Anticoagulation for post-operative atrial fibrillation after isolated coronary artery bypass grafting: a meta-analysis.

BACKGROUND AND AIMS: This study aimed to evaluate clinical outcomes in patients developing post-operative atrial fibrillation (POAF) after coronary artery bypass grafting (CABG) and characterize variations in oral anticoagulation (OAC) use, benefits, and complications. METHODS: A systematic search identified studies on new-onset POAF after CABG and OAC initiation. Outcomes included risks of thromboembolic events, bleeding, and mortality. Furthermore, a meta-analysis was conducted on these outcomes, stratified by the use or non-use of OAC. RESULTS: The identified studies were all non-randomized. Among 1 698 307 CABG patients, POAF incidence ranged from 7.9% to 37.6%. Of all POAF patients, 15.5% received OAC. Within 30 days, thromboembolic events occurred at rates of 1.0% (POAF: 0.3%; non-POAF: 0.8%) with 2.0% mortality (POAF: 1.0%; non-POAF: 0.5%). Bleeding rates were 1.1% for POAF patients and 2.7% for non-POAF patients. Over a median of 4.6 years, POAF patients had 1.73 thromboembolic events, 3.39 mortality, and 2.00 bleeding events per 100 person-years; non-POAF patients had 1.14, 2.19, and 1.60, respectively. No significant differences in thromboembolic risks [effect size -0.11 (-0.36 to 0.13)] and mortality [effect size -0.07 (-0.21 to 0.07)] were observed between OAC users and non-users. However, OAC use was associated with higher bleeding risk [effect size 0.32 (0.06-0.58)]. CONCLUSIONS: In multiple timeframes following CABG, the incidence of complications in patients who develop POAF is low. The use of OAC in patients with POAF after CABG is associated with increased bleeding risk.

Body mass index and pulmonary vein isolation: real-world data on outcomes and quality of life.

AIMS: Increasing numbers of overweight and obese patients undergo pulmonary vein isolation (PVI), despite the association between higher body mass index (BMI) and adverse PVI outcomes. Evidence on complications and quality of life in different bodyweight groups is limited. This study aims to clarify the impact of BMI on repeat ablations, periprocedural complications, and changes in quality of life. METHODS AND RESULTS: This multi-centre study analysed prospectively collected data from 15 ablation centres, covering all first-time PVI patients in the Netherlands from 2015 to 2021. Patients were categorized by BMI: normal weight (18.5-24.9 kg/m2), overweight (25-29.9 kg/m2), and obesity (≥30 kg/m2). Quality of life was assessed using the Atrial Fibrillation Effect on QualiTy-of-life questionnaire at baseline and 1-year post-PVI. Among 20 725 patients, 30% were of normal weight, 47% overweight, and 23% obese. Within the first year after PVI, obese patients had a higher incidence of repeat ablations than normal-weighing and overweight patients (17.8 vs. 15.6 and 16.1%, P < 0.05). Obesity was independently associated with repeat ablations (odds ratio 1.15; 95% confidence interval 1.01-1.31, P = 0.03). This association remained apparent after 3 years. Complication rates were 3.8% in normal weight, 3.0% in overweight, and 4.6% in obese, with weight class not being an independent predictor. Quality of life improved in all weight groups post-PVI but remained lowest in obese patients. CONCLUSION: Obesity is independently associated with a higher rate of repeat ablations. Pulmonary vein isolation is equally safe in all weight classes. Despite lower quality of life among obese individuals, substantial improvements occur for all weight groups after PVI.

Re-ordered fuzzy conformance checking for uncertain clinical records.

Modern hospitals implement clinical pathways to standardize patients' treatments. Conformance checking techniques provide an automated tool to assess whether the actual executions of clinical processes comply with the corresponding clinical pathways. However, clinical processes are typically characterized by a high degree of uncertainty, both in their execution and recording. This paper focuses on uncertainty related to logging clinical processes. The logging of the activities executed during a clinical process in the hospital information system is often performed manually by the involved actors (e.g., the nurses). However, such logging can occur at a different time than the actual execution time, which hampers the reliability of the diagnostics provided by conformance checking techniques. To address this issue, we propose a novel conformance checking algorithm that leverages principles of fuzzy set theory to incorporate experts' knowledge when generating conformance diagnostics. We exploit this knowledge to define a fuzzy tolerance in a time window, which is then used to assess the magnitude of timestamp violations of the recorded activities when evaluating the overall process execution compliance. Experiments conducted on a real-life case study in a Dutch hospital show that the proposed method obtains more accurate diagnostics than the state-of-the-art approaches. We also consider how our diagnostics can be used to stimulate discussion with domain experts on possible strategies to mitigate logging uncertainty in the clinical practice.

Pulsed field versus cryoballoon ablation for atrial fibrillation: a real-world observational study on procedural outcomes and efficacy.

INTRODUCTION: Atrial fibrillation often necessitates catheter ablation when antiarrhythmic drug therapy fails. Single-shot technologies using thermal energy, such as cryoballoon ablation, are commonly used, but pulsed field ablation (PFA), an innovative non-thermal ablation technique, is a potential alternative. This retrospective observational study aimed to compare the safety and efficacy of cryoballoon ablation and PFA in patients undergoing their first pulmonary vein isolation (PVI) procedure for atrial fibrillation treatment. METHODS: We utilised real-world data from patients who underwent PVI using cryoballoon ablation or PFA. The primary outcome encompassed procedural complications, including phrenic nerve palsy, cardiac tamponade, thromboembolic complications, bleeding complications and mortality. Secondary outcomes were procedural characteristics including procedure duration, length of hospital admission, and re-do ablation rates within 6 months. RESULTS: A total of 1714 procedures were analysed: 1241 in the cryoballoon group and 473 in the PFA group. Gender distribution (p = 0.03) and estimated glomerular filtration rate (p = 0.01) differed significantly. With regard to the primary outcome, the cryoballoon group demonstrated a higher incidence of phrenic nerve palsy compared with the PFA group (15 vs 0; p = 0.02). The procedure duration was shorter in the PFA group, even after adjusting for baseline characteristics (95.0 vs 74.0 min; p < 0.001). After adjustment for baseline characteristics, admission duration differed between the groups as well (p = 0.04). CONCLUSION: The study results supported the safety and efficacy of PFA over cryoballoon ablation for PVI, highlighting advantages such as shorter procedure duration and absence of phrenic nerve palsy.

The prognostic value of quality of life in atrial fibrillation on patient value.

BACKGROUND: In this study, the prognostic value of AF-related quality of life (AFEQT) at baseline on Major Adverse Cardiovascular Events (MACE) and improvement of perceived symptoms (EHRA) was assessed. Furthermore, the relationship between QoL and AF-related hospitalizations was assessed. METHODS: A cohort of AF-patients diagnosed between November 2014 and October 2019 in four hospitals embedded within the Netherlands Heart Network were prospectively followed for 12 months. MACE was defined as stroke, myocardial infarction, heart failure and/or mortality. Subsequently, MACE, EHRA score improvement and AF-related hospitalizations between baseline and 12 months of follow-up were recorded. RESULTS: In total, 970 AF-patients were available for analysis. In analyses with patients with complete information on the confounder subset 36/687 (5.2%) AF-patients developed MACE, 190/432 (44.0%) improved in EHRA score and 189/510(37.1%) were hospitalized during 12 months of follow-up. Patients with a low AFEQT score at baseline more often developed MACE (OR(95%CI): 2.42(1.16-5.06)), more often improved in EHRA score (OR(95%CI): 4.55(2.45-8.44) and were more often hospitalized (OR(95%CI): 4.04(2.22-7.01)) during 12 months post diagnosis, compared to patients with a high AFEQT score at baseline. CONCLUSIONS: AF-patients with a lower quality of life at diagnosis more often develop MACE, more often improve on their symptoms and also were more often hospitalized, compared to AF-patients with a higher quality of life. This study highlights that the integration of patient-reported outcomes, such as quality of life, has the potential to be used as a prognostic indicator of the expected disease course for AF.

Early or Delayed Cardioversion in Recent-Onset Atrial Fibrillation.

BACKGROUND: Patients with recent-onset atrial fibrillation commonly undergo immediate restoration of sinus rhythm by pharmacologic or electrical cardioversion. However, whether immediate restoration of sinus rhythm is necessary is not known, since atrial fibrillation often terminates spontaneously. METHODS: In a multicenter, randomized, open-label, noninferiority trial, we randomly assigned patients with hemodynamically stable, recent-onset (<36 hours), symptomatic atrial fibrillation in the emergency department to be treated with a wait-and-see approach (delayed-cardioversion group) or early cardioversion. The wait-and-see approach involved initial treatment with rate-control medication only and delayed cardioversion if the atrial fibrillation did not resolve within 48 hours. The primary end point was the presence of sinus rhythm at 4 weeks. Noninferiority would be shown if the lower limit of the 95% confidence interval for the between-group difference in the primary end point in percentage points was more than -10. RESULTS: The presence of sinus rhythm at 4 weeks occurred in 193 of 212 patients (91%) in the delayed-cardioversion group and in 202 of 215 (94%) in the early-cardioversion group (between-group difference, -2.9 percentage points; 95% confidence interval [CI], -8.2 to 2.2; P = 0.005 for noninferiority). In the delayed-cardioversion group, conversion to sinus rhythm within 48 hours occurred spontaneously in 150 of 218 patients (69%) and after delayed cardioversion in 61 patients (28%). In the early-cardioversion group, conversion to sinus rhythm occurred spontaneously before the initiation of cardioversion in 36 of 219 patients (16%) and after cardioversion in 171 patients (78%). Among the patients who completed remote monitoring during 4 weeks of follow-up, a recurrence of atrial fibrillation occurred in 49 of 164 patients (30%) in the delayed-cardioversion group and in 50 of 171 (29%) in the early-cardioversion group. Within 4 weeks after randomization, cardiovascular complications occurred in 10 patients and 8 patients, respectively. CONCLUSIONS: In patients presenting to the emergency department with recent-onset, symptomatic atrial fibrillation, a wait-and-see approach was noninferior to early cardioversion in achieving a return to sinus rhythm at 4 weeks. (Funded by the Netherlands Organization for Health Research and Development and others; RACE 7 ACWAS ClinicalTrials.gov number, NCT02248753.).

Left atrial reservoir strain as a predictor of cardiac outcome in patients with heart failure: the HaFaC cohort study.

BACKGROUND: The left atrium (LA) is a key player in the pathophysiology of systolic and diastolic heart failure (HF). Speckle tracking derived LA reservoir strain (LASr) can be used as a prognostic surrogate for elevated left ventricular filling pressure similar to NT-proBNP. The aim of the study is to investigate the correlation between LASr and NT-proBNP and its prognostic value with regards to the composite endpoint of HF hospitalization and all-cause mortality within 1 year. METHODS: Outpatients, sent to the echocardiography core lab because of HF, were enrolled into this study. Patients underwent a transthoracic echocardiographic examination, commercially available software was used to measure LASr. Blood samples were collected directly after the echocardiographic examination to determine NT-proBNP. RESULTS: We included 174 HF patients, 43% with reduced, 36% with mildly reduced, and 21% with preserved ejection fraction. The study population showed a strong inverse correlation between LASr and log-transformed NT-proBNP (r = - 0.75, p < 0.01). Compared to NT-proBNP, LASr predicts the endpoint with a comparable specificity (83% vs. 84%), however with a lower sensitivity (70% vs. 61%). CONCLUSION: LASr is inversely correlated with NT-proBNP and a good echocardiographic predictor for the composite endpoint of hospitalization and all-cause mortality in patients with HF. TRIAL REGISTRATION: https://www.trialregister.nl/trial/7268.

Feasibility, safety and outcomes of upgrading to left bundle branch pacing in patients with right ventricular pacing induced cardiomyopathy.

BACKGROUND: Right ventricular pacing (RVP) induces abnormal electrical activation and asynchronous ventricular contraction and leads to pacing induced cardiomyopathy (PICM) in 10%-20% of patients. Cardiac resynchronization therapy (CRT) utilizing biventricular pacing (BVP) is the recommended treatment. Left bundle branch pacing (LBBP) is a novel physiological pacing technique which may serve as an alternative to CRT. This study assessed feasibility and outcomes of LBBP delivered CRT in patients with PICM. METHODS: Total 20 consecutive patients with PICM who received an upgrade of their pacemaker to LBBP were prospectively studied. Acute success rate, complications, functional and echocardiographic response, and hospitalization for heart failure within 6 months from implantation were evaluated. RESULTS: LBBP was successfully delivered in all patients. Median duration of RVP before upgrade to LBBP was 3.8 years and the RVP was 99%. LBBP resulted in significant QRS narrowing (from 193 ± 18 ms to 130 ± 17 ms [p < .001]), improvement in LVEF (from 32% ± 6 % to 47% ± 8% [p < .001]) and NYHA class (from 2.8 ± 0.4 to 1.4 ± 0.5 [p < .001]) at 6 months. No LBBP-related complications occurred. No patients were hospitalized for heart failure or died. CONCLUSION: LBBP is feasible and safe in delivering CRT in PICM. Preliminary analyses demonstrated significant electrical resynchronization and favorable improvement in LV function and NYHA functional class at short term follow-up. Data needs to be validated in large randomized controlled trials.

Effects of Video-Based Patient Education and Consultation on Unplanned Health Care Utilization and Early Recovery After Coronary Artery Bypass Surgery (IMPROV-ED): Randomized Controlled Trial.

BACKGROUND: Health care utilization after coronary artery bypass graft (CABG) surgery is high and is partly of an unplanned nature. eHealth applications have been proposed to reduce care consumption, which involve and assist patients in their recovery. In this way, health care expenses could be reduced and quality of care could be improved. OBJECTIVE: The aim of this study was to evaluate if an eHealth program can reduce unplanned health care utilization and improve mental and physical health in the first 6 weeks after CABG surgery. METHODS: A single-blind randomized controlled trial was performed, in which patients scheduled for nonacute CABG surgery were included from a single center in the Netherlands between February 2020 and October 2021. Participants in the intervention group had, alongside standard care, access to an eHealth program consisting of online education videos and video consultations developed in conjunction with the Dutch Heart Foundation. The control group received standard care. The primary outcome was the volume and costs of a composite of unplanned health care utilization, including emergency department visits, outpatient clinic visits, rehospitalization, patient-initiated telephone consultations, and visits to a general practitioner, measured using the Medical Technology Assessment Medical Consumption Questionnaire. Patient-reported anxiety and recovery were also assessed. Intention-to-treat and "users-only" analyses were used. RESULTS: During the study period, 280 patients were enrolled and randomly allocated at a 1:1 ratio to the intervention or control group. The intention-to-treat analysis consisted of 136 and 135 patients in the intervention and control group, respectively. At 6 weeks, the primary endpoint had occurred in 43 of 136 (31.6%) patients in the intervention group and in 61 of 135 (45.2%) patients in the control group (hazard ratio 0.56, 95% CI 0.34-0.92). Recovery was faster in the intervention group, whereas anxiety was similar between study groups. "Users-only" analysis yielded similar results. CONCLUSIONS: An eHealth strategy comprising educational videos and video consultations can reduce unplanned health care utilization and can aid in faster patient-reported recovery in patients following CABG surgery. TRIAL REGISTRATION: Netherlands Trial Registry NL8510; https://trialsearch.who.int/Trial2.aspx?TrialID=NL8510. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.1007/s12471-020-01508-9.

Initial rhythm control with cryoballoon ablation vs drug therapy: Impact on quality of life and symptoms.

BACKGROUND: Cryoballoon ablation (CBA) as a first-line rhythm control strategy is superior to antiarrhythmic drugs (AADs) for preventing atrial fibrillation (AF) recurrence; the impact of first-line CBA on quality of life (QoL) and symptoms has not been well characterized. METHODS: Patients aged 18 to 75 with symptomatic paroxysmal AF naïve to rhythm control therapy were randomized (1:1) to CBA (Arctic Front Advance, Medtronic) or AAD (Class I or III). Symptoms and QoL were assessed at baseline, 1, 3, 6, 9, and 12 months using the EHRA classification and Atrial Fibrillation Effect on QualiTy-of-Life (AFEQT) and SF-36v2 questionnaires. Symptomatic palpitations were evaluated via patient diary. RESULTS: Overall, 107 patients were randomized to CBA and 111 to AAD; crossovers occurred in 9%. Larger improvements in the AFEQT summary, subscale and treatment satisfaction scores were observed at 12 months with CBA vs AAD (all P <0.05). At 12 months, the mean adjusted difference in the AFEQT summary score was 9.9 points higher in the CBA group (95% CI: 5.5 -14.2, P <0.001). Clinically important improvements in the SF-36 physical and mental component scores were observed at 12 months in both groups, with no significant between group differences at this timepoint. In the CBA vs AAD group, larger improvements in EHRA class were observed at 6, 9 and 12 months (P <0.05) and the incidence rate of symptomatic palpitations was lower (4.6 vs 15.2 days/year post-blanking; IRR: 0.30, P <0.001). CONCLUSIONS: In patients with symptomatic AF, first-line CBA was superior to AAD for improving AF-specific QoL and symptoms. TRIAL REGISTRATION: ClinicalTrials.gov number: NCT01803438.

Dielectric imaging for electrophysiology procedures: The technology, current state, and future potential.

Electroanatomic mapping systems have become an essential tool to guide the identification and ablation of arrhythmic substrate. Recently, a novel guiding system for electrophysiology procedures was introduced that uses dielectric sensing to perform high resolution anatomical imaging. Dielectric imaging systems use electrical fields to differentiate anatomic structures based on their conductivity and permittivity. This technique enables non-fluoroscopic, noncontact mapping of anatomic structures, assessment of pulmonary vein occlusion state during cryoballoon ablation, and has the potential to assess for additional tissue characterization including tissue thickness and tissue type. This article elaborates on the functioning and potential of dielectric imaging systems and provides two cases to illustrate the clinical impact for electrophysiology procedures.

The value of remote care in the reduction of healthcare utilization in implantable cardioverter-defibrillator patients.

BACKGROUND: Minimal evidence is available of the reduction in healthcare utilization of remote care in ICD patients over a longer period of follow-up. OBJECTIVES: This study compared healthcare utilization up to 3 year follow-up in implantable cardioverter-defibrillator (ICD) patients with remote care compared to conventional care. METHODS: We conducted a retrospective cohort study of patients who received a single or dual-chamber ICD or cardiac resynchronization therapy-defibrillator (CRT-D) between 2016 and 2018. Patients with remote care and patients were compared with patients with received conventional care (control group). The primary endpoint was a composite of cardiac follow-up visits, ICD follow-up visits, telephone consultations, emergency department (ED) visits and hospital admissions and was defined as total healthcare utilization. The secondary endpoints were the individual care activities and one-year all-cause mortality. RESULTS: A total of 497 patients were included in the study, of which 299 patients were allocated to the remote care and 198 patients to the control group. Mean follow-up was 815 ± 279 days. Remote care was associated with a significantly lower rate of adjusted total healthcare utilization in comparison to the control group that sustained for 3 subsequent follow-up years (IRR = 0.78, 95% CI [0.67 to 0.92], p < .01). One-year all-cause mortality was similar between the remote care and control group (respectively 3.0% vs. 5.5%, p = .29). CONCLUSIONS: Compared to the standard follow-up of in-office care, a remote care program was associated with a sustained lower rate of planned and unplanned healthcare utilization up to 3 subsequent years after ICD/CRT-D implantation.

Improving clinical outcomes and patient satisfaction among patients with coronary artery disease: an example of enhancing regional integration between a cardiac centre and a referring hospital.

BACKGROUND: Value-based healthcare (VBHC) is a promising strategy to increase patient value. For a successful implementation of VBHC, intensive collaborations between organizations and integrated care delivery systems are key conditions. Our aim was to evaluate the effects of a pilot study regarding enhancing regional integration between a cardiac centre and a referring hospital on patient-relevant clinical outcomes and patient satisfaction. METHODS: The study population consisted of a sample of patients treated for coronary artery disease by use of a coronary artery bypass graft (CABG) or a percutaneous coronary intervention between 2011 and 2016. Since 2013, the two hospitals have implemented different interventions to improve clinical outcomes and the degree of patient satisfaction, e.g. improvement of communication, increased consultant capacity, introduction of outpatient clinic for complex patients, and improved guideline adherence. To identify intervention effects, logistic regression analyses were conducted. Patients' initial conditions, like demographics and health status, were included in the model as predictors. Clinical data extracted from the electronic health records and the hospitals' cardiac databases as well as survey-based data were used. RESULTS: Our findings indicate a non-significant increase of event-free survival of patients treated for coronary artery disease between 2014 and 2016 compared to patients treated between 2011 and 2013 (97.4% vs. 96.7% respectively). This non-significant improvement over time has led to significant better outcomes for patients referred from the study referring hospital compared to patients referred from other hospitals. The level of patient satisfaction (response rate 32.2%; 216 out of 669) was improved and reached statistically significant higher scores regarding patient information and education (p = .013), quality of care (p = .007), hospital admission and stay (p = .032), personal contact with the physician (p = .024), and total impression (p = .007). CONCLUSIONS: This study shows a promising effect of regional integration. An intensified collaboration in the care chain, organized in a structured manner between a cardiac centre and a referring hospital and aiming at high quality, resulted in successful improvement of clinical outcomes and degree of patient satisfaction. The applied method may be used as a starting point of regional integration with other referring hospitals. We encourage others to organize the whole care chain to continuously improve patient-relevant outcomes and patient satisfaction. TRIAL REGISTRATION: ISRCTN11311830. Registered 01 October 2018 (retrospectively registered).

Adapting detection sensitivity based on evidence of irregular sinus arrhythmia to improve atrial fibrillation detection in insertable cardiac monitors.

Aims: Intermittent change in p-wave discernibility during periods of ectopy and sinus arrhythmia is a cause of inappropriate atrial fibrillation (AF) detection in insertable cardiac monitors (ICM). To address this, we developed and validated an enhanced AF detection algorithm. Methods and results: Atrial fibrillation detection in Reveal LINQ ICM uses patterns of incoherence in RR intervals and absence of P-wave evidence over a 2-min period. The enhanced algorithm includes P-wave evidence during RR irregularity as evidence of sinus arrhythmia or ectopy to adaptively optimize sensitivity for AF detection. The algorithm was developed and validated using Holter data from the XPECT and LINQ Usability studies which collected surface electrocardiogram (ECG) and continuous ICM ECG over a 24-48 h period. The algorithm detections were compared with Holter annotations, performed by multiple reviewers, to compute episode and duration detection performance. The validation dataset comprised of 3187 h of valid Holter and LINQ recordings from 138 patients, with true AF in 37 patients yielding 108 true AF episodes ≥2-min and 449 h of AF. The enhanced algorithm reduced inappropriately detected episodes by 49% and duration by 66% with <1% loss in true episodes or duration. The algorithm correctly identified 98.9% of total AF duration and 99.8% of total sinus or non-AF rhythm duration. The algorithm detected 97.2% (99.7% per-patient average) of all AF episodes ≥2-min, and 84.9% (95.3% per-patient average) of detected episodes involved AF. Conclusion: An enhancement that adapts sensitivity for AF detection reduced inappropriately detected episodes and duration with minimal reduction in sensitivity.

Acute cardioversion vs a wait-and-see approach for recent-onset symptomatic atrial fibrillation in the emergency department: Rationale and design of the randomized ACWAS trial.

BACKGROUND: Current standard of care for patients with recent-onset atrial fibrillation (AF) in the emergency department aims at urgent restoration of sinus rhythm, although paroxysmal AF is a condition that resolves spontaneously within 24 hours in more than 70% of the cases. A wait-and-see approach with rate-control medication only and when needed cardioversion within 48 hours of onset of symptoms is hypothesized to be noninferior, safe, and cost-effective as compared with current standard of care and to lead to a higher quality of life. DESIGN: The ACWAS trial (NCT02248753) is an investigator-initiated, randomized, controlled, 2-arm noninferiority trial that compares a wait-and-see approach to the standard of care. Consenting adults with recent-onset symptomatic AF in the emergency department without urgent need for cardioversion are eligible for participation. A total of 437 patients will be randomized to either standard care (pharmacologic or electrical cardioversion) or the wait-and-see approach, consisting of symptom reduction through rate control medication until spontaneous conversion is achieved, with the possibility of cardioversion within 48 hours after onset of symptoms. Primary end point is the presence of sinus rhythm on 12-lead electrocardiogram at 4 weeks; main secondary outcomes are adverse events, total medical and societal costs, quality of life, and cost-effectiveness for 1 year. CONCLUSIONS: The ACWAS trial aims at providing evidence for the use of a wait-and-see approach for patients with recent-onset symptomatic AF in the emergency department.

Mapping for Acute Transvenous Phrenic Nerve Stimulation Study (MAPS Study).

BACKGROUND: Central sleep apnea syndrome, correlated with the occurrence of heart failure, is characterized by periods of insufficient ventilation during sleep. This acute study in 15 patients aims to map the venous system and determine if diaphragmatic movement can be achieved by phrenic nerve stimulation at various locations within the venous system. METHODS: Subjects underwent a scheduled catheter ablation procedure. During the procedural waiting time, one multielectrode electrophysiology catheter was subsequently placed at the superior and inferior vena cava and the junctions of the left jugular and left brachiocephalic vein and right jugular and right brachiocephalic vein, for phrenic nerve stimulation (1-2 seconds ON/2-3 seconds OFF, 40 Hz, pulse width 210 µs). Diaphragmatic movement was assessed manually and by a breathing mask. During a follow-up assessment between 2 and 4 weeks postprocedure, occurrence of adverse events was assessed. RESULTS: In all patients diaphragmatic movement was induced at one or more locations using a median threshold of at least 2 V and maximally 7.5 V (i.e., e 3.3 mA, 14.2 mA). The lowest median current to obtain diaphragmatic stimulation without discomfort was found for the right brachiocephalic vein (4.7 mA). In 12/15 patients diaphragmatic movement could be induced without any discomfort, but in three patients hiccups occurred. CONCLUSION: Diaphragmatic stimulation from the brachiocephalic and caval veins is feasible. Potential side effects should be eliminated by adapting the stimulation pattern. This information could be used to design a catheter, combining cardiac pacing with enhancing diaphragm movement during a sleep apnea episode.

Low rate of asymptomatic cerebral embolism and improved procedural efficiency with the novel pulmonary vein ablation catheter GOLD: results of the PRECISION GOLD trial.

AIMS: This prospective, multicentre study (PRECISION GOLD) evaluated the incidence of asymptomatic cerebral embolism (ACE) after pulmonary vein isolation (PVI) using a new gold multi-electrode radiofrequency (RF) ablation catheter, pulmonary vein ablation catheter (PVAC) GOLD. Also, procedural efficiency of PVAC GOLD was compared with ERACE. The ERACE study demonstrated that a low incidence of ACE can be achieved with a platinum multi-electrode RF catheter (PVAC) combined with procedural manoeuvres to reduce emboli. METHODS AND RESULTS: A total of 51 patients with paroxysmal atrial fibrillation (AF) (age 57 ± 9 years, CHA2DS2-VASc score 1.4 ± 1.4) underwent AF ablation with PVAC GOLD. Continuous oral anticoagulation using vitamin K antagonists, submerged catheter introduction, and heparinization (ACT ≥ 350 s prior to ablation) were applied. Cerebral magnetic resonance imaging (MRI) scans were performed within 48 h before and 16-72 h post-ablation. Cognitive function assessed by the Mini-Mental State Exam at baseline and 30 days post-ablation. New post-procedural ACE occurred in only 1 of 48 patients (2.1%) and was not detectable on MRI after 30 days. The average number of RF applications per patient to achieve PVI was lower in PRECISION GOLD (20.3 ± 10.0) than in ERACE (28.8 ± 16.1; P = 0.001). Further, PVAC GOLD ablations resulted in significantly fewer low-power (<3 W) ablations (15 vs. 23%, 5 vs. 10% and 2 vs. 7% in 4:1, 2:1, and 1:1 bipolar:unipolar energy modes, respectively). Mini-Mental State Exam was unchanged in all patients. CONCLUSION: Atrial fibrillation ablation with PVAC GOLD in combination with established embolic lowering manoeuvres results in a low incidence of ACE. Pulmonary vein ablation catheter GOLD demonstrates improved biophysical efficiency compared with platinum PVAC. TRIAL REGISTRATION: ClinicalTrials.gov NCT01767558.

Continuous Cardiac Monitoring around Atrial Fibrillation Ablation: Insights on Clinical Classifications and End Points.

BACKGROUND: Atrial fibrillation (AF) is an arrhythmia that can be difficult to identify and classify with short-term monitoring. However, current standard of practice requires only short-term monitoring to determine AF classifications and identify symptom-arrhythmia correlations prior to AF ablation procedures. Insertable cardiac monitors (ICMs) offer continuous arrhythmia monitoring, which could lead to a more accurate measurement of AF burden than standard of practice. METHODS: This analysis focused on 121 patients enrolled in the LINQ Usability Study indicated for an AF ablation. Patients were followed for up to 1 year after ICM insertion. Clinical AF classifications were made by physicians prior to ICM implantation based on available clinical information. Device-detected AF burden and maximum daily burden were collected from device interrogations and remote transmissions. Device AF classifications were determined by categorizing the AF burden based on guidelines. RESULTS: Agreement between clinical and device AF classifications preablation was poor (48.3%, N = 58). The strongest agreement was in the paroxysmal AF group but still was only 61.8%. Furthermore, device-detected preablation AF burden led to the decision to defer AF ablation procedures in 16 (13.2%) patients. The median AF burden in patients with ≥6 months follow-up postablation (n = 71) was reduced from 7.8% (interquartile range [IQR]: 0-32.1%) to 0% (IQR: 0-0.7%). CONCLUSIONS: ICM monitoring to determine AF burden pre- and post-AF ablation may have clinical utility for management of ablation candidates through more accurate AF classification and guiding treatment decisions.

Safety Profile of a Miniaturized Insertable Cardiac Monitor: Results from Two Prospective Trials.

BACKGROUND: Insertable cardiac monitors (ICMs) are used to continuously monitor the patient's electrocardiogram. In response to patient activation or based on automated device algorithms, arrhythmia episodes are stored and automatically transmitted daily to the clinician. Thus, ICMs can be used to diagnose arrhythmias in at-risk patients and in those with symptoms potentially attributable to arrhythmias. The ICM described in this report has undergone a dramatic change in size and method of insertion. METHODS: To evaluate the safety profile of the ICM procedure, we analyzed procedure-related adverse events (AEs) from two separate trials: A controlled, nonrandomized multicenter study (Reveal LINQ(TM) Usability study) and a multicenter registry (Reveal LINQ(TM) Registry) evaluating real-world experience. For the Registry we reported all procedure-related AEs upon occurrence, whereas for the Usability study, we reported events occurring during the first month of follow-up. RESULTS: The Usability study enrolled 151 patients (age 56.6 ± 12.1 years; male 67%) at 16 centers; during follow-up, an infection was observed in 1.3% patients and a procedure-related serious AE (SAE) in 0.7% patients. The Registry enrolled 122 patients (age 61.0 ± 17.8 years; male 47%) at seven centers; during follow-up, an infection was observed in 1.6% patients and a procedure-related SAE in 1.6% patients. CONCLUSIONS: The cumulative experience from a controlled clinical trial and a "real-world" registry demonstrate that the new ICM can be inserted with very low incidence of AEs.