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Dekker L.R.C.,Catharina Hospital | Pokushalov E.,State Research Institute of Circulation Pathology | Sanders P.,University of Adelaide | Lindborg K.A.,Medtronic | And 2 more authors.
PACE - Pacing and Clinical Electrophysiology | Year: 2016

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. © 2016 Wiley Periodicals, Inc.


Mittal S.,Valley Hospital | Sanders P.,University of Adelaide | Pokushalo E.,State Research Institute of Circulation Pathology | Dekker L.,Catharina Hospital | And 7 more authors.
PACE - Pacing and Clinical Electrophysiology | Year: 2015

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 LINQTM Usability study) and a multicenter registry (Reveal LINQTM 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. © 2015 The Authors. Pacing and Clinical Electrophysiology published by Wiley Periodicals, Inc.


PubMed | Medtronic, Catharina Hospital, University of Adelaide, State Research Institute of Circulation Pathology and Elisabethinen University Teaching Hospital
Type: Journal Article | Journal: Heart rhythm | Year: 2015

The Reveal LINQ is a miniaturized insertable cardiac monitor (ICM) with wireless telemetry for remote monitoring of patients with suspected arrhythmias.The primary objective of this study was to evaluate the functionality of the Reveal LINQ system by measuring R-wave sensing and data transmission.The Reveal LINQ Usability Study was a nonrandomized, prospective, multicenter trial. The study enrolled 30 patients with any indication for an ICM. Data were collected at baseline, implantation, and 1-month follow-up visits and through daily wireless transmissions.Thirty patients were enrolled and had a Reveal LINQ device implanted. The mean age was 55 15 years. All patients had successful implantation of the ICM in one of the recommended locations. Ease of implantation procedure was rated as easy or very easy for 90% of implantations. R-wave amplitudes were 0.584 0.325 mV at implantation and 0.596 0.336 mV at 1 month (P = .8). Automatic transmissions were successful 79.5% (69.5%-86.9%) of the time. Transmission failures that caused a delay in data transfer occurred because of incomplete data reception or patients being out of range in 45% and 42% of instances, respectively. For all patients, transmission failures were followed by successful automated or manual transmission of information on a subsequent day. The devices stored 217 arrhythmic episodes during 30 days of follow-up, identified as atrial fibrillation (n = 111), asystole (n = 95), bradycardia (n = 4), fast ventricular tachycardia (n = 1), and ventricular tachycardia ( n = 6). No serious procedure- or system-related adverse events occurred during the 1-month follow-up period.The miniaturized Reveal LINQ ICM supports arrhythmia detection and monitoring, achieving adequate sensing performance without safety issues.URL: http://www.clinicaltrials.gov. Unique identifier: NCT01965899.


PubMed | The Valley Hospital, Elisabethinen University Teaching Hospital, Catharina Hospital, University of Adelaide and 3 more.
Type: Controlled Clinical Trial | Journal: Pacing and clinical electrophysiology : PACE | Year: 2016

Insertable cardiac monitors (ICMs) are used to continuously monitor the patients 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.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.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.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.


PubMed | Medtronic, State Research Institute of Circulation Pathology and Elisabethinen University Teaching Hospital
Type: | Journal: Europace : European pacing, arrhythmias, and cardiac electrophysiology : journal of the working groups on cardiac pacing, arrhythmias, and cardiac cellular electrophysiology of the European Society of Cardiology | Year: 2017

Cardiac arrhythmias following acute myocardial infarction (AMI) can be associated with major adverse cardiovascular events. Data on the real incidence of post-MI arrhythmias are limited. We aimed to determine the rate and burden of cardiac arrhythmias by the use of insertable cardiac monitors (ICM) in patients with preserved left ventricular ejection fraction (LVEF) after AMI.In this prospective observational study, patients with LVEF40% who underwent PCI within 7 days following AMI were enrolled to receive an ICM. Primary outcome was the incidence of new-onset atrial fibrillation (AF) measured by the ICM during a follow-up of 2 years; results: Of 165 consecutive patients with AMI, 50 (30.3%) eligible patients were recruited (mean age 57.88.3, 88% male). During follow-up, AF was the most frequently detected arrhythmia. Twenty-nine (58%, 95% CI: 42-70%) patients developed new-onset AF, with a cumulative rate of all detected arrhythmias of 65%. Median time to the first detected AF episode was 4.8 months and the peak cumulative AF burden was detected between 3 and 6 months. Twenty-seven (93%) out of 29 patients with AF were asymptomatic. Cox regression analysis found that baseline troponin level (hazard ratio [HR] for 1ng/mL increment: 1.03, 95% CI: 1.01-1.06, P=0.01) and CHA2DS2-VASc score of 4 (HR: 11.42, 95% CI: 1.01-129.06, P=0.04) were independent risk factors of new-onset AF post-AMI.AF is a frequent but largely underestimated cardiac arrhythmia after AMI. More rigorous monitoring strategies resulting in crucial medical interventions (e.g. implementation of oral anti-coagulation) are needed.http://www.clinicaltrials.gov. Unique identifier: NCT02492243.


Tanaka H.,University of Pittsburgh | Nesser H.-J.,Elisabethinen University Teaching Hospital | Buck T.,University of Duisburg - Essen | Oyenuga O.,University of Pittsburgh | And 4 more authors.
European Heart Journal | Year: 2010

Aims The Speckle Tracking and Resynchronization (STAR) study used a prospective multi-centre design to test the hypothesis that speckle-tracking echocardiography can predict response to cardiac resynchronization therapy (CRT).Methods and resultsWe studied 132 consecutive CRT patients with class III and IV heart failure, ejection fraction (EF) ≤35, and QRS ≥120 ms from three international centres. Baseline dyssynchrony was evaluated by four speckle tracking strain methods; radial, circumferential, transverse, and longitudinal (≥130 ms opposing wall delay for each). Pre-specified outcome variables were EF response and three serious long-term events: death, transplant, or left ventricular assist device. Of 120 patients (91) with baseline dyssynchrony data, both short-axis radial strain and transverse strain from apical views were associated with favourable EF response 7 ± 4 months and long-term outcome over 3.5 years (P < 0.01). Radial strain had the highest sensitivity at 86 for predicting EF response with a specificity of 67. Serious long-term unfavourable events occurred in 20 patients after CRT, and happened three times more frequently in those who lacked baseline radial or transverse dyssynchrony than in patients with dyssynchrony (P < 0.01). Patients who lacked both radial and transverse dyssynchrony had unfavourable clinical events occur in 53, in contrast to events occurring in 12 if baseline dyssynchrony was present (P < 0.01). Circumferential and longitudinal strains predicted response when dyssynchrony was detected, but failed to identify dyssynchrony in one-third of patients who responded to CRT. Conclusion Dyssynchrony by speckle-tracking echocardiography using radial and transverse strains is associated with EF response and long-term outcome following CRT. © 2010 The Author.


Purerfellner H.,Elisabethinen University Teaching Hospital | Stollberger C.,Krankenanstalt Rudolfstiftung | Finsterer J.,Krankenanstalt Rudolfstiftung
Acta Cardiologica | Year: 2011

Objective: Meningo-encephalitis as a complication of an atrio-oesophageal fistula (AEF) after left atrial radiofrequency ablation (RFA) has been only rarely reported. Case report: A 49-year-old man with persisting atrial fibrillation and oral anticoagulation underwent RFA without initial complication. Four weeks after the procedure, however, fever, emesis, and confusion occurred. Clinical neurologic examination revealed somnolence, partial disorientation, psychomotor agitation, and athetotic movements of the upper limbs. CSF-investigations revealed 100/3 granulocytes and MR meningeal enhancement and multiple parenchymal enhancing spots. After haematemesis, seizure, and resuscitation, an AEF was detected by the third gastroscopy and confirmed by thoracic CT. Because of the septic state surgeons refused to close the fistula. The patient died 10 days after the clinical onset of meningo-encephalitis from cerebral oedema despite adequate antibiotic treatment. Conclusions: An AEF after RFA may initially manifest as septic meningo-encephalitis, even after a four-week symptom-free interval. Manipulations within the oesophagus after diagnosis of an AEF are contraindicated. The procedure of choice to diagnose an AEF is thoracic CT with contrast medium. Surgical closure of the fistula should be tried immediately after diagnosis despite sepsis.


Charitos E.I.,University of Lübeck | Purerfellner H.,Elisabethinen University Teaching Hospital | Glotzer T.V.,Hackensack University Medical Center | Ziegler P.D.,Medtronic Inc.
Journal of the American College of Cardiology | Year: 2014

Objectives This study aimed to identify how accurately the current clinical atrial fibrillation (AF) classifications reflect its temporal persistence. Background Clinical classification of AF is employed to communicate its persistence, to select appropriate therapies, and as inclusion criterion for clinical trials. Methods Cardiac rhythm histories of 1,195 patients (age 73.0 ± 10.1 years, follow-up: 349 ± 40 days) with implantable devices were reconstructed and analyzed. Patients were classified as having paroxysmal or persistent AF by physicians at baseline in accordance with current guidelines. AF burden, measured as the proportion of time spent in AF, was obtained from the device. Additionally we evaluated the agreement between clinical and device-derived AF classifications. Results Patients within the same clinical class were highly heterogeneous with regards to AF temporal persistence. Agreement between the clinical AF classification and the objective device-derived assessments of AF temporal persistence was poor (Cohen's kappa: 0.12 [95% CI: 0.05 to 0.18]). Patient characteristics influenced the clinical decision to classify AF as paroxysmal or persistent. Higher ejection fraction (odds ratio: 0.97/per unit [95% CI: 0.95 to 0.98/per unit]; p < 0.0001) and presence of coronary artery disease (odds ratio: 0.53 [95% CI: 0.32 to 0.88]; p = 0.01) were independently associated with a lower probability of being classified as persistent AF for the same AF burden level. Conclusions The currently used clinical AF classifications poorly reflect AF temporal persistence. Patient characteristics significantly influence the physician's classification of AF. Patients classified in identical clinical categories may be inherently heterogeneous with regard to AF temporal persistence. Further study is required to determine if patient selection on the basis of objective criteria derived from rigorous AF monitoring can improve reported outcomes and better identify responders and non-responders to treatments. (OMNI Study-Assessing Therapies in Medtronic Pacemaker, Defibrillator, and Cardiac Resynchronization Therapy Devices; NCT00277524; TRENDS: A Prospective Study of the Clinical Significance of Atrial Arrhythmias Detected by Implanted Device Diagnostics; NCT00279981). © 2014 by the American College of Cardiology Foundation. Published by Elsevier Inc.


Nolz R.,Medical University of Vienna | Gschwendtner M.,Elisabethinen University Teaching Hospital | Julg G.,Elisabethinen University Teaching Hospital | Plank C.,Medical University of Vienna | And 6 more authors.
European Journal of Radiology | Year: 2012

Purpose: To compare perioperative and follow-up outcomes of symptomatic versus asymptomatic patients following endovascular repair of anastomotic pseudoaneurysms (APAs) of the abdominal aorta and iliac arteries. Methods: We retrospectively evaluated 17 patients (two women), with a mean age of 66.2 years (range 30-83 years). Endovascular treatment was performed in ten symptomatic, and seven asymptomatic patients electively. Data included technical success, perioperative (within 30 days) mortality and morbidity, as well as stent graft-related complications, reinterventions, and survival in follow-up. Results: Bifurcated (n = 13), aortomonoiliac (n = 3) endoprosthesis and one aortic cuff were implanted with a primary technical success rate of 100%. The overall in-hospital mortality and morbidity rate was 11.8% and 35.3%. The mean survival was 36.5 (range 0-111) months. There was a clear trend toward a lower overall survival within hospital and at one and three years for symptomatic patients compared to asymptomatic patients. (47.7 (CI: 0-138.8) versus 52.6 (CI: 28.5-76.8) months (p = 0.274)). During follow-up, late stent graft related complications were observed in six patients (35.3%) necessitating eight endovascular reinterventions. Additional three patients with primary fistulas between the APA and the intestine were treated by late surgical revision. Conclusion: Endovascular therapy of APAs represents a considerable alternative to open surgical repair. Short proximal anchoring zones still pose a risk for endoleaks and unintentional overstenting of side branches with commercially available devices, but this might be overcome by use of fenestrated and branched stent grafts in elective cases. © 2011 Elsevier Ireland Ltd. All rights reserved.

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