Pacemaker Implantation In Infants Research Articles

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.

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.

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.

Long-term outcome of transvenous pacemaker implantation in infants: a retrospective cohort study.

Evaluation of long-term outcome of transvenous pacemaker (PM) implantation in infants. A retrospective analysis of all transvenous PM implantations in infants <10 kg between September 1997 and October 2001 was made. Indications for PM implantation, age at implantation, and determinants of long-term outcome including cardiac function, PM function, and PM (system) complications were noted. Seven patients underwent transvenous VVI(R) PM implantation. Median age at implantation was 3 days (range: 1 day to 14 months), median weight 3.5 kg (range: 2.3-8.7 kg), and median follow-up 14 years (range: 12.3-16.3 years). Pacemaker indications were congenital complete atrioventricular block (n = 4), long QT syndrome with heart block (n = 2), and post-operative complete atrioventricular block with sinus node dysfunction (n = 1). No procedural complications were noted. Today all patients are alive and symptom free with good PM and cardiac function. Two patients underwent PM generator relocation for imminent skin necrosis and skin traction. Two patients suffered from asymptomatic left subclavian vein occlusion and developed thrombosis on the PM electrode. Three patients were converted to an epicardial PM system, due to atrial perforation after upgrading procedure (n = 1), syncope with need for implantable cardioverter defibrillator implantation (n = 1), and systolic dysfunction with development of dilated cardiomyopathy, which normalized under cardiac resynchronization therapy pacing (n = 1). Two patients needed atrioventricular (AV) valve repair for severe insufficiency. Two patients underwent repositioning of dysfunctional PM leads. In five patients, transvenous leads were removed. Indications were elective lead replacement (n = 1), atrial perforation (n = 1), and switch to an epicardial system (n = 3). Transvenous PM implantation in infants (<10 kg) is associated with a high incidence of vascular occlusion, thrombosis, and severe atrioventricular valve regurgitation during long-term follow-up. We advocate an epicardial approach for PM implantation in small children.

Special notice about pacemaker implantation in infants and its follow-up study

Objective Retrospective analysis of pacemaker implantationsites and the follow-up results of its complications and treatment in infants. Methods Infants who implanted pacemakers between Apr. 2000 and Dev. 2011 were included in this study. Endocardial or epicardial pacing was selected based on the patients' condition, age and weight, infants with pathologic sinus syndrome were implanted AAI or VVI pacing model, endocardial pacing was used in patient with congenital complete atrioventricular block, the lead was advanced into right ventricle through subclavian or internal jugular vein, infants with Ⅲ-AVB were often advised to implant epicardial pacing model postoperatively. Antibiotics were used for about 5 days after operation, and then babies were discharged without any complication. In such patients, electrocardiogram, X-ray and echocardiogram examination, and programmed control of pacemaker should be noticed and follow-up study should be conducted. Results Permanent pacemakers were implanted into 46 infants, 29 boys and 17 girls, the average age was (1.57±0.89) years, the average weight was (10.93±3.34) kg, 17 cases with endocardial pacing model and 29 cases with epicardial pacing, 45 cases with single chamber pacing and only 1 case with dual chamber pacing, 2 infants were combined with ASD and 2 with PDA, all of them were closed the defects firstly and then implanted pacemaker. Thirty-six patients were included in the follow-up study, the average follow-up time 4.86 years. New pacemakers were implanted because of battery exhaustion in 13 infants and 7 leads were changed because of lead shifting; the lead was extracted from a baby with D-trans position of great arteries(D-TGA)/VSD after the recovery from atrioventricular conduction 21 days postoperatively. Superficial wound infections, and then wound dehiscence, presented in two babies after one or three months postoperatively; heart failure was found in one patient by 8-year-follow-ups ; endocardial pacing with DDD model replaced epicardial pacing in 3 patients; and pacing model VVI was replaced by pacing DDD in 3 cases. Conclusions The implantation of pacemaker in infant was safe, effective, with rare complications, the implantation of endocardial or epicardial pacing depends on infants' condition, and wound infection or unstable pacing caused by lead shifting or battery exhaustion should be closely watched. Key words: Infants; Permanent pacemaker; Follow-up; Complication

Single-centre experience on endocardial and epicardial pacemaker system function in neonates and infants

Endocardial (ENDO) or epicardial (EPI) pacing systems are implanted in infants but it remains unclear which system should be preferred. We evaluated the results of children <or=1 year who underwent pacemaker (PM) implantation at our centre with a retrospective analysis. Between 1992 and 2004, 56 patients, 37 of whom had other congenital heart defects (CHDs), received a PM at 4.4 +/- 3.8 months of age for atrioventricular block (n = 52) and sinus node dysfunction. Rate-responsive ventricular demand pacing (VVIR) PMs were implanted in 25 patients (19 ENDO), dual-chamber demand pacing (DDD) in 29, and rate-responsive atrial demand pacing (AAIR) in 2 (all EPI). Follow-up (FU) was 4.5 +/- 3.5 (range 0.3-13) years: 15 pacing system failures occurred among the 56 patients (26%) after 4.5 +/- 3.2 years, with a significantly reduced success rate for EPI (21-fold increase of the risk of failure) and complex CHD. Also in patients without surgery for CHD, EPI showed a worse outcome. Among the 91 leads implanted, failures occurred more significantly in EPI (18% of atrial, 24% of ventricular leads) than in ENDO (5% of ventricular leads). No venous occlusion was found at FU. Single-lead, VVIR ENDO pacing had higher efficiency and safety than EPI, and it might be the best choice for PM implantation in infants. However, because of small patient numbers and lack of longer FU, these findings should be treated with caution.

Pacemaker Implantation in Infants and Children

Pacemaker Implantation in Infants and Children

A New Technique for Permanent Pacemaker Implantation in Infants and Children

Permanent pacemaker implantation in the infant or young child presents the surgeon with many technical problems unique to this population. A new technique of implantation is described that was used successfully in 6 pediatric patients. The technique is simple to perform and gives very satisfactory results.

Pacemaker Implantation in Infants and Children: A Simplified Approach

A technique for epicardial pacemaker implantation is described. A single incision is utilized through which the electrode and power pack are implanted. Twelve infants and children were operated on in the last four years using this procedure. The marked improvement in cosmetic appearance and the relative ease in module replacement are major advantages of this method.

Intermuscular Abdominal Implantation of Permanent Pacemakers in Infants and Children

Pacemaker implantation in infants and young children presents technical problems because of the relatively large size of the units. Various implantation sites have been employed to avoid the problems of unsightliness, migration, skin necrosis with infection, and patient discomfort. We are presenting a new technique which obviates these difficulties. The pacemaker generator is located in a space developed between the muscles and fascia of the abdominal wall. This site will accept even the largest of demand pacemakers with cosmetically acceptable results.

Permanent pacemaker implantation in infants, children, and adolescents. Long-term follow-up.

Twenty-four patients in the pediatric age range who underwent implantation of a cardiac pacemaker for treatment of complete atrioventricular (A-V) block were followed for an average of five years (range 1-12 years). The etiology of the A-V block was surgical in 13 cases, congenital in nine, and acquired in two. Twenty patients had symptoms of cerebrovascular insufficiency and four had congestive heart failure. To date, 18 of the 24 patients studied are alive and well. Death occurred in six patients, five of whom had complex congenital heart defects, and one of whom had Refsum's disease. Death probably was caused by complete heart block despite pacemaker treatment in four patients, and congestive heart failure in two. In 18 of the 24 children with disabling complete A-V block, pacemaker therapy provided relief of symptoms and prolonged life.