Randomized Trial to Compare the SherpaPak™ Device vs Cold Storage of Donor Hearts in Transplantation: A Pilot Study
Phase: NA
Conditions: Organ Transplant
Sponsor: Cedars-Sinai Medical Center

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Randomized Trial to Compare the SherpaPak™ Device vs Cold 
Storage of Donor Hearts in Transplantation: A Pilot Study 
 
Version 3,  February 16, 2022 
 
Principal Investigator: 
Fardad Esmailian, MD 
Surgical Director, Heart Transplant Program 
 
Cedars-Sinai Medical Center 
 
 
 
 

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TABLE OF CONTENTS  
 
Protocol Summary ........................................................................................................................................ 3 
General Information .................................................................................................................................... 3 
Protocol Amendment History .................................................................................................................... 3 
1.0 
BACKGROUND, RATIONALE ................................................................................................. 4 
2.0 
STUDY OBJECTIVES ................................................................................................................... 4 
3.0 
STUDY POPULATION ................................................................................................................. 5 
3.1 
Selection of the Study Population ........................................................................................ 5 
3.2 
Inclusion Criteria .................................................................................................................... 5 
3.3 
Exclusion Criteria ................................................................................................................... 5 
3.4 
Subject Screening and Enrollment ....................................................................................... 5 
3.5 
Subject Recruitment ............................................................................................................... 6 
4.0 
STUDY DESIGN AND METHODS .......................................................................................... 6 
4.1 
Schedule of Procedures ......................................................................................................... 7 
5.0 
DATA COLLECTION AND MANAGEMENT ...................................................................... 7 
5.1 
Data Procurement .................................................................................................................. 7 
5.2 
Time Period of Data Under Review .................................................................................... 8 
5.3 
Variables Collected ................................................................................................................. 8 
5.4 
Source Documents ................................................................................................................. 9 
5.5 
Data Collection and Storage ................................................................................................. 9 
5.6 
Confidentiality and Security of Data .................................................................................. 10 
6.0 
DATA AND SAFETY MONITORING ................................................................................... 10 
6.1 
Data and Safety Monitoring Plan ....................................................................................... 10 
6.2 
Quality Control and Quality Assurance ............................................................................ 12 
7.0 
STATISTICAL CONSIDERATIONS ....................................................................................... 13 
7.1 
Study Outcome Measures .................................................................................................... 13 
7.2 
Sample Size Considerations ................................................................................................ 13 
8.0 REFERENCES .................................................................................................................................... 13 
 
 

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PROTOCOL SUMMARY  
Purpose and Knowledge to be 
Gained 
 
The purpose the research is to compare the SherpaPak™ 
Cardiac Transport System to standard of care cold storage of 
donor hearts for transplantation. 
 
Successful use of this device may decrease cold injury of donor 
hearts by maintaining the temperature consistently during 
transport and therefore may decrease primary graft dysfunction 
after transplantation. 
Research Procedures 
 
The primary research procedure is the use of the SherpaPak 
Cardiac Transport System for the preservation and transport of 
donor hearts for transplantation 
Subject Population 
Patients listed for heart transplant at Cedars-Sinai 
Duration 
The study includes 6 visits.  
The total study duration is 30 days 
 
GENERAL INFORMATION  
Sponsor/Funder 
Internally Funded 
Collaborating Institutions 
Involved in the Research 
Not Applicable 
 
PROTOCOL AMENDMENT HISTORY  
Protocol Version 
Summary of Changes/Rationale for Changes 
Protocol V3: February 16, 2022  - Removed CSMC Co-Investigators section under General 
Information as this section would be too large 
- Section 3.3 Exclusion Criteria removed all exclusion criteria 
- Section 4.0 Study Design, Schedule of Procedures updated 
to add Randomization at Visit 1, extend the visit #6 
window and clarify timing of biopsy tissue collection  
- Section 5.1 Data Procurement removal of AHD Registry 
language as this registry will not be utilized  
- Minor revisions throughout protocol for clarity  
- Section 6.0 Data Safety Monitoring, language regarding the 
DSMB Charter has been inserted  
- Formatting revised throughout 
Initial Protocol V2: July 15, 
2021 
N/A  

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1.0 BACKGROUND, RATIONALE  
 
Cardiac transplantation is currently the procedure of choice for selected patients with end-stage 
heart disease that is not amenable to further medical intervention or conventional cardiac 
procedures.  Successful organ preservation is an important component of transplantation and 
ensures the maintenance of organ viability until implantation into the recipient.  Currently, heart 
preservation for transplantation is limited to 4 to 6 hours of cold ischemic storage.  Longer periods 
of ischemia are associated with poor outcomes post transplantation.  In heart transplantation, 
preservation injury and ischemic reperfusion injury contribute to microvascular dysfunction and 
myocardial injury leading to primary graft dysfunction or to the activation of pro-inflammatory and 
pro-fibrotic processes, and the development of cardiac fibrosis and allograft vasculopathy.   
 
In general, instructions for the use of organ preservation solutions state a temperature range of 2-
8°C or 4-8°C, balancing the risk of cold injury at lower temperatures against the risk of hypoxic 
injury at higher temperatures.  The standard method of storing donor hearts in preservation fluid 
within sequential bags that are then placed on ice and transported in a cooler does not allow for 
exact temperature control.  The SherpaPak™ Cardiac Transport System has been developed to 
provide a safe, consistent method for cold ischemic storage of donor hearts for transplantation.  
Successful use of this device may decrease cold injury of donor hearts by maintaining the 
temperature consistently during transport and therefore may decrease primary graft dysfunction 
after transplantation. 
2.0 STUDY OBJECTIVES 
 
Primary Objective 
To compare the SherpaPak™ Cardiac Transport System to standard of care cold storage of donor 
hearts for transplantation. 
 
Secondary Objective 
To assess for a decrease in cold injury of donor hearts and therefore a decrease in primary graft 
dysfunction.  To assess for events between study groups.   
 
Primary Endpoint 
The primary endpoint will be a composite endpoint of:  Absence of moderate to severe primary 
graft dysfunction per ISHLT grading scale (left or right ventricle) in the first 24 hours post 
transplantation, and 30-day patient survival, 30-day incidence of ischemic reperfusion injury on 
endomyocardial biopsies and changes in mitochondria function and quality (at donor heart 
harvesting, at the time just prior to donor heart implantation and at one-week post- heart 
transplantation). 
 
Secondary Endpoints – To describe between the groups 
1. Each individual component of the composite endpoint will be assessed. 
2. Hemodynamic parameters including cardiac index, cardiac output, blood pressure, mean 
arterial pressure, pulmonary artery pressure, left atrial pressure, right atrial pressure, right 

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ventricular pressure, stroke volume and ejection fraction at 24 hours post-transplant 
3. The number of inotropes/pressors at 24 hours post -transplant. 
4. Incidence of acute cellular rejection in the first 30 days post heart transplantation. 
5. Incidence of antibody mediated rejection in the first 30 days post heart transplantation. 
6. Incidence of heart graft related Serious Adverse Events in the first 30 days post heart 
transplantation. 
7. Total length of stay 
8. ICU length of stay 
9. Number of blood products used 
3.0 STUDY POPULATION  
3.1 SELECTION OF THE STUDY POPULATION 
• Study subjects will be drawn from patients listed for heart transplant at Cedars-Sinai 
Medical Center. 
3.2 INCLUSION CRITERIA 
• Any sex/gender, 18 years of age or older listed for heart transplant. 
• Subjects must be willing and be capable of understanding the purpose and risks of 
the study and must sign a statement of informed consent OR consent of a legally 
authorized representative of a cognitively impaired individual will be obtained before 
the cognitively impaired individual may be included in research. 
• Signed: 1) written informed consent document and 2) authorization to use and 
disclose protected health information 
• Subjects must receive and accept a non-local donor offer (from Northern California, 
Arizona, Nevada or farther geographies) 
3.3 EXCLUSION CRITERIA  
Not Applicable  
3.4 SUBJECT SCREENING AND ENROLLMENT 
All patients on the heart transplant waiting list at Cedars-Sinai will be identified by trial 
investigators and screened for trial eligibility. Those patients who initially appear eligible for 
the trial will have the trial thoroughly explained to them by a trial investigator, be invited to 
participate, and will be asked to sign an informed consent. Consent of a legally authorized 
representative of a cognitively impaired individual will be obtained before the cognitively 
impaired individual may be included in research.  
 
When a matching donor heart becomes available, the inclusion and exclusion criteria will be 
re-verified by the study team. If the recipient is no longer eligible for the trial, they will be 
considered a screen failure and they will exit the study and no information will be collected 
for these patients. 
 
If the subject is matched with a donor heart from a local donor (Southern California), the 

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subject will be considered a screen failure and they will exit the study and no information will 
be collected for these patients. 
 
When a matching donor heart from a non-local donor offer (from Northern California, 
Arizona, Nevada or farther geographies) becomes available the recipient will be assigned a 
subject identification number and randomized 1:1 to receive a heart transported using either 
standard of care cold storage or the SherpaPak™ Cardiac Transport System. REDCap will 
be used for randomization. 
3.5 SUBJECT RECRUITMENT 
All subjects will be patients of the principal investigator and co-investigators, managed as 
part of the Cedars-Sinai Advanced Heart Failure/Heart Transplant Program.  Subjects will 
be approached in person during clinic visits or upon hospital admission by investigators or 
study coordinators after confirming eligibility.  No advertising will be used for recruitment 
purposes. 
4.0 STUDY DESIGN AND METHODS 
 
This study is designed to be conducted as a single-center randomized prospective trial to compare 
the SherpaPak™ Cardiac Transport System to standard of care cold storage for donor hearts in 
transplantation.  Approximately 20 consented subjects will receive a donor heart transported using 
either cold storage or the SherpaPak™ Cardiac Transport System, respectively. Both methods are 
FDA approved. 
 
Donor hearts will be screened for eligibility based on current standard of care criteria.  Heart 
transplant candidates will be screened for trial eligibility.  Every eligible candidate will be asked to 
participate. Eligible and consented transplant candidates will receive donor hearts transported using 
standard of care cold storage or the SherpaPak™ Cardiac Transport System, that have been deemed 
clinically acceptable for transplantation by the treating transplant clinical team. 
 
The study will be evaluating the comparative use of two FDA-approved methods for organ 
procurement. The research procedures will be randomization, data collection/analysis, and tissue 
collection from standard of care biopsies for mitochondrial testing.  
 
Mitochondrial Testing 
Biopsy tissue from donor hearts will be collected prior to transport, prior to transplant and at one-
week post-transplant. The tissue will be evaluated to detect changes in mitochondrial function and 
regulation. 
 
Biopsy tissue will be processed and stored by the Gottlieb Laboratory at Cedars-Sinai.  The Gottlieb 
Laboratory, led by Roberta A. Gottlieb, MD, is studying the molecular mechanisms regulating 
mitochondria in the heart’s response to ischemic injury. 
 

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4.1 SCHEDULE OF PROCEDURES 
 
Procedures/Assessments  
Screening 
Visit 
Visit 1 
(Day 0 at 
Transplant) 
Visit #2 
(Day 7 post-
transplant ± 
2 days) 
Visit #3 
(Day 14 
post-
transplant 
± 2 days) 
Visit #4 
(Day 21 
post-
transplant 
± 2 days) 
Visit #5 
(at hospital 
discharge) 
Visit #6 
(Day 30 
post-
transplant 
± 14 days) 
Eligibility & Informed 
Consent 
X 
 
 
 
 
 
 
Demographics/Characteristics 
X 
 
 
 
 
 
 
Medical & Cardiac History 
X 
 
 
 
 
 
 
Confirm 
Eligibility/Randomize 
 
X 
 
 
 
 
 
Data Collection Donor 
Characteristics 
 
X 
 
 
 
 
 
Patient Visit (recipient) 
X 
X 
X 
X 
X 
X 
X 
Tissue Collection for biopsy 
(donor heart prior to transport 
& prior to transplant) 
 
X 
X 
 
 
 
 
Mitochondrial Testing 
 
X 
X 
 
 
 
 
Data Collection Transplant 
Details 
 
X 
 
 
 
 
 
Data Collection PGD Scores 
 
X 
X 
 
 
 
X 
Data Collection Inotrope 
Support 
 
X 
X 
 
 
X 
X 
Right Heart Catheter Data 
 
X 
 
 
 
 
 
Data Collection Mechanical 
Circulatory Support 
 
X 
X 
 
 
X 
X 
Data Collection Invasive 
Ventilator Support 
 
X 
X 
 
 
 
 
Endomyocardial Biopsy 
(recipient) 
 
 
X 
X 
X 
 
X 
Data Collection Patient 
Survival 
 
 
 
 
 
 
X 
Data Collection Graft Survival 
 
 
 
 
 
 
X 
Data Collection Post-
Transplant Hemodynamics 
 
X 
X 
 
 
 
X 
Data Collection 
Immunosuppressive Meds & 
Induction (if applicable) 
 
X 
X 
 
 
X 
X 
Data Collection ICU & 
Hospital Stay 
 
 
 
 
 
X 
 
Data Collection Heart Graft-
Related AEs and SAEs 
 
X 
X 
X 
X 
X 
X 
5.0 DATA COLLECTION AND MANAGEMENT 
5.1 DATA PROCUREMENT 
Except for mitochondrial studies (research), all data collected will already exist in the medical 
record under standard of care. Tissue collected will undergo mitochondrial studies.  

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5.2 TIME PERIOD OF DATA UNDER REVIEW 
• Data will be reviewed from the dates of 9/01/2021 to 8/31/2023. Data will be 
collected from the following timepoints: Post-heart transplant Day 0, Day 7, Day 14, 
Day 30 and at hospital discharge.  Data will be collected prospectively and 
retrospectively. 
• Information will be kept in REDCap for two years after the conclusion of the study. 
5.3 VARIABLES COLLECTED  
The following data points/variables will be collected: 
• Incidence of primary graft dysfunction 
• Initial use of mechanical circulator support: The use of ECMO, intra-aortic balloon, 
LVAD, RVAD or biVAD 
• Number of inotropes/pressors at 24 hours post-transplant 
• Inotropic support for first 72 hours:  The following inotropic medication doses will 
be collected at ICU admission T0, T12, T24, T48, and T72 hours after ICU 
admission post-heart transplantation:  
o Dopamine – mcg/kg/min  
o Dobutamine – mcg/kg/min  
o Amrinone – mcg/kg/min  
o Milrinone – mcg/kg/min  
o Epinephrine – mcg/kg/min  
o Norepinephrine – mcg/kg/min  
• Initial use of mechanical respiratory support: Duration of initial post-transplant 
invasive ventilator support from time of initial admission to ICU post heart 
transplant until extubation 
• Immunosuppression Medications (at day 7 and at time of discharge) 
• Incidence of reperfusion injury on endomyocardial biopsy 
• Cardiac index 
• Cardiac output 
• Blood pressure 
• Mean arterial pressure 
• Pulmonary artery pressure 
• Pulmonary capillary wedge pressure 
• Left atrial pressure 
• Right atrial pressure 
• Right ventricular pressure 
• Stroke volume 
• Ejection fraction 
• BUN and Creatinine 
• Liver function tests 

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• Cellular rejection 
• Antibody mediated rejection 
• Graft-related serious adverse events 
• Mitochondrial function 
• Age at transplant 
• Sex 
• Donor characteristics 
• Total cross clamp duration in minutes 
• Ischemic time 
• Surgical complications 
• Total length of stay 
• ICU length of stay 
• Total blood products used 
• Trans-thoracic echocardiogram results prior to discharge: 
o Ejection Fraction (EF%) 
o Wall motion assessment 
o LV Septal and posterior wall thickness 
o Any valve abnormalities 
• Patient and graft survival at day 30 
• Incidence of acute cellular rejection in the first 30 days post heart transplant 
• Incidence of antibody mediated rejection in the first 30 days post heart transplant 
• Adverse events:  All heart graft-related serious adverse events and any heart graft-
related adverse events will be followed and documented until the investigator 
designates the event to be either resolved or its effect on the patient’s condition 
stabilized. 
• Medications: Medications used to treat all serious heart graft-related adverse events 
(SAEs) until the SAE is resolved. 
5.4 SOURCE DOCUMENTS 
• Source documents are defined as the results of original observations and activities of 
a clinical investigation.  Source documents will include, but are not limited to, 
progress notes, electronic data, computer printouts, screening logs, and recorded 
data from automated instruments.  All source documents pertaining to this trial will 
be maintained by the investigators and made available for inspection by authorized 
persons. 
5.5 DATA COLLECTION AND STORAGE  
• During each subject assessment, an investigator participating in the trial will record 
progress notes to document all significant observations. In addition, any contact with 
the subject via telephone or other means that provides significant clinical 
information will also be documented in the progress notes.  
• All data required by the trial protocol will be completely and accurately entered into 
the REDCap database by the investigator or his or her designate, identifying subjects 

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by subject number. 
• Essential trial documents must be maintained by the Investigator for at least 7 years.  
• Storage of Physical Records: Physical records will be maintained for this study at a 
secure location where access is limited to approved personnel. The records will not 
be removed from Cedars-Sinai premises. 
• Storage of Specimens: Specimens will be maintained for this study at a secure 
location where access is limited to approved personnel. The specimens will not be 
removed from Cedars-Sinai premises. 
5.6 CONFIDENTIALITY AND SECURITY OF DATA 
• Secure storage: Data will be housed in a HIPAA-compliant secure storage system, 
like REDCap or Box, within the Cedars-Sinai network with access restricted to 
approved members of the research team.  
• Limited Access: Private identifiable information, will be accessible only to IRB 
approved study team members with current IRB training. 
• Unique ID Numbers: Each patient will be assigned a unique ID number, which 
will be used to code data and specimens.  
6.0 DATA AND SAFETY MONITORING  
6.1 DATA AND SAFETY MONITORING PLAN 
Safety will be analyzed principally by examination of the frequency of adverse events. In 
particular, the number of donor heart graft-related serious adverse events (SAEs) up to the 
30-day follow-up after transplantation per subject will be analyzed. This endpoint is defined 
to consist of the following adverse events (at most one per type), if they are serious adverse 
events: 
• Primary heart graft dysfunction (not including rejection or cardiac tamponade): 
o Use of ECMO, RVAD, LVAD, BiVAD or insertion of a new IABP for >12 
hours post TX. 
o Use of ≥ 2 inotropic agents/vasopressors including high-dose epinephrine or 
norepinephrine for >7 days post heart TX. 
o Open chest post heart TX. due to compromised heart function 
• Primary graft failure requiring re-transplantation 
 
Subjects will be monitored before, during and after the operative procedure to help ensure 
their safety. The investigators are members of transplant teams who have extensive 
experience with heart transplants and who will be trained to use the SherpaPak Cardiac 
Transport System to further minimize risk. 
 
Subjects in the trial will undergo frequent visits and routine monitoring to help detect any 
abnormal changes and to provide appropriate treatment as necessary. 
 
An independent Data and Safety Monitoring Board (DSMB) comprised of two expert heart 
failure physicians and one cardiothoracic surgeon not participating in the trial, will perform 

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monitoring activities to ensure the identification, documentation, and analysis of adverse 
events; and to ensure compliance with the protocol and procedures that are in place for 
conducting research to protect the safety and well-being of all subjects.  The DSMB will 
have a formal meeting at least once annually. Frequency of the meetings may be changed by 
the DSMB in consultation with the Principal Investigator based on need. An ad hoc meeting 
may be called at any time by the Chairperson or by the PI and research staff should ethical 
or patient safety issues arise. 
 
A status update will also be provided to the DSMB on a quarterly basis via email 
correspondence by the DSMB Coordinator. 
 
The criteria below provide guidance for suspending trial enrollment/randomization until 
review by the DSMB. Selected serious adverse events (SAEs) of concern and their 
thresholds are: 
• Two (2) episodes of severe primary graft dysfunction (PGD) per ISHLT grading 
criteria (left or right ventricle, not including rejection or cardiac tamponade) 
requiring use of a mechanical circulatory support (MCS) device within 24 hours after 
transplant in subjects randomized to the SherpaPak method of transport. 
• Two (2) deaths occur in subjects randomized to the SherpaPak method of transport 
within 7 days after transplant. 
 
It is the responsibility of the Principal Investigator to report all of the above SAEs to the 
DSMB within 24 hours of discovering the event. 
 
In the event that the study is suspended, no new subjects will be consented or randomized 
to the trial. Subjects already in follow-up on the study will continue to be followed as 
outlined in the protocol unless the appointed Chair provides further recommendations. 
 
All heart graft-related adverse events and serious adverse events are to be recorded on the 
electronic case report forms until post-transplant day 30. The description of the adverse 
event will include: the date of onset, duration, severity, seriousness, the relationship of the 
event to the trial treatment, anticipated or not, and any treatment required. All serious 
adverse events occurring during the course of the first 30 days post-transplant will be 
documented on the appropriate electronic case report form(s) in REDCap. Heart graft-
related AEs will be recorded up to the 30-day follow-up or through hospital discharge if 
longer than 30 days. The principal investigator is responsible for the classification and 
reporting of heart graft-related adverse events to the appropriate regulatory authorities. 
 
A SAE is any AE that in the view of the Investigator results in death, is life-threatening, 
requires inpatient hospitalization or causes prolongation of existing hospitalization. In the 
interest of patient safety, and in order to fulfill regulatory requirements, all SAEs (regardless 
of their relationship to the study procedures) will be documented and reported per IRB 
guidelines.  In the interest of this study, the SAEs that meet the stopping rule criteria within 
the DSMB Charter, will be submitted to the DSMB for review.  
 

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Heart-graft related-AEs will be captured in this study. The investigator will assess the 
relationship of the AE to the SherpaPak Cardiac Transport System or to the standard of care 
methods of preservation. The relationship will be assessed using the following categories: 
• Definitely Related: There is a reasonable causal and temporal relationship between 
preservation with the SherpaPak Cardiac Transport System and the adverse event. 
• Probably Related: It is more likely than not that there is a reasonable causal 
relationship between preservation with the SherpaPak Cardiac Transport System and 
the adverse event. 
• Possibly Related: There is a reasonable relationship with preservation with the 
SherpaPak Cardiac Transport System and the adverse event, but the causal 
relationship is unclear or lacking. 
• Unlikely Related: There is a temporal relationship with preservation with the 
SherpaPak Cardiac Transport System and the adverse event, but there is not a 
reasonable causal relationship between the trial device and the event. 
• Unrelated: There is no relationship between preservation with the SherpaPak Cardiac 
Transport System and the adverse event. 
 
The investigator will rate the severity of the adverse event using the following categories: 
• Mild: The adverse event is transient and/or easily tolerated by the subject. 
• Moderate: The adverse event causes the subject discomfort and interrupts the 
subject's usual activities. 
• Severe: The adverse event causes considerable interference with the subject's usual 
activities. 
 
During the trial, investigators will be responsible for complete and accurate entry of data 
into the trial’s REDCap database, and will maintain on file the following accurate, complete 
and current records relating to this trial: 
• All relevant correspondences and required reports that pertain to the trial 
• Records of receipt, use or disposition of the investigational device, including the type 
and quantity of the device; the dates of receipt; the lot number; the names of all 
persons who received, used or disposed of each device; and why and how any units 
of the device have been returned to the Sponsor, repaired, or otherwise disposed 
• Records of each subject’s case history and exposure to the device 
• Signed and dated consent forms 
• Protocol, and any amendments 
• Investigator curriculum vitae 
6.2 QUALITY CONTROL AND QUALITY ASSURANCE 
• The investigator is required to keep accurate records to ensure that the conduct of 
the study is fully documented. An internal auditor will regularly review the conduct 
of the trial, verify adherence to the protocol, and confirm the completeness, 
consistency, and accuracy of all documented data. 
 

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7.0 STATISTICAL CONSIDERATIONS  
7.1 STUDY OUTCOME MEASURES 
Continuous variables will be summarized using descriptive statistics, specifically the mean, 
median, standard deviation, minimum, and maximum. Categorical variables will be 
summarized using frequencies and percentages. 
7.2 SAMPLE SIZE CONSIDERATIONS  
The study is intended to serve as a proof of concept study. Comparative analyses will be 
primarily descriptive due to a small sample size. 
 
8.0 REFERENCES 
1. Radakovic D, Karimli S, Penov K, Schade I, Hamouda K, Bening C, Leyh RG, Aleksic I. 
First clinical experience with the novel cold storage SherpaPak™ system for donor 
heart transportation. J Thorac Dis. 2020 Dec;12(12):7227-7235. doi: 10.21037/jtd-20-
1827. PMID: 33447411; PMCID: PMC7797872. 
 
2. Mohite PN, Sef D, Umakumar K, Maunz O, Smail H, Stock U. Utilization of Paragonix 
SherpaPak for human donor heart preservation. Multimed Man Cardiothorac Surg. 
2021 Jun 16;2021. doi: 10.1510/mmcts.2021.035. PMID: 34143579. 
 
3. Iyengar A, Atluri P. Commentary: Keeping your cool: Donor heart preservation using 
the SherpaPak Cardiac Transport System. J Thorac Cardiovasc Surg. 2020 
Feb;159(2):e125-e126. doi: 10.1016/j.jtcvs.2019.06.077. Epub 2019 Jul 18. PMID: 
31405590.