Key result
Transaxillary TAVI with the Lotus valve was feasible and safe in patients unsuitable for transfemoral access, achieving 100% device success and zero 30-day mortality in a 10-patient cohort.
Why the study?
Is transaxillary TAVI with the Lotus valve feasible and safe in patients with severe aortic stenosis who are unsuitable for transfemoral access?
Observational (n=408)
Is transaxillary TAVI with the Lotus valve feasible and safe in patients with severe aortic stenosis who are unsuitable for transfemoral access?
Transaxillary TAVI using the Lotus valve appears to be a feasible and safe alternative access route for patients with severe aortic stenosis who are unsuitable for transfemoral access.
Answers are grounded in this paper and cite their sources.
Supports transaxillary Lotus TAVI feasibility in small TF-unsuitable cohort; leaves open confirmation in larger prospective studies.
OBJECTIVES: To assess the feasibility of axillary transcatheter aortic valve implantation (TAVI) using the Lotus valve. BACKGROUND: TAVI is used to treat patients with severe aortic stenosis, with transfemoral (TF) access being the safest and most widely used route. In patients unsuitable for this, there are reports that the axillary artery may be safest alternative access route. The Lotus device is a fully retrievable 2nd generation transcatheter heart valve which is licensed for femoral and transaortic access. There are limited data on the suitability of this valve for axillary access. METHODS: We assessed the feasibility of transaxillary TAVI with the Lotus valve in patients unsuitable for TF TAVI. Between January and October 2016, we identified 10 patients who underwent transaxillary TAVI with the Lotus valve. This cohort was compared with 347 (85%) patients who underwent TF TAVI, 45 (11%) patients who underwent and trans-apical or direct-aortic TAVI and the total group of 16 (4%) patients who underwent axillary TAVI. RESULTS: Ten patients aged 75 years (69-83) underwent attempted TAVI with the Lotus via axillary access. Device success was 100%. In-hospital and 30-day mortality was zero. There were no neurological events, no major vascular complications and no myocardial infarctions. Four of 10 patients required a pacemaker post-TAVI. No patient was left with moderate or greater aortic regurgitation. Median length of stay was 3 days CONCLUSIONS: TAVI with the Lotus valve is feasible via the axillary artery and appears safe in our small cohort of patients.
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Doshi et al. (2017) conducted an observational in severe aortic stenosis (n=408). Transaxillary TAVI with the Lotus valve vs. Transfemoral, trans-apical, direct-aortic, or other axillary TAVI was evaluated on Device success. Transaxillary TAVI with the Lotus valve was feasible and safe in patients unsuitable for transfemoral access, achieving 100% device success and zero 30-day mortality in a 10-patient cohort.
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