Safety and performance of the new med-el total ossicular replacement prostheses.

PURPOSE: This multicentric, retrospective study provides safety and performance data of the MED-EL total ossicular replacement prostheses (TORP). METHODS: Patients underwent tympanoplasty with mXACT Total Prosthesis Center, mXACT Total Prosthesis Offcenter or mXACT PRO Total Prosthesis. The clinical data were retrospectively analyzed. Follow-up examination included access to the medical record (for adverse events) of the patients, ear microscopy and pure-tone audiometry to determine the post-operative pure tone average of the frequencies 0.5, 1, 2 and 3 kHz (PTA4). The post-operative PTA4 air bone gap (ABG) was used to evaluate the audiological outcome. A post-operative minimum and maximum follow-up period was not defined. RESULTS: 103 patients were implanted with a TORP. 102 (88 adults, 14 children; 37 CHL, 64 MHL, 1 not specified) patients were analyzed for safety and 92 (79 adults, 13 children) patients for performance of the prostheses. ADVERSE EVENTS RESULTS (N = 102): In 1 patient (child, mXACT Total Prosthesis Offcenter) a prosthesis dislocation was reported, which lead to a revision surgery. No prosthesis extrusion or migration was reported. AUDIOLOGICAL RESULTS (N = 92): 49 (53.3%) of the 92 patients had a PTA4 ABG of ≤ 20 dB and therefore a successful rehabilitation. The mean post-operative PTA4 ABG of all 92 patients was 21.0 ± 9.7 dB. The first endpoint, improvement in post-operative PTA4 ABG of ≤ 20 dB by ≥ 25% of the patients was achieved. The individual Δ BC PTA4 (post-operative minus pre-operative BC PTA4) thresholds were stable (within ± 5 dB HL) in 91 (98.9%) patients. 1 patient had a BC PTA4 deterioration of 11.3 dB HL. CONCLUSION: The MED-EL TORPs are safe and effective for middle ear reconstruction. Trial registration number NCT05565339, September 09, 2022, retrospectively registered.

Short-term safety and effectiveness of the mCLIP partial prosthesis.

PURPOSE: This multicentric, retrospective study aimed to analyze the short-term safety and effectiveness of the mCLIP Partial Prosthesis. METHODS: Patients underwent tympanoplasty with implantation of a mCLIP Partial Prosthesis. Follow-up examination included ear microscopy and pure-tone audiometry to determine the post-operative pure tone average of the frequencies 0.5, 1, 2 and 3 kHz (PTA4). The post-operative PTA4 air bone gap (ABG) was used to evaluate the audiological outcome. A post-operative minimum and maximum follow-up period was not defined. Thus, the follow-up times of each study center were different, which resulted in different follow-up times for the audiological analysis and for adverse events (AE). RESULTS: 72 (66 adults, 6 children) patients were implanted with the mCLIP Partial Prosthesis. 68 (62 adults, 6 children) patients underwent audiological examination; all 72 patients were examined for adverse events. All patients (N = 68): 72.1% of the patients showed a PTA4 ABG of ≤ 20 dB. Individual post-operative bone conduction (BC) PTA4 thresholds were stable in 67 patients. The mean post-operative follow-up time was 78 ± 46 days. Children (N = 6): 5 out of 6 children showed a PTA4 ABG of ≤ 20 dB. None of the children reported a BC PTA4 deterioration of > 10 dB HL after the implantation. The mean post-operative follow-up time was 101 ± 45 days. Adverse events (all patients, N = 72): 15 (14 adults, 1 child) patients had AEs (27 AEs and 2 Follow-Ups). The mean post-operative follow-up time was 375 days. CONCLUSION: Clinical data show satisfactory audiological parameters after implantation of the mCLIP Partial Prosthesis. The prosthesis is safe and effective for implantation in children and adults. TRIAL REGISTRATION NUMBER: NCT05565339, 09 September 2022, retrospectively registered.

MRI and PET/CT in the assessment of lymph node metastases in head and neck cancer.

The aim of this study is to present the diagnostic accuracy of MRI and PET/CT in the evaluation of cervical lymph nodes in patients with head and neck cancer (HNC). Data of 114 patients who underwent MRI and PET/CT prior to surgery in the time period between January 2010 and September 2021 in our center is analyzed retrospectively. Histopathological results of surgical preparations serve as the gold standard. The mean time from MRI to surgery is 22.9 (± 18.7) days, and from PET/CT to surgery 21.7 (± 19.9) days. Sensitivities of 80.4% and 80.4%, specificities of 85.7% and 87.3%, PPVs of 82.0% and 83.7% and NPVs of 84.4% and 84.6% are registered for MRI and PET/CT, respectively. 37 false results are further analyzed with respect to side and level of the affected lymph node, as well as intersections of the two imaging modalities. In 29 patients (25.4%), additional findings are described in PET/CT, 7 (6.1%) of which were histologically confirmed to be further malignancies. A combination of both MRI and PET/CT imaging modalities could improve diagnostic accuracy, especially with regard to sensitivity. A notable number of additional findings in whole body acquisition leads to the potential diagnosis of further malignancies.

SARS-CoV-2 in the Middle Ear-CovEar: A Prospective Pilot Study.

In post-mortem analyses, SARS-CoV-2 was found in the middle ear of some, but not all, patients with COVID-19. It is not clear whether SARS-CoV-2 penetrated the ear passively post mortem, or existed in the middle ear of living patients during, and perhaps also after, infection. This study investigated whether SARS-CoV-2 can be found in the middle ear of living patients during ear surgery. Swabs from the nasopharynx, the filter connected to the tracheal tube and secretions from the middle ear were collected during middle ear surgery. All samples were tested for the presence of SARS-CoV-2 using PCR. History of vaccination, COVID-19 history and contact with SARS-CoV-2-positive individuals were recorded preoperatively. Postoperative SARS-CoV-2 infection was noted at the follow-up visit. Overall, 63 participants (62%) were children and 39 (38%) were adults. SARS-CoV-2 was found in the middle ear and in the nasopharynx of two and four CovEar study participants, respectively. The filter connected to the tracheal tube was sterile in all cases. Cycle threshold (ct) values of the PCR test were between 25.94 and 37.06. SARS-CoV-2 penetrated the middle ear of living patients and was found in asymptomatic patients. The presence of SARS-CoV-2 in the middle ear may have implications for ear surgery and can pose a risk of infection for operating room staff. It may also directly affect the audio-vestibular system.

Effective treatment of solitary rectal ulcer syndrome using argon plasma coagulation.

Solitary rectal ulcer syndrome (SRUS) is a chronic, multiform, non-cancerous disorder of the rectum, the final diagnosis of which is based upon histopathological criteria. This disorder is often accompanied by latent proctoptosis. We present a patient who (in 1996) was the first case in which argon plasma coagulation (APC) was used for SRUS treatment. In the years 2004-2005 the same patient underwent 15 APC sessions (at monthly intervals) obtaining full recovery from SRUS, although she had been treated unsuccessfully for 17 years prior to that. Six-year observation did not show any relapse. Local therapy with APC seems to be an important alternative in SRUS treatment without prolapse of the rectum and could become a basic method for bleeding treatment in SRUS.

[Solitary rectal ulcer syndrome]. / Zespól samotnego wrzodu odbytnicy.

Solitary rectal ulcer syndrome (SRUS) is a chronic, benign, polymorphic disease of the rectum, the final diagnosis of which is based on histopathologic criteria. Microscopic examination shows glandular changes, oedema and obliteration of the normal architecture in the region of the lamina propria, with muslce fibre penetrating into lamina. Although SRUS pathogenesis is bound up with defecation disorder, it still remains unclear. Disease symptoms are nonspecific--in most cases defecation disorders appear (incomplete defecation, blood and mucus in stool). In some patients emotional disorders can be observed. SRUS treatment is a complex and long-lasting process. Usually it is ineffective or gives only passing effects. SRUS can often be accompanied by rectal prolapse, sometimes a hidden one. In these cases there are more therapeutic possibilities and the prognosis is slightly better. There is no method of choice for SRUS treatment and the prognosis is hard to predict. The treatment should be selected individually, depending on the symptoms intensity and the occurrence of rectal prolapse.