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Jun 02, 2023 157 likes •347 views

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,

SLIDE 1

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, Allan D. Waggoner, MHS for The SMART-AV Trial Investigators.

SLIDE 2

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

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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
f 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

ASE proposed mitral inflow method for routine AV optimization after

CRT

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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.

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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

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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)

Echo (Iterative) SmartDelay Fixed (120/0) 3- month Visit 6- month Visit 3- month Visit 6- month Visit 6- month Visit 3- month Visit

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

SLIDE 7

Baseline Patient Characteristics

Characteristics

SD (n=332) Echo (n=323) Fixed (n=326) p-value Age (yrs) 66 ± 11 66 ± 11 66 ± 11 ns Gender (% male) 71% 68% 65% ns Resting heart rate (bpm) 71 ± 12 72 ± 13 71 ± 13 ns Ejection fraction (%) 25 ± 7 24 ± 7 25 ± 7 ns QRS duration (ms) 152 ± 21 153 ± 20 153 ± 20 ns History of ventricular fibrillation 2% 1% 2% ns History of paroxysmal atrial fibrillation 11% 11% 14% ns LBBB/RBBB/IVCD (%) 79/11/9 72/16/10 79/11/9 ns Ischemic cardiomyopathy 57% 57% 56% ns NYHA FC II/III/IV heart failure 4/92/4% 2/96/2% 2/95/3% ns

Continuous variables are expressed as mean ± SD

SLIDE 8

SMART-AV – Patient Flow

Implanted n=1014 Randomized n=980 Fixed (120/0) n=325 SmartDelay n=332 Withdrawn, LTFU

r Missing data

n=49 Evaluable Data n=283 (85%) Echo (Iterative) n=323 Withdrawn, LTFU

r Missing data

n=41 Evaluable Data n=282 (87%) Withdrawn, LTFU

r Missing data

n=44 Evaluable Data n=281 (86%) Enrolled n=1060

SLIDE 9

Primary Endpoint – LVESV

SLIDE 10

Secondary Structural Endpoints – LVEDV, LVEF

SLIDE 11

Secondary Functional Endpoints – Six Min Walk, QOL

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Secondary Endpoint – NYHA Class

SLIDE 13

Distribution of AV Delays at 6-months post-implant

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Primary Endpoint Subgroup: Etiology, Atrial Pacing %

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Primary Endpoint Subgroup: Bundle Branch Block, QRS Width

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Primary Endpoint Subgroup: Gender

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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