Thomas G Gleason1, John T Schindler2, Robert C Hagberg3, G Michael Deeb4, David H Adams5, John V Conte6, George L Zorn7, G Chad Hughes8, Jia Guo9, Jeffrey J Popma10, Michael J Reardon10. 1. Department of Cardiothoracic Surgery, University of Pittsburgh Medical Center Heart and Vascular Institute, University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania. Electronic address: gleasontg@upmc.edu. 2. Department of Medicine, University of Pittsburgh Medical Center Heart and Vascular Institute, University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania. 3. Department of Cardiac Surgery, University of Michigan Hospitals, Ann Arbor, Michigan. 4. Department of Cardiovascular Surgery, Mount Sinai Health System, New York, New York. 5. Division of Cardiac Surgery, The Johns Hopkins University, Baltimore, Maryland. 6. Department of Cardiothoracic Surgery, University of Kansas, Lawrence, Kansas. 7. Department of Thoracic and Cardiac Surgery, Duke University Medical Center, Durham, North Carolina. 8. Statistical Services, Medtronic, Mounds View, Minnesota. 9. Cardiovascular Division, Department of Internal Medicine and Cardiovascular Surgery, and Department of Surgery, Beth Israel Deaconess Medical Center, Boston, Massachusetts. 10. Department of Cardiovascular Surgery, The Methodist DeBakey Heart and Vascular Center, Houston, Texas.
Abstract
BACKGROUND: Iliofemoral arterial disease can preclude transfemoral (TF) transcatheter aortic valve replacement (TF-TAVR). Transthoracic access by direct aortic or a transapical approach imparts a greater risk of complications and death than TF access. We hypothesized that subclavian/axillary arterial (SCA) access offers equivalent risks and outcomes as TF access. METHODS: The outcomes of 202 patients from the CoreValve (Medtronic, Minneapolis, MN) United States Pivotal Trial Program treated with SCA access were propensity matched with patients treated with TF access and analyzed. RESULTS: Matching was successful, with no significant baseline differences in the SCA group and the TF group, except the SCA group had more past or present smokers (79.2% vs 61.4%, p < 0.001) and fewer patients with anemia requiring transfusion (18.5% vs 27.5%, p = 0.04). SCA patients experienced a significantly longer time from enrollment to procedure (8.6 ± 19.1 vs 5.3 ± 6.3 days; p = 0.02), likely the result of case planning. Significant differences in procedural outcomes include less post-TAVR balloon dilation (17.9% vs 26.7%, p = 0.03) and more general anesthesia (99.0% vs 89.6%, p < 0.001) for the SCA accesses. There were no differences in procedure time (57.8 ± 45.3 vs 57.5 ± 32.1 min, p = 0.94) or Valve Academic Research Consortium I-defined procedure success between groups (p = 0.89). Event rates at 30 days or 1 year were similar, with a trend toward fewer pacemakers with SCA accesses. CONCLUSIONS:Major morbidity and mortality rates SCA-TAVR are equivalent to TF-TAVR. The SCA should be the preferred secondary access site for TAVR because it offers procedural and clinical outcomes comparable to TF-TAVR and applies to most patients who are not TF candidates.
RCT Entities:
BACKGROUND: Iliofemoral arterial disease can preclude transfemoral (TF) transcatheter aortic valve replacement (TF-TAVR). Transthoracic access by direct aortic or a transapical approach imparts a greater risk of complications and death than TF access. We hypothesized that subclavian/axillary arterial (SCA) access offers equivalent risks and outcomes as TF access. METHODS: The outcomes of 202 patients from the CoreValve (Medtronic, Minneapolis, MN) United States Pivotal Trial Program treated with SCA access were propensity matched with patients treated with TF access and analyzed. RESULTS: Matching was successful, with no significant baseline differences in the SCA group and the TF group, except the SCA group had more past or present smokers (79.2% vs 61.4%, p < 0.001) and fewer patients with anemia requiring transfusion (18.5% vs 27.5%, p = 0.04). SCA patients experienced a significantly longer time from enrollment to procedure (8.6 ± 19.1 vs 5.3 ± 6.3 days; p = 0.02), likely the result of case planning. Significant differences in procedural outcomes include less post-TAVR balloon dilation (17.9% vs 26.7%, p = 0.03) and more general anesthesia (99.0% vs 89.6%, p < 0.001) for the SCA accesses. There were no differences in procedure time (57.8 ± 45.3 vs 57.5 ± 32.1 min, p = 0.94) or Valve Academic Research Consortium I-defined procedure success between groups (p = 0.89). Event rates at 30 days or 1 year were similar, with a trend toward fewer pacemakers with SCA accesses. CONCLUSIONS: Major morbidity and mortality rates SCA-TAVR are equivalent to TF-TAVR. The SCA should be the preferred secondary access site for TAVR because it offers procedural and clinical outcomes comparable to TF-TAVR and applies to most patients who are not TF candidates.
Authors: Robert J Lederman; Vasilis C Babaliaros; John C Lisko; Toby Rogers; Paul Mahoney; Jason R Foerst; Jeremiah P Depta; Kamran I Muhammad; James M McCabe; Andrei Pop; Jaffar M Khan; Christopher G Bruce; Giorgio A Medranda; Jane W Wei; Jose N Binongo; Adam B Greenbaum Journal: JACC Cardiovasc Interv Date: 2022-05-09 Impact factor: 11.075