Cardiac pacing aims to improve our patients’ well-being by adapting heart rate to their physiological needs and may in some instances be lifesaving by avoiding asystole. However, it may also have adverse effects on acute and chronic cardiac pump function. Researchers have been striving to find alternative means of pacing the heart to mitigate these detrimental effects. Right ventricular septal pacing (as an alternative to apical pacing) has had mixed results.1 Cardiac resynchronization therapy (CRT) by biventricular pacing (BVP) has proven to be a success story for treating selected patients with heart failure and there are some data showing that it also preserves ventricular function in patients requiring anti-bradycardia pacing with normal ejection fraction.2 However, this therapy usually requires implantation of more complex systems and may be associated with issues such as elevated thresholds of the coronary sinus lead and phrenic nerve capture.
His bundle pacing (HBP) was first performed in the canine model by Scherlag et al.3 in 1967 and in man in 1970 using temporary leads.4 It was not until 2000 that permanent HBP using standard pacing leads was achieved in man.5 This was a major milestone in physiological pacing but the technique was not widely adopted due to technical challenges. Furthermore, the main focus of research at that time was CRT, and the device industry’s efforts were directed toward developing tools to facilitate implanting leads in coronary sinus tributaries. The advent of the Medtronic (Minnesota, MN, USA) 3830 lumenless 4.1F catheter-delivered lead introduced 20 years ago (initially intended for selective site pacing of the right atrium and ventricle) however opened up new perspectives for HBP and improved success rates compared to traditional stylet-driven leads.6 Positioning and fixation of the 3830 lead on the His bundle region was further facilitated by the introduction of the 3D-shaped C315-His delivery catheter which served to markedly increase HBP adoption since 2017, along with the buzz on social media about the technique.7
Investigators in the Netherlands used an adapted version of the 3830 lead with a long helix positioned deep in the interventricular septum to pace the left ventricular septum. This proved to yield superior acute hemodynamics compared to right ventricular apical and septal pacing.8 The concept evolved to left bundle branch area pacing (LBBAP) introduced by Huang et al.,9 which provided excellent electrical parameters and which has since gained widespread adoption due to excellent electrical parameters (which is the Achilles’ heel of HBP).
FDA approval for the 3830 lead was granted for HBP in 2018 and for LBBAP in 2022. CE-labelling for the 3830 lead and the C304-His catheter (a 3D-shaped deflectable catheter) were obtained for HBP in 2021 (MDR approval is pending for LBBAP). Stylet-driven leads are also used for HBP and LBBAP in clinical practice,10,11 but currently no such leads have received regulatory approval for conduction system pacing (CSP). An overview of the currently approved CSP tools is provided in Table 1.
Table 1.
Currently approved hardware for conduction system pacing (as of July 2023)
| FDA | CE-MDD | CE-MDR | |
|---|---|---|---|
| Abbott | |||
| Tendril STS 2088 lead Ultipace LPA 1231 |
To be submitted in 2023-LBBAP | — | To be submitted in 2024-LBBAP |
| Locator 3D catheter | — | — | To be submitted in 2023 for generic indications |
| Direct 3D | — | — | Generic indications |
| Biotronik | |||
| Solia lead | IDE trial ongoing | — | In preparation |
| Selectra 3D catheter | IDE trial ongoing | — | Approved for HBP + LBBAP |
| Amvia pacemaker | IDE trial ongoing | — | Approved for LBBAP |
| Boston Scientific | |||
| Ingevity + lead | — | — | — |
| SSPC catheters | — | — | — |
| Medtronic | |||
| SelectSecure™ MRI SureScan™ Model 3830 Pacing Lead | Approved for HBP + LBBAP | Approved for HBP | Approved for HBP In preparation for LBBAP |
| C315 Delivery System, includes C315-HIS shape | Cleared for various lead implants; often used with HBP and LBBAP. | Approved for various lead implants; often used with HBP and LBBAP. | In preparation |
| SelectSite™ C304 Deflectable Catheter System, and SelectSite™ C304-HIS Deflectable Catheter System | Cleared for various lead implants; often used with HBP. | Approved for various lead implants; often used with HBP. | In preparation |
| Microport | |||
| Pacing lead | — | — | In preparation |
| 3D catheter | — | — | In preparation |
| Alizea/Borea/Celea pacemakers | — | — | In preparation |
Boston Scientific did not provide any information beyond the fact that none of the hardware is currently approved. Readers should consult product technical manuals for update of approved or cleared indications.
CE-MDD, Conformité Européenne Medical Device Directive; FDA, Food and Drug Administration; HBP, His bundle pacing; IDE, investigational device exemption; LBBAP, left bundle branch area pacing; CE-MDR, Conformité Européenne Medical Device Regulation.
Recognition of CSP is progressively being established by international cardiac societies. HBP was introduced in the European Society of Cardiology (ESC) supra-ventricular arrhythmia guidelines in 201912 (for a ‘pace and ablate’ indication) and in the ESC pacing guidelines (in lieu of right ventricular anti-bradycardia pacing and in case of failed CRT implantation) in 2021.13 Recently, the Heart Rhythm Society published a guideline on cardiac physiological pacing which includes indications for HBP and LBBAP along with BVP.14 A European Heart Rhythm Association (EHRA) consensus document was recently published to standardize CSP implantation.15
In this supplementary issue of the journal, the authors overview CSP indications, implantation, and management. In addition, the role of CSP in treating heart failure patients with prolonged PR intervals and atrioventricular ‘dromopathy’ is discussed. A new treatment entity, also covered in this issue, is personalized accelerated physiological pacing which individualizes programming of lower pacing rate according to patient gender and height based on healthy individuals.16 It promises to provide a new treatment strategy for heart failure patients with preserved ejection fraction, although more research is needed. As it may result in an increased percentage of ventricular pacing, CSP is well suited to be coupled with this pacing mode to avoid the untoward effect of ventricular pacing. The entity is also associated with increased rates of atrial pacing. Bachman’s bundle pacing, which aims to mitigate interatrial dyssynchrony, may also be judicious for personalized accelerated physiological pacing as it may avoid atrial tachyarrhythmias associated with right atrial appendage pacing.17 An overview of the implantation technique and the evidence in favour of Bachman’s bundle pacing is revisited in this issue.
Over the past two decades, we have witnessed exciting developments in physiological pacing. By connecting to the patient’s natural conduction system, these new modalities for pacing the heart avoid the detrimental effects of myocardial stimulation and may even correct underlying conduction disease. New frontiers are being explored, which promise to provide innovative solutions for the benefit of our patients.
Contributor Information
Haran Burri, Cardiology Department, Cardiac Pacing Unit, University Hospital of Geneva, Geneva, Switzerland.
Pugazhendhi Vijayaraman, Division of Cardiac Electrophysiology, Geisinger Heart Institute, Geisinger Wyoming Valley Medical Center, 1000 E Mountain blvd, Wilkes-Barre, PA 18711, USA.
Funding
This article and the supplementary issue were funded by Medtronic. This manuscript was published as part of a supplement sponsored by Medtronic. The content was developed independent of the sponsor. Authors did not receive an honorarium.
Data availability
No new data were generated or analysed in support of this research.
References
- 1. Shimony A, Eisenberg MJ, Filion KB, Amit G. Beneficial effects of right ventricular non-apical vs. apical pacing: a systematic review and meta-analysis of randomized-controlled trials. Europace 2012;14:81–91. [DOI] [PubMed] [Google Scholar]
- 2. Yu C-M, Chan JY-S, Zhang Q, Omar R, Yip GW-K, Hussin Aet al. Biventricular pacing in patients with bradycardia and normal ejection fraction. N Engl J Med 2009;361:2123–2134. [DOI] [PubMed] [Google Scholar]
- 3. Scherlag BJ, Kosowsky BD, Damato AN. A technique for ventricular pacing from the His bundle of the intact heart. J Appl Physiol 1967;22:584–587. [DOI] [PubMed] [Google Scholar]
- 4. Narula OS, Scherlag BJ, Samet P. Pervenous pacing of the specialized conducting system in man. His bundle and A-V nodal stimulation. Circulation 1970;41:77–87. [DOI] [PubMed] [Google Scholar]
- 5. Deshmukh P, Casavant DA, Romanyshyn M, Anderson K. Permanent, direct His-bundle pacing: a novel approach to cardiac pacing in patients with normal His-Purkinje activation. Circulation 2000;101:869–877. [DOI] [PubMed] [Google Scholar]
- 6. Zanon F, Ellenbogen KA, Dandamudi G, Sharma PS, Huang W, Lustgarten DLet al. Permanent His-bundle pacing: a systematic literature review and meta-analysis. Europace 2018;20:1819–1826. [DOI] [PubMed] [Google Scholar]
- 7. Beer D, Dandamudi G, Mandrola JM, Friedman PA, Vijayaraman P. His-bundle pacing: impact of social media. Europace 2019;21:1445–1450. [DOI] [PubMed] [Google Scholar]
- 8. Mafi-Rad M, Luermans JG, Blaauw Y, Janssen M, Crijns HJ, Prinzen FWet al. Feasibility and acute hemodynamic effect of left ventricular septal pacing by transvenous approach through the interventricular septum. Circ Arrhythm Electrophysiol 2016;9:e003344. [DOI] [PubMed] [Google Scholar]
- 9. Huang W, Su L, Wu S, Xu L, Xiao F, Zhou Xet al. A novel pacing strategy with low and stable output: pacing the left bundle branch immediately beyond the conduction block. Can J Cardiol 2017;33:1736.e1–1736.e3. [DOI] [PubMed] [Google Scholar]
- 10. Kircanski B, Boveda S, Prinzen F, Sorgente A, Anic A, Conte Get al. Conduction system pacing in everyday clinical practice: EHRA physician survey. Europace 2023;25:682–687. [DOI] [PMC free article] [PubMed] [Google Scholar]
- 11. Keene D, Anselme F, Burri H, Pérez ÓC, Čurila K, Derndorfer Met al. Conduction system pacing, a European survey: insights from clinical practice. EP Europace 2023;25:euad019. [DOI] [PMC free article] [PubMed] [Google Scholar]
- 12. Brugada J, Katritsis DG, Arbelo E, Arribas F, Bax JJ, Blomstrom-Lundqvist Cet al. 2019 ESC guidelines for the management of patients with supraventricular tachycardia. The task force for the management of patients with supraventricular tachycardia of the European Society of Cardiology (ESC). Eur Heart J 2020;41:655–720. [DOI] [PubMed] [Google Scholar]
- 13. Glikson M, Nielsen JC, Kronborg MB, Michowitz Y, Auricchio A, Barbash IMet al. 2021 ESC guidelines on cardiac pacing and cardiac resynchronization therapy. Europace 2022;24:71–164. [DOI] [PMC free article] [PubMed] [Google Scholar]
- 14. Chung MK, Patton KK, Lau CP, Dal Forno ARJ, Al-Khatib SM, Arora Vet al. 2023 HRS/APHRS/LAHRS guideline on cardiac physiologic pacing for the avoidance and mitigation of heart failure. Heart Rhythm 2023;20:e17–e91. [DOI] [PMC free article] [PubMed] [Google Scholar]
- 15. Burri H, Jastrzebski M, Cano Ó, Čurila K, de Pooter J, Huang Wet al. EHRA Clinical consensus statement on conduction system pacing implantation: endorsed by the Asia Pacific Heart Rhythm Society (APHRS), Canadian Heart Rhythm Society (CHRS), and Latin American Heart Rhythm Society (LAHRS). Europace 2023;25:1208–1236. [DOI] [PMC free article] [PubMed] [Google Scholar]
- 16. Infeld M, Wahlberg K, Cicero J, Plante TB, Meagher S, Novelli Aet al. Effect of personalized accelerated pacing on quality of life, physical activity, and atrial fibrillation in patients with preclinical and overt heart failure with preserved ejection fraction: the myPACE randomized clinical trial. JAMA Cardiol 2023;8:213–221. [DOI] [PMC free article] [PubMed] [Google Scholar]
- 17. Infeld M, Nicoli CD, Meagher S, Tompkins BJ, Wayne S, Irvine Bet al. Clinical impact of Bachmann’s bundle pacing defined by electrocardiographic criteria on atrial arrhythmia outcomes. Europace 2022;24:1460–1468. [DOI] [PubMed] [Google Scholar]
Associated Data
This section collects any data citations, data availability statements, or supplementary materials included in this article.
Data Availability Statement
No new data were generated or analysed in support of this research.