Impact of atrial fibrillation on 1-year outcome in patients with implantable cardioverter defibrillator or cardiac resynchronization therapy with defibrillator: results from the German DEVICE Registry.

Background: Atrial fibrillation (AF) is a cardiac arrhythmia frequently documented in patients requiring implantable cardioverter defibrillators (ICDs) and/or cardiac resynchronization therapy with defibrillator (CRT-D). Patients with diagnosed AF at the point of ICD or CRT-D implantation may have an impaired follow-up outcome. Methods: The German DEVICE I-II registry is a nationwide prospective multicentre database of patients implanted with ICD and CRT-D with clinical follow-up data. We analysed a 1-year follow up of implanted patients with AF and with sinus rhythm (SR). Results: A total of 4,929 ICD/CRT patients are included in the present analysis: 946 (19.2%) were in AF and 3,983 (80.8%) were SR at time of device implantation. AF patients had a significantly more comorbid profile including older age {72 [interquartile range (IQR), 66-77] vs. 66 (IQR, 56-73) years; P<0.001}, and higher rate of patients with left ventricular ejection fraction <30% (68.2% vs. 61.0%; P<0.001), peripheral artery disease (4.5% vs. 2.7%; P=0.002), diabetes (33.6% vs. 25.5%; P<0.001), hypertension (58.4% vs. 51.1%; P<0.001) and renal failure (22.6% vs. 15.3%; P<0.001). The intra-hospital complication rate was 4.3% in the AF and 3.6% in the SR group (P=0.38). In 1-year follow-up AF patients experienced a significantly higher rate of defibrillator shocks (25% vs. 15.3%; P<0.001). One-year estimated mortality was 10.8% in the AF and 5.9% in the SR group (P<0.001), while estimated 1-year major adverse cardiac and cerebrovascular events (MACCE) rate was 11.2% vs. 7.0% (P<0.001). The effects of AF on electrical shocks and mortality persisted after adjusting for age, sex, advanced New York Heart Association (NYHA) class, severely impaired left ventricular ejection fraction (LVEF), coronary artery disease (CAD), chronic obstructive pulmonary disease (COPD), diabetes mellitus (DM), chronic renal failure (CRF), QRS duration, and type of indication for electronic device implantation. Conclusions: Our clinical data on an extended cohort of contemporary patients confirm the significant impact of AF, and its associated comorbidities, upon mortality and major adverse events after implantation of ICD/CRT.

Accuracy and comprehensibility of chat-based artificial intelligence for patient information on atrial fibrillation and cardiac implantable electronic devices.

AIMS: Natural language processing chatbots (NLPC) can be used to gather information for medical content. However, these tools contain a potential risk of misinformation. This study aims to evaluate different aspects of responses given by different NLPCs on questions about atrial fibrillation (AF) and clinical implantable electronic devices (CIED). METHODS AND RESULTS: Questions were entered into three different NLPC interfaces. Responses were evaluated with regard to appropriateness, comprehensibility, appearance of confabulation, absence of relevant content, and recommendations given for clinically relevant decisions. Moreover, readability was assessed by calculating word count and Flesch Reading Ease score. 52, 60, and 84% of responses on AF and 16, 72, and 88% on CIEDs were evaluated to be appropriate for all responses given by Google Bard, (GB) Bing Chat (BC) and ChatGPT Plus (CGP), respectively. Assessment of comprehensibility showed that 96, 88, and 92% of responses on AF and 92 and 88%, and 100% on CIEDs were comprehensible for all responses created by GB, BC, and CGP, respectively. Readability varied between different NLPCs. Relevant aspects were missing in 52% (GB), 60% (BC), and 24% (CGP) for AF, and in 92% (GB), 88% (BC), and 52% (CGP) for CIEDs. CONCLUSION: Responses generated by an NLPC are mostly easy to understand with varying readability between the different NLPCs. The appropriateness of responses is limited and varies between different NLPCs. Important aspects are often missed to be mentioned. Thus, chatbots should be used with caution to gather medical information about cardiac arrhythmias and devices.

Safety, usability, and performance of a wireless left atrial pressure monitoring system in patients with heart failure: the VECTOR-HF trial.

AIMS: In heart failure (HF), implantable haemodynamic monitoring devices have been shown to optimize therapy, anticipating clinical decompensation and preventing hospitalization. Direct left-sided haemodynamic sensors offer theoretical benefits beyond pulmonary artery pressure monitoring systems. We evaluated the safety, usability, and performance of a novel left atrial pressure (LAP) monitoring system in HF patients. METHODS AND RESULTS: The VECTOR-HF study (NCT03775161) was a first-in-human, prospective, multicentre, single-arm, clinical trial enrolling 30 patients with HF. The device consisted of an interatrial positioned leadless sensor, able to transmit LAP data wirelessly. After 3 months, a right heart catheterization was performed to correlate mean pulmonary capillary wedge pressure (PCWP) with simultaneous mean LAP obtained from the device. Remote LAP measurements were then used to guide patient management. The miniaturized device was successfully implanted in all 30 patients, without acute major adverse cardiac and neurological events (MACNE). At 3 months, freedom from short-term MACNE was 97%. Agreement between sensor-calculated LAP and PCWP was consistent, with a mean difference of -0.22 ± 4.92 mmHg, the correlation coefficient and the Lin's concordance correlation coefficient values were equal to 0.79 (p < 0.0001) and 0.776 (95% confidence interval 0.582-0.886), respectively. Preliminary experience with V-LAP-based HF management was associated with significant improvements in New York Heart Association (NYHA) functional class (32% of patients reached NYHA class II at 6 months, p < 0.005; 60% of patients at 12 months, p < 0.005) and 6-min walk test distance (from 244.59 ± 119.59 m at baseline to 311.78 ± 129.88 m after 6 months, p < 0.05, and 343.95 ± 146.15 m after 12 months, p < 0.05). CONCLUSION: The V-LAP™ monitoring system proved to be generally safe and provided a good correlation with invasive PCWP. Initial evidence also suggests possible improvement in HF clinical symptoms.

The V-LAP System for Remote Left Atrial Pressure Monitoring of Patients With Heart Failure: Remote Left Atrial Pressure Monitoring.

OBJECTIVE: Patients with heart failure (HF) are at an increased risk of hospital admissions. The aim of this report is to describe the feasibility, safety and accuracy of a novel wireless left atrial pressure (LAP) monitoring system in patients with HF. METHODS: The V-LAP Left Atrium Monitoring systEm for Patients With Chronic sysTOlic & Diastolic Congestive heart Failure (VECTOR-HF) study is a prospective, multicenter, single-arm, open-label, first-in human clinical trial to assess the safety, performance and usability of the V-LAP system (Vectorious Medical Technologies) in patients with New York Heart Association class III HF. The device was implanted in the interatrial septum via a percutaneous, trans-septal approach guided by fluoroscopy and echocardiography. Primary endpoints included the successful deployment of the implant, the ability to perform initial pressure measurements and safety outcomes. RESULTS: To date, 24 patients have received implants of the LAP-monitoring device. No device-related complications have occurred. LAP was reported accurately, agreeing well with wedge pressure at 3 months (Lin concordance correlation coefficient = 0.850). After 6 months, New York Heart Association class improved in 40% of the patients (95% CI = 16.4%-63.5%), while the 6-minute walk test distance had not changed significantly (313.9 ± 144.9 vs 232.5 ± 129.9 meters; P = 0.076). CONCLUSION: The V-LAP left atrium monitoring system appears to be safe and accurate.

Complications and mortality after catheter ablation of ventricular arrhythmias: risk in VT ablation (RIVA) score.

AIMS: Catheter ablation of ventricular arrhythmias (VA) has proven to be an effective therapeutic option for secondary arrhythmia prophylaxis. We sought to assess the procedural efficacy, safety and in-hospital mortality of a large patient cohort with and without structural heart disease undergoing VA ablation. METHODS: A total of 1417 patients (804 patients with structural heart disease) undergoing 1792 endo- and epicardial procedures were analyzed. Multivariable risk factor analysis for occurrence of major complications and intrahospital mortality was obtained and a score to allow preprocedural risk assessment for patients undergoing VA ablation procedures was established. RESULTS: Major complication occurred in 4.4% of all procedures and significantly more often in patients with structural heart disease than in structurally normal hearts (6.0 vs. 1.8%). The frequency of these periprocedural complications was significantly different between procedures with sole right ventricular and a combination of RV and LV access (0.5 vs. 3.1%). The most common complication was cardiac tamponade in 46 cases (3.0%). Intrahospital death was observed in 32 patients (1.8%). Logistic regression model revealed presence of ischemic heart disease, epicardial ablation, presence of oral anticoagulation or dual antiplatelet therapy as independent risk factors for the occurrence of complications or intrahospital death, while a history of previous heart surgery was an independent predictor with a decreased risk. Based on this analysis a risk score incorporating 5 standard variables was established to predict the occurrence of complications and intrahospital mortality. CONCLUSIONS: Safety of VA catheter ablation mainly relies on patient baseline characteristics and the type of access into the ventricles or epicardial space.

[Atrial fibrillation and the limits of oral anticoagulation: for whom are left atrial appendage occluders suitable?] / Vorhofflimmern und Grenzen der oralen Antikoagulation ­ für wen eignen sich Vorhofohrokkluder?

BACKGROUND: Patients with atrial fibrillation are at a significantly increased risk of thromboembolic events, especially ischemic strokes. Oral anticoagulation reduces this risk, but cannot be used in some patients for various reasons and is associated with a relevantly increased risk of bleeding. As an alternative for prophylaxis of thromboembolic events in patients with atrial fibrillation, there are different options of left atrial appendage closure. AIM: This article explains the possibilities of interventional atrial occlusion as well as the suitable patient clientele using an overview of the currently available systems for atrial occlusion, a guideline for patient selection and a summary of the current scientific data. CONCLUSION AND AVAILABLE SCIENTIFIC DATA: In carefully selected patients suffering from atrial fibrillation with relative or absolute contraindications for oral anticoagulation, interventional closure of the atrial appendage is a safe alternative for prophylaxis against thromboembolic events. The currently available scientific evidence from randomized controlled trials is sparse. Nevertheless, extensive amounts of registry study data suggest a benefit, while the results of several large randomized controlled trials are expected in the coming years.

Implantation of an Innovative Intracardiac Microcomputer System for Web-Based Real-Time Monitoring of Heart Failure: Usability and Patients' Attitudes.

BACKGROUND: Heart failure (HF) management guided by the measurement of intracardiac and pulmonary pressure values obtained through innovative permanent intracardiac microsensors has been recently proposed as a valid strategy to individualize treatment and anticipate hemodynamic destabilization. These sensors have potential to reduce patient hospitalization rates and optimize quality of life. OBJECTIVE: The aim of this study was to evaluate the usability and patients' attitudes toward a new permanent intracardiac device implanted to remotely monitor left intra-atrial pressures (V-LAP, Vectorious Medical Technologies, Tel Aviv, Israel) in patients with chronic HF. METHODS: The V-LAP system is a miniaturized sensor implanted percutaneously across the interatrial septum. The system communicates wirelessly with a "companion device" (a wearable belt) that is placed on the patient's chest at the time of acquisition/transmission of left heart pressure measurements. At first follow-up after implantation, the patients and health care providers were asked to fill out a questionnaire on the usability of the system, ease in performing the various required tasks (data acquisition and transmission), and overall satisfaction. Replies to the questions were mainly given using a 5-point Likert scale (1: very poor, 2: poor, 3: average, 4: good, 5: excellent). Further patient follow-ups were performed at 3, 6, and 12 months. RESULTS: Use and acceptance of the first 14 patients receiving the V-LAP technology worldwide and related health care providers have been analyzed to date. No periprocedural morbidity/mortality was observed. Before discharge, a tailored educational session was performed after device implantation with the patients and their health care providers. At the first follow-up, the mean score for overall comfort in technology use was 3.7 (SD 1.2) with 93% (13/14) of patients succeeding in applying and operating the system independently. For health care providers, the mean score for overall ease and comfort in use of the technology was 4.2 (SD 0.8). No significant differences were found between the patients' and health care providers' replies to the questionnaires. There was a general trend for higher scores in patients' usability reports at later follow-ups, in which the score related to overall comfort with using the technology increased from 3.0 (SD 1.4) to 4.0 (SD 0.7) (P=.40) and comfort with wearing and adjusting the measuring thoracic belt increased from 2.8 (SD 1.0) to 4.2 (SD 0.4) (P=.02). CONCLUSIONS: Despite the gravity of their HF pathology and the complexity of their comorbid profile, patients are comfortable in using the V-LAP technology and, in the majority of cases, they can correctly and consistently acquire and transmit hemodynamic data. Although the overall patient/care provider satisfaction with the V-LAP system seems to be acceptable, improvements can be achieved after ameliorating the design of the measuring tools. TRIAL REGISTRATION: ClincalTrials.gov NCT03775161; https://clinicaltrials.gov/ct2/show/NCT03775161.

Treating Mitral Valve Prolapse in Barlow's Disease by Creation of a Medial MitraClip Bridge and a "New" Lateral Orifice: Rationale for MitraClip NTR Adoption.

Percutaneous mitral valve repair with MitraClip XTR (Abbott Vascular) has been proposed in patients with Barlow's disease, as the extended length of the MitraClip XTR may facilitate "grasping" and limit the number of clips. However, the design of the MitraClip XTR includes arms that 3 mm longer than the NTR device as well as 2 additional frictional elements, and requires a patient selection based mainly on mitral valve tissue quality. We summarize our rationale for using the shorter and smaller MitraClip NTR in patients with Barlow's disease.

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.

Outcome of cardiac tamponades in interventional electrophysiology.

AIMS: The aim of this study was to analyse tamponades following electrophysiological procedures regarding frequency and mortality in a high-volume centre and to identify independent predictors for severe tamponades. METHODS AND RESULTS: We performed a retrospective study on 34 982 consecutive patients undergoing diagnostic electrophysiological studies or catheter ablation of cardiac arrhythmias. The combined endpoint was defined as severe tamponade. Criteria for severe tamponade included surgical repair, repeat pericardiocentesis, cardiopulmonary resuscitation, intrahospital death or death during follow-up, and thrombo-embolic events or complications due to therapeutic management. Multivariate analysis was performed to identify independent predictors for severe tamponade. A total of 226 tamponades were identified. Overall frequency of tamponades was 0.6%. Procedures requiring epicardial approach had the highest rate of tamponades (9.4%). Twenty-nine patients with tamponade underwent surgery (12.8% of all tamponades and 21.4% of tamponades during epicardial procedures). Overall tamponade-related mortality was 0.03% (9 deaths). Fifty-six patients (24.8%) experienced severe tamponade. Independent risk factors for severe tamponades were endocardial ablation of ventricular tachycardia, epicardial approach, balloon device ablation, high aspiration volume during pericardiocentesis and structural heart disease. CONCLUSION: The frequency of tamponades is strongly dependent on the type of procedure performed. Overall tamponade-related mortality was low but significantly higher in patients undergoing epicardial procedures. Surgical backup should be considered for patients undergoing complex ventricular tachycardia ablation and left atrial ablation procedures.

Percutaneous left atrial appendage closure for cerebrovascular accident prevention: rationale, indications, technical aspects, clinical results and future perspective.

Atrial fibrillation (AF) is the most common sustained cardiac arrhythmia. The most feared complication of AF is thromboembolism. Oral anticoagulation (OAC) is the standard treatment to reduce thromboembolism occurrence in patients with AF. The rate of relevant bleeding, medical interactions and incompliance under OAC remains consistent. In this context, patients with AF at high risk for thromboembolism and with a contraindication to OAC may be considered as candidates for percutaneous left atrial appendage closure. In this review, we discuss the rationale, indications, technical aspects and clinical results of left atrial appendage closure by means of the WATCHMAN® (Boston Scientific, MA, USA) device.

Intra-cardiac microcomputer allows for innovative telemedicine in chronic heart failure during coronavirus disease-2019 pandemic: a case report.

BACKGROUND: Heart failure patient management guided by invasive intra-cardiac and pulmonary pressure measurements through permanent intra-cardiac micro-sensors has recently been published as a strategy to individualize the therapy of patients with chronic heart failure to reduce re-hospitalization and optimize quality of life. Furthermore, the use of telemedicine could have an important impact on infective disease spread during the current coronavirus disease-2019 pandemic. CASE SUMMARY: Emergent hospitalization of a patient with acute on chronic heart failure, who is currently in self-isolation as a result of his comorbid profile that exposes him to high risk for severe course and mortality in case of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection was prevented using a last generation telemedicine tool. DISCUSSION: Further implementation of invasive telemedicine could prevent hospitalization for acute decompensated heart failure and consecutive exposure to a potential hospital infection with SARS-CoV-2 in high-risk patients.

Routine Transesophageal Echocardiography in Atrial Fibrillation Before Electrical Cardioversion to Detect Left Atrial Thrombosis and Echocontrast.

BACKGROUND: Transesophageal echocardiography (TEE) before electrical cardioversion (ECV) in atrial fibrillation (AF) is not routinely performed in anticoagulated patients. METHODS: Starting from TEE findings of anticoagulated and non-anticoagulated patients referred for ECV, we investigated the rate of spontaneous echo-contrast (SEC) and left atrial thrombus (LAT) and identified their independent predictors. RESULTS: A total of 403 patients were included: 262 (65%) had no anticoagulation, 47 (11.7%) were onnovel oral anticoagulant (rivaroxaban), 74 (18.4%) on warfarin INR>2, and 20 (5.0%) on warfarin INR<2.In 41 (10.1%) there was LAT and in 154 (38.2%) SEC. Patients with LAT had a significantly lower left ventricular ejection fraction (LVEF%) (p=0.001). Patients with SEC were significantly older (p=0.04), had lower LVEF% (p<0.0001),higher CHADSVASC score (p<0.0001), and higher rate of coronary artery disease (CAD) (p=0.03). In 56.8% of warfarin patients (INR>2) there was SEC (p=0.002). At multivariate analysis therapeutic anticoagulation with warfarin (p=0.003; OR:2.2; CI: 1.3-3.7),CHADSVASC score (p<0.0001; OR=1.2; CI: 1.1-1.4), and LVEF% (p<0.0001; OR:0.95; CI: 0.93-0.97; inverse relationship) were SEC predictors. A 3.5 CHADSVASC score cut-off was predictor of SEC (AUC: 0.7; p<0.0001). LVEF% was the only predictor of LAT (p=0.02; OR=0.96; CI: 0.93-0.99; inverse relationship). CONCLUSIONS: Echocardiography before ECV identifies clear LAT/SEC in more than a third of AF patients, independently by their anticoagulation regimen. LAT/SEC rates increasewith decrement of LVEF%. Increment of CHADSVASC score increases SEC risk. In anticoagulated patients SEC rate remains higher than expected. Therapeutic anticoagulation with Warfarin appears positively and independently correlated to SEC occurrence.

Management of arrhythmia recurrence in patients with pulmonary vein stenosis following atrial fibrillation ablation.

AIMS: Arrhythmia recurrence is a common clinical problem in patients with pulmonary vein stenosis (PVS) following catheter ablation of atrial fibrillation. The study sought to analyse the management of arrhythmia recurrence in patients with PVS. METHODS AND RESULTS: Retrospective analysis was performed on 29 patients with high-degree PVS. Follow-up contained clinical visits, Holter-electrocardiogram recordings and invasive pulmonary vein (PV) angiography and electrophysiological studies. Arrhythmia recurrence was observed in 18 patients (62%) after PVS formation. Fifteen of 18 patients (83.3%) with and 1 of 11 patients (9.1%) without arrhythmia recurrence had electrical PV reconnection (P = 0.0003). In 14 of 16 patients repeat pulmonary vein isolation (PVI) was conducted (radiofrequency ablation in 12 and cryoballoon ablation in 2 cases). Repeat PVI was successful in all PVs in nine patients and incomplete in five patients (failed attempt in two patients with stent implantation, no attempt in three patients with stenotic PVs). Freedom from arrhythmia recurrence was estimated at 56.3% [95% confidence interval (CI) 36.4-72.0%] after 24 months. At the end of the follow-up, complete PVI was documented in 19 of 23 patients (82.6%) with stable sinus rhythm and in 2 of 6 patients with arrhythmia recurrence (33.3%) (P = 0.0335). The Kaplan-Meier estimate of recurrence-free survival of restenosis after interventional PVS treatment was similar in patients without and with repeat ablation [75.6% (95% CI 57.0-94.3%) and 67.0% (95% CI 43.2-90.7%) after 500 days, P = 0.77]. CONCLUSIONS: Pulmonary vein reconnection is the major driver of arrhythmia recurrence in PVS patients. Repeat PVI is feasible and does not lead to progression of PVS or restenosis if the procedure is carefully performed.