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Cochlear implant explantation: An in vitro model to evaluate electrode explant force and trauma

Asfour, Leena; Risi, Frank; Miah, Hanif; Roland, J Thomas
OBJECTIVES/UNASSIGNED:Removal of a cochlear implant and its intracochlear electrode array is sometimes necessary, potentially causing cochlear explant trauma. Explantation typically occurs years post-implantation by which time reactive tissue has formed around the electrode. We aimed to create an in-vitro electrode explant model to examine explant forces and intracochlear trauma across multiple electrode types and insertion depths. STUDY DESIGN/UNASSIGNED:An in-vitro model using gel to represent tissue surrounding the electrode was developed. Pre-curved electrodes and straight electrodes at different insertion depths (20mm, 25mm, 28mm) were explanted from the model. During explantation, explant force was measured, and high-definition videos were recorded to capture electrode exit path and gel disruption. RESULTS/UNASSIGNED:Explant force patterns varied based on electrode position in the scala tympani. Explant forces did not correlate with gel disruption, which represented explant trauma. The least gel disruption occurred with pre-curved electrodes and the under-inserted straight electrode. The greatest disruption occurred with the overly inserted straight electrode. CONCLUSION/UNASSIGNED:An in-vitro model using gel to mimic tissue surrounding the electrode may provide insights into potential electrode explant trauma. Explant force did not correlate with explant trauma in our model. Pre-curved electrodes and shallower insertion depth of a straight electrode resulted in the least amount of explant trauma.
PMID: 35236258
ISSN: 1754-7628
CID: 5174492

American Cochlear Implant Alliance Task Force Guidelines for Determining Cochlear Implant Candidacy in Children

Warner-Czyz, Andrea D; Roland, J Thomas; Thomas, Denise; Uhler, Kristin; Zombek, Lindsay
This article summarizes the available evidence on pediatric cochlear implantation to provide current guidelines for clinical protocols and candidacy recommendations in the United States. Candidacy determination involves specification of audiologic and medical criteria per guidelines of the Food and Drug Administration. However, recommendations for a cochlear implant evaluation also should maintain flexibility and consider a child's skill progression (i.e., month-for-month progress in speech, language, and auditory development) and quality of life with appropriately fit hearing aids. Moreover, evidence supports medical and clinical decisions based on other factors, including (a) ear-specific performance, which affords inclusion of children with asymmetric hearing loss and single-sided deafness as implant candidates; (b) ear-specific residual hearing, which influences surgical technique and device selection to optimize hearing; and (c) early intervention to minimize negative long-term effects on communication and quality of life related to delayed identification of implant candidacy, later age at implantation, and/or limited commitment to an audiologic rehabilitation program. These evidence-based guidelines for current clinical protocols in determining pediatric cochlear implant candidacy encourage a team-based approach focused on the whole child and the family system.
PMCID:8862774
PMID: 35213891
ISSN: 1538-4667
CID: 5172522

Improving Quality and Safety of Thyroidectomy [Meeting Abstract]

Papazian, M; Roland, J T; Shao, Q; Vaezi, A; DeLacure, M; Tran, T; Persky, M J; Persky, M S; Jacobson, A; Givi, B
Introduction: Thyroidectomy is commonly performed in otolaryngology. Complications such as recurrent laryngeal nerve (RLN) injury and severe hypocalcemia have reported incidences in national studies as high as 3% and 8%, respectively. Narcotic pain medications are commonly used for postoperative pain management. Here, we present the long-term results of a thyroidectomy quality and safety improvement program, with an emphasis on reducing narcotic use.
Method(s): All surgeons who perform thyroidectomy established standards for antibiotic administration, postoperative calcium management, and narcotics use. The program was established in 2018 and data on adverse events, length of stay, antibiotic and narcotic use were recorded prospectively from June 2018 to January 2021. Data trends were analyzed throughout the course of the study.
Result(s): During the study period, 542 thyroidectomies were performed by 14 surgeons. The average length of stay was less than 24 hours. Five (0.9%) adverse events were recorded: 1 (0.2%) temporary RLN dysfunction, 3 (0.6%) hematomas, 1 (0.2%) surgical site infection, and 1 (0.2%) temporary hypocalcemia. The average number of narcotics prescribed declined from 18 doses (95%CI: 16.8-18.5) in 2019 to 9 in 2020 (95%CI: 8.5-9.6) (p<0.0001), without an increase in need for refills. No instances of permanent hypocalcemia or permanent RLN injury were identified.
Conclusion(s): By implementing a thyroidectomy quality improvement program, we achieved extremely low rates of adverse events and significantly reduced the use of narcotics without adverse effects. These data can inform practitioners and the public about expected outcomes of thyroid surgery, and establish benchmarks for quality and safety.
Copyright
EMBASE:2014944105
ISSN: 1879-1190
CID: 5024602

Iatrogenic Third Window After Retrosigmoid Approach to a Vestibular Schwannoma Managed with Cochlear Implantation [Case Report]

Deep, Nicholas L; Kay-Rivest, Emily; Roland, J Thomas
OBJECTIVE:To present a case of an iatrogenic inner ear third window after vestibular schwannoma microsurgery. PATIENTS:A 42-year-old male presented 9-months after left-sided retrosigmoid approach for an intracanalicular vestibular schwannoma with hearing-preservation attempt performed elsewhere. Immediately postoperatively, he developed the following disabling and persistent symptoms on the ipsilateral side: autophony, pulsatile tinnitus, high-pitched ringing tinnitus, and hearing his footsteps. He denied vertigo. Otoscopy was normal. Tuning fork (512-Hz) lateralized to the left and Rinne was negative on the left. Audiogram demonstrated a severe mixed hearing loss and 10% aided word-recognition score. High-resolution CT demonstrated violation of the common crus and dehiscence of bone along the medial vestibule suggestive of an iatrogenic inner ear third window. INTERVENTIONS:Labyrinthectomy and concurrent cochlear implantation. MAIN OUTCOME MEASURES:Resolution of third window symptoms, open-set speech recognition, tinnitus suppression. RESULTS:Patient reported immediate resolution of third window symptoms after labyrinthectomy and cochlear implantation. He demonstrates open-set word recognition of 64% at 1-year postoperatively and tinnitus suppression with his cochlear implant on. CONCLUSIONS:Iatrogenic third window symptoms can occur after hearing-preservation vestibular schwannoma microsurgery. Patients with sufficient hearing preservation who are disabled by third window symptoms yet lack sound clarity and useful hearing may be considered for labyrinthectomy and concurrent cochlear implantation. This intervention effectively extinguishes third window symptoms by destroying residual auditory function and simultaneously provides an opportunity to restore useful hearing and suppress tinnitus, thereby enhancing overall quality of life.
PMID: 34267100
ISSN: 1537-4505
CID: 5026512

Outcomes of Salvage Resection and Radiosurgery Following Failed Primary Treatment of Vestibular Schwannomas

Kay-Rivest, Emily; Golfinos, John G; McMenomey, Sean O; Friedmann, David R; Jethanamest, Daniel; Kondziolka, Douglas; Roland, J Thomas
OBJECTIVE:To evaluate outcomes following salvage microsurgery (MS) and salvage stereotactic radiosurgery (SRS) after failure of primary treatment for vestibular schwannomas (VS). STUDY DESIGN/METHODS:Retrospective chart review. SETTING/METHODS:Tertiary referral center. METHODS:Patients with more than 1 intervention for their VS were divided into 4 groups: MS followed by SRS (n = 61), MS followed by MS (n = 9), SRS followed by MS (n = 7), and SRS followed by SRS (n = 7), and outcomes were evaluated. RESULTS:A total of 77 patients were included (84 procedures). In group 1 (MS then SRS), 3% developed a decline in facial function, 3% developed trigeminal sensory loss, and 13% patients had gradual improvement of facial nerve function following SRS. Group 2 (MS then MS) had the highest rates of facial nerve deterioration, although all but 1 patient achieved a House-Brackmann score of II or III. Gross-total resection (GTR) was achieved in 56% of patients. When a different approach was used for salvage resection, GTR occurred more commonly, and facial nerve outcomes were similar. In group 3 (SRS then MS), GTR occurred in 43% of cases, and 2 of 7 patients developed worsened facial function. In group 4 (SRS then SRS), no patient developed facial weakness after reirradiation, and 1 developed a trigeminal nerve deficit. CONCLUSIONS:For MS recurrences/residuals, SRS is the mainstay of treatment and does not preclude facial function recovery. If salvage microsurgery is required, an alternate approach should be considered. For SRS failures, when MS is required, less-than GTR may be preferable, and reirradiation is a potential safe alternative.
PMID: 34488519
ISSN: 1097-6817
CID: 5067092

Phase 0 Clinical Trial of Everolimus in Patients with Vestibular Schwannoma or Meningioma

Karajannis, Matthias A; Mauguen, Audrey; Maloku, Ekrem; Xu, Qingwen; Dunbar, Erin M; Plotkin, Scott R; Yaffee, Anna; Wang, Shiyang; Roland, J Thomas; Sen, Chandranath; Placantonakis, Dimitris G; Golfinos, John G; Allen, Jeffrey C; Vitanza, Nicholas A; Chiriboga, Luis A; Schneider, Robert J; Deng, Jingjing; Neubert, Thomas A; Goldberg, Judith D; Zagzag, David; Giancotti, Filippo G; Blakeley, Jaishri O
Inhibition of mTORC1 signaling has been shown to diminish growth of meningiomas and schwannomas in preclinical studies, and clinical data suggest that everolimus, an orally administered mTORC1 inhibitor, may slow tumor progression in a subset of NF2 patients with vestibular schwannoma (VS). To assess the pharmacokinetics, pharmacodynamics and potential mechanisms of treatment resistance, we performed a pre-surgical (phase 0) clinical trial of everolimus in patients undergoing elective surgery for VS or meningiomas. Eligible patients with meningioma or VS requiring tumor resection enrolled on study received everolimus 10 mg daily for 10 days immediately prior to surgery. Everolimus blood levels were determined immediately prior to and after surgery. Tumor samples were collected intraoperatively. Ten patients completed protocol therapy. Median pre- and post-operative blood levels of everolimus were found to be in a high therapeutic range (17.4 ng/ml and 9.4 ng/ml, respectively). Median tumor tissue drug concentration determined by mass spectrometry was 24.3 pg/mg (range 9.2-169.2). We observed only partial inhibition of phospho-S6 in the treated tumors, indicating incomplete target inhibition compared to control tissues from untreated patients (p=0.025). Everolimus led to incomplete inhibition of mTORC1 and downstream signaling. These data may explain the limited anti-tumor effect of everolimus observed in clinical studies for NF2 patients and will inform the design of future pre-clinical and clinical studies targeting mTORC1 in meningiomas and schwannomas.
PMID: 34224367
ISSN: 1538-8514
CID: 4932142

Hearing loss and volumetric growth rate in untreated vestibular schwannoma

Gurewitz, Jason; Schnurman, Zane; Nakamura, Aya; Navarro, Ralph E; Patel, Dev N; McMenomey, Sean O; Roland, J Thomas; Golfinos, John G; Kondziolka, Douglas
OBJECTIVE:In this study, the authors aimed to clarify the relationship between hearing loss and tumor volumetric growth rates in patients with untreated vestibular schwannoma (VS). METHODS:Records of 128 treatment-naive patients diagnosed with unilateral VS between 2012 and 2018 with serial audiometric assessment and MRI were reviewed. Tumor growth rates were determined from initial and final tumor volumes, with a median follow-up of 24.3 months (IQR 8.5-48.8 months). Hearing changes were based on pure tone averages, speech discrimination scores, and American Academy of Otolaryngology-Head and Neck Surgery hearing class. Primary outcomes were the loss of class A hearing and loss of serviceable hearing, estimated using the Kaplan-Meier method and with associations estimated from Cox proportional hazards models and reported as hazard ratios. RESULTS:Larger initial tumor size was associated with an increased risk of losing class A (HR 1.5 for a 1-cm3 increase; p = 0.047) and serviceable (HR 1.3; p < 0.001) hearing. Additionally, increasing volumetric tumor growth rate was associated with elevated risk of loss of class A hearing (HR 1.2 for increase of 100% per year; p = 0.031) and serviceable hearing (HR 1.2; p = 0.014). Hazard ratios increased linearly with increasing growth rates, without any evident threshold growth rate that resulted in a large, sudden increased risk of hearing loss. CONCLUSIONS:Larger initial tumor size and faster tumor growth rates were associated with an elevated risk of loss of class A and serviceable hearing.
PMID: 34416729
ISSN: 1933-0693
CID: 5092022

Cochlear implantation for single-sided deafness after COVID-19 hospitalization

Asfour, Leena; Kay-Rivest, Emily; Roland, J Thomas
INTRODUCTION/UNASSIGNED:Understanding the clinical manifestations of the coronavirus disease (COVID-19) has become an urgent objective in the research community. Amongst the emerging neurologic complications is sensorineural hearing loss. While several cases of hearing loss amongst COVID-19 patients have been reported, the management of these patients has yet to be discussed and determined. Herein we present cochlear implant outcomes for a patient who suffered from unilateral sensorineural hearing loss after a prolonged hospital course for COVID-19. METHODS/UNASSIGNED:A patient who was hospitalized for COVID-19 for one month and subsequently developed unilateral profound sensorineural hearing loss underwent cochlear implantation for single-sided deafness. His COVID-19 hospital course was reviewed in detail. Speech perception and audiometric assessments were used to evaluate cochlear implant outcomes. RESULTS/UNASSIGNED:After cochlear implantation, the patient demonstrated improved speech perception on the implanted side and decreased tinnitus within 1 month of activation. CONCLUSIONS/UNASSIGNED:Cochlear implantation may be an appropriate intervention for patients who suffer from severe sensorineural hearing loss following infection with COVID-19.
PMID: 34151741
ISSN: 1754-7628
CID: 4965542

Awake cochlear implantation

Deep, Nicholas L.; Connors, Joseph; Roland, J. Thomas
An increasing number of elderly patients are seeking hearing rehabilitation strategies, including cochlear implantation. Elderly patient who are frail or those with significant pre-existing comorbidities have a higher risk of perioperative morbidity after undergoing surgery with general anesthesia. Additionally, there is a growing concern that general anesthesia could increase the risk of dementia or postoperative cognitive decline. In patients who wish to avoid the perceived medical and cognitive risks attributed to general anesthesia or for those who are deemed medically unfit for general anesthesia, surgery under local anesthesia with conscious sedation may be offered. This article details the surgical technique of local anesthesia with conscious sedation and describes the modifications and technical nuances which may be employed for executing a successful surgery.
SCOPUS:85107134108
ISSN: 1043-1810
CID: 4921812

The importance of intraoperative plain radiographs during cochlear implant surgery in patients with normal anatomy

Cohen, Ohad; Sichel, Jean Yves; Shaul, Chanan; Chen, Itay; Roland, J. Thomas; Perez, Ronen
Although malpositioning of the cochlear implant (CI) electrode array is rare in patients with normal anatomy, when occurring it may result in reduced hearing outcome. In addition to intraoperative electrophysiologic tests, imaging is an important modality to assess correct electrode array placement. The purpose of this report was to assess the incidence and describe cases in which intraoperative plain radiographs detected a malpositioned array. Intraoperative anti-Stenver"™s view plain X-rays are conducted routinely in all CI surgeries in our tertiary center before awakening the patient and breaking the sterile field. Data of patients undergoing 399 CI surgeries were retrospectively analyzed. A total of 355 had normal inner ear and temporal bone anatomy. Patients with intra or extracochlear malpositioned electrode arrays demonstrated in the intraoperative X-ray were described. There were four cases of electrode array malposition out of 355 implantations with normal anatomy (1.1%): two tip fold-overs, one extracochlear placement and one partial insertion. All electrodes were reinserted immediately; repeated radiographs were normal and the patients achieved good hearing function. Intraoperative plain anti-Stenver"™s view X-rays are valuable to confirm electrode array location, allowing correction before the conclusion of surgery. These radiographs are cheaper, faster, and emit much less radiation than other imaging options, making them a viable cost-effective tool in patients with normal anatomy.
SCOPUS:85105635650
ISSN: 2076-3417
CID: 4896532