Micro-Lightguide Spectrophotometry (O2C) for Lower Limb Perfusion: Effects of Exercise Walking in Claudicants.

Background Exercise walking has improved walking capacity in patients with intermittent claudication without affecting the macrocirculation reflected in ankle pressures. We wanted to investigate microcirculation in the skin related to exercise walking by using Micro-Lightguide Spectrophotometry (O2C). Materials and Methods Twenty-eight patients with intermittent claudication-bilateral in 17-were included in a 12 weeks of structured home-based exercise program. The pain-free and maximal walking distances were determined on a treadmill. Saturation and flow, monitored by O2C, were examined immediately before and after the treadmill test. O2C examination took place before as well as after completion of the exercise program. Ankle-brachial index was obtained before treadmill testing. Results As expected, walking performance improved significantly without affecting ankle pressures. Neither oxygen saturation nor flow, assessed at 2 mm depth, was affected following a 12 weeks of exercise program. We observed a significant decrease in oxygen saturation and flow upon treadmill testing in the both limbs in patients with bilateral peripheral arterial disease (PAD). In contrast, the treadmill test elicited no changes in the opposite and asymptomatic limb in patients with only unilateral PAD. Conclusion The findings suggest that O2C may be used to study microcirculatory changes. However, it is best suited for the study of phenomena resulting in major changes as it eliminates some inherent variability.

Endovascular aortic repair reduces gluteal oxygenation.

BACKGROUND: Provoked gluteal claudication is a known risk after endovascular aortic repair (EVAR). Lowered gluteal muscle oxygenation (SgmO2) may be demonstrated by near-infrared spectroscopy (NIRS). PURPOSE: To evaluate NIRS-determined SgmO2 in EVAR patients. MATERIAL AND METHODS: NIRS-determined SgmO2 was used in an observational study design (n = 17). From the ambulatory setting, seven EVAR patients were included with reported gluteal claudication from medical records. In 10 patients scheduled for EVAR, SgmO2 was measured before and after the procedure. NIRS sensors were applied bilaterally on the gluteal region. Treadmill walking (12% incline, 2.4 km/h) was introduced to stress gluteal muscles. RESULTS: A reduced SgmO2 with regional side difference (P < 0.05) was noted in all 10 patients following EVAR and four reported gluteal claudication. In patients with gluteal claudication (n = 7), treadmill decreased SgmO2. The time to recover the SgmO2 was prolonged for tissue exposed to occluded hypogastric artery (median = 512 s, range = 73-1207 s vs. median = 137, range = 0-643 s; P = 0.046). CONCLUSIONS: EVAR affects gluteal muscle oxygenation. NIRS could be used to assess whether gluteal claudication is related to lowered SgmO2.

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.

Frequency and Effect of Access-Related Vascular Injury and Subsequent Vascular Intervention After Transcatheter Aortic Valve Replacement.

Vascular access and closure remain a challenge in transcatheter aortic valve replacement (TAVR). This single-center study aimed to report the incidence, predictive factors, and clinical outcomes of access-related vascular injury and subsequent vascular intervention. During a 30-month period, 365 patients underwent TAVR and 333 patients (94%) were treated by true percutaneous transfemoral approach. Of this latter group, 83 patients (25%) had an access-related vascular injury that was managed by the use of a covered self-expanding stent (n = 49), balloon angioplasty (n = 33), or by surgical intervention (n = 1). In 16 patients (5%), the vascular injury was classified as a major vascular complication. Absence of a preprocedural computed tomography angiography (CTA) of the iliofemoral arteries (OR 2.04, p = 0.007) and female gender (OR 2.18, p = 0.004) were independent predictors of the need for access-related vascular intervention. In addition, a high sheath/common femoral artery ratio as measured on preoperative CTA was associated with a higher rate of post-TAVR vascular intervention. The radiation dose, iodine contrast volume, transfusion need, length of hospitalization, and 30-day mortality were not significantly different between patients with versus without access-related vascular intervention. In conclusion, access-related vascular intervention in patients who underwent transfemoral-TAVR is not uncommon. Female gender and a high sheath/common femoral artery ratio are risk factors for access-related vascular injury, whereas preprocedural planning with CTA of the access vessels may reduce the risk of vascular injury. Importantly, most access-related vascular injuries may be treated by percutaneous techniques with similar clinical outcomes to patients without vascular injuries.

Risk Factors for Complications after Peripheral Vascular Surgery in 3,202 Patient Procedures.

BACKGROUND: Complications after open vascular surgery are a major health challenge for the healthcare system and the patients. Infrainguinal vascular surgery is often perceived as less risky than aortic surgery and the aim of this study was to identify which risk factors correlated with postoperative complications after open vascular surgery for infrainguinal occlusive disease in an 8-year cohort using the Danish National Vascular Registry (Karbase), which gathers information on all vascular procedures in Denmark. METHODS: This study is a retrospective cohort study. The Karbase was searched for the predefined procedures from January 1, 2005 through December 31, 2012 at our 2 vascular departments. Both elective and urgent surgeries were included. Complications were defined as wound, surgical, or general complication according to Karbase. RESULTS: Three thousand two hundred two procedures were identified. Median age was 70 years and 21% were octogenarians. Sixty percent were male. There was an overall complication rate of 30%, with 19% being wound complications, 6% surgical, and 10% general complications. The greatest risk factors for developing a complication were high age, cardiac and renal disease, high American Society of Anesthesiologists score, and general anesthetics. The 30-day mortality was 5% (1% for claudicants and 8% for acute ischemia) and the 30-day amputation rate was 7% (0.5% for claudicants and 21% for gangrene). CONCLUSIONS: There is a high risk of complication in peripheral vascular surgery. Risk factors are modifiable or nonmodifiable. It is important to identify the risk factors and treat and optimize the patient cardiac and renal status before surgery if time allows, and also to perform surgery in local or regional anesthesia whenever possible, to reduce the risk of postoperative complications.

Major femoral vascular access complications after coronary diagnostic and interventional procedures: A Danish register study.

BACKGROUND: Vascular access complications after coronary angiography (CAG) and percutaneous coronary intervention (PCI) are known to increase morbidity, prolong hospitalization and raise hospital costs. Therefore, risk factor identification and improvement of safety strategies for vascular management are important. We aimed to assess the incidence of major vascular complications related to femoral access, and to identify potential risk factors. METHODS: Over a period of six years, 23,870 index procedures (CAG) were performed in two centres, prospectively entered in the database and retrospectively analysed. Data was obtained from the Eastern Danish Heart Registry and cross-matched with data from the Danish Vascular Registry. Index procedures were defined as the first trans-femoral procedure. Demographic, procedural and mortality data, as well as information on access complications requiring surgery within 30 days were collected. Mortality data were collected for minimum 12 months. RESULTS: We identified 130 (0.54%) access complications requiring surgery; 65 pseudoaneurysms (0.28%), 46 arterial occlusions (0.19%), 15 hematomas (nine groin and six retroperitoneal hematomas) (0.06%), and 4 arterial dissections (0.02%). Risk factors for complications were left sided femoral access (OR 4.11 [2.29-7.37] p<0.001), peripheral arterial disease (PAD) (OR 2.42 [1.48-3.94] p<0.0001) and female sex (OR 2.22 [1.51-3.24] p<0.0001). CONCLUSION: Vascular complications related to femoral access in coronary diagnostic and interventional procedures are low (0.54%). Risk factors were left sided access, PAD, and female sex.

Endovascular Aneurysm Repair Treatment of Aortoiliac Aneurysms: Can Iliac Branched Devices Prevent Gluteal Claudication?

PURPOSE: To compare the risk of gluteal claudication after endovascular aneurysm repair (EVAR) of aortoiliac aneurysms by interventional exclusion of the internal iliac artery (IIA) with plugs or coils versus a branch iliac device to maintain pelvic blood supply and to identify risk factors for postoperative gluteal claudication. MATERIALS AND METHODS: A retrospective analysis of a prospectively collected data set included patients with aortoiliac aneurysms treated with EVAR from January 2007 to December 2013 at a tertiary referral vascular unit. Descriptive and procedural data were obtained from a database of prospectively enrolled patients. Medical records of 112 consecutive patients treated with EVAR were scrutinized for graft-related adverse events and pelvic ischemia. The occurrence of gluteal claudication was determined from medical records. RESULTS: Iliac occlusion was performed in 115 limbs, and a branch iliac device was placed in 25 limbs. Gluteal claudication developed in 38% of limbs treated with IIA exclusion but in none of the limbs treated with branch iliac devices (P < .001). Procedure time, fluoroscopy time, and use of iodine contrast material did not differ between the two groups. The incidence of gluteal claudication was higher when coils rather than plugs were used for embolization of the IIA before EVAR (P = .002). CONCLUSIONS: The findings suggest that the use of a branch iliac device significantly reduces the risk of gluteal claudication after EVAR of aortoiliac aneurysm.

Perioperative smoking cessation in vascular surgery: challenges with a randomized controlled trial.

BACKGROUND: The effect of intensive smoking cessation programs on postoperative complications has never before been assessed in soft tissue surgery when smoking cessation is initiated on the day of surgery. METHODS: A single-blinded randomized clinical trial conducted at two vascular surgery departments in Denmark. The intervention group was offered the Gold Standard Program (GSP) for smoking cessation intervention. The control group was offered the departments' standard care. Inclusion criteria were patients with planned open peripheral vascular surgery and who were daily smokers. According to the power calculation a total of 144 patients were needed in the trial. RESULTS: Due to slow patient inclusion, the trial was terminated prior to fulfilling the power calculation. Thirty-two patients were included in the trial from March 2011 to September 2012. Of these, 11 were randomized to the GSP intervention and 21 as controls. There was no difference in 30-day complication rates or 6-week abstinence rates between the two groups. CONCLUSIONS: A trial assessing the effect of smoking cessation on postoperative complications on the day of soft tissue surgery is still needed. If another trial is to be planned it must be more pragmatic with less extended inclusion criteria and conducted nationally or internationally to ensure enough patients for the trial. TRIAL REGISTRATION: ClinicalTrials.gov ( NCT01469091 ). Registration date: 27 October 2011.

[Median arcuate ligament syndrome]. / Truncus coeliacus-kompressionssyndrom.

The median arcuate ligament syndrome is a rare entity and poorly described in Danish literature. The syndrome is a diagnosis of exclusion and is characterized by chronic abdominal pain, postprandial pain and weight loss. It is believed that the median arcuate ligament, being a fibrous structure of diaphragm, compresses the coeliac trunk thus causing stenosis and malperfusion of the gastrointestinal organs. Until recently, there has been some reluctance to consider intervention with revascularization or ligament release. Within the latest decade minimally invasive techniques, including laparoscopic release of the median arcuate ligament, have shown promising results.

Mortality and complications after aortic bifurcated bypass procedures for chronic aortoiliac occlusive disease.

OBJECTIVE: Open surgery has given way to endovascular grafting in patients with aortoiliac occlusive disease. The growing use of endovascular grafts means that fewer patients with aortoiliac occlusive disease have open surgery. The declining open surgery caseload challenges the surgeon's operative skills, particularly because open surgery is increasingly used in those patients who are unsuitable for endovascular repair and hence technically more demanding. We assessed the early outcome after aortic bifurcated bypass procedures during two decades of growing endovascular activity and identified preoperative risk factors. METHODS: Data on patients with chronic limb ischemia were prospectively collected during a 20-year period (1993 to 2012). The data were obtained from the Danish Vascular Registry, assessed, and merged with data from The Danish Civil Registration System. RESULTS: We identified 3623 aortobifemoral and 144 aortobiiliac bypass procedures. The annual caseload fell from 323 to 106 during the study period, but the 30-day mortality at 3.6% (95% confidence interval [CI], 3.0-4.1) and the 30-day major complication rate remained constant at 20% (95% CI, 18-21). Gangrene (odds ratio [OR], 3.3; 95% CI, 1.7-6.5; P = .005) was the most significant risk factor for 30-day mortality, followed by renal insufficiency (OR, 2.5; 95% CI, 1.1-5.8; P = .035) and cardiac disease (OR, 2.1; 95% CI, 1.4-3.1; P < .001). Multiorgan failure, mesenteric ischemia, need for dialysis, and cardiac complications were the most lethal complications, with mortality rates of 94%, 44%, 38%, and 34%, respectively. CONCLUSIONS: Aortic bifurcated bypass is a high-risk procedure. Although open surgery has increasingly given way to endovascular repair, 30-day outcomes have remained stable during the past decade. Thus, it is still acceptable to consider an aortic bifurcated bypass whenever endovascular management is not feasible.

[Lower extremity arterial entrapment syndromes]. / Arterielle afklemningssyndromer i underekstremiteterne.

Iliac endofibrosis or iliac kinking and popliteal artery entrapment syndrome are uncommon causes of arterial insufficiency and intermittent claudication in young physically active adults. Diagnostics can be difficult, as the symptoms often are confused with sport injuries and musculoskeletal disorders. Investigation of these patients relies on accurate clinical history and examination as well as both static and dynamic imaging. Early diagnosis and vascular intervention is essential for continued exercise and to prevent thromboembolic complications and, in worst case, limb loss.

The Gold Standard Program for smoking cessation is effective for participants over 60 years of age.

BACKGROUND: Tobacco smoking is more prevalent among the elderly than among the young, and the elderly also have the most frequent contact with the health care system. The aim of this study was to evaluate the effectiveness of the Gold Standard Program, which is an intensive six-week smoking cessation program, on continuous self-reported abstinence rates after six months, on participants over the age of 60 years in a real life setting. METHODS: This was a retrospective cohort study from the national Danish smoking cessation database. RESULTS: The database registered 7369 participants over the age of 60 years (range 60-82) and 24,294 below 60 years (range 15-59). Continuous abstinence rate after six months was 37% for the elderly compared to 35% for the younger (p<0.05). The significant variables for continuous abstinence were: living with another adult (OR 1.10), prior professional recommendation for smoking cessation (OR 1.12), being compliant with program (OR 1.35) and being abstinent at end of course (OR 13.3). CONCLUSIONS: Participants over the age of 60 years had significantly higher continuous abstinence rates after six months than the participants less than 60 years. It is never too late for health professionals to recommend and educate patients about smoking cessation programs even if they are over 60 years of age.

[Medical students' evaluation of clinical departments can help low score departments to improve their effort].

Development of professional identity is essential for medical students to become good doctors. Introduction to the clinical setting, role models, reflection, structure, learning strategy and inclusion in community of practice are important factors. Four observations and 15 interviews were made and revealed big differences in educational practice in four different clinical departments. The departments with low evaluation scores need to improve their practice. Individual guidance inside the department, which adjusts for medical specialty, potentials and challenges, could initiate future progress.

[The assessment of clinical skills is imperative in postgraduate specialty training].

According to the Danish Ministry of Health recommendations, workplace-based assessment (WPBA) should be a central component in postgraduate specialty training. In this review the potential impact of WPBA with regard to patient safety, medical licensing and effects on doctors' learning is explored. The utility of WPBA instruments is reviewed with respect to their reliability, validity, cost, acceptability, and educational impact. Finally, the concept of Entrusted Professional Activities is discussed in view of the utility framework, and recommendations for future practice are provided.

Preoperative methylprednisolone enhances recovery after endovascular aortic repair: a randomized, double-blind, placebo-controlled clinical trial.

OBJECTIVE: To evaluate effects of preoperative high-dose glucocorticoid on the inflammatory response and recovery after endovascular aortic aneurysm repair (EVAR). BACKGROUND: The postimplantation syndrome after EVAR may delay recovery due to the release of proinflammatory mediators. Glucocorticoids may reduce postoperative inflammatory responses and enhance recovery, but with limited information on EVAR. METHODS: A single-center, randomized, double-blind, placebo-controlled trial of 153 patients undergoing elective EVAR between November 2009 and January 2013. Patients received 30 mg/kg of methylprednisolone (MP) (n = 77) or placebo (n = 76) preoperatively. Primary outcome was a modified version of the systemic inflammatory response syndrome. Secondary outcome measures were the effect on inflammatory biomarkers, morbidity, and time to meet discharge criteria. RESULTS: Of 153 randomized patients, 150 (98%) were evaluated for the primary outcome. MP reduced systemic inflammatory response syndrome from 92% to 27% (P < 0.0001) (number needed to treat = 1.5), maximal plasma interleukin 6 from 186 pg/mL [interquartile range (IQR) = 113-261 pg/mL] to 20 pg/mL (IQR = 11-28 pg/mL) (P < 0.001) and fulfillment of discharge criteria was shorter [2 days (IQR = 2-4 days) vs 3 days (IQR = 3-4 days)] (P < 0.001). C-reactive protein, temperature, interleukin 8, and soluble tumor necrosis factor receptor were also reduced (P < 0.001) by MP. Myeloperoxidase, D-dimer, and matrix metalloproteinase 9 were not modified. No differences in 30-day medical (23% vs 36%) (P = 0.1) or surgical (20% vs 21%) morbidity were found in the active group versus the placebo group. CONCLUSIONS: Preoperative MP attenuates the inflammatory response with a faster recovery after EVAR for abdominal aortic aneurysms. Further safety and dose-response studies are required to allow recommendations for general practice. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00989729.

Categorization of aortic aneurysm thrombus morphology by magnetic resonance imaging.

BACKGROUND: Magnetic resonance imaging (MRI) has been proposed for qualitative categorization of intraluminal thrombus morphology. We aimed to correlate the qualitative MRI categorization previously described to quantitative measurements of signal intensity and to compare morphological characteristics of intraluminal thrombus specimens to the appearance on magnetic resonance imaging. METHODS: Thirty-four patients undergoing open surgery for abdominal aortic aneurysm had a preoperative MRI obtained with a 1.5 T magnet. Qualitative categorization was performed (blinded and in consensus) and correlated to intraluminal thrombus to muscle signal-intensity ratios. Morphology of intraluminal thrombus specimens collected during surgery were compared to the magnetic resonance imaging categories and specimen weight was correlated to thrombus volume measured on preoperative computer tomography angiography. RESULTS: Blinded MRI categorization resulted in agreement in 22 out of 34 intraluminal thrombi (Kappa value 0.3, p=0.006). Medians (p=0.004) and distribution (p=0.002) of signal-intensity ratios varied significantly across the three MRI categories obtained by consensus. Heterogeneous and homogenous specimen appearance corresponded to similar appearances on MRI in 78% and 55% respectively, resulting in an overall Kappa=0.4 (p=0.04). Intraluminal thrombus volume and weight correlated well (rs 0.831, p<0.001) with a mean difference of 60 g (95% CI 38-80 g), without proportional bias. CONCLUSION: Qualitative evaluation of intraluminal thrombus morphology based on MRI can be quantified by measuring signal-intensity ratios. Concurrently a fair agreement to blinded qualitative evaluation of thrombus specimens can be obtained. However, the evaluation is impaired by loss of a large proportion of thrombus during sampling.

Popliteal artery entrapment syndrome: ultrasound imaging, intraoperative findings, and clinical outcome.

OBJECTIVES: The purpose of this study was to report our experience with popliteal artery entrapment syndrome (PAES) with special emphasis on the applicability of duplex ultrasound scanning (DUS) when diagnosing PAES. In addition to examining the correlation between DUS and intraoperative findings in symptomatic limbs, the ultrasonic effect of plantar flexion in healthy volunteers were also evaluated. METHODS: During a 12-month period, 11 symptomatic limbs in 8 patients with a mean age of 29 years were referred with suspected PAES and enrolled consecutively. The popliteal artery was studied preoperatively with DUS in rest and during active plantar flexion. The popliteal artery was explored in all symptomatic limbs, and the intraoperative findings served as gold standard. Additionally, the popliteal arteries in 11 healthy volunteers (22 limbs) were evaluated with DUS during rest and plantar flexion. RESULTS: Intraoperative findings confirmed PAES in all 11 symptomatic limbs in accordance with the preoperative DUS examination. Surgical release of the popliteal artery was performed in 11 limbs. At a median follow-up of 15 months, all 11 limbs were free of ischemic symptoms and regained normalized popliteal flow on DUS. In the 22 symptom-free limbs, DUS showed normal popliteal flow during both rest and plantar flexion. CONCLUSIONS: In this series of patients with surgically confirmed PAES, we found preoperative DUS to have perfect agreement with the intraoperative findings in diagnosing PAES. The applicability of the method seems to be emphasized by the restoration of popliteal flow and relief of arterial insufficiency after surgical release in all patients, and by the fact, that none of the healthy volunteers were able to compress the popliteal artery during plantar flexion.

Fine-motor skills testing and prediction of endovascular performance.

BACKGROUND: Performing endovascular procedures requires good control of fine-motor digital movements and hand-eye coordination. Objective assessment of such skills is difficult. Trainees acquire control of catheter/wire movements at various paces. However, little is known to what extent talent plays for novice candidates at entry to practice. PURPOSE: To study the association between performance in a novel aptitude test of fine-motor skills and performance in simulated procedures. MATERIAL AND METHODS: The test was based on manual course-tracking using a proprietary hand-operated roller-bar device coupled to a personal computer with monitor view rotation. A total of 40 test repetitions were conducted separately with each hand. Test scores were correlated with simulator performance. Group A (n = 14), clinicians with various levels of endovascular experience, performed a simulated procedure of contralateral iliac artery stenting. Group B (n = 19), medical students, performed 10 repetitions of crossing a challenging aortic bifurcation in a simulator. RESULTS: The test score differed markedly between the individuals in both groups, in particular with the non-dominant hand. Group A: the test score with the non-dominant hand correlated significantly with simulator performance assessed with the global rating scale SAVE (R = -0.69, P = 0.007). There was no association observed from performances with the dominant hand. Group B: there was no significant association between the test score and endovascular skills acquisition neither with the dominant nor with the non-dominant hand. CONCLUSION: Clinicians with increasing levels of endovascular technical experience had developed good fine-motor control of the non-dominant hand, in particular, that was associated with good procedural performance in the simulator. The aptitude test did not predict endovascular skills acquisition among medical students, thus, cannot be suggested for selection of novice candidates. Procedural experience and practice probably supplant the influence of innate abilities (talent) over time.