The impact of hyperbaric oxygen treatment for cardiovascular implantable electronic devices.

Introduction: The safety of hyperbaric oxygen treatment (HBO2) in patients with cardiovascular implanted electronic devices (CIED) remains unclear. Methods: We conducted a retrospective analysis of seven CIED patients (median age 79 [73-83] years, five males [71.4%]), including five with pacemakers and two with implantable cardioverter defibrillators (ICD), who underwent HBO2 between June 2013 and April 2023. During the initial session, electrocardiogram monitoring was conducted, and CIED checks were performed before and after the treatment. In addition, the medical records were scrutinized to identify any abnormal CIED operations. Results: All seven CIED patients underwent HBO2 within the safety pressure range specified by the CIED manufacturers or general pressure test by the International Organization for Standardization (2.5 [2.5-2.5] atmosphere absolute × 18 [5-20] sessions). When comparing the CIED parameters before and after HBO2, no significant changes were observed in the waveform amplitudes, pacing thresholds, lead impedance of the atrial and ventricular leads, or battery levels. All seven patients, including two with the rate response function activated, exhibited no significant changes in the pacing rate or pacing failure. Two ICD patients did not deactivate the therapy, including the defibrillation; however, they did not experience any arrhythmia or inappropriate ICD therapy during the HBO2. Conclusion: CIED patients who underwent HBO2 within the safety pressure range exhibited no significant changes in the parameters immediately after the HBO2 and had no observable abnormal CIED operations during the treatment. The safety of defibrillation by an ICD during HBO2 should be clarified.

Distribution of antral lesions with the novel size-adjustable cryoballoon for pulmonary vein isolation and the differences based on left atrial remodeling.

INTRODUCTION: The novel cryoballoon with 28 mm or 31 mm adjustable diameters, aims to achieve a wide antral pulmonary vein isolation (PVI). However, the distribution of antral lesions and their variations based on left atrial (LA) remodeling require further clarification. METHODS: We evaluated 22 patients (67 [59.5-74.8] years, 19 males) who underwent PVI of atrial fibrillation (AF) (13 paroxysmal AF [PAF] and 9 non-PAF) using size-adjustable cryoballoons. LA electro-anatomical mapping was performed post-PVI with three-dimensional mapping systems. We assessed the shapes of the LA and pulmonary veins (PVs) and the distribution of isolated areas (IAs), comparing the results between PAF and non-PAF patients. RESULTS: In the left PVs (LPVs), the distance between the PV orifice and IA edge (PVos-IA) was larger on the roof and posterior segments (~15 mm) but relatively smaller on the anterior segment near the PV ridge (<10 mm). For the right PVs (RPVs), it was more extensive in the posterior segment (10-15 mm). Comparing PAF and non-PAF, there were no significant differences in the PVos-IA except for the right posterior-carina segment, antrum IA (LPVs: 5.9 ± 1.6 vs. 5.8 ± 0.8 cm², p = .81; RPVs: 4.8 ± 2.3 vs. 4.8 ± 1.2 cm², p = .81), distances between the right and left IAs on the LA posterior wall (LAPW), and un-isolated LAPW area (9.0 ± 4.9 vs. 9.9 ± 2.5 cm², p = .62). No individual PVIs were observed in either group. Two patients exhibited overlapping IAs on the roof, and one patient who underwent 31 mm balloon applications for all PVs exhibited an LAPW isolation. CONCLUSION: The size-adjustable cryoballoon achieved a wide antral PVI even in non-PAF patients.

Acute procedural safety of the latest radiofrequency ablation catheters in atrial fibrillation ablation: Data from a large prospective ablation registry.

BACKGROUND: Safety data of the latest radiofrequency (RF) technologies during atrial fibrillation (AF) ablation in real-world clinical practice are limited. OBJECTIVES: We sought to evaluate the acute procedural safety of the four latest ablation catheters commonly used for AF ablation. METHODS: A total of 3957 AF ablation procedures performed between January 2022 and December 2023 at 20 centers with either the THERMOCOOL SMARTTOUCH SF (STSF), TactiCath (TC), QDOT Micro (QDM), or TactiFlex (TF) were retrospectively analyzed. RESULTS: In total, QDM, STSF, TF, and TC were used in 343 (8.7%), 1793 (45.3%), 1121 (28.4%), and 700(17.7%) procedures. Among 2406 index procedures, electrical pulmonary vein isolations were successfully achieved in 99.5%. Despite similar total procedure times in the four groups, the total fluoroscopic time was significantly shorter for QDM/STSF with CARTO than TF/TC with EnSite (18.7 ± 14 vs. 27.6 ± 20.6 min, p < .001) and longest in the TF group. The incidence of cardiac tamponade was 0.7% (0.5% and 0.9% during index and redo procedures, 0.8% and 0.3% for paroxysmal and non-paroxysmal AF) and was significantly lower for QDM/STSF than TF/TC (0.2% vs. 1.1%, p = .008) and highest in the TF group. The incidence of cardiac tamponade was higher for TF than TC and STSF than QDM. In the multivariate analysis, TF/TC with EnSite was a significant independent predictor of cardiac tamponade during both the index (odds ratio [OR] = 4.8, 95% confidence interval [CI] = 1.3-17.5, p = .02) and all procedures (OR = 3.0, 95% CI = 1.3-7.2, p = .01). CONCLUSIONS: The incidence of cardiac tamponade and the fluoroscopic time during AF ablation significantly differed among the latest RF catheters and mapping systems in real-world clinical practice.

Impact of Ethanol Infusion to the Vein of Marshall in Atrial Fibrillation and Atrial Tachycardia.

The ligament of Marshall is an epicardial structure characterized by its composition of fat, fibrous tissue, blood vessels, muscle bundles, nerve fibers, and ganglia. Its intricate network forms muscular connections with the coronary sinus and left atrium, alongside adjacent autonomic nerves and ganglion cells. This complexity plays a pivotal role in initiating focal electrical activities and sustaining micro- and macro-reentrant circuits, thereby contributing to the onset of atrial fibrillation and atrial tachycardia. However, endocardial ablation in this area may encounter challenges due to anatomical variations and insulation by fibrofatty tissue. Combining ethanol infusion into the vein of Marshall with radiofrequency ablation presents a promising strategy for effectively and safely eliminating this arrhythmogenic structure and terminating associated tachycardias.

An optimized approach for increasing lesion size in temperature-controled setting using a catheter with a surface thermocouple and efficient irrigation.

Background: We explore an optimized approach for increasing lesion size using a novel ablation catheter with a surface thermocouple and efficient irrigation in a temperature-control setting. Methods: We conducted radiofrequency applications at various power levels (35 W, 40 W, and 45 W), contact forces (CFs, 10 g/20 g), and durations (60 s/120 s/180 s) in perpendicular/parallel catheter orientations, with normal saline irrigation (NS-irrigation) and Half NS-irrigation (HNS-irrigation) in an ex-vivo model (Step 1). In addition, we performed applications (35 W/40 W/45 W for 60 s/120 s/180 s in NS-irrigation and 35 W/40 W for 60 s/120 s/180 s in HNS-irrigation) in four swine (Step 2), evaluating lesion characteristics and the occurrence of steam pops. Results: In Step 1, out of 288 lesions, we observed 47 (16.3%) steam pops, with 13 in NS-irrigation and 34 in HNS-irrigation (p = .001). Although steam pops were mostly observed with the most aggressive setting (45 W/180 s, 54%) with NS-irrigation, they happened in less aggressive settings with HNS irrigation. Lesion size significantly increased with longer-duration ablation but not with HNS-irrigation. The optimal %impedance-drop cutoff to predict steam pops was 20% with a negative-predictive-value (NPV) = 95.1% including NS- and HNS-irrigation groups, and 22% with an NPV = 96.1% in NS-irrigation group. In Step 2, similar to the ex-vivo model, lesion size significantly increased with longer-duration ablation but not with HNS-irrigation. Steam pops were absent with NS-irrigation (0/35) even with the largest %impedance-drop reaching 31% at 45 W/180 s. All steam pops were observed with HNS-irrigation (6/21, 29%). The optimal %impedance-drop cutoff predicting steam pops was 24% with an NPV = 96.3% including both NS- and HNS-irrigation groups. Conclusions: Rather than using HNS-irrigation, very long-duration of radiofrequency applications up to 45 W/180 s may be recommended to safely and effectively increase lesion dimensions using this catheter with NS-irrigation.

A randomized controlled trial of the size-adjustable cryoballoon vs conventional cryoballoon for paroxysmal atrial fibrillation: The CONTRAST-CRYO II trial rationale and design.

Background: Pulmonary vein isolation (PVI) with cryoballoon technology is a well-established therapy for treatment of atrial fibrillation (AF). Recently, a size-adjustable cryoballoon (POLARxTM FIT) that enables delivery in a standard 28-mm or an expanded 31-mm size was introduced. Objective: The purpose of this study was to perform a randomized clinical trial to evaluate the safety and efficacy of this novel cryoballoon compared to the conventional cryoballoon. Methods: The CONTRAST-CRYO II trial is a multicenter, prospective, open-label, randomized controlled trial in which 214 patients with paroxysmal AF will be randomized 1:1 to cryoballoon ablation with either a conventional cryoballoon (Arctic Front AdvanceTM Pro) or a size-adjustable cryoballoon (POLARx FIT). The study was approved by the Institutional Review Boards at all investigational sites and has been registered in the UMIN Clinical Trials Registry (UMIN000052500). Results: The primary endpoint of this study will be the incidence of phrenic nerve injury. Secondary endpoints include procedural success, chronic success through 12 months, procedure-related adverse events, biophysiological parameters during applications for each pulmonary vein (PV), total procedural and fluoroscopy times, level of PVI and isolation area, and probability of non-PV foci initiating AF. Conclusion: The CONTRAST-CRYO II trial is a multicenter, prospective, randomized controlled trial designed to assess the safety and efficacy of the POLARx FIT vs the Arctic Front Advance Pro. The findings from this trial will provide additional utility data on the efficacy of the size-adjustable cryoballoon for isolating PVs in patients with paroxysmal AF.

Distribution of peak frequency and omnipolar voltage in electrograms across the atrial body and thoracic veins in a normal heart.

BACKGROUND: The innovative peak frequency mapping facilitates the quantification of electrogram sharpness. However, reference values for normal atrial tissue are currently undefined. In this study, we explored the distribution of peak frequency and omnipolar peak-to-peak voltage (V-max) in a normal heart. METHODS: Twenty-two patients with structurally normal heart were included. Either the right atrium (RA) and superior vena cava (SVC) or the left atrium (LA) and pulmonary veins (PVs) were mapped during sinus rhythm. RESULTS: In total, 13,654 points in the RA and 4143 points in the SVC from 15 patients and 4662 points in the LA and 2761 points in PVs from 7 patients were analyzed. The correlation between peak frequency and V-max was weak (R = 0.223). The median peak frequency was larger in the SVC than in the RA (441 [358-524] Hz vs. 358 [291-441] Hz, P < 0.0001) and in PVs than in the LA (346 [253-441] Hz vs. 323 [262-397] Hz, P < 0.0001). Conversely, the median V-max was smaller in the SVC than in the RA (1.96 [0.77-3.75] mV vs. 4.11 [2.10-6.83] mV, P < 0.0001) and in PVs than in the LA (1.16 [0.33-3.17] mV vs. 4.42 [2.63-6.84] mV, P < 0.0001). More than 95% of peak frequencies were > 174 Hz in the RA and > 185 Hz in the LA, and > 95% of V-maxes were > 0.52 and > 1.07 mV in the RA and LA, respectively. CONCLUSION: Given the limited correlation between peak frequency and V-max, and recognizing their potential to provide distinct information, they can be used complementarily. Employing these parameters to extract varied insights can provide comprehensive understandings of tissue characteristics.

Incidence of phrenic nerve injury during pulmonary vein isolation using different cryoballoons: data from a large prospective ablation registry.

AIMS: Phrenic nerve injury (PNI) is the most common complication during cryoballoon ablation. Currently, two cryoballoon systems are available, yet the difference is unclear. We sought to compare the acute procedural efficacy and safety of the two cryoballoons. METHODS: This prospective observational study consisted of 2,555 consecutive atrial fibrillation (AF) patients undergoing pulmonary vein isolation (PVI) using either conventional (Arctic Front Advance) (AFA-CB) or novel cryoballoons (POLARx) (POLARx-CB) at 19 centers between January 2022 and October 2023. RESULTS: Among 2,555 patients (68.8 ± 10.9 years, 1,740 men, paroxysmal AF[PAF] 1,670 patients), PVIs were performed by the AFA-CB and POLARx-CB in 1,358 and 1,197 patients, respectively. Touch-up ablation was required in 299(11.7%) patients. The touch-up rate was significantly lower for POLARx-CB than AFA-CB (9.5% vs. 13.6%, p = 0.002), especially for right inferior PVs (RIPVs). The touch-up rate was significantly lower for PAF than non-PAF (8.8% vs. 17.2%, P < 0.001) and was similar between the two cryoballoons in non-PAF patients. Right PNI occurred in 64(2.5%) patients and 22(0.9%) were symptomatic. It occurred during the right superior PV (RSPV) ablation in 39(1.5%) patients. The incidence was significantly higher for POLARx-CB than AFA-CB (3.8% vs. 1.3%, P < 0.001) as was the incidence of symptomatic PNI (1.7% vs. 0.1%, P < 0.001). The difference was significant during RSPV (2.5% vs. 0.7%, P < 0.001) but not RIPV ablation. The PNI recovered more quickly for the AFA-CB than POLARx-CB. CONCLUSIONS: Our study demonstrated a significantly higher incidence of right PNI and lower touch-up rate for the POLARx-CB than AFA-CB in the real-world clinical practice.

Propensity-score matched comparison of renal and neurohormonal effects of catheter ablation for frequent premature ventricular contractions in patients with and without systolic dysfunction.

Background: Catheter ablation (CA) for premature ventricular contractions (PVCs) restores cardiac and renal functions in patients with reduced left ventricular ejection fraction (LVEF); however, its effects on preserved EF remain unelucidated. Methods: The study cohort comprised 246 patients with a PVC burden of >10% on Holter electrocardiography. Using propensity matching, we compared the changes in B-type natriuretic peptide (BNP) levels and estimated glomerular filtration rate (eGFR) in patients who underwent CA or did not. Results: Postoperative BNP levels were decreased significantly in the CA group, regardless of the degree of LVEF, whereas there was no change in those of the non-CA group. Among patients who underwent CA, BNP levels decreased from 44.1 to 33.0 pg/mL in those with LVEF ≥50% (p = .002) and from 141.0 to 87.9 pg/mL in those with LVEF <50% (p < .001). Regarding eGFR, postoperative eGFR was significantly improved in the CA group of patients with LVEF ≥50% (from 71.4 to 74.7 mL/min/1.73 m2, p = .006), whereas it decreased in the non-CA group. A similar trend was observed in the group with a reduced LVEF. Adjusted for propensity score matching, there was a significant decrease in the BNP level and recovery of eGFR after CA in patients with LVEF >50%. Conclusions: This study showed that CA for frequent PVCs decreases BNP levels and increases eGFR even in patients with preserved LVEF.

Impact of contact force on the lesion characteristics of very high-power short-duration ablation using a QDOT-MICRO catheter.

Background: Lesion size is reported to become larger as contact force (CF) increases. However, this has not been systematically evaluated in temperature-guided very high-power short-duration (vHPSD) ablation, which was therefore the purpose of this study. Methods: Radiofrequency applications (90 W/4 s, temperature-control mode) were performed in excised porcine myocardium with four different CFs of 5, 15, 25, and 35 g using QDOT-MICRO™ catheter. Ten lesions for each combination of settings were created, and lesion metrics and steam-pops were compared. Results: A total of 320 lesions were analyzed. Lesion depth, surface area, and volume were smallest for CF of 5 g than for 15, 25, and 35 g (depth: 2.7 mm vs. 2.9 mm, 3.0 mm, 3.15 mm, p < .01; surface area: 38.4 mm2 vs. 41.8 mm2, 43.3 mm2, 41.5 mm2, p < .05; volume: 98.2 mm3 vs. 133.3 mm3, 129.4 mm3, 126.8 mm3, p < .01 for all pairs of groups compared to CF = 5 g). However, no significant differences were observed between CFs of 15-35 g. Average power was highest for CF of 5 g, followed by 15, 25, and 35 g (83.2 W vs. 82.1 W vs. 77.1 W vs. 66.1 W, p < .01 for all pairs), reflecting the higher incidence of temperature-guided power titration with greater CFs (5 g:8.8% vs. 15 g:52.5% vs. 25 g:77.5% vs. 35 g:91.2%, p < .01 for all pairs except for 25 g vs. 35 g). The incidence of steam-pops did not significantly differ between four groups (5 g:3.8% vs. 15 g:10% vs. 25 g:6.2% vs. 35 g:2.5%, not significant for all pairs). Conclusions: For vHPSD ablation, lesion size does not become large once the CF reaches 15 g, and the risk of steam-pops may be mitigated through power titration even in high CFs.

Epicardial adipose tissue density predicts the presence of atrial fibrillation and its recurrence after catheter ablation: three-dimensional reconstructed image analysis.

Epicardial adipose tissue (EAT) induces inflammation in the atria and is associated with atrial fibrillation (AF). Several studies have examined the relationship between EAT volume (EAT-V) and density (EAT-D) and the presence of AF after catheter ablation. However, conclusions have been inconsistent. This study included 43 consecutive patients who underwent catheter ablation for AF and 30 control patients. EAT-V and EAT-D around the entire heart, entire atrium, left atrium (LA), and right atrium (RA) were measured in detail using reconstructed three-dimensional (3D) EAT images from dual-source computed tomography (CT). None of the measurements of EAT-V differed significantly between patients with AF and controls or between patients with recurrent AF and those without. On the other hand, all measurements of EAT-D were higher in patients with AF than in controls (entire atrium, p < 0.001; RA, p < 0.001; LA, p = 0.002). All EAT-D measurements were associated with the presence of AF. Among patients with AF who underwent ablation, all EAT-D measurements were higher in patients with recurrent AF than in those without. The difference was significant for EATRA-D (p = 0.032). All atrial EAT-D values predicted recurrent AF (EATRA-D: hazard ratio [HR], 1.208; 95% confidence interval [95% CI], 1.053-1.387; p = 0.007; EATLA-D: HR, 1.108; 95% CI 1.001-1.225; p = 0.047; EATatrial-D: HR, 1.174; 95% CI 1.040-1.325; p = 0.010). The most sensitive cutoffs for predicting recurrent AF were highly accurate for EATRA-D (area under the curve [AUC], 0.76; p < 0.01) and EATatrial-D (AUC = 0.75, p < 0.05), while the cutoff for EATLA-D had low accuracy (AUC, 0.65; p = 0.209). For predicting the presence of AF and recurrent AF after catheter ablation, 3D analysis of atrial EAT-D, rather than EAT-V, is useful.

Effect of reference electrode on intracardiac electrograms: Close indifferent electrode vs Wilson central terminal.

BACKGROUND: Unipolar electrograms (uni-EGMs) are an essential part of intracardiac mapping. Although Wilson central terminal (WCT) is conventionally used as a reference for signals, avoidance of contamination by far-field and nonphysiologic signals is challenging. OBJECTIVE: The aim of the study was to explore the impact of an intracardiac indifferent reference electrode close to the recording electrodes, in lieu of WCT, on electrograms. METHODS: Sinus node activation was mapped in patients undergoing catheter ablation by a multielectrode array with a close indifferent electrode (CIE) embedded in the distal end of the catheter shaft. An equal number of points was sequentially acquired at each site with use of CIE as a reference first and subsequently with WCT. Uni-EGMs, bipolar EGMs, and the earliest activation area (defined as the area activated in the first 10 ms of the beat) were compared between CIE- and WCT-based activation maps. RESULTS: Seventeen patients (61 ± 18 years; 76% male) were studied. Uni-EGM voltages acquired with CIE were significantly larger than (n = 11) or comparable to (n = 4) those acquired with WCT. When points from the entire cohort were analyzed altogether, unipolar voltages and their maximum negative dV/dT and bipolar voltages recorded with CIE were significantly larger than those recorded with WCT (2.36 [1.42-3.79] mV vs 1.96 [1.25-3.03] mV, P < .0001; 0.40 [0.18-0.77] mV/s vs 0.35 [0.15-0.71] mV/s, P < .0001; and 1.46 [0.66-2.81] mV vs 1.33 [0.54-2.64] mV, P < .0001, respectively). The earliest activation area was significantly smaller in CIE-based activation maps than in WCT-based ones (0.3 [0.7-1.4] cm2 vs 0.6 [1.0-1.8] cm2, P = .01). CONCLUSION: CIE-based maps were associated with an approximately 20% increase in unipolar voltage and may highlight the origin of a focal activation more clearly than WCT-based ones.

Phrenic nerve injury after atrial fibrillation ablation: different recovery courses among cryoballoon, laser balloon, and radiofrequency ablation.

BACKGROUND: Phrenic nerve injury (PNI) is one of the common complications in atrial fibrillation (AF) ablation, which often recovers spontaneously. However, the course of its recovery has not been examined fully, especially in regard to the different ablation methods. We sought to compare the recovery course of PNI in cryoballoon, laser balloon, and radiofrequency ablation. METHODS: This multicenter retrospective study analyzed 355 patients who suffered from PNI during AF ablation. PNI occurred during cryoballoon ablation (CB group) and laser balloon ablation (LB group) for a pulmonary vein isolation in 288 and 20 patients, and radiofrequency ablation for a superior vena cava (SVC) isolation (RF-SVC group) in 47 patients, respectively RESULTS: There was a significant difference in the estimated probability of PNI recovery after the procedure between the methods (p = 0.01). PNI recovered significantly earlier in the CB group, especially within 24 h and 3 months post-procedure (the percentage of the recovery within 24 h and 3 months: 49.7% and 71.5% in the CB group, 15.0% and 22.2% in the LB group, and 23.4% and 41.9% in the RF-SVC group, respectively). Persistent PNI after 12 months was observed in only seven patients in the CB group, one in the LB group, and four in the RF-SVC group, respectively. CONCLUSION: PNI rarely persists over 12 months after AF ablation; however, there is a difference in the timing of its recovery. PNI recovers quicker with cryoballoon ablation than with laser balloon ablation or radiofrequency ablation of the SVC.

Adjunctive posterior wall isolation for the treatment of persistent and longstanding persistent atrial fibrillation (CORNERSTONE AF) trial: Design and rationale.

BACKGROUND: A left atrial posterior wall isolation (LAPWI) is one of the atrial fibrillation (AF) ablation strategies. HYPOTHESIS: We hypothesized that an additional empirical LAPWI would increase the freedom from recurrent atrial arrhythmias as compared to standard AF ablation in persistent AF patients. METHODS: The CORNERSTONE AF study is a prospective, randomized, multicenter study investigating patients with AF persisting for >7 days and <3 years undergoing first-time AF ablation. They will be randomized to pulmonary vein isolation (PVI) or PVI + LAPWI in a 1:1 manner. Although PVI can be performed with either radiofrequency catheters or cryoballoons, only radiofrequency catheters will be permitted to achieve LAPWIs. Additional focal ablation targeting non-pulmonary vein triggers will be allowed. A total of 516 patients will be enrolled in 17 centers between August 2022 and February 2024 based on the calculation with 80% power, considering the assumption that 65% and 75% of the PVI and PVI + LAPWI group patients will be free from atrial arrhythmia recurrence 18-months postprocedure (10% of dropout). The primary endpoint is freedom from documented atrial arrhythmias 18 months postsingle procedures. Clinical follow-up will include 7-day ambulatory electrocardiograms and routine outpatient consultations by electrophysiologists at 1, 3, 6, 9, 12, and 18 months postprocedure. RESULTS: As of August 2023, a total of 331 patients (68 ± 9 years, 270 men, 43 longstanding persistent AF) have been enrolled. CONCLUSIONS: The CORNERSTONE AF study is a prospective, randomized, multicenter trial designed to evaluate the efficacy and safety of an adjunctive empirical LAPWI following standard AF ablation in persistent AF patients.

Treatment with catheter ablation for patients with arrhythmia-induced cardiomyopathy caused by atrial fibrillation promises a good prognosis.

Clinical outcomes after catheter ablation in patients with reduced left ventricular (LV) ejection fraction (EF) and atrial fibrillation (AF) remain unclear. This study aimed to explore the clinical outcomes of patients with arrhythmia-induced cardiomyopathy (AIC) and the influence of pharmacological treatment on clinical outcomes in patients with AIC after the procedure. Ninety-six patients with AF with a reduced LVEF (LVEF < 50%, 66.7 ± 10.9 years; 72 males) underwent AF ablation. AIC was defined as patients whose LVEF recovered ≥ 50% after catheter ablation (n = 67) and patients whose LVEF remained reduced were defined as non-AIC (n = 29). During a median follow-up of 25 (13-40) months, Kaplan-Meier analysis demonstrated that patients with AIC were associated with less frequent cardiovascular death (p = 0.025) and hospitalization for worsening heart failure (p < 0.001) than those without AIC. Freedom from AF recurrence was similar between the two groups (p = 0.47). In multivariate analysis, the LV end-diastolic diameter (p = 0.0002) and the CHA2DS2-VASc scores (p = 0.0062) were independent predictors of AIC. Among the 67 patients with AIC, no significant differences in baseline characteristics, except for LV chamber size and cryoballoon use, were observed between patients with AIC with (n = 31) and without renin-angiotensin system (RAS) inhibitors (n = 36). In the Kaplan-Meier analysis, cardiovascular death, hospitalization for worsening heart failure, and AF recurrence after catheter ablation did not differ between patients treated with and without RAS inhibitors (all p > 0.05). Catheter ablation in patients with AIC due to AF is associated with a good post-procedural prognosis.IRB information The study was approved by the Research Ethics Committee of the University of Fukui (No. 20220151) and clinical trial registration (UMIN000050391).

Can phrenic nerve injury be anticipated by larger cryoballoons?

Recently, a novel size-adjustable cryoballoon has been introduced in clinical practice, which can be inflated to two different diameters (28 and 31 mm). The 31 mm cryoballoon is specifically designed to achieve better contact with remodeled pulmonary veins (PVs) that have wider ostia while avoiding deep cannulation, thereby potentially reducing the risk of phrenic nerve injury (PNI) associated with deep balloon cannulation. However, we encountered two cases of PNI during cryoballoon ablation using the novel system among our initial 25 consecutive case series. Herein, we present two cases that exhibited PNI during freezing of the right superior PV with a size-adjustable balloon. While larger balloons are expected to create a larger area of isolation, the safety of this novel balloon system needs to be evaluated in a large-scale clinical study.

Characteristics of two different cryoballoon systems for treatment of paroxysmal atrial fibrillation: study protocol for a multicenter randomized controlled trial (CONTRAST-CRYO Trial).

BACKGROUND: Single-shot pulmonary vein isolation (PVI) utilizing cryothermal energy is an effective and safe treatment for atrial fibrillation (AF) patients. A novel cryoballoon system, POLARx™, has been recently introduced. The aim of this study was to compare the efficacy, safety, and biophysical parameters of PVI between the novel cryoballoon system, POLARx™, and the standard cryoballoon system, Arctic Front Advance Pro™ (AFA-Pro), in patients with paroxysmal AF. METHODS: The CONTRAST-CRYO trial is a prospective, multicenter, open-label, randomized controlled study performed at seven large cardiac centers. This study was approved by the central ethics committee or the local ethics committee of each participating hospital and has been registered at UMIN Clinical Trials Registry (UMIN000049948). The trial will assign 200 patients with paroxysmal AF undergoing PVI to POLARx™ and AFA-Pro in a 1:1 randomization. The primary endpoint is the one-shot acute success rate of the right inferior pulmonary vein. Second endpoints include freedom from documented atrial fibrillation, atrial flutter, or atrial tachycardia without antiarrhythmic drugs at 12 months after the procedure, freedom from re-do procedures, the incidence of procedure-related adverse events, freezing duration, and the biophysical parameters during applications for each PV, total procedure and fluoroscopy time, and PVI durability during re-do procedures. CONCLUSION: The CONTRAST-CRYO trial is a prospective, multicenter, randomized study designed to elucidate the difference in the efficacy, safety, and biophysical parameters between POLARx™ and AFA-Pro in paroxysmal AF patients undergoing PVI. The findings from this trial may provide a valuable indication for selecting the optimal cryoballoon system. CLINICAL TRIAL REGISTRATION:  UMIN000049948.

Acute procedural efficacy and safety of a novel expandable diameter cryoballoon in atrial fibrillation ablation: Early results from a multicenter ablation registry.

INTRODUCTION: The major limitation of the current cryoballoon (CB) system is a fixed 28 mm balloon-size. We sought to analyze real-world early experience with novel-sized adjustable CB. METHODS: This multicenter observational study included 140 consecutive atrial fibrillation patients (71 years, 94 men, 86 paroxysmal) who underwent pulmonary vein (PV) isolation using expandable diameter CB capable of ablation at 28 or 31 mm. RESULTS: Out of 544 targeted PVs, 526 (96.7%) were successfully isolated by a size-adjustable CB with a 770 [690-870] second median application dose, while the remaining 18 required touch-up ablation. Among them, 326 (62.0%) PVs were isolated by a 31 mm balloon, and the rate was significantly higher for upper than lower PVs (73.0% vs. 45.7%, p < .0001) and highest for right superior (78.5%) and lowest for right inferior (39.9%) PVs. The biophysical parameters and time to isolation were comparable between the 28 and 31 mm balloons, however, the real-time PV potential monitoring capability was significantly higher for 31 mm than 28 mm balloons for the left superior PV. The esophageal temperature reached 15°C during left inferior PV ablation significantly more often with 31 mm than 28 mm balloons (43.1% vs. 18.2%, p = .008). Right phrenic nerve injury (PNI) occurred in 9 (6.4%) patients during applications (6 right superior, 2 right inferior PVs), and most occurred with a 31 mm balloon. CONCLUSIONS: Our real-world early data demonstrated high acute efficacy and safety of the novel-sized adjustable CB. The biophysical parameters were similar between the 28 and 31 mm balloons. No marked decrease in the incidence of PNI was observed even with 31 mm balloons.