Pivotal results for the Valiant Navion stent graft system in the Valiant EVO global clinical trial

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 6 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 ¼ 1 retrograde type A dissection; n ¼ 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 ¼ 1 type Ia; n ¼ 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. (J Vasc Surg 2019;70:1399-408.)

Early results of a low-profile stent-graft for thoracic endovascular aortic repair

“…These results are favorable and/or comparable to what has been reported so far with other latest-generation or low-profile devices. There was no 30-day mortality as compared to 2.3%, 9% and 10% reported by other authors [20,22,23]. We saw no aortic rupture or stent fractures, again in line with the low incidences reported to date (1% and 1.1% for rupture and 0.9% for fracture) [20][21][22].…”

“…There were no adjunctive techniques in this series despite a mean access vessel diameter of 7.7 ± 1.32 mm (range 0.5-1); compared with 9.1 (6-13) mm previously reported with RelayPro [10]. Most patients had severe iliac and aortic tortuosity but there was no vessel-access related complication in this series, confirming a generally low incidence with all the low-profile devices reported so far: 3% [23], 5.7% [20], 6% [10] and 7% [22].…”

“…Almost 90% of implants were percutaneous in a later study of 70 patients treated with the Zenith Alpha and 22.3 ± 15.9 months follow-up: 6% required balloon dilation of the iliac arteries, 4% required iliofemoral conduit: 4% had access vessel complications [19]. In 87 patients (40% female) treated with the Valiant Navion, 51% were accessed percutaneously, four patients required iliac stenting and there was no access or deployment failure [20]. In a European multicenter registry of 100 patients treated with a Gore cTAG (18-24F), iliac conduits were needed in 5% of patients [22].…”

“…Much progress to lower profile stent-grafts has already been made and the Cook Medical Zenith Alpha and Medtronic Valiant Navion (both 18-22/23F outer diameter) have demonstrated encouraging early and midterm results [19,20]. In a prospective study of 110 patients (42% women, 38% Asian) treated with the Zenith Alpha, mean access vessel diameter was 6.7 ±1.6 mm and 36% of implants were percutaneous [21].…”

One-Year Results From the SURPASS Observational Registry of the CTAG Stent-Graft With the Active Control System

“…However, the anatomy of the included patients was not particularly demanding in terms of landing zone, tortuosity, or calcification. 16 In a midterm evaluation of a single-center experience of 70 patients treated with Cook's Zenith Alpha thoracic stentgraft, ongoing clinical success was 87.1% at a mean followup of 22.3 months. 17 However, there is no information on the exact localization of the aortic pathologies.…”