Q2 scores between dabigatran and VKAs was highest in Romania (visit 3: 29.0 [1.3]; 24.5 [0.9], p < 0.001). Mean PACT-Q2 score increase by age (all p < 0.001) was similar across ages. PACT-Q1 responses revealed lowest expectations of treatment success in Romania and greatest concerns about payment in Estonia, Latvia, and Romania, but were similar across ages. CONCLUSIONS: Treatment satisfaction and convenience tended to favor dabigatran over VKAs. Regional differences in treatment expectations exist across Europe. TRIAL AND CLINICAL REGISTRY: Trial registration number: ClinicalTrials.gov NCT02684981. Trial registration date: February 18, 2016.

Radar Position Estimation by Sequential Irradiation of ESM Receivers.

In this article, a new technique for determination of 2D signal source (target) position is proposed. This novel approach, called the Inscribed Angle (InA), is based on measuring the time difference of sequential irradiation by the main beam of the target antenna's radiation pattern, using Electronic Support Measures (ESM) receivers, assuming that the target antenna is rotating and that its angular velocity is constant. In addition, it is also assumed that the localization system operates in a LOS (Line of Sight) situation and that three time-synchronized sensors are placed arbitrarily across the area. The main contribution of the article is a complete description of the proposed localization method. That is, this paper demonstrates a geometric representation and an InA localization technique model. Analysis of the method's accuracy is also demonstrated. The time of irradiation of the receiving station corresponds to the direction in which the maximum received signal strength (RSS) was measured. In order to achieve a certain degree of accuracy of the proposed positioning technique, a method was derived to increase the accuracy of the irradiation time estimation. Finally, extensive simulation was conducted to demonstrate the performance and accuracy of our positioning method.

Expert consensus on the practical aspects of the cooperation of cardiologist and diabetologist in the management of the patients with chronic heart failure and reduced ejection fraction.

Diabetes mellitus is an important risk factor for the development of heart failure and presence of diabetes significantly worsens heart failure outcome. Introduction of gliflozins to the therapy of heart failure is one of the most important novelty. Gliflozins reduce glucose level by the sodium-glucose contransporter 2 inhibition in proximal tubulus in the kidney. Gliflozins are used as effective antidiabetic drugs with improvement of glycemic control without risk of hypoglycemia, gliflozins decrease blood pressure and patients weight. Recent studies have shown that gliflozins significantly reduce risk of cardiovascular complications and heart failure hospitalizations in diabetic patients. Clinical trials with dapagliflozin and empagliflozin have shown reduction of the risk of cardiovascular death and heart failure hospitalization in the patients with heart failure and reduced ejection fraction both in the patients with diabetes and in the patients without diabetes. The aim of the expert consenzus is to summarize practical aspects in the cooperation of cardiologist and diabetologist in the management of the patients with heart failure and reduced ejection fraction in the context of the current guidelines and other treatment options.

The Power Gain Difference Method Analysis.

In this paper, we propose a new approach to passively locate the 3D position of a signal source. This novel technique, called the power gain difference (PGD), is based only on measuring the received signal strength (RSS) with multiple sensors deployed in the area of interest, while the target transmit power or the equivalent isotropic radiated power (EIRP) is assumed to be unknown. Next, the signal source position is estimated using the knowledge of the ratios of RSS measured on different sensors. First, this article presents the geometric representation and the analytical solution of the model of the PGD technique. Second, the PGD dilution of precision was analyzed in order to gauge the accuracy of measuring the RSS. Finally, a numerical simulation of the performance of the proposed method was carried out and the results are discussed. It seems that the PGD technique has the potential to be a simple and effective solution of the 3D localization problem.

Spironolactone in the treatment of hypertension: a neglected molecule.

Spironolactone, a mineralocorticoid receptor antagonist, is used in the treatment of hypertension for over 50 years. Due to the absence of morbidity and mortality studies, it is not considered to be a first-choice drug in the treatment of patients with primary hyperaldosteronism. However, it has a secure and stable position in the treatment of resistant hypertension. The effect of spironolactone on blood pressure lowering in antihypertensive combination therapy was demonstrated in several uncontrolled trials. The analysis of ASCOTBPLA study also contributed significantly to this area. In the last 10 years, the higher antihypertensive effect of spironolactone compared to placebo (ASPIRANT) and other antihypertensive drugs (PATHWAY-2) was proved in several randomized studies. The outcomes of morbidity and mortality studies in patients with chronic heart failure are also important for the clinical use of spironolactone in patients with hypertension - spironolactone reduces morbidity and mortality in patients with reduced ejection fraction and morbidity only in patients with normal ejection fraction. The outcomes of above-mentioned clinical studies are reflected in current guidelines in which spironolactone has an indisputable role in the treatment of resistant hypertension, primary hyperaldosteronism, and heart failure with reduced ejection fraction. Key words: current guidelines - heart failure - hypertension - resistant hypertension - spironolactone.

New technique of immediate nipple reconstruction during immediate autologous DIEP or MS-TRAM breast reconstruction.

BACKGROUND: Reconstruction of the nipple-areola complex is the final step in surgical restoration of the breast. Usually considered a secondary complement to breast reconstruction, nipple-areola creation is ordinarily done after an interval of several months using different techniques involving local flaps or composite graft from the opposite nipple. METHODS: Because the position of the nipple-areola complex is well defined from the outset in skin-sparing mastectomy, the authors propose a new technique of immediate nipple reconstruction using the skin envelope after skin-sparing mastectomy. A modified wise pattern design of skin-sparing mastectomy with 3 local flaps is used. The dermal-fat flaps are lifted and sutured together to form the new nipple. RESULTS: Seventeen patients (average age, 47 years; range, 33-58 years) underwent immediate nipple reconstruction between March 2010 and January 2012 (11 bilateral and 6 unilateral cases). Average follow-up was 13 months (range, 2-25 months). Aesthetic results were evaluated retrospectively from photographic documentation. A minimum average score of 7.2 points was achieved in all evaluated criteria using a 10-point scale. Patient satisfaction with nipple reconstruction was studied by means of a questionnaire. The shape of the nipple received an average of 9.7 points and the position of the nipple 9.9 points on the 10-point scale; 77% of patients were also very satisfied with nipple sensitivity. CONCLUSIONS: One-stage nipple reconstruction with immediate breast reconstruction using our technique of 3 local flaps on skin envelope flap is possible. This simple, reliable, and rapid technique gives stable aesthetic results over time. Reconstruction may be completed sooner and with fewer procedures. Nipple reconstruction should no longer be considered as a secondary complement to immediate breast reconstruction using deep inferior epigastric perforator or muscle-sparing transverse rectus abdominis myocutaneous flap. Our technique is suitable for patients with ptotic or hypertrophic breasts.

Reconstruction of a Nose Bitten and Eaten by a Dog: A Ten-Year Follow-up of a Bitten-Off Nose Replantation Performed on an Eleven-Year-Old Boy.

The nose is one of the most important aesthetic units of the face. After a traumatic amputation, replantation is undoubtedly the procedure of choice, although, technically, very challenging. We report the 10-year follow-up of a partially digested nose replantation after a dog-bite in an 11-year-old boy using supermicrosurgery technique. Our report confirms that the microsurgical replantation of the nose can lead to an acceptable aesthetic result, with the sufficient growth of the replanted part in the following years. Besides the patient did not report sensibility disorders. The nose replantation in our opinion is the best reconstructive option to achieve an optimal aesthetic and functional outcome.

Surgeon-conducted color Doppler ultrasound deep inferior epigastric artery perforator mapping: A cohort study and learning curve assessment.

BACKGROUND: Perforator mapping using diagnostic methods facilitates deep inferior epigastric perforator (DIEP) flap planning. Computed tomographic angiography (CTA) is a well-proven tool for perforator mapping. However, the benefits of color Doppler ultrasonography (CDU) are as follows: 1) CDU involves dynamic real-time examination and 2) does not use radiation. Comparing the accuracies of both methods in a cohort of patients, this study aimed to evaluate the learning curve of surgeon-conducted CDU perforator mapping. METHODS: Twenty patients undergoing DIEP flap breast reconstruction were enrolled in a cohort study. All patients underwent CTA perforator mapping preoperatively. XY coordinates of significant perforators were subtracted by a radiologist. A single surgeon (sonographer) with minimal experience with CDU performed CDU perforator mapping, including XY coordinates subtraction. The sonographer was blinded to the CTA data. The reference coordinates of dissected perforators were measured during surgery. Deviations from reference coordinates for both methods were compared, and CDU mapping learning curve was assessed using Joinpoint Regression. RESULTS: We included 20 women (32 DIEP flaps and 59 dissected perforators). The mean deviation between mapped and reference coordinates was 1.00 (0.50-1.12) cm for CDU and 0.71 (0.50-1.12) cm for CTA. The learning curve of CDU mapping showed the breaking point after the seventh patient (≈ 21 localized perforators). After the breaking point, no significant differences between the deviations of both methods were found (p = 0.980). CONCLUSION: A limited number of examinations were needed for the surgeon to learn CDU DIEA perforator mapping with accuracy similar to that of CTA mapping.

Statistical analysis plan for a randomized controlled trial examining pedometer-based walking intervention in patients with heart failure with reduced ejection fraction: the WATCHFUL trial.

BACKGROUND: Physical activity is an effective management strategy for heart failure with reduced ejection fraction, but patients' compliance is challenging. Walking is a suitable form of physical activity due to its convenience and sustainability, and it can potentially improve functional capacity in heart failure patients. OBJECTIVES: The WATCHFUL trial aims to determine whether a pedometer-based walking intervention combined with face-to-face sessions and regular telephone contact improves functional capacity in heart failure patients. METHODS: The WATCHFUL trial is a 6-month multicenter, parallel-group, randomized, controlled, superiority trial with a 6-month follow-up. A total of 202 patients were recruited for the trial. The primary analysis will evaluate the change in distance walked during the 6-min walk test from baseline to 6 months based on the intention-to-treat population; the analysis will be performed using a linear mixed-effect model adjusted for baseline values. Missing data will be imputed using multiple imputations, and the impact of missing data will be assessed using a sensitivity analysis. Adverse events are monitored and recorded throughout the trial period. DISCUSSION: The trial has been designed as a pragmatic trial with a scalable intervention that could be easily translated into routine clinical care. The trial has been affected by the COVID-19 pandemic, which slowed patients' recruitment and impacted their physical activity patterns. CONCLUSIONS: The present publication provides details of the planned statistical analyses for the WATCHFUL trial to reduce the risks of reporting bias and erroneous data-driven results. TRIAL REGISTRATION: ClinicalTrials.gov (identifier: NCT03041610, registered: 3/2/2017).

The detrimental effect of COVID-19 nationwide quarantine on accelerometer-assessed physical activity of heart failure patients.

AIMS: A reduction of habitual physical activity due to prolonged COVID-19 quarantine can have serious consequences for patients with cardiovascular diseases, such as heart failure. This study aimed to explore the effect of COVID-19 nationwide quarantine on accelerometer-assessed physical activity of heart failure patients. METHODS AND RESULTS: We analysed the daily number of steps in 26 heart failure patients during a 6-week period that included 3 weeks immediately preceding the onset of the quarantine and the first 3 weeks of the quarantine. The daily number of steps was assessed using a wrist-worn accelerometer worn by the patients as part of an ongoing randomized controlled trial. Multilevel modelling was used to explore the effect of the quarantine on the daily step count adjusted for weather conditions. As compared with the 3 weeks before the onset of the quarantine, the step count was significantly lower during each of the first 3 weeks of the quarantine (P < 0.05). When the daily step count was averaged across the 3 weeks before and during the quarantine, the decrease amounted to 1134 (SE 189) steps per day (P < 0.001), which translated to a 16.2% decrease. CONCLUSIONS: The introduction of the nationwide quarantine due to COVID-19 had a detrimental effect on the level of habitual physical activity in heart failure patients, leading to an abrupt decrease of daily step count that lasted for at least the 3-week study period. Staying active and maintaining sufficient levels of physical activity during the COVID-19 pandemic are essential despite the unfavourable circumstances of quarantine.

Patient perception of anticoagulant treatment for stroke prevention (RE-SONANCE study).

Objective: We evaluated atrial fibrillation (AF) patients' perceptions of anticoagulation treatment with dabigatran or a vitamin K antagonist (VKA) for stroke prevention, according to accepted indications. Methods: The RE-SONANCE observational, prospective, multicentre, international study used the validated Perception on Anticoagulant Treatment Questionnaire (PACT-Q) to assess patients with AF already taking a VKA who were switched to dabigatran (cohort A), and newly diagnosed patients initiated on either dabigatran or a VKA (cohort B). Visit 1 (V1) was at baseline, and visit 2 (V2) and visit 3 (V3) were at 30-45 and 150-210 days after baseline, respectively. Primary outcomes were treatment satisfaction and convenience in cohort A at V2 and V3 versus baseline, and in cohort B for dabigatran and a VKA at V2 and V3. Results: The main analysis set comprised 4100 patients in cohort A and 5365 in cohort B (dabigatran: 3179; VKA: 2186). In cohort A, PACT-Q2 improved significantly (p<0.001 for all) for treatment convenience (mean change V1 vs V2=20.72; SD=21.50; V1 vs V3=24.54; SD=22.85) and treatment satisfaction (mean change V1 vs V2=17.60; SD=18.76; V1 vs V3=21.04; SD=20.24). In cohort B, mean PACT-Q2 scores at V2 and V3 were significantly higher (p<0.001 for all) for dabigatran versus a VKA for treatment convenience (V2=18.38; SE =0.51; V3=23.34; SE=0.51) and satisfaction (V2=15.88; SE=0.39; V3=19.01; SE=0.41). Conclusions: Switching to dabigatran from long-term VKA therapy or newly initiated dabigatran is associated with improved patient treatment convenience and satisfaction compared with VKA therapy.

A Comprehensive In Vitro Comparison of Preparation Techniques for Fat Grafting.

BACKGROUND: Lipomodeling is a technique that uses the patient's own fat for tissue regeneration and augmentation. The extent of regenerative effect is reported to be determined by the numbers of adipose-derived stem cells and the viability of cells in processed adipose tissue which, together with other factors, influence the degree of graft retention. This study addresses whether differences exist in properties of fat graft obtained by three commonly used techniques. METHODS: Adipose tissue harvested from the hypogastric regions of 14 patients was processed by decantation, centrifugation, and membrane-based tissue filtration. The morphology of each preparation was assessed by electron microscopy and overall cell viability was assessed by live/dead assay. The number of adipose-derived stem cells was determined and their stem cell character was assessed by the presence of cell surface molecules (i.e., CD105, CD90, CD31, and CD45) and by their capacity to differentiate into adipogenic and osteogenic lineages. RESULTS: First, morphologies of processed fat samples obtained by individual procedures differed, but no preparation caused obvious damage to cellular or acellular components. Second, although the highest numbers of adipose-derived stem cells were contained in the upper fraction of centrifuged lipoaspirates, the difference between preparations was marginal. Third, the maximal concentration of adipose fraction (removal of watery component) of lipoaspirate was achieved by membrane-based tissue filtration. Finally, no significant differences in overall viability were detected. CONCLUSIONS: Properties of processed lipoaspirate were influenced by the preparation procedure. However, the differences were not dramatic; both centrifugation and membrane-based filtration are methods of choice whose selection depends on other criteria (e.g., practicality) for individual surgical settings.

Vasospasm of the flap pedicle: the effect of 11 of the most often used vasodilating drugs. Comparative study in a rat model.

BACKGROUND: There has been no review study published yet comparing the effects of the vasodilating drugs that are most often used in clinical practice empirically. The aim of the authors' study was to perform this comparison and to select the drugs that are able to release vasospasm and the drugs that reduce vasospasm duration most effectively in an experimental model in vivo. METHODS: Pedicled groin flaps were dissected in 300 male Wistar rats. Vasospasm was induced by tension applied on the pedicle in the axial direction using a 15-g weight. The blood perfusion of the flap was monitored using a laser Doppler device. The duration of vasospasm was defined as the time from the release of tension until blood flow began to rise. These times were detected using automated computerized detection. The effects of 11 different drugs were studied in 14 groups. The drugs were applied locally; some of them were tested in different concentrations or applied parenterally. RESULTS: Ten percent magnesium sulfate reduced the duration of vasospasm most effectively (p < 0.01). Verapamil applied locally and also pentoxifylline applied parenterally were also very effective. In contrast, the duration of vasospasm was extended after local application of 2% lidocaine (p < 0.01). CONCLUSIONS: The authors concluded that 10% magnesium sulfate applied locally has the best ability to relieve surgically induced vasospasm because of the highest level of significance and reliability. The finding that local application of 2% lidocaine prolongs vasospasm may be surprising.

Pectoral muscle flap with V-Y skin paddle for covering sternal defects.

Deep sternal wound infection (DSWI) after a cardiac operation is a rare but serious complication associated with significant morbidity and mortality. It can lead to wound dehiscence with sternal osteomyelitis and both bony and soft tissue residual defects. When the infection is eradicated, reconstruction of the thoracic wall remains the main challenge. Tissue used for covering the defect must be well nourished and sutures must be tension free. We present our unique modification of the method using the pectoral muscle axial flap with a V-Y skin paddle.

Bilateral breast reconstruction with DIEP flaps: 4 years' experience.

UNLABELLED: Bilateral prophylactic mastectomy without reconstruction is not accepted by the majority of patients. Successful reconstruction is therefore a mandatory condition for prophylactic mastectomy. Of the many options for autologous breast reconstruction, the deep inferior epigastric perforator (DIEP) flap best meets requirements for bilateral reconstruction in selected patients. The goal of this study is to verify the feasibility of the procedure in our conditions and to find out how it is accepted by patients. We present 55 consecutive patients who were scheduled for bilateral DIEP flap reconstruction during a 4-year period. We reviewed medical charts, performed clinical assessments and processed anonymous questionnaires. There were 77 immediate and 33 delayed breast reconstructions. There was 100% flap survival and no microanastomoses revisions. In 11 patients (10%) the surgeon preferred to convert the DIEP into a mini transverse rectus abdominis muscle (miniTRAM) flap in order to provide adequate blood supply. COMPLICATIONS: revision for haematoma under the flap in four patients (7.2%), excessive blood loss in four patients (7.2%) and partial mastectomy skin flap necrosis in 10 immediate breast reconstructions (12.9%). Patients' evaluation of the aesthetic result was good or excellent in 96.2% of cases. In 33.9% of patients the postoperative quality of life was considered unchanged and 50.9% of them it even improved. The DIEP flap is recommended for bilateral breast reconstruction. Occasional conversion into a miniTRAM flap can increase the total flap survival rate. Bilateral prophylactic mastectomy and DIEP flap reconstruction are very well accepted by patients.

Primary vein grafting in treatment of ring avulsion injuries: a 5-year prospective study.

Out of 262 hands with total finger amputations treated by replantation of finger/fingers from January 2001 until January 2006, there were only 6 cases of type III ring avulsion injuries, all of which were replanted. Radical resection of the damaged part of the artery with primary vein grafting was used in each case; only 1 artery and 2 veins were anastomosed for each finger. The survival rate was 100%. Mean total active motion was 195 degrees (ranging from 175 degrees to 220 degrees ). Mean 2-point discrimination was 8.6 mm static (ranging from 4 to 11 mm) and 6.2 mm moving (ranging from 3 to 9 mm), and mean grip strength was 37.4 kg. We believe that liberal resection of the "zone of contusion" of vessels and primary vein grafting for arterial repair can improve the overall survival rate of replantation in type III ring avulsion injuries, and replantation can be attempted in majority of the cases; good hand function can be expected.