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Primary Results from the SMART AV DELAY Trial: A Randomized Trial Comparing Empiric, Echocardiographic Guided and Algorithmic AV Delay Programming in Cardiac Resynchronization Therapy (CRT).

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Primary Results from the SMART AV DELAY Trial: A Randomized Trial Comparing Empiric, Echocardiographic Guided and Algorithmic AV Delay Programming in Cardiac Resynchronization Therapy (CRT)

Kenneth A. Ellenbogen, MD, Michael R. Gold, PhD, MD, Bernd Lemke, MD, Ignacio F. Lozano, MD, Timothy E. Meyer, PhD, Suneet Mittal, MD, Jagmeet P. Singh, MD, Frank G. Spinale, PhD, MD, Kenneth M. Stein, MD, Jennifer E. Van Eyk, PhD, Alan D. Waggoner, MHS for The SMART-AV Trial Investigators.

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Presenter Disclosure Information

Kenneth A. Ellenbogen, MD

Primary Results from the SMART AV DELAY Trial (Boston Scientific)

FINANCIAL DISCLOSURE:

Research Grants: Boston Scientific, Medtronic, St. Jude Medical, Biosense Webster, Sanofi

Consulting / Advisory board: Boston Scientific, Biotronik, Medtronic, St. Jude Medical, Sorin Group, Sanofi, Cardionet, Atricare, EBR

Lectures: Boston Scientific, Biotronik, Medtronic, St. Jude Medical, Sorin Group, Sanofi

Stock Options: None; Salary Support: None; Speaker Bureau: None

UNLABELED/UNAPPROVED USES DISCLOSURE: None

All devices used in the SMART-AV trial were Boston Scientific

smart av background
SMART-AV (Background)
  • In patients with heart failure and prolonged QRS duration, cardiac resynchronization therapy (CRT) reduces heart failure hospitalizations and prolongs survival compared with optimal medical therapy (OMT).
  • Achieving the optimal outcome from CRT may be dependent on proper programming of the optimal atrioventricular (AV) delay.
  • However, large scale randomized trials establishing the overall efficacy of CRT have differed widely in their approach to AV optimization.
    • CONTAK CD – No optimization
    • CARE-HF and MIRACLE – Doppler echocardiography of transmitral flow
    • COMPANION – algorithm based on the intrinsic AV interval and baseline QRS
  • The ASE proposed a mitral inflow method for routine AV optimization after CRT.
objectives
Objectives
  • To compare three alternative AV optimization techniques and to assess the hypotheses that:

1) systematic AV delay optimization using echocardiography and/or the SD algorithm is superior to a fixed nominal AV delay as demonstrated by improved LV geometry after 6 months and

2) that programming according to SD is non-inferior to using echocardiography-determined AV delay optimization.

methods
Methods

SMART-AV Inclusion

NYHA class III or IV

EF < 0.35

QRS >120ms

Expected to be in sinus rhythm at the time of implant

Willing and capable of undergoing a device implant and participating in all testing

Receiving OPT

SMART-AV Exclusion

Complete heart block or unable to tolerate pacing at VVI-40-RV for up to 14 days

Previously received CRT

  • Primary Endpoint:
  • LVESV at 6 months
  • Secondary Endpoints:
  • 6 min walk, EF, NYHA Class, LVEDV, QOL (MLWHF)
  • Statistics:
  • Continuous outcomes: general linear model - F test
  • Categorical outcomes: risk difference of proportions – Chi-squared test
  • Applicable to primary, secondary and subgroup analyses
smart av study design
SMART-AV – Study Design

Enrollment and Implant CRT-D with SmartDelay

Program device to VVI-40-RV

Post-Implant Visit (1 to 14 days post-implant)

(1:1:1 Randomization, Programmed to DDD(R)60)

SmartDelay

Echo (Iterative)

Fixed (120/0)

3- month Visit

3- month Visit

3- month Visit

6- month Visit

6- month Visit

6- month Visit

Stein KM, et al. Pacing Clin Electrophysiol. 2010;33(1):54-63

baseline patient characteristics
Baseline Patient Characteristics

Continuous variables are expressed as mean ± SD

smart av patient flow
SMART-AV – Patient Flow

Enrolled

n=1060

Implanted

n=1014

Randomized

n=980

SmartDelay

n=332

Echo (Iterative)

n=323

Fixed (120/0)

n=325

Withdrawn, LTFU or Missing data

n=49

Withdrawn, LTFU or Missing data

n=41

Withdrawn, LTFU or Missing data

n=44

Evaluable Data

n=283 (85%)

Evaluable Data

n=282 (87%)

Evaluable Data

n=281 (86%)

summary conclusion
Summary& Conclusion

The change in LVESV for the SD arm was no different than either the Echo or Fixed arms.

There were no significant differences in the secondary structural or functional endpoints by optimization group.

Patients with a wide QRS duration, LBBB, non-ischemic cardiomyopathy, and female gender responded more favorably to CRT therapy.

In post-hoc analysis, females optimized with SD and Echo responded more favorably than females randomized to the Fixed arm.

The routine use of AV optimization techniques as assessed in this trial is not warranted. However, this data does not exclude possible utility in selected patients who do not respond to CRT.