[Insurance claims after vascular surgery]. / Erfarenheter av undvikbara skador vid kärlkirurgi.

Insurance claims after vascular surgery have been analyzed during two three-year periods. Ca 0.6 % of arterial operations and 0.3 % of venous operations have been claimed, 30 % and 40 % respectively having been economically compensated as they were judged avoidable. The increase in endovascular treatments has not influenced the pattern of claims.

The Consequences of Negligence Claims in Arterial Surgery - An Analysis of Two Periods with an Increasing Use of Endovascular Treatment.

OBJECTIVES: Patient treatment within the Swedish medical service system can claim negligence injuries to the malpractice insurance review board and request financial compensation. The aim of this paper was to analyse the consequences of a negligence claim after arterial surgery between two periods with increasing use of endovascular treatment. METHODS: This was a retrospective cohort study of the arterial surgery negligence claims from two three year periods 2005-2007 (Period A) and 2012-2014 (Period B) from the County Council's Mutual Insurance Company. The analysis was restricted to aortic, carotid, and lower limb arterial diseases. The magnitude of surgery for vascular diseases was obtained from the Swedish vascular register (Swedvasc). RESULTS: The number of patients undergoing arterial procedures increased from 16 628 to 20 709 (p = .01). There was an increase of 54% in the number of negligence claims between the periods. In Period A, the number of compensated claims was 22 out of 83 (29%) and in Period B 60 out of 151 (41%) (p = .06). Patients treated for aortic disorders and peripheral arterial surgery received compensation with increasing frequency whereas carotid diseases decreased. Claimants treated for aortic disorders were compensated in four out of 23 (17%) and 21 out of 54 (39%) in the two periods (p = .07), and after lower limb arterial surgery in six out of 34 (18%) and in 24 out of 71 (34%) (p = .09). After carotid surgery the corresponding figures were 12 out of 26 (46%) and 14 out of 25 (46%) (p = .48). The increasing use of endovascular procedures (but not in carotid artery surgery) did not seem to influence the pattern of negligence claims. CONCLUSIONS: Between the two three year periods there has been an increase in negligence claims but not in compensated ones. The increased use of endovascular procedures has not influenced the pattern of compensated negligence claims.

Surgical Renovascular Reconstruction for Renal Artery Stenosis and Aneurysm: Long-Term Durability and Survival.

OBJECTIVE: To study functional outcome, mortality, and dialysis free survival in patients undergoing open primary surgical repair of renal artery stenosis (RAS) or aneurysm (RAA). METHODS: This was a retrospective single centre study of patients undergoing open surgical renal artery reconstruction from 1993 to 2007. Blood pressure, renal function, dialysis dependence, vessel patency, and mortality were registered. Survival was investigated by cross matching with the population registry, yielding up to 20 years of follow up. RESULTS: Of the 40 patients operated on, 25 (63%) were women. RAS was the indication for reconstruction in 31 patients; 23 had atherosclerotic aetiology (ARAS), and eight had fibromuscular dysplasia (FMD). Nine patients had RAA. Patients with ARAS were older (p = .008), had more extensive peripheral arterial disease (p = .004), and inferior renal function (p = .003) compared with patients with FMD or RAA. In FMD and RAA, the right renal artery was affected in 13/17 (76%) cases, whereas in ARAS the disease was evenly distributed. In patients with ARAS, 15/25 (60%) stenotic renal arteries (two bilateral procedures) were managed by aorto-renal bypass, and 2/25 (8%) through ilio-renal bypass. In 8/25 (32%) endarterectomy was performed. In FMD, all but one patient underwent aorto-renal bypass. Early mortality was 2.5% (one patient with ARAS). One patient with ARAS required dialysis post-operatively. Systolic blood pressure was significantly reduced in patients with ARAS, from 180 mmHg (median) pre-operatively to 155 mmHg at one month (p = .003) and 160 mmHg at one year (p = .03). Need for medication decreased from three or more drugs to two drugs at one month (p = .01). In FMD, there was a similar tendency. Three patients underwent re-intervention for restenosis: two endovascularly and one by open surgery. The overall 5 year survival was 88%. Median follow up was 10.6 years. CONCLUSION: Open surgical renal arterial reconstruction was performed with low mortality, fairly low morbidity, and excellent durability. Open surgery should still be considered a therapeutic option in complex renal artery disease.

Successful pregnancies after neonatal aortic thrombosis, childhood arterial repair, and a deficient pelvic vasculature.

Neonatal aortic bifurcation thrombosis can cause occlusion of iliac arteries causing abnormal pelvic vasculature and claudication in childhood. A bifurcation graft normalizes the perfusion of the legs but not of the pelvis. In a girl, this does not preclude successful pregnancies in adult life. It has not been reported before.

Carotid Endarterectomy Induces the Release of Inflammatory Markers and the Activation of Coagulation as Measured in the Jugular Bulb.

BACKGROUND AND PURPOSE: Transient cerebral hypoxia may induce neuronal injury through an ischemia-reperfusion (I/R) response, with a subsequent activation of inflammation and coagulation-fibrinolysis. During carotid endarterectomy (CEA), the artery is clamped, which might impair the regional cerebral perfusion and initiate a local I/R response. Data suggest that the CD40-CD40 ligand dyad acts as a modulator in the induced activation. The aim of this study was to locally measure soluble CD40 ligand (sCD40L), in conjunction with inflammation and coagulation activation markers, during CEA. SUBJECTS AND METHODS: This is a prospective study of 18 patients undergoing CEA. Blood samples from the venous jugular bulb (JB) and the radial artery (RA) were drawn at baseline and during the procedure. Measurements of sCD40L, interleukin-6 (IL-6), fragment 1 + 2 (F1 + 2), plasminogen activator inhibitor-1 (PAI-1), and d-dimer were analyzed. Comparisons during CEA were made between levels: baselines versus JB, JB versus RA, and sequential JB measurements. Fifty cardiovascular healthy patients were the reference group for the sCD40L baseline comparison. RESULTS: Increased cerebral IL-6 levels were demonstrated throughout the procedure, as well as the temporal influence in F1 + 2, PAI-1, and d-dimer values. sCD40L remained unchanged throughout the procedure . This indicates a local cerebral inflammatory reaction together with an activation of coagulation-fibrinolysis, but it does not appear to primarily involve the CD40-CD40 ligand dyad. CONCLUSIONS: Signs of a local inflammatory reaction and activation of coagulation were observed during CEA, but levels of sCD40L remained stable, unaffected by carotid artery clamping and reperfusion.

Validation of the VASCUNET registry - pilot study.

BACKGROUND: VASCUNET is an international registry of vascular surgical (open and endovascular) procedures since 1997. The aim of this paper is to describe a pilot validation performed at three hospitals in Hungary in September 2012. PATIENTS AND METHODS: Three core indications were checked: abdominal aortic aneurysm, carotid artery disease and limb ischemia with infrainguinal treatment. RESULTS: 2439 registered procedures had been reported with between 94 and 109 per cent agreement with hospital administrative numbers. In a random sample of 29 patients the VASCUNET data were compared with the patient records regarding risk factors, procedures performed and in hospital results. Only few discrepancies were found. CONCLUSIONS: The conclusions are that validation is feasible, that this pilot project in Hungary showed good agreement between registry and local patient records. For a registry to be accepted and used both for practical and scientific purposes regular validation by senior surgeons should be undertaken and the vascular surgical community must have a budget for such a process.

Benefit-to-harm ratio of thromboprophylaxis for patients undergoing major orthopaedic surgery. A systematic review.

Surgeons consider the benefit-to-harm ratio when making decisions regarding the use of anticoagulant venous thromboembolism (VTE) prophylaxis. We evaluated the benefit-to-harm ratio of the use of newer anticoagulants as thromboprophylaxis in patients undergoing major orthopaedic surgery using the likelihood of being helped or harmed (LHH), and assessed the effects of variation in the definition of major bleeding on the results. A systematic literature search was performed to identify phase II and phase III studies that compared regulatory authority-approved newer anticoagulants to the low-molecular-weight heparin enoxaparin in patients undergoing major orthopaedic surgery. Analysis of outcomes data estimated the clinical benefit (number-needed-to-treat [NNT] to prevent one symptomatic VTE) and clinical harm (number-needed-to-harm [NNH] or the NNT to cause one major bleeding event) of therapies. We estimated each trial's benefit-to-harm ratio from NNT and NNH values, and expressed this as LHH = (1/NNT)/(1/NNH) = NNH/NNT. Based on reporting of efficacy and safety outcomes, most studies favoured enoxaparin over fondaparinux, and rivaroxaban over enoxaparin. However, when using the LHH metric, most trials favoured enoxaparin over both fondaparinux and rivaroxaban when they included surgical-site bleeding that did not require reoperation in the definition of major bleeding. The exclusion of bleeding at surgical site which did not require reoperation shifted the benefit-to-harm ratio in favour of the newer agents. Variations in the definitions of major bleeding may change the benefit-to-harm ratio and subsequently affect its interpretation. Clinical trials should attempt to improve the consistency of major bleeding reporting.

Treatment of vascular Ehlers-Danlos syndrome: a systematic review.

OBJECTIVE: To provide the collected evidence from all literature reports. BACKGROUND: Vascular Ehlers-Danlos syndrome (EDS) is a rare connective tissue disorder with serious hemorrhagic consequences. Most experience on treatment is based on case reports and small case series. METHOD: A systematic literature review was performed. PubMed and reference lists were scrutinized. RESULTS: A total of 231 patients were identified with no gender preponderance. Aneurysms were present in 40%, often multiple. In 33%, there was an arterial rupture without an underlying aneurysm. Carotidocavernous fistula was seen in 18%. After open surgery the mortality was 30%; after endovascular procedures, it was 24%; in a group of miscellaneous cases, it was 60%; and the overall mortality was 39%. The median age of patients at death was 31 years. The median follow-up time was 12 months (5 days-7 years), but in 20% cases, it was not reported. In only 29 of the 119 recent patients (24%) the mutation was verified with molecular genetic testing. CONCLUSIONS: Vascular EDS is a serious disorder with high mortality, which does not seem to have been influenced by new treatment methods. Invasive methods should be used only when necessary, primarily to save the patients' life. Whenever possible, the genetic molecular defect should be identified. The results of this review may be affected by publications bias. Ideally, a prospective registry should be created.

Low-molecular-weight heparin versus rivaroxaban in orthopedic surgery.

From the ORTHO-TEP registry on joint replacement arthroplasty (hip and knee) from Dresden, Germany, three periods of different prophylactic regimens have been compared. In the present paper, results from low-molecular-weight heparin and rivaroxaban have been analyzed, with rivaroxaban showing a benefit concerning both effect and side effects. Clinical end points are used, the results being in line with published data from randomized studies. Inclusion in the registry of consecutive patients is important to illustrate generalizability of results obtained in randomized trials. This review discusses the problem with using historical comparisons to draw firm conclusions.

Antimicrobial treatment to impair expansion of abdominal aortic aneurysm (AAA): a systematic review of the clinical evidence.

Antimicrobial treatment to attenuate expansion of abdominal aortic aneurysm has been suggested, especially with the focus on Chlamydophila. In this systematic literature review only four randomized trials were identified. In two small studies there is an indication of an effect of roxithromycin. In conclusion, however, more studies are needed, and they must be properly sized based on power calculations as well as antimicrobially relevant. Such trials are on the way both in Europe and the US, the results being awaited with interest.

Evaluation of the duration of thromboembolic prophylaxis after high-risk orthopaedic surgery: the ETHOS observational study.

Real-life data on post-discharge venous thromboembolism (VTE) prophylaxis practices and treatments are lacking. We assessed post-operative VTE prophylaxis prescribed and received in a prospective registry, compared with the 2004 American College of Chest Physicians (ACCP) guidelines in high-risk orthopaedic surgery patients. Consecutive patients undergoing total hip arthroplasty (THA), hip fracture surgery (HFS), or knee arthroplasty (KA) were enrolled at discharge from 161 centres in 17 European countries if they had received in-hospital VTE prophylaxis that was considered in accordance with the ACCP guidelines by the treating physician. Data on prescribed and actual prophylaxis were obtained from hospital charts and patient post-discharge diaries. Post-operative prophylaxis prescribed and actual prophylaxis received were considered adherent or adequate, respectively, if recommended therapies were used for ≥28 days (HFS and THA) or ≥10 days (KA). Among 4,388 patients, 69.9% were prescribed ACCP-adherent VTE prophylaxis (THA: 1,411/2,217 [63.6%]; HFS: 701/1,112 [63.0%]; KA: 955/1,059 [90.2%]). Actual prophylaxis received was described in 3,939 patients with an available diary after discharge (non-evaluability rate of 10%). Mean actual durations of pharmacological prophylaxis from surgery were: 28.4 ± 13.7 (THA), 29.3 ± 13.9 (HFS), and 28.7 ± 14.1 days (KA). ACCP-adequate VTE prophylaxis was received by 66.5% of patients (60.9% THA, 55.4% HFS, and 88.7% KA). Prophylaxis inadequacies were mainly due to inadequate prescription, non-recommended prophylaxis prescription at discharge, or too short prophylaxis prescribed. In high-risk orthopaedic surgery patients with hospital-initiated prophylaxis, there is a gap between ACCP recommendations, prescribed and actual prophylaxis received, mainly due to inadequate prescription at discharge.

Post-discharge compliance to venous thromboembolism prophylaxis in high-risk orthopaedic surgery: results from the ETHOS registry.

Venous thromboembolism (VTE) risk persists for several weeks following high-risk orthopaedic surgery (HROS). The ETHOS registry evaluated post-operative VTE prophylaxis prescribed, and actual VTE prophylaxis received, compared with the 2004 American College of Chest Physicians (ACCP) guidelines in HROS patients. We performed a subanalysis of ETHOS to assess patient compliance with ACCP-adherent prophylaxis after discharge and the factors predicting poor compliance. Consecutive patients undergoing hip fracture surgery, total hip arthroplasty, or knee arthroplasty were enrolled at discharge from 161 centres in 17 European countries if they had received adequate in-hospital VTE prophylaxis. Data on prescribed and actual prophylaxis received were obtained from hospital charts and patient post-discharge diaries. Good compliance was defined as percentage treatment intake ≥80% with no more than two consecutive days without treatment. A total of 3,484 patients (79.4%) received ACCP-adherent anticoagulant prescription at discharge and 2,999 (86.0%) had an evaluable patient diary. In total, 87.7% of evaluable patients were compliant with prescribed treatment after discharge. The most common reason for non-compliance (33.4%) was "drug was not bought". Injection of treatment was not a barrier to good compliance. Main factors affecting compliance related to purchase of and access to treatment, patient education, the person responsible for administering injections, country, and type of hospital ward at discharge. Within our study population, patient compliance with ACCP-adherent thromboprophylaxis prescribed at discharge was good. Improvements in patient education and prescribing practices at discharge may be important in further raising compliance levels in high-risk orthopaedic surgery patients.