The Impact of COVID-19 Pandemic and Lockdown Restrictions on Cardiac Implantable Device Recipients with Remote Monitoring.

From 2020, many countries have adopted several restrictions to limit the COVID-19 pandemic. The forced containment impacted on healthcare organizations and the everyday life of patients with heart disease. We prospectively analyzed data recorded from implantable defibrillators and/or cardiac resynchronization devices of Italian patients during the lockdown (LDP), post-lockdown period (PLDP) and a control period (CP) of the previous year. We analyzed device data of the period 9 March 2019-31 May 2020 of remotely monitored patients from 34 Italian centers. Patients were also categorized according to areas with high/low infection prevalence. Among 696 patients, we observed a significant drop in median activity in LDP as compared to CP that significantly increased in the PLDP, but well below CP (all p < 0.0001). The median day heart rate and heart rate variability showed a similar trend. This behavior was associated during LDP with a significant increase in the burden of atrial arrhythmias (p = 0.0150 versus CP) and of ventricular arrhythmias [6.6 vs. 1.5 per 100 patient-weeks in CP; p = 0.0026]; the latter decreased in PLDP [0.3 per 100 patient-weeks; p = 0.0035 vs. LDP]. No modifications were recorded in thoracic fluid levels. The high/low prevalence of COVID-19 infection had no significant impact. We found an increase in the arrhythmic burden in LDP coupled with a decrease in physical activity and heart rate variability, without significant modifications of transthoracic impedance, independent from COVID-19 infection prevalence. These findings suggest a negative impact of the COVID-19 pandemic, probably related to lockdown restrictions.

Changes in gut microbiota in the acute phase after spinal cord injury correlate with severity of the lesion.

After spinal cord injury (SCI), patients face many physical and psychological issues including intestinal dysfunction and comorbidities, strongly affecting quality of life. The gut microbiota has recently been suggested to influence the course of the disease in these patients. However, to date only two studies have profiled the gut microbiota in SCI patients, months after a traumatic injury. Here we characterized the gut microbiota in a large Italian SCI population, within a short time from a not only traumatic injury. Feces were collected within the first week at the rehabilitation center (no later than 60 days after SCI), and profiled by 16S rRNA gene-based next-generation sequencing. Microbial profiles were compared to those publicly available of healthy age- and gender-matched Italians, and correlated to patient metadata, including type of SCI, spinal unit location, nutrition and concomitant antibiotic therapies. The gut microbiota of SCI patients shows distinct dysbiotic signatures, i.e. increase in potentially pathogenic, pro-inflammatory and mucus-degrading bacteria, and depletion of short-chain fatty acid producers. While robust to most host variables, such dysbiosis varies by lesion level and completeness, with the most neurologically impaired patients showing an even more unbalanced microbial profile. The SCI-related gut microbiome dysbiosis is very likely secondary to injury and closely related to the degree of completeness and severity of the lesion, regardless of etiology and time interval. This microbial layout could variously contribute to increased gut permeability and inflammation, potentially predisposing patients to the onset of severe comorbidities.

Prolonged care delivery time and reduced rate of electrophysiological procedures during the lockdown period due to Covid-19 outbreak.

OBJECTIVES: The aim of this study is to demonstrate how Electrophysiology activity has been impacted by the pandemic Coronavirus disease 2019 (COVID-19). METHODS: In this multicenter retrospective study, we analyze all consecutive patients admitted for electrophysiological procedures during the COVID-19 lockdown in the Tuscany region of Italy, comparing them to patients hospitalized in the corresponding period of the previous year. RESULTS: The impact of COVID-19 on cardiac arrhythmia management was impressive, with a reduction of more than 50% in all kinds of procedures. A gender gap was observed, with a more relevant reduction for female patients. Arrhythmic urgencies requiring a device implant showed a reduced time from symptoms to first medical contact but the time from first medical contact to procedure was significantly prolonged. CONCLUSION: Hospitals need to consider how outbreaks may affect health systems beyond the immediate infection. Routine activity should be based on a risk assessment between the prompt performance of procedure and its postponement. Retrospective observational analysis such as this study could be decisive in evidence-based medicine of any future pathogen outbreak.Nonstandard Abbreviations and Acronyms PM= pacemakerICD= implantable cardioverter defibrillatorECV= electrical cardioversionEPS= electrophysiological studyAP= ablations proceduresCIED= cardiac implantable electronic devicesWCD= wearable cardioverter defibrillatorEP Lab= Electrophysiology LaboratoriesAVNRT =atrioventricular nodal reentry tachycardiaAVRT= atrioventricular reentry tachycardiaAFL= atrial flutterAF= atrial fibrillationVT= ventricular tachycardiaAT= atrial tachycardia.

Gravimetric quantitative validation of botanic impurities in feed.

BACKGROUND: Harmful botanical impurities may contaminate feed and feed materials and be a potential danger to animal or human health, or to the environment. The aim of this study was to establish rapid and sensitive methods that can be used in routine official controls to determine botanical impurities such as Datura stramonium, Ricinus communis, Crotaliaria spp., and Ambrosia spp. in animal feed and raw materials. Claviceps sclerotia were also detected in cereals, due to the similarities of the targets and the analytical procedure. Regulation (EU) 625/2017, which replaces Reg. 2004/882/EC, states that EU member states should conduct official controls in assessed and accredited laboratories and that the analytical methods must be validated before use by considering parameters such as specificity, precision, recovery, and measurement uncertainly. RESULTS AND CONCLUSION: The results demonstrate that all of the methods tested are suitable for the official quantitative analyses required by EU official legislation. © 2020 Society of Chemical Industry.

Early CSF Biomarkers and Late Functional Outcomes in Spinal Cord Injury. A Pilot Study.

Although, biomarkers are regarded as an important tool for monitoring injury severity and treatment efficacy, and for predicting clinical evolution in many neurological diseases and disorders including spinal cord injury, there is still a lack of reliable biomarkers for the assessment of clinical course and patient outcome. In this study, a biological dataset of 60 cytokines/chemokines, growth factorsm and intracellular and extracellular matrix proteins, analyzed in CSF within 24 h of injury, was used for correlation analysis with the clinical dataset of the same patients. A heat map was generated of positive and negative correlations between biomarkers and clinical rating scale scores at discharge, and between biomarkers and changes in clinical scores during the observation period. Using very stringent statistical criteria, we found 10 molecules which correlated with clinical scores at discharge, and five molecules, which correlated with changes in clinical scores. The proposed methodology may be useful for generating hypotheses regarding "predictive" and "treatment effectiveness" biomarkers, thereby suggesting potential candidates for disease-modifying therapies using a "bed-to-bench" approach.

Possible Strategies to Optimize a Biomarker Discovery Approach to Correlate with Neurological Outcome in Patients with Spinal Cord Injury: A Pilot Study.

The lack of reliable diagnostic and prognostic markers for spinal cord injured (SCI) patients is a severe obstacle in development and testing of new therapies, and it also impairs appropriate rehabilitation care. The sparse available data on the biochemical composition of cerebrospinal fluid (CSF) during the acute and/or chronic phase of the lesion provide, up until now, inconsistent results. In this pilot study, we then explored the possibility of combining a multi-parametric and bioinformatic analysis of CSF for its biological properties tested on different cells types, suitable for investigating inflammation and re-myelination. The patient enrollment was based on stringent inclusion criteria; that is, cervical and thoracic SCI trauma, CSF collection within 24 h of trauma, type of surgical approach for spine stabilization, and absence of steroid therapy before CSF collection. Eleven SCI patients and four healthy controls were included, and in three patients, CSF was also collected at 3 months after lesion. We identified 19 proteins among the 60 investigated cytokines, chemokines, growth factors, and structural biomarkers, which are transiently regulated 24 h after SCI. A bioinformatic analysis indicated that interleukin (IL)-6 and IL-10 are in the core of the interconnected net of activated proteins. Cell-based experiments indicate that CSF from SCI patients stimulates astroglia derivation from neural precursor cells, and an inverse correlation between IL-8 CSF level and oligodendrocyte precursor cells generated from neural stem cells was also observed. Results from this pilot study suggest that using a combined bioanalytic and biological approach to analyze SCI CSF at different times after injury could be a useful approach for identifying reliable diagnostic and prognostic markers in SCI.

Access to magnetic resonance imaging of patients with magnetic resonance-conditional pacemaker and implantable cardioverter-defibrillator systems: results from the Really ProMRI study.

Aims: The Really ProMRI study evaluates magnetic resonance imaging (MRI) access for patients with cardiac implantable electronic devices (CIEDs) as well as the performance of magnetic resonance (MR)-conditional leads when undergoing MRI. Methods and results: Patients either with an MR-conditional pacemaker or implantable defibrillator (ICD) system or with at least a component (device or one or more leads) from an MR-conditional system, were asked to fill in a questionnaire when they were referred to a MR scan. The rate of prescription, denial, or execution of MR examinations was evaluated in a 1-year follow-up visit. In total, 555 patients [median age (interquartile range) 72.2 (62.2-78.6); 72% male] were enrolled, 49% (270) with a pacemaker, 51% (285) with an ICD system. Five-hundred and ten patients completed the follow-up period. A total of 37 MRI referrals were reported in 35 patients, with a consequent event rate of 7.0/100 patient-years (CI, 4.9-9.7). Fourteen were denied, while 23 [66%; (CI, 48-81%)] were performed. The number of patients with MR referrals was not statistically different between pacemaker and ICD groups (21 vs. 14; P = 0.178). The rate of scans performed was higher in the pacemaker subjects (19/23 vs. 4/14, P = 0.003), while it was similar between patients with or without a complete MR-conditional system (19/30 vs. 4/7, P = 0.606). Conclusion: In this study, we reported a 7.0/100 patient-year's event rate of MR prescriptions in CIED patients. Many examinations were denied, despite MR-conditional systems, especially in ICD patients. Regulatory and cultural changes are needed to allow wider access to MR imaging in CIED patients with MR-conditional systems.

Gravimetric quantitative determination of packaging residues in feed from former food.

Valorisation of former foodstuff products (FFP) in feed is part of a long-term strategy for sustainability. An approach to valorise FFP outside the waste value chain is their use as an alternative source of feed materials, with a subsequent optimisation of the environmental impact of products. In the current practice of food production, food packaging is provided to ensure the maintenance of food quality and safety during transport and storage. One of the problems of reusing FFP is how to deal with packaging materials or remains that can become residues in the feed. The aim of this study is to propose a fast and sensitive gravimetric method, fit for routine official controls, for the determination of packaging residues in feed. The developed method can briefly be summarised as: (1) visual selection of the undesired ingredients which can be identified as remnants of packaging materials; (2) weighing of the selected materials; (3) defatting; (4) dehydration; (5) final weighing; and (6) reporting of weight and percentage. Moreover, the method has been validated through the determination of some of the parameters listed in Council Regulation 2004/882/EC (i.e., specificity, limit of quantification (LOQ), recovery, repeatability, within-laboratory reproducibility and measurement uncertainty).

Magnitude of QRS duration reduction after biventricular pacing identifies responders to cardiac resynchronization therapy.

BACKGROUND: Several studies have investigated the association between native QRS duration (QRSd) or QRS narrowing and response to biventricular pacing. However, their results have been conflicting. The aim of our study was to determine the association between the relative change in QRS narrowing index (QI) and clinical outcome and prognosis in patients who undergo cardiac resynchronization therapy (CRT) implantation. METHODS AND RESULTS: We included 311 patients in whom a CRT device was implanted in accordance with current guidelines for CRT. On implantation, the native QRS, the QRSd and the QI during CRT were measured. After 6months, 220 (71%) patients showed a 10% reduction in LVESV. The median [25th-75th] QI was 14.3% [7.2-21.4] and was significantly related to reverse remodeling (r=+0.22; 95%CI: 0.11-0.32, p=0.0001). The cut-off value of QI that best predicted LV reverse remodeling after 6months of CRT was 12.5% (sensitivity=63.6%, specificity=57.1%, area under the curve=0.633, p=0.0002). The time to the event death or cardiovascular hospitalization was significantly longer among patients with QI>12.5% (log-rank test, p=0.0155), with a hazard ratio (HR) of 0.3 [95%CI: 0.11-0.78]. In the multivariate regression model adjusted for baseline parameters, a 10% increment in QI (HR=0.61[0.44-0.83], p=0.002) remained significantly associated with CRT response. CONCLUSIONS: Patients with a larger decrease in QRSd after CRT initiation showed greater echocardiographic reverse remodeling and better outcome from death or cardiovascular hospitalization. QI is an easy-to-measure variable that could be used to predict CRT response at the time of pacing site selection or pacing configuration programming.

Interlead anatomic and electrical distance predict outcome in CRT patients.

BACKGROUND: The implantation strategy appears to play a pivotal role in determining response to cardiac resynchronization therapy (CRT). OBJECTIVE: The aim of our study was to determine the association between anatomic and electrical interlead distance and clinical outcome after CRT implantation. METHODS: We included 216 first-time CRT recipients with left bundle branch block and sinus rhythm. On implantation, the electrical interlead distance (EID), defined as the time interval between spontaneous peak R waves detected at the right ventricular (RV) and left ventricular (LV) pacing sites, was measured. The anatomic distance between the RV and LV lead tips was determined on chest radiographs. RESULTS: The mean EID was 74 ± 41 ms, and the mean horizontal corrected interlead distance (HCID) was 125 ± 73 mm. After 12 months, 87 patients (40%) displayed an improvement in their clinical composite score. The cutoff values that best predicted an improved clinical status were as follows: 84 ms for EID (area under the curve 0.59; confidence interval [CI] 0.52-0.66; P = .026) and 90 mm for HCID (area under the curve 0.62; CI 0.55-0.69; P = .004). On multivariate analysis, only EID >84 ms (hazard ratio 0.36; CI 0.14-0.89; P = .028) and HCID >90 mm (hazard ratio 0.45; CI 0.23-0.90; P = .025) were significantly associated with the composite endpoint of death or cardiovascular hospitalization. In particular, the presence of both conditions (EID <84 ms and HCID <90 mm) was associated with the highest rate of events (log-rank test P = .002). CONCLUSIONS: The interlead anatomic and electrical distance are strongly and independently associated with patient outcome after CRT implantation. The 2 measures show an additive predictive value. (CRT MORE: Cardiac Resynchronization Therapy Modular Registry; www.clinicaltrials.gov, unique identifier: NCT01573091.)

Impact of computed tomography coronary angiography on other diagnostic tests.

OBJECTIVES: Information on the impact of computed tomography coronary angiography (CTCA) on patterns of care is scarce. In particular, it is not clear if, and to what extent, its adoption actually leads to a reduction in the use of other diagnostics tools. The aim of this study was to evaluate whether the adoption of CTCA in Emilia-Romagna (an Italian region with a population of 4.4 million) had any effect on utilization rates of myocardial perfusion scintigraphy (MPS) and coronary angiography (CA). METHODS: Interrupted time series (ITS) were applied to monthly volumes of MPS and CA tests performed from 2003 to 2010, to assess trends in usage rates for those procedures before and after CTCA was adopted by all the healthcare organizations operating in the region. RESULTS: After an increase in the first year of CTCA introduction, its use remained stable over the study period. After September 2006, a significant decrease in MPS volumes (31 percent; p < .0001) and a much less tangible decrease in CA volumes (5 percent; p < .0001), were detected by ITS analyses. CONCLUSIONS: This study demonstrates that the use of CTCA had a greater impact on MPS usage rates than on CA.

Heart rate regularisation in patients with permanent atrial fibrillation implanted with a VVI(R) pacemaker.

UNLABELLED: Irregularity of ventricular cycles is a cause of haemodynamic impairment and symptoms in patients with atrial fibrillation (AF). AIM OF THE STUDY: Aim of the study was to determine the optimal pacing rate to stabilise ventricular cycle length at rest in patients with chronic AF, bradycardiac symptoms and VVI pacing. METHODS: The compensatory pause (CP) in AF, as defined by Langendorf, was used as a reference value in pacing the heart. The spontaneous mean heart rate (MHR) was assessed with the PM OFF. The CP was then calculated with the pacing rate programmed at 40 bpm. Four pacing rates were tested: rate of the CP (RCP), RCP + 5 bpm, RCP - 5 bpm and RCP - 10 bpm. RESULTS: RCP provided a good estimate of the MHR (r = 0.92). Pacing percentage (P%) was 24 +/- 15% at the pacing rate of RCP - 10 bpm, 39 +/- 19% at RCP - 5 bpm, 63 +/- 17% at RCP, and 79 +/- 19% at RCP + 5 bpm (p < 0.001). The corresponding HR modestly increased from 65 +/- 13 bpm to 66 +/- 13 bpm (p = NS), 68 +/- 13 bpm (p < 0.001) and 71 +/- 13 bpm (p < 0.001), respectively. CONCLUSION: The RCP estimates, during pacing, what the spontaneous MHR would be. Ventricular stimulation at the RCP causes a high P%, stabilising cardiac cycles with a modest increase in HR.