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Mechanical Circulatory Device (MCD) – Adult – Inpatient/Ambulatory

Mechanical Circulatory Device (MCD) – Adult – Inpatient/Ambulatory - Clinical Hub, UW Health Clinical Tool Search, UW Health Clinical Tool Search, Clinical Practice Guidelines, Cardiovascular


1
Mechanical Circulatory Device (MCD)
– Adult – Inpatient/Ambulatory
Clinical Practice Guideline
Table of Contents
EXECUTIVE SUMMARY ........................................................................................................... 3
SCOPE ...................................................................................................................................... 3
METHODOLOGY ...................................................................................................................... 4
DEFINITIONS ............................................................................................................................ 5
INTRODUCTION ....................................................................................................................... 5
RECOMMENDATIONS .............................................................................................................. 5
Pre-MCD Assessment ........................................................................................................ 5
Indication/ Contraindication for Destination Therapy ........................................................... 8
Indication Criteria for Bridge to Transplant .......................................................................... 9
PreMCD Surgery Preparation ........................................................................................... 11
Intra-Operative Management ............................................................................................ 11
Postop Guidelines ............................................................................................................ 12
Outpatient Management ................................................................................................... 24
CentriMag (Thoratec) ....................................................................................................... 28
HeartMate II LVAD ........................................................................................................... 34
Heartware HVAD .............................................................................................................. 39
Thoratec TLC ii 2001, IVAD 2004, Dual Drive Console ..................................................... 43
Total Artificial Heart (Syncardia) ....................................................................................... 48
Guideline for Inpatient Rehab ........................................................................................... 55
Maintenance of Mechanical Circulatory Device Equipment ............................................... 56
UW HEALTH IMPLEMENTATION ............................................................................................58
APPENDIX A. INTERMACS PROFILES OF ADVANCED HEART FAILURE ..........................59
REFERENCES .........................................................................................................................61
Copyright © 2017 Univ ersity of Wisconsin Hospitals and Clinics Authority
Contact: Lee Vermeulen, CCKM@uwhealth.org Last Revised: 03/2017CCKM@uwhealth.org

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CPG Contact for Content:
Name: Margaret Murray, DNP – Department of Cardiothoracic Surgery
Phone Number: 608-262-0773
Email Address: ma.murray@hosp.wisc.edu

CPG Contact for Changes:
Name: Lindsey Spencer, MS- Center for Clinical Knowledge Management (CCKM)
Phone Number: (608) 890-6403
Email Address: lspencer2@uwhealth.org

Coordinating Team Members:
Takushi Kohmoto, MD, PhD- Department of Cardiothoracic Surgery
Shahab Akhter, MD- Department of Cardiothoracic Surgery
Lindsay Morris, APNP- Department of Cardiothoracic Surgery
Erika Fehrenbach-Prell, APNP- Department of Cardiothoracic Surgery
Maryl Johnson, MD- Department of Cardiology
John Blabaum, APNP- Department of Cardiology
Renee Churchill, APNP- Department of Cardiology
Anna Young, CCP- Department of Surgery- Perfusion
Han-Sen Sun, CCP- Department of Surgery-Perfusion
Thomas Steffens, CCP- Department of Surgery-Perfusion

Review Individuals/Bodies:
Takushi Kohmoto, MD, PhD- Department of Cardiothoracic Surgery
Shahab Akhter, MD- Department of Cardiothoracic Surgery
Maryl Johnson, MD- Department of Cardiology
John Blabaum, APNP- Department of Cardiology
Margaret Murray, DNP- Department of Cardiothoracic Surgery
Lindsay Morris, APNP- Department of Cardiothoracic Surgery
Peter Rahko, MD- Department of Cardiology
Anne Rose, PharmD- Department of Pharmacy
Jennifer Schroeder, MSSW, APSW
Ravi Dhingra, MD- Department of Cardiology

Committee Approvals/Dates:
Inpatient Anticoagulation Committee (02/08/2016)
ξ Interim revisions (06/2016)

Clinical Knowledge Management (CKM) Council (Last Periodic Review: 04/01/2016)
ξ Interim revisions (03/23/2017)

Release Date: March 2017

Next Review Date: April 2018
Copyright © 2017 Univ ersity of Wisconsin Hospitals and Clinics Authority
Contact: Lee Vermeulen, CCKM@uwhealth.org Last Revised: 03/2017CCKM@uwhealth.org

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Executive Summary
Guideline Overview
This guideline is intended to provide evidence individualized, quality and safe patient care. This
guideline is based on an external guideline published in 2013. Some modifications from the
external guideline were made due to meet our hospital’s and patient’s needs.

Companion Documents
1. Device specific handbooks, alarm guides, and troubleshooting guides are available on the
Ventricular Assist Device (VAD) Internal Webpage
2. VAD Assessment Algorithm in the Emergency Department
3. UW Health Periprocedural and Regional Anesthesia Management with Antithrombotic
Therapy – Adult – Inpatient/Ambulatory Guideline
Scope
Disease/Condition(s):
 Advanced heart failure
 Coronary artery disease
 Ventricular assist device/mechanical
circulatory device
 Myocardial Infarction
 Myocarditis
 Cardiac Surgery
 Cardiogenic shock- all causes
 Valvular disease

Clinical Specialty: Cardiology, Cardiac Surgery and Transplant, Nursing, Pharmacy, Providers

Intended Users: Cardiothoracic surgery unit staff, operating room, first day surgery, PACU,
cardiology clinic, cardiology ICU/general care units, echo lab, radiology, cath lab, diabetes
management, heart failure team, biomedical engineering, anesthesia, perfusion, consult
services, , physical therapy, occupational therapy, cardiac rehab, inpatient rehab unit, GI
procedures, emergency department, and pharmacists

CPG objective(s): To provide an evidence-based guideline for inpatient and outpatient
management of patients with mechanical circulatory device (MCD) (formerly ventricular assist
device (VAD)) therapy intended for bridge to transplant, destination therapy, or bridge to
recovery for advanced heart failure for University of Wisconsin Hospital and Clinics.

Target Population: This guideline focuses on all adult patients with MCD (for guidance of
management in inpatient and outpatient settings at the University of Wisconsin Hospital and
Clinics system.

Interventions and Practices Considered:
 Pre-MCD Assessment
 Intraoperative Management
 Postoperative Management
 Outpatient Management
 HeartMate II
 Heartware HVAD
 Thoratec TLC-II and Dual Drive Console
 Total Artificial Heart (TAH)
 CentriMag
 Guidelines for inpatient rehabilitation
 Specific Adverse Events and their
Management
 Maintenance of Equipment

Major Outcomes Considered:
Provide evidence based individualized, quality and safe care to our patients on MCD.
Copyright © 2017 Univ ersity of Wisconsin Hospitals and Clinics Authority
Contact: Lee Vermeulen, CCKM@uwhealth.org Last Revised: 03/2017CCKM@uwhealth.org

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Methodology
Methods Used to Collect/Select the Evidence:
 Hand-searches of Published Literature (Primary Sources)
 Hand-searches of Published Literature (Secondary Sources)
 Hand searches of selected articles’ reference list
 Searches of Electronic Databases
 Hand-searches of manufacturer’s manuals of Indications for Use and Patient
 Handbooks, electronic media
 Hand search of topics from appropriate national or international conferences and research.

The guideline recommendations are based on a 2013 national guideline for preVAD,
intraoperative and postoperative management. In addition, there is a separate HeartMate II
guideline. There are national guidelines for use of MCD (formerly VADs) in patients with
advanced heart failure and appropriate selection criteria. Finally, we follow recommendations
from the device manufacturers. The care for these patients is primarily based on expert opinion,
single center specific research studies and guidelines adopted from national heart failure
guidelines.

Methods Used to Assess the Quality and Strength of the Evidence:
Weighting according to a rating scheme

Methods Used to Assess the Quality and Strength of the Evidence: We reviewed the
national guideline for MCDs, current evidence in managing total artificial heart patients and
recent research on best practice in caring for MCD patients. Review of nursing literature and its
evidence on quality of life of these patients. Review of manufacturer’s recommendations and
conference reported results.

Rating Scheme for the Strength of the Evidence (American Heart Association Evidence Based
Scoring System, Circulation 2006, 114:1761-1791):
Class Definition
A Data derived from multiple randomized clinical trials
B Data derived from a single randomized trial or nonrandomized studies
C Consensus opinion of experts

Methods Used to Analyze the Evidence: Research presented at conferences were reviewed
and discussed for application to the care provided to our patients. Device company
recommendations were implemented to assure the safest care was provided to the patient.
National guideline was analyzed based on expert opinion.

Methods Used to Formulate the Recommendations: We reviewed the national guideline for
MCDs and recent research on best practice in caring for MCD patients. Review of nursing
literature and its evidence on quality of life of these patients. Review of manufacturer’s
recommendations and conference reported results.

Rating Scheme for the Strength of the Recommendations:
 Class I: Conditions for which there is evidence and/or general agreement that a given
procedure or treatment is beneficial, useful, and effective.
 Class II: Conditions for which there is conflicting evidence and/or a divergence of opinion
about the usefulness/efficacy of a procedure or treatment
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 Class IIa: Weight of evidence/opinion is in favor of usefulness/efficacy.
 Class IIb: Usefulness/efficacy is less well established by evidence/opinion.
 Class III: Conditions for which there is evidence and/or general agreement that a
procedure/treatment is not effective and in some cases may be harmful.

Cost Analysis: We did not perform a formal cost analysis nor did we review published cost
analyses.

Definitions: Ventricular assist device (VAD) therapy or mechanical circulatory system device
(MCSD) are systems including heart pump, computer and power to support the failing
myocardium. MCD (formerly VADs) can be implanted surgically or placed percutaneously
depending on the device. It covers right ventricular (RVAD) support, left ventricular (LVAD)
support and biventricular (BiVAD) support. In addition, it covers the utilization of the total
artificial heart system which replaces the patient’s native ventricles.
Introduction
This guideline provides information to those health care providers who may care for patients
with mechanical circulatory devices (MCD) within the University of Wisconsin Hospital and
Clinics system.
Recommendations

Pre-MCD Assessment (UW Health Class I; Level C)
1. All MCD patients with scheduled procedures will have the workup consent (unless
patient conditions prevent this), surgical OR consent, signed prior to going to the
OR. All potential MCD patients and their families will have reviewed the workup
consent including patient and support expectations. (UW Health Class I; Level C)
2. Patients will have the following assessed as part of their MCS evaluation unless
patient condition does not allow to complete testing.
A. Patients will have their transplant candidacy assessed prior to MCS
implantation if the patient’s condition allows. (UW Health Class I; Level A)
B. Patients will have their NYHA functional class and INTERMACS category
assessed and documented. (UW Health Class I; Level C)
C. All patients will have a preop echocardiography. (UW Health Class I; Level C)
D. All patients should have invasive assessment of intracardiac filling pressures
prior to MCSD implantation, with a particular emphasis on RV hemodynamics.
(UW Health Class I; Level C)
E. Patients with have carotid Dopplers if they have vascular disease, coronary
artery disease, ischemic cardiomyopathy, history of stroke or TIA, age > 60 or
bruit. (UW Health Class I; Level C)
F. House inspection of key elements (power, trip hazards and outlets) will be
assessed preop if patient condition allows. If it is not assessed preop, it will
be assessed postoperatively. (UW Health Class I; Level C)
G. All patients should have a screen for psychosocial risk factors prior to MCS.
Family, social and emotional support must be assessed prior to MCS. (UW
Health Class I; Level C)
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H. Quality of life surveys will be done on patients except in urgent implants.
Tools will be in concordance with INTERMACS requirements. (UW Health Class
I; Level C)
I. All patients should have an evaluation by a nutritional consult. (UW Health Class
I; Level C)
J. Patients with known atherosclerotic vascular disease, age > 65, or who have
significant risk factors should be screened for peripheral vascular disease
prior to MCS implant. (UW Health Class IIa; Level C)
K. Patients with prior cardiac surgery or thoracic abnormalities should have a
radiologic exam with CT or MRI prior to MCSD implantation within 1 year of
MCSD implant. (UW Health Class I; Level C)
L. Patients with a history of significant psychiatric illness who are considered for
MCS should have health psychology consult if clinically indicated by social
worker or member of MCD team. (UW Health Class I; Level C)
3. Diabetes or elevated fasting glucose management:
A. Diabetics will have their fasting blood glucose and/or hemoglobin A1C
assessed preoperatively. (UW Health Class I; Level B)
4. In non urgent situations, the following must occur before the device is implanted in
order to evaluate if the patient is an appropriate candidate for MCD therapy.
A. Meet with the heart failure social worker to evaluate the following:
 Social support system
1. Assess strength, weakness and depth of the patient’s social
network (primary and secondary if possible). (UW Health Class I;
Level B)
 Community resources and providers (UW Health Class IIa; Level C)
 Plan for post MCD assistance including Madison-area housing (if
applicable) and 24 hour caregiver coverage post-discharge (UW Health
Class IIa; Level C)
 Transportation (UW Health Class IIa; Level C)
 Education history (UW Health Class IIa; Level C)
 Advance Directives (Power of-Attorney for Healthcare, Living Will) (UW
Health Class IIa; Level C)
 Cultural and Spiritual Issues (UW Health Class IIa; Level C)
 Financial Issues (Work history, disability status, insurance coverage,
medication coverage, veteran status) (UW Health Class IIa; Level C)
 Other current stressors (UW Health Class IIa; Level C)
 Mental health history (UW Health Class IIa; Level C)
 Coping skills (UW Health Class IIa; Level C)
 Stress Reduction Tools (UW Health Class IIa; Level C)
 History of adherence to medical plan (UW Health Class IIa; Level C)
 Substance abuse history (UW Health Class IIa; Level C)
 Legal issues (UW Health Class IIa; Level C)
 Patient/family concerns and expectations related to MCD (UW Health
Class IIa; Level C)
 Housing (UW Health Class IIa; Level C)
 Abuse/Neglect (UW Health Class IIa; Level C)
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B. Meet with the MCD Coordinator to discuss and evaluate the following (all UW
Health Class IIa; Level C):
 Patient must be able to be the primary learner if possible
 Physiology of heart and theory of MCD function that are being
considered for that particular patient
 Ability to manage equipment including batteries, battery charger
controller
 Daily care needed for the MCD
 Driveline site care including sterile dressing change
 Importance of identifying a primary and secondary support person.
Identifying any other support persons who may want to learn
emergency care of the device
 Driving: No driving will be allowed postoperatively until patient has
recovered from surgery. Decision of whether and when patient can
drive safely, will be determined in discussion with the
surgeon/physician team.
 Showering- after surgical healing and provider approval
 Activity restrictions and physical limitations and their timeframes
 Expectations of follow-up frequency after discharge
 Being discharged to hotel in Madison before going home if lives > 1
hour away. Need to stay 24-48 hours
 Minimum 24 hour care needed for the early post discharge period
(daily supervision for the first 2 weeks at minimum based on patient’s
recovery)
 Assess any learning barriers Expectations for teaching requirements
while in the hospital (teaching sessions) At least one additional family
member/friend will be trained as the secondary learner for MCD needs.
This should be identified prior to MCD placement if possible.
Educational sessions will utilize demo equipment, written and verbal
instruction.
 Understanding the importance of being the “expert” on their device
 Cardiac rehab or physical therapy (as appropriate)
 Show demo pumps and equipment if patient expresses desire to view
them
 Power: Home environment concerns such as stairs, grounded outlets
or other concerns
 Medications required for each device
C. Meet with the surgeon (all UW Health Class IIa; Level C)
 Review past medical and surgical history
 Indications for potential MCD
 Review any appropriate diagnostic test to identify any potential issue
with doing the surgery (i.e. echocardiograms, cardiac catheterization
reports, previous surgical reports, chest CTs)
 Discuss with the patient and family: risks, benefits and viable
alternatives to the surgery including complications
 Ability to tolerate the surgery
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 Determine which device is appropriate
D. Heart Failure Team (all UW Health Class IIa; Level C)
 Complete history and physical exam
 Review of lab data, recent echocardiogram, most recent cardiac
catheterization data, cardiopulmonary exercise tests if patient able to
perform
 Assessment of whether any further testing is required to determine if
MCD is best option for the patient
 Optimization of medical therapy (including consideration of bi-
ventricular pacemaker if not already implanted)
E. Financial Coordinator will assess the patient’s insurance for approval for any
of these devices (all UW Health Class IIa; Level C)
F. Consultation to Palliative Care: Patients are identified and referred when
indicated. Patients receive palliative care services when indicated or
requested. (UW Health Class I; Level C)
G. The multidisciplinary team will meet after all recommendations are made to
discuss any issues regarding candidacy. Then, the team will make the
decision whether to implant or not implant. (all UW Health Class IIa; Level C)
H. If clinically indicated, Meet with the health psychologist who will
evaluate/review the following with the patient (all UW Health Class IIa; Level C):
 Medical and treatment compliance history
 Ability to provide informed consent (knowledge/appreciation of risks
and benefits, medical/surgical options, quality of life issues,
treatment/surgical logistics, treatment regimen, device
operation/management, etc.)
 Decision-making ability and process
 Ability to comply with post-surgical treatment regimen and lifestyle
changes
 Social history and social support availability
 Cognitive function screen
 Developmental history
 Personality and psychosocial assessment
 Psychiatric history
 Substance history
I. Appropriateness of primary social support person
Indication/ Contraindication for Destination Therapy (UW Health Class 1; Level B)
1. Destination Therapy Indications:
A. Patients with New York Heart Association Functional Classification Class IV
heart failure symptoms who have failed to respond to optimal medical
management.
B. Patients with a demonstrated functional limitation with a peak oxygen
consumption of less than or equal to 14ml/kg/min if patient is able to perform
a cardiopulmonary exercise test.
C. Patient with a continued need for intravenous inotropic therapy.
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D. Patients who have been evaluated for heart transplant and were not selected
as candidates.
E. Patient will have an anticipated survival benefit.
2. Destination Therapy Contraindications:
 Other life limiting illnesses or end organ insufficiencies felt to be
secondary to causes other than heart failure (UW Health Class III; Level C)
 Patients with acute valvular bacterioendcarditis with bacteremia (UW
Health Class I; Level C)
 Patients with infected implantable defibrillator/pacemaker lead with
bacteremia (UW Health Class III; Level C)
 Patients with permanent dialysis with no suitable mode of dialysis
identified or local center who cannot care for them (UW Health Class III;
Level C)
 An LVAD alone in the setting of an unrepairable ventricular septal
defect or free wall rupture is not recommended. (UW Health Class III; Level
C)
 MCS therapy in pregnant patient is not recommended (UW Health Class
III; Level C)
 Patients who are unable to physically operate their pump or respond to
device alarms, inability to report signs and symptoms of device
malfunction or other health care needs to the MCS team or patients
who live in an unsafe environment are all contraindications to
implantation. (UW Health Class III; Level C)
 Patients with active psychiatric illness that requires long-term
institutionalization or patients who are unable to care for or maintain
their device. (UW Health Class III; Level C)
 Lack of sufficient social support and limited coping skills are relative
contraindications to MCS in patients with a history of non-adherent
behavior. (UW Health Class IIa; Level C)
 Poor compliance with medical regimens is a risk factor for poor
outcomes related to MCS. Patients who demonstrate an inability to
comply with medical recommendations on multiple occasions should
not receive MCS therapy. (UW Health Class III; Level C)
Indication Criteria for Bridge to Transplant (UW Health Class I; Level B)
1. Indications for Bridge to Transplant LVAD placement may include the approved
indications for transplant candidacy:
A. Endstage heart disease unresponsive to conventional cardiac operation or to
medical management:
 New York Heart Association class III or class IV heart failure despite
appropriate medical management and based on patient’s body size
and blood type suggest that the wait for a donor organ will be
prolonged, or
 Endstage ischemic disease which cannot be revascularized in patients
with severe LV function, or

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 Life threatening arrhythmias which are intractable to medical or
surgical therapy complicated by severe LV function, or
 Cardiogenic shock without reasonable chance for improvement,
 Advanced heart failure complicated by renal or hepatic dysfunction
which is felt to be secondary to poor perfusion or congestion
 Severe LV dysfunction complicated by elevated pulmonary pressures
not responsive to conventional agents or when agents cannot be used
or optimized due to low cardiac output and systemic hypotension
 Advanced heart failure complicated by cardiac cachexia
B. Estimated life expectancy of less than 24 months
C. Age less than 70. Exceptional patients age >70 will be considered on an
individual basis.
D. Good family and social support
2. Relative and absolute contraindications for heart transplantation:
A. Pulmonary hypertension
 pulmonary vascular resistance in excess of 6 wood units with
vasodilator challenge
 pulmonary artery systolic pressure of 70 mmHg or greater with
vasodilator challenge
B. Advanced pulmonary disease
C. Active, untreated peptic ulcer disease
D. Current alcohol, tobacco, or substance abuse
E. Chronic systemic illnesses which may compromise recovery
F. Current or recent malignant neoplasm
G. Diabetes mellitus which is difficult to control or which has caused non-cardiac
end-organ damage
H. Advanced cerebrovascular disease
I. Neuropsychiatric disability
J. Obesity, defined as weight greater than 140% of ideal body weight or BMI
greater than 35 kg/m2
K. Severe cachexia <75% ideal body weight
L. Active systemic infection
M. Severe, irreversible hepatic dysfunction (not from cardiac failure)
N. Symptomatic lower extremity arterial disease.
O. Evidence of patient non-compliance.
P. Pulmonary infarction within the last three months.
3. Patient Compliance (UW Health Class I; Level C):
A. If patient is active on the transplant list and exhibits non-compliance, he/she
will be made status 7. Based on the team’s decision, he/she may be removed
from the heart transplant waiting list.
B. Non-compliance with care will be dealt with on an individual basis. Plan of
care will be re-evaluated for patients who are exhibiting signs of non-
compliance and addressed by the multidisciplinary team.

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PreMCD Surgery Preparation:
1. Preoperative Labs:
A. Preop labs will consist of electrolytes, calcium, phosphate, BUN, creatinine,
fasting blood glucose, magnesium, prealbumin, C reactive protein, albumin,
liver function tests (alkaline phosphatase, ALT, AST, t. bilirubin, LD), total
protein, hemoglobin A1C, for diabetics, coagulation tests (INR, PTT), and
CBC with differential. Patient will have urinalysis and blood cultures drawn as
condition allows. Patients will have nasal screens for MRSA and receive
topical treatment prior to MCS implantation if positive. (UW Health Class I; Level C)
2. Medications:
A. Antibiotics: Preoperative antibiotics include should include broad-spectrum
gram-positive and gram-negative. (UW Health Class I; Level C)
B. Antiplatelet: Thienopyridine anti-platelet agents should be stopped at least 5-
7 days prior to surgery unless there is a compelling indication for continued
use (UW Health Class IIa; Level C)
 http://www.uwhealth.org/files/uwhealth/docs/anticoagulation/Periproce
dural_Anticoagulation_Guideline.pdf
C. Intravenous lines: All patients should have all unnecessary lines and
catheters removed prior to MCSD implantation. (UW Health Class I; Level C)
Intra-Operative Management
1. Antibiotic: Routine antibiotic prophylaxis is administered 1 hour within first incision
and lasting up to 48 hours postoperatively. (UW Health Class I; Level C)
2. Anesthesia Management
A. Patients undergoing MCSD placement should have insertion of a large-bore
intravenous line, arterial line and pulmonary artery catheter to allow for
continuous monitoring and intravascular access (except for biventricular or
total artificial heart support). (UW Health Class I; Level B)
B. Cardiac anesthesia should be performed by those familiar with the clinical
issues associated with MCSD placement, including considerations at the time
of induction, during surgery, during separation from cardiopulmonary bypass
and at the time the MCAD is actuated. (UW Health Class I; Level B)
C. Intraoperative transesophageal echocardiography should be performed by
physicians with advanced training in the intraoperative assessment of cardiac
structure and function. (UW Health Class I; Level B)
3. Implantation Techniques
A. An LVAD alone in the setting of an unrepairable ventricular septal defect or
free wall rupture is not recommended. (UW Health Class III; Level C)





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Postop Guidelines (Applicable to all Devices)
(Rose et.al. 2001; Hunt et. al., 2001, Riechenbacher et. al. 2003 ; Slaughter et.al., 2010 ; Feldman et.al., 2013)
1. General Care of the Patient (UW Health Class IIb; Level C)
A. Blood products: Leukopoor filters/leukopoor blood will be transfused for these
patients.
B. Only trained personnel in MCD therapy will be allowed to adjust MCD
settings. Attending [surgeon, heart failure/transplant cardiologist, CTICU), or
MCD advanced practice provider [APP]) approve any changes to VAD
readings.
C. Staff will assess for proper MCD functioning at all times.
D. A backup MCD console/ controller/ batteries/ clips/ cables will be kept
accessible on unit or in the patient’s room. See specific device section of this
guideline for backup devices procedures.
E. If the patient warrants change out of a piece of equipment, perfusionist,
surgeon, MCD coordinator or experience trained MCD RN will supervise the
equipment being changed out. See specific device section of this guideline
for change out procedures.
F. The emergency device failure equipment will be immediately available at all
times. Emergency care including defibrillation and device failure procedures
are specific per device. Please refer to device specific section of guideline or
manufacturer’s device manual for specific instructions.
G. No Magnetic Resonance Imaging (MRI’s) will be ordered; chest radiographs,
computed tomography (CT scans) and fluoroscopic procedures are
acceptable.
H. Blood pressure control: For pulsatile MCD, maintain patient’s SBP < 130
mmHg and DBP < 85mmHg or as prescribed by the provider. For non-
pulsatile MCD, MAP should be < 80mmHg or per provider orders
I. For all MCD patients), skin integrity will be monitored closely. Precautions to
promote skin integrity per UWHC guidelines will be initiated.
J. Consults to pastoral services, health psychology or psychiatry will be provided
on an individual basis.
2. Echocardiography: Used to determine speed on continuous flow devices. Adequate
LV unloading is demonstrated by intermittent aortic valve opening, LV septum
midline and minimizing mitral regurgitation. (UW Health Class I; Level C)
3. Preferred heart failure medications are: ACE inhibitor, ARB, beta blocker,
hydralazine and nitrates for blood pressure management. (UW Health Class I; Level C)
4. Management of Certain Situations
A. Hypotension Management: A systematic approach to hypotension should be
utilized. (UW Health Class I; Level C)
B. Right Ventricular dysfunction
 May need to continue inotropes for more than 2 weeks for patients who
exhibit elevated jugular venous pressure, signs of venous congestion,
decreased MCD flows (low pulsatility if applicable) or end-organ
dysfunction. (UW Health Class I; Level C)
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13

 Wean cautiously when patient has euvolemia and monitor for
reoccurrence of RV failure signs and symptoms. (UW Health Class I; Level
C)
 Diuretics and renal replacement therapy should be used early and
continued as needed to maintain optimal volume status. (UW Health
Class I; Level C)
 Phosphodiesterase inhibitor should be considered for patients with
persistent pulmonary hypertension with signs of RV dysfunction. (UW
Health Class I; Level C)
 May use pacemaker therapy to increase heart rate if it is not optimal to
support the patient’s hemodynamics. (UW Health Class IIb; Level C)
 Monitor for changes in LVAD parameters including decrease flows and
pulsatility in the setting of RV failure. (UW Health Class I, Level C)
 Patients may need to be readmitted for inotropes if signs and
symptoms of RV failure persist. (UW Health Class I; Level C)
 Right heart catheterization may be useful in the assessment of
persistent or recurrent heart failure symptoms after MCSD placement
and to evaluate for evidence of RV failure or device malfunction at
regular intervals for BTT patients with persistent pulmonary
hypertension or increased PVR after MCD implantation. (UW Health
Class I; Level B)
5. Anticoagulation and Anti-platelet (UW Health Class IIb; Level B)
A. Start warfarin on POD#2-3 or per surgeon’s discretion.
B. Target INR can be modified based on each individual’s condition,
postoperative course, past medical history and device type. Minimum INR of
2 should be achieved unless otherwise indicated.
C. Heparin drip may be started within 12-24 hours postop at the surgeon’s
discretion and based on clinical indicators.
D. Heparin drip therapeutic goals are listed in CPG. The most common goal is
anti-X 0.3-0.7 but is based on device and bleeding risk..
E. Aspirin starts POD #1. Dose determined based on device type, perioperative
bleeding and surgeon decision.
6. Invasive Lines and Tubes (all UW Health Class I; Level C):
A. Chest tubes:
 Removal chest tubes on POD 2 or when drainage < 100ml in previous
6 hours
 Removal pocket drains on POD 3 or when drainage < 100ml in
previous 6 hours
B. PA catheter: Remove within 24-48 hours unless severe right heart failure for
weaning of inotropes
C. Arterial line: Remove within 48-72 hours unless patient remains on vasoactive
drips
7. Special equipment instructions
A. Never disconnect both power sources simultaneously; this will stop the pump.
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14

B. Do not expose controller to moisture/liquids/water due to risk of electrical
shock.
C. Do not drop controller on the floor/other hard surfaces; this may damage
controller and may stop pump
D. All connectors should be handled with care and kept free of liquid, dust, or
debris. Avoid twisting patient cables from outlet to controller or from
console/power module to controller.
E. Do not disconnect controller/ console from pump; pump will stop.
F. For any issues related to equipment (failure, malfunction, backup mode of the
MCD is in use) refer to UWHC policy 8.39AP Repair or Replacement of
Essential Equipment in Case of Breakdown. If the equipment malfunction
causes injury to patient, follow policy 1.18 Patient injuries – equipment
related. The manufacturer and UWHC biomedical engineering will be notified
with any problems or concerns with these devices.
G. Maintenance will be done based on manufacturer’s timetable and by trained
staff.
H. In the hospital, all consoles connected to patients will be plugged into a red
backup generator outlet.
8. Nursing Care
A. Dressing change will be documented on the appropriate device specific
flowsheet. (UW Health Class I; Level C)
B. Daily dressing care per the following protocol (applies to HeartMate II,
Thoratec, Heartware HVAD, Total Artificial Heart and CentriMag [with a
closed chest]). (UW Health Class I; Level C)
 Use of sterile technique for all approaches to driveline dressing change
 Nurse and/or family member performing dressing change will wear a
mask Patient must wear a mask.
 Check drive line site for signs of infection with every dressing change.
With every dressing change, the site will be assessed for any signs of
infection: redness, tenderness, change in drainage color or
consistency, new drainage, swelling or erythema. Surgeon or MCD
coordinator will be notified of any of these signs or symptoms.
 Driveline will be immobilized using centurion Foley anchor unless pt’s
skin does not tolerate or per surgeon’s direction. (UW Health Class I; Level
C)
 3 methods of dressing change:
Which patients? Method type Frequency Supplies
All new implants or driveline
infection with drainage Daily (with kit) Daily
Enclosed in kit CS #
4015108
Patient > 4 weeks out; no
drainage
Twice a week Every 3
days
Enclosed in kit CS #
4015109
Per surgeon discretion or
patients who used this process
before dressing kit switch
Traditional Daily
See outline of
dressing process
below
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15

 Daily Driveline Dressing kit will be utilized for all new patients
postoperatively until surgeon determines they can switch to 2x/week
dressing kit. https://uconnect.wisc.edu/clinical/nursing-hub/mechanical-
circulatory-device-vad/dressing-guidelines/
 Twice per week driveline dressing will be utilized on patients as
determined by the surgeon or MCD NP. Follow the instructions in the
kit. https://uconnect.wisc.edu/clinical/nursing-hub/mechanical-
circulatory-device-vad/dressing-guidelines/
 Process for Driveline Dressing if Surgeon deems appropriate
(https://uconnect.wisc.edu/clinical/nursing-hub/mechanical-circulatory-
device-vad/dressing-guidelines/):
i. Wash hands. Mask for nurse, patient and family member during
dressing change process.
ii. Put on non-sterile gloves. Old dressing will be removed with
clean technique and using non-sterile gloves. Wash hands.
Open up supplies.
iii. Hibiclens diluted with diluted sterile saline used to clean the exit
driveline site and then dry with sterile 4x4’s Sterile gloves
exchanged
iv. Split drain sponges will be applied around entry sites and then
covered with sterile 4x4’s. Abdominal pad placed over 4x4’s if
patient’s driveline exit site has moderate to large amount of
drainage.
v. Dressing will be secured with Medipore tape to prevent skin
irritation
 The following will not be used near the driveline:
i. Acetone (adhesive remover, model airplane glue, nail polish
remover, skin prep, certain cleaning agents, paint thinner) due
to potential damage to driveline
ii. Povidine- iodine ointment/Silvadene cream due to prevention of
tissue growth
iii. No petroleum based products due to potential degradation of
cannulas
C. MCD checks are every 1 hour and as needed for 24 hours, then every 2
hours and as needed while in CTICU; then every 4 hours and as needed
while in CT tele/IMC (telemetry/ intermediate care) (UW Health Class I; Level C)
 Normal values for device parameters should be established and
recorded in the electronic medical record with triggers for physician
notification. (UW Health Class I; Level C)
 All MCD readings should be documented in device specific flowsheet
and reported to the appropriate provider.
 Changes in MCD parameters outside of normal ranges should be
thoroughly evaluated and treated appropriately. (UW Health Class I; Level
C)
 Depending on the type of MCD, any changes in MCD readings
or trends will be documented in the patient’s clinical record. Attending
heart surgeon, heart failure cardiologists, MCD program advanced
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16

practice provider, and MCD coordinator (in consultation with one of the
aforementioned providers) can make the decision to change the MCD
settings based on recent trends.
D. Physical limitations (applies to HeartMate II, Heartware HVAD, Total Artificial
Heart and Thoratec)
 Sternal precautions should be followed for 4-8 weeks based on
attending surgeon order
 Sleeping/napping: patient should be plugged into constant electrical
source so the pump does not lose power if the batteries drain
completely
 Do not pull patient’s arms to position patient.
 Gait belt position may be used but avoid constricting driveline
9. Patients will be assessed for any psychiatric symptoms. (all UW Health Class I; Level B)
A. If these symptoms develop, consults to health psychology, social work or
psychiatry may be initiated. Provide:
 Emotional support to patient and family
 Reinforcement for the patient and family on teaching points
 Individualistic care
10. Showering: MCD coordinator will educate the patient and family on how to use the
device specific shower kit prior to patient being able to shower. Initially post surgical
recovery, MCD patients may shower once approved by the attending surgeon. If
patient needs more physical recovery and teaching on the use of the shower kit,
MCD APP can approve patient for healing. Outpatient MCD patients can shower
once approved by the attending physician or MCD APP. MCD coordinator will
educate the patient and family on how to use the device specific shower kit. Patient
is to use the appropriate shower kit for their device and follow the manufacturer's
directions. MCD driveline dressing is to be changed per the instructions above
immediately after the shower.
11. Nutrition will be consulted to provide guidance postop. (UW Health Class I; Level C)
A. If the patient is unable to meet their nutritional goals- enteral feeding will be
started unless it is not tolerated. Then parenteral nutrition will be used. (UW
Health Class I; Level C)
12. Patient and family education:
A. Patient and family members should be taught to track their device parameters
and alert staff when changes are observed. (UW Health Class I; Level C)
13. Off Unit Procedures for Inpatient MCD patients (UW Health Class II; Level C)
A. Trained personnel will accompany these patients off the unit for tests or
procedures with appropriate backup equipment in case of device failure.
B. The MCD Coordinator/Cardiac Surgery CNS or CT/CCU RNs will assess and
document family member and patient competency concerning: emergency
procedures, troubleshooting alarms, operation and care. If a patient or family
member has been assessed as competent, the patient may leave the unit
with a family member if there is a physician. The patient must take backup
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17

equipment if appropriate. (See CPG and the pertinent section referring to the
specific devices.) The patient cannot leave the unit or hospital alone.
14. Discharge Needs - Only applies to dischargeable MCD (VADs) (HeartMate II,
Heartware HVAD, Total Artificial Heart with Freedom Driver and Thoratec TLC-II)
A. Community personnel education (UW Health Class I; Level C)
 MCS team will contact and provide information re: VAD physiology and
care to local health providers including cardiac rehab or physical
therapy and referring physicians. Education should focus on MCSD
concepts and associated physiologic changes.
 Patient’s local emergency room and emergency response personnel
will contact and provide information re: VAD physiology and care on
emergency procedures of the MCD by the MCD Coordinator before
patient discharge. Reference materials should be provided to aid
personnel in assessing and triaging the patient. (UW Health Class I; Level C)
 Emergency transport system will be established to expedite transfer to
the implant center in case of emergency. (UW Health Class IIa; Level C)
 Cardiac Rehab or physical therapy will be arranged upon discharge.
The local cardiac rehab or physical therapy department will be
contacted and provided information about VAD physiology, activity
restrictions and emergency procedures by the MCD Coordinator. (UW
Health Class I; Level C)
B. Patient (if not living locally) will be discharged to a hotel in Madison for
anywhere from 2 to 4 days, pending health status and surgeon or heart failure
team approval to go home. This will be determined on a case by case basis
by the attending surgeon, heart failure attending and MCD coordinator.
C. Patient education learning needs are assessed in compliance with UWHC
policy 14.21- Patient and Family Education.
D. Patient and primary family member will verbally pass problem solving
scenarios for troubleshooting all MCD alarms and daily care/maintenance as
administered by the MCD Coordinator prior to initial discharge. (UW Health
Class I; Level C)
E. An uninterrupted supply of electricity to continuously power the MCSD must
be ensured. Patient’s electric company will be notified by MCD Coordinator
to establish medical alert on patient’s account for priority status to resume
electrical power in the event there is loss of power to the home. (UW Health
Class I; Level C)
F. Post-discharge dressing supplies will be arranged by the heart failure social
worker.
15. Specific Potential Adverse Events, Comorbidities and Their Management
A. Gastrointestinal Bleed (First episode) (all UW Health Class I; Level C)
 Patients should be managed in consultation with gastroenterology.
 A colonoscopy or upper endoscopic (EGD) evaluation is
recommended.
 If the colonoscopy or EGD is negative, an examination of small
intestines is warranted in continuous flow devices.
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18

 In the setting of persistent bleeding and a negative endoscopic
evaluation, a capsule study may be considered.
 Once the GI bleeding has resolved, anti-coagulation and anti-platelet
therapy will continue with modifications in dosing or target INR
determined on an individual basis.
B. Gastrointestinal Bleed (Recurrent episode(s)) (UW Health Class I; Level C)
 Repeated endoscopic evaluation should be conducted in consult with
gastroenterology. (UW Health Class I; Level C)
 In the setting of no source found or source not amenable to therapy,
anti-platelet and warfarin therapy should be reevaluated based on GI
bleed severity and device type. Octreotide may be considered also.
(UW Health Class I; Level C)
 Device speed may be decreased due to arteriovenous malformation for
continuous flow pump patients. (UW Health Class I; Level B)
C. Neurological Deficit
 New Neurologic Deficit
i. Assessment of INR at time of neurologic event and also review
of recent INR results. (UW Health Class I; Level B)
ii. Neurology or stroke team should be consulted. (UW Health Class I;
Level B)
iii. Pump parameters should be reviewed for signs of device
thrombosis or malfunction. (UW Health Class I; Level B)
iv. Extracorporeal pump housing should be assessed for clots. (UW
Health Class I; Level C)
v. Discontinuation or reversal of anti-coagulation in the setting
hemorrhagic stroke is recommended. (UW Health Class I; Level B)
vi. Assess for source of thrombus in the setting of an embolic
stroke should be considered. (UW Health Class IIa; Level B)
vii. Radiologic diagnostic tests may be considered for assessment
of embolic strokes. (UW Health Class I; Level C)
viii. Selective use of an interventional radiologic approach to
thrombotic strokes may be considered. (UW Health Class IIb; Level
C) Routine use of interventional radiologic approach to
thrombotic strokes is not recommended. (UW Health Class III; Level
C)
ix. Selective use of thrombolytic agents in the setting of thrombotic
stroke without CT scan evidence of hemorrhage may be
considered. (UW Health Class IIa; Level C) Routine use of
thrombolytics in the setting of thrombotic stroke without head CT
scan evidence of hemorrhage is not recommended (UW Health
Class III; Level C)
 Chronic management of patients after presentation of new neurologic
deficits:
i. Formal stroke rehabilitation is considered based on patient’s
recovery and deficits. (UW Health Class I; Level B)
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19

ii. Close monitoring of anticoagulation in setting of an embolic
stroke to maintain adequate levels is recommended. (UW Health
Class I; Level C)
iii. Long term blood pressure control is recommended. (UW Health
Class I; Level B)
iv. Resumption of anti-coagulation in consultation with neurology or
neurosurgery in the setting of hemorrhagic stroke is
recommended. (UW Health Class I; Level B)
D. Infection Workup
 Diagnostic tests: CBC, C reactive protein, ESR, CXR and blood
cultures may be considered as an initial screen. (UW Health Class I, Level
B)
 Infectious disease consult service may be contacted for patients based
on previous infection history, comorbidities or specific situations. (UW
Health Class I; Level A)
 Two cultures should be drawn with at least 1 culture from any
indwelling central venous catheters (if applicable) and one peripherally.
(UW Health Class I; Level A)
 Aspirate from potential abscesses if clinically warranted. (UW Health
Class I; Level A)
 Radiographic studies should be done based on the symptoms and
examination. (UW Health Class I; Level A)
E. Arrhythmias
 Beta-blockers may be used to control rate in setting of
tachyarrhythmias. (UW Health Class II; Level C)
 Ventricular
i. Patients with incessant ventricular arrhythmias should be
admitted for further management and monitor for hemodynamic
compromise. (UW Health Class I; Level C)
ii. Patients with ventricular arrhythmias refractory to medical
therapy may require catheter ablation performed by
electrophysiologist with knowledge and expertise in MCS
therapy. (UW Health Class I; Level C)
iii. Patients with VT that results in poor device flows and/or
hemodynamic compromise should be cardioverted. (UW Health
Class I; Level C)
iv. The occurrence of VT on MCS should prompt a search for
reversible causes such as electrolyte imbalances or drug
toxicities. (UW Health Class I; Level C)
v. Amiodarone is a reasonable chronic outpatient treatment to
prevent recurrence of VT in patients with MCS. (UW Health Class
IIa; Level C)
vi. Therapy with beta blockade maybe useful in the setting of
recurrent VT. (UW Health Class IIa; Level C)
vii. Recurrent VT in the setting of a continuous flow pump should
prompt consideration of a suction event. (UW Health Class IIa; Level
C)
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20

viii. Patients with biventricular support with VF who are refractory to
therapy but have stable flows may be left in VF with the
defibrillator function of the ICD turned off. (UW Health Class IIb;
Level C)
 Atrial (UW Health Level C)
i. Digoxin may be useful to control rapid ventricular response.
(UW Health Class IIb; Level C)
ii. Cardioversion of atrial fibrillation is recommended in patients
with rapid ventricular rates that compromise device
performance. (UW Health Class I; Level C)
iii. When atrial fibrillation is present and does not interfere with
device functioning, management following the most recent
American College of Cardiology/American Heart Association
atrial fibrillation guidelines is recommended. (UW Health Class IIa;
Level C)
F. ICD/ Pacemaker:
 For patients who have ICD prior to MCS, the ICD should be reactivated
in the post-operative setting. (UW Health Class I; Level A)
 Placement of an ICD may be considered if the patient does not have
an ICD prior to MCS. (UW Health Class IIa; Level B)
 Inactivation of the ICD can be considered for clinical indication. (UW
Health Class IIa; Level C)
G. Non-cardiac OR procedures
 MCS team should be notified of non-cardiac procedure to facilitate
collaboration with MCS and surgical teams. (UW Health Class I; Level C)
 Urgency:
i. Non-urgent: Warfarin and anti-platelet therapy may be
continued if risk of bleeding associated with procedure is low. If
warfarin and anti-platelet needs to be stopped than it should be
done for the appropriate time frame based on the required
procedure. (UW Health Class I; Level C) Refer to the UW Health
Periprocedural and Regional Anesthesia Management with
Antithrombotic Therapy - Adult - Inpatient/Ambulatory Guideline.
ii. Emergency: Warfarin may need to be rapidly reversed with
fresh frozen plasma or prothrombin protein concentrate. (UW
Health Class IIb; Level C) Several low quality studies have
demonstrated the administration of vitamin K and PCC to be
safe in MCD patients, whereas other studies and clinical
experience support the use of fresh frozen plasma.
 Post-procedure, warfarin and anti-platelet may be resumed when risk
of surgical bleeding is deemed acceptable. Patients may be bridged
with heparin or a heparin alternative while waiting for the INR to reach
target range. (UW Health Class I; Level B)
 During minor procedures, blood pressure monitoring with Doppler is
appropriate. (UW Health Class I; Level C)
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21

 During procedures with risk of hemodynamic compromise, an arterial
line for blood pressure monitoring should be placed. (UW Health Class I;
Level B)
 Central venous pressure may be placed for monitoring of central
venous pressure and to administer vasoactive drips in procedures
where hemodynamic compromise is moderate or high risk. (UW Health
Class I; Level C)
 During these non-cardiac procedures, MCSD parameters should be
monitored by expert personnel such as MCS nurses or perfusionists.
(UW Health Class I; Level C)
 Cardiovascular surgeon should be informed of non-cardiac procedure.
(UW Health Class I; Level C)
H. Hemolysis
 Screening for Hemolysis should occur in setting of an unexpected drop
in hemoglobin or hematocrit level or with other clinical signs of
Hemolysis. (UW Health Class I; Level C)
 Hemolysis in the presence of altered pump function should prompt
admission for optimization of anti-coagulation and anti-platelet
management and possible pump exchange. (UW Health Class I; Level B)
 Routine screening for Hemolysis with LD and plasma-free hemoglobin
assessment in addition to hemoglobin or hematocrit should occur
periodically throughout the duration of MCS. (UW Health Class IIa; Level C)
I. Thrombus vs. Hemolysis Algorithm
 Below is suggested guideline for thrombosis and hemolysis
management (Goldstein et.al., 2013). (UW Health Class IIa, Level C)
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22

J. Obesity: Weight loss should be encouraged for all patients with a BMI >
30kg/m2. (UW Health Class IIa; Level C)
K. Device failure and dysfunction (all UW Health Level I; Level C)
 Device failure is a medical emergency and the patient should be
transported back to the MCSD center for treatment.
 Definitive therapy for pump stoppage is pump exchange if patient is
stable enough to undergo reoperation.
 Patients with functional pump but has alarms or changes in MCD
readings that cannot be resolved as an outpatient need to be admitted
to the hospital for further observation and close monitoring.
L. Emergency procedures
 For every alarm, check patient first; then, check controller/console to
assess which alarm is occurring. Reference card at bedside to assist in
assessing alarm(s).
 Pump Stoppage:
i. If the MCD has stopped < 5 minutes, notify heart failure
attending on call (outpatients) or attending surgeon (inpatients)
immediately for further guidance. You should refer to and initiate
device specific guidelines. Then, notify heart failure attending on
call (outpatients) or attending surgeon (inpatients) immediately
for further guidance.
ii. For inpatients: If it is suspected the MCD is off, may consider
administering Heparin 10,000 units IV if none of the following
contraindications are present (Gastrointestinal bleed, Heparin
allergy or Heparin induced thrombocytopenia, INR >3, history of
hemorrhagic stroke or suspected stroke) for MCD failure with <
5 minutes of stoppage and call attending surgeon immediately.
iii. If the pump is off > 5 minutes or unknown length of time, notify
heart failure attending on call (outpatients) or attending surgeon
(inpatients) immediately for further guidance. Do not restart
equipment but refer to device specific instructions.
 See specific device for more information pertaining to emergency care
M. End of Life Issues:
 In situations when there is no consensus about discontinuing MCSD
support, consideration may be given to consulting with the hospital
ethics board. (UW Health Class I; Level C)
 Palliative care may be consulted to assist the patient, family and team
in a particular situation.
16. Care for MCD Patients going to the Operating Room/ First Day Surgery



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23

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24

Outpatient Management
(Grady et. al., 2001, 2004; Banning and Houghton, 2005; Feldman et.al. 2013; Akhter et.al., 2015; Hernandez et. al, 2015)
1. Patients will follow-up clinic visit after 2 or 3 days at the hotel or per the discretion of
the patient’s attending. At this clinic visit with the MCD Coordinator/NP or Heart
Failure nurse practitioner, patient will be assessed to determine if they are ready to
return home from both a medical standpoint and psychosocial standpoint of
managing the MCD. (UW Health Class I; Level B)
2. Patient may be seen in follow-up at the following intervals (UW Health Class I; Level B):
A. Every one to two weeks for the first month
B. Once per month for the next 2 to 6 months
C. After six months if the patient is stable, may be seen every 6 to 12 weeks
D. If patient's condition changes, clinic visits are scheduled more frequently
3. The follow-up visits may alternate between the MCD NP and the Heart failure
physician based on schedule availability.
4. The surgeon will follow-up with the patient at the 4 week visit or as patient indicated.
5. At the follow-up visits, the following should occur (UW Health Class I; Level B):
A. The MCD Coordinator will assess the driveline exit site. The driveline
dressing may be changed as needed. Appropriate intervention will be
initiated if needed for suspicion of infection. Driveline immobilization will be
reinforced at each clinic visit. (UW Health Class I; Level C)
B. Driveline itself will be palpated to assess for changes in tactile assessment
(i.e. kinks, bends, and nicks). Driveline connection to the controller will be
assessed for any defects. (UW Health Class I; Level C)
C. The MCD Coordinator will assess the MCD numbers and trends for any signs
of pump hemolysis. Patients are instructed to bring in their MCD tracking
sheets to clinic visits. Pump parameters will be adjusted accordingly to
optimize pump function. (UW Health Class I; Level C)
D. Alarm history and log files (if applicable) should be obtained at regular
intervals and sent to the appropriate device company specialists. (UW Health
Class I; Level C)
E. The patient should be asked about any MCD alarms and how they feel they
are managing the device.
F. When approved by the surgeon or MCD APP, patient will be trained in using
shower kit. (UW Health Class I; Level C)
G. Reinforcement of any education, alarm troubleshooting and assessment of
patient/family adjustment will be done at every clinic visit. (UW Health Class I;
Level C)
H. Ongoing refreshers may be provided to patients and caregivers on alarm
troubleshooting, managing what if scenarios and emergency procedures. (UW
Health Class I; Level C)
6. Transthoracic Echocardiograms (TTE) (all UW Health Class I; Level B)
A. Echo sonographers will follow UW echo protocol.
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25

B. Should be obtained at the following intervals unless otherwise indicated by
ordering the provider:
 One month post-op
 Three month post-op
 Six month post-op
 12 months
 Based on patient condition
C. Echocardiography can be used for setting optimal pump parameters.
D. Echocardiography can be used to evaluate sub-optimal MCSD function or in
the presence of clinical signs of circulatory dysfunction including congestive
or low output symptoms.
E. RAMP study may be done for patients with concerns for a suspected clot
inside the pump.
7. Six minute walk for functional capacity assessment if patient is able. (all UW Health
Class I; Level B) All timeframes are post surgery.
A. Prior to discharge from the hospital
B. 3 months
C. 6 months
D. 12 months
E. Every 6 months after 12 months
8. Health related QOL (UW Health Class IIb; Level B) and neurocognitive assessment (UW
Health Class IIa; Level C) will be conducted at the following time points:
A. Will attempt to obtain this presurgery
B. 3 months
C. 6 months
D. 12 months and every 6 months after
9. MCD Patients in Outpatient
A. Outpatient: diagnostic tests and procedures:
 Without moderate sedation: MCD patients will go for diagnostic tests
unaccompanied by the MCD Coordinator if the procedure does not
require moderate sedation. If Radiology or procedure area requests
presence of a team member for a diagnostic test, then one will be
present. Pager numbers for the MCD Coordinator/surgeon are made
available for any questions or concerns.
 With moderate sedation: Procedures with moderate sedation or non-
sedation procedures as deemed necessary by the medical team, a
MCD coordinator will be present for the procedure.
B. For consulting clinics, a MCD Coordinator may accompany the patient if
requested by the clinic staff.
10. Right heart catheterization (all UW Health Class I; Level A and B):
A. Right heart catheterization may be performed at regular intervals in bridge to
transplant patients with persistent pulmonary hypertension or increased
pulmonary vascular resistance after MCD implantation. (UW Health Class I; Level A)
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26

B. Right heart catheterization may be performed to corroborate evidence of
myocardial recovery. The pulmonary artery catheter may be left in place with
serial lowering of the pump speed to confirm acceptable hemodynamics with
decreasing MCD support prior to pump explant. (UW Health Class IIa; Level C)
11. Medications:
A. Antiplatelet therapy (all UW Health Class I; Level C)
 Anti-platelet therapy will be prescribed based on device manufacturer
recommendations.
B. Diabetes: Patients should have close follow up for their diabetes by their
primary care provider or endocrine specialist. (UW Health Class IIa; Level C)
C. Heart failure therapy (all Class I; Level C)
 Fluid overload management: diuretics
 Blood pressure controller risk reduction in patients with vascular
disease and diabetes- ACE inhibitor or ARB
 Beta blockers maybe used for blood pressure control, rate control in
patients with tachyarrhythmias.
 Mineral corticoid receptor antagonists may be used to limit the need for
potassium repletion in patients with adequate renal function and for
potential beneficial anti-fibrotic effects on the myocardium.
D. Hypertension management. (all Class IIb; Level C) General recommendations are
below. See device specific guidelines as needed.
 Pulsatile pumps: SBP< 130 mmHg or DBP > 85 mmHg
 Non-pulsatile: MAP < 80 mmHg
12. Lab monitoring (all UW Health Class I; Level B)
A. Anticoagulation Management -- If the patient requires warfarin for
anticoagulation, the INRs will be followed by the heart failure team or MCD
APP. Target INR can be modified based on each individual’s condition,
complication (i.e. GI bleed, stroke-embolic or hemorrhagic), surgical operation
and device.
B. Lab studies should be assessed at regular intervals to assess end-organ
function, monitor device-specific issues and diagnose and monitor the status
of comorbid conditions. Appropriate treatment will be determined based on
specific lab tests or trends.
13. Contacts (UW Health Class I; Level C)
A. Patients are instructed to notify the MCD coordinator or MCD APP during
normal business matters with concerns or questions.
B. After hours they are instructed to contact the heart failure attending physician
or MCD Coordinator with urgent matters
C. For emergencies, call 911 and then contact UW MCD team.
D. The MCD coordinator will be contacted by the or attending if there is a
problem is related to the device.
14. Inpatient Admissions (Please see VAD Policy 1.40 for more information)
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A. MCD patients may only be admitted to B4/5 - Cardiothoracic Unit except for
those transferred to inpatient rehabilitation after approval from the rehab
attending.
B. Accepting service will generally be Cardiothoracic surgery or Heart Failure. If
MCD patient is admitted by another service, cardiac surgery or heart failure
service should be consulted.
15. Annually, all current MCD patients will be sent a survey to assess their feedback on
their preparedness for transition to home and patient satisfaction with their care.
The MCS team will review the results of this survey annually and discuss possible
interventions to improve. (UW Health Class IIa; Level C)
16. Patients may have less than 24/7 support if they meet the following two criteria.
First, the patient must be able to independently troubleshoot all alarms and what if
situations. Two, the medical team must agree the patient is ready have less than
24/7 support.
17. Special Situations:
A. Psychological and psychiatric issue
 Patients being considered for MCSD should have a detailed
psychosocial evaluation. (UW Health Class I; Level C)
 Formal consultation with a psychiatrist may be obtained for those with
concerns for psychiatric illness. Appropriate pharmacologic and
psychological therapy should be initiated as needed. Counseling may
need to be extended to include family members as well. (UW Health
Class I; Level C)
B. Patients with MCSD therapy should continue to follow a general health
maintenance schedule, including gender-related and age-specific
recommendations, routine vaccinations and dental care. (UW Health Class I;
Level C)
C. Cardiac Rehabilitation: All patients who are able will be referred to cardiac
rehab post discharge from the hospital after MCS implant surgery. (UW Health
Class II; Level C)
D. Substance abuse:
 Smoking cessation should be encouraged in all patients on MCS who
continue to use tobacco. (UW Health Class I; Level C)
 Alcohol and drug treatment programs will be offered for patients with a
history of substance abuse. (UW Health Class IIa; Level C)
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CentriMag (Thoratec) (all UW Health Class I; Level C)

CentriMag Ventricular Assist System (VAS): Patient & Device Management Guidelines:
http://www.perfusion.com/cgi-bin/absolutenm/articlefiles/3622-PL-
0156_Rev_00_CentriMag_VAS_Patient_and_Device_Management_Guidelines.pdf

1. Equipment and Stated Purpose:
A. Console (weights 6.6kg)
 Features: rpm and flow display
 Menu button
i. Make changes to the speed, flow alarm limits
1. Do NOT make changes of more than 100rpm at one
time; very sensitive to speed changes
ii. Normal speed range is 3000-4000 rpm with about 5L/min of flow
iii. Can set high and low flow settings
iv. If chest is open do not increase rpm to 5000
 Battery charge status
i. Take 4 hours to recharge the battery to 90% and 5 hours to
100%
ii. Battery time 60 minutes
 Alarm messages
 One console per MCD. Each console is INDEPENDENT of each other.
B. Pump
 Afterload sensitive
 Maximal flow is 10 L/min
 Rotates by magnetic field; no bearings; (does not heat the blood)
 Keep RVAD flows < LVAD flows by 0.5L/min
 31ml priming volume
C. Motor and cable
 Motor:
i. It is to be secured to an IV pole unless transporting the patient.
ii. Do not place warming blankets on this motor.
D. Flow sensor probe: placed on the outflow cannulas to give accurate flow
reading
E. Cannulas
 Suggested cannulation options;
i. RVAD: RA to PA
ii. LVAD: LV to aorta or LA to aorta
 Do not place Bair hugger on cannulas- could cause the blood to
anticoagulate
 Do not cover the cannulas with any coverings
 Should be tunneled
2. Emergency procedures
A. Chest compressions, internal cardiac massage and/ or precordial thump
cannot be administered.
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B. Defibrillation –Defibrillate patient. with no changes to MCD settings.
C. There is no hand pump.
D. For every alarm, check patient first; then, check console to assess what alarm
is on. Check for chatter or a clot in the cannulas and clot within the
pump. Reference card are at bedside to assist in assessing alarm.
E. If MCD is suspected to be off at all, call attending surgeon immediately. May
attempt to switch out motors with Perfusion and/ or MCD coordinator. If MCD
is suspected to be off for > 5 minutes, call attending surgeon immediately for
further guidance prior to attempting to restart pump.
3. Activity
A. Open chest
 Bedrest with head of bed at max of 15 degrees
 Logroll turns only from side to side (with minimum of 3 people - 1
person to watch the device)
 Place pillows in pressure points to decrease risk of pressure ulcer
 After moving patient check catheters for kinking, no change in cannula
position. If any of these occur, notify the cardiac surgery attending
immediately.
B. Closed Chest
 Bedrest only until approved by attending surgeon to allow the patient to
get up to the chair and ambulate.
 Change position every 2 hours if patient tolerates and okayed by
surgeon or place pillows in pressure point areas to decrease the risk of
pressure ulcers.
 After moving patient check catheters for kinking and no change in
cannula position. If any of these occur, notify the cardiac surgery
attending immediately.
4. Monitoring
A. If a pulmonary artery catheter is in place, monitor the CVP, PAP, and PCWP
(LVAD patient only) to maintain adequate fluid volume and for signs of
decreasing fluid status.
B. Arterial waveform will be rounded at the top due to off loading of cardiac
output to device. Use mean arterial pressure as indicator of perfusion.
C. MCD readings and assessments include:
 Flow (L/min) Call cardiac surgery attending for RVAD flows > LVAD
flows
 Speed (rpms)
 Check circuit (both cannulas and ventricle) for ring thrombus in the
MCD ventricle, cannulas and connections.
 Check the circuit for chatter.
i. Circuit Check for Chatter, Clots and for circuit function: :
1. Chatter:
1. Chatter is defined as an irregular filling of the MCD
ventricle due to low preload or speed setting too
high. Chatter is manifested by: changes in MCD
flow readings by 0.4L/min or greater changes. If
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you place your hand on the ventricle, the pump
filling feels irregular and has a “chugging” feeling.
On the inflow cannula, you will feel an irregular
flow of blood through tubing (it may bounce but
needs to meet the other criteria too). Chatter is
NOT found on the outflow cannula side.
2. Touch device and assess for smooth movement of
blood through the device. There should be no
"chattering" on the inflow cannulas. If there is
chatter, notify the attending provider.
3. Decrease in speed should make chatter go away.
Check the circuit again for chatter once change in
speed is made or if fluid is given.
2. Clots: Check cannulas/ connections for signs of clots/
ring thrombus and kinks. If there is a clot: call perfusion
or MCD coordinator and the attending cardiac surgeon
immediately.
3. Check catheters for kinking/obstruction. Notify physician
if kinking is present.
4. Check color of blood in tubing (blue for RVAD and red for
LVAD). If a change in color is noted, notify physician.
5. System Checks every shift:
1. Move flow probe ~1 cm
2. Tubing secured to patient?
3. Tubing bends wide and smooth?
4. On AC power and battery fully charged?
5. Air circulation around motor and console?
6. Two tubing clamps near each blood pump?
7. Backup console ready with battery charged?
8. Low flow alarm set 0.5-1.0 LPM less than target?
9. Review “Emergency Switch to Backup” reference
card
5. Anticoagulation
A. Anti-Xa goal is 0.3-0.7 IU/mL or per provider's orders
B. Systemic heparin should be used to maintain the goal as indicated in #1.
C. Anti-Xa frequency and heparin dosing will be per physician orders.
D. Monitor platelet count per physician orders. Call physician if platelet <
100,000 or per physician orders.
E. Maintain LVAD CentriMag flow > 4.0 LPM or per attending surgeon’s order
F. No anticoagulation for 6-12 hours postoperative unless no CPB or per
attending surgeon’s orders
G. Start heparin infusion when chest drainage < 50 cc/hr for 2-3 hrs
H. Add antiplatelet by the 4th post-op day (for example: 81- 325 mg aspirin per
day)
6. Fluid Status
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A. Monitor patient's volume status- CVP (optimal CVP 10-15 mmHg) per
attending physician or PCWP per heart failure team
7. Skin assessment: close and strict skin assessment to decrease the likelihood of skin
breakdown.
8. Alarms: Troubleshoot according to alarm guide online or on the monitor.
9. Nursing care
A. Document the following per ICU standards (every hour until x 24 hours and
then every 2 hours) per IMC/general care (q 4 hours) or unless specified by
the surgeon’s orders. Document on CentriMag flowsheet
 MCD mode (fixed)
 Pump speed (rpm)
 Any clots present- may consider marking it to monitor for change in
size
 Any chatter
B. Determination of speed: The cardiothoracic surgeon and/or heart failure
attending will determine the appropriate parameters. An order will be written
for parameters. Remember to watch the inlet for chatter.
 Adjust rpm for low flow with line chatter/ shaking or low volume/ low
pressure (CVP)
 Echo assessment for "neutral septum"
 Balance left and right atrial pressures not flows
 For BiMCD, assure LVAD flow > RVAD by 0.5L or more
C. At the bedside:
 2 clamps / pump
 Backup console
i. Console-connected to AC
ii. Console off and battery charged
iii. Motor connected to console
iv. Flow Probe connected to console
v. Pump exchange supplies available
D. Physical Limitations - see section I part 3.
E. Daily Dressing Change - For CentriMag MCD patients, the surgeon will
assess the need of dressing change if the patient's chest is open. If the
patient's chest is closed, nursing staff will do the dressing change per the
MCD driveline dressing change protocol.
10. Transportation
A. Continuously monitor patient's hemodynamics and pump flows
B. Assign one individual to monitor consoles and blood pumps
C. Place blood pump and motor on the bed between the patients legs
D. Insure pumps are visible and tubing positioned to avoid bends
E. Backup console and clamps must always be with the patient
F. Each console has approximately 1 hr of battery power


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11. Supplies for CentriMag Exchange
A. Patient should have current type and screen with blood available
B. ACTs maybe needed (surgeon dependent, drug related [if not on
heparin may not be able to do ACT]
C. Extra CentriMag console, motor and flow probe

Supplies from B45 Supplies from OR/perfusion
 Sterile gowns (Surgeon +
assistant)
 Sterile sheets x 2
 Sterile towels x 2
 Hats
 Masks
 Sterile gloves (1 pr) per surgeon
+ assistant
 Face shields/glasses
 Sterile bowl (1-2)
 One 500ml bottle sterile normal
saline
 2 60 ml leur lock syringes
 2 18G needles (surgeon
dependent)
 Sterile marking pen
 Sterile tape (use foam tape)
 3 boxes of sterile 4x4’s (10
pack)
 Betadine/Betadine spray
 CT bands (4-6) and banding gun
 4 Dura prep
 #10 sterile scalpel x 2
 Heparin bolus (if not allergic)
 Sedation/analgesic
 ? forceps
 Sterile heavy scissors 1-2
 Sterile tubing clamps x 6
 Sterile Aesepto (baster like)
(above 3 items are in B45 sternal
reopen tray if need to use it)
 Sterile CentriMag ventricle
 ½ inch tubing to reinforce
connections out of ventricle
 If heparin allergy: Perfusion to
provide:
 Cellsaver Cardiotomy
 4 lengths of 3/8” sterile tubing
 4 - 3/8” x 3/8” straight
connectors
 ¼ x 3/8 straight connector
 10 Blade – sterile
 Alcohol wipes
 2 Liters Plasmalyte A to prime
CentriMag circuit
12. Weaning: If weaning is ordered by the attending surgeon, the nurse will call the
perfusionist/MCD Coordinator or attending surgeon to adjust settings on MCD
console. Nursing staff will watch for tolerance of the patient with weaning. Any
changes in vital signs, urinary output, physical assessment, and hemodynamics or
MCD alarms will be called to the MCD NP/CNS/ surgeon.
13. Discharge Needs - Does not apply as this is a temporary device.
14. Concerns:
A. Low flow (0.5L-1L)
 Decrease RPM and then diagnose and treat
 Similar response as for other devices
 Possible causes:
i. Interstitial edema
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ii. Cardiac tamponade
iii. Pulmonary vascular resistance
iv. Cannulae selection and position
v. Operating at too high of an RPM
vi. Ventricular function/ dysfunction
vii. Hypovolemia (Bleeding, Fluid Balance)
B. Deposits on connectors
 Size? Shape? Watch. Isolate. Protect.
 If present, change size, shape?
 If loose or obstructing blood flow through the circuit concerning replace
component
C. High RPM (required for normal flow)
 Troubleshoot. Cannula? Position? Suture (too tight)?
D. Hemolysis
 Troubleshoot. Cannula? Position? Suture?
E. Incorrect MCD ventricle mount in motor is incorrectly aligned
 Document. Correct.
F. Thrombus in atria or ventricle
 Same response as for other devices
G. Alarm trouble-shooting: Refer to device manual. Call the MCD coordinator,
attending surgeon or perfusionist on call if needed. Check to make sure the
MCD is running.
 Flow Probe Disconnected
i. Reconnect. Replace if necessary.
 Flow Signal Fail
i. Check probe cover. Reposition. Replace if necessary
 Flow Below Minimum
i. 1 L/min
 Low Battery-15 minutes
 On Battery

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34

HeartMate II LVAD (all UW Health Class I; Level C)

(Thoratec HM II 2005; Feldman et.al, 2013; Slaughter et.al., 2010; Smedira et.al, 2015, van den
Bergh et. al., 2015) http://www.thoratec.com/medical-professionals/resource-library/index.aspx
1. Hospital equipment and stated purpose:
A. Power Module (PM)
 PM must be plugged into an emergency-generator supported outlet at
all times (for inpatient stay).
 PM should be at patient's bedside at all times.
 Patient should go on PM when sleeping or napping.
B. Battery Charger
 Charges 4 batteries at a time
 Leave batteries in the charger. They will not over charge.
C. Batteries
 Two charged batteries - change one battery at a time and assure
power is connected prior to changing to second power source
 Check the batteries prior to transporting patients to tests/leaving room
by pushing alarm reset button on controller to ensure adequate power
in batteries or checking battery charge indicator lights
 Batteries must stay plugged into battery charger.
 Two battery clips will be kept at the bedside.
 One set of batteries should last minimum of 8 hours or change sooner
if indicated by battery gauge light
D. Systems monitor/display monitor
 One of these monitor will be at patient's bedside for an EPC controller
 System monitor may be in room for fresh implants and for those
patients requiring frequency review of their controller history.
E. Controllers PI Readings:
PI Reading Controller Type
2-6 HeartMate 3
3-8 HeartMate II with pocket controller
3-6 HeartMate II with EPC controller
 EPC HM II Controller
i. Program backup controller with the same fixed speed and low
speed limits as primary
ii. Backup controller to be kept at the bedside
iii. System check- hold triangle button down for 5 seconds
iv. No readings are displayed on the controller itself
v. Assure latchguard is secured
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vi. Normal PI 3-6
vii. Defibrillation does not require any changes to controller
viii. Green power symbol button means both controller power leads
have power and without an alarm there is an assumption MCD
is running
 Pocket Controller HM II Controller
i. System check- hold battery button down for 5 seconds. Screen
will go blank for a few seconds then “self test” appears on the
screen.
ii. MCD readings: Push the display button (square) to see each of
the following readings:
1. Speed (rpm)
2. Flow (L/min)
3. Power (w)
4. Normal PI: patient dependent but could range from 3-
8
5. Internal battery charge status
iii. Assure latchguard is secure
iv. Two green arrows at the top if lit signify pump is running
v. Backup controller programming:
1. Installing backup 11v battery
2. Use tools from Thoratec
3. Open outer case and loosen screws.
4. Open inner case and loosen screws to remove cap
5. Connect internal battery to white cable
6. Lay flat inside controller then replace inner case and
tighten screws
7. Replace outer case and tighten screws.
vi. Set date/time on controller
vii. Set fixed and low speed limits
viii. Need to charge backup controller with 2 14 v batteries. Do NOT
connect to system monitor to charge
ix. Patients cannot change internal 11 v battery
F. Backup controller internal charging
 Upon programming a backup controller battery the controller needs to
be charged for 2 hours to charge the internal battery
 Every six months: Recharge internal battery which could take up to 3
hours if patient used it
 Controller battery gauge button does not inform status of internal
battery
2. Anticoagulation
A. Heparin bridging postop is based on time to get INR therapeutic, MCD
readings, past medical history and surgical operation.
B. Goal INR is usually 2-2.5 but maybe changed based on the patient’s past
medical history, MCD readings and surgical operation.
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C. Bivalrudin and argatroban are acceptable alternatives to heparin if required
for patients who are allergic to heparin or have ineffective anticoagulation with
Heparin drip
D. Aspirin 81mg daily should be started on POD 1 if there are no bleeding
complications. This dose maybe adjusted based on surgeon’s discretion.
3. Alarms
A. Silencing: can silence red (2 minutes) and yellow (4 hours)
B. Driveline fault alarm:
 Does not detect shielding problem
 Patient can silence on controller for 4 hours per silence.
 Patient must come to the hospital for evaluation which could take 7
minutes to complete. Thoratec representative will be contacted for
further guidance.
 Hospital personnel after evaluation can clear the alarm if no alarm
reoccurs after clearing the driveline fault alarm then the patient can go
home
 If the alarm reoccurs after 7 minutes then a further evaluation needs to
be done such as x-ray evaluation.
 If you silence alarm- deactivates the alarm forever
C. Alarm review:
 Hold alarm silence display button (square) down simultaneously until
first alarm appears
 First alarm with date/time and alarm duration will appear
 Push display button (square) to scroll through all the alarms
 Only red alarms will be displayed. Yellow alarms such as power cable
disconnect will not appear in the alarm display.
4. Controller exchange requires two people to complete
A. Place into sleep mode after old controller changed out-
 Disconnect both power sources and driveline
 Press and hold battery button for 5 seconds
B. Defibrillation does not require any changes to controller
C. Three options for controller securement (belt attachment, lanyard and
protection bag for backup controller) provided in the controller accessories kit
(from Thoratec)
5. Emergency procedures (see internal VAD webpage)
A. Chest compressions, internal cardiac massage and/ or precordial thump
cannot be administered without approval by attending physician.
B. Defibrillation - do not need to disconnect anything
C. There is no hand pump.
D. For every alarm, check patient first; then, check controller to assess what
alarm is on. Reference card may be in assessing alarm. Call MCD
coordinator for assistance with troubleshooting.
E. For inpatients: If MCD is suspected to be off for > 5 minutes, call attending
surgeon immediately for further guidance prior to restarting the pump.
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F. For outpatients: If it is suspected the MCD is off, call attending surgeon
immediately for guidance whether < 5 minutes or > 5 minutes of stoppage. If
< 5 minutes total stoppage time, attempt to change the system controller.
6. General care of the patient
A. Maintain patient's mean arterial blood pressure 60-80 mmHg or as prescribed
by physician.
7. Nursing care
A. MCD checks must be done while connected to PM for the EPC controller
patients.
B. Document the following on the HeartMate II nursing flowsheet per physician
orders or as needed:
 MCD mode: fixed
 Pump speed (rpms)
 Flow (L/min)
 Pulsatility Index (PI)
 Power (watts)
 Extra system controller @ bedside (same as the patient’s primary
controller)
 Latch guard is intact on the controller/driveline connection.
 System check daily:
C. Determination of speed, flow, and PI: The cardiothoracic surgeon and/or heart
failure attending will determine the appropriate parameters. An order will be
written for parameters. Goal speed should have the aortic valve should be
opening multiple times a minute
D. Latch guard should be on at all times.
E. System check daily
F. Other MCD care processes
 When patient is sleeping, patient must be on PM.
 The following should be at the patient's bedside:
i. Backup controller (preset to patient's settings by
perfusionist, cardiac surgery / MCD CNS, or MCD NP).
G. Activities of Daily Living (ADLs)
 Showers are allowable after patient is educated on proper use of
shower kit by the MCD coordinator and approved by attending
surgeon.
 Physical Limitations - see general care guidelines
H. Daily dressing care per guideline.
8. Discharge needs
A. Learning needs include the following and will be demonstrated by the patient
and family support (See device specific teaching guideline/patient education
record):
 Dressing change: requires multiple demonstrations stating indications
of infection and when to call clinician
 Ability to correctly change batteries and switch from PM/MPU to
battery.
 Ability to perform systems check.
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 Changing controller when indicated
 Understand device alarms and able to troubleshoot alarms.
 Check position of latch guard and assure it is in locked position
 Knowing contact phone numbers and resources
 Emergency care of the device
 Daily care of the device
 Anticoagulation goal
 Activity restrictions
B. Patient will be discharged to home with the following equipment as per
manufacturer's guidelines:
 PM and cable; MPU and cable
 Primary and Backup controller (EPC or pocket controller). The backup
controller must be the same as the patient’s primary controller.
 Backup Controller cell battery
 Battery charger
 # batteries per manufacturer recommendations
 Shower kit
 Battery clips
 Travel bag
 Display Module (for patients with EPC controllers only)
9. Alarm trouble-shooting: Refer to quick reference card (Thoratec HMII Alarm Guide)
located online. Call the MCD coordinator, attending surgeon or perfusionist on call if
needed. Check to make sure the MCD is running.
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39

Heartware HVAD
(Hanke et.al, 2016; Stulak et.al, 2015) http://www.heartware.com/clinicians/resources
1. Hospital equipment and stated purpose:
A. Heartware monitor with AC adapter.
 Set and change controller settings. Only trained personnel can change
the fixed rate setting and mode setting on the Heartware monitor
 Heartware monitor is NOT a power source. One battery needs to
be connected to controller at ALL TIMES.
 Setting speed:
i. Set speed to obtain Pump flow index of 2-2.6L/min/m2
ii. Normal pump operating speed are 2400-3200 rpm with absolute
range of 1800-4000 rpm
iii. Amount of aortic valve opening is still being studied but some
aortic valve opening is recommended.
iv. Setting speed too high can affect smaller vessels and potentially
increase stroke risk
 Setting alarm settings:
i. Set high power alarm 2 watts above average power
ii. Set low flow alarm 2 L/min above average flow but no lower
than 2 L/min
iii. Enable suction alarm once patient is hemodynamically stable
and if attending physician agrees
 Review alarms and download as needed
 Waveforms:
i. Monitor MCD Power and PI waveforms for abnormality
ii. Variations on waveform are indicative of changing clinical
conditions and must be reviewed.
 Monitor has 2 hour battery life. Keep plugged in at all times. Will take
4 hours to recharge and CANNOT change any settings during this
recharge
B. Battery Charger with AC adapter
 Charges 4 batteries at a time
 Leave batteries in the charger. They will not over charge.
 Takes up to 5 hours to charge fully depleted battery
 Battery charge status indicators:
i. Yellow: charging (do not use)
ii. Flashing yellow: battery NOT charging
iii. Red: battery too cold or too hot to charge
iv. Flashing red: defective battery and return to Heartware
C. Batteries
 One battery needs to connected to controller at ALL times.
 Two charged batteries - change one battery at a time and assure
power is connected prior to changing to second power source
 Check the batteries power level on controller prior to transporting
patients to tests/leaving room to ensure adequate power in batteries
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40

 Each battery has their own battery indicator lights
 Controller battery indicators colors:
i. 50-100% power= green
ii. 25-49% power= yellow
iii. ≤ 24%= red
 Batteries must stay plugged into battery charger.
 Batteries should last 4-6 hours EACH
 Batteries drain INDEPENDENTLY of each other
D. Controller
 Four ports on the controller:
i. Blue: monitor cable
ii. Silver port: Driveline connection
iii. Two black ports: power sources (Always one battery +AC
adapter or 2 BATTERIES)
 Controller setup
i. Controller Setup tab: Check date/time is correct
ii. Setup monitor: check date/time is correct
iii. Patient Setup tab:
1. Patient’s Identifier and implant date will be entered
2. Hematocrit
iv. Patient Speed/control tab: Change pump speed and to turn
MCD “ON or OFF”
v. Alarm Settings tab: Patient Alarm settings: set high power and
low flow settings
vi. MCD Setup tab: Enter in Pump HVAD serial number, disable or
enable suction response
vii. Patient set up tab: Download patient log files with at least once
prior to discharge and with every clinic visit.
 Following MCD readings will be displayed on the controller
i. Speed (rpm)
ii. Flow (L/min)
iii. Power (w)
 Power sources:
i. Controller can run on either 1 battery + AC (cord connected to
outlet) or 2 batteries
ii. Controller will display which power sources (battery or AC
outlet) are supplying power on the front of controller display
iii. Make sure you hear a click each time the batteries or AC power
is connected to the controller
iv. Controller preferentially chooses electricity but the electricity will
NOT charge the battery connected to the controller at the same
time
 Two green arrows at the top if lit signify pump is running
E. Alarm review Push scroll button for alarm review
2. Anticoagulation Recommendations
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41

A. All patients will be bridged with an intravenous heparin infusion without bolus
once CT output has decreased. Maximal time patient can be without heparin
is 48 hours.
B. Heparin should be monitored with Anti-Xa to a goal of 0.3-0.7 IU/mL
C. Goal INR is 2-3
D. Bivalrudin and argatroban are acceptable alternatives to heparin if required
for patients who are allergic to heparin
E. Aspirin 325mg daily should be started on POD 1 if there are no bleeding
complications
3. Emergency procedures
A. Chest compressions, internal cardiac massage and/ or precordial thump
cannot be administered.
B. Defibrillation - do not need to disconnect anything
C. In tamponade situations, the flow waveform will be flat along with decreased
MAP, increased CVP, decreased MCD flow and decreased pump pulsatility
D. There is no hand pump.
E. For every alarm, check patient first; then, check controller to assess what
alarm is on. Reference card at bedside to assist in assessing alarm. Call
MCD coordinator for assistance with troubleshooting.
4. General care of the patient
A. Maintain patient's mean arterial blood pressure 60-80 less than 90 mmHg or
as prescribed by physician.
5. Nursing care
A. MCD checks can be done using monitor for all readings (including alarm
settings) and MCD readings only on controller
B. Document the following on the Heartware nursing flowsheet per physician
orders (ICU: q 1 hr until stable then q 2hrs) (IMC/general care: q 4hrs) or as
needed:
 MCD mode: fixed
 Pump speed (rpms)
 Flow (L/min)
 Power (watts)
 Suction detection (on or off)
 Low flow alarm setting
 High power alarm setting
 Extra system controller @ bedside
 Check connections are tight
 Hematocrit used for MCD readings
C. Hematocrit value will be changed with every new hematocrit result.
D. Waveforms for Power and Flow
 Inpatients: These waveforms will be reviewed frequently while in ICU
and also during the duration of their hospitalization. Attending
provider, MCD coordinator or MCD NP will be notified of any changes
to these waveforms.
 Outpatients: Waveforms and trends will be reviewed with every clinic
visit.
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42

E. Other MCD care processes
 When patient is sleeping, patient must be on AC outlet.
 The following should be at the patient's bedside:
i. Backup controller (preset to patient's settings)
F. Activities of Daily Living (ADLs)
 Showers are allowable after patient is educated on proper use of
shower kit by the VAD coordinator and approved by attending surgeon.
 Physical Limitations - see general care guidelines
G. Daily dressing care per guideline.
6. Discharge needs
A. Learning needs include the following and will be demonstrated by the patient
and family support (See device specific teaching guideline):
 Dressing change: requires multiple demonstrations stating indications
of infection and when to call clinician
 Ability to correctly change batteries and switch from AC power to
battery. Ability to know what power sources the controller is pulling
from and when to change batteries.
 Understand device alarms and able to troubleshoot alarms.
 Changing controller when indicated
 Knowing contact phone numbers and resources
 Emergency care of the device
 Daily care of the device
 Anticoagulation goal
 Activity restrictions
B. Patient will be discharged to home with the following equipment as per
manufacturer's guidelines:
 Primary and Backup controller with AC adapter and alarm adapter
 # batteries per manufacturer recommendations
 Shower bag
 Travel bag
 DC controller adapter
 Battery charger
 Patient pack
7. Alarm troubleshooting: Refer to quick reference card (Heartware Alarm Guide)
located at the bedside and device manual. Call the MCD coordinator, attending
surgeon or perfusionist on call if needed. Check to make sure the MCD is running
(see internal VAD webpage for additional references).
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43

Thoratec TLC ii 2001, IVAD 2004, Dual Drive Console (UW Health Class I; Level C)
http://www.thoratec.com/medical-professionals/vad-product-information/index.aspx
1. Equipment
A. Dual Driver console (DDC) or TLC-II console
2. Special equipment instructions
A. Dual Drive Console
 Max flow is 7 Liters and Stroke Volume (SV) is 65 ml
 Volume mode preferred.
 Connection boxes for reinforcing the 7 foot and 5 foot cables will be
used.
B. TLC-II
 Backup cables will be available both 7 foot and 5 foot connections to
transfer patients to and from the DDC to the TLC-II driver per provider
orders.
 Connection to TLC-II are 5 foot connections
 Docking station is used to program TLC-II driver and is the only place
to make changes. It will be kept available on the unit.
 TLC-II driver is exchanged per manufacturer's guidelines for required
maintenance.
 TLC-II batteries can last up to 80 minutes on a single MCD, and 55
minutes on a BiVAD.
 Do not keep batteries inside the charger once the green light appears
to prevent development of memory.
3. Anticoagulation
A. All patients will be bridged with an intravenous heparin infusion without bolus
once CT output has decreased. Maximal time patient can be without heparin
is 48 hours or per surgeon discretion.
B. Initial anti-Xa goal is 0.3-0.7 IU/mL
C. On post op day 2 or 3 and until INR is therapeutic the anti-Xa goal is 0.7-1.0
IU/mL
D. Goal INR is 2.5-3.5
E. Bivalrudin and argatroban are acceptable alternatives to heparin if required
for patients who are allergic to heparin
F. Aspirin 325mg daily should be started on POD 1 if there are no bleeding
complications
4. Emergency procedures
A. Thoratec is electrically isolated so there is no need to disconnect prior to
defibrillation.
B. For device failure, follow emergency procedures as outlined in Thoratec
operating manual for hand pumping.
C. Chest compressions, internal cardiac massage and/or precordial thump
cannot be administered.
D. For MCD stoppage:
5. Nursing care for Dual Drive console
A. CTICU monitoring includes MCD checks every hour and as needed for 24
hours, then every 2 hours and as needed or per physician orders; CT
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44

tele/IMC monitoring includes MCD checks every 4 hours and as needed or
per physician orders.
B. The following needs to be recorded on the Thoratec flowsheet: The following
should be on a Dual Drive Console flowsheet:
 Flow (L/ min)
 Mode (async or volume)
 Rate (beats/minute or bpm)
 Observe complete pump filling by green fill light
 Observe complete pump emptying through flash test (paracorporeal) or
empty signal on signal processor (implantable version)
 Listen for audible MCD clicking
 Check for cannula kinking at exit site
 Document hand bulbs at bedside (1 for LVAD/RVAD, 2 for BiVAD)
 Check AC power is on and plugged into emergency-generator
supported outlet.
 Vacuum or fill pressure via display screen (-25 to 40 mmHg); if chest is
open, no more than -25 mmHg
 Stroke Volume (SV) (mL)
 Percent systole (close to 30% unless ordered by attending physician)
 Eject time (close to 300 msec unless ordered by attending physician)
 MCD drive pressures
i. LVAD 200 - 245 mmHg
ii. RVAD 140-160 mmHg
 RVAD flow should always be less than LVAD by 0.5 L/min
C. DDC battery lasts 30 minutes and takes 12 hours to charge.
6. Nursing care for TLC-II console
A. Document the following on the Thoratec TLC-II nursing flowsheet:
 Mode (fixed or auto)
 Rate (bpm): (beat and low)
 Flow (L/min)
 Fill light
 Flash test or empty signal on signal processor
 Listen for audible MCD clicking
 Check if there is cannula kinking at exit site
 Document hand bulbs @ bedside (1 for LVAD/RVAD, 2 for BiVAD)
 Check if AC power is on and plugged into red outlet
B. Docking Station:
 When the patient is transferred from DDC to the TLC-II console- the
settings are determined in conjunction with a review of previous MCD
readings on the DDC, patient's hemodynamics, and in discussion with
the Thoratec representative (if needed), physician and MCD
coordinator. Once the final settings are determined by the physician,
the TLC-II is programmed and the patient is transferred to this console.
After transfer from one console to the other, assess proper MCD
function (especially appropriate filling and emptying of the device(s)).
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45

 When plugged into the Docking Station, the following will be
documented in the patient's chart by the MCD coordinator (for
inpatient/outpatients):
i. Accumulator pressure (mmHg)
ii. Fill light presence
iii. Vacuum (mmHg)
iv. Beat Rate (bpm)
v. Low Rate (bpm)
vi. Eject time (msec)
vii. Mode: Front panel disabled in auto or fixed mode
viii. Alarms
ix. For implantable version: flags on the plot screen and if there is
the consistent flashing light on the empty signal processor. (If
one is not seen, the MCD coordinator or physician will
troubleshoot according to Thoratec Recommendations). This
allows assessment of the appropriate setting of eject/
accumulator pressure.
C. If there is no fill light; the nurse should notify the physician, perfusionist or
MCD Coordinator.
D. Empty signal assessed every 2-4 hours as outlined in this guideline or per
physician order. If abnormal, nurse will notify physician/surgeon, perfusionist,
or MCD Coordinator. (They will troubleshoot using the Thoratec
recommendations).
E. Thoratec driveline will be immobilized at all times using the specified
abdominal binder or driveline holder per attending surgeon's orders.
F. Extra fill or signal processor cable will be at bedside.
G. Activity Limitations: see general care guidelines
H. Batteries: Two batteries are required to run this console. Do not disconnect
both batteries at the same time because the pump will stop.
I. If patient goes off the unit, check battery time prior to leaving unit. Take extra
battery(s) if needed, power cord for TLC-II console and hand pump(s).
7. Switching to TLC-II Driver to TLC-II driver if the original has failed, there is a concern
or required for maintenance per manufacturer's recommendations. MCD coordinator,
physician/surgeon or perfusionist will supervise any changeover to a second
console.
A. Insert a fully charged battery into each battery slot of backup driver.
B. Turn key switch to "On" position.
C. Remove occluder from appropriate pneumatic port. For BiMCD, switch LVAD
first.
D. Disconnect pneumatic lead from primary driver to back up console. If unable
to connect then initiate hand pumping and call attending surgeon.
E. Hand Pumping:
 If hand pumping required at any time, notify attending surgeon and/or
perfusion or VAD Coordinator.
 Follow the steps below to hand pump: Rate 60-80 bpm
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46

i. Disconnect pneumatic lead(s) from the Dual Driver or TLC-II
driver and connect to hand pump(s).
ii. Squeeze hand pump(s) once per second. Using a foot is
acceptable if fatigue occurs to maintain pumping.
iii. For BiMCD , never hand pump the RVAD faster than the LVAD
as this may cause pulmonary edema.
iv. Connect to the back up driver as soon as possible.
F. Disconnect electric lead(s) from primary driver and connect to back up driver.
G. Verify full signal(s) are being received from MCD(s) & MCD(s) are ejecting
completely
H. Connect to docking station to verify the settings (MCD coordinator/
perfusionist or physician/surgeon).
I. Connect to external power source.
J. Turn off original console and remove from service until serviced by Thoratec.
8. Discharge
A. Learning needs include the following and will be demonstrated by the patient
and family support (See device specific teaching guideline):
 Dressing change: requires multiple demonstrations, stating indications
of infection and when to call clinician
 Ability to correctly change batteries on TLC-II driver.
 How to change from one driver to another
 Understands device alarms and able to troubleshoot alarms.
 Knowing contact phone numbers and resources
 Daily care of the device
 Emergency care of the device including how to change to new console
 Anticoagulation goal: INR 2.5-3.5
 Activity restrictions
 Changing TLC-II console to TLC-II console (how to, when indicated)
 Hand pumping
 Discharge equipment:
i. Battery charger
ii. Batteries (number per manufacturer recommendations)
iii. Car adapter
iv. AC power cord x 2
v. Backup TLC-II with same programmable settings as primary
console
vi. Backup electrical cables based on IVAD vs. PVAD
vii. Hand pumps x 2 per console
viii. Mobility cart x 2 (one per console)
9. Alarm trouble-shooting for TLC-II per Thoratec TLC-II alarm guide located at the
bedside or device manual.
10. Complete filling indicated by green fill light on TLC-II driver control panel or DDC if
light is absent:
A. Dependent on adequate preload.
B. Reasons include the following:
 Hypovolemia
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47

 Bleeding
 Tamponade
 Vasodilatation
 Inadequate pharmacologic support
 Right ventricular failure
 Arrhythmias with isolated LVAD
 MCD inflow cannula position
 Vacuum too low
 Beat rate too high
 Eject time too long.
C. Troubleshooting includes the following as ordered by providers:
 Treat the cause
 Decrease the beat rate
 Increase the vacuum
 Decrease the eject time without compromising complete ejection
11. Inadequate MCD emptying
A. With implantable MCD, assess by presence of green empty light on signal
processor. If absent, check for empty flag on pressure tracing on plot screen.
B. Reasons for inadequate emptying:
 Systolic pulmonary artery or arterial blood pressure too high.
 Outflow cannula kinked.
 Accumulator pressure too low.
 Eject time too short.
C. Troubleshooting as ordered by providers:
 Assess paracorporeal outflow canola for kinks.
 For IVAD check signal processor lead connections and percutaneous
line for kink.
 Increase accumulator pressure (affects LVAD only).
 Increase ejects time.
 Lower patient's systolic pressure.
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48

Total Artificial Heart (Syncardia)
http://www.syncardia.com/medical-professionals/tah-for-medical-professionals/itemid-1530.html

1. Hospital equipment and stated purpose:
A. Heart
 70ml heart with 4 flexible polyurethane diaphragms
 Blood flow is similar to native heart
 No surgical pocket required
 All of the native heart muscle and 4 native valves are removed except
back part of atrias.
 Inflow cuffs attach to atria
 Outflow is Dacron and sprayed with CoSeal to prevent leaks
 TAH valves: mechanical
 Normal output is 6-9L/min
 Goal Cardiac Index is 2.5L/min
B. Acceptable vasoactive drips: vasopressors and vasodilators



C. Cannulas/driveline
 Driveline is 7 feet to companion driver
 Do NOT step on/move equipment over driveline
 Do NOT kink external drivelines
D. Companion Driver
 Each external console contains primary and backup controller. Need
another external console.
E. Freedom Driver
 AC power does NOT charge batteries
F. Batteries
 Companion Driver
i. Two external batteries
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49

ii. Charges when driver is connected to AC power using hospital
cart/caddy
iii. Each battery charges and discharges simultaneously
 Freedom Driver
i. Weighs 13 pounds
ii. 1 hour charge per battery
iii. takes 1 hour to charge battery
iv. discharged with 6 batteries
v. No memory, no interrogation
G. Dummy battery
 Placed in backup and once it is removed and another battery is placed-
driver will start
H. Battery Charger
2. TAH Physiology
A. FILL: Goal-SV 50-60ml
 Keep TAH partially filled so that when patient is up/active can have
reserve to compensate for increased venous return to augment CO
 If you have a FULL fill state- increase beat rate to increase off loading
 < 50ml may indicate failure of one of the diaphragms in artificial
ventricle
 Maintain flow to wash the ventricles
B. EJECT: Goal-complete ejection to prevent thrombus
C. If too much sodium present, it leads to fluid overload demonstrated by
(increase weight, full fill partial eject causing pulmonary edema)





Full fill: cannot complete the ejection, t full fill will drop to baseline on
waveform but number on the fill s may look normal

Partial eject: need to manage medically
• Partial Fill
50-60ml
• When patient up active- reserve in heart to
accommodate increase venous return
• No alarm for low fill unless < 3.5L

• Full Eject: possible low risk of thrombus

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50

3. Waveforms
A. All Waveforms (MEASURES AIR NOT BLOOD)
1= pressure (systole: eject phase, inflow valve closed)
2= eject (inflow valve opens)
3= fully ejected more air to push diaphragm to complete eject (max/min
pressure) Should see a full eject flag
4= decompression spike (release pressure)
5= fill on blood side (inflow valve open)
6=end diastolic filling
7= drop to zero for full filling (do NOT want this)





B. Pressure waveform:
 Fully eject flag on Pressure waveform helps determine PA pressure
(no full eject flag=equilibrated PAs)
C. Flow
4. TAH Preferred Settings:
A. Cardiac Index 2.5L/min
B. % systole= 50±5
C. Drive Pressure:
 Left systolic drive pressure 50-60 mmHg > SBP (180-210 mmHg)
 Right systolic drive pressure 30-40 mmHg > PASP (60-100 mmHg)
D. Beat Rate 125 ± 15 bpm
E. Fill volume: 50-60ml
F. Vacuum
 Right: 0 to -10 mmHg
 Left 0 to -13 mmHg
5. Nursing Awareness
A. Initial postop: CVP mid teen’s ok. Then, keep CVP 8-10 mmHg (keep
fluid status on the dry side)
B. Increased venous return=increase TAH stroke volume
Eject Phase  Time  Fill Phase
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51

C. Blood Product Administration:
 Thrombocytopenia is expected. Transfuse only if bleeding
 Patient’s usually are anemic at Hct low 20’s- no need to transfuse
unless for other reason than low H&H. Transfuse only if bleeding
 Hemolysis is not unexpected
 Blood bank blood: best if blood is < 10 days old to decrease
amount of hemolysis
 Non emergent blood transfusions must be approved by cardiac
surgeon
D. IV Access:
 Acceptable IV access: midlines, introducers
 No PICCS, No triple lumen catheters, No, pulmonary artery catheter
E. Medications:
 No Amicar, FEIBA
 Acceptable vasoactive drips: vasopressors and vasodilators
 Following vasoactive drips are NOT recommended:
i. Nitroglycerine (not effective)
ii. inotropes (not needed)
iii. No Nesiritide (become addicted to it and cannot wean off)
F. No warming blanket or heating pad to driveline or cannula
G. No EKG, No MRI
6. Respiratory care:
A. No chest physiotherapy unless approved by cardiac surgeon
B. No differences in ventilator settings unless patient autocycling then
avoid pressure control
C. Avoid high PEEP levels which can affect preload to the heart
7. Patient management: Providers will utilize the Total Artificial Heart Order set to
manage these patients postoperatively.
8. Anticoagulation:
A. Providers will utilize the TAH Supplemental Heparin Anticoagulation Order
set.
B. Medications:
 Aspirin will be started once CT drainage < 30ml for 4 hours and
platelets 50,000. Platelet factor assay will assist in increasing aspirin
dose to a maximum of 325mg daily.
 Dipyridamole will be started once platelets are about 50,000 and will
be increased to maximal dose of 400mg daily based on platelet count.
 Pentoxifylline will be started at 400mg q 8 hours.
 Coumadin will be managed using INR.
 Heparin drip will be managed using PTT.
C. Thromboelastogram (TEG) will be utilized as indicated by the provider.




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52

Anticoagulant
Agent Initiate Dose Target Adjustment Monitoring Comments
Heparin When chest tube
drainage <30
mL/hr over 4 hrs
No bolus
5
units/kg/hr
TEG
(with & w/o
heparinase)
R: 5-11 mins
K: 1-4 mins
CI: -3 to 3
R time
< 5 mins: ↑ rate by 2 units/kg/hr
> 11 mins: ↓ rate by 2 units/kg/hr
Twice daily TEG
(AM & PM Lab)
Usual infusion rate
10-15 units/kg/hr to
maintain
normocoaguability
Warfarin When hepatic
function
normalizes and
stable diet
Approx day 7
2.5
mg/day
INR 2.5-3.5 Use conservative dose
adjustments
Daily INR
(AM Lab)

Antiplatelet
Agent Initiate Dose Target Adjustment Monitoring Comments
Aspirin When chest tube
drainage <30
mL/hr over 4 hrs
AND platelets >
50,000
81 mg/day

Max: 325
mg/day
PFA-100 >
210
AA: >80%

PFA-100
< 210: ↑ by 81 mg/day

AA
< 80%: ↑ by 81 mg/day
Daily
PFA-100 or AA
(AM Lab)
PFA-100 preferred
method
If platelet count <
100 k/uL and HCT
<25% then use AA
test

Dipyridamole
When platelets >
50,000
100 mg
every 8
hrs

Max: 400
mg every
8 hours
Platelet count:
75 – 100 k/uL

Increase by 100 mg/day if
platelet count > 100 k/uL
Daily Platelets
(AM Lab)

Viscosity Reducer
Agent Initiate Dose Target Adjustment Monitoring Comments
Pentoxifylline Upon arrival to
ICU
400 mg
every 8
hrs
NA Decrease to 200 mg every 8 hrs
or 400 mg every 12 hrs for
nausea/vomiting

TEG – thromboelastography; R – clot time; K – clot strength; CI - coagulation index; PFA-100 – platelet function assay; AA – platelet mapping with arachidonic acid
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53

9. Nursing Procedures
A. Upon arrival check zip ties on each driveline/cannulae connection are secure
B. Document the following on TAH flowsheet (q 15 minutes x 4, q 30minutes x 4,
then every hour until TAH cardiac outputs are stable x 4 hours then q 2 hours
 Measured Cardiac Output (left, right) (L/min)
 Average Cardiac Output (left, right) (L/min)
 Fill (left, right) (ml)
 Vacuum (left, right) (mmHg)
 Rate (bpm)
 Pressure (left, right) (mmHg)
 % systole
 Fill waveform assessment
 Flow waveform assessment
C. Use red outlets for continuous power supply
D. Prior to walking patient: Check both batteries’ power before walking
E. Safety Check:
 Check external drivelines for kinking. Prevent external driveline from
kinking which will decrease/prevent blood flow in and out of heart
 Check backup driver once a shift if any changes were made to primary
driver
F. Ensure Key is in the back drawer
10. Modes:
A. Use OR mode in OR
 Password require to enter OR mode (3228)
 Full menu access including system check
 Muted alarms
B. Use ICU mode in ICU
 Password 9722 required to enter ICU mode from ambulatory mode
 Double confirmation required for parameter changes
C. Ambulatory mode:
 No parameter changes allowed
 Ability to minimize graph and settings data
11. Driveline dressing:
A. Only water-soluble antiseptic cleaners around exit site.
B. No ointments, acetone, sticky tape/adhesives.
C. Cover clips on cannulas to driveline with 4x4 to prevent skin breakdown
D. Keep driveline stabilized at ALL times. Use abdominal binder.
E. Follow the standardized process for all MCDs.
12. Alarms
A. Any Low Cardiac Output alarms: inspect external driveline for kinking
13. Emergency Procedures
A. Tamponade: decrease cardiac output, increase CVP (likely blood clot
pressing on IVC); no specific time frame
 Sudden decrease in TAH-t flow due to kink in pneumatic drivelines or
some inflow obstruction to TAH-t= tamponade

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B. Hand pump: use only when backup driver is NOT available
 Pump at 110bpm per minutes to maintain adequate cardiac output
C. Switching to backup Companion Driver
 Turn on backup driver
 Driver will begin operating in previous settings
 Move driveline connector from primary to backup (depress tab on side
of connector to disconnect)
 Verify adequate battery charge and/or AC power supply
 Notify Syncardia
D. Switching Freedom Driver
 Prepare
 Turn on primary Freedom Driver
 Cut wire tires
 Simultaneously disconnect red and blue cannula from companion
drivelines and connect to red and blue Freedom drivelines
 Secure connector release buttons with wire ties
 Notify Syncardia
14. Maintenance of equipment:
A. Change filter to companion driver when console notifies you about every 30
days (obtained from Syncardia)
 Two filters on each side of driver
 Can replace/clean as needed. Filters can be rinsed, air dried and
reused.
 Reset alarm on setup menu
B. Every 90 days: exchange new companion driver for service check and return
to Syncardia for maintenance
15. Transition to Freedom Driver
A. No waveforms on Freedom Driver
B. Readings: beat rate, cardiac output, fill volume
C. Only setting is beat rate

Decrease in cardiac
output
Decrease in
fill volume
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D. Cannot manipulate vacuum or pressure
16. Post Discharge
A. Monitor BP twice a daily
B. Weight daily
Guideline for Inpatient Rehab
1. Device specific information will be provided to the inpatient rehab staff at the time of
admission to the unit by the MCD coordinator.
2. Anticoagulation management will be determined by the heart failure, cardiac
surgeon and rehab physician.
3. Inpatient rehab nurses should follow the general care section and device specific
section of the guideline.
4. Activity
A. No lifting greater than 10 pound or per the orders of the attending surgeon
B. Sternal precautions should be followed unless changed by attending surgeon
 No pulling with arms to position patient
 No arms above their shoulders
 No pushing off with their arms
C. Sleeping/napping: patient must be plugged into constant electrical source
(device appropriate console)
D. No pulling with arms to position patient.
E. Gait belt maybe used but care needs to be demonstrated to prevent kinking of
the driveline.
5. Bathing
A. Showers are allowable after patient is educated on proper use of shower kit
by the MCD coordinator and approved by attending surgeon. Shower kit must
be used as per device specific.
6. Eating
A. Pump is near stomach so patient may not be able to eat 3 full meals per day;
6 small meals daily is better tolerated by some patients
B. Protein intake is the most important food intake to promote wound healing.
7. General information
A. MCD driveline dressing will be changed daily (fresh implants or showering
patients) or twice a week (as determined by the MCD team) by inpatient
rehab nurses.
B. Patient level of independence with the device will be assessed by the MCD
coordinator prior to arrival to inpatient rehab. Instructions about their
independence in MCD care will be written by the cardiothoracic surgery team.
C. Battery duration and alarms are based on each individual device. See device
specific sections.
D. Hand pump must be with patient at all times (Thoratec and Total Artificial
Heart)
E. System check or speaker test will be done by daily (HeartMate II and
HeartMate 3 only )
8. Emergencies
A. No chest compressions
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B. No external defibrillation without cardiothoracic nurse, MCD coordinator or
physician. Patient may have an active implantable cardio-defibrillator.
C. If there is a MCD alarm, check that pump is running (listen to the patient’s
chest) and notify cardiothoracic surgical unit immediately. Pump needs to be
restarted in less than 5 minutes to prevent stagnant blood. Call heart failure
attending immediately.
Maintenance of Mechanical Circulatory Device Equipment
1. MCD equipment is housed in both the OR’s pump room and cardiothoracic surgery
unit equipment room.
2. This hospital will have equipment for each device that allows us to monitor the
patient’s VAD readings, download information to send to the device company and
change readings if necessary.
3. OR equipment:
A. The OR’s equipment is managed by the perfusion staff. Annual maintenance
for this equipment is arranged by the perfusion staff.
4. Cardiothoracic Surgery Unit:
A. When a patient is implanted with a MCD, their discharge equipment is
ordered by the MCD coordinator. MCD coordinator will log in and set up the
equipment prior to the patient’s discharge. The discharge equipment is
charged to the patient’s inpatient stay by the MCD coordinator unless the
patient is utilizing Continuum DME.
B. For all Thoratec Dual drive console, Total Artificial Heart consoles and
Freedom Driver and, annual maintenance is done by device company’s
contracted personnel.
C. Thoratec power module internal batteries can be installed by the MCD
coordinator after training from Thoratec (for patient and hospital equipment).
Mobile power unit batteries will installed by the MCD coordinator after training
by Thoratec.
D. Annual maintenance on patient’s owned equipment is arranged by the MCD
coordinator with when the patient returns to clinic for those patients who own
their equipment. For patients being followed by Continuum, their annual
maintenance will be arranged by Continuum.
E. If a patient is readmitted to the unit and needs a new piece of equipment, it
will be arranged by the MCD coordinator and charged during the inpatient
stay. For example, if the patient comes in with a controller issue and it is
changed out, the new controller is charged to that inpatient stay.
F. When the MCD is explanted at transplant, after death or at myocardial
recovery, the patient or family member can donate the equipment back to
UWHC. When they do this, they sign the voluntary donation of ventricular
assist device form indicating the equipment is donated. Donated equipment
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57

is cleaned and inspected when received. Defective equipment is discarded.
Single use items are discarded.
5. Cardiology Clinic:
A. If a patient is an outpatient and they need new equipment, this equipment will
be given in clinic or shipped to the patient. The charge will be done through
the cardiology clinic. Equipment are replaced based on manufacturer’s
recommendations. Charges will be filed as appropriate based on company
warranty or expired company warranty.

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58

UW Health Implementation
Potential Benefits: MCD therapy is very complex for practitioners to manage. These
guidelines provide the consensus statements based on national and device company
recommendations.

Potential Harms: If device specific VAD or MCSD care is not followed, it could compromise the
device’s performance and may affect the patient. The major subgroup(s) of patients with the
target population most likely to suffer harm/adverse consequences associated with the guideline
recommendations will also be described.

Pertinent UW Health Policies & Procedures
1. A heart failure physician, cardiac surgeon, and MCD (VAD) coordinator are available 24/7.
2. UWHC Policy 1.40- Ventricular Assist Device (VAD): Inpatient and Outpatient
3. UWHC Policy 8.39AP- Repair or Replacement of Essential Equipment in Case of Breakdown
4. UWHC policy 14.21- Patient and Family Education

Patient Resources:
1. MyLVAD.com
2. Thoratec Patient Portal (www.thoratec.com)
3. Health Facts For You #3095- Going Home with a Ventricular Assist Device (Binder)
4. Health Facts For You #6681- Ventricular Assist Device Overview
5. Health Facts For You #7541- Going Home with a Heartware HVAD
6. Health Facts For You #6440- Going Home with HeartMate II LVAD
7. Health Facts For You #6674- Going Home with Thoratec TLC-II
8. Health Facts For You #1173- Teaching Guideline for Discharge with a TLC-II VAD
9. Health Facts For You #1174- Teaching Guideline for Discharge with a HeartMate II VAD
10. Health Facts For You# 6163- Exercise for People with a Ventricular Assist Device (VAD)
11. Health Facts for You #6900 – Warfarin (Coumadin, Jantoven)

Implementation Plan/Clinical Tools
1. Guideline will be housed on uConnect in a dedicated space for Clinical Practice Guidelines.
2. References will be added to appropriate policies such as UWHC Policy 1.40.
3. Links to the guideline will be created on the MCD/VAD Resources Webpage and within
appropriate Health Link or equivalent tools.
4. Release of the guideline will be advertised in the Physician/APP Briefing newsletter.
5. The following order sets will be updated as needed to reflect these recommendations:
ξ IP-Destination Therapy Mechanical Circulatory Device Evaluation- Adult-Supplemental (5447)
ξ IP- Pre-Ventricular Assist Device-Adult- Admission (5851)
ξ IP – Ventricular Assist Device – Adult – Preoperative [2708]
ξ IP – Ventricular Assist Device – Adult – Postoperative [3194]
ξ IP – Ventricular Assist Device – Adult – Discharge [3218]
ξ IP – Ventricular Assist Device – Adult – Readmission [2578]
ξ IP – Total Artificial Heart – Anticoagulation – Supplemental [5559]
ξ IP – Total Artificial Heart – Adult – Postoperative [4871]

Disclaimer
Clinical Practice Guidelines are described to assist clinicians by providing a framework for the evaluation
and treatment of patients. This Clinical Practice Guideline outlines the preferred approach for most
patients. It is not intended to replace a clinician’s judgment or to establish a protocol for all patients. It is
understood that some patients will not fit the clinical condition contemplated by a guideline and that a
guideline will rarely establish the only appropriate approach to a problem.
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Appendix A. INTERMACS Profiles of Advanced Heart Failure

Source: http://www.uab.edu/medicine/intermacs/appendices-4-0/appendix-o-4-0. Accessed on 01/06/2016

INTERMACS® Patient Profile at time of implant: Select one. These profiles will provide a
general clinical description of the patients receiving primary LVAD or TAH implants. If there is
significant clinical change between the initial decision to implant and the actual implant
procedure, then the profile closest to the time of implant should be recorded. Patients admitted
electively for implant should be described by the profile just prior to admission.

INTERMACS® 1: Critical cardiogenic shock describes a patient who is “crashing and
burning”, in which a patient has life-threatening hypotension and rapidly escalating
inotropic pressor support, with critical organ hypoperfusion often confirmed by worsening
acidosis and lactate levels. This patient can have modifier A or TCS (see ‘Modifiers’
below)

INTERMACS® 2: Progressive decline describes a patient who has been demonstrated
“dependent” on inotropic support but nonetheless shows signs of continuing
deterioration in nutrition, renal function, fluid retention, or other major status indicator.
Patient profile 2 can also describe a patient with refractory volume overload, perhaps
with evidence of impaired perfusion, in whom inotropic infusions cannot be maintained
due to tachyarrhythmias, clinical ischemia, or other intolerance. This patient can have
modifiers A or TCS.

INTERMACS® 3: Stable but inotrope dependent describes a patient who is clinically
stable on mild-moderate doses of intravenous inotropes (or has a temporary circulatory
support device) after repeated documentation of failure to wean without symptomatic
hypotension, worsening symptoms, or progressive organ dysfunction (usually renal). It is
critical to monitor nutrition, renal function, fluid balance, and overall status carefully in
order to distinguish between a patient who is truly stable at Patient Profile 3 and a
patient who has unappreciated decline rendering them Patient Profile 2. This patient
may be either at home or in the hospital. Patient Profile 3 can have modifier A, and if in
the hospital with circulatory support can have modifier TCS. If patient is at home most of
the time on outpatient inotropic infusion, this patient can have a modifier FF if he or she
frequently returns to the hospital.

INTERMACS® 4: Resting symptoms describes a patient who is at home on oral therapy
but frequently has symptoms of congestion at rest or with activities of daily living (ADL).
He or she may have orthopnea, shortness of breath during ADL such as dressing or
bathing, gastrointestinal symptoms (abdominal discomfort, nausea, poor appetite),
disabling ascites or severe lower extremity edema. This patient should be carefully
considered for more intensive management and surveillance programs, which may in
some cases, reveal poor compliance that would compromise outcomes with any therapy.
This patient can have modifiers A and/or FF.

INTERMACS® 5: Exertion Intolerant describes a patient who is comfortable at rest but
unable to engage in any activity, living predominantly within the house or housebound.
This patient has no congestive symptoms, but may have chronically elevated volume
status, frequently with renal dysfunction, and may be characterized as exercise
intolerant. This patient can have modifiers A and/or FF.
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60

INTERMACS® 6: Exertion Limited also describes a patient who is comfortable at rest
without evidence of fluid overload, but who is able to do some mild activity. Activities of
daily living are comfortable and minor activities outside the home such as visiting friends
or going to a restaurant can be performed, but fatigue results within a few minutes of any
meaningful physical exertion. This patient has occasional episodes of worsening
symptoms and is likely to have had a hospitalization for heart failure within the past year.
This patient can have modifiers A and/or FF.

INTERMACS® 7: Advanced NYHA Class 3 describes a patient who is clinically stable
with a reasonable level of comfortable activity, despite history of previous
decompensation that is not recent. This patient is usually able to walk more than a block.
Any decompensation requiring intravenous diuretics or hospitalization within the
previous month should make this person a Patient Profile 6 or lower. This patient may
have a modifier A only.

MODIFIERS of the INTERMACS® Patient Profiles:

A - Arrhythmia. This modifier can modify any profile. Recurrent ventricular tachyarrhythmias
that have recently contributed substantially to the overall clinical course. This includes frequent
shocks from ICD or requirement for external defibrillator, usually more than twice weekly.

TCS –Temporary Circulatory Support. This modifier can modify only patients who are
confined to the hospital, Patient Profiles 1, 2, and 3 (a patient who is listed as Patient Profile 3
stable on inotropes who has been at home until elective admission for implantable VAD cannot
have a TCS modifier); support includes, but is not limited to, IABP, ECMO, TandemHeart,
Levitronix, BVS 5000 or AB5000, Impella.

FF – Frequent Flyer. This modifier is designed for Patient Profiles 4, 5, and 6. This
modifier can modify Patient Profile 3 if usually at home (frequent admission would
require escalation from Patient Profile 7 to Patient Profile 6 or worse). Frequent Flyer is
designated for a patient requiring frequent emergency visits or hospitalizations for
intravenous diuretics, ultrafiltration, or brief inotropic therapy. Frequent would generally
be at least two emergency visits/admissions in the past 3 months or 3 times in the past
6 months. Note: if admissions are triggered by tachyarrhythmias or ICD shocks then the
modifier to be applied to would be A, not FF.


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Appendix B. Summary of Interim Revisions
Date Summary of Interim Revision(s) Section (Page #)
06/2016
Removal of recommendations for heparin monitoring
and dose titrations using PTT
Recommendations
(13,30,41,43)
03/2017
Revision of recommendations describing evidence
supporting administration of plasma prior to non-
cardiac OR procedures for warfarin reversal
Recommendations
(20)



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62

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