This study investigated whether defibrillation threshold (DFT) testing during implantable cardioverter-defibrillator (ICD) implantation predicts clinical outcomes. BACKGROUND: Defibrillation testing is often performed during insertion of ICDs to confirm shock efficacy. There are no prospective data to suggest that this procedure improves outcomes when modern ICDs are implanted for primary prevention of sudden death. METHODS: The analysis included the 811 patients who were randomized to the ICD arm of the SCD-HeFT (Sudden Cardiac Death in Heart Failure Trial) and had the device implanted. The DFT testing protocol in SCD-HeFT was designed to limit shock testing in a primary prevention heart failure population. RESULTS: Baseline DFT data were available for 717 patients (88.4%). All 717 patients had a DFT of < or =30 J, the maximum output of the device in this study. The DFT was < or =20 J in 97.8% of patients. There was no survival difference between patients with a lower DFT (< or =10 J, n = 547) and a higher DFT (>10 J, n = 170) (p = 0.41). First shock efficacy was 83.0% for the first clinical ventricular tachyarrhythmia event; there were no differences in shock efficacies when the cohort was subdivided by baseline DFT. CONCLUSIONS: Low baseline DFTs were obtained in patients with stable, optimally treated heart failure during ICD implantation for primary prevention of sudden death. First shock efficacy for ventricular tachyarrhythmias was high regardless of baseline DFT testing results. Baseline DFT testing did not predict long-term mortality or shock efficacy in this study.

• MeSH
• amiodaron terapeutické užití   MeSH
• antiarytmika terapeutické užití   MeSH
• defibrilátory implantabilní MeSH
• diferenční práh MeSH
• elektrofyziologické techniky kardiologické MeSH
• fibrilace komor komplikace   prevence a kontrola   MeSH
• lidé MeSH
• náhlá srdeční smrt etiologie   prevence a kontrola   MeSH
• prediktivní hodnota testů MeSH
• srdeční selhání MeSH
• tepový objem MeSH
• Check Tag
• lidé MeSH

AIMS: This trial was designed to test the hypothesis that shock efficacy during follow-up is not impaired in patients implanted without defibrillation (DF) testing during first implantable cardioverter-defibrillator (ICD) implantation. METHODS AND RESULTS: Between February 2011 and July 2013, 1077 patients were randomly assigned (1 : 1) to first time ICD implantation with (n = 540) or without (n = 537) DF testing. The intra-operative DF testing was standardized across all participating centres, and all ICD shocks were programmed to 40 J irrespective of DF test results. The primary end point was the average first shock efficacy (FSE) for all true ventricular tachycardia and fibrillation (VT/VF) episodes during follow-up. The secondary end points included procedural data, serious adverse events, and mortality. During a median follow-up of 22.8 months, the model-based FSE was found to be non-inferior in patients with an ICD implanted without a DF test, with a difference in FSE of 3.0% in favour of the no DF test [confidence interval (CI) -3.0 to 9.0%, Pnon-inferiority <0.001 for the pre-defined non-inferiority margin of -10%). A total of 112 procedure-related serious adverse events occurred within 30 days in 94 patients (17.6%) tested compared with 89 events in 74 patients (13.9%) not tested (P = 0.095). CONCLUSION: Defibrillation efficacy during follow-up is not inferior in patients with a 40 J ICD implanted without DF testing. Defibrillation testing during first time ICD implantation should no longer be recommended for routine left-sided ICD implantation.

• MeSH
• defibrilátory implantabilní škodlivé účinky   normy   MeSH
• elektrická defibrilace škodlivé účinky   normy   MeSH
• lidé středního věku MeSH
• lidé MeSH
• peroperační péče metody   mortalita   MeSH
• prospektivní studie MeSH
• tachykardie mortalita   terapie   MeSH
• výsledek terapie 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

Přehledná práce v první části pojednává o typech peroperačního testování implantabilních defibrilátorů, jejich výhodách a nevýhodách. Ve druhé části je diskutována otázka, zda je testování defibrilátorů nezbytné. Jsou probírány výhody a nevýhody testování a autor uzavírá, že vzhledem k tomu, že neexistují randomizované studie porovnávající rizika testování a netestování, není zatím tuto otázku možno jednoznačně odpovědět. Dokud nebudou k dispozici výsledky randomizovaných studií, tak se autor přiklání k omezenému testování, např. jedenkrát test na „defibrillation safety margin“.

This review contains in the first part the discussion about the various type of implantable-defibrillators testing, their advantages and disadvantages. In the second part the question is discussed, whether is the testing necessary. The advantage and disadvantages of testing are discussed. Author concludes that because there are no randomized studies, the question cannot be answered. Until the results of randomized studies are available, author recommends limited testing, e.g. single test for defibrillation safety margin.

• Klíčová slova
• defibrilační práh, safety margin, spodní limit vulnerability,
• MeSH
• analýza selhání vybavení MeSH
• bezpečnost vybavení MeSH
• chování snižující riziko MeSH
• defibrilátory implantabilní MeSH
• elektrická defibrilace škodlivé účinky   MeSH
• fibrilace komor prevence a kontrola   MeSH
• kardiostimulace umělá MeSH
• lékařská praxe - způsoby provádění MeSH
• lidé MeSH
• peroperační monitorování MeSH
• procedury zbytečné MeSH
• vyvolaná zástava srdce škodlivé účinky   MeSH
• Check Tag
• lidé MeSH
• Publikační typ
• přehledy MeSH

Aims: No standard practice exists with respect to anaesthesiologist-directed sedation (ADS) vs. sedation by proceduralist (PDS) for defibrillation threshold (DT) testing. We aimed to evaluate adverse events and safety outcomes with ADS vs. PDS for DT testing. Methods and results: A post hoc analysis of the Shockless Implant Evaluation (SIMPLE) study was performed among the 1242 patients who had DT testing (624 ADS and 618 PDS). We evaluated both intraoperative and in-hospital adverse composite events and two safety composite outcomes at 30-days of the main trial. Propensity score adjusted models were used to compute odds ratio (OR) and 95% confidence interval (CI) to evaluate the association between adverse and safety outcomes with method of sedation and independent predictors for use of ADS. Compared to PDS, patients who received ADS were younger (62 ± 12 years vs. 64 ± 12 years, P = 0.01), had lower ejection fraction (left ventricular ejection fraction 0.31 ± 13 vs. 0.33 ± 13, P = 0.03), were more likely to receive inhalational anaesthesia, propofol, or narcotics (P < 0.001, respectively) and receive an arterial line (43% vs. 8%, P = <0.0001). Independent predictors for ADS sedation were presence of coronary artery disease (OR 1.69, 95% CI 1.0-2.72; P = 0.03) and hypertrophic cardiomyopathy (OR 2.64, 95% CI 1.19-5.85; P = 0.02). Anaesthesiologist directed sedation had higher intraoperative adverse events (2.2% vs. 0.5%; OR 4.47, 95% CI 1.25-16.0; P = 0.02) and higher primary safety outcomes at 30 days (8.2% vs. 4.9%; OR 1.72 95% CI 1.06-2.80; P = 0.03) and no difference in other outcomes compared to PDS. Conclusion: Proceduralist-directed sedation is safe, however, this could be result of selection bias. Further research is needed.

• MeSH
• analgosedace * škodlivé účinky   metody   MeSH
• defibrilátory implantabilní * MeSH
• fibrilace komor terapie   MeSH
• hodnocení rizik MeSH
• hypnotika a sedativa * aplikace a dávkování   škodlivé účinky   MeSH
• implantace protézy * škodlivé účinky   přístrojové vybavení   metody   MeSH
• lidé středního věku MeSH
• lidé MeSH
• náhlá srdeční smrt etiologie   prevence a kontrola   MeSH
• pooperační komplikace * diagnóza   epidemiologie   etiologie   MeSH
• rizikové faktory MeSH
• senioři MeSH
• výsledky a postupy - zhodnocení (zdravotní péče) 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

BACKGROUND: A percutaneous intravascular cardioverter-defibrillator (PICD) has been developed with a right ventricular (RV) single-coil lead and titanium electrodes in the superior vena cava (SVC)-brachiocephalic vein (BCV) region and the inferior vena cava (IVC). OBJECTIVE: To compare defibrillation thresholds (DFTs) of the PICD with those of a conventional ICD in humans. METHODS: Ten patients with ischemic cardiomyopathy and ejection fraction ≤35% were randomized to initial testing with either PICD or conventional ICD. A standard dual-coil lead was positioned in the RV apex. If randomized to PICD, the device was placed into the vasculature such that 1 titanium electrode was positioned in the SVC-BCV region and the second in the IVC. For PICD DFTs, the RV coil of the conventional ICD lead was connected to the PICD mandrel [shock vector: RV (+) to SVC-BCV (-) + IVC (-)]. When testing the conventional ICD, a subcutaneous pocket was formed in the left pectoralis region and the ICD was connected to the lead system and positioned in the pocket [shock vector: RV (+) to SVC (-) + active can (-)]. Each device was removed before testing with the other. A step-down binary search protocol determined the DFT, with the initial shock being 9 J. RESULTS: The mean PICD DFT was 7.6 ± 3.3 J, and the conventional ICD system demonstrated a mean DFT of 9.5 ± 4.7 J (N = 10; paired t test, P = .28). CONCLUSION: The intravascular defibrillator has DFTs similar to those of commercially available ICDs.

• MeSH
• defibrilátory implantabilní * MeSH
• design vybavení MeSH
• kardiomyopatie terapie   MeSH
• lidé středního věku MeSH
• lidé MeSH
• senioři MeSH
• srdeční komory MeSH
• tepový objem 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
• srovnávací studie MeSH

AIM: To find out whether it is possible to anaesthetize patients safely without analgesia and sedation, using burst pacing prolonged until the patient becomes unconscious. METHODS: One hundred and four patients undergoing implantation or reimplantation of a cardioverter-defibrillator were included. Patients randomized into Group B underwent prolonged burst pacing without analgesia and sedation. Patients in Group T underwent a T-wave shock under analgesia and sedation. Blood samples for measurement of serum neuron-specific enolase were taken before surgery and 6, 24, and 48 h after the procedure. RESULTS: From the 104 patients, 51 were randomly assigned to Group B and 53 to Group T. Four patients from Group B were switched to Group T (ventricular fibrillation not induced by burst pacing). The clinical characteristics of both groups were similar. The mean total time of cardiac arrest was significantly longer in Group B (23.0 ± 4.4 s, median 22.7) vs. Group T (10.3 ± 3.0 s, median 10.0), P < 0.0001 (Mann-Whitney U-test). The effectiveness of both induction methods was similar (92.1% in Group B and 100% in Group T). The mean neuron-specific enolase levels after 6, 24, and 48 h were similar in Groups B and T (13.1 ± 6.3 and 11.6 ± 5.8 mg/L, 14.5 ± 7.5 and 13.4 ± 6.0 mg/L, and 14.9 ± 5.9 and 12.2 ± 6.0 mg/L, respectively) as were these levels compared with baseline neuron-specificenolase levels (14.0 ± 5.9 and 13.4 ± 4.0 mg/L, respectively), P = NS for all. CONCLUSION: Despite a longer time of total cardiac arrest, prolonged burst pacing appears to be a safe and effective method for induction of ventricular fibrillation during cardioverter-defibrillator testing, which enables omission of analgesia and sedation or general anaesthesia.

• MeSH
• analýza selhání vybavení přístrojové vybavení   metody   MeSH
• defibrilátory implantabilní škodlivé účinky   MeSH
• elektrická defibrilace přístrojové vybavení   metody   MeSH
• elektrofyziologické techniky kardiologické metody   MeSH
• fibrilace komor diagnóza   prevence a kontrola   MeSH
• lidé středního věku MeSH
• lidé MeSH
• senioři 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

BACKGROUND: The Shockless IMPLant Evaluation (SIMPLE) trial showed that defibrillation testing (DT) at the time of implantable cardioverter-defibrillator (ICD) implant did not improve shock efficacy or reduce mortality. There are no data regarding the risk of complications, including stroke, among patients with atrial fibrillation (AF) who undergo DT. OBJECTIVE: The purpose of this prospectively planned substudy of SIMPLE was to evaluate the effect of DT vs no DT on clinical outcomes among patients with AF. METHODS: We compared efficacy (failed appropriate shock/arrhythmic death) and safety between patients who had AF on their immediate preprocedural ECG to the rest of the study patients. Then among patients with AF we compared these outcomes between patients randomized to DT vs no DT. RESULTS: Of the 2500 patients enrolled in SIMPLE, 251 (10%) were in AF immediately before ICD implant. AF patients had an increased risk of failed appropriate shock/arrhythmic death (adjusted hazard ratio [HR] 1.64; 95% confidence interval [CI] 1.13-2.39; P = .009) and higher all-cause mortality (adjusted HR 1.58; 95% CI 1.2-2.08; P = .001). Among AF patients, perioperative complications and stroke did not significantly differ between DT vs no-DT groups (9.2% vs 5.4%; P = .2; and 1.7% vs 1.5%; P >.999, respectively). Failed appropriate shock or arrhythmic death occurred in 35 of 251 AF patients (14%), and the no-DT group proved not inferior to the DT group (HR 0.58; 95% CI 0.30-1.15; Pnoninferiority = .006). CONCLUSION: ICD recipients with AF are at increased risk for adverse outcomes; however, DT does not improve arrhythmic survival or shock efficacy. There is no evidence that DT increased the occurrence of perioperative stroke.

• MeSH
• defibrilátory implantabilní * MeSH
• elektrokardiografie * MeSH
• fibrilace síní mortalita   patofyziologie   terapie   MeSH
• lidé středního věku MeSH
• lidé MeSH
• míra přežití trendy   MeSH
• následné studie MeSH
• převodní systém srdeční patofyziologie   MeSH
• prospektivní 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
• multicentrická studie MeSH
• randomizované kontrolované studie MeSH
• Geografické názvy
• Evropa MeSH

The purpose of this trial was to determine whether microvolt T-wave alternans (MTWA) predicts ventricular tachyarrhythmic events (VTEs) in post-myocardial infarction patients with left ventricular ejection fraction (LVEF) < or =30%. BACKGROUND: Previous studies have established MTWA as a predictor for total and arrhythmic mortality, but its ability to identify prophylactic implantable cardioverter-defibrillator (ICD) recipients most likely to experience VTEs remains uncertain. METHODS: This prospective trial was conducted at 50 U.S. centers. Patients were eligible if they met MADIT-II (Multicenter Automatic Defibrillator Implantation Trial II) indications for device implant. All patients underwent MTWA testing followed by ICD implantation, with pre-specified programming to minimize the likelihood of therapies for non-life-threatening VTE. Minimum follow-up was 2 years with annual MTWA testing. Initially indeterminate MTWA tests were repeated. RESULTS: Analyses were conducted on 575 patients (84% male; average age +/- SD = 65 +/- 11 years; average LVEF +/- SD = 0.24 +/- 0.05). The final distribution of MTWA results were: MTWA positive in 293 (51%), MTWA negative in 214 (37%), and indeterminate in 68 patients (12%). Over an average follow-up of 2.1 +/- 0.9 years, there were 70 VTEs. A VTE occurred in 48 of 361 (13%, 6.3%/year) MTWA non-negative and 22 of 214 (10%, 5.0%/year) MTWA negative patients. A non-negative MTWA test result was not associated with VTE (hazard ratio: 1.26; 95% confidence interval: 0.76 to 2.09; p = 0.37), although total mortality was significantly increased (hazard ratio: 2.04; 95% confidence interval: 1.10 to 3.78; p = 0.02). CONCLUSIONS: In MADIT-II-indicated ICD-treated patients, the risk of VTE does not differ according to MTWA classification, despite differences in total mortality. (MASTER I-Microvolt T Wave Alternans Testing for Risk Stratification of Post MI Patients; NCT00305240).

• MeSH
• defibrilátory implantabilní MeSH
• funkční vyšetření srdce MeSH
• ischemická choroba srdeční diagnóza   komplikace   terapie   MeSH
• kardiomyopatie diagnóza   komplikace   terapie   MeSH
• komorová tachykardie diagnóza   etiologie   prevence a kontrola   MeSH
• lidé středního věku MeSH
• lidé MeSH
• prospektivní studie MeSH
• senioři MeSH
• Check Tag
• lidé středního věku MeSH
• lidé MeSH
• mužské pohlaví MeSH
• senioři MeSH
• ženské pohlaví 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

INTRODUCTION: Epicardial defibrillation systems currently require surgical access. We aimed to develop a percutaneous defibrillation system with partially-insulated epicardial coils to focus electrical energy on the myocardium and prevent or minimize extra-cardiac stimulation. METHODS: We tested 2 prototypes created for percutaneous introduction into the pericardial space via a steerable sheath. This included a partially-insulated defibrillation coil and a defibrillation mesh with a urethane balloon acting as an insulator to the face of the mesh not in contact with the epicardium. The average energy associated with a chance of successful defibrillation 75% of the time (ED75) was calculated for each experiment. RESULTS: Of 16 animal experiments, 3 pig experiments had malfunctioning mesh prototypes such that results were unreliable; these were excluded. Therefore, 13 animal experiments were analyzed - 6 canines (29.8±4.0kg); 7 pigs (41.1±4.4kg). The overall ED75 was 12.8±6.7J (10.9±9.1J for canines; 14.4±3.9J in pigs [P=0.37]). The lowest ED75 obtained in canines was 2.5J while in pigs it was 9.5J. The lowest energy resulting in successful defibrillation was 2J in canines and 5J in pigs. There was no evidence of coronary vessel injury or trauma to extra-pericardial structures. CONCLUSION: Percutaneous, epicardial defibrillation using a partially insulated coil is feasible and appears to be associated with low defibrillation thresholds. Focusing insulation may limit extra-cardiac stimulation and potentially lower energy requirements for efficient defibrillation.

• Publikační typ
• časopisecké články MeSH