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.
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.
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.
Introduction
Pulmonary vein isolation (PVI) is well established as a primary treatment for atrial fibrillation (AF). The POLAR ICE study was designed to collect prospective real world data on the ...safety and effectiveness of the POLARxTM cryoballoon for PVI to treat paroxysmal AF.
Methods
POLAR ICE, a prospective, non‐randomized, multicenter (international) registry (NCT04250714), enrolled 399 patients across 19 European centers. Procedural characteristics, such as time to isolation, cryoablations per pulmonary vein (PV), balloon nadir temperature, and occlusion grade were recorded. PVI was confirmed with entrance block testing.
Results
Data on 372 de novo PVI procedures (n = 2190 ablations) were collected. Complete PVI was achieved in 96.8% of PVs. Procedure and fluoroscopy times were 68.2 ± 24.6 and 15.6 ± 9.6 min, respectively. Left atrial dwell time was 46.6 ± 18.3 min. Grade 3 or 4 occlusion was achieved in 98.2% of PVs reported and 71.2% of PVs isolation required only a single cryoablation. Of 2190 cryoapplications, 83% had a duration of at least 120 s; nadir temperature of these ablations averaged −56.3 ± 6.5°C. There were 6 phrenic nerve palsy events, 2 of which resolved within 3 months of the procedure.
Conclusion
This real‐world usage data on a novel cryoballoon suggests this device is effective, safe, and relatively fast in centers with cryoballoon experience. These data are comparable to prior POLARx reports and in keeping with reported data on other cryoballoons. Future studies should examine the long‐term outcomes and the relationship between biophysical parameters and outcomes for this novel cryoballoon.
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.
This prospective study investigated ablative therapy techniques as a treatment of paroxysmal atrial fibrillation (AF). This figure presents a schematical overview of the study population and distribution among treatment groups. After 12 months of follow‐up, there was an 81% freedom of AF in general, which was significantly higher in patients treated with robotic magnetic navigation‐guided radiofrequency ablation (RMN‐RF).
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.
Introduction
Experience with the subcutaneous implantable cardioverter‐defibrillator (S‐ICD) is expanding rapidly. However, data on long‐term performance or complications related to elective ...generator replacement are lacking.
Methods
Follow‐up (FU) data of all patients implanted between December 2008 and April 2011 were collected. Complications were defined as those requiring surgical intervention. Kaplan‐Meier estimates for complication and shock rates, with corresponding 95% confidence intervals (CI), were calculated.
Results
One hundred and eighteen patients were included. Median FU was 6.1 years (IQR 5.6–6.5 years). Short‐term complication rate (0–30 days) was 3% (CI 0–6%). Long‐term complication rate at 6 years was 19% (CI 12–26%), corresponding with an annual complication rate of 3%. One patient in this cohort developed a need for a transvenous ICD (TV‐ICD) in order to provide pacing for bradycardia (1%). Six patients were implanted with a TV‐ICD after experiencing an S‐ICD complication for which extraction was necessary. In total, 10 S‐ICDs were extracted; none resulted in a complication. Eight patients had a nonsystemic ICD‐related infection and no lead failures were observed. The majority, 68 (58%) patients, received an elective generator replacement. Two patients had a complication related to generator replacement (3%). Battery longevity was 5.6 years (IQR 5.2–6.1). Appropriate and inappropriate shock rates of 6‐year estimates were 17% (CI 9–25%) and 21% (CI 15–27%), respectively.
Conclusions
This cohort represents the longest follow‐up to date and shows a low annual complication rate without lead failures or systemic infections. Battery longevity of the first S‐ICD generation results in relative early generator replacement procedures.
Introduction
Cardiac resynchronization defibrillator (CRT‐D) as primary prevention is known to reduce mortality. At the time of replacement, higher age and comorbidities may attenuate the benefit of ...implantable cardioverter‐defibrillator (ICD) therapy. The purpose of this study was to evaluate the progression of comorbidities after implantation and their association with mortality following CRT‐D generator replacement. In addition, a risk score was developed to identify patients at high risk for mortality after replacement.
Methods and Results
We identified patients implanted with a primary prevention CRT‐D (n = 648) who subsequently underwent elective generator replacement (n = 218) from two prospective ICD registries. The cohort consisted of 218 patients (median age: 70 years, male gender: 73%, mean left ventricular ejection fraction LVEF: 36 ± 11% at replacement). Median follow‐up after the replacement was 4.2 years during which 64 patients (29%) died and 11 patients (5%) received appropriate ICD shocks. An increase in comorbidities was observed in 77 patients (35%). The 5‐year mortality rate was 41% in patients with ≥2 comorbidities at the time of replacement. A risk score incorporating age, gender, LVEF, atrial fibrillation, anemia, chronic kidney disease, and history of appropriate ICD shocks at time of replacement accurately predicted 5‐year mortality (C‐statistic 0.829). Patients with a risk score of greater than 2.5 had excess mortality at 5‐year postreplacement compared with patients with a risk score less than 1.5 (57% vs. 6%; p < .001).
Conclusion
A simple risk score accurately predicts 5‐year mortality after replacement in CRT‐D patients, as patients with a risk score of greater than 2.5 are at high risk of dying despite ICD protection.
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.
PDF
