This study investigates various microfluidic chip fabrication techniques, highlighting their applicability and limitations in the context of urgent diagnostic needs showcased by the COVID-19 pandemic. Through a detailed examination of methods such as computer numerical control milling of a polymethyl methacrylate, soft lithography for polydimethylsiloxane-based devices, xurography for glass-glass chips, and micromachining-based silicon-glass chips, we analyze each technique's strengths and trade-offs. Hence, we discuss the fabrication complexity and chip thermal properties, such as heating and cooling rates, which are essential features of chip utilization for a polymerase chain reaction. Our comparative analysis reveals critical insights into material challenges, design flexibility, and cost-efficiency, aiming to guide the development of robust and reliable microfluidic devices for healthcare and research. This work underscores the importance of selecting appropriate fabrication methods to optimize device functionality, durability, and production efficiency.
- MeSH
- COVID-19 * virologie MeSH
- design vybavení MeSH
- dimethylpolysiloxany chemie MeSH
- laboratoř na čipu * MeSH
- lidé MeSH
- mikrofluidika metody přístrojové vybavení MeSH
- mikrofluidní analytické techniky přístrojové vybavení metody MeSH
- polymethylmethakrylát chemie MeSH
- SARS-CoV-2 izolace a purifikace MeSH
- Check Tag
- lidé MeSH
- Publikační typ
- časopisecké články MeSH
- srovnávací studie MeSH
Leadless pacemakers (LPs) are self-contained pacemakers implanted inside the heart, providing a clinical strategy of pacing without pacemaker leads or a subcutaneous pocket. From an experimental therapy first used clinically in 2012, a decade later this technology is an established treatment option. Because of technologic advances and growing evidence, LPs are increasingly being used. Herein, the experience gained from a decade of leadless pacing is reviewed. We cover the safety and efficacy of single-chamber LPs, including comparisons with transvenous pacemakers and various models, and the initial clinical results of the first dual-chamber LP system. Furthermore, evidence and considerations regarding the optimal replacement strategy will be covered. Finally, we discuss future device developments that may broaden indications, such as LPs communicating with subcutaneous implantable cardiac defibrillators and energy-harvesting LPs.
- MeSH
- design vybavení * MeSH
- kardiostimulace umělá * metody trendy MeSH
- kardiostimulátor * trendy MeSH
- lidé MeSH
- srdeční arytmie terapie MeSH
- Check Tag
- lidé MeSH
- Publikační typ
- časopisecké články MeSH
- přehledy MeSH
BACKGROUND: The subcutaneous implantable cardioverter-defibrillator (S-ICD) was developed to overcome the risk of lead-related complications associated with the transvenous implantable cardioverter-defibrillator (TV-ICD). In contrast to the TV-ICD, the S-ICD is a completely extrathoracic device. Subsequently, complications differ between these 2 implantable cardioverter-defibrillators, which might impact patient perceptions of the therapies. This prespecified secondary analysis of the PRAETORIAN trial evaluates differences in quality of life. METHODS: The PRAETORIAN trial (A Prospective, Randomized Comparison of Subcutaneous and Transvenous Implantable Cardioverter Defibrillator Therapy) randomized patients with an implantable cardioverter-defibrillator indication, without the need for pacing to S-ICD or TV-ICD therapy. Two questionnaires were collected at baseline, discharge, 12 months, and 30 months. The Duke Activity Status Index measures cardiac-specific physical functioning, and the 36-Item Short Form Health Survey measures physical and mental well-being, with the subscales bodily pain and mental health being of interest in this analysis. Mann-Whitney U tests were used to compare study arms, and a mixed model was used to describe the questionnaire outcomes over time. RESULTS: Patients were randomized to S-ICD (n=426) and TV-ICD (n=423). In the S-ICD group, 20% were women versus 19% in the TV-ICD group. The median age was 63 (interquartile range, 54-69) years in the S-ICD group versus 64 (interquartile range, 56-69) years in the TV-ICD group. There were no significant differences in the Duke Activity Status Index and 36-Item Short Form Health Survey subscales for bodily pain and mental health between the groups at any time point. Patients with a shock in the last 90 days had significantly lower scores for social functioning (P=0.008) and role limitations due to emotional problems (P=0.001) than patients without a shock, but this effect did not differ between treatment arms. CONCLUSIONS: In a large randomized cohort of patients with an S-ICD or TV-ICD, no difference in overall quality of life was observed. However, implantable cardioverter-defibrillator shocks resulted in a reduction in quality of life, regardless of the device type or appropriateness. REGISTRATION: URL: https://www.clinicaltrials.gov; Unique identifier: NCT01296022.
- MeSH
- časové faktory MeSH
- defibrilátory implantabilní * MeSH
- duševní zdraví * MeSH
- elektrická defibrilace * přístrojové vybavení škodlivé účinky MeSH
- funkční status MeSH
- kvalita života * MeSH
- lidé středního věku MeSH
- lidé MeSH
- náhlá srdeční smrt prevence a kontrola MeSH
- prospektivní studie MeSH
- protézy - design MeSH
- průzkumy a dotazníky MeSH
- rizikové faktory MeSH
- senioři MeSH
- srdeční arytmie terapie diagnóza patofyziologie MeSH
- výsledek terapie MeSH
- zdravotní stav 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
- randomizované kontrolované studie MeSH
- srovnávací studie MeSH
AIMS: Catheter ablation is an effective treatment method for recurrent ventricular tachycardias (VTs). However, at least in part, procedural and clinical outcomes are limited by challenges in generating an adequate lesion size in the ventricular myocardium. We investigated procedural and clinical outcomes of VT ablation using a novel 'large-footprint' catheter that allows the creation of larger lesions either by radiofrequency (RF) or by pulsed field (PF) energy. METHODS AND RESULTS: In prospectively collected case series, we describe our initial experience with VT ablation using a lattice-tip, dual-energy catheter (Sphere-9, Medtronic), and a compatible proprietary electroanatomical mapping system (Affera, Medtronic). The study population consisted of 18 patients (aged 55 ± 15 years, one woman, structural heart disease: 94%, ischaemic heart disease: 56%, left ventricular ejection fraction: 34 ± 10%, electrical storm: 22%) with recurrent sustained VTs and ≥1 previously failed endocardial RF ablation with conventional irrigated-tip catheter in 66% of patients. On average, 12 ± 7 RF and 8 ± 9 PF applications were delivered per patient. In three-fourths of patients undergoing percutaneous epicardial ablation, spasms in coronary angiography were observed after PF applications. All resolved after intracoronary administration of nitrates. No acute phrenic nerve palsy was noted. One patient suffered from a stroke that resolved without sequelae. Post-ablation non-inducibility of VT was achieved in 89% of patients. Ventricular-arrhythmia-free survival at three months was 78%. CONCLUSION: VT ablation using a dual-energy lattice-tip catheter and a novel electroanatomical mapping system is feasible. It allows rapid mapping and effective substrate modification with good outcomes during short-term follow-up.
- MeSH
- akční potenciály MeSH
- časové faktory MeSH
- design vybavení MeSH
- doba přežití bez progrese choroby MeSH
- dospělí MeSH
- elektrofyziologické techniky kardiologické * MeSH
- katetrizační ablace * metody přístrojové vybavení škodlivé účinky MeSH
- komorová tachykardie * chirurgie patofyziologie diagnóza MeSH
- lidé středního věku MeSH
- lidé MeSH
- prospektivní studie MeSH
- recidiva MeSH
- senioři MeSH
- srdeční katétry * MeSH
- studie proveditelnosti * MeSH
- výsledek terapie MeSH
- Check Tag
- dospělí MeSH
- lidé středního věku MeSH
- lidé MeSH
- mužské pohlaví MeSH
- senioři MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
INTRODUCTION: Pulsed electric field (PEF) has emerged as a promising energy source for catheter ablation of atrial fibrillation (AF). However, data regarding the in-vivo effect of PEF energy on erythrocytes during AF ablation procedures are scarce. This study aimed to quantify the impact of PEF energy on erythrocyte damage during AF ablation by assessing specific hemolytic biomarkers. METHODS: A total of 60 patients (age: 68 years, males: 72%, serum creatinine: 91 μmol/L) with AF underwent catheter ablation of AF using PEF energy delivered by a multipolar pentaspline Farawave catheter (Farapulse, Boston Scientific, Inc.). Ablation beyond pulmonary vein isolation was performed at the operator's discretion. Peripheral venous blood was sampled for assessing the plasma levels of free hemoglobin (fHb), direct (conjugated) bilirubin, lactate dehydrogenase (LDH), and creatinine before, immediately after the ablation, and on the next day. RESULTS: Following the PEF ablation with duration of [median (interquartile range)] 75 (58, 95) min, with 74 (52, 92) applications and PVI only in 27% of patients, fHb, LDH, and direct bilirubin significantly increased, from 40 (18, 65) to 493 (327, 848) mg/L, from 3.1 (2.6, 3.6) to 6.8 (5.0, 7.9) μkat/L, and from 12 (9, 17) to 28 (16, 44) μmol/L, respectively (all p < .0001). A strong linear correlation was found between the peak fHb and the number of PEF applications (R = 0.81, p < .001). The major hemolysis (defined as fHb >500 mg/L) was predicted by the number of PEF applications with the corresponding area under the receiver operating characteristic curve of 0.934. The optimum cut-off value of >74 PEF applications predicted the major hemolysis with 89% sensitivity and 87% specificity. CONCLUSION: Catheter ablation of AF using PEF energy delivered from a pentaspline catheter is associated with significant intravascular hemolysis. More than 74 PEF applications frequently resulted in major hemolysis. However, the critical amount of PEF energy that may cause kidney injury in susceptible patients remains to be investigated.
- MeSH
- bilirubin krev MeSH
- biologické markery * krev MeSH
- časové faktory MeSH
- design vybavení MeSH
- erytrocyty MeSH
- fibrilace síní * chirurgie diagnóza patofyziologie krev MeSH
- hemoglobiny metabolismus MeSH
- hemolýza * MeSH
- katetrizační ablace * škodlivé účinky přístrojové vybavení MeSH
- kreatinin krev MeSH
- L-laktátdehydrogenasa krev MeSH
- lidé středního věku MeSH
- lidé MeSH
- prediktivní hodnota testů MeSH
- rizikové faktory MeSH
- senioři MeSH
- srdeční katétry MeSH
- výsledek terapie MeSH
- Check Tag
- lidé středního věku MeSH
- lidé MeSH
- mužské pohlaví MeSH
- senioři MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
AIMS: We report our single-centre experience of mid-term to long-term retrieval and reimplantation of a tine-based leadless pacemaker [Micra transcatheter pacing system (TPS)]. The TPS is a clinically effective alternative to transvenous single-chamber ventricular pacemakers. Whereas it is currently recommended to abandon the TPS at the end of device life, catheter-based retrieval may be favourable in specific scenarios. METHODS AND RESULTS: We report on nine consecutive patients with the implanted TPS who subsequently underwent transcatheter retrieval attempts. The retrieval system consists of the original TPS delivery catheter and an off-the-shelf single-loop 7 mm snare. The procedure was guided by fluoroscopy and intracardiac echocardiography. After an implantation duration of 3.1 ± 2.8 years (range 0.4-9.0), the overall retrieval success rate was 88.9% (8 of 9 patients). The mean procedure time was 89 ± 16 min, and the fluoroscopy time was 18.0 ± 6.6 min. No procedure-related adverse device events occurred. In the one unsuccessful retrieval, intracardiac echocardiography revealed that the TPS was partially embedded in the ventricular tissue surrounding the leadless pacemaker body in the right ventricle. After retrieval, three patients were reimplanted with a new TPS device. All implantations were successful without complications. CONCLUSION: A series of transvenous late retrievals of implanted TPS devices demonstrated safety and feasibility, followed by elective replacement with a new leadless pacing device or conventional transvenous pacing system. This provides a viable end-of-life management alternative to simple abandonment of this leadless pacemaker.
- MeSH
- časové faktory MeSH
- design vybavení MeSH
- echokardiografie MeSH
- intervenční radiografie MeSH
- kardiostimulace umělá metody MeSH
- kardiostimulátor * MeSH
- lidé středního věku MeSH
- lidé MeSH
- odstranění implantátu * metody MeSH
- senioři nad 80 let MeSH
- senioři MeSH
- srdeční katetrizace * metody přístrojové vybavení MeSH
- srdeční katétry MeSH
- výsledek terapie 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
In a pivotal trial (NCT05252702), the AVEIR DR (Abbott) leadless pacemaker system was found to be safe and effective in delivering DDDR synchronous atrial and ventricular pacing. This dual-chamber system employs 2 leadless pacemakers with implant-to-implant communication. Although implantation of the ventricular device as a single-chamber pacemaker has been well described, there are additional considerations surrounding the dual-chamber implantation procedure. Herein, we review the dual-chamber leadless pacemaker implantation workflow while providing guidance to optimize safe and effective implantation procedures.
- MeSH
- design vybavení * MeSH
- implantace protézy metody přístrojové vybavení MeSH
- kardiostimulace umělá metody MeSH
- kardiostimulátor * MeSH
- lidé MeSH
- Check Tag
- lidé MeSH
- Publikační typ
- časopisecké články MeSH
- přehledy MeSH
This study presents a graphene field-effect transistor (gFET) biosensor with dual detection capabilities for SARS-CoV-2: one RNA detection assay to confirm viral positivity and the other for nucleocapsid (N-)protein detection as a proxy for infectiousness of the patient. This technology can be rapidly adapted to emerging infectious diseases, making an essential tool to contain future pandemics. To detect viral RNA, the highly conserved E-gene of the virus was targeted, allowing for the determination of SARS-CoV-2 presence or absence using nasopharyngeal swab samples. For N-protein detection, specific antibodies were used. Tested on 213 clinical nasopharyngeal samples, the gFET biosensor showed good correlation with RT-PCR cycle threshold values, proving its high sensitivity in detecting SARS-CoV-2 RNA. Specificity was confirmed using 21 pre-pandemic samples positive for other respiratory viruses. The gFET biosensor had a limit of detection (LOD) for N-protein of 0.9 pM, establishing a foundation for the development of a sensitive tool for monitoring active viral infection. Results of gFET based N-protein detection corresponded to the results of virus culture in all 16 available clinical samples and thus it also proved its capability to serve as a proxy for infectivity. Overall, these findings support the potential of the gFET biosensor as a point-of-care device for rapid diagnosis of SARS-CoV-2 infection and indirect assessment of infectiousness in patients, providing additional information for clinical and public health decision-making.
- MeSH
- biosenzitivní techniky * přístrojové vybavení metody MeSH
- COVID-19 * diagnóza virologie MeSH
- design vybavení MeSH
- elektronické tranzistory MeSH
- fosfoproteiny MeSH
- grafit * chemie MeSH
- koronavirové nukleokapsidové proteiny izolace a purifikace MeSH
- lidé MeSH
- limita detekce MeSH
- nazofarynx virologie MeSH
- RNA virová * izolace a purifikace analýza MeSH
- SARS-CoV-2 * izolace a purifikace genetika MeSH
- Check Tag
- lidé MeSH
- Publikační typ
- časopisecké články MeSH
BACKGROUND: The i-gel® Plus is a modified version of the i-gel® supraglottic airway device. It contains a wider drainage port; a longer tip; ramps inside the breathing channel; and an additional port for oxygen delivery. There has been no prospective evaluation of this device in clinical practice. METHODS: This international, multicentre, prospective cohort study aimed to evaluate the performance of the i-gel Plus in adult patients undergoing elective procedures under general anaesthesia. The primary outcome was overall insertion success rate, defined as the ability to provide effective airway management through the device from insertion until the end of the surgical procedure. Secondary outcomes included device performance and incidence of postoperative adverse events. Data from the first 1000 patients are reported. RESULTS: In total, 1012 patients were enrolled; 12 forms were excluded from the final analysis due to incomplete data leaving 1000 included patients (545 female). Overall insertion success rate was 98.6%, with a first-attempt success rate of insertion of 88.2%. A significant difference between females and males was seen for the overall success rate (97.4% vs. 99.6% respectively) but not for first-attempt successful insertion. Mean (SD) oropharyngeal seal pressure was 32 (7) cmH2O. The only independent factor that increased the risk of first-attempt failure was low operator experience. Complications included desaturation < 85% in 0.6%; traces of blood on the device in 7.4%; laryngospasm in 0.5%; and gastric contents inside the bowl in 0.2% of patients. CONCLUSIONS: The i-gel Plus appears to be an effective supraglottic airway device that is associated with a high insertion success rate and a reasonably low incidence of complications.
- MeSH
- celková anestezie MeSH
- design vybavení MeSH
- dospělí MeSH
- elektivní chirurgické výkony * MeSH
- intratracheální intubace * přístrojové vybavení metody MeSH
- kohortové studie MeSH
- laryngální masky * MeSH
- lidé středního věku MeSH
- lidé MeSH
- pooperační komplikace epidemiologie MeSH
- prospektivní studie MeSH
- senioři MeSH
- zajištění dýchacích cest přístrojové vybavení metody MeSH
- Check Tag
- dospělí MeSH
- lidé středního věku MeSH
- lidé MeSH
- mužské pohlaví MeSH
- senioři MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- multicentrická studie MeSH
