Transcatheter Aortic Valve Implantation (TAVI) Department of Cardiorespiratory Medicine Information for Patients i University Hospitals of Leicester NHS Trust
Introduction Transcatheter aortic valve implantation (TAVI) is a newly developed procedure that has been trialled in Europe and in the UK at Glenfield Hospital. It is of special interest to patients with the heart condition called aortic stenosis when the risk of conventional open heart surgery is considered too high due to advanced age, other health problems or their general medical condition. This booklet will help you understand what to expect before, during and after the procedure. If you have any questions that the booklet does not answer there are helpful contact numbers listed at the end. It is important to understand that not all patients originally considered for this procedure by a cardiology consultant or surgeon will necessarily have the TAVI procedure. Reasons for this include: The base (called the annulus) of the diseased valve being too big or small for any existing replacement valve to fit. Other specific aspects or abnormalities of the diseased valve and the area around it which may make it difficult to carry out the procedure completely and/or safely. Severe narrowing, disease, crooked or distorted shape of the artery which is used to approach the heart with the replacement valve. 2
Introduction (continued) If you are being considered for TAVI please be assured that you will be kept fully informed about the issues affecting your clinical eligibility for this procedure by an appropriate healthcare professional. The heart and the circulation The heart is the pumping organ of the body which is responsible for the circulation of blood Head through the lungs and to the other organs. Blood circulating under enough pressure from the heart Lungs ensures that vital oxygen and nutrients are delivered to these organs and waste products are removed via the lungs, kidneys, liver and the bowels. Heart The heart has four valves to keep the blood moving in the right direction through its four chambers. The aortic valve lies between the main pumping chamber called the left ventricle and the main artery called the aorta. The aorta channels the blood via smaller vessels to the various organs. KEY Liver Rest of body Gut Blood carrying carbon dioxide in veins Blood carrying oxygen in arteries 3
The heart and the circulation Aorta Left Atrium Right Atrium Aortic Valve Pulmonary Valve Mitral Valve Tricuspid Valve Left Ventricle Right Ventricle What is aortic stenosis? Aortic stenosis is a disease process causing narrowing of the aortic valve. It affects the forward flow of blood through the aorta and causes the left ventricle to work harder to pump efficiently. As the disease progresses over time more blood is left in the ventricle after pumping. This leads to thickening and loosening of the ventricle s muscle, a process in the end leading to heart failure. This means that the patient can develop a lowered blood pressure causing tiredness, dizziness and fainting. Fluid can sometimes collect on the lung tissue, resulting in shortness of breath and even chest pain. Once these signs develop, aortic stenosis will also reduce life expectancy. 4
Options for treatment If you have aortic stenosis and are not experiencing any symptoms you will still need to have regular check ups from your doctor. If you are experiencing heart failure symptoms the medicines prescribed by your doctor might keep you fairly well for a period. However, they will not release the valve s mechanical obstruction to the blood flow. The only effective long term treatment is to replace the diseased valve. Heart valve replacement, until now, involved an open heart operation, which patients over 80 years of age or and with other medical conditions, were at greater risk of death. As an alternative, a keyhole method has been developed using a valve specially constructed in a laboratory. This new valve can be mounted onto a tube called a catheter and put into place over the diseased valve in the heart, via a major artery called the femoral artery (transfemoral approach). It can then immediately take over its work. Access to the femoral artery is gained through the groin. If access to the femoral artery is not possible, then the catheter can access the heart via a small incision on the left side of the chest, between the ribs (transapical approach) or beneath the collar bone (subclavian approach). The procedure as a whole is performed by a consultant cardiologist with a team consisting of a heart surgeon, anaesthetist and consultant echocardiographer (a heart imaging specialist). Trials of the procedure in the UK and Europe have so far shown that it can be safely carried out. 5
Options for treatment (continued) Diagram of the implantable valve positioned over the diseased aortic valve Site of aortic valve The aorta One type of the prosthetic valve Site of the diseased valve NHS funding The evidence to support TAVI is growing but is not yet absolutely conclusive. Surgical aortic valve replacement remains the standard first line treatment for those patients who can tolerate surgery. This means that there is no guarantee that the NHS will pay for the treatment. It will be useful to discuss this matter with your consultant so that you can consider the options available. Commissioners, the people who plan and pay for hospital services on behalf of their local populations, see TAVI as an emerging technology and are working with specialists to agree which patients would benefit most from TAVI as more evidence becomes available. East Midlands' commissioners, in agreement with the team at Glenfield Hospital, have committed to support TAVI for a limited number of patients based on the population of each county. 6
What are the possible benefits of the TAVI procedure? Although there are several stages of preparing patients for TAVI, the procedure itself takes around one hour. Successful valve implantation will hopefully quickly and significantly improve the symptoms and life expectancy related to aortic stenosis by correcting the root cause. However, health problems relating to other areas of the heart or other body organs may not necessarily improve. Therefore the benefits vary according to the individual patient. Please discuss this with your consultant. What are the possible complications of TAVI? There are a number of risks that any patient will have to consider when giving legal consent to have the procedure done. These include: Bruising Wound pain Bleeding or damage to the groin (up to 15% risk) Heart rhythm problems Requirement of a permanent pacemaker A clot forming in the circulation which may lead to a stroke or heart attack (2-5% risk) The onset of new heart failure symptoms Fluid collecting around the heart Misplacement of the valve or damage to the heart during the procedure Severe valve leakage Reduced kidney function (2-5% risk) Death from the procedure (5-10% risk) 7
What are the possible complications of TAVI? (continued) Transapical implantation patients have a slightly greater risk of bleeding complications than with the transfemoral approach but, conversely, there is a slightly lower risk of a stroke. The total risks are broadly comparable. Subclavian access patients: specific complications to this approach include possible damage to the nerve supply to the arm. Such damage could cause loss of function, which may be temporary or permanent. We cannot quantify these risks precisely, as we do not yet have figures based upon a sufficiently large group of patients that can accurately tell us how likely it is for any of these to occur. Each patient s level of risk is dependent on their health prior to the procedure. On the basis of their present understanding, experts in the field of heart medicine and surgery are confident that for older and less medically fit patients, the risk of death with the TAVI procedure should be considerably less than the average 15-20% risk currently estimated for conventional open heart surgery for these patients. The risk to any individual patient is always judged by a multi-disciplinary team including a consultant cardiologist, imaging doctor, cardiac surgeon and referring specialist. Please discuss your individual risk with your consultant prior to giving your consent. It should also be remembered that the procedure and the artificial valve itself have been developed through painstaking research and that every known precaution will be taken, including an operating theatre team being kept on standby during the procedure. 8
Before the procedure If you are referred for a TAVI procedure you will firstly need to discuss it with your consultant cardiologist who may refer you to a cardiologist who is trained to do the procedure. If this consultant decides that you may be suitable for TAVI they will organise some tests. These include blood tests, an echocardiogram (echo) and a cardiac catheter, information on which is provided separately. Please ask your nurse for more information. Pre-admission and screening for MRSA If you live within Leicestershire or one of the surrounding counties you will be asked to attend a pre-admission appointment at Glenfield Hospital prior to both the cardiac catheter and the TAVI procedure. A nurse will assess your present condition and medical history. Further information will be given to you at that appointment and you will have an opportunity to ask questions. You will also need to have an electrocardiograph (ECG), chest X-ray and blood tests. To check for MRSA, swab samples will be taken from your nose, perineum (between your legs) and any wounds apparent on the skin (for example from leg ulcers). All patients are prescribed an antimicrobial wash (Stellisept) and nasal preparation (mupirocin) with instructions on how and when to use them prior to admission. If your swabs show you are a carrier of MRSA you will be contacted and advice will be given on how to treat this, after which more swabs will be taken to see if the treatment has worked. If you live too far away to attend a pre-admission appointment your tests will be done on admission. 9
Before the procedure (continued) Giving your consent for the procedure You will be asked to give your legal consent by signing a consent form, either when you see the operating cardiologist at your out patient appointment or during your admission(s) for the cardiac catheter or TAVI itself. It is very important that you ask any questions or raise any concerns that are on your mind before signing. During your admission You will be admitted to hospital the day before your procedure and will be seen by an anaesthetist. It is very important that you tell us if you have any allergies. On the day of the procedure you will be asked to have nothing to eat or drink from midnight. All hair will be removed from your groin area, arms and chest. You will be required to shower in an antibacterial wash then dress in a gown. A needle called a cannula will be inserted into the back of your hand. 10
The TAVI procedure You will be taken on your bed to a catheter laboratory. You will be helped onto the table and attached to monitoring equipment. There will be a large number of operators and technicians in the room with you. 1. Most patients will be given a general anaesthetic to put them to sleep. 2. A sheath (a short tube used to introduce catheters) will be placed in both sides of your groin to allow catheter access to your heart through your arteries. Another will be placed on one side of the groin so that a wire can be passed via a vein to the right side of your heart to ensure that your heart beat does not run too slowly. For patients having a transapical implantation there will be a surgical incision approximately 4 inches in length on the lower part of the front of the left side of the chest. Subclavian access patients will have a surgical wound underneath the collarbone. This allows access to the subclavian artery for valve implantation. 3. A special catheter with a balloon mounted on the tip is threaded through one of the arterial sheaths and into your diseased aortic valve. 4. Once the end of the balloon is in the aortic valve, the balloon will be inflated to enlarge your narrowed valve, in order to accommodate the new valve. This is called valvuloplasty. 5. The new valve is then carefully compressed and mounted onto a delivery catheter and threaded inside your existing diseased valve. 6. The new valve is designed to settle in place firmly. 11
The TAVI procedure (continued) 7. Dye will also be injected through the catheter in the other groin to check the positioning of the artificial valve. 8. At the end of the procedure the sheath used for the valve catheter will be removed and the small incision in your groin or chest closed. 9. The arterial sheath will be taken out by a nurse who will then press on your groin for 15 minutes or so. 10. The one remaining sheath in the vein in your groin will probably be removed the next day. This will mean that you will have to stay in bed for at least 24 hours. The entire procedure takes around 1 hour. After the procedure After the procedure you will be taken to recovery for a short period of observation and then on to the cardiac high dependency unit (CHDU) on ward 33 where observation and care will continue under the guidance of the consultant. Pain killers will be given for any post-operative wound discomfort. The following day, if all is well, the final sheath can be removed, which again will require another two hours of bed rest before getting up. Following your initial recovery you will be cared for on a cardiology ward until you are discharged. If there are no complications following the procedure, your hospital stay will normally be between three and five days. However, any problems that occur or are picked up after the procedure are likely to lengthen this period. 12
Going home Your wounds should have healed by the time you go home, but there may be some stitches which will need to be removed later. Your nurse on the ward will provide you with a letter to give to your GP practice nurse or district nurse so that this can be arranged. You will also be seen as an outpatient by the cardiologist approximately six weeks after discharge, where the consultant will monitor the efficiency of the new valve. You may need further tests, such as another echocardiogram, ultrasound scanning of the heart, electrocardiograph or chest X-ray. 13
Your questions Please use this space to note down any questions you might like to ask the nurse or consultant at your appointments. 14
Contact numbers Pre-admission nurse, clinic D 0116 250 2473 TAVI co-ordinator 0116 258 3358 15
If you would like this information in another language or format, please contact the service equality manager on 0116 258 8295 Haddaad rabto warqadan oo turjuman oo ku duuban cajalad ama qoraal ah fadlan la xiriir, Maamulaha Adeegga Sinaanta 0116 258 8295. Eĝer bu broşürün (kitapçıĝın) yazılı veya kasetli açıklamasını isterseniz lütfen servis müdürüne 0116 258 8295 telefonundan ulaşabilirsiniz. Produced: February 2008 Reviewed: June 2011 Review: June 2013 (Dowling)6113815KR CAR002-0611