Posts by Amy Skiba:
Occupational and Environmental Lung Diseases (Indoor Air and Health)
Yuh-Chin T. Huang, MD, MHS, Professor of Medicine, Duke University Medical Center, Durham, NC
Indoor Air Pollution
- Individuals spend a large fraction of their time indoors (up to 95%)
- Air conditioning is warmer climates and heater in colder climates
- Many sources of various airborne pollutants are present indoors
- Lower ventilation rates will lead to increased energy efficiency but also can lead to the accumulation of pollutants (including CO2)
Common Indoor Pollutants
- Particulate matter (PM)
- Carbon monoxide (CO)
- Environmental tobacco smoke (ETS)
- Volatile organic compounds (VOCs)
- Formaldehyde (engineered wood), paint, 4-phenylcyclohexene (carpet), flooring, phthalates (caulks and sealants)
- Biological pollutants
- Dust mites
- Allergens (plants, animals)
FACTORS AFFECTING INDOOR AIR POLLUTION-ASSOCIATED HEALTH EFFECTS
- Age: children, pregnant women, elderly
- Preexisting medical conditions: allergy, asthma, COPD cardiopulmonary diseases, immunocompromised host
- Individual sensitivity: genetic traits
- Exposure levels
- For long-term effects, there is considerable uncertainty about what concentrations or periods of exposure are necessary to produce specific health problems
- Main sources: diesel engines in trucks, buses, and non-road vehicles (e.g., marine, construction, agricultural, and locomotive)
- Indoor cooking/biomass burning
- For outdoor air, EPA NAAQS annual limit: 15 µg/m3 ; 24-hour limit: 65 µg/m3
- There are currently no federal government standards for PM2.5 in indoor air environments
Health Effects of Indoor PM
- Exacerbations of existing respiratory diseases
- Development of chronic lung diseases
- Lung cancer (diesel exhaust)
- Cardiovascular mortality and morbidity
- Increased susceptibility to respiratory infections
- Systemic adverse effects
- Indoor levels typically track the outdoor levels
- Indoor sources
- Laser printers, copying machine, air cleaners with electric or ion generators
HEALTH EFFECTS OF INDOOR OZONE
- Exacerbations of existing respiratory diseases
- Increased susceptibility to respiratory infections
VOLATILE ORGANIC COMPOUNDS (VOCS)
- Organic chemicals that have a high vapor pressure at room temperature
- Sources including:
- Paints, paint strippers, and other solvents
- Wood preservatives
- Aerosol sprays
- Cleansers and disinfectants
- Moth repellents and air fresheners
- Stored fuels and automotive products
- Hobby supplies
- Dry-cleaned clothing
- Levels of VOCs are in general 2 to 5 times higher indoors than outdoors
- There are hundreds of VOCs
- The only VOCs the federal government regulates (as a carcinogen)
- OSHA (PEL of 0.75 ppm, and an action level of 0.5 ppm)
- HUD (0.4 ppm for mobile homes)
- Sources: Building materials, smoking, household products, and the use of un-vented, fuel-burning appliances (gas stoves or kerosene space heaters), pressed wood products made using adhesives that contain urea-formaldehyde resins
- In developing countries: mosquito coils, solid fuel
- During the 1970s, many homeowners had urea-formaldehyde foam insulation (UFFI) installed in the wall cavities of their homes for energy conservation
Health Effects of Formaldehyde
- Watery eyes, burning sensations in the eyes and throat, nausea, and difficulty in breathing in some humans exposed at elevated levels (above 0.1 ppm)
- High concentrations may trigger attacks in people with asthma
- Some people can develop a sensitivity to formaldehyde
- Cause cancer in animals and may cause cancer in humans
- Ubiquitous to the environment
- Thousands of known species of molds
- Very tolerant to temperature and humidity extremes
- When visible to the unaided eyes, molds have formed large colonies
- Most are not pathogenic but can cause disease in immunocompromised hosts
Health Effects Associated With Molds
- Exacerbation of asthma
- Upper respiratory tract symptoms (cough, wheezes) in normal individuals
- Hypersensitivity pneumonitis: farmer’s lung, humidifier fever, compost lung, etc
- Pneumonia (especially in immunocompromized hosts)
- Sick building syndrome (?)
WHEN TO SUSPECT POOR INDOOR AIR QUALITY?
- Perennial sinus congestion
- Recurrent respiratory infections
- Repeated positive respiratory cultures of environmental molds
- Water stains/roof leaks/flooding
STRATEGIES TO IMPROVE INDOOR AIR QUALITY
- Source control
- Improved ventilation
- Air cleaners (air purifiers) with HEPA filters
- Corsi-Rosenthal box
- Check gas stoves, and appliances regularly
- Change vent filters regularly (HEPA filters)
- Be vigilant about the presence of molds
- EPA: A Brief Guide to Mold, Moisture, and Your Home (http://www.epa.gov/mold/moldguide.html)
- Decrease mold exposure
- Avoid compost piles, cut grass, and wooded areas.
- Control moisture
- Dehumidifiers, air conditioners
- Opening windows and doors, operating window or attic fans, when the weather permits
- Especially important for short-term activities that can generate high levels of pollutants — painting, paint stripping, heating with kerosene heaters, cooking, or engaging in maintenance and hobby activities such as welding, soldering, or sanding.
- Window air conditioner
Air Cleaners (Air Purifiers)
- Many different models
- Look for a percentage efficiency rate and cubic feet per minute
- Not for removing gaseous pollutants
Indoor air pollutants can cause immediate and long-term health effects, especially in susceptible individuals. Remain vigilant about changes in the indoor environment and make necessary remediation as early as possible.
Protect Indoor Air Quality in Your Home
What is spirometry?
- Spirometry is a test that measures lung function
- It is used in both disease diagnosis and monitoring of disease progression
- Spirometry is relevant for a number of respiratory diseases: ○ Asthma, COPD, Pulmonary Fibrosis, Cystic fibrosis, etc.
Spirometry in a clinic:
Traditionally, a spirometry test is performed in a healthcare clinic. During the test, patients are instructed to breathe into a tube connected to a spirometer. A patient is usually asked to perform a series of blows, and the clinician takes the best attempt and analyzes the results.
Key spirometry results
- FVC (forced vital capacity) – the volume of the entire blow, typically measured in Liters
- A low FVC value may be indicative of restrictive lung disease (i.e. IPF), as patients are unable to inhale fully
- FEV1 (forced expiratory volume, 1 second) – the volume of the first second of the blow, also measured in Liters ○ A low FEV1 value relative to FVC (FEV1/FVC) may be indicative of obstructive lung disease (i.e. COPD or Asthma), characterized by difficulty exhaling
Home spirometry – the early days
- Home spirometry has been in use since at least 1990 – 32 years!
- Early devices were quite different from the digital versions that are now available ○ Data was displayed directly on the device
- Most devices did not store the data
- None of the devices shared data with the clinical team automatically
- Patients were relied on to keep a paper diary
- FVC was not recorded on many early home spirometers
Digitization of home spirometry and implementation in remote patient monitoring
- There are now a number of Bluetooth or cellular-enabled home spirometers on the market which send data to your smartphone and/or clinicians
- Not all digital home spirometers have the same level of clinical validation
- Connected apps vary widely by features, function, and reliability
Spirometry is a key indicator of patient health post-lung transplantation
- Spirometry is commonly used post-lung transplant for follow-up care
- Typically, spirometry is done in a clinic (PFT Lab) every 3 months after a baseline is established during the first several months following the transplant
- Declines in key spirometry values, particularly FEV1 (but also FVC), may indicate complications:
- Bronchiolitis Obliterans Syndrome (BOS)
COVID-19 spike in digital health
The COVID-19 pandemic was a major catalyst for digital health adoption.
Some statistics based on an EY survey of 2000 patients and 300 physicians:
- In April 2020, 43.5% of Medicare primary care visits were telemedicine, compared to 0.1% in February 2020
- Use of telephone and video at physician practices increased from 20% (before) to 80% (during)
- 81% of physicians surveyed planned to accelerate introduction of new digital technologies
Digital health (including remote patient monitoring [RPM]) will remain “sticky” moving forward
- 2021 use of telehealth declined from it’s COVID-19 peak in 2020, but has leveled off at much higher levels than pre-pandemic
- CMS made major changes to telehealth and remote patient monitoring
- reimbursement in the last few years, allowing for increased adoption
- A 2021 survey from MSI international found that:2
- 80% of consumers are in favor of using RPM,
Key reasons being:
- Control over personal health
- Peace of mind
Remote patient monitoring (RPM) including home spirometry in lung transplant care
RPM may be used as part of a follow-up care plan after a lung transplantation.
Patients are supplied with medical devices (spirometers, pulse oximeters, weighing scales, etc.) and a connected mobile application to send “physiologic” data to their clinical team in between routine care appointments
In addition to physiologic data, patient reported outcome data (i.e. surveys about QoL, breathlessness, etc.) can be quite useful in capturing a more complete picture of patient well being
Care teams may review this data regularly for any alarming changes, or use it as a reference point during telehealth visits
Benefits of remote monitoring vs routine care
- Quicker identification of changes in physiologic values (i.e. FEV1) may indicate infection or rejection, and allow patients and clinicians to intervene appropriately to prevent or reduce the impact of these acute events
- Long term monitoring of spirometry and other data allow patients and their care teams to communicate more frequently and effectively, adjusting care plans accordingly
- Patients AND clinicians have better peace of mind, knowing that each other are actively participating in the care process even in between apts
- Fewer or less frequent in-person follow-up appointments may be needed, allowing patients the comfort and convenience of making fewer trips, and freeing up capacity for health systems
What are the costs and who pays for it?
- Home spirometers can vary widely in cost, but most handheld devices will likely be in the $100-200 range ○ Some of these devices are available direct-to-consumer and may interface with downloadable apps
- Remote patient monitoring programs are typically paid for by healthcare systems
- There are reimbursement codes available for RPM that the center would bill patients’ insurance for each month
Home spirometry has not come without challenges and controversy
One of the earlier publications in home spirometry (2001)concluded that:
“Even under ideal conditions, home spirometry provides an incomplete (and therefore potentially biased) picture of long term changes in pulmonary function.”
More recently in 2019, a study assessing the efficacy and safety of Pirfenidone in ILD patients was unable to draw any statistical conclusions due to variability in home spirometry data.
This was largely due to the lack of statistical controls for removing outlier values, but nevertheless, many questioned the accuracy of home spirometry.
How can we ensure high-quality home spirometry?
- The technology is improving, along with understanding about how/when/what to use home spirometry for
- Clinicians can analyze flow-volume curves to assess blow quality
- Home spirometry platforms can employ algorithms to assess quality in real time, or to coach patients through the process
- Coaching can be done via video consultation with a clinician when technique is under question
- 1-2 week “learning curve” for new home spirometry users
- Keep in mind the difference between “research quality” spirometry and the level of accuracy that is needed to track changes over time in a clinical or patient-led application
- Outlier values will occur and need to be accounted for (i.e. a patient might cough during a blow)
Sample IPF patient home vs clinic FVC, consented to share
Other possible cons of home spirometry or RPM
- Access to technology or internet may be limited
- Some patients may find it burdensome to track data, or it may increase anxiety or stress
- RPM and digital medicine in general cannot replace all face-to-face visits
- All insurance providers may not cover RPM
How can patients find the right home spirometer and platform for them?
- First, ask your care team if they have a remote monitoring program or if they recommend a particular device and platform
- Ask patient advocacy groups for recommendations
- Check for clinical studies validating the device and platform
- These can often be found on company websites, or use a site like clinicaltrials.gov to check for publications
- Read about the pros and cons of different devices/platforms on company websites
○ For example, do I plan to keep a log of other data (i.e. weight, symptoms)? Do I want a way to track my medications? What’s the cost of the device?
- Spirometry is a key tool for long-term follow up of lung transplant recipients
- Home spirometry is becoming an increasingly reliable method of making spirometry more accessible and convenient
- Remote monitoring technologies allow for home spirometry data to be shared easily with care teams, allowing for quicker identification of adverse events and peace of mind for all
- There is still work to do to ensure home spirometry accessibility, reliability, and affordability
The Lung Transplant Foundation to Host Externally-Led Patient-Focused Drug Development Meeting to Help Educate FDA on Living with Bronchiolitis Obliterans Syndrome (BOS)
Meeting to be Held Wed., June 22, 2022 from 10:00 a.m. – 3:00 p.m. ET in Washington DC.; Event will be Livestreamed for Virtual Attendees
Bronchiolitis Obliterans Syndrome (BOS) is One of the Most Severe Complications After Lung Transplantation; Currently, There are No Approved Treatment Options
An Estimated 50% of Lung Transplant Patients Develop BOS within Five Years Post-Transplant
The Lung Transplant Foundation (LTF), a non-profit organization dedicated to creating a world where all lung transplant patients live long, healthy lives, announced today it will host an externally-led patient-focused drug development meeting with the U.S. Food and Drug Administration (FDA) on Wednesday, June 22, 2022, from 10:00 a.m. – 3:00 p.m. ET in Washington DC. This historic event is intended to help educate the Agency and the public about the challenges of living with Bronchiolitis Obliterans Syndrome (BOS).
BOS, also referred to as chronic rejection, is one of the most severe complications after lung transplantation. Approximately 50 percent of lung transplant patients develop BOS within five years post-transplant, the highest rejection rate of any transplanted organ. BOS usually leads to respiratory failure and death within 2 to 4 years after diagnosis ii, underscoring the immense need for effective treatment options.
“This is the first time that regulators and policymakers on the Hill will hear directly from patients and caregivers about what it is like to live with BOS, a disease that represents an incredibly high physical, the emotional and economic burden on patients, their caregivers, and the healthcare system,” said Amy Skiba, executive director of The Lung Transplant Foundation. “We believe that understanding the patient journey can help the FDA make more informed decisions as they review potential therapies for BOS and will assist pharmaceutical companies in the design of clinical trials for BOS patients.”
The June 22 Meeting will be a Livestream and will include patient testimonials, as well as remote audience participation (register here). The meeting agenda will focus on two patient panels and audience discussion sessions on living with BOS, treatments for the disease, and potential clinical trials for BOS. LTF encourages patients and caregivers impacted by or at risk of developing BOS to take a brief survey here. The anonymous information gathered will be used to help guide and inform content for this meeting as well as future LTF activities.
“While lung transplants give recipients a second chance of life, unfortunately, an estimated 50 percent of recipients will develop BOS five years post-transplant and be faced with no approved treatment options,”
said John Michael Reynolds, M.D., associate professor of pulmonary, allergy and critical care medicine at Duke University School Medicine.
“As clinicians, we applaud the LTF for leading the way for transplant patients who have already faced an incredibly long and arduous journey with lung disease and eagerly welcome new therapeutic options to help change a patient’s prognosis, should BOS occur.”
The burden of BOS on the healthcare system is significant. Double lung transplantation costs in the U.S. are estimated to be over $1 million.iii Meanwhile, the per-patient mean direct costs in the U.S. for treating lung transplant recipients with BOS exceed $150,000 in the year following diagnosis compared to transplant recipients without BOS.iv
LTF would like to thank our participating sponsors, Altavant Sciences, patientMpower, Zambon USA Ltd., and Mallinckrodt Pharmaceuticals for helping to make this event possible.
About The Lung Transplant Foundation:
The Lung Transplant Foundation (LTF) was founded as a non-profit organization by a group of lung transplant recipients from Durham and Chapel Hill, NC. Since 2009, we have raised funds and have been an advocate for lung transplant research. We also provide education and emotional support for transplant recipients and their caregivers through our Mentorship.
We can’t do it alone. We invite you to help us breathe life into lung transplant research by making a donation or learning more about how you can be involved.
Amy Skiba, Executive Director, LTF
M: +1 570-815-4243
Media Relations Contacts:
Elixir Health Public Relations
M: +1 862-596-1304
M: +1 917-567-7136
i Weigt, et al. Semin Respir Crit Care Med. 2013;34(3):336–351.
ii Chambers DC, et al. J Heart Lung Transplant. 2018;37(10):1169–1183.
iii Milliman Research Report. 2017.
iv Sacks, NC., et al. J Heart Lung Transplant; 2020;39(4):S364-365. doi.org/10.1016/j.healun.2020.01.446.
The backstory on why we need your story
by Lung Transplant Foundation Executive Director, Amy Skiba
Eighteen months, 3 weeks and two days. That is exactly how long our organization had been urging the FDA to let us hold an Externally-Led Patient-Focused Drug Development (or EL-PFDD) meeting. And finally, on June 22, 2022, it happened and the FDA is all ears!
Many of you knew and were inspired by our organization’s founder, Jeff Goldstein. I was lucky enough to work with Jeff, if only for a short time. In 2009, he founded The Lung Transplant Foundation (LTF) for one reason—to help others who had undergone a lung transplant as he had—improve their chances of surviving.
When people asked why he founded the Lung Transplant Foundation, I can remember Jeff explaining,
“Since my transplant, I have lost several friends to rejection…I couldn’t wrap my brain around this rejection issue that took my friends so quickly and suddenly…and was quite likely to take me as well.”
His words were prophetic. Chronic rejection issues known as a condition called Bronchiolitis Obliterans Syndrome, or BOS (pronounced boss) ultimately took Jeff’s life in June of 2021.
In September of 2020, when the FDA first announced it would be holding Patient-Focused Drug Development Meetings, Jeff said,
“This is it! This is our chance to make our case!!”
Jeff knew that by putting names, faces and stories to BOS, we could really start gaining ground on effective therapies to treat it. He also knew that an externally-led PFDD meeting would be our only chance to get in front of the FDA and tell the stories surrounding BOS. He immediately went to work gathering the materials we’d need for our Letter of Intent.
Even toward the end of his life, when he was ailing, Jeff was laser-focused on persuading the FDA to agree to hold this meeting about BOS. Jeff and I finished up our Letter of Intent to the FDA on June 20, 2021. He passed away two weeks later. In July, we got the green light to have the June 2022 PFDD meeting.
You can imagine how bittersweet this happy news was for everyone who had known Jeff and worked with The Lung Transplant Foundation. The first step toward his primary goal had been accomplished but he lost his battle with chronic rejection before seeing it happen. Please help us carry on Jeff’s legacy by ensuring this pivotal meeting is well-attended.
I’m so happy that Jeff’s wife Martha will be speaking at the June 22 meeting to remind us about Jeff’s life, his wishes, and his goal for BOS to be vanquished.
So you see, not only is this June 22 meeting a dream realized, it is also a tribute to Jeff’s life. Participating in the meeting in any way you can is an action we can take to honor all those who have been sidelined or lost to this poorly understood condition.
If you have been touched by BOS, we want to hear from you. We want the FDA staff in attendance to hear directly from patients, their families, caregivers and patient advocates.
By doing so you will help us achieve Jeff’s vision, to help create a world where all lung transplant patients can live long, healthy lives.
Thank you in advance for anything you can do to help us make the most of this meeting.
John and his wife continue to collaborate, helping other patients and caregivers.
Written by John Gersh
On a hiking trip in the spring of 2006 my wife, Alice, found herself out of breath at the top of a steep hill and decided to skip the rest of that hike. We thought little of it at the time, but Alice has a family history of idiopathic pulmonary fibrosis (IPF), and concerns grew. Over the next eight years such incidents became more frequent and eventually she was diagnosed with the disease. There is no cure for IPF, and at the time there were few options for treatment. Alice had a fatal lung disease, one that can suddenly get much worse. In the spring of 2015, it did. Alice needed oxygen continuously, had little stamina, and her health generally declined. A transplant was the only option. She was finally listed for a lung transplant in July. I had become a full-time caregiver.
Caregiving entailed many things, some large enough to dominate one’s life, some small but memorable. The first included obvious things like managing oxygen deliveries and tank switching. It included some things not immediately obvious like learning how to provide the right level of emotional support. It meant being on call all the time. The small things included learning by trial, error, and correction exactly how Alice wanted her favorite breakfast of sausage and potatoes prepared, since she couldn’t do it herself. People may be demanding and grumpy as they lose their autonomy; caregivers learn that it’s not personal.
Caring for a transplant patient is a team effort. Alice and I were at the center; we faced the challenges together. We were surrounded by a wonderful group of relatives and friends: they stood in for me to give me respite; they brought meals and went shopping; they listened to my worries and Alice’s. At one point I needed outpatient surgery. The operation was minor, but it meant that I couldn’t drive or lift heavy weights for a month. What if we got “The Call” that a lung was available and we had to get to the hospital immediately? The team responded. We designated a backup crew, and they practiced all the steps involved in taking Alice to the hospital. As it turned out, the backup crew wasn’t needed, but having one was important to Alice’s care and to my own well-being. We were also supported by the transplant team at Johns Hopkins Hospital; they were a phone call away. Interacting with them was also part of caring for Alice.
By December 2015, Alice was doing very poorly. We couldn’t give her as much oxygen as she needed at home, and she was admitted to the hospital. I felt that this was it: she would come home with a new lung or not at all. On the morning of the second day there, the transplant surgeon came to her room and announced that a lung was available. (He felt that at that point she was too frail to endure the longer surgery needed to transplant both lungs.) By early the next morning the surgery was over. Two days later her oxygen cannula was removed. There was no ceremony, yet it was a milestone; there would be more challenges ahead, but I knew then that she would make it.
Of course, caring for Alice didn’t stop; it just entered a new phase. Recovery was tough, but she remained determined. The care team was still needed, but gradually faded into the background. Caring itself also diminished as she could do more on her own. In August 2016, Alice threw a big party for all of the people who had supported her over the past year – the care team and more. She gave a nice speech thanking everyone and ended by acknowledging the person to whom she owed the most: her donor.
A couple of years later, we had an opportunity to give something back to the transplant community; we volunteered as mentors with the Lung Transplant Foundation, Alice for lung transplant patients, I for their caregivers. We became part of an even larger team and have found it rewarding to share our experiences and, we hope, helpful.
Caregiving teamwork stays with you. Every Saturday Alice and I team up to distribute into her pillbox the medications that keep her alive and healthy. A few months ago, Alice had some severe back pain and had to be taken to the emergency room. It resolved quickly, but in the moment, I found myself falling into what I call caregiver stance: only Alice’s situation mattered, other priorities diminished. Transport had to be arranged. People had to be notified. Medication had to be acquired. Meals had to be prepared. The team went into action, did its job, and stood down when the crisis passed.
John Gersh is a semi-retired engineer. He lives in Columbia, MD, with his wife, Alice. Alice had a single lung transplant in December 2015 at the Johns Hopkins Hospital in Baltimore, MD. John and Alice both like the outdoors, Alice knits, and John competes in Masters Track and Field Championships.
John and Alice Gersh are still active in the Lung Transplant Foundation Mentorship Program six years after Alice’s lung transplant.
Lung Transplant Foundation is joining forces with the Children’s Organ Transplant Association (COTA)
Lung Transplant Foundation is joining forces with the Children’s Organ Transplant Association (COTA) to assist lung transplant patients in need of fundraising expertise and guidance.
The Lung Transplant Foundation (LTF) receives many requests for funding support for lung transplant patients. Unfortunately, we do not provide patient funding as our mission is to support research, education, advocacy and mentorship. There are organizations based in the United States who provide various types of fundraising support once a patient has been listed for transplant at a U.S. transplant center.
LTF is joining forces with the Children’s Organ Transplant Association (COTA) to assist lung transplant patients in need of fundraising expertise and guidance. Founded in 1986, the Children’s Organ Transplant Association (COTA) helps children and young adults who need a life-saving transplant by providing fundraising assistance and family support. COTA is the premier national organization helping alleviate the financial burden for families who have a transplant-needy child or young adult. COTA also works with individuals of any age with single-gene disorders such as Cystic Fibrosis, Alpha-1, Polycystic Kidney Disease, or Sickle Cell Disease.
COTA will attempt to assist adult lung transplant patients diagnosed with a single-gene disorder who are referred by LTF. COTA will share information about fundraising for transplant-related expenses and will strive to identify grants and other resources through partner organizations. COTA’s services and guidance are provided at no charge to pre- or post-transplant patients or families.
Connecting with COTA is streamlined and simple. Visit https://cota.org/get-started/ or call 800.366.2682 to learn more:
- Submit your information to learn how COTA can help.
- Receive guidance and support. COTA’s transplant fundraising professionals will work with your volunteers to provide resources, ideas and materials.
- Launch a COTA fundraising campaign once your lead volunteer has been identified and trained … or possibly get a referral to another organization that can provide other types of support.
- Work with your volunteers to personalize and update the free-of-charge website COTA provides.
- Start sharing your transplant journey on the provided COTA website and on social media platforms.
Facing a lung transplant as either patient or caregiver is challenging and complex. It can often feel overwhelming, especially when it comes to the financial considerations. The Lung Transplant Foundation and COTA are here to help you navigate through this difficult journey.
Paragonix Technologies, the leading hypothermic cardiothoracic organ preservation provider, announced today the first-in-man clinical use of the only FDA cleared cold storage device for donor lungs, its LUNGguardTM Donor Lung Preservation System, by Duke University Hospital.
“Donor lungs are sensitive to injury and the current ice storage of lungs risks cellular injury, especially with the increasing transport distances and times now experienced by lung transplant centers,” said John Haney, MD, MPH, Surgical Director, Duke Lung Transplant. Dr Haney was the implanting transplant surgeon on the first four cases using the LUNGguard system. “Duke Health is committed to pioneering new innovations that benefit transplant patients and changing the way donor lungs are transported has this potential.”
The first-in-the-world use of the LUNGguard system preserved donor lungs for 7 hours on their journey to provide a patient suffering from Idiopathic Pulmonary Fibrosis (IPF) with new lungs. Since the initial first-in-man, the Duke team has performed an additional four lung transplantations using the LUNGguard System. These early cases have demonstrated the versatility of the device in multiple applications including DCD and DBD donors, total ischemic times from 3 hours to 12 hours, and indications varying from emphysema to cystic fibrosis.
The LUNGguard System represents a radical advance from ice and off-the-shelf coolers that has been the standard-of-care for over 50 years of organ transplantation. For the first time, transplant teams have access to an FDA cleared and CE marked hypothermic lung preservation device that can precisely maintain and monitor the environment necessary for donor lungs.
“At Carolina Donor Services, our mission is to maximize the passing of the heroic gift of life from one person to another through organ donation. We are constantly embracing new technologies that will help safeguard organs and ensure better outcomes for those patients waiting for the gift of life,” said Danielle Niedfeldt, President and CEO of Carolina Donor Services, the organ donation organization that supported these cases. “I am honored that our team could be part of the first-in-man use of the LUNGguard system and we are excited by its positive impact in lung transplantation and saving more lives.”
The development of this system has been supported by a collaboration between Paragonix and the Lung Transplant Foundation, a leading lung transplant patient advocacy group. “The LUNGguard device is a project that we have been working on with Paragonix for the past three years, because we saw the critical need for this technology in lung transplantation. To be able to help another IPF patient in the first-in-man case could not have been more significant to me personally,” said Jeffery Goldstein, President and Founder of the Lung Transplant Foundation and lung transplant recipient.
The LUNGguard System is the latest addition to the Paragonix portfolio of organ preservation and transport systems. It is built on the same proven technology architecture as the ParagonixTM SherpaPak Cardiac Transport System, which has been
widely adopted for heart transplantation over the past two years. Additionally, Paragonix has FDA cleared and CE marked systems for kidney, liver, and pancreas transplantation.
“Our team at Paragonix strives to provide donor organs and transplant recipients every possible advantage for a second chance at life,” said Lisa Anderson, Ph.D., Founder, President, and COO of Paragonix Technologies. “We are honored to partner with the team at Duke and Carolina Donor Services to reach this incredible milestone and begin
making an impact to as many lung transplant patients as possible.”
About Paragonix Technologies
Paragonix Technologies designs, produces, and markets organ preservation and transport devices that safeguard organs during the journey between donor and transplant recipient patients. Our award-winning devices mitigate risk in an otherwise high stakes environment by combining best-in class transplant products with a centralized communication and data transfer app to eable better coordination and efficiency during donor organ procurements. Paragonix SherpaPakTM CTS is the only commercially available FDA-cleared and CE-marked preservation and transport device for adult and pediatric donor hearts destined for transplantation. Paragonix is the sole sponsor of GUARDIAN, the largest international clinical data registry on heart preservation, capturing clinical outcome data on Paragonix SherpaPakTM CTS and all
other heart preservation technologies. Paragonix’s LUNGguardTM is the only FDA-cleared and CE-marked cold storage preservation and transport device for donor lungs and was commercially launched in the US and in Europe in December 2020. Paragonix is also developing preservation devices for pancreas, kidney and liver — designed to improve donor organ quality and extend donor organ preservation time.
- Understanding what a clinical trial is and how they work
- Understanding the barriers to the development of new therapies
- Hearing from a lung transplant recipient who has participated in a clinical trial
- Learning about how to find current clinical trials
Questions: email Jeff Goldstein at firstname.lastname@example.org