OBJECTIVE: To investigate the clinical outcomes of patients who underwent cardioversion compared with those who did not have cardioverson in a large dataset of patients with recent onset non-valvular atrial fibrillation. DESIGN: Observational study using prospectively collected registry data (Global Anticoagulant Registry in the FIELD-AF-GARFIELD-AF). SETTING: 1317 participating sites in 35 countries. PARTICIPANTS: 52 057 patients aged 18 years and older with newly diagnosed atrial fibrillation (up to six weeks' duration) and at least one investigator determined stroke risk factor. MAIN OUTCOME MEASURES: Comparisons were made between patients who received cardioversion and those who had no cardioversion at baseline, and between patients who received direct current cardioversion and those who had pharmacological cardioversion. Overlap propensity weighting with Cox proportional hazards models was used to evaluate the effect of cardioversion on clinical endpoints (all cause mortality, non-haemorrhagic stroke or systemic embolism, and major bleeding), adjusting for baseline risk and patient selection. RESULTS: 44 201 patients were included in the analysis comparing cardioversion and no cardioversion, and of these, 6595 (14.9%) underwent cardioversion at baseline. The propensity score weighted hazard ratio for all cause mortality in the cardioversion group was 0.74 (95% confidence interval 0.63 to 0.86) from baseline to one year follow-up and 0.77 (0.64 to 0.93) from one year to two year follow-up. Of the 6595 patients who had cardioversion at baseline, 299 had a follow-up cardioversion more than 48 days after enrolment. 7175 patients were assessed in the analysis comparing type of cardioversion: 2427 (33.8%) received pharmacological cardioversion and 4748 (66.2%) had direct current cardioversion. During one year follow-up, event rates (per 100 patient years) for all cause mortality in patients who received direct current and pharmacological cardioversion were 1.36 (1.13 to 1.64) and 1.70 (1.35 to 2.14), respectively. CONCLUSION: In this large dataset of patients with recent onset non-valvular atrial fibrillation, a small proportion were treated with cardioversion. Direct current cardioversion was performed twice as often as pharmacological cardioversion, and there appeared to be no major difference in outcome events for these two cardioversion modalities. For the overall cardioversion group, after adjustments for confounders, a significantly lower risk of mortality was found in patients who received early cardioversion compared with those who did not receive early cardioversion. STUDY REGISTRATION: ClinicalTrials.gov NCT01090362.
- MeSH
- elektrická defibrilace metody mortalita MeSH
- fibrilace síní mortalita patologie terapie MeSH
- lidé středního věku MeSH
- lidé MeSH
- příčina smrti MeSH
- proporcionální rizikové modely MeSH
- prospektivní studie MeSH
- registrace MeSH
- senioři MeSH
- tendenční skóre MeSH
- 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
- pozorovací studie MeSH
Úvod: Fibrilace síní (FS) je celosvětově nejčastější formou arytmie, která postihuje přibližně 33 milionů jedinců. Antikoagulanciem volby v prevenci cévní mozkové příhody u jedinců s FS je již dlouho warfarin. Několik velkých studií prokázalo, že nová (přímá) perorální antikoagulancia (non-vitamin K antagonist oral anticoagulant, NOAC) mají z hlediska bezpečnosti a účinnosti řadu předností, jako například fixní dávku a předvídatelnější farmakokinetiku. Metody: Naše studie, provedená v lotyšském kardiocentru Fakultní nemocnice Pauls Stradins (Pauls Stradins Clinical University Hospital, Latvian Centre of Cardiology), probíhala od října 2015 do června 2017. Do studie bylo zařazeno celkem 356 pacientů, u nichž byla provedena elektrická kardioverze (EKV). Výsledky: Jeden rok po EKV užívalo 27,5 % pacientů warfarin, 33,7 % pacientů NOAC, zatímco 38,8 % jich neužívalo žádná perorální antikoagulancia. Devět (2,5 %) pacientů, kteří se studie zúčastnili, v následujícím roce zemřelo. Celkem u osmi pacientů (2,2 %) došlo k významnému krvácení a tři pacienti (0,8 %) prodělali nefatální ischemickou cévní mozkovou příhodu. Incidence nefatální ischemické cévní mozkové příhody u pacientů užívajících warfarin byla 2 %, přičemž u pacientů užívajících NOAC nebyla žádná taková příhoda zaznamenána (p = 0,20). Incidence významného krvácení byla 5,1 % versus 2,5 % ve skupinách s warfarinem, resp. NOAC (p = 0,12). Závěry: Ve srovnání s podobnými studiemi prokázala naše studie nízkou incidenci ischemických cévních mozkových příhod a významného krvácení i nízkou celkovou mortalitu. Jeden rok po EKV se užívání warfarinu snížilo o 2,8 % (p = 0,63) a v případě rivaroxabanu a dabigatranu o 17,5 % (p = 0,001), resp. 17,4 % (p = 0,001). Naše studie tak prokázala, že NOAC představují bezpečnou a účinnou alternativu k warfarinu. © 2021, ČKS.
Introduction: Atrial fibrillation (AF) is the most common arrhythmia in the world, affecting around 33 million people. Warfarin has been the anticoagulant of choice for the prevention of ischemic stroke in AF patients for a long time. Several large studies have shown that non-vitamin K antagonist oral anticoagulants (NOACs) offer numerous advantages regarding safety and effectiveness, such as fixed dose and more predictable pharmacokinetics. Methods: The study was conducted at Pauls Stradins Clinical University Hospital, Latvian Centre of Cardiology. The study took place from October 2015 to June 2017. A total of 356 patients who had undergone electrical cardioversion (ECV) was included in this study. Results: One year after ECV, 27.5% of patients used warfarin, 33.7% of patients used NOACs, whereas 38.8% did not use any oral anticoagulants. Nine (2.5%) of the patients who participated in the study died during the following year. Overall, eight patients (2.2%) suffered from significant bleeding and three patients (0.8%) had a non-fatal ischemic stroke. The rate of non-fatal ischemic stroke in patients who used warfarin was 2% and no cases were observed in patients who used NOACs (p = 0.20). The rate of significant bleeding was 5.1% versus 2.5% in warfarin and NOAC groups, respectively (p = 0.12). Conclusions: Compared with similar studies, our study showed a low rate of ischemic stroke and significant bleeding, and a low total death rate. One year after ECV, the use of warfarin decreased by 2.8% (p = 0.63), the use of rivaroxaban and dabigatran decreased by 17.5% (p = 0.001) and 17.4% (p = 0.001). The study shows that NOACs are a safe and effective alternative to warfarin.
- MeSH
- antikoagulancia * terapeutické užití MeSH
- aplikace orální MeSH
- cévní mozková příhoda epidemiologie prevence a kontrola MeSH
- dabigatran terapeutické užití MeSH
- elektrická defibrilace * mortalita statistika a číselné údaje MeSH
- fibrilace síní terapie MeSH
- krvácení epidemiologie MeSH
- lidé středního věku MeSH
- lidé MeSH
- průzkumy a dotazníky MeSH
- rivaroxaban terapeutické užití MeSH
- senioři MeSH
- statistika jako téma MeSH
- výsledek terapie MeSH
- warfarin terapeutické užití MeSH
- Check Tag
- lidé středního věku MeSH
- lidé MeSH
- mužské pohlaví MeSH
- senioři MeSH
- ženské pohlaví MeSH
- Publikační typ
- klinická studie MeSH
- Geografické názvy
- Lotyšsko MeSH
INTRODUCTION: Dual-coil leads (DC-leads) were the standard of choice since the first nonthoracotomy implantable cardioverter/defibrillator (ICD). We used contemporary data to determine if DC-leads offer any advantage over single-coil leads (SC-leads), in terms of defibrillation efficacy, safety, clinical outcome, and complication rates. METHODS AND RESULTS: In the Shockless IMPLant Evaluation study, 2500 patients received a first implanted ICD and were randomized to implantation with or without defibrillation testing. Two thousand and four hundred seventy-five patients received SC-coil or DC-coil leads (SC-leads in 1025/2475 patients; 41.4%). In patients who underwent defibrillation testing (n = 1204), patients with both lead types were equally likely to achieve an adequate defibrillation safety margin (88.8% vs 91.2%; P = 0.16). There was no overall effect of lead type on the primary study endpoint of "failed appropriate shock or arrhythmic death" (adjusted HR 1.18; 95% CI, 0.86-1.62; P = 0.300), and on all-cause mortality (SC-leads: 5.34%/year; DC-leads: 5.48%/year; adjusted HR 1.16; 95% CI, 0.94-1.43; P = 0.168). However, among patients without prior heart failure (HF), and SC-leads had a significantly higher risk of failed appropriate shock or arrhythmic death (adjusted HR 7.02; 95% CI, 2.41-20.5). There were no differences in complication rates. CONCLUSION: In this nonrandomized evaluation, there was no overall difference in defibrillation efficacy, safety, outcome, and complication rates between SC-leads and DC-leads. However, DC-leads were associated with a reduction in the composite of failed appropriate shock or arrhythmic death in the subgroup of non-HF patients. Considering riskier future lead extraction with DC-leads, SC-leads appears to be preferable in the majority of patients.
- MeSH
- časové faktory MeSH
- defibrilátory implantabilní * MeSH
- elektrická defibrilace škodlivé účinky přístrojové vybavení mortalita MeSH
- lidé středního věku MeSH
- lidé MeSH
- náhlá srdeční smrt prevence a kontrola MeSH
- příčina smrti MeSH
- primární prevence přístrojové vybavení MeSH
- protézy - design MeSH
- randomizované kontrolované studie jako téma MeSH
- rizikové faktory MeSH
- sekundární prevence přístrojové vybavení MeSH
- selhání protézy MeSH
- senioři MeSH
- srdeční arytmie diagnóza mortalita patofyziologie terapie 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
- pozorovací studie MeSH
- srovnávací studie MeSH
BACKGROUND: In the ICD Sports Safety Registry, death, arrhythmia- or shock-related physical injury did not occur in athletes who continue competitive sports after implantable cardioverter-defibrillator (ICD) implantation. However, data from non-competitive ICD recipients is lacking. This report describes arrhythmic events and lead performance in intensive recreational athletes with ICDs enrolled in the European recreational arm of the Registry, and compares their outcome with those of the competitive athletes in the Registry. METHODS: The Registry recruited 317 competitive athletes ≥ 18 years old, receiving an ICD for primary or secondary prevention (234 US; 83 non-US). In Europe, Israel and Australia only, an additional cohort of 80 'auto-competitive' recreational athletes was also included, engaged in intense physical activity on a regular basis (≥2×/week and/or ≥ 2 h/week) with the explicit aim to improve their physical performance limits. Athletes were followed for a median of 44 and 49 months, respectively. ICD shock data and clinical outcomes were adjudicated by three electrophysiologists. RESULTS: Compared with competitive athletes, recreational athletes were older (median 44 vs. 37 years; p = 0.0004), more frequently men (79% vs. 68%; p = 0.06), with less idiopathic ventricular fibrillation or catecholaminergic polymorphic ventricular tachycardia (1.3% vs. 15.4%), less congenital heart disease (1.3% vs. 6.9%) and more arrhythmogenic right ventricular cardiomyopathy (23.8% vs. 13.6%) ( p < 0.001). They more often had a prophylactic ICD implant (51.4% vs. 26.9%; p < 0.0001) or were given a beta-blocker (95% vs. 65%; p < 0.0001). Left ventricular ejection fraction, ICD rate cut-off and time from implant were similar. Recreational athletes performed fewer hours of sports per week (median 4.5 vs. 6 h; p = 0.0004) and fewer participated in sports with burst-performances ( vs. endurance) as their main sports: 4% vs. 65% ( p < 0.0001). None of the athletes in either group died, required external resuscitation or was injured due to arrhythmia or shock. Freedom from definite or probable lead malfunction was similar (5-year 97% vs. 96%; 10-year 93% vs. 91%). Recreational athletes received fewer total shocks (13.8% vs. 26.5%, p = 0.01) due to fewer inappropriate shocks (2.5% vs. 12%; p = 0.01). The proportion receiving appropriate shocks was similar (12.5% vs. 15.5%, p = 0.51). Recreational athletes received fewer total (6.3% vs. 20.2%; p = 0.003), appropriate (3.8% vs. 11.4%; p = 0.06) and inappropriate (2.5% vs. 9.5%; p = 0.04) shocks during physical activity. Ventricular tachycardia/fibrillation storms during physical activity occurred in 0/80 recreational vs. 7/317 competitive athletes. Appropriate shocks during physical activity were related to underlying disease ( p = 0.004) and competitive versus recreational sports ( p = 0.004), but there was no relation with age, gender, type of indication, beta-blocker use or burst/endurance sports. The proportion of athletes who stopped sports due to shocks was similar (3.8% vs. 7.5%, p = 0.32). CONCLUSIONS: Participants in recreational sports had less frequent appropriate and inappropriate shocks during physical activity than participants in competitive sports. Shocks did not cause death or injury. Recreational athletes with ICDs can engage in sports without severe adverse outcomes unless other reasons preclude continuation.
- MeSH
- defibrilátory implantabilní MeSH
- dospělí MeSH
- elektrická defibrilace * škodlivé účinky přístrojové vybavení mortalita MeSH
- hodnocení rizik MeSH
- kompetitivní chování MeSH
- lidé MeSH
- mladiství MeSH
- mladý dospělý MeSH
- náhlá srdeční smrt epidemiologie prevence a kontrola MeSH
- primární prevence MeSH
- prospektivní studie MeSH
- registrace MeSH
- rizikové faktory MeSH
- sekundární prevence MeSH
- sportovci * MeSH
- sporty * MeSH
- srdeční arytmie diagnóza mortalita patofyziologie terapie MeSH
- tělesná námaha * MeSH
- výsledek terapie MeSH
- Check Tag
- dospělí MeSH
- lidé MeSH
- mladiství MeSH
- mladý dospělý MeSH
- mužské pohlaví MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- multicentrická studie MeSH
- práce podpořená grantem MeSH
- srovnávací studie MeSH
- Geografické názvy
- Evropa MeSH
BACKGROUND: Although cardiac resynchronization therapy (CRT) is beneficial in heart failure patients with left bundle branch block, 30% of these patients do not respond to the therapy. Identifying these patients before implantation of the device is one of the current challenges in clinical cardiology. METHODS: We verified the diagnostic contribution and an optimized computerized approach to measuring ventricular electrical activation delay (VED) from body surface 12-lead ECGs. We applied the method to ECGs acquired before implantation (baseline) in the MADIT-CRT trial (Multicenter Automatic Defibrillator Implantation-Cardiac Resynchronization Therapy). VED values were dichotomized using its quartiles, and we tested the association of VED values with the MADIT-CRT primary end point of heart failure or death. Multivariate Cox proportional models were used to estimate the risk of study end points. In addition, the association between VED values and hemodynamic changes after CRT-D implantation was examined using 1-year follow-up echocardiograms. RESULTS: Our results showed that left bundle branch block patients with baseline VED <31.2 ms had a 35% risk of MADIT-CRT end points, whereas patients with VED ≥31.2 ms had a 14% risk (P<0.001). The hazard ratio for predicting primary end points in patients with low VED was 2.34 (95% confidence interval, 1.53-3.57; P<0.001). Higher VED values were also associated with beneficial hemodynamic changes. These strong VED associations were not found in the right bundle branch block and intraventricular conduction delay cohorts of the MADIT-CRT trial. CONCLUSIONS: Left bundle branch block patients with a high baseline VED value benefited most from CRT, whereas left bundle branch block patients with low VED did not show CRT benefits.
- MeSH
- akční potenciály * MeSH
- blokáda Tawarova raménka diagnóza mortalita patofyziologie terapie MeSH
- časové faktory MeSH
- defibrilátory implantabilní * MeSH
- elektrická defibrilace škodlivé účinky přístrojové vybavení mortalita MeSH
- elektrokardiografie * MeSH
- klinické rozhodování MeSH
- lidé středního věku MeSH
- lidé MeSH
- multicentrické studie jako téma MeSH
- obnova funkce MeSH
- prediktivní hodnota testů MeSH
- randomizované kontrolované studie jako téma MeSH
- retrospektivní studie MeSH
- senioři MeSH
- srdeční frekvence MeSH
- srdeční resynchronizační terapie * škodlivé účinky mortalita MeSH
- srdeční selhání diagnóza mortalita patofyziologie terapie MeSH
- výběr pacientů 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
Aims: Pocket haematoma is a common complication after defibrillator [implantable cardioverter defibrillator (ICD)] implantation, which is not only painful, but also increases the risk of device-related infection, and possibly embolic events. The present study seeks to evaluate the rate and predictors of clinically significant pocket haematoma. Methods and results: This study included 2500 patients receiving an ICD in the SIMPLE trial. A clinically significant pocket haematoma was defined as a haematoma that required re-operation or interruption of oral anticoagulation (OAC) therapy. Clinically significant pocket haematoma occurred in 56 of 2500 patients (2.2%) of which 6 (10.7%) developed device-related infection. Patients who developed pocket haematoma were older (mean age 67.6 ± 8.8 years vs. 62.7 ± 11.6 years, P < 0.001), were more likely to have permanent atrial fibrillation (30.4 vs. 6.7%, P < 0.001) and a history of stroke (17.9 vs. 6.7%, P = 0.004), or were more likely to receive peri-operative OAC (50.0 vs. 28.4%, P < 0.001), unfractionated heparin (16.1 vs. 5.2%, P = 0.003), or low-molecular-weight heparin (37.5 vs. 17.5%, P < 0.001). Independent predictors of wound haematoma on multivariable analysis included the use of heparin bridging (OR 2.65, 95% CI 1.48-4.73, P = 0.001), sub-pectoral location of ICD (OR 2.00, 95% CI 1.12-3.57, P =0.020), previous stroke (OR 2.47, 95% CI 1.20-5.10, P = 0.015), an upgrade from permanent pacemaker (OR 2.52, 95% CI 1.07-5.94, P = 0.035), and older age (OR 1.03, 95% CI 1.00-1.06, P = 0.049). Conclusion: Pocket haematoma remains an important complication of ICD implantation and is associated with a high risk of infection. Independent predictors of pocket haematoma include heparin bridging, prior stroke, sub-pectoral placement of ICD, older age, and upgrade from a pacemaker.
- MeSH
- chirurgická rána diagnóza epidemiologie MeSH
- defibrilátory implantabilní * škodlivé účinky MeSH
- elektrická defibrilace škodlivé účinky přístrojové vybavení mortalita MeSH
- hematom diagnóza epidemiologie MeSH
- heparin aplikace a dávkování škodlivé účinky MeSH
- implantace protézy škodlivé účinky přístrojové vybavení mortalita MeSH
- incidence MeSH
- infekce spojené s protézou epidemiologie MeSH
- lidé středního věku MeSH
- lidé MeSH
- logistické modely MeSH
- multivariační analýza MeSH
- nelineární dynamika MeSH
- odds ratio MeSH
- prospektivní studie MeSH
- rizikové faktory MeSH
- rozdělení chí kvadrát MeSH
- senioři MeSH
- srdeční arytmie diagnóza mortalita terapie MeSH
- věkové faktory 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
INTRODUCTION: We aim to compare the acute and long-term success of defibrillation between non-apical and apical ICD lead position. METHODS AND RESULTS: The position of the ventricular lead was recorded by the implanting physician for 2,475 of 2,500 subjects in the Shockless IMPLant Evaluation (SIMPLE) trial, and subjects were grouped accordingly as non-apical or apical. The success of intra-operative defibrillation testing and of subsequent clinical shocks were compared. Propensity scoring was used to adjust for the impact of differences in baseline variables between these groups. There were 541 leads that were implanted at a non-apical position (21.9%). Patients implanted with a non-apical lead had a higher rate of secondary prevention indication. Non-apical location resulted in a lower mean R-wave amplitude (14.0 vs. 15.2, P < 0.001), lower mean pacing impedance (662 ohm vs. 728 ohm, P < 0.001), and higher mean pacing threshold (0.70 V vs. 0.66 V, P = 0.01). Single-coil leads and cardiac resynchronization devices were used more often in non-apical implants. The success of intra-operative defibrillation was similar between propensity score matched groups (89%). Over a mean follow-up of 3 years, there were no significant differences in the yearly rates of appropriate shock (5.5% vs. 5.4%, P = 0.98), failed appropriate first shock (0.9% vs. 1.0%, P = 0.66), or the composite of failed shock or arrhythmic death (2.8% vs. 2.3% P = 0.35) according to lead location. CONCLUSION: We did not detect any reduction in the ICD efficacy at the time of implant or during follow-up in patients receiving a non-apical RV lead.
- MeSH
- časové faktory MeSH
- defibrilátory implantabilní * MeSH
- elektrická defibrilace škodlivé účinky přístrojové vybavení metody mortalita MeSH
- elektrofyziologické techniky kardiologické MeSH
- Kaplanův-Meierův odhad MeSH
- kardiostimulace umělá MeSH
- lidé středního věku MeSH
- lidé MeSH
- logistické modely MeSH
- náhlá srdeční smrt etiologie MeSH
- proporcionální rizikové modely MeSH
- prospektivní studie MeSH
- protézy - design MeSH
- rizikové faktory MeSH
- selhání protézy MeSH
- senioři MeSH
- srdeční arytmie komplikace diagnóza mortalita terapie MeSH
- tendenční skóre 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
- práce podpořená grantem MeSH
- randomizované kontrolované studie MeSH
- srovnávací studie MeSH
BACKGROUND: Defibrillation testing by induction and termination of ventricular fibrillation is widely done at the time of implantation of implantable cardioverter defibrillators (ICDs). We aimed to compare the efficacy and safety of ICD implantation without defibrillation testing versus the standard of ICD implantation with defibrillation testing. METHODS: In this single-blind, randomised, multicentre, non-inferiority trial (Shockless IMPLant Evaluation [SIMPLE]), we recruited patients aged older than 18 years receiving their first ICD for standard indications at 85 hospitals in 18 countries worldwide. Exclusion criteria included pregnancy, awaiting transplantation, particpation in another randomised trial, unavailability for follow-up, or if it was expected that the ICD would have to be implanted on the right-hand side of the chest. Patients undergoing initial implantation of a Boston Scientific ICD were randomly assigned (1:1) using a computer-generated sequence to have either defibrillation testing (testing group) or not (no-testing group). We used random block sizes to conceal treatment allocation from the patients, and randomisation was stratified by clinical centre. Our primary efficacy analysis tested the intention-to-treat population for non-inferiority of no-testing versus testing by use of a composite outcome of arrhythmic death or failed appropriate shock (ie, a shock that did not terminate a spontaneous episode of ventricular tachycardia or fibrillation). The non-inferiority margin was a hazard ratio (HR) of 1·5 calculated from a proportional hazards model with no-testing versus testing as the only covariate; if the upper bound of the 95% CI was less than 1·5, we concluded that ICD insertion without testing was non-inferior to ICD with testing. We examined safety with two, 30 day, adverse event outcome clusters. The trial is registered with ClinicalTrials.gov, number NCT00800384. FINDINGS: Between Jan 13, 2009, and April 4, 2011, of 2500 eligible patients, 1253 were randomly assigned to defibrillation testing and 1247 to no-testing, and followed up for a mean of 3·1 years (SD 1·0). The primary outcome of arrhythmic death or failed appropriate shock occurred in fewer patients (90 [7% per year]) in the no-testing group than patients who did receive it (104 [8% per year]; HR 0·86, 95% CI 0·65-1·14; pnon-inferiority <0·0001). The first safety composite outcome occurred in 69 (5·6%) of 1236 patients with no-testing and in 81 (6·5%) of 1242 patients with defibrillation testing, p=0·33. The second, pre-specified safety composite outcome, which included only events most likely to be directly caused by testing, occurred in 3·2% of patients with no-testing and in 4·5% with defibrillation testing, p=0·08. Heart failure needing intravenous treatment with inotropes or diuretics was the most common adverse event (in 20 [2%] of 1236 patients in the no-testing group vs 28 [2%] of 1242 patients in the testing group, p=0·25). INTERPRETATION: Routine defibrillation testing at the time of ICD implantation is generally well tolerated, but does not improve shock efficacy or reduce arrhythmic death. FUNDING: Boston Scientific and the Heart and Stroke Foundation (Ontario Provincial office).
- MeSH
- bezpečnost pacientů MeSH
- defibrilátory implantabilní * MeSH
- elektrická defibrilace metody mortalita MeSH
- fibrilace komor etiologie MeSH
- hodnocení rizik MeSH
- implantace protézy metody mortalita MeSH
- jednoduchá slepá metoda MeSH
- lidé středního věku MeSH
- lidé MeSH
- pooperační komplikace etiologie mortalita MeSH
- prognóza MeSH
- srdeční arytmie mortalita terapie MeSH
- srdeční selhání etiologie MeSH
- Check Tag
- lidé středního věku MeSH
- lidé MeSH
- mužské pohlaví MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- multicentrická studie MeSH
- práce podpořená grantem MeSH
- randomizované kontrolované studie MeSH
- srovnávací studie MeSH
BACKGROUND: Because the final myocardial scar might be theoretically associated with an increased risk of sudden cardiac death, the long-term clinical course of patients who undergo alcohol septal ablation (ASA) is still a matter of debate. In this retrospective multicentre study, we report outcomes after ASA, including survival, analysis of causes of deaths, and association between time and cause of death. METHODS: We enrolled 366 consecutive patients (58 ± 12 years, 54% women) who were treated using ASA and followed-up for 5.1 ± 4.5 years. RESULTS: The in-hospital and 30-day mortality were 0.5% and 0.8%, respectively; the ASA-related morbidity was < 20%. Overall, 52 patients died during 1867 patient-years, which means the all-cause mortality rate was 2.8% per year. The mortality rates of sudden death and sudden death with an appropriate implantable cardioverter-defibrillator (ICD) discharge were 0.4% and 1% per year, respectively. Patients with sudden death or appropriate ICD discharge experienced these mortality events at younger age than patients who died of other hypertrophic obstructive cardiomyopathy-related causes (60.8 years [range, 52-71.5 years] vs 72.4 years [range, 64.2-75.2 years]; P = 0.048). A total of 292 patients (80%) had an outflow gradient ≤ 30 mm Hg, and 327 patients (89%) were in New York Heart Association class ≤ II at the last clinical check-up. CONCLUSIONS: ASA had low procedure-related mortality, with subsequent 1% occurrence of sudden mortality events per year and 2.8% mortality rate per year in the long-term follow-up. Patients with sudden death or ICD discharge experienced the mortality events approximately 1 decade earlier than patients who died from other causes not related to hypertrophic cardiomyopathy.
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- alkoholy terapeutické užití MeSH
- analýza přežití MeSH
- časové faktory MeSH
- defibrilátory implantabilní MeSH
- elektrická defibrilace metody mortalita MeSH
- hypertrofická kardiomyopatie * diagnóza mortalita chirurgie MeSH
- jizva * etiologie mortalita patologie MeSH
- katetrizační ablace * škodlivé účinky metody mortalita MeSH
- lidé středního věku MeSH
- lidé MeSH
- mortalita v nemocnicích MeSH
- myokard patologie MeSH
- náhlá srdeční smrt etiologie prevence a kontrola MeSH
- následné studie MeSH
- příčina smrti MeSH
- senioři MeSH
- sklerotizující roztoky terapeutické užití 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
- Geografické názvy
- Česká republika MeSH
- Polsko MeSH
- Rakousko MeSH
INTRODUCTION: The MADIT-RIT trial demonstrated reduction of inappropriate and appropriate ICD therapies and mortality by high-rate cut-off and 60-second-delayed VT therapy ICD programming in patients with a primary prophylactic ICD indication. The aim of this analysis was to study effects of MADIT-RIT ICD programming in patients with ischemic and nonischemic cardiomyopathy. METHODS AND RESULTS: First and total occurrences of both inappropriate and appropriate ICD therapies were analyzed by multivariate Cox models in 791 (53%) patients with ischemic and 707 (47%) patients with nonischemic cardiomyopathy. Patients with ischemic and nonischemic cardiomyopathy had similar incidence of first inappropriate (9% and 11%, P = 0.21) and first appropriate ICD therapy (11.6% and 14.1%, P = 0.15). Patients with ischemic cardiomyopathy had higher mortality rate (6.1% vs. 3.3%, P = 0.01). MADIT-RIT high-rate cut-off (arm B) and delayed VT therapy ICD programming (arm C) compared with conventional (arm A) ICD programming were associated with a significant risk reduction of first inappropriate and appropriate ICD therapy in patients with ischemic and nonischemic cardiomyopathy (HR range 0.11-0.34, P < 0.001 for all comparisons). Occurrence of total inappropriate and appropriate ICD therapies was significantly reduced by high-rate cut-off ICD programming and delayed VT therapy ICD programming in both ischemic and nonischemic cardiomyopathy patients. CONCLUSION: High-rate cut-off and delayed VT therapy ICD programming are associated with significant reduction in first and total inappropriate and appropriate ICD therapy in patients with ischemic and nonischemic cardiomyopathy.
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- časové faktory MeSH
- defibrilátory implantabilní * MeSH
- design vybavení MeSH
- elektrická defibrilace škodlivé účinky přístrojové vybavení mortalita MeSH
- elektrofyziologické techniky kardiologické MeSH
- ischemická choroba srdeční komplikace diagnóza mortalita MeSH
- Kaplanův-Meierův odhad MeSH
- kardiomyopatie diagnóza etiologie mortalita patofyziologie MeSH
- komorová tachykardie diagnóza etiologie mortalita patofyziologie terapie MeSH
- lidé středního věku MeSH
- lidé MeSH
- multivariační analýza MeSH
- náhlá srdeční smrt etiologie prevence a kontrola MeSH
- počítačové zpracování signálu MeSH
- prediktivní hodnota testů MeSH
- proporcionální rizikové modely MeSH
- rizikové faktory MeSH
- rozdělení chí kvadrát MeSH
- selhání zařízení * 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
- práce podpořená grantem MeSH
- randomizované kontrolované studie MeSH
- Geografické názvy
- Evropa MeSH
- Izrael MeSH
- Spojené státy americké MeSH