Total artificial heart
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BACKGROUND: Aveir DR (Abbott, Abbott Park, IL) is a dual-chamber leadless pacemaker (LP) system with distinct atrial and ventricular LPs (ALP, VLP) that communicate wirelessly to deliver atrioventricular synchronous pacing. Success rates of these implant-to-implant (i2i) transmissions have not been systematically evaluated. OBJECTIVE: This study aims to evaluate chronic i2i success rates in a clinical setting. METHODS: Patients meeting standard dual-chamber pacing indications were enrolled and implanted with dual-chamber LP systems as part of a prospective international clinical trial (Aveir DR i2i Study). The percent of successful i2i transmissions from ALP-to-VLP (A-to-V) and VLP-to-ALP (V-to-A) were interrogated from LPs in de novo patients using the device programmer at implant, discharge, and at 1, 3, and 6 months postimplant (1M, 3M, 6M). RESULTS: A total of 399 patients completed device implant and i2i diagnostic interrogation (62% male; age 69 years; 65% sinus node dysfunction, 32% atrioventricular [AV] block). Median A-to-V and V-to-A i2i success rates exceeded 90% of beats at all time-points from implant to 6M. The minority of patients with A-to-V or V-to-A i2i success in <70% of beats at implant (A-to-V: 19% of patients, V-to-A: 31% of patients) showed roughly 40% improvement by 1M, with this minority dropping to roughly 5% of patients by 6M. Improvement in i2i communication success may be attributed to reprogramming of i2i setting levels, natural changes in dominant posture, and device stabilization. CONCLUSION: Wireless implant-to-implant communication in the new dual-chamber leadless pacemaker system demonstrated successful transmissions in >90% of beats throughout the 6-month evaluation period. Communication success improved significantly over time postimplant for specific subgroups. CLINICAL TRIAL REGISTRATION: Aveir DR i2i Study, ClinicalTrials.gov ID NCT05252702.
- MeSH
- bezdrátová technologie MeSH
- design vybavení * MeSH
- kardiostimulace umělá metody MeSH
- kardiostimulátor * MeSH
- lidé středního věku MeSH
- lidé MeSH
- následné studie MeSH
- prospektivní studie MeSH
- senioři MeSH
- Check Tag
- lidé středního věku MeSH
- lidé MeSH
- mužské pohlaví MeSH
- senioři MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- multicentrická studie MeSH
Pole indikací k zavedení kardiostimulátoru pacientovi se stále vylepšuje stejně jako ošetřovatelská péče o pacienta. Protože je celý výkon nyní prakticky rutinní záležitostí kardiologů, celý proces od příjmu pacienta do zdravotnického zařízení až po jeho propuštění se výrazně urychlil. Pacient bez přítomných komplikací nebývá hospitalizován více než 3 dny a celkem se u pacienta vystřídají až tři ošetřovatelské týmy. Pacient prochází předoperační přípravou, perioperační péčí a pooperační péčí. Celý proces obsahuje dílčí kroky, které na sebe navazují, a právě celé toto spektrum výkonů činí tento zákrok velmi rychlým a pacient tak odchází stabilizován, edukován a připraven do života s implantovaným kardiostimulátorem. Tento příspěvek mapuje roli ošetřovatelského týmu a cestu pacienta. Cílem je poukázat na velké množství zásadních úkonů, bez kterých se péče neobejde a které jsou zároveň nutné ke snížení výskytu komplikací. Výsledky studie jsou rozděleny do čtyř zásadních oblastí, které poskytují vhled do celé problematiky, vč. jednotlivých úkonů dispenzarizační péče a edukace pacienta.
The field of indications for implanting a cardiac pacemaker in a patient is constantly improving, as is the patient’s nursing care. Since the entire procedure is now practically routine for cardiologists, the entire process from the patient’s admission to the medical facility to discharge has been significantly accelerated. A patient without complications is usually hospitalized for less than 3 days, and a total of up to three nursing teams take turns for the patient. The patient undergoes pre-operative preparation, peri-operative care, and post-operative care. The entire process includes sub-steps that follow each other, and it is this entire spectrum of procedures that makes this procedure very fast, and the patient leaves stabilized, educated, and ready for life with an implanted pacemaker. This post maps the role of the nursing team and the patient journey. The aim is to point out many essential actions without which care cannot be done and which are also necessary to reduce complications. The results of the study are divided into four fundamental areas that provide insight into the entire issue, including individual actions as well as dispensary care and patient education.
AIMS: A dual-chamber leadless pacemaker (LP) system that employs distinct atrial and ventricular LP devices (ALP, VLP) has been introduced to clinical practice. Proprietary, low-energy, implant-to-implant (i2i) communication at each beat enables the devices to maintain synchronous atrioventricular sensing and pacing. We evaluated device longevities and contributing factors, such as i2i communication. METHODS AND RESULTS: Patients meeting dual-chamber pacing indications received the dual-chamber LP system as part of a prospective, multi-centre, international clinical trial (Aveir DR i2i Study, NCT05252702). Programming and diagnostics were interrogated from all de novo, non-revised, dual-chamber programmed devices at 12 months post-implant. This analysis included 302 patients (65% male; age 70 ± 13 years; weight 80 ± 19 kg; intrinsic heart rate 55 ± 7 bpm; 58% sinus node dysfunction, 27% atrioventricular block). At 12 months, devices were programmed to dual-chamber pacing (DDD(R) or DDI(R)) at a median 60 bpm rate, median 1.25 V pulse amplitude in ALP and 1.5 V in VLP, median 0.4 ms pulse width, and median i2i signal setting level 5 out of 7. Median ALP and VLP remaining battery longevities at 12 months were 4.3 and 9.1 years, with median total ALP and VLP longevities of 5.3 and 9.9 years. Base rate, pulse amplitude, pacing percentage, event rate, impedance, and i2i setting level all exhibited significant correlations with ALP and VLP longevities (P < 0.001). Programming i2i setting levels below 7 produced the greatest longevity savings. CONCLUSION: The first dual-chamber LP demonstrated adequate projected battery longevity after 12 months of use. Patient-specific device programming considerations, unique to leadless devices, may extend longevity.
- MeSH
- atrioventrikulární blokáda terapie diagnóza patofyziologie MeSH
- časové faktory MeSH
- design vybavení MeSH
- kardiostimulace umělá * metody MeSH
- kardiostimulátor * MeSH
- lidé středního věku MeSH
- lidé MeSH
- prospektivní studie MeSH
- senioři nad 80 let MeSH
- senioři MeSH
- srdeční arytmie * terapie diagnóza patofyziologie MeSH
- srdeční frekvence MeSH
- výsledek terapie MeSH
- zdroje elektrické energie * MeSH
- Check Tag
- lidé středního věku MeSH
- lidé MeSH
- mužské pohlaví MeSH
- senioři nad 80 let MeSH
- senioři MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- klinické zkoušky MeSH
- multicentrická studie MeSH
BACKGROUND: Subtle, prognostically important ECG features may not be apparent to physicians. In the course of supervised machine learning, thousands of ECG features are identified. These are not limited to conventional ECG parameters and morphology. We aimed to investigate whether neural network-derived ECG features could be used to predict future cardiovascular disease and mortality and have phenotypic and genotypic associations. METHODS: We extracted 5120 neural network-derived ECG features from an artificial intelligence-enabled ECG model trained for 6 simple diagnoses and applied unsupervised machine learning to identify 3 phenogroups. Using the identified phenogroups, we externally validated our findings in 5 diverse cohorts from the United States, Brazil, and the United Kingdom. Data were collected between 2000 and 2023. RESULTS: In total, 1 808 584 patients were included in this study. In the derivation cohort, the 3 phenogroups had significantly different mortality profiles. After adjusting for known covariates, phenogroup B had a 20% increase in long-term mortality compared with phenogroup A (hazard ratio, 1.20 [95% CI, 1.17-1.23]; P<0.0001; phenogroup A mortality, 2.2%; phenogroup B mortality, 6.1%). In univariate analyses, we found phenogroup B had a significantly greater risk of mortality in all cohorts (log-rank P<0.01 in all 5 cohorts). Phenome-wide association study showed phenogroup B had a higher rate of future atrial fibrillation (odds ratio, 2.89; P<0.00001), ventricular tachycardia (odds ratio, 2.00; P<0.00001), ischemic heart disease (odds ratio, 1.44; P<0.00001), and cardiomyopathy (odds ratio, 2.04; P<0.00001). A single-trait genome-wide association study yielded 4 loci. SCN10A, SCN5A, and CAV1 have roles in cardiac conduction and arrhythmia. ARHGAP24 does not have a clear cardiac role and may be a novel target. CONCLUSIONS: Neural network-derived ECG features can be used to predict all-cause mortality and future cardiovascular diseases. We have identified biologically plausible and novel phenotypic and genotypic associations that describe mechanisms for the increased risk identified.
- MeSH
- časové faktory MeSH
- elektrokardiografie * MeSH
- fenotyp * MeSH
- hodnocení rizik MeSH
- kardiovaskulární nemoci diagnóza mortalita genetika patofyziologie MeSH
- lidé středního věku MeSH
- lidé MeSH
- neuronové sítě * MeSH
- prediktivní hodnota testů * MeSH
- prognóza MeSH
- reprodukovatelnost výsledků MeSH
- rizikové faktory MeSH
- senioři MeSH
- srdeční frekvence MeSH
- strojové učení bez učitele MeSH
- Check Tag
- lidé středního věku MeSH
- lidé MeSH
- mužské pohlaví MeSH
- senioři MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- multicentrická studie MeSH
- Geografické názvy
- Spojené státy americké MeSH
BACKGROUND: Heart transplantation (HTx) is an established therapeutic option for children with end-stage heart failure. Comprehensive pediatric nationwide HTx program was introduced in 2014 in the Czech Republic. The aim of this study was to evaluate its mid-term characteristics and outcomes and to compare them with international data. METHODS: Retrospective observational study, including all patients who underwent HTx from June 2014 till December 2022. Data from the institutional database were used for descriptive statistics and survival analyses. RESULTS: A total of 30 HTx were performed in 29 patients with congenital heart disease (CHD, N = 15, single ventricular physiology in 10 patients) and cardiomyopathy (CMP, N = 14). Ten patients were bridged to HTx by durable left ventricular assist devices (LVADs) for a mean duration of 104 (SD 89) days. There was one early and one late death during median follow-up of 3.3 (IQR 1.3-6.1) years. Survival probability at 5 years after HTx was 93%. Two patients underwent re-transplantation (one of them in an adult center). Significant rejection-free survival at 1, 3, and 6 years after HTx was 76%, 63%, and 63%, respectively. CONCLUSIONS: The introduced pediatric HTx program reflects the complexity of the treated population, with half of the patients having complex CHD and one-third being bridged to HTx by LVADs. Mid-term results are comparable to worldwide data. The data confirm the possibility of establishing a successful nationwide pediatric HTx program in a relatively small population country with well-developed pediatric cardiovascular care and other transplantation programs.
- MeSH
- dítě MeSH
- dospělí MeSH
- kardiomyopatie * MeSH
- lidé MeSH
- podpůrné srdeční systémy * MeSH
- retrospektivní studie MeSH
- srdeční selhání * chirurgie MeSH
- transplantace srdce * MeSH
- vrozené srdeční vady * MeSH
- výsledek terapie MeSH
- Check Tag
- dítě MeSH
- dospělí MeSH
- lidé MeSH
- Publikační typ
- časopisecké články MeSH
- pozorovací studie MeSH
- Geografické názvy
- Česká republika MeSH
BACKGROUND: Continuous deep septal pacing and signal recording during implantation of left bundle branch pacing (LBBP) lead enables to monitor beat-to-beat changes of electrocardiogram (ECG) and myocardial current of injury (COI) as the lead crosses the septum. OBJECTIVES: This study aimed to characterize patterns of continuous QRS, ST-T, and COI change for monitoring of the lead depth and instantaneous determination of the obtained capture type (LBBP vs left ventricular septal pacing [LVSP]). METHODS: The ECG and COI during lead implantation were scrutinized for sudden changes of V6 R-wave peak time, V1 initial and terminal R-wave amplitude, V3-V6 R-wave amplitude, repolarization pattern and S-wave amplitude in I, V5-V6, and COI drop. The sudden and gradual transition patterns were diagnosed depending on the presence or absence of the above beat-to-beat ECG phenomena, respectively. RESULTS: A total of 212 pacemaker recipients were analyzed; LBBP and LVSP were obtained in 77.4% and 22.6%, respectively. There were 4.7 ± 2.1 and 0.2 ± 0.6 beat-to-beat phenomena in LBBP and LVSP patients, respectively. The sudden transition pattern, recognized in 80.7%, had sensitivity and specificity for LBBP diagnosis of 98.8% and 81.2%, respectively. A sudden drop of COI (29.4 ± 8.5 mV to 12.8 ± 4.9 mV) was observed in 53.9% patients (LBBP was simultaneously obtained in 92.7%). CONCLUSIONS: Capture of left bundle branch during lead penetration is a beat-to-beat phenomenon. Two transseptal transition patterns were identified: 1) sudden, which is typical for obtaining LBBP; and 2) gradual, which is typical for obtaining LVSP. A sudden COI drop, a very observable phenomenon, also identified reaching the left subendocardial area.
- MeSH
- blokáda Tawarova raménka patofyziologie terapie MeSH
- elektrokardiografie * MeSH
- Hisův svazek patofyziologie MeSH
- kardiostimulace umělá metody MeSH
- kardiostimulátor MeSH
- lidé středního věku MeSH
- lidé MeSH
- senioři nad 80 let MeSH
- senioři MeSH
- srdeční septum patofyziologie MeSH
- Check Tag
- lidé středního věku MeSH
- lidé MeSH
- mužské pohlaví MeSH
- senioři nad 80 let MeSH
- senioři MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
OBJECTIVES: The use of ventricular assist devices (VADs) in children is increasing. However, absolute numbers in individual centres and countries remain small. Collaborative efforts such as the Paedi-European Registry for Patients with Mechanical Circulatory Support (EUROMACS) are therefore essential for combining international experience with paediatric VADs. Our goal was to present the results from the fourth Paedi-EUROMACS report. METHODS: All paediatric (<19 years) patients from the EUROMACS database supported by a VAD were included. Patients were stratified into a congenital heart disease (CHD) group and a group with a non-congenital aetiology. End points included mortality, a transplant and recovery. Cox proportional hazard models were used to explore associated factors for mortality, cerebrovascular accident and pump thrombosis. RESULTS: A total of 590 primary implants were included. The congenital group was significantly younger (2.5 vs 8.0 years, respectively, P < 0.001) and was more commonly supported by a pulsatile flow device (73.5% vs 59.9%, P < 0.001). Mortality was significantly higher in the congenital group (30.8% vs 20.4%, P = 0.009) than in the non-congenital group. However, in multivariable analyses, CHD was not significantly associated with mortality [hazard ratio (HR) 1.285; confidence interval (CI) 0.8111-2.036, P = 0.740]. Pump thrombosis was the most frequently reported adverse event (377 events in 132 patients; 0.925 events per patient-year) and was significantly associated with body surface area (HR 0.524, CI 0.333-0.823, P = 0.005), CHD (HR 1.641, CI 1.054-2.555, P = 0.028) and pulsatile flow support (HR 2.345, CI 1.406-3.910, P = 0.001) in multivariable analyses. CONCLUSIONS: This fourth Paedi-EUROMACS report highlights the increasing use of paediatric VADs. The patient populations with congenital and non-congenital aetiologies exhibit distinct characteristics and clinical outcomes.
- MeSH
- dítě MeSH
- kojenec MeSH
- lidé MeSH
- mladiství MeSH
- novorozenec MeSH
- podpůrné srdeční systémy * statistika a číselné údaje škodlivé účinky MeSH
- předškolní dítě MeSH
- registrace * statistika a číselné údaje MeSH
- srdeční selhání mortalita chirurgie MeSH
- vrozené srdeční vady chirurgie mortalita MeSH
- Check Tag
- dítě MeSH
- kojenec MeSH
- lidé MeSH
- mladiství MeSH
- mužské pohlaví MeSH
- novorozenec MeSH
- předškolní dítě MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- multicentrická studie MeSH
- Geografické názvy
- Evropa MeSH
BACKGROUND: The SafeBoosC project aims to test the clinical value of non-invasive cerebral oximetry by near-infrared spectroscopy in newborn infants. The purpose is to establish whether cerebral oximetry can be used to save newborn infants' lives and brains or not. Newborns contribute heavily to total childhood mortality and neonatal brain damage is the cause of a large part of handicaps such as cerebral palsy. The objective of the SafeBoosC-IIIv trial is to evaluate the benefits and harms of cerebral oximetry added to usual care versus usual care in mechanically ventilated newborns. METHODS/DESIGN: SafeBoosC-IIIv is an investigator-initiated, multinational, randomised, pragmatic phase-III clinical trial. The inclusion criteria will be newborns with a gestational age more than 28 + 0 weeks, postnatal age less than 28 days, predicted to require mechanical ventilation for at least 24 h, and prior informed consent from the parents or deferred consent or absence of opt-out. The exclusion criteria will be no available cerebral oximeter, suspicion of or confirmed brain injury or disorder, or congenital heart disease likely to require surgery. A total of 3000 participants will be randomised in 60 neonatal intensive care units from 16 countries, in a 1:1 allocation ratio to cerebral oximetry versus usual care. Participants in the cerebral oximetry group will undergo cerebral oximetry monitoring during mechanical ventilation in the neonatal intensive care unit for as long as deemed useful by the treating physician or until 28 days of life. The participants in the cerebral oximetry group will be treated according to the SafeBoosC treatment guideline. Participants in the usual care group will not receive cerebral oximetry and will receive usual care. We use two co-primary outcomes: (1) a composite of death from any cause or moderate to severe neurodevelopmental disability at 2 years of corrected age and (2) the non-verbal cognitive score of the Parent Report of Children's Abilities-Revised (PARCA-R) at 2 years of corrected age. DISCUSSION: There is need for a randomised clinical trial to evaluate cerebral oximetry added to usual care versus usual care in mechanically ventilated newborns. TRIAL REGISTRATION: The protocol is registered at www. CLINICALTRIALS: gov (NCT05907317; registered 18 June 2023).
- MeSH
- dítě MeSH
- jednotky intenzivní péče o novorozence MeSH
- kojenec MeSH
- lidé MeSH
- mozek MeSH
- mozkový krevní oběh MeSH
- novorozenec MeSH
- oxymetrie * metody MeSH
- randomizované kontrolované studie jako téma MeSH
- umělé dýchání * škodlivé účinky MeSH
- Check Tag
- dítě MeSH
- kojenec MeSH
- lidé MeSH
- novorozenec MeSH
- Publikační typ
- časopisecké články MeSH
- protokol klinické studie MeSH
Kontext: Závislost na kardiostimulátoru, kterou lze obecně definovat jako důsledek nedostatečného nebo chybějícího intrinsického pacientova srdečního rytmu, může mít nebezpečné následky při poruchách rytmu, jež mohou ovlivnit fungování kardiostimulátoru. Cíle: Zjistit prevalenci závislosti na kardiostimulátoru u pacientů s trvalým kardiostimulátorem a analyzovat jednotlivé faktory, které mohou vznik závislosti ovlivnit. Dělení pacientů na ty se závislostí versus bez závislosti na kardiostimulátoru významně ovlivňuje jejich léčbu. Pacienti a metoda: Do průřezové studie bylo zařazeno 400 pacientů s trvalým kardiostimulátorem pro různé bradyarytmické poruchy. Pacienti docházeli v rámci sledování od listopadu 2013 do srpna 2014 na specializované kardiochirurgické pracoviště Ibn Al-Bitar Specialized Center. Vyšetření případné závislosti na kardiostimulátoru se provádělo snížením základní stimulované frekvence na 30 tepů/min, přičemž se současně pozorně sledovala přítomnost intrinsického rytmu i rozvoj symptomů souvisejících s tzv. underpacingem. Všechny údaje potřebné pro náš výzkum se získávaly prostřednictvím dotazníku, programování a předchozích údajů o pacientovi. Závěr: Závislost na kardiostimulátoru byla zjištěna u 17 % zařazených pacientů. Nejvýznamnějšími proměnnými ovlivňujícími incidenci závislosti byly základní rytmus před implantací a celková doba stimulace. Demografické charakteristiky pacientů se závislostí na kardiostimulátoru nesouvisely. Nebyl ani prokázán žádný vztah mezi závislostí na kardiostimulátoru a způsobem stimulace, režimem frekvenčně reagující stimulace, případně dobou od implantace.
Background: Pacemaker dependency can be defined generally as inadequate or absent patient intrinsic rhythm, it has a dangerous consequence during conditions that may affect pacemaker function. Objectives: To identify the prevalence of pacemaker dependency among patients with permanent pacemaker and to analyze the particular factors that may affect its occurrence. Grouping the patients to pacemaker dependent or not has a great effect on patient management. Patients and method: A cross-sectional study enrolled 400 patients with permanent pacemaker for different bradyarrhythmia abnormalities. Patients visited Ibn Al-Bitar Specialized Center for cardiac surgery from November 2013 to August 2014 as a part of their follow up programming. The test for pacemaker dependency was performed by decreasing the base paced rate to 30 bpm with close observation to the presence of intrinsic rhythm as well as development of symptoms related to under pacing. All data needed for our research were obtained via questionnaire, programming, and patient previous data. Conclusion: Pacemaker dependency was identified in 17% of the enrolled patients. The underlying rhythm before implantation and the total time of pacing were the most important variables that affect the incidence of dependency. Patients' demographic characteristics were not associated with pacemaker dependency. Mode of pacing, rate adaptive mode, and time since pacemaker implantation were not found to be associated with pacemaker dependency.
OBJECTIVE: The onset of new conduction abnormalities requiring permanent pacemaker implantation (PPI) after transcatheter aortic valve implantation (TAVI) is still a relevant adverse event. The main objective of this registry was to identify modifiable procedural risk factors for an improved outcome (lower rate of PPI) after TAVI in patients at high risk of PPI. METHODS: Patients from four European centres receiving a balloon-expandable TAVI (Edwards SAPIEN 3/3 Ultra) and considered at high risk of PPI (pre-existing conduction disturbance, heavily calcified left ventricular outflow tract or short membranous septum) were prospectively enrolled into registry. RESULTS: A total of 300 patients were included: 42 (14.0%) required PPI after TAVI and 258 (86.0%) did not. Patients with PPI had a longer intensive care unit plus intermediate care stay (65.7 vs 16.3 hours, p<0.001), general ward care stay (6.9 vs 5.3 days, p=0.004) and later discharge (8.6 vs 5.0 days, p<0.001). Of the baseline variables, only pre-existing right bundle branch block at baseline (OR 6.8, 95% CI 2.5 to 18.1) was significantly associated with PPI in the multivariable analysis. Among procedure-related variables, oversizing had the highest impact on the rate of PPI: higher than manufacturer-recommended sizing, mean area oversizing as well as the use of the 29 mm valve (OR 3.4, 95% CI 1.4 to 8.5, p=0.008) all were significantly associated with PPI. Rates were higher with the SAPIEN 3 (16.1%) vs SAPIEN 3 Ultra (8.5%), although not statistically significant but potentially associated with valve sizing. Implantation depth and postdelivery balloon dilatation also tended to affect PPI rates but without a statistical significance. CONCLUSION: Valve oversizing is a strong procedure-related risk factor for PPI following TAVI. The clinical impact of the valve type (SAPIEN 3), implantation depth, and postdelivery balloon dilatation did not reach significance and may reflect already refined procedures in the participating centres, giving attention to these avoidable risk factors. TRIAL REGISTRATION NUMBER: NCT03497611.
- MeSH
- aortální stenóza * chirurgie MeSH
- kardiostimulace umělá škodlivé účinky metody MeSH
- kardiostimulátor * MeSH
- lidé MeSH
- registrace MeSH
- rizikové faktory MeSH
- srdeční chlopně umělé * škodlivé účinky MeSH
- transkatetrální implantace aortální chlopně * škodlivé účinky MeSH
- Check Tag
- lidé MeSH
- Publikační typ
- časopisecké články MeSH
- klinické zkoušky MeSH
- práce podpořená grantem MeSH