Symptomatic Episodes Research Articles

Characteristics of symptomatic reflux episodes in Japanese proton pump inhibitor-refractory non-erosive reflux disease patients.

To clarify the pathogenesis of gastroesophageal reflux disease symptoms in non-erosive reflux disease (NERD) patients. Thirty-five NERD patients with persistent symptoms, despite taking rabeprazole 10 mg twice daily for at least 8 wk, were included in this study. All patients underwent 24 h combined impedance - pH on rabeprazole. The symptom index (SI) was considered to be positive if ≥ 50%, and proximal reflux episodes were determined when reflux reached 15 cm above the proximal margin of the lower esophageal sphincter. In 14 (40%) SI-positive patients, with liquid weakly acid reflux, the occurrence rate of reflux symptoms was significantly more frequent in proximal reflux episodes (46.7%) than in distal ones (5.7%) (P < 0.001). With liquid acid reflux, there were no significant differences in the occurrence rate of reflux symptoms between proximal reflux episodes (38.5%) and distal ones (20.5%) (NS). With mixed liquid-gas weakly acid reflux, the occurrence rate of reflux symptoms in proximal reflux episodes was significantly more frequent (31.0%) than in distal reflux ones (3.3%) (P < 0.001). With mixed liquid-gas acid reflux, there were no significant differences in the occurrence rate of reflux symptoms between proximal reflux episodes (29.4%) and distal ones (14.3%) (NS). The proximal extent of weakly acidic liquid and mixed liquid-gas reflux is a major factor associated with reflux perception in SI-positive patients on proton pump inhibitor therapy.

Use of human insulin analogues in young patients with type 1 diabetes mellitus: Results of the RESULT observational program on the use of insulin glargine (Lantus) in combination with insulin glulisine (Apidra) as a basal-bolus regimen

To implement in 2009-2012 the RESULT observational program on the use of insulin glargine (Lantus) in combination with insulin glulisine (Apidra) as a basal-bolus regimen in patients with type 1 diabetes mellitus (DM) to evaluate the efficiency and safety of therapy with human insulin analogues. The program covered 100 patients aged 19 to 25 years from 7 regions of the Russian Federation, who had had DM onset at the age of 9-13 years, were using human recombinant insulins as continuous insulin therapy, and had glycated hemoglobin (HbA1c) levels of 7 to 9%. The main inclusion criterion was switching to insulin therapy with the human insulin analogues Lantus and Apidra. A total 41 men and 59 women were followed up. Their mean baseline HbA1c level was 8.3±0.7%. After 24 months of therapy, HbA1c was significantly decreased to 7.7±0.7%; its change compared with that at Visit 1 was -0.6±0.6% (p<0.001). There was a significant reduction in fasting and postprandial blood glucose levels at 3 months of a follow-up. The number of symptomatic and asymptomatic glycemic episodes declined. No nocturnal or severe hypoglycemic episodes were recorded at 24 months of therapy. Microvascular complications did not progress during the follow-up. The use of human insulin analogues is effective and safe in treating young diabetic patients, improves their quality of life and confers no risk of asymptomatic or nocturnal hypoglycemic states.

Spontaneous Internal Carotid Dissection in a 38 Year Old Female: A Case Report

This case describes a patient with amaurosis fugax as a result of non-traumatic internal carotid dissection. Typical symptoms of monocular blindness, especially in the setting of headache or neck pain should prompt evaluation for carotid dissection. Initial presentation with transient vision loss, lasting thirty minutes with a normal ophthalmic exam should raise suspicion for transient ischemic attack as well as carotid dissection. Symptoms may progress with resultant cerebral infarction as the dissection progresses. Carotid ultrasound with notable decreased internal carotid artery velocity prompts CT angiography of the neck confirming the carotid dissection. Anti-platelet therapy is the first line treatment, with anticoagulation reserved for cases of recurrent, progressive symptomatic episodes.

Single 3-minute freeze for second-generation cryoballoon ablation: one-year follow-up after pulmonary vein isolation.

The second-generation cryoballoon (CB-Adv) is effective in achieving pulmonary vein isolation (PVI) with encouraging results. The mid-term clinical efficacy of a single 3-minute freeze, without a routine bonus application, has been recently demonstrated. The purpose of this study was to assess long-term clinical outcome after PVI with the CB-Adv using a single 3-minute application. A total of 143 consecutive patients (93 male [65%], mean age 59.6 ± 12.0 years) with paroxysmal atrial fibrillation (PAF; 113/143 [79%]) or early persistent atrial fibrillation (AF; 30/143 [21%]) underwent PVI using CB-Adv with a single 3-minute freeze. Atrial tachyarrhythmia recurrences were defined as symptomatic or documented episodes >30 seconds. After a single freeze, isolation could be reached in 94.1% of all identified pulmonary veins. Complete PVI was successfully achieved with 1.1 ± 0.4 mean freezes. Persistent phrenic nerve palsy occurred in 5 of 143 patients (3.5%). At a mean 12.1 ± 4.4 months of follow-up, after a 3-month blanking period (BP), 80.4% (115/143) were in stable sinus rhythm (93/113 [82.3%] for PAF; 22/30 [73.3%] for early persistent AF). Fifteen patients underwent a second procedure with radiofrequency ablation showing reconnection in 7 of 15 right-sided (46.7%) and 6 of 15 left-sided (40%) pulmonary veins. Relapses during BP (P <.01), time to PVI (P = .02), and longer AF duration (P = .04) were independent predictors of recurrences. A single 3-minute freeze is highly effective, determining an atrial tachyarrhythmia freedom of 80.4% at 1-year follow-up. The incidence of persistent phrenic nerve palsy is 3.5%. Relapses during BP, time to PVI, and longer AF duration are predictors of recurrences. Routine use of an "insurance freeze" may not be needed.

Accessory atrioventricular pathways refractory to catheter ablation: role of percutaneous epicardial approach.

Epicardial mapping and ablation of accessory pathways through a subxiphoid approach can be an alternative when endocardial or epicardial transvenous mapping has failed. We reviewed acute and long-term follow-up of 21 patients (14 males) referred for percutaneous epicardial accessory pathway ablation. There was a median of 2 previous failed procedures. All patients were highly symptomatic, 8 had atrial fibrillation (3 with cardiac arrest) and 13 had frequent symptomatic episodes of atrioventricular reentrant tachycardia. Six patients (28.5%) had a successful epicardial ablation. Five patients (23.8%) underwent a successful repeated endocardial mapping, and ablation after epicardial mapping yielded no early activation site. Epicardial mapping was helpful in guiding endocardial ablation in 2 patients (9.5%), showing that the earliest activation was simultaneous at the epicardium and endocardium. Four patients (19%) underwent successful open-chest surgery after failing epicardial/endocardial ablation. Two patients (9.5%) remained controlled under antiarrhythmic drugs after unsuccessful endocardial/epicardial ablation. Two patients had a coronary sinus diverticulum and one a right atrium to right ventricle diverticulum. Three patients acquired postablation coronary sinus stenosis. There was no major complication related to pericardial access. Percutaneous epicardial approach is an alternative when conventional endocardial or transvenous epicardial ablation fails in the elimination of the accessory pathway. A new attempt by endocardial approach was successful in a significant number of patients. Open-chest surgery may be required in symptomatic cases refractory to endocardial-epicardial approach.

The Risk Paradox: Use of Elective Cholecystectomy in Older Patients Is Independent of Their Risk of Developing Complications

We recently developed and validated a prognostic model that accurately predicts the 2-year risk of emergent gallstone-related hospitalization in older patients presenting with symptomatic gallstones. We used 100% Texas Medicare data (2000 to 2011) to identify patients aged 66 years and older with an initial episode of symptomatic gallstones not requiring emergency hospitalization. At presentation, we calculated each patient's risk of 2-year gallstone-related emergent hospitalization using the previously validated model. Patients were placed into the following risk groups based on model estimates: <30%, 30% to <60%, and ≥ 60%. Within each risk group, we calculated the percent of elective cholecystectomies (≤ 2.5 months from initial episode) performed. In all, 161,568 patients had an episode of symptomatic gallstones. Mean age was 76.5 ± 7.3 years and 59.9% were female. The 2-year risk of gallstone-related hospitalizations increased from 15.9% to 41.5% to 65.2% across risk groups. For the overall cohort, 22.3% in the low-risk group, 20.9% in the moderate-risk group, and 23.2% in the high-risk group underwent elective cholecystectomy in the 2.5 months after the initial symptomatic episode. In patients with no comorbidities, elective cholecystectomy rates decreased from 34.2% in the low-risk group to 26.7% in the high-risk group. Of patients who did not undergo cholecystectomy, only 9.5% were seen by a surgeon in the 2.5 months after the initial episode. The risk of recurrent acute biliary symptoms requiring hospitalization has no influence, or even a paradoxical negative influence, on the decision to perform elective cholecystectomy after an initial symptomatic episode. Translation of the risk prediction model into clinical practice can better align treatment with risk and improve outcomes in older patients with symptomatic gallstones.

Asymptomatic lone atrial fibrillation - how can we detect the arrhythmia?

Atrial fibrillation (AF) may occur in the absence of identifiable causes, co-morbidities or structural cardiac disease (lone AF). Silent AF is common and patients may have a completely asymptomatic arrhythmia or may experience both symptomatic and asymptomatic AF episodes. It has been estimated that among patients with recognized AF, one third has no appreciable symptoms. In contemporary clinical practice, AF remains largely underdiagnosed and 25% of patients with AF-associated cardioembolic stroke have not been previously diagnosed with AF. The strategies for AF screening include opportunistic and systematic screening. Several methods for AF detection are nowadays available: from very simple (pulse palpation) to more advanced technologies proposed for ambulatory external monitoring of variable time duration. In patients previously implanted with cardiac electrical devices with an atrial lead, according to current clinical indications, the ability to continuously detect AF and to monitor its evolution is magnified, and AF burden can be precisely measured and monitored along with time. Similar information on AF burden can be also obtained by implantation of subcutaneous cardiac monitors that rely on the analysis of consecutive RR intervals for the diagnosis of AF. The prognosis is generally favorable for patients presenting with lone AF, but adverse outcomes, including stroke and thromboembolic events may occur at long term, in association with aging, or the development of underlying heart disease, or progression from paroxysmal to permanent AF. In this respect, the role of new technologies and diagnostic tools for AF detection and monitoring should be fully defined.

Acupuncture points used in the prophylaxis against recurrent uncomplicated cystitis, patterns identified and their possible relationship to physiological measurements.

To explore the correlation between single acupoints used and the recurrence rate of cystitis among cystitis-prone women receiving acupuncture as a prophylactic treatment. In all, 58 cystitis-prone women were included in the analysis. Customised acupuncture treatments were given twice a week, over 4 weeks. The main effect parameter was the number of cystitis episodes during the 6-month observation time. Residual urine was measured at baseline, 2, 4 and 6 months using portable ultrasound equipment. Sympathetic and vagotone nerve activities were measured by using skin conductance and respiratory sinus arrhythmia, respectively. The main acupoints used for patients with Kidney (Shen) qi/yang deficiency were Shenshu (BL23), Taixi (KI3), Zhongji (CV3), Sanyinjiao (SP6) and Pangguangshu (BL28), compared with Taichong (LR3), CV3, BL28, Yinlingquan (SP9) and SP6 for Liver (Gan) qi stagnation, and SP6, CV3, BL28, Zusanli (ST36) and SP9 for Spleen (Pi) qi/yang deficiency patients. The combination BL23 and KI3 were used in 16 women, 13 of which were Kidney pattern related patients. When used, the number of symptomatic episodes were reduced to a third compared with what occurred in the 42 women where this combination was not used (3/16 vs. 28/42, P<0.05). BL23 application correlated to a significant reduction in residual urine measured a few days after treatment. Patients with the pattern of Spleen qi/yang deficiency had an initial increase in residual urine after treatments. Treating Kidney pattern related patients with the combination of BL23 and KI3 resulted in far better outcome than other points/combination of points for other Chinese medicine diagnoses. The acupoint SP6 may be less indicated than previously assumed when treating cystitis-prone women prophylactically.

Ultrafiltration biofeedback guided by blood volume monitoring to reduce intradialytic hypotensive episodes in hemodialysis: study protocol for a randomized controlled trial.

BackgroundFluid removal during dialysis, also known as ultrafiltration (UF), leads to intradialytic hypotension (IDH) in a significant number of patients treated with hemodialysis (HD) and is associated with an increase in morbidity and mortality. At present, there are no accepted standards of practice for the prevention or treatment of IDH. Relative blood volume monitoring (BVM) is based on the concept that the hematocrit increases with UF, relative to the patient’s baseline hematocrit. The use of BVM biofeedback, whereby the HD machine automatically adjusts the rate of UF based on the relative blood volume, has been proposed for the prevention of IDH.Methods/DesignThis is a 22-week randomized crossover trial. Participants undergo a 4-week run-in phase to standardize medications and dialysis prescriptions. Subsequently, participants are randomized to standard HD or to BVM biofeedback for a period of 8 weeks followed by a 2-week washout phase before crossing over. The dialysis prescription remains identical for both arms. The primary outcome is the frequency of symptomatic IDH as defined by an abrupt drop in the systolic blood pressure of ≥20 mm Hg accompanied by headache, dizziness, loss of consciousness, thirst, dyspnea, angina, muscle cramps or vomiting. Secondary outcomes include the number of symptomatic IDH episodes and any reduction in IDH episodes, nursing interventions, dialysis adequacy, total body water, extra- and intracellular fluid volumes, brain natriuretic peptide and cardiac troponin levels, blood pressure, antihypertensive medication use, patient symptoms and quality of life.DiscussionOur study will determine the impact of using BVM biofeedback to prevent IDH and other serious adverse events in susceptible patients.Trial registrationClinicaltrials.gov NCT01988181 (6 November 2013).Electronic supplementary materialThe online version of this article (doi:10.1186/1745-6215-15-483) contains supplementary material, which is available to authorized users.

Green &amp; Healthy Homes Initiative: Improving Health, Economic, and Social Outcomes Through Integrated Housing Intervention

Poor quality housing is an ongoing environmental injustice placing a significant burden on low-income and minority families. The Green & Healthy Homes Initiative (GHHI) in Baltimore, MD, grew out of the historical healthy homes work of the Coalition to End Childhood Lead Poisoning, an organization dedicated to using housing as a platform for health to ensure environmental and social justice for families and children in low-income communities. GHHI's Healthy Homes Demonstration Project utilized the standards and practices created by GHHI: A Holistic Housing Assessment coupled with environmental health education and combined as an integrated environmental health and energy housing intervention for children with asthma, ages 2–14. The project braids resources from healthy homes, lead hazard reduction, weatherization, and energy efficiency projects to form a single multi-component, multi-factorial intervention. Findings from the health surveys at intake and six months after the intervention provide evidence of the impact on the reduction of asthma symptomatic episodes, emergency room visits, and hospitalizations, while showing improvements in school attendance and parents' work attendance. Findings will provide evidence that improved health outcomes and more stable and productive homes in primarily African American, low-income neighborhoods are related to the mitigation of asthma triggers and home-based environmental health hazards. Upstream integrated housing interventions are an effective means to improve health, economic, and social outcomes for children diagnosed with asthma.

The diminishing returns of atovaquone-proguanil for elimination of Plasmodium falciparum malaria: modelling mass drug administration and treatment.

BackgroundArtemisinin resistance is a major threat to current efforts to eliminate Plasmodium falciparum malaria which rely heavily on the continuing efficacy of artemisinin combination therapy (ACT). It has been suggested that ACT should not be used in mass drug administration (MDA) in areas where artemisinin-resistant P. falciparum is prevalent, and that atovaquone-proguanil (A-P) might be a preferable alternative. However, a single point mutation in the cytochrome b gene confers high level resistance to atovaquone, and such mutant parasites arise frequently during treatment making A-P a vulnerable tool for elimination.MethodsA deterministic, population level, mathematical model was developed based on data from Cambodia to explore the possible effects of large-scale use of A-P compared to dihydroartemisinin-piperaquine ACT for mass drug administration and/or treatment of P. falciparum malaria, with and without adjunctive primaquine (PQ) and long-lasting insecticide-treated bed nets (LLIN). The aim was local elimination.ResultsThe model showed the initial efficacy of ACT and A-P for MDA to be similar. However, each round of A-P MDA resulted in rapid acquisition and spread of atovaquone resistance. Even a single round of MDA could compromise efficacy sufficient to preclude its use for treatment or prophylaxis. A switch to A-P for treatment of symptomatic episodes resulted in a complete loss of efficacy in the population within four to five years of its introduction. The impact of MDA was temporary and a combination of maintained high coverage with ACT treatment for symptomatic individuals and LLIN was necessary for elimination.ConclusionFor malaria elimination, A-P for MDA or treatment of symptomatic cases should be avoided. A combined strategy of high coverage with ACT for treatment of symptomatic episodes, LLIN and ACT + P MDA would be preferable.Electronic supplementary materialThe online version of this article (doi:10.1186/1475-2875-13-380) contains supplementary material, which is available to authorized users.

The ROKS nomogram for predicting a second symptomatic stone episode.

Most patients with first-time kidney stones undergo limited evaluations, and few receive preventive therapy. A prediction tool for the risk of a second kidney stone episode is needed to optimize treatment strategies. We identified adult first-time symptomatic stone formers residing in Olmsted County, Minnesota, from 1984 to 2003 and manually reviewed their linked comprehensive medical records through the Rochester Epidemiology Project. Clinical characteristics in the medical record before or up to 90 days after the first stone episode were evaluated as predictors for symptomatic recurrence. A nomogram was developed from a multivariable model based on these characteristics. There were 2239 first-time adult kidney stone formers with evidence of a passed, obstructing, or infected stone causing pain or gross hematuria. Symptomatic recurrence occurred in 707 of these stone formers through 2012 (recurrence rates at 2, 5, 10, and 15 years were 11%, 20%, 31%, and 39%, respectively). A parsimonious model had the following risk factors for recurrence: younger age, male sex, white race, family history of stones, prior asymptomatic stone on imaging, prior suspected stone episode, gross hematuria, nonobstructing (asymptomatic) stone on imaging, symptomatic renal pelvic or lower-pole stone on imaging, no ureterovesicular junction stone on imaging, and uric acid stone composition. Ten-year recurrence rates varied from 12% to 56% between the first and fifth quintiles of nomogram score. The Recurrence of Kidney Stone nomogram identifies kidney stone formers at greatest risk for a second symptomatic episode. Such individuals may benefit from medical intervention and be good candidates for prevention trials.

The Role of Asymptomatic AF on Postablation Outcomes

Atrial fibrillation (AF) is responsible for substantial morbidity, including stroke. While catheter ablation has emerged as an effective treatment for symptomatic AF [Stabile G et al. Eur Heart J 2006], less is known about the incidence of either pre- or postablation asymptomatic AF [Rho RW, Page RL. Prog Cardiovasc Dis 2005]. This article discusses results from the Discerning the Incidence of Symptomatic and Asymptomatic Episodes of Atrial Fibrillation Before and After Catheter Ablation trial [DISCERN AF; Verma A et al. JAMA Intern Med 2013].

Paroxysmal AF Catheter Ablation With a Contact Force Sensing Catheter: Results of the Prospective, Multicenter SMART-AF Trial

BackgroundCatheter ablation is important for treatment of paroxysmal atrial fibrillation (PAF). Limited animal and human studies suggest a correlation between electrode-tissue contact and radiofrequency lesion generation. ObjectivesThe study sought to assess the safety and effectiveness of an irrigated, contact force (CF)-sensing catheter in the treatment of drug refractory symptomatic PAF. MethodsA prospective, multicenter, nonrandomized study was conducted. Enrollment criteria included: ≥3 symptomatic episodes of PAF within 6 months of enrollment and failure of ≥1 antiarrhythmic drug (Class I to IV). Ablation included pulmonary vein isolation with confirmed entrance block as procedural endpoint. ResultsA total of 172 patients were enrolled at 21 sites, where 161 patients had a study catheter inserted and 160 patients underwent radiofrequency application. Procedural-related serious adverse events occurring within 7 days of the procedure included tamponade (n = 4), pericarditis (n = 3), heart block (n = 1, prior to radiofrequency application), and vascular access complications (n = 4). By Kaplan-Meier analyses, 12-month freedom from atrial fibrillation/atrial flutter/atrial tachycardia recurrence was 72.5%. The average CF per procedure was 17.9 ± 9.4 g. When the CF employed was between investigator selected working ranges ≥80% of the time during therapy, outcomes were 4.25 times more likely to be successful (p = 0.0054; 95% confidence interval: 1.53 to 11.79). ConclusionsThe SMART-AF trial demonstrated that this irrigated CF-sensing catheter is safe and effective for the treatment of drug refractory symptomatic PAF, with no unanticipated device-related adverse events. The increased percent of time within investigator-targeted CF ranges correlates with increased freedom from arrhythmia recurrence. Stable CF during radiofrequency application increases the likelihood of 12-month success. (THERMOCOOL® SMARTTOUCH® Catheter for Treatment of Symptomatic Paroxysmal Atrial Fibrillation; NCT01385202)

Clinical complications of urinary catheters caused by crystalline biofilms: something needs to be done

This review is largely based on a previous paper published in the journal Spinal Cord. The care of many patients undergoing long-term bladder catheterization is complicated by encrustation and blockage of their Foley catheters. This problem stems from infection by urease-producing bacteria, particularly Proteus mirabilis. These organisms colonize the catheter forming an extensive biofilm; they also generate ammonia from urea, thus elevating the pH of urine. As the pH rises, crystals of calcium and magnesium phosphates precipitate in the urine and in the catheter biofilm. The continued development of this crystalline biofilm blocks the flow of urine through the catheter. Urine then either leaks along the outside of the catheter and the patient becomes incontinent or is retained causing painful distension of the bladder and reflux of urine to the kidneys. The process of crystal deposition can also initiate stone formation. Most patients suffering from recurrent catheter encrustation develop bladder stones. P.mirabilis establishes stable residence in these stones and is extremely difficult to eliminate from the catheterized urinary tract by antibiotic therapy. If blocked catheters are not identified and changed, serious symptomatic episodes of pyelonephritis, septicaemia and endotoxic shock can result. All types of Foley catheters including silver- or nitrofurazone-coated devices are vulnerable to this problem. In this review, the ways in which biofilm formation on Foley catheters is initiated by P.mirabilis will be described. The implications of understanding these mechanisms for the development of an encrustation-resistant catheter will be discussed. Finally, the way forward for the prevention and control of this problem will be considered.

Pseudotumoral Forms of Multiple Sclerosis: Report of 14 Cases and Review of the Literature

Background: The pseudotumoral form of multiple sclerosis (MS) is a rare condition with few descriptions in the literature. It supposes a diagnostic challenge especially when appearing at the onset of disease. Methods: We retrospectively describe a case series of pseudotumoral MS patients that attended our hospital from 2004, analyzing demographic, clinical and radiological variables. We classified the lesions according to the recently proposed morphologic classification (infiltrative, megacystic, Baló or ring-like) and according to the contrast enhancement pattern (nodular, complete ring, incomplete ring and diffuse). Results: Fourteen patients (11 female, 3 male), with a mean age of 35 years, were identified. All of them suffered from a relapsing-remitting form of MS. Eleven patients (78.57%) had symptomatic pseudotumoral lesions (PL), being the form of clinical presentation in the majority of those patients that were symptomatic (81.81%). Several patients presented atypical clinical manifestations such as cognitive impairment (21.42%) and epileptic seizures (14.28%). Full recovery was found in 53.84% of all symptomatic episodes. After a mean follow-up of 43 months, recurrent PL episodes were seldom observed (21.42%), the annualized relapse rate was 0.95 and the mean final Expanded Disability Status Scale score was 1.5. The majority of PLs were supratentorial, coexisted with typical demyelinating plaques and showed the ring-like morphology and the ring pattern of contrast enhancement. Three patients had more than one PL on the same scan, all of the lesions with similar morphology. Conclusions: Our findings contribute to a better characterization of pseudotumoral forms of MS. However, larger studies are required to define this atypical entity more exactly.

Decrease in clinical hypoglycemia in young children with type 1 diabetes treated with free-mixed aspart and detemir insulin: an open labeled randomized trial.

To compare the effectiveness of a free-mix of aspart (A) and detemir (D) insulins (ADIM) with a commonly used premixed fixed-ratio aspart and neutral protamine Hagedorn (NPH) insulin mixture (ANIM) in young children with type 1 diabetes (T1D) treated with twice-daily injections. The trial thus compares not only D vs. NPH, but also flexible, personalized insulin preparations vs. a fixed premixed preparation. This single-center, open-label, randomized trial included 82 children with T1D. Patients stayed on ANIM for 1 yr of optimization of disease management, then were randomized to either ANIM (N = 41) or ADIM (N = 41) for another year. Frequency of severe or symptomatic episodes, glycated hemoglobin A1c (HbA1c), and blood glucose (BG) values. Compared with ANIM, ADIM decreases symptomatic hypoglycemia by approximately 2 fold (p < 0.001) and severe hypoglycemia by 7-10 fold (p = 0.04). ADIM somewhat reduced BG variation. Mean HbA1c was comparable on ADIM (7.9 ± 0.8 %; 63 ± 9 mmol/mol) and ANIM (8.2 ± 0.7 %; 66 ± 8 mmol/mol). Using a free-mixing preparation of aspart and detemir insulin decreases hypoglycemia in young children with type 1 diabetes.

Ventricular Rate Stabilization In Patients With Permanent Atrial Fibrillation And Single-Chamber Ventricular Pacemaker: RARE-PEARL Study.

Background: In patients with permanent atrial fibrillation (AF) rate irregularity can cause symptoms and impair the pumping function of the heart. Ventricular pacing at a rate close to the mean spontaneous ventricular rate can result in a more stable ventricular rate. Specific algorithms for automatic Ventricular Rate Stabilization (VRS) were designed and implemented in commercially available pacemakers. To assess this dynamic rate control we designed the RARE-PEARL study: prospective, randomized, cross-over, double-blinded. Methods: Patients with permanent AF, symptomatic episodes of brady-tachycardia, left ventricular ejection fraction (LVEF) >40%, NYHA class I/II/III, were eligible for enrolment. Each patient (n = 67) was implanted with a single-chamber VVIR pacemaker (models C20 or T20, Vitatron BV, The Netherlands) equipped with the VRS algorithm. At the end of a four week stabilization period, patients were randomized to VRS algorithm ON or OFF (2 months) and then crossed-over for the second phase (2 months). Primary endpoint was patient's preference. Results: Sixty six patients ended the study: 19 (29%) had no preference; 15 (23%) preferred algorithm OFF, 32 (48%) algorithm ON (p<0.0001, algorithm ON vs OFF). In 58% of patients the algorithm ON caused an increase of ventricular pacing percentage > 10%. The ventricular pacing percentage was 82±10% with algorithm ON vs 59±26% with algorithm OFF (p<0.0001). Symptoms did not differ significantly. Conclusions: The VRS algorithm significantly increases the ventricular pacing percentage in patients with permanent AF. This pacing function is preferred by the majority of patients implanted with a single-chamber VVIR pacemaker.

Widespread Hypermetabolism in Symptomatic and Asymptomatic Episodes in Kleine-Levin Syndrome

BackgroundNo reliable biomarkers are identified in KLS. However, few functional neuroimaging studies suggested hypoactivity in thalamic and hypothalamic regions during symptomatic episodes. Here, we investigated relative changes in regional brain metabolism in Kleine-Levin syndrome (KLS) during symptomatic episodes and asymptomatic periods, as compared to healthy controls.MethodsFour drug-free male patients with typical KLS and 15 healthy controls were included. 18-F-fluorodeoxy glucose positron emission tomography (PET) was obtained in baseline condition in all participants, and during symptomatic episodes in KLS patients. All participants were asked to remain fully awake during the whole PET procedure.ResultsBetween state-comparisons in KLS disclosed higher metabolism in paracentral, precentral, and postcentral areas, supplementary motor area, medial frontal gyrus, thalamus and putamen during symptomatic episodes, and decreased metabolism in occipital and temporal gyri. As compared to healthy control subjects, KLS patients in the asymptomatic phase consistently exhibited significant hypermetabolism in a wide cortical network including frontal and temporal cortices, posterior cingulate and precuneus, with no detected hypometabolism. In symptomatic KLS episodes, hypermetabolism was additionally found in orbital frontal and supplementary motor areas, insula and inferior parietal areas, and right caudate nucleus, and hypometabolism in the middle occipital gyrus and inferior parietal areas.ConclusionOur results demonstrated significant hypermetabolism and few hypometabolism in specific but widespread brain regions in drug-free KLS patients at baseline and during symptomatic episodes, highlighting the behavioral state-dependent nature of changes in regional brain activity in KLS.

Prevention of low back pain: effect, cost-effectiveness, and cost-utility of maintenance care – study protocol for a randomized clinical trial

BackgroundLow back pain (LBP) is a prevalent condition and a socioeconomic problem in many countries. Due to its recurrent nature, the prevention of further episodes (secondary prevention), seems logical. Furthermore, when the condition is persistent, the minimization of symptoms and prevention of deterioration (tertiary prevention), is equally important. Research has largely focused on treatment methods for symptomatic episodes, and little is known about preventive treatment strategies.Methods/DesignThis study protocol describes a randomized controlled clinical trial in a multicenter setting investigating the effect and cost-effectiveness of preventive manual care (chiropractic maintenance care) in a population of patients with recurrent or persistent LBP.Four hundred consecutive study subjects with recurrent or persistent LBP will be recruited from chiropractic clinics in Sweden. The primary outcome is the number of days with bothersome pain over 12 months. Secondary measures are self-rated health (EQ-5D), function (the Roland Morris Disability Questionnaire), psychological profile (the Multidimensional Pain Inventory), pain intensity (the Numeric Rating Scale), and work absence.The primary utility measure of the study is quality-adjusted life years and will be calculated using the EQ-5D questionnaire. Direct medical costs as well as indirect costs will be considered.Subjects are randomly allocated into two treatment arms: 1) Symptom-guided treatment (patient controlled), receiving care when patients feel a need. 2) Preventive treatment (clinician controlled), receiving care on a regular basis. Eligibility screening takes place in two phases: first, when assessing the primary inclusion/exclusion criteria, and then to only include fast responders, i.e., subjects who respond well to initial treatment. Data are collected at baseline and at follow-up as well as weekly, using SMS text messages.DiscussionThis study investigates a manual strategy (chiropractic maintenance care) for recurrent and persistent LBP and aims to answer questions regarding the effect and cost-effectiveness of this preventive approach. Strict inclusion criteria should ensure a suitable target group and the use of frequent data collection should provide an accurate outcome measurement. The study utilizes normal clinical procedures, which should aid the transferability of the results.Trial registrationClinical trials.gov; NCT01539863, February 22, 2012. The first patient was randomized into the study on April 13th 2012.