Anatomical suitability for branched endovascular aortic arch repair and balloon-expandable bridging stent grafts in a cohort of patients previously treated with a hybrid approach.

OBJECTIVE: We assessed the suitability of two triple branch arch devices (aBranch) (Terumo aortic and Cook Medical) and a balloon-expandable covered stent (VBX, W. L. Gore & Associates, Johnson & Johnson) to incorporate the brachiocephalic trunk (BCT) in a cohort previously treated with hybrid thoracic endovascular repair (TEVAR). METHODS: This is a single-center, retrospective, all-comers, preclinical suitability study. We conducted an analysis of preoperative computed tomography scans in surgical patients between 1999 and 2022 in a single vascular surgery unit. The primary outcome was the aortic suitability of aBranch devices and VBX as mating stent for BCT in previous hybrid TEVAR. Hybrid repair of the aortic arch included TEVAR, fenestrated or branched TEVAR associated with any surgical debranching of the supra-aortic trunks and chimney TEVAR with proximal landing in zones 0 to 2. Secondary outcomes included (i) suitability assessment when excluding minor instruction for use (IFU) criteria, (ii) a comparison of suitable and nonsuitable patients, (iii) risk factors analysis for nonsuitability, and (iv) a description of the exclusion causes. RESULTS: During the study period, 120 patients were treated. Among elective patients (n = 73), the suitability of any aBranch was 82.2% (60/73) and VBX was suitable in 64.4% of BCTs (47/73). The aBranch suitable patients had a significantly longer sinotubular-BCT length (P = .017) and smaller distal ascending aorta (P = .043) as compared with nonsuitable ones. The suitability of Terumo Aortic and Cook Medical devices was 52.1% (38/73) and 46.6% (34/73), respectively. When minor IFU criteria were ignored, suitability increased to 82.2% (60/73) and 63.0% (46/73), respectively. Left common carotid artery diameter and sinotubular-BCT length were significant nonsuitability risk factors for Terumo Aortic aBranch in multivariable analysis. No associations were found for Cook Medical device. The outcomes were tested in the entire cohort demonstrating a global suitability of 82.9%, increasing to 86.3% when ignoring minor IFUs. VBX was anatomically suitable to use in BCT in 73.2% of patient BCTs. CONCLUSIONS: aBranch devices are anatomically suitable in a vast majority of patients (86%) undergoing hybrid TEVAR. The innominate artery seems eligible for incorporation with VBX in almost two-thirds of patients. This mating stent may help to overcome some minor IFU restrictions.

Incidence, Long Term Clinical Outcomes, and Risk Factor Analysis of Type III Endoleaks Following Endovascular Repair of Abdominal Aortic Aneurysm.

OBJECTIVE: To assess the real world incidence, outcomes, and risk factors of type III endoleaks (TIIIEL) after endovascular aneurysm repair (EVAR). METHODS: This was a single centre, retrospective, observational, cohort study. All patients with abdominal aortic aneurysms (AAAs) receiving EVAR between 1994 and 2020 were collected prospectively and reviewed. The primary outcome was the cumulative incidence and impact on survival of TIIIELs, either defined as disconnections of modular graft components (TIIIaEL) or fabric defects (TIIIbEL). Secondary outcomes included risk factor analysis evaluating baseline morphological and stent graft details, as well as a comparison of TIIIaEL and TIIIbEL. RESULTS: In total, 2 565 EVARs were performed and 95 (3.7%) TIIIELs were diagnosed at a median interval of 49.5 months (interquartile range [IQR] 19.4, 67.6). Estimated TIIIEL incidence at five years was 6.8%, 2.2%, and 3.6% for first and second generation, third and fourth generation, and fifth and sixth generation, respectively. The survival rate in patients without any high flow endoleak was 88.0%, 67.9%, 56.9%, and 52.1%, while in TIIIEL patients it was 98.6%, 77.2%, 49.8%, and 32.3% at one, five, 10, and 15 years, respectively (p = .77). The distribution of TIIIaEL and TIIIbEL was 70.5% and 29.5%, respectively. TIIIbEL received a higher rate of open treatment (28.6% vs. 7.5%; p = .005) and device or procedure related re-interventions (35.7% vs. 13.4%; p = .013). Fourteen (15.4%) recurrent TIIIELs were diagnosed at a median of 16.8 months (IQR 7.6, 32.1). Old generation endografts (hazard ratio [HR] 2.1, 95% confidence interval [CI] 1.3 - 3.4; p = .002) and non-proprietary extensions (HR 3.6, 95% CI 1.9 - 6.8; p < .001), and angulated and calcified aneurysm neck (HR 3.6, 95% CI 1.2 - 10.6; p = .017) were risk factors for TIIIEL. Every 10 mm maximum AAA diameter increase presented a 1.4 fold higher risk of TIIIEL. CONCLUSION: TIIIEL is a severe condition that is often fatal if left untreated. Old endografts, the implantation of non-proprietary extensions, large AAAs, and angulated and calcified necks are risk factors for TIIIEL that require careful follow up due to the high rate of recurrence.

Balloon Inducted Re-Lamination and False Lumen Thrombosis in Chronic Type B Aortic Dissection: Technique and Long-Term Results.

BACKGROUND: To evaluate the safety, feasibility, and effectiveness of the BAlloon Inducted re-Lamination and false lUmen Thrombosis (BAILOUT) as a simple technique to address the retrograde false lumen (FL) perfusion and subsequent aneurysmatic degeneration of the thoracic aorta due to a stent-graft crimped in a small true lumen in chronic Type B dissections. METHODS: An observational, retrospective, single-center study analyzing a nonconsecutive cohort of 8 patients affected by chronic type B aortic dissections already treated with thoracic endovascular repair and with an FL lumen backflow corrected with BAILOUT between 2006 and 2020. After a standard distal extension of the previously implanted graft, the distal end of the graft area was ballooned to completely rupture the dissection lamella to relaminate the aorta hindering the FL backflow. Computed tomography was routinely performed within the first postoperative week before discharge and then at 3 months, at 6 months, and yearly thereafter. The technical and clinical success rates were analyzed. Primary outcomes were safety and feasibility of the technique, secondary ones included FL thrombosis evaluation, and total aortic diameter analysis at the above-defined levels during the follow-up. Safety was defined if clinical success was reached. Feasibility was intended as technical success obtention. RESULTS: The technical and clinical success achieved was 100% with the complete interruption of FL backflow stating the safety and feasibility of the BAILOUT technique. No early procedure reinterventions were recorded and during a median follow-up of 62.5 months [interquartile range 43.2-94.1], only 1 death unrelated to the procedure was recorded. Freedom from aortic-related adverse events at 1 month, 3 months, 1 year, 5, and 7 years was 87.5%, 62.5%, 62.5%, 62.5%, and 62.5%, respectively. During the follow-up, no one increment of the diameter of the thoracic aorta was documented and all the patients at 3 years of computed tomography angiography showed a complete FL thrombosis. CONCLUSIONS: The BAILOUT technique demonstrates to be safe and feasible in this small cohort of patients as a simple and quick way to overcome the issue of FL backflow in chronic type B dissection. Small cohort and retrospective designs were limitations of the study.