Treatment of aortic aneurysms registered in Swedvasc: Development reflected in a national vascular registry with an almost 100% coverage.

Swedvasc is a registry for vascular surgical procedures, both open and endovascular. It was started in 1987 and since 1994 the whole population of Sweden is covered, at present around 10 million inhabitants. In a recent external validation, it was found to be highly accurate with abdominal aortic aneurysm surgery correctly reported in >96%. In this paper various factors explaining the almost 100% coverage are discussed, one important being that the registry has been developed and maintained within the profession of vascular surgery and not dictated by authorities. Another factor of importance is the possibility to use data in various research projects and so far 15 PhD theses have used Swedvasc data. To exemplify the practical use of the registry, the treatment of abdominal aortic aneurysms is scrutinized and among the various complications abdominal compartment syndrome is analyzed. Several significant temporal changes have been observed over the almost 25 years of Swedvasc: increasing use of endovascular surgery, treatment of aneurysms detected by screening , decreasing treatment for rupture, improved outcome, increasing treatment of older patients and patients with comorbid conditions. In conclusion, a high quality national vascular registry can be valid with high compliance and can be used to study population-based development of treatment and outcome. It can also be used to perform international comparisons with other registries, thereby getting an indication of the quality of care.

Editor's Choice - Management of Secondary Aorto-enteric and Other Abdominal Arterio-enteric Fistulas: A Review and Pooled Data Analysis.

OBJECTIVES: To compare management strategies for secondary abdominal arterio-enteric fistulas (AEFs). METHODS: This study is a review and pooled data analysis. Medline and Scopus databases were searched for studies published between 1999 and 2015. Particular emphasis was given to short- and long-term outcomes in relation to AEF repair type. RESULTS: Two hundred and sixteen publications were retrieved, reporting on 823 patients. In-hospital mortality was 30.7%. Open surgery had higher in-hospital mortality (246/725, 33.9%), than endovascular methods (7/98, 7.1%, p < .001, OR 6.7, 95% CI 3-14.7, including staged endovascular to open surgery, 0/13, 0%). In-hospital mortality after graft removal/extra-anatomical bypass grafting was 31.2% (66/226), graft removal/in situ repair 34% (137/403), primary closure of the arterial defect 62.5% (10/16), and for miscellaneous open procedures 41.3% (33/80), p = .019. Among the subgroups of in situ repair, homografts were associated with a higher mortality than impregnated prosthetic grafts (p = .047). There was no difference in recurrent AEF-free rates between open and endovascular procedures. Extra-anatomical bypass/graft removal and in situ repair had a lower AEF recurrence rate than primary closure and homografts. Late sepsis occurred more often after endovascular surgery (2-year rates 42% vs. 19% for open, p = .001). The early survival benefit of endovascular surgery was blunted during follow-up, although it remained significant (p < .001). Within the in situ repair group, impregnated prosthetic grafts were associated with the worst overall and AEF related mortality free rates and vein grafts with the best. No recurrence, sepsis, or mortality was reported following staged endograft placement to open repair after a mean follow-up of 16.8 months (p = .18, p = .22, and p = .006, respectively, compared with patients in other groups). CONCLUSIONS: Endovascular surgery, where appropriate, is associated with better early survival than open surgery for secondary AEFs. Most of this benefit is lost during long-term follow-up, implying that a staged approach with early conversion to in situ vein grafting may achieve the best results in selected patients.

Treatment of venous thromboembolism in cancer patients with dalteparin for up to 12 months: the DALTECAN Study.

BACKGROUND: Treatment of venous thromboembolism (VTE) in patients with cancer has a high rate of recurrence and bleeding complications. Guidelines recommend low-molecular-weight heparin (LMWH) for at least 3-6 months and possibly indefinitely for patients with active malignancy. There are, however, few data supporting treatment with LMWH beyond 6 months. The primary aim of the DALTECAN study (NCT00942968) was to determine the safety of dalteparin between 6 and 12 months in cancer-associated VTE. METHODS: Patients with active cancer and newly diagnosed VTE were enrolled in a prospective, multicenter study and received subcutaneous dalteparin for 12 months. The rates of bleeding and recurrent VTE were evaluated at months 1, 2-6 and 7-12. FINDINGS: Of 334 patients enrolled, 185 and 109 completed 6 and 12 months of therapy; 49.1% had deep vein thrombosis (DVT); 38.9% had pulmonary embolism (PE); and 12.0% had both on presentation. The overall frequency of major bleeding was 10.2% (34/334). Major bleeding occurred in 3.6% (12/334) in the first month, and 1.1% (14/1237) and 0.7% (8/1086) per patient-month during months 2-6 and 7-12, respectively. Recurrent VTE occurred in 11.1% (37/334); the incidence rate was 5.7% (19/334) for month 1, 3.4% (10/296) during months 2-6, and 4.1% (8/194) during months 7-12. One hundred and sixteen patients died, four due to recurrent VTE and two due to bleeding. CONCLUSION: Major bleeding was less frequent during dalteparin therapy beyond 6 months. The risk of developing major bleeding complications or VTE recurrence was greatest in the first month of therapy and lower over the subsequent 11 months.

Iatrogenic vascular injuries with lethal outcome.

BACKGROUND: The aim was to study the nature of iatrogenic vascular injuries (IVIs) associated with postoperative death within 30 days. METHODS: Patients who had undergone vascular surgery for IVIs and were reported prospectively to the Swedish national vascular registry during 1987-2008 were identified. They were cross-checked with the national population registry. Those who died within 30 days of surgery were studied regarding case records and death certificates. RESULTS: A total of 56 patients with postoperative death within 30 days after IVI were identified. Among them, 52 case records were retrieved (93 %). In 24 cases the IVIs were caused by puncture during endovascular procedures (13 hemorrhage, 11 occlusive thrombosis), 11 by penetrating trauma during open surgery, 6 by occlusion after external compression, 6 by percutaneous accidental arterial puncture. Main symptoms were peripheral ischemia (19/52, 37 %), external bleeding (14, 27 %), and hypovolemic shock without external bleeding (10, 19 %). Main specialties involved were interventional radiology (n = 18), general surgery (n = 9), and interventional cardiology (n = 8). Overall, 22 (42 %) were avoidable, and only 13 (25 %) underwent autopsy. Within 2 weeks, 36 patients (69 %) were dead. Also, there was a higher proportion with uncertain correlation between IVI and death. CONCLUSIONS: Interventional radiology, general surgery, and cardiology are the main specialities involved in IVIs with lethal outcome. Not all fatalities after IVI are attributable to the injury itself, but almost half of the injuries were considered avoidable.

Vascular injuries caused by acupuncture. A systematic review.

AIM: The aim of the study was to systematically review the literature on vascular injuries caused by acupuncture. METHODS: This was a systematic literature search in Medline and PubMed. RESULTS: Thirty-one cases were identified and the majority developed symptoms in direct connection with the acupuncture treatment. Three patients died, two from pericardial tamponade and one from an aortoduodenal fistula. There were seven more tamponades, eight pseudoaneurysms, two with ischemia, two with venous thrombosis, one with compartment syndrome and seven with bleeding (five in the central nervous system). The two patients with ischemia had remaining sequeleae. Information on follow-up was suboptimal with no information in fourteen patients. CONCLUSION: Vascular injuries are rare, bleeding and pseudoaneurysm dominating. Follow-up is insufficient in the hitherto published papers.

Abdominal aortic aneurysm and new WHO criteria for screening.

Does screening of abdominal aortic aneurysm (AAA) fulfil the recently revised the World Health Organization WHO criteria for screening? Contemporary data from the literature are used to analyze whether the ten recent WHO criteria can be used to motivate AAA screening. Although the prevalence of AAA seems to decrease, at least screening of 65-year old males saves lives and is cost-effective. Ultrasonographic screening for AAA in risk populations fulfils the new WHO criteria for screening.

Prevention and treatment of venous thromboembolism--International Consensus Statement.

The aim of this document is to provide a clear and concise account of the evidence regarding efficacy or harm for various methods available to prevent and manage venous thromboembolism (VTE).

Health technology assessment in surgery.

This review focuses on how surgical methods should be assessed from a health technology perspective. The use of randomized controlled trials, population based registries, systematic literature research and the recently published IDEAL method are briefly discussed.

Treatment of haemophilia A and B and von Willebrand's disease: summary and conclusions of a systematic review as part of a Swedish health-technology assessment.

In an ongoing health-technology assessment of haemophilia treatment in Sweden, performed by the governmental agency Dental and Pharmaceutical Benefits Agency (TLV; tandvårds-och lakemedelsförmånsverket), the Swedish Council on Health Technology Assessment (SBU; statens beredning för medicinsk utvardering) was called upon to evaluate treatment of haemophilia A and B and von Willebrand's disease (VWD) with clotting factor concentrates. To evaluate the following questions: What are the short-term and long-term effects of different treatment strategies? What methods are available to treat haemophilia patients that have developed inhibitors against factor concentrates? Based on the questions addressed by the project, a systematic database search was conducted in PubMed, NHSEED, Cochrane Library, EMBASE and other relevant databases. The literature search covered all studies in the field published from 1985 up to the spring of 2010. In most instances, the scientific evidence is insufficient for the questions raised in the review. Concentrates of coagulation factors have good haemostatic effects on acute bleeding and surgical intervention in haemophilia A and B and VWD, but conclusions cannot be drawn about possible differences in the effects of different dosing strategies for acute bleeding and surgery. Prophylaxis initiated at a young age can prevent future joint damage in persons with haemophilia. The available treatment options for inhibitors have been insufficiently assessed. The economic consequences of various treatment regimens have been insufficiently analysed. Introduction of national and international registries is important.

Insurance claims after vascular surgery in Sweden.

OBJECTIVES: The study aimed to estimate the incidence and causes of insurance claims (IC) after vascular surgery (VS) reported to the Swedish Medical Injury Insurance (SMII); and to validate the registration of complications in the National Vascular Registry (Swedvasc). METHODS: The medical records of all IC in VS in Sweden reported to the SMII 2002-2007 were scrutinised and cross-referenced against Swedvasc. RESULTS: There were 193 claims after VS: varicose-veins (66), lower extremity (45), aortic (31) or carotid artery (21), access (19) or other VS (11). Frequent causes of claims were peripheral nerve injury (76), wound infection (22) and cranial nerve injury (15). More than half of the patients suffered permanent injuries, three died. As many as 55 (28%) received economic compensation (an average of 45% of all ICs in SMII). The highest frequency of compensated claims (1:650 yearly procedures) was for carotid artery surgery. Of the procedures, 187 were elective. Compared with the Swedvasc, claudication was a more common indication (28% vs. 12%). Nearly one-fifth (18%) were incorrectly registered in Swedvasc. CONCLUSIONS: The most common causes of insurance claims were peripheral nerve injuries and infections. Patients raising insurance claims after vascular surgery undergo acute procedures less frequently, and are correctly registered in the Swedvasc in 82% of cases.

Late follow-up of a randomized trial of routine duplex imaging before varicose vein surgery.

BACKGROUND: Routine preoperative duplex examination led to an improvement in results 2 years after surgery for primary varicose veins. The aim of the present study was to evaluate the impact of preoperative duplex imaging after 7 years, in relation to other risk factors for varicose vein recurrence. METHODS: Patients with primary varicose veins were randomized to operation with (group 1), or without (group 2) preoperative duplex imaging. The same patients were invited to attend follow-up with interview, clinical examination and duplex imaging. Quality of life (QoL) was measured with the Short Form 36 questionnaire. RESULTS: Some 293 patients (343 legs) were included initially; after 7 years 227 were interviewed, or their records reviewed: 114 in group 1 and 113 in group 2. One hundred and ninety-four legs (95 in group 1 and 99 in group 2) were examined clinically and with duplex imaging. Incompetence was seen at the saphenofemoral junction and/or saphenopopliteal junction in 14 per cent of legs in group 1 and 46 per cent in group 2 (P < 0.001). QoL was similar in both groups. After a mean follow-up of 7 years (and including patients who underwent surgery after the review), 15 legs in group 1 needed reoperation and 38 in group 2 (P = 0.001). CONCLUSION: Routine preoperative duplex imaging improved the results of surgery for primary varicose veins for at least 7 years.

Pharmacological interventions to attenuate the expansion of abdominal aortic aneurysm (AAA) - a systematic review.

INTRODUCTION: Is it possible by pharmacological methods to attenuate the expansion rate of abdominal aortic aneurysms? METHOD: An Internet-based systematic literature search was performed to identify published reports on pharmacological methods to influence aneurysmal expansion rate. RESULTS: Of an original 450 articles, 21 remained to review: they included 15 cohort studies with 12,321 patients and seven randomised clinical trials (RCTs) with 1069 patients. Most studies are performed without a pre-study sample size calculation. There is no consistent pattern of pharmacological influence on expansion rate, but statins, non-steroidal anti-inflammatory drugs (NSAIDs) and macrolides should be further evaluated. CONCLUSION: Properly designed RCTs are needed before conclusions can be drawn on the possibility to pharmacologically attenuate aneurysmal expansion and prevent rupture.

Results of the randomized, placebo-controlled clopidogrel and acetylsalicylic acid in bypass surgery for peripheral arterial disease (CASPAR) trial.

OBJECTIVE: Dual antiplatelet therapy with clopidogrel plus acetylsalicylic acid (ASA) is superior to ASA alone in patients with acute coronary syndromes and in those undergoing percutaneous coronary intervention. We sought to determine whether clopidogrel plus ASA conferred benefit on limb outcomes over ASA alone in patients undergoing below-knee bypass grafting. METHODS: Patients undergoing unilateral, below-knee bypass graft for atherosclerotic peripheral arterial disease (PAD) were enrolled 2 to 4 days after surgery and were randomly assigned to clopidogrel 75 mg/day plus ASA 75 to 100 mg/day or placebo plus ASA 75 to 100 mg/day for 6 to 24 months. The primary efficacy endpoint was a composite of index-graft occlusion or revascularization, above-ankle amputation of the affected limb, or death. The primary safety endpoint was severe bleeding (Global Utilization of Streptokinase and Tissue plasminogen activator for Occluded coronary arteries [GUSTO] classification). RESULTS: In the overall population, the primary endpoint occurred in 149 of 425 patients in the clopidogrel group vs 151 of 426 patients in the placebo (plus ASA) group (hazard ratio [HR], 0.98; 95% confidence interval [CI], 0.78-1.23). In a prespecified subgroup analysis, the primary endpoint was significantly reduced by clopidogrel in prosthetic graft patients (HR, 0.65; 95% CI, 0.45-0.95; P = .025) but not in venous graft patients (HR, 1.25; 95% CI, 0.94-1.67, not significant [NS]). A significant statistical interaction between treatment effect and graft type was observed (P(interaction) = .008). Although total bleeds were more frequent with clopidogrel, there was no significant difference between the rates of severe bleeding in the clopidogrel and placebo (plus ASA) groups (2.1% vs 1.2%). CONCLUSION: The combination of clopidogrel plus ASA did not improve limb or systemic outcomes in the overall population of PAD patients requiring below-knee bypass grafting. Subgroup analysis suggests that clopidogrel plus ASA confers benefit in patients receiving prosthetic grafts without significantly increasing major bleeding risk.

A critical appraisal of bleeding events reported in venous thromboembolism prevention trials of patients undergoing hip and knee arthroplasty.

BACKGROUND: Anticoagulants are effective for the prevention of venous thromboembolism (VTE) but cause bleeding. Interpretation of the risks and benefits of new anticoagulant regimens for VTE prevention is complicated by a lack of standardized definitions and reporting of bleeding. We reviewed the reporting of bleeding in randomized controlled trials of new anticoagulants compared with standard doses of enoxaparin in hip and knee arthroplasty, and examined the possible impact of differences in the definition of major bleeding on interpretation of the trial results. METHODS: Electronic searches identified 16 phase III trials published between 2001 and 2010 involving 41,265 patients comparing one of five new anticoagulants with a common comparator, enoxaparin. RESULTS: Major bleeding rates in patients treated with enoxaparin ranged from 0.1% to 3.1% in hip arthroplasty trials and from 0.2% to 1.4% in knee arthroplasty trials. In studies that excluded surgical-site bleeding from the definition, major bleeding rates were about 10-fold lower than in those which included surgical-site bleeding. Within the individual trials, the choice of bleeding definition and the methods of assessment of bleeding influenced the conclusions regarding the risk of bleeding with new anticoagulant regimens relative to enoxaparin. Eight of the 16 studies demonstrated a ≥ 40% relative risk differences in major bleeding between treatment groups but the difference was statistically significant in only two of these trials. CONCLUSION: Randomized VTE prevention trials report markedly different rates of major bleeding despite similar patient populations and doses and durations of anticoagulant prophylaxis and were underpowered to detect modest differences in patient-important bleeding events. Standardization of bleeding definitions and reporting seems desirable.

Validation of the Simulator for Testing and Rating Endovascular SkillS (STRESS)-machine in a setting of competence testing.

AIM: Endovascular skills are an integral part of modern-day vascular surgery. The STRESS machine has been developed to test these skills in vascular surgeons. This study aims to define an optimal pass/fail cutoff value for the STRESS test score. METHODS: The STRESS machine consists of a dry glass model of the abdominal aorta and its tributaries with various stenotic lesions, elongations, and tortuosities. A camera and computer software are used to simulate plain fluoroscopy-mode. The test subjects are given two assignments after which two reviewers use a combination of the ICEPS and MRS to produce the final total score; 43 subjects were tested. According to previous endovascular experience, subjects were classified into four groups: novice-low (no experience, less than 11 performed procedures, less than 50 assisted procedures), novice-high (11-25 performed procedures, more than 50 assisted procedures), intermediate (1-10 performed and >11-25 assisted procedures, 11-25 performed and >1-10 assisted procedures or 25-50 performed procedures) and advanced (more than 50 performed procedures). RESULTS: Test-score and noted experience showed a correlation of 0.794. All intermediate and advanced test subjects scored more than 50 points compared to 4 out of 15 novices. CONCLUSION: We demonstrated that it is possible to determine an optimal cut-off value for competence testing with the STRESS machine.

Definition of major bleeding in clinical investigations of antihemostatic medicinal products in surgical patients.

The definition of major bleeding varies between studies on surgical patients, particularly regarding the criteria for surgical wound-related bleeding. This diversity contributes to the difficulties in comparing data between trials. The Scientific and Standardization Committee (SSC), through its subcommittee on Control of Anticoagulation, of the International Society on Thrombosis and Haemostasis has previously published a recommendation for a harmonized definition of major bleeding in non-surgical studies. That definition has been adopted by the European Medicines Agency and is currently used in several non-surgical trials. A preliminary proposal for a parallel definition for surgical studies was presented at the 54(th) Annual Meeting of the SSC in Vienna, July 2008. Based on those discussions and further consultations with European and North American surgeons with experience from clinical trials a definition has been developed that should be applicable to all agents that interfere with hemostasis. The definition and the text that follows have been reviewed and approved by relevant co-chairs of the subcommittee and by the Executive Committee of the SSC. The intention is to seek approval of this definition from the regulatory authorities to enhance its incorporation into future clinical trial protocols.