Outcome analysis of the Gore Conformable Thoracic Stent Graft with active control system for the treatment of arch and descending thoracic aortic disease

Abstract

Abstract OBJECTIVES The aim of this study was to evaluate technical/clinical outcomes of the Gore TAG Conformable Thoracic Stent Graft with Active Control System (CTAG with ACS) in thoracic aortic disease since its introduction in Europe in 2017. METHODS Patients undergoing thoracic endovascular aortic repair (TEVAR) with the device between 2017 and 2020 were identified from a prospectively maintained single-centre database and retrospectively analysed. Predominant indications were aortic dissection (n = 46), thoracic/thoraco-abdominal aneurysm (n = 20/n = 7), penetrating ulcer (n = 14) and intramural haematoma (n = 12). Emergency procedures were performed in 47% (54/115). The primary outcome was technical success. Secondary outcomes were clinical success, serious adverse events and procedure-related reintervention. ACS was assessed regarding angulation, accuracy and apposition. The median follow-up was 8.46 months (interquartile range: 3.18–16.89 months). RESULTS A total of 115 consecutive patients (82 males, median age 63; interquartile range: 53–74 years) have been included. Technical success was achieved in 95.7% (110/115). Clinical success rate was 80.9% (93/115); mostly due to procedure-related death (n = 14). Overall mortality was 19.1% (22/115), with significant differences between elective/emergency procedures (log-rank: P < 0.001). Procedure-related serious adverse event rate was 44.3% (51/115). Procedure-related reintervention was performed in 20.9% (24/115). The cumulative incidence for reintervention differed significantly between elective/emergency cases (Gray’s test: P = 0.0033). Angulation was used in 40.9% of patients (47/115), mostly in type II arches (52.7%). Deployment accuracy was 87.8% (101/115). Sufficient apposition was present in 93.0% (107/115). CONCLUSIONS This single-centre study shows encouraging performance of the CTAG with ACS in an array of aortic pathologies. Although longer-term data must be awaited, ACS leads to overall favourable device placement. Despite ongoing advances in device technology, TEVAR remains challenging and is associated with significant burden inherent to the underlying disease.