Guided placement of zygomatic implants in head and neck cancer patients: implant survival and patient outcomes at 1-3 years of follow-up.

Zygomatic implants (ZI) are a valuable option for supporting an obturator prosthesis after maxillary resection. This study was performed to assess the clinical outcomes of a digitally validated guided technique for ZI placement, followed by immediate prosthetic obturation. The primary objective was to evaluate implant survival, while the secondary objective was to assess patient-reported quality of life post-rehabilitation. Twelve patients treated for head and neck cancer received a total of 36 ZI after ablative surgery. The mean duration of ZI follow-up was 30.1 months. The survival rate of ZI placed in non-irradiated patients was 100%, while it was 85% in irradiated patients. Patient-reported outcomes were evaluated using the Liverpool Oral Rehabilitation Questionnaire (LORQv3) and the University of Washington Quality of Life Questionnaire (UW-QOL v4). Most patients reported satisfactory outcomes in the oral function domain of the LORQv3 (mean score 17.7 ± 4.5; possible range 12-48, with lower scores indicating better outcomes). Regarding the UW-QOL v4, the swallowing and chewing domains had the highest scores (mean 97.5 ± 8.7 and 95.8 ± 14.4, respectively; maximum possible score of 100). In conclusion, this treatment approach improves function and quality of life after maxillary ablative surgery. However, irradiated patients showed a noticeable trend of higher implant failure, and this was influenced by tumour position and size impacting the radiation dose to the zygomatic bone.

Recombinant human C1 inhibitor for the prophylaxis of hereditary angioedema attacks: a pilot study.

BACKGROUND: Hereditary angioedema (HAE) is a disease characterized by recurrent tissue swelling affecting various body locations. Recent literature shows that patients with frequent attacks may benefit from long-term prophylaxis. This study evaluated the safety and prophylactic effect of weekly administrations of recombinant C1INH (rhC1INH). METHODS: Patients with a history of HAE attacks occurring ≥every 2 weeks received a once weekly administration of 50 U/kg rhC1INH. Hereditary angioedema attack history was collected at screening. Breakthrough attacks during the study were recorded at each visit. Following a 2-week run-in period, HAE patients received 8 weekly rhC1INH administrations and were followed-up for an additional 6 weeks. Efficacy was evaluated by comparing the HAE attack incidence during the treatment period to the historical attacks over the previous 2 years. Safety evaluation was based on clinical laboratory and adverse events (AEs) reports. RESULTS: The 25 participants reported a mean of 0.9 attacks/week over the past 2 years. The mean breakthrough attack rate during the treatment period was 0.4 attacks/week (95% CI 0.28-0.56). A total of 30 treatment-emergent-AEs were reported in 13 patients, all mild to moderate. One patient died from a laryngeal attack 25 days after last study drug administration. The only possible drug related AEs reported were dry mouth, dizziness and anxiety in one patient and hypotension in another. There were no allergic AEs and no neutralizing antibodies observed. CONCLUSIONS: Weekly administrations of 50 U/kg rhC1INH appeared to reduce the frequency of HAE attacks and were generally safe and well tolerated.

Efficacy and safety of recombinant human C1-inhibitor for the treatment of attacks of hereditary angioedema: European open-label extension study.

BACKGROUND: Hereditary angioedema (HAE) owing to C1 inhibitor deficiency is an autosomal dominant disorder, characterized by recurrent, potentially life-threatening, localized attacks of tissue swelling. Current treatment involves the infusion of C1 inhibitor protein (C1-INH) isolated from human plasma. OBJECTIVES: This open-label extension to a European, Israeli and Argentinean randomized study (NCT00262301) aimed to investigate the efficacy and safety of recombinant human C1 inhibitor (rhC1-INH) as a first-line treatment following an HAE attack, together with its effect on subsequent attacks. METHODS: An HAE-specific visual analogue scale (VAS) 0-100 mm was used by patients to assess the severity of attack at four anatomical locations. Patients were treated with one, single-vial, fixed-dose of rhC1-INH (2100 U), followed by up to two further vials at the investigators discretion. The primary end-point was the time from first rhC1-INH injection to first onset of relief of symptoms (≥ 20 mm decrease on VAS). Response to treatment was defined as the onset of relief within 4 h. RESULTS: A total of 57 patients were treated for 194 HAE attacks. Overall, sustained relief of symptoms was achieved in 87% of rhC1-INH-treated patients within 4 h of treatment, with 57% of attacks requiring only one vial of rhC1-INH. When categorized by successive attacks experienced by individual patients, the response rate to rhC1-INH treatment was 96%, 83%, 87%, 80% and 80% for attacks 1-5 respectively. Treatment with rhC1-INH was well tolerated, with no discontinuations owing to treatment-emergent adverse events and no adverse events relating to immunogenicity. CONCLUSIONS AND CLINICAL RELEVANCE: Treatment with rhC1-INH provides fast-onset relief for an HAE attack, with a high rate of therapeutic response maintained throughout subsequent attacks.

Immediate implant-retained prosthetic obturation after maxillectomy based on zygomatic implant placement by 3D-guided surgery: a cadaver study.

BACKGROUND: The aim of this study was to introduce a complete 3D workflow for immediate implant retained prosthetic rehabilitation following maxillectomy in cancer surgery. The workflow consists of a 3D virtual surgical planning for tumor resection, zygomatic implant placement, and for an implant-retained prosthetic-obturator to fit the planned outcome situation for immediate loading. MATERIALS AND METHODS: In this study, 3D virtual surgical planning and resection of the maxilla, followed by guided placement of 10 zygomatic implants, using custom cutting and drill/placement-guides, was performed on 5 fresh frozen human cadavers. A preoperatively digitally designed and printed obturator prosthesis was placed and connected to the zygomatic implants. The accuracy of the implant positioning was obtained using 3D deviation analysis by merging the pre- and post-operative CT scan datasets. RESULTS: The preoperatively designed and manufactured obturator prostheses matched accurately the per-operative implant positions. All five obturators could be placed and fixated for immediate loading. The mean prosthetic point deviation on the cadavers was 1.03 ± 0.85 mm; the mean entry point deviation was 1.20 ± 0.62 mm; and the 3D angle deviation was 2.97 ± 1.44°. CONCLUSIONS: It is possible to 3D plan and accurately execute the ablative surgery, placement of zygomatic implants, and immediate placement of an implant-retained obturator prosthesis with 3D virtual surgical planning.The next step is to apply the workflow in the operating room in patients planned for maxillectomy.

[Diagnostic image (377). A man with bilateral swelling on the lingual surface of the mandible]. / Diagnose in beeld (377). Een man met een bilaterale zwelling aan de linguale zijde van de onderkaak.

A 41-year-old man was referred with a bilateral swelling on the lingual surface of the mandible, due to torus mandibularis.

mTHPC mediated photodynamic therapy (PDT) of squamous cell carcinoma in the head and neck: a systematic review.

OBJECTIVE: Photodynamic therapy (PDT) is used in curative and palliative treatment of head and neck squamous cell carcinoma (HNSCC). To evaluate available evidence on the use of mTHPC (Foscan®) mediated PDT, we conducted a review of the literature. MATERIALS AND METHODS: A systematic review was performed by searching seven bibliographic databases on database specific mesh terms and free text words in the categories; "head and neck neoplasms", "Photodynamic Therapy" and "Foscan". Papers identified were assessed on several criteria by two independent reviewers. RESULTS: The search identified 566 unique papers. Twelve studies were included for our review. Six studies reported PDT with curative intent and six studies reported PDT with palliative intent, of which three studies used interstitial PDT. The studies did not compare PDT to other treatments and none exceeded level 3 using the Oxford levels of evidence. Pooling of data (n=301) was possible for four of the six studies with curative intent. T1 tumors showed higher complete response rates compared to T2 (86% vs 63%). PDT with palliative intent was predominantly used in patients unsuitable for further conventional treatment. After PDT, substantial tumor response and increase in quality of life was observed. Complications of PDT were mostly related to non-compliance to light restriction guidelines. CONCLUSION: The studies on mTHPC mediated PDT for HNSCC are not sufficient for adequate assessment of the efficacy for curative intent. To assess efficacy of PDT with curative intent, high quality comparative, randomized studies are needed. Palliative treatment with PDT seems to increase the quality of life in otherwise untreatable patients.

The embryonic diapause of Aulocara elliotti (Orthoptera, Acrididiae). Histological and morphometric changes during diapause development and following experimental termination with juvenile hormone analogue.

Progressive hypertrophy of fat body, muscles, gonads and pleuropodial glands was observed with lengthening diapause incubation in embryos of Aulocara elliotti. Embryonic hemolymph stained more darkly and lipoid materials accumulated in the fat body and other tissues. Gradual increase in volumes was observed in the corpora cardiaca, corpora allata and ventral head glands (ecdysial glands). Termination of diapause was achieved in embryos treated with juvenile hormone analogue (JHA) (4 ethyl phenyl 6.7 epoxy geranyl ether--87%, Stauffer Chemical) applied directly to the egg undiluted or when eggs were immersed in a 10% solution in methanol. Treated embryos terminating diapause underwent rapid teratological morphogenesis, achieving pigmentation and sclerotization as in definitive embryos without engulfing their yolk. In treated embryos which remained in diapause, unusual paired masses of pigmented cells, resembling the melanotic pseudotumors of Drosophila, were observed ventral and lateral to the stomodeum and are thought to be subesophageal body cells (pericardial cell homologues). In some embryos these cells were enlarged, lysed or their nuclei rhexic and pycnotic. This response suggests these cells are target organs for JHA, or perhaps for ecdysone or its precursor released by JHA treatment. Endocrine glands in treated embryos had significantly larger volumes (.01) than those of controls or untreated embryos. The ventral head glands of treated embryos appeared to be cytoplasmically depleted. It is suggested that JHA triggered the release of stored ecdysone (or its precursor produced in the ventral head gland) at a rate too rapid for normal morphogenetic processes, such as dorsal closure, to accompany epidermal maturation. The response to JHA cannot be interpreted as juvenilization, but rather must be considered to be precocious maturation. These results indicate that: 1. diapause development involves a transfer of nutrient materials from the yolk into the fat body and other embryonic tissues where they are available to meet the demands of post-diapause morphogenesis; 2. that embryonic diapause in A. elliotti is a consequence of endocrine deficiency which probably results ultimately from the lack of neurosecretory stimulus from the brain-corpora cardiaca complex; and 3. that the subesophageal body cells, and perhaps the pericardial cells, play an essential role in the embryonic physiology, perhaps in the production of carrier protein and/or an essential growth regulator.