Clinical Outcomes of Soft Tissue Preservation Surgery With Hydroxyapatite-Coated Abutments Compared to Traditional Percutaneous Bone Conduction Hearing Implant Surgery-A Pragmatic Multi-Center Randomized Controlled Trial.

Background: Soft tissue preservation using a hydroxyapatite-coated abutment in bone conduction hearing implant surgery may lead to improved clinical outcomes over the short (1 year) and long term (3 years). Methods: In this open multi-center, randomized (1:1), controlled clinical trial, subjects with conductive, mixed hearing loss or single-sided sensorineural deafness were randomly assigned to receive the conventional intervention, a titanium abutment with soft tissue reduction surgery (control), or a new intervention, a hydroxyapatite-coated abutment with soft tissue preservation surgery (test). The primary efficacy outcome was the combined endpoint of numbness, pain, peri-abutment dermatitis, and soft tissue thickening/overgrowth after 1 and 3 years. Results: The Intention-to-treat (ITT) population consisted of 52 control subjects and 51 test subjects. The difference between the groups after 1 year of follow-up as measured by the primary efficacy outcome was not statistically significant (p = 0.12) in the ITT population (n = 103), but did reach statistical significance (p = 0.03) in the per-protocol (PP) population (n = 96). It showed an advantage for the test group, with over twice as many subjects (29%) without these medical events during the first year compared to the control group (13%). After 3 years, the difference between the two groups had declined and did not reach statistical significance (24 vs. 10%, ITT p = 0.45). Secondary outcome measures which showed a statistical significant difference during the first year, such as surgical time (15 vs. 25 minutes, p < 0.0001), numbness (90 vs. 69% of subjects experienced no numbness at 1 year, p < 0.01), neuropathic pain at 3 months (p = 0.0087) and the overall opinion of the esthetic outcome (observer POSAS scale at 3 months, p < 0.01) were favorable for the test group. More soft tissue thickening/overgrowth was observed at 3 weeks for the test group (p = 0.016). Similar results were achieved for the long term follow up. Conclusions: Soft tissue preservation with a hydroxyapatite-coated abutment leads to a reduction in the combined occurrence of complications over the first year which is not statistically significant in the ITT population but is in the PP population. This effect decreased for the long-term study follow up of 3 years and did also not reach statistical significance.

Indirect costs related to caregivers' absence from work after paediatric tonsil surgery.

Tonsillotomy has gradually replaced tonsillectomy as the surgical method of choice in children with upper airway obstruction during sleep, because of less postoperative pain and a shorter recovery time. The aim of this study was to examine the costs related to caregivers' absenteeism from work after tonsillectomy (TE) and tonsillotomy (TT). All tonsillectomies and tonsillotomies in Sweden due to upper airway obstruction during 1 year, reported to the National Tonsil Surgery Register in children aged 1-11 were included, n = 4534. The number of days the child needed analgesics after surgery was used as a proxy to estimate the number of work days lost for the caregiver. Data from the Social Insurance Agency (Försäkringskassan) regarding the days the parents received temporary parental benefits in the month following surgery were also analysed. The indirect costs due to the caregivers' absenteeism after tonsillectomy vs tonsillotomy were calculated, using the human capital method. The patient-reported use of postoperative analgesic use was 77% (n = 3510). Data from the Social Insurance Agency were gathered for all 4534 children. The mean duration of analgesic treatment was 4.6 days (indirect cost of EUR 747). The mean number of days with parental benefits was 2.9 (EUR 667). The indirect cost of tonsillectomy was 61% higher than that of tonsillotomy (EUR 1010 vs EUR 629). The results show that the choice of surgical method affects the indirect costs, favouring the use of tonsillotomy over tonsillectomy for the treatment of children with SDB, due to less postoperative pain.

Post-tonsillectomy haemorrhage rates are related to technique for dissection and for haemostasis. An analysis of 15734 patients in the National Tonsil Surgery Register in Sweden.

OBJECTIVES: To analyse post-tonsillectomy haemorrhage (PTH) rates related to technique for dissection and haemostasis. STUDY DESIGN: Register study from the National Tonsil Surgery Register in Sweden (NTSRS). METHODS: All patients, subjected to tonsillectomy (TE) without adenoidectomy from 1 March 2009 to 26 April 2013, were included in the study. The surgeon reports data about technique and early PTH, while late PTH is reported by the patient in a questionnaire 30 days after surgery. RESULTS: 15734 patients with complete data concerning technique for dissection and for haemostasis were identified in the NTSRS. Techniques used were cold steel dissection with uni- or bipolar diathermy haemostasis (65.3%), diathermy scissors (15.7%), coblation (9.1%), cold steel dissection with cold haemostasis (7.4%) and ultrascision (2.5%). Early and late PTH were reported in 3.2% and 9.4% of the cases, respectively, and return to theatre (RTT) in 2.7%. The rates for PTH and RTT related to technique were analysed. Compared with cold dissection+ cold haemostasis, late PTH rate was 2.8 times higher after cold dissection + hot haemostasis, 3.2 times higher after coblation, 4.3 times higher after diathermy scissors and 5.6 times higher after ultrascision. The risk for RTT was higher for all hot techniques except for coblation, while ultrascision resulted in a lower risk for early PTH. CONCLUSIONS: All hot techniques resulted in a higher risk for late PTH compared with cold steel dissection +cold haemostasis. The risk for RTT was higher for all hot techniques except for coblation, while ultrascision resulted in a lower risk for early PTH. An early PTH was associated with an increased risk for late PTH.

Infants under the age of six months with acute mastoiditis. A descriptive study of 15 years in Sweden.

OBJECTIVE: To investigate the occurrence, clinical signs and outcome of acute mastoiditis in infants under the age of 6 months in Sweden between the years 1993-2007. METHODS: All ENT departments in Sweden reported children 0-5 months treated for acute mastoiditis 1993-2007 and all records were reviewed. The clinical course and various characteristics were recorded. RESULTS: Seventeen young infants with acute mastoiditis were identified. Three patients had suffered acute otitis media earlier, otherwise the children were previously healthy. Preceding the episode of acute mastoiditis, the children had an upper respiratory tract infection or fever for seven days in mean (median three days) and the mean number of days with ear-symptoms was three days (median two days). Three patients were treated with antibiotics prior to admittance. Almost all children presented with clear retroauricular signs with protruding ear and redness behind the ear. The children were hospitalised for six days (mean and median). Eight patients (47%) suffered from a subperiosteal abscess. All but one patient underwent surgery: myringotomy (13); incision or punction of the mastoid (5); mastoidectomy (3). Streptococcus pneumoniae was the most frequent bacterium identified in cultures. No intracranial complications or other severe complications were found. CONCLUSION: Acute mastoiditis is extremely rare in infants under the age of 6 months. The patients in this study did not have any predisposing diseases. An upper respiratory tract infection had preceded the episode of acute mastoiditis for some time in the majority of cases, but the time from first ear symptoms to hospitalization was very short. Acute mastoiditis is a potentially life-threatening disease, but the timely administration of intravenous antibiotics and surgical intervention prevented the occurrence of severe complications in these young infants.

National assessment of validity of coding of acute mastoiditis: a standardised reassessment of 1966 records.

OBJECTIVES: To investigate the internal validity of the diagnosis code used at discharge after treatment of acute mastoiditis. DESIGN: Retrospective national re-evaluation study of patient records 1993-2007 and make comparison with the original ICD codes. SETTING: All ENT departments at university hospitals and one large county hospital department in Sweden. PARTICIPANTS: A total of 1966 records were reviewed for patients with ICD codes for in-patient treatment of acute (529), chronic (44) and unspecified mastoiditis (21) and acute otitis media (1372). MAIN OUTCOME MEASURES: ICD codes were reviewed by the authors with a defined protocol for the clinical diagnosis of acute mastoiditis. Those not satisfying the diagnosis were given an alternative diagnosis. RESULTS: Of 529 records with ICD coding for acute mastoiditis, 397 (75%) were found to meet the definition of acute mastoiditis used in this study, while 18% were not diagnosed as having any type of mastoiditis after review. Review of the in-patients treated for acute media otitis identified an additional 60 cases fulfilling the definition of acute mastoiditis. Overdiagnosis was common, and many patients with a diagnostic code indicating acute mastoiditis had been treated for external otitis or otorrhoea with transmyringeal drainage. CONCLUSIONS: The internal validity of the diagnosis acute mastoiditis is dependent on the use of standardised, well-defined criteria. Reliability of diagnosis is fundamental for the comparison of results from different studies. Inadequate reliability in the diagnosis of acute mastoiditis also affects calculations of incidence rates and statistical power and may also affect the conclusions drawn from the results.

Implant survival rate in bone-anchored hearing aid users: long-term results.

OBJECTIVE: To investigate the long-term survival rate of bone-anchored hearing aid implants, and to assess the number of patients who stop using their bone-anchored hearing aid. METHOD: Patients who underwent bone-anchored hearing aid surgery between September 1977 and December 1986 were identified from a prospective database. Data were collected from patient records. RESULTS: During the study period, 143 patients were fitted with a bone-anchored hearing aid. Records from 132 patients were found, with a mean follow up of nine years. A total of 150 implants were installed in these patients. A total of 41 implants (27 per cent) were lost during follow up: 17 lost osseointegration, 16 were removed and eight were lost due to direct trauma. At the end of follow up, 119/132 (90 per cent) patients were still using their bone-anchored hearing aid. CONCLUSION: Despite a high incidence of implant loss over time, a large number of patients still continued to use their bone-anchored hearing aid.

Nitric oxide production in the sphenoidal sinus by the inducible and constitutive isozymes of nitric oxide synthase.

OBJECTIVE: To study the production of nitric oxide (NO), and the presence of different isoforms of the NO-synthesising enzyme, NO-synthase (NOS), in the paranasal sinus. MATERIALS AND METHODS: Ten patients, undergoing surgery for pituitary adenoma, were examined for the presence of NO gas in the sphenoidal and maxillary sinus. The distribution of different NOS isozymes in mucosal biopsies from sphenoid and maxillary sinus and ethmoidal cells was studied. RESULTS: The mean concentration of NO was 2575 ppb in the sphenoidal sinus and 6792 ppb in the maxillary sinus. Morphological analyses revealed intense NADPH-diaphorase staining throughout the epithelium. Immunoreactivity against NOS2 (inducible NOS) was observed in the apical cell layer but not of the basal layer. NOS1 (neuronal NOS)-immunoreactivity was mainly seen in the subapical part of the epithelium and NOS3 (endothelial NOS)-immunoreactivity was observed only in the most apical part of the epithelium. CONCLUSION: NO concentration in the sphenoidal sinus is about the same as in the nasal cavity and approximately half of the concentration found in the maxillary sinus. All of the three main different isozymes of NOS can be demonstrated in the mucosa of the sphenoidal and maxillary sinus and ethmoidal cells, NOS2 being the most abundant isoform.

Accuracy of tele-oncology compared with face-to-face consultation in head and neck cancer case conferences.

Telemedicine was introduced for weekly tumour case conferences between Sahlgrenska University Hospital and two district hospitals in Sweden. The accuracy of tele-oncology was determined using simulated telemedicine consultations, in which all the material relating to each case was presented but without the patient in person. The people attending the conference were asked to determine the tumour ('TNM') classification and treatment. The patient was then presented in person, to give the audience the opportunity to ask questions and perform a physical examination. Then a new discussion regarding the tumour classification and the treatment plan took place, and the consensus was recorded. Of the 98 consecutive patients studied in this way, 80 could be evaluated by both techniques. Of these 80, 73 (91%) had the same classification and treatment plan in the telemedicine simulation as in the subsequent face-to-face consultation. In four cases the TNM classification was changed and for three patients the treatment plan was altered. The specialists also had to state their degree of confidence in the tele-oncology decisions. When they recorded uncertainty about their decision, it was generally because they wanted to palpate the tumour. In five of the seven patients with a different outcome, the clinical evaluation was stated to be dubious or not possible. The results show that telemedicine can be used safely for the management of head and neck cancers.

Haptic palpation of head and neck cancer patients--implication for education and telemedicine.

Malignancy in the head and neck area is a disease that often gives high morbidity in functions like speech, eating, breathing and cosmetics. To ensure a treatment of high clinical standard these patients are presented for a multidisciplinary tumor-team at Sahlgren University hospital. The team usually involves ENT-surgeons (Ear, Nose and Throat), oncologists, radiologists, pathologists, plastic surgeon, general surgeon and oral surgeons. The aim of the presentation is to classificate the tumor and suggests a treatment. The patients presented are from the whole western region of Sweden, and therefore some patients have to travel long distances. To minimize travel telemedicine was introduced 1998 with success [1]. One concern, when presenting a patient with telemedicine, has been the lack of possibility to palpate the tumor and the tissue surrounding it. To address this problem a 3D model of the tumor visualizes the region and possibly allows haptic palpation. Based on a series of high resolution CT/MR scans, a model of the region around the patients tumor is created. Haptic properties are added to the skin and subcutaneous structures (including the tumor) of the model. Initially, the haptic tuning is done by an examining physician, but in the final telemedical application, the aim is to develop a sensory device for this purpose (e.g. a position sensitive glove, such as Virtual Technologies, Inc. CyberGlove [2] and a graded system for setting firmness of the tissue). The model with its haptic properties can then be examined visually and haptically, the latter using a haptic device such as the SensAble PHANToM [3]. The present system uses a 3D model in VRML format based on reconstructed structures in the ROI (which includes the jawbones, the vertebra, the throat, major muscles and the skin) from high resolution CT. Haptic properties are added using MAGMA 2.5 (ReachIn Technologies AB, Sweden) [4]. Haptic force feedback is provided using a PHANToM Desktop (SensAble Technologies Inc) [3]. Visual feedback can be either monoscopic or stereoscopic (StereoGraphic CrystalEyes) [5]. The system will be used for concept testing and for evaluating possible limitations and/or the need for a modified examination protocol. Once a reliable set of parameters has been generated (using both professionals and medical students at various levels), the remote components will be added.