Implantable loop recorders in patients with Brugada syndrome: the BruLoop study.

BACKGROUND AND AIMS: Available data on continuous rhythm monitoring by implantable loop recorders (ILRs) in patients with Brugada syndrome (BrS) are scarce. The aim of this multi-centre study was to evaluate the diagnostic yield and clinical implication of a continuous rhythm monitoring strategy by ILRs in a large cohort of BrS patients and to assess the precise arrhythmic cause of syncopal episodes. METHODS: A total of 370 patients with BrS and ILRs (mean age 43.5 ± 15.9, 33.8% female, 74.1% symptomatic) from 18 international centers were included. Patients were followed with continuous rhythm monitoring for a median follow-up of 3 years. RESULTS: During follow-up, an arrhythmic event was recorded in 30.7% of symptomatic patients [18.6% atrial arrhythmias (AAs), 10.2% bradyarrhythmias (BAs), and 7.3% ventricular arrhythmias (VAs)]. In patients with recurrent syncope, the aetiology was arrhythmic in 22.4% (59.3% BAs, 25.0% VAs, and 15.6% AAs). The ILR led to drug therapy initiation in 11.4%, ablation procedure in 10.9%, implantation of a pacemaker in 2.5%, and a cardioverter-defibrillator in 8%. At multivariate analysis, the presence of symptoms [hazard ratio (HR) 2.5, P = .001] and age >50 years (HR 1.7, P = .016) were independent predictors of arrhythmic events, while inducibility of ventricular fibrillation at the electrophysiological study (HR 9.0, P < .001) was a predictor of VAs. CONCLUSIONS: ILR detects arrhythmic events in nearly 30% of symptomatic BrS patients, leading to appropriate therapy in 70% of them. The most commonly detected arrhythmias are AAs and BAs, while VAs are detected only in 7% of cases. Symptom status can be used to guide ILR implantation.

One-year outcomes of pulmonary vein isolation with a novel cryoballoon: Primary results of the FROZEN AF trial.

INTRODUCTION: Cryoablation therapy for pulmonary vein isolation (PVI) to treat paroxysmal atrial fibrillation (PAF) is well established. A novel 28 mm cryoballoon system designed to operate under low pressure to safely reach a lower nadir temperature and maintain constant balloon size during cooling has not been prospectively studied in a large patient population for safety and efficacy. The FROZEN AF (NCT04133168) trial was an international multicenter, open-label, prospective, single-arm study on the safety and performance of a novel cryoballoon system for treatment of PAF. METHODS AND RESULTS: The study enrolled patients at 44 sites in 10 countries across North America, Europe, and Asia. Subjects were indicated for PVI treatment of PAF and had failed or were intolerant of one or more antiarrhythmic drugs. Procedural outcomes were defined based on the 2017 HRS consensus statement. Follow-up was performed at 7 days, 3, 6, and 12 months. Data are reported as mean ± SD or median (IQR). PVI was performed with a 28 mm cryoballoon in 325 drug refractory PAF patients. Complete PVI was achieved in 95.7% of patients. In cryoablation lesions longer than 60 s, 60.1% of PV isolations required only a single cryoballoon application. Procedure related complications included: phrenic nerve palsy [temporary 4 (1.2%), persistent 0 (0.0%)], cardiac tamponade/perforation 2 (0.6%), and air embolism 1 (0.3%). Freedom from documented atrial arrhythmia recurrence at 12 months was 79.9% (AF 82.7%, AFL 96.5%, AT 98.1%), antiarrhythmic drugs (AAD) were continued or re-initiated in 26.8% of patients after the 3-month blanking period. Additionally, an extension arm enrolled 50 pts for treatment with 28/31 mm variable size cryoballoon. A single temporary PNP occurred in this group, which resolved before discharge. Freedom from documented recurrence at 12 months in these pts was 82.0%. CONCLUSIONS: This novel cryoballoon may facilitate PVI to treat PAF, providing more options to address the variety of anatomies present in patients with PAF. This cryoballoon system proved to be safe and effective for treatment of patients with drug refractory or drug intolerant PAF.

Strategies to improve atrioventricular synchrony in patients with a Micra AV leadless pacemaker.

The second generation of transcatheter pacing systems, called Micra AV, can provide atrioventricular (AV) synchronous pacing via a new pacing algorithm relying on sensing mechanical atrial contraction. Several novel programming parameters were introduced to enable AV synchronous pacing, including an A3 window and A4 window as well as a conduction mode switch and an activity mode switch. In addition to several automated features, manual programming optimization of some of the novel parameters is key to improving AV synchrony. A solid knowledge of the features and their programming is essential for electrophysiologists implanting or following patients with Micra AV devices. Differences in programming optimization might partially explain the high variability of AV synchrony published in real-world data reports. This article reviews the key programming parameters of Micra AV. Subsequently, optimal programming recommendations for defined patient profiles are presented. Those were established by consensus within an expert panel comprised of 11 European electrophysiologists from high-volume Micra AV centres. The patient profiles were (1) high degree AV block and slow sinus rhythm; (2) high degree AV block and fast sinus rhythm; and (3) intermittent AV block. The panel recommended to evaluate the mechanical atrial activity on transthoracic echocardiography prior to implant. It was also agreed that Auto A3 Threshold and Tracking Check should be turned off in all patients, AV conduction mode switch should be turned off in all patients with high degree AV block, and the lower rate should be programmed to 50 bpm with exceptions based on individual clinical assessment. Future studies will be useful to evaluate the strength of those recommendations to improve the AV synchrony.

Left ventricular functional recovery after atrial fibrillation catheter ablation in heart failure: a prediction model.

AIMS: Management of patients with atrial fibrillation (AF) and concomitant heart failure (HF) remains complex. The Antwerp score, based on four parameters [QRS >120 ms (2 points), known aetiology (2 points), paroxysmal AF (1 point), severe atrial dilation (1 point)] adequately estimated the probability of left ventricular ejection fraction (LVEF) recovery after AF ablation in a single-centre cohort. The present study aims to externally validate this prediction model in a large European multi-centre cohort. METHODS AND RESULTS: A total of 605 patients (61.1 ± 9.4 years, 23.8% females, 79.8% with persistent AF) with HF and impaired LVEF (<50%) undergoing AF ablation in 8 European centres were retrospectively identified. According to the LVEF changes at 12-month echocardiography, 427 (70%) patients fulfilled the '2021 Universal Definition of HF' criteria for LVEF recovery and were defined as 'responders'. External validation of the score yielded good discrimination and calibration {area under the curve 0.86 [95% confidence interval (CI) 0.82-0.89], P < .001; Hosmer-Lemeshow P = .29}. Patients with a score < 2 had a 93% probability of LVEF recovery as opposed to only 24% in patients with a score > 3. Responders experienced more often positive ventricular remodelling [odds ratio (OR) 8.91, 95% CI 4.45-17.84, P < .001], fewer HF hospitalizations (OR 0.09, 95% CI 0.05-0.18, P < .001) and lower mortality (OR 0.11, 95% CI 0.04-0.31, P < .001). CONCLUSION: In this multi-centre study, a simple four-parameter score predicted LVEF recovery after AF ablation in patients with HF and discriminated clinical outcomes. These findings support the use of the Antwerp score to standardize shared decision-making regarding AF ablation referral in future clinical studies.

Quantitative assessment of transient autonomic modulation after single-shot pulmonary vein isolation with pulsed-field ablation.

INTRODUCTION: Pulmonary vein isolation (PVI) with thermal energy is characterized by concomitant ablation of the surrounding ganglionated plexi (GP). Pulsed-field ablation (PFA) selectively targets the myocardium and seems associated with only negligible effects on the autonomic nervous system (ANS). However, little is known about the dynamic effects of PFA on the GP immediately after PVI. This study sought to investigate the degree and acute vagal modulation induced by the FarapulseTM PFA system during PVI compared with single-shot thermal ablation. METHODS: A total of 76 patients underwent first-time PVI with either FarapulseTM PFA (PFA group, n = 40) or cryoballoon ablation (thermal ablation group, n = 36) for paroxysmal atrial fibrillation (AF). The effect on the ANS in the two groups was assessed before and after PVI with extracardiac vagal stimulation (ECVS). To capture any transient effects of PFA on the ANS, in a subgroup of PFA patients ECVS was repeated at three predefined timepoints: (1) before PVI (T0); (2) immediately after PVI (T1); and (3) 10 min after the last energy application (T2). RESULTS: Despite similar baseline values, the vagal response induced by ECVS after PVI almost disappeared in the thermal ablation group but persisted in the PFA group (thermal group: 840 [706-1090] ms, p < .001 compared to baseline; PFA group: 11 466 [8720-12 293] ms, p = .70 compared to baseline). Intraprocedural vagal reactions (defined as RR increase >50%, transitory asystole, or atrioventricular block) occurred more frequently with PFA than thermal ablation (70% vs. 28%, p = .001). Moreover, heart rate 24 h post-PVI increased more with thermal ablation than with PFA (16.5 ± 9.0 vs. 2.6 ± 6.1 beats/min, p < .001). In the subgroup of PFA patients undergoing repeated ANS modulation assessment (n = 11), ECVS demonstrated that PFA determined a significant acute suppression of the vagal response immediately after PVI (p < .001 compared to baseline), which recovered almost completely within 10 min. CONCLUSION: PVI with the FarapulseTM PFA system is associated with only transitory and short-lasting vagal effects on the ANS which recover almost completely within a few minutes after ablation. The impact of this phenomenon on AF outcome needs to be further investigated.

Acute procedural efficacy and safety of a novel cryoballoon for the treatment of paroxysmal atrial fibrillation: Results from the POLAR ICE study.

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.

"Function follows form": Role of cardiac magnetic resonance for ventricular arrhythmia risk stratification in patients with cardiac sarcoidosis.

INTRODUCTION: Cardiac involvement is common and may become clinically relevant in approximately 5%-10% of patients with systemic sarcoidosis. Although reduced left ventricular ejection fraction is a recognized predictor of mortality, recent studies have suggested an increased risk of ventricular arrhythmia (VAs) and sudden cardiac death (SCD) in patients with cardiac sarcoidosis (CS) and evidence of late gadolinium enhancement-cardiac magnetic resonance (LGE-CMR), irrespective of the underlying left ventricular systolic function. We performed a meta-analysis to assess the correlation between VAs/SCD and presence of LGE-CMR in CS patients. METHODS: We systematically searched Medline, Embase, and Cochrane electronic databases up to January 2, 2023, for studies enrolling patients with suspected or confirmed CS undergoing LGE-CMR. Clinical outcomes of interest included clinically relevant VAs, defined as sustained ventricular tachycardia, ventricular fibrillation, SCD, or aborted SCD during follow-up. The effect size was estimated using a random-effect model as risk ratio (RR) and relative 95% confidence interval (CI). RESULTS: A total of 14 studies fulfilled the selection criteria and were included in the final analysis. Among 1273 patients, LGE was detected in 465 (36.5%; Group LGE+). Males accounted for 45.2% (95% CI: 40.5%-55.7%) of the total population and the average age was 56.8 (95% CI: 52.7%-60.9) years. A total of 104 (22.3%) of 465 LGE+ patients experienced a clinically relevant VA, compared to 6 (0.7%) of 808 LGE- ones. LGE+ was associated with a ninefold increased risk in life-threatening VAs (22.3% vs. 0.7%; RR = 9.52; 95% CI [5.18-17.49]; p < .0001) compared to patients without LGE (heterogeneity I2 = 0%). CONCLUSION: In our meta-analysis, LGE+ in patients with CS was associated with a ninefold increased risk in life-threatening VAs compared to patients without LGE.

Added value of patient- and drug-related factors to stratify drug-drug interaction alerts for risk of QT prolongation: Development and validation of a risk prediction model.

AIMS: Many clinical decision support systems trigger warning alerts for drug-drug interactions potentially leading to QT prolongation and torsades de pointes (QT-DDIs). Unfortunately, there is overalerting and underalerting because stratification is only based on a fixed QT-DDI severity level. We aimed to improve QT-DDI alerting by developing and validating a risk prediction model considering patient- and drug-related factors. METHODS: We fitted 31 predictor candidates to a stepwise linear regression for 1000 bootstrap samples and selected the predictors present in 95% of the 1000 models. A final linear regression model with those variables was fitted on the original development sample (350 QT-DDIs). This model was validated on an external dataset (143 QT-DDIs). Both true QTc and predicted QTc were stratified into three risk levels (low, moderate and high). Stratification of QT-DDIs could be appropriate (predicted risk = true risk), acceptable (one risk level difference) or inappropriate (two risk levels difference). RESULTS: The final model included 11 predictors with the three most important being use of antiarrhythmics, age and baseline QTc. Comparing current practice to the prediction model, appropriate stratification increased significantly from 37% to 54% appropriate QT-DDIs (increase of 17.5% on average [95% CI +5.4% to +29.6%], padj = 0.006) and inappropriate stratification decreased significantly from 13% to 1% inappropriate QT-DDIs (decrease of 11.2% on average [95% CI -17.7% to -4.7%], padj ≤ 0.001). CONCLUSION: The prediction model including patient- and drug-related factors outperformed QT alerting based on QT-DDI severity alone and therefore is a promising strategy to improve DDI alerting.

Twenty-five years of research in cardiac imaging in electrophysiology procedures for atrial and ventricular arrhythmias.

Catheter ablation is nowadays considered the treatment of choice for numerous cardiac arrhythmias in different clinical scenarios. Fluoroscopy has traditionally been the primary imaging modality for catheter ablation, providing real-time visualization of catheter navigation. However, its limitations, such as inadequate soft tissue visualization and exposure to ionizing radiation, have prompted the integration of alternative imaging modalities. Over the years, advancements in imaging techniques have played a pivotal role in enhancing the safety, efficacy, and efficiency of catheter ablation procedures. This manuscript aims to explore the utility of imaging, including electroanatomical mapping, cardiac computed tomography, echocardiography, cardiac magnetic resonance, and nuclear cardiology exams, in helping electrophysiology procedures. These techniques enable accurate anatomical guidance, identification of critical structures and substrates, and real-time monitoring of complications, ultimately enhancing procedural safety and success rates. Incorporating advanced imaging technologies into routine clinical practice has the potential to further improve clinical outcomes of catheter ablation procedures and pave the way for more personalized and precise ablation therapies in the future.

Contemporary management of ventricular electrical storm in Europe: results of a European Heart Rhythm Association Survey.

Electrical storm (ES) is a predictor of mortality, and its treatment is challenging. Moreover, not all potential therapeutic strategies are available in all hospitals, and a standardized approach among European centres is lacking. The aim of this European Heart Rhythm Association (EHRA) survey was to assess the current management of patients with ES both in the acute and post-acute phases in 102 different European centres. A 20-item online questionnaire was sent out to the EHRA Research Network Centres. The median number of patients with ES treated annually per centre is 10 (IQR 5-15). The possibility of using autonomic modulation (e.g. percutaneous stellate ganglion block or thoracic epidural anaesthesia) for the acute ES treatment is available in only 29.3% of the centres. Moreover, although over 80% of centres perform ventricular tachycardia ablation, this procedure is available 24/7 in only 16.5% of the hospitals. There is a significant heterogeneity among centres regarding the availability of AADs and their use before deciding to proceed with a non-AAD strategy; specifically, 4.4% of centres use only one drug, 33.3% use two drugs, and 12.2% >two drugs, while about 50% of the centres decide based on individual patient's characteristics. Regarding the type of AADs used for the acute and post-acute management of ES patients, important variability is reported depending upon the underlying heart disease. Most patients considered for percutaneous ablation have structural heart disease. Only 46% of centres refer patients to psychological counselling after ES.

Major gaps in the information provided to patients before implantation of cardioverter defibrillators: a prospective patient European evaluation.

AIMS: Information provided to patients prior to implantable cardioverter-defibrillator (ICD) insertion and their participation in the decision-making process are crucial for understanding ICD function and accepting this lifelong therapy. The aim of this study is to evaluate the extent to which different aspects related to ICD and quality of life were transmitted to patients prior to ICD implantation. METHODS AND RESULTS: Prospective, multicenter European study with an online questionnaire initiated by the European Heart Rhythm Association. The questionnaire was filled-in directly and personally by the ICD patients who were invited to participate. A total of 1809 patients (majority in their 40s-70s, with 624 women, 34.5%) from 10 European countries participated in the study. The median time from first ICD implantation was 5 years (interquartile range 2-10). Overall, 1155 patients (71.5%) felt optimally informed at the time of device implantation, however many respondents received no information about ICD-related complications (n = 801, 49.6%), driving restrictions (n = 718, 44.5%), and possibility of end-of-life ICD deactivation (n = 408, 25.4%). Of note, women were less frequently involved in the decision-making process than men (47.3% vs. 55.9%, P = 0.003) and reported to be less often optimally informed before ICD implantation than men (61.2% vs. 76.8%, P < 0.001). More women mentioned the desire to have learned more about ICD therapy and the benefit/risk balance (45.4% vs. 33.7% of men; P < 0.001). CONCLUSIONS: This patient-based evaluation provides alarming findings on the lack of information provided to patients prior ICD implantation, particularly for women.

Prevention of venous thromboembolism in right heart-sided electrophysiological procedures: results of an European Heart Rhythm Association survey.

Limited data are available regarding venous thromboembolism (VTE), specifically deep vein thrombosis (DVT) and pulmonary embolism (PE), following right-sided ablations and electrophysiological (EP) studies. Compared to left-sided procedures, no guidelines on antithrombotic management strategies for the prevention of DVT and PE are available. The main purpose of the present European Heart Rhythm Association (EHRA) survey is to report the current management of right-sided EP procedures, focusing on anticoagulation and prevention of VTE. An online survey was conducted using the EHRA infrastructure. A total of 244 participants answered a 19-items questionnaire on the periprocedural management of EP studies and right-sided catheter ablations. The right femoral vein is the most common access for EP studies and right-sided procedures. An ultrasound-guided approach is employed by more than 2/3 of respondents. Intravenous heparin is not commonly given by the majority of participants. About 1/3 of participants (34%) routinely prescribe VTE prophylaxis during (mostly aspirin and low molecular weight heparin) and 1/4 of respondents (25%) commonly prescribe VTE prophylaxis after discharge (mostly aspirin). Of note, respectively 13% and 9% of participants observed at least one DVT and one PE related to right-sided ablation or EP study within the last year in their center. The present survey shows that only a minority of operators routinely gives intraprocedural intravenous heparin and prescribes VTE prophylaxis after right-sided EP procedures. Compared to left-sided procedures like atrial fibrillation (AF) ablation, there are no consistent systematic antithrombotic management strategies.

Outcomes after cryoballoon ablation of paroxysmal atrial fibrillation with the PolarX or the Arctic Front Advance Pro: a prospective multicentre experience.

AIMS: The aim of this study was to compare procedural efficacy and safety, including 1-year freedom from AF recurrence, between the novel cryoballoon system PolarX (Boston Scientific) and the Arctic Front Advance Pro (AFA-Pro) (Medtronic), in patients with paroxysmal AF undergoing PVI. METHODS AND RESULTS: This multicentre prospective observational study included 267 consecutive patients undergoing a first cryoablation procedure for paroxysmal AF (137 PolarX, 130 AFA-Pro). Kaplan-Meier curves with the log-rank test was used to compare the 1-year freedom from AF recurrence between both groups. Multivariate Cox model was performed to evaluate whether the type of procedure (PolarX vs. AFA-Pro) had an impact on the occurrence of AF recurrences after adjustment on potentially confounding factors. The PolarX reaches lower temperatures than the AFA-Pro (LSPV 52 ± 5, vs. 59 ± 6; LIPV 49 ± 6 vs. 56 ± 6; right superior pulmonary vein: 49 ± 6 vs. 57 ± 7; right inferior pulmonary vein: 52 ± 6 vs. 59 ± 6; P < 0.0001). A higher rate of transient phrenic nerve palsy was found in patients treated with the PolarX system (15% vs. 7%, P = 0.05). After a mean follow-up of 15 ± 5 months, 20 patients (15%) had recurrences in AFA-Pro group and 27 patients (19%) in PolarX group (P = 0.35). Based on survival analysis, no significant difference was observed between both groups with a 12-month free of recurrence survival of 91.2% (85.1-95.4%) vs. 83.7% (76.0%-89.1%) (log-rank test P = 0.11). In multivariate Cox model hazard ratio of recurrence for PolarX vs. AFA-Pro was not significant [HR = 1.6 (0.9-2.8), P = 0.12]. CONCLUSION: PolarX and AFA-Pro have comparable efficacy and safety profiles for pulmonary veins isolation in paroxysmal atrial fibrillation.

Diagnostic and therapeutic pathways for the malignant left atrial appendage: European Heart Rhythm Association physician survey.

AIMS: Patients with atrial fibrillation who despite taking oral anti-coagulant therapy (OAT) suffer a stroke or systemic embolism (SSE) without vascular cause or who develop left atrial appendage (LAA) thrombus (LAAT) should be considered as having malignant LAA. The optimal treatment strategy to reduce SSE risk in such patients is unknown. The aim of the study is to investigate the diagnostic and therapeutic pathways for malignant LAA practiced in European cardiac centres. METHODS AND RESULTS: An 18-item online questionnaire on malignant LAA was disseminated by the European Heart Rhythm Association (EHRA) Scientific Initiatives Committee. A total of 196 physicians participated in the survey. There seems to be high confidence in transoesophageal echocardiography (TEE) imaging, considering LAAT diagnosis. Switching to another direct oral anti-coagulant (DOAC) is the preferred initial step for the treatment of malignant LAA followed by a switch to vitamin K antagonist (VKA), low-molecular-weight heparin, or continued/optimized DOAC dosage, whereas LAA closure is the last option. Left atrial appendage closure is a viable option in patients with embolic stroke despite OAT and no evidence of thrombus at TEE (empty LAA) after comprehensive diagnostic measures to exclude other sources of embolism. CONCLUSION: This EHRA survey provides a snapshot of the contemporary management of patients diagnosed with malignant LAA. Currently, the majority of patients are treated on an outpatient basis with either shifting from VKA to DOAC or from one DOAC to another. Left atrial appendage closure in this population seems to be reserved for patients with higher bleeding risk or complications of malignant LAA, such as stroke.

Regional disparity on patient characteristics and perceptions after implantable cardioverter-defibrillator implantation: results from an EHRA patient survey.

AIMS: The aim of this study was to identify potential regional disparities in characteristics of implantable cardioverter-defibrillator (ICD) recipients, patient perceptions and perspectives after implantation and level of information provided to patients. METHODS AND RESULTS: The prospective, multicentre, and multinational European Heart Rhythm Association patient Survey 'Living with an ICD' included patients already implanted with an ICD (median ICD dwell time - 5 years, interquartile range 2-10). An online questionnaire was filled-in by patients invited from 10 European countries. A total of 1809 patients (the majority in their 40s to 70s, 65.5% men) were enrolled, with 877 (48.5%) from Western Europe (group 1), followed by 563 from Central/Eastern Europe (group 2, 31.1%), and 369 from Southern Europe (group 3, 20.4%). A total of 52.9% of Central/Eastern Europe patients reported increased satisfaction after ICD placement compared with 46.6% from Western and 33.1% from Southern Europe (1 vs. 2 P = 0.047, 1 vs. 3 P < 0.001, 2 vs. 3 P < 0.001). About 79.2% of Central/Eastern and 76.0% of Southern Europe patients felt optimally informed at the time of device implantation compared with just 64.6% from Western Europe (1 vs. 2 P < 0.001, 1 vs. 3 P < 0.001, 2 vs. 3 P = ns). CONCLUSIONS: While physicians in Southern Europe should address the patients' concerns about the impact of the ICD on quality of life, physicians from Western Europe should focus on improving the quality of information provided to their prospective ICD patients. Novel strategies to address regional differences in patients' quality of life and provision of information are warranted.

Pulmonary vein isolation with the radiofrequency balloon catheter: a single centre prospective study.

AIMS: The multielectrode radiofrequency balloon catheter (RFB) has been developed to achieve safe and effective pulmonary vein isolation (PVI) for atrial fibrillation (AF) ablation. This single-centre study aimed to evaluate the midterm clinical outcome and predictors of single-shot PVI with the novel RFB. METHODS AND RESULTS: All consecutive patients with symptomatic paroxysmal or persistent AF undergoing first-time PVI with the RFB were prospectively included. Clinical and procedural parameters were systematically collected. The primary safety endpoint was defined as any major periprocedural complications. The primary efficacy endpoint consisted of freedom from any atrial tachyarrhythmias (ATas) lasting >30 s during the follow-up after a 3-month blanking period. Persistent single-shot PVI was defined as PVI achieved with a single RFB application without acute reconnection. A total of 104 consecutive patients (mean age 64.3 ± 11.4 years, 56.7% males) were included. 15 patients (14.4%) presented with persistent AF. The procedure time was 59.0 min with a dwell time of 20.0 min. One major complication occurred in one patient. At a mean follow-up of 10.1 ± 5.3 months, freedom from ATas was 82.9%. ATas occurred in 14 patients, 11/69 patients (15.9%) with paroxysmal AF and 3/13 (23.1%) with persistent AF. The best cut-offs to predict persistent single-shot PVI were impedance drop >19.2 Ω [area under the receiver operator characteristic curve (AUC) 0.74] and temperature rise >11.1° C (AUC 0.77). CONCLUSION: In a large cohort of patients undergoing PVI with the RFB, the complication rate was 1%. At a mid-term follow-up of 10.1 ± 5.3 months, freedom from ATas was 82.9%. Specific cut-offs of impedance drop and temperature rise may be useful to predict persistent single-shot isolation.

Hybrid atrial fibrillation ablation: long-term outcomes from a single-centre 10-year experience.

AIMS: Hybrid atrial fibrillation (AF) ablation is a promising approach in non-paroxysmal AF. The aim of this study is to assess the long-term outcomes of hybrid ablation in a large cohort of patients after both an initial and as a redo procedure. METHODS AND RESULTS: All consecutive patients undergoing hybrid AF ablation at UZ Brussel from 2010 to 2020 were retrospectively evaluated. Hybrid AF ablation was performed in a one-step procedure: (i) thoracoscopic ablation followed by (ii) endocardial mapping and eventual ablation. All patients received PVI and posterior wall isolation. Additional lesions were performed based on clinical indication and physician judgement. Primary endpoint was freedom from atrial tachyarrhythmias (ATas). A total of 120 consecutive patients were included, 85 patients (70.8%) underwent hybrid AF ablation as first procedure (non-paroxysmal AF 100%), 20 patients (16.7%) as second procedure (non-paroxysmal AF 30%), and 15 patients (12.5%) as third procedure (non-paroxysmal AF 33.3%). After a mean follow-up of 62.3 months ± 20.3, a total of 63 patients (52.5%) experienced ATas recurrence. Complications occurred in 12.5% of patients. There was no difference in ATas between patients undergoing hybrid as first vs. redo procedure (P = 0.53). Left atrial volume index and recurrence during blanking period were independent predictors of ATas recurrence. CONCLUSION: In a large cohort of patients undergoing hybrid AF ablation, the survival from ATas recurrence was 47.5% at ≈5 years follow-up. There was no difference in clinical outcomes between patients undergoing hybrid AF ablation as first procedure or as a redo.

Treatment of pathophysiologic propagation outside of the pulmonary veins in retreatment of atrial fibrillation patients: RECOVER AF study.

AIMS: RECOVER AF evaluated the performance of whole-chamber non-contact charge-density mapping to guide the ablation of non-pulmonary vein (PV) targets in persistent atrial fibrillation (AF) patients following either a first or second failed procedure. METHODS AND RESULTS: RECOVER AF was a prospective, non-randomized trial that enrolled patients scheduled for a first or second ablation retreatment for recurrent AF. The PVs were assessed and re-isolated if necessary. The AF maps were used to guide the ablation of non-PV targets through elimination of pathologic conduction patterns (PCPs). Primary endpoint was freedom from AF on or off antiarrhythmic drugs (AADs) at 12 months. Patients undergoing retreatment with the AcQMap System (n = 103) were 76% AF-free at 12 months [67% after single procedure (SP)] on or off AADs (80% free from AF on AADs). Patients who had only received a pulmonary vein isolation (PVI) prior to study treatment of non-PV targets with the AcQMap System were 91% AF-free at 12 months (83% SP). No major adverse events were reported. CONCLUSION: Non-contact mapping can be used to target and guide the ablation of PCPs beyond the PVs in persistent AF patients returning for a first or second retreatment with 76% freedom from AF at 12 months. The AF freedom was particularly high, 91% (43/47), for patients enrolled having only a prior de novo PVI, and freedom from all atrial arrhythmias for this cohort was 74% (35/47). These early results are encouraging and suggest that guiding individualized targeted ablation of PCPs may therefore be advantageous to target at the earliest opportunity in patients with persistent AF.

Coronary artery disease in atrial fibrillation ablation: impact on arrhythmic outcomes.

AIMS: Catheter ablation (CA) is an established treatment for atrial fibrillation (AF). A computed tomography (CT) may be performed before ablation to evaluate the anatomy of pulmonary veins. The aim of this study is to investigate the prevalence of patients with coronary artery disease (CAD) detected by cardiac CT scan pre-ablation and to evaluate the impact of CAD and revascularization on outcomes after AF ablation. METHODS AND RESULTS: All consecutive patients with AF diagnosis, hospitalized at Universitair Ziekenhuis Brussel, Belgium, between 2015 and 2019, were prospectively screened for enrolment in the study. Inclusion criteria were (i) AF diagnosis, (ii) first procedure of AF ablation with cryoballoon CA, and (iii) contrast CT scan performed pre-ablation. A total of 576 consecutive patients were prospectively included and analysed in this study. At CT scan, 122 patients (21.2%) were diagnosed with CAD, of whom 41 patients (7.1%) with critical CAD. At survival analysis, critical CAD at CT scan was a predictor of atrial tachyarrhythmia (AT) recurrence during the follow-up, only in Cox univariate analysis [hazard ratio (HR) = 1.79] but was not an independent predictor in Cox multivariate analysis. At Cox multivariate analysis, independent predictors of AT recurrence were as follows: persistent AF (HR = 2.93) and left atrium volume index (HR = 1.04). CONCLUSION: In patients undergoing CT scan before AF ablation, critical CAD was diagnosed in 7.1% of patients. Coronary artery disease and revascularization were not independent predictors of recurrence; thus, in this patient population, AF ablation should not be denied and can be performed together with CAD treatment.

Outcomes of pulmonary vein isolation with radiofrequency balloon vs. cryoballoon ablation: a multi-centric study.

AIMS: Cryoballoon (CB) ablation is the mainstay of single-shot pulmonary vein isolation (PVI). A radiofrequency balloon (RFB) catheter has recently emerged as an alternative. However, these two technologies have not been compared. This study aims to evaluate the freedom from atrial tachyarrhythmias (ATas) at 1 year: procedural characteristics, efficacy, and safety of the novel RFB compared with CB for PVI in patients with paroxysmal atrial fibrillation (AF). METHODS AND RESULTS: This prospective multi-centre study included consecutive patients with symptomatic drug-resistant paroxysmal AF who underwent PVI with RFB or CB between July 2021 and January 2022 from three European centres. A total of 375 consecutive patients were included, 125 in the RFB group and 250 in the CB. Both groups had comparable clinical characteristics. At 12.33 ± 4.91 months, ATas-free rates were 83.20% and 82.00% in the RFB and CB groups, respectively (P > 0.05). Compared with the CB group, the RFB group showed a shorter procedure time [59.91 (45.80-77.12) vs. 77.0 (35.13-122.71) min (P < 0.001)], dwell time [19.59 (14.41-30.24) vs. 27.03 (17.11-57.21) min (P = 0.04)], time to isolation, and thermal energy delivery in all pulmonary veins (P < 0.001). First-pass isolation was comparable. No major complications occurred in either group, with no stroke, atrio-oesophageal fistula, or permanent phrenic nerve injury. Transient phrenic nerve palsy occurred more frequently with CB than RFB (7.20% vs. 3.20%; P = 0.02). Oesophageal temperature rise occurred in 21 (16.8%) patients in the RFB group, and gastroscopy showed erythema in two of them with complete recovery after 30 days. CONCLUSIONS: The RFB appears to have a safety and efficacy profile similar to that of the CB for PVI. Shorter procedural times appear to be driven by shorter left atrial dwell and thermal delivery times.