Pulsed Field Versus Cryoballoon Pulmonary Vein Isolation for Atrial Fibrillation: Efficacy, Safety, and Long-Term Follow-Up in a 400-Patient Cohort.

BACKGROUND: The cryoballoon (CB) represents the gold standard single-shot device for pulmonary vein isolation (PVI) in patients with atrial fibrillation (AF). Single-shot pulsed field PVI ablation (nonthermal, cardiac tissue selective) has recently entered the arena. We sought to compare procedural data and long-term outcome of both techniques. METHODS: Consecutive AF patients who underwent pulsed field ablation (PFA) and CB-based PVI were enrolled. CB PVI was performed using the second-generation 28-mm CB; PFA was performed using a 31/35-mm pentaspline catheter. Success was defined as freedom from atrial tachyarrhythmia after a 3-month blanking period. RESULTS: Four hundred patients were included (56.5% men; 60.8% paroxysmal AF; age 70 [interquartile range, 59-77] years), 200 in each group (CB and PFA), and baseline characteristics did not differ. Acute PVI was achieved in 100% of PFA and in 98% (196/200) of CB patients (P=0.123; 4 touch-up ablations). Median procedure time was significantly shorter in PFA (34.5 [29-40] minutes) versus CB (50 [45-60] minutes; P<0.001), fluoroscopy time was similar. Overall procedural complications were 6.5% in CB and 3.0% in PFA (P=0.1), driven by a higher rate of phrenic nerve palsies using CB. The 1-year success rates in paroxysmal AF (CB, 83.1%; PFA, 80.3%; P=0.724) and persistent AF (CB, 71%; PFA, 66.8%; P=0.629) were similar for both techniques. CONCLUSIONS: PFA compared with CB PVI shows a similar procedural efficacy but is associated with shorter procedure time and no phrenic nerve palsies. Importantly, 12-month clinical success rates are favorable but not different between both groups.

Catheter ablation induced phrenic nerve palsy by pulsed field ablation-completely impossible? A case series.

Background: Pulsed field ablation (PFA) is a new feasible and safe method for the ablative treatment of cardiac arrhythmias, such as atrial fibrillation (AF). Through the use of electric fields, it causes pore-like openings in the cell's wall, leading to cell death. The most appealing characteristic of this new technique is its selectivity for cardiomyocytes and consequently its low risk of collateral damage to extracardiac tissues. We present three cases of a PFA-induced transient phrenic nerve (PN) injury documented during pulmonary vein isolation (PVI). Case summaries: Three patients aged 55-81 years underwent PFA for symptomatic AF. Cases 1 and 3 were affected by paroxysmal AF without evidence of structural heart disease. Case 2 had persistent AF and ischaemic cardiomyopathy with preserved ejection fraction. We observed a transient right hemidiaphragm palsy during the delivery of impulses in the right superior pulmonary vein (Cases 1 and 2) and in the right inferior pulmonary vein (Case 3). The palsy lasted <1 min and was followed by spontaneous full recovery in all cases. Discussion: Transient PN dysfunction can be observed following PFA in AF ablation. According to our initial experience, a full recovery of the PN function can be expected within seconds. We hypothesize a hyperpolarization of neuronal cells or a depletion of acetylcholine in the motoric endplate to explain this event. Further studies are required to understand the exact pathophysiological mechanism.

5S Study: Safe and Simple Single Shot Pulmonary Vein Isolation With Pulsed Field Ablation Using Sedation.

BACKGROUND: Pulsed field ablation represents an energy source specific for ablation of cardiac arrhythmias including atrial fibrillation. The aim of the study was to describe the adoption and the process of streamlining procedures with a new ablation technology. METHODS: All-comer atrial fibrillation patients (n=191; mean age 69±12 years) underwent catheter ablation with a pulsed field ablation ablation device exclusively using analog-sedation. In the validation phase (n=25), device electrogram quality was compared with a circular mapping catheter to assess pulmonary vein isolation and esophageal temperature monitoring was used. In the streamline phase (n=166), a single-catheter approach was implemented. Postprocedural cerebral magnetic resonance imaging was performed in 53 patients. In 52 patients, esophageal endoscopy was performed at day 1 after the procedure. Follow-up was performed using 72 hours Holter ECGs. RESULTS: On a pulmonary vein basis, pulmonary vein isolation rate was 100% including a single shot isolation rate of 99.5%. The electrogram information of the pulsed field ablation catheter and the circular mapping catheter were 100% congruent. Neither esophageal temperature rises nor esophageal thermal injury were observed. Two minor strokes occurred, presumable due to air embolism during catheter exchanges through the large bore sheath (13.8 F ID). In the streamline phase, reduced procedure times (46±14 versus 38±13 minutes, P=0.004), no further strokes and a low incidence of silent cerebral injury (10/53 patients; 19%) were noted. During short-term follow-up, 17/191 patients (9%) had a atrial tachyarrhythmia recurrence. CONCLUSIONS: The pulsed field ablation device allows for simple and safe simple single shot pulmonary vein isolation using standard sedation protocols. Procedural speed and efficacy are remarkable and streamlining measures have added safety.

Pulsed Field Ablation for Persistent Superior Vena Cava: New Solution for an Old Problem.

Persistent left superior vena cava (PLSVC) is a known arrhythmogenesis site in patients with atrial fibrillation. However, the optimal PLSVC isolation approach has remained unclear because of the potential risk of complications. The current study reports 2 cases of successful electrical PLSVC isolation using pulsed field ablation. (Level of Difficulty: Intermediate.).

Vascular Aging and Disease of the Large Vessels: Role of Inflammation.

Structural and functional arterial properties commonly impair with aging process. These effects on vasculature could act at many levels from microcirculation to large vessels. Above normal aging process classic cardio-vascular risk factors (hypertension, diabetes mellitus, dyslipidemia, etc.) accelerate the physiological process leading to premature structural and functional alterations that has also been termed early vascular aging. Target organ damage evaluation could be clinically important since these alterations precede by many years' cardiovascular events and so their assessment can predict the onset of more serious and costly events giving the opportunity to prevent CV events by earlier therapeutic intervention. This review will focus on large artery functional properties and particularly on the role of inflammation on the aortic stiffening process.

In healthy normotensive subjects age and blood pressure better predict subclinical vascular and cardiac organ damage than atherosclerosis biomarkers.

PURPOSE: Only few studies evaluated biomarkers useful for defining the cardiovascular risk of a subject in a pre-clinical condition (i.e. healthy subjects). In this context we sought to determine the relationships of Plasminogen activator inhibitor type 1 (PAI-1), P-Selectin, Tissue Inhibitors Metalloproteinases type 1 (TIMP-1) and Cystatin-C with subclinical Target Organ Damage (TOD) in normotensive and normoglycemic subjects without known cardiovascular and kidney diseases. MATERIALS AND METHODS: 480 blood donors participated at the present analysis. TOD was evaluated as Pulse Wave Velocity (PWV), Left Ventricular Hypertrophy (LVH) and Intima Media Thickness (IMT) and carotid plaque presence) grouped together under carotid TOD. RESULTS: 3.1% of the subjects showed a PWV higher than 10 m/sec with those subjects exerting significantly lower values of P-Selectine (0.068 ± 0.015 vs 0.08 ± 0.036 mg/L, p = .014). 8.8% of the subjects showed carotid TOD that was associated with higher Cystatin-C values (0.67 ± 0.17 vs 0.63 ± 0.14 mg/L, p = .045). Finally 23.8% of the subjects showed LVH with no significant differences regarding biomarkers. Despite some significant correlations between biomarkers and TOD, at the multivariate analysis none came out to be as significant predictor of the assessed TOD. CONCLUSIONS: in normotensive and normoglycemic healthy subjects, the evaluated biomarkers of atherosclerotic process didn't show any significant association with cardiac, carotid and vascular TOD while age and BP are its principal predictors.