Assessment of Thoracic Endovascular Aortic Repair Using Relay Proximal Scallop: Results of a French Prospective Multicentre Study.

OBJECTIVE: A proximal scallop design allows aortic arch repair without complex endovascular manipulation in the aortic arch. The aim was to assess the safety and efficacy at one year of the Relay proximal scallop stent graft. METHODS: A prospective multicentre study evaluated consecutive patients treated with the Relay proximal scallop stent graft in 10 French aortic centres. All consecutive patients eligible for elective thoracic endovascular repair with proximal scallop in the 10 participating centres between January 2015 and July 2018 were included. Primary endpoints were 30 day mortality, stroke, and spinal cord ischaemia (SCI) rates. Outcomes including safety and efficacy, technical and clinical success, all cause death, neurological events, vessel patency, and device specific complications were analysed. Survival and survival without severe complications were estimated using Kaplan-Meier estimates. RESULTS: Ten aortic centres treated 40 patients for thoracic aortic aneurysm (45%), penetrating atherosclerotic aneurysm (30%), and dissection (25%). Half of the procedures (50%) targeted zone 0 of the aortic arch (zone 0 in 17.5% and zones 0/1 in 32.5%), 37.5% targeted zone 2 (35% zone 2 alone; 2.5% zones 1/2), and 15% targeted zone 1 (12.5% zone 1 alone). Median follow up was one year. Thirty day mortality, stroke, and SCI rates were 10%, 5%, and 0% respectively. Primary technical success was 95%. Type Ia, Ib, and III endoleaks rates were 5.4%, 0%, and 0% respectively at one month. The overall mortality rate at one year was 17.5%. Aneurysm expansion was > 5 mm in one case at one year associated with type Ia endoleak (3%). There was no supra-aortic trunk thrombosis, one (2%) graft kink, and no migration. CONCLUSION: One year outcomes showed that the Relay proximal scallop stent graft is an acceptable answer to thoracic aortic disease to deal with short proximal landing zones.

The impact of completion and follow-up endoleaks on survival, reintervention, and rupture.

OBJECTIVE: Endoleaks may be seen at case completion of endovascular abdominal aortic aneurysm repair (EVAR), and the presence of an endoleak may impact outcomes. However, the clinical implications of various endoleaks seen during follow-up is not well-described. Therefore, we studied the impact of endoleaks at completion and at follow-up on mid-term outcomes. METHODS: We reviewed patients who underwent EVAR from 2003 to 2016 within the Vascular Quality Initiative-Medicare database and identified patients with endoleak at procedure completion and during follow-up, excluding those presenting with rupture. We stratified cohorts by presence of completion and follow-up endoleak subtypes. The primary outcome was 5-year survival, and secondary outcomes included 5-year freedom from reintervention and freedom from rupture. We used Kaplan-Meier estimates and log-rank tests to analyze differences in time-to-event endpoints. RESULTS: Of 21,745 patients with completion endoleak data, 5085 (23%) had an endoleak. Compared with those without endoleak, those with type I endoleaks had lower 5-year survival (69% vs 75%; P < .001), type II endoleaks had higher survival (79%; P < .001), and types III, IV, and indeterminate were not statistically different (73%, 73%, and 75%, respectively). Freedom from reintervention for types I and III endoleaks were significantly lower than no endoleak cohort (I: 76%; P < .001; III: 72%; P < .001 vs 83%), but freedom from rupture was higher for those with type II and III endoleak (95% and 97% vs 94%; P < .001). Of 14,479 patients with detailed follow-up endoleak data, 2290 (16%) had an endoleak. Compared with those without endoleak, types I and III had significantly lower 5-year survival (I: 80%; P = .002; III: 66%; P < .001 vs 84%), but there were no differences for types II (82%) and indeterminate (77%). Those with any type of follow-up endoleak had lower 5-year freedom from reintervention (I: 70%; P < .001; II: 76%; P = .006; III: 36%; P < .001; indeterminate: 60%; P = .007 vs 84%), and lower freedom from rupture (I: 92%; P < .001; II: 91%; P = .16; III: 88%; P = .01; indeterminate: 90%; P = .11 vs 94%). CONCLUSIONS: Compared with patients with no endoleak, those with type I completion endoleaks have lower 5-year survival and freedom from reintervention. Patients with types I and III follow-up endoleaks also have lower survival, and any endoleak at follow-up is associated with lower freedom from reintervention and freedom from rupture. These data highlight the importance of careful patient selection and close postoperative follow-up after EVAR, as the presence of endoleaks, specifically type I and III, over time portends worse outcomes.

Editor's Choice - A Comparison of Computed Tomography Angiography and Colour Duplex Ultrasound Surveillance Post Infrarenal Endovascular Aortic Aneurysm Repair: Financial Implications and Impact of Different International Surveillance Guidelines.

OBJECTIVE: Use of colour duplex ultrasound (CDUS) and computed tomography angiography (CTA) for infrarenal endovascular aortic aneurysm repair (EVAR) surveillance differs in internationally published guidelines. This study aimed firstly to compare CDUS detection of significant sac abnormalities with CTA. Secondly, a sensitivity analysis was conducted to compare financial estimates of the, predominantly CDUS based, local and Society of Vascular Surgery (SVS) protocols, the risk stratified European Society of Vascular Surgery (ESVS) protocol, and the CTA based National Institute of Health and Care Excellence (NICE) protocol. METHODS: Agreement between CDUS and CTA was assessed for detection of significant sac abnormalities. Surveillance protocols were extrapolated from published guidelines and applied to infrarenal EVAR patients active on local surveillance at a large, single centre. Surveillance intensity was dependent on presence of endoleak and subsequent risk of treatment failure in accordance with surveillance recommendations. Estimates for each surveillance protocol were inclusive of a range of published incidences of endoleak, contrast associated acute kidney injury (AKI), and excess hospital bed days, and estimated for a hypothetical five year surveillance period. RESULTS: The kappa coefficient between CDUS and CTA for detecting sac abnormalities was 0.68. Maximum five year surveillance cost estimates for the 289 active EVAR patients were £272 359 for SVS, £230 708 for ESVS, £643 802 for NICE, and £266 777 for local protocols, or £1 270, £1 076, £3 003, and £1 244 per patient. Differences in endoleak incidence accounted for a 1.1 to 1.4 fold increase in costs. AKI incidence accounted for a 3.3 to 6.2 fold increase in costs. CONCLUSION: A combined CTA and CDUS EVAR surveillance protocol, with CTA reserved for early seal assessment and confirmatory purposes, provides an economical approach without compromising detection of sac abnormalities. AKI, as opposed to direct imaging costs, accounted for the largest differences in surveillance cost estimates.

Dynamic CT perfusion imaging for type 2 endoleak assessment after endograft placement.

Endovascular repair of abdominal aortic aneurysm is a widely performed treatment method due to its minimal invasiveness, reduced need for intensive care unit (ICU), shorter hospitalization and lower 30-day morbidity and mortality compared to open surgery. Endoleak is the drawback of this procedure and is considered the main culprit for re-interventions due to the risk of late aneurysm sac growth and rupture. Type 2 endoleak (T2EL) is the most common type of endoleak which is also the most controversial regarding its management. The aim of this paper is to investigate the potential of dynamic contrast-enhanced CT for the assessment of T2EL after endovascular aneurysm repair using qualitative and quantitative image analysis of the aneurysmal sac.

The Society for Vascular Surgery practice guidelines on the care of patients with an abdominal aortic aneurysm

BACKGROUND: Decision-making related to the care of patients with an abdominal aortic aneurysm (AAA) is complex. Aneurysms present with varying risks of rupture, and patient-specific factors influence anticipated life expectancy, operative risk, and need to intervene. Careful attention to the choice of operative strategy along with optimal treatment of medical comorbidities is critical to achieving excellent outcomes. Moreover, appropriate postoperative surveillance is necessary to minimize subsequent aneurysm-related death or morbidity. METHODS: The committee made specific practice recommendations using the Grading of Recommendations Assessment, Development, and Evaluation system. Three systematic reviews were conducted to support this guideline. Two focused on evaluating the best modalities and optimal frequency for surveillance after endovascular aneurysm repair (EVAR). A third focused on identifying the best available evidence on the diagnosis and management of AAA. Specific areas of focus included (1) general approach to the patient, (2) treatment of the patient with an AAA, (3) anesthetic considerations and perioperative management, (4) postoperative and long-term management, and (5) cost and economic considerations. RESULTS: Along with providing guidance regarding the management of patients throughout the continuum of care, we have revised a number of prior recommendations and addressed a number of new areas of significance. New guidelines are provided for the surveillance of patients with an AAA, including recommended surveillance imaging at 12-month intervals for patients with an AAA of 4.0 to 4.9 cm in diameter. We recommend endovascular repair as the preferred method of treatment for ruptured aneurysms. Incorporating knowledge gained through the Vascular Quality Initiative and other regional quality collaboratives, we suggest that the Vascular Quality Initiative mortality risk score be used for mutual decision-making with patients considering aneurysm repair. We also suggest that elective EVAR be limited to hospitals with a documented mortality and conversion rate to open surgical repair of 2% or less and that perform at least 10 EVAR cases each year. We also suggest that elective open aneurysm repair be limited to hospitals with a documented mortality of 5% or less and that perform at least 10 open aortic operations of any type each year. To encourage the development of effective systems of care that would lead to improved outcomes for those patients undergoing emergent repair, we suggest a door-to-intervention time of <90 minutes, based on a framework of 30-30-30 minutes, for the management of the patient with a ruptured aneurysm. We recommend treatment of type I and III endoleaks as well as of type II endoleaks with aneurysm expansion but recommend continued surveillance of type II endoleaks not associated with aneurysm expansion. Whereas antibiotic prophylaxis is recommended for patients with an aortic prosthesis before any dental procedure involving the manipulation of the gingival or periapical region of teeth or perforation of the oral mucosa, antibiotic prophylaxis is not recommended before respiratory tract procedures, gastrointestinal or genitourinary procedures, and dermatologic or musculoskeletal procedures unless the potential for infection exists or the patient is immunocompromised. Increased utilization of color duplex ultrasound is suggested for postoperative surveillance after EVAR in the absence of endoleak or aneurysm expansion. CONCLUSIONS: Important new recommendations are provided for the care of patients with an AAA, including suggestions to improve mutual decision-making between the treating physician and the patients and their families as well as a number of new strategies to enhance perioperative outcomes for patients undergoing elective and emergent repair. Areas of uncertainty are highlighted that would benefit from further investigation in addition to existing limitations in diagnostic tests, pharmacologic agents, intraoperative tools, and devices

Unplanned stents in thoracic endovascular aortic repair for type B aortic dissection: A 16-year single-center report.

Background Unplanned stents in thoracic endovascular aortic repair mean additional stents implantation beyond the preoperative planning to achieve operation success. This study aimed to reveal the prevalence and consequences of unplanned stents in thoracic endovascular aortic repair for type B aortic dissection and explore the reasons, risk factors and solutions for unplanned stents. Methods Retrospectively analysis consecutive patients diagnosed as type B aortic dissection with initial tear originating distal from the left subclavian artery and underwent thoracic endovascular aortic repair from September 1998 to June 2014 in our center. Results Under the criteria, this study enrolled 322 patients, with 83 (25.8%) patients in unplanned group. The incidence rate of unplanned stents in thoracic endovascular aortic repair for type B aortic dissection in each year demonstrates as a bimodal curve. The curve showed that, 2003 and, 2004 was the first and highest peak and 2007 was the second peak. There was no difference in five-year survival rate between planned and unplanned patients (log-rank test, p = 0.994). The unplanned group had higher hospitalization expenses (142,699.08 ± 78,446.75 yuan vs. 175,238.58 ± 34,838.01 yuan; p = 0.019), longer operation time (104.50 ± 93.24 min vs. 179.08 ± 142.47 min; p < 0.001) and hospitalization time (17.07 ± 16.62 d vs. 24.00 ± 15.34 d; p = 0.001). The reasons for unplanned stents were type Ia endoleak (46 patients, 55.4%), bird beak (25 patients, 30.1%), and inappropriate shaping of stent (9 patients, 10.8%). Asymptomatic aortic dissection patients had higher incidence of unplanned stents. Short proximal neck length (2.66 ± 0.59 mm vs. 2.50 ± 0.51 mm; p = 0.016), short stent coverage length (154.62 ± 41.12 mm vs. 133.60 ± 44.33 mm; p = 0.002), and large distal stent oversize (75.44±10.77% vs. 82.68±15.80%; p <0.001) were risk factors for unplanned stents in thoracic endovascular aortic repair. Conclusion There are some special risk factors and reasons for unplanned stents in thoracic endovascular aortic repair for type B aortic dissection. Knowing these can we reduce the utilization of unplanned stents with appropriate methods.

Usefulness of triphasic CT aortic angiography in acute and surveillance: Our experience in the assessment of acute aortic dissection and endoleak.

INTRODUCTION: Computed tomography angiography (CTA) has been widely used in the diagnostic evaluation of many aortic diseases, but no standardized techniques actually exist for aortic CTA. The aim of this study was to describe the usefulness of triphasic CTA in aortic assessment in both non-traumatic emergency and surveillance conditions. METHODS: We performed non ECG-gated CTA examinations with a 64-slice CT scanner using a triphasic protocol consisting of an unenhanced acquisition, and two (early and delayed) contrastographic phases with a delay of 25-30 s and 100-120 s respectively after the injection of contrast medium. Were retrospectively selected adult patients with imaging findings of acute aortic dissection (AAD) or endoleak (EL) from November 2012 to November 2014. RESULTS: AAD was detected in 36 (67%) patients: 23 type A-AADs, and 13 type B-AADs. The presence of EL was observed in 18 (33%) patients: 1 type Ia, 5 types IIa, 2 types IIb, 1 type IIIa and 9 types IIIb. DISCUSSION: Triphasic CTA is useful to provide correct and prompt diagnosis of AAD in emergency, allowing the evaluation of type and atypical forms of AAD, and the identification of possible branch-vessel involvement and complications. During surveillance, triphasic CTA assures accurate and complete assessment of all known and unknown ELs and it is essential for first follow-up examination. CONCLUSION: Triphasic CTA represents a reliable imaging tool for aortic assessment in both non-traumatic emergency and surveillance after endovascular aneurysm repair. Modified protocol could be employed in selected patients and tailored in their known disease.

Endovascular aneurysm repair (EVAR) follow-up imaging: the assessment and treatment of common postoperative complications.

Endovascular abdominal aortic aneurysm repair (EVAR) is a well-established procedure, which has long-term mortality rates similar to that of open repair. It has the additional benefit of being less invasive, making it the favoured method of treating abdominal aortic aneurysms in elderly and high-risk patients with multiple co-morbidities. The main disadvantage of EVAR is the higher rate of re-intervention, due to device-related complications, including endoleaks, limb occlusion, stent migration, kinking, and infection. As a result lifelong surveillance is required. In order to avoid missing these complications, intricate knowledge of stent graft design, good-quality diagnostic ultrasound skills, multiplanar reformatting of CT images, and reproducible investigations are important. Most of these complications can be treated via an endovascular approach using cuff extensions, uncovered stents, coils, and liquid embolic agents. Open surgery is reserved for complex complications, where an endovascular approach is not feasible.

Assessment of a new type I endoleak repair technique using an anchoring device.

OBJECTIVE: Type I endoleaks are one of the most frequent and life-threatening complications of thoracic endovascular aortic repair. This study aimed to assess the use of suture-anchoring devices for repairing type I endoleaks. METHODS: The descending aortic aneurysm model (saccular type) was made by side-to-end anastomosis to a Dacron graft. A Matsui-Kitamura stent graft was deployed to create a proximal type I endoleak. Approximately 5 mm above the upper rim of the anastomosis, the aorta was punctured by the pistol of the suture-anchoring device with a T-shaped bar under fluoroscopy. Sutures were applied until angiography showed the absence of a type I endoleak. During the process, two pressure measurements were used to perform continuous assessments of aortic pressure and intra-aneurysm sac pressure. RESULTS: A mean ± SD of 5 ± 1 anchoring shots were used to eliminate type I endoleaks. The device performed well, and no complications were observed. The mean ± SD intrasac pressures before stent graft deployment, during endoleak maintenance, and after repair were 118 ± 5, 61 ± 4, and 26 ± 5 mm Hg, respectively. The postrepair pressure was significantly decreased (P < 0.001; Student t test). CONCLUSIONS: Despite some anatomic and clinical limitations identified during the experiments, the effectiveness of the suture-anchoring device was confirmed. Further improvement of the device will soon lead to its use as a less invasive endoleak repair procedure.

Ten-year results of endovascular abdominal aortic aneurysm repair from a large multicenter registry.

OBJECTIVE: To assess outcomes after endovascular abdominal aortic aneurysm repair (EVAR) in an integrated health care system. METHODS: Between 2000 and 2010, 1736 patients underwent EVAR at 17 centers. Demographic data, comorbidities, and outcomes of interest were collected. EVAR in patients presenting with ruptured or symptomatic aneurysms was categorized as urgent; otherwise, it was considered elective. Primary outcomes were mortality and aneurysm-related mortality (ARM). Secondary outcomes were change in aneurysm sac size, endoleak status, major adverse events, and reintervention. RESULTS: Overall, the median age was 76 years (interquartile range, 70-81 years), 86% were male, and 82% were Caucasian. Most cases (93.8%) were elective, but urgent use of EVAR increased from 4% in the first 5 years to 7.3% in the last 5 years of the study period. Mean aneurysm size was 5.8 cm. Patients were followed for an average of 3 years (range, 1-11 years); 8% were lost to follow-up. Intraoperatively, 4.5% of patients required adjunctive maneuvers for endoleak, fixation, or flow-limiting issues. The 30-day mortality rate was 1.2%, and the perioperative morbidity rate was 6.6%. Intraoperative type I and II endoleaks were uncommon (2.3% and 9.3%, respectively). Life-table analysis at 5 years demonstrated excellent overall survival (66%) and freedom from ARM (97%). Postoperative endoleak was seen in 30% of patients and was associated with an increase in sac size over time. Finally, the total reintervention rate was 15%, including 91 instances (5%) of revisional EVAR. The overall major adverse event rate was 7.9% and decreased significantly from 12.3% in the first 5 years to 5.6% in the second 5 years of the study period (P < .001). Overall ARM was worse in patients with postoperative endoleak (4.1% vs 1.8%; P < .01) or in those who underwent reintervention (7.6% vs 1.6%; P < .001). CONCLUSIONS: Results from a contemporary EVAR registry in an integrated health care system demonstrate favorable perioperative outcomes and excellent clinical efficacy. However, postoperative endoleak and the need for reintervention continue to be challenging problems for patients after EVAR.