bluuebunny/crossref_metadata_2025_split huggingface dataset:
Thromboembolic Events in Patients on Extracorporeal Membrane Oxygenation without Anticoagulation
Authors: Lamarche Yoan , Chow Bryan , Bédard Annie , Johal Navreet , Kaan Annemarie , Humphries Karin H. , Cheung Anson 
Published: January 2019

Objective Heparinization is thought to be mandatory to avoid thromboembolic complications during venoarterial extracorporeal membrane oxygenation (VA-ECMO). However, bleeding complications are common. We report our experience of VA-ECMO without systemic anticoagulation. Methods A prospectively assembled database describing all ECMO cases from 2000 to 2008 was analyzed. A heparin coated circuit (Medtronic, Inc., Minneapolis, MN USA) and membrane oxygenator (Quadrox D Bioline oxygenator; MAQUET, Rastatt, Germany) were used in all cases. After the initiation of VA-ECMO support, all coagulation parameters were corrected. No further systemic maintenance anticoagulant was given, except at the time of weaning. Results Thirty-two patients received VA-ECMO support; 20 patients (62.5%) were males with a median age of 52.5 years (interquartile range, 40.4–61.1 years). Central and peripheral cannulations were 53% and 47%, respectively. Etiologies of cardiogenic shock were postcardiotomy (75%, n = 24) and as a support to cardiopulmonary resuscitation in 25% of cases (n = 8). Thirty-day mortality was 43.8%. Median duration of ECMO support was 46.3 hours (interquartile range, 26.8–87.8 hours). The median number of packed red blood cell transfusions was 18 ± 25. Complications include five patients (16%) with limb ischemia requiring intervention, 15 patients (46.9%) had acute renal failure, two patients had deep vein thrombosis, and two patients had intracardiac clots detected on echocardiograms. No patient had a cerebrovascular event. Incidence of membrane oxygenator failure was low, requiring replacement in three patients; no adverse event occurred during replacement. Fourteen patients (43.8%) were re-explored for bleeding. Fourteen patients (44%) were discharged home and were long-term survivors. Conclusions VA-ECMO support without systemic anticoagulation may reduce bleeding complications and transfusion requirement, without increasing the risk of thromboembolism.
Augmented Reality Image Guidance during Off-Pump Mitral Valve Replacement through the Guiraudon Universal Cardiac Introducer
Authors: Guiraudon Gerard M. , Jones Douglas L. , Bainbridge Daniel , Linte Cristian , Pace Danielle , Moore John , Wedlake Christopher , Lang Pencilla , Peters Terry M. 
Published: January 2019

Objective We report our experience with ultrasound augmented reality (US-AR) guidance for mitral valve prosthesis (MVP) implantation in the pig using off-pump, closed, beating intracardiac access through the Guiraudon Universal Cardiac Introducer attached to the left atrial appendage. Methods Before testing US-AR guidance, a feasibility pilot study on nine pigs was performed using US alone. US-AR guidance, tested on a heart phantom, was subsequently used in three pigs (~65 kg) using a tracked transesophageal echocardiography probe, augmented with registration of a 3D computed tomography scan, and virtual representation of the MVP and clip-delivering tool (Clipper); three pigs were used to test feature-based registration. Results Navigation of the MVP was facilitated by the 3D anatomic display. AR displayed the MVP and the Clipper within the Atamai Viewer, with excellent accuracy for tool placement. Positioning the Clipper was hampered by the design of the MVP holder and Clipper. These limitations were well displayed by AR, which provided guidance for improved design of tools. Conclusions US-AR provided informative image guidance. It documented the flaws of the current implantation technology. This information could not be obtained by any other method of evaluation. These evaluations provided guidance for designing an integrated tool: combining an unobtrusive valve holder that allows the MVP to function properly as soon as positioned, and an anchoring system, with clips that can be released one at a time, and retracted if necessary, for optimal results. The portability of Real-time US-AR may prove to be the ideal practical image guidance system for all closed intracardiac interventions.
Activation of Coagulation and Fibrinolysis after Off-Pump Coronary Artery Bypass Grafting with or without Endotracheal General Anesthesia
Authors: Yachi Tsuyoshi , Watanabe Go , Tomita Shigeyuki 
Published: January 2019

Objective In this study, we measured the activity of coagulation and fibrinolysis and clarified the presence of certain differences between off-pump coronary artery bypass grafting (OPCAB) cases and awake off-pump coronary artery bypass grafting (AOCAB) cases to evaluate whether AOCAB is actually safe from the viewpoint of coagulability. Methods 8 underwent OPCAB and 6 underwent AOCAB. The following factors inducing coagulation and fibrinolysis were measured for upto 5 days after the operation: platelet counts, prothrombin time, activated partial thromboplastin time, fibrinogen, fibrin degeneration products, D-dimer, thrombin-antithrombin III complex (TAT), α2-plasmin inhibitor-plasmin complex, prothrombin fragment 1, 2 (F1+2), thrombomodulin, β-thromboglobulin (β-TG), and platelet factor-4. Results At 5 days after the operation, fibrin degeneration products, D-dimer, α2–plasmin inhibitor-plasmin complex, and F1 + 2 levels of the OPCAB group were significantly higher compared with their baseline values and those of the AOCAB group. At 5 days after the operation, thrombin-antithrombin III complex levels of the OPCAB group were significantly higher than those of the AOCAB group. Fibrinogen levels of the OPCAB group were significantly higher than their baseline values at 3 days after the operation (POD3) and 5 days after the operation (POD5). Conclusions In this study, the hypercoagulable state at POD5 was suggested in the patients in the OPCAB group, but not in those in the AOCAB group. Further study is necessary to confirm these results, and future studies would evaluate the potential benefit of AOCAB procedure from the viewpoint of perioperative coagulability.
Acute Kidney Injury after Transcatheter Aortic Valve Implantation: Incidence, Risk Factors, and Prognostic Effects
Authors: Alassar Aiman , Roy David , Abdulkareem Nada , Valencia Oswaldo , Brecker Stephen , Jahangiri Marjan 
Published: January 2019

Objective Acute kidney injury (AKI) is a common complication after surgical aortic valve replacement and is associated with increased mortality. Transcatheter aortic valve implantation (TAVI) is now considered the criterion standard treatment of patients with severe symptomatic aortic stenosis ineligible for surgery. The aim of this study was to establish the incidence, risk factors, and prognostic consequences of AKI after TAVI and at 1-year follow-up in a single center. Methods Between December 2007 and March 2011, a total of 79 patients with severe aortic stenosis who underwent 81 TAVI procedures with the Medtronic CoreValve System or the Edwards SAPIEN heart valve were included. Baseline characteristics and procedural complications were recorded. Acute kidney injury was defined according to the Valve Academic Research Consortium criteria (modified risk, injury, failure, loss, and end-stage kidney disease criteria). Results The mean age was 84 (78–87) years; 49 were men. After TAVI, 10 patients (12.3%) developed AKI, which had completely resolved in 9 patients before hospital discharge. Nine patients (10%) had mild AKI (stage 1) and only one patient (10%) experienced moderate AKI (stage 2) according to Valve Academic Research Consortium definitions. The predictive factors of AKI were diabetes (odds ratio, 6.722; P = 0.004) and preoperative creatinine level greater than 104 μmol/L (odds ratio, 1.024; P = 0.02). Thirteen patients (16.4%) died within 1 year after TAVI. Three of the nonsurvivors (3.7%) developed AKI postoperatively. Acute kidney injury was, however, not a predictive factor of 1-year mortality after TAVI. Conclusions Acute kidney injury occurred in 12.3% of the patients after TAVI and persisted in only one patient before hospital discharge. Diabetes and preoperative creatinine level were found to be the main predictive factors of AKI after TAVI. Acute kidney injury was not associated with increased 1-year mortality.
Evaluation of a Novel Cryoablation System: In vitro Testing of Heat Capacity and Freezing Temperatures
Authors: Weimar Timo , Lee Anson M. , Ray Shuddhadeb , Schuessler Richard B. , Damiano Ralph J. 
Published: January 2019

Objective Cryoablation has been used to ablate cardiac tissue for decades and has been shown to be able to replace incisions in the surgical treatment of atrial fibrillation. This in vitro study evaluates the performance of a novel cryoprobe and compares it with existing commercially available devices. Methods A new malleable 10-cm aluminum cryoprobe was compared with a rigid 3.5-cm copper linear probe using in vitro testing to evaluate performances under different thermal loads and with different tissue thicknesses. Radial dimensions of ice formation were measured in each water bath by a high-precision laser 2 minutes after the onset of cooling. Probe-surface temperatures were recorded by thermocouples. Tissue temperature was measured at depths of 4 mm and 5 mm from the probe-tissue interface. Time to reach a tissue temperature of −20°C was recorded. Results Ice formation increased significantly with lower water-bath temperatures (P < 0.001). Width and depth of ice formation were significantly less for the rigid linear probe (P < 0.012 and P < 0.001, respectively). There was no difference between the probes in the maximal negative temperature reached under different thermal loads or at different tissue depths. The malleable probe achieved significantly lower temperatures at the proximal compared with the distal end (–61.7°C vs −55.0°C, respectively; P < 0.001). A tissue temperature of −20°C was reached earlier at 4 mm than at 5 mm (P < 0.001) and was achieved significantly faster with the 3011 Maze Linear probe (P < 0.021). Conclusions The new malleable probe achieved rapid freezing to clinically relevant levels in up to 5-mm–thick tissue. Both probes maintained their performance under a wide range of thermal loads.
Intraoperative Fluorescence Imaging after Transit-Time Flow Measurement during Coronary Artery Bypass Grafting
Authors: Kuroyanagi Satoshi , Asai Tohru , Suzuki Tomoaki 
Published: January 2019

Objective This report describes the complementary use of transit-time flow measurement (TTFM) and intraoperative fluorescence imaging (IFI) during off-pump coronary artery bypass grafting (OPCAB) and compares their results with those of subsequent coronary angiography. Methods The subjects were 159 OPCAB patients, with a total of 435 grafts at a single center between April 2009 and November 2011. During surgery, all grafts were assessed initially by both TTFM and IFI. Transit-time flow measurement was used for screening grafts for possible revision, then IFI was applied to check patency. For IFI, indocyanine green was injected into the superior vena cava, then the presence and timing of fluorescent enhancement were monitored in coronary and graft vessels. Results Twelve grafts were revised after poor TTFM scores. Despite some poor TTFM scores even after revision, subsequent IFI showed that all grafts were enhanced. However, two grafts showed delayed enhancement. In one internal thoracic artery (ITA), delay was caused by competitive flow from a mildly stenotic native coronary artery. The other delayed-enhancement ITA was revised. Reanastomosis was constructed with shorter ITA at the larger lumen size. After about 1 week, all patients underwent coronary angiography (plain angiography for 31, computed tomography angiography for 128). These demonstrated that all 385 arterial grafts, and 48 out of 50 venous grafts, were patent. Conclusions Our OPCAB series using TTFM and IFI achieve extremely high graft patency in the early graft assessments. “Delayed enhancement” of one ITA in comparison with the other suggested either native competitive flow or a bypass graft problem.
Role of Preoperative Femoral Artery Color Doppler Echocardiography in Minimally Invasive Cardiac Surgery
Authors: Ceresa Fabrizio , Sansone Fabrizio , Patanè Francesco 
Published: January 2019

Objective Minimally invasive cardiac surgery (MICS) through a right thoracotomy has been developed in the past decades, leading to a significant improvement of postoperative outcome. The risk for complications during peripheral cannulation should be considered. We report our experience of preoperative evaluation by color Doppler echocardiography for patients scheduled for MICS. Methods Between January 2009 and December 2011, a total of 155 patients were operated on for mitral valve disease or patent foramen ovale. One hundred thirteen patients were approached by MICS through the fourth intercostal space, and arterial cannulation was peripheral (femoral artery). One hundred nineteen patients scheduled for MICS were screened by ultrasound evaluation before the induction of anesthesia, by means of a vascular linear probe. Three parameters were considered: longitudinal axis, transverse axis, and atherosclerotic disease (AD). Results Peripheral arterial cannulation of vessels greater than 7 mm is safe because we experienced no complications in 69 patients. In case of diameters 6.5 to 7 mm, peripheral cannulation should be avoided in case of presence of calcifications; in fact, three patients in our series with AD had vascular injuries; 25 patients without femoral artery AD had no complications. Cannulation was avoided in six patients with widespread AD. In case of diameters less than 6.5 mm, peripheral cannulation was avoided. Conclusions Peripheral cannulation is safe when a careful preoperative evaluation is performed. The diameters of the femoral vessels are predictors of complications in case of absence of other contraindications.
Novel Mitral Repair Device for the Treatment of Severe Mitral Regurgitation: Preclinical Ovine Acute and Chronic Implantation Model
Authors: Hill Arthur C. , Lesh Michael D. , Khairkhahan Alexander 
Published: January 2019

Objective A project is now underway to implement a novel percutaneous mitral repair system for severe mitral regurgitation (MR). The initial phase of the project consists of proof-of-concept by testing device characteristics using open surgical implantation. When surgical proof-of-concept of the intended percutaneous design is completed, a second phase of the project will consist of in vivo testing of the percutaneous transseptal system. The device is currently being designed to fold into a 17F catheter system and to unfold within the left atrium where attachment is accomplished using a reversible anchoring system. The purpose of this study was to show functionality of the device in elimination of MR using the open surgical method. Methods We have performed surgical prototype device implantation in 5 acute and 7 chronic sheep preparations. We created a P2-flail model of severe (4+) MR in the 12 sheep. Via a minimally invasive left thoracotomy incision and open repair on cardiopulmonary bypass, the device was implanted to determine efficacy of elimination of severe MR. Implantation was considered successful if 4+ regurgitation was converted to 1+ MR or lower. Left ventriculography and epicardial 2-dimensional/3-dimensional echocardiography were used to assess repair; serial 2-dimensional/3-dimensional transthoracic echocardiography was used to assess long-term mitral repair status. Results Twelve sheep had surgical creation of severe (4+) MR by cutting all chordae to the P2 scallop of the mitral valve; this preparation was tested and was found to produce 100% acute fatality without repair of the mitral valve. Five sheep had acute implantation of the device with elimination of regurgitation in 5/5 sheep. Seven sheep had chronic (1–7 month) implantation of the device. The device was tested in the chronic model for clinical status, residual regurgitation, thrombosis, and histopathology. All sheep had mitigation of MR and survived to the intended date of death. Conclusions Proof-of-concept of a novel percutaneous mitral repair device has been completed using an ovine P2-flail severe MR model. The device has characteristics that will allow its use in posterior leaflet degenerative disease and functional/secondary MR. Open, minimally invasive, and robotic surgical implantation of the device can also be developed as an alternative to the percutaneous approach.
Robotic Application of a Novel Dual-Energy Device for Left Atrial Ablation: Intraoperative and Early Postoperative Results
Authors: Balkhy Husam H. , Vloka Margot E. , Chapman Peter D. , Peters Christopher C. 
Published: January 2019

Objective Recent trials show that in patients with atrial fibrillation (AF), pulmonary vein isolation performed with bipolar surgical ablation clamps using small bilateral thoracotomies is more effective than pulmonary vein isolation using standard catheter ablation. This improved efficacy comes with higher invasiveness including difficulty in execution and potentially more acute complications. Monopolar “loop” devices overcome these drawbacks but at the potential cost of decreased efficacy. Technology that has bipolar effectiveness but with improved access and safety profiles, capable of being deployed endoscopically on a beating heart, would be desirable. We evaluated an ablation system that may have all of these characteristics. Methods Between May 2012 and May 2013, 30 patients were treated surgically for AF using a right-sided endoscopic approach with robotic assistance. In each patient, a “box” ablation lesion set was created around all pulmonary veins with a new linear suction-applied dual-mode (monopolar and bipolar) radiofrequency (RF) ablation device that was looped around the pulmonary veins. Temperature-controlled RF was applied for 60 seconds, with a set temperature of 70°C, first in the bipolar mode and then in a separate RF ablation for 60 seconds at 70°C in the monopolar mode. Acute effectiveness of the procedure was assessed using conduction block testing and by attempting to induce sustained AF with rapid atrial pacing. The left atrial appendage (LAA) was occluded in all patients with multiple ENDOLOOP snares using a left video-assisted thoracoscopic surgery approach under transesophageal echocardiography guidance, after which the tip of the LAA was incised to empty the LAA of blood. All patients were seen clinically at 30, 90, and 180 days with routine electrocardiography monitoring: at 6 months, 24-hour Holter monitoring was performed. Results Acute conduction block was achieved in 93% the of patients, and sustained AF could not be induced by rapid atrial pacing after the surgical ablation procedure in 90% of the patients. At 3- and 6-month follow-up, 88% and 81% of the patients, respectively, were in sinus rhythm. Of 16 the patients seen at 12-month follow-up, 14 (88%) were in sinus rhythm with 44% still on antiarrhythmic medications. Conclusions The newly introduced bipolar/monopolar RF ablation device can be easily positioned using a right endoscopic approach. Robotic assistance enables effective fat removal for accurate and easy placement of the device around the pulmonary veins. With the use of this approach, the device is safe and effective in electrically isolating the pulmonary veins.
The FLUENT study design: investigating immune cell subset and neurofilament changes in patients with relapsing multiple sclerosis treated with fingolimod
Authors: Cohen Jeffrey A , Bar-Or Amit , Cree Bruce A C , Mao-Draayer Yang , Han May H , Singer Barry , Jannu Ann , Kolodny Scott , Meng Xiangyi , Winger Ryan C 
Published: January 2019

Background Fingolimod is a sphingosine 1-phosphate receptor modulator for the treatment of patients with relapsing forms of multiple sclerosis (RMS). Fingolimod sequesters lymphocytes within lymphoid tissue thereby reducing the counts of circulating lymphocytes. However, fingolimod’s effects on the innate and adaptive components of the immune system are incompletely understood. Objective The FLUENT study will investigate temporal changes in circulating immune cell subsets in patients with RMS treated with fingolimod. Secondary objectives include examining the association between anti-John Cunningham virus (JCV) antibody status/index and phenotypic changes in innate and T and B cell subsets in patients on fingolimod therapy, and the association between serum neurofilament levels and clinical outcomes. Methods FLUENT is a prospective, multicenter, two-cohort, nonrandomized, open-label Phase IV study. Cohort 1 will include fingolimod-naïve patients and Cohort 2 will include patients who have received fingolimod 0.5 mg/day continuously for ≥2 years. Changes in the cellular components of the innate and adaptive immune system will be characterized over 12 months. Results The study is ongoing. Conclusion FLUENT may provide evidence for the use of immunologic profiling in predicting efficacy and risk of infection in patients with RMS treated with fingolimod.
Influence of Self-reported Fatigue and Sex on Baseline Concussion Assessment Scores
Authors: Combs Patricia R. , Ford Cassie B. , Campbell Kody R. , Carneiro Kevin A. , Mihalik Jason P. 
Published: January 2019

Background: Baseline concussion assessments are advocated to provide an objective preinjury point of comparison for determining the extent of postconcussion neurological deficits and to assist with return-to-activity decision making. Many factors, including testing environment, proctor availability, and testing group size, can influence test accuracy and validity; however, it is unknown how self-reported fatigue affects test scores. Purpose: To investigate the influence of self-reported fatigue and patient sex on baseline concussion assessment scores. Study Design: Cross-sectional study; Level of evidence, 3. Methods: Participants included 494 healthy Division I college student-athletes (221 women, 273 men; mean ± SD age, 20.0 ± 1.3 years). During preseason baseline testing, participants were asked to rate their fatigue on a scale from 0 to 100 based on how they normally feel and function each day (0, completely exhausted; 100, completely awake and alert). Each participant then completed a multimodal baseline concussion assessment, including a graded symptom checklist (number of symptoms endorsed and total symptom severity score), Standardized Assessment of Concussion (SAC), Balance Error Scoring System (BESS), and CNS Vital Signs computerized neurocognitive testing. Multiple linear regressions tested whether self-reported fatigue and sex predicted baseline concussion examination scores. Results: Athletes with higher self-reported fatigue levels (ß = –0.014, P < .01) and female athletes (ß = –0.216, P < .01) reported more total symptoms. Being male (ß = 0.856, P < .01) increased the likelihood of endorsing zero symptoms versus any symptoms by a factor of 2.40. Women also had significantly higher SAC scores (ß = 0.569, P < .001), BESS scores (ß = –2.747, P < .001), and CNS Vital Signs summary scores (ß = 4.506, P < .001). SAC, BESS, and CNS Vital Signs scores were not predicted by fatigue level ( P > .05). Conclusion: Female athletes and fatigued athletes endorsed more symptoms and higher symptom severity at baseline. Using total symptom endorsement and total symptom severity scores as part of the postinjury management is a common practice. The current data suggest that levels of reported exhaustion can influence concussion assessment scores meant to represent a healthy baseline and likely would interfere with postinjury assessment scores.