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
BACKGROUND AND AIMS: Risk stratification of sudden cardiac death after myocardial infarction and prevention by defibrillator rely on left ventricular ejection fraction (LVEF). Improved risk stratification across the whole LVEF range is required for decision-making on defibrillator implantation. METHODS: The analysis pooled 20 data sets with 140 204 post-myocardial infarction patients containing information on demographics, medical history, clinical characteristics, biomarkers, electrocardiography, echocardiography, and cardiac magnetic resonance imaging. Separate analyses were performed in patients (i) carrying a primary prevention cardioverter-defibrillator with LVEF ≤ 35% [implantable cardioverter-defibrillator (ICD) patients], (ii) without cardioverter-defibrillator with LVEF ≤ 35% (non-ICD patients ≤ 35%), and (iii) without cardioverter-defibrillator with LVEF > 35% (non-ICD patients >35%). Primary outcome was sudden cardiac death or, in defibrillator carriers, appropriate defibrillator therapy. Using a competing risk framework and systematic internal-external cross-validation, a model using LVEF only, a multivariable flexible parametric survival model, and a multivariable random forest survival model were developed and externally validated. Predictive performance was assessed by random effect meta-analysis. RESULTS: There were 1326 primary outcomes in 7543 ICD patients, 1193 in 25 058 non-ICD patients ≤35%, and 1567 in 107 603 non-ICD patients >35% during mean follow-up of 30.0, 46.5, and 57.6 months, respectively. In these three subgroups, LVEF poorly predicted sudden cardiac death (c-statistics between 0.50 and 0.56). Considering additional parameters did not improve calibration and discrimination, and model generalizability was poor. CONCLUSIONS: More accurate risk stratification for sudden cardiac death and identification of low-risk individuals with severely reduced LVEF or of high-risk individuals with preserved LVEF was not feasible, neither using LVEF nor using other predictors.
- MeSH
- defibrilátory implantabilní * MeSH
- elektrokardiografie MeSH
- hodnocení rizik metody MeSH
- infarkt myokardu * mortalita komplikace MeSH
- lidé MeSH
- náhlá srdeční smrt * prevence a kontrola epidemiologie etiologie MeSH
- tepový objem * fyziologie MeSH
- Check Tag
- lidé MeSH
- Publikační typ
- časopisecké články MeSH
- metaanalýza MeSH
Hypertrofická kardiomyopatie je geneticky podmíněné onemocnění charakterizované zesílením stěn myokardu levé komory nad 15 mm při absenci jiné vysvětlující příčiny. Součástí diagnostiky a léčby pacientů s hypertrofickou kardiomyopatií je pátrání po obstrukci ve výtokovém traktu levé komory a její management, stratifikace rizika náhlé srdeční smrti, provedení genetického testování a screening rodinných pří- slušníků. Kazuistika popisuje případ mladého muže s chronickým dermatologickým onemocněním na trvalé biologické léčbě, s pozitivní rodinnou anamnézou náhlé srdeční smrti, u něhož byla nově diagnostikována hypertrofická kardiomyopatie se symptomatickou obstrukcí ve výtokovém traktu levé komory. U pacienta bylo indikováno provedení alkoholové septální ablace, která měla dobrý hemodynamický i klinický výsledek. V primární prevenci náhlé srdeční smrti mu byl implantován implantabilní kardioverter-defibrilátor, došlo však ke komplikaci v podobě časné infekce kapsy přístroje při pacientově kožním onemocnění a rozvoji reaktivní perikarditidy.
Hypertrophic cardiomyopathy is a genetic disorder characterized by increased left ventricle thickness greater than 15 milimetres in the absence of any other explanatory cause. The diagnostics and treatment of patients with hypertrophic cardiomyopathy include search for a management of left ventricular outflow tract obstruction, risk stratification for sudden cardiac death and genetic testing and screening of family members. This case report describes a young man with a chronic skin disease on permanent biological therapy who had a family history of sudden cardiac death and had recently been diagnosed with hypertrophic cardiomyopathy with symptomatic left ventricular outflow tract obstruction. An alcohol septal ablation had been indicated, resulting in improved hemodynamic and clinical outcome. An implantable cardioverter-defibrillator was implanted for the primary prevention of sudden cardiac death. However, an early device pocket infection due to the patient's skin disease and the development of reactive pericarditis led to complications.
- MeSH
- anamnéza MeSH
- defibrilátory implantabilní škodlivé účinky MeSH
- dospělí MeSH
- echokardiografie MeSH
- elektrokardiografie MeSH
- hemodynamické monitorování MeSH
- hidradenitis suppurativa * komplikace MeSH
- hypertrofická kardiomyopatie * diagnostické zobrazování genetika komplikace terapie MeSH
- lidé MeSH
- náhlá srdeční smrt prevence a kontrola MeSH
- perikarditida etiologie farmakoterapie MeSH
- Check Tag
- dospělí MeSH
- lidé MeSH
- mužské pohlaví MeSH
- Publikační typ
- kazuistiky MeSH
- MeSH
- defibrilátory implantabilní MeSH
- kardiologie MeSH
- kardiovaskulární nemoci * ošetřování MeSH
- lidé MeSH
- paliativní péče * MeSH
- Check Tag
- lidé MeSH
- Publikační typ
- přehledy MeSH
- MeSH
- defibrilátory implantabilní škodlivé účinky MeSH
- kardiochirurgické výkony MeSH
- kardiostimulace umělá * MeSH
- lidé MeSH
- pooperační komplikace MeSH
- Check Tag
- lidé MeSH
- Publikační typ
- přehledy 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
- MeSH
- antihypertenziva farmakologie terapeutické užití MeSH
- defibrilátory implantabilní MeSH
- hypertrofická kardiomyopatie * diagnóza genetika terapie MeSH
- kardiovaskulární nemoci etiologie MeSH
- lidé MeSH
- rizikové faktory kardiovaskulárních chorob MeSH
- svépomocné skupiny MeSH
- vzdělávání pacientů jako téma trendy MeSH
- Check Tag
- lidé MeSH
- Publikační typ
- novinové články MeSH
BACKGROUND AND AIMS: Arrhythmic mitral valve prolapse (AMVP) is linked to life-threatening ventricular arrhythmias (VAs), and young women are considered at high risk. Cases of AMVP in women with malignant VA during pregnancy have emerged, but the arrhythmic risk during pregnancy is unknown. The authors aimed to describe features of women with high-risk AMVP who developed malignant VA during the perinatal period and to assess if pregnancy and the postpartum period were associated with a higher risk of malignant VA. METHODS: This retrospective international multi-centre case series included high-risk women with AMVP who experienced malignant VA and at least one pregnancy. Malignant VA included ventricular fibrillation, sustained ventricular tachycardia, or appropriate shock from an implantable cardioverter defibrillator. The authors compared the incidence of malignant VA in non-pregnant periods and perinatal period; the latter defined as occurring during pregnancy and within 6 months after delivery. RESULTS: The authors included 18 women with AMVP from 11 centres. During 7.5 (interquartile range 5.8-16.6) years of follow-up, 37 malignant VAs occurred, of which 18 were pregnancy related occurring in 13 (72%) unique patients. Pregnancy and 6 months after delivery showed increased incidence rate of malignant VA compared to the non-pregnancy period (univariate incidence rate ratio 2.66, 95% confidence interval 1.23-5.76). CONCLUSIONS: The perinatal period could impose increased risk of malignant VA in women with high-risk AMVP. The data may provide general guidance for pre-conception counselling and for nuanced shared decision-making between patients and clinicians.
- MeSH
- defibrilátory implantabilní MeSH
- dospělí MeSH
- fibrilace komor epidemiologie etiologie MeSH
- incidence MeSH
- kardiovaskulární komplikace v těhotenství * epidemiologie MeSH
- komorová tachykardie epidemiologie etiologie MeSH
- lidé MeSH
- poporodní období MeSH
- poruchy v puerperiu epidemiologie etiologie MeSH
- prolaps mitrální chlopně * komplikace epidemiologie MeSH
- retrospektivní studie MeSH
- rizikové faktory MeSH
- srdeční arytmie epidemiologie etiologie MeSH
- těhotenství MeSH
- Check Tag
- dospělí MeSH
- lidé MeSH
- těhotenství MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- multicentrická studie MeSH
