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1.
Heart Rhythm O2 ; 5(5): 257-265, 2024 May.
Article in English | MEDLINE | ID: mdl-38840763

ABSTRACT

Background: Pulsed-field ablation (PFA) is a novel nonthermal ablation technology. Its potential value for repeat procedures after unsuccessful thermal ablation for atrial fibrillation has not been assessed. Objective: The purpose of this study was to summarize our initial experience with patients undergoing repeat procedures using PFA. Methods: Consecutive patients with arrhythmia recurrences after a prior thermal ablation undergoing a repeat procedure using a multipolar PFA catheter from May 2021 and December 2022 were included. After 3-dimensional electroanatomic mapping, reconnected pulmonary veins (PVs) were reisolated and veins with only ostial isolation wither ablated to widen antral PV isolation. Posterior wall ablation was performed if all PVs were durably isolated or in case of low-voltage areas on the posterior wall at the discretion of the operator. Patients underwent follow-up with 7-day Holter electrocardiography after 3, 6, and 12 months. Results: A total of 186 patients undergoing a repeat procedure using PFA were included. The median number of previous ablations was 1 (range 1-6). The prior ablation modality was radiofrequency in 129 patients (69.4%), cryoballoon in 51 (27.4%), and epicardial ablation in 6 (3.2%). At the beginning of the procedure, 258 of 744 PVs (35%) showed reconnections. Additional antral ablations were applied in 236 of 486 still isolated veins (49%). Posterior wall ablation was added in 125 patients (67%). Major complications occurred in 1 patient (transient ischemic attack 0.5%). Freedom from arrhythmia recurrence in Kaplan-Meier-analysis was 78% after 6 months and 54% after 12 months. Conclusion: PFA is a versatile and safe option for repeat procedures after failed prior thermal ablation.

2.
Europace ; 2024 Jun 25.
Article in English | MEDLINE | ID: mdl-38917059

ABSTRACT

BACKGROUND AND AIMS: Atrial fibrillation (AF) ablation and left atrial appendage occlusion (LAAO) are increasingly performed as individual procedures. Pulsed field ablation (PFA) has significantly reduced procedure duration and may be advantageous for the combined approach. METHODS: We have launched a program for simultaneous AF ablation using PFA and LAAO for patients qualifying for both treatments and excluding those with complex anatomy. We compare procedure duration and fluoroscopy time against individual procedures (either AF ablation or LAAO alone), all performed by the same operators and using consistent technologies. RESULTS: We performed the combined procedure in 10 patients (50% male; median age 70 years) and excluded two patients (17%) because of complex LAA anatomy. No death, stroke or major bleeding, including pericardial effusion, occurred. For single procedure comparison, 207 AF ablation procedures and 61 LAAO procedures were available. Total median procedure duration was 79 minutes (range 60; 125) for the combined procedure, 71 minutes (25; 241) for individual AF ablation (51 minutes without and 78 minutes with 3D electroanatomic mapping) and 47 minutes (15; 162) for individual LAAO. Respective fluoroscopy times were 21 (15; 26), 15 (5; 44) and 10 (3; 50) minutes. For the combined procedure, femoral vein access to last PFA application lasted 49 minutes (34; 93) and LAAO added 20 minutes (15; 37). CONCLUSION: Simultaneous PFA-based AF ablation and LAAO in carefully selected patients is feasible, safe, and can be executed within a short overall procedure duration.

3.
Article in English | MEDLINE | ID: mdl-38869506

ABSTRACT

BACKGROUND: Atrial fibrillation (AF) and heart failure (HF) coexist, increasing morbidity and mortality. Studies have demonstrated improved outcomes following AF ablation in HF patients with reduced ejection fraction (EF). OBJECTIVE: To assess the outcomes of pulsed-field ablation (PFA) in HF. METHODS: MANIFEST-PF is a multicenter patient-level registry of consecutive patients undergoing PFA for paroxysmal (PAF) or persistent AF (PerAF). In this sub-study, patients were stratified as: no history of HF (no-HF), HF with preserved EF (HFPEF; LVEF≥50%) or HF with reduced/mildly-reduced EF (HFMR/REF; LVEF<50%). The primary effectiveness and safety endpoints were freedom from documented atrial arrhythmias lasting ≥30s and major adverse events (MAEs), respectively. RESULTS: Of the 1,381 patients, 85% (n=1,174) were no-HF, 6.2% (n=87) were HFPEF, and 8.6% (n=120) were HFMR/REF. No-HF patients had less PerAF than patients with HF (p<0.001), with no difference between HF subtypes (p=1.00). The 1-year freedom from atrial arrhythmia was significantly higher in no-HF than with HFPEF or HFMR/REF (79.9%, 71.3%, 67.5%, p<0.001), but similar between HFMR/REF and HFPEF (p=0.26). However, there was no significant difference in freedom from atrial arrhythmia among patients with no-HF vs HFPEF vs HFMR/REF for those with PAF (82.8%/82.4%/71.7%, p=0.09) and PerAF (73.3%, 64.2%, and 64.9%, p=0.14.MAE rates were similar between the no-HF, HFPEF and HFMR/REF groups (1.9%, 0%, and 2.5%, respectively). CONCLUSION: PFA appears to be potentially safe and effective in AF patients with HF. Freedom from atrial arrhythmia post-PFA was higher in patients without a history of HF, with no significant difference between HF subtypes.

4.
Article in English | MEDLINE | ID: mdl-38864809

ABSTRACT

BACKGROUND: Atrial fibrillation (AF) and heart failure (HF) coexist, increasing morbidity and mortality. Studies have demonstrated improved outcomes following AF ablation in HF patients with reduced ejection fraction (EF). OBJECTIVE: This study sought to assess the outcomes of pulsed field ablation (PFA) in HF. METHODS: MANIFEST-PF (Multi-National Survey on the Methods, Efficacy, and Safety on the Post-Approval Clinical Use of Pulsed Field Ablation) is a multicenter, patient-level registry of consecutive patients undergoing PFA for paroxysmal AF or persistent AF (PerAF). In this substudy, patients were stratified as no history of HF (no-HF), HF with preserved EF (HFpEF) (left ventricular EF of ≥50%) or HF with reduced/mildly reduced EF (HFmr/rEF) (left ventricular EF of <50%). The primary effectiveness and safety endpoints were freedom from documented atrial arrhythmias lasting ≥30 seconds and major adverse events, respectively. RESULTS: Of the 1,381 patients, 85% (n = 1,174) were no-HF, 6.2% (n = 87) were HFpEF, and 8.6% (n = 120) were HFmr/rEF. No-HF patients had less PerAF than patients with HF (P < 0.001), with no difference between HF subtypes (P = >0.99). The 1-year freedom from atrial arrhythmia was significantly higher in no-HF patients than in those with HFpEF or HFmr/rEF (79.9%, 71.3%, and 67.5%, respectively; P < 0.001) but similar between patients with HFmr/rEF and HFpEF (P = 0.26). However, there was no significant difference in freedom from atrial arrhythmia among patients with no-HF vs HFpEF vs HFmr/rEF for those with paroxysmal AF (82.8%, 82.4%, and 71.7%, respectively; P = 0.09) and PerAF (73.3%, 64.2%, and 64.9%, respectively; P = 0.14). Major adverse event rates were similar between the no-HF, HFpEF, and HFmr/rEF groups (1.9%, 0%, and 2.5%, respectively). CONCLUSIONS: PFA appears to be potentially safe and effective in AF patients with HF. Freedom from atrial arrhythmia post-PFA was higher in patients without a history of HF, with no significant difference between HF subtypes.

5.
Article in English | MEDLINE | ID: mdl-38752963

ABSTRACT

BACKGROUND: Pulmonary vein isolation is an effective treatment for atrial fibrillation (AF). Cryoballoon ablation using the Arctic Front cryoballoon (Medtronic) was found to be superior to antiarrhythmic drug treatment. Recently, a novel cryoballoon system was introduced (PolarX, Boston Scientific). OBJECTIVES: The purpose of this study was to compare the efficacy and safety of the 2 cryoballoons in a randomized controlled trial. METHODS: Patients with symptomatic paroxysmal AF were enrolled in 2 centers and randomized 1:1 to pulmonary vein isolation using the PolarX or the Arctic Front cryoballoon. All patients received an implantable cardiac monitor. The primary endpoint was first recurrence of atrial tachyarrhythmia (AF, atrial flutter, or atrial tachycardia [AT]) between days 91 and 365. Procedural safety was assessed by a composite of tamponade, phrenic nerve palsy lasting >24 hours, vascular complications, stroke/transient ischemic attack, atrioesophageal fistula or death up to 30 days. RESULTS: A total of 201 patients were enrolled. At 1 year, recurrence of atrial tachyarrhythmia had occurred in 41 of 99 patients (41.6%) assigned to the PolarX group and in 48 of 102 patients (47.1%) assigned to the Arctic Front group (HR: 0.85 [95% CI: 0.56-1.30]; P = 0.03 for noninferiority; P = 0.46 for superiority). The safety endpoint occurred in 5 patients (5%) in the PolarX group (n = 5 phrenic nerve palsies lasting >24 hours), whereas no safety endpoints occurred in the Arctic Front group (P = 0.03). CONCLUSIONS: In this randomized controlled trial using implantable cardiac monitors for continuous rhythm monitoring, the novel PolarX cryoballoon was noninferior compared with the Arctic Front cryoballoon regarding efficacy. However, the PolarX balloon resulted in significantly more phrenic nerve palsies. (Comparison of PolarX and the Arctic Front Cryoballoons for PVI in Patients With Symptomatic Paroxysmal AF [COMPARE-CRYO]; NCT04704986).

7.
JACC Clin Electrophysiol ; 10(6): 1090-1100, 2024 Jun.
Article in English | MEDLINE | ID: mdl-38639700

ABSTRACT

BACKGROUND: Recurrence of paroxysmal atrial fibrillation (AF) following pulmonary vein isolation (PVI) is presumably caused by pulmonary vein (PV) reconnections. However, there is little data available on the durability of PVI and incidence of arrhythmia recurrence in patients with persistent AF. OBJECTIVES: The purpose of this study was to evaluate the lesion durability by means of an a priori planned remapping procedure in patients with persistent AF undergoing CLOSE-guided PVI. METHODS: In a prospective study, we included patients with symptomatic, persistent AF undergoing CLOSE-guided radiofrequency ablation. Irrespective of AF recurrence, a redo procedure was mandated 6 months following the index procedure to evaluate PV reconnections. The outcome of AF ablation was based on clinical recurrence and 7-day Holter electrocardiogram 3 and 6 months after the index procedure and 3, 6, and 12 months after the redo procedure. RESULTS: Of 30 patients included, 26 (81% men; median age 68 years) underwent the planned remapping study a median of 6 months after the index procedure, whereas 4 patients without recurrence refused a repeat procedure. In total, 78 of 102 (76%) PVs showed durable isolation and 15 patients (58%) presented complete isolation of all PVs. Beyond the blanking period, 6 of 26 patients (23%) had arrhythmia recurrence before the redo procedure. Recurrence had occurred in 33% of patients with complete isolation of all veins and in 9% of patients with PV reconnections (P = 0.197). After re-PVI in patients with PV reconnections and additional ablation in patients with recurrence but durable PVI, 17 of 26 patients (65%) were free of arrhythmia after 12 months. CONCLUSIONS: In patients with persistent AF, CLOSE-guided PVI resulted in durable rate of PVI on a per-vein and per-patient level of 76% and 58%, respectively. Arrhythmia recurrence was numerically higher in patients with durable PVI compared with patients without.


Subject(s)
Atrial Fibrillation , Catheter Ablation , Pulmonary Veins , Recurrence , Humans , Atrial Fibrillation/surgery , Atrial Fibrillation/physiopathology , Pulmonary Veins/surgery , Male , Female , Prospective Studies , Aged , Catheter Ablation/methods , Catheter Ablation/adverse effects , Middle Aged , Treatment Outcome , Electrocardiography, Ambulatory , Reoperation/statistics & numerical data
8.
Heart Rhythm ; 2024 Apr 11.
Article in English | MEDLINE | ID: mdl-38614191

ABSTRACT

BACKGROUND: Pulsed-field ablation (PFA) has shown promising data in terms of safety and procedural efficiency for pulmonary vein isolation (PVI), with similar long-term outcomes compared to radiofrequency ablation (RFA) and cryoballoon ablation (CBA) in patients with paroxysmal atrial fibrillation (AF). OBJECTIVE: The purpose of this study was to compare the procedural and long-term outcomes in patients with persistent AF undergoing PVI using PFA, CBA, or RFA. METHODS: Consecutive patients with persistent AF undergoing first PVI with PFA, CBA, or RFA were included. Patients underwent 7-day Holter electrocardiography at 3, 6, and 12 months postablation. The primary outcome was recurrence of any atrial arrhythmia after a 90-day blanking period. Safety outcomes included the composite of in-hospital major adverse events. RESULTS: A total of 533 patients with persistent AF underwent PVI using PFA (n = 214, 39%), CBA (n = 190, 36%), or RFA (n = 129, 24%). Procedures with PFA guided by fluoroscopy were shorter than those with CBA (median 60 minutes; interquartile range [IQR] 53-80 minutes vs 84 minutes; IQR 68-101 minutes; P ≤ .001), and procedures with PFA in combination with 3-dimensional electroanatomic mapping were shorter than those with RFA (median 101 minutes; IQR 85-126 minutes vs 171 minutes; IQR 141-204 minutes; P < .001). Acute safety events occurred in 2.3%, 2.6%, and 0.8% in the PFA, CBA, and RFA groups, respectively (P = .545). The 1-year confounder-adjusted estimate for freedom from atrial arrhythmias was 62.1% for CBA, 55.3% for PFA, and 48.3% for RFA (CBA vs PFA: P = .79; CBA vs RFA: P = .009; PFA vs RFA: P = .010). CONCLUSION: In patients with persistent AF undergoing first PVI, 1-year confounder-adjusted outcomes are better with PFA and CBA than with RFA.

9.
JACC Clin Electrophysiol ; 10(5): 900-912, 2024 May.
Article in English | MEDLINE | ID: mdl-38430087

ABSTRACT

BACKGROUND: Pulmonary vein isolation (PVI) alone is insufficient to treat many patients with persistent atrial fibrillation (PersAF). Adjunctive left atrial posterior wall (LAPW) ablation with thermal technologies has revealed lack of efficacy, perhaps limited by the difficulty in achieving lesion durability amid concerns of esophageal injury. OBJECTIVES: This study aims to compare the safety and effectiveness of PVI + LAPW ablation vs PVI in patients with PersAF using pulsed-field ablation (PFA). METHODS: In a retrospective analysis of the MANIFEST-PF (Multi-National Survey on the Methods, Efficacy, and Safety on the Post-approval Clinical Use of Pulsed Field Ablation) registry, we studied consecutive PersAF patients undergoing post-approval treatment with a pentaspline PFA catheter. The primary effectiveness outcome was freedom from any atrial arrhythmia of ≥30 seconds. Safety outcomes included the composite of acute and chronic major adverse events. RESULTS: Of the 547 patients with PersAF who underwent PFA, 131 (24%) received adjunctive LAPW ablation. Compared to PVI-alone, patients receiving adjunctive LAPW ablation were younger (65 vs 67 years of age, P = 0.08), had a lower CHA2DS2-VASc score (2.3 ± 1.6 vs 2.6 ± 1.6, P = 0.08), and were more likely to receive electroanatomical mapping (48.1% vs 39.0%, P = 0.07) and intracardiac echocardiography imaging (46.1% vs 17.1%, P < 0.001). The 1-year Kaplan-Meier estimate for freedom from atrial arrhythmias was not statistically different between groups in the full (PVI + LAPW: 66.4%; 95% CI: 57.6%-74.4% vs PVI: 73.1%; 95% CI: 68.5%-77.2%; P = 0.68) and propensity-matched cohorts (PVI + LAPW: 71.7% vs PVI: 68.5%; P = 0.34). There was also no significant difference in major adverse events between the groups (2.2% vs 1.4%, respectively, P = 0.51). CONCLUSIONS: In patients with PersAF undergoing PFA, as compared to PVI-alone, adjunctive LAPW ablation did not improve freedom from atrial arrhythmia at 12 months.


Subject(s)
Atrial Fibrillation , Catheter Ablation , Heart Atria , Pulmonary Veins , Humans , Atrial Fibrillation/surgery , Male , Female , Aged , Catheter Ablation/methods , Catheter Ablation/adverse effects , Middle Aged , Retrospective Studies , Heart Atria/surgery , Pulmonary Veins/surgery , Treatment Outcome , Registries
10.
JACC Clin Electrophysiol ; 10(4): 698-708, 2024 Apr.
Article in English | MEDLINE | ID: mdl-38340118

ABSTRACT

BACKGROUND: Pulsed-field ablation (PFA) is a novel nonthermal ablation technology with high procedural safety and efficiency for pulmonary vein isolation (PVI). Premarket data showed high PVI durability during mandatory remapping studies. Data on lesion durability in real-world patients with clinically indicated redo procedures are scarce. OBJECTIVES: This study sought to report PVI durability rates in patients undergoing a clinically indicated redo procedure after an index PVI using PFA. METHODS: Patients from 7 European centers undergoing an index PVI using PFA were included the EU-PORIA (European Real-world Outcomes With Pulsed Field Ablation in Patients With Symptomatic Atrial Fibrillation) registry. In patients with subsequent left atrial redo procedures due to arrhythmia recurrence, 3-dimensional electroanatomical maps were acquired. PVI durability was assessed on a per-vein and per-patient level, and sites of reconnections and predictors of lesion durability were identified. RESULTS: Of 1,184 patients (62% paroxysmal atrial fibrillation) undergoing an index PVI using PFA, 272 (23%) had an arrhythmia recurrence. Of these, 144 (53%) underwent a left atrial redo procedure a median of 7 (Q1-Q3: 5-10) months after the first ablation. Three-dimensional electroanatomical maps identified 404 of 567 pulmonary veins (71%) with durable isolation. In 54 patients (38%), all pulmonary veins were durably isolated. Prior operator experience with cryoballoon ablation was associated with a higher PVI durability compared to operators with only point-by-point radiofrequency experience (76% vs 60%; P < 0.001). Neither the operators' cumulative experience in atrial fibrillation ablation (≤5 vs >5 years) nor the size of the PFA device used (31 mm vs 35 mm) had an impact on subsequent lesion durability (both P > 0.50). CONCLUSIONS: In 144 patients with arrhythmia recurrence after PFA PVI, durable isolation was observed in 71% of the pulmonary veins during the redo procedure, and 38% of all patients showed durable isolation of all veins.


Subject(s)
Atrial Fibrillation , Catheter Ablation , Pulmonary Veins , Registries , Humans , Pulmonary Veins/surgery , Atrial Fibrillation/surgery , Male , Female , Middle Aged , Catheter Ablation/methods , Aged , Europe , Treatment Outcome , Recurrence , Reoperation/statistics & numerical data
11.
J Interv Card Electrophysiol ; 67(3): 503-511, 2024 Apr.
Article in English | MEDLINE | ID: mdl-37523023

ABSTRACT

BACKGROUND: A novel multipolar pulsed-field ablation (PFA) catheter has recently been introduced for pulmonary vein isolation (PVI). Pre-market data showed high rates for PVI-durability during mandatory remapping studies. OBJECTIVE: To present post-market data in patients with recurrent arrhythmias. METHODS: Consecutive patients undergoing a redo procedure after an index PFA PVI using a bipolar-biphasic PFA system were included. 3-D electro-anatomical maps (3D-EAM) on redo procedure were compared to the 3D-EAM acquired after ablation during the index procedure. PVI durability was assessed on a per-vein and per-patient level and the sites of reconnections were identified. Furthermore, lesion extent around veins with durable isolation was compared to study lesion regression. RESULTS: Of 341 patients treated with a PFA PVI, 29 (8.5%) underwent a left atrial redo ablation due to arrhythmia recurrence. At the end of the index procedure, 110/112 veins (98%, four common ostia) were isolated. On redo procedures performed a median of 6 months after the first ablation, 3D-EAM identified 69/110 (63%) PVs with durable isolation. In 6 (21%) patients, all PVs were durably isolated. Reconnections were more often found on the right-sided veins and on the anterior aspects of the upper veins. Only minor lesion regression was observed between the index and redo procedure (a median of 3 mm (0 - 9.5) on the posterior wall). CONCLUSION: In patients with arrhythmia recurrence after PFA PVI using a first-generation PFA device, durable isolation was observed in 63% of the veins and 21% of the patients showed durable isolation of all previously isolated veins.


Subject(s)
Atrial Fibrillation , Catheter Ablation , Cryosurgery , Pulmonary Veins , Humans , Pulmonary Veins/surgery , Heart Atria/surgery , Cryosurgery/methods , Reoperation/methods , Catheter Ablation/methods , Treatment Outcome , Recurrence
12.
J Interv Card Electrophysiol ; 67(2): 389-397, 2024 Mar.
Article in English | MEDLINE | ID: mdl-37776355

ABSTRACT

BACKGROUND: Pulsed-field ablation (PFA) has shown favourable data in terms of safety and procedural efficiency for pulmonary vein isolation (PVI). We sought to compare procedural and 1-year follow-up data of patients with paroxysmal atrial fibrillation (AF) undergoing PVI using PFA, cryoballoon ablation (CBA) and radiofrequency ablation (RFA). METHODS: Consecutive patients with paroxysmal AF undergoing a first PVI with PFA at our institution were included. For comparison, patients with paroxysmal AF undergoing a first PVI with CBA and RFA were selected using a 1:2:2 propensity score matching. The PFA group followed the standard 32-applications lesion-set protocol, the CBA group a time-to-effect plus 2-min strategy, and the RFA group the CLOSE protocol. Patients were followed with 7d-Holter ECGs 3, 6, and 12 months after ablation. The primary endpoint was recurrence of atrial tachyarrhythmia (ATa) following a blanking period of 3 months. RESULTS: A total of 200 patients were included (PFA n = 40; CBA n = 80; RFA n = 80). Median procedure times were shortest with CBA (75 min) followed by PFA (94 min) and RFA (182 min; p < 0.001). Fluoroscopy dose was lowest with RFA (1.6Gycm2) followed by PFA (5.0Gycm2) and CBA (5.7Gycm2; p < 0.001). After a 1-year follow-up, freedom from ATa recurrence was 85.0% with PFA, 66.2% with CBA and 73.8% with RFA (p = 0.12 PFA vs. CBA; p = 0.27 PFA vs. RFA). CONCLUSION: In a propensity score matched analysis of patients with paroxysmal AF, freedom from any ATa 1 year after PVI using PFA was favourable and at least as good as for PVI with CBA or RFA.


Subject(s)
Atrial Fibrillation , Catheter Ablation , Cryosurgery , Pulmonary Veins , Radiofrequency Ablation , Humans , Atrial Fibrillation/surgery , Pulmonary Veins/surgery , Propensity Score , Treatment Outcome , Cryosurgery/methods , Catheter Ablation/methods , Recurrence
13.
JAMA Cardiol ; 8(12): 1142-1151, 2023 12 01.
Article in English | MEDLINE | ID: mdl-37910101

ABSTRACT

Importance: Previous studies evaluating the association of patient sex with clinical outcomes using conventional thermal ablative modalities for atrial fibrillation (AF) such as radiofrequency or cryoablation are controversial due to mixed results. Pulsed field ablation (PFA) is a novel AF ablation energy modality that has demonstrated preferential myocardial tissue ablation with a unique safety profile. Objective: To compare sex differences in patients undergoing PFA for AF in the Multinational Survey on the Methods, Efficacy, and Safety on the Postapproval Clinical Use of Pulsed Field Ablation (MANIFEST-PF) registry. Design, Setting, and Participants: This was a retrospective cohort study of MANIFEST-PF registry data, which included consecutive patients undergoing postregulatory approval treatment with PFA to treat AF between March 2021 and May 2022 with a median follow-up of 1 year. MANIFEST-PF is a multinational, retrospectively analyzed, prospectively enrolled patient-level registry including 24 European centers. The study included all consecutive registry patients (age ≥18 years) who underwent first-ever PFA for paroxysmal or persistent AF. Exposure: PFA was performed on patients with AF. All patients underwent pulmonary vein isolation and additional ablation, which was performed at the discretion of the operator. Main Outcomes and Measures: The primary effectiveness outcome was freedom from clinically documented atrial arrhythmia for 30 seconds or longer after a 3-month blanking period. The primary safety outcome was the composite of acute (<7 days postprocedure) and chronic (>7 days) major adverse events (MAEs). Results: Of 1568 patients (mean [SD] age, 64.5 [11.5] years; 1015 male [64.7%]) with AF who underwent PFA, female patients, as compared with male patients, were older (mean [SD] age, 68 [10] years vs 62 [12] years; P < .001), had more paroxysmal AF (70.2% [388 of 553] vs 62.4% [633 of 1015]; P = .002) but had fewer comorbidities such as coronary disease (9% [38 of 553] vs 15.9% [129 of 1015]; P < .001), heart failure (10.5% [58 of 553] vs 16.6% [168 of 1015]; P = .001), and sleep apnea (4.7% [18 of 553] vs 11.7% [84 of 1015]; P < .001). Pulmonary vein isolation was performed in 99.8% of female (552 of 553) and 98.9% of male (1004 of 1015; P = .90) patients. Additional ablation was performed in 22.4% of female (124 of 553) and 23.1% of male (235 of 1015; P = .79) patients. The 1-year Kaplan-Meier estimate for freedom from atrial arrhythmia was similar in male and female patients (79.0%; 95% CI, 76.3%-81.5% vs 76.3%; 95% CI, 72.5%-79.8%; P = .28). There was also no significant difference in acute major AEs between groups (male, 1.5% [16 of 1015] vs female, 2.5% [14 of 553]; P = .19). Conclusion and Relevance: Results of this cohort study suggest that after PFA for AF, there were no significant sex differences in clinical effectiveness or safety events.


Subject(s)
Atrial Fibrillation , Humans , Male , Female , Middle Aged , Aged , Adolescent , Atrial Fibrillation/drug therapy , Retrospective Studies , Cohort Studies , Sex Factors , Treatment Outcome
14.
Contemp Clin Trials ; 134: 107341, 2023 Nov.
Article in English | MEDLINE | ID: mdl-37722483

ABSTRACT

INTRODUCTION: Single-shot devices are increasingly used for pulmonary vein isolation (PVI) in atrial fibrillation (AF). The Arctic Front cryoballoon (Medtronic) is the most frequently used single-shot technology. A recently developed novel cryoballoon has been introduced (PolarX, Boston Scientific) with the aim to address limitations of the Arctic Front system. METHODS: COMPARE CRYO is a multicentre, randomized, controlled trial with blinded endpoint adjudication by an independent clinical events committee. A total of 200 patients with paroxysmal AF undergoing their first PVI are randomized 1:1 between PolarX cryoballoon ablation and Arctic Front cryoballoon ablation. Continuous monitoring during follow-up is performed using an implantable cardiac monitor (ICM) in all patients. The primary endpoint is time to first recurrence of any atrial tachyarrhythmia (AF, atrial flutter, and/or atrial tachycardia) ≥ 120 s between days 91 and 365 post ablation as detected on the (ICM). Procedural safety is assessed by a composite of cardiac tamponade, persistent phrenic nerve palsy >24 h, vascular complications requiring intervention, stroke/transient ischemic attack, atrioesophageal fistula or death occurring during or up to 30 days after the procedure. Key secondary endpoints include (1) procedure and fluoroscopy times, (2) AF burden, (3) proportion of patients with recurrence in the blanking period, (4) proportion of patients undergoing repeat ablation, and (5) quality of life changes at 12 months compared to baseline. CONCLUSION: COMPARE CRYO will compare the efficacy and safety of the novel PolarX cryoballoon and the standard-of-practice Arctic Front cryoballoon for first PVI performed in patients with symptomatic paroxysmal AF. TRIAL REGISTRATION: (ClinicalTrials.gov ID: NCT04704986).


Subject(s)
Atrial Fibrillation , Catheter Ablation , Cryosurgery , Pulmonary Veins , Humans , Atrial Fibrillation/surgery , Treatment Outcome , Pulmonary Veins/surgery , Quality of Life , Cryosurgery/methods , Catheter Ablation/methods , Recurrence , Randomized Controlled Trials as Topic , Multicenter Studies as Topic
16.
Europace ; 25(7)2023 07 04.
Article in English | MEDLINE | ID: mdl-37379528

ABSTRACT

AIMS: Pulsed field ablation (PFA) is a new, non-thermal ablation modality for pulmonary vein (PV) isolation in patients with atrial fibrillation (AF). The multi-centre EUropean Real World Outcomes with Pulsed Field AblatiOn in Patients with Symptomatic AtRIAl Fibrillation (EU-PORIA) registry sought to determine the safety, efficacy, and learning curve characteristics for the pentaspline, multi-electrode PFA catheter. METHODS AND RESULTS: All-comer AF patients from seven high-volume centres were consecutively enrolled. Procedural and follow-up data were collected. Learning curve effects were analysed by operator ablation experience and primary ablation modality. In total, 1233 patients (61% male, mean age 66 ± 11years, 60% paroxysmal AF) were treated by 42 operators. In 169 patients (14%), additional lesions outside the PVs were performed, most commonly at the posterior wall (n = 127). Median procedure and fluoroscopy times were 58 (interquartile range: 40-87) and 14 (9-21) min, respectively, with no differences due to operator experience. Major complications occurred in 21/1233 procedures (1.7%) including pericardial tamponade (14; 1.1%) and transient ischaemic attack or stroke (n = 7; 0.6%), of which one was fatal. Prior cryoballoon users had less complication. At a median follow-up of 365 (323-386) days, the Kaplan-Meier estimate of arrhythmia-free survival was 74% (80% for paroxysmal and 66% for persistent AF). Freedom from arrhythmia was not influenced by operator experience. In 149 (12%) patients, a repeat procedure was performed due to AF recurrence and 418/584 (72%) PVs were durably isolated. CONCLUSION: The EU-PORIA registry demonstrates a high single-procedure success rate with an excellent safety profile and short procedure times in a real-world, all-comer AF patient population.


Subject(s)
Atrial Fibrillation , Catheter Ablation , Poria , Pulmonary Veins , Humans , Male , Middle Aged , Aged , Female , Atrial Fibrillation/diagnosis , Atrial Fibrillation/surgery , Atrial Fibrillation/epidemiology , Treatment Outcome , Catheter Ablation/adverse effects , Catheter Ablation/methods , Fluoroscopy , Pulmonary Veins/surgery , Recurrence
17.
Circulation ; 148(1): 35-46, 2023 07 04.
Article in English | MEDLINE | ID: mdl-37199171

ABSTRACT

BACKGROUND: Pulsed field ablation is a novel nonthermal cardiac ablation modality using ultra-rapid electrical pulses to cause cell death by a mechanism of irreversible electroporation. Unlike the traditional ablation energy sources, pulsed field ablation has demonstrated significant preferentiality to myocardial tissue ablation, and thus avoids certain thermally mediated complications. However, its safety and effectiveness remain unknown in usual clinical care. METHODS: MANIFEST-PF (Multi-National Survey on the Methods, Efficacy, and Safety on the Post-Approval Clinical Use of Pulsed Field Ablation) is a retrospective, multinational, patient-level registry wherein patients at each center were prospectively included in their respective center registries. The registry included all patients undergoing postapproval treatment with a multielectrode 5-spline pulsed field ablation catheter to treat atrial fibrillation (AF) between March 1, 2021, and May 30, 2022. The primary effectiveness outcome was freedom from clinical documented atrial arrhythmia (AF/atrial flutter/atrial tachycardia) of ≥30 seconds on the basis of electrocardiographic data after a 3-month blanking period (on or off antiarrhythmic drugs). Safety outcomes included the composite of acute (<7 days postprocedure) and latent (>7 days) major adverse events. RESULTS: At 24 European centers (77 operators) pulsed field ablation was performed in 1568 patients with AF: age 64.5±11.5 years, female 35%, paroxysmal/persistent AF 65%/32%, CHA2DS2-VASc 2.2±1.6, median left ventricular ejection fraction 60%, and left atrial diameter 42 mm. Pulmonary vein isolation was achieved in 99.2% of patients. After a median (interquartile range) follow-up of 367 (289-421) days, the 1-year Kaplan-Meier estimate for freedom from atrial arrhythmia was 78.1% (95% CI, 76.0%-80.0%); clinical effectiveness was more common in patients with paroxysmal AF versus persistent AF (81.6% versus 71.5%; P=0.001). Acute major adverse events occurred in 1.9% of patients. CONCLUSIONS: In this large observational registry of the postapproval clinical use of pulsed field technology to treat AF, catheter ablation using pulsed field energy was clinically effective in 78% of patients with AF.


Subject(s)
Atrial Fibrillation , Atrial Flutter , Catheter Ablation , Pulmonary Veins , Humans , Female , Middle Aged , Aged , Atrial Fibrillation/diagnosis , Atrial Fibrillation/surgery , Atrial Fibrillation/drug therapy , Retrospective Studies , Stroke Volume , Ventricular Function, Left , Treatment Outcome , Atrial Flutter/etiology , Registries , Catheter Ablation/adverse effects , Catheter Ablation/methods , Recurrence
18.
J Interv Card Electrophysiol ; 66(9): 2047-2054, 2023 Dec.
Article in English | MEDLINE | ID: mdl-37014482

ABSTRACT

BACKGROUND: Superimposition of farfield (FF) and nearfield (NF) bipolar voltage electrograms (BVE) complicates the confirmation of pulmonary vein (PV) isolation after catheter ablation of atrial fibrillation. Our aim was to develop an automatic algorithm based on a single-beat analysis to discriminate PV NF from atrial FF BVE from a circular mapping catheter during the cryoballoon PV isolation. METHODS: During freezing cycles in cryoablation PVI, local NF and distant FF signals were recorded, identified and labelled. BVEs were classified using four different machine learning algorithms based on four frequency domain (high-frequency power (PHF), low-frequency power (PLF), relative high power band, PHF ratio of neighbouring electrodes) and two time domain features (amplitude (Vmax), slew rate). The algorithm-based classification was compared to the true identification gained during the PVI and to a classification by cardiac electrophysiologists. RESULTS: We included 335 BVEs from 57 consecutive patients. Using a single feature, PHF with a cut-off at 150 Hz showed the best overall accuracy for classification (79.4%). By combining PHF with Vmax, overall accuracy was improved to 82.7% with a specificity of 89% and a sensitivity of 77%. The overall accuracy was highest for the right inferior PV (96.6%) and lowest for the left superior PV (76.9%). The algorithm showed comparable accuracy to the classification by the EP specialists. CONCLUSIONS: An automated farfield-nearfield discrimination based on two simple features from a single-beat BVE is feasible with a high specificity and comparable accuracy to the assessment by experienced cardiac electrophysiologists.


Subject(s)
Atrial Fibrillation , Catheter Ablation , Cryosurgery , Pulmonary Veins , Humans , Electrocardiography , Pulmonary Veins/surgery , Atrial Fibrillation/diagnosis , Atrial Fibrillation/surgery , Electrophysiologic Techniques, Cardiac , Algorithms , Treatment Outcome
19.
Pacing Clin Electrophysiol ; 46(5): 365-375, 2023 05.
Article in English | MEDLINE | ID: mdl-36912446

ABSTRACT

BACKGROUND: The implantation procedure of left ventricular (LV) leads and the management of cardiac resynchronization therapy (CRT) patients can be challenging. The IS-4 standard for CRT offers additional pacing vectors compared to bipolar leads (IS-1). IS-4 leads improve procedural outcome and may also result in lower adverse events during follow-up (FU) and improve clinical outcome in CRT patients. Further long-term FU data comparing the two lead designs are necessary. METHODS: In this retrospective, single-center study we included adult patients implanted with a CRT-Defibrillator (CRT-D) or CRT-Pacemaker (CRT-P) with a quadripolar (IS-4 group) or bipolar (IS-1 group) LV lead and with available ≥3 years clinical FU. The combined primary endpoint was a combination of predefined, lead-related adverse events. Secondary endpoints were all single components of the primary endpoint. RESULTS: Overall, 133 patients (IS-4 n = 66; IS-1 n = 67) with a mean FU of 4.03 ± 1.93 years were included. Lead-related adverse events were less frequent in patients with an IS-4 lead than with an IS-1 lead (n = 8, 12.1% vs. n = 23, 34.3%; p = .002). The secondary outcomes showed a lower rate of LV lead deactivation/explantation and LV lead dislodgement/dysfunction (4.5% vs. 22.4%; p = .003; 4.5% vs. 17.9%; p = .015, respectively) in the IS-4 patient group. Less patients suffered from unresolved phrenic nerve stimulation with an IS-4 lead (3.0% vs. 13.4%; p = .029). LV lead-related re-interventions were fewer in case of an IS-4 lead (6.1% vs. 17.9%; p = .036). CONCLUSION: In this retrospective analysis, the IS-4 LV lead is associated with lower lead-related complication rates than the IS-1 lead at long-term FU.


Subject(s)
Bipolar Disorder , Cardiac Resynchronization Therapy , Heart Failure , Ventricular Dysfunction, Left , Adult , Humans , Cardiac Resynchronization Therapy/methods , Cardiac Resynchronization Therapy Devices , Retrospective Studies , Bipolar Disorder/therapy , Treatment Outcome , Ventricular Dysfunction, Left/therapy , Registries , Electrodes, Implanted
20.
Europace ; 25(4): 1500-1502, 2023 04 15.
Article in English | MEDLINE | ID: mdl-36892147

ABSTRACT

AIMS: Pulsed field ablation (PFA) for pulmonary vein isolation (PVI) combines the benefits of high procedural efficacy and safety. Transseptal puncture (TSP) to obtain left atrial (LA) access during PVI remains an important source of complications during LA procedures. For PFA procedures, TSP is generally performed using a standard transseptal sheath that is then exchanged over the wire for a dedicated PFA sheath, which might be a potential source for air embolism. We aimed to prospectively evaluate the feasibility and safety of a simplified workflow using the PFA sheath (Faradrive, Boston Scientific) directly for TSP. METHODS AND RESULTS: We prospectively enrolled 100 patients undergoing PVI using PFA at two centres. TSP was performed using the PFA sheath and a standard 98 cm transseptal needle under fluoroscopic guidance. TSP via the PFA sheath was successfully performed in all patients and no complications occurred. The median time from the first groin puncture to the completed LA access was 12 min (IQR 8-16 min). CONCLUSION: An over-the-needle TSP directly with the PFA sheath proved feasible and safe in our study. This simplified workflow has the potential to reduce the risk of air embolism, to shorten procedure time, and to reduce cost.


Subject(s)
Atrial Fibrillation , Catheter Ablation , Embolism, Air , Humans , Atrial Fibrillation/diagnosis , Atrial Fibrillation/surgery , Embolism, Air/surgery , Catheter Ablation/adverse effects , Catheter Ablation/methods , Heart Atria/surgery , Punctures/methods , Treatment Outcome
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