Abstract
Background
Left Bundle Branch Area Pacing (LBBaP) is a cardiac pacing technique designed to mimic the natural conduction system of the heart. Traditional right ventricular apical pacing has been associated with increased risks of heart failure and atrial fibrillation. This study investigates the stability and safety of LBBaP using the Selectra 3D sheath (Biotronik) with an inclined angle for implanting the Solia S lead (Biotronik, SE & Co, KG).
Methods
A single-center retrospective study was conducted on 25 patients who underwent LBBaP implantation using the Selectra 3D sheath at our hospital. The procedure involved inserting the Solia S lead into the interventricular septum at an inclined angle. Surgical and postoperative data were collected, including the success rate, depth and angle of electrode insertion, complications, and follow-up data.
Results
The success rate of LBBaP implantation was 92%. The length of electrode insertion into the interventricular septum ranged from 12 to 23.0 mm, with an average of 18.1 ± 3.08 mm. The angle formed between the electrode and the septum ranged from 0° to 57.3°, with an average of 35.14°±14.31°. During the 3-month follow-up period, pacing parameters remained stable, and no complications were reported.
Conclusions
LBBaP implantation using the Selectra 3D sheath with an inclined angle for the Solia S implantation demonstrates stability and safety. The procedure boasts a high success rate and offers an effective option for LBBaP implantation.
Keywords: Left bundle branch area pacing, Selectra 3D sheath, Solia S lead, Stability, Safety
Introduction
Left Bundle Branch Area Pacing (LBBaP) is an advanced cardiac pacing technique designed to closely replicate the natural conduction system of the heart. In contrast, traditional right ventricular apical pacing falls short in simulating normal cardiac conduction and has been linked to elevated risks of heart failure and atrial fibrillation [1–3]. LBBaP, which targets the left bundle branch area, offers a superior approximation of natural cardiac conduction, and mitigates conduction disparities across different ventricular walls [4, 5] Consequently, it holds significant promise for clinical applications.
Prior investigations into LBBaP implants have typically employed a perpendicular approach [6, 7], involving electrode insertion into the septum at a shorter distance with the helical connector positioned on the outer side. This configuration has raised concerns regarding an increased risk of lead fracture. This study investigates the stability and safety of LBBaP using the Selectra 3D sheath with an inclined angle for Solia S lead implantation, specifically with the helical connector positioned on the inner side of the septum.
Materials and methods
Study population
This single-center retrospective involved 25 consecutively enrolled patients who underwent LBBaP using the Selectra 3D sheath at our hospital from December 2022 to August 2023. The study cohort comprised 18 males and 7 females, with ages ranging from 28 to 86 years. All patients met the Class I or IIa indications for pacing [8, 9]. The Ethics Committee of our hospital granted approval for the study and all patients provided their written informed consent before participating in this study (Fig. 1).
Fig. 1.
Study flow diagram. LBBaP, left bundle branch area pacing; RSP: right ventricular pacing ; RAP: right ventricular apical pacing; PQRSD: pacing QRS duration; LVAT: left ventricular activation time
LBBaP implant procedure
The LBBaP procedure was conducted via the left subclavian or left axillary vein using a 9 Fr peel-away sheath. Under fluoroscopic guidance in the right anterior oblique 30° view, the Solia S lead, accompanied by a guiding wire, was introduced into the sheath, allowing the electrode tip to slightly protrude. The choice of the appropriate sheath was based on preoperative echocardiography measurements of the atrium size. The sheath and electrode tip were advanced to reach the 3/5 area of the ninth zone with confirmation of septal orientation at angles about LAO 30° view [10]. A butterfly clip was used to rotate the lead 12–14 turns until the entire helix was fully exposed and securely affixed to the endocardium. Subsequently, a green wire connector was attached and rotated nine turns to maintain internal coil tension. Pacing at 2.0 V @ 0.42 MS was initiated from the right side of the IVS. Successful LBBaP was indicated by the presence of a typical “w” pattern in lead V1 with a notch at the nadir of the QRS complex, along with a discordant polarity in leads II and III. This discordance indicated a predominantly positive QRS in lead II and a predominantly negative QRS in lead III. To guide the pacing lead to the left side of the septum, the electrode wire was slowly rotated clockwise for four turns. The depth of rotation was adjustable based on preoperative ultrasound measurements of IVS thickness. Throughout the rotation process, the black unipolar bridging wire clip continuously monitored pacing impedance and QRS morphology. If the QRS morphology in V1 exhibited characteristics of right bundle branch block during pacing, indicating that the electrode was in the left bundle branch area, intraoperative recording of pacing parameters (threshold, impedance, and sensing), left ventricular activation time (LVAT) from lead V5 to the pacing spike, QRS duration, and ECG and imaging data were obtained. Finally, at LAO 30–40 degrees, contrast imaging was performed to determine the depth of electrode insertion. The criteria for successful LBBaP were as follows: [1] QRS morphology showing right bundle branch block or the presence of an “r” wave in lead V1, and [2] consistently short and low-voltage LVAT measured during pacing from the pacing electrode to the peak of the R wave [6, 11].
Once the position was confirmed, and the parameters were deemed ideal, the wire was retracted 10 cm while ensuring the stability of the electrode. The sheath was also retracted, leaving a sufficient reserve of the electrode tip under fluoroscopic guidance. If the position was not ideal, the electrode was loosened and removed to observe if there was tissue attached to the tip. The entry process was then repeated until proper positioning was achieved [7].
Clinical baseline data, electrocardiogram (EKG) recordings, indications for pacemaker implantation, intraoperative electrode wire parameters, QRS morphology, LVAT, intraoperative complications, and postoperative echocardiographic evaluation of the position of the LBBaP electrode in the interventricular septum were documented. Follow-up assessments at 1- and 3-months post-procedure involved monitoring changes in pacing parameters and the occurrence of complications.
Statistical analysis
SPSS 26.0 statistical software was utilized for comprehensive data analysis. The normality and homogeneity of variance of the experimental data were assessed, and results are expressed as mean ± standard deviation ( 
± s). Categorical variables are presented as counts and percentages, and comparisons were made using χ2 test or Fisher’s exact test. All statistical tests were two-sided, with a p-value < 0.05 considered statistically significant.
Results
General participant characteristics
A total of 25 patients were enrolled in the study, with a successful LBBaP rate observed in 23 cases (92%). Among the successful cases, 18 patients utilized the 3D-55-39 sheath, while 5 patients had the 3D-65-39 sheath. Among the two cases that did not achieve successful LBBaP, one patient presented with a significantly enlarged right atrium measuring 81 mm. In this case, the 3D-65-39 sheath could not traverse the valve, necessitating conventional pacing as an alternative approach. The other case presented challenge in accurately performing LBBaP during the procedure and were subsequently converted to conventional pacing.
Of the 23 successful LBBaP cases, 16 were male (69.57%) and 7 were female (30.43%). The average age of the successfully paced individuals was (68.67 ± 13.79) years. Among these cases, 17 (73.91%) were diagnosed with atrioventricular block (AVB), while 6 (26.09%) exhibited sick sinus syndrome. Furthermore, eight patients were under antiplatelet or anticoagulant medication treatment, as detailed in Table 1.
Table 1.
Baseline patient characteristics (N = 23)
| Characteristic | Value |
|---|---|
| Age (y) | 68.67 ± 13.79 |
| Men (%) | 16(69.57) |
| Cr(umol/L) | 72.62 ± 28.77 |
| K (mmol/L) | 4.06 ± 0.33 |
| Clu (mmol/L) | 5.61 ± 1.73 |
| hs-CRP(mg/L), median(IQR) | 1.25(1.89) |
| Type of disease | |
| Sinus node dysfunction (n, %) | 6(26.09) |
| AV conduction disease (n,%) | 17(73.91) |
| Cardiac ultrasound | |
| Right atrium -length (mm) | 50.67 ± 7.54 |
| Right atrium -width (mm) | 38.94 ± 8.39 |
| Right ventricle (mm) | 22.06 ± 4.07 |
| Left ventricle (mm) | 48.94 ± 3.31 |
| Interventricular Septum (mm) | 8.65 ± 1.06 |
| Ejection Fraction (mm) | 61.55 ± 6.52 |
| Comorbidity | |
| Hypertension (%) | 10(43.48) |
| Diabetes (%) | 3(13.04) |
| Coronary artery disease (%) | 5(21.74) |
| Cerebral infarction (%) | 2(8.70) |
| Anticoagulant/antiplatelet drugs (%) | 8(34.78) |
| Rivaroxaban 15 mg qd | 2(8.70) |
| Dabigatran 150 mg bid | 1(4.35) |
| Aspirin 100 mg qd | 1(4.35) |
| Clopidogrel 75 mg qd | 1(4.35) |
| Aspirin 100 mg qd & Clopidogrel 75 mg qd | 3(13.04) |
Changes in LBBaP electrocardiographic parameters
Following the successful implantation of the LBBaP pacemaker, the postoperative EKG revealed four distinct V1 lead morphologies: Qr, QS, and rSr, with corresponding frequencies of 52.17%, 17.39%, and 30.43% (Fig. 2). The duration of the post-QRSD interval, measured after the procedure, averaged 111.91 ± 18.41ms, which is slightly shorter than the pre-QRSD interval of 116.29 ± 31.95ms. However, it is important to note that this difference lacked statistical significance. Furthermore, the LVaT recorded on the V5 lead was reported as 71.71 ± 8.17ms (Table 2).
Fig. 2.
The morphology of lead V1 of EKG in patients with successful LBBaP
Table 2.
Clinical data on electrocardiograms, follow-up pacemaker parameters, and complications
| Parameters | Value | P-value |
|---|---|---|
| ECG parameters | ||
| pre-QRSd | 116.29 ± 31.95 | 0.59 |
| post-QRSd | 111.91 ± 18.41 | |
| LVaT | 71.71 ± 8.17 | |
| Electrode parameters | ||
| threshold(immedia) | 0.73 ± 0.16 | 0.001** |
| threshold (one-month) | 0.85 ± 0.16 | |
| threshold(three-month) | 0.65 ± 0.15 | |
| R-wave amplitude(immedia) | 11.48 ± 3.22 | 0.615 |
| R-wave amplitude (one-month) | 11.07 ± 2.73 | |
| R-wave amplitude(three-month) | 12.04 ± 3.53 | |
| Impedance (immedia) | 616.19 ± 158.48 | 0.398 |
| Impedance (one-month) | 571.43 ± 129.02 | |
| Impedance (three-month) | 562.67 ± 117.11 | |
| Intraoperative complications | ||
| Septal dissection | 1(4.35) | - |
| Ventricular septal perforation | 1(4.35) |
Depth and angle of electrode insertion into the IVS
Subsequent to the procedure and prior to sheath removal, a fluoroscopy-guided imaging examination was performed at LAO 30–40°. The results of the fluoroscopy revealed that the length of electrode insertion into the IVS varied within a range of 12 to 23.0 mm, with an average depth of 18.1 ± 3.08 mm. Additionally, the angle formed between the Solia S lead and the IVS ranged from 0° to 57.3°, with an average angle of 35.14°±14.31° (Fig. 3). Correlation analysis revealed a significant positive relationship between the angle and the depth of the Solia S lead insertion (P <0.05).
Fig. 3.
LBBaP electrode implantation A, the Selectra 3D Sheath angiography and measurement the angle between Sheath and IVS and the depth of electrode implantation; B, electrocardiogram after LBBaP implantation; C, schematic diagram of LBBaP implantation at an angle; D, post-implantation echocardiography indicating electrode placement on the endocardial surface of the left ventricle (red pentagram). AVN: atrioventricular node; LBB: left bundle branch; RBB: right bundle branch; HB: His’s bundle; IVS: interventricular septum
Complications and safety of LBBaP
During the immediate implantation procedure, two noteworthy incidents were observed, including one instance of ventricular perforation and one occurrence of an intraventricular septal dissection. It was evident that the risk of intraoperative complications, such as dissection and perforation, tended to increase when the depth of electrode implantation exceeded 20 mm or when the angle of electrode implantation exceeded 50° (Fig. 4). However, it is important to emphasize that all patients underwent the necessary adjustments, and the LBBaP implantation procedures were ultimately successfully completed. These surgical interventions were performed using an electrotome, and no complications were reported in any of the cases.
Fig. 4.
The scatter plot between the depth of the Solia S electrode and the angle of Selectra 3D Sheath and IVS, The red dots represent cases with complications
Throughout the 3-month follow-up period, a noteworthy observation was a slight increase in the average threshold after 1 month, followed by a subsequent decrease. Furthermore, there were no complications such as electrode dislocation, hematoma, infection, or any abnormalities in perception or impedance reported during this period.
Discussion
This article presents the findings of a short-term follow-up study on LBBaP implantation using the Selectra 3D sheath at an inclined angle. The study achieved a success rate of 92% (23/25) in LBBaP implantation. During the follow-up period, the pacing parameters remained stable, and no complications were reported. This innovative approach provides an effective alternative for LBBaP implantation compared to conventional lead implantation.
Compared to the 3830 lead, the advantage of LBBaP lies in the frequent use of a 4.1Fr narrow non-lumen-fixed helical wire (SelectSecure 3830 lead) delivered through the fixed curved sheath (C315HIS, Medtronic Inc). This wire’s equal-diameter shape between the tip and the body facilitates screwing the wire into the septum, resulting in a high implantation success rate and excellent pacing thresholds, particularly in patients with QRS complex narrowing, atrioventricular conduction block, and bundle branch block [12]. Sun et al. [13]. achieved a 92% success rate in LBBaP pacing using the FINELINE II 4471 lead (Boston Scientific). Notably, this lead features a unique design, characterized by a non-conductive helix with an unequal diameter of 1.6 mm before the cathode. Additionally, the body diameter of this lead is 5.1Fr, while it features a narrower tip compared to other leads [14]. By employing a 5.6Fr-style lead with a retractable helix, such as the Solia S pacing lead, and a pre-shaped sheath (Selectra 3D), the wire can be easily rotated towards different regions [15, 16], including the bundle branch, left anterior fascicle, or left posterior fascicle, without the constraints of a larger lead diameter (5.6Fr) or the non-equal-diameter design of Solia S. The larger outer diameter of Solia S allows for better control of the lead body during manual rotation. The thicker electrode and robust Selectra 3D provide stable support for the easy rotation of Solia S into the septum. Importantly, both the tip and the wire inside the electrode are conductive in Solia S, allowing real-time continuous monitoring of intracavitary electrograms and electrode parameter changes, which is a notable advantage compared to the 3830 lead, employing electrophysiological multipliers [17, 18].
The stability and safety of LBBaP implantation may be better achieved with an angular approach. Previous studies have demonstrated the extensive nature of the left bundle branch, which extends even to the His bundle area [19, 20]. This versatility enables the placement of the LBBaP at different regions, such as the left bundle branch, left anterior fascicle, or left posterior fascicle. Pacing with LBBaP typically results in a narrow QRS complex, short left ventricular activation time, stable pacing parameters, and similar intraventricular and intraventricular synchronicity to normal patients, as evidenced by echocardiography [21]. Consequently, physiological pacemakers can be successfully applied across various branches, from the His bundle to LBBaP. Clinical trials have confirmed that Seletra 3D exhibits a non-inferior success rate in LBBaP implantation compared to C315his + 3830 leads [7]. This study underscores that successful LBBaP pacing can be achieved with the electrode entering the septum at angles ranging from 0° to 60°. The distance from the tip to the of the ring measures 14.8 mm, and the septal thickness typically ranges from 7 to 10 mm. If the entry angle is too shallow, there is a risk that the edge of the ring may extend beyond the septum, potentially raising concerns about the long-term stability of the ring-electrode connection. This aspect necessitates further investigation to ensure the sustained mechanical integrity of the electrode in situations of prolonged swinging. However, when the angle of entry into the septum is set at 35°, and the insertion length inside the septum reaches 18 mm, it can be reliably ensured that the ring is positioned securely within the septum. This configuration not only ensures the mechanical stability of the electrode but also opens the possibility of dual pacing across the septum, ultimately leading to a shorter QRS duration [21]. Nonetheless, as our study demonstrates, it is important to recognize that there is an elevated risk of complications, such as dissection and perforation, during the procedure when the depth of electrode implantation exceeds 20 mm or the angle of electrode implantation exceeds 50°.
Our study provides valuable insights into the immediate and short-term follow-up of LBBaP implantation using the Seletra 3D sheath and Solia S electrode, highlighting stable threshold, impedance, and perception parameters. Despite a minor threshold increase after 1 month, which subsequently returned to safe levels, our results confirm that Solia S electrode implantation for LBBaP remains safe and stable during short-term follow-up. Notably, only one case of intraventricular electrode perforation and one case of intraventricular dissection occurred during the study, both of which were effectively managed by adjusting the electrode position, with no serious consequences observed. These findings underscore the significance of adhering to strict surgical implantation procedures, closely monitoring EKG changes during electrode rotation, observing impedance changes [20] (considering intraventricular perforation when the impedance drops by 200Ω), and, most importantly, conducting postoperative sheath imaging to assess the depth of electrode penetration and the presence of complications such as perforation or hematoma. These measures are crucial for ensuring the safety and success of LBBaP implantation.
Conclusion
The utilization of the angular approach with the Seletra 3D sheath and Solia S electrode for LBBaP implantation has demonstrated good stability and safety during short-term follow-up. To optimize results, it is advisable to limit the depth of electrode insertion to 20 mm and maintain an angle of less than 50°. This novel method provides a promising and effective alternative for LBBaP implantation. Nevertheless, it should be noted that this study represents a single-center study with a relatively modest sample size. To establish the long-term safety and feasibility of this approach conclusively, further large-scale, multi-center randomized studies and real-world clinical practice assessments are warranted.
Acknowledgements
All subjects gave their informed consent for inclusion before they participated in the study. The study was conducted in accordance with the Declaration of Helsinki, and the protocol was approved by the Ethics Committee of Affiliated Hospital of Wannan medical College.
Abbreviations
- LBBaP
Left bundle branch area pacing
- LVAT
Left ventricular activation time
- EKG
Electrocardiogram
- AVB
Atrioventricular block
- IVS
Interventricular Septum
- PQRSD
Pacing QRS duration
- AVN
Atrioventricular node
- LBB
Left bundle branch
- RBB
Right bundle branch
- HB
His’s bundle
Author contributions
CLJ designed the study and wrote the manuscript. CLJ and CK performed LBBaP for the patients and collected the data for the article. YZ and XYX analyzed the data and reviewed the manuscript. All authors contributed to the article and have approved the submitted version.
Funding
This study was supported by the Key Specialty Project of Anhui Province Medical and Health.
the Key Project of Education Department of Anhui Province (Award Number: KJ2021A0822 and 2022AH051238). Enterprise-commissioned R&D projects (NO:662202304016).
Data availability
The original contributions presented in the study are included in the article material; further inquiries can be directed to the corresponding authors.
Declarations
Ethics approval and consent to participate
All subjects gave their informed consent for inclusion before they participated in the study. The study was conducted in accordance with the Declaration of Helsinki, and the protocol was approved by the Ethics Committee of Affiliated Hospital of Wannan Medical College.
Consent for publication
Not applicable.
Competing interests
The authors declare no competing interests.
Footnotes
Publisher’s Note
Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.
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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
The original contributions presented in the study are included in the article material; further inquiries can be directed to the corresponding authors.