Daniel P O'Hair1, Tanvir K Bajwa2, Jeffrey J Popma3, Daniel R Watson4, Steven J Yakubov5, David H Adams6, Samin Sharma7, Newell Robinson8, George Petrossian9, Michael Caskey10, Timothy Byrne11, Neal S Kleiman12, Angie Zhang13, Michael J Reardon14. 1. Department of Cardiothoracic Surgery, Aurora St. Luke's Medical Center, Milwaukee, Wisconsin. Electronic address: daniel.ohair@aurora.org. 2. Department of Cardiology, Aurora St. Luke's Medical Center, Milwaukee, Wisconsin. 3. Department of Internal Medicine, Cardiovascular Division, Beth Israel Deaconess Medical Center, Boston, Massachusetts. 4. Department of Cardiothoracic Surgery, OhioHealth, Riverside Methodist Hospital, Columbus, Ohio. 5. Department of Cardiology, OhioHealth, Riverside Methodist Hospital, Columbus, Ohio. 6. Department of Cardiothoracic Surgery, Mount Sinai Health System, New York, New York. 7. Department of Cardiology, Mount Sinai Health System, New York, New York. 8. Department of Cardiothoracic Surgery, St. Francis Hospital, Roslyn, New York. 9. Department of Cardiology, St. Francis Hospital, Roslyn, New York. 10. Department of Cardiothoracic Surgery, Banner Good Samaritan Regional Medical Center, Phoenix, Arizona. 11. Department of Cardiology, Banner Good Samaritan Regional Medical Center, Phoenix, Arizona. 12. Department of Cardiology, Houston Methodist DeBakey Heart & Vascular Center, Houston, Texas. 13. Coronary and Structural Heart, Medtronic, Mounds View, Minnesota. 14. Department of Cardiovascular Surgery, Houston Methodist DeBakey Heart & Vascular Center, Houston, Texas.
Abstract
BACKGROUND: Transcatheter aortic valve replacement (TAVR) using a self-expanding valve has been shown to be superior to an open operation in high-risk patients. Extensive iliofemoral peripheral vascular disease can prohibit femoral access. In these cases, direct aortic (DA) implantation may be a suitable option. METHODS: The current analysis compared outcomes in patients undergoing TAVR with the self-expanding CoreValve prosthesis (Medtronic, Minneapolis, MN) by direct aortic (DA) access vs iliofemoral (IF) access. Patients treated in the CoreValve US High Risk and Extreme Risk Pivotal Trials and Continued Access Study were included. Propensity score matching was used to account for differences in baseline characteristics between groups. Clinical outcomes were compared at 30 days and 1 year. RESULTS: We identified 394 matched pairs of IF and DA patients. The all-cause mortality rate was significantly higher in the DA group than in the IF group at 30 days (10.9% vs 4.1%, p < 0.001), but this difference was reduced at 1 year (28.1% vs 23.2%, p = 0.063). All-cause mortality or major stroke was significantly higher for DA vs IF access at 30 days (13.5% vs 5.3%, p < 0.001) and at 1 year (30.4% vs 24.2%, p = 0.025). Major/life-threatening bleeding and acute kidney injury were significantly greater in the DA group at 30 days (66.7% vs 35.4% and 19.7% vs 10.0%, respectively, both p < 0.001). CONCLUSIONS: When femoral access is not feasible, DA access allows effective delivery of the valve but incurs an increased risk of death and adverse events, potentially the result of procedural differences.
BACKGROUND: Transcatheter aortic valve replacement (TAVR) using a self-expanding valve has been shown to be superior to an open operation in high-risk patients. Extensive iliofemoral peripheral vascular disease can prohibit femoral access. In these cases, direct aortic (DA) implantation may be a suitable option. METHODS: The current analysis compared outcomes in patients undergoing TAVR with the self-expanding CoreValve prosthesis (Medtronic, Minneapolis, MN) by direct aortic (DA) access vs iliofemoral (IF) access. Patients treated in the CoreValve US High Risk and Extreme Risk Pivotal Trials and Continued Access Study were included. Propensity score matching was used to account for differences in baseline characteristics between groups. Clinical outcomes were compared at 30 days and 1 year. RESULTS: We identified 394 matched pairs of IF and DApatients. The all-cause mortality rate was significantly higher in the DA group than in the IF group at 30 days (10.9% vs 4.1%, p < 0.001), but this difference was reduced at 1 year (28.1% vs 23.2%, p = 0.063). All-cause mortality or major stroke was significantly higher for DA vs IF access at 30 days (13.5% vs 5.3%, p < 0.001) and at 1 year (30.4% vs 24.2%, p = 0.025). Major/life-threatening bleeding and acute kidney injury were significantly greater in the DA group at 30 days (66.7% vs 35.4% and 19.7% vs 10.0%, respectively, both p < 0.001). CONCLUSIONS: When femoral access is not feasible, DA access allows effective delivery of the valve but incurs an increased risk of death and adverse events, potentially the result of procedural differences.