Electrical cardioversion presents one of the treatment options for atrial fibrillation (AF). However, the early recurrence rate is high, reaching ~40% three months after the procedure. Features based on vectorcardiographic signals were explored to find association with early recurrence of AF. Eighty-four patients with non-paroxysmal AF referred to electrical cardioversion were prospectively studied; early AF recurrence was present in 40 (47.6%). Patients underwent 24-h Holter ECG monitoring three months after the procedure to assess AF recurrence. Pre-procedural 12-lead ECGs (10 s, 1 kHz) were recorded and automatically analyzed. We explored associations of VCG-based features with early AF recurrence. Two features were strongly associated with AF recurrence: (1) a mean VCG (y-axis) signal slope in a window starting 145 ms before QRS center, lasting for 190 ms (AUC 0.778, p < 0.001), and (2) a mean VCG (z-axis) signal slope in a window starting 60 ms after QRS center, lasting for 465 ms (AUC 0.744, p < 0.001). These features showed higher association to the outcome than eighteen baseline clinical features. Our approach revealed features based on a slope of vectorcardiographic signals. This work also suggests that state of ventricles strongly affects the AF recurrence after electrical cardioversion.

• MeSH
• elektrická defibrilace * MeSH
• elektrokardiografie ambulantní MeSH
• fibrilace síní * terapie   patofyziologie   MeSH
• lidé středního věku MeSH
• lidé MeSH
• prospektivní studie MeSH
• recidiva * MeSH
• senioři MeSH
• vektorkardiografie * metody   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
• práce podpořená grantem MeSH

BACKGROUND: Inappropriate therapy (IAT) is an undesirable side effect of implantable cardiac defibrillator (ICD) therapy. Early studies with the subcutaneous ICD (S-ICD) showed relatively high inappropriate shock (IAS) rates. The PRAETORIAN (Prospective Randomized Comparison of Subcutaneous and Transvenous Implantable Cardioverter Defibrillator Therapy) trial demonstrated that the S-ICD is noninferior to the transvenous ICD (TV-ICD) with regard to the combined end point of IAS and complications. This secondary analyses evaluates all IAT in the PRAETORIAN trial. METHODS: This international, multicenter trial randomized 849 patients with an indication for ICD therapy between S-ICD (n=426) and TV-ICD therapy (n=423). ICD programming was mandated by protocol. All analysis were performed in the modified intention-to-treat population. RESULTS: In both groups 42 patients experienced IAT (48-month Kaplan-Meier estimated cumulative incidence, 9.9% and 10.1%, respectively; hazard ratio (HR), 0.99 [95% CI, 0.65-1.52]; P=0.97). There was no significant difference in patients experiencing IAS between both groups (P=0.14). In the S-ICD group, 81 IAT episodes with 124 IAS and 1 inappropriate antitachycardia pacing occurred versus 89 IAT episodes with 130 IAS and 124 inappropriate antitachycardia pacing in the TV-ICD group. IAT episodes were most frequently caused by supraventricular tachycardias in the TV-ICD group (n=83/89) versus cardiac oversensing in the S-ICD group (n=40/81). In the TV-ICD group, a baseline heart rate >80 bpm (HR, 1.99 [95% CI, 1.05-3.76]; P=0.03), a history of atrial fibrillation (HR, 2.66 [95% CI, 1.41-5.02]; P=0.003), and smoking (HR, 2.46 [95% CI, 1.31-4.09]; P=0.005) were independent predictors for IAT. A QRS duration >120 ms was an independent predictor for IAT caused by cardiac oversensing in the S-ICD group (HR, 3.13 [95% CI, 1.34-7.31]; P=0.008). Post-IAS interventions significantly reduced IAS recurrence in both groups (P=0.046). CONCLUSIONS: There was no significant difference in IAT and IAS rates between the S-ICD and TV-ICD in a conventional ICD population, but causes and predictors for IAT differed between the devices. After the first IAS, an intervention significantly reduced the recurrence rate of IAS. REGISTRATION: URL: https://www.clinicaltrials.gov; Unique identifier: NCT01296022.

• MeSH
• časové faktory MeSH
• defibrilátory implantabilní * MeSH
• elektrická defibrilace * přístrojové vybavení   škodlivé účinky   MeSH
• lidé středního věku MeSH
• lidé MeSH
• prospektivní studie MeSH
• rizikové faktory MeSH
• senioři 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
• multicentrická studie MeSH
• randomizované kontrolované studie MeSH
• srovnávací studie 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

• MeSH
• defibrilátory implantabilní * MeSH
• dítě MeSH
• elektrická defibrilace přístrojové vybavení   MeSH
• lidé MeSH
• mladiství MeSH
• náhlá srdeční smrt prevence a kontrola   MeSH
• věkové faktory MeSH
• Check Tag
• dítě MeSH
• lidé MeSH
• mladiství MeSH
• Publikační typ
• časopisecké články MeSH
• úvodníky MeSH

AIMS: Wearable cardioverter-defibrillators (WCDs) are indicated in patients at risk of sudden cardiac arrest who are not immediate candidates for implantable defibrillator therapy. Limitations of existing WCDs include poor compliance and high false alarm rates. The Jewel is a novel patch-WCD (P-WCD) that addresses these limitations with an adhesive-based design for near-continuous wear and a machine learning algorithm designed to minimize inappropriate detections. This was a first-in-human study of the Jewel P-WCD conducted in an electrophysiology (EP) lab to determine the safety and effectiveness of the device in terminating ventricular tachycardia/ventricular fibrillation (VT/VF) with a single shock. The aim was to evaluate the safety and effectiveness of terminating VT/VF with a single shock using the Jewel P-WCD. METHODS AND RESULTS: This was a first-in-human, prospective, single-arm, single-centre study in patients scheduled for an EP procedure in which VT/VF was expected to either spontaneously occur or be induced. The Jewel P-WCD was placed on consented patients; upon confirmation of VT/VF, a single shock (150 J) was delivered via the device. A group sequential design and Pocock alpha spending function was used to measure the observed proportion of successful VT/VF single-shock terminations. The endpoint was achieved if the lower confidence limit exceeded the performance goal of 62%, using a one-sided lower 97.4% exact confidence bound. Of 18 eligible subjects, 16 (88.9%, 97.4% confidence bound: 65.4%) were successfully defibrillated with a single shock, exceeding the primary endpoint performance goal with no adverse events. CONCLUSION: This first-in-human evaluation of the Jewel P-WCD demonstrated the safety and effectiveness of terminating VT/VF. CLINICAL TRIAL REGISTRATION: URL: https://clinicaltrials.gov/; Unique identifier: NCT05490459.

• MeSH
• defibrilátory * MeSH
• design vybavení MeSH
• dospělí MeSH
• elektrická defibrilace * přístrojové vybavení   škodlivé účinky   MeSH
• fibrilace komor * terapie   diagnóza   MeSH
• komorová tachykardie * terapie   diagnóza   patofyziologie   MeSH
• lidé středního věku MeSH
• lidé MeSH
• náhlá srdeční smrt prevence a kontrola   MeSH
• nositelná elektronika * MeSH
• prospektivní studie MeSH
• senioři 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

BACKGROUND: The optimal energy protocol for direct current cardioversion of atrial fibrillation remains uncertain. The Rational vs Maximum Fixed Energy (PROTOCOLENERGY) randomized trial compared a stepwise escalating energy algorithm (RaA, 150 J, 360 J, and 360 J) with a maximum fixed energy algorithm (MfA, 3 x 360 J). METHODS: In a 1:1 randomized trial, 300 patients with atrial fibrillation received biphasic discharges via hand-held paddles in the anterolateral position. Primary endpoints were sinus rhythm at 1 minute and neurologic complications at 2 hours; secondary endpoints included sinus rhythm at 2 hours, skin changes and chest discomfort at 24 hours. RESULTS: Sinus rhythm at 1 minute was achieved in 92.7% of RaA and 94.0% of MfA patients (P = 0.643) and maintained at 2 hours in 91.3% of both groups. There were no neurologic complications. The protocols differed significantly after the first shock (72.7% in RaA vs 83.3% in MfA; P = 0.026) but equalized after subsequent maximum energy shocks. Fewer RaA patients experienced skin redness compared with MfA patients (19.3% vs 36.0%, P = 0.001), which was attributed to the lower initial 150-J shock and total energy delivered (r = 0.243, P < 0.0001). Chest discomfort at 24 hours was not different between groups (P = 0.378). In multivariate analysis, lower body mass index (P < 0.001, cutoff 29 to 34 kg/m2) was associated with cardioversion success after the initial 150-J shock. CONCLUSIONS: Both protocols showed similar high cumulative efficacy, but RaA with the initial 150-J shock proved to be beneficial in patients with body mass index less than 29 to 34 kg/m2 because of fewer skin complications. CLINICAL TRIAL REGISTRATION NO: NCT05148923.

• MeSH
• algoritmy * MeSH
• elektrická defibrilace * metody   MeSH
• fibrilace síní * terapie   MeSH
• lidé středního věku MeSH
• lidé MeSH
• následné studie MeSH
• senioři 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
• randomizované kontrolované studie MeSH
• srovnávací studie MeSH

BACKGROUND: New methods to identify patients who benefit from a primary prophylactic implantable cardioverter-defibrillator (ICD) are needed. T-wave alternans (TWA) has been shown to associate with arrhythmogenesis of the heart and sudden cardiac death. We hypothesized that TWA might be associated with benefit from ICD implantation in primary prevention. METHODS AND RESULTS: In the EU-CERT-ICD (European Comparative Effectiveness Research to Assess the Use of Primary Prophylactic Implantable Cardioverter-Defibrillators) study, we prospectively enrolled 2327 candidates for primary prophylactic ICD. A 24-hour Holter monitor reading was taken from all recruited patients at enrollment. TWA was assessed from Holter monitoring using the modified moving average method. Study outcomes were all-cause death, appropriate shock, and survival benefit. TWA was assessed both as a contiguous variable and as a dichotomized variable with cutoff points <47 μV and <60 μV. The final cohort included 1734 valid T-wave alternans samples, 1211 patients with ICD, and 523 control patients with conservative treatment, with a mean follow-up time of 2.3 years. TWA ≥60 μV was a predicter for a higher all-cause death in patients with an ICD on the basis of a univariate Cox regression model (hazard ratio, 1.484 [95% CI, 1.024-2.151]; P=0.0374; concordance statistic, 0.51). In multivariable models, TWA was not prognostic of death or appropriate shocks in patients with an ICD. In addition, TWA was not prognostic of death in control patients. In a propensity score-adjusted Cox regression model, TWA was not a predictor of ICD benefit. CONCLUSIONS: T-wave alternans is poorly prognostic in patients with a primary prophylactic ICD. Although it may be prognostic of life-threatening arrhythmias and sudden cardiac death in several patient populations, it does not seem to be useful in assessing benefit from ICD therapy in primary prevention among patients with an ejection fraction of ≤35%.

• MeSH
• časové faktory MeSH
• defibrilátory implantabilní * MeSH
• elektrická defibrilace přístrojové vybavení   škodlivé účinky   MeSH
• elektrokardiografie ambulantní * metody   MeSH
• hodnocení rizik metody   MeSH
• lidé středního věku MeSH
• lidé MeSH
• náhlá srdeční smrt * prevence a kontrola   etiologie   MeSH
• prediktivní hodnota testů MeSH
• primární prevence * metody   MeSH
• prognóza MeSH
• prospektivní studie MeSH
• rizikové faktory MeSH
• senioři MeSH
• srdeční arytmie terapie   patofyziologie   diagnóza   prevence a kontrola   mortalita   MeSH
• srdeční frekvence fyziologie   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
• multicentrická studie MeSH
• Geografické názvy
• Evropa MeSH

PURPOSE: The echocardiography parameters may predict the maintenance of sinus rhythm after cardioversion of a supraventricular arrhythmia (SVA). MATERIALS AND METHODS: Patients in septic shock with onset of an SVA, normal to moderately reduced LV systolic function (EF_LV˃̳35%) and on a continuous noradrenaline of <1.0 μg/kg.min were included. Echocardiography was performed at the arrhythmia onset, 1 h and 4 h post cardioversion on an infusion of propafenone or amiodarone. RESULTS: Cardioversion was achieved in 96% of the 209 patients within a median time of 6(1.8-15.6)h, 134(64.1%) patients experienced at least one SVA recurrence after cardioversion. At 4 h the left atrial emptying fraction (LA_EF, cut-off 38.4%, AUC 0.69,p˂0.001), and transmitral A wave velocity-time-integral (Avti, cut-off 6.8 cm, AUC 0.65,p = 0.001) showed as limited predictors of a single arrhythmia recurrence. The LA_EF 44(36,49)%, (p = 0.005) and the Avti 8.65(7.13,9.50)cm, (p < 0.001) were associated with sustained sinus rhythm and decreased proportionally to increasing numbers of arrhythmia recurrences (p < 0.001 and p = 0.007, respectively). The enlarged left atrial end-systolic diameter at the arrhythmia onset (p = 0.04) and elevated systolic pulmonary artery pressure at 4 h (p = 0.007) were weak predictors of multiple(˃3) recurrences. CONCLUSION: The LA_EF and Avti are related to arrhythmia recurrences post-cardioversion suggesting potential guidance to the choice between rhythm and rate control strategies. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT03029169, registered on 24th of January 2017.

• MeSH
• amiodaron terapeutické užití   aplikace a dávkování   MeSH
• antiarytmika terapeutické užití   MeSH
• echokardiografie * MeSH
• elektrická defibrilace * MeSH
• lidé středního věku MeSH
• lidé MeSH
• propafenon terapeutické užití   aplikace a dávkování   MeSH
• prospektivní studie MeSH
• recidiva MeSH
• senioři MeSH
• septický šok * terapie   patofyziologie   komplikace   MeSH
• supraventrikulární tachykardie terapie   patofyziologie   diagnostické zobrazování   MeSH
• Check Tag
• lidé středního věku MeSH
• lidé MeSH
• mužské pohlaví MeSH
• senioři MeSH
• ženské pohlaví MeSH
• Publikační typ
• časopisecké články MeSH

BACKGROUND: Delayed hypothermia, initiated after hospital arrival, several hours after cardiac arrest with 8-10 hours to reach the target temperature, is likely to have limited impact on overall survival. However, the effect of ultrafast hypothermia, i.e., delivered intra-arrest or immediately after return of spontaneous circulation (ROSC), on functional neurologic outcome after out-of-hospital cardiac arrest (OHCA) is unclear. In two prior trials, prehospital trans-nasal evaporative intra-arrest cooling was safe, feasible and reduced time to target temperature compared to delayed cooling. Both studies showed trends towards improved neurologic recovery in patients with shockable rhythms. The aim of the PRINCESS2-study is to assess whether cooling, initiated either intra-arrest or immediately after ROSC, followed by in-hospital hypothermia, significantly increases survival with complete neurologic recovery as compared to standard normothermia care, in OHCA patients with shockable rhythms. METHODS/DESIGN: In this investigator-initiated, randomized, controlled trial, the emergency medical services (EMS) will randomize patients at the scene of cardiac arrest to either trans-nasal cooling within 20 minutes from EMS arrival with subsequent hypothermia at 33°C for 24 hours after hospital admission (intervention), or to standard of care with no prehospital or in-hospital cooling (control). Fever (>37,7°C) will be avoided for the first 72 hours in both groups. All patients will receive post resuscitation care and withdrawal of life support procedures according to current guidelines. Primary outcome is survival with complete neurologic recovery at 90 days, defined as modified Rankin scale (mRS) 0-1. Key secondary outcomes include survival to hospital discharge, survival at 90 days and mRS 0-3 at 90 days. In total, 1022 patients are required to detect an absolute difference of 9% (from 45 to 54%) in survival with neurologic recovery (80% power and one-sided α=0,025, β=0,2) and assuming 2,5% lost to follow-up. Recruitment starts in Q1 2024 and we expect maximum enrolment to be achieved during Q4 2024 at 20-25 European and US sites. DISCUSSION: This trial will assess the impact of ultrafast hypothermia applied on the scene of cardiac arrest, as compared to normothermia, on 90-day survival with complete neurologic recovery in OHCA patients with initial shockable rhythm. TRIAL REGISTRATION: NCT06025123.

• MeSH
• časové faktory MeSH
• elektrická defibrilace metody   MeSH
• kardiopulmonální resuscitace metody   MeSH
• lidé MeSH
• obnova funkce * MeSH
• obnovení spontánní cirukulace MeSH
• terapeutická hypotermie * metody   MeSH
• urgentní zdravotnické služby * metody   MeSH
• zástava srdce mimo nemocnici * terapie   mortalita   MeSH
• Check Tag
• lidé MeSH
• mužské pohlaví MeSH
• ženské pohlaví MeSH
• Publikační typ
• časopisecké články MeSH
• práce podpořená grantem MeSH
• protokol klinické studie MeSH
• randomizované kontrolované studie MeSH

• MeSH
• antiarytmika terapeutické užití   MeSH
• antikoagulancia terapeutické užití   MeSH
• beta blokátory terapeutické užití   MeSH
• diagnostické zobrazování metody   MeSH
• elektrická defibrilace metody   MeSH
• fibrilace síní * diagnóza   etiologie   terapie   MeSH
• flutter síní etiologie   MeSH
• katetrizační ablace metody   MeSH
• lidé MeSH
• srdeční resynchronizační terapie škodlivé účinky   MeSH
• srdeční selhání * komplikace   MeSH
• Check Tag
• lidé MeSH
• Publikační typ
• přehledy MeSH