Accuracy of left atrial bipolar voltages obtained by ConfiDENSE multielectrode mapping in patients with persistent atrial fibrillation.

INTRODUCTION: The ConfiDENSE™ module (Carto3 v4) allows rapid annotation of endocardial electrograms acquired by multielectrode (ME) mapping. However, its accuracy in assessing atrial voltages is unknown. METHODS AND RESULTS: Two ConfiDENSE™ left atrial voltage maps were created during continuous pacing in 20 patients undergoing catheter ablation for persistent AF using a ME lasso catheter and a contact force (CF) sensing ablation catheter. The automated tissue proximity indicator (TPI) filter was then applied to the ME map to yield a TPI map. Reference maps (RM) were created offline by a blinded observer by manually assessing all points against fidelity criteria. Bipolar voltages and proportion of low voltage points (< 0.5 mV) derived from the ME, CF, and TPI maps were compared with those derived from the RM. Note that 853 ± 365 points, 252 ± 184 points, and 144 ± 73 were collected for ME, TPI, and CF maps, respectively, and 429 ± 153 points were included in the RM. Voltages with CF and TPI maps were similar to those with RM (1.57 ± 0.47 mV vs. 1.63 ± 0.31 mV, P = 0.57 and 1.50 ± 0.38 mV vs. 1.63 ± 0.31 mV, P = 0.07, respectively), whereas ME maps showed a significantly lower mean voltage (1.00 ± 0.22 mV, P < 0.001). As compared to RM maps (17 ± 8%), low voltage points were significantly overestimated by the ME maps (50 ± 9% (P < 0.001) and TPI maps (28 ± 13% (P < 0.001), but not by the CF maps (22 ± 14%, P = 0.17). CONCLUSION: Application of the TPI filter to ConfiDENSE maps significantly increases the quality of the voltage data, conserving a reasonable point density, but still overestimates low voltage points as compared to CF-sensing maps or maps reviewed manually.

Prospective use of Ablation Index targets improves clinical outcomes following ablation for atrial fibrillation.

AIMS: Late recovery of ablated tissue leading to reconnection of pulmonary veins remains common following radiofrequency catheter ablation for AF. Ablation Index (AI), a novel ablation quality marker, incorporates contact force (CF), time, and power in a weighted formula. We hypothesized that prospective use of our previously published derived AI targets would result in better outcomes when compared to CF-guided ablation. METHODS: Eighty-nine consecutive drug-refractory AF patients (49% paroxysmal) underwent AI-guided ablation (AI-group). AI targets were 550 for anterior/roof and 400 for posterior/inferior left atrial segments. Procedural and clinical outcomes of these patients were compared to 89 propensity-matched controls who underwent CF-guided ablation (CF-group). All 178 procedures were otherwise similar, and both groups were followed-up for 12 months. The last 25 patients from each group underwent analysis of all VisiTags™ for ablation duration, CF, Force-Time Integral, and impedance drop. RESULTS: First-pass pulmonary vein isolation (PVI) was more frequent in AI-group than in CF-group (173 [97%] vs. 149 [84%] circles, P < 0.001), and acute PV reconnection was lower (11 [6%] vs. 24 [13%] circles, P = 0.02). Mean PVI ablation time was similar (AI-group: 42 ± 9 vs. CF-group: 45 ± 14 minutes, P = 0.14). Median impedance drop for AI-group was significantly higher than in CF-group (13.7 [9-19] Ω vs. 8.8 [5.2-13] Ω, P < 0.001). Two major complications occurred in CF-group and none in AI-group. Atrial tachyarrhythmia recurrence was significantly lower in AI-group (15 of 89 [17%]) than in CF-group (33 of 89 [37%], P = 0.002). CONCLUSION: AI-guided ablation is associated with significant improvements in the incidence of acute PV reconnection and atrial tachyarrhythmia recurrence rate compared to CF-guided ablation, potentially due to creation of better quality lesions as suggested by greater impedance drop.

Reablated Sites of Acute Reconnection After Pulmonary Vein Isolation Do Not Predict Sites of Late Reconnection at Repeat Electrophysiology Study.

INTRODUCTION: Acute reconnection of pulmonary veins (PVs) is frequently seen in the waiting period following pulmonary vein isolation (PVI). There are concerns that reablation at these sites may not be durably effective due to tissue edema caused by the initial ablation. We aimed to prospectively study the relationship between acute and late reconnection. METHODS AND RESULTS: Wide-area circumferential PVI was performed in 40 paroxysmal AF patients. Spontaneous reconnection was assessed after a minimum 20-minute waiting period, with adenosine administered to unmask dormant reconnection. All sites of acute reconnection were ablated to reisolate the PV. All 40 patients then underwent repeat electrophysiology study after 2 months, regardless of symptoms, to identify late reconnection. Sites of acute and late reconnection were compared according to a 12-segment PVI model. Acute reconnection was seen in 28 (6%) PVI segments in 20 (50%) patients, affecting 24/160 (15%) PVs. All were successfully reisolated. At repeat electrophysiology study, 51 (11%) PVI segments were reconnected in 25 (62%) patients, affecting 41 (25%) PVs. The proportion of PVI segments with and without acute reconnection exhibiting late reconnection at repeat study was no different (14% vs. 10%, P = 0.524). There was also no difference in late reconnection between PVI circles or patients with and without acute reconnection. CONCLUSION: Most PVI segments that undergo further ablation for acute reconnection show persistent isolation at repeat electrophysiology study, and the rate of late reconnection for these segments is no different to that for segments that did not acutely reconnect. This implies that effective reablation is delivered at these sites.

Cryoballoon pulmonary vein isolation as first-line treatment of typical atrial flutter: long-term outcomes of the CRAFT trial.

BACKGROUND: CRAFT was an international, multicentre, randomised controlled trial across 11 sites in the United UK and Switzerland. Given the evidence that pulmonary vein triggers may be responsible for atrial flutter (AFL) as well as atrial fibrillation (AF), we hypothesised that cryoballoon pulmonary vein isolation (PVI) would provide greater symptomatic arrhythmia reduction than cavotricuspid isthmus (CTI) ablation, whilst also reducing the subsequent burden of AF. Twelve-month outcomes were previously reported. In this study, we report the extended outcomes of the CRAFT study to 36 months. METHODS: Patients with typical AFL and no evidence of AF were randomised 1:1 to cryoballoon PVI or radiofrequency CTI. All patients received an implantable loop recorder (ILR) for continuous cardiac rhythm monitoring. The primary outcome was time-to-symptomatic arrhythmia recurrence > 30 s. Secondary outcomes included time-to-first-AF episode ≥ 2 min. The composite safety outcome included death, stroke and procedural complications. RESULTS: A total of 113 patients were randomised to cryoballoon PVI (n = 54) or radiofrequency CTI ablation (n = 59). Ninety-one patients reconsented for extended follow-up beyond 12 months. There was no difference in the primary outcome between arms, with the primary outcome occurring in 12 PVI vs 11 CTI patients (HR 0.97; 95% CI 0.43-2.20; p = 0.994). AF ≥ 2 min was significantly less frequent in the PVI arm, affecting 26 PVI vs 36 CTI patients (HR 0.48; 95% CI 0.29-0.79; p = 0.004). The composite safety outcome occurred in 5 PVI and 6 CTI patients (p = 0.755). CONCLUSION: Cryoballoon PVI shows similar efficacy to radiofrequency CTI ablation in reducing symptomatic arrhythmia recurrence in patients presenting with isolated typical AFL but significantly reduces the occurrence of subsequent AF.

Cryoballoon Pulmonary Vein Isolation as First-Line Treatment for Typical Atrial Flutter.

OBJECTIVE: We aimed to compare cryoballoon pulmonary vein isolation (PVI) with standard radiofrequency cavotricuspid isthmus (CTI) ablation as first-line treatment for typical atrial flutter (AFL). METHODS: Cryoballoon Pulmonary Vein Isolation as First-Line Treatment for Typical Atrial Flutter was an international, multicentre, open with blinded assessment trial. Patients with CTI-dependent AFL and no documented atrial fibrillation (AF) were randomised to either cryoballoon PVI alone or radiofrequency CTI ablation. Primary efficacy outcome was time to first recurrence of sustained (>30 s) symptomatic atrial arrhythmia (AF/AFL/atrial tachycardia) at 12 months as assessed by continuous monitoring with an implantable loop recorder. Primary safety outcome was a composite of death, stroke, tamponade requiring drainage, atrio-oesophageal fistula, pacemaker implantation, serious vascular complications or persistent phrenic nerve palsy. RESULTS: Trial recruitment was halted at 113 of the target 130 patients because of the SARS-CoV-2 pandemic (PVI, n=59; CTI ablation, n=54). Median age was 66 (IQR 61-71) years, with 98 (86.7%) men. At 12 months, the primary outcome occurred in 11 (18.6%) patients in the PVI group and 9 (16.7%) patients in the CTI group. There was no significant difference in the primary efficacy outcome between the groups (HR 1.11, 95% CI 0.46 to 2.67). AFL recurred in six (10.2%) patients in the PVI arm and one (1.9%) patient in the CTI arm (p=0.116). Time to occurrence of AF of ≥2 min was significantly reduced with cryoballoon PVI (HR 0.46, 95% CI 0.25 to 0.85). The composite safety outcome occurred in four patients in the PVI arm and three patients in the CTI arm (p=1.000). CONCLUSION: Cryoballoon PVI as first-line treatment for AFL is equally effective compared with standard CTI ablation for preventing recurrence of atrial arrhythmia and better at preventing new-onset AF. TRIAL REGISTRATION NUMBER: NCT03401099.

Cryoballoon pulmonary vein isolation as first line treatment for typical atrial flutter (CRAFT): study protocol for a randomised controlled trial.

PURPOSE: Treatment of typical atrial flutter (AFL) with cavo-tricuspid isthmus (CTI) ablation is associated with a high occurrence rate of new onset atrial fibrillation (AF) during follow-up. There are data to support the addition of pulmonary vein isolation (PVI) to CTI ablation in patients with both AF and AFL, but the role of cryoballoon PVI only, with no CTI ablation, in AFL patients with no prior documentation of AF has not been studied. METHODS: CRAFT is an international, prospective, randomised, open with blinded assessment, multicentre superiority study comparing radiofrequency CTI ablation and cryoballoon PVI in patients with typical AFL. Participants with typical AFL are randomised in a 1:1 ratio to either treatment arm, with patients randomised to PVI not receiving CTI ablation. Post-procedural cardiac monitoring is performed using an implantable loop recorder. The primary endpoint is time to first recurrence of sustained symptomatic atrial arrhythmia. Key secondary endpoints include (1) total arrhythmia burden at 12 months, (2) time to first episode of AF lasting ≥ 2 min, (3) time to recurrence of AFL or AT and (4) procedural and fluoroscopy times. The primary safety endpoint is the composite of death, stroke/transient ischaemic attack, cardiac tamponade requiring drainage, atrio-oesophageal fistula, requirement for a permanent pacemaker, serious vascular complications requiring intervention or delaying discharge and persistent phrenic nerve palsy lasting > 24 h. CONCLUSION: This study compares the outcomes of 2 different approaches to typical AFL-the conventional 'substrate'-based strategy of radiofrequency CTI ablation versus a novel 'trigger'-based strategy of cryoballoon PVI. TRIAL REGISTRATION: ( ClinicalTrials.gov ID: NCT03401099 ).

Reverse electrical and structural remodeling of the left atrium occurs early after pulmonary vein isolation for persistent atrial fibrillation.

PURPOSE: Adverse left atrial (LA) remodeling is known to be associated with persistent atrial fibrillation (PeAF). The time course and pattern of reversal of LA remodeling following catheter ablation is poorly understood. We aimed to evaluate LA chamber volumes and dimensions, LA conduction velocities, and LA bipolar voltages at baseline and at 2 months after catheter ablation for PeAF. METHODS: Twenty-three patients with PeAF underwent detailed LA mapping during fixed rate atrial pacing using the CARTO3 navigation system prior to undergoing pulmonary vein isolation. All patients returned for protocol-mandated repeat electrophysiology study at 2 months, irrespective of symptoms or arrhythmia recurrence, during which all measurements were repeated using an identical mapping protocol. Patients then underwent daily ECG monitoring for 12 months. RESULTS: Nineteen out of twenty-three (83.6%) patients had durable PVI of all veins at repeat electrophysiology study, while 4 (17.4%) patients had late reconnection of a single vein each. In the blinded offline analysis, LA volume at follow-up was significantly lower as compared with baseline (55 ± 14 mL/m2 vs. 65 ± 15 mL/m2, P < 0.001). LA conduction velocities were significantly greater at 2 months (0.90 ± 0.13 m/s vs. 0.78 ± 0.13 m/s, P = 0.01). There was non-uniform regional LA voltage evolution, with a significant increase in bipolar voltages observed on the LA posterior wall (2.18 ± 0.85 mV vs. 1.83 ± 0.49 mV, P = 0.04), but not elsewhere. Individual variables of remodeling were not associated with AF recurrence. CONCLUSION: Significant structural and electrical reverse remodeling of the LA can be seen as early as 2 months following successful catheter ablation for PeAF.

Use of Ablation Index-Guided Ablation Results in High Rates of Durable Pulmonary Vein Isolation and Freedom From Arrhythmia in Persistent Atrial Fibrillation Patients: The PRAISE Study Results.

Background Catheter ablation for persistent atrial fibrillation (AF) is associated with less favorable outcomes than for paroxysmal AF. Substrate modification is often added to pulmonary vein isolation (PVI) to try to improve success rates. Recent studies have shown improved clinical outcomes with use of regional ablation index (AI) targets for PVI. We hypothesized that prospective use of AI-guided PVI in persistent AF patients would result in a low rate of PV reconnection at repeat electrophysiology study and that a high success rate can be achieved with durable PVI alone. Methods Forty consecutive patients with persistent AF underwent AI-guided PVI with target values of 550 for anterior and 400 for posterior left atrial regions, followed by a protocol-mandated repeat procedure after 2 months. Patients were monitored for atrial tachyarrhythmia recurrence via daily plus symptom-initiated ECG recordings for 12 months. Recurrence was defined as ≥30 seconds of any atrial tachyarrhythmia after a 3-month blanking period. Results PV reconnection was seen at repeat electrophysiology study in 22% of patients, affecting 7% of PVs. Ablation on the intervenous carina was required in 44% patients to achieve durable PVI. Atrial tachyarrhythmia recurrence was documented in 8 (20%) patients, only one of whom had PV reconnection at repeat study. At 12 months, 38/40 (95%) patients were in sinus rhythm, with 4 (10%) patients having started antiarrhythmic drugs. Higher body mass index and excess alcohol consumption were the only significant factors associated with atrial tachyarrhythmia recurrence. Conclusions Use of AI targets results in a high level of durable PVI. A good clinical outcome can be achieved in the great majority of persistent AF patients with AI-guided PVI alone. Clinical Trial Registration URL: https://www.clinicaltrials.gov . Unique identifier: NCT02628730.

Pulmonary Vein Re-Isolation as a Routine Strategy Regardless of Symptoms: The PRESSURE Randomized Controlled Trial.

OBJECTIVES: The goal of this study was to determine whether a strategy of early re-isolation of pulmonary vein (PV) reconnection in all patients, regardless of symptoms, would reduce the recurrence of atrial fibrillation (AF) and improve quality of life. BACKGROUND: Lasting pulmonary vein isolation (PVI) remains elusive. PV reconnection is strongly linked to the recurrence of arrhythmia. METHODS: A total of 80 patients with paroxysmal AF were randomized 1:1 after contact force-guided PVI to receive either standard care or undergo a repeat electrophysiology study after 2 months regardless of symptoms (repeat study). At the initial procedure, PVI was demonstrated by entrance/exit block and adenosine administration after a minimum 20-min wait. At the repeat study, all sites of PV reconnection were re-ablated. Patients recorded electrocardiograms daily and whenever symptomatic for 12 months using a handheld monitor. Recurrence was defined as ≥30 s of atrial tachyarrhythmia (AT) after a 3-month blanking period. The Atrial Fibrillation Effect on Quality-of-Life Questionnaire was completed at baseline and at 6 and 12 months. RESULTS: All 40 patients randomized to repeat study attended for this after 62 ± 6 days, of whom 25 (62.5%) had reconnection of 41 (26%) PVs. There were no complications related to these procedures. Subjects recorded a total of 32,203 electrocardiograms (380 [335 to 447] per patient) during 12.6 (12.2 to 13.2) months of follow-up. AT recurrence was significantly lower for the repeat study group (17.5% vs. 42.5%; p = 0.03), as was AT burden (p = 0.03). Scores on the Atrial Fibrillation Effect on Quality-of-Life Questionnaire were higher in the repeat study group at 6 months (p < 0.001) and 12 months (p = 0.02). CONCLUSIONS: A strategy of routine repeat assessment with re-isolation of PV reconnection improved freedom from AT recurrence, AT burden, and quality of life compared with current standard care. (The Effect of Early Repeat Atrial Fibrillation [AF] on AF Recurrence [PRESSURE]; NCT01942408).

A phenomenological study to understand the experiences of nurses with regard to brainstem death.

METHOD: In this study six nurses from general intensive care units were interviewed. The resulting transcripts were analysed using hermeneutic phenomenology. FINDINGS: The findings fall into five categories, feelings, communication, protection, education, and technology. Nurses appear to suffer a degree of cognitive dissonance that both adds to their stress and leads to difficulties in explaining brainstem death to relatives. CONCLUSION: Nurses need more education and support to enable them to overcome cognitive dissonance and so give relatives honest information. Verbal information should be supplemented with a written information leaflet given to all relatives.