- MeSH
- dvojčata abnormality MeSH
- lidé MeSH
- mnohočetné abnormality patologie MeSH
- novorozenec MeSH
- radiografie MeSH
- tomografie MeSH
- Check Tag
- lidé MeSH
- novorozenec MeSH
- Publikační typ
- kazuistiky MeSH
- MeSH
- absces jater chirurgie MeSH
- absces chirurgie MeSH
- antibakteriální látky terapeutické užití MeSH
- břicho chirurgie MeSH
- cholecystektomie MeSH
- dospělí MeSH
- drenáž MeSH
- lidé středního věku MeSH
- lidé MeSH
- pooperační komplikace MeSH
- senioři MeSH
- Check Tag
- dospělí MeSH
- lidé středního věku MeSH
- lidé MeSH
- senioři MeSH
- MeSH
- informační systémy MeSH
- mozek MeSH
- pneumoencefalografie MeSH
- psychiatrie MeSH
- psychopatologie MeSH
- radiografie MeSH
- Publikační typ
- srovnávací studie MeSH
American journal of obstetrics and gynecology, ISSN 0002-9378 Supplement Vol. 179. 3
6A, S37-S86 s. ; 30 cm
INTRODUCTION: Catheter ablation is an effective treatment of scar-related ventricular tachycardia (VT), but the overall complexity of the procedure has precluded its widespread use. Remote magnetic navigation (RMN) has been shown to facilitate cardiac mapping and ablation of VT in a retrospective series. STOP-VT is the first multicenter, prospective, single-arm and single-procedure study evaluating RMN-based mapping and ablation of post-infarction VT. METHODS: Patients with documented VT and prior MI, in whom an ICD was implanted either for primary or secondary prevention, were recruited from four EU and US centers. Either a transseptal (48 patients) or transaortic (5 patients) approach was employed to gain access for ventricular endocardial mapping/ablation during VT (entrainment mapping, activation mapping) and/or substrate mapping in sinus rhythm (elimination of fractionated/late potentials, variable extent of substrate modification) with RMN and irrigated RF ablation. The primary endpoints were as follows: (i) non-inducibility of the target VT or any other sustained VT; (ii) elimination of sustained VT/VF during ICD follow-up of up to 12 months. RESULTS: The cohort included 53 consecutive patients (median age 67 years, 49 men, median LVEF 31%). One hemodynamically unstable patient was excluded at the onset of mapping. Inducibility of sustained VT was achieved an average of 2.2 times per patient (1-8), with mean tachycardia cycle length (TCL) 374 milliseconds (179-510). Mean total procedure and fluoroscopy times were 223 minutes and 8.7 minutes, respectively; mean cumulative fluoroscopy time during mapping and ablation was 0.95 minutes; maximum power averaged 42.3 W with nominal saline 30 cc/min irrigation; mean cumulative RF time was 38 minutes. Non-inducibility of the target VT was achieved in 49/52 patients (94.2%) and non-inducibility of any VT was achieved in 38/52 patients (73.1%). A combination of RMN and manual ablation was performed in two patients, rendering one non-inducible. During the 12-month ICD follow-up period, freedom from any sustained VT/VF was observed in 30 patients (62%), of which 19 (63%) were off antiarrhythmic medications. Five patients expired during follow-up: one presented with a VT storm, but for the others, death was not related to VT/VF (MI-cardiogenic shock, pulmonary embolism, bronchogenic carcinoma, end stage heart failure). No procedural complications were reported. CONCLUSIONS: This first prospective, single-procedure, multicenter study indicates that remote magnetic navigation is a safe and effective method for catheter ablation of post-infarction VT.
- MeSH
- internacionalita * MeSH
- katetrizační ablace metody MeSH
- kohortové studie MeSH
- komorová tachykardie diagnóza chirurgie MeSH
- lidé středního věku MeSH
- lidé MeSH
- magnetické jevy * MeSH
- následné studie MeSH
- prospektivní studie MeSH
- roboticky asistované výkony metody MeSH
- senioři 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
PURPOSE: Patients with ischemic cardiomyopathy (ICM) are prone to scar-related ventricular tachycardia (VT). The success of VT ablation depends on accurate arrhythmogenic substrate localization, followed by optimal delivery of energy provided by constant electrode-tissue contact. Current manual and remote magnetic navigation (RMN)-guided ablation strategies aim to identify a reentry circuit and to target a critical isthmus through activation and entrainment mapping during ongoing tachycardia. The MAGNETIC VT trial will assess if VT ablation using the Niobe™ ES magnetic navigation system results in superior outcomes compared to a manual approach in subjects with ischemic scar VT and low ejection fraction. METHODS AND RESULTS: This is a randomized, single-blind, prospective, multicenter post-market study. A total of 386 subjects (193 per group) will be enrolled and randomized 1:1 between treatment with the Niobe ES system and treatment via a manual procedure at up to 20 sites. The study population will consist of patients with ischemic cardiomyopathy with left ventricular ejection fraction (LVEF) of ≤35% and implantable cardioverter defibrillator (ICD) who have sustained monomorphic VT. The primary study endpoint is freedom from any recurrence of VT through 12 months. The secondary endpoints are acute success; freedom from any VT at 1 year in a large-scar subpopulation; procedure-related major adverse events; and mortality rate through 12-month follow-up. Follow-up will consist of visits at 3, 6, 9, and 12 months, all of which will include ICD interrogation. CONCLUSIONS: The MAGNETIC VT trial will help determine whether substrate-based ablation of VT with RMN has clinical advantages over manual catheter manipulation. TRIAL REGISTRATION: Clinicaltrials.gov identifier: NCT02637947.
- MeSH
- dospělí MeSH
- dysfunkce levé srdeční komory diagnostické zobrazování etiologie prevence a kontrola MeSH
- jednoduchá slepá metoda MeSH
- katetrizační ablace metody MeSH
- komorová tachykardie komplikace diagnostické zobrazování chirurgie MeSH
- lidé středního věku MeSH
- lidé MeSH
- magnetismus MeSH
- mapování potenciálů tělesného povrchu metody MeSH
- mladiství MeSH
- mladý dospělý MeSH
- senioři nad 80 let MeSH
- senioři MeSH
- tepový objem MeSH
- výsledek terapie MeSH
- Check Tag
- dospělí MeSH
- lidé středního věku MeSH
- lidé MeSH
- mladiství MeSH
- mladý dospělý MeSH
- mužské pohlaví MeSH
- senioři nad 80 let MeSH
- senioři MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- multicentrická studie MeSH
- randomizované kontrolované studie MeSH
- Geografické názvy
- Spojené státy americké MeSH
BACKGROUND: Catheter ablation using radiofrequency (RF) energy is an established treatment for ventricular tachycardia (VT). Tissue temperature is a key determinant of successful lesion creation, and yet, it is difficult to measure during conventional RF ablation because of the cooling effect of high-flow rate saline irrigation. The TRAC-VT study evaluated the safety and efficacy of a novel irrigated RF ablation system modulating power based on real-time tissue temperature. METHODS: Patients with sustained monomorphic VT and structural heart disease (SHD) were enrolled. Catheter ablation was performed in temperature-control mode (irrigation 8 ml/min, temperature set-points 55 or 60 °C, and power output ≤ 50 W), with RF applications for ≤ 45 s. The primary safety endpoint was a composite of cardiovascular-specific serious procedure-related adverse events within 30 days post-ablation. The primary effectiveness endpoint was acute success (i.e., non-inducibility of all clinically relevant VTs). RESULTS: Thirty-eight patients were enrolled with monomorphic VT (age 68 ± 12 years and 84% male), with an average of 1.7 ± 1.2 VTs targeted per patient. In total, 41 ± 23 RF applications per patient were delivered. Acute procedural success was 100% (95% CI, 91-100%). No primary safety endpoints were observed. Six-month follow-up was completed in 92% of patients with 81% (95% CI, 65-91%) freedom from sustained or treated VT. A repeat ablation was performed in three patients. CONCLUSIONS: Ablation of VT in SHD, using a temperature-controlled irrigated RF catheter, was safe and effective with a low rate of VT recurrence at 6 months.
- MeSH
- design vybavení MeSH
- katetrizační ablace * metody přístrojové vybavení škodlivé účinky MeSH
- komorová tachykardie * chirurgie mortalita MeSH
- léčebná irigace metody přístrojové vybavení MeSH
- lidé středního věku MeSH
- lidé 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
- pozorovací studie MeSH