[PDF] - Taking the IF Out of Gift: Best Practices for Organ and Tissue PDF Document

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10/14/2015 1

Taking the “IF” Out of Gift: Best Practices for Organ and Tissue Donation

Karl Serrao, MD, FAAP, FCCM

The Challenge

20,000 40,000 60,000 80,000 100,000 120,000

1994 1998 2002 2006 2012

37,684 50,130 60,712 74,093 82,819 85,723 92,000 99,180 118,000 19,043 20,215 21,992 22,827 25,455 26,984 28,932 27,957 28,052 # of pts. waiting # of transplants

Statistics

In 2014, over 29,534 lives

were saved and improved by

rgan transplant (OPTN Data)

Over 7,065 people died in

2014 while waiting for an organ transplant (OPTN Data)

20 deaths each day on the

waiting list (OPTN Data)

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10/14/2015 2 Cowboys Stadium

105,121 (opening day 9-20-09; vs Giants)

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10/14/2015 3 Waiting List

122,489

(National)

13,200

(Texas)

1

(Texan will die today waiting for a transplant)

(Based on OPTN data as of October 12, 2015)

Texas Patients on Waiting List

(as of October 12, 2015) Kidney 10,635 Liver 1,800 Heart 432 Lung 163 Kidney/Pancreas 109 Pancreas 54 Heart/Lung 4 Intestine 1 TOTAL 13,200

In 2014, the generosity of Texas donors led to 2,627 life-saving organ transplants (OPTN Data)

Statistics for Children (0-17 Years)

OPTN Data National Texas

Waiting list (Oct 2015)

2120 212

Died waiting for

transplant (2014) 136 15

Lives saved (2014)

1795 181 Approximately every 3 Days a child will die waiting for a transplant

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10/14/2015 4 Questions To Run On…

 What is my professional obligation in regards

to organ donation?

 How can I best work with organ procurement

rganization (OPO) to increase the number of

transplantable organs in my hospital?

 Can I provide optimal patient care to the brain-

injured individual that preserves the option of donation and best possible outcome for the recipient?

 Is organ transplantation and efforts to obtain

more transplantable organs…'really worth my time and effort…?’

Know Your Organ Procurement Organization (OPO)

How Does the Donor Process Work in Your Hospital?

1. Referral
2. Donor Evaluation
3. Brain Death
4. Family Approach/Consent
5. Donor Management
6. Surgical Recovery

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10/14/2015 5 “An Effective Request Process” Case Study

Upon Admission:

12 year old female; AMS, vomiting, non-verbal, nods to

questions

Intubated in ER; admitted to ICU CT shows ruptured cerebral

aneurysm

PMH: Non-contributory

Case Study

Day 2

Craniotomy
Clinical Triggers met
RN called referral to OPO

Centers for Medicare and Medicaid Services (CMS) requires hospitals to notify OPO within

ne hour of any patient meeting “clinical

triggers” for donation.

Clinical Triggers

Ventilator
Neurological insult
Missing 2 or more reflexes

Age, medical condition, or Medical Examiner involvement does not preclude organ donation

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10/14/2015 6 Case Study

Day 2 (cont’d)

OPO Coordinator arrived on site to evaluate

patient’s donation potential and establish plan with patient’s care team

Huddle to discuss brain death declaration process
physicians, coordinator, nurses, social workers and

chaplains

Patient over-breathing the ventilator; fentanyl and

midazolam for sedation

On-site Evaluation Case Study

Day 3

Patient deteriorates
OPO notified of plan to start brain death exam;

OPO Coordinator dispatched

Patient declared brain dead per clinical exam,

including apnea test

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10/14/2015 7 The Approach Process

Attending physician was very caring with the family:

 Moved to a private, quiet setting.  Explained brain death from a medical standpoint.  Spent time and listened to the family.  Answered the family’s questions;

“What is the next step?”

The Approach Process

Best introduction of the OPO Coordinator:

“Your family has some important decisions to make at this difficult time. This is Laura, and she will help support your family and answer any questions you might have regarding end-of-life decisions for your daughter.”

Collaborative Approach

According to CMS Guidelines,

nly a trained, designated

requestor can mention donation to the family.

For a physician, or other healthcare provider currently caring for the potential donor, to mention donation can be perceived by the family as a conflict of interest.

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10/14/2015 8 Collaborative Approach

OPO Coordinator offered support and explained opportunity to donate:

 Reinforced physician’s explanation of brain

death

 Potential timeline for organ recovery  Directed Donation (opportunity to donate to

someone they know on the waiting list)

 Donation-related hospital costs paid by OPO  Open casket funeral remains an option

Donor Registry/UAGA*

 This patient was not on the Donor Registry

 Patients who are registered are considered

“First Person Consent”

 Texas Health and Safety Code (chapter 692A) also

states:

 Review of medical records and examinations.  Measures to ensure suitability may not be withdrawn. *Uniform Anatomical Gift Act

Lives Saved

Heart: Recovered for research (countless lives saved) R Kidney: 15y F (high school cheerleader; enjoys hunting , fishing and outdoors) L Kidney: 53y M (married with two children; enjoys dominos and watching sports) Liver: 13y M (middle school, video games, baseball) Double Lung: 12y F (middle school, music, choir) Pancreas: 45 y M (pharmacy tech; married; loves gardening and spending time with family)

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10/14/2015 9 What made this case so successful?

 Early recognition of clinical triggers and

referral to Southwest Transplant Alliance

 Frequent huddles to help prepare everyone for

their role in the approach process

 Physician and OPO Coordinator

communicated in order to best meet the needs

f the family

 Medical staff was transparent and honest with

the family about the grave prognosis

Conflict of Interest…

 There is no conflict of interest. The transition

from caring for a critically ill or dying patient to a potential organ donor can be a difficult process for health care providers.

 Treat all patients as though they will survive.

 What’s good for the patient is good for organ

donation.  To avoid the perception of conflict of interest,

the OPO Family Services Coordinator often takes the lead during the approach process.

…in charge and responsible

 Once patient is declared brain dead, the OPO

Medical Director and Coordinator assume responsibility for managing that patient

 The donation process often requires physicians’

support

 Procedures (e.g., place central and arterial lines,

bronchoscopy, echocardiography, etc.)

 Medical management consultation

 OPO Donation Coordinators are specially trained

in donor management

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10/14/2015 10

Evidence-Based Standards of Care

in Donor Management

Catastrophic Brain Injury Guidelines

 MAP > 60 (age appropriate if pediatric)

(Vasopressor support if necessary; Dopamine 1st choice)

 Urine Output > 0.5ml/kg/hr < 4 ml/kg/hr (300 ml/hr )

(Vasopressin if DI)

 Electrolyte balance  Na+ < 155  Hgb/Hct/Coags  pH 7.35–7.45  pO2 > 100  Temp 36-37.5

These goals should be met prior to organ recovery.

Brain Death vs Donation after Circulatory Death

Brain Death

Irreversible cessation of all brain function

including the brain stem. Brain dead donors remain on the vent and vital signs and heartbeat are maintained until organ recovery begins.

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10/14/2015 11 Brain Death vs Donation after Circulatory Death

Donation after Circulatory Death (DCD)

Option for patients who have a non-recoverable illness or

injury that has caused neurological devastation and/or

ther system failure resulting in ventilator dependency;
Patient’s condition is irreversible but patient does not

meet the clinical criteria for brain death;

Determination is made that cardiopulmonary death will

likely occur within 60 min following withdrawal of ventilator support

Family decides to decelerate treatment

Hemodynamic Sequelae of Brain Death

 Sympathetic storm

 Increasing catecholamine levels

 Several hours after brain death, catecholamines

decrease to less than 10% of normal

 Hemodynamic Instability

 Hypertension  Hypotension

 Endocrine abnormalities

 Diabetes Insipidus

Other Sequelae of Brain Death

Electrolyte disturbance Anemia and Coagulopathy Oxygenation issues

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10/14/2015 12 Role of Clinical Care Team

Good Critical Care Patient Management EQUALS Good Donor Medical Management

Intensivists
Pulmonologists
Cardiologists
Nurses
Respiratory Therapists
Spiritual Support
Hemodynamics
Ventilatory Management
Echocardiography
Diagnostic Procedures

Worth our time and effort?

Is it worth my time to take care of these “dead” people? YES! One donor can give life to 8 people

Heart Kidney Liver Pancreas Kidney Lung Lung

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10/14/2015 13 Reality:

With limited time, people and money, it’s important to collaborate internally to get procedures completed. So…what can we do?

Clinical Management of the Organ Donor

 Maintain age appropriate BP  Hypotension secondary to hypovolemia

most common complication

 0.45 percent saline  Albumin  Blood products

Clinical Management of the Organ Donor

 Use of central venous catheter

 Central venous pressure (CVP) : 4-6

 Once patient is adequately fluid resuscitated,

can use vasopressors to maintain adequate BP

 Dopamine  Vasopressin  Neosynephrine  Avoid use of norepinepherine  End-organ damage secondary to hypoperfusion

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10/14/2015 14 Clinical Management of the Organ Donor

 Urine Output

 > 0.5/mL/kg/hr and < 4 mL/kg/hr (400 mL/hr)  Vasopressin 0.5-2.0 u/hr for DI

 Hypernatremia (Na > 155)

 Salt protocol ( fluid depleted)

 Electrolyte Goals

 Potassium (3.5-5.0)  Phosphorus (2.0-4.5)  Magnesium (1.8 – 2.4)  Glucose

Lung Management

 Maintain PO2 > 100 and pH 7.35 to 7.45

 Peep 5 mmH20  Adequate minute ventilation (MV) = RR x Vt  Nebs, CPT, Suctioning, Turning

 Continue hospital VAP prevention protocols  What’s good for the lungs is good for every

rgan

 All organs do well with oxygen  Preventing lung dysfunction is easier than

fixing it

T4 Hormonal Therapy

T4 activates cellular mitochondria to

maintain aerobic respiration

Exogenous T4

 Improves arterial blood pressure  Improves LV EF and CO  Lessens inotropic requirements Rosendale JD, Kauffman HM. Transplant 2003;75:1336-1341. Phongsamran, PV. Progress in Transplantation. 2004;14:105-113. Salim A, et al. Arch Surg. 2001;136:1377-1380.

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10/14/2015 15 Hormonal Therapy & Steroids

Improves donor organ graft

survival rate

Increases tissue oxygenation and

donor organ recovery

Improves cardiac function following

transplantation

Reduces levels of pro-

inflammatory cytokines in tissues

Coagulopathy Management

 Release of large amounts of fibrinolytic

agents and plasminogen activating factors from brain necrosis

 Monitor Hgb/Hct and Coagulation

studies

 Keep Hct >30%  Transfuse FFP, Cryopreciptate and

platelets as needed

What’s the Evidence

 Franklin GA, et al. Am Surg 2009;75:537-543

 15 yr experience of single Organ Procurement

Organization (OPO) from 1993-2008

 Implementation of intensivist program and standard

protocols

 Organs transplanted per donor (OTPD): 2.93 to 3.66

for standard criteria donors

 OPTD in pediatric donors remained constant  3.5-4 OTPD

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10/14/2015 16 What’s the Evidence

Salim A, et al. J Trauma 2005;58:991-994

 Aggressive donor management protocol in  82% increase in actual donors (p<0.001)  87% decrease of donors lost from CV collapse

(p<0.001)

 71% increase in total organs recovered

(p<0.001)

 No difference in organs transplanted per

donor (OTPD)

What’s the Evidence

Rosendale JD, et al. Am J Transplant

2002;2: 761-768

 Donor critical pathway in 88 units in 10

OPO over 4 month period

 10.3% greater number of organs procured

per donor (OPPD) (p <0.01)

 11.3 % greater number of OTPD (p<0.01)

DCH-Donor Management Protocol

Collaborative development:

 Pediatric organ donor management

guidelines and goals

 Protocols using standardized organ

donor management order set

Pediatric Intensivist initiates protocol

upon consent

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10/14/2015 17 DCH- Donor Management Protocol

Comparison

 Pre-protocol period :Jan 2004 –Dec 2008  Post-Protocol Period :Jan 2009 –Dec

2011

Data Collected

 Donor patient demographics  Number and types of organs procured

and transplanted

Demographics

Pre-Protocol Period Post-Protocol Period Median age (yrs) 5.5 (0.17-12) 11 (0.42-14) Sex: Male 13 (77%) 5 (56%) Female 5 (23%) 4 (44%) Total number of donors 18 9 Total number of organs transplanted (N) 59 37

Effects of Organ Donor Protocol

n Organs Transplanted Per Donor

3.28 + 1.22 4.11 + 1.76

1 2 3 4 5 6 Pre-protocol Post-protocol Organs Transplanted per Donor (p=0.08)

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10/14/2015 18 Specific Organ Types Transplanted

41% 24% 57% 100%

0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100%

Heart Kidneys Lungs Liver Pancreas

Organs Transplanted

Pre-Protocol Post-Protocol

Keys to Success

Encourage collaborative approach

Guideline and protocol development Intensivist, PICU and OPO

Active Intensivist participation

Implementation Donor management

…Time Constraints

 Often, families only allow a certain amount of time, so

recovery needs to be expedited.

 ORs are more available during evening hours  Sometimes, the patient’s condition deteriorates rapidly --

nly chance is to expedite the process

 OPO needs to coordinate the following:

 Per Transplant Surgeons’ requests, evaluate

rgans/tissue to determine medical suitability

 Place offers to respective transplant centers  Evaluate responses, place offers to next in line if needed  Secure transplant teams, arrange flights, fly in teams  Schedule operating rooms

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10/14/2015 19

Reimbursed Costs Related to Donor Evaluation & Management

When brain death has been declared and

authorization has been obtained, OPO picks up the bill*

A standard organ acquisition fee is charged

by OPO to the transplant center receiving the

rgan. This fee is added to the transplant

recipient’s hospital bill.

*Hospital and physician charges from the time of authorization are reimbursed to the hospital by OPO

Donation and End-of-Life Care

 Organ donation is an integral part of end-of-life

care

 Organ donation is a medical decision made by

the family in conjunction w/ the medical team

 The option of organ donation should be

ffered to every family during end-of-life care

discussions and decisions

Conclusions

 Know the clinical triggers and make timely

referral calls to OPO.

 Continue to treat patient until patient can be

assessed by OPO.

 Huddle to ensure a Collaborative Approach.  Multidisciplinary donor management.