Acute lesion extension following pulmonary vein isolation with two novel single shot devices: Pulsed field ablation versus multielectrode radiofrequency balloon.

INTRODUCTION: Pulsed-field ablation (PFA) and the multielectrode radiofrequency balloon (RFB) are two novel ablation technologies to perform pulmonary vein isolation (PVI). It is currently unknown whether these technologies differ in lesion formation and lesion extent. We compared the acute lesion extent after PVI induced by PFA and RFB by measuring low-voltage area in high-density maps and the release of biomolecules reflecting cardiac injury. METHODS: PVI was performed with a pentaspline catheter (FARAPULSE) applying PFA or with the compliant multielectrode RFB (HELIOSTAR). Before and after PVI high-density mapping with CARTO 3 was performed. In addition, blood samples were taken before transseptal puncture and after post-PVI remapping and serum concentrations of high-sensitive Troponin I were quantified by immunoassay. RESULTS: Sixty patients undergoing PVI by PFA (n = 28, age 69 ± 12 year, 60% males, 39.3% persistent atrial fibrillation [AF]) or RFB (n = 32, age 65 ± 13 year, 53% males, 21.9% persistent AF) were evaluated. Acute PVI was achieved in all patients in both groups. Mean number of PFA pulses was 34.2 ± 4.5 and mean number RFB applications was 8.5 ± 3 per patient. Total posterior ablation area was significantly larger in PFA (20.7 ± 7.7 cm²) than in RFB (7.1 ± 2.09 cm²; p < .001). Accordingly, posterior ablation area for each PV resulted in larger lesions after PFA versus RFB (LSPV 5.2 ± 2.7 vs. 1.9 ± 0.8 cm², LIPV 5.5 ± 2.3 vs. 1.9 ± 0.8 cm², RSPV 4.7 ± 1.9 vs. 1.6 ± 0.5 cm², RIPV 5.3 ± 2.1 vs. 1.6 ± 0.7 cm,² respectively; p < .001). In a subset of 38 patients, increase of hsTropI was higher after PFA (625 ± 138 pg/mL, n = 28) versus RFB (148 ± 36 pg/mL, n = 10; p = .049) supporting the evidence of larger lesion extent by PFA. CONCLUSION: PFA delivers larger acute lesion areas and higher troponin release upon successful PVI than multielectrode RFB-based PVI in this single-center series.

Novel Radiofrequency Balloon Catheter　- Impact of Ablation Parameters on Single-Shot Isolation.

BACKGROUND: A novel multielectrode radiofrequency balloon (RFB) catheter has been released for pulmonary vein isolation (PVI).Methods and Results: In this observational study consecutive patients with drug-refractory paroxysmal or persistent atrial fibrillation (AF) undergoing first-time PVI were enrolled in 2 high-volume ablation centers. All procedures were conducted in conjunction with a 3D-mapping system. Clinical, procedural and ablation parameters were systematically analyzed. 105 patients (58% male; 52% paroxysmal AF, 68±11.3 years mean age, left atrial volume index 38.6±14.8 mL/m2) were included. 241/412 (58.5%) PVs were successfully isolated with a single shot (SS), with a time-to-isolation of 11.6±8 s. Total number of radiofrequency applications was 892 (mean 2.2/PV), resulting in successful isolation of 408/412 (99%) PVs at the end of the procedure. Mean electrodes' impedance drop was significantly higher in the SS-PVI compared with non-SS applications (21.5±6.6 vs. 18.6±6.5 Ohm). Concordantly, higher temperature rise was observed in the SS vs. non-SS applications (10.9±4.9℃ vs. 9.6±4.7℃). CONCLUSIONS: In this multicenter real-world study, mean impedance drop and temperature rise were associated with successful SS-PVI applying the novel RFB catheter. These parameters may help to guide efficient usage of the new RF balloon.

The established and the challenger: A direct comparison of current cryoballoon technologies for pulmonary vein isolation.

INTRODUCTION: Cryoballoon (CB) ablation for pulmonary vein isolation (PVI) is an effective treatment of atrial fibrillation (AF). Recently, a novel cryoablation system was introduced. The aim of the study was to compare the safety, efficacy and biophysical characteristics of a novel cryoablation system (POLARx™; Boston Scientific) to a commonly used and clinically well characterized system (Arctic Front Advance Pro™, AFA; Medtronic). METHODS AND RESULTS: Fifty consecutive patients with symptomatic AF, who underwent CB-based ablation with the POLARx were compared to 50 consecutive patients treated with the AFA. Acute PVI was achieved in 99.8% (POLARx 99.5%, AFA 100%, p = 1.00). Time to isolation (TTI) was comparable in both groups (POLARx 35 [27, 48] s, AFA 30 [21, 43] s, p = 0.165). The POLARx showed a lower balloon temperature at TTI (POLARx -44 [-50, -36] °C, AFA -31 [-38, -21] °C, p < 0.001) and lower nadir temperature (POLARx -60 [-65, -55] °C, AFA -48 [-54, -45] °C, p < 0.001). Procedure time (POLARx 80 [60, 105] min, AFA 62 [42, 80] min, p < 0.001), fluoroscopy time (POLARx 17 [13, 22] min, AFA 11 [7, 16] min, p < 0.001) and freeze cycles per patient (POLARx 5 [4, 6], AFA 4.5 [4, 5], p = 0.002) were higher in the POLARx group. Two cerebral ischemic events occurred in the POLARx group, two patients in each group had phrenic nerve injury. CONCLUSION: Both systems enable effective isolation of pulmonary veins. The POLARx required longer procedure and fluoroscopy times. Larger, prospective and randomized studies are needed to assess long-term efficacy and safety of this technology.

Novel cryoballoon ablation system for pulmonary vein isolation: multicenter assessment of efficacy and safety-ANTARCTICA study.

AIMS: Pulmonary vein isolation (PVI) either by balloon devices or radiofrequency forms the cornerstone of invasive atrial fibrillation (AF) treatment. Although equally effective cryoballoon (CB)-based PVI offers shorter procedure duration and a better safety profile. Beside the worldwide established Arctic Front Advance system, a novel CB device, POLARx, was recently introduced. This CB incorporates unique features, which may translate into improved efficacy and safety. However, multicentre assessment of periprocedural efficacy and safety is lacking up to date. METHODS AND RESULTS: A total of 317 patients with paroxysmal or persistent AF were included and underwent POLARx CB-based PVI in 6 centres from Germany and Italy. Acute efficacy and safety were assessed in this prospective multicenter observational study. In 317 patients [mean age: 64 ± 12 years, 209 of 317 (66%) paroxysmal AF], a total of 1256 pulmonary veins (PVs) were identified and 1252 (99,7%) PVs were successfully isolated utilizing mainly the short tip POLARx CB (82%). The mean minimal CB temperature was -57.9 ± 7°C. Real-time PVI was registered in 72% of PVs. The rate of serious adverse events was 6.0% which was significantly reduced after a learning curve of 25 cases (9.3% vs. 3.0%, P = 0.018). The rate of recurrence-free survival after mean follow-up of 226 ± 115 days including a 90-day blanking period was 86.1%. CONCLUSION: In this large multicentre assessment, the novel POLARx CB shows a promising efficacy and safety profile after a short learning curve.

Revival of the Forgotten.

Pulmonary vein (PV) isolation (PVI) by continuous, transmural and durable lesions is decisive for ensuring long-term freedom from atrial fibrillation (AF). AF ablation requires irrigated tip catheters to reduce thromboembolic complications. This precluded temperature-controlled delivery of radiofrequency (RF) energy.The aim of this study was to evaluate feasibility, acute efficacy, and safety of an irrigated, temperature-controlled ablation catheter [DiamondTemp™ (DT) Medtronic®] for PVI.Consecutive patients with AF underwent PVI using the DT catheter combined with high-power short-duration RF applications. Ablation settings were (1) a catheter tip temperature limit of 60°C, (2) a temperature-controlled power of 50 W, and (3) application duration of 10 seconds. The primary endpoint was acute isolation of PVs, reassessed after a 30-minute waiting period. Secondary endpoints included procedural parameters (defined as a catheter tip temperature of 50°C > 3 seconds, an impedance drop of 5-10 Ω) and the occurrence of serious adverse events.Fifty consecutive patients [mean age 66 ± 12 years, 38 (76%) women, 24 patients with paroxysmal AF (48%)] were included. Median procedure and left atrial dwell time was 89 [68; 107] and 63 [52; 79] minutes, respectively. Mean number of RF applications was 59 ± 20, and mean total RF duration was 14 ± 6 minutes. Acute PVI was achieved in all patients solely using DT ablation. Acute PV reconnection within the waiting period occurred in five patients; all reconnected PVs were successfully reisolated. One major complication occurred.In this study, the DT ablation system demonstrated high acute efficacy for PVI. Temperature-controlled ablation in conjunction with high-power short-duration applications might be effectively supported.

[Sexual abuse of care-dependent patients : Results of a nationwide cross-sectional study among general practitioners on responsibility and subjective confidence in dealing with suspected abuse]. / Sexueller Missbrauch Pflegebedürftiger : Ergebnisse einer bundesweiten Querschnittsstudie bei Hausärzten/-ärztinnen zu Verantwortung und subjektiven Sicherheit im Verdachtsfall.

BACKGROUND: Violence against people in need of care is a challenge for long-term care situations. Sexual violence in particular, is subject to strong taboos and has so far been little researched. Family physicians can play a role in preventing violence against people in need of care. OBJECTIVE: The objective of this study was to examine family physicians' attitudes to their responsibilities in cases of sexual abuse of patients in need of care. At the same time, we also examined subjective confidence in relation to the procedure in cases of suspected abuse and family physicians' interests in further training on this topic. MATERIAL AND METHODS: A cross-sectional study addressed to 1700 family physicians in Germany with a written survey between September and November 2016. Questionnaires from 302 physicians could be evaluated for the study. FINDINGS: Almost all respondents saw it as part of their responsibility as doctors to intervene in cases of sexual abuse of patients in need of care. There is great uncertainty about how to proceed in cases of suspected sexual abuse of patients in need of care. Respondents' main interest in further training related to the differential diagnosis of sexual abuse and the correct procedure in cases where abuse is suspected. CONCLUSION: Further training provision, particularly on the signs of sexual abuse of people in need of care, could contribute to increasing family physicians' confidence to act.

Global multielectrode contact-mapping plus ablation with a single catheter in patients with atrial fibrillation: Global AF study.

INTRODUCTION: The critical question for technological advancement of catheter ablation of atrial fibrillation (AF) is whether a creative new concept can combine and even improve the options of single-tip catheters with the simplicity of the use of balloon catheters. Herein are described the results from the first clinical study of a new multielectrode contact-mapping plus ablation array (Globe) offering such a complete solution. METHODS AND RESULTS: The multielectrode Globe array consists of 16 flat ribs with 122 gold-plated electrodes. Each electrode can record electrograms, ablate, pace, and can measure tissue contact and temperature. Single-shot pulmonary vein isolation (PVI) is possible with temperature-guided ablation of up to 24 electrodes simultaneously with automatic, individual power control of every electrode. Sixty patients with symptomatic AF underwent PVI using the Globe. In all sixty patients, acute PVI was achieved in 232 of 234 attempted PVs (99.1%). In 34 patients treated with "single-hot-shot" ablation, PVI was achieved in 136 of 136 PVs (100%). Single-procedure 12-month freedom from AF off antiarrhythmic drugs in the "single-hot-shot" group was 75.5% and freedom from AF/atrial tachycardia 72.3%. In two patients, pericardial tamponade was observed, one after a transseptal puncture, and one during array insertion with an over-advanced sheath. There were no other device-related serious adverse events, including stroke, PV stenosis, esophageal perforation, or phrenic nerve palsy. CONCLUSIONS: In this first clinical series, the Globe catheter was found to be an easy-to-use system for single-shot PVI. The continuously updated multielectrode voltage and activation mapping data indicate future options for mapping and ablation beyond PVI.

Dementia-specific drug treatment in home care settings: A German multicentre study.

AIMS AND OBJECTIVES: The aim of this study was to identify and analyse factors influencing the use of drugs for dementia treatment in home care settings. BACKGROUND: While the number of care-dependent people with dementia is growing, it is not clear whether their medication follows the state of the art, especially in home care settings where over two-thirds of them are cared for in Germany. Although dementia is not curable, it is possible to reduce cognitive, behavioural and psychological symptoms of dementia with the appropriate use of medication. However, there is a lack of information concerning the drug treatment in home care settings. METHODS: The study was conducted as a multicentre cross-sectional survey, including 923 participants from 102 home care institutions throughout Germany. Medical diagnosis, medication, consultations with a specialist within the previous 12 weeks of the initial assessment and additional general information were assessed following a standardised study protocol. Data were analysed using univariate and multivariate statistical methods. The manuscript was developed utilising the STROBE checklist for cross-sectional studies. RESULTS: In home care, one in seven clients (14.8%) is diagnosed with some form of dementia. 52.6% (n = 72) of them were treated with dementia medication: AchEIs 16.1% (n = 22), memantine 9.5% (n = 13), antidepressants 23.4% (n = 32), antipsychotic medication 9.5% (n = 13), tranquilisers 16.8% (n = 23) and anticonvulsant drugs 6.6% (n = 9). Drug treatment for dementia was significantly associated with the consultation of a neurologist/psychiatrist in the previous 12 weeks. CONCLUSIONS: It has been demonstrated that the use of drugs as a component of home care treatment for dementia depends on many factors and therefore varies. RELEVANCE TO CLINICAL PRACTICE: It can be assumed that people living with dementia in home care settings are not sufficiently supplied with medication. Their medical care can be improved by establishing interdisciplinary care involving a neurologist/psychiatrist.

A novel ablation approach in atrial fibrillation patients undergoing fibrotic-based substrate modification: Targeting the Bachmann's bundle?

INTRODUCTION: Box isolation of fibrotic areas (BIFA) is a promising ablation approach for atrial fibrillation (AF) patients. However, complete isolation of fibrotic anteroseptal left atrial area, where Bachmann's bundle is blending into the left atrial myocardium, is very specific and complex. METHODS AND RESULTS: In 34 AF patients with anteroseptal fibrosis, circumferential BIFA was performed in addition to pulmonary vein isolation. In 8 of 34 patients, complete isolation of the fibrotic area was achieved with BIFA alone. In 26 of 34 patients, a decrease in voltage amplitude with or without conduction delay was observed after box ablation but no complete isolation. Activation mapping and characteristic unipolar potentials revealed earliest activation inside the box from one (73%), two (15%), or three (12%) remaining inputs, in the region of Bachmann's bundle insertion. Focal ablation inside the box (mean radiofrequency impulses: 1.7 ± 0.4, mean radiofrequency time: 70 ± 19 seconds) led to complete isolation of the fibrotic area in 25 of 26 patients. Overall, 97% of anteroseptal boxes were completely isolated with additional focal ablation in the study group compared to 21% in the control group with BIFA alone (33/34 vs. 7/34, P < 0.001). Time of left atrial activation decreased significantly by 25% after complete box isolation (P < 0.001). After a single procedure, 12-month arrhythmia-free survival was 82% with additional focal ablation compared to 71% in the control group (P = 0.2). CONCLUSION: Targeted and focal ablation in the region of Bachmann's bundle is a novel and feasible technique to achieve complete isolation of the left atrial anteroseptal fibrotic area.

Catheter ablation of atrial fibrillation with box isolation of fibrotic areas: Lessons on fibrosis distribution and extent, clinical characteristics, and their impact on long-term outcome.

INTRODUCTION: The BIFA concept (box isolation of fibrotic areas) supplementing pulmonary vein isolation (PVI) was implemented in atrial fibrillation (AF) patients with fibrotic atrial cardiomyopathy (FACM) to improve catheter ablation outcomes. METHODS AND RESULTS: Ninety-two patients with FACM underwent PVI + BIFA. We investigated patient characteristics (58 persistent/34 paroxysmal, 68 ± 8 years, LA 44 ± 7 mm, CHA2 DS2 -VASc 2.6 ± 1.3, FACM I: 15.2%, II: 53.3%, III: 26.1%, IV: 5.4%), periprocedural data concerning fibrosis extent/distribution, and their impact on outcome. Based on severe fibrosis areas (SFAs) of 13.5 ± 13.9 cm2 detected by voltage mapping, 1.4 ± 0.5 boxes (n = 1-3, 2.2-35.3 cm2 ) were applied in the left atrium. With higher grade FACM, SFAs increased and maximum voltage decreased (I/IV: 6.29/3.18 mV). Anterior (ant.) SFAs were found to be more common and larger than posterior (post.) SFAs (58.3% vs. 42.6%, ant. 8.0 ± 8.0 vs. post. 4.7 ± 6.8 cm2 ). In 40 of 92 (43%) patients, both atrial walls were affected with rare cases of solely post. fibrosis (6 of 92, 6.6%). Women (39 of 92, 42%) showed FACM III+IV more often than men (P = 0.022) and can still present paroxysmal while persistent males are more likely to have FACM I-II. Single and multiple procedure (1.2/patient) success was 69% and 83% after 16 ± 8 months with an unfavorable impact of large SFA size, both-sided fibrosis and reduced maximum voltage, independently of patient characteristics and AF type. CONCLUSION: FACM patients are a challenging AF subgroup for catheter ablation. Women seem to show FACM III+IV more often than men. The distribution of left atrial fibrosis is variable but more pronounced anteriorly. Atrial disease is characterized by SFA size but also maximum voltage reduction, both with implications on ablation outcome. Using BIFA, success rates of patients without fibrosis can be approached but are limited in FACM III+IV.

Global multielectrode contact mapping plus ablation with a single catheter: Preclinical and preliminary experience in humans with atrial fibrillation.

INTRODUCTION: One question for the technological advancement of catheter ablation of atrial fibrillation (AF) is whether a creative new concept can combine and even improve the diagnostic mapping options of single-tip and basket catheters with the simplicity of the use of balloon catheters for ablation. Herein, we describe the first in-human experience with a single catheter offering such a complete solution. METHODS AND RESULTS: A new catheter (Globe® ) with a distal multielectrode array consisting of 16 ribs with 122 gold-plated electrodes was used. Each electrode can ablate, pace, and can measure tissue contact, temperature, current, and intracardiac electrograms. The Globe was deployed and removed without difficulty in all 3 patients. Complete pulmonary vein isolation (PVI) was achieved in all 12 veins. In 10 veins, PVI was achieved with a single placement in front of the respective vein ("single circle isolation"). In one subject, the device was repositioned due to the esophagus location. In the other subject, a single gap was observed after circumferential ablation of the right inferior PV. After precise gap identification, the device was adjusted slightly for improved contact at that region, and reablation resulted in immediate PVI. CONCLUSIONS: PVI isolation could be performed with the new multielectrode array Globe in all 12 PVs offering the option for easy handling and fast "single-shot" PVI. Several continuously updated mapping types from 122 electrodes even in real time during ablation demonstrate the capability to go beyond PVI for voltage mapping plus substrate modification, and for rotor mapping plus rotor ablation.

Global health education in Germany: an analysis of current capacity, needs and barriers.

BACKGROUND: In times of increasing global challenges to health, it is crucial to create a workforce capable of tackling these complex issues. Even though a lack of GHE in Germany is perceived by multiple stakeholders, no systematic analysis of the current landscape exists. The aim of this study is to provide an analysis of the global health education (GHE) capacity in Germany as well as to identify gaps, barriers and future strategies. METHODS: An online search in combination with information provided by student representatives, course coordinators and lecturers was used to create an overview of the current GHE landscape in Germany. Additionally, a semi-structured questionnaire was sent to GHE educators and students engaged in global health (GH) to assess the capacity of German GHE, its barriers and suggested strategies for the future. RESULTS: A total of 33 GHE activities were identified at 18 German universities. Even though medical schools are the main provider of GHE (42%), out of 38 medical schools, only 13 (34%) offer any kind of GHE. Modules offered for students of other health-related professions constitute 27% of all activities. Most survey respondents (92%, n = 48) consider current GHE activities in Germany insufficient. Suggested formats were GHE as part of medical curricula (82%, n = 45) and dual degree MD/MPH or PhD programs. Most important barriers mentioned were low priority of GH at faculties and academic management levels (n = 41, 75%) as well as lack of necessary institutional structures (n = 33, 60%). CONCLUSIONS: Despite some innovative academic approaches, there is clearly a need for more systematic GHE in Germany. GHE educators and students can take an important role advocating for more awareness at university management level and suggesting ways to institutionalize GHE to overcome barriers. This study provides key evidence, relevant perceptions and suggestions to strengthen GHE in Germany.

T-wave variability for the prediction of fast ventricular arrhythmias ­ prospective, observer-blind study.

BACKGROUND: The clinical value of T-wave variability (T-var) for ventricular arrhythmia (VA) risk prediction was evaluated. METHODS AND RESULTS: Three 20-min Holter-ECG-based T-var measurements (I1 at baseline, I2 after 6.5 ± 1.6 months and I3 after 13.1 ± 2.0 months) were done in 121 patients. T-var was defined as the amplitude variability of the T-wave with the maximum of T-wave oscillation. The endpoint was a fast, potentially fatal VA (>240 beats/min). During follow-up (20 ± 4 months) 20/121 patients (55% ischemic heart disease, 15% preserved left ventricular ejection fraction [LVEF]) had fast VA terminated by ICD or external shock. Although T-var did not differ between patients with vs. without fast VA at baseline (I1: 10.7 ± 7.3 µV vs. 7.8 ± 4.1 µV, P=0.170), patients with fast VA had higher T-var compared to those without fast VA at 2 subsequent measurements (I2: 14.0 ± 6.5 µV vs. 8.2 ± 3.6 µV, P=0.030; I3: 17.0 ± 5.4 µV vs. 8.8 ± 4.6 µV, P=0.004). The increase in T-var between I1 and I2 was higher in patients with fast VA (∆T-var=7.0 ± 9.3 µV), as compared to patients without (∆T-var=0.4 ± 4.3 µV). After adjustment for LVEF in a multiple logistic regression model, the odds ratio for developing fast VA was 1.1 (P=0.056) for each 1-µV increment in T-var at I1. CONCLUSIONS: T-var is elevated in patients with fast VA, and both elevation of T-var and increase in T-var may complement LVEF in VA risk stratification.

Primary preventive cardioverter-defibrillator implantation (Pro-ICD) in patients awaiting heart transplantation. A prospective, randomized, controlled 12-year follow-up study.

The aim of this study was to evaluate whether short-term primary preventive cardioverter-defibrillator (ICD) implantation as bridge to heart transplantation (HTX) provides any survival benefit. Thirty-three patients awaiting HTX were randomized to either conventional therapy (control group) or primary preventive ICD implantation (ICD group). Fourteen patients had ischemic cardiomyopathy (ICM) and 19 patients had dilated cardiomyopathy (DCM). Sixteen patients were randomized to the ICD group and 17 patients were randomized to the control group. Twenty patients (61%) were transplanted after a waiting time of 10 ± 9 months. The remaining 13 patients (39%) were not transplanted because of clinical improvement (n = 5), cerebral hemorrhage (n = 3), or death (n = 5). On the waiting list, 3 ICD patients with DCM developed slow VTs without ICD intervention, two patients with ICM (6%) had fast VT terminated by the ICD, and no arrhythmic death was observed. After 11.9 years (median), 13 of 20 HTX patients (65%) and 5 of 13 non-HTX patients (38%) were alive. Survivors had a higher LVEF (22 ± 6 vs. 17 ± 4%, P = 0.0092) and a better exercise capacity (75 ± 29 vs. 57 ± 24 Watt, P = 0.0566) at baseline as compared to nonsurvivors. This study may not support the general use of primary preventive ICDs as a short-term bridge to heart transplantation.

Repeat pulmonary vein isolation and anterior line ablation using a novel point-by-point pulsed-field ablation system.

BACKGROUND: Pulsed-field ablation (PFA) is a nonthermal energy source for ablation of cardiac arrhythmias. This study investigated the prospective outcomes of a novel PFA generator in conjunction with a commercially available, contact force-sensing, focal ablation catheter. OBJECTIVE: The purpose of this study was to assess the feasibility, safety, and lesion characteristics of point-by-point PFA in consecutive patients undergoing repeat ablation of atrial fibrillation (AF). METHODS: The study involved reisolation of pulmonary veins (PVs) with electrical reconnection and the creation of an anterior line (AL) in patients with anterior substrate or durable pulmonary vein isolation (PVI). RESULTS: In 24 patients (46% female; mean age 67 ± 10 years; 67% persistent AF), successful reisolation of 27 of 27 reconnected PVs (100%) was performed. In 19 patients, AL ablation was performed, with bidirectional block in 16 (84%), median ablation time 26 [21, 33] minutes, and first-pass bidirectional block in 13 patients (68%). Acute AL reconduction occurred in 8 of 19 patients (42%). Among these 8 patients, a subsequent sustained block of the AL was achieved in 5 (63%). Ultra-high-density electroanatomic mapping revealed homogeneous but relatively large low-voltage areas in the ablated regions. Median procedural, left atrial dwell, and fluoroscopy times were 100 [90, 109] minutes, 83 [75, 98] minutes, and 10 [8, 13] minutes, respectively. No major or minor complications occurred. CONCLUSION: This study demonstrated feasibility, acute efficacy, and safety of point-by-point PFA for repeat PVI and AL ablation. Further studies are warranted to assess the long-term durability and comparison with established ablation methods.

Management of pericardial tamponade in the electrophysiology laboratory: results from a national survey.

BACKGROUND: Despite continued efforts to improve the safety of catheter ablation, pericardial tamponade remains one of its more frequent, potentially life-threatening complications. Management of cardiac tamponade is not standardized and uncertainties regarding acute treatment remain. METHODS: This survey sought to evaluate the management of cardiac tamponade in German EP centers via a standardized postal questionnaire. All 341 identified German EP centers were invited to return a questionnaire on their standards for the management of cardiac tamponade. RESULTS: A total of 189 German EP centers completed the questionnaire. Several precautions are followed to avoid pericardial tamponade: A minority of centers preclude very old patients (19%) or those with a high body mass index (30%) from ablation. Non-vitamin K antagonist oral anticoagulants are briefly paused in most centers (88%) before procedures, while vitamin K antagonists are continued. Pericardial tamponade is usually treated using reversal of heparin by applying protamine (86%) and pericardiocentesis under both, fluoroscopic and echocardiographic guidance (62%). A pigtail catheter is mostly inserted (97%) and autotransfusion of aspirated blood is performed in 47% of centers. The decision for surgical repair depends on different clinical and infrastructural aspects. The timing of reinitiation of anticoagulation widely differs between the centers. Approximately 1/3 of centers prescribe nonsteroidal anti-inflammatory agents, colchicine or steroids after pericardiocentesis. CONCLUSION: The present survey shows that the management of cardiac tamponade is still inhomogeneous in German ablation centers. However, multiple findings of this survey can be generalized and might guide especially less experienced operators and centers in their treatment and decision strategies.

The infrastructure of electrophysiology centers impacts the management of cardiac tamponade-Results from a national survey.

BACKGROUND: Although electrophysiological (EP) centers have institutional standards, evidence on management of cardiac tamponade is lacking. AIM AND METHODS: A physician-based survey was conducted by sending out questionnaires to all hospitals in Germany performing EP procedures. To evaluate the infrastructure of EP centers and the impact of center volume and onsite cardiac surgery on the management of cardiac tamponade, the results of the survey were analyzed for low-volume (0-250 procedures per year), mid-volume (250-500 procedures), and high-volume (>500 procedures) centers, as well as for centers with and without onsite cardiac surgery. RESULTS: A total of 341 centers were identified and 189/341 (55%) returned data sets were analyzed. Most types of EP procedures are performed across all kinds of centers. Ablation of ventricular tachycardia (VT) is concentrated in higher volume centers and in centers with onsite cardiac surgery. None of the participating low-volume centers and only 13% of centers without onsite cardiac surgery responded to performing epicardial VT ablation. Irrespective of center volume and onsite cardiac surgery, neither body mass index nor age was reported to be an exclusion criterion for ablation procedures. Higher volume centers and centers with onsite cardiac surgery more often have dedicated EP laboratories and EP-nursing teams. Also, differences regarding periprocedural safety precautions and management of cardiac tamponade were found for low-, mid-, and high-volume centers, as well as for centers with and without onsite cardiac surgery. CONCLUSION: While center volume and onsite cardiac surgery do not impact patient selection, there are differences in ablation spectrum, infrastructure, periprocedural safety precautions, and treatment of tamponade.

A novel saline-based occlusion tool allows for dye-less cryoballoon-based pulmonary vein isolation and fluoroscopy reduction.

Background: Cryoballoon (CB)- based pulmonary vein isolation (PVI) remains guided by fluoroscopy and dye. The novel saline injection-based occlusion tool allows for pulmonary vein (PV)-occlusion assessment without the need for dye injection. Aim: To compare KODEX-EPD guided CB-PVI using the novel saline injection-based workflow with conventional cryoablation for acute efficacy, fluoroscopy exposure and dye volume. Methods: Consecutive atrial fibrillation (AF)- patients undergoing CB-PVI in conjunction with KODEX-EPD (CryoEPD group) were analyzed. Patients undergoing conventional CB-PVI (Cryo group) in the same time period acted as controls. Results: One hundred forty patients [91/140 (65%) persistent AF] were studied. Seventy patients underwent CryoEPD procedures [64 ± 13 years, 21 (30%) female] and seventy patients underwent Cryo procedures [68 ± 10 years, 27 (39%) female].A total of 560 PVs were identified and successfully isolated. Mean procedure time was 66 ± 15 min for the CryoEPD group, and 65 ± 19 min for the Cryo group (p = 0.3). Fluoroscopy time (CryoEPD 6 ± 4 min; Cryo 13 ± 6 min, p < 0.001) and dose area product (CryoEPD 193 [111; 297] cGycm2; Cryo 381 [268; 614] cGycm2, p < 0.001) were lower in patients undergoing CryoEPD compared with Cryo procedures. No dye was needed in the CryoEPD group while 53 ± 18 ml dye per patient were administered for the Cryo group (p < 0.001). The overall complication rate was comparable between both groups (p = 0.5). Conclusion: KODEX-EPD guided AF-ablation enables dye-free CB-based PVI with reduced fluoroscopy exposure when compared to conventional CB-ablation, without differences in acute procedural outcomes or procedure duration.

Pulsed-field ablation-based pulmonary vein isolation: acute safety, efficacy and short-term follow-up in a multi-center real world scenario.

PURPOSE: Pulsed-field ablation (PFA) is a new energy source to achieve pulmonary vein isolation (PVI) by targeted electroporation of cardiomyocytes. Experimental and controlled clinical trial data suggest good efficacy of PFA-based PVI. We aimed to assess efficacy, safety and follow-up of PFA-based PVI in an early adopter routine care setting. METHODS: Consecutive patients with symptomatic paroxysmal or persistent atrial fibrillation (AF) underwent PVI using the Farawave® PFA ablation catheter in conjunction with three-dimensional mapping at two German high-volume ablation centers. PVI was achieved by applying 8 PFA applications in each PV. RESULTS: A total of 138 patients undergoing a first PVI (67 ± 12 years, 66% male, 62% persistent AF) were treated. PVI was achieved in all patients by deploying 4563 applications in 546 PVs (8.4 ± 1.0/PV). Disappearance of PV signals after the first application was demonstrated in 544/546 PVs (99.6%). More than eight PFA applications were performed in 29/546 PVs (6%) following adapted catheter positioning or due to reconnection as assessed during remapping. Mean procedure time was 78 ± 22 min including pre- and post PVI high-density voltage mapping. PFA catheter LA dwell-time was 23 ± 9 min. Total fluoroscopy time and dose area product were 16 ± 7 min and 505 [275;747] cGy*cm2. One pericardial tamponade (0.7%), one transient ST-elevation (0.7%) and three groin complications (2.2%) occurred. 1-year follow-up showed freedom of arrhythmia in 90% in patients with paroxysmal AF (n = 47) and 60% in patients with persistent AF (n = 82, p = 0.015). CONCLUSIONS: PFA-based PVI is acutely highly effective and associated with a beneficial safety and low recurrence rate.