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.

Raise-up technique for the creation of left atrial roof lesion: A useful technique with cryoballoon for persistent atrial fibrillation.

INTRODUCTION: Recent studies have reported the efficacy of the cryoballoon (CB)-guided left atrial roof block line (LARB) creation in patients with persistent atrial fibrillation (AF). However, it can be technically challenging to attach the balloon to the left atrial (LA) roof due to its anatomical variations. We designed a new procedure called the "Raise-up Technique," which may facilitate the firm adhesion of the CB to the LA roof during freezing. This study aimed to evaluate the efficacy of the Raise-up technique in LARB creation. METHODS AND RESULTS: In total, 100 consecutive patients with persistent AF who underwent CB-LARB creation were enrolled. Fifty-seven patients underwent LARB creation using the Raise-up technique (Raise-up group), and the remaining 43 did not use it (control group). The Raise-up technique was performed as follows: An Achieve catheter was inserted as deeply as possible into the upper branch of the right superior pulmonary vein to anchor the CB. The balloon was placed below the targeted site on the LA roof and frozen. When the temperature of the CB reached approximately -10°C and the CB was easier to attach to the LA tissue, the CB was raised and pressed against the LA roof immediately by sheath advancement. Then the balloon could be in firm contact with the target site on the roof. If necessary, additional sheath advancement after sufficient freezing (-20°C to -30°C) was allowed the CB to have more firm and broad contact with the target site. LARB creation without touch-up ablation was achieved in 54 of 57 patients (94.7%) in the Raise-up group and 33 of 43 patients (76.7%) in the control group (p < .05). The lesion size of the LARB in the Raise-up group was significantly larger than that in the control group (15.2 cm2 vs. 12.8 cm2, p < .05). Moreover, the width of the LARB lesion in the Raise-up group was wider than that in the control group (32.0 mm vs. 26.6 mm, p < .05). CONCLUSION: The Raise-up technique enabled the creation of seamless and thick LARB lesions with a single stroke. In addition, the CB-LARB lesions created using the Raise-up technique tended to be large, resulting in extensive debulking of the LA posterior wall arrhythmia substrates. In CB ablation for persistent AF, the Raise-up technique can be considered one of the key strategies for LARB creation.

Edge AI Model Deployed for Real-Time Detection of Atrial Fibrillation Risk during Sinus Rhythm.

Objectives: The study aimed to develop a deep learning-based edge AI model deployed on electrocardiograph (ECG) devices for the real-time detection of atrial fibrillation (AF) risk during sinus rhythm (SR) using standard 10 s, 12-lead electrocardiograms (ECGs). Methods: A novel approach was used to convert standard 12-lead ECGs into binary images for model input, and a lightweight convolutional neural network (CNN)-based model was trained using data collected by the Japan Agency for Medical and Research Development (AMED) between 2019 and 2022. Patients over 40 years old with digital, SR ECGs were retrospectively enrolled and divided into AF and non-AF groups. The data labeling was supervised by cardiologists. The dataset was randomly allocated into training, validation, and internal testing datasets. External testing was conducted on data collected from other hospitals. Results: The best-trained model achieved an AUC of 0.82 and 0.80, sensitivity of 79.5% and 72.3%, specificity of 77.8% and 77.7%, precision of 78.2% and 76.4%, and overall accuracy of 78.6% and 75.0% in the internal and external testing datasets, respectively. The deployed model and app package utilized 2.5 MB and 40 MB of the available ROM and RAM capacity on the edge ECG device, correspondingly. The processing time for AF risk detection was approximately 2 s. Conclusions: The model maintains comparable performance and improves its suitability for deployment on resource-constrained ECG devices, thereby expanding its potential impact to a wide range of healthcare settings. Its successful deployment enables real-time AF risk detection during SR, allowing for timely intervention to prevent AF-related serious consequences like stroke and premature death.

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.

A Single Atrial Extrastimulation Resetting His Bundle During Supraventricular Tachycardia to Differentiate Atrial Tachycardia.

BACKGROUND: Catheter ablation is the curative treatment for paroxysmal supraventricular tachycardia (SVT). However, atrial tachycardia (AT) diagnosis is often challenging, especially when SVT is terminated by pacing. OBJECTIVES: This study sought to develop a novel method for AT diagnosis. METHODS: A total of 147 SVTs including 28 ATs, 87 atrioventricular nodal re-entrant tachycardias, and 32 orthodromic reciprocating tachycardias were prospectively studied. Single atrial extrastimulation was performed at the proximal coronary sinus from a coupling interval 20 milliseconds shorter than the tachycardia cycle length and gradually decreased until the His bundle (HB) was first reset and further until the SVT was terminated. The response of the SVT during the first HB resetting and the termination pattern were examined. RESULTS: In 27 of 28 ATs, tachycardia was unaffected when HB resetting whereas, in atrioventricular nodal re-entrant tachycardias or orthodromic reciprocating tachycardias (non-AT), tachycardia was simultaneously reset when HB resetting or was terminated with an atrio-Hisian block. When the coupling interval was further shortened for cases in which tachycardia persisted, all 33 SVTs with tachycardia termination with atrio-Hisian block were non-ATs, whereas 5 ATs and 7 non-ATs were terminated with Hisian-atrial block. The sensitivity, specificity, and positive and negative predictive values of the pattern of tachycardia that was unaffected when HB resetting for AT diagnosis were 96%, 100%, 100%, and 99%, respectively. Those of the pattern of tachycardia termination with atrio-Hisian block for non-AT diagnosis were 92%, 100%, 100%, and 42%, respectively. CONCLUSIONS: Single atrial extrastimulation from the proximal coronary sinus during tachycardia was useful and effective for AT diagnosis.

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.

Prevalence of amyloid deposition and cardiac amyloidosis in shoulder disease compared to carpal tunnel syndrome.

Background: Cardiac amyloidosis is a fatal disease of severe heart failure caused by the accumulation of amyloid in the myocardium. This disease is often advanced by the time cardiac symptoms appear; therefore, early detection and treatment are critical for a good prognosis. Recently, it has been suggested that cardiac amyloidosis is implicated in several orthopedic diseases, including carpal tunnel syndrome (CTS), which is often reported to precede cardiac dysfunction. Shoulder disease has also been suggested to be associated with cardiac amyloidosis; however, there have been no reports investigating the rate of amyloid deposition in shoulder specimens and the simultaneous prevalence of cardiac amyloidosis. Herein, we investigated the prevalence of intraoperative specimen amyloid deposition and cardiac amyloidosis in shoulder disease and CTS to determine the usefulness of shoulder specimen screening as a predictor of cardiac amyloidosis development. Methods: A total of 41 patients undergoing arthroscopic shoulder surgery and 33 patients undergoing CTS surgery were enrolled in this study. The shoulder group included rotator cuff tears, contracture of the shoulder, synovitis, and calcific tendonitis. In the shoulder group, a small sample of synovium and the long head of the biceps brachii tendon were harvested, while the transverse carpal ligament was harvested from the CTS group. The intraoperative specimens were pathologically examined for amyloid deposition, and patients with amyloid deposition were examined for the presence of cardiac amyloidosis by cardiac evaluation. Results: In the shoulder group, three cases (7.3%) of transthyretin amyloid deposition were found, all of which involved rotator cuff tears. None of these three cases with amyloid deposition were associated with cardiac amyloidosis. When examining the specimens, the amyloid deposition rate in the long head of the biceps brachii tendon was higher than that in the synovium. In the CTS group, 12 cases (36.4%) of transthyretin amyloid deposition were observed. Of these cases, seven underwent cardiac evaluation and two were identified with cardiac amyloidosis. Conclusion: While the prevalence of amyloid deposition and cardiac amyloidosis in the CTS group was consistent with previous reports, the shoulder group showed a lower deposition rate and no concomitant cardiac amyloidosis. Therefore, it remains debatable whether investigating amyloid deposition in samples obtained from shoulder surgery is beneficial for the early detection of cardiac amyloidosis.

Differential Pacing Maneuver From the Vein of Marshall.

BACKGROUND: Bidirectional mitral isthmus (MI) block is conventionally verified by differential pacing from the coronary sinus (CS) and its sequence change. This study aimed to evaluate the ability of differential pacing from the vein of Marshall (VOM) to detect epicardial MI connections. METHODS: Radiofrequency and VOM ethanol MI ablation were performed with a VOM electrode catheter inserted to the septal side of the ablation line. MI block was verified using conventional CS pacing. To perform differential VOM pacing analysis, initial pacing was delivered from a distal VOM bipole closer to the block line, and then from a proximal VOM bipole. The intervals from pacing stimulus during different VOM pacing sites to the electrogram recorded through the CS catheter on the opposite side of the line were compared. When the interval during distal VOM pacing was longer than that during proximal VOM pacing, it indicated a VOM connection block; however, if the former interval was shorter, the connection through the VOM was considered persistent. RESULTS: Overall, 50 patients were evaluated. According to CS pacing, MI ablation was incomplete in 9 patients, in whom the analysis indicated persistent VOM connection. Among 41 patients with complete MI block, confirmed by CS finding, in 30 (73%) patients, the interval during distal VOM pacing was longer than that during proximal VOM pacing by 11±5 ms. However, in 11 patients (27%) the former interval was revealed to be shorter than the latter by 16±8 ms, indicating residual VOM connection. Conduction time across the line was significantly shorter in 11 patients than in the other 30 (166±21 versus 197±36 ms; P<0.01). Ten successful reevaluated analyses after VOM ethanol and further radiofrequency ablation of the connection indicated VOM block achievement. CONCLUSIONS: Differential VOM pacing maneuver reflects the VOM conduction status. This maneuver can uncover residual epicardial connections that are missing with CS pacing.

Sacubitril/valsartan attenuates atrial conduction disturbance and electrophysiological heterogeneity with ameliorating fibrosis in mice.

Background: Sacubitril/valsartan (SacVal) has been shown to improve the prognosis of heart failure; however, whether SacVal reduces the occurrence of atrial fibrillation (AF) in heart failure has not yet been elucidated. In this study, we aimed to determine whether SacVal is effective in reducing the occurrence of AF in heart failure and identify the underlying mechanism of its electrophysiological effect in mice. Methods: Adult male mice underwent transverse aortic constriction, followed by SacVal, valsartan, or vehicle treatment for two weeks. Electrophysiological study (EPS) and optical mapping were performed to assess the susceptibility to AF and the atrial conduction properties, and fibrosis was investigated using heart tissue and isolated cardiac fibroblasts (CFs). Results: EPS analysis revealed that AF was significantly less inducible in SacVal-treated mice than in vehicle-treated mice. Optical mapping of the atrium showed that SacVal-treated and valsartan-treated mice restored the prolonged action potential duration (APD); however, only SacVal-treated mice showed the restoration of decreased conduction velocity (CV) compared to vehicle-treated mice. In addition, the electrophysiological distribution analysis demonstrated that heterogeneous electrophysiological properties were rate-dependent and increased heterogeneity was closely related to the susceptibility to AF. SacVal attenuated the increased heterogeneity of CV at short pacing cycle length in atria, whereas Val could not. Histological and molecular evaluation showed that SacVal exerted the anti-fibrotic effect on the atria. An in vitro study of CFs treated with natriuretic peptides and LBQ657, the metabolite and active form of sacubitril, revealed that C-type natriuretic peptide (CNP) combined with LBQ657 had an additional anti-fibrotic effect on CFs. Conclusions: Our results demonstrated that SacVal can improve the conduction disturbance and heterogeneity through the attenuation of fibrosis in murine atria and reduce the susceptibility of AF in heart failure with pressure overload, which might be attributed to the enhanced function of CNP.

Validation of dual atrioventricular nodal physiology in dual atrioventricular nodal non-reentrant tachycardia via adenosine triphosphate injection during atrial pacing: A novel insight into the role of leftward inferior extension.

INTRODUCTION: Dual atrioventricular nodal non-reentrant tachycardia (DAVNNT) is a rare and challenging-to-diagnose arrhythmia, without previous reports associating it with a leftward inferior extension (LIE). METHODS: Diagnosis was made using adenosine triphosphate (ATP) injection during atrial pacing in a suspected DAVNNT patient. RESULTS: Ablation of the rightward inferior extension was unsuccessful in eliminating DAVNNT; however, subsequent ablation of the LIE successfully eradicated the arrhythmia. CONCLUSION: This unique case, marked by the first instance of DAVNNT caused by LIE, diagnosed through ATP injection, underscores the utility of this diagnostic approach and broadens the spectrum of our understanding and management of this condition.

Noninvasive transthoracic doppler flow velocity and invasive thermodilution to assess coronary flow reserve.

Background: Coronary flow reserve (CFR) provides prognostication and coronary physiological information, including epicardial coronary stenosis and microvascular function. The relationship between stress transthoracic Doppler echocardiography (TDE)-derived coronary flow velocity reserve (CFRS-TDE) and thermodilution-derived coronary flow reserve (CFRthermo) before and after elective percutaneous coronary intervention (PCI) remains unclear. Methods: This single-center prospective registry study evaluated patients who underwent fractional flow reserve (FFR)-guided elective PCI for left anterior descending artery (LAD) lesions with wire-based invasive physiological measurements and pre- and post-PCI stress TDE examinations. Results: A total of 174 LAD lesions from 174 patients were included in the final analysis. A modest correlation was detected between the pre-PCI CFRS-TDE and the pre-PCI CFRthermo (r=0.383, P<0.001). The frequently used CFRS-TDE threshold of 2.0 corresponded to a pre-PCI CFRthermo of 2.18. Pre-PCI CFRS-TDE underestimated pre-PCI CFRthermo [1.89 (1.44-2.31) vs. 2.05 (1.38-2.93), P<0.001]. Both CFRS-TDE and CFRthermo increased significantly post-PCI [pre-PCI CFRS-TDE 1.89 vs. post-PCI CFRS-TDE 2.33, P<0.001; pre-PCI CFRthermo 2.05 (1.38-2.93) vs. post-PCI CFRthermo 2.59 (1.63-3.55), P<0.001]. In contrast, there was no significant relationship between changes in CFRS-TDE and changes in CFRthermo after PCI (r=0.008, P=0.915) or between post-PCI CFRS-TDE and post-PCI CFRthermo (r=0.054, P=0.482). Conclusions: Pre-PCI CFRS-TDE and CFRthermo are modestly correlated, but post-PCI CFRS-TDE and CFRthermo have no correlation. CFRS-TDE and CFRthermo are not interchangeable, particularly post-PCI, suggesting that the two metrics represent different coronary physiologies after PCI.

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.

Detection of unrecognized myocardial infarction by preprocedural transthoracic echocardiography in patients undergoing elective percutaneous coronary intervention.

BACKGROUND: Previous studies showed that unrecognized myocardial infarction (UMI) identified on cardiac magnetic resonance (CMR) was related to worse prognosis. We aimed to investigate the efficacy of preprocedural transthoracic echocardiography (TTE) to detect the presence of UMI in patients undergoing percutaneous coronary intervention (PCI). METHODS: A total of 138 patients with chronic coronary syndrome (CCS) and preserved left ventricular ejection fraction (LVEF) without history of myocardial infarction or revascularization were retrospectively studied. UMI was evaluated with pre-PCI late gadolinium enhancement (LGE)-CMR. TTE and two-dimensional speckle-tracking echocardiography (2D-STE) were performed before PCI. All patients were divided into two groups according to the presence or absence of UMI, and clinical and echocardiographic findings were compared between these two groups. RESULTS: UMI was detected in 43 patients (31.2%). Multivariable logistic regression analysis revealed that higher SYNTAX score, the presence of wall motion abnormalities (WMAs) and lower global longitudinal strain (GLS) were independent predictors of the presence of UMI. Furthermore, GLS provided incremental efficacy for the detection of UMI over abnormal Q waves, SYNTAX score and WMAs. CONCLUSIONS: Preprocedural TTE in combination with 2D-STE could help identify patients with UMI regardless of the presence or absence of ECG findings and WMAs.

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.

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.

PCSK9 inhibitor use during pregnancy in a case of familial hypercholesterolemia complicated with coronary artery disease.

Limited data have been reported on the use of proprotein convertase subtilisin/kexin type 9 (PCSK 9) inhibitors during pregnancy in women with familial hypercholesterolemia (FH). Here, we present the first case of initiating evolocumab (PCSK9 inhibitor) in a compound heterozygous FH mother. The patient was a 34-year-old primipara with severe dyslipidemia and a history of coronary artery bypass surgery. An elevated low-density lipoprotein cholesterol (LDL-C) level of 420 mg/dL was detected in the first trimester and persistently increased throughout pregnancy. Evolocumab was administered at 31 and 35 weeks of gestation, showing a positive effect on stabilizing LDL-C levels. Planned delivery with labor analgesia was performed at 38 + 4 weeks. Both the mother and infant were discharged without any notable complications. Hence, evolocumab, an IgG2 monochromatic antibody with little placental permeability, may be an alternative medication with limited influence on infants. Further studies are needed to assess the safety of evolocumab administration during pregnancy.

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.

Novel method to avoid serious injurious effects on the atrioventricular nodal (AVN) conduction during catheter ablation of the AVN slow pathway utilizing cryofreezing energy.

BACKGROUND: Slow pathway elimination of the atrioventricular node (AVN) is essential to treat AVN reentrant tachycardia (AVNRT). However, injury to the AVN conduction (IAVN) is one of the serious complications. Cryofreezing energy is expected to reduce the incidence of IAVN. This study aimed to investigate the usefulness of a novel method to avoid IAVN during cryoablation of AVNRT. METHODS: A total of 157 patients (average age, 65.8 years; male, 71) suffering from AVNRT were included. Once the AVNRT terminated during cryo-ablation, then rapid atrial constant pacing (RACP) was performed during freezing at a rate lower 10 bpm than that inducing Wenchebach AV block in 74 (47.1 %) patients (Group A). The RACP rate was decreasingly reduced by 10 bpm in case of the occurrence of IAVN. When the RACP reached 100 bpm, the cryoablation was prematurely terminated. Group B patients (83 = 52.9 %) underwent cryoablation during sinus rhythm. All patients were allocated in a randomized fashion. We compared the severity of the IAVN between Groups A and B. RESULTS: There were no significant differences at 12 months regarding the freedom from the AVNRT between Groups A and B. However, the duration of the IAVN was significantly longer in Group B than A (p = 0.02). There were no significant differences regarding the distance between the His recording sites and successful ablation sites between Groups A and B. No permanent IAVN requiring pacemaker implantation was provoked in either group. CONCLUSION: RACP was useful to avoid sustained and serious IAVN during cryoablation of AVNRT.

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.