Effect of bedside ultrasound-guided versus fluoroscopy-guided transvenous cardiac temporary pacing in children with bradyarrhythmia

doi:10.21203/rs.3.rs-4296565/v1

To compare the efficacy and safety of bedside ultrasound-guided and fluoroscopy-guided transvenous cardiac temporary pacing in the treatment of bradyarrhythmia in children. Children treated by temporary intravenous cardiac pacing from January 2016 to June 2023 in Hunan Provincial Children's Hospital were enrolled, and the characteristics and data of the cases were summarized. Patients were divided into bedside ultrasound-guided group (ultrasound group) and fluoroscopy-guided group (fluoroscopy group) according to the implantation guidance methods. The efficacy, safety and incidence of complications in children were compared, and follow-up analysis was carried out. A total of 30 children were enrolled, including 18 males and 12 females, with a median age of 5.5 (2.9, 10.0) years and a median weight of 18.7 (12.7, 32.7) kg. The most common primary diseases were fulminant myocarditis (13/30 cases) and congenital high-grade AVB (10/30 cases). Among them, the proportion of congenital high AVB in the fluoroscopy group was significantly higher than that in the ultrasound group, and the difference was statistically significant (p=0.007). The implantation process was successful in all 30 children. From the time of pacing decision to implantation, the median time of ultrasound group was 56 (30,60) min, and that of fluoroscopy group was 154 (78,180) min, with a statistically significant difference (P<0.001). A total of 5 cases developed complications. There was no statistically significant difference between the two groups (P>0.05). Compared with traditional fluoroscopic temporary pacing, bedside ultrasound-guided temporary pacing technology can effectively shorten the operation time and reduce the occurrence of complications, and has become a better choice for children's emergency and critical care treatment. The right internal jugular vein is preferred for intravenous implantation.

children

temporary cardiac pacing

bradycardia

ultrasound guided

bedside

Temporary transvenous cardiac pacing is a very effective treatment of severe bradyarrhythmia causing hemodynamic instability. In recent years, with the improvement of the reliability of pacing systems and the increase of clinical experience, temporary transvenous pacemakers are increasingly used in the treatment of acute and critical cardiovascular diseases in children, such as fulminant myocarditis, congenital heart block and malignant arrhythmia [1,2]. In the past, the vast majority of temporary pacing in children was implanted under fluoroscopic guidance, which required a long preparation and anesthesia time and was not conducive to the rescue of critical patients [3,4]. How to choose the appropriate guidance method and implantation path in children maybe a serious challenge.

In the adult field, a large number of studies have demonstrated the efficacy and safety of ultrasound-assisted bedside temporary pacing [5-7], but there is still lacking of relevant studies in the pediatric field [3,4,8]. This study aims to evaluate the effectiveness and safety of the two types of temporary pacing by observing and comparing the treatment process and complications of bedside ultrasound-guided and fluoroscopically guided cardiac pacing in children, so as to provide a reference to choose the appropriate temporary pacing method for children.

2.1 Patient selection

Children with bradyarrhythmia admitted to Hunan Provincial Children's Hospital from January 2017 to June 2023 were selected. The indications for temporary pacing implantation are:1. Bradycardia due to various causes, with symptoms of cardiac insufficiency or hemodynamic instability;2. electrocardiogram (ECG) shows sinus node insufficiency, slow-fast syndrome, high-grade atrioventricular block (AVB), or cardiac arrest. Exclusion Criteria:1. Coagulation dysfunction; 2. Infective endocarditis. All selected children were approved by the informed consent of their families and the medical ethics committee of the hospital.

2.2 Clinical data collection

Clinical data were collected, including gender, age, weight, time of admission and discharge, and underlying clinical diseases. Clinical manifestations include onset, basal heart rate at admission, circulatory manifestations during the course of the disease, and onset of Adams-Stokes syndrome. Results of clinical ancillary tests such as electrocardiogram, echocardiography, and myocardial markers. Treatment conditions such as ventilator use and circulatory assistance, drug use, timing of installation and removal of temporary pacemakers, time from pacing decision to successful implantation, guidance methods used, complications related to implantation, and post-implantation follow-up.

2.3 Patient grouping

All children underwent initial cardiac function assessment and ECG in the intensive care unit, and a pediatric cardiologist completed the preoperative evaluation of temporary pacing implantation if indicated. Two pediatric cardiologists (with interventional qualifications) should select cardiac pacing guidance methods according to the child's condition and the doctor's implantation experience. According to the selected implant guidance method, it was divided into bedside ultrasound guidance group (ultrasound group) and fluoroscopy guidance group (fluoroscopy group).

2.4 Temporary pacing placement method

Bedside ultrasound-guided temporary pacing implantation process: At the bedside of the intensive care unit, a pediatric cardiologist or sonographer uses a GE VIVID7 ultrasound machine for puncture positioning and electrode guidance in the heart chambers. The cardiologist selects right jugular vein, subclavian vein, or femoral vein for venous access and proficiency in puncture. Under ultrasound guidance, the electrode is placed across the tricuspid valve and placed at the apex or septum of the right ventricle. See Figure 1 for details

Figure 1. The process of ultrasound-guided temporary pacing implantation. a: Ultrasound-guided jugular vein puncture (red arrow: needle pathway); b: The electrode tip is advanced in the right atrium through superior vena cava; c: The lead pathway to the right ventricular apex is monitored under ultrasound guidance (red arrow: electrode tip). CA: carotid artery; JV: jugular vein; RA: right atrial; RV: right ventricular

Fluoroscopy-guided temporary pacing implantation process: In the cardiac catheterization room, the anesthesiologist evaluates and selects the appropriate anesthesia (intravenous aspiration combined with general anesthesia or local anesthesia). Under DSA, the pediatric cardiologist completes the vascular puncture, and the pacing electrode is placed at the apex or septum of the right ventricle under fluoroscopic guidance.

Connect the pacing electrode and the temporary extracorporeal pulse generator, set the output pacing current of 3~5 mA according to the age and condition of the child, the perception sensitivity is 2~3 mV, the pacing heart rate is (70~110) times/min, and the pacing catheter and sterile dressing are fixed when the ECG monitor shows a normal pacing signal. Postoperatively, a chest X-ray was taken to observe the position of the pacing lead, and a 12-lead electrocardiogram was recorded. If ECG shows non-boggling or intermittent pacing, electrode displacement is considered, and electrode positioning is adjusted under ultrasound or fluoroscopy until the pacing ventricles are stabilized. Use the Medtronic 5348 single-chamber temporary pacemaker or the Livetec Pace T10 temporary pacemaker with the Abbott 5F bipolar temporary pacing electrode catheter.

2.5 Statistical analysis

Continuous variables are expressed as mean ±SD or median (interquartile range) and categorical variables are expressed as frequency (%). Continuous variables were compared using the Mann-Whitney U test. Categorical variables were compared using the Fisher exact probability method. where p < 0.05 represents a statistically significant difference. Statistical analysis was performed using SPSS for Windows version 23.

A total of 30 children were enrolled, including 18 males and 12 females, with a median age of 5.5 (2.9, 10.0) years, a median weight of 18.7 (12.7, 32.7) kg, and the smallest weight was only 1.58 kg. There were 17 cases of bedside ultrasound guided (ultrasound group) and 13 cases of fluoroscopy guided (fluoroscopy group). The general conditions and clinical characteristics of the two groups are shown in Table 1.

There were no statistically significant differences in age, weight, gender and clinical manifestations between the ultrasound group and the fluoroscopy group (P>0.05). The most common primary diseases in children were fulminant myocarditis (13/30 cases) and congenital high-grade AVB (10/30 cases). Among them, the proportion of congenital high AVB in the fluoroscopy group was significantly higher than that in the ultrasound group, and the difference was statistically significant (p=0.007). However, postoperative high-grade AVB (2/30 cases), channelopathy (3/30 cases) and cardiomyopathy (2/30 cases) were all in the ultrasound group, and none of the cases were in the fluoroscopy group, but the difference was not statistically significant due to the small number of cases (P>0.05).

In clinical treatment, 17 children were treated with respiratory support, 2 with extracorporeal membrane oxygenation (ECMO), and 3 died. Among them, the ECMO and death cases were in the ultrasound group. However, there was no statistically significant difference between the two groups (P>0.05). Among the children supported by ECMO, one had channelopathy with malignant arrhythmias, and one had fulminant myocarditis with shock, and then died of multiple organ failure. Among the other two deaths, one was cardiomyopathy with cardiac arrest and died after prolonged hypoxia, and the other was a neonatal with congenital high AVB combined with necrotizing enteritis and died after sepsis.

In the follow-up treatment, 10 cases were treated with permanent pacemakers, 8 cases in the fluoroscopy group and 2 cases in the ultrasound group, and the difference between the two groups was statistically significant (P=0.007). See Table 1 for details

Table 1 The general conditions and clinical characteristics of the two groups of children

	Overall n=30	Fluoroscopy group n=17	Ultrasound group n=13	p
Age(yrs)	5.5 （2.9,10.0）	5.7 (3.0,9.8)	5.6(2.2,10,4)	0.934
Weight (kg)	18.7 （12.7,32.7）	19 (13.7,30)	18.5(10.3,37.5)	0.869
Male sex	18（60%）	9（52.9%）	9/13（69.2%）	0.465
Clinical presentation
Adams-Stokes	14（46.7%）	7（41.1%）	6（46.1%）	0.538
Heart failure	12（40%）	8（47.0%）	4（30.1%）	0.465
Syncope	3（10%）	0	3（23.1%）	0.07
None	1（3.3%）	1（5.9%）	0
Primary disease
Fulminant myocarditis	13（43.3%）	8（47.0%）	5（38.4%）	0.721
Congenital AVB	10（33.3%）	2（11.8%）	8（61.5%）	0.007
AVB after operation	2（6.7%）	2（11.8%）	0	0.492
Channelopathies	3（10%）	3 （17.6%）	0	0.238
Cardiomyopathy	2（6.7%）	2 （11.8%）	0	0.492
Implant access
Jugular vein	9（30%）	6（35.3%）	3（23.1%）	0.691
Femoral vein	14（46.7%）	6（35.3%）	8（61.5%）	0.269
Subclavian vein	7（23.3%）	5（29.4%）	2（15.4%）	0.427
Ventilator support	17（56.7%）	11（64.7%）	6（46.1%）	0.460
ECMO	2（6.7%）	2（11.8%）	0	0.492
Death	3（10%）	3（17.6%）	0	0.238
Permanent pacemaker implant	10（33.3%）	2（11.8%）	8（61.5%）	0.007

AVB: atrioventricular block; ECMO: extracorporeal membrane oxygenation

Continuous variables are presented as medians (interquartile range) and categorical variables as frequencies (%).

Table 2 Comparison of the safety and efficacy of the two methods of implantation

	Overall n=30	Fluoroscopy group n=17	Ultrasound group n=13	p
Procedural success	30	17（100%）	13（100%）
Indication-to-pace time（min）	63（38,132）	56（30,60）	154（78,180）	＜0.001
Pacing threshold(mV)	1.0（1.0,2.0）	1.0（1.0,1.5）	1.0(1.0,2.0）	0.563
Duration of TP（hr）	90（68,128）	90（52,120）	96（81,159）	0.113
Complications	5（16.6%）	1（5.9%）	4（30.8%）	0.138
electrode displacement	3（10%）	1（5.9%）	2（15.4%）	0.565
myocardial perforation	1（3.3%）	0	1（7.7%）	0.433
Infection	1（3.3%）	0	1（7.7%）	0.433

TP: temporary pacing. Continuous variables are presented as medians (interquartile range) and categorical variables as frequencies (%).

The implantation process was successful in all 30 children. From the time of pacing decision to implantation, the median time of ultrasound group was 56 (30,60) min, and that of fluoroscopy group was 154 (78,180) min, with a statistically significant difference (P<0.001). The median pacing threshold was 1.0 (1.0, 2.0) mV, and the median electrode retention time was 90 (68,128) hours, and there was no significant difference between the two groups (P>0.05).

A total of 5 cases developed complications, including 1 electrode displacement in the ultrasound group and 2 electrode displacement, 1 myocardial perforation, and 1 puncture site infection in the fluoroscopy group. The 5-month-old (5.5 kg) patient with centroid perforation had myocardial perforation after electrode displacement and electrode position adjustment under fluoroscopy. After the electrode was removed in time under surgical thoracotomy, no cardiac tamponade occurred. There was no statistically significant difference between the two groups (P>0.05). See Table 2 for details.

Temporary transvenous cardiac pacing is a very effective treatment of severe bradyarrhythmia causing hemodynamic instability. In the past, transfemoral vein route implantation was usually used for temporary pacing in children, which was a simple procedure, a well-established method, and had a low complication rate [3]. However, due to the long preparation to enter the fluoroscopy operation room, it is not conducive to the rescue of critical patients and may increase the dangerous situations [8]. Fluoroscopy-guided venipuncture remains challenging in low-weight children and those with poor vascular condition, which may increase the risk of vascular injury, hemopneumothorax, and cardiac tamponade [9]. So it is very important to choose the appropriate guidance method and implantation path in children to improve the success rate of implantation, shorten the operation time and reduce the occurrence of complications.

This is the first study comparing the standard temporary pacemaker approach (fluoroscopy-guided temporary pacemaker) with ultrasound-guided temporary pacemaker in children. In the adult field, a large number of studies have demonstrated the efficacy and safety of ultrasound-assisted and bedside temporary pacing [4-6]. In an observational study of 203 adults with emergency temporary pacing, the femoral vein was chosen for fluoroscopy-guided temporary pacing, and the right jugular vein was the major access for ultrasound-guided [10]. This is mainly due to the fact that ultrasound-assisted access to the jugular vein can improve the success rate of puncture, reduce the complication of bleeding, and make it easier for entering the right ventricle. In this study, the temporary pacing implantation was successful in both ultrasound group and fluoroscopy group, and there was no statistical difference between the two groups in the pacing threshold and electrode duration time. For the time of pacing decision to implantation, the ultrasound group was significantly shorter than the fluoroscopy group (median time 56 vs 154 min, P<0.001), indicating that bedside ultrasound-guided implantation could reduce the preparation time and operation time, which was conducive to critical care.

The overall complication rate of transvenous temporary pacing was low, with cardiac tamponade (0.6 %), pneumothorax (0.9%), and vascular complications (2.4 %) found in a large retrospective analysis of adults [11]. In our study, the overall complication rate was 16.6% (5/30), and there was no statistically significant difference between the two groups. There was only one case of electrode displacement in the ultrasound group without serious complications, while in the fluoroscopy group, there was one case of myocardial puncture, one case of puncture site infection, and two cases of electrode displacement. The cause of myocardial perforation was considered that the child had an enlarged heart with thin right ventricular wall. Harris et al. [12] suggested that myocardial perforation is a serious complication in children with temporary pacing, and the use of ultrasound can be very helpful in detecting and managing complications in a timely, especially in children with low body weight. Pinneri et al. [13] found that the risk of electrode displacement and cardiac perforation was lower in the right jugular vein implantation under ultrasound guidance than in the fluoroscopic transfemoral vein implantation group, suggesting that ultrasound assistance can reduce the occurrence of complications. Sjaus et al. [14] found that the relationship between the position of the electrode lead and the cardiac structure can be seen in real time using the image of the subxiphoid ultrasound section, and complications such as cardiac tamponade can be detected early. Even during cardiopulmonary resuscitation (CPR), children with acute cardiomyopathy can be implanted with temporary pacing [15].

In this study, congenital high-grade atrioventricular block (AVB) accounted for a higher proportion in the fluoroscopy group than in the ultrasound group, which may be due to the fact that children with congenital high-grade AVB usually have milder symptoms and most subsequent treatments require a permanent pacemaker under fluoroscopy. Acute cases such as channelopathy, cardiomyopathy, or postoperative AVB were all in the ultrasound group, indicating that clinicians have realized the advantages of bedside ultrasound-guided. For children requiring extracorporeal membrane lung support, it is difficult for the patient to move after catheterization, and femoral and jugular vessels are commonly used vascular access, so bedside ultrasound-guided trans-jugular temporary pacing is the best choice for heart rate support.

The puncture site recommended by the Chinese expert consensus of bedside temporary pacing is the right jugular vein, which is easy to learn, has a high success rate, and is easy to enter the right ventricle [5]. The left subclavian vein is often reserved for permanent pacemaker implantation, and the right subclavian vein is an option. For transfemoral venous puncture, it is easy to compress and stop bleeding, but it is not conducive to lower limb movement, and some children need sedation. In this study, different puncture sites were selected in both groups. But due to the small sample size, there was no statistically significant difference in the selection and success rate of puncture at different sites between the two groups. However, in our practical work, it is difficult for infants and young children to puncture through the jugular vein or subclavian vein, while ultrasound guidance can guide deep venous puncture in real time, reduce the occurrence of vascular complications and improve the success rate. The smallest patient with transvenous temporary pacing in this study was a 29-week preterm infant weighing 1.58 kg, who was successfully punctured into the right internal jugular vein under ultrasound guidance and electrodes were successfully inserted, demonstrating that it can be successfully performed in children with low body weight.

Study limitations

This is a single-center, nonrandomized observational study study with a quite small population. Moreover, allowing the physicians the choice of their favorite technique could affect the final results. To limit this selection bias, we recorded and compared all the clinical characteristics that could differ between the two groups. In the future, it is expected that multi-center large-sample controlled studies will provide more data support for the selection of treatment techniques for acute and critical cases related to bradyarrhythmia in children.

For children with bradyarrhythmia and hemodynamic instability, bedside ultrasound-guided temporary pacing technology can effectively shorten the operation time and reduce the occurrence of complications compared with traditional fluoroscopic temporary pacing, and has become a better choice for children's emergency and critical care treatment. The right jugular vein is preferred for intravenous implantation.

Acknowledgement

The authors thank all the subjects for their participation in this study.

Conflict of interest

The authors have no competing interests to declare that are relevant to the content of this article.

Author Contributions Statement

Yefeng Wang and Zhi Chen had full access to all of the data in the study and take responsibility for the integrity of the data and the accuracy of the data analysis, including and especially any adverse effects. Chao Zuo, Xiang Wang, Yunbin Xiao, Yufan Yang, Min Zeng contributed substantially to the study design, data analysis, interpretation, and the writing of the manuscript. All authors read and approved the final manuscript.

Funding

This work was funded by the grants from Hunan Provincial Science and Technology Department Project (No.2024JJ9349), the Research project of Hunan Provincial Health Project (202206012588), and Hunan Innovative Province Construction Special Project (No.2021SK4019)

Ogunbayo GO, Elayi SC, Ha LD, Olorunfemi O, Elbadawi A, Saheed D, Sorrell VL. Outcomes of Heart Block in Myocarditis: A Review of 31,760 Patients. Heart Lung Circ. 2019 Feb;28(2):272-276. doi: 10.1016/j.hlc.2017.12.005. Epub 2017 Dec 24. PMID: 29402690.
Deshpande S, Shenthar J, Khanra D, Isath A, Banavalikar B, Reddy S, Krishnappa D, Khan H, 2 Kella D, Padmanabhan D. Outcomes in congenital and childhood complete atrioventricular block: A meta-analysis. J Cardiovasc Electrophysiol. 2022 Mar;33(3):493-501. doi: 10.1111/jce.15358. Epub 2022 Jan 27. PMID: 35018695.
Li TT, Cheng J. Clinical analysis of temporary pacemaker implantation in 13 children. Transl Pediatr. 2022 Feb;11(2):174-182. doi: 10.21037/tp-21-586. PMID: 35282021; PMCID: PMC8905110.
Tjong FVY, de Ruijter UW, Beurskens NEG, Knops RE. A comprehensive scoping review on transvenous temporary pacing therapy. Neth Heart J. 2019 Oct;27(10):462-473. doi: 10.1007/s12471-019-01307-x. PMID: 31392624; PMCID: PMC6773795.
Emergency Medicine Branch Of Chinese Medical Association, Bedside Temporary Cardiac Pacing Consensus Emergency Expert Group. [Chinese emergency expert consensus on bedside temporary cardiac pacing (2023)]. Zhonghua Wei Zhong Bing Ji Jiu Yi Xue. 2023 Jul;35(7):678-683. Chinese. doi: 10.3760/cma.j.cn121430-20230228-00124. PMID: 37545442.
Blanco P. Temporary transvenous pacing guided by the combined use of ultrasound and intracavitary electrocardiography: a feasible and safe technique. Ultrasound J. 2019 Apr 4;11(1):8. doi: 10.1186/s13089-019-0122-y. PMID: 31359249; PMCID: PMC6638614.
Liu M, Han X. Bedside temporary transvenous cardiac pacemaker placement. Am J Emerg Med. 2020 Apr;38(4):819-822. doi: 10.1016/j.ajem.2019.12.013. Epub 2019 Dec 9. PMID: 31864866.
Sachweh JS, Vazquez-Jimenez JF, Schöndube FA, Daebritz SH, Dörge H, Mühler EG, Messmer BJ. Twenty years experience with pediatric pacing: epicardial and transvenous stimulation. Eur J Cardiothorac Surg. 2000 Apr;17(4):455-61. doi: 10.1016/s1010-7940(00)00364-x. PMID: 10773570.
Fuchigami T, Nishioka M, Akashige T, Shimabukuro A, Nagata N. Pacemaker therapy in low-birth-weight infants. J Card Surg. 2018 Feb;33(2):118-121. doi: 10.1111/jocs.13529. Epub 2018 Feb 6. PMID: 29411428.
Ferri LA, Farina A, Lenatti L, Ruffa F, Tiberti G, Piatti L, Savonitto S. Emergent transvenous cardiac pacing using ultrasound guidance: a prospective study versus the standard fluoroscopy-guided procedure. Eur Heart J Acute Cardiovasc Care. 2016 Apr;5(2):125-9. doi: 10.1177/2048872615572598. Epub 2015 Feb 11. PMID: 25673783.
Metkus TS, Schulman SP, Marine JE, Eid SM. Complications and Outcomes of Temporary Transvenous Pacing: An Analysis of > 360,000 Patients From the National Inpatient Sample. Chest. 2019 Apr;155(4):749-757. doi: 10.1016/j.chest.2018.11.026. Epub 2018 Dec 10. PMID: 30543806.
Harris JP, Nanda NC, Moxley R, Manning JA. Myocardial perforation due to temporary transvenous pacing catheters in pediatric patients. Cathet Cardiovasc Diagn. 1984;10(4):329-33. doi: 10.1002/ccd.1810100404. PMID: 6488305.
Pinneri F, Frea S, Najd K, Panella S, Franco E, Conti V, Corgnati G. Echocardiography-guided versus fluoroscopy-guided temporary pacing in the emergency setting: an observational study. J Cardiovasc Med (Hagerstown). 2013 Mar;14(3):242-6. doi: 10.2459/JCM.0b013e32834eecbf. PMID: 22240748.
13 Sjaus A, Fayad A. The Use of Subcostal Echocardiographic Views to Guide the Insertion of a Right Ventricular Temporary Transvenous Pacemaker-Description of the Technique. J Cardiothorac Vasc Anesth. 2019 Oct;33(10):2797-2803. doi: 10.1053/j.jvca.2019.01.033. Epub 2019 Jan 16. PMID: 30770181.
Greissman A, Silver P, Nimkoff L, Sagy M. Transvenous right ventricular pacing during cardiopulmonary resuscitation of pediatric patients with acute cardiomyopathy. Pediatr Emerg Care. 1995 Feb;11(1):17-9. doi: 10.1097/00006565-199502000-00005. PMID: 7739955.

No competing interests reported.

Effect of bedside ultrasound-guided versus fluoroscopy-guided transvenous cardiac temporary pacing in children with bradyarrhythmia

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Abstract

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1. Introduction

2. Materials And Methods

3. Results

4. Discussion

5. Conclusions

Declarations

References

Additional Declarations

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