PowerPoint Presentation (PDF) - Perfusion.com

VAD’s and Simulation:
Can accidents be prevented di
in
an MCS program?
David Fitzgerald, BS, CCP
Chief of Cardiovascular Perfusion
INOVA Heart and Vascular Institute
Falls Church, VA

Disclosures
• Terumo Cardiovascular
• Speaker- Honorarium
• Focus Panel- Honorarium
• Medtronic
• Focus Panel- Honorarium

U.S. Airways Flight 1549

U.S. Flight 1549

“This is for the birds”
• 1 out of every 7,000 flights
encounters a bird strike.
• Over 49,000 flights per day
in the world
• 25 million flights/year
• 1.7 billion passengers/yr.
• Only 7 other documented
crashes from bird strikes in
the history of aviation.
Source: faa.com

Airline Industry
•Pillars of Aviation
•Standardization
•Redundancy
•Experience
•Simulation

Flight Simulation

Perfusion Simulation

Simulation in Training
• Offered when it is too dangerous or expensive
to allow trainees to use real life “equipment”
• Spend time learning valuable skills in a “safe”
virtual environment.
• Can permit mistakes during training i for a safety-
critical system.
• Avoid “learning on the job behaviors”
-Wikipedia

Training Simulations
• Training simulations come in 3 categories
• “Live” simulation: simulated equipment in the real
world
• “Virtual” simulation: simulated equipment in a
virtual environment
• “Constructive” simulation: simulated equipment in a
simulated world.
• War-gaming

Medical Errors in the Hospital
“To Err is Human”- Institute of
• 1.5 million estimated annual
preventable hospital errors
Medicine-1999
• An estimated 98,000 patients die
from medical errors.
• > MVA’s, breast cancer, or AIDS.
• IOM suggested that hospital
errors should be reduced by 50%
over 5 years.

Medical Simulation
• High-fidelity virtual reality platforms
• Rehearse high-risk skills
• Even the most experienced clinicians can’t always anticipate a
crisis event.
• Develop valid teaching and evaluation tools
• Bridge between classroom learning and real-life life clinical
experience
• May raise the bar for objectivity and fairness in evaluation.
• Learning experiences can be customized.
• Learn valuable lessons in a “safe” work environment
• “Patient died. Oops. Let’s try again!”
• Improve current quality of delivered d
care
• Opportunities to express needs to manufacturers

Medical Simulation (cont’d)
• Medical simulation centers are expanding.
• 161 current listings- Society for Simulation in Healthcare
• Scope of services
• Blood draws
• Deliveries
• Trauma
• Surgical service
• Prototyping new devices.
• R & D for new therapies and treatments.

Government & Simulation
Enhancing Safety
In Medicine
Utilizing
Leading
Advanced
d Simulation
i Technologies to Improve
Outcomes
Now Act of 2009, H.R. 855
• Amend public health service act to authorize medical
simulation enhancement
• Requires Director of the Agency for Healthcare
Research h&Q Quality to enhance deployment of
simulation technologies
• Rf Referred dt to the House Committee on Energy and
Commerce.

The Enhancing SIMULATION Act
• Establish centers for excellence for simulation
• Promote innovation
• Research, evaluations, initiatives
i i i
• Award grants for deploying technologies
• Funding for:
• Medical, Nursing, Allied Health, Podiatry,
Osteopathic medicine, Dental

Heart Failure
• 4.9 million people affected in U.S., 25 million in the
world.
• 550,000 new cases diagnosed every year
• More hospital ld days are spent for heart failure than any
other diagnosis.
• Heart transplantation is the standard of care
• Available donor hearts/yr.- approx. 2100
• Survival outlook

• > 65 and over
• 348,000 in 1980
Heart Failure
• 807,000 in 2006 (131% increase)
• 2002-2006: 2006: Relative risk of hospitalization was 1.37
times higher than 1980-19841984
• Heart Failure expected to reach $34 billion in 2009.
• Over the next decades, the number of U.S. adults age
65 and older will double to a projected 70 million, and
more than one in five will be 65 or older by the year
2030.

History of Ventricular Assist Devices
• Over 25 years and counting.
• Approximately 1/3 of patients with VAD implanted as
a BTT will not survive to transplantation
• Multi-organ failure
• Infection
• RV failure
• Bleeding
• Patient selection and pre-op preparation are key
ingredients for successful outcomes.
• Infection control and nutrition.

Evolution of Mechanical Assist

In 1994……..
Nancy Kerrigan…Meet
Tonya Harding
World Series cancelled

In 1994……..
The Juice is Loose!
U.S. Gross Debt- 4.6 trillion
2009 Gross Debt- 10.6 trillion

In 2009......

Ventricular Assist Devices
• Functional Recovery
• Abiomed, Centrimag, ECMO
• Bridge to Transplantation
• PVAD/IVAD, Heartmate XVE, HMII, Novacor,
Jarvik, DeBakey
• Destination Therapy
• Heartmate XVE
• Total Artificial Hearts
• CardioWest, Abiocor

• Registry launched June
2006
• Retrospective and
prospective collection
• 1682 patients enrolled
• 98 activated hospitals
• 95 centers entered at
least 1 patient
• 57 CMS certified
destination therapy
centers
INTERMACS ® Registry
Center Enrollment

INTERMACS ® Registry Patient Enrollment
(3/1/2006-3/31/2009) 3/31/2009)

INTERMACS ® Registry Patient
Demographics
(3/1/2006-3/31/2009) 3/31/2009)
800
700
600
500
400
300
200
100
0
48
729
453
245
Patient Age at Implant
1
0-18
19-39
40-59
60-79
80+

Trends in Heart Transplants (UNOS: 1975-2006).
Source: United Network for OrganSharing (UNOS), scientific
registry data.
Number of Trans plants
2,500
2,000
1,500
1,000
500
0
22 57
719
2,363
2,107 2,199 2,192
75 80 85 90 95 00 06
Years

REMATCH Study
• Randomized Evaluation of Mechanical Assistance
for the Treatment of Congestive Heart Failure
• Chronic heart failure patients, NYHA Class IV, not
eligible ibl for transplantation
t ti
• Heartmate XVE vs. optimal medical management
• 48% reduction in death vs. OMM
• Quality of life improved vs. OMM
• 2002- FDA approved XVE as long-term
destination therapy device
• Reimbursement from CMS for DT applications

Destination Therapy

INTERMACS ® Registry Patient Survival
(6/23/2006-3/31/2009) 3/31/2009)

Can We Improve Outcome??
• FDA Database
• M.A.U.D.E. (Manufacturer & User Facility Device
Experience)
• Reports of adverse events involving medical
devices.
• User facility reports (voluntary)- 1991
• Distributor ib reports- 1993
• Manufacturer reports- 1996

Reported VAD Events
• Since 1996:
• 863 reported events
• 579 pump malfunctions
• 250 patient injuries
• 77 patient t deaths
* Thoratec, Abiomed, Jarvik, TCI, Syncardia,
Novacor, Ventracor, Heartware, Levitronix,
TandemHeart, Debakey Micromed.

• Expanding technology
VAD Simulation
• More patients are eligible-DT gb therapy
• Number of available organs has peaked
• Eliminate the “Boutique” model of training
• See one, do one, teach one
• Low volume / high risk procedures
• Most critically-ill ill patients on service
• # of available devices is expanding
• Newer generation devices operate differently than
previous models, more durable.
• 2 year vs. 10 year length of support

VAD Simulation (cont’d)
• VAD training is often relied upon by the
manufacturer.
r
• VAD physiology is “counter-intuitive” to
conventional medicine
• Pulse-less less devices (valve-free, laminar flow)
• No CPR for cardiac arrest
• No EKG- TAH
• Joint Commission
• DT therapy certification for MCS programs
• Disease-specific specific care for MCS patients

If you Build it, They will Come!
# of MCS Patients at INOVA
40
35
30
25
20
15
10
5
0
1989 1990 1991 1992 1993 1994 1995 1996 1997 1998 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008

Modern Orchestra

Modern Orchestra

Modern Orchestra
1. Violins 6. Flutes 11. Trumpets
2. 2nd Violins 7. Oboes 12. Trombone
3. Violas 8. Clarinets 13. Timpani
4. Cellos 9. Bassoons 14. Harp
5. 2nd Basses 10. Horns

Mechanical Assist Program
1. Surgeon 6. Blood Bank 11. Social Worker
2. VAD Coord.
7. ICU RN 12. P.T.
3. Perfusion 8. Intensivist
13. Administration
4. Anesthesia 9. Bio-Med
14. EMS / Hospice
5. O.R. RN 10. Telemetry RN

VAD Simulation
• VAD Coordinators
• Perfusion
• ICU / Telemetry RN’s
• Bio-engineers
• Physicians
• Social Workers
• EMS/First responders
r
• Hospice caregivers

Case Scenario #1
(Surgeon)
Patient that received a 4-vessel CABG did not successfully
wean from lengthy CPB support. Suspecting an intra-
operative MI, the surgeon decided to perform an Abiomed
RVAD insertion. After the insertion and a successful wean
from CPB, the surgeon lifted the heart to inspect for bleeding
at the anastomosissite. site. During lifting, i the side holes of the
atrial cannula were exposed and air was introduced to the
VAD pump.
- Air embolism emergencies

Case Scenario #2
(Scrub Nurse)
During a Centrimag LVAD insertion in the operating room
the perfusionist hands the primed sterile lines to the field for
connection to the catheter. The surgeon asks for inflow
tubing and outflow tubing, respectively. The scrub nurse
accidentally hands the lines up in reverse order. After the
cessation of CPB and the VAD is started, the surgeon notices
the heart acutely swell and the arterial pressure plummet. The
surgeon asks the perfusionist to increase the VAD flow to off-
load the ventricle. The condition worsens, forcing the re-
initiation of CPB support.
- Table lines reversed, flow path Ao-LV.

Case Scenario #3
(Caregiver)
Patient is on HMII support and is seemingly making steady
progress on the telemetry floor. Discharge orders are being
written by the P.A. During the interview the patient
complains of new-onset lethargy and a weakened appetite.
The P.A. determines that the pump flow is less than normal
and decides to increase the pump speed by 400 RPM, resulting
in an much improved C.I. The P.A. leaves after the consult.
Moments later, the patient de-compensates and cardiac arrest
ensues.
Ventricular suck-down; quick RPM changes

Case Scenario #4
(Paramedic)
EMS providers respond to a call of a Heartmate XVE patient
in distress. Patient’s chief complaint is dizziness. Upon
arrival, EMS providers attach an ECG monitor and quickly
reveal lth the patient ti is in v-tach
tach. The paramedics attempt t to
defibrillate the patient and in doing so short circuit the system
controller. The pump stops and hand-pumping is now
necessary to maintain support.
Disconnect system monitor before cardioversion;
handpumping p and/or system controller change-out required

Case Scenario #5
(Patient)
A newly discharged D.T. patient with a Heartmate
XVE accompanies his wife to see a movie at the
theater. The length of the movie is 2.5 hours,
short enough for him to see the movie under 1
set of batteries. He decides to leave his extra
batteries and hand pump in the car. After the
movie he realizes their car was stolen. He has
approximately 45 minutes of charge left on his
current set.

Conclusions
• Simulation is paramount in 21 st century medical
training programs.
• The number of MCS patients continues to
increase.
• Simulation i could offer valuable lesson-learned
learned
experiences to MCS caregivers.
• Could simulation prevent VAD accidents?

Thank You