Pulse field ablation (PFA) has gained attention in the field of atrial fibrillation catheter treatment recently. All currently used or developed technologies use ultrashort pulses (on the order of microseconds). The Emerging CellFX System (Pulse Biosciences, Inc, Inc) utilizes nanosecond PFA (nsPFA) and is thus several orders of magnitude shorter than the initial PFA systems. There are several potential advantages of nsPFA over microsecond PFA such as deeper penetration of the electric field into tissue, creating larger and deeper ablation zones while depositing less overall energy and heat, faster treatment, and less muscle stimulation or nerve capture.
BACKGROUND: Strokes after left atrial appendage closure (LAAC) prophylaxis are generally less severe than those after warfarin prophylaxis-thought to be secondary to more hemorrhagic strokes with warfarin. Hemorrhagic strokes are similarly infrequent with direct oral anticoagulant (DOAC) prophylaxis, so the primary subtype after either LAAC or DOAC prophylaxis is ischemic stroke (IS). OBJECTIVES: The purpose of this study was to compare the severity of IS using the modified Rankin Scale in atrial fibrillation patients receiving prophylaxis with DOACs vs LAAC. METHODS: A retrospective analysis was performed of consecutive patients undergoing LAAC at 8 centers who developed an IS (ISLAAC) compared with contemporaneous consecutive patients who developed IS during treatment with DOACs (ISDOAC). The primary outcome was disabling/fatal stroke (modified Rankin Scale 3-5) at discharge and 3 months later. RESULTS: Compared with ISDOAC patients (n = 322), ISLAAC patients (n = 125) were older (age 77.2 ± 13.4 years vs 73.1 ± 11.9 years; P = 0.002), with higher HAS-BLED scores (3.0 vs 2.0; P = 0.004) and more frequent prior bleeding events (54.4% vs 23.6%; P < 0.001), but similar CHA2DS2-VASc scores (5.0 vs 5.0; P = 0.28). Strokes were less frequently disabling/fatal with ISLAAC than ISDOAC at both hospital discharge (38.3% vs 70.3%; P < 0.001) and 3 months later (33.3% vs 56.2%; P < 0.001). Differences in stroke severity persisted after propensity score matching. By multivariate regression analysis, ISLAAC was independently associated with fewer disabling/fatal strokes at discharge (OR: 0.22; 95% CI: 0.13-0.39; P < 0.001) and 3 months (OR: 0.25; 95% CI: 0.12-0.50; P < 0.001), and fewer deaths at 3 months (OR: 0.28; 95% CI: 0.12-0.64; P < 0.001). CONCLUSIONS: Ischemic strokes in patients with atrial fibrillation are less often disabling or fatal with LAAC than DOAC prophylaxis.
- MeSH
- antikoagulancia škodlivé účinky MeSH
- cévní mozková příhoda * epidemiologie etiologie prevence a kontrola MeSH
- fibrilace síní * komplikace farmakoterapie chirurgie MeSH
- hemoragická cévní mozková příhoda * chemicky indukované komplikace farmakoterapie MeSH
- ischemická cévní mozková příhoda * chemicky indukované komplikace farmakoterapie MeSH
- krvácení chemicky indukované MeSH
- lidé středního věku MeSH
- lidé MeSH
- retrospektivní studie MeSH
- senioři nad 80 let MeSH
- senioři MeSH
- uzávěr ouška levé síně MeSH
- výsledek terapie MeSH
- warfarin škodlivé účinky MeSH
- Check Tag
- lidé středního věku MeSH
- lidé MeSH
- senioři nad 80 let MeSH
- senioři MeSH
- Publikační typ
- časopisecké články MeSH
AIMS: We report our single-centre experience of mid-term to long-term retrieval and reimplantation of a tine-based leadless pacemaker [Micra transcatheter pacing system (TPS)]. The TPS is a clinically effective alternative to transvenous single-chamber ventricular pacemakers. Whereas it is currently recommended to abandon the TPS at the end of device life, catheter-based retrieval may be favourable in specific scenarios. METHODS AND RESULTS: We report on nine consecutive patients with the implanted TPS who subsequently underwent transcatheter retrieval attempts. The retrieval system consists of the original TPS delivery catheter and an off-the-shelf single-loop 7 mm snare. The procedure was guided by fluoroscopy and intracardiac echocardiography. After an implantation duration of 3.1 ± 2.8 years (range 0.4-9.0), the overall retrieval success rate was 88.9% (8 of 9 patients). The mean procedure time was 89 ± 16 min, and the fluoroscopy time was 18.0 ± 6.6 min. No procedure-related adverse device events occurred. In the one unsuccessful retrieval, intracardiac echocardiography revealed that the TPS was partially embedded in the ventricular tissue surrounding the leadless pacemaker body in the right ventricle. After retrieval, three patients were reimplanted with a new TPS device. All implantations were successful without complications. CONCLUSION: A series of transvenous late retrievals of implanted TPS devices demonstrated safety and feasibility, followed by elective replacement with a new leadless pacing device or conventional transvenous pacing system. This provides a viable end-of-life management alternative to simple abandonment of this leadless pacemaker.
- MeSH
- časové faktory MeSH
- design vybavení MeSH
- echokardiografie MeSH
- intervenční radiografie MeSH
- kardiostimulace umělá metody MeSH
- kardiostimulátor * MeSH
- lidé středního věku MeSH
- lidé MeSH
- odstranění implantátu * metody MeSH
- senioři nad 80 let MeSH
- senioři MeSH
- srdeční katetrizace * metody přístrojové vybavení MeSH
- srdeční katétry MeSH
- výsledek terapie MeSH
- Check Tag
- lidé středního věku MeSH
- lidé MeSH
- mužské pohlaví MeSH
- senioři nad 80 let MeSH
- senioři MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
Pulsed field ablation (PFA) is an emerging technology for the treatment of atrial fibrillation (AF), for which pre-clinical and early-stage clinical data are suggestive of some degree of preferentiality to myocardial tissue ablation without damage to adjacent structures. Here in the MANIFEST-17K study we assessed the safety of PFA by studying the post-approval use of this treatment modality. Of the 116 centers performing post-approval PFA with a pentaspline catheter, data were received from 106 centers (91.4% participation) regarding 17,642 patients undergoing PFA (mean age 64, 34.7% female, 57.8% paroxysmal AF and 35.2% persistent AF). No esophageal complications, pulmonary vein stenosis or persistent phrenic palsy was reported (transient palsy was reported in 0.06% of patients; 11 of 17,642). Major complications, reported for ~1% of patients (173 of 17,642), were pericardial tamponade (0.36%; 63 of 17,642) and vascular events (0.30%; 53 of 17,642). Stroke was rare (0.12%; 22 of 17,642) and death was even rarer (0.03%; 5 of 17,642). Unexpected complications of PFA were coronary arterial spasm in 0.14% of patients (25 of 17,642) and hemolysis-related acute renal failure necessitating hemodialysis in 0.03% of patients (5 of 17,642). Taken together, these data indicate that PFA demonstrates a favorable safety profile by avoiding much of the collateral damage seen with conventional thermal ablation. PFA has the potential to be transformative for the management of patients with AF.
- MeSH
- fibrilace síní * chirurgie terapie MeSH
- katetrizační ablace * škodlivé účinky metody MeSH
- lidé středního věku MeSH
- lidé MeSH
- pooperační komplikace epidemiologie etiologie 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
BACKGROUND: Electrographic flow (EGF) mapping enables full spatiotemporal reconstruction of organized wavefront propagation to identify extrapulmonary vein sources of atrial fibrillation (AF). OBJECTIVES: FLOW-AF (A Randomized Controlled Study to Evaluate the Reliability of the Ablacon Electrographic FLOW [EGF] Algorithm Technology [Ablamap Software] to Identify AF Sources and Guide Ablation Therapy in Patients With Persistent Atrial Fibrillation) was multicenter, randomized controlled study of EGF mapping to: 1) stratify a nonparoxysmal AF population undergoing redo ablation; 2) guide ablation of these extrapulmonary vein AF sources; and 3) improve AF recurrence outcomes. METHODS: FLOW-AF enrolled persistent atrial fibrillation (PerAF)/long-standing PerAF patients undergoing redo ablation at 4 centers. One-minute EGF maps were recorded from standardized biatrial basket positions. Patients with source activity ≥26.5% were randomized 1:1 to PVI + EGF-guided ablation vs PVI only; patients without sources ≥26.5% threshold were not randomized. Follow-up and electrocardiographic monitoring occurred at 3, 6, and 12 months. RESULTS: We enrolled 85 patients (age 65.6 ± 9.3 years, 37% female, 24% long-standing PerAF). Thirty-four (40%) patients had no sources greater than threshold; at least 1 source greater than threshold was present in 46 (60%) (EGF-guided ablation, n = 22; control group, n = 26). Patients with sources were older (68.2 vs 62.6 years; P = 0.005) with higher CHA2DS2-VASc scores (2.8 vs 1.9; P = 0.001). The freedom from safety events was 97.2%, and 95% of EGF-identified sources were successfully ablated. In randomized patients, AF-free survival at 12 months was 68% for EGF-guided ablation vs 17% for the control group (P = 0.042); freedom from AF/atrial tachycardia/atrial flutter at 12 months was 51% vs 14% (P = 0.103), respectively. CONCLUSIONS: In nonparoxysmal AF patients undergoing redo ablation, EGF mapping identified AF sources in 60% of patients, and could be successfully ablated in 95%. Compared with PVI alone, PVI + source ablation improved AF-free survival by 51% on an absolute basis. (FLOW-AF: A Study to Evaluate the Ablacon Electrographic FLOW EGF Technology [A Randomized Controlled Study to Evaluate the Reliability of the Ablacon Electrographic FLOW (EGF) Algorithm Technology (Ablamap Software) to Identify AF Sources and Guide Ablation Therapy in Patients With Persistent Atrial Fibrillation]; NCT04473963).
- MeSH
- algoritmy MeSH
- elektrofyziologické techniky kardiologické metody MeSH
- elektrokardiografie MeSH
- fibrilace síní * chirurgie patofyziologie MeSH
- katetrizační ablace * metody škodlivé účinky MeSH
- lidé středního věku MeSH
- lidé MeSH
- reoperace statistika a číselné údaje 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
BACKGROUND: During pulsed field ablation (PFA), electrode-tissue proximity optimizes lesion quality. A novel "single-shot" map-and-ablate spherical multielectrode PFA array catheter that is able to verify electrode-tissue contact was recently studied in a first-in-human trial of atrial fibrillation (AF). OBJECTIVE: The aim of this study was to report lesion durability data, safety, and 12-month effectiveness outcomes. METHODS: The spherical PFA catheter, an all-in-one mapping and ablation system, was used to render anatomy and to deliver biphasic pulses (ungated 1.7 kV pulses; ∼40 seconds/application). Ablation sites included pulmonary veins (PVs) and, in selected patients, posterior wall and mitral isthmus. Follow-up was invasive remapping at ∼3 months, electrocardiograms, Holter monitoring at 6 and 12 months, and symptomatic and scheduled transtelephonic monitoring. The primary and secondary efficacy end points were acute PV isolation (PVI), PVI durability, and atrial arrhythmia recurrence. RESULTS: In the 48-patient AF cohort (paroxysmal, 48%; persistent, 52%), lesion sets included PVI (n = 48; 1.2 applications/PV), posterior wall (n = 20; 3.6 applications/posterior wall), and mitral isthmus (n = 11; 2.9 applications/mitral isthmus). Lesions were acutely successful for all 187 of 187 PVs (100%), 20 of 20 posterior walls (100%), and 10 of 11 mitral isthmuses (91%). Pulse delivery time, left atrial catheter dwell time, and procedure time were 61.5 ± 32.8 seconds, 53.9 ± 26.5 minutes, and 87.8 ± 29.8 minutes, respectively. Remapping (43/48 patients [89.5%]) revealed that 158 of 169 PVs (93.5%) were durably isolated. The only complication was a drug-responsive pericarditis. The 1-year Kaplan-Meier estimates of freedom from atrial arrhythmia were 84.2% (paroxysmal AF) and 80.0% (persistent AF). CONCLUSION: The single-shot spherical array PFA catheter can safely achieve durable lesions, translating into good clinical efficacy.
- MeSH
- časové faktory MeSH
- design vybavení MeSH
- elektrokardiografie ambulantní metody MeSH
- fibrilace síní * chirurgie patofyziologie MeSH
- katetrizační ablace * metody přístrojové vybavení MeSH
- lidé středního věku MeSH
- lidé MeSH
- následné studie MeSH
- převodní systém srdeční patofyziologie MeSH
- recidiva MeSH
- senioři MeSH
- venae pulmonales * chirurgie 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
AIMS: Pulsed field ablation (PFA) has significant advantages over conventional thermal ablation of atrial fibrillation (AF). This first-in-human, single-arm trial to treat paroxysmal AF (PAF) assessed the efficiency, safety, pulmonary vein isolation (PVI) durability and one-year clinical effectiveness of an 8 Fr, large-lattice, conformable single-shot PFA catheter together with a dedicated electroanatomical mapping system. METHODS AND RESULTS: After rendering the PV anatomy, the PFA catheter delivered monopolar, biphasic pulse trains (5-6 s per application; ∼4 applications per PV). Three waveforms were tested: PULSE1, PULSE2, and PULSE3. Follow-up included ECGs, Holters at 6 and 12 months, and symptomatic and scheduled transtelephonic monitoring. The primary and secondary efficacy endpoints were acute PVI and post-blanking atrial arrhythmia recurrence, respectively. Invasive remapping was conducted ∼75 days post-ablation. At three centres, PVI was performed by five operators in 85 patients using PULSE1 (n = 30), PULSE2 (n = 20), and PULSE3 (n = 35). Acute PVI was achieved in 100% of PVs using 3.9 ± 1.4 PFA applications per PV. Overall procedure, transpired ablation, PFA catheter dwell and fluoroscopy times were 56.5 ± 21.6, 10.0 ± 6.0, 19.1 ± 9.3, and 5.7 ± 3.9 min, respectively. No pre-defined primary safety events occurred. Upon remapping, PVI durability was 90% and 99% on a per-vein basis for the total and PULSE3 cohort, respectively. The Kaplan-Meier estimate of one-year freedom from atrial arrhythmias was 81.8% (95% CI 70.2-89.2%) for the total, and 100% (95% CI 80.6-100%) for the PULSE3 cohort. CONCLUSION: Pulmonary vein isolation (PVI) utilizing a conformable single-shot PFA catheter to treat PAF was efficient, safe, and effective, with durable lesions demonstrated upon remapping.
- MeSH
- akční potenciály MeSH
- časové faktory MeSH
- design vybavení MeSH
- elektrofyziologické techniky kardiologické MeSH
- fibrilace síní * chirurgie patofyziologie diagnóza MeSH
- katetrizační ablace * metody přístrojové vybavení MeSH
- lidé středního věku MeSH
- lidé MeSH
- recidiva * MeSH
- senioři MeSH
- srdeční frekvence MeSH
- srdeční katétry * MeSH
- venae pulmonales * chirurgie 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
- klinické zkoušky MeSH
- multicentrická studie MeSH
- práce podpořená grantem MeSH
BACKGROUND: In treating atrial fibrillation, pulsed-field ablation (PFA) has comparable efficacy to conventional thermal ablation, but with important safety advantages: no esophageal injury or pulmonary vein stenosis, and rare phrenic nerve injury. However, when PFA is delivered in proximity to coronary arteries using a pentaspline catheter, which generates a broad electrical field, severe vasospasm can be provoked. OBJECTIVES: The authors sought to study the vasospastic potential of a focal PFA catheter with a narrower electrical field and develop a preventive strategy with nitroglycerin. METHODS: During atrial fibrillation ablation, a focal PFA catheter was used for cavotricuspid isthmus ablation. Angiography of the right coronary artery (some with fractional flow reserve measurement) was performed before, during, and after PFA. Beyond no nitroglycerin (n = 5), and a few testing strategies (n = 8), 2 primary nitroglycerin administration strategies were studied: 1) multiple boluses (3-2 mg every 2 min) into the right atrium (n = 10), and 2) a bolus (3 mg) into the right atrium with continuous peripheral intravenous infusion (1 mg/min; n = 10). RESULTS: Without nitroglycerin, cavotricuspid isthmus ablation provoked moderate-severe vasospasm in 4 of 5 (80%) patients (fractional flow reserve 0.71 ± 0.08). With repetitive nitroglycerin boluses, severe spasm did not occur, and mild-moderate vasospasm occurred in only 2 of 10 (20%). Using the bolus + infusion strategy, severe and mild-moderate spasm occurred in 1 and 3 of 10 patients (aggregate 40%). No patient had ST-segment changes. CONCLUSIONS: Ablation of the cavotricuspid isthmus using a focal PFA catheter routinely provokes right coronary vasospasm. Pretreatment with high doses of parenteral nitroglycerin prevents severe spasm.
- MeSH
- fibrilace síní * chirurgie MeSH
- katetrizační ablace * metody škodlivé účinky MeSH
- koronární angiografie MeSH
- koronární cévy účinky léků chirurgie patofyziologie MeSH
- koronární vazospasmus * prevence a kontrola MeSH
- lidé středního věku MeSH
- lidé MeSH
- nitroglycerin * aplikace a dávkování terapeutické užití MeSH
- senioři MeSH
- vazodilatancia terapeutické užití aplikace a dávkování MeSH
- Check Tag
- lidé středního věku MeSH
- lidé MeSH
- mužské pohlaví MeSH
- senioři MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
BACKGROUND: Visually guided laser balloon ablation is known as an effective pulmonary vein (PV) isolation device. The third-generation laser balloon ablation system (X3) equipped with compliant balloon and an automated motor-driven laser output mechanism, namely RAPID mode, has been clinically proven for PV isolation. METHODS: PV isolation with X3 was performed in all the patients with paroxysmal and early-stage persistent atrial fibrillation (AF). Acute data for PV isolation and clinical outcomes including supraventricular tachyarrhythmia (SVT: AF, atrial flutter, or atrial tachycardia)-free survival rate beyond 1 year were analyzed. RESULTS: A total of 110 patients (62 ± 13 years old, 80% of paroxysmal AF) were treated with X3. RAPID mode with was utilized to achieve PV isolation in all cases. In combination with RAPID mode and spot mode laser ablation, 91.1% (380/417) of veins were isolated on the first circumferential lesion set and did not require touch-up ablation and during the index procedure 100% of attempted veins were isolated. The mean procedure time was 77.0 ± 22.7 min and LA dwell time was 61.9 ± 22.0 min. Total duration of laser application was 5.1 ± 2.3 min per vein. At 1 year, SVT-free survival rate was 93.7% in paroxysmal AF patients, and 81.1% in persistent AF patients. CONCLUSIONS: A novel continuous automatic laser balloon ablation system was proved to be safe and effective for both paroxysmal and persistent AF patients. The clinical result demonstrated that PV isolation with X3 could achieve a high SVT-free survival rate.
