A risk-adjusted and anatomically stratified cohort comparison study of open surgery, endovascular techniques and medical management for juxtarenal aortic aneurysms-the UK COMPlex AneurySm Study (UK-COMPASS): a study protocol.

INTRODUCTION: In one-third of all abdominal aortic aneurysms (AAAs), the aneurysm neck is short (juxtarenal) or shows other adverse anatomical features rendering operations more complex, hazardous and expensive. Surgical options include open surgical repair and endovascular aneurysm repair (EVAR) techniques including fenestrated EVAR, EVAR with adjuncts (chimneys/endoanchors) and off-label standard EVAR. The aim of the UK COMPlex AneurySm Study (UK-COMPASS) is to answer the research question identified by the National Institute for Health Research Health Technology Assessment (NIHR HTA) Programme: 'What is the clinical and cost-effectiveness of strategies for the management of juxtarenal AAA, including fenestrated endovascular repair?' METHODS AND ANALYSIS: UK-COMPASS is a cohort study comparing clinical and cost-effectiveness of different strategies used to manage complex AAAs with stratification of physiological fitness and anatomical complexity, with statistical correction for baseline risk and indication biases. There are two data streams. First, a stream of routinely collected data from Hospital Episode Statistics and National Vascular Registry (NVR). Preoperative CT scans of all patients who underwent elective AAA repair in England between 1 November 2017 and 31 October 2019 are subjected to Corelab analysis to accurately identify and include every complex aneurysm treated. Second, a site-reported data stream regarding quality of life and treatment costs from prospectively recruited patients across England. Site recruitment also includes patients with complex aneurysms larger than 55 mm diameter in whom an operation is deferred (medical management). The primary outcome measure is perioperative all-cause mortality. Follow-up will be to a median of 5 years. ETHICS AND DISSEMINATION: The study has received full regulatory approvals from a Research Ethics Committee, the Confidentiality Advisory Group and the Health Research Authority. Data sharing agreements are in place with National Health Service Digital and the NVR. Dissemination will be via NIHR HTA reporting, peer-reviewed journals and conferences. TRIAL REGISTRATION NUMBER: ISRCTN85731188.

Characterising the incidence and mode of visceral stent failure after fenestrated endovascular aneurysm repair (FEVAR).

BACKGROUND: In FEVAR, visceral stents provide continuity and maintain perfusion between the main body of the stent and the respective visceral artery. The aim of this study was to characterise the incidence and mode of visceral stent failure (type Ic endoleak, type IIIa endoleak, stenosis/kink, fracture, crush and occlusion) after FEVAR in a large cohort of patients at a high-volume centre. METHODS: A retrospective review of visceral stents placed during FEVAR over 15 years (February 2003-December 2018) was performed. Kaplan-Meier analyses of freedom from visceral stent-related complications were performed. The outcomes between graft configurations of varying complexity were compared, as were the outcomes of different stent types and different visceral vessels. RESULTS: Visceral stent complications occurred in 47/236 patients (19.9%) and 54/653 stents (8.3%). Median follow up was 3.7 years (IQR 1.7-5.3 years). There was no difference in visceral stent complication rate between renal, SMA and coeliac arteries. Visceral stent complications were more frequent in more complex grafts compared to less complex grafts. Visceral stent complications were more frequent in uncovered stents compared to covered stents. Visceral stent-related endoleaks (type Ic and type IIIa) occurred exclusively around renal artery stents. The most common modes of failure with SMA stents were kinking and fracture, whereas with coeliac artery stents it was external crush. CONCLUSION: Visceral stent complications after FEVAR are common and merit continued and close long-term surveillance. The mode of visceral stent failure varies across the vessels in which the stents are located.

Achieving High Reliability with People, Processes, and Technology.

High reliability as a corporate value in healthcare can be achieved by meeting the "Quadruple Aim" of improving population health, reducing per capita costs, enhancing the patient experience, and improving provider wellness. This drive starts with the board of trustees, CEO, and other senior leaders who ingrain high reliability throughout the organization. At WellStar Health System, the board developed an ambitious goal to become a top-decile health system in safety and quality metrics. To achieve this goal, WellStar has embarked on a journey toward high reliability and has committed to Lean management practices consistent with the Institute for Healthcare Improvement's definition of a high-reliability organization (HRO): one that is committed to the prevention of failure, early identification and mitigation of failure, and redesign of processes based on identifiable failures. In the end, a successful HRO can provide safe, effective, patient- and family-centered, timely, efficient, and equitable care through a convergence of people, processes, and technology.

Late Rupture of Abdominal Aortic Aneurysm After Previous Endovascular Repair: A Systematic Review and Meta-analysis.

PURPOSE: To report a systematic literature review of late rupture of abdominal aortic aneurysm (AAA) after endovascular aneurysm repair (EVAR) and the results of a pooled analysis of causes, treatment, and outcomes. METHODS: Electronic information sources and bibliographic reference lists were interrogated using a combination of free text and controlled vocabulary searches; 11 articles were ultimately identified that fulfilled the inclusion criteria. The articles reported a total of 190 patients who were included in the qualitative and quantitative synthesis. Mortality within 30 days or during the admission with aneurysm rupture was a primary endpoint; major perioperative morbidity was a secondary endpoint. A meta-analysis was performed for 30-day/in-hospital mortality using the random effects model. RESULTS: A total of 152 ruptures occurred after 16,974 EVAR procedures reported by 8 of the case series, giving an incidence of 0.9% [95% confidence interval (CI) 0.77 to 1.05]. The mean time to rupture was 37 months. Twenty-nine percent (95% CI 20 to 39) of the patients had at least one previous secondary endovascular intervention following the initial EVAR, and 37% (95% CI 30 to 45) were not compliant with surveillance. Type I and III endoleaks were the predominant causes of rupture. Open surgical treatment was undertaken in 61% (95% CI 53 to 68) of the patients who underwent treatment. The pooled estimate for perioperative mortality was 32% (95% CI 24 to 41). A significantly lower mortality was found with endovascular treatment than open surgical management (p=0.027). CONCLUSION: Graft-related endoleaks appear to be the predominant causes of late aneurysm rupture. Quality of and compliance with post-EVAR surveillance are important factors in late rupture; a large proportion of late ruptures are amenable to endovascular treatment.

Outcomes of persistent intraoperative type Ia endoleak after standard endovascular aneurysm repair.

OBJECTIVE: This study analyzed outcomes for patients with persistent intraoperative type Ia endoleaks after standard endovascular aneurysm repair (EVAR). METHODS: The study group was identified from a consecutive cohort of 209 patients undergoing EVAR in a tertiary center in the United Kingdom during a 2-year period. Data prospectively collected on departmental computerized databases were retrospectively analyzed. Primary outcome parameters were defined as freedom from type Ia endoleak, EVAR-related reintervention, aneurysm rupture, and aneurysm-related mortality. RESULTS: A completion angiogram identified 44 patients (21%) as having a type Ia endoleak, and 33 (75%) had a persistent endoleak after intraoperative adjunctive procedures, including repeated balloon moulding, aortic cuff extension, and Palmaz stent (Cordis, Miami Lakes, Fla) deployment. In the 11 patients (25%) whose endoleak was successfully abolished intraoperatively, there was no recurrence of type Ia endoleak or secondary intervention to treat type 1a endoleak during a median follow-up period of 27 months. Of the 33 patients with persistent endoleak, 31 (94%) demonstrated resolution of the endoleak on first surveillance computed tomography angiography. One patient was lost to follow-up. Embolization of the endoleak in another patient was successful using Onyx (Micro Therapeutics, Inc, Irvine, Calif) 8 days after the initial procedure. No type Ia endoleak was identified after this on any surveillance imaging, and the patient was alive 28 months later with a stable aneurysm size. In the rest of the patients, no recurrence of the endoleak in any subsequent imaging was noticed, and no secondary intervention was required during follow-up. No aneurysm-related deaths occurred, and 91% of the patients had a stable or shrinking aneurysm. CONCLUSIONS: Despite adjunctive intraoperative maneuvers, persistent type Ia endoleaks can be relatively common. Our study indicates that they may be observed in selected patients. Further research is required to investigate the natural course and management of type Ia endoleaks identified intraoperatively.

Meta-analysis of the effects of statins on perioperative outcomes in vascular and endovascular surgery.

BACKGROUND: Compelling evidence from large randomized trials demonstrates the salutary effects of statins on primary and secondary protection from adverse cardiovascular events in high-risk populations. Our objective was to investigate the role of perioperative statin therapy in noncardiac vascular and endovascular surgery. METHODS: Electronic information sources were systematically searched to identify studies comparing outcomes after noncardiac surgical or endovascular arterial reconstruction in patients who were and were not taking statin in the perioperative or peri-interventional period. The Cochrane Collaboration's tool and the Newcastle-Ottawa scale were used to assess the methodologic quality and risk of bias of the selected studies. Random-effects models were applied to calculate pooled outcome data. RESULTS: Four randomized controlled trials and 20 observational cohort or case-control studies were selected for analysis. The randomized studies enrolled 675 patients, and the observational studies enrolled 22,861 patients. Statin therapy was associated with a significantly lower risk of all-cause mortality (odds ratio [OR], 0.54; 95% CI, [CI], 0.38-0.78), myocardial infarction (OR, 0.62; 95% CI, 0.45-0.87), stroke (OR, 0.51; 95% CI, 0.39-0.67), and the composite of myocardial infarction, stroke, and death (OR, 0.45; 95% CI, 0.29-0.70). No significant differences in cardiovascular mortality (OR, 0.82; 95% CI, 0.41-1.63) and the incidence of kidney injury (OR, 0.90; 95% CI, 0.58-1.39) between the groups were identified. CONCLUSIONS: Our analysis demonstrated that statin therapy is beneficial in improving operative and interventional outcomes and should be considered as part of the optimization strategy for prevention of adverse cardiovascular and cerebrovascular events and death.

Computational fluid dynamic analysis of the effect of morphologic features on distraction forces in fenestrated stent grafts.

OBJECTIVE: Secure fixation of endovascular stent grafts is essential for successful endovascular aneurysm repair. Hemodynamic distraction forces are generated by blood pressure and blood flow and act against fixation force to encourage migration that may eventually lead to late stent graft failure. The aim of this in silico study was to determine which morphologic features were associated with greater distraction force. METHODS: Computer models of 54 in situ fenestrated stent grafts were constructed from postoperative computed tomography scans by use of image processing software. Computational fluid dynamic analysis was then performed by use of a commercial finite volume solver with boundary conditions representative of peak systole. Distraction force results were obtained for each component of the stent graft. Distraction force was correlated with lumen cross-sectional area (XSA) at the inlet and outlet of components and was compared between groups of components, depending on the magnitude of four predefined angles within the aortoiliac territory that we describe in detail. RESULTS: Median total resultant distraction force (RDF) acting on the fenestrated proximal bodies was 4.8 N (1.3-15.7 N); bifurcated distal bodies, 5.6N (1.0-8.0 N); and limb extensions, 1.7 N (0.6-8.4N). Inlet XSA exhibited strong, positive correlation with total RDF in proximal body and distal body components (Spearman correlation coefficient ρ, 0.883 and 0.802, respectively). Outlet XSA exhibited a similarly strong, positive correlation with total RDF in limb extension components (ρ, 0.822). Outlet angulation ≥ 45 degrees was associated with greater total RDF in the limb extension components only (P = .004). CONCLUSIONS: For a given blood pressure, XSA was the most important morphologic determinant of total RDF. Angulation within the aorta was not large enough to influence this, whereas iliac angulation affecting outlet angulation of limb extension components was associated with significantly greater total RDF.

Closure technique after carotid endarterectomy influences local hemodynamics.

BACKGROUND: Meta-analysis supports patch angioplasty after carotid endarterectomy (CEA); however, studies indicate considerable variation in practice. The hemodynamic effect of a patch is unclear and this study attempted to elucidate this and guide patch width selection. METHODS: Four groups were selected: healthy volunteers and patients undergoing CEA with primary closure, trimmed patch (5 mm), or 8-mm patch angioplasty. Computer-generated three-dimensional models of carotid bifurcations were produced from transverse ultrasound images recorded at 1-mm intervals. Rapid prototyping generated models for flow visualization studies. Computational fluid dynamic studies were performed for each model and validated by flow visualization. Mean wall shear stress (WSS) and oscillatory shear index (OSI) maps were created for each model using pulsatile inflow at 300 mL/min. WSS of <0.4 Pa and OSI >0.3 were considered pathological, predisposing to accretion of intimal hyperplasia. The resultant WSS and OSI maps were compared. RESULTS: The four groups comprised 8 normal carotid arteries, 6 primary closures, 6 trimmed patches, and seven 8-mm patches. Flow visualization identified flow separation and recirculation at the bifurcation increased with a patch and was related to the patch width. Computational fluid dynamic identified that primary closure had the fewest areas of low WSS or elevated OSI but did have mild common carotid artery stenoses at the proximal arteriotomy that caused turbulence. Trimmed patches had more regions of abnormal WSS and OSI at the bifurcation, but 8-mm patches had the largest areas of deleteriously low WSS and high OSI. Qualitative comparison among the four groups confirmed that incorporation of a patch increased areas of low WSS and high OSI at the bifurcation and that this was related to patch width. CONCLUSIONS: Closure technique after CEA influences the hemodynamic profile. Patching does not appear to generate favorable flow dynamics. However, a trimmed 5-mm patch may offer hemodynamic benefits over an 8-mm patch and may be the preferred option.

Combined cardiac surgery and endovascular repair of abdominal aortic aneurysms.

PURPOSE: To report an initial experience of concomitant endovascular repair of abdominal aortic aneurysms (AAA) and cardiac surgery. METHODS: Records for 10 consecutive patients (all men; median age 68 years, range 60-79) with AAA treated by a multidisciplinary team at a tertiary specialist center were retrospectively reviewed. Each patient had independent indications for surgical correction of their cardiac disease and AAAs. The patients underwent endovascular aneurysm repair (EVAR) followed by cardiac surgery under the same anesthesia. Eight patients had concomitant coronary artery bypass grafting (CABG; 4 off-pump), 1 patient had CABG and left ventricular aneurysmectomy, and 1 patient required aortic root replacement. RESULTS: All combined procedures were performed successfully under a single general anesthesia and took a median of 508 minutes (range 425-625). Median intensive care stay was 3 days (range 2-4), while hospital stay was 8 days (range 7-21) days. There were no deaths in-hospital or within 30 days. Complications were minor and self-limiting; there were no instances of renal failure. At a median follow-up of 29 months (range 14-38), no EVAR-related secondary interventions were required. CONCLUSION: Concomitant EVAR and cardiac surgery delivered by a multidisciplinary team is feasible, appears safe, and eliminates the risk associated with staged operations. Improved patient satisfaction and efficient use of resources are potential advantages.

Migration of fenestrated aortic stent grafts.

OBJECTIVE: This article reports the incidence, timing, and related sequelae for proximal and distal migration of the Zenith Fenestrated AAA Endovascular Graft (Cook Medical, Bloomington, Ind) used to treat abdominal aortic aneurysms. METHOD: A prospectively maintained database at a tertiary referral hospital was used to identify 83 patients who underwent endovascular repair using the Zenith fenestrated stent graft. Inclusion criteria included a postoperative computed tomography (CT) scan within 6 weeks of implantation and at least one additional follow-up CT scan (>5 months) available electronically at our institution. Eligible patients underwent assessment of stent graft migration using a CT-based central luminal line (CLL) technique. The proximal and distal margins of the stent graft were measured using CLLs relative to vascular landmarks on all available follow-up CT scans. Migration was defined as stent graft movement ≥4 mm. RESULTS: Fifty-five patients were included in this study, mean age was 74 ± 7 years, and 89% were men. Mean preoperative aneurysm diameter was 67 ± 9 mm. In these 55 patients, fenestrations were applied to 162 target vessels with the commonest design accommodating two renal arteries (RAs) and the superior mesenteric artery (SMA). Median follow-up was 24 (range, 5-97) months; 80% of patients (n = 44) had both the proximal and two distal attachment sites assessed for evidence of migration. Twelve iliac limbs in 11 patients were excluded from analysis due to occlusion of one internal iliac artery precluding CLL assessment (n = 7), or image quality issues (n = 5). Using CLLs and based on those patients who exhibited migration, the median proximal and distal migration distances were +5.0 (range, +4.0 to +8.1) mm and -5.0 (range, -4.3 to -21.3) mm, respectively. Kaplan-Meier analysis for proximal migration revealed migration rates of 14% and 22% at 12 and 36 months, respectively. Distal migration rates were lower at 3% and 8%, respectively. There have been no incidences of late rupture or open conversion. Of the patients with proximal migration, two patients lost a single target vessel (two RAs) and three patients were reported to have target vessel stenosis (two SMAs, one RA). These cases did not require reintervention. CONCLUSIONS: Both suprarenal fabric extension and visceral artery stenting are known to provide additional fixation for fenestrated aortic stent grafts. Despite this, minor proximal migration still occurs in up to one quarter of fenestrated endovascular repair patients by 4 years. We believe this is mainly due to the engagement of the barbs of the anchoring stent. Distal migrations occur with lower frequency.

Fractured superior mesenteric artery stents after fenestrated endovascular aneurysm repair.

Stent fracture after fenestrated endovascular aneurysm repair is a recognized complication. In this report, we record the occurrence of superior mesenteric artery stent fractures in our series and describe the management of embolized stent fragments during secondary intervention.

Guidewire stiffness: what's in a name?

PURPOSE: To measure the stiffness of commonly used "stiff" guidewires in terms of their flexural modulus, an engineering parameter related to bending stiffness. METHODS: Eleven different intact stiff guidewires were selected to undergo a 3-point bending test performed using a tensile testing machine. Testing was performed on 3 new and intact specimens of each guidewire at 10 locations along the wire's length, excluding the floppy tip. The flexural modulus (in gigapascals, GPa) was calculated from the results of the bending test. RESULTS: The flexural modulus of the plain Amplatz wire was 9.5 GPa compared to 11.4 to 14.5 GPa for the "heavy duty" wires. Within the Amplatz family of guidewires, the flexural modulus was 17 GPa for the "stiff," 29.2 GPa for the "extra stiff," 60.3 GPa for the "super stiff," and 65.4 GPa for the "ultra stiff." The Backup Meier measured 139.6 GPa and the Lunderquist Extra Stiff 158.4 GPa. CONCLUSION: The Instructions for Use of some endovascular devices specify a wire type selected from a range of undefined "stiffness" descriptors. These descriptors have little correlation with the measured flexural modulus. Two guidewires with the description "extra stiff" can have a 5-fold difference in flexural modulus. We recommend that guidewire catalogues and packaging include the flexural modulus and that device manufacturers amend their Instructions for Use accordingly.

Magnitude of the forces acting on target vessel stents as a result of a mismatch between native aortic anatomy and fenestrated stent-grafts.

PURPOSE: To quantify the compression force acting on target vessel stents as a consequence of the misalignment between the native aortic anatomy and the fenestrated stent-graft owing to measuring errors during the design of the device. METHODS: The material properties of a fenestrated Zenith stent-graft were determined using a standardized tensile testing protocol. Aortic anatomy was modeled using fresh porcine aortas that were subjected to tensile testing. The net force acting on a target vessel stent due to incremental discrepancy between the target vessel ostia and the stent-graft fenestrations was calculated as the difference in wall tension between the aorta and the stent-graft in diastole and systole. The change in diameter between diastole and systole was set to 8%. RESULTS: Using the diastole model, underestimation of circumferential target vessel position by 15°, 22.5°, and 30° resulted in net forces on the target vessel stent of 0.6, 0.8, and 1.1 N, respectively. Overestimation of target vessel position by the same increments resulted in net forces of 0.3, 0.6, and 0.9 N, respectively. With the systolic model, underestimating target vessel position by 30° resulted in a 2.1-N maximum force on the stent, which potentially threatened the seal. In the longitudinal direction, underestimating target vessel separation by up to 10 mm resulted in a maximal force on the stent of 6.1 N, while overestimating target vessel separation did not result in any additional force on the stent due to fabric infolding. CONCLUSION: The magnitude of the forces generated solely due to mismatch between stent-graft design and native anatomy is modest and is unlikely to cause significant deformation of target vessel stents. Mismatch, however, may cause loss of seal.

Intra- and interobserver variability of target vessel measurement for fenestrated endovascular aneurysm repair.

PURPOSE: To evaluate intra- and interobserver agreement of target vessel measured from computed tomography (CT) scans with 2 measuring techniques used in planning fenestrated endovascular aneurysm repairs (FEVAR): multiplanar reconstruction (MPR) and semi-automated central lumen line (CLL). METHODS: CT datasets from 25 FEVAR patients were independently analyzed by 2 experienced observers according to a standardized protocol using the MPR (Leonardo workstation) and CLL (Aquarius workstation) techniques for each patient. Longitudinal vessel separation and clock-face position of the visceral aortic branches were measured twice. The repeatability coefficient (RC) was calculated using the Bland and Altman method to measure intra- and interobserver variability. Differences between groups were examined by paired t test (continuous data) or chi-squared analysis (categorical). Clock-face discrepancy >30 minutes was considered significant. RESULTS: Intraobserver mean difference was insignificant regardless of the measurement technique: the observer and workstation-specific RCs varied between 3.9 and 4.9 mm. Paired measurements differed by >3 mm in 8%. Interobserver variability was greater: observer and workstation-specific RC varied between 5.6 and 7.4 mm, with a tendency toward consistency using MPR, although the mean difference was insignificant. Paired measurements differed by >3 mm in 18%. There was no significant intraobserver variation in clock-face measurement, while interobserver variation was significant in 12% of measurements using the Aquarius workstation and 6% using the Leonardo workstation (p = 0.19). CONCLUSION: Subjective interpretation of anatomical landmarks is more important than measurement techniques or workstations used in the generation of measurement inconsistencies. Introduction of consensus regarding interpretation of anatomical detail and development of fenestrated stent-grafts tolerant of measurement errors might ameliorate some of the problems encountered in FEVAR.

Adjunctive iliac stents reduce the risk of stent-graft limb occlusion following endovascular aneurysm repair with the Zenith stent-graft.

PURPOSE: To determine whether the introduction of a policy of adjunctive stent insertion based on preoperative CT assessment or completion angiography reduced the incidence of limb occlusion after stent-graft implantation for endovascular aneurysm repair (EVAR). METHODS: A tertiary referral unit's endovascular database was retrospectively interrogated to compare the incidence of endograft limb occlusion in Zenith grafts following the introduction of a policy of selective adjunctive stent insertion. Group A included 288 limbs at risk in 146 patients (134 men; mean age 74+/-8 years) treated prior to August 2005 in whom adjunctive stents were inserted on an ad hoc basis only. Group B included 293 limbs at risk in 149 patients (127 men; mean age 76+/-7 years) treated after this date in whom a more aggressive adjunctive stenting strategy was adopted. Kaplan-Meier analysis was employed to compare outcomes. RESULTS: In total, 295 patients underwent EVAR involving 581 iliac vessels, of which 11 (1.8%) occluded at a median of 24 months (0-27). Of 65 limbs extended into the external iliac segment, 5 (7.6%) subsequently occluded; in the remaining 516 limbs, there were 6 (1.1%) occlusions (p = 0.004). Across the study group, 38 (6.5%) adjunctive stents were deployed in limbs deemed at risk; 1 (2.6%) of these occluded. In the remaining 543 unstented limbs, 10 (1.8%) occlusions occurred (p = 0.15). There were 11 occlusions in group A, in which 5 (1.7%) adjunctive stents had been deployed, but none in group B, which had received 33 (11.2%) stents (p<0.0001). Kaplan-Meier survival curves identified primary patency rates at 36 months of 96% and 100%, respectively (p = 0.001). CONCLUSION: Adjunctive stenting significantly reduces the risk of postoperative stent-graft limb occlusion without obvious compromise to the aneurysm repair.