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Published Online:https://doi.org/10.2217/fca-2021-0117

Implantable cardiac defibrillators have revolutionized the way we prevent sudden cardiac death via arrhythmias. The addition of cardiac resynchronization pacing to defibrillators has broadened that treatment to include patients with heart failure and reduced ejection fraction. As with all technology, new devices and platforms expand the capabilities and interface with patients across the world. This review discusses the evolution from the initial modalities and methods of communication of implantable devices up to the most recent advances in implantable defibrillators and their integration into patient lives and clinical practice. This review is focused on the integration of Bluetooth communication into modern healthcare with the Gallant™ family of devices, the first branded launch by Abbott Laboratories.

Plain language summary

The evolution in the ability of implantable cardioverter defibrillators to communicate has evolved quickly since their inception. In parallel, the volume of data and clinical utilities have also adapted how we manage our patients. Fast and reliable access to accurate clinical data allows for more deliberate and timely management of arrhythmia patients. The advent of Bluetooth technology and its recent integration into implantable medical devices may not only satisfy the clinicians needs, but also fill in some longstanding gaps for patients to participate in their own care. We discuss the Gallant™ ICD family of Implantable defibrillators and their advantages and design aspects of integrating Bluetooth technology.

Papers of special note have been highlighted as: • of interest; •• of considerable interest

References

  • 1. Kong MH, Fonarow GC, Peterson ED. Systematic review of the incidence of sudden cardiac death in the United States. J. Am. Coll. Cardiol. 57, 794–801 (2011).
  • 2. Moss AJ, Zareba W, Hall WJ et al. Prophylactic implantation of a defbrillator in patients with myocardial infarction and reduced ejection fraction. N. Engl. J. Med. 346(12), 877–883 (2002).
  • 3. Wang M, Peterson DR, Rosero S et al. Effectiveness of implantable cardioverter-defibrillators to reduce mortality in patients with long QT syndrome. J. Am. Coll. Cardiol. 78(21), 2076–2088 (2012).
  • 4. Mascia G, Bona RD, Ameri P, Canepa M, Porto I, Brignole M. Brugada syndrome and syncope: A systematic review. J. Cardiovas. Electrophysiol. 31(12), 3334–3338 (2020).
  • 5. Roston TM, Jones K, Hawkins NM et al. Implantable cardioverter-defibrillator use in catecholaminergic polymorphic ventricular tachycardia: a systematic review. Heart Rhythm 15(12), 1791–1799 (2018).
  • 6. Abraham WT, Fisher WG, Smith AL et al. Cardiac resynchronization in chronic heart failure. N. Engl. J. Med. 346(24), 1845–1853 (2002).
  • 7. Cleland JG, Daubert JC, Erdmann E et al. The effect of cardiac resynchronization on morbidity and mortality in heart failure. N. Engl. J. Med. 352(15), 1539–1549 (2005).
  • 8. Moss AJ, Hall WJ, Cannom DS et al. Cardiac-resynchronization therapyfor the prevention of heart-failure events. N. Engl. J. Med. 361(14), 1329–1338 (2009).
  • 9. Tang AS, Wells GA, Talajic M et al. Cardiac-resynchronization therapy for mild-to-moderate heart failure. N. Engl. J. Med. 363(25), 2385–2395 (2005).
  • 10. Sweeney MO, Wathen MS, Volosin K et al. Appropriate and inappropriate ventricular therapies, quality of life, and mortality among primary and secondary prevention implantable cardioverter defibrillator patients: results from the pacing fast VT reduces shock therapies (PainFREE Rx II) trial. Circulation 111(22), 2898–2905 (2005).
  • 11. Whang W, Albert CM, Sears SF Jr et al. Depression as a predictor for appropriate shocks among patients with implantable cardioverter-defibrillators: results from the triggers of ventricular arrhythmias (TOVA) study. J. Am. Coll. Cardiol. 45(7), 1090–1095 (2005). • This reference highlights the psychological ramifications of device implantation and coping which is an often-overlooked aspect of cardiac device patient care.
  • 12. Parsonnet V, Cuddy TE, Escher DJW et al. A permanent pacemaker capable of external non-invasive programming. Trans. Am. Soc. Artif. Intern. Org. 19, 224–228 (1973).
  • 13. Tyers FO, Brownlee RR. A multiparameter telemetry system for cardiac pacemakers. Cardiac Pacing: A Concise Guide to Clinical Practice. Lea & Febiger, PA, USA, 349–368 (1979).
  • 14. Kusumoto FMGoldschlager NF (Eds). Cardiac pacing for the clinician. Springer Science & Business Media (2007).
  • 15. Chow EY, Morris MM, Irazoqui PP. Implantable RF medical devices: The benefits of high-speed communication and much greater communication distances in biomedical applications. IEEE Microwave Magazine 14(4), 64–73 (2013).
  • 16. US Code of Federal Regulations. Title 47 Telecommunications CFR 0.1 refers to title 47, part 0, section 1 (2016). https://www.govinfo.gov/content/pkg/CFR-2016-title47-vol1/pdf/CFR-2016-title47-vol1.pdf
  • 17. Biotronik. ICD Manuals and IFU retrieved from (2021). https://manuals.biotronik.com/emanuals-professionals/?country=US&product=Icd/iShock/Acticor_US
  • 18. St Jude Medical. High voltage manuals retrieved from (2013). https://manuals.sjm.com〉product-manual-pdfs
  • 19. Medtronic. Cobalt ICD and CRTD system manual retrieved from (2021). https://www.medtronic.com/us-en/healthcare-professionals/products/cardiac-rhythm/icd-systems/cobalt.html
  • 20. Mishra S, Sigh NK, Rousseau V. System on chip interfaces for low power design 1st-Edition 29–51 (2016).
  • 21. Furman S, Parker B, Escher DJW. Transtelephone pacemaker clinic. J. Thorac. Cardiovasc Surgery 61, 827–834 (1971).
  • 22. Leahy RA, Davenport EE. Home monitoring for cardiovascular implantable electronic devices: benefits to patients and to their follow-up clinic. AACN Advanced Critical Care 26(4), 343–355 (2015).
  • 23. Burri H, Senouf D. Remote monitoring and follow-up of pacemakers and implantable cardioverter defibrillators. Europace 11(6), 701–709 (2009).
  • 24. Jung W, Rillig A, Birkemeyer R, Miljak T, Meyerfeldt U. Advances in remote monitoring of implantable pacemakers, cardioverter defibrillators and cardiac resynchronization therapy systems. J. Interv. Card. Electrophysiol. 23(1), 73–85 (2008).
  • 25. Parthiban N, Esterman A, Mahajan R et al. Remote monitoring of implantable cardioverter-defibrillators: a systematic review and meta-analysis of clinical outcomes. J. Am. Coll. Cardiol. 65(24), 2591–2600 (2015). • This study shows the stark contrast in levels of acceptance with early stages of remote monitoring based on its publication date in early 2015 compared to its issuance as standard of care in today's recommendations.
  • 26. Varma N, Piccini JP, Snell J, Fischer A, Dalal N, Mittal S. The relationship between level of adherence to automatic wireless remote monitoring and survival in pacemaker and defibrillator patients. J. Am. Coll. Cardiol. 65(24), 2601–2610 (2015).
  • 27. Slotwiner D, Varma N, Akar JG et al. HRS Expert Consensus Statement on remote interrogation and monitoring for cardiovascular implantable electronic devices. Heart Rhythm 12(7), e69–e100 (2015). • This consensus emphasizes that remote monitoring has become the standard of care in cardiac implantable devices.
  • 28. Rosenfeld LE, Patel AS, Ajmani VB, Holbrook RW, Brand TA. Compliance with remote monitoring of ICDS/CRTDS in a real-world population. Pacing and Clinical Electrophysiology 37(7), 820–827 (2014).
  • 29. Varma N, Piccini JP, Snell J, Fischer A, Dalal N, Mittal S. The relationship between level of adherence to automatic wireless remote monitoring and survival in pacemaker and defibrillator patients. J. Am. Coll. Cardiology 65, 2601–2610 (2015).
  • 30. Cronin EM, Ching EA, Varma N, Martin DO, Wilkoff BL, Lindsay BD. Remote monitoring of cardiovascular devices: a time and activity analysis. Heart Rhythm 9, 1947–1951 (2012).
  • 31. Akar JG, Bao H, Jones P et al. Use of remote monitoring of newly implanted cardioverter-defibrillators: insights from the patient related determinants of ICD remote monitoring (PREDICT RM) study. Circulation 128(22), 2372–2383 (2103).
  • 32. Mittal S, Ferrara M, Geordan S et al. Reliability of wireless connectivity with the REVEAL LINQ insertable cardiac monitor. Heart Rhythm 12(Suppl. 5), AB07-04 (2015).
  • 33. Mead H, Andres E, Ramos C, Siegel B, Regenstein M. Barriers to effective self-management in cardiac patients: the patient's experience. Patient Education and Counseling 79(1), 69–76 (2010).
  • 34. Reges O, Vilchinsky N, Leibowitz M, Khaskia A, Mosseri M, Kark JD. Identifying barriers to participation in cardiac prevention and rehabilitation programmes via decision tree analysis: establishing targets for remedial interventions. Open Heart 1(1), e000097 (2014).
  • 35. Riegel B, Carlson B. Facilitators and barriers to heart failure self-care. Patient Education and Counseling 46(4), 287–295 (2002).
  • 36. Mittal S, Piccini JP, Snell J, Prillinger JB, Dalal N, Varma N. Improved survival in patients enrolled promptly into remote monitoring following cardiac implantable electronic device implantation. J. Interv. Card. Electrophysiol. 46(2), 129–136 (2016).
  • 37. Hindricks G, Taborsky M, Glikson M et al. Implant-based multiparameter telemonitoring of patients with heart failure (IN-TIME): a randomised controlled trial. The Lancet 384(9943), 583–590 (2014).
  • 38. Varma N, Love CJ, Schweikert R, Moll P, Michalski J, Epstein AE, TRUST Investigators. Automatic remote monitoring utilizing daily transmissions: transmission reliability and implantable cardioverter defibrillator battery longevity in the TRUST trial. EP Europace 20(4), 622–628 (2018).
  • 39. Manyam H, Casado-Arroyo R, Lennerz C et al. Smartphone based CIED remote monitoring: improved compliance and connectivity APHRS AB; S50088 (2021). https://onlinesys02.hoohui.cn/electronPoster/#/infoList/0/a0842935-29cb-4152-9af1-bb88937750bd/2/0 • This Gallant™ specific reference demonstrates the utility of BLE connectivity and its impact on the speed of treatment with a phone based APP.
  • 40. Lampert R, Olshansky B, Heidbuchel H et al. Safety of sports for athletes with implantable cardioverter-defibrillators: results of a prospective, multinational registry. Circulation 127(20), 2021–2030 (2013). • This very interesting analysis by PEW demonstrates how well the aging population adopt to new technology.
  • 41. Haugaa KH, Potpara TS, Boveda S et al. Patients' knowledge and attitudes regarding living with implantable electronic devices: results of a multicentre, multinational patient survey conducted by the European Heart Rhythm Association. EP Europace 20(2), 386–391 (2018).
  • 42. Petersen HH, Larsen MC, Nielsen OW Kensing F, Svendsen JH. Patient satisfaction and suggestions for improvement of remote ICD monitoring. J. Interv. Card Electrophysiol. 34(3), 317–324 (2012). • This literature review is a comprehensive analysis examining the frequently unstudied psychosocial aspects of cardiac defibrillator implantation.
  • 43. US Food and Drug Administration. Postmarket management of cybersecurity in medical devices: guidance for industry and food and drug administration staff (2016). https://www.fda.gov/downloads/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm482022.pdf
  • 44. Varma N, Cygankiewicz I, Turakhia MP et al. ISHNE/HRS/EHRA/APHRS expert collaborative statement on mHealth in arrhythmia management: digital medical tools for heart rhythm professionals: from the International Society for Holter and Noninvasive Electrocardiology/Heart Rhythm Society/European Heart Rhythm Association/Asia-Pacific Heart Rhythm Society. Circulation: Arrhythmia and Electrophysiology 14(2), e009204 (2021).
  • 45. Luderitz B, Werner J, Deister A, Marneros A, Manz M. Patient acceptance of the implantable cardioverter defibrillator in ventricular tachyarrhythmias. Pacing. Clin. Electrophysiol. 16, 1815–1821 (1993).
  • 46. Burke LJ. Securing life through technology acceptance: The first six months after transvenous internal cardioverter implantation. Heart Lung 25(5), 352–366 (1996).
  • 47. Burns JL, Serber ER, Keim S, Sears SF. Measuring patient acceptance of implantable cardiac device therapy: initial psychometric investigation of the Florida Patient Acceptance Survey. J. Card. Electrophysiol 16(4), 384–390 (2005).
  • 48. Anderson M, Perrin A. Technology use among seniors. Pew Research Center for Internet & Technology, DC, USA (2017).
  • 49. Vaportzis E, Clausen MG, Gow AJ. Older adults experiences of learning to use tablet computers: a mixed methods study. Front Psychol. 9, 1631 (2018).
  • 50. Tilz RR, Shaik N, Piorkowski C et al. Real-world adoption of smartphone-based remote monitoring using the confirm Rx insertable cardiac monitor. J. Innov. Card. Rhythm Manag. 12(8), 4613 (2021).
  • 51. Sears SF Jr, Todaro JF, Lewis TS, Sotile W, Conti JB. Examining the psychosocial impact of implantable cardioverter defibrillators: a literature review. Clin. Cardiol. 22, 481–489 (1999).
  • 52. Cooper DK, Luceri RM, Thurer RJ, Myerburg RJ. The impact of the automatic implantable cardioverter defibrillator on quality of life. Clinical Progress in Electrophysiology and Pacing 4(4), 306–309 (1986).
  • 53. Heller SS, Ormont MA, Lidagoster L, Sciacca RR, Steinberg JS. Psychosocial outcome after ICD implantation: a current perspective. Pacing Clin. Electrophysiol. 21(6), 1207–1215 (1998).
  • 54. Dunbar SB, Dougherty CM, Sears SF et al. Educational and psychological interventions to improve outcomes for recipients of implantable cardioverter defibrillators and their families. Circulation 126, 2146–2172 (2012).
  • 55. Groeneveld PW, Matta MA, Suh JJ, Yang F, Shea JA. Quality of life among implantable cardioverter-defibrillator recipients in the primary prevention therapeutic era. Pacing Clin. Electrophysiol. 30, 463–471 (2007).
  • 56. Alexander B, Haseeb S, Baranchuk A. Are implanted electronic devices hackable? Trends Cardiovasc. Med. 29(8), 476–480 (2019).
  • 57. Abbott. Gallant entrant ICD manual retrieved from (2020). https://www.cardiovascular.abbott/us/en/hcp/manuals-and-technical-resources.html
  • 58. Varma N, Hu Y, Connolly AT et al. Gain in real-world cardiac resynchronization therapy efficacy with SyncAV dynamic optimization: heart failure hospitalizations and costs. Heart Rhythm 18(9), 1577–1585 (2021). •• Mortality benefit is demonstrated the Sync-AV™ feature incorporated into the Gallant family of devices.
  • 59. Wilkoff BL, Sterns LD, Katcher MS et al. Novel ventricular tachyarrhythmia detection enhancement detects undertreated life-threatening arrhythmias. Heart Rhythm O2 3(1), 70–78 (2021). •• A new algorithm incorporated into the Gallant family called TherapyAssure™ which ensures therapy is delivered in the event of under-sensed events.
  • 60. Nadeem F, Nunez Garcia A, Thach Tran C, Wu M. Magnetic interference on cardiac implantable electronic devices from Apple iPhone MagSafe technology. J. Am. Heart Assoc. 10, e020818 (2021).
  • 61. Ezzat VA, Lee V, Ahsan S et al. A systematic review of ICD complications in randomised controlled trials versus registries: is our ‘real-world’ data an underestimation? Open Heart 2(1), e000198 (2015).
  • 62. Santini L, D'Onofrio A, Dello Russo A et al. Prospective evaluation of the multisensor HeartLogic algorithm for heart failure monitoring. Clin. Cardiol. 43(7), 691–697 (2020).
  • 63. D'Onofrio A, Solimene F, Calò L et al. Combining Home Monitoring temporal trends from implanted defibrillators and baseline patient risk profile to predict heart failure hospitalizations: results from the SELENE HF study. EP Europace 24(2), 234–244 (2021).