Landing Zone Diameter Research Articles

Anatomic feasibility of a novel modular triple-branched endograft for patients with aortic arch pathologies

ABSTRACT Objectives This study aimed to assess the anatomical feasibility of a novel modular triple-branched endograft for aortic arch diseases. Methods A cross-sectional study was conducted on 314 patients with aortic arch pathologies treated at a single center from January 2018 to December 2023. Preoperative computed tomography angiography images were analyzed with three-dimensional reconstruction to quantify anatomical features. Feasibility was based on endograft anatomical criteria, and logistic regression identified risk factors for unsuitability. Results Out of 132 patients included in the study, 67.4% were deemed anatomically suitable for the triple-branched device. A total of 36 (27.3%) patients were deemed inapplicable due to a large diameter of the proximal landing zone, 12 (9%) patients due to a small diameter of the left common carotid artery, and 1 (0.8%) patient due to a small diameter of the left subclavian artery. Logistic regression identified large proximal landing zone diameter and small left common carotid artery diameter were significant factors for unsuitability (p < 0.001 and p = 0.002, respectively). Conclusions The novel triple-branched endograft demonstrated promising anatomical feasibility in two-thirds of patients. However, anatomical constraints limited its applicability. Future device iterations should focus on accommodating a broader range of anatomical variations.

Comparative effectiveness of Castor single-branch stent and hybrid surgery for the left subclavian artery in managing acute Type B aortic dissection with an inadequate proximal landing zone

Abstract Background Our study aims to compare the clinical outcomes and risk factors for adverse events between TEVAR with branch stent-graft and Hybrid surgery for the reconstruction of the left subclavian artery. Methods We retrospectively analyzed data from patients with insufficient proximal landing zones of acute Type B aortic dissection treated at our hospital from January 2017 to December 2022. According to the surgical method, patients were divided into TEVAR group (n=58) and Hybrid group (n=69). The primary endpoint was all-cause mortality. Results The diameter of the proximal landing zone in the TEVAR group was larger than that in the Hybrid group (31.5mm vs 30.3mm, P=0.037). Early Results: There was no significant difference in major adverse events and 30-day mortality between the TEVAR and Hybrid groups. The Hybrid group had significantly longer surgery time (110min vs 238min), hospital stay (8d vs 12d), and ICU stay (0d vs 1d) compared to the TEVAR group (P&amp;lt;0.001). Mid-Term Results: There was no statistical difference in mid-term mortality rates (3.4% vs 8.7%; P=0.398) between the TEVAR and Hybrid groups. The rate of mid-term adverse events was significantly higher in the Hybrid group compared to the TEVAR group (23.2% vs 6.9%; P=0.023). The rate of re-intervention was significantly higher in the Hybrid group compared to the TEVAR group (17.4% vs 3.4%; P=0.027). The 18-month freedom from mid-term adverse event rate was 93.1% (95% CI, 86.4% - 99.8%) for the TEVAR group and 76.8% (95% CI, 66.6% - 87.0%) for the Hybrid group. There was a significant difference in the rate of mid-term adverse events between the TEVAR and Hybrid groups, with the Hybrid group being higher (6.9% vs 23.2%, P=0.013). COX regression results showed: Diameter of the proximal landing zone (HR=0.6, 95%CI=0.4–0.9, P=0.009) was an independent risk factor for postoperative aortic-related adverse events. Conclusions TEVAR reconstruction of LSA and hybrid surgery are both safe and effective treatments for acute Type B aortic dissection with insufficient proximal landing zones. There is no difference in early adverse events and 30-day mortality rates between TEVAR reconstruction of LSA and hybrid surgery. Compared to hybrid surgery, TEVAR reconstruction of LSA has the advantages of shorter operation time, hospital stay, and ICU duration. There is no difference in aortic-related mortality and all-cause mortality between TEVAR reconstruction of LSA and hybrid surgery. However, TEVAR has significantly lower rates of mid-term adverse events and re-intervention compared to the hybrid group. The diameter of the proximal landing zone are risk factors for all-cause mortality.

Modified upside-down technique with Gore tapered iliac limbs for isolated iliac artery aneurysms.

To describe the off-label use of tapered iliac limbs for the treatment of isolated iliac aneurysms with proximal landing zone significantly larger than distal landing zone. Inversion of a Gore Excluder tapered leg (W. L. Gore & Associates Inc, Flagstaff, Arizona) with a modified upside-down technique is described. The endoprosthesis, with the olive at the tip of the releasing system previously cut, is inserted in a tip-to-tip fashion into a 15 Fr introducer sheath. The graft is released inside the introducer. An 18 Fr introducer sheath is advanced up to the proximal sealing zone. Following the removal of the 18 Fr dilator, the 15 Fr introducer with the pre-released graft is inserted co-axially into the 18 Fr introducer. A pre-cut 15 Fr dilator is brought up to the endograft and used as a pusher. A pull-back maneuver of the co-axial system, countertractioning with the dilator maintained in position, allows the delivery of the endograft. This technique might offer a feasible option in case of endovascular exclusion of isolated iliac artery aneurysms with significant landing zone diameter mismatch. Extracorporeal inversion is time-saving and could be safer in terms of graft damage and infection.

Comparison of left atrial appendage measurements between conventional transesophageal echocardiography and "Virtual TEE" reconstructed from computed tomography for pre-procedural planning of device closure.

For pre-procedural planning of left atrial appendage (LAA) closure, sizing is crucial. Although transesophageal echocardiography (TEE) is a standard modality, cardiac computed tomography (CT) is also widely used. The virtual TEE (V-TEE) that our group developed enables us to reconstruct images similar to TEE images from CT images. The software should be helpful to understand and plan the procedure strategy. Accordingly, we investigated the utility of V-TEE. Sixty-six patients at 4 participating sites who completed both CT and TEE prior to LAA closure were included. The LAA diameter at the landing zone (LZ) for WATCHMAN™ device implantation was statistically compared at 0°, 45°, 90°, and 135° between V-TEE and TEE. Among 66 cases, only 3 cases were excluded due to poor imaging quality, and 63 cases were analyzed. The device LZ diameters based on V-TEE were strongly correlated with those based on TEE, despite the significantly greater diameter based on V-TEE with mean differences of 2.4 to 3.0mm (all of them: P < 0.001). The discordances (V-TEE/TEE ratio) at most angles were significantly larger in the elliptical LAAs. V-TEE provides a valuable method for the evaluation of the LAA diameters. V-TEE-based measurements were larger than conventional TEE-based measurements, especially in cases of elliptical LAAs. The assessment by V-TEE has the potential benefit of ensuring proper device sizing regardless of the LAA morphology.

Type III aortic arch angulation increases aortic stiffness: Analysis from an ex vivo porcine model

ObjectiveThe relationship among increased aortic arch angulation, aortic flow dynamics, and vessel wall stiffness remains unclear. This experimental ex vivo study investigated how increased aortic arch angulation affects aortic stiffness and stent-graft induced aortic stiffening, assessed by pulse wave velocity (PWV). MethodsPorcine thoracic aortas were connected to a circulatory mock loop in a Type I and Type III aortic arch configuration. Baseline characteristics and blood pressures were measured. Proximal and distal flow curves were acquired to calculate PWV in both arch configurations. After that, a thoracic stent-graft (VAMF2626C100TU) was deployed in aortas with adequate proximal landing zone diameters to reach 10% t0 20% oversizing. Acquisitions were repeated for both arch configurations after stent-graft deployment. ResultsTwenty-four aortas were harvested, surgically prepared, and mounted. Cardiac output was kept constant for both arch configurations (Type I: 4.74 ± 0.40 and Type III: 4.72 ± 0.38 L/minute; P = .703). Compared with a Type I arch, aortic PWV increased significantly in the Type III arch (3.53 ± 0.40 vs 3.83 ± 0.40 m/second; P < .001), as well as blood pressures. A stent-graft was deployed in 15 aortas. After deployment, Type I arch PWV increased (3.55 ± 0.39 vs 3.81 ± 0.44 m/second; P < .001) and Type III arch PWV increased although not significantly (3.86 ± 0.42 vs 4.03 ± 0.46 m/second; P = .094). Type III arch PWV resulted the highest and significantly higher compared with the Type I arch after stent-graft deployment (3.81 ± 0.44 vs 4.03 ± 0.46 m/second; P = .023). ConclusionsIncreased aortic arch angulation—as in a Type III arch—is associated with higher aortic PWV and blood pressures and this may negatively influence cardiovascular health.

Mechanisms, predictors, and evolution of severe peri-device leaks with two different left atrial appendage occluders.

Incomplete left atrial appendage occlusion (LAAO) due to peri-device leak (PDL) is a limitation of the therapy. The Amulet IDE trial is the largest randomized head-to-head trial comparing the Amulet and Watchman 2.5 LAAO devices with fundamentally different designs. The predictors and mechanistic factors impacting differences in PDLs within the Amulet IDE trial are assessed in the current analysis. An independent core lab analysed all images for the presence or absence of severe PDL (>5 mm). The incidence, mechanistic factors, predictors using propensity score-matched controls, and evolution of severe PDLs through 18 months were assessed. Of the 1878 patients randomized in the trial, the Amulet occluder had significantly fewer severe PDLs than the Watchman device at 45 days (1.1 vs. 3.2%, P < 0.001) and 12 months (0.1 vs. 1.1%, P < 0.001). Off-axis deployment or missed lobes were leading mechanistic PDL factors in each device group. Larger left atrial appendage (LAA) dimensions including orifice diameter, landing zone diameter, and depth predicted severe PDL with the Watchman device, with no significant anatomical limitations noted with the Amulet occluder. Procedural and device implant predictors were found with the Amulet occluder attributed to the learning curve with the device. A majority of Watchman device severe PDLs did not resolve over time through 18 months. The dual-occlusive Amplatzer Amulet LAA occluder provided improved LAA closure compared with the Watchman 2.5 device. Predictors and temporal observations of severe PDLs were identified in the Amulet IDE trial. https://clinicaltrials.gov Unique identifier NCT02879448.

Pericardial effusion following percutaneous left atrial appendage closure using the LAmbre device.

Pericardial effusion (PE) is an uncommon but serious complication that occurs following percutaneous left atrial appendage closure (LAAC). There are few data regarding PE following implantation of the LAmbre device for LAAC. Patients with nonvalvular atrial fibrillation (AF) undergoing percutaneous LAAC using the LAmbre device at the Arrhythmia Center of Ningbo First Hospital from October 2017 to March 2021 were retrospectively reviewed (n = 133). PE was defined as acute if diagnosed ≤7 days post LAAC (n = 3, 2.3%) or delayed if diagnosed >7 days post LAAC (n = 3, 2.3%). The clinical characteristics and procedural data were compared between patients with PE (PE group, n = 6) and without PE (non-PE group, n = 127). The predictors of PE were analyzed by logistic regression. All patients with PE recovered following treatment by pericardiocentesis. Patients with PE were found to have a higher incidence of congestive heart failure (50.0% vs. 13.4%, P = 0.044) and had larger measured LAA orifice diameters (33.5 mm ± 6.0 mm vs. 28.3 mm ± 5.2 mm, P = 0.018) and landing zone diameters (27.8 mm ± 4.8 mm vs. 23.9 mm ± 4.8 mm, P = 0.054) compared with those without PE. The diameters of the device umbrellas (31.7 mm ± 5.6 mm vs. 26.9 mm ± 5.0 mm, P = 0.026) and covers (36.3 mm ± 4.6 mm vs. 33.4 mm ± 4.0 mm, P = 0.075) implanted were larger in the PE group compared to the non-PE group. Univariate logistic regression revealed that congestive heart failure (OR = 6.47, 95% CI = 1.21-34.71, P = 0.029) and LAA maximal orifice diameter (OR = 1.22, 95% CI = 1.02-1.45, P = 0.027) were both associated with PE following LAmbre device implantation. In this single-center experience, both acute and delayed PE were uncommon in patients with AF following LAmbre device implantation. Congestive heart failure and a larger LAA orifice were identified as predictors for the occurrence of PE.

Global Iliac Branch Study: Image-based Detailed Anatomic Assessment and Device Performance

Global Iliac Branch Study: Image-based Detailed Anatomic Assessment and Device Performance

PO-04-065 THREE-DIMENSIONAL INTRACARDIAC ECHOCARDIOGRAPHY FOR LEFT ATRIAL APPENDAGE SIZING AND PERCUTANEOUS OCCLUSION GUIDANCE

PO-04-065 THREE-DIMENSIONAL INTRACARDIAC ECHOCARDIOGRAPHY FOR LEFT ATRIAL APPENDAGE SIZING AND PERCUTANEOUS OCCLUSION GUIDANCE

Endovascular repair in type A aortic dissection: Anatomic candidacy for currently manufactured stentgrafts and conceptual valve-carrying devices for an Endo-Bentall procedure.

Endovascular treatment has been suggested as alternative for open surgery as treatment for type A aortic dissection, but current devices have severe anatomic limitations. This study assesses computed-tomography-based anatomic suitability of currently manufactured stent grafts as well as two embodiments of valve-carrying devices. In a retrospective single-center cohort of 200 consecutive ascending/arch operations between 2009 and 2018, 112 type A aortic dissection patients were identified and evaluated for endovascular candidacy based on locations of entries, landing zone diameters/lengths and supra-aortic vessel origins according to the anatomical instructions for use criteria of 6 commercially available, (tubular, branched or fenestrated) stentgrafts. Two suggested valve-carrying devices with inner branches or fenestrations for the coronary arteries and branches for the supra-aortic vessels were also evaluated. The anatomic feasibility for commercial stentgrafts ranged from 4% to 21%. The main limitations was proximal landing zone diameter (considering oversizing <15%) and length due to dilatation and an entry too close to the sinotubular junction. For the valve-carrying conduits, anatomical feasibility was between 31% and 80%. with the main limiting factors the diameter of the aortic annulus and its distance to the coronary arteries. Anatomic applicability of currently manufactured stentgrafts for the treatment of type A aortic dissection is mainly limited by the absence of a suitable proximal landing zone in the ascending aorta and might substantially be improved by anchoring in the aortic annulus using a valve-carrying device which employs either fenestrations or branches for the coronary arteries.

Endovascular abdominal aortic aneurysm repair with a new stent graft:early results from a multicenter study

Objective: To examine the safety and effectiveness of a new stent graft system for endovascular repair of abdominal aortic aneurysm(AAA). Methods: This is a prospective,multi-center,single-arm clinical trial. The patients with AAA treated with a new stent graft system were enrolled at 21 centers from September 2018 to September 2019 in China. Follow-up was performed before discharge, and at 30, 180, 360 days after operation, respectively. The primary safety endpoint was the incidence of major adverse events(MAE) within 30 days. The primary efficacy endpoint was the success rate of AAA treatment at 360 days. Secondary safety endpoints were the incidence of perioperative access complications and acute lower limb ischemia,all-cause mortality, AAA related mortality and incidence of serious adverse events (SAE) at 180 and 360 days. Secondary efficacy endpoints were the incidence of type Ⅰ or Ⅲ endoleak,stent displacement,and conversion to open surgery or re-intervention at 180 and 360 days. Results: One hundred and fifty-six patients were enrolled,including 137 males and 19 females. The age was (68.9±6.9) years (range:48.2 to 84.6 years).Maximum aneurysm diameter was (50.8±11.2) mm (range:25.0 to 85.0 mm),diameter of proximal landing zone was (21.2±2.5) mm (range:17.0 to 29.5 mm),and length of proximal landing zone was (31.4±13.0) mm (range:11.0 to 75.0 mm).The incidence of MAE was 1.3% (2/156) at 30 days,both were all-cause death cases. The success rate of AAA treatment was 88.5% (138/156) at 360 days. No perioperative access complication and acute lower limb ischemia occurred. All-cause mortality was 2.0% (3/154) at 180 days and 2.6% (4/153) at 360 days,and there was no AAA related death. The incidence of SAE was 23.0%(35/152) at 180 days and 30.5%(46/151) at 360 days, and no device-related SAE occurred. The incidence of type Ⅰor Ⅲ endoleak was 3.4% (5/147) at 180 days and 3.5% (5/144) at 360 days. Conclusion: The new stent graft system is easy to operate,and early-term safety and effectiveness results are expected.

Real-time 3D echocardiographic transilluminated imaging combined with artificially intelligent left atrial appendage measurement for atrial fibrillation interventional procedures.

Aims: This study investigated the feasibility and accuracy of real-time three-dimensional (3D) echocardiographic transilluminated imaging (TrueVue Glass) in left atrial appendage (LAA) anatomical morphology and artificial intelligence (AI)-assisted 3D automated LAA measurement (3D Auto LAA) software in the preoperative evaluation of LAA occlusion (LAAO) in patients with atrial fibrillation (AF). Method and results: Thirty-seven patients with AF were selected. Two-dimensional (2D) and real-time 3D transesophageal echocardiography (RT3D-TEE) were performed preoperatively, using conventional 3D, the new 3D TrueVue Glass mode, and cardiac computed tomography angiography (CCTA) to assess and type the morphology of LAA. Physiological parameters were measured using traditional 2D and 3D manual (3D Manual LAA), 3D Auto LAA, and CCTA. TrueVue Glass for LAA outer contour display was compared with CCTA. Comparisons were based on correlation and consistency in measuring the maximum diameter (LZ max), minimum diameter (LZ min), area (LZ area), and circumference (LZ cir) of LAA landing zone (LZ). Times and variabilities were compared. The concordance rate for external shape of LAA was 97.14% between TrueVue Glass and CCTA. 3D Auto LAA and 3D Manual LAA have a stronger correlation and higher consistency in all parameters. 3D Auto LAA showed higher intra- and interobserver reproducibility and allowed quicker analysis (p < 0.05). LAAO was performed in 35 patients (94.59%), and none of which had serious adverse events. Conclusion: TrueVue Glass is the first non-invasive and radiation-free visualization of the overall external contour of LAA and its adjacent structures. 3D Auto LAA simplifies the measurement, making the preoperative assessment more efficient and convenient while ensuring the accuracy and reproducibility. A combination of the two is feasible for accurate and rapid assessment of LAA anatomy and physiology in AF patients and has practical application in LAAO.

Infrarenal Remains Infrarenal-EVAR Suitability of Small AAA Is Rarely Compromised despite Morphological Changes during Surveillance.

The aim was to analyze small abdominal aortic aneurysm (AAA) morphology during surveillance with regard to standard endovascular aortic repair (EVAR) suitability. This retrospective single-center study included all patients (n = 52, 48 male, 70 ± 8 years) with asymptomatic AAA ≤ 5.4 cm undergoing ≥2 computed tomography angiography(CTA)/magnetic resonance imaging (MRI) studies (interval: ≥6 months) between 2010 and 2018. Aneurysm diameter, neck quality (shape, length, angulation, thrombus/calcification), aneurysm thrombus, and distal landing zone diameters were compared between first and last CTA/MRI. Resulting treatment plan changes were determined. Neck shortening occurred in 25 AAA (mean rate: 2.0 ± 4.2 mm/year). Neck thrombus, present in 31 patients initially, increased in 16. Average AAA diameters were 47.7 ± 9.3 mm and 56.3 ± 11.6 mm on first and last CTA/MRI, mean aneurysm growth rate was 4.2 mm/year. Aneurysm thrombus was present in 46 patients primarily, increasing in 32. Neck thrombus growth and neck length change, aneurysm thrombus amount and aneurysm growth and aneurysm growth and neck angulation were significantly correlated. A total of 46 (88%) patients underwent open (12/46) or endovascular (34/46) surgery. The planned procedure changed from EVAR to fenestrated EVAR in two patients and from double to triple fenestrated EVAR in one. Thus, standard EVAR suitability was predominantly maintained as the threshold diameter for surgery was reached despite morphological changes. Consecutively, a possibly different pathogenesis of infra- versus suprarenal AAA merits further investigation.

Occluding morphologically complicated left atrial appendage using the small-umbrella LAmbre device

BackgroundPercutaneous left atrial appendage (LAA) occlusion is effective for stroke prevention in patients with atrial fibrillation. LAA can have a complex anatomy, such as multiple lobes or a large orifice, which may render it unsuitable for occlusion using regular devices. We aimed to investigate the feasibility, safety, and short-term efficacy of the small-umbrella LAmbre device for morphologically complicated LAA.MethodsWe retrospectively enrolled 129 consecutive patients who underwent LAA occlusion using the LAmbre device; the small-umbrella LAmbre device was used in 30 of these patients. We analyzed patients’ characteristics, procedural details, and outcomes.ResultsTwenty-two patients (73.3%) had multilobed (≥ 2) LAA. The umbrella of the occluder was anchored in the branch in 9 patients and in the common trunks of branches in 13 patients. The landing zone and orifice diameters were 19.0 ± 4.39 mm and 27.4 ± 3.95 mm, respectively. The sizes of the umbrella and occluder cover were 22.0 ± 3.42 mm and 34.3 ± 2.75 mm, respectively. At 3-month follow-up transesophageal echocardiography in 24 patients, no peri-device residual flow was reported. Device thrombosis was detected in one patient at 3 months and disappeared after 3 months of anticoagulation. Ischemic stroke occurred in one patient; no other adverse events were reported.ConclusionsOcclusion of morphologically complicated LAA using the small-umbrella LAmbre device was feasible, safe, and effective in patients with atrial fibrillation in this study. This occluder provides an alternative for patients who cannot be treated with regular-sized LAA occlusion devices.

A novel modular inner aortic arch stent-graft for localized Stanford type A aortic dissection aneurysm with short healthy proximal ascending aorta

A novel modular inner aortic arch stent-graft for localized Stanford type A aortic dissection aneurysm with short healthy proximal ascending aorta

Role of Intravascular Ultrasound for In Situ Sizing and Technical Assessment of Directional Branches During Branched Endovascular Aortic Repair

Role of Intravascular Ultrasound for In Situ Sizing and Technical Assessment of Directional Branches During Branched Endovascular Aortic Repair

PO-654-05 VISUALLY ESTIMATED LEFT ATRIAL APPENDAGE LANDING ZONE DIAMETER BY FLUOROSCOPY: A SIMPLE METHOD FOR WATCHMAN SIZING

PO-654-05 VISUALLY ESTIMATED LEFT ATRIAL APPENDAGE LANDING ZONE DIAMETER BY FLUOROSCOPY: A SIMPLE METHOD FOR WATCHMAN SIZING

Anatomical analysis of the aortic arch and feasibility study of double and triple branched thoracic endografts in the treatment of isolated arch pathologies.

The aim of this study was to determine the proportion of patients undergoing open arch repair who would be anatomically suitable for multi-branched endovascular arch repair. This study was a single-centre review of patients undergoing open arch repair between 2000 and 2020. Anatomical feasibility was determined by comparing arch measurements to the anatomical criteria of the Zenith® double and triple inner branched-arch endografts (Cook Medical) and the Relay® double arch branched device (Terumo-Aortic). Ninety (90) patients were included in this study, with 43/90 presenting degenerative aneurysm. The distance between the sinotubular junction and the brachiocephalic trunk measured 114 ± 30 mm on the outer curvature, and the maximum diameter of the proximal landing zone (PLZ) was 41 ± 11mm. A total of 42/90 patients (47%) were anatomically suitable for at least 1 stent graft and 29/90 patients (32%) were eligible for a triple-branched endograft. The most important determinant factors of anatomical suitability were the PLZ diameter (Cramer's V = 0.743, P < 0.001) and length (Cramer's V = 0.777, P < 0.001). This study shows that the proportion of patients who may be anatomically suitable for branched-arch repair remains limited. The PLZ dimensions tend to be the most important anatomical limitations and should receive more emphasis in the development of branched-arch devices.

Toward endovascular treatment of type A aortic dissection with smaller landing zones and more patient eligibility.

Toward endovascular treatment of type A aortic dissection with smaller landing zones and more patient eligibility.

Survival and durability after endovascular aneurysm repair reflect era-related surgical judgement

Survival and durability after endovascular aneurysm repair reflect era-related surgical judgement