This study sought to identify the incidence and outcome related to inappropriate implantable cardioverter-defibrillator (ICD) shocks, that is, those for nonventricular arrhythmias. BACKGROUND: The MADIT (Multicenter Automatic Defibrillator Implantation Trial) II showed that prophylactic ICD implantation improves survival in post-myocardial infarction patients with reduced ejection fraction. Inappropriate ICD shocks are common adverse consequences that may impair quality of life. METHODS: Stored ICD electrograms from all shock episodes were adjudicated centrally. An inappropriate shock episode was defined as an episode during which 1 or more inappropriate shocks occurred; another inappropriate ICD episode occurring within 5 min was not counted. Programmed parameters for patients with and without inappropriate shocks were compared. RESULTS: One or more inappropriate shocks occurred in 83 (11.5%) of the 719 MADIT II ICD patients. Inappropriate shock episodes constituted 184 of the 590 total shock episodes (31.2%). Smoking, prior atrial fibrillation, diastolic hypertension, and antecedent appropriate shock predicted inappropriate shock occurrence. Atrial fibrillation was the most common trigger for inappropriate shock (44%), followed by supraventricular tachycardia (36%), and then abnormal sensing (20%). The stability detection algorithm was programmed less frequently in patients receiving inappropriate shocks (17% vs. 36%, p = 0.030), whereas other programming parameters did not differ significantly from those without inappropriate shocks. Importantly, patients with inappropriate shocks had a greater likelihood of all-cause mortality in follow-up (hazard ratio 2.29, p = 0.025). CONCLUSIONS: Inappropriate ICD shocks occurred commonly in the MADIT II study, and were associated with increased risk of all-cause mortality.

• MeSH
• defibrilátory implantabilní škodlivé účinky   MeSH
• elektrická defibrilace mortalita   statistika a číselné údaje   škodlivé účinky   MeSH
• flutter síní mortalita   terapie   MeSH
• incidence MeSH
• infarkt myokardu komplikace   patofyziologie   MeSH
• klinické zkoušky jako téma MeSH
• lidé středního věku MeSH
• lidé MeSH
• odds ratio MeSH
• prospektivní studie MeSH
• retrospektivní studie MeSH
• rizikové faktory MeSH
• selhání zařízení MeSH
• supraventrikulární tachykardie mortalita   terapie   MeSH
• tepový objem MeSH
• Check Tag
• lidé středního věku MeSH
• lidé MeSH
• mužské pohlaví MeSH
• ženské pohlaví MeSH

BACKGROUND: The entirely subcutaneous implantable cardioverter-defibrillator (S-ICD) eliminates the need for transvenous leads, and therefore has the potential to improve lead-longevity and reduce lead-related complications. The S-ICD has a morphology-based sensing algorithm of which inappropriate shocks have been reported. METHODS: We analyzed the incidence, predictors and management of inappropriate shocks in the EFFORTLESS S-ICD Registry, which collects S-ICD implantation information and follow-up data from clinical centers in Europe and New Zealand. RESULTS: During a follow-up of 21 ± 13 months, 48 out of 581 S-ICD patients (71% male, age 49 ± 18 years) experienced 101 inappropriate shocks (8.3%). The most common cause was cardiac signal oversensing (73%), such as T-wave oversensing. Eighteen shocks (18%) were due to supraventricular tachycardias (SVT), of which 15 occurred in the shock-only zone. Cox-proportional hazard modeling using time-dependent covariates demonstrated that patients with a history of atrial fibrillation (HR 2.4) and patients with hypertrophic cardiomyopathy (HR 4.6) had an increased risk for inappropriate shocks, while programming the primary vector for sensing (from xyphoid to V6) reduced the risk. Reprogramming or optimization of SVT treatment after the first clinical event of inappropriate shock was successful in preventing further inappropriate shocks for cardiac oversensing and SVT events. CONCLUSIONS: Inappropriate shocks, mainly due to cardiac oversensing, occurred in 8.3% of the S-ICD patients. Patients with hypertrophic cardiomyopathy or a history of atrial fibrillation were at increased risk, warranting specific attention for sensing and programming in this population.

• MeSH
• analýza selhání vybavení statistika a číselné údaje   MeSH
• defibrilátory implantabilní * škodlivé účinky   normy   MeSH
• dospělí MeSH
• elektrická defibrilace * škodlivé účinky   metody   MeSH
• fibrilace síní epidemiologie   MeSH
• hypertrofická kardiomyopatie epidemiologie   MeSH
• incidence MeSH
• komorová tachykardie terapie   MeSH
• lidé středního věku MeSH
• lidé MeSH
• proporcionální rizikové modely MeSH
• rizikové faktory MeSH
• senioři MeSH
• standardní péče MeSH
• výsledek terapie MeSH
• zlepšení kvality MeSH
• Check Tag
• dospělí MeSH
• lidé středního věku MeSH
• lidé MeSH
• mužské pohlaví MeSH
• senioři MeSH
• ženské pohlaví MeSH
• Publikační typ
• časopisecké články MeSH
• klinické zkoušky MeSH
• multicentrická studie MeSH
• pozorovací studie MeSH
• práce podpořená grantem MeSH
• Geografické názvy
• Evropa MeSH
• Nový Zéland MeSH

Subcutaneous implantable cardioverter defibrillator (S-ICD) protects the patients at risk for sudden cardiac death while leaving the heart and vasculature untouched. It provides life-saving therapy, but may also deliver inappropriate therapy. Presented case demonstrates a possibility of S-ICD therapy induction due to double-counting. It was original caused by lack of suitable sensing vectors and the solution was possible just particularly. As the inter-individual variability of subcutaneous cardiac signal is considerable, the patient screening should be necessary for identification of such patients, which have an unsuitable subcutaneous sensing signals.

• MeSH
• defibrilátory implantabilní * MeSH
• elektrická defibrilace metody   MeSH
• elektrokardiografie metody   MeSH
• falešně pozitivní reakce MeSH
• lidé MeSH
• senioři MeSH
• výsledek terapie MeSH
• Check Tag
• lidé MeSH
• mužské pohlaví MeSH
• senioři MeSH
• Publikační typ
• kazuistiky MeSH

• MeSH
• adrenalin aplikace a dávkování   terapeutické užití   MeSH
• defibrilátory implantabilní * škodlivé účinky   MeSH
• dospělí MeSH
• fatální výsledek MeSH
• infarkt myokardu * MeSH
• kardiopulmonální resuscitace MeSH
• lidé MeSH
• transplantace srdce MeSH
• vazokonstriktory MeSH
• Check Tag
• dospělí MeSH
• lidé MeSH
• mužské pohlaví MeSH
• Publikační typ
• kazuistiky 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 benefit of novel implantable cardioverter defibrillator (ICD) programming in reducing inappropriate ICD therapy and mortality was demonstrated in Multicenter Automatic Defibrillator Implantation Trial-Reduce Inappropriate Therapy (MADIT-RIT). However, the cause of mortality reduction remains incompletely evaluated. We aimed to identify factors associated with mortality, with focus on ICD therapy and programming in the MADIT-RIT population. METHODS AND RESULTS: In MADIT-RIT, 1500 patients with a primary prophylactic indication for ICD or cardiac resynchronization therapy with defibrillator were randomized to 1 of 3 different ICD programming arms: conventional programming (ventricular tachycardia zone ≥170 beats per minute), high-rate programming (ventricular tachycardia zone ≥200 beats per minute), and delayed programming (60-second delay before therapy ≥170 beats per minute). Multivariate Cox models were used to assess the influence of time-dependent appropriate and inappropriate ICD therapy (shock and antitachycardia pacing) and randomized programming arm on all-cause mortality. During an average follow-up of 1.4±0.6 years, 71 of 1500 (5%) patients died: cardiac in 40 patients (56.3%), noncardiac in 23 patients (32.4%), and unknown in 8 patients (11.3%). Appropriate shocks (hazard ratio, 6.32; 95% confidence interval, 3.13-12.75; P<0.001) and inappropriate therapy (hazard ratio, 2.61; 95% confidence interval, 1.28-5.31; P=0.01) were significantly associated with an increased mortality risk. There was no evidence of increased mortality risk in patients who experienced appropriate antitachycardia pacing only (hazard ratio, 1.02; 95% confidence interval, 0.36-2.88; P=0.98). Randomization to conventional programming was identified as an independent predictor of death when compared with patients randomized to high-rate programming (hazard ratio, 2.0; 95% confidence interval, 1.06-3.71; P=0.03). CONCLUSIONS: In MADIT-RIT, appropriate shocks, inappropriate ICD therapy, and randomization to conventional ICD programming were independently associated with an increased mortality risk. Appropriate antitachycardia pacing was not related to an adverse outcome. CLINICAL TRIAL REGISTRATION URL: clinicaltrials.gov Unique identifier: NCT00947310.

• MeSH
• časové faktory MeSH
• defibrilátory implantabilní * MeSH
• elektrická defibrilace škodlivé účinky   přístrojové vybavení   mortalita   MeSH
• Kaplanův-Meierův odhad MeSH
• komorová tachykardie diagnóza   mortalita   patofyziologie   terapie   MeSH
• lidé středního věku MeSH
• lidé MeSH
• multivariační analýza MeSH
• proporcionální rizikové modely MeSH
• protézy - design * MeSH
• rizikové faktory MeSH
• rozdělení chí kvadrát MeSH
• selhání protézy * MeSH
• senioři nad 80 let MeSH
• senioři MeSH
• srdeční frekvence MeSH
• výsledek terapie MeSH
• Check Tag
• lidé středního věku MeSH
• lidé MeSH
• mužské pohlaví MeSH
• senioři nad 80 let MeSH
• senioři MeSH
• Publikační typ
• časopisecké články MeSH
• multicentrická studie MeSH
• práce podpořená grantem MeSH
• randomizované kontrolované studie MeSH
• Geografické názvy
• Evropa MeSH
• Izrael MeSH
• Japonsko MeSH
• Kanada MeSH
• Spojené státy americké MeSH

• MeSH
• anestezie MeSH
• arginin vasopresin * fyziologie   terapeutické užití   MeSH
• diabetes insipidus etiologie   farmakoterapie   MeSH
• péče o pacienty v kritickém stavu MeSH
• septický šok farmakoterapie   MeSH
• syndrom nepřiměřené sekrece ADH MeSH

• MeSH
• duševní poruchy MeSH
• hyponatremie MeSH
• osmotický tlak MeSH
• schizofrenie MeSH
• syndrom nepřiměřené sekrece ADH diagnóza   etiologie   komplikace   MeSH
• Publikační typ
• kongresy MeSH

Srdeční selhání je v současnosti onemocněním s obrovskými důsledky pro klinickou praxi i náklady na zdravotní péči. Léčba přístroji, jako jsou implantabilní kardioverter-defibrilátor (implantable cardioverter-defibrillator, ICD), se neustále vyvíjí a často dokáže zachránit život, v některých případech však pouze málo ovlivní symptomy. Optimální léčba často nedokáže zastavit progresi onemocnění; výsledkem je vznik arytmií (např. fibrilace síní), které by mohly být příčinou nežádoucích výbojů z ICD. Popisujeme případ pacienta s ICD, u něhož bylo provedeno kardiologické vyšetření na oddělení akutních příjmů pro opakované epizody dyspnoe a palpitací. V tomto případě byl zvolen konzervativní přístup s podáním kombinace sacubitril/valsartan spíše než použití jiných, invazivnějších metod, které by jinak bylo nutno v klinické praxi pro odstranění problému zkusit.

Heart failure (HF) is currently a condition with high impact both in terms of clinical practice and of health care costs. Therapy with cardiac devices such as implantable cardioverter-defibrillators (ICD) is constantly evolving and often it is life-saving. However, in some cases it has minimal clinical impact on the symptoms. An optimal therapy is often not sufficient to avoid progression of the pathology, leading to arrhythmias such as atrial fibrillation, which could cause inappropriate delivery of therapies from the ICD. We describe the case of a patient with ICD who underwent cardiac evaluation in the Emergency Department because he experienced multiple episodes of dyspnea and palpitations. In this case a conservative approach by administration of Sacubitril/Valsartan avoided other more invasive approaches that otherwise in clinical practice should be attempted to avoid inappropriate shocks.

• MeSH
• defibrilátory implantabilní MeSH
• echokardiografie MeSH
• fibrilace síní * farmakoterapie   MeSH
• kardiovaskulární látky aplikace a dávkování   MeSH
• lidé středního věku MeSH
• lidé MeSH
• srdeční selhání farmakoterapie   terapie   MeSH
• valsartan * terapeutické užití   MeSH
• výsledek terapie MeSH
• Check Tag
• lidé středního věku MeSH
• lidé MeSH
• mužské pohlaví MeSH
• Publikační typ
• kazuistiky MeSH

BACKGROUND: The PRAETORIAN trial (A Prospective, Randomized Comparison of Subcutaneous and Transvenous Implantable Cardioverter Defibrillator Therapy) showed noninferiority of subcutaneous implantable cardioverter defibrillator (S-ICD) compared with transvenous implantable cardioverter defibrillator (TV-ICD) with regard to inappropriate shocks and complications. In contrast to TV-ICD, S-ICD cannot provide antitachycardia pacing for monomorphic ventricular tachycardia. This prespecified secondary analysis evaluates appropriate therapy and whether antitachycardia pacing reduces the number of appropriate shocks. METHODS: The PRAETORIAN trial was an international, investigator-initiated randomized trial that included patients with an indication for implantable cardioverter defibrillator (ICD) therapy. Patients with previous ventricular tachycardia <170 bpm or refractory recurrent monomorphic ventricular tachycardia were excluded. In 39 centers, 849 patients were randomized to receive an S-ICD (n=426) or TV-ICD (n=423) and were followed for a median of 49.1 months. ICD programming was mandated by protocol. Appropriate ICD therapy was defined as therapy for ventricular arrhythmias. Arrhythmias were classified as discrete episodes and storm episodes (≥3 episodes within 24 hours). Analyses were performed in the modified intention-to-treat population. RESULTS: In the S-ICD group, 86 of 426 patients received appropriate therapy, versus 78 of 423 patients in the TV-ICD group, during a median follow-up of 52 months (48-month Kaplan-Meier estimates 19.4% and 17.5%; P=0.45). In the S-ICD group, 83 patients received at least 1 shock, versus 57 patients in the TV-ICD group (48-month Kaplan-Meier estimates 19.2% and 11.5%; P=0.02). Patients in the S-ICD group had a total of 254 shocks, compared with 228 shocks in the TV-ICD group (P=0.68). First shock efficacy was 93.8% in the S-ICD group and 91.6% in the TV-ICD group (P=0.40). The first antitachycardia pacing attempt successfully terminated 46% of all monomorphic ventricular tachycardias, but accelerated the arrhythmia in 9.4%. Ten patients with S-ICD experienced 13 electrical storms, versus 18 patients with TV-ICD with 19 electrical storms. Patients with appropriate therapy had an almost 2-fold increased relative risk of electrical storms in the TV-ICD group compared with the S-ICD group (P=0.05). CONCLUSIONS: In this trial, no difference was observed in shock efficacy of S-ICD compared with TV-ICD. Although patients in the S-ICD group were more likely to receive an ICD shock, the total number of appropriate shocks was not different between the 2 groups. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT01296022.

• MeSH
• defibrilátory implantabilní normy   MeSH
• lidé středního věku MeSH
• lidé MeSH
• prospektivní studie MeSH
• senioři MeSH
• srdeční arytmie diagnóza   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
• práce podpořená grantem MeSH
• randomizované kontrolované studie MeSH