Abstract
Objective
To investigate the safety and effectiveness of implanting temporary pacemakers using ultrasound‐guidance at the bedside for rescuing patients in case of cardiac emergencies.
Methods
We enrolled 194 patients with cardiac emergencies requiring temporary pacemakers in this study, and randomly assigned them to either a bedside ultrasound‐guided installation group or an electrocardiogram‐guided installation group. There were 105 cases in the bedside ultrasound‐guided installation group, aged approximately 66.3 ± 10.2 years, and 89 cases in the electrocardiogram‐guided installation group, aged approximately 65.8 ± 9.5 years old, and disease composition was similar between the two groups. We then compared the duration of the procedure, success rates, and occurrence of adverse events between the two groups.
Results
The two groups showed similar clinical characteristics. The success rates of venipuncture and temporary pacemaker electrode placement were both 100% in the bedside ultrasound‐guided installation group, compared to 87.8% and 96.7% respectively, in the electrocardiogram‐guided installation group, with a statistically significant difference between the two groups. The duration of puncture was significantly shorter in the bedside ultrasound‐guided installation group than in the electrocardiogram‐guided installation group, with statistically significant differences. Moreover, no adverse events such as hematoma, pneumothorax and electrode dislodgement occurred in the bedside ultrasound‐guided installation group, while 13 cases in the electrocardiogram‐guided installation group experienced adverse events, and the difference was statistically significant.
Conclusions
The bedside installation of temporary pacemakers using ultrasound guidance is a simple, safe, effective, and cost‐efficient procedure that boasts a high success rate, does not involve radiation, and enables accurate placement of the electrode catheter.
Keywords: cardiac emergencies, echocardiogram, rescue, temporary pacemaker, ultrasound guidance
Comparative analysis of the installation time, success rate, and complications of 105 temporary pacemakers guided by ultrasound and 89 temporary pacemakers guided by electrocardiogram.
1. INTRODUCTION
Cardiac emergencies, including severe cardiac arrhythmias, cardiac arrests and sick sinus syndrome combined with Adams‐Stokes syndrome can pose a significant risk to the lives of patients. Rapid and effective implantation of a temporary pacemaker can save valuable time in the treatment of patients with such cardiac emergencies. Temporary pacing electrodes are typically implanted using electrocardiogram‐guided blind deep venous puncture combined with X‐ray (Zhang et al., 2003), a method that can be challenging to operate and may result in adverse events. Consequently, it is challenging to apply this method widely in clinical practice. Doppler ultrasound has become an increasingly popular method of peripheral vascular examination thanks to advances in ultrasound examination technology; it is also used in many different kinds of peripheral vascular interventions. It is common practice to perform diagnostic and therapeutic central venous catheterizations through peripheral veins, with the subclavian vein being the preferred access point. In this study, we aimed to analyze the safety, success rate and adverse events associated with ultrasound‐guided temporary pacemaker implantation at the bedside and compared it to conventional electrocardiogram‐guided temporary pacemaker implantation as a control to discuss its potential clinical value.
2. MATERIALS AND METHODS
2.1. General information
In this study, we selected 194 patients with acute arrhythmias who visited the Emergency Department of the First Affiliated Hospital of Fujian Medical University, from January 2019 to September 2022. These patients were randomly classified into two groups; the bedside ultrasound‐guided temporary pacemaker installation group (the ultrasound group) and the electrocardiogram‐guided temporary pacemaker installation group (the electrocardiogram group).
The inclusion criteria of patients were as follows: (1) patients with acute myocardial infarction, acute myocarditis, drug poisoning, electrolyte disturbances, cardiac trauma, or post‐surgery atrioventricular block; (2) patients with bradycardia combined with poor circulation; (3) patients with slow ventricular escape or symptomatic second‐ or third‐degree atrioventricular block; (4) patients with sick sinus syndrome combined with Adams‐Stokes syndrome; (5) patients with cardiac arrest; (6) patients with emergency and transitional pacing before placement of a permanent pacemaker or during replacement of a permanent pacemaker; (7) patients with a potential risk of arrhythmia who would need to receive surgery as a protective measure.
The exclusion criteria for patient selection were as follows: (1) patients with local or systemic infectious diseases combined with suspected or existing contraindications to intubation; (2) patients who could not tolerate intubation; (3) patients with a history of trauma at the intubation site, local radiation therapy, vascular surgery, or venous thrombosis; (4) patients with obesity or poor temporal insonation windows, such as thoracic deformity; and (5) patients with severe hypothermia, cardiac rupture, acute pericardial tamponade, and other patients with a severe disease requiring immediate treatment.
2.2. Instruments
For this study, we utilized the American MEDTRONIC5348 on‐demand external pacemaker along with a matching system of puncture needles, guidewires, and sheaths. Additionally, we used the Mindray color Doppler ultrasound instrument.
2.3. Puncture procedures
To conduct the puncture in the ultrasound group, the preferred approach was from the right subclavian vein approach (Wu et al., 1999) with the following procedures: First, the patients were positioned in a supine posture with the head tilted backward and to the left and instructed to relax their neck muscles. Next, routine two‐dimensional and color Doppler scans were performed on the subclavian arteries and veins, as well as the brachiocephalic veins. This was done to observe the location and internal diameter of the subclavian veins, changes in the diameter with respiratory movements, the structure of venous valves, and the presence of any abnormal echo within the vessels. Additionally, routine echocardiography was performed to observe the size of the heart, ventricular wall motion, valve opening and closing, papillary muscle position, and large vessel connections. After it was confirmed that there were no contraindications to performing a puncture, the specific location and angle of puncture were determined. After routine disinfection and local anesthesia, the needle was inserted along the diameter of the vein under ultrasound guidance and punctured into the lumen of the vein. The guidewire and catheter were then inserted, and the pacing electrodes were carefully inserted along the catheter. Once the pacing electrode smoothly entered the brachiocephalic vein, the ultrasound probe was placed in the apical part of the heart to guide the pacing electrode into the right heart. During tricuspid valve opening, the electrodes were inserted into the right ventricle and eventually anchored to the right ventricular papillary muscle. Routine electrocardiography was performed to ensure favorable sensing and pacing performance, which indicated that the electrode tip had reached the ideal site and was in moderate contact with the endocardium. After the electrodes were fixed, the operation was completed. If the performance was not ideal during the subclavian vein puncture site selection, the axillary and jugular veins were selected as alternatives (Figure 1).
FIGURE 1.
The puncture procedures of ultrasound‐guided pacemaker implantation in assisted venipuncture and electrode positioning on the papillary muscle. (a) Catheter entry into the subclavian vein guided by vascular ultrasound. (b) Pacemaker electrode guided by echocardiography enters the right ventricle from the right atrium. (c, d) Echocardiography‐guided pacemaker electrode anchoring at the right ventricular papillary muscle level.
The puncture in the electrocardiogram group was performed using the preferred right subclavian vein approach. The patients were placed in a supine position with the head tilted to the left and tilted backward and were instructed to relax the neck muscles. After routine disinfection and local anesthesia, the subclavian vein was punctured. The puncture was confirmed by the return of dark‐red venous blood into the subclavian vein. The guidewire and catheter were then inserted, and the pacing electrodes were inserted along the catheter into the right ventricle. Subsequently, pacing was initiated at a frequency of 15 to 20 beats above the basal heart rate, with a voltage of 4 to 6 V sensing of 2 to 4 mV. After a relatively stable ventricular pacing heart rate emerged, a pacing threshold of around 1.0 mV was determined. A bedside limb‐lead electrocardiogram was then used to confirm the position of the electrodes in the right ventricle. If the main wave of QRS in leads II, III, and aVF was upward, it indicated that the electrode was located in the right ventricular outflow tract and required adjustment. Conversely, if the main wave of QRS in leads III and AVF was downward, the electrode was located in the apical part of the right ventricle. When the electrocardiogram showed a pacing signal with favorable sensing and pacing performance, it suggested that the electrode tip had reached the ideal site and was making moderate contact with the endocardium. The electrodes were then secured, and the procedure was completed. In cases where the subclavian vein puncture site did not yield ideal performance, the axillary and jugular veins were considered as secondary options.
2.4. Post‐surgical follow‐up
The patients were monitored for perioperative adverse events, including pneumothorax, hemopneumothorax, arterial mis‐puncture, local hematoma at the puncture site, and thrombosis in the deep vein lumen and around the electrodes. Furthermore, cardiac echocardiography and deep vein ultrasound were conducted at the puncture site on postoperative days 1, 2, 7, and 14 to assess the heart size, ventricular wall motion, systolic and diastolic functions, pacing electrode displacement or dislodgement, and thrombus formation in the deep vein lumen or around the electrodes.
2.5. Statistics analysis
The data processing was carried out using SPSS18.0 analysis software, and the measurement data are presented as mean ± standard deviation (x ± s). The t‐test was used to compare the two groups, while the count data are expressed as rates or percentages and analyzed with the chi‐squared test. Statistical significance was determined at p < .05.
3. RESULTS
3.1. Comparisons of general information
The ultrasound group comprised of 105 cases (78 males and 27 females) with an average age of 66.3 ± 10.2 years, while the electrocardiogram group had 89 cases (69 males and 20 females) with an average age of about 65.8 ± 9.5 years (Table 1).
TABLE 1.
General information of patients in both groups.
| Groups | Positive sinus bradycardia and atropine test | Atrioventricular block | Bundle branch block | Sick sinus syndrome | Respiratory and cardiac arrest | Total cases | χ2 | p |
|---|---|---|---|---|---|---|---|---|
| Ultrasound group | 83 | 15 | 7 | 1 | 0 | 105 | 0.276 | .599 |
| Electrocardiogram group | 84 | 1 | 1 | 2 | 2 | 89 |
3.2. Success and adverse event rates of central venipuncture
In the ultrasound group, all 105 patients were successfully punctured, resulting in a 100% success rate. On the other hand, in the electrocardiogram group, out of the 89 cases, 79 patients were successfully punctured, with a success rate of 87.8%. The difference in the success rate of central venipuncture was statistically significant between the two groups (p < .05). There were no reported adverse events in the ultrasound group. However, in the electrocardiogram group, six patients developed hematoma at the puncture site, while two patients suffered from arterial mis‐puncture, and two others suffered from pneumothorax. There was no statistically significant difference in the central venipuncture adverse event rates between the two groups (p < .05; Table 2).
TABLE 2.
Comparison of the success rate of central venipuncture and the complication rate of central venipuncture between the two groups.
| Groups | Cases | Success rate of central venipuncture | Complication rate of central venipuncture | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Number of successful cases | Number of failure cases | Success rate (%) | χ2 | p | Hematoma at the puncture site | Arterial mis‐Puncture | Pneumothorax | Complication rate (%) | χ2 | p | ||
| Ultrasound group | 105 | 105 | 0 | 100 | 16.439 | .000 | 0 | 0 | 0 | 0 | 13.758 | .000 |
| Electrocardiogram group | 89 | 76 | 13 | 85.4 | 6 | 2 | 3 | 12.36 | ||||
3.3. Success and adverse event rates of temporary pacemaker electrode placement
In the ultrasound group, all cases demonstrated smooth guidewire passage, accurate anchoring of electrodes, and favorable pacing performance, achieving a success rate of 100%. On the other hand, the electrocardiogram group encountered two cases of failed guidewire passage and one case of inadvertent entry into the coronary sinus and had a success rate of 96.7%. There was a statistically significant difference in the success rate of temporary pacemaker electrode placement between the two groups (p < .05). No adverse events were reported in the ultrasound group. In contrast, the electrocardiogram group experienced one case of electrode dislodgement on the first post‐surgical day, one case of electrode dislodgement on the second post‐surgical day, and three instances of poor pacemaker driving. There was a statistically significant difference in the adverse event rates of temporary pacemaker electrode insertion between the two groups (p < .05; Table 3).
TABLE 3.
Comparison of success rate of temporary pacemaker electrode placement between the two groups.
| Groups | Cases | Success rate of temporary pacemaker electrode placement | Complication rate after temporary pacemaker electrode placement | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Failed guidewire passage | Inadvertent entry into the coronary sinus | Number of failure cases | Success rate (%) | χ2 | p | Electrode dislodgement | Poor pacemaker driving | Complication rate (%) | χ2 | p | ||
| Ultrasound group | 105 | 0 | 0 | 0 | 100 | 194 | .000 | 0 | 0 | 0 | 4.024 | .045 |
| Electrocardiogram group | 89 | 1 | 1 | 2 | 97.75 | 2 | 3 | 5.62 | ||||
3.4. Duration of temporary pacemaker electrode placement and pacing and the age of patients
We conducted univariate linear regression using age as the independent variable and pacing duration as the dependent variable. The results showed that the t‐value of the independent variable age corresponded to a p‐value of .156, higher than the significance level of .05. As a result, we inferred that age and pacing duration were not statistically significant (Tables 4 and 5).
TABLE 4.
Comparison of temporary pacemaker electrode installation time between the two groups.
| Groups | Cases | Duration of central venipuncture (s) | t | p | Duration of pacing (s) | t | p |
|---|---|---|---|---|---|---|---|
| Ultrasound group | 105 | 31.8 ± 3.8 | 83.873 | .000 | 111.2 ± 62.2 | 18.237 | .000 |
| Electrocardiogram group | 89 | 122.9 ± 56.2 | 20.512 | .000 | 288.9 ± 140.7 | 19.374 | .000 |
TABLE 5.
Relationship between pacing duration of temporary pacemakers and age.
| Model | Unstandardized coefficient | Standardized coefficient | t | Significance | ||
|---|---|---|---|---|---|---|
| B | Standard error | Beta | ||||
| 1 | (Constant) | 435.966 | 103.849 | 4.198 | 0 | |
| Age | −2.237 | 1.563 | −0.152 | −1.431 | 0.156 | |
4. DISCUSSION
Temporary pacemaker implantation is a common emergency measure (López Ayerbe et al., 2004) that involves the non‐permanent implantation of a pacing electrode catheter with a pulse generator outside the body. Once the diagnostic or therapeutic purpose is achieved, the pacing electrode catheter is withdrawn.
Compared to jugular or femoral vein puncture, subclavian vein puncture is associated with a lower incidence of infections (Ling et al., 2006; Orihashi et al., 2005). Additionally, after subclavian vein puncture, the central venous catheter can be easily fixed, sterilized, cared for, and indwelt for a long time without impending the neck and limb movements of patients. Hence, the subclavian vein is the preferred approach for central venous cannulation. However, anatomical variants in the subclavian vein (Sun et al., 2011) and thoracic outlet syndrome can cause thinning of the subclavian vein, thereby increasing the difficulty of blind subclavian vein puncture and the incidence of puncture adverse events. Moreover, the success rate of puncture is limited by the skill and experience of the operator.
The axillary vein is located between the clavicle and the lower border of the teres major tendon and is a direct continuation of the subclavian vein. It is situated outside the thorax and below the clavicle, with a superficial and relatively fixed anatomical location and no bony tissues covering it. Therefore, puncture from the axillary vein approach has a high success rate. In particular, in the third segment, the axillary vein is separated from the axillary artery by around 10–15 mm due to the anterior scalene muscle. It is not adjacent to the nerve and is far from the pleural apex, making it less likely to cause pneumothorax during the puncture process. Hence, the axillary vein is another ideal approach for central venipuncture (Chandler et al., 2021; Clark et al., 2019; Liccardo et al., 2018). The third segment of the axillary vein can be chosen as the puncture approach when ultrasound scans of the subclavian vein show variations in its course and a smaller diameter, leading to a higher risk of puncture.
When performing a venous puncture, the sound beam plane of the probe should be aligned with the puncture angle of the needle, and the two‐dimensional section should highlight the long axis section with the largest vein diameter. It is important to know where the needle tip is at all times during a puncture procedure. Before moving on to the next step of the procedure, if the needle tip is not within the ultrasound section, the vessels can be scanned to locate the needle tip. Electrode damage to the vein wall, electrode curling, and even entry into the internal jugular vein can be avoided by inserting the electrode catheter slowly from the subclavian vein into the cephalic vein. If the patient has severe emphysema, poor cardiac sound transmission conditions, and an unclear display of the apical heart section, the pacing electrode can be guided into the apical part of the right ventricle by placing the probe under the xiphoid process and viewing the four‐chamber heart section below the xiphoid process.
In recent years, ultrasound localization or guidance techniques have been increasingly used in clinical practice. Sofoculeous et al. found that ultrasound‐guided 3D localization of selected veins is important for understanding the anatomical relationship between veins and arteries (Sofocleous et al., 1998). It can provide rapid, safe, and effective support for central venipuncture. Color Doppler ultrasound can quickly and accurately display the location and motion of subclavian arteries and veins, as well as the location of the pulmonary apex (Aguilera et al., 2000; Pinneri et al., 2003, 2013). It does so based on the vessel wall structure, venous valve opening/closing, the pulsation and respiratory phase of the vessel wall, color blood flow imaging, and pulsed Doppler measurements, and the strong echogenic reflection waves of lung gases. This helps in determining the safe puncture site and angle and in observing the needle tip location in real‐time, preventing pneumothorax and hemopneumothorax caused by inadvertent arterial puncture and lung puncture. The results of our study revealed that ultrasound guidance resulted in a 100% success rate (105 out of 105 cases) for central venous puncture, while only 79 out of 89 cases (88.7%) in the electrocardiogram group were successful. Notably, 10 cases in electrocardiogram group that initially failed, had a successful puncture after the guidance was switched to ultrasound, indicating the superior accuracy of this technique. In terms of safety, there were no instances of arterial mis‐puncture, pneumothorax, and hemopneumothorax in the ultrasound group, while there were six cases of hematoma at the puncture site, two cases of arterial mis‐puncture, and two cases of pneumothorax in the electrocardiogram group. These differences were statistically significant.
Color Doppler ultrasound is an effective tool for minimizing damage to the venous intima and valves during puncture and preventing venous thrombosis by clearly showing the lumen of the vein and the position, and opening/closing of venous valves (Aguilera et al., 2000; Pinneri et al., 2003, 2013). In addition it can also provide valuable information on the connection between the heart and large vessels, the structure and function of atrioventricular valves, and guide the pacing electrode from the venous lumen into the right atrium through the venous valve and into the right ventricle through the tricuspid valve ostium. This can help prevent electrodes from being sent into or stuck in other non‐target locations due to venous variation, abnormal connection of large vessels, or heart malformation. Likewise, color Doppler ultrasound is an invaluable tool in guiding the placement of a pacing electrode, providing a clear visualization of the right ventricular cavity, and allowing for precise positioning of the electrode on the papillary muscle. This significantly reduces the risk of electrode dislodgement. The ultrasound group exhibited no adverse events and demonstrated accurate anchoring of electrodes, excellent pacing performance, and no electrode dislodgement. In contrast, the electrocardiogram group experienced multiple adverse events such as two cases of failed guidewire passage, one case of inadvertent entry into the coronary sinus, one case of electrode dislodgement on the first postsurgical day, one case of electrode dislodgement on the second postsurgical day, and three cases of poor pacemaker driving. A statistically significant difference was observed between the two groups, underscoring the superiority of ultrasound guidance in this procedure.
5. CONCLUSION
In summary, ultrasound guidance at the bedside is a highly advantageous tool for accurate placement of temporary pacemaker electrode catheters. Not only can it monitor the route of the puncture needle and electrode catheter throughout the process, but it is also portable, easy to operate, safe, effective, and cost‐efficient, with no radiation to patients. The high success rate achieved using ultrasound further supports its clinical promotion and application as a crucial tool in temporary pacemaker placement. The only limitation is that this technique requires a professional ultrasound physician with an in‐depth understanding of vascular and cardiac ultrasound.
AUTHORS' CONTRIBUTIONS
Shao‐Dan Feng, Xiao‐Feng Huang, Hong‐Bin Cai, and Zhi‐Hong Lin contributed to conception and design of the research. Rong‐Quan Xu, Xiao‐Feng Huang, and Ping‐Qing Guo contributed to acquisition of data and analysis and interpretation of the data. Rong‐Quan Xu and Xiao‐Feng Huang contributed to statistical analysis and writing of the manuscript. Shao‐Dan Feng, Rong‐Quan Xu, Xiao‐Feng Huang, Hong‐Bin Cai, and Zhi‐Hong Lin contributed to obtaining financing. Shao‐Dan Feng, Rong‐Quan Xu, and Xiao‐Feng Huang contributed to critical revision of the manuscript for intellectual content. All authors read and approved the final draft.
FUNDING INFORMATION
This work was supported by the (1) Leading Project Foundation of Science and Technology, Fujian Province (No. 2020Y0032) and (2) Fujian Province Finance Project (No. BPB‐FSD2021).
CONFLICT OF INTEREST STATEMENT
The authors declare that they have no competing interests.
ETHICS APPROVAL AND CONSENT TO PARTICIPATE
The study was conducted in accordance with the Declaration of Helsinki (as was revised in 2013). The study was approved by Ethics Committee of the First Affiliated Hospital of Fujian Medical University (No. [2020]198). Written informed consent was obtained from all participants.
ACKNOWLEDGMENTS
We are particularly grateful to all the people who have given us help on our article.
Xu, R.‐Q. , Huang, X.‐F. , Guo, P.‐Q. , Cai, H.‐B. , Feng, S.‐D. , & Lin, Z.‐H. (2023). Ultrasound‐guided pacemaker implantation at the bedside: A lifesaving technique for cardiac emergencies. Annals of Noninvasive Electrocardiology, 28, e13071. 10.1111/anec.13071
Rong‐Quan Xu and Xiao‐Feng Huang contributed equally to this study.
DATA AVAILABILITY STATEMENT
All data generated or analyzed during this study are included in this article. Further enquiries can be directed to the corresponding author.
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Associated Data
This section collects any data citations, data availability statements, or supplementary materials included in this article.
Data Availability Statement
All data generated or analyzed during this study are included in this article. Further enquiries can be directed to the corresponding author.