Impact of pulsed field ablation on intraluminal esophageal temperature.

INTRODUCTION: Atrio-esophageal fistula after esophageal thermal injury (ETI) is one of the most devastating complications of available energy sources for atrial fibrillation (AF) ablation. Pulsed field ablation (PFA) uses electroporation as a new energy source for catheter ablation with promising periprocedural safety advantages over existing methods due to its unique myocardial tissue sensitivity. In preclinical animal studies, a dose-dependent esophageal temperature rise has been reported. In the TESO-PFA registry intraluminal esophageal temperature (TESO) changes in a clinical setting are evaluated. METHODS: Consecutive symptomatic AF patients (62 years, 67% male, 61% paroxysmal AF, CHA2 DS2 Vasc Score 2) underwent first-time PFA and were prospectively enrolled into our registry. Eight pulse trains (2 kV/2.5 s, bipolar, biphasic, x4 basket/flower configuration each) were delivered to each pulmonary vein (PV). Two extra pulse trains per PV in flower configuration were added for wide antral circumferential ablation. Continuous intraluminal esophageal temperature (TESO) was monitored with a 12-pole temperature probe. RESULTS: Median TESO change was statistically significant and increased by 0.8 ± 0.6°C, p < .001. A TESO increase ≥ 1°C was observed in 10/43 (23%) patients. The highest TESO measured was 40.3°C. The largest TESO difference (∆TESO) was 3.7°C. All patients remained asymptomatic considering possible ETI. No atrio-esophageal fistula was reported on follow-up. CONCLUSION: A small but significant intraluminal esophageal temperature rise can be observed in most patients during PFA. TESO rise over 40°C is rare. The clinical implications of the observed findings need to be further evaluated.

Venous vascular closure system vs. figure-of-eight suture following atrial fibrillation ablation: the STYLE-AF Study.

AIMS: Simplified ablation technologies for pulmonary vein isolation (PVI) are increasingly performed worldwide. One of the most common complications following PVI are vascular access-related complications. Lately, venous closure systems (VCSs) were introduced into clinical practice, aiming to reduce the time of bed rest, to increase the patients' comfort, and to reduce vascular access-related complications. The aim of the present study is to compare the safety and efficacy of using a VCS to achieve haemostasis following single-shot PVI to the actual standard of care [figure-of-eight suture and manual compression (MC)]. METHODS AND RESULTS: This is a prospective, multicentre, randomized, controlled, open-label trial performed at three German centres. Patients were randomized 1:1 to undergo haemostasis either by means of VCS (VCS group) or of a figure-of-eight suture and MC (F8 group). The primary efficacy endpoint was the time to ambulation, while the primary safety endpoint was the incidence of major periprocedural adverse events until hospital discharge. A total of 125 patients were randomized. The baseline characteristics were similar between the groups. The VCS group showed a shorter time to ambulation [109.0 (82.0, 160.0) vs. 269.0 (243.8, 340.5) min; P < 0.001], shorter time to haemostasis [1 (1, 2) vs. 5 (2, 10) min; P < 0.001], and shorter time to discharge eligibility [270 (270, 270) vs. 340 (300, 458) min; P < 0.001]. No major vascular access-related complication was reported in either group. A trend towards a lower incidence of minor vascular access-related complications on the day of procedure was observed in the VCS group [7 (11.1%) vs. 15 (24.2%); P = 0.063] as compared to the control group. CONCLUSION: Following AF ablation, the use of a VCS results in a significantly shorter time to ambulation, time to haemostasis, and time to discharge eligibility. No major vascular access-related complications were identified. The use of MC and a figure-of-eight suture showed a trend towards a higher incidence of minor vascular access-related complications.

Sex differences among subcutaneous implantable cardioverter-defibrillator recipients: a propensity-matched, multicentre, international analysis from the i-SUSI project.

AIMS: Women have been historically underrepresented in implantable cardioverter-defibrillator (ICD) trials. No data on sex differences regarding subcutaneous ICDs (S-ICD) carriers have been described. Aim of our study was to investigate sex-related differences among unselected S-ICD recipients. METHODS AND RESULTS: Consecutive patients enrolled in the multicentre, international i-SUSI registry were analysed. Comparisons between sexes were performed using a 1:1 propensity matching adjusted analysis for age, body mass index (BMI), left ventricular function, and substrate. The primary outcome was the rate of appropriate shocks during follow-up. Inappropriate shocks and other device-related complications were deemed secondary outcomes. A total of 1698 patients were extracted from the i-SUSI registry; 399 (23.5%) were females. After propensity matching, two cohorts of 374 patients presenting similar baseline characteristics were analysed. Despite similar periprocedural characteristics and a matched BMI, women resulted at lower risk of conversion failure as per PRAETORIAN score (73.4% vs. 81.3%, P = 0.049). Over a median follow-up time of 26.5 [12.7-42.5] months, appropriate shocks were more common in the male cohort (rate/year 3.4% vs. 1.7%; log-rank P = 0.049), while no significant differences in device-related complications (rate/year: 6.3% vs. 5.8%; log-rank P = 0.595) and inappropriate shocks (rate/year: 4.3% vs. 3.1%; log-rank P = 0.375) were observed. After controlling for confounders, sex remained significantly associated with the primary outcome (aHR 1.648; CI 0.999-2.655, P = 0.048), while not resulting predictor of inappropriate shocks and device-related complications. CONCLUSION: In a propensity-matched cohort of S-ICD recipients, women are less likely to experience appropriate ICD therapy, while not showing higher risk of device-related complications. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT0473876.

Impact of ventricular tachycardia ablation in subcutaneous implantable cardioverter defibrillator carriers: a multicentre, international analysis from the iSUSI project.

AIMS: Catheter ablation (CA) of ventricular tachycardia (VT) has become an important tool to improve clinical outcomes in patients with appropriate transvenous implantable cardioverter defibrillator (ICD) shocks. The aim of our analysis was to test whether VT ablation (VTA) impacts long-term clinical outcomes even in subcutaneous ICD (S-ICD) carriers. METHODS AND RESULTS: International Subcutaneous Implantable Cardioverter Defibrillator (iSUSI) registry patients who experienced either an ICD shock or a hospitalization for monomorphic VT were included in this analysis. Based on an eventual VTA after the index event, patients were divided into VTA+ vs. VTA- cohorts. Primary outcome of the study was the occurrence of a combination of device-related appropriate shocks, monomorphic VTs, and cardiovascular mortality. Secondary outcomes were addressed individually. Among n = 1661 iSUSI patients, n = 211 were included: n = 177 experiencing ICD shocks and n = 34 hospitalized for VT. No significant differences in baseline characteristics were observed. Both the crude and the yearly event rate of the primary outcome (5/59 and 3.8% yearly event rate VTA+ vs. 41/152 and 16.4% yearly event rate in the VTA-; log-rank: P value = 0.0013) and the cardiovascular mortality (1/59 and 0.7% yearly event rate VTA+ vs. 13/152 and 4.7% yearly event rate VTA-; log-rank P = 0.043) were significantly lower in the VTA + cohort. At multivariate analysis, VTA was the only variable remaining associated with a lower incidence of the primary outcome [adjusted hazard ratio 0.262 (0.100-0.681), P = 0.006]. CONCLUSION: In a real-world registry of S-ICD carriers, the combined study endpoint of arrhythmic events and cardiovascular mortality was lower in the patient cohort undergoing VTA at long-term follow-up. CLINICALTRIALS.GOV IDENTIFIER: NCT0473876.

Left Atrial Reservoir Strain and Recurrence of Atrial Fibrillation Following De-Novo Pulmonary Vein Isolation　- Results of the ASTRA-AF Pilot Study.

BACKGROUND: Achieving early rhythm control and maintaining sinus rhythm are associated with improved outcomes in patients with atrial fibrillation (AF). Pulmonary vein isolation (PVI) is a validated alternative to medical rhythm control. This study determined associations between left atrial strain reservoir (LASR) and AF recurrence after PVI.Methods and Results: In all, 132 patients (88 with paroxysmal AF [PAF], 44 with persisting AF [PersAF]) who presented in sinus rhythm for de novo PVI of AF between December 2017 and January 2019 were included in the study. All patients underwent preprocedural echocardiography. After 12 months, all patients underwent 24-h Holter electrocardiogram monitoring to screen for AF recurrence. Kaplan-Meier curve analysis revealed an association between decreasing LASRand increased AF recurrence, with a cut-off at 31.4%. In univariable Cox regression analysis, LASRdemonstrated an association with AF recurrence, with hazard ratios (HR) of 0.83 (95% confidence interval [CI] 073-0.93; P=0.001) per 5% increase in univariable models and 0.83 (95% CI 073-0.95; P=0.005) in multivariable analysis. When clinical variables with age, sex and type of AF (PAF/PersAF) were included in the multivariable analysis, LASRremained relevant in a model with age (HR 0.86; 95% CI 073-1.00; P=0.046). CONCLUSIONS: In patients undergoing de novo PVI for AF, LASRcould be of use in risk stratification regarding AF recurrence.

[ESC guidelines 2023 on the management of endocarditis : What is new?] / ESC-Leitlinien 2023 zum Management der Endokarditis : Was ist neu?

In August 2023 the new European guidelines on the management of infective endocarditis were published by the European Society of Cardiology (ESC). Numerous recommendations were revised and supplemented by new ones. This review article outlines the essential modifications of the current ESC guidelines focusing on the prevention including antibiotic prophylaxis, the role of the endocarditis team, the revision of the diagnostic criteria, the paradigm shift towards oral antibiotic treatment, the timing and the indications for surgical treatment as well as the relevance of infections of cardiovascular implantable electronic devices.

Very high-power short-duration ablation for pulmonary vein isolation utilizing a very-close protocol-the FAST AND FURIOUS PVI study.

AIMS: The very high-power short-duration (vHP-SD) radiofrequency (RF) ablation concept of atrial fibrillation (AF) treatment by pulmonary vein isolation (PVI) aims for safer, more effective, and faster procedures. Utilizing conventional ablation, the 'close protocol' has been verified. Since lesion formation of vHP-SD ablation creates wider but shallower lesions we adapted the close protocol to an individualized and tighter 'very-close protocol' of 3-4 mm of inter-lesion distance (ILD) at the anterior and 5-6 mm at the posterior aspect of the left atrium using vHP-SD only. Here, we evaluated the safety and efficacy of vHP-SD ablation for PVI utilizing a very-close protocol in comparison with standard ablation. METHODS AND RESULTS: A total of 50 consecutive patients with symptomatic AF were treated with a very-close protocol utilizing vHP-SD (vHP-SD group). The data were compared with 50 consecutive patients treated by the ablation-index-guided strategy (control group). The mean RF time was 352 ± 81 s (vHP-SD) and 1657 ± 570 s (control, P < 0.0001), and the mean procedure duration was 59 ± 13 (vHP-SD) and 101 ± 38 (control, P < 0.0001). The first-pass isolation rate was 74% (vHP-SD) and 76% (control, P = 0.817). Severe adverse events were reported in 1 (2%, vHP-SD) and 3 (6%, control) patients (P = 0.307). A 12-month recurrence-free survival was 78% (vHP-SD) and 64% (control, P = 0.142). PVI durability assessed during redo-procedures was 75% (vHP-SD) vs. 33% (control, P < 0.001). CONCLUSIONS: PVI solely utilizing vHP-SD via a very-close protocol provides safe and effective procedures with a high rate of first-pass isolations. The procedure duration and ablation time were remarkably low. A 12-month follow-up and PVI durability are promising.

Novel or established cryoballoon ablation system for pulmonary vein isolation: the prospective ICE-AGE-1 study.

AIMS: Catheter ablation with a cryoballoon (CB) provides effective and durable pulmonary vein (PV) isolation (PVI) associated with encouraging clinical outcome data. The novel POLARx CB incorporates unique features, which may translate into improved safety, efficacy, and outcomes. The ICE-AGE-1 study aimed to assess the efficacy, safety, and 1-year clinical follow-up of the POLARx CB in comparison to the Arctic Front Advance Pro CB (AF-CB4). METHODS AND RESULTS: A total of 103 consecutive patients with paroxysmal or persistent atrial fibrillation (AF) who underwent POLARx-based PVI (POLARx group) were prospectively enrolled and were compared to 102 consecutive patients previously treated with the AF-CB4 (AF-CB4 group). The mean age was 68.7 ± 10.2 (POLARx) and 65.7 ± 12 (AF-CB4, P = 0.0551) years. A total of 412 (POLARx) and 404 (AF-CB4) PVs were identified. All PVs, except for one PV in the POLARx group, were successfully isolated. A significant difference regarding the mean minimal CB temperature reached using the POLARx CB (-56.1 ± 8.3°C) and AF-CB4 (-46.9 ± 10.1°C) was observed (P < 0.0001). Real-time PVI was visualized in 71% of PVs in the POLARx group and 46% of them in the AF-CB4 group (P < 0.001). The mean procedure time was comparable: 54.5 ± 17.1 min for POLARx and 59.4 ± 18.6 min for AF-CB4 (P = 0.0509). No differences were observed in terms of periprocedural complications. There were comparable rates in freedom of AF or atrial tachycardia recurrence after 12 months, beyond a 90-day long blanking period: 78.9% in the POLARx group vs. 77.2% in the AF-CB4 group (P = 0.804). CONCLUSION: The novel POLARx CB showed similar safety, efficacy, and 1-year recurrence-free survival rates compared to the AF-CB4. A higher rate of real-time electrical PV recordings and significantly lower balloon temperatures were observed using the POLARx as compared to AF-CB4.

Pulsed Field Ablation-Based Pulmonary Vein Isolation Using a Simplified Single-Access Single-Catheter Approach　- The Fast and Furious PFA Study.

BACKGROUND: Pulsed field ablation (PFA) is a non-thermal energy source with promising safety and efficacy advantages. We aimed to develop a convenient, safe, effective and fast method of pulmonary vein isolation (PVI) utilizing a penta-spline PFA catheter via a single femoral vein and a venous closure system.Methods and Results: Consecutive patients (n=50; mean age: 63.6±10.7 years, 38% female) presenting with AF (paroxysmal AF: 56%) underwent first-time PVI via PFA. A single ultrasound-guided femoral vein puncture and a single transseptal puncture were used. After PVI using the penta-spline PFA catheter, extra pulse trains were added to the posterior wall for wide antral circumferential ablation. A venous closure system was used and a Donati suture was performed. The pressure bandage was removed after 1 h. A total of 196 PVs were identified and isolated with PFA only. The mean procedural time was 27.4±6.6 min, and the mean dwelling time was 14.4±5.5 min. Time to ambulation was 3.3±3.1 h. No severe complications occurred. During a mean follow-up of 6.5±2.1 months, 41/50 patients (82%) remained in sinus rhythm. CONCLUSIONS: The combination of a single venous puncture, single transseptal puncture approach using PFA and vascular closure device resulted in a 100% rate of acute PVI and an extraordinarily fast procedure and time to ambulation. The rate of periprocedural complications was low.

Concurrent hypoglossal and phrenic nerve stimulation in patients with obstructive and treatment emergent central sleep apnea.

BACKGROUND: Patients with obstructive or central sleep apnea are primarily treated with positive airway pressure treatment. There are novel implantable options targeting either obstructive sleep apnea using hypoglossal nerve stimulation (HNS) or central sleep apnea using phrenic nerve stimulation (PNS). METHODS: Patients with sleep apnea were implanted with both HNS and PNS devices, and their response to each therapy was monitored using home sleep tests as well as Epworth Sleepiness scale (ESS). RESULTS: We evaluated our concurrent neurostimulation approach in two patients. Both patients were implanted with two neuromodulation devices: The first case suffered from treatment emergent central sleep apnea after HNS activation for primarily obstructive sleep apnea (apnea-hypopnea index/AHI 54/h). The central portion resolved under PNS (AHI 23.7/h). The second case suffered from predominantly central sleep apnea (AHI 82/h). Here, the PNS device was implanted first, resulting in a subsequent reduction of the central portion. The residual obstructive sleep apnea was addressed using HNS (AHI 5.4/h). No interaction between the HNS and PNS systems was noticed in either of the two patients. CONCLUSIONS: In selected cases, a concurrent treatment with hypoglossal and phrenic nerve stimulation may lead to improvement of sleep apnea and patient satisfaction in a safe manner.

Has COVID-19 changed the spectrum of arrhythmias and the incidence of sudden cardiac death?

Arrhythmic manifestations of COVID-19 include atrial arrhythmias such as atrial fibrillation or atrial flutter, sinus node dysfunction, atrioventricular conduction abnormalities, ventricular tachyarrhythmias, sudden cardiac arrest, and cardiovascular dysautonomias including the so-called long COVID syndrome. Various pathophysiological mechanisms have been implicated, such as direct viral invasion, hypoxemia, local and systemic inflammation, changes in ion channel physiology, immune activation, and autonomic dysregulation. The development of atrial or ventricular arrhythmias in hospitalized COVID-19 patients has been shown to portend a higher risk of in-hospital death. Management of these arrhythmias should be based on published evidence-based guidelines, with special consideration of the acuity of COVID-19 infection, concomitant use of antimicrobial and anti-inflammatory drugs, and the transient nature of some rhythm disorders. In view of new SARS-CoV­2 variants that may evolve, the development and use of newer antiviral and immunomodulator drugs, and the increasing adoption of vaccination, clinicians must remain vigilant for other arrhythmic manifestations that may occur in association with this novel but potentially deadly disease.

Stand-alone Focal Impulse and Rotor Modulation (FIRM) ablation versus second-generation cryoballoon pulmonary vein isolation for paroxysmal atrial fibrillation.

INTRODUCTION: Focal Impulse and Rotor Modulation (FIRM) guided catheter ablation aiming at stable rotors has been investigated as a treatment option in patients with atrial fibrillation (AF). The objective of this study was to compare the safety and efficacy of FIRM-guided ablation with second-generation cryoballoon pulmonary vein isolation (CB2-PVI) in paroxysmal AF. METHODS: Consecutive patients (n = 22, mean age 60 ± 11 years, 59.1% of males) who were treated with a stand-alone FIRM-guided ablation were included in this retrospective single-center study. Procedural data and arrhythmia-free survival at 12 months were compared with n = 86 consecutive patients (mean age 62 ± 13 years, 62.4% of males) who received de-novo CB2-PVI. RESULTS: Median procedure duration was significantly longer in the FIRM group than in the CB2-PVI group (152 [IQR 120-176] minutes vs. 122 [110-145] minutes; p = .031). One patient (1.2%) in the CB2-PVI group and five patients (22.7%) in the FIRM group had vascular access complications. Atrial tachyarrhythmias recurred in 15 patients in the FIRM group and 11 in the CB2-PVI group. Kaplan-Meier estimation of single-procedure arrhythmia-free survival at 12 months was 25% (95% confidence interval [CI] 6%-44%) in the FIRM group and 87% (95% CI 78%-96%) in the CB2-PVI group (p < .001). Repeat ablations were performed in 14/20 (70.0%) patients in the FIRM group and in 12/85 (14.1%) in the CB2-PVI group (p < .001). CONCLUSION: De novo ablation of AF using FIRM-guided AF ablation results in shorter arrhythmia-free survival after 12 months compared to CB2-PVI and a need for repeat ablation in the majority of patients to achieve stable sinus rhythm.

Repeat catheter ablation in patients with atrial arrhythmia recurrence despite durable pulmonary vein isolation.

INTRODUCTION: Arrhythmia recurrence after pulmonary vein isolation (PVI) in patients with atrial fibrillation (AF) is common and often linked to pulmonary vein reconnection. In patients with arrhythmia recurrences despite durable PVI the optimal ablation approach is unclear. The purpose of the present study was to analyze efficacy of extended ablation maneuvers in these patients and predictors of procedural success. METHODS: Consecutive patients with durable PVI undergoing repeat ablation procedures were prospectively enrolled. Patients underwent substrate modification with creation of linear lesions and/or mechanism-specific atrial tachycardia (AT) ablation. Three dimensional-mapping images were analyzed for the presence of left atrial (LA) low-voltage areas according to published scoring systems. RESULTS: Seventy-four patients were analyzed. Mode of recurrence after durable PVI was AF in 27 patients (36.5%) and AT in 47 patients (63.5%). Linear lesion ablation was performed in 60 patients (81.1%). Twenty-four patients (32.4%) were treated for focal AT mechanisms. Mean follow-up was 565 ± 342 days. Estimated arrhythmia-free survival after 24 months was significantly higher in patients with AT than in patients with AF as mode of recurrence after durable PVI (42.9 ± 8.2% vs. 24.7 ± 8.5%, p = .023) and in patients without compared to patients with marked LA low-voltage areas (40.5 ± 9.2% vs. 22.8 ± 8.5%, p = .041). The mode of recurrence after durable PVI was the only independent predictor of further arrhythmia recurrence after repeat ablation. CONCLUSION: Arrhythmia-free survival following repeat ablation procedures in patients with durable PVI highly depends on mode of arrhythmia recurrence and the presence of LA low-voltage areas.

Individualized or fixed approach to pulmonary vein isolation utilizing the fourth-generation cryoballoon in patients with paroxysmal atrial fibrillation: the randomized INDI-FREEZE trial.

AIMS: Cryoballoon (CB) based pulmonary vein isolation (PVI) is a widely used technique for treatment of atrial fibrillation (AF); however the ideal energy dosing has not yet been standardized. This was a single-centre randomized clinical trial aiming at assessing the safety, acute efficacy, and clinical outcome of an individualized vs. a fixed CB ablation protocol using the fourth-generation CB (CB4) guided by pulmonary vein (PV) potential recordings and CB temperature. METHODS AND RESULTS: Patients were randomized in a 1:1 fashion to two different dosing protocols: INDI-FREEZE group (individualized protocol): freeze-cycle duration of time to effect plus 90 s or interruption of the freeze-cycle and repositioning CB if a CB temperature of -30°C was not within 40 s. Control group (fixed protocol): freeze-cycle duration of 180 s. No-bonus freeze-cycle was applied in either patient group. The primary endpoint was freedom from atrial tachyarrhythmia at 12 months. Secondary end points included procedural parameters and complications. A total of 100 patients with paroxysmal AF were prospectively enrolled. No difference was seen in the primary endpoint [INDI-FREEZE group: 38/47 (81%) vs. control group: 40/47, (85%), P = 0.583]. The total freezing time was significantly shorter in the INDI-FREEZE group (157 ± 56 s vs. 212 ± 83 s, P < 0.001), while procedure duration (57.9 ± 17.9 min vs. 63.2 ± 20.2 min, P = 0.172) was similar. No differences were seen in the minimum CB and oesophageal temperatures as well as in periprocedural complications. CONCLUSION: Compared to the fixed protocol, the individualized approach provides a similar safety profile and clinical outcome, while reducing the total freezing time.

[ESC guidelines 2021 on cardiac pacing and cardiac resynchronization therapy : What's new?] / ESC-Leitlinien 2021 zur Schrittmacher- und Resynchronisationstherapie : Was gibt es Neues?

The new European Society of Cardiology (ESC) guidelines on cardiac pacing and cardiac resynchronization therapy were presented together with the new ESC heart failure guidelines at the ESC congress in September. The new document includes detailed sections on patient evaluation and clinical assessment, implantation, minimizing complications and patient follow-up. The guidelines have been updated and expanded particularly on the approach to reflex syncope, the indications after transcatheter aortic valve implantation (TAVI) and the perioperative management. The indications for cardiac resynchronization therapy (CRT) are now in line with the simultaneously published ESC heart failure guidelines. New physiological forms of stimulation and leadless pacing are now included in the guidelines.

Intraprocedural PRAETORIAN score for early assessment of S-ICD implantation: A proof-of-concept study.

INTRODUCTION: The PRAETORIAN score (PS) was developed to assess the implant position and predict defibrillation success of the subcutaneous implantable cardioverter defibrillators (S-ICD). The main critique moved to the routine use of PS has been its postprocedural timing, that limits its usefulness on procedure guidance. The aim of this proof-of-concept study was to assess the feasibility of an intraprocedural use of PS. METHODS: Forty consecutive patients undergoing S-ICD implantation were enrolled. Intraprocedural PS (IP-PS) obtained with fluoroscopy before closure of the pocket and postprocedural PS (PP-PS) obtained with two-views chest X-ray were compared. Intraprocedural data and PS were compared with the historic cohorts of the involved institutions. RESULTS: When assessing IP-PS and PP-PS, a complete overall agreement was observed (100%, 1.00-κ; p < .001). When assessing a per-step agreement, a very high-degree of concordance in evaluating Step 1 of the PS was observed (95%, 0.81-κ; p < .001). A complete agreement in Step 2-3 (100%, 1.00-κ; p < .001) of the PS was reported. In comparison with our historical cohort, procedural time in the IP-PS cohort did not increase (45 [41-52] vs. 45 [39-49] min; p = .351) while the expected increase in fluoroscopy time resulted scarce (15 [10-15] s). CONCLUSION: An IP-PS can be reliably obtained using fluoroscopy guidance during S-ICD implantation, without a significant increase in procedural duration and may serve as guidance for implanting physicians, to avoid postprocedural S-ICD repositioning, leading to patient discomfort and significantly enhancing infective risks. IP-PS showed a very high agreement with the PP-PS obtained from two-views chest X-ray.

Experience and procedural efficacy of pulmonary vein isolation using the fourth and second generation cryoballoon: The shorter, the better?

BACKGROUND: The second-generation cryoballoon (CB2) provides effective and durable pulmonary vein isolation (PVI) associated with encouraging clinical outcome. The novel fourth-generation cryoballoon (CB4) incorporates a 40% shorter distal tip. This design change may translate into an increased rate of PVI real-time signal recording, facilitating an individualized ablation strategy using the time to effect (TTE). METHODS AND RESULTS: Three hundred consecutive patients with paroxysmal or persistent atrial fibrillation were prospectively enrolled. The first 150 consecutive patients underwent CB2 based PVI (CB2 group) and the last 150 consecutive patients were treated with the CB4 (CB4 group). A total of 594/594 (100%, CB4) and 589/594 (99.2%, CB2) pulmonary veins (PVs) were successfully isolated utilizing the CB4 and CB2, respectively (p = .283). The real-time PVI visualization rate was 47% (CB4) and 39% (CB2; p = .005) and the mean freeze cycle duration 200 ± 90 s (CB4) and 228 ± 110 s (CB2; p < .001), respectively. The total procedure time did not differ between the groups (CB4: 64 ± 32 min) and (CB2: 62 ± 29 min, p = .370). No differences in periprocedural complications were detected. CONCLUSIONS: A higher rate of real-time electrical PV recordings are seen using the CB4 as compared to CB2, which may facilitate an individualized ablation strategy using the TTE.

Focal Impulse and Rotor Modulation Ablation vs. Pulmonary Vein isolation for the treatment of paroxysmal Atrial Fibrillation: results from the FIRMAP AF study.

AIMS: Pulmonary vein isolation (PVI) is the gold standard for atrial fibrillation (AF) ablation. Recently, catheter ablation targeting rotors or focal sources has been developed for treatment of AF. This study sought to compare the safety and effectiveness of Focal Impulse and Rotor Modulation (FIRM)-guided ablation as the sole ablative strategy with PVI in patients with paroxysmal AF. METHODS AND RESULTS: We conducted a multicentre, randomized trial to determine whether FIRM-guided radiofrequency ablation without PVI (FIRM group) was non-inferior to PVI (PVI group) for treatment of paroxysmal AF. The two primary efficacy end points were (i) acute success defined as elimination of AF rotors (FIRM group) or isolation of all pulmonary veins (PVI group) and (ii) long-term success defined as single-procedure freedom from AF/atrial tachycardia (AT) recurrence 12 months after ablation. The study was closed early by the sponsor. At the time of study closure, any pending follow-up visits were waived. A total of 51 patients (mean age 63 ± 10.6 years, 57% male) were enrolled. All PVs were successfully isolated in the PVI group and all rotors were successfully eliminated in the FIRM group. Single-procedure effectiveness was 31.3% (5/16) in the FIRM group and 80% (8/10) in the PVI group at 12 months. Three vascular access complications occurred in the FIRM group. CONCLUSION: These partial study effectiveness results reinforce the importance of PVI in paroxysmal AF patients and indicate that FIRM-guided ablation alone (without PVI) is not an effective strategy for treatment of paroxysmal AF in most patients.

Supervised Obesity Reduction Trial for AF ablation patients: results from the SORT-AF trial.

AIMS: Weight management seems to be beneficial for obese atrial fibrillation (AF) patients; however, randomized data are sparse. Thus, this study aimed to investigate the influence of weight reduction on AF ablation outcomes. METHODS AND RESULTS: SORT-AF is an investigator-sponsored, prospective, randomized, multicentre, and clinical trial. Patients with symptomatic AF (paroxysmal or persistent) and body mass index (BMI) 30-40 kg/m2 underwent AF ablation and were randomized to either weight-reduction (group 1) or usual care (group 2), after sleep-apnoea-screening and loop recorder (ILR) implantation. The primary endpoint was defined as AF burden between 3 and 12 months after AF ablation. Overall, 133 patients (60 ± 10 years, 57% persistent AF) were randomized to group 1 (n = 67) and group 2 (n = 66), respectively. Complications after AF-ablation were rare (one stroke and no tamponade). The intervention led to a significant reduction of BMI (34.9 ± 2.6-33.4 ± 3.6) in group 1 compared to a stable BMI in group 2 (P < 0.001). Atrial fibrillation burden after ablation decreased significantly (P < 0.001), with no significant difference regarding the primary endpoint between the groups (P = 0.815, odds ratio: 1.143, confidence interval: 0.369-3.613). Further analyses showed a significant correlation between BMI and AF recurrence for patients with persistent AF compared with paroxysmal AF patients (P = 0.032). CONCLUSION: The SORT-AF study shows that AF ablation is safe and successful in obese patients using continuous monitoring via ILR. Although the primary endpoint of AF burden after ablation did not differ between the two groups, the effects of weight loss and improvement of exercise activity were beneficial for obese patients with persistent AF demonstrating the relevance of life-style management as an important adjunct to AF ablation in this setting. TRIAL REGISTRATION NUMBER: NCT02064114.

Novel Cryoballoon Ablation System for Single Shot Pulmonary Vein Isolation　- The Prospective ICE-AGE-X Study.

BACKGROUND: The arctic front cryoballoon (AF-CB) provides effective and durable pulmonary vein isolation (PVI) associated with encouraging clinical outcome. The POLARx cryoballoon incorporates unique features and design changes that may translate into improved efficacy, safety and further simplified balloon-based procedures. Efficacy and safety of the novel POLARx cryoballoon was compared to the fourth generation AF-CB (AF-CB4).Methods and Results:Twenty-five consecutive patients with paroxysmal or persistent atrial fibrillation were prospectively enrolled, underwent POLARx-based PVI (POLARx group) and were compared to 25 consecutive patients treated with the AF-CB4 (AF-CB4 group). All PVs were successfully isolated utilizing the POLARx and AF-CB4. A significant difference regarding the mean minimal cryoballoon temperatures reached using the AF-CB4 and POLARx (-50±6℃ vs. -57±7℃, P=0.004) was observed. Real-time PVI was visualized in 81% of POLARx patients and 42% of AF-CB4 patients (P<0.001). Utilizing the POLARx, a trend towards shorter median procedure time (POLARx: 45 [39, 53] min vs. AF-CB4: 55 [50, 60] min; P=0.062) was found. No differences were observed between AF-CB4 and POLARx concerning catheter maneuverability, catheter stability and periprocedural complications. CONCLUSIONS: The novel POLARx showed similar safety and efficacy compared to the AF-CB4. A higher rate of real-time PV recordings and significantly lower minimal balloon temperatures were observed using the POLARx.