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A Decade of Experience With More Than 300
Continuous-Flow Left Ventricular Assist Devices
at a Single Center
Ranjit John MD, Peter Eckman MD, Christopher T Holley MD,
Samit Roy MS, Laura Harvey MD, Kaustav Majumdar MD,
Sara Shumway MD, Kenneth Liao MD, Ranjit John MD
AATS 2015
Seattle, WA
2015 Faculty Disclosure Slide
All authors:
• Dr Ranjit John discloses research
grants from Thoratec and HeartWare
• Dr Peter Eckman discloses Thoratec
grant support and consulting
Introduction
• LVADs have become increasingly
common for treatment for end-stage
heart failure.
– Approved by FDA as both destination
therapy and as a bridge to cardiac
transplantation
• CF-LVADs have superior durability and
excellent clinical outcomes compared
with previous generation of pulsatileflow devices.
Background
• Previously unseen risks of GI bleeding,
hemolysis and pump thrombosis with
continuous-flow LVADS.
• Clinical trials are underway on the next
generation of LVADS such as the HM
III and the MVAD.
Objectives
• Evaluate clinical outcomes with the HM
II LVAD including adverse effects and
survival both short and long term at a
single center.
• Examine trends in clinical outcomes
with the HM II LVAD over a decade of
experience.
HeartMate II
•
•
•
•
Electrically powered
Percutaneous driveline
Flow rate 3-10L/min
FDA approved
– Bridge to
transplantation
– Destination Therapy
• Extensive clinical
experience
Methods
• Single center retrospective analysis of
278 patients receiving 302 HM II LVADs
between June 2005 and June 2014.
11 patients excluded who received HM II
for failed HM XVE LVAD
• Remaining 267 patients divided into 3
groups of 89 each (Groups 1, 2 and 3).
Methods
• Standard statistical analysis
• 2-sided significance level of 0.05.
• For between-group comparisons, we
used a 2-sample t test for continuous
variables and a chi-square test for
categorical variables.
• Survival analyses were based on the
Kaplan-Meier method
Results
Demographics/
Preoperative Labs
BTT
Postop Hospitalization (days)
Male
Age (years)
BMI
INTERMACS score
Ischemic HF
CABG
Hypertension
COPD
Diabetes
CKD
CAD
History of MI
PTCA/PCI
Creatinine (mg/dL)
AST (U/L)
ALT (U/L)
Bilirubin (mg/dL)
Total Cohort (n=267)
Group 1 (n=89)
Group 2 (n=89)
Group 3 (n=89)
[n (%) or mean ± SD]
[n (%) or mean ± SD]
[n (%) or mean ± SD]
[n (%) or mean ± SD]
p-value
(1v2v3)
209 (78.9%)
19.2 ± 12.8
214 (81.4%)
57 ± 14
29.2 ± 7.6
3.8 ± 1.6
153 (58.0%)
84 (32.1%)
114 (43.5%)
31 (11.9%)
97 (37.0%)
91 (34.7%)
165 (63.0%)
110 (42.2%)
71 (27.2%)
1.36 ± 0.55
78 (88.6%)
21.5 ± 16.1
63 (71.6%)
55 ± 14
28.7 ± 6.2
3.7 ± 1.6
52 (59.1%)
24 (27.9%)
35 (40.7%)
9 (10.6%)
22 (25.6%)
25 (29.1%)
55 (64.0%)
40 (46.5%)
25 (29.1%)
1.41 ± 0.66
73 (83.0%)
18.6 ± 11.1
70 (80.5%)
56 ± 14
28.4 ± 5.4
4.2 ± 1.6
50 (56.2%)
28 (31.8%)
39 (44.3%)
7 (8.1%)
31 (35.2%)
35 (39.8%)
51 (58.0%)
34 (39.1%)
24 (27.6%)
1.28 ± 0.47
58 (65.2%)
17.4 ± 10.2
81 (92.1%)
60 ± 14
30.3 ± 9.9
3.4 ± 1.4
51 (58.6%)
32 (36.4%)
40 (45.5%)
15 (17.1%)
44 (50.0%)
31 (35.2%)
59 (67.1%)
36 (40.9%)
22 (25.0%)
1.39 ± 0.55
<0.001
0.10
0.002
0.027
0.22
0.001
0.92
0.49
0.80
0.17
0.004
0.33
0.45
0.59
0.83
0.42
(n=176)
(n=38)
(n=50)
(n=88)
55.0 ± 91.8
63.2 ± 90.2
42.3 ± 25.1
58.8 ± 115.4
(n=168)
(n=38)
(n=49)
(n=81)
65.0 ± 146.2
66.7 ± 109.0
38.5 ± 33.2
80.6 ± 195.0
(n=169)
(n=38)
(n=50)
(n=81)
1.42 ± 1.49
1.89 ± 2.65
1.19 ± 0.88
1.34 ± 0.91
(n=169)
(n=38)
(n=50)
(n=81)
0.51
0.28
0.072
Overall Survival
30 Day
94%
1 year
77%
2 year
65%
5 year
48%
Survival by Group/Era
P = 0.003
Actuarial Survival By Group/Era
Survival
Total Cohort
Group 1
Group 2
Group 3
(mean survival)
(n=267) [95% CI]
(n=89) [95% CI]
(n=89) [95% CI]
(n=89) [95% CI]
94%
94%
93%
94%
[90%-96%]
[87%-98%]
[86%-97%]
[87%-98%]
84%
77%
90%
84%
[79%-88%]
[67%-85%]
[81%-95%]
[74%-90%]
77%
64%
88%
77%
[71%-81%]
[53%-74%]
[78%-93%]
[66%-85%]
65%
48%
76%
73%
[58%-71%]
[35%-59%]
[65%-84%]
[61%-82%]
30 days
6 months
1 year
2 years
Survival by BTT vs. DT
eedom from/Survival numbers [TOTAL COHORT]
30 day
94%
1 year
77%
2 year
65%
Enrollment
BTT
DT
1 year
78%
70%
5 year
48%
2 year
66%
60%
P = 0.48
Complications According to Era of
Implant
Outcomes
Total Cohort
Group 1
Group 2
Group 3
p-value
n(%) or mean ± SD
(n=267)
(n=89)
(n=89)
(n=89)
(1v2v3)
Stroke
GI Bleed
Driveline infection
Pump exchange (any reason)
Hemolysis
Pump thrombus
Pts. undergoing transplant
Days to transplant
42 (16.5%)
67 (26.1%)
60 (23.4%)
25 (9.4%)
37 (13.9%)
18 (6.8%)
74 (28.4%)
458 ± 353
11 (13.3%)
19 (22.9%)
25 (30.1%)
4 (4.5%)
5 (5.6%)
1 (1.1%)
51 (58.0%)
406 ± 376
17 (19.5%)
25 (28.7%)
27 (31.0%)
11 (12.4%)
17 (19.1%)
8 (9.0%)
19 (21.6%)
591 ± 288
14 (16.5%)
23 (26.4%)
8 (9.2%)
10 (11.2%)
15 (16.9%)
9 (10.1%)
4 (4.7%)
344 ± 176
0.54
0.68
0.001
0.16
0.020
0.023
<0.001
0.090
Event Rates for Complications
Complications per
Person-year
Stroke
GI Bleed
Driveline
Infection
Pump Exchange
Pump Hemolysis
Total Cohort
Group 1
Group 2
Group 3
(n=270)
(n=89)
(n=89)
0.092
0.155
0.152
0.083
0.127
0.220
0.057
0.088
0.027
0.036
(n=89)
p-value
1v2
p-value
1v3
p-value
2v3
0.083
0.132
0.144
0.126
0.250
0.086
1
0.90
0.13
0.31
0.032
0.015
0.27
0.033
0.19
0.055
0.090
0.103
0.164
0.25
0.059
0.023
0.002
0.16
0.10
Freedom from Stroke
1 year
88%
3 year
80%
5 year
71%
1 year
84%
3 year
68%
5 year
52%
1 year
83%
3 year
65%
5 year
49%
1 year
95%
3 year
84%
5 year
72%
1 year
90%
3 year
80%
5 year
66%
Stroke
GI Bleed
Driveline
1 year
88%
84%
83%
3 year
80%
68%
65%
Freedom from 1GI
yearbleed
3 year 5 year
88%
80%
71%
1 year
84%
3 year
68%
5 year
52%
1 year
83%
3 year
65%
5 year
49%
1 year
95%
3 year
84%
5 year
72%
1 year
90%
3 year
80%
5 year
66%
Stroke
GI Bleed
Driveline
1 year
88%
84%
83%
3 year
80%
68%
65%
1 year
84%
3 year
68%
5 year
52%
1 year
83%
3 year
65%
5 year
49%
1 year
95%
3 year
84%
5 year
72%
1 year
90%
3 year
80%
5 year
66%
Freedom from Driveline Infection
Stroke
GI Bleed
Driveline
1 year
88%
84%
83%
3
1 year
95%
3 year
84%
5 year
72%
1 year
90%
3 year
80%
5 year
66%
Freedom from Hemolysis
Stroke
GI Bleed
Driveline
Infection
Pump Exchange
Pump
Hemolysis
1 year
88%
84%
83%
3
8
6
6
95%
90%
8
8
1 year
83%
3 year
65%
5 year
49%
1 year
95%
3 year
84%
5 year
72%
1 year
90%
3 year
80%
5 year
66%
Freedom from Pump exchange
Stroke
GI Bleed
Driveline
Infection
Pump Exchange
Pump
Hemolysis
1 year
88%
84%
83%
95%
90%
Strengths and Limitations
• Retrospective study
• Large single center with 5 year follow up
• Fairly consistent management
strategies
• Changes in clinical management not
reflected in this study, such as
anticoagulation strategy, echo ramp,
LDH screening, driveline velour burying
technique.
Conclusions
• Excellent short (94%- 30 day), mid-term
(77% - 1 year) and long term survival (48%
- 5 year)
• Increasing use as DT LVAD
• More sicker patients in recent years
• Improvement in survival in later groups
• Increased pump hemolysis, pump
exchange and GI bleed in recent era
• Reduced driveline infection in recent era
Where Do We Go From Here
• HM II LVAD has set a high standard for
survival and adverse events
• HM III and the MVAD are starting
clinical trials
• Role in less sick heart failure patients ?
• Clinical trial of LVADs vs. Heart
transplantation ?