Prognostic Value of Thrombus Volume and Interaction With First-Line Endovascular Treatment Device Choice.

BACKGROUND: A larger thrombus in patients with acute ischemic stroke might result in more complex endovascular treatment procedures, resulting in poorer patient outcomes. Current evidence on thrombus volume and length related to procedural and functional outcomes remains contradicting. This study aimed to assess the prognostic value of thrombus volume and thrombus length and whether this relationship differs between first-line stent retrievers and aspiration devices for endovascular treatment. METHODS: In this multicenter retrospective cohort study, 670 of 3279 patients from the MR CLEAN Registry (Multicenter Randomized Clinical Trial of Endovascular Treatment for Acute Ischemic Stroke in the Netherlands) for endovascularly treated large vessel occlusions were included. Thrombus volume (0.1 mL) and length (0.1 mm) based on manual segmentations and measurements were related to reperfusion grade (expanded Treatment in Cerebral Infarction score) after endovascular treatment, the number of retrieval attempts, symptomatic intracranial hemorrhage, and a shift for functional outcome at 90 days measured with the reverted ordinal modified Rankin Scale (odds ratio >1 implies a favorable outcome). Univariable and multivariable linear and logistic regression were used to report common odds ratios (cORs)/adjusted cOR and regression coefficients (B/aB) with 95% CIs. Furthermore, a multiplicative interaction term was used to analyze the relationship between first-line device choice, stent retrievers versus aspiration device, thrombus volume, and outcomes. RESULTS: Thrombus volume was associated with functional outcome (adjusted cOR, 0.83 [95% CI, 0.71-0.97]) and number of retrieval attempts (aB, 0.16 [95% CI, 0.16-0.28]) but not with the other outcome measures. Thrombus length was only associated with functional independence (adjusted cOR, 0.45 [95% CI, 0.24-0.85]). Patients with more voluminous thrombi had worse functional outcomes if endovascular treatment was based on first-line stent retrievers (interaction cOR, 0.67 [95% CI, 0.50-0.89]; P=0.005; adjusted cOR, 0.74 [95% CI, 0.55-1.0]; P=0.04). CONCLUSIONS: In this study, patients with a more voluminous thrombus required more endovascular thrombus retrieval attempts and had a worse functional outcome. Patients with a lengthier thrombus were less likely to achieve functional independence at 90 days. For more voluminous thrombi, first-line stent retrieval compared with first-line aspiration might be associated with worse functional outcome.

Editor's Choice - Therapeutic Options and Outcomes in Midaortic Syndrome: A Systematic Review and Meta-analysis.

OBJECTIVE: Midaortic syndrome (MAS) is narrowing of the distal thoracic and or abdominal aorta with congenital, inflammatory, or idiopathic aetiology. If left untreated, the prognosis is poor due to hypertensive complications. Follow up data after treatment are sparse, contrary to aortic coarctation. This study aimed to investigate hypertension during follow up after medical, endovascular, and surgical therapy in juveniles and adults. DATA SOURCES: A meta-analysis of case series and reports was performed, focusing on the incidence of hypertension during the follow up of juvenile (i.e., age 0-17 years) and adult MAS patients after medical, endovascular, or surgical therapy. REVIEW METHODS: Search queries were performed in PubMed, Embase, and Web of Science, and eligible articles underwent quality control. Descriptive statistics were reported based on available data, and individual patient data meta-analyses were performed using a one stage approach, accounting for clustering by case series or decades of reporting for case reports. For the meta-analysis, missing outcome and aetiology data were multiply imputed. RESULTS: The number of juveniles and adults who underwent endovascular therapy (33.7% vs. 27.3%; p = .42) and surgery (52.2% vs. 58.0%; p = .46) was similar. At baseline, 92.4% of juveniles and 87.5% of adults were hypertensive, decreasing to 23.2% and 24.1% during a follow up of 23 months (juveniles) and 18 months (adults), respectively. More hypertension was found compared with surgery in juveniles after endovascular therapy (38.1% vs. 10.8%; p = .020). Meta-analysis also demonstrated a trend for hypertension after endovascular therapy in juveniles, whereas hypertension was more prevalent following surgery in adults compared with endovascular therapy or medication. CONCLUSION: This review and meta-analysis investigated therapeutic options for MAS in juveniles and adults. It found that complications and hypertension during follow up were more common in juveniles after endovascular treatment, whereas surgery in adults was associated with more hypertension.

Improvements in Endovascular Treatment for Acute Ischemic Stroke: A Longitudinal Study in the MR CLEAN Registry.

BACKGROUND: We evaluated data from all patients in the Netherlands who underwent endovascular treatment for acute ischemic stroke in the past 3.5 years, to identify nationwide trends in time to treatment and procedural success, and assess their effect on clinical outcomes. METHODS: We included patients with proximal occlusions of the anterior circulation from the second and first cohorts of the MR CLEAN (Multicenter Randomized Clinical trial of Endovascular Treatment for Acute Ischemic Stroke in the Netherlands) Registry (March 2014 to June 2016; June 2016 to November 2017, respectively). We compared workflow times and rates of successful reperfusion (defined as an extended Thrombolysis in Cerebral Infarction score of 2B-3) between cohorts and chronological quartiles (all included patients stratified in chronological quartiles of intervention dates to create equally sized groups over the study period). Multivariable ordinal logistic regression was used to assess differences in the primary outcome (ordinal modified Rankin Scale at 90 days). RESULTS: Baseline characteristics were similar between cohorts (second cohort n=1692, first cohort n=1488) except for higher age, poorer collaterals, and less signs of early ischemia on computed tomography in the second cohort. Time from stroke onset to groin puncture and reperfusion were shorter in the second cohort (median 185 versus 210 minutes; P<0.001 and 236 versus 270 minutes; P<0.001, respectively). Successful reperfusion was achieved more often in the second than in the first cohort (72% versus 66%; P<0.001). Functional outcome significantly improved (adjusted common odds ratio 1.23 [95% CI, 1.07-1.40]). This effect was attenuated by adjustment for time from onset to reperfusion (adjusted common odds ratio, 1.12 [95% CI, 0.98-1.28]) and successful reperfusion (adjusted common odds ratio, 1.13 [95% CI, 0.99-1.30]). Outcomes were consistent in the analysis per chronological quartile. CONCLUSIONS: Clinical outcomes after endovascular treatment for acute ischemic stroke in routine clinical practice have improved over the past years, likely resulting from improved workflow times and higher successful reperfusion rates.

Follow-up imaging after cryoablation of clear cell renal cell carcinoma is feasible using single photon emission computed tomography with 111In-girentuximab.

PURPOSE: Detection of residual or recurrent vital renal tumor on follow-up (FU) cross-sectional imaging after ablative therapy is challenging. The specific and high expression levels of carbonic anhydrase IX (CAIX) in clear cell renal cell carcinoma (ccRCC) makes it a suitable target for imaging using radiolabeled anti-CAIX antibody girentuximab. The objective of this study was to evaluate the feasibility of targeted FU imaging 1 month after cryoablation of ccRCC using single photon emission computed tomography (SPECT) after 111In-labeled girentuximab administration. METHODS: In this prospective study 16 patients underwent 111In-girentuximab-SPECT before MR-guided renal cryoablation between February 2015 and September 2018. In case of tumor targeting 111In-girentuximab-SPECT was repeated 1 month following MR-guided cryoablation. Presence of residual or recurrent vital tumor was assessed on contrast-enhanced cross-sectional imaging during further FU. The standard FU imaging protocol consisted of MRI/CT scans at 1, 3, 6, 12, and 18 months and annually thereafter. RESULTS: A total of 10 (63%) patients showed positive tumor targeting on 111In-girentuximab-SPECT before cryoablation and 9 ( 56%) were eligible to undergo FU SPECT. Of the 9 111In-girentuximab-SPECT FU scans, 8 (89%) were considered negative. One (11%) scan showed uptake suggestive for residual vital tumor. Six months after treatment, FU CT showed contrast enhancement suggestive for residual/recurrent disease in the ablated zone at the site of the 111In-girentuximab uptake after treatment. During a mean FU of 21 months (range 1-33) no other cases with residual/recurrent disease were detected. CONCLUSION: FU imaging with 111In-girentuximab-SPECT is feasible after ccRCC cryoablation and may contribute to early detection of residual or recurrent disease.

Clinical evaluation of in silico planning and real-time simulation of hepatic radiofrequency ablation (ClinicIMPPACT Trial).

OBJECTIVES: To evaluate the accuracy and clinical integrability of a comprehensive simulation tool to plan and predict radiofrequency ablation (RFA) zones in liver tumors. METHODS: Forty-five patients with 51 malignant hepatic lesions of different origins were included in a prospective multicenter trial. Prior to CT-guided RFA, all patients underwent multiphase CT which included acquisitions for the assessment of liver perfusion. These data were used to generate a 3D model of the liver. The intra-procedural position of the RFA probe was determined by CT and semi-automatically registered to the 3D model. Size and shape of the simulated ablation zones were compared with those of the thermal ablation zones segmented in contrast-enhanced CT images 1 month after RFA; procedure time was compared with a historical control group. RESULTS: Simulated and segmented ablation zone volumes showed a significant correlation (ρ = 0.59, p < 0.0001) and no significant bias (Wilcoxon's Z = 0.68, p = 0.25). Representative measures of ablation zone comparison were as follows: average surface deviation (absolute average error, AAE) with 3.4 ± 1.7 mm, Dice similarity coefficient 0.62 ± 0.14, sensitivity 0.70 ± 0.21, and positive predictive value 0.66 ± 0. There was a moderate positive correlation between AAE and duration of the ablation (∆t; r = 0.37, p = 0.008). After adjustments for inter-individual differences in ∆t, liver perfusion, and prior transarterial chemoembolization procedures, ∆t was an independent predictor of AAE (ß = 0.03 mm/min, p = 0.01). Compared with a historical control group, the simulation added 3.5 ± 1.9 min to the procedure. CONCLUSION: The validated simulation tool showed acceptable speed and accuracy in predicting the size and shape of hepatic RFA ablation zones. Further randomized controlled trials are needed to evaluate to what extent this tool might improve patient outcomes. KEY POINTS: • More reliable, patient-specific intra-procedural estimation of the induced RFA ablation zones in the liver may lead to better planning of the safety margins around tumors. • Dedicated real-time simulation software to predict RFA-induced ablation zones in patients with liver malignancies has shown acceptable agreement with the follow-up results in a first prospective multicenter trial suggesting a randomized controlled clinical trial to evaluate potential outcome benefit for patients.

Focal Salvage MR Imaging-Guided Cryoablation for Localized Prostate Cancer Recurrence after Radiotherapy: 12-Month Follow-up.

PURPOSE: To evaluate safety, quality of life (QoL), and local cancer control after focal salvage MR imaging-guided cryoablation in patients with local recurrence of prostate cancer (PCa) after radiotherapy. MATERIALS AND METHODS: A retrospective, single-center study was performed in 62 patients with radiorecurrent PCa who underwent MR imaging-guided cryoablation since May 2011 with a follow-up ≥12 months in December 2017. Rates and descriptions of adverse events were reported. Ablation complications were classified according to the Clavien and SIR systems. Validated questionnaires were used to observe functional outcomes and QoL before therapy and 6 and 12 months after therapy. Cancer control was defined as no biochemical failure according to Phoenix criteria and no other clinical evidence for local or metastatic disease. RESULTS: All procedures were technically feasible. The number of complications requiring major therapy (Clavien grade 3b/4 or SIR grade D/E/F) was low (2 [3.2%] and 1 [1.6%], respectively). After 12 months, the International Consultation of Incontinence Questionnaire-Short Form (P < .001) and 5-item International Index of Erectile Function (P = .001) scores became significantly worse, indicating increased symptoms of incontinence and diminished erectile function, without compromising QoL. Six patients developed metastases within 6 months. After 12 months, 36 patients (63%) were disease-free. CONCLUSIONS: Focal salvage MR imaging-guided cryoablation is safe and is associated with a high technical success rate, preservation of QoL, and local PCa control. This treatment can be a reasonable alternative to salvage radical prostatectomy in properly selected patients with low morbidity and preservation of QoL; however, longer follow-up is needed.

Improving quality of stroke care through benchmarking center performance: why focusing on outcomes is not enough.

BACKGROUND: Between-center variation in outcome may offer opportunities to identify variation in quality of care. By intervening on these quality differences, patient outcomes may be improved. However, whether observed differences in outcome reflect the true quality improvement potential is not known for many diseases. Therefore, we aimed to analyze the effect of differences in performance on structure and processes of care, and case-mix on between-center differences in outcome after endovascular treatment (EVT) for ischemic stroke. METHODS: In this observational cohort study, ischemic stroke patients who received EVT between 2014 and 2017 in all 17 Dutch EVT-centers were included. Primary outcome was the modified Rankin Scale, ranging from 0 (no symptoms) to 6 (death), at 90 days. We used random effect proportional odds regression modelling, to analyze the effect of differences in structure indicators (center volume and year of admission), process indicators (time to treatment and use of general anesthesia) and case-mix, by tracking changes in tau2, which represents the amount of between-center variation in outcome. RESULTS: Three thousand two hundred seventy-nine patients were included. Performance on structure and process indicators varied significantly between EVT-centers (P < 0.001). Predicted probability of good functional outcome (modified Rankin Scale 0-2 at 90 days), which can be interpreted as an overall measure of a center's case-mix, varied significantly between 17 and 50% across centers. The amount of between-center variation (tau2) was estimated at 0.040 in a model only accounting for random variation. This estimate more than doubled after adding case-mix variables (tau2: 0.086) to the model, while a small amount of between-center variation was explained by variation in performance on structure and process indicators (tau2: 0.081 and 0.089, respectively). This indicates that variation in case-mix affects the differences in outcome to a much larger extent. CONCLUSIONS: Between-center variation in outcome of ischemic stroke patients mostly reflects differences in case-mix, rather than differences in structure or process of care. Since the latter two capture the real quality improvement potential, these should be used as indicators for comparing center performance. Especially when a strong association exists between those indicators and outcome, as is the case for time to treatment in ischemic stroke.

Multiparametric magnetic resonance imaging and follow-up to avoid prostate biopsy in 4259 men.

OBJECTIVE: To determine the proportion of men avoiding biopsy because of negative multiparametric magnetic resonance imaging (mpMRI) findings in a prostate MRI expert centre, and to assess the number of clinically significant prostate cancers (csPCa) detected during follow-up. PATIENTS AND METHODS: Retrospective study of 4259 consecutive men having mpMRI of the prostate between January 2012 and December 2017, with either a history of previous negative transrectal ultrasonography-guided biopsy or biopsy naïve. Patients underwent mpMRI in a referral centre. Lesions were classified according to Prostate Imaging Reporting And Data System (PI-RADS) versions 1 and 2. Negative mpMRI was defined as an index lesion PI-RADS ≤2. Follow-up until 13 October 2018 was collected by searching the Dutch Pathology Registry (PALGA). Gleason score ≥3 + 4 was considered csPCa. Kaplan-Meier analysis and univariable logistic regression models were used in the cohort of patients with negative mpMRI and follow-up. RESULTS: Overall, in 53.6% (2281/4259) of patients had a lesion classified as PI-RADS ≤2. In 320 patients with PI-RADS 1 or 2, follow-up mpMRI was obtained after a median (interquartile range) of 57 (41-63) months. In those patients, csPCa diagnosis-free survival (DFS) was 99.6% after 3 years. Univariable logistic regression analysis revealed age as a predictor for csPCa during follow-up (P < 0.05). In biopsied patients, csPCa was detected in 15.8% (19/120), 43.2% (228/528) and 74.5% (483/648) with PI-RADS 3, 4 and 5, respectively. CONCLUSION: More than half of patients having mpMRI of the prostate avoided biopsy. In those patients, csPCa DFS was 99.6% after 3 years.

Operator Versus Core Lab Adjudication of Reperfusion After Endovascular Treatment of Acute Ischemic Stroke.

Background and Purpose- The modified Treatment In Cerebral Ischemia (mTICI) score is the standard method to quantify the degree of reperfusion after endovascular treatment in acute ischemic stroke. In clinical practice, it is commonly assessed by local operators after the procedure. In clinical trials and registries, mTICI is evaluated by an imaging core lab. The aim of this study was to compare operator mTICI with core lab mTICI scores in patients included in the MR CLEAN (Multicenter Randomized Clinical Trial of Endovascular Treatment for Acute Ischemic Stroke in the Netherlands) Registry. Methods- All patients with an intracranial carotid or middle cerebral artery occlusion with anteroposterior and lateral digital subtraction angiography runs were included. Operators determined the mTICI score immediately after endovascular treatment. Core lab neuroradiologists were blinded to clinical characteristics and assessed mTICI scores based on pre- and postintervention digital subtraction angiography. The agreement between operator and core lab mTICI scores and their value in the prediction of outcome (score on modified Rankin Scale at 90 days) was determined. Results- In total, 1130 patients were included. The proportion of agreement between operator and core lab mTICI score was 56% (95% CI, 54%-59%). In 33% (95% CI, 31%-36%), mTICI was overestimated by operators. Operators reported a higher rate of successful reperfusion than the core lab (77% versus 67%; difference 10% [95% CI, 6%-14%]; P<0.001). In 252 (33%) of 763 patients scored as incomplete reperfusion by the core lab (mTICI <3), the local read was mTICI 3. Multivariable logistic regression models containing either core lab scored or operator scored successful reperfusion predicted outcome on the full (C statistic of both models: 0.76) or dichotomized modified Rankin Scale (modified Rankin Scale, 0-2; C statistic of both models: 0.83) equally well. Conclusions- Operators tend to overestimate the degree of reperfusion compared with the core lab although this does not affect the accuracy of outcome prediction.

A randomized trial of intraarterial treatment for acute ischemic stroke.

BACKGROUND: In patients with acute ischemic stroke caused by a proximal intracranial arterial occlusion, intraarterial treatment is highly effective for emergency revascularization. However, proof of a beneficial effect on functional outcome is lacking. METHODS: We randomly assigned eligible patients to either intraarterial treatment plus usual care or usual care alone. Eligible patients had a proximal arterial occlusion in the anterior cerebral circulation that was confirmed on vessel imaging and that could be treated intraarterially within 6 hours after symptom onset. The primary outcome was the modified Rankin scale score at 90 days; this categorical scale measures functional outcome, with scores ranging from 0 (no symptoms) to 6 (death). The treatment effect was estimated with ordinal logistic regression as a common odds ratio, adjusted for prespecified prognostic factors. The adjusted common odds ratio measured the likelihood that intraarterial treatment would lead to lower modified Rankin scores, as compared with usual care alone (shift analysis). RESULTS: We enrolled 500 patients at 16 medical centers in The Netherlands (233 assigned to intraarterial treatment and 267 to usual care alone). The mean age was 65 years (range, 23 to 96), and 445 patients (89.0%) were treated with intravenous alteplase before randomization. Retrievable stents were used in 190 of the 233 patients (81.5%) assigned to intraarterial treatment. The adjusted common odds ratio was 1.67 (95% confidence interval [CI], 1.21 to 2.30). There was an absolute difference of 13.5 percentage points (95% CI, 5.9 to 21.2) in the rate of functional independence (modified Rankin score, 0 to 2) in favor of the intervention (32.6% vs. 19.1%). There were no significant differences in mortality or the occurrence of symptomatic intracerebral hemorrhage. CONCLUSIONS: In patients with acute ischemic stroke caused by a proximal intracranial occlusion of the anterior circulation, intraarterial treatment administered within 6 hours after stroke onset was effective and safe. (Funded by the Dutch Heart Foundation and others; MR CLEAN Netherlands Trial Registry number, NTR1804, and Current Controlled Trials number, ISRCTN10888758.).

MRI-guided focal laser ablation for prostate cancer followed by radical prostatectomy: correlation of treatment effects with imaging.

PURPOSE: To correlate treatment effects of MRI-guided focal laser ablation in patients with prostate cancer with imaging using prostatectomy as standard of reference. METHODS: This phase I study was approved by the Institutional Review Board. Three weeks prior to prostatectomy, five patients with histopathologically proven, low/intermediate grade prostate cancer underwent transrectal MRI-guided focal laser ablation. Per patient, only one ablation was performed to investigate the effect of ablation on the tissue rather than the effectiveness of ablation. Ablation was continuously monitored with real-time MR temperature mapping, and damage-estimation maps were computed. A post-ablation high-resolution T1-weighted contrast-enhanced sequence was acquired. Ablation volumes were contoured and measured on histopathology specimens (with a shrinkage factor of 1.15), T1-weighted contrast-enhanced images, and damage-estimation maps, and were compared. RESULTS: A significant volume correlation was seen between the ablation zone on T1-weighted contrast-enhanced images and the whole-mount histopathology section (r = 0.94, p = 0.018). The damage-estimation maps and histopathology specimen showed a correlation of r = 0.33 (p = 0.583). On histopathology, the homogeneous necrotic area was surrounded by a reactive transition zone (1-5 mm) zone, showing neovascularisation, and an increased mitotic index, indicating increased tumor activity. CONCLUSIONS: The actual ablation zone was better indicated by T1-weighted contrast-enhanced than by damage-estimation maps. Histopathology results highlight the importance of complete tumor ablation with a safety margin.

Percutaneous MR-guided focal cryoablation for recurrent prostate cancer following radiation therapy: retrospective analysis of iceball margins and outcomes.

OBJECTIVES: To evaluate iceball margins after magnetic resonance (MR)-guided focal salvage prostate cryoablation and determine the correlation with local outcome. METHODS: A retrospective review was performed on 47 patients that underwent percutaneous MR-guided focal cryoablation for biopsy-proven locally recurrent prostate cancer after primary radiotherapy. Preprocedural diagnostic and intraprocedural MR images were analysed to derive three-directional iceball margins. Local tumour progression after cryoablation was defined as evident tumour recurrence on follow-up MRI, positive MR-guided biopsy or biochemical failure without radiological evidence of metastatic disease. RESULTS: Mean iceball margins were 8.9 mm (range -7.1 to 16.2), 10.1 mm (range 1.1-20.3) and 12.5 mm (range -1.5 to 22.2) in anteroposterior, left-right and craniocaudal direction respectively. Iceball margins were significantly smaller for tumours that were larger (P = .008) or located in the posterior gland (P = .047). Significantly improved local progression-free survival at 1 year post focal cryoablation was seen between patients with iceball margin >10 mm (100%), 5-10 mm (84%) and <5 mm (15%) (P < .001). CONCLUSIONS: Iceball margins appear to correlate with local outcome following MR-guided focal salvage prostate cryoablation. Our initial data suggest that freezing should be applied at minimum 5 mm beyond the border of an MR-visible recurrent prostate tumour for successful ablation, with a wider margin appearing desirable. KEY POINTS: • Shortest iceball margin most often occurred in anteroposterior direction • Margins were smaller in tumours that were larger or posteriorly located • Minimum iceball margin was a predictor of early local tumour progression • A minimum 5-mm margin seems required for effective cryoablation of recurrent PCa.

Percutaneous MR Imaging-Guided Cryoablation of Small Renal Masses in a 3-T Closed-Bore MR Imaging Environment: Initial Experience.

PURPOSE: To assess the feasibility of percutaneous magnetic resonance (MR) imaging-guided cryoablation of small renal masses (SRMs) in a 3-T environment and to evaluate intraprocedural imaging, procedural safety, and initial outcomes. MATERIALS AND METHODS: The analysis included 9 patients (4 men; median age, 72 y; range, 70-82 y) with 9 SRMs (diameter, 12-30 mm). Lesions underwent biopsy, and cryoneedles were inserted under ultrasound guidance. Verification of needle positions and ice-ball monitoring were performed by T1-weighted volumetric interpolated breath-hold examination and T2-weighted half-Fourier acquired single-shot turbo spin-echo sequences. On image analysis, needle positioning was considered appropriate if the target lesion border was visible, the needle tip was inside the target lesion, and the ice ball was expected to cover the target lesion with a 5-mm margin. If these criteria could not be assessed, imaging was considered inadequate. Technical success was defined as tumor coverage with a 5-mm margin and no residual disease on 1-mo follow-up MR imaging. RESULTS: Median total procedure time was 170 min (range, 135-193 min). Intraoperative imaging allowed adequate needle visualization in 67% of acquired scans (4 of 7 T1-weighted and 6 of 8 T2-weighted). Appropriate positioning of two or three needles used for each procedure was confirmed in all cases on T1- or T2-weighted imaging. Ice-ball formation was adequately visualized in all patients. Technical success rate was 100%. No local recurrences were detected on follow-up imaging at a median of 12 mo (range, 3-22 mo). CONCLUSIONS: Percutaneous MR-guided cryoablation of SRMs in a 3-T MR imaging environment is safe and feasible, showing adequate intraoperative imaging capabilities with promising short-term clinical outcomes.

Efficacy and Safety of Aspiration Sclerotherapy of Simple Hepatic Cysts: A Systematic Review.

OBJECTIVE: Aspiration sclerotherapy is a percutaneous procedure indicated for treatment of symptomatic simple hepatic cysts. The efficacy and safety of this procedure have been sources of debate and disagreement for years. The purpose of this study was to assess the long-term efficacy and safety of aspiration sclerotherapy in a systematic review of the literature. MATERIALS AND METHODS: A systematic search was conducted of the electronic databases PubMed MEDLINE, Embase, Web of Science, and the Cochrane Library (until August 2015). Studies of proportional volume or diameter reduction after aspiration sclerotherapy of simple hepatic cysts were included for full-text evaluation. Case reports and case series were excluded. Risk of bias was assessed by use of the Newcastle-Ottawa scale. RESULTS: From 9357 citations, 100 were selected for full-text assessment. We included 16 studies, which included 526 patients with a total of 588 treated cysts. Overall, risk of bias was high, with 12 of 16 studies having a score of poor. Proportional cyst volume reduction ranged between 76% and 100% after a median follow-up period of 1-54 months. Change in symptoms was evaluated in 10 studies: 72-100% of patients reported symptom reduction, and 56-100% reported disappearance. Postprocedural pain occurred most frequently, at a rate of 5-90% among studies. Ethanol intoxication occurred in up to 93% of cases and was reported more frequently in studies with either high ethanol volumes (133.7-138.3 mL) or long sclerotherapy duration (120-180 minutes). CONCLUSION: We found excellent results with respect to long-term efficacy and safety after aspiration sclerotherapy of hepatic cysts. Nevertheless, because of the high risk of bias in the included studies, definite conclusions regarding efficacy cannot be drawn.

Radiofrequency ablation compared to surgical resection for curative treatment of patients with colorectal liver metastases - a meta-analysis.

BACKGROUND: Hepatic resection and ablative treatments, such as RFA are available treatment options for liver tumors. Advantages and disadvantages of these treatment options in patients with colorectal liver metastases need further evaluation. The purpose of this study was to systematically evaluate the role of radiofrequency ablation (RFA) compared to surgery in the curative treatment of patients with colorectal liver metastases (CRLM). METHODS: A systematic search was performed from MEDLINE, EMBASE and the Cochrane Library for studies directly comparing RFA with resection for CRLM, after which variables were evaluated. RESULTS: RFA had significantly lower complication rates (OR = 0.44, 95% CI = 0.26-0.75, P = 0.002) compared to resection. However, RFA showed a higher rate of any recurrence (OR = 1.66, 95% CI = 1.15-2.40, P = 0.007), local recurrence (OR = 9.56, 95% CI = 6.85-13.35, P = 0.001), intrahepatic recurrence (OR = 1.96, 95% CI = 1.34-2.87, P = 0.001) and extrahepatic recurrence (OR = 1.21, 95% CI = 0.90-1.63, P = 0.22). Also, 5-year disease-free survival (OR = 2.20, 95% CI = 1.28-3.79, P = 0.005) and overall survival (OR = 2.35, 95% CI = 1.49-3.69, P = 0.001) were significantly lower in patients treated with RFA. CONCLUSIONS: RFA showed a significantly lower rate of complications, but also a lower survival and a higher rate of recurrence as compared to surgical resection. All the included studies were subject to possible patient selection bias and therefore randomized clinical trials are needed to accurately evaluate these treatment modalities.

Clot Burden Score on Baseline Computerized Tomographic Angiography and Intra-Arterial Treatment Effect in Acute Ischemic Stroke.

BACKGROUND AND PURPOSE: A high clot burden score (CBS) is associated with favorable outcome after intravenous treatment for acute ischemic stroke. The added benefit of intra-arterial treatment might be less in these patients. The aim of this exploratory post hoc analysis was to assess the relation of CBS with neurological improvement and endovascular treatment effect. METHODS: For 499 of 500 patients in the MR CLEAN study (Multicenter Randomized Clinical Trial of Endovascular Treatment for Acute Ischemic Stroke in the Netherlands), the CBS was determined. Ordinal logistic regression models with and without main baseline prognostic variables were used to assess the association between CBS (continuous or dichotomized at CBS of 6) and a shift toward better outcome on the modified Rankin Scale. The model without main baseline prognostic variables only included treatment allocation and CBS. Models with and without a multiplicative interaction term of CBS and treatment were compared using the χ2 test to assess treatment effect modification by CBS. RESULTS: Higher CBS was associated with a shift toward better outcome on the modified Rankin Scale; adjusted common odds ratio per point CBS was 1.12 (95% confidence interval, 1.04-1.20]. Dichotomized CBS had an adjusted common odds ratio of 1.67 (95% confidence interval, 1.12-2.51). Both effect estimates were slightly attenuated by adding baseline prognostic variables. The addition of the interaction terms did not significantly improve the fit of the models. There was a small and insignificant increase of intra-arterial treatment efficacy in the high CBS group. CONCLUSIONS: A higher CBS is associated with improved outcome and may be used as a prognostic marker. We found no evidence that CBS modifies the effect of intra-arterial treatment. CLINICAL TRIAL REGISTRATION: URL: http://www.trialregister.nl. Unique identifier: NTR1804. URL: http://www.controlled-trials.com. Unique identifier: ISRCTN10888758.

Collateral Status on Baseline Computed Tomographic Angiography and Intra-Arterial Treatment Effect in Patients With Proximal Anterior Circulation Stroke.

BACKGROUND AND PURPOSE: Recent randomized trials have proven the benefit of intra-arterial treatment (IAT) with retrievable stents in acute ischemic stroke. Patients with poor or absent collaterals (preexistent anastomoses to maintain blood flow in case of a primary vessel occlusion) may gain less clinical benefit from IAT. In this post hoc analysis, we aimed to assess whether the effect of IAT was modified by collateral status on baseline computed tomographic angiography in the Multicenter Randomized Clinical Trial of Endovascular Treatment of Acute Ischemic Stroke in the Netherlands (MR CLEAN). METHODS: MR CLEAN was a multicenter, randomized trial of IAT versus no IAT. Primary outcome was the modified Rankin Scale at 90 days. The primary effect parameter was the adjusted common odds ratio for a shift in direction of a better outcome on the modified Rankin Scale. Collaterals were graded from 0 (absent) to 3 (good). We used multivariable ordinal logistic regression analysis with interaction terms to estimate treatment effect modification by collateral status. RESULTS: We found a significant modification of treatment effect by collaterals (P=0.038). The strongest benefit (adjusted common odds ratio 3.2 [95% confidence intervals 1.7-6.2]) was found in patients with good collaterals (grade 3). The adjusted common odds ratio was 1.6 [95% confidence intervals 1.0-2.7] for moderate collaterals (grade 2), 1.2 [95% confidence intervals 0.7-2.3] for poor collaterals (grade 1), and 1.0 [95% confidence intervals 0.1-8.7] for patients with absent collaterals (grade 0). CONCLUSIONS: In MR CLEAN, baseline computed tomographic angiography collateral status modified the treatment effect. The benefit of IAT was greatest in patients with good collaterals on baseline computed tomographic angiography. Treatment benefit appeared less and may be absent in patients with absent or poor collaterals. CLINICAL TRIAL REGISTRATION: URL: http://www.trialregister.nl and http://www.controlled-trials.com. Unique identifier: (NTR)1804 and ISRCTN10888758, respectively.

The effect of age on outcome after intra-arterial treatment in acute ischemic stroke: a MR CLEAN pretrial study.

BACKGROUND: In recent randomized controlled trials (RCTs) intra-arterial treatment (IAT) has been proven effective and safe for patients with acute ischemic stroke (AIS). So far, there seemed to be no interaction between older age (>80) and main treatment effect. We studied the association of older age with outcome and adverse events after IAT in a cohort of intra arterially treated patients. METHODS AND FINDINGS: Data from all AIS patients with proven proximal anterior circulation cerebral artery occlusion who were intra arterially treated between 2002 until the start of the MR CLEAN trial were studied retrospectively. Duration of the procedure, recanalization (Thrombolysis In Cerebral Infarction score (TICI)), early neurological recovery (i.e. decrease on NIHSS of ≥ 8 points) after one week or at discharge, good functional outcome at discharge by modified Rankin Scale (mRS ≤ 2) and the occurrence of neurological and non-neurological adverse events were assessed and the association with age was investigated. In total 315 patients met our inclusion criteria. Median age was 63 years (range 22-93) and 17 patients (5.4%) were over 80. Age was inversely associated with good functional outcome (adjusted Odds Ratio (aOR) 0.80, 95% CI: 0.66-0.98) for every 10 years increase of age. Age was not associated with longer duration of the procedure, lower recanalization rate or less early neurological recovery. The risk of all adverse events (aOR 1.27; 95% CI: 1.08-1.50) and non-neurological adverse events (aOR 1.34; 95% CI: 1.11-1.61) increased, but that of peri-procedural adverse events (aOR 0.79; 95% CI: 0.66-0.94) decreased with age. CONCLUSION: Higher age is inversely associated with good functional outcome after IAT in patients with AIS. However, treatment related adverse events are not related to age. These findings may help decision making when considering treatment of older patients with AIS.

Type of anesthesia and differences in clinical outcome after intra-arterial treatment for ischemic stroke.

BACKGROUND AND PURPOSE: Intra-arterial treatment (IAT) in patients with acute ischemic stroke (AIS) can be performed with or without general anesthesia (GA). Previous studies suggested that IAT without the use of GA (non-GA) is associated with better clinical outcome. Nevertheless, no consensus exists about the anesthetic management during IAT of AIS patients. This study investigates the association between type of anesthesia and clinical outcome in a large cohort of patients with AIS treated with IAT. METHODS: All consecutive patients with AIS of the anterior circulation who received IAT between 2002 and 2013 in 16 Dutch hospitals were included in the study. Primary outcome was functional outcome on the modified Rankin Scale at discharge. Difference in primary outcome between GA and non-GA was estimated using multiple ordinal regression analysis, adjusting for age, stroke severity, occlusion of the internal carotid artery terminus, previous stroke, atrial fibrillation, and diabetes mellitus. RESULTS: Three hundred forty-eight patients were included in the analysis; 70 patients received GA and 278 patients did not receive GA. Non-GA was significantly associated with good clinical outcome (odds ratio 2.1, 95% confidence interval 1.02-4.31). After adjusting for prespecified prognostic factors, the point estimate remained similar; statistical significance, however, was lost (odds ratio 1.9, 95% confidence interval 0.89-4.24). CONCLUSIONS: Our study suggests that patients with AIS of the anterior circulation undergoing IAT without GA have a higher probability of good clinical outcome compared with patients treated with general anesthesia.