Objective To compare the incidence of silent cerebral infarction and impact on cognitive function following transcatheter aortic valve implantation (TAVI) with the first-generation CoreValve (Medtronic, Minneapolis, Minnesota, USA) and second-generation Lotus valve (Boston Scientific, Natick Massachusetts, USA).
Design A prospective observational study comprising a 1.5 T cerebral MRI scan, performed preoperatively and immediately following TAVI, and neurocognitive assessments performed at baseline, 30 days and 1 year follow-up.
Setting University hospitals of Leeds and Leicester, UK.
Patients 66 (80.6±8.0 years, 47% male) patients with high-risk severe symptomatic aortic stenosis recruited between April 2012 and May 2015.
Main outcome measures Incidence of new cerebral microinfarction and objective decline in neurocognitive performance.
Results All underwent cerebral MRI at baseline and immediately following TAVI, and 49 (25 Lotus, 24 CoreValve) completed neurocognitive assessments at baseline, 30 days and 1 year. There was a significantly greater incidence of new cerebral microinfarction observed following the Lotus TAVI (23 (79%) vs 22 (59%), p=0.025) with a greater number of new infarcts per patient (median 3.5 (IQR 7.0) vs 2.0 (IQR 3.0), p=0.002). The mean volume of infarcted cerebral tissue per patient was equivalent following the two prostheses (p=0.166). More patients suffered new anterior (14 (48%) vs 2 (5%), p=0.001) and vertebrobasilar (15 (52%) vs 7 (19%), p=0.005) lesions following Lotus. Lotus was associated with a decline in verbal memory and psychomotor speed at 30 days. However, performance longitudinally at 1 year was preserved in all neurocognitive domains.
Conclusions There was a higher incidence of silent cerebral microinfarction and a greater number of lesions per patient following Lotus compared with CoreValve. However, there was no objective decline in neurocognitive function discernible at 1 year following TAVI with either prosthesis.
- transcatheter aortic valve implantation
- cerebral MRI
- neurocognitive function
- boston lotus
- medtronic corevalve
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Patient consent for publication Not required.
Contributors JPG conceived and designed the study. TAM drafted the manuscript. CL compiled the comprehensive battery of neurocognitive tests and instructed on their correct implementation. FR, TAM, AU, LED and AS performed the recruitment of patients and their neurocognitive assessment. GPM supervised and AS oversaw the University of Leicester contribution. MI and AJPG performed MRI image analysis. DJB and CM carried out TAVI implantation. TAM and AU analysed data and interpreted the results. PPS and PG gave input into data interpretation. PPS, PG, JRJF, GJF, SP and GPM were involved in critical and intellectual revision of the article. All authors edited and revised the manuscript. All authors read and approved the final manuscript.
Funding This study was part-funded by the British Heart Foundation (PG/11/126/29321), an investigator research grant from Boston Scientific and also the National Institute for Health Research (NIHR) Leeds Clinical Research Facility.
Competing interests DJB and CM are consultants and proctors for both Medtronic and Boston Scientific. JPG and SP have received an educational research grant from Philips Healthcare.
Ethics approval National Research Ethics Service (08/H1307/106).
Provenance and peer review Not commissioned; externally peer reviewed.
Data sharing statement All clinically important data from this observational study have been reported on in the manuscript.
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