Patient-reported experience with hypoglossal nerve stimulation in the treatment of obstructive sleep apnea.

BACKGROUND: Breathing-synchronized hypoglossal nerve stimulation (HNS) is routinely used as an alternative treatment for patients with obstructive sleep apnea (OSA). Significant and clinically relevant improvements in disease severity and OSA symptoms such as daytime sleepiness as well as overall quality of life have been reported in randomized-controlled trials and large real-world cohort studies. However, so far, few data exist on patient-reported experience with the treatment. METHODS: A structured survey with 22 questions was constructed using five-level Likert scales (1 = no agreement, 5 = complete agreement) to evaluate patient experience with HNS and perception of the treatment in the domains "Overall experience with therapy," "Experience with treatment process," and "Side-effects from treatment." Additional data were collected on current symptom status, measured with Epworth sleepiness scale (ESS) questionnaire, and OSA disease history. Multiple linear regression analysis was conducted to test associations of medical variables and response behavior. Correlations between variables and domains, as well as individual items, were assessed using Spearman rank test. RESULTS: A total of 75 patients from Germany who were treated with breathing-synchronized HNS were enrolled (mean age 57.3 years, 78% male), and 71 questionnaires with complete data were included for analysis. Two-thirds of participants (67%) had a history of OSA history for 5 years or longer. Of all patients, 76% had normalized OSA symptoms at time of the study (ESS: 6.4 ± 5.0) and 98% reported using stimulation therapy every night. Regression analysis revealed an association of current symptoms measured with ESS and response behavior. Hence, patients with normalized daytime sleepiness reported significantly more positive experience across all domains assessed, compared to patients with residual daytime sleepiness. Overall, only 2% of participants reported side effects that made them reduce or discontinue stimulation therapy. The rate of reported side effects was associated with current symptom control under therapy. CONCLUSIONS: Overall patient-reported experience with breathing-synchronized HNS therapy was positive and high satisfaction with the treatment process was observed. Side effects occurred, but rarely affected subjective use of the therapy or satisfaction. Subjective experience and perception are influenced by residual daytime sleepiness with stimulation therapy.

Clinical comparison of postoperative results of balloon kyphoplasty (BKP) versus radiofrequency-targeted vertebral augmentation (RF-TVA): a prospective clinical study.

INTRODUCTION: Osteoporotic vertebral fractures are a frequent occurrence in geriatric traumatology. Differences in the achievement of pain reduction and restoration of the height of the vertebral body after balloon kyphoplasty (BKP) or radiofrequency-targeted vertebral augmentation (RF-TVA) were to be tested on a randomized population. METHODS: A total of 80 patients (f = 59; m = 21) with osteoporotic fractures of vertebral bodies were assigned to the groups BKP (n = 44) or RF-TVA (n = 36). The clinical analyses were compared peri- and postoperatively in a prospective study with an additional follow-up examination after 1 year. RESULTS: The operations for BKP were bipedicular in all cases; for RF-TVA, a bipedicular access was required in only five cases (14 %) (p>0.0001). There were confirmed differences with respect to the amount of cement used (ml) between the two groups (BKP = 4.9 ± 1 vs. RFTVA= 3.4 ± 1; p<0.001). In the BKP group, the angle of kyphosis was reduced by an average of 1.65° and in the RF-TVA group by an average of 2.8° by the operation. The analysis of the maximum VAS data showed a clear postoperative reduction in the intensity of pain of approximately 4.5 cm in each of the groups with no discernible difference. After 12 months, the majority of patients in both groups (BKP = 61 % vs. RF-TVA = 83 %) reported being free of pain when at rest without a significant difference(p = 0.05). CONCLUSIONS: A certain superiority of RF-TVA with respect to pain relief, amount of cement required, savings of operating time and personnel, and greater safety with respect to cement leakage noted in this study are consistent with other published literature. The differences between the two methods in the frequency of subsequent postoperative fractures and the secondary loss of high restoration were encouraging regarding RF-TVA.

[Clinical aspects of the problem of vertebral metastases, possibilities of modern treatment methods, considering especially radiofrequency ablation]. / Klinische Aspekte zur Problematik der Wirbelkörpermetastasen, Möglichkeiten moderner Behandlungsmethoden unter besonderer Berücksichtigung der Radiofrequenzablation.

From 100,000 people in Germany, statistically calculated, 441 males and 350 females suffer from a cancer disease. In about 50 to 80 % of patients with breast or prostate carcinoma bone metastases are registered, which is connected, among others, with a high risk for pathological fractures and other debilitating diseases. The diagnosis of bone metastases is done by conventional X-ray equipment, CT, MRI, and especially with the help of skeletal scintigraphy. For therapy bisphosphonates, anti-hormones and chemotherapeutic agents as drugs are used. Furthermore, radiotherapy, radionuclides, surgery and ablative procedures are applied. A more recent technical method is the STAR™ Tumour Ablation System (RFA), by which minimally invasively an electrode is introduced into the vertebral bodies. The system ensures precise control and thus a targeted ablation of the metastases. Several publications and reports describing a combined application demonstrate the synergistic effectiveness of RFA and radiofrequency kyphoplasty.

Treatment options for vertebral fractures an overview of different philosophies and techniques for vertebral augmentation.

PURPOSE: For more than 30 years, minimally invasive surgical procedures have been available to stabilize the fractured vertebrae by cement augmentation leading to significant pain relief, a distinct improvement in quality of life and decreased mortality for patients suffering from osteoporotic vertebral compression fractures. This overview article is designed to provide information on the wide range of augmentation methods previously tested and clinically applied in surgery in an attempt to compile the clinically relevant information on safety and efficacy in the published literature. METHOD: Based on an extensive literature review on the topic of "vertebral fractures--surgical augmentation techniques" we summarized the results of published clinical trials and experimental testing which address clinically relevant questions. The selection of the publications in reference books and scientific journals covers the time period from the end of the 1970s until the present. RESULTS: The final selection of more than 50 publications with, in the opinion of the authors, clinically relevant data led to the following results, which can be of significance for clinical application. The prerequisites for the success of all augmentation methods include the earliest possible surgical intervention, optimal technical equipment and an experienced, interdisciplinary team, as well as thorough consideration of the situation of the individual patient. The selection of the material for vertebral augmentation depends on the surgical method. The material of choice remains polymethylmethacrylate (PMMA), and the best record of efficacy and safety is displayed by radiofrequency kyphoplasty with ultrahigh-viscosity cement. Regarding clinical efficacy and safety, there are many convincing documentations showing superiority of vertebroplasty and kyphoplasty in comparison with conservative therapeutic regimens. Initial results of clinical studies with additional implants indicate a trend toward further improvement in clinical success and suggest possible broader clinical possibilities of application. CONCLUSION: Modern, minimally invasive augmentation techniques represent a real alternative to conservative treatment of patients with vertebral fractures. Further technical and clinical development in this area should aim at optimizing procedural safety while continuing to achieve comparably good results to current methods. Minimizing damage to the remaining trabecular structures as well as to adjacent vertebral disks and vertebrae should be paramount of importance. SUMMARY: Options for the treatment of vertebral fractures: Reductions in bone density and pathological changes in bone structure are associated with an elevated risk of fractures, which can lead to decisive functional impairment, pain, and a host of further comorbidities. Vertebral augmentation can be considered as an alternative conservative treatment, in order to achieve immediate and lasting pain relief as well as improvement in functional impairment. To achieve greater safety, instrumentation for transpedicular access and incorporation of radiopacifiers in PMMA for vertebroplasty were developed in mid-eighties. Balloon kyphoplasty was introduced in the end nineties, and results of prospective, randomized clinical studies have confirmed the safety and efficacy; the destruction of the remaining native spongiosa structures during balloon expansion is viewed as a disadvantage of this method. The two step method of cavity creation followed by cement delivery known as kyphoplasty has been further refined and developed by and varied by technology/procedural developments. This includes most the radiofrequency kyphoplasty (DFINE Inc., San Jose, CA, USA), in which ultrahigh-viscosity cement is delivered at a controlled delivery rate, following producing a bone sparing size and side specific cavity which minimizes loss of spongiosa, allowing for mechanical stability upon interdigitation of cement into that remaining trabecular bone. This combination has been shown to preserve vertebral structures and reduces the risk of leakages. Finally, systems have been available in which cement augmentation of implants to enhance mechanical stability of the implants or the overall fracture is constructed by load sharing.

[Reimbursement for kyphoplasty in the Germann diagnosis-related groups system 2011/2012. Material costs versus treatment costs]. / Vergütung der Kyphoplastie im DRG-System 2011/2012. Materialkosten vs. Versorgungskosten.

BACKGROUND: The treatment of osteoporotic vertebral fractures by means of kyphoplasty is an accepted and safe procedure. AIM: In Germany the reimbursement for kyphoplasty and vertebroplasty differs greatly. The growing diversity of suppliers and systems makes a comparison possible and necessary. Besides the illustration of kyphoplasty in the German diagnosis-related group (G-DRG) system and the amendments for 2012 we analyzed the procedures and associated costs. METHOD: Using the example of two manufacturers and different system approaches, both of which can be charged as kyphoplasty, we try to point out the importance of selecting exact comparison parameters. In particular material and treatment costs are compared for both methods.

[Revenue and losses with vertebral augmentation under the G-DRG system 2012 - a comparison of supply costs in the context of vertebroplasty and kyphoplasty]. / Ertrag und Verlust bei vertebralen Augmentationen im G-DRG-System 2012 - Ein Vergleich des Versorgungsaufwands bei Vertebroplastie und Kyphoplastie.

BACKGROUND: If clearly indicated and implemented, augmentations of vertebral bodies with cement are standardized, safe and low-risk procedures. However, the multiplicity of providers and systems are today more varied than ever. At present, the systems differ starkly from one another not only in specifications, possible applications and extensions of indications, but they are also extremely variable in price. Publications have shown that in times of medical-economic change, vertebral augmentations make sense not only medically, but also in terms of economics and the national economy. Our analysis targets the question of how insurance costs with vertebroplasty and kyphoplasty affect profit margins per G-DRG (German Diagnosis Related Groups) in consideration of the different system approaches of the providers. MATERIALS AND METHODS: After reviewing the literature, extremely varied, minimally invasive augmentation methods and techniques for treating vertebral body fractures were identified and classified. These were grouped based also [sic: on] OPS and possibly further subdivisions. Material costs were gathered based on average price quotations of different providers and techniques and aligned with those from the literature. The inpatient costs per day were estimated as a lump sum according to published information, since our analysis was interested in less detailed process costs as these are difficult to transfer to other clinics due to parameters being unique to each facility. The G-DRGs concerned were likewise determined according to the case-based lump sum catalogue from 2012. Based on this, the material costs as well as the daily costs per day of inpatient stay according to the average length of stay per G-DRG were subtracted. RESULTS: Vertebral augmentation methods are classified into vertebroplasty and kyphoplasty according to OPS. In addition, according to current literature, a further subdivision of kyphoplasty into substance-conserving or direct cement injection techniques and substance-destroying or indirect cement injection techniques took place. The procedures involve material costs between 10-40 % of G-DRG revenue. The profit margin of vertebral augmentation ranges from approx. 4100 € to approx. 11 400 €. The calculative costs of the inpatient care per day amount to 488.86 €. Based on the average lengths of stay per G-DRG (7.8-12.6 days) for 2012 determined by the InEK (Institut für das Entgeltsystem im Krankenhaus [Institute for the Hospital Remuneration System]), the financial costs of inpatient care were calculated between 3813.11 € and 6159.65 €. A shortfall of -197.53 € for the treatment of a vertebral body resulted for the vertebroplasty. This shortfall increases with the treatment of three vertebral bodies and a PCCL = 4 to -466.30 €. The indirect cement injection techniques accounted for a positive profit margin of 196.03 € for the treatment of a vertebra. Due to high material costs, however, this dips into the negative in the amount of -1227.70 € for two vertebrae and increases to -2522.50 € for the treatment of three vertebral bodies. In contrast, the multilevel care in substance-preserving kyphoplasty techniques show a positive profit margin of 72.30 € for the treatment of two vertebrae and 577.50 € for the treatment of three vertebrae. CONCLUSION: Against the background of the increasing economization of the health care system, it should be emphasized once more that the decision for a therapy or a system based on medical reasons should only be made by the treating physician. The vertebroplasty could not be performed at a profit in our analysis, despite comparatively low material costs. A shortfall between -197.53 € and -466.30 € was determined. The comparatively higher material costs of the kyphoplasty make comparisons important. The results of our investigation also show that supposedly inexpensive purchases of materials are not automatically a favorable alternative. In addition, the kyphoplasty techniques currently available on the market are not necessarily comparable. According to our investigation, profits of between 196.03 € and 577.50 € are to be realized in the selection of vertebral augmentation systems based on purely economic considerations. The results of our analysis show that the pure comparison of figures of the average material costs of a G-DRG and the material price distort the picture. A calculation of the profit margin on the basis of costs of care per vertebral body is more definitive.

[Operative treatment of instable osteoporotic spine fractures. A good guide in coding of diagnosis]. / Operative Versorgung instabiler osteoporotischer Wirbelsäulenfrakturen. Eine wichtige Kodierhilfe.

The combination of kyphoplasty and fixateur interne is an essential therapy with osteoporotic unstable fractures. Material costs of 5500 Euro are not sufficiently covered by returns through DRG I09. Thus operations are often performed in 2 stages, an initial one and a second 30 days later. This means more strain for the patient and partly also loss of correction. Therefore in 2008 we requested the InEK that codes for one-and two-segmental implantation of material in a vertebrae with preceding restoration of vertebral height (5-839.a0 and 5-839.a1) combined with a percutaneous dorsal operation with a screw-rod system in the future would be represented by I19B in G-DRG system with returns of 11,110,40 Euro. Prerequirement is coding of kyphoplastiy as main procedure and percutaneous implantation of a fixateur with procedure 5-835.5. Some procedures in orthopedic surgery implying technical improvements and rising implant costs are not sufficiently rewarded. Thus is make sense to inform InEK by corresponding proposals.

[Plastic surgery of defects of the thoracic wall]. / Plastische Deckung von Thoraxwanddefekten.

Defects of the thoracic wall are mostly due to a malignant disease of the mammary gland. Radiotherapy is one of the essential methods of treating cancer of the breast in addition to primary surgery. If, after surgery, healing occurs by secondary intention or if there is a local recurrence or tumour formation in the thoracic wall due to irradiation, the body's reserves of soft parts are often exhausted and the adjacent tissue has been additionally damaged by the irradiation. General principles of treatment in the management of such problems are presented by means of several case reports.

Prevalence of risk factors of coronary heart disease in Turks living in Germany: The Giessen Study.

Turkish people represent the majority of immigrants in Germany. Even though a high proportion of Turks has been living in Germany since about 20 years, little is known about risk factors of coronary heart disease (CHD) in this population. In this study a sample of 325 male and 155 female Turks are investigated, who voluntarily underwent a health check-up in Germany. Data about the presence of CHD, risk factors and blood parameters were collected. Mean residence time was 21 and 17 years (males/females). A low percentage of female participants was observed compared to the general Turkish population in Germany. Age adjusted prevalence of CHD reached 9.5% in males and 6.7% in females, respectively. Dyslipoproteinemia (DLP) showed the highest prevalence of all risk factors investigated in both genders. Total cholesterol (TC) levels were comparable to those of other western countries and remarkably higher than reported for the population in Turkey. Besides this, low high density lipoprotein-cholesterol (HDL-C) and apolipoprotein A-I (ApoA-I) levels could be found in the majority of the sample. The highest odds ratios for CHD were estimated for stress and hypertension in males and obesity in females. It is concluded that Turkish immigrants in Germany showed an assimilation of lipid pattern to western populations. However, reasons for low HDL-C levels remain unclear. Changes in the lipid metabolism chiefly seem to contribute to the risk factor pattern of Turkish immigrants in Germany.