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All about pacemakers and how they work.

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What is a pacemaker?

A small battery-operated device that helps the heart beat in a regular rhythm. There are two parts: a generator and wires (leads).

The generator is a small battery-powered unit.

It produces the electrical impulses that stimulate your heart to beat.

The generator may be implanted under your skin through a small incision.

The generator is connected to your heart through tiny wires that are implanted at the same time.

The impulses flow through these leads to your heart and are timed to flow at regular intervals just as impulses from your heart's natural pacemaker would.

Some pacemakers are external and temporary, not surgically implanted.

View an animation of a pacemaker.

Why do I need one?

Your doctor may recommend a pacemaker to make your heart beat more regularly if:

Your heartbeat is too slow and often irregular.

Your heartbeat is sometimes normal and sometimes too fast or too slow.

How does it work?

It replaces the heart's defective natural pacemaker functions.

The sinoatrial (SA) node or sinus node is the heart's natural pacemaker. It's a small mass of specialized cells in the top of the right atrium (upper chamber of the heart). It produces the electrical impulses that cause your heart to beat.

A chamber of the heart contracts when an electrical impulse or signal moves across it. For the heart to beat properly, the signal must travel down a specific path to reach the ventricles (the heart's lower chambers).

When the heart's natural pacemaker is defective, the heartbeat may be too fast, too slow or irregular.

Rhythm problems also can occur because of a blockage of your heart's electrical pathways.

The pacemaker's pulse generator sends electrical impulses to the heart to help it pump properly. An electrode is placed next to the heart wall and small electrical charges travel through the wire to the heart.

Most pacemakers have a sensing mode that inhibits the pacemaker from sending impulses when the heartbeat is above a certain level. It allows the pacemaker to fire when the heartbeat is too slow. These are called demand pacemakers.

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A small battery-operated device that helps the heart beat in a regular rhythm. There are two parts: a generator and wires (leads). The generator is a small battery-powered unit. It produces the electrical impulses that stimulate your heart to beat. The generator may be implanted under your skin through a small incision.

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A cardiac PaceMaker is a small device that is operated, this device senses when your heart is beating slowly or irregularly This device sends a signal to someones heart for it can have a healthy and correct heartbeat. Usually when someone has a pacemaker it means that their heartbeat isn't functioning correctly as it should be, this can help treat patients with heart failure. Those who need a pacemaker usually have arrhythmias, arrhythmias is when the heartbeat is irregular,too slower, too fast, this occurs when the electrical impulses in the heart doesn't work correctly, there are other reasons why people need a pacemaker due to heart blockage, heart attacks, atrial fibrillation. This will change someones lifestyle such as their diet, driving, exercising, and quit smoking. Most people who had a pacemaker implanted may need to avoid heavy lifting for at least one month.  

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A cardiac PaceMaker is a small device that is operated, this device senses when your heart is beating slowly or irregularly This device sends a signal to someones heart for it can have a healthy and correct heartbeat. Usually when someone has a pacemaker it means that their heartbeat isn't functioning correctly as it should be, this can help treat patients with heart failure. Those who need a pacemaker usually have arrhythmias, arrhythmias is when the heartbeat is irregular,too slower, too fast, this occurs when the electrical impulses in the heart doesn't work correctly, there are other reasons why people need a pacemaker due to heart blockage, heart attacks, atrial fibrillation. This will change someones lifestyle such as their diet, driving, exercising, and quit smoking. Most people who had a pacemaker implanted may need to avoid heavy lifting for at least one month.  

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When People Get Animal Parts

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Xenotransplantation: When People Get Animal Parts

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Summary of Article/Video that includes function.

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Summary of Article/Video that includes function.

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This video describes what xenotransplantation is - the transfer of tissue/organs from one species to another. It also details some specific examples like pig kidneys for human subjects - that show how useful and lifesaving this innovation could be if we went further with it.

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A picture I can use to help me remember what my innovation is. 

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A picture I can use to help me remember what my innovation is. 

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new drug improve osteoprosis

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New Drugs Improve Osteoporosis Treatment

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UC Davis Health surgeons are known throughout the U.S. for their leadership in robotics, the latest development in minimally invasive surgical technology. Robotic-assisted surgery is offered in several specialties, including gastrointestinal, cardiothoracic, gynecologic oncology, otolaryngology (head and neck) and urologic surgery. Each procedure is performed by a highly experienced and skilled team of surgeons, nurses and technicians who are specially trained to use robotic surgical systems.

Benefits to surgeons and patients

The key differences of using robotic systems for surgeons are improved, 3D visualization and precision control of surgical instruments. The technology can be ideal for certain delicate or complex surgeries, because it makes it easier for surgeons to avoid surrounding nerves and organs.

For patients, robotic surgery offers several potential benefits over conventional open surgery, including:

Less pain and use of pain medication

Less blood loss

Less risk of infection

Less scarring

Shorter hospital stays

Shorter recovery time

How robotic-assisted surgery works

UC Davis Health surgeons have access to the latest da Vinci XI and SP robotics systems. Our spinal neurosurgeons use the ExcelsiusGPS system.

With da Vinci systems, the surgeon sits at a control console near the patient while an assistant surgeon is at the patient's bedside. Procedures involve very small, keyhole-sized incisions (with SP, just one incision) through which a tiny camera and surgical instruments are placed. The surgeon sees the operative field through a video monitor and manually controls robotic arms that replicate movements of the surgeon's hands.

The ExcelsiusGPS robotic navigation system is alongside the patient's bedside together with the surgeon. The system links imaging with precision alignment technology for procedures that involve placing screws to improve spinal stability.

Working with patients to decide if robotics is right for them

As with all surgical procedures, outcomes of robotics surgeries cannot be guaranteed. Your physician will discuss the risks and benefits of treatment options with you.
Learn more about da Vinci surgical systems " Learn more about the ExcelsiusGPS system " Learn more about our robotic surgery specialties "

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UC Davis Health, Public Affairs and Marketing

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Robotic-Assisted Surgery | Surgical Services | UC Davis Health

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UC Davis Health surgeons are known throughout the U.S. for their leadership in robotics, the latest development in minimally invasive surgical technology. Robotic-assisted surgery is offered in several specialties, including gastrointestinal , cardiothoracic , gynecologic oncology , otolaryngology (head and neck) and urologic surgery.

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osteoporosis is s desies that may cause disabilities because of the bone thining, its important for the patients to know the symptoms about this desies because this disease has no symptoms, put it is preventable. over time their has been more treatment for osteoporosis, theirs injectible medications such as fortao which will help the increasment of the bone and increase its mass. you bcan also eat broucaly and milk that would help. this is life changing because it will encurige you to stsrt exersizing and to talk about your diet. for older patient its incuriged to have them attend physical therapy to prevent falling by optimizing their muscle strength

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osteoporosis is s desies that may cause disabilities because of the bone thining, its important for the patients to know the symptoms about this desies because this disease has no symptoms, put it is preventable. over time their has been more treatment for osteoporosis, theirs injectible medications such as fortao which will help the increasment of the bone and increase its mass. you bcan also eat broucaly and milk that would help. this is life changing because it will encurige you to stsrt exersizing and to talk about your diet. for older patient its incuriged to have them attend physical therapy to prevent falling by optimizing their muscle strength

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The technology can be ideal for certain delicate or complex surgeries, because it makes it easier for surgeons to avoid surrounding nerves and organs. Also how is less pain and etc..

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Closed Loop Spinal Cord Stimulation Proving More Effective at Relieving Pain

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Closed Loop Spinal Cord Stimulation Proving More Effective at Relieving Pain

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Since the first medical neuromodulation procedure was performed in 1967 in Australia by Dr. Norman Sheely, pain specialists, researchers and industry have been working to improve and perfect this treatment modality.

Today, more than half a century later and dozens of iterations in technology, closed-loop stimulation is a breakthrough that has great potential for helping patients manage their pain. Nagy Mekhail, MD, PhD, Director of Evidence-based Pain Management Research at the Cleveland Clinic's Department of Pain Management, has practiced many therapies over the years and is excited by the promise of closed-loop spinal cord stimulation (SCS).

"Neuromodulation has been used for many pain conditions, but it has had its limitations," Dr. Mekhail says. "Patient feedback from the preliminary study done in Australia, is telling us that the most recent advances in the technology provide great hope for patients with chronic pain conditions, compared with previous neuromodulation technologies we have used."

The evolution of neurostimulation over the past 50 years has gone through many phases. Starting with unipolar stimulation of nerves, pain specialists moved to spinal cord stimulation with multiple leads using the following fixed-input technologies:

Dual leads / Tripolar leads / Paddle leads

Constant current / Constant voltage

Wave forms: "Tonic" / Burst / Multi wave platform

High frequency of stimulation ("HF10")

Most recently, spinal cord stimulation has been used to provide pain reduction and improve functional capacity and quality of life for patients with complex regional pain syndromes, failed back surgery syndrome and other neuropathic pain syndromes. The most recent randomized control trials throughout the 2000s have shown that these therapies have failed to achieve long-term results. Dr. Mekhail notes that more vigorous study designs have been needed to establish evidence‐based applications of neuromodulation therapy in emerging indications of pain management.

Studies looking more closely at the effectiveness of these technologies and methods have shown a 50-50 response from patients at best, and even when patients reported some therapeutic pain relief, it was very limited. "There has been no way of knowing the real dose of the stimulation. With all the new advancements in technology, we assumed we knew better, and sometimes we were correct and other times the new technologies did not work as well," says Dr. Mekhail.

He says that fixed-input spinal cord stimulation systems may drive patients to utilize sub-therapeutic electrical doses due to overstimulation events. "When we ask patients how they feel, they would say they felt a sensation, yes, but not necessarily pain relief," Dr. Mekhail says. "And the studies showed that it diminishes by 70 percent over time and there is no relief."

"In hindsight, we missed with these technologies," says Dr. Mekhail. "We accepted the uncertainty and patients didn't get the relief we expected." In fact, in 2017, the global market showed about 100,000 spinal cord stimulators implanted annually, with about 25 percent of them having unsatisfactory outcomes over time, which frustrates patients and costs millions of dollars.

Closed-loop technology

Closed-loop feedback technology was introduced in 2013. The idea came from electrophysiologic studies on the spinal cord neurons, which record the evoked compound action potential (ECAP), representing the synchronous firing of a population of electrically stimulated nerve fibers. This technology allows the SCS device to communicate with the spinal cord neurons and adjust the dose of stimulation accordingly.

Dr. Mekhail explains that it delivers and maintains a therapeutic electrical dose while preventing over stimulation of the dorsal column. Today, when patients have crossed over to closed-loop control, they utilize the appropriate stimulation dose for the neurons and pain relief was maintained at a therapeutic level 90 percent of the time.

"This is a unique way of dealing with the nervous system. The device is listening to the neurons of the spinal cord. It is interacting with the living nerve structure and this makes it much more effective," Dr. Mekhail explains. "With closed-loop stimulation, we are seeing a 93 percent improvement in chronic pain - this is marvelous. The beauty of this is that there is always contact between the stimulator and the nerves."

Today, closed-loop spinal cord stimulation has proven efficacy in neuropathic pain. Dr. Mekhail is performing SCS for neuropathic pain and says his patients are getting measurable pain relief, they are sleeping better and taking less medication.
Dr. Mekhail is the Director of Evidence-based Pain Management Research at the Cleveland Clinic's Department of Pain Management.

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Closed Loop Spinal Cord Stimulation Proving More Effective at Relieving Pain

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Since the first medical neuromodulation procedure was performed in 1967 in Australia by Dr. Norman Sheely, pain specialists, researchers and industry have been working to improve and perfect this treatment modality. Today, more than half a century later and dozens of iterations in technology, closed-loop stimulation is a breakthrough that has great potential for helping patients manage their pain.

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It talks about creating a vital organ without rejection

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Why transplant an organ when you can grow yourself a new one?

This research isn't something that might happen in the distant future. It's being used today to grow fresh organs, open up new ways to study disease and the immune system, and reduce the need for organ transplants. Organ-farming laboratories are popping up across the planet, and showing impressive results. Here we look at the state of the union of a rapidly advancing field called tissue engineering: what's been accomplished so far, and what's right around the corner.

Patients who undergo organ transplants require loads of toxic drugs to suppress their immune systems; otherwise their body might reject the organ. But tissue engineering could make organ transplants a thing of the past. By using a patient's cells to grow new types of tissue in the lab, researchers are finding new ways to custom-engineer you new body parts by using your own cells.

At the cutting edge of organ engineering is Tengion, a clinical-stage biotech company based outside of Philadelphia. Their most successful research to date led to the creation of the Neo-Bladder. Tengion takes some of your cells and grows them in culture for five to seven weeks around a biodegradable scaffold. When the organ is ready, it can be transplanted without the need to suppress the patient's immune system (because the organ was grown from the patient's own cells, it carries no risk of rejection). Once the organ is in, the scaffold degrades and the bladder adapts to its new (old) home.

The Tengion Neo-Bladder is in Phase II testing, meaning that they have already implanted the organ into individuals and studied how the body adapts to it. After 5 years, the company was able to show that the homegrown organs are safe and effective, capable of treating the bladder effects of spina bifida (a neural tube defect that effects bladder function, among other things). After another round of Phase II trials, Tengion will move on to Phase III testing; after that, the Neo-Bladder should be approved and be made commercially available.

Tengion's Neo-bladder is nearing the completion of its clinical trials, but they weren't the first to grow one. If anyone on Earth deserves the job title "Organ Farmer," it's Dr. Anthony Atala. He and his research team at Wake Forest University Medical Center pioneered the world's first lab-grown bladder, and they remain at the forefront of the organ-growing field (Atala is also the chairman of Tengion's scientific advisory board). Wake Forest is the world's largest regenerative medicine research center, and their current research is growing 22 different types of tissue: heart valves, muscle cells, arteries, and even fingers.

So how many different types of human organs have been grown and transplanted? The lab-grown bladders are among the only transplants of an entire organ, but a wide variety of partial organ transplants have taken place. Skin cells are regularly grown in culture and grafted onto patients' bodies. A graft was grown from a patient's trachea cells and transplanted to replace part of her airway that had degraded due to disease. Cartilage has been grown and transplanted into a patient's knee.

A number of technologies are under development but have yet to be transplanted into human bodies. Recently, Dr. Nicholas Kotov and his lab at the University of Michigan have engineered artificial bone marrow, a task that was previously doomed to failure. Kotov and his colleagues realized that in the body, stem cell differentiation relies on chemical signals in three dimensions (whereas in a petri dish, it takes place in two dimensions). This insight led to a new methodology that more closely replicated the natural environment of stem cell differentiation in bone marrow tissue. The resultant homegrown marrow grew and divided normally, even releasing antibodies in fight off an introduced influenza strain. It can be used to study the role of bone marrow in fighting disease within the body, as well as creating a "bioreactor": harnessing the artificial marrow within a device to grow cells and tissues.

Tengion is pretty busy these days as well. Their new website lists a variety of new applications on the horizon, including a Neo-Kidney augment, artery replacements (including in the heart), and variations on their bladder technique to replace cancerous organs. Their company pipeline gives a general idea of the relative stages of each project.

A number of initiatives are under way to create an artificial pancreas, which would revolutionize the way we treat diabetes. By providing diabetics with a healthy pancreas, doctors could restore their natural control of blood glucose by giving them an endogenous source of insulin. Anyone with experience of diabetes knows the difficulty of manually monitoring and controlling your sugar levels, not to mention regularly injecting insulin. A lab-grown pancreas replacement would be an incredible benefit to the 23.6 million individuals in America alone who suffer from diabetes.

As we previously reported, researchers at the University of Minnesota grew an entire rat heart in a laboratory last year. Their next goal is to grow a pig heart, a significant milestone towards growing a human heart due to their similar structure. Researchers hope to combine the scaffold of a pig heart with human cardiac tissue to grow a hybrid heart suitable for transplant.

Another exciting frontier is the field of printable tissue and organs, which is just what it sounds like. Inkjet cartidges are cleaned out and loaded with a mixture of live human cells and "smart gel." Then, layer by layer, the cells are printed atop one another until a 3D organ is constructed. Just as a normal printer can deposit different colored ink, organ printing allows scientists to specify where to place different cell types. Organ printing has already created beating cardiac cells, and could soon produce organs that are viable for transplant. But unlike other 3D printers, I wouldn't want this one in my living room.

The hottest areas in tissue growth are the types hardest to make: nerve, liver, kidney, heart and pancreas cells. But these are precisely where Alata and Tengion are heading, pushing the industry into fresh territory. Coupled with new regenerative treatments like Cook biotech's foams and stem-cell organ patching, tissue engineering will be keeping our organs young and healthy in the years to come.

Merely a decade ago, tissue engineering was still a new field that struggled to find funding and support. Today, thousands of scientists worldwide are coordinating efforts to reach new breakthroughs, and the demonstrated potential of these methods has helped bring in investors. That should keep the organ growing field moving forward in the future months and years, and we'll be covering new advances as they emerge.

Check out this Wired Science video that tours around Atala's lab:

Drew Halley is a graduate student researcher in Anthropology and is part of the Social Science Matrix at UC Berkeley. He is a PhD candidate in biological anthropology at UC Berkeley studying the evolution of primate brain development. His undergraduate research looked at the genetics of neurotransmission, human sexuality, and flotation tank sensory deprivation at Penn State University. He als...

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Why transplant an organ when you can grow yourself a new one? This research isn't something that might happen in the distant future. It's being used today to grow fresh organs, open up new ways to study disease and the immune system, and reduce the need for organ transplants.

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A doctor grabs cells from the patient that is in need of a body part. Over 7 home grown bladders have been used and placed in transplants and have not been rejected. Muscle and bladder cells are grabbed from the patient and grown in a mold. When they are put in a right environment they are growing at a rapid rate. soon they will move to 3D printed organs due to the fact they are the new form of creating organs that are vital to humans.

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Antibacterial Envelope to Prevent Cardiac Implantable Device Infection

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Antibacterial Envelope to Prevent Cardiac Implantable Device Infection

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https://www.nejm.org/doi/full/10.1056/NEJMoa1901111

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This biomedical innovation is an absorbable, antibiotic-eluting envelope that was develop to reduce the incidence of infection associated with CIED implantations. The article illustrates the reason to why this medical innovation came about to be as well as the test nd research that was done in order to asses that it's safety and efficiency in preforming its purpose. The article describes various topic that collate with the need as well as the development of this innovation. The article provide details about the trials it went through, the methods used to conduct the trials as well as the results and conclusion of the trial. The article also provides other relevant information.

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This biomedical innovation is an absorbable, antibiotic-eluting envelope that was develop to reduce the incidence of infection associated with CIED implantations. The article illustrates the reason to why this medical innovation came about to be as well as the test nd research that was done in order to asses that it's safety and efficiency in preforming its purpose. The article describes various topic that collate with the need as well as the development of this innovation. The article provide details about the trials it went through, the methods used to conduct the trials as well as the results and conclusion of the trial. The article also provides other relevant information.

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This article discusses how spinal cord stimulation is a game-changing technology that has the ability to help patients control their pain. For patients with severe regional pain syndromes, failed back surgery syndrome, and other neuropathic pain syndromes, SCS has been used to to alleviate pain, increase functional capacity, and boost the quality of life over all. According to some studies done electrophysiological experiments on spinal cord neurons sparked the concept. The SCS system can interact with neurons in the spinal cords and change the stimulation accordingly. This system listens to the spinal cord's neuron, and it interacts with the living nerve system, which increases effectiveness.

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A treatment that focus on restoring joint function. This treatment can be temporary or curable for joint pain.

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A treatment that focus on restoring joint function. This treatment can be temporary or curable for joint pain.

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FDA approves new breakthrough therapy for cystic fibrosis

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FDA approves new breakthrough therapy for cystic fibrosis

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The U.S. Food and Drug Administration today approved Trikafta (elexacaftor/ivacaftor/tezacaftor), the first triple combination therapy available to treat patients with the most common cystic fibrosis mutation. Trikafta is approved for patients 12 years and older with cystic fibrosis who have at least one F508del mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene, which is estimated to represent 90% of the cystic fibrosis population.

"At the FDA, we're consistently looking for ways to help speed the development of new therapies for complex diseases, while maintaining our high standards of review. Today's landmark approval is a testament to these efforts, making a novel treatment available to most cystic fibrosis patients, including adolescents, who previously had no options and giving others in the cystic fibrosis community access to an additional effective therapy," said acting FDA Commissioner Ned Sharpless, M.D. "In the past few years, we have seen remarkable breakthroughs in therapies to treat cystic fibrosis and improve patients' quality of life, yet many subgroups of cystic fibrosis patients did not have approved treatment options. That's why we used all available programs, including Priority Review, Fast Track, Breakthrough Therapy, and orphan drug designation, to help advance today's approval in the most efficient manner possible, while also adhering to our high standards. The FDA remains committed to advancing novel treatment options for areas of unmet patient need, particularly for diseases affecting children."

Cystic fibrosis, a rare, progressive, life-threatening disease, results in the formation of thick mucus that builds up in the lungs, digestive tract, and other parts of the body. It leads to severe respiratory and digestive problems as well as other complications such as infections and diabetes. Cystic fibrosis is caused by a defective protein that results from mutations in the CFTR gene. While there are approximately 2,000 known mutations of the CFTR gene, the most common mutation is the F508del mutation.

Trikafta is a combination of three drugs that target the defective CFTR protein. It helps the protein made by the CFTR gene mutation function more effectively. Currently available therapies that target the defective protein are treatment options for some patients with cystic fibrosis, but many patients have mutations that are ineligible for treatment. Trikafta is the first approved treatment that is effective for cystic fibrosis patients 12 years and older with at least one F508del mutation, which affects 90% of the population with cystic fibrosis or roughly 27,000 people in the United States.

The efficacy of Trikafta in patients with cystic fibrosis aged 12 years and older was demonstrated in two trials. The first trial was a 24-week, randomized, double-blind, placebo-controlled trial in 403 patients who had an F508del mutation and a mutation on the second allele that results in either no CFTR protein or a CFTR protein that is not responsive to ivacaftor or tezacaftor/ivacaftor alone. The second trial was a four-week, randomized, double-blind, active-controlled trial in 107 patients who had two identical F508del mutations.

In each trial, the primary analysis looked at increases in the percent predicted forced expiratory volume in one second, known as ppFEV1, which is an established marker of cystic fibrosis lung disease progression. Trikafta increased the ppFEV1 in both trials. In the first trial, it increased mean ppFEV1 13.8% from baseline compared to placebo. In the second trial, it increased mean ppFEV1 10% from baseline compared to tezacaftor/ivacaftor. In the first trial, treatment with Trikafta also resulted in improvements in sweat chloride, number of pulmonary exacerbations (worsening respiratory symptoms and lung function), and body mass index (weight-to-height ratio) compared to placebo.

The safety profile of Trikafta is based on data from the 510 cystic fibrosis patients in the two trials. The safety profile was generally similar across all subgroups of patients. Serious adverse drug reactions that occurred more frequently in patients receiving Trikafta compared to placebo were rash and influenza (flu) events. The most common adverse drug reactions included headaches, upper respiratory tract infections, abdominal pains, diarrhea, rashes, increased liver enzymes (alanine aminotransferase and aspartate aminotransferase), nasal congestion, increased blood creatine phosphokinase (an enzyme that can be associated with muscle damage), rhinorrhea (mucus in the nasal cavity), rhinitis (swelling of the mucous membrane of the nose), influenza, sinusitis and increased blood bilirubin (may be caused by problems involving the liver, gallbladder or red blood cells).

The prescribing information for Trikafta includes warnings related to elevated liver function tests (transaminases and bilirubin), use at the same time with other products that are inducers or inhibitors of another liver enzyme called Cytochrome P450 3A4 (CYP3A), and the risk of cataracts. Patients and their caregivers should speak with a health care professional about these risks and any medicines they take before starting treatment.

Patients with cystic fibrosis should speak with a health care professional and have tests performed to understand which gene mutations they have. The presence of at least one F508del mutation should be confirmed using an FDA-cleared genotyping assay prior to treatment. The safety and effectiveness of Trikafta in patients with cystic fibrosis younger than 12 years of age have not been established.

The FDA granted this application Priority Review, in addition to Fast Track and Breakthrough Therapy Designation. Trikafta also received orphan drug designation, which provides incentives to assist and encourage the development of drugs for rare diseases. Drugs approved under expedited programs are held to the same approval standards as other FDA approvals. Because of Trikafta's benefit to the cystic fibrosis community, the FDA reviewed and approved Trikafta in approximately three months, ahead of the March 19, 2020 review goal date. The approval of Trikafta was granted to Vertex Pharmaceuticals Incorporated, which will receive a Rare Pediatric Disease Priority Review Voucher for developing this therapy.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation's food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

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FDA approves new breakthrough therapy for cystic fibrosis

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The U.S. Food and Drug Administration today approved Trikafta (elexacaftor/ivacaftor/tezacaftor), the first triple combination therapy available to treat patients with the most common cystic fibrosis mutation. Trikafta is approved for patients 12 years and older with cystic fibrosis who have at least one F508del mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene, which is estimated to represent 90% of the cystic fibrosis population.

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This article talks about a new drug that targets a gene sequence in the DNA of over 90% of cystic fibrosis patients. Cystic fibrosis is a life threatening disease where mucus can build up in the lungs and restict breathing. It is caused by a gene mution on the CFTR gene.

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"UCSF offers the full range of minimally invasive approaches for mitral valve repair and replacement using a small 4-6 cm incision. The benefits are significant including less post-operative pain at the incision site, a shorter hospital stay, a faster return to normal activities, and an improved cosmetic result."

Tobias Deuse, M.D., Director, Minimally-invasive Cardiac Surgery

The mitral valve consists of two leaflets, supported by chordae and papillary muscles, and located between the left atrium and left ventricle of the heart. The mitral valve prevents blood from leaking back into the lungs when the heart contracts. When the valve fails, patients may be severely affected.

Degenerative mitral valve disease is a common disorder affecting around 2% of the population. Common findings include a "prolapse" ( slipping or falling our of place), due to elongation or rupture of the chordal apparatus. When the two leaflets fail to close tightly, the mitral valve becomes insufficient, sometimes allowing blood to leak back into the atrium from the ventricle.

A prolapse can occur on either the anterior (front) leaflet or the posterior (rear) leaflet. Usually, the annulus, where the leaflets attach, is also dilated or enlarged.

Mitral Valve Prolapse on Anterior Leaflet Mitral Valve Prolapse on Posterior Leaflet

Why is Mitral Valve Insufficiency Dangerous?

Patients may become symptomatic, experiencing shortness of breath, reduced stamina, fatigue during exercise (exercise intolerance), and arrhythmia (i rregular heartbeat ). Moreover, severe mitral insufficiency reduces life expectancy, even in patients who are asymptomatic.

When Should Mitral Valve Insufficiency Be Treated?

Large studies have demonstrated that severe mitral valve insufficiency should be repaired early on before irreversible structural changes in the heart occur, a treatment strategy also recommended by both the American Heart Association and European Society of Cardiology. Unless treated before the heart structurally remodels, patients will experience reduced life expectancy (as compared with healthy patients without evidence of heart disease).

Can Surgery Be Performed Using Keyhole Incisions?

Patients with isolated mitral valve disease may be candidates for minimally invasive surgery, so long as they do not have clinically relevant aortic valve disease or coronary artery disease. Surgeons perform the operation by making only a small 4-6 cm incision on the right side of the chest instead of the large midline-incision and division of the sternum used traditional open surgery.

The surgery is performed through the small space between the ribs. The heart-lung machine is inserted via a small incision in the groin, allowing the heart to be stopped during repair of the valve. A soft retractor is inserted, which gently opens the narrow space between the ribs, enabling the surgeon to insert the specialized minimally invasive instruments. An endoscope, ideally with a 3D camera, is inserted that will provide a high-resolution image of the mitral valve.

Using this technique, the stability of the chest is fully preserved, patients recover more quickly, and the minimal scar will be barely visible after the patient recovers.

What are the Surgical Options?

The preferred surgical strategy for treatment of mitral valve disease is to repair the patient's own mitral valve (vs.replacing it). The advantages of repair include:

Prolonged durability of the repaired valve

Prolonged life expectancy

Avoidance of long-term anticoagulation

Better preservation of heart function

This is especially true when techniques are used to preserve the maximum amount of native mitral valve tissue, and where artificial chordae are used to correct the valve geometry. The results have proven to be long lasting and durable.

Only mitral valves showing extensive calcification or active bacterial infection may, under certain circumstances, need outright replacement .

What Happens During Surgery to Repair the Mitral Valve?

During the operation, the valve is thoroughly inspected and a strategy developed for performing the repair. In the example below, several chords to the anterior leaflet are ruptured as well as leaflet prolapse and annulus dilatation.

Chords to the Anterior Leaflet Ruptured with Leaflet Prolapse and Annulus Dilatation

Artificial chords made out of GoreTex, which function like natural chords, are inserted at the location of the ruptured chords,. The sutures are then passed through the papillary muscles and are extended to the free edge of the leaflet.

The suture length is then adjusted to conform to the geometry of the valve. Later, an annuloplasty ring is sized and implanted to support the repair, and maintain the optimized valve geometry.

What Are the Benefits of Minimally Invasive Mitral Valve Surgery?

Reduced pain, blood loss and risk of infection

Shorter hospital stay

Faster recovery and return to work

Less scarring and improved appearance after surgery

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"UCSF offers the full range of minimally invasive approaches for mitral valve repair and replacement using a small 4-6 cm incision. The benefits are significant including less post-operative pain at the incision site, a shorter hospital stay, a faster return to normal activities, and an improved cosmetic result."

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Severe mitral valve insufficiency is when the mitral valve prevents blood from leaking back into the lungs when the heart contracts, as such the valve fails and leads to further complications. However patients with isolated mitral valve disease may be candidates for minimally invasive surgery as long as they do not have relevant aortic valve disease. Surgeons perform the operation through the small space between the ribs, whereas they make a small 4-6cm incision on the right side of the chest instead of making a large incision in the middle of the chest. Through the use of this technique the stability of the best of fully preserved, recovery time is short, and there is less scarring

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Peanut immunotherapy that gives a patient a little of peanut for 6-12 months they can soon have a 70%-80% of a higher doses than before.

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Jacob Kingsley was 9 years old when he was handed the poison he'd shunned since before he could walk and told to swallow it as medicine. Obediently, he gulped down a few micrograms of peanut flour-less than 1/1000 of a peanut-diluted in grape Kool-Aid. His mother and a nurse hovered, ready to inject him with epinephrine if an itchy throat and wheezing struck.

Jacob's mother, Jennifer Kingsley, had driven him 2 hours from their home in Columbus to this doctor's office in Cincinnati, Ohio, for the first of dozens of sessions of peanut immunotherapy. Giving Jacob gradually increasing doses of peanuts, she hoped, would desensitize his immune system.

It's a strategy Kingsley hadn't pursued until she reached her breaking point. A year earlier, Jacob had swallowed a handful of popcorn that, unbeknownst to him, was laced with peanut product. He suffered a particularly frightening reaction: two bouts of intense symptoms about 6 hours apart. The incident marked his second peanut-related trip to the emergency room, and Kingsley was terrified that the next encounter could be fatal. "I decided, 'I can't live like this,'" she says. "I was desperate."

As Jacob sat through the hourslong appointment in Cincinnati, playing video games and swigging increasing doses of peanut-spiked Kool-Aid, he joined legions of children writing food allergy's next chapter. Today, more than 3000 people worldwide, most of them children, have undergone peanut immunotherapy, with the goal of protecting them if they accidentally encounter the food. Other children are trying immunotherapy for allergies to milk, eggs, and tree nuts. Some, like Jacob, get treatment in allergists' offices, where doctors share protocols informally and in published papers. Other children have enrolled in clinical trials, including those run by two companies racing to introduce a peanut-based capsule or skin patch. Both plan to apply for approval from the Food and Drug Administration (FDA) this year. The agency's blessing would dramatically boost immunotherapy's credibility and reach.

In a field that for decades has had nothing to offer patients beyond avoidance, immunotherapy marks a seismic shift. As it edges closer to mainstream, "There's mixed feelings, with a whole range of enthusiasm," says Corinne Keet, a pediatric allergist-immunologist at Johns Hopkins Medicine in Baltimore, Maryland. Fear that it might cause harm is mingling with euphoria that children living constrained lives could be set free. Doctors who offer immunotherapy describe families eating in Chinese restaurants for the first time and home-schooled children rejoining their peers.

Like many medical firsts, the therapy is not perfect. "This is version 1.0," says Brian Vickery, a pediatric allergist-immunologist at Emory University in Atlanta. He has conducted peanut immunotherapy trials and worked for 2 years at Aimmune Therapeutics, headquartered in Brisbane, California, one of the companies whose products are nearing approval. Physicians fret about oral immunotherapy's rigors-treatment must continue indefinitely-and its risks, which include the same allergic reactions it aims to prevent. Last year in Japan, a child suffered brain damage during a trial of immunotherapy for milk allergies.

Meanwhile, physicians on the front lines are navigating hazy science. No one knows exactly how immunotherapy works or who's most likely to be helped or hurt by it. "For me," Keet says, "it's really not clear for an average child with peanut allergy whether it will make sense to do oral immunotherapy or not."

Like many who study food allergies, Keet was enticed by their mystery. Animal models are poor. The intensity of allergic reactions varies unpredictably, even in the same person over time. Why one child outgrows an allergy and another doesn't is unknown.

"This was something we didn't cover much in medical school" in the 1990s, says Matthew Greenhawt, a pediatric allergist-immunologist at Children's Hospital Colorado in Denver. Greenhawt's career trajectory tracks with a surge in food allergies, and these days, he can barely keep up with the stream of affected children who visit his hospital. Today, between 1% and 2% of people in the United States, the United Kingdom, and several other countries are allergic to peanuts-a rate that has roughly tripled since the mid-1990s. Other food allergies, such as those to tree nuts, are also on the rise. What's causing the increase is not well understood.

Despite rising caseloads, deaths from food allergies remain rare. Precise numbers are hard to come by, and estimates range from fewer than 10 to more than 150 a year in the United States. But even though an affected child is more likely to be struck by lightning than to die of a food allergy, the risk can feel ever-present. Parents never know when their children will happen upon culprit foods and how they'll be affected if they do. "We live in a complex world-people move food all over the place," says David Bunning, a businessman whose two sons, now adults, have multiple food allergies. "The impact on children in terms of their confidence to explore their environment can be extreme." Bunning's family almost never traveled or ate out. At their grandparents' house, the boys were usually confined to one room where food wasn't allowed.

Bunning now chairs the board of directors at Food Allergy Research & Education (FARE), an advocacy group in McLean, Virginia. Families like his, and the doctors who cared for their children, began to agitate for new treatments about a decade ago. Immunotherapy was the obvious candidate: Injections that desensitize the immune system to pollen, grass, pet dander, and bee venom have been around for decades.

Whether for an allergy to cats or pistachios, immunotherapy aims to disrupt the cells that swing out of control when faced with an allergen. When a child who is allergic to a food eats it, food proteins cross from the digestive tract into the bloodstream. An antibody called immunoglobulin E (IgE), which is bound to white blood cells called mast cells in tissues, recognizes the culprits. IgE activates the mast cells, which release histamine and other chemicals. In the skin, that response can lead to hives; in the respiratory tract, wheezing; and in the gut, vomiting. The most serious symptoms, such as a swollen throat or a reaction throughout the body, mark anaphylaxis, which is what families fear the most. Allergy shots blunt production of IgE, in part, researchers believe, by boosting levels of certain T cells that prompt a cascade of immune changes.

Peanuts Fighting fire with fire Eating gradually increasing doses of a food allergen seems to desensitize the immune system over time. Thousands of children have tried oral immunotherapy, and a capsule to treat peanut allergies might be approved by regulators next year. But there's anxiety about the strategy's risks and unknowns. When a child eats a food they're allergic to, an antibody called immunoglobulin E (IgE) helps touch off events that lead to symp-toms from mild to severe. Symptoms can hit the skin, as shown, and also the gut, the respiratory system, and beyond. The level of IgE in the blood can drop. Less reactive mast cell Milder reactions on the skin and beyond. What's an allergic reaction? How does treatment work? Reactions include hives, itchy throat, vomiting, and difficulty breathing. Allergy symptoms Hives Wheezing Vomiting IgE, which binds to mast cells, alerts these white blood cells. They release histamine and other chemicals. Mast cells IgG4 IgA Children with food allergies have high levels of an antibody, IgE, that recognizes specific allergens. IgE Mast cell membrane Allergen IgE

Brief testing decades ago indicated that shots for food allergies weren't safe. So around the mid-2000s, scientists began to feed children the allergen instead. One watershed moment came in 2005, when the National Institutes of Health formed a consortium for food allergy clinical trials. A second was in 2011, when advocates sponsored a symposium at Harvard Medical School in Boston to standardize goals and strategy for the pioneering immunotherapy efforts. About 60 people attended. "The patients were very clear," says Carla McGuire Davis, a pediatric allergist-immunologist at Texas Children's Hospital in Houston. They didn't care about eating a peanut butter sandwich; they wanted protection if they accidentally encountered one. Trialists set their end dose at a couple of peanuts and pressed ahead.

The results of early clinical trials were promising, says Hugh Sampson, a pediatric allergist-immunologist at the Icahn School of Medicine at Mount Sinai in New York City, who has studied immunotherapy in food allergies for many years. After 6 to 12 months of treatment, he says, about 70% to 80% of patients could handle higher doses of the food than before. Lab data were encouraging, too: Ingesting allergens over time seems to make mast cells less reactive, inhibiting their release of harmful chemicals. The therapy also produces other immunoglobulins: IgG4, which further inhibits mast cell activity, and IgA, which helps keep food allergens from escaping the gut.

The 2011 conference inspired the founding of the company now called Aimmune, fueled by more than $3.5 million from FARE. A second company, DBV Technologies, based in Montrouge, France, and New York City, expanded a few years later. Aimmune began to develop an oral product, essentially a capsule of powder derived from peanut flour with proteins held to consistent levels. In February, the company announced in a press release the results of a phase III trial involving 496 children and teenagers, with a regimen stepping up every 2 weeks through 11 dose levels. Among the 372 people in the treatment group, about 20% dropped out for various reasons, including side effects. After about a year, 96% of people who completed treatment could consume one peanut with no more than mild symptoms, 84% could tolerate two, and 63% could tolerate at least three.

DBV's skin patch represents a more conservative strategy: It delivers tiny amounts of peanut protein, the equivalent of one peanut over 3 years. Last year, DBV announced that in its phase III trial of almost 400 patients, after a year, those using the patch could, on average, eat three peanuts over the course of several hours before experiencing clinical symptoms such as vomiting or hives; before the trial, the average was just under one peanut. Outcomes varied substantially from person to person.

If one or both products are approved by FDA in the coming months, expectations are high that they'll be welcomed: Aimmune is now worth about $1.5 billion on the U.S. stock exchange. In 2016, FARE sold its share in Aimmune for $47 million.

What people don't understand is this level of protection fluctuates. ... It is not guaranteed, nor is it constant.

Mimi Tang, Murdoch Children's Research Institute

Meanwhile, some doctors embrace another route: offering peanut immunotherapy in their practices. "I can treat 20 patients with $5.95 of peanut flour," says Richard L. Wasserman, a pediatric allergist-immunologist in Dallas, Texas.

Wasserman ventured into food allergy immunotherapy 11 years ago. He developed a protocol based partly on published case reports and protocols for allergy shots, and he put IVs into his first five peanut allergy patients in case he had only seconds to rescue them from severe anaphylaxis. "When they all sailed through the first day, we stopped doing IVs," he says. "But that's a measure of how concerned I was."

Wasserman has since treated more than 300 children with peanut allergies and more than 400 with other food allergies. Other practitioners are joining in, among them the Cincinnati allergist whom the Kingsley family sought out: Justin Greiwe at Bernstein Allergy Group. Greiwe joined the practice in 2014, straight out of medical training. "It was a little nerve-wracking at the beginning," he says, because no officially sanctioned oral immunotherapy protocol existed. He took precautionary measures, such as lung testing before every treatment, to help ensure patient safety.

Some clinicians-and executives at the companies developing products-aren't happy about the doctor's office treatments. "That gives a lot of us pause," says Sampson, who in addition to his academic post is chief scientific officer of DBV. "We're very afraid that if this goes on enough, somebody is going to have an accident or a fatal reaction, and that's really going to change the FDA's viewpoint" about the products in development, he says.

Wasserman agrees about the need for caution. "Not every practicing allergist should be doing oral immunotherapy," he says. Greiwe suggests the treatment requires a dedicated staff, and he gives every immunotherapy family his cellphone number.

Jacob was one of Greiwe's first immunotherapy patients. His mother remembers Jacob's ears burning-a minor reaction that subsided on its own. "Or he said he hated peanuts and wanted to quit," she says. Worst was about 6 months in, when Kingsley discovered that for 2 weeks, Jacob had hidden his dose to avoid eating it. That was "the only time we ever felt danger," she says. Stopping treatment can quickly alter the immune system, says Cecilia Berin, an immunologist at Mount Sinai, because immunotherapy requires constant exposure. When Jacob squirreled away his daily dose, the changes induced in his immune system almost certainly started to fade out, putting him at risk. Greiwe restarted him on a lower dose and, his mother says, "We got through it."

Even children who faithfully follow instructions face risks. The immune system can react to even subtle pressures, and the list of what can provoke a reaction to treatment is long. Exercising within a couple of hours of the dose can do it; so can a cold, a stomach virus, menstruation, or a hot shower. An asthma attack can trigger a reaction-many children with allergies have asthma as well-and so can stress. "We had a patient who had just played the violin on a stage, came down, and about 15 minutes later ... took the dose and had a reaction," Davis says.

Berin posits that external pressures such as physical activity or illness make the gut more permeable, pushing more of the immunotherapy dose into the bloodstream. But that remains hypothesis. Regardless, it's becoming clear that "there are people who react years down the road to a maintenance dose," Keet says. For Jacob, such a moment came 9 months in. One evening while watching a movie, he downed his peanut M&M's and later ran outside with his cousins to dance in a rainstorm. He broke out in hives head to toe. Kingsley dialed Greiwe's number, and Jacob got a double dose of an allergy medication.

The most tragic data point to date is the case in Japan. A child had enrolled in a trial of immunotherapy for milk allergies at the Kanagawa Children's Medical Center in Yokohama. He'd raised what he could ingest from less than 8 milliliters to 135 milliliters-about half a glass of milk. After 3 months on that maintenance dose, he swallowed it and soon complained of pain. Within minutes, he had stopped breathing. His heartbeat was later restored in the emergency room, but he'd gone too long without it and sustained severe brain damage, according to a statement from the hospital's president, Sumimasa Yamashita, in November 2017. Kanagawa Children's Medical Center declined to comment, saying only that the incident remains under investigation.

In its statement, the hospital noted the boy had suffered an asthma attack the day before the catastrophic dose. He also was on a protocol that aimed to rapidly escalate the volume of milk he could drink over less than 3 weeks. But why the child reacted so disastrously to that glass of milk is unknown.

"What people don't understand is this level of protection fluctuates," says Mimi Tang, a pediatric allergist-immunologist at Murdoch Children's Research Institute in Melbourne, Australia. "It is not guaranteed, nor is it constant."

One of the few long-term analyses was published in 2013 in The Journal of Allergy and Clinical Immunology. Keet, pediatric allergist-immunologist Robert Wood at Johns Hopkins Medicine, and their colleagues sought out 32 children who'd been in a milk immunotherapy trial. Three to 5 years later, "The results were surprising in a sobering kind of way," Wood says. Only about a quarter "were doing great ... tolerating unlimited quantities of milk without side effects." Another quarter had abandoned the protocol and returned to strict avoidance. The rest were eating dairy products inconsistently, with intermittent or even frequent allergic reactions. "It's hard to know which comes first, whether they got complacent" about ingesting it "or backed off because [they were] having too many symptoms," Wood says.

It made me nervous, really nervous, to put something in my daughter's mouth that she was allergic to.

Divya Balachandar, mother of Leena Wong

More and more families are willing to live with those uncertainties because the alternative is greater anxiety. "We were scared senseless," says Divya Balachandar, whose daughter Leena Wong, now 7 years old, had her first episode of anaphylaxis at age 4 after being touched by a cashew. Testing revealed Leena also was allergic to sesame, eggs, milk, other tree nuts, and peanuts. Balachandar, a pediatric pulmonologist in New York City, and her husband enrolled Leena in a federally funded oral immunotherapy trial for peanut allergy in 2015. "It made me nervous, really nervous, to put something in my daughter's mouth that she was allergic to," Balachandar says. She gravitated toward a trial over treatment with a local allergist because, she says, "there were no rules" about how to treat in private practice. By this spring, Leena could eat two spoonfuls of peanut butter-about 25 peanuts-without a problem. She started second grade sitting with her classmates at lunchtime, liberated from a separate nut-free table.

Both companies developing peanut-based treatments say they had more volunteers for their trials than they could accommodate. Private practitioners usually have a waiting list; Greiwe's runs more than 4 months. At Stanford University in Palo Alto, California, which has a large food allergy research program, more than 2000 patients are waitlisted to enroll in the university's clinical trials, says Sharon Chinthrajah, an allergist-immunologist there.

More treatments are on the horizon. In Australia, Tang is working with a company that's testing an approach she pioneered, a combination of a probiotic and oral peanut immunotherapy. The probiotic should tilt the body toward producing the subset of T cells that tolerate the allergen and away from making cells that attack it, she says. Chinthrajah and others are enthusiastic about combining oral immunotherapy with a monoclonal antibody called omalizumab, which is FDA approved to treat allergic asthma. Clinical trials are also gearing up to test other monoclonal antibodies that target molecules involved in allergic inflammation.

Jacob's and Leena's families are eager to see what comes next. Jacob is also allergic to pistachios and cashews, but because he finds those foods easier to avoid than peanuts, the family has rejected immunotherapy that targets them. Leena's family is the opposite. With her older sister and her parents, Leena attends Indian functions regularly, where tree nuts are a common ingredient in sauces. In August, another episode of anaphylaxis landed her in the emergency room: She began to vomit and suffered chest tightness and eye swelling after eating Indian food her parents suspect contained cashews-despite having triple-checked with the restaurant that it did not. "I would love to do tree nuts," Balachandar says, once immunotherapy "becomes more available and better understood."

Physicians with deep roots in food allergy immunotherapy hope those new to it tread carefully. Doctors who offer such treatments "have to know the data cold," including published results and side effects that may crop up, Greenhawt says. Still, he's thrilled that peanut immunotherapy treatments may soon be approved. The other day, talking with a peanut-allergic 4-year-old and his mother, Greenhawt shared what the next year might bring. "I said, 'I'm going to see you a year from now; hopefully, we will have two products that are approved, and we can talk about which one might be best for you.'" The mother looked startled and delighted, Greenhawt says. "I've never seen somebody smile as brightly as that."

doi:10.1126/science.aav7498

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