INTERMACS The Interagency Registry for Mechanically Assisted

INTERMACS The Interagency Registry for Mechanically Assisted

SRTR Consensus Conference on Transplant
Program Quality and Surveillance
February 13-15, 2012
INTERMACS
The Interagency Registry for
Mechanically Assisted Circulatory
Support
David C. Naftel, PhD
INTERMACS Co-PI
Director of the DCC
University of Alabama at Birmingham
What is INTERMACS ?
INTERMACS is the United States national
registry for patients who are receiving durable
mechanical circulatory support device therapy
to treat advanced heart failure. This registry
was devised as a joint effort of the National
Heart, Lung and Blood Institute (NHLBI), the
Centers for Medicare and Medicaid Services
(CMS), the Food and Drug Administration
(FDA), clinicians, scientists and industry
representatives.
INTERMACS
Interagency Registry for
Mechanically Assisted Circulatory
Support
NIH funded registry for FDA approved durable
devices
• Data collection began June 23, 2006
• Currently, over 130 hospitals enrolled
• As of February 10, 2012: 6,286 patients entered
INTERMACS: A unique collection of partners
I. Government
NHLBI
FDA
Pre-Market
Post-Market
CMS
OMB
OSMB
JCAHO
II. INTERMACS Structure
UAB (DCC)
Cleveland Clinic Foundation
UNOS (DCR)
Brigham and Women’s Hospital
Subcommittees (8)
Univ of Pittsburgh, Univ of Michigan
US Sites (114)
SeraCare (Blood & Tissue Repository)
III. MCSD Community
US Industry(15)
Foreign Industry
Foreign Sites
Japanese “FDA”
ISHLT
ASAIO
Insurance Companies
Goals of the Registry
• Facilitate the refinement of patient selection to
maximize outcomes with current and new device
options.
• Identify predictors of good outcomes as well as risk
factors for adverse events after device implantation.
• Develop consensus “best practice” guidelines to
improve clinical management by reducing short and
long term complications of MCSD therapy.
• Guide clinical application and evolution of next
generation devices.
• Utilize Registry information to guide improvements
in technology, particularly as next generation
devices evolve.
INTERMACS Printable Forms
2
Eligibility Screen
3
Patient Demographics
Form
Device Information
Implant Form
11
Rehospitalization Form
12
AE Reminder
Device Details
1 Week Followup Form
6
Hemodynamics
Laboratory
Medications
Medical Conditions
Medications
Medical Condition
Medications
Laboratory
Exercise Functions Medical Condition
AE Reminder
Quality of Life
9
6 Month Followup Form
Medications
Laboratory
Exercise Functions Medical Condition
AE Reminder
Quality of Life
10
Chronology of Hospital Time
Medications
Device Parameters
13
AE Neurological Dysfunction
Form
14
AE Device Malfunction Form
15
AE Reminder
3 Month Followup Form
8
Hemodynamics
Device Parameters
Patient Status
AE Infection Form
AE Reminder
1 Month Followup Form
7
Hemodynamics
Laboratory
Blood & Tissue Form
Medical Support Status
Hemodynamics
Medications
Medical Condition Exercise Functions
5
Hemodynamics
Device Parameters
Patient Status
Screening Log
Pre-Implant Form
4
Demographic
Co-morbidities
Laboratory
Quality of Life
1
Discharge Form
Hemodynamics (reduced)
Laboratory
AE Reminder
Bleeding Form
16
Explant Form
17
Death Form
18
Measure of Study Quality
(Study Design, Data Analysis)
INTERMACS
Good Clinical
Trial
Planned (thoughtful) Analyses
OSMB
Medical Review of Adverse Events
Local PI Certification
Data Freeze
Audits
Complete Follow-up
Complete Data
All Cases
Adverse Event Definitions
Inclusion/Exclusion Criteria
Typical Registry
Overall Survival
: June 2006 – September 2010
Adult Primary Implants, Destination Therapy: n=385
100
0.20
n=385, deaths=97
80
0.16
% Survival
0.14
60
0.12
Month % Survival
3 mo
85%
6 mo
76%
12 mo
67%
24 mo
46%
40
20
0.10
0.08
0.06
Hazard
0.04
Event: Death (censored at transplant or explant recovery)
0
0
Pts
at risk: 385
3
250
6
9
12
15
18
Months after Device Implant
148
78
Deaths/Month (Hazard)
0.18
56
42
28
0.02
21
0.00
24
24
17 Figure 8
Overall Survival
: June 2006 – June 2011
Adult Primary LVADs: n=3856
% Survival
Continuous Flow Pump,
n=3278, deaths=509
By Pump Type
% Survival
Month CFP
PFP
3 mo
92% 83%
6 mo
88% 75%
12 mo
83% 66%
24 mo
75% 45%
Pulsatile Flow Pump, n=578,
deaths=207
p < .0001
Event: Death (censored at transplant or explant recovery)
Months after Device Implant
Overall Survival
: June 2006 – June 2011
Adult Primary LVADs VS BiVADs: n=4209
LVADs, n=3856, deaths=716
% Survival
By Device Type
Month
3 mo
6 mo
12 mo
24 mo
Event:
% Survival
LVADs BIVADs
BiVADs, n=353, deaths=126
90% 69%
86% 62%
80% 54%
p < .0001
69% 53%
Death (censored at transplant or explant recovery)
Months after Device Implant
INTERMACS: June 2006 – September 2009: Survival after LVAD Implant
Inclusion Criteria
 Primary Device Implant
 Implant of LVAD alone
 Adults (age ≥ 19 years at implant)
 Implant dates: June 23, 2006 – September 30, 2009
 Follow-up date: September 30, 2009
Study Group
 Patients:
1440
 Patient years:
872.38
 Total deaths with a device in place:
280
 Total heart transplants:
468
 Total device removals due to recovery:
14
INTERMACS: June 2006 – September 2009: Survival After LVAD Implant
Adult Primary Intracorporeal LVADs: 1366
Early
Risk Factor
Female
Age (older)
Previous CABG
Previous Valve Surgery
Dialysis (current)
INR (higher)
Ascites
RVEF: Severe
RA Pressure (higher)
Cardiogenic Shock
BTC or DT
Pulsatile pump
Hazard ratio p-value
1.71
0.04
1.141
0.006
2.71
<0.0001
1.99
0.01
2.45
0.01
1.492
0.003
2.32
0.002
----1.523
0.02
1.98
0.003
---------
Constant
Hazard ratio p-value
----1.131
0.008
--------------------2.33
0.04
--------3.00
0.01
3.02
0.001
1 Hazard ratio denotes the increased risk with a 20 year increase in age
2 Hazard ratio denotes the increased risk with a 1.0 increase in INR
3 Hazard ratio denotes the increased risk of a 10-unit increase in RA pressure
Implants: June 2006 – September 2009: Survival after LVAD Implant
Adult Primary Intracorporeal LVADs: n= 1366
Predicted % Survival
100
Continuous
Intracorporeal
90
80
Pulsatile
Intracorporeal
70
60
50
“Average” Patient
40
30
20
Risk Factor
Constant Phase
Pulsatile pump
Unadjusted
Hazard ratio p-value
12.54
<0.0001
Adjusted
Hazard ratio p-value
3.02
0.001
10
0
0
3
6
9
12
15
18
Months after Device Implant
21
24
Implants: June 2006 – September 2009: Survival after LVAD Implant
Probability of Death by 12 months
Adult Primary Intracorporeal LVADs: n= 1366
60
“Average” Patient
50
40
30
Pulsatile
Intracorporeal
20
10
0
15
Continuous
Intracorporeal
25
35
45
55
Age (years)
65
75
Implants: June 2006 – September 2009: Survival after LVAD Implant
Adult Primary LVAD Pumps: n= 1366
Pre-Implant
Patient 1
Patient 2
Patient 3
Gender
Age (yrs)
Male
50
Male
55
Male
60
History of CABG
History of Valve surgery
History of Dialysis
INR
No
No
No
1.0
No
No
No
1.5
No
No
No
2.0
Device Strategy
Pt Profile: Cardiogenic Shock
BTT
No
BTT
No
BTT
Yes
RA Pressure
RVEF (Severe)
Ascites
12
No
No
18
No
Yes
22
No
Yes
Implants: June 2006 – September 2009: Survival after LVAD Implant
Adult Primary LVAD: Pulsatile Intracorporeal Pumps: n= 470
Predicted % Survival
100
Patient 1
90
80
Patient 2
70
60
Patient 3
50
40
30
20
Predicted Survival
Months Patient 1 Patient 2 Patient 3
12
91%
81%
58%
24
10
0
0
3
84%
6
74%
9
12
50%
15
18
Months after Device Implant
21
24
Implants: June 2006 – September 2009: Survival after LVAD Implant
Adult Primary LVAD: Continuous Intracorporeal Pumps: n= 896
Patient 1
Predicted % Survival
100
90
80
Patient 2
70
60
Patient 3
50
40
30
20
Predicted Survival
Months Patient 1 Patient 2 Patient 3
12
95%
86%
62%
24
10
0
0
3
92%
6
82%
9
12
57%
15
18
Months after Device Implant
21
24
Implants: June 2006 – September 2009: Survival after LVAD Implant
Adult Primary LVAD Pumps: n= 1366
Pre-Implant
Patient 1
Patient 2
Patient 3
Gender
Age (yrs)
Male
50
Male
55
Male
60
History of CABG
History of Valve surgery
History of Dialysis
INR
No
No
No
1.0
No
No
No
1.5
No
No
No
2.0
Device Strategy
Pt Profile: Cardiogenic Shock
BTT
No
BTT
No
BTT
Yes
RA Pressure
RVEF (Severe)
Ascites
12
No
No
18
No
Yes
22
No
Yes
Predicted 2 year survival
Pulsatile/Intracorporeal
Continuous/Intracorporeal
84%
92%
74%
82%
50%
57%
INTERMACS: June 2006 – September 2009: Device Strategy Analysis
Adult Primary LVAD: BTT Listed, n=651
1.0
Proportion of Patients
0.9
0.8
Alive
(device in place)
58%
0.7
0.6
0.5
0.4
Transplant
31%
0.3
Death
(before transplant)
10%
Explanted (recovery) 1%
0.2
0.1
0.0
0
61%
3
6
9
12
15
18
Months after Device Implant
LVAD, left ventricular assist device; BTT, bridge-to-transplant
21%
17%
1%
21
24
INTERMACS 2012
 Research Database
 Regulatory Database (?)
 Quality Assurance Database (?)
 Electronic Health Record (?)
INTERMACS 2012
 Research Database
 Regulatory Database (?)
 Quality Assurance Database (?)
 Electronic Health Record (?)