Single Lead Implantable Cardioverter Defibrillator (ICD) with a Floating Atrial Dipole: A Systematic Review and Non-Comparative Meta-Analysis
Main Article Content
Abstract
Background: A DX implantable cardioverter defibrillator (ICD) system consists of an ICD and a shock lead equipped with two ring electrodes positioned in the atrium, referred to as the DX-lead. This system allows the collection of atrial signals using a single lead. Multiple studies on the device have been conducted over more than a decade.
Aims: The aim of this study is to summarise these data in a non-comparative meta-analysis.
Methods: A systematic literature review targeting publications on studies including a certain type of ICD, VR-DX ICD, was conducted. Subsequently a meta-analysis of proportions was conducted. Endpoints selected for evaluation included p-wave amplitude (at day 0, <6 months, 6-12 months and >12 months), appropriate and inappropriate shock rates, and all-cause mortality.
Results: One randomised controlled trial, 11 prospective cohort studies and registries, and two retrospective studies were selected for analysis. P-wave amplitudes were consistently in a range where they can support clinical decision making across studies and remained stable over a follow-up of up to two years. Pooled shock incidence was consistent with industry standard for appropriate (10.7%) and inappropriate shocks (2.4%) across studies. All-cause mortality was at an average of 5%, increasing, as expected, with duration of study follow-up. Like shock results, mortality was within the expected range.
Conclusion: This analysis shows that the VR-DX ICD system works reliably and provides an added benefit compared to single chamber ICD in the form of atrial sensing. Atrial view without requiring a second lead provides clinicians with an attractive, hardware-sparing option for the continuous monitoring of atrial activity.
Keywords:
DX ICD, implantable cardioverter defibrillator, atrial fibrillation, atrial burden monitoring, atrial dipole
Article Details
How to Cite
FREITAG, Andreas et al.
Single Lead Implantable Cardioverter Defibrillator (ICD) with a Floating Atrial Dipole: A Systematic Review and Non-Comparative Meta-Analysis.
Medical Research Archives, [S.l.], v. 11, n. 8, aug. 2023.
ISSN 2375-1924.
Available at: <https://esmed.org/MRA/mra/article/view/4326>. Date accessed: 13 may 2024.
doi: https://doi.org/10.18103/mra.v11i8.4326.
Section
Review Articles
The Medical Research Archives grants authors the right to publish and reproduce the unrevised contribution in whole or in part at any time and in any form for any scholarly non-commercial purpose with the condition that all publications of the contribution include a full citation to the journal as published by the Medical Research Archives.
References
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2. Dewland TA, Pellegrini CN, Wang Y, Marcus GM, Keung E, Varosy PD. Dual-chamber implantable cardioverter-defibrillator selection is associated with increased complication rates and mortality among patients enrolled in the NCDR implantable cardioverter-defibrillator registry. Journal of the American College of Cardiology. 2011;58(10):1007-1013. doi:10.1016/j.jacc.2011.04.039.
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11. Schuchert A, Niehaus M, Binner L, Belke R, Meinertz T. Feasibility of Atrial Sensing Via a Free-Floating Single-Pass Defibrillation Lead for Dual-Chamber Defibrillators. Journal of Interventional Cardiac Electrophysiology. 2003;8:209-214.
12. Sticherling C, Zabel M, Spencker S, et al. Comparison of a novel, single-lead atrial sensing system with a dual-chamber implantable cardioverter-defibrillator system in patients without antibradycardia pacing indications: Results of a randomized study. Circ Arrhythm Electrophysiol. 2011;4(1):56-63. doi:10.1161/CIRCEP.110.958397.
13. Stazi F, Mampieri M, Cardinale M, Laudadio MT, Gargaro A, Del Giudice GB. Implant and long-term evaluation of atrial signal amplification in a single-lead ICD. Pacing Clin Electrophysiol. 2012;35(9):1119-1125. doi:10.1111/j.1540-8159.2012.03452.x.
14. Safak E, Schmitz D, Konorza T, Wende C, Ros JO de, Schirdewan A. Clinical efficacy and safety of an implantable cardioverter-defibrillator lead with a floating atrial sensing dipole. Pacing Clin Electrophysiol. 2013;36(8):952-962. doi:10.1111/pace.12171.
15. Iori M, Giacopelli D, Quartieri F, Bottoni N, Manari A. Implantable cardioverter defibrillator system with floating atrial sensing dipole: A single-center experience. Pacing Clin Electrophysiol. 2014;37(10):1265-1273. doi:10.1111/pace.12421.
16. Biffi M, Massaro G, Candelora A, et al. Less is more: Can we achieve cardiac resynchronization with 2 leads only? Int J Cardiol. 2017;249:184-190. doi:10.1016/j.ijcard.2017.09.189.
17. Michalak M, Cacko A, Kapłon-Cieślicka A, et al. Influence of echocardiographic and radiographic characteristics on atrial sensing amplitude in patients with Linox Smart S DX defibrillation leads. Cardiol J. 2017;24(6):671-676. doi:10.5603/CJ.a2016.0095.
18. Kurt M, Jathanna N, Babady M, et al. Avoiding inappropriate therapy of single-lead implantable cardioverter-defibrillator by using atrial-sensing electrodes. J Cardiovasc Electrophysiol. 2018;29(12):1682-1689. doi:10.1111/jce.13736.
19. Safak E, D'Ancona G, Kaplan H, et al. New generation cardioverter-defibrillator lead with a floating atrial sensing dipole: Long-term performance. Pacing Clin Electrophysiol. 2018;41(2):128-135. doi:10.1111/pace.13256.
20. Thomas G, Choi DY, Doppalapudi H, et al. Subclinical atrial fibrillation detection with a floating atrial sensing dipole in single lead implantable cardioverter-defibrillator systems: Results of the SENSE trial. J Cardiovasc Electrophysiol. 2019;30(10):1994-2001. doi:10.1111/jce.14081.
21. Biffi M, Iori M, Maria E de, et al. The role of atrial sensing for new-onset atrial arrhythmias diagnosis and management in single-chamber implantable cardioverter-defibrillator recipients: Results from the THINGS registry. J Cardiovasc Electrophysiol. 2020;31(4):846-853. doi:10.1111/jce.14396.
22. Marai I, Milman A, Diamante R, et al. The efficacy of the LinoxSmart DX ICD lead from a single center experience. Indian Pacing Electrophysiol J. 2020;20(4):137-140. doi:10.1016/j.ipej.2019.12.014.
23. Shaik NA, Drucker M, Pierce C, et al. Novel two-lead cardiac resynchronization therapy system provides equivalent CRT responses with less complications than a conventional three-lead system: Results from the QP ExCELs lead registry. J Cardiovasc Electrophysiol. 2020;31(7):1784-1792. doi:10.1111/jce.14552.
24. Gwag HB, Lee SH, Kim JS, et al. Long-term evaluation of sensing variability of a floating atrial dipole in a single‑lead defibrillator: The mechanistic basis of long-term stability of amplified atrial electrogram. Int J Cardiol. 2021;336:67-72. doi:10.1016/j.ijcard.2021.05.024.
25. BIOTRONIK: MATRIX (Management and Detection of Atrial Tachyarrhythmias in Patients Implanted With BIOTRONIK DX Systems) Study - Clinical Investigation Report (NCT 01774357). 2019.
26. Page MJ, McKenzie JE, Bossuyt PM, et al. The PRISMA 2020 statement: An updated guideline for reporting systematic reviews. BMJ. 2021;372:n71. doi:10.1136/bmj.n71.
27. Pung X, Hong DZ, Ho TY, et al. The utilization of atrial sensing dipole in single lead implantable cardioverter defibrillator for detection of new‐onset atrial high‐rate episodes or subclinical atrial fibrillation: A systematic review and meta‐analysis. J Arrhythm. 2022;36(41):2793. doi:10.1002/joa3.12675.
28. Boriani G, Glotzer TV, Santini M, et al. Device-detected atrial fibrillation and risk for stroke: An analysis of 10,000 patients from the SOS AF project (Stroke preventiOn Strategies based on Atrial Fibrillation information from implanted devices). European Heart Journal. 2014;35(8):508-516. doi:10.1093/eurheartj/eht491.
29. Hindricks G, Potpara T, Dagres N, et al. 2020 ESC Guidelines for the diagnosis and management of atrial fibrillation developed in collaboration with the European Association for Cardio-Thoracic Surgery (EACTS): The Task Force for the diagnosis and management of atrial fibrillation of the European Society of Cardiology (ESC) Developed with the special contribution of the European Heart Rhythm Association (EHRA) of the ESC. European Heart Journal. 2021;42(5):373-498. doi:10.1093/eurheartj/ehaa612.
30. Hindricks G, Varma N, Kacet S, et al. Daily remote monitoring of implantable cardioverter-defibrillators: Insights from the pooled patient-level data from three randomized controlled trials (IN-TIME, ECOST, TRUST). European Heart Journal. 2017;38(22):1749-1755. doi:10.1093/eurheartj/ehx015.
31. Bardy Gust H., Lee Kerry L., Mark Daniel B., et al. Amiodarone or an Implantable Cardioverter–Defibrillator for Congestive Heart Failure.
32. Zabel M, Willems R, Lubinski A, et al. Clinical effectiveness of primary prevention implantable cardioverter-defibrillators: Results of the EU-CERT-ICD controlled multicentre cohort study. European Heart Journal. 2020;41(36):3437-3447. doi:10.1093/eurheartj/ehaa226.
33. Zeitler EP, Sanders GD, Singh K, et al. Single vs. dual chamber implantable cardioverter-defibrillators or programming of implantable cardioverter-defibrillators in patients without a bradycardia pacing indication: Systematic review and meta-analysis. Europace. 2018;20(10):1621-1629. doi:10.1093/europace/euy183.
34. Statuto G, Paolisso P, Massaro G, et al., eds. Atrial fibrillation and single chamber ICDS: implications of atrial signal availability. European Heart Journal Supplements; 2019; 21.
35. Carrington M, Silveiro Antonio P, Nunes-Ferreira A, et al. It is possible to predict mortality after ICD implantation? European Heart Journal. 2021;42(1). https://doi.org/10.1093/eurheartj/ehab724.0648.
36. Schnabel RB, Pecen L, Ojeda FM, et al. Gender differences in clinical presentation and 1-year outcomes in atrial fibrillation. Heart. 2017;103(13):1024-1030. doi:10.1136/heartjnl-2016-310406.
37. Andersson T, Magnuson A, Bryngelsson I-L, et al. All-cause mortality in 272,186 patients hospitalized with incident atrial fibrillation 1995-2008: A Swedish nationwide long-term case-control study. European Heart Journal. 2013;34(14):1061-1067. doi:10.1093/eurheartj/ehs469.
38. Kirchhof P, Camm AJ, Goette A, et al. Early Rhythm-Control Therapy in Patients with Atrial Fibrillation. N Engl J Med. 2020;383(14):1305-1316. doi:10.1056/NEJMoa2019422.
39. van Barreveld M, Verstraelen TE, van Dessel PFHM, et al. Dutch Outcome in Implantable Cardioverter-Defibrillator Therapy: Implantable Cardioverter-Defibrillator-Related Complications in a Contemporary Primary Prevention Cohort. J Am Heart Assoc. 2021;10(7):e018063. doi:10.1161/JAHA.120.018063.
40. Borne RT, Varosy P, Lan Z, et al. Trends in Use of Single- vs Dual-Chamber Implantable Cardioverter-Defibrillators Among Patients Without a Pacing Indication, 2010-2018. JAMA Netw Open. 2022;5(3):e223429-e223429. doi:10.1001/jamanetworkopen.2022.3429.
41. Vamos M, Nemeth M, Balazs T, Zima E, Duray GZ. Rationale and feasibility of the atrioventricular single-lead ICD systems with a floating atrial dipole (DX) in clinical practice. Trends Cardiovasc Med. 2021. doi:10.1016/j.tcm.2021.01.003.
42. Neugebauer EAM, Rath A, Antoine S-L, et al. Specific barriers to the conduct of randomised clinical trials on medical devices. Trials. 2017;18(1):427. doi:10.1186/s13063-017-2168-0.
2. Dewland TA, Pellegrini CN, Wang Y, Marcus GM, Keung E, Varosy PD. Dual-chamber implantable cardioverter-defibrillator selection is associated with increased complication rates and mortality among patients enrolled in the NCDR implantable cardioverter-defibrillator registry. Journal of the American College of Cardiology. 2011;58(10):1007-1013. doi:10.1016/j.jacc.2011.04.039.
3. Linde C, Bongiorni MG, Birgersdotter-Green U, et al. Sex differences in cardiac arrhythmia: A consensus document of the European Heart Rhythm Association, endorsed by the Heart Rhythm Society and Asia Pacific Heart Rhythm Society. Europace. 2018;20(10):1565-1565ao. doi:10.1093/europace/euy067.
4. Hindricks G, Potpara T, Dagres N, et al. 2020 ESC Guidelines for the diagnosis and management of atrial fibrillation developed in collaboration with the European Association for Cardio-Thoracic Surgery (EACTS): The Task Force for the diagnosis and management of atrial fibrillation of the European Society of Cardiology (ESC) Developed with the special contribution of the European Heart Rhythm Association (EHRA) of the ESC. European Heart Journal. 2021;42(5):373-498. doi:10.1093/eurheartj/ehaa612.
5. Xie Y, Xu E, Bowe B, Al-Aly Z. Long-term cardiovascular outcomes of COVID-19. Nature Medicine. 2022;28(3):583-590. doi:10.1038/s41591-022-01689-3.
6. Worden NE, Alqasrawi M, Mazur A. Long-Term Stability and Clinical Utility of Amplified Atrial Electrograms in a Single-Lead ICD System with Floating Atrial Electrodes. Pacing Clin Electrophysiol. 2016;39(12):1327-1334. doi:10.1111/pace.12967.
7. Hong QN, Fàbregues S, Bartlett G, et al. The Mixed Methods Appraisal Tool (MMAT) version 2018 for information professionals and researchers. EFI. 2018;34(4):285-291. doi:10.3233/EFI-180221.
8. Higgins JPT, Thomas J, Chandler J, et al., eds. Cochrane Handbook for Systematic Reviews of Interventions. [Version 6.3 (updated February 2022)]: Cochrane; 2022. www.training.cochrane.org/handbook.
9. DerSimonian R, Laird N. Meta-analysis in clinical trials. Control Clin Trials. 1986;7(3):177-188. doi:10.1016/0197-2456(86)90046-2.
10. Niehaus M, Sousa M de, Klein G, et al. Chronic Experiences with a Single Lead Dual Chamber Implantable Cardioverter Defibrillator System. Pacing Clin Electrophysiol. 2003;26:1937-1943.
11. Schuchert A, Niehaus M, Binner L, Belke R, Meinertz T. Feasibility of Atrial Sensing Via a Free-Floating Single-Pass Defibrillation Lead for Dual-Chamber Defibrillators. Journal of Interventional Cardiac Electrophysiology. 2003;8:209-214.
12. Sticherling C, Zabel M, Spencker S, et al. Comparison of a novel, single-lead atrial sensing system with a dual-chamber implantable cardioverter-defibrillator system in patients without antibradycardia pacing indications: Results of a randomized study. Circ Arrhythm Electrophysiol. 2011;4(1):56-63. doi:10.1161/CIRCEP.110.958397.
13. Stazi F, Mampieri M, Cardinale M, Laudadio MT, Gargaro A, Del Giudice GB. Implant and long-term evaluation of atrial signal amplification in a single-lead ICD. Pacing Clin Electrophysiol. 2012;35(9):1119-1125. doi:10.1111/j.1540-8159.2012.03452.x.
14. Safak E, Schmitz D, Konorza T, Wende C, Ros JO de, Schirdewan A. Clinical efficacy and safety of an implantable cardioverter-defibrillator lead with a floating atrial sensing dipole. Pacing Clin Electrophysiol. 2013;36(8):952-962. doi:10.1111/pace.12171.
15. Iori M, Giacopelli D, Quartieri F, Bottoni N, Manari A. Implantable cardioverter defibrillator system with floating atrial sensing dipole: A single-center experience. Pacing Clin Electrophysiol. 2014;37(10):1265-1273. doi:10.1111/pace.12421.
16. Biffi M, Massaro G, Candelora A, et al. Less is more: Can we achieve cardiac resynchronization with 2 leads only? Int J Cardiol. 2017;249:184-190. doi:10.1016/j.ijcard.2017.09.189.
17. Michalak M, Cacko A, Kapłon-Cieślicka A, et al. Influence of echocardiographic and radiographic characteristics on atrial sensing amplitude in patients with Linox Smart S DX defibrillation leads. Cardiol J. 2017;24(6):671-676. doi:10.5603/CJ.a2016.0095.
18. Kurt M, Jathanna N, Babady M, et al. Avoiding inappropriate therapy of single-lead implantable cardioverter-defibrillator by using atrial-sensing electrodes. J Cardiovasc Electrophysiol. 2018;29(12):1682-1689. doi:10.1111/jce.13736.
19. Safak E, D'Ancona G, Kaplan H, et al. New generation cardioverter-defibrillator lead with a floating atrial sensing dipole: Long-term performance. Pacing Clin Electrophysiol. 2018;41(2):128-135. doi:10.1111/pace.13256.
20. Thomas G, Choi DY, Doppalapudi H, et al. Subclinical atrial fibrillation detection with a floating atrial sensing dipole in single lead implantable cardioverter-defibrillator systems: Results of the SENSE trial. J Cardiovasc Electrophysiol. 2019;30(10):1994-2001. doi:10.1111/jce.14081.
21. Biffi M, Iori M, Maria E de, et al. The role of atrial sensing for new-onset atrial arrhythmias diagnosis and management in single-chamber implantable cardioverter-defibrillator recipients: Results from the THINGS registry. J Cardiovasc Electrophysiol. 2020;31(4):846-853. doi:10.1111/jce.14396.
22. Marai I, Milman A, Diamante R, et al. The efficacy of the LinoxSmart DX ICD lead from a single center experience. Indian Pacing Electrophysiol J. 2020;20(4):137-140. doi:10.1016/j.ipej.2019.12.014.
23. Shaik NA, Drucker M, Pierce C, et al. Novel two-lead cardiac resynchronization therapy system provides equivalent CRT responses with less complications than a conventional three-lead system: Results from the QP ExCELs lead registry. J Cardiovasc Electrophysiol. 2020;31(7):1784-1792. doi:10.1111/jce.14552.
24. Gwag HB, Lee SH, Kim JS, et al. Long-term evaluation of sensing variability of a floating atrial dipole in a single‑lead defibrillator: The mechanistic basis of long-term stability of amplified atrial electrogram. Int J Cardiol. 2021;336:67-72. doi:10.1016/j.ijcard.2021.05.024.
25. BIOTRONIK: MATRIX (Management and Detection of Atrial Tachyarrhythmias in Patients Implanted With BIOTRONIK DX Systems) Study - Clinical Investigation Report (NCT 01774357). 2019.
26. Page MJ, McKenzie JE, Bossuyt PM, et al. The PRISMA 2020 statement: An updated guideline for reporting systematic reviews. BMJ. 2021;372:n71. doi:10.1136/bmj.n71.
27. Pung X, Hong DZ, Ho TY, et al. The utilization of atrial sensing dipole in single lead implantable cardioverter defibrillator for detection of new‐onset atrial high‐rate episodes or subclinical atrial fibrillation: A systematic review and meta‐analysis. J Arrhythm. 2022;36(41):2793. doi:10.1002/joa3.12675.
28. Boriani G, Glotzer TV, Santini M, et al. Device-detected atrial fibrillation and risk for stroke: An analysis of 10,000 patients from the SOS AF project (Stroke preventiOn Strategies based on Atrial Fibrillation information from implanted devices). European Heart Journal. 2014;35(8):508-516. doi:10.1093/eurheartj/eht491.
29. Hindricks G, Potpara T, Dagres N, et al. 2020 ESC Guidelines for the diagnosis and management of atrial fibrillation developed in collaboration with the European Association for Cardio-Thoracic Surgery (EACTS): The Task Force for the diagnosis and management of atrial fibrillation of the European Society of Cardiology (ESC) Developed with the special contribution of the European Heart Rhythm Association (EHRA) of the ESC. European Heart Journal. 2021;42(5):373-498. doi:10.1093/eurheartj/ehaa612.
30. Hindricks G, Varma N, Kacet S, et al. Daily remote monitoring of implantable cardioverter-defibrillators: Insights from the pooled patient-level data from three randomized controlled trials (IN-TIME, ECOST, TRUST). European Heart Journal. 2017;38(22):1749-1755. doi:10.1093/eurheartj/ehx015.
31. Bardy Gust H., Lee Kerry L., Mark Daniel B., et al. Amiodarone or an Implantable Cardioverter–Defibrillator for Congestive Heart Failure.
32. Zabel M, Willems R, Lubinski A, et al. Clinical effectiveness of primary prevention implantable cardioverter-defibrillators: Results of the EU-CERT-ICD controlled multicentre cohort study. European Heart Journal. 2020;41(36):3437-3447. doi:10.1093/eurheartj/ehaa226.
33. Zeitler EP, Sanders GD, Singh K, et al. Single vs. dual chamber implantable cardioverter-defibrillators or programming of implantable cardioverter-defibrillators in patients without a bradycardia pacing indication: Systematic review and meta-analysis. Europace. 2018;20(10):1621-1629. doi:10.1093/europace/euy183.
34. Statuto G, Paolisso P, Massaro G, et al., eds. Atrial fibrillation and single chamber ICDS: implications of atrial signal availability. European Heart Journal Supplements; 2019; 21.
35. Carrington M, Silveiro Antonio P, Nunes-Ferreira A, et al. It is possible to predict mortality after ICD implantation? European Heart Journal. 2021;42(1). https://doi.org/10.1093/eurheartj/ehab724.0648.
36. Schnabel RB, Pecen L, Ojeda FM, et al. Gender differences in clinical presentation and 1-year outcomes in atrial fibrillation. Heart. 2017;103(13):1024-1030. doi:10.1136/heartjnl-2016-310406.
37. Andersson T, Magnuson A, Bryngelsson I-L, et al. All-cause mortality in 272,186 patients hospitalized with incident atrial fibrillation 1995-2008: A Swedish nationwide long-term case-control study. European Heart Journal. 2013;34(14):1061-1067. doi:10.1093/eurheartj/ehs469.
38. Kirchhof P, Camm AJ, Goette A, et al. Early Rhythm-Control Therapy in Patients with Atrial Fibrillation. N Engl J Med. 2020;383(14):1305-1316. doi:10.1056/NEJMoa2019422.
39. van Barreveld M, Verstraelen TE, van Dessel PFHM, et al. Dutch Outcome in Implantable Cardioverter-Defibrillator Therapy: Implantable Cardioverter-Defibrillator-Related Complications in a Contemporary Primary Prevention Cohort. J Am Heart Assoc. 2021;10(7):e018063. doi:10.1161/JAHA.120.018063.
40. Borne RT, Varosy P, Lan Z, et al. Trends in Use of Single- vs Dual-Chamber Implantable Cardioverter-Defibrillators Among Patients Without a Pacing Indication, 2010-2018. JAMA Netw Open. 2022;5(3):e223429-e223429. doi:10.1001/jamanetworkopen.2022.3429.
41. Vamos M, Nemeth M, Balazs T, Zima E, Duray GZ. Rationale and feasibility of the atrioventricular single-lead ICD systems with a floating atrial dipole (DX) in clinical practice. Trends Cardiovasc Med. 2021. doi:10.1016/j.tcm.2021.01.003.
42. Neugebauer EAM, Rath A, Antoine S-L, et al. Specific barriers to the conduct of randomised clinical trials on medical devices. Trials. 2017;18(1):427. doi:10.1186/s13063-017-2168-0.