Clinical Performance of the Low Profile Zenith Alpha Abdominal Endovascular Graft: 2 Year Results from the ZEPHYR Registry.

OBJECTIVE: The midterm outcomes of the low profile Zenith Alpha Abdominal Endovascular Graft from the ZEnith alPHa for aneurYsm Repair (ZEPHYR) registry are reported. METHODS: The ZEPHYR registry is a physician initiated, multicentre, non-randomised, core laboratory controlled, prospective registry. Inclusion criteria were patients with a non-ruptured abdominal aortic aneurysm with a maximum diameter ≥ 50 mm or enlargement > 5 mm within 6 months, with a site reported infrarenal neck length of ≥ 10 mm and with the intention to electively implant the Zenith Alpha abdominal endograft. Patients from 14 sites across Germany, Belgium, and the Netherlands were included. The primary endpoint was treatment success, defined as technical success and clinical success. Technical success was defined as successful delivery and deployment of the endograft in the planned position without unintentional coverage of internal iliac or renal arteries, with successful removal of the delivery system. Clinical success was defined as freedom from aneurysm sac expansion > 5 mm, type I or type III endoleaks, aneurysm rupture, stent graft migration > 10 mm, open conversion, and stent graft occlusion. RESULTS: Three hundred and forty-seven patients were included in the ZEPHYR registry. The median clinical follow up was 743 days (interquartile range [IQR] 657, 806) with a median imaging follow up of 725 days (IQR 408, 788). Treatment success at 6 months, 1, and 2 years was 92.5%, 90.4%, and 85.3%, respectively. Freedom from secondary intervention was 94.3%, 93.4%, and 86.9%, respectively. The predominant reason for secondary intervention was limb complications. Freedom from limb occlusion (per patient) at 6 months, 1, and 2 years was 97.2%, 95.8%, and 92.5%, respectively. Univariable and multivariable Cox regression analyses could not identify any independent predictor for limb complications. CONCLUSION: While treatment success is comparable with other commercially available grafts, the rate of limb complications at 2 years is of concern. The manufacturer's instructions for use should be followed closely. Further studies are necessary to investigate the root cause of the increased rate of limb complications with the Zenith Alpha Abdominal Endovascular Graft.

Three-Year Safety and Efficacy of the INCRAFT Endograft for Treatment of Abdominal Aortic Aneurysms: Results of the INSIGHT Study.

PURPOSE: Preliminary results of the INSIGHT study showed that the low-profile INCRAFT Abdominal Aortic Aneurysm (AAA) Stent-Graft System was safe and effective in the endovascular aneurysm repair (EVAR). This study aimed to assess the durability and the midterm effectiveness of EVAR using the INCRAFT System in the framework of a multicenter, prospective, open-label, post-approval study. MATERIALS AND METHODS: Between 2015 and 2016, 150 subjects from 23 European centers treated with the INCRAFT System for an infrarenal AAA were included. Clinical and radiologic data were prospectively collected and analyzed using protocol-specified, monitored follow-up clinic visits at 1, 6, and 12 months post-implantation and annually after that. The clinical success at 3 years was determined. Freedom from overall and aneurysm-related mortality, type I endoleak, secondary interventions, and aneurysm sac enlargement through 3 years were evaluated. Kaplan-Meier estimates were used for late outcomes. An independent clinical events committee reviewed all events. The CT (computed tomography) scans through 1 year were reviewed by an independent core laboratory. RESULTS: The primary clinical success rate at 3 years was 84.0% (126/150). There were no aneurysm-related deaths, endograft migration, or aneurysm-related ruptures through 3 years. Stent fracture was detected in 2 subjects (1.3%) without clinical sequelae. Over 3 years, freedom from overall mortality was 89.4%, freedom from secondary interventions was 80%, and freedom from aneurysm sac enlargement was 96.5%. The 3-year freedom from type IA and IB endoleaks was 93.3% and 98.6%, respectively. CONCLUSIONS.: In a multicenter real-world study setting, the use of a low-profile INCRAFT device for AAA is associated with sustained clinical success and low rates of reinterventions through 3 years. CLINICAL IMPACT: Low-profile endografts have broadened the spectrum of patients with anatomic suitability for endovascular repair of abdominal aortic aneurysms (AAA). However, questions remain regarding the durability of the repair. The INSIGHT study evaluated the use of the INCRAFT System in routine real-world clinical practice, including patients with complex anatomies. The treatment was safe and effective. The results showed sustained clinical success over 3 years, with no aneurysm-related deaths or ruptures, and a high rate of intervention-free survival at 3 years. Despite the low-profile design of the endograft, the midterm results demonstrate the durability of AAA repair using the INCRAFT System.ClinicalTrials.gov Identifier: NCT02477111.

Focal Aortic Dissection With Significant Stenosis: A Rare Long Term Complication After TEVAR for Blunt Traumatic Aortic Injury in an Adolescent Patient.

Background: Thoracic endovascular aortic repair (TEVAR) in children and adolescents after blunt traumatic aortic injury (BTAI) is being performed increasingly despite no endovascular graft being approved for TEVAR in this population. The smaller diameter of the aorta and access vessels and steeper angle of the aortic arch pose specific challenges for TEVAR in this population. Moreover, data are lacking regarding medium to long term complications. This case presents an adolescent patient who underwent TEVAR for BTAI and suffered a focal aortic dissection several months later. Report: The patient initially presented after a motor vehicle accident and underwent an uncomplicated TEVAR procedure with a 28 mm diameter stent graft (the smallest device available at the time) for Grade III traumatic aortic dissection; the native aortic diameter was 15 mm. The diameter mismatch was accepted due to the lifesaving nature of the procedure. More than 7 months later the patient presented to the emergency department after not being able to urinate for several days and experiencing pain, tingling, and weakness in both legs. Blood samples showed a severe acute kidney injury and computed tomography angiography showed significant aortic stenosis in the distal part of the stent graft, probably caused by a focal dissection. The stenosis and dissection were successfully treated using a Palmaz stent, after which his renal function and extremity complaints recovered. Conclusion: The focal dissection was probably caused by stress on the aortic wall due to the aorta-stent graft diameter mismatch. This case demonstrates that complications after TEVAR in adolescents can arise months after the initial procedure and underscores the need for continued vigilance, especially in cases with an aorta-stent graft mismatch. The threshold for additional imaging and consultation by a vascular surgeon should be low.

Identifying Patients at High Risk for Post-EVAR Aneurysm Sac Growth.

PURPOSE: Post-EVAR (endovascular aneurysm repair) aneurysm sac growth can be seen as therapy failure as it is a risk factor for post-EVAR aneurysm rupture. This study sought to identify preoperative patient predictors for developing post-EVAR aneurysm sac growth. MATERIAL AND METHODS: A systematic review was conducted to select potential predictive preoperative factors for post-EVAR sac growth (including a total of 34.886 patients), which were evaluated by a retrospective single-center analysis of patients undergoing EVAR between 2009 and 2019 (N=247) with pre-EVAR computed tomography scans and at least 1 year follow-up. The primary study outcome was post-EVAR abdominal aortic aneurysm (AAA) sac enlargement (≥5 mm diameter increase). Multivariate Cox regression and Kaplan-Meier survival curves were constructed. RESULTS: Potential correlative factors for post-EVAR sac growth included in the cohort analysis were age, sex, anticoagulants, antiplatelets, renal insufficiency, anemia, low thrombocyte count, pulmonary comorbidities, aneurysm diameter, neck diameter, neck angle, neck length, configuration of intraluminal thrombus, common iliac artery diameter, the number of patent lumbar arteries, and a patent inferior mesenteric artery. Multivariate analysis showed that infrarenal neck angulation (hazard ratio, 1.014; confidence interval (CI), 1.001-1.026; p=0.034) and the number of patent lumbar arteries (hazard ratio, 1.340; CI, 1.131-1.588; p<0.001) were associated with post-EVAR growth. Difference in estimated freedom from post-EVAR sac growth for patients with ≥4 patent lumbar arteries versus <4 patent lumbar arteries became clear after 2 years: 88.5% versus 100%, respectively (p<0.001). Of note, 31% of the patients (n=51) with ≥4 patent lumbar arteries (n=167) developed post-EVAR sac growth. In our cohort, the median maximum AAA diameter was 57 mm (interquartile range [IQR] = 54-62) and the median postoperative follow-up time was 54 months (IQR = 34-79). In all, 23% (n=57) of the patients suffered from post-EVAR growth. The median time for post-EVAR growth was 37 months (IQR = 24-63). In 46 of the 57 post-EVAR growth cases (81%), an endoleak was observed; 2.4% (n=6) of the patients suffered from post-EVAR rupture. The total mortality in the cohort was 24% (n=60); 4% (n=10) was AAA related. CONCLUSIONS: This study showed that having 4 or more patent lumbar arteries is an important predictive factor for postoperative sac growth in patients undergoing EVAR. CLINICAL IMPACT: This study strongly suggests that having 4 or more patent lumbar arteries should be included in preoperative counseling for EVAR, in conjunction to the instructions for use (IFU).

Nationwide Outcomes of Octogenarians Following Open or Endovascular Management After Ruptured Abdominal Aortic Aneurysms.

PURPOSE: Octogenarians are known to have less-favorable outcomes following ruptured abdominal aortic aneurysm (rAAA) repair compared with their younger counterparts. Accurate information regarding perioperative outcomes following rAAA-repair is important to evaluate current treatment practice. The aim of this study was to evaluate perioperative outcomes of octogenarians and to identify factors associated with mortality and major complications after open surgical repair (OSR) or endovascular aneurysm repair (EVAR) of a rAAA using nationwide, real-world, contemporary data. METHODS: All patients that underwent EVAR or OSR of an infrarenal or juxtarenal rAAA between January 1, 2013, and December 31, 2018, were prospectively registered in the Dutch Surgical Aneurysm Audit (DSAA) and included in this study. The primary outcome was the comparison of perioperative outcomes of octogenarians versus non-octogenarians, including adjustment for confounders. Secondary outcomes were the identification of factors associated with mortality and major complications in octogenarians. RESULTS: The study included 2879 patients, of which 1146 were treated by EVAR (382 octogenarians, 33%) and 1733 were treated by OSR (410 octogenarians, 24%). Perioperative mortality of octogenarians following EVAR was 37.2% versus 14.8% in non-octogenarians (adjusted OR=2.9, 95% CI=2.8-3.0) and 50.0% versus 29.4% following OSR (adjusted OR=2.2, 95% CI=2.2-2.3). Major complication rates of octogenarians were 55.4% versus 31.8% in non-octogenarians following EVAR (OR=2.7, 95% CI=2.1-3.4), and 68% versus 49% following OSR (OR=2.2, 95% CI=1.8-2.8). Following EVAR, 30.6% of the octogenarians had an uncomplicated perioperative course (UPC) versus 49.5% in non-octogenarians (OR=0.5, 95% CI=0.4-0.6), while following OSR, UPC rates were 20.7% in octogenarians versus 32.6% in non-octogenarians (OR=0.5, 95% CI=0.4-0.7). Cardiac or pulmonary comorbidity and loss of consciousness were associated with mortality and major complications in octogenarians. Interestingly, female octogenarians had lower mortality rates following EVAR than male octogenarians (adjusted OR=0.7, 95% CI=0.6-0.8). CONCLUSION: Based on this nationwide study with real-world registry data, mortality rates of octogenarians following ruptured AAA-repair were high, especially after OSR. However, a substantial proportion of these octogenarians following OSR and EVAR had an uneventful recovery. Known preoperative factors do influence perioperative outcomes and reflect current treatment practice.

Administrative healthcare data as an addition to the Dutch surgical aneurysm audit to evaluate mid-term reinterventions following abdominal aortic aneurysm repair: A pilot study.

BACKGROUND: The Dutch Surgical Aneurysm Audit (DSAA) is a nationwide mandatory quality registry that evaluates the perioperative outcomes of abdominal aortic aneurysms (AAAs). The DSAA includes perioperative outcomes that occur up to 30 days, but various complications following AAA repair occur after this period. Administrative healthcare data yield the possibility to evaluate later occuring outcomes such as reinterventions, without increasing the registration burden. The aim of this study is to assess the feasibility and the potential benefit of administrative healthcare data to evaluate mid-term reinterventions following intact AAA repair. METHOD: All patients that underwent primary endovascular aneurysm repair (EVAR) or open surgical repair (OSR) for an intact infrarenal AAA between January 2017 and December 2018 were selected from the DSAA. Subsequently, these patients were identified in a database containing reimbursement data. Healthcare activity codes that refer to reinterventions following AAA repair were examined to assess reinterventions within 12 and 15 months following EVAR and OSR. RESULTS: We selected 4043 patients from the DSAA, and 2059 (51%) patients could be identified in the administrative healthcare database. Reintervention rates of 10.4% following EVAR and 9.5% following OSR within 12 months (p = 0.719), and 11.5% following EVAR and 10.8% following OSR within 15 months (p = 0.785) were reported. CONCLUSION: Administrative healthcare data as an addition to the DSAA is potentially beneficial to evaluate mid-term reinterventions following intact AAA repair without increasing the registration burden for clinicians. Further validation is necessary before reliable implementation of this tool is warranted.

Treatment Outcome Trends for Non-Ruptured Abdominal Aortic Aneurysms: A Nationwide Prospective Cohort Study.

OBJECTIVE: The Dutch Surgical Aneurysm Audit (DSAA) initiative was established in 2013 to monitor and improve nationwide outcomes of aortic aneurysm surgery. The objective of this study was to examine whether outcomes of surgery for intact abdominal aortic aneurysms (iAAA) have improved over time. METHODS: Patients who underwent primary repair of an iAAA by standard endovascular (EVAR) or open surgical repair (OSR) between 2014 and 2019 were selected from the DSAA for inclusion. The primary outcome was peri-operative mortality trend per year, stratified by OSR and EVAR. Secondary outcomes were trends per year in major complications, textbook outcome (TbO), and characteristics of treated patients. The trends per year were evaluated and reported in odds ratios per year. RESULTS: In this study, 11 624 patients (74.8%) underwent EVAR and 3 908 patients (25.2%) underwent OSR. For EVAR, after adjustment for confounding factors, there was no improvement in peri-operative mortality (aOR [adjusted odds ratio] 1.06, 95% CI 0.94 - 1.20), while major complications decreased (2014: 10.1%, 2019: 7.0%; aOR 0.91, 95% CI 0.88 - 0.95) and the TbO rate increased (2014: 68.1%, 2019: 80.9%; aOR 1.13, 95% CI 1.10 - 1.16). For OSR, the peri-operative mortality decreased (2014: 6.1%, 2019: 4.6%; aOR 0.89, 95% CI 0.82 - 0.98), as well as major complications (2014: 28.6%, 2019: 23.3%; aOR 0.95, 95% CI 0.91 - 0.99). Furthermore, the proportion of TbO increased (2014: 49.1%, 2019: 58.3%; aOR 1.05, 95% CI 1.01 - 1.10). In both the EVAR and OSR group, the proportion of patients with cardiac comorbidity increased. CONCLUSION: Since the establishment of this nationwide quality improvement initiative (DSAA), all outcomes of iAAA repair following EVAR and OSR have improved, except for peri-operative mortality following EVAR which remained unchanged.

One-year results of the INSIGHT study on endovascular treatment of abdominal aortic aneurysms.

OBJECTIVE: Endovascular repair of abdominal aortic aneurysms (AAAs) using the INCRAFT AAA Stent Graft System was safe and effective in regulatory approval studies. We herein report on the 1-year results of a real-world clinical study. METHODS: The INSIGHT study is a multi-center, prospective, open label, post-approval study conducted to continually evaluate the safety and performance of the INCRAFT System. Between 2015 and 2016, 150 consecutive patients with AAA at 23 centers in Europe were treated with the device in routine clinical practice. The primary endpoint was freedom from major adverse events (MAEs), namely death, myocardial infarction, cerebrovascular accident, and renal failure, within 30 days of the index procedure. End point data were assessed by a core laboratory. The secondary end points included technical success at the conclusion of the procedure and clinical success. RESULTS: All 150 patients studied (mean age, 73.6 ± 8.0 years; 89.3% men) met the primary end point without MAEs at 30-day follow-up. Technical success was achieved in 99.3% of patients without stent fractures at 30 days. Among the 146 patients eligible for 1-year follow-up, the MAE rate was 8.2% (ie, 12 patients suffered 13 MAEs: cerebrovascular accident in 8, myocardial infarction in 1, and 4 died, resulting in a 2.7% all-cause mortality rate). There were no reports of new onset renal failure requiring dialysis. Only 2.7% of patients had type I endoleak, and no type III endoleaks were identified through 1 year. The rate of clinical success at 1 year was 91.8%. CONCLUSIONS: The 1-year results of this multicenter real-world study underscore the safety and effectiveness of endovascular treatment of AAA with the INCRAFT System in routine clinical practice.

Clinical Relevance of Closed-Incision Negative Pressure Therapy (ciNPT) for SSI-Risk Reduction in Vascular Surgery Through a Groin Incision.

BACKGROUND: Vascular surgery, especially lower limb revascularization surgery, has one of the highest rates of surgical complications, predominantly surgical site infections (SSI). Resulting in a significant burden of additional costs due to longer hospital stays, re-admissions and re-interventions, mainly attributable to deep incisional SSIs. Closed incisional negative pressure therapy (ciNPT) is a relatively new strategy in the postoperative management surgical wounds, aiming to reduce surgical wound complications. When discussing the clinical relevance of ciNPT, it is crucial to take into account the outcome of therapy as well as the additional costs related to ciNPT. Since, the additional costs must be justified by an associated decrease in the morbidity and costs associated with groin wound complications, which are particularly attributable to deep incisional SSIs. The current literature evaluating the beneficial effect of ciNPT in groin incisional vascular surgery, predominantly focusses on the decrease in superficial SSIs. Whereas this study aims to address and discuss the clinical relevance of ciNPT over conventional wound dressings, by separately evaluating and comparing the incidence of superficial and deep SSIs and their related re-admissions and re-interventions. METHODS: In this single center prospective cohort study performed in a non-academic hospital in The Netherlands, 59 consecutive patients (67 incisions) were included between January and October 2019. All underwent elective vascular surgery with groin (access) incisions for either lower limb revascularization surgery or abdominal aortic aneurysm surgery. The study group was treated with six days ciNPT (PREVENA Incision Management System; KCI/3M, San Antonio, TX, USA) and matched for equal comparison to a historical retrospectively analysed cohort of 54 consecutive patients (60 incisions), all of whom have undergone elective vascular surgery for equal indications with groin (access) incisions in our center between January and October 2018. The standard-care group was treated following standard surgical wound care protocol with conventional surgical self-adhesive plaster (10 × 15cm, Mepore, Mölnlycke Health Care AB, Gothenburg, Sweden). RESULTS: Study groups were comparable at baseline, except for Body Mass Index (BMI), which was significantly higher in the ciNPT-group (P =.021). No significant differences for formation of seroma, hematoma, as well as wound dehiscence and SSIs were found between both groups. Groin SSIs were seen in 12.1% of the patients in the ciNPT-group and in 13.0% in the Standard-care group (OR 0.80, CI ((0.26, 2.48)), deep SSI contributed for 4 out of 7 patients of total SSIs in the ciNPT-group and for 2 out of 7 patients in the standard of care group (P-value >0.05). Analysis for incidence of hospital re-admission and re-intervention in both study groups showed no significant difference. Subset analysis in both study groups for SSIs differentiated in superficial and deep SSIs showed that only deep SSIs resulted in re-interventions. CONCLUSIONS: Based on the findings in the population of our single center study, we conclude that routine use of ciNPT was not effective in reducing groin wound complications, and therefore could not replicate the promising findings from some previous studies. Furthermore, we did not find a reduction in the incidence of deep SSIs, which comprise the highest morbidity and costs. Considering our findings as well as the associated additional expenses related to ciNPT, it might be superfluous at this stage to use ciNPT as the new standard of post-operative groin incision care for all lower limb revascularization and abdominal aortic aneurysm surgeries. In our opinion further research is warranted for establishing a risk-factor based model for determination of the indication of ciNPT. To be able to achieve a more substantiated decision for utilizing ciNPT compared to standard surgical wound care in groin incisional vascular surgical interventions.

Thirty-day Results from the ZEPHYR Registry: Outcomes of EVAR Using the Zenith Alpha™ Abdominal Endovascular Graft for the Treatment of AAA in 347 Patients.

BACKGROUND: To report technical and clinical 30-day results following treatment with the Zenith Alpha™ abdominal stent graft from the ZEnith alPHa for aneurYsm Repair Registry (ZEPHYR). METHODS: Multicenter, nonrandomized, single arm, core laboratory-controlled, prospective registry collecting data on the Zenith Alpha Abdominal Endovascular Graft being used in subjects with abdominal aortic aneurysms (AAA) from sites in Germany, Belgium, and The Netherlands between December 2016 and December 2019. Inclusion criteria were non-ruptured AAAs with a maximum diameter ≥50 mm or enlargement >5 mm over 6 months with an AAA neck length ≥10 mm (site reported). Primary outcome measure was treatment success at 30 days. Treatment success was defined as a combined endpoint consisting of technical and clinical success. Technical success was defined as successful stent graft delivery and deployment as well as successful removal of the delivery system. Clinical success at 30 days was defined as freedom from type I and III endoleak, aneurysm rupture, conversion to open surgery and stent graft occlusion. RESULTS: Three hundred forty-seven subjects were included from 14 sites with a median age of 73.0 years (IQR 68.0-79.0). Thirty-four patients were female (9.8%). The median AAA diameter was 58.3 mm (IQR 55.0-63.5). The median proximal neck diameter was 23.6 mm (IQR 22.0-25.2) with a median proximal neck length of 24.4 mm (IQR 15.0-34.8) and a median infrarenal neck angulation of 24.5° (IQR 15.0-35.0). The right and left common iliac diameter were 16.1 mm (IQR 14.1-19.4) and 16.2 mm (IQR 14.1-19.1), respectively. The treatment success rate at 30 days was 94.8% (N = 329). Technical success was achieved in 333 patients (96.0%). The clinical success rate at 30 days was 98.8% (N = 343). Three patients had limb occlusions at 30 day follow up (0.9%). One patient had a type Ib endoleak (0.3%). Seventy percent of vascular access approaches were percutaneous. The reintervention rate was 1.7% (N = 6) within 30 days. Indications for reinterventions were a false aneurysm at puncture site (N = 1), limb complications (N = 2), stentgraft-associated renal artery occlusions (N = 2), and an external iliac artery thrombosis (N = 1). CONCLUSIONS: Endovascular aneurysm repair using the Zenith Alpha Abdominal Endovascular Graft is effective in the short term. Long term results will be reported in the future.

Long-term Follow-up of a Randomized Clinical Trial Comparing Endovascular Revascularization Plus Supervised Exercise With Supervised Exercise Only for Intermittent Claudication.

OBJECTIVE: The goal of this study was to assess the long-term effectiveness of combination therapy for intermittent claudication, compared with supervised exercise only. BACKGROUND: Supervised exercise therapy is recommended as first-line treatment for intermittent claudication by recent guidelines. Combining endovascular revascularization plus supervised exercise shows promising results; however, there is a lack of long-term follow-up. METHODS: The ERASE study is a multicenter randomized clinical trial, including patients between May 2010 and February 2013 with intermittent claudication. Interventions were combination of endovascular revascularization plus supervised exercise (n = 106) or supervised exercise only (n = 106). Primary endpoint was the difference in maximum walking distance at long-term follow-up. Secondary endpoints included differences in pain-free walking distance, ankle-brachial index, quality of life, progression to critical limb ischemia, and revascularization procedures during follow-up. This randomized trial report is based on a post hoc analysis of extended follow-up beyond that of the initial trial. Patients were followed up until 31 July 2017. Data were analyzed according to the intention-to-treat principle. RESULTS: Median long-term follow-up was 5.4 years (IQR 4.9-5.7). Treadmill test was completed for 128/212 (60%) patients. Whereas the difference in maximum walking distance significantly favored combination therapy at 1-year follow-up, the difference at 5-year follow-up was no longer significant (53 m; 99% CI-225 to 331; P = 0.62). No difference in pain-free walking distance, ankle-brachial index, and quality of life was found during long-term follow-up. We found that supervised exercise was associated with an increased hazard of a revascularization procedure during follow-up (HR 2.50; 99% CI 1.27-4.90; P < 0.001). The total number of revascularization procedures (including randomized treatment) was lower in the exercise only group compared to that in the combination therapy group (65 vs 149). CONCLUSIONS: Long-term follow up after combination therapy versus supervised exercise only, demonstrated no significant difference in walking distance or quality of life between the treatment groups. Combination therapy resulted in a lower number of revascularization procedures during follow-up but a higher total number of revascularizations including the randomized treatment. TRIAL REGISTRATION: Netherlands Trial Registry Identifier: NTR2249.

Association of Hospital Volume with Perioperative Mortality of Endovascular Repair of Complex Aortic Aneurysms: A Nationwide Cohort Study.

OBJECTIVE: We evaluate nationwide perioperative outcomes of complex EVAR and assess the volume-outcome association of complex EVAR. SUMMARY OF BACKGROUND DATA: Endovascular treatment with fenestrated (FEVAR) or branched (BEVAR) endografts is progressively used for excluding complex aortic aneurysms (complex AAs). It is unclear if a volume-outcome association exists in endovascular treatment of complex AAs (complex EVAR). METHODS: All patients prospectively registered in the Dutch Surgical Aneurysm Audit who underwent complex EVAR (FEVAR or BEVAR) between January 2016 and January 2020 were included. The effect of annual hospital volume on perioperative mortality was examined using multivariable logistic regression analyses. Patients were stratified into quartiles based on annual hospital volume to determine hospital volume categories. RESULTS: We included 694 patients (539 FEVAR patients, 155 BEVAR patients). Perioperative mortality following FEVAR was 4.5% and 5.2% following BEVAR. Postoperative complication rates were 30.1% and 48.7%, respectively. The first quartile hospitals performed <9 procedures/yr; second, third, and fourth quartile hospitals performed 9-12, 13-22, and ≥23 procedures/yr. The highest volume hospitals treated the significantly more complex patients. Perioperative mortality of complex EVAR was 9.1% in hospitals with a volume of < 9, and 2.5% in hospitals with a volume of ≥13 (P = 0.008). After adjustment for confounders, an annual volume of ≥13 was associated with less perioperative mortality compared to hospitals with a volume of < 9. CONCLUSIONS: Data from this nationwide mandatory quality registry shows a significant effect of hospital volume on perioperative mortality following complex EVAR, with high volume complex EVAR centers demonstrating lower mortality rates.

Endovascular Revascularization Plus Supervised Exercise Versus Supervised Exercise Only for Intermittent Claudication: A Cost-Effectiveness Analysis.

[Figure: see text].

Wall Shear Stress Assessment of the False Lumen in Acute Type B Aortic Dissection Visualized by 4-Dimensional Flow Magnetic Resonance Imaging: An Ex-Vivo Study.

BACKGROUND: Four-dimensional flow magnetic resonance imaging (4D flow MRI) can accurately visualize and quantify flow and provide hemodynamic information such as wall shear stress (WSS). This imaging technique can be used to obtain more insight in the hemodynamic changes during cardiac cycle in the true and false lumen of uncomplicated acute Type B Aortic Dissection (TBAD). Gaining more insight of these forces in the false lumen in uncomplicated TBAD during optimal medical treatment, might result in prediction of adverse outcomes. METHODS: A porcine aorta dissection model with an artificial dissection was positioned in a validated ex-vivo circulatory system with physiological pulsatile flow. 4D flow MR images with 3 set heartrates (HR; 60 bpm, 80 bpm and 100 bpm) were acquired. False lumen volume per cycle (FLV), mean and peak systolic WSS were determined from 4D flow MRI data. For validation, the experiment was repeated with a second porcine aorta dissection model. RESULTS: During both experiments an increase in FLV (initial experiment: ΔFLV = 2.05 ml, p < 0.001, repeated experiment: ΔFLV = 1.08 ml, p = 0.005) and peak WSS (initial experiment: ΔWSS = 1.2 Pa, p = 0.004, repeated experiment: ΔWSS = 1.79 Pa, p = 0.016) was observed when HR increased from 60 to 80 bpm. Raising the HR from 80 to 100 bpm, no significant increase in FLV (p = 0.073, p = 0.139) was seen during both experiments. The false lumen mean WSS increased significant during initial (2.71 to 3.85 Pa; p = 0.013) and non-significant during repeated experiment (3.22 to 4.00 Pa; p = 0.320). CONCLUSION: 4D flow MRI provides insight into hemodynamic dimensions including WSS. Our ex-vivo experiments showed that an increase in HR from 60 to 80 bpm resulted in a significant increase of FLV and WSS of the false lumen. We suggest that strict heart rate control is of major importance to reduce the mean and peak WSS in uncomplicated acute TBAD. Because of the limitations of an ex-vivo study, 4D flow MRI will have to be performed in clinical setting to determine whether this imaging model would be of value to predict the course of uncomplicated TBAD.

Outcomes in Octogenarians and the Effect of Comorbidities After Intact Abdominal Aortic Aneurysm Repair in the Netherlands: A Nationwide Cohort Study.

OBJECTIVE: Age is an independent risk factor for mortality after both elective open surgical repair (OSR) and endovascular aneurysm repair (EVAR). As a result of an ageing population, and the less invasive nature of EVAR, the number of patients over 80 years (octogenarians) being treated is increasing. The mortality and morbidity following aneurysm surgery are increased for octogenarians. However, the mortality for octogenarians who have either low or high peri-operative risks remains unclear. The aim of this study was to provide peri-operative outcomes of octogenarians vs. non-octogenarians after OSR and EVAR for intact aneurysms, including separate subanalyses for elective and urgent intact repair, based on a nationwide cohort. Furthermore, the influence of comorbidities on peri-operative mortality was examined. METHODS: All patients registered in the Dutch Surgical Aneurysm Audit (DSAA) undergoing intact AAA repair between 2013 and 2018, were included. Patient characteristics and peri-operative outcomes (peri-operative mortality, and major complications) of octogenarians vs. non-octogenarians for both OSR and EVAR were compared using descriptive statistics. Multivariable logistic regression analyses were used to examine whether age and the presence of cardiac, pulmonary, or renal comorbidities were associated with mortality. RESULTS: This study included 12 054 EVAR patients (3 015 octogenarians), and 3 815 OSR patients (425 octogenarians). Octogenarians in both the EVAR and OSR treatment groups were more often female and had more comorbidities. In both treatment groups, octogenarians had significantly higher mortality rates following intact repair as well as higher major complication rates. Mortality rates of octogenarians were 1.9% after EVAR and 11.8% after OSR. Age ≥ 80 and presence of cardiac, pulmonary, and renal comorbidities were associated with mortality after EVAR and OSR. CONCLUSION: Because of the high peri-operative mortality rates of octogenarians, awareness of the presence of comorbidities is essential in the decision making process before offering aneurysm repair to this cohort, especially when OSR is considered.

10-Year Paclitaxel Dose-Related Outcomes of Drug-Eluting Stents Treated Below the Knee in Patients with Chronic Limb-Threatening Ischemia (The PADI Trial).

PURPOSE: Recently, two meta-analyses concluded that there appears to be an increased risk of long-term mortality of paclitaxel-coated balloons and stents in the superficial femoral and popliteal artery, and paclitaxel-coated balloons below the knee. In this post hoc study of the PADI Trial, we investigated the long-term safety of first-generation paclitaxel-coated drug-eluting stents (DES) below the knee and the dose-mortality relationships of paclitaxel in patients with chronic limb-threatening ischemia (CLI). MATERIALS AND METHODS: The PADI Trial compared paclitaxel-coated DES with percutaneous transluminal angioplasty with bail-out bare-metal stents (PTA ± BMS) in patients with CLI treated below the knee. Follow-up was extended to 10 years after the first inclusion, and survival analyses were performed. In addition, dose-related mortality and dose per patient weight-related mortality relations were examined. RESULTS: A total of 140 limbs in 137 patients were included in the PADI Trial. Ten years after the first inclusion, 109/137 (79.6%) patients had died. There was no significant difference between mortality in the DES group compared with the PTA ± BMS group (Log-rank p value = 0.12). No specific dose-related mortality (HR 1.00, 95% CI 0.99-1.00, p = 0.99) or dose per weight mortality (HR 1.05, 95% CI 0.93-1.18, p = 0.46) relationships were identified in the Cox-proportional Hazard models or by Kaplan-Meier survival analyses. CONCLUSIONS: There is a poor 10-year survival in both paclitaxel-coated DES and PTA ± BMS in patients with CLI treated below the knee. No dose-related adverse effects of paclitaxel-coated DES were observed in our study of patients with CLI treated below the knee. LEVEL OF EVIDENCE: The PADI Trial: level 1, randomized clinical trial.

The Influence of Aortic Wall Elasticity on the False Lumen in Aortic Dissection: An In Vitro Study.

BACKGROUND: Hemodynamics, dissection morphology, and aortic wall elasticity have a major influence on the pressure in the false lumen. In contrast to aortic wall elasticity, the influence of hemodynamics and dissection morphology have been investigated often in multiple in vitro and ex vivo studies. The purpose of this study was to evaluate the influence of aortic wall elasticity on the diameter and pressure of the false lumen in aortic dissection. METHODS: An artificial dissection was created in 3 ex vivo porcine aortas. The aorta models were consecutively positioned in a validated in vitro circulatory system with physiological pulsatile flow. Each model was imaged with ultrasound on 4 positions along the aorta and the dissection. At these 4 locations, pressure measurement was also performed in the true and false lumen with an arterial catheter. After baseline experiments, the aortic wall elasticity was adjusted with silicon and the experiments were repeated. RESULTS: The aortic wall elasticity was decreased in all 3 models after siliconizing. In all 3 siliconized models, the diameters of the true and false lumen increased at proximal, mid, and distal location, while the mean arterial pressure did not significantly change. CONCLUSIONS: In this in vitro study, we showed that aortic wall elasticity is an important parameter altering the false lumen. An aortic wall with reduced elasticity results in an increased false lumen diameter in the mid and distal part of the false lumen. These results can only be transferred to corresponding clinical situations to a limited extent.

Chimney Technique to Preserve Visceral Flow in a Coral Reef Aorta.

The coral reef aorta (CRA) is a rare phenomenon of extreme calcification in the juxtarenal and suprarenal aorta. Open revascularization has an overall in-hospital mortality rate of 13%. We present a patient with a suprarenal CRA with colon ischemia. She has an extensive past medical history of percutaneous transluminal angioplasty and stenting of the celiac trunk (CT) and superior mesenteric artery (SMA). The computed tomography angiography showed a CRA of the suprarenal aorta with occlusion of the CT stent and near occlusion of the SMA stent. Our case illustrates that the CRA in the suprarenal part of the aorta can be treated well by chimney graft procedure, although owing to lack of long-term follow-up, it might be reserved for high-risk candidates for (thoraco)abdominal aortic surgery.

Nationwide study of the treatment of mycotic abdominal aortic aneurysms comparing open and endovascular repair in The Netherlands.

OBJECTIVE: Mycotic aneurysms of the abdominal aorta (MAAA) can be treated by open repair (OR) or endovascular aneurysm repair (EVAR). This nationwide study provides an overview of the situation of MAAA treatment in The Netherlands in 2016. METHODS: A retrospective cohort study was conducted with all centers that registered aortic abdominal aneurysms in the Dutch Surgical Aneurysm Audit in 2016. Questionnaires on 1-year outcomes were sent to all centers that treated patients with MAAA. The primary aim was to determine 30-day and 1-year mortality and morbidity of OR- and EVAR-treated patients. Morbidity was determined by the need for reoperations and the number of readmissions to the hospital. RESULTS: Twenty-six MAAA were detected in the Dutch Surgical Aneurysm Audit database of 2016, resulting in an incidence of 0.7% of all registered abdominal aortic aneurysms. The 30-day mortality for OR and EVAR treated patients was 1 in 13 and 0 in 13, respectively. Major and minor reinterventions within 30 days were needed for two (one OR and one EVAR) and two (one OR and one EVAR) patients, respectively. Two patients (15.4%) in the OR group and one patient (7.7%) in the EVAR group were readmitted to hospital within 30 days. In total, 1-year outcomes of 23 patients were available. In the OR group, one patient (9.1%) died in the first postoperative year. There was one major reintervention (removal of endoprosthesis and spiralvein reconstruction) in the EVAR group. Two patients (18.2%) treated with OR and two (16.7%) treated with EVAR required a minor reintervention. In both groups, four patients (OR, 36.4%; EVAR, 33.3%) were readmitted to hospital within 1 year postoperatively. CONCLUSIONS: Both OR- and EVAR-treated patients show acceptable clinical outcomes after 30 days and at the 1-year follow-up. Depending on the clinical course of the patient, EVAR may be considered in the management of this disease.