CorInnova Device PDF

Word count excluding reference list and figures and figure legends: 1345 words The CorInnova Device Introduction The CorInnova device is an implantable cardiac device features a dual-chamber design using a collapsible nitinol frame and a thin film of polyurethane. The device assists with cardiac com...

Word count excluding reference list and figures and figure legends: 1345 words The CorInnova Device Introduction The CorInnova device is an implantable cardiac device features a dual-chamber design using a collapsible nitinol frame and a thin film of polyurethane. The device assists with cardiac compression by alternating between saline and air-filled compartments. The device regulates ventricular pressure, to maintain adequate arterial pressure during systole. This directly addresses the complexities of heart failure(1). Heart failure (HF) is a common condition, affecting 1-2% of the population(2). HF is a clinical syndrome in which the heart is unable to maintain sufficient cardiac output to meet the body's metabolic requirements and venous return(3). HF occurs when functional myocardial cells are depleted as a result of heart injury cause by various factors(4). Some of the main risk factors of developing HF are hypertension, diabetes mellitus, obesity and chronic infection(2). Existing medical devices for heart failure treatment come into direct contact with blood, which poses numerous potential complications(1). CorInnova's technology aims to provide a safer, more efficient and targeted device for heart failure(1). The CorInnova Device Anatomy of the heart 3D model of the heart: cardiac structure Chambers of the Heart Left ventricle Right ventricle Left atrium Right atrium The ventricles have thicker walled chambers than the atria, to pump blood out of the heart. The thickness of the wall is due to different amounts of myocardium present in the wall. The thicker the wall, the greater the force the chamber is able to generate(5). Septum Divides the heart into left and right sides. Consists of both ventricular and atrial components. Main function is to ensure efficient blood circulation. By preventing any backward flow into the heart chambers(6). Layers of the Heart 3D Model of the the heart: Venous Structure Coronary Veins Transport deoxygenated blood from the myocardium to the heart chambers. 3D Model of the Heart: Arterial Structure Valves of the Heart The heart requires valves to maintain one way flow, and the heart possess two types of valves. Atrioventricular Valves The valves between the atria and the ventricles. The right valve is tricuspid. The left valve is bicuspid(9). Semi-lunar Valve Pulmonary semi-lunar valve is between the right ventricle and pulmonary trunk. Aortic semi-lunar valve is between left ventricle and aorta(9). Left Coronary Artery Supplies the left side of the heart with oxygen and nutrients throughout its branches(9). Right Coronary Artery Supplies blood flow to the anterior and diaphragmatic surfaces. Of the right atrium, right ventricle and posterior two thirds of the inter ventricular The CorInnova Device The various stages of heart failure Heart failure results from the heart's inability to meet the body's metabolic demands, leading to elevated venous pressures and organ congestion. It stems from systolic or diastolic dysfunction, or both, alongside alterations in cardiomyocyte function and collagen turnover. Various triggers can precipitate heart failure. Systolic Heart Failure A syndrome which results from reduced left ventricular ejection fraction. Systolic heart failure involves left ventricular dilation, increasing enddiastolic and end-systolic volumes(11). The disproportionate increase in end-systolic volume reduces the left ventricular ejection fraction(11). Ejection fraction is determined by the ratio of total stroke volume to end-diastolic volume(11). Significant end-diastolic volume increase can lower ejection fraction while maintaining normal stroke volume(11). Changes in left ventricle shape cause misalignment of papillary muscles, chordae, and mitral valve leaflets, leading to mitral valve regurgitation(11). Mitral valve regurgitation further increases left ventricular volumes and promotes remodelling(11). Increased wall stress and potentially decreased wall thickness correlate with decreased ejection fraction in systolic heart failure patients(11). Diastolic heart failure The stiffening of the heart resulting in less blood being able to fill the left ventricle. Diastolic heart failure is characterised by low cardiac output due to thick walled ventricles and reduced cavity size, which increases the mass to volume ratio(12). The stiffness of the left ventricle leads to slow relaxation in early diastole and resistance to filling in late diastole, resulting in elevated diastolic pressures(12). Symptoms of diastolic heart failure include fatigue from low cardiac output, and dyspnea during exertion due to elevated end-diastolic pressures transmitted backward through the pulmonary circulation(12). Exercise tolerance may reveal the inability to increase left ventricular end-diastolic volume in order to augment stroke volume(12). Contributing mechanisms of diastolic heart failure include stiff arteries, hypertension, myocardial ischemia, diabetes and intrinsic myocardial changes, with or without associated hypertrophy(12). The CorInnova Device Diagnostics Clinical Evaluation Demonstrating an underlying dysfunction is essential for diagnosing heart failure(2). Dysfunction can stem from various cardiac abnormalities, such as myocardial infarction, valve disorders, pericardial or endocardial abnormalities, or disturbances in heart rhythm/conduction(2). Symptoms and Severity Assessment The severity of heart failure is graded according to the New York Heart Association (NYHA) classification(2). This classification system assesses symptoms at different levels of physical activity, ranging from class I (least severe) to class IV (most severe)(2). Compensatory Mechanisms and Progression Following an initial cardiac event, compensatory mechanisms are activated to maintain heart function(2). However, is these mechanisms fail to restore adequate heart function and peripheral organ perfusion, heart failure progresses(2). Diagnostic Tests Non-Invasive Tests: Echocardiography: uses sound waves to assess heart structure and function(14). MRI (magnetic Resonance Imaging): provides detailed images of the heart’s anatomy and function(17). NT-proBNP (N-Terminal pro B-type natriuretic peptide): blood tests to assess levels of a hormone associated with heart failure(20). Invasive Tests Heart Catheterisation: threading a catheter into the heart to measure pressures and obtain tissue samples if needed(22). Biopsy: tissue sample analysis to evaluate for specific heart abnormalities(24). Additional tests Blood tests: assess for biomarker indicating heart failure(25). Electrocardiogram: records the heart’s electrical activity to detect abnormalities(25). Breathing tests: evaluate lung function to identify potential contributors to breathlessness(25). X-rays: examines heart size and detects signs of fluid in the lungs or underlying lung conditions(25). Accurate heart failure diagnosis requires a thorough evaluation of symptoms, test and staging criteria. This approach allows for customised treatment, improving patient outcomes and quality of life(23). The CorInnova Device The Device The device features a collapsible nitinol frame with a dual-chamber design, utilising thin-film polyurethane chambers(1). The saline filled internal chambers allow for close conformity to the heart's epicardial surface(1). The outer polyurethane chambers cyclically fill with air, providing support during systole and diastole(1). Diastolic assistance is facilitated by nitinol's outward force on the ventricles, enhancing cardiac filling(1). A subcutaneously tunnelled driveline transmits air for chamber expansion/deflation and electrocardiogram monitoring(1). The device offers several advantages: no need for anti-coagulation, suitable for peripheral arterial disease patients, and provides biventricular assistance(1). A proof of concept study documents reproducible cardiac assistance in an ovine model of chronic heart failure(1). Operation of device CorInnova assist device inserted through small subxiphoid incision (~2 inches)(1). Pericardial apex opened (2cm diameter) for device insertion, remainder left intact(1). Device loaded into introducer tube (~2cm diameter) and placed through apical pericardiotomy(1). Nitinol frame self-expands around both ventricles, secured by intact pericardium(1). Inner chambers filled with saline for conformity to epicardial surface Device activation synchronized with ECG QRS for timed inflation (systole) and deflation (diastole)(1). Adjustable inflation and deflation for optimisation(1). Activated for 1 hour to elevate effectiveness, measurements taken before and after(1). Pressures and flow tracings recorded with device on and off, deactivated for 5 minutes after measurements(1). Critical evaluation of device The device does not directly contact blood, reducing the risk of thrombosis and vascular injury(1). No need for continuous anticoagulation medication, making device management easier and reducing he medication burden on other organs. Compared to similar devices, there is potential for a reduction in longterm complications such as bleeding and thrombosis. Leading to potentially better patient outcomes and less utilisation of healthcare resources. The devices management of complications such as pericardial adhesion or unpredictable arrhythmias. Further research is required after animal testing(29). Initial tests involved short-term studies on 7 sheep, inducing heart failure by microsphere insertion in the left circumflex coronary artery(1). Only 2 sheep were studied with this symmetrical device(1). Further large-scale research is needed to assess its functional impact on both ventricular function and resulting cardiac output(1,29). Longer-term studies are needed to assess the device's efficacy in providing adequate perfusion. Human clinical trials are necessary to evaluate its impact on heart failure and potential improvements in humans.(1) The CorInnova Device References 1. Hord EC, Bolch CM, Tuzun E, Cohn WE, Leschinsky B, Criscione JC. Evaluation of the CorInnova Heart Assist Device in an Acute Heart Failure Model. Journal of Cardiovascular Translational Research. 2019 Jan 2;12(2):155–63. 2. Schwinger RHG. Pathophysiology of heart failure. Cardiovascular Diagnosis and Therapy [Internet]. 2021 Feb;11(1):263–76. Available from: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7944197/ 3. Kemp CD, Conte JV. The Pathophysiology of Heart Failure. Cardiovascular Pathology [Internet]. 2012 Sep;21(5):365–71. Available from: https://www.sciencedirect.com/science/article/pii/S1054880711001529 4. Katz AM. The myocardium in congestive heart failure. The American Journal of Cardiology. 1989 Jan;63(2):A12–6. 5. National Cancer Institute. Structure of the Heart [Internet]. National Cancer Institute. 2019. Available from: https://training.seer.cancer.gov/anatomy/cardiovascular/heart/structure.html 6. Miranda GM. Structure and Function of the Heart [Internet]. News-Medical.net. 2022. Available from: https://www.news-medical.net/health/Structure-and-Function-of-theHeart.aspx 7. Septum of the heart: Function, defects, and more [Internet]. www.medicalnewstoday.com. 2022. Available from: https://www.medicalnewstoday.com/articles/septum-heart#summary 8. Dahal P. Layers of the Heart: Epicardium, Myocardium, Endocardium [Internet]. microbenotes.com. 2023. Available from: https://microbenotes.com/layers-of-the-heart 9. Miao JH, Makaryus AN. Anatomy, Thorax, Heart Veins [Internet]. Nih.gov. StatPearls Publishing; 2019. Available from: https://www.ncbi.nlm.nih.gov/books/NBK549786/ 10. American Heart Association. Classes of Heart Failure [Internet]. Heart.org. American Heart Association; 2017. Available from: https://www.heart.org/en/health-topics/heart-failure/whatis-heart-failure/classes-of-heart-failure 11. Federmann M, Hess OM. Differentiation between systolic and diastolic dysfunction. European heart journal [Internet]. 1994;15 Suppl D:2–6. Available from: https://www.ncbi.nlm.nih.gov/pubmed/7713107 12. The Symptoms of Diastolic Dysfunction, Causes and Treatment | Dr. Raghu [Internet]. 2022. Available from: https://drraghu.com/resources/heart-failure/what-are-the-symptoms-ofdiastolic-dysfunction/ 13. Houston BA, Brittain EL, Tedford RJ. Right Ventricular Failure. The New England Journal of Medicine. 2023 Mar 23;388(12):1111–25. 14. NHS. Echocardiogram [Internet]. NHS. 2020. Available from: https://www.nhs.uk/conditions/echocardiogram/ 15. Fogoros R. Echocardiogram: Uses, Side Effects, Procedure, Results [Internet]. Verywell Health. 2023 [cited 2024 Mar 15]. Available from: https://www.verywellhealth.com/theechocardiogram-1745246 16. Moore P. Echocardiogram (echo) [Internet]. Dysautonomia-MVP Center - Paula Moore M.D. 2022. Available from: https://www.mvpctr.com/echocardiogram/ 17. NHS. Overview - MRI Scan [Internet]. NHS. 2022. Available from: https://www.nhs.uk/conditions/mri-scan/ 18. Magnetic Resonance Imaging (MRI) [Internet]. Touchstone Medical Imaging. Available from: https://www.touchstoneimaging.com/services/mri/ 19. MRI Heart | Test Price in Delhi | Ganesh Diagnostic [Internet]. www.ganeshdiagnostic.com. [cited 2024 Mar 15]. Available from: https://www.ganeshdiagnostic.com/mri-heart 20. B-type natriuretic peptide (NT-pro BNP) [Internet]. Gloucestershire Hospitals NHS Foundation Trust. Available from: https://www.gloshospitals.nhs.uk/our-services/serviceswe-offer/pathology/tests-and-investigations/b-type-natriuretic-peptide-nt-probnp/ 21. New blood test tweak could better detect heart failure [Internet]. www.bhf.org.uk. [cited 2024 Mar 15]. Available from: https://www.bhf.org.uk/what-we-do/news-from-the-bhf/newsarchive/2019/november/new-blood-test-tweak-could-better-detect-heart-failure 22. NHS Choices. Overview - Cardiac Catheterisation and Coronary Angiography [Internet]. NHS. 2019. Available from: https://www.nhs.uk/conditions/coronary-angiography/ 23. What Is Cardiac Catheterization? [Internet]. Verywell Health. Available from: https://www.verywellhealth.com/cardiac-catheterization-and-angiography-1745251 24. NHS. Overview - Biopsy [Internet]. NHS. 2019. Available from: https://www.nhs.uk/conditions/biopsy/ 25. American Heart Association. Common Tests for Heart Failure [Internet]. www.heart.org. 2017. Available from: https://www.heart.org/en/health-topics/heart-failure/diagnosing-heartfailure/common-tests-for-heart-failure 26. Letsou GV, Bolch CM, Hord EC, Altman WC, Leschinsky B, Criscione JC. The CorInnova Implantable Cardiac Assist System for Direct Cardiac Compression. Reviews in Cardiovascular Medicine. 2022 Jun 9;23(6):211–1.