Transvenous ICD
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- MeSH
- defibrilátory implantabilní trendy využití MeSH
- dospělí MeSH
- echokardiografie metody využití MeSH
- elektrokardiografie metody využití MeSH
- infarkt myokardu komplikace terapie MeSH
- katetrizační ablace metody využití MeSH
- komorová tachykardie etiologie komplikace terapie MeSH
- lidé MeSH
- Check Tag
- dospělí MeSH
- lidé MeSH
- mužské pohlaví MeSH
- Publikační typ
- kazuistiky MeSH
BACKGROUND: The subcutaneous implantable cardioverter-defibrillator (S-ICD) provides an alternative to the transvenous implantable cardioverter-defibrillator (TV-ICD). Patients undergoing TV-ICD explantation may be eligible for reimplantation with an S-ICD; however, information on safety outcomes in this complex population is limited. OBJECTIVE: This analysis was designed to provide outcome and safety data from S-ICD patients who received their device after TV-ICD explantation. METHODS: Patients in the S-ICD IDE Study and EFFORTLESS Registry with a prior TV-ICD explantation, as well as those with no prior implantable cardioverter-defibrillator (ICD), were included. Patients were divided into 3 groups: those implanted with the S-ICD after TV-ICD extraction for system-related infection (n = 75); those implanted after TV-ICD extraction for reasons other than system-related infection (n = 44); and patients with no prior ICD (de novo implantations, n = 747). RESULTS: Mean follow-up duration was 651 days, and all-cause mortality was low (3.2%). Patients previously explanted for TV-ICD infection were older (55.5 ± 14.6, 47.8 ± 14.3 and 49.9 ± 17.3 years in the infection, noninfection, and de novo cohorts, respectively; P = .01), were more likely to have received the ICD for secondary prevention (42.7%, 37.2% and 25.6%; P < 0.0001) and had higher percentages of comorbidities, including atrial fibrillation, congestive heart failure, diabetes mellitus, and hypertension, in line with the highest mortality rate (6.7%). Major infection after S-ICD implantation was low in all groups, with no evidence that patients implanted with the S-ICD after TV-ICD explantation for infection were more likely to experience a subsequent reinfection. CONCLUSION: The S-ICD is a suitable alternative for TV-ICD patients whose devices are explanted for any reason. Postimplantation risk of infection remains low even in patients whose devices were explanted for prior TV-ICD infection.
- MeSH
- analýza přežití MeSH
- defibrilátory implantabilní * škodlivé účinky statistika a číselné údaje MeSH
- dospělí MeSH
- elektrická defibrilace přístrojové vybavení metody MeSH
- implantace protézy * škodlivé účinky metody mortalita MeSH
- infekce chirurgické rány * diagnóza epidemiologie terapie MeSH
- komorová tachykardie terapie MeSH
- lidé středního věku MeSH
- lidé MeSH
- reoperace statistika a číselné údaje MeSH
- selhání zařízení statistika a číselné údaje 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
- práce podpořená grantem MeSH
- randomizované kontrolované studie MeSH
Arytmogenní kardiomyopatie pravé komory patří mezi poměrně vzácné příčiny kolapsových stavů. Nejčastějším podkladem ztráty vědomí jsou hemodynamicky závažné komorové tachykardie. U nemocných s arytmogenní kardiomyopatií a dokumentovanou komorovou tachykardií je jako prevence náhlé srdeční smrti indikována implantace kardioverteru-defi brilátoru (ICD). V popisovaném případě byla implantace ICD komplikována perforací komorové defi brilační elektrody do předního mediastina, s nutností extrakce a následnou reimplantací nové defi brilační elektrody do výtokového traktu pravé komory (RVOT). S odstupem jednoho týdne dochází k rozvoji septického stavu při mediastinitidě, perikarditidě a trombóze jugulární žíly, verifi kované ultrasonografi cky a CT hrudníku. Bylo nutné opětovně explantovat původní ICD systém a po přeléčení antibiotiky znovu reimplantovat nový, kdy byla elektroda cíleně umístěna na dolní septum. Nemocn
Arrhythmogenic right ventricular dysplasia is a rare cause of collapse, most frequently due to ventricular tachycardia. In patients with documented ventricular tachycardia, cardioverter-defi brillator (ICD) implantation to prevent sudden cardiac death is indicated. In the presented case, ICD implantation was complicated with a ventricular defi brillation lead perforating into front mediastinum requiring lead extraction and subsequent reimplantation of a new lead into the right ventricular outfl ow tract. A week later, the patient developed sepsis due to mediastinitis, pericarditis, and jugular vein thrombosis. Echocardiography and chest computer tomography were used to verify the diagnosis. The whole ICD system had to be explanted again, and after antibiotic treatment, a new one was reimplanted with septal positioning of the defi brillation lead. The patient continues to be
- MeSH
- antibakteriální látky terapeutické užití MeSH
- antikoagulancia terapeutické užití MeSH
- arytmogenní dysplazie pravé komory diagnóza komplikace MeSH
- dospělí MeSH
- elektrokardiografie metody využití MeSH
- kardiostimulace umělá metody škodlivé účinky využití MeSH
- katetrizační ablace metody využití MeSH
- koronární angiografie metody využití MeSH
- lidé středního věku MeSH
- lidé MeSH
- magnetická rezonanční tomografie metody využití MeSH
- mediastinitida diagnóza komplikace terapie MeSH
- počítačová rentgenová tomografie metody využití MeSH
- sepse etiologie farmakoterapie komplikace MeSH
- Check Tag
- dospělí MeSH
- lidé středního věku MeSH
- lidé MeSH
- mužské pohlaví MeSH
- Publikační typ
- kazuistiky MeSH
BACKGROUND: The subcutaneous implantable cardioverter-defibrillator (ICD) was designed to avoid complications related to the transvenous ICD lead by using an entirely extrathoracic placement. Evidence comparing these systems has been based primarily on observational studies. METHODS: We conducted a noninferiority trial in which patients with an indication for an ICD but no indication for pacing were assigned to receive a subcutaneous ICD or transvenous ICD. The primary end point was the composite of device-related complications and inappropriate shocks; the noninferiority margin for the upper boundary of the 95% confidence interval for the hazard ratio (subcutaneous ICD vs. transvenous ICD) was 1.45. A superiority analysis was prespecified if noninferiority was established. Secondary end points included death and appropriate shocks. RESULTS: A total of 849 patients (426 in the subcutaneous ICD group and 423 in the transvenous ICD group) were included in the analyses. At a median follow-up of 49.1 months, a primary end-point event occurred in 68 patients in the subcutaneous ICD group and in 68 patients in the transvenous ICD group (48-month Kaplan-Meier estimated cumulative incidence, 15.1% and 15.7%, respectively; hazard ratio, 0.99; 95% confidence interval [CI], 0.71 to 1.39; P = 0.01 for noninferiority; P = 0.95 for superiority). Device-related complications occurred in 31 patients in the subcutaneous ICD group and in 44 in the transvenous ICD group (hazard ratio, 0.69; 95% CI, 0.44 to 1.09); inappropriate shocks occurred in 41 and 29 patients, respectively (hazard ratio, 1.43; 95% CI, 0.89 to 2.30). Death occurred in 83 patients in the subcutaneous ICD group and in 68 in the transvenous ICD group (hazard ratio, 1.23; 95% CI, 0.89 to 1.70); appropriate shocks occurred in 83 and 57 patients, respectively (hazard ratio, 1.52; 95% CI, 1.08 to 2.12). CONCLUSIONS: In patients with an indication for an ICD but no indication for pacing, the subcutaneous ICD was noninferior to the transvenous ICD with respect to device-related complications and inappropriate shocks. (Funded by Boston Scientific; PRAETORIAN ClinicalTrials.gov number, NCT01296022.).
- MeSH
- defibrilátory implantabilní škodlivé účinky MeSH
- implantované elektrody škodlivé účinky MeSH
- incidence MeSH
- Kaplanův-Meierův odhad MeSH
- kardiomyopatie terapie MeSH
- lidé středního věku MeSH
- lidé MeSH
- náhlá srdeční smrt epidemiologie prevence a kontrola MeSH
- následné studie MeSH
- nemoci srdce terapie MeSH
- protézy - design MeSH
- selhání zařízení MeSH
- senioři MeSH
- srdeční arytmie terapie MeSH
- Check Tag
- lidé středního věku MeSH
- lidé MeSH
- mužské pohlaví MeSH
- senioři MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- hodnocení ekvivalence MeSH
- multicentrická studie MeSH
- práce podpořená grantem MeSH
- randomizované kontrolované studie MeSH
- srovnávací studie MeSH
BACKGROUND: The subcutaneous implantable cardioverter-defibrillator (S-ICD) is developed to overcome lead-related complications and systemic infections, inherent to transvenous ICD (TV-ICD) therapy. The PRAETORIAN trial demonstrated that the S-ICD is non-inferior to the TV-ICD with regard to the combined primary endpoint of inappropriate shocks and complications. This prespecified secondary analysis evaluates all complications in the PRAETORIAN trial. METHODS AND RESULTS: The PRAETORIAN trial is an international, multicentre, randomized trial in which 849 patients with an indication for ICD therapy were randomized to receive an S- ICD (N = 426) or TV-ICD (N = 423) and followed for a median of 49 months. Endpoints were device-related complications, lead-related complications, systemic infections, and the need for invasive interventions. Thirty-six device-related complications occurred in 31 patients in the S-ICD group of which bleedings were the most frequent. In the TV-ICD group, 49 complications occurred in 44 patients of which lead dysfunction was most frequent (HR: 0.69; P = 0.11). In both groups, half of all complications were within 30 days after implantation. Lead-related complications and systemic infections occurred significantly less in the S-ICD group compared with the TV-ICD group (P < 0.001, P = 0.03, respectively). Significantly more complications required invasive interventions in the TV-ICD group compared with the S-ICD group (8.3% vs. 4.3%, HR: 0.59; P = 0.047). CONCLUSION: This secondary analysis shows that lead-related complications and systemic infections are more prevalent in the TV-ICD group compared with the S-ICD group. In addition, complications in the TV-ICD group were more severe as they required significantly more invasive interventions. This data contributes to shared decision-making in clinical practice.
The first clinical results from the Evaluation of Factors Impacting Clinical Outcome and Cost Effectiveness of the subcutaneous implantable cardioverter defibrillator (EFFORTLESS S-ICD) Registry on the entirely S-ICD system are promising, but the impact of the S-ICD system on patients' quality of life (QoL) is not known. We evaluated the QoL of patients with an S-ICD against an unrelated cohort with a transvenous (TV)-ICD system during 6 months of follow-up. Consecutively implanted patients with an S-ICD system were matched with patients with a TV-ICD system on a priori selected variables including baseline QoL. QoL was measured with the Short-Form Health Survey at baseline, 3, and 6 months after implant and compared using multivariable modeling with repeated measures. Patients with an S-ICD (n = 167) versus a TV-ICD system (n = 167) did not differ significantly on physical (p = 0.8157) and mental QoL scores (p = 0.9080) across baseline, 3, and 6 months after implantation in adjusted analyses. The evolution in physical (p = 0.0503) and mental scores (p = 0.3772) during follow-up was similar for both cohorts, as indicated by the nonsignificant interaction effect for ICD system by time. Both patients with an S-ICD system and a TV-ICD system experienced significant improvements in physical and mental QoL between time of implant and 3 months (both p's <0.0001) and between time of implant and 6 months (both p's <0.0001) but not between 3 and 6 months (both p's >0.05). In conclusion, these first results show that the QoL of patients with an S-ICD versus TV-ICD system is similar and that patients with either system experience improvements in QoL on the short term.
- MeSH
- činnosti denního života MeSH
- defibrilátory implantabilní * MeSH
- dospělí MeSH
- fibrilace komor komplikace terapie MeSH
- implantace protézy metody MeSH
- komorová tachykardie komplikace terapie MeSH
- kvalita života * MeSH
- lidé středního věku MeSH
- lidé MeSH
- multivariační analýza MeSH
- náhlá srdeční smrt etiologie prevence a kontrola MeSH
- prospektivní studie MeSH
- registrace * MeSH
- senioři MeSH
- Check Tag
- dospělí MeSH
- 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
In patients with ventricular tachycardia (VT) and a history of myocardial infarction, intervention with an implantable cardioverter defibrillator (ICD) can prevent sudden cardiac death and thereby reduce total mortality. However, ICD shocks are painful and do not provide complete protection against sudden cardiac death. We assessed the potential benefit of catheter ablation before implantation of a cardioverter defibrillator. METHODS: The Ventricular Tachycardia Ablation in Coronary Heart Disease (VTACH) study was a prospective, open, randomised controlled trial, undertaken in 16 centres in four European countries. Patients aged 18-80 years were eligible for enrolment if they had stable VT, previous myocardial infarction, and reduced left-ventricular ejection fraction (LVEF;
- MeSH
- defibrilátory implantabilní MeSH
- dospělí MeSH
- financování organizované MeSH
- katetrizační ablace metody MeSH
- komorová tachykardie chirurgie terapie MeSH
- koronární nemoc komplikace MeSH
- lidé středního věku MeSH
- lidé MeSH
- mladiství MeSH
- následné studie MeSH
- randomizované kontrolované studie jako téma MeSH
- senioři nad 80 let MeSH
- senioři MeSH
- výsledek terapie MeSH
- Check Tag
- dospělí MeSH
- lidé středního věku MeSH
- lidé MeSH
- mladiství MeSH
- mužské pohlaví MeSH
- senioři nad 80 let MeSH
- senioři MeSH
- ženské pohlaví MeSH
- Publikační typ
- multicentrická studie MeSH
AIMS: The purpose of this prospective randomized study was to evaluate the safety and efficacy of transvenous pacemaker and implantable cardioverter-defibrillator (ICD) lead extraction with an electrosurgical dissection sheath (EDS) system in a single-centre experience. Methods Over 10 years, 462 patients have undergone transvenous lead extraction in our institution. From these, 120 consecutive patients (with 161 leads) were randomized to either radiofrequency (RF) current supported extraction or standard countertraction lead removal (60 patients in each arm, 96 men and 24 women). The mean age of randomized patients was 62.7 +/- 9.6 years. In 16 patients, we explanted 17 ICD leads. The average time from the date of implantation to the extraction procedure was 73.4 +/- 15.7 months. The most common reason for lead extraction was infection (95.6%). Results The complete extraction of 78 leads (93%) was achieved in the RF group and 56 leads (73%) with the standard transvenous lead extraction system by counter-traction (P < 0.01). Among these leads, we successfully removed nine of 10 ICD leads (90%) in the RF group and only four of seven ICD leads (57%) in the standard group. We also observed a significant reduction in the time taken for the successful removal of pacemaker and ICD leads using the RF system (9.6 +/- 6.2 min versus 21 +/- 9 min, P < 0.01). Partial success was achieved in six patients with the RF system and in 11 with standard sheaths. In those cases where we failed to remove the lead from the body we sent all but one patient to cardiac surgery. Serious complications were associated with the standard system in two patients, both of whom developed septic pulmonary embolization. Serious bleeding occurred in three patients, one with standard and two with the EDS lead extraction system. CONCLUSION: The EDS extraction system is significantly more effective and quicker. However, the standard counter-traction method is still an effective alternative when used in a highly experienced centre.
- MeSH
- bakteriální infekce komplikace MeSH
- chirurgické nástroje MeSH
- implantované elektrody MeSH
- interval spolehlivosti MeSH
- kardiostimulátor škodlivé účinky MeSH
- lidé MeSH
- odstranění implantátu metody MeSH
- prospektivní studie MeSH
- rozdělení chí kvadrát MeSH
- selhání zařízení MeSH
- senioři MeSH
- výsledek terapie MeSH
- Check Tag
- lidé MeSH
- mužské pohlaví MeSH
- senioři MeSH
- ženské pohlaví MeSH
- Publikační typ
- randomizované kontrolované studie 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
