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Global Regenerative Trade

MAGELLAN®

CARDIAC SURGERY

CONTENTS

1. WHAT IS REGENERATIVE MEDICINE

2.PATHOLOGY

    2.1 Heart Failure

   2.1.1 Ischemic Heart Disease

2.1.2 Diabetes

2.1.3 High Blood Pressure

2.1.4 Other

   2.3 Acute Coronary Syndrome

   2.4 Myocardial Infarction

3. SUPPORTING EVIDENCE

4. VIDEOS

WHAT IS REGENERATIVE MEDICINE?

Regenerative Medicine encompasses many medical fields – Orthopedics and Spine Surgery, Sports Medicine, Gynecology, Urology, Oncology, Dermatology, Plastic surgery, Vascular Surgery, Cardiac surgery, etc.

Regenerative Medicine is the branch of medicine that develops methods to regrow, repair or replace damaged or diseased cells, organs or tissues. Regenerative medicine includes the generation and use of therapeutic stem cells, tissue engineering and the production of artificial organs. It uses autologous blood, bone marrow or adipose components to stimulate the body’s own repair processes. A common source for regenerative cells and growth factors are bone marrow aspirate concentrate (BMAC), platelet rich plasma (obtained from one’s own blood) and adipose derived stem cells.

PATHOLOGY

HEART FAILURE

Heart failure is a condition in which the heart can’t pump enough blood to meet the body’s needs. In some cases, the heart can’t fill with enough blood. In other cases, the heart can’t pump blood to the rest of the body with enough force. Some people have both problems.

The term “heart failure” doesn’t mean that your heart has stopped or is about to stop working. However, heart failure is a serious condition that requires medical care.

Overview

Heart failure develops over time as the heart’s pumping action grows weaker. The condition can affect the right side of the heart only, or it can affect both sides of the heart. Most cases involve both sides of the heart.

Right-side heart failure occurs if the heart can’t pump enough blood to the lungs to pick up oxygen. Left-side heart failure occurs if the heart can’t pump enough oxygen-rich blood to the rest of the body.

Right-side heart failure may cause fluid to build up in the feet, ankles, legs, liver, abdomen, and the veins in the neck. Right-side and left-side heart failure also may cause shortness of breath and fatigue (tiredness).

The leading causes of heart failure are diseases that damage the heart. Examples include ischemic heart disease, high blood pressure, and diabetes.

Conditions that damage or overwork the heart muscle can cause heart failure. Over time, the heart weakens. It isn’t able to fill with and/or pump blood as well as it should. As the heart weakens, certain proteins and substances might be released into the blood. These substances have a toxic effect on the heart and blood flow, and they worsen heart failure.

Causes of heart failure include:

  • Ischemic heart disease
  • Diabetes
  • High blood pressure
  • Other heart conditions or diseases
  • Other factors

 

Ischemic Heart Disease

Ischemic heart disease is a condition in which a waxy substance called plaque builds up inside the coronary arteries. These arteries supply oxygen-rich blood to your heart muscle.

Plaque narrows the arteries and reduces blood flow to your heart muscle. The buildup of plaque also makes it more likely that blood clots will form in your arteries. Blood clots can partially or completely block blood flow. Ischemic heart disease can lead to chest pain or discomfort called angina, a heart attack, and heart damage.

 

Diabetes

Diabetes is a disease in which the body’s blood glucose (sugar) level is too high. The body normally breaks down food into glucose and then carries it to cells throughout the body. The cells use a hormone called insulin to turn the glucose into energy.

In diabetes, the body doesn’t make enough insulin or doesn’t use its insulin properly. Over time, high blood sugar levels can damage and weaken the heart muscle and the blood vessels around the heart, leading to heart failure.

 

High Blood Pressure

Blood pressure is the force of blood pushing against the walls of the arteries. If this pressure rises and stays high over time, it can weaken your heart and lead to plaque buildup.

Blood pressure is considered high if it stays at or above 140/90 mmHg over time. (The mmHg is millimeters of mercury—the units used to measure blood pressure.) If you have diabetes or chronic kidney disease, high blood pressure is defined as 130/80 mmHg or higher.

 

Other Heart Conditions or Diseases

Other conditions and diseases also can lead to heart failure, such as:

  • Arrhythmia. Happens when a problem occurs with the rate or rhythm of the heartbeat.
  • Cardiomyopathy. Happens when the heart muscle becomes enlarged, thick, or rigid.
  • Congenital heart defects. Problems with the heart’s structure are present at birth.
  • Heart valve disease. Occurs if one or more of your heart valves doesn’t work properly, which can be present at birth or caused by infection, other heart conditions, and age.

 

Other Factors

Other factors also can injure the heart muscle and lead to heart failure. Examples include:

  • Alcohol abuse or cocaine and other illegal drug use
  • HIV/AIDS
  • Thyroid disorders (having either too much or too little thyroid hormone in the body)
  • Too much vitamin E
  • Treatments for cancer, such as radiation and chemotherapy

About 5.7 million people in the United States have heart failure. The number of people who have this condition is growing.

Heart failure is more common in:

  • People who are age 65 or older. Aging can weaken the heart muscle. Older people also may have had diseases for many years that led to heart failure. Heart failure is a leading cause of hospital stays among people on Medicare.
  • Blacks are more likely to have heart failure than people of other races. They’re also more likely to have symptoms at a younger age, have more hospital visits due to heart failure, and die from heart failure.
  • People who are overweight. Excess weight puts strain on the heart. Being overweight also increases your risk of heart disease and type 2 diabetes. These diseases can lead to heart failure.
  • People who have had a heart attack. Damage to the heart muscle from a heart attack and can weaken the heart muscle.

Children who have congenital heart defects also can develop heart failure. These defects occur if the heart, heart valves, or blood vessels near the heart don’t form correctly while a baby is in the womb. Congenital heart defects can make the heart work harder. This weakens the heart muscle, which can lead to heart failure. Children don’t have the same symptoms of heart failure or get the same treatments as adults. This Health Topic focuses on heart failure in adults.

ACUTE CORONARY SYNDROME

Acute coronary syndrome (ACS) is a syndrome (set of signs and symptoms) due to decreased blood flow in the coronary arteries such that part of the heart muscle is unable to function properly or dies.The most common symptom is chest pain, often radiating to the left shoulder or angle of the jaw, crushing, central and associated with nausea and sweating. Many people with acute coronary syndromes present with symptoms other than chest pain, particularly, women, older patients, and patients with diabetes mellitus.

Acute coronary syndrome is commonly associated with three clinical manifestations, named according to the appearance of the electrocardiogram (ECG): ST elevation myocardial infarction (STEMI, 30%), non-ST elevation myocardial infarction (NSTEMI, 25%), or unstable angina (38%). There can be some variation as to which forms of myocardial infarction (MI) are classified under acute coronary syndrome.

ACS should be distinguished from stable angina, which develops during physical activity or stress and resolves at rest. In contrast with stable angina, unstable angina occurs suddenly, often at rest or with minimal exertion, or at lesser degrees of exertion than the individual’s previous angina (“crescendo angina”). New-onset angina is also considered unstable angina, since it suggests a new problem in a coronary artery.

Signs and symptoms

The cardinal symptom of critically decreased blood flow to the heart is chest pain, experienced as tightness around or over the chest and (often, but not always) radiating to the left arm and the left angle of the jaw. This may be associated with diaphoresis (sweating), nausea and vomiting, as well as shortness of breath. In many cases, the sensation is “atypical”, with pain experienced in different ways or even being completely absent (which is more likely in female patients and those with diabetes). Some may report palpitations, anxiety or a sense of impending doom (angor animi) and a feeling of being acutely ill. The description of the chest discomfort as a pressure has little utility in aiding a diagnosis as it is not specific for ACS.

Though ACS is usually associated with coronary thrombosis, it can also be associated with cocaine use. Chest pain with features characteristic of cardiac origin (angina) can also be precipitated by profound anemia, brady- or tachycardia (excessively slow or rapid heart rate), low or high blood pressure, severe aortic valve stenosis (narrowing of the valve at the beginning of the aorta), pulmonary artery hypertension and a number of other conditions.

Prevention

Acute coronary syndrome often reflects a degree of damage to the coronaries by atherosclerosis. Primary prevention of atherosclerosis is controlling the risk factors: healthy eating, exercise, treatment for hypertension and diabetes, avoiding smoking and controlling cholesterol levels; in patients with significant risk factors, aspirin has been shown to reduce the risk of cardiovascular events.

After a ban on smoking in all enclosed public places was introduced in Scotland in March 2006, there was a 17% reduction in hospital admissions for acute coronary syndrome. 67% of the decrease occurred in non-smokers.

MYOCARDIAL INFARCTION

Myocardial infarction (MI), also known as a heart attack, occurs when blood flow decreases or stops to a part of the heart, causing damage to the heart muscle. The most common symptom is chest pain or discomfort which may travel into the shoulder, arm, back, neck or jaw. Often it occurs in the center or left side of the chest and lasts for more than a few minutes. The discomfort may occasionally feel like heartburn. Other symptoms may include shortness of breath, nausea, feeling faint, a cold sweat or feeling tired. About 30% of people have atypical symptoms. Women more often present without chest pain and instead have neck pain, arm pain or feel tired. Among those over 75 years old, about 5% have had an MI with little or no history of symptoms. An MI may cause heart failure, an irregular heartbeat, cardiogenic shock or cardiac arrest.

Most MIs occur due to coronary artery disease. Risk factors include high blood pressure, smoking, diabetes, lack of exercise, obesity, high blood cholesterol, poor diet and excessive alcohol intake, among others. The complete blockage of a coronary artery caused by a rupture of an atherosclerotic plaque is usually the underlying mechanism of an MI. MIs are less commonly caused by coronary artery spasms, which may be due to cocaine, significant emotional stress and extreme cold, among others. A number of tests are useful to help with diagnosis, including electrocardiograms (ECGs), blood tests and coronary angiography. An ECG, which is a recording of the heart’s electrical activity, may confirm an ST elevation MI (STEMI), if ST elevation is present. Commonly used blood tests include troponin and less often creatine kinase MB.

SUPPORTING EVIDENCE

PUBLICATIONS

  1. Jeevananthan V, et al. Adult bone marrow cell therapy improves survival and induces long-term improvement in cardiac parameters: a systematic review and meta-analysisCirculation. 2012; doi: 10.1161/circulationaha.111.086074.
  2. Patel AN, et al. Evaluation of autologous platelet rich plasma for cardiac surgery: outcome analysis of 2000 patientsJ Cardiothorac Surg. 2016. 11(1):62. doi: 10.1186/s13019-016-0452-9
  3. Englert 2005 Sternal Wound Healing Enhanced with Magellan PRP vs. without PRP_Level I
  4. Giusti_2009_Identification of an optimal concentration of platelet gel for promoting angiogenesis in human endothelial cells

  5. Patel 2016 Sternotomy + PRP Decreased Cost & Complications vs. Sternotomy Alone for Cardiac Surgery

  6. Rath_2014_Platelet expression of transforming growth factor beta 1 is enhanced

  7. Patel 2015 Delivery of BMAC to Patients with Heart Failure.
  8. Dzau 2005 Therapeutic Potential of Endothelial SCs in Cardiovascular Diseases Review
  9. Goldthwaite Chapter – Mending a Broken Heart – SCs and Cardiac Repair
  10. Jeevanathan_2012_Adult Bone Marrow Cell Therapy Improves Survival and Induces longterm improvement in cardiac parameters a systemic review and meta-a
  11. Schulman 2012 Developments in SC Therapy in Cardiology Review.
  12. Turan_2012_Enhanced mobilization of the bone marrow derived circulating progenitor cells by intracoronary freshly isolated BM cell transplantation in patients with acute MI
  13. Asahara_1999_VEGF contributes to postnatal neovascularization by mobilizing bone marrow-derived endothelial progenitor cells
  14. Assmus 2014 Clinical Outcome After Application of BM MNCs for Myocardial Infarction
  15. Aziz_2008_Effect of bone marrow derived mesenchymal stem cells on cardiovascular complications in diabetic rats

VIDEOS

Vivostat Logo

THE VIVOSTAT® SYSTEM

The uniqueness of the Vivostat® system is a novel patented biotechnological process that enables reliable and reproducible preparation of autologous Fibrin Sealant or Platelet Rich Fibrin (PRF®) without using cryoprecipitation and without the need for a separate thrombin component.

THE FULLY AUTOMATED VIVOSTAT® SYSTEM CONSISTS OF THREE COMPONENTS:

  • The Processor Unit is a non-sterile, reusable, fully automated device that controls the biochemical process.
  • The Processor Unit is used to process the patient’s blood and prepare the Vivostat® Fibrin Sealant or Vivostat PRF® solution.
Vivostat Processor Product
  • The Processor Unit is operated by a single button and a display keeps the nurse informed of the remaining process time and status at all times. No specific installation is required and the large wheelbase makes moving it easy.
  • The Processor Unit can be located in any room or corridor in the operating department. It is most often placed centrally between the operating theatres. This way one Processor Unit can supply a number of operating theatres.
  • In approx.  25 min a concentrated fibrin sealant or PRF® solution is prepared from the patient’s whole blood.
  • The Applicator Unit is a non-sterile, reusable, fully automated device that controls the delivery of the Vivostat® Fibrin Sealant or Vivostat PRF®.
Vivostat Processor Product
  • The large display and integrated microprocessor automatically primes the Spraypen® and informs the surgeon of the remaining volume of fibrin sealant/PRF® throughout the entire process.
  • Different spray modes can be selected depending on the actual procedure or area to be covered. Like the Processor Unit it has a large wheelbase and can easily be moved if required.
  • The disposable set comprises of two parts: A Preparation Kit used to prepare the fibrin sealant or PRF® solution before surgery, and an Application Kit used to activate and apply the fibrin sealant/PRF® solution.

 

  • Preparation Kit
    The Preparation Kit contains the specially designed Preparation Unit – a sterile disposable device in which the patient’s blood is collected, the biochemical process carried out, and the fibrin sealant or PRF® solution harvested.

 

  • The Application Kit
    The Application Kit contains the Spraypen®1 and all other items required to prepare the system for the delivery of the fibrin sealant or PRF® solution. The Spraypen® is a sterile, disposable, hand held device which delivers the fibrin sealant or PRF® solution to the tissue. The revolutionary and patented design offers the surgeon unparalleled freedom in controlling the application unlike any other product on the market today.

 

1Besides the Spraypen®, the Vivostat® system offers different types of applicators, e.g. the Endoscopic Applicator. For a full list of application devices click here

1-2-3 Spray

Three easy steps to prepare Vivostat® Fibrin Sealant or Vivostat PRF®

1. Draw blood from the Patient

Fibrin Prep With Blood Inside

At the time of surgery or up to 24 hours before1, citrate (supplied with the kit) is added to the Preparation Unit. 120 ml of the patient’s own blood is then drawn into the same unit.

2. Process the patient’s blood

Vivostat Processor 800

The Preparation Unit is placed in the Processor Unit. At the touch of a button the process starts; after approx. 25 minutes, an autologous fibrin or PRF® solution is ready for use. No thrombin or bovine components are added to the blood at any time.

3. Load the Applicator Unit and spray

Vivostat Display Applicator

The Fibrin or PRF® solution is easily loaded into the Applicator Unit and applied to the surgical site using one of the unique application devices (e.g. the Spraypen). 1This depends on the type of kit being used. Always consult the “Instructions for Use” supplied with the kit to determine the correct preparation.

The following video illustrates how to prepare and apply autologous fibrin sealant.

Presentation DVD from Vivostat A/S on Vimeo.