BACKGROUND: Veno-arterial extracorporeal membrane oxygenation (VA-ECMO) is increasingly being used for circulatory support in patients with cardiogenic shock, although the evidence supporting its use in this context remains insufficient. The ECMO-CS trial (Extracorporeal Membrane Oxygenation in the Therapy of Cardiogenic Shock) aimed to compare immediate implementation of VA-ECMO versus an initially conservative therapy (allowing downstream use of VA-ECMO) in patients with rapidly deteriorating or severe cardiogenic shock. METHODS: This multicenter, randomized, investigator-initiated, academic clinical trial included patients with either rapidly deteriorating or severe cardiogenic shock. Patients were randomly assigned to immediate VA-ECMO or no immediate VA-ECMO. Other diagnostic and therapeutic procedures were performed as per current standards of care. In the early conservative group, VA-ECMO could be used downstream in case of worsening hemodynamic status. The primary end point was the composite of death from any cause, resuscitated circulatory arrest, and implementation of another mechanical circulatory support device at 30 days. RESULTS: A total of 122 patients were randomized; after excluding 5 patients because of the absence of informed consent, 117 subjects were included in the analysis, of whom 58 were randomized to immediate VA-ECMO and 59 to no immediate VA-ECMO. The composite primary end point occurred in 37 (63.8%) and 42 (71.2%) patients in the immediate VA-ECMO and the no early VA-ECMO groups, respectively (hazard ratio, 0.72 [95% CI, 0.46-1.12]; P=0.21). VA-ECMO was used in 23 (39%) of no early VA-ECMO patients. The 30-day incidence of resuscitated cardiac arrest (10.3.% versus 13.6%; risk difference, -3.2 [95% CI, -15.0 to 8.5]), all-cause mortality (50.0% versus 47.5%; risk difference, 2.5 [95% CI, -15.6 to 20.7]), serious adverse events (60.3% versus 61.0%; risk difference, -0.7 [95% CI, -18.4 to 17.0]), sepsis, pneumonia, stroke, leg ischemia, and bleeding was not statistically different between the immediate VA-ECMO and the no immediate VA-ECMO groups. CONCLUSIONS: Immediate implementation of VA-ECMO in patients with rapidly deteriorating or severe cardiogenic shock did not improve clinical outcomes compared with an early conservative strategy that permitted downstream use of VA-ECMO in case of worsening hemodynamic status. REGISTRATION: URL: https://www. CLINICALTRIALS: gov; Unique identifier: NCT02301819.
- MeSH
- hemodynamika MeSH
- kardiogenní šok diagnóza terapie MeSH
- lidé MeSH
- mimotělní membránová oxygenace * metody MeSH
- mortalita v nemocnicích MeSH
- retrospektivní studie MeSH
- srdeční zástava * MeSH
- Check Tag
- lidé MeSH
- Publikační typ
- časopisecké články MeSH
- multicentrická studie MeSH
- práce podpořená grantem MeSH
- randomizované kontrolované studie MeSH
BACKGROUND: The subcutaneous implantable cardioverter-defibrillator (S-ICD) has demonstrated safety and efficacy for the treatment of malignant ventricular arrhythmias. However, a limitation of the S-ICD lies in the inability to either pace-terminate ventricular tachycardia or provide prolonged bradycardia pacing support. OBJECTIVE: The rationale and design of a prospective, single-arm, multinational trial of an intercommunicative leadless pacing system integrated with the S-ICD will be presented. METHODS: A technical description of the modular cardiac rhythm management (mCRM) system (EMPOWER leadless pacemaker and EMBLEM S-ICD) and the implantation procedure is provided. MODULAR ATP (Effectiveness of the EMPOWERTM Modular Pacing System and EMBLEMTM Subcutaneous ICD to Communicate Antitachycardia Pacing) is a multicenter, international trial enrolling up to 300 patients at risk of sudden cardiac death at up to 60 centers trial design. The safety endpoint of freedom from major complications related to the mCRM system or implantation procedure at 6 months and 2 years are significantly higher than 86% and 81%, respectively, and all-cause survival is significantly >85% at 2 years. RESULTS: Efficacy endpoints are that at 6 months mCRM communication success is significantly higher than 88% and the percentage of subjects with low and stable thresholds is significantly higher than 80%. Substudies to evaluate rate-responsive features and performance of the pacing module are also described. CONCLUSION: The MODULAR ATP global clinical trial will prospectively test the safety and efficacy of the first intercommunicating leadless pacing system with the S-ICD. This trial will allow for robust validation of device-device communication, pacing performance, rate responsiveness, and system safety.
- Publikační typ
- časopisecké články MeSH
BACKGROUND: The inspIRE study (Study for Treatment of Paroxysmal Atrial Fibrillation [PAF] by Pulsed Field Ablation [PFA] System With Irreversible Electroporation [IRE]) evaluated safety and effectiveness of a fully integrated biphasic pulsed field ablation (PFA) system with a variable-loop circular catheter for the treatment of drug-refractory paroxysmal atrial fibrillation. METHODS: Subjects underwent pulmonary vein (PV) isolation with the PFA system, using at least 12 applications per vein; adenosine/isoproterenol was administered to confirm entrance block. Wave I assessed initial safety, including for esophageal lesions, silent cerebral lesions, and PV stenosis. Wave II (pivotal phase) tested (1) primary safety, incidence of early-onset primary adverse events, and (2) primary effectiveness, confirmed PV isolation with freedom from documented atrial arrhythmia at 12 months. The study design specified an interim analysis to determine early success once 30 subjects reached the 12-month follow-up and all subjects reached 3-month follow-up. RESULTS: Across 13 centers in Europe/Canada, 226 subjects were enrolled, met criteria for safety and effectiveness evaluations, and received PFA (Wave I, 40; Wave II, 186). Wave I demonstrated no esophageal thermal lesions or PV stenosis. Among 39 subjects with cerebral magnetic resonance imaging, silent cerebral lesions were detected in 4 of the first 6 subjects, after which workflow enhancements, including a 10-second pause between PFA applications, were implemented; subsequently, only 4 of 33 subjects had silent cerebral lesions. In the Wave II phase, no primary adverse events were reported. Upon declaring early success, 83 subjects reached 12-month follow-up. With 100% entrance block, PV isolation without acute reconnection was achieved in 97.1% of targeted veins. For Wave II, the primary effectiveness end point per Kaplan-Meier at the time of interim analysis was 70.9%; 12-month freedom from symptomatic atrial fibrillation/atrial flutter/atrial tachycardia recurrence and repeat ablation was 78.9% and 92.3%, respectively. Total procedure and transpired PFA times were 70.1±27.7 and 26.7±14.0 minutes, respectively. CONCLUSIONS: The inspIRE trial confirmed the safety and effectiveness of the novel mapping-integrated PFA system. REGISTRATION: URL: https://www. CLINICALTRIALS: gov; unique identifier: NCT04524364.
- MeSH
- fibrilace síní * diagnóza chirurgie etiologie MeSH
- katetrizační ablace * škodlivé účinky metody MeSH
- katétry MeSH
- lidé MeSH
- recidiva MeSH
- stenóza plicní žíly * etiologie MeSH
- stenóza etiologie chirurgie MeSH
- venae pulmonales * chirurgie MeSH
- výsledek terapie MeSH
- Check Tag
- lidé MeSH
- Publikační typ
- časopisecké články MeSH
- multicentrická studie MeSH
- Geografické názvy
- Evropa MeSH
INTRODUCTION: Cardiopulmonary resuscitation (CPR)-related injuries have not been assessed since the 2015 Resuscitation Guidelines were established. AIM: To describe the incidence and severity of CPR-related injuries, and to evaluate the impact of the 2015 European Resuscitation Council (ERC) guidelines on the objective assessment of injuries. METHODS: This multicenter, retrospective study analyzed autopsy reports of patients who underwent CPR. The most severe injuries were objectively assessed using the Abbreviated Injury Scale (AIS) and all injuries were summarized according to the New Injury Severity Score (NISS). RESULTS: Among 628 autopsy reports analyzed, patient characteristics and case details were distributed as follows: male sex, 71.1%; median age, 67 years; out-of-hospital cardiac arrest, 89.2%; bystander CPR, 56.8%. CPR-related injuries included: rib(s) 94.6%; lung(s), 9.9%; sternum, 62.4%; liver, 2.5%; and spleen, 1.8%. The incidence of bystander-provided CPR and severity of injury were similar to CPR provided only by professionals. There were no difference between mechanical and manual compressions. Females were older (p = 0.0001) and, although the frequency of their injuries was similar to males, they were significantly more severe (p = 0.01). Patients with life-threatening injury exhibited a baseline profile similar to those without injury . The median score (according to AIS) of the most severe injury was 3 and the median of summary of injuries was 13 according to the NISS-low risk of fatal injury. CONCLUSION: CPR-related injuries occurred frequently, although those that were life-threatening accounted for only 3% of cases. There were no differences between patients who were resuscitated by bystander(s) or by professionals and no differences between mechanical chest devices or manual resuscitation. Compared with a study based on the 2010 guidelines, similar injuries were found, but with more rib fractures, less visceral organ damage, and fewer life-threatening injuries.
- MeSH
- fraktury žeber * epidemiologie etiologie MeSH
- kardiopulmonální resuscitace * škodlivé účinky MeSH
- lidé MeSH
- pitva MeSH
- retrospektivní studie MeSH
- senioři MeSH
- zástava srdce mimo nemocnici * epidemiologie terapie komplikace MeSH
- Check Tag
- lidé MeSH
- mužské pohlaví MeSH
- senioři MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- multicentrická studie MeSH
Background In prior unblinded studies, cardiac neuromodulation therapy (CNT) employing a sequence of variably timed short and longer atrioventricular intervals yielded sustained reductions of systolic blood pressure (SBP) in patients with hypertension. The effects of CNT on SBP were investigated in this double-blind randomized pilot study. Methods and Results Eligible patients had daytime ambulatory SBP (aSBP) ≥130 mm Hg and office SBP ≥140 mm Hg despite taking ≥1 antihypertensive medication, and an indication for a dual-chamber pacemaker. Patients underwent Moderato device implantation, which was programmed as a standard pacemaker during a 1-month run-in phase. Patients whose daytime aSBP was ≥125 mm Hg at the end of this period were randomized (1:1, double blind) to treatment (CNT) or control (CNT inactive). The primary efficacy end point was the between-group difference of the change in 24-hour aSBP at 6 months. Of 68 patients initially enrolled and who underwent implantation with the Moderato system, 47 met criteria for study continuation and were randomized (26 treatment, 21 control). The mean age was 74.0±8.7 years, 64% were men, left ventricular ejection fraction was 59.2%±5.7%, and aSBP averaged 141.0±10.8 mm Hg despite the use of 3.3±1.5 antihypertensive medications; 81% had isolated systolic hypertension. Six months after randomization, aSBP was 11.1±10.5 mm Hg (95% CI, -15.2 to -8.1 mm Hg) lower than prerandomization in the treatment group compared with 3.1±9.5 mm Hg (-7.4 to 1.2 mm Hg) lower in controls, yielding a net treatment effect of 8.1±10.1 mm Hg (-14.2 to -1.9 mm Hg) (P=0.012). There were no Moderato device- or CNT-related adverse events. Conclusions CNT significantly reduced 24-hour aSBP in patients with hypertension with a clinical indication for a pacemaker. The majority of patients had isolated systolic hypertension, a particularly difficult group of patients to treat. Registration URL: https://www.clinicaltrials.gov; Unique identifier: NCT02837445.
- MeSH
- časové faktory MeSH
- dvojitá slepá metoda MeSH
- funkce levé komory srdeční MeSH
- hypertenze diagnóza patofyziologie terapie MeSH
- kardiostimulace umělá * škodlivé účinky MeSH
- kardiostimulátor * MeSH
- krevní tlak * MeSH
- lidé MeSH
- pilotní projekty MeSH
- prospektivní studie MeSH
- senioři nad 80 let MeSH
- senioři MeSH
- srdce inervace MeSH
- srdeční frekvence * MeSH
- výsledek terapie MeSH
- Check Tag
- lidé MeSH
- mužské pohlaví MeSH
- senioři nad 80 let MeSH
- senioři MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- multicentrická studie MeSH
- práce podpořená grantem MeSH
- randomizované kontrolované studie MeSH
- Geografické názvy
- Evropa MeSH
INTRODUCTION: Thermally induced cardiac lesions result in necrosis, edema, and inflammation. This tissue change may be seen with ultrasound. In this study, we sought to use intracardiac echocardiography (ICE) to evaluate pulmonary vein tissue morphology and assess the acute tissue changes that occur following radiofrequency (RF) or laser ablation for atrial fibrillation (AF). METHODS AND RESULTS: Patients with AF underwent pulmonary vein isolation (PVI) using irrigated RF or laser balloon. Pre- and post-ablation ICE imaging was performed from within each pulmonary vein (PV). At least 10 transverse imaging planes per PV were evaluated and each plane was divided into eight segments. The PV/atrial wall thickness and the luminal area were measured at each segment. Twenty-seven patients underwent PVI (15 with laser, 12 with RF). Ninety-eight pulmonary veins were analyzed (58 PVs laser; 40 PVs RF). At baseline, there were no regional differences in PV wall thickness in the right-sided veins. The anterior regions of left superior pulmonary vein (LSPV) and left inferior pulmonary vein (LIPV) were significantly thicker compared with the posterior and inferior regions (p < .01). Post-ablation, PV wall thickness in RF group increased 24.1% interquartile range (IQR) (17.2%-36.7%) compared with 1.2% IQR (0.4%-8.9%) in laser group, p = .004. In all PVs, RF ablation resulted in significantly greater percent increase in wall thickness compared with laser. Additionally, RF resulted in more variable changes in regional PV wall thickness; with more increases in wall thickness in anterior versus posterior LSPV (75.4 ± 58.5% vs. 46.8 ± 55.6%, p < .01), anterior versus posterior right superior pulmonary vein (RSPV) (62.9 ± 63.9% vs. 44.6 ± 51.7%, p < .05), and superior versus inferior RSPV (69.1 ± 45.4% vs. 35.9 ± 45%, p < .05). There were no significant regional differences in PV wall thickness changes for the laser group. CONCLUSIONS: Rotational ICE can be used to measure acute tissue changes with ablation. Regional variability in baseline wall thickness was nonuniformly present in PVs. Acute tissue changes occurred immediately post-ablation. Compared with laser balloon, RF shows markedly more thickening post-ablation with significant regional variations.
INTRODUCTION: When cardiac magnetic resonance (MR) is performed after previous leadless transcatheter pacemaker implantation, an image distortion has to be expected in the heart region and evaluation of myocardial tissue can be affected. In this clinical prospective study, we aim to assess the extent and impact of this artifact on individual ventricular segments and compare it to conventional pacing devices. METHODS: Total of 20 patients with leadless pacemaker placed in the right ventricle underwent cardiac MR imaging in a 1.5 Tesla scanner. A multiplanar segmentation was used to demarcate the left and right ventricular myocardium as well as the pacemaker-caused image artifact in systolic and diastolic time frames. Artifact size and its relative influence on myocardial segments were quantitatively assessed and expressed in AHA-17 model. RESULTS: Implanted leadless pacemaker caused an image artifact with a volume of 48 ± 5 ml. Most distorted were the apical septal (53 ± 23%), apical inferior (30 ± 18%), and midventricular inferoseptal (30 ± 20%) segments. The artifact intersection with basal and lateral segments was none or negligible (up to 2%). The portion of left ventricular (LV) myocardium affected by the artifact was significantly higher in systole (8 ± 4%) compared to diastole (10 ± 3%; p < .001). CONCLUSION: Implantation of leadless pacemaker represents no obstacle for cardiac MR imaging but causes an image artifact located mostly in septal, inferoseptal, and anteroseptal segments of apical and midventricular LV myocardium. With the exception of the apex, diastolic timing reduces the image distortion of all segments and improves global ventricular assessment.
- MeSH
- artefakty * MeSH
- kardiostimulátor * MeSH
- lidé MeSH
- magnetická rezonanční spektroskopie MeSH
- prospektivní studie MeSH
- srdce MeSH
- Check Tag
- lidé MeSH
- Publikační typ
- časopisecké články MeSH
- práce podpořená grantem MeSH
Transcatheter therapies to treat tricuspid regurgitation are being developed, but few have attempted the gold standard of surgical repair: ring annuloplasty. We describe the first-ever fully percutaneous implantation of a circumferential, semirigid annuloplasty ring to treat massive secondary tricuspid regurgitation. (Level of Difficulty: Advanced.).
- Publikační typ
- kazuistiky MeSH
Extracorporeal life support (ECLS) is a treatment modality that provides prolonged blood circulation, gas exchange and can partially support or fully substitute functions of heart and lungs in patients with severe but potentially reversible cardiopulmonary failure refractory to conventional therapy. Due to high-volume bypass, the extracorporeal flow is interacting with native cardiac output. The pathophysiology of circulation and ECLS support reveals significant effects on arterial pressure waveforms, cardiac hemodynamics, and myocardial perfusion. Moreover, it is still subject of research, whether increasing stroke work caused by the extracorporeal flow is accompanied by adequate myocardial oxygen supply. The left ventricular (LV) pressure-volume mechanics are reflecting perfusion and loading conditions and these changes are dependent on the degree of the extracorporeal blood flow. By increasing the afterload, artificial circulation puts higher demands on heart work with increasing myocardial oxygen consumption. Further, this can lead to LV distention, pulmonary edema, and progression of heart failure. Multiple methods of LV decompression (atrial septostomy, active venting, intra-aortic balloon pump, pulsatility of flow) have been suggested to relieve LV overload but the main risk factors still remain unclear. In this context, it has been recommended to keep the rate of circulatory support as low as possible. Also, utilization of detailed hemodynamic monitoring has been suggested in order to avoid possible harm from excessive extracorporeal flow.
Veno-arterial extracorporeal membrane oxygenation (VA ECMO) is a technique used in patients with severe heart failure. The aim of this study was to evaluate its effects on left ventricular afterload and fluid accumulation in lungs with electrical impedance tomography (EIT). In eight swine, incremental increases of extracorporeal blood flow (EBF) were applied before and after the induction of ischemic heart failure. Hemodynamic parameters were continuously recorded and computational analysis of EIT was used to determine lung fluid accumulation. With an increase in EBF from 1 to 4 l/min in acute heart failure the associated increase of arterial pressure (raised by 44%) was accompanied with significant decrease of electrical impedance of lung regions. Increasing EBF in healthy circulation did not cause lung impedance changes. Our findings indicate that in severe heart failure EIT may reflect fluid accumulation in lungs due to increasing EBF.
- MeSH
- elektrická impedance MeSH
- hemodynamika MeSH
- koronární cirkulace fyziologie MeSH
- mimotělní membránová oxygenace škodlivé účinky metody MeSH
- modely nemocí na zvířatech MeSH
- plíce patofyziologie MeSH
- prasata MeSH
- respirační insuficience etiologie patologie MeSH
- srdeční selhání metabolismus patologie terapie MeSH
- zvířata MeSH
- Check Tag
- ženské pohlaví MeSH
- zvířata MeSH
- Publikační typ
- časopisecké články MeSH
