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1.
N Engl J Med ; 389(15): 1380-1389, 2023 Oct 12.
Article in English | MEDLINE | ID: mdl-37634135

ABSTRACT

BACKGROUND: The role of catheter ablation in patients with symptomatic atrial fibrillation and end-stage heart failure is unknown. METHODS: We conducted a single-center, open-label trial in Germany that involved patients with symptomatic atrial fibrillation and end-stage heart failure who were referred for heart transplantation evaluation. Patients were assigned to receive catheter ablation and guideline-directed medical therapy or medical therapy alone. The primary end point was a composite of death from any cause, implantation of a left ventricular assist device, or urgent heart transplantation. RESULTS: A total of 97 patients were assigned to the ablation group and 97 to the medical-therapy group. The trial was stopped for efficacy by the data and safety monitoring board 1 year after randomization was completed. Catheter ablation was performed in 81 of 97 patients (84%) in the ablation group and in 16 of 97 patients (16%) in the medical-therapy group. After a median follow-up of 18.0 months (interquartile range, 14.6 to 22.6), a primary end-point event had occurred in 8 patients (8%) in the ablation group and in 29 patients (30%) in the medical-therapy group (hazard ratio, 0.24; 95% confidence interval [CI], 0.11 to 0.52; P<0.001). Death from any cause occurred in 6 patients (6%) in the ablation group and in 19 patients (20%) in the medical-therapy group (hazard ratio, 0.29; 95% CI, 0.12 to 0.72). Procedure-related complications occurred in 3 patients in the ablation group and in 1 patient in the medical-therapy group. CONCLUSIONS: Among patients with atrial fibrillation and end-stage heart failure, the combination of catheter ablation and guideline-directed medical therapy was associated with a lower likelihood of a composite of death from any cause, implantation of a left ventricular assist device, or urgent heart transplantation than medical therapy alone. (Funded by Else Kröner-Fresenius-Stiftung; CASTLE-HTx ClinicalTrials.gov number, NCT04649801.).


Subject(s)
Atrial Fibrillation , Catheter Ablation , Heart Failure , Humans , Anti-Arrhythmia Agents/therapeutic use , Atrial Fibrillation/complications , Atrial Fibrillation/surgery , Catheter Ablation/adverse effects , Catheter Ablation/methods , Germany , Heart Failure/complications , Heart Failure/surgery , Heart Transplantation , Heart-Assist Devices , Referral and Consultation , Treatment Outcome
2.
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
3.
Cardiovasc Diabetol ; 23(1): 78, 2024 02 24.
Article in English | MEDLINE | ID: mdl-38402177

ABSTRACT

OBJECTIVE: We aimed to assess the effect of SGLT2i on arrhythmias by conducting a meta-analysis using data from randomized controlled trials(RCTs). BACKGROUND: Sodium-glucose co-transporter 2 inhibitors (SGLT2i) have shown cardioprotective effects via multiple mechanisms that may also contribute to decrease arrhythmias risk. METHODS: We searched in databases (PubMed, Embase, Cochrane Library, and clinicaltrials.gov) up to April 2023. RCTs comparing SGLT2i with placebo were included. The effects of SGLT2i on atrial fibrillation(AF), atrial flutter(AFL), composite AF/AFL, ventricular fibrillation(VF), ventricular tachycardia(VT), ventricular extrasystoles(VES), sudden cardiac death(SCD) and composite VF/VT/SCD were evaluated. RESULTS: 33 placebo-controlled RCTs were included, comprising 88,098 patients (48,585 in SGLT2i vs. 39,513 in placebo). The mean age was 64.9 ± 9.4 years, 63.0% were male. The mean follow-up was 1.4 ± 1.1 years. The pooled-results showed that SGLT2i was associated with a significantly lower risk of AF [risk ratio(RR): 0.88, 95% confidence interval(CI) 0.78-1.00, P = 0.04] and composite AF/AFL (RR: 0.86, 95%CI 0.77-0.96, P = 0.01). This favorable effect appeared to be substantially pronounced in patients with HFrEF, male gender, dapagliflozin, and > 1 year follow-up. For SCD, only in heart failure patients, SGLT2i were found to be associated with a borderline lower risk of SCD (RR: 0.67, P = 0.05). No significant effects of SGLT2i on other ventricular arrhythmic outcomes were found. CONCLUSIONS: SGLT2i lowers the risks of AF and AF/AFL, and this favorable effect appeared to be particularly pronounced in patients with HFrEF, male gender, dapagliflozin, and longer follow-up (> 1 year). SGLT2i lowers the risk of SCD only in heart failure patients.


Subject(s)
Atrial Fibrillation , Benzhydryl Compounds , Glucosides , Heart Failure , Sodium-Glucose Transporter 2 Inhibitors , Humans , Male , Middle Aged , Aged , Female , Sodium-Glucose Transporter 2 Inhibitors/adverse effects , Stroke Volume , Death, Sudden, Cardiac/etiology , Death, Sudden, Cardiac/prevention & control , Ventricular Fibrillation
4.
Europace ; 26(3)2024 Mar 01.
Article in English | MEDLINE | ID: mdl-38516791

ABSTRACT

AIMS: Pulmonary vein isolation (PVI) for catheter ablation of atrial fibrillation (AF) is a time-demanding procedure. High-power short-duration (HPSD) ablation protocols and high-density mapping catheters have recently been introduced to clinical practice. We investigated the impact of high-density mapping and HPSD ablation protocols on procedural timing, efficacy, and safety by comparing different standardized set-ups. METHODS AND RESULTS: Three electrophysiology (EP) laboratory set-ups were analysed: (i) circular catheter for mapping and HPSD ablation with 30/35 W guided by an ablation index (AI); (ii) pentaspline catheter for mapping an HPSD ablation with 50 W guided by an AI; and (iii) pentaspline catheter for mapping and HPSD ablation with 90 W over 4 s using a novel ablation catheter. All patients underwent PVI without additional left atrial ablation strategies. Procedural data and operating intervals in the EP laboratory were systematically analysed. Three hundred seven patients were analysed (30/35 W AI: n = 102, 50 W AI: n = 102, 90 W/4 s: n = 103). Skin-to-skin times [105.3 ± 22.7 (30/35 W AI) vs. 81.4 ± 21.3 (50 W AI) vs. 69.5 ± 12.2 (90 W/4 s) min, P ≤ 0.001] and total laboratory times (132.8 ± 42.1 vs. 107.4 ± 25.7 vs. 95.2 ± 14.0 min, P < 0.001) significantly differed among the study groups. Laboratory interval analysis revealed significant shortening of mapping and ablation times. Arrhythmia-free survival after 12 months was not different among the study groups (log-rank P = 0.96). CONCLUSION: The integration of high-density mapping and HPSD protocols into an institutional AF ablation process resulted in reduced procedure times without compromising safety or efficacy.


Subject(s)
Atrial Appendage , Atrial Fibrillation , Catheter Ablation , Pulmonary Veins , Humans , Atrial Fibrillation/diagnosis , Atrial Fibrillation/surgery , Workflow , Heart Atria , Catheter Ablation/adverse effects , Pulmonary Veins/surgery , Treatment Outcome , Recurrence
5.
Europace ; 26(3)2024 Mar 01.
Article in English | MEDLINE | ID: mdl-38385529

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).


Subject(s)
Atrial Fibrillation , Catheter Ablation , Fistula , Pulmonary Veins , Female , Humans , Male , Anti-Arrhythmia Agents , Atrial Fibrillation/surgery , Catheter Ablation/methods , Constriction, Pathologic/surgery , Fistula/surgery , Prospective Studies , Pulmonary Veins/surgery , Recurrence , Tachycardia/surgery , Treatment Outcome , Middle Aged , Aged
6.
Europace ; 2024 Jun 28.
Article in English | MEDLINE | ID: mdl-38940494

ABSTRACT

AIMS: To describe the rationale, design, delivery and baseline characteristics of STEEER-AF (Stroke prevention and rhythm control Treatment: Evaluation of an Educational programme of the European Society of Cardiology [ESC] in a cluster-Randomised trial in patients with Atrial Fibrillation). METHODS & RESULTS: STEEER-AF is a pragmatic trial designed to objectively and robustly determine whether guidelines are adhered to in routine practice, and evaluate a targeted educational programme for healthcare professionals. Seventy centres were randomised in 6 countries (France, Germany, Italy, Poland, Spain and United Kingdom; 2022-2023). STEEER-AF centres recruited 1732 patients with a diagnosis of atrial fibrillation (AF), with mean age 68.9 years (SD 11.7), CHA2DS2-VASc score 3.2 (SD 1.8) and 647 (37%) women. 843 patients (49%) were in AF and 760 (44%) in sinus rhythm at enrolment. Oral anticoagulant therapy was prescribed in 1,543 patients (89%), with the majority receiving direct oral anticoagulants (1,378; 89%). Previous cardioversion, antiarrhythmic drug therapy or ablation was recorded in 836 patients (48.3%). 551 patients (31.8%) were currently receiving an antiarrhythmic drug, and 446 (25.8%) were scheduled to receive a future cardioversion or ablation. The educational programme engaged 195 healthcare professionals across centres randomised to the intervention group, consisting of bespoke interactive online learning and reinforcement activities, supported by national expert trainers. CONCLUSION: The STEEER-AF trial was successfully deployed across six European countries to investigate guideline adherence in real-world practice, and evaluate if a structured educational programme for healthcare professionals can improve patient-level care. REGISTRATION: Clinicaltrials.gov NCT04396418.

7.
Europace ; 26(5)2024 05 02.
Article in English | MEDLINE | ID: mdl-38743765

ABSTRACT

Imaging using cardiac computed tomography (CT) or magnetic resonance (MR) imaging has become an important option for anatomic and substrate delineation in complex atrial fibrillation (AF) and ventricular tachycardia (VT) ablation procedures. Computed tomography more common than MR has been used to detect procedure-associated complications such as oesophageal, cerebral, and vascular injury. This clinical consensus statement summarizes the current knowledge of CT and MR to facilitate electrophysiological procedures, the current value of real-time integration of imaging-derived anatomy, and substrate information during the procedure and the current role of CT and MR in diagnosing relevant procedure-related complications. Practical advice on potential advantages of one imaging modality over the other is discussed for patients with implanted cardiac rhythm devices as well as for planning, intraprocedural integration, and post-interventional management in AF and VT ablation patients. Establishing a team of electrophysiologists and cardiac imaging specialists working on specific details of imaging for complex ablation procedures is key. Cardiac magnetic resonance (CMR) can safely be performed in most patients with implanted active cardiac devices. Standard procedures for pre- and post-scanning management of the device and potential CMR-associated device malfunctions need to be in place. In VT patients, imaging-specifically MR-may help to determine scar location and mural distribution in patients with ischaemic and non-ischaemic cardiomyopathy beyond evaluating the underlying structural heart disease. Future directions in imaging may include the ability to register multiple imaging modalities and novel high-resolution modalities, but also refinements of imaging-guided ablation strategies are expected.


Subject(s)
Consensus , Magnetic Resonance Imaging , Tomography, X-Ray Computed , Humans , Catheter Ablation , Electrophysiologic Techniques, Cardiac , Tachycardia, Ventricular/surgery , Tachycardia, Ventricular/diagnostic imaging , Atrial Fibrillation/surgery , Atrial Fibrillation/diagnostic imaging , Atrial Fibrillation/physiopathology , Predictive Value of Tests , Europe , Treatment Outcome
8.
Europace ; 26(5)2024 May 02.
Article in English | MEDLINE | ID: mdl-38647070

ABSTRACT

AIMS: Simplified ablation technologies for pulmonary vein isolation (PVI) are increasingly performed worldwide. One of the most common complications following PVI are vascular access-related complications. Lately, venous closure systems (VCSs) were introduced into clinical practice, aiming to reduce the time of bed rest, to increase the patients' comfort, and to reduce vascular access-related complications. The aim of the present study is to compare the safety and efficacy of using a VCS to achieve haemostasis following single-shot PVI to the actual standard of care [figure-of-eight suture and manual compression (MC)]. METHODS AND RESULTS: This is a prospective, multicentre, randomized, controlled, open-label trial performed at three German centres. Patients were randomized 1:1 to undergo haemostasis either by means of VCS (VCS group) or of a figure-of-eight suture and MC (F8 group). The primary efficacy endpoint was the time to ambulation, while the primary safety endpoint was the incidence of major periprocedural adverse events until hospital discharge. A total of 125 patients were randomized. The baseline characteristics were similar between the groups. The VCS group showed a shorter time to ambulation [109.0 (82.0, 160.0) vs. 269.0 (243.8, 340.5) min; P < 0.001], shorter time to haemostasis [1 (1, 2) vs. 5 (2, 10) min; P < 0.001], and shorter time to discharge eligibility [270 (270, 270) vs. 340 (300, 458) min; P < 0.001]. No major vascular access-related complication was reported in either group. A trend towards a lower incidence of minor vascular access-related complications on the day of procedure was observed in the VCS group [7 (11.1%) vs. 15 (24.2%); P = 0.063] as compared to the control group. CONCLUSION: Following AF ablation, the use of a VCS results in a significantly shorter time to ambulation, time to haemostasis, and time to discharge eligibility. No major vascular access-related complications were identified. The use of MC and a figure-of-eight suture showed a trend towards a higher incidence of minor vascular access-related complications.


Subject(s)
Atrial Fibrillation , Catheter Ablation , Pulmonary Veins , Suture Techniques , Humans , Atrial Fibrillation/surgery , Female , Male , Middle Aged , Catheter Ablation/adverse effects , Catheter Ablation/methods , Prospective Studies , Pulmonary Veins/surgery , Suture Techniques/adverse effects , Aged , Treatment Outcome , Germany , Time Factors , Vascular Closure Devices , Early Ambulation , Hemostatic Techniques/instrumentation
9.
J Cardiovasc Electrophysiol ; 34(4): 833-840, 2023 04.
Article in English | MEDLINE | ID: mdl-36786515

ABSTRACT

INTRODUCTION: Pulmonary vein isolation (PVI) is well established as a primary treatment for atrial fibrillation (AF). The POLAR ICE study was designed to collect prospective real world data on the safety and effectiveness of the POLARxTM cryoballoon for PVI to treat paroxysmal AF. METHODS: POLAR ICE, a prospective, non-randomized, multicenter (international) registry (NCT04250714), enrolled 399 patients across 19 European centers. Procedural characteristics, such as time to isolation, cryoablations per pulmonary vein (PV), balloon nadir temperature, and occlusion grade were recorded. PVI was confirmed with entrance block testing. RESULTS: Data on 372 de novo PVI procedures (n = 2190 ablations) were collected. Complete PVI was achieved in 96.8% of PVs. Procedure and fluoroscopy times were 68.2 ± 24.6 and 15.6 ± 9.6 min, respectively. Left atrial dwell time was 46.6 ± 18.3 min. Grade 3 or 4 occlusion was achieved in 98.2% of PVs reported and 71.2% of PVs isolation required only a single cryoablation. Of 2190 cryoapplications, 83% had a duration of at least 120 s; nadir temperature of these ablations averaged -56.3 ± 6.5°C. There were 6 phrenic nerve palsy events, 2 of which resolved within 3 months of the procedure. CONCLUSION: This real-world usage data on a novel cryoballoon suggests this device is effective, safe, and relatively fast in centers with cryoballoon experience. These data are comparable to prior POLARx reports and in keeping with reported data on other cryoballoons. Future studies should examine the long-term outcomes and the relationship between biophysical parameters and outcomes for this novel cryoballoon.


Subject(s)
Atrial Fibrillation , Humans , Atrial Fibrillation/surgery , Prospective Studies , Treatment Outcome , Heart Atria , Fluoroscopy
10.
Europace ; 25(7)2023 07 04.
Article in English | MEDLINE | ID: mdl-37410906

ABSTRACT

Interventional electrophysiology offers a great variety of treatment options to patients suffering from symptomatic cardiac arrhythmia. Catheter ablation of supraventricular and ventricular tachycardia has globally evolved a cornerstone in modern arrhythmia management. Complex interventional electrophysiological procedures engaging multiple ablation tools have been developed over the past decades. Fluoroscopy enabled interventional electrophysiologist throughout the years to gain profound knowledge on intracardiac anatomy and catheter movement inside the cardiac cavities and hence develop specific ablation approaches. However, the application of X-ray technologies imposes serious health risks to patients and operators. To reduce the use of fluoroscopy during interventional electrophysiological procedures to the possibly lowest degree and to establish an optimal protection of patients and operators in cases of fluoroscopy is the main goal of modern radiation management. The present manuscript gives an overview of possible strategies of fluoroscopy reduction and specific radiation protection strategies.


Subject(s)
Catheter Ablation , Radiation Exposure , Humans , Arrhythmias, Cardiac/therapy , Cardiac Electrophysiology , Electrophysiologic Techniques, Cardiac , Fluoroscopy/methods , Radiation Dosage , Radiation Exposure/adverse effects
11.
Europace ; 25(9)2023 08 02.
Article in English | MEDLINE | ID: mdl-37622589

ABSTRACT

This article will discuss the past, present, and future of ventricular tachycardia ablation and the continuing contribution of the Europace journal as the platform for publication of milestone research papers in this field of ventricular tachycardia ablation.


Subject(s)
Catheter Ablation , Tachycardia, Ventricular , Humans , Tachycardia, Ventricular/diagnosis , Tachycardia, Ventricular/surgery , Catheter Ablation/adverse effects
12.
Europace ; 25(1): 74-82, 2023 02 08.
Article in English | MEDLINE | ID: mdl-36056882

ABSTRACT

AIMS: REDO-FIRM evaluated safety and effectiveness of conventional vs. focal impulse and rotor modulation (FIRM)-guided ablation of recurrent persistent or paroxysmal atrial fibrillation (AF) after an initial AF ablation procedure. METHODS AND RESULTS: This prospective, multicentre, randomized study included patients with a single prior AF ablation, but with recurrent AF and reconnected pulmonary veins (PVs). Conventional ablation generally included PV re-isolation; however, additional ablation was permitted per physician discretion. In the FIRM arm, beyond PV re-isolation, basket catheter-based FIRM mapping created dynamic animations of putative rotors, which were targeted for ablation. Between May 2016 and July 2019, 269 subjects were randomized, with 243 subjects completing 12-month follow-up. Ablation beyond re-pulmonary vein isolation, the FIRM vs. Conventional arms did not differ significantly: cavo-tricuspid isthmus -9.0% vs. 15.3%, caval vein isolation -1.5% vs. 0.8%, non-PV trigger -2.2% vs. 3.8%, other -11.9% vs. 13.0%. Single procedure 12-month freedom from AF/atrial tachycardia/atrial flutter-recurrence was 63.3% (76/120) vs. 59.0% (72/122) in the FIRM and Conventional arms (P = 0.3503). Efficacy was similar in the paroxysmal and persistent AF subgroups (P = 0.22 and P = 0.48). The 10-day and 12-month safety endpoints were achieved in 93.3% vs. 93.8% (P = 0.89) and 88.4% vs. 93.4% (P = 0.22) in the FIRM and Conventional arms, respectively. CONCLUSIONS: In REDO-FIRM, as compared to standard ablation, FIRM-guided ablation did not provide additional efficacy in redo ablation procedures, but FIRM-guided ablation was equally safe. Additional studies are necessary to identify any potential population able to benefit from FIRM-guided ablation.


Subject(s)
Atrial Fibrillation , Atrial Flutter , Catheter Ablation , Pulmonary Veins , Humans , Atrial Fibrillation/diagnosis , Atrial Fibrillation/surgery , Treatment Outcome , Prospective Studies , Pulmonary Veins/surgery , Catheter Ablation/adverse effects , Catheter Ablation/methods , Recurrence
13.
Europace ; 25(4): 1392-1399, 2023 04 15.
Article in English | MEDLINE | ID: mdl-36815300

ABSTRACT

AIMS: Atrial fibrillation (AF) ablation protocols using energy delivery with very high power and short duration (vHPSD) have been introduced to improve lesion formation. This study reports procedural data of vHPSD ablation in AF patients and analyses characteristics of ablation-induced left atrial (LA) scar formation from cardiac magnetic resonance imaging (MRI). METHODS AND RESULTS: Sixty consecutive patients undergoing index pulmonary vein isolation following our institutional Q4U-AF workflow were prospectively enrolled. Ablation was conducted using a contact force sensing catheter allowing for vHPSD ablation using a temperature-controlled ablation mode. Thirty patients underwent cardiac late gadolinium enhancement MRI of the LA 3 months after ablation to assess LA scar. Mean procedural duration was 66.5 ± 14.8 min. Mean ablation time was 4.7 ± 0.9 min with a mean number of 69.9 ± 14.2 applications. First-pass isolation was achieved in 51 patients (85%) for the right pulmonary veins (RPVs), in 37 patients (61.7%) for the left pulmonary veins (LPVs), and in 34 patients (56.7%) for both pulmonary veins (PVs). Magnetic resonance imaging at 3 months post-ablation demonstrated a mean scar width of 14.4 ± 2.6 mm around RPVs and 11.9 ± 1.9 mm at LPVs (P > 0.05). Complete PV encirclement was observed in 76.7% for RPVs, in 76.7% for LPVs, and in 66.7% for both PV pairs. During a mean follow-up of 4.7 ± 1.4 months, arrhythmia recurrence was observed in 3.3% of the patients. CONCLUSION: Pulmonary vein isolation following a novel vHPSD workflow resulted in short procedure duration and high acute and mid-term efficacy. Magnetic resonance imaging demonstrated durable and transmural PV lesions with homogeneous and contiguous scar formation.


Subject(s)
Atrial Fibrillation , Catheter Ablation , Pulmonary Veins , Humans , Atrial Fibrillation/diagnostic imaging , Atrial Fibrillation/surgery , Atrial Fibrillation/pathology , Contrast Media , Cicatrix/diagnostic imaging , Cicatrix/etiology , Cicatrix/pathology , Workflow , Gadolinium , Magnetic Resonance Imaging/methods , Catheter Ablation/adverse effects , Catheter Ablation/methods , Magnetic Resonance Spectroscopy , Pulmonary Veins/diagnostic imaging , Pulmonary Veins/surgery , Pulmonary Veins/pathology , Treatment Outcome , Recurrence
14.
Europace ; 25(9)2023 08 02.
Article in English | MEDLINE | ID: mdl-37470443

ABSTRACT

AIMS: Electro-anatomical mapping may be critical to identify atrial fibrillation (AF) subjects who require substrate modification beyond pulmonary vein isolation (PVI). The objective was to determine correlations between pre-ablation mapping characteristics and 12-month outcomes after a single PVI-only catheter ablation of AF. METHODS AND RESULTS: This study enrolled paroxysmal AF (PAF), early persistent AF (PsAF; 7 days-3 months), and non-early PsAF (>3-12 months) subjects undergoing de novo PVI-only radiofrequency catheter ablation. Sinus rhythm (SR) and AF voltage maps were created with the Advisor HD Grid™ Mapping Catheter, Sensor Enabled™ for each subject, and the presence of low-voltage area (LVA) (low-voltage cutoffs: 0.1-1.5 mV) was investigated. Follow-up visits were at 3, 6, and 12 months, with a 24-h Holter monitor at 12 months. A Cox proportional hazards model identified associations between mapping data and 12-month recurrence after a single PVI procedure. The study enrolled 300 subjects (113 PAF, 86 early PsAF, and 101 non-early PsAF) at 18 centres. At 12 months, 75.5% of subjects were free from AF/atrial flutter (AFL)/atrial tachycardia (AT) recurrence. Univariate analysis found that arrhythmia recurrence did not correlate with AF diagnosis, but LVA was significantly correlated. Low-voltage area (<0.5 mV) >28% of the left atrium in SR [hazard ratio (HR): 4.82, 95% confidence interval (CI): 2.08-11.18; P = 0.0003] and >72% in AF (HR: 5.66, 95% CI: 2.34-13.69; P = 0.0001) was associated with a higher risk of AF/AFL/AT recurrence at 12 months. CONCLUSION: Larger extension of LVA was associated with an increased risk of arrhythmia recurrence. These subjects may benefit from substrate modification beyond PVI.


Subject(s)
Atrial Fibrillation , Atrial Flutter , Catheter Ablation , Pulmonary Veins , Humans , Atrial Fibrillation/diagnosis , Atrial Fibrillation/surgery , Pulmonary Veins/surgery , Heart Rate , Treatment Outcome , Electrophysiologic Techniques, Cardiac , Recurrence , Time Factors , Heart Atria , Atrial Flutter/diagnosis , Atrial Flutter/surgery , Atrial Flutter/etiology , Catheter Ablation/adverse effects , Catheter Ablation/methods
15.
Europace ; 25(2): 600-609, 2023 02 16.
Article in English | MEDLINE | ID: mdl-36504238

ABSTRACT

AIMS: Accessory pathway (AP) ablation is a standard procedure for the treatment of Wolff-Parkinson-White syndrome (WPW). Twelve-lead electrocardiogram (ECG)-based delta wave analysis is essential for predicting ablation sites. Previous algorithms have shown to be complex, time-consuming, and unprecise. We aimed to retrospectively develop and prospectively validate a new, simple ECG-based algorithm considering the patients' heart axis allowing for exact localization of APs in patients undergoing ablation for WPW. METHODS AND RESULTS: Our multicentre study included 211 patients undergoing ablation of a single manifest AP due to WPW between 2013 and 2021. The algorithm was developed retrospectively and validated prospectively by comparing its efficacy to two established ones (Pambrun and Arruda). All patients (32 ± 19 years old, 47% female) underwent successful pathway ablation. Prediction of AP-localization was correct in 197 patients (93%) (sensitivity 92%, specificity 99%, PPV 96%, and NPV 99%). Our algorithm was particularly useful in correctly localizing antero-septal/-lateral (sensitivity and specificity 100%) and posteroseptal (sensitivity 98%, specificity 92%) AP in proximity to the tricuspid valve. The accuracy of EASY-WPW was superior compared to the Pambrun (93% vs. 84%, P = 0.003*) and the Arruda algorithm (94% vs. 75%, P < 0.001*). A subgroup analysis of children (n = 58, 12 ± 4 years old, 55% female) revealed superiority to the Arruda algorithm (P < 0.001*). The reproducibility of our algorithm was excellent (Ï°>0.8; P < 0.001*). CONCLUSION: The novel EASY-WPW algorithm provides reliable and accurate pre-interventional ablation site determination in WPW patients. Only two steps are necessary to locate left-sided AP, and three steps to determine right-sided AP.


Subject(s)
Accessory Atrioventricular Bundle , Catheter Ablation , Wolff-Parkinson-White Syndrome , Humans , Adult , Child , Female , Adolescent , Young Adult , Middle Aged , Male , Wolff-Parkinson-White Syndrome/diagnosis , Wolff-Parkinson-White Syndrome/surgery , Retrospective Studies , Reproducibility of Results , Catheter Ablation/methods , Accessory Atrioventricular Bundle/diagnosis , Accessory Atrioventricular Bundle/surgery , Electrocardiography/methods , Algorithms
16.
Europace ; 25(2): 374-381, 2023 02 16.
Article in English | MEDLINE | ID: mdl-36414239

ABSTRACT

AIMS: Cryoballoon (CB)-based pulmonary vein isolation (PVI) is an effective treatment for atrial fibrillation (AF). The most frequent complication during CB-based PVI is right-sided phrenic nerve injury (PNI) which is leading to premature abortion of the freeze cycle. Here, we analysed reconnection rates after CB-based PVI and PNI in a large-scale population during repeat procedures. METHODS AND RESULTS: In the YETI registry, a total of 17 356 patients underwent CB-based PVI in 33 centres, and 731 (4.2%) patients experienced PNI. A total of 111/731 (15.2%) patients received a repeat procedure for treatment of recurrent AF. In 94/111 (84.7%) patients data on repeat procedures were available. A total of 89/94 (94.7%) index pulmonary veins (PVs) have been isolated during the initial PVI. During repeat procedures, 22 (24.7%) of initially isolated index PVs showed reconnection. The use of a double stop technique did non influence the PV reconnection rate (P = 0.464). The time to PNI was 140.5 ± 45.1 s in patients with persistent PVI and 133.5 ± 53.8 s in patients with reconnection (P = 0.559). No differences were noted between the two populations in terms of CB temperature at the time of PNI (P = 0.362). The only parameter associated with isolation durability was CB temperature after 30 s of freezing. The PV reconnection did not influence the time to AF recurrence. CONCLUSION: In patients with cryoballon application abortion due to PNI, a high rate of persistent PVI rate was found at repeat procedures. Our data may help to identify the optimal dosing protocol in CB-based PVI procedures. CLINICAL TRIAL REGISTRATION: https://clinicaltrials.gov/ct2/show/NCT03645577?term=YETI&cntry=DE&draw=2&rank=1 ClinicalTrials.gov Identifier: NCT03645577.


Subject(s)
Atrial Fibrillation , Catheter Ablation , Cryosurgery , Pulmonary Veins , Humans , Atrial Fibrillation/diagnosis , Atrial Fibrillation/surgery , Atrial Fibrillation/etiology , Catheter Ablation/adverse effects , Cryosurgery/adverse effects , Cryosurgery/methods , Phrenic Nerve , Pulmonary Veins/surgery , Recurrence , Time Factors , Treatment Outcome
17.
Pacing Clin Electrophysiol ; 46(12): 1586-1594, 2023 12.
Article in English | MEDLINE | ID: mdl-37943015

ABSTRACT

Pulsed field ablation (PFA) is a promising technology for the treatment of atrial fibrillation (AF). Due to its unique tissue selectivity, PFA potentially bears superior characteristics as compared to established thermal energy sources in AF ablation procedures. Cardiovascular magnetic resonance imaging (CMR) using late gadolinium enhancement (LGE) is an established tool in the analysis of myocardial fibrosis representing atrial cardiomyopathy as well as ablation-induced atrial scar formation following catheter ablation with thermal energy. Mechanisms of atrial lesion formation differ between thermal ablation and electroporation and its impact on results of CMR imaging are not fully understood until now. In this review article, the potential of CMR imaging for PFA lesion assessment and available data are discussed. Further, additional needs to adopt imaging approaches to the cellular mechanisms of electroporation are considered.


Subject(s)
Atrial Fibrillation , Cardiomyopathies , Catheter Ablation , Humans , Atrial Fibrillation/diagnostic imaging , Atrial Fibrillation/surgery , Contrast Media , Gadolinium , Magnetic Resonance Imaging/methods , Heart Atria/diagnostic imaging , Heart Atria/surgery , Heart Atria/pathology , Cardiomyopathies/diagnostic imaging , Cardiomyopathies/surgery , Catheter Ablation/methods
18.
Pacing Clin Electrophysiol ; 46(7): 714-716, 2023 07.
Article in English | MEDLINE | ID: mdl-37247251

ABSTRACT

BACKGROUND: Pulsed field ablation (PFA) results in unique lesion formation, but there is lack of in-vivo validation in terms of scar formation following atrial fibrillation (AF) ablation. OBJECTIVE: We aimed to access atrial lesion formation based on late gadolinium enhancement (LGE) cardiovascular magnetic resonance imaging (CMR) following PFA for pulmonary vein (PV) and posterior wall isolation (PWI). METHODS: AF ablation was performed in 10 patients using a 31 mm pentaspline PFA catheter. After pulmonary vein isolation (PVI; n = 8 PFA-applications/ PV; n = 4 in basket and n = 4 in flower configuration), another eight applications in flower configuration were conducted for concomitant PWI. Patients underwent LGE CMR 3 months after ablation aiming for quantification of left atrial (LA) scar. RESULTS: Acute procedural success was achieved in all patients. Mean procedure duration was 62 ± 7 min. and mean LA dwell time of the PFA catheter was 13 ± 2 min. Mean post ablation total LA scar burden was 8.1 ± 2.1% and mean scar width was 12.8 ± 2.1 mm. At the posterior LA, 22.6 ± 2.2% of the anatomical segment resulted in chronic scar tissue, concentrated at the PW. Postablation CMR found no evidence for PV stenosis or collateral damage of adjacent structures. At 7 months of follow-up, 9/10 patients (90%) were free from arrhythmia recurrence. CONCLUSION: PFA for AF resulted in durable and transmural atrial scar tissue at the PVs and PW. LGE CMR found a very homogeneous and contiguous lesion pattern with no signs for collateral damage.


Subject(s)
Atrial Fibrillation , Catheter Ablation , Pulmonary Veins , Humans , Cicatrix/surgery , Contrast Media , Pulmonary Veins/surgery , Gadolinium , Heart Atria/diagnostic imaging , Heart Atria/surgery , Heart Atria/pathology , Catheter Ablation/methods , Treatment Outcome , Recurrence
19.
Pacing Clin Electrophysiol ; 46(12): 1553-1564, 2023 12.
Article in English | MEDLINE | ID: mdl-37885302

ABSTRACT

BACKGROUND: Targeting individual sources identified during atrial fibrillation (AF) has been used as an ablation strategy with varying results. OBJECTIVE: Aim of this study was to evaluate the relationship between regions of interest (ROIs) from CARTOFINDER (CF) mapping and atrial cardiomyopathy from late gadolinium enhancement (LGE) cardiovascular magnetic resonance imaging (CMR). METHODS: Twenty consecutive patients underwent index catheter ablation for persistent AF (PERS AF). Pre-processed LGE CMR images were merged with the results from CF mapping to visualize harboring regions for focal and rotational activities. Atrial cardiomyopathy was classified based on the four Utah stages. RESULTS: Procedural success was achieved in all patients (n = 20, 100%). LGE CMR revealed an intermediate amount of 21.41% ± 6.32% for LA fibrosis. ROIs were identified in all patients (mean no ROIs per patient n = 416.45 ± 204.57). A tendency towards a positive correlation between the total amount of atrial cardiomyopathy and the total number of ROIs per patient (regression coefficient, ß = 10.86, p = .15) was observed. The degree of fibrosis and the presence of ROIs per segment showed no consistent spatial correlation (posterior: ß = 0.36, p-value (p) = .24; anterior: ß = -0.08, p = .54; lateral: ß = 0.31, p = 39; septal: ß = -0.12; p = .66; right PVs: ß = 0.34, p = .27; left PVs: ß = 0.07, p = .79; LAA: ß = -0.91, p = .12). 12 months AF-free survival was 70% (n = 14) after ablation. CONCLUSION: The presence of ROIs from CF mapping was not directly associated with the extent and location of fibrosis. Further studies evaluating the relationship between focal and rotational activity and atrial cardiomyopathy are mandatory.


Subject(s)
Atrial Fibrillation , Cardiomyopathies , Catheter Ablation , Humans , Catheter Ablation/methods , Contrast Media , Fibrosis , Gadolinium , Heart Atria , Magnetic Resonance Imaging/methods
20.
Heart Vessels ; 38(7): 984-991, 2023 Jul.
Article in English | MEDLINE | ID: mdl-36786857

ABSTRACT

A new automated vector-based mapping algorithm (AMA) for 3-dimensional (3D) mapping has been introduced. The aim of this study was to present our experience using AMA to recognize additional catheter ablation targets in patients with ventricular arrhythmias (VA). A total of 16 patients (ICM; ischemic cardiomyopathy, n = 6; NICM; non-ischemic cardiomyopathy n = 10) suffering from VA underwent catheter ablation. Following bipolar voltage mapping, AMA was utilized to reveal zones of decelerated conduction velocity vectors (CVV) and this information was superimposed onto the 3D reconstructions and compared with the presence of scar. Mapping time was 28.1 ± 10 min for the endocardial reconstruction of the left ventricle (LV) and 17 ± 5.4 min for the epicardium (n = 6 patients). The mean area of LV low voltage was 13.9 ± 15% (endocardial) and 11.9 ± 5.7% (epicardial). Decelerating CVV zones were revealed in all patients (mean conduction velocity threshold of 39.3 ± 13%). Sustained VA have been terminated through ablation and substrate modification was performed in all patients. Correlation between the presence of CVV deceleration zones and areas of abnormal low voltage from bipolar mapping was revealed in only 37.5% of patients, but there was good correlation between scar from unipolar voltage mapping and the presence of CCV deceleration zones (94%; p = 0.008). The novel AMA may improve the understanding of individual VA substrates due to the visualization of decelerated CVV zones and their correlation with abnormal low voltage predominantly from unipolar mapping.


Subject(s)
Cardiomyopathies , Catheter Ablation , Tachycardia, Ventricular , Humans , Tachycardia, Ventricular/diagnosis , Tachycardia, Ventricular/surgery , Cicatrix/surgery , Heart Ventricles , Arrhythmias, Cardiac , Catheter Ablation/methods
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