[Lead placement in cardiac implantable electronic devices]. / Elektrodenplatzierung in der kardialen Devicetherapie.

The implantation of electrodes for cardiac implantable electronic devices (CIED) requires profound technical understanding and precise execution. The positioning of electrodes in the right ventricle and atrium has significant implications for patient safety and the effectiveness of CIED therapy. Particular focus is given to the distinction between apical and septal stimulation in ventricular positioning. Based on current data, this article provides a practice-oriented guide that leads implanters through the individual steps of electrode positioning. The implantation of electrodes for physiological stimulation (cardiac resynchronization therapy, CRT, and conduction system pacing, CSP) is not addressed in this article.

Association of atrial mechanical dispersion with atrial fibrillation recurrence following catheter ablation: results of the ASTRA-AF pilot study.

AIMS: For patients with symptomatic drug-refractory atrial fibrillation (AF), catheter ablation to achieve rhythm control is an important therapeutic option. The atrial mechanical dispersion measured as standard deviation of the time to peak strain (SD-TPS) is associated with the risk of AF recurrence following catheter ablation. METHODS: The study cohort prospectively enrolled n = 132 consecutive patients with paroxysmal (n = 88) or persistent AF (n = 44) presenting for de novo pulmonary vein isolation (PVI) and followed for 1 year. We related left atrial (LA) volume, LA ejection fraction, SD-TPS, and global longitudinal strain of the left ventricle and clinical variables (sex, age, and type of AF) to AF recurrence. RESULTS: Kaplan-Meier curves showed higher AF recurrence rate with an increase of SD-TPS with the calculated cut-off of 38.6 ms. Uni- and multivariable Cox regression analysis could show that SD-TPS had the highest relevance regarding AF recurrence with a HR of 1.05 (95% CI, 1.01; 1.09, p = 0.01) and HR of 1.05 (95% CI, 1.01; 1.09, p = 0.02) per 10 ms increase. In the additional analyses for the model including the clinical variables age, sex, and type of AF with paroxysmal or persisting AF, SD-TPS did only show a trend and after adjusting for covariates, SD-TPS showed a HR of 1.04 (95% CI, 0.99; 1.09, p = 0.09) per 10 ms increase. CONCLUSION: Atrial mechanical dispersion was associated with recurrent AF.

Safety and efficacy of long-term Sodium Channel Blocker therapy for Early Rhythm Control: The EAST-AFNET 4 trial.

BACKGROUND AND AIMS: Clinical concerns exist about the potential proarrhythmic effects of the sodium channel blockers flecainide and propafenone (SCB) in patients with cardiovascular disease. SCB were used to deliver early rhythm control (ERC) therapy in EAST-AFNET 4. METHODS: We analysed the primary safety outcome (death, stroke, or serious adverse events related to rhythm-control therapy) and primary efficacy outcome (cardiovascular death, stroke and hospitalization for worsening of heart failure or acute coronary syndrome) during SCB-intake for ERC patients (n = 1395) in EAST-AFNET 4. The protocol discouraged flecainide and propafenone in patients with reduced left ventricular ejection fraction and suggested stopping therapy upon QRS prolongation >25% on therapy. RESULTS: Flecainide or propafenone was given to 689 patients (age 69 (8) years; CHA2DS2-VASc 3.2 (1); 177 with heart failure; 41 with prior myocardial infarction, CABG or PCI; 26 with left ventricular hypertrophy >15 mm; median therapy duration 1,153 [237, 1,828] days). The primary efficacy outcome occurred less often in patients treated with SCB (3/100 (99/3,316) patient-years) than in patients who never received SCB (SCBnever 4.9/100 (150/3,083) patient-years, p < 0.001). There were numerically fewer primary safety outcomes in patients receiving SCB (2.9/100 (96/3,359) patient-years) than in SCBnever patients (4.2/100 (135/3,220) patient-years, adjusted p = 0.015). Sinus rhythm at 2 years was similar between groups (SCB 537/610 (88); SCBnever 472/579 (82)). CONCLUSION: Long-term therapy with flecainide or propafenone appeared to be safe in the EAST-AFNET 4 trial to deliver effective ERC therapy, including in selected patients with stable cardiovascular disease such as coronary artery disease and stable heart failure. CLINICAL TRIAL REGISTRATION: ISRCTN04708680, NCT01288352, EudraCT2010-021258-20, www.easttrial.org.

Use of class IC antiarrhythmic drugs in patients with structural heart disease and implantable cardioverter defibrillator.

BACKGROUND: Due to suspected pro-arrhythmic effects and increased mortality associated with class-IC antiarrhythmic drugs (AADs) in previous trials, AAD therapy in structural heart disease (SHD) is mainly restricted to amiodarone. In the presence of diagnostic and therapeutic advancements in cardiovascular medicine, it remains unclear if previous studies adequately reflect contemporary patients. In clinical practice, class-IC-AADs are occasionally used in individual cases, particularly in patients with an implantable cardioverter defibrillator (ICD). METHODS: This study retrospectively investigated outcome in ICD-carriers with SHD in whom class-IC-AADs were used as an individualized therapy due to failure, side effects, or unacceptable risk of alternative therapeutic options. RESULTS: Fifty patients from four tertiary centers were included (median age 48.5 years; 52% female). The most common underlying SHD were dilated (42%) or ischemic cardiomyopathy (26%) (median LVEF = 45%). Indications for AAD were sustained ventricular arrhythmias (VA) (58%), symptomatic premature ventricular contractions (26%), or atrial arrhythmias (16%). Median follow-up was 27.8 months. Freedom from sustained VA was 72%, and freedom from ICD therapy was 80%. In 19 patients (38%), AAD therapy was terminated. The most common reason was insufficient efficacy (n = 8). Pro-arrhythmia was suspected in three patients. Five patients died during follow-up (10.0%), two of cardiovascular cause (4.0%). CONCLUSION: In a multicenter cohort of ICD-carriers with SHD, class-IC-AADs were associated with a low rate of pro-arrhythmic effects or cardiovascular mortality. The majority of patients remained free from sustained VA during a follow-up of > 2 years. Further efforts should be made to evaluate the safety of class-IC-AADs in SHD patients receiving contemporary cardiovascular therapy.

[Perioperative management for cardiovascular implantable electronic devices]. / Perioperatives Management bei der Versorgung mit aktiven Rhythmusimplantaten.

Cardiovascular implantable electronic devices (CIED) are an important part of modern cardiology and careful perioperative planning of these procedures is necessary. All information relevant to the indication, the procedure, and the education of the patient must be available prior to surgery. This provides the basis for appropriate device selection. Preoperative antibiotic prophylaxis and perioperative anticoagulation management are essential to prevent infection. After surgery, postoperative monitoring, telemetric control, and device-based diagnostics are required before discharge. These processes need to be adapted to the increasing trend towards outpatient care. This review summarises perioperative management based on practical considerations.

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.

[Lead extraction in cardiac implantable electronic devices]. / Sondenextraktionen bei implantierbaren kardialen Devices.

Lead extraction due to infection or lead dysfunction has become more important in recent years. Patients with high risk of severe and life-threatening complications should only undergo surgery in experienced centers where appropriate personnel and equipment are available. In this review, different techniques and methods to safely and successfully perform transvenous lead extraction are summarized.

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.

[Venous access routes for cardiac implantable electronic devices]. / Venöse Zugangswege in der kardialen Devicetherapie.

Various venous access routes in the region of the clavicle are available for cardiac device treatment. After many years of choosing access via the subclavian vein, current data explicitly show that lateral approaches such as preparation of the cephalic vein or puncture of the axillary vein are clearly superior in terms of probe durability and risk of complications. This article describes the preparation and performance of the various access techniques and is intended to provide a practical guide for the work in cardiac pacemaker operations. This work continues a series of articles designed for advanced training in specialized rhythmology.

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.

Electrographic flow-guided ablation in redo patients with persistent atrial fibrillation (FLOW-AF): design and rationale.

Background: Electrographic flow (EGF) mapping enables the dynamic detection of functional or active atrial fibrillation (AF) sources outside the pulmonary veins (PVs), and the presence or absence of these sources offers a novel framework for classifying and treating persistent AF patients based on the underlying pathophysiology of their AF disease. Objective: The primary objective of the FLOW-AF trial is to evaluate the reliability of the EGF algorithm technology (Ablamap software) to identify AF sources and guide ablation therapy in patients with persistent AF. Methods: The FLOW-AF trial (NCT04473963) is a prospective, multicenter, randomized clinical study in which patients with persistent or long-standing persistent AF who have failed prior PV isolation (PVI) undergo EGF mapping after confirmation of intact PVI. In total, 85 patients will be enrolled and stratified based on the presence or absence of EGF-identified sources. Patients with an EGF-identified source above the predetermined activity threshold of ≥26.5% will be randomized in a 1:1 fashion to PVI only vs PVI + ablation of EGF-identified extra-PV sources of AF. Results: The primary safety endpoint is freedom from serious adverse events related to the procedure through 7 days following the randomization procedure; and the primary effectiveness endpoint is the successful elimination of significant sources of excitation with the target parameter the activity of the leading source. Conclusions: The FLOW-AF trial is a randomized study designed to evaluate the ability of the EGF mapping algorithm to identify patients with active extra-PV AF sources.

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.

Efficacy and safety in patients treated with a novel radiofrequency balloon: a two centres experience from the AURORA collaboration.

AIMS: A novel irrigated radiofrequency (RF) balloon (RFB) for pulmonary vein (PV) isolation (PVI) was released in selected centres. We pooled the procedural data on efficacy and safety of RFB-PVI from two high volume German centres. METHODS AND RESULTS: Consecutive patients with RFB procedures were enrolled. A 3D electroanatomical left atrial map guided the RFB navigation. Every RF delivery lasted 60 s, and duration was automatically reduced to 20 s for electrodes facing the posterior wall. Procedural data and post-procedural endoscopy data (<48 h) were analysed. Data from 140 patients were collected (57% male, 67 ± 11 years, 57% paroxysmal atrial fibrillation). There were 547 PVs identified, and 99.1% could be isolated using solely the RFB. Single-shot PVI was recorded in 330/547 (60%) PVs. Median time to isolation during the first application was 10 s (IQR 8-13). A total of 2.1 ± 1.8 applications per PV were delivered, with the left superior PV requiring more application compared to other PVs. Median procedure and fluoroscopy time were 77 min (61-99) and 13 min (10-17), respectively. Major safety events were recorded only in the first 25 cases at each centre and included 1/140(0.7%) cardiac tamponade, 1/140(0.7%) phrenic nerve palsy, and 2/140 strokes (1.4%). An oesophageal temperature rise was recorded in 81/547 (15%) PVs, and endoscopy detected oesophageal lesions in 7/85 (8%) patients undergoing endoscopy. CONCLUSION: The RFB showed a high efficacy allowing for fast PVI procedures, and 60% of PVs could be isolated at the first application. Most safety events were recorded during the learning phase. An oesophageal temperature monitoring is suggested: oesophageal lesions were detected in 8% of patients.

Cost-effectiveness of early rhythm control vs. usual care in atrial fibrillation care: an analysis based on data from the EAST-AFNET 4 trial.

AIMS: The randomized, controlled EAST-AFNET 4 trial showed that early rhythm control (ERC) reduces the rate of a composite primary outcome (cardiovascular death, stroke, or hospitalization for worsening heart failure or acute coronary syndrome) by ∼20%. The current study examined the cost-effectiveness of ERC compared to usual care. METHODS AND RESULTS: This within-trial cost-effectiveness analysis was based on data from the German subsample of the EAST-AFNET 4 trial (n = 1664/2789 patients). Over a 6-year time horizon and from a healthcare payer's perspective, ERC was compared to usual care regarding costs (hospitalization and medication) and effects (time to primary outcome; years survived). Incremental cost-effectiveness ratios (ICERs) were calculated. Cost-effectiveness acceptability curves were constructed to visualize uncertainty. Early rhythm control was associated with higher costs [+€1924, 95% CI (-€399, €4246)], resulting in ICERs of €10 638 per additional year without a primary outcome and €22 536 per life year gained. The probability of ERC being cost-effective compared to usual care was ≥95% or ≥80% at a willingness-to-pay value of ≥€55 000 per additional year without a primary outcome or life year gained, respectively. CONCLUSION: From a German healthcare payer's perspective, health benefits of ERC may come at reasonable costs as indicated by the ICER point estimates. Taking statistical uncertainty into account, cost-effectiveness of ERC is highly probable at a willingness-to-pay value of ≥€55 000 per additional life year or year without a primary outcome. Future studies examining the cost-effectiveness of ERC in other countries, subgroups with higher benefit from rhythm control therapy, or cost-effectiveness of different modes of ERC are warranted.