BACKGROUND: Preclinical studies of pulsed field ablation (PFA) have demonstrated an absence of esophageal lesions. However, esophageal assessments are typically performed weeks after PFA, precluding an understanding of acute effects. OBJECTIVES: To understand the mechanism of esophageal safety with PFA, using preclinical and clinical assessments. METHODS: In 6 swine (early, n=4; late, n=2) under anesthesia and paralysis, the esophagus was manually displaced toward the inferior vena cava (IVC) using a balloon catheter. From the IVC, a pentaspline PFA catheter delivered 4 stacked applications at 4-7 sites. Animals were sacrificed either early (1 day) or late (14 days), followed by pathological assessment. PFA's mechanical effect on the esophagus was determined in other preclinical and clinical studies (with or without paralytics) by contrast fluoroscopy during left atrial PFA. RESULTS: After 1 day, 3 of 4 animals demonstrated esophageal lesions, measuring 13.3±8.5 mm long, 6.3±5.9 mm wide, and 2.3±0.6 mm deep. All lesions were non-transmural, with myocyte degeneration and leucocyte infiltration on histology; the mucosa and blood vessels were spared. Conversely, the 14-day cohort exhibited no lesions upon gross necropsy or histology. During atrial PFA using various catheters, waveforms and manufacturers, esophageal contraction universally occurred such that it functionally retracted away from the point of ablation. CONCLUSIONS: The pentaspline PFA catheter creates acute non-transmural esophageal lesions that resolve by 14 days. The "functional sparing" of the esophagus during PFA is not due to absolute esophageal sparing, but rather to a combination of favorable tissue healing and, likely, some degree of esophageal contraction/retraction.

• Klíčová slova
• catheter ablation, electroporation, esophagus, preclinical, pulsed field ablation,
• Publikační typ
• časopisecké články 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.

• Klíčová slova
• Atrial fibrillation, Catheter ablation, Pulmonary vein isolation, Pulsed field ablation, Spherical array catheter,
• 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
• klinické zkoušky MeSH
• práce podpořená grantem MeSH

AIMS: Wearable cardioverter-defibrillators (WCDs) are indicated in patients at risk of sudden cardiac arrest who are not immediate candidates for implantable defibrillator therapy. Limitations of existing WCDs include poor compliance and high false alarm rates. The Jewel is a novel patch-WCD (P-WCD) that addresses these limitations with an adhesive-based design for near-continuous wear and a machine learning algorithm designed to minimize inappropriate detections. This was a first-in-human study of the Jewel P-WCD conducted in an electrophysiology (EP) lab to determine the safety and effectiveness of the device in terminating ventricular tachycardia/ventricular fibrillation (VT/VF) with a single shock. The aim was to evaluate the safety and effectiveness of terminating VT/VF with a single shock using the Jewel P-WCD. METHODS AND RESULTS: This was a first-in-human, prospective, single-arm, single-centre study in patients scheduled for an EP procedure in which VT/VF was expected to either spontaneously occur or be induced. The Jewel P-WCD was placed on consented patients; upon confirmation of VT/VF, a single shock (150 J) was delivered via the device. A group sequential design and Pocock alpha spending function was used to measure the observed proportion of successful VT/VF single-shock terminations. The endpoint was achieved if the lower confidence limit exceeded the performance goal of 62%, using a one-sided lower 97.4% exact confidence bound. Of 18 eligible subjects, 16 (88.9%, 97.4% confidence bound: 65.4%) were successfully defibrillated with a single shock, exceeding the primary endpoint performance goal with no adverse events. CONCLUSION: This first-in-human evaluation of the Jewel P-WCD demonstrated the safety and effectiveness of terminating VT/VF. CLINICAL TRIAL REGISTRATION: URL: https://clinicaltrials.gov/; Unique identifier: NCT05490459.

• Klíčová slova
• Sudden cardiac arrest, Ventricular arrhythmia, Wearable cardioverter-defibrillator,
• MeSH
• defibrilátory * MeSH
• design vybavení MeSH
• dospělí MeSH
• elektrická defibrilace * přístrojové vybavení   škodlivé účinky   MeSH
• fibrilace komor * terapie   diagnóza   MeSH
• komorová tachykardie * terapie   diagnóza   patofyziologie   MeSH
• lidé středního věku MeSH
• lidé MeSH
• náhlá srdeční smrt prevence a kontrola   MeSH
• nositelná elektronika * MeSH
• prospektivní studie 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
• klinická studie MeSH

• Klíčová slova
• atrial fibrillation, catheter, catheter ablation, electroporation, hemoglobin, hemolysis,
• MeSH
• hemolýza * MeSH
• katetrizační ablace * škodlivé účinky   MeSH
• lidé MeSH
• srdeční katétry MeSH
• výsledek terapie MeSH
• zvířata MeSH
• Check Tag
• lidé MeSH
• zvířata MeSH
• Publikační typ
• dopisy MeSH

BACKGROUND: Preclinical studies have revealed that pulsed field ablation (PFA) lesion dimensions increase with repetitive applications at a similar electric field. OBJECTIVES: This study investigated whether pulmonary vein isolation (PVI) durability varies with single vs repetitive pulsed field (PF) applications. METHODS: Atrial fibrillation patients underwent PVI using a spherical multielectrode array PFA catheter delivered with a 19-F deflectable sheath under intracardiac echocardiographic guidance. Esophagogastroduodenoscopy and brain magnetic resonance imaging were performed within 1 to 3 days, and invasive remapping at ∼2 to 3 months. RESULTS: The patient cohort (n = 21; age 63 ± 11 years; 67% women) underwent PVI in either of 2 groups: group 1 (n = 11)-single PF application/PV; and group 2 (n = 10)-3 PF applications/PV. In both groups, PVI was acutely successful in all (100%) patients. Despite significantly longer pulse delivery times (75.2 ± 7.4 s/patient vs 24.5 ± 5.5 s/patient) the procedure times (73.2 ± 13.7 minutes vs 93.7 ± 18.5 minutes) were shorter with group 2 vs group 1. There was no stroke/transient ischemic attack, pericardial effusion, phrenic nerve injury, or esophageal complications. Esophagogastroduodenoscopy was normal in both groups of patients (n = 9). Screening brain magnetic resonance imaging revealed asymptomatic cerebral lesions (diffusion weighted imaging+/fluid attenuated inversion recovery-) in 3 of 16 (18.7%) patients. PV remapping revealed durable PVI in 62.5% PVs in group 1 (n = 10), compared with all 100% PVs in group 2 (n = 9); this translates to all PVs being durably isolated in 30% vs 100% (P < 0.05) of patients in groups 1 and 2, respectively. CONCLUSIONS: In his first-in-human trial, the "single-shot" spherical array PFA catheter was shown to safely isolate PVs. Repetitive PF application is key for lesion consolidation to maximize PVI durability.

• Klíčová slova
• atrial fibrillation, catheter ablation, pulmonary vein isolation, pulse field ablation,
• MeSH
• časové faktory MeSH
• katetrizační ablace * metody   MeSH
• katétry MeSH
• lidé středního věku MeSH
• lidé MeSH
• senioři MeSH
• srdeční frekvence 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

BACKGROUND: During atrial fibrillation ablations using thermal energy, the treatment effect is attributed to not just pulmonary vein isolation (PVI), but also to modulation of the autonomic nervous system by ablation of cardiac ganglionated plexi (GP). OBJECTIVES: This study sought to assess the impact of pulsed field ablation (PFA) on the GP in patients undergoing PVI. METHODS: In the retrospective phase, heart rate was assessed pre- versus post-PVI using PFA, cryoballoon ablation, or radiofrequency ablation. In the prospective phase, a pentaspline PFA catheter was used in a protocol: 1) pre-PFA, high-frequency stimulation (HFS) identified GP sites by vagal effects; 2) PVI was performed assessing for repetitive vagal effects over each set of PF applications; 3) mapping defined PVI extent to identify those GP in the ablation zone; and 4) repeat HFS at GP sites to assess for persistence of vagal effects. RESULTS: Between baseline and 3 months, heart rates in the retrospective radiofrequency ablation (n = 40), cryoballoon (n = 40), and PFA (n = 40) cohorts increased by 8.9 ± 11.4, 11.1 ± 9.4, and -0.1 ± 9.2 beats/min, respectively (P= 0.01 PFA vs radiofrequency ablation; P= 0.01 PFA vs cryoballoon ablation). In the prospective phase, pre-PFA HFS in 20 additional patients identified 65 GP sites. During PFA, vagal effects were noted in 45% of first PF applications, persisting through all applications in 83%. HFS post-PFA reproduced vagal effects in 29 of 38 sites (76%) in low-voltage tissue. CONCLUSIONS: PFA has minimal effect on GP. Unlike with thermal ablation, the mechanism by which PFA treats atrial fibrillation is mediated solely by durable PVI.

• Klíčová slova
• atrial fibrillation, cardiac autonomic nervous system, pulsed field ablation,
• MeSH
• fibrilace síní * MeSH
• katetrizační ablace * škodlivé účinky   MeSH
• lidé MeSH
• nervus vagus chirurgie   MeSH
• prospektivní studie MeSH
• retrospektivní studie MeSH
• Check Tag
• lidé MeSH
• Publikační typ
• časopisecké články MeSH

BACKGROUND: Pulsed field ablation (PFA) has a unique safety profile when used to treat atrial fibrillation, largely related to its preferentiality for myocardial tissue ablation, in particular, esophageal sparing. A pentaspline catheter was the first such PFA system studied clinically for atrial fibrillation ablation; in these initial regulatory trials, the catheter was used for pulmonary vein isolation and left atrial posterior wall ablation. Since its regulatory approval in Europe, in clinical practice, physicians have ablated beyond pulmonary vein isolation and left atrial posterior wall ablation to expanded lesion sets in closer proximity to coronary arteries. This is an unstudied important issue because preclinical and clinical data have raised the potential for coronary arterial spasm. Herein, we studied the vasospastic potential of PFA lesion sets, both remote from and adjacent to coronary arteries. METHODS: During routine atrial fibrillation ablation using the pentaspline PFA catheter, coronary angiography was performed before, during, and after pulsed field applications. The lesion sets studied included: (1) those remote from the coronary arteries such as pulmonary vein isolation (n=25 patients) and left atrial posterior wall ablation (n=5), and (2) ablation of the cavotricuspid isthmus (n=20) that is situated adjacent to the right coronary artery. RESULTS: During pulmonary vein isolation and left atrial posterior wall ablation, coronary spasm did not occur, but cavotricuspid isthmus ablation provoked severe subtotal vasospasm in 5 of 5 (100%) consecutive patients, and this was relieved by intracoronary nitroglycerin in 5.5±3.5 minutes. ST-segment elevation was not observed. However, no patient (0%, P=0.004) had severe spasm if first administered parenteral nitroglycerin, either intracoronary (n=5) or intravenous (n=10), before treatment. CONCLUSIONS: Coronary vasospasm was not provoked during PFA at locations remote from coronary arteries, but when the energy is delivered adjacent to a coronary artery, PFA routinely provokes subclinical vasospasm. This phenomenon is attenuated by nitroglycerin, administered either post hoc to treat spasm or as prophylaxis.

• Klíčová slova
• ablation techniques, atrial fibrillation, coronary vasospasm, electroporation,
• MeSH
• fibrilace síní * chirurgie   MeSH
• katetrizační ablace * škodlivé účinky   MeSH
• koronární cévy diagnostické zobrazování   chirurgie   MeSH
• lidé MeSH
• nitroglycerin terapeutické užití   MeSH
• srdeční síně MeSH
• venae pulmonales * MeSH
• výsledek terapie MeSH
• Check Tag
• lidé MeSH
• Publikační typ
• časopisecké články MeSH
• Názvy látek
• nitroglycerin MeSH

BACKGROUND: Catheter ablation for atrial fibrillation (AF) using point-by-point radiofrequency energy or single-application one-shot balloons is either technically challenging or have limited ability to accommodate variable patient anatomy to achieve acute and durable pulmonary vein (PV) isolation. A novel ablation system employs low intensity collimated ultrasound (LICU)-guided anatomic mapping and robotic ablation to isolate PVs. In this first-in-human, single-center, multioperator trial, VALUE trial (VytronUS Ablation System for Treatment of Paroxysmal Atrial Fibrillation; NCT03639597) in patients with paroxysmal atrial fibrillation, this LICU system was evaluated to determine its safety, effectiveness in PV isolation, and freedom from recurrent atrial arrhythmias. METHODS: In the enrolled 52 patients with paroxysmal atrial fibrillation, ultrasound M-mode-based left atrial anatomies were successfully created, and ablation was performed under robotic control along an operator-defined lesion path. The LICU system software advanced over the course of the study: the last 13 patients were ablated with enhanced software. RESULTS: Acute PV isolation was achieved in 98% of PVs-using LICU-only in 77.3% (153/198) of PVs and requiring touch-up with a standard radiofrequency ablation catheter in 22.7% (45/198) PVs. The touch-up rate decreased to 5.8% (3/52) in patients undergoing LICU-ablation with enhanced software. Freedom from atrial arrhythmia recurrence was 79.6% (39/49 patients) at 12 months or 92.3% (12/13 patients) with the enhanced software. Major adverse events occurred in 3 patients (5.8%): one had transient diaphragmatic paralysis, one vascular access complication, and one had transient ST-segment elevation from air-embolism, without sequelae. CONCLUSIONS: In this first-in-human study, low- intensity collimated ultrasound-guided anatomic mapping and robotic ablation allows PV isolation with good chronic safety; PV isolation success is improving with device enhancements. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT03639597.

• Klíčová slova
• atrial fibrillation, catheter, catheter ablation, pulmonary veins, software,
• MeSH
• chirurgie s pomocí počítače metody   MeSH
• design vybavení MeSH
• dospělí MeSH
• fibrilace síní diagnóza   patofyziologie   chirurgie   MeSH
• katetrizační ablace přístrojové vybavení   MeSH
• lidé středního věku MeSH
• lidé MeSH
• mladiství MeSH
• mladý dospělý MeSH
• následné studie MeSH
• převodní systém srdeční diagnostické zobrazování   patofyziologie   MeSH
• prospektivní studie MeSH
• recidiva MeSH
• senioři MeSH
• ultrasonografie přístrojové vybavení   MeSH
• venae pulmonales diagnostické zobrazování   chirurgie   MeSH
• výsledek terapie MeSH
• Check Tag
• dospělí MeSH
• lidé středního věku MeSH
• lidé MeSH
• mladiství MeSH
• mladý dospělý MeSH
• mužské pohlaví MeSH
• senioři MeSH
• ženské pohlaví MeSH
• Publikační typ
• časopisecké články MeSH
• klinická studie MeSH
• práce podpořená grantem MeSH

OBJECTIVES: The authors report the first acute clinical experience of atrial fibrillation ablation with PEF-both epicardial box lesions during cardiac surgery, and catheter-based PV isolation. BACKGROUND: Standard energy sources rely on time-dependent conductive heating/cooling and ablate all tissue types indiscriminately. Pulsed electric field (PEF) energy ablates nonthermally by creating nanoscale pores in cell membranes. Potential advantages for atrial fibrillation ablation include: 1) cardiomyocytes have among the lowest sensitivity of any tissue to PEF-allowing tissue selectivity, thereby minimizing ablation of nontarget collateral tissue; 2) PEF is delivered rapidly over a few seconds; and 3) the absence of coagulative necrosis obviates the risk of pulmonary vein (PV) stenosis. METHODS: PEF ablation was performed using a custom over-the-wire endocardial catheter for percutaneous transseptal PV isolation, and a linear catheter for encircling the PVs and posterior left atrium during concomitant cardiac surgery. Endocardial voltage maps were created pre- and post-ablation. Continuous and categorical data are summarized and presented as mean ± SD and frequencies. RESULTS: At 2 centers, 22 patients underwent ablation under general anesthesia: 15 endocardial and 7 epicardial. Catheter PV isolation was successful in all 57 PVs in 15 patients (100%) using 3.26 ± 0.5 lesions/PV: procedure time 67 ± 10.5 min, catheter time (PEF catheter entry to exit) 19 ± 2.5 min, total PEF energy delivery time <60 s/patient, and fluoroscopy time 12 ± 4.0 min. Surgical box lesions were successful in 6 of 7 patients (86%) using 2 lesions/patient. The catheter time for epicardial ablation was 50.7 ± 19.5 min. There were no complications. CONCLUSIONS: These data usher in a new era of tissue-specific, ultrarapid ablation of atrial fibrillation.

• Klíčová slova
• atrial fibrillation, catheter ablation, electroporation, pulmonary vein isolation, pulsed electric field,
• MeSH
• délka operace MeSH
• elektroporace metody   MeSH
• endokard chirurgie   MeSH
• fibrilace síní chirurgie   MeSH
• katetrizační ablace metody   MeSH
• lidé středního věku MeSH
• lidé MeSH
• perikard chirurgie   MeSH
• prospektivní studie MeSH
• senioři MeSH
• venae pulmonales chirurgie   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

BACKGROUND: Saline irrigation improved the safety of radiofrequency (RF) ablation, but the thermal feedback for energy titration is absent. OBJECTIVES: To allow temperature-controlled irrigated ablation, a novel irrigated RF catheter was designed with a diamond-embedded tip (for rapid cooling) and 6 surface thermocouples to reflect tissue temperature. High-resolution electrograms (EGMs) from the split-tip electrode allowed rapid lesion assessment. The authors evaluated the preclinical and clinical performance of this catheter for pulmonary vein (PV) isolation. METHODS: Using the DiamondTemp (DT) catheter, pigs (n = 6) underwent discrete atrial ablation in a temperature control mode (60°C/50 W) until there was ∼80% EGM amplitude reduction. In a single-center clinical feasibility study, 35 patients underwent PV isolation with the DT catheter (study group); patients were planned for PV remapping after 3 months, regardless of symptomatology. A control group included 35 patients who underwent PV isolation with a standard force-sensing catheter. RESULTS: Porcine lesion histology revealed transmurality in 51 of 55 lesions (92.7%). In patients, all PVs were successfully isolated; no char or thrombus formation was observed. Compared with the control group, the study cohort had shorter mean RF application duration (26.3 ± 5.2 min vs. 89.2 ± 27.2 min; p < 0.001), shorter mean fluoroscopic time (11.2 ± 8.5 min vs. 19.5 ± 6.8 min; p < 0.001), and lower acute dormant PV reconduction (0 of 35 vs. 5 of 35; p = 0.024). At 3 months, 23 patients underwent remapping: 39 of 46 PV pairs (84.8%) remained durably isolated in 17 of these patients (73.9%). CONCLUSIONS: This first-in-human series demonstrated that temperature-controlled irrigated ablation produced rapid, efficient, and durable PV isolation. (ACT DiamondTemp Temperature-Controlled and Contact Sensing RF Ablation Clinical Trial for Atrial Fibrillation [TRAC-AF]; NCT02821351).

• Klíčová slova
• catheter ablation, electrogram, first-in-human, histology, remapping,
• MeSH
• časové faktory MeSH
• design vybavení MeSH
• dospělí MeSH
• elektrokardiografie MeSH
• fibrilace síní patofyziologie   chirurgie   MeSH
• katetrizační ablace přístrojové vybavení   MeSH
• lidé středního věku MeSH
• lidé MeSH
• mladiství MeSH
• mladý dospělý MeSH
• následné studie MeSH
• prasata MeSH
• převodní systém srdeční patofyziologie   chirurgie   MeSH
• prospektivní studie MeSH
• senioři MeSH
• teplota MeSH
• venae pulmonales chirurgie   MeSH
• výsledek terapie MeSH
• zvířata MeSH
• Check Tag
• dospělí MeSH
• lidé středního věku MeSH
• lidé MeSH
• mladiství MeSH
• mladý dospělý MeSH
• mužské pohlaví MeSH
• senioři MeSH
• ženské pohlaví MeSH
• zvířata MeSH
• Publikační typ
• časopisecké články MeSH
• klinické zkoušky MeSH