Autoinflation for treatment of persistent otitis media with effusion in children: a cross-over study with a 12-month follow-up.

OBJECTIVES: The aims of the present study were to evaluate the efficacy of and compliance with a new device for autoinflation in the treatment of persistent otitis media with effusion (OME) in young children. METHODS: Forty-five children with persistent OME with a bilateral type B or C2 tympanogram for at least three months and history of subjective hearing loss, waiting for grommet surgery, were randomised to a treatment and a control group. Twenty-three children aged between three and eight years started as the treatment group with the new device for autoinflation. Another 22 children, aged between two and eight years were included as controls. After a period of four weeks, a cross-over was performed. Both groups underwent otomicroscopy, tympanometry and audiometry at inclusion and after one and two months for the evaluation of treatment efficiency. The primary outcome measurements were improvement in middle-ear pressure and hearing thresholds at eight weeks. Both groups were then followed up for another 10 months. RESULTS: In the treatment group, the mean middle-ear pressure for both ears and the mean hearing thresholds for the best ear improved by 166 daPa (p<0.0001) and 6 dB (p<0.0001), respectively after four weeks, while in the control group, non-significant alterations were observed. After the cross-over of the control group to treatment, equivalent improvements in the mean middle-ear pressure and the mean hearing thresholds of 187 daPa (p<0.0001) and 7 dB (p<0.01), respectively were achieved also in this group. After treatment in both groups at eight weeks, four of 45 children were submitted to grommet surgery. During the long-term follow-up another five children were submitted to surgery due to recurrence of disease. All the children managed to perform the manoeuvre and no side-effects were detected. CONCLUSION: The device demonstrated efficiency in improving both middle-ear pressure and hearing thresholds in most children after four weeks of treatment. It might therefore be possible to consider this method of autoinflation in children with persistent OME during the watchful waiting period.

Replacement of a tracheal stenosis with a tissue-engineered human trachea using autologous stem cells: a case report.

Cell-based therapies involving tissue engineering represent interesting and potentially important strategies for the treatment of patients with various disorders. In this study, using a detergent-enzymatic method, we prepared an intact three-dimensional scaffold of an extracellular matrix derived from a human cadaver donor trachea, which we repopulated with autologous stem cells and implanted into a 76-year-old patient with tracheal stenosis including the lower part of the larynx. Although the graft provided the patient with an open airway, a week after the surgery, the mucous membrane of the graft was covered by a 1-2 mm thick fungal infection, which was treated with local and systemic antifungal therapy. The airway lumen was postoperatively controlled by fiber endoscopy and found stable and sufficient. However, after 23 days, the patient died due to cardiac arrest but with a patent, open, and stable tracheal transplant and intact anastomoses. Histopathological results of the transplanted tracheal graft during autopsy showed a squamous but not ciliated epithelium, neovascularization, bundles of α-sma-positive muscle cells, serous glands, and nerve fibers with S-100-positive nerve cells in the submucosa and intact chondrocytes in the cartilage. Our findings suggest that although autologous stem cells-engineered tracheal matrices may represent a tool for clinical tracheal replacement, further preclinical studies are required for generating functional airway grafts and long-term effects of such grafts.

Transplantation of an allogeneic vein bioengineered with autologous stem cells: a proof-of-concept study.

BACKGROUND: Extrahepatic portal vein obstruction can have severe health consequences. Variceal bleeding associated with this disorder causes upper gastrointestinal bleeding, leading to substantial morbidity and mortality. We report the clinical transplantation of a deceased donor iliac vein graft repopulated with recipient autologous stem cells in a patient with extrahepatic portal vein obstruction. METHODS: A 10 year old girl with extrahepatic portal vein obstruction was admitted to the Sahlgrenska University Hospital in Gothenburg, Sweden, for a bypass procedure between the superior mesenteric vein and the intrahepatic left portal vein (meso Rex bypass). A 9 cm segment of allogeneic donor iliac vein was decellularised and subsequently recellularised with endothelial and smooth muscle cells differentiated from stem cells obtained from the bone marrow of the recipient. This graft was used because the patient's umbilical vein was not suitable and other strategies (eg, liver transplantation) require lifelong immunosuppression. FINDINGS: The graft immediately provided the recipient with a functional blood supply (25-30 cm/s in the portal vein and 40 mL/s in the artery was measured intraoperatively and confirmed with ultrasound). The patient had normal laboratory values for 9 months. However, at 1 year the blood flow was low and, on exploration, the shunt was patent but too narrow due to mechanical obstruction of tissue in the mesocolon. Once the tissue causing the compression was removed the graft dilated. We therefore used a second stem-cell populated vein graft to lengthen the previous graft. After this second operation, the portal pressure was reduced from 20 mm Hg to 13 mm Hg and blood flow was 25-40 cm/s in the portal vein. With restored portal circulation the patient has substantially improved physical and mental function and growth. The patient has no anti-endothelial cell antibodies and is receiving no immunosuppressive drugs. INTERPRETATION: An acellularised deceased donor vein graft recellularised with autologous stem cells can be considered for patients in need of vascular vein shunts without the need for immunosuppression. FUNDING: Swedish Government.

Prosthetic reconstruction from the tympanic membrane to the stapes head or to the stapes footplate? A laser Doppler study.

BACKGROUND: In the absence of the incus, many surgeons believe that reconstruction from the tympanic membrane to the stapes head is more effective than reconstruction to the stapes footplate. This has rarely been tested empirically. Published better clinical results with reconstruction to the stapes head might simply reflect less underlying disease in ears with an intact stapes superstructure. OBJECTIVE: To compare vibration transmission of these two forms of prosthetic reconstruction. METHODS: A fresh human cadaveric temporal bone model was used. Round window vibrations in response to sound in the ear canal were measured with a laser Doppler vibrometer. After incus removal, the discontinuity was repaired using a titanium prosthesis. Reconstruction from the tympanic membrane to the stapes head was compared to reconstruction to the stapes footplate. RESULTS: Reconstruction of both types decreased round window vibrations by 10 to 15 dB between 500 and 3000 Hz compared to the intact middle ear. Reconstruction to the stapes head performed 5 to 10 dB better at lower frequencies (500-2000 Hz), but this was only statistically significant at 1 and 2 kHz. CONCLUSIONS: There is only a 5 to 10 dB mechanical advantage gained by reconstruction from the tympanic membrane to the stapes head compared to reconstruction to the footplate for frequencies between 1 and 2 kHz.

Effect of Silastic sheeting over the round window niche on sound transmission in the intact human middle ear.

BACKGROUND: Silastic sheeting is commonly used in middle ear surgery to prevent the formation of adhesions between the tympanic membrane and the medial bony wall of the middle ear cavity. This sheeting is often placed, advertently or inadvertently, so as to cover the round window niche. The effects of mechanically shielding the round window niche in the presence of an intact tympanic membrane and ossicular chain have not been empirically studied to date. OBJECTIVE: To investigate the effect of acoustically shielding the round window with 1 mm thick Silastic sheeting on middle ear sound transmission in otherwise intact cadaveric human temporal bones. METHODS: Using a fresh human cadaveric temporal model, a computerized laser Doppler vibrometry system was used to measure vibrations at the umbo and on the stapes footplate in response to sound introduced into the ear canal. Stapes displacement was used as a measure of sound transmission. The measurements were repeated after shielding the round window using 1 mm thick Silastic sheeting. RESULTS: We found that shielding the round window with Silastic produced no significant difference in the measurements at the stapes footplate. At the umbo, a slight increase in vibrations at 250 to 500 Hz was measured after shielding. This was on the order of 3 dB and was not statistically significant. CONCLUSION: In the presence of an intact tympanic membrane and ossicular chain, shielding the round window with Silastic sheeting has no clinically significant effect on sound transmission by the human middle ear.

Accelerated radiotherapy for advanced laryngeal cancer.

The purpose of this study was to evaluate a single institution's outcome for patients with advanced laryngeal cancer treated with accelerated radiotherapy (RT). Fifty-eight patients with advanced laryngeal cancer (T3/T4N0/N + M0) were treated with curative intent with accelerated RT during the period 1990-1998. Patients received radiotherapy alone or with induction chemotherapy. The 5-year local control (LC) and loco-regional control (LRC) probabilities were both 49% for T3 and 75% for T4 tumors. The 5-year disease-free survival probability was 46% and 68% and overall survival probability was 30% and 39% for T3 and T4 tumors respectively. No significant statistical difference in outcome was found, either between T3 and T4 tumors, or between patients who received induction chemotherapy and those who did not. The treatment results for advanced laryngeal cancer at this institution were comparable to those reported in the literature. The results for T3 and T4 were similar. T4 classification alone should not be an exclusion criterion for larynx preservation. Overall survival was poor, partly because of a high incidence of deaths from intercurrent diseases.

Functional long-term outcome of a free jejunal transplant reconstruction following chemoradiotherapy and radical resection for hypopharyngeal and proximal oesophageal carcinoma.

BACKGROUND/AIMS: To evaluate the functional outcome of a reconstruction by a free vascularized jejunal transplant combined with a voice prosthesis after chemoradiotherapy and surgery for proximal oesophageal or hypopharyngeal cancer. METHODS: Seven patients (6 men, mean age 52 years, range 28-70) with squamous cell cancer in the proximal oesophagus (n = 6) or the hypopharynx received preoperative chemoradiotherapy (40.8 Gy, cisplatinum and 5-FU) followed by a circumferential pharyngolaryngectomy and resection of the proximal oesophagus. A single-stage reconstruction was carried out with a free jejunal transplant using a microsurgical technique. A tracheojejunal puncture and insertion of a voice prosthesis (Provox I) was performed after 3 months in suitable cases. RESULTS: All operations had a per- and postoperative uneventful course. Five patients were alive after a mean follow-up time of 5 years and 7 months after surgery (range 3 years 4 months to 7 years 10 months), while 2 patients died from metastases within 2 years after surgery. Postoperative examination showed histopathological down-staging in all cases. Relief of dysphagia was achieved in most cases. Good or average speech was recorded in 3 patients. CONCLUSION: Reconstruction after radical resection for proximal oesophageal and hypopharyngeal cancer can be carried out with low mortality, acceptable morbidity and a promising functional outcome.

Obstructive sleep apnea caused by bilateral vocal fold paralysis.

We describe the case of a woman who had been referred to us with a history of breathing difficulties and snoring and a suspicion of obstructive sleep apnea (OSA). Our investigation revealed that she did indeed have severe OSA in addition to undiagnosed bilateral vocal fold paralysis of unknown origin. Nocturnal polysomnography found that her apnea/hypopnea index was 120 and her minimum arterial oxygen saturation level was 63%. She was treated with laterofixation of the right vocal fold, and her OSA resolved immediately. During 10 years of follow-up with nocturnal polysomnogrpahy, no recurrence of apnea or low oxygen saturation levels was noted. However, she did experience a recurrence of her snoring 4 years postoperatively, along with the onset of progressively worsening daytime fatigue. When these conditions persisted, we performed a repeat laterofixation of the same vocal fold. Following the repeat surgery, subjectively and objectively assessed results were good.

Improvement in neuropsychological performance following surgical treatment for obstructive sleep apnea syndrome.

Obstructive sleep apnea syndrome (OSAS) is characterized by snoring and apnea during sleep leading to decreased oxygen saturation and disturbed sleep, excessive daytime sleepiness and neuropsychological disturbances. This study investigates cognitive neuropsychological abilities in a group of 53 OSAS patients before and after treatment with uvulopalatopharyngoplasty. General intellectual ability, verbal learning and memory as well as executive functioning were measured at baseline and 6 months postoperatively. After surgery there were significant improvements in verbal learning and memory (mean change -39, SD 57.3, p < 0.001), recall (mean change -24.3, SD 39.3, p < 0.001) and executive functioning (as assessed by percentage of errors on the Wisconsin Card Sorting Test; mean change -9.1, SD 15.7, p < 0.001). These improvements were in accordance with improvements in the degree of sleep apnea, the oxygen desaturation index (mean change -9.7, SD 15.9, p < 0.001) and arterial minimum oxygen saturation (mean change 4.5%, SD 10.2%, p < 0.01). Surgical treatment seems to improve verbal learning, memory and recall and executive functions in parallel with better oxygenation in OSAS.