Valiant thoracic stent-graft deployed with the new captivia delivery system: procedural and 30-day results of the Valiant Captivia registry.

Abstract

PURPOSE:

To evaluate procedural and 30-day outcomes of thoracic endovascular aortic repair (TEVAR) employing the Valiant Thoracic Stent Graft with the Captivia Delivery System.

METHODS:

Enrollment in the study ( www.ClinicalTrials.com identifier NCT01181947) included all eligible patients implanted with the Valiant Captivia System retrospectively and prospectively at 15 sites in Europe and Turkey between October 2009 and June 2010. In the 100 treated patients (81 men; mean age 64.6 ± 12.0 years, range 25-87), indications included descending thoracic aortic aneurysm (TAA, 49.0%) and aortic dissection (42.0%).

RESULTS:

Technical success was 100.0%, with no misaligned deployments or aortic perforations. Mean follow-up was 68.9 ± 34.9 days (range 20-147, median 61). The 30-day rate of all-cause mortality was 4.0% (all 4 cases procedure-related, 3 device-related). Retrograde type A dissection occurred in 2 patients. The only conversion to open surgery was successful in a patient experiencing intraoperative aneurysm rupture. Stroke occurred in 4 (4.0%) patients and paraplegia in 1 (1.0%). Among 66 patients with 30-day imaging studies evaluable for endoleak, 4 (6.1%) had type I and 7 (10.6%) had type II endoleak; there were no types III or IV. Within 30 days, no secondary endovascular procedures were required due to endoleak. One patient with type II endoleak died 3 weeks postimplantation before scheduled embolization.

CONCLUSION:

In this analysis of procedural and 30-day results, the high technical success and clinical outcome rates showed that the Valiant Thoracic Stent Graft with the new Captivia Delivery System has promising capacity to treat a variety of thoracic aortic conditions in a range of anatomies.

• Authors: Robin H Heijmen, Matt M Thompson, Rossella Fattori, Yigit Goktay, Omke E Teebken, Karl Heinz Orend
• Journal: Journal of endovascular therapy : an official journal of the International Society of Endovascular Specialists (J Endovasc Ther) Vol. 19 Issue 2 Pg. 213-25 (Apr 2012) ISSN: 1545-1550 [Electronic] United States
• PMID: 22545887 (Publication Type: Evaluation Study, Journal Article, Multicenter Study, Research Support, Non-U.S. Gov't)

Topics

• Adult
• Aged
• Aged, 80 and over
• Aortic Dissection (surgery)
• Aneurysm, Ruptured (etiology, therapy)
• Aorta, Thoracic (injuries, surgery)
• Aortic Aneurysm, Thoracic (surgery)
• Aortic Diseases (mortality, surgery)
• Blood Vessel Prosthesis
• Blood Vessel Prosthesis Implantation (adverse effects, instrumentation, mortality)
• Endoleak (etiology, therapy)
• Endovascular Procedures (adverse effects, instrumentation, mortality)
• Europe
• Female
• Humans
• Male
• Middle Aged
• Prospective Studies
• Prosthesis Design
• Registries
• Reoperation
• Retrospective Studies
• Stents
• Stroke (etiology, therapy)
• Time Factors
• Treatment Outcome
• Vascular System Injuries (surgery)