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Home > Vascular Annual Meeting^® > PVSS7. Incidence and Outcomes Following Misaligned...

PVSS7. Incidence and Outcomes Following Misaligned Deployment of the Talent Thoracic Endograft

Karthikeshwar Kasirajan, MD; Naren Gupta, MD
Emory University Hospital, Atlanta, GA; Emory University School of Medicine; Atlanta, GA

OBJECTIVES: To assess the etiology and overall impact of proximal stent misalignment following Talent thoracic stent graft (TSG) deployment on the safety and effectiveness of the TSG. This complication refers to one of the proximal stent graft crowns lying retroflexed in an alignment that is not parallel to the wall of the aorta, following complete graft deployment.

METHODS: Data was culled by a direct physician surveys (Outside the United States [OUS] and United States [US]), a targeted literature search, and a review of all Talent TSG complaint filed to Medtronic Vascular (Santa Rosa, CA). Six independent reviewer’s analyzed data on 13 asymmetric deployment reported in 12 patients, including pre and post-op computed tomogram (CT) images.

RESULTS: 9 of these events were reported before the launch of the Talent TSG in the US. Overall, 7 events are from OUS and 6 from the U.S. 7 of these 13 reported events occurred when the device was used outside the proposed U.S. indications for use (dissection 4, inadequate landing zone 1, ascending aorta as landing zone 2), and labeling compliance for one event could not be determined. 4 of these events occurred at the overlap of two stent grafts, and the others occurred at the proximal bare-spring of the proximal most TSG. 9/13 events occurred with the use of large diameter (>40-mms) devices. 2 events were treated intra-operatively with a second overlapping device in one and a snare repositioning of the misaligned stent in the other. Adverse clinical sequel include persistent type I endoleaks in one, and persistent false lumen perfusion in 2 patients with dissection. No intraoperative contrast extravasations or CT evidence of perforation or retrograde dissection was noted in any patients. There were no perioperative deaths with a single report of paraplegia.

CONCLUSIONS: Asymmetric deployment are unusual phenomena that tend to occur most frequently with off-label and/or inappropriate device usage, including deployment technique not in accordance with the IFU. Currently, no major clinical sequelae have been observed as a result of asymmetric opening.

AUTHOR DISCLOSURES: K. Kasirajan, Medtonic; N. Gupta, None.