This is Andy Shorr, from Washington, DC, with a pulmonary and critical care literature update. Today I want to discuss a study by Schaffer and colleagues that was published in the March 3 issue of JAMA. These authors compared outcomes of single- and double-lung transplant recipients with idiopathic pulmonary fibrosis (IPF) or chronic obstructive pulmonary disease (COPD).
The use of double-lung transplants has been controversial because, of course, transplanting both lungs when it is not needed wastes a scarce resource. Historically, however, much of the literature has suggested that double-lung transplant outcomes are better, particularly in patients with IPF and COPD, perhaps because of underlying bronchiectasis or the improved functional reserve that comes with two lungs vs one. Many of these studies derived their data from the UNOS (United Network for Organ Sharing) or Lung Transplant Registry, and many of the earlier studies exploring this question were completed before we had the lung allocation score.
Previously, length of time on a waiting list was the main driver in terms of whether a patient received a lung transplant or not, and patients with IPF got a 6-month credit on the waiting list. More recently, the system for lung allocation has moved to one that is very similar to the system used for liver transplants, where the goal is to try to balance the risk for death while waiting for a lung transplant, against the benefit of receiving a lung transplant, to optimize outcomes for everyone in the pool.
Even after applying this lung allocation score, many patients with IPF or COPD receive bilateral lung transplants; however, many also get single transplants. The question is, what is the best way to allocate these scarce resources?
These investigators went to the UNOS registry to look at outcomes of patients after lung transplant as a function of whether they had IPF or COPD and whether they received a single- or double-lung transplant. They specifically compiled cases during the era of the lung allocation score, where some effort to balance risk and benefit has been integrated into the allocation of these scarce resources.
These authors looked at outcomes in about 4100 patients with IPF and 3100 patients with COPD. In an unadjusted analysis, the overall outcomes were good compared with historical outcomes, with median survivals above 50% at 5 years, regardless of whether patients received a single-lung transplant or a double-lung transplant, and of whether they had COPD or IPF.
When they looked specifically at patients with IPF, the unadjusted analysis found a survival advantage associated with double-lung transplant vs single-lung transplant. The Kaplan-Meier curves remained separated from the moment of transplantation forward. They also conducted an adjusted analysis that was propensity score–matched, to try to “pseudorandomize” the data to take into account the probability of getting one kind of transplant vs another. In addition, they looked at various important confounders such as the presence of pulmonary artery hypertension. This adjusted analysis showed a clear survival benefit associated with the double-lung transplant in patients with IPF: approximately 65-month survival vs about 50 months in IPF patients who received a single-lung transplant. That is a 15-month benefit and was statistically significant.
In the patients with COPD, the story is a bit more nuanced. The unadjusted analysis showed a benefit of double-lung transplant vs single-lung transplant in the population with COPD. However, the adjusted analysis—a careful, very nuanced statistical examination—found that the net benefit of a double- vs single-lung transplant was reduced to only 4 months. This was no longer statistically significant—not even close. It was also clear that there was a major interaction between double- and single-lung transplants, type of underlying disease (IPF or COPD), and eventual outcome.
These data are quite thought-provoking. It is a large analysis conducted during the lung allocation score era, and the investigators were very careful with their statistical modeling.
I believe that these results should begin to change our lung transplant practices. We need to derive better ways to sort out who needs a single-lung or a double-lung transplant. In patients with IPF, these data suggest clearly that the double-lung transplant is probably the right way to go. For patients with COPD vs historical controls, we do not have good data to show that there is necessarily any survival benefit associated with lung transplantation. For COPD, we need to step back and reevaluate the double- vs single-lung question, and perhaps use datasets similar to this to ascertain which patients benefit from a double- vs a single-lung transplant instead of simply saying that all patients with COPD are the same. Perhaps we should come up with scoring tools that are validated in external and other datasets across the globe to finally say which COPD patients, if any, benefit from double-lung transplant over single-lung transplant.
The article is in the March 3 issue of JAMA. This is Andy Shorr, from the Washington Hospital Center.
More than 6,000 liver transplants, a delicate operation that hinges on timing, are performed each year in the United States. Now, researchers at the RIKEN Center for Developmental Biology have developed a new technique that extends the time that donated organs last and so should increase the pool of available time-sensitive organs. The procedure cools livers down to 71.6 degrees Fahrenheit while still supplying oxygen, resulting in more successful transplants than the current standard.
One catch: The method requires more finesse and testing before becoming available for humans, says lead author, Dr. Takashi Tsuji, a scientist who specializes in organ regeneration. “Optimizing the scale of the system for humans while still making it portable will likely take about three years,” he stated in a press release. “Once that is accomplished, we should be able to begin the first human trials within a year or two.”
Left to right: a natural liver, a liver preserved at 22°C, a liver preserved at standard 4°C.Courtesy of RIKEN.
Read more via (http://www.medicaldaily.com/after-liver-failure-new-method-preservation-keeps-transplant-organs-healthy-330298)
Source: Ishikawa J, Oshima M, Iwasaki F, et al. Hypothermic temperature effects on organ survival and restoration. Scientific Reports. 2015.
She has spent every single day of her life in the hospital. After a heart transplant, Baby Iggy is spending her first night at home with her family.
“Everybody calls her their inspiration because she’s been through so much,” said Alicia. “All the nurses love Iggy and treat her really well, when I can’t be here…they’ve been…It really means a lot.”
Meet Ingrid Jaqueline Borer…or as her family calls her, “Iggy.”
Iggy came into this world early–33 weeks-along side her twin brother, Harlan.
Iggy has congenital heart defects and has spent every day of her life at Children’s Hospital and Medical Center.
Alicia McKelvey, Iggy’s mom said, “We thought we were just going to go through a few surgeries and then get her heart fixed…it turns out her heart was not going to cut it.”
Iggy would need a heart transplant. It was news her parents never expected to hear.
Nicholas Borer, Iggy’s Dad said, “The best option was the transplant. It was a tough decision and ultimately it worked out.”
Barb Roessner is a PA and the Transplant Coordinator at Childrens.
She has been by the Borer family’s side since day one.
“It was very tenuous while she waited. She was very sick,” said Roessner.
The average wait time for babies around Iggy’s age is three months. However, with Children’s Hospital’s location, they are able to draw from donors all across the country.
“Our wait times here have been a lot shorter than the national average. Our first baby was 9 days, Iggy’s was two weeks. We had one that was 17 days,” said Roessner. “People like Nick and Alicia get a second chance at life for their daughter. They get to be a family and that wouldn’t be possible if people didn’t make the choice to become organ donors.”
Gavin Maxwell was allowed to shoot anyone, except for the people in white coats.
Sometimes he’d hide behind the nurse’s desk at St. Louis Children’s Hospital and ambush the men and women in scrubs with his Nerf gun. He always startled them. But they always laughed.
“All the nurses call dibs on who gets him as a patient,” his mother, Shay Maxwell, said. “For being in a children’s hospital, it was actually a lot of fun. Or, we made it as fun as we could.”
The 10-year-old Sheridan boy was born with a rare metabolic disease that causes liver failure. For most of his life, Gavin was able to do whatever he wanted: He was quarterback on his school’s flag football team, played basketball and walked the family’s three dogs with his older sisters, Taylin and Tayci.
But the red-headed boy with freckles and black-rimmed glasses couldn’t escape the disease he was diagnosed with at age 1. In March, after several months of enduring complications from the disease, Gavin traveled to St. Louis, where he received a new liver from a donor.
“All we know about him is that he was as big as me,” Gavin said.
In 2005, Shay and her husband, Willy, took Gavin to their pediatrician for his one-year wellness check. What was supposed to be routine turned into a wild goose chase. The doctor knew Gavin’s liver was enlarged, but he didn’t know why. Gavin’s parents took him to the children’s hospital in Denver.
Coordinators and a surgeon talk about their roles in helping patients through the organ transplant process.
OSHKOSH –It was an early August day last summer when Dick Hanusa and Michelle Schuerman were wheeled into the operating room.
After two years of waiting, Hanusa received a new kidney from a friend of his daughter at Froedtert & the Medical College of Wisconsin.
“It’s pretty amazing that somebody is willing to give another person an organ,” the semiretired Oshkosh man said Thursday.
A transplant can be a long road involving a host of medical tests, regular checkups and the wait for a suitable organ. In the middle of the process — which can range from months to years — are transplant coordinators, who describe themselves as part quarterback, part patient advocate and part cheerleader.
“There’s a lot of pressure, and it’s a different kind of nursing,” said Deb DeWees, a registered nurse and pre-kidney transplant coordinator at Froedtert & the Medical College of Wisconsin. “It’s more of a counselor-type of nursing than an intensive care unit-type of nursing. … People that do this job need to have the ability to stick with the job for the long term, to see the big picture and to be patient.”
Coordinators not only help patients navigate the medical evaluation and getting on a waiting list, they also help recipients remain ready for when an organ becomes available.
“It’s my job to make sure they’re doing as well as they can, both physically and emotionally until they they get transplanted,” said Ann Wade, a registered nurse and certified transplant coordinator with Aurora St. Luke’s Medical Center in Milwaukee. “People wait for a transplant, and they wait quite awhile, so part of my job is to keep the morale up as best as I can and help them work through the process of waiting.”
April is Donate Life Month. Gannett Wisconsin Media is partnering with Froedtert Hospital & the Medical College of Wisconsin and the Green Bay Packers’ Randall Cobb to raise awareness about the issue. About 2,300 people in Wisconsin — and 123,000 nationally — are in need of a transplant. The four transplant programs in Wisconsin say the need for organs is a long-term issue expected to continue.
“What’s heartbreaking are some of the patients that have been on the list so long. Three years or five years, and they’re still waiting,” said DeWees, who grew up in Allouez near Green Bay.
“The longer you’re dealing with patients, you do become very emotionally invested in them,” DeWees said. “The highlight of my job is when I come in and get the email that one of my patients who has been listed for such and such a time has been transplanted. That’s the reward.”
On average, about 21 people a day die while waiting for a transplant, according to the Organ Procurement & Transplantation Network. Through April 10, 2,577 transplants have been performed this year using organs from 1,257 donors.
Transplant coordinators are one player in a larger team that can include dozens of medical professionals ranging from organ specialists and transplant surgeons to a transplant pharmacist, schedulers, psychologists and financial coordinators. The job is intense and stressful. But it’s the patients and their families who make it worthwhile, the medical professionals said.
“I’ve been at St. Luke’s for 23 years — and have been a coordinator for 14 years — and it’s the patients, getting to know them, their stories, and seeing them get a transplant and have a happy and healthy life afterward,” Wade said. “It’s also seeing those patients that aren’t going to make it and being able to help them, and the family, through that process, and helping them heal.”
Aurora St. Luke’s started its program in 1968 and counts more than 800 transplants in the last 47 years. While operations are performed in Milwaukee, the hospital system maintains a transplant coordinator at Aurora BayCare Medical Center in Green Bay.
Dr. Frank Downey, surgical director of cardiac transplants and mechanical circulatory support at Aurora St. Luke’s, said there’s a long-term gap between available organs and patients in need.
“The need is phenomenal,” Downey said. “At any one time in the country there are 3,500 patients waiting for a heart transplant. Since the early 1990s, only 2,300 heart transplants are done per year in this country because of the limitation on the number of donors available.”
Mechanical equipment, like left ventricle assist devices, are used to keep patients alive while suitable donors are found. Downey said each donor heart is carefully evaluated and compared against a list of waiting patients.
“We try to maximize every donor,” he said. “We get calls every day. Some years we get 1,000 calls in a year. Last year we were around 500.”
The transplant team seeks organs within a three-hour travel window of the hospital.
“With Lear jets and such, we’ve gone as far west as Albuquerque, N.M., as far south as Melbourne, Fla., and to the East Coast,” Downey said. “We’ve even gone into Canada a few times.”
One of the hospital’s doctors travels to the donor site, evaluates the heart and surgically removes it before flying back to Wisconsin. There another surgeon has prepared the recipient and will perform the transplant.
“It’s never routine,” Downey said. “Every patient is a story … and it’s incredible what these people go through.”
With such an intense process, DeWess, Wade and Downey said it’s impossible not to make connections with the people they are helping.
“I’m very emotionally involved, probably a little bit more than I should be. Our patients get sick and we spend a lot of time with them on the phone and in the clinic, and we go see them in the hospital,” Wade said. “It’s tough sometimes because you get to know them and their families, and you really become a transplant family. We’ve had a couple patients that were called in multiple times and you have to put on the cheerleader hat and keep going.”
Downey has done close to 100 heart transplants in the last five years. He said the operation remains an amazing process.
“I still get excited when I get a call that we’re going to change somebody’s life,” he said. “We know all these families, we know what it means to them and how it’s going to impact their quality of life. It’s kind of magical. You live and die with these patients. It takes its toll.”
Hanusa, 66, came out of surgery after almost five hours with news his newly transplanted kidney was functioning and that Schuerman, his donor from Franklin, was doing well.
“It’s been pretty amazing. Prior to the surgery my kidney function was down to about 10 percent,” he said. “I was tired and fatigued all the time, I just didn’t have any energy … Once I got the new kidney I was amazed at how wonderful I felt and the energy, it’s like turning on a light switch.”
Both Dick and his wife, Rita, say they are awed by Schuerman’s generosity.
“My comment was, ‘You gave my husband his life back,'” Rita Hanusa said. “I count my blessings every day that he’s still here and that he’s doing as well as he’s doing. I thank Michelle every day.”
Nathan Phelps may be reached at (920) 431-8310 or firstname.lastname@example.org. Follow him on Twitter @nathanphelpsPG or Instagram at Nathan_Phelps_PG.
On the web
•Donor registry: yesIwillwisconsin.com
•Froedtert & the Medical College of Wisconsin: froedtert.com/donatelife
•Aurora St. Luke’s Medical Center: www.aurorastlukes.org
FAIRFIELD — Louise Ward and Jordan Terry have never met.
Both are waiting for kidney transplants. But their stories are quite different.
Ward, a Suisun City resident, underwent a transplant last summer. Her body rejected the new kidney.
Something went wrong during her second surgery to remove the organ. When she awoke, she had encephalopathy. There was fluid on her brain and she couldn’t talk or walk.
She’s undergone extensive physical, occupational and speech therapy. Now she’s back on the transplant waiting list.
Ward was in her early 20s when things started to go awry with her kidneys. Things took a turn for the worse about five years ago and she began dialysis.
Now, every night before she goes to bed, she’s hooked up to a machine that does dialysis while she sleeps. By her side is her husband of 20 years, Anthony Ward. The couple have no two-legged children but love to dote on their four-legged canine, Fritz.
“Every day is another gift,” Anthony Ward said.
It’s still difficult for the couple to talk about what happened after the first transplant. They say it was their faith in God that got them through it.
That’s where their hope lies again.
“We are moving forward in Jesus’ name,” Anthony Ward said.
Miracles from God is the only way to explain how Louise Ward didn’t need a third surgery for internal bleeding, Anthony Ward said.
“God was moving in that place,” he said of the hospital.
Louise Ward said she’s always wanted to educate people about taking care of the kidneys, she just didn’t know it would be as a person who needed a kidney. Anthony Ward is on the same page as his wife.
“I want to help families avoid what we went through” he said. “Tell them to do more research on a transplant organ.”
Louise Ward, who is in her early 50s, was given a kidney from a 3-month-old baby. The Wards wonder if that made a difference in how her body handled the donated organ.
“It was all new to us,” Anthony Ward said. “We were so happy and excited that she was getting a kidney transplant.”
An April 25 fundraiser is planned to help with Ward’s transplant-related expenses. She plans to share kidney donor information with those who attend.
Those who can’t attend the fundraiser can mail donations to Travis Credit Union, attn: MSA Dept., P.O. Box 2069, Vacaville, CA 95696.
“With everything that has happened to me, it is confirmation that I have to use my injury to educate the community concerning renal failure,” she writes in a biography that she shares with others.
Jordan was introduced to Daily Republic readers in March 2014. The young boy, who turns 3 at the end of August, has a donor.
Residents will soon be bouncing off the walls, getting serious air and feeling the wind in their hair to help a local teen needing a heart transplant.
Trevor Sullivan, 14, of Southfield, learned earlier this year that he was in need of a heart transplant after battling a seemingly never-ending cold.
The staff at AirTime Trampoline & Game Park will hold a fundraiser from 4 p.m.-9 p.m. April 24 at their location in Troy, at 662 E. Big Beaver Road.
Trevor’s father, Phillip Sullivan, said he and his wife, Kimberly, didn’t expect that a stubborn cold would reveal that their son has an undiagnosed heart defect.
“We didn’t really think anything of it,” Phillip said of the cold.
When it all started, Sullivan said, his son was a relatively healthy young man and even played eighth-grade football at Berkshire Middle School in Birmingham.
After several trips to the doctor to try to defeat the cold, Phillip said, Trevor was diagnosed in February with an enlarged heart, and it was determined that he needed a heart transplant.
“We were kind of wishing or hoping for the best-case scenario,” Phillip said. “They felt his case was bad enough to have a transplant. It was the news we were kind of expecting but didn’t want to get.”
Phillip said the cost of the transplant is in the $300,000 range, not including hospital fees. The family’s medical insurance will cover some of the expense, but not all, he said.
Phillip said his family wants to set aside some money for a future transplant down the road for Trevor, as his doctors said this one will only last him about 15 years.
“We want to set aside some money for after this is all over with. A cushion for the future,” Phillip said.
As of press time, $39,270 had been raised for Trevor’s transplant.
When AirTime Trampoline & Game Park sales manager Melissa Morris heard Trevor’s story, she knew she had to step in to help.
“Here at AirTime, we have a trampoline park, but it’s more than that. We want to serve the community,” Morris said. “Jumping on trampolines is great for your heart, so we’re hosting Jump for Trevor to raise money for his heart transplant.”
Morris said the goal of the Jump for Trevor fundraiser is $20,000.
Phillip said his family is grateful for the support of the community.
“It’s just a great community. Everybody has come together and opened up their arms to us,” Phillip said.
Morris said pre-registration for the event is encouraged. Interested participants can go to air timetrampoline.com and click on the Troy location. From there, click “Reserve jump time,” and select 4-9 p.m. The cost for the fundraiser is $25 for two hours of jumping.
People interested in donating to the Jump for Trevor fundraiser but who are not interested in jumping can simply click “Trevor (NO JUMP)” after the time is selected and make a donation directly.
To donate to Team Trevor and the Sullivan family, go to gofund me.com/TEAMTREVORSUL LIVAN. For a full list of upcoming fundraisers for Trevor Sullivan, visit facebook.com/groups/TeamT revor.
CareDx (NASDAQ: CDNA) announced new evidence that the proportion of cell-free DNA (cfDNA) derived from the transplanted organ and found in the bloodstream of the recipient is correlated to the rejection status of the organ. Furthermore, this new biomarker (cfDNA) in combination with AlloMap®, the Company’s molecular diagnostic surveillance solution, provides greater accuracy of identification of rejection in heart transplant recipients than either test alone.
The analyses of blood samples from a subset of patients from the multicenter Cardiac Allograft Rejection Gene expression Observational study II (CARGO II) heart transplant observational study represent the first time that researchers have measured both cfDNA and gene expression profiles (AlloMap) in blood samples taken from the same patients. Dr. Maria G. Crespo-Leiro, a cardiologist from Hospital Universitario A Coruna in Spain, presented the results today at the 35th Annual Meeting and Scientific Sessions of the International Society for Heart and Lung Transplantation (ISHLT) held in Nice, France.
“While we’ve known that AlloMap can be used to rule out rejection in selected patients, now we have evidence that cfDNA is a promising biomarker to further assess the likelihood of heart-transplant rejection. These two non-invasive blood tests are complementary to one another and promise to further increase our knowledge of the status of a transplant recipient,” said Dr. Crespo-Leiro.
Researchers found that the proportion of donor-derived cfDNA in blood was significantly higher (about 1.7 fold higher, P=0.017) in patients who had a biopsy-confirmed rejection compared to blood transplant recipients who did not have rejection at the time of blood sampling. The mean AlloMap score was on average 4 points higher in patients with biopsy-confirmed rejection than AlloMap scores in patients with no rejection (P=0.007).
The clinical performance of a combination of the two tests resulted in a 10 percent increase in overall accuracy compared to the performance of either of the tests alone.
James Yee, MD, PhD, Chief Medical Officer at CareDx said, “The clinical use of AlloMap has continued to grow since its recommendation for non-invasive monitoring of acute heart transplant rejection in the 2010 ISHLT evidence-based guidelines for patient care. The new results presented today are exciting because they show the promise that the management of patients may be further enhanced when information from cfDNA is added to the AlloMap score. cfDNA levels rise as a signal of damage to the cardiac cells whereas the AlloMap score reflects the relative activation of the recipient’s immune system: these two signals provide complementary information that is helpful to more accurately estimate the risk of rejection at the time of testing. CareDx is sponsoring an ongoing study, named D-OAR, to further confirm the clinical performance of the cfDNA along with AlloMap.”
A replay webcast of the media briefing, “Further Advancements of Cell-Free DNA as an Important Biomarker for Transplant Recipients – CARGO II Study and Beyond” will be available on the Investor section of the CareDx website: www.caredx.com.