Clinical Composite Score Research Articles

The WiSE-CRT System Leads to Left Ventricular Remodeling and Improved Symptoms in Patients Who are Non-Responders to Epicardial CRT

Background The management of heart failure (HF) patients who are CRT non-responders (symptomatic and have no evidence of reverse LV remodelling following epicardial CRT) remains limited. Endocardial LV pacing is potentially superior to epicardial LV pacing as it allows faster electrical activation, more physiological and provides a greater selection of pacing sites enabling operators to avoid myocardial scar. The WiSE-CRT system was developed to provide endocardial LV pacing and may be particularly useful in CRT non-responders. Objectives To determine whether WiSE-CRT would improve patient outcomes in CRT non-responders. Method CRT non-responders who successfully had the WiSE-CRT system implanted were analysed. Patients were followed up for 6 months. Results 17 patients were analysed, baseline demographics: 68.2±7.9 years, 94.1% male, 41.1% ischaemic, NYHA 2.8±0.4, QRS 169.1±23.8ms and LVEF 25.6±8.0%. There were no acute complications and 1 patient developed a pocket haematoma during follow-up. 58.8% of patients had an improvement in their clinical composite score (alive, no HF hospitalisations, improvement in NYHA or patient global assessment), 53.3% had an improvement in LVESV of≥15% and 64.7% had an absolute increase in LVEF of ≥5% or improvement in LVESV of ≥15%. Conclusion The management of CRT non-responders remains difficult with limited treatment options. Our analysis has shown that in this high-risk patient group, the WiSE-CRT system results in a considerable improvement in the clinical composite score and leads to reverse left ventricular remodelling. These encouraging results suggest an important role for the WiSE-CRT system in the management of CRT non-responders.

Longest Paced versus Sensed Electrical Delay Programming in Cardiac Resynchronization Therapy Defibrillator Patients with Quadripolar LV Leads: Results from the PASED-CRT Randomized Trial

Introduction Cardiac resynchronization therapy (CRT) is a well-established treatment for patients with drug refractory heart failure. The PASED-CRT trial (NCT-02803775) compared the efficacy of the longest RVsense to LVsense activation time (sLAT) versus the longest RVpace to LVsense activation time (pLAT) as the site of the LV pacing cathode on quadripolar LV leads. Methods The PASED-CRT trial is a single site, double blind, randomized, prospective trial. Patients were randomized to sLAT or pLAT in a 1:1 ratio. The site of Left ventricular pacing was programmed bases on the longest electrical delay measured and maintained thru 3 months. Blinded physicians and assessors compared the 6-minute hall walk test (6MWT), NYHA, MLWHF, and Clinical Composite Score (CCS) at 3 months. Results N=92 patients (20%F) 66 (±11.3 years) were randomized and programmed per protocol. Patients and physicians were blinded to programming assignment. Baseline patient characteristics were comparable between groups. N=38 sLAT and N=34 pLAT completed the 3 month visit for the final analysis. The pLAT group had a greater CCS compared 82.4% vs. the sLAT 55.3% (P=0.016) and had a mean 20.63m increase over the sLAT in 6MWT distance at 3 months. (P=N/S) Conclusions Utilizing the pLAT demonstrated improved 6MWT distance and a significant difference in CCS over the programming to the sLAT. These results should be considered in patients with intrinsic conduction and those without as no measurement is currently available. Future studies with longer follow-ups are warranted to confirm these findings.

The WiSE-CRT System Results in Left Ventricular Remodelling and Improved Symptoms in Patients Undergoing CRT Upgrades

Background Patients undergoing CRT upgrades are more likely to suffer from severe heart failure (HF) and less likely to show reverse LV remodelling than patients undergoing de novoimplants. WiSE-CRT provides endocardial pacing and has many advantages over epicardial CRT, which may result in higher rates of clinical and echocardiographic response following CRT upgrades. Objectives To determine whether WiSE-CRT would improve outcomes in patients undergoing CRT upgrades. Method All patients undergoing a CRT upgrade with WiSE-CRT were analysed. Patients were followed-up for 6 months and considered CRT responders if (A) they had an improvement in LVESV≥15% and (B) had improvement in clinical composite score (CCS); alive, no HF hospitalisations, improvement in NYHA or improvement in global assessment. Results 38 patients analysed, demographics: 68.1±11.3 years, 84.2% male and 60.5% non-ischaemic. All patients had the system successfully implanted, no major complications and 1 (2.6%) patient developed a pneumothorax treated conservatively. During follow-up, 2 patients died from cardiovascular causes, 1 patient withdrew from the study and all the remaining patients had successful biventricular pacing. Following WiSE-CRT there was a significant improvement in NYHA (2.4±0.6 vs. 2.0±0.7, p=0.002) and LV remodelling (Figure 1). 74.3% of patients had improvement in CCS and 66.7% had improvement in LVESV≥15%,. Conclusion Patients undergoing CRT upgrades with a WiSE-CRT have excellent outcomes with evidence of reverse LV remodelling and clinical improvement. Further studies are required to directly compare outcomes between epicardial and endocardial CRT upgrades.

Patients Undergoing High-Risk CRT Upgrades with a WiSE-CRT System Have at Trend towards Improved Left Ventricular Remodelling Compared with Epicardial CRT Upgrades

Background Heart failure (HF) patients undergoing CRT upgrades are more symptomatic and have lower rates of reverse LV remodelling compared with de novo implants. WiSE-CRT delivers endocardial LV pacing and has many advantages over epicardial CRT which can be particularly useful in this upgrade population. Currently, WiSE-CRT is reserved for patients considered high risk for epicardial CRT such as venous occlusion, risk of pocket infection and multiple co-morbidities placing patients at an increased risk. Objectives To determine whether patients undergoing high-risk CRT upgrades with WiSE-CRT had at least comparable outcomes to epicardial CRT upgrades. Methods Consecutive patients undergoing epicardial CRT upgrades at Guy's and St Thomas’ between 2014-2018 were compared with patients undergoing high-risk CRT upgrades with a WiSE-CRT. Results 95 patients were included; 58 epicardial and 37 endocardial CRT. Baseline demographics for epicardial vs. endocardial CRT upgrades include: 71.2±12.2 vs. 67.9±11.4 years (p=0.098), 77.6±0.4 vs. 83.8±0.4% (p=0.023) male, 39.7±0.5 vs. 37.8±0.5% (p=0.859) ischaemic, QRS 176.3±27.5 vs. 182.4±29.0ms (p=0.315) and LVEF 30.2±8.2 vs. 29.7±7.9% (p=0.796). At 6 month follow-up, epicardial CRT upgrades had an 81% improvement in clinical composite score (alive, no HF hospitalisations, improvement in NYHA or global assessment) and 78% had improvement following WiSE-CRT (p=0.784). There was a trend towards a non-significant improvement in LV remodelling following WiSE-CRT compared with epicardial CRT; 73.5±0.4 vs. 66.0±0.5% (p=0.367) of patients had an absolute change in LVEF≥5% and 69.0±0.5 vs. 52.8±0.5% (p=0.185) of patients had improvement in LVESV≥15%. Conclusion Patients undergoing high-risk CRT upgrades with WiSE-CRT have comparable outcomes with those patients undergoing epicardial CRT upgrades. There is a tendency towards improved LV remodelling following WiSE-CRT, however further studies are required to determine if this reaches significance in a larger patient cohort.

Biomarkers of Systemic Inflammation in Ugandan Infants and Children Hospitalized With Respiratory Syncytial Virus Infection.

Optimizing outcomes in respiratory syncytial virus (RSV) pneumonia requires accurate diagnosis and determination of severity that, in resource-limited settings, is often based on clinical assessment alone. We describe host inflammatory biomarkers and clinical outcomes among children hospitalized with RSV lower respiratory tract infection (LRTI) in Uganda and controls with rhinovirus and pneumococcal pneumonia. 58 children hospitalized with LRTI were included. We compared 37 patients with RSV, 10 control patients with rhinovirus and 11 control patients with suspected pneumococcal pneumonia. Patients in the RSV group had significantly lower levels of C-reactive protein (CRP) and chitinase-3-like protein 1 (CHI3L1) than the pneumococcal pneumonia group (P < 0.05 for both). Among children with RSV, higher admission levels of CRP predicted prolonged time to resolution of tachypnea, tachycardia and fever. Higher levels of CHI3L1 were associated with higher composite clinical severity scores and predicted prolonged time to resolution of tachypnea and tachycardia, time to wean oxygen and time to sit. Higher levels of lipocalin-2 (LCN2) predicted prolonged time to resolution of tachypnea, tachycardia and time to feed. Higher admission levels of all 3 biomarkers were predictive of a higher total volume of oxygen administered during hospitalization (P < 0.05 for all comparisons). Of note, CHI3L1 and LCN2 appeared to predict clinical outcomes more accurately than CRP, the inflammatory biomarker most widely used in clinical practice. Our findings suggest that CHI3L1 and LCN2 may be clinically informative biomarkers in childhood RSV LRTI in low-resource settings.

Factors Predicting Difficult Endotracheal Intubation.

Factors Predicting Difficult Endotracheal Intubation.

Six versus two weeks treatment with doxycycline in Lyme neuroborreliosis: the protocol of a multicentre, non-inferiority, double-blinded and randomised controlled trial

IntroductionCurrent treatment guidelines for European Lyme neuroborreliosis (LNB) recommend cephalosporins, penicillin or doxycycline for 14–28 days but evidence for optimal treatment length is poor. Treatment lengths in clinical practice tend...

Thyroid Peroxidase Antibody among Hypothyroid Patients and Clinical and Biochemical Response to L-Thyroxine Replacement Therapy

This study was carried out in the Department of Medicine, Rajshahi Medical College, in 2006-2007 to study the thyroid peroxidase (TPO) antibody level among hypothyroid patients and to find out the effects of L-thyroxine therapy in TPO-antibody titer. After thorough physical examination and relevant investigations, 100 patients of hypothyroidism were enrolled in this study. The selected patients were given L-thyroxine replacement therapy at a dose of 50-150 microgram/d. Before starting L-thyroxine, serum was collected from all patients to estimate anti TPO-antibody level. All patients were followed-up after 12-28 weeks of full dose of L-thyroxine therapy. Patients with high TPO-Abs at baseline, only 17.6% turned into euthyroid (based on composite clinical score), whereas about 42% of the patients who did not have high TPO-Abs became euthyroid suggesting that patients with high TPO Abs may show significantly poor response to treatment compared to the patients without high TPO Abs (p &lt; 0.001). Patients with high TPO-Ab titers also showed a decreased biochemical response (TSH values) compared to the patients without high TPO-Ab positive patients. So, TPO-Ab plays a significant role in causation of the disease and is also associated with poor treatment response with L-thyroxine replacement therapy.&#x0D; TAJ 2018; 31(2): 45-49

Design and rationale for the Stimulation Of the Left Ventricular Endocardium for Cardiac Resynchronization Therapy in non-responders and previously untreatable patients (SOLVE-CRT) trial

Cardiac resynchronization therapy (CRT) improves outcomes, functional capacity and quality of life in patients with heart failure. Despite two decades of experience with CRT, the rate of non-response remains approximately 30%. CRT efficacy is impacted by pacing location, which is anatomically limited in conventional systems. A new wireless endocardial left ventricular (LV) pacing system allows CRT without such limitations and has shown promise in open-label studies. The purpose of this study is to evaluate its use in a patient population with poor therapeutic alternatives. The SOLVE CRT study is an international, multi-center, randomized, double-blind, sham-controlled trial of patients with Class I and IIa indications for CRT who have either failed to respond to or have been unable to receive conventional CRT. Enrollment will comprise 350 patients implanted with the wireless CRT system randomized 1:1 to therapy on (Treatment) or therapy off (Control) for the six-month period over which trial primary endpoints will be evaluated. The primary safety endpoint will measure the proportion of patients free from system- and procedure-related complications. Primary efficacy endpoints will assess absolute change in LV end-systolic volume LVESV, proportion of patients reducing LVESV by ≥15% and clinical composite score for Treatment versus Control patients. Primary endpoints will be evaluated on an intention-to-treat basis, though per-protocol and as-treated analysis will also be performed. SOLVE-CRT will quantify the safety and effectiveness of wireless CRT in non-responders to conventional CRT and indicated patients who have been unable to receive CRT via the usual transvenous approach.

Implant-based multi-parameter telemonitoring of patients with heart failure and a defibrillator with vs. without cardiac resynchronization therapy option: a subanalysis of the IN-TIME trial

AimsIn the IN-TIME trial, automatic daily implant-based multiparameter telemonitoring significantly improved clinical outcomes in patients with chronic systolic heart failure and implantable cardioverter-defibrillator (ICD) or cardiac resynchronization therapy defibrillator (CRT-D). We compared IN-TIME results for ICD and CRT-D subgroups.MethodsPatients with LVEF ≤ 35%, NYHA class II/III, optimized drug treatment, no permanent atrial fibrillation, and a dual-chamber ICD (n = 274) or CRT-D (n = 390) were randomized 1:1 to telemonitoring or no telemonitoring for 12 months. Primary outcome measure was a composite clinical score, classified as worsened if the patient died or had heart failure-related hospitalization, worse NYHA class, or a worse self-reported overall condition.ResultsThe prevalence of worsened score at study end was higher in CRT-D than ICD patients (26.4% vs. 18.2%; P = 0.014), as was mortality (7.4% vs. 4.1%; P = 0.069). With telemonitoring, odds ratios (OR) for worsened score and hazard ratios (HR) for mortality were similar in the ICD [OR = 0.55 (P = 0.058), HR = 0.39 (P = 0.17)] and CRT-D [OR = 0.68 (P = 0.10), HR = 0.35 (P = 0.018)] subgroups (insignificant interaction, P = 0.58–0.91).ConclusionDaily multiparameter telemonitoring has a potential to reduce clinical endpoints in patients with chronic systolic heart failure both in ICD and CRT-D subgroups. The absolute benefit seems to be higher in higher-risk populations with worse prognosis.

Handheld Point-of-Care Lactate Measurement at Admission Predicts Mortality in Ugandan Children Hospitalized with Pneumonia: A Prospective Cohort Study.

Globally, pneumonia is the leading cause of death among children younger than 5 years old, with most deaths occurring in low-income countries. Rapid bedside tools to assist practitioners to accurately triage and risk-stratify these patients may improve clinical care and patient outcomes. We conducted a prospective cohort study of children with pneumonia admitted to two Ugandan hospitals to examine the predictive value of a single point-of-care lactate measurement using a commercially available handheld device, the Lactate Scout Analyzer. One hundred and fifty-five children were included, 90 (58%) male, with a median (interquartile range [IQR]) age of 11 (1.4-20) months. One hundred and twenty-five (81%) patients had chest indrawing, 133 (86%) were hypoxemic, and 75 (68%) had a chest x-ray abnormality. In-hospital mortality was 22/155 (14%). Median (IQR) admission lactate level was 2.4 (1.8-3.6) mmol/L among children who survived versus 7.2 (2.6-9.7) mmol/L among those who died (P < 0.001). Lactate was a better prognostic marker of mortality (area under receiver operator characteristic 0.76, 95% confidence interval: 0.69-0.87, P ≤ 0.001), than any single clinical sign or composite clinical risk score. Lactate level at admission of < 2.0, 2.0-4.0, and > 4.0 mmol/L accurately risk-stratified children, with 5-day mortality of 2%, 11% and 26%, respectively (P < 0.001). Slow lactate clearance also predicted subsequent mortality in children with repeated lactate measurements. Hand-held lactate measurement is a clinically informative and convenient tool in low-resource settings for triage and risk stratification of pediatric pneumonia.

Absence of correlation between DAS28-ESR, DAS28-CRP, SDAI, CDAI and ultrasound scoring in patients with rheumatoid arthritis in remission

Objective: Several composite scores (28-joints Disease Activity Score (DAS28), Simplified/Clinical Disease Activity Index (SDAI/CDAI)) may be used as target of therapeutic strategies in rheumatoid arthritis (RA) management. Although ultrasound (US) is a useful imaging technique in RA management, there are no validated US remission criteria. We aimed at analyzing correlations between US and clinical scores in RA patients with clinical remission. Methods: This French multicenter cross-sectional study, in 11 Rheumatology departments, consecutively included patients from August 2015 to April 2016. Inclusions criteria were: RA diagnosis meeting ACREULAR 2010 criteria, <15 years of progression, DAS28-ESR<2.6 for at least 3 months, stable treatment for at least 6 months, including steroids if necessary. Correlations between US scores (Naredo12 B-mode, PD-mode, combined B+PD mode, PDUS scores) and clinical remission composite scores (DAS28-ESR (Erythrocyte Sedimentation Rate), DAS28-CRP (C Reactive Protein), SDAI, CDAI) were analyzed. Results: 225 patients were analyzed. Intra/inter-observer reliabilities were good to excellent. Correlations between clinical and US Naredo12 scores were weak to moderate, with correlation coefficients ranging from 0.086 [-0.05; 0.21] to 0.323 [0.20; 0.44]. Best correlations were observed between PD-mode and SDAI or CDAI. US Naredo12 PD-mode score of 0/36 predicts a SDAI remission with 78% sensitivity and 49% specificity (area under curve 0.65). No association was found between US Naredo12 scores and type of treatment, remission duration or disease duration. Conclusions: There is no strong correlation between US and clinical scores in remission RA patients in routine care. US input in the definition of RA remission remains uncertain.

Preliminary Validation of the Digital Ulcer Clinical Assessment Score in Systemic Sclerosis.

To date, "healed/non-healed" and clinical judgment are the only available assessment tools for digital ulcers (DU) in patients with systemic sclerosis (SSc). The aim of our study is to examine a preliminary composite DU clinical assessment score (DUCAS) for SSc for face, content, and construct validity. Patients with SSc presenting at least 1 finger DU were enrolled and assessed with the Health Assessment Questionnaire-Disability Index, Cochin scale, visual analog scale (VAS) for DU-related pain, patient global DU status, and global assessment as patient-reported outcomes (PRO), and physician VAS for DU status (phyGDU) as an SSc-DU expert physician/nurse measure. The DUCAS included 7 DU-related variables selected by a committee of SSc DU experts and weighted on a clinical basis. Face validity was examined by consensus and partial construct validity was tested through convergent correlation with other measures of hand function, using Spearman's correlations. A range of patients with SSc was examined. A linear regression model with backward stepwise analysis was used to determine the relationship of individual variables with the primary clinical parameter, phyGDU. Forty-four patients with SSc (9 males, mean age 55 ± 15 yrs, mean disease duration 9.9 ± 5.8 yrs) were enrolled in the study. Overall DUCAS showed significant positive correlations with all abovementioned PRO (r > 0.4, p < 0.01). When all scores and scales were modeled, only DUCAS significantly predicted phyGDU (r = 0.59, R2 = 0.354, Akaike information criterion = 385.4). Preliminarily, we suggest that the DUCAS may be a new clinical score for SSc-related DU, having face and content validity and convergent/divergent correlations (construct validity). These early data suggest that this score deserves further evaluation.

EEG, behavioural and physiological recordings following a painful procedure in human neonates

We present a dataset of cortical, behavioural, and physiological responses following a single, clinically required noxious stimulus in a neonatal sample. Cortical activity was recorded from 112 neonates (29–47 weeks gestational age at study) using a 20-channel electroencephalogram (EEG), which was time-locked to a heel lance. This data is linked to pain-related behaviour (facial expression), physiology (heart rate, oxygenation) and a composite clinical score (Premature Infant Pain Profile, PIPP). The dataset includes responses to non-noxious sham and auditory controls. The infants’ relevant medical and pain history was collected up to the day of the study and recorded in an extensive database of variables including clinical condition at birth, diagnoses, medications, previous painful procedures, injuries, and selected maternal information. This dataset can be used to investigate the cortical, physiological, and behavioural pain-related processing in human infants and to evaluate the impact of medical conditions and experiences upon the infant response to noxious stimuli. Furthermore, it provides information on the formation of individual pain phenotypes.

DAPSA and ultrasound show different perspectives of psoriatic arthritis disease activity: results from a 12-month longitudinal observational study in patients starting treatment with biological disease-modifying antirheumatic drugs

ObjectivesDisease Activity index for PSoriatic Arthritis (DAPSA) (sum score 68/66 tender/swollen joint counts (68TJC/66SJC), patient’s global assessment, pain and C-reactive protein (CRP)) is recommended for clinical assessment of disease activity...

Rationale and design for ENHANCE CRT: QLV implant strategy for non-left bundle branch block patients.

AimsHistorically, cardiac resynchronization therapy (CRT) response in non‐left bundle branch block (non‐LBBB) patients has been suboptimal in comparison with that observed in left bundle branch block patients. The electrical activation pattern of the left ventricle (LV) is different between these two QRS morphologies. Small non‐randomized studies have suggested that targeting the LV wall with greatest electrical delay may be superior to conventional anatomical pacing from the lateral wall in non‐LBBB patients. This article outlines the design and rationale of a prospective, randomized, pilot study, which assesses the effect of a non‐traditional LV lead implant strategy on the clinical composite score after 12 months of follow‐up in a non‐LBBB patient population.MethodsAll patients will receive an Abbott quadripolar CRT‐D system (Quartet 1458Q LV lead with Unify Quadra™, Quadra Assura™ CRT‐D or any market‐approved CRT‐D device with quadripolar pacing capabilities). Patients will be randomized in a 2:1 ratio between a QLV‐based implant strategy vs. standard of care. Up to 250 patients will be enrolled in the study.ConclusionsIf the primary endpoint is achieved, this study will provide important information about reducing the non‐responder rate in non‐LBBB patients and provide further evidence for the QLV‐based implant strategy.

Cardiac resynchronization therapy is associated with improvement in clinical outcomes in Indian heart failure patients: Results of a large, long-term observational study

BackgroundHeart failure (HF) is a common health problem in South Asia, and its incidence and prevalence are projected to rise. Cardiac resynchronization therapy (CRT) has been shown to improve mortality, reduce hospitalizations, and improve symptoms in selected patients with HF. The South Asian Systolic Heart Failure Registry (SASHFR) was designed to be a large and comprehensive registry of Indian HF patients with the purpose of enhancing the quality of care and clinical outcomes of HF patients by promoting the adoption of evidence-based, guideline-recommended therapies, in particular CRT. MethodsOverall, 471 patients on optimized medical therapy and meeting CRT implantation guidelines were followed up in 12 Indian hospitals. During the 2-year follow-up period, clinical response in terms of clinical composite score, overall performance and changes in HF performance metrics, mortality and hospitalizations rates were evaluated. ResultsOf 471 patients, 116 (24.6%) accepted to be implanted with a CRT device, while 355 (75.4%) refused, financial constraints being the main reason for refusing a CRT device. The study met its primary outcome, as the number of patients associated with an improvement in clinical composite score at 24 months was significantly higher (69.1%) in the CRT group than in the no-CRT group (44.7%) [odds ratio = 2 (95% confidence interval 1.25–3.20), p = 0.004]. Also, changes in HF metrics, mortality and hospitalizations rates indicated a more favorable response among patients who underwent CRT. ConclusionsThe results from the SASHFR registry show a clear superiority of CRT over optimal pharmacological therapy in terms of improvement in clinical conditions among HF patients. The low rate of CRT acceptance, in patients indicated to this therapy, highlights the need for new health-care policies to improve awareness about HF disease and its therapies and possibly to enhance financial coverage of indicated therapies.

The impact of physical exercise on neuromuscular function in Myasthenia gravis patients: A single-subject design study.

There is a need for tailored exercise recommendations to patients with Myasthenia gravis (MG). A few pilot studies have recently shown that physical exercise in accordance with general recommendations to healthy adults can be applied safely to patients with mild MG symptoms. How physical exercise affects muscle parameters and risk factors for lifestyle diseases in patients with MG is, however, only poorly known. We evaluated functional skeletal muscle parameters in 11 MG patients, before and after conducting a 12-week supervised physical therapy regimen of aerobic and resistance strength training. After the training program, parameters of the rectus femoris muscle improved: compound motor action potential (from 4.5 ± 2.6 to 5.3 ± 2.8 mV, P = .016), isometric muscle force (from 25.2 ± 4.4 to 30.2 ± 3.8 kg; P = .014), and ultrasound muscle thickness (from 19.6 ± 5.6 to 23.0 ± 3.9 mm, P = .0098) all increased. Further, physical performance based measures improved, including the 30-Second Chair Stand Test (median change +2, P = .0039) as well as the clinical MG composite score [from 3 (2–5) to 2 (0–4), P = .043]. No improvement in muscle function was observed in the biceps brachii muscle. These findings indicate that MG patients can improve their muscular functions by incorporating aerobic and resistance strength training, especially in proximal leg muscles. This is important knowledge when physical therapy is considered for this patient group, for whom no guidelines on physical exercise currently exist.

Remote monitoring and clinical outcomes: details on information flow and workflow in the IN-TIME study.

AimsRandomized clinical trials investigating a possible outcome effect of remote monitoring in patients with implantable defibrillators have shown conflicting results. This study analyses the information flow and workflow details from the IN-TIME study and discusses whether differences of message content, information speed and completeness, and workflow may contribute to the heterogeneous results.Methods and resultsIN-TIME randomized 664 patients with an implantable cardioverter/defibrillator indication to daily remote monitoring vs. control. After 12 months, a composite clinical score and all-cause mortality were improved in the remote monitoring arm. Messages were received on 83.1% of out-of-hospital days. Daily transmissions were interrupted 2.3 times per patient-year for more than 3 days. During 1 year, absolute transmission success declined by 3.3%. Information on medical events was available after 1 day (3 days) in 83.1% (94.3%) of the cases. On all working days, a central monitoring unit informed investigators of protocol defined events. Investigators contacted patients with a median delay of 1 day and arranged follow-ups, the majority of which took place within 1 week of the event being available.ConclusionOnly limited data on the information flow and workflow have been published from other studies which failed to improve outcome. However, a comparison of those data to IN-TIME suggest that the ability to see a patient early after clinical events may be inferior to the set-up in IN-TIME. These differences may be responsible for the heterogeneity found in clinical effectiveness of remote monitoring concepts.

Response to cardiac resynchronization therapy is determined by intrinsic electrical substrate rather than by its modification

BackgroundElectrocardiographic mapping (ECM) expresses electrical substrate through magnitude and direction of the activation delay vector (ADV). We investigated to what extent the response to cardiac resynchronization therapy (CRT) is determined by baseline ADV and by ADV modification through CRT and optimization of left ventricular (LV) pacing site. MethodsECM was performed in 79 heart failure patients (4 RBBB, 12 QRS < 120 ms, 23 non-specific conduction delay [NICD] and 40 left bundle branch block [LBBB]). 67 patients (QRS ≥ 120 ms) underwent CRT implantation and in 26 patients multiple LV pacing site optimization was performed. ADV was calculated from locations/depolarization times of 2000 virtual epicardial electrodes derived from ECM. Acute response was defined as ≥10% LVdP/dtmax increase, chronic response by composite clinical score at 6 months. ResultsDuring intrinsic conduction, ADV direction was similar in patients with QRS < 120 ms, NICD and LBBB, pointing towards the LV free wall, while ADV magnitude was larger in LBBB (117 ± 25 ms) than in NICD (70 ± 29 ms, P < 0.05) and QRS < 120 ms (52 ± 14 ms, P < 0.05). Intrinsic ADV accurately predicted the acute (AUC = 0.93) and chronic (AUC = 0.90) response to CRT. ADV change by CRT only moderately predicted response (highest AUC = 0.76). LV pacing site optimization had limited effects: +3 ± 4% LVdP/dtmax when compared to conventional basolateral LV pacing. ConclusionThe baseline electrical substrate, adequately measured by ADV amplitude, strongly determines acute and chronic CRT response, while the extent of its modification by conventional CRT or by varying LV pacing sites has limited effects.