scholarly journals Performance of a multisensory implantable cardioverter-defibrillator algorithm for remote heart failure management: the RE-HEART registry

2021 ◽  
Vol 2 (4) ◽  
Author(s):  
J De Juan Baguda ◽  
M Pachon Iglesias ◽  
J J Gavira Gomez ◽  
V Martinez Mateo ◽  
M F Arcocha Torres ◽  
...  
Keyword(s):  
Heart Failure ◽  
Clinical Practice ◽  
Implantable Cardioverter Defibrillator ◽  
Phase 1 ◽  
Study Phase ◽  
Phase 2 ◽  
Office Visits ◽  
Phase 3 ◽  
Cardioverter Defibrillator ◽  
Clinical Events

Abstract Background The HeartLogic algorithm measures data from multiple implantable cardioverter-defibrillator-based (ICD) sensors and combines them into a single index. The associated alert has proved to be a sensitive and timely predictor of impending heart failure (HF) decompensation. Objective To analyze the association between HeartLogic alerts and clinical events and to describe the implementation in clinical practice of the algorithm for remote management of HF patients. Methods The association between HeartLogic alerts and clinical events has been analyzed in the blinded study Phase 1 (from ICD implantation to HeartLogic alert activation) and in the following unblinded Phase 2 and 3 (after HeartLogic activation). During Phase 1, patients were managed according to the standard clinical practice and physicians were blinded to the alert status. During Phase 2 physicians reacted to alerts according to their clinical practice, while during Phase 3 they followed a standardized protocol in response to alerts. Results We enrolled 288 patients who received HeartLogic-enabled ICD or CRT-D at 15 centers. 101 patients contributed to Phase 1. During a median observation period of 10 [95% CI: 5 – 19] months, the HeartLogic index crossed the alert-threshold value 73 times (0.72 alerts/patient-year) in 39 patients. 8 HF hospitalizations and 2 emergency room admissions occurred in 9 patients (0.10 events/patient-year) during HeartLogic IN alert state. Other 10 minor events (HF in-office visits and non-HF hospitalization) were associated with HeartLogic alerts. During the active phases 267 patients were observed for a median follow-up of 16 [95% CI: 15 – 22] months. 277 HeartLogic alerts (0.89 alerts/patient-year) occurred in 136 patients. Thirty-three HeartLogic alerts were associated with hospitalizations for HF or with HF death (n=6), and 46 alerts were associated with unplanned in-office visits for HF. In 78 cases, HeartLogic alerts were associated with other clinically relevant events. The rate of unexplained alerts was low (0.39 alerts/patient-year). During the active phases, one HF hospitalization and one unplanned in-office visit for HF occurred when patients were in OUT of alert state. Patient phone contacts or in-person assessments were performed more frequently in Phase 3 (85%) than in Phase 2 (73%; p=0.047), while alert-triggered actions were similar in the two phases. Most alerts in both Phases (82% in 2 and 81% in 3; p=0.861) were managed remotely. The total number of patient phone contacts performed during Phase 2 was 35 (0.65 contacts/patient-year) and during Phase 3 was 287 (1.12 contacts/patient-year; p=0.002). Conclusions HeartLogic index was frequently associated with HF-related clinical events, with a low rate of unexplained events. The HeartLogic alert and a standardize protocol of actions allowed to remotely detect impending decompensation events and to implement clinical actions with a low workload for the centers. Funding Acknowledgement Type of funding sources: None.

scholarly journals Remote heart failure management using a multiparameter implantable cardioverter-defibrillator alert: the multicentric RE-HEART registry

2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
J De Juan Baguda ◽  
J.J Gavira Gomez ◽  
M Pachon Iglesias ◽  
L Pena Conde ◽  
J.M Rubin Lopez ◽  
...  
Keyword(s):  
Heart Failure ◽  
Implantable Cardioverter Defibrillator ◽  
Median Duration ◽  
Office Visit ◽  
Active Phase ◽  
Cardiac Resynchronization ◽  
Office Visits ◽  
Icd Implantation ◽  
Cardioverter Defibrillator ◽  
Clinical Events

Abstract Background The HeartLogic algorithm combines multiple implantable cardioverter-defibrillator (ICD)-based sensors into an index for prediction of impending heart failure (HF) decompensation. In patients with ICD and cardiac resynchronization therapy ICD remotely monitored at 13 Spanish centers, we analyzed the association between clinical events and HeartLogic alerts and we described the use of the algorithm for the remote management of HF. Methods The association between clinical events and HeartLogic alerts was studied in the blinded phase (from ICD implantation to alert activation – no clinical actions taken in response to alerts) and in the following active phase (after alert activation – clinicians automatically notified in case of alert). Results We enrolled a total of 215 patients (67±13 years old, 77% male, 53% with ischemic cardiomyopathy) with ICD (19%) or CRT-D (81%). The median duration of the blinded phase was 8 [3–12] months. In this phase, the HeartLogic index crossed the threshold value (set by default to 16) 34 times in 20 patients. HeartLogic alerts were associated with 6 HF hospitalizations and 5 unplanned in-office visits for HF. Five additional HeartLogic threshold crossings were not associated with overt HF events, but occurred at the time of changes in drug therapy or of other clinical events. The rate of unexplained alerts was 0.25 alert-patient/year. The median time spent in alert was longer in the case of HF hospitalizations than of in-office visits (75 [min-max: 30–155] days versus 39 [min-max: 5–105] days). The maximum HeartLogic index value was 38±15 in the case of hospitalizations and 24±7 in that of minor HF events. The median duration of the following active phase was 5 [2–10] months. After HeartLogic activation, 40 alerts were reported in 26 patients. Twenty-seven (68%) alerts were associated with multiple HF- or non-HF related conditions or changes in prescribed HF therapy. Multiple actions were triggered by these alerts: HF hospitalization (4), unscheduled in-office visits (8), diuretics increase (8), change in other cardiovascular drugs (5), device reprogramming (2), atrial fibrillation ablation (1), patient education on therapy adherence (2). The rate of unexplained alerts not followed by any clinical action was 0.13 alert-patient/year. These alerts were managed remotely (device data review and phone contact), except for one alert that generated an unscheduled in-office visit. Conclusions HeartLogic index was frequently associated with HF-related clinical events. The activation of the associated alert allowed to remotely detect relevant clinical conditions and to implement clinical actions. The rate of unexplained alerts was low, and the work required in order to exclude any impending decompensation did not constitute a significant burden for the centers. Funding Acknowledgement Type of funding source: None

scholarly journals Multiparametric Implantable Cardioverter-Defibrillator Algorithm for Heart Failure Risk Stratification and Management: An Analysis in Clinical Practice

2021 ◽  
Author(s):  
Leonardo Calò ◽  
Valter Bianchi ◽  
Donatella Ferraioli ◽  
Luca Santini ◽  
Antonio Dello Russo ◽  
...  
Keyword(s):  
Heart Failure ◽  
Clinical Practice ◽  
Risk Stratification ◽  
Implantable Cardioverter Defibrillator ◽  
Hazard Ratio ◽  
Cardiac Resynchronization ◽  
Office Visits ◽  
Cardioverter Defibrillator ◽  
Increased Risk ◽  
Observation Period

Background: The HeartLogic algorithm combines multiple implantable cardioverter-defibrillator sensors to identify patients at risk of heart failure (HF) events. We sought to evaluate the risk stratification ability of this algorithm in clinical practice. We also analyzed the alert management strategies adopted in the study group and their association with the occurrence of HF events. Methods: The HeartLogic feature was activated in 366 implantable cardioverter-defibrillator and cardiac resynchronization therapy implantable cardioverter-defibrillator patients at 22 centers. The median follow-up was 11 months [25th–75th percentile: 6–16]. The HeartLogic algorithm calculates a daily HF index and identifies periods IN alert state on the basis of a configurable threshold. Results: The HeartLogic index crossed the threshold value 273 times (0.76 alerts/patient-year) in 150 patients. The time IN alert state was 11% of the total observation period. Patients experienced 36 HF hospitalizations, and 8 patients died of HF during the observation period. Thirty-five events were associated with the IN alert state (0.92 events/patient-year versus 0.03 events/patient-year in the OUT of alert state). The hazard ratio in the IN/OUT of alert state comparison was (hazard ratio, 24.53 [95% CI, 8.55–70.38], P <0.001), after adjustment for baseline clinical confounders. Alerts followed by clinical actions were associated with less HF events (hazard ratio, 0.37 [95% CI, 0.14–0.99], P =0.047). No differences in event rates were observed between in-office and remote alert management. Conclusions: This multiparametric algorithm identifies patients during periods of significantly increased risk of HF events. The rate of HF events seemed lower when clinical actions were undertaken in response to alerts. Extra in-office visits did not seem to be required to effectively manage HeartLogic alerts. REGISTRATION: URL: https://www.clinicaltrials.gov ; Unique identifier: NCT02275637.

P2872Remote management of heart failure patients with the multisensor ICD alert: preliminary results from the Italian pilot experience

2019 ◽  
Vol 40 (Supplement_1) ◽  
Author(s):  
E De Ruvo ◽  
A Capucci ◽  
L Santini ◽  
D Pecora ◽  
S Favale ◽  
...  
Keyword(s):  
Heart Failure ◽  
Clinical Practice ◽  
Active Phase ◽  
Threshold Value ◽  
Cardiac Resynchronization ◽  
Office Visits ◽  
Resynchronization Therapy ◽  
Clinical Events ◽  
Remote Management ◽  
Alert Threshold

Abstract Background The HeartLogic (Boston Scientific) index combines data from multiple implantable cardioverter-defibrillator (ICD)-based sensors and has proved to be a sensitive and timely predictor of impending heart failure (HF) decompensation. Objective To describe a preliminary experience of remote HF management of patients who received a HeartLogic-enabled ICD or cardiac resynchronization therapy ICD (CRT-D) in clinical practice. Methods The HeartLogic feature was activated in 101 patients (74 male, 71±10 years, ejection fraction 30±7%). From implantation to activation (blinded phase), the HeartLogic index trend was not available, thus no clinical actions were taken in response to it. After activation (active phase), remote data reviews and patient phone contacts were performed monthly and at the time of HeartLogic alerts (when the index crossed the nominal alert threshold value of 16), to assess the patient decompensation status. In-office visits were performed when deemed necessary. Results During the blinded phase, the HeartLogic index crossed the threshold value 24 times (over 24 person-years, 0.99 alerts/pt-year) in 16 patients. HeartLogic alerts preceded all hospitalizations and unplanned in-office visits for HF (sensitivity: 100%, median early warning: 38 days for hospitalizations, 12 days for HF visits). No clinical events were detected during or within 30 days of recovery of 10 HeartLogic alerts (unexplained alert rate: 0.41 per patient-year). Thus, the positive predictive value was 58% (14/24). During the active phase, 44 HeartLogic alerts were reported (over 46 person-years, 0.95 alerts/pt-year) in 30 patients. 26 (59%) HeartLogic alerts were judged clinically meaningful (i.e. associated with worsening of HF and/or influenced the clinician's decision to make changes to the subject's management). Conclusions In this first description of the use of HeartLogic in clinical practice, the algorithm demonstrated its ability to detect gradual worsening of HF. The results of the blinded phase of our experience favorably compare with those reported in the validation study. In the active phase, the HeartLogic index provided clinically meaningful information for the remote management of HF patients.

PENERAPAN MODEL QUANTUM LEARNING UNTUK MENINGKATKAN HASIL BELAJAR AUTOCAD SISWA KELAS X TEKNIK PEMESINAN SMK NEGERI 1 STABAT

2013 ◽  
Vol 5 (1) ◽  
Author(s):  
Abdul Hasan Saragih
Keyword(s):  
Positive Response ◽  
Phase 1 ◽  
First Grade ◽  
Learning Model ◽  
Second Phase ◽  
Phase 2 ◽  
Phase 3 ◽  
The Third ◽  
Third Phase ◽  
Quantum Learning

This classroom research was conducted on the autocad instructions to the first grade of mechinary class of SMK Negeri 1 Stabat aiming at : (1) improving the student’ archievementon autocad instructional to the student of mechinary architecture class of SMK Negeri 1 Stabat, (2) applying Quantum Learning Model to the students of mechinary class of SMK Negeri 1 Stabat, arising the positive response to autocad subject by applying Quantum Learning Model of the students of mechinary class of SMK Negeri 1 Stabat. The result shows that (1) by applying quantum learning model, the students’ achievement improves significantly. The improvement ofthe achievement of the 34 students is very satisfactory; on the first phase, 27 students passed (70.59%), 10 students failed (29.41%). On the second phase 27 students (79.41%) passed and 7 students (20.59%) failed. On the third phase 30 students (88.24%) passed and 4 students (11.76%) failed. The application of quantum learning model in SMK Negeri 1 Stabat proved satisfying. This was visible from the activeness of the students from phase 1 to 3. The activeness average of the students was 74.31% on phase 1,81.35% on phase 2, and 83.63% on phase 3. (3) The application of the quantum learning model on teaching autocad was very positively welcome by the students of mechinary class of SMK Negeri 1 Stabat. On phase 1 the improvement was 81.53% . It improved to 86.15% on phase 3. Therefore, The improvement ofstudent’ response can be categorized good.

Clinical Drug Development for the Treatment of Pulmonary Arterial Hypertension: Collaboration With the Pharmaceutical Industry and Regulatory Agencies

2010 ◽  
Vol 9 (4) ◽  
pp. 214-219
Author(s):  
Robyn J. Barst
Keyword(s):  
Clinical Trials ◽  
Pulmonary Arterial Hypertension ◽  
Drug Development ◽  
Phase 1 ◽  
Preclinical Studies ◽  
Phase 2 ◽  
Phase 3 ◽  
Preclinical Testing ◽  
New Drug ◽  
Pulmonary Arterial

Drug development is the entire process of introducing a new drug to the market. It involves drug discovery, screening, preclinical testing, an Investigational New Drug (IND) application in the US or a Clinical Trial Application (CTA) in the EU, phase 1–3 clinical trials, a New Drug Application (NDA), Food and Drug Administration (FDA) review and approval, and postapproval studies required for continuing safety evaluation. Preclinical testing assesses safety and biologic activity, phase 1 determines safety and dosage, phase 2 evaluates efficacy and side effects, and phase 3 confirms efficacy and monitors adverse effects in a larger number of patients. Postapproval studies provide additional postmarketing data. On average, it takes 15 years from preclinical studies to regulatory approval by the FDA: about 3.5–6.5 years for preclinical, 1–1.5 years for phase 1, 2 years for phase 2, 3–3.5 years for phase 3, and 1.5–2.5 years for filing the NDA and completing the FDA review process. Of approximately 5000 compounds evaluated in preclinical studies, about 5 compounds enter clinical trials, and 1 compound is approved (Tufts Center for the Study of Drug Development, 2011). Most drug development programs include approximately 35–40 phase 1 studies, 15 phase 2 studies, and 3–5 pivotal trials with more than 5000 patients enrolled. Thus, to produce safe and effective drugs in a regulated environment is a highly complex process. Against this backdrop, what is the best way to develop drugs for pulmonary arterial hypertension (PAH), an orphan disease often rapidly fatal within several years of diagnosis and in which spontaneous regression does not occur?

scholarly journals PSVI-3 Dietary supplementation with coated omega-3 fatty acids has positive effects on growth performance and nutrients digestibility in weaned pigs

2020 ◽  
Vol 98 (Supplement_3) ◽  
pp. 196-197
Author(s):  
Woo Jung Seok ◽  
Je min Ahn ◽  
Jing Hu ◽  
Dexin Dang ◽  
Yanjiao Li ◽  
...  
Keyword(s):  
Fatty Acids ◽  
Growth Performance ◽  
Phase 1 ◽  
Dietary Supplementation ◽  
Basal Diet ◽  
Phase 2 ◽  
Omega 3 ◽  
Phase 3 ◽  
Linear Effect ◽  
Weaning Pigs

Abstract The objective of this study was to evaluate the effects of dietary supplementation of coated omega-3 fatty acid (n-3 CFA) by corn cob power silica on performance of weaning pigs. A total of 200 weaned pigs [(Landrace x Yorkshire) x Duroc, average initial body weight at 6.97 ± 1.22 kg] were randomly assigned to four experimental treatments in a 6-week experiment in 3 phases as follows: CON, basal diet; 2) 0.3CFA, CON + phase 1(0.3% n-3CFA), phase 2(0.2% n-3CFA), phase 3(0.1% n-3CFA); 3) 0.6CFA, CON + phase 1(0.6% n-3CFA), phase 2(0.4% n-3CFA), phase 3(0.2% n-3CFA); 4) 0.9CFA, CON + phase 1(0.9% n-3CFA), phase 2(0.6% n-3CFA), phase 3 (0.3% n-3CFA). Each treatment had 10 replicates with 5 pigs (three gilts and two barrows) per replicate. The data were analyzed using the GLM procedure of SAS as a randomized complete block design. Pen served as the experimental unit. Linear, quadratic and cubic polynomial contrasts were used to examine effect of dietary treatment with coated n-3FA in the basal diet. Variability in the data was expressed as the standard error of means and P&lt; 0.05 was considered to statistically significant. Increasing the level of n-3CFA in the diet linearly increased ADG and G/F of pigs (Table 1). Increasing the level of n-3CFA showed a linear increment in the digestibility of DM (83.59, 84.38, 85.13, 85.89 %) whereas nitrogen digestibility (81.79, 82.38, 82.96, 83.64 %) showed a trend (linear effect, p=0.0594) at the end of experiment. The fecal lactobacillus count was increased (7.22, 7.27, 7.33, 7.35 log10cfu/g) with the increase in the supplemental level of n-3CFA (linear effect; p&lt; 0.05). However, there were no differences in the concentration of serum haptoglobin, or fecal E. coli, Clostridium and Salmonella counts despite the increase in n-3CFA levels in the diet. Supplementation of the diet with coated n-3 fatty acids positively affected growth performance and digestibility of dry matter and nitrogen, and enhanced the count of lactobacillus in weaning pigs.

scholarly journals Quality and utility of [123I]I-metaiodobenzylguanidine cardiac SPECT imaging in nondiabetic postinfarction heart failure patients qualified for implantable cardioverter defibrillator

2021 ◽  
Author(s):  
Anna Teresińska ◽  
Olgierd Woźniak ◽  
Aleksander Maciąg ◽  
Jacek Wnuk ◽  
Jarosław Jezierski ◽  
...  
Keyword(s):  
Heart Failure ◽  
Implantable Cardioverter Defibrillator ◽  
Left Lung ◽  
Spect Imaging ◽  
Cardiac Innervation ◽  
Cardiac Spect ◽  
Cardioverter Defibrillator ◽  
Planar Images ◽  
Spect Images

Abstract Objective Impaired cardiac adrenergic activity has been demonstrated in heart failure (HF) and in diabetes mellitus (DM). [123I]I-metaiodobenzylguanidine (MIBG) enables assessment of the cardiac adrenergic nervous system. Tomographic imaging of the heart is expected to be superior to planar imaging. This study aimed to determine the quality and utility of MIBG SPECT in the assessment of cardiac innervation in postinfarction HF patients without DM, qualified for implantable cardioverter defibrillator (ICD) in primary prevention of sudden cardiac death. Methods Consecutive patients receiving an ICD on the basis of contemporary guidelines were prospectively included. Planar MIBG studies were followed by SPECT. The essential analysis was based on visual assessment of the quality of SPECT images (“high”, “low” or “unacceptable”). The variables used in the further analysis were late summed defect score for SPECT images and heart-to-mediastinum rate for planar images. MIBG images were assessed independently by two experienced readers. Results Fifty postinfarction nondiabetic HF subjects were enrolled. In 13 patients (26%), the assessment of SPECT studies was impossible. In addition, in 13 of 37 patients who underwent semiquantitative SPECT evaluation, the assessment was equivocal. Altogether, in 26/50 patients (52%, 95% confidence interval 38–65%), the quality of SPECT images was unacceptable or low and was limited by low MIBG cardiac uptake and by comparatively high, interfering MIBG uptake in the neighboring structures (primarily, in the lungs). Conclusions The utility of MIBG SPECT imaging, at least with conventional imaging protocols, in the qualification of postinfarction HF patients for ICD, is limited. In approximately half of the postinfarction HF patients, SPECT assessment of cardiac innervation can be impossible or equivocal, even without additional damage from diabetic cardiac neuropathy. The criteria predisposing the patient to good-quality MIBG SPECT are: high values of LVEF from the range characterizing the patients qualified to ICD (i.e., close to 35%) and left lung uptake intensity in planar images comparable to or lower than heart uptake.

scholarly journals Dietary Inclusion of Blood Plasma with Yeast (Saccharomyces cerevisiae) Supplementation Enhanced the Growth Performance, Nutrient Digestibility, Lactobacillus Count, and Reduced Gas Emissions in Weaning Pigs

Animals ◽  
2021 ◽  
Vol 11 (3) ◽  
pp. 759
Author(s):  
Vetriselvi Sampath ◽  
Dong Heon Baek ◽  
Sureshkumar Shanmugam ◽  
In Ho Kim
Keyword(s):  
Saccharomyces Cerevisiae ◽  
Phase 1 ◽  
Average Daily Gain ◽  
Nutrient Digestibility ◽  
Phase 2 ◽  
Phase 3 ◽  
Yeast Saccharomyces Cerevisiae ◽  
Yeast Phase ◽  
Weaning Pigs ◽  
Daily Gain

This experiment was performed to examine the hypothesis that blood plasma (BP) with yeast (Saccharomyces cerevisiae) supplement in the diet of weaning pigs could provoke the growth performance, nutrient digestibility, fecal microbial, and reduce harmful gas excretion. A total of one hundred and eighty healthy piglets were taken and assigned (complete random blocks) to three dietary treatments as: Phase 1: Treatment (TRT) 1-6% BP; TRT 2-3% BP + 3% yeast; TRT 3-6% yeast. Phase 2: TRT 1-3%; BP., TRT 2-1.5% BP + 1.5% yeast; TRT 3- 3% yeast. Phase 3: TRT 1- Control (CON) (Basal diet); TRT 2- CON; TRT 3- CON for six- weeks. Each treatment had twelve replicates and five (three gilts and two barrows) pigs per pen. Dietary inclusion of BP with yeast supplementation significantly increased the body weight of piglets during phase 2 (p = 0.003) and phase 3 (p = 0.032). In addition, TRT2 group piglets had a significant improvement in average daily gain at the end of each phase and overall (p = 0.047, 0.025, 0.018 and 0.012, respectively). At phase 3, TRT2 group piglets showed a significant improvement on nutrient digestibility of dry matter (p = 0.012) and nitrogen (p = 0.040). The fecal microbiota of TRT2 group piglets showed a tendency to increase the number of Lactobacillus counts at phase 1 (p = 0.07) and phase 2 (p = 0.06) as well as, a significant improvement at phase 3 (p = 0.021). In addition, TRT2 group piglets had trend to decrease NH3 (p = 0.074) and H2S (p = 0.069) during phase 2, and significantly reduced NH3 (p = 0.038) and H2S (p = 0.046) at phase 3. However, the fecal score of piglets remains unaffected during the entire trial. At the end of phase 1 piglets’ IgG (p = 0.008) was significantly increased with the inclusion of BP with yeast supplementation. Based on the positive effects on body weight, average daily gain, nutrient digestibility, Lactobacillus count, and reduced gas emission, we suggest that dietary supplement with BP and yeast in the diet of weaned piglet could serve as an excellent alternative to antibiotics growth promoters.

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