Implantation In Infants Research Articles

Transvenous endocardial pacing with SelectSecure™ 3830 lead in pediatric patients: case series of two infants and a literature review

BackgroundThe SelectSecure™ 3830 lead is an innovative, lumenless, and thin active fixed lead with a nonretractable screw-in tip and a diameter of 4.1 Fr, making it the thinnest pacing lead available. Its high anti-extrusion properties and durability have shown favorable outcomes in cardiac pacing, especially in pediatric patients. The superfine design and easy implantation of the lead have rendered it a preferred choice in children, particularly in cases of congenital heart disease.Case presentationThis case series presents two infant patients who underwent transvenous endocardial pacing using the SelectSecure™ 3830 lead, along with a comprehensive literature review on the topic. The study followed the patients for 5 years and 3 years, respectively, and observed stable pacing parameters, indicating a positive therapeutic outcome and safety.This article discusses the optimal age and body shape for transvenous lead implantation in infants and highlights the advantages and disadvantages of endocardial and epicardial pacing approaches. Although endocardial pacing offers several benefits such as minimal trauma, short hospital stay, and longer battery life, it may not be suitable for intracardiac shunts, and venous occlusion remains a concern. On the other hand, epicardial pacing may be considered for children with challenging endocardial access but comes with higher risk of lead failure and coronary artery compression.This study emphasizes the importance of careful follow-up in pediatric patients with pacing, as lead failure can occur in young patients owing to growth and development, leading to syncope and battery depletion. The article also underscores the significance of selecting the appropriate pacing location to minimize the impact of cardiac function, with right ventricular septal pacing emerging as a preferable option.ConclusionsThe SelectSecure™ 3830 lead presents a promising solution for transvenous endocardial pacing in pediatric patients with high degree atrioventricular block and bradycardia, ensuring safe and effective pacing as they grow and develop.

Percutaneous epicardial pacing in infants using direct visualization: A feasibility animal study.

Pacemaker implantation in infants and small children is limited to epicardial lead placement via open chest surgery. We propose a minimally invasive solution using a novel percutaneous access kit. To evaluate the acute safety and feasibility of a novel percutaneous pericardial access tool kit to implant pacemaker leads on the epicardium under direct visualization. A custom sheath with optical fiber lining the inside wall was built to provide intrathoracic illumination. A Veress needle inside the illumination sheath was inserted through a skin nick just to the left of the xiphoid process and angled toward the thorax. A needle containing a fiberscope within the lumen was inserted through the sheath and used to access the pericardium under direct visualization. A custom dilator and peel-away sheath with pre-tunneled fiberscope was passed over a guidewire into the pericardial space via modified Seldinger technique. A side-biting multipolar pacemaker lead was inserted through the sheath and affixed against the epicardium. Six piglets (weight 3.7-4.0 kg) had successful lead implantation. The pericardial space could be visualized and entered in all animals. Median time from skin nick to sheath access of the pericardium was 9.5 (interquartile range [IQR] 8-11) min. Median total procedure time was 16 (IQR 14-19) min. Median R wave sensing was 5.4 (IQR 4.0-7.3) mV. Median capture threshold was 2.1 (IQR 1.7-2.4) V at 0.4 ms and 1.3 (IQR 1.2-2.0) V at 1.0 ms. There were no complications. Percutaneous epicardial lead implantation under direct visualization was successful in six piglets of neonatal size and weight with clinically acceptable acute pacing parameters.

PE-454609-3 DEVICE-RELATED ADVERSE EVENTS ATTRIBUTABLE TO EPICARDIAL PACING SYSTEMS IN INFANTS: A MULTICENTER RETROSPECTIVE COHORT STUDY

Infants requiring permanent pacemakers (PMs) must receive epicardial leads and abdominal generators due to their small size. Few studies have explored the prevalence and predictors of device-related adverse events (DRAE) in this population. To explore associations between patient and device characteristics with DRAE in infants requiring permanent PM implantation. This multicenter retrospective cohort study included patients who received a permanent epicardial PM at ≤12 months between 1/1/2015- 8/1/2021. The primary outcome was time to DRAE, defined as a composite of: (1) lead fracture or insulation break; (2) lead exit block; (3) coronary compression; or (4) surgical site infection. The secondary outcome was time to death or heart transplant. Time-to-event analysis was performed using a univariate and multivariate Cox proportional hazards regression model. 178 infants underwent PM implantation (109 postoperative heart block, 65 congenital heart block, and 4 symptomatic bradycardia) at a median age and weight of 93.5 days (range 0-365) and 4.5 kg (1.9-9.3). Median cohort follow-up time was 747 days (1-4559). DRAE occurred in 26 (15%) patients at a median 199.5 days (0-2673). Patients with DRAE were younger (median 15.5 days vs 106 days, p=0.002), smaller (3.6 kg vs 4.7 kg, p=0.03), had less frequent congenital heart disease (62% vs 81%, p=0.04), and had higher generator volume-to-weight ratios (2.9 cc/kg vs 2.3 cc/kg, p=-.02) compared to those without DRAE. The relationships of age, weight, and generator volume-to-weight ratio with DRAE were non-linear, with risk inflections observed at ≤90 days, <4.5 kg, and ≥2.5 cc/kg, respectively. Only age ≤90 days at PM implantation (OR 6.99, 95% CI 2.57-19.0, p<0.001) and female sex (OR 0.39, 95% 0.17-0.88, p=0.024) retained significance on multivariate modeling. Death/transplant occurred in 34 (19%) patients at a median 89.5 days (1-809) with only a pacing indication of symptomatic bradycardia (OR 5.37, 95% CI 1.63-17.70, p=0.006) demonstrating significance on multivariate analysis. Congenital heart disease (OR 1.62, 95% CI 0.63-4.19, p=0.32) was not associated with death/transplant. Permanent PM implantation in infants carries substantial risk of device-related morbidity, predominantly driven by patient age at PM implantation and sex. Sex-specific risk for DRAE requires further investigation. All-cause mortality is strikingly high in infants with permanent PMs and is independent of congenital heart disease.

Ten-year refractive and visual outcomes of intraocular lens implantation in infants with congenital cataract.

There is no consensus regarding optimal target refraction after intraocular lens implantation in infants. This study aimed to clarify relationships of initial postoperative refraction with long-term refractive and visual outcomes. This retrospective review included 14 infants (22 eyes) who underwent unilateral or bilateral cataract extraction and primary intraocular lens implantation before the age of 1 year. All infants had ≥10 years of follow-up. All eyes exhibited myopic shift over a mean follow-up period of 15.9 ± 2.8 years. The greatest myopic shift occurred in the first postoperative year (mean=-5.39 ± +3.50 dioptres [D]), but smaller amounts continued beyond the tenth year (mean=-2.64 ± +2.02 D between 10 years postoperatively and last follow-up). Total myopic shift at 10 years ranged from -21.88 to -3.75 D (mean=-11.62 ± +5.14 D). Younger age at operation was correlated with larger myopic shifts at 1 year (P=0.025) and 10 years (P=0.006) postoperatively. Immediate postoperative refraction was a predictor of spherical equivalent refraction at 1 year (P=0.015) but not at 10 years (P=0.116). Immediate postoperative refraction was negatively correlated with final best-corrected visual acuity (BCVA) (P=0.018). Immediate postoperative refraction of ≥+7.00 D was correlated with worse final BCVA (P=0.029). Considerable variation in myopic shift hinders the prediction of long-term refractive outcomes in individual patients. When selecting target refraction in infants, low to moderate hyperopia (<+7.00 D) should be considered to balance the avoidance of high myopia in adulthood with the risk of worse long-term visual acuity related to high postoperative hyperopia.

Simultaneous Bilateral Cochlear Implantation in Very Young Children Improves Adaptability and Social Skills: A Prospective Cohort Study.

To investigate the value of using the Gesell Development Diagnosis Scale (GDDS) to predict developmental outcomes in very young children who undergo simultaneous bilateral cochlear implantation. In this prospective cohort study, a repeated-measures investigation was conducted in a tertiary referral hospital. A total of 62 children receiving simultaneous bilateral cochlear implantations were enrolled from April 2017 to August 2018. They were divided into 2 groups depending on the operative age: "Infants" group (6 to 12 months, N = 38) or "Children" group (12 to 36 months, N = 24). Data on the surgical outcomes, auditory development, speech production, and developmental indicators were collected until 2 years after the initial fitting. The primary outcome measure was the GDDS, a neuropsychological development examination. Secondary outcomes included the following: complication rate, aided pure-tone average, Infant-Toddler Meaningful Auditory Integration Scale, Categories of Auditory Performance-II, Meaningful Use of Speech Scale, Speech Intelligibility Rating, and the LittlEARS Auditory Questionnaire. The mean ages at implantation in infants and children groups were 9.2 ± 1.17 and 16.6 ± 3.60 months, respectively. Significant differences were found in the social skills ( p = 0.001) and adaptability ( p = 0.031) domains of GDDS. The younger the age of bilateral cochlear implants surgery, the higher developmental quotient of language, social skills, and adaptability the child could achieve after 2 years. The complication rates in the infants and children groups were 0% versus 2.1% ( p = 0.57). There was no surgical complication in the infants group. In the children group, 1 case with enlarged vestibular aqueduct and Mondini malformation had a receiver-implant misplacement on the right side (2%, 1/48). In the two groups, auditory performance and speech production had improved similarly. In the infants group, social skills developmental quotient at baseline had a significant positive relationship with Meaningful Use of Speech Scale after 2 years. Simultaneous bilateral cochlear implantation in younger children improves adaptability and social skills. GDDS is a sensitive tool of evaluating short-term effect of bilateral cochlear implants in neuropsychological development and constitutes a reliable predictor of speech production for the very younger pediatric cochlear implant users.

Primary intraocular lens implantation in infants with unilateral congenital cataract operated before 12 weeks of age

The aim of this study was to report visual outcome and safety after cataract surgery with primary intraocular lens implantation before 12 weeks of age. Infants with visually significant unilateral congenital cataract having primary IOL implantation in the capsular bag before 12 weeks of age in 2007-2016 were enrolled for a prospective study examination in 2017. The medical records were also reviewed. In total, 23 patients with a median age at cataract surgery of 32 days (range, 12-75 days) were included. Seventeen (74%) eyes had persistent foetal vasculature (PFV). After a median follow-up of 6.3 years (range, 1.4-10.9 years), the corrected distance visual acuity was 0.8 logMAR (range, 3.0-0.1 logMAR). All, except one eye, required surgery for visual axis opacification (VAO), with a median of two (range 0-5) additional surgical procedures. Four (17%) eyes developed secondary glaucoma. Cataract surgery with primary IOL implantation before 12 weeks of age resulted in a high number of VAO operations, and the visual outcome varied considerably, showing the range in outcome for this challenging patient group. Co-existent PFV in these young patients was common. The incidence of secondary glaucoma was similar to other studies, despite the young age at surgery, high percentage of PFV and number of surgical procedures for VAO.

Intraocular Lenses for Infants With Aphakia

&#x0D; This systematic review examined intraocular lens implantation in patients aged 12 months or younger at the time of surgery compared with patients aged 12 months or younger with aphakia treated with contact lenses or glasses. It also examined intraocular lens implantation in patients aged 12 months or younger at the time of surgery (i.e., infants) compared with patients older than 12 months up to 12 years of age at the time of surgery (i.e., children).&#x0D; In total, 18 studies (3 randomized controlled trials and 15 nonrandomized studies) were identified that answered the clinical questions relevant to this review. No relevant studies were identified to inform the cost-effectiveness questions.&#x0D; Visual outcomes (i.e., visual acuity) did not seem to differ between patients aged 12 months or younger at the time of surgery who received intraocular lens implantation and in patients with aphakia treated with contact lenses or glasses. Parenting stress was higher in parents of infants who received intraocular lens implantation at 3 months after surgery compared with parents of infants who were treated with contact lenses; however, this difference was not maintained at 1 year after surgery.&#x0D; In 1 study that examined intraocular lens implantation at different ages, age did not appear to be a significant prognostic factor in poor visual outcomes (i.e., visual acuity defined as &gt; 0.5 logMAR).&#x0D; Regarding safety, infants who underwent intraocular lens implantation experienced more frequent occurrences of complications, such as visual axis opacification, compared with infants with aphakia treated with contact lenses or glasses; therefore, more reoperations to remove the opacification were required. Many infants with aphakia who did not receive intraocular lens implantation eventually required the surgery when they got older.&#x0D; There were limited statistical comparisons available for safety outcomes for intraocular lens implantation in infants at different ages. Overall, the incidence in adverse events was similar between infants and children, except for the number of additional surgeries. In the identified literature, younger patients received more additional surgeries than older patients.&#x0D; The risk of bias in the included studies was high. There were many methodological concerns, including selection bias, reporting issues, statistical issues, and study designs with high risk of bias, such as retrospective cohort studies.&#x0D; Family input regarding patients’ and caregivers’ experiences included reports of stress related to the use of contact lenses and stress about outcomes of the cataract removal and/or intraocular lens implantation and the effect on the child, and emphasized timely treatment to ensure optimal development of the child.&#x0D;

Long-term outcome of primary intraocular lens implantation in bilateral congenital cataract in infants with a median age of 35 days at surgery: a case series

ObjectiveTo evaluate the long-term visual outcome and safety after bilateral cataract surgery with primary intraocular lens (IOL) implantation in infants with visually significant cataract at birth operated before 12 weeks...

Primary intraocular lens implantation can be applied in infants over 7 months of age and young children with adequate consideration

In recent years, intraocular lenses (IOLs) have been increasingly used in the correction of aphakia after congenital cataract extraction. But IOL implantation in infants and young children, especially under 1 year old, is still controversy. Large-scale, multi-center, randomly controlled clinical observations on this issue have been conducted. The mid-and long-term results have shown that infantile cataract extraction combined with primary IOL implantation can achieve the same or better visual outcome as aphakic contact lens correction. For infants over 7 months of age and young children, primary implantation of IOLs is relatively safe, with a low complication and secondary operation rate. Compared to the way of aphakic contact lens correction, which could be with more inconvenience, high demand of coordination, a higher infection risk, high cost and the need of a secondary IOL implantation surgery, primary implantation of IOLs at over 7 months of age is worth exploring, with appropriate understanding of the surgical indications and adequate surgical techniques. (Chin J Ophthalmol, 2021, 57: 487-491).

Preliminary testing and evaluation of the renata minima stent, an infant stent capable of achieving adult dimensions.

ObjectivesThis study sought to obtain in vivo data on a new stent and delivery system specifically designed for implantation in infants with the ability to be enlarged to adult dimensions.BackgroundThere are no endovascular stents designed for or approved for use in infants, nor is there a stent capable of being implanted at infant vessel diameters and achieving adult size while maintaining structural integrity. The Minima stent was designed to address these needs.MethodsThis study was performed in 6 piglets who underwent implantation of 22 Minima stents into the following locations: aorta (n = 11), branch pulmonary arteries (n = 6), and central veins (n = 5).ResultsSuccessful deployment occurred in 21/22 attempts. Two instances of post‐deployment migration occurred. Stents were re‐expanded at 1, 2, 3 and 5 months after implant. All stents regardless of location could be re‐dilated to the intended diameter to keep pace with somatic growth (implant diameter 6.9 +/− 1.2 mm; final diameter 16.1 mm +/− 1.4 mm). Histopathology at 1 and 5 months demonstrated widely patent vessel lumens with stent apposition to vessel wall, early mild inflammatory response surrounding stent struts, typical vascular damage and healing response to acute dilation and a progressive smooth neointimal growth covering stent struts over time.ConclusionsIn this in vivo study of the Minima stent, there was high implant success, predictable re‐dilatability to adult diameters and favorable histopathology. Further study is warranted.

Cochlear Implantation in Infants: Why and How.

In children with congenital deafness, cochlear implantation (CI) prior to 12 months of age offers the opportunity to foster more typical auditory development during late infancy and early childhood. Recent studies have found a positive association between early implantation and expressive and receptive language outcomes, with some children able to achieve normal language skills by the time of school entry. Universal newborn hearing screening improved early detection and diagnosis of congenital hearing loss, allowing for earlier intervention, including decision-making regarding cochlear implant (CI) candidacy. It can be more challenging to confirm CI candidacy in infants; therefore, a multidisciplinary approach, including objective audiometric testing, is recommended to not only confirm the diagnosis but also to counsel families regarding expectations and long-term management. Surgeons performing CI surgery in young children should consider both the anesthetic risks of surgery in infancy and the ways in which mastoid anatomy may differ between infants and older children or adults. Multiple studies have found CI surgery in infants can be performed safely and effectively. This article reviews current evidence regarding indications for implantation in children younger than 12 months of age and discusses perioperative considerations and surgical technique.

Cochlear Implantation in Infants: Evidence of Safety.

The aim of this study was to investigate surgical, anesthetic, and device-related complications associated with cochlear implantation (CI) in children younger than 1 year of age. This was a multicenter, retrospective chart review of all children with severe-to-profound sensorineural hearing loss who underwent cochlear implantation with a Cochlear Nucleus Implant System before 1 year of age. Endpoints included perioperative course, major and minor surgical, anesthetic and device-related complications, and 30-day readmission rates. One hundred thirty-six infants (242 ears) met criteria. The mean age at implantation was 9.4 months (standard deviation 1.8). Six-month follow-up was reported in all patients. There were no major anesthetic or device-related complications. Adverse events were reported in 34 of implanted ears (14%; 7 major, 27 minor). Sixteen adverse events occurred ≤30 days of surgery, and 18 occurred >30 days of surgery. The 30-day readmission rate was 1.5%. The rate of adverse events did not correlate with preexisting medical comorbidities or duration under anesthesia. There was no significant difference detected in complication rate for patients younger than 9 months of age versus those 9 to 11 months of age. This study demonstrates the safety of CI surgery in infants and supports reducing the indication for cochlear implantation to younger than 1 year of age for children with bilateral, profound sensorineural hearing loss obtaining a Cochlear Nucleus Implant System.

Ventriculo-subgaleal shunts-broadening the horizons: an institutional experience.

Ventriculo-subgaleal shunt is an established treatment of hydrocephalus following germinal matrix haemorrhage in low birth weight neonates. It is also used in treatment of post-infective hydrocephalus in children. We intend to emphasise the impact of its extended use in multiple clinical conditions to reduce the number of permanent shunt implantation in infants. Retrospective review of clinical cases in a single institution from medical records. VSG shunts with low-pressure valve system were useful in variety of hydrocephalus in infants (post-haemorrhagic, post-infective, post-myelomeningocele, post-shunt block, post-traumatic, hydrocephalus associated with brain tumours). A significant number of infants especially those with post-haemorrhagic and post-myelomeningocele hydrocephalus could be made free of permanent shunt placement. Ventriculo-subgaleal shunt is an effective, less risky temporary solution of hydrocephalus in infants and can be used in a variety of hydrocephalus in children and helps in avoiding shunt dependency in some of them.

A retrospective cohort study of adverse event assessment during anesthesia-related procedures for cochlear implant candidacy assessment and cochlear implantation in infants and toddlers.

BackgroundCochlear implantation in children with sensorineural hearing loss is preferably performed at youngest age because early auditory input is essential to prevent neural plasticity decline. In contrast, the rate of anesthetic adverse events is increased during infancy. Therefore, to provide recommendations regarding an optimal pediatric implantation age, these possible anesthetic risks in infants need to be taken into account.AimsThis study aimed at assessing the relation between the age at cochlear implant surgery and anesthetic and surgical adverse events. Secondary aims were to evaluate anesthetic and surgical adverse events in relation to (a) the number of preoperative anesthesia‐related procedures for cochlear implant candidacy assessment and (b) the anesthetic maintenance agent (total intravenous anesthesia versus inhalation anesthesia) during implantation.MethodsWe executed a retrospective cohort study to evaluate cochlear implantation performed in infants and toddlers between January 2008 and July 2015 in a tertiary pediatric center. We compared anesthetic and surgical adverse events between age‐at‐implantation (0‐12 and 12‐24 months of age) groups. Furthermore, we assessed whether anesthetic adverse events occurred during preoperative anesthesia‐related procedures for cochlear implant candidacy assessment.ResultsForty‐six cochlear implantations were performed in 43 patients requiring 42 preoperative anesthesia‐related procedures. Nineteen cochlear implantations (41.3%) were performed during infancy. During implantation, the maintenance agent was either sevoflurane (n = 22) or propofol (n = 24). None of the patients encountered major anesthetic adverse events, whereas minor adverse events occurred during 34 cochlear implantations. Those attributed to surgery occurred following six implantations. Neither the age at implantation nor the anesthetic maintenance agent was significantly related to the occurrence of both types of adverse events.ConclusionsAdverse events occur independent of the age at implantation, the number of anesthetic preoperative procedures, and the type of anesthetic maintenance agent in patients who received a cochlear implant before 24 months of age.

Effect of Age at Primary Intraocular Lens Implantation on Refractive Growth in Young Children.

To evaluate the effect of age at primary intraocular lens (IOL) implantation on rate of refractive growth (RRG3) during childhood. A retrospective chart review was performed for children undergoing primary IOL implantation during cataract surgery. RRG3 was calculated for one eye from each patient using the first postoperative refraction, last refraction that remained stable (< 1.00 diopters [D] change/2 years), and the corresponding ages. RRG3 values for pseudophakic patients operated on from ages 0 to 5 months were compared with values for patients operated on at ages 6 to 23 months and 24 to 72 months. Patients with refractive errors that stabilized were grouped by age at surgery to compare age at refractive plateau. Of 296 eyes identified from 219 patients, 46 eyes met the inclusion criteria. There was a statistically significant difference in RRG3 among age groups. The mean RRG3 value was -19.82 ± 5.23 D for the 0 to 5 months group, -22.32 ± 7.45 D for the 6 to 23 months group (0 to 5 months vs 6 to 23 months, P = .43), and -9.64 ± 11.95 D for the 24 to 72 months group (0 to 5 months vs 24 to 72 months, P = .01). Age at primary IOL implantation affects the RRG3, especially for children 0 to 23 months old at surgery. Surgeons performing primary IOL implantation in infants may want to use age-adjusted assumptions, because faster refractive growth rates can be expected in young children. [J Pediatr Ophthalmol Strabismus. 2020;57(4):264-270.].

Percutaneous epicardial placement of a prototype miniature pacemaker under direct visualization: An infant porcine chronic survival study.

Pacemaker implantation in infants typically consists of surgical epicardial lead placement with an abdominal generator. Here, we describe the chronic performance of our minimally invasive prototype miniature pacemaker implanted under direct visualization in an immature porcine model. Twelve piglets underwent miniature pacemaker implantation. A self-anchoring two-channel access port was inserted into a 1cm incision in the subxiphoid space, and a thoracoscope was inserted into the main channel to visualize the thoracic cavity under insufflation. The pacemaker leadlet was inserted through a sheath via secondary channel and affixed against the epicardium using a helical side-biting electrode. The miniature pacemaker was tucked into the incision, which was sutured closed. Ventricular sensing, leadlet impedance, and capture thresholds were measured biweekly. A limited necropsy was performed after euthanasia. Nine piglets were followed for a median of 78 (IQR 52-82) days and gained 6.6 ± 3.2kg. Three animals were censored from the analysis due to complications unrelated to the procedure. Capture thresholds rose above maximal output after a median of 67 (IQR 40-69) days. At termination, there was a significant decrease in R-wave amplitude (P=.03) and rise in capture thresholds at 0.4ms (P=.01) and 1.0ms pulse widths (P=.02). There was no significant change in leadlet impedance (P=.74). There were no wound infections. There were no infections following minimally invasive implantation of our prototype miniature pacemaker. Improvements to epicardial fixation are necessary to address diminished leadlet efficacy over time.

Neonates and infants requiring life-long cardiac pacing: How reliable are epicardial leads through childhood?

BackgroundIn the literature, data is lacking on mid-term results of epicardial pacemaker implantation in neonates and infants. Our aim was to evaluate the mid-term results of epicardial pacemakers implanted in infants under 1 year of age. Methods and resultsWe conducted a retrospective review of patients who underwent pacemaker implantation between 2000 and 2017. Pacemaker and lead parameters were reviewed at discharge, 2, 4 and more than 5 years after implantation. A total of 71 patients aged 4 ± 3 months and weighing 4 ± 2 kg were included in the study. Indications for pacemaker implantation were: acquired AV-block (n = 44), congenital AV block (n = 22), sick sinus syndrome (n = 4) and AV block type Mobitz II (n = 1). Median follow-up time was 5 years (range: 1 month–17 years). At 5 years of follow-up, atrial lead energy threshold for pacing decreased significantly (0.72 ± 0.71 μJ to 0.45 ± 0.35 μJ; P < 0.001) but was stable for ventricular leads (0.57 μJ [0.05; 39.47] to 0.64 μJ [0.13; 9.45], P = 0.97). Atrial lead impedance increased significantly (569 ± 137 Ω to 603 ± 134 Ω, P < 0.001), whereas ventricular lead impedance decreased (603 ± 202 Ω to 490 ± 150 Ω, P < 0.001) after 5 years. Repeat operations were required for generator change (n = 55), lead exchange (n = 17) and infection (n = 1). At 2, 5 and 10 years, atrial lead survival was 96%, 91% and 76% and ventricular lead survival was 94%, 82% and 75%, respectively (P = 0.45). ConclusionStable pacing thresholds after 5 years indicated that epicardial pacemakers are safe for infants under 1 year of age until at least school enrolment age. However, due to stimulation at higher heart rates in infancy, battery depletion is a frequent occurrence.

Speech development after cochlear implantation in infants with isolated large vestibular aqueduct syndrome

Background: Few studies on speech performance of children after cochlear implantation (CI) described isolated large vestibular aqueduct syndrome (LVAS).Objective: To investigate speech developmental trajectories of infants with LVAS after CI, and to compare with those who have structurally normal inner ears.Materials and methods: 1112 infants with congenital severe to profound hearing loss participated in this study. 150 infants in group A were diagnosed with LVAS, 962 infants in group B with structurally normal inner ear. The speech performance was assessed via the Meaningful Use of Speech Scale (MUSS). The evaluations were performed pre-implant, 1, 3, 6, 9, 12, 24, 36, 48 and 60 months after CI.Results: The mean scores of the MUSS improved over a 5-year period after implantation in both groups A and B. The LVAS group presented similar speech developmental trajectory to the non-LVAS group at each assessment interval, except pre-operation. There were significant differences in mean scores between vocalizing behavior and oral communication skills, clarification skills of infants in both two groups.Conclusions and significance: Speech performance of infants with LVAS developed rapidly after CI and was similar to infants with structurally normal inner ear. For infants with isolated LVAS, CI had a significant effect and should be recommended as a therapeutic option.

Minimally invasive percutaneous epicardial placement of a prototype miniature pacemaker with a leadlet under direct visualization: A feasibility study in an infant porcine model

Pacemaker implantation in infants is limited to epicardial lead placement and an abdominal generator pocket. We propose a minimally invasive solution using a prototype miniature pacemaker with a steroid-eluting leadlet that can affix against the epicardium under thoracoscopy. The purpose of this study was to evaluate the safety and feasibility of acute implantation of a prototype miniature pacemaker in an infant porcine model. A self-anchoring 2-channel access port was inserted into a 1-cm incision left of the subxiphoid space. A rigid thoracoscope with variable viewing angle was inserted through the main channel to visualize the heart under insufflation. An 18-G needle through the second channel accessed the pericardial space, which was secured with a 7-F sheath. The leadlet was affixed against the epicardium using a distal helical side-biting electrode. The sheath, thoracoscope, and port were removed, and the pacemaker was tucked into the incision. Ventricular sensing, lead impedances, and capture thresholds were measured. Twelve piglets (weight 4.8 ± 1.9 kg) had successful device implantation. The median time from incision to leadlet fixation was 21 minutes (interquartile range [IQR] 18-31 minutes). The median lead impedance was 510 Ω (IQR 495-620 Ω). The median R-wave amplitude was 5.7 mV (IQR 4.2-7.0 mV). The median capture threshold was 1.63 V (IQR 1.32-2.97 V) at 0.4 ms pulse width and 1.50 V (IQR 1.16-2.38 V) at 1.0 ms pulse width. There were no complications. Minimally invasive epicardial placement of a prototype miniature pacemaker under thoracoscopy was safe and avoided open chest surgery and creation of an abdominal generator pocket.

O 028 - How do 3D skeletal parameters influence kinetics?

Pacemaker implantation in infants is limited to epicardial lead placement and an abdominal generator pocket. We propose a minimally invasive solution using a prototype miniature pacemaker with a steroid-eluting leadlet that can affix against the epicardium under thoracoscopy.The purpose of this study was to evaluate the safety and feasibility of acute implantation of a prototype miniature pacemaker in an infant porcine model.A self-anchoring 2-channel access port was inserted into a 1-cm incision left of the subxiphoid space. A rigid thoracoscope with variable viewing angle was inserted through the main channel to visualize the heart under insufflation. An 18-G needle through the second channel accessed the pericardial space, which was secured with a 7-F sheath. The leadlet was affixed against the epicardium using a distal helical side-biting electrode. The sheath, thoracoscope, and port were removed, and the pacemaker was tucked into the incision. Ventricular sensing, lead impedances, and capture thresholds were measured.Twelve piglets (weight 4.8 ± 1.9 kg) had successful device implantation. The median time from incision to leadlet fixation was 21 minutes (interquartile range [IQR] 18–31 minutes). The median lead impedance was 510 Ω (IQR 495–620 Ω). The median R-wave amplitude was 5.7 mV (IQR 4.2–7.0 mV). The median capture threshold was 1.63 V (IQR 1.32–2.97 V) at 0.4 ms pulse width and 1.50 V (IQR 1.16–2.38 V) at 1.0 ms pulse width. There were no complications.Minimally invasive epicardial placement of a prototype miniature pacemaker under thoracoscopy was safe and avoided open chest surgery and creation of an abdominal generator pocket.