Endoleak Rate Research Articles

Five-Year Results for Abdominal Aortic Aneurysm Repair with the GORE® EXCLUDER® Device: Insights from the Gore Global Registry for Endovascular Aortic Treatment (GREAT)

ObjectivesThe early postoperative benefits of EVAR have been well established but questions remain regarding its durability at mid and long-term timepoints. Long-term results in real-world use of EVAR outside of randomized trial data are limited. This study utilized the GREAT Registry to explore the 5-year outcomes with the GORE® EXCLUDER® device in real-world clinical circumstances. MethodsAll patients within the GREAT registry that underwent an infrarenal AAA repair with the GORE® EXCLUDER® device were included in this study. Baseline characteristics and demographic information of the cohort were collected. Endpoints included mortality (all-cause and aneurysm related), serious endoleaks, aneurysm sac diameter, endograft integrity (fracture, compression, migration), post-EVAR aortic rupture, device-related reintervention, conversion to open repair, graft explantation, and major adverse cardiovascular events (MACE). ResultsA total of 3216 patients were included in this analysis. The cohort reflected a significantly comorbid population with 46% of patients reaching a Charlson comorbidity index score of ≥ 5. Follow-up at 5 years was 60% of eligible participants. The freedom from aortic-related mortality was at 98.8% and overall survival was 71.2%. Post-operative MACE occurred in 49 (1.5%) patients. Device-related intervention through 5 years was 7.2% and the overall serious endoleak rate was 6.8%. Less than 1% of patients required an open conversion/revision and aortic rupture following device placement occurred in 15 (0.5%) patients. Aneurysm sac regression was achieved in 58.1% of patients at 5 years, and stability/absence of growth was observed in 83.6% at 5 years. ConclusionsThis study supports the durability of the GORE® EXCLUDER® device though 5 years with negligible incidence of graft integrity compromise and low aortic/device-related reintervention rates. Furthermore, the efficacy of the device is highlighted with low aortic-related mortality and high sac regression/stability diameter though 5 years.

Endurant Stent Graft for Treatment of Abdominal Aortic Aneurysm Inside and Outside of the Instructions for Use for the Proximal Neck: A 14-Year, Single-Center Experience.

Aim: To assess the medium and long-term performance of the Endurant stent graft in a cohort of consecutive patients treated with this device for an abdominal aortic aneurysm (AAA) both inside and outside of the instructions for use (IFU) and to find factors influencing the outcomes. Methods: Our observational, retrospective, single-center study included all patients who consecutively underwent endovascular aneurysm repair with the Endurant stent graft from February 2009 to January 2023. Patients with an AAA to treat according to current guidelines were included. Patients were divided into two groups: Group 1 inside of the IFUs and Group 2 outside of the IFUs for the proximal aortic neck. Patients were followed up after the procedure with computed angiography tomography, ultrasound examination, and interviews. Aneurysm-related mortality, procedure-related reinterventions, and type IA and III endoleaks were considered primary endpoints. Secondary endpoints included aneurysmal sac variations and graft thrombosis. Results: A total of 795 patients were included, 650 in Group 1 and 145 in Group 2; 732 were males, and the mean age was 74 ± 8. Anamnestic baseline did not differ between the two groups. Neck length, width, and angulation were different between the two groups (all p < 0.001). A total of 40 patients had a ruptured AAA, while 56 were symptomatic. At a mean follow-up of 43 ± 39 months, aneurysm-related mortality was less than 1%, and 82 endoleak (10.5%) were observed. Overall endoleak rate and type 1A endoleak, as well as procedure-related reintervention, were significantly more frequent in Group 2. Sac regression of at least 5 mm was observed in 65.9% of cases. AAAs larger than 60.5 mm carried a higher risk of endoleak (HR: 1.025; 95% CI: 1.013-1.37; p < 0.001) and proximal necks shorter than 13.5 mm carried a higher type 1A risk (HR: 0.890; 95% CI: 0.836-0.948; p < 0.001). Patients without chronic obstructive pulmonary disease and taking lipid-lowering drugs had an overall more consistent sac-shrinking rate. Conclusions: The Endurant stent graft proves safe and reliable. Out-of-IFU treatment has poorer medium and long-term outcomes. Some conditions influence medium and long-term reintervention risk and sac behavior. Patients with bigger aneurysms, proximal necks shorter than 13.5 mm, and chronic obstructive pulmonary disease should be more carefully evaluated during follow-up. Consistent follow-up is in keeping low aneurysm-related mortality. Personalized risk profiles and peri and postoperative management strategies are needed.

Effectiveness and Safety of Endoanchors in Abdominal and Thoracic Endovascular Aneurysm Repair: A Systematic Review and Meta-analysis

Purpose: This systematic review aimed to summarize the effectiveness and safety of endoanchor, a stabilizing device for the proximal endograft designed to prevent endoleak and stent migration in endovascular aneurysm repair (EVAR) and thoracic endovascular aneurysm repair (TEVAR). Materials and methods: A systematic review and meta-analysis was conducted per the Preferred Reporting Items for Systematic Reviews and Meta-Analysis (PRISMA) guideline. Literature up to May 31, 2023 was searched and independently screened from 4 databases. Data were pooled for meta-analysis. Primary outcomes included intraoperative and follow-up endoleak, stent migration, and reintervention rates; sac regression; and 30-day all-cause mortality. Results: Sixteen EVAR (n=1145) and 6 TEVAR studies (n=163) using the Heli-Fx EndoAnchor system were included from 2225 retrieved records. For EVAR patients (mean follow-up=11.9 months), the endoleak, graft migration, and reintervention rates were 3.97% (95% confidence interval [CI]=0.36%-1.99%), 0.004% (95% CI=0.00%-0.76%), and 5.43% (95% CI=0.86%-12.54%), respectively. The endoleak rates for primary and revision EVAR were 0.16% (95% CI=0.00%-1.65%) and 3.60% (95% CI=0.14%-9.72%), respectively. Only 4 cases of 30-day mortality (n=4) were reported in the literature. For TEVAR patients, the endoleak, stent migration, and reintervention rates were 7.4% (95% CI=0.03%-0.13%), 0.2% (95% CI=0.00%-0.06%), and 17.1% (95% CI=0.01%-0.45%), respectively. The 30-day mortality was 0.9% (95% CI=0%-0.12%). Conclusions: Endoanchor fixation in EVAR and TEVAR is effective and safe in preventing and treating endoleak and stent migration. The mortality is minimal in EVAR but higher in TEVAR. Clinical Impact Endoleak, graft migration, and reintervention in EVAR and TEVAR with endoanchor use were rare. Mortality in EVAR was low. The adjunctive deployment of endoanchors is an effective and safe means to prevent and treat endoleak and stent migration in EVAR and TEVAR. Yet, long-term efficacy and safety data and randomized controlled trials would be required to definitively recommend endoanchor use in routine clinical practice.

Clinical Outcomes and Quality of Life Following TEVAR with or without Revascularization of the Left Subclavian Artery

Objectives: This study aims to evaluate the clinical outcomes and quality of life of patients with or without the left subclavian artery (LSA) revascularization in patients with thoracic aortic diseases undergoing endovascular repair of the ishimaru zone 2. Methods: A total of 48 patients with the closure of the LSA after thoracic endovascular aortic repair (TEVAR) were enrolled in the study between 2014 and 2018, of whom 21 had undergone the LSA (revascularization group), and the remaining 27 cases (non-revascularization group). The study was planned as a single-center retrospective design. Data were retrieved from the patients’ files. Short form-36 scales were administered to assess quality of life. Results: There was no difference between the two groups with and without LSA revascularization in 30-day paraplegia (4.8% vs. 0.0%, p=0.449), 4-year cerebrovascular events (0.0% vs. 3.8%, p=0.998), upper extremity ischemia (9.6% vs. 0.0%, p=0.207), death (28.6% vs. 25.9%, p=0.887), rate of endoleak (23.8% vs. 29.6%, p=0.896), and length of intensive care unit stay (2.3±2.1 days vs. 2.1±1.8 days, p=0.645). Regarding the quality of life, only physical functioning was improved slightly more in the group that underwent LSA without revascularization (90.7±26.7 vs. 82.3±14.9, p=0.032). Conclusion: The current study showed no significant differences with respect to neurological outcomes, upper extremity ischemia, quality of life, and mortality among patients undergoing TEVAR with or without revascularization of the LSA.

Early outcomes of fenestrated and/or branched endovascular repair of complex aortic aneurysms (F/B-EVAR); A single-center experience

Background: Open surgical repair of juxta-, para- and thoracoabdominal aortic aneurysms (TAAA) has been the gold-standard for patients fit for surgery. However, endovascular repair of complex aortic aneurysms using devices implementing directional branches or fenestrations for incorporation of reno-visceral target vessels (TV) has gained widespread attention, due to its lower mortality and complication rate and its more attractive profile for high-risk patients. Nonetheless, complex endovascular technologies require meticulous abidance to protocols for successful application. Methods: A retrospective analysis of prospectively collected data from a single, tertiary center was undertaken, including all patients undergoing complex aortic endovascular repair with fenestrated (F-EVAR) of branched devices (B-EVAR) from a 5-year time period (2018-2023). Primary outcomes included 30-day mortality, while secondary outcomes included primary TV patency, acute kidney injury (AKI), spinal cord ischemia (SCI), myocardial infarction (MI) and stroke rates. Results: Of 74 patients (mean age: 69 ± 5.6 years-old, 98% males), 31 (42.6) and 43 (57.6%) were treated by F-EVAR and B-EVAR, respectively. Mean aneurysm diameter was 68 ± 1.8cm, with 15 (20.5%) juxtarenal AAA, 27 (35.6%) pararenal AAA, 16 (21.9%) type IV TAAA, 6 (8.2%) type III TAAA, and 10 (13.7%) type II TAAA treated. Sixteen (21.6%) patients were treated due to failed-EVAR. In total, 272 TV were successfully revascularized. Thirty-day mortality was 8.1%. Primary TV patency rate was 99.2% (270/272). Endoleak rate was 8.1% (6/74). No cases of AKI or MI were observed. One (1.3%) case of hemorrhagic stroke was observed. Three cases (4%) of SCI were observed, including one temporary paraparesis and two permanent paraplegia cases. Reintervention rate was 5.4%, including two cases of renal artery stent thrombosis revascularization procedures. Conclusions: Endovascular repair of complex aortic aneurysms is feasible, with good perioperative outcomes. Adherence to precise protocols covering every technical aspect of patient care is warranted for satisfactory outcomes.

Five-year outcomes for bell bottom, iliac branch endoprosthesis, and coil and cover approaches from the GREAT registry

ObjectiveThere are a variety of methods used today to treat common iliac aneurysms with endovascular techniques. Of these approaches, little is known about whether a particular limb strategy influences endoleak, reintervention, or aneurysm regression rates. We present 5-year data comparing endoleak, stent graft migration, fracture, aneurysm sac dynamics, and aortic rupture rates among patients treated with bell bottom limbs (BB), iliac branch endoprosthesis (IBE), and coil and cover (CC) approaches from the Global Registry for Endovascular Aortic Treatment registry. Secondary end points were all-cause mortality, stroke, reintervention, and paraplegia. MethodsSubjects from the GORE Global Registry for Endovascular Aortic Treatment were enrolled over a 5-year period from October 2017 to August 2022. We included 924 subjects in this study. Statistical data was generated on R software and limb groups were compared using the Pearson's χ2 test and the Kruskal-Wallis rank-sum test. ResultsWe found no statistical difference in endoleak rates, stent graft migration, fracture, or aortic rupture when stratified by limb strategy. There was no difference between limb approaches with regard to aneurysm sac dynamics among those with abdominal aortic aneurysms and common iliac aneurysms. Similarly, no statistical difference between limb strategies was found in all-cause mortality, stroke, paraplegia, or reintervention rates. Among patients that required an additional graft during reintervention, the highest rates were found within the IBE group 8.6%, compared with BB group 2.2% and CC group 1.3% (P = .006). ConclusionsOverall, there was no difference among limb strategies in endoleak rates, stent graft migration, aneurysm sac dynamics, aortic rupture rates, or our secondary end points. Increased rates of reintervention requiring an additional graft within the IBE group is noteworthy and must be weighed against the adverse effects of hypogastric sacrifice with the CC approach or potentially less advantageous seal zones in the BB approach. This finding suggests that all limb approaches have equivalent effectiveness in managing the aneurysmal common iliac artery; thus, the choice of limb strategy should be individualized and remain at physician discretion. Future research should include a more robust sample size to reproduce these findings.

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

ObjectiveLocal 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. MethodsThe Vascular Quality Initiative database was queried for all EVAR cases from 2014-2022. 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 lysis was used to determine the association between anesthesia type on the risk of any endoleak noted by intra-operative 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. Results13932 EVARs met inclusion criteria: 1075 (8%) LA and 12857 (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 intra-operative completion angiogram (OR 0.56, 95%CI 0.47-0.68) as well as combined type 1a and type 1b endoleaks (OR 0.72, 05%CI 0.47-1.09). Follow-up computed tomography imaging at 1 year was available for 4892 patients, 377 (8%) LA and 4515 (92%) GA. At 1 year, LA was associated 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, 05%CI 0.97-1.55). LA and GA had similar rates endoleak at 1 year (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). ConclusionLA 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 yype 1a and type1b 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.

Modified fenestrated/branched endovascular aortic repair with short bridging stent to treat complex aortic dissection.

This study aims to improve fenestrated/branched endovascular aortic repair (F/B EVAR) through fabricating physician-modified stent grafts (PMSG) with short bridging stent to treat complex aortic dissection. From November 2018 to January 2024, a total of 82 aortic dissection patients were treated by F/B EVAR combined with short bridging stents, including 19 aortic arch dissection patients and 63 thoracoabdominal aortic dissection patients. Inner or outer short bridging stents were applied to fabricate PMSG with the help of 3D-printing models intraoperatively. All patients underwent postoperative evaluation by enhanced computed tomography in follow-up. All aortic dissections were successfully repaired. In aortic arch group, the average operative time was 289.2 ± 88.8 min. The perioperative mortality rate was 5.3%. The total reintervention rate was 5.3%. The average follow-up duration of 36.2 ± 9.5 months. The total incidence of endoleak after surgery was 15.8%. In thoracoabdominal aorta group, the average operative time was 345.5 ± 112.0 min. The perioperative mortality rate was 1.6%. The total reintervention rate was 1.6%. The average follow-up duration of 32.4 ± 19.2 months. The total incidence of endoleak after surgery was 11.1%. The application of short bridging stents has shown promising results in reducing endoleak rates after F/B EVAR. 3D-printing is a feasible way to assist the precise fenestration and design of short bridging stents. However, the safety and reliability of this method need to be further validated.

Outcomes of thoracic endovascular aortic repair with physician-manufactured partial micropore stent grafts for aortic arch pathologies

ObjectiveThoracic endovascular aortic repair (TEVAR) has been used extensively in the management of thoracic aortic diseases. Numerous efforts have been made to enhance clinical outcomes through the use of stent grafts. This study aimed to investigate the effectiveness and safety of physician-manufactured partial micropore stent grafts (PSMGs) in TEVAR. MethodsBetween December 2017 and June 2022, data were collected from 56 patients who underwent TEVAR using physician-manufactured PSMGs. The evaluation encompassed technical success, perioperative and follow-up morbidity and mortality, stroke incidence, and branch artery patency. ResultsIn this investigation, 56 patients received treatment with physician-manufactured PSMGs. Of these patients, 46 were male, with a mean age of 62.1 ± 11.2 years. Aortic pathologies comprised aortic dissection (n = 31 [55.4%]), aortic aneurysms (n = 10 [17.9%]), penetrating aortic ulcer (n = 8 [14.3%]), and intramural hematoma (n = 7 [12.5%]). During a median follow-up of 18 months (interquartile range, 13-25 months), the stroke rate, supra-aortic branch patency rate, and endoleak rate were 0%, 100%, and 7.1%, respectively. There were no occurrences of all-cause mortality, stroke, or the necessity for open conversion. ConclusionsTEVAR with physician-manufactured PSMGs is a viable alternative for addressing aortic arch pathologies in proficient medical centers. The approach demonstrates favorable branch patency, a low complication rate, and minimal postoperative mortality.

Comparison of bare and nonbare stent grafts during thoracic endovascular aneurysm repair of the aortic arch

ObjectiveWe compared the outcomes of patients treated with nonbare stents (NBS) and proximal bare stents (PBS) endografts with a proximal landing zone in the aortic arch during thoracic endovascular aortic repair (TEVAR). MethodsWe conducted a retrospective cohort, observational, multicenter study that included 361 consecutive TEVAR procedures undertaken between November 2005 and December 2021. TEVAR patients with both BS and NBS Relay stent graft configurations with proximal landing in zones 1, 2, or 3 were enrolled. Preoperative anamnestic and morphological data, clinical outcomes, and aortic modifications 30 days after surgery and at the latest follow-up available were collected. The primary outcome was freedom from proximal endoleak (type IA) comparing the two configurations. Total and detailed endoleak rates, clinical and technical success, intraoperative additional maneuvers, major adverse events, and reinterventions were secondary outcomes. ResultsThe median follow-up was 4.9 (interquartile range, 2.0-8.1) years. No statistically significant difference between NBS and PBS patients concerning 30-day major adverse events, retrograde aortic dissection, disabling stroke, or late type IA endoleak (10.8% vs 7.8%; P = .597). Aneurysmal disease (P = .026), PLZ diameter of >34 mm (P = .026), aortic tortuosity index of >1.4 (P = .008), type III aortic arch (P = .068), and PLZ thrombus (P = .014) identified as risk factors by univariate Cox regression analysis. PLZ thrombus was the only type IA endoleak risk factor at multivariate Cox regression (P = .016). ConclusionsWe found no statistically significant difference in freedom from type IA endoleak, retrograde dissection, or disabling stroke observed between the NBS and the BS configuration of the Relay endograft. Proximal landing zone thrombotic apposition was a prominent risk factor for type IA endoleak after TEVAR.

Systematic review of risk factors and outcomes of post-implantation syndrome following endovascular aortic repair

ObjectivePost implantation syndrome (PIS) is an early systemic inflammatory response following endovascular aortic repair (EVAR). The response is variable in patients and the clinical significance of PIS upon outcomes is unknown. This study aims to evaluate the incidence, risk factors, and prognostic implication of PIS. MethodsSystematic literature review and analysis was performed in accordance with the Preferred Reporting Items for Systematic reviews and Meta-Analyses (PRISMA) and Cochrane guidelines of PubMed, Scopus, ClinicalTrials.gov, and the Cochrane Central Register of Controlled Trials. Eligible English-language studies regarding PIS after infrarenal EVAR were included, after removing duplicates. ResultsAfter screening, 31 studies were included. A total of 2847 patients were reviewed, with mean age of 70.7 years, of which 2012 (90.4%) were male, with a pooled mean follow-up of 26.1 months. PIS was reported in 25.3% of cases, with mean aneurysm diameter of 56.4 cm. Polytetrafluoroethylene (PTFE) grafts were utilized in 794 patients (27.9%) with polyester in 1839 (64.6%). White blood cell count, C-reactive protein, interleukin (IL)-6, IL-8, and IL-10 levels were all significantly elevated postoperatively. Thirty-day outcomes included type I endoleak rate of 0.8%, type II endoleak rate of 1.7%, reintervention rate of 0.35%, and mortality rate of 0.25%. Subgroup pooled analysis of patients with PIS (n = 309) vs No-PIS (n = 691) revealed that polyester (n = 642), rather than PTFE (n = 234) grafts, were associated with a higher rate of PIS (94.8% vs 3.7%; P = .0001), White blood cell count was higher in the PIS group both preoperatively (7.61 vs 6.76 × 109/L; P = .04) and postoperatively (15.0 vs 9.8 × 109/L; P = .0007) and IL-6 levels were higher in the PIS group postoperatively (98.6 vs 25.2 pg/mL; P = .02). Aneurysm diameter and amount of chronic or new thrombus within the aneurysm sac was not identified as a risk factor for PIS. Pooled outcomes of patients with PIS vs No-PIS demonstrated a significantly higher rate of 30-day mortality (0.6% vs 0%; P = .03) and major adverse cardiac events (5.8% vs 0.43%; P < .0001) without any differences seen in reintervention or 30-day type I or type II endoleaks. ConclusionsThis systematic review suggests that polyester grafts are strongly associated with PIS compared with PTFE. Interestingly, this report is suggestive of an association between 30-day mortality and major adverse cardiac events and PIS. Given these clinical sequelae, consideration for use of PTFE over polyester grafts to reduce the incidence of PIS may be a simple step to improve overall outcome. Further, exploration of the relationship between inflammatory mediators associated with PIS and mortality and cardiac complications may engender deeper understanding of risks, leading to eventual mitigation of harm for patients experiencing PIS.

Endovascular repair of the aortic arch.

The gold standard for the treatment of pathologies of the aortic arch remains the open surgical reconstruction of the affected segments. However, endovas-cular treatment options have emerged that eliminate the need for invasive open surgery. Several endograft devices - with fenestrations or branches for the supraaortic vessels - are currently available to address different pathologies and anatomical variations. Parallel-graft techniques andin situ fenestrations expand the treatment options for emergent cases. In this selective review of the literature of 2020 and 2021, we summarize the current chances and challenges of endovascular aortic repair. Reported mortality rates range from 0 to 13.2 %. Although technical success rates for fenestrated and branched devices are promising (98 %), stroke rates remain a relevant issue (10 and 3 % for BTEVAR and FTEVAR respectively). The reported technical success rate forin situfenestrations is also encouraging (94 %) and the stroke rates acceptable (5 %). Parallel-graft techniques are associated with high early and late endoleak rates (early 76 %; late 31 %), but still hold a valuable place in the treatment of emergent cases or in bail-out situations. The endovascular repair of the aortic arch expands the range of patients with pathologies of the arch eligible for treatment to those unfit for open surgery offering a minimally invasive, yet technically challenging procedure. More data and meta-analyses are needed to define the benefits and drawbacks of this promising treatment option in an aging population with increasing co-morbidities.

Comparison of surgical and endovascular left subclavian artery revascularization during thoracic aortic endovascular repair: a systematic review and meta-analysis.

The purpose of this systematic review and meta-analysis was to incorporate data from the latest clinical studies and compare the safety and efficacy of surgical left subclavian artery (LSA) revascularization and endovascular LSA revascularization during thoracic endovascular aortic repair (TEVAR). This study was performed in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines and was registered with the PROSPERO database on 16 April 2023 (CRD42023414579). The Embase, MEDLINE (PubMed), and the Cochrane Library databases were searched from January 2000 to May 2023. A total of 14 retrospective cohort studies with a total of 1,695 patients, were included for review. The peri-operative stroke rates of the surgical and endovascular LSA revascularization groups were 3.8% and 2.6%, respectively (P = 0.97). The peri-operative technical success rates for the surgical and endovascular LSA revascularization groups were 95.6% and 93.0%, respectively (P = 0.24). The peri-operative spinal cord ischemia rates were 1.6% (n = 18) and 1.9% (n = 7) in the surgical and endovascular LSA revascularization groups, respectively (P = 0.90). The peri-operative type Ⅰ endoleak rates for the surgical and endovascular LSA revascularization groups were 6.6% and 23.2%, respectively (P = 0.25). The subgroup analysis showed that the incidence of peri-operative type I endoleak in the parallel stent group was significantly higher than that in the surgical LSA revascularization group (P < 0.0001). The peri-operative left upper limb ischemia rates for the surgical and endovascular LSA revascularization groups were 1.2% and 0.6%, respectively (P = 0.96). The peri-operative mortality rates of the surgical and endovascular LSA revascularization groups were 2.0% and 2.0%, respectively (P = 0.88). There was no significant difference in the terms of short-term outcomes when comparing the two revascularization techniques. The quality of evidence assessed by GRADE scale was low to very-low. Surgical and endovascular LSA revascularization during TEVAR were both safe and effective. Compared with surgical LSA revascularization techniques, parallel stent revascularization of LSA significantly increased the rate of type I endoleak.

Five Year Post-Endovascular Aneurysm Repair Aneurysm Sac Evolution in the GREAT Registry: an Insight in Diabetics Using Propensity Matched Controls

To assess differences in the five year abdominal aortic aneurysm (AAA) sac regression rate after endovascular aneurysm repair (EVAR) in patients with and without diabetes mellitus (DM). An international prospective registry (Europe, USA, Brazil, Australia, and New Zealand) of patients treated with the GORE EXCLUDER endograft. All scheduled EVARs for infrarenal AAA between 2014 and 2016 with complete five year imaging follow up were included. Emergency procedures, ancillary proximal procedures, and inflammatory and infectious aetiologies were excluded. Descriptive and inferential statistics, and Cox proportional hazards survival models were used. A control group of patients without DM with similar age and comorbidities was selected using propensity scores, matched in a 1:2 scheme. A total of 2 888 patients (86.1% male; mean age 73.5 ± 8 years) was included, of whom 545 (18.9%) had DM. Patients with DM had higher rates of hypertension (89.2% vs. 78.4%), dyslipidaemia (76.0% vs. 60.7%), coronary artery disease (52.3% vs. 37.9%), and chronic renal impairment (20.9% vs. 14.0%) (all p < .001). The mean pre-procedural AAA diameter was 58.1 ± 10 mm. Five years post-EVAR, the type 1A endoleak rate was 1.1% (0.6% DM vs. 1.2% non-DM), the endograft related re-intervention rate was 7.3% (6.2% vs. 7.6%), the major adverse cardiovascular event (MACE) rate was 1.4% (1.1% vs. 1.5%), and aortic related mortality rate was 1.0% (0.6% vs. 1.2%), without statistically significant differences between groups. The overall five year mortality rate was higher in diabetics (36.3% vs. 30.5%; hazard ratio [HR] 1.30, 95% confidence interval [CI] 1.07 - 1.58; p= .001). No statistically significant differences were found in sac regression rate (≥ 5 mm) between diabetics and non-diabetics 70.0% vs. 73.1%; HR 0.88, 95% CI 0.75-1.04; p = .131. These differences remained statistically non-significant after excluding patients performed out of instructions for use (p= .61) and patients with types 1, 2 or 3 endoleaks (p= .39). The paradoxical relationship between DM and AAA does not appear to result in differences in post-EVAR sac regression rates. However, even when controlling for other comorbidities, patients with DM undergoing EVAR may have a higher five year mortality rate.

The Impact of Proximal Neck Anatomy on the 5-Year Outcomes Following Endovascular Aortic Aneurysm Repair With the Ovation Stent Graft.

Hostile proximal neck anatomy has historically been associated with worse outcomes for endovascular aortic aneurysm repair (EVAR) of abdominal aortic aneurysms (AAA). We investigated the impact of proximal neck anatomy on the outcomes following EVAR with the Ovation abdominal stent graft (Endologix, Irving, Calif). We used prospectively collected data from the Effectiveness of Custom Seal with Ovation: Review of the Evidence database, compromised of pooled data from 6 clinical trials and the European Post-Market Registry of patients undergoing elective infrarenal EVAR (2009-2017). We investigated the impact of short neck length (<10 mm), wide neck diameter (≥28 mm), reverse taper shape (>10%), and neck angulation (>45°) on the outcomes. The primary outcome was type IA endoleak. Secondary outcomes included any type I/III endoleak, sac expansion, aneurysm-related reinterventions, and all-cause and aneurysm-related mortality, and a combined endpoint of type IA endoleak, graft migration, AAA-related reintervention, conversion, and aneurysm rupture. We used Kaplan-Meier analysis and Cox proportional hazards models to estimate the 30 day and 5 year rates and assess univariate and risk-adjusted differences. Of the 1020 patients, 60 patients had a short neck, 113 had a wide neck diameter, 279 were reverse taper shaped, and 99 had neck angulation >45°. Wide proximal neck was associated with higher 5 year type IA endoleak estimates compared with favorable neck anatomy (7.1% vs 4.3%; p=0.02). No association with 5 year type IA endoleak was found for short neck length (1.7% vs 4.3%; p=0.52), reverse taper shape (3.2% vs 4.3%; p=0.99), or neck angulation (6.1% vs 4.3%; p=0.13). A wide neck diameter compared with favorable anatomy was also associated with higher 5 year estimates of graft migration (3.8% vs 0.4%; p=0.03) and the combined neck-related adverse outcome endpoint (16% vs 9.5%; p=0.002). The estimates of aneurysm sac expansion, rupture, and overall and aneurysm-related mortality were similar between the hostile proximal neck anatomy cohorts and favorable anatomy. Wide proximal neck is associated with higher 5 year type IA endoleak rates for patients treated with the Ovation stent graft. However, short neck length, reverse taper shape, and neck angulation are not associated with higher 5 year type IA endoleak rates. Hostile proximal neck anatomy has historically been associated with worse outcomes for endovascular aortic aneurysm repair of abdominal aortic aneurysms. The Ovation stent graft platform uses a different proximal sealing method using a polymer inflatable ring, aiming to improve sealing between the graft and aortic wall. This study demonstrated that short, angulated, and reverse taper-shaped neck anatomy did not result in increased type IA endoleak estimates in patients treated with the Ovation stent graft platform. Potentially, the different sealing mechanisms played a role in mitigating the historically worse outcomes in patients with short, angulated, and reverse taper-shaped neck anatomy.

3D Printing-Assisted versus Conventional Extracorporeal Fenestration Tevar for Stanford Type B Arteries Dissection with Undesirable Proximal Anchoring Zone: Efficacy Analysis

Background: To compare the outcomes of two Thoracic Endovascular Aortic Repair (TEVAR) techniques of Left Subclavian Artery (LSA) reconstruction for Stanford Type B Aortic Dissection (TBAD) patients with undesirable proximal anchoring zone. Methods: We retrospectively reviewed 57 patients with TBAD who underwent either three dimensional (3D)-printing-assisted extracorporeal fenestration (n = 32) or conventional extracorporeal fenestration (n = 25) from December 2021 to January 2023. We compared their demographic characteristics, operative time, technical success rate, complication rate, secondary intervention rate, mortality rate, and aortic remodeling. Results: Compared with the conventional group, the 3D-printing-assisted group had a significantly shorter operative time (147.84 ± 33.94 min vs. 223.40 ± 65.93 min, p &lt; 0.001), a significantly lower rate of immediate endoleak (3.1% vs. 24%, p = 0.048) and a significantly higher rate of true lumen diameter expansion in the stent-graft segment (all p &lt; 0.05), but a significantly longer stent graft modification time (37.63 ± 2.99 min vs. 28.4 ± 2.12 min, p &lt; 0.001). There were no significant differences in other outcomes between the two groups (p &gt; 0.05). The degree of false lumen thrombosis was higher in the stent-graft segment than in the non-stent-graft segment in both groups and the difference was statistically significant (X2 = 5.390, 4.878; p = 0.02, 0.027). Conclusions: Both techniques are safe and effective for TBAD with an undesirable proximal landing zone. The 3D-printing-assisted extracorporeal fenestration TEVAR technique has advantages in operative time, endoleak risk, and aortic remodeling, while the traditional extracorporeal fenestration TEVAR technique has advantages in stent modification.

Intra-Sac Injection of Thrombin During Endovascular Aneurysm Repair to Remedy Type II Endoleak and Promote Sac Shrinkage.

To evaluate the safety and effectiveness of intra-sac thrombin injection to remedy type II endoleaks (T2ELs) during endovascular aneurysm repair (EVAR). 224 cases abdominal aortic aneurysm (AAA) were treated with EVAR. For the 52 cases of intra-operative type II endoleaks and 8 cases of ruptured AAAs, after the grafts were deployed, thrombin was injected into the aneurysm sac through a preset catheter. The occurrence of endoleaks post-EVAR were followed up with by Computed Tomography (CT) angiogram. The diameter and the volume of the aneurysm sac were also measured. Endpoints included incidence of T2ELs, AAA sac shrinkage and re-intervention rate and all-cause mortality. The overall technical success rate was 100%. Fifty-two patients were followed up with for 9-56 (median 24) months. No serious complications were observed during follow-up. The incidence of endoleak was 5.8% (3/52) during follow-up. The maximum diameter of the aneurysm decreased from 61.1 ± 14.2mm to 53.7 ± 10.6mm, 47.9 ± 8.3mm and 43.7 ± 7.2mm (87.9%, 78.4% and 71.5% of pre-EVAR) at the 6-month, 1-year and 2-year follow-up, respectively (P < .05). The volume of the aneurysm sac shrank from 236.2 ± 136.2cm3 to 202.6 ± 114.1cm3, 155.6 ± 68.4cm3 and 129.7 ± 52.4cm3 (85.8%, 65.9%, and 54.9% of pre-EVAR) at the 6-month, 1-year and 2-year follow-up, respectively (P < .05). The rate of various endoleaks was 5.8% (3/52) and the re-intervention rate was 1.9% (1/52) in this research. Clinical outcomes show that intra-sac injection of thrombin during EVAR is safe and may be effective in remedying small amount and low-velocity endoleaks and promoting shrinkage of the aneurysm sac.

Value of contrast-enhanced ultrasonography in detection of endoleak after endovascular repair of infrarenal abdominal aortic aneurysm

Objective: To investigate the value of contrast-enhanced ultrasound in detecting endoleak after endovascular repair of infrarenal abdominal aortic aneurysm (EVAR). Methods: The postoperative follow-up data of 102 patients with infrarenal abdominal aortic aneurysm treated with EVAR in Tianjin Medical University General Hospital from August 2015 to December 2021 were retrospectively analyzed. There were 79 males and 23 females, aged 50-91 (69.6±7.6) years old. Using CT angiography (CTA) as the gold standard for diagnosing endoleaks, the effectiveness of contrast-enhanced ultrasound and CDUS in detecting endoleaks was evaluated by paired design chi-square test, and the Kappa value was calculated for consistency test. Patients were divided into groups according to body mass index (BMI), and the number of false-negative endoleaks detected by contrast-enhanced ultrasound in each group was calculated, and its ratio to the actual number of endoleaks was calculated to evaluate whether BMI was related to false-negative ultrasound-enhanced ultrasound. Results: A total of 203 follow-up visits met the inclusion criteria. Endoleaks were detected 36 times (17.7%) by CTA, 31 times (15.3%) by contrast-enhanced ultrasound, 16 times (7.9%) by CDUS, and they all detected type Ⅰ, type Ⅱ and type Ⅲ endoleaks. There was no significant difference between contrast-enhanced ultrasound and CTA in endoleak detection rate and determination of endoleak types (endoleak detection rate: 15.3% vs 17.7%; determination of endoleak types: type Ⅰ 4 vs 4, type Ⅱ 26 vs 31, type Ⅲ 1 vs 1; all P>0.05). CDUS and CTA had statistically significant differences in the detection rate of endoleaks and determination of endoleak types (endoleak detection rate: 7.9% vs 17.7%; determination of endoleak types: type Ⅰ 4 vs 4, type Ⅱ 11 vs 31, type Ⅲ 1 vs 1; all P<0.001). Compared with CTA, contrast-enhanced ultrasound has a sensitivity of 83.3%, a specificity of 99.4%, a Youden index of 0.827, a coincidence rate of 96.6%, a positive predictive value of 96.8%, a negative predictive value of 96.5%, and a Kappa value of 0.875(P<0.001). The two showed excellent diagnostic consistency. All 6 endoleaks not detected by contrast-enhanced ultrasound were type Ⅱ endoleak that did not require treatment, and 3(15.8%) occurred in obese patients with a BMI≥32 kg/m2. Compared with CTA, CDUS had a sensitivity of 38.9%, a specificity of 98.8%, a Youden index of 0.377, a coincidence rate of 88.2%, a positive predictive value of 87.5%, a negative predictive value of 88.2%, and a Kappa value of 0.482 (P<0.001). The two showed moderate diagnostic agreement. The correlation coefficient of the maximum diameter of aneurysms measured by ultrasound and CT was r=0.873(P<0.001). Conclusions: Contrast-enhanced ultrasound is accurate in detecting endoleak after infrarenal EVAR, and its sensitivity to endoleak detection in obese patients with BMI≥32 kg/m2 will be reduced. CDUS is not suitable for detection of endoleak after infrarenal EVAR, but it can be used to monitor the change of the largest diameter of aneurysm after EVAR.

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

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. 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 1year 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. The results showed that a neck length less than 15mm increased the development of type 1a endoleak by 10.4 times (P<0.001). Furthermore, a neck diameter more than 28mm increased the development of type 1a endoleak by 21.9 times (P=0.04). A conical neck structure (gradual neck dilation > 2mm) increased the development of type 1a endoleaks 4.8 times (P=0.04). The presence of calcification (> 150 Hounsfield Unit and > 2mm) 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. 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.

Possible implications of device-specific variability in post-endovascular aneurysm repair sac regression and endoleaks for surveillance categorization

ObjectiveSignificant sac regression during early surveillance has been shown to best predict reintervention-free long-term surveillance after endovascular aneurysm repair (EVAR). Furthermore, a persistent endoleak has been related to a worse outcome. Individualized surveillance algorithms based on these findings have been suggested. There are no studies comparing the performance of different stent grafts regarding sac regression, the presence of type II endoleaks, and their possible implications for individualized surveillance. The objective of this study was to evaluate device-specific differences and how these may affect patient categorization for surveillance. MethodsPatients were treated electively with standard EVAR between 2005 and 2015 using three different devices (Zenith by Cook, Excluder by Gore, and Endurant by Medtronic). The data were reviewed retrospectively until 2020. Patients’ computed tomography angiographies (CTAs) at 30 days and at 2 years were analyzed for freedom from endoleaks and for sac regression of ≥5 mm. Reinterventions during long-term surveillance were counted. Patients were categorized according to the presence of any endoleak and sac regression at 30 days and 2 years, and the probability of reintervention-free long-term surveillance was evaluated based on these findings. ResultsA total of 435 patients were treated for an abdominal aortic aneurysm with EVAR during the study period. At 30 days, 80.0% (n = 339) of the patients were free from endoleaks, and at 2 years, 78.9% (n = 273) were free from endoleaks. There was a significant difference in endoleak rate at 30 days and 2 years between the devices (P < .001 and P = .001). There was no significant difference in sac regression between the devices at 2 years (P = .096). The categorization at 30 days based on endoleak status had a sensitivity of 44.9%, specificity of 87.4%, and negative predictive value of 84.1% for finding a reintervention-requiring complication during long-term follow-up. The corresponding figures at 2 years were 63.3%, 91.4%, and 89.4%, respectively. The combination of freedom from endoleaks and sac regression of ≥5 mm in the 2-year CTA best predicted an uneventful long-term surveillance. Patients who met this criterion had a 95.6% probability (negative predictive value) of having a reintervention-free long-term surveillance. ConclusionsThere are significant differences in the prevalence of endoleaks between devices at 30 days and 2 years, but there is no difference in sac regression. Patients with sac regression of ≥5 mm and no endoleaks in the 2-year CTA can be safely categorized for infrequent surveillance regardless of the stent graft model that has initially been used.