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.

In-hospital cost-effectiveness analysis of open versus staged fenestrated/branched endovascular elective repair of thoracoabdominal aneurysms.

OBJECTIVE: To compare costs and effectiveness of elective open (OR) vs fenestrated/branched endovascular (ER) repair of thoracoabdominal aneurysms (TAAAs) in a high-volume center. METHODS: This single-center retrospective observational study (PRO-ENDO TAAA Study, NCT05266781) was designed as part of a larger health technology assessment analysis. All electively treated TAAAs between 2013 and 2021 were analyzed and propensity-matched. End points were clinical success, major adverse events (MAEs), hospital direct costs, and freedom from all causes and aneurysm-related mortality and reinterventions. Risk factors and outcomes were homogeneously classified according to the Society of Vascular Surgery reporting standards. Cost-effectiveness value and incremental cost-effectiveness ratio were calculated, considering the absence of MAEs as a measure of effectiveness. RESULTS: Propensity matching identified 102 pairs of patients out of 789 TAAAs. Mortality, MAE, permanent spinal cord ischemia rates, respiratory complications, cardiac complications, and renal injury were higher for OR (13% vs 5%, P = .048; 60% vs 17%, P < .001; 10% vs 3%, P = .045; 91% vs 18%, P < .001; 16% vs 6%, P = .024; 27% vs 6%, P < .001, respectively). Access complication rate (6% vs 27%; P < .001) was higher in the ER group. Intensive care unit stay was longer (P < .001) for OR, and ER patients were discharged home more frequently (3% vs 94%; P < .001). No differences in midterm end points were observed at 2 years. Despite ER reducing all the hospital cost items (-42% to -88%, P < .001), the higher expenses (P < .001) of the endovascular devices increased the overall cost of ER by 80%. Cost-effectiveness value for ER was favorable to OR (56,365 vs 64,903 €/patient) with an incremental cost-effectiveness ratio of 48,409 € per MAE saved. CONCLUSIONS: ER of TAAA reduces perioperative mortality and morbidity compared with OR, with no differences in reinterventions and survival rates at midterm follow-up. Despite the expenses for endovascular grafts, ER was found to be more cost-effective in preventing MAEs.

An observational assessment of aortic deformation during infrarenal and complex endovascular aortic aneurysm repair.

OBJECTIVE: Real-time aortic deformation during endovascular aortic aneurysm repair (EVAR) has not been reported. Successful EVAR relies on predicting intraoperative aortic-endograft deformation from preoperative imaging. Correct prediction is essential, because malalignment of endografts decreases patient survival. We describe intraoperative aortic deformation during infrarenal EVAR and complex fenestrated/branched EVAR (F/BEVAR), relating deformation to preoperative anatomy and follow-up outcomes. METHODS: A multicenter, retrospective cohort of aortic aneurysm patients undergoing operation between January 2019 and February 2021, substratified by repair, infrarenal EVAR (n = 50), F/BEVAR (n = 80), and iliac branch graft with F/B/EVAR (IBG + F/B/EVAR; n = 27), were compared using software-based nonrigid two- and three-dimensional aortic deformational intraoperative assessment (CYDAR). Preoperative computed tomography reconstructions of aortic and iliac tortuosities were assessed against intraoperative deformation, the primary outcome, and related to perioperative and follow-up adverse outcomes. RESULTS: All treatment groups had low preoperative visceral aortic tortuosity; the EVAR group had higher iliac tortuosity (1.43 ± 0.05; P = .018). Intraoperative aortic visceral deformation was consistently cranial and anterior; IBG + F/B/EVAR patients had the largest magnitude deformation (superior mesenteric artery, EVAR 5.1 ± 0.9 mm; F/BEVAR 4.4 ± 0.4 mm; IBG 8.3 ± 1.2 mm; P = .004). Celiac artery, superior mesenteric artery, and bilateral renal artery deformations were correlated (R = 0.923-0.983). Iliac deformation was variable in magnitude and direction. Preoperative tortuosity was not correlated with the magnitude of intraoperative deformation nor was deformation magnitude related to endograft instability during follow-up, including endoleak development, reinterventions, or visceral vessel complications. CONCLUSIONS: The aorta deforms consistently during EVAR at the visceral aortic segment but unpredictably at the iliac bifurcation. Aortoiliac deformation is unrelated to adverse perioperative outcomes, branch instability, or reinterventions during short-term follow-up.

Stent-graft placement for hepatic arterial bleeding: assessment of technical efficacy and clinical outcome in a tertiary care center.

BACKGROUND: To evaluate technical and clinical results of stent-graft (SG) placement for bleeding from the hepatic artery (HA). METHODS: All patients intended and treated with SG deployment for bleeding from the HA at single center from January 2012 to May 2020 were retrospectively identified, and procedural details, risk factors for rebleeding, SG occlusion and mortality were analyzed. RESULTS: Twenty-seven patients (mean age 68.8 ± 10.1) were identified, and 25 patients underwent 26 SG procedures. Twenty-four patients had recent surgery. The technical success rate was 92.8%. Three patients (3/25) had rebleeding (88% clinical success). Intensive-care need before the procedure (p = 0.013) and smaller stent-graft size (≤4 mm, p = 0.032) were related to clinical failure. Twenty-two patients had follow-up imaging. The SG maintained patency in 10 (45.4%) patients at the most recent imaging. Only placement of SG distal to the HA bifurcation (p = 0.012) was related to occlusion. The 30-day and in-hospital mortality rate after SG was 8% and 24%. In-hospital mortality was associated with the intraabdominal septic source (p = 0.010) and revision surgery (p = 0.001). CONCLUSION: Stent-grafts are effective in the emergent treatment of HA bleeding. Mortality is mainly related to the general condition of the patient, and stent-grafts offer time to treat underlying medical problems sufficiently.

Prospective Assessment of a Protocol Using Neuromonitoring, Early Limb Reperfusion, and Selective Temporary Aneurysm Sac Perfusion to Prevent Spinal Cord Injury During Fenestrated-branched Endovascular Aortic Repair.

OBJECTIVE: The aim of this study was to analyze the outcomes of a standardized protocol using routine CSFD, neuromonitoring, LL reperfusion, and selective TASP to prevent SCI during F-BEVAR. BACKGROUND: SCI is to be the most devastating complication for the patient, family, and surgeon, with impact on patient's quality of life and long-term prognosis. An optimal standardized protocol may be used to improve outcomes. METHODS: Patients enrolled in a prospective, nonrandomized single-center study between 2013 and 2018. A SCI prevention protocol was used for TAAAS or complex abdominal aneurysms with ≥5-cm supraceliac coverage including CSFD, neuromonitoring, LL reperfusion, and selective TASP. Endpoints included mortality and rates of SCI. RESULTS: SCI prevention protocol was used in 170 of 232 patients (73%) treated by F-BEVAR. Ninety-one patients (55%) had changes in neuromonitoring, which improved with maneuvers in all except for 9 patients (10%) who had TASP. There was one 30-day or in-hospital mortality (0.4%). Ten patients (4%) developed SCIs including in 1% (1/79) of patients with normal neuromonitoring and 10% (9/91) of those who had decline in neuromonitoring ( P = 0.02). Permanent paraplegia occurred in 2 patients (1%). Factors associated with SCI included total operating time (odds ratio 1.5, 95% confidence interval 1.1-2.2, P = 0.02) and persistent changes in neuromonitoring requiring TASP (odds ratio 15.7, 95% confidence interval 2.9-86.2, P = 0.001). CONCLUSION: This prospective nonrandomized study using a standardized strategy to prevent SCI was associated with low incidence of the SCI during F-BEVAR. Permanent paraplegia occurred in 1%.

Current assessment and management of endoleaks after advanced EVAR: new devices, new endoleaks?

INTRODUCTION: In recent years there has been an increasing application of advanced EVAR techniques to tackle complex clinical and anatomical scenarios. In a bid to overcome the limitations of the traditional stent-grafts, newer EVAR endografts and techniques have been developed and introduced into clinical practice, permitting endovascular management of difficult infrarenal, juxta-renal and thoracoabdominal aneurysms for which previously there was no endovascular solution. As a consequence, we are now confronted with unique patterns of endoleak requiring customized clinical-radiological assessment and treatment. Despite the increasing body of evidence regarding new EVAR techniques and related endoleaks, current guidelines do not specifically address these issues. OBJECTIVES: Our review aims to assess risk factors, development, and management strategies of these endoleaks, in the most recent infrarenal EVAR devices and in more complex fenestrated EVAR (FEVAR) and Chimney EVAR (Ch-EVAR). EXPERT OPINION: Most new devices have demonstrated types of endoleaks that need specific imaging and treatment, as in EVAS, FEVAR, and ChEVAR. Knowledge of specific stent-graft characteristics and the nature of endoleaks associated with the various procedures facilitates the application of relevant useful imaging. In addition, it should aid development of a customized and practically relevant approach to patient management during intervention and follow-up.

Volume Change after Endovascular Treatment of Common Iliac Arteries ≥ 17 mm Diameter: Assessment of Type 1b Endoleak Risk Factors.

OBJECTIVE: The aim of this study was to assess the post-operative volumetric evolution of common iliac arteries (CIA) ≥ 17 mm diameter with respect to the type of endovascular technique performed and to assess type 1b endoleak risk factors. METHODS: All consecutive patients presenting with aneurysmal disease with CIA ≥17 mm treated endovascularly from 2008 to 2016 were included. Patients were divided into two groups dependent upon the type of endovascular technique performed: bell bottom technique (BBT group), vs. other techniques (non-BBT group). Volumetric evolution of the CIA was assessed for each patient by computed tomography angiographic reconstructions performed pre-operatively, at six months, one year, and two years. Multivariable analysis was performed to identify risk factors for type 1b endoleak. RESULTS: From 2008 to 2016, 74 patients with 110 CIA ≥17 mm were treated (BBT group: n = 58; non-BBT group: n = 52). Mean follow up was 48.1 months (median 39.0, IQR 38.1). Mean volumetric evolution significantly differed in the BBT group +14.2% (median 19.9%, IQR 24.6) compared with the non-BBT group: -20.9% (median -20.1%, IQR -26.0), p < .001. The five year type 1b endoleak related re-intervention rate was 16.1% and 7.7% in the BBT and non-BBT groups, respectively (p = .04), mean time to type 1b endoleak was 24.8 months and 54.3 months, respectively. The BBT appeared as a risk factor for type 1b endoleak (OR: 7.13; 95% CI: 1.58-3.04; p < .001). CONCLUSION: The BBT is associated with an increase in CIA volume post-operatively and consequently can be considered a risk factor for type 1b endoleak. It might be avoided if an iliac branched endograft is possible.

A systematic review of standardized methods for assessment of endograft sealing on computed tomography angiography post-endovascular aortic repair, and its influence on endograft-associated complications.

Introduction: Although there is much attention for proper sizing of pre-operative anatomy before (thoracic) endovascular aneurysm repair ([T]EVAR), standardized assessment of endograft position and apposition at postoperative imaging is seldom addressed in the international guidelines. The highly detailed three-dimensional computed tomography angiography (CTA) volumes contain valuable information about the apposition of the endograft with the arterial wall and the position of the device relative to anatomical landmarks in the proximal and distal landing zones, which is currently hardly used. With proper assessment on CTA of the endograft after EVAR, the risk for future endograft-related complications may be determined, allowing patient-tailored, risk-stratified surveillance. Areas covered: This systematic review identified three standardized methods for assessing apposition or position of the endograft in the proximal or distal landing zone on CTA after (T)EVAR. Quantification of apposition and position, validation of measurement precision, and association with endograft-related complications were extracted. Short (<10 mm apposition length) and decreasing (>0 mm) apposition were associated with endograft-associated complications. Expert commentary: Standardized assessment of apposition and position of the endograft in the proximal and distal landing zones on CTA should be incorporated in post-(T)EVAR surveillance. A risk-stratified CTA surveillance protocol is proposed.

Incidence, Management, and Outcomes of Aortic Graft Infection.

BACKGROUND: Infection complicates 1% of aortic grafts, and although uncommon, the associated morbidity and mortality are significant. We sought to determine risk factors for aortic graft infection (AGI), the long-term outcomes in patients managed both nonoperatively and via explantation. METHODS: This observational study reviewed sequential aortic grafts (thoracic or abdominal) inserted via open or endovascular means between 2000 and 2017. We used Cox proportional hazards regression analyses to compare risk factors between groups who did and did not acquire an AGI and recorded method of management, morbidity, mortality, and duration to adverse event. RESULTS: There were 883 aortic repairs, 49% were endovascular. 17.2% were for ruptured aneurysms, 1.1% for symptomatic aneurysms, 1.4% for type B dissections, and 0.5% for occlusive disease. Twelve patients presented with AGI, of which ten had their index procedure performed at our institution (AGI incidence of 1.1%). There was no difference in rates of AGI between open and endovascular repairs (0.9 vs. 1.4%, P = 0.24). AGI was significantly associated with emergency aortic repair (HR 3.63, 95% CI 1.13-11.57, P = 0.03), septic process requiring in-patient management during follow-up (HR 5.44, 95% CI 1.21-24.26, P = 0.02), and suprarenal clamping during open repair (HR 5.21, 95% CI 1.00-26.99, P = 0.05). Four patients were managed with explantation and revascularization (3 extra-anatomical bypasses) and remained well at a median follow-up of 46 months. Of the 8 patients managed nonoperatively, 4 died at an average of 13.5 days after representation, and the other 4 remained well on oral antibiotics at a median follow-up of 26.5 months. No patient suffered limb loss, and there was no change in the rate of infection over the period. CONCLUSIONS: Incidence of AGI remains low but is associated with significant mortality. Patients with aortic grafts in situ require aggressive treatment of septic foci to prevent graft infection.

[Use of contrast-enhanced ultrasound for assessment of the state of femoropopliteal bypass graft anastomoses]. / Primenenie kontrastnoi sonografii dlia otsenki sostoianiia anastomozov bedrenno-podkolennykh shuntov.

Analysed herein is the experience of the first eight ultrasonographic studies of peripheral arteries with dynamic contrast enhancement using sulphur hexafluoride («SonoVue¼) carried out in patients after previously performed femoropopliteal bypass grafting with a synthetic prosthesis (in seven cases the distal anastomosis of the bypass graft was located below the fissure of the knee joint and in one case - above the fissure of the knee joint). Contrast-enhanced ultrasonography was performed averagely 12.5±4.0 months after the operation, according to the technique recommended by the manufacturer of the contrast agent. It was demonstrated that control ultrasonic scanning of lower-limb arteries using contrast enhancement in the remote period after bypass operations proved more informative in relation to detection of stenoses of the distal anastomosis of the femoropopliteal bypass graft, trifurcation of the popliteal artery and near-ostium segments of tibial arteries than a study with no contrast medium.

Current treatment status and medical costs for hemodialysis vascular access based on analysis of the Korean Health Insurance Database.

BACKGROUND/AIMS: The Republic of Korea is a country where the hemodialysis population is growing rapidly. It is believed that the numbers of treatments related to vascular access-related complications are also increasing. This study investigated the current status of treatment and medical expenses for vascular access in Korean patients on hemodialysis. METHODS: This was a descriptive observational study. We inspected the insurance claims of patients with chronic kidney disease who underwent hemodialysis between January 2008 and December 2016. We calculated descriptive statistics of the frequencies and medical expenses of procedures for vascular access. RESULTS: The national medical expenses for access-related treatment were 7.12 billion KRW (equivalent to 6.36 million USD) in 2008, and these expenses increased to 42.12 billion KRW (equivalent to 37.67 million USD) in 2016. The population of hemodialysis patients, the annual frequency of access-related procedures, and the total medical cost for access-related procedures increased by 1.6-, 2.6-, and 5.9-fold, respectively, over the past 9 years. The frequency and costs of access care increased as the number of patients on hemodialysis increased. The increase in vascular access-related costs has largely been driven by increased numbers of percutaneous angioplasty. CONCLUSION: The increasing proportion of medical costs for percutaneous angioplasty represents a challenge in the management of end-stage renal disease in Korea. It is essential to identify the clinical and physiological aspects as well as anatomical abnormalities before planning angioplasty. A timely surgical correction could be a viable option to control the rapid growth of access-related medical expenses.

Utilization, patency, and complications associated with vascular access for hemodialysis in the United States.

BACKGROUND: This study examines the utilization and outcomes of vascular access for long-term hemodialysis in the United States and describes the impact of temporizing catheter use on outcomes. We aimed to evaluate the prevalence, patency, and associated patient survival for pre-emptively placed autogenous fistulas and prosthetic grafts; for autogenous fistulas and prosthetic grafts placed after a temporizing catheter; and for hemodialysis catheters that remained in use. METHODS: We performed a retrospective study of all patients who initiated hemodialysis in the United States during a 5-year period (2007-2011). The United States Renal Data System-Medicare matched national database was used to compare outcomes after pre-emptive autogenous fistulas, preemptive prosthetic grafts, autogenous fistula after temporizing catheter, prosthetic graft after temporizing catheter, and persistent catheter use. Outcomes were primary patency, primary assisted patency, secondary patency, maturation, catheter-free dialysis, severe access infection, and mortality. RESULTS: There were 73,884 (16%) patients who initiated hemodialysis with autogenous fistula, 16,533 (3%) who initiated hemodialysis with prosthetic grafts, 106,797 (22%) who temporized with hemodialysis catheter prior to autogenous fistula use, 32,890 (7%) who temporized with catheter prior to prosthetic graft use, and 246,822 (52%) patients who remained on the catheter. Maturation rate and median time to maturation were 79% vs 84% and 47 days vs 29 days for pre-emptively placed autogenous fistulas vs prosthetic grafts. Primary patency (adjusted hazard ratio [aHR], 1.26; 95% confidence interval [CI], 1.25-1.28; P < .001) and primary assisted patency (aHR, 1.36; 95% CI, 1.35-1.38; P < .001) were significantly higher for autogenous fistula compared with prosthetic grafts. Secondary patency was higher for autogenous fistulas beyond 2 months (aHR, 1.36; 95% CI, 1.32-1.40; P < .001). Severe infection (aHR, 9.6; 95% CI, 8.86-10.36; P < .001) and mortality (aHR, 1.29; 95% CI, 1.27-1.31; P < .001) were higher for prosthetic grafts compared with autogenous fistulas. Temporizing with a catheter was associated with a 51% increase in mortality (aHR, 1.51; 95% CI, 1.48-1.53; P < .001), 69% decrease in primary patency (aHR, 0.31; 95% CI, 0.31-0.32; P < .001), and 130% increase in severe infection (aHR, 2.3; 95% CI, 2.2-2.5; P < .001) compared to initiation with autogenous fistulas or prosthetic grafts. Mortality was 2.2 times higher for patients who remained on catheters compared to those who initiated hemodialysis with autogenous fistulas (aHR, 2.25; 95% CI, 2.21-2.28; P < .001). CONCLUSIONS: Temporizing catheter use was associated with higher mortality, higher infection, and lower patency, thus undermining the highly prevalent approach of electively using catheters as a bridge to permanent access. Autogenous fistulas are associated with longer time to catheter-free dialysis but better patency, lower infection risk, and lower mortality compared with prosthetic grafts in the general population.

Multicenter Assessment of Grafts in Coronaries: Midterm Evaluation of the C-Port Device (the MAGIC Study).

OBJECTIVE: The commercially available C-Port distal anastomotic device (Food and Drug Administration cleared in 2007) is an automated miniature vascular stapler that performs the coronary anastomosis. This prospective multicenter registry sought to evaluate midterm patency using this device compared with hand-sewn grafts. METHODS: Patients receiving at least one C-Port anastomosis during coronary artery bypass grafting surgery were enrolled at eight sites. Of the 117 patients enrolled, 78 patients (67%) with 104 C-Port vein grafts completed the study to patency assessment via computed tomography angiography. Clinical follow-up and index graft patency (Gated 64-slice computed tomography scan) were performed at least 12 months postoperatively. The primary efficacy endpoint was patency compared with the peer-reviewed results from the PRoject of Ex-vivo Vein graft ENgineering via Transfection IV (PREVENT IV) trial. RESULTS: The patient population was consistent with the PREVENT IV placebo cohort. The mortality at 12 months was 0.85% (1/117). The major cardiac morbidity rate was 3.4% (4/117). The C-Port vein graft occlusion rate was 16.3% (17/104) compared with 26.6% (597/2242) in the PREVENT IV trial (P = 0.011). Within this study, C-Port graft occlusion rates were not significantly different from the hand-sewn grafts (P = 0.821). CONCLUSIONS: The C-Port device is safe and effective in creating the distal anastomosis with equivalent patency rates to hand-sewn grafts at 12 months. When compared with hand-sewn anastomoses from a recent large prospective trial, the C-Port device demonstrated a statistically significant reduction in midterm graft occlusion. Further studies are required to evaluate its effect in less invasive coronary surgery.

Postoperative initial 2-day blood pressure management facilitates the shrinkage of abdominal aortic aneurysm after endovascular aneurysm repair by reducing the incidence of type II endoleak.

OBJECTIVE: The aim of this study was to evaluate the effect of initial 2-day blood pressure management (BPM) after endovascular aneurysm repair (EVAR) for the incidence of subsequent type II endoleak (T2E) and shrinkage of abdominal aortic aneurysm (AAA) sac diameter. METHODS: We reviewed 136 patients who underwent EVAR for atherosclerotic AAA between July 2008 and July 2014 with one of three stent grafts (Excluder [W. L. Gore & Associates, Flagstaff, Ariz], Powerlink [Endologix Inc, Irvine, Calif], and Endurant [Medtronic Vascular, Santa Rosa, Calif]). Starting from 2013, the mean blood pressure of 76 participating patients (treatment group) was maintained at 75 to 90 mm Hg for the initial 48 hours after EVAR. The incidence of T2E at 7 days and AAA sac diameter 12 months after EVAR were evaluated using computed tomography scanning. The results so obtained were then compared with those of the control group composed of 60 consecutive patients who underwent EVAR before 2013. RESULTS: The incidence of T2E at 7 days was significantly lower in patients who received treatment (treatment group, 19.7%; control group, 40.0%; P = .013), and AAA sac diameter at 12 months in the treatment group had a mean decrease of 5.1 mm compared with the mean 2.2 mm in the control group (P = .004). In multivariate regression analysis, BPM was significantly related to the reduction of incidence of T2E at 7 days (odds ratio, 0.31; P = .007) and a decrease in AAA sac diameter at 12 months (P = .005). In addition, although the use of Endurant had less effect, the use of Excluder under controlled blood pressure conditions improved the incidence of T2E from 80% to 23% compared with those under normal postoperative management (P = .001). CONCLUSIONS: The initial 2-day postoperative BPM might have positive effects, such as lower incidence of T2E and facilitation of AAA sac shrinkage.

Overstenting the hypogastric artery during endovascular aneurysm repair with and without prior coil embolization: A comparative analysis from the ENGAGE Registry.

BACKGROUND: Endovascular aneurysm repair of aortoiliac or iliac aneurysms is often performed with stent graft coverage of the origin of the hypogastric artery (HA) to ensure adequate distal seal. It is considered common practice to perform adjunctive coiling of the HA to prevent a type II endoleak. Our objective was to question the necessity of pre-emptive coiling by comparing the outcomes of HA coverage with and without prior coil embolization. METHODS: Data from the Endurant Stent Graft Natural Selection Global Postmarket Registry (ENGAGE), which prospectively enrolled 1263 endovascular aneurysm repair patients between March 2009 and April 2011 from multiple centers worldwide, were used for this study. We identified patients in whom the Endurant stent graft (Medtronic Vascular, Santa Rosa, Calif) covered one or both HAs and grouped them into cases in which prior HA embolization-coils or plugs-was performed (CE) and cases in which HA embolization was not performed (NE). The occurrence of covered HA-related endoleak and secondary interventions were compared between groups. RESULTS: In 197 patients, 225 HAs were covered. Ninety-one HAs were covered after coil embolization (CE group), and 134 HAs were covered without prior coil embolization (NE group). Both groups were similar at baseline and had comparable length of follow-up to last image (665.2 ± 321.7 days for CE patients; 641.6 ± 327.6 days for NE patients; P = .464). Importantly, both groups showed equivalent iliac morphology concerning common iliac artery proximal, mid, and distal dimensions and tortuosity, making them suitable for comparative analysis. During follow-up, HA-related endoleaks were sparse and occurred equally often in both groups (CE 5.5% vs NE 3.0%; P = .346). Secondary intervention to resolve an HA-related endoleak was performed twice in the CE group and three times in the NE group. Late non-HA-related endoleaks occurred more often in the CE group compared with the NE group, (25.0% vs 15.0%; P = .080). Secondary interventions for other reasons than HA-related endoleaks occurred in 7.5% of NE cases and 15.4% of CE cases (P = .057), mostly for occlusions in the ipsilateral iliac limb. During follow-up, 19 NE patients and 9 CE patients died, which is not significantly different (P = .225), and no deaths were related directly or indirectly to HA coverage. Also, no reports of gluteal necrosis and bowel ischemia were made. CONCLUSIONS: This study shows that HA coverage with the Endurant endograft without prior coil embolization does not increase the incidence of endoleak or related secondary interventions. These findings together with the already available evidence suggest that omission of coil embolization may be a more resource-effective strategy whenever HA coverage is required.

Select early type IA endoleaks after endovascular aneurysm repair will resolve without secondary intervention.

OBJECTIVE: Although it is traditionally considered ominous, the natural history of early proximal attachment site endoleaks (IA) after endovascular aneurysm repair (EVAR) is not well known. Our aim was to identify risk factors for persistent type IA endoleaks and to determine their effect on long-term outcomes after EVAR. METHODS: All patients who underwent infrarenal EVAR at a single institution between 1998 and 2015 were identified. Preoperative axial imaging and intraoperative arteriograms were reviewed, and those patients with a type IA endoleak were further studied. Aneurysm features were characterized by two reviewers and were studied for predictors of persistent endoleaks at the conclusion of the case. Patient records and the Social Security Death Index were used to record 1-year and overall survival. RESULTS: We identified 1484 EVARs, 122 (8%) of which were complicated by a type IA endoleak on arteriography after graft deployment, with a median follow-up of 4 years. The majority of patients underwent additional ballooning of the proximal site (52 [43%]) or placement of an aortic cuff (47 [39%]); 30 patients (25%) received a Palmaz stent, and four patients were treated with coils or anchors. At case end, only 43 (35%) of the type IA endoleaks remained; at 1 month, only 16 endoleaks persisted (13%), and only six persisted at 1 year (6%). In multivariable analysis, the only independent predictor of persistence of type IA endoleak at the conclusion of the case was the presence of extensive neck calcifications (odds ratio [OR], 9.9; 95% confidence interval [CI], 1.4-67.9; P = .02). Thirteen patients (11%) underwent reintervention for type IA endoleaks, with a time frame ranging from 3 days postoperatively to 11 years. There were three patients (2.4%) who experienced aneurysm rupture. Postoperative type IA endoleak was associated with lower survival at 1 year (79% vs 91%; relative risk, 2.5; 95% CI, 1.1-5.4; P = .02), but it did not affect long-term survival (log-rank, P = .45). Both an increase in aneurysm sac size and failure of the endoleak to resolve by case end were independent predictors of a need for reintervention (growth: OR, 8.3; 95% CI, 2.2-31.6; P < .01; persistent endoleak: OR, 7.6; 95% CI, 1.8-31.5; P < .01). A persistent type IA endoleak was not independently associated with an increase in sac size on surveillance imaging (P = .28). CONCLUSIONS: Aneurysm rupture secondary to persistent type IA endoleak is rare, and most will resolve within 1 year. Extensive neck calcification is the only independent predictor of persistent type IA endoleak, and an increase in sac size warrants reintervention. These data suggest that select early persistent type IA endoleaks can be safely observed.

Cryopreserved venous allograft is an acceptable conduit in patients with current or prior angioaccess graft infection.

OBJECTIVE: The durability of cryopreserved allograft has been previously demonstrated in the setting of infection. The objective of this study was to examine the safety, efficacy, patency, and cost per day of graft patency associated with using cryopreserved allograft (vein and artery) for hemodialysis access in patients with no autogenous tissue for native fistula creation and with arteriovenous graft infection or in patients at high risk for infection. METHODS: Patients implanted with cryopreserved allograft for hemodialysis access between January 2004 and January 2014 were reviewed using a standardized, multi-institutional database that evaluated demographic, comorbidity, procedural, and outcomes data. RESULTS: There were 457 patients who underwent placement of cryopreserved vein (femoral: n = 337, saphenous: n = 11) or artery (femoral: n = 109) for hemodialysis access at 20 hospitals. Primary indications for allograft use included high risk of infection in 191 patients (42%), history of infected prosthetic graft in 169 (37%), and current infection in 97 (21%). Grafts were placed more frequently in the arm (78%) than in the groin, with no difference in allograft conduit used. Mean time from placement to first hemodialysis use was 46 days (median, 34 days). Duration of functional graft use was 40 ± 7 months for cryopreserved vein and 21 ± 8 months for cryopreserved artery (P < .05), and mean number of procedures required to maintain patency at follow-up of 58 ± 21 months was 1.6 for artery and 0.9 for vein (P < .05). Local access complications occurred in 32% of patients and included late thrombosis (14%), graft stenosis (9%), late infection (9%), arteriovenous access malfunction (7%), early thrombosis (3%), and early infection (3%). Early and late infections both occurred more frequently in the groin (P = .030, P = .017, respectively), and late thrombosis occurred more frequently with cryopreserved artery (P < .001). Of the 82 patients (18%) in whom the cryopreserved allograft was placed in the same location as the excised infected prosthetic graft, 13 had infection of the allograft during the study period (early: n = 4; late: n = 9), with no significant difference in infection rate (P = .312) compared with the remainder of the study population. The 1-, 3-, and 5-year primary patency was 58%, 35%, and 17% for cryopreserved femoral vein and 49%, 17%, and 8% for artery, respectively (P < .001). Secondary patency at 1, 3, and 5 years was 90%, 78%, and 58% for cryopreserved femoral vein and 75%, 53%, and 42% for artery, respectively (P < .001). Mean allograft fee per day of graft patency was $4.78 for cryopreserved vein and $6.97 for artery (P < .05), excluding interventional costs to maintain patency. CONCLUSIONS: Cryopreserved allograft provides an excellent conduit for angioaccess when autogenous tissue is not available in patients with current or past conduit infection. Cryopreserved vein was associated with higher patency and a lower cost per day of graft patency. Cryopreserved allograft allows for immediate reconstruction through areas of infection, reduces the need for staged procedures, and allows early use for dialysis.

A randomized controlled trial and cost-effectiveness analysis of early cannulation arteriovenous grafts versus tunneled central venous catheters in patients requiring urgent vascular access for hemodialysis.

OBJECTIVE: Early cannulation arteriovenous grafts (ecAVGs) are proposed as an alternative to tunneled central venous catheters (TCVCs) in patients requiring immediate vascular access for hemodialysis (HD). We compared bacteremia rates in patients treated with ecAVG and TCVC. METHODS: The study randomized 121 adult patients requiring urgent vascular access for HD in a 1:1 fashion to receive an ecAVG with or without (+/-) an arteriovenous fistula (AVF; n = 60) or TCVC+/-AVF (n = 61). Patients were excluded if they had active systemic sepsis, no anatomically suitable vessels, or an anticipated life expectancy <3 months. The primary end point was the culture-proven bacteremia rate at 6 months, with the trial powered to detect a reduction in bacteremia from 24% to 5% (α = .05, ß = .8). Secondary end points included thrombosis, reintervention, and mortality. A cost-effectiveness analysis was also performed. RESULTS: Culture-proven bacteremia developed in 10 patients (16.4%) in the TCVC arm ≤6 months compared with two (3.3%) in the ecAVG+/-AVF arm (risk ratio, 0.2; 95% confidence interval, 0.12-0.56; P = .02). Mortality was also higher in the TCVC+/-AVF cohort (16% [n = 10] vs 5% [n = 3]; risk ratio, 0.3; 95% CI, 0.08-0.45; P = .04). The difference in treatment cost between the two arms was not significant (£11,393 vs £9692; P = .24). CONCLUSIONS: Compared with TCVC+/-AVF, a strategy of ecAVG+/-AVF reduced the rate of culture-proven bacteremia and mortality in patients requiring urgent vascular access for HD. The strategy also proved to be cost-neutral.

Hemodialysis patients' satisfaction and perspectives on complications associated with vascular access related interventions: are we listening?

PURPOSE: To understand the patient's perspective on complications associated with vascular access-related interventions. METHODS: A multi-stage comprehensive questionnaire of over 150 items was administered to 140 in-center hemodialysis patients in a large, Toronto-based academic-based facility from May 1, 2011 until July 1, 2014. The questionnaire was divided into three domains: physical complications, disruption to routine, and infection. For each of the 12 prespecified vascular access interventions, there were 9 items about the associated complications. The level of bother associated with complications was measured using a 5-point Likert scale. RESULTS: The mean Likert value (5 = extremely bothered) for the physical complications domain was highest for grafts at 1.92, followed closely by fistulas at 1.87, and catheters at 1.56. The mean Likert value for the "disruption of routine" domain was highest for catheters at 1.44, followed by grafts at 1.37, and fistulas at 1.33. For infectious complications of all vascular access-related interventions the mean Likert value was highest at 1.76 for catheters as compared to fistulas at 1.23 and grafts at 1.22. CONCLUSIONS: For hemodialysis patients, the physical complications associated with needle cannulation of fistulas and grafts are a major source of dissatisfaction, while infectious complications, including catheter-related infections, are not a significant source of their concerns. Future research should focus on developing methods to effectively: (i) reduce the fear and pain associated with cannulation and (ii) educate patients about the risks associated with vascular access-related infection.