Cardiac CT Angiography (CCTA) predicts left atrial appendage occluder device size and procedure outcome

Aim

To investigate the role of cardiac CT angiography (CCTA) in predicting optimal left atrial appendage (LAA) occluder size and procedure outcome.

Methods and results

Thirty-six patients underwent pre-procedural CCTA. CCTA and TEE LAA orifice diameters and perimeters were compared with the implanted device size. CCTA 3D configuration was correlated with procedure outcome. Watchman? device (N?=?18): diameters were 21?±?4, 26?±?5 and 25?±?3 mm for TEE, CCTA and inserted device, respectively. Average perimeters were 61?±?10, 74?±?8 and 78?±?11 mm for TEE, CCTA and inserted device, respectively. Better agreement with the device size was found for CCTA compared to TEE (Bland–Altman). ACP? device (N?=?15): diameters were 20?±?5, 25?±?4 and 23?±?4 for TEE, CCTA and inserted device, respectively. Average perimeters were 58?±?11, 72?±?15 and 72?±?13 mm for TEE, CCTA and inserted device, respectively. Excellent correlation and agreement with the device size was found for CCTA compared to TEE. CCTA perimeter >100 mm and “cactus” 3D configuration had a specificity of 96 and 81% respectively for procedure failure.

Conclusions

CCTA LAA ostial perimeter predicted better the optimal occluder size as compared with the currently used LAA TEE diameter. Moreover, CCTA 3D data may help in predicting potential complications.

     

Development of digital phantoms based on a finite element model to simulate low-attenuation areas in CT imaging for pulmonary emphysema quantification

Purpose

To develop an innovative finite element (FE) model of lung parenchyma which simulates pulmonary emphysema on CT imaging. The model is aimed to generate a set of digital phantoms of low-attenuation areas (LAA) images with different grades of emphysema severity.

Methods

Four individual parameter configurations simulating different grades of emphysema severity were utilized to generate 40 FE models using ten randomizations for each setting. We compared two measures of emphysema severity (relative area (RA) and the exponent D of the cumulative distribution function of LAA clusters size) between the simulated LAA images and those computed directly on the models output (considered as reference).

Results

The LAA images obtained from our model output can simulate CT-LAA images in subjects with different grades of emphysema severity. Both RA and D computed on simulated LAA images were underestimated as compared to those calculated on the models output, suggesting that measurements in CT imaging may not be accurate in the assessment of real emphysema extent.

Conclusions

Our model is able to mimic the cluster size distribution of LAA on CT imaging of subjects with pulmonary emphysema. The model could be useful to generate standard test images and to design physical phantoms of LAA images for the assessment of the accuracy of indexes for the radiologic quantitation of emphysema.

     

Poor outcomes associated with antithrombotic undertreatment in patients with atrial fibrillation attending Gondar University Hospital: a retrospective cohort study

Background

Atrial fibrillation (AF) is a major risk factor for stroke as it increases the incidence of stroke nearly fivefold. Antithrombotic treatment is recommended for the prevention of stroke in AF patients. However, majorly due to fear of risk of bleeding, adherence to recommendations is not observed. The aim of this study was to investigate the impact of antithrombotic undertreatment, on ischemic stroke and/or all-cause mortality in patients with AF.

Methods

A retrospective cohort study was conducted from January 7, 2017 to April 30 2017 using medical records of patients with AF attending Gondar University Hospital (GUH) between November 2012 and September 2016. Patients receiving appropriate antithrombotic management and those on undertreatment, were followed for development of ischemic stroke and/or all-cause mortality. Kaplan-Meier and a log-rank test was used to plot the survival analysis curve. Cox regression was used to determine the predictors of guideline-adherent antithrombotic therapy.

Results

The final analysis included 159 AF patients with a median age of 60 years. Of these, nearly two third (64.78%) of patients were receiving undertreatment for antithrombotic medications. Upon multivariate analysis, history of ischemic stroke/transient ischemic attack (TIA) was associated with lower incidence of antithrombotic undertreatment. A significant increase (HR: 8.194, 95% CI: 2.911–23.066)] in the incidence of ischemic stroke and/or all-cause mortality was observed in patients with undertreatment. Up-on multivariate analysis, only increased age was associated with a statistically significant increase incidence of ischemic stroke and/or all-cause mortality, while only history of ischemic stroke/TIA was associated with a decrease in the risk of ischemic stroke and/or all-cause mortality.

Conclusion

Adherence to antithrombotic guideline recommendations was found to be crucial in reducing the incidence of ischemic stroke and/or all-cause mortality in patients with AF without increasing the risk of bleeding. However, undertreatment to antithrombotic medications was found to be high (64.78%) and was associated with poorer outcomes in terms of ischemic stroke and/or all-cause mortality. Impact on practice: This research highlighted the magnitude of antithrombotic undertreatment and its impact on ischemic stroke and/or all-cause mortality in patients with AF. This article has to alert prescribers to routinely evaluate AF patients’ risk for ischemic stroke and provide appropriate interventions based on guideline recommendations.

     

Advances in Clinical Cardiology 2016: A Summary of the Key Clinical Trials

Introduction

The findings of many new cardiology clinical trials over the last year have been published or presented at major international meetings. This paper aims to describe and place in context a summary of the key clinical trials in cardiology presented between January and December 2016.

Methods

The authors reviewed clinical trials presented at major cardiology conferences during 2016 including the American College of Cardiology (ACC), European Association for Percutaneous Cardiovascular Interventions (EuroPCR), European Society of Cardiology (ESC), European Association for the Study of Diabetes (EASD), Transcatheter Cardiovascular Therapeutics (TCT), and the American Heart Association (AHA). Selection criteria were trials with a broad relevance to the cardiology community and those with potential to change current practice.

Results

A total of 57 key cardiology clinical trials were identified for inclusion. Here we describe and place in clinical context the key findings of new data relating to interventional and structural cardiology including delayed stenting following primary angioplasty, contrast-induced nephropathy, management of jailed wires, optimal duration of dual antiplatelet therapy (DAPT), stenting vs bypass for left main disease, new generation stents (BioFreedom, Orsiro, Absorb), transcatheter aortic valve implantation (Edwards Sapien XT, transcatheter embolic protection), and closure devices (Watchman, Amplatzer). New preventative cardiology data include trials of bariatric surgery, empagliflozin, liraglutide, semaglutide, PCSK9 inhibitors (evolocumab and alirocumab), and inclisiran. Antiplatelet therapy trials include platelet function monitoring and ticagrelor vs clopidogrel for peripheral vascular disease. New data are also presented in fields of heart failure (sacubitril/valsartan, aliskiren, spironolactone), atrial fibrillation (rivaroxaban in patients undergoing coronary intervention, edoxaban in DC cardioversion), cardiac devices (implantable cardioverter defibrillator in non-ischemic cardiomyopathy), and electrophysiology (cryoballoon vs radiofrequency ablation).

Conclusion

This paper presents a summary of key clinical cardiology trials during the past year and should be of practical value to both clinicians and cardiology researchers.

     

The Patterns of Non-vitamin K Antagonist Oral Anticoagulants (NOACs) Use in Patients with Atrial Fibrillation in Seven Balkan Countries: a Report from the BALKAN-AF Survey

Introduction

Data on management of atrial fibrillation (AF) in the Balkan Region are scarce. To capture the patterns in AF management in contemporary clinical practice in the Balkan countries a prospective survey was conducted between December 2014 and February 2015, and we report results pertinent to the use of non-vitamin K antagonist oral anticoagulants (NOACs).

Methods

A 14-week prospective, multicenter survey of consecutive AF patients seen by cardiologists or internal medicine specialists was conducted in Albania, Bosnia and Herzegovina, Bulgaria, Croatia, Montenegro, Romania, and Serbia (a total of about 50 million inhabitants).

Results

Of 2712 enrolled patients, 2663 (98.2%) had complete data relevant to oral anticoagulant (OAC) use (mean age 69.1 ± 10.9 years, female 44.6%). Overall, OAC was used in 1960 patients (73.6%) of whom 338 (17.2%) received NOACs. Malignancy [odds ratio (OR), 95% confidence interval (CI) 2.06, 1.20–3.56], rhythm control (OR 1.64, 1.25–2.16), and treatment by cardiologists were independent predictors of NOAC use (OR 2.32, 1.51–3.54) [all p < 0.01)], whilst heart failure and valvular disease were negatively associated with NOAC use (both p < 0.01). Individual stroke and bleeding risk were not significantly associated with NOAC use on multivariate analysis.

Conclusions

NOACs are increasingly used in AF patients in the Balkan Region, but NOAC use is predominantly guided by factors other than evidence-based decision-making (e.g., drug availability on the market or reimbursement policy). Efforts are needed to establish an evidence-based approach to OAC selection and to facilitate the optimal use of OAC, thus improving the outcomes in AF patients in this large region.

     

Diagnosis and management of skin and soft tissue infections in the intensive care unit: a review

Purpose

To review the salient features of the diagnosis and management of the most common skin and soft tissue infections (SSTI). This review focuses on severe SSTIs that require care in an intensive care unit (ICU), including toxic shock syndrome, myonecrosis/gas gangrene, and necrotizing fasciitis.

Methods

Guidelines, expert opinion, and local institutional policies were reviewed.

Results

Severe SSTIs are common and their management complex due to regional variation in predominant pathogens and antimicrobial resistance patterns, as well as variations in host immune responses. Unique aspects of care for SSTIs in the ICU are discussed, including the role of prosthetic devices, risk factors for bacteremia, and the need for surgical consultation. SSTI mimetics, the role of dermatologic consultation, and the unique features of SSTIs in immunocompromised hosts are also described.

Conclusions

We provide recommendations for clinicians regarding optimal SSTI management in the ICU setting.

     

Toxicity and Pharmacokinetics of Sustained-Release Dexamethasone in Beagle Dogs

Introduction

The purpose of the present study was to examine the potential ocular and systemic toxicity and toxicokinetics/pharmacokinetics of sustained-release dexamethasone in canines.

Methods

In this non-randomized study, intracanalicular depots (dexamethasone-loaded or placebo vehicle) were inserted into both eyes of 33 beagles. Tear fluid and plasma were collected for toxicokinetic/pharmacokinetic analysis of dexamethasone, ophthalmic examinations were performed for signs of toxicity, and urine and blood samples were collected for urinalysis, hematology, clinical chemistry, and coagulation analysis. Animals were observed daily for signs of toxicity. Macroscopic and microscopic evaluations were performed.

Results

Mean dexamethasone tear fluid concentration from the dexamethasone group decreased from 4245 ng/mL 6-h post-insertion to 1044 ng/mL on Day 35. All plasma dexamethasone levels were below the limit of quantitation. No systemic or ocular toxicities were attributed to the dexamethasone depot.

Conclusion

Sustained-release dexamethasone produced no identifiable ocular or systemic toxicity in this animal model, and pharmacokinetics demonstrated a tapered, sustained drug release.

Funding

Ocular Therapeutix.

     

Effect of sinus rhythm restoration on markers of thrombin generation in atrial fibrillation

Background

Atrial fibrillation (AF) confers a hypercoagulable state; however, it is not clear whether restoration of sinus rhythm is associated with normalisation of markers of thrombogenesis. We studied the impact of sustained sinus rhythm on prothrombotic markers, and their predictive abilities in foreseeing rhythm outcome after cardioversion.

Methods

In a double blind, placebo-controlled study, 171 patients referred for electrical cardioversion of persistent AF were randomised to receive candesartan or placebo for 3-6 weeks before and 6 months after cardioversion. Endogenous thrombin potential (ETP), prothrombin fragment 1?+?2 (F1?+?2) and D-dimer were measured before cardioversion and at end of study. These markers were also measured in a reference group comprising 49 subjects without AF.

Results

The markers remained unchanged in those 28 patients who maintained sinus rhythm. Discontinuation of warfarin treatment in a subset of 13 low-risk patients in sinus rhythm was associated with significantly higher levels of D-dimer and F1?+?2 compared to the reference group; D-dimer (456 ng/mL (276, 763) vs. 279 ng/mL (192, 348), p?=?0.002) and F1?+?2 (700 pmol/L (345, 845) vs. 232 pmol/L (190, 281), p?<?0.001). None of the markers were associated with rhythm outcome after electrical cardioversion.

Conclusions

Sustained sinus rhythm for 6 months after cardioversion for AF had no impact on ETP, F1?+?2 or D-dimer levels. Discontinuation of warfarin in low-risk patients with sustained sinus rhythm was associated with significantly higher levels of D-dimer and F1?+?2 compared to the reference group. Our results suggest persistent hypercoagulability in AF patients despite long-term maintenance of sinus rhythm.

Trial registration

The CAPRAF study was registered at clinicaltrials.gov (NCT00130975) in August 2005.

     

Detection of Brain Tumors and Systemic Metastases Using NanoLuc and Fluc for Dual Reporter Imaging

Purpose

Bioluminescence imaging (BLI) is a technique with a low background noise and high sensitivity which is widely used in mice models in oncology. We aimed to assess BLI efficiency of the new luciferase NanoLuc (Nluc) for glioblastoma cell lines and tumors, including for dual reporter applications of deep brain tumors and systemic metastasis when combined with firefly luciferase (Fluc).

Procedures

U87 cells were genetically modified for constitutive production of either Nluc, Fluc, or both and assayed for luciferase activity and BLI on cell lysates, living cells, subcutaneous tumors, brain tumors, and systemic metastases.

Results

In vitro, light production by Nluc activity is higher than Fluc. In vivo, Nluc allows for tumor detection including for deep brain tumors and systemic metastases.

Conclusions

Nluc appears to be a useful tool to combine with Fluc for dual imaging in vivo using bioluminescence, allowing for the detection of distinct events in deep tissues within the same organism.

     

Interspinous implants: are the new implants better than the last generation? A review

Purpose of review

Interspinous process devices (IPDs) are used in the surgical treatment of lumbar spinal stenosis. The purpose of this review is to compare the first generation with the next-generation devices in terms of complications, device failure, reoperation rates, symptom relief, and outcome.

Recent findings

Thirty-seven studies were included from 2011 to 2016. Device failure occurred at a mean of 3.7%, with a lower tendency to happen with next-generation IPDs. Reoperations occurred at a lower rate with the next-generation devices, with a mean follow up of 24 months (3.7% vs. 11.1%). The clinical outcome is not influenced by the type of IPD.

Summary

The long-term functionality of these devices is questionable, with radiologic changes and recurrence of symptoms often seen by 2 years following implantation. Next-generation devices do not appear to be subject to the same “bounce back” effect of symptom re-emergence after several years.

     

Preoperative Assessment for Ambulatory Surgery

Purpose of Review

Ambulatory surgery has grown in recent decades in volume and represents a significant number of anesthetics delivered throughout the USA. Preoperative anesthetic assessment in the ambulatory setting has become important because patients with numerous complex comorbidities are now commonplace in this arena. Disease states involving the lungs, the heart, the kidneys, and subpopulations including those who are obese and the elderly commonly receive anesthetics in an ambulatory setting.

Recent Findings

This review presents key aspects of current thinking with regard to preoperative assessment and considerations for different critical disease states and subpopulations that are now being managed under ambulatory surgery. Same day surgery centers require patient safety, and expectations are high for patient satisfaction. Advancements in surgical and anesthetic technique have allowed for more complex patients to partake in ambulatory surgery.

Summary

Anesthesiologists must be familiar with guidelines, state-of-the-art pain management, and standards of preoperative patient evaluation to accurately stratify patient risk and to advocate for patient safety.

     

Predictive factors for polypharmacy among child and adolescent psychiatry inpatients

Background

Aim was to determine the predictive factors for polypharmacy among inpatient children and adolescents with psychiatric disorders.

Methods

Blinded, case-note review of children and adolescents with ICD 10 diagnosis of psychiatric disorders on psychotropic medication was conducted. Data on demography, illness, and treatment was analyzed with univariate and multivariate techniques.

Results

Proscribing non-pharmacological interventions (OR = 4.7) and pro re nata medication (OR = 3.3), increased the risk of polypharmacy. Prescribing physical restraint reduced the risk of receiving multiple medications (OR = 0.3).

Conclusion

Proscribing non-pharmacological interventions, pro re nata medication and physical restraints increased polypharmacy.

     

Comprehensive preclinical evaluation of a multi-physics model of liver tumor radiofrequency ablation

Purpose

We aim at developing a framework for the validation of a subject-specific multi-physics model of liver tumor radiofrequency ablation (RFA).

Methods

The RFA computation becomes subject specific after several levels of personalization: geometrical and biophysical (hemodynamics, heat transfer and an extended cellular necrosis model). We present a comprehensive experimental setup combining multimodal, pre- and postoperative anatomical and functional images, as well as the interventional monitoring of intra-operative signals: the temperature and delivered power.

Results

To exploit this dataset, an efficient processing pipeline is introduced, which copes with image noise, variable resolution and anisotropy. The validation study includes twelve ablations from five healthy pig livers: a mean point-to-mesh error between predicted and actual ablation extent of 5.3 ± 3.6 mm is achieved.

Conclusion

This enables an end-to-end preclinical validation framework that considers the available dataset.

     

Tiotropium Respimat<Superscript>®</Superscript> Versus HandiHaler<Superscript>®</Superscript>: Comparison of Bronchodilator Efficacy of Various Doses in Clinical Trials

Introduction

The long-acting muscarinic antagonist tiotropium bromide is approved in many countries as maintenance therapy for chronic obstructive pulmonary disease (COPD). Tiotropium is available as a dry-powder formulation delivered via HandiHaler^® (18 μg once daily) and is now also approved as an aqueous solution delivered via the Respimat^® Soft Mist? Inhaler (5 μg once daily, 2 puffs of 2.5 µg). Several studies have compared the efficacy of tiotropium HandiHaler (18 μg once daily) with different doses of Respimat. We aimed to compare available bronchodilator efficacy data of once-daily Respimat 1.25, 2.5, 5, 10, 20 µg, and HandiHaler 18 µg to investigate which dose of tiotropium delivered by Respimat is the closest match to tiotropium HandiHaler.

Methods

Evaluation of six clinical trials (duration from 3 weeks to 2–3 years) that included lung function measures (trough forced expiratory volume in 1 s and trough forced vital capacity) as key outcomes.

Results

In the six trials, bronchodilator efficacy of Respimat 5 μg and HandiHaler 18 μg was similar; however, reduced bronchodilator efficacy was observed with lower doses of Respimat (1.25 and 2.5 μg).

Conclusion

These findings support the use of the marketed once-daily dose of Respimat 5 μg for the maintenance treatment of patients with COPD.

Funding

Boehringer Ingelheim.

     

Nasal continuous positive airway pressure decreases respiratory muscles overload in young infants with severe acute viral bronchiolitis

Objective

To determine the efficacy of nasal continuous positive airway pressure (nCPAP) on respiratory distress symptoms and respiratory effort in young infants with acute respiratory syncytial virus bronchiolitis.

Design

Prospective study.

Setting

The paediatric intensive care unit of a university hospital.

Patients

Twelve infants less than 3 months of age, with severe respiratory distress.

Interventions

Respiratory distress was quantified with a specific scoring system. Oesophageal pressure (Pes) was measured during spontaneous ventilation before and after nCPAP, delivered through an infant-adapted ventilator. Simultaneous recording of gastric pressure (Pgas) was performed in the five oldest patients.

Measurements and results

The respiratory distress score decreased after nCPAP, particularly accessory muscles’ use and expiratory wheezing. The breathing pattern was modified, with shorter inspiratory and longer expiratory time. Pes swings and PTPes_insp, two indices of inspiratory effort, were reduced by 54 (±4)% and 59 (±5)%. PTPgas_exp, an indicator of expiratory muscles activity, was completely abolished. A significant correlation was observed between the respiratory distress score and Pes swings at baseline and after nCPAP.

Conclusions

In young infants with severe acute respiratory syncytial virus bronchiolitis, nCPAP rapidly unloads respiratory muscles and improves respiratory distress symptoms.

     

Management and Outcome of Periprocedural Cardiac Perforation and Tamponade with Radiofrequency Catheter Ablation of Cardiac Arrhythmias: A Single Medium-Volume Center Experience

Introduction

Cardiac tamponade (CT) is a life-threatening complication of radiofrequency ablation (RFA). The course and outcome of CT in low-to-medium volume electrophysiology centers are underreported.

Methods

We analyzed the incidence, management and outcomes of CT in 1500 consecutive RFAs performed in our center during 2011–2016.

Results

Of 1500 RFAs performed in 1352 patients (age 55 years, interquartile range: 41–63), 569 were left-sided procedures (n = 406 with transseptal access). Conventional RFA or irrigated RFA was performed in 40.9% and 59.1% of procedures, respectively. Ablation was performed mostly for atrioventricular nodal reentrant tachycardia (25.4%), atrial fibrillation (AF; 18.5%), atrial flutter (18.4%), accessory pathway (16.5%) or idiopathic ventricular arrhythmia (VA; 12.3%), and rarely for structural VA (2.1%). CT occurred in 12 procedures (0.8%): 10 AF ablations, 1 idiopathic VA and 1 typical atrial flutter ablation. Factors significantly associated with CT were older age, pre-procedural oral anticoagulation, left-sided procedures, transseptal access, AF ablation, irrigated RFA and longer fluoroscopy time (on univariate analysis), and AF ablation (on multivariable analysis). The perforation site was located in the left atrium (n = 7), right atrium (n = 3), or in the left ventricle or coronary sinus (n = 1 each). Upon pericardiocentesis, two patients underwent urgent cardiac surgery because of continued bleeding. There was no fatal outcome. During the follow-up of 19 ± 14 months, eight patients were arrhythmia free.

Conclusion

Incidence of RFA-related CT in our medium-volume center was low and significantly associated with AF ablation. The outcome of CT was mostly favorable after pericardiocentesis, but readily accessible cardiothoracic surgery back-up should be mandatory in RFA centers.

     

OR.NET: multi-perspective qualitative evaluation of an integrated operating room based on IEEE 11073 SDC

Purpose

Clinical working environments have become very complex imposing many different tasks in diagnosis, medical treatment, and care procedures. During the German flagship project OR.NET, more than 50 partners developed technologies for an open integration of medical devices and IT systems in the operating room. The aim of the present work was to evaluate a large set of the proposed concepts from the perspectives of various stakeholders.

Method

The demonstration OR is focused on interventions from the head and neck surgery and was developed in close cooperation with surgeons and numerous colleagues of the project partners. The demonstration OR was qualitatively evaluated including technical as well as clinical aspects. In the evaluation, a questionnaire was used to obtain feedback from hospital operators. The clinical implications were covered by structured interviews with surgeons, anesthesiologists and OR staff.

Results

In the present work, we qualitatively evaluate a subset of the proposed concepts from the perspectives of various stakeholders. The feedback of the clinicians indicates that there is a need for a flexible data and control integration. The hospital operators stress the need for tools to simplify risk management in openly integrated operating rooms.

Conclusion

The implementation of openly integrated operating rooms will positively affect the surgeons, the anesthesiologists, the surgical nursing staff, as well as the technical personnel and the hospital operators. The evaluation demonstrated the need for OR integration technologies and identified the missing tools to support risk management and approval as the main barriers for future installments.

     

Efficiency of quantitative echogenicity for investigating supraspinatus tendinopathy by the gray-level histogram of two ultrasound devices

Purpose

The gray-level histogram of ultrasound is a promising tool for scanning the hypoechogenic appearance of supraspinatus tendinopathy, and the aim of this study was to test the hypothesis that the gray-level value of the supraspinatus tendon in the painful shoulder has a lower value on B-mode images even though in different ultrasound devices.

Methods

Sixty-seven patients who had unilateral shoulder pain with rotator cuff tendinopathy underwent bilateral shoulder ultrasonography, and we compared the mean gray-level values of painful shoulders and contralateral shoulders without any pain in each patient using two ultrasound devices. The echogenicity ratio (symptomatic/asymptomatic side) of two ultrasound devices was compared.

Results

A significant difference existed between the symptomatic shoulder and contralateral asymptomatic shoulder (p < 0.001) on the mean gray-level value measurements of each device. The symptomatic-to-asymptomatic tendon echogenicity ratio of device A was 0.919 ± 0.090 in the transverse plane and 0.937 ± 0.081 in the longitudinal plane, and the echogenicity ratio of device B was 0.899 ± 0.113 in the transverse plane and 0.940 ± 0.113 in the longitudinal plane.

Conclusions

The decline of the mean gray-level value and the echogenicity ratio of the supraspinatus tendon in the painful shoulder may be utilized as a useful sonographic reference of unilateral rotator cuff lesions.

Level of evidence

Diagnostic level III.