Subclavian and Axillary Alternative Access for Transcatheter Aortic Valve implantation with Sapien 3: Results from the Prospective Multicenter ACCESS Study

Dahle, Thom

Subclavian and Axillary Alternative Access for Transcatheter Aortic Valve implantation with Sapien 3: Results from the Prospective Multicenter ACCESS Study

Tuesday, May 21, 2019

Belmont Ballroom 2-3 (The Cosmopolitan of Las Vegas)

Thom Dahle, M.D., FSCAI , CentraCare Heart and Vascular Center, St. Cloud, MN

Brian Stegman, M.D. , CentraCare Heart and Vascular Center, St Cloud, MN

Michael Reed, MD , International Heart Institute, Missoula, MT

Stewart Long, III, MD , International Heart Institute, Missoula, MT

Chad Kliger, M.D., FSCAI , Lenox Hill Heart and Vascular Institute of New York, New York, NY

Derek Brinster, MD , International Heart Institute, Missoula, MT

Tsuyoshi Kaneko, MD , Brigham & Women's Hospital, Boston, MA

Pinak Bipin Shah, M.D., FSCAI , Brigham & Women's Hospital, Boston, MA

Marcos Nores, MD , JFK Medical Center, Atlantis, FL

Mark Rothenberg , University of Miami Palm Beach Regional Campus, Atlantis, FL

Atul Chawla, MD , Iowa Heat Center-W Des Moines, Des Moines, IA

David Mcallister, DO , Iowa Heat Center-W Des Moines, Des Moines, IA

Sara Dezell, RN, CNS , CentraCare Heart and Vascular Center, St Cloud, MN

Jennifer Humbert, RN , CentraCare Heart and Vascular Center, St Cloud, MN

Victoria Elliott , CentraCare Heart and Vascular Center, St Cloud, MN

Nathaniel Castro, MD , CentraCare Heart and Vascular Center, St Cloud, MN

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).

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. Valve-in-valve implantation was excluded. Demographics, procedural characteristics, in-hospital, and 30 day outcomes were recorded.

Results
Average patient age was 81.4 ±5.8 years (51.7% male) with STS score of 6.3 ±2.3%. Preoperative comorbidities included peripheral arterial disease (60%), diabetes (32%), chronic lung disease (53.3%), prior transient ischemic attack (TIA) or stroke (22.7%), prior CABG (28%), and hostile chest (18.7%). In-hospital and 30 day outcomes are shown in TABLE 1.

Conclusions
Subclavian and axillary access TAVR with the Sapien 3 THV is an effective and safe alternative showing high procedural success and low rates of vascular injury. Stroke rates with TAx-TAVR are higher than transfemoral TAVR but similar for TAx-TAVR with self-expandable THVs. To date, this is the largest and only prospective study of TAx-TAVR with Sapien 3.