Physicians should give balanced information to their pregnant patients who are considering cord blood banking, presenting both the advantages and disadvantages of public vs. private cord blood banks, according to The American College of Obstetricians and Gynecologists (ACOG) in a revised Committee Opinion published today in the February issue of Obstetrics & Gynecology. ACOG also advises physicians who recruit patients for for-profit cord blood banking to disclose their financial interests or other potential conflicts of interest to pregnant women and their families.

Blood from a newborn’s umbilical cord, once considered a waste product that was routinely discarded along with the placenta, is now considered to contain potentially life-saving stem cells. Private banks were initially developed to store cord blood stem cells from newborns, for a fee, for potential future use by the same child or a family member if he/she developed disease later in life. Today, there are public banks that store, for free, stem cells that can be used by anyone needing them similar to how public blood banks work.

“Patients need to be aware that the chances are remote that the stem cells from their baby’s banked cord blood will be used to treat that same child-or another family member-in the future,” said Anthony R. Gregg, MD, chair of ACOG’s Committee on Genetics. ACOG’s Committee Opinion is a joint document produced by the Committee on Obstetric Practice and the Committee on Genetics.

Although ACOG takes no position for or against cord blood banking, it recommends that physicians disclose that there is no reliable estimate of a child’s likelihood of actually using his or her own saved cord blood later. Some experts estimate this likelihood at 1 in 2,700, while others argue the rate is even lower. Physicians should also disclose to their patients that it is unknown how long cord blood can successfully be stored.

Pregnant women should be aware that stem cells from cord blood cannot currently be used to treat inborn errors of metabolism or other genetic diseases in the same individual from which they were collected because the cord blood would have the same genetic mutation. “Cord blood collected from a newborn that later develops childhood leukemia cannot be used to treat that leukemia for much the same reason,” said Dr. Gregg.

Federal legislation was passed in 2005 that provides funding for continued growth of a national cord blood registry in the US. Several states have laws requiring physicians to inform patients about cord blood banking options. Physicians should consult with their state medical association for more information about their individual state laws.

Committee Opinion #399, “Umbilical Cord Blood Banking,” is published in the February 2008 issue of Obstetrics & Gynecology.

The American College of Obstetricians and Gynecologists is the national medical organization representing over 52,000 members who provide health care for women.

American College of Obstetricians and Gynecologists

Pulse cooximeters have long been used
to identify and measure the levels of carbon monoxide (CO) in the blood of
patients or firefighters. But new research, presented at CHEST 2007, the
73rd annual international scientific assembly of the American College of
Chest Physicians (ACCP), indicates that the device has another use — it
can quickly, inexpensively, and noninvasively identify a person who smokes.
The study argues that if smokers know their blood CO levels, they may be
more prone to quit or more likely to never start in the first place.

“By using this device in the office, the poisoning of the hemoglobin or
blood with carbon monoxide can be detected and shown to the patient before
they actually develop a clinical disease such as emphysema or cancer,” said
study author Sridhar P. Reddy, MD, MPH, FCCP, St. Clair Pulmonary and
Critical Care, St. Clair, MI. “In our practice, when the carboxyhemoglobin
is 10%, it’s easy to tell a patient that 10% of his or her blood is
poisoned and unable to carry oxygen. By doing this, we catch the patient’s
attention right away and can begin smoking cessation counseling.”

The study originated as a high school science project. Carried out by
Dr. Reddy’s son. At each outpatient visit, Dr. Reddy measured patients’
carboxyhemoglobin, blood poisoned by CO, and methhemoglobin, blood
transformed by other substances, such as nitrogen dioxide, with a pulse
cooximeter. And, as part of his project, his son, who was a sophomore at
Detroit Country Day School, developed and distributed questionnaires
regarding the patients’ smoking status.

“When I was searching for a science project, I realized that the
question of how much carboxyhemoglobin is needed to suggest smoking seemed
unanswered,” said coauthor and son Ashray Reddy. “I thought that by trying
to answer this question, I could help people quit smoking.”

Researchers used the pulse cooximeter, a device that is clipped to the
patient’s finger and reads the percentages of poisoned blood through a
light that is shined through the nail bed. A total of 476 patients who
visited the clinic participated. Patients were identified as a smoker,
based on a combination of their questionnaire responses and if they’re CO
levels exceeded 6% of their blood. Researchers were also able to identify
secondhand smokers based on slight changes found in their levels, as well.
Results showed that 98 patients were smokers, 72 were secondhand smokers,
and 306 were nonsmokers.

“For the first time, the entire smoking cessation story can be quickly
and noninvasively played out from beginning to end-detection, revealing the
effect, and intervention, all while being respectful of available
resources,” said Dr. Reddy. “Using this device, we can deliver the whole
package, and based on our data, we believe it should be routinely used in
any program geared toward smoking cessation.”

Researchers conclude that pulse cooximetery is a quick, inexpensive,
and noninvasive way to detect patients’ smoking status, and that the
outpatient clinic is an ideal setting for its use. They also suggest its
use for screening smoking status in multiple settings and populations, such
as smoking cessation programs, high schools, hospitals, and the workplace.

“Physicians need to be able to identify a patient’s smoking status in
order to effectively counsel them about smoking cessation,” said Alvin V.
Thomas, Jr., MD, FCCP, President of the American College of Chest
Physicians. “A method or device that could help physicians do this, and
potentially reduce the number of people who smoke, is a method that is
worth further exploration.”

CHEST 2007 is the 73rd annual international scientific assembly of the
American College of Chest Physicians, held October 20-25 in Chicago, IL.
ACCP represents 17,000 members who provide patient care in the areas of
pulmonary, critical care, and sleep medicine in the United States and
throughout the world. The ACCP’s mission is to promote the prevention and
treatment of diseases of the chest through leadership, education, research,
and communication. For more information about the ACCP, please visit the
ACCP Web site at chestnet.

American College of Chest Physicians
chestnet

The NHS will today pledge to become one of England’s leading sustainable and low carbon organisations and to meet the Government’s target of an 80 per cent reduction in carbon emissions by 2050.

This pledge is set out in a new Strategy, Saving Carbon, Improving Health, which will be launched by NHS Chief Executive, David Nicholson, and NHS Sustainable Development Unit Director, Dr David Pencheon.

The NHS has a carbon footprint of 18 million tonnes of CO2 per year – 3.2 per cent of carbon emissions and 25 per cent of public sector emissions in England. As part of the Strategy, NHS organisations are committing to reducing their carbon footprint. It will be for each organisation to determine how it does so and set its own targets if need be using the guidance from the Strategy. The NHS has set itself an ambition of achieving a 10 per cent reduction in its 2007 carbon footprint by 2015. This will require the current level of growth of emissions to not only be curbed, but the trend to be reversed and absolute emissions reduced.

Speaking at the launch ceremony at St Thomas’ Hospital in London, David Nicholson will say:
“As the biggest public sector employer in the country, the NHS needs to lead by example. I want to encourage NHS staff to really get involved and do their bit to create a greener NHS.

“I want to thank our partners who have signed up to support us to become a leading low carbon organisation. It is by working hard both within NHS trusts and with our partners that we can make the biggest impact on our carbon footprint.”

Dr David Pencheon, Director of the NHS Sustainable Development Unit will say:
“The NHS is an internationally renowned health service, Europe’s largest employer and a leader in local communities across the country. By leading by example the NHS can help mitigate climate change and improve our health tomorrow, as well as today.

“Carbon reduction is something that needs to extend to every part of the organisation. Everyone who works for the NHS should be thinking about reducing their carbon footprint as part of their day job.” The strategy will ensure that the NHS will achieve an enormous cut in carbon emissions ensuring it is leading low carbon and sustainable organisation and meets the Climate Change Act requirements.

Notes

1. Key recommendations in the NHS Carbon Reduction Strategy call for NHS organisations to:

* Establish a Board approved Sustainable Development Management Plan

* Sign up to the Good Corporate Citizenship Assessment Model (see corporatecitizen.nhs)

* Monitor and report on carbon

* Actively promote carbon awareness at every level of the organisation. The strategy also provides guidance and actions on: energy and carbon management; procurement; travel and transport; water; waste; designing the built environment; organisational and workforce development; role of partnership and networks; and governance. To see all of the recommendations, download the strategy from sdu.nhs.

2. The audio from the launch will be broadcast live, through BT conferencing. To listen in, register at https://cossprereg.btci/prereg/key.process?key=PR9D6MWXC. Once you have registered, you will be provided with the information you need to join the conference, including dial-in numbers and passcodes.

3. Saving Carbon, Improving Health, the NHS Carbon Reduction Strategy will be available to download from the NHS SDU website (sdu.nhs) from 27 January.

4. The NHS Sustainable Development Unit (NHS SDU) was established on 1 April 2008, by the NHS in England under the auspices of the Office of the Strategic Health Authorities (OSHA). The NHS SDU develops organisations, people, tools, policy, and research to help the NHS in England fulfil its potential as a leading sustainable and low carbon organisation. It is led by Dr David Pencheon, Director NHS SDU, and is overseen by the 10 Strategic Health Authority Chief Executives. The unit is hosted by the Strategic Health Authority in the east of England and its Chief Executive, Sir Neil McKay and Regional Director of Public Health, Dr Paul Cosford.
sdu.nhs

Department of Health, UK

Sanofi Pasteur, the vaccines division of sanofi-aventis Group (EURONEXT: SAN and NYSE: SNY), announces it is ready to support public health efforts to respond to the emergence of the new A(H1N1) influenza strain following the decision made by the World Health Organization (WHO) to raise the pandemic alert level from Phase 5 to Phase 6, the highest level of alert in the WHO global influenza preparedness plan.

“By committing to develop and supply a vaccine against the new influenza A(H1N1) strain,
Sanofi Pasteur supports the fight against pandemic influenza led by the WHO, the Department of
Health and Human Services (HHS) and the Centers for Disease Control and Prevention (CDC) in the
United States, the European Institutions, the French Ministry of Health and other national and
international health authorities around the world”, said Wayne Pisano, President and CEO of
Sanofi Pasteur. “Sanofi Pasteur remains in continuous communication with these health authorities to
help develop a tailored response to local public health needs”.

As the world’s largest supplier of influenza vaccine, Sanofi Pasteur is currently implementing its internal pandemic preparedness plans to ensure its continued ability to fulfill its public health mission to produce the largest number of doses of vaccine in the shortest time frame to face the threat of pandemic influenza while maintaining the production of other life-saving vaccines.

The company received the new A(H1N1) seed virus from WHO International Reference Centers, and
has begun preparation of a working seed to be used for vaccine production. Sanofi Pasteur currently
estimates it will have the first bulk concentrate vaccine within four to six months. This vaccine would
help prevent the spread of the new influenza A (H1N1) virus strain. Its availability would be subject to
regulatory approval.

Sanofi Pasteur received an order from the U.S. Department of Health and Human Services (HHS) on
May 25, 2009 for the supply of an A(H1N1) influenza vaccine.

Sanofi Pasteur’s response to the emergence of a new A(H1N1) influenza strain is to maintain flexibility in its influenza vaccine production. The company will continue to manufacture its seasonal influenza vaccine for the 2009/2010 Northern Hemisphere influenza season as recommended by the WHO. Production of seasonal influenza is still a priority as seasonal influenza is a very serious illness causing 250,000 to 500,000 deaths per year.

Phase 6 is characterized by human-to-human spread of a pandemic influenza virus and community
level outbreaks in at least two WHO regions of the world. Designation of this phase indicates that a
global pandemic is under way, according to the WHO. However, Phase 6 is not an indication of the
severity of the influenza pandemic.

Sanofi Pasteur Influenza Vaccine Production

Sanofi Pasteur operates influenza vaccine production facilities in Swiftwater, Pennsylvania, United
States, and Val de Reuil, France. All Sanofi Pasteur influenza vaccine facilities have been designed
and built to be able to switch from seasonal influenza vaccine production to pandemic influenza vaccine production.

In Swiftwater, Sanofi Pasteur has two licensed influenza production facilities. On May 6, 2009, the FDA licensed Sanofi Pasteur’s new influenza vaccine manufacturing facility in Swiftwater. When operating at full capacity, the new facility will have a capacity of approximately 100 million doses of seasonal influenza vaccine per year. An existing facility in Swiftwater is capable of producing 50 million doses per year and currently is producing vaccine for the 2009/2010 season. In total, the company will have a capacity equivalent to approximately 150 million doses of trivalent seasonal influenza vaccine per year in the United States when both facilities are operating at full capacity. The A(H1N1) production can occur in both Swiftwater facilities.

In Val De Reuil, Sanofi Pasteur is currently producing the trivalent seasonal influenza vaccine for the
2009/2010 season, with the capacity of 120 million doses per year. Sanofi Pasteur’s production facility in Val De Reuil is also capable of producing the new A(H1N1) vaccine.

Sanofi Pasteur produces approximately 40 percent of the influenza vaccines distributed worldwide and
in the United States produced more than 45 percent of the influenza vaccines distributed for the
2008/2009 influenza season. The company also has developed the first and only U.S.-licensed avian
influenza vaccine for humans.

About Sanofi Aventis

Sanofi-aventis, a leading global pharmaceutical company, discovers, develops and distributes
therapeutic solutions to improve the lives of everyone. Sanofi-aventis is listed in Paris (EURONEXT:
SAN) and in New York (NYSE: SNY).

Sanofi Pasteur, the vaccines division of sanofi-aventis Group, provided more than 1.6 billion doses of
vaccine in 2008, making it possible to immunize more than 500 million people across the globe. A
world leader in the vaccine industry, Sanofi Pasteur offers the broadest range of vaccines protecting
against 20 infectious diseases. The company’s heritage, to create vaccines that protect life, dates back more than a century. Sanofi Pasteur is the largest company entirely dedicated to vaccines. Every day, the company invests more than EUR 1 million in research and development.

Forward Looking Statements

This press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts. These statements include financial projections and estimates and their underlying assumptions, statements regarding plans, objectives, intentions and expectations with respect to future events, operations, products and services, and statements regarding future performance. Forward-looking statements are generally identified by the words “expects,” “anticipates,” “believes,” “intends,” “estimates,” “plans” and similar expressions. Although sanofiaventis’ management believes that the expectations reflected in such forward-looking statements are reasonable,
investors are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of sanofi-aventis, that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include those discussed or identified in the public filings with the SEC and the AMF made by sanofi-aventis, including those listed under “Risk Factors”
Page 3 of 3 and “Cautionary Statement Regarding Forward-Looking Statements” in sanofi-aventis’ annual report on Form 20- F for the year ended December 31, 2008. Other than as required by applicable law, sanofi-aventis does not undertake any obligation to update or revise any forward-looking information or statements.

Source: Sanofi Pasteur

On December 1st, Medicare and Tricare payments to doctors were going to be cut by 23%, the US Senate unanimously voted postpone this by another month – a stop-gap measure that has been going on for some time. This latest reprieve, called the Physician Payment and Therapy Relief Act of 2010 will cost $1 billion. Outpatient providers who perform multiple services on the same day will be paid less in order to make up for the extra $1 billion cost.

Senate Finance Committee Chairman Max Baucus (D-Mont.) and Ranking Member Chuck Grassley (R-Iowa) reached an accord yesterday to make sure seniors and families of military personnel are ensured continued medical care from their doctors.

Baucus and Grassley said:
“Working together, we have set a path to ensure seniors and military families can continue to get quality health care. This agreement makes certain that seniors and military families can be confident they will be able to see a doctor and get the medicines they need. It is our hope the Senate will pass this package as soon as possible to give doctors, seniors and military families the care and the certainty they deserve.”
Baucus and Grassley said they will work together to find a year-long fix to the formula before the one-month extension reaches its end. They added that they are both confident they will reach an agreement within the time constraints.

A survey carried out by the American Medical Association revealed that 94% of the American public is seriously concerned about the ominous cut to physicians. Apparently, most Americans want this sorted out once and for all.

AMA (American Medical Association) President Cecil B. Wilson, M.D., said last week before the latest one-month extension:
“This cut could not come at a worse time, as we are now in Medicare’s physician enrollment session for next year. Physicians want to care for seniors, but they are making decisions now about their Medicare participation status while they face a 25 percent cut. There is already a 20 percent gap between Medicare payments and the increasing cost of caring for seniors, and a cut of this magnitude could be the tipping point for physicians making difficult decisions in order to keep their medical practice doors open.”

Sources: US Senate, AMA

Yale School of Medicine is hosting a two-day symposium Nov. 1-2 on diseases of the aorta, with a dedication to the late actor John Ritter, who died of an aortic dissection four years ago.

The “Summit on Acute Aortic Diseases: Lux et Veritas” will be held in Mary S. Harkness Auditorium at 333 Cedar Street. The organizer of the program is John Elefteriades, M.D., section chief of cardiothoracic surgery at Yale. The summit is open to the public. The cost is $695 for non-Yale employees and $200 for Yale employees.

The aorta is the largest artery in the body. It originates from the left ventricle of the heart, and brings oxygenated blood to all parts of the body. An aortic dissection, such as Ritter suffered, occurs when there is a tear in the wall of the aorta.

Ritter’s widow, actor Amy Yasbeck, will deliver a retrospective of his work at a dinner to be held Nov. 1 in the Presidents Room on the second floor of Woolsey Hall at the corner of Wall and College Streets. At the dinner, David Tilson, M.D., of St. Luke’s Roosevelt Hospital in New York will deliver the keynote lecture titled — “Aortic Diseases and Creativity: Is There a Link?” Tickets for the dinner are $50 and guests must pre-register.

The program also will include a keynote address by Denton Cooley, M.D., on “The Aorta and I: A Lifetime Relationship.” Cooley, of the Texas Heart Institute, performed the first human heart transplant on May 3, 1968.

Additional topics will include the genetics and other risk factors of aortic aneurysms; the difficulty of using imaging technologies to diagnose aortic disease; and the relationship between weight lifting and acute aortic dissection, among others.

###

The full program can be viewed at aorta.yale.edu/ under “News and Events.”

Source: Jacqueline Weaver

Yale University

In the United States over 80,000 people are on the kidney transplant waiting list, and thousands die each year waiting for transplants. For most dialysis patients, kidney transplantation increases their chances of survival.

In the last decade physicians and surgeons began using organs from donors who suffered cardiac death [donors after cardiac death (DCD)] as an alternative to organs transplanted after donor brain death (DBD). DBD kidneys are believed to be superior for successful transplant. In DBD transplants, the circulatory system is maintained until the organ is preserved. In contrast, with DCD organs, the shutdown of the circulatory system and the attendant loss of blood supply to the kidney may cause damage to the transplant organ.

In a study appearing in an upcoming issue of the Journal of the American Society of Nephrology, Maarten G. Snoeijs, MD (Maastricht University Medical Center, the Netherlands) and co-authors analyzed 2,575 Dutch transplant candidates to see how receiving a DCD kidney affected their overall chances of survival.

“Over the past decade, DCD has evolved into an important new source of donor kidneys,” Snoeijs explained. “However, in many countries the large donor pool of DCD kidneys has not been fully utilized.” That is because questions remain as to the benefits of DCD transplants. Are patients better off receiving a DCD kidney or waiting for a kidney donated after brain death?

Kidneys donated after brain death are “generally believed to be superior,” according to Snoeijs. However, of the 2,575 wait-listed patients in this study, 26 percent received a DBD kidney and 18 percent received a DCD organ, so more than half either died or remained on the waiting list.

When DCD kidneys were transplanted, the failure rate in the first few months was nearly twice as high as for DBD kidneys. However, patients who received DCD kidneys had a 56 percent higher chance of survival, compared to those who stayed on dialysis waiting for a DBD kidney.

“We think these results may have a large influence on DCD kidney transplantation, which may eventually lead to a substantial reduction of the waiting list and improved survival of patients with end-stage renal disease,” said Snoeijs.

The study adds to “the preponderance of evidence” in favor of using DCD organs, according to an accompanying editorial by Nicholas Shah, MD, and Anthony Langone, MD (Vanderbilt University School of Medicine, Nashville, TN). They conclude, “Transplant centers should maximally utilize DCD kidneys to optimize the quality of life and minimize mortality of their patients on the waiting list.”

Like other observational studies, the current study is limited by the possibility of selection bias. “Due to careful statistical corrections, however, we consider it unlikely that the effect of DCD kidney transplantation on survival has been overestimated because of patient selection bias,” according to Snoeijs.

Disclosures: Dr. Snoeijs was supported by a clinical research trainee grant from the Netherlands Organization for Health Research and Development. Development of the statistical methodology and analysis was supported by National Institutes of Health grant R01 DK-70869 to Douglas E. Schaubel. The authors of the study and editorial declare no conflicts of interest.

Study co-authors were Douglas E. Schaubel, PhD (University of Michigan), Ronald HenГ©, MD, PhD (University Medical Center Utrecht), Andries J. Hoitsma, MD, PhD (Radboud University Medical Center), Mirza M. Idu, MD, PhD (Academic Medical Center), Jan N. Ijzermans, MD, PhD (Erasmus University Medical Center), Rutger J. Ploeg, MD, PhD (University Medical Center Groningen), Jan Ringers, MD (Leiden University Medical Center), Maarten H Christiaans, MD, PhD, Wim A Buurman, MD, and L.W. Ernest van Heurn, MD (Maastricht University Medical Center).

The article, entitled “Kidneys from Donors after Cardiac Death Provide Survival Benefit” (doi 10.1681/ASN.2009121203) and accompanying editorial, “Renal Donation after Cardiac Death” (doi 10.1681/ASN.2010040415) will appear online at jasn.asnjournals/ on May 20, 2010.

The American Society of Nephrology (ASN) does not offer medical advice. All content in ASN publications is for informational purposes only, and is not intended to cover all possible uses, directions, precautions, drug interactions, or adverse effects. This content should not be used during a medical emergency or for the diagnosis or treatment of any medical condition. Please consult your doctor or other qualified health care provider if you have any questions about a medical condition, or before taking any drug, changing your diet or commencing or discontinuing any course of treatment. Do not ignore or delay obtaining professional medical advice because of information accessed through ASN. Call 911 or your doctor for all medical emergencies.

Founded in 1966, ASN is the world’s largest professional society devoted to the study of kidney disease. Comprised of 11,000 physicians and scientists, ASN continues to promote expert patient care, to advance medical research, and to educate the renal community. ASN also informs policymakers about issues of importance to kidney doctors and their patients. ASN funds research, and through its world-renowned meetings and first-class publications, disseminates information and educational tools that empower physicians.

Source: American Society of Nephrology (ASN)

As part of our Scientific Support activities, ECDC is involved with catalyzing public health research. Our aim is to identify “directed” research needs (i.e. question- and need-based research goals) and to coordinate the application of results between key stakeholders. To achieve these goals, ECDC must keep abreast with state-of-the-art research in infectious disease control and prevention and support the mapping and networking of the different EU and global initiatives.

Thus, the Scientific Advice Unit launched on February 12th, 2008, the first of a series of planned “ECDC Research Symposia” on different topics in infectious disease control and prevention, in the context of our mission and mandate in public health: to improve coordination and networking between researchers, funders, implementers, and policy makers.
In this meeting the topic of “New Tools for TB control” was discussed and follow-up actions for improved advocacy, coordination, and funding investments proposed. Participants included project coordinators from six projects funded under the FP6 and FP7 programmes of the European Commission, as well as WHO representatives, and key European and international stakeholders.

Please see the meeting agenda and participants list and full meeting report to be made available in the coming months.

Many thanks to all of the participants and as well to DG RTD and DG SANCO for their scientific inputs and close collaboration for the meeting organization.

ecdc.europa.eu

(UroToday) – We carried out a retrospective study of 78 patients (39 were on PD and 39 on HD) who had their first renal transplantation between January 1986 and December 2004.

The following patient parameters were noted: age, gender, cadaveric donors (D), mean period of dialysis, mean transplantation (TR) follow-up, mean duration of first hospital stay (FH), first infection, post-transplant diabetes mellitus, acute tubular necrosis (ATN), acute rejection and patient and graft actuarial survival.

Patients were split up into two groups depending on whether they had had PD or HD before transplantation. Patients who were grafted in the same period, in the same centre and who were matched for age and sex were split up into 2 groups depending on whether they had had PD or HD. Diabetics were excluded from this study.

Analytical methods – Comparisons between groups were made using Chi-square test for qualitative parameters and non-paired student’s t-test for continuous variable. Statistical significance was accepted for p less than 0.05. Comparisons between actuarial curves of patient and technique survival were made using Logrank test. All analyses used StatView logiciel

I. Helal, MD, as part of Beyond the Abstract on UroToday. This initiative offers a method of publishing for the professional urology community. Authors are given an opportunity to expand on the circumstances, limitations etc… of their research by referencing the published abstract.

Link to Full Abstract

UroToday – the only urology website with original content global urology key opinion leaders actively engaged in clinical practice.

To access the latest urology news releases from UroToday, go to:
www.urotoday

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Copyright © 2007 – UroToday
Reproduced for blog with permission of UroToday.
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Hard-to-match kidney transplant candidates who receive a treatment designed to make their bodies more accepting of incompatible organs are twice as likely to survive eight years after transplant surgery as those who stay on dialysis for years awaiting compatible organs, new Johns Hopkins research finds.

“The results of this study should be a game changer for health care decision makers, including insurance companies, Medicare and transplant centers,” says Robert A. Montgomery, M.D., D. Phil., a professor of surgery at the Johns Hopkins University School of Medicine and leader of the study appearing in the July 28 New England Journal of Medicine. “There’s a dramatic survival benefit, so people should take note.”

Apart from the scarcity of donor kidneys, the biggest barrier to kidney transplant right now is the percentage (nearly one in three) of patients on the waiting list whose immune systems make them likely to reject most kidneys available to them, says Montgomery.

Widespread use of a presurgery protocol developed at Johns Hopkins, which removes problematic antibodies from a patient’s blood prior to transplant, could lead to potentially 3,000 more kidney transplants from living donors each year, he says. The presurgery process cannot be used at this point with patients receiving cadaver organs because several days of treatment are needed before surgery can take place.

“We have this presurgery therapy that doubles a person’s survival rate,” says Montgomery, who is also director of Johns Hopkins’ Comprehensive Transplant Center. “If this were a cancer drug that doubled chances of survival, people would be lined up out the door to get it. It’s really extraordinary to go from 30 percent survival to 80 percent survival after eight years.”

Montgomery estimates that these hard-to-match transplant candidates number more than 20,000 in the United States. Their immune systems will reject most kidneys because of antibodies circulating in their blood that react to proteins known as human leukocyte antigens (HLA). These proteins are found on most cells and are used by the immune system to recognize what is foreign to the body.

In what are known as HLA-sensitized patients, the body has been exposed to foreign HLA in the past, either through pregnancy, blood transfusion or previous kidney transplant, and it immediately recognizes most donor organs as unfamiliar, causing rejection. Women make up a majority of these patients because of sensitization from pregnancy.

Montgomery’s new protocol removes the problem antibodies from the blood before the transplant takes place through plasmapheresis, a process that removes, filters and replaces a person’s plasma supply. Then, the patient receives low-dose intravenous immune globulin (IVIg), which aims to replace those problematic antibodies and prevent their return. This process, which conditions the body to accept the new organ, is performed every other day for several days before transplant and then for up to 10 days following the surgery. Thereafter, Montgomery says, the patient just needs the same anti-rejection medication as any other transplant patient. In the study, there were very few significant side effects from plasmapheresis.

Historically, highly HLA-sensitized patients have been very difficult to match with fewer than 7 percent receiving transplants each year compared to a dramatic 98 percent transplant rate among patients offered the Johns Hopkins’ plasmapheresis protocol.

Montgomery says the protocol, which he and his colleagues at Hopkins pioneered in 1998, essentially allows an incompatible kidney to function long term, and in the majority of patients, the harmful antibodies do not return. Some other hospitals have begun using it, as well, but Montgomery says many others were awaiting data indicating long-term benefit to patients.

“Now we have it, the first study to show long-term survival benefit from desensitization,” he says.

In the new research, Montgomery and colleagues transplanted 211 HLA-sensitized patients between February 1998 and December 2009 using plasmapheresis and IVIg before and after surgery. In order to develop a control group, the researchers, on the day each patient received his or her incompatible transplant, identified five patients on the kidney waiting list who most closely matched the characteristics of the person who got the new organ. The researchers then followed the progress of those transplant candidates, as well, whether they remained on dialysis or eventually got a compatible organ.

After the first year, each group of patients had about the same chance for survival (in the low 90 percentile range). After eight years, however, the treatment group had an 80.6 percent survival rate, while the dialysis group had a 30.5 percent chance of survival. The patients who waited on the list with the possibility of receiving a compatible kidney had a 49.1 percent chance of eight-year survival. Montgomery points out that the number of these patients who actually received a compatible transplant was very small because finding compatible organs for HLA-sensitized patients is so challenging.

In 2008, of the 82,000 patients on the waiting list in the United States, 16,520 received kidney transplants whereas 4,800 died waiting for one.

Acknowledging that desensitization makes kidney transplants more expensive, Montgomery says the cost savings when compared to remaining on dialysis are enormous. Meanwhile, the patient no longer has to endure the difficulties of dialysis, a blood-cleansing process that takes about five hours a day, three days a week, and which often makes the tasks of daily life from working to caring for children nearly impossible.

“This treatment increases survival, ensures a better lifestyle and saves the health care system money,” he says. “There aren’t many things like that.”

Montgomery says he expects his findings to significantly ease doubts about the ability of HLA-sensitized candidates to have successful transplants. In many parts of the country, he says, insurers who historically have not covered desensitization should now reconsider.

This research was funded by the National Institute of Diabetes and Digestive and Kidney Diseases and the Charles T. Bauer Foundation.

Source: Johns Hopkins Medicine