Impact of centrifugal-flow left ventricular assist device implantation on the disease course, functional class, and quality of life in patients with end-stage heart failure with reduced ejection fraction. A 6-month follow-up experience

Aim. To study mortality, postoperative complications, clinical course, and quality of life of patients with heart failure (HF) within 6 months after left ventricular assist device (LVAD) implantation.

Material and methods. The study included 53 patients who met the criteria for LVAD implantation. Twenty three patients underwent surgery (group 1), while 30 patients refused implantation (group 2). The follow-up period was 6 months. The death number and causes, hospitalization and HF decompensation rates, the changes of N-terminal pro-brain natriuretic peptide levels, the functional class of HF, the incidence of postoperative complications were assessed. Exercise tolerance (ET) was determined using a 6-minute walk test, while quality of life — using the EQ-5D questionnaire.

Results. Patient mortality in the LVAD group was 26%, while in group 2 — 23,3%. In the main group, 1 patient died due to cardiovascular cause; 2 — gastrointestinal bleeding; 1 — infectious complications (sepsis); 1 — cerebrovascular accident; 1 — acute non-occlusive mesenteric ischemia. In the control group, all death cases were due to cardiovascular pathology. Among the complications after implantation, the most common were pleurisy, delirium, ventricular tachycardia, right ventricular failure, gastrointestinal bleeding, LVAD-associated infection. In group 1, there was a significantly lower number of rehospitalizations compared to group 2, including those due to HF decompensation (p=0,034, p<0,001, respectively). In the main group, there was an improvement in the quality of life (p<0,001), HF class (p<0,001), and ET (p=0,006), which led to a reliable difference between the groups after 6 months.

Conclusion. LVAD implantation is accompanied by a decrease in the number of rehospitalizations and HF decompensation, as well as improvement of ET, HF class and quality of life of patients, but not a decrease in mortality. To reduce the incidence of postoperative complications and improve the prognosis, a more careful selection of patients for intervention, assessment of their cognitive status and compliance is necessary.

1. Polyakov DS, Fomin IV, Belenkov YuN, et al. Chronic heart failure in the Russian Federation: what has changed over 20 years of follow-up? Results of the EPOCH-CHF study. Kardiologiia. 2021;61(4):4-14. (In Russ.)

2. McDonagh TA, Metra M, Adamo M. ESC Scientific Document Group. 2021 ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure. Eur Heart J. 2021;42(36):3599-726. doi:10.1093/eurheartj/ehab368.

3. Gustafsson F, Rogers JG. Left ventricular assist device therapy in advanced heart failure: patient selection and outcomes. Eur J Heart Fail. 2017;19(5):595-602. doi:10.1002/ejhf.779.

4. Mehra MR, Goldstein DJ, Cleveland JC. Five-Year Outcomes in Patients With Fully Magnetically Levitated vs Axial-Flow Left Ventricular Assist Devices in the MOMENTUM 3 Randomized Trial. JAMA. 2022;328(12):1233-42. doi:10.1001/jama.2022.16197.

5. Jorde UP, Saeed O, Koehl D. The Society of Thoracic Surgeons Intermacs 2023 Annual Report: Focus on Magnetically Levitated Devices. Ann Thorac Surg. 2024;117(1):33-44. doi:10.1016/j.athoracsur.2023.11.004.

6. Chatterjee A, Feldmann C, Hanke JS. The momentum of HeartMate 3: a novel active magnetically levitated centrifugal left ventricular assist device (LVAD). J Thorac Dis. 2018;10(Suppl 15):S1790-S1793. doi:10.21037/jtd.2017.10.124.

7. Yuzefpolskaya M, Schroeder SE, Houston BA. The Society of Thoracic Surgeons Intermacs 2022 Annual Report: Focus on the 2018 Heart Transplant Allocation System. Ann Thorac Surg. 2023;115(2):311-27. doi:10.1016/j.athoracsur.2022.11.023.

8. Mehra MR, Cleveland JC Jr, Uriel N. MOMENTUM 3 Investigators. Primary results of long-term outcomes in the MOMENTUM 3 pivotal trial and continued access protocol study phase: a study of 2200 HeartMate 3 left ventricular assist device implants. Eur J Heart Fail. 2021;23(8):1392-400. doi:10.1002/ejhf.2211.

9. Potapov EV, Antonides C, Crespo-L eiro MG. 2019 EACTS Expert Consensus on longterm mechanical circulatory support. Eur J Cardiothorac Surg. 2019;56(2):230-70. doi:10.1093/ejcts/ezz098.

10. Ganaev KG, Dzybinskaya EV, Narusov OYu. Inhospital outcomes of implantation of a centrifugal left ventricular assist device in patients with endstage heart failure: experience of the Chazov National Medical Research Center of Cardiology. Russian Journal of Cardiology. 2024;29(6):5846. (In Russ.)

11. Kormos RL, Antonides CFJ, Goldstein DJ. Updated definitions of adverse events for trials and registries of mechanical circulatory support: A consensus statement of the mechanical circulatory support academic research consortium. J Heart Lung Transplant. 2020;39(8):735-50. doi:10.1016/j.healun.2020.03.010.

12. Frigerio M. Left Ventricular Assist Device: Indication, Timing, and Management. Heart Fail Clin. 2021;17(4):619-34. doi:10.1016/j.hfc.2021.05.007.

13. Demirozu ZT, Radovancevic R, Hochman LF. Arteriovenous malformation and gastrointestinal bleeding in patients with the HeartMate II left ventricular assist device. J Heart Lung Transplant. 2011;30(8):849-53. doi:10.1016/j.healun.2011.03.008.

14. Abdin A, Anker SD, Butler J. 'Time is prognosis' in heart failure: time-to-treatment initiation as a modifiable risk factor. ESC Heart Fail. 2021;8(6):4444-53. doi:10.1002/ehf2.13646.

15. Mangini S, Pires PV, Braga FG. Decompensated heart failure. Einstein (Sao Paulo). 2013;11(3):383-91. doi:10.1590/s1679-45082013000300022.

16. Johansson I, Joseph P, Balasubramanian K. G-CHF Investigators. Health-Related Quality of Life and Mortality in Heart Failure: The Global Congestive Heart Failure Study of 23 000 Patients From 40 Countries. Circulation. 2021;143(22):2129-42. doi:10.1161/CIRCULATIONAHA.120.050850.