Outcome of tonsillotomy in children with obstructive sleep-disordered breathing.

OBJECTIVE/BACKGROUND: Most children treated for obstructive sleep disordered breathing (oSDB) are not systematically assessed by polysomnography (PSG) nor by structuredsymptom quantification before surgical treatment. The main objective of this study wasto investigate the effect of adeno-tonsillotomy (ATO) on symptom burden and PSGparameters. METHODS: Children aged 2-10 years with oSDB were selected for ATO based uponclinical findings according to current standards of care in Denmark. Each childunderwent standardized assessment before and 3 months after surgery, including aPSG, tonsil size assessment, and the Pediatric Sleep Questionnaire -Sleep RelatedBreathing Disorder (PSQ) to quantify symptom burden. Obstructive sleep apnea (OSA)was defined as an obstructive apnea-hypopnea index (oAHI) ≥2/h. Successfultreatment was defined as post-surgery oAHI ≤5/h, and complete cure as oAHI ≤2/h. RESULTS: Fifty-two children were included. Mean age was 5.0 years (SD ± 1.76). Thirteen children were identified with baseline oAHI <2/h. Significant improvement inOSA severity was observed in children with moderate-to-severe OSA, in whom oAHI decreased from 15.7/h to 2.6/h (p < 0.001). Treatment success was obtained in 85% and cure was obtained in 42% of children. PSQ-score significantly improved from 0.52 (CI 0.47-0.56) to 0.26 (CI 0.21-0.32) (p < 0.001). Baseline OSA severity was notcorrelated to baseline symptom burden nor to symptom relief after ATO. There were noserious adverse events. CONCLUSIONS: Adeno-tonsillotomy significantly reduced symptom burden in otherwise healthy children with oSDB symptoms. Significant improvement in oAHI was observedonly in children with moderate-to-severe OSA. We recommend combining clinicalevaluation with PSQ and oAHI.

Cold steel versus impedance-dependent tissue sealer tonsillectomy - a study protocol for a randomised controlled trial.

INTRODUCTION: Approximately 7,000 tonsillectomies are performed annually in Denmark on a benign basis. The cold steel surgical technique is the gold standard. The risk of post tonsillectomy bleeding (PTH) in a centre in Jutland is 7.9%. A new impedance-dependent tissue sealer (IDTS) device has been developed, with preliminary results showing a reduction in operation time, perioperative bleeding and post-operative risk of bleeding of 4.5%. METHODS: A randomised, controlled, double-blinded multicentre trial of cold steel tonsillectomy versus IDTS will be performed on 1,250 patients. The main endpoint is PTH, perioperative bleeding, operation time and post-operative pain. The secondary outcomes are days until return to work, food intake, activity and quality of life. Included in the study are patients with indication for surgery weighing ≥ 16 kg, and excluded are patients with malignancy, bleeding disorders and unwillingness to participate in the study. CONCLUSIONS: To our knowledge, the present study is the largest randomised controlled trial in ENT surgery in the Nordic countries. The study will potentially provide evidence on PTH regarding two tonsillectomy methods. FUNDING: The authors have no potential conflicts of interest to declare. The study is supplied with instruments from Medtronic needed for the surgical procedures. Furthermore, a minor part of the funding of the entire project is provided by the aforementioned company. The funding providers have no role in design or conduct of the study. CLINICALTRIALS: gov with the identification number NCT05270109.

Does DISE increase the success rate of surgery for obstructive sleep apnea in children? A systematic review of DISE directed treatment of children with OSAS.

OBJECTIVE: A systematic review of the evidence on the success of Drug-Induced Sleep Endoscopy (DISE) directed surgery in children with obstructive sleep apnea (OSA) defined as cure rate. DATA SOURCES: The PRISMA guidelines were followed and three databases (PubMed, Embase and Cochrane Library) were searched for studies on DISE directed surgery in children. ENDPOINTS: Pre- and post-surgical change in polysomnography (PSG); change in surgical target; side effects. REVIEW METHODS: Study quality was assessed using the modified Delphi technique quality appraisal tool for case series. Risk of bias was assessed using the Cochrane Collaboration's tool for assessing risk of bias. RESULTS: A total of 1805 studies were found. The most important reasons for exclusion were as follows: none-DISE studies, reports on adults, conflation of results on syndromic and healthy patients, no relevant outcome measurements. Five studies with a total of 376 patients (range: 26-126) were included. The surgeons changed the planned strategy in 50.4 % of patients according to the DISE findings. Comparison of pre- and post-surgical sleep monitoring revealed an average decrease in apnea-hypopnea index (AHI) of 11.1 and a treatment success (AHI < 5) and cure (AHI < 2) of 78 % and 53 %, respectively. The quality of the included studies was moderate especially due to small populations, designs without randomization or control groups, lack of analysis of drop outs, short follow-up, and considerable level of bias. CONCLUSION: DISE directed surgery has been shown to change the surgical approach when treating children with OSA. If this can be transferred into a better outcome compared to standard surgical treatment is unknown, due to the current poor level of evidence. To decide whether or not DISE should be included in the treatment of children with OSA, we suggest further data, preferably an RCT, to increase the level of evidence.

Comparison of clinical practice of tonsil surgery from quality register data from Sweden and Norway and one clinic in Denmark.

OBJECTIVES: To compare the application of indications, demographics, surgical and haemostatic techniques in tonsil surgery in three countries. DESIGN: Non-randomised, prospective, observational cohort. SETTING: All patients registered in the National Tonsil Surgery Quality Registers in Sweden, Norway and West Jutland, Denmark. PARTICIPANTS: Data were retrieved from 2017 to 2019; registered surgeries: Sweden: 20 833; Norway: 10 294 and West Jutland, Denmark: 505. RESULTS: Tonsil surgery for obstruction was twice as common in Sweden (62.2%) compared with Norway (31%) and Denmark (27.7%). Recurrent tonsillitis was registered twice as frequently in Norway (35.7%) and Denmark (39%) compared with Sweden (16.7%). Chronic tonsillitis was registered more frequently in Norway (29.8%) than in Sweden (13.8%) and Denmark (12.7%). Day surgery (>76%) was comparable. The higher frequency of obstruction in Sweden affected age and gender distributions: Sweden (7 years, 50.4% boys), Norway (17 y, 42.1%) and Denmark (19 y, 38.4%). For obstructive disorders, tonsillotomy with adenoidectomy was used in a majority of Swedish children (72%), whereas tonsillectomy with or without adenoidectomy dominated in Norway (53.5%) and Denmark (57.9%). Cold steel was the technique of choice for tonsillectomy in all three countries. For tonsillotomy, hot dissection techniques dominated in all countries. Disparities were observed with regard to haemostatic techniques. Bipolar diathermy was commonly used in all countries. Monopolar diathermy was practically only used in Sweden. Infiltration with epinephrine in the tonsillar bed was registered in Sweden and Norway but not at all in Denmark. Combined cold surgical and cold haemostatic techniques were more commonly used in Sweden (22.7%) than in Norway (10.4%) and Denmark (6.2%). CONCLUSIONS: This study demonstrates disparities among the Nordic countries in tonsil surgery in terms of indications plus surgical and haemostatic techniques. Increased coverage and further monitoring of outcomes is needed to identify best practices and ideal guidelines for improved care.

Ambulatory blood pressure using 60 rather than 20-min intervals may better reflect the resting blood pressure.

PURPOSE: Twenty-four hours of ambulatory blood pressure monitoring (ABPM) is recommended in several guidelines as the best method for diagnosing hypertension. In general, the prognostic value of ABPM is superior to single office blood pressure (BP) measurements. Unfortunately, some patients experience considerable discomfort during frequently repeated forceful cuff inflations. MATERIALS AND METHODS: In this study we investigated the difference in mean daytime systolic BP (SBP) between low-frequency ABPM (LF-ABPM), measuring once every hour, and high-frequency ABPM (HF-ABPM), measuring three times an hour during daytime, and two times an hour during night-time. RESULTS: Seventy-one patients were included in the analysis. All included patients had an HF-ABPM performed first and within a few weeks they underwent an LF-ABPM. The average day time difference in SBP between the two frequencies was 3.8 mmHg (p-value = 0.07) for mild, 8.2 mmHg (p-value < 0.01) for moderate and 15 mmHg (p-value < 0.001) for severe hypertension. A similar pattern was seen for night-time SBP. This study suggests that mean BP is similar between the two measuring frequencies for normotensive and mild hypertensive patients, while HF-ABPM results in a higher 24-h mean BP for moderate- and severe hypertensive patients. CONCLUSION: LF-ABPM may more correctly reflect the resting blood pressure in patients with moderate and severe hypertension.

Feasibility of conducting type III home sleep apnoea test in children.

OBJECTIVES: To test the feasibility of conducting unattended paediatric type III HSAT and to identify issues for improvements to optimize signal quality. MATERIAL AND METHODS: Parents were instructed in setting up the unattended HSAT and reported their experiences. Signal quality and causes of signal failure of recordings were assessed. RESULTS: Forty children were included. Mean age was 5.2 years. Predefined success criteria were met in 53% of recordings. Main causes of signal failure were nasal cannula, pulse-oximetry and battery failure. Sensor fixation techniques were developed and implemented during the study and hence signal quality improved. Seventeen (94%) parents reported HSAT to be either easy or medium hard to use.Conclusions and significance: Unattended paediatric type III HSAT can be conducted at home with acceptable signal quality. Signal quality improved considerably using simple sensor fixation techniques.

The first experiences of implementation of the Swedish tonsil register in Denmark.

Background: Tonsil surgery is a daily procedure at Ear, Nose and Throat (ENT) departments as well as ENT practices. Despite national tonsil guidelines in Denmark, no national survey has been introduced.Objectives: To display the process of implementing a Danish version of the Swedish tonsil register including a presentation and validation of the first year's results.Methods: The Swedish tonsil register was translated into Danish. Minor modifications were executed and the register was implemented at the ENT department, Region Hospital West Jutland, Denmark. All patients undergoing surgery due to benign tonsil and/or adenoid diseases were eligible. Written informed consent was obtained. Indication for surgery, comorbidity, surgical and haemostasis techniques, and complications were registered by the surgeon.Results: Several obstacles were encountered due to legal procedures, daily work, IT organisation, and discontinuous information. 58% of eligible patients were registered. The incidence of post-tonsillectomy haemorrhage requiring secondary surgery was 6.4%. The potential underlying risk factors were easily retrieved from the register.Conclusions and significance: The Danish version of the national Swedish tonsil database is a useful, easily accessible, and informative tool for monitoring and validation of tonsil/adenoid surgery. We recommend a nationwide register with a central steering committee.

Shared care versus hospital-based cardiac rehabilitation: a cost-utility analysis based on a randomised controlled trial.

Background: Changes in the organisation of chronic healthcare, an increased awareness of costs and challenges of low adherence in cardiac rehabilitation (CR) call for the exploration of more flexible CR programmes as alternatives to hospital-based CR (H-CR). A model of shared care cardiac rehabilitation (SC-CR) that included general practitioners and the municipality was developed. The aim of this study was to analyse the cost utility of SC-CR versus H-CR. Methods: The cost-utility analysis was based on a randomised controlled trial of 212 patients who were allocated to SC-CR or H-CR and followed up for 12 months. A societal cost perspective was applied that included the cost of intervention, informal time, healthcare and productivity loss. Costing was based on a microcosting approach for the intervention and on national administrative registries for the other cost categories. Quality-adjusted life years (QALYs) were based on the EuroQol 5-Dimensions measurements at baseline, after 4 months and after 12 months. Conventional cost-effectiveness methodology was employed to estimate the net benefit of SC-CR. Results: The average cost of SC-CR was 165.5 kDKK and H-CR 163 kDKK. Productivity loss comprised 74.1kDKK and 65.9 kDKK. SC-CR cost was an additional 2.5 kDKK (95% CI -38.1 to 43.1) ≈ (0.33; -5.1 to 5.8 k€) and a QALY gain of 0.02 (95% CI -0.03 to 0.06). The probability that SC-CR would be cost-effective was 59% for a threshold value of willingness to pay of 300 kDKK (k€40.3). Conclusion: CR after shared care model and H-CR are comparable and similar in socioeconomic terms. Trial registration number: NCT01522001; Results.

Effects of renal denervation on coronary flow reserve and forearm dilation capacity in patients with treatment-resistant hypertension. A randomized, double-blinded, sham-controlled clinical trial.

BACKGROUND: Microvascular impairment is well documented in hypertension. We investigated the effect of renal sympathetic denervation (RDN) on cardiac and peripheral microvasculature in patients with treatment-resistant essential hypertension (TRH). METHODS: A randomized, single centre, double-blinded, sham-controlled clinical trial. Fifty-eight patients with TRH (ambulatory systolic BP (ASBP) ≥ 145mmHg) despite stable treatment were randomized to RDN or SHAM. RDN was performed with the unipolar Medtronic Flex catheter. Coronary flow reserve (CFR) and coronary- and forearm minimum vascular resistance (C-Rmin and F-Rmin) were determined using transthoracic Doppler echocardiography and F-Rmin with venous occlusion plethysmography at baseline and at six-months follow-up. RESULTS: RDN was performed with 5.3±0.2 lesions in the right renal artery and 5.4±0.2 lesions in the left. Baseline ASBP was 152±2mmHg (RDN, n=29) and 154±2mmHg (SHAM, n=29). Similar reductions in MAP were seen at follow up (-3.5±2.0 vs. -3.2±1.8, P=0.92). Baseline CFR was 2.9±0.1 (RDN) and 2.4±0.1 (SHAM), with no significant change at follow-up (0.2±0.2 vs. -0.1±0.2, P=0.57). C-Rmin was 1.9±0.3 (RDN) and 2.7±0.6 (SHAM) (mmHgmin/ml pr. 100g) and did not change significantly (0.3±0.5 vs. -0.4±0.8, P=0.48). F-Rmin was 3.6±0.2 (RDN) and 3.6±0.3 (SHAM) (mmHgmin/ml pr. 100ml tissue) and unchanged at follow-up (4.2±0.4 vs. 3.8±0.2, P=0.17). Left ventricular mass index was unchanged following RDN (-4±7 (RDN) vs. 3±5 (SHAM) (g/m2) P=0.38). CONCLUSION: The current study does not support positive effects of RDN on microvascular impairment in TRH.

The effect of renal denervation on arterial stiffness, central blood pressure and heart rate variability in treatment resistant essential hypertension: a substudy of a randomized sham-controlled double-blinded trial (the ReSET trial).

OBJECTIVES: To investigate, whether renal denervation (RDN) improves arterial stiffness, central blood pressure (C-BP) and heart rate variability (HRV) in patients with treatment resistant hypertension. METHODS: ReSET was a randomized, sham-controlled, double-blinded trial (NCT01459900). RDN was performed by a single experienced operator using the Medtronic unipolar Symplicity FlexTM catheter. C-BP, carotid-femoral pulse wave velocity (PWV), and HRV were obtained at baseline and after six months with the SphygmoCor®-device. RESULTS: Fifty-three patients (77% of the ReSET-cohort) were included in this substudy. The groups were similar at baseline (SHAM/RDN): n = 27/n = 26; 78/65% males; age 59 ± 9/54 ± 8 years (mean ± SD); systolic brachial BP 158 ± 18/154 ± 17 mmHg; systolic 24-hour ambulatory BP 153 ± 14/151 ± 13 mmHg. Changes in PWV (0.1 ± 1.9 (SHAM) vs. -0.6 ± 1.3 (RDN) m/s), systolic C-BP (-2 ± 17 (SHAM) vs. -8 ± 16 (RDN) mmHg), diastolic C-BP (-2 ± 9 (SHAM) vs. -5 ± 9 (RDN) mmHg), and augmentation index (0.7 ± 7.0 (SHAM) vs. 1.0 ± 7.4 (RDN) %) were not significantly different after six months. Changes in HRV-parameters were also not significantly different. Baseline HRV or PWV did not predict BP-response after RDN. CONCLUSIONS: In a sham-controlled setting, there were no significant effects of RDN on arterial stiffness, C-BP and HRV. Thus, the idea of BP-independent effects of RDN on large arteries and cardiac autonomic activity is not supported.

Cardiac rehabilitation after acute coronary syndrome comparing adherence and risk factor modification in a community-based shared care model versus hospital-based care in a randomised controlled trial with 12 months of follow-up.

AIM: To investigate whether phase II cardiac rehabilitation (CR) conducted by a community model of shared care CR (SC-CR) including health care centres and general practice was feasible and provided acceptable results and to compare SC-CR to hospital-based CR (H-CR) in a randomised controlled trial. METHODS: Patients were randomised to H-CR or SC-CR after admission for acute coronary syndrome. In SC-CR, the general practitioner took over the responsibility of the remaining rehabilitation, pharmacological treatment and risk factor management after the initial visit to the hospital outpatient clinic. The Municipal Health Care Centres provided courses on smoking cessation, nutrition, and exercise training and contributed to disease education and psychosocial support. The main endpoint was adherence to the CR programme and compliance with lifestyle modifications. RESULTS: In total, 1364 patients were screened, 327 (24%) were eligible, and 212 (65%) accepted participation. Phase II CR was completed by 192 (91%) of the participants. Full adherence to the CR programme was seen in 53% in SC-CR versus 54% in H-CR (relative risk (RR): 0.98, 95% confidence interval: 0.73-1.32). In H-CR, patients had higher rates of adherence to dietary advice and health education. In SC-CR, 12% of patients did not attend the risk factor evaluation and clinical assessment with their general practitioner. No difference in risk factor improvement was found. Exercise training was declined by 25% in both groups. CONCLUSION: Adherence to phase II CR was high in both groups. SC-CR did not improve adherence and efficacy, but had comparable effects on medication and risk factors. Thus, SC-CR was safe and effective.

Renal denervation in treatment-resistant essential hypertension. A randomized, SHAM-controlled, double-blinded 24-h blood pressure-based trial.

BACKGROUND: Renal denervation (RDN), treating resistant hypertension, has, in open trial design, been shown to lower blood pressure (BP) dramatically, but this was primarily with respect to office BP. METHOD: We conducted a SHAM-controlled, double-blind, randomized, single-center trial to establish efficacy data based on 24-h ambulatory BP measurements (ABPM). Inclusion criteria were daytime systolic ABPM at least 145 mmHg following 1 month of stable medication and 2 weeks of compliance registration. All RDN procedures were carried out by an experienced operator using the unipolar Medtronic Flex catheter (Medtronic, Santa Rosa, California, USA). RESULTS: We randomized 69 patients with treatment-resistant hypertension to RDN (n = 36) or SHAM (n = 33). Groups were well balanced at baseline. Mean baseline daytime systolic ABPM was 159 ±â€Š12 mmHg (RDN) and 159 ±â€Š14 mmHg (SHAM). Groups had similar reductions in daytime systolic ABPM compared with baseline at 3 months [-6.2 ±â€Š18.8 mmHg (RDN) vs. -6.0 ±â€Š13.5 mmHg (SHAM)] and at 6 months [-6.1 ±â€Š18.9 mmHg (RDN) vs. -4.3 ±â€Š15.1 mmHg (SHAM)]. Mean usage of antihypertensive medication (daily defined doses) at 3 months was equal [6.8 ±â€Š2.7 (RDN) vs. 7.0 ±â€Š2.5 (SHAM)].RDN performed at a single center and by a high-volume operator reduced ABPM to the same level as SHAM treatment and thus confirms the result of the HTN3 trial. CONCLUSION: Further, clinical use of RDN for treatment of resistant hypertension should await positive results from double-blinded, SHAM-controlled trials with multipolar ablation catheters or novel denervation techniques.

Hospital-based versus community-based shared care cardiac rehabilitation after acute coronary syndrome: protocol for a randomized clinical trial.

INTRODUCTION: Participation in cardiac rehabilitation (CR) is poor although CR reduces morbidity and mortality. One way in which attendance may potentially be improved is by involving municipal health-care centres (MHCC) and the patient's general practitioner (GP) to a larger degree in a model of shared care cardiac rehabilitation (SC-CR). Our study tests the feasibility of SC-CR and compares the attendance and effects of SC-CR with the individually tailored hospital-based CR (H-CR) programme. MATERIAL AND METHODS: After admission for acute coronary syndrome (ACS) patients are randomized to phase II CR which is conducted either as SC-CR or H-CR. During SC-CR the patient is seen once in-hospital after which the GP takes over. MHCC supports the GP by offering educational intervention regarding smoking cessation, exercise, nutrition and mental health. A total of 208 persons hospitalised due to acute coronary syndrome are to be randomized before hospital discharge. CONCLUSION: The study aims to examine whether the organisation of SC-CR is feasible and provides the expected benefits. FUNDING: The trial is funded by Region Central Denmark. TRIAL REGISTRATION: Clinical Trials ID: NTC 01522001.

[Deep venous thrombosis caused by severe infection with group A streptococci]. / Dyb venøs trombose udløst af alvorlig infektion med haemolytiske streptokokker gruppe A.

A 38-year-old diabetic woman presented with a deep venous thrombosis of the right calf muscle two weeks after an infection of the pharynx. After one week of treatment with warfarin, she was readmitted in septic shock with a massive swelling of the leg. The thrombosis had progressed to the right iliac and femoral veins, and an abscess of the iliopsoas muscle caused by group A streptococci was detected. The treatment consisted of surgical drainage, intravenous penicillin and eventually hip joint exarticulation.