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.

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.

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.

Epicardial access for VT ablation: analysis of two different puncture techniques, incidence of adhesions and complication management.

INTRODUCTION: Pericardial access for ablation of ventricular arrhythmias (VA) can be gained either by an anterior-oriented or inferior-oriented epicardial puncture under fluoroscopical guidance. We retrospectively sought to assess the safety of these two puncture techniques and the incidence of epicardial adhesions and introduce our algorithm for management of pericardial tamponade. METHODS AND RESULTS: In 211 patients (61.4 ± 15.6 years, 179 males; 84.8%) 271 epicardial ablation procedures of VA were performed using either an anterior- or inferior-oriented approach for epicardial access. Puncture-related complications were systematically analyzed. Furthermore, the incidence of adhesions was evaluated during first and repeated procedures. A total of 34/271 (12.5%) major complications occurred and 23/271 (8.5%) were directly related to epicardial puncture. The incidence of puncture-related major complications in the anterior and inferior group was 4/82 (4.9%) and 19/189 (10.1%), respectively. Pericardial tamponade was the most common major complication (15/271; 5.5%). Collateral damages of adjacent structures such as liver, colon, gastric vessels and coronary arteries occurred in 6/189 (3.2%) patients and only within the inferior epicardial access group. Adhesions were documented in 19/211 (9%) patients during the first procedure and in 47.1% if patients had 2 or more procedures involving epicardial access. CONCLUSION: Anterior-oriented epicardial puncture shows an observed association to a reduced incidence of pericardial tamponades and overall puncture-related complications in epicardial ablation of VA. In cases of repeated epicardial access adhesions increase significantly and may lead to ablation failure.

Innovative tools for atrial fibrillation ablation.

INTRODUCTION: Catheter ablation (CA) for atrial fibrillation (AF) is an effective treatment option with encouraging clinical outcome data. Further improvement of catheter technologies is desirable, in particular for patients with persistent and long-standing persistent AF. The aim of this review is to provide an overview of novel ablation tools in AF-ablation. AREAS COVERED: The most widely used ablation tool still is the single-tip catheter for radiofrequency (RF) ablation. Contact-force (CF) catheters and the introduction of individualized ablation protocols may overcome limitations of single-tip RF-based ablation. Furthermore, balloon-based pulmonary vein isolation (PVI) - first and foremost the cryoballoon (CB) - based ablation - moved into the foreground especially for the treatment of paroxysmal AF, because of its ease of use and proven safety. Upcoming RF balloon technologies are also promising. Moreover, new mapping and imaging technologies might help to identify non-PV-triggers in patients with arrhythmia recurrence and may have the potential to enable real-time therapy assessment. EXPERT OPINION: New ablation tools such as CF-sensing catheters or novel balloon-devices could help to overcome the major limitation of PV-reconnection and lead to improved outcomes. Moreover, novel mapping tools to identify extra-PV-triggers may improve ablation success in patients with persistent and long-standing persistent AF.

Impact of Female Sex on Clinical Outcomes in the FIRE AND ICE Trial of Catheter Ablation for Atrial Fibrillation.

BACKGROUND: Data on predictors of long-term clinical outcomes after catheter ablation of atrial fibrillation (AF) are limited. We sought to assess the association of baseline covariates with clinical outcomes in the 750 patients with drug-refractory paroxysmal AF enrolled in FIRE AND ICE. METHODS: In a 2-part analysis, univariate and multivariable Cox regression models were first used to identify baseline patient characteristics predictive of catheter ablation efficacy determined by the clinical end points of (1) atrial arrhythmia recurrence (primary efficacy failure), (2) cardiovascular rehospitalization, and (3) repeat ablation. Propensity score stratification methods were then used to account for differences in baseline characteristics between sexes. RESULTS: Female sex (hazard ratio [HR], 1.37; 95% confidence interval [CI], 1.08-1.73; P=0.010) and prior direct current cardioversion (HR, 1.40; 95% CI, 1.07-1.82; P=0.013) were independently associated with atrial arrhythmia recurrence. Female sex (HR, 1.36; 95% CI, 1.02-1.80; P=0.035) and hypertension (HR, 1.48; 95% CI, 1.09-2.00; P=0.013) independently predicted cardiovascular rehospitalization. A longer history of AF (HR, 1.03; 95% CI, 1.00-1.06; P=0.039) increased the rate of repeat ablation. Women continued to have higher rates of primary efficacy failure and cardiovascular rehospitalization after propensity score adjustment, with adjusted HRs of 1.51 (95% CI, 1.16-2.18; P<0.05) and 1.40 (95% CI, 1.15-2.17; P<0.05), respectively. CONCLUSIONS: After catheter ablation of paroxysmal AF, female sex was associated with an almost 40% increase in the risks of primary efficacy failure and cardiovascular rehospitalization. Primary efficacy failure was also adversely impacted by a history of direct current cardioversion, whereas hypertension had a negative impact on cardiovascular rehospitalization. History of AF was the only predictor of repeat ablation. CLINICAL TRIAL REGISTRATION: URL: https://www.clinicaltrials.gov. Unique identifier: NCT01490814.

Catheter ablation - new developments in robotics.

Catheter ablation has become the curative treatment modality for various arrhythmias. Extending the indications for catheter ablation from simple supraventricular tachycardias to complex arrhythmias such as ventricular tachycardia or atrial fibrillation, the investigator faces prolonged procedure times, fluoroscopy exposure and the need for stable and reproducible catheter movement. Recently, remote-controlled robotic catheter ablation has emerged as a novel ablation concept to meet these requirements. This review describes the two available robotic ablation systems and summarizes their clinical applications and current human experience.