https://orcid.org/0000-0002-2882-2597
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ABSTRACT
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.
Acknowledgments
The authors would like to thank Jennifer Humbert, RN, Victoria Elliott, Patrick Ilboudo, Aderonke Gbadebo, Sandra Gilk, RN for all their assistance in the organization, data collection, and statistical analysis of this study. In addition, the authors would like to thank Edwards Lifesciences for the research grant support which made this author initiated study possible.
Disclosure statement
The following authors have performed speaker/consulting/education services for Edwards Lifesciences: Thom G. Dahle, MD, Brian M. Stegman, MD, Chad A. Kliger, MD, Tsuyoshi Kaneko, MD, Pinak B. Shah, MD, Mark D. Rothenberg, MD, and Sara J. Dezell, RN, CNS.