One-year safety and effectiveness of the Alto abdominal stent graft in the ELEVATE IDE trial

ObjectiveThis study reports the results of a prospective, multicenter trial designed to evaluate the safety and effectiveness of the polymer based Endologix Alto Stent Graft System in treating abdominal aortic aneurysms (AAAs), with sealing 7 mm below the top of the fabric in aortic neck diameters from 16 to 30 mm.MethodsSeventy-five patients were treated with Alto devices between March 2017 and February 2018 in 16 centers in the United States for infrarenal AAAs (max diameter ≥5.0 cm in diameter or size increase by 0.5 cm in 6 months or diameter ≥1.5 times the adjacent normal aorta). Patients were followed for 30 days, 6 months, and 1 year by clinical evaluation and computed tomography and abdominal x-ray imaging. Treatment success was defined as technical success and freedom from AAA enlargement, migration, type I or III endoleak, AAA rupture or surgical conversion, stent graft stenosis, occlusion, kink, thromboembolic events, and stent fracture attributable to the device requiring secondary intervention through 12 months. Preoperative characteristics, perioperative variables, follow-up clinical evaluations, and radiographic examination results through the first 1 year were analyzed.ResultsThe mean patient age was 73 years, with 93% of patients being male. The 30-day major adverse event rate was 5.3%. At 1 year, the primary endpoint was met with a treatment success rate of 96.7%. Through 1-year post-treatment, all-cause mortality was 4.0%. No AAA-related mortality occurred. AAA enlargement was 1.6%, type I endoleak rate was 1.4%, with 100% freedom from type III endoleaks, device migration, device fracture, stent occlusion, or AAA rupture. The device-related secondary intervention rate was 2.7%.ConclusionsThis prospective study demonstrates the Endologix Alto is safe and effective in treating AAAs with appropriate anatomy at 1 year. The safety endpoint is met by a 5.3% 30-day major adverse event rate, whereas the effectiveness endpoint is met by a treatment success rate of 96%.     

Treatment Strategies for Type 2 Endoleaks after Endovascular Aneurysm Repair

Endovascular aneurysm repair (EVAR) is recognized as a minimally invasive alternative to open surgical repair of abdominal aortic aneurysms. However, endoleaks complicate nearly 20–25% of EVAR procedures. We discuss the detection and classification of endoleaks. In addition, we describe different strategies for Type 2 endoleak repair.     

腹主动脉瘤手术的麻醉

腹主动脉瘤(AAA)多发生于55岁以上男性,是一种严重的血管外科疾病。调查显示[1]男性和女性发病率分别为8.9%和2.2%,破裂后死亡率高达50%~80%,手术是惟一有效的治疗手段。由于AAA患者常合并心、脑、肾、肺等多种疾病,加之手术复杂、创伤较大,麻醉风险大,易出现各种意外。1 AAA相     

Early pyrexia after endovascular aneurysm repair: are cultures needed?

INTRODUCTION

The post-implantation syndrome after endovascular aneurysm repair (EVAR) is increasingly recognised. However, when non-vascular trainees are responsible for the care of these patients out of hours, many are investigated if pyrexial. This study assesses the role of microbiological investigations in pyrexia after endovascular aneurysm repair.

PATIENTS AND METHODS

The notes of 75 EVAR patients were reviewed retrospectively. The incidence of postoperative pyrexia and infective complications were calculated and the result of any cultures obtained.

RESULTS

Overall, 58 (77.3%) patients were pyrexial with 48 h of stent insertion. Twenty-four had blood cultures and 12 had urine cultures taken within 48 h of surgery. All of these cultures were negative. However, of those with a pyrexia after 48 h, one of nine blood cultures and two of 11 urine cultures grew organisms. Five pyrexial patients and one apyrexial patient developed a wound infection (a non-significant difference, P = 1.00).

CONCLUSIONS

Pyrexia within 48 h of EVAR is common. Microbiological investigation in the first 48 h in these patients is unrewarding. After 48 h, cultures are more likely to show growth. Although each patient must be assessed clinically for signs of sepsis, blood and urine cultures within 48 h of EVAR are generally unnecessary.     

Anaesthesia for open abdominal aortic surgery

The prevalence of abdominal aortic aneurysm (AAA) and the number of patients undergoing aneurysm repair is increasing. The UK has worked tirelessly to reduce its operative mortality rates for elective open AAA repair with the introduction of a quality improvement programme. Reducing death from ruptured aortic aneurysm has been the focus of the national screening programme. Despite the increased prevalence of disease and intervention, the popularity of open repair has diminished since the advent of endovascular repair (EVAR). The short-term benefits of EVAR when compared to open repair are well described; however, the long-term survival benefits, freedom form re-intervention and cost effectiveness of EVAR are not proven. The choice of technique for emergency AAA repair is contentious, with the more traditional approach of open repair being rapidly overtaken by endovascular options. In this article we provide an overview of the evidence supporting the different treatment options, outline current approaches to risk stratification, describe the key physiological changes that occur during open repair and describe an overview of the approach to perioperative management.     

Anaesthesia for open abdominal aortic surgery

The prevalence of abdominal aortic aneurysm (AAA) has declined in recent years and according to the annual National Vascular Registry reports (2016–20) the number of patients undergoing aneurysm repair has been steadily decreasing over the last five years. The UK has worked tirelessly to reduce its operative mortality rates for elective open AAA repair with the introduction of a quality improvement programme. Reducing death from ruptured aortic aneurysm has been the focus of the national screening programme. The short-term benefits of EVAR when compared to open repair are well described, however, the long-term survival benefits, freedom form re-intervention and cost effectiveness of EVAR have been demonstrated to be dominated by open surgery. That is that people with intact AAA should be offered open surgery if medically suitable. The choice of technique for emergency AAA repair is less contentious, with the more traditional approach of open repair being rapidly overtaken by endovascular options in those who are anatomically suitable for EVAR. Technical analysis by NICE has consistently reported favourable outcomes with EVAR in the emergency setting and that it is a cost-effective treatment. In this article we provide an overview of the evidence supporting the different treatment options, outline current approaches to risk stratification, describe the key physiological changes that occur during open repair and describe an overview of the approach to perioperative management.     

Impact of aortic wall thrombus on late changes in renal function among patients treated by fenestrated-branched endografts

Objective

Renal function deterioration is an important determinant of mortality in patients treated for complex aortic aneurysms. We have previously determined that catheter and guidewire manipulation in diseased aortas during fenestrated-branched endovascular aneurysm repair (F-BEVAR) is associated with risk of renal function deterioration. The aim of this study was to describe the impact of atherothrombotic aortic wall thrombus (AWT) on renal function deterioration among patients treated by F-BEVAR for pararenal and extent IV thoracoabdominal aortic aneurysms.

Endovascular Aneurysm Repair or Open Surgery for Treatment of Abdominal Aortic Aneurysm with Involvement of Both Common Iliac Arteries ?

Endovascular aneurysm repair (EVAR) of abdominal aortic aneurysms (AAA) involving the entire common iliac arteries requires proximal coil embolisation of both internal iliac arteries and extension of the stent graft into the external iliac arteries (type E according to the Eurostar classification). A potential complication of this treatment is pelvic ischemia. Therefore, this type of aneurysm is a relative contra-indication for EVAR.

In this case-report we describe a hybrid procedure preserving antegrade circulation in one of the internal iliac arteries in a patient with a type E aneurysm who was unfit for open surgery.     

Who should do endovascular repair of complex aortic aneurysms and how should they do them?

BackgroundCure of aneurysms which involve the aorta at the level of the visceral arteries and the thoracoabdominal segment remains a considerable surgical enterprise with a relatively high mortality and morbidity despite improvements of the surgical procedure and anesthetic technique. Fenestrated and branched endovascular stent grafts are currently available offering an attractive less invasive option especially for most frail patients. These grafts are relatively recent, technically more demanding to insert than the current stent graft for infrarenal aneurysm and besides, given the relative low frequency of the disease, they are much less used by practitioners. Thus, unconditional widespread of this sophisticated technique may not necessarily benefit patients.MethodsWe reviewed our experiences and articles regarding this concern, 1) who should perform this new technique and 2) in what kind of setting.ConclusionBased on the combined complexities of 1) patients selection, 2) proper planning and manufacturing of the graft, 3) the need for outstanding imaging and operating facilities, 4) and the required endovascular skill of physicians involved in the procedure, we feel that only highly specialized centers should be allowed to perform this complex procedure.     

Association between surgical repair of aortic aneurysms and the diagnosis of intracranial aneurysms

ObjectiveAortic aneurysms (AAs) and intracranial aneurysms (IAs) share several clinical risk factors, a genetic predisposition, and molecular signaling pathways. Nonetheless, associations between IAs and AAs remain to be thoroughly validated in large-scale studies. In addition, no effective medical therapies exist for unruptured IAs or AAs.MethodsData for this nationwide, population-based, retrospective, cohort study described herein were obtained from the National Health Insurance Research Database in Taiwan. The study outcomes assessed were (1) the cumulative incidence of IAs, which was compared between AA and patients without an AA and (2) the cumulative incidence of IAs in patients with AAs during the 13-year follow-up period, which was further compared among those who underwent open surgical repair (OSR), endovascular aneurysm repair or nonsurgical treatment (NST).ResultsOur analyses included 20,280 patients with an AA and 20,280 propensity score-matched patients without an AA. Compared with the patients without an AA, patients with AA exhibited a significantly increased risk of an IA diagnosis (adjusted hazard ratio [HR], 3.395; P < .001). Furthermore, 6308 patients with AAs were treated with surgical intervention and another 6308 propensity score-matched patients with AAs were not. Patients with an AA who underwent OSR had a significantly lower risk of being diagnosed with an IA than patients with an AA who underwent endovascular aneurysm repair or NST (adjusted HR, 0.491 [P < .001] and adjusted HR, 0.473 [P < .001], respectively).ConclusionsWe demonstrated an association between IAs and AAs, even after adjusting for several comorbidities. We also found that OSR was associated with fewer recognized IAs than NST.     

Perioperative and long-term outcomes after open conversion of endovascular aneurysm repair versus primary open aortic repair

BackgroundThe use of endovascular abdominal aortic aneurysm repair (EVAR) has superseded that of open aneurysm repair (OAR) as the procedure of choice for abdominal aortic aneurysm repair. However, significant rates of late reintervention and aneurysm rupture have been reported after EVAR, resulting in the need for conversion to OAR (C-OAR). To assess the relative effects of C-OAR on patients, we compared the outcomes of these patients to those of patients who had undergone P-OAR.MethodsThe data from all patients who had undergone C-OAR and P-OAR in the Vascular Quality Initiative Vascular Implant Surveillance and Interventional Outcomes Network database from 2003 to 2018 were queried. Multivariable logistic regression and Kaplan-Meier survival and Cox proportional hazard regression analyses were used to assess the perioperative long-term outcomes.ResultsA total of 4763 patients were included (91.4%, P-OAR; 8.6%, C-OAR). C-OAR was associated with a significant increase in the odds of perioperative mortality (odds ratio, 1.7; 95% confidence interval [CI], 1.1-2.7; P = .027) and renal complications (odds ratio, 1.5; 95% CI, 1.1-2; P = .004) vs P-OAR. At 5 years, conversion was associated with a higher risk of mortality (hazard ratio [HR], 1.5; 95% CI, 1.3-1.9; P < .001), aneurysmal rupture (HR, 1.9; 95% CI, 1.2-3.1; P = .007), and reintervention (HR, 1.4; 95% CI, 1.05-1.97; P = .022) compared with P-OAR. These results also persisted at 10 years, with conversion associated with a higher risk of mortality (HR, 1.5; 95% CI, 1.2-1.8; P < .001), rupture (HR, 1.8; 95% CI, 1.1-2.8; P = .018), and reintervention (HR, 1.5; 95% CI, 1.1-2.1; P = .010).ConclusionsThe results from the present study have demonstrated that C-OAR is associated with a significantly higher risk of perioperative morbidity and mortality compared with P-OAR. We found a significant increase in mortality, aneurysm rupture, and reintervention at 5 and 10 years of follow-up.     

Fenestrated endovascular aneurysm repair-induced acute kidney injury does not result in chronic renal dysfunction

ObjectiveAcute kidney injury (AKI) is a common physiologic complication after fenestrated endovascular aneurysm repair (FEVAR). This investigation was initiated to determine the unknown impact of post-FEVAR AKI on long-term renal function after index hospital discharge.MethodsA retrospective review was performed of an institutional FEVAR database capturing preoperative, intraoperative, and postoperative variables related to the implantation of consecutive Zenith Fenestrated endografts (ZFEN; Cook Medical, Bloomington, Ind) between October 2012 and April 2018. AKI in this study was bimodally defined as qualification by either Risk, Injury, Failure, Loss of kidney function, and End-stage (RIFLE) criteria or a postoperative serum creatinine (sCr) concentration increase of 0.5 mg/dL from baseline. Glomerular filtration rate (GFR) was calculated using the validated Modification of Diet in Renal Disease (MDRD) study equation.ResultsDuring the study period, 120 FEVARs were performed at our institution. Twenty-four (20%) patients exhibited postoperative AKI by our established definitions. Two in-hospital deaths occurred in the AKI cohort compared with none in the remaining FEVARs (P = .04). Four (16.7%) AKI patients required perioperative (<30-day) renal replacement therapy, three of whom were successfully weaned before discharge. FEVARs uncomplicated by AKI exhibited no differences in sCr concentration from baseline to 1-month, 6-month, 1-year, and 2-year follow-up (mean, 1.8 ± 1.4 years). In contrast, patients exhibiting AKI experienced an sCr concentration increase of 57.1% (P = .01) at 1 month after the procedure. This elevation decreased to 14.3% (P = .35) at 6 months after the procedure and was maintained at baseline values at 1- and 2-year office visits (follow-up, 1.3 ± 1.5 years). A similar pattern of gradual recovery during follow-up was also observed with respect to calculated GFR.ConclusionsAKI is common after FEVAR but rarely results in permanent renal dysfunction as both sCr concentration and GFR return to baseline by 6 months after the procedure.