Модуляция сердечной сократимости как возможность терапии хронической сердечной недостаточности у пациентов с синусовым ритмом и фибрилляцией предсердий

Сердечная недостаточность (СН) остается одной из главных проблем здравоохранения в мире. Несмотря на большое количество уже существующих медикаментозных препаратов с доказанной эффективностью и различных высокотехнологичных устройств, из-за большой экономической нагрузки на здравоохранение и негативного влияния на качество жизни непрерывно ведутся поиски новых возможностей лечения и профилактики СН. Развитие фибрилляции предсердий (ФП) у пациентов с ХСН значительно ухудшает прогноз течения заболевания и увеличивает смертность от всех причин. Внедрение в клиническую практику нового поколения устройств модуляции сердечной сократимости Optimizer Smart® является перспективным направлением в терапии пациентов с ХСН и ФП, не имеющих показаний или не получивших достаточного клинического эффекта от ресинхронизирующей терапии (СРТ).

�ивших достаточного клинического эффекта от ресинхронизирующей терапии (СРТ).

1. Ponikowski P, Anker SD, AlHabib KF, Cowie MR, Force TL, Hu S et al. Heart failure: preventing disease and death worldwide: Addressing heart failure. ESC Heart Failure. 2014;1(1):4–25. DOI: 10.1002/ehf2.12005

2. Mozaffarian D, Benjamin EJ, Go AS, Arnett DK, Blaha MJ, Cushman M et al. Heart Disease and Stroke Statistics—2016 Update: A Report from the American Heart Association. Circulation. 2016;133(4):e38–360. DOI: 10.1161/CIR.0000000000000350

3. Rasoul D, Ziaei F, Shan S, Khan J, Bhayani R, Shakir S et al. 11 The Decennial Relationship between Heart Failure and Atrial Fibrillation – A Large Population Study. Heart. 2016;102(Suppl 6):A7.2-A8. DOI: 10.1136/heartjnl-2016-309890.11

4. Benjamin EJ, Levy D, Vaziri SM, D’Agostino RB, Belanger AJ, Wolf PA. Independent risk factors for atrial fibrillation in a population-based cohort. The Framingham Heart Study. JAMA. 1994;271(11):840–4. PMID: 8114238

5. De Ferrari GM, Klersy C, Ferrero P, Fantoni C, Salerno-Uriarte D, Manca L et al. Atrial fibrillation in heart failure patients: Prevalence in daily practice and effect on the severity of symptoms. Data from the ALPHA study registry. European Journal of Heart Failure. 2007;9(5):502–9. DOI: 10.1016/j.ejheart.2006.10.021

6. Pozzoli M, Cioffi G, Traversi E, Pinna GD, Cobelli F, Tavazzi L. Predictors of primary atrial fibrillation and concomitant clinical and hemodynamic changes in patients with chronic heart failure: a prospective study in 344 patients with baseline sinus rhythm. Journal of the American College of Cardiology. 1998;32(1):197–204. DOI: 10.1016/S0735-1097(98)00221-6

7. Swedberg K, Olsson LG, Charlesworth A, Cleland J, Hanrath P, Komajda M et al. Prognostic relevance of atrial fibrillation in patients with chronic heart failure on long-term treatment with beta-blockers: results from COMET. European Heart Journal. 2005;26(13):1303–8. DOI: 10.1093/eurheartj/ehi166

8. Hoppe UC, Casares JM, Eiskjær H, Hagemann A, Cleland JGF, Freemantle N et al. Effect of Cardiac Resynchronization on the Incidence of Atrial Fibrillation in Patients with Severe Heart Failure. Circulation. 2006;114(1):18–25. DOI: 10.1161/CIRCULATIONAHA.106.614560

9. Calvo N, Bisbal F, Guiu E, Ramos P, Nadal M, Tolosana JM et al. Impact of atrial fibrillation-induced tachycardiomyopathy in patients undergoing pulmonary vein isolation. International Journal of Cardiology. 2013;168(4):4093–7. DOI: 10.1016/j.ijcard.2013.07.017

10. Morris PD, Robinson T, Channer KS. Reversible heart failure: toxins, tachycardiomyopathy and mitochondrial abnormalities. Postgraduate Medical Journal. 2012;88(1046):706–12. DOI: 10.1136/postgrad-medj-2011-130698

11. Daoud EG, Weiss R, Bahu M, Knight BP, Bogun F, Goyal R et al. Effect of an irregular ventricular rhythm on cardiac output. The American Journal of Cardiology. 1996;78(12):1433–6. PMID: 8970422

12. Olsson LG, Swedberg K, Ducharme A, Granger CB, Michelson EL, McMurray JJV et al. Atrial fibrillation and risk of clinical events in chronic heart failure with and without left ventricular systolic dysfunction: results from the Candesartan in Heart failure-Assessment of Reduction in Mortality and morbidity (CHARM) program. Journal of the American College of Cardiology. 2006;47(10):1997–2004. DOI: 10.1016/j.jacc.2006.01.060

13. Zareba W, Piotrowicz K, McNitt S, Moss AJ. Implantable Cardioverter-Defibrillator Efficacy in Patients with Heart Failure and Left Ventricular Dysfunction (from the MADIT II Population). The American Journal of Cardiology. 2005;95(12):1487–91. DOI: 10.1016/j.amjcard.2005.02.021

14. Liang JJ, Callans DJ. Ablation for Atrial Fibrillation in Heart Failure with Reduced Ejection Fraction. Cardiac Failure Review. 2018;4(1):1. DOI: 10.15420/cfr.2018:3:1

15. Braunwald E. Heart failure. JACC. Heart failure. 2013;1(1):1–20. DOI: 10.1016/j.jchf.2012.10.002

16. Ringer S. A further Contribution regarding the influence of the different Constituents of the Blood on the Contraction of the Heart. The Journal of Physiology. 1883;4(1):29-42.3. PMID: 16991336

17. Mayourian J, Ceholski DK, Gonzalez DM, Cashman TJ, Sahoo S, Hajjar RJ et al. Physiologic, Pathologic, and Therapeutic Paracrine Modulation of Cardiac Excitation-Contraction Coupling. Circulation Research. 2018;122(1):167–83. DOI: 10.1161/CIRCRESAHA.117.311589

18. Braunwald’s heart disease: a textbook of cardiovascular medicine. 9thed. -Philadelphia: Saunders; Editors: Braunwald, E, Bonow, RO 2012.-1961p. ISBN 978-1-4377-0398-6

19. Wanwarang W, Shin-Ann Chen. Atrial Fibrillation Pathophysiology Heart Failure. The Journal of innovations in cardiac rhythm management. [Internet] 2012. Available at: http://www.innovationsincrm.com/cardiac-rhythm-management/2012/july/300-atrial-fibrillation-pathophysiology-heart-failure

20. Chang S-L, Chen Y-C, Yeh Y-H, Lin Y-K, Wu T-J, Lin C-I et al. Heart Failure Enhanced Pulmonary Vein Arrhythmogenesis and Dysregulated Sodium and Calcium Homeostasis with Increased Calcium Sparks. Journal of Cardiovascular Electrophysiology. 2011;22(12):1378–86. DOI: 10.1111/j.1540-8167.2011.02126.x

21. Nattel S. Ionic determinants of atrial fibrillation and Ca2+ channel abnormalities : cause, consequence, or innocent bystander? Circulation Research. 1999;85(5):473–6. PMID: 10473677

22. Heijman J, Voigt N, Nattel S, Dobrev D. Cellular and Molecular Electrophysiology of Atrial Fibrillation Initiation, Maintenance, and Progression. Circulation Research. 2014;114(9):1483–99. DOI: 10.1161/CIRCRESAHA.114.302226

23. Ponikowski P, Voors AA, Anker SD, Bueno H, Cleland JGF, Coats AJS et al. 2016 ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure: The Task Force for the diagnosis and treatment of acute and chronic heart failure of the European Society of Cardiology (ESC) Developed with the special contribution of the Heart Failure Association (HFA) of the ESC. European Heart Journal. 2016;37(27):2129–200. DOI: 10.1093/eurheartj/ehw128

24. Packer M, Kowey PR. Building Castles in the Sky: Catheter Ablation in Patients with Atrial Fibrillation and Chronic Heart Failure. Circulation. 2018;138(8):751–3. DOI: 10.1161/CIRCULATIONAHA.118.034583

25. Duncker D, Veltmann C. Device therapy in heart failure with reducedejection fraction—cardiac resynchronization therapy and more. Herz. 2018;43(5):415–22. DOI: 10.1007/s00059-018-4710-6

26. Schwartz PJ, De Ferrari GM, Sanzo A, Landolina M, Rordorf R, Raineri C et al. Long term vagal stimulation in patients with advanced heart failure First experience in man. European Journal of Heart Failure. 2008;10(9):884–91. DOI: 10.1016/j.ejheart.2008.07.016

27. Mareev V. Yu., Fomin I. V., Ageev F. T., Begrambekova Yu. L., Vasyuk Yu. A., Garganeeva A. A. et al. Russian Heart Failure Society, Russian Society of Cardiology. Russian Scientific Medical Society of Internal Medicine Guidelines for Heart failure: chronic (CHF) and acute decompensated (ADHF). Diagnosis, prevention and treatment. Kardiologiia. 2018;58(S6):8–164. [Russian: Мареев В. Ю., Фомин И. В., Агеев Ф. Т., Беграмбекова Ю. Л., Васюк Ю. А., Гарганеева А. А. и др. Клинические рекомендации ОССН – РКО – РНМОТ. Сердечная недостаточность: хроническая (ХСН) и острая декомпенсированная (ОДСН). Диагностика, профилактика и лечение. Кардиология. 2018;58(S6):8-164]. DOI: 10.18087/cardio.2475

28. Bryant AR, Wilton SB, Lai MP, Exner DV. Association between QRS duration and outcome with cardiac resynchronization therapy: A systematic review and meta-analysis. Journal of Electrocardiology. 2013;46(2):147–55. DOI: 10.1016/j.jelectrocard.2012.12.003

29. Stavrakis S, Garabelli P, Reynolds DW. Cardiac resynchronization therapy after atrioventricular junction ablation for symptomatic atrial fibrillation: a meta-analysis. Europace. 2012;14(10):1490–7. DOI: 10.1093/europace/eus193

30. Koplan BA, Kaplan AJ, Weiner S, Jones PW, Seth M, Christman SA. Heart failure decompensation and all-cause mortality in relationto percent biventricular pacing in patients with heart failure. Journal of the American College of Cardiology. 2009;53(4):355–60. DOI: 10.1016/j.jacc.2008.09.043

31. Hayes DL, Boehmer JP, Day JD, Gilliam FR, Heidenreich PA, Seth M et al. Cardiac resynchronization therapy and the relationship of percent biventricular pacing to symptoms and survival. Heart Rhythm. 2011;8(9):1469–75. DOI: 10.1016/j.hrthm.2011.04.015

32. Cheng A, Landman SR, Stadler RW. Reasons for loss of cardiac resynchronization therapy pacing: insights from 32 844 patients. Circulation: Arrhythmia and Electrophysiology. 2012;5(5):884–8. DOI: 10.1161/CIRCEP.112.973776

33. Abraham WT, Zile MR, Weaver FA, Butter C, Ducharme A, Halbach M et al. Baroreflex Activation Therapy for the Treatment of Heart Failure with a Reduced Ejection Fraction. JACC: Heart Failure. 2015;3(6):487–96. DOI: 10.1016/j.jchf.2015.02.006

34. Barostim Neo® -Baroreflex Activation Therapy® for Heart Failure -Full Text View -ClinicalTrials.gov. [Internet] Available at: https://clinicaltrials.gov/ct2/show/NCT02627196

35. Borggrefe M, Burkhoff D. Clinical effects of cardiac contractility modulation (CCM) as a treatment for chronic heart failure. EuropeanJournal of Heart Failure. 2012;14(7):703–12. DOI: 10.1093/eurjhf/hfs078

36. Impulse Dynamics – Innovative HF Therapy Solution. Av. at: https://www.impulse-dynamics.com/int/.

37. Wood EH, Heppner RL, Weidmann S. Inotropic Effects of Electric Currents. Circulation Research. 1969;24(3):409–45. DOI: 10.1161/01.RES.24.3.409

38. Antoni H, Jacob R, Kaufmann R. Mechanical response of the frog and mammalian myocardium to changes in the action potential duration by constant current pulses. Pflugers Archiv European Journal of Physlology. 1969;306(1):33–57. DOI: 10.1007/BF00586610

39. Sabbah HN, Haddad W, Mika Y, Nass O, Aviv R, Sharov VG et al. Cardiac contractility modulation with the impulse dynamics signal: studies in dogs with chronic heart failure. Heart Failure Reviews. 2001;6(1):45–53. PMID: 11248767

40. Pappone C, Vicedomini G, Salvati A, Meloni C, Haddad W, Aviv R et al. Electrical modulation of cardiac contractility: clinical aspects in congestive heart failure. Heart Failure Reviews. 2001;6(1):55–60. PMID: 11248768

41. Pappone C, Rosanio S, Burkhoff D, Mika Y, Vicedomini G, Augello G et al. Cardiac contractility modulation by electric currents applied during the refractory period in patients with heart failure secondary to ischemic or idiopathic dilated cardiomyopathy. The American Journal of Cardiology. 2002;90(12):1307–13. DOI: 10.1016/S0002-9149(02)02868-0

42. Stix G. Chronic electrical stimulation during the absolute refractory period of the myocardium improves severe heart failure. European Heart Journal. 2004;25(8):650–5. DOI: 10.1016/j.ehj.2004.02.027

43. Giallauria F, Vigorito C, Piepoli MF, Stewart Coats AJ. Effects of cardiac contractility modulation by non-excitatory electrical stimulation on exercise capacity and quality of life: An individual patient’s data meta-analysis of randomized controlled trials. International Journal of Cardiology. 2014;175(2):352–7. DOI: 10.1016/j.ijcard.2014.06.005

44. Bellmann B, Roser M, Muntean BG. A defective implanted defibrillator or not -that is the question! Kerala Heart Journal. 2016;5(2):http://keralaheartjournal.in/ojs/index.php/KHJ/article/view/61

45. Röger S, Said S, Kloppe A, Lawo T, Emig U, Rousso B et al. Cardiac contractility modulation in heart failure patients: Randomized comparison of signal delivery through one vs. two ventricular leads. Journal of Cardiology. 2017;69(1):326–32. DOI: 10.1016/j.jjcc.2016.06.015

46. Kuschyk J, Stach K, Tülümen E, Rudic B, Liebe V, Schimpf R et al. Subcutaneous implantable cardioverter-defibrillator: First single-center experience with other cardiac implantable electronic devices. Heart Rhythm. 2015;12(11):2230–8. DOI: 10.1016/j.hrthm.2015.06.022

47. Kloppe A, Mijic D, Schiedat F, Bogossian H, Mügge A, Rousso B et al. A randomized comparison of 5 versus 12 hours per day of cardiac contractility modulation treatment for heart failure patients: A preliminary report. Cardiology Journal. 2016;23(1):114–9. DOI: 10.5603/CJ.a2015.0073

48. Burkhoff D, Shemer I, Felzen B, Shimizu J, Mika Y, Dickstein M et al. Electric currents applied during the refractory period can modulate cardiac contractility in vitro and in vivo. Heart Failure Reviews. 2001;6(1):27–34. PMID: 11248765

49. Morita H, Suzuki G, Haddad W, Mika Y, Tanhehco EJ, Sharov VG et al. Cardiac contractility modulation with nonexcitatory electric signals improves left ventricular function in dogs with chronic heart failure. Journal of Cardiac Failure. 2003;9(1):69–75. DOI: 10.1054/jcaf.2003.8

50. Imai M, Rastogi S, Gupta RC, Mishra S, Sharov VG, Stanley WC et al. Therapy with Cardiac Contractility Modulation Electrical Signals Improves Left Ventricular Function and Remodeling in Dogs with Chronic Heart Failure. Journal of the American College of Cardiology. 2007;49(21):2120–8. DOI: 10.1016/j.jacc.2006.10.082

51. Blank M, Goodman R. Initial interactions in electromagnetic field-induced biosynthesis. Journal of Cellular Physiology. 2004;199(3):359–63. DOI: 10.1002/jcp.20004

52. Zhang F-F, Qi X-Y, Li Y-X, Dang Y, Liu H-L, Yuan H-B et al. Cardiac contractility modulation improves cardiac function in a rabbit model of chronic heart failure. 2017;28(4):1894–9

53. Blank M. Protein and DNA Reactions Stimulated by Electromagnetic Fields. Electromagnetic Biology and Medicine. 2008;27(1):3–23. DOI: 10.1080/15368370701878820

54. Marban E, Koretsune Y. Cell calcium, oncogenes, and hypertrophy. Hypertension. 1990;15(6_pt_1):652–8. DOI: 10.1161/01.HYP.15.6.652

55. Zhang F, Dang Y, Li Y, Hao Q, Li R, Qi X. Cardiac Contractility Modulation Attenuate Myocardial Fibrosis by Inhibiting TGF-β1/Smad3 Signaling Pathway in a Rabbit Model of Chronic Heart Failure. Cellular Physiology and Biochemistry. 2016;39(1):294–302. DOI: 10.1159/000445624

56. Butter C, Rastogi S, Minden H-H, Meyhöfer J, Burkhoff D, Sabbah HN. Cardiac Contractility Modulation Electrical Signals Improve Myocardial Gene Expression in Patients with Heart Failure. Journal of the American College of Cardiology. 2008;51(18):1784–9. DOI: 10.1016/j.jacc.2008.01.036

57. Borggrefe MM, Lawo T, Butter C, Schmidinger H, Lunati M, Pieske B et al. Randomized, double blind study of non-excitatory, cardiac contractility modulation electrical impulses for symptomatic heart failure. European Heart Journal. 2008;29(8):1019–28. DOI: 10.1093/eurheartj/ehn020

58. Kadish A, Nademanee K, Volosin K, Krueger S, Neelagaru S, Raval N et al. A randomized controlled trial evaluating the safety and efficacy of cardiac contractility modulation in advanced heart failure. American Heart Journal. 2011;161(2):329-337.e2. DOI: 10.1016/j.ahj.2010.10.025

59. Abraham WT, Nademanee K, Volosin K, Krueger S, Neelagaru S, Raval N et al. Subgroup Analysis of a Randomized Controlled Trial Evaluating the Safety and Efficacy of Cardiac Contractility Modulation in Advanced Heart Failure. Journal of Cardiac Failure. 2011;17(9):710–7. DOI: 10.1016/j.cardfail.2011.05.006

60. Schau T, Seifert M, Meyhofer J, Neuss M, Butter C. Long-term outcome of cardiac contractility modulation in patients with severe congestive heart failure. Europace. 2011;13(10):1436–44. DOI: 10.1093/europace/eur153

61. Kuschyk J, Roeger S, Schneider R, Streitner F, Stach K, Rudic B et al. Efficacy and survival in patients with cardiac contractility modulation: Long-term single center experience in 81 patients. International Journal of Cardiology. 2015;183:76–81. DOI: 10.1016/j.ijcard.2014.12.178

62. Kloppe A, Lawo T, Mijic D, Schiedat F, Muegge A, Lemke B. Long term survival with Cardiac Contractility Modulation in patients

63. with NYHA II or III symptoms and normal QRS duration. International Journal of Cardiology. 2016;209:291–5. DOI: 10.1016/j.ij-card.2016.02.001

64. Liu M, Fang F, Luo XX, Shlomo B-H, Burkhoff D, Chan JYS et al. Improvement of long-term survival by cardiac contractility modulation in heart failure patients: A case–control study. International Journal of Cardiology. 2016;206:122–6. DOI: 10.1016/j.ijcard.2016.01.071

65. Grigioni F, Carinci V, Boriani G, Bracchetti G, Potena L, Magnani G et al. Accelerated QRS widening as an independent predictor of cardiac death or of the need for heart transplantation in patients with congestive heart failure. The Journal of Heart and Lung Transplantation: The Official Publication of the International Society for Heart Trans-plantation. 2002;21(8):899–902. PMID: 12163090

66. Röger S, Michels J, Heggemann F, Stach K, Rousso B, Borggrefe M et al. Long term impact of cardiac contractility modulation on QRS duration. Journal of Electrocardiology. 2014;47(6):936–40. DOI: 10.1016/j.jelectrocard.2014.08.011

67. Nagele H, Behrens S, Eisermann C. Cardiac contractility modulation in non-responders to cardiac resynchronization therapy. Europace. 2008;10(12):1375–80. DOI: 10.1093/europace/eun257

68. Abi-Samra F, Gutterman D. Cardiac contractility modulation: a novel approach for the treatment of heart failure. Heart Failure Reviews. 2016;21(6):645–60. DOI: 10.1007/s10741-016-9571-6

69. Kloppe A, Boesche L, Aweimer A, Ewers A, Schoene D, Patsalis P et al. Acute and short term safety and feasibility of the new OPTIMIZER SMART-system: Is it reasonable to avoid an atrial lead? EP Europace. 2018;20(suppl_1):i48–i48. DOI: 10.1093/europace/euy015.128

70. Revishvili A. Sh., Artyukhina E. A., Amiraslanov A. Yu., Vaskovsky V. A., Yashkov M. V., Kuptsov V. V. et al. The first experience of treatment of patients with chronic heart failure using cardiac contractility modulation device. Journal of arrhythmology. 2017;(90):12–8. [Russian: Ревишвили А. Ш., Артюхина Е. А, Амирасланов А. Ю., Васковский В. А., Яшков М. В., Купцов В. В., Ожерельева М. В. Первый опыт лечения пациентов с хронической сердечной недостаточностью методом имплантации устройств, модулирующих сокращения сердца. Вестник аритмологии. 2017;(90):12-8]