Device Extrusion Research Articles

Boston Type II Keratoprosthesis, 7 Years of Experience and Outcomes From a Spanish Tertiary Eye Care Hospital

To report midterm outcomes of Boston Keratoprosthesis type II at a reference center in Spain. Retrospective case series. This observational study included medical records of 9 patients who underwent Boston Keratoprosthesis type II surgery at Cruces University Hospital from May 2016 through May 2023. A total of 9 eyes received this device during the study period. One patient who had undergone a modification of the standard procedure was excluded. Preoperative and postoperative parameters were studied. The main outcomes analyzed were visual acuity, device retention, and complications and their management. The most common indication for implantation was severe Sjögren syndrome (33.3%) followed by graft-versus-host disease (22.2%). The mean follow-up was 3.89 years (±2.08). Visual acuity improved to better than or equal to 20/40 in 8 eyes (88.8%) and 20/25 in 6 eyes (66.6%), while best-corrected visual acuity of 20/20 was achieved in 4 eyes (44.4%). At the last visit, maximum visual acuity was maintained in 4 patients. The most common postoperative complication was retroprosthetic membrane formation (77.7%). New-onset glaucoma was detected in 4 patients (44.4%). Device extrusion occurred in 1 eye and 2 more patients required replacement surgery. All but 1 of the patients are on postoperative treatment with systemic immunosuppressants. The Boston type II Keratoprosthesis is a useful option for visual rehabilitation in end-stage ocular surface diseases. Multidisciplinary management of complications is of vital importance for the maintenance of vision and the device. Immunosuppressive treatment helps control the inflammation that leads to most associated complications.

Complications of cochlear implantation: a decade’s experience

PurposeSurgery for cochlear implantation is becoming increasingly common. It is a precise surgery and carries with it a number of very specific complications. Although uncommon, they can profoundly affect the recipients’ quality of life. We report on our patients’ population and compare with different series.MethodsThis is a retrospective analysis of patients who underwent cochlear implant surgery in our center or who were referred for management of complications between November 2012 and November 2022.ResultsThere were 2126 patients aged 9 months-68 years [mean 3.2 yrs] with 147 adults > 18 yrs. The male: female ratio was nearly 1. We are reporting on late complications excluding device failures. There were 186 complications [8.7%], 124 minor complications [66% of the complications, 5.8% of the total population; and 62 major complications [ 33% of the complications and 2.9% of the total]. The commonest minor complication was surgical site infection [16%] and the commonest major complication was flap necrosis and device extrusion [26%].ConclusionComplications in our series were comparable to other series from different locations. But there seems to be a difference in the frequency of each complication depending on many factors which must be addressed. Standardization of reporting should be also more homogenized.

Cochlear reimplantation outcomes over 20 years: Expertise in reimplantation surgery and auditory-speech rehabilitation

ObjectivesThe aim of this study was to present an institution's experience with cochlear reimplantation (CRI), to assess surgical challenges and post-operative outcomes and to increase the success rate of CRI. Study designRetrospective single-institution study. SettingTertiary medical center. MethodsWe retrospectively evaluated data from 76 reimplantation cases treated in a tertiary center between 2001 and 2022. Clinical features including etiology of hearing loss, type of failure, surgical issues, and auditory speech performance were analyzed. Categorical Auditory Performance (CAP) and Speech Intelligibility Rating (SIR) scores were used to evaluate pre- and post-CRI outcomes. ResultsThe CRI population comprises of 7 patients from our institute,69 referred patients from other centers. Device failure was the most common reason (68/76, 89.5 %) for CRI; in addition, there were 7 medical failures and 1 had both soft device failure. Medical failures included flap rupture and device extrusion, magnet migration, auditory neuropathy, leukoencephalopathy, foreign-body residue and meningitis. In 21/76 patients, the electrode technology was upgraded. The mean time to failure was 0.58–13 years, with a mean of 4.97 years. The mean (± SD) CAP and SIR scores before and after CRI were 5.2 ± 1.2 versus 5.5 ± 1.1 and 3.4 ± 1.1 versus 3.5 ± 1.1, respectively. Performance was poor in six patients with severe cochlear malformation, auditory nerve dysplasia, leukoencephalopathy, and epilepsy. ConclusionCRI surgery is a challenging but relatively safe procedure, and most reimplanted patients experience favorable postoperative outcomes. Medical complications and intracochlear damage are the main causes of poor postoperative results. Therefore, adequate preoperative preparation and atraumatic CRI should be carried out for optimal results.

An Approach to Managing Recurrent Cochlear Implant Wound Infection and Skin Breakdown.

We report the case of a cochlear implant patient who developed multiple infections with device extrusion necessitating explanation and reimplantation twice. An approach using a vancomycin washout followed by a temporalis muscle rotation and scalp rotation flap was utilized to salvage the device.

Safety and efficacy of percutaneous lead extraction of infected cardiac electronic devices: a single-center study

Abstract Funding Acknowledgements None. Background Infections of implanted cardiac electronic devices (CIEDs) are associated with increased morbidity and mortality. Current guidelines recommend either percutaneous or surgical lead removal. Purpose To assess and document the safety and efficacy of percutaneous lead extraction within our Electrophysiology (EP) Lab over the past 2 years. Methods We enrolled consecutive patients with CIED-related infections who underwent percutaneous lead extractions at our EP lab. Results A total of 26 consecutive patients were included in the study, of whom 21 (81%) were males, with a median age of 67 years. Among these patients, 9 (35%) had permanent pacemakers, 11 (42%) had implantable defibrillator systems, and 6 (23%) had biventricular defibrillator systems. Device extrusion was observed in 17 patients (65%), while the remaining 9 (35%) had lead vegetations. Among the 17 patients with device extrusion, 3 (18%) also had lead vegetations, but only 2 (12%) had positive blood cultures. Among the 9 patients without device extrusion, 5 (56%) had vegetations in the leads and tricuspid valve, while 4 (44%) had positive blood cultures. The mean duration from CIED implantation to infection was 81.5 months. Percutaneous lead extraction of CIEDs was successful in 25 patients (96%) using transvenous rotational dilators and endovascular lead extraction tools. In one patient, femoral access with a snare was required for lead retrieval. In another case, where complete lead removal was necessary, the patient developed a massive pulmonary embolism, leading to surgical removal. Additionally, in one patient with a 20-year-old permanent pacemaker, lead extraction was not successful; however, surgical removal was avoided due to the high risk involved. Conclusions The use of transvenous rotational dilators and endovascular lead extraction tools for transvenous removal of CIEDs due to extrusion and/or endocarditis is safe and highly effective, avoiding high-risk cardiac surgical interventions.

Intraoperative Difficulties and Postoperative Complications Associated With Cochlear Implantations: A Study From Erbil City.

Background and objective Cochlear implants are highly effective for the treatment of severe to profound hearing loss. Cochlear implant surgery is a safe surgical procedure; however, due to many modifications over the years, it has been associated with certain minor and major complications. This study aimed to examine the intraoperative difficulties and postoperative complications in patients who received cochlear implants in Erbil City. Methods We conducted a retrospective descriptive study regarding complications of cochlear implants involving patients who received unilateral or bilateral cochlear Implants at the Rizgary Teaching Hospital and aprivate hospitalin Erbil City from January 2013 to July 2022. Their medical records were analyzed, and data on demographics, intraoperative difficulties, and postoperative complications were gathered. Results A total of 160 patients with cochlear implants (87 male, 54.4%; 73 female, 45.6%) were included in the study. The mean age of the patientsat the time of operation was6.76 ± 8.02 years (range: 1-53 years); 150 of these patients were children and 10 were adults (18 years and above). Intraoperative difficulties occurred in five patients (3.1%). The overall rate of complication was 10%, 7.5% of which was minor(the most common being wound infection) and 2.5%major(the most frequent being device extrusion). Conclusions Cochlear implant surgery is a safeprocedure performed to treat profoundly deaf patients. It is associatedwith a low rate of complications, most of which can be successfully managed with conservative measures or minimal intervention.

Challenges and adverse events in pediatric hypoglossal nerve stimulation

IntroductionHypoglossal nerve stimulation was recently FDA approved for use in children with Down Syndrome and persistent obstructive sleep apnea. Although there is a robust experience in hypoglossal nerve stimulation in adults, we observed several challenges that are unique to providing this therapy to a complex pediatric population with a high rate of sensory processing disorders. We sought to review the adverse events and challenges to inform clinicians as hypoglossal nerve stimulation becomes a more accessible option for this complex population. MethodsRetrospective case series of children with Down Syndrome and persistent OSA who underwent hypoglossal nerve stimulation. Inclusion and exclusion criteria included Down Syndrome, age 10–22 years, persistent severe OSA after adenotonsillectomy (AHI>10 with <25 % central or mixed events), inability to tolerate positive airway pressure, and absence of concentric palatal collapse on sleep endoscopy. Patients were identified and their charts were reviewed. Adverse events and their subsequent management were recorded. The major outcome variable was the total number of adverse events. ResultsA total of 53 patients underwent implantation of a hypoglossal nerve stimulator; 35 (66 %) patients were male and the average age at implantation was 15.1 years (standard deviation 3.0y). A total of 30 adverse events were noted, including 17 nonserious and 13 serious. The most common nonserious complications included temporary tongue discomfort, rash at the surgical site, and cellulitis. Serious complications included readmission (for cellulitis, pain, and device extrusion), reoperation (most commonly for battery depletion) and pressure ulcer formation. ConclusionHypoglossal nerve stimulation provides a much-needed therapy for children with DS and persistent OSA after adenotonsillectomy. Although there is a robust experience in providing this treatment to adults, many considerations must be made when adapting this technology to a pediatric population with a high rate of sensory processing disorders.

RETRACTED: Résultats à long terme de la kératoprothèse de Boston de type I au Canada

To evaluate long-term visual outcomes of Boston type I keratoprosthesis (KPro) surgery and identify risk factors for visual failure. Single surgeon retrospective cohort study including 85 eyes of 74 patients who underwent KPro implantation to treat severe ocular surface disease, including limbal stem cell deficiency, postinfectious keratitis, aniridia and chemical burns. Procedures were performed at the Centre hospitalier de l'Université de Montréal from October 2008 to May 2012. All patients with at least 5 years of follow-up were included in the analysis, including eyes with repeated KPro. Main outcome measures were visual acuity (VA), visual failure, defined as a sustained VA worse than the preoperative VA, postoperative complications, and device retention. Mean follow-up was 7.2±1.3 years (±SD). Mean VA was 2.1±0.7 (logarithm of minimal angle resolution) preoperatively and 1.9±1.2 at last follow-up. In total, 2.4% of patients had VA better than 20/200 preoperatively vs. 36.5% at last follow-up. Maintenance of improved postoperative VA was seen in 61.8% of eyes at 7 years. Preoperative factors associated with visual failure were known history of glaucoma (HR=2.7 [1.2 to 5.9], P=0.02) and Stevens-Johnson syndrome (HR=7.3 [2.5 to 21.4], P<0.01). Cumulative 8-year complication rates were 38.8% retroprosthetic membrane formation, 25.9% hypotony, 23.5% new onset glaucoma, 17.6% retinal detachment, 8.2% device extrusion and 5.9% endophthalmitis. The majority (91.8%) of eyes retained the device 8 years after implantation. Nearly two-thirds of patients exhibited improved VA 7 years after KPro implantation. Preoperative risk factors for visual failure were known glaucoma and Stevens-Johnson syndrome.

Penile and testicular prosthesis following gender-affirming phalloplasty and scrotoplasty: a narrative review and technical insights.

Transgender and gender diverse (TGD) individuals may seek gender-affirming phalloplasty with specific functional goals, including erectile function sufficient for penetrative sexual intercourse. Individuals seeking penile prosthesis placement must accept the potential risks to their phallic anatomy. We review current practices at our center and narrative review of literature discussing techniques for penile prosthesis and testicular prosthesis placement after phalloplasty and scrotoplasty, as well as surgical outcomes, and quality of life outcomes where available. Early discussion of a staged approach to phallic construction with a last step of implant placement is important during initial phalloplasty counseling. Pre-operative counseling at our multi-disciplinary center includes: discussion of surgical history, complications, goals and priorities; physical exam to evaluate phallic size and position, scrotal size, and other anatomic findings that may influence prosthesis selection; urinary evaluation, including uroflowmetry with post-void residual, and a cystoscopy with retrograde urethrogram if indicated based on symptoms or urinary studies, and discussion of surgical risks, benefits and alternatives. Although none of the commercially available penile prosthesis devices in the United States are designed for phalloplasty, modern inflatable and malleable prostheses are adapted for use in the post-phalloplasty setting. Due to the lack of native corpora cavernosa, highly variable phallic anatomy, and the need to adapt implants designed for natal penile anatomy, complication rates of prosthesis placement after phalloplasty remain high, with reported ranges of complications from 20% to 80%. Major complications requiring surgical revision are common relative to implant placement in natal penile anatomy, and include: infection requiring explantation, device extrusion, erosion, migration or malposition, inadequate rigidity, poor aesthetic result, pain, decrease or loss of erogenous and/or tactile sensation, device failure, injury to the urethra, and injury to the neurovascular supply of the penis with resultant partial or complete flap loss. This broad range of complication rates represents the variability with which results are reported and reflect a lack of clear reporting guidelines, significant variability in techniques, and need for more standardization. To optimize outcomes, it is important that surgeons have an in-depth understanding of phalloplasty anatomy and are equipped to manage potential complications in the short- and long-term.

Short-term and Long-term Complications of Cervical Disk Arthroplasty.

A narrative review. This review discusses the short and long-term complications associated with cervical disk arthroplasty (CDA). CDA is a safe and effective motion-sparing alternative to fusion for the treatment of cervical disk pathology in patients with cervical radiculopathy or myelopathy. Although CDA offers advantages over fusion within a narrower set of indications, it introduces new technical challenges and potential complications. A systematic search of several large databases, including Cochrane Central, PubMed, ClinicalTrials.gov, and the World Health Organization International Clinical Trials Registry, was conducted from January 2005 to August 2023 to identify published studies and clinical trials evaluating cervical disk replacement complications and outcomes. Short-term complications are primarily related to surgical approach and include dysphagia reported as high as ~70%, laryngeal nerve injury ~0%-1.25%, Horner syndrome ~0.06%, hematoma ~0.01%, gross device extrusion ~0.3%, whereas long-term complications include adjacent segment disease reported at ~3.8%, osteolysis ~44%-64%, heterotopic ossification ~7.3%-69.2%, implant failure ~3.3%-3.7%, and implant wear, which varies depending on design. Approaches for mitigating complications broadly include meticulous dissection, intraoperative techniques, and diligent postoperative follow-up. This review emphasizes the need for a comprehensive understanding and management of complications to enhance the safety, reproducibility, and success of CDA. As CDA continues to evolve, there remains a critical need for ongoing research to delve deeper into evaluating risk for complications and long-term patient outcomes.

Magnetic Resonance Imaging in Patients with Cochlear Implants without Magnet Removal: A Radiology-Administered Protocol to Enhance Operational Efficiency and Improve Workflow.

To describe the development, implementation, and validation of a radiology-administered protocol to obtain magnetic resonance imaging (MRI) in patients with cochlear implants and auditory brainstem implants without magnet removal. Retrospective review and description of novel care pathway. A radiology-administered protocol was designed based on careful input from the radiology safety committee and neurotology. Radiology technologist training modules, consent instructions, patient educational material, clinical audits, and other safeguards were implemented, with samples provided in this report. The primary outcomes measured included instances of magnet displacement during MRI and premature termination of MRI studies secondary to pain. Between June 19, 2018, and October 12, 2021, 301 implanted ears underwent MRI without magnet removal, including 153 devices housing diametric MRI-conditional magnets, and 148 implants with conventional axial (i.e., nondiametric) magnets. Among cases with diametric MRI-conditional magnets, all studies were completed without magnet dislodgement or need to terminate imaging early due to pain. Among cases with conventional axial (nondiametric) magnets, 29 (19.6%) MRI studies were stopped prematurely secondary to pain or discomfort; the overall rate of this event was 9.6% (29 of 301) among the entire study cohort. In addition, 6.1% (9 of 148) experienced confirmed magnet displacement despite headwrap placement; the overall rate among all cases was 3.0% (9 of 301). Eight of these patients received successful external magnet reseating through manual pressure on the external scalp without surgery, and one required surgical replacement of the magnet in the operating room. There were no documented instances of hematoma, infection, device or magnet extrusion, internal device movement (i.e., gross receiver-stimulator migration), or device malfunction in this cohort related to MRI. We present the successful implementation of a radiology-administered protocol designed to streamline care for cochlear implant and auditory brainstem implant recipients who require MRI and ease clinical demands for otolaryngology providers. Examples of resources developed, including a process map, radiology training modules, consent instructions, patient educational materials, clinical audit, and other procedural safety measures are provided so interested groups may consider adapting and implementing related measures according to need.

Cochlear Implant Salvage in Case of Grounding Wire Extrusion.

Cochlear implantation (CI) is a safe and effective procedure for hearing rehabilitation, with few major complications. Device exposure or extrusion is a rare but major complication that often necessitates explantation due to wound dehiscence or infection. The objective of this report is to present a previously undescribed case in which the cochlear implant grounding wire extruded in 16-month-old patient 3 months post-operatively in the absence of trauma or infection. We reviewed the case report and the pertinent literature. A 16-month old male suffered extrusion of his left cochlear implant grounding wire without known etiology 86 days post-operatively after bilateral cochlear implantation. The patient was taken for surgery, and the electrode was reimplanted without complication followed by 48 hours of prophylactic intravenous antibiotics. Nine month follow up revealed the implant functioning appropriately, with no further major complications encountered. We present this unique case to demonstrate that a cochlear implant grounding wire extrusion is not necessarily an indication for explantation in the absence of infection.

Inferiorly Directed Posterior Cranial Vault Distraction for Treatment of Chiari Malformations.

The authors present a case series of patients with Chiari I malformations treated with distraction osteogenesis of the posterior cranial vault, utilizing a vertical distraction vector for appropriate cranial vault expansion while mitigating the risks of scaphocephaly and cerebellar ptosis. Patients with syndromic and nonsyndromic Chiari I malformations treated with vertical-vector distraction osteogenesis of the posterior cranial vault were identified from 2008 to 2014. Demographics, preoperative and postoperative clinical symptoms, and perioperative details were assessed. Long-term esthetic outcomes, complications, and symptomatic improvement were evaluated in conjunction with neurosurgery. Nine patients were identified. Five had known syndromes, 2 likely had unidentified syndromes, and 2 were nonsyndromic. Seven had prior Chiari-related surgeries. Most presented with hydrocephalus, motor symptoms, and developmental delay. Operatively, 2 to 3 internal distraction fixators were applied such that the vector of distraction was along a cephalad-caudad axis. Devices were activated on postoperative day 5 and distracted 1mm per day. Three postoperative complications were found within the first 3 months which included a dislodged distraction arm, a device extrusion, and a local cellulitis. No complications affected the clinical outcome. Radiographic follow-up showed good bone formation, decompression of the posterior fossa, improved cerebrospinal fluid flow, and no cerebellar ptosis. Neurological surveillance showed improvement in intracranial pressure, hydrocephalus, motor symptoms, and behavioral problems. The authors have presented 9 patients with Chiari I malformations treated with distraction osteogenesis, along with a novel technique to safely and effectively expand the posterior fossa while minimizing the risk of cerebellar ptosis. Level II (prognostic/risk studies).

V12-10 IPP CYLINDER EXTRUSION

You have accessJournal of UrologyCME1 May 2022V12-10 IPP CYLINDER EXTRUSION Engy Habashy, and Tobias Kohler Engy HabashyEngy Habashy More articles by this author , and Tobias KohlerTobias Kohler More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000002638.10AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: The inflatable penile prosthesis (IPP) is a widely accepted surgical treatment for refractory ED. It has the highest satisfaction rates of all ED treatment modalities; however, 7-8% of patients will require reoperations. Mechanical failure, infection, erosion, and extrusion are some of the common indications for reoperations. Our video highlights our IPP revision approach that is aimed to lower the risk of future cylinder extrusion/displacement. We also share a rare case of a retained rear tip during device explanation. METHODS: Our video demonstrates our standard technique of obtaining corporal exposure, performing distal corporotomies to explant the cylinders, and utilizing long-acting sutures to prevent future device extrusion. We also demonstrate an encounter with a retained rear tip and our management approach in that scenario. RESULTS: Our video successfully demonstrates our intraoperative techniques and surgical approach during IPP revision procedures. It also highlights our experience with postoperative cylinder extrusion from 2017-2021. CONCLUSIONS: Our surgical approach during IPP revision using distal corporotomies and long-acting absorbable sutures for corporotomy closure aims to reduce the risk of potential cylinder extrusion. That technique was developed based on our own experience with this complication. Source of Funding: N/A © 2022 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 207Issue Supplement 5May 2022Page: e969 Advertisement Copyright & Permissions© 2022 by American Urological Association Education and Research, Inc.MetricsAuthor Information Engy Habashy More articles by this author Tobias Kohler More articles by this author Expand All Advertisement PDF DownloadLoading ...

IPP Cylinder Extrusion. Our Experience and Approach

ABSTRACT Introduction The inflatable penile prosthesis (IPP) is a widely accepted surgical treatment for refractory ED. It has the highest satisfaction rates of all ED treatment modalities; however, 7-8% of patients will require reoperations. Mechanical failure, infection, erosion, and extrusion are some of the common indications for reoperations. Objective Our video highlights our IPP revision approach that is aimed to lower the risk of future cylinder extrusion/displacement. We also share a rare case of a retained rear tip during device explanation. Methods Our video demonstrates our standard technique of obtaining corporal exposure, performing distal corporotomies to explant the cylinders, and utilizing long-acting sutures to prevent future device extrusion. We also demonstrate an encounter with a retained rear tip and our management approach in that scenario. Results Our video successfully demonstrates our intraoperative techniques and surgical approach during IPP revision procedures. It also highlights our experience with postoperative cylinder extrusion from 2017-2021. Conclusions Our surgical approach during IPP revision using distal corporotomies and long-acting absorbable sutures for corporotomy closure aims to reduce the risk of potential cylinder extrusion. The technique was developed based on our own experience with this complication. Disclosure Any of the authors act as a consultant, employee or shareholder of an industry for: Dr. Kohler is a consultant for Coloplast

Clinical Analysis of Techniques and Complications in 414 Consecutive Cochlear Implantations

Aim: To report the frequency of surgical complications following 414 consecutive cochlear implant surgeries (402 children; 12 adults), of whom 323 underwent standard incision and 91 minimal access incision and to analyze the feasibility of using the minimal access ap-proach in all CI candidates. A careful assessment was performed to analyze whether the latter approach is more advantageous than the former in different quality parameters. Methods: Retrospective analysis of patients who underwent cochlear implant surgery from February 2012 to February 2019 by the same surgeon at a single center. Patients: 414 consecutively implanted patients (male: 51.33% female: 49.33%, Right: 68.66% Left: 26.66%, Bilateral: 4.66%).323 underwent a standard incision (Lazy S) and 91 underwent a minimal access incision. The average age of the standard incision group was 4.3years (range 9months-73years); that of the minimal access group 8.6 years (Range 9months-64years). The average incision size in the standard incision group was 7.61 cm and that of the minimum access group was 4.53cm. Results: Of the 414 patients who underwent surgery there were 30 surgery related complications (12 major, 18 minor), 11 device related complications. Major complications (5.3%) included wound infection (3); device extrusion (1); electrode displacement (2); temporary CSF leak (5) (in patients with cochleovestibular dysplasia’s); magnet displacement (1). The minor complications included transient fa-cial paresis (3); vertigo (2); seroma (9); hematoma (1); tinnitus (3). There were 11 device failures, one secondary to trauma the overall complication rate (9.6%) was low in our center when compared against available literature The mean operative time was 76 minutes for standard incision and 79.5minutes for the minimal access approach. A counter sink well for the receiver stimulator array was created and tie down of the device was done in all patients irrespective of the incision, except when a thin implant was used. Clinical Significance: Cochlear implantation is a low-risk procedure when performed by an experienced surgeon following standard protocol. Detailed preoperative workup, study of access and tailoring of the approach to suit each patient is a necessity to prevent com-plications. The minimal access incision causes less morbidity, is cosmetically more acceptable to patients and offers sufficient access to perform a cochlear implantation without compromising on vital steps.

Continuous Arrhythmia Monitoring in Pediatric and Adult Patients With Left Ventricular Noncompaction.

Patients with left ventricular noncompaction (LVNC) are at risk of clinically significant arrhythmias and sudden death. We evaluated whether implantable loop recorders could detect significant arrhythmias that might be missed in these patients during annual Holter monitoring. Selected pediatric and adult patients with LVNC who consented to implantable loop recorder placement were monitored for 3 years (study duration, 10 April 2014-9 December 2019). Fourteen subjects were included (age range, 6.5-36.4 yr; 8 males). Of 13 patients who remained after one device extrusion, one underwent implantable cardioverter-defibrillator placement. Four patients (31%) had significant arrhythmias: atrial tachycardia (n=2), nonsustained ventricular tachycardia (n=1), and atrial fibrillation (n=1). All 4 events were clinically asymptomatic and not associated with left ventricular ejection fraction. In addition, a high frequency of benign arrhythmic patterns was detected. Implantable loop recorders enable continuous, long-term detection of important subclinical arrhythmias in selected patients who have LVNC. These devices may prove to be most valuable in patients who have LVNC and moderate or greater ventricular dysfunction.

Implanted spinal neuromodulation interventions for chronic pain in adults.

Implanted spinal neuromodulation interventions for chronic pain in adults.

Cervicofacial surgery and implantable hearing device extrusion: management of challenging cases

To describe our management of implantable hearing device extrusion in cases of previous cervicofacial surgery. A review was conducted of a retrospectively acquired database of surgical procedures for implantable hearing devices performed at our department between January 2011 and December 2019. Cases of device extrusion and previous cervicofacial surgery are included. Medical and surgical management is discussed. Four cases of implant extrusion following cervicofacial surgery were identified: one involving a Bonebridge system and three involving cochlear implants. In all cases, antibiotic treatment was administered and surgical debridement performed. The same Bonebridge system was implanted in the middle fossa. The three cochlear implants were removed, and new devices were implanted in a more posterior region. Previous cervicofacial surgery is a risk factor for hearing implant extrusion. The middle fossa approach is the best option for the Bonebridge system. Regarding the cochlear implant, it is always suitable to place it in a more posterior area. An inferiorly based fascio-muscular flap may be a good option to reduce the risk of extrusion.

Abstract 15746: Chlorhexidine Irrigation Without Capsulectomy After Device and Lead Extraction in Patients With Cardiac Implantable Device Infection

Introduction: Pocket management after device removal is unclear in patients with cardiac implantable electronic devices (CIEDs) infection. Capsulectomy has been proposed to reduce the risk of reinfection, this procedure is time consuming and requires extensive tissue debridement with a potential higher risk of hematoma formation. Hypothesis: The use of chlorhexidine and saline pocket irrigation without capsulectomy is effective in the management of CIED related infection. Methods: Patients who underwent transvenous lead extraction without capsulectomy for CIED-related infection were included. After complete hardware removal, thorough scrubbing of the generator pocket with 20 cc of 2% chlorhexidine followed by irrigation with 1L of saline was undertaken. The pocket was dried using sterile drapes and the wound was closed with separate intradermal absorbable suture. Implantation of a new CIED device and antibiotic treatment were given according to treating physicians’ discretion. Patients were followed up for 6 weeks after the procedure, and then every 6 months. Results: Between July 1 st , 2013 and May 1 st , 2019, 34 patients (68.1±10.6 years; 13 female) were included. Median follow-up was 745.5 days (IQ range 444.5-1418 days). Lead or device extrusion (41%) was the most frequent indication for extraction. Additionally, 38% of patients had endocarditis. In 75% of cases, bacteria were isolated from blood, pocket or lead tip cultures. Gram positive bacteria were the most frequently found organisms (59% of cases). In total, 19 patients (56%) had a new device implanted after the procedure; mean follow-up for this group of patients was 1251.1±678.8 days. Average time between device extraction and implant of a new device was 26 days, with 11 patients (32%) having device implant in the following week after extraction, including three patients (9%) who underwent dual chamber pacemaker immediately after lead extraction. There were no immediate or 30-day complications associated with chlorhexidine use. During follow-up, no patients presented recurrent infection. Conclusions: The use of chlorhexidine and saline pocket irrigation without capsulectomy offered excellent results with no cases of reinfection and without taking the risk of hematoma formation.