Alexey Koroteev*

Professor, Moscow Sechenov Medical University, Russia

*Corresponding Author: Alexey Koroteev, Professor, Moscow Sechenov Medical University, Russia.

Received: April 03, 2023; Published: May 17, 2023

Abstract

Objective: The aim of the study was to assess the long-term effects of the AKOR® extracardiac mesh implantation alone or in combination with mitral valve replacement (MVR) on left ventricular (LV) structure and function in patients with idiopathic dilated cardiomyopathy (IDCM) and heart failure, evaluate the safety and efficacy of this procedure.

Background: Dilated cardiomyopathy progression depends on ventricular remodeling. Changes in myocardial stroma based on collagen type I/type III ratio, affect cardiac compliance and lead to further LV dilation. The originally designed “AKOR^®” extracardiac mesh was implemented in the trial. It was different from the ACORN CorCap CSD, that was used in previous trials. The trial was aimed to check, whether its implantation (alone or in combination with MVR) may compensate negative changes in myocardial stroma and prevent remodeling development.

Methods: A total of 36 patients with IDCM, severe LV dysfunction and advanced heart failure (NYHA class III-IV) were enrolled in the trial. All patients underwent extracardiac mesh of original design implantation either alone (Group I; n = 16) or in combination with MVR (Group II; n = 20). Long-term results were followed up to 4 years postop. Echocardiograms were obtained annually until the last patient was followed for 4 years. Standard measurements of LV volumes and dimensions, ejection fraction were made. The NYHA functional class, 6-min walking distance, working capacity were evaluated at annual checkups.

Results: The total LV EDD preoperatively was 7,2 ± 0,8 cm; LV EDV 258,5 ± 76,3 ml; LV ejection fraction 24,7 ± 6,7%. There were no cases of intraoperative mortality in both groups. The total 4 years’ actuarial survival in total group was 79,6 ± 7,4% (p < 0,05). The 4 years’ actuarial survival in Group I (AKOR mesh alone) was 92,7 ± 7,0% (p < 0.05). The 4 years’ actuarial survival in Group II (AKOR mesh +MVR) was 70,0 ± 2,5% (p < 0.05). The LV EDD diameter decreased in total group by 13% (from 7,2 ± 0,8 cm to 6,1 ± 0,5 cm; p < 0.05). The LV EDV decreased by 38% (from 258,5 ± 76,3 ml to 160,8 ± 19,7ml; p < 0.05). There were no cases of LV EDD or LV EDV increase after AKOR mesh implantation. LV EF increased from 24,7 ± 6,7% to 38,5 ± 5,6%. The number of annual hospitalizations decreased 3 times. NYHA mean class changed from 3,3 ± 0,7 to 2,0 ± 0,5 (p < 0,05). 19 (52,7%) patients restored working capacity. In 7 (19,4%) patients the AKOR^® mesh implantation stimulated the trend for reverse LV remodeling and NYHA class improvement.

Conclusions: The AKOR^® extracardiac mesh implantation (alone or in combination with MVR) stopped remodeling progression in IDCM patients, improved cardiac structure and functional status. When implemented in the adaptive stage of LV remodeling it may stimulate reverse heart remodeling. No signs of cardiac constriction were noted. Randomized controlled trials are needed to further evaluate the efficacy of this medical technology.

 Keywords: Dilated Cardiomyopathy; Extracardiac Mesh

References

1. Dec GW and Fuster V. “Idiopathic Dilated Cardiomyopathy”. The New England Journal of Medicine 331 (1994): 1564-1575.
2. Hanselmann A., et al. “Dilated cardiomyopathies and non-compaction cardiomyopathy”. Herz3 (2020): 212-220.
3. Seferovic PM., et al. “Heart failure in cardiomyopathies: a position paper from the Heart Failure Association of the European Society of Cardiology”. European Journal of Heart Failure5 (2020): 553-576.
4. Nicolini F and Gherli T. “Alternatives to transplantation in the surgical therapy for heart failure”. European Journal of Cardio-Thoracic Surgery2 (2009): 214-228.
5. Soliman H and Rossi F MV. “Cardiac fibroblast diversity in health and disease”. Matrix Biology 91-92 (2020): 75-91.
6. Singh D., et al. “Regulation of Collagen I and Collagen III in Tissue Injury and Regeneration”. Cardiology and Cardiovascular Medicine 1 (2023): 5-16.
7. Goldstein S., et al. “Ventricular remodeling”. Cardiology Clinics 16 (1998): 623-632.
8. Hetzer R., et al. “Organ-saving surgical alternatives to treatment of heart failure”. Cardiovascular Diagnosis and Therapy 1 (2021): 213-225.
9. Starling RC and Jessup M. “Worldwide clinical experience with the CorCap Cardiac Support Device”. Journal of Cardiac Failure 10 (2004): S225-233.
10. Oz MC., et al. “Global surgical experience with the Acorn cardiac support device”. The Journal of Thoracic and Cardiovascular Surgery 126 (2003): 983-991.
11. Konertz WF., et al. “Passive containment and reverse remodeling by a novel textile cardiac support device”. Circulation 104 (2001): I270-1275.
12. Kleber FX., et al. “Follow-up on passive cardiomyoplasty in congestive heart failure: influence of the Acorn ® Cardiac Support Device on left ventricular function”. Journal of the American College of Cardiology 37 (2001): 143A.
13. Mann DL., et al. “Beneficial effects of the CorCap cardiac support device: Five-year results from the Acorn Trial”. The Journal of Thoracic and Cardiovascular Surgery 5 (2012): 1036-1042.
14. Medical Devices Dispute Resolution Panel Meeting. Briefing Information Vol I.H: History of Events for IDE G990267 (2006).
15. Wenk JF., et al. “Biventricular finite element modeling of the Acorn CorCap Cardiac Support Device on a failing heart”. The Annals of Thoracic Surgery 6 (2013): 2022-2027.
16. Park J., et al. “Electromechanical cardioplasty using a wrapped elasto-conductive epicardial mesh”. Science Translational Medicine344 (2016): 344ra86.
17. Roche ET., et al. “Soft robotic sleeve supports heart function”. Science Translational Medicine373 (2017): eaaf3925.
18. Payne C., et al. “Soft robotic ventricular assist device with septal bracing for therapy of heart failure”. Science Robotics 2.12 (2017): eaan6736.

Citation

Citation: Alexey Koroteev. “The Akor® Extracardiac Mesh Implantation in Dilated Cardiomyopathy Management”.Acta Scientific Medical Sciences 7.6 (2023): 62-69.

Copyright

Copyright: © 2023 Alexey Koroteev. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.