Effect of concomitant Renal DeNervation and cardiac ablation on Atrial Fibrillation recurrence - RDN+AF study.

BACKGROUND: Renal denervation (RDN) can reduce cardiac sympathetic activity maintained by arterial hypertension (aHT). Its potential antiarrhythmic effect on rhythm outcome in patients with multi-drug resistant aHT undergoing catheter ablation for atrial fibrillation (AF) is unclear. METHODS: The RDN+AF study was a prospective, randomized, two-center trial. Patients with paroxysmal or persistent AF and uncontrolled aHT (mean systolic 24-h ambulatory BP > 135 mmHg) despite taking at least three antihypertensive drugs were enrolled. Patients were 1:2 randomized to either RDN+AF ablation or AF-only ablation. Primary endpoint was freedom from any AF episode > 2 min at 12 months assessed by implantable loop recorder (ILR) or 7d-holter electrocardiogram. Secondary endpoints included rhythm outcome at 24 months, blood pressure control, periprocedural complications, and renovascular safety. RESULTS: The study randomized 61 patients (mean age 65 ± 9 years, 53% men). At 12 months, RDN+AF patients tended to have a greater decrease in ambulatory BPs but did not reach statistical significance. No differences in rhythm outcome were observed. Freedom from AF recurrence in the RDN+AF and AF-only group measured 61% versus 53% p = .622 at 12 months and 39% versus 47% p = .927 at 24 months, respectively. Periprocedural complications occurred in 9/61 patients (15%). No patient died. CONCLUSION: Among patients with multidrug-resistant aHT and paroxysmal or persistent AF, concomitant RDN+AF ablation was not associated with better blood pressure control or rhythm outcome in comparison to AF-only ablation and medical therapy.

Magnetic resonance imaging-guided conventional catheter ablation of isthmus-dependent atrial flutter using active catheter imaging.

Background: Interventional cardiac magnetic resonance (iCMR) has been established as a radiation-free alternative compared to standard fluoroscopy-guided catheter ablation for cavotricuspid isthmus (CTI)-dependent atrial flutter to image anatomy, structural alterations, and further catheter guidance. Objective: The purpose of this study was to explore the safety, feasibility, and efficacy of CTI ablations performed completely in the iCMR suite using active catheter imaging. Methods: Consecutive patients underwent iCMR-guided catheter ablation for CTI-dependent atrial flutter. Procedures were performed in a 1.5-T magnetic resonance (MR) imaging unit with MR-conditional ablation catheters. Catheter guidance was achieved using active catheter imaging via integrated MR receive tip coils. Acute success, periprocedural complications, and short-term follow-up were collected for further analysis. Results: All patients (N = 15; 73% male; median age 70 years; interquartile range [67-82]) achieved acute procedural success without any complication. Median procedural time was 43 minutes [33-58] with median radiofrequency delivery time of 18 minutes [12-26]. Postprocedural lesion visualization scanning was completed in a median of 32 minutes [10-42]. None of the patients with 6-month follow-up had atrial flutter recurrence. Conclusion: In the iCMR suite, CTI-dependent atrial flutter ablation could be achieved safely using active catheter imaging without any complication. It further allows detailed anatomic visualization of the CTI, intraprocedural lesion visualization, and exclusion of pericardial effusion.

Effectiveness of SharpSense™ algorithms in reducing bradycardia and pause detection: real-world performance in Confirm Rx™ insertable cardiac monitor.

PURPOSE: SharpSense™ technology is an upgradable software enhancement introduced to the Abbott Confirm Rx™ insertable cardiac monitor (ICM). This study aims to characterize the real-world performance of SharpSense algorithms by comparing device detected pause and bradycardia episodes before and after the SharpSense upgrade. METHODS: Confirm Rx devices with at least 90 days monitoring each before and after SharpSense upgrade were included in the study. Bradycardia and pause detections and subcutaneous electrocardiograms (SECGs) within 90 days before and after the upgrade were extracted from Merlin.net™ patient care network for evaluation and adjudicated by expert adjudicators. RESULTS: A total of 197 devices were included in the analysis. Devices were implanted for syncope (35.0%), atrial fibrillation (32.5%), cryptogenic stroke (16.8%), and other indications including palpitations (15.7%). The SharpSense upgrade significantly reduced the number of bradycardia detections by 86.8% and pause detections by 93.1%. In adjudicated SECGs, the upgrade significantly reduced false positive (FP) bradycardia episodes by 91.5% and FP pause episodes by 82.8%. The percentage of devices with at least one FP episode was reduced from 39 to 20% for bradycardia and from 52 to 35% for pause. The number of devices with FP rate greater than 1 episode per week was reduced from 23 to 8% for bradycardia and from 39 to 20% for pause. CONCLUSIONS: In this real-world performance evaluation, the algorithms incorporated in SharpSense software upgrade in Confirm Rx ICMs substantially reduced false positive bradycardia and pause detections and the number of transmitted SECGs for clinic review.

Low-Voltage Myocardium-Guided Ablation Trial of Persistent Atrial Fibrillation.

Low-Voltage Myocardium Ablation Trial of Persistent AFWe investigated ablation approaches in 324 patients with persistent AF by comparing ablation with PVI alone and PVI plus individualized SM. Patients had electrocardiogram recordings over 12 months of observation. Recurrent AF was documented in 50% of PVI only and 35% of PVI+SM patients. AEs occurred in six PVI+SM versus three PVI-alone patients.

Diminished PLK2 Induces Cardiac Fibrosis and Promotes Atrial Fibrillation.

[Figure: see text].

Real-world Adoption of Smartphone-based Remote Monitoring Using the Confirm Rx™ Insertable Cardiac Monitor.

While previous generations of insertable cardiac monitors (ICMs) required a bedside monitor for remote monitoring (RM), the Confirm Rx™ ICM (Abbott, Chicago, IL, USA) utilizes Bluetooth®, Wi-Fi/cellular technology, and a smart device to connect to the RM system. We aimed to characterize compliance, connectivity, and event transmission timing with the Confirm Rx™ ICM RM system. The study cohort included American patients who received the Confirm Rx™ ICM with SharpSense™ technology within three months of release (May-July 2019). Compliance with RM was quantified as the proportion of patients registering the patient app on their smart device and transmitting at least once. Connectivity was measured as the median number of days between consecutive transmissions per patient. Event transmission time was measured from episode detection to availability on the Merlin.net™ RM system (Abbott). Time from transmission until review by a clinician was examined. Values for device connectivity, episode transmission timing, and clinician view times were reported as median [first quartile, third quartile]. Of 5,666 patients who received a Confirm Rx™ ICM, 97% registered their patient app and 92% transmitted data at least once. Among those utilizing RM (aged 66 ± 15 years; 49% female), connectivity occurred every 1.5 [1.2, 2.4] days, or 4.7 times per week. Patient-reported symptoms were transmitted to Merlin.net™ within 2.9 [2.1, 3.8] minutes of event onset and viewed by the clinician within 0.9 [0.4, 3.1] days, while device-detected episodes without symptoms were transmitted within 18.5 [11.2, 36.5] hours and then viewed within 0.8 [0.3, 2.5] days. This real-world study demonstrated excellent patient compliance with the smartphone-based RM paradigm enabled by Confirm Rx™, suggesting the suitability of this technology for future cardiac implantable devices.

Left Atrial Isolation and Appendage Occlusion in Patients With Atrial Fibrillation at End-Stage Left Atrial Fibrotic Disease.

[Figure: see text].

Safety and Effectiveness of a Next-Generation Contact Force Catheter: Results of the TactiSense Trial.

OBJECTIVES: The objective of this clinical trial was to evaluate the safety and effectiveness of the TactiCath Contact Force Ablation Catheter, Sensor Enabled (TactiCath SE) (Abbott, Abbott Park, Illinois) for the treatment of drug-refractory, symptomatic paroxysmal atrial fibrillation (PAF). BACKGROUND: Catheter ablation of atrial fibrillation (AF) is an established therapy for the treatment of PAF. Ablation technology is evolving with the primary goals of improving efficacy and safety of the procedure. METHODS: This was a multicenter single-arm trial evaluating a novel ablation catheter for the treatment of PAF. A total of 156 subjects were enrolled at 19 sites in the United States, Europe, and Australia. The primary safety endpoint was the rate of device- or procedure-related serious adverse events occurring within 7 days. The primary effectiveness endpoint was acute success defined as pulmonary vein isolation at 30 min after ablation. Two descriptive endpoints were prospectively captured: 1) 1-year freedom from recurrence of symptomatic AF, atrial flutter (AFL), and atrial tachycardia (AT) lasting ≥30 s without a new or increased dose of Class I/III antiarrhythmic drugs; and 2) 1-year drug-free success defined by the absence of any recurrent AF/AFL/AT lasting ≥30 s without using Class I/III antiarrhythmic drugs. RESULTS: Primary safety events occurred in 4.7% of patients (95% confidence interval [CI]: 2.23% to 8.64%), and the procedure was acutely successful in 98.0% of patients (95% CI: 94.95% to 99.46%). According to Kaplan-Meier estimates at 1 year, 82.2% (95% CI: 74.7% to 87.6%) were free from symptomatic recurrence, and 1-year drug-free success was 68.2% (95% CI: 59.9% to 75.1%). CONCLUSIONS: The TactiCath™ Contact Force Ablation Catheter, Sensor Enabled™ is safe and effective for the treatment of paroxysmal AF.

Left atrial phasic transport function closely correlates with fibrotic and arrhythmogenic atrial tissue degeneration in atrial fibrillation patients: cardiac magnetic resonance feature tracking and voltage mapping.

AIMS: To characterize the association of phasic left atrial (LA) transport function and LA fibrosis guided by multimodality imaging containing cardiac magnetic resonance imaging (CMR) feature tracking and bipolar voltage mapping. METHODS AND RESULTS: Consecutive patients presenting for first-time ablation of atrial fibrillation (AF) were prospectively enrolled. Each patient underwent CMR prior to the ablation procedure. LA phasic indexed volumes (LA-Vi) and emptying fractions (LA-EF) were calculated and CMR feature tracking guided LA wall motion analysis was performed. LA bipolar voltage mapping was carried out in sinus rhythm to find areas of low voltage as a surrogate for fibrosis and arrhythmogenesis. One hundred and sixty-eight patients were enrolled. Low-voltage areas (LVAs) were present in 70 patients (42%). Contrary to LA volume, CMR based LA-EF [odds ratio (OR) 0.88, 95% confidence interval (CI) 0.80-0.96, P = 0.005] and LA booster pump strain rate (SR) (OR 0.98, 95% CI 0.97-0.99, P = 0.001) significantly predicted presence and extent of LVA in multivariate logistic regression analysis for patients scanned in SR. In receiver operating characteristic analysis, LA-EF <40% carried a sensitivity of 83% and specificity of 76% (area under the curve 0.8; 95% CI 0.71-0.89) to predict presence of LVA. For patients scanned in AF only minimal LA-Vi on CMR (OR: 1.06; 95% CI: 1.02-1.10; P = 0.002) predicted presence of LVA. CONCLUSION: For patients scanned in SR LA-EF and LA booster pump SR are closely linked to the presence and extent of LA LVA.

Left atrial fibrosis predicts left ventricular ejection fraction response after atrial fibrillation ablation in heart failure patients: the Fibrosis-HF Study.

AIMS: Atrial fibrillation (AF) and heart failure (HF) often coexist. Catheter ablation has been reported to restore left ventricular (LV) function but patients benefit differently. This study investigated the correlation between left atrial (LA) fibrosis extent and LV ejection fraction (LVEF) recovery after AF ablation. METHODS AND RESULTS: In this study, 103 patients [64 years, 69% men, 79% persistent AF, LVEF 33% interquartile range (IQR) (25-38)] undergoing first time AF ablation were investigated. Identification of LA fibrosis and selection of ablation strategy were based on sinus rhythm voltage mapping. Continuous rhythm monitoring was used to assess ablation success. Improvement in post-ablation LVEF was measured as primary study endpoint. An absolute increase in post-ablation LVEF ≥10% was defined as 'Super Response'. Left atrial fibrosis was present in 38% of patients. After ablation LVEF increased by absolute 15% (IQR 6-25) (P < 0.001). Left ventricular ejection fraction improvement was higher in patients without LA fibrosis [15% (IQR 10-25) vs. 10% (IQR 0-20), P < 0.001]. An inverse correlation between LVEF improvement and the extent of LA fibrosis was found (R2 = 0.931). In multivariate analysis, the presence of LA fibrosis was the only independent predictor for failing LVEF improvement [odds ratio 7.2 (95% confidence interval 2.2-23.4), P < 0.001]. Echocardiographic 'Super Response' was observed in 55/64 (86%) patients without and 21/39 (54%) patients with LA fibrosis, respectively (P < 0.001). CONCLUSION: Presence and extent of LA fibrosis predict LVEF response in HF patients undergoing AF ablation. The assessment of LA fibrosis may impact prognostic stratification and clinical management in HF patients with AF.

Resource utilization associated with hospital and office-based insertion of a miniaturized insertable cardiac monitor: results from the RIO 2 randomized US study.

Background: Previous studies support operational benefits when moving insertable cardiac monitor (ICM) insertions outside the cardiac catheterization/electrophysiology laboratories, but this has not been directly assessed in a randomized trial or when the procedure is specifically moved to the office setting. To gain insight, the RIO 2 US study collected resource utilization and procedure time intervals for ICM insertion in-office and in-hospital and these data were used to calculate costs associated with staff time and supply use in each setting.Methods and results: The Reveal LINQ In-Office 2 US study (randomized [1:1], multicenter, unblinded) included 482 patients to undergo insertion of the ICM in-hospital (in an operating room or CATH/EP laboratory) (n = 251) or in-office (n = 231). Detailed information on resource utilization was collected prospectively by the study and used to compare resource utilization and procedure time intervals during ICM insertion procedures performed in-office vs. in-hospital. In addition, costs associated with staff time and supply use in each setting were calculated retrospectively. Total visit duration (check-in to discharge) was 107 min shorter in-office vs. in-hospital (95% CI = 97-116 min; p < 0.001). Patient preparation and education in-office were more likely to occur in the same room as the procedure, compared with in-hospital (91.6% vs. 34.2%, p < 0.001 and 87.3% vs. 22.1%, p < 0.001, respectively). There was a reduction in registered nurse and cardiovascular/operating room technologist involvement in-office, accompanied by higher physician and medical assistant participation. Overall staff time spent per case was 75% higher in-hospital, leading to 50% higher staffing costs compared to in-office.Conclusions: ICM insertion in a physician's office vs. a hospital setting resulted in reduced patient visit time and reduced overall staff time, with a consequent reduction in staffing costs. Clinical trial registration: ClinicalTrials.gov NCT02395536.

Electrophysiological findings during atrial fibrillation reablation: Extending from pulmonary vein reconnection to sequential bipolar voltage map information.

BACKGROUND: Left atrial substrate modification targeting low voltage zones (LVZ) is an ablation strategy that-in addition to pulmonary vein (PV) isolation-tries to eliminate arrhythmogenic mechanisms harbored in such tissue. Electrophysiological findings at reablation include (a) PV reconnection, (b) reconnection over previous substrate ablation, and (c) de-novo LVZ. OBJECTIVE: To study, prevalence and contribution of these arrhythmogenic electrophysiological entities in patients with atrial fibrillation (AF) recurrences. METHODS: Consecutive patients with highly symptomatic AF undergoing index and reablation were included (n = 113). In all patients' PV reconnection, reconnection over previous substrate ablation and spontaneous de-novo LVZ were quantitatively assessed and integrated into an individual reablation strategy. Follow-up was based on continuous device monitoring. RESULTS: At re-do procedure, 45 out of 113 (39.8%) patients showed PV reconnection as the only electrophysiological abnormality. Reconduction over previous lines was the only electrophysiological abnormality in 8 out of 113 (7.1%) patients. Spontaneous de-novo LVZ was the only electrophysiological abnormality in 12 out of 113 (10.6%) patients. Combined findings of PV reconnection, line reconduction, and/or spontaneous de-novo LVZ were seen in 40 out of 113 (35.4%) patients. No detectable electrophysiological abnormality was observed in 8 out of 113 (7.1%) patients. In univariate analysis, none of the tested electrophysiological characteristics independently predicted the outcome after re-do. CONCLUSIONS: In patients undergoing reablation, we could show that reconduction over previous substrate ablation as well as the development of new low voltage areas are frequent findings besides classical PV reconnection-without a clear leading cause for recurrences. These findings impact reablation strategies as well as the strategic focus during index procedures.

A collective European experience with left atrial appendage suture ligation using the LARIAT+ device.

AIMS: We report the collective European experience of percutaneous left atrial appendage (LAA) suture ligation using the recent generation LARIAT+ suture delivery device. METHODS AND RESULTS: A total of 141 patients with non-valvular atrial fibrillation and contraindication to oral anticoagulation (OAC), thrombo-embolic events despite OAC or electrical LAA isolation were enrolled at seven European hospitals to undergo LAA ligation. Patients were followed up by clinical visits and transoesophageal echocardiography (TOE) following LAA closure. Left atrial appendage ligation was completed in 138/141 patients (97.8%). Three patients did not undergo attempted deployment of the LARIAT device due to pericardial adhesion after previous epicardial ventricular tachycardia ablation (n = 1), a pericardial access-related complication (n = 1), and multiple posterior LAA lobes (n = 1). Serious 30-day procedural adverse events occurred in 4/141 patients (2.8%). There were two device-related LAA perforations (1.4%) not resulting in any corrective intervention as the LAA was completely sealed with the LARIAT. Minor adverse events occurred in 19 patients (13.5%), including two pericardial effusions due to procedure-related pericarditis requiring pericardiocentesis. Transoesophageal echocardiography was performed after LAA ligation in 103/138 patients (74.6%) after a mean of 181 ± 72 days. Complete LAA closure was documented in 100 patients (97.1%). Two patients (1.8% of patients with follow-up) experienced a transient ischaemic attack at 4 and 7 months follow-up, although there was no leak observed with TOE. There were two deaths during long-term follow-up which were both not device related. CONCLUSION: Initial experience with the LARIAT+ device demonstrates feasibility of LAA exclusion. Further larger prospective studies with longer follow-up are warranted.

Role of inducibility and its dynamic change in the outcome of catheter ablation of atrial fibrillation: a single center prospective study.

BACKGROUND: The role of atrial arrhythmia inducibility as an endpoint of catheter ablation of atrial fibrillation (AF) has been a controversial subject in many studies. Our goal is to evaluate the significance of inducibility, the impact of multiple sites or protocols of stimulation or the change in inducibility status in a prospective study including patients with AF undergoing first catheter ablation. METHODS: We studied 170 consecutive patients with AF (62.9% paroxysmal) undergoing catheter ablation. All patients underwent two separate stimulation protocols before and after the ablation from the coronary sinus ostium and the left atrial appendage: burst pacing at 300, 250, 200 milliseconds (or until refractoriness) for 10 seconds and ramp decrementing from 300 to 200 milliseconds in increments of 10 milliseconds every three beats for 10 seconds. Inducibility was defined as any sustained AF or organized atrial tachycardia (AT) lasting >30 seconds. RESULTS: We had AF/AT inducibility in 55 patients at baseline compared to 36 following ablation. After a mean of 41, 3 months follow-up, 115 patients were free of AF. Inducibility before or after the ablation or change in inducibility status did not influence AF recurrence. There were no significant differences regarding paroxysmal or persistent patients with AF. CONCLUSIONS: Non-inducibility of atrial arrhythmia or change in inducibility status following pulmonary vein (PV) isolation and substrate modification are not associated with long-term freedom from recurrent arrhythmia. Therefore, the use of induction of an endpoint in AF ablation is limited.

Establishment of an automated patch-clamp platform for electrophysiological and pharmacological evaluation of hiPSC-CMs.

Human induced pluripotent stem cell-derived cardiomyocytes (hiPSC-CMs) have evolved into widely used and reliable cell sources for modeling cardiovascular channelopathies and for drug safety pharmacology. However, the electrophysiological and pharmacological applications of hiPSC-CMs are hampered by manual patch-clamp technique, which is labor-intensive and generates low output. The automated patch-clamp technique is showing potential to overcome this problem. Here, we describe a new dissociation method, with which we can harvest a vast number of single relaxed hiPSC-CMs with smooth membrane suited for automated patch-clamp. Using the automated whole-cell patch-clamp technology, we report a high success rate for cell capture and whole-cell access (around 70%). We are able to identify and record several currents and paced action potentials (APs) with different success rates, including Na+ current (INa), L-type Ca2+ current (ICaL), two specific K+ currents, the transient outward K+ current (Ito) and the inward rectifier K+ current (IK1). Moreover, we successfully applied dynamic current-clamp to virtually increase IK1 for AP recordings. Our study suggests that automated patch-clamp technology could be used to investigate the relevant ionic currents and APs in hiPSC-CMs. The combination of automated patch-clamp and hiPSC-CM technologies promises a wide range of applications in the future.

Catheter Ablation Versus Best Medical Therapy in Patients With Persistent Atrial Fibrillation and Congestive Heart Failure: The Randomized AMICA Trial.

BACKGROUND: Optimal treatment of patients with persistent atrial fibrillation (AF) and heart failure (HF) with reduced left ventricular ejection fraction (LVEF) and an indication for internal defibrillator therapy is controversial. METHODS: Patients with persistent/longstanding persistent AF and LVEF ≤35% were randomly allocated to catheter ablation of AF or best medical therapy (BMT). The primary study end point was the absolute increase in LVEF from baseline at 1 year. Secondary end points included 6-minute walk test, quality-of-life, and NT-proBNP (N-terminal pro-brain natriuretic peptide). Pulmonary vein isolation was the primary ablation approach; BMT comprised rate or rhythm control. All patients were discharged after index hospitalization with a cardioverter-defibrillator or cardiac resynchronization therapy defibrillator implanted. The study was terminated early for futility. RESULTS: Of 140 patients (65±8 years, 126 [90%] men) available for the end point analysis, 68 and 72 patients were assigned to ablation and BMT, respectively. At 1 year, LVEF had increased in ablation patients by 8.8% (95% CI, 5.8%-11.9%) and in BMT patients by 7.3% (4.3%-10.3%; P=0.36). Sinus rhythm was recorded on 12-lead electrocardiograms at 1 year in 61/83 ablation patients (73.5%) and 42/84 BMT patients (50%). Device-recorded AF burden at 1 year was 0% or maximally 5% of the time in 28/39 ablation patients (72%) and 16/36 BMT patients (44%). There was no difference in secondary end point outcome between ablation patients and BMT patients. CONCLUSIONS: The AMICA trial (Atrial Fibrillation Management in Congestive Heart Failure With Ablation) did not reveal any benefit of catheter ablation in patients with AF and advanced HF. This was mainly because of the fact that at 1 year, LVEF increased in ablation patients to a similar extent as in BMT patients. The effect of catheter ablation of AF in patients with HF may be affected by the extent of HF at baseline, with a rather limited ablation benefit in patients with seriously advanced HF. CLINICAL TRIAL REGISTRATION: URL: https://www.clinicaltrials.gov. Unique identifier: NCT00652522.

Atrial high-rate episodes: prevalence, stroke risk, implications for management, and clinical gaps in evidence.

Self-terminating atrial arrhythmias are commonly detected on continuous rhythm monitoring, e.g. by pacemakers or defibrillators. It is unclear whether the presence of these arrhythmias has therapeutic consequences. We sought to summarize evidence on the prevalence of atrial high-rate episodes (AHREs) and their impact on risk of stroke. We performed a comprehensive, tabulated review of published literature on the prevalence of AHRE. In patients with AHRE, but without atrial fibrillation (AF), we reviewed the stroke risk and the potential risk/benefit of oral anticoagulation. Atrial high-rate episodes are found in 10-30% of AF-free patients. Presence of AHRE slightly increases stroke risk (0.8% to 1%/year) compared with patients without AHRE. Atrial high-rate episode of longer duration (e.g. those >24 h) could be associated with a higher stroke risk. Oral anticoagulation has the potential to reduce stroke risk in patients with AHRE but is associated with a rate of major bleeding of 2%/year. Oral anticoagulation is not effective in patients with heart failure or survivors of a stroke without AF. It remains unclear whether anticoagulation is effective and safe in patients with AHRE. Atrial high-rate episodes are common and confer a slight increase in stroke risk. There is true equipoise on the best way to reduce stroke risk in patients with AHRE. Two ongoing trials (NOAH-AFNET 6 and ARTESiA) will provide much-needed information on the effectiveness and safety of oral anticoagulation using non-vitamin K antagonist oral anticoagulants in patients with AHRE.

Safety of in-hospital insertable cardiac monitor procedures performed outside the traditional settings: results from the Reveal LINQ in-office 2 international study.

BACKGROUND: Historically, the majority of insertable cardiac monitor (ICM) procedures were performed in the cardiac catheterization (cath) lab, electrophysiology (EP) lab, or operating room (OR). The miniaturization of ICMs allows the procedure to be relocated within the hospital without compromising patient safety. We sought to estimate the rate of untoward events associated with procedures performed within the hospital but outside the traditional settings and to characterize resource utilization, procedure time intervals, and physician experience. METHODS: The Reveal LINQ in-Office 2 (RIO 2) International study was a single arm, multicenter, prospective study. Patients indicated for an ICM and willing to undergo device insertion outside the cath/EP lab or OR were eligible and followed for 90 days after insertion. RESULTS: A total of 191 patients (45.5% female aged 63.8 ± 26.9 years) underwent successful Reveal LINQ ICM insertion at 17 centers in Europe, Canada and Australia. The median total visit duration was 106 min (interquartile range [IQR]: 55-61). Patient preparation and patient education accounted for 10 min (IQR: 5-20) and 10 min (IQR: 8-15) of total visit duration, respectively. Preparation and education occurred in the procedure room for 90.6 and 60.2% of patients, respectively. There were no untoward events (0.0, 95% CI: 0.0-2.1%) though four patients presented with procedure-related adverse events that did not require invasive intervention. Physicians rated procedure location as convenient or very convenient. CONCLUSIONS: The Reveal LINQ™ ICM insertion can be safely and efficiently performed in the hospital outside the cath/EP lab or OR. TRIAL REGISTRATION: ClinicalTrials.gov identifier NCT02412488 ; registered on April 9, 2015.

Clinical evaluation of a small implantable cardiac monitor with a long sensing vector.

INTRODUCTION: We conducted this study to show the safety and efficacy of a new implantable cardiac monitor (ICM), the BioMonitor 2 (Biotronik SE & Co. KG; Berlin, Germany), and to describe the arrhythmia detection performance. METHODS: The BioMonitor 2 has an extended sensing vector and is implanted close to the heart. It can transmit up to six subcutaneous electrocardiogram strips by Home Monitoring each day. We enrolled 92 patients with a standard device indication for an ICM in a single-arm, multicenter prospective trial. Patients were followed for 3 months, and 48-h Holter recordings were used to evaluate the arrhythmia detection performance. RESULTS: One patient withdrew consent and in one patient, the implantation failed. Two study device-related serious adverse events were reported, satisfying the primary safety hypothesis. Implantations took 7.4 ± 4.4 min from skin cut to suture. At 1 week, the R-wave amplitude was 0.75 ± 0.53 mV. In the 82 patients with completed Holter recordings, all patients with arrhythmias were correctly identified. False positive detections of arrhythmia were mostly irregular rhythms wrongly detected as atrial fibrillation (episode-based positive predictive value 72.5%). Daily Home Monitoring transmission was 94.9% successful. CONCLUSION: Safety and efficacy of the new device has been demonstrated. The detected R-wave amplitudes are large, leading to a low level of inappropriate detections due to over- or undersensing.