Cost-effectiveness of Elective Endovascular Aneurysm Repair Versus Open Surgical Repair of Abdominal Aortic Aneurysms.

OBJECTIVE/BACKGROUND: The aim of this study was to estimate the lifetime cost-effectiveness of endovascular aneurysm repair (EVAR) versus open surgical repair (OSR) in the Netherlands, based on recently published literature. METHODS: A model was developed to simulate a cohort of individuals (age 72 years, 87% men) with an abdominal aortic aneurysm (AAA) diameter of at least 5.5 cm and considered fit for both repairs. The model consisted of two sub-models that estimated the lifetime cost-effectiveness of EVAR versus OSR: (1) a decision tree for the first 30 post-operative days; and (2) a Markov model for the period thereafter (31 days-30 years). RESULTS: In the base case analysis, EVAR was slightly more effective (4.704 vs. 4.669 quality adjusted life years) and less expensive (€24,483 vs. €25,595) than OSR. Improved effectiveness occurs because EVAR can reduce 30 day mortality risk, as well as the risk of events following the procedure, while lower costs are primarily due to a reduction in length of hospital stay. The cost-effectiveness of EVAR is highly dependent on the price of the EVAR device and the reduction in hospital stay, complications, and 30 day mortality. CONCLUSION: EVAR and OSR can be considered equally effective, while EVAR can be cost saving compared with OSR. EVAR can therefore be considered as a cost-effective solution for patients with AAAs.

Five-year results of a randomized clinical trial of conventional surgery, endovenous laser ablation and ultrasound-guided foam sclerotherapy in patients with great saphenous varicose veins.

BACKGROUND: A variety of techniques exist for the treatment of patients with great saphenous vein (GSV) varicosities. Few data exist on the long-term outcomes of these interventions. METHODS: Patients undergoing conventional surgery, endovenous laser ablation (EVLA) and ultrasound-guided foam sclerotherapy (UGFS) for GSV varicose veins were followed up for 5 years. Primary outcome was obliteration or absence of the treated GSV segment; secondary outcomes were absence of GSV reflux, and change in Chronic Venous Insufficiency quality-of-life Questionnaire (CIVIQ) and EuroQol - 5D (EQ-5D™) scores. RESULTS: A total of 224 legs were included (69 conventional surgery, 78 EVLA, 77 UGFS), 193 (86.2 per cent) of which were evaluated at final follow-up. At 5 years, Kaplan-Meier estimates of obliteration or absence of the GSV were 85 (95 per cent c.i. 75 to 92), 77 (66 to 86) and 23 (14 to 33) per cent in the conventional surgery, EVLA and UGFS groups respectively. Absence of above-knee GSV reflux was found in 85 (73 to 92), 82 (72 to 90) and 41 (30 to 53) per cent respectively. CIVIQ scores deteriorated over time in patients in the UGFS group (0.98 increase per year, 95 per cent c.i. 0.16 to 1.79), and were significantly worse than those in the EVLA group (-0.44 decrease per year, 95 per cent c.i. -1.22 to 0.35) (P = 0.013). CIVIQ scores for the conventional surgery group did not differ from those in the EVLA and UGFS groups (0.44 increase per year, 95 per cent c.i. -0.41 to 1.29). EQ-5D™ scores improved equally in all groups. CONCLUSION: EVLA and conventional surgery were more effective than UGFS in obliterating the GSV 5 years after intervention. UGFS was associated with substantial rates of GSV reflux and inferior CIVIQ scores compared with EVLA and conventional surgery. REGISTRATION NUMBER: NCT00529672 (http://www.clinicaltrials.gov).

Beneficial Effects of Pre-operative Exercise Therapy in Patients with an Abdominal Aortic Aneurysm: A Systematic Review.

OBJECTIVE/BACKGROUND: The impact of post-operative complications in abdominal aortic aneurysm (AAA) surgery is substantial, and increases with age and concomitant co-morbidities. This systematic review focuses on the possible effects of pre-operative exercise therapy (PET) in patients with AAA on post-operative complications,aerobic capacity, physical fitness, and recovery. METHODS: A systematic search on PET prior to AAA surgery was conducted. The methodological quality of the included studies was rated using the Physiotherapy Evidence Database scale. The agreement between the reviewers was assessed with Cohen's kappa. RESULTS: Five studies were included, with a methodological quality ranging from moderate to good. Cohen's kappa was 0.79. Three studies focused on patients with an AAA (without indication for surgical repair) with physical fitness as the outcome measure. One study focused on PET in patients awaiting AAA surgery and one study focused on the effects of PET on post-operative complications, length of stay, and recovery. CONCLUSION: PET has beneficial effects on various physical fitness variables of patients with an AAA. Whether this leads to less complications or faster recovery remains unclear. In view of the large impact of post-operative complications, it is valuable to explore the possible benefits of a PET program in AAA surgery.

Editor's choice--Use of disposable radiation-absorbing surgical drapes results in significant dose reduction during EVAR procedures.

OBJECTIVES: Because of the increasing number of interventional endovascular procedures with fluoroscopy and the corresponding high annual dose for interventionalists, additional dose-protecting measures are desirable. The purpose of this study was to evaluate the effect of disposable radiation-absorbing surgical drapes in reducing scatter radiation exposure for interventionalists and supporting staff during an endovascular aneurysm repair (EVAR) procedure. MATERIALS: This was a randomized control trial in which 36 EVAR procedures were randomized between execution with and without disposable radiation-absorbing surgical drapes (Radpad: Worldwide Innovations & Technologies, Inc., Kansas City, US, type 5511A). Dosimetric measurements were performed on the interventionalist (hand and chest) and theatre nurse (chest) with and without the use of the drapes to obtain the dose reduction and effect on the annual dose caused by the drapes. RESULTS: Use of disposable radiation-absorbing surgical drapes resulted in dose reductions of 49%, 55%, and 48%, respectively, measured on the hand and chest of the interventionalist and the chest of the theatre nurse. CONCLUSIONS: The use of disposable radiation-absorbing surgical drapes significantly reduces scatter radiation exposure for both the interventionalist and the supporting staff during EVAR procedures.

No differences in perioperative outcome between symptomatic and asymptomatic AAAs after EVAR: an analysis from the ENGAGE Registry.

AIM: This study aimed to compare the differences in perioperative outcome after endovascular repair of symptomatic abdominal aneurysms (S-AAAs) and elective non-symptomatic AAAs (E-AAAs). Data from the ENGAGE Registry were used for the analysis. METHODS: Between March 2009 and December 2010, 1200 AAA patients were enrolled from 79 sites in 30 countries and treated with an Endurant Stent Graft. S-AAAs defined as AAAs accompanied by abdominal or back pain, without rupture, were present in 185 (15.4%) patients and E-AAAs in 1015 (84.6%) patients. Multivariate logistic regression was used to compare results. RESULTS: At baseline, E-AAA patients had larger aneurysms on average (P = 0.006) and scored higher ASA classification more often (P = 0.001). Further analyses were corrected for baseline differences. Operation time and technical success were comparable, and S-AAAs were admitted to the Intensive Care Unit (ICU) as often as E-AAAs (35.7% vs. 33.4%, P = 0.479). Post-operative hospitalisation was similar (4.83 ± 5.29 in E-AAAs and 4.37 ± 3.49 in S-AAAs, P = 0.360). No differences in the occurrence of major adverse events, including mortality, within the 30-day post-implantation were seen between S-AAA and E-AAA patients, respectively, 3.2% and 4.2% (P = 0.572). CONCLUSION: With contemporary devices and technical proficiency, there is no difference in outcome between symptomatic AAA and elective non-symptomatic AAA patients if treated with endovascular techniques.

Vascular complications of Q-fever infections.

INTRODUCTION: Coxiella burnetii is a strict intracellular pathogen causing Q fever, a worldwide zoonosis with an extensive animal reservoir. Chronic Q fever infections are frequently associated with cardiovascular complications, mainly endocarditis, and also aortic aneurysms and vascular-graft infection. We present four cases of chronic Q fever infections and associated vascular complications, and review the literature to identify major symptoms and assess the prevalence, treatment and outcome in these challenging patients. MATERIALS AND METHODS: The demographic and clinical data of four patients presenting at our unit were analysed. PubMed was searched to identify articles describing patients with chronic Q-fever-associated vascular complications. RESULTS: Combining our own with the published experience, 58 cases (49 male) of chronic Q-fever-associated vascular complications were identified. The average age of the patients was 64 years (range: 30-83 years). As many as 26 patients had vascular graft infections (25 Dacron/polytetrafluoroethylene (PTFE), one homograft) and 32 had infected aneurysms. The majority of these patients presented with fever (n = 40) and/or pain (n = 43). Weight loss and fatigue were seen in 25 and 14 patients, respectively. Aneurysm rupture, aorto-enteric fistulae and lower-limb embolisation were seen in nine, four and four patients, respectively. Concurrent endocarditis was seen in two patients, whereas, for 15 cases, this information was not available. Patients were treated with antibiotics for an average of 23 months (range 1-54 months). Treatment of infected vascular segments was described in 50 patients. Ten patients were treated conservatively whilst 40 underwent resection of the infected vessel and reconstruction with a graft. Major surgical complications (graft infection, n = 3;aorto-enteric fistula, n = 2; bleeding, n = 1; anastomotic leakage, n = 1; aortic dissection, n = 1; vertebral osteomyelitis, n = 3; graft thrombosis, n = 1; renal failure, n = 2; and pneumonia, n = 1) were reported in 11 cases (21%) and were not specified in 13. The overall mortality was 24% (14/58). Seven (18%) surgically treated patients died. Six of them died within 6 months of surgery and one patient at 3 years' follow-up. Seven out of 10 of the conservatively treated patients died within 3 years of diagnosis. CONCLUSION: Aneurysms associated with Q-fever infections tend to be complicated, requiring challenging surgical corrections, and long-term antibiotic treatment. Major complications and mortality rates are significant, especially in conservatively treated patients.

Endovascular abdominal aortic aneurysm repair in women.

The objective of this review is to establish the role of endovascular aortic aneurysm repair (EVAR) in women. A step by step approach is taken looking at sex and gender differences in epidemiology, pathogenesis and natural history. We then proceed to discuss the results from the three randomized controlled trials comparing EVAR to open repair. Finally, sex-specific secondary prevention, risk factor management and medication, is discussed. Women seem to have higher mortality and more complications after EVAR. Risk factors such as diabetes and hypertension are associated with worse outcome in women compared to men. The role of EVAR in women is poorly investigated and its definite role remains to be determined. Aggressive treatment of risk factors and the optimisation of medication in women are indicated and deserve more attention in clinical practice and future research.

Contrast-enhanced magnetic resonance angiography findings prior to hemodialysis vascular access creation: a prospective analysis.

PURPOSE: To determine prospectively the clinical value of contrast-enhanced magnetic resonance angiography (CE-MRA) for assessment of the arterial inflow and venous outflow prior to vascular access (VA) creation. METHODS: Seventy-three patients underwent duplex ultrasonography (DUS) and CE-MRA prior to VA creation for detection of stenoses and occlusions. Two observers read the CE-MRA images for determination of inter-observer agreement. A VA was considered functional if it could be used for successful two-needle hemodialysis therapy within 2 months after creation. RESULTS: CE-MRA detected 6 stenosed, 8 occluded arterial vessel segments and 12 stenosed and 41 occluded venous vessel segments in 70 patients. Inter-observer agreement for detection of upper extremity arterial and venous stenoses and occlusions with CE-MRA was substantial to almost perfect (kappa values 0.76-0.96). CE-MRA detected lesions, not detected by DUS, that were associated with VA early failure and non-maturation in 33% of patients (7/21). Accessory veins detected preoperatively were the cause of VA non-maturation in a substantial group of patients (47%: 7/15). CONCLUSION: CE-MRA enables accurate detection of upper extremity arterial and venous stenosis and occlusions prior to VA creation. Preoperative CE-MRA identified arterial and venous stenoses, not detected by DUS that were associated with VA early failure and non-maturation. However, the use of gadolinium containing contrast media is currently contraindicated due the reported incidence of nephrogenic systemic fibrosis.

[Peripheral artery disease: clinical and cost comparison between duplex ultrasonography and contrast-enhanced magnetic resonance angiography--a multicenter randomized trial]. / De kosten en de effecten van magnetischeresonantieangiografie en duplexechografie bij patiënten met perifeer arterieel vaatlijden: een multicentrische gerandomiseerde studie.

OBJECTIVE: To determine the clinical and economic consequences of replacing duplex ultrasonography (DUS) by contrast-enhanced magnetic resonance angiography (CE-MRA) for the initial diagnostic work-up of patients with peripheral artery disease (PAD). DESIGN: Randomised multicentre study. METHOD: In the period from January 2002 to August 2003, consecutive patients with PAD were randomly assigned to CE-MRA or DUS. The primary outcome measure was the costs. Secondary outcome measures included the confidence with which the specialist could take a therapeutic decision on the basis of the imaging study, the change in disease severity, and the change in quality of life (QOL) assessed during 6 months of follow-up. In addition, all costs of imaging, therapeutic interventions and outpatient visits were calculated. RESULTS: After 6 months of follow-up the data on 352 patients were analysed. Use of CE-MRA reduced the number of additional vascular-imaging procedures by 42% ((69-40)/69) and the specialists felt more confident about their therapeutic decisions. The diagnostic costs of all imaging studies taken together were Euro 167,- higher, on average, in the CE-MRA group (p < 0.001). However, after 6 months of follow-up, no statistically significant differences were found between the two groups with regard to the change in disease severity, the QOL, or the total costs (p > 0.05). CONCLUSION: Based on these findings, a specialist that replaces DUS by CE-MRA will feel more confident about taking a therapeutic decision and will feel less need for additional imaging. However, the diagnostic costs were higher with CE-MRA.

Does endovascular aortic aneurysm repair justify a reduced cardiology work-up?

Endovascular repair of abdominal aortic aneurysms (EVAR) has been introduced as an alternative to open surgery with the purpose of reducing operative risk and improving survival. Since cardiac co-morbidity is a major risk factor for both the operative procedure and long-term survival, it seems worthwhile to compare the cardiac implication of the 2 procedures. If EVAR would indeed afford a cardioprotective effect, this could have clinical consequences. Preoperative cardiology work-up could be reduced and more high-risk patients could be treated. A review of the literature has been made focusing on studies that examined cardiology work-up and cardiac risk profile of EVAR and open surgery. Most literature data suggest that cardiac risk is indeed reduced with EVAR, since hemodynamic alterations are less severe, episodes of anaemia are less frequent, plasma catecholamine levels are lower and general anaesthesia can be avoided. There is no level I or II evidence that immediate or late cardiac complications are indeed reduced with EVAR. At present, there are not enough literature data on the cardiac implications of EVAR to justify a reduced preoperative cardiology work-up. Even if conclusive evidence was available that EVAR reduces operative cardiac risk, the value of preoperative cardiac screening and myocardial revascularisation would remain unchanged: the purpose of cardiology work-up is not only to reduce operative risk but also to improve long-term survival.

Transaxillary first rib resection for thoracic outlet syndrome.

Surgical therapy of thoracic outlet syndrome (T.O.S.) is highly controversial. In contrast to many large series, recent literature reports a moderate to poor outcome following surgery. The aim of the present study is to evaluate the efficacy of transaxillary first rib resection in the treatment of T.O.S. Over the past twelve years 106 first rib resections were performed on 92 patients. Neurological complaints predominate (63%), while arterial and venous symptoms account for 22 and 15% of the symptoms respectively. Preoperative screening consisted of a thorough interview and clinical examination, chest and spine X-ray, duplex-ultrasonography, angiography on indication, E.M.G. and a neurologist's consultation. Standard treatment was transaxillary first rib resection as described by Roos and Owens. Eighty-five patients (92%) attended a follow-up examination with a mean follow-up of 63.2 months. All patients were examined by an independent observer and the resumption of pre-illness activity was recorded. Only 52% of the operations turned out to be successful. All other procedures resulted in identical or worse complaints than before surgery. In contrast to many other series and in accordance with some recent critical series we conclude that first rib resection is often not effective in relieving T.O.S. A renewed focus on conservative treatment seems justified with surgery serving as a very last resort.

Systematic approach to ruptured abdominal aortic aneurysm in the endovascular era: Intention-to-treat eEVAR protocol.

Emergency endovascular aneurysm repair (eEVAR) for ruptured abdominal aortic aneurysms (rAAA) is still a relatively new treatment option. A pre-defined strategy of an eEVAR first approach for rAAA is associated with improved mortality rates. After establishing and implementing the Intention-to-treat eEVAR protocol for rAAAs the mortality and morbidity rates improved significantly. The presented Intention-to-treat eEVAR protocol starts at the first telephone call to the ambulance department and lasts until the post-operative care unit. The protocol involves the close collaboration between the ambulance department, vascular surgeon, emergency department physicians, anaesthesiologists, operating room staff and, radiology technicians. The availability of a variety of off-the-shelf stent-grafts, and an operating room that is adequately equipped to perform endovascular procedures is crucial in obtaining better outcomes. High volume centres that offer open surgical repair as well as eEVAR for rAAA show that the Intention-to-treat eEVAR protocol is achievable and appears to be associated with favorable mortality over open repair with appropriate case selection. Unstable or older patients with rAAA may particularly benefit by eEVAR.

Which factors increase the risk of conversion to open surgery following endovascular abdominal aortic aneurysm repair? The EUROSTAR collaborators.

OBJECTIVE: to identify factors that increase the risk of conversion to open surgery following endovascular repair of abdominal aortic aneurysms (AAAs) and to assess their outcome. Design analysis of 1871 patients enrolled in the EUROSTAR collaborators registry. MATERIALS AND METHODS: patient characteristics, anatomic features of the aneurysm, type of endovascular device, institutional experience and the year in which the procedure was performed were related to risk of conversion. RESULTS: forty-nine patients (2.6%) required conversion. In 38 patients conversion was performed during the first postoperative month (primary conversions) and in 11 patients during follow-up (secondary conversions). Primary conversion was mostly due to access problems and device migration. Secondary conversions were performed for rupture in six and for a persistent endoleak, with or without aneurysmal growth, in five patients. Patients who were converted were significantly older, had a lower body weight, and had a higher prevalence of chronic obstructive pulmonary disease. Conversion was associated with shorter, wider infrarenal necks and larger aneurysms. The conversion rate was lower when a team had performed more than 30 procedures, and in procedures performed during the last two years of the study period. The conversion rate was higher with EVT or Talent devices. Patients who required primary conversion had an 18% mortality rate, compared to 2.5% mortality in patients without conversion (p<0.01). Secondary conversion was associated with a perioperative mortality of 27%, and when performed for rupture 50%. CONCLUSION: both primary conversion and secondary conversion for rupture carry a high operative mortality. Awareness of the risk factors may reduce conversion rate as well as early and medium term mortality.

Cardiac response and complications during endovascular repair of abdominal aortic aneurysms: a concurrent comparison with open surgery.

PURPOSE: The purpose of this study was to assess and to compare perioperative changes in left ventricular function and the incidence of adverse cardiac events in two groups of patients with abdominal aortic aneurysms, one during endovascular aneurysm repair (EAR) and the other during open aneurysm repair (OAR). METHODS: One hundred twenty consecutive patients who underwent EAR (49 patients) or OAR (71 patients) were prospectively studied. During the operation, the left ventricular function was assessed by the recording of the left ventricle stroke work index (SWI) and the cardiac index (CI) with a pulmonary artery catheter. Measurements were performed before, during, and after stent-graft deployment or aortic cross-clamping. Both maneuvers were defined as aortic occlusion (AO). Transesophageal echocardiography was performed to identify signs of wall motion abnormalities of the left ventricular wall, which indicated myocardial ischemia. Six-lead electrocardiograph monitoring was maintained until discharge from the intensive care unit. Postoperative cardiac complications were diagnosed by clinical observation, 12-lead ECG analysis at 1, 3, and 7 days after the operation, transthoracic echocardiography at 1 month, and measurement of cardiac enzymes. RESULTS: The two study groups were comparable with regard to most clinical aspects. The baseline myocardial performance was worse in patients who underwent EAR compared with patients who underwent OAR, as indicated by a reduced SWI (33.1 and 37.4, respectively; P =.03). During AO there was a comparable increase of the CI in both groups. However, after AO the rise in CI was higher in patients who underwent OAR compared with patients who underwent EAR (0.7 and 0.2, respectively; P <.01), representing a more pronounced hyperdynamic state. In addition, the SWI demonstrated a decrease in patients who underwent OAR compared with an increase in patients who underwent EAR during AO (-1.4 and +1.9, respectively; P =.04) and after AO (-0.9 and +2.6, respectively; P =.01). These findings represent more severe myocardial stress in patients who underwent OAR. The incidence of postoperative clinical cardiac adverse events was comparable in the two study groups. However, myocardial ischemia, as indicated by electrocardiography and transesophageal echocardiography, had a higher incidence in patients who underwent open surgery as compared with patients whose condition was managed endovascularly (57% and 33%, respectively; P =.01). CONCLUSION: Hemodynamic alterations during endovascular repair were not as severe as those in patients with open surgery and indicated less myocardial stress in the former category. These findings may explain a lower incidence of myocardial ischemia that was observed during endovascular repair. A lower frequency of clinical perioperative cardiac events in patients undergoing endovascular treatment may ultimately be expected.

Randomized study comparing cardiac response in endovascular and open abdominal aortic aneurysm repair.

BACKGROUND: The aim was to compare the cardiac response and the incidence of adverse cardiac events during and after endovascular (EVAR) and open (OR) repair of abdominal aortic aneurysms (AAAs). METHODS: Seventy-six patients with an AAA suitable for EVAR, and in a general condition allowing open surgery were randomized to EVAR (57 patients) or OR (19 patients). The analysis was on an intention-to-treat basis. Haemodynamic variables were assessed intraoperatively before, during and after aortic occlusion. During the procedure myocardial ischaemia was identified with use of electrocardiography (ECG) and transoesophageal echocardiography (TEE). After operation, cardiac complications were diagnosed by clinical observation, 12-lead ECG at 1 h, 1 day and 7 days, echocardiography at 1 month and measurement of cardiac enzymes. RESULTS: After aortic occlusion, a greater decrease in systemic vascular resistance compared with baseline was observed with OR than with EVAR (- 396 and - 70 dyne s/cm5 respectively; P = 0.03). The stroke work index, as a direct measure of myocardial performance, demonstrated a decrease during OR and an increase during EVAR during aortic occlusion (- 6.6 and + 1.7 g m/m2 respectively; P = 0.03) as well as after aortic occlusion (- 7.6 and + 3.4 g m/m2 respectively; P < 0.01), compared with baseline. The incidence of postoperative clinical cardiac complications was comparable in the two study groups; however, myocardial ischaemia, as observed by ECG and TEE, was observed more frequently in the OR group (ten of 19 versus 15 of 57 patients; P = 0.05). CONCLUSION: Haemodynamic changes were less severe and there was a lower incidence of myocardial ischaemia during EVAR than during OR. Studies are needed to demonstrate whether this may reduce the operative mortality rate.