Tampa General Hospital Is First In Florida To Use New Organ Transplant System For Three Different Organs

Tampa General Hospital is the first in Florida to adopt and use special machines that allow donor hearts, lungs and livers to function outside a human body

Tampa, FL /PRNewswire/ - Tampa General Hospital is the first in Florida to adopt and use a sophisticated organ transplant system that is designed to increase the number of donated hearts, livers and lungs that can be used to save the lives of patients.

The first lung transplant in Florida using this system was performed at Tampa General Hospital on October 22, 2019. The new Organ Care System (OCS™) technology allows a donated heart to keep beating for several hours outside a human body as it is transported to the hospital. This process, called normal temperature perfusion, keeps organs functioning almost as if they were still inside human bodies. During this process, hearts beat, livers produce bile and lungs breathe, all inside portable machines.

"We can maintain the organs for longer periods, which means we can retrieve them from a wider geographic area," said Dr. John Dunning, surgical director for Heart and Lung Transplantation at Tampa General Hospital and a professor of Cardiothoracic Surgery at the USF Health Morsani College of Medicine. "And, the condition of the organs at the time of transplant is better," compared to traditional methods.

Tampa General Hospital is the only hospital in Florida and among a handful in the United States to be using or formally studying the process for all three of these organs using the Organ Care System technology. TGH is one of the busiest transplant centers in the nation, having performed more than 10,000 transplant operations. The OCS machines are manufactured by TransMedics, Inc., of Massachusetts.

"At TGH, we use technology and innovation to meet the needs of our community," said Dr. Kiran Dhanireddy, executive director of the TGH Advanced Organ Disease and Transplantation Institute. "OCS allows us to expand the organ pool by having access to a wider geography of donors, which allows us to save more lives through transplantation."

The normal temperature perfusion process has already been approved by the FDA for use in lung transplant patients. TGH has conducted five liver perfusion transplants as part of a clinical trial.

"We are continually innovating to provide our patients with optimum care, and cutting-edge technology such as the OCS machine allows us to do that," said Dr. Amy Lu, a transplant surgeon who is the principal investigator on the TGH clinical trial.

At times, organs are transported to Tampa General from other cities. The traditional method is to use medical coolers for these journeys, which can sometimes take hours. The organs do not perform their normal functions while being transported in cold storage, but their health is preserved for several hours.

The OCS uses a different approach—transporting organs at near body temperature.

In OCS machines, blood, oxygen and nutrients constantly flow through the organs, just as they would inside a human body. So instead of merely being preserved, the organs continue functioning inside the machines. The flow of blood through the heart prompts it to continue beating. The liver produces bile – one of its essential activities. A ventilator puffs air into the lungs. A computer tablet-like device allows surgeons to monitor the health of the organs en route to the hospital.

Organs can survive longer in OCS machines than in traditional coolers. All organs must have blood flowing through them in order to continue as living, functioning organs. While a heart can survive in a medical cooler without a blood supply for roughly four hours, muscle cells will start to die as time goes on. But in the OCS, the heart still pumps and receives blood, so cells can survive longer.

The process has been shown to reduce the number and severity of rejection episodes in lung transplants, and organs in some cases actually get healthier after being placed in the OCS machines. For example, a potential donor who is on a ventilator in a hospital might develop fluid in their lungs as a side effect. But this can clear up when the lung is placed in the OCS. This improvement means more organs are likely to become medically suitable for transplantation. "We can actually monitor their function on the machine and see their function improving prior to transplantation," Dunning said.

The new technology increases organs available for donation. Currently, lungs are transplanted from patients who have become brain dead. But the OCS also allows transplants from patients whose deaths are classified as cardiac death, which has the potential to expand the donor pool by about 25 to 30 percent.

TGH's overall goal is not only to provide more life-saving transplants to meet the needs of our community by expanding the available donors, but also to continue to deliver the highest quality of care.

Tampa General has now performed more than 10,000 transplant operations, placing it among the top 10 busiest transplant centers in the nation. Numerous studies have shown that patients do better when they undergo surgeries in large surgical centers where the teams perform complex procedures more often.

Organ Care System (OCS™) Fact Sheet
Heart, liver and lung transplants:
Lungs
People who need transplants include those with emphysema, cystic fibrosis, interstitial lung disease or other severe conditions. Traditionally, lungs come from deceased donors who have suffered brain death. The OCS also allows the use of lungs from those who have suffered cardiac death.

In the OCS machine, air is ventilated into the lungs while they are being transported, allowing them to "breathe" almost as if they are inside a body.

The FDA has approved the use of the OCS for lung transplants. And Tampa General Hospital performed the first such lung transplant in Florida on Oct. 22.

Livers
People who need transplants include those with diseases that prevent the liver from performing its essential body functions. Livers come from deceased donors who have suffered brain death or cardiac death. Partial liver transplants sometimes come from living donors.

In the OCS machine, blood, oxygen and nutrients flow through the donated liver and it produces bile, one of its essential functions, almost as if it is inside a body.

Tampa General Hospital is participating in a multicenter national clinical trial to evaluate efficacy of the OCS for liver transplantation. After the conclusion of the study, the results will be used to obtain FDA approval for clinical use.

Hearts
People who need transplants include those who have advanced heart diseases but are healthy enough to be well with a transplanted heart.

Currently, hearts come from deceased donors who have suffered brain death. The OCS is being used to explore the potential for using hearts from patients who have died a cardiac death.

In the OCS machine, blood is sent into the heart, which prompts the heart tissue to activate electrical impulses and begin beating.

Tampa General Hospital will participate in a clinical trial on the use of OCS for heart transplantation.

ABOUT TAMPA GENERAL HOSPITAL
Tampa General Hospital, a 1007-bed non-profit academic medical center, delivers world-class care as the region's only center for Level l trauma and comprehensive burn care. It is one of the nation's busiest adult solid organ transplant centers and is the primary teaching hospital for the USF Health Morsani College of Medicine. With five medical helicopters, Tampa General Hospital transports critically injured or ill patients from 23 surrounding counties to receive the advanced care they need. Tampa General houses a nationally accredited comprehensive stroke center and its 32-bed Neuroscience Intensive Care Unit is the largest on the West Coast of Florida. It also is home to an 82-bed Level IV neonatal intensive care unit, and a nationally accredited rehabilitation center. Tampa General Hospital's footprint includes 14 Tampa General Medical Group Primary Care offices, TGH Family Care Center Kennedy, TGH Brandon Healthplex, TGH Virtual Care and 15 outpatient Radiology Centers. Tampa Bay residents also receive world-class care from the TGH Urgent Care powered by Fast Track network of clinics, and they can even receive home visits in select areas through TGH Urgent Care at Home, powered by Fast Track. As one of the largest hospitals in Florida, Tampa General Hospital is first in the state to open a command center in partnership with GE Healthcare. For more information, go to www.tgh.org.

ABOUT TRANSMEDICS
TransMedics was founded to address the growing need for healthier organs for transplantation. We are focused on transforming the standard of care – increasing organ utilization, improving patient outcomes, and reducing transplant costs.
The Organ Care System (OCS™) platform is a revolutionary technology for preserving organs used in the treatment of end-stage heart, lung, and liver failure.The OCS is the first and only multi-organ platform to leverage proprietary core technologies across multiple organs.The OCS Lung, OCS Heart and OCS Liver are all CE marked devices.
The OCS Lung is an FDA-approved device for standard and expanded criteria donor lungs.
The OCS Heart and OCS Liver devices are investigational devices and, therefore, are limited by federal law to investigational use in the US.OCS is the only technology that can be utilized with multiple organs.