Download Mechanical Circulatory Support Device Database of the

REGISTRY REPORT
Mechanical Circulatory Support Device Database of the
International Society for Heart and Lung Transplantation:
Second Annual Report—2004
Mario C. Deng, MD, Leah B. Edwards, PhD, Marshall I. Hertz, MD, Amanda W. Rowe, BA,
Berkeley M. Keck, MPH, Robert Kormos, MD, David C. Naftel, PhD, and James K. Kirklin, MD
Over the past 2 decades, mechanical circulatory support devices (MCSD) have developed into a standard
component of the armamentarium of therapies for
advanced heart failure. Almost all of these devices are
currently implanted in patients at imminent risk of
death who are then supported by MCSD therapy as a
bridge to cardiac transplantation. In the current era, a
small proportion of devices are implanted as a “bridge
to recovery” and recently as permanent or “destination”
therapy in a group of patients for whom cardiac transplantation is not an option.1
The MCSD database of the International Society for
Heart and Lung Transplantation (ISHLT) was initiated in
2001 because of the need for multi-institutional, international data that could be accurately collected and
subsequently analyzed to help improve short- and
longer-term outcomes with device therapy and facilitate
the selection of patients best suited for mechanical
circulatory support. The development of the MCSD
Database has been guided since its inception by an
international steering committee composed of representatives of mechanical circulatory support centers,
government, and industry (Appendix 1). This analysis
constitutes the second annual ISHLT MCSD Database
Report.
METHODS
All centers world-wide known to perform MCSD implantation received an invitation to participate in the
From the International Society for Heart and Lung Transplantation,
Addison, Texas.
Submitted August 6, 2004; revised August 6, 2004; accepted August
6, 2004.
All of the figures and tables from this report, and a more comprehensive set of Registry slides are available at www.ishlt.org/
registries/.
Reprint requests: Mario C. Deng, MD, FACC, FESC, Director of
Cardiac Transplantation Research, Division of Cardiology, Department of Medicine, College of Physicians and Surgeons, Columbia
University, New York Presbyterian Hospital, Milstein Hospital Building, Room 5– 435, 177 Fort Washington Avenue, New York, NY
10032. E-mail: [email protected]
J Heart Lung Transplant 2004;23:1027–34.
Copyright © 2004 by the International Society for Heart and Lung
Transplantation. 1053-2498/04/$–see front matter. doi:10.1016/
j.healun.2004.08.001
MCSD data collection process in December 2001. Centers that have submitted data as of May 31, 2004, are
listed in Appendix 2. The date of primary implant
ranges from January 1, 2002, through May 31, 2004.
The last date of follow-up for this analysis was May 31,
2004.
Survival data are reported using the Kaplan-Meier
method as well as parametric survival analysis. Risk
factors were investigated using multivariable analysis in
the hazard function domain. The variables considered
for the multivariable analysis are listed in Appendix 3.
Where appropriate, nomograms are presented as the
mathematical solutions to the multivariable equation.
Because this database currently collects data on a
voluntary basis, the analyses presented are based on
voluntary data submission and, therefore, must be
considered preliminary and not comprehensive.
RESULTS
Patient Characteristics
Data were collected on 413 patients who received mechanical circulatory support between January 2002, and
May 2004. The basic patient characteristics at the time of
implantation are listed in Tables 1 and 2. It is of interest
that 28% of patients had undergone previous cardiac
operations and nearly 10% of patients received MCSD
support concurrent with other cardiac surgery. Almost all
patients received isolated left ventricular support, usually
with a device capable of chronic support (Table 3). The
cardiac diagnosis at time of MCSD implant was ischemic
heart disease in 41%, dilated cardiomyopathy in 50%, and
congenital heart disease in 0.5%. The intended use (intent
to treat) of the device for each patient is indicated in Table
4. The severely ill condition of this patient population is
supported by the finding that 34% of patients required
mechanical ventilatory support before implant, and 6%
Table 1. Continuous Patient Characteristics at Hospital Admission
Measurement
Age at admission
Weight (kg) at
admission
BSA at
admission
Mean
50.27
81.79
1.96
Minimum
10
7
1.28
Maximum
79
SE
0.68
165.7
0.93
2.57
0.01
BSA, body surface area; SE, standard error.
1027
1028
Deng et al.
The Journal of Heart and Lung Transplantation
September 2004
Table 2. Categorical Patient Characteristics at the Time of Implantation
Gender: Male
ABO
Cardiac arrest
Previous Cardiac surgery
Concomitant surgical procedure
Diabetes
Prior CVA/stroke
Carotid artery disease
In ICU
On ventilator
IABP within 30 days of implant
Other mechanical circulatory support device
Inability to wean from CPB
Hemodialysis/ultrafiltration
Acute Myocardial Infarction
Body temperature ⬎ 38.5 C
Cardiac rhythm
QRS duration ⬎ 0.12 msec
NYHA class
A
AB
B
O
Aortic valve replacement/repair
Aortic valve replacement/repair ⫹ CABG
CABG
Congenital cardiac surgery
Mitral valve replacement/repair
Mitral valve replacement/repair ⫹ CABG
Other
Insulin dependent
Oral agents
Abiomed BVS
Biomedicus
ECMO
Tandem Heart
Other
Atrial fib
Paced
Sinus
Other
III
IV
Elective implant
No. of Patients
333
160
13
49
178
43
116
13
1
18
5
4
3
75
38
55
20
19
319
121
155
15
5
7
6
8
26
20
91
27
41
65
233
35
151
25
352
194
% of all Patients
80.6
38.7
3.2
11.9
43.1
10.4
28.1
3.1
0.2
4.3
1.2
0.9
0.7
18.2
9.2
13.3
4.8
4.6
77.2
29.2
37.5
3.6
1.2
1.6
1.5
1.9
6.3
4.8
22.0
6.5
9.9
15.7
56.4
8.5
36.6
6.1
85.2
47.0
CABG, Coronary artery bypass grafting; CPB, Cardiopulmonary bypass; CVA, cerebrovascular accident; ECMO, extracorporeal membrane oxygenation; IABP,
Intra-aortic balloon pump; ICU, intensive care unit; NYHA, New York Heart Association.
required dialysis or ultra-filtration. A recent cardiac arrest
was reported in 10% of patients.
Hemodynamic Data
The hemodynamic data before and after implant are listed
in Table 5. As expected, MCSD therapy was highly effective in reducing capillary wedge pressure and pulmonary
artery pressure, and in increasing cardiac output.
Survival
Among the 413 patients who received an implant and
had follow-up information, there were 105 reported
deaths. The overall survival (censored at transplant)
was 84% at 1 month, 68% at 6 months, and 55% at 12
Table 3. Primary Device Implant
LVAD (alone)
Pulsatile flow, chronic device
Continuous flow, chronic device
Not specified
LVAD ⫹ RVAD
LVAD: Pulsatile flow, chronic device
LVAD: Continuous flow, chronic device
LVAD: Not specified
RVAD: Pulsatile flow, chronic device
RVAD: Pulsatile flow, temporary device
RVAD: Continuous flow, temporary device
RVAD: Not specified
Total
339
303
27
9
74
69
1
4
44
21
8
1
413
LVAD, left ventricular assist device; RVAD, right ventricular assist device.
The Journal of Heart and Lung Transplantation
Volume 23, Number 9
Deng et al.
1029
Table 4. Intention to Treat
No. of % of all
Patients Patients
312
75.5
24
5.8
advanced age
19
4.6
co-morbidity
12
2.9
fixed pulmonary hypertension
3
0.7
contraindication to
1
0.2
7
1.7
Category
Bridge to transplant
Bridge to recovery
Destination therapy,
Destination therapy,
Destination therapy,
Destination therapy,
immunotherapy
Not specified
months (Figure 1). The hazard function (instantaneous
risk) for death was highest immediately after implant,
with a rapidly falling early phase of risk that merged
with a constant hazard at about 2 months following
implant. The major reported causes of death are listed
in Table 6. Multiple organ failure and peri-operative
hemorrhage were the most frequently cited causes of
mortality.
A multivariable analysis in the hazard function domain of the available data supplied by the participating
institutions identified risk factors for the early phase of
hazard as well as the constant phase (Figure 1). The risk
factors identified for death are listed in Table 7. The
need for biventricular support (likely indicating the
severity of pre-implant right-sided heart failure) was the
Figure 1. Survival curve and accompanying hazard function for the
413 patients reported to the registry. The black dots and the
accompanying standard error bars represent the Kaplan-Meier survival
estimates. The accompanying solid line with its 70% confidence limits
(dashed lines) is the parametric survival curve. The lower solid line and
its accompanying 70% confidence limits represent the hazard function
(instantaneous risk) for death after device implantation. Percent
survival is indicated on the left vertical axis and the hazard function
units are displayed on the right vertical axis. The numbers in
parentheses indicate the number of patients with available follow-up at
the designated time point. ISHLT/MCSD, International Society for Heart
and Lung Transplantation/Mechanical Circulatory Support Device
Database.
Table 5. Hemodynamic Characteristics of Patients Prior to and 24 hours after MCSD Implantation
Time
Most recent pre-implant
24 hours post-implant
Label
Arterial pressure - systolic (mm Hg)
Arterial pressure - diastolic (mm Hg)
Central venous pressure (mm Hg)
PA pressure - systolic (mm Hg)
PA pressure - diastolic (mm Hg)
PA pressure - mean (mm Hg)
PCW (mm Hg)
Cardiac Output (L/min)
Cardiac Index (L/min/m2)
PVR (wood units)
LVEF (%)
LVEDD (cm)
LVESD (cm)
Peak VO2 (ml/kg/min)
Arterial pressure - systolic (mm Hg)
Arterial pressure - diastolic (mm Hg)
Central venous pressure (mm Hg)
PA pressure - systolic (mm Hg)
PA pressure - diastolic (mm Hg)
PA pressure - mean (mm Hg)
PCW (mm Hg)
Cardiac Output (L/min)
Cardiac Index (L/min/m2)
PVR (wood units)
No.
349
349
312
331
331
331
282
319
319
268
344
247
181
62
333
333
324
294
294
294
148
265
265
138
Mean
97.89
58.63
13.68
49.62
25.77
33.70
24.32
4.09
2.09
2.62
17.22
24.82
23.43
11.96
115.05
58.92
14.38
35.69
18.71
24.36
13.92
5.72
2.92
1.80
SE
0.91
0.67
0.38
0.84
0.44
0.53
0.54
0.08
0.04
0.15
0.40
1.81
1.99
0.46
1.20
0.67
0.29
0.63
0.34
0.40
0.50
0.10
0.05
0.10
LVEDD, left ventricular end diastolic dimension; LVEF, left ventricular ejection fraction; LVESD, left ventricular end systolic dimension; MCSD, mechanical circulatory
support device; PA, pulmonary arterial; PCW, pulmonary capillary wedge; PVR, pulmonary vascular resistance; SE, standard error
1030
Deng et al.
The Journal of Heart and Lung Transplantation
September 2004
Table 6. Major Causes of Death
N ⫽ 105 (%)
28 (27)
17 (16)
11 (10)
10 (10)
7 (7)
23 (22)
9 (9)
Cause
Multiple organ failure
Hemorrhage
Cardiovascular
Stroke
Infection
Other
Unspecified
major factor associated with early mortality. The poor
overall survival in patients who required biventricular
support is depicted in Figure 2. The interaction between risk factors for biventricular support and worsening pre-implant renal dysfunction is depicted in Figure 3.
Recovery
Survival to explantation of the device because of cardiac recovery was reported in 18 of the 413 patients
(Table 8). There appeared to be a low but constant
likelihood of device removal secondary to recovery
during the first 12 months after MCSD implantation
(Figure 4).
Bridge to Cardiac Transplantation
During the follow-up of this patient cohort, 164 of the
413 patients (40%) underwent cardiac transplantation
(Table 8). The likelihood of transplantation was greatest
between the first and fourth month following device
implantation (Figure 5), with a gradually decreasing
likelihood thereafter. The time-related rates of death,
transplantation, and explantation because of recovery
are depicted in Figure 6.
The markedly inferior likelihood of receiving a heart
transplant following biventricular support compared
with isolated left ventricular support in this experience
is illustrated by the competing outcomes curves depicted in Figures 7 and 8. Biventricular support resulted
in a nearly 2-fold higher mortality within 6 months and
a 25% reduction in the likelihood of transplantation.
Figure 2. Stratified actuarial survival depiction for patients receiving
LVAD support only compared with those requiring both LVAD and RVAD
at the same procedure. The standard error bars are indicated in each
curve. ISHLT/MCSD, International Society for Heart and Lung Transplantation/Mechanical Circulatory Support Device Database; LVAD, left
ventricular assist device; RVAD, right ventricular assist device.
Adverse Events
A total of 1,081 post-implantation adverse events were
reported in 305 (71%) patients, corresponding to 2.5
events per patient. Infection and bleeding were the 2
most common complications (Table 9), and their cumulative frequency over time is depicted in Figure 9.
A variety of events were reported that relate to device
malfunction, and these are listed in Table 10. The
hazard function for such events shows a high early
Table 7. Risk Factors for Death after Device Implant
Risk Factor
Early phase of hazard
Blood type: AB
Diagnosis other than cardiomyopathy
BUN at implant
Concurrent placement of RVAD
Constant phase of hazard
Older age
Gender: female
Relative risk
p-Value
4.7
0.004
3.5
0.001
1.9 (20 vs 120)
0.04
7.4
⬍0.0001
2.7 (30 vs 60)
2.8
*Patients are censored at transplant
BUN, blood urea nitrogen; RVAD, right ventricular assist device.
0.02
0.002
Figure 3. Solution to the multivariable risk model for death, depicting the
impact of increasing levels of BUN (blood urea nitrogen) at implant, on 3
months survival with LVAD (left ventricular assist device) alone, or LVAD
plus RVAD (right ventricular assist device). The other risk factors in the
model were set in this depiction to include blood group O and diagnosis of
ischemic cardiomyopathy. . ISHLT/MCSD, International Society for Heart
and Lung Transplantation/Mechanical Circulatory Support Device
Database.
The Journal of Heart and Lung Transplantation
Volume 23, Number 9
Deng et al.
1031
Table 8. ISHLT/MCSD Registry January 2002 - May 2004, n ⫽ 413
Reason for
Implant
Bridge to
transplant
Bridge to
recovery
Destination
Other
Unknown
Total
Death
before
transplant
Transplant
Explantrecovery
n
n
%
n
%
n
%
312
79
25
145
46
8
6
24
35
7
35
413
7
10
2
7
105
29
29
29
20
25
2
2
0
15
164
8
6
–
43
40
8
0
2
0
18
66
–
29
–
4
ISHLT/MCSD, International Society for Heart and Lung Transplantation/ Mechanical Circulatory Support Device
hazard function followed by a lower but gradually
increasing risk over the ensuing 12 months (Figure 10).
DISCUSSION
The rapid evolution of MCSD therapy for advanced
heart failure has stimulated intense interest in the
development of national and international registries
dedicated to the improvement of circulatory assist
devices and better patient outcomes.2–5 During the first
2.5 years that have followed since the initiation of data
collection, the ISHLT MCSD Database has generated
useful information about outcomes after this therapy.
Perhaps most importantly, however, this analysis provides a glimpse at the power of this registry in generating risk stratification for various patient sub-sets,
tracking adverse events with a variety of devices, and
looking at outcome indicators in a time-related analysis.
As the efficacy and safety of MCSD therapy continues to
Figure 4. Parametric and Kaplan-Meier depiction of freedom from
device explantation as a result of cardiac recovery (upper curve) and
the associated hazard function (lower curve). The depiction is as in
Figure 1. ISHLT/MCSD, International Society for Heart and Lung
Transplantation/Mechanical Circulatory Support Device Database.
Figure 5. Actuarial and parametric depiction of freedom from transplantation after device implant. The hazard function with its 70%
confidence limits is also shown. The depiction is as in Figure
1.ISHLT/MCSD, International Society for Heart and Lung Transplantation/Mechanical Circulatory Support Device Database.
improve, this registry data and its analyses could play a
vital role in guiding in the selection of MCSD therapy,
transplantation, medical therapy, or other surgical procedures for individual patients with advanced heart
failure. As we begin to collect additional information on
quality of life, costs, and functional outcomes, additional insightful analyses will be possible.
As we enter an era of increasing application of
destination MCSD therapy with the need for accurate
longitudinal data, it is noteworthy that the ISHLT has
provided the leadership in generating the only national
or international registry of this type that focuses on
mechanical circulatory support. With the short period
of available follow-up, the data included in this report
Figure 6. Hazard function for the events of transplantation, death, and
explant due to recovery. ISHLT/MCSD, International Society for Heart
and Lung Transplantation/Mechanical Circulatory Support Device
Database.
1032
Deng et al.
The Journal of Heart and Lung Transplantation
September 2004
Table 9. Summary of Post-Implantation Patient-Related Events
Figure 7. Competing outcomes analysis for the mutually exclusive
outcome events that are indicated in this depiction. At any point in
time, the sum of the probabilities of each event equals 100%. This
depiction is for patients receiving left ventricular assist device (LVAD)
support only. MCSD, Mechanical Circulatory Support Device Database.
are short-term observations; however, with time the
registry will continue to capture a more complete
picture of the results of MCSD therapy.
It is also important to bear in mind the limitations of
this dataset, which are primarily those of voluntary
submission of data. Thus, follow-up is only available
through the final data forms that have been supplied on
each patient. In the future, at least in the United States,
all patients who receive destination therapy and many
who receive bridging devices will be required to submit
complete information to a national registry such as this.
Mandatory complete data submission and thoughtful
Event
No. of Patients % of all Patients
Infection
134
32.5
Bleeding
115
27.8
Arrhythmia
100
24.2
Renal dysfunction
85
20.6
Respiratory dysfunction
66
16.0
Neurological dysfunction
58
14.0
Right ventricular dysfunction
44
10.7
Hepatic dysfunction
30
7.2
Cardiac tamponade
22
5.3
Thrombotic vascular complication
18
4.4
Hematoma
10
2.4
Pleural effusion
9
2.2
Internal organ compromise
5
1.2
Pacemaker implanted
2
0.5
selection of data elements for collection would provide
a unique opportunity to generate the kinds of analyses
that could be truly helpful in facilitating improvements
in existing devices, evaluating new devices, and optimizing long-term patient outcomes.
Figure 9. Cumulative average frequency per patient of the indicated
adverse events following device implant. ISHLT/MCSD, International
Society for Heart and Lung Transplantation/Mechanical Circulatory
Support Device.
Table 10. Device Malfunction
Figure 8. Competing outcomes analysis for the mutually exclusive
outcome events that are indicated in this depiction. At any point in
time, the sum of the probabilities of each event equals 100%. This
depiction is for patients receiving both left and right ventricular assist
devices at the implant operation. LVAD, left ventricular assist device;
RVAD, right ventricular assist device; MCSD, Mechanical Circulatory
Support Device Database.
Event
Controller
Pump/pump drive unit
Conduit/graft inflow
Conduit/graft outflow
Valve/valved conduit inflow
Battery
Implanted battery
Percutaneous lead/drive line
Other
Total
No. of Events
16
7
5
2
2
1
1
1
19
54
The Journal of Heart and Lung Transplantation
Volume 23, Number 9
Figure 10. Actuarial and parametric freedom from device malfunction
with the accompanying hazard function. Depiction is as in Figure
1.ISHLT/MCSD, International Society for Heart and Lung Transplantation/Mechanical Circulatory Support Device.
REFERENCES
1. Rose EA, Gelijns AC, Moskowitz AJ, et al, for the Randomized Evaluation of Mechanical Assistance for the Treatment
of Congestive Heart Failure (REMATCH) Study Group.
Long-term use of a left ventricular assist device for endstage heart failure. N Engl J Med 2001;345:1435– 43.
2. Stevenson LW, Kormos RL, Bourge RC, et al. Mechanical
cardiac support 2000: current applications and future trial
design: June 15–16, 2000 Bethesda, Maryland. JAMA 2001;
37:340 –70.
3. Deng MC. The Mechanical Circulatory Support Device
Database of the International Society for Heart and Lung
Transplantation. Curr Opin Cardiol 2003;18:147–52.
4. Deng MC, Edwards LB, Hertz MI, Rowe AW, Kormos RL.
Mechanical Circulatory Support Device Database of the
International Society for Heart and Lung Transplantation:
first annual report—2003. J Heart Lung Transplant 2003;
22:653– 62.
5. Deng MC, Young JB, Stevenson LW, et al, on behalf of the
Board of Directors of the International Society for Heart
and Lung Transplantation (ISHLT). Destination Mechanical
Circulatory Support–Proposal for Clinical Standards.
J Heart Lung Transplant 2003;22:365–9.
APPENDIX 1. Current MCSD Database Steering
Committee
Jack Copeland, Tucson, USA
Walter Dembitsky, American Society of Artificial Internal Organs
Mario Deng, New York, USA
Robert Dowling, Louisville, USA
Gilles Dreyfus, London, England
Leah Edwards, United Network for Organ Sharing, USA
Ali El-Banayosy, Oeynhausen, Germany
Bruce Ferguson, Society of Thoracic Surgeons, USA
Charles Frazier, Houston, USA
Paul Hendry, Ottowa, Canada
Robert Higgins, Chicago, USA
Douglas Hillier, WorldHeart
Deng et al.
1033
Manfred Hummel, Berlin, Germany
Sharon Hunt, Palo Alto, USA
Berkeley Keck, United Network for Organ Sharing, USA
Robert Kormos, Pittsburgh, USA
Steven Large, Cambridge, England
Daniel Loisance, Paris, France
James Long, Salt Lake City, USA
Paul Mather, Philadelphia, USA
Hikaru Matsuda, Osaka, Japan
Patrick McCarthy, Cleveland, USA
Donald Middlebrook, Thoratec, USA
Jaime Moriguchi, Los Angeles, USA
Frank Pagani, Ann Arbor, USA
Alain Pavie, Paris, France
Peer Portner, Palo Alto, USA
Brano Randovancevic, Houston, USA
Bruno Reichart, Munich, Germany
Robert Robbins, Palo Alto, USA
Eric Rose, New York, USA
Amanda Rowe, International Society for Heart and Lung
Transplantation
Christof Schmid, Muenster, Germany
Stephan Schueler, New Castle, England
Lynne Stevenson, Boston, USA
Guillermo Torre, Houston, USA
Cliff van Meter, New Orleans, USA
George Wieselthaler, Vienna, Austria
APPENDIX 2. Centers Submitting to MCSD Database (as
of May 31, 2004).
Country
Austria
Belgium
Center
University of Vienna
Cliniques Universitaires St. Luc
University Hospital Gasthuisberg/Catholic University of
Leuven
Canada
Ottawa Heart Instiute
Quebec Heart Instiute - Laval Hospital
France
C.H.U. Henri Mondor - Univ Paris XII
Germany
Medizinische Einrichtungen der University Nuremberg
Herz-und Diabetesentrum Nordrhein-Westfal
Chirurgische. Universitaetsklinik/University of Freiburg
Israel
Sheba Medical Center
Italy
Istituto Clinico Humanitas
Niguarda CA Granda Hospital
Singapore
National Heart Centre
United States University of Alabama Hospital
Washington Hospital Center
St. Luke’s Hospital (Jacksonville)
University of Iowa Hospitals and Clinics
Rush-Presbyterian/St. Luke’s Medical Center
Advocate Christ Medical Center
Lutheran Heart Center
Jewish Hospital
Oschner Medical Institutes
New England Medical Center
University of Michigan Medical Center
Barnes Jewish Hospital
Carolinas Medical Center
1034
Deng et al.
Country
Center
Duke University Medical Center
Bryan LGH Medical Center East
Newark Beth Israel Medical Center
Montefiore Medical Center
Columbia Presbyterian Medical Center
Ohio State University Hospital
Oregon Health Sciences & University Hospital
Hershey Medical Center
Thomas Jefferson University Hospital
Thoracic Transplant Services
Vanderbilt Transplant Center
Seton Medical Center
Medical City Dallas Hospital
Baylor University Medical Center
The Methodist Hospital (Houston)
LDS Hospital
University of Utah Medical Center
Inova Fairfax Hospital
MCV Hospitals
Sacred Heart Medical Center
University of Wisconsin Hospital
St. Luke’s Medical Center (Milwaukee)
APPENDIX 3. Variables Entered into the Risk Factor
Analysis for Death
Patient and Device Information
Age
BSA
Gender
Blood group (ABO)
Diagnosis
Pre-Implant Conditions
Cardiac arrest ⬍ 24 hours pre-implant
Previous Cardiac Surgery
Diabetes
CVA/Stroke
Carotid artery disease
The Journal of Heart and Lung Transplantation
September 2004
In ICU
On ventilator
Inability to wean from CPB
Hemodialysis/ultrafiltration
Acute Myocardial Infarction
Body temperature ⬎ 38.5° C
Cardiac rhythm: Sinus
QRS duration ⬎ 0.120 msec
NYHA Function Class
Implant election
Intention to Treat
Device category
Pulsatile
Chronic
RVAD
Pre-Implant Laboratory Data
Blood Urea Nitrogen
Creatinine
Sodium
INR
White Blood Cells
Platelets
Hematocrit
Pre-Implant Hemodynamics
Arterial pressure
Central venous pressure
Pulmonary artery pressure
Pulmonary capillary wedge
Cardiac output
Cardiac index
PVR
Left ventricular ejection fraction
Left ventricular end diastolic dimension
Left ventricular end systolic dimension
Peak VO2
BSA, body surface area; CPB, Cardiopulmonary bypass; CVA, cerebrovascular
accident; ICU, intensive care unit; INR, International Normalized Ratio; NYHA,
New York Heart Association; PVR, pulmonary vascular resistance; RVAD, right
ventricular assist device