Effects of Adaptive Servo-Ventilation on Quality of Life: The READ-ASV Registry.

Rationale: Adaptive servo-ventilation (ASV) effectively treats sleep-disordered breathing, including central sleep apnea (CSA) and coexisting obstructive sleep apnea (OSA).Objectives: The prospective, multicenter European READ-ASV (Registry on the Treatment of Central and Complex Sleep-Disordered Breathing with Adaptive Servo-Ventilation) registry investigated the effects of first-time ASV therapy on disease-specific quality of life (QoL).Methods: The registry enrolled adults with CSA with or without OSA who had ASV therapy prescribed between September 2017 and March 2021. The primary endpoint was change in disease-specific QoL (Functional Outcomes of Sleep Questionnaire [FOSQ]) score between baseline and 12-month follow-up. Sleepiness determined using the Epworth Sleepiness Scale (ESS) score was a key secondary outcome. For subgroup analysis, participants were classified as symptomatic (FOSQ score < 17.9 and/or ESS score > 10) or asymptomatic (FOSQ score ⩾ 17.9 and/or ESS score ⩽ 10).Results: A total of 801 individuals (age, 67 ± 12 yr; 14% female; body mass index, 31 ± 5 kg/m2; apnea-hypopnea index, 48 ± 22/h) were enrolled; analyses include those with paired baseline and follow-up data. After 12 ± 3 months on ASV, median (interquartile range) FOSQ score had increased significantly from baseline (+0.8 [-0.2 to 2.2]; P < 0.001; n = 499). This was due to a significantly increased FOSQ score in symptomatic participants (+1.69 [0.38 to 3.05]), with little change in asymptomatic individuals (+0.11 [-0.39 to 0.54]). The median ESS score also improved significantly from baseline during ASV (-2.0 [-5.0 to 0.0]; P < 0.001).Conclusions: ASV treatment of CSA with or without coexisting OSA was associated with improvements in disease-specific QoL and daytime sleepiness, especially in individuals with sleep-disordered breathing symptoms before therapy initiation. These improvements in patient-reported outcomes support the use of ASV in this population.

Registry on the Treatment of Central and Complex Sleep-Disordered Breathing with Adaptive Servo-Ventilation (READ-ASV): protocol and cohort profile.

Background: Although adaptive servo-ventilation (ASV) effectively supresses central sleep apnoea (CSA), little is known about real-world indications of ASV therapy and its effects on quality of life (QoL). Methods: This report details the design, baseline characteristics, indications for ASV and symptom burden in patients enrolled in the Registry on the Treatment of Central and Complex Sleep-Disordered Breathing with Adaptive Servo-Ventilation (READ-ASV). This multicentre, European, non-interventional trial enrolled participants prescribed ASV in clinical practice between September 2017 and March 2021. An expert review board assigned participants to ASV indications using a guideline-based semi-automated algorithm. The primary end-point was change in disease-specific QoL based on the Functional Outcomes of Sleep Questionnaire (FOSQ) from baseline to 12-month follow-up. Results: The registry population includes 801 participants (age 67±12 years, 14% female). Indications for ASV were treatment-emergent or persistent CSA (56%), CSA in cardiovascular disease (31%), unclassified CSA (2%), coexisting obstructive sleep apnoea and CSA (4%), obstructive sleep apnoea (3%), CSA in stroke (2%) and opioid-induced CSA (1%). Baseline mean apnoea--hypopnoea index was 48±23 events·h-1 (≥30 events·h-1 in 78%), FOSQ score was 16.7±3.0 (<17.9 in 54%) and Epworth Sleepiness Scale (ESS) score was 8.8±4.9 (>10 in 34%); 62% of patients were symptomatic (FOSQ score <17.9 or ESS score >10). Conclusion: The most common indications for ASV were treatment-emergent or persistent CSA or CSA in cardiovascular disease (excluding systolic heart failure). Patients using ASV in clinical practice had severe sleep-disordered breathing and were often symptomatic. One-year follow-up will provide data on the effects of ASV on QoL, respiratory parameters and clinical outcomes in these patients.

Navigation of lead extraction-is it possible? Impact of preprocedural electrocardiogram-triggered computed tomography on navigation of lead extraction.

OBJECTIVES: As the number of transvenous lead extractions continues to increase, preprocedural protocols for this procedure must be assessed. The objective of this study was to determine whether an electrocardiogram (ECG)-triggered computed tomography (Et-CT) with three-dimensional (3D) reconstructions could aid lead extractors in choosing the optimal tools to improve procedural success and avoid complications. METHODS: In this study, 31 patients scheduled for transvenous lead extraction underwent a preprocedural Et-CT between January 2016 and May 2017. Both 3D-reconstructions and the two-dimensional files were reviewed for possible lead adhesions, calcifications, migrations or perforations. RESULTS: Mean age was 46.7 ± 14.0 years. Seventy-one percent of patients were men, and 29.0% had undergone prior cardiac surgery. Indications for extraction included infection (n = 18, 58.1%), lead dysfunction (n = 8, 25.8%), upgrade (n = 3, 9.7%), severe tricuspid regurgitation (n = 1, 3.2%) and superior vena cava occlusion (n = 1, 3.2%). Eighteen patients had an implantable cardioverter defibrillator (58.1%). Sixty-eight of 70 targeted leads were extracted with a mean of 2.2 leads per patient and an average lead age of 109.3 ± 58.7 months. Et-CT files supported transvenous lead extraction by revealing possible adhesions in 16 patients, 5 perforations and 2 venous occlusions. Lead extraction was performed using the excimer laser, mechanical tools and femoral snares. Complete procedural success was achieved in 93.5% (n = 29) of cases. Clinical success was 100%, and intraoperative mortality was 0%. CONCLUSIONS: A preprocedural Et-CT with 3D reconstructions can help to visualize lead alignment and identify abnormalities that may foreshadow procedural difficulties. A preprocedural Et-CT may therefore aid lead extractors in choosing the optimal extraction tool and strategy.

Effectiveness of 2 Osteopathic Treatment Approaches on Pain, Pressure-Pain Threshold, and Disease Severity in Patients with Fibromyalgia: A Randomized Controlled Trial.

OBJECTIVE: To assess the effectiveness of osteopathic intervention (OI) and general osteopathic treatment (GOT) in individuals with fibromyalgia syndrome (FMS). METHODS: The trial was designed as a randomized controlled trial with 2 osteopathic interventions and 1 untreated control group. The patients in the two osteopathic groups received 10 osteopathic treatments (OI or GOT) within a time period of 12 weeks. The control group did not receive any osteopathic treatment. The primary outcome was the average pain intensity (API) assessed by visual analog scale (VAS). Secondary outcomes were the pressure-pain threshold rated by means of a tender point score, and disease severity, assessed by the Fibromyalgia Impact Questionnaire (FIQ). RESULTS: 50 patients were randomized. The primary outcome parameter API decreased from 7.2 to 4.7 in the OI group, from 6.3 to 4.3 in the GOT group, and increased slightly in the control group from 6.2 to 6.6. There were significant differences for the change in API between the OI group and the control group (VAS: 2.9, 95% confidence interval (CI) = 1.12-4.52), and between the GOT group and the control group (VAS: 2.4, 95% CI = 0.65-4.11), but no significant differences between the OI group and the GOT group. There were no significant differences for the secondary outcome parameters between the groups. CONCLUSION: A series of osteopathic treatments might be beneficial for patients suffering from FMS.

Ingestion of an Oral Hyaluronan Solution Improves Skin Hydration, Wrinkle Reduction, Elasticity, and Skin Roughness: Results of a Clinical Study.

Intake of oral supplements with the aim of a cutaneous antiaging effect are increasingly common. Hyaluronic acid (HA) is a promising candidate, as it is the key factor for preserving tissue hydration. In our practice study, we evaluated the effect of an oral HA preparation diluted in a cascade-fermented organic whole food concentrate supplemented with biotin, vitamin C, copper, and zinc (Regulatpro Hyaluron) on skin moisture content, elasticity, skin roughness, and wrinkle depths. Twenty female subjects with healthy skin in the age group of 45 to 60 years took the product once daily for 40 days. Different skin parameters were objectively assessed before the first intake, after 20 and after 40 days. Intake of the HA solution led to a significant increase in skin elasticity, skin hydration, and to a significant decrease in skin roughness and wrinkle depths. The supplement was well tolerated; no side effects were noted throughout the study.

Prolonged Temozolomide Maintenance Therapy in Newly Diagnosed Glioblastoma.

BACKGROUND: The impact of prolonging temozolomide (TMZ) maintenance beyond six cycles in newly diagnosed glioblastoma (GBM) remains a topic of discussion. We investigated the effects of prolonged TMZ maintenance on progression-free survival (PFS) and overall survival (OS). PATIENTS AND METHODS: In this retrospective single-center cohort study, we included patients with GBM who were treated with radiation therapy with concomitant and adjuvant TMZ. For analysis, patients were considered who either completed six TMZ maintenance cycles (group B), continued with TMZ therapy beyond six cycles (group C), or stopped TMZ maintenance therapy within the first six cycles (group A). Patients with progression during the first six TMZ maintenance cycles were excluded. RESULTS: Clinical data from 107 patients were included for Kaplan-Meier analyses and 102 for Cox regressions. Median PFS times were 8.1 months (95% confidence interval [CI] 6.1-12.4) in group A, 13.7 months (95% CI 10.6-17.5) in group B, and 20.9 months (95% CI 15.2-43.5) in group C. At first progression, response rates of TMZ/lomustine rechallenge were 47% in group B and 13% in group C. Median OS times were 12.7 months (95% CI 10.3-16.8) in group A, 25.2 months (95% CI 17.7-55.5) in group B, and 28.6 months (95% CI 24.4-open) in group C. Nevertheless, multivariate Cox regression for patients in group C compared with group B that accounted for imbalances of other risk factors showed no different relative risk (RR) for OS (RR 0.77, p = .46). CONCLUSION: Our data do not support a general extension of TMZ maintenance therapy beyond six cycles. The Oncologist 2017;22:570-575 IMPLICATIONS FOR PRACTICE: Radiation therapy with concomitant and adjuvant temozolomide (TMZ) maintenance therapy is still the standard of care in patients below the age of 65 years in newly diagnosed glioblastoma. However, in clinical practice, many centers continue TMZ maintenance therapy beyond six cycles. The impact of this continuation is controversial and has not yet been addressed in prospective randomized clinical trials. We compared the effect of more than six cycles of TMZ in comparison with exactly six cycles on overall survival (OS) and progression-free survival (PFS) by multivariate analysis and found a benefit in PFS but not OS. Thus, our data do not suggest prolonging TMZ maintenance therapy beyond six cycles, which should be considered in neurooncological practice.

In vivo study for tooth colour determination-visual versus digital.

OBJECTIVES: Tooth colour determination is an essential component in the preservative and prosthetic workflow during production of tooth-coloured restorations. The aim of the study was to compare the clinical suitability of conventional, visual tooth colour determination and digital methods. MATERIALS AND METHODS: Tooth colour of vital, natural central incisors among a total of 107 subjects was determined visually by a dentist (VD) and dental technician (VDT) using VITA Toothguide 3D-MASTER®, digitally by the spectrophotometer VITA Easyshade Advance 4.0 (reference instrument) and Trios®Color intra-oral scanner (test subject). Reliability was examined by repeating the digital measurements of 20 teeth three times. The analysis was based on the recorded 3D-MASTER values and L*a*b/L*C*h parameters. RESULTS: The measuring accuracy was 43.9% with the Trios®Color scanner, 35.5% for VD and 34.6% for VDT. In 25.5% of cases, the scanner's results corresponded with VD and in 33.6% with VDT. The visual methods corresponded with 45.8%. All mean values of the recorded colour differences fell within the clinically acceptable range of ΔE ≤ 6.8. The intra-oral scanner attained repeatability of 78.3% and the VITA Easyshade system of 76.6%. CONCLUSIONS: The Trios®Color intra-oral scanner appears to be a good alternative to the current standard of visual tooth colour determination. The new module attains better results than the visual method and is comparable to the reference instrument. CLINICAL RELEVANCE: Dentistry becomes increasingly digitalized and tooth colour determination devices have generally to be improved. Therefore, the investigation of a new digital device is important for future developments.

2D Versus 3D in Laparoscopic Surgery by Beginners and Experts: A Randomized Controlled Trial on a Pelvitrainer in Objectively Graded Surgical Steps.

BACKGROUND AND OBJECTIVE: Progress in endoscopic surgery in the past few decades has led to the application of 3-dimensional (3D) procedures in operating rooms. This permits patient- and surgeon-friendly operations and also maximizes the superiority of laparoscopy over laparotomy. In this study, we compare 2-dimensional (2D) and 3D endoscopy techniques with regard to time, efficiency, optics, and handling by users with different degrees of experience at 4 difficulty levels. DESIGN: A randomized controlled trial on a pelvitrainer in objectively graded surgical steps for students and postgraduates. SETTING: The trials took place at the Kiel School of Gynaecological Endoscopy, a training unit of the Kiel University Department of Obstetrics and Gynecology, a tertiary academic medical center. PARTICIPANTS: The 277 study participants, divided into students, residents, and specialists, worked on pelvitrainers with 2 different optical systems, the 2D full HD and the 3D mode. The following 4 exercises were performed with each optical system: (1) grasping and transferring of pins, (2) cutting predetermined marks, (3) vaginal closure with prevention of prolapse, and (4) sacrocolpopexy. The duration and success of the tasks were measured and compared. A self-assessment questionnaire was completed by the participants. RESULTS: Overall, the 3D-system permitted a greater improvement in working speed, superior optical visualization, and better endoscopic handling in all groups, independent of surgical experience. All students improved in speed (exercises: 1-3) and made significantly fewer mistakes (exercise 2) on 3D compared with 2D. Residents made progress in time (exercises: 1-4) and task performance (exercise 3). Specialists improved significantly in the more challenging tasks 3 and 4. Subjectively, 68.8% of participants preferred 3D for performing laparoscopy. CONCLUSION: Systematic training programs on pelvitrainers can improve endoscopic skills not only in beginners but also in experienced surgeons. The 3D system offered distinct advantages over 2D imaging and was well accepted by surgeons.

Magnetic field therapy in patients with cytostatics-induced polyneuropathy: A prospective randomized placebo-controlled phase-III study.

No causal treatment for chemotherapy-induced peripheral neuropathy (CIPN) is known. Therefore, there is an urgent need to develop a therapy for CIPN. Only scarce clinical data are available concerning magnetic field therapy (MFT) in this context. We conducted a unicentric, randomized, double-blind, placebo-controlled phase-III trial of an MFT device versus placebo. In this study, we randomized 44 patients with CIPN to two treatment groups, where 21 patients were treated with MFT (Group 1) and 23 patients received placebo (Group 2). We evaluated the efficacy of MFT at baseline (T1 ), after 3 weeks of study treatment (T2 ), and after 3 months of study treatment (T3 ). The primary endpoint was nerve conduction velocity (NCV), while secondary endpoints were the Common Toxicity Criteria (CTCAE) score and the Pain Detect End Score at T3 . Seventeen of the patients in Group 1 and 14 patients in Group 2 completed the respective study treatment. The primary endpoint, significant improvement of NCV at T3 , was achieved by MFT (P = 0.015), particularly for sensory neurotoxicity of the peroneal nerve. Also, in respect to the secondary endpoints, significant improvement (P = 0.04) was achieved in terms of the patients' subjectively perceived neurotoxicity (CTCAE score), but not of neuropathic pain (P = 0.11). From data in the randomized study presented here, a positive effect on the reduction of neurotoxicity can be assumed for the MFT device. Patients with sensory neurotoxicity in the lower limbs, especially, should therefore be offered this therapy. Bioelectromagnetics. 38:85-94, 2017. © 2016 The Authors. Bioelectromagnetics published by Wiley Periodicals, Inc.

Effects of PEMF on patients with osteoarthritis: Results of a prospective, placebo-controlled, double-blind study.

This study aimed to evaluate effects of pulsed electromagnetic fields (PEMF) in a double blind study on patients with knee joint osteoarthritis. The MAGCELL ARTHRO electrode-less therapy delivered a sinusoidal magnetic field, varying in frequency between 4 and 12 Hz. In 1 cm tissue depth, magnetic flux density was 105 mT. A total of n = 57 patients were randomly assigned to the verum, PEMF or placebo group (placebo device). Their average age was 61.6 ± 12.0 years. According to American College of Rheumatology criteria the osteoarthritis level was 2.8 ± 0.8. Treatment was performed twice a day for 5 min over a period of 18 days. Treatment with the MAGCELL device versus control (sham exposed) showed a highly significant reduction in pain (P < 0.001), a significant reduction in stiffness (P = 0.032) and a significant reduction in disability in daily activities (P = 0.005) according to the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) scales-with a good overall treatment tolerance. In the placebo group there was no evidence of a significant change between the initial and final examination in any of the three above-mentioned WOMAC scales. Results of this partly randomized placebo-controlled double-blind study show clinically at any rate, that use of PEMF lead to highly significant better results in the treatment group compared to the placebo group with regard to the total WOMAC global score and especially for visual analogue scale. Patient assessment of the "effectiveness" was rated in 29.5% as very good and good in 27.3% compared to 0.0% and 15.4% in controls. This therapy is thus a useful complementary treatment option with no side effects.

The Influence of Various Parameters on the Success of Sensor-Controlled Scalp Cooling in Preventing Chemotherapy-Induced Alopecia.

BACKGROUND: The influence of systemic comorbidities on the success of scalp cooling during chemotherapy (CT) is widely unexplored. Comorbidities often require additional medication which itself can occasionally cause alopecia. This study investigates the influence of selected parameters on the efficacy of scalp cooling for the prevention of CT-induced alopecia. PATIENTS AND METHODS: 226 cancer patients were treated with various CT regimens in combination with sensor-controlled scalp cooling. 136 breast cancer patients received (neo)adjuvant therapy, and 76 of these patients received epirubicine and cyclophosphamide (4× EC 3w) followed by paclitaxel (12× T w). The following parameters were prospectively investigated: chemotherapy-induced alopecia, systemic comorbidities and co-medication, nicotine abuse, hair treatment, menopausal status, and trichologic status. RESULTS: Scalp cooling was successful (no or not visible hair loss; common toxicity criteria 0-1) in 65% of all patients, in 65% of the 136 breast cancer patients, and in 68% of the 76 patients receiving EC/T. In this subgroup, premenopausal patients (p = 0.009) and those without systemic comorbidities (p = 0.003), without co-medication (p < 0.001) and with high hair density (p = 0.038) showed less hair loss during CT; an effect was also seen for nicotine abuse (p = 0.023). Hair length and hair treatment had no significant influence. CONCLUSION: Sensor-controlled scalp cooling represents an effective addition to supportive cancer therapy. The success of scalp cooling depends on the applied CT regimen. Parameters like menopausal status, systemic comorbidities, medication, nicotine abuse, and original hair density also influence the outcome of hair loss prevention.

The incidence of complications by hysterectomy for benign disease in correlation to an assumed preoperative score.

BACKGROUND: Hysterectomies are preformed abdominally, vaginally, laparoscopic or with robotic assistance. When choosing the route of hysterectomy, the physician should take into consideration the safest and most cost-effective route to fulfill all needs of the patient. METHODS: Data were collected retrospectively from 953 patients who underwent hysterectomy between 2002 and 2010 for benign indications at UKSH, Germany. Preoperative risk scores were assigned to patients. The data were statistically evaluated to investigate relationship between the occurrence of the complication and the preoperative score at the time of the hysterectomy. For the preoperative score, patients who had undergone a previous laparoscopy were assigned 1 point; those who had undergone a previous Pfannenstiel laparotomy were assigned 2 points; those who had undergone 1 cesarean delivery were assigned 3 points; those who had undergone 2 cesarean deliveries were assigned 4 points; those who had undergone 3 cesarean deliveries were assigned 5 points; and those with no previous operations were assigned 0 points. The preoperative score was recorded for 785 patients. RESULTS: Of the 785 women with complete data, the mean preoperative score was 1.09 ± 1.51 for AH, 0.75 ± 0.96 for VH, 1.04 ± 1.30 for LSH, 1.0 ± 1.40 for LAVH, and 1.38 ± 1.52 for TLH. The prevalent scores in the VH were 0 and 1, the LASH and TLH showed a prevalence over VH in the preoperative scores 3 and 4 and AH showed a prevalence over the other methods in the preoperative score 3-8. Intraoperative complications were recorded in 28 of 953 (2.9 %) cases: 10 (35.7 %) cases of VH; 13 (46.4 %) cases of AH; 3 (10.7 %) cases of LSH; 1 (3.6 %) case of LAVH; and 1 (3.6 %) case of TLH. The intraoperative complications appeared to be more frequently with heavier uterine weight showing a significant statically correlation (P < 0,001). Major postoperative complications occurred in 17 of 953 (1.8 %) cases. Minor postoperative complications were recorded in 56 of 953 (5.9 %) hysterectomies. Operation duration, hospital stay and hemoglobin decline correlated significantly with preoperative score (P < 0.001). CONCLUSION: The suggested preoperative score is apparently successful in screening out the high-risk patients, despite the low incidence of intra and postoperative complications. The usefulness of the preoperative scoring system is worthy of further development and evaluation. The AH was favored as the 'fallback option' with high preoperative score.