Systematic review of leadless pacemaker

References

• Haydock P, Camm AJ. History and evolution of pacing and devices. Heart. 2022;108(10):794–799. doi:10.1136/heartjnl-2021-320149.
   PubMed Web of Science ®Google Scholar
• Raatikainen MJP, Arnar DO, Merkely B, et al. A decade of information on the use of cardiac implantable electronic devices and interventional electrophysiological procedures in the european society of cardiology countries: 2017 report from the european heart rhythm association. Europace. 2017;19(suppl_2):ii1–ii90. doi:10.1093/europace/eux258.
   PubMed Web of Science ®Google Scholar
• Udo EO, Zuithoff NP, van Hemel NM, et al. Incidence and predictors of short- and long-term complications in pacemaker therapy: the FOLLOWPACE study. Heart Rhythm. 2012;9(5):728–735. doi:10.1016/j.hrthm.2011.12.014.
   PubMed Web of Science ®Google Scholar
• Bencardino G, Scacciavillani R, Narducci ML. Leadless pacemaker technology: clinical evidence of new paradigm of pacing. Rev Cardiovasc Med. 2022;23(2):43. doi:10.31083/j.rcm2302043.
   PubMed Web of Science ®Google Scholar
• Kirkfeldt RE, Johansen JB, Nohr EA, et al. Complications after cardiac implantable electronic device implantations: an analysis of a complete, nationwide cohort in Denmark. Eur Heart J. 2014;35(18):1186–1194. doi:10.1093/eurheartj/eht511.
   PubMed Web of Science ®Google Scholar
• El-Chami MF, Al-Samadi F, Clementy N, et al. Updated performance of the micra transcatheter pacemaker in the real-world setting: a comparison to the investigational study and a transvenous historical control. Heart Rhythm. 2018;15(12):1800–1807. doi:10.1016/j.hrthm.2018.08.005.
   PubMed Web of Science ®Google Scholar
• Reddy VY, Exner DV, Cantillon DJ, et al. Percutaneous implantation of an entirely intracardiac leadless pacemaker. N Engl J Med. 2015;373(12):1125–1135. doi:10.1056/NEJMoa1507192.
   PubMed Web of Science ®Google Scholar
• Reynolds D, Duray GZ, Omar R, et al. A leadless intracardiac transcatheter pacing system. N Engl J Med. 2016;374(6):533–541. doi:10.1056/NEJMoa1511643.
   PubMed Web of Science ®Google Scholar
• El-Chami MF, Roberts PR, Kypta A, et al. How to implant a leadless pacemaker with a tine-based fixation. J Cardiovasc Electrophysiol. 2016;27(12):1495–1501. doi:10.1111/jce.13092.
   PubMed Web of Science ®Google Scholar
• Defaye P, Biffi M, El-Chami M, et al. Cardiac pacing and lead devices management: 25 years of research at EP europace journal. Europace. 2023;25(8):euad202. doi:10.1093/europace/euad202.
   PubMed Web of Science ®Google Scholar
• Reddy VY, Neuzil P, Booth DF, et al. Dual-chamber leadless pacing: atrioventricular synchrony in preclinical models of normal or blocked atrioventricular conduction. Heart Rhythm. 2023;20(8):1146–1155.
   PubMed Web of Science ®Google Scholar
• Cantillon DJ, Gambhir A, Banker R, et al. Wireless communication between paired leadless pacemakers for Dual-Chamber synchrony. Circ Arrhythm Electrophysiol. 2022;15(7):e010909.
   PubMed Web of Science ®Google Scholar
• Knops RE, Reddy VY, Ip JE, et al. A Dual-Chamber leadless pacemaker. N Engl J Med. 2023;388(25):2360–2370. doi:10.1056/NEJMoa2300080.
   PubMed Web of Science ®Google Scholar
• Duray GZ, Ritter P, El-Chami M, et al. Long-term performance of a transcatheter pacing system: 12-month results from the micra transcatheter pacing study. Heart Rhythm. 2017;14(5):702–709. doi:10.1016/j.hrthm.2017.01.035.
   PubMed Web of Science ®Google Scholar
• Reddy VY, Knops RE, Sperzel J, et al. Permanent leadless cardiac pacing: results of the LEADLESS trial. Circulation. 2014;129(14):1466–1471. doi:10.1161/CIRCULATIONAHA.113.006987.
   PubMed Web of Science ®Google Scholar
• Sperzel J, Defaye P, Delnoy P, et al. Primary safety results from the LEADLESS observational study. Europace. 2018;20(9):1491–1497. doi:10.1093/europace/eux359.
   PubMed Web of Science ®Google Scholar
• Roberts PR, Clementy N, Al Samadi F, et al. A leadless pacemaker in the real-world setting: the micra transcatheter pacing system Post-Approval registry. Heart Rhythm. 2017;14(9):1375–1379. doi:10.1016/j.hrthm.2017.05.017.
   PubMed Web of Science ®Google Scholar
• Piccini JP, El-Chami M, Wherry K, et al. Contemporaneous comparison of outcomes among patients implanted with a leadless vs transvenous Single-Chamber ventricular pacemaker. JAMA Cardiol. 2021;6(10):1187–1195. doi:10.1001/jamacardio.2021.2621.
   PubMed Web of Science ®Google Scholar
• El-Chami MF, Bockstedt L, Longacre C, et al. Leadless vs. transvenous single-chamber ventricular pacing in the micra CED study: 2-year follow-up. Eur Heart J. 2022;43(12):1207–1215. doi:10.1093/eurheartj/ehab767.
   PubMed Web of Science ®Google Scholar
• Pagan E, Gabriels J, Khodak A, et al. Safety of leadless pacemaker implantation in the very elderly. Heart Rhythm. 2020;17(12):2023–2028. doi:10.1016/j.hrthm.2020.05.022.
   PubMed Web of Science ®Google Scholar
• Marschall A, Del Castillo Carnevali H, Torres Lopez M, et al. Leadless pacemaker for urgent permanent implantation in elderly and very elderly patients. J Cardiovasc Med. 2022;23(1):e27–e29. doi:10.2459/JCM.0000000000001257.
   Google Scholar
• Schiavone M, Filtz A, Gasperetti A, et al. Leadless pacemaker implantation in the emergency bradyarrhythmia setting: results from a multicenter european registry. Medicina. 2022;59(1):67. doi:10.3390/medicina59010067.
   PubMed Web of Science ®Google Scholar
• Strik M, Clementy N, Mondoly P, et al. Implantation of a leadless pacemaker in young adults. J Cardiovasc Electrophysiol. 2023;34(2):412–417. doi:10.1111/jce.15796.
   PubMed Web of Science ®Google Scholar
• Zucchelli G, Barletta V, Della Tommasina V, et al. Micra pacemaker implant after cardiac implantable electronic device extraction: feasibility and long-term outcomes. Europace. 2019;21(8):1229–1236. doi:10.1093/europace/euz160.
   PubMed Web of Science ®Google Scholar
• Zucchelli G, Tolve S, Barletta V, et al. Comparison between leadless and transvenous single-chamber pacemaker therapy in a referral Centre for lead extraction. J Interv Card Electrophysiol. 2021;61(2):395–404. doi:10.1007/s10840-020-00832-9.
   PubMed Web of Science ®Google Scholar
• Boveda S, Higuera L, Longacre C, et al. Two-year outcomes of leadless vs. transvenous single-chamber ventricular pacemaker in high-risk subgroups. Europace. 2023;25(3):1041–1050. doi:10.1093/europace/euad016.
   PubMed Web of Science ®Google Scholar
• Hauser RG, Hayes DL, Kallinen LM, et al. Clinical experience with pacemaker pulse generators and transvenous leads: an 8-year prospective multicenter study. Heart Rhythm. 2007;4(2):154–160. doi:10.1016/j.hrthm.2006.10.009.
   PubMed Web of Science ®Google Scholar
• Tokavanich N, Machado C, Banga S, et al. Implant efficiency and clinical performance of aveir™ VR and micra™ VR leadless pacemaker: a multicenter comparative analysis of 67 patients. Pacing Clin Electrophysiol. 2023;46(8):827–832. doi:10.1111/pace.14766.
   PubMed Web of Science ®Google Scholar
• Bari Z, Vamos M, Bogyi P, et al. Physical activity detection in patients with intracardiac leadless pacemaker. J Cardiovasc Electrophysiol. 2018;29(12):1690–1696. doi:10.1111/jce.13729.
   PubMed Web of Science ®Google Scholar
• Grubman E, Ritter P, Ellis CR, et al. To retrieve, or not to retrieve: system revisions with the micra transcatheter pacemaker. Heart Rhythm. 2017;14(12):1801–1806. doi:10.1016/j.hrthm.2017.07.015.
   PubMed Web of Science ®Google Scholar
• Dar T, Akella K, Murtaza G, et al. Comparison of the safety and efficacy of nanostim and micra transcatheter leadless pacemaker (LP) extractions: a multicenter experience. J Interv Card Electrophysiol. 2020;57(1):133–140. doi:10.1007/s10840-019-00684-y.
   PubMed Web of Science ®Google Scholar
• Omdahl P, Eggen MD, Bonner MD, et al. Right ventricular anatomy can accommodate multiple micra transcatheter pacemakers. Pacing Clin Electrophysiol. 2016;39(4):393–397. doi:10.1111/pace.12804.
   PubMed Web of Science ®Google Scholar
• Kalin R, Stanton MS. Current clinical issues for MRI scanning of pacemaker and defibrillator patients. Pacing Clin Electrophysiol. 2005;28(4):326–328. doi:10.1111/j.1540-8159.2005.50024.x.
   PubMed Web of Science ®Google Scholar
• Ahmed FZ, Morris GM, Allen S, et al. Not all pacemakers are created equal: MRI conditional pacemaker and lead technology. J Cardiovasc Electrophysiol. 2013;24(9):1059–1065. doi:10.1111/jce.12238.
   PubMed Web of Science ®Google Scholar
• Soejima K, Edmonson J, Ellingson ML, et al. Safety evaluation of a leadless transcatheter pacemaker for magnetic resonance imaging use. Heart Rhythm. 2016;13(10):2056–2063. doi:10.1016/j.hrthm.2016.06.032.
   PubMed Web of Science ®Google Scholar
• Blessberger H, Kiblboeck D, Reiter C, et al. Monocenter investigation micra ® MRI study (MIMICRY): feasibility study of the magnetic resonance imaging compatibility of a leadless pacemaker system. Europace. 2019;21(1):137–141. doi:10.1093/europace/euy143.
   PubMed Web of Science ®Google Scholar
• Kypta A, Blessberger H, Kiblboeck D, et al. Three tesla cardiac magnetic resonance imaging in a patient with a leadless cardiac pacemaker system. Eur Heart J. 2017;38(34):2628–2628. doi:10.1093/eurheartj/ehx013.
   PubMed Web of Science ®Google Scholar
• Lamas GA, Ellenbogen KA. Evidence base for pacemaker mode selection: from physiology to randomized trials. Circulation. 2004;109(4):443–451. doi:10.1161/01.CIR.0000115642.05037.0E.
   PubMed Web of Science ®Google Scholar
• Kusumoto FM, Schoenfeld MH, Barrett C, et al. ACC/AHA/HRS guideline on the evaluation and management of patients with bradycardia and cardiac conduction delay: a report of the American college of cardiology/American heart association task force on clinical practice guidelines and the heart rhythm society. Circulation. 2018;140:e382–e482.
   PubMed Web of Science ®Google Scholar
• Steinwender C, Khelae SK, Garweg C, et al. Atrioventricular synchronous pacing using a leadless ventricular pacemaker: results from the MARVEL 2 study. JACC Clin Electrophysiol. 2020;6(1):94–106. doi:10.1016/j.jacep.2019.10.017.
   PubMedGoogle Scholar
• Mitacchione G, Schiavone M, Gasperetti A, et al. Atrioventricular synchronous leadless pacemaker: state of art and broadened indications. Rev Cardiovasc Med. 2021;22(2):395–401. doi:10.31083/j.rcm2202045.
   PubMed Web of Science ®Google Scholar
• Chinitz L, Ritter P, Khelae SK, et al. Accelerometer-based atrioventricular synchronous pacing with a ventricular leadless pacemaker: results from the micra atrioventricular feasibility studies. Heart Rhythm. 2018;15(9):1363–1371. doi:10.1016/j.hrthm.2018.05.004.
   PubMed Web of Science ®Google Scholar
• Neugebauer F, Noti F, van Gool S, et al. Leadless atrioventricular synchronous pacing in an outpatient setting: early lessons learned on factors affecting atrioventricular synchrony. Heart Rhythm. 2022;19(5):748–756. doi:10.1016/j.hrthm.2021.12.025.
   PubMed Web of Science ®Google Scholar
• Palmisano P, Guido A, Panico V, et al. Leadless pacemaker versus transvenous single-chamber pacemaker therapy: peri-procedural aspects, utilization of medical resources and patient acceptance. Expert Rev Med Devices. 2021;18(5):483–491. doi:10.1080/17434440.2021.1921573.
   PubMed Web of Science ®Google Scholar
• Cabanas-Grandío P, García Campo E, Bisbal F, et al. Quality of life of patients undergoing conventional vs leadless pacemaker implantation: a multicenter observational study. J Cardiovasc Electrophysiol. 2020;31(1):330–336. doi:10.1111/jce.14322.
   PubMed Web of Science ®Google Scholar
• Tjong FVY, Beurskens NEG, de Groot JR, et al. Health-related quality of life impact of a transcatheter pacing system. J Cardiovasc Electrophysiol. 2018;29(12):1697–1704. doi:10.1111/jce.13726.
   PubMed Web of Science ®Google Scholar
• Gulletta S, Schiavone M, Gasperetti A, et al. Peri-procedural and mid-term follow-up age-related differences in leadless pacemaker implantation: insights from a multicenter european registry. Int J Cardiol. 2023;371:197–203. doi:10.1016/j.ijcard.2022.09.026.
   PubMed Web of Science ®Google Scholar
• Palmisano P, Facchin D, Ziacchi M, et al. Rate and nature of complications with leadless transcatheter pacemakers compared with transvenous pacemakers: results from an italian multicentre large population analysis. Europace. 2023;25(1):112–120. doi:10.1093/europace/euac112.
   PubMed Web of Science ®Google Scholar
• Kypta A, Blessberger H, Lichtenauer M, et al. Complete encapsulation of a leadless cardiac pacemaker. Clin Res Cardiol. 2016;105(1):94–94. doi:10.1007/s00392-015-0929-x.
   PubMed Web of Science ®Google Scholar
• Garg J, Shah K, Bhardwaj R, et al. Adverse events associated with AveirTM VR leadless pacemaker: a food and drug administration MAUDE database study. J Cardiovasc Electrophysiol. 2023; Jun34(6):1469–1471. doi:10.1111/jce.15932.
   PubMed Web of Science ®Google Scholar
• Piccini JP, Stromberg K, Jackson KP, et al. Long-term outcomes in leadless micra transcatheter pacemakers with elevated thresholds at implantation: results from the micra transcatheter pacing system global clinical trial. Heart Rhythm. 2017;14(5):685–691. doi:10.1016/j.hrthm.2017.01.026.
   PubMed Web of Science ®Google Scholar
• Boveda S, Lenarczyk R, Haugaa KH, et al. Use of leadless pacemakers in Europe: results of the european heart rhythm association survey. Europace. 2018;20(3):555–559. doi:10.1093/europace/eux381.
   PubMed Web of Science ®Google Scholar
• Grabowski M, Michalak M, Gawałko M, et al. Implantation of the micra transcatheter pacing system: single polish center experience with the real costs of hospitalization analysis. Cardiol J. 2020;27(1):47–53. doi:10.5603/CJ.a2018.0075.
   PubMed Web of Science ®Google Scholar
• Sinha SK, Sivasambu B, Yenokyan G, et al. Worldwide pacemaker and defibrillator reuse: systematic review and meta-analysis of contemporary trials. Pacing Clin Electrophysiol. 2018;41(11):1500–1507. doi:10.1111/pace.13488.
   PubMed Web of Science ®Google Scholar
• Shen EN, Ishihara CH, Uehara DR. Leadless pacemaker: report of the first experience in hawai‘i. Hawaii J Med Public Health. 2018;77:79–82.
   PubMedGoogle Scholar
• Auricchio A, Delnoy PP, Regoli F, et al. First-in-man implantation of leadless ultrasound-based cardiac stimulation pacing system: novel endocardial left ventricular resynchronization therapy in heart failure patients. Europace. 2013;15(8):1191–1197. doi:10.1093/europace/eut124.
   PubMed Web of Science ®Google Scholar
• Leon AR, Abraham WT, Curtis AB, et al. Safety of transvenous cardiac resynchronization system implantation in patients with chronic heart failure: combined results of over 2,000 patients from a multicenter study program. J Am Coll Cardiol. 2005;46(12):2348–2356. doi:10.1016/j.jacc.2005.08.031.
   PubMed Web of Science ®Google Scholar
• Hummel JD, Coppess MA, Osborn JS, et al. Real-world assessment of acute left ventricular lead implant success and complication rates: results from the attain success clinical trial. Pacing Clin Electrophysiol. 2016;39(11):1246–1253. doi:10.1111/pace.12939.
   PubMed Web of Science ®Google Scholar
• Sieniewicz BJ, Gould J, Porter B, et al. Understanding non-response to cardiac resynchronisation therapy: common problems and potential solutions. Heart Fail Rev. 2019;24(1):41–54. doi:10.1007/s10741-018-9734-8.
   PubMed Web of Science ®Google Scholar
• Auricchio A, Delnoy PP, Butter C, et al. Feasibility, safety, and short-term outcome of leadless ultrasound-based endocardial left ventricular resynchronization in heart failure patients: results of the wireless stimulation endocardially for CRT (WiSE-CRT) study. Europace. 2014;16(5):681–688. doi:10.1093/europace/eut435.
   PubMed Web of Science ®Google Scholar
• Okabe T, Hummel JD, Bank AJ, et al. Leadless left ventricular stimulation with WiSE-CRT System-Initial experience and results from phase I of SOLVE-CRT study (nonrandomized, roll-in phase). Heart Rhythm. 2022;19(1):22–29. doi:10.1016/j.hrthm.2021.06.1195.
   PubMed Web of Science ®Google Scholar
• Elliott MK, Vergara P, Wijesuriya N, et al. Feasibility of leadless left ventricular septal pacing with the WiSE-CRT system to target the left bundle branch area: a porcine model and multicenter patient experience. Heart Rhythm. 2022;19(12):1974–1983. doi:10.1016/j.hrthm.2022.07.017.
   PubMed Web of Science ®Google Scholar
• Reddy VY, Miller MA, Neuzil P, et al. Cardiac resynchronization therapy with wireless left ventricular endocardial pacing: the SELECT-LV study. J Am Coll Cardiol. 2017;69(17):2119–2129. doi:10.1016/j.jacc.2017.02.059.
   PubMed Web of Science ®Google Scholar
• Sidhu BS, Sieniewicz B, Gould J, et al. Leadless left ventricular endocardial pacing for CRT upgrades in previously failed and high-risk patients in comparison with coronary sinus CRT upgrades. Europace. 2021; Oct 923(10):1577–1585. doi:10.1093/europace/euab156.
   PubMed Web of Science ®Google Scholar
• Bardy GH, Smith WM, Hood MA, et al. An entirely subcutaneous implantable cardioverter–defibrillator. N Engl J Med. 2010;363(1):36–44. doi:10.1056/NEJMoa0909545.
   PubMed Web of Science ®Google Scholar
• Ferna ́ Ndez-Palacios G, Garc ́ıa-Mora ́ N E, Sand ́ın- Fuentes M, et al. The utility of a combined synchronous atrioventricular leadless pacemaker and subcutaneous implantable cardiac defibrillator system in bilateral upper limb venous occlusion. Europace. 2020;23:814.
   Web of Science ®Google Scholar
• Tjong FVY, Brouwer TF, Koop B, et al. Acute and 3-month performance of a communicating leadless antitachycardia pacemaker and subcutaneous implantable defibrillator. JACC Clin Electrophysiol. 2017;3(13):1487–1498. doi:10.1016/j.jacep.2017.04.002.
   PubMedGoogle Scholar
• Breeman KTN, Swackhamer B, Brisben AJ, et al. Long-term performance of a novel communicating antitachycardia pacing-enabled leadless pacemaker and subcutaneous implantable cardioverter-defibrillator system: a comprehensive preclinical study. Heart Rhythm. 2022;19(5):837–846. doi:10.1016/j.hrthm.2022.01.024.
   PubMed Web of Science ®Google Scholar
• Crozier I, O'Donnell D, Boersma L, et al. The extravascular implantable cardioverter-defibrillator: the pivotal study plan. J Cardiovasc Electrophysiol. 2021;32(9):2371–2378. doi:10.1111/jce.15190.
   PubMed Web of Science ®Google Scholar
• Piemontese GP, Toniolo S, Biffi M, et al. Bridging the future of cardiac stimulation: physiologic or leadless pacing? Rev Cardiovasc Med. 2022; Mar 1723(3):107. doi:10.31083/j.rcm2303107.
   PubMed Web of Science ®Google Scholar
• Boersma LV, El-Chami M, Steinwender C, et al. Practical considerations, indications, and future perspectives for leadless and extravascular cardiac implantable electronic devices: a position paper by EHRA/HRS/LAHRS/APHRS. Europace. 2022; Oct 1324(10):1691–1708. doi:10.1093/europace/euac066.
   PubMed Web of Science ®Google Scholar