MRI patient selection for endovascular thrombectomy in acute ischemic stroke: correlation between pretreatment diffusion weighted imaging and outcome scores

Introduction

Eligibility for endovascular treatment (EVT) in patients with acute ischemic stroke (AIS) depends, amongst other factors, on CT- or MR-based scores. The aim of this study was to investigate the role of Alberta Stroke Program Early CT score based on diffusion weighted imaging (MR-ASPECT) in the assessment of brain damage pre-EVT, patient selection for EVT and outcome.

Materials and methods

We included in this study patients with National Institute of Health stroke score (NIHSS) at admission?≥?8, MR-ASPECT?≥?5 and anterior AIS, who were treated with EVT in our hospital. All patients were clinically evaluated at admission, post-EVT, discharge and at 3-month follow-up. We used MR-ASPECT to establish infarct core extension at admission. We evaluated ASPECT score at admission (CT-ASPECT-IN), 24 h after EVT and at discharge, NIHSS, modified Ranking Scale (mRS), Thrombolysis in Cerebral Infarction scale (TICI), onset-to-intervention-delay (OTID) and Collateral Circulation Score (CCS).

Results

68 patients (mean age 78?±?11.9 years) were included in this study. 54.4 and 64.7% of patients had strong clinical improvement after 24 h from EVT and at discharge, respectively. NIHSS evaluated 24 h after EVT correlated with CCS, TICI and OTID. We observed a favourable outcome (mRS 0–2) in 52.9% of patients at 3-month follow-up. MR-ASPECT score correlated with post-EVT outcome better than CT-ASPECT-IN scores.

Conclusion

MR-ASPECT score based on diffusion weighted imaging is useful for the selection of patients with AIS that can have a favourable outcome from EVT. A prompt EVT has huge impact on patient outcome.

     

Endovascular treatment of acute internal carotid artery dissections: technical considerations,clinical and angiographic outcome

Introduction

In acute internal carotid artery dissection (a-ICAD) with concomitant intracranial large vessel occlusion or haemodynamic impairment, the effectiveness of medical treatment is limited and endovascular therapy (EVT) can be considered. Feasibility, safety and outcome of EVT in a-ICAD are not well described yet.

Methods

From an institutional database, we retrospectively selected consecutive patients treated for a-ICAD between January 2007 and July 2015. We assessed recanalization results defining <50 % residual stenosis and mTICI ≥2b as successful. Procedural adverse events and symptomatic haemorrhages were reported as well as clinical outcome at 90 days defining a mRS ≤2 as favourable. Follow-up angiographies were reviewed and retreatments reported.

Results

In the defined period, 73 patients (mean age 48 years (31–73), mean NIHSS 11 (0–27)) received EVT for a-ICAD. The majority (60 %) had tandem occlusions. Cervical artery reconstruction was successful in 100 % and intracranial thrombectomy in 85 %. Thrombus formation (18 %) and thromboembolism (20 %) were the most frequent adverse events but clinically relevant only in 8 %. Symptomatic haemorrhage occurred in 5 %. Clinical outcome was favourable in 64 %, with a lower chance after tandem occlusion (55 vs. 79 %, p = 0.047). Death rate was 10 %. None of the patients developed recurrent ischaemic symptoms, but control angiography revealed abnormal findings of the reconstructed ICA in 38 % leading to retreatment in 17 %.

Conclusion

EVT of a-ICAD is feasible with a predominantly favourable clinical outcome. Improvement of devices and techniques is warranted to reduce the risk of thrombus formation and thromboembolism during treatment and insufficient vessel wall healing thereafter.

     

Efficacy and safety of direct aspiration first pass technique versus stent-retriever thrombectomy in acute basilar artery occlusion—a retrospective single center experience

Introduction

The study aimed to compare efficacy and safety of aspiration thrombectomy (AT) to stentriever thrombectomy (SRT) in patients with basilar artery (BA) occlusion (BAO).

Methods

We retrospectively included patients with the following characteristics: acute BAO or occlusion of the intracranial vertebral artery (ICVA) and endovascular therapy (EVT) with stentriever (SRT) or aspiration thrombectomy (AT). Additional extra- but not intracranial EVT and intravenous thrombolysis (IVT) were allowed.

Results

Between January 2013 and April 2016, 33 patients fulfilled the criteria (13 treated with SRT, 20 with AT). Prior to EVT, 23 (70%) patients received IVT. The proximal intracranial occlusion was ICVA in 2 patients, proximal BA in 5 patients, middle BA in 20 patients, and distal BA in 6 patients. Mean time to treatment was 334 min (95% CI 276–391 min). Procedure duration differed significantly (p = 0.002) as follows: 97 min with SRT (95% CI 69–124 min) and 55 min with AT (95% CI 43–66 min). Recanalization (arterial occlusive lesion (AOL) 2/3) was achieved in 26 patients (79%). Complete recanalization (AOL 3) happened more often with AT (75% (95% CI 65–85%)) compared to SRT (46% (95% CI 32–60%)). Conversion rate 6% (two patients). Hemorrhages occurred in 12 (36%) patients, periprocedural complications in eight (three dissections, five embolizations to new territory) (no group difference). Ten patients (30%) had a favorable outcome (mRS ≤3) at discharge; mortality rate was 24% (eight deaths) (no group difference).

Conclusion

In primarily embolic BAO, aspiration thrombectomy was faster, effective and not detrimental to outcome as compared to stentriever thrombectomy. Thus, it may be justified to use aspiration thrombectomy as first-line treatment in these patients.

     

Prognosis of spontaneous cervical artery dissection and transcranial Doppler findings associated with clinical outcomes

Objectives

We categorised spontaneous cervical artery dissection (sCAD) by radiological features and investigated factors associated with favourable outcomes.

Methods

We retrospectively analysed 128 patients with sCAD with a median follow-up duration of 25 months. Twenty-nine constituted the aneurysm group, 52 the stenotic group, and 47 the occlusive group. Various relevant factors, including National Institute of Health Stroke Scale (NIHSS) scores, type of antithrombotic therapy, stroke progression in the first week, and transcranial Doppler (TCD) flow-waveforms (in the occlusive subgroup) were analysed. Favourable outcomes were defined as a 1-year modified Rankin-Scale score of 0–1. Favourable anatomical outcomes were defined as a reversal of dissection-associated stenosis during follow-up.

Results

The aneurysm and stenotic groups showed favourable outcomes, while the occlusive group outcomes were less favourable. In the stenotic group, anticoagulation, an NIHSS score ≥4, and stroke progression were inversely associated with favourable long-term outcomes. Remarkably, in the occlusive group, flow abnormality more severe than minimal flow was associated with stroke progression, unfavourable long-term outcome, and arterial irreversibility.

Conclusions

The outcome of sCAD depends on its radiological subtype. In the occlusive subtype, which is associated with the worst outcome, TCD flow analysis may predict acute stroke progression and long-term outcome.

Key Points

? Outcomes in cervical artery dissection may be determined by radiological subtypes. ? The aneurysm and stenotic groups had favourable outcomes. ? The occlusive group had less favourable functional outcomes. ? Flow-waveform analysis by TCD could predict functional and anatomical outcomes.

     

Added value of multiphase CTA imaging for thrombus perviousness assessment

Purpose

Thrombus perviousness has been associated with favorable functional outcome in acute ischemic stroke (AIS) patients. Measuring thrombus perviousness on CTA may be suboptimal due to potential delay in contrast agent arrival in occluded arteries at the moment of imaging. Dynamic sequences acquired over time can potentially overcome this issue. We investigate if dynamic CTA has added value in assessing thrombus perviousness.

Methods

Prospectively collected image data of AIS patients with proven occlusion of the anterior or posterior circulation with thin-slice multi-phase CTA (MCTA) and non-contrast CT were co-registered (n = 221). Thrombus attenuation increase (TAI; a perviousness measure) was measured for the arterial, venous, and delayed phase of the MCTA and time-invariant CTAs (TiCTA). Associations with favorable clinical outcome (90-day mRS ≤ 2) were assessed using univariate and multivariable regressions and calculating areas under receiver operating curves (AUC).

Results

TAI determined from the arterial phase CTA was superior in the association with favorable outcome with OR = 1.21 per 10 HU increase (95%CI 1.04–1.41, AUC 0.62, p = 0.014) compared to any other phase (venous 1.14(95%CI 1.01–1.30, AUC 0.58, p = 0.033), delayed 1.046(95%CI 0.919–1.19, AUC 0.53, p = 0.50)), and TiCTA (1.15(95%CI 1.02–1.30, AUC 0.60, p = 0.022). In the multivariable model, only TAI on arterial phase was significantly associated with favorable outcome (aOR 1.59, 95%CI 1.04–2.43, p = 0.032).

Conclusion

Association between TAI with functional outcome was optimal on arterial-phase CTA such that dynamic CTA imaging has no additional benefits in current thrombus perviousness assessment, thereby suggesting that the delay of contrast arrival at the clot is a key variable for patient functional outcome.

     

Length of stay and its impact upon functional outcomes following lower limb arthroplasty

Purpose

The aim was to investigate the interplay between patient characteristics and (1) length of hospital stay and (2) one-year patient-reported outcome following total knee and hip arthroplasty.

Methods

Event (survival) analysis and structural equation modelling were performed for 1001 patients undergoing knee (n = 566) and hip (n = 435) arthroplasty in a single institution.

Results

Age, body mass index and co-morbidities were independent predictors of length of stay in both event analysis and structural equation modelling. These patient characteristics and type of arthroplasty had both small direct and indirect effects on patient-reported outcome measures at one year. Length of stay had a small effect (<2 %) in SF-36 scores at one year.

Conclusion

Predictors that influence length of stay also impact on one-year post-operative outcome and therefore should be taken into account during patient selection and discharge planning.

Level of evidence

Retrospective cohort study, Level III.

     

Clinical outcome of exercise therapy and early post-operative rehabilitation for treatment of neglected Achilles tendon rupture: a randomized study

Purpose

Treatment of neglected Achilles tendon rupture is very challenging. This randomized study aimed to compare the clinical outcome of early post-operative rehabilitation (EPR) with post-operative cast immobilization (PCI).

Methods

Fifty-seven patients with neglected Achilles tendon rupture were randomized to receive EPR (n = 26) or PCI (n = 31) management following surgery. Clinical outcome was monitored by follow-up at weeks 8, 12, 18 and 26 and year 2. The significance of intergroup differences from the Leppilahti scoring system (LSS), ultrasonography, multislice spiral computerized tomography (MSCT) and electromyography was assessed.

Results

Ultrasonography and MSCT revealed no occurrence of tendon elongation or adhesion. Four patients could perform sustained single-leg heel-raise exercise for 60 s at post-operative day 40. The PCI group also showed increased post-operative LSS score, but recovery was slower. Post-operative complications, such as ankle joint ankylosis and osteoporosis, only occurred in the PCI group.

Conclusions

Compared with cast immobilization, early post-operative rehabilitation results in better clinical outcome and faster overall tendon regeneration of neglected Achilles tendon rupture.

Level of evidence

II.

     

Randomized comparison of tape versus semi-rigid and versus lace-up ankle support in the treatment of acute lateral ankle ligament injury

Purpose

Functional treatment is the optimal non-surgical treatment for acute lateral ankle ligament injury (ALALI) in favour of immobilization treatment. There is no single most effective functional treatment (tape, semi-rigid brace or lace-up brace) based on currently available randomized trials.

Methods

This study is designed as a randomized controlled trial to evaluate the difference in functional outcome after treatment with tape versus semi-rigid versus lace-up ankle support (brace) for grades II and III ALALIs. The Karlsson score and the FAOS were evaluated at 6-month follow-up.

Results

One hundred and ninety-three patients (52 % males) were randomized, 66 patients were treated with tape, 58 patients with a semi-rigid brace and 62 patients with a lace-up brace. There were no significant differences in any baseline characteristics between the three groups. Mean age of the patients was 37.3 years (35.1–39.5; SD 15.3). Ninety-five males (49 %) were included. One hundred and sixty-one (59 + 50 + 52) patients completed the study through final follow-up; 32 % lost at follow-up. In two patients treated with tape support, the treatment was changed to a semi-rigid brace because of dermatomal blisters. Except for the difference in Foot and Ankle Outcome Score sport between the lace-up and the semi-rigid brace, there are no differences in any of the outcomes after 6-month follow-up.

Conclusion

The most important finding of current study was that there is no difference in outcome 6 months after treatment with tape, semi-rigid brace and a lace-up brace.

Level of evidence

I.

     

Treatment of septic arthritis of the knee: a comparison between arthroscopy and arthrotomy

Purpose

The aim of this study was to compare the efficacy of arthroscopy and arthrotomy in patients with septic monarthritis of the knee.

Methods

Seventy consecutive patients who underwent surgery because of a bacterial monarthritis were evaluated. Patients were either treated with arthroscopy or with arthrotomy. Our primary outcome was the early recurrence of infection (>3 months after surgery), which made a second surgical procedure necessary. Furthermore, the influence of potential confounders on treatment outcome was analysed.

Results

Of the 70 patients, 41 were treated arthroscopically and 29 with arthrotomy. Eight patients (11.4 %) had to undergo a second surgical procedure because of early re-infection. The rate was significantly higher in patients treated with arthrotomy (n = 6; 20.7 %) compared with those treated by arthroscopy (n = 2) (p = 0.041). Range of motion was significantly better in patients who underwent arthroscopy (p < 0.001). Male sex had negative influence on the treatment success (p = 0.03).

Conclusions

Patients with bacterial monarthritis of the knee who were treated with arthroscopy had a significantly lower re-infection rate and a better functional outcome than those treated with arthrotomy. As arthroscopy is the less invasive method, it should be considered the routine treatment, according to our data.

Level of evidence

Therapeutic study, Level III.

     

Radiofrequency ablation versus magnetic resonance guided focused ultrasound surgery for minimally invasive treatment of osteoid osteoma: a propensity score matching study

Objectives

To compare outcomes in pain relief and motor functional recovery in patients with an osteoid osteoma treated by magnetic resonance guided focused ultrasound surgery (MRgFUS) or radiofrequency ablation (RFA) using a propensity score matching study design.

Methods

Thirty patients with osteoid osteomas were included in this institutional review board (IRB)-approved study. MRgFUS was performed in 15 subjects. These subjects were matched by propensity analysis with a group of 15 subjects treated by RFA. Pain relief in terms of complete response (CR) and motor functional recovery were measured.

Results

A similar proportion of subjects treated by MRgFUS (94 %) or RFA (100 %) experienced CR 12 weeks after treatment, with no significant difference. The improvement in pain control following MRgFUS or RFA paralleled with improved motor functional recovery. The treatment failure rate was 6.6 % in the MRgFUS group and 0 % in the RFA group. No major complications were observed following either ablative treatment.

Conclusions

Although this study involved a limited number of patients, MRgFUS favourably improves perceived pain and motor functional recovery, with no major complications. No difference was found in the achievement of primary and secondary outcome measures with respect to RFA.

Key Points

? To demonstrate the effectiveness of a recent technique for treating osteoid osteoma ? MRgFUS results compared with results of the gold standard treatment (RFA) ? MRgFUS is effective both from a clinical and functional point of view ? No significant side effects compared with RFA

     

Ruptured middle cerebral artery aneurysms with a concomitant intraparenchymal hematoma: the role of hematoma volume

Purpose

To study whether clinical outcome data from our patient cohort could give support to the new recommendation in the AHA/ASA guidelines for the management of aneurysmal subarachnoid hemorrhage that states “that microsurgical clipping may receive increased consideration in patients with ruptured middle cerebral artery (MCA) aneurysms and large (>50 mL) intraparenchymal hematomas”, while clinical outcome data supporting this recommendation are sparse.

Methods

We reviewed the clinical and radiological data of 81 consecutive patients with MCA aneurysms and concomitant hematomas admitted between January 2006 and December 2015. The relation between (semi-automatically quantified) hematoma volume (< or >?50 ml), neurological condition on admission (poor: GCS <?8 or non-reactive pupils), treatment strategies (no treatment, coiling, or clipping with or without decompression and/or clot removal), and outcome (favorable: mRS score 0–3) was evaluated.

Results

Clinical outcome data were available for 76 patients. A significant difference in favorable outcome (17 vs 68%) was seen when comparing patients with poor and good neurological condition on admission (p?<?0.01). Patients with hematomas >?50 ml had similar outcomes for coiling and clipping, all underwent decompression. Patients with hematomas <?50 ml did not show differences in favorable outcome when comparing coiling and clipping with (33 and 31%) or without decompression (90 and 88%).

Conclusion

Poor neurological condition on admission, and not large intraparenchymal hematoma volume, was associated with poor clinical outcome. Therefore, even in patients with large hematomas, the neurological condition on admission and the aneurysm configuration seem to be equally important factors to determine the most appropriate treatment strategy.

     

The Oxford knee score and its subscales do not exhibit a ceiling or a floor effect in knee arthroplasty patients: an analysis of the National Health Service PROMs data set

Purpose

In this study, we examined whether the OKS demonstrated a floor or a ceiling effect when used to measure the outcome of knee replacement surgery in a large national cohort.

Methods

NHS PROMs database, containing pre- to 6 month post-operative OKS on 72,154 patients, mean age 69 (SD 9.4), undergoing knee replacement surgery, was examined to establish the proportion of patients achieving top or bottom OKS values pre- and post-operatively.

Results

Pre-operatively, none of patients achieved the maximum/‘best’ (48) and minimum (0) scores. Post-operatively, no patients (0 %) achieved the minimum/‘worst’ score, but the percentage achieving the maximum score increased to 2.7 %. Subgroup analyses demonstrated that the highest post-operative overall ceiling percentage was 3 %, in a subgroup of patients between 60 and 79 years of age and 13.7 % in a group of patients who had a pre-operative OKS above 41. Furthermore, 10.8 % of patients achieved the top post-operative OKS-PCS and 4.7 % top post-operative OKS-FCS.

Conclusion

Based on NHS PROMs data, the OKS does not exhibit a ceiling or floor effect overall, or for both its pain and function subscales, and remains a valid measure of outcomes for patients undergoing TKA.

Level of evidence

Large-scale retrospective observations study, Level II.

     

Surgical versus conservative management of acute patellar dislocation in children and adolescents: a systematic review

Purpose

The goal of this study was to perform a comparative review to determine whether there is a significant difference in the rate of repeat dislocation and clinical outcome between surgical and conservative management of acute patellar dislocation in children and adolescents.

Methods

A systematic review of the MEDLINE database was performed. English-language clinical outcome studies with a primary outcome/treatment specific to acute patella dislocation in a paediatric population were included. Eleven studies met inclusion criteria; Chi-square analysis, independent t tests and weighted mean pooled cohort statistics were performed where appropriate.

Results

A total of 470 conservatively managed and 157 operatively treated knees were included. Conservatively managed patients were on average 17.0 years and had a mean follow-up of 3.9 years; surgically managed patients were on average 16.1 years and had a mean follow-up of 4.7 years. Conservatively managed knees had a 31 % rate of recurrent dislocation rate compared to 22 % in surgical knees (p = 0.04). Trochlear dysplasia and skeletal immaturity confer greater risk for recurrent instability. Surgical treatment may provide clinically important quality of life and sporting benefit.

Conclusions

Surgical treatment of first time patella dislocation in children and adolescents is associated with a lower risk of recurrent dislocation and higher health-related quality of life and sporting function. There is a paucity of evidence on MPFL reconstruction for first time traumatic patella dislocation in this population.

Level of evidence

IV.

     

The evaluation of non-ischemic dilated cardiomyopathy with T1 mapping and ECV methods using 3T cardiac MRI

Purpose

The aim of this study was to examine the correlation between ventricular function and the extracellular volume fraction (ECV) in patients with non-ischemic dilated cardiomyopathy (NIDCM) using 3.0 T magnetic resonance imaging (MRI). We also hypothesized that native T1 and ECV values would be increased in patients with NIDCM, independent of the left ventricular ejection fraction (LVEF). The findings of our study could lead to further studies of the follow-up protocols.

Materials and methods

In total, 53 consecutive dilated cardiomyopathy patients who had undergone cardiac MRI were functionally evaluated and underwent tissue characterization.

Results

The mean native T1 value was 1235 ± 10 ms, and the mean ECV value was 35.4 ± 2.7% in the myocardia. The LVEF values ranged from 29 to 44%. No significant correlations were observed between functional analysis measurements and native T1 or ECV values.

Conclusions

Our results showed that myocardial fibrosis is unrelated to cardiac functional findings in NIDCM patients. Therefore, we propose that these patients should be evaluated using MRI and tissue characterization techniques, in addition to cardiac functional analysis.

     

Paediatric ACL repair reinforced with temporary internal bracing

Purpose

Instability following non-operative treatment of anterior cruciate ligament (ACL) rupture in young children frequently results in secondary chondral and/or meniscal injuries. Therefore, many contemporary surgeons advocate ACL reconstruction in these patients, despite the challenges posed by peri-articular physes and the high early failure rate. We report a novel management approach, comprising direct ACL repair reinforced by a temporary internal brace in three children.

Methods

Two patients (aged 5 and 6 years) with complete proximal ACL ruptures and a third (aged seven) with an associated tibial spine avulsion underwent direct surgical repair, supplemented with an internal brace that was removed after 3 months.

Results

Second-look arthroscopy, examination and imaging at 3 months confirmed knee stability and complete ACL healing in all cases. Normal activities were resumed at 4 months, and excellent objective measures of function, without limb growth disturbance, were noted beyond 2 years.

Conclusion

ACL repair in young children using this technique negates the requirement and potential morbidity of graft harvest and demonstrates the potential for excellent outcome as an attractive alternative to ACL reconstruction, where an adequate ACL remnant permits direct repair.

Level of evidence

IV.

     

Stent Retriever Thrombectomy in Different Thrombus Locations of Anterior Cerebral Circulation

Background

Mechanical thrombectomy (MT) is a safe and efficient treatment for acute ischemic stroke in patients with proximal anterior occlusion and large penumbra. We evaluated the technical and clinical success of MT in relation to the location of the occlusion (internal carotid artery, M1 and M2 segments of the middle cerebral artery).

Methods

We prospectively reviewed 130 patients of whom 105 met the inclusion criteria. Baseline clinical, procedural and imaging variables, technical outcome (TICI, thrombolysis in cerebral infarction), 24 h imaging outcome and three-month clinical outcome (mRS, modified Rankin Scale) were recorded. Differences between the groups were studied with statistical tests according to the type of the variable.

Results

There were 37, 46 and 22 patients in the internal carotid artery (ICA), M1 and M2 groups, respectively. TICI 2b or 3 was achieved in 92 cases (88 %) with a non-significant trend towards a better recanalization outcome in the ICA and M1 groups. Overall, 57 of the 105 patients (55 %) experienced favorable clinical outcome (mRS ≤ 2) with no significant differences between the groups. Excellent outcome (mRS ≤ 1) was seen in 40 patients (39 %) and there proportionally more patients with excellent outcome in the ICA and M1 groups (ICA: 44 %, M1: 41 %, M2: 23 % of patients, p = 0.22).

Conclusions

There were no statistically significant differences in the technical or clinical outcomes between the different sites of occlusion (ICA, M1 or M2). There was a non-significant trend towards achieving excellent clinical outcome (3-month mRS ≤ 1) more often and better recanalization results in the two more proximal locations.

     

Endovascular treatment of intracranial aneurysms with the p64 flow diverter stent: mid-term results in 35 patients with 41 intracranial aneurysms

Introduction

The p64 flow diverter (FD) device is a fully resheathable and detachable stent dedicated for endovascular treatment (EVT) of intracranial aneurysms (IAs). We report our mid-term experience with this device.

Methods

Between January 2015 and February 2016, we retrospectively identified, in our prospectively maintained database, all patients treated with p64 FDs in two institutions. Independent clinical follow-up was performed by a vascular neurologist. Imaging follow-up included a digitalized subtraction angiography (DSA) at 3, 6, and 12 months and a magnetic resonance angiography (MRA) at 12 months.

Results

Thirty-nine patients (22 women/17 men; median age 54 years) with 48 IAs (median aneurysm size 6.2 mm; mean neck size 3.4 mm) were identified. All IAs were saccular and unruptured. Failure of safe stent delivery occurred in 15% of cases (7/48 IAs) which were excluded. Transient neurological morbidity occurred in 2/35 patients (5.7%) including one delayed thromboembolic complication. No permanent morbidity or mortality was encountered. Complete aneurysmal occlusion at 3, 6, and 12 months was 20/30 (66.6%), 18/27 (66.6%), and 24/28 (85.7%), respectively. Intra-stent stenosis was observed in 9/29 patients (31%) and classified as moderate in 4/29 (13.7%) and mild in 5/29 patients (17.2%). These stenoses gradually improved over time, with only mild stenoses being identified at 6 months and at 12 months.

Conclusion

In our small case series, the p64 FD stent appears safe and effective for EVT of IAs. A high occlusion rate and a low morbidity rate were observed.

     

Long-Term Results from the MAJESTIC Trial of the Eluvia Paclitaxel-Eluting Stent for Femoropopliteal Treatment: 3-Year Follow-up

Purpose

To report the 3-year results of the MAJESTIC first-in-human study of the Eluvia Drug-Eluting Vascular Stent System for treating femoropopliteal artery lesions.

Methods

The prospective, single-arm, multicenter clinical trial enrolled 57 patients with symptomatic lower limb ischemia (Rutherford category 2, 3, or 4) and lesions in the superficial femoral artery or proximal popliteal artery. Mean lesion length was 70.8 ± 28.1 mm, and 46% of lesions were occluded. Efficacy measures at 2 years included primary patency, defined as duplex ultrasound peak systolic velocity ratio of ≤2.5 and the absence of target lesion revascularization (TLR) or bypass. Safety monitoring through 3 years included adverse events and TLR.

Results

Primary patency was estimated as 83.5% (Kaplan–Meier analysis) at 24 months, and 90.6% (48/53) of patients maintained an improvement in Rutherford class. At 36 months, the Kaplan–Meier estimate of freedom from TLR was 85.3%. No stent fractures were identified, and no major target limb amputations occurred.

Conclusion

MAJESTIC results demonstrated long-term treatment durability among patients whose femoropopliteal arteries were treated with the paclitaxel-eluting Eluvia stent.

Level of Evidence

Level 2b, cohort study

     

Arthrotomy versus arthroscopy in the treatment of septic arthritis of the knee in adults: a randomized clinical trial

Purpose

To evaluate the efficacy of treatment and functional recovery of patients diagnosed with septic arthritis of the knee submitted to two surgical techniques: conventional arthrotomy and arthroscopic approach for debridement.

Method

In this prospective clinical study, all adult patients diagnosed with knee pyoarthritis in a 15-month period at a philanthropic hospital in Brazil were randomized into two groups: one group submitted to arthrotomy and the other to arthroscopy. The protocols of antibiotic therapy, physical therapy and postoperative assessment were standardized in both groups. Demographic, clinical, functional and laboratorial variables were compared between groups, with a minimum follow-up of 24 months.

Results

There was no difference in effectiveness of treatment in both groups, but 2 patients (18.2 %) of the arthrotomy group needed a new approach. The pain was higher in those undergoing treatment by arthrotomy, at 7 and 14 days postoperatively. The return to activities of daily living took an average of 5.7 days for both groups: 7.1 days for the arthrotomy group and 4.3 days for arthroscopy group.

Conclusion

It was found that the treatment of knee septic arthritis by both techniques showed similar effectiveness in healing, but the arthroscopy procedure was better than arthrotomy because it has a lower reinfection rate and low initial inflammatory reaction.

Level of evidence

Therapeutic studies, Level I.

     

The association between microhaemorrhages and post - traumatic functional outcome in the chronic phase after mild traumatic brain injury

Purpose

In the chronic phase after mild traumatic brain injury (mTBI), microhaemorrhages are frequently detected on magnetic resonance imaging (MRI). It is however unclear whether microhaemorrhages are associated with functional outcome and which MRI sequence is most appropriate to address this association. We aimed to determine the association between microhaemorrhages and functional outcome in the chronic posttraumatic phase after injury with the most suitable MRI sequence to address this association.

Methods

One hundred twenty-seven patients classified with mTBI admitted to the outpatient clinic from 2008 to 2015 for persisting posttraumatic complaints were stratified according to the presence of MRI abnormalities (n = 63 (MRI+ group) and n = 64 without abnormalities (MRI? group)). For the detection of microhaemorrhages, susceptibility-weighted imaging (SWI) and T2* gradient recalled echo (T2*GRE) were used. The relation between the functional outcome (dichotomized Glasgow Outcome Scale Extended scores) and the number and localization of microhaemorrhages was analysed using binary logistic regression.

Results

SWI detected twice as many microhaemorrhages compared to T2*GRE: 341 vs. 179. Lesions were predominantly present in the frontal and temporal lobes. Unfavourable outcome was present in 67% of the MRI+ group with a significant association of total number of microhaemorrhages in the temporal cortical area on SWI (OR 0.43 (0.21–0.90) p = 0.02), with an explained variance of 44%. The number of microhaemorrhages was not correlated with the number of posttraumatic complaints.

Conclusion

An unfavourable outcome in the chronic posttraumatic phase is associated with the presence and number of microhaemorrhages in the temporal cortical area. SWI is preferably used to detect these microhaemorrhages.