A Case History of Hypertension in Pregnancy Max Brinsmead MB BS PhD April 2014.
· Web viewe. Hypertension is defined as a history of drug-treated systemic hypertension, reported...
Transcript of · Web viewe. Hypertension is defined as a history of drug-treated systemic hypertension, reported...
SUPPLEMENTAL ONLINE-ONLY MATERIAL
Table E1. Pre-Implant Incremental Risk Factors for Death on HeartMate II Support
Factor Coefficient ± SE P Reliability (%)a
Early Phase
History of valve surgery 1.29 ± 0.52 .01 76
History of CABG 1.33 ± 0.51 .009 76
Lower albuminb 1.79 ± 0.38 <.0001 62
Lower GFRc -1.59 ± 0.64 .01 66
Higher mean arterial blood pressure at implantd
0.16 ± 0.071 .03 52
Constant Phase
History of hypertensione 0.75 ± 0.32 .02 65
Earlier date of implantf -1.76 ± 0.49 .0004 90
a. Percent of times variable appeared in 500 bootstrap models
b. (Albumin/3)2, inverse squared transformation
c. (GFR), logarithmic transformation
d. (Mean arterial blood pressure/25)2, squared transformation
e. Hypertension is defined as a history of drug-treated systemic hypertension, reported in the patient’s
complete history and physical evaluation when they are being considered for transplant or VAD implant.
This variable was deactivated in the UNOS form in 2015. f. (Date of implant/6), logarithmic transformation
Key: CABG, coronary artery bypass grafting; GFR, glomerular filtration rate; SE, standard error
1
Table E2. Adverse Events during HeartMate II Support
Adverse Event Patients (n) Events (n)
Dialysis 46 46
Stroke (ischemic) 29 31
Intracranial hemorrhage 22 25
Device exchange 16 16
Pump thrombosis
Confirmed 12 12
Suspected 15 15
Hemolysis 30 32
Infection
Blood 78 78
Pump pocket 18 18
Driveline 61 61
Tracheostomy 53 53
Pre-discharge reoperation
For bleeding 50 50
For tamponade 13 13
Gastrointestinal bleed 60 60
2
Table E3. Incremental Risk Factors for Dialysis on HeartMate II Support
Factor Coefficient ± SE P Reliability (%)a
Early Phase
Higher pulmonary systolic pressureb 2.09 ± 0.71 .005 95
History of CABG 0.97 ± 0.34 .005 50
Lower albuminc 1.57 ± 0.42 .0003 65
Higher creatinined 1.06 ± 0.48 .03 73
Higher bilirubin 0.28 ± 0.071 .0002 55
Late Phase
Higher creatinined 9.41 ± 3.34 .005 66
Longer pre-implant hospital stay 0.077 ± 0.029 .01 63
a. Percent of times variable appeared in 500 bootstrap models
b. (Pulmonary artery pressure-systolic), logarithmic transformation
c. (Albumin/3)2, inverse squared transformation
d. (Creatinine), logarithmic transformation
Key: CABG, coronary artery bypass grafting; SE, standard error
3
Table E4. Incremental Risk Factors for Intracranial Hemorrhage on HeartMate II Support
Risk Factor Coefficient ± SE P Reliability (%)a
Early Phase
No significant risk factors
Late Phase
Higher MELD scoreb -4.26 ± 1.92 .03 54
a. Percent of times variable appeared in 500 bootstrap models.
b. (12/MELD), inverse transformation
Key: MELD, Model for End-Stage Liver Disease; SE, standard error
4
FIGURE LEGENDS
Figure E1. Illustrations of strength of risk factors for death during HeartMate II support. A, Survival
stratified by prior coronary artery bypass grafting (CABG). Each symbol represents a death
positioned according to the Kaplan-Meier estimator; vertical bars represent confidence limits
equivalent to ±1 standard error. Depiction stops at last event. B, Survival stratified by prior valve
surgery. Depiction is as in Figure E1A. C, Effect of albumin on 3-month survival. Nomogram of
multivariable Table E1 with the following risk factors: no history of valve surgery or CABG,
glomerular filtration rate of 65 mL-1·min-1·1.73 m2, mean blood pressure 70 mmHg, history of
hypertension, date of implant June 2010. D, Effect of glomerular filtration rate (GFR) on 3-month
survival. Depiction as in Figure E1C, except albumin is 3.5 g·dL-1. E, Effect of mean arterial blood
pressure on 1-year survival. Depiction as in Figure E1C, except albumin is 3.5 g·dL-1. F, Survival
stratified by history of hypertension. Depiction is as in Figure E1A. G, Effect of date of implant on
1-year survival. Depiction is as in Figure E1C except albumin is 3.5 g·dL-1.
5
6
7
8
Figure E2. Survival stratified by device exchange. Time zero for curves for “Second HeartMate II”
is time of pump exchange. Depiction is as in Figure 1.
9
10
Appendix E1. Variables Considered in the Analyses
Pre–Mechanical Circulatory Support (MCS)
Demographics: Age (y), sex, body surface area (m2), body mass index (kg∙m-2),
height (cm), weight (kg), weight-to-height ratio (kg∙m-1), race
Blood group: A, B, AB, O
Hemodynamics: Pulmonary artery pressure (systolic, mean, diastolic; mmHg),
cardiac index (L∙min-1·m-2), heart rate, systemic blood pressure
(systolic, mean, diastolic, mmHg)
Medical condition: Dilated cardiomyopathy, history of coronary artery disease,
previous myocardial infarction, previous cardiac operation,
coronary artery bypass grafting, implantable cardioverter-
defibrillator, medical condition at time of MCS (intensive care unit
[ICU], in-hospital but not ICU, not hospitalized, home on
ventricular assist device), ventricular tachycardia or fibrillation,
New York Heart Association functional class, hypertension
Noncardiac comorbidity: Albumin (g∙dL-1), blood urea nitrogen (mg∙dL-1), creatinine
(mg∙dL-1), creatinine clearance, glomerular filtration rate
(mL-1·min-1·1.73 m2), MELD score, hematocrit (%), hemoglobin
(g·dL-1), International Normalized Ratio, platelets, sodium, total
bilirubin (mg∙dL-1), smoking, diabetes, alcohol use
11
Echocardiogram: Ejection fraction (%), ventricular function, insufficiency
Hospital length of stay: Admission to implant (days)
INTERMACS: Level 1-6
Strategy: Destination therapy, bridge to transplant/decision
Temporary support: Before HeartMate II: Intra-aortic balloon pump, intravenous
inotropes, ventilator, extracorporeal membrane oxygenation
(ECMO)
Panel reactive antibodies (PRA): Pre-HeartMate II PRA
Experience: Interval from 1/1/2004 to date of MCS
During MCS
Mode of support: ECMO, number of device exchanges
Adverse events: Stroke, intracranial bleed, thrombosis, hemolysis, driveline
infection, pump pocket infection, blood stream infection, dialysis,
tracheostomy, reoperation for bleeding and tamponade
Pre-Transplant
Time: Interval between HeartMate II and transplant
Demographics: Age (y), body surface area (m2), body mass index
12
(kg∙m-2), height (cm), weight (kg), weight-to-height ratio
(kg∙m-1), race
Hemodynamics: Pulmonary artery pressure (systolic, mean, diastolic; mmHg),
cardiac index (L∙min-1·m-2), heart rate, systemic blood pressure
(systolic, mean, diastolic, mmHg), wedge pressure (mmHg),
central venous pressure (mmHg)
Noncardiac comorbidity: Albumin (g∙dL-1), blood urea nitrogen (mg∙dL-1),
creatinine (mg∙dL-1), creatinine clearance, glomerular filtration rate
(mL-1·min-1·1.73 m2), MELD score, hematocrit (%), hemoglobin
(g·dL-1), International Normalized Ratio, platelets, sodium, total
bilirubin (mg∙dL-1), smoking, diabetes, alcohol use
Echocardiogram: Ejection fraction (%), ventricular function, insufficiency
Hospital length of stay: Admission to transplant (days)
Experience: Interval from 1/1/2004 to date of transplant
13