Thursday, February 3, 2011

Liver Transplant Updates and Information


I was a failure as a parent, I didn't offer up a plush organ for Christmas. Who knew? Instead my children received legos, teddy bears, PLAY-DOH, cookie monster and everything nintendo.
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This parent had unrealistic expectations for all my children, from the day of conception I had visions of little doctors and lawyers and such. Well, maybe not a lawyer.

If I knew then, what I know now, each of my children would have been registered in an organ of the month club.

Starting with my favorite organ
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The liver makes many of the body’s most vital chemicals, including cholesterol, bile, proteins and the clotting factors needed to stop bleeding. It also stores sugars, proteins, vitamins for use later. The liver also helps break down harmful substances and metabolize drugs. He works in detox! Say liver in Japanese: Kanzou!
Some parents; ME. May assume these plush organs could serve as an inspiration to children; MINE, for a career in medicine. Although, its highly unlikely that my kids would have felt inspired. They would have either put "little yellow liver" in the microwave or gave it to the dog next door.
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These little stuffed organs are strange, or are they?

Maybe these toys could bring a smile to a child or adult as they recover from surgery, in particular liver transplant surgery. As I looked at these fluffy little critters, I began to think of the friends I met online, or in person, who needed a transplant. Although, I knew many more who needed one, then received one.

As of today, on this cold winter morning , according to(OPTN) there are 110,233 candidates who are waiting for a transplant.
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What's the number of candidates waiting for a liver in the US ?
16,066

Hepatitis C is the leading indication for liver transplantation, with HCV diagnosed in about half of the patients who receive liver transplants each year in the United States.

Best Hospitals For Liver Transplantation

On (November 17, 2010) – HealthGrades made available to organ transplant patients a list of those hospitals with the best track record for survival and chances of receiving a donor organ. This information is available, free to the public, at HealthGrades.com and is intended to help patients in need of kidney, lung, heart or liver transplants.

HealthGrades Liver Transplant Excellence Award recognized 4 recipients out of 95 hospitals evaluated:


The ratings of individual hospitals, as well as the full methodology of the analysis, can be found at http://www.healthgrades.com/.

Finding Support
Two great places for online support are here and here; or most certainly at a local transplant center. At one of these support groups you can connect face to face. For me, I loved my friends online. They soon became my saving grace, I will never forget the friends that kept me sane, as I quickly felt my world would forever change; when I heard those words " You have Hepatitis C".
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If you’ve received an organ transplant or are in need of an organ transplant, there are organ transplantation support groups available to you and your family to help deal with the organ transplantation waiting process, preparation for the organ transplant, and adjusting to the new lifestyle after your organ transplant.

The status.com theStatus.com is a free web-based service. Patients and families can use the website to create a private, secure and confidential place to share information about a patient’s care and condition.

The Transplant Process

The process starts with the physician or specialist who will be providing your care. If it is determined you need a transplant you will be referred to a transplant center. With the referral in hand the appointment for an evaluation begins.


What is the workup process like?

There are many different tests and consults that will be performed to determine if you are a suitable candidate for liver transplantation. Below is a list of some of the tests that will be ordered as part of your evaluation. Other tests or consults may be ordered based on the results of these tests.

Blood/Urine/Stool tests - Blood tests and specimen collection to help assess your overall physical condition.

Colonoscopy – A procedure to screen your colon.
Endoscopy- A procedure to screen your upper gastrointestinal tract.
Chest X-ray - The test assesses the size of your heart and any lung abnormalities
MRI or CT Scan of Abdomen - Examines the kidneys, liver, and gallbladder for the presence of cysts, stones, lesions, portal vein patency, ascites, and or other abnormalities.
TB Skin testing - A small amount of solution is injected under the skin on your forearm to determine if you have been exposed to tuberculosis.
Gynecological exam – All women will need a gynecological exam within the last year. Mammograms are also required for all women over age 40.
Pulmonary function studies - If you have a history of lung disease or tobacco use, your transplant work-up may include pulmonary (lung) function studies.
Cardiac tests – These tests will assess your heart function and will include an echocardiogram, and electrocardiogram (EKG or ECG). A stress test and a cardiac catheterization are done if indicated.

Physical examination (gives the doctor an overall picture of the patient’s condition).
Everyone is different; therefore, every evaluation will be tailored to evaluate specific patient’s needs.

Medical Review Board:

When your evaluation is complete, your case will be presented to the Medical Review Board (the MRB). The MRB consists of a multidisciplinary team of hepatologists, transplant surgeons, transplant coordinators, a dietician, social workers, financial counselor and consulting physicians. The purpose of the MRB is to discuss each evaluant case by case and to determine possible candidacy. Recommendations may be made by the MRB prior to making a final decision for transplant eligibility. All evaluants will be notified via certified mail and contacted by their assigned coordinator of the MRB outcomes and recommendations.


Why would I not be eligible for a liver transplant at SLEH?

Significant or advanced cardiac, pulmonary, nervous system or other systemic diseases, except where dual organ transplants are being considered (i.e. liver/lung. liver/kidney, liver/heart)
Systemic infection
Hepatocellular carincoma with extrahepatic (outside the liver) spread or vascular involvement
Presence of malignancies outside the liver with the exception of special cases such as neuroendocrine tumors

Acute severe hemodynamic compromise at the time of transplantation if accompanied by compromise or failure of one or more vital organs. Severe compromise is defined by the requirement of inotropic agents to maintain systolic blood pressure >90 mm Hg or pulmonary hypertension with a mean of >33 mm Hg
Active alcohol or drug abuse
History of behavior pattern or psychiatric illness considered likely to interfere significantly with compliance
Lack of sufficient social support to allow 24 hour care
Portal vein thrombosis
Patients with uncontrolled severe comorbid medical conditions
Obesity (BMI >40), which may result in technical or medical complications in the peri-operative and post operative periods


Is There A Waiting Period for Transplant?

If you are accepted for transplantation, you will be placed on a national computer list of active candidates waiting for a donor. Recipients are chosen according to a complex set of criteria, including MELD Score (Model for End Stage Liver Disease) blood type, and length of time on the waiting list. Recipients are chosen primarily on the basis of medical urgency within each ABO blood group. Waiting time is only a factor when patients have the same MELD score.


The United Network for Organ Sharing (UNOS) coordinates the equitable sharing of organs throughout the United States and oversees all donor centers and procurement agencies. MELD SCORE - is a numerical scale used for adult liver transplant candidates. The range is from 6 (less ill) to 40 (gravely ill). The individual score determines how urgently a patient needs a liver transplant. The number is calculated using your most recent laboratory tests. For additional information please log on to http://www.unos.org/ .

Lab values used in the MELD calculation:

Bilirubin, which measures how effectively the liver excretes bile;
INR (formally known as the prothrombin time), measures the liver’s ability to make blood clotting factors;
Creatinine, which measures kidney function. Impaired kidney function is often associated with severe liver disease.
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Patient Services
UNOS’ Patient Services Department provides transplantation and donation information to patients, family members, friends, potential donors and medical professionals. Information can be requested on topics such as:
The transplantation and donation process
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Living donation
Various national, regional, state and center-specific data reports
Many other helpful resources are available:
Transplant Living >
No matter where you are in the transplant experience, Transplant Living can help you be prepared with helpful information, resources and tools.
Patient Brochures >
Find free information designed to help patients understand the organ transplant process. You can also request custom patient information packets here.
Fact Sheets >
Review and print summary presentations of various topics relating to transplantation.

Check out the waiting list at your hospitial.

At the website (OPTN) =Organ Procurement and Transplantation Nework, the site offers a datasource listing each state in the U.S. where a patient can choose a hospitial and read a detailed profile of the current "Liver Waiting List" from the chosen center. This datasource allows the candidate to search according to; State, Age, Blood Type, Ethnicity, and Gender

Included is "Waiting List Data;

The candidate can choose to search for either or both A and B profiles.
Candidates need to pick either ; Registration or Candidate

Waiting List Data
A. Profile of current Liver Waiting List with recent additions and removals

Registrations - A patient who is waiting at more than one center, or for multiple organs, has multiple registrations.
Candidates - A patient who is waiting at more than one center, or for multiple organs, is considered as one candidate.
B. Profile of Percent Transplanted Liver Waiting List Registrations (Regional Data only)
In the "Transplant Data" section the candiate can search for any of the following;

C. Profile of Liver Transplants
D. Liver Transplants by Transplant Center within OPO service area
E. Profile of Graft Survival Rates for Liver Transplants (Regional Data only)
F. Profile of Patient Survival Rates for Liver Transplants (Regional Data only)
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Donor Data
G. Profile of Deceased and Living Liver Donors by OPO service area.
After entering your search criteria up pops the report.
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For a report start your search here and click on the map.
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Noted at the site; To find risk-adjusted, transplant-related statistics for specific transplant centers, please see the Scientific Registry of Transplant Recipients (SRTR) [Exit Disclaimer] Web site. The SRTR site contains data that enables patients to measure the performance of various transplant centers. The SRTR Web site is produced and maintained by the Chronic Disease Research Group of the Minneapolis Medical Research Foundation that holds the Scientific Registry of Transplant Recipients contract.


Hepatitis C Treatment and Liver Transplantation

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In The News
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Advances in Chronic Hepatitis C Treatment And Liver Transplantation: An Update
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Jan 2011

The Center for the Study of Hepatitis C (CSHC) at NewYork-Presbyterian/Weill Cornell Medical Center is engaged in diverse HCV investigations.
One of us (Dr. Talal) has undertaken research on viral kinetics, presenting the first evaluation of pegIFN pharmacokinetics in patients coinfected with HCV and HIV, finding that, although pharmacokinetic parameters do not differentiate sustained virological responders from nonresponders, certain pharmaco - dynamic measurements do and might therefore serve as useful predictors of treatment outcome.
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Free registration is required, I know ! Hate that.

By registering on our website, you will have access to all of McMahon Publishing's websites. Registration is free. Just fill in the form below and you're done!
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Download to read this article in PDF document:
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First liver transplant patients receive experimental drug to prevent hepatitis C infection

January 18, 2011 -->
"In nearly all cases, the patient's new liver is eventually infected by HCV because the virus remains in the patient's bloodstream during surgery. The course of recurrent HCV disease is accelerated after transplantation and up to 20 percent of transplant patients develop cirrhosis within five years. Unfortunately, the standard antiviral drugs currently used to treat HCV prior to the onset of end-stage liver disease are poorly tolerated after liver transplantation, leaving these patients"
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The first patients were enrolled in the study in December. The primary goal of this randomized, double-blind, placebo-controlled study is to test if the monoclonal antibody, designated MBL-HCV1, prevents re-infection of patients chronically infected with HCV who are undergoing .
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MassBiologics plans to enroll 16 patients in the first part of the study. "We are hopeful that positive results from this study will meet an important public health need, and we could not take this important step without the willing and thoughtful participation of these volunteers," said Donna Ambrosino, MD, executive director of MassBiologics and a professor of pediatrics at the Medical School.

There are currently five hospitals participating in the trial—Massachusetts General Hospital, Beth Israel Deaconess Medical Center, both in Boston, Lahey Clinic in Burlington, Massachusetts, Yale-New Haven Hospital in Connecticut and Mount Sinai Hospital in New York City—and others may join in the coming months. The first six patients enrolled have come from three of these sites.
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HCV damages the liver and is the leading indication for liver transplantation, diagnosed in about half of the 6,000 patients who receive liver transplants each year in the United States. According to the US Centers for Disease Control and Prevention, 3.2 million Americans are chronically infected with HCV and approximately 10,000 die annually of the disease. Globally, as many as 170 million people are estimated to suffer from HCV infection.
For patients with end-stage liver disease from HCV infection, liver transplantation is the only option. While it can be a life-saving treatment, transplantation does not cure the disease. In nearly all cases, the patient's new liver is eventually infected by HCV because the virus remains in the patient's bloodstream during surgery. The course of recurrent HCV disease is accelerated after transplantation and up to 20 percent of transplant patients develop cirrhosis within five years. Unfortunately, the standard antiviral drugs currently used to treat HCV prior to the onset of end-stage liver disease are poorly tolerated after liver transplantation, leaving these patients


To address this unmet medical need, the team at MassBiologics, working in collaboration with investigators Gyongyi Szabo, MD, PhD, professor of medicine, and Robert Finberg, MD, professor and chair of the Department of Medicine at UMMS, set out to develop a human monoclonal antibody that could clear HCV from a patient's bloodstream and protect the donated liver from infection. In pre-clinical studies, MBL-HCV1 successfully neutralized the virus in cell culture and animal models of infection. A Phase 1 study in 31 healthy volunteers completed in 2009 showed the antibody was well tolerated, with no serious side effects. The Phase 1 study also measured the levels of the antibody in the bloodstream and its ability to bind and inactivate the virus, thereby helping to establish the dosage and protocol for the Phase 2 study now under way.

In the current study, patients will be randomized to receive an infusion of either the antibody or placebo between one and four hours prior to surgery. Then, during the phase of surgery when the diseased liver is removed, but before the is implanted, patients will receive a second infusion of either the antibody or placebo. After the surgery is completed, the patients will receive a third infusion, and then daily infusions during the first week of recovery. A final infusion is administered on the 14th day after liver transplantation.

"The liver is the main reservoir for the ," said Brett Leav, MD, senior director of clinical affairs at MassBiologics. "The virus circulates in the blood, but only resides and replicates in the liver. So the idea here is to clear the virus from the bloodstream before it has an opportunity to re-infect the new liver."

After transplantation, patients' blood will be tested on a regular basis to screen for reemergence of HCV, which is usually detected within the first week after transplantation. The primary goal of the Phase 2 trial is to see if the patients who received the antibody are free of HCV at 42 days after transplantation. An interim analysis is planned after the first 16 patients have been enrolled in the trial, and a Data Safety and Monitoring Board overseeing the study will assess the effectiveness and safety of MBL-HCV1.



Vertex and Tibotec also plan to conduct several additional clinical trials of telaprevir in 2011 that aim to expand the future patient population for telaprevir-based regimens.

Phase 2 Post-Transplant Study: Vertex recently completed a drug-drug interaction study of telaprevir with immunosuppressive agents commonly used following a liver transplant. Based on results from this study, Vertex and Tibotec plan to initiate in 2011 a Phase 2 study of telaprevir-based regimens in people with recurrent hepatitis C following a liver transplant.


On This Blog; 2011





2010








Transplant Journals;


Evaluation of the Patient for Liver Transplantation
June 2005; Last reviewed 2008 September
Scheduled Update ; 2011
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Upcoming Meeting
December 16-17, 2011, Lisbon, Portugal



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