Improving shared decision-making in vascular surgery by implementing decision support tools: study protocol for the stepped-wedge cluster-randomised OVIDIUS trial.

BACKGROUND: Shared decision-making improves the quality of patient care. Unfortunately, shared decision-making is not yet common practice among vascular surgeons. Thus, decision support tools were developed to assist vascular surgeons and their patients in using shared decision-making. This trial aims to evaluate the effectiveness and implementation of decision support tools to improve shared decision-making during vascular surgical consultations in which a treatment decision is to be made. METHODS: The study design is a multicentre stepped-wedge cluster-randomised trial. Eligible patients are adult patients, visiting the outpatient clinic of a participating medical centre for whom several treatment options are feasible and who face a primary treatment decision for their abdominal aortic aneurysm, carotid artery disease, intermittent claudication, or varicose veins. Patients and vascular surgeons in the intervention group receive decision support tools that may help them adopt shared decision-making when making the final treatment decision. These decision support tools are decision aids, consultation cards, decision cards, and a practical training. Decision aids are informative websites that help patients become more aware of the pros and cons of the treatment options and their preferences regarding the treatment choice. Consultation cards with text or decision cards with images are used by vascular surgeons during consultation to determine which aspect of a treatment is most important to their patient. In the training vascular surgeons can practice shared decision-making with a patient actor, guided by a medical psychologist. This trial aims to include 502 vascular surgical patients to achieve a clinically relevant improvement in shared decision-making of 10 out of 100 points, using the 5-item OPTION instrument to score the audio-recordings of consultations. DISCUSSION: In the OVIDIUS trial the available decision support tools for vascular surgical patients are implemented in clinical practice. We will evaluate whether these tools actually improve shared decision-making in the consultation room. The stepped-wedge cluster-randomised study design will ensure that at the end of the study all participating centres have implemented at least some of the decision support tools and thereby a certain level of shared decision-making. TRIAL REGISTRATION: Netherlands Trial Registry, NTR6487 . Registered 7 June 2017. URL: http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=6487.

Delphi Study to Reach International Consensus Among Vascular Surgeons on Major Arterial Vascular Surgical Complications.

BACKGROUND: The complications discussed with patients by surgeons prior to surgery vary, because no consensus on major complications exists. Such consensus may improve informed consent and shared decision-making. This study aimed to achieve consensus among vascular surgeons on which complications are considered 'major' and which 'minor,' following surgery for abdominal aortic aneurysm (AAA), carotid artery disease (CAD) and peripheral artery disease (PAD). METHODS: Complications following vascular surgery were extracted from Cochrane reviews, national guidelines, and reporting standards. Vascular surgeons from Europe and North America rated complications as major or minor on five-point Likert scales via an electronic Delphi method. Consensus was reached if ≥ 80% of participants scored 1 or 2 (minor) or 4 or 5 (major). RESULTS: Participants reached consensus on 9-12 major and 6-10 minor complications per disease. Myocardial infarction, stroke, renal failure and allergic reactions were considered to be major complications of all three diseases. All other major complications were treatment specific or dependent on disease severity, e.g., spinal cord ischemia, rupture following AAA repair, stroke for CAD or deep wound infection for PAD. CONCLUSION: Vascular surgeons reached international consensus on major and minor complications following AAA, CAD and PAD treatment. This consensus may be helpful in harmonizing the information patients receive and improving standardization of the informed consent procedure. Since major complications differed between diseases, consensus on disease-specific complications to be discussed with patients is necessary.

Legal perspectives on black box recording devices in the operating environment.

BACKGROUND: A video and medical data recorder in the operating theatre is possible, but concerns over privacy, data use and litigation have limited widespread implementation. The literature on legal considerations and challenges to overcome, and guidelines related to use of data recording in the surgical environment, are presented in this narrative review. METHODS: A review of PubMed and Embase databases and Cochrane Library was undertaken. International jurisprudence on the topic was searched. Practice recommendations and legal perspectives were acquired based on experience with implementation and use of a video and medical data recorder in the operating theatre. RESULTS: After removing duplicates, 116 citations were retrieved and abstracts screened; 31 articles were assessed for eligibility and 20 papers were finally included. According to the European General Data Protection Regulation and US Health Insurance Portability and Accountability Act, researchers are required to make sure that personal data collected from patients and healthcare professionals are used fairly and lawfully, for limited and specifically stated purposes, in an adequate and relevant manner, kept safe and secure, and stored for no longer than is absolutely necessary. Data collected for the sole purpose of healthcare quality improvement are not required to be added to the patient's medical record. CONCLUSION: Transparency on the use and purpose of recorded data should be ensured to both staff and patients. The recorded video data do not need to be used as evidence in court if patient medical records are well maintained. Clear legislation on data responsibility is needed to use the medical recorder optimally for quality improvement initiatives.

ANTECEDENTES: Es posible instalar un sistema de video y grabación de datos médicos en el quirófano, pero su implementación se ha visto limitada por las dudas relativas a la privacidad, uso de datos y aspectos de litigio. Estas dudas deberían superarse, motivo por el que en este trabajo se proponen unas guías sobre el uso de sistemas de registro en el ambiente quirúrgico. MÉTODOS: Se realizó una revisión en las bases de datos Pubmed y Embase y de la Biblioteca Cochrane. Se buscó la jurisprudencia internacional sobre el tema. Se establecieron unas recomendaciones prácticas y de las perspectivas legales adquiridas a través de la experiencia de la implementación y el uso de sistemas de video y registro de datos médicos en el quirófano. RESULTADOS: Se obtuvieron 116 referencias, de las que una vez eliminadas las duplicadas (n = 5) y revisados los resumenes, 31 artículos cumplían los criterios de eligibilidad. En el estudio final se incluyeron 20 artículos. De acuerdo con la Ley Orgánica de Protección de Datos (General Data Protection Regulation, GDRP) y la Ley de Transferencia y Responsabilidad de Seguro Médico (Health Insurance Portability and Accountability Act, HIPAA), los investigadores deben asegurar que los datos personales recopilados pertenecientes a los pacientes y profesionales de la salud se utilicen de manera justa y legal, con fines definidos y bien establecidos, de manera adecuada y relevante, y mantenidos a resguardo y almacenados no más tiempo del estrictamente necesario. No es necesario que los datos recopilados con el único propósito de mejorar la calidad de la atención médica se agreguen a la historia clínica del paciente. CONCLUSIÓN: Se debe asegurar por parte del personal sanitario como del paciente, la transparencia tanto en la utilización como en el objetivo de los datos almacenados. Los datos registrados en video no es necesario que sean usados como evidencia en procesos judiciales si la historia clínica de los pacientes cumple los estandares establecidos. Se precisa una legislación clara sobre la responsabilidad de los datos para la utilización óptima de los registros médicos en las iniciativas de mejora de la calidad.

[Video recording and data collection in the operating room: the way to a 'just culture' in the OR]. / Video- en dataregistratie op de operatiekamer.

The Academic Medical Center, Amsterdam, has started a trial to evaluate the usefulness to team debriefings of performance reports generated by a medical data recorder (MDR) in the operating room (OR). Outcome performance reports in structured debriefings in a secure, non-punitive environment are likely to heighten the level of situational awareness of OR teams. This may prevent future error. In addition, the use of video and - even more likely - use of an MDR may contribute to establishing a 'just culture' in the OR. MDRs offer a wealth of data, but only if these data are processed well do the resulting outcome reports reveal insights useful for structured debriefings. The implementation of video recordings or MDRs must be preceded by carefully addressing privacy and litigation issues relating to both OR staff and patients. In this article, we address viewpoints and discuss implementation strategy and the legal considerations involved in enabling the use of video and data registration in the OR.

Biomechanical Imaging Markers as Predictors of Abdominal Aortic Aneurysm Growth or Rupture: A Systematic Review.

OBJECTIVES: Biomechanical characteristics, such as wall stress, are important in the pathogenesis of abdominal aortic aneurysms (AAA) and can be visualised and quantified using imaging techniques. This systematic review aims to present an overview of all biomechanical imaging markers that have been studied in relation to AAA growth and rupture. METHODS: This systematic review followed the PRISMA guidelines. A search in Medline, Embase, and the Cochrane Library identified 1503 potentially relevant articles. Studies were included if they assessed biomechanical imaging markers and their potential association with growth or rupture. RESULTS: Twenty-seven articles comprising 1730 patients met the inclusion criteria. Eighteen studies performed wall stress analysis using finite element analysis (FEA), 13 of which used peak wall stress (PWS) to quantify wall stress. Ten of 13 case control FEA studies reported a significantly higher PWS for symptomatic or ruptured AAAs than for intact AAAs. However, in some studies there was confounding bias because of baseline differences in aneurysm diameter between groups. Clinical heterogeneity in methodology obstructed a meaningful meta-analysis of PWS. Three of five FEA studies reported a significant positive association between several wall stress markers, such as PWS and 99th percentile stress, and growth. One study reported a significant negative association and one other study reported no significant association. Studies assessing wall compliance, the augmentation index and wall stress analysis using Laplace's law, computational fluid dynamics and fluid structure interaction were also included in this systematic review. CONCLUSIONS: Although PWS is significantly higher in symptomatic or ruptured AAAs in most FEA studies, confounding bias, clinical heterogeneity, and lack of standardisation limit the interpretation and generalisability of the results. Also, there is conflicting evidence on whether increased wall stress is associated with growth.

Inflammation as a Predictor of Abdominal Aortic Aneurysm Growth and Rupture: A Systematic Review of Imaging Biomarkers.

BACKGROUND: Methods are required to identify abdominal aortic aneurysms (AAAs) at increased risk of rupture. Inflammatory characteristics of AAA can be visualised using advanced imaging techniques and have been proposed as potential predictors of aneurysm progression. The objective of this review was to determine which inflammatory imaging biomarkers are associated with AAA growth and rupture. METHODS: A systematic review was carried out in accordance with the PRISMA guidelines. The electronic databases of Medline (PubMed), Embase, and the Cochrane Library were searched up to January 1, 2016 for studies to determine the potential association between inflammatory imaging biomarkers and AAA growth or rupture. RESULTS: Seven studies were included, comprising 202 AAA patients. (18)F-fluoro-deoxy-glucose positron emission tomography ((18)F-FDG PET-CT) was evaluated in six studies. Magnetic resonance imaging with ultrasmall superparamagnetic particles of iron oxide (USPIO-MRI) was evaluated in one study. Two of six (18)F-FDG PET-CT studies reported a significant negative correlation (r=.383, p = .015) or a significant negative association (p = .04). Four of six (18)F-FDG PET-CT studies reported no significant association between (18)F-FDG uptake and AAA growth. The single study investigating USPIO-MRI demonstrated that AAA growth was three times higher in patients with focal USPIO uptake in the AAA wall compared to patients with diffuse or no USPIO uptake in the wall (0.66 vs. 0.24 vs. 0.22 cm/y, p = .020). In the single study relating (18)F-FDG uptake results to AAA rupture, the association was not significant. CONCLUSIONS: Current evidence shows contradictory associations between (18)F-FDG uptake and AAA growth. Data on the association with rupture are insufficient. Based on the currently available evidence, neither (18)F-FDG PET-CT nor USPIO-MRI can be implemented as growth or rupture prediction tools in daily practice. The heterogeneous results reflect the complex and partially unclear relationship between inflammatory processes and AAA progression.

[Number unnecessarily treated in relation to harm: a concept physicians and patients need to understand]. / 'Number unnecessarily treated' in relatie tot complicaties.

Physicians are legally and ethically compelled to present their patients with available evidence on the potentially beneficial and harmful effects of a proposed medical or surgical treatment.

Midterm Re-interventions and Survival After Endovascular Versus Open Repair for Ruptured Abdominal Aortic Aneurysm.

OBJECTIVE: To compare the midterm re-intervention and survival rates after EVAR and OR for ruptured abdominal aortic aneurysms (RAAA). METHODS: Observational cohort study including all consecutive RAAA patients between 2004 and 2011 in 10 hospitals in the Amsterdam ambulance region. The primary end point was re-interventions within 5 years of the primary intervention. The secondary end point was death. The outcomes were estimated by survival analyses, compared using the logrank test, and subsequently adjusted for possible confounders using Cox proportional hazard models. Re-interventions were estimated in all patients and in patients who survived their hospital stay. RESULTS: Of 467 patients with a RAAA, 73 were treated by EVAR and 394 by OR. Five years after the primary intervention, the rates of freedom from re-intervention were 55% for EVAR (26/73, 95% CI: 41-69%) and 60% for OR (130/394, 95% CI: 55-66%) (p = .96). After adjustment for age, sex, comorbidity, and pre-operative hemodynamic stability, the risk of re-intervention was similar (HR 1.01, 95% CI: 0.65-1.55). The survival rates were 36% for EVAR (45/73, 95% CI: 24-47%) and 38% for OR (235/394, 95% CI: 33-43%) (p = .83). In 297 patients who survived their hospital stay, the rates of freedom from re-intervention were 66% for EVAR (15/54, 95% CI: 52-81%) and 90% for OR (20/243, 95% CI: 86-95%) (p < .01). After adjustment for age and sex, the risk of re-intervention was higher after EVAR (HR 0.27, 95% CI: 0.14-0.52). CONCLUSIONS: Five years after the primary intervention, endovascular and open repair for ruptured abdominal aortic aneurysm resulted in similar re-intervention and survival rates. However, in patients who survived their hospital stay the re-intervention rate was higher for EVAR than for OR.

Editor's Choice--External Validation of Models Predicting Survival After Ruptured Abdominal Aortic Aneurysm Repair.

OBJECTIVE: Prediction of survival after intervention for ruptured abdominal aortic aneurysms (RAAA) may support case mix comparison and tailor the prognosis for patients and relatives. The objective of this study was to assess the performance of four prediction models: the updated Glasgow Aneurysm Score (GAS), the Vancouver scoring system, the Edinburgh Ruptured Aneurysm Score (ERAS), and the Hardman index. DESIGN, MATERIALS, AND METHODS: This was a retrospective cohort study in 449 patients in ten hospitals with a RAAA (intervention between 2004 and 2011). The primary endpoint was combined 30 day or in hospital death.The accuracy of the prediction models was assessed for discrimination (area under the curve [AUC]). An AUC>0.70 was considered sufficiently accurate. In studies with sufficiently accurate discrimination, correspondence between the predicted and observed outcomes (i.e. calibration) was recalculated. RESULTS: The AUC of the updated GAS was 0.71 (95% confidence interval [CI] 0.66-0.76), of the Vancouver score was 0.72 (95% CI 0.67-0.77), and of the ERAS was 0.58 (95% CI 0.52-0.65). After recalibration, predictions by the updated GAS slightly overestimated the death rate, with a predicted death rate 60% versus observed death rate 54% (95% CI 44-64%). After recalibration, predictions by the Vancouver score considerably overestimated the death rate, with a predicted death rate 82% versus observed death rate 62% (95% CI 52-71%). Performance of the Hardman index could not be assessed on discrimination and calibration, because in 57% of patients electrocardiograms were missing. CONCLUSIONS: Concerning discrimination and calibration, the updated GAS most accurately predicted death after intervention for a RAAA. However, the updated GAS did not identify patients with a ≥95% predicted death rate, and therefore cannot reliably support the decision to withhold intervention.

A decision aid regarding treatment options for patients with an asymptomatic abdominal aortic aneurysm: a randomised clinical trial.

OBJECTIVE: Abdominal aortic aneurysm patients tend to be informed inconsistently and incompletely about their disorder and the treatment options open to them. The objective of this trial was to evaluate whether these patients are better informed and experience less decisional conflict regarding their treatment options after viewing a decision aid. DESIGN: A six-centre, randomised clinical trial comparing a decision aid plus regular information versus regular information from the surgeon. METHODS: Included patients had recently been diagnosed with an asymptomatic abdominal aortic aneurysm at least 4 cm in diameter. The decision aid consisted of a one-time viewing of an interactive CD-ROM elaborating on elective surgery versus watchful waiting. Generally, the decision aid advised patients with aneurysms less than 5.5 cm to agree to watchful waiting, for larger aneurysms the decision aid provided insight into the balance of benefit and harm of surgical and conservative approaches, taking into account age, co-morbidity and size of the aneurysm. The primary outcome was patient decisional conflict measured at 1 month follow-up (Decisional Conflict Scale). Secondary outcomes were patient knowledge, anxiety and satisfaction. RESULTS: In 178 aneurysm patients, decisional conflict scores did not differ significantly between the decision aid and the regular information groups (22 vs. 24 on the 0-100 Decisional Conflict Scale; p = .33). Patients in the decision aid group had significantly better knowledge (10.0 vs. 9.4 out of 13 points; p = .04), whereas anxiety levels (4.4 and 5.0 on a 0-21 scale; p = .73) and satisfaction scores (74 and 73 on a 0-100 scale; p = .81) were similar in both groups. CONCLUSION: In addition to regular patient-surgeon communication, a decision aid helps to share treatment decisions with abdominal aortic aneurysm patients by increasing their knowledge about the disorder and available treatment options without raising anxiety levels; however, it does not reduce decisional conflict, nor does it improve satisfaction.

Hyperbaric oxygen for the treatment of diabetic foot ulcers: a systematic review.

OBJECTIVE: A systematic review of randomized clinical trials (RCTs) to assess the additional value of hyperbaric oxygen therapy (HBOT) in promoting the healing of diabetic foot ulcers and preventing amputations was performed. METHODS: MEDLINE, Embase, and the Cochrane Library were searched to identify RCTs in patients with diabetic foot ulcers published up to August 2013. Eligible studies reported the effectiveness of adjunctive HBOT with regard to wound healing, amputations, and additional interventions. RESULTS: Seven of the 669 identified articles met the inclusion criteria, comprising 376 patients. Three trials included 182 patients with ischaemic ulcers, two trials studied 64 patients with non-ischaemic ulcers, and two trials comprising 130 patients did not specify ulcer type. Two trials were of good methodological quality. Pooling of data was deemed inappropriate because of heterogeneity. Two RCTs in patients with ischaemic ulcers found increased rates of complete healing at 1-year follow-up (number needed to treat (NNT) 1.8 (95% CI: 1.1 to 4.6) and 4.1 (95% CI: 2.3 to 19)), but found no difference in amputation rates. A third trial in ischaemic ulcers found significantly lower major amputation rates in patients with HBOT (NNT 4.2, 95% CI: 2.4 to 17), but did not report on wound healing. None of the RCTs in non-ischaemic ulcers reported differences in wound healing or amputation rates. Two trials with unknown ulcer types reported beneficial effects on amputation rates, although the largest trial used a different definition for both outcomes. HBOT did not influence the need for additional interventions. CONCLUSION: Current evidence shows some evidence of the effectiveness of HBOT in improving the healing of diabetic leg ulcers in patients with concomitant ischaemia. Larger trials of higher quality are needed before implementation of HBOT in routine clinical practice in patients with diabetic foot ulcers can be justified.

Effect of regional cooperation on outcomes from ruptured abdominal aortic aneurysm.

BACKGROUND: Care for patients with a ruptured abdominal aortic aneurysm (rAAA) in the Amsterdam ambulance region (The Netherlands) was concentrated into vascular centres with a 24-h full emergency vascular service in cooperation with seven referring regional hospitals. Previous population-based survival after rAAA in the Netherlands was 46 (95 per cent confidence interval (c.i.) 43 to 49) per cent. It was hypothesized that regional cooperation would improve survival. METHODS: This was a prospective observational cohort study carried out simultaneously with the Amsterdam Acute Aneurysm Trial. Consecutive patients with an rAAA between 2004 and 2011 in all ten hospitals in the Amsterdam region were included. The primary outcome was 30-day survival after admission. Multivariable logistic regression, including age, sex, co-morbidity, intervention (endovascular or open repair), preoperative systolic blood pressure, cardiopulmonary resuscitation and year of intervention, was used to assess the influence of hospital setting on survival. RESULTS: Of 453 patients with rAAA from the Amsterdam ambulance region, 61 did not undergo intervention; 352 patients were treated surgically at a vascular centre and 40 at a referring hospital. The regional survival rate was 58.5 (95 per cent c.i. 53.9 to 62.9) per cent (265 of 453). After multivariable adjustment, patients treated at a vascular centre had a higher survival rate than patients treated surgically at a referring hospital (adjusted odds ratio 3.18, 95 per cent c.i. 1.43 to 7.04). CONCLUSION: After regional cooperation, overall survival of patients with an rAAA improved. Most patients were treated in a vascular centre and in these patients survival rates were optimal.

Outcomes after open repair for ruptured abdominal aortic aneurysms in patients with friendly versus hostile aortoiliac anatomy.

OBJECTIVES: In patients with a ruptured abdominal aortic aneurysm (RAAA), anatomic suitability for endovascular aneurysm repair (EVAR) depends on aortic neck and iliac artery characteristics. If the aortoiliac anatomy is unsuitable for EVAR ("hostile anatomy"), open repair (OR) is the next option. We hypothesized that the death rate for OR is higher in patients with hostile anatomy than in patients with friendly anatomy. METHODS: We conducted an observational cohort study in 279 consecutive patients with an RAAA treated with OR between 2004 and 2011. The primary endpoint was 30-day or in-hospital death. Aortoiliac anatomy (friendly vs. hostile) was determined prospectively by the vascular surgeon and the interventional radiologist treating the patient. A multivariable logistic regression analysis was done to assess the risk of dying in patients with hostile anatomy after adjustment for age, sex, comorbidity, and hemodynamic stability. RESULTS: Aortoiliac anatomy was friendly in 71 patients and hostile in 208 patients. Death rate was 38% (95% confidence interval (CI): 28 to 50%) in patients with friendly anatomy and 30% (95% CI: 24 to 37%) in patients with hostile anatomy (p = .23). After multivariable adjustment, the risk of dying was not higher in patients with hostile anatomy (adjusted odds ratio 0.744, 95% CI 0.394 to 1.404). CONCLUSION: The death rate after open repair for an RAAA is comparable in patients with friendly and hostile aortoiliac anatomy.

Medical liability insurance claims after treatment of varicose veins.

OBJECTIVE: Since insight into the reason for filing claims after treatment of varicose veins of the lower extremity might help prevent future claims, we determined the incidence of and reasons for medical liability insurance claims after such treatments in the Netherlands. METHOD: We performed a retrospective review of all medical liability insurance claims after varicose vein treatment handled by MediRisk between January 1993 and December 2007. RESULTS: A total of 144 claims were filed of which 104 were closed by the end of the study period. Nerve injury (n = 28), skin necrosis following sclerotherapy (n = 17), deep vein injury (n = 11) and insufficient communication (n = 9) accounted for more than 60% of all claims. Claims were equally distributed among registrars and consultants. Some 41 of the 104 closed claims were accepted. In 27 of the accepted cases, the physician had obviously failed in providing the care as expected from a medical practitioner allowed to perform these treatments. The majority of these 27 claims were due to injury of nerves (n = 11) or deep veins (n = 9). CONCLUSION: The incidence of claims after treatment of varicose veins in the Netherlands is low. Proper knowledge of anatomy and adequate communication, along with the introduction of less invasive treatments might prevent future claims.

Statistical or clinical improvement? Determining the minimally important difference for the vascular quality of life questionnaire in patients with critical limb ischemia.

OBJECTIVE: Interpreting whether changes in quality of life (Qol) in patients with peripheral arterial disease (PAD) are not only statistically significant but also clinically relevant, may be difficult. This study introduces the concept of the minimally important difference (MID) to vascular surgeons using Qol outcomes of patients treated for chronic critical limb ischemia (CLI). METHODS: The Vascular Quality of Life (VascuQol) questionnaire was recorded at baseline before treatment and after 6 months follow-up in consecutive patients with CLI treated between May 2007 and May 2010. Statistical significance of change in VascuQol score was tested with the Wilcoxon Signed Rank test. The MID for the VascuQol score was determined using a clinical anchor-based method and a distribution-based method. RESULTS: A total of 127 patients with CLI completed the VascuQol after 6 months. The VascuQol sum scores improved from 3.0 (range 1.1-5.9) at baseline to 4.0 (range 1.2-6.7) at 6 months (p < .001). The MID on the VascuQol sumscore indicating a clinically important change determined with the anchor-based method was 0.36, and with the distribution-based method was 0.48. On an individual level, depending on the method of determining the MID, this resulted in 60% to 68% of the patients with an important benefit. CONCLUSIONS: Expression of changes in Qol by means of the MID provides better insight into clinically important changes than statistical significance.

Systematic review and meta-analysis of population-based mortality from ruptured abdominal aortic aneurysm.

BACKGROUND: A substantial proportion of patients with a ruptured abdominal aortic aneurysm (rAAA) die outside hospital. The objective of this study was to estimate the total mortality, including prehospital deaths, of patients with rAAA. METHODS: This was a systematic review and meta-analysis following the MOOSE guidelines. The Embase, MEDLINE and Cochrane Library databases were searched. All population-based studies reporting both prehospital and in-hospital mortality in patients with rAAA were included. Studies were assessed for methodological quality and heterogeneity, and pooled estimates of mortality from rAAA were calculated using a random-effects model. RESULTS: From a total of 3667 studies, 24 retrospective cohort studies, published between 1977 and 2012, met the inclusion criteria. The quality of included studies varied, in particular the method of determining prehospital deaths from rAAA. The estimated pooled total mortality rate was 81 (95 per cent confidence interval 78 to 83) per cent. A decline in mortality was observed over time (P = 0·002); the pooled estimate of total mortality in high-quality studies before 1990 was 86 (83 to 89) per cent, compared with 74 (72 to 77) per cent since 1990. Some 32 (27 to 37) per cent of patients with rAAA died before reaching hospital. The in-hospital non-intervention rate was 40 (33 to 47) per cent, which also declined over the years. CONCLUSION: The pooled estimate of total mortality from rAAA is very high, although it has declined over the years. Most patients die outside hospital, and there is no surgical intervention in a considerable number of those who survive to reach hospital.

Diagnostic performance of computed tomography angiography in peripheral arterial injury due to trauma: a systematic review and meta-analysis.

OBJECTIVES: To evaluate the diagnostic accuracy of computed tomography angiography (CTA) in detecting arterial lesions in patients with suspected arterial injury of the upper or lower extremity due to trauma. METHODS: A systematic review and meta-analysis was carried out. Medline and Embase were searched on August 13, 2012, for studies comparing CTA with surgery, digital subtraction angiography (DSA), or follow-up, which allowed extraction of data into two-by-two tables. The methodological quality of included studies was assessed using the QUADAS tool. Summary estimates of sensitivity and specificity of CTA in identifying or excluding arterial lesions were obtained using a bivariate model. RESULTS: This review included 11 studies making up a total of 891 trauma patients. The included studies were of moderate methodological quality and at risk of misclassification and verification bias. Some 4.2% of all CTA studies were non-diagnostic. The summary estimates of sensitivity and specificity of CTA were 96.2% (95% CI 93.5-97.8%) and 99.2% (95% CI 96.8-99.8%), respectively. CONCLUSION: Despite methodological flaws, the excellent estimates of sensitivity and specificity indicate that CTA is an accurate modality for evaluating arterial lesions in patients with extremity trauma and can replace DSA.

First clinical experience with polysol solution: pilot study in living kidney transplantation.

In this study, we assessed the safety of the new organ preservation solution polysol solution in the clinical setting of living kidney transplantation. We conducted a prospective pilot study in nine adult donor-recipient couples using polysol solution for washout and cold storage of kidney grafts. Adverse reactions possibly related to the use of polysol solution as well as renal function at 1, 6, and 12 months after transplantation were monitored. All living kidney transplantation performed in adults in our center within 2002 to 2008 using the University of Winconsin solution served as controls (n = 190). The use of polysol solution was associated with a higher acute rejection rate compared to University of Wisconsin solution at all time points. Also, antibody-mediated rejection occurred more frequently in the polysol group. Renal function at all time points was also comparable between the groups. This pilot study in living kidney transplantation is the first clinical study on the use of polysol solution. Although the study was not powered on the endpoint rejection, we observed a high number of acute rejection and antibody-mediated rejection episodes in recipients of polysol solution preserved grafts as compared to University of Wisconsin solution controls. As a consequence the study was terminated prematurely.

SUPERvised exercise therapy or immediate PTA for intermittent claudication in patients with an iliac artery obstruction--a multicentre randomised controlled trial; SUPER study design and rationale.

INTRODUCTION: Treatment of intermittent claudication (IC) due to peripheral arterial disease (PAD) is aimed at improving walking distance and includes secondary prevention of cardiovascular disease. Both supervised exercise therapy (SET) and percutaneous transluminal angioplasty (PTA) have proven to be effective in increasing maximum and pain-free walking distance in IC. However, the optimal treatment strategy in patients with IC due to iliac artery stenosis or occlusion remains unclear. OBJECTIVE: To compare the (cost-) effectiveness of initial PTA versus initial SET in patients with disabling IC due to an iliac artery obstruction. DESIGN: In a multicentre randomised controlled trial 400 consecutive patients with IC will be randomly assigned to PTA (with additional stent placement on indication) or SET. Primary outcomes are maximum walking distance and health-related quality of life measured using the disease-specific VascuQol instrument after 1 year. Secondary outcomes are pain-free walking distance, functional status, generic quality of life, complications related to each of the interventions, additional interventions, treatment failures and costs (cost-effectiveness and cost-utility) after 1 year. CONCLUSION AND IMPLICATIONS: Based on the results of this proposed large study well-founded adjustments of existing guidelines on the treatment of iliac artery occlusive disease can be implemented (Clinical Trials.gov NCT01385774; Nederlands Trial Register NTR2776).

Comparison of preserved vascular allografts using glycerol and University of Wisconsin solution in a goat carotid artery transplantation model.

BACKGROUND: Prosthetic grafts have poor patency rates in peripheral arterial reconstructions. Glycerol (GL)-preserved grafts are an alternative. The aim of this study was to examine patency, graft morphology and function of GL-preserved allografts in a goat carotid artery animal model. METHODS: The first group (n = 7) underwent bilateral replacement of the carotid artery by a carotid allograft that was preserved in GL for 1 week. In the second group (n = 5), a carotid artery allograft that was preserved in University of Wisconsin solution (UW) for 48 h was used. In the third group (n = 5), the jugular vein (autologous vein, AU) was used. The follow-up was 3 months. RESULTS: One UW graft and 1 GL graft occluded in the first 24 h postoperatively. Three-month primary patency rates for GL, UW and AU grafts were 93, 100 and 80%, respectively (p = 0.39). Graft diameter was increased in UW allografts (p < 0.005), whereas GL allografts remained unchanged. After explantation, GL allografts demonstrated contraction and relaxation capacity and lower intimal thickness (p < 0.001). CONCLUSION: GL preservation has proven to be a feasible method for arterial allograft transplantation in a large animal model with decreased intimal hyperplasia and renewed functional capability.