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.

Persistent phrenic nerve palsy after atrial fibrillation ablation: Follow-up data from The Netherlands Heart Registration.

BACKGROUND: Persistent phrenic nerve palsy (PNP) is an established complication of atrial fibrillation (AF) ablation, especially during cryoballoon and thoracoscopic ablation. Data on persistent PNP reversibility is limited because most patients recover <24 h. This study aims to investigate persistent PNP recovery, freedom of PNP-related symptoms after AF ablation and identify baseline variables associated with the occurrence and early PNP recovery in a large nationwide registry study. METHODS: In this study, we used data from the Netherlands Heart Registration, comprising data from 9549 catheter and thoracoscopic AF ablations performed in 2016 and 2017. PNP data was available of 7433 procedures, and additional follow-up data were collected for patients who developed persistent PNP. RESULTS: Overall, the mean age was 62 ± 10 years, and 67.7% were male. Fifty-four (0.7%) patients developed persistent PNP and follow-up was available in 44 (81.5%) patients. PNP incidence was 0.07%, 0.29%, 1.41%, and 1.25%, respectively for patients treated with conventional-RF, phased-RF, cryoballoon, and thoracoscopic ablation respectively. Seventy-one percent of the patients fully recovered, and 86% were free of PNP-related symptoms after a median follow-up of 203 (113-351) and 184 (82-359) days, respectively. Female sex, cryoballoon, and thoracoscopic ablation were associated with a higher risk to develop PNP. Patients with PNP recovering ≤180 days had a larger left atrium volume index than those with late or no recovery. CONCLUSION: After AF ablation, persistent PNP recovers in the majority of patients, and most are free of symptoms. Female patients and patients treated with cryoballoon or thoracoscopic ablation are more prone to develop PNP.

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.

Comparison of procedural efficacy, balloon nadir temperature, and incidence of phrenic nerve palsy between two cryoballoon technologies for pulmonary vein isolation: A systematic review and meta-analysis.

INTRODUCTION: In May 2020, a novel cryoballoon system (POLARx; Boston Scientific) became available for catheter ablation of atrial fibrillation (AF). The design of the cryoballoon is comparable to the Arctic Front Advance Pro (AFA-Pro; Medtronic), but it is more compliant during freezing. We compared the procedural efficacy, biophysical parameters, and risk of phrenic nerve palsy (PNP) between the two cryoballoons. METHODS: Embase, MEDLINE, Web of Science, Cochrane, and Google Scholar databases were searched until June 1, 2021 for relevant studies comparing POLARx versus AFA-Pro in patients undergoing pulmonary vein isolation (PVI) for AF. RESULTS: A total of four studies, involving 310 patients were included. There was no difference between the two groups for outcomes regarding procedural efficacy: acute PVI (odds ratio [OR]: 0.43; 95% confidence interval [CI]: 0.06 to 3.03; p = .40), procedure time (mean difference [MD]: 8.15 min; 95% CI: -8.09 to 24.39; p = .33), fluoroscopy time (MD: 1.32 min; 95% CI: -1.61 to 4.25; p = .38) and ablation time (MD: 1.00 min; 95% CI: -0.20 to 2.20; p = .10). The balloon nadir temperature was lower for all individual pulmonary veins (PV) in POLARx compared with AFA-Pro (MD: -9.74°C, -9.98°C, -6.72°C, -7.76°C, for left superior PV, left inferior PV, right superior PV, and right inferior PV, respectively; all p < .001). The incidence of PNP was similar between groups (OR: 0.79; 95% CI: 0.22 to 2.85; p = .72). CONCLUSION: In AF patients undergoing PVI, POLARx and AFA-Pro had a similar procedural efficacy. Balloon nadir temperatures were lower with POLARx, however, the incidence of PNP was similar.

Comparison of procedural efficacy and biophysical parameters between two competing cryoballoon technologies for pulmonary vein isolation: Insights from an initial multicenter experience.

INTRODUCTION: Recently a novel cryoballoon system (POLARx, Boston Scientific) became available for the treatment of atrial fibrillation. This cryoballoon is comparable with Arctic Front Advance Pro (AFA-Pro, Medtronic), however, it maintains a constant balloon pressure. We compared the procedural efficacy and biophysical characteristics of both systems. METHODS: One hundred and ten consecutive patients who underwent first-time cryoballoon ablation (POLARx: n = 57; AFA-Pro: n = 53) were included in this prospective cohort study. RESULTS: Acute isolation was achieved in 99.8% of all pulmonary veins (POLARx: 99.5% vs. AFA-Pro: 100%, p = 1.00). Total procedure time (81 vs. 67 min, p < .001) and balloon in body time (51 vs. 35 min, p < .001) were longer with POLARx. After a learning curve, these times were similar. Cryoablation with POLARx was associated with shorter time to balloon temperature -30°C (27 vs. 31 s, p < .001) and -40°C (32 vs. 54 s, p < .001), lower balloon nadir temperature (-55°C vs. -47°C, p < .001), and longer thawing time till 0°C (16 vs. 9 s, p < .001). There were no differences in time-to-isolation (TTI; POLARx: 45 s vs. AFA-Pro 43 s, p = .441), however, POLARx was associated with a lower balloon temperature at TTI (-46°C vs. -37°C, p < .001). Factors associated with acute isolation differed between groups. The incidence of phrenic nerve palsy was comparable (POLARx: 3.5% vs. AFA-Pro: 3.7%). CONCLUSION: The novel cryoballoon is comparable to AFA-Pro and requires only a short learning curve to get used to the slightly different handling. It was associated with faster cooling rates and lower balloon temperatures but TTI was similar to AFA-Pro.

Functional electrographic flow patterns in patients with persistent atrial fibrillation predict outcome of catheter ablation.

AIMS: Electrographic flow (EGF) mapping is a method to detect action potential sources within the atria. In a double-blinded retrospective study we evaluated whether sources detected by EGF are related to procedural outcome. METHODS: EGF maps were retrospectively generated using the Ablamap® software from unipolar data recorded with a 64-pole basket catheter from patients who previously underwent focal impulse and rotor modulation-guided ablation. We analyzed patient outcomes based on source activity (SAC) and variability. Freedom from atrial fibrillation (AF) was defined as no recurrence of AF, atypical flutter or atrial tachycardia at the follow-up visits. RESULTS: EGF maps were from 123 atria in 64 patients with persistent or long-standing persistent AF. Procedural outcome correlation with SAC peaked at >26%. S-type EGF signature (source-dependent AF) is characterized by stable sources with SAC > 26% and C-type (source-independent AF) is characterized by sources with SAC ≤ 26%. Cases with AF recurrence at 3-, 6-, or 12-month follow-up showed a median final SAC 34%; while AF-free patients had sources with significantly lower median final SAC 21% (p = .0006). Patients with final SAC and Variability above both thresholds had 94% recurrence, while recurrence was only 36% for patients with leading source SAC and variability below threshold (p = .0001). S-type EGF signature post-ablation was associated with an AF recurrence rate 88.5% versus 38.1% with C-type EGF signature. CONCLUSIONS: EGF mapping enables the visualization of active AF sources. Sources with SAC > 26% appear relevant and their presence post-ablation correlates with high rates of AF recurrence.

Complications in pulmonary vein isolation in the Netherlands Heart Registration differ with sex and ablation technique.

AIMS: Pulmonary vein isolation (PVI) has become a cornerstone of the invasive treatment of atrial fibrillation. Severe complications are reported in 1-3% of patients. This study aims to compare complications and follow-up outcome of PVI in patients with atrial fibrillation. METHODS AND RESULTS: The data were extracted from the Netherlands Heart Registration. Procedural and follow-up outcomes in patients treated with conventional radiofrequency (C-RF), multielectrode phased RF (Ph-RF), or cryoballoon (CB) ablation from 2012 to 2017 were compared. Subgroup analysis was performed to identify variables associated with complications and repeat ablations. In total, 13 823 patients (69% male) were included. The reported complication incidence was 3.6%. Patients treated with C-RF developed more cardiac tamponades (C-RF 0.8% vs. Ph-RF 0.3% vs. CB 0.3%, P ≤ 0.001) and vascular complications (C-RF 1.7% vs. Ph-RF 1.2% vs. CB 1.3%, P ≤ 0.001). Ph-RF was associated with fewer bleeding complications (C-RF: 1.0% vs. Ph-RF: 0.4% vs. CB: 0.7%, P = 0.020). Phrenic nerve palsy mainly occurred in patients treated with CB (C-RF: 0.1% vs. Ph-RF: 0.2% vs. CB: 1.5%, P ≤ 0.001). In total, 18.4% of patients were referred for repeat ablation within 1 year. Female sex, age, and CHA2DS2-VASc were independent risk factors for cardiac tamponade and bleeding complications, with an adjusted OR for female patients of 2.97 (95% CI 1.98-4.45) and 2.02 (95% CI 1.03-4.00) respectively. CONCLUSION: The reported complication rate during PVI was low. Patients treated with C-RF ablation were more likely to develop cardiac tamponades and vascular complications. Female sex was associated with more cardiac tamponade and bleeding complications.

Advance care planning and end-of-life care in patients with an implantable cardioverter defibrillator: The perspective of relatives.

BACKGROUND: Little is known about the last phase of life of patients with implantable cardioverter defibrillators and the practice of advance care planning in this population. AIM: To describe the last phase of life and advance care planning process of patients with an implantable cardioverter defibrillator, and to assess relatives' satisfaction with treatment and care. DESIGN: Mixed-methods study, including a survey and focus group study. SETTING/PARTICIPANTS: A survey among 170 relatives (response rate 59%) reporting about 154 deceased patients, and 5 subsequent focus groups with 23 relatives. RESULTS: Relatives reported that 38% of patients had a conversation with a healthcare professional about implantable cardioverter defibrillator deactivation. Patients' and relatives' lack of knowledge about device functioning and the perceived lack of time of healthcare professionals were frequently mentioned barriers to advance care planning. Twenty-four percent of patients experienced a shock in the last month of life, which were, according to relatives, distressing for 74% of patients and 73% of relatives. Forty-two to sixty-one percent of relatives reported to be satisfied with different aspects of end-of-life care, such as the way in which wishes of the patient were respected. Quality of death was scored higher for patients with a deactivated device than those with an active device (6.74 vs 5.67 on a 10-point scale, p = 0.012). CONCLUSIONS: Implantable cardioverter defibrillator deactivation was discussed with a minority of patients. Device shocks were reported to be distressing to patients and relatives. Relatives of patients with a deactivated device reported a higher quality of death compared to relatives of patients with an active device.

Extensive scar modification for the treatment of intra-atrial re-entrant tachycardia in patients after congenital heart surgery.

BACKGROUND: Catheter ablation is an important therapeutic option for atrial tachycardias in patients with CHD. As a result of extensive scarring and surgical repair, multiple intra-atrial re-entrant tachycardia circuits develop and serve as a substrate for arrhythmias. The best ablation approach for patients with multiple intra-atrial re-entrant tachycardias has not been investigated. Here, we compared substrate-based ablation using extensive scar modification to conventional ablation. METHODS: The present study included patients with surgically corrected CHD that underwent intra-atrial re-entrant tachycardia ablation. Extensive scar modification was defined as substrate ablation based on a dense voltage map, aimed to eliminate all potentials in the scar region. The control group had activation mapping-based ablation. A clinical composite endpoint was assessed. Points were given for type, number, and treatment of intra-atrial re-entrant tachycardia recurrence. RESULTS: In 40 patients, 63 (extensive scar modification 13) procedures were performed. Acute procedural success was achieved in 78%. Procedural duration was similar in both groups. Forty-nine percent had a recurrence within 1 year. During a 5-year follow-up (2.5-7.5 years), 46% required repeat catheter ablation. Compared to baseline, clinical composite endpoint significantly decreased by 46% after 12 months (p = 0.001). Acute procedural success, procedural parameters, recurrence and repeat ablation were similar between extensive scar modification and activation mapping-based ablation. CONCLUSION: Catheter ablation using extensive scar modification for intra-atrial re-entrant tachycardias occurring after surgically corrected CHD illustrated similar short- and long-term outcomes and procedural efficiency compared to catheter ablation using activation mapping-based ablation. The choice of ablation approach for multiple intra-atrial re-entrant tachycardia should remain at the discretion of the operator.

Type and rate of atrial fibrillation termination due to rotational activity ablation combined with pulmonary vein isolation.

BACKGROUND: There remains controversy about the optimal ablation technique and termination rate of atrial fibrillation (AF) during catheter ablation in patients with persistent AF. The aim of this study was to determine the rate and timing of AF termination during combined pulmonary vein isolation (PVI) and focal impulse and rotor modulation (FIRM)-guided ablation of rotational activity (RoAc). METHODS: This single-center, prospective cohort study enrolled 38 consecutive patients (63% male, mean age 63 ± 11 years) with persistent AF (mean left atrial size: 46 ± 7 mm), who underwent FIRM mapping and ablation of the identified RoAcs followed by PVI. We systematically evaluated the incidence and timing of AF termination during AF ablation. RESULTS: "Late-onset termination" of AF could be observed in 12 (32%) patients after ablation of the identified RoAcs. In a further 10 (26%) patients, "abrupt" AF termination during PVI was achieved. In total, the combined technique of conventional PVI and RoAc ablation resulted in AF termination rate of 58%. ECV was performed in 16 "nonterminating" patients. At 1-year follow-up, 76.1% (16 of 21) of patients remained free from AF/AT, 4 of 10 patients (25%) within the "abruptly" terminated group, 7 of 12 (58.3%) patients among the "late-terminated" group, and 5 of 16 (31, 25%) patients in the "nonterminating" group. CONCLUSION: Large area RoAc ablation combined with PVI results in a moderate termination rate of persistent AF with two distinctive timing patterns. More studies are needed to determine the clinical significance of type of AF termination and long-term success rate of RoAc ablation in patients with persistent AF.

Safety and Clinical Outcome of Catheter Ablation of Ventricular Arrhythmias Using Contact Force Sensing: Consecutive Case Series.

BACKGROUND: Poor catheter-to-myocardial contact can lead to ineffective ablation lesions and suboptimal outcome. Contact force (CF) sensing catheters in ventricular tachyarrhythmia (VT) ablations have not been studied for their long-term efficacy. PURPOSE: The aim of this study was to compare CF ablation to manual ablation (MAN) and remote magnetic navigation (RMN) ablation for safety and efficacy in acute and long-term outcome. METHODS: A total of 239 consecutive patients who underwent VT ablation with the use of MAN, CF, or RMN catheters were included in this single-center cohort study from January 2007 until March 2014. The primary endpoints were procedural success, acute major complications, and VT recurrences at follow-up. The median follow-up period was 25 months. RESULTS: Acute success was achieved in 182 out of 239 procedures (76%). Acute success in manual ablation, CF ablation and RMN ablation was 71%, 71%, and 86%, respectively (P = 0.03). Major complications occurred in 3.3% and there were less major complications (P = 0.04) in the RMN group. After an initial successful procedure, 66 of 182 patients (36%) had a recurrence during follow-up. This was not significantly different between groups. Using an intention-to-treat analysis, 124 patients (52%) had a recurrence. The recurrence rate was lowest in the RMN group. CONCLUSION: The use of CF sensing catheters did not improve procedural outcome or safety profile in comparison to non-CF sensing ablation in this observational study of ventricular arrhythmia ablations.

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.

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).

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.

Regular atrial tachycardias developing after cryoballoon pulmonary vein isolation: incidence, characteristics, and predictors.

AIMS: Cryoballoon ablation (CBA) is a well-used technique when performing pulmonary vein (PV) isolation in patients with paroxysmal atrial fibrillation (AF). Our aim is to describe incidence, characteristics, and clinical predictors for developing atrial tachycardias (ATs) after cryoballoon PV isolation in patients with paroxysmal AF. METHODS AND RESULTS: The study population consisted of 181 consecutive patients undergoing a first CBA. All patients received an event-recorder before cryoablation and transmitted daily electrocardiogram (ECG) during 1 month before ablation and 3 months after. Further follow-up consisted of 24 h Holter monitoring and ECG registration every 3 months and also in patients presenting with symptoms. A mean follow-up period was 497.9 ± 283.9 days, and 175 patients completed follow-up. In 14 (8%) patients regular ATs were registered. In multivariate logistic regression model, the following parameters were independently associated with ATs after ablation: an additional right PV, treatment with beta-blockers, and presence of AT on event-recording strips before ablation. Seven (4%) patients with registered AT underwent a redo procedure. In two (1.1%) patients ATs were originated in reconnected PVs. In other patients no left AT was induced. No macro re-entrant left AT was documented in any patient. During follow-up, after a redo ablation, no AT was registered. CONCLUSION: The incidence of left AT after CBA is low, and no left atrial macro re-entrant tachycardia was found. The following independent predictors of AT development have been identified: an additional right PV, regular AT registered before ablation, and the use of beta-blockers.

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.

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.

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.