Two-year follow-up of patients with heart failure with reduced ejection fraction receiving cardiac contractility modulation

Aim. To assess the 2-year prognosis of patients with heart failure with reduced ejection fraction (HFrEF) receiving cardiac contractility modulation (CCM).

Material and methods. This single-center observational study included 55 patients (46 men, mean age 53±11 years) with NYHA class II-III HFrEF receiving optimal medical therapy, with sinus rhythm, QRS <130 ms or QRS<150 ms with nonspecific intraventricular conduction delay. NYHA class II and III were established in 76% and 24% of patients, respectively. All patients were implanted with CCM devices between October 2016 and September 2017. Follow-up visits were carried out every 3 months during the 1^st year and every 6 months during the 2^nd year of observation. The primary composite endpoint was mortality and heart transplantation. Secondary composite endpoints included death, heart transplantation, paroxysmal ventricular tachycardia/ ventricular fibrillation, hospitalizations due decompensated HF

Results. The one-year and two-year survival rate was 95% and 80%, respectively. Primary endpoint was observed in 20% of patients. NYHA class III and higher levels of N-terminal pro-brain natriuretic peptide (NTproBNP) were associated with unfavorable prognosis (p=0,014 and p=0,026, respectively). NTproBNP was an independent predictor of survival (p=0,018). CCM contributed to a significant decrease in hospitalizations due to decompensated HF (p<0,0001). The secondary endpoint was observed in 18 (33%) of patients during the 1^st year. The predictor for the secondary composite endpoint was NTproBNP (p=0,047).

Conclusion. CCM is associated with a significant decrease in hospitalization rate due to decompensated HF. The 2-year survival rate of patients with NYHA class II-III HF receiving CCM was 80%. The NTproBNP level was an independent predictor of survival in patients receiving CMM for 2 years. Further longer-term studies of the CCM efficacy are required.

1. Ponikowski P, Voors AA, 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:101093/eurheartj/ehw128.

2. Borggrefe M, Mann DL. Cardiac Contractility Modulation in 2018. Circulation. 2018;138 (24):2738-40. doi:10.1161/CIRCULATIONAHA.118.036460.

3. Yu CM, Chan JY, Zhang Q, et al. Impact of cardiac contractility modulation on left ventricular global and regional function and remodeling. JACC Cardiovasc Imaging. 2009;2 (12):1341-9. doi:10.1016/j.jcmg.2009.07.011.

4. Vander MA, Lyasnikova EA, Kim IM, et al. Significant improvement of clinical course and reverse myocardial remodeling in young patients with chronic heart failure using cardiac contractility modulation. Russian Journal of Cardiology. 2019; (7):99-102. (In Russ.) doi:10.15829/1560-4071-2019-7-99-102.

5. Kadish A, Nademanee K, Volosin K, et al. A randomized controlled trial evaluating the safety and efficacy of cardiac contractility modulation in advanced heart failure. Am Heart J. 2011;161:329-37. doi:10.1016/j.ahj.2010.10.025.

6. Abraham WT, Kuck KH, Goldsmith RL. A randomized controlled trial to evaluate the safety and efficacy of cardiac contractility modulation. JACC Heart Fail. 2018;6:874-83. doi:10.1016/j.jchf.2018.04.010.

7. Schau T, Seifert M, Meyhofer J, et al. Long-term outcome of cardiac contractility modulation in patients with severe congestive heart failure. EP Europace. 2011 (13):1436-44. doi:10.1093/europace/eur153.

8. Kuschyk J, Roeger S, Schneider R, et al. Efficacy and survival in patients with cardiac contractility modulation: long-term single center experience in 81 patients. Int J Cardiol. 2015;183:76-81. doi:10.1016/j.ijcard.2014.12.178.

9. Kloppe A, Lawo T, Mijic D, et al. Long-term survival with cardiac contractility modulation in patients with NYHA II or III symptoms and normal QRS duration. Int J Cardiol. 2016;15;209:291-5. doi:10.1016/j.ijcard.2016.02.001.

10. Trukhacheva NV. Mathematical statistics in biomedical research using the Statistica package. Moscow: GEOTAR-Media. 2013. (In Russ.) Трухачева Н.В. Математическая статистика в медико-биологических исследованиях с применением пакета Statistica. М.: ГЭОТАР-Медиа. 2013. ISBN: 978-5-9704-2567-1.

11. Anker SD, Borggrefe M, Neuser H, et al. Cardiac contractility modulation improves longterm survival and hospitalizations in heart failure with reduced ejection fraction. Eur J Heart Fail. 2019;21 (9):1103-13. doi:10.1002/ejhf.1374.

12. Sitnikova MYu, Lyasnikova EA, Yurchenko AV, et al. Results of 3 years of operation of the Russian hospital heart Failure registry (RUS-HFR): the relationship between management and outcomes in patients with chronic heart failure. Kardiologija. 2018;58 (10):9-19. doi:10.18087/cardio.2483.

13. Mando R, Goel A, Habash F, et al. Outcomes of Cardiac Contractility Modulation: A Systematic Review and Meta-Analysis of Randomized Clinical Trials. Cardiovascular Therapeutics. 2019: ID 9769724. doi:10.1155/2019/9769724.

14. Roger S, Said S, Kloppe A, et al. Cardiac contractility modulation in heart failure patients: Randomized comparison of signal delivery through one vs. two ventricular leads. J Cardiol. 2017;69 (1):326-32. doi:10.1016/j.jjcc.2016.06.015.