|Year : 2019 | Volume
| Issue : 2 | Page : 61-67
Permanent his bundle pacing guided by three-dimensional mapping system: An observational study (English version)
Jifang Ma, Xiaobiao Zang, Haixia Fu, Weifeng Song, Ke Chen, Xianqing Wang, Yonghui Zhao
Department of Cardiology, The Henan Provincial People's Hospital/Fuwai Central China Cardiovascular Hospital, Zhengzhou, Henan Province, China
|Date of Submission||25-Mar-2020|
|Date of Acceptance||17-Apr-2020|
|Date of Web Publication||15-Jun-2020|
Dr, Yonghui Zhao
Department of Cardiology, The Henan Provincial People's Hospital/Fuwai Central China Cardiovascular Hospital, Zhengzhou 450003, Henan Province
Source of Support: None, Conflict of Interest: None
Background: Permanent His bundle pacing (HBP) is a promising therapy in cardiac pacing field with high challenge of the heart structure. Cardiac mapping system provides us a comprehensive model of heart structure. The study aimed to investigate the feasibility and efficacy of HBP guided by three-dimensional (3D) mapping system. Subjects and Methods: Thirty patients undergoing permanent HBP through 3D mapping system were enrolled in this observational study between January 2016 and May 2018. The study was approved by the Ethics Review Committee of Fuwai Central China Cardiovascular Hospital. The average age of the study population was 59.2 years old, with 17 male patients. Factors including the whole operation time, the X-ray exposure time, the lead parameters, and QRS duration before and after the surgery were analyzed. Results: The study population was divided into two groups: 20 patients in selective HBP group (only capture His bundle) and 10 patients in nonselective HBP group (capture both His bundle and Para-Hisian ventricular tissue). The average whole operation time of HBP guided by 3D mapping system was 113 minutes, and there is no significant difference in the X-ray exposure time between selective HBP and nonselective HBP (P > 0.05). Four patients received HBP with zero fluoroscopy. The intraprocedural lead parameters threshold was significantly increased (1.80 ± 0.50 V vs. 1.21 ± 0.41 V) while sensing was significantly decreased (3.30 ± 0.63 mV vs. 7.40 ± 0.99 mV) in the selective HBP group compared with in the nonselective HBP group (P < 0.05 and P < 0.01). Conclusion: The permanent HBP guided by 3D mapping system was feasible clinically in decreasing X-ray exposure time and achieving perfect lead parameters.
Keywords: Atrioventricular block, bradycardia, His bundle pacing, pacemaker, sinus node dysfunction, three-dimensional mapping
|How to cite this article:|
Ma J, Zang X, Fu H, Song W, Chen K, Wang X, Zhao Y. Permanent his bundle pacing guided by three-dimensional mapping system: An observational study (English version). Int J Heart Rhythm 2019;4:61-7
|How to cite this URL:|
Ma J, Zang X, Fu H, Song W, Chen K, Wang X, Zhao Y. Permanent his bundle pacing guided by three-dimensional mapping system: An observational study (English version). Int J Heart Rhythm [serial online] 2019 [cited 2020 Jul 4];4:61-7. Available from: http://www.ijhronline.org/text.asp?2019/4/2/61/286764
This manuscript is an English version based on Ma J, Zang X, Fu H, Song W, Chen K, Wang X, Zhao Y. Permanent His pacing guided by three-dimension mapping system. Chin J Cardiac Arrhyth 2020;24 (1):53-59. DOI: 10.3760/cma. j. issn. 1007-6638.2020.01.010. The second publication of this manuscript has obtained the permission from Chinese Journal of Cardiac Arrhythmias.
| Introduction|| |
Permanent His bundle pacing (HBP), a physiological approach of ventricular activation, has emerged as the hotspot in the field of cardiac pacing. However, due to the limitation of His bundle area anatomy, conventional HBP faces lots of problems such as complicated procedure, lead implantation difficulty, unsatisfactory pacing threshold, and excessively long operation time leading to a sharp increase in X-ray exposure time. Now, three-dimensional (3D) cardiac mapping system provides us a comprehensive model of heart structure for shorter X-ray exposure time in cardiac ablation surgery. However, combined 3D cardiac mapping system with HBP technology had not been reported. This study aimed to analyze the relevant data of HBP guided by 3D mapping system in the past 2 years.
| Subjects and Methods|| |
A total of 30 patients from Henan Provincial People's Hospital/Fuwai Central China Cardiovascular Hospital, who underwent permanent HBP from January 2016 to May 2018, were enrolled sequentially. All the patients implanted with permanent HBP met the following eligible criteria:
- Clinical symptoms associated with bradycardia (e.g., chest distress, dizziness, darkening, and syncope)
- Patients with indications for pacing, including atrioventricular block (AVB) (e.g., symptomatic second-degree II-type AVB, third-degree AVB, and high-degree AVB) and sinus node dysfunction (e.g., symptomatic sinus bradycardia, sinus arrest, and/or atrial fibrillation with slow ventricular rate).
Patients with poor cardiac function combined with wide QRS duration, rheumatic valve disease with heart failure and expected survival >1 year.
All patients were asked to complete all the laboratory tests such as hepatic, renal and coagulation function, blood, urine, and stool routine. Echocardiography, orthotopic chest X-ray, 24-hour Holter and other related examinations were also demanded. The informed consent of the HBP surgery was signed. This study met the requirements of the Declaration of Helsinki and approved by the Ethics Review Committee of Fuwai Central China Cardiovascular Hospital.
According to the implantation site of the His bundle lead, the patients were divided into a selective HBP group (captured only with a His bundle) and a nonselective HBP group (captured with a His bundle and a paraventricular tissue). Selective HBP was performed in 20 patients (66.7%), and nonselective HBP was performed in 10 patients.
The implantation process of His bundle pacing
The HBP lead is an active fixation lead (model 3830, Medtronic Inc., Minneapolis, MN, USA). There are two main types of 3D mapping systems: Carto 3 (Johnson and Johnson Inc., Piscataway, NJ, USA) and Ensite V4 (Abbott Inc., Chicago, IL, USA). The 3D mapping system guided the implantation of the permanent HBP in three steps.
First, construct a 3D anatomical model of the right atrium, perform local disinfection and draping. After local anesthesia with 1% lidocaine was given, puncture the right femoral vein and send it to the ordinary 4 mm ablation catheter (Carto 3 system) through the right femoral vein or deflec[table 10]-pole lead (Ensite V4 system). Through the 3D mapping system, a 3D anatomical model of the right atrium and the tricuspid annulus can be constructed. The His bundle is located above the tricuspid septum and the posterior edge of the ventricular septal membrane, where a large His bundle potential can be mapped, shown with a solid yellow dot on the 3D model.
Second, a His bundle lead was implanted, the left subclavian vein or left axillary vein was punctured, and the His bundle sheath (C315, Medtronic) was placed in the right atrium through the left subclavian vein or left axillary vein. The C315 sheath was used to feed the active fixation lead to the right atrium, and the tail end of the active fixation lead was connected to the transfer tail wire, thus the lead end can be displayed in the 3D mapping system, and its potential can be displayed in real time on the 3D mapping system display screen. By adjusting the guide wire and outer sheath counterclockwise, the angle and direction of the His bundle sheath and the implantation site should be as perpendicular and coaxial as possible, and the active fixation lead was adjusted in the anterior space region. Push the C315 sheath along the active fixation lead until the distal end of the lead was exposed about 0.5 cm. With the support of the sheath of His bundle, we adjusted the lead to the area of His bundle (shown by the yellow solid point on the 3D model) region. In this way, no X-ray irradiation or minimal X-ray irradiation was required, and the active fixation lead end can be placed on the previously marked His bundle position on the 3D model (can be tilted 30° from the right anterior oblique [RAO] and 45° from the left anterior oblique [LAO] at the same time to confirm [Figure 1]). The active fixation lead potential can record the apparent sharp His bundle potential (bipolar recording, filtering: 30–300 Hz), i.e. to determine the position of His bundle, turn the tail of the wire clockwise 4 times to fix the wire, sheath the end of the wire, and then gently withdraw the C315 sheath. According to the demand, some patients can be verified under X-ray irradiation. The 30° from the RAO and 45° from the LAO were usually used to determine whether the fixation lead was correctly placed in the His bundle area [anterior interval area; [Figure 2].
|Figure 1: 3D mapping of the HBP lead. (a) 3D (Ensite V4) reconstruction model of the right atrium and HBP (right anterior oblique 45° is on the left, and left anterior oblique 45° is on the right). (b) HBP active fixation lead (3830) can be recorded locally with clear His bundle potential (shown by white arrow). (c) Active fixation lead pacing figure. Vp-V interval=HV interval. The yellow solid dots are the proximal end of His bundle as measured by the catheter, the blue solid dots represent the distal end of His bundle, and the small green dots represent the real-time position of the active fixation lead of His bundle, recording His bundle potential which shows the location of His bundle area. HBP=His bundle pacing, 3D=Three-dimensional|
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|Figure 2: X-ray image of the HBP lead. (a) Right anterior oblique 30° image. The black arrow shows the HBP lead. (b) Left anterior oblique 45° image. The black arrow shows the HBP lead. HBP=His bundle pacing|
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Finally, lead parameters were programmed to confirm the HBP. Directly perform a pacing test on the active fixation lead (2 V, 0.4 ms). Observe whether the paced QRS morphology was consistent with the QRS morphology in sinus rhythm, and measure the interval from the pacing signals to the ventricular activation in the intracardiac electrocardiogram (Vp-V interval) and compare it with the His bundle-ventricular activation interval under sinus rhythm [HV interval; [Figure 3].
|Figure 3: Comparison of 12-lead ECG results before and after HBP in patients. (a) This patient has a first-degree AVB with intermittent second-degree II-type AVB, and conventional ECG before surgery suggested a long-term AVB (PR interval was 290 ms). (b) The QRS duration of the postoperative ECG was 90 ms, and the 12-lead ECG QRS duration of the HBP was basically the same as the preoperational QRS duration. There was an equipotential line between the pacing signal and the QRS duration, suggesting selective HBP. AVB=Atrioventricular block, HBP=His bundle pacing, ECG=Electrocardiographic|
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According to the current domestic and international guidelines for HBP, there was a significant difference in the wire parameters between selective and nonselective HBP. Selective HBP required capturing only the His bundle: threshold value <3 V/0.5 ms, sensing >2 mV (minor criteria); 1:1 HV conduction >130 times/min. When the nonselective His bundle paced low voltage, the local myocardium was captured first. However, increasing the voltage can capture both the local myocardium and the His bundle. Therefore, there were two thresholds. A value of threshold 2 was the minimum voltage to capture the myocardium and the His bundle (generally a broad value of threshold 1 <a broad value of threshold (2), and the parameter requirements were the same as those of the selective HBP (threshold value <3 V/0.5 ms, sensing >2 mV). Take the threshold 2 as a reference to program the voltage of the His bundle lead to ensure the HBP as much as possible. If the pacing parameters did not meet the above requirements, unscrew and withdraw the active fixation leads, and then readjust the position according to the operation in the second step above, until the above HBP parameters were met.
Follow-up and study indicators
All patients were followed up routinely at 1, 3, 6, and 12 months after surgery, and longer if necessary. Their recovery was understood through outpatient follow-up and telephone follow-up. Collected clinical study indicators include gender, age, inner diameter of left atrium, left ventricular end diastolic diameter (LVEDD), left ventricular ejection fraction (LVEF), total operation time of the HBP surgery, intraoperative X-ray exposure time, intraoperative programming parameters, and QRS duration changes before and after the surgery. The X-ray exposure during the operation was obtained by the absorbed dose mGy displayed on a DSA machine (Artis Q Biplane, Siemens, Berlin and Munich, Germany). Zero-ray means that the absorbed dose index is zero.
SPSS 19.0 statistical software (IBM, Armonk, NY, USA) was used for analysis. The measurement data that conform to the normal distribution was expressed by the mean ± standard deviation; the categorical data were expressed as a percentage (%). The comparison (continuous variable) between the two subgroups was performed using independent sample t-tests. P < 0.05 was considered statistically significant.
| Results|| |
A total of 30 patients were enrolled, 17 males, with an average age of 59.2 years, including 7 cases of AVB (including second-degree II AVB, third-degree block, and high-degree AVB [atrioventricular conduction proportion > 2:1]), 23 cases of sinus node dysfunction (including sinus bradycardia, sinus arrest, or slow ventricular rate combined with atrial fibrillation). There were 12 patients with atrial fibrillation, 24 with hypertension, 22 with coronary heart disease, 8 with diabetes, and 8 with cardiac insufficiency [Figure 4]. Echocardiography: LVEDD 42.72 ± 5.32 mm, LVEF 47.04 ± 14.26% [Table 1].
|Table 1: Clinical characteristics of patients with the his bundle pacing group under the guidance of the threedimensional mapping system|
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The intraoperative test parameters were ideal. Significantly lower sensing and higher threshold (selecting threshold 2 for comparison) were shown in the selective HBP group compared with the nonselective HBP group [P < 0.05 and P < 0.01; [Table 2]. There was no significant difference in QRS duration before and after surgery between the two groups (P > 0.05). A total of 42 His bundle lead positioning operations were performed in 30 patients, with an average of 1.4 operations to achieve ideal HBP.
|Table 2: Relevant characteristics of His bundle pacing surgery under the guidance of the three-dimensional mapping system|
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Related features of the surgery
Carto 3 system was used in 5 cases and Ensite V4 system was used in 25 cases. The former was modeled with a 4 mm nonsaline ablation catheter, while the latter only required ordinary 10-pole wires for 3D modeling. The total operation time of the HBP under the guidance of the 3D mapping system was 113 minutes on average, which was close to the operation time of the ordinary dual-chamber pacemaker. There was no significant difference in the intraoperative X-ray exposure time between the two groups [P = 0.60; [Table 2], of which four patients completely received zero-ray surgery.
Postoperative follow-up results
No increase in threshold was observed during follow-up. The program-controlled display showed the sensing, impedance, and threshold of the HBP values and other indicators were within the normal range. Of the 30 patients, 28 were routinely followed up (2 were lost to follow-up), and the average follow-up time was (11.9–6.8) months. The parameters for the 6-month follow-up are shown in [Table 3]. The selective HBP group and the nonselective HBP group were compared in terms of impedance, sensing, and threshold (selection threshold 2 was used for comparison). Significantly lower sensing and higher threshold (selecting threshold 2 for comparison) were shown in the selective HBP group compared with the nonselective HBP group at 6 months after surgery [P < 0.05 and P < 0.01; [Table 3]. Twenty-eight patients underwent electrocardiograph (ECG) monitoring at 6 months of follow-up.
|Table 3: Comparison of follow-up parameters at 6 months after his bundle pacing|
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| Discussion|| |
In recent years, reports on the HBP have attracted widespread attention in the field of electrophysiology., His bundle is located above the tricuspid septum and migrates from the deep fibers of the atrioventricular node. It passes through the right fiber triangle to the posterior edge of the interventricular septum and moves forward to the upper edge of the ventricular septal muscle. HBP allows the excitation to be transmitted down the normal conduction system of the heart, maintaining the order of atrioventricular electrical activation and ventricular contraction, which is theoretically the best ventricular pacing site.
As early as 2000, Deshmukh et al. published the first permanent HBP on the journal Circulation and successfully used it in 12 patients with heart failure who had atrial fibrillation and slow ventricular rate. For the first time, a permanent human HBP was achieved. However, it was difficult for some patients to achieve direct HBP. Deshmukh believed that the Para-HBP (nonselective pacing) can also have a similar effect to HBP. There is a lack of consistency in the terminology of HBP, and the latest international guidelines for permanent HBP in 2017 have standardized the unified definition of two forms of HBP: Selective HBP and nonselective HBP. According to the definition of guidelines, the criteria for selective HBP (previously known as direct HBP, pure HBP, or selective-direct HBP) include: (1) in the 12-lead ECG, the morphology and duration of the QRS-T wave generated by pacing are the same as the QRS-T wave of the patient; (2) during electrophysiological examination, the interval from the pacing signal to the ventricular excitation in the intracardiac electrocardiogram is basically equivalent to the His bundle-ventricular excitation interval (ventricular pacing-V interval = His ventricular interval) under the sinus rhythm. Moreover, there is an equipotential line between the pacing signal and the QRS complex; and (3) increasing the pacing output can widen the QRS wave in some patients (The fusion of the His bundle and ventricular muscle capture). Criteria for nonselective HBP: (1) The intracardiac electrocardiogram indicates that the pacing signal-ventricular activation interval is smaller than the His bundle-ventricular activation interval. The pacing point directly captures the myocardium and causes that the equipotential interval from the pacing signal to QRS disappears; (2) some patients can see δ waves in advance at the beginning of the QRS complex; (3) the QRS duration for pacing at low output is wider than the QRS duration under sinus rhythm (local myocardium capture), increasing the pacing output can narrow the QRS duration of some patients (captured by the His bundle and the myocardium); and (4) the time between the pacing signal to the QRS end is not equal to the time interval between the His bundle and the QRS end. The overall electrical axis of the pacing QRS complex is consistent with the QRS electrical axis of the sinus rhythm. From the perspective of cardiac electrical conduction, selective HBP is undoubtedly more ideal, but due to the high threshold of selective HBP and low sensing, for most patients (especially pacemaker-dependent patients), nonselective HBP can also improve the aggression conduction of the heart. The lower the threshold is and the better the sensing is, the safer it may be.
Multiple clinical trials have confirmed that the right ventricular pacing increases the risk of atrial fibrillation and heart failure, both in the right ventricular apical pacing and outflow tract pacing, especially when the pacing ratio was high (>40%).,,, The incidence of atrial fibrillation has increased significantly, which has led to an increase in the rate of heart failure rehospitalization and mortality.,,, Deshmukh and Romanyshyn reported 54 patients with chronic atrial fibrillation, dilated cardiomyopathy, and cardiac dysfunction. The QRS duration was ≤120 ms, LVEF <40%, and cardiac function III-IV (the New York Heart Association classification), LVEF 23% ± 11%, implanted with HBP lead, and performed atrioventricular node ablation with a success rate of 72%. The follow-up lasted for 42 months, and it was concluded that the HBP was safe and can improve cardiac function compared with right ventricular apical pacing. Barba-Pichardo et al. tried to implant the HBP lead in 16 patients who failed the traditional coronary sinus lead implantation. Nine cases were successful, and the left bundle branch block was corrected. With the follow-up of 31.33 ± 21.45 months, LVEDD, end-systolic diameter, ejection fraction, and cardiac function were all improved compared with before surgery. These were consistent with our findings. After follow-up in this study, it was found that the LVEDD was significantly reduced and the LVEF was significantly increased. Some scholars demonstrated the effect and stability of HBP. They used an active fixation lead (Medtronic 3830 lead) to implant HBP in 242 patients. The chronic threshold averaged about 1.4 V/0.5 ms. After the 6-month follow-up in this study, the HBP threshold, sensing, and impedance remained relatively stable.,,,, Wang et al. used real-time 3D-ultrasound technology and myocardial nuclide imaging to evaluate patients with HBP, which can maintain better inter-ventricular and left-ventricular mechanical synchronization than the right ventricular pacing. Sheng et al. also conducted a single-center analysis of the long-term safety and feasibility of permanent HBP. Studies have shown that with a median follow-up of 15 months, the parameters of the HBP lead were stable and the cardiac function of patients after surgery and echocardiographic results were improved from baseline.
HBP currently uses the select secure system.,, The active fixation lead (Medtronic 3830 lead) and the special delivery tool select secure system are used for permanent HBP. The success rate of surgery is over 90%, but beginners still need it takes a long time to complete the implantation of the His bundle lead and the X-ray exposure is much more. X-ray exposure is currently confirmed to be related to a variety of diseases, including leukemia, malignant tumors, and infections. The green electrophysiological interventional treatment technology proposed in recent years is also committed to minimizing intraoperative X-ray exposure to protect the surgeons and patients. The physiological area of the His bundle is very small. The implant range of the HBP lead is only a few centimeters. It is still difficult to accurately fix the active fixation lead (Medtronic 3830 lead) in the His bundle and keep the lead stable, resulting in time-consuming implantation longer. The lead dislodgement rate is higher after implantation, and the dislocation rate for beginners can even reach 7.14%. In addition, the His bundle is wrapped by an insulating fiber sheath, and there are fewer pacing cells nearby, which leads to a higher threshold of the HBP than normal right ventricular pacing. This limits further research and clinical promotion of the HBP. Zanon et al. studied the implantation time of the HBP lead was 19 ± 17 minutes, and the average X-ray exposure time was 11 ± 8 minutes. Barba-Pichardo et al. studied the X-ray exposure time of the implantation of HBP lead as 23 ± 3 minutes. Surgeons often need to perform frequent X-ray to find the ideal site of the HBP, which leads to a significant increase in the burden of X-ray exposure for the surgeon and the patient. The latest Geisinger registration study showed that the X-ray exposure time of the HBP surgery was 10 ± 7 minutes, and we used 3D mapping to guide the HBP. 6.20 ± 4.02 minutes was used in the selective HBP group and 5.30 ± 4.59 minutes was used in the nonselective HBP group for intraoperative X-ray exposure time. Using this method for the operation of the HBP, except for three patients who successfully implanted the HBP lead due to anatomical variations, 30 cases successfully positioned the lead in the vicinity of the His bundle area (91% success rate). It has been reported that the highest success rate of conventional HBP lead implantation was only 85%. Under the guidance of 3D mapping, the success rate of surgery was significantly improved, and the X-ray exposure time was reduced.
Under the guidance of a 3D mapping system (Carto 3 or Ensite V4), the entire right atrium contour was first constructed with a mapping catheter, and the area of the His bundle was clearly marked. The previous problem was how to display the pacing active fixation lead on the 3D mapping system (Carto 3 or Ensite V4). We adopted a transfer tail wire to solve this problem. One end of the tail wire was connected to the active fixation wire, and the other end was connected to the adapter box of the 3D mapping system, so that the far end of the active fixation lead was displayed on the 3D mapping system. The position of the active fixation lead and the His bundle can be judged from the two angles of RAO or LAO, which can shorten the operation time to a maximum extent, reduce the X-ray exposure, and even achieve zero-ray HBP implantation and significantly reduce the dislodgement rate. In this study, the average X-ray exposure time was 5.6 minutes. Four patients underwent complete zero-ray surgery with a postoperative dislodgement rate of zero. For some special patients, who cannot access X-rays, such as pregnancy, hematological diseases, and special tumors, pacemaker implantation is a restricted area. However, by adopting a full 3D mapping method, zero- or very low-radiation pacemaker implantation is acceptable and safe. In terms of surgery costs, the Carto 3 system requires 3D mapping of 4 mm nonsaline infusion catheters. It is suitable for use when the operator has insufficient experience in early 3D mapping. With the accumulation of surgical experience, the surgeon can use the Ensite V4 system and choose ordinary 10-pole wires to build a 3D model of the right atrium and tricuspid annulus. Looking for an ideal target for a His bundle on a 3D model, for beginners, it is undoubtedly possible to fasten the His bundle lead to the ideal area, reduce the X-ray exposure time during surgery, and increase the success rate.
HBP can achieve physiological synchronization and is the most suitable pacing method in physiological sequence. Moreover, the His bundle lead does not cross the tricuspid valve, which avoids problems such as tricuspid regurgitation caused by the wire. The use of a 3D mapping system under the guidance of the implantation of the HBP lead not only shortens the operation time and reduces the exposure, but also achieves the ideal threshold, which is completely feasible in clinical applications.
This study also has some limitations. The total number of cases is relatively small, and it is only a summary of the experience of a small sample in a single center. It needs to be further confirmed by the study of large sample clinical data. Moreover, this study did not carry out a comparative analysis and research with ordinary HBP implantation methods guided by non-3D mapping systems. For the advantages of 3D mapping systems, such as reducing the amount of X-ray exposure, shortening the operation time and the learning curve, further exploration of more randomized controlled studies is needed to confirm.
| Conclusion|| |
The permanent HBP guided by 3D mapping system was feasible clinically in decreasing X-ray exposure time and achieving perfect lead parameters. HBP is a promising physiological pacing method. With the improvement of implantation tools and optimization of surgical methods, more and more patients should be benefited.
Financial support and sponsorship
This study was supported by the Medical Science and Technology Commission Foundation of Henan Province (Nos. 201702154, 201303134).
Conflicts of interest
There are no conflicts of interest.
Institutional review board statement
The study was approved by the Ethics Review Committee of Fuwai Central China Cardiovascular Hospital.
Declaration of patient consent
The authors certify that they have obtained all appropriate consent from patients. In the forms the patients have given their consent for their images and other clinical information to be reported in the journal. The patients understand that their names and initials will not be published and due efforts will be made to conceal their identity forms.
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[Figure 1], [Figure 2], [Figure 3], [Figure 4]
[Table 1], [Table 2], [Table 3]