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SMART AV: No significant advantage in LVESV reported for SmartDelay device
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American Heart Association Scientific Sessions 2010
CHICAGO — Data from the SMART AV DELAY trial has shown no significant benefit in left ventricular end-systolic volume for SmartDelay AV Optimization treatment when compared to echocardiography and standard therapy.
The randomized trial compared empiric (fixed; n=281), echocardiographic guided (n=264) and algorithmic AV delay programming (SmartDelay, Boston Scientific; n=283) in cardiac resynchronization therapy (CRT) in 1,014 patients with HF from 100 sites in the US and Europe. All patients had suboptimal atrioventricular interval delay and the mean age 66 ± 11 years with a mean left ventricular ejection fraction of 25% ± 7%. The primary endpoint was defined as left ventricular end-systolic volume (LVESV) and the secondary endpoints were six-minute walk test, ejection fraction, NYHA class, left ventricular end-diastolic volume and quality of life.
According to trial results, improvements in changes of LVESV for SmartDelay and echocardiography (P=.52) as well as between SmartDelay and fixed groups (P=.66) did not reach clinical significance. There were also no reported significant differences between the three study groups in any of the secondary endpoints.
“The bottom line is that routine optimization of the AV interval by the American Society of Echocardiography guidelines has been shown not to be useful. It’s not cost-effective, it uses up resources and it should not be broadly applied to patients who get CRT devices,” Kenneth A. Ellenbogen, MD, vice chairman of cardiology at VCU Pauley Heart Center, Richmond, Virginia, and trial researcher told Cardiology Today. “On the other hand, patients who are nonresponders to CRT therapy may benefit from AV optimization either by pressing a button on the program with a smart AV delay algorithm or echo-guided AV delay optimization.”
Ellenbogen reports receiving research grants from Boston Scientific, as well as serving on the consultant/advisory board and giving lectures for Boston Scientific. – by Brian Ellis
For more information:
- Ellenbogen K. LBCT II, Abstract 21780. Presented at: American Heart Association Scientific Sessions 2010; Nov. 13-17; Chicago.
The first thing to keep in mind is that the patient population in SMART-AV was noticeably smaller than previous randomized controlled trials. We can concluded that AV delay optimization using an intracardiac electrogram-based algorithm or echocardiography does not improve volumetric and clinical outcome in CRT patients compared to fixed AV delay in the global CRT population, but might be helpful in some specific patients especially the nonresponders.
– Christophe Leclercq, MD, PhD
Department
of Cardiology, Centre Cardio-Pneumologique
Rennes, France
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