Disclosures. Consultant Thoratec, HeartWare Research Support Thoratec (2012) No off label...

Disclosures.Consultant Thoratec , HeartWareResearch Support Thoratec (2012)No off label use/indications will be discussed.

Asking a Question?

Question (Respondent)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)

ResponseTread 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 AspectsMechanical Valve Carries Perceived Risk Of StrokeAortic Insufficiency Impaisr MCS By Short CircuitAortic Insufficiency Will Worsen With Time

How durable are any of the options?

ConsiderationsThe addition of ischemic time ( cross clamp) to sick hearts (RV)Cross clamp time varies by techniqueDon’t Valves and repairs just fuse eventually anyway?

DAAP Suggestions1) 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,

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.

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.

2) What are the outcomes of patients that undergo an AV procedure with respect to the type of 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 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 DataProspective dataData CaptureLONGITUDINAL DATA- ALIVE/DEAD/ECHO DATANice People.

Adults: n=7808

All Primary Pts implantedAs of 12/31/2012

N=7887

Pediatric Patients: n=79(patients < 19 yrs of age

at time of implant)

Pulsatile Flow: *N=1087 Continuous Flow:

n=6721

Bi VAD: 179 LVAD: 6542 BiVAD: 301 TAH: 158 LVAD: 628

* The left ventricular device indicates the type of pump implanted (continuous flow or pulsatile flow).

Patient Pool

INTERMACS: June 2006 – December 2012: Aortic Insufficiency

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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 sutures3 pledgeted sutures4 pledgeted matress sutures

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 patchAortic VALVE OVERSEWN-pericardial patchAV oversewn closed w/ pledgetted suture and proleneAV oversewn closed w/ pledgetted suture and proleneN/AN/AN/AOversewing of aortic valvePre-exisiting MECHANICAL AV SURGERY--Aortic VALVE OVERSEWN-percardial patchReplacement of aortic valve with Hemashield patch

These were the good ones!


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 = 326Total Hospitals = 88

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Groups n LVAD BiVAD1)Aortic Closure 81 76 32)Aortic Repair 213 209 43)Aortic Replacement – Bio/Mech 95 92 34)All Others 6332 6165 169 Total 6721 6542 179

Group distribution AFTER finalization of additional data collection

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Final Groups n LVAD BiVAD1)Aortic Closure 136 131 52)Aortic Repair 165 163 23)Aortic Replacement – Bio/Mech 103 100 34)All Others 6317 6148 169 Total 6721 6542 179

Original Groups prior to additional data collection


Aortic Regurg – Pre-implant

Groups n None Mild Mod Sev Unknown1)Aortic Closure 136 19 (14.0%) 58 (42.6%) 34 (25.0%) 8 (5.9%) 17 (12.5%) 2)Aortic Repair 165 20 (12.1%) 69 (41.8%) 47 (28.5%) 1 (0.7%) 28 (16.9%) 3)Aortic Replacement (Bio/Mech) 103 12 (11.7%) 33 (32.0%) 28 (27.2%) 7 (6.8%) 23 (22.3%) 4)All Others 6317 3584 (56.7%) 1348 (21.3%) 83 (1.3%) 14 (0.2%) 1288 (20.4%) Total 6721 3635 (54.1%) 1508 (22.4%) 192 (2.9%) 30 (0.4%) 1356 (20.2%)

Group Summary AFTER finalization of additional data collection

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Aortic Regurg – Pre-implant

Groups n None Mild Mod Sev 1)Aortic Closure 119 19 (16.0%) 58 (48.7%) 34 (28.6%) 8 (6.7%) 2)Aortic Repair 137 20 (14.6%) 69 (50.4%) 47 (34.3%) 1 (0.7%) 3)Aortic Replacement (Bio/Mech) 80 12 (15.0%) 33 (41.3%) 28 (35.0%) 7 (8.7%) 4)All Others 5029 3584 (71.3%) 1348 (26.8%) 83 (1.6%) 14 (0.3%) Total 5365 3635 (67.8%) 1508 (28.1%) 192 (3.5%) 30 (0.6%)

Concomitant Aortic Valve Procedures in Patients Undergoing Implantation of

Continuous-Flow LVADs: An INTERMACS Database Analysis

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.

April 11, 2014

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: 581-589Pal JD, et al. Circulation. 2009; 120: S215-219Adamson RM, et al. JHLT. 2011; 30: 576-582Goda A, et al. Ann Thorac Surg. 2011; 91: 750-754Morgan 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=59Responded: 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=62Responded: patients=143(67%) hospitals=40 (65%)Unconfirmed: patients=70 (33%) hospitals=19 (31%)

Total Patients queried = 326 Total Hospitals queried = 88Total Patients with response = 229 (70%) Total Hospitals responded = 63 (72%)

Adults: Adults: N=7,808 N=7,808

All patients implantedAll patients implantedas of 12/31/2012as of 12/31/2012

N=7,887N=7,887

Pediatric Patients: Pediatric Patients: N=79N=79(patients < 19 yrs of age (patients < 19 yrs of age

at time of implant)at time of implant)

Pulsatile Flow: Pulsatile Flow: N=1,087N=1,087 Continuous Flow: Continuous Flow:

N=6,721 N=6,721

Bi VAD: N=179 Bi VAD: N=179 LVAD: N=6,542 LVAD: N=6,542 BiVAD BiVAD N=301N=301

TAH TAH N=158 N=158

LVAD LVAD N=628 N=628

INTERMACS Patient Population: June 2006 – December 2012

Bi VAD: N=140 Bi VAD: N=140 LVAD: N=5,204LVAD: N=5,204

Total Cohort: N=5,344Total Cohort: N=5,344

Database AuditReduced Cohort:

Mean Follow-up = 12.3 months

Aortic Valve ClosureAortic Valve Closure• Total=125Total=125• LVAD=121LVAD=121• BiVAD=4BiVAD=4

Aortic Valve RepairAortic Valve Repair• Total=95Total=95• LVAD=93LVAD=93• BiVAD=2BiVAD=2

Aortic Valve Aortic Valve ReplacementReplacement• Total=85Total=85• LVAD=83LVAD=83• BiVAD=2BiVAD=2

All OthersAll Others• Total=5,039Total=5,039• LVAD=4,907LVAD=4,907• BiVAD=132BiVAD=132

INTERMACS Patient Population: June 2006 – December 2012

Event = Death with a device in place (censored at transplant or recovery)

Months Post Implant

% S

urv

ival AV Repair

n=95, deaths=22

AV Closure, n=125, deaths=46

AV Replacementn=85, deaths=24

Overall p = 0.0003

No AV Proceduren=5039, deaths=1078

Survival by Type of Aortic Valve Procedure Performed

Months Post Implant

% S

urv

ival

% Survival post implantGroups n events 6 months 1 year

AV Closure 65 25 67% 56%AV Repair 56 16 85% 76%AV Replacement 37 11 76% 67%No AVP 2780 652 85% 79%

Survival for INTERMACS Level 1-2 Patients by Type of AVP

Overall p=0.003

Months Post Implant

% S

urv

ival

Overall p = 0.04

% Survival post implantGroups n events 6 months 1 year

AV Closure 60 21 85% 73%AV Repair 39 6 86% 82%AV Replacement 48 13 87% 75%No AVP 2258 426 89% 84%

Survival for INTERMACS Level 3-7 Patients by Type of AVP

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

Dialysis 1.85 1.32-2.58 0.0003

BiVAD 2.34 1.8-3.05 <0.0001


P-value


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

Dialysis 1.85 1.32-2.58 0.0003

BiVAD 2.34 1.8-3.05 <0.0001


P-value


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

1.85 1.32-2.58 0.0003

BiVAD 2.34 1.8-3.05 <0.0001

10%

6% 5%

5%8%

18% 19%

0% 0%

9%9%

3% 3%7%

10%12%

17%15%

0%

10%

20%

30%

40%

50%

60%

70%

80%

90%

100%

1 week 1 month 3 month 6 month 12 month 18 month 24 month

Aortic Closure Aortic Repair Aortic Replacement No AV Procedure

Aortic Closure, n=112Aortic Repair, n=85Aortic Replacement, n=67No AV Procedure, n=4,061

% o

f Pati

ents

with

Mod

erat

e/Se

vere

Aor

tic R

egur

gita

tion

Note: If the total n for the group is < 20 then it is not plotted in this figure.

p (6 months) < 0.0001

Recurrence of Aortic Insufficiency Postoperatively by Group

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.

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Thank You to INTERMACS

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Disclosures. Consultant Thoratec, HeartWare Research Support Thoratec (2012) No off label...

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Transcript of Disclosures. Consultant Thoratec, HeartWare Research Support Thoratec (2012) No off label...