Case Study Report

Written by Kevin Riley, Senior Clinical Specialist, Paragonix Technologies, Inc.:

“The Ice Age is Over!”


A Donor Heart Procurement with the Paragonix SherpaPak™ Cardiac Transport System – with the Assurance and Record of Robust Temperature Control


This recent Case Study Report of the Paragonix SherpaPak™ Cardiac Transport System involved a long distance (over 1,100 miles) donor heart procurement. The Paragonix SherpaPak™ Cardiac Transport System demonstrated stable temperature maintenance during preservation and provided for excellent graft function post-implantation.


Recipient and Donor Background

The recipient patient was a male patient with a history of cardiomyopathy and heart failure requiring heart transplantation at a leading Boston teaching hospital. A female donor was identified in the Southern US. Infectious disease results indicated the donor was Hep C Ab+ positive; however, NAT testing was negative.


Method of Donor Heart Transport

The Paragonix SherpaPak™ Cardiac Transport System (CTS) was the chosen method for donor heart preservation and transport.


Transport Preparation

Prior to use, the Paragonix SherpaCool™ Ribbons and Pouch had been preconditioned in a -20°C freezer for 48 hours and prior to recovery team departure to the donor hospital. The Paragonix SherpaCool™ material was transported in an ice chest with four (4) liters of preservation solution.


Donor Heart Recovery

Prior to donor heart cross clamp, three (3) liters of cold preservation solution were decanted into the sterile Paragonix SherpaPak™ organ canister, which is designed to hold the heart. Prior to placement within the organ canister, the heart was flushed in situ with two (2) liters of cold preservation solution, recovered, and then placed in a basin with slush for inspection and insertion of the Paragonix SherpaPak™ Heart Connector into the aortic root. A patent foramen ovale was identified and repaired in the basin. The Paragonix SherpaPak™ Heart Connector was attached to the aorta using umbilical tape. The heart was then anchored to the organ canister, which was quickly assembled and inserted into a second rigid sterile outer canister designed for additional protection and serving as a second, rigid sterile barrier. The final assembly was then placed into the Paragonix SherpaPak™ Shipper, which had been previously preconditioned with the Paragonix SherpaCool™ material. Continuous and real-time temperature monitoring and recording was initiated from within the inner canister via an integrated thermocouple probe. The donor heart was now prepared for air transport back to Boston.


Transport to Recipient and Preparation of Donor Heart for Implantation

Flight time from the Southern US back to Boston was approximately 3 hours. According to the transplant team, time of the donor heart removal from the Paragonix SherpaPak™ Shipper and sterile Organ Canisters was considerably shorter and less involved than previous experiences with the ice chest method involving bags or plastic containers. Upon removal of the donor heart from the Paragonix SherpaPak™ CTS, temperature records were downloaded and reviewed.


Transport and Total Ischemic Time

The total time of storage and preservation within the Paragonix SherpaPak™ CTS was 205 minutes. The total ischemic time was 312 minutes.


Transport and Temperature Results

The initial preservation solution temperature within the Paragonix SherpaPak™ Organ Canister holding the donor heart was 5.33°C, with a mean temperature of 5.51°C. The lowest temperature recorded during the transport was 4.48°C and the highest temperature recorded was 6.20°C. These temperatures were within the operating range of 4 to 8°C for optimal preservation and prevention of frostbite and cold damage. The entire Paragonix SherpaPak™ CTS occupied one seat in the aircraft, was easily secured using a conventional seatbelt, and was easily wheeled to and from the aircraft and to the recipient OR.


Patient and Graft Outcome

The patient did well without complications coming off bypass; graft function was excellent. Postoperative TTE showed normal LV and RV function with 72% of LVEF and RHC showed low normal filling pressures and normal cardiac output.


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