Contact force (CF)-sensing radiofrequency (RF) catheters with an ablation index have shown reproducible outcomes for the treatment of atrial fibrillation (AF) in large multicentre studies. A ...dual-energy (DE) focal CF catheter to deliver RF and unipolar/biphasic pulsed field ablation (PFA), integrated with a three-dimensional (3D) mapping system, can provide operators with additional flexibility. The SmartfIRE study assessed the safety and efficacy of this novel technology for the treatment of drug-refractory, symptomatic paroxysmal AF. Results at 3 months post-ablation are presented here.
Pulmonary vein isolation (PVI) was performed using a DE focal, irrigated CF-sensing catheter with the recommendation of PFA at posterior/inferior and RF ablation at the anterior/ridge/carina segments. Irrespective of energy, a tag size of 3 mm; an inter-tag distance ≤6 mm; a target index of 550 for anterior, roof, ridge, and carina; and a target index of 400 for posterior and inferior were recommended. Cavotricuspid isthmus ablation was permitted in patients with documented typical atrial flutter. The primary effectiveness endpoint was acute procedural success. The primary safety endpoint was the rate of primary adverse events (PAEs) within 7 days of the procedure. A prespecified patient subset underwent oesophageal endoscopy (EE; 72 h post-procedure), neurological assessment (NA; pre-procedure and discharge), and cardiac computed tomography (CT)/magnetic resonance angiogram (MRA) imaging (pre-procedure and 3 months post-procedure) for additional safety evaluation, and a mandatory remapping procedure (Day 75 ± 15) for PVI durability assessment. Of 149 patients enrolled between February and June 2023, 140 had the study catheter inserted (safety analysis set) and 137 had ablation energy delivered (per-protocol analysis set). The median (Q1/Q3) total procedure and fluoroscopy times were 108.0 (91.0/126.0) and 4.2 (2.3/7.7) min (n = 137). The acute procedural success rate was 100%. First-pass isolation was achieved in 89.1% of patients and 96.8% of veins. Cavotricuspid isthmus ablations were successfully performed in 12 patients pulsed field (PF) only: 6, RF only: 5, and RF/PF: 1. The PAE rate was 4.4% 6/137 patients; 2 pulmonary vein (PV) stenoses, 2 cardiac tamponades/perforations, 1 stroke, and 1 pericarditis. No coronary artery spasm was reported. No oesophageal lesion was seen in the EE subset (0/31, 0%). In the NA subset (n = 30), microemboli lesions were identified in 2 patients (2/30, 6.7%), both of which were resolved at follow-up; only 1 was symptomatic (silent cerebral lesion, 3.3%). In the CT/MRA subset (n = 30), severe PV narrowing (of >70%) was detected in 2 patients (2/30, 6.7%; vein level 2/128, 1.6%), of whom 1 underwent dilatation and stenting and 1 was asymptomatic; both were associated with high index values and a small inter-tag distance. In the PV durability subset (n = 30), 100/115 treated PVs (87%) were durably isolated and 18/30 patients (60.0%) had all PVs durably isolated.
A DE focal CF catheter with 3D mapping integration showed a 100% acute success rate with an acceptable safety profile in the treatment of paroxysmal AF. Prespecified 3-month remapping showed notable PVI durability.
ClinicalTrials.gov Identifier: NCT05752487.
We previously presented the safety and early efficacy of the inspIRE study (Study for Treatment of Paroxysmal Atrial Fibrillation PAF by Pulsed-field Ablation PFA System With Irreversible ...Electroporation IRE). With the study's conclusion, we report the outcomes of the full pivotal study cohort, with an additional analysis of predictors of success.
InspIRE was a prospective, multicenter, single-arm clinical trial of drug-refractory paroxysmal atrial fibrillation. Pulmonary vein isolation was performed with a variable-loop circular catheter integrated with a 3-dimensional mapping system. Follow-up with 24-hour Holter was at 3, 6, and 12 months, as well as remote rhythm monitoring: weekly from 3 to 5 months, monthly from 6 to 12 months, and for symptoms. The primary effectiveness end point (PEE) was acute pulmonary vein isolation plus freedom from any atrial arrhythmia at 12 months. Additional subanalyses report predictors of PEE success.
The patient cohort included 186 patients: aged 59±10 years, female 30%, and CHA
DS
-VASc 1.3±1.2. The previously reported primary adverse event rate was 0%. One serious procedure-related adverse event, urinary retention, was reported. The PEE was achieved in 75.6% (95% CI, 69.5%-81.8%). The clinical success of freedom from symptomatic recurrence was 81.7% (95% CI, 76.1%-87.2%). Simulating a monitoring method used in standard real-world practice (without protocol-driven remote rhythm monitoring), this translates to a freedom from all and symptomatic recurrence of 85.8% (95% CI, 80.8%-90.9%) or 94.0% (95% CI, 90.6%-97.5%), respectively. Multivariate analyses revealed that left ventricular ejection fraction ≥60% (adjusted odds ratio, 0.30) and patients receiving ≥48 PFA applications (adjusted odds ratio, 0.28) were independent predictors of PEE success. Moreover, PEE success was 79.2% in patients who received ≥12 PFA applications per vein compared with 57.1% in patients receiving fewer PFA applications.
The inspIRE study confirms the safety and effectiveness of pulmonary vein isolation using the novel 3-dimensional mapping integrated circular loop catheter. An optimal number of PFA applications (≥48 total or ≥12 per vein) resulted in an improved 1-year success rate of ≈80%.
URL: https://www.clinicaltrials.gov; Unique identifier: NCT04524364.
Recently, the temporal excitable gap during atrial fibrillation (AF) has been identified as a vulnerable parameter for cardioversion of AF. In this study, we evaluated 5 methods to measure the ...refractory period (RP(AF)) and the excitable period (EP(AF)) during persistent AF.
In 11 goats instrumented with 83 epicardial atrial electrodes, persistent AF (43+/-34 days) was induced with a median AF cycle length (CL) of 98+/-14 ms. To measure RP(AF), premature stimuli were applied to the center of the electrode array on the right or left atrium. The RP(AF) measured by mapping of premature stimuli was 70+/-12 ms ("gold standard"). The RP(AF) determined during entrainment of AF was 77+/-17 ms (R(2)=0.88, P<0.01). Statistical analysis of the effects of synchronized stimuli (each coupling interval x100) on the AFCL histogram yielded an RP(AF) of 70+/-13 ms (R(2)=0.94, P<0.01). A further simplification was to apply slow fixed-rate pacing (1 Hz) during AF. For each stimulus (n=250 to 500), the paced AFCL was plotted against its coupling interval, and capture was determined by statistical shortening of the AFCL (RP(AF) 71+/-17 ms, R(2)=0.84, P<0.01). The 5th percentile of the AFCL histogram as an index of RP(AF) was 77+/-12 ms (R(2)=0.90, P<0.01).
During persistent AF with an AFCL of 98+/-14 ms, the RP(AF) determined by mapping of synchronized premature stimuli (gold standard) was 70+/-12 ms, with an excitable period of 28+/-8 ms. Although the indirect methods to measure RP(AF) all correlated well with the gold standard, slow fixed-rate pacing seems to be the most attractive technique because of the ease of acquiring the data and the clear graphic result.
Background. Transseptal puncture (TSP) can be challenging. We compared safety and efficacy of a modified TSP technique (“mosquito” technique, MOSQ-TSP) to conventional TSP (CONV-TSP). Method. ...Patients undergoing AF ablation in whom first attempt of TSP did not result in left atrial (LA) pressure (failure to cross, FTC) were randomized to MOSQ-TSP (i.e., puncture of the fossa via a wafer-thin inner stylet) or CONV-TSP (i.e., additional punctures at different positions). Primary endpoint was LA access. Secondary endpoints were safety, time, fluoroscopic dose (dose-area product, DAP), and number of additional punctures from FTC to final LA access. Result. Of 384 patients, 68 had FTC (MOSQ-TSP, n = 34 versus CONV-TSP, n = 34 ). No complications were reported. In MOSQ-TSP, primary endpoint was 100% (versus 73.5%, p < 0.002 ), median time to LA access was 72 s from 37 to 384 s (versus 326 s from 75 s to 1936 s, p < 0.002 ), mean DAP to LA access was 1778 ± 2315 mGy/cm2 (versus 9347 ± 10690 mGy/cm2, p < 0.002 ), and median number of additional punctures was 2 1 to 3 (versus 0, p < 0.002 ). Conclusion. In AF patients in whom the first attempt of TSP fails, the “mosquito” technique allows effective, safe, and time sparing LA access. This approach might facilitate TSP in elastic, aneurysmatic, or fibrosed septa.
Abstract
Aims
Pulmonary vein isolation (PVI) is a well-established strategy for the treatment of paroxysmal atrial fibrillation (PAF). Despite randomized controlled trials and real-world data showing ...the promise of pulsed-field ablation (PFA) for this treatment, long-term efficacy and safety data demonstrating single-procedure outcomes off antiarrhythmic drugs remain limited. The aim of the FARA-Freedom Study was to evaluate the long-term efficacy and safety of PFA using the pentaspline catheter for PAF.
Methods and results
FARA-Freedom, a prospective, non-randomized, multicentre study, enrolled patients with PAF undergoing de novo PVI with PFA, who were followed for 12 months with weekly transtelephonic monitoring and a 72-h Holter ECG at 6 and 12 months. The primary safety endpoint was a composite of device- or procedure-related serious adverse events out to 7 days post-ablation and PV stenosis or atrioesophageal (AE) fistula out to 12 months. Treatment success is a composite of acute PVI and chronic success, which includes freedom from any documented atrial tachyarrhythmia longer than 30 s, use of antiarrhythmic drugs or cardioversion after a 3-month blanking period, or use of amiodarone or repeat ablation at any time. The study enrolled 179 PAF patients (62 ± 10 years, 39% female) at 13 centres. At the index procedure, all PVs were successfully isolated with the pentaspline PFA catheter. Procedure and left atrial dwell times, with a 20-min waiting period, were 71.9 ± 17.6 and 41.0 ± 13.3 min, respectively. Fluoroscopy time was 11.5 ± 7.4 min. Notably, monitoring compliance was high, with 88.4 and 90.3% with weekly events and 72-h Holter monitors, respectively. Freedom from the composite primary effectiveness endpoint was 66.6%, and 41 patients had atrial tachyarrhythmia recurrence, mostly recurrent atrial fibrillation (31 patients). The composite safety endpoint occurred in two patients (1.1%), one tamponade and one transient ischaemic attack. There was no coronary spasm, PV stenosis, or AE fistula. There were four cases of transient phrenic nerve palsy, but all resolved during the index procedure.
Conclusion
In this prospective, non-randomized, multicentre study, PVI using a pentaspline PFA catheter was effective in treating PAF patients despite rigourous endpoint definitions and high monitoring compliance and demonstrated favourable safety.
Registration
Clinical Trials.gov Identifier: NCT05072964 (sponsor: Boston Scientific Corporation).
Graphical Abstract
Graphical Abstract
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