Ali Azizzadeh1, Nimesh Desai2, Frank R Arko3, Jean M Panneton4, Fabien Thaveau5, Paul Hayes6, Francois Dagenais7, Lanyu Lei8, Fabio Verzini9. 1. Cedars-Sinai Medical Center, Los Angeles, Calif. Electronic address: ali.azizzadeh@cshs.org. 2. Division of Cardiovascular Surgery, University of Pennsylvania, Philadelphia, Pa. 3. Carolinas Medical Center, Charlotte, NC. 4. Department of Vascular Surgery, Eastern Virginia Medical School, Norfolk, Va. 5. Department of Vascular Surgery and Kidney Transplantation, Strasbourg University Hospital, Strasbourg, France. 6. Department of Surgery, Cambridge University Hospital, Cambridge, United Kingdom. 7. Division of Cardiac Surgery, University of Quebec, Quebec City, Canada. 8. Division of Aortic Peripheral and Endovenous, Medtronic Inc, Santa Rosa, Calif. 9. Department of Vascular Surgery, University of Turin, Turin, Italy.
Abstract
OBJECTIVE: The Valiant Navion stent graft system (Medtronic, Santa Rosa, Calif) is a new iteration of a thoracic endograft for the treatment of descending thoracic aortic aneurysms. Herein, the 30-day primary safety and efficacy outcomes and secondary end points are presented. METHODS: The Valiant EVO global clinical trial is a prospective, nonrandomized, single-arm trial. Patient enrollment occurred from April 2016 to October 2017. The primary end point was defined as access and/or deployment failure and/or a major device effect (MDE), including device-related secondary procedures, device-related mortality, conversion to open surgery, or thoracic aortic aneurysm rupture within 30 days of the index procedure. Other measures of stent graft performance including procedural data, rates of secondary procedures, and frequency of endoleaks are also reported. RESULTS: Of the 87 consecutive patients undergoing thoracic endovascular aneurysm repair who were enrolled, 33 (37.9%) were female with 61 (70.9%) presenting with severe access artery tortuosity and 66 (85.7%) with high thoracic aortic tortuosity per core laboratory evaluation. The mean procedure duration was 88.7 ± 53.4 minutes and geographical differences existed such as percutaneous access (37/52 [71.2%]) in the United States and surgical cut down in the outside of the U.S. sites (28/35 [80.0%]). There were no access or deployment failures and only 2.3% of the patients (2/87; P < .0001; performance goal of 16%) experienced a MDE within 30 days of the index procedure. Two secondary procedures (n = 1 retrograde type A dissection; n = 1 aortic arch rupture) were required, and in the first 30 days, two patients died leading to a freedom from all-cause mortality of 97.7%. Endoleaks at 1 month were reported in 2.5% of patients (n = 1 type Ia; n = 1 type II). CONCLUSIONS: Access/deployment failures, MDEs, and endoleaks were rare in the first 30 days of the Valiant Evo clinical trial. The Valiant Navion thoracic stent graft system has shown encouraging 30-day results in this challenging cohort and trial patients will continue to be followed through 5 years.
OBJECTIVE: The Valiant Navion stent graft system (Medtronic, Santa Rosa, Calif) is a new iteration of a thoracic endograft for the treatment of descending thoracic aortic aneurysms. Herein, the 30-day primary safety and efficacy outcomes and secondary end points are presented. METHODS: The Valiant EVO global clinical trial is a prospective, nonrandomized, single-arm trial. Patient enrollment occurred from April 2016 to October 2017. The primary end point was defined as access and/or deployment failure and/or a major device effect (MDE), including device-related secondary procedures, device-related mortality, conversion to open surgery, or thoracic aortic aneurysm rupture within 30 days of the index procedure. Other measures of stent graft performance including procedural data, rates of secondary procedures, and frequency of endoleaks are also reported. RESULTS: Of the 87 consecutive patients undergoing thoracic endovascular aneurysm repair who were enrolled, 33 (37.9%) were female with 61 (70.9%) presenting with severe access artery tortuosity and 66 (85.7%) with high thoracic aortic tortuosity per core laboratory evaluation. The mean procedure duration was 88.7 ± 53.4 minutes and geographical differences existed such as percutaneous access (37/52 [71.2%]) in the United States and surgical cut down in the outside of the U.S. sites (28/35 [80.0%]). There were no access or deployment failures and only 2.3% of the patients (2/87; P < .0001; performance goal of 16%) experienced a MDE within 30 days of the index procedure. Two secondary procedures (n = 1 retrograde type A dissection; n = 1 aortic arch rupture) were required, and in the first 30 days, two patients died leading to a freedom from all-cause mortality of 97.7%. Endoleaks at 1 month were reported in 2.5% of patients (n = 1 type Ia; n = 1 type II). CONCLUSIONS: Access/deployment failures, MDEs, and endoleaks were rare in the first 30 days of the Valiant Evo clinical trial. The Valiant Navion thoracic stent graft system has shown encouraging 30-day results in this challenging cohort and trial patients will continue to be followed through 5 years.