The effect of Fiber Optic RealShape technology on the reduction of radiation during complex endovascular surgery.

OBJECTIVE: Despite the advantages that fenestrated endovascular aortic repair has over open repair, it is accompanied by the consequence of radiation exposure, which can result in long-term complications for both the patient and surgical staff. Fiber Optic RealShape (FORS) technology is a novel advancement that uses emitted light from a fiber optic wire and enables the surgeon to cannulate vessels in real time without live fluoroscopy. This technology has been implemented at select centers to study its effectiveness for cannulation of target vessels and its impact on procedural radiation. METHODS: We collected prospective data on physician-modified endograft (PMEG) cases before and after the introduction of FORS technology. FORS PMEGs were matched with up to three conventional fluoroscopy cases by number of target vessels, inclusion of a bifurcated device below, aneurysm extent, and patient body mass index. The procedural radiation parameters were compared between these cohorts. Within the FORS cohort, we analyzed the rate of successful target vessel cannulation for all cases done with this technology (including cases other than PMEGs), and we compared the radiation between the cannulations using only FORS with those that abandoned FORS for conventional fluoroscopy. RESULTS: Nineteen FORS PMEGs were able to be matched to 45 conventional fluoroscopy cases. Procedures that used FORS technology had significantly reduced total air kerma (527 mGy vs 964 mGy), dose area product (121 Gy∗cm2 vs 186 Gy∗cm2), fluoroscopy dose (72.1 Gy∗cm2 vs 132.5 Gy∗cm2), and fluoroscopy time (45 minutes vs 72 minutes). There was no difference in procedure length, total contrast, or digital subtraction angiography. Within FORS cases, 66% of cannulations were completed using only FORS. Cannulations using only FORS had significant reduction of navigation air kerma (5.0 mGy vs 26.5 mGy), dose area product (1.2 Gy∗cm2 vs 5.1 Gy∗cm2), and fluoroscopy time (0.6 minutes vs 2.3 minutes) compared with cannulations abandoning FORS for conventional fluoroscopy. CONCLUSIONS: This study demonstrates the advantages of FORS for total procedural radiation as well as during individual cannulation tasks. The implementation of FORS for target vessel catheterization has the potential to decrease the total degree of radiation exposure for the patient and surgical staff during complex endovascular aortic surgeries.

Aneurysm sac shrinkage at 1 year after fenestrated-branched endovascular aortic repair of complex aortic aneurysms offers mid-term survival advantage.

OBJECTIVES: To investigate the impact of 1-year changes in aneurysm sac diameter on patient survival after fenestrated-branched endovascular aortic repair (FB-EVAR) of complex abdominal aortic aneurysms or thoracoabdominal aortic aneurysms. METHODS: We reviewed the clinical data of patients enrolled in a prospective nonrandomized study investigating FB-EVAR (2013-2022). Patients with sequential follow up computed tomography scans at baseline and 6 to 18 months after FB-EVAR were included in the analysis. Aneurysm sac diameter change was defined as the difference in maximum aortic diameter from baseline measurements obtained in centerline of flow. Patients were classified as those with sac shrinkage (≥5 mm) or failure to regress (<5 mm or expansion) according to sac diameter change. The primary end point was all-cause mortality. Secondary end points were aortic-related mortality (ARM), aortic aneurysm rupture (AAR), and aorta-related secondary intervention. RESULTS: There were 549 patients treated by FB-EVAR. Of these, 463 patients (71% male, mean age, 74 ± 8 years) with sequential computed tomography imaging were investigated. Aneurysm extent was thoracoabdominal aortic aneurysms in 328 patients (71%) and abdominal aortic aneurysms in 135 (29%). Sac shrinkage occurred in 270 patients (58%) and failure to regress in 193 patients (42%), including 19 patients (4%) with sac expansion at 1 year. Patients from both groups had similar cardiovascular risk factors, except for younger age among patients with sac shrinkage (73 ± 8 years vs 75 ± 8 years; P < .001). The median follow-up was 38 months (interquartile range, 18-51 months). The 5-year survival estimate was 69% ± 4.1% for the sac shrinkage group and 46% ± 6.2% for the failure to regress group. Survival estimates adjusted for confounders (age, chronic pulmonary obstructive disease, chronic kidney disease, congestive heart failure, and aneurysm extent) revealed a higher hazard of late mortality in patients with failure to regress (adjusted hazard ratio, 1.72; 95% confidence interval, 1.18-2.52; P = .005). The 5-year cumulative incidences of ARM (1.1% vs 3.1%; P = .30), AAR (0.6% vs 2.6%; P = .20), and aorta-related secondary intervention (17.0% ± 2.8% vs 19.0% ± 3.8%) were both comparable between the groups. CONCLUSIONS: Aneurysm sac shrinkage at 1 year is common after FB-EVAR and is associated with improved patient survival, whereas sac enlargement affects only a minority of patients. The low incidences of ARM and AAR indicate that failure to regress may serve as a surrogate marker for nonaortic-related death.

Clinical comparative analysis of 3D printing-assisted extracorporeal pre-fenestration and Castor integrated branch stent techniques in treating type B aortic dissections with inadequate proximal landing zones.

BACKGROUND: This study aims to compare the clinical effects of two distinct surgical approaches, namely 3D printing-assisted extracorporeal pre-fenestration and Castor integrated branch stent techniques, in treating patients with Stanford type B aortic dissections (TBAD) characterized by inadequate proximal landing zones. METHODS: A retrospective analysis was conducted on 84 patients with type B aortic dissection (TBAD) who underwent thoracic endovascular aortic repair (TEVAR) with left subclavian artery (LSA) reconstruction at our center from January 2022 to July 2023. Based on the different surgical approaches, the patients were divided into two groups: the group assisted by 3D printing for extracorporeal pre-fenestration (n = 44) and the group using the castor integrated branch stent (n = 40). Clinical indicators: including general patient information, operative time, surgical success rate, intraoperative and postoperative complication rates, re-intervention rate, and mortality, as well as postoperative aortic remodeling, were compared between the two groups. The endpoint of this study is the post-TEVAR mortality rate in patients. RESULTS: The surgical success rate and device deployment success rate were 100% in both groups, with no statistically significant difference (P > 0.05). However, the group assisted by 3D printing for extracorporeal pre-fenestration had a significantly longer operative time (184.20 ± 54.857 min) compared to the group using the castor integrated branch stent (152.75 ± 33.068 min), with a statistically significant difference (t = 3.215, p = 0.002, P < 0.05). Moreover, the incidence of postoperative cerebral infarction and beak sign was significantly lower in the group assisted by 3D printing for extracorporeal pre-fenestration compared to the castor-integrated branch stent group, demonstrating statistical significance. There were no significant differences between the two groups in terms of other postoperative complication rates and aortic remodeling (P > 0.05). Notably, computed tomography angiography images revealed the expansion of the vascular true lumen and the reduction of the false lumen at three specified levels of the thoracic aorta. The follow-up duration did not show any statistically significant difference between the two groups (10.59 ± 4.52 vs. 9.08 ± 4.35 months, t = 1.561, p = 0.122 > 0.05). Throughout the follow-up period, neither group experienced new endoleaks, spinal cord injuries, nor limb ischemia. In the castor-integrated branch stent group, one patient developed a new distal dissection, prompting further follow-up. Additionally, there was one case of mortality due to COVID-19 in each group. There were no statistically significant differences between the two groups in terms of re-intervention rate and survival rate (P > 0.05). CONCLUSION: Both 3D printing-assisted extracorporeal pre-fenestration TEVAR and castor-integrated branch stent techniques demonstrate good safety and efficacy in treating Stanford type B aortic dissection with inadequate proximal anchoring. The 3D printing-assisted extracorporeal pre-fenestration TEVAR technique has a lower incidence of postoperative cerebral infarction and beak sign, while the castor-integrated branch stent technique has advantages in operative time.

Ultrasound Surveillance is Feasible After Endovascular Aneurysm Repair.

BACKGROUND: Surveillance after endovascular aneurysm repair (EVAR) is traditionally done with computed tomography angiography (CTA) scans that exposes patient to radiation, nephrotoxic contrast media, and potentially increased risk for cancer. Ultrasound (US) is less labor intensive and expensive and might thus provide a good alternative for CTA surveillance. The aim of this study was to evaluate in real-life patient cohorts whether US is able to detect post-EVAR aneurysm-related complications similarly to CTA. METHODS: This retrospective study compared the outcome of consecutive patients who underwent EVAR for intact abdominal aortic aneurysm and were surveilled solely by CTA (CTA-only cohort, n = 168) in 2000-2010 or by combined CTA and US (CTA/US cohort, n = 300) in 2011-2016, as a standard surveillance protocol in the department of vascular surgery, Helsinki University Hospital. The CTA-only patients were imaged at 1, 3, and 12 months and annually thereafter. The CTA/US patients were imaged with CTA at 3 and 12 months, US at 6 months and annually thereafter. If there were suspicion of >5 mm aneurysm growth, CTA scan was performed. The patients were reviewed for imaging data, reinterventions, aneurysm ruptures, and death until December 2018. The 2 groups were compared for secondary rupture, aneurysm-related and cancer-related death, reintervention related to abdominal aortic aneurysm, and maximum aneurysm diameter increase ≥5 mm. The mean follow-up in the CTA-only cohort was 67 months and in CTA/US cohort 43 months. RESULTS: The 2 cohorts were alike for basic characteristics and for the mean aneurysm diameter. The total number of CT scans for detecting aneurysm was 84.1/100 patient years in the CTA-only cohort compared to 74.5/100 patient years for US/CTA cohort. Forty percent of patients under combined CTA/US surveillance received 1 or more additional CTA scans. The 2 cohorts did not differ for 1-year, 5-year and 8-year freedom from aneurysm related death, secondary sac rupture, nor the incidence of rupture preventing interventions. CONCLUSIONS: Based on the follow-up data of this real-life cohort of 468 patients, combined surveillance with US and additional CTA either per protocol or due to suspicion of aneurysm-related complications had comparable outcome with sole CTA-surveillance. Thus, US can be considered a reasonable alternative for the CTA. However, our study showed also that the need of additional CTAs due to suspicion of endoleak or aneurysm nonrelated reasons is substantial.

Local Anesthesia for Endovascular Repair of Abdominal Aortic Aneurysm Allows for Accurate Graft Deployment with Durable Results.

BACKGROUND: Local anesthesia (LA) is sparsely used in endovascular aneurysm repair (EVAR) despite short-term benefit, likely secondary to concerns over patient movement preventing accurate endograft deployment. The objective of this study is to examine the association between anesthesia type and endoleak, sac regression, reintervention, and mortality. METHODS: The Vascular Quality Initiative database was queried for all EVAR cases from 2014 to 2022. Patients were included if they underwent percutaneous elective EVAR with anatomical criteria within instructions for use of commercially approved endografts. Multivariable logistic regression with propensity score weighting was used to determine the association between anesthesia type on the risk of any endoleak noted by intraoperative completion angiogram and sac regression. Multivariable survival analysis with propensity score weighting was used to determine the association between anesthesia type and endoleak at 1 year, long-term reintervention, and mortality. RESULTS: Thirteen thousand nine hundred thirty two EVARs met inclusion criteria: 1,075 (8%) LA and 12,857 (92%) general anesthesia (GA). On completion angiogram, LA was associated with fewer rates of any endoleaks overall (16% vs. 24%, P < 0.001). On multivariable analysis with propensity score weighting, LA was associated with similar adjusted odds of any endoleak on intraoperative completion angiogram (odds ratio [OR] 0.56, 95% confidence interval [CI] 0.47-0.68) as well as combined type 1a and type 1b endoleaks (OR 0.72, 95% CI 0.47-1.09). Follow-up computed tomography imaging at 1 year was available for 4,892 patients, 377 (8%) LA and 4,515 (92%) GA. At 1 year, LA was associated with similar rate of freedom from any endoleaks compared to GA (0.66 [95% CI 0.63-0.69] vs. 0.71 [95% CI 0.70-0.72], P = 0.663) and increased rates of sac regression (50% vs. 45%, P = 0.040). On multivariable analysis with propensity score weighting, LA and GA were associated with similar adjusted odds of sac regression (OR 1.22, 95% CI 0.97-1.55). LA and GA had similar rates of endoleak at 1 year (hazard ratio [HR] 0.14, 95% CI 0.63-1.07); however, LA was associated with decreased hazards of combined type 1a and 1b endoleaks at 1 year (HR 0.87, 95% CI 0.80-0.96). LA and GA had similar adjusted long-term reintervention rate (HR 0.77, 95% CI 0.44-1.38) and long-term mortality (HR 1.100, 95% CI 079-1.25). CONCLUSIONS: LA is not associated with increased adjusted rates of any endoleak on completion angiogram or at 1-year follow-up compared to GA. LA is associated with decreased adjusted rates of type 1a and type 1b endoleak at 1 year, but similar rates of sac regression, long-term reintervention, and mortality. Concerns for accurate graft deployment should not preclude use of LA and LA should be increasingly considered when deciding on anesthetic type for standard elective EVAR.

Safety, Effectiveness and Pitfalls of Carbon Dioxide Routine Use as a Contrast Agent for Endovascular Abdominal Aortic Repair.

BACKGROUND: Despite the evidence of good performance, carbon dioxide (CO2) routine employment as a contrast agent for endovascular procedures is far from being adopted with its use currently limited to patients with renal impairment and known allergy to iodinated contrast medium (ICM). The purpose of our study is to evaluate the safety and effectiveness of CO2 guided endovascular abdominal aortic aneurysm repair (EVAR) in a standard population and to assess the rationale for a future widespread use. METHODS: We retrospectively collected data of every patient who underwent CO2 guided standard EVAR from September 2020 to May 2021 and compared them with the data of every patient who underwent EVAR using ICM from December 2019 to August 2020 in our unit. The selection of the contrast medium was not based on any preoperative factor as the contrast medium was routinely used in every patient in both periods. The primary end point of the study was the technical success rate. Secondary end points were the early and late complication rates, radiation exposure and renal function impairment. RESULTS: 49 patients underwent ICM guided EVAR and 52 patients underwent CO2 guided EVAR in our unit in the time frames specified above. The technical success rate was 100% in both groups with no accidental coverage of any target vessel. Intraoperative endoleaks were observed in 14% of ICM patients and 25% of CO2 patients. The radiation exposure was higher in the CO2 group if compared to the ICM group (311.48 vs. 159.86 median mGy/cm2 - P < 0.001). The incidence of postoperative acute kidney injury was low and similar in the 2 groups. No significant worsening over time of the renal function has been reported in both groups. CONCLUSIONS: EVAR can be safely performed under CO2 guidance without the integration of any quantity of ICM but with an increase in radiation exposure. The nephroprotective role of CO2 guided EVAR in a standard population is unclear and the same role in renal impaired patients should be validated with further studies on selected populations.

Contrast-Enhanced Ultrasound after Endovascular Aortic Repair: Supplement and Potential Substitute for CT in Early- and Long-Term Follow-Up.

BACKGROUND: Endoleaks are the most common complication after endovascular aneurysm repair (EVAR). Computed tomography angiography (CTA) is presently the golden standard for lifelong surveillance after EVAR. Several studies and meta-analyses have shown contrast-enhanced ultrasound (CEUS) to be a good alternative. The main goal of our study was to further validate the inclusion of CEUS in follow-up examination protocols for the systematic surveillance after EVAR. METHODS: A retrospective analysis of patients who had received CEUS as part of their routine surveillance after EVAR at our center was conducted. Detection rate and classification of endoleak types were compared between available postinterventional CTA/magnetic resonance angiography and follow-up CEUS examinations. Last preinterventional CTAs before EVAR served as baselines with focus on potential cofactors such as age, body mass index, maximum aortic aneurysm diameters, endoleak orientation, and distance-to-surface influencing detection rates and classification. RESULTS: In total, 101 patients were included in the analysis. Forty-four endoleaks (43.5% of cases) were detected by either initial CEUS or CTA, mostly type II (37.6% of the included patients). Initial CEUS showed an endoleak sensitivity of 91.2%, a specificity of 100%, a positive predictive value of 100%, and a negative predictive value of 84.6%. No covariate with an influence on the correct classification could be identified either for CEUS or CT. CONCLUSIONS: CEUS should be considered a valid complementary method to CTA in the lifelong surveillance after EVAR. As type II endoleaks seem to be a common early-term, sometimes spontaneously resolving complication that can potentially be missed by CTA, we suggest combined follow-up protocols including CEUS in the early on postinterventional assessment.

Predictive Parameters of Type 1A Endoleak for Elective Endovascular Aortic Repair: A Single-Center Experience.

BACKGROUND: One of the most important factors that affects the success of Endovascular Aortic Repair (EVAR) treatment is the morphology of the neck of the aneurysm. Today, EVAR can be performed even in patients who do not meet the Instruction For Use criteria with hostile neck risk factors; thanks to the developing experience and technology. Our aim in this study was to determine risk factors for Type 1a endoleaks in patients who underwent EVAR and predictive factors for Type 1a endoleaks in patients with combinations of these risk factors. METHODS: Patients who underwent elective EVAR for infrarenal abdominal aortic aneurysm in our medical center between July 2016 and January 2021 were enrolled. Of these 244 patients, 180 patients with documented preoperative and postoperative computed tomographic angiography results and a follow-up of at least 1 year were included in the study. The Mann-Whitney U test and Student's t-test were used to assess the relationship between nominal data and numerical values, and the t-test and Wilcoxon test were used to compare dependent groups. Logistic regression analysis was performed to model risk factors associated with endoleaks. RESULTS: The results showed that a neck length less than 15 mm increased the development of type 1a endoleak by 10.4 times (P < 0.001). Furthermore, a neck diameter more than 28 mm increased the development of type 1a endoleak by 21.9 times (P = 0.04). A conical neck structure (gradual neck dilation > 2 mm) increased the development of type 1a endoleaks 4.8 times (P = 0.04). The presence of calcification (> 150 Hounsfield Unit and > 2 mm) in the neck increased the risk of type 1a endoleaks fourfold (P = 0.04). Hostile neck parameters were analyzed and patients with only 1 parameter (n = 69) had a 7.2% type 1a endoleak rate, while patients with 2 parameters (n = 15) had 26.6% and patients with more than 2 parameters (n = 11) had 45.5% type 1a endoleak rate. CONCLUSIONS: Morphologic features of the neck structure of the aneurysm are among the most important parameters that affect the success of EVAR treatment. Alternative treatments should be considered in patients with more than 1 unfavorable neck parameter.

Duplex Ultrasound-Only Surveillance after Endovascular Abdominal Aortic Aneurysm Repair is Associated with Favorable Long-Term Outcomes.

BACKGROUND: Long-term data surrounding the impact of different endovascular abdominal aortic aneurysm repair (EVAR) surveillance strategies are limited. Therefore, the purpose of this study was to characterize postoperative imaging patterns, as well as to evaluate the association of duplex ultrasound surveillance after the first postoperative year with 5-year EVAR outcomes. METHODS: EVAR patients (2003-2016), who survived at least 1 year without aneurysm rupture, conversion to open repair, and reintervention in the Vascular Implant Surveillance and Interventional Outcomes Network were examined to provide all subjects ≥3 years of follow-up time. Patients were categorized into 6 cohorts after the first postoperative year: No imaging (N = 953); computed tomography (CT)/magnetic resonance imaging (MRI)-only (N = 2,976); duplex ultrasound-only (DUS; N = 1,808); combined CT/MRI + DUS with >50% being CT/MRI (N = 1,937); combined CT/MRI + DUS with >50% being DUS (N = 2,253); and mixed (CT + DUS + MRI N = 1,272). Abdominal aortic aneurysm (AAA)-related reintervention, rupture, conversion to open repair, and all-cause mortality were estimated using Kaplan-Meier analysis. Multivariable logistic regression models identified variables associated with using DUS-only imaging (versus CT/MRI only). Cox regression models compared 5-year outcomes between patients receiving DUS-only versus CT/MRI-only imaging. RESULTS: A total of 11,199 EVAR patients were examined (mean age 76 ± 7 years; female: 20%; nonelective: 10%). DUS-only imaging surveillance after the first postoperative year was more likely to occur after elective repairs, as well as among older, male patients. Smaller (<6 cm) preoperative AAA diameter and absence of documented concurrent iliac aneurysm was also associated with DUS-only follow-up. Additionally, no endoleak detection on index EVAR completion imaging, as well as a documented >5 mm decrease in AAA sac diameter at 1-year follow-up was more common with DUS-only surveillance protocols. Post-EVAR DUS-only imaging after the first postoperative year had the lowest incidence of reintervention, conversion to open repair, and rupture (as well as the composite reintervention/open conversion/rupture; log-rank P < 0.001 for all). Further, patients receiving exclusively DUS after their first postoperative year had better overall survival (log-rank P < 0.001). These outcome advantages that were associated with DUS-only surveillance compared with CT/MRI-only surveillance after EVAR persisted when controlling for baseline covariates, preoperative AAA diameter, prior aortic surgery history, sac growth, and presence of endoleak (all P < 0.01). CONCLUSIONS: EVAR patients selected for DUS-only surveillance after the first postoperative year have excellent freedom from AAA-related reintervention, conversion to open repair, rupture and all-cause mortality. These findings remained on multivariable analysis after adjusting for baseline characteristics, endoleak status and sac diameter changes within the first year. This is the first registry-based investigation to document long-term EVAR outcomes for patients entered into a DUS-only monitoring protocol which serves to corroborate the growing evidence base that DUS may be able to supplant CT surveillance in certain subgroups. A prospective randomized multicenter trial comparing DUS versus CT-based imaging after EVAR is needed to validate these findings which may serve to change current practice guidelines, as well as industry and regulatory stakeholder requirements.

Initial single-center experience using Fiber Optic RealShape guidance in complex endovascular aortic repair.

OBJECTIVE: In the present study, we have described the technical success using Fiber Optic RealShape (FORS) endovascular guidance and its effects on the overall procedural time and radiation usage during complex endovascular aortic repair (EVAR). METHODS: Fenestrated and branched EVARs performed at a single center from 2017 to 2022 were prospectively studied. FORS-guided procedures were matched retrospectively 1:3 to non-FORS-guided procedures by the incorporated target arteries and body mass index. Technical success was defined as successful target vessel cannulation using FORS for the entirety of navigation (wire insertion to exchange for a stiff wire). The predictors of technical success were evaluated via logistic regression. The procedural times and radiation doses were compared between the matched cohorts using the Wilcoxon rank sum test. RESULTS: A total of 21 FORS-guided procedures were matched to 61 non-FORS-guided procedures. A total of 95 FORS cannulations were attempted (87 for the visceral target artery and 8 for the bifurcate gate). Technical success was achieved in 81 cannulations (85%); 15 (16%) were completed without the use of live fluoroscopy. The univariate predictors of FORS technical success included <50% target artery stenosis, <50% target artery calcification, and the target vessel attempted (P < .05 for each). FORS failures were attributed to device material properties in six cases, device failure in two cases, and the wire/catheter combination in six. The use of FORS guidance was associated with shorter median procedural and fluoroscopy times and a lower dose area product and air kerma (P ≤ .0001 for each). CONCLUSIONS: The results from our initial experience with FORS during complex EVAR, including our learning curve, has shown promise, with acceptable technical success and reductions in procedural times and radiation usage.

Monoplane versus biplane fluoroscopy in patients undergoing fenestrated/branched endovascular aortic repair.

OBJECTIVE: Endovascular aortic repair (EVAR) with fenestrated (F-EVAR) or branched (B-EVAR) endografts represents an indispensable tool of modern patient care in vascular surgery. The purpose of this retrospective study was to evaluate the center's initial experience of F/B-EVAR procedures performed under biplane angiography guidance compared with a historical control group. METHODS: From January 2020 to March 2022, 80 consecutive patients underwent F/B-EVAR under general anesthesia at a single institution. As from January 2021, the deployment of complex stent grafts was performed using an alternative intraoperative imaging modality-a biplane fluoroscopy and angiography. The cohort was divided into monoplane (MPA) and biplane (BPA) groups according to the imaging modality applied. The end points were operation time, fluoroscopy time, radiation exposure, dose of contrast agent, and technical success. RESULTS: The MPA group included 59 patients (78% male; median age; 74 years; interquartile range [IQR], 66-78 years) and the BPA group 21 patients (85.7% males; median age, 75 years; IQR, 69-79 years). Operation time (median, 320 minutes; IQR, 266-376 minutes) versus (median, 275 minutes; IQR, 216-333 minutes) was significantly lower in the BPA group (P = .006). The median fluoroscopy time (median, 82 minutes; IQR, 57-110 minutes vs median, 68 minutes; IQR, 54-92 minutes), contrast agent volume applied (median, 220 mL; IQR, 179-250 mL vs median, 200 mL; IQR, 170-250 mL), and radiation dose (dose-area product, median, 413 Gy × cm2; IQR, 249-736 Gy × cm2; vs median, 542 Gy × cm2; IQR, 196-789 Gy × cm2) were similar in both groups. Technical success of 96.6% (57/59 cases) versus 100% (21/21 cases) could be achieved in MPA and BPA group, respectively. CONCLUSIONS: F/B-EVAR procedures performed under BPA guidance were associated with a significant decrease in operation time.

The optimal operative protocol to accomplish CO2-EVAR resulting from a prospective interventional multicenter study.

OBJECTIVES: Carbon dioxide (CO2) angiography for endovascular aortic repair (CO2-EVAR) is used to treat abdominal aortic aneurysms (AAAs), especially in patients with chronic kidney disease or allergy to iodinated contrast medium (ICM). However, some technical issues regarding the visualization of the lowest renal artery (LoRA) and the best quality image through angiographies performed from pigtail or introducer sheath are still unsolved. The aim of this study was to analyze different steps of CO2-EVAR to create an operative standardized protocol. METHODS: Patients undergoing CO2-EVAR were prospectively enrolled in five European centers from 2019 to 2021. CO2-EVAR was performed using an automated injector (pressure, 600 mmHg; volume, 100 cc); a small amount of ICM was injected in case of difficulty in LoRA visualization. LoRA visualization and image quality (1 = low, 2 = sufficient, 3 = good, 4 = excellent) were analyzed at different procedure steps: preoperative CO2 angiography from pigtail and femoral introducer sheath (first step), angiographies from pigtail at 0%, 50%, and 100% of proximal main body deployment (second step), contralateral hypogastric artery (CHA) visualization with CO2 injection from femoral introducer sheath (third step), and completion angiogram from pigtail and femoral introducer sheath (fourth step). Intraoperative and postoperative CO2-related adverse events were also evaluated. χ2 and Wilcoxon tests were used for statistical analysis. RESULTS: In the considered period, 65 patients undergoing CO2-EVAR were enrolled (55/65 [84.5%] male; median age, 75 years [interquartile range (IQR), 11.5 years]). The median ICM injected was 17 cc (IQR, 51 cc); 19 (29.2%) of 65 procedures were performed with 0 cc ICM. Fifty-five (84.2%) of 65 patients underwent general anesthesia. In the first step, median image quality was significantly higher with CO2 injected from femoral introducer (pigtail, 2 [IQR, 3] vs introducer, 3 [IQR, 3]; P = .008). In the second step, LoRA was more frequently detected at 50% (93% vs 73.2%; P = .002) and 100% (94.1% vs 78.4%; P = .01) of proximal main body deployment compared with first angiography from pigtail; similarly, image quality was significantly higher at 50% (3 [IQR, 3] vs 2 [IQR, 3]; P ≤ .001) and 100% (4 [IQR, 3] vs 2 [IQR, 3]; P = .001) of proximal main body deployment. CHA was detected in 93% cases (third step). The mean image quality was significantly higher when final angiogram (fourth step) was performed from introducer (pigtail, 2.6 ± 1.1 vs introducer, 3.1 ± 0.9; P ≤ .001). The intraoperative (7.7%) and postoperative (12.5%) adverse events (pain, vomiting, diarrhea) were all transient and clinically mild. CONCLUSIONS: Preimplant CO2 angiography should be performed from femoral introducer sheath. Gas flow impediment created by proximal main body deployment can improve image quality and LoRA visualization with CO2. CHA can be satisfactorily visualized with CO2 alone. Completion CO2 angiogram should be performed from femoral introducer sheath. This operative protocol allows performance of CO2-EVAR with 0 cc or minimal ICM, with a low rate of mild temporary complications.

Inner branched complex aortic repair outcomes from a national multicenter registry using the E-xtra design platform.

BACKGROUND: Complex aortic pathology still represents an open issue in contemporary endovascular management, with continuous technological advancement being introduced in practice over time aiming to improve outcomes. Thus far, the dualism between the fenestrated and branched configuration for visceral artery revascularization is yet unsolved, with each approach having its own pros and cons. The inner branched technology for endovascular aneurysm repair (iBEVAR) aims to take the best out of both strategies, offering wide applicability and stable bridging stent sealing. The objective of this study was to evaluate the early outcomes obtained with a single manufacturer custom-made inner-branched endograft in a multicenter Italian experience. METHODS: All patients consecutively treated with E-xtra design devices in three Italian facilities were enrolled. Anatomic characteristics and perioperative data were analyzed. The main objective was to asses technical and clinical success after iBEVAR. Secondary end points were overall survival, aortic-related mortality, target visceral vessel (TVV) patency, and freedom from target vessel instability during follow-up. RESULTS: From 2016 to 2021, 45 patients were treated with an E-xtra design device revascularizing at least one visceral vessel through an inner branch. The mean age at the time of the procedure was 71.1 ± 9.3 years and 77.8% were males. The total number of target visceral arteries to be bridged with an inner branch was 159. The extent of aortic repair was thoracoabdominal in 91.1% of the cases. Technical success was achieved in 93.3% of the procedures (42/45) with all failures owing to a type I endoleak at final angiography. Each TVV was successfully connected to the graft's main body as planned without complications. Following their intervention, five patients developed spinal cord ischemia and in three of these cases symptoms persisted after discharge (6.7%). At 30 days clinical success was 93.3% (42/45). No death as well as no TVV thrombosis occurred within 30 days from the primary procedures. The mean follow-up was 22.8 ± 14.2 months. The Kaplan-Meier estimate of overall survival and TVV patency at 36 months were 83.9% and 95.9%, respectively. CONCLUSIONS: Inner branches seem to be a promising technology in the complex aortic repair landscape, with an applicability ranging from type II thoracoabdominal aneurysm to type I endoleak repair after infrarenal endografting. Whether iBEVAR could offer results comparable with those provided by fenestrated/branched endovascular aneurysm repair in terms of target vessel patency and stent stability is yet to be established and further studies are, therefore, needed.

Novel repair of acute Stanford type B aortic dissection using combined endovascular graft and transfemoral replacement of vascular plug.

We present successful treatment of dissected thoracoabdominal aorta using combined thoracic endovascular aortic repair and transfemoral replacement of Amplatzer™ vascular plug in a 38-year-old patient. Computed tomography angiography revealed a false lumen from the left subclavian artery to the left common iliac trunk, with re-entries connecting it to the true lumen of the aorta. We replaced the prosthetic endovascular graft just below the left subclavian artery to the top of the superior mesenteric artery. Amplatzer™ vascular plug was replaced below the diaphragm in a closed transfemoral procedure to prevent re-entry. The patient was discharged in good condition and 2 years postoperation imaging showed complete pseudoaneurysm closure.

Association between aortic peak wall stress and rupture index with abdominal aortic aneurysm-related events.

OBJECTIVE: The aim of this study was to assess whether aortic peak wall stress (PWS) and peak wall rupture index (PWRI) were associated with the risk of abdominal aortic aneurysm (AAA) rupture or repair (defined as AAA events) among participants with small AAAs. METHODS: PWS and PWRI were estimated from computed tomography angiography (CTA) scans of 210 participants with small AAAs (≥ 30 and ≤ 50 mm) prospectively recruited between 2002 and 2016 from two existing databases. Participants were followed for a median of 2.0 (inter-quartile range 1.9, 2.8) years to record the incidence of AAA events. The associations between PWS and PWRI with AAA events were assessed using Cox proportional hazard analyses. The ability of PWS and PWRI to reclassify the risk of AAA events compared to the initial AAA diameter was examined using net reclassification index (NRI) and classification and regression tree (CART) analysis. RESULTS: After adjusting for other risk factors, one standard deviation increase in PWS (hazard ratio, HR, 1.56, 95% confidence intervals, CI 1.19, 2.06; p = 0.001) and PWRI (HR 1.74, 95% CI 1.29, 2.34; p < 0.001) were associated with significantly higher risks of AAA events. In the CART analysis, PWRI was identified as the best single predictor of AAA events at a cut-off value of > 0.562. PWRI, but not PWS, significantly improved the classification of risk of AAA events compared to the initial AAA diameter alone. CONCLUSION: PWS and PWRI predicted the risk of AAA events but only PWRI significantly improved the risk stratification compared to aortic diameter alone. KEY POINTS: • Aortic diameter is an imperfect measure of abdominal aortic aneurysm (AAA) rupture risk. • This observational study of 210 participants found that peak wall stress (PWS) and peak wall rupture index (PWRI) predicted the risk of aortic rupture or AAA repair. • PWRI, but not PWS, significantly improved the risk stratification for AAA events compared to aortic diameter alone.

Dynamic, Time-Resolved CT Angiography After EVAR: A Quantitative Approach to Accurately Characterize Aortic Endoleak Type and Identify Inflow Vessels.

PURPOSE: Our purpose was to study the accuracy of dynamic computed tomography angiography (d-CTA) in characterizing endoleak type, inflow vessels as compared with digital subtraction angiography (DSA) using qualitative and quantitative analysis. METHODS: Between March 2019 and January 2021, all patients who underwent d-CTA imaging after EVAR were retrospectively reviewed. Two blinded independent reviewers qualitatively reviewed d-CTA and DSA images. Quantitative region of interest (ROI) analysis was performed by measuring time-resolved contrast enhancement within the aorta and endoleak lesion(s) in the aneurysm sac. Differences between time-to-peak enhancement (Δ TTP) across different ROIs were quantified. RESULTS: A total of 48 patients underwent d-CTA during the study period, of whom 24 patients had abdominal EVAR and DSA imaging for comparison. Qualitative review of DSA imaging showed type I (n=4), type II (n=16), and type III (n=2) and no endoleak (n=2). In 23 of 24 patients (95.8%), d-CTA findings correlated with DSA findings for endoleak type. One patient had a type III endoleak that was demonstrated only in d-CTA (arising from defect in polymer sealing ring of Ovation stent graft) imaging. In type II endoleak cases, d-CTA identified more inflow vessels than DSA imaging (33 vs 21 vessels, p=0.010). Quantitative analysis showed mean (±SD) Δ TTP values for type I endoleak as 1.8 (±1.8) seconds, type II as 9.6 (±3.5) seconds, and for type III endoleak as 5.6 (±1.3) seconds. CONCLUSION: Dynamic CTA can accurately characterize aortic endoleak type, inflow vessels as compared with DSA imaging. Quantitative parameters such as Δ TTP enhancement can help better differentiate endoleak types and provide an objective approach to endoleak diagnosis.

Detection of Endoleaks Following Thoracic and Abdominal Aortic Endovascular Aortic Repair-: A Comparison of Standard and Dynamic 4D-Computed Tomography Angiography.

PURPOSE: Endoleaks are a common complication after endovascular aortic repair (EVAR) and thoracic endovascular aortic repair (TEVAR). The detection and correct classification of endoleaks is essential for the further treatment of affected patients. However, standard computed tomography angiography (CTA) provides no hemodynamic information on endoleaks, which can result in misclassification in complex cases. The aim of this study was to compare standard CTA (sCTA) with dynamic, dual-energy CTA (dCTA) for detection and classification of endoleaks following EVAR or TEVAR. MATERIALS AND METHODS: This retrospective evaluation compared 69 sCTA diagnostic examinations performed on 50 different patients with 89 dCTA diagnostic examinations performed on 69 different patients. RESULTS: In total, 15.9% of sCTA examinations and 49.4% of dCTA examinations led to the detection of endoleaks. With sCTA, 20.0% of patients were diagnosed with endoleaks, while with dCTA, 37.7% of patients were diagnosed with endoleaks. With sCTA, mainly Type 1 endoleaks were detected, whereas, with dCTA, the types of detected endoleaks were more evenly distributed. In comparison with the literature, the frequencies of endoleak types detected with dCTA better reflect the natural distribution than the frequencies detected with standard CTA. CONCLUSION: Based on the retrospective comparative evaluation, dCTA could pose a valuable supplementary diagnostic tool resulting in a more accurate and realistic detection and classification of suspected endoleaks.

Long-term Results of Angulated Versus Hyperangulated Neck in Endovascular Aneurysm Repair With Endurant Endoprosthesis.

PURPOSE: Patients with a hyperangulated (>60°) proximal aortic neck and at high risk of open surgery have been treated with endovascular aortic repair (EVAR). However, long-term outcomes are not well reported. The aim of this study is to compare the technical and clinical success of EVAR in angulated (45°-60°) and hyperangulated (>60°) proximal neck angulation. MATERIALS AND METHODS: The data of all consecutive patients undergoing EVAR treated between November 2007 and February 2020 were collected. A retrospective analysis of this prospective database was performed. The primary measure outcome was technical and clinical success. In addition, we evaluated sack evolution, type IA endoleak, secondary procedures, aneurysm rupture, mortality, aneurysm-related mortality, and migration. RESULTS: In all, 246 of 1353 EVAR patients presented with an angulation of the proximal neck >45°, 130 patients presented with an infrarenal angulation >60°, while 116 patients had an angulation between 45° and 60°. Patients with a hyperangulated infrarenal aortic neck were significantly more often women (8.6% vs 26.9%), older (73.9 vs 76.7 years), and had less often diabetes mellitus (20.7% vs 10.8%). Suprarenal neck angulation and reversed tapered neck were significantly more frequent in the hyperangulated group so that propensity scores were generated using these anatomical parameters to create a matched cohort group. No significant differences in technical (87.9% vs 94.8%) and clinical success (66.4% vs 69.8%) were observed. After a mean clinical follow-up of 58.9 months significantly more secondary procedures were performed in the hyperangulated group (23.3% vs 12.9% p=0.04); however, neck-related secondary procedures were comparable (1.7% vs 6.0%; p=0.09). Also, all-cause and aneurysm-related mortality, sack evolution, type IA endoleak, aneurysm rupture, and migration were comparable for both groups. CONCLUSION: Compared with less angulated proximal aortic neck, hyperangulated neck anatomy did not reduce the technical and clinical success of EVAR but increased the risk of secondary procedures. In patients who are not good candidates for open surgery, EVAR is a reasonable alternative.

Management of an Isolated Left Vertebral Artery on the Arch During Zone 2 Landing Thoracic Endovascular Aortic Repair: A Multicentre Retrospective Study.

OBJECTIVE: To compare the early and midterm outcomes of three different strategies for an isolated left vertebral artery on the arch (LVoA) revascularisation during thoracic endovascular aortic repair (TEVAR) with a proximal zone 2 landing. METHODS: Between January 2016 and December 2021, 67 patients with LVoA and aortic arch pathologies who underwent zone 2 landing TEVAR at four medical centres were enrolled. These patients were divided into three groups for comparison: the novel chimney (group A, n = 28) with the right brachial-left brachial through and through (RLT) procedure; in vitro fenestration (group B, n = 24); and transposition (group C, n = 15). The flow direction and velocity of the LVoA was examined by Doppler ultrasound in the pre-, intra-, and post-operative periods. Primary outcomes were all cause mortality and new neurological symptoms. RESULTS: No deaths or new neurological symptoms occurred within 30 days. Early type Ia endoleak rates were 18% (n = 5), 17% (n = 4), and 0% in groups A, B, and C, respectively (p = .22). All patients had antegrade flow of the LVoA. The mean ± standard deviation duration of follow up was 63.6 ± 4.0 months. No deaths were observed during follow up. The rates of new neurological symptoms were 0%, 8%, and 33% in groups A, B, and C, respectively. The rates of midterm type Ia endoleak were 7%, 12%, and 0% in groups A, B, and C, respectively (p = .35). Bidirectional flow rates in the LVoA were 0%, 21%, and 27% in groups A, B, and C, respectively (p = .021). Two (8%) and three (20%) patients in groups B and C underwent a secondary procedure because of mild dizziness, but this was not necessary in group A (p = .058). CONCLUSION: The novel chimney technique of the RLT procedure may be feasible for patients with a LVoA requiring zone 2 anchoring. Accurate determination of the safety and feasibility of this novel technique requires larger sample sizes and longer follow up.

Custom Made Candy Plug for Distal False Lumen Occlusion in Aortic Dissection: International Experience.

OBJECTIVE: To evaluate early and midterm outcomes of the Candy Plug (CP) technique for distal false lumen (FL) occlusion in thoracic endovascular aortic repair for aortic dissection (AD) in a more real world cohort of patients from an international multicentre registry. METHODS: A multicentre retrospective study was conducted of all consecutive patients from the contributing centres with subacute and chronic AD treated with the CP technique from October 2013 to April 2020 at 18 centres. RESULTS: A custom made CP was used in 155 patients (92 males, mean age 62 ± 11 years). Fourteen (9%) presented with ruptured false lumen aneurysms. Technical success was achieved in all patients (100%). Clinical success was achieved in 138 patients (89%). The median hospital stay was 7 days (1 - 77). The 30 day mortality rate was 3% (n = 5). Stroke occurred in four patients (3%). Spinal cord ischaemia occurred in three patients (2%). The 30 day computed tomography angiogram (CTA) confirmed successful CP placement at the intended level in all patients. Early complete FL occlusion was achieved in 120 patients (77%). Early (30 day) CP related re-intervention was required in four patients (3%). The early (30 day) stent graft related re-intervention rate was 8% (n = 12). Follow up CTA was available in 142 patients (92%), with a median follow up of 23 months (6 - 87). Aneurysmal regression was achieved in 68 of 142 patients (47%); the aneurysm diameter remained stable in 69 of 142 patients (49%) and increased in five of 142 patients (4%). A higher rate of early FL occlusion was detected in the largest volume centre patients (50 [88%] vs. 70 [71%] from other centres; p = .019). No other differences in outcome were identified regarding volume of cases or learning curve. CONCLUSION: This international CP technique experience confirmed its feasibility and low mortality and morbidity rates. Aortic remodelling and false lumen thrombosis rates were high and support the concept of distal FL occlusion in AD using the CP technique.