Edwards Lifesciences Devices Placed On The European Market Meeting The Essential Requirements Referred To In Article 3 Of The Medical Device Directive 93/42/eec Bear The Ce Marking Of Conformity
Indication:
Edwards transcatheter aortic heart valves are indicated for relief of aortic stenosis in patients with symptomatic heart disease due to severe native calcific aortic stenosis who are determined by qualified practitioners to be at specific risk for open surgical therapy. Patients should talk with their physicians to determine whether they are eligible for the transcatheter heart valve procedure and which transcatheter heart valve may be appropriate for them.
Contraindications :
Transcatheter aortic valve implantation should not be performed on patients who:
- Cannot tolerate medications that thin the blood or prevent blood clots from forming.
- Have an active infection in the heart or elsewhere.
- Are allergic to the materials in some valves
Warnings:
Precautions:
The long-term durability of the transcatheter heart valves is not known at this time. Regular medical follow-up is recommended to evaluate how well a patients heart valve is performing.
The safety and effectiveness of the transcatheter heart valve is also not known for patients who have:
Potential risks associated with the procedure include:
Additional potential risks specifically associated with the use of the heart valve include:
CAUTION: These devices are restricted to sale by or on the order of a physician.
What Is The Most Common Complication After Open
How To Take Care Of Your Chest Incision Site After The Surgery
Once the surgery is done, the patient has to stay in the hospital for few days for observation in order to ensure the success of the surgery. The patient mostly has to follow the doctors instructions then, while the nurses are going to take care of the incision site. It is important to discuss the methods of caring the incision site at home after discharge.
- Most of the doctors may recommend the patient to go for bed bath because in open heart surgery the incision point is quite big.
- Vigorous scrubbing of the incision point should be avoided.
- Surgical dressing of the chest incision should be done regularly.
- The incision site should not be directly exposed to sunlight for a year because it is easily prone to sunburn.
- Applying any kind of creams, oil or lotion on the incision should be avoided unless the doctor feels okay to do so.
- In case of any symptom of injection of the incision site like swelling, redness or even fever, it should be informed to the doctor as early as possible.
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Resuming Normal Activities After Open Heart Surgery
Its important to remember that not everyone heals at the same rate. People who have diabetes or are taking steroids may take longer to heal after surgery. Age can play a role, too, as recovery may take longer in adults who are older. Complete recovery takes about three to six months.
At any phase in your recovery, using common sense is the best way to keep yourself from overdoing it, Dr. Tong says.
If an activity causes pressure or pain, stop. If your sternum doesnt heal properly after surgery, it can cause you a lot of pain and complicate the healing process.
If you arent sure an activity is safe, check with your surgeon first. And contact your doctor right away if you experience:
- Redness on your chest larger than a quarter or drainage that resembles pus. This might signal an infection.
- A clicking noise in your chest when you cough or breathe deeply. This could mean the wire holding your sternum together has broken.
- Abnormal pain.
Overall, give yourself time to heal, while gradually doing a little more each week. Continue to work with your doctor until youre up to speed on your normal activities.
What Is The Fastest Way To Recover From Bypass Surgery
The fastest way to recover is to be patient with yourself. Take time to return to a normal routine dont try to rush it. Know that your cardiac care team cares about your recovery and is available to help you through this process.
Perhaps one of the most important steps to recovery is your outpatient cardiac rehabilitation program. This usually starts a few weeks after surgery. It includes guidance on exercise, nutrition, and lifestyle all the keys to heart health after CABG. The program is supervised by therapists who are specially trained to care for people with heart conditions.
In general, cardiac rehab programs last at least six weeks. But the length can vary depending on your needs. Its common to think its unnecessary or even too time-consuming. But we cant stress enough how important it is. Please speak with your care team if you have financial or other concerns.
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Taking Care Of Their Recovery
The six to eight weeks after open-heart surgery can be the most challenging, but healing time depends on many factors like your health prior to surgery, and how well the patient cares for themselves during recovery.
In general, you or your loved one will have multiple follow-up appointments so make sure that the support system or caregivers are aware of the dates and locations of appointments to assist. The patient’s discharge plan may or may not be similar to others, so its good to have everyone interested in their care on the same page!
As for the incision, its very important to follow the discharge instructions regarding care. Its normal for some straw-colored fluid to be discharged during healing, but make sure that the patient or caregiver contacts the doctor if they experience redness, warmth, puffiness, a change in the drainage, pain or tenderness, or a fever above 100°F. This could be an indication of a possible infection anywhere from several days to even weeks after discharge.
Patients may also experience a clicking sensation in the sternum that can be quite alarming, but keep in mind that the sternum bone is also healing and this will take time. If the patient experiences acute tightness, pulling, clicking, or grinding sensation they should cease the activity that brought it about and contact your doctor if it continues or becomes unbearable.
Managing Pain After Open Heart Surgery
Managing your pain is an important part of your recovery after heart surgery. In addition to keeping you comfortable, pain control can help speed your recovery and reduce your risk of developing certain complications after surgery, like pneumonia and blood clots. Your pain level should be managed to the point that youre able to get up, walk around, cough and take deep breaths after surgery.
After heart surgery, you need to be able to move with some degree of comfort to aid the healing process, Dr. Tong says. Keeping your pain level manageable will help make sure your recovery stays on track.
You may leave the hospital with a prescription for pain medication and detailed instructions on how to use those medications to manage your pain.
People are often apprehensive about taking narcotic pain medications because of the risk of addiction, Dr. Tong notes. That is a healthy and very reasonable fear and an important conversation to have with your doctor. There are safeguards in place to stem opioid abuse and protect you from abusing medications. When it comes to prescription pain medication, for most people, its a matter of listening to your body. If you need it, take it. If you dont, dont.
If you have concerns about bringing narcotics into your home, or if you have a history of substance use disorder, be honest with your doctor. Theyll be able to discuss your options with you and determine a pain control plan with you.
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General Condition Of Patient
The overall health of the patient has a great deal to do with the healing process. There are many variables that impact the ability to recover quickly, such as the presence of diabetes and the patients smoking history.
The patient who goes into surgery with a complex history of illness is unlikely to heal as quickly as the patient who has the same surgery with no history of illness.
The patient who smokes is more likely to have scarring and delayed wound healing, while the diabetic surgery patient is at higher risk for infections postoperatively. These things play a role in how healing will progress. The patient can speed their healing process by quitting smoking, the diabetic can promote their recovery by keeping their blood glucose level well-controlled, so it is possible to manage these issues before and after surgery.
Is Open Heart Surgery Safe For The Elderly
For many years, performing open heart surgery on elderly patients was considered too risky as an increase in age is associated with increased risks of negative outcomes following surgery. However, as surgical techniques have advanced and patient care especially for octogenarians has improved, more and more surgeons are feeling comfortable recommending open-heart surgery for their elderly patients. In fact, in 2008, a study of more than 1000 patients aged 80+ indicated that operative mortality rates had been reduced from 15% to 2.2%, with more than 97% of participants reporting an improved quality of life following their procedures.
Of course, this doesnt mean open heart surgery is completely safe for the elderly rather, it simply suggests old age should not be a disqualifying factor in and of itself for these procedures. Doctors should consider the fact that individuals aged 80+ do tend to suffer from a higher number of risk factors or comorbidities that may increase the risks associated with undergoing open-heart surgery. Some of these risk factors or predictors of a poor outcome in the elderly include:
- Preoperative: diabetes mellitus recent myocardial infarction, renal dysfunction, obesity, COPD , smoking, and being of female gender.
- Intraoperative: experiencing a long cardiopulmonary bypass time or undergoing emergency operation or reoperation.
- Postoperative: atrial fibrillation or post-operative bleeding.
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Caring For Your Wound
The metal wires holding your breastbone together are permanent.
But the stitches closing your skin will gradually dissolve over the weeks following surgery as your skin heals.
While you’re recovering in hospital, you’ll be told about how to care for your wounds at home.
It’s important to keep the wounds clean and protect them from the sun while they’re healing.
You’ll have a scar where the surgeon cut down your chest, as well as where the grafted blood vessel was taken from.
These will be red at first, but will gradually fade over time.
Remember To Move Carefully
- Rapid change of position may be accompanied by dizziness if done to quickly.
- Rest whenever you get tired.
- Rest between activities. If you need to rest for more than one hour after an activity, you may be pushing yourself too hard. Do a little less the next day.
- Avoid placing undue strain on your chest region by sitting in one position for long periods of time.
- When sitting or standing, use your leg musclesdo not use your arms to lower or raise yourself from your chair.
- Do not cross your legsit interferes with blood flow.
- Pace yourself.
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Youll Play A Key Role In Managing Your Pain
Post-surgical pain is unavoidable but can be managed in a variety of ways. Because of recent national legislation changes, physicians can prescribe no more than a seven-day supply of opioids to patients at the time of their hospital discharge.
Weaning yourself off opioids as soon as possible is important. You may need less than a seven-day supply, depending on your condition. Some patients do not require any opioids for pain management.
Other options for pain management include:
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Oral and topical analgesics such as acetaminophen and Salonpas patches
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Applying a warm cloth to the area, using caution near the incision because nerve sensitivity may be decreased, causing the skin to burn
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Relaxation techniques such as meditation and guided imagery
If you are on long-term opioids, you should meet with your prescribing physician to begin to wean down to the lowest dose possible before surgery.
Getting Back To Normal Life
After open-heart surgery, life will never be quite the same in fact, it might be even better! As the patient continues to heal, their doctor and other individuals involved with care will be able to recommend when they will be able to start exercising, traveling, returning to work, or taking on more strenuous recreational activities. If you are someone who is caring for a loved one after open-heart surgery, one of the most important things you can do is encourage walking , a daily routine, personal care, and self-care for yourself as well.
If you are feeling hesitant about the stability of the incision or would benefit from some peace of mind as a caregiver, you may want to consider discussing a support harness or post-operative bra. The support and comfort that can come from either of these great options can help speed your recovery by reducing your anxiety, your perception of pain and stabilizing your incision and sternum as well.
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What Should You Avoid Doing After Having Cabg Surgery
Your body needs quite a bit of time to heal after a major surgery like CABG. Its important to follow your care teams instructions and ask them when you have questions. They will likely advise you to avoid certain activities while you recover, some of which may include the following:
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It takes time for the sternum to heal. So for at least a couple of weeks after surgery, most people should avoid lifting, pushing, or pulling more than 10 pounds.
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You should also limit use of your arms to simple everyday tasks like getting dressed and playing cards. In other words, dont lift your arms above your head or behind your back.
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Dont drive for the first 2 to 3 weeks. This helps avoid injuring your chest, but its also because you may still be on pain meds and not feeling 100% yet.
Six Weeks To Three Months
After six weeks, youll be largely recovered and youll then be able to resume heavier housework and gardening, business or recreational travel, aerobic exercises without weights, driving, and dog walking.
The expectation, more or less, is that you can start moving towards pre-operation levels of activity. That said, dont push it and seek out your healthcare providers clearance if you want to try anything more strenuous or new.
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Sleeping Can Be Hard After Surgery
Its hard to find a comfortable position to sleep in. If you are a side or belly sleeper it can be hard laying on your back. Finding your favorite chest pillow will be your savior. You might also experience nightmares for a bit after surgery, but it will pass. If you continue to experience them, speak to your doctor and seek help if you feel like you are experiencing PTSD.
Is Full Recovery Possible
Is it possible or reasonable to make a full recovery? What exactly is a full recovery? The idea of a full recovery is typically understood as functioning as well as prior to surgery, or better. That expectation may not be reasonable, a better definition might be reaching your best possible level of function after surgery. Some surgeries are not performed for a cure, but to improve pain, remove infection, or slow a disease process.
For example, imagine a patient who has a severe infection in their foot that is both painful and life-threatening. The problem is not being controlled by antibiotics or wound care, and the infection is threatening to move to the rest of the body. Surgically removing the foot could very well save the patients life, and put an end to the infection however, walking will be a very different thing after surgery, potentially requiring a prosthetic foot. For this patient, a return to good health without an infection, and a well-healed incision may be considered an outstanding outcome and a complete recovery.
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What Happens After Open
When you wake up after surgery, you will have two or three tubes in your chest. These are to help drain fluid from the area around your heart. You may have intravenous lines in your arm to supply you with fluids, as well as a catheter in your bladder to remove urine.
You will also be attached to machines that monitor your heart. Nurses will be nearby to help you if something should arise.
You will usually spend your first night in the intensive care unit . You will then be moved to a regular care room for the next three to seven days.
Taking care of yourself at home immediately after the surgery is an essential part of your recovery.
You May Feel Like Youre On An Emotional Roller Coaster
Recovering from open-heart surgery involves physical and emotional healing. The recovery process uses emotional and physical energy.
If you feel upset or emotional in the weeks after your operation, dont worry this is a normal reaction. Many patients report these feelings up to three months after the operation:
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Mood swings that may include depression, fear, anxiety, loneliness, helplessness and anger
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Crying easily for no apparent reason
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Lack of energy or motivation
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Getting easily frustrated
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Having good days and bad days
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Feeling more emotional or sentimental than normal
Even though you may feel drained physically and emotionally, its important to follow guidelines for good self-care:
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Get dressed every day
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Walk daily within your limits
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Get plenty of rest
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