Parents Guide to Pediatric Congenital Heart Defects. Cardiac Surgical Solutions. PERFORMANCE through experience

Transcription

1 Parents Guide to Pediatric Congenital Heart Defects Cardiac Surgical Solutions PERFORMANCE through experience

2 Patient Information: My child s first name: My doctors names:

3 Table of Contents The Heart 1 3 Congential Heart Defects 4 5 Products 6 13 Resources Glossary History of W. L. Gore & Associates Notes and Heart Diagram 22 24

4 The Heart

5 Vena Cava Aorta Pulmonary Artery Left Atrium Pulmonary Vein Right Atrium Right Ventricle Left Ventricle The right side of the heart (blue) receives deoxygenated blood from the body and pumps it to the lungs, where it becomes rich in oxygen. The oxygenated blood then returns to the left side of the heart (pink), which pumps it to the rest of the body. 1

6 The heart: Is an organ Made of muscle Approximately the size of your fist Located within the chest Pumps blood Needed to deliver oxygen and nutrients to the body Contains two pumps one on right side, one on left side Right side pumps blood to the lungs, where it becomes enriched with oxygen (A) Left side pumps oxygen-rich blood to the rest of the body (B) Blood flow through the heart Veins are blood vessels that return blood to the heart Veins empty blood into atria (plural of atrium), the upper chambers of heart Atriums; right atrium (C) and left atrium (D) Blood pumped through one-way valve from atrium to ventricle Tricuspid (right / E) and mitral valve (left / F) Ventricles pump blood out of the heart through one-way valve Pulmonary (right / G) and aortic valve (left / H) Blood transported to lungs and throughout the body via arteries 2

7 Vena Cava Aorta Pulmonary Artery Left Atrium B D Pulmonary Vein C G H F E Right Atrium A Right Ventricle Left Ventricle 3

8 Congenital Heart Defects Heart defects are the most common type of birth defect. Nearly 1 out of 125 are born with a heart defect in the US 1, 2 Congenital Heart Defects are structural abnormalities of the heart that are present at birth. Can involve the heart s walls, valves, and /or great vessels Parts may be incomplete / missing / put together wrong; may include holes between heart chambers; valves can be leaky or narrow; vessels may be narrow Most common types of Congenital Heart Defects are 3 : Ventricular Septal Defect (20%) Atrial Septal Defect (10%) Patent Ductus Arteriosus (10%) Aortic Coarctation (10%) Congenital Aortic Stenosis (10%) Tetralogy of Fallot (10%) Pulmonary Stenosis (10%) Heart defects may range from mild to serious and may resolve themselves as your baby grows or might need to be fixed with medications or surgery. Advances in diagnosis and surgical treatment have led to dramatic increases in survival for children with serious heart defects 1 Each patient is unique and your physician will determine the best course of treatment for your baby 4

9 1. Birth defects. Congenital heart defects. March of Dimes. Published May Accessed December 21, Congenital heart defects. What are congenital heart defects? U.S. Department of Health and Human Services. National Heart Lung and Blood Institute. Published July 01, Accessed December 21, Jacobs JP. Nomenclature and classification for congenital cardiac surgery. In: Mavroudis C, Backer CL, eds. Pediatric Cardiac Surgery. 3rd ed. Philadelphia, PA: Mosby; 2003;2:

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11 Gore has been making high-quality, reliable medical products for the surgical treatment and correction of congenital heart defects for more than 30 years. Our cardiac surgical products include: Pediatric shunts Cardiovascular patches Pericardial membranes Vascular Grafts PRODUCTS

12 GORE PROPATEN Vascular Graft Configured for Pediatric Shunt Depiction of a Blalock-Taussig shunt, a procedure that is commonly used to treat blue babies by increasing blood flow to the lungs. Consult with your physician for complete information. 6

13 GORE-TEX Vascular Graft Configured for Pediatric Shunt Some Congenital Heart Defects result in blue babies. Infants are cyanotic because of low blood oxygen levels I n cyanotic conditions, doctors try to increase blood oxygen levels by increasing blood flow to the lungs A shunt, or small diameter synthetic tube, is typically used to re-route blood flow Blalock-Taussig shunt: tube used to connect a branch of the aorta to the pulmonary artery RV-PA shunt (Sano): tube used to connect the right ventricle to the pulmonary artery Gore has been making grafts since Available in GORE PROPATEN Vascular Graft Configured for Pediatric Shunt and GORE-TEX Vascular Graft Configured for Pediatric Shunt. The GORE PROPATEN Vascular Graft Configured for Pediatric Shunt features heparin, an anticoagulant used to reduce the formation of clots in the blood stream GORE PROPATEN Vascular Graft brings an additional advantage of having an immobilized heparin surface Stretch technology makes the graft flexible and easy to handle Can be easily adapted to a wide range of anatomical configurations Available in a wide range of sizes (lengths, diameters) to pick one that is the best suited for your infant 7

14 GORE ACUSEAL Cardiovascular Patch Pulmonary artery widened with an eptfe patch Ventricular Septal Defect repaired with an eptfe patch Cardiovascular patches are used to widen the pulmonary artery and to repair a hole in the wall between the left and right ventricle, known as a Ventricular Septal Defect (VSD). They are also used to repair or reconstruct cardiac and vascular structures. Repairing holes in the walls of the heart (Atrial Septal Defect, Ventricular Septal Defect) Reconstructing a malformed vessel (Aortic Coarctation) Consult with your physician for complete information. 8

15 GORE-TEX Cardiovascular Patch Gore has been making cardiovascular patches since Available in GORE-TEX Cardiovascular Patch and GORE ACUSEAL Cardiovascular Patch. GORE ACUSEAL Cardiovascular Patch contains inner fluoroelastomeric layer Improves patch s ability to seal around sutures, offering an advantage for vascular procedures Made from eptfe material / non-biological Inert-the body doesn t react to it, strict quality control, reliable performance Patches are conformable Easy to handle, flexible, can be cut-to-size for specific application Available in a variety of thicknesses and sizes Most suitable configuration can be selected based on patient s anatomy and surgeon preference Has open microstructure Pores are large enough to accommodate cell growth on patch surface Enables patch to become integrated with native tissue 1000x Magnification 10 microns Magnified view of GORE ACUSEAL Cardiovascular Patch 9

16 GORE PRECLUDE Pericardial Membrane Pericardial Fluid Pericardium GORE PRECLUDE Pericardial Membrane is used to repair or reconstruct the pericardium. Pericardium is a fluid-filled sac surrounding the heart which helps contain it During open heart surgery, the surgeon must cut into the pericardium to access the heart Without an intact pericardium, there is an increased risk of adhesions forming between the heart and chest wall after surgery Makes re-operation difficult Obscures cardiac structures GORE PRECLUDE Pericardial Membrane covers the heart and makes re-operation easier if necessary Consult with your physician for complete information. 10

17 1000x Magnification 10 microns Magnified view of GORE PRECLUDE Pericardial Membrane Gore has been making membranes since Made from eptfe material / non-biological Inert-the body doesn t react to it, strict quality control, reliable performance Membrane is thin and conformable Easy to handle, flexible, can be tailored and draped over heart Has tight pore microstructure Designed with small pores to inhibit cell growth on membrane surface Enables membrane to maintain a plane of dissection 11

18 GORE-TEX Vascular Graft Pulmonary Artery GORE-TEX Vascular Graft Inferior Vena Cava Depiction of an Extracardiac Fontan procedure. A GORE-TEX Vascular Graft connects the inferior vena cava to the pulmonary artery. Consult with your physician for complete information. 12

19 GORE-TEX Vascular Graft can be used in a Fontan Procedure, a procedure for single ventricle heart repair. Connects inferior vena cava to the pulmonary artery Helps return oxygen saturation levels to normal An opening or fenestration may be made between the GORE-TEX Vascular Graft and the right atrium Helps relieve high blood pressure in veins Can be closed when no longer required GORE-TEX Vascular Graft can also be used to widen the pulmonary artery (sometimes called the pulmonary outflow tract). For Pulmonary Stenosis (narrowing) or Pulmonary Atresia (closed or absent) Helps increase blood flow to lungs Gore has been making grafts since Made from eptfe material / non-biological Inert-the body doesn t react to it, strict quality control, reliable performance Stretch technology makes the graft flexible and easy to handle Can be easily adapted to a wide range of anatomical configurations Available in a wide range of sizes (lengths, diameters) to pick one that is the best suited for your infant 13

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21 RESOURCES

22 Resources American College of Cardiology CardioSource American Heart Association Center of Disease Control and Prevention The Children s Heart Foundation Children s Health Information Network CongenitalHeartDefects.com Congenital Heart Surgeons Society Data Center Cove Point Foundation It s My Heart Kids With Heart Little Hearts March of Dimes US Department of Health and Human Services Food and Drug Administration US National Library of Medicine Medline Plus W. L. Gore & Associates 14

23 Resources From My Doctor 15

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25 GLOSSARY

26 Glossary Anastamosis: A surgical connection, such as the junction between a shunt and blood vessel. Anticoagulant: A drug that delays clotting (coagulation) of the blood. When administered in cases where a clot already exists, an anticoagulant tends to prevent new clots from forming or existing clots form enlarging but does not dissolve an existing clot. Anticoagulants are also used to prevent clots from forming on an artificial material. Aorta: The largest blood vessel in the body. The aorta is connected to the heart s left ventricle. The aorta carries oxygen-enriched blood to the body. Aortic Coarctation: A congenital narrowing of the aorta, the main artery that conducts blood from the heart to the body. Aortic Valve: The heart valve between the left ventricle and the aorta. It has three flaps, or cusps. Artery / Arteries: Blood vessels that carry blood away from the heart and to other tissues throughout the body. Atrium (right and left): One of the upper two chambers of the heart. The right atrium receives unoxygenated blood from the body. The left atrium receives oxygenated blood from the lungs. Blalock-Tausig Shunt (BT shunt): Tube used to connect a branch of the aorta to the pulmonary artery. Blood vessel: The pathways through which blood travels in the body. 16

27 Blue babies: Babies having a blue color of skin, called cyanosis, caused by insufficient oxygen in the arterial blood. Cardiac: Pertaining to the heart and blood vessels. Congenital Heart Defect: Malformation of the heart or of its major blood vessels, existing at birth. Cyanosis: Blueness of skin caused by insufficient oxygen in the blood. Deoxygenated Blood: Blood that contains low levels of oxygen. Blood vessels carrying deoxygenated blood typically appear blue under the skin. See blue babies. eptfe: Expanded polytetrafluoroethylene, an inert and biocompatible polymer which can be used for medical devices. Great Vessels: The four major blood vessels associated with the heart: aorta, pulmonary artery, pulmonary vein, and vena cava. Heparin: A type of anticoagulant. Hypertension: Commonly called high blood pressure. It is blood pressure above the normal range. Hypertrophy: Enlargement of a tissue or organ due to increase in the size of its cells. This may result from a demand for increased work. Lung / Lungs: Pair of breathing organs located within the chest, which remove carbon dioxide and bring oxygen to the blood. There is a right and left lung. Median Sternotomy: Incision through the midline of the chest to gain access to the heart. 17

28 Glossary Mitral Valve: The valve between the left atrium and left ventricle. It has two flaps, or cusps. Open Heart Surgery: An operation where an incision is made into the chest to get access to the heart. Oxygenated Blood: Blood that is rich in oxygen. Palliative Procedures: Operations that improve, but do not correct, an abnormal heart function. They are performed to improve heart function, usually in children too young for corrective surgery. The aim is to lessen cyanosis, to control heart failure, or to prepare the circulation for later repair. Pericardium: A thin double-layered sac which encloses the heart. Pericardial fluid is contained within the layers and lubricates the constantly rubbing surfaces. Pulmonary: Pertaining to the lungs. Pulmonary Artery: The artery connected to the heart s right ventricle that carries oxygen-depleted blood to the lungs. Pulmonary Valve: The heart valve between the right ventricle and the pulmonary artery. It has three flaps, or cusps. Pulmonary Vein: The vein that receives oxygen-rich blood from the lungs and delivers it to the heart s left atrium. Sano Shunt (RV-PA): Tube used to connect the right ventricle to the pulmonary artery. Septum: The muscular wall dividing the two chambers on the left side of the heart from the two chambers on the right. The atrial septum separates the top chambers and the ventricular septum separates the bottom chambers. 18

29 Shunt: A passage created between two natural channels, especially between blood vessels. In surgery, a shunt is the operation of forming a passage between blood vessels to divert blood from one part of the body to another. Tetralogy of Fallot: A complex congenital heart malformation consisting of: 1) an opening in the wall between the lower heart chambers (ventricular septal defect), 2) a narrowing (stenosis) of the pulmonary valve and the muscular area just beneath it, 3) thickening (hypertrophy) of the right ventricle and 4) abnormal position of the great artery (aorta). These children are cyanotic. Tricuspid Valve: The heart valve between the right atrium and right ventricle, comprised of three flaps, or cusps. Valve: An opening covered by membranous flaps between two chambers of the heart or between a chamber of the heart and a blood vessel. When it is closed, blood normally does not pass through. Vascular: Pertaining to blood vessels. Vein / Veins: Blood vessels that carry blood towards the heart from tissues throughout the body. Vena Cava: A large vein that returns unoxygenated blood from the body to the right atrium. Ventricle (right and left): One of the two lower chambers of the heart. The right ventricle pumps unoxygenated blood to the lungs. The left ventricle pumps oxygenated blood to the body. 19

30 History of W. L. Gore & Associates 1975 GORE-TEX Vascular Graft 1997 GORE EXCLUDER AAA Endoprosthesis 1993 GORE MYCROMESH Biomaterial GORE-TEX Cardiovascular Patch 1987 GORE RESOLUT Regenerative Membrane W. L. Gore & Associates was founded in 1958 when Bill and Vieve Gore set out to explore opportunities for fluorocarbon polymers, especially polytetrafluoroethylene (PTFE). Within the first twelve years, Gore had wire and cables on the moon and research, manufacturing and sales operations worldwide. Gore fluoropolymer products provide solutions for innovative medical products, next generation electronics and high-performance fabrics. 20

31 Gore Medical Products Division 2007 GORE HELEX Septal Occluder 2001 GORE VIABAHN Endoprosthesis 2011 GORE Hybrid Vascular Graft GORE TAG Thoracic Endoprosthesis 2009 GORE Flow Reversal System 2011 GORE Embolic Filter For more than 30 years, W. L. Gore & Associates, Medical Products Division, has provided surgeons and patients with a wide range of healing solutions, including synthetic blood vessels and patches for soft tissue regeneration, and surgical sutures for use in vascular, cardiac, general surgery and orthopedic procedures. Our medical products work in harmony with the body s own tissues to restore normal functions. This capability facilitates less invasive procedures and offers new solutions to medical challenges. Gore also has developed a host of support services which, by improving the diagnosis and treatment of patients conditions, meet our customers highest expectations. 21

32 Notes 22

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34 Heart Diagram Vena Cava Aorta Pulmonary Artery Left Atrium Pulmonary Vein Right Atrium Right Ventricle Left Ventricle 24

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36 W. L. Gore & Associates, Inc. Flagstaff, AZ (Asia Pacific) (Europe) (United States) (United States) goremedical.com INDICATIONS FOR USE: GORE PRECLUDE Pericardial Membrane is intended for use for reconstruction or repair of the pericardium. CONTRAINDICATIONS: Not for reconstruction of CARDIOVASCULAR DEFECTS such as cardiac, great vessel, and peripheral vascular, DURA MATER, HERNIAS. Use of this product in applications other than those indicated has the potential for serious complications, such as suture pullout or failure of the repair (aneurysm formation). Refer to Instructions for Use at goremedical.com for a complete description of all warnings, precautions and adverse events. INDICATIONS FOR USE: GORE PROPATEN Vascular Grafts are intended for use as vascular prostheses for replacement or bypass of diseased vessels in patients suffering occlusive or aneurysmal diseases, in trauma patients requiring vascular replacement, for dialysis access, or for other vascular procedures. CONTRAINDICATIONS: DO NOT use the GORE PROPATEN Vascular Graft in patients with known hypersensitivity to heparin, including those patients who have had a previous incidence of HIT type II. DO NOT use GORE PROPATEN Vascular Grafts as a patch. If cut and used as a patch, GORE PROPATEN Vascular Grafts may lack adequate transverse strength. Refer to Instructions for Use at goremedical.com for a complete description of all warnings, precautions and adverse events. INDICATIONS FOR USE: GORE-TEX Cardiovascular Patch and GORE ACUSEAL Cardiovascular Patch is intended for use in cardiovascular patching. CONTRAINDICATIONS: There are no known contraindications. Refer to Instructions for Use at goremedical.com for a complete description of all warnings, precautions and adverse events. INDICATIONS FOR USE: GORE-TEX Vascular Grafts are intended for use as vascular prostheses for replacement or bypass of diseased vessels in patients suffering occlusive or aneurysmal diseases, in trauma patients requiring vascular replacement, for dialysis access, or for other vascular procedures. CONTRAINDICATIONS: DO NOT use GORE-TEX Vascular Grafts as a patch. If cut and used as a patch, GORE-TEX Vascular Grafts may lack adequate transverse strength. For cardiovascular procedures requiring patch materials, use the appropriate GORE-TEX Cardiovascular Patch. Refer to Instructions for Use at goremedical. com for a complete description of all warnings, precautions and adverse events. Products listed may not be available in all markets. GORE, ACUSEAL, GORE-TEX, EXCLUDER, HELEX, MYCROMESH, PERFORMANCE THROUGH EXPERIENCE, PROPATEN, PROPATEN, RESOLUT, TAG, VIABAHN, and designs are trademarks of W. L. Gore & Associates W. L. Gore & Associates, Inc. AP4587-EN1 JANUARY 2012