Real-world outcomes in cardiac resynchronization therapy patients: design and baseline demographics of the SMART- Registry
Roy S Gardner 1 , Antonio D'Onofrio 2 , George Mark 3 , Daniel Gras 4 , Yan Hu 5 , Sara Veraghtert 5 , Ignacio Garcia-Bolao 6 7
Aims: The SMART (Strategic MAnagement to optimize response to cardiac Resynchronization Therapy) Registry was designed to assess real-world outcomes for patients receiving a cardiac resynchronization therapy defibrillator (CRT-D) and to better understand which programming and optimization techniques are used and how effective they are.
Methods and results: The SMART Registry is a global, multicentre, prospective, observational, post-market CRT-D registry with a planned enrolment of 2000 subjects from a maximum of 200 sites in Europe, North America, and Asia-Pacific region. Each subject will be followed up for a minimum of 12 months.
The primary endpoint of CRT response rate at 12 months is defined by a clinical composite score of all-cause mortality, heart failure events, New York Heart Association Class, and quality of life as assessed by a patient global assessment instrument. A subgroup composed of the first 103 consecutive European subjects implanted with an NG4 device will have left ventricular multisite pacing feature enabled at any time during the initial 12 months of follow-up. The primary endpoint for this sub-analysis will be the NG4 PG-related complication-free rate at 36 months.
Conclusions: The SMART Registry achieved its recruitment target in August 2019, with 2014 patients enrolled. The baseline demographics demonstrated that patients were generally older, with greater co-morbidity, and on more contemporary medical therapy than in the key CRT trials. The results of the SMART Registry will determine which programming and optimization techniques are effective in this real-world population.
CITATION ESC Heart Fail. 2021 Apr;8(2):1675-1680. doi: 10.1002/ehf2.13192. Epub 2021 Jan 19.