Learning insertion of a Resuscitative Endovascular Balloon Occlusion of the Aorta (REBOA) catheter: Is clinical experience necessary? A prospective trial.

BACKGROUND: Resuscitative endovascular balloon occlusion of the aorta (REBOA) is an emerging and potentially life-saving procedure, necessitating qualified operators in an increasing number of centres. The procedure shares technical elements with other vascular access procedures using the Seldinger technique, which is mastered by doctors not only in endovascular specialties but also in trauma surgery, emergency medicine, and anaesthesiology. We hypothesised that doctors mastering the Seldinger technique (experienced anaesthesiologist) would learn the technical aspects of REBOA with limited training and remain technically superior to doctors unfamiliar with the Seldinger technique (novice residents) given similar training. METHODS: This was a prospective trial of an educational intervention. Three groups of doctors were enroled: novice residents, experienced anaesthesiologists, and endovascular experts. The novices and the anaesthesiologists completed 2.5 h of simulation-based REBOA training. Their skills were tested before and 8-12 weeks after training using a standardised simulated scenario. The endovascular experts, constituting a reference group, were equivalently tested. All performances were video recorded and rated by three blinded experts using a validated assessment tool for REBOA (REBOA-RATE). Performances were compared between groups and with a previously published pass/fail cutoff. RESULTS: Sixteen novices, 13 board-certified specialists in anaesthesiology, and 13 endovascular experts participated. Before training, the anaesthesiologists outperformed the novices by 30 percentage points of the maximum REBOA-RATE score (56% (SD 14.0) vs 26% (SD 17%), p<0.01). After training, there was no difference in skills between the two groups (78% (SD 11%) vs 78 (SD 14%), p = 0.93). Neither group reached the endovascular experts' skill level (89% (SD 7%), p<0.05). CONCLUSION: For doctors mastering the Seldinger technique, there was an initial inter-procedural transfer of skills advantage when performing REBOA. However, after identical simulation-based training, novices performed equally well to anaesthesiologists, indicating that vascular access experience is not a prerequisite to learning the technical aspects of REBOA. Both groups would need more training to reach technical proficiency.

Long Term Results of a Randomised Trial of Stenting of the Superficial Femoral Artery for Intermittent Claudication.

OBJECTIVE: Primary stenting of the superficial femoral artery (SFA) in intermittent claudication (IC) has been shown to increase health related quality of life (HRQoL) after 12 and 24 months. An extended follow up of HRQoL 36 and 60 months after randomisation is presented. METHODS: A multicentre randomised controlled trial was conducted at seven vascular clinics in Sweden between 2010 and 2020. One hundred patients randomised to either primary stenting and best medical treatment (BMT; n = 48) or BMT alone (n = 52) were followed for 60 months. HRQoL, assessed by the Short Form 36 Health Survey (SF-36) and EuroQoL 5 dimensions (EQ5D) 36 and 60 months after randomisation, was the primary outcome. Walking Impairment Questionnaire (WIQ) score, re-interventions, progression to chronic limb threatening ischaemia (CLTI), amputation, and death were secondary outcomes. RESULTS: At the 36 month follow up, the stent group (n = 32) had statistically significantly better scores in the SF-36 domain "Role Physical" (p = .023) and the Physical Component Summary (p = .032) compared with the control group (n = 30); however, there was no statistically significant difference in EQ5D scores (p = .52). WIQ was statistically significantly better in the stent group compared with the control group (p = .029) at 36 months. At the 60 month follow up, no statistically significant difference in HRQoL was seen between patients in the stent (n = 31) and control groups (n = 32). Crossover from the control group to the stent group was 25% at 60 months. There were no differences in progression to CLTI, amputation (2.1% vs. 1.9%), or mortality (14.6% vs. 15.4%) between groups. CONCLUSION: In patients with IC caused by isolated SFA lesions, primary stenting conferred benefits to HRQoL until 36 months from treatment vs. BMT alone, but these benefits were no longer detectable at 60 months, where a high crossover rate affected the power of the final analysis.

Center experience and other determinants of patient radiation exposure during prostatic artery embolization: a retrospective study in three Scandinavian centers.

OBJECTIVES: To evaluate the effects of center experience and a variety of patient- and procedure-related factors on patient radiation exposure during prostatic artery embolization (PAE) in three Scandinavian centers with different PAE protocols and levels of experience. Understanding factors that influence radiation exposure is crucial in effective patient selection and procedural planning. METHODS: Data were collected retrospectively for 352 consecutive PAE procedures from January 2015 to June 2020 at the three centers. Dose area product (DAP (Gy·cm2)) was selected as the primary outcome measure of radiation exposure. Multiple patient- and procedure-related explanatory variables were collected and correlated with the outcome variable. A multiple linear regression model was built to determine significant predictors of increased or decreased radiation exposure as reflected by DAP. RESULTS: There was considerable variation in DAP between the centers. Intended unilateral PAE (p = 0.03) and each 10 additional patients treated (p = 0.02) were significant predictors of decreased DAP. Conversely, increased patient body mass index (BMI, p < 0.001), fluoroscopy time (p < 0.001), and number of digital subtraction angiography (DSA) acquisitions (p < 0.001) were significant predictors of increased DAP. CONCLUSIONS: To minimize patient radiation exposure during PAE radiologists may, in collaboration with clinicians, consider unilateral embolization, pre-interventional CTA for procedure planning, using predominantly anteroposterior (AP) projections, and limiting the use of cone-beam CT (CBCT) and fluoroscopy. KEY POINTS: • Growing center experience and intended unilateral embolization decrease patient radiation exposure during prostatic artery embolization. • Patient BMI, fluoroscopy time, and number of DSA acquisitions are associated with increased DAP during procedures. • Large variation in radiation exposure between the centers may reflect the use of CTA before and CBCT during the procedure.

Editor's Choice - Cost Effectiveness of Primary Stenting in the Superficial Femoral Artery for Intermittent Claudication: Two Year Results of a Randomised Multicentre Trial.

OBJECTIVE: Invasive treatment of intermittent claudication (IC) is commonly performed, despite limited evidence of its cost effectiveness. IC symptoms are mainly caused by atherosclerotic lesions in the superficial femoral artery (SFA), and endovascular treatment is performed frequently. The aim of this study was to investigate its cost effectiveness vs. non-invasive treatment. METHODS: One hundred patients with IC due to lesions in the SFA were randomised to treatment with primary stenting, best medical treatment (BMT) and exercise advice (stent group), or to BMT and exercise advice alone (control group). Patients were recruited at seven hospitals in Sweden. For this analysis of cost effectiveness after 24 months, 84 patients with data on quality adjusted life years (QALY; based on the EuroQol Five Dimensions EQ-5D 3L™ questionnaire) were analysed. Patient registry and imputed cost data were used for accumulated costs regarding hospitalisation and outpatient visits. RESULTS: The mean cost per patient was €11 060 in the stent group and €4 787 in the control group, resulting in a difference of €6 273 per patient between the groups. The difference in mean QALYs between the groups was 0.26, in favour of the stent group, which resulted in an incremental cost effectiveness ratio (ICER) of € 23 785 per QALY. CONCLUSION: The costs associated with primary stenting in the SFA for the treatment of IC were higher than for exercise advice and BMT alone. With concurrent improvement in health related quality of life, primary stenting was a cost effective treatment option according to the Swedish national guidelines (ICER < €50 000 - €70 000) and approaching the UK's National Institute for Health and Care Excellence threshold for willingness to pay (ICER < £20 000 - £30 000). From a cost effectiveness standpoint, primary stenting of the SFA can, in many countries, be used as an adjunct to exercise training advice, but it must be considered that successful implementation of structured exercise programmes and longer follow up may alter these findings.

Intraprocedural Transcutaneous Oxygen Pressure and Systolic Toe Pressure Measurements During and After Endovascular Intervention in Patients with Chronic Limb Threatening Ischaemia.

OBJECTIVE: The aim of this study was to evaluate changes in transcutaneous oxygen pressure (tcpO2) and systolic toe pressure (TP) during endovascular intervention. METHODS: This was a single centre prospective, non-randomised, observational feasibility study. Patients with chronic limb threatening ischaemia (CLTI) due to infrainguinal disease scheduled for endovascular treatment were included between March 2018 and December 2019. TcpO2 was measured continuously bilaterally at foot level throughout the procedure and at follow up. Specific time points during the intervention were chosen for comparison to baseline (before arterial puncture): average tcpO2 level five minutes prior to percutaneous transluminal angioplasty (PTA); 10 minutes after PTA; and at completion. Bilateral TP was recorded using laser Doppler flowmetry before arterial puncture, at completion, and at clinical follow up. Angiograms were analysed for successful revascularisation and vascular lesions classified according to the Global Limb Anatomical Scoring System (GLASS). Rutherford and WIfI (Wound, Ischaemia, and foot Infection) classifications were registered, as well as clinical outcome. RESULTS: Twenty-one patients completed the study. Completion angiograms showed inline flow to the foot in all but two patients. Median time to follow up was 10 weeks (range 8 - 13 weeks) and all patients except one improved clinically. TcpO2 decreased during the initial stage of the intervention, from before arterial puncture to five minute average before PTA (p < .001) and did not recover to above baseline values at the end of intervention. TcpO2 increased significantly at follow up (p < .001). TP increased statistically significantly during intervention (p < .001) and at follow up (p < .001) compared with baseline. CONCLUSION: TcpO2 and TP measurements are safe and feasible non-invasive techniques for haemodynamic monitoring during endovascular revascularisation. TP increased significantly immediately after completion of the successful intervention, whereas tcpO2 did not. Both TP and tcpO2 demonstrated a significant increase at the 10 week follow up.

Reliable and valid assessment of procedural skills in resuscitative endovascular balloon occlusion of the aorta.

BACKGROUND: Valid and reliable assessment of skills is essential for improved and evidence-based training concepts. In a recent study, we presented a novel tool to assess procedural skills in resuscitative endovascular balloon occlusion of the aorta (REBOA), REBOA-RATE, based on international expert consensus. Although expert consensus is a strong foundation, the performance of REBOA-RATE has not been explored. The study aimed to examine the reliability and validity of REBOA-RATE. METHODS: This was an experimental simulation-based study. We enrolled doctors with three levels of expertise to perform two REBOA procedures in a simulated scenario of out-of-hospital cardiac arrest. Procedures were video-recorded, and videos were blinded and randomized. Three clinical experts independently rated all procedures using REBOA-RATE. Data were analyzed using Messick's framework for validity evidence, including generalizability analysis of reliability and determination of a pass/fail standard. RESULTS: Forty-two doctors were enrolled: 16 novices, 13 anesthesiologists, and 13 endovascular experts. They all performed two procedures, yielding 84 procedures and 252 ratings. The REBOA-RATE assessment tool showed high internal consistency (Cronbach's α = 0.95) and excellent interrater reliability (intraclass correlation coefficient, 0.97). Assessment using one rater and three procedures could ensure overall reliability suitable for high-stakes testing (G-coefficient >0.80). Mean scores (SD) for the three groups in the second procedure were as follows: novices, 32% (24%); anesthesiologists, 55% (29%); endovascular experts, 93% (4%) (p < 0.001). The pass/fail standard was set at 81%, which all experts but no novices passed. CONCLUSION: Data strongly support the reliability and validity of REBOA-RATE, which successfully discriminated between all experience levels. The REBOA-RATE assessment tool requires minimal instruction, and one rater is sufficient for reliable assessment. Together, these are strong arguments for the use of REBOA-RATE to assess REBOA skills, allowing for competency-based training and certification concepts. LEVEL OF EVIDENCE: Diagnostic test, no or poor gold standard, level V.

Patients' perspective on prostatic artery embolization: A qualitative study.

OBJECTIVES: The aim was to describe the patients' experience of undergoing prostatic artery embolization. METHODS: A retrospective qualitative interview study was undertaken with 15 patients of mean age 73 years who had undergone prostatic artery embolization with a median duration of 210 min at two medium sized hospitals in Sweden. The reasons for conducting prostatic artery embolization were clean intermittent catheterization (n = 4), lower urinary tract symptoms (n = 10) or haematuria (n = 1). Data were collected through individual, semi-structured telephone interviews 1-12 months after treatment and analysed using qualitative content analysis. RESULTS: Four categories with sub-categories were formulated to describe the results: a diverse experience; ability to control the situation; resumption of everyday activities and range of opinions regarding efficacy of outcomes. Overall, the patients described the procedure as painless, easy and interesting and reported that while the procedure can be stressful, a calm atmosphere contributed to achieving a good experience. Limitations on access to reliable information before, during and after the procedure were highlighted as a major issue. Practical ideas for improving patient comfort during the procedure were suggested. Improved communications between treatment staff and patients were also highlighted. Most patients could resume everyday activities, some felt tired and bruising caused unnecessary worry for a few. Regarding functional outcome, some patients described substantial improvement in urine flow while others were satisfied with regaining undisturbed night sleep. Those with less effect were considering transurethral resection of the prostate as a future option. Self-enrolment to the treatment and long median operation time may have influenced the results. CONCLUSIONS: From the patients' perspective, prostatic artery embolization is a well-tolerated method for treating benign prostate hyperplacia.

Endovascular Relining of Chronically Occluded Infrainguinal Venous Bypass Grafts.

BACKGROUND: Treatment of chronically occluded infrainguinal venous bypass grafts in patients presenting with recurrent chronic limb threatening limb ischemia (CLTI) represent a clinical challenge. Recent case reports have suggested the use of endovascular recanalization techniques without preceding thrombolysis. This study assesses feasibility and mid-term outcomes of this technique. RESULTS: A retrospective review of 5 consecutive patients (3 men, 2 women, mean age 70 ± 5 years) presenting with chronic venous bypass graft occlusion and recurrence of CLTI during 1 year was performed. Patients were treated with relining of the bypass grafts. Patients were followed up at median 26 (6-36) months. All patients were treated successfully with restoration of flow in the grafts using recanalization and relining technique without thrombolysis. In 4 patients, a Viabahn stentgraft (SG) was used with the addition of interwoven nitinol stents (INS) in 3. In 1 patient, the graft was treated with INS without the addition of a stentgraft. No peripheral embolization was encountered during the procedures. One patient occluded the relined grafts after 6 months. The remaining 4 grafts were all patent at 24-month follow-up. A total of 6 reinterventions (in 3 patients) were performed to reach 80% secondary patency. CONCLUSIONS: This case series demonstrate feasibility and promising mid-term results, from relining of chronically occluded infra-inguinal venous bypass grafts using stent grafts, interwoven and bare-metal stents without preceding thrombolysis. The technique could be an alternative treatment option in the treatment of these challenging cases.

Pseudoaneurysm Development after Drug-Eluting Balloon (DEB) Angioplasty of a Venous Femoropopliteal Bypass Graft.

Endovascular recanalization of occluded venous femoropopliteal bypass grafts is widely used because of easy access. This case report describes pseudoaneurysm developing 4 weeks after endovascular recanalization of an occluded in situ venous femoropopliteal graft. The patient was treated for a popliteal aneurysm with a venous femoropopliteal bypass graft, which subsequently occluded. Four weeks after DEB PTA, the occluded graft developed 3 pseudoaneurysms. Impaired vessel wall healing after intraluminal paclitaxel administration could have contributed to this. This case adds a perspective to the choice of treatment of occluded venous femoropopliteal bypass grafts.

Mortality with Paclitaxel-Coated Devices in Peripheral Artery Disease.

BACKGROUND: The results of a recent meta-analysis aroused concern about an increased risk of death associated with the use of paclitaxel-coated angioplasty balloons and stents in lower-limb endovascular interventions for symptomatic peripheral artery disease. METHODS: We conducted an unplanned interim analysis of data from a multicenter, randomized, open-label, registry-based clinical trial. At the time of the analysis, 2289 patients had been randomly assigned to treatment with drug-coated devices (the drug-coated-device group, 1149 patients) or treatment with uncoated devices (the uncoated-device group, 1140 patients). Randomization was stratified according to disease severity on the basis of whether patients had chronic limb-threatening ischemia (1480 patients) or intermittent claudication (809 patients). The single end point for this interim analysis was all-cause mortality. RESULTS: No patients were lost to follow-up. Paclitaxel was used as the coating agent for all the drug-coated devices. During a mean follow-up of 2.49 years, 574 patients died, including 293 patients (25.5%) in the drug-coated-device group and 281 patients (24.6%) in the uncoated-device group (hazard ratio, 1.06; 95% confidence interval, 0.92 to 1.22). At 1 year, all-cause mortality was 10.2% (117 patients) in the drug-coated-device group and 9.9% (113 patients) in the uncoated-device group. During the entire follow-up period, there was no significant difference in the incidence of death between the treatment groups among patients with chronic limb-threatening ischemia (33.4% [249 patients] in the drug-coated-device group and 33.1% [243 patients] in the uncoated-device group) or among those with intermittent claudication (10.9% [44 patients] and 9.4% [38 patients], respectively). CONCLUSIONS: In this randomized trial in which patients with peripheral artery disease received treatment with paclitaxel-coated or uncoated endovascular devices, the results of an unplanned interim analysis of all-cause mortality did not show a difference between the groups in the incidence of death during 1 to 4 years of follow-up. (Funded by the Swedish Research Council and others; ClinicalTrials.gov number, NCT02051088.).

Eight-year outcome after invasive treatment of infrainguinal intermittent claudication: A population-based analysis from the Swedish vascular register (Swedvasc).

OBJECTIVES: Invasive treatment of infrainguinal intermittent claudication is controversial, and long-term outcomes are scarce. The study aim was to evaluate 8 years results regarding new vascular interventions on index and contralateral limb, hospitalization, mortality, and amputation in 775 patients revascularized for infrainguinal intermittent claudication in 2009. METHODS: Data on new vascular interventions retrieved from the Swedish vascular register (Swedvasc) were linked to the Inpatient Register and Cause of Death Register with information on hospitalizations, primary discharge diagnoses according to the 10th revision of the International Statistical Classification of Diseases and Related Health Problems (ICD-10), deaths, causes of death, and amputations. RESULTS: During 8 years of follow-up, 486 new vascular interventions were performed. Patients were admitted for a total of 4662 hospitalizations and spent 25,970 days in hospital. Between 79% and 99% of surviving subjects were hospitalized each year. During follow-up, 311 (40.1%) patients died. The most common causes of hospitalization and death were cerebrovascular disease, ischemic heart disease, or other diseases of the circulatory system, causing 47.5% of hospitalizations and 42.4% of deaths. Seventy-seven major lower limb amputations were performed in 52 patients. CONCLUSION: As patients undergoing invasive treatment of infrainguinal intermittent claudication have high morbidity and mortality, during 8 years of follow-up, the indication for invasive treatment should be carefully weighed against concomitant comorbidities and the timing of this treatment optimized with regard to the patient's possibilities to enjoy positive treatment effects on quality of life.

2D perfusion-angiography during endovascular intervention for critical limb threatening ischemia - A feasibility study.

PURPOSE: Two-dimensional perfusion angiography is a new method to quantify and evaluate tissue perfusion during endovascular intervention. The aim was to evaluate time-patterns and dynamics of contrast arrival and distribution before and after endovascular intervention in patients with critical limb threatening ischemia. METHODS: Data were collected from 37 patients with critical limb threatening ischemia due to infra-inguinal occlusive disease having a successful endovascular procedure. two-dimensional perfusion angiography was used as a post-processing software with analysis of numeric parameters related to arrival and distribution patterns of contrast. RESULTS: Thirty-three patients were successfully analysed whereas four patients were excluded due to motion artefacts. All patients were successfully treated with recanalization of the superficial femoral, popliteal, below the knee-vessels or a combination. Short-term improvement at 30-day follow-up was noted both clinically and by ankle-brachial index and toe pressure measurements. A significant reduction in contrast arrival time between pre-and post-angioplasty runs was noted as measured by arrival time median 3.2 and interquartile range (2.5-4.2) vs. 2.6 (1.6-3.4) and time-to-peak 4.1 (3.6-5.0) vs. 3.1 (2.3-3.9) p = 0.009. An increased wash-in rate was also observed 18.3 (12.6-21) vs. 30.1 (22-30.5) p = 0.001 between pre-and post-angioplasty runs. CONCLUSIONS: The use of perfusion angiography for evaluation of foot-circulation during endovascular interventions provides new information regarding quantitative assessment of contrast inflow before and after endovascular intervention without the need for extra contrast or runs. No selective catheterisation is necessary. The technique is easily adopted in a clinical setting. Further studies are necessary to create robust clinical endpoints.

Introduction of prostate artery embolization (PAE) in Sweden.

Background: Transurethral resection of the prostate (TURP) is 'Gold Standard' treatment for moderate-to-severe lower urinary tract symptoms (LUTS) due to benign prostate hyperplasia (BPH) with bladder-outlet obstruction (BOO). However, TURP is associated with a risk of complications, so minimally invasive methods have been developed. Prostate artery embolization (PAE) is a new minimally invasive procedure. This study reports the outcomes of PAE when introduced in a 'real life' clinical setting in a Swedish County hospital. Methods: A prospective, single-center, single-arm study in a consecutive vascular-anatomy 'all comers' population, eligible for TURP or adenomaenukleation, but unsuitable for this, treated with PAE from January 2015 to June 2018. Defined improvement of IPSS/QoL scores, or freedom from urinary catheter if previous urinary catheter-dependent, or clean intermittent catheterization (CIC) were considered as clinically successful treatments. PAE was performed until arterial stasis using the Perfected technique. Most patients were treated during a day-care procedure. Results: Of 37 treated men, bilateral PAEs were achieved in 32 patients, unilateral PAEs in four patients, and bilateral failure in one patient due to difficult vascular anatomy. Clinically successful treatment was achieved in 84%, without serious adverse events. Conclusions: PAE was introduced in Sweden, showing PAE as a novel and good minimally invasive alternative in treatment of symptomatic BPH, possible to perform as a day-care procedure.

Onyx Embolization for Occlusion of the Proximal Internal Iliac Artery During EVAR in Patients with Unsuitable Landing Zones in the Common Iliac Artery.

BACKGROUND: Twenty percent of the patients with AAA have an aneurysm involving the common iliac arteries. Large common iliac diameter can be treated with an iliac branched device or extension of the stent graft to the external iliac artery with occlusion of the ipsilateral internal iliac artery (IIA) to prevent type 2 endoleaks. This study describes and evaluates a embolization technique using Onyx in conjunction with EVAR in aneurysms with poor landing zones in the common iliac arteries. METHODS: Patients with Onyx IIA embolization during EVAR, identified from the hospital operating code database, constitute the study population. Onyx embolization was performed by injection at the IIA origin. Peri- and postoperative complications were collected from the medical records. Thin-sliced CT scan was performed 1 month and 1 year after the procedure. RESULTS: Thirty-six patients with complex iliac anatomy and insufficient landing zones (without sealing possibility for standard stent grafts) were identified out of 243 consecutive EVAR treatments during a 13-year period. In seventeen patients (7%), the IIA was embolized with Onyx. Technical success was obtained in all 17 patients, without adverse event or procedural complication. No complication related to the embolization procedure was noted during follow-up. CONCLUSIONS: During EVAR treatment of patients with aneurysm involving the common iliac artery, Onyx embolization of IIA is a feasible option without need of selective catheterization of the IIA orifice, potentially preserving important branches of the IIA and simplifying emergency procedures.

Assessment of EVAR Competence: Validity of a Novel Rating Scale (EVARATE) in a Simulated Setting.

OBJECTIVES: The aims of this study were to investigate the validity evidence for a novel procedure specific assessment tool of competence in endovascular aortic repair (EVAR) and to establish a pass/fail level for the assessment. METHODS: Computed tomography angiography data of a 55 mm in diameter infrarenal aortic aneurysm was implemented into an endovascular simulator. Twenty-three physicians with varying EVAR experiences were video-recorded when performing a standard EVAR procedure on the simulator. Two experienced EVAR operators assessed the participants using the novel rating scale, "EndoVascular Aortic Repair Assessment of Technical Expertise" (EVARATE). Validity was studied according to the framework endorsed by the American Educational Research Association. RESULTS: The EVARATE scale had a high internal consistency (Cronbach's alpha = .90). The inter-rater reliability was acceptable (Intraclass Correlation Coefficient = .68, p = .005). Specific EVAR experience correlated significantly with the EVARATE score (Spearman's rho = .62, p = .002), but general endovascular experience did not. Consequence analysis showed that the EVARATE assessment could distinguish novices from intermediates (p < .01) and from experts (p < .001). A pass/fail score was determined using the contrasting groups' method. CONCLUSION: This paper presents the initial validity evidence for a novel procedure specific assessment tool, EVARATE, for operator competence in endovascular aortic repair investigated in a simulated setting. The assessment tool can be used to provide structured formative feedback to trainees.

Primary Stenting of the Superficial Femoral Artery in Patients with Intermittent Claudication Has Durable Effects on Health-Related Quality of Life at 24 Months: Results of a Randomized Controlled Trial.

BACKGROUND: Intermittent claudication (IC) is commonly caused by lesions in the superficial femoral artery (SFA), yet invasive treatment is still controversial and longer term patient-reported outcomes are lacking. This prospective randomized trial assessed the 24-month impact of primary stenting with nitinol self-expanding stents compared to best medical treatment (BMT) alone in patients with stable IC due to SFA disease on health-related quality of life (HRQoL). METHODS: One hundred patients with stable IC due to SFA disease treated with BMT were randomized to either stent (n = 48) or control (n = 52) group. HRQoL assessed by Short Form 36 Health Survey (SF-36) and EuroQoL 5-dimensions (EQ5D) 24 months after treatment were primary outcome measures. Walking Impairment Questionnaire, ankle-brachial index (ABI), and walking distance were secondary outcomes. RESULTS: Significantly better SF-36 Physical Component Summary (P = 0.024) and physical domain scores such as Physical Function (P = 0.012), Bodily Pain (P = 0.002), General Health (P = 0.037), and EQ5D (P = 0.010) were reported in intergroup comparison between the stent and the control group. Both ABI (from 0.58 ± 0.11 to 0.85 ± 0.18; P < 0.001 in the stent group and from 0.63 ± 0.17 to 0.69 ± 0.18; P = 0.036 in the control group) and walking distance (from 170 ± 90 m to 616 ± 375 m; P < 0.001 in the stent group and from 209 ± 111 m to 331 ± 304 m; P = 0.006 in the control group) improved significantly in intragroup comparisons. CONCLUSIONS: In patients with IC caused by lesions in the SFA, primary stenting compared to BMT alone was associated with significant improvements in HRQoL, ABI, and walking distance durable up to 24 months of follow-up. Clinical Trial Registration http://www.clinicaltrials.gov . Unique Identifier: NCT01230229.

Patients With Intermittent Claudication and Chronic Widespread Pain Improves in Health-Related Quality of Life After Invasive but Not After Noninvasive Treatment.

BACKGROUND: Intermittent claudication (IC) is traditionally managed with risk factor modification, best medical treatment (BMT), and exercise training. Comorbidities such as diabetes and ischemic heart disease affect both results of invasive treatment and health-related quality of life (HRQoL) negatively. It is unknown how chronic widespread pain (CWP) influences the results of invasive treatment. We evaluated the influence of CWP on HRQoL in patients undergoing invasive (open surgery or endovascular treatment) and noninvasive BMT of IC. METHODS: A total of 242 patients with IC treated with invasive or noninvasive methods responded to the validated HRQoL questionnaires Short Form 36 Health Survey, EuroQoL 5-dimensions, and distribution of pain with the Epipain questionnaire at baseline and after 12 months. RESULTS: Invasively treated patients without CWP improved in all primary outcome measures. Patients with CWP reported significant improvements in most of the HRQoL-related outcome measures after invasive treatment, but patients with CWP in the noninvasive treatment group did not improve in any HRQoL-related outcome measure. CONCLUSIONS: The presence of CWP not should be a cause to withhold invasive treatment in patients with IC.

Abdominal injuries in a low trauma volume hospital--a descriptive study from northern Sweden.

BACKGROUND: Abdominal injuries occur relatively infrequently during trauma, and they rarely require surgical intervention. In this era of non-operative management of abdominal injuries, surgeons are seldom exposed to these patients. Consequently, surgeons may misinterpret the mechanism of injury, underestimate symptoms and radiologic findings, and delay definite treatment. Here, we determined the incidence, diagnosis, and treatment of traumatic abdominal injuries at our hospital to provide a basis for identifying potential hazards in non-operative management of patients with these injuries in a low trauma volume hospital. METHODS: This retrospective study included prehospital and in-hospital assessments of 110 patients that received 147 abdominal injuries from an isolated abdominal trauma (n = 70 patients) or during multiple trauma (n = 40 patients). Patients were primarily treated at the University Hospital of Umeå from January 2000 to December 2009. RESULTS: The median New Injury Severity Score was 9 (range: 1-57) for 147 abdominal injuries. Most patients (94%) received computed tomography (CT), but only 38% of patients with multiple trauma were diagnosed with CT < 60 min after emergency room arrival. Penetrating trauma caused injuries in seven patients. Solid organ injuries constituted 78% of abdominal injuries. Non-operative management succeeded in 82 patients. Surgery was performed for 28 patients, either immediately (n = 17) as result of operative management or later (n = 11), due to non-operative management failure; the latter mainly occurred with hollow viscus injuries. Patients with multiple abdominal injuries, whether associated with multiple trauma or an isolated abdominal trauma, had significantly more non-operative failures than patients with a single abdominal injury. One death occurred within 30 days. CONCLUSIONS: Non-operative management of patients with abdominal injuries, except for hollow viscus injuries, was highly successful in our low trauma volume hospital, even though surgeons receive low exposure to these patients. However, a growing proportion of surgeons lack experience in decision-making and performing trauma laparotomies. Quality assurance programmes must be emphasized to ensure future competence and quality of trauma care at low trauma volume hospitals.

Chronic musculoskeletal pain predicted hospitalisation due to serious medical conditions in a 10 year follow up study.

BACKGROUND: The aim was to examine if self reported chronic regional pain (CRP) and chronic widespread pain (CWP) predicted inpatient care due to serious medical conditions such as cerebrovascular diseases, ischemic heart diseases, neoplasms and infectious diseases in a general population cohort over a ten year follow-up period. METHODS: A ten-year follow up of a cohort from the general adult population in two health care districts with mixed urban and rural population in the south of Sweden, that in 1995 participated in a survey on health and musculoskeletal pain experience. Information on hospitalisation for each subject was taken from the regional health care register. Multiple logistic regression analyses were used to study the associations between chronic musculoskeletal pain and different medical conditions as causes of hospitalisation. RESULTS: A report of CRP (OR = 1.6; p < 0.001) or CWP ( OR = 2.1; p < 0.001) predicted at least one episode of inpatient care over a ten year period, with an increased risk in almost all diagnostic subgroups, including cerebrovascular diseases, ischemic heart diseases, and infectious diseases. There was however no increased risk of hospitalisation due to neoplasms. CONCLUSIONS: The presence of especially CWP was associated with hospital inpatient care due to several serious medical disorders. This may imply a general vulnerability to different medical conditions that has to be addressed in the assessment and management of subjects with chronic musculoskeletal pain.