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2.
Heart Rhythm O2 ; 5(6): 385-395, 2024 Jun.
Article in English | MEDLINE | ID: mdl-38984363

ABSTRACT

Background: Pulsed-field ablation (PFA) is an alternative to thermal ablation (TA) in patients with atrial fibrillation (AF) receiving catheter-based therapy for pulmonary vein isolation (PVI). However, its efficacy and safety have yet to be fully elucidated. Objective: The purpose of this study was to compare the acute and long-term efficacies and safety of PFA and TA. Methods: We performed a systematic review and meta-analysis of randomized and nonrandomized controlled trials comparing PFA and TA in patients with AF undergoing their first PVI ablation. The TA group was divided into cryoballoon (CB) and radiofrequency subgroups. AF patients were divided into paroxysmal atrial fibrillation (PAF) and persistent atrial fibrillation (PersAF) subgroups for further analysis. Results: Eighteen studies involving 4998 patients (35.2% PFA) were included. Overall, PFA was associated with a shorter procedure time (mean difference [MD] -21.68; 95% confidence interval [CI] -32.81 to -10.54) but longer fluoroscopy time (MD 4.53; 95% CI 2.18-6.88) than TA. Regarding safety, lower (peri-)esophageal injury rates (odds ratio [OR] 0.17; 95% CI 0.06-0.46) and higher tamponade rates (OR 2.98; 95% CI 1.27-7.00) were observed after PFA. In efficacy assessment, PFA was associated with a better first-pass isolation rate (OR 6.82; 95% CI 1.37-34.01) and a lower treatment failure rate (OR 0.83; 95% CI 0.70-0.98). Subgroup analysis showed no differences in PersAF and PAF. CB was related to higher (peri)esophageal injury, and lower PVI acute success and procedural time. Conclusion: Compared to TA, PFA showed better results with regard to acute and long-term efficacy but significant differences in safety, with lower (peri)esophageal injury rates but higher tamponade rates in procedural data.

5.
Heart Rhythm ; 2024 Jul 04.
Article in English | MEDLINE | ID: mdl-38971417

ABSTRACT

BACKGROUND: Idiopathic epicardial premature ventricular contractions (PVCs) originating from the left ventricular summit are difficult to eliminate. OBJECTIVE: To describe feasibility and procedural safety of focal monopolar biphasic pulsed field ablation (F-PFA) from within the great cardiac vein (GCV) for the treatment of idiopathic epicardial PVCs. METHODS: In 4 pigs, F-PFA (CENTAURI, Cardiofocus) was applied from within the GCV followed by macroscopic gross analysis. In 4 patients with previously failed radiofrequency ablation, electroanatomic mapping was used to guide F-PFA from within the GCV and the ventricular outflow tracts. Coronary angiography and optical coherence tomography (OCT) were performed in 2 patients. RESULTS: In pigs, F-PFA from within the GCV (5mm away from the coronary arteries) resulted in myocardial lesions with a maximal depth of 4mm which was associated with non-obstructive transient coronary spasms. In patients, sequential delivery of F-PFA in the ventricular outflow tracts and from within the GCV eliminated the PVCs. During F-PFA delivery from within the GCV with prophylactic nitroglycerin application, coronary angiography showed no coronary spasm when F-PFA was delivered >5mm away from the coronary artery and a transient coronary spasm without changes in a subsequent OCT, when F-PFA was delivered directly on the coronary artery. Intracardiac echo and computer tomography integration was used to monitor F-PFA delivery from within the GCV. There were no immediate or short-term complications. CONCLUSION: Sequential mapping-guided F-PFA from endocardial ventricular outflow tracts and from within the GCV is feasible with a favourable procedural safety profile for the treatment of epicardial PVC.

6.
Article in English | MEDLINE | ID: mdl-38878017

ABSTRACT

BACKGROUND: Comparative efficacy and safety data on radiofrequency ablation (RFA) versus pulsed field ablation (PFA) for common idiopathic left ventricular arrhythmia (LV-VAs) locations are lacking. OBJECTIVES: This study sough to compare RFA with PFA of common idiopathic LV-VAs locations. METHODS: Ten swine were randomized to PFA or RFA of LV interventricular septum, papillary muscle, LV summit via distal coronary sinus, and LV epicardium via subxiphoid approach. Ablations were delivered using an investigational dual-energy (RFA/PFA) contact force (CF) and local impedance-sensing catheter. After 1-week survival, animals were euthanized for lesion assessment. RESULTS: A total of 55 PFA (4 applications/site of 2.0 KV, target CF ≥10 g) and 36 RFA (CF ≥10 g, 25-50 W targeting ≥50 Ω local impedance drop, 60-second duration) were performed. LV interventricular septum: average PFA depth 7.8 mm vs RFA 7.9 mm (P = 0.78) and no adverse events. Papillary muscle: average PFA depth 8.1 mm vs RFA 4.5 mm (P < 0.01). Left ventricular summit: average PFA depth 5.6 mm vs RFA 2.7 mm (P < 0.01). Steam-pop and/or ventricular fibrillation in 4 of 12 RFA vs 0 of 12 PFA (P < 0.01), no ST-segment changes observed. Epicardium: average PFA depth 6.4 mm vs RFA 3.3 mm (P < 0.01). Transient ST-segment elevations/depressions occurred in 4 of 5 swine in the PFA arm vs 0 of 5 in the RFA arm (P < 0.01). Angiography acutely and at 7 days showed normal coronaries in all cases. CONCLUSIONS: In this swine study, compared with RFA, PFA of common idiopathic LV-VAs locations produced deeper lesions with fewer steam pops. However, PFA was associated with higher rates of transient ST-segment elevations and depressions with direct epicardium ablation.

7.
Europace ; 2024 Jun 14.
Article in English | MEDLINE | ID: mdl-38875490

ABSTRACT

AIMS: Superior vena cava (SVC) isolation during atrial fibrillation (AF) catheter ablation is limited by the risk of collateral damage to the sinus node and/or the phrenic nerve. Due to its tissue-specificity, we hypothesized the feasibility and safety of pulsed-field ablation (PFA)-based SVC isolation. METHODS AND RESULTS: A hundred and five consecutive patients undergoing PFA-based AF catheter ablation were prospectively included. After pulmonary vein isolation (± posterior wall isolation and electrical cardioversion), SVC isolation was performed using a standardized workflow. Acute SVC isolation was achieved in 105/105 (100%) patients after 6 ± 1 applications. Transient phrenic nerve stunning occurred in 67/105 (64%) patients but without phenic nerve palsy at the end of the procedure and at hospital discharge. Transient high degree sinus node dysfunction occurred in 5/105 (4.7%) patients, with no recurrence at the end of the procedure and until discharge. At the 3-month follow-up visit, no complication occurred. CONCLUSION: SVC isolation using a pentaspline PFA catheter is feasible and safe.

8.
J Clin Med ; 13(11)2024 May 26.
Article in English | MEDLINE | ID: mdl-38892824

ABSTRACT

Background: Pulmonary vein isolation (PVI) is the standard of care for the treatment of symptomatic atrial fibrillation (AF). Novel techniques for PVI are the thermal size-adjustable cryo-balloon (CB) system and non-thermal pulsed field ablation (PFA) system. There are currently no data available for a direct comparison between these two systems. Furthermore, with new techniques, it is important to ensure a high level of efficiency and safety during treatment right from initial use. Therefore, the aim of this study was to directly compare the procedural data and safety of these two new PVI techniques in first-time users. Methods: We conducted a single-center prospective study involving 100 consecutive patients with symptomatic atrial fibrillation who underwent first-time PVI using either size-adjustable CB PVI or PFA PVI from July 2023 to March 2024. Results: Acute PVI was achieved in 100% of patients in both groups. First-pass isolation (FPI) was more frequently achieved in the PFA group compared to the size-adjustable CB group. The mean procedural duration and fluoroscopy dose were significantly shorter in the PFA cohort (p < 0.001). Furthermore, a significant reduction in fluoroscopy time was observed during the learning curve within the PFA group (p = 0.023). There were no major complications in both groups. Conclusions: Both systems demonstrate good effectiveness and safety during PVI performed by first-time users. However, the PFA group exhibited a significantly shorter procedural duration.

9.
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.

10.
Heart Rhythm ; 2024 Jun 24.
Article in English | MEDLINE | ID: mdl-38925335

ABSTRACT

BACKGROUND: Early recurrence of atrial tachyarrhythmias (ERATs) within three months following thermal ablation for atrial fibrillation (AF) is common and often considered transient. Pulsed field ablation (PFA) is a non-thermal energy source in which ERAT is not well described. OBJECTIVE: To analyze ERAT in AF patients undergoing PFA in the PULSED AF trial. METHODS: This analysis included 294 patients (154 paroxysmal, 140 persistent AF) that had ≥10 rhythm assessments during the 90-day blanking period. ERAT was defined as any instance of ≥30s of AF, atrial flutter, or atrial tachycardia on trans-telephonic monitoring (weekly and symptomatic) or ≥10s on ECG (at 3 months), both within 90 days. Late recurrence of atrial tachyarrhythmias (LRATs) was defined as observed atrial tachyarrhythmias between 90 days and 12 months. RESULTS: The overall prevalence of ERAT was 27.1% in paroxysmal and 31.6% in persistent AF patients. In patients with ERAT, 73% had ERAT onset within the first month post-procedure. Presence of ERAT was associated with LRAT in paroxysmal (HR 6.4 (95% c.i. 3.6-11.3)) and persistent (HR 3.8 (95% c.i. 2.2-6.6)) AF patients. Yet, in 29.4% of paroxysmal and 34.3% of persistent AF patients with ERAT, LRAT was not observed. LRAT was positively correlated with the number of ERAT observations. CONCLUSION: ERAT post PFA predicted LRAT in paroxysmal and persistent AF patients. However, the concept of a blanking period post PFA is still valid as approximately 1/3 of patients with ERAT did not continue on to LRAT during follow-up and may not need re-ablation.

12.
Europace ; 26(6)2024 Jun 03.
Article in English | MEDLINE | ID: mdl-38916275

ABSTRACT

AIMS: Technological advancements have contributed to the enhanced precision and lesion flexibility in pulsed-field ablation (PFA) by integrating a three-dimensional mapping system combined with a point-by-point ablation strategy. Data regarding the feasibility of this technology remain limited to some clinical trials. This study aims to elucidate initial real-world data on catheter ablation utilizing a lattice-tip focal PFA/radiofrequency ablation (RFA) catheter in patients with persistent atrial fibrillation (AF). METHODS AND RESULTS: Consecutive patients who underwent catheter ablation for persistent AF via the lattice-tip PFA/RFA catheter were enrolled. We evaluated acute procedural data including periprocedural data as well as the clinical follow-up within a 90-day blanking period. In total, 28 patients with persistent AF underwent AF ablation either under general anaesthesia (n = 6) or deep sedation (n = 22). In all patients, pulmonary vein isolation was successfully achieved. Additional linear ablations were conducted in 21 patients (78%) with a combination of successful anterior line (n = 13, 46%) and roof line (n = 19, 68%). The median procedural and fluoroscopic times were 97 (interquartile range, IQR: 80-114) min and 8.5 (IQR: 7.2-9.5) min, respectively. A total of 27 patients (96%) were interviewed during the follow-up within the blanking period, and early recurrent AF was documented in four patients (15%) including one case of recurrent AF during the hospital stay. Neither major nor minor procedural complication occurred. CONCLUSION: In terms of real-world data, our data confirmed AF ablation feasibility utilizing the lattice-tip focal PFA/RFA catheter in patients with persistent AF.


Subject(s)
Atrial Fibrillation , Catheter Ablation , Equipment Design , Pulmonary Veins , Humans , Atrial Fibrillation/surgery , Atrial Fibrillation/diagnosis , Atrial Fibrillation/physiopathology , Male , Catheter Ablation/methods , Catheter Ablation/instrumentation , Female , Middle Aged , Treatment Outcome , Aged , Pulmonary Veins/surgery , Cardiac Catheters , Recurrence , Time Factors
13.
Front Physiol ; 15: 1395923, 2024.
Article in English | MEDLINE | ID: mdl-38911328

ABSTRACT

Introduction: Pulsed Field Ablation (PFA) is a novel non-thermal method for cardiac ablation, relying on irreversible electroporation induced by high-energy pulsed electric fields (PEFs) to create localized lesions in the heart atria. A significant challenge in optimizing PFA treatments is determining the lethal electric field threshold (EFT), which governs ablation volume and varies with PEF waveform parameters. However, the proprietary nature of device developer's waveform characteristics and the lack of standardized nonclinical testing methods have left optimal EFTs for cardiac ablation uncertain. Methods: To address this gap, we introduced a laboratory protocol employing human induced pluripotent stem cell-derived cardiomyocytes (hiPSC-CMs) in monolayer format to evaluate the impact of a range of clinically relevant biphasic pulse parameters on lethal EFT and adiabatic heating (AH). Cell death areas were assessed using fluorescent dyes and confocal microscopy, while lethal EFTs were quantified through comparison with electric field numerical simulations. Results and conclusion: Our study confirmed a strong correlation between cell death in hiPSC-CMs and the number and duration of pulses in each train, with pulse repetition frequency exerting a comparatively weaker influence. Fitting of these results through machine learning algorithms were used to develop an open-source online calculator. By estimating lethal EFT and associated temperature increases for diverse pulse parameter combinations, this tool, once validated, has the potential to significantly reduce reliance on animal models during early-stage device de-risking and performance assessment. This tool also offers a promising avenue for advancing PFA technology for cardiac ablation medical devices to enhance patient outcomes.

15.
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.

16.
J Am Coll Cardiol ; 84(1): 61-74, 2024 07 02.
Article in English | MEDLINE | ID: mdl-38864538

ABSTRACT

BACKGROUND: The ADVENT randomized trial revealed no significant difference in 1-year freedom from atrial arrhythmias (AA) between thermal (radiofrequency/cryoballoon) and pulsed field ablation (PFA). However, recent studies indicate that the postablation AA burden is a better predictor of clinical outcomes than the dichotomous endpoint of 30-second AA recurrence. OBJECTIVES: The goal of this study was to determine: 1) the impact of postablation AA burden on outcomes; and 2) the effect of ablation modality on AA burden. METHODS: In ADVENT, symptomatic drug-refractory patients with paroxysmal atrial fibrillation underwent PFA or thermal ablation. Postablation transtelephonic electrocardiogram monitor recordings were collected weekly or for symptoms, and 72-hour Holters were at 6 and 12 months. AA burden was calculated from percentage AA on Holters and transtelephonic electrocardiogram monitors. Quality-of-life assessments were at baseline and 12 months. RESULTS: From 593 randomized patients (299 PFA, 294 thermal), using aggregate PFA/thermal data, an AA burden exceeding 0.1% was associated with a significantly reduced quality of life and an increase in clinical interventions: redo ablation, cardioversion, and hospitalization. There were more patients with residual AA burden <0.1% with PFA than thermal ablation (OR: 1.5; 95% CI: 1.0-2.3; P = 0.04). Evaluation of outcomes by baseline demographics revealed that patients with prior failed class I/III antiarrhythmic drugs had less residual AA burden after PFA compared to thermal ablation (OR: 2.5; 95% CI: 1.4-4.3; P = 0.002); patients receiving only class II/IV antiarrhythmic drugs pre-ablation had no difference in AA burden between ablation groups. CONCLUSIONS: Compared with thermal ablation, PFA more often resulted in an AA burden less than the clinically significant threshold of 0.1% burden. (The FARAPULSE ADVENT PIVOTAL Trial PFA System vs SOC Ablation for Paroxysmal Atrial Fibrillation [ADVENT]; NCT04612244).


Subject(s)
Atrial Fibrillation , Catheter Ablation , Recurrence , Humans , Atrial Fibrillation/surgery , Atrial Fibrillation/therapy , Atrial Fibrillation/physiopathology , Male , Female , Middle Aged , Catheter Ablation/methods , Aged , Quality of Life , Treatment Outcome
17.
Heart Rhythm ; 2024 May 31.
Article in English | MEDLINE | ID: mdl-38823667

ABSTRACT

BACKGROUND: Atrial fibrillation (AF) ablation carries the risk of silent cerebral event (SCE) and silent cerebral lesion (SCL). Although "silent," these may have long-term clinical implications and are challenging to study as postprocedural magnetic resonance imaging (MRI) is not standard of care. OBJECTIVE: The neurological assessment subgroup (NAS) of ADVENT compared cerebral effects of pulsed field ablation (PFA) with standard-of-care thermal ablation. METHODS: The NAS included consecutive randomized PFA and thermal ablation patients who received postprocedural brain MRI 12-48 hours after ablation. Patients with apparent SCE or SCL findings underwent a modified Rankin scale assessment. MRI images were subsequently reviewed by a blinded brain imaging core laboratory. RESULTS: In total, 77 patients with paroxysmal AF were enrolled at 6 centers; 71 had analyzable scans (34 PFA; 37 thermal ablation). Through individual center review, 6 PFA and 4 thermal scans were identified as SCE/SCL positive, of which 3 PFA and 0 thermal SCE/SCL findings were confirmed by a blinded core laboratory. MRI findings revealed 1 patient with 2- to 4-mm SCEs, 1 patient with a 3-mm SCE, and 1 patient with 2 SCLs (5.5 mm and 11 mm). All modified Rankin scale and National Institutes of Health Stroke Scale scores were 0 before discharge and at 90-day follow-up. There were only 2 neurological safety events (1 transient ischemic attack [PFA] and 1 stroke [thermal ablation]) in the ADVENT study, neither of which was part of the NAS. CONCLUSION: The ADVENT trial provides the first prospective, randomized data on the cerebral impact of PFA and thermal ablation of AF. Incidence of SCE/SCL after ablation in the NAS was low.

18.
Europace ; 26(7)2024 Jul 02.
Article in English | MEDLINE | ID: mdl-38912887

ABSTRACT

AIMS: Pulsed field ablation (PFA) is an emerging non-thermal ablative modality demonstrating considerable promise for catheter ablation of atrial fibrillation (AF). However, these PFA trials have almost universally included only Caucasian populations, with little data on its effect on other races/ethnicities. The PLEASE-AF trial sought to study the 12-month efficacy and the safety of a multi-electrode hexaspline PFA catheter in treating a predominantly Asian/Chinese population of patients with drug-refractory paroxysmal AF. METHODS AND RESULTS: Patients underwent pulmonary vein (PV) isolation (PVI) by delivering different pulse intensities at the PV ostium (1800 V) and atrium (2000 V). Acute success was defined as no PV potentials and entrance/exit conduction block of all PVs after a 20-min waiting period. Follow-up at 3, 6, and 12 months included 12-lead electrocardiogram and 24-h Holter examinations. The primary efficacy endpoint was 12-month freedom from any atrial arrhythmias lasting at least 30 s. The cohort included 143 patients from 12 hospitals treated by 28 operators: age 60.2 ± 10.0 years, 65.7% male, Asian/Chinese 100%, and left atrial diameter 36.6 ± 4.9 mm. All PVs (565/565, 100%) were successfully isolated. The total procedure, catheter dwell, total PFA application, and total fluoroscopy times were 123.5 ± 38.8 min, 63.0 ± 30.7 min, 169.7 ± 34.6 s, and 27.3 ± 10.1 min, respectively. The primary endpoint was observed in 124 of 143 patients (86.7%). One patient (0.7%) developed a small pericardial effusion 1-month post-procedure, not requiring intervention. CONCLUSION: The novel hexaspline PFA catheter demonstrated universal acute PVI with an excellent safety profile and promising 12-month freedom from recurrent atrial arrhythmias in an Asian/Chinese population with paroxysmal AF. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT05114954.


Subject(s)
Atrial Fibrillation , Catheter Ablation , Pulmonary Veins , Humans , Atrial Fibrillation/surgery , Atrial Fibrillation/physiopathology , Atrial Fibrillation/diagnosis , Male , Female , Middle Aged , Catheter Ablation/methods , Catheter Ablation/adverse effects , Pulmonary Veins/surgery , Pulmonary Veins/physiopathology , Aged , Treatment Outcome , Asian People , China , Cardiac Catheters , Recurrence , Electrocardiography, Ambulatory , Time Factors , Equipment Design , Heart Rate , Action Potentials
19.
Article in English | MEDLINE | ID: mdl-38852101

ABSTRACT

BACKGROUND: Hemolysis-related renal failure has been described after pulmonary vein isolation (PVI) with pulsed-field ablation (PFA). OBJECTIVES: This study sought to compare the potential for hemolysis during PVI with PFA vs radiofrequency ablation (RFA). METHODS: In consecutive patients, PVI was performed with PFA or RFA. Blood samples were drawn at baseline, immediately postablation, and 24 hours postablation. Using flow cytometry, the concentration of red blood cell microparticles (RBCµ) (fragments of damaged erythrocytes) in blood was assessed. Lactate dehydrogenase (LDH), haptoglobin, and indirect bilirubin were measured at baseline and 24 hours. RESULTS: Seventy patients (age: 64.7 ± 10.2 years; 47% women; 36 [51.4%] paroxysmal atrial fibrillation) were enrolled: 47 patients were in the PFA group (22 PVI-only and 36.4 ± 5.5 PFA applications; 25 PVI-plus, 67.3 ± 12.4 pulsed field energy applications), and 23 patients underwent RFA. Compared to baseline, the RBCµ concentration increased ∼12-fold postablation and returned to baseline by 24 hours in the PFA group (median: 70.8 [Q1-Q3: 51.8-102.5] vs 846.6 [Q1-Q3: 639.2-1,215.5] vs 59.3 [Q1-Q3: 42.9-86.5] RBCµ/µL, respectively; P < 0.001); this increase was greater with PVI-plus compared to PVI-only (P = 0.007). There was also a significant, albeit substantially smaller, periprocedural increase in RBCµ with RFA (77.7 [Q1-Q3: 39.2-92.0] vs 149.6 [Q1-Q3: 106.6-180.8] vs 89.0 [Q1-Q3: 61.2-123.4] RBCµ/µL, respectively; P < 0.001). At 24 hours with PFA, the concentration of LDH and indirect bilirubin increased, whereas haptoglobin decreased significantly (all P < 0.001). In contrast, with RFA, there were only smaller changes in LDH and haptoglobin concentrations (P = 0.03) and no change in bilirubin. CONCLUSIONS: PFA was associated with significant periprocedural hemolysis. With a number of 70 PFA lesions, the likelihood of significant renal injury is uncommon.

20.
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.

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