Eversion technique versus traditional carotid endarterectomy with patch angioplasty: a systematic review with meta-analyses and trial sequential analysis.

Introduction: The use of an 'eversion' technique is not unequivocally proven to be superior to carotid endarterectomy with patch angioplasty. An up-to-date systematic review is needed for evaluation of benefits and harms of these two techniques. Methods: RCTs comparing eversion technique versus endarterectomy with patch angioplasty in patients with a symptomatic and significant (≥50 %) stenosis of the internal carotid artery were enrolled. Primary outcomes were all-cause mortality rate, health-related quality of life and serious adverse events. Secondary outcomes included 30-day stroke and mortality rate, (a) symptomatic arterial occlusion or restenosis, and adverse events not critical for decision making. Results: Four RCTs were included with 1272 surgical procedures for carotid stenosis; eversion technique n = 643 and carotid endarterectomy with patch closure n = 629. Meta-analysis comparing both techniques showed, with a very low certainty of evidence, that eversion technique might decrease the number of patients with serious adverse events (RR 0.47; 95% CI 0.34 to 0.64; p ≤ 0.01). However, no difference was found on the other outcomes. TSA demonstrated that the required information sizes were far from being reached for these patient-important outcomes. All patient-relevant outcomes were at low certainty of evidence according to GRADE. Conclusions: This systematic review showed no conclusive evidence of any difference between eversion technique and carotid endarterectomy with patch angioplasty in carotid surgery. These conclusions are based on data obtained in trials with very low certainty according to GRADE and should therefore be interpreted cautiously. Until conclusive evidence is obtained, the standard of care according to ESVS guidelines should not be abandoned.

The Effect of Arterial Disease Level on Outcomes of Supervised Exercise Therapy for Intermittent Claudication: A Prospective Cohort Study.

OBJECTIVE: To assess whether level of arterial obstruction determines the effectiveness of SET in patients with IC. BACKGROUND DATA: Guidelines advocate SET before invasive treatment for IC, but early revascularization remains widespread, especially in patients with aortoiliac disease. METHODS: Patients were recruited from 10 Dutch centers between October 2017 and October 2018. Participants received SET first, followed by endovascular or open revascularization in case of insufficient effect. They were grouped according to level of stenosis (aortoiliac, femoropopliteal, multilevel, or rest group with no significant stenosis). Changes from baseline walking performance (maximal and functional walking distance on a treadmill test, 6-minute walk test) and vascular quality of life questionnaire-6 at 3 and 6 months were compared, after multivariate adjustment for possible confounders. Freedom from revascularization was estimated with Kaplan-Meier analysis. RESULTS: Some 267 patients were eligible for analysis (aortoiliac n = 70, 26%; femoropopliteal n = 115, 43%; multilevel n = 69, 26%; rest n = 13, 5%). No between group differences in walking performance or vascular quality of life questionnaire-6 were found. Mean improvement in maximal walking distance after 6 months was 439 m [99% confidence interval (CI) 297-581], 466 m (99% CI 359-574), 353 m (99% CI 210-496), and 403 m (99% CI 58-749), respectively (P = 0.40). Freedom from intervention was 73.9% for aortoiliac disease and 88.6% for femoropopliteal disease (hazard ratio 2.46, 99% CI 0.96 - 6.30, P = 0.013). CONCLUSIONS: Short-term effectiveness of SET for IC is not determined by the location of stenosis. Although aortoiliac disease patients improved walking performance and health-related quality of life similarly compared to other arterial disease level groups, they underwent revascularization more often.

Open Preperitoneal Inguinal Hernia Repair, TREPP Versus TIPP in a Randomized Clinical Trial.

OBJECTIVE: The aim of this study was to compare chronic postoperative inguinal pain (CPIP) in patients with an inguinal hernia after the TransREctus Sheath PrePeritoneal (TREPP) and the TransInguinal PrePeritoneal Technique (TIPP). BACKGROUND: The preperitoneal mesh position for inguinal hernia repair showed beneficial results regarding CPIP with low recurrence rates. Two open preperitoneal techniques, TREPP and TIPP, were compared in a randomized clinical trial with the hypothesis of fewer patients with CPIP after TREPP due to complete avoidance of nerve contact. METHODS: Adult patients with a primary unilateral inguinal hernia were randomized to either TREPP or TIPP in four hospitals. Before the trial's start the study protocol was ethically approved and published. Outcomes included CPIP after 1 year (primary outcome) and recurrence rates, adverse events, and health-related quality of life (secondary outcomes). Follow-up was performed at 2 weeks, 6 months, and 1 year. RESULTS: Baseline characteristics were comparable in both groups. Pain was less often present after TREPP at 2 weeks and 6 months, but CPIP at rest at 1 year was comparable: 1.9% after TREPP vs 1.4% after TIPP, P = 0.535). The overall recurrence rate was higher in the TREPP group, 8.9% vs 4.6%, P = 0.022). Corrected for a learning curve for TREPP, no significant difference could be assessed (TREPP 5.7% and TIPP 4.8%, P = 0.591). CONCLUSION: Both the TREPP and TIPP technique resulted in a low incidence of CPIP after 1-year follow-up. The TREPP method can be considered a solid method for inguinal hernia repair if expertise is present. The learning curve of the TREPP techniques needs further evaluation. TRIAL REGISTRATION: ISRCTN18591339.

Giant true hepatic aneurysm mimicking Mirizzi syndrome.

Giant true aneurysms of the hepatic arteries are rare. Pseudoaneurysms of the hepatic arteries are more common and are mostly caused by intra-abdominal infection, iatrogenic injury, or trauma. Hepatic or cystic pseudoaneurysms are often successfully treated by embolization owing to their saccular nature as opposed to true aneurysms. We present a case of a patient with a giant true aneurysm of the proper hepatic artery, mimicking Mirizzi syndrome. Open reconstruction was successfully preformed, and the patient made a full recovery.

Editor's Choice - A Systemic Evaluation of the Costs of Elective EVAR and Open Abdominal Aortic Aneurysm Repair Implies Cost Equivalence.

OBJECTIVE: The suggested high costs of endovascular aneurysm repair (EVAR) hamper the choice of insurance companies and financial regulators for EVAR as the primary option for elective abdominal aortic aneurysm (AAA) repair. However, arguments used in this debate are impeded by time related aspects such as effect modification and the introduction of confounding by indication, and by asymmetric evaluation of outcomes. Therefore, a re-evaluation minimising the impact of these interferences was considered. METHODS: A comparative analysis was performed evaluating a period of exclusive open repair (OR; 1998-2000) and a period of established EVAR (2010-2012). Data from four hospitals in The Netherlands were collected to estimate resource use. Actual costs were estimated by benchmark cost prices and a literature review. Costs are reported at 2019 prices. A break even approach, defining the costs for an endovascular device at which cost equivalence for EVAR and OR is achieved, was applied to cope with the large variation in endovascular device costs. RESULTS: One hundred and eighty-six patients who underwent elective AAA repair between 1998 and 2000 (OR period) and 195 patients between 2010 and 2012 (EVAR period) were compared. Cost equivalence for OR and EVAR was reached at a break even price for an endovascular device of €13 190. The main cost difference reflected the longer duration of hospital stay (ward and Intensive Care Unit) of OR (€11 644). Re-intervention rates were similar for OR (24.2%) and EVAR (24.6%) (p = .92). CONCLUSION: Cost equivalence for EVAR and OR occurs at a device cost of €13 000 for EVAR. Hence, for most routine repairs, EVAR is not costlier than OR until at least the five year follow up.

A Comparison of Quality of Life in Elderly Patients with Intermittent Claudication and Chronic Limb-Threatening Ischemia.

BACKGROUND: Intermittent claudication (IC) and chronic limb-threatening ischemia (CLTI) are both associated with a decreased health status and possibly quality of life (QOL). A better understanding of the differences in QOL between patients with IC and CLTI could be of additional value in shared decision-making. The aim of this study was to compare the QOL at baseline between patients with IC and patients with CLTI. METHODS: The study population was based on 2 study cohorts, 1 cohort consisted of patients with IC (ELECT registry) and the other cohort of patients with CLTI (KOP-study). Patients with an age of ≥70 years were included. QOL at baseline was measured by the WHOQOL-BREF questionnaire. Nonresponders were excluded from data analyses. Student's t-tests and analysis of covariance (ANCOVA) analyses were used to compare QOL between the 2 groups. Outcomes of the ANCOVA analyses were expressed as estimated marginal means. RESULTS: In total, 308 patients were included, 115 patients with IC and 193 patients with CLTI. Patients with CLTI were older (median age 80 years vs. 75 years, P < 0.001) and had more comorbidities. Patients with IC had a statistically significant higher QOL regarding physical health (mean 13.7 [standard deviation (SD) 2.3] vs. 10.8 [SD 2.8], P < 0.001), psychological health (mean 15.3 [SD 2.1] vs. 14.1 [SD 2.4], P < 0.001), environment (mean 16.3 [SD 2.4] vs. 15.5 [SD 2.0], P < 0.002), and the overall domain (mean 3.5 [SD 0.7] vs. 3.1 [SD 0.9], P < 0.001). After correcting for the confounding effect of age and sex, patients with IC still had a statistically significant higher QOL in the physical, psychological, environment, and overall domain. CONCLUSIONS: Patients with IC had a significantly higher QOL in the physical, psychological, environment, and overall domains of the WHOQOL-BREF questionnaire compared with patients with CLTI. This underlines the importance of strategies that reduce disease progression as disease progression is associated with a decrease in QOL.

Eversion technique versus conventional endarterectomy with patch angioplasty in carotid surgery: protocol for a systematic review with meta-analyses and trial sequential analysis of randomised clinical trials.

INTRODUCTION: Traditional carotid endarterectomy is considered to be the standard technique for prevention of a new stroke in patients with a symptomatic carotid stenosis. Use of patch angioplasty to restore the arterial wall after longitudinal endarterectomy is, to date, not unequivocally proven to be superior to eversion technique. A systematic review is needed for evaluation of benefits and harms of the eversion technique versus the traditional endarterectomy with patch angioplasty in patients with symptomatic carotid stenosis. METHODS AND OUTCOMES: The review will be conducted according to this protocol following the recommendations of the 'Cochrane Handbook for Systematic Reviews' and reported according to Preferred Reporting Items for Systematic Reviews and Meta-Analyses. Randomised clinical trials comparing eversion technique versus endarterectomy with patch angioplasty in patients with a symptomatic stenosis of the internal carotid artery will be included. Primary outcomes are all-cause mortality rate, health-related quality of life and serious adverse events. Secondary outcomes are 30-day stroke and mortality rate, symptomatic arterial restenosis or occlusion and non-serious adverse events. The databases Cochrane Central Register of Controlled Trials, PubMed/MEDLINE and EMBASE will be searched (November 2019). We will primarily base our conclusions on meta-analyses of trials with overall low-risk of bias. We will use trial sequential analysis to assist the evaluation of imprecision in Grading of Recommendations, Assessment, Development and Evaluation. However, if pooled point estimates of all trials are similar to pooled point estimates of trials with overall low risk of bias and there is lack of a statistical significant interaction between estimates from trials with overall high risk of bias and trials with overall low risk of bias we will consider the trial sequential analysis adjusted precision of the estimate achieved in all trials as the result of our meta-analyses. ETHICS AND DISSEMINATION: The proposed systematic review will collect and analyse data from published studies, therefore, ethical approval is not required. The results of the review will be disseminated by publication in a peer-review journal and submitted for presentation at conferences. PROSPERO REGISTRATION NUMBER: CRD42019119361.

Gentamicin Containing Collagen Implants and Groin Wound Infections in Vascular Surgery: A Prospective Randomised Controlled Multicentre Trial.

OBJECTIVE: The aim of this study was to assess the effectiveness of gentamicin containing collagen implants in the reduction of surgical site infections (SSIs) in patients undergoing an inguinal incision for vascular surgery. METHODS: Prospective blinded randomised controlled multicentre trial (RCT), performed in four hospitals in The Netherlands and Belgium. This study included 288 patients who underwent an inguinal incision for primary arterial repair (femoral endarterectomy, femorofemoral or femoropopliteal bypass, aortobifemoral bypass, thrombectomy, embolectomy, endovascular aneurysm repair) between October 2012 and December 2015. Patients were randomised to receive a gentamicin implant (study group) or no implant (control group). The calculated sample sizes of 304 patients per group were not reached. Primary outcome was SSI incidence after six weeks. Secondary outcomes were time to onset of infection, length of hospital stay, allergic reactions, treatment with antibiotics, need for re-admission, re-operation and mortality. RESULTS: One hundred fifty-one patients were allocated to the study group (mean age 69 ± 9.2 years) and 137 patients were allocated to the control group (mean age 70 ± 10.4 years). Both groups were homogeneous regarding baseline and intra-operative characteristics. Gentamicin implants did not result in a significant overall reduction of SSIs in the study group (7% vs. 12%, p = .17). In a post hoc analysis comparing two study sites with low (<10%) and two study sites with high (>10%) infection rates in the control group, gentamicin implants significantly reduced SSIs in high risk centres (22% vs. 1%, p < .001), whereas there was no significant effect in low risk centres (13% vs. 7%, p = .30). There were no allergic reactions and all secondary outcomes were comparable between groups. CONCLUSION: Gentamicin implants did not result in a significant overall reduction of SSIs in this RCT. Gentamicin implants did reduce the incidence of SSIs in high risk centres and may be a valuable adjunct to improve outcomes in such vascular centres with a high incidence of wound infections. However, the limitation of not reaching the calculated sample sizes should be considered.

Eagle Syndrome: A Unique Cause of Carotid Bleeding.

Eagle syndrome is a rare aggregate of symptoms caused by an elongated styloid process. We present the unique case of bilateral vascular Eagle syndrome in a patient who experienced a unilateral acute swelling due to bleeding at the level of the right internal carotid artery. This complication has never been described before. (Level of Difficulty: Advanced.).

Penetrating Neck Injury in Two Dutch Level 1 Trauma Centres: the Non-Existent Problem.

OBJECTIVES: Penetrating neck injuries (PNIs) have a low incidence in European trauma populations. Selective non-operative management of PNI has been suggested as a safe alternative to standard surgical neck exploration, but evidence is lacking. This clinical scenario evaluates institutional PNI management, specifically the associated carotid artery injury, and compares it with current guidelines. METHODS: Retrospectively, PNI patients presenting at two Dutch level 1 trauma centres from 2007 to 2015, were identified. International guidelines on PNI management were reviewed and recommendations were assessed in relation to current institutional management, and considering an illustrative case. RESULTS: Two current guidelines on PNI management were reviewed. Both advocate a zone based approach; one recommends a prominent role for computed tomography angiography (CTA) scanning in stable patients, supplemented by endoscopy when indicated. A combined total of 43 PNI patients were identified over a nine year period. Haemodynamically unstable patients and patients with other hard signs (i.e. active bleeding, expanding haematoma, air/saliva leak, massive subcutaneous emphysema) received immediate exploration (n = 9). Haemodynamically stable patients and those responding to resuscitation (transient responders) had a CTA scan (n = 31). Three asymptomatic patients were treated conservatively, and had an uncomplicated clinical course regarding the PNI. In 10 of 14 patients who received surgical exploration, a significant vascular or aerodigestive injury was found and repaired (71%). All patients treated conservatively after CTA scanning had an uncomplicated clinical course regarding the PNI (n = 17). Six patients with penetrating carotid artery injury underwent primary arterial reconstruction, of whom five survived. CONCLUSIONS: This clinical scenario evaluates institutional management in two trauma centres for PNI and associated carotid artery injury, and compares it to current guidelines. In comparison with guideline recommendations, CTA scanning and the so called "No zone" approach appears to have assumed a more prominent role in management of PNI.

Clinical presentation, diagnosis, and treatment of venous aneurysms.

Venous aneurysms have been reported in most major veins and are often asymptomatic but can cause serious complications. Three patients with symptomatic venous aneurysms of the internal jugular vein, portal vein, and popliteal vein are presented, and their treatment and outcomes are discussed. Furthermore, presentation and management of the most frequent venous aneurysms, based on available literature, are evaluated. The literature supports conservative treatment of asymptomatic and nonthrombotic jugular, subclavian, thoracic, and visceral venous aneurysms. Surgery should be considered only for symptomatic venous aneurysms or in case of progressive expansion on follow-up. Prophylactic surgery is recommended for all patients with lower extremity deep venous aneurysms, by means of tangential aneurysmectomy with lateral venorrhaphy, because of the increased risk of pulmonary embolization. Postoperative anticoagulation is recommended for a period of at least 3 months after operative treatment.

Vascular access outcome in the elderly dialysis patient in combination with the quality of life.

PURPOSE: We performed a retrospective study on hemodialysis fistulae in patients aged 75 years and older. METHODS: Dialysis records of 2 hospitals were searched for patients of 75 years and older who had primary autologous radiocephalic arteriovenous fistulae (RCAVFs) and brachiocephalic arteriovenous fistulae (BCAVFs). Outcome measures were primary, primary-assisted, and secondary patency rates. Also, quality of life (QOL) was measured. RESULTS: A total of 107 fistulae were placed in 90 patients; 65 (61%) RCAVFs and 42 (39%) BCAVFs were created. The primary patency rate (P = .026) and the primary-assisted patency rate (P = .016) of BCAVFs were significantly higher than that of RCAVFs. Secondary patency rates at 1 year (P = .01) and 2 years (P = .035) were higher in BCAVFs than in RCAVFs. CONCLUSIONS: The BCAVFs give significantly higher primary and primary-assisted patency rates and also significantly higher secondary patency rates at 1 and 2 years. Therefore, we suggest the placement of elbow fistulae in the elderly patients. The QOL was surprisingly high in this population despite a high mortality rate.

Study protocol for a randomized controlled trial for anterior inguinal hernia repair: transrectus sheath preperitoneal mesh repair compared to transinguinal preperitoneal procedure.

BACKGROUND: Anterior open treatment of the inguinal hernia with a tension-free mesh has reduced the incidence of hernia recurrence. The Lichtenstein procedure is the current reference technique for inguinal hernia treatment. Chronic pain has become the main postoperative complication after surgical inguinal hernia repair, especially following Lichtenstein. Preliminary experiences with a soft mesh positioned in the preperitoneal space (PPS) by transinguinal preperitoneal (TIPP) or total extraperitoneal (TEP) technique, showed promising results considering the reduction of postoperative chronic pain. Evolution of surgical innovations for inguinal hernia repair led to an open, direct approach with preperitoneal mesh position, such as TIPP. Based on the TIPP procedure, another preperitoneal repair has been recently developed, the transrectus sheath preperitoneal (TREPP) mesh repair. METHODS: The ENTREPPMENT trial is a multicentre randomized clinical trial. Patients will be randomly allocated to anterior inguinal hernia repair according to the TREPP mesh repair or TIPP procedure. All patients with a primary unilateral inguinal hernia, eligible for operation, will be invited to participate in the trial. The primary outcome measure will be the number of patients with postoperative chronic pain. Secondary outcome measures will be serious adverse events (SAEs), including recurrence, hemorrhage, return to daily activities (for example work), operative time and hospital stay. Alongside the trial health status, an economic evaluation will be performed. To demonstrate that inguinal hernia repair according to the TREPP technique reduces the percentage of patients with postoperative chronic pain from 12% to <6%, a sample size of 800 patients is required (two-sided test, α = 0.05, 80% power).The ENTREPPMENT trial aims to evaluate the TREPP and TIPP procedures from patients' perspective. It is hypothesized that the TREPP technique may reduce the number of patients with any form of postoperative chronic pain by 50% compared to the TIPP procedure. TRIAL REGISTRATION: Current Controlled Trials: ISRCTN18591339.

Report of two in situ reconstructions with a saphenous spiral vein graft of Coxiella burnetii-infected aneurysms of the abdominal aorta.

Coxiella burnetii is a rare cause of vascular infections. Yet, Q fever is endemic in the southern part of The Netherlands. This report describes two patients--from the southern part of The Netherlands--with infected aneurysms of the abdominal aorta caused by Coxiella burnetii. Both patients underwent surgical debridement, in situ reconstruction with a great saphenous vein spiral graft, and a transmesenteric omentumplasty. One patient fully recovered, while the other died due to ischemic complications. A multidisciplinary work-up approach to treat infected abdominal aneurysms is proposed, including adequate surgical treatment and long-term antibiotic administration.

Infected abdominal aneurysm due to Salmonella sepsis: report of a unique case treated using the superficial femoral vein.

We describe a 61-year-old patient with an infected aneurysm of the abdominal aorta due to Salmonella sepsis. Treatment was successful and included aneurysm resection, extensive debridement, and reconstruction of the abdominal aorta using the superficial femoral vein, combined with long-term antibiotic therapy.

Anterior preperitoneal repair of extremely large inguinal hernias: An alternative technique.

INTRODUCTION: Standard open anterior inguinal hernia repair is nowadays performed using a soft mesh to prevent recurrence and to minimalize postoperative chronic pain. To further reduce postoperative chronic pain, the use of a preperitoneal placed mesh has been suggested. In extremely large hernias, the lateral side of the mesh can be insufficient to fully embrace the hernial sac. We describe the use of two preperitoneal placed meshes to repair extremely large hernias. This 'Butterfly Technique' has proven to be useful. Hernias were classified according to hernia classification of the European Hernia Society (EHS) during operation. Extremely large indirect hernias were repaired by using two inverted meshes to cover the deep inguinal ring both medial and lateral. Follow up was at least 6 months. VAS pain score was assessed in all patients during follow up. Outcomes of these Butterfly repairs were evaluated. Medical drawings were made to illustrate this technique. A Total of 689 patients underwent anterior hernia repair 2006-2008. PRESENTATION OF CASE: Seven male patients (1%) presented with extremely large hernial sacs. All these patients were men. Mean age 69.9 years (range: 63-76), EHS classifications of hernias were all unilateral. Follow up was at least 6 months. Recurrence did not occur after repair. Chronic pain was not reported. DISCUSSION: Open preperitoneal hernia repair of extremely large hernias has not been described. The seven patients were trated with this technique uneventfully. No chronic pain occurred. CONCLUSION: The Butterfly Technique is an easy and safe alternative in anterior preperitoneal repair of extremely large inguinal hernias.

The Tilburg double blind randomised controlled trial comparing inguinal hernia repair according to Lichtenstein and the transinguinal preperitoneal technique.

BACKGROUND: Anterior open treatment of the inguinal hernia with a tension free mesh has reduced the incidence of recurrence and direct postoperative pain. The Lichtenstein procedure rules nowadays as reference technique for hernia treatment. Not recurrences but chronic pain is the main postoperative complication in inguinal hernia repair after Lichtenstein's technique. Preliminary experiences with a soft mesh placed in the preperitoneal space showed good results and less chronic pain. METHODS: The TULIP is a double-blind randomised controlled trial in which 300 patients will be randomly allocated to anterior inguinal hernia repair according to Lichtenstein or the transinguinal preperitoneal technique with soft mesh. All unilateral primary inguinal hernia patients eligible for operation who meet inclusion criteria will be invited to participate in this trial. The primary endpoint will be direct postoperative- and chronic pain. Secondary endpoints are operation time, postoperative complications, hospital stay, costs, return to daily activities (e.g. work) and recurrence. Both groups will be evaluated.Success rate of hernia repair and complications will be measured as safeguard for quality.To demonstrate that inguinal hernia repair according to the transinguinal preperitoneal (TIPP) technique reduces postoperative pain to <10%, with alpha = 0,05 and power 80%, a total sample size of 300 patients was calculated. DISCUSSION: The TULIP trial is aimed to show a reduction in postoperative chronic pain after anterior hernia repair according to the transinguinal preperitoneal (TIPP) technique, compared to Lichtenstein.In our hypothesis the TIPP technique reduces chronic pain compared to Lichtenstein. TRIAL REGISTRATION: ISRCTN 93798494.