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Presenter Disclosure Information. Robert E. Michler, M.D. Influence of Left Ventricular Volume Reduction on Outcome After Coronary Artery Bypass Grafting With or Without Surgical Ventricular Reconstruction Financial Disclosure: NIH STICH Grants NHLBI CT Surgery Network

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slide1

Presenter Disclosure Information

Robert E. Michler, M.D.

Influence of Left Ventricular VolumeReduction on Outcome After Coronary Artery Bypass Grafting With or Without Surgical Ventricular Reconstruction

Financial Disclosure: NIH STICH Grants

NHLBI CT Surgery Network

Unlabeled/Unapproved Uses Disclosure: No

slide2

Influence of Left Ventricular Volume Reduction on Outcome After Coronary Artery Bypass Grafting With or Without Surgical Ventricular Reconstruction

Robert E. Michler, Gerald M. Pohost, Krzysztof Wrobel, Robert O. Bonow, Jan Pirk, Jae K. Oh,

Carmelo A. Milano, Patricia A. Pellikka,

Francois Dagenais, Thomas A. Holly,

Anne S. Hellkamp, Kerry L. Lee, Marisa Di Donato,

on behalf of the STICH Investigators

Late-Breaking Clinical Trial Update

American College of Cardiology

March 16, 2010

slide3

Introduction

  • Ischemic cardiomyopathy resulting from progressive LV volume increase due to CAD and anterior-apical myocardial scar compromises clinical outcome.
  • The objective of surgical ventricular reconstruction (SVR) is to create a smaller left ventricle with a more natural shape.
  • One STICH (Surgical Treatment for Ischemic Heart Failure) Trial specific aim was to determine if adding SVR to CABG provided patient benefit beyond that of CABG alone.
svr hypothesis question
SVR Hypothesis Question

Does adding SVR to CABG in medically-treated ischemic heart failure patients decrease death/cardiac rehospitalization?

1000 patients randomized 2002-2006

CAD, EF ≤ 35%

Anterior akinesia/dyskinesia amenable to SVR

Randomized

499

CABG only

501

CABG + SVR

Follow-up 99% complete at 48-months

slide5

Purpose

  • To determine whether any magnitude of postoperative change in LV ESVI identified a subgroup of CABG + SVR patients who have increased survival when compared to patients undergoing CABG alone.
analysis design
Analysis Design
  • Cohort identified with paired core laboratory studies of fair to excellent quality permitting accurate assessment of end-systolic volume index (ESVI).
  • Individual preoperative and postoperative ESVI illustrated for patient groups with:

1. ESVI <60 mL/m2

2. ESVI 60-90 mL/m2

3. ESVI >90 mL/m2

  • Kaplan-Meier curves and hazard ratios calculated on cohorts to examine for a differential effect of adding SVR to CABG.
paired left ventricular studies before and after operation in 979 svr hypothesis patients
Paired Left Ventricular Studies Before and After Operation in 979 SVR Hypothesis Patients

86 (9%) of operated patients

16 NO baseline study

sent to core lab

107 NO 4-month study

sent to core lab

175 patients without

both paired studies of

fair to excellent quality

Observational cohort defined by ESVI taken from a Randomized population

slide9
Preoperative to Postoperative Change in ESVI by Operation Received160 Patients with Baseline ESVI < 60 mL/m2GROUP 1
slide10
Preoperative to Postoperative Change in ESVI by Operation Received200 Patients with Baseline ESVI 60–90 mL/m2GROUP 2
slide11
Preoperative to Postoperative Change in ESVI by Operation Received235 Patients with Baseline ESVI > 90 mL/m2GROUP 3
hazard ratios and 95 confidence intervals all cause mortality
Hazard Ratios and 95% Confidence IntervalsAll-Cause Mortality

All Patients (n=1000)

(as randomized)

All Patients (n=979)

(by operation received)

Patients with Pre & Post Surgery Studies

(n=595)

Patients Excluded (n=384)

CABG+SVR Better

CABG Only Better

hazard ratios and 95 confidence intervals all cause mortality14
Hazard Ratios and 95% Confidence IntervalsAll-Cause Mortality

Patients with Pre & Post Surgery Studies (n=595)

Baseline ESVI > 90 ml/m2 (n=235)

Baseline ESVI 60- 90 ml/m2 (n=200)

Baseline ESVI < 60 ml/m2 (n=160)

CABG+SVR Better

CABG Only Better

slide15
Kaplan-Meier Estimates: Cumulative Risk of DeathPatients with Pre & Post Surgery Studies : Baseline ESVI ≤ 90 mL/m2 (n=360)

HR=0.59 (95% CI: 0.35 – 1.00; rank test: p=0.0475)

Total events (63): 20 in CABG+SVR and 43 in CABG Only

slide16
Kaplan-Meier Estimates: Cumulative Risk of DeathPatients with Pre & Post Surgery Studies : Baseline ESVI > 90 mL/m2 (n=235)

HR=1.24 (95% CI: 0.75 – 2.06; rank test: p=0.4071)

Total events (60): 33 in CABG+SVRand 27 in CABG Only

hazard ratios and 95 confidence intervals all cause mortality17
Hazard Ratios and 95% Confidence IntervalsAll-Cause Mortality

Baseline ESVI ≤ 90 mL/m2 with Small or no Reduction (n=180)

Baseline ESVI ≤ 90 mL/m2 with Large Reduction

(n=180)

Baseline ESVI > 90 mL/m2 with Small or no Reduction

(n=117)

Baseline ESVI > 90 mL/m2 with Large Reduction

(n=118)

CABG Only Better

CABG+SVR Better

slide18

Kaplan-Meier Estimates: Cumulative Risk of DeathPatients with Pre & Post Surgery Studies Baseline ESVI > 90 mL/m2 and Small/or No Reduction in Post_Op ESVI (n=117)

HR=1.54 (95% CI: 0.80 – 2.98; rank test: p=0.1950)

Total events (36): 17 in CABG+SVR and 19 in CABG Only

Small/or no reduction = change from baseline ESVI ≤ -23.7 mL/m2

slide19

Kaplan-Meier Estimates: Cumulative Risk of DeathPatients with Pre & Post Surgery Studies Baseline ESVI > 90 mL/m2 and Large Reduction in Post_Op ESVI (n=118)

HR=1.20 (95% CI: 0.51 – 2.80; rank test: p=0.6777)

Total events (23): 16 in CABG+SVR and 8 in CABG Only

Large reduction = change from baseline ESVI > -23.7 mL/m2

limitations of study
Limitations of Study
  • Baseline LV volume and regional function data were not available in every STICH patient.
  • Secondary structural and hemodynamic variables related to LV function, such as sphericity index or mitral regurgitation, were not considered in this analysis.
  • Bias of investigators towards not sending suboptimal postoperative studies cannot be excluded.
slide21

Conclusions

  • A broad range of baseline ESVI is represented among STICH patients.
  • The postoperative ESVI decrease is significantly larger for CABG+SVR patients.
  • In patients with larger volumes, ESVI > 90 ml/m2, CABG alone resulted in a substantial reduction in ESVI.
  • Patients with preoperative ESVI values ≤ 90 ml/m2 trended toward benefit from CABG + SVR, whereas patients with preoperative ESVI values > 90 ml/m2 trended toward benefit from CABG alone.
  • No threshold of ESVI at baseline, ESVI at 4 months postoperative or ESVI volume change identified a patient group that benefited from adding SVR to CABG.
  • The post-op ESVI is the most important prognostic mortality measure. Its prognostic importance is significant even after accounting for the baseline ESVI or the pre-to-post change in ESVI.
change in regional cardiac function in 504 svr hypothesis pts

Dyskinesia

Normal

Change in Regional Cardiac Function in 504 SVR Hypothesis Pts

Group 1: LVESVI < 60 mL/m2 (N = 129)

Postoperative

Preoperative

CABG

N = 70

CABG + SVR

N = 59

change in regional cardiac function in 504 svr hypothesis pts24

Dyskinesia

Normal

Change in Regional Cardiac Function in 504 SVR Hypothesis Pts

Group 2: LVESVI 60–90 mL/m2 (N = 170)

Postoperative

Preoperative

CABG

N = 96

CABG + SVR

N = 74

change in regional cardiac function in 504 svr hypothesis pts25

Dyskinesia

Normal

Change in Regional Cardiac Function in 504 SVR Hypothesis Pts

Group 3: LVESVI > 90 mL/m2 (N = 205)

Postoperative

Preoperative

CABG

N = 105

CABG + SVR

N = 100

hazard ratios and 95 confidence intervals all cause mortality26
Hazard Ratios and 95% Confidence IntervalsAll-Cause Mortality

Patients with Pre & Post Surgery Studies

(n=595)

Post-Op ESVI > 90 mL/m2 (n=150)

Post-Op ESVI 60- 90 mL/m2 (n=198)

Post-Op ESVI < 60 mL/m2 (n=247)

CABG+SVR Better

CABG Only Better