This study investigates the use of tissue-soldering techniques to substitute or reinforce traditional suture closure of dural incisions. Fresh human cadaveric dura was incised and subsequently closed by use of three techniques: (1) conventional interrupted suture with 4-0 silk (n = 25), (2) laser solder reinforced suture closure (n = 25), and (3) laser solder closure alone (n = 25). Anastomosis tensile strength and hydrostatic leak pressures were measured. Dural repair was also performed in 15 live Lewis rats. Dural closure was accomplished with 9-0 Prolene sutures (n = 5), laser-reinforced suture closure (n = 5), and laser solder closure alone (n = 5). Histologic examination of the closure immediately after soldering and 2 weeks later was performed. Suture closure alone had the lowest leak pressure, 9.4 +/- 1.7 mm Hg, and an intermediate break point, 13.3 +/- 2.1 Kgf/cm2. Measurements with laser solder alone revealed a mean leak pressure of 26.2 +/- 3.7 mm Hg and a break point of 4.6 +/- 1.4 Kgf/cm2. Solder-reinforced suture closure leak pressure measured 64.0 +/- 6.7 mm Hg and 21.4 +/- 2.4 Kgf/cm2. There was a statistically significant increase in leak pressure and tensile strength in the closures performed with laser weld reinforcement of traditional suture technique (p = 0.0001). Dural closure with laser tissue welding alone provided an immediate leak-free closure, but with poor tensile strength. Histologic examination of welded dura and underlying brain tissue showed no evidence of thermal injury in four of five animals studied. Laser welding may significantly decrease the incidence of cerebrospinal fluid leak after dural closure. In addition, laser tissue welding also makes dural closure possible where space constraints make traditional suture closure difficult.
Cerebrospinal fluid (CSF) otorrhea is a relatively rare entity that may occur either as a spontaneous occurrence or as a result of trauma or surgery. Spontaneous CSF leaks may be found during tympanocentesis, myringotomy, or tube insertion for chronic middle ear effusion. Rapid identification of the problem and timely treatment are required to avoid life-threatening complications such as meningitis. The site of leakage must also be identified so that the disorder can be treated effectively. Computed tomography, magnetic resonance imaging, and radionucleotide localization scanning all play a role in the early identification of the leakage site. A detailed knowledge of possible CSF leakage pathways aids in evaluating imaging studies. We report 2 rare cases of CSF otorrhea through a congenitally patent facial canal and their management.
The Vibrant Soundbridge/Vibrant Med-El can be safely implanted using the minimal access method that has been popularized for cochlear implant surgery. A large incision, extensive hair shave, risk of flap necrosis, and possibility of unsightly scar may deter patients from pursuing the potential benefits of implanted hearing technology. The technique may make the device more accessible to individuals who have concerns regarding cosmetics and potential flap complications.
Purpose
Partial ossicular replacement (PORP) and total ossicular replacement prostheses (TORP) are used to restore ossicular chain function. Despite favorable auditory outcomes, these interventions have associated risks and complications. This study examines the FDA MAUDE database for ossicular chain prosthesis adverse events to highlight complications, interventions, and root cause analysis (RCA) findings.
Materials and methods
The MAUDE database was searched for Medical Device Reports (MDRs) relating to PORPs and TORPs from 2010 to 2020. MDR event descriptions were reviewed, and adverse events were identified as a device issue, patient issue, and/or packaging issue that occurred intraoperatively or postoperatively.
Results
Our search identified 70 MDRs which included 110 reported adverse events. Events consisted of 63 device issues, often due to device breaks and displacements, 39 patient issues, including common complaints of hearing loss and erosion, and 8 packaging issues. When comparing PORPs and TORPs, TORPs had more reported device issues whereas PORPs had more packaging issues. Intraoperative device issues were commonly resolved by completing the procedure with a backup device and most postoperative device issues required additional surgery. For devices returned to the manufacturer, RCA determined that most breaks were caused by modification and/or mishandling or that the product met specifications with an undetermined cause for the break.
Conclusion
Device issues were the most common adverse events and frequently required subsequent intervention. Displacement occurred more often with TORPs and was associated with changes in hearing or erosion. The findings of this study are purely descriptive and may not have direct clinical relevance.
All three patients were successfully implanted, with full electrode insertion achieved. All patients subsequently became active implant users. One patient did suffer from a minor wound complication post-operatively, unrelated to the approach. Patient follow up ranged from four to six years.
When faced with challenging temporal bone anatomy, intraoperative CT can provide critical details of the patient's microanatomy that allows for improved localization of the electrode and adjustments in operative techniques for successful cochlear implantation.
We report thecaseofa49-year-oldman whopresentedwith left auralfullness, hearing loss, and a stenoticleft external auditorymeatus.Physicalexaminationand computedtomographyrevealed thepresence ofan idiopathicossification of the cartilaginous auricle and externalauditory canal. The patient was successfully treated with meatoplasty. Pathologic examinationoftheremovedspecimen revealed osseous metaplasia.
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