Years After Fda Approval Bronchial Thermoplasty Remains Controversial
An endoscopic therapy approved by the FDA in 2010 for patients who are suffereing from severe asthma, who have few other therapeutic options, remains highly controversial.
Bronchial thermoplasty, delivered with Boston Scientific’s Alair System, is a novel therapy that involves the delivery of radiofrequency energy to heat the airways in a controlled manner, with the goal of achieving a lasting reduction in airway smooth muscle mass and reducing bronchial hyperreactivity.
The treatment protocol involves three separate bronchoscopic procedures performed several weeks apart, in which a catheter placed inside the bronchoscope delivers a series of temperature controlled bursts of energy used to heat the lungs.
The Alair System received premarket approval from the FDA in 2010 for treating adult patients with severe and persistent asthma that is uncontrolled with existing therapies.
Early in 2015, the American College of Allergy, Asthma & Immunology endorsed the procedure in a statement, and recommended that insurers provide coverage “for those adult patients who meet the stringent requirements.”
But, a 2017 “comparative effectiveness review” of bronchial thermoplasty’s efficacy and safety in asthma patients, led federal health officials to conclude that the “balance of benefits and harms” is still unknown.
Prepared for the Agency for Healthcare Research and Quality, the review found:
Can Surgery Fix Asthma
When common treatment methods aren’t enough to manage your persistent asthma symptoms, it may be time to consider a new surgical technique.
Bronchial thermoplasty was approved by the U.S. Food and Drug Administration in 2010 for use in people whose asthma doesn’t respond to other less invasive measures. This asthma surgery is performed with a special device that delivers heat to the lining of the airways in order to shrink any inflammation there. By opening up the airways, the discomfort that typically occurs with an asthma attack is minimized.
Creating Your Asthma Action Plan
People with asthma have highly individual triggers and responses. Some doctors believe there are actually many asthmas, each with its own causes, risks, and treatments.
If you have asthma, your doctor will work with you to create an asthma action plan that focuses on your own symptoms and the things that seem to trigger them. Asthma. .
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Could You Use A Brain Monitor To Prevent Anesthesia Awareness
Brain monitors have not been shown to provide protection from anesthesia awareness, but dont worry, your anesthesiologist knows what to look for. Monitoring for sweating, tearing, increases in heart rate, breathing, and blood pressure are much more reliable. Brain monitors may provide other valuable information, so your anesthesiologist may use one, but not to prevent awareness.
- How have you responded to previous anaesthesia and operations?
- Have there been any anaesthetic problems in any member of your family?
- What medicines or tablets are you taking?
- Do you have any allergies or sensitivities?
- What are your past and present medical problems?
- What are your smoking and drinking habits?
- Have you had dental work?
- Do you ever have indigestion or reflux?
- Tests you may have a physical examination. Your anaesthetist may order additional tests to supplement those performed on your first visit to day surgery.
- Fasting if there is food or drink in your stomach during and immediately after the anaesthetic, it can be very dangerous. This is why you should not eat or drink anything for several hours before your anaesthetic.
- Anaesthesia your anaesthetist will discuss the appropriate anaesthetic. Sometimes, the anaesthetist arranges for a sedative to be given an hour or so before the operation. This pre-medication will help you feel drowsy and relaxed. You can discuss whether you need this with the anaesthetist.
- Safety you may be asked to remove any false teeth and jewellery.
What Is Anesthesia Awareness
Anesthesia awareness is an unfortunate situation where you are not fully unconscious during the surgery. People with true anesthesia awareness later report that they heard some of what was going on in the operating room. Usually, they cant feel anything, but may be very scared. Rarely, they can feel the surgery but cant move or speak. People who have medical or surgical issues where giving deep anesthesia is dangerous are at more risk for true anesthesia awareness.
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The Hope Of Bronchial Thermoplasty
The clinical data on bronchial thermoplasty has been quite encouraging, although only a handful of hospitals currently have staff trained to perform the procedure. In addition, this technique isn’t appropriate for all asthma sufferers. It’s only meant for people who have severe asthma that isn’t controlled by other methods and who meet certain lung function criteria to ensure the best results.
If your doctor thinks that bronchial thermoplasty is an appropriate option for your situation, you’ll need to understand that like any type of surgery, there are some possible risks involved. This can include a collapsed lung or other respiratory complications.
What Happens During A Treatment
First, your doctor will test your lungs by checking to see how much air you can blow out.
You’ll take a steroid pill and, through a vein in your arm, you’ll get medicine to make you sleepy. You may get other medicine to numb your mouth and throat.
Your doctor will put a small tube called a bronchoscope through your mouth, down your throat, and into your lung. A smaller tube goes inside the bronchoscope and warms each small airway in that part of your lung. The heat is very mild — cooler than a cup of coffee. You won’t feel it or the tube touching your lungs.
After the treatment, you’ll likely rest for 3 or 4 hours. You’ll also do another lung test. Depending on the results, you might spend the night in the hospital. Or you could go home the same day.
A nurse will call you after each session to see how you’re doing. Your doctor will check on your progress closely for 6 weeks after your last treatment.
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Side Effects And Risks
It’s common to feel sleepy right after your treatment. You may also cough or wheeze some, or be short of breath. These symptoms usually go away in a week. In rare cases, you may need hospital care for your symptoms.
There is a risk that the treatment will trigger a bad asthma attack that may even cause you to be hospitalized.
New Asthma Treatment Successful But Costly
Bronchial thermoplasty cleared by FDA but not covered by health insurance.
McLeland, who has had asthma since birth, tried everything her doctors recommended to relieve her asthma, from playing sports to taking the highest dosage of asthma medication.
“It felt like someone’s strangling you,” said McLeland. “It’s scary when you have nowhere else to go and what you’re on is the best you’re going to get.”
In 2007, McLeland enrolled in a clinical trial for an invasive procedure called bronchial thermoplasty. Since then, she hasn’t experienced a single asthma attack.
For hundreds of severe asthmatics who have undergone bronchial thermoplasty the first nondrug treatment for asthma approved by the U.S. Food and Drug Administration in 2010 the results have been life-changing.
“When you’ve lived with it for so long, you learn to adapt to it, but it’s been amazing realizing after the thermoplasty how much I was limited,” she said.
However, the dramatic improvement comes with a hefty price tag.
Bronchial thermoplasty is expensive, costing anywhere from $15,000 to $20,000 depending on the procedure, and most insurance companies won’t pay for it.
The treatment is reserved only for patients for whom medication hasn’t worked. Although five-year follow-up studies have found the procedure to be safe and effective, most insurance companies still consider the procedure experimental.
But the procedure isn’t expected to rid patients of medications completely.
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Induction And Intraoperative Management
Adequate depth of anesthesia is required to prevent bronchospasm and reduce the response to tracheal intubation. Severe bronchospasm may cause fatal or near-fatal events such as irreversible brain damage due to inability to ventilate. Deep level of anesthesia can be achieved through a combination of appropriate IV anaesthetic agents, ultra short acting opioids and volatile agents prior to instrumenting the airway, as tracheal intubation during light levels of anesthesia can precipitate bronchospasm .
Among the intravenous anaesthetic agents propofol and ketamine have bronchodilation effect. Propofol is the induction agent of choice in the hermodynamically stable patient due to its ability to attenuate the bronchospastic response to intubation both in asthmatics and non-asthmatics , , ]1b. A systematic review showed that Ketamine is an ideal induction agent for hermodynamically unstable asthmatics patients due to its ability to produce direct smooth muscle relaxation and bronchodilation without decreasing arterial pressure or systemic vascular resistance 1a.
Studies indicated that volatile anesthetics especially halothane, isoflurane and Sevoflurane are excellent choices for general anesthesia, as they depress airway reflexes and produce direct bronchial smooth muscle relaxation 2a. However, desflurane which causes irritant to airway apparatus and increases airway resistance should be avoided in asthmatics , , ]1b .
What Kind Of Medicine Is Involved
Asthma treatment serves two main purposes: long-term control and short-term symptom relief. Here are some of the asthma drugs your doctor could include in your asthma action plan:
Inhalers. These portable devices deliver a premeasured dose of asthma medicine into your lungs. You hold the J-shaped pumps to your mouth and press down on the canister. The pump sends out a mist or powder that you inhale.
Some inhalers contain corticosteroids that control swelling and irritation in your airways. These inhalers are for daily or seasonal use.
Other inhalers contain fast-acting drugs that can open your airways quickly if youre having an asthma flare-up.
Some inhalers may contain a combination of medicines to control your precise reactions.
Nebulizers. These freestanding devices turn liquid medicine into a mist you can breathe. The drugs used in nebulizers reduce swelling and irritation in the airways.
Oral medicines. Your long-term action plan may also include oral medications. Oral asthma drugs include leukotriene modulators and theophylline which opens your airways. Both are taken in pill form. Oral corticosteroid pills are also sometimes prescribed.
Biologics. You may have an injection of a biologic medication once or twice a month. These medicines are also called immunomodulators because they reduce certain white blood cells in your blood or reduce your sensitivity to allergens in your environment. Theyre only used for certain types of severe asthma.
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Take Action If Your Asthma Symptoms Get Worse During Pregnancy
The sooner you get help the quicker you can cut the risks to you and your baby. So talk to your GP, asthma nurse, midwife, or pharmacist if you notice any of the following:
- Youre coughing or wheezing more especially at night.
- Your chest feels tight
- Youre taking your reliever inhaler more often. If youre taking your reliever inhaler three or more times a week, you may be at risk of an asthma attack and should get an urgent GP appointment.
- Your nose feels stuffy This is a common pregnancy symptom. But it could also affect your asthma. If your nose is stuffy youre more likely to breathe through your mouth instead. This means the air doesnt get warmed up before it hits your airways. And allergens cant be filtered out as well.
- You feel more breathless. Getting a bit breathless more than usual is another common pregnancy symptom. But dont ignore it. Its also a sign your asthma is getting worse.
- Your hay fever gets worse. Hay fever or pollen allergy can make your asthma symptoms worse so its important to treat it. Ask your GP or pharmacist about which hay fever treatments are safe for you to use during your pregnancy. Its likely that youll be recommended eye drops or nasal sprays first. You can also try other ways to relieve hay fever symptoms.
- You have acid reflux this is common in pregnancy and can make your asthma worse.
What to do if youre having an asthma attack
Is Surgery Dangerous If You Have Asthma
If your asthma is optimally controlled the risk is very small and you can undergo major surgery without significant asthma complications. Most anesthesiologists I have worked with will recommend that you take your asthma medicine the prior to surgery with a sip of water and bring your inhalers to the surgery center. In addition, steroids are given just prior to anesthesia in most patients any way which helps prevent asthmatic complications.
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Why Do You Say True Anesthesia Awareness
There are many, many cases when people think they have been awake during general anesthesia, but in fact, they are mistaken. The most common scenario involves a surgery where they had sedation anesthesia or sedation in combo with a spinal, epidural, or regional anesthetic. Those types of anesthesia do not and are not supposed to induce unconsciousness. It is absolutely normal to have memories and be at least partially awake with these types, but memories may be fuzzy due to the drugs used.
There are several things to consider when youre planning surgery. If you have asthma, an increased risk of certain surgical complications because of your condition is one of them. Having severe asthma or experiencing asthma-associated issues in the weeks or months before surgery further increases the likelihood of developing an adverse event, such as an infection, after your procedure.
To reduce your chances of complications, your pre-operative evaluation will include an assessment of your asthma control and lung function. Your surgery and surgical anesthesia will need to be planned with your asthma status in mind.
Verywell / Ellen Lindner
Is Dental Anesthesia Safe For Patients With Mild Asthma
Truly, asthmatics are in danger of specific complication because of their asthma. But your real issues rely upon the seriousness of your asthma, the measure of hyperresponsiveness, and the sort of anesthesia being utilized. If you have asthma and you worry about going through a dental procedure under anesthesia, here are some useful information from to answer your concern.
In the event that you have steroid-depending mild asthma or ineffectively controlled asthma, you should see your asthma specialist before a medical procedure. The prior the better, around seven days ahead of time in the event that your medication needs change. Unfortunately, control of asthma does not generally foresee the danger of intricacies amid medical surgery as various patients with what seems, by all accounts, to be great control may create difficulties intraoperatively.
In any case, doctors are dealing with problems which might arise in case patients are administered for general anesthesia. The doctors thinks that with a varying focus from treatment to numerous past examinations talking about the dangers and complications are not as substantial today. Most patients will experience general anesthesia without issue, its as yet worth talking about with your specialist before a medical procedure.
Dangers of anesthesia
What is sleep apnea?
How does sleep apnea affect anesthetic risk?
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New Surgery To Treat Asthma
Asthma has complicated Todd Anderson’s life ever since he was 3 years old. Doing sportseven stairshad been difficult. Cigarette smoke, pollen, disinfectants or a passing whiff of perfume could set off a severe asthma attack. “It feels like your chest is clenching up like a fist,” says Mr. Anderson, a 29-year-old music teacher in the New York City schools.
Todd Anderson undergoes a pre-treatment test at Beth Israel Medical Center in New York.
Last summer, he heard about a new procedure called bronchial thermoplasty that opens constricted airways permanently. He had the third and final stage of the procedure at New York’s Beth Israel Medical Center two weeks ago and says he’s already feeling better. “Somebody near me on the train was wearing cologne. Normally, I’d need to take a couple of puffs on my rescue inhaler, but I didn’t have to do that,” Mr. Anderson says.
About 22 million Americans suffer from asthma, an inflammation of the airways in the lungs that causes coughing, wheezing and shortness of breath. It can range in severity from an occasional annoyance to a chronic, life-threatening condition exercise, allergies and airborne dust or other irritants can set off attacks.
Most asthma medications work by reducing that “twitchiness,” Dr. Erzurum explains. Bronchial thermoplasty uses radiofrequency waves to shrink the smooth muscle itself, a new approach to treating asthma symptoms.
‘I Could Breathe’
Write to Melinda Beck at
What Further Increases Your Risk
While any degree of asthma increases the chances that you could have a postoperative complication, there are certain circumstances that can raise the risk even further:
- Extent of your procedure: Generally, major procedures are riskier than minor surgeries when you have asthma.
- Severity of your asthma: Severe asthma is a greater risk factor for surgical problems than mild or moderate asthma.
- Degree of asthma control: If your asthma isn’t well-controlled, your risk of adverse post-surgical events increases. You could have poorly controlled asthma if you aren’t taking your medication as directed, your medication isn’t right for you, or you cannot avoid exposure to certain triggers.
- Steroid use: Asthma that requires very high doses of steroids is associated with a high chance of postoperative complications.
- Health before surgery: Frequent asthma attacks or infections in the months prior to surgery are predictors of worse outcomes after surgery.
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General Anesthesia: What You Need To Know
For some procedures and surgeries, you may have a choice regarding the type of anesthesia used. Many times, though, the only good choice will be general anesthesia.
In this article I will give you a broad introduction to terminology, procedure, and what to expect.
General anesthesia means loss of consciousness.
If you are under with general anesthesia, you cannot feel, see, or hear anything, and you do not respond to even painful stimuli.