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.

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.

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.

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.

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.

Symptomatic periesophageal vagal nerve injury by different energy sources during atrial fibrillation ablation.

Background: Symptomatic gastric hypomotility (SGH) is a rare but major complication of atrial fibrillation (AF) ablation, but data on this are scarce. Objective: We compared the clinical course of SGH occurring with different energy sources. Methods: This multicenter study retrospectively collected the characteristics and clinical outcomes of patients with SGH after AF ablation. Results: The data of 93 patients (67.0 ± 11.2 years, 68 men, 52 paroxysmal AF) with SGH after AF ablation were collected from 23 cardiovascular centers. Left atrial (LA) ablation sets included pulmonary vein isolation (PVI) alone, a PVI plus a roof-line, and an LA posterior wall isolation in 42 (45.2%), 11 (11.8%), and 40 (43.0%) patients, respectively. LA ablation was performed by radiofrequency ablation, cryoballoon ablation, or both in 38 (40.8%), 38 (40.8%), and 17 (18.3%) patients, respectively. SGH diagnoses were confirmed at 2 (1-4) days post-procedure, and 28 (30.1%) patients required re-hospitalizations. Fasting was required in 81 (92.0%) patients for 4 (2.5-5) days; the total hospitalization duration was 11 [7-19.8] days. After conservative treatment, symptoms disappeared in 22.3% of patients at 1 month, 48.9% at 2 months, 57.6% at 3 months, 84.6% at 6 months, and 89.7% at 12 months, however, one patient required surgery after radiofrequency ablation. Symptoms persisted for >1-year post-procedure in 7 patients. The outcomes were similar regardless of the energy source and LA lesion set. Conclusions: The clinical course of SGH was similar regardless of the energy source. The diagnosis was often delayed, and most recovered within 6 months, yet could persist for over 1 year in 10%.

Peri-procedural anticoagulation in patients with end-stage kidney disease undergoing atrial fibrillation ablation: results from the multicentre end-stage kidney disease-atrial fibrillation ablation registry.

AIMS: The optimal anticoagulation regimen in patients with end-stage kidney disease (ESKD) undergoing atrial fibrillation (AF) catheter ablation is unknown. We sought to describe the real-world practice of peri-procedural anticoagulation management in patients with ESKD undergoing AF ablation. METHODS AND RESULTS: Patients with ESKD on haemodialysis undergoing catheter ablation for AF in 12 referral centres in Japan were included. The international normalized ratio (INR) before and 1 and 3 months after ablation was collected. Peri-procedural major haemorrhagic events as defined by the International Society on Thrombosis and Haemostasis, as well as thromboembolic events, were adjudicated. A total of 347 procedures in 307 patients (67 ±9 years, 40% female) were included. Overall, INR values were grossly subtherapeutic [1.58 (interquartile range: 1.20-2.00) before ablation, 1.54 (1.22-2.02) at 1 month, and 1.22 (1.01-1.71) at 3 months]. Thirty-five patients (10%) suffered major complications, the majority of which was major bleeding (19 patients; 5.4%), including 11 cardiac tamponade (3.2%). There were two peri-procedural deaths (0.6%), both related to bleeding events. A pre-procedural INR value of 2.0 or higher was the only independent predictor of major bleeding [odds ratio, 3.3 (1.2-8.7), P = 0.018]. No cerebral or systemic thromboembolism occurred. CONCLUSION: Despite most patients with ESKD undergoing AF ablation showing undertreatment with warfarin, major bleeding events are common while thromboembolic events are rare.

Initial multicenter clinical experience with the first-generation endoscopic guided laser balloon in Japan.

BACKGROUND: Isolation of the pulmonary veins (PVs) is the golden standard for atrial fibrillation (AF) ablation. To achieve a permanent PV isolation, the endoscopic guided HeartLight laser balloon system was invented. We analyzed the safety and efficacy of this laser balloon system. METHODS AND RESULTS: Three hundred four patients from 21 investigational sites inside Japan were enrolled in this study. One thousand sixty-two out of 1175 PVs (90.4%) were isolated using the HeartLight laser balloon. The isolation rate of the left superior, left inferior, right superior, and right inferior PVs was 87.8%, 91.3%, 91.6%, and 92.1%, respectively. The procedure time, defined as the time from the venous access to taking out the balloon, was 155 ± 39 min. The fluoroscopic time was 44 ± 25 min. The mean follow-up period was 309 ± 125 days. The freedom from AF recurrence at 3 months was 89.0% and at 12 months 82.1%. Adverse events occurred in 22 patients (7.2%) including phrenic nerve injury lasting more than 3 months in 1.6% and strokes in 1.0% of the patients. CONCLUSIONS: This initial experience demonstrated that the laser balloon ablation was feasible for PV isolation in Japanese AF patients.

Impact of cryoballoon application abortion due to phrenic nerve injury on reconnection rates: a YETI subgroup analysis.

AIMS: Cryoballoon (CB)-based pulmonary vein isolation (PVI) is an effective treatment for atrial fibrillation (AF). The most frequent complication during CB-based PVI is right-sided phrenic nerve injury (PNI) which is leading to premature abortion of the freeze cycle. Here, we analysed reconnection rates after CB-based PVI and PNI in a large-scale population during repeat procedures. METHODS AND RESULTS: In the YETI registry, a total of 17 356 patients underwent CB-based PVI in 33 centres, and 731 (4.2%) patients experienced PNI. A total of 111/731 (15.2%) patients received a repeat procedure for treatment of recurrent AF. In 94/111 (84.7%) patients data on repeat procedures were available. A total of 89/94 (94.7%) index pulmonary veins (PVs) have been isolated during the initial PVI. During repeat procedures, 22 (24.7%) of initially isolated index PVs showed reconnection. The use of a double stop technique did non influence the PV reconnection rate (P = 0.464). The time to PNI was 140.5 ± 45.1 s in patients with persistent PVI and 133.5 ± 53.8 s in patients with reconnection (P = 0.559). No differences were noted between the two populations in terms of CB temperature at the time of PNI (P = 0.362). The only parameter associated with isolation durability was CB temperature after 30 s of freezing. The PV reconnection did not influence the time to AF recurrence. CONCLUSION: In patients with cryoballon application abortion due to PNI, a high rate of persistent PVI rate was found at repeat procedures. Our data may help to identify the optimal dosing protocol in CB-based PVI procedures. CLINICAL TRIAL REGISTRATION: https://clinicaltrials.gov/ct2/show/NCT03645577?term=YETI&cntry=DE&draw=2&rank=1 ClinicalTrials.gov Identifier: NCT03645577.

Efficacy of left atrial posterior wall isolation guided by lesion size prediction module for non-paroxysmal atrial fibrillation.

AIMS: The efficacy of left atrial posterior wall isolation (PWI) is controversial. Lesion durability may be a major cause of arrhythmia recurrence. The use of the lesion size prediction module improves lesion durability. This study aimed to compare the clinical outcomes of pulmonary vein isolation (PVI) alone and PWI in addition to PVI (PVI + PWI) in patients with non-paroxysmal atrial fibrillation (AF) using a lesion size prediction module. METHODS AND RESULTS: This study is a sub-analysis of the recently published prospective multicentre observational study called ALCOHOL-AF (association of alcohol consumption with outcome of catheter ablation of AF). In this sub-analysis, patients with non-paroxysmal AF in whom PVI alone or PVI + PWI was performed using the lesion size prediction module were included. Freedom from atrial tachyarrhythmia was compared between PVI alone and PVI + PWI groups using propensity score analyses. Of the 3474 patients registered in the ALCOHOL-AF study, 572 patients (age 65.6 ± 10.1 years, male 77.4%, longstanding persistent AF 25.5%) were included in this sub-analysis. We selected 212 patients treated with PVI alone and 212 treated with PVI + PWI using one-to-one propensity score matching. During the follow-up period, atrial tachyarrhythmia recurrence was documented in 92 (43.4%) and 50 (23.6%) patients in the PVI alone and PVI + PWI groups, respectively. Freedom from atrial tachyarrhythmia recurrence without anti-arrhythmic drugs after a single procedure was significantly higher in PVI + PWI than in PVI alone groups (hazard ratio: 0.452, 95% confidence interval: 0.308-0.664, P < 0.001). CONCLUSION: In this hypothesis-generating study, lesion size prediction module-guided PVI + PWI was associated with better clinical outcomes than PVI alone in patients with persistent or longstanding persistent AF.

Effect of isolation feasibility of non-pulmonary vein foci on efficacy of ablation for atrial fibrillation: comparison of the isolation and focal ablation methods.

PURPOSE: Atrial fibrillation (AF) mainly originates from the pulmonary vein (PV). However, some AF triggers originate from other sites, namely non-PV foci, which are related to recurrence after AF ablation. This study aimed to evaluate the effects of isolation feasibility (isolability) of non-PV foci on the efficacy of AF ablation. METHODS: Overall, 1855 patients with AF (age, 64.6 ± 10.9 years; 82% paroxysmal) underwent PV isolation, followed by induction and ablation of non-PV foci. Among them, 545 (29%) patients had non-PV foci; these patients were categorized into those with isolable non-PV foci (n = 196, 36%) and those with non-isolable non-PV foci (n = 349, 64%). RESULTS: During a mean follow-up of 31.2 ± 15.6 months, recurrence was higher in the non-isolable group than in the isolable group (34% vs. 19%, P < 0.01). Kaplan-Meier analyses revealed a significantly better 1-year clinical outcome in the isolable group than in the non-isolable group (88.0% vs. 78.4%, P < 0.001; hazard ratio (HR), 0.56; 95% confidence interval (CI), 0.39-0.81). This outcome was not inferior to that of patients without non-PV foci (88.3% vs. 90.8%, P = 0.81). The non-isolable group showed poorer clinical outcomes than patients without non-PV foci (78.4% vs. 90.8%, P < 0.001; HR, 1.37; 95% CI, 1.22-1.53). Cox regression analysis revealed that isolability (HR, 0.56; 95% CI, 0.36-0.89) and unmappability (HR, 2.89; 95% CI, 1.55-5.37) of non-PV foci were significant predictors of arrhythmia recurrence. CONCLUSION: The isolability of non-PV foci was a significant factor affecting the achievement of better clinical outcomes following AF ablation in patients with non-PV foci.

Optimal single procedure strategy of pulmonary vein isolation with cryoballoon or radiofrequency and non-pulmonary vein triggers ablation for non-paroxysmal atrial fibrillation.

Background: Limited data exist on pulmonary vein isolation (PVI) using cryoballoon (CB) or radiofrequency (RF) ablation and additional non-pulmonary vein trigger ablation for non-paroxysmal atrial fibrillation (non-PAF). We aimed to assess the outcomes of first-stage catheter ablation for non-PAF patients. Methods: Initial PVI was performed on 734 non-PAF patients (age: 64 ± 10 years; male: 584 (80%)) between September 2014 and June 2018 [315 (43%), CB ablation; 419 (57%), RF catheter]. A logistic regression model was used to match 257 pairs (514 patients) according to the propensity scores (CB or RF group). After PVI, additional non-PV trigger ablation was performed if induced by isoproterenol. We analysed the clinical outcomes of both groups. Results: The mean procedural time was significantly shorter in the CB group (125 [range, 89-165] min) than in the RF group (190 [160-224] min; P < 0.001). The 1-year Kaplan-Meier event rate revealed similar atrial fibrillation-free survival rates between the two groups (CB: 77.9%, RF: 82.3%; log-rank P = 0.111). The additional ablation percentage for non-PV foci (CB: 39%, RF: 41%; P = 0.653) and complication incidence (CB: 5%, RF: 4%; P = 0.670) were also similar. Conclusions: In non-PAF patients, the combination strategy of PVI using CB or RF ablation and non-PV trigger ablation achieved comparable outcomes.

The impact of lesion complexity on predicting mortality of coronary artery disease patients after out-of-hospital cardiac arrest.

INTRODUCTION: Coronary artery disease (CAD) is the most frequent cause of out-of-hospital cardiac arrest (OHCA). Nevertheless, there have been limited studies focusing on the impact of lesion complexity on resuscitated CAD patients. The purpose of the present study was to investigate the association between coronary lesion complexity and the mortality of CAD patients after OHCA. METHODS: From pooled database of two centers, which comprised 706 successfully resuscitated OHCA patients, 172 patients undergoing coronary angiography were retrospectively investigated. A total of 148 patients exhibited coronary stenosis on angiogram and were included in the final analysis. Baseline characteristics, pre-and post-hospital care, general status after resuscitation and angiographical findings were compared between the patients who deceased within 30 days and those who survived and the predictors of 30-day mortality were determined. RESULTS: Ninety-four patients (63.5%) survived at 30 days. Bystander cardiopulmonary resuscitation (CPR) (Odds ratio (OR) 0.36; 95% confidence interval (CI) 0.14-0.96; P = 0.041), revascularization of coronary stenosis (OR 0.15; 95% CI 0.19-0.86; P < 0.001), GRACE risk score (OR 1.04; 95% CI 1.02-1.05; P < 0.001) and SYNTAX score (OR 1.07; 95% CI 1.01-1.13; P = 0.025) were independent predictors of 30-day mortality. As multiple predictors such as bystander CPR, GRACE score and SYNTAX score were combined, the 30-day mortality gradually deteriorated. CONCLUSIONS: In addition to bystander CPR, GRACE score and revascularization, SYNTAX score independently predicted 30-day mortality of CAD patients after OHCA.

Cryoballoon ablation for paroxysmal atrial fibrillation in Japan: 2-year safety and efficacy results from the Cryo AF Global Registry.

PURPOSE: Catheter ablation is a recommended rhythm control therapy after failed or intolerant antiarrhythmic drug (AAD) treatment for patients with atrial fibrillation (AF). This study evaluates clinical performance and safety of pulmonary vein isolation (PVI) using the cryoballoon (Arctic Front Advance) in Japan. METHODS: Cryo AF Global Registry is a prospective, multi-center registry. Patients with paroxysmal AF (PAF) were treated at 10 Japanese hospitals. Efficacy was evaluated by freedom from a ≥ 30-s recurrence of AF/atrial flutter (AFL)/atrial tachycardia (AT), AF-related symptoms, and quality of life using the EQ-5D-3L questionnaire. The safety endpoint was serious device- and procedure-related adverse events. RESULTS: The study included 352 patients with PAF (65 ± 10 years of age, 36% female, 36% without prior failure of AAD). Mean duration since first diagnosis of AF was 3.0 ± 5.5 years. Serious device- and procedure-related adverse event rate was 2.6% (95% CI: 1.2-4.8%). Freedom from AF/AFL/AT was 88.5% (95% CI: 84.7-91.4%) at 12 months and 86.7% (95% CI: 81.1-90.8%) at 24 months. The number of patients with ≥ 1 AF symptom was significantly decreased from 88% at enrollment to 22% (p < 0.01) at 12-month follow-up. General quality of life using EQ-5D did not improve significantly after 12 months in the summary score. However, in the visual analog scale score, there was improvement (5.8 ± 18.4; p < 0.01). CONCLUSIONS: This study demonstrates that cryoablation used for PVI is a safe and effective treatment in real-world use for patients with PAF in Japan.

Novel lead anchor technique using an active fixation quadripolar left ventricular lead in cardiac resynchronization therapy.

In this report, we present a case of successful advancement of a LV lead into tortuous vessels. This was achieved by deep engagement of the coronary sinus with a cannulation catheter by applying the anchor technique using the Medtronic Attain Stability Quad lead.

Complications and mortality after catheter ablation of ventricular arrhythmias: risk in VT ablation (RIVA) score.

AIMS: Catheter ablation of ventricular arrhythmias (VA) has proven to be an effective therapeutic option for secondary arrhythmia prophylaxis. We sought to assess the procedural efficacy, safety and in-hospital mortality of a large patient cohort with and without structural heart disease undergoing VA ablation. METHODS: A total of 1417 patients (804 patients with structural heart disease) undergoing 1792 endo- and epicardial procedures were analyzed. Multivariable risk factor analysis for occurrence of major complications and intrahospital mortality was obtained and a score to allow preprocedural risk assessment for patients undergoing VA ablation procedures was established. RESULTS: Major complication occurred in 4.4% of all procedures and significantly more often in patients with structural heart disease than in structurally normal hearts (6.0 vs. 1.8%). The frequency of these periprocedural complications was significantly different between procedures with sole right ventricular and a combination of RV and LV access (0.5 vs. 3.1%). The most common complication was cardiac tamponade in 46 cases (3.0%). Intrahospital death was observed in 32 patients (1.8%). Logistic regression model revealed presence of ischemic heart disease, epicardial ablation, presence of oral anticoagulation or dual antiplatelet therapy as independent risk factors for the occurrence of complications or intrahospital death, while a history of previous heart surgery was an independent predictor with a decreased risk. Based on this analysis a risk score incorporating 5 standard variables was established to predict the occurrence of complications and intrahospital mortality. CONCLUSIONS: Safety of VA catheter ablation mainly relies on patient baseline characteristics and the type of access into the ventricles or epicardial space.