A Randomized Trial of Electrographic Flow-Guided Redo Ablation for Nonparoxysmal Atrial Fibrillation (FLOW-AF).

BACKGROUND: Electrographic flow (EGF) mapping enables full spatiotemporal reconstruction of organized wavefront propagation to identify extrapulmonary vein sources of atrial fibrillation (AF). OBJECTIVES: FLOW-AF (A Randomized Controlled Study to Evaluate the Reliability of the Ablacon Electrographic FLOW [EGF] Algorithm Technology [Ablamap Software] to Identify AF Sources and Guide Ablation Therapy in Patients With Persistent Atrial Fibrillation) was multicenter, randomized controlled study of EGF mapping to: 1) stratify a nonparoxysmal AF population undergoing redo ablation; 2) guide ablation of these extrapulmonary vein AF sources; and 3) improve AF recurrence outcomes. METHODS: FLOW-AF enrolled persistent atrial fibrillation (PerAF)/long-standing PerAF patients undergoing redo ablation at 4 centers. One-minute EGF maps were recorded from standardized biatrial basket positions. Patients with source activity ≥26.5% were randomized 1:1 to PVI + EGF-guided ablation vs PVI only; patients without sources ≥26.5% threshold were not randomized. Follow-up and electrocardiographic monitoring occurred at 3, 6, and 12 months. RESULTS: We enrolled 85 patients (age 65.6 ± 9.3 years, 37% female, 24% long-standing PerAF). Thirty-four (40%) patients had no sources greater than threshold; at least 1 source greater than threshold was present in 46 (60%) (EGF-guided ablation, n = 22; control group, n = 26). Patients with sources were older (68.2 vs 62.6 years; P = 0.005) with higher CHA2DS2-VASc scores (2.8 vs 1.9; P = 0.001). The freedom from safety events was 97.2%, and 95% of EGF-identified sources were successfully ablated. In randomized patients, AF-free survival at 12 months was 68% for EGF-guided ablation vs 17% for the control group (P = 0.042); freedom from AF/atrial tachycardia/atrial flutter at 12 months was 51% vs 14% (P = 0.103), respectively. CONCLUSIONS: In nonparoxysmal AF patients undergoing redo ablation, EGF mapping identified AF sources in 60% of patients, and could be successfully ablated in 95%. Compared with PVI alone, PVI + source ablation improved AF-free survival by 51% on an absolute basis. (FLOW-AF: A Study to Evaluate the Ablacon Electrographic FLOW EGF Technology [A Randomized Controlled Study to Evaluate the Reliability of the Ablacon Electrographic FLOW (EGF) Algorithm Technology (Ablamap Software) to Identify AF Sources and Guide Ablation Therapy in Patients With Persistent Atrial Fibrillation]; NCT04473963).

Incidence of ventricular arrhythmias in patients with chronic total coronary occlusion: Results of the VACTOR study.

Background: A chronic total coronary occlusion (CTO) is associated with ventricular arrhythmias (VA) in patients with an implantable cardioverter-defibrillator (ICD). Limited data is available on the incidence of VA in CTO patients without an ICD. Objectives: To investigate the incidence of sustained VA in CTO patients after successful CTO revascularization and in patients with untreated CTO or failed CTO revascularization. Methods: Prospective, multicenter observational pilot study including CTO patients who were not eligible for an ICD and had a left ventricular ejection fraction >35 %. We enrolled patients with a successful CTO revascularization (group A) and patients with untreated CTO or failed CTO revascularization (group B). All patients received an implantable loop recorder with remote monitoring. The primary endpoint was sustained VA. Results: Ninety patients were enrolled (mean age 63 ± 10 years, 83.3 % man, mean LVEF 55 ± 8 %). Group A (n = 45) had a higher prevalence of CTO in the left anterior descending artery in comparison to group B (n = 45) (28.9 % versus 4.4 %, P = 0.002). Other baseline characteristics were similar. During a median follow-up time of 26 months (IQR, 19-35), five patients (5.6 %) had a sustained VA. There was no difference in the incidence of sustained VA between groups (3-year cumulative event rate: 8.8 % (group A) versus 4.5 % (Group B), log-rank P = 0.71). Conclusion: Patients with an CTO, who do not qualify for an ICD, have a substantial risk of sustained VA. In our study the incidence was not different between patients with revascularized and those with untreated CTO.

Device infection in patients undergoing pacemaker or defibrillator surgery: risk stratification using the PADIT score.

BACKGROUND: The use of an antibacterial envelope is cost-effective for patients at high risk of developing cardiac implantable electronic device (CIED) infection. The identification of these high-risk patients may be facilitated using a clinical risk score. The aim of the current study is to evaluate the PADIT score for identifying high-risk patients in patients undergoing a CIED procedure in a tertiary academic center. METHODS: This was a retrospective single-center study of consecutive patients undergoing a CIED procedure between January 2016 and November 2021. Patients who received an antibacterial envelope were excluded from this study. The primary endpoint was hospitalization for a CIED infection in the first year after the procedure. RESULTS: A total of 2333 CIED procedures were performed in the study period (mean age 61.6 ± 16.3 years, male sex 64.5%, previous CIED infection 1.7%, immunocompromised 5.4%). The median PADIT score was 4 (interquartile range, 2-6). CIED infection occurred in 10 patients (0.43%). The PADIT score had good discrimination in predicting major CIED infection (C-statistic 0.70; 95% confidence interval [CI] 0.54 to 0.86, P = 0.03). Using an optimal PADIT score cut-off value of 7, the risk of CIED infection was higher in the patients with a PADIT score of ≥ 7 in comparison to those with a lower PADIT score (1.23% vs. 0.26%, P = 0.02; odds ratio 4.8, 95% CI 1.4 to 16.6, P = 0.01). CONCLUSIONS: The PADIT score is a clinically useful score for identifying patients at high risk of developing CIED infection. The use of an antibacterial envelope in these high-risk patients may be cost-effective.

Robotic magnetic navigation-guided catheter ablation establishes highly effective pulmonary vein isolation in patients with paroxysmal atrial fibrillation when compared to conventional ablation techniques.

INTRODUCTION: Pulmonary vein isolation (PVI) is a pivotal part of ablative therapy for atrial fibrillation (AF). Currently, there are multiple techniques available to realize PVI, including: manual-guided cryoballoon (MAN-CB), manual-guided radiofrequency (MAN-RF), and robotic magnetic navigation-guided radiofrequency ablation (RMN-RF). There is a lack of large prospective trials comparing contemporary RMN-RF with the more conventional ablation techniques. This study prospectively compared three catheter ablation techniques as treatment of paroxysmal AF. METHODS: This multicenter, prospective study included patients with paroxysmal AF who underwent their first ablation procedure. Procedural parameters (including procedural efficiency), complication rates, and freedom of AF during 12-month follow-up, were compared between three study groups which were defined by the utilized ablation technique. RESULTS: A total of 221 patients were included in this study. Total procedure time was significantly shorter in MAN-CB (78 ± 21 min) compared to MAN-RF (115 ± 41 min; p < .001) and compared to RMN-RF (129 ± 32 min; p < .001), whereas it was comparable between the two radiofrequency (RF) groups (p = .062). A 3% complication rate was observed, which was comparable between all groups. At 12-month follow-up, AF recurrence was observed in 40 patients (19%) and was significantly lower in the robotic group (MAN-CB 19 [24%], MAN-RF 16 [23%], RMN-RF 5 [8%] AF recurrences, p = .045) (multivariate hazard ratio of RMN-RF on AF recurrence 0.32, 95% confidence interval: 0.12-0.87, p = .026). CONCLUSION: RMN-guided PVI results in high freedom of AF in patients with paroxysmal AF, when compared to cryoablation and manual RF ablation. Cryoablation remains the most time-efficient ablation technique, whereas RMN nowadays has comparable efficiency with manual RF ablation.

Electrographic flow mapping guided catheter ablation offers advantages for patients with persistent atrial fibrillation.

BACKGROUND: Catheter ablation (CA) remains challenging due to suboptimal success rates in persistent atrial fibrillation (AF). Existing mapping technologies cannot reliably distinguish sources in this patient population. Recently, the novel electrographic flow (EGF) mapping system was developed using a modified Horn-Schunk optical flow algorithm to detect and quantify patterns of electrical wavefront propagation in the atria. OBJECTIVES: To test the hypothesis that targeted source ablation based on EGF mapping is superior to empiric AF ablation. METHODS: We included all consecutive patients undergoing EGF guided ablation for persistent AF. All patients underwent pulmonary vein isolation (PVI) and were treated with the same EAM system (CARTO). The outcome of PVI+EGF guided CA was compared with data of PVI-only procedures (PVI-only group) and PVI plus additional empiric adjunctive linear and substrate ablations (PVI+LINES group). 12-months outcome as freedom from AF and atrial tachycardia/flutter (AT/AFL), procedural safety and efficiency characterized by procedure duration, fluoroscopy use, radiofrequency applications and duration, were analyzed. Both intention-to-treat and per protocol analysis were conducted. RESULTS: A total number of 70 patients (39 in PVI+EGF, 16 in PVI-only and 15 patients in PVI+LINES group) were enrolled. Intention-to-treat analysis showed fewer AF recurrences in PVI+EGF as compared with the PVI-only or PVI+LINES groups at 12 months (25.6% vs. 62.5% vs. 53.3%, p = .02). There were no differences in AT/AFL recurrence (17.9% vs. 37.5% vs. 20.0%, p = .37). Procedure times were longer in PVI+EGF group (p < .01), and there were no differences in fluoroscopy use (p = .67). CONCLUSION: Our data suggest that patients treated with EGF-guided CA developed fewer AF recurrences. Although the procedure times are longer, it seems to be safe and offers a more targeted, patient-specific ablation strategy beyond PVI than adjunctive empiric lines and substrate ablation in this complex group of patients.

Electrographic flow-guided ablation in redo patients with persistent atrial fibrillation (FLOW-AF): design and rationale.

Background: Electrographic flow (EGF) mapping enables the dynamic detection of functional or active atrial fibrillation (AF) sources outside the pulmonary veins (PVs), and the presence or absence of these sources offers a novel framework for classifying and treating persistent AF patients based on the underlying pathophysiology of their AF disease. Objective: The primary objective of the FLOW-AF trial is to evaluate the reliability of the EGF algorithm technology (Ablamap software) to identify AF sources and guide ablation therapy in patients with persistent AF. Methods: The FLOW-AF trial (NCT04473963) is a prospective, multicenter, randomized clinical study in which patients with persistent or long-standing persistent AF who have failed prior PV isolation (PVI) undergo EGF mapping after confirmation of intact PVI. In total, 85 patients will be enrolled and stratified based on the presence or absence of EGF-identified sources. Patients with an EGF-identified source above the predetermined activity threshold of ≥26.5% will be randomized in a 1:1 fashion to PVI only vs PVI + ablation of EGF-identified extra-PV sources of AF. Results: The primary safety endpoint is freedom from serious adverse events related to the procedure through 7 days following the randomization procedure; and the primary effectiveness endpoint is the successful elimination of significant sources of excitation with the target parameter the activity of the leading source. Conclusions: The FLOW-AF trial is a randomized study designed to evaluate the ability of the EGF mapping algorithm to identify patients with active extra-PV AF sources.

Long-term safety and efficacy of renal sympathetic denervation in atrial fibrillation: 3-year results of the AFFORD study.

BACKGROUND: Atrial fibrillation (AF) is the most common sustained arrhythmia which has been associated with increased sympathetic nervous system activity and hypertension. Recent evidence indicated that renal sympathetic denervation (RDN) could safely contribute to an improvement in AF burden. OBJECTIVE: To investigate the long-term safety and efficacy of radiofrequency RDN in hypertensive patients with symptomatic AF. METHODS: This pilot study included patients with symptomatic paroxysmal or persistent AF (European Hearth Rhythm Association class ≥ II) despite optimal medical therapy, office systolic blood pressure (BP) ≥ 140 mmHg and ≥ 2 antihypertensive drugs. AF burden was measured using an implantable cardiac monitor (ICM), implanted 3 months prior to RDN. ICM interrogation and 24-h ambulatory BP monitoring were performed at baseline and at 3/6/12/24/36 months post RDN. The primary efficacy outcome was daily AF burden. Statistical analyses were performed using Poisson and negative binomial models. RESULTS: A total of 20 patients with a median age [25th-75th percentiles] of 66.2 [61.2-70.8] years (55% female) were included. At baseline, office BP ± standard deviation (SD) was 153.8/87.5 ± 15.2/10.4 mmHg, while mean 24-h ambulatory BP was 129.5/77.3 ± 15.5/9.3 mmHg. Baseline daily AF burden was 1.4 [0.0-10.9] minutes/day and throughout a 3-year follow-up period, no significant change was observed (- 15.4%/year; 95% confidence interval (CI) - 50.2%, + 43.7%; p = 0.54). The number of defined daily doses of antiarrhythmic drugs and antihypertensive drugs remained stable over time, while mean 24-h ambulatory systolic BP decreased with - 2.2 (95% CI - 3.9, - 0.6; p = 0.01) mmHg/year. CONCLUSIONS: In patients with hypertension and symptomatic AF, stand-alone RDN reduced BP but did not significantly reduce AF burden up until 3 years of follow-up.

Single-beat global atrial mapping facilitates the treatment of short-lived atrial tachycardias and infrequent premature atrial contractions.

BACKGROUND: Short runs of atrial tachycardias (ATs) and infrequent premature atrial contractions (PACs) are difficult to map and ablate using sequential electrophysiology mapping techniques. The AcQMap mapping system allows for highly accurate mapping of a single atrial activation. OBJECTIVES: We aimed to test the value of a novel dipole charge density-based high-resolution mapping technique (AcQMap) in the treatment of brief episodes of ATs and PACs. METHODS: Data of all patients undergoing catheter ablation (CA) using the AcQMap mapping system were reviewed. RESULTS: Thirty-one out of 219 patients (male n = 8; female n = 23) had short runs of ATs (n = 23) and PACs (n = 8). The mean procedural time was 155.3 ± 46.6 min, with a mean radiation dose of 92.0 (IQR 37.0-121.0) mGy. Total radiofrequency application duration 504.0 (271.0-906.0) s. Left atrial localization of ATs and PACs was identified in 45.1% of the cases, right atrium localization in 45.1%, and septal origins in 9.8% of the cases. Acute success was achieved in 30/31 (96.8%), and recurrence during the follow-up developed in six patients (19.4%), including four patients with PACs and two patients with short-lived ATs. One patient presented procedure-related groin hematoma as minor complication. CONCLUSION: Brief episodes of highly symptomatic ATs and infrequent PACs can be mapped using charge density mapping and successfully ablated with high acute and long-term success rates.

A quality improvement initiative for patient knowledge comprehension during the discharge procedure using a novel computer-generated patient-tailored discharge document in cardiology.

Objective: The duration of hospital admissions has shortened significantly. This challenges healthcare professionals to provide the necessary information and instructions in a limited time. Patient-tailored discharge information may improve the patient's understanding of the discharge information but may also be time-consuming. The objective of this descriptive quality improvement study was to evaluate patient comprehension of discharge information using a novel computer-generated patient-tailored discharge document. Methods: A prospective pre-post study comparing patient-tailored discharge information with conventional discharge information, for patients undergoing an electrophysiological procedure during two periods of six weeks between January and March 2016.Group I received conventional discharge information (n = 55). Group II received a computer-generated, patient-tailored discharge document (n = 57). Their comprehension of the discharge information was evaluated using a peer-reviewed questionnaire distributed among patients, comparing groups I and II using Likert scales. Nurses and nurse practitioners evaluated the use of personalized discharge information by means of a short survey. Results: In terms of discharge information, comprehensibility was equivalent; however, an increase in comprehension was observed in patients seeking a telephone consultation with the cardiology department within one-week post-discharge. A reduction in discharge preparation time and an increased uniformity of discharge information were reported by nurses. Nurse practitioners found the web tool easy to use and time-saving. Conclusions: In this study, computer-generated patient-tailored discharge information was equivalent to conventional discharge information. A more positive trend was seen for patients who initiated teleconsultation with the hospital within one-week post-discharge. This suggests that for this subgroup the patient-tailored discharge web tool might lead to an improvement in care. However, more research with a larger number of participants is needed to confirm this trend.

Left atrial anatomical variations correlate with atrial fibrillation sources near the left atrial ridge.

Introduction: Anatomical variations and characteristics of the left atrium (LA) may have a previously undescribed effect on source locations in atrial fibrillation (AF). This is the first study aiming to investigate the relationship between anatomical characteristics of the LA and non-PV sources detected by electrographic flow (EGF) mapping in patients with persistent AF. Materials and methods: We analyzed cardiac computed tomography (CT) and EGF mapping data in patients who underwent radiofrequency catheter ablation (CA). EGF mapping is a novel method based on Horn-Schunk flow estimation algorithm, used to estimate cardiac action potential flow in the atria that can detect AF sources in patients with persistent AF. By analyzing EGF maps obtained during CA procedures, we localized non-PV sources in the LA. Results: Thirty patients were included in this study (mean age 62.4 ± 6.8 years). Ten patients had AF sources near the LA ridge, while twenty patients had no leading source (source activity > 26%) near the LA ridge. LA anatomical characteristics, left atrial appendage (LAA) length, and ostial diameter showed no correlation with the presence of a leading source. We documented 19 patients with abutting LAA and left superior pulmonary vein (LSPV) (distance < 2 mm), and 11 patients with non-abutting LAA-LSPV (distance > 2 mm). Three out of 19 patients presented with a leading source near ridge in the abutting LAA-LSPV group, while 7 out of 11 patients presented with a leading source near the ridge in the non-abutting LAA-LSPV group (p = 0.01). Conclusion: Our data suggests that non-abutting LAA-LSPV is associated with the presence of AF sources near the LA ridge.

Comparison of the acute outcome of two cryoballoon technologies for pulmonary vein isolation: An updated systematic review and meta-analysis.

Initial experience suggests that the POLARx cryoballoon system (Boston Scientific) has a similar procedural efficacy and safety as Arctic Front Advance Pro (AFA-Pro, Medtronic). We performed an updated systematic review and meta-analysis comparing POLARx and AFA-Pro. Embase, MEDLINE, Web of Science, Cochrane, and Google Scholar databases were searched until 12/01/2022 for studies comparing POLARx versus AFA-Pro in patients undergoing pulmonary vein (PV) isolation for AF. A total of 8 studies, involving 1146 patients from 11 European centers were included (POLARx n = 317; AFA-Pro n = 819). There were no differences in acute PV isolation, procedure time, fluoroscopy time, ablation time, minimal esophageal temperature, and risk of phrenic nerve palsy or thromboembolic events. Balloon nadir temperatures were lower for POLARx in all PVs. Compared with AFA-Pro, POLARx had a higher rate of first freeze isolation in the left inferior PV (LIPV) (odds ratio [OR]: 2.60; 95 % confidence interval [CI]: 1.06 to 6.43; P = 0.04), higher likelihood of time-to-isolation (TTI) recording in LIPV (OR: 2.91; 95 % CI: 1.54 to 5.49; P = 0.001) and right inferior PV (OR: 3.23; 95 % CI: 1.35 to 7.74; P = 0.008). In contrast, the TTI in LIPV was longer with POLARx in comparison to AFA-Pro (mean difference: 7.61 sec; 95 % CI 2.43 to 12.8 sec; P = 0.004). In conclusion, POLARx and AFA-Pro have a similar acute outcome. Interestingly, there was a higher rate of TTI recording in the inferior PVs with POLARx. This updated meta-analysis provides new safety data on esophageal temperature and thromboembolic events.

Dipole charge density mapping integrated in remote magnetic navigation: First-in-human feasibility study.

Aims: Robotic magnetic navigation (RMN) provides increased catheter precision and stability. Formerly, only the CARTO 3 mapping system was integrated with the RMN system (CARTO-RMN). Recently, a novel high-resolution non-contact mapping system (AcQMap) has been integrated with the RMN system (AcQMap-RMN) for the treatment of atrial fibrillation (AF) and atrial tachycardias (AT). We aim to compare the safety, efficiency, and efficacy of AcQMap-RMN with CARTO-RMN guided catheter ablation (CA) procedures. Material and methods: In this prospective registry, procedural safety efficiency and outcome data from total of 238 consecutive patients (147 AcQMap-RMN and 91 CARTO-RMN patients) were compared. Results: AcQMap-RMN is non-inferior in the primary endpoint of safety as compared to CARTO-RMN across the whole group (overall procedural complications in 5 (3.4%) vs. 3 (3.3%) patients, p = 1.0). Overall procedure durations were longer and associated with more fluoroscopy use with AcQMap-RMN (172.5 vs. 129.6 min, p < 0.01; 181.0 vs. 131.0 mGy, p = 0.02, respectively). Procedure duration and fluoroscopy use decreased significantly between the first 30 and the last 30 AcQMap-RMN procedures. The AcQMap-RMN system had fewer recurrences after persistent AF ablations and was non-inferior in paroxysmal AF patients compared to CARTO-RMN at 12 months (36.6% vs. 75.0%, p = 0.04, PAF 6.6% vs. 12.5%, p = 0.58; respectively). CA of AT outcomes were better using the AcQMap-RMN system (1 year recurrence 17.1% vs. 38.7%, p < 0.05). Conclusion: AcQMap-RMN integration has no negative impact on the excellent safety profile of RMN guided ablations. It improves outcomes of CA procedures for persAF and AT but requires longer procedure times and higher fluoroscopy use during the initial learning phase.

Use of a novel integrated dilator-needle system in cryoballoon procedures: a zero-exchange approach.

BACKGROUND: Recently, a novel integrated dilator-needle system (AcQCross Qx, Acutus Medical) was introduced to reduce the number of exchanges for a transseptal access. This system can be used in combination with large bore sheaths. In this pilot study, we evaluated the safety and efficacy of a zero-exchange approach with the AcQCross system in cryoballoon procedures. METHODS: In this retrospective single-center study, we included 40 patients (AcQCross: n = 20; control group: n = 20) who underwent a cryoballoon procedure for the treatment of atrial fibrillation. In the AcQCross and control group, patients underwent ablation with POLARx (Boston Scientific) and Arctic Front Advance Pro (AFA-Pro, Medtronic) in equal numbers (n = 10). In the AcQCross group, the AcQGuide Max sheath (Acutus Medical) was used in all POLARx cases. RESULTS: The baseline characteristics of the study population were comparable between groups. In the AcQCross group, there was a reduction in procedure time (49.7 ± 9.0 min vs. 59.6 ± 8.1 min, P < 0.001) and time from puncture until balloon delivery (15.5 ± 6.8 min vs. 21.5 ± 7.4 min, P = 0.01) in comparison with the control group. The balloon in body time, fluoroscopy time, number of cryoapplications, and biophysical parameters were similar between groups. There was one temporary phrenic nerve injury in the AcQCross group. Importantly, no signs of air embolism were noted with the AcQGuide Max sheath. CONCLUSIONS: The use of the novel AcQCross system improves procedural efficacy in cryoballoon procedures by reducing the number of exchanges.

Impact of undiagnosed obstructive sleep apnea on atrial fibrillation recurrence following catheter ablation (OSA-AF study).

Background: Sleep-disordered breathing (SDB) may hamper the outcome of catheter ablation of atrial fibrillation (AF). However, SDB is underdiagnosed in clinical practice and the relevancy of undiagnosed SDB on the outcome of catheter ablation is unclear. Objective: To evaluate if undiagnosed SDB has an impact on AF recurrence after catheter ablation. Methods: In this single-center cohort study we enrolled patients who had a catheter ablation of AF 12 to 18 months prior to enrolment. Patients with diagnosed SDB at the time of catheter ablation were excluded. Enrolled patients underwent screening using WatchPAT (WP). SDB was defined as an apnea-hypopnea index (AHI) ≥ 15. Results: A total of 164 patients were screened for eligibility. After exclusion of patients with previously diagnosed SDB (n = 30), 104 of 134 eligible patients were enrolled and underwent SDB screening. The median AHI was 11.5 (interquartile range 6.8-21.9) and 39 patients (38%) had SDB which was undiagnosed during the first year after ablation. AF recurrence in the first year after catheter ablation occurred in 40 patients (38%). The risk of AF recurrence was higher in the group with undiagnosed SDB in comparison to those without SDB (51% versus 31%, P = 0.04). Interestingly, the prevalence of AF recurrence was similar between patients with previously diagnosed and undiagnosed SDB (51% versus 50%, P = 0.92). Conclusion: A significant proportion of patients undergoing catheter ablation of AF have undiagnosed SDB which is associated with a twofold higher risk of AF recurrence. SDB screening may improve patient counselling regarding the efficacy of catheter ablation.

Performance and Robustness Testing of a Non-Invasive Mapping System for Ventricular Arrhythmias.

Background: The clinical value of non-invasive mapping system depends on its accuracy under common variations of the inputs. The View Into Ventricular Onset (VIVO) system matches simulated QRS complexes of a patient-specific anatomical model with a 12-lead ECG to estimate the origin of ventricular arrhythmias. We aim to test the performance of the VIVO system and its sensitivity to changes in the anatomical model, time marker placement to demarcate the QRS complex and body position. Methods: Non-invasive activation maps of idiopathic premature ventricular complexes (PVCs) using a patient-specific or generic anatomical model were matched with the location during electrophysiological studies. Activation maps were analyzed before and after systematically changing the time marker placement. Morphologically identical PVCs recorded in supine and sitting position were compared in a subgroup. Results: Non-invasive activation maps of 48 patients (age 51 ± 14 years, 28 female) were analyzed. The origin of the PVCs as determined by VIVO system matched with the clinical localization in 36/48 (75%) patients. Mismatches were more common for PVCs of left than right ventricular origin [11/27 (41%) vs. 1/21 (5%) of cases, p < 0.01]. The first 32 cases were analyzed for robustness testing of the VIVO system. Changing the patient-specific vs. the generic anatomical model reduced the accuracy from 23/32 (72%) to 15/32 (47%), p < 0.05. Time marker placement in the QRS complex (delayed onset or advanced end marker) or in the ST-segment (delaying the QRS complex end marker) resulted in progressive shifts in origins of PVCs. Altered body positions did not change the predicted origin of PVCs in most patients [clinically unchanged 11/15 (73%)]. Conclusion: VIVO activation mapping is sensitive to changes in the anatomical model and time marker placement but less to altered body position.

Accuracy of atrial fibrillation detection by an insertable cardiac monitor in patients undergoing catheter ablation: Results of the BioVAD study.

BACKGROUND: Insertable cardiac monitors (ICMs) are increasingly used to evaluate the atrial fibrillation (AF) burden after catheter ablation of AF. BioMonitor III (BM3) is an ICM with a long sensing vector, which enhances sensing capabilities. The AF detection algorithm of the BM3 is based on R-R interval variability. OBJECTIVE: To evaluate the performance of the AF detection algorithm of BM3 in patients before and after catheter ablation of AF using simultaneous Holter recordings. METHODS: In this prospective study, we enrolled patients scheduled for catheter ablation of paroxysmal or persistent AF. After BM3 implantation, patients had a 4 days Holter registration before and 3 months after ablation. All true AF episodes ≥2 min on the Holter were annotated and matched with BM3 detected AF detections. RESULTS: Thirty-one patients were enrolled (mean age 60 ± 8, 74% male, 68% paroxysmal AF). Fifty-six Holter registrations were performed in 30 patients. Twelve patients demonstrated at least one true AF episode with a total AF duration of 570 h. The AF burden accuracy of BM3 before catheter ablation was 99.6%, with a duration sensitivity of 98.6% and a duration specificity of 99.9%. The AF burden accuracy of BM3 after catheter ablation was 99.8%, with a duration sensitivity of 90.2% and a duration specificity of 99.9%. Overall, the AF burden detected on the Holter and BM3 demonstrated a high Pearson correlation coefficient of 0.996. CONCLUSION: BM3 accurately detects AF burden in patients before and after catheter ablation of AF.

Novel cryoballoon to isolate pulmonary veins in patients with paroxysmal atrial fibrillation: long-term outcomes in a multicentre clinical study.

BACKGROUND: Recently, a novel cryoballoon ablation catheter has demonstrated acute safety and efficacy in de novo pulmonary vein isolation (PVI) procedures in patients with paroxysmal atrial fibrillation (PAF). However, there are limited studies demonstrating the long-term efficacy. The aim of this study was to evaluate the long-term safety and efficacy of this novel cryoballoon in treating PAF. METHODS: This was a non-randomized, prospective, multicentre study enrolling 58 consecutive patients. Cryoablation was delivered for 180 s if time to isolation was ≤ 60 s. Otherwise a 240-s cryoablation was performed. One centre performed pre- and post-ablation high-density mapping (n = 9) to characterize lesion formation. After a 3-month blanking period, recurrence was defined as having any documented, symptomatic episode(s) of AF or atrial tachycardia. All patients were followed for 1 year. RESULTS: Acute PVI was achieved in 230 of 231 pulmonary veins (99.6%) with 5.3 ± 1.6 cryoablations per patient (1.3 ± 0.7 cryoablations per vein). Forty-three (77%) patients remained arrhythmia-free at 1-year follow-up. Four patients (6.9%) experienced phrenic nerve injury (3 resolved during the index procedure; 1 resolved at 6 months). One serious adverse device event was reported: femoral arterial embolism event occurring 2 weeks post-index procedure. For patients who underwent high-density mapping, cryoablation was antral with 50% of the posterior wall ablated. CONCLUSIONS: Initial multicentre clinical experience with a novel cryoballoon has demonstrated safety and efficacy of PVI in patients with PAF. Ablation with this cryoballoon provides a wide, antral lesion set with significant debulking of the posterior wall of the left atrium.