Aveir VR, retrievable leadless pacing in the young.

INTRODUCTION: Successful implantations of the Aveir VR, have been effectively demonstrated in adults; however, there remain limited reports supporting safe and feasible implantation of the Aveir VR in the young population. METHODS: Retrospective, observational study of Aveir VR implantation of young patients (≦21 years old) at UC Davis Medical Center from November 2022 to January 2024 via the internal jugular or femoral vein implantation approaches. Indications for pacing, patient demographics, pacing thresholds and longevity were reported at the time of implantation and last follow-up. RESULTS: A total of 10 patients received the Aveir VR with a median age of years (IQR 12.5-17) and median weight of 50.8 kg (IQR 44.6-60.9) kg. The majority were male (80%). Aveir VR leadless pacemaker occurred via internal jugular venous (90%) or femoral venous (10%) approaches. Indications for placement were intermittent complete heart block (60%) and sinus pauses (40%). Adequate impedance, sensing and thresholds were maintained from implantation to a median follow-up of 9 months. Predicted pacemaker longevity at follow-up median was 23.8 years. There were no complications in any of the 10 patients. CONCLUSION: Aveir VR implantation via the internal jugular and femoral veins is feasible in the young patient population with stable pacing parameters at follow-up.

Resources for the practice of pediatric neuro-oncology in Mexico: a cross-sectional evaluation.

Background: The evaluation of existing resources and services is key to identify gaps and prioritize interventions to expand care capacity for children with central nervous system (CNS) tumors. We sought to evaluate the resources for pediatric neuro-oncology (PNO) in Mexico. Methods: A cross-sectional online survey with 35 questions was designed to assess PNO resources and services, covering aspects including number of patients, infrastructure, human resources, and diagnostic and treatment time intervals. The survey was distributed to the members of the Mexican Association of Pediatric Oncology and Hematology (AMOHP) who belong to the nation's many different health systems. Results: Responses were obtained from 33 institutions, distributed throughout the country and part of the many health systems that exist in Mexico. Twenty-one (64%) institutions had less than 10 new cases of pediatric CNS tumors per year. Although 30 (91%) institutions saw pediatric patients up to the age of 18 years, 2 (6%) had a cutoff of 15 years. Twenty-four (73%) institutions had between 1 and 3 pediatric oncologists providing care for children with CNS tumors. Six (18%) institutions did not have a neurosurgeon, while 19 (57%) institutions had a pediatric neurosurgeon. All centers had a pathology department, but 13 (39%) institutions only had access to basic histopathology. Eleven (33%) institutions reported histopathological diagnoses within one week, but 3 (9%) took more than 4 weeks. Radiotherapy for pediatric CNS tumors was referred to outside centers at 18 (55%) institutions. All centers had access to conventional cytotoxic chemotherapy, but only 6 (18%) had access to targeted therapy. Eighteen (55%) respondents estimated a survival rate of less than 60%. Fifteen (45%) centers attributed the main cause of mortality to non-tumor related factors, including infection and post-surgical complications. Conclusions: This is the first national assessment of the resources available in Mexico for the treatment of CNS tumors. It shows disparities in resource capacity and a lack of the specific and efficient diagnoses that allow timely initiation of treatment. These data will enable the prioritization of collaborative interventions in the future.

Development of Consensus-Based Best Practice Guidelines for the Peri- and Post-operative Care of Pediatric Patients with Spinal Deformity and Programmable Implanted Devices.

STUDY DESIGN: Modified Delphi consensus study. OBJECTIVE: To develop consensus-based best practices for the care of pediatric patients who have implanted programmable devices (IPDs) and require spinal deformity surgery. SUMMARY OF BACKGROUND DATA: Implanted programmable devices (IPDs) are often present in patients with neuromuscular or syndromic scoliosis who require spine surgery. Guidelines for monitoring and interrogating these devices during the peri-operative period are not available. METHODS: A panel was assembled consisting of 25 experts (i.e., spinal deformity surgeons, neurosurgeons, neuro-electrophysiologists, cardiologists, and otolaryngologists). Initial postulates were based on literature review and results from a prior survey. Postulates addressed the following IPDs: vagal nerve stimulators (VNS), programmable ventriculo-peritoneal shunts (VPS), intrathecal baclofen pumps (ITBP), cardiac pacemakers and implantable cardioverter-defibrillators (ICD), deep brain stimulators (DBS), and cochlear implants. Cardiologist and otolaryngologists participants responded only to postulates on cardiac pacemakers or cochlear implants, respectively. Consensus was defined as ≥80% agreement, items that did not reach consensus were revised and included in subsequent rounds. A total of three survey rounds and one virtual meeting were conducted. RESULTS: Consensus was reached on 39 total postulates across six IPD types. Postulates addressed general spine surgery considerations, use of intraoperative monitoring and cautery, use of magnetically-controlled growing rods (MCGRs), and use of an external remote controller to lengthen MCGRs. Across IPD types, consensus for the final postulates ranged from 94.4-100%. Overall, experts agreed that MCGRs can be surgically inserted and lengthened in patients with a variety of IPDs and provided guidance for the use of intraoperative monitoring and cautery, which varied between IPD types. CONCLUSION: Spinal deformity correction surgery often benefits from the use of intraoperative monitoring, monopolar and bipolar cautery, and MCGRs. Final postulates from this study can inform the peri- and post-operative practices of spinal deformity surgeons who treat patients with both scoliosis and IPDs. LEVEL OF EVIDENCE: V- Expert opinion.

Vectorcardiography signs of a failing Fontan: Heart rate, PR interval, RtQRSvm, QRSvm and SPQRS-T angle as noninvasive markers of late Fontan complications and mortality.

BACKGROUND: Limited data exists on interpreting vectorcardiography (VCG) parameters in the Fontan population. OBJECTIVE: The purpose of this study was to demonstrate the associations between ECG/VCG parameters and Fontan failure (FF). METHODS/RESULTS: 107 patients with a Fontan operation after 1990 and without significant ventricular pacing were included. FF and Fontan survival (FS) groups were compared. The average follow-up after Fontan operation was 11.8 years ±7.1 years. 14 patients had FF (13.1%) which was defined as having protein-losing-enteropathy (1.9%), plastic bronchitis (2.8%), Fontan takedown (1.9%), heart transplant (5.6%), NYHA class III-IV (2.8%) or death (0.9%). A 12­lead ECG at last follow up or prior to FF was assessed for heart rate, PR interval, QRS duration, Qtc and left/right sided precordial measures (P-wave, QRS and T-wave vector magnitudes, spatial P-R and QRS-T angles). Transthoracic echocardiogram evaluated atrioventricular valve regurgitation and ventricular dysfunction at FF or last follow up. A cox multivariate regression analysis adjusted for LV dominance, ventricular dysfunction, HR, PR, QTc, Pvm, QRSvm, SPQRST-angle, RtPvm, RtQRSvm and RtTvm. Ventricular dysfunction, increased heart rate and prolonged PR interval were significantly associated to FF at the multivariate analysis. ROC analysis and Kaplan-meier analysis revealed an increased total mortality associated with a heart rate > 93 bpm, PR interval > 155 mv, QRSvm >1.91 mV, RtQRSvm >1.8 mV and SPQRST angle >92.3 mV with p values <0.001 to 0.018. CONCLUSION: We demonstrate the importance of ECG/VCG monitoring in the Fontan population and suggest specific indicators of late complications and mortality.

Influences of a Supplemental Blend of Essential Oils Plus 25-Hydroxy-Vit-D3 and Zilpaterol Hydrochloride (ß2 Agonist) on Growth Performance and Carcass Measures of Feedlot Lambs Finished under Conditions of High Ambient Temperature.

Forty-eight Pelibuey × Katahdin male intact lambs (25.12 ± 3.79 kg LW) were used in a 70-d growing-finishing trial. Dietary treatments consisted of total mixed corn-based diet supplemented with: (1) no feed additives (Control); (2) 150 mg of essential oils blend plus 0.10 mg of 25-hydroxy-Vit-D3/kg diet offered throughout the 70-d experimental period (EOD3); (3) Control diet fed during the first 35 days and zilpaterol hydrochloride (ZH) supplementation at 6 mg/kg diet offered during the final 35 days of the experiment (32 days with ZH with a withdrawal 3-d before harvest), and (4) basal diet supplemented with EOD3 during first 35 days finishing, and EOD3 in combination with ZH (EOD3 + ZH) during the subsequent 32-days with ZH withdrawal 3 days before harvest. The temperature-humidity index during the experiment averaged 80.4 ± 3.2. There were no treatment interactions (p > 0.20) on growth performance and carcass measures. Supplemental EOD3 did not affect (p = 0.43) dry matter intake (DMI), but increased (p < 0.01) carcass adjusted average daily gain (ADG, 9.2%), gain efficiency (GF, 6.7%), and observed vs. expected dietary net energy for maintenance (NEm, 4.8%) and for gain (NEg, 6.4%). Supplemental ZH did not affect dry matter intake (DMI, p = 0.50) but increased (p < 0.01) carcass adjusted ADG (14.5%), GF (13%) and observed vs. expected dietary NEm (9%) and NEg (11.7%). Compared to control lambs, the combination of both additives increased ADG (24.9%), GF (21.2%), and observed vs. expected dietary NEm and NEg (14.2% and 18.9%, respectively). There were no treatment interactions on carcass characteristics, visceral organ mass, or on gene expression of IGF1, IGF2 and mTOR in longissimus muscle (LM). Supplemental EOD3 increased hot carcass weight (HCW; 4.0%, p < 0.01) but did not affect other carcass measures. Supplemental EOD3 decreased (3%, p = 0.03) intestine mass weight (g intestine/kg empty body weight). Supplemental ZH increased HCW (6%, p < 0.01), dressing percentage (1.7%, p = 0.04), and LM area (9.7%, p < 0.01), and decreased kidney-pelvic-fat percentage (16.2%, p < 0.01), fat thickness (14.7%, p = 0.03), and visceral fat. Compared to controls, the combination of EOD3 with ZH increased HCW (10.2%). It is concluded that growth performance responses to supplemental EOD3 and ZH are additive. Both supplements can be fed in combination without detrimental effects on expected benefits when fed separately. In addition, ZH supplementation improves carcass traits.

Incidence and Risk Factors for Medical Device-Related Pressure Injury in Hemodynamically Unstable Intensive Care Unit Patients: A Prospective Cohort Study.

PURPOSE: The purpose of this study was to determine the incidence and identify potential risk factors for medical device-related pressure injury (MDRPI) in critically ill and hemodynamically unstable adults (patients classified class III or IV on the Therapeutic Intervention Scoring System-28; TISS-28). DESIGN: Prospective cohort study. SUBJECTS AND SETTING: The target population was critically ill adults who were using one or more medical devices and categorized as class III or IV on the TISS-28. The study sample comprised 77 participants followed daily until discharge, death, transfer, or lesion development. Data were collected from January to March 2020. The study setting was an intensive care unit with 40 beds in a large hospital in a municipality in the state of Minas Gerais, Brazil. METHODS: Sociodemographic and pertinent clinical data, pressure injury (PI) risk assessed using the Braden Scale for Pressure Sore Risk, and head-to-toe skin inspections were completed. The incidence rate of MDRPIs was calculated, and survival analyses were completed via the Kaplan-Meier method and Cox regression model. RESULTS: Forty-nine of 77 participants developed an MDRPI, reflecting an incidence rate of 63.6%. Collectively, 71 MDRPIs occurred in these 49 participants. Univariate analysis indicated significant associations between MDRPI occurrences and level of consciousness (P = < .001), use of tube holder for ventilation devices (P = .013), nasal cannula (P = .034), nasogastric cannula (P = .034), presence of edema (P = .001), infection (P = .007), higher TISS score (P = .047), and greater number of medical devices (P = .022). Survival analysis indicated that a high or very high-risk score on the Braden Scale for Pressure Sore Risk (P = .043) and edema (P = .030) are risk factors for MDRPI occurrences in this vulnerable population. CONCLUSIONS: The incidence rate of MDRPIs was 63.6%. The categories with the highest high or very high risk scores on the Braden Scale for Risk of Pressure Pain and Edema emerged as risk factors for MDRPI in this critically ill and vulnerable population.

Atrial placement of Aveir-VR leadless pacemaker in a patient with complex cardiac anatomy.

Leadless pacemakers have provided new treatment modalities that can be especially useful in patients with complex cardiac anatomy and contraindications toward other pacemaker approaches. The Aveir™ single-chamber (VR) leadless pacemaker (LP) (Abbott Laboratories, Chicago, IL) is a recently approved device that can be placed in the right ventricle for patients with bradycardia. In this case, we present a novel use for the device through placement in the atrium to control atrial flutter in a patient with a hypoplastic right ventricle.

Aveir retrievable, 38-mm length, leadless pacemaker implantation in a 23-kg pediatric patient with congenital heart disease.

INTRODUCTION: Complications are more prevalent in pediatric patients receiving pacemaker implants. METHODS: We performed a retrospective review of a retrievable, 38 mm leadless pacemaker implantation in a 23-kg pediatric patient. CASE/DISCUSSION: An active 9-year-old, 23 kg male patient with tetralogy of Fallot with intermittent pacing need presented with a fractured lead and pacing need. He underwent implant of a retrievable leadless pacemaker (Abbott Aveir) via internal jugular vein access, without complication, and with echocardiographic guidance. His threshold was stable at 1.25 V @0.4 ms, with stable impedance and sensing at 5-month follow-up. CONCLUSION: Aveir retrievable leadless pacemakers can be implanted safely in a child with tetralogy of Fallot, as small as 23 kilograms.

Different leadless pacemakers working in harmony (Aveir in the atrium/Micra AV2 in the ventricle) in a patient with dextrocardia and double outlet right ventricle after high-risk infected device extraction.

INTRODUCTION: Patients with congenital heart disease are at increased risk for requiring cardiac pacing during their lifetime. METHODS: We present the first described case of using two leadless pacing systems manufactured by separate companies implanted within the same patient to provide atrial and ventricular pacing due to complex congenital anatomy. RESULTS: A 27-year-old male with dextrocardia with double outlet right ventricle, subaortic ventricular septal defect, and pulmonary stenosis status-post pulmonary valve replacement complicated by ventricular pacing dependence and subsequent atrial pacing dependence after atriotomy-based atypical flutter ablation developed recurrent mediastinitis and pocket infection with erosion despite prolonged antibiotic treatment. Due to atrial and ventricular pacing dependence, a comprehensive congenital care team concluded the need for lead extraction and replacement of pacemaker via leadless peacemaking device. Laser-lead extraction and temporary atrial pacemaker placement was performed. Afterward, a transesophageal echocardiogram guided implantation of both a Micra AV 2 (Medtronic) leadless pacemaker in the interventricular septum within the right ventricle and an Aveir (Abbott) leadless pacemaker in the superior base of the right atrial appendage was performed with successful pacing. Although there is no communication between these devices, atrial-mechanical ventricular pacing was reliable with good implant thresholds, impedances and sensing from both devices. CONCLUSION: Our case demonstrates the feasibility of using dual leadless pacing modalities to simultaneously pace someone at complex, prohibitive risk for temporary permanent or permanent pacemaker devices.

Retrievable leadless pacemakers (Aveir VR) may be beneficial in adult patients with congenital heart disease.

INTRODUCTION: Congenital heart disease may present in up to 1.6 % of newborns. Given high burden of pacing need in adult patients with repaired congenital heart disease and availability of different pacing options, more information on outcomes of newer pacemaker types are needed. Retrievable leadless pacemaker implants in adult congenital patients have not been described. METHODS: Retrospective review of three Aveir (Abbott) retrievable leadless pacemaker implants were reviewed at the UC Davis Medical Center. All patients underwent implant via femoral access. RESULTS: All patients had one deployment only, after mapping prior. No complications occurred. Implant thresholds were 0.5 V (V) @0.2msilliseconds (ms) for patients 1 and 2 and 1 V @0.4 ms for patient 3. With impedances between 500 and 1290 Ω. Sensing was 5.5-8 mV (mV). Follow-up occurred up to one year (for two patients) with similar values overall. The predicted longevities of each device were between 22.6 and >25 years. CONCLUSION: Safety and short-mid-term parameters of retrievable leadless pacemaker implantation is reported in three patients with adult congenital heart disease.

Capacidade funcional e qualidade de vida de adultos e idosos com feridas crônicas / Functional capacity and quality of life of adults and elderly people with wounds

Introdução: As feridas crônicas afetam a população em geral e comprometem negativamente a qualidade de vida e geram impactos biopsicossociais. Objetivo: Analisar a associação entre a capacidade funcional e a qualidade de vida de adultos e idosos com feridas crônicas. Métodos: Estudo transversal com 135 acometidas por feridas crônicas cadastradas nos serviços de atenção primária à saúde de um município de Minas Gerais, Brasil. Para a coleta de dados realizada no período de 2017 a 2018, utilizaram-se os instrumentos i) Cardiff Wound Impact Schedule que foi traduzido, adaptado culturalmente e validado para a língua portuguesa do Brasil; ii) Índice de Katz e iii) questionário sociodemográfico com informações sobre o perfil de saúde/doença e características das feridas. Resultados: Houve predomínio de participantes do sexo feminino (59,3%), com idade acima de 60 anos (70,4%) e até 4 anos de estudo (72,6%). No questionário Cardiff Wound Impact Schedule, o domínio com menor pontuação foi o de bem-estar (média 45,6 ± 18,2). Na avaliação da funcionalidade realizada por meio do Índice de Katz, destaca-se que 30 (22,2%) pessoas foram consideradas dependentes para tomar banho e 33 (24,4%) necessitavam de ajuda para se locomover. Houve associação estatisticamente significativa entre as seguintes variáveis independentes do Índice de Katz e do Cardiff Wound Impact Schedule para "vida social" e "banho", "vida social" e "vestir-se", "vida social" e "higiene pessoal", "vida social" e "locomoção", "vida social" e "alimentação", "sintomas físicos e vida diária" e "vestir-se", "bem-estar" e "continência". Conclusão: A incapacidade funcional está associada à diminuição da qualidade de vida de adultos e idosos com feridas crônicas (AU).

Introdução: As feridas crônicas afetam a população em geral e comprometem negativamente a qualidade de vida e geram impactos biopsicossociais. Objetivo: Analisar a associação entre a capacidade funcional e a qualidade de vida de adultos e idosos com feridas crônicas. Métodos: Estudo transversal com 135 acometidas por feridas crôni-cas cadastradas nos serviços de atenção primária à saúde de um município de Minas Gerais, Brasil. Para a coleta de dados realizada no período de 2017 a 2018, utilizaram-se os instrumentos i) Cardiff Wound Impact Schedule que foi traduzido, adaptado culturalmente e validado para a língua portuguesa do Brasil; ii) Índice de Katz e iii) questio-nário sociodemográfico com informações sobre o perfil de saúde/doença e características das feridas. Resultados: Houve predomínio de participantes do sexo feminino (59,3%), com idade acima de 60 anos (70,4%) e até 4 anos de estudo (72,6%). No questionário Cardiff Wound Impact Schedule, o domínio com menor pontuação foi o de bem-estar (média 45,6 ± 18,2). Na avaliação da funcionalidade realizada por meio do Índice de Katz, destaca-se que 30 (22,2%) pessoas foram consideradas dependentes para tomar banho e 33 (24,4%) necessitavam de ajuda para se locomover. Houve associação estatisticamente significativa entre as seguintes variáveis independentes do Índice de Katz e do Cardiff Wound Impact Schedule para "vida social" e "banho", "vida social" e "vestir-se", "vida social" e "higiene pessoal", "vida social" e "locomoção", "vida social" e "alimentação", "sintomas físicos e vida diária" e "vestir-se", "bem-estar" e "continência". Conclusão: A incapacidade funcional está associada à diminuição da qualidade de vida de adultos e idosos com feridas crônicas (AU).

Catheter ablation of atrioventricular nodal reentrant tachycardia, when AVNRT presented as a fetus or infant.

BACKGROUND: Atrioventricular nodal reentrant tachycardia (AVNRT) does not commonly present during infancy. Although relative safety of catheter ablation of AVNRT has been demonstrated in pediatrics, this procedure is rarely indicated in children <15 kg. METHODS: Retrospective review of seven cases of AVNRT that presented in children younger than 1 year of age and required catheter ablation for definitive management. Electrophysiology (EP) study was planned with two or three catheters. Area of ablation determined by voltage mapping, propagation sinus wave collision and slow pathway potential location. Ablation performed with cryothermal energy. No fluoroscopy was used. RESULTS: Presentation ranged from 36 weeks of gestation to 11 months of age. Two presented in fetal life and two in the neonatal period. The median age of ablation was 20 months (range 17-31 months). The median weight at ablation was 11.4 kg (range 8.9-14.9 kg). Median follow-up time was 16 months. All had typical AVNRT. The median tachycardia cycle length was 216 ms. 100% successful rate using cryoablation. No complications. No recurrence of tachycardia during the follow-up period. CONCLUSION: Slow AV nodal pathway cryoablation may be safely performed, with good short and medium-term outcomes in patients under 15 kg.

Loop recorder implantation in patients as young as 3-months of age; the benefit of the sub-scapular approach.

BACKGROUND: Loop recorder implants may have value in pediatric patients; however, size limitations exist due to the risk of erosion. METHODS: Retrospective review of five patients who underwent subscapular loop recorder implantation were reviewed. RESULTS: No complications occurred. Stable R-waves were noted but could be positional but with adequate diagnostics provided. CONCLUSION: Subscapular loop recorder implantation is feasible in patients as young as 3 months of age.

Acute Bowel Ischemia in a Premature Neonate with Miller-Dieker Syndrome and Anomalous Right Coronary Artery From the Pulmonary Artery.

Miller-Dieker syndrome (MDS) is a rare disease characterized by type I lissencephaly, craniofacial dysmorphisms, intellectual disability, seizures, and death in early childhood. We report a case of a premature infant with MDS with an anomalous right coronary artery from the pulmonary artery who developed sudden bowel ischemia. This case prompts the reconsideration of cardiovascular involvement in patients with MDS. In addition, this review highlights key clinical features and reviews the critical manifestations of MDS that persist into childhood. [Pediatr Ann. 2023;52(8):e283-e291.].

First report of an Aveir retrievable leadless pacemaker in a pediatric patient, via internal jugular vein access.

BACKGROUND: The Aveir device allows retrievability and mapping prior to fixation over alternative leadless pacemakers. CASE SUMMARY: We describe the first case of Aveir leadless pacemaker implantation into a 44.5 kg, pediatric patient with symptomatic sinus dysfunction. Access by the right internal jugular vein (RIJ) with 1st attempt implantation into the septal location. DISCUSSION: Placement of the Aveir leadless pacemaker is feasible in a 44.5 kg pediatric patient via a RIJ approach.

Decreased vector magnitudes may help identify events in patients with Long QT syndrome.

INTRODUCTION: All Long QT syndrome (LQTS) patients are at elevated risk for channelopathy-induced delayed myocardial repolarization and consequently potentially life-threatening cardiac events with 90% of initial cardiac events occurring between preteen and 40 years old. Utilizing ECG and derived vectorcardiographic parameters, including T wave Vector Magnitude (TwVM) measurement data, this study attempts to determine whether TwVM from baseline ECGs is effectively predictive of future cardiac events for genotype-positive LQTS patients. METHODS: Verified carriers of established LQTS disease-causing genotypes were selected from University of Minnesota patient encounters between 2010 and 2020 for inclusion in this retrospective study. Baseline and predictive ECG and derived vectorcardiographic parameter evaluation, clinical data, and statistical analysis were compared between patients with and patients without cardiac events. First recorded ECG was at presentation to our hospital and final ECG is defined as ECG just prior to cardiac event (event defined below in Methods) or the most final documented ECG before cut-off year of 2020 for the event-free group. RESULTS: Of 41 participants, 15 experienced cardiac events and 26 did not. While many baseline electrocardiographic parameter measurements did not show significant differences between patient groups, vectorcardiographic parameters at baseline, specifically the QRS vector magnitude (QRSVM) and azimuth of the spatial ventricular gradient, showed significance. Additionally, final vectorcardiographic parameters, particularly the QRSVM, TwVM, and azimuth of the spatial ventricular gradient showed significant differences between patient groups. Final T-wave frontal axis was significantly larger in those without cardiac events. Significant Kaplan-Meier curve separation between patient groups was noted based on a QRSVM of 1.43 mV or lower, with additional consideration to patient age, genotype, and beta blocker use. CONCLUSION: This study shows evidence of ECG and derived vectorcardiographic parameters, including TwVM, being effective in early prediction of cardiac events in genotype-positive LQTS patients.

Transcatheter Leadless Pacing in Children: A PACES Collaborative Study in the Real-World Setting.

BACKGROUND: Transcatheter Leadless Pacemakers (TLP) are a safe and effective option for adults with pacing indications. These devices may be an alternative in pediatric patients and patients with congenital heart disease for whom repeated sternotomies, thoracotomies, or transvenous systems are unfavorable. However, exemption of children from clinical trials has created uncertainty over the indications, efficacy, and safety of TLP in the pediatric population. The objectives of this study are to evaluate clinical indications, procedural characteristics, electrical performance, and outcomes of TLP implantation in children. METHODS: Retrospective data were collected from patients enrolled in the Pediatric and Congenital Electrophysiology Society TLP registry involving 15 centers. Patients ≤21 years of age who underwent Micra (Medtronic Inc, Minneapolis, MN) TLP implantation and had follow-up of ≥1 week were included in the study. RESULTS: The device was successfully implanted in 62 of 63 registry patients (98%) at a mean age of 15±4.1 years and included 20 (32%) patients with congenital heart disease. The mean body weight at TLP implantation was 55±19 kg and included 8 patients ≤8 years of age and ≤30 kg in weight. TLP was implanted by femoral (n=55, 87%) and internal jugular (n=8, 12.6%) venous approaches. During a mean follow-up period of 9.5±5.3 months, there were 10 (16%) complications including one cardiac perforation/pericardial effusion, one nonocclusive femoral venous thrombus, and one retrieval and replacement of TLP due to high thresholds. There were no deaths, TLP infections, or device embolizations. Electrical parameters, including capture thresholds, R wave sensing, and pacing impedances, remained stable. CONCLUSIONS: Initial results from the Pediatric and Congenital Electrophysiology Society TLP registry demonstrated a high level of successful Micra device implants via femoral and internal venous jugular approaches with stable electrical parameters and infrequent major complications. Long-term prospective data are needed to confirm the reproducibility of these initial findings.

Endothelial Progenitor Cells May Be Related to Major Amputation after Angioplasty in Patients with Critical Limb Ischemia.

BACKGROUND: Critical limb ischemia represents an advanced stage of peripheral arterial disease. Angioplasty improves blood flow to the limb; however, some patients progress irreversibly to lower limb amputation. Few studies have explored the predictive potential of biomarkers during postangioplasty outcomes. AIM: To evaluate the behavior of endothelial progenitor cells in patients with critical limb ischemia, in relation to their postangioplasty outcome. METHODS: Twenty patients with critical limb ischemia, candidates for angioplasty, were enrolled. Flow-mediated dilation, as well as endothelial progenitor cells (subpopulations CD45+/CD34+/CD133+/CD184+ and CD45+/CD/34+/KDR[VEGFR-2]+ estimated by flow cytometry) from blood flow close to vascular damage, were evaluated before and after angioplasty. Association with lower limb amputation during a 30-day follow-up was analyzed. RESULTS: Endothelial progenitor cells were related with flow-mediated dilation. A higher number of baseline EPCs CD45+CD34+KDR+, as well as an impaired reactivity of endothelial progenitor cells CD45+CD34+CD133+CD184+ after angioplasty, were observed in cases further undergoing major limb amputation, with a significant discrimination ability and risk (0.75, specificity 0.83 and RR 4.5 p < 0.05). CONCLUSIONS: Endothelial progenitor cells were related with endothelial dysfunction, whereas a higher baseline number of the subpopulation CD45+CD34+KDR+, as well as an impaired reactivity of subpopulation CD45+CD34+CD133+CD184+ after angioplasty, showed a predictive ability for major limb amputation in patients with critical limb ischemia.