Category: Uncategorized

Invasive Fungal Sinusitis

Invasive fungal sinusitis can have a serious affect on you if you are an immunocompromised individual; however, immunocompetent patients are still susceptible to this condition. There two different forms of invasive fungal sinusitis varying in severity: acute invasive fungal sinusitis, and chronic invasive sinusitis. While acute invasive fungal sinusitis is the most serious and severe condition, it is important to discuss the both forms as all their associated problems still manifest themselves in harmful ways.

It is important to discuss the definition of immunodeficiency, as it is a condition that fosters invasive Fungal Sinusitis. A person who exhibits immunodeficiency is said to be immunocompromised. Being immunocompromised means your immune system is damaged and/or inhibited making it extremely difficult for your body to fight off infections and disease. This is especially concerning for patients infected with pathogenic fungus, like in invasive fungal sinusitis, as it is hard to rid the body of the infection.

Primarily exhibiting itself in immunocompromised patients, acute invasive fungal sinusitis is the most aggressive form of invasive fungal sinusitis with high mortality rates. The most common fungus found with invasive fungal sinusitis is Aspergillus. According to Dr. Bruno Di Muzio et al of Hospital Santa Paula in São Paulo, people with diabetes mellitus and patients with nervous system conditions like haematologic malignancies are prone to this form of invasive fungal sinusitis.1 Additionally, patients with advanced AIDS are susceptible to invasive fungal sinusitis. Infection begins in the nasal cavity and spreads to the paranasal sinuses. Symptoms can include a thickening of mucous consistency, bone destruction, and fat stranding outside the sinuses.2 Currently, the most effective treatment of acute invasive fungal sinusitis is early detection and diagnosis and subsequent surgical and medical treatment repair or bolster a compromised immune system. However, once the fungus infection establishes itself in the sinus, it is very hard to remove the fungus and cure the disease. Unfortunately, mortality rates in acute invasive fungal sinusitis are high.

Chronic invasive fugal sinusitis is a less severe form of invasive sinusitis and typically has a longer course of action. This variant of invasive sinusitis is found present in mostly immunocompetent individuals or individuals that are only mildly immunocompromised. This condition typically takes more than 12 weeks to manifest itself in a patient’s body. Its symptoms are similar but less severe than acute invasive fungal sinusitis.

Invasive fungal sinusitis is a serious problem for immunocompromised patients and is very damaging to the nervous system and the patient’s health. Its mortality rates are high and current treatment methods are vague and generally ineffective. This condition should be researched and understood, and solutions be explored and implemented.

1Muzio, Bruno, Dr., and Frank Gaillard, A.Prof. “Chronic Invasive Fungal Sinusitis | Radiology Reference Article | Radiopaedia.org.” Radiopaedia Blog RSS. Accessed June 13, 2016. http://radiopaedia.org/articles/chronic-invasive-fungal-sinusitis.

2 Deshazo, Richard D. “Syndromes of Invasive Fungal Sinusitis.” Medical Mycology 47, no. 1 (May 19, 2008). Accessed June 13, 2016. http://mmy.oxfordjournals.org/content/47/Supplement_1/S309.full.

Chronic Rhinosinusitis (CRS)

Chronic Rhinosinusitis or “CRS” is defined as sinus inflammation involving the nasal mucosa and paranasal sinuses with 2 or more symptoms persisting for 12 weeksor longer with incomplete resolution of symptoms.[i]

Refractory chronic rhinosinusitis (“RCRS”) is a term used to describe CRS that is unresponsive or refractory to medical and surgical therapy.[ii]

Fungal rhinosinusitis encompasses a wide variety of fungal infections that range from merely irritating to rapidly fatal.  Invasive fungal Rhinosinusitis (“IFS”) is classified as either acute or chronic, is difficult to treat and is a significant cause of morbidity and mortality in immunocompromised patients.

 

Figure 1: Outline of the complex cycle in the development of CRS.
 Factors that may contribute to the development of CRS include exposure to allergens and irritants, defects in mucociliary function, immunodeficiency and infections with bacteria, viruses and fungi.  The common endpoint is local inflammation and swelling of the sinonasal mucosa and impairment of normal sinus drainage.  The recognition that CRS represents a multifactorial inflammatory disorder, rather than simply a persistent bacterial infection, has led to the re-examination of the role of antimicrobials in CRS.

The medical management of CRS is now focused upon controlling the inflammation that predisposes patients to obstruction, thus minimizing the incidence of infections.  Despite this, all forms of CRS are associated with poor sinus drainage and secondary bacterial infections.  Most patients require antibiotics to clear infections at the outset of therapy and intermittently thereafter to treat acute exacerbations of CRS.  However, the role of these agents beyond these two indications remains an area of investigation.[i]


[i]  Rosenfeld Richard M et al; Clinical practice guideline: Adult sinusitis Otolaryngology-Head and Neck Surgery (2007) 137, S1-S31

[ii]  Desrosiers M., Refractory chronic rhinosinusitis: pathophysiology and management of chronic rhinosinusitis persisting after endoscopic sinus surgery. Cur Allergy Asthma Rep. 2004 May; 4(3):200-7

Immediate Harm

We’re beginning to understand the harm caused by our antibiotic 'bombs'.

According to a leading medical journal, viral infection is the cause of up to 98% of sinusitis and, in the USA, the disorder affects about 14% of the adult population every year, i.e. some 30 million Americans. Despite the likely viral cause, antibiotics are prescribed “more often than not;” indeed, sinusitis is the fifth leading reason for prescription of antibiotics by US primary care physicians.

What drives this massive over-prescription problem is a mindset among physicians that “antibiotics won’t do any harm and may help,” says highly-regarded infectious disease specialist Brad Spellberg, MD. He frames the issue this way:

“Perhaps if providers had a better grasp of the risk for immediate harm caused to the patient by the antibiotic prescription — as opposed to the vague and intangible notion of a small harm to society at large that may occur over time — they might be better armed to make a more appropriate risk/benefit decision about whether to prescribe the antibiotic … Resistance is not merely for the public at large. Resistance will occur in the individual patient as a consequence of their new prescription.” (My emphasis.)

The concern is not simply that antibiotics cause unwanted side effects like diarrhea, rashes, nausea, and stomach pain, and even life-threatening allergic reactions, kidney toxicity, and severe skin reactions, as the US Centers for Disease Control warns us. The story runs deeper than that. We think antibiotics are like laser-guided missiles that attack only the bugs that make us sick. But they’re not. They’re actually too powerful – like nuclear weapons that destroy everything, good bacteria included, said Margaret Riley, PhD, in her address to the Institute of Medicine this year.

We need our good bacteria – which is most of our bacteria – to keep us healthy. They help us digest food, build nutrients, and crucially, they’re part of our immune response. So if you knock them out with an antibiotic you are left more vulnerable to infection, immediately and in the long run.

The leading edge of antibiotic research is telling us things we couldn’t have imagined even a few years ago: for example, that the antibiotic-driven destruction of our microbiome – our internal collection of microbes, bacteria especially – is contributing to the rise of our “modern plagues:” obesity (antibiotics are The Fat Drug), asthma, allergies, diabetes, and certain forms of cancer.

But here’s the thing. These negative consequences happen even when you should use an antibiotic. Understandably, you have to risk it when dealing with a serious bacterial-driven infection which can be limb and life-threatening. But to prescribe antibiotics “more often than not,” when only 2% of sinusitis cases are bacterial is something our best clinician-researchers are telling us we need to stop – now.

 

 

 

Antibiotics: Cure or Curse?

Antibiotics: just say no!

First some background. Sinusitis is a huge problem that typically goes unnoticed. Over 30 million Americans are affected by sinusitis annually. In addition to the daily pain and suffering of those afflicted, additional  costs to society include 73 million days of restricted activity or lost work per year, and an estimated yearly financial burden of $5.8 billion.

Moreover, the vast majority of doctors themselves tell us they are dissatisfied with their ability to treat the disease. In a 2007 study published in The Journal of Allergy and Clinical Immunology, 202 doctors were surveyed from the US, UK, France, and Germany and  86% of them said they were generally unhappy with current treatment methods.

So here’s our issue – recent research gives us new insight into a major reason for our inability to treat sinusitis: the ill-advised use of antibiotics to treat a disease that’s typically viral-based.

Bacteria causes sinusitis in only 2% to 10% of cases, yet a national survey showed that 81% of adults presenting with acute sinusitis were prescribed antibiotics.

That’s like using a fishing rod to hunt deer, as bacteria and viruses are entirely different “animals.”

In fact antibiotics are so over-prescribed that sinusitis is now the fifth leading indication for antimicrobial prescriptions by primary care physicians.

The reason for wrongly prescribing antibiotics is that distinguishing between  bacterial and viral-bases sinusitis is difficult to do. Normally, the difference can’t be differentiated in the first 10 days of the onset of the illness.

So in 2012 the Infectious Disease Society of America issued guidelines to help doctors and their patients distinguish between the two.  Generally speaking the longer the symptoms last and the more severe they are the more likely it is that the problem is bacterial-based. IDSA defines severe symptoms as those that last for ≥10 days without improvement, high fever, i.e. ≥ 39°C  or  102°F, or a pussy nasal discharge or facial pain lasting for at least 3 to 4 consecutive days. 

Here’s one more thing to consider. What happens when you take an antibiotic when you shouldn’t? To begin with it won’t help you with your illness – you might as well have taken a sugar pill. But something else happens too: it kills off your “good” bacteria and what’s left over is the “bad” bacteria – those that are resistant to antibiotics (that’s why they’re still there). The resistant bacteria then go on to “multiply” taking over the space formerly occupied by the “good” bacteria.

So here’s the rub: say you eventually contract a bacterial-based ailment like pneumonia for which you require antibiotics – what happens when you take them? Nothing, the pneumonia will continue unchecked. And that’s because your bacteria are now resistant to antibiotics – remember, that’s what’s left after taking that first ill-advised batch of antibiotics. And that can put you in a very difficult spot when  you can’t treat something serious like a pneumonia – it can eventually heal on its own – or not.

The lesson? Before you ask for antibiotics or before your doctor decides prescribes them for you – for sinusitis or otherwise – be sure to ask this question: Doctor, how do you know my illness is caused by bacteria and not by a virus or some other pathogen?

The answer can be the difference between restored health and continued suffering – or between life and death.

 

 

 

 

 

 

 

 

 

 

Sinuwave Photodisinfection: Making a Difference for Refractory Chronic Sinusitis Patients

Carolyn Cross (CEO) with Sinuwave patient

Christina is from Winnipeg, Manitoba. She has been suffering for about ten years from recurring Chronic Rhinosinusitis (CRS). Over time, Christina found that she has become unresponsive to the medical and surgical treatments currently available. She is dealing with tenacious biofilms in her sinuses that have become resistant to antibiotics. She has had 5 or 6 surgeries and countless trips to an array of specialists. Christina lives with debilitating pain from recurring sinus infections and the ongoing concern about her future. Affecting her head and her breathing, this painful condition is hugely disruptive to everyday living. She is frustrated also, that by affecting her, CRS also impacts her entire family.

Otherwise a very healthy person, Christina worries that one day her medical options will run out. New technologies, like Sinuwave™ Photodisinfection, are important to people like Christina as they offer hope for a better quality of life. Christina is one of about 50,000 Canadians suffering from recurring refractory Chronic Rhinosinusitis. In the US, the refractory CRS population exceeds 500,000 and is growing by about 10% (50,000) each year.

Christina came to Vancouver from Winnipeg seeking help with her uncontrollable sinus infections. I had the privilege of spending time this week getting to know Christina and got a better understanding of the nature of the suffering that she gallantly endures. Seen here with me having her second Sinuwave treatment, I was thrilled to learn that her initial Sinuwave treatment the day before had already yielded some positive results for her.  It has taken us about 14 years to develop our innovative non-antibiotic antimicrobial technology to the point where it is now helping refractory CRS patients like Christina. I would like to take this time to thank each member of my very talented team for their personal efforts, sacrifices and dedication that contributed to an important new CRS treatment to help people like Christina.

— Carolyn Cross, CEO

Sinuwave Introduced to ENT Community at the American Rhinologic Society Conference

Clinicians attending the 59th Annual Meeting of the American Rhinologic Society Conference held on September 28th, 2013 in Vancouver were introduced to the Sinuwave™ Photodisinfection System. Sinuwave is the first Photodisinfection based therapy for the sinusitis market.  An abstract, entitled “Sinuwave Photodisinfection for the treatment of refractory chronic rhinosinusitis: a case series”, was submitted by researchers from the University of Montreal (Centre de Recherche du Centre Hospitalier de l’Université de Montréal (CRCHUM), Montreal, Canada) and presented at the Conference.

Sinuwave Photodisinfection System is Health Canada approved and was developed by Ondine Biomedical Inc. of Vancouver, the global leader in Photodisinfection, also known as antimicrobial Photodynamic Therapy (aPDT). Photodisinfection is a topical, non-antibiotic antimicrobial therapy that destroys a broad range of pathogens and their virulence factors, leading to a clinically observable anti-inflammatory effect.  Photodisinfection is a minimally invasive non-thermal therapy involving the light activation of a photosensitizer to eliminate topical infections in a highly targeted approach. Photodisinfection has been proven to be safe and effective in other applications such as for the dental and hospital acquired infection prevention markets. For more information about Sinuwave Photodisinfection, please visit www.sinuwave.com

What Would Galileo Say?

If we could be sure of anything in the early 17th century, when Shakespeare climbed onto the world stage, it was that the Earth stood still, and that the Sun and all the rest of the universe revolved around Us: We were at the center of everything – We were the Lords of the Universe. We knew this because Aristotle said so as far back as the 4th century BC. Scientists thereafter agreed and, if that wasn’t enough, it was also set down in Holy Scripture as interpreted by the Catholic Church, notably Pope Urban Vlll.

And then along came Galileo Galilei, later recognized as the father of experimental physics, who proposed something radical: that it was the Sun, not the Earth, that was the center of the universe – that we Earthlings and everything else in the universe revolved around It. The trick to Galileo’s discovery was technology – he had just invented the telescope, and with it the ability to track planetary movement.

Technology is indeed powerful.  It brought us the industrial revolution, it took us to the moon, and in the past 10 years it has allowed us to sequence our genomes. And there is yet one more thing it seems willing to do for us: treat one of the most common medical conditions in the United States that affects an estimated 37 million Americans – chronic sinusitis (CRS).

It’s considered chronic because it will last half a year or more, your head will be swollen & painful especially around you sinuses, you will miss a lot of work, and you will probably have to keep going back to the doctor for repeated treatment. People who have it report worse quality-of-life scores than those suffering from chronic obstructive pulmonary disease, congestive heart failure, back pain, or angina. It is stubbornly resistant to cure despite rigorous treatment regimens including surgery, allergy therapy, and prolonged antibiotic therapy.

In a significant sub-population of patients the reason for this treatment failure is thought to be related to the destruction of the sinus area defenses by the chronic sinus infection, resulting in the development of secondary antibiotic resistant microbial colonization of the sinuses – an infection upon an infection.

However, there is hope. Physician-scientist Merill Biel, MD, PhD, who received funding from the National Institutes of Health and published his investigations in the International Forum of Allergy and Rhinology, led a research team in 2011 and again this year to see if they could eliminate microbial pathogens responsible for chronic CRS. The trick, again, was in the technology – they used a procedure called photodynamic therapy (PDT).

The use of PDT is extensively reported in the literature to be safe and effective for the photodestruction of various microorganisms. It is a 2-step process. You apply a chemical compound to the affected area, and then target a beam of light on that compound. The result is that you destroy those microorganisms – bacteria, virus, or fungi – that have absorbed the compound. Recently, PDT has been more comprehensively studied as a potential alternative to conventional antibiotic therapy as antibiotic resistant strains of bacteria become more prevalent, notably methicillin-resistant staphylococcus aureus (MRSA).

The objective of the Biel study was to demonstrate the effectiveness of a non-invasive PDT treatment method of eradicating antibiotic resistant microorganisms known to cause CRS. What they found was extremely encouraging: that PDT reduced the polymicrobial organisms by >99.9% after just one treatment.

The scientists are careful to point out that their work was done in the lab where they duplicated the structure of the sinus cavities and populated them with the relevant microorganisms. However, because of the promise shown by their work these past few years, human clinical studies are currently planned to assess the safety and efficacy of this treatment for CRS.

It would seem that the sooner the better. Researchers at The University of Pennsylvania in 2007 surveyed physicians who treat CRS and found 86% of them were unhappy with current treatments and said there was a need for something proven to be effective and safe: the >99.9% pathogen reduction rate reported by Biel would seem to fit that need.

Galileo’s theory of the universe was largely rejected in his day. He wrote to a colleague expressing his disappointment that he failed to make believers out of all “educated persons” in the scientific community. “My dear Kepler, what would you say of the learned here, who, replete with the pertinacity [stubbornness] of the asp [venomous snake], have steadfastly refused to cast a glance through the telescope?  What shall we make of this?  Shall we laugh, or shall we cry?”  (Emphasis supplied.)

We can imagine, perhaps, that Galileo, if he were able to observe things today, would hope that the scientific community would at least “glance through the telescope” of Biel’s work. Based on his success so far, we can also imagine 37 million Americans and their families who might hope for the same thing.

Overcoming Resistance: The Case for Photodynamic Therapy

Towards the Light

At the corner of Blegdamsvej & Tagensvej, near Copenhagen University Hospital (“Rigshospitalet”) in Copenhagen, Denmark, stands Towards the Light, a large sculpture of 3 bodies straining towards the sun.  It was put there in honor of Danish scientist Niels Finsen who, in 1903, was awarded the Nobel Prize in medicine for his pioneering work in phototherapy in the treatment of disease, especially lupus & tuberculosis.  Finsen was more than just a scientist doing research – he had a dog in the fight. At only 42 and working from a wheelchair because of disease that attacked his internal organs, he was desperate to find a cure. Unfortunately, he died just one year later, at age 43.

His work though, lives on. No just in the Finsen Laboratory, named in his honor, at Copenhagen University Hospital, but also in the form of photodynamic therapy (PDT) for which his groundbreaking work paved the way.

Photodynamic therapy is the current form of Finsen’s phototherapy. It uses light-sensitive compounds that are exposed selectively to light, whereupon they become toxic to targeted cancerous and other diseased cells. Though relatively unknown, it is making strides into the worldwide medical community.

For example, in July of this year, the Vancouver General Hospital received an international innovation award for its groundbreaking infection control research from the International Consortium for Prevention and Infection Control (ICPIC) in Geneva. More than 5,000 patients were treated, reducing post-surgical infection by almost 40 per cent and saving the hospital $1.3 million in post-surgical infections and re-admissions. The research team, led by Dr. Elizabeth Bryce, competed against 40 international teams to win the prize. The hospital used a process called nasal photodisinfection (MRSAid) to kill harmful bacteria prior to surgery during a 12-month pilot project.

In the United States, the National Cancer Institute’s Factsheet tells us that PDT is used for certain kinds of lung and esophageal cancer, and that its researchers continue to study ways to improve the effectiveness of PDT, and expand it to other cancers of the brain, skin, cervix, prostate, cervix, stomach, and liver.

Yet despite this noble beginning, international recognition, and the endorsement of the NCI, PDT in its various applications remains very much underused. A case in point is its potential use in treating chronic sinusitis (CRS), one of the most common medical complaints in the United States, affecting up to 16% of the population. It is associated with over 13 million physician visits per year and an estimated aggregated cost of over $6 billion annually.

Moreover, the community of physicians who deal with CRS are not happy with current treatment options.  In a 2007 study published in The Journal of Allergy and Clinical Immunology, 202 doctors were surveyed from the US, UK, France, and Germany. 86% said they were generally unhappy withcurrent treatment; the same number wished for more options to treat the surgery refractory population; 91% reported they wanted a treatment proven as efficacious and safe; and, 88% of the respondents agreed that those patients with CRS refractory to surgery suffer from a severe and debilitating condition.

Indeed, in a separate study conducted in 2010 by the University of Pennsylvania, CRS sufferers were found to have worse quality-of-life scores than those suffering from chronic obstructive pulmonary disease, congestive heart failure, back pain, or angina.

The study summary concludes by saying that “… new therapies will undoubtedly play a greater role and change our treatment paradigms.” Such a PDT paradigm exists to treat CRS – it is called Sinuwave, and is vastly underutilized.

Surgeon Christian Betz from Munich’s University Hospital was interviewed by Optics.Org this past May about the under-utilization of PDT. He explained that “PDT is not widely accepted, because it does not fit the traditional way of thinking,” meaning that the vast majority of his peers are simply trained to use surgery when they see something in the body they want removed.

Rigid thinking sometimes dies a slow death, even in science. When Galileo said the Earth revolved around the sun and not the other way around he was thrown in jail. Nineteenth German doctor Ignaz Simmelweis found that you could reduce death rates in hospital obstetric wards from 35% to less than 1% by the mere expedient of doctors washing their hands. The reaction from other Western European doctors? They were offended by the implication that they were “dirty” and for decades went from surgery to surgery literally carrying the blood from the previous patient to the next one.  And of course there’s Darwin, whose mid-nineteenth century “theory” of evolution is still being contested, especially in parts of the U.S.

We are used to thinking of pathogens, bacteria especially, as having the trait of resistance. As it turns out, it is a trait shared by them and us – in both cases to the detriment of our species.

 

 

 

 

 

 

Sinuwave™ Photodisinfection for Invasive Fungal Sinusitis of Immunocompromised Patients

Acute invasive fungal sinusitis is the most aggressive form of fungal sinusitis. It is most commonly seen in immunocompromised patients and is the source of significant morbidity and mortality. Common causes of immunosuppression are diabetes, advanced AIDS  and neutropenia (low levels of white blood cells (neutrophils) in the blood). Patients with neutropenia include those with solid organ transplants, bone marrow transplants, leukemia, radiation therapy, chemotherapy, and any medication that affect bone marrow.

Ordinarily, fungi feed on dead organic matter, but not live human tissue. In the case of weakened immune defenses, however, fungi are able to attack and invade human tissue, hence the name “invasive fungal infections”.  With the patient having limited immune defenses, this invasive fungal infection can spread rapidly into the blood vessels, eye area, and central nervous system with devastating consequences. Within a few weeks, the disease results in vascular invasion and systemic dissemination. Roughly 12.5% of those with diagnosed fungal rhinosinusitis have invasive fungal rhinosinusitis- acute or chronic. Acute invasive fungal sinusitis is a rare condition with a high mortality rate when not recognized early and treated aggressively.

The key to successful outcomes is early detection and aggressive intervention. Invasive fungal rhinosinusitis is currently treated by aggressive medical (systemic antifungals) and surgical debridement to remove infected tissue in the sinuses using endoscopic sinus surgery. Sinuwave™ Photodisinfection, a non-invasive light activated therapy,  offers an effective alternative or adjunctive therapy for these vulnerable patients suffering from invasive fungal sinusitis. Photodisinfection has been proven to be safe over many years of experience in the dental and hospital acquired infection markets, and has proven to be highly effective at eliminating fungal organisms.

Sinuwave Photodisinfection System to Augment Current Endoscopic Sinus Surgery and Balloon Sinuplasty Procedures

When patients with Chronic Rhinosinusitis (CRS) are not responsive to medical therapy, they may be candidates for an endoscopic procedure that includes endoscopic sinus surgery, balloon sinuplasty, or a hybrid of a combination of these two. Endoscopic sinus surgery involves identifying and removing blockages of the sinus passages using high definition cameras, monitors, and a host of tiny articulating instruments. The operation is commonly performed with a general anesthetic, with instruments that access the sinuses through the nose, and only involving incisions of the face for the most severe of conditions.

The combination of endoscopic procedures and Sinuwave may help improve patient outcomes with minimal tissue removal. Balloon sinuplasty is also a surgical intervention but operates on an entirely different principle. It uses a balloon on a wire catheter to attempt to dilate the sinus passageways, widening the walls of the sinus passageway with the goal of restoring normal drainage without permanently damaging the sinus lining. Side-effects such as scarring of sinus tissue is unlikely using sinuplasty, unlike with surgery, but both of these current procedures are unable to address the underlying cause, only the blockages.

Hybrid procedures, which are becoming more popular as a result of improved patient outcomes, deploy both surgery and sinuplasty. Whether hybrid, surgery or sinuplasty, patient results can be further improved by the addition of Sinuwave™ Photodisinfection technology to remove the fungal and bacterial biofilm infections as well as their virulence factors within the sinuses, in addition to inactivating the host inflammatory cytokines. This 3 prong advantage of Photodisinfection enables ENT’s the ability to clear out the source of infection, and not just remove the blockage of the sinus passages. By clearing out the sinus cavities with several logs of kill, the body has a greater chance of returning to better health and avoid long term pain.

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