Clinical utility of combined T2-weighted imaging and T2-mapping in the detection of prostate cancer: a multi-observer study

Background: To evaluate the clinical utility of combined T2-weighted imaging and T2-mapping for the detection of prostate cancer. Methods: Forty patients underwent multiparametric magnetic resonance imaging (mpMRI) and T2-mapping of the prostate. Three readers each reviewed two sets of images: T2-weighted fast spin-echo (FSE) sequence (standard T2), and standard T2 in combination with T2-mapping. Each reader assigned probability scores for malignancy to each zone [peripheral zone (PZ) or transition zone (TZ)]. Inter-observer variability for standard T2 and combined standard T2 with T2-mapping were assessed. Diagnostic accuracy was compared between standard T2 and combined standard T2 with T2-mapping. Results: There was fair agreement between all three readers for standard T2 [intraclass correlation coefficient (ICC) =0.56] and combined standard T2 with T2-mapping (ICC =0.58). There was no significant difference in the area under the receiver operator characteristics curve for standard T2 compared to combined standard T2 with T2-mapping (0.89 vs. 0.82, P=0.31). Sensitivity (Sn) for combined standard T2 with T2-mapping was significantly higher compared to standard T2 alone (73.0% vs. 49.2%, P=0.006). Specificity (Sp) for combined standard T2 with T2-mapping was borderline significantly lower compared to standard T2 alone (89.3% vs. 94.9%, P=0.05). There was no significant differences between the negative predictive values (NPVs) and positive predictive values (PPVs) (P=0.07, P=0.45). Conclusions: Combination of T2-weighted imaging and T2-mapping could potentially increase Sn for prostate malignancy compared to T2-weighted imaging alone

Rationale and Design of JenaMACS—Acute Hemodynamic Impact of Ventricular Unloading Using the Impella CP Assist Device in Patients with Cardiogenic Shock

Introduction: Cardiogenic shock due to myocardial infarction or heart failure entails a reduction in end organ perfusion. Patients who cannot be stabilized with inotropes and who experience increasing circulatory failure are in need of an extracorporeal mechanical support system. Today, small, percutaneously implantable cardiac assist devices are available and might be a solution to reduce mortality and complications. A temporary, ventricular, continuous flow propeller pump using magnetic levitation (Impella ® ) has been approved for that purpose. Methods and Study Design: JenaMACS (Jena Mechanical Assist Circulatory Support) is a monocenter, proof-of-concept study to determine whether treatment with an Impella CP ® leads to improvement of hemodynamic parameters in patients with cardiogenic shock requiring extracorporeal, hemodynamic support. The primary outcomes of JenaMACS are changes in hemodynamic parameters measured by pulmonary artery catheterization and changes in echocardiographic parameters of left and right heart function before and after Impella ® implantation at different support levels after 24 h of support. Secondary outcome measures are hemodynamic and echocardiographic changes over time as well as clinical endpoints such as mortality or time to hemodynamic stabilization. Further, laboratory and clinical safety endpoints including severe bleeding, stroke, neurological outcome, peripheral ischemic complications and occurrence of sepsis will be assessed. JenaMACS addresses essential questions of extracorporeal, mechanical, cardiac support with an Impella CP ® device in patients with cardiogenic shock. Knowledge of the acute and subacute hemodynamic and echocardiographic effects may help to optimize therapy and improve the outcome in those patients. Conclusion: The JenaMACS study will address essential questions of extracorporeal, mechanical, cardiac support with an Impella CP ® assist device in patients with cardiogenic shock. Knowledge of the acute and subacute hemodynamic and echocardiographic effects may help to optimize therapy and may improve outcome in those patients. Ethics and Dissemination: The protocol was approved by the institutional review board and ethics committee of the University Hospital of Jena. Written informed consent will be obtained from all participants of the study. The results of this study will be published in a renowned international medical journal, irrespective of the outcomes of the study. Strengths and Limitations: JenaMACS is an innovative approach to characterize the effect of additional left ventricular mechanical unloading during cardiogenic shock via a minimally invasive cardiac assist system (Impella CP ® ) 24 h after onset and will provide valuable data for acute interventional strategies or future prospective trials. However, JenaMACS, due to its proof-of-concept design, is limited by its single center protocol, with a small sample size and without a comparison group

Method comparison for estimating body composition in heart failure patients

Einleitung: Die chronische Herzinsuffizienz (HI) ist eine schwere Systemerkrankung, die auch die Körperzusammensetzung stark beeinflusst. Dies ist gekennzeichnet durch eine vermehrte Flüssigkeitseinlagerung und einer Assoziation sowohl mit Adipositas, als auch mit Kachexie, Muskelschwund und Lipolyse. Die frühzeitige Erkennung von Veränderungen der Körperzusammensetzung ist unerlässlich für eine optimal angepasste medikamentöse Therapie und hat eine hohe prognostische Bedeutung für Patienten, die von einer HI betroffen sind. Die Menge der prospektive Daten über die Körperzusammensetzung bei HI sind derzeit noch gering und die verschiedenen Messverfahren der Körperzusammensetzung wurden für dieses Patientenkollektiv noch nicht direkt miteinander verglichen. Methoden: Für diese monozentrische, nicht interventionelle Beobachtungsstudie wurden 52 symptomatische HI-Ambulanzpatienten (NYHA ≥ II) eingeschlossen, die entweder an einer HI mit reduzierter Ejektionsfraktion (HFrEF, n=31) und einer linksventrikulären Ejektionsfraktion (LVEF) ≤ 40% (nach Simpson) oder an einer HI mit erhaltener Ejektionsfraktion (HFpEF, n=19) und einem enddiastolischen linksatrialen Durchmesser (LAD) ≥ 40mm (parasternal, lange Achse) erkrankt waren. Zum Vergleich wurden 20 gesunde Kontrollpro- banden (REF) ebenfalls untersucht. Die Körperzusammensetzung wurde mittels Dual-energy x-ray absorptiometry (DEXA), Air Displacement Plethysmography (ADP) und bioelektrischer Impedanzspektroskopie (BIS) gemessen. Die Auswertung erfolgte in fünf Gruppen: HI (HFrEF+HFpEF), HFrEF, HFpEF, REF und ALLE (HI+REF). Weiterhin untersuchten wir die Korrelation zwischen Body-Mass-Index (BMI), Waist-to-Hip Ratio (WHR) und Körperdichte (KD) gegenüber der prozentualen Fettmasse (FM[%]). Als Referenzverfahren wurde die DEXA-Messung genommen. Zur Berechnung der Korrelation wurden Lin‘s Concordance Correlation Coefficient (CCC) und Pearson Korrelation (r) anhand der FM[%] genutzt und Bland-Altman- Analysen durchgeführt. Ergebnisse: Bei der ADP errechneten sich für die Konkordanz folgende CCC und (r): HI 0.76 (0.87), HFrEF 0.76 (0.89), HFpEF 0.74 (0.80), REF 0.91 (0.92), ALLE 0.86 (0.89). Für die BIS: HI 0.69 (0.81), HFrEF 0.79 (0.91), HFpEF 0.53 (0.80), REF 0.71 (0.83), ALLE 0.74 (0.88). Der Mittelwert der Differenzen von DEXA FM[%] - ADP FM[%] lag bei -2.71 [%], bei DEXA FM[%] - BIS FM[%] 4.71 [%]. ALL: BMI vs. DEXA FM[%] r=0.49, WHR vs. DEXA FM[%] r=0.20, KD vs. DEXA FM[%] r=-0.90. Diskussion: Die Körperzusammensetzungsanalyse mittels ADP und BIS liefert sowohl bei HI- Patienten mit HFrEF, als auch bei HFpEF gute bis sehr gute Ergebnisse. Die ADP überschätzte durchschnittlich die FM im Vergleich zur DEXA, bei der BIS hierzu wurde die FM gegenteilig unterschätzt. Um eine noch bessere Validität für ADP und BIS zu erreichen sind HI-spezifische Regressionsgleichungen notwendig. BMI und WHR ermöglichen keine zuverlässige Abschätzung der DEXA FM [%]. Die Körperdichte zeigte eine sehr gute inverse Korrelation gegenüber DEXA FM [%].Introduction: Chronic heart failure (HF) is a fatal disease with severe impact on body composition. Among fluid retention not only cachexia, muscle wasting and lipolysis but also an association to obesity have been described. Early assessments of body composition distribution is an essential instrument for an effective treatment of heart failure and may improve prognosis in these patients. However, data on the comparability of several techniques to measure body composition is limited in the population of heart failure patients. Methods: In this monocentric, non interventional observational study we included 52 symptomatic HF outpatients (NYHA ≥ II), either HF with reduced ejection fraction (HFrEF, n=31) and left ventricular ejection fraction (LVEF) ≤ 40% (Simpson) or HF with preserved ejection fraction (HFpEF, n=19) and end- diastolic left atrial diameter (LAD) ≥ 40mm (parasternal, long axes). To comparison we also examine 20 healthy subjects (REF). Body composition analyses were performed by dual-energy x-ray absorptiometry (DEXA), air dis- placement plethysmography (ADP) and bioelectrical impedance spectroscopy (BIS). For the evaluation we compared five groups HF (HFrEF + HFpEF), HFrEF, HFpEF, REF and ALL (HF+REF). As reference method we used DEXA. Furthermore, we investigated how body-mass-index (BMI), waist-to-hip ratio (WHR) and body density (BD) are correlated with percentage fat mass (FM[%]). To calculate the concordance and correlation of FM[%] we used Lin‘s Concordance Correlation Coefficient (CCC), Pearson Correlation (r) and Bland- Altman-analyses. Results: For ADP vs. DEXA we calculated CCC (r): HF 0.76 (0.87), HFrEF 0.76 (0.89), HFpEF 0.74 (0.80), REF 0.91 (0.92), ALL 0.86 (0.89). And BIS vs. DEXA: HI 0.69 (0.81), HFrEF 0.79 (0.91), HFpEF 0.53 (0.80), REF 0.71 (0.83), ALL 0.74 (0.88). Mean of diffrences between DEXA FM[%] - ADP FM[%] was -2.71 [%] and DEXA FM[%] - BIS FM[%] 4.71%. ALL: BMI vs. DEXA FM[%] r=0.49, WHR vs. DEXA FM[%] r=0.20, BD vs. DEXA FM[%] r=-0.90. Discussion: Body composition analyses resulted reliable concordance and correlation for ADP and BIS in HF and their subgroups HFrEF and HFpEF. ADP overestimated and BIS underestimated FM[%] comparing to DEXA. For higher validity additional HF-specific regression equations are necessary. BMI and WHR are not useful to predict FM[%]. BD shows a high inverted correlation to FM[%]

Treatment of right hepatic artery stump bleeding after pylorus-preserving pancreaticoduodenectomy by covered stent endoprosthesis placement

Serious complications after pancreaticoduodenectomy include rupture of pseudoaneurysms arising from pancreatic fistula and pancreatojejunostomy leakage. We report a case of successful endovascular minimally invasive treatment using a covered stent endoprosthesis of a right hepatic artery stump bleeding following pylorus-preserving pancreaticoduodenectomy that was not suitable for coil or glue embolization due to an insufficiently short neck

Optimizing size thresholds for detection of clinically significant prostate cancer on MRI: Peripheral zone cancers are smaller and more predictable than transition zone tumors

Purpose: To evaluate if size-based cut-offs based on MR imaging can successfully assess clinically significant prostate cancer (csPCA). The goal was to improve the currently applied size-based differentiation criterion in PIRADS. Methods and materials: MRIs of 293 patients who had undergone 3 T MR imaging with subsequent confirmation of prostate cancer on systematic and targeted MRI/TRUS-fusion biopsy were re-read by three radiologists. All identifiable tumors were measured on T2WI for lesions originating in the transition zone (TZ) and on DWI for lesions from the peripheral zone (PZ) and tabulated against their Gleason grade. Results: 309 lesions were analyzed, 213 (68.9 %) in the PZ and 96 (31.1 %) in the TZ. ROC-Analysis showed a stronger correlation between lesion size and clinically significant (defined as Gleason Grade Group= 2) prostate cancer (PCa) for the PZ (AUC= 0.73) compared to the TZ (AUC= 0.63). The calculated Youden index resulted in size cut-offs of 14mm for PZ and 21mm for TZ tumors. Conclusion: Size cut-offs can be used to stratify prostate cancer with different optimal size thresholds in the peripheral zone and transition zone. There was a clearer separation of clinically significant tumors in peripheral zone cancers compared to transition zone cancers. Future iterations of PI-RADS could therefore take different size-based cut-offs for peripheral zone and transition zone cancers into account

American College of Cardiology; American Heart Association Task Force; European Society of Cardiology Committee for Practice Guidelines. ACC/AHA/ESC 2006 guidelines for management of patients with ventricular arrhythmias and the prevention of sudden cardiac death: a report of the American College of Cardiology/American Heart Association Task Force and the European Society of Cardiology Committee for Practice Guidelines (Writing Committee to Develop Guidelines for Management of Patients With Ventricular Arrhythmias and the Prevention of Sudden Cardiac Death).

The purpose this document is to update and combine the previously published recommendations into one source approved by the major cardiology organizations in the United States and Europe. We have consciously attempted to create a streamlined document, not a textbook, that would be useful specifically to locate recommendations on the evaluation and treatment of patients who have or may be at risk for ventricular arrhythmias. Thus, sections on epidemiology, mechanisms and substrates, and clinical presentations are brief, because there are no recommendations for those sections. For the other sections, the wording has been kept to a minimum, and clinical presentations have been confined to those aspects relevant to forming recommendations

Health-status outcomes with invasive or conservative care in coronary disease

BACKGROUND In the ISCHEMIA trial, an invasive strategy with angiographic assessment and revascularization did not reduce clinical events among patients with stable ischemic heart disease and moderate or severe ischemia. A secondary objective of the trial was to assess angina-related health status among these patients. METHODS We assessed angina-related symptoms, function, and quality of life with the Seattle Angina Questionnaire (SAQ) at randomization, at months 1.5, 3, and 6, and every 6 months thereafter in participants who had been randomly assigned to an invasive treatment strategy (2295 participants) or a conservative strategy (2322). Mixed-effects cumulative probability models within a Bayesian framework were used to estimate differences between the treatment groups. The primary outcome of this health-status analysis was the SAQ summary score (scores range from 0 to 100, with higher scores indicating better health status). All analyses were performed in the overall population and according to baseline angina frequency. RESULTS At baseline, 35% of patients reported having no angina in the previous month. SAQ summary scores increased in both treatment groups, with increases at 3, 12, and 36 months that were 4.1 points (95% credible interval, 3.2 to 5.0), 4.2 points (95% credible interval, 3.3 to 5.1), and 2.9 points (95% credible interval, 2.2 to 3.7) higher with the invasive strategy than with the conservative strategy. Differences were larger among participants who had more frequent angina at baseline (8.5 vs. 0.1 points at 3 months and 5.3 vs. 1.2 points at 36 months among participants with daily or weekly angina as compared with no angina). CONCLUSIONS In the overall trial population with moderate or severe ischemia, which included 35% of participants without angina at baseline, patients randomly assigned to the invasive strategy had greater improvement in angina-related health status than those assigned to the conservative strategy. The modest mean differences favoring the invasive strategy in the overall group reflected minimal differences among asymptomatic patients and larger differences among patients who had had angina at baseline

Initial invasive or conservative strategy for stable coronary disease

BACKGROUND Among patients with stable coronary disease and moderate or severe ischemia, whether clinical outcomes are better in those who receive an invasive intervention plus medical therapy than in those who receive medical therapy alone is uncertain. METHODS We randomly assigned 5179 patients with moderate or severe ischemia to an initial invasive strategy (angiography and revascularization when feasible) and medical therapy or to an initial conservative strategy of medical therapy alone and angiography if medical therapy failed. The primary outcome was a composite of death from cardiovascular causes, myocardial infarction, or hospitalization for unstable angina, heart failure, or resuscitated cardiac arrest. A key secondary outcome was death from cardiovascular causes or myocardial infarction. RESULTS Over a median of 3.2 years, 318 primary outcome events occurred in the invasive-strategy group and 352 occurred in the conservative-strategy group. At 6 months, the cumulative event rate was 5.3% in the invasive-strategy group and 3.4% in the conservative-strategy group (difference, 1.9 percentage points; 95% confidence interval [CI], 0.8 to 3.0); at 5 years, the cumulative event rate was 16.4% and 18.2%, respectively (difference, 121.8 percentage points; 95% CI, 124.7 to 1.0). Results were similar with respect to the key secondary outcome. The incidence of the primary outcome was sensitive to the definition of myocardial infarction; a secondary analysis yielded more procedural myocardial infarctions of uncertain clinical importance. There were 145 deaths in the invasive-strategy group and 144 deaths in the conservative-strategy group (hazard ratio, 1.05; 95% CI, 0.83 to 1.32). CONCLUSIONS Among patients with stable coronary disease and moderate or severe ischemia, we did not find evidence that an initial invasive strategy, as compared with an initial conservative strategy, reduced the risk of ischemic cardiovascular events or death from any cause over a median of 3.2 years. The trial findings were sensitive to the definition of myocardial infarction that was used