Background: The tissue selectivity of pulsed field ablation (PFA) provides safety advantages over radiofrequency ablation in treating atrial fibrillation. One-shot PFA catheters have been shown capable of performing pulmonary vein isolation, but not flexible lesion sets such as linear lesions. A novel lattice-tip ablation catheter with a compressible 9-mm nitinol tip is able to deliver either focal radiofrequency ablation or PFA lesions, each in 2 to 5 s. Methods: In a 3-center, single-arm, first-in-human trial, the 7.5F lattice catheter was used with a custom mapping system to treat paroxysmal or persistent atrial fibrillation. Toggling between energy sources, point-by-point pulmonary vein encirclement was performed using biphasic PFA posteriorly and either temperature-controlled irrigated radiofrequency ablation or PFA anteriorly (RF/PF or PF/PF, respectively). Linear lesions were created using either PFA or radiofrequency ablation. Results: The 76-patient cohort included 55 paroxysmal and 21 persistent atrial fibrillation patients undergoing either RF/PF (40 patients) or PF/PF (36 patients) ablation. The pulmonary vein isolation therapy duration time (transpiring from first to last lesion) was 22.6±8.3 min/patient, with a mean of 50.1 RF/PF lesions/patient. Linear lesions included 14 mitral (4 RF/2 RF+PF/8 PF), 34 left atrium roof (12 RF/22 PF), and 44 cavotricuspid isthmus (36 RF/8 PF) lines, with therapy duration times of 5.1±3.5, 1.8±2.3, and 2.4±2.1 min/patient, respectively. All lesion sets were acutely successful, using 4.7±3.5 minutes of fluoroscopy. There were no device-related complications, including no strokes. Postprocedure esophagogastroduodenoscopy revealed minor mucosal thermal injury in 2 of 36 RF/PF and 0 of 24 PF/PF patients. Postprocedure brain magnetic resonance imaging revealed diffusion-weighted imaging+/fluid-attenuated inversion recovery- and diffusion-weighted imaging+/fluid-attenuated inversion recovery+ asymptomatic lesions in 5 and 3 of 51 patients, respectively. Conclusions: A novel lattice-tip catheter could safely and rapidly ablate atrial fibrillation using either a combined RF/PF approach (capitalizing on the safety of PFA and the years of experience with radiofrequency energy) or an entirely PF approach. Registration: URL: https://www.clinicaltrials.gov ; Unique identifiers: NCT04141007 and NCT04194307.

Background: In prior unblinded studies, cardiac neuromodulation therapy (CNT) employing a sequence of variably timed short and longer atrioventricular intervals yielded sustained reductions of systolic blood pressure (SBP) in patients with hypertension. The effects of CNT on SBP were investigated in this double‐blind randomized pilot study. Methods and Results: Eligible patients had daytime ambulatory SBP (aSBP) ≥130 mm Hg and office SBP ≥140 mm Hg despite taking ≥1 antihypertensive medication, and an indication for a dual‐chamber pacemaker. Patients underwent Moderato device implantation, which was programmed as a standard pacemaker during a 1‐month run‐in phase. Patients whose daytime aSBP was ≥125 mm Hg at the end of this period were randomized (1:1, double blind) to treatment (CNT) or control (CNT inactive). The primary efficacy end point was the between‐group difference of the change in 24‐hour aSBP at 6 months. Of 68 patients initially enrolled and who underwent implantation with the Moderato system, 47 met criteria for study continuation and were randomized (26 treatment, 21 control). The mean age was 74.0±8.7 years, 64% were men, left ventricular ejection fraction was 59.2%±5.7%, and aSBP averaged 141.0±10.8 mm Hg despite the use of 3.3±1.5 antihypertensive medications; 81% had isolated systolic hypertension. Six months after randomization, aSBP was 11.1±10.5 mm Hg (95% CI, −15.2 to −8.1 mm Hg) lower than prerandomization in the treatment group compared with 3.1±9.5 mm Hg (−7.4 to 1.2 mm Hg) lower in controls, yielding a net treatment effect of 8.1±10.1 mm Hg (−14.2 to −1.9 mm Hg) ( P =0.012). There were no Moderato device– or CNT‐related adverse events. Conclusions: CNT significantly reduced 24‐hour aSBP in patients with hypertension with a clinical indication for a pacemaker. The majority of patients had isolated systolic hypertension, a particularly difficult group of patients to treat. Registration: URL: https://www.clinicaltrials.gov ; Unique identifier: NCT02837445.

This study was designed to evaluate lesion durability on invasive electrophysiologic remapping. The lattice-tip catheter generates a large thermal footprint during temperature-controlled irrigated radiofrequency ablation. In a first-in-human study, this catheter performed rapid point-by-point pulmonary vein isolation (PVI) and other linear atrial ablations. In a prospective 3-center single-arm study, paroxysmal or persistent atrial fibrillation patients underwent PVI and, as needed, linear ablation at the cavotricuspid isthmus (CTI), mitral isthmus (MI), and/or left atrial roof; no other atrial substrate was ablated. Using the lattice catheter and a custom electroanatomic mapping system, temperature-controlled (Tmax 73° to 80°C; 2 to 7 s) point-by-point ablation was performed. Patients were followed for 12 months. A total of 65 patients (61.5% paroxysmal/38.5% persistent) underwent ablation: PVI in 65, MI in 22, left atrial roof in 24, and CTI in 48 patients. At a median of 108 days after the index procedure, protocol-mandated remapping was performed in 27 patients. The pulmonary veins (PVs) remained durably isolated in all but 1 reconnected PV-translating to durable isolation in 99.1% of PVs, or 96.3% of patients with all PVs isolated. Of 47 linear atrial lesions initially placed during the index procedure, durability was observed in 10 of 11 (90.9%) MI lines, all 11 (100%) roof lines, and all 25 (100%) CTI lines. After a median follow-up of 270 days, the 12-month Kaplan-Meier estimate for freedom from atrial arrhythmias was 94.4 ± 3.2%. Temperature-controlled lattice-tip point-by-point ablation showed not only highly durable PVI lesion sets, but also durable contiguity of linear atrial lesions.

The aim of our study was to investigate the reliability of automated oscillometric blood pressure (BP) monitoring in the presence and absence of atrial fibrillation (AF) in hypertensive patients. BP was measured and compared in 71 randomly selected patients with AF and arterial hypertension diagnosis, 4 times each by auscultatory and oscillometric (Microlife BP A6 PC with AF detection system) methods. Study included 71 patients: 36 males (mean age 67.4 years) and 35 females (70.2 years). At the time of BP measuring procedure, 36 patients were in sinus rhythm (SR) and 35 in AF. In SR patients mean systolic blood pressure (SBP) was 132 ± 17.9 mmHg with auscultatory method (AM), 137.4 ± 19.4 mmHg with oscillometric method (OM); mean diastolic BP was 77.1 ± 10.9 mmHg (AM), 78.5 ± 12.2 mmHg (OM), in AF patients mean SBP was 127.5 ± 15.1 mmHg (AM), 133.6 ± 17.4 mmHg (OM); mean diastolic BP was 81.4 ± 9.9 mmHg (AM), 83.5 ± 11.8 mmHg (OM), p = 0.037. The averages of differences for SBP and DBP in sinus rhythm group were (−5.3 mmHg (95% limits of agreement −27.2 – 16.6)) and (−1.4 mmHg (95% limits of agreement −12.8 – 10.0)), respectively. In patients with AF the averages of differences for SBP and DBP were (−6.1 mmHg (95% limits of agreement −23.9 – 11.7)) and (−2.1 mmHg (95% limits of agreement −12.9 – 8.7)), respectively. The oscillometric device validated for patients with AF on average gives 5.3 mmHg higher systolic BP values for patients with SR and 6.3 mmHg higher BP values for patients with AF. However, the limits of agreement between two methods reveal wide range of random error rates which is a questionable topic in clinical practice, as it could possibly affect the treatment of arterial hypertension in patients with AF.

To evaluate a diagnostic value of transoesophageal echocardiogram (TEE) in appropriately anticoagulated patients with a non-valvular atrial fibrillation (AF) and to establish possible additional indications for TEE; to evaluate the incidence of left atrial (LA) thrombi in appropriately anticoagulated patients in daily clinical practice. This retrospective study analyses data of 432 patients who had been anticoagulated by means of oral anticoagulants (OACs) prior to planned cardioversion during the period from 2012 to 2015. Thromboembolic (TE) and bleeding risks were assessed using CHA2DS2-VASc and HAS-BLED scores. Transthoracic and transoesophageal echocardiograms were evaluated. TE complications during 30 days after discharge were assessed. 432 patients were selected, aged from 22 to 89 years (mean 65.0 ±11.5), 277 (64.1%) males and 155 (35.9%) females, 306 (70.8%) on warfarin and 126 (29.2%) on non-vitamin K antagonist oral anticoagulants (NOAC). Mean CHA2DS2-VASc score was 3.5 ±1.5. TEE was performed for 120 (27.8%) patients, more frequently for patients on NOACs and for ones with III° LA enlargement. TEE revealed LA thrombi in seven (5.8%) of the patients. In warfarin and NOACs groups thrombi were revealed in five (7.0%) and two (4.1%) patients, respectively. TEE did not reveal any thrombi in patients with normal left ventricular (LV) function; however, thrombi were found in two (6.1%) patients with slightly decreased LV function, and in five (17.9%) patients with markedly decreased LV function. In patients with decreased left ventricular ejection fraction (LVEF) thrombi in LA were found more frequently than in patients with normal and slightly decreased LVEF (17.9% vs 2.2%, p=0.008). CHA2DS2-VASc score of all 7 patients was ≥5. None of the patients after cardioversion had TE complications 30 days after discharge. The risk of LA thrombi in patients prepared for scheduled cardioversion in line with the guidelines is low. Higher risk of thrombi was present in patients with decreased LVEF (≤40%), CHA2DS2-VASc ≥5. In order to assess more accurately indications to perform TEE for appropriately anticoagulated patients prior to scheduled cardioversion a study with larger number of patients is required.

Atrial fibrillation (AF) is the most common supraventricular arrhythmia, affecting 2–3% of the adult population, with an increasing prevalence due to demographic shifts; however, detection methods have also improved. This rhythm disorder is associated with significant morbidity, manifesting through symptoms that worsen the quality of life, as well as with adverse outcomes and increased mortality. The substantial AF burden on the healthcare system necessitates the development of effective and durable treatment strategies. While pharmacological management represents the first-line approach for AF, the limitations associated with this approach, including side effects and insufficient efficacy, have promoted the evolution of catheter ablation techniques that isolate pulmonary veins (PVs) and, thus, disrupt arrhythmia-causing impulses from the atria. Currently, three energy sources have gained U.S. Food and Drug Administration (FDA) and European regulatory approval (The Conformité Européene (CE) mark certification) for catheter ablation: radiofrequency ablation (RFA), cryoballoon ablation (CBA), and, more recently, pulsed-field ablation (PFA). RFA has subsequently become an effective treatment, demonstrating superior outcomes in randomized controlled trials compared to antiarrhythmic drug therapy. CBA has also proven to be a safe and effective alternative, particularly for patients with symptomatic paroxysmal AF, showing comparable efficacy to RFA and similar rates of complications. Meanwhile, PFA is emerging as a promising technique, offering non-inferior efficacy to conventional thermal methods while potentially minimizing the thermal damage to adjacent tissues associated with RFA and CBA. Despite higher equipment costs, the advantages of PFA in reducing complications highlight its potential role in AF management. However, considering the novelty of PFA, no data currently exist comparing this strategy with thermal techniques. Therefore, further research is needed to improve the management of AF and patient outcomes to reduce healthcare burdens.