A danish healthcare-focused economic evaluation of first-line cryoballoon ablation versus antiarrhythmic drug therapy for the treatment of paroxysmal atrial fibrillation.

INTRODUCTION: Three randomised controlled trials (RCTs) have demonstrated that first-line cryoballoon pulmonary vein isolation decreases atrial tachycardia in patients with symptomatic paroxysmal atrial fibrillation (PAF) compared with antiarrhythmic drugs (AADs). The aim of this study was to develop a cost-effectiveness model (CEM) for first-line cryoablation compared with first-line AADs for the treatment of PAF. The model used a Danish healthcare perspective. METHODS: Individual patient-level data from the Cryo-FIRST, STOP AF and EARLY-AF RCTs were used to parameterise the CEM. The model structure consisted of a hybrid decision tree (one-year time horizon) and a Markov model (40-year time horizon, with a three-month cycle length). Health-related quality of life was expressed in quality-adjusted life years (QALYs). Costs and benefits were discounted at 3% per year. Model outcomes were produced using probabilistic sensitivity analysis. RESULTS: First-line cryoablation is dominant, meaning it results in lower costs (-€2,663) and more QALYs (0.18) when compared to first-line AADs. First-line cryoablation also has a 99.96% probability of being cost-effective, at a cost-effectiveness threshold of €23,200 per QALY gained. Regardless of initial treatment, patients were expected to receive ∼ 1.2 ablation procedures over a lifetime horizon. CONCLUSION: First-line cryoablation is both more effective and less costly (i.e. dominant), when compared with AADs for patients with symptomatic PAF in a Danish healthcare system.

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.

"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.

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.

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.

Redo procedures after sinus node sparing hybrid ablation for inappropriate sinus tachycardia/postural orthostatic sinus tachycardia.

AIMS: A novel sinus node (SN) sparing hybrid ablation for inappropriate sinus node tachycardia (IST)/postural orthostatic tachycardia syndrome (POTS) has been demonstrated to be an effective and safe therapeutic option in patients with symptomatic drug-resistant IST/POTS. The aim of this study was to evaluate the long-term rate of redo procedures after hybrid IST ablation and procedural strategy, outcomes and safety of redo procedures. METHODS AND RESULTS: All consecutive patients from 2015 to 2023 were prospectively enrolled in the UZ Brussel monocentric IST/POTS registry. They were analysed if the following inclusion criteria were fulfilled: 1) diagnosis of IST or POTS, 2) symptomatic IST/POTS refractory or intolerant to drugs, and 3) hybrid SN sparing ablation performed. The primary endpoint was redo procedure. The primary safety endpoint was pacemaker (PM) implantation. A total of 220 patients undergone to hybrid IST ablation were included, 185 patients (84.1%) were treated for IST and 61 patients (27.7%) for POTS.After a follow-up of 73.3 ± 16.2 months, 34 patients (15.4%) underwent a redo. A total of 23 patients (67.6%) had a redo for IST recurrence and 11 patients (32.4%) for other arrhythmias. Pacemaker implantation was performed in 21 patients (9.5%). Nine patients (4.1%) had no redo procedure and experienced sick sinus syndrome requiring a PM. Twelve patients (5.4%) received a PM as a shared therapeutic choice combined with SN ablation procedure. CONCLUSION: In a large cohort of patients the long-term free survival from redo procedure after hybrid IST ablation was 84.6% with a low PM implantation rate.

Genetic testing in children with Brugada syndrome: results from a large prospective registry.

AIMS: A pathogenic/likely pathogenic (P/LP) variant in SCN5A is found in 20-25% of patients with Brugada syndrome (BrS). However, the diagnostic yield and prognosis of gene panel testing in paediatric BrS is unclear. The aim of this study is to define the diagnostic yield and outcomes of SCN5A gene testing with ACMG variant classification in paediatric BrS patients compared with adults. METHODS AND RESULTS: All consecutive patients diagnosed with BrS, between 1992 and 2022, were prospectively enrolled in the UZ Brussel BrS registry. Inclusion criteria were: (i) BrS diagnosis; (ii) genetic analysis performed with a large gene panel; and (iii) classification of gene variants following ACMG guidelines. Paediatric patients were defined as ≤16 years of age. The primary endpoint was ventricular arrhythmias (VAs). A total of 500 BrS patients were included, with 63 paediatric patients and 437 adult patients. Among children with BrS, 29 patients (46%) had a P/LP variant (P+) in SCN5A and no variants were found in 34 (54%) patients (P-). After a mean follow-up of 125.9 months, 8 children (12.7%) experienced a VA, treated with implanted cardioverter defibrillator shock. At survival analysis, P- paediatric patients had higher VA-free survival during the follow-up, compared with P+ paediatric patients. P+ status was an independent predictor of VA. There was no difference in VA-free survival between paediatric and adult BrS patients for both P- and P+. CONCLUSION: In a large BrS cohort, the diagnostic yield for P/LP variants in the paediatric population is 46%. P+ children with BrS have a worse arrhythmic prognosis.

Prognostic value of chronic kidney disease in patients undergoing left atrial appendage occlusion.

AIMS: Atrial fibrillation (AF) and chronic kidney disease (CKD) often coexist and share an increased risk of thrombo-embolism (TE). CKD concomitantly predisposes towards a pro-haemorrhagic state. Our aim was to evaluate the prognostic value of CKD in patients undergoing percutaneous left atrial appendage occlusion (LAAO). METHODS AND RESULTS: A total of 2124 consecutive AF patients undergoing LAAO were categorized into CKD stage 1+2 (n = 1089), CKD stage 3 (n = 796), CKD stage 4 (n = 170), and CKD stage 5 (n = 69) based on the estimated glomerular filtration rate at baseline. The primary endpoint included cardiovascular (CV) mortality, TE, and major bleeding. The expected annual TE and major bleeding risks were estimated based on the CHA2DS2-VASc and HAS-BLED scores. A non-significant higher incidence of major peri-procedural adverse events (1.7 vs. 2.3 vs. 4.1 vs. 4.3) was observed with worsening CKD (P = 0.14). The mean follow-up period was 13 ± 7 months (2226 patient-years). In comparison to CKD stage 1+2 as a reference, the incidence of the primary endpoint was significantly higher in CKD stage 3 (log-rank P-value = 0.04), CKD stage 4 (log-rank P-value = 0.01), and CKD stage 5 (log-rank P-value = 0.001). Left atrial appendage occlusion led to a TE risk reduction (RR) of 72, 66, 62, and 41% in each group. The relative RR of major bleeding was 58, 44, 51, and 52%, respectively. CONCLUSION: Patients with moderate-to-severe CKD had a higher incidence of the primary composite endpoint. The relative RR in the incidence of TE and major bleeding was consistent across CKD groups.

Three-dimensional intracardiac echocardiography for left atrial appendage sizing and percutaneous occlusion guidance.

AIMS: Left atrial appendage (LAA) imaging is critical during percutaneous occlusion procedures. 3D-intracardiac echocardiography (ICE) features direct visualization of LAA from multiple cross-sectional planes at a time. We aimed at reporting procedural success of 3D-ICE-guided LAA occlusion and the correlation between pre-procedural transoesophageal echocardiography (TEE) and intraprocedural 3D-ICE for LAA sizing. METHODS AND RESULTS: Among 274 patients undergoing left atrial appendage occlusion (LAAO) with a Watchman FLX, periprocedural ICE guidance was achieved via a commercially available 2D-ICE catheter (220 patients) or a novel (NUVISION™) 3D-ICE one (54 patients). Primary endpoint was a composite of procedural success and LAA sealing at follow-up TEE. Secondary endpoint was a composite of periprocedural device recapture/resizing plus presence of leaks ≥ 3 mm at follow-up TEE. 3D-ICE measurements of maximum landing zone correlated highly with pre-procedural TEE reference values [Pearson's: 0.94; P < 0.001; bias: -0.06 (-2.39, 2.27)]. The agreement between 3D-ICE-based device selection and final device size was 96.3% vs. 79.1% with 2D-ICE (P = 0.005). The incidence of the primary endpoint was 98.1% with 3D-ICE and 97.3% with 2D-ICE (P = 0.99). 2D-ICE patients had a trend towards a higher incidence of periprocedural device recapture/redeployment (31.5% vs. 44.5%; P = 0.09). The secondary endpoint occurred in 31.5% of 3D-ICE patients vs. 45.9% of 2D-ICE ones (P = 0.065). CONCLUSION: Intracardiac echocardiography-guided LAAO showed a very high success, with no major adverse events. A very high level of agreement for LAA sizing was found between pre-procedural TEE and periprocedural 3D-ICE. 3D-ICE performed significantly better than 2D-ICE for FLX size selection and may provide better guidance during device deployment.

Pulsed electric field, cryoballoon, and radiofrequency for paroxysmal atrial fibrillation ablation: a propensity score-matched comparison.

AIMS: Pulsed field ablation (PFA) has emerged as a novel, non-thermal energy source to selectively ablate cardiac tissue. We describe a multicentre experience on pulmonary vein isolation (PVI) via the pentaspline Farapulse™ PFA system vs. thermal-based technologies in a propensity score-matched population of paroxysmal atrial fibrillation (PAF) patients. METHODS AND RESULTS: Propensity score matching was adopted to compare PVI-only ablation outcomes via the Farawave™ system (Group PFA), cryoballoon (Group CRYO), or focal radiofrequency (Group RF) (PFA:CRYO:RF ratio = 1:2:2). Among 1572 (mean age: 62.4 ± 11.3 years; 42.5% females) PAF patients undergoing first time PVI with either PFA (n = 174), CRYO (n = 655), or RF (n = 743), propensity score matching yielded 174 PFA, 348 CRYO, and 348 RF patients. First-pass isolation was achieved in 98.8% of pulmonary veins (PVs) with PFA, 81.5% with CRYO, and 73.1% with RF (P < 0.001). Procedural and dwell times were significantly shorter with PFA, whereas the availability of a 3D mapping system led to a significant reduction in X-ray exposure with RF. Overall complication rates were 3.4% (n = 6) with PFA, 8.6% (n = 30) with CRYO, and 5.5% (n = 19) with RF (P = 0.052). The 1-year Kaplan-Meier estimated freedom from any atrial tachyarrhythmia was 79.3% with PFA, 74.7% with CRYO, and 72.4% with RF (log-rank P-value: 0.24). Among 145 repeat ablation procedures, PV reconnection rate was 19.1% after PFA, 27.5% after CRYO, and 34.8% after RF (P = 0.01). CONCLUSION: Pulsed field ablation contributed to significantly shorter procedural times. Follow-up data showed a similar arrhythmia freedom, although a higher rate of PV reconnection was documented in post-CRYO and post-RF redo procedures.

High power short duration versus low power long duration ablation in patients with atrial fibrillation: A meta-analysis of randomized trials.

BACKGROUND: High-power-short-duration (HPSD) radiofrequency (RF) ablation is a viable alternative to low-power-long-duration (LPLD) RF for pulmonary vein isolation (PVI). Nevertheless, trials showed conflicting results regarding atrial fibrillation (AF) recurrences and few data concerning complications. Therefore, we conducted a meta-analysis of randomized trials comparing HPSD versus LPLD. METHODS: We systematically searched the electronic databases for studies published from inception to March 31, 2023 focusing on HPSD versus LPLD. The study endpoints were AF recurrence, procedural times and overall complications. RESULTS: Five studies enrolling 424 patients met the inclusion criteria (mean age 61.1 years; 54.3% paroxysmal AF; mean LVEF 58.2%). Compared to LPLD, HPSD showed a significantly lower AF recurrence rate [16.3% vs. 30,1%; RR: 0.54 (95% CI: 0.38-0.79); p = 0.001] at a mean 10.9 months follow-up. Moreover, HPSD led to a significant reduction in total procedural time [MD: -26.25 min (95%CI: -42.89 to -9.61); p = 0.002], PVI time [MD: -26.44 min (95%CI: -38.32 to -14.55); p < 0.0001], RF application time [MD: -8.69 min (95%CI: -11.37 to -6.01); p < 0.00001] and RF lesion number [MD: -7.60 (95%CI: -10.15 to -5.05); p < 0.00001]. No difference was found in either right [80.4% vs. 78.2%; RR: 1.04 (95% CI: 0.81-1.32); p = 0.77] or left [92.3% vs. 90.2%; RR: 1.02 (95% CI: 0.94-1.11); p = 0.58] first-pass isolation and overall complications [6% vs. 3.7%; RR: 1.45 (95%CI: 0.53-3.99); p = 0.47] between groups. CONCLUSION: In our metanalysis of randomized trials, HPSD ablation appeared to be associated to a significantly improved freedom from AF and shorter procedures, without increasing the risk of complications.

Axillary vein puncture versus cephalic vein cutdown for cardiac implantable electronic device implantation: A meta-analysis.

INTRODUCTION: Cephalic vein cutdown (CVC) and axillary vein puncture (AVP) are both recommended for transvenous implantation of leads for cardiac implantable electronic devices (CIEDs). Nonetheless, it is still debated which of the two techniques has a better safety and efficacy profile. METHODS: We systematically searched Medline, Embase, and Cochrane electronic databases up to September 5, 2022, for studies that evaluated the efficacy and safety of AVP and CVC reporting at least one clinical outcome of interest. The primary endpoints were acute procedural success and overall complications. The effect size was estimated using a random-effect model as risk ratio (RR) and relative 95% confidence interval (CI). RESULTS: Overall, seven studies were included, which enrolled 1771 and 3067 transvenous leads (65.6% [n = 1162] males, average age 73.4 ± 14.3 years). Compared to CVC, AVP showed a significant increase in the primary endpoint (95.7 % vs. 76.1 %; RR: 1.24; 95% CI: 1.09-1.40; p = .001) (Figure 1). Total procedural time (mean difference [MD]: -8.25 min; 95% CI: -10.23 to -6.27; p < .0001; I2  = 0%) and venous access time (MD: -6.24 min; 95% CI: -7.01 to -5.47; p < .0001; I2  = 0%) were significantly shorter with AVP compared to CVC. No differences were found between AVP and CVC for incidence overall complications (RR: 0.56; 95% CI: 0.28-1.10; p = .09), pneumothorax (RR: 0.72; 95% CI: 0.13-4.0; p = .71), lead failure (RR: 0.58; 95% CI: 0.23-1.48; p = .26), pocket hematoma/bleeding (RR: 0.58; 95% CI: 0.15-2.23; p = .43), device infection (RR: 0.95; 95% CI: 0.14-6.60; p = .96) and fluoroscopy time (MD: -0.24 min; 95% CI: -0.75 to 0.28; p = .36). CONCLUSION: Our meta-analysis suggests that AVP may improve procedural success and reduce total procedural time and venous access time compared to CVC.

Heart rate variability and microvolt T wave alternans changes during ajmaline test may predict prognosis in Brugada syndrome.

PURPOSE: Drug-induced type I Brugada syndrome (BrS) is associated with a ventricular arrhythmia (VA) rate of 1 case per 100 person-years. This study aims to evaluate changes in electrocardiographic (ECG) parameters such as microvolt T wave alternans (mTWA) and heart rate variability (HRV) at baseline and during ajmaline testing for BrS diagnosis. METHODS: Consecutive patients diagnosed with BrS during ajmaline testing with 5-year follow-up were included in this study. For comparison, a negative ajmaline control group and an isoproterenol control group were also included. ECG recordings during ajmaline or isoproterenol test were divided in two timeframes from which ECG parameters were calculated: a 5-min baseline timeframe and a 5-min drug timeframe. RESULTS: A total of 308 patients with BrS were included, 22 (0.7%) of which suffered VAs during follow-up. One hundred patients were included in both isoproterenol and negative ajmaline control groups. At baseline, there was no difference in ECG parameters between control groups and patients with BrS, nor between BrS with and without VAs. During ajmaline testing, BrS with VAs presented longer QRS duration [159 ± 34 ms versus 138 (122-155) ms, p = 0.006], higher maximum mTWA [33.8 (14.0-114) µV versus 8.00 (3.67-28.2) µV, p = 0.001], and lower power in low frequency band [25.6 (5.8-53.8) ms2 versus 129.5 (52.7-286) ms2, p < 0.0001] when compared to BrS without VAs. CONCLUSIONS: Ajmaline induced important HRV changes similar to those observed during isoproterenol. Increased mTWA was observed only in patients with BrS. BrS with VAs during follow-up presented worse changes during ajmaline test, including lower LF power and higher maximum mTWA which were independent predictors of events.

Evaluation of coronary artery disease in patients undergoing atrial fibrillation ablation: a non-invasive FFR computed tomography study.

To evaluate coronary artery disease (CAD) with computed tomography coronary angiography (CTCA)-derived fractional flow reserve (FFR) in patients with atrial fibrillation (AF) requiring ablation. The study population consisted of 151 patients who underwent CTCA before AF ablation (AF group), and a control group of 151 patients from the outpatient clinic who underwent CTCA without any history of AF (non-AF group), matched for age, sex, BMI, and angina symptomatology. All study patients underwent CTCA with subdivision of coronary lesion type into severe (≥ 70% luminal narrowing), moderate (50% ≤ luminal narrowing < 70%), and mild stenosis (< 50% luminal narrowing). In patients with ≥ 1 moderate or severe stenosis, non-invasive FFR was calculated from CTCA (FFRCT). Baseline characteristics and CAD risk factors were similar between the 2 groups. During CTCA, 38% of the patients in the AF group were in ongoing atrial arrhythmia (either AF or regular atrial tachycardia). The number of patients with severe (10 (6.6%) vs 10 (6.6%), P = 1.00), moderate (14 (9.5%) vs 10 (6.7%), P = 0.4), and mild stenosis (43 (28.5%) vs 56 (37.1%), P = 0.11) was not significantly different between the 2 groups. Performance of FFRCT was feasible in 32/44 patients (73%), and failed in 27% of the patients (7 and 5 patients in the AF and non-AF group, respectively, P = 0.74). No difference was observed in the prevalence of hemodynamically significant stenosis (FFRCT ≤ 0.80) (15 (9.9%) vs 12 (7.9%), P = 0.85). Our study showed technical feasibility of CTCA in all patients of both groups, including the patients with AF as presenting rhythm. The FFRCT add-on analysis failed equally frequent in patients of the AF versus non-AF group. An equal rate of CAD was observed in the AF group and non-AF group, favoring the concept of shared associated risk factors for CAD and AF.

Feasibility and safety of reprocessing of intracardiac echocardiography catheters for electrophysiology procedures - a large single center experience.

PURPOSE: Intra-cardiac echocardiography (ICE) has become an important tool for catheter ablation. Adoption of ICE imaging is still limited because of its prohibitively high cost. Our aim was to study the safety and feasibility of ICE catheters reprocessing and its environmental and financial impact. METHODS: This was a single center retrospective analysis of all consecutive electrophysiology procedures in which ICE catheters were used from 2015 to 2022. In total, 1128 patients were studied (70.6% male, mean age was 57.9 ± 13.2 years). The majority of procedures were related to atrial fibrillation ablation (84.6%). RESULTS: For the whole cohort, 57 new ICE catheters were used. Consequently one catheter could be used for 19.8 procedures. New catheters were only used when the image obtained by reused probes was not satisfactory. There were no cases of ICE probe steering mechanism malfunction, no procedure related infections and no allergic reactions that could be attributed to the resterilization process. In total, there was 8.6% of complications not related to ICE imaging. Financially, ICE probe reprocessing resulted with 90% cost reduction (> 2 millions of Euros savings for the studied period) and 95% waste reduction (639.5 kg less, mostly non degradable waste was produced). CONCLUSION: Our data suggests that ICE catheter reprocessing is feasible and safe. It seems that risk of infection is not increased. Significant economic and environmental savings could be achieved by ICE catheters reprocessing. Furthermore, ICE reprocessing could allow more extensive ICE usage resulting in safer procedures with a potential reduction of serious complications.

Effectiveness and safety of a time to isolation strategy of cryoballoon ablation of atrial fibrillation: A systematic review and meta-analysis.

AIM: We conducted a systematic review and meta-analysis of randomized and observational studies with a control group to evaluate the effectiveness and safety of a time to isolation (TTI)-based strategy of cryoballoon ablation (CBA) in the treatment of atrial fibrillation (AF). METHODS: Three electronic databases (MEDLINE, Cochrane Central Register of Controlled Trials, and Embase) without language restrictions were searched. The intervention assessed was a TTI-based strategy of CBA in the treatment of AF. TTI was defined as the time from the start of freezing to the last recorded pulmonary veins' potential. The comparison of interest was intended conventional protocol of CBA. The primary endpoint was freedom from atrial arrhythmia. RESULTS: Nine studies were deemed eligible (N = 2289 patients). Eight studies reported freedom from atrial arrhythmia and pooled results showed a marginally similar success rate between the two protocols (odds ratio [OR]: 1.24; 95% confidence interval [CI]: 0.98-1.56). A prespecified subgroup analysis verified that a high dose TTI strategy (with >120 s duration of cryotherapy post-TTI) compared to the conventional protocol could significantly increase the patients without atrial arrhythmia during follow-up (OR: 1.39; 95% CI: 1.05-1.83). TTI strategy could also significantly decrease total procedure time (SMD: -26.24 min; 95% CI: -36.90 to -15.57) and phrenic nerve palsy incidence (OR: 0.49; 95% CI: 0.29-0.84). CONCLUSION: Moderate confidence evidence suggests that an individualized CBA dosing strategy based on TTI and extended (>2 min post-TTI) duration of CBA is accompanied by fewer recurrences post-AF ablation.

New evidence: Cryoballoon ablation vs. antiarrhythmic drugs for first-line therapy of atrial fibrillation.

Atrial fibrillation (AF) is a commonly encountered chronic and progressive heart rhythm disorder, characterized by exacerbations and remissions. Contemporary clinical practice guidelines recommend a trial of antiarrhythmic drugs (AADs) as the initial therapy for sinus rhythm maintenance; however, these medications have modest efficacy and are associated with significant adverse effects. Recently, several trials have demonstrated that an initial treatment strategy of cryoballoon catheter ablation significantly improves arrhythmia outcomes (e.g. freedom atrial tachyarrhythmia and reduction in arrhythmia burden), produces clinically meaningful improvements in patient-reported outcomes (e.g. symptoms and quality of life), and significantly reduces subsequent healthcare resource utilization (e.g. hospitalization), without increasing the risk of serious or any adverse events. These findings are relevant to patients, providers, and healthcare systems, helping inform the decision regarding the initial choice of rhythm-control therapy in patients with treatment-naïve AF.