Impact of Access Site on Periprocedural Bleeding and Cerebral and Coronary Events in High-Bleeding-Risk Percutaneous Coronary Intervention: Findings from the RIVA-PCI Trial.

INTRODUCTION: The preference for using transradial access (TRA) over transfemoral access (TFA) in patients requiring percutaneous coronary intervention (PCI) is based on evidence suggesting that TRA is associated with less bleeding and fewer vascular complications, shorter hospital stays, improved quality of life, and a potential beneficial effect on mortality. We have limited study data comparing the two access routes in a patient population with atrial fibrillation (AF) undergoing PCI, who have a particular increased risk of bleeding, while AF itself is associated with an increased risk of thromboembolism. METHODS: Using data from the RIVA-PCI registry, which includes patients with AF undergoing PCI, we analyzed a high-bleeding-risk (HBR) cohort. These patients were predominantly on oral anticoagulants (OAC) for AF, and the PCI was performed via radial or femoral access. Endpoints examined were in-hospital bleeding (BARC 2-5), cerebral events (TIA, hemorrhagic or ischemic stroke) and coronary events (stent thrombosis and myocardial infarction). RESULTS: Out of 1636 patients, 854 (52.2%) underwent TFA, while 782 (47.8%) underwent the procedure via TRA, including nine patients with brachial artery puncture. The mean age was 75.5 years. Groups were similar in terms of age, sex distribution, AF type, cardiovascular history, risk factors, and comorbidities, except for a higher incidence of previous bypass surgeries, heart failure, hyperlipidemia, and chronic kidney disease (CKD) with a glomerular filtration rate (GFR) < 60 ml/min in the TFA group. No clinically relevant differences in antithrombotic therapy and combinations were present at the time of PCI. However, upon discharge, transradial PCI patients had a higher rate of triple therapy, while dual therapy was preferred after transfemoral procedures. Radial access was more frequently chosen for non-ST-segment elevation myocardial infarction (NSTEMI) and unstable angina pectoris (UAP) cases (NSTEMI 26.6% vs. 17.0%, p < 0.0001; UAP 21.5% vs. 14.5%, p < 0.001), while femoral access was more common for elective PCI (60.3% vs. 44.1%, p < 0.0001). No differences were observed for ST-segment elevation myocardial infarction (STEMI). Both groups had similar rates of cerebral events (TFA 0.2% vs. TRA 0.3%, p = 0.93), but the TFA group had a higher incidence of bleeding (BARC 2-5) (4.2% vs. 1.5%, p < 0.01), mainly driven by BARC 3 bleeding (1.5% vs. 0.4%, p < 0.05). No significant differences were found for stent thrombosis and myocardial infarction (TFA 0.2% vs. TRA 0.3%, p = 0.93; TFA 0.4% vs. TRA 0.1%, p = 0.36). CONCLUSIONS: In HBR patients with AF undergoing PCI for acute or chronic coronary syndrome, the use of TRA might be associated with a decrease in in-hospital bleeding, while not increasing the risk of embolic or ischemic events compared to femoral access. Further studies are required to confirm these preliminary findings.

Anticoagulation with Edoxaban in Patients with Atrial High-Rate Episodes.

BACKGROUND: Device-detected atrial high-rate episodes (AHREs) are atrial arrhythmias detected by implanted cardiac devices. AHREs resemble atrial fibrillation but are rare and brief. Whether the occurrence of AHREs in patients without atrial fibrillation (as documented on a conventional electrocardiogram [ECG]) justifies the initiation of anticoagulants is not known. METHODS: We conducted an event-driven, double-blind, double-dummy, randomized trial involving patients 65 years of age or older who had AHREs lasting for at least 6 minutes and who had at least one additional risk factor for stroke. Patients were randomly assigned in a 1:1 ratio to receive edoxaban or placebo. The primary efficacy outcome was a composite of cardiovascular death, stroke, or systemic embolism, evaluated in a time-to-event analysis. The safety outcome was a composite of death from any cause or major bleeding. RESULTS: The analysis population consisted of 2536 patients (1270 in the edoxaban group and 1266 in the placebo group). The mean age was 78 years, 37.4% were women, and the median duration of AHREs was 2.8 hours. The trial was terminated early, at a median follow-up of 21 months, on the basis of safety concerns and the results of an independent, informal assessment of futility for the efficacy of edoxaban; at termination, the planned enrollment had been completed. A primary efficacy outcome event occurred in 83 patients (3.2% per patient-year) in the edoxaban group and in 101 patients (4.0% per patient-year) in the placebo group (hazard ratio, 0.81; 95% confidence interval [CI], 0.60 to 1.08; P = 0.15). The incidence of stroke was approximately 1% per patient-year in both groups. A safety outcome event occurred in 149 patients (5.9% per patient-year) in the edoxaban group and in 114 patients (4.5% per patient-year) in the placebo group (hazard ratio, 1.31; 95% CI, 1.02 to 1.67; P = 0.03). ECG-diagnosed atrial fibrillation developed in 462 of 2536 patients (18.2% total, 8.7% per patient-year). CONCLUSIONS: Among patients with AHREs detected by implantable devices, anticoagulation with edoxaban did not significantly reduce the incidence of a composite of cardiovascular death, stroke, or systemic embolism as compared with placebo, but it led to a higher incidence of a composite of death or major bleeding. The incidence of stroke was low in both groups. (Funded by the German Center for Cardiovascular Research and others; NOAH-AFNET 6 ClinicalTrials.gov number, NCT02618577; ISRCTN number, ISRCTN17309850.).

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.

[Mentorship in electrophysiology : What does it take? What's the advantage?] / Mentorship in der Rhythmologie : Was braucht es? Was bringt es?

Mentoring has long been a fundamental part of medical education. In this article, the term mentoring is defined and the requirements, advantages, and methods of structuring are discussed. Further, the use of mentoring in the context of education in electrophysiology will be highlighted. In this setting, requirements on the personal level of mentors and mentees as well as on the institutional level are outlined, and different phases and types of mentoring are discussed.

EASY-WPW: a novel ECG-algorithm for easy and reliable localization of manifest accessory pathways in children and adults.

AIMS: Accessory pathway (AP) ablation is a standard procedure for the treatment of Wolff-Parkinson-White syndrome (WPW). Twelve-lead electrocardiogram (ECG)-based delta wave analysis is essential for predicting ablation sites. Previous algorithms have shown to be complex, time-consuming, and unprecise. We aimed to retrospectively develop and prospectively validate a new, simple ECG-based algorithm considering the patients' heart axis allowing for exact localization of APs in patients undergoing ablation for WPW. METHODS AND RESULTS: Our multicentre study included 211 patients undergoing ablation of a single manifest AP due to WPW between 2013 and 2021. The algorithm was developed retrospectively and validated prospectively by comparing its efficacy to two established ones (Pambrun and Arruda). All patients (32 ± 19 years old, 47% female) underwent successful pathway ablation. Prediction of AP-localization was correct in 197 patients (93%) (sensitivity 92%, specificity 99%, PPV 96%, and NPV 99%). Our algorithm was particularly useful in correctly localizing antero-septal/-lateral (sensitivity and specificity 100%) and posteroseptal (sensitivity 98%, specificity 92%) AP in proximity to the tricuspid valve. The accuracy of EASY-WPW was superior compared to the Pambrun (93% vs. 84%, P = 0.003*) and the Arruda algorithm (94% vs. 75%, P < 0.001*). A subgroup analysis of children (n = 58, 12 ± 4 years old, 55% female) revealed superiority to the Arruda algorithm (P < 0.001*). The reproducibility of our algorithm was excellent (Ï°>0.8; P < 0.001*). CONCLUSION: The novel EASY-WPW algorithm provides reliable and accurate pre-interventional ablation site determination in WPW patients. Only two steps are necessary to locate left-sided AP, and three steps to determine right-sided AP.

Ablation of typical atrial flutter as therapeutic component in carcinoid heart disease: a case report.

BACKGROUND: Carcinoid heart disease is the cardiac manifestation of carcinoid syndrome. There is limited research on rhythm management in patients with carcinoid heart disease. The association of typical atrial flutter and carcinoid heart disease in particular is poorly described. CASE PRESENTATION: Here we present a case of a 77-year-old German woman with carcinoid heart disease and recurrent typical atrial flutter complicating the postoperative course after tricuspid valve replacement and its successful long-term rhythm control by ablation therapy. CONCLUSION: There is limited evidence on rhythm management in patients with the rare diagnosis of carcinoid heart disease. Typical atrial flutter repeatedly complicated the postoperative course of our patient with carcinoid heart disease and could finally be treated curatively by ablation. Radiofrequency ablation should be considered as a valuable therapeutic component in the challenging therapy of this disease.

Ablation Therapy as Management of Typical Atrial Flutter in the Early Period After Cardiac Surgery.

INTRODUCTION: Available data on management of atrial flutter in the early postoperative setting after cardiac surgery are scarce. We aimed to investigate the safety and efficacy (profile) of flutter ablation in the early postoperative phase (30 days after cardiac surgery) in a cohort of 47 consecutive patients. METHODS: Between 2007 and 2016, 47 patients who underwent ablation for postoperative typical atrial flutter were retrospectively identified and analyzed. Follow-up data were acquired from patients' records in case of rehospitalization and via follow-up calls. RESULTS: The median age of patients was 69 years, 89% male and with a median LV-EF of 55%. CAD was present in 80.8% of patients. The predominant conduction of atrial flutter was 2:1 (76.6%); 85.1% of patients had either undergone CABG, SAVR, or a combination of these two. Acute procedural success could be achieved in 100% of patients with one vascular pseudoaneurysm that was managed conservatively. No other complications occurred. After a median follow-up of 5.7 years, follow-up information regarding heart rhythm was available in 87.2% of patients. One patient (2.1%) had undergone repeat ablation for typical flutter. Two patients (4.2%) had developed atrial fibrillation, while 87.2% of patients were in sinus rhythm. CONCLUSIONS: In this small cohort, early postoperative ablation of typical flutter was associated with a favorable short- and long-term safety and efficacy profile and can be considered part of heart rhythm management options in this setting.

Typical atrial flutter but not fibrillation predicts coronary artery disease in formerly healthy patients.

AIMS: Long-term mortality after ablation of typical atrial flutter has been found to be increased two-fold in comparison to atrial fibrillation ablations through a period of 5 years with unclear mechanism. METHODS AND RESULTS: We analysed 189 consecutive patients who underwent ablation for typical atrial flutter (AFL), in which the incidence of AF was the first manifestation of cardiac disease. According to the clinical standards of our centre, the routine recommendation was to evaluate for coronary artery disease (CAD) by invasive angiogram or computed tomography scan. We compared the AFL patients to 141 patients with paroxysmal atrial fibrillation (AFIB) without known structural heart disease who underwent ablation in the same period and who had routine coronary angiograms performed. Out of 189 patients who presented with AFL, coronary status was available in 152 patients (80.4%). Both groups were balanced for mean age (64.9 years in AFL vs. 63.2 years in AFIB; P = 0.15), body mass index (BMI; 28.8 vs. 28.5 kg/m2; P = 0.15), CHA2DS2-VASc-Score (2.20 vs. 2.04; P = 0.35), smoking status (22.2% smokers vs. 28.4%; P = 0.23), and renal function (GFR >60 mL/min in 96.7% of all patients vs. 95.7%; P = 0.76). There were significantly lower values for left ventricular ejection fraction (52.5% vs. 59.7%; P < 0.001), female sex (17.0% vs. 47.5%; P < 0.001), hyperlipidaemia (37.9% vs. 58.9%; P < 0.001), and family history of cardiovascular disease (CVD) (15.0 vs. 31.9%; P = 0.001) in the AFL vs. AFIB cohorts. Coronary artery disease with stenoses >50% was found in 26.3% of all patients with available coronary status in AFL and in 7.0% in AFIB (P < 0.001). Coronary artery disease with stenoses >75% in 16.4% in AFL whereas only in 1.4% in AFIB (P < 0.001). Multivessel disease was detected in 10.5% in AFL and 0.7% in AFIB (P < 0.001). After correction for age, left ventricular ejection fraction, BMI, CHA2DS2-VASc-Score and its individual components, smoking status, hyperlipidaemia, and family history of CVD, there was a more than five-fold increase in the likelihood of CAD with stenosis >50% in AFL as compared to AFIB [odds ratio (OR 5.26)]. A multivariate analysis was performed in the AFL group. Patients with clinically relevant stenoses (>75%) were older (70.6 years vs. 63.8 years; P = 0.001), had a higher number of risk factors (3.08 vs. 2.24; P ≤ 0.0016) and a higher CHA2DS2-VASc-Score (3.20 vs. 2.00; P < 0.0001). With logistic regression, significant CAD could be predicted by higher values for CHA2DS2-VASc-Score with an exponential rise to a pretest-probability of 42.1% at a value of 4 points. CONCLUSION: These data suggest that typical atrial flutter constitutes a manifestation of previously asymptomatic CAD. Due to the inclusion criteria, CAD has to be considered silent and chronic in most of the patients. Therefore, the presence of typical atrial flutter in formerly healthy patients should raise suspicion of otherwise silent CAD and initiate further investigations and risk stratification with particular emphasis on the individual CHA2DS2-VASc-Scores.

Cardiac Mapping Systems: Rhythmia, Topera, EnSite Precision, and CARTO.

Novel cardiac mapping systems allow a safe and highly accurate 3-D reconstruction of cardiac structures as well as fast and accurate visualization of cardiac arrhythmias. In addition, they are increasingly reducing the need for fluoroscopy in these procedures. The current state of the art, as well as the presentation of possible uses of individual systems and their limitations, is presented in this article. Cardiac mapping systems can significantly contribute to an optimal therapeutic decision making in invasive electrophysiology. This article introduces new developments of Rhythmia, Topera, EnSite Precision, and CARTO systems and provides a look ahead to the future.

3D Mapping for PVI- Geometry, Image Integration and Incorporation of Contact Force Into Work Flow.

Catheter ablation of atrial fibrillation has evolved enormously thanks to rapid improvement of modern mapping technologies, progress in catheter development and current possibilities for reduction of radiation exposure. Pulmonary vein isolation is thereby the cornerstone in this interventional treatment. Increased precision of catheter localization by modern three-dimensional mapping systems, faster and better processing of local electrograms and their immediate color-based visualization make it possible to treat even challenging arrhythmias very effectively. The commonly used three-dimensional mapping systems CARTO 3 (Biosense Webster, Irvine, Ca.) and Ensite Precision (St. Jude Medical, St. Paul, Min) differ in construction and principles of the underlying mapping technology. In this review article, we aim to emphasize the most important aspects of possibilities that make both systems so valuable for interventional treatment of atrial fibrillation. We present a modern workflow, that unites three-dimensional LA mapping with collecting relevant local information, image integration for refining the map and beneficial use of contact force based ablation approach.

Dual Antithrombotic Therapy with Clopidogrel and Novel Oral Anticoagulants in Patients with Atrial Fibrillation Undergoing Percutaneous Coronary Intervention: A Real-world Study.

INTRODUCTION: For patients with atrial fibrillation (AF) undergoing percutaneous coronary intervention (PCI), proper antithrombotic therapy is equivocal. Current guidelines recommend triple therapy, which carries a high risk of bleeding. Recent large trials suggest that dual therapy (DT) with novel oral anticoagulant (NOAC) plus P2Y12 inhibitor can be an appropriate alternative, but real-world data for this alternative are scarce and the optimal duration of DT has not yet been established. METHODS: This analysis was performed in a single-center prospective cohort. We investigated 216 PCI patients with indication for anticoagulation due to AF. After PCI patients received DT with reduced doses NOAC plus P2Y12 inhibitor for 6 months, which was followed by standard dose NOAC monotherapy. Efficacy endpoints were defined as cardiac death, myocardial infarction (MI), stent thrombosis (ST), and stroke. Safety endpoints were bleeding events as defined by Bleeding Academic Consortium (BARC). RESULTS: Baseline characteristics of our study population were described by a CHA2DS2-VASc score of greater than 4 and a HAS-BLED score of greater than 3. After a mean follow-up of 18.7 months, efficacy events occurred in 12 patients (5.6%). We observed three (1.4%) cardiac deaths, two (0.9%) MIs, six (2.8%) strokes, and one (0.5%) definite ST. After switching from DT to NOAC monotherapy after 6.3 ± 1.7 months, there was no rebound of ischemic events. Bleeding events occurred in 34 patients (15.7%) mainly under DT, while bleeding was less during NOAC monotherapy. CONCLUSIONS: In this long-term study of high-risk and real-world AF-patients with PCI, DT with NOAC and P2Y12 inhibitor (6 months) followed by NOAC monotherapy was safe and effective.