Aortic Insufficiency – Framing the Issue Through INTERMACS
Scott Silvestry, MD
Disclosures.
Consultant Thoratec , HeartWare
Research Support Thoratec (2012)
No off label use/indications will be discussed.
Asking a Question?
Question (Respondent)
Response
What movie would you like to
see?( Spouse)
Is it cancer?(Radiologist)
Would you agree that the
standard was not met? (Lawyer)
What is the best
treatment?(Clinician)
What should a surgeon do with AI
at the time of a
VAD?(INTERMACS)
Tread lightly- consider previous choices
and whose choice was last made.
Cannot rule out….
Please restate.
It depends.
Let’s look at the data.
Aortic Insufficiency
Clinician Aspects
Mechanical Valve Carries
Perceived Risk Of Stroke
Aortic Insufficiency Impaisr
MCS By Short Circuit
Aortic Insufficiency Will
Worsen With Time
How durable are any of the
options?
Considerations
The addition of ischemic time (
cross clamp) to sick hearts (RV)
Cross clamp time varies by
technique
Don’t Valves and repairs just
fuse eventually anyway?
DAAP Suggestions
1) What are the outcomes of patients with important AI
who do not undergo an AV procedure compared to
those that do have an AV procedure performed; and,
2) What are the outcomes of patients that undergo an
AV procedure with respect to the type of procedure
performed?
Compare important outcomes of patients
stratified to the following groups by pre-implant
assessment of the degree of AI and subsequent
intervention:
Group 1: AI – None; Group 2: AI – Mild with NO
AV procedure performed; Group 3: AI – Mild with
AV procedure performed; Group 4: AI – Moderate
or more with NO AV procedure performed; and
Group 5: AI – Moderate or more with AV
procedure performed.
For those patients that did receive an AV
procedure, the patients should be stratified
by type of procedure;
Group I – AV replacement; Group II – AV
repair; Group III – Other AV procedure.
The outcome measures that the DAAP Committee
would recommend/suggest to assess would be: 1)
survival; 2) duration of inotrope support; 3)
freedom from RV failure; 4) renal function (both
early and late); 5) duration of ICU stay; 6) total
LOS for index hospitalization; 7) freedom from
readmission; and 8) freedom from AI – Moderate
or more.
The outcome measures that the DAAP
Committee would recommend/suggest to
follow would be 1: Survival; 2) Freedom
from stroke; 3) Freedom from AI –
Moderate or More; and 4) Freedom from
RV failure. These outcomes measures
would importantly assess the stroke risk
from each of the procedures and durability
of preventing recurrence of AI.
Why INTERMACS?
Size of Data
Prospective data
Data Capture
LONGITUDINAL DATA- ALIVE/DEAD/ECHO DATA
Nice People.
INTERMACS: June 2006 – December 2012: Aortic Insufficiency
All Primary Pts implanted
As of 12/31/2012
N=7887
Pediatric Patients: n=79
(patients < 19 yrs of age
at time of implant)
Adults:
n=7808
Pulsatile Flow: *
N=1087
BiVAD: 301
TAH: 158
Patient Pool
Continuous Flow:
n=6721
LVAD: 628
Bi VAD: 179
LVAD: 6542
7
* The left ventricular device indicates the type of pump implanted (continuous flow or pulsatile flow).
A visit to INTERMACS
Problems?
• Data not complete
• Apparent Inconsistencies in responses
– Severe AI with no procedure????
– Replacement with mechanical valve
• Previous version did not capture the same
fields/data
• Massive Variation in Clinical practice and
terminology.
"The aorta was clamped and infused with cold blood cardioplegia antegrade for a total of 1L. A Transverse aortotomy
was made. Mildly to moderately thickened aortic valve lesions were noted. Using three stripes of Teflon and running
4-0 Prolene suture, the aortic valve was closed shut to deal with the aortic insufficiency. The aortomoy was then
closed with 4-0 Prolene suture in two layers."
"The previously placed Bjork-Shiley valve was visualized. A sandwich felt technique was used to patch the valve from
the ventricular and the aortic aspect in order to prevent any exposure of the valave to circulation to reduced the
development of thrombosis and passive mobilization. This was done with 2 circular patches sutured together through
the aortic valve prosthesis. An additional portion of felt patch had to be used to completely cover the aotic valve on
the aortic aspect. The patch was then sewn to the side of the graft to fully exclude the valve. The aortotomy was then
closed with 2 running layers of 4-0 Prolene."
3 pledgeted sutures
3 pledgeted sutures
4 pledgeted matress sutures
These were the good ones!
4-0 prolene pursestring suture on each leaflet; additional pledgeted 4-0 prolene between rt & lt commissures.
A piece of bovine pericardial patch was fashioned to the size of the aortic valve. It was sewn into place to cover the
aortic valve using a series of 4 pledgeted 4-0 Prolene sutures.
All had notes that stated AV was repaired, but in details in the notes all were found to have been oversewn with
leaflets closed.
Aortic VALVE OVERSEWN-pericardial patch
Aortic VALVE OVERSEWN-pericardial patch
AV oversewn closed w/ pledgetted suture and prolene
AV oversewn closed w/ pledgetted suture and prolene
N/A
N/A
N/A
Oversewing of aortic valve
Pre-exisiting MECHANICAL AV SURGERY--Aortic VALVE OVERSEWN-percardial patch
Replacement of aortic valve with Hemashield patch
INTERMACS: June 2006 – December 2012: Aortic Insufficiency
Additional Data Collection Summary
Question 1:
Patients with Moderate/Severe Aortic Insufficiency
at time of implant but no concomitant AV surgery recorded:
patients=131, hospitals=59
Question 2:
Patients with Documented Concomitant Aortic Repair at time of
implant – verification of AV closure and/or AV repair:
patients=213, hospitals=62
Total Patients = 326
Total Hospitals = 88
11
INTERMACS: June 2006 – December 2012: Aortic Insufficiency
Original Groups prior to additional data collection
Groups
1)Aortic Closure
2)Aortic Repair
3)Aortic Replacement – Bio/Mech
4)All Others
Total
n
81
213
95
6332
6721
LVAD
76
209
92
6165
6542
BiVAD
3
4
3
169
179
Group distribution AFTER finalization of additional data collection
Final Groups
1)Aortic Closure
2)Aortic Repair
3)Aortic Replacement – Bio/Mech
4)All Others
Total
n
136
165
103
6317
6721
LVAD
131
163
100
6148
6542
BiVAD
5
2
3
169
179
13
INTERMACS: June 2006 – December 2012: Aortic Insufficiency
Group Summary AFTER finalization of additional data collection
Aortic Regurg – Pre-implant
Groups
n None
Mild
1)Aortic Closure
136
19 (14.0%)
58 (42.6%)
2)Aortic Repair
165
20 (12.1%)
69 (41.8%)
3)Aortic Replacement (Bio/Mech) 103
12 (11.7%)
33 (32.0%)
4)All Others
6317 3584 (56.7%) 1348 (21.3%) 83 (1.3%)
Total
6721 3635 (54.1%) 1508 (22.4%)
Mod
34 (25.0%)
47 (28.5%)
28 (27.2%)
14 (0.2%)
192 (2.9%)
Sev
Unknown
8 (5.9%)
17 (12.5%)
1 (0.7%)
28 (16.9%)
7 (6.8%)
23 (22.3%)
1288 (20.4%)
30 (0.4%)
1356 (20.2%)
Aortic Regurg – Pre-implant
Groups
n None
Mild
1)Aortic Closure
119
19 (16.0%)
58 (48.7%)
2)Aortic Repair
137
20 (14.6%)
69 (50.4%)
3)Aortic Replacement (Bio/Mech) 80
12 (15.0%)
33 (41.3%)
4)All Others
5029 3584 (71.3%) 1348 (26.8%) 83 (1.6%)
Total
5365 3635 (67.8%) 1508 (28.1%)
Mod
34 (28.6%)
47 (34.3%)
28 (35.0%)
14 (0.3%)
192 (3.5%)
Sev
8 (6.7%)
1 (0.7%)
7 (8.7%)
30 (0.6%)
14
16
Concomitant Aortic Valve Procedures in
Patients Undergoing Implantation of
Continuous-Flow LVADs: An INTERMACS
Database Analysis
April 11, 2014
Jason Robertson, M.D., M.S.; David C. Naftel, Ph.D., Sunil Prasad, M.D.;
Akinobu Itoh, M.D.; Susan Myers; Gail Mertz, B.S., R.N., CCRC; James
Kirklin, M.D.; and Scott Silvestry, M.D.
Disclosures: Robertson – none; Naftel – none; Prasad - none; Itoh – none; Myers – none; Mertz – none; Kirklin – none;
Silvestry – Consultant for Thoratec and HeartWare
This project has been funded in whole or in part with federal funds from the National Heart, Lung and Blood Institute,
National Institutes of Health, Department of Health and Human Services, under Contract No. HHSN268201100025C
Outcomes Following Aortic Valve Procedures
• Previous studies have disagreed on whether mortality after
concomitant aortic valve procedures is increased, with some studies
demonstrating equivalent or improved survival.
• The largest of these used data from the HeartMate II BTT and DT
Trials (n=1,106), including:
• 30 AVRs
• 32 AV closures
• 18 AV repairs
• Long term survival was significantly reduced compared to HMII implant
alone:
• 1-year Survival: 57% vs. 75%, p=0.001
• 2-year Survival: 43% vs. 64%, p=0.001
Dranishnikov N, et al. Int J Artif Organs. 2012; 35 (7): 489-94.
John R, et al. JTCVS. 2014; 147: 581-589
Pal JD, et al. Circulation. 2009; 120: S215-219
Adamson RM, et al. JHLT. 2011; 30: 576-582
Goda A, et al. Ann Thorac Surg. 2011; 91: 750-754
Morgan JA, et al. JHLT. 2013; 32: 1255-1261
INTERMACS Database Additional Data Collection Summary
Question 1:
Audit of patients with documented moderate/severe AI without a
documented AVP to determine if an AVP was in fact performed:
Queried:
patients=113
hospitals=59
Responded:
patients=86 (76%)
hospitals=47 (80%)
Question 2:
Clarification of whether patients with documented AV repairs
underwent a closure or a repair:
Queried:
patients=213
hospitals=62
Responded: patients=143(67%) hospitals=40 (65%)
Unconfirmed:
patients=70 (33%)
hospitals=19 (31%)
Total Patients queried
= 326
Total Hospitals queried
= 88
Total Patients with response = 229 (70%)
Total Hospitals responded = 63 (72%)
INTERMACS Patient Population: June 2006 – December 2012
All patients implanted
as of 12/31/2012
N=7,887
Pediatric Patients: N=79
(patients < 19 yrs of age
at time of implant)
Adults:
N=7,808
Pulsatile Flow:
N=1,087
BiVAD
N=301
TAH
N=158
Continuous Flow:
N=6,721
LVAD
N=628
Reduced Cohort:
Mean Follow-up = 12.3
months
Bi VAD: N=179
LVAD: N=6,542
Database
Audit
Bi VAD: N=140
LVAD: N=5,204
Total Cohort: N=5,344
INTERMACS Patient Population: June 2006 – December 2012
Aortic Valve Closure
Aortic Valve Repair
• Total=125
• LVAD=121
• BiVAD=4
• Total=95
• LVAD=93
• BiVAD=2
Aortic Valve
Replacement
All Others
• Total=85
• LVAD=83
• BiVAD=2
• Total=5,039
• LVAD=4,907
• BiVAD=132
Survival by Type of Aortic Valve Procedure Performed
% Survival
No AV Procedure
n=5039, deaths=1078
AV Replacement
n=85, deaths=24
AV Repair
n=95, deaths=22
AV Closure,
n=125, deaths=46
Overall p = 0.0003
Months Post Implant
Event = Death with a device in place (censored at transplant or recovery)
Survival for INTERMACS Level 1-2 Patients by Type of AVP
1 year
56%
76%
67%
79%
% Survival
Groups
AV Closure
AV Repair
AV Replacement
No AVP
% Survival post implant
n events
6 months
65
25
67%
56
16
85%
37
11
76%
2780
652
85%
Overall p=0.003
Months Post Implant
Survival for INTERMACS Level 3-7 Patients by Type of AVP
% Survival
Groups
AV Closure
AV Repair
AV Replacement
No AVP
% Survival post implant
n events
6 months
60
21
85%
39
6
86%
48
13
87%
2258 426
89%
Overall p = 0.04
Months Post Implant
1 year
73%
82%
75%
84%
Multivariate Model for Death After Implant
Risk Factor
Hazard Ratio Confidence
Interval
P-value
Aortic
Regurgitation
0.98
0.87-1.10
0.75
AV Repair
0.83
0.54-1.27
0.39
AVR
1.36
0.84-2.19
0.21
Closure
1.87
1.39-2.53
<0.0001
INTERMACS
Level 1
1.23
1.01-1.51
0.04
Preop
Dialysis
Dialysis
BiVAD
BiVAD
1.85
1.32-2.58
0.0003
2.34
2.34
1.8-3.05
1.8-3.05
<0.0001
<0.0001
% of Patients with Moderate/Severe Aortic Regurgitation
Recurrence of Aortic Insufficiency Postoperatively by Group
100%
Aortic Closure, n=112
Aortic Repair, n=85
Aortic Replacement, n=67
No AV Procedure, n=4,061
90%
80%
70%
60%
50%
p (6 months) < 0.0001
40%
30%
18%
20%
10%
0%
8%
5%
1 week
17%
15%
12%
10%
3%
0%
19%
9%
10%
9%
3%
0%
1 month
Aortic Closure
7%
6%
3 month
Aortic Repair
5%
6 month
12 month
Aortic Replacement
Note: If the total n for the group is < 20 then it is not plotted in this figure.
18 month
24 month
No AV Procedure
27
Question Answered?
• Elements of Spouse, Radiologist, Lawyer,
clinician answers rolled up into one.
• Our study highlights some of the strengths
and weakness of the data in INTERMACS
• Clinical Question answered but questions
remain.
– Role of CPB/Cross Clamp
– Clinician Bias?
– Non Responsive centers- some want in.
28
Thank You to INTERMACS
29