Increasing Survival Of Organ Tx Patients By Reducing Time Interval For Transported Organs

[Guest guest]

Source:

International

Society for Heart and Lung Transplantation

Date:

April 30, 2007

Increasing

Survival Of Organ Transplant Patients By Reducing Time

Interval For Transported Organs

Science Daily — Preservation

of an organ intended for transplant during transport from donor to recipient is

of primary concern in ensuring a successful transplant. Research

presented at the ISHLT 27th Annual Meeting and Scientific Sessions today

explores two diverging systems for pump preservation -- the Organ Care System

(OCS) and the cold preservation method, and how they each effect survival for

heart transplant patients.

The cold

preservation method, which has been in practice for more than 25 years,

delivers the organ in a non-functioning state immersed in a cold solution for

preservation during transport. The time during

transport in this method is referred to as cold ischemic time (CIT), more

specifically the interval beginning when an organ is removed from the donor and

is cooled with the solution, to the time when the organ is implanted.

Conversely,

the Organ Care System (OCS) is based on warm blood perfusion technology, which

it uses to maintain organs in a warm, functioning state. This

state mimics the environment of the human body during transport from organ

donor to recipient. Nutrient rich, oxygenated blood is

continuously pumped through the heart in order to maintain the organ in a

living, beating, state. Preserving an organ with this

method reduces CIT and allows for evaluation of organ function during

transport.

New data

presented during a late afternoon session on Wednesday, Concurrent Session 2

Cardiac Ischemic Time: Warm, Cold, or Pump?, highlighted the benefits of

reducing or eliminating CIT, such as increased availability of donor organs,

improved transplant outcomes, and reduced costs associated with end stage organ

failure. Presentations during the session outlined

research results demonstrating that reducing CIT will increase survivorship,

and further how the OCS may eliminate CIT almost entirely.

Gero Tenderich,

M.D., Clinic for Thoracic and Cardiovascular Medicine, Bad Oeynhausen,

Germany, provided results from the PROTECT I clinical trial, Prospective

Multi-Center European Trial To Evaluate the Safety and Performance of the Organ

Care System for Heart Transplants, during the Wednesday session (Abstract 10). The PROTECT I trial, which was performed in Europe,

studied the efficacy of the OCS in regards to survivorship.

The

results demonstrate the use of the OCS in maintaining and transporting donated

hearts for transplant surgery. Results showed 100

percent survival of patients 30 days post surgery. Results

also revealed that using the OCS allowed for patients to spend less time on the

ventilator and experience a quicker recovery in the hospital.

The ability of the OCS to assess organ function was also discussed. The trial sites participating in the PROTECT I study

included the Clinic for Thoracic and Cardiovascular Medicine, Bad Oeynhausen and the German Heart Institute in Berlin,

Germany, as well as Papworth Hospital and Harefield Hospitals, NHS Trusts in Cambridge and Middlesex,

United Kingdom, respectively.

The U.S.

Food and Drug Administration has recently granted IDE approval to initiate the

pilot phase of the PROCEED multi-center clinical trial in the U.S.

to evaluate the safety and performance of the OCS for heart transplants. The PROCEED trials will take place at five centers,

including University of Pittsburgh Medical Center in Pittsburgh; Heart, Lung,

and Esophageal Surgery Institute in Pittsburgh; UCLA Medical Center in Los

Angeles; The Cleveland Clinic Heart and Vascular Institute in Cleveland, The

University of Chicago Hospitals Cardiac Center in Chicago and Brigham &

Women's Hospital in Boston.

" The

PROTECT trial results establish validity of the Organ Care System. Given its relatively recent introduction to the transplant

world, we are excited about the results and look forward to seeing what further

tests will demonstrate about this innovative system, " said Bruce Rosengard, M.D., Director of Cardiac Transplantation at

Massachusetts General Hospital and former ISHLT board member.

Analysis

of data from studies conducted in the United

Kingdom and Australia

were presented by n Gooi, M.D., Alfred

Hospital, Melbourne,

Australia, The Potential

Impact of Reducing Cold Ischaemic Time on Cardiac

Transplant Survival (Abstract 8) during the same Concurrent Session. The analysis concluded that a CIT of less than one hour

would result in longer-term survival or an increase in life-years gained (LYG). Overall, the research showed that there were 2.2 LYG per

donor heart for the United Kingdom

transplant program, and 2.1 LYG per donor heart for the Australian transplant

program. Dr. Gooi's

presentation demonstrated how reworking the means of transport and developing

central procurement and transplant centers could be beneficial to the

transplant community.

" These

results should alert the transplant community of issues that need immediate

attention in order to increase survivorship in transplant patients. The amount of life years gained through better efficiency

within the organ transport system is astonishing, " continued Dr. Rosengard.

The

PROTECT I trials were sponsored by TransMedics (Andover,

MA).

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