Key result
Trans-subclavian and axillary SAPIEN 3 TAVR achieves ~97% access success with no difference by approach.
Why the study?
The study evaluated the efficacy and safety of trans-subclavian and axillary TAVR with a balloon-expandable valve, and assessed whether access types affected procedural and 30-day outcomes.
Is trans-subclavian and axillary transcatheter aortic valve replacement with the SAPIEN 3 valve safe and effective in patients with hostile femoral anatomy?
Observational (n=75)
Yes
Is trans-subclavian and axillary transcatheter aortic valve replacement with the SAPIEN 3 valve safe and effective in patients with hostile femoral anatomy?
Trans-subclavian and axillary TAVR with the SAPIEN 3 valve is a safe and effective alternative for patients with hostile femoral anatomy, with outcomes independent of the specific subclavian/axillary access technique used.
Supports trans-subclavian/axillary TAVR with SAPIEN 3 in hostile femoral anatomy; leaves open randomized confirmation of safety and technique equivalence.
Background The ACCESS Study is a prospective, multicenter registry to evaluate the efficacy and safety of trans-subclavian and axillary transcatheter aortic valve replacement (TAx-TAVR) with the latest-generation balloon-expandable transcatheter valve (THV). The secondary goal of this study was to determine whether the type of TAx access (left versus right, supraclavicular-subclavian versus infraclavicular-axillary, cutdown versus percutaneous) made a difference in procedural and 30-day outcomes.Methods 75 consecutive patients from March 2016 to June 2018 with hostile femoral anatomy and favorable subclavian or axillary anatomy underwent TAx-TAVR using the SAPIEN 3 THV (Edwards Lifesciences, Irvine, CA) at six experienced centers. Demographics, procedural characteristics, in-hospital, and 30-day outcomes were recorded.Results Successful TAx access was obtained in 73 (97.3%) patients. Left subclavian 32 (42.7%) and left axillary 26 (34.6%) were the most common access sites followed by right subclavian 9 (12.0%) and right axillary 6 (8.0%). Nineteen (25.3%) of the patients underwent TAx-TAVR using a complete percutaneous technique. Vascular access complications requiring intervention during hospitalization occurred in 5 (6.7%). The in-hospital total stroke rate was 5.3% with debilitating stroke occurring in 2.7% of patients and did not appear to differ based on the type of TAx access. Thirty-day mortality was 4.0%.Conclusions TAx-TAVR with the SAPIEN 3 THV is an effective and safe alternative showing high procedural success and low rates of vascular injury. The type of TAx access (left versus right, subclavian versus axillary, cutdown versus percutaneous) does not appear to make a significant difference in procedural and 30-day outcomes.Abbreviations TAVR: transcatheter aortic valve replacement; TAx: trans-subclavian-axillary; THV: transcatheter valve; TA: transapical; TC: transcarotid; TF: transfemoral; LIMA: left internal mammary artery; SEM: standard error of the mean; SD: standard deviation; STS: Society of Thoracic Surgeons; BMI: body mass index; CABG: Coronary artery bypass graft; ICU: Intensive care unit; LOS: length of stay; MI: myocardial infarction; PCI: percutaneous coronary intervention; ESRD: end-stage renal disease; TAo: trans-aortic; TIA: transient ischemic attack.
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Dahle et al. (2020) conducted an observational in Hostile femoral anatomy requiring TAVR (n=75). Trans-subclavian and axillary transcatheter aortic valve replacement (TAx-TAVR) with SAPIEN 3 THV vs. Different types of TAx access (left vs right, subclavian vs axillary, cutdown vs percutaneous) was evaluated on Successful TAx access. Trans-subclavian and axillary TAVR with the SAPIEN 3 THV achieved 97.3% successful access, 5.3% in-hospital stroke, and 4.0% 30-day mortality, with no significant differences by access type.
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