Secondary Procedures following Thoracic Aortic Stent Grafting in the First 3 Years of the VALOR Test and VALOR II Trials

Matsumoto, Alan H.; Angle, John F.; Secic, Michelle; Carlson, Grace; Fisher, Lois; Fairman, Ronald M.

doi:10.1016/j.jvir.2013.12.012

Cited by 9 publications

(11 citation statements)

References 20 publications

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“…Because the earlier trials started enrollment in 2006 and 2007, there is a certain degree of improvement expected over time. 14 Increased operator experience and proficiency in endovascular repair is associated with better outcomes 6,15 and this also likely benefitted the patients in the Valiant Evo trials.…”

Section: Discussionmentioning

confidence: 99%

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

Azizzadeh

Desai

Arko

et al. 2019

Journal of Vascular Surgery

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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.)

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Section: Discussionmentioning

confidence: 99%

“…[3][4][5] In addition, TEVAR outcomes are continuously improving over time as a result of increased operator experience and evolution of stent graft designs and accompanying equipment. 6 As a result, TEVAR is widely accepted as the standard of care for TAAs. A current limitation for the TEVAR procedure can be the patient's anatomic characteristics.…”

mentioning

confidence: 99%

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

Azizzadeh

Desai

Arko

et al. 2019

Journal of Vascular Surgery

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“…Again, the VALOR trials for zone 3 repair provide data with 6% of secondary type I endoleaks after 24 months. 21 One explanation for the lack of secondary endoleak occurrence in the literature might be the short follow-up period in their series. 2,5 Three of four patients with secondary type Ia endoleak in our analysis underwent endovascular repair with proximal endograft implantation, two of them successfully.…”

Section: Discussionmentioning

confidence: 92%

“…In addition, it seems surprising that the rate of primary type Ia endoleaks is similar in the literature for zone 3 repair (Evaluation of the Medtronic Vascular Talent Thoracic Stent Graft System for the Treatment of Thoracic Aortic Aneurysms [VALOR] trials) and for the complex area in the arch. 21 Thoracic device development is still ongoing, but perfect graft placement in hostile aortic arch in >96% seems to be far away from real-world experience.…”

Section: Discussionmentioning

confidence: 99%

Aortic hemiarch hybrid repair

Ockert

Eckstein

Lutz

et al. 2015

Journal of Vascular Surgery

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“…As the successor to the Talent Thoracic Stent Graft System (Medtronic), Valiant has been evaluated in a number of critical research studies specifically aimed at elucidating its feasibility, safety, and effectiveness in the thoracic aorta, all with satisfactory results: VALOR II (US IDE for descending thoracic aneurysms, n=160) [44,45], VIRTUE (European registry for all types of TBADs, n=100) [46–48], the VALIANT CAPTIVIA registry (mid- to high-risk all-comer cohort, n=100) [28], the RESCUE trial (blunt thoracic aortic injury, n=50) [49,50], and the Valiant Mona LSA first-in-human feasibility trial using a modified Valiant Captivia System with branching to allow LSA patency (US FDA IDE via the new Innovation Pathway, n=9) [51]. The VIRTUE registry was a prospective cohort study comparing 3 groups of TBADs: complicated acute (n=50), subacute (n=24), and chronic (n=26).…”

Section: The Us Dissection Trial 3-year Results Of Valiant Captivia Fmentioning

confidence: 99%

Endovascular Repair in Acute Complicated Type B Aortic Dissection: 3-Year Results from the Valiant US Investigational Device Exemption Study

Lim¹

2017

Korean J Thorac Cardiovasc Surg

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Acute complicated type B aortic dissection (TBAD) is a potentially catastrophic, life-threatening condition. If left untreated, there is a high risk of aortic rupture, irreversible organ or limb damage, or death. Several risk factors have been associated with acute complicated TBAD, including age and refractory hypertension. In the acute phase, even uncomplicated patients are more prone to develop complications if hypertension and pain are left medically untreated. Innovations in stent graft technologies have incrementally improved outcomes since their first use for this condition in 1999, though improvement is needed in mitigating periprocedural complications, adverse events, and mortality. In the past decade, endovascular repair has become the preferred treatment because of its superior outcomes to open repair and medical therapy. The Valiant Captivia Thoracic Stent Graft System is a third-generation endovascular stent graft with advancements in minimally invasive delivery, conformability to the anatomy, and the minimization of adverse sequelae. Herein, this stent graft is briefly reviewed and its 3-year outcomes are presented. Freedom from all-cause and dissection-related mortality was 79.1% and 90.0%, respectively. The Valiant Captivia Stent Graft represents a safe, effective intervention for acute complicated TBAD. Continued surveillance is needed to verify its longer-term durability.

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Secondary Procedures following Thoracic Aortic Stent Grafting in the First 3 Years of the VALOR Test and VALOR II Trials

Cited by 9 publications

References 20 publications

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

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

Aortic hemiarch hybrid repair

Endovascular Repair in Acute Complicated Type B Aortic Dissection: 3-Year Results from the Valiant US Investigational Device Exemption Study

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