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.

Initial clinical experience with the novel POLARx FIT cryoballoon system for pulmonary vein isolation in patients with atrial fibrillation.

Background: The POLARx FIT system (Boston Scientific, MA, USA) is a novel cryoballoon (CB) ablation technology in which the balloon diameter can be expanded from 28 to 31 mm. The aim of this study was to compare the benefits and safety of the new POLARx FIT system to those of the existing POLARx system currently in use for pulmonary vein (PV) isolation (PVI) in patients with atrial fibrillation. Methods: The first 70 consecutive patients who underwent CB-based PVI with the POLARx FIT system were retrospectively compared with 200 consecutive patients treated with the POLARx system at Sakakibara Heart Institute from October 2021 to May 2023. Results: The POLARx FIT system yielded a higher mean ± standard deviation nadir temperature in the right inferior PV (-59.2 ± 5.29 °C vs. - 62.0 ± 5.08 °C, p = 0.006), but this required a balloon size reduction to 28 mm in 30 % of cases. No significant differences were detected in the time to isolation and thaw time of any PV between the two groups. After the CB-based PVI procedure, no residual PV carina potentials were observed with the POLARx FIT system, whereas 4/20 were with the POLARx system (p = 0.04). Conclusions: The POLARx FIT system had comparable effectiveness and safety to the basic POLARx system. This technology may improve the ablation area, including the PV carina. However, the 31-mm balloon alone was not sufficient to isolate certain PVs.

Impact of monitoring surface temperature during pulmonary vein isolation in a second-generation hot balloon system.

BACKGROUND: A surface temperature sensor can be used to visualize the effect of hot balloon (HB) catheters. This study evaluated the efficacy and safety of a second-generation HB system with surface temperature monitoring in patients with atrial fibrillation (AF). METHODS: Twenty patients (age: 69.6 ± 9.7 years, 11 male participants) who underwent first-time pulmonary vein isolation (PVI) using a second-generation HB were included. For each pulmonary vein (PV), the acute isolation rate and effective therapeutic range of surface temperature were investigated. RESULTS: Eighty-three PVs (including three right middle PVs) were isolated in 20 patients using an HB with a surface temperature sensor. Sixty-eight PVs were isolated using the first application. Fifteen PVs (left superior PV [LSPV], n = 7 [35%]; left inferior PV, n = 2 [10%]; right superior PV, n = 3 [15%]; right inferior PV, n = 3 [15%]) showed early intraoperative reconduction and required second applications. One LSPV required radiofrequency touch-up at the carina. The optimal balloon surface temperature and application time were evaluated, and a median value of 58 °C and integral value of 1000 °C·s were identified from the receiver operating characteristic curve to be useful effective indicators. However, for LSPV, the PV potential of carina or ridge likely often remained and needed to be independently considered. There was no periprocedural complication including severe pulmonary vein stenosis. During the observation period (median: 280 days, interquartile range: 261-318 days), 17 patients (85%) achieved and maintained sinus rhythm. CONCLUSIONS: Second-generation HBs with a surface temperature sensor are expected to provide favorable outcomes in AF ablation treatment.

Impact of high-density mapping on outcome of the second ablation for atrial fibrillation.

PURPOSE: Identification of a conduction gap between the left atrium and pulmonary vein (LA-PV gap) and the circuit of atrial tachycardia after pulmonary vein isolation (PVI) is an important process during the second ablation for atrial fibrillation (AF). The high-density mapping system RHYTHMIA® is useful for identification of an LA-PV gap and the circuit of atrial tachycardia. Therefore, this study was performed to investigate the effect of RHYTHMIA® in terms of the outcome of the second ablation for AF. METHODS: One hundred patients underwent a second ablation for AF in our institute from April 2015 to December 2018. We retrospectively evaluated 49 patients using RHYTHMIA® (group 1) and 51 patients using the conventional method with additional anatomical guide by CARTO® system. RESULTS: In group 1, we performed redo PVI for 41 patients with 49 LA-PV countable gaps and ablation for other atrial arrhythmias in 7 patients. In group 2, we performed redo PVI in 40 patients with 33 LA-PV countable gaps and ablation for other atrial arrhythmias in 9 patients. Three and two unstable arrhythmias in each group were not ablated. The final recurrence of atrial arrhythmia was significantly lower in group 1 than 2 (8/49 (16%) vs. 17/51 (33%), respectively; P = 0.017). Atrial arrhythmias other than AF after the second ablation occurred in only one patient in group 1 but seven patients in group 2. CONCLUSION: Using high-density mapping for the second ablation of AF was found to be superior to the conventional ablation method in terms of the suppression of atrial events in this study. This technique warrants further investigation.

Myopotential Oversensing Is a Major Cause of Inappropriate Shock in Subcutaneous Implantable Defibrillator in Japan.

Previous study has identified marked differences in patient characteristics and causes of inappropriate shock (IAS) between Japan and the Western societies in terms of subcutaneous implantable cardioverter-defibrillator (S-ICD). However, evidence of IAS in Asian populations including Japan has been limited to one observational study.Thus, we conducted a single-center registry study that tracks the postoperative course of 61 consecutive patients who received S-ICD from February 2016 to January 2020. Our findings showed that IAS occurred in 9.8% of the study population (6/61), which is comparable to the previously reported incidence. Remarkably, T-wave oversensing did not result in an IAS (0/6). Instead, myopotential oversensing was determined to have caused the most IAS events (4/6), while atrial fibrillation ranked second (2/6). A provocation maneuver (e.g., abdominal clench, push-ups, lifting a heavy item) reproduced myopotential noise disguised as R-waves, which should potentially trigger an IAS if uninterrupted. R-wave amplitude of the IAS group appeared relatively low compared to that of the non-IAS group although this finding was not tested significant. Furthermore, no temporal changes were noted in R-wave amplitude between the time of implantation and IAS events, suggesting that it is neither constantly low nor acutely dropped R-wave amplitude but a relatively high noise level that drives IAS. All the myopotential-IAS patients were found to be male. Right-sided lead implantation was associated with a higher incidence of IAS.This study highlights the fact that IAS continues to occur due to myopotential noise oversensing instead of T-wave oversensing. To minimize the risk of IAS, it is desirable to search and secure high R-wave voltage.