Pneumatic dilation and laparoscopic Heller's myotomy (LHM) are established treatments for idiopathic achalasia. Peroral endoscopic myotomy (POEM) is a less invasive therapy with promising early study ...results.
In a multicenter, randomized trial, we compared POEM with LHM plus Dor's fundoplication in patients with symptomatic achalasia. The primary end point was clinical success, defined as an Eckardt symptom score of 3 or less (range, 0 to 12, with higher scores indicating more severe symptoms of achalasia) without the use of additional treatments, at the 2-year follow-up; a noninferiority margin of -12.5 percentage points was used in the primary analysis. Secondary end points included adverse events, esophageal function, Gastrointestinal Quality of Life Index score (range, 0 to 144, with higher scores indicating better function), and gastroesophageal reflux.
A total of 221 patients were randomly assigned to undergo either POEM (112 patients) or LHM plus Dor's fundoplication (109 patients). Clinical success at the 2-year follow-up was observed in 83.0% of patients in the POEM group and 81.7% of patients in the LHM group (difference, 1.4 percentage points; 95% confidence interval CI, -8.7 to 11.4; P = 0.007 for noninferiority). Serious adverse events occurred in 2.7% of patients in the POEM group and 7.3% of patients in the LHM group. Improvement in esophageal function from baseline to 24 months, as assessed by measurement of the integrated relaxation pressure of the lower esophageal sphincter, did not differ significantly between the treatment groups (difference, -0.75 mm Hg; 95% CI, -2.26 to 0.76), nor did improvement in the score on the Gastrointestinal Quality of Life Index (difference, 0.14 points; 95% CI, -4.01 to 4.28). At 3 months, 57% of patients in the POEM group and 20% of patients in the LHM group had reflux esophagitis, as assessed by endoscopy; at 24 months, the corresponding percentages were 44% and 29%.
In this randomized trial, POEM was noninferior to LHM plus Dor's fundoplication in controlling symptoms of achalasia at 2 years. Gastroesophageal reflux was more common among patients who underwent POEM than among those who underwent LHM. (Funded by the European Clinical Research Infrastructure Network and others; ClinicalTrials.gov number, NCT01601678.).
Abstract Background & Aims The recently developed technique of per-oral endoscopic myotomy (POEM) has been shown to be effective for the therapy of esophageal motility disorders. Limited information ...is available about POEM adverse events (AE). Methods POEM was performed with the patients under general anesthesia in 241 patients (58% male, mean age 47.4 ± 16.4 years) during 61 months. Main outcome was the rate of intra- and post-procedural adverse events (AE). Post-procedural checks comprised clinical and laboratory examination, and endoscopy, with further follow-ups being performed at 3, 6 and 12 months, respectively. Results 238 out of 241 procedures (mean procedure time 100.2± 39.5 min) were successfully completed. Reasons for abortion were excessive submucosal fibrosis preventing submucosal tunneling. 3 patients had severe procedural-related adverse events (SAE rate 1.2%); one case of pneumothorax requiring intraprocedural drainage, and two patients with delayed SAE (one ischemic gastric cardia perforation and one hemothorax, both leading to surgery). The overall rate of minor AE was 31.1%, mainly prolonged intraprocedural bleeding (>15 minutes hemostasis) and defects of the mucosa overlying the tunnel; none of them led to clinically relevant signs or symptoms. Patients experiencing any AE had a significant prolonged hospital stay (p=0.037) and a trend toward prolonged procedure time (p=0.094). Neck/upper thoracic emphysema and free abdominal air were noted in 31.5% and 35.7% (95.3% drained), but without relevant sequelae. Conclusions POEM has a low rate of serious adverse events; minor adverse events are more frequent but lack a consistent definition. Therefore, based on our experience and literature analysis, we suggest a classification of AE for POEM.
Pilot studies have indicated that peroral endoscopic myotomy (POEM) might be a safe and effective treatment for achalasia. We performed a prospective, international, multicenter study to determine ...the outcomes of 70 patients who underwent POEM at 5 centers in Europe and North America. Three months after POEM, 97% of patients were in symptom remission (95% confidence interval, 89%–99%); symptom scores were reduced from 7 to 1 ( P < .001) and lower esophageal sphincter pressures were reduced from 28 to 9 mm Hg ( P < .001). The percentage of patients in symptom remission at 6 and 12 months was 89% and 82%, respectively. POEM was found to be an effective treatment for achalasia after a mean follow-up period of 10 months. Clinical Trials Gov Registration number: NCT01405417.
The recently developed technique for peroral endoscopic myotomy (POEM) has been shown to be effective in several short-term studies. Longer term outcome data are largely non-existent.
To ...systematically report clinical outcome with a minimum post-POEM follow-up of 2 years.
All patients treated consecutively by POEM for achalasia at three centres were retrospectively analysed, with a minimum follow-up of 2 years. The main outcome was the rate of POEM failures (Eckardt score >3) related to follow-up time.
Of 85 patients treated, five (5.9%) cases were excluded due to protocol violation or loss to follow-up; the remaining 80 patients (mean age 44.9 years, 54% men) were followed clinically for 29 months (range 24-41). Initial clinical response was observed in 77 cases (96.3%). Clinical recurrences (later failures) were seen in a further 14 cases (17.7%), accounting for a total failure rate of 21.5%. In a multivariate analysis, age and endoscopic reflux signs were independent predictors of treatment success. Of the 17 failures, eight were among the first 10 cases treated in the participating centres. Reflux-associated sequelae included one case of a severe reflux-associated stricture requiring dilatation, and two patients with minor transient Eckardt score elevations curable by proton pump inhibitor (PPI) treatment. Endoscopic signs of reflux oesophagitis, mostly Los Angeles grade A/B, were seen in 37.5% (37/72) at the 2-year control.
In this multicentre retrospective analysis, a high initial success rate of POEM is followed by a mid-term recurrence rate of 18%. Reflux oesophagitis, albeit mild, is frequent and should probably be treated by regular low-dose PPI therapy.
NCT 01405417 (UKE study).
Objective
Early identification of patients at risk of space‐occupying “malignant” middle cerebral artery (MCA) infarction (MMI) is needed to enable timely decision for potentially life‐saving ...treatment such as decompressive hemicraniectomy. We tested the hypothesis that acute stroke magnetic resonance imaging (MRI) predicts MMI within 6 hours of stroke onset.
Methods
In a prospective, multicenter, observational cohort study patients with acute ischemic stroke and MCA main stem occlusion were studied by MRI including diffusion‐weighted imaging (DWI), perfusion imaging (PI), and MR‐angiography within 6 hours of symptom onset. Multivariate regression analysis was used to identify clinical and imaging predictors of MMI.
Results
Of 140 patients included, 27 (19.3%) developed MMI. The following parameters were identified as independent predictors of MMI: larger acute DWI lesion volume (per 1 ml odds ratio OR 1.04, 95% confidence interval CI 1.02–1.06; p < 0.001), combined MCA + internal carotid artery occlusion (5.38, 1.55–18.68; p = 0.008), and severity of neurological deficit on admission assessed by the National Institutes of Health Stroke Scale score (per 1 point 1.16, 1.00–1.35; p = 0.053). The prespecified threshold of a DWI lesion volume >82 ml predicted MMI with high specificity (0.98, 95% CI 0.94–1.00), negative predictive value (0.90, 0.83–0.94), and positive predictive value (0.88, 0.62–0.98), but sensitivity was low (0.52, 0.32–0.71).
Interpretation
Stroke MRI on admission predicts malignant course in severe MCA stroke with high positive and negative predictive value and may help in guiding treatment decisions, such as decompressive surgery. In a subset of patients with small initial DWI lesion volumes, repeated diagnostic tests are required. ANN NEUROL 2010
Summary Background Specialised CT-equipped mobile stroke treatment units shorten time to intravenous thrombolysis in acute ischaemic stroke by starting treatment before hospital admission; however, ...direct effects of pre-hospital thrombolysis on clinical outcomes have not been shown. We aimed to compare 3-month functional outcomes after intravenous thrombolysis in patients with acute ischaemic who had received emergency mobile care or and conventional care. Methods In this observational registry study, patients with ischaemic stroke received intravenous thrombolysis (alteplase) either within a stroke emergency mobile (STEMO) vehicle (pre-hospital care covering 1·3 million inhabitants of Berlin) or within conventional care (normal ambulances and in-hospital care at the Charité Campus Benjamin Franklin in Berlin). Patient data on treatment, outcome, and demographics were documented in STEMO (pre-hospital) or conventional care (in-hospital) registries. The primary outcome was the proportion of patients who had lived at home without assistance before stroke and had a 3-month modified Rankin Scale (mRS) score of 1 or lower. Our multivariable logistic regression was adjusted for demographics, comorbidities, and stroke severity. This study is registered with ClinicalTrials.gov , number NCT02358772. Findings Between Feb 5, 2011, and March 5, 2015, 427 patients were treated within the STEMO vehicle and their data were entered into a pre-hospital registry. 505 patients received conventional care and their data were entered into an in-hospital thrombolysis registry. Of these, 305 patients in the STEMO group and 353 in the conventional care group met inclusion criteria and were included in the analysis. 161 (53%) patients in the STEMO group versus 166 (47%) in the conventional care group had an mRS score of 1 or lower (p=0·14). Compared with conventional care, adjusted odds ratios (ORs) for STEMO care for the primary outcome (OR 1·40, 95% CI 1·00–1·97; p=0·052) were not significant. Intracranial haemorrhage (p=0·27) and 7-day mortality (p=0·23) did not differ significantly between treatment groups. Interpretation We found no significant difference between the proportion of patients with a mRS score of 1 or lower receiving STEMO care compared with conventional care. However, our results suggest that pre-hospital start of intravenous thrombolysis might lead to improved functional outcome in patients. This evidence requires substantiation in future large-scale trials. Funding Zukunftsfonds Berlin, the Technology Foundation Berlin with EU co-financing by the European Regional Development Fund via Investitionsbank Berlin, and the German Federal Ministry for Education and Research via the Center for Stroke Research Berlin.
Objectives
Extracranial stenosis of the internal carotid artery (ICA) is an important cause of ischemic stroke and transient ischemic attack (TIA). It can be diagnosed using contrast-enhanced CT or ...MR angiography (MRA) as well as Doppler ultrasound. In this study, we assessed the diagnostic value of intracranial time-of-flight (TOF) MRA to predict extracranial ICA stenosis (ICAS).
Methods
We retrospectively analyzed consecutive patients with acute ischemic stroke or TIA and middle- (50–69%) or high-grade (70–99%) unilateral extracranial ICAS according to NASCET criteria assessed by ultrasound between January 2016 and August 2018. The control group consisted of patients without extracranial ICAS. Intraluminal signal intensities (SI) of the intracranial ICA on the side of the extracranial stenosis were compared to the contralesional side on TOF-MRA source images. SI ratios (SIR) of contralesional:lesional side were compared between groups.
Results
In total, 151 patients were included in the main analysis. Contralesional:lesional SIR in the intracranial C4-segment was significantly higher in patients with ipsilateral extracranial ICA stenosis (
n
= 51, median 74 years, 57% male) compared to the control group (
n
= 100, median 68 years, 48% male). Mean SIR was 1.463 vs. 1.035 (
p
< 0.001) for right-sided stenosis and 1.362 vs. 1.000 (
p
< 0.001) for left-sided stenosis. Receiver-operating characteristic curve demonstrated a cut-off value of 1.086 for right-sided sensitivity/specificity 75%/81%; area under the curve (AUC) 0.81 and 1.104 for left-sided stenosis (sensitivity/specificity 70%/84%; AUC 0.80) in C4 as a good predictor for high-grade extracranial ICAS.
Conclusions
SIR on TOF-MRA can be a marker of extracranial ICAS.
Objective
Elevated levels of cardiac troponin, and especially their relative changes over time, indicate acute myocardial injury. They are also frequently observed after acute ischemic stroke (AIS), ...indicating poor functional outcome and increased mortality. However, recent evidence showed that, in most AIS patients, myocardial injury is not caused by coronary ischemia. Instead, stroke lesion location has been suggested to precipitate myocardial injury.
Methods
Voxel‐based lesion‐symptom mapping (VLSM) was used in 299 patients who had a magnetic resonance imaging–confirmed acute ischemic stroke within the anterior circulation and a high‐sensitivity cardiac troponin T (hs‐cTnT) acquired on the day of admission. Of these, 228 had a second troponin measurement during the acute phase. The absolute hs‐cTnT levels above the 99th percentile of a healthy reference population (≥14ng/l) as well as their relative temporal changes were used as continuous variables of interest in the VLSM model, including a multiple regression analysis adjusted for confounding variables.
Results
The anterior insular cortex of the right hemisphere, in particular its dorsal subregion, was significantly associated with the relative temporal changes of hs‐cTnT (p < 0.01, corrected for multiple comparisons). In contrast, the baseline hs‐cTnT levels on admission were not related to lesion location anywhere within the anterior circulation.
Interpretation
Our results amplify recent evidence from functional neuroimaging, which suggests a prominent role of dorsal anterior insular cortex in the parasympathetic control of cardiac and autonomic function. Acute vascular damage of this insular subregion might lead to autonomic dysbalance and an upregulation of sympathetic function, thereby resulting in myocardial injury. Ann Neurol 2017;81:502–511
Monitoring cardiac output (CO) is important to optimize hemodynamic function in critically ill patients. The prevalence of aortic valve insufficiency (AI) is rising in the aging population. However, ...reliability of CO monitoring techniques in AI is unknown. The aim of this study was to investigate the impact of AI on accuracy, precision, and trending ability of transcardiopulmonary thermodilution-derived COTCPTD in comparison with pulmonary artery catheter thermodilution COPAC.
Sixteen anesthetized domestic pigs were subjected to serial simultaneous measurements of COPAC and COTCPTD. In a novel experimental model, AI was induced by retraction of an expanded Dormia basket in the aortic valve annulus. The Dormia basket was delivered via a Judkins catheter guided by substernal epicardial echocardiography. High (HPC), moderate (MPC) and low cardiac preload conditions (LPC) were induced by fluid unloading (20 ml kg-1 blood withdrawal) and loading (subsequent retransfusion of the shed blood and additional infusion of 20 ml kg-1 hydroxyethyl starch). Within each preload condition CO was measured before and after the onset of AI. For statistical analysis, we used a mixed model analysis of variance, Bland-Altman analysis, the percentage error and concordance analysis.
Experimental AI had a mean regurgitant volume of 33.6 ± 12.0 ml and regurgitant fraction of 42.9 ± 12.6%. The percentage error between COTCPTD and COPAC during competent valve function and after induction of substantial AI was: HPC 17.7% vs. 20.0%, MPC 20.5% vs. 26.1%, LPC 26.5% vs. 28.1% (pooled data: 22.5% vs. 24.1%). The ability to trend CO-changes induced by fluid loading and unloading did not differ between baseline and AI (concordance rate 95.8% during both conditions).
Despite substantial AI, transcardiopulmonary thermodilution reliably measured CO under various cardiac preload conditions with a good ability to trend CO changes in a porcine model. COTCPTD and COPAC were interchangeable in substantial AI.
Background and purpose
To determine the frequency and distribution pattern of acute DWI lesions outside the hippocampus in patients clinically presenting with Transient Global Amnesia (TGA).
Methods
...Consecutive patients clinically presenting with TGA between January 2010 and January 2017 admitted to our hospital were retrospectively evaluated. All patients fulfilled diagnostic criteria of TGA. We analyzed imaging and clinical data of all patients undergoing MRI with high-resolution diffusion-weighted imaging within 72 h from symptom onset.
Results
A total of 126 cases were included into the study. Fifty-three percent (
n
= 71/126) presented with one or more acute lesions in hippocampal CA1-area. Additional acute DWI lesions in other cortical regions were found in 11% (
n
= 14/126). All patients with DWI lesions outside the hippocampus presented with neurological symptoms typical for TGA (without additional symptoms.)
Conclusions
In a relevant proportion of clinical TGA patients, MRI reveals acute ischemic cerebral lesions. Therefore, cerebral MRI should be performed in patients with TGA to identify a possible cardiac involvement and to detect stroke chameleons.
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