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:
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.
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.
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 HOSPITALTampa 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 TRANSMEDICSTransMedics 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.
Media Contact: Curtis KruegerSenior Public Relations Editor(o) (813) 844-7322(c) (727) 580-1813 firstname.lastname@example.org
SOURCE Florida Health Sciences Center, Inc. d/b/a Tampa General Hospital
第一个在弗洛里达州使用该系统的肺移植于2019年10月22日在坦帕总医院进行。新的器官护理系统（ OCS ™）技术允许捐赠的心脏在运送到医院时在人体外持续跳动数小时。这个过程被称为正常的温度灌注，保持器官的功能几乎就像它们仍然在人体内一样。在这个过程中，心脏跳动，肝脏产生胆汁和肺部呼吸，所有在便携式机器内部。
坦帕综合医院心肺移植外科主任、美国联邦健康基金会 Morsani 医学院心胸外科教授 John Dunning 博士说：“我们可以维持更长时间的器官，这意味着我们可以从更广阔的地理区域中提取器官。”与传统方法相比，移植时的器官状况更好。
坦帕综合医院是弗洛里达州唯一的医院，在美国少数正在使用或正式研究这三个器官使用器官护理系统技术的过程中。TGH 是美国最繁忙的移植中心之一，完成了1万多项移植手术。OCS 机器是由马萨诸塞州的 TransMedics 公司制造的。
“在 TGH ，我们利用技术和创新来满足我们社区的需求，” TGH 高级器官疾病和移植研究所执行主任 KiranDhannireddy 博士说。“ OCS 允许我们通过接触更广泛的捐献者的地理位置来扩大器官池，这使我们能够通过移植挽救更多的生命。”
正常的温度灌注过程已经被 FDA 批准用于肺移植患者。作为临床试验的一部分， TGH 进行了五次肝脏灌注移植。
“我们不断创新，为病人提供最佳的护理，和尖端技术，如 OCS 机器允许我们这样做，” AmyLu 博士说，一个移植外科医生，谁是 TGH 临床试验的主要研究者。
在 OCS 机器中，血液、氧气和营养物质不断地流经器官，就像它们在人体内一样。因此，这些器官不是仅仅被保存下来，而是继续在机器内部运作。血液通过心脏的流动促使它继续跳动。肝脏产生胆汁——胆汁的主要活动之一.呼吸机把空气吹进肺部.一种类似电脑平板电脑的设备可以让外科医生监测通往医院的器官的健康状况。
与传统的冷却器相比,在 OCS 机器中,器官可以存活更长时间.所有器官都必须有血液流经它们,以便作为活的、有功能的器官继续存在.虽然心脏可以在没有血液供应的情况下生存四个小时，肌肉细胞将随着时间的推移而开始死亡。但是在 OCS 中，心脏仍然泵血和接受血液，所以细胞可以存活更长时间。
这一过程已被证明可以减少肺移植中排斥反应的数量和严重程度，在某些情况下，器官被放置在 OCS 机器后实际上变得更加健康。例如，医院呼吸机的潜在供者可能会在肺部产生液体作为副作用。但是当肺部被放置在 OCS 中时，这就可以清除。这种改善意味着更多的器官可能在医学上适合移植。“我们可以实际监测他们的功能在机器上，并看到他们的功能改善之前移植，”邓宁说。
新技术增加了可供捐赠的器官。目前,肺是从脑死亡患者中移植过来的.但是 OCS 也允许心脏死亡患者移植心脏，这有可能使供血池扩大25%到30%。
器官护理系统（ OCS ™）情况说明
在 OCS 机器中，空气在运输过程中被排入肺部，让它们“呼吸”几乎就像在体内一样。
FDA 已经批准将 OCS 用于肺移植。10月22日，坦帕总医院在弗洛里达州进行了首次此类肺移植。
在 OCS 机器中，血液、氧气和营养物质流经捐赠的肝脏并产生胆汁，胆汁是其基本功能之一，就像它在体内一样。
坦帕总医院正在参与多中心国家临床试验，以评估 OCS 对肝移植的疗效。研究结束后，研究结果将用于获得 FDA 批准用于临床使用。
在 OCS 机器中，血液被送进心脏，提示心脏组织激活电脉冲并开始跳动。
坦帕总医院将参与使用 OCS 进行心脏移植的临床试验。
拥有1007张床位的非营利性学术医疗中心 TAMPA 综合医院是该地区唯一的一级创伤和综合烧伤治疗中心。它是美国最繁忙的成人固体器官移植中心之一，是美国南加州大学健康森尼医学院的主要教学医院。坦帕总医院有五架医疗直升机，运送来自23个县的重伤或病员接受他们所需的高级护理。坦帕将军拥有一个全国认可的综合中风中心和它的32个床位的神经科学强化护理单位是最大的西海岸弗洛里达州。它还拥有一个82张床位的新生儿强化护理病房和一个国家认可的康复中心。坦帕综合医院的足迹包括14个坦帕综合医疗集团初级保健办事处， TGH 家庭保健中心肯尼迪， TGH Brandon Healthplex ， TGH 虚拟保健和15个门诊放射中心。坦帕湾居民也得到世界一流的护理 TGH 紧急护理由快速通道网络的诊所，他们甚至可以接受家庭访问选定地区通过 TGH 紧急护理在家里，由快速通道。作为弗洛里达州最大的医院之一，坦帕综合医院是美国第一家与通用 GE医疗（GE Healthcare）公司合作开设指挥中心的医院。有关详细信息，请访问:\160; www.tgh.org 。
由于 TRANSMEDICSTransMedics 的建立，以解决日益增长的需要更健康的器官移植。我们致力于改变护理标准——提高器官利用率，改善病人预后，降低移植成本。器官护理系统（ OCS ™）平台是一项革命性的技术，用于保存用于治疗终末期心脏、肺和肝脏衰竭的器官。OCS 是第一个也是唯一一个跨多器官利用专有核心技术的多器官平台。OCS 肺、 OCS 心、 OCS 肝均为 CE 标记装置。OCS 肺是 FDA 批准的标准和扩大标准供者肺的设备。OCS 心脏和 OCS 肝脏装置是研究装置，因此，受联邦法律限制，在美国调查使用。OCS 是目前唯一一种可以应用于多种器官的技术。
媒体联系人： Curtis Krueger 高级公共关系编辑( o )(813)844-7322( c )(727)580-1813 ckrueger @ tgh.org
弗洛里达州健康科学中心， d / b / a 坦帕总医院