Post-Reconstitution Hemostatic Stability Profiles of Canadian and German Freeze-Dried Plasma

Despite the importance of the hemostatic properties of reconstituted freeze-dried plasma (FDP) for trauma resuscitation, few studies have been conducted to determine its post-reconstitution hemostatic stability. This study aimed to assess the short- (≤24 h) and long-term (≥168 h) hemostatic stabilities of Canadian and German freeze-dried plasma (CFDP and LyoPlas) after reconstitution and storage under different conditions. Post-reconstitution hemostatic profiles were determined using rotational thromboelastometry (ROTEM) and a Stago analyzer, as both are widely used as standard methods for assessing the quality of plasma. When compared to the initial reconstituted CFDP, there were no changes in ROTEM measurements for INTEM maximum clot firmness (MCF), EXTEM clotting time (CT) and MCF, and Stago measurements for prothrombin time (PT), partial thromboplastin time (PTT), D-dimer concentration, plasminogen, and protein C activities after storage at 4 °C for 24 h and room temperature (RT) (22–25 °C) for 4 h. However, an increase in INTEM CT and decreases in fibrinogen concentration, factors V and VIII, and protein S activities were observed after storage at 4 °C for 24 h, while an increase in factor V and decreases in antithrombin and protein S activities were seen after storage at RT for 4 h. Evaluation of the long-term stability of reconstituted LyoPlas showed decreased stability in both global and specific hemostatic profiles with increasing storage temperatures, particularly at 35 °C, where progressive changes in CT and MCF, PT, PTT, fibrinogen concentration, factor V, antithrombin, protein C, and protein S activities were seen even after storage for 4 h. We confirmed the short-term stability of CFDP in global hemostatic properties after reconstitution and storage at RT, consistent with the shelf life of reconstituted LyoPlas. The long-term stability analyses suggest that the post-reconstitution hemostatic stability of FDP products would decrease over time with increasing storage temperature, with a significant loss of hemostatic functions at 35 °C compared to 22 °C or below. Therefore, the shelf life of reconstituted FDP should be recommended according to the storage temperature

Incomplete reporting of baseline characteristics in clinical trials: an analysis of randomized controlled trials and systematic reviews involving patients with chronic low back pain

OBJECTIVE: The aim of this study was to evaluate the reporting of relevant prognostic information in a sample of randomized controlled trials (RCTs) that investigated treatments for patients with chronic low back pain (LBP). We also analysed how researchers conducting the meta-analyses and systematic reviews addressed the reporting of relevant prognostic information in RCTs. METHODS: We searched the Cochrane Database to identify systematic reviews that investigated non-surgical treatments for patients with chronic LBP. The reported prognostic information was then extracted from the RCTs included in the reviews. We used a purpose-defined score to assess the quantity of information reported in the RCTs. We also determined how the authors of systematic reviews addressed the question of comparability of patient populations between RCTs. RESULTS: Six systematic reviews met our inclusion criteria, and we analysed 84 RCTs. Based on the scores, the reporting of important prognostic variables was incomplete in almost half of the 84 RCTs. Information regarding patients' general health, social support, and work-related conditions was rarely reported. Almost half of the studies included in one of the meta-analyses provided insufficient information that did not allow us to determine whether patients in the primary trials were comparable. CONCLUSIONS: Missing prognostic information potentially threatens the external validity (i.e. the generalizability or applicability) not only of primary studies but also of systematic reviews that investigate treatments for LBP. A detailed description of baseline patient characteristics that includes prognostic information is needed in all RCTs to ensure that clinicians can determine the applicability of the study or review results to their patients

Electrogram fractionation during sinus rhythm occurs in normal voltage atrial tissue in patients with atrial fibrillation

Introduction Electrogram (EGM) fractionation is often associated with diseased atrial tissue; however, mechanisms for fractionation occurring above an established threshold of 0.5 mV have never been characterized. We sought to investigate during sinus rhythm (SR) the mechanisms underlying bipolar EGM fractionation with high-density mapping in patients with atrial fibrillation (AF). Methods Forty-five patients undergoing AF ablation (73% paroxysmal, 27% persistent) were mapped at high density (18562 +/- 2551 points) during SR (Rhythmia). Only bipolar EGMs with voltages above 0.5 mV were considered for analysis. When fractionation (> 40 ms and >4 deflections) was detected, we classified the mechanisms as slow conduction, wave-front collision, or a pivot point. The relationship between EGM duration and amplitude, and tissue anisotropy and slow conduction, was then studied using a computational model. Results Of the 45 left atria analyzed, 133 sites of EGM fragmentation were identified with voltages above 0.5 mV. The most frequent mechanism (64%) was slow conduction (velocity 0.45 m/s +/- 0.2) with mean EGM voltage of 1.1 +/- 0.5 mV and duration of 54.9 +/- 9.4 ms. Wavefront collision was the second most frequent (19%), characterized by higher voltage (1.6 +/- 0.9 mV) and shorter duration (51.3 +/- 11.3 ms). Pivot points (9%) were associated with the highest degree of fractionation with 70.7 +/- 6.6 ms and 1.8 +/- 1 mV. In 10 sites (8%) fractionation was unexplained. The EGM duration was significantly different among the 3 mechanisms (p = .0351). Conclusion In patients with a history of AF, EGM fractionation can occur at amplitudes > 0.5 mV when in SR in areas often considered not to be diseased tissue. The main mechanism of EGM fractionation is slow conduction, followed by wavefront collision and pivot sites

Use of novel electrogram "lumipoint" algorithm to detect critical isthmus and abnormal potentials for ablation in ventricular tachycardia

OBJECTIVES: This study reports the use of a novel "Lumipoint" algorithm in ventricular tachycardia (VT) ablation. BACKGROUND: Automatic mapping systems aid rapid acquisition of activation maps. However, they may annotate farfield rather than nearfield signal in low voltage areas, making maps difficult to interpret. The Lumipoint algorithm analyzes the complete electrogram tracing and therefore includes nearfield signals in its analysis. METHODS: Twenty-two patients with ischemic cardiomyopathy and 5 with dilated cardiomyopathy underwent mapping using the ultra-high density Rhythmia system. Lumipoint algorithms were applied retrospectively. RESULTS: In all left ventricular substrate maps, changing the window of interest to the post-QRS phase automatically identified late potentials. In 25 of 27 left ventricular VT activation maps, a minimum spatial window of interest correctly identified the VT isthmus as seen by the manually annotated map, entrainment, and response to ablation. In 6 maps, the algorithm identified the isthmus where the standard automatically annotated map did not. CONCLUSIONS: The Lumipoint algorithm automatically highlights areas with electrograms having specific characteristics or timings. This can identify late and fractionated potentials and regions that exhibit discontinuous activation, as well as the isthmus of a VT circuit. These features may enhance human interpretation of the electrogram signals during a case, particularly where the circuit lies in partial scar with low amplitude nearfield signals and potentially allow a more targeted ablation strategy

Characteristics of scar-related ventricular tachycardia circuits using ultra-high-density mapping

BACKGROUND: Ventricular tachycardia (VT) with structural heart disease is dependent on reentry within scar regions. We set out to assess the VT circuit in greater detail than has hitherto been possible, using ultra-high-density mapping. METHODS: All ultra-high-density mapping guided VT ablation cases from 6 high-volume European centers were assessed. Maps were analyzed offline to generate activation maps of tachycardia circuits. Topography, conduction velocity, and voltage of the VT circuit were analyzed in complete maps. RESULTS: Thirty-six tachycardias in 31 patients were identified, 29 male and 27 ischemic. VT circuits and isthmuses were complex, 11 were single loop and 25 double loop; 3 had 2 entrances, 5 had 2 exits, and 15 had dead ends of activation. Isthmuses were defined by barriers, which included anatomic obstacles, lines of complete block, and slow conduction (in 27/36 isthmuses). Median conduction velocity was 0.08 m/s in entrance zones, 0.29 m/s in isthmus regions ( P<0.001), and 0.11 m/s in exit regions ( P=0.002). Median local voltage in the isthmus was 0.12 mV during tachycardia and 0.06 mV in paced/sinus rhythm. Two circuits were identifiable in 5 patients. The median timing of activation was 16% of diastole in entrances, 47% in the mid isthmus, and 77% in exits. CONCLUSIONS: VT circuits identified were complex, some of them having multiple entrances, exits, and dead ends. The barriers to conduction in the isthmus seem to be partly functional in 75% of circuits. Conduction velocity in the VT isthmus slowed at isthmus entrances and exits when compared with the mid isthmus. Isthmus voltage is often higher in VT than in sinus or paced rhythms