Feasibility of double-blinded, placebo-controlled interventional study for assessing catheter ablation efficacy in persistent atrial fibrillation: Insights from the ORBITA AF feasibility study.

BACKGROUND: To date, there are no randomized, double-blinded clinical trials comparing catheter ablation to DC cardioversion (DCCV) with medical therapy in patients with persistent atrial fibrillation (PersAF). Conducting a large-scale trial to address this question presents considerable challenges, including recruitment, blinding, and implementation. We conducted a pilot study to evaluate the feasibility of conducting a definitive placebo-controlled trial. METHODS: This prospective trial was carried out at Barts Heart Centre, United Kingdom, employing a randomized, double-blinded, placebo-controlled design. Twenty patients with PersAF (duration <2 years) were recruited, representing 10% of the proposed larger trial as determined by a power calculation. The patients were randomized in a 1:1 ratio to receive either PVI ± DCCV (PVI group) or DCCV + Placebo (DCCV group). The primary endpoint of this feasibility study was to evaluate patient blinding. Patients remained unaware of their treatment allocation until end of study. RESULTS: During the study, 35% of patients experienced recurrence of PersAF prior to completion of 12 months follow-up. Blinding was successfully maintained amongst both patients and medical staff. The DCCV group had a trend to higher recurrence and repeat procedure rate compared to the PVI group (recurrence of PersAF 60% vs 30%; p = .07 and repeat procedure 70% vs 40%; p = .4). The quality of life experienced by individuals in the PVI group showed improvement, as evidenced by enhanced scores on the AF specific questionnaire (AF PROMS) (3 [±4] vs 21 [±8]) and SF-12 mental-component raw score (51.4 [±7] vs 43.24 [±15]) in patients who maintained sinus rhythm at 12 months. CONCLUSION: This feasibility study establishes the potential for conducting a blinded, placebo-controlled trial to evaluate the efficacy of PVI versus DCCV in patients with PersAF.

2024 European Heart Rhythm Association/Heart Rhythm Society/Asia Pacific Heart Rhythm Society/Latin American Heart Rhythm Society expert consensus statement on catheter and surgical ablation of atrial fibrillation.

In the last three decades, ablation of atrial fibrillation (AF) has become an evidence-based safe and efficacious treatment for managing the most common cardiac arrhythmia. In 2007, the first joint expert consensus document was issued, guiding healthcare professionals involved in catheter or surgical AF ablation. Mounting research evidence and technological advances have resulted in a rapidly changing landscape in the field of catheter and surgical AF ablation, thus stressing the need for regularly updated versions of this partnership which were issued in 2012 and 2017. Seven years after the last consensus, an updated document was considered necessary to define a contemporary framework for selection and management of patients considered for or undergoing catheter or surgical AF ablation. This consensus is a joint effort from collaborating cardiac electrophysiology societies, namely the European Heart Rhythm Association, the Heart Rhythm Society, the Asia Pacific Heart Rhythm Society, and the Latin American Heart Rhythm Society .

Catheter ablation of atrial fibrillation with a multi-electrode radiofrequency balloon; first and early two centre experience in Europe.

INTRODUCTION: The Heliostar™ ablation system is a novel RF balloon ablation technology with an integrated three-dimensional mapping system. Here, we describe our early experience and procedural outcomes using this technology for atrial fibrillation catheter ablation. METHODS: We sought to comprehensively assess the first 60 consecutive patients undergoing pulmonary vein isolation using the novel HELISOTAR™ RF balloon technology including procedural outcomes. A comparison of the workflow between two different anaesthetic modalities (conscious sedation [CS] vs. general anaesthesia [GA]) was made. Procedural data were collected prospectively from two high-volume centers (Barts Heart Centre, UK and University Hospital of Zurich, Zurich). A standardized approach for catheter ablation was employed. RESULTS: A total of 35 patients had the procedure under CS and the remaining under GA. Mean procedural and fluoroscopy times were 84 ± 33 min and 1.1 min. The median duration of RF energy application was 7 (5-9.8) mins per patient. All veins were successfully isolated, and the median isolation time was 10 (7-15) seconds. Our cohort's rate of procedural complications was low, with no mortality within 30 days postprocedure. CONCLUSION: Our early experience shows that catheter ablation using the Heliostar™ technology can be performed efficiently and safely; however, long-term data is yet to be established. Low fluoroscopy requirements, short learning curves and use of this technology with CS is possible, including the use of an oesophageal temperature probe.

Atrial fibrillation cryoablation is an effective day case treatment: the UK PolarX vs. Arctic Front Advance experience.

AIMS: Pulmonary vein isolation (PVI) is the cornerstone of catheter ablation for atrial fibrillation (AF). There are limited data on the PolarX Cryoballoon. The study aimed to establish the safety, efficacy, and feasibility of same day discharge for Cryoballoon PVI. METHODS AND RESULTS: Multi-centre study across 12 centres. Procedural metrics, safety profile, and procedural efficacy of the PolarX Cryoballoon with the Arctic Front Advance (AFA) Cryoballoon were compared in a cohort large enough to provide definitive comparative data. A total of 1688 patients underwent PVI with cryoablation (50% PolarX and 50% AFA). Successful PVI was achieved with 1677 (99.3%) patients with 97.2% (n = 1641) performed as day case procedures with a complication rate of <1%. Safety, procedural metrics, and efficacy of the PolarX Cryoballoon were comparable with the AFA cohort. The PolarX Cryoballoon demonstrated a nadir temperature of -54.6 ± 7.6°C, temperature at 30 s of -38.6 ± 7.2°C, time to -40°C of 34.1 ± 13.7 s, and time to isolation of 49.8 ± 33.2 s. Independent predictors for achieving PVI included time to reach -40°C [odds ratio (OR) 1.34; P < 0.001] and nadir temperature (OR 1.24; P < 0.001) with an optimal cut-off of ≤34 s [area under the curve (AUC) 0.73; P < 0.001] and nadir temperature of ≤-54.0°C (AUC 0.71; P < 0.001), respectively. CONCLUSIONS: This large-scale UK multi-centre study has shown that Cryoballoon PVI is a safe, effective day case procedure. PVI using the PolarX Cryoballoon was similarly safe and effective as the AFA Cryoballoon. The cryoablation metrics achieved with the PolarX Cryoballoon were different to that reported with the AFA Cryoballoon. Modified cryoablation targets are required when utilizing the PolarX Cryoballoon.

Evidence to support magnetic resonance conditional labelling of all pacemaker and defibrillator leads in patients with cardiac implantable electronic devices.

AIMS: Many cardiac pacemakers and defibrillators are not approved by regulators for magnetic resonance imaging (MRI). Even following generator exchange to an approved magnetic resonance (MR)-conditional model, many systems remain classified 'non-MR conditional' due to the leads. This classification makes patient access to MRI challenging, but there is no evidence of increased clinical risk. We compared the effect of MRI on non-MR conditional and MR-conditional pacemaker and defibrillator leads. METHODS AND RESULTS: Patients undergoing clinical 1.5T MRI with pacemakers and defibrillators in three centres over 5 years were included. Magnetic resonance imaging protocols were similar for MR-conditional and non-MR conditional systems. Devices were interrogated pre- and immediately post-scan, and at follow-up, and adverse clinical events recorded. Lead parameter changes peri-scan were stratified by MR-conditional labelling. A total of 1148 MRI examinations were performed in 970 patients (54% non-MR conditional systems, 39% defibrillators, 15% pacing-dependent) with 2268 leads. There were no lead-related adverse clinical events, and no clinically significant immediate or late lead parameter changes following MRI in either MR-conditional or non-MR conditional leads. Small reductions in atrial and right ventricular sensed amplitudes and impedances were similar between groups, with no difference in the proportion of leads with parameter changes greater than pre-defined thresholds (7.1%, 95% confidence interval: 6.1-8.3). CONCLUSIONS: There was no increased risk of MRI in patients with non-MR conditional pacemaker or defibrillator leads when following recommended protocols. Standardizing MR conditions for all leads would significantly improve access to MRI by enabling patients to be scanned in non-specialist centres, with no discernible incremental risk.

Efficacy of a 3D Electrospun Synthetic Polymer Matrix on Hard-to-Heal Wounds.

INTRODUCTION: The aim of this study was to evaluate the efficacy of a 3D electrospun synthetic polymer matrix (3DESPM) on hard-to-heal wounds. MATERIALS AND METHODS: This prospective case series took place at four sites. The primary endpoints were the percentage area reduction (PAR) in wound area at four and eight weeks. Secondary endpoints included time to heal (Kaplan-Meier analysis) and the proportion of healed wounds at 12 weeks. After applying 3DESPM, the physician applied sterile saline, as appropriate, to adhere the matrix to the wound bed and facilitate the polymer degradation process. A nonadherent dressing, a secondary dressing, and additional bandages (as needed) were then applied. The physician left the product on the wound until complete degradation was observed, as appropriate, and reapplied, as appropriate. Combination advanced therapies were applied, per physician discretion. RESULTS: Thirty-eight patients (mean age: 64.3 years [SD: 17.6]) with 50 wounds (35 chronic, 70%) participated. The mean number of comorbidities per patient was 4.4 (2.3). All wounds received 3DESPM; 12 wounds (24%) received combination therapies; and 38 wounds (76%) completed the study. The mean (SD) PAR at four and eight weeks was 67.6% (38%) and 80% (35%), respectively. Thirty-three wounds (66%) healed at 12 weeks. The Kaplan-Meier mean time to heal for all wounds was 49.0 days (95% confidence interval: 41.3-56.7). CONCLUSIONS: In a complex patient population with severe comorbidities and heterogeneous wounds, 3DESPM appeared to accelerate the stalled healing process to contribute to wound closure. Further investigation of 3DESPM on a larger patient population and in a controlled setting is pending.

Coronary sinus electrogram characteristics predict termination of AF with ablation and long-term clinical outcome.

INTRODUCTION: Markers predicting atrial fibrillation (AF) termination and freedom from AF/atrial tachycardia (AT) has been proposed. This study aimed to evaluate the role of novel coronary sinus (CS) electrogram characteristics in predicting the acute ablation response and freedom from AF/AT during follow-up. METHODS: Patients undergoing ablation for persistent AF as part of the Stochastic Trajectory Analysis of Ranked signals mapping study were included. Novel CS electrogram characteristics including CS cycle length variability (CLV) and CS activation pattern stability (APS) and proportion of low voltage zones (LVZs) were reviewed as potential predictors for AF termination on ablation and freedom from AF/AT during follow-up. The relationship between localized driver characteristics and CS electrogram characteristics was also assessed. RESULTS: Sixty-five patients were included. AF termination was achieved in 51 patients and 80% of patients were free from AF/AT during a follow-up of 29.5 ± 3.7 months. CS CLV of <30 ms, CS APS of ≥30% and proportion of LVZ < 30% showed high diagnostic accuracy in predicting AF termination on ablation and freedom from AF/AT during follow-up (CS CLV odds ratio [OR] 25.6, area under the curve [AUC] 0.91; CS APS OR 15.9, AUC 0.94; proportion of LVZs OR 21.4, AUC 0.88). These markers were independent predictors of AF termination on ablation and AF/AT recurrence during follow-up. Ablation of a smaller number of drivers that demonstrate greater dominance strongly correlate with greater CS organization. CONCLUSION: Novel CS electrogram characteristics were independent predictors of AF termination and AF/AT recurrence during follow-up. These markers can potentially aid in predicting outcomes and guide ablation and follow-up strategies.

Ethanol ablation for ventricular arrhythmias: A systematic review and meta-analysis.

INTRODUCTION: Ethanol ablation (EA) is an alternative option for subjects with ventricular arrhythmias (VAs) refractory to conventional medical and ablative treatment. However, data on the efficacy and safety of EA remain sparse. METHODS: A systematic literature search was conducted. The primary outcomes were 1) freedom from the targeted VA and 2) freedom from any VAs post-EA. Additional safety outcomes were also analyzed. RESULTS: Ten studies were selected accounting for a population of 174 patients (62.3 ± 12.5 years, 94% male) undergoing 185 procedures. The overall acute success rate of EA was 72.4% (confidence interval [CI95% ]: 65.6-78.4). After a mean follow-up of 11.3 ± 5.5 months, the incidence of relapse of the targeted VA was 24.4% (CI95% : 17.1-32.8), while any VAs post-EA occurred in 41.3% (CI95% : 33.7-49.1). The overall incidence of procedural complications was 14.1% (CI95% : 9.8-19.8), with pericardial complications and complete atrioventricular block being the most frequent. An anterograde transarterial approach was associated with a higher rate of VA recurrences and complications compared to a retrograde transvenous route; however, differences in the baseline population characteristics and in the targeted ventricular areas should be accounted. CONCLUSION: EA is a valuable therapeutic option for VAs refractory to conventional treatment and can result in 1-year freedom from VA recurrence in 60%-75% of the patients. However, anatomical or technical challenges preclude acute success in almost 30% of the candidates and the rate of complication is not insignificant, highlighting the importance of well-informed patient selection. The certainty of the evidence is low, and further research is necessary.

ECG-I phenotyping of persistent AF based on driver burden and distribution to predict response to pulmonary vein isolation (PHENOTYPE-AF).

BACKGROUND: This prospective trial sought to phenotype persistent atrial fibrillation (AF) based on AF mechanisms using electrocardiographic imaging (ECGI) mapping to determine whether this would predict long-term freedom from arrhythmia after pulmonary vein isolation (PVI). METHODS: Patients with persistent AF of <2 years duration underwent cryoballoon PVI. ECGI mapping was performed before PVI to determine potential drivers (PDs) defined as rotational activations completing ≥1.5 revolutions or focal activations. The coprimary endpoint was the association between (1) PD burden (defined as the number of PD occurrences) and (2) PD distribution (defined as the number of segments on an 18-segment model of the atria harboring PDs) with freedom from arrhythmia at 1-year follow up. RESULTS: Of 100 patients, 97 completed follow up and 52 (53.6%) remained in sinus rhythm off antiarrhythmic drugs. Neither PD burden nor PD distribution predicted freedom from arrhythmia (hazard ratio [HR]: 1.01, 95% confidence interval [CI]: 0.99-1.03, p = .164; and HR: 1.04, 95% CI: 0.91-1.17, p = .591, respectively). Otherwise, the burden of rotational PDs, rotational stability, and the burden of PDs occurring at the pulmonary veins and posterior wall all failed to predict arrhythmia recurrence (all p > .10). CONCLUSIONS: AF mechanisms as determined using ECGI mapping do not predict outcomes after PVI for persistent AF. Further studies using different methodologies to characterize AF mechanisms are warranted (NCT03394404).

Transseptal puncture for left atrial ablation: Risk factors for cardiac tamponade and a proposed causative classification system.

AIMS: Cardiac tamponade is a high morbidity complication of transseptal puncture (TSP). We examined the associations of TSP-related cardiac tamponade (TRCT) for all patients undergoing left atrial ablation at our center from 2016 to 2020. METHODS AND RESULTS: Patient and procedural variables were extracted retrospectively. Cases of cardiac tamponade were scrutinized to adjudicate TSP culpability. Adjusted multivariate analysis examined predictors of TRCT. A total of 3239 consecutive TSPs were performed; cardiac tamponade occurred in 51 patients (incidence: 1.6%) and was adjudicated as TSP-related in 35 (incidence: 1.1%; 68.6% of all tamponades). Patients of above-median age [odds ratio (OR): 2.4 (1.19-4.2), p = .006] and those undergoing re-do procedures [OR: 1.95 (1.29-3.43, p = .042] were at higher risk of TRCT. Of the operator-dependent variables, choice of transseptal needle (Endrys vs. Brockenbrough, p > .1) or puncture sheath (Swartz vs. Mullins vs. Agilis vs. Vizigo vs. Cryosheath, all p > .1) did not predict TRCT. Adjusting for operator, equipment and demographics, failure to cross the septum first pass increased TRCT risk [OR: 4.42 (2.45-8.2), p = .001], whilst top quartile operator experience [OR: 0.4 (0.17-0.85), p = .002], transoesophageal echocardiogram [TOE prevalence: 26%, OR: 0.51 (0.11-0.94), p = .023], and use of the SafeSept transseptal guidewire [OR: 0.22 (0.08-0.62), p = .001] reduced TRCT risk. An increase in transseptal guidewire use over time (2016: 15.6%, 2020: 60.2%) correlated with an annual reduction in TRCT (R2 = 0.72, p < .001) and was associated with a relative risk reduction of 70%. CONCLUSIONS: During left atrial ablation, the risk of TRCT was reduced by operator experience, TOE-guidance, and use of a transseptal guidewire, and was increased by patient age, re-do procedures, and failure to cross the septum first pass.

PolarX Cryoballoon metrics predicting successful pulmonary vein isolation: targets for ablation of atrial fibrillation.

AIM: Evaluate the novel PolarX Cryoballoon in atrial fibrillation (AF) catheter ablation through a propensity-matched comparison with the Arctic Front Advance (AFA). The aim was also to identify cryoablation metrics that are predictive of successful pulmonary vein isolation (PVI) with the PolarX Cryoballoon. METHODS AND RESULTS: This prospective multi-centre study included patients that underwent cryoablation for AF. All patients underwent PVI with reconnection assessed after a 30-min waiting period and adenosine. Safety, efficacy, and cryoablation metrics were compared between PolarX and a propensity-matched AFA cohort. Seventy patients were included with 278 veins treated. In total, 359 cryoablations were performed (1.3 ± 0.6 per vein) to achieve initial PVI with 205 (73.7%) veins isolating with a single cryoablation. Independent predictors for achieving initial PVI included temperature at 30 s [odds ratio (OR) 1.26; P = 0.003] and time to reach -40°C (OR 1.88; P < 0.001) with an optimal cut-off of ≤-38.5°C at 30 s [area under the curve (AUC) 0.79; P < 0.001] and ≤-40°C at ≤32.5 s (AUC 0.77; P < 0.001), respectively. Of the 278 veins, 46 (16.5%) veins showed acute reconnection. Temperature at 30 s (≤-39.5°C, OR 1.24; P = 0.002), nadir temperature (≤-53.5°C, OR 1.35; P = 0.003), and time to isolation (≤38.0 s, OR 1.18; P = 0.009) were independent predictors of sustained PVI. Combining two of these three targets was associated with reconnection in only 2-5% of PVs. Efficacy and safety of the PolarX Cryoballoon were comparable to AFA Cryoballoon, however, cryoablation metrics were significantly different. CONCLUSIONS: The PolarX Cryoballoon has a different cryoablation profile to AFA Cryoballoon. Prospective testing of these proposed targets in large outcomes studies is required.

Risk factors for developing pacing induced LV dysfunction: Experience from a tertiary center in the UK.

BACKGROUND: The risk factors for developing pacing induced left ventricular dysfunction (LVD) in patients with high burden of right ventricular pacing (RVP) is poorly understood. Therefore, in the present study, we aimed to assess the determinants of pacing induced LVD. METHODS: Our data were retrospectively collected from 146 patients with RVP > 40% who underwent generator change (GC) or cardiac resynchronization therapy (CRT) upgrade between 2016 and 2019 who had left ventricular ejection fraction (EF) ≥50% at initial implant. RESULTS: A total of 75 patients had CRT upgrade due to pacing induced LVD (EF < 50%) and 71 patients with preserved LV function (EF ≥ 50%) had a GC. Primary indication for pacing in both groups was complete heart block. Male predominance (p = .008), prior myocardial infarction (MI) (p = .001), atrial fibrillation (AF) (p = .009), chronic kidney disease (CKD) (p = .005), and borderline low systolic function (BLSF) (EF 50%-55%) (p = .04) were more prevalent in the CRT upgrade group. Presence of AF (odds ratio [OR] = 3.05, 95% confidence interval [CI] 1.42-6.58; p = .004), BLSF (OR = 3.8, 95% CI 1.22-11.8; p = .02), and male gender (OR = 2.41, 95% CI 1.14-5.08; p = .02) were independent predictors for RVP induced LVD. Age (OR = 1.08, 95% CI 1.02-1.14; p = .005) and BLSF (OR = 5.33, 95% CI 1.26-22.5; p = .023) were independent predictors of earlier development of LVD after implant. CONCLUSIONS: Our results suggested that AF, BLSF, and male gender are predictors for development of pacing induced LVD in patients with high RVP burden. LVD can occur at any time after pacemaker implant with BLSF and increasing age associated with earlier development of LVD.

Early pacemaker implantation for transcatheter aortic valve implantation is safe and effective.

BACKGROUND: Permanent pacemaker (PPM) implantation is a common complication of transcatheter aortic valve implantation (TAVI). The optimum timing of PPM implantation is still unclear as conduction abnormalities evolve and a balance needs to be struck between conservative delays in the hope of conduction recovery and overutilization of pacing. This study aimed to assess the safety and efficacy of early PPM implantation, without an observation period, among TAVI patients. METHODS: This is a retrospective, observational study of 1398 TAVI patients. Clinical and pacing data were collected at baseline, 30 days and at a median of 15 (4-21) months post-TAVI. Study endpoints included PPM-related complications, pacing utilization and hospital length of stay. RESULTS: One hundred five patients (8.2%) required a PPM, of which 13 were implanted pre and 92 post-TAVI. Seventy-six percent required pacing for either second- or third-degree heart block. Time to implantation for post-TAVI PPM was 1 (0-3) day. Six patients experienced a pacing-related complication- lead displacement (n = 3), hematoma (n = 2), and device infection (n = 1). Pacing utilization defined as pacing >10% of the time or a pacing requirement at the time of the pacing check was demonstrated in 83% of patients. Multivariate analysis revealed complete heart block (CHB) was the only independent predictor of pacing utilization. Hospital length of stay for the post-TAVI PPM group was longer than the group without PPM (4 [2-8] vs. 3 [2-4] days; p < .001). CONCLUSIONS: Early PPM implantation in TAVI patients is safe and majority of patients require pacing in the short and mid-term.

Contemporary Practice and Optimising Referral Pathways for Implantable Cardiac Monitoring for Atrial Fibrillation after Cryptogenic Stroke.

OBJECTIVES: Diagnosing atrial fibrillation (AF) in patients following Cryptogenic stroke (CS) has therapeutic implications that can reduce the risk of further strokes. However, it's indolent and paroxysmal nature makes this challenging. Prolonged rhythm monitoring using implantable loop recorders (ILRs) can significantly increase the AF detection rate in the clinical trial paradigm. Whether this can be translated to real-world practice is unknown. An evaluation of referral pathways, workload and real-world efficacy may help select patients and inform service development. MATERIALS AND METHODS: Retrospective review of all patients with CS referred to a tertiary electrophysiology referral hospital for ILR implantation between February 2017 and October 2020 for AF detection was conducted. The electronic health record was used to determine demographic and mortality data. Remote monitoring was used to identify AF occurrence. RESULTS: 107 patients were included. The average time from stroke to ILR implantation was 10.5 (5.9-18.6) months. The average monitoring duration was 18.1 ± 11.2 months with 15 (14.0%) patients diagnosed with AF and commenced on anticoagulation. One diagnosis were made in the first 30 days whereas 11 (73%) were made within 12 months. Paroxysmal AF episodes ranged from 6 min to 13 h. Patients with CHA2DS2-VASc >3 were more likely to have AF (20.3% vs 4.7%, p = 0.02). Age was independently associated with AF detection after multi-variate regression. 352 ± 1171 unique events were recorded per patient, 75% of which were for suspected AF. External manufacturer-led triage of transmissions reduced transmission volume by 33%. CONCLUSIONS: ILR-based AF detection rate was high among referred CS patients, despite implantation occurring relatively late. Older patients may be less likely to be referred despite positive correlation between age and AF detection. Although recording algorithms and external triage reduced transmission volume, specialist analysis was required to manage the ILR event burden.

Ablation guided by STAR-mapping in addition to pulmonary vein isolation is superior to pulmonary vein isolation alone or in combination with CFAE/linear ablation for persistent AF.

INTRODUCTION: The optimal ablation approach for persistent atrial fibrillation (AF) remains unclear. METHODS AND RESULTS: Objective was to compare the long-term rates of freedom from AF/AT in patients that underwent STAR mapping guided ablation against outcomes of patients undergoing conventional ablation procedures. Patients undergoing ablation for persistent AF as part of the Stochastic Trajectory Analysis of Ranked signals (STAR) mapping study were included. Outcomes following 'pulmonary vein isolation (PVI) plus STAR mapping guided ablation (STAR mapping cohort) were compared to patients undergoing PVI alone ablation during the same time period and also a propensity-matched cohort undergoing PVI plus the addition of complex fractionated electrogram (CFAE) and/or linear ablation ("conventional ablation"). Rates of procedural AF termination and freedom from AF/AT during follow-up were compared. Sixty-five patients were included in both the STAR cohort and propensity matched conventional ablation cohort. AF termination rates were significantly higher in the STAR cohort (51/65, 78.5%) than conventional ablation cohort (10/65, 15.4%) and PVI alone ablation cohort (13/50, 26.0%; STAR cohort vs. other 2 cohorts both p < .001). There was no significant difference in procedure time between the three cohorts. During ≥20 months follow-up a lower proportion of patients had AF/AT recurrence in the STAR cohort (20.0%) compared with the conventional ablation cohort (50.8%) or the PVI alone ablation cohort (50.0%; both p < .05 compared to STAR cohort). CONCLUSIONS: Outcomes of PVI plus STAR mapping guided ablation was superior to PVI alone or in combination with linear/CFAE ablation. A multicenter randomized controlled trial is planned to confirm these findings.

First experience of POLARx™ versus Arctic Front Advance™: An early technology comparison.

INTRODUCTION: Cryoballoon ablation is an established technique to achieve pulmonary vein isolation in patients with atrial fibrillation (AF). Recently, a new manufacturer of cryoballoon achieved regulatory CE marking (POLARx™; Boston Scientific). We describe our early experience of using this new market entrant of the technology and describe procedural aspects in comparison to the incumbent Medtronic Arctic Front Advance™. METHODS: We assessed the first 40 AF ablations performed with the POLARx catheter at the Barts Heart Centre. These patients were compared with a contemporaneous series of patients undergoing ablation by the same operators using the Arctic Front Advance. Procedural metrics were prospectively recorded. RESULTS: A total of four operators undertook 40 cases using the POLARx catheter, compared with 40 cases using the Arctic Front Advance. Procedure times (60.0 vs. 60.0 min) were similar between the two technologies, however left atrial dwell time (35.0 vs 39.0 min) and fluoroscopy times (3.3 vs. 5.2 min) were higher with the POLARx. Measured nadir and isolation balloon temperatures were significantly lower with POLARx. Almost all veins were isolated with a median freezing time of 16.0 (POLARx) versus 15.0 (Arctic Front Advance) min. The rate of procedural complications was low in both groups. CONCLUSION: The POLARx cryoballoon is effective for pulmonary vein isolation. Measured isolation and nadir temperatures are lower compared with the predicate Arctic Front Advance catheter. The technology appears similar in acute efficacy and has a short learning curve, but formal dosing studies may be required to prove equivalence of efficacy.

Safety, effectiveness, and quality of life following pulmonary vein isolation with a multi-electrode radiofrequency balloon catheter in paroxysmal atrial fibrillation: 1-year outcomes from SHINE.

AIMS: To evaluate the safety and effectiveness of a compliant multi-electrode radiofrequency balloon catheter (RFB) used with a multi-electrode diagnostic catheter for pulmonary vein isolation (PVI). METHODS AND RESULTS: This prospective, multicentre, single-arm study was conducted at six European sites and enrolled patients with symptomatic paroxysmal atrial fibrillation. The primary effectiveness endpoint was entrance block in treated pulmonary veins (PVs) after adenosine/isoproterenol challenge. The primary safety endpoint was the occurrence of primary adverse events (PAEs) within 7 days. Cerebral magnetic resonance imaging and neurological assessments were performed pre- and post-ablation in a subset of patients. Atrial arrhythmia recurrence was assessed over 12 months via transtelephonic and Holter monitoring. Quality of life was assessed by the Atrial Fibrillation Effect on Quality of Life (AFEQT) questionnaire. Of 85 patients undergoing ablation per study protocol, PV entrance block was achieved in all (one PV required touch-up with a focal catheter). Acute reconnection of ≥1 PVs after adenosine/isoproterenol challenge was observed in 9.3% (30/324) of PVs ablated. Post-ablation, silent cerebral lesions were detected in 9.7% (3/31) of patients assessed, all of which was resolved at 1-month follow-up. One patient experienced a PAE (retroperitoneal bleed). Freedom from documented symptomatic and all arrhythmia was 72.2% and 65.8% at 12 months. Four patients (4.7%) underwent repeat ablation. Significant improvements in all AFEQT subscale scores were seen at 6 and 12 months. CONCLUSION: PVI with the novel RFB demonstrated favourable safety and effectiveness, with low repeat ablation rate and clinically meaningful improvement in quality of life. CLINICALTRIALS.GOV REGISTRATION NUMBER: NCT03437733.

Catheter ablation of atrial fibrillation in patients with hypertrophic cardiomyopathy: a European observational multicentre study.

AIMS: Atrial fibrillation (AF) is common in hypertrophic cardiomyopathy (HCM). Data on the efficacy of catheter ablation of AF in HCM patients are sparse. METHODS AND RESULTS: Observational multicentre study in 137 HCM patients (mean age 55.0 ± 13.4, 29.1% female; 225 ablation procedures). We investigated (i) the efficacy of catheter ablation for AF beyond the initial 12 months; (ii) the available risk scores, stratification schemes and genotype as potential predictors of arrhythmia relapse, and (iii) the impact of cryoballoon vs. radiofrequency in procedural outcomes. Mean follow-up was 43.8 ± 37.0 months. Recurrences after the initial 12-month period post-ablation were frequent, and 24 months after the index procedure, nearly all patients with persistent AF had relapsed, and only 40% of those with paroxysmal AF remained free from arrhythmia recurrence. The APPLE score demonstrated a modest discriminative capacity for AF relapse post-ablation (c-statistic 0.63, 95% CI 0.52-0.75; P = 0.022), while the risk stratification schemes for sudden death did not. On multivariable analysis, left atrium diameter and LV apical aneurysm were independent predictors of recurrence. Fifty-eight patients were genotyped; arrhythmia-free survival was similar among subjects with different gene mutations. Rate of procedural complications was high (9.3%), although reducing over time. Outcome for cryoballoon and radiofrequency ablation was comparable. CONCLUSION: Very late AF relapses post-ablation is common in HCM patients, especially in those with persistent AF. Left atrium size, LV apical aneurysm, and the APPLE score might contribute to identify subjects at higher risk of arrhythmia recurrence. First-time cryoballoon is comparable with radiofrequency ablation.

Post-operative cardiac implantable electronic devices in patients undergoing cardiac surgery: a contemporary experience.

AIMS: Optimum timing of pacemaker implantation following cardiac surgery is a clinical challenge. European and American guidelines recommend observation, to assess recovery of atrioventricular block (AVB) (up to 7 days) and sinus node (5 days to weeks) after cardiac surgery. This study aims to determine rates of cardiac implantable electronic devices (CIEDs) implants post-surgery at a high-volume tertiary centre over 3 years. Implant timing, patient characteristics and outcomes at 6 months including pacemaker utilization were assessed. METHODS AND RESULTS: All cardiac operations (n = 5950) were screened for CIED implantation following surgery, during the same admission, from 2015 to 2018. Data collection included patient, operative, and device characteristics; pacing utilization and complications at 6 months. A total of 250 (4.2%) implants occurred; 232 (3.9%) for bradycardia. Advanced age, infective endocarditis, left ventricle systolic impairment, and valve surgery were independent predictors for CIED implants (P < 0.0001). Relative risk (RR) of CIED implants and proportion of AVB increased with valve numbers operated (single-triple) vs. non-valve surgery: RR 5.4 (95% CI 3.9-7.6)-21.0 (11.4-38.9) CIEDs. Follow-up pacing utilization data were available in 91%. Significant utilization occurred in 82% and underutilization (<1% A and V paced) in 18%. There were no significant differences comparing utilization rates in early (≤day 5 post-operatively) vs. late implants (P = 0.55). CONCLUSION: Multi-valve surgery has a particularly high incidence of CIED implants (14.9% double, 25.6% triple valve). Age, left ventricle systolic impairment, endocarditis, and valve surgery were independent predictors of CIED implants. Device underutilization was infrequent and uninfluenced by implant timing. Early implantation (≤5 days) should be considered in AVB post-multi-valve surgery.

Leadless left ventricular endocardial pacing for CRT upgrades in previously failed and high-risk patients in comparison with coronary sinus CRT upgrades.

AIMS: Cardiac resynchronization therapy (CRT) upgrades may be less likely to improve following intervention. Leadless left ventricular (LV) endocardial pacing has been used for patients with previously failed CRT or high-risk upgrades. We compared procedural and long-term outcomes in patients undergoing coronary sinus (CS) CRT upgrades with high-risk and previously failed CRT upgrades undergoing LV endocardial upgrades. METHOD AND RESULTS: Prospective consecutive CS upgrades between 2015 and 2019 were compared with those undergoing WiSE-CRT implantation. Cardiac resynchronization therapy response at 6 months was defined as improvement in clinical composite score (CCS) and a reduction in LV end-systolic volume (LVESV) ≥15%. A total of 225 patients were analysed; 121 CS and 104 endocardial upgrades. Patients receiving WiSE-CRT tended to have more comorbidities and were more likely to have previous cardiac surgery (30.9% vs. 16.5%; P = 0.012), hypertension (59.2% vs. 34.7%; P < 0.001), chronic obstructive airways disease (19.4% vs. 9.9%; P = 0.046), and chronic kidney disease (46.4% vs. 21.5%; P < 0.01) but similar LV ejection fraction (30.0 ± 8.3% vs. 29.5 ± 8.6%; P = 0.678). WiSE-CRT upgrades were successful in 97.1% with procedure-related mortality in 1.9%. Coronary sinus upgrades were successful in 97.5% of cases with a 2.5% rate of CS dissection and 5.6% lead malfunction/displacement. At 6 months, 91 WiSE-CRT upgrades and 107 CS upgrades had similar improvements in CCS (76.3% vs. 68.5%; P = 0.210) and reduction in LVESV ≥15% (54.2% vs. 56.3%; P = 0.835). CONCLUSION: Despite prior failed upgrades and high-risk patients with more comorbidities, WiSE-CRT upgrades had high rates of procedural success and similar improvements in CCS and LV remodelling with CS upgrades.