The use of self-assembling peptides (PuraStat) for hemostasis in cervical endocrine surgery. A real-life case series of 353 patients.

INTRODUCTION: Cervical endocrine surgery is frequent and carries the risk of rare but potentially life-threatening bleeding complications. Energy-based devices for stopping bleeding are not always usable in contact with nerves or parathyroid glands. Topical hemostatic agents may be an additional resource. PuraStat™, made of the self-assembling peptide RADA16, forms a new category of topical hemostatic agents. OBJECTIVE: To assess the performance and safety of PuraStat to achieve hemostasis in cervical endocrine surgery. METHODS: A retrospective chart review over four years was performed on 353 patients undergoing thyroidectomy and/or parathyroidectomy by a single senior surgeon, using PuraStat at the end of surgery in contact with recurrent nerves and parathyroid glands. RESULTS: 353 patients (79.06% female, mean age 54 years) underwent surgery with six weeks follow-up visit. Three patients had revision surgery for hematoma within the first 4 h (0.84%), which is within the low ranges reported in the literature. There was no delayed bleeding after 24 h, and dysphonia was observed in 15 patients, more severe for 2 patients (one unilateral and one bilateral palsy), and transient for the other 13 patients suggesting no product-related damage to the recurrent nerves. Hypocalcemia with clinical signs were reported in 8 cases. There were no unexpected adverse events. CONCLUSION: This is the first report of the use of PuraStat in patients undergoing cervical endocrine surgery, showing high performance and safety in achieving hemostasis and in preventing delayed bleeding without damage to the recurrent nerves. Further randomized controlled studies are needed to confirm the results.

Post-operative benefits of Tisseel(®)/Tissucol (®) for mesh fixation in patients undergoing Lichtenstein inguinal hernia repair: secondary results from the TIMELI trial.

PURPOSE: The Tisseel/Tissucol for mesh fixation in Lichtenstein hernia repair (TIMELI) study showed that mesh fixation with human fibrin sealant during inguinal hernia repair significantly reduced moderate-severe complications of pain 12 months post-operatively compared with sutures. Further analyses may assist surgeons by investigating predictors of post-surgical complications and identifying patients that may benefit from Tisseel/Tissucol intervention. METHODS: Univariate and multivariate analyses identified risk factors for combined pain, numbness and groin discomfort (PND) visual analogue scale (VAS) score 12 months post-operatively. Variables tested were: fixation method, age, employment status, physical activity, nerve handling, PND VAS score at pre-operative visit and 1 week post-operatively. The effect of fixation technique on separate PND outcomes 12 months post-surgery was also assessed. Analyses included the intention-to-treat (ITT) population and a subpopulation with pre-operative PND VAS > 30 mm. RESULTS: 316 patients were included in the ITT, with 130 patients in the subpopulation with pre-operative PND VAS > 30. Multivariate analysis identified mesh fixation with sutures, worsening pre-operative PND and worsening PND 1 week post-surgery as significant predictors of 12-month PND in the ITT population; mesh fixation with sutures was a significant predictor of 12-month PND in the pre-operative PND VAS > 30 subpopulation (p < 0.05). Mesh fixation with Tisseel/Tissucol resulted in significantly less numbness and a lower intensity of groin discomfort compared with sutures at 12 months; there was no difference in pain between the treatment groups. CONCLUSIONS: Pre-operative discomfort may be an important predictor of post-operative pain, numbness and discomfort. Tisseel/Tissucol may improve long-term morbidity over conventional sutures in these patients.

An animal model to train Lichtenstein inguinal hernia repair.

PURPOSE: Inguinal hernia repair is a common surgical procedure, and the majority of operations worldwide are performed ad modum Lichtenstein (open tension-free mesh repair). Until now, no suitable surgical training model has been available for this procedure. We propose an experimental surgical training model for Lichtenstein's procedure on the male and female pig. METHODS: In the pig, an incision is made 1 cm cranially to the inguinal sulcus where a string of subcutaneous lymph nodes is located and extends toward the pubic tubercle. The spermatic cord is located in a narrow sulcus in the pig, thus complicating the procedure if operation should be done in the inguinal canal. The chain of lymph nodes resembles the human spermatic cord and can be used to perform Lichtenstein's hernia repair. RESULTS: This experimental surgical model has been tested on two adult male pigs and three adult female pigs, and a total of 55 surgeons have been educated to perform Lichtenstein's hernia repair in these animals. CONCLUSIONS: This new experimental surgical model for training Lichtenstein's hernia repair mimics the human inguinal anatomy enough to make it suitable as a training model. The operation facilitates the training in the positioning and fixation of the mesh and can be performed numerous times on the same pig. It is therefore a useful training method for inexperienced surgeons to obtain experience in aspects of the Lichtenstein procedure.

Fibrin sealant in inguinal hernioplasty: an observational multicentre study in 1,201 patients.

PURPOSE: A prospective, multicentre, observational study was undertaken to assess Tisseel fibrin sealant for atraumatic mesh fixation in inguinal hernia repair throughout France. METHODS: Surgeons recorded data on patients undergoing tension-free inguinal hernioplasty with mesh fixation with Tisseel, regardless of the hernioplasty technique used. Assessments were made at 2 days and 1 month after surgery. Data on local complications, operation times and ease of product use were collected. RESULTS: In total, 1,201 patients were recruited (90% men, mean age 57 years), among which 526 procedures were performed using open techniques and 675 using laparoscopic repairs. Local complications occurred in 4.7% of patients: 3.0% haematoma, 1.4% seroma, 0.3% recurrence. The mean visual analogue scale (VAS)-rated pain scores were 3.2 pre-operatively, 2.3 immediately after surgery and 1.8 at 1 month. Surgeons rated the product as very easy to use. CONCLUSIONS: Tisseel fibrin sealant appears to be a well-tolerated and easy-to-use alternative to traditional, tissue-penetrating devices for mesh fixation in hernia repair techniques.

[Intravenous immunoglobulin (Endobulin) clinical tolerance: prospective therapeutic follow-up of 142 adults and children]. / Tolérance clinique d'une préparation thérapeutique d'immunoglobulines humaines polyvalentes à usage intraveineux (Endobuline): suivi prospectif d'une population de 142 adultes et enfants.

PURPOSE: Prospective report of Endobulin clinical tolerance experience for 19 months over a large number of patients. METHOD: Collect diagnosis, age, gender, weight, dose regimen, infusion duration, and clinical tolerance of Endobulin. Treatment with this product was the only inclusion criteria in this follow-up. RESULTS: A hundred and forty-two patients, 85 children and 57 adults, mean age 23 (1-85 years) received 70 substitutive treatments for primary immunodeficiency, 36 substitutive treatments for secondary immunodeficiency and 36 immunomodulatory treatments. A thousand six hundred and sixty Endobulin infusions that led to 14, 061.5 g, from 52 different batches. Tolerance was judged as good for 135 patients even though side effects occurred in 2 of them. Thus, 133 out of 142 patients, that is 93.7% did not present any side effect and their tolerance to Endobulin infusions was defined as good. Tolerance was bad for 7 patients because of side effects occurrence. For a mean number of 11.7 infusions per patient (1-31), the 9 side effects observed led to a rate of 0.54% of collected infusions and 6.3% of patients included. CONCLUSION: This therapeutic follow-up of 142 patients confirms Endobulin clinical tolerance judged as good in 93.7% of patients (133/142) with a very low rate of side effects of 0.54% of infusions (9 side effects for 1660 infusions) for a mean number of 11.7 infusions per patient for an average of 10.9 months follow-up.

Micro macroporous biphasic ceramics and fibrin sealant as a moldable material for bone reconstruction in chronic otitis media surgery. A 15 years experience.

Bone reconstruction is still a matter of concern in middle ear surgery despite the large number of surgical techniques proposed. Combination of biphasic calcium phosphate bioceramics with human fibrin sealant forms a moldable material easy to apply for bone reconstruction. Since 1986, we have been using this composite for reconstruction of mastoid cavities during chronic otitis media surgery. Granules of ceramic provide immediate mechanical stability and later on, promote osseoinduction when fibrin sealant forms a strong bond between granules enhancing the wound healing process. After checking feasibility, efficacy and tolerance through a controlled study on dogs by filling mastoid cavities, we started a clinical series comprising yet 66 mastoid reconstructions. A retrospective data analysis on 63 patients with an average follow up of 42 months including 12 histological controls confirms the stability of bone reconstruction with a remarkable tolerance of the skin in contact. Biopsies confirmed progressive replacement of material by lamellar newly formed bone. Mastoid cavities have a randomed shape making complex bone reconstruction procedure and their filling by the composite constitutes an easy way and represents a highly satisfactory procedure. The authors considered that this should be explored in other indications of bone surgery.

[The otolaryngologist and Creutzfeldt-Jakob disease]. / L'oto-rhino-laryngologiste et la maladie de Creutzfeldt Jakob.

Is the ENT surgeon guilty of being a vector in Creutzfeldt-Jakob disease (CJD) in the past, present and future, with possible medico-legal implications, by virtue of his use of biomaterials and of his failure to sterilise surgical instruments adequately? Once the disease has been diagnosed, are there any implications for ENT? CJD is the most frequent clinical manifestation of the infectious subacute spongiform encephalopathies. It is invariably fatal within a few months, and at present there is no known treatment. Currently the diagnosis can be confirmed only by brain biopsy, but diagnostic tests are being developed. The causative agent belongs to the group of non-conventional transmissible agents, or prions, which are resistant to all conventional sterilisation methods. The illness has a long incubation period extending to several years, during which the abnormal prion protein (PPr), derived from a protein which is normally present, accumulates in the central nervous system. CJD is a rare condition, affecting less than one in a million of the population, and manifests itself in one of three distinct ways: sporadic, in 90% of cases, possibly due to a natural mutation of the gene responsible for formation of the protein, hereditary familial (5 to 10% of cases); and iatrogenic, transmitted by the implantation of biomaterials of human origin, which are the cases for which the ENT surgeon could be responsible, and which may affect any age group. The possible modes of ENT transmission have been identified. These could be the use of surgical material contaminated by a patient suffering from CJD, the use of human biomaterials whether dural homografts, ossicular homografts taken together with the donor dura, the use of blood products, or the use of biomaterials of bovine origin. Such materials have been used widely in the past without any observed increase in new CJD cases, but the incubation period of this disease is not well understood. A knowledge of the possible alternatives and of the new relations on the subject should allow us to improve the epidemiology of the condition, help the surgeon in his choice of materials, help in the diagnosis of the condition, and in avoiding its transmission by heeding new advice on sterilisation.

Macroporous biphasic calcium phosphate efficiency in mastoid cavity obliteration: experimental and clinical findings.

Following our previous experimental studies on the performance of macroporous biphasic calcium phosphate (MBCP) in canine mastoid cavities, we used this material in patients requiring surgical intervention. Twenty-two cases were selected, and in eight specific cases a biopsy specimen was taken. Histologic, ultrastructural, and microanalysis studies were performed. This study demonstrates the effectiveness of MBCP implants as bone graft substitutes for mastoid cavity obliteration. Clinical evaluation of the series and histologic and ultrastructural results demonstrated the bioactivity and osteo-conduction of this material, with partial transformation of MBCP granules into lamellar bone after several months.

[Anastomosis of the facial nerve using fibrin glue, apropos of 60 cases]. / Anastomose du nerf facial par colle de fibrine exclusive, à propos de 60 cas.

The facial nerve was repaired with only fibrin glue anastomosis in 60 cases. The facial nerve was repaired by end-to-end (21 cases) or cable graft (28 cases) anastomosis. In 11 cases, a hypoglosso-facial anastomosis was performed. Grade 3 facial regeneration was observed in 62% of cases after one year follow-up. End-to-end or cable graft anastomosis provided the best results when the anastomosis were glued into the petrous bone or the parotid. The anastomosis should be performed without tension and the vascularization of nerve should be preserved if possible.

[Are auditory prostheses a contraindication to magnetic resonance imaging?]. / Les prothèses auditives sont-elles une contre-indication à l'I.R.M.?

Prior to the use of nuclear magnetic resonance imaging (NMRI) in patients with metallic ossicular prostheses their compatibility must be investigated with the intense magnetic fields generated by NMRI. Implanted auditory prostheses are an absolute contraindication to NMRI, but an experimental study of its possible interaction with metallic stapedial prostheses has shown absence of their displacement. The artefact induced may alter images of middle ear but do not affect internal auditory canal. Nevertheless, manufacturers should conduct tests of magnetism of prostheses before they are passed as satisfactory.

Experimental and clinical aspects of carbon as a middle ear prosthesis.

The biocompatibility of vitreous carbon and carbon fibre reinforced carbon (CFRC) as middle ear implants was investigated. In separate animal model systems, vitreous carbon was implanted in the middle ear of 20 DA rats for up to 6 months, whilst 3 varieties of CFRC (basic or crude, ultrasonically cleaned, glazed) were implanted in 98 guinea-pig middle ears for up to 4 months. Tissue reactions to implantation were assessed by means of stereoscopic and standard light microscopy, and scanning electron microscopy with chemical analysis facilities (EDAX, WDAX). Vitreous carbon and glazed CFRC were considered suitable for human implantation and a trial of the latter was started in 23 patients (14 partial, 9 total ossicular implants). At 9 months, only 52% of the implants were still in situ; 40% had been extruded and 8% had elicited inflammatory responses which would undoubtedly result in extrusion. Carbon particle dissemination with carbon fibre destruction and exposure as a result of peroperative prosthesis drilling were considered the likely causes for the failure of this implant.

The role of Eustachian tube function in the results of tympanoplasty.

While the Eustachian tube constitutes by its functions of equipression, ventilation and drainage one of the determining elements of sound transmission, it is too the one on which it is the most difficult to take effect. Eustachian tube dysfunctions' persistence after tympanoplasty interfere, by negative pressure in the tympanic cavity, with the good quality of the results as anatomical as functional. Valuation of the tubal function, its keeping and its restoration, before, per- and after operation, must constitute for the otologist a permanent objective.