Safety and Effectiveness of Pulsed Field Ablation to Treat Atrial Fibrillation: One-Year Outcomes From the MANIFEST-PF Registry.

BACKGROUND: Pulsed field ablation is a novel nonthermal cardiac ablation modality using ultra-rapid electrical pulses to cause cell death by a mechanism of irreversible electroporation. Unlike the traditional ablation energy sources, pulsed field ablation has demonstrated significant preferentiality to myocardial tissue ablation, and thus avoids certain thermally mediated complications. However, its safety and effectiveness remain unknown in usual clinical care. METHODS: MANIFEST-PF (Multi-National Survey on the Methods, Efficacy, and Safety on the Post-Approval Clinical Use of Pulsed Field Ablation) is a retrospective, multinational, patient-level registry wherein patients at each center were prospectively included in their respective center registries. The registry included all patients undergoing postapproval treatment with a multielectrode 5-spline pulsed field ablation catheter to treat atrial fibrillation (AF) between March 1, 2021, and May 30, 2022. The primary effectiveness outcome was freedom from clinical documented atrial arrhythmia (AF/atrial flutter/atrial tachycardia) of ≥30 seconds on the basis of electrocardiographic data after a 3-month blanking period (on or off antiarrhythmic drugs). Safety outcomes included the composite of acute (<7 days postprocedure) and latent (>7 days) major adverse events. RESULTS: At 24 European centers (77 operators) pulsed field ablation was performed in 1568 patients with AF: age 64.5±11.5 years, female 35%, paroxysmal/persistent AF 65%/32%, CHA2DS2-VASc 2.2±1.6, median left ventricular ejection fraction 60%, and left atrial diameter 42 mm. Pulmonary vein isolation was achieved in 99.2% of patients. After a median (interquartile range) follow-up of 367 (289-421) days, the 1-year Kaplan-Meier estimate for freedom from atrial arrhythmia was 78.1% (95% CI, 76.0%-80.0%); clinical effectiveness was more common in patients with paroxysmal AF versus persistent AF (81.6% versus 71.5%; P=0.001). Acute major adverse events occurred in 1.9% of patients. CONCLUSIONS: In this large observational registry of the postapproval clinical use of pulsed field technology to treat AF, catheter ablation using pulsed field energy was clinically effective in 78% of patients with AF.

Very high-power short-duration catheter ablation for treatment of cardiac arrhythmias: Insights from the FAST and FURIOUS study series.

The QDOT MICRO™ Catheter is a novel open-irrigated contact force-sensing radiofrequency ablation catheter. It offers very high-power short-duration (vHPSD) ablation with 90 W for 4 s to improve safety and efficacy of catheter ablation procedures. Although the QDOT MICRO™ Catheter was mainly designed for pulmonary vein isolation (PVI) its versatility to treat atrial fibrillation (AF) and other types of arrhythmias was recently evaluated by the FAST and FURIOUS study series and other studies and will be presented in this article. Available study and registry data as well as case reports concerning utilization of the QDOT MICRO™ Catheter for the treatment of cardiac arrhythmias including AF, focal and macroreentry atrial tachycardia, typical atrial flutter by cavotricuspid isthmus block, premature ventricular contractions, and accessory pathways were reviewed and summarized. In summary, the QDOT MICRO™ Catheter showed safety and efficacy for PVI and is able to treat also other types of arrhythmias as is was recently evaluated by case reports and the FAST and FURIOUS studies.

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.

[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.

Economic Considerations of Cardiovascular Implantable Electronic Devices for The Treatment of Heart Failure.

PURPOSE OF REVIEW: Heart failure (HF) is a major public health problem worldwide, affecting more than 64 million people [1]. The complex and severe nature of HF presents challenges in providing cost-effective care as patients often require multiple hospitalizations and treatments. This review of relevant studies with focus on the last 10 years summarizes the health and economic implications of various HF treatment options in Europe and beyond. Although the main cost drivers in HF treatment are clinical (re)admission and decompensation of HF, an assessment of the economic impacts of various other device therapy options for HF care are included in this review. This includes: cardiovascular implantable electronic devices (CIEDs) such as cardiac-resynchronisation-therapy devices that include pacemaking (CRT-P), cardiac-resynchronisation-therapy devices that include defibrillation (CRT-D), implantable cardioverter/defibrillators (ICDs) and various types of pacemakers. The impact of (semi)automated (tele)monitoring as a relevant factor for increasing both the quality and economic impact of care is also taken into consideration. Quality of life adjusted life years (QALYs) are used in the overall context as a composite metric reflecting quantity and quality of life as a standardized measurement of incremental cost-effectiveness ratios (ICER) of different device-based HF interventions. RECENT FINDINGS: In terms of the total cost of different devices, CRT-Ds were found in several studies to be more expensive than all other devices in regards to runtime and maintenance costs including (re)implantation. In the case of CRT combined with an implantable cardioverter-defibrillator (CRT-D) versus ICD alone, CRT-D was found to be the most cost-effective treatment in research work over the past 10 years. Further comparison between CRT-D vs. CRT-P does not show an economic advantage of CRT-D as a minority of patients require shock therapy. Furthermore, a positive health economic effect and higher survival rate is seen in CRT-P full ventricular stimulation vs. right heart only stimulation. Telemedical care has been found to provide a positive health economic impact for selected patient groups-even reducing patient mortality. For heart failure both in ICD and CRT-D subgroups the given telemonitoring benefit seems to be greater in higher-risk populations with a worse HF prognosis. In patients with HF, all CIED therapies are in the range of commonly accepted cost-effectiveness. QALY and ICER calculations provide a more nuanced understanding of the economic impact these therapies create in the healthcare landscape. For severe cases of HF, CRT-D with telemedical care seems to be the better option from a health economic standpoint, as therapy is more expensive, but costs per QALY range below the commonly accepted threshold.

A worldwide survey on incidence, management, and prognosis of oesophageal fistula formation following atrial fibrillation catheter ablation: the POTTER-AF study.

AIMS: Oesophageal fistula represents a rare but dreadful complication of atrial fibrillation catheter ablation. Data on its incidence, management, and outcome are sparse. METHODS AND RESULTS: This international multicentre registry investigates the characteristics of oesophageal fistulae after treatment of atrial fibrillation by catheter ablation. A total of 553 729 catheter ablation procedures (radiofrequency: 62.9%, cryoballoon: 36.2%, other modalities: 0.9%) were performed, at 214 centres in 35 countries. In 78 centres 138 patients [0.025%, radiofrequency: 0.038%, cryoballoon: 0.0015% (P < 0.0001)] were diagnosed with an oesophageal fistula. Peri-procedural data were available for 118 patients (85.5%). Following catheter ablation, the median time to symptoms and the median time to diagnosis were 18 (7.75, 25; range: 0-60) days and 21 (15, 29.5; range: 2-63) days, respectively. The median time from symptom onset to oesophageal fistula diagnosis was 3 (1, 9; range: 0-42) days. The most common initial symptom was fever (59.3%). The diagnosis was established by chest computed tomography in 80.2% of patients. Oesophageal surgery was performed in 47.4% and direct endoscopic treatment in 19.8% and conservative treatment in 32.8% of patients. The overall mortality was 65.8%. Mortality following surgical (51.9%) or endoscopic treatment (56.5%) was significantly lower as compared to conservative management (89.5%) [odds ratio 7.463 (2.414, 23.072) P < 0.001]. CONCLUSION: Oesophageal fistula after catheter ablation of atrial fibrillation is rare and occurs mostly with the use of radiofrequency energy rather than cryoenergy. Mortality without surgical or endoscopic intervention is exceedingly high.

Acute procedural efficacy and safety of a novel cryoballoon for the treatment of paroxysmal atrial fibrillation: Results from the POLAR ICE study.

INTRODUCTION: Pulmonary vein isolation (PVI) is well established as a primary treatment for atrial fibrillation (AF). The POLAR ICE study was designed to collect prospective real world data on the safety and effectiveness of the POLARxTM cryoballoon for PVI to treat paroxysmal AF. METHODS: POLAR ICE, a prospective, non-randomized, multicenter (international) registry (NCT04250714), enrolled 399 patients across 19 European centers. Procedural characteristics, such as time to isolation, cryoablations per pulmonary vein (PV), balloon nadir temperature, and occlusion grade were recorded. PVI was confirmed with entrance block testing. RESULTS: Data on 372 de novo PVI procedures (n = 2190 ablations) were collected. Complete PVI was achieved in 96.8% of PVs. Procedure and fluoroscopy times were 68.2 ± 24.6 and 15.6 ± 9.6 min, respectively. Left atrial dwell time was 46.6 ± 18.3 min. Grade 3 or 4 occlusion was achieved in 98.2% of PVs reported and 71.2% of PVs isolation required only a single cryoablation. Of 2190 cryoapplications, 83% had a duration of at least 120 s; nadir temperature of these ablations averaged -56.3 ± 6.5°C. There were 6 phrenic nerve palsy events, 2 of which resolved within 3 months of the procedure. CONCLUSION: This real-world usage data on a novel cryoballoon suggests this device is effective, safe, and relatively fast in centers with cryoballoon experience. These data are comparable to prior POLARx reports and in keeping with reported data on other cryoballoons. Future studies should examine the long-term outcomes and the relationship between biophysical parameters and outcomes for this novel cryoballoon.

Radiosurgery for ventricular tachycardia (RAVENTA): interim analysis of a multicenter multiplatform feasibility trial.

BACKGROUND: Single-session cardiac stereotactic radiation therapy (SBRT) has demonstrated promising results for patients with refractory ventricular tachycardia (VT). However, the full safety profile of this novel treatment remains unknown and very limited data from prospective clinical multicenter trials are available. METHODS: The prospective multicenter multiplatform RAVENTA (radiosurgery for ventricular tachycardia) study assesses high-precision image-guided cardiac SBRT with 25 Gy delivered to the VT substrate determined by high-definition endocardial and/or epicardial electrophysiological mapping in patients with refractory VT ineligible for catheter ablation and an implanted cardioverter defibrillator (ICD). Primary endpoint is the feasibility of full-dose application and procedural safety (defined as an incidence of serious [grade ≥ 3] treatment-related complications ≤ 5% within 30 days after therapy). Secondary endpoints comprise VT burden, ICD interventions, treatment-related toxicity, and quality of life. We present the results of a protocol-defined interim analysis. RESULTS: Between 10/2019 and 12/2021, a total of five patients were included at three university medical centers. In all cases, the treatment was carried out without complications. There were no serious potentially treatment-related adverse events and no deterioration of left ventricular ejection fraction upon echocardiography. Three patients had a decrease in VT episodes during follow-up. One patient underwent subsequent catheter ablation for a new VT with different morphology. One patient with local VT recurrence died 6 weeks after treatment in cardiogenic shock. CONCLUSION: The interim analysis of the RAVENTA trial demonstrates early initial feasibility of this new treatment without serious complications within 30 days after treatment in five patients. Recruitment will continue as planned and the study has been expanded to further university medical centers. TRIAL REGISTRATION NUMBER: NCT03867747 (clinicaltrials.gov). Registered March 8, 2019. Study start: October 1, 2019.

Left atrial appendage closure in end-stage renal disease and hemodialysis: Data from a German multicenter registry.

BACKGROUND: Left atrial appendage closure (LAAC) has emerged as an alternative to oral anticoagulation (OAC) for stroke prevention in patients with atrial fibrillation (AF). OAC treatment has been proven feasible in mild-to-moderate chronic kidney disease (CKD). In contrast, the optimal antithrombotic management of AF patients with end-stage renal disease (ESRD) is unknown and LAAC has not been proven in these patients in prospective randomized clinical trials. OBJECTIVES: The objective of this study is to evaluate safety and efficacy of LAAC in patients with ESRD. METHODS: Patients undergoing LAAC were collected in a German multicenter real-world observational registry. A composite endpoint consisting of the occurrence of ischemic stroke/transient ischemic attack, systemic embolism, and/or major clinical bleeding was assessed. Patients with ESRD were compared with propensity score-matched patients without severe CKD. ESRD was defined as a glomerular filtration rate < 15 ml/min/1.73 m2 or chronic hemodialysis treatment. RESULTS: A total of 604 patients were analyzed, including 57 with ESRD and 57 propensity-matched patients. Overall, 596 endocardial and 8 epicardial LAAC procedures were performed. Frequency of major complications was 7.0% (42/604 patients) in the overall cohort, 8.8% (5/57 patients) in patients with ESRD, and 10.5% (6/57 patients) in matched controls (p = 0.75). The estimated event-free survival of the combined endpoint after 500 days was 90.7 ± 4.5% in patients with ESRD and 90.2 ± 5.5% in matched controls (p = 0.33). CONCLUSIONS: LAAC had comparable procedural safety and clinical efficacy in patients with ESRD and patients without severe CKD.

Practical guidance to reduce radiation exposure in electrophysiology applying ultra low-dose protocols: a European Heart Rhythm Association review.

Interventional electrophysiology offers a great variety of treatment options to patients suffering from symptomatic cardiac arrhythmia. Catheter ablation of supraventricular and ventricular tachycardia has globally evolved a cornerstone in modern arrhythmia management. Complex interventional electrophysiological procedures engaging multiple ablation tools have been developed over the past decades. Fluoroscopy enabled interventional electrophysiologist throughout the years to gain profound knowledge on intracardiac anatomy and catheter movement inside the cardiac cavities and hence develop specific ablation approaches. However, the application of X-ray technologies imposes serious health risks to patients and operators. To reduce the use of fluoroscopy during interventional electrophysiological procedures to the possibly lowest degree and to establish an optimal protection of patients and operators in cases of fluoroscopy is the main goal of modern radiation management. The present manuscript gives an overview of possible strategies of fluoroscopy reduction and specific radiation protection strategies.

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.

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.

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.

Electrophysiology lab efficiency comparison between cryoballoon and point-by-point radiofrequency ablation: a German sub-analysis of the FREEZE Cohort study.

BACKGROUND: Pulmonary vein isolation (PVI) is recommended to treat paroxysmal and persistent atrial fibrillation (AF). This analysis aimed to assess the hospital efficiency of single-shot cryoballoon ablation (CBA) and point-by-point radiofrequency ablation (RFA). METHODS: The discrete event simulation used PVI procedure times from the FREEZE Cohort study to establish the electrophysiology (EP) lab occupancy time. 1000 EP lab days were simulated according to an illustrative German hospital, including 3 PVI cases per day using CBA at one site and RFA at the other. RESULTS: The analysis included 1560 CBA patients and 1344 RFA patients from the FREEZE Cohort. Some baseline patients' characteristics were different between groups (age, AF type, and some concomitant diseases), without being statistically associated to ablation procedure time. Mean procedure time was 122.2 ± 39.4 min for CBA and 160.3 ± 53.5 min for RFA (p < 0.0001). RFA was associated with a more than five-fold increase of cumulative overtime compared to CBA over the simulated period (1285 h with RFA and 253 h with CBA). 70.7% of RFA lab days included overtime versus 25.7% for CBA. CBA was associated with more days with an additional hour at the end of the EP lab shift compared to RFA (47.8% vs 11.5% days with one hour left, respectively). CONCLUSION: CBA is faster and more predictable than point-by-point RFA, and enables improvements in EP lab efficiency, including: fewer cumulative overtime hours, more days where overtime is avoided and more days with remaining time for the staff or for any EP lab usage. Clinical trial registration NCT01360008 (first registration 25/05/2011).

Mechanisms of late arrhythmia recurrence after initially successful pulmonary vein isolation in patients with atrial fibrillation.

BACKGROUND: Catheter ablation is an effective treatment for atrial fibrillation (AF,) but arrhythmia recurrence occurs in a relevant number of patients. Mechanisms of late occurring arrhythmias after ablation procedures are not fully understood. We analyzed electrophysiological mechanisms of early and late arrhythmia recurrences in patients who underwent radiofrequency-based catheter ablation of AF. METHODS AND RESULTS: Consecutive patients who underwent repeat ablation procedures after initial pulmonary vein isolation (PVI) for symptomatic arrhythmia recurrence were analyzed. A total of 110 consecutive patients who underwent catheter ablation for paroxysmal (79%) or persistent AF (21%) were included. Forty-seven patients suffered from early arrhythmia recurrence (group #1: 3-24 months), 29 patients from mid-term arrhythmia recurrences (group #2: 2-5 years), and 34 patients from late arrhythmia recurrences (group #3: > 5 years). Electrical PV reconnection was found in 98% in group #1, 72% in group #2 and 56% in group #3 (p < .001). Mode of arrhythmia recurrence was organized tachycardia in 25%, 28%, and 65% of patients in groups #1, #2, and #3 (p = .001), respectively. Patients with late arrhythmia recurrence had more pronounced left atrial low voltage as compared to patients with early arrhythmia recurrence based on two published scoring system. CONCLUSION: Electrical PV reconnection was found in the majority of patients with early AF recurrence after PVI. In patients with late arrhythmia recurrences this mechanism may play an inferior role, with many patients presenting without PV reconnection, but with LA structural alterations. Thus, early and late occurring arrhythmia recurrence after catheter ablation may be the same symptom of different diseases.

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.