Volume, Outcomes, and Cost of Patient Care
Have Potential for Improvement
Heart transplantation programs world-wide face a number of daunting challenges regarding transplant volume, patient outcomes, and cost of patient care.
Demand Exceeds Transplant Volume
Heart transplantation is widely considered the only long-term cure for end-stage heart failure. Demand for heart transplantation is strong and growing -- the waiting lists represent only a small fraction of the patients who would benefit from the procedure. However, transplant programs cannot meet patient demand, leaving many to die on the waiting list.
Outcomes Can Be Improved
Those patients fortunate enough to receive a heart transplant generally experience substantial survival and quality of life benefits. That said, the procedure is not without risks. Despite medical advances over the past two decades, post-transplant mortality and complication rates, particularly within the first year after transplant, remain significant. Over the next decade, aging donor and recipient populations and increasing waiting times will strain patient outcomes even further.
Delayed Treatment and Complications are Costly
The costs of managing and treating critically-ill patients awaiting heart transplantation and the costs of caring for patients recovering from post-transplant complications are staggering.
Cold Storage Method is Limiting
One of the factors contributing to these difficulties is the current method of heart preservation: cold storage.
Number of Retrievable Hearts is Constrained
Cold storage significantly limits the number of hearts that can be retrieved for a safe transplant. Despite the desperate need for organs, seven hearts from every ten organ donors go unutilized in part because of the inability of the cold storage approach to adequately preserve the organ or to assess the organ's suitability for transplantation:
- LVH: Hearts with left ventricular hypertrophy cannot adequately be preserved under cold storage and often go unutilized.
- Distance: Even with the use of jets and helicopters to accelerate transport, the heart retrieval range is still limited because cold storage cannot adequately preserve the organ for more than a few hours.
- Brain-Death Storm: The biochemical effects of the brain-death storm can mask the true functionality of a donated heart, and many potentially suitable hearts affected by this imbalance go unutilized.
Heart Quality and Function Can Deteriorate Undetected
Cold storage can allow quality & function of donated hearts to deteriorate undetected before they are transplanted into a Recipient.
- Cold Ischemia: The damaging effects of cold ischemia can become permanent during transport.
- Metabolic Inactivity: Because the current cold storage method maintains the donated heart in a state of suspended animation, the surgeon cannot assess the extent of degradation until after the heart is transplanted.
INVESTIGATIONAL DEVICE: Not commercially available in the U.S.