October 2019 | Issue 46
ESC guidelines on supraventricular tachycardias underline the pivotal role of catheter ablation therapy The European Society of Cardiology unveiled guidelines for treatment of supraventricular tachycardia (SVT) on the opening day of its Congress (ESC 2019; 31 August–4 September, Paris, France). Simultaneously published online in the European Heart Journal, the document provides recommendations for all types of SVT, and cements the role of catheter ablation therapy, with a press release from the ESC describing it as “revolutionising care”.
he consensus document is based on an up-todate review of the evidence, and summarises the latest developments and advances since the last ESC guidelines on SVTs in 2003, as well as areas for further research. Although drug therapies for SVTs have not fundamentally changed in the past 16 years, the availability of catheter ablation has led to major changes in clinical practice. The guidelines provide general recommendations for the management of adults with SVT based on the principles of evidence-based medicine, but the authors point out that, because evidence and expert opinions from several countries are included, some antiarrhythmic approaches may not have the approval of governmental regulatory agencies in all countries. In addition, many of the drugs that were recommended previously have not been considered in the 2019 guidelines. Professor Demosthenes Katritsis (Hygeia Hospital, Athens, Greece) is a chairperson of the guidelines taskforce. In the press release, he points out: “Catheter ablation techniques and technology have evolved in a way that we can now offer this treatment modality to most of our patients with SVT.” SVTs have a prevalence of approximately 0.2% in the general population, and women are at twice the risk of men, with those aged ≥65 years at more than five times the risk of younger people. If left untreated, SVTs increase the risk of stroke and affect quality of life. Antiarrhythmic drugs are useful for acute episodes, but have limited value for long-term use, due to relatively low efficacy and related side-effects. Among the concepts that have been revised in the updated guidance are: ■Drug therapy for inappropriate sinus tachycardia and focal atrial tachycardia ■Therapeutic options for acute conversion and anticoagulation of atrial flutter ■Therapy of atrioventricular nodal re-entrant tachycardia (AVNRT) ■ Therapy of antidromic AVNRT and pre-excited atrial fibrillation Josep Brugada, co-chairperson of the guidelines taskforce
■Management of patients with asymptomatic preexcitation ■Diagnosis and therapy of tachycardiomyopathy. SVT is linked with a higher risk of complications during pregnancy, and specific recommendations are provided for pregnant women. All antiarrhythmic drugs should be avoided, if possible, within the first trimester of pregnancy. However, if necessary, some drugs may be used with caution during that period. The guidelines also suggest that, if ablation is necessary during pregnancy, non-fluoroscopic mapping may be used. “Pregnant women with persistent arrhythmias that do not respond to drugs, or for whom drug therapy is contraindicated or not desirable, can now be treated with catheter ablation using new techniques that avoid exposing themselves or their baby to harmful levels of radiation,” says Katritsis. The recommendations provide some key messages. These include: ■Vagal manoeuvres and adenosine are the treatments of choice for the acute therapy of SVT, and may also provide important diagnostic information ■Verapamil is not recommended in wide QRScomplex tachycardia of unknown aetiology ■In all re-entrant and most focal arrhythmias, catheter ablation should be offered as an initial choice to patients, after having explained in detail the potential risks and benefits ■Patients with macro re-entrant tachycardias following atrial surgery should be referred to specialised centres for ablation ■In post-atrial fibrillation (AF) ablation atrial tachycardias (ATs), focal or macro re-entrant, ablation should be deferred for three or more months after AF ablation, when possible ■ Ablate AVNRT, typical or atypical, with lesions in the anatomical area of the nodal extensions, either from the right or left septum ■ AVNRT, typical or atypical, can now Continued on page 2
Driving and ICDs
Risk prediction model Page 12
Maximum-fixed energy shocks are more effective than low-escalating energy shocks for cardioverting AF
A study that compared the use of maximum-fixed energy and low-escalating energy shocks for cardioversion in patients with atrial fibrillation (AF) found that maximum-fixed shocks were significantly more effective at cardioverting AF. No differences were found in any safety endpoints included in the study between patients treated with either method. RESULTS FROM THE study were presented by Anders Sjoerslev Schmidt (Randers Regional Hospital, Randers; Aarhus University, and Aarhus University Hospital, Denmark) in a Hotline Session at the European Society of Cardiology Congress (ESC 2019; 31 August–4 September, Paris, France). He stated: “We found that when using maximumfixed shocks the cardioversion efficacy was 88%, compared to 66% when using a more standard low-escalating approach. This was a 22% absolute difference and statistically significant.” Direct-current cardioversion of AF is one of the most commonly performed clinical procedures in cardiology, emergency, and critical care medicine. However, the 2016 ESC guidelines on the management of AF do not specify which energy levels to use when performing the procedure. Schmidt explained: “It is common practice to use low initial energy shocks with escalating effect, if necessary. This protocol was originally introduced to improve safety in the era of monophasic shocks. Now we more commonly use biphasic shocks for cardioversion, which are more effective than monophasic shocks, and safer in terms of not Continued on page 2
October 2019 | Issue 46
ESC guidelines on supraventricular tachycardias underline the pivotal role of catheter ablation therapy Continued from page 1
be ablated with almost no risk of atrioventricular (AV) block ■Do not use sotalol in patients with SVT ■Do not use flecainide or propafenone in patients with left bundle branch block (LBBB), or ischaemic or structural heart disease ■If a patient undergoes an electrophysiological assessment and is found to have an accessory pathway with high-risk characteristics, catheter ablation should be performed. The guidance also urges physicians to consider tachycardiomyopathy (TCM) in patients with reduced left ventricular function and SVT, and to use ablation as the treatment of choice for TCM due to SVT. AV nodal ablation with subsequent biventricular or His-bundle pacing (“ablate and pace”) should be considered if the SVT cannot be ablated. Gaps in the evidence are highlighted, and include that the exact circuit of AVNRT, which is the most common regular arrhythmia, remains unresolved, the proper management of asymptomatic pre-excitation and strict catheter ablation indications have not been established, and that the genetics of SVT have not been adequately studied. There is evidence for familial forms of AVNRT, atrioventricular re-entrant tachycardia (AVRT), sinus tachycardia, and AT, but data are scarce. The document concludes: “The past decade has witnessed a rapid evolution of ablation equipment and electrode-guiding systems, which has resulted in more controllable and safer procedures. Intracardiac echocardiography, robotic techniques, and sophisticated anatomical navigation systems have been developed, and it is now possible to perform ablation without exposing the operator to radiation and ergonomically unfavourable positions. “New materials for electrodes and other equipment have allowed the concept of a radiation-free electrophysiology laboratory with the use of CMR [cardiac magnetic resonance imaging]. The vision of a fully radiation-free, magnetic laboratory in the future is not science fiction anymore.”
Maximum-fixed energy shocks are more effective than low-escalating energy shocks for cardioverting AF
with high-sensitive troponin I changes), skin redness or burns, and patient-reported discomfort or pain using a visual analogue scale. In all, 276 patients were randomised; 129 to maximum-fixed shocks and 147 to low-escalating shocks. Investigators found that the percentage of patients in sinus rhythm one minute after cardioversion was 88% for those who had received maximum-fixed shocks, compared with 66% for those who had received lowescalating shocks—a statistically significant difference Continued from page 1 of 22% in shock efficiency (95% confidence interval inducing myocardial injury or skin burns. Therefore [CI] 13–32, p<0.001). Similarly, the efficacy to the advantage of the low-escalating approach of discharge—the proportion of patients in sinus rhythm biphasic shocks is now less clear.” four hours after the procedure—was 85% for the Researchers at Randers Regional Hospital in maximum-fixed shock group compared with 63% for Denmark aimed to investigate the use of maximumthe low-escalating shock group, a 22% difference in fixed versus low-escalating energy shocks for cardioversion efficacy (95% CI 12–32, p<0.001). cardioverting AF. In this single-centre study, patients Schmidt said: “The maximum-fixed energy group were randomised 1:1 to undergo cardioversion only needed a median number of one shock to achieve cardioversion compared with a median number of two shocks for the patients treated with low-escalating energy shocks. The average procedure duration was shorter for the maximum-fixed energy group at a median time of 1.9 minutes, with IQR [interquartile range] of 1.5–2.7, compared to 2.2 minutes, with an IQR of 1.7–3, for the low-escalating energy group.” “Importantly,” he continued “there were no major harms reported in this study. The same number of cases of arrhythmia were reported in each group and there was no significant change in high-sensitive troponin I levels after cardioversion. There were no incidents of skin burns in any patients using either low-escalating shocks or and comparable numbers of mild redness maximum-fixed shocks. All shocks were were found in both groups. A comparable delivered using a truncated exponential proportion of patients in each group also waveform with the LifePak 20 device reported any pain or discomfort.” (Physio-Control). The maximum-fixed There were some limitations: the study shocks were at 360J, the maximum only took place in one centre using only setting on the device, while the lowone device, and the physician carrying escalating shock protocol escalated to a out cardioversion was not blinded maximum of 200J (125–150–200J). to the energy level used. Also, acute Patients were eligible for inclusion cardioversions were not included. if they were scheduled for elective Although the study was powered for cardioversion of AF, and ≥18 years old. efficacy rather than safety endpoints, Patients were excluded if they had non- Anders Sjoerslev Schmidt Schmidt noted that “it was very AF arrhythmias or haemodynamically reassuring to see comparable outcomes unstable AF, if they had untreated hyperthyroidism, for all the included safety endpoints.” were pregnant, or had previously been enrolled in the He concluded: “Using maximum-fixed energy trial. shocks can optimise cardioversion efficacy. We The primary endpoint was sinus rhythm one minute would suggest a change in clinical practice to use the after cardioversion. Secondary safety endpoints were maximum energy available rather than the existing cases of arrhythmia, myocardial injury (measured practice of using low-escalation shocks.”
With maximum-fixed energy shocks, the cardioversion efficacy was 88%, compared to 66% with a low-escalating approach.”
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October 2019 | Issue 46
SPONSORED BY ABBOTT
The Advisor™ HD Grid Mapping Catheter, Sensor Enabled™, maps at high resolution and is fast,1 accurate2 and easy-to-use3 The Advisor™ HD Grid Mapping Catheter, Sensor Enabled™ (SE), is a unique mapping catheter that, when used with the EnSite Precision™ Cardiac Mapping System, allows bipole recording of waveforms in both the parallel and perpendicular planes,4 allowing for faster data collection in a given location.1 Cardiac Rhythm News spoke to Dr Kent Nilsson (Medical Director of the Electrophysiology Lab at Piedmont Heart Institute, Athens, Georgia, and Associate Professor of Medicine at Augusta University, Georgia, USA) about his experiences using the system and its advantages over other catheters.
hen asked about his daily practice, Dr Nilsson shared that he primarily performs ablations, treating both simple cases (atrioventricular nodal re-entry tachycardia) and more complex issues such as ischemic ventricular tachycardia (VT). He estimates that about 70% of his patients present with a condition that is difficult to treat. Initially, he tried the Advisor HD Grid Mapping Catheter, SE, for the most complex procedures, but was so impressed by its performance that he moved on to other applications. He explains: “Ischemic VT is typically a very difficult case. We liked the accuracy, the safety and the ability to move the catheter around, and you get a really high definition map. Based on the highly accurate maps generated with the Advisor HD Grid Mapping Catheter, SE, we were able to begin ablation more quickly and terminate the tachycardia rapidly. The benefits brought to the lab with the Advisor HD Grid Mapping Catheter, SE, were a lot more powerful than we thought they would be. Then I deployed it in an atrial fibrillation (AF) case. We started making observations and found that we were seeing a lot of low amplitude potentials that we hadn’t found before.” The catheter consists of 16 electrodes arranged in a 4 × 4 grid. When combined with the software of the EnSite Precision™ Cardiac Mapping System, the design allows mapping of both orthogonal and perpendicular electrocardiogram signals for every bipole. “With traditional linear mapping catheters, if an impulse signal is moving down the electrode you are going to get a really strong signal, whereas if it is moving perpendicular to the electrode you get no signal whatsoever. There may be areas of interest that you would miss as they are low amplitude and perpendicular to a traditional catheter. Oftentimes, these signals are really complex and fractionated, indicating potential ablation sites. With the Advisor HD Grid Mapping Catheter, SE, you are able to acquire an enormous amount of data very quickly and very accurately, and to see things you weren’t able to see before. If you are looking for specific areas of slow conduction in complex atrial flutters, the algorithm automatically chooses the electrogram with the highest amplitude for each pair; you can see the best signal and the resolution is a lot higher. No other catheter does that.” With Advisor HD Grid Mapping Catheter, SE, mapping technology, greater mapping density creates opportunities for rapid,1 accurate2 model creation. “Case times have been cut using the HD Grid,” Dr Nilsson declares. “I have anticipated spending four or five hours on some patients, and finished in 45 minutes. And because you are able to acquire so much data, and the data is more accurate, procedural success goes up.” Dr Nilsson has mapped over 175 cases with the Advisor HD Grid Mapping Catheter, SE, and outlines the main arrhythmias in which he has used it: “One is ventricular tachycardia — either ischemic or nonischemic VTs. The second area it has been really helpful
for is atypical atrial flutters and atrial tachycardias. And third, we routinely use it in AF ablation.” In mapping VTs, the Advisor HD Grid Mapping Catheter, SE, has allowed Dr Nilsson to delineate scar borders and potential ablation sites, as well as identify critical isthmuses: “If the patient is in VT at the time we start the procedure, we are able to map that critical spot a lot faster than with the traditional mapping techniques.” Mapping atypical atrial flutters and atrial tachycardias with the 4 × 4 grid provides a more complete map, he says. “In atrial tachycardia you are looking for a very specific spot that is firing early, and
With the Advisor HD Grid Mapping Catheter, SE, you are able to acquire an enormous amount of data very quickly and very accurately, and to see things you weren’t able to see before.” the grid-like structure rapidly brackets the entire area. You are able to identify the site of early activation much quicker than you would do with a traditional catheter.” Atypical atrial flutters often occur following a previous ablation: “These are some of the most vexing cases. With atypical atrial flutters you are looking for the critical isthmus, for areas where there is slow conduction. The Advisor HD Grid Mapping Catheter,
SE, is phenomenal at identifying it very rapidly.” And for AF, he says: “As more and more people have gained experience with the Advisor HD Grid Mapping Catheter, SE, I think it is catching on as one of the preferred mapping catheters.” He cites four reasons for this. The first according to Dr Nilsson is its pliability: “The Advisor HD Grid Mapping Catheter, SE, is completely floppy; you would have to be pushing really hard to cause any damage.” The second is its ability to detect low amplitude potentials that, Dr Nilsson says, “I don’t think we were picking up before. This isn’t just my observation; other high volume users are seeing the same thing. We just never saw them with traditional spiral catheters. Whether eliminating these potentials translates into improved outcomes has yet to be proven.” Third, its high resolution allows gaps to be identified quickly. Successful treatment of AF depends on closing the gap between pulmonary vein isolation and pulmonary vein reconnection: “In the past, if we picked the site of earliest activation and said, ‘this is where the gap is’, it turns out that it would not be there, it would be to the left or the right of that.” Fourth, and finally, the accuracy2 of the catheter minimizes the amount of ablation required following thorough endocardial substrate mapping. “Finding that critical point to ablate had been really difficult. There were a lot of epicardial tracks that we didn’t know about or appreciate before. Now, you can identify where the epicardial fibres are coming in and get that one particular spot with a single lesion that takes 10 seconds, as opposed to extensive ablation.” He concludes: “The Advisor HD Grid Mapping Catheter, SE, is an incredibly safe diagnostic and mapping catheter. In over 175 cases, I have had no complications attributable to the Advisor HD Grid Mapping Catheter, SE. It moves a lot easier than other catheters, especially manipulating around the left ventricle — it is a great catheter to work with.” For more information about the Advisor™ HD Grid Mapping Catheter, SE, go to https://www.cardiovascular.abbott/us/en/hcp/products/ electrophysiology/advisor-hd-grid.html. References: 1. Abbott. Report on File. 90299533. 2. Abbott. Report on File. 90262900. 3. Abbott. Report on File. 90355919. 4. Abbott. Report on File. 90280703. Refer to important safety information on page 06
Issue 46 | October 2019
Confirm Rx™ ICM allies with SharpSense™ technology and syncs to a smartphone for a superior performance Launched in May 2019 by Abbott, the next-generation Confirm Rx™ insertable cardiac monitor (ICM) has both the CE mark in Europe and Food and Drug Administration clearance in the United States. The Confirm Rx ICM is a small, implantable device that combines smartphone connectivity via Bluetooth® wireless technology with continuous, remote monitoring for fast and accurate diagnosis of unpredictable arrhythmias. Dhanunjaya Lakkireddy (Executive Medical Director, Kansas City Heart Rhythm Institute and Professor of Medicine, University of Missouri, USA) and Simon Beggs (Cardiology Registrar at NHS Scotland and Honorary Lecturer at the University of Glasgow, Glasgow, UK) outlined to Cardiac Rhythm News how recent upgrades to the device have further improved its performance. A MAJOR ADVANCE has been the introduction of SharpSense™ technology, a feature that physicians welcome and that has led to a 97% reduction in the detection of false events of atrial fibrillation (AF), bradycardia and pause episodes.1 SharpSense technology harnesses the power of extra discriminators to improve accuracy. Users can now also print scatterplots for better visualisation of trends in heart rates. In AF, SharpSense technology prevents false detections when P-waves are identified. In bradycardia, SharpSense applies a customized threshold determined by the dynamics of R-, P-, and T-waves from several sensed beats to reject false detections due to undersensing of R-waves. In pause, SharpSense technology not only applies a customized threshold to reject false detections due to undersensing of R-waves but also rejects false detections with patterns indicative of loss of electrode-to-tissue contact. SharpSense technology decreases false positives while maintaining high sensitivity for detecting true episodes, resulting in relative sensitivity of 97.2%, 98.6%, and 98.1% for AF, bradycardia, and pause, respectively.2 Dr Beggs says: “SharpSense technology is an improved sensing algorithm that filters the data and cleans it up. If there are lots of false events detected, then it is more difficult to analyse the data. The SharpSense technology increases physicians’ confidence that alerts from the device are genuine, and in doing so it reduces the workload of running a healthcare clinic or a remote consultation clinic for healthcare providers and physicians.” Dr Lakkireddy agrees: “The sensitivity is definitely better, with less detection of false positives, and the crispness of the electrograms that are seen is also significantly better. Improvements in picking up changes in the beat-to-beat amplitude variability mean that the detection algorithms are much more reliable.” A further
bonus, he points out, is an improved patient experience for his patients, by avoiding unnecessary follow-up and its attendant anxieties. Bluetooth® connectivity also enhances patient and physician experiences. The Confirm Rx™ ICM is the only ICM on
patient privacy, says Dr Beggs: “It is more discreet for the patient to record episodes because they are just using their own mobile phone; they are not drawing attention to themselves, and that can be important to patients.” The implantable nature of the device
True bradycardia episodes are discerned through customized thresholds created by dynamic evaluation of multiple R-waves and P-waves, leading to a relative sensitivity of 98.6%.” the market that syncs to a smartphone via Bluetooth® wireless technology. There is no need for a home-based transmitter or patient activator, and the myMerlin™ mobile app for Confirm Rx ICM is user friendly, is compatible with both Android‡ and Apple‡ devices and has been translated into nearly 40 languages. It helps engage patients in their treatment, and they receive automatic notifications when they miss device checks or scheduled transmissions. Dr Lakkireddy considers the Bluetooth® wireless technology a major advantage: “Patients do not need a separate system to transmit the information, and the ability to do everything through your smartphone is one of the strongest features. I am even able to log on via my smartphone and access patient data; I like that aspect very much.” Bluetooth® connectivity also benefits
also aids compliance — Dr Beggs notes that, unlike wearable technology, it cannot be removed at the patient’s whim. And he believes that patients get a psychological boost from the knowledge that their heart rhythm is being continuously monitored. Feedback from his patients indicates that they are grateful for this and that it allays fears, adding to their quality of life. The Confirm Rx ICM is inserted under the skin in the chest above the heart during a quick, minimally invasive outpatient procedure. Dr Beggs is a “high volume implanter” and says he can insert the device “in a matter of minutes”. “Previously, it was a more significant undertaking, with a bigger device being implanted under the skin. It required stitching and, in some cases, was performed in surgical operating theatres. The implant itself, and the patient coming and going, is a quick and easy
thing to do, and is increasingly being undertaken not only by physicians, but also by cardiac physiologists and trained nurses because it is a much more minor procedural undertaking.” From procedure to follow-up, Confirm Rx ICM is easy to manage. Enrolment and transfer to a follow-up clinic is simple for procedure staff. Clinicians can then customize alerts with the easy-to-use interface. Dr Lakkireddy describes the use of Confirm Rx ICM as “multifaceted” and an “integral part of electrophysiology practice and arrhythmia management”. “We treat the whole breadth of electrophysiology—conduction system abnormalities, sinus node dysfunction, atrioventricular block, left ventricular dysfunction, cardiac arrest, and patients with pacemakers, implantable cardioverter defibrillators and cardiac resynchronization therapy devices. We also have a large population of patients who have syncope, and the Confirm Rx ICM is a very important management tool. It is excellent for patients with polymorphic ventricular tachycardias and non-conductive myocarditis; it uses much better longterm data. And we use it in AF patients to understand the arrhythmia burden while patients are on anti-arrhythmic drugs, and after AF ablation.” He provides an example of where the Confirm Rx ICM helped pinpoint a diagnosis in a 27-year-old male with episodes of self-resolving torsade de pointes while sleeping; the findings led to the identification of Brugada syndrome uncovered by fever. And more accurate data capture also means that unnecessary treatments can be avoided; Dr Lakkireddy details the case of a 17-year-old female patient for whom Confirm Rx ICM demonstrated that there was no longer a need for pacemaker implantation: “The second-generation Confirm Rx ICM is definitely a superior device,” he concludes. References: 1. Abbott. Evaluation of Clinical Impact of Confirm Rx 1.2 Algorithm Enhancements. Document 60098828. April 2019. 2. Abbott. Design Validation Report and Trace Matrix, Insertable Cardiac Monitor (ICM) System DOC 60076435 Rev. E March 2019. Refer to important safety information on page 06 ™ Indicates a trademark of the Abbott group of companies. ‡ Indicates a third party trademark, which is property of its respective owner. Bluetooth and Bluetooth logo are registered trademarks of Bluetooth SIG, Inc.
October 2019 | Issue 46
Abbott Advisor™ HD Grid Mapping Catheter, Sensor Enabled™ Disclaimer Referenced on page 4
One St. Jude Medical Dr., St. Paul, MN 55117 USA, Tel: 1 651 756 2000 Abbott.com CAUTION: This product is intended for use by or under the direction of a physician. Prior to use, reference the Instructions for Use, inside the product carton (when available) or at manuals.sjm.com or eifu.abbottvascular.com for more detailed information on Indications, Contraindications, Warnings, Precautions and Adverse Events. Rx Only United States — Required Safety Information Brief Summary: Prior to using these devices, please review the Instructions for Use for a complete listing of indications, contraindications, warnings, precautions, potential adverse events and directions for use. Indications: The Advisor™ HD Grid Mapping Catheter, Sensor Enabled™, is indicated for multiple electrode electrophysiological mapping of cardiac structures in the heart, i.e., recording or stimulation only. This catheter is intended to obtain electrograms in the atrial and ventricular regions of the heart. Contraindications: The catheter is contraindicated for patients with prosthetic valves and patients with left atrial thrombus or myxoma, or interatrial baffle or patch via transseptal approach. This device should not be used with patients with active systemic infections. The catheter is contraindicated in patients who cannot be anticoagulated or infused with heparinized saline. Warnings: Cardiac catheterization procedures present the potential for significant x-ray exposure, which can result in acute radiation injury as well as increased risk for somatic and genetic effects, to both patients and laboratory staff due to the x-ray beam intensity and duration of the fluoroscopic imaging. Careful consideration must therefore be given for the use of this
catheter in pregnant women. Catheter entrapment within the heart or blood vessels is a possible complication of electrophysiology procedures. Vascular perforation or dissection is an inherent risk of any electrode placement. Careful catheter manipulation must be performed in order to avoid device component damage, thromboembolism, cerebrovascular accident, cardiac damage, perforation, pericardial effusion, or tamponade. Risks associated with electrical stimulation may include, but are not limited to, the induction of arrhythmias, such as atrial fibrillation (AF), ventricular tachycardia (VT) requiring cardioversion, and ventricular fibrillation (VF). Catheter materials are not compatible with magnetic resonance imaging (MRI). Precautions: Maintain an activated clotting time (ACT) of greater than 300 seconds at all times during use of the catheter. This includes when the catheter is used in the right side of the heart. To prevent entanglement with concomitantly used catheters, use care when using the catheter in the proximity of the other catheters. Maintain constant irrigation to prevent coagulation on the distal paddle. Inspect irrigation tubing for obstructions, such as kinks and air bubbles. If irrigation is interrupted, remove the catheter from the patient and inspect the catheter. Ensure that the irrigation ports are patent and flush the catheter prior to re-insertion. Always straighten the catheter before insertion or withdrawal. Do not use if the catheter appears damaged, kinked, or if there is difficulty in deflecting the distal section to achieve the desired curve. Do not use if the catheter does not hold its curve and/or if any of the irrigation ports are blocked. Catheter advancement must be performed under fluoroscopic guidance to minimize the risk of cardiac damage, perforation, or tamponade.
™ Indicates a trademark of the Abbott group of companies. ‡ Indicates a third party trademark, which is property of its respective owner. © 2019 Abbott. All Rights Reserved. 32956-SJM-ADV-0719-0083 | Item approved for global use.
Abbott Confirm Rx™ ICM Disclaimer Referenced on page 5
Abbott One St. Jude Medical Dr., St. Paul, MN 55117 USA, Tel: 1 651 756 2000 Abbott.com Rx Only Brief Summary: Prior to using these devices, please review the Instructions for Use for a complete listing of indications, contraindications, warnings, precautions, potential adverse events and directions for use. Indications: The Confirm Rx™ ICM is indicated for the monitoring and diagnostic evaluation of patients who experience unexplained symptoms such as: dizziness, palpitations, chest pain, syncope, and shortness of breath, as well as patients who are at risk for cardiac arrhythmias. It is also indicated for patients who have been previously diagnosed with atrial fibrillation or who are susceptible to developing atrial fibrillation. The Confirm Rx ICM has not been specifically tested for pediatric use. Contraindications: There are no known contraindications for the insertion of the Confirm Rx ICM. However, the patient’s particular medical condition may dictate whether or not a subcutaneous, chronically inserted device can be tolerated. Adverse Events: Possible adverse events (in alphabetical order) associated with the device include the following: Allergic reaction, Bleeding, Chronic nerve damage, Erosion, Excessive fibrotic tissue growth, Extrusion, Formation of hematomas or cysts, Infection, Keloid formation and Migration. Refer to the User’s Manual for detailed indications, contraindications, warnings, precautions and potential adverse events.
Additional Information: Clinicians must log onto Merlin.net™ Patient Care Network (PCN) to view transmissions from patients’ Confirm Rx ICM. On Merlin.net PCN they can configure transmission schedules and enable or disable features on a patient’s myMerlin™ for Confirm Rx ICM mobile app. Review of transmissions is dependent on the clinician and may not happen immediately following delivery of such transmissions. Limitations: Patients may use their own Apple‡ or Android‡ mobile device to transmit information from their Confirm Rx ICM using the myMerlin for Confirm Rx mobile app. To do so the device must be powered on, app must be installed, Bluetooth® wireless technology enabled and data coverage (cellular or WiFi‡) available. The myMerlin for Confirm Rx mobile app provides periodic patient monitoring based on clinician configured settings. Data is resent if the transmission was not sent successfully. However, there are many internal and external factors that can hinder, delay, or prevent acquisition and delivery of ICM and patient information as intended by the clinician. These factors include: patient environment, data services, mobile device operating system and settings, ICM memory capacity, clinic environment, schedule/configuration changes, or data processing. An Abbott mobile transmitter is available for patients without their own compatible mobile device.
™ Indicates a trademark of the Abbott group of companies. ‡ Indicates a third party trademark, which is property of its respective owner. Bluetooth and Bluetooth logo are registered trademarks of Bluetooth SIG, Inc. © 2019 Abbott. All Rights Reserved. 32956-SJM-CFM-0719-0160 | Item approved for global use.
Issue 46 | October 2019
Individualised home-based education dramatically decreases atrial fibrillation-related hospitalisations and other cardiovascular admissions Personalised education delivered in a home setting significantly reduces hospitalisations in patients with atrial fibrillation (AF). This was among the findings of the HELP-AF (Home-based education and learning programme) study, which was presented by Prashanthan Sanders (University of Adelaide and Royal Adelaide Hospital, Adelaide, Australia) in a late-breaking science session at the European Society of Cardiology Congress (ESC 2019; 31 August–4 September, Paris, France). The educational material used in the study was simultaneously published in the Journal of the American College of Cardiology (JACC): Clinical Electrophysiology.
he initiative was designed to empower patients to understand and take control of their atrial fibrillation—that is, to improve self-management,” Sanders said during his presentation. “Its success in stopping hospital admissions has enormous implications for the delivery of care in atrial fibrillation. As healthcare costs grow due to hospitalisations, such programmes are essential.” Sanders and his colleagues believed that the involvement of patients in their own care, coupled with helping them to understand their AF and equipping them with the tools to manage it, might prevent hospitalisations. Writing in JACC: Clinical Electrophysiology, Celine Gallagher
(University of Adelaide, Adelaide, Australia) et al point out that rises in AF prevalence and hospitalisations necessitate effective strategies to mitigate these trends. HELP-AF recruited 627 individuals who presented to emergency departments at six hospitals in Adelaide, principally owing to AF, in a multicentre, randomised controlled trial. Patients were allocated randomly to HELP-AF intervention or usual care. They received follow-ups over a two-year period. “An educational resource was developed to support delivery of the intervention of the HELP-AF study,” write Gallagher and colleagues. “A literature review was performed exploring patient attitudes, knowledge and beliefs about AF. Additionally, a review of available patient
Society news resources for AF was undertaken. With the support of a multidisciplinary team and patient input, key messages were developed to achieve the behavioural goals of the intervention. Concise educational materials were then developed to support the delivery of the key messages. The educational materials were tested during various stages of the development process on AF patients to ensure they were readable, understandable and received feedback to facilitate modifications. The study version of the educational material was finalised only after approval from the multidisciplinary development team, clinicians, and individuals with AF.” Four key messages were developed. These covered the importance of taking AF medications as prescribed to reduce symptoms and stroke risk; the appropriate level of coagulation in managing stroke risk; the role that choosing a healthy lifestyle can play in lowering the risk of stroke and of AF becoming more severe; and the management of future AF episodes through a personal action plan, with the aim of conveying that such incidents are not usually medical emergencies. Patients randomised to the intervention group received two educational home visits by a nurse or pharmacist: one occurred two weeks after enrolment and the second took place six weeks later. A booklet was also supplied. The results showed that at the two-year point, total unplanned hospitalisations stood at 233 in the HELP-AF group and 323 with usual care, with an incident rate ratio of 0.74 (95% confidence interval (CI) 0.62–0.89, p=0.001), the authors told the session. After multivariable adjustment, the HELP-AF intervention reduced total unplanned hospitalisations by 26%, AFrelated hospitalisations by 31%, and other cardiovascular hospitalisations by 49%, while having no impact on non-cardiac
Study suggests increased use of DOACs in AF leads to lower healthcare costs
A four-year Italian study of oral anticoagulant (OAC) use in patients with atrial fibrillation (AF) has shown that, as prescription rates increased, healthcare costs per patient decreased. Prescription rates for antiplatelet agents fell during the same time period. Other trends observed in the study were that the rate of admissions for ischaemic stroke decreased, while those for intracerebral haemorrhages or major bleeds did not substantially change. ALDO PIETRO MAGGIONI (ANMCO Research Center, Florence, Italy) presented the findings on behalf of the investigators at ESC 2019. He explained: “Guidelines recommend strongly the use of OACs, while antiplatelet agents are not recommended. However, there is some real-world data showing relatively low prescription of OACs while antiplatelet [agents] are prescribed very frequently.” Researchers used the longitudinal Ricerca e Salute (ReS) database of more than 12 million individuals to assess the prescription rates for antithrombotic agents, and hospitalisation rates for AF, ischaemic stroke, and major haemmorrhage. The retrospective study was conducted between January 2012 and December 2015, and looked at patients who were discharged alive with a diagnosis of primary or secondary AF; 194,030 participants
were followed for one year after the index date (discharge) to assess medication use and further hospitalisations. Costs to the Italian National Health Service were assessed using drug prescription reimbursements, and national tariffs for outpatient Aldo Pietro Maggioni specialist services and hospitalisations. Investigators found that approximately four out of every 1,000 people in Italy are hospitalised yearly with AF, a figure that remained stable over the study period (3.98% in 2012 and 4.35% in 2015). Age and gender
hospitalisations. Sanders pointed to several components of the scheme as likely to have contributed to the fall in hospitalisations. These were that: education was delivered in the comfort of the patient’s home using language they could understand and focusing on areas important to them; patients received a booklet as an ongoing reminder of the four messages; the material listed questions patients could discuss with their physician to help manage their disease; and the booklet outlined the REST (rest, estimate pulse, see action plan and telephone) plan for patients to follow during AF episodes to avoid going to hospital. The latter included recommendations that patients seek personalised advice from a physician, and a dedicated telephone service for advice from a cardiologist. “The study shows that education delivered in a structured and individualised way within the patient’s home has a dramatic impact, not only on hospitalisations for atrial fibrillation, but on all cardiovascular hospitalisations,” Sanders said.
were also similar from 2012–2015, with a mean age of 77 years, and half of those studied were female. The main causes of readmission in the AF patients at one year were ischaemic stroke (21.3% in 2012 vs. 14.7% in 2015), acute coronary syndrome (13.9% in 2012 vs. 11.2% in 2015), and heart failure (9.6% in 2012 vs. 9.2% in 2015). The rate of haemorrhagic stroke fell from 6.5% to 4.1% during the study period, and major bleeds increased from 1.5% to 2.3%. The use of OACs increased during that time (from 56% in 2012 to 64% in 2015), and by 2015 the new direct OACs (DOACs), not yet prescribed in 2102, were prescribed to one-third of those with AF, and there was a marked decrease in prescriptions for antiplatelet drugs, in line with guidelines. Maggioni said: “There was a decrease in the rate of hospitalisation for ischaemic stroke; there was a slight decrease in the rate of hospitalisation for intracranial haemorrhage; there was an increase of hospitalisation for major haemorrhages. There was a clear decrease in the use of antiplatelet [agents]; there was a clear decrease in the use of vitamin K antagonists, and a very important increase in the use of DOACs. The major driver of the costs is hospitalisation, both for cardiovascular and non-cardiovascular reasons. In 2015, there was a clear decrease in the costs per patient, per year for patients admitted for atrial fibrillation.” However, Maggioni pointed out that the patient cohort was “sufficiently ill to require hospitalisation, and sufficiently strong to survive discharge”, and stressed that the study was descriptive. “This is just an association that cannot demonstrate causality,” he said.
Patients with implantable cardioverter defibrillators do not adhere to driving restrictions Jenny Bjerre Comment & Analysis Jenny Bjerre outlines the results of a study presented at the European Society of Cardiology Congress (ESC 2019; 31 August–4 September, Paris, France) which examined the information on driving restrictions provided to patients following implantable cardioverter defibrillator (ICD) therapy, and whether they are adhered to.
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Implantable cardioverter defibrillators
ue to the risk of arrhythmias and syncope, patients who have been fitted with an implantable cardioverter defibrillator (ICD) are restricted on when they are allowed to resume driving following implantation and appropriate ICD therapy. However, it is not known whether they are aware of these driving restrictions, and whether they adhere to them. According to the current recommendations of the European Society of Cardiology, patients with a primary prevention ICD can resume driving four weeks after ICD implantation; secondary prevention ICD patients and those who experience appropriate ICD therapy have to wait three months. All professional driving and driving of vehicles >3,500kg is permanently restricted.1 These limitations may lead to significant impacts on the daily lives of patients. For truck drivers and other professional drivers, in particular, the restrictions have an immediate bearing on their ability to maintain employment. Even for private drivers, getting to work and other daily activities, such as grocery shopping or visiting friends and family, are impeded. Therefore, it is not surprising that ICD patients do not adhere to these restrictions. But the magnitude of, and reason for, non-adherence remains unknown. We aimed to provide updated evidence on this topic, and designed a specific questionnaire to investigate the information given on the driving restrictions following ICD implantation and ICD shock; whether the ICD patients
adhere to the driving restrictions; and, lastly, which factors are associated with non-adherence.2 Through Danish nationwide registries, we were able to identify all living patients implanted with an ICD in the years 2013–2016, and link the patient-reported questionnaire results with register data on comorbidities, pharmacotherapy, and socioeconomic status. The questionnaire was distributed to 3,913 ICD patients in the spring of 2017, and achieved a response rate of 70%. Almost all (92%) held a valid driver’s licence at the time of ICD implantation, and 7% were actively using a professional driver’s licence during the six months prior to implantation. Only 42% of primary prevention patients, 63% of secondary prevention patients, and 72% of patients who experienced an appropriate ICD shock recalled being informed of any driving restrictions. Importantly, only 45% of professional drivers recalled being informed about specific professional driving restrictions. We also found that more than 30% of the patients resumed driving during the restricted periods: 34% of primary prevention patients resumed driving within one week (the recommended abstinence period in Denmark), 43% of secondary prevention patients within three months, and 30% of patients who had experienced an appropriate ICD shock were driving within three months after the shock. Professional driving had been resumed by 35%. The patients who returned to driving within the restricted periods were less likely to report having received
information about driving restrictions. In a multiple logistic regression model, non-adherence was likewise predicted by reporting non-receipt of information about driving restrictions (odds ratio [OR] 3.34), as well as male sex (OR 1.53), age 60 years (OR 1.2), receipt of a secondary prevention ICD (OR 2.2), and being the only driver in the household (OR 1.29). Income level, employment status, and preimplantation driving habits did not reach significance. Firstly, our study confirms that doctor– patient communication is difficult: up to almost 60% of patients reported they had not been informed about any restrictions for driving following ICD implantation. Even taking into account potential recall bias, these numbers are still too high. Naturally, patients do not remember everything they are told, and if you have recently survived a cardiac arrest, driving restrictions might not be your biggest concern. But, better communication is required—for example, by repeating the
not having received information was the largest predictor of non-adherence, and this gives us a lot of potential for improvement. Nevertheless, we also found that some ICD patients who recalled being informed chose to drive anyway. These patients’ behaviour is likely to be more difficult to change. From a previous qualitative study on the topic,3 the lack of consequences for driving while restricted was one important reason for non-adherence. Some ICD patients who cannot manage without their vehicle for their daily activities simply take the chance and drive. According to our results, physicians should be especially aware of male patients, secondary prevention patients, those >60 years, and patients who are the only driver in their household. Lastly, since driving restrictions have the potential to significantly impede the daily lives of ICD patients and limit their personal freedom, we believe we
Unsurprisingly, not having received information was the largest predictor of non-adherence, and this gives us a lot of potential for improvement.” information, explaining the rationale behind the restrictions, and including family members in the discussions. In Denmark, patients receive written information about life after an ICD implantation. The driving restrictions are discussed in these brochures. But, we need to acknowledge that there is no guarantee the patients read and understand the information provided. The findings for professional drivers are particularly worrisome. In Denmark, we need to be better at identifying patients with licences for vehicles >3,500kg or professional transportation, including those who might not be using the licence for their primary employment. Secondly, non-adherence to the driving restrictions was common. Unsurprisingly,
need more evidence on the absolute risk of traffic accidents in this patient population, and thus on the necessity of the driving restrictions. Jenny Bjerre is at the Copenhagen Cardiovascular Research Centre, Herlev and Gentofte Hospital, University of Copenhagen, Copenhagen, Denmark. References 1. Vijgen J, Botto G, Camm J, et al. Consensus statement of the European Heart Rhythm Association: updated recommendations for driving by patients with implantable cardioverter defibrillators. Europace 2009; 11: 1097–107. 2. Bjerre J, Rosenkranz SH, Christensen AM, et al. Driving following defibrillator implantation: development and pilot results from a nationwide questionnaire. BMC Cardiovascular Disorders 2018; 18: 212. 3. Bjerre J, Mørk SR, Mielke A, et al. Abstract 15698: Driving restrictions following defibrillator implantation: The patient’s perspective. Circulation 2017; 136: A15698–A.
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With his brothers Josep and Ramon, Pedro Brugada discovered the syndrome that bears their name. He reflects on his career highlights with Cardiac Rhythm News, charting the development of electrophysiology from esoteric to mainstream therapy, and stresses the role that maintaining curiosity plays in driving progress.
Why did you decide to become a doctor and why, in particular, did you decide to specialise in electrophysiology?
I became a doctor by chance. As the son of farmers, I would have loved to have taken over my parents work, but my mother was completely against it. So I chose the art academy, but my mother was against that too, as she was when I suggested a music conservatorium. Instead, she sent me to the University of Barcelona. As I did not know what I wanted to do, I registered for first-year medical school and first-year philosophy. I achieved 100% in all medical subjects in my first-year exams, so I decided to continue studying medicine. As a student, I had the opportunity to work all day (and night) at the hospital. I spent a lot of time in the haematology laboratory, and I wanted to become a haematologist. However, my mentor, Professor Rozman, discovered that I was too young to start and wanted me to wait for a year. My first daughter was due and I needed a job. There was a position free in cardiology— and that is how I became a cardiologist. I finished my cardiology training at the age of 26 years. My education at the University of Barcelona under the guidance of Professor Paco Navaroo was superb. But not much was known about cardiac arrhythmias, and Professor Hein Wellens had just moved to Maastricht’s new university. He accepted me as a fellow—believing that I had a grant that I had not, in fact, received—and I moved to Maastricht for a sixmonth fellowship. I never went back to Spain.
Who have been your career mentors?
At college, Professors Erundino Sanz and Josep Brugulat. At medical school, Professor Cirilo Rozman. During my cardiology training, Professor Paco Navarro, and Ginés Sanz and Amadeo Betriu. In electrophysiology, Professor Hein Wellens. But there have been other important people—Joan de Palau for arts, Josep Torrent for languages, Albert Stofberg for athletics and swimming, and my friends in my village, Banyoles, for music.
What has been the most important development in the field of electrophysiology during your career?
There have been many. It is difficult to choose. I have seen electrophysiology move from an esoteric field reserved for "crazy" minds to a subspecialty capable of curing practically any cardiac arrhythmia. Single chamber pacemakers evolved into DDD pacemakers, and into resynchronisation devices, and the implantable cardioverter defibrillator (ICD) became a reality during my early career as an electrophysiologist. Ablation and cardiac resynchronisation therapy (CRT) devices are probably the greatest contributions that electrophysiology has made to clinical medicine. Recently, the full entry of genetics into rhythmology has been another milestone.
What is the biggest challenge facing electrophysiology?
The biggest challenge is to correctly implement current knowledge. There are still many patients with cardiac arrhythmias who do not benefit from modern
technologies because there is no correct diagnosis, or because the treating physician is unaware of the possibilities. Electrophysiologists should come down to earth and educate general practitioners and general cardiologists about the therapies that are available for cardiac arrhythmias.
What has been your biggest disappointment? Something you hoped would change practice but did not?
I developed a technique for ablation of cardiac arrhythmias using intracoronary ethanol, which is still sometimes used, but it was completely overtaken by radiofrequency ablation. Although my technique did not become standard practice, it was a first step towards a cure for cardiac arrhythmia, so in that sense I am not disappointed. And I will never forget the editorial by Doug Zipes, entitled “Targeted therapyˮ, which accompanied my publication in Circulation on “Transcoronary chemical ablation of ventricular tachycardiaˮ.
Of the research you have been involved with, what do you think will have the greatest impact on clinical practice? Without any doubt, the publications on Brugada syndrome.
What are your current research interests?
Brugada syndrome remains my main research interest, but I am also still fascinated by classic electrophysiology mechanisms. Other recent interests include the application of artificial intelligence in rhythmology, and the circulatory system of the drosophila fly. And, in addition, all applications of hybrid surgery in the treatment of cardiac arrhythmias.
What do you consider to be the most important paper published on this topic during the past year? The most important paper on Brugada syndrome was the risk score by Dr Sieira that was published in the European Heart Journal; Papadakis’ paper, published in JACC, on family screening after sudden death of unknown cause was also valuable.
What are the key priorities for future research in this area?
We need serious randomised studies on the value of catheter ablation in Brugada syndrome. And in relation to hybrid therapy of cardiac arrhythmias, we need to train more cardiac surgeons to work with electrophysiologists.
How has the management of arrhythmias moved on from when you first described Brugada syndrome?
The developments have been very rapid and excellent. But we have also seen some disappointments. Quinidine seems of no value in Brugada syndrome. Ablation is promising, but we need randomised studies and these are almost impossible to perform. ICDs have proven to be effective and safe—when the risk–benefit ratios
There are still many patients with cardiac arrhythmias who do not benefit from modern technologies because there is no correct diagnosis, or because the treating physician is unaware of the possibilities.”
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Guidelines are rigid, and inconclusive in terms of decision-making, and they are also usually outdated at the time of publication. AI, through a continued self-learning process, will allow us to make the best decision for each patient at that time, because, as knowledge advances, AI will continuously update decision trees. AI-based protocols are open to everybody, and do not reflect the opinions of a few preselected experts as guidelines do, but the continuous interaction of potentially all the interested medical community.
What do you think the next breakthrough innovation in cardiac rhythm will be?
Clinical cardiac electrophysiology will inevitably continue its advance towards less invasive procedures. Current imaging and mapping techniques already allow superb high definition of areas of interest for ablation. Future improvements in non-invasive mapping techniques will allow specific characterisation of cardiac tissues at a near-microscopic level. In combination with laser technologies, it should allow precise non-invasive ablation of cardiac targets through the skin with no extracardiac damage. We will see the development of cathlabs where a single device will non-invasively localise the area of interest and simultaneously perform a transcutaneous ablation without damage to the skin.
What is the role of e-medicine in monitoring patients with chronic heart disease?
The role of e-medicine is underestimated. It is the best protection that one can offer to patients. They should be actively involved in their follow-up. Monitoring should be bidirectional—it should allow physicians to contact and changes device parameters through the internet. A 24/7 monitoring unit should be present in each centre involved with these types of patients.
Social media platforms such as Twitter and LinkedIn are increasingly used as a source of medical communication. What are the pros and cons of using social media for medical communication? I believe that their role will continue to increase in a positive way. However, this will only be feasible with full medical control. Amateur sites should be forbidden, and university hospitals should take full control of technology. Patient forums should be actively directed and corrected by medical institutions.
are carefully considered. We regularly performed pre-implant genetic diagnosis after in vitro fertilisation in couples where the genetic defect is known. This technology should spread rapidly in the future, to eliminate transmission of the disease.
What are the potential applications for artificial intelligence in rhythmology?
My main interst in the application of artificial intelligence (AI) in cardiac rhythmology is for it to primarily be used to get arrhythmia patients to the correct doctor as soon as possible. AI should be applied first to the basics of diagnosis. Once the correct diagnosis is made, a specific protocol can be setup, and the patient directed to the appropriate doctor for the most cost-effective, curative treatment. AI will make guidelines completely obsolete.
What has been your most memorable case?
My most memorable case was Lech, the first patient with the condition that later became known as Brugada syndrome. He is in my thoughts every morning when I wake, and every night when I go to bed. I regret his death every day.
Outside of medicine, what are your hobbies and interests? My hobbies are painting, music, and classic cars, and sports such as golf and sailing. My interests include history.
What would you have been if you had not been a medical doctor? It is impossible to know. Maybe instead of being a happy doctor, I would have been a happy farmer.
Scientific director, Cardiovascular Division, University Hospital UZ Brussel, Brussels, Belgium Chief executive officer, Medisch Centrum Prof P Brugada, Aalst, Belgium Director, Arrhythmia Unit Hospiten, Estepona, Spain
Selected education and prior appointments
1969–1975: Medical School, University of Barcelona School of Medicine, Barcelona, Spain 1979–1980: Research fellow in Clinical Cardiac Electrophysiology, University of Limburg, Maastricht, The Netherlands 1980–1984: Assistant professor, Department of Cardiology, University of Limburg 1982–1990: Director, Clinical Electrophysiology Laboratory, University of Limburg 1988–1990: Head, Division Coronary Disease, Institute for Cardiovascular Diseases, University of Limburg 2009–2011: Chair, Fellowship Committee, European Heart Rhythm Association 2011–2016: Chair, Cardiovascular Division Universitair Ziekenhuis Brussel, VUB, Brussels, Belgium 2016–2017: Scientific director, Arrhythmia Unit, GVM Italy, Cotignola, Italy 2017–2018: Director, BioMaster Education Programme
Selected professional honours and awards
1999: Fritz-Acker Stiftung Award, German Society of Cardiology 2001: Cardiologist of the Year 2001, Paris, France 2003: First price at the European Society of Cardiology, Vienna, Austria 2008: Mirowski Award, San Francisco, USA 2009: Einthoven Gold Medal, European Heart Rhythm Association 2009: Honorary member, Royal College of Physicians of Catalonia, Spain 2009: Elite reviewer award, European Heart Journal 2012: Gold Medal, European Society of Cardiology 2014: Expert, Highest Medical Council of the Federal Government of Belgium 2017: Honorary Lecture Frankfurt Academy For Arrhythmias (FAFA), Frankfurt, Germany 2019: Grand Prix Scientifique 2019, Institut de France, Fondation Lefoulon-Delalande, Paris, France
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Prediction model of individual arrhythmic risk in ARVC can be used for primary prevention Cynthia James Comment & Analysis Primary prevention of arrhythmic events in arrhythmogenic right ventricular cardiomyopathy remains challenging; Cynthia James explains how she and colleagues developed a model to select patients suitable for placement of implantable cardioverterdefibrillators, and what further refinements are needed.
rrhythmogenic right ventricular cardiomyopathy (ARVC) is an inherited cardiomyopathy characterised by frequent ventricular arrhythmias and a substantial risk of sudden cardiac death. Once ARVC is diagnosed, a primary management goal is prevention of sudden cardiac death, for which implantable cardioverterdefibrillators (ICDs) are a common consideration. There is general agreement that most ARVC patients diagnosed following an arrhythmic event benefit from a secondary prevention ICD. However, appropriate patient selection for primary prevention ICDs is challenging. Studies report annual event rates of 2–10% in primary prevention ARVC populations. These young, active patients also have a considerable risk of ICD complications and inappropriate interventions. A meta-analysis and systematic review conducted by our research team found most studies had insufficient statistical power to assess the independent predictive value of potentially correlated risk factors for arrhythmic risk in ARVC.1 To fill this gap, my colleagues and I aimed to develop a robust model for individualised prediction of incident sustained ventricular arrhythmias by including data from an international cohort of ARVC patients. Our findings
were initially published online in March 2019 in the European Heart Journal.2 The model can be accessed at www. arvcrisk.com. The success of this project reflects the work of all members of our large international team. We assembled a cohort of 528 patients with no history of sustained ventricular arrhythmia at diagnosis, per 2010 Task Force Criteria, from five international registries (Johns Hopkins, Dutch, Nordic, Swiss, and Canadian). The study population had equal representation from North America (n=259, 49.1%) and Europe (n=269, 50.9%). Our primary outcome was first sustained ventricular arrhythmia. Sustained ventricular arrhythmia was defined as a composite of sudden cardiac death, sudden cardiac arrest, spontaneous sustained ventricular tachycardia (VT) (lasting ≥30 seconds at ≥100 beats per minute, or with haemodynamic compromise requiring cardioversion), ventricular fibrillation/flutter, or appropriate ICD intervention. Potential predictors were prespecified, based on clinical experience and the ARVC risk stratification literature, including our systematic review and meta-analysis. These predictors were: sex, age, recent cardiac syncope (<six months), non-sustained VT, number of premature ventricular complexes on 24-
hour Holter monitoring, extent of T-wave inversion on anterior and inferior leads, and right and left ventricular ejection fractions. Each predictor variable was determined at diagnosis. We used standard statistical modelling methods. The association between the prespecified predictors and the primary outcome was assessed using Cox regression. The model was internally validated using 200 bootstrap samples. We also compared the performance of our model to that of the consensus-based algorithm for ICD placement published in the International Task Force Consensus Statement for Treatment of ARVC, including a decision curve analysis.3 During a median follow-up of slightly less than five years, 146 (27.7%) patients experienced incident sustained ventricular arrhythmias. Most events were appropriate ICD therapy (n=102, 70%) or spontaneous sustained VT (n=35, 23.9%). All prespecified predictors except left ventricular ejection fraction were included in the final model, with younger age, male sex, recent syncope, history of non-sustained VT, greater extent of T-wave inversions, higher premature ventricular contractions (PVC) count, and lower right ventricular ejection fraction associated with arrhythmias. The model accurately distinguished
Our model was superior to the published consensus-based implantable cardioverter-defibrillator placement algorithm.” patients with and without events, with an optimism corrected C-index of 0.77 (95% confidence interval [CI] 0.73–0.81) and minimal over-optimism (calibration slope of 0.93, 95% CI 0.92–0.95). By decision curve analysis, our model was superior to the published consensus-based ICD placement algorithm. Our model performed better at any risk threshold, and would achieve a 20.6% reduction of ICD placements with the same proportion of protected patients. Using the largest cohort of ARVC patients with no history of sustained ventricular arrhythmias at diagnosis, we developed a prediction model that generates individualised estimates of
LAA closure is non-inferior to NOACs
At the European Society of Cardiology Congress (ESC 2019; 31 August–4 September, Paris, France), Pavel Osmancik (Charles University and University Hospital Kralovske Vinohrady, Prague, Czech Republic) presented the results of PRAGUE-17. These showed that left atrial appendage closure (LAAC) was non-inferior to non vitamin-K-antagonists (NOACs) for the prevention of major cardiovascular and neurological events in patients with non-valvular atrial fibrillation (AF). However, Osmanik observed that “safety issues” with LAAC remain. HE COMMENTED THAT both LAAC and NOACs have advantages over vitamin K antagonists—warfarin, the traditional first-line therapy—for reducing thromboembolic events in patients with AF. Studies have indicated that LAAC is associated with reduced rates of intracranial haemorrhage (and a similar reduction in stroke), and that NOACs are associated with less intracranial haemorrhage, all stroke and mortality. He
the risk of incident arrhythmias using readily available clinical parameters. Importantly, our study does not aim to prescribe ICD placement for a given patient. Instead, we sought to provide clinicians and patients with information to facilitate shared clinical decisionmaking. There are opportunities to further refine our model. Participation in high intensity aerobic exercise is an established riskfactor for ventricular arrhythmias in ARVC. Whether exercise history or plans can be used to further refine risk prediction is unresolved. Other predictors may also merit consideration, including programmed ventricular stimulation results and genotype. There are also several caveats to the model that should be kept in mind. Firstly, ARVC is a progressive disease so patients should be periodically restratified. Secondly, ascertainment of our study population from tertiary care settings may mean the model over-estimates arrhythmia risk in a community-derived population. This highlights the importance of external validation as a next step. And, finally, by including ICD-treated arrhythmias in our outcome, the model almost certainly over-estimates risk of sudden cardiac death. This should be kept in mind when considering the risk estimates generated.
added: “The relative safety and efficacy of LAAC versus NOAC is unknown.” In PRAGUE-17, 201 patients with non-valvular AF were randomised to LAAC with either the Amplatzer Amulet device (Abbott) or the Watchman/Watchman Flex device (Boston Scientific); another 201 were randomised to receive a NOAC. The primary endpoint was a component of stroke or transient ischaemic
Cynthia James is assistant professor of medicine (cardiology) and a genetic counsellor in the Arrhythmogenic Right Ventricular Dysplasia/Cardiomyopathy Program at the Johns Hopkins University School of Medicine in Baltimore, USA. References 1. Bosman LP, Sammani A, James CA, et al. Predicting arrhythmic risk in arrhythmogenic right ventricular cardiomyopathy: A systematic review and metaanalysis. Heart Rhythm 2018; 15(7): 1097–107. 2. Cadrin-Tourigny J, Bosman LP, Nozza A, et al. A new prediction model for ventricular arrhythmias in arrhythmogenic right ventricular cardiomyopathy. Eur Heart J 2019; 40(23): 1850–8. 3. Corrado D, Wichter T, Link MS, et al. Treatment of arrhythmogenic right ventricular cardiomyopathy/ dysplasia: an international task force consensus statement. Eur Heart J 2015; 36(46): 3227–37.
attack, systemic embolism, clinically significant bleeding, or significant periprocedural or device-related complications. Follow-up was at six weeks, three months, nine months, and 12 months (and then every six months). There were no significant differences between groups in the cumulative incidence function for the primary endpoint (p=0.004 for non-inferiority of LAAC versus NOACs). This was the case for both the per-protocol populations and intention-to-treat populations. Osmancik concluded: “In the current NOAC era, LAAC may be considered with an adequate rationale for a non-pharmacological alternative; similar overall outcomes are expected with each of these strategies.” He added: “The incidence of the primary outcome was very similar during the whole study period, which make the results very convincing.”
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Liverpool Centre for Cardiovascular Science established to reduce cardiovascular burden Gregory YH Lip Comment & Analysis The Liverpool Centre for Cardiovascular Science, an alliance between academia and the NHS, was established to advance cardiovascular and stroke research and innovation locally, nationally, and internationally. The director of the centre, Gregory YH Lip explains the concept.
iverpool is a disadvantaged city, with high levels of cardiovascular disease (CVD) that are a leading cause of death and disability and associated health inequalities. The mission statement of the recently established Liverpool Centre for Cardiovascular Science is to support the citizens of the Liverpool City region to live healthier lives, free of cardiovascular diseases and stroke. The vision is that,
by 2024, implementation of this strategy will have contributed directly to improved cardiovascular health and reduced premature death from cardiovascular diseases and stroke. Officially launched in September 2018 at Liverpool Town Hall on the eve of World Heart Day (https://bit. ly/2CWDtPg), the centre brings together experts from academic institutions and NHS partners at the University of
DAPA trial shows prolonged survival with early ICD use after percutaneous coronary intervention The long-term outcomes of the Defibrillator after primary angioplasty (DAPA) trial indicate that early use of an implantable cardioverter defibrillator (ICD) after percutaneous coronary intervention (PCI) lengthens survival in patients at high risk of death after ST-segment elevation myocardial infarction (STEMI). The study found that the benefits of ICD use are preserved during follow-up of nine years, even though 46% of the patients in the trial, both those treated with optimal medical therapy and those implanted with an ICD, showed left ventricular ejection fraction (LVEF) improvement. LEAD AUTHOR DANIELLE Haanschoten (Isala Hospital, Zwolle, The Netherlands) presented the late breaking results from the DAPA trial in a Hotline Session at the European Society of Cardiology Congress (ESC 2019; 31 August–4 September, Paris, France). Haanschoten explained: “It has been unclear which patients might gain from a prophylactic ICD to reduce sudden cardiac death early after primary PCI.” This uncertainty has arisen as the MADIT II trial included
Liverpool, Liverpool Heart and Chest Hospital, Liverpool John Moores University, and Liverpool Health Partners, to work for the advancement of cardiovascular and stroke research. This exciting collaboration has assembled a multidisciplinary group of NHS and academic (clinical and non-clinical) researchers in a cross-university, crossdepartmental partnership to develop research without boundaries. The Liverpool Heart and Chest Hospital hosts the clinical base of the Liverpool Centre for Cardiovascular Science, providing the academic department with the opportunity for high quality cardiovascular research in newly refurbished facilities. Atrial fibrillation will be one of the primary research areas of the centre, given the major interest and research into this disease area. Other fields of interest include hypertension, thrombosis and antithrombotic therapy, imaging, and clinical epidemiology. The centre will become part of a global
network of cardiovascular research, working particularly closely with Aalborg University in Denmark (with which I am also affiliated in my role as a distinguished professor), and numerous other formal academic partners in Serbia, China, Japan, Taiwan, Korea, Thailand, Sri Lanka, and Brazil. Given the broad spectrum of research interests, the Liverpool Centre for Cardiovascular Science aspires to make a major impact in cardiovascular research and innovation, in order to improve our understanding of the disease and the clinical care of patients, with the goal of reducing the healthcare burden at a local, national, and international level. www.liverpool.ac.uk/lccs https://twitter.com/LiverpoolCCS Gregory YH Lip is Price-Evans chair of cardiovascular medicine at the University of Liverpool and CVD programme director for Liverpool Health partners, Liverpool, UK.
The vision is that, by 2024, implementation of the strategy will have contributed directly to improved cardiovascular health and reduced premature death from cardiovascular diseases and stroke.”
45% PCI patients and the mean time from myocardial was performed in February 2019, and secondary infarction until ICD implantation was 6.7 years. Early endpoints were cardiac death and non-cardiac death. ICD implantation (<40 days) after myocardial infarction At the time that the trial was prematurely terminated, may be harmful , as was shown in two primary a total of 266 patients had been included, with the prevention trials (DINAMIT and IRIS). majority (76%) of patients based on LVEF <30%, and She said: “The results of the DAPA trial indicate that one-third based on TIMI flow <3. ICD was implanted certain high-risk patients may benefit from early ICD with a median of 50 days (interquartile range [IQR] implantation after PCI. However, the study was stopped 41–60 days) after STEMI. prematurely. Therefore, more research is needed to Haanschoten said: “The all-cause mortality curves support these findings.” started to diverge before the first year, In the first six months after STEMI, and there was already a significant ICD the risk of death, particularly sudden benefit after three years follow-up (hazard cardiac death, is high. Currently, ESC ratio [HR] 0.36, 95% confidence interval guidelines recommend that prophylactic [CI] 0.14–0.93, p=0.04). ICD implantation be performed at least After long-term follow-up of nine six weeks after myocardial infarction years, all-cause mortality occurred in in ischaemic aetiology, while American 24.4% of the ICD group versus 35.5% guidelines recommend prophylactic in the control group, with a HR of 0.58 ICD implantation at least 40 days after (95% CI 0.37–0.91). The rate of cardiac myocardial infarction, and at least 90 death was 11.4% in the ICD group and days after revascularisation. 18.5% in the control group (HR 0.52, The aim of the DAPA multicentre, 95% CI 0.28–0.99). randomised controlled trial, therefore, Non-cardiac death was not significantly was to examine whether ICD Danielle Haanschoten different between the two groups. Rates implantation between 30 and 60 days of sudden cardiac death were higher in after primary angioplasty for STEMI would provide the control group versus the ICD group at three years a survival benefit in patients at high risk of death. follow-up (3.7% vs. 0.8%), and also after long-term High risk was defined as at least one of the following: follow-up of nine years (3.1% vs. 5.9%), but these primary ventricular fibrillation (<24 hours), LVEF results were not significantly different. below 30% within four days from hospital admission, Follow-up after 18 months showed LVEF Killip class 2 or higher, or thrombolysis in myocardial improvement of at least 10% in 46% of the patients infarction (TIMI) flow <3 after primary PCI. in both study groups. Despite this improvement, ICD Patients from 12 hospitals in The Netherlands and benefit was preserved during long-term follow-up. Poland were randomly allocated either to prophylactic Haanschoten concluded: “Together with the results of ICD implantation or to optimal medical therapy. The previous trials, the DAPA trial may contribute to early primary endpoint of the study was all-cause mortality selection of high-risk patients who will profit from an after at least three years of follow-up for each patient. ICD after primary PCI for STEMI. The unexpected The trial was halted prematurely in 2013 on the ending of the study is an important limitation, and advice of the data safety monitoring board, due to a further studies in the current primary PCI era are needed slow inclusion rate. An additional survival assessment to confirm these findings.”
October 2019 | Issue 46
Sudden cardiac death
Making a case for cardiovascular genetic testing in patients who survive an unexplained cardiac arrest Babken Asatryan Comment & Analysis Sudden cardiac arrest remains a major cause of death among young people. Babken Asatryan outlines his research into the genetic basis of the disease, and discusses the clinical usefulness that his findings on genetic mutations could have for the diagnosis of unexplained cardiac arrest.
ince the early days of genomic medicine, medical researchers have invested tremendous effort in dissecting the genetic architecture of sudden cardiac arrest and sudden death. Many familial traits and conditions have been revealed, but sudden cardiac arrest continues to be an enormous public health problem worldwide, particularly because it is a major cause of death in apparently healthy young subjects. Nowadays, genetic testing of patients with potentially heritable arrhythmic heart disease helps in decision-making, and allows identification of genetically
affected presymptomatic family members who might benefit from early diagnosis and therapy. A small proportion of cardiac arrest survivors have no history or signs of heart disease and first come to medical attention at the time of a cardiac arrest. Could genetically-mediated heart disease cause life-threatening arrhythmias at the stage when they are still “confined to the genome”—that is, before the manifestation of diagnostic signs of the disease? To answer this question, my colleagues and I studied a cohort of 60 sudden cardiac arrest survivors, consisting of
24 patients with a clinical suspicion or diagnosis of cardiomyopathy or inherited arrhythmia, and 36 patients with uncertain cause of cardiac arrest after thorough evaluation. Our findings were published online in March 2019 in the American Journal of Cardiology.1 We performed comprehensive clinical examination of all enrolled survivors of cardiac arrest, following international guidelines. Patients with signs of a genetic arrhythmia or cardiomyopathy, and those whose clinical examination failed to reveal a cause, were then screened for disease-causing mutations in 185 genes with known association to heritable cardiovascular diseases. We detected 32 disease-associated mutations in 27 patients—45% of the entire cohort. Mutation carriers included 17 out of 24 (71%) patients with a cardiomyopathy or primary arrhythmia syndrome, and 10 out of 36 (28%) survivors with no signs of heart disease. Among those with cardiomyopathy or arrhythmia, the detected mutations confirmed the clinical diagnosis; in subjects with no signs of heart disease, the mutations revealed clinically silent disease in a significant proportion of cases. It is noteworthy that the mutations detected in patients with no signs of heart disease were localised not only to cardiac ion channel genes, but also to genes encoding myocardial structural proteins involved in cardiomyopathies. Cardiac arrest in mutation carriers with otherwise normal heart function is likely to represent the first manifestation of a “concealed” inherited arrhythmia or a cardiomyopathy, and we have called for further investigations to assess this concept in follow-up studies. The guidelines for evaluation of patients with primary arrhythmia syndromes, written in 2013,
Registry study supports use of ICDs for primary prevention in patients with heart failure New data from the Swedish Heart Failure Registry indicate the use of an implantable cardioverter defibrillator (ICD) in patients with heart failure with reduced ejection fraction (HFrEF) is associated with a significant reduction in all-cause mortality at both one year and five years. This finding is in keeping with current European Society of Cardiology (ESC) guidelines for heart failure, which advocate using ICDs for the primary prevention of sudden cardiac death in patients with HFrEF. SPEAKING AT THE ESC Congress (ESC 2019; 31 August–4 September, Paris, France), study investigator Benedikt Schrage (Department of General and Interventional Cardiology, University Heart Center Hamburg, Hamburg, Germany) said the current ESC recommendations of ICD use “were based on trials that were initiated ≥20 years ago and might not represent characteristics and treatments of a contemporary HFrEF cohort”. He added that a decline in the incidence of sudden cardiac death alongside improved outcomes in patients with HFrEF “have raised further questions regarding the benefits of primary prevention with ICD”. Therefore, the aim of the present study, simultaneously published in Circulation, was to review the association between the use of ICD for primary prevention and all-cause mortality in a contemporary
and large HFrEF cohort. Using data from the Swedish Heart Failure Registry, Schrage et al identified 16,702 patients who (according to ESC guidelines) were eligible for primary prevention with an ICD. Of these, 10% had actually been treated with an ICD. The investigators then used propensity matched scoring to compare outcomes of 1,305 ICD patients with 1,305 non-ICD patients. Primary outcomes were the one-year and five-year rates of all-cause mortality. Secondary outcomes included the one- and five-year rates of cardiovascular death. At one year, significantly fewer ICD patients had died than non-ICD patients, with absolute risk reduction of 4.2%. All-cause mortality was also reduced in the ICD group at five-years, but the absolute risk reduction was lower (2.1%). Gerhard Hindricks (Department
recommended against genetic testing in survivors of clinically unexplained cardiac arrest. But over the past five years, experimental evidence has been accumulating that suggests that some gene mutations may have pro-arrhythmic potential at an early disease phase. Our data establish the clinical usefulness of genetic testing in cardiac arrest survivors, and further expand the knowledge on genetics of clinically unexplained cardiac arrest. The main message of our study is that diagnostic cardiovascular genetic testing should be considered not only in survivors with a robust phenotype, but also in unexplained cardiac arrest survivors, to allow for better identification of the arrhythmic substrate. However, investigators need to be careful when interpreting genetic data to avoid variant misclassification and subsequent unnecessary interventions. And, what about the cases that remain unexplained after cardiac genetic testing? A number of factors can be involved in the pathogenesis of cardiac arrest. Potential explanations might include currently unknown monogenic causes, or a complex genetic susceptibility composed of the cumulative effect of genetic modifiers, intoxications with unknown cardiotoxic substances, autonomic imbalance, and perhaps other factors that we are currently not aware of. Further research needs to focus primarily on these aspects. Babken Asatryan is a postdoctoral researcher in arrhythmias and cardiogenetics at the Department of Cardiology in Bern University Hospital, Bern, Switzerland. References: 1. Asatryan B, Schaller A, Seiler J, et al. Usefulness of genetic testing in sudden cardiac arrest survivors with or without previous clinical evidence of heart disease. Am J Cardiol 2019; doi:10.1016/j.amjcard.2019.02.061.
of Electrophysiology, Heart Center Leipzig at University of Leipzig, Leipzig, Germany), in a discussion following the presentation of the study, said the finding that the benefit on all-cause mortality appeared to decrease after a year was “difficult to explain”. He Benedikt Schrage noted: “Other ICD studies have shown that if there is an effect [with ICD primary prevention], it is consistent over time.” ICD use was also associated with a significant reduction in cardiovascular mortality at one year, but not at five years. And the results were consistent in all evaluated subgroups, including women and patients with ejection fraction ≤30%. However, Schrage said there were some limitations to the study, the most important of which was that it was observational and, therefore, showed an “association between exposure and outcome; it did not show causality”. He told Cardiac Rhythm News: “In the past, concerns regarding the benefit in patients treated with guidelinerecommended heart failure medications and high perception of contraindications could have reduced use of ICDs. The results of our study might thus encourage better implementation in clinical practice.”
October 2019 | issue 46
AtriCure agrees to buy LARIAT developer SentreHEART AtriCure has entered into a definitive agreement to acquire SentreHEART, which developed the LARIAT device for left atrial appendage closure in patients with atrial fibrillation. A press release reports that the transaction consideration consists of an upfront payment of approximately US$40 million in cash and AtriCure common stock, plus additional contingent consideration based on the achievement of certain clinical and reimbursement milestones.
competitive position in the market.” AtriCure already has a portfolio of electrophysiology products, including the Isolator Synergy ablation system—the only US Food and Drug Administration (FDA) approved device for the management of persistent atrial fibrillation. It also has the AtriClip left atrial appendage Exclusion System range of products, which the press release reports “are the most widely sold left atrial appendage devices worldwide”. AtriCure projects total revenue for 2019 to be in the range of $224.5 million to $228.5 million, which includes minimal contribution from SentreHEART, and reflects approximately 11% to 13% organic growth. Furthermore, revenue contribution from the SentreHEART business is expected to be nominal until after completion of the aMAZE trial and PMA approval. Andy Wade, senior vice president and chief financial officer, comments: “We have a strong balance sheet, which has been reinforced by our credit facility with Silicon Valley Bank. As a result, we believe that we can
support both the upfront payment and ongoing investments in the combined business with minimal shareholder dilution. While this transaction will impact short and medium-term profitability, we do not need to raise additional capital to finish the aMAZE Trial or support post-trial commercialisation efforts.”
Use of left atrial appendage closure devices in top five EU markets
Data from the BIBA MedTech LAA monitor indicates that during Q2 (1 April–30 June) of this year, 3,743 left atrial appendage devices were implanted in the top five EU markets (France, Germany, Italy, Spain, and the UK). Nearly half of these (47.9%) were with Abbott’s Amplatzer Amulet device and another 42.8% were with Boston Scientific’s Watchman/ Watchman Flex. Only 4.8% of implants were with the LARIAT system. The monitor does not provide any details on how many Atricure devices were implanted, but they may have been included as part of “others” (1.7%) (See Figure 1).
Source: BIBA MedTech Insights
OF THE CONTINGENT consideration, the press release adds, $140 million is based on milestones related to the aMAZE IDE clinical trial—including premarket approval (PMA)—and $120 million is based on a milestone related to reimbursement for the therapy involving SentreHEART devices. All contingent consideration would be payable in a combination of cash and stock. The aMAZE trial (ClinicalTrials. gov Identifier: NCT02513797) is an ongoing, randomised controlled trial that is evaluating the safety and effectiveness of the LARIAT system to percutaneously isolate and ligate the left atrial appendage from the left atrium as an adjunct to planned pulmonary vein isolation catheter ablation (vs. catheter ablation alone) for the management of patients with persistent or long-standing atrial fibrillation. It is expected to enrol up to 600 patients at 65 sites with one-year follow-up, and the primary endpoint measures are freedom from episodes of atrial fibrillation greater than 30 seconds at one-year post treatment. According to the SentreHEART
website, the non-invasive LARIAT procedure “closes the left atrial appendage by remotely delivering a pre-tied suture loop precisely to the base of the left atrial appendage for immediate and complete closure”. The website notes that “unlike other devices”, the LARIAT device does not leave anything behind in the inside of the heart, stating “within a few months after closure with the LARIAT, the left atrial appendage will disappear and never again be a source of blood clots”. Michael Carrel, president and CEO of AtriCure, comments: “We believe that SentreHEART is a strategic addition to AtriCure, significantly expanding our addressable markets with a product designed for electrophysiologists. With our pursuit of labelling based on the aMAZE Trial, we are deepening our commitment to provide the broadest possible offering of ablation and left atrial appendage management solutions to our customers and their patients.” He adds: “We believe, that upon FDA approval, use of the LARIAT device will continue to advance AtriCure’s
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Issue 46 | October 2019
Devices and companies
Product News FDA grants Breakthrough Device Designation for the WiSE CRT
EBR Systems has announced that the US Food and Drug Administration (FDA) has granted Breakthrough Device Designation for its WiSE cardiac resynchronisation therapy (CRT) for the treatment of heart failure. The WiSE (wireless stimulation endocardially) CRT system is designed to improve the heart’s pumping ability by synchronising the left and right ventricles to distribute blood to the lungs and body more effectively. To regulate precise pacing from within the heart, a press release reports, WiSE uses a unique, wireless electrode the size of a rice grain, implanted in the left ventricle wall in a minimally invasive procedure. This provides a greater choice of pacing locations, enabling patient-specific customisation of pacing site and may improve CRT response. The system is being evaluated in the IDE-approved SOLVE CRT clinical trial. This prospective randomised, double blinded pivotal trial is intended to assess safety and efficacy of the pacing technology in support of FDA approval. The study is enrolling 350 heart failure patients in the USA,
Europe, and Australia who have failed to respond to, or are unable to receive, conventional CRT. John McCutcheon, president and CEO of EBR systems, comments: “This Breakthrough Device Designation underscores the need for novel solutions for heart failure patients, who have few options today. We are excited that the WiSE System has received Breakthrough Status, which will enhance the review process to bring this important technology to these patients.”
First patient enrolled in European study of AccuCinch ventricular repair system
The first patient has been enrolled in the CorCinch EU study, which is a European multicentre clinical evaluation of the AccuCinch ventricular repair system (Ancora Heart) as a treatment for patients with reduced ejection fraction systolic heart failure. This is the second recently initiated study evaluating the AccuCinch system that specifically focuses on heart failure and the enlarged left ventricle. It will enrol up to 132 patients from heart centres across Europe. The transcatheter AccuCinch therapy
Industry News iRhythm and Verily to collaborate on health management solutions for atrial fibrillation patients
iRhythm Technologies has announced a collaboration with Verily to develop solutions aimed at improving the screening, diagnosis, and management of patients with atrial fibrillation (AF). A press release from iRhythm says the move brings together its expertise in artificial intelligence (AI)-based arrhythmia diagnosis and Verily’s advanced health data analytics technologies to address the needs of the millions of patients living with undiagnosed AF. iRhythm and Verily will work together on solutions capable of providing earlier warnings, enabling the identification and management of patients who might otherwise be undiagnosed until they have a cardiac event, such as a stroke. The company points out that clinical research is demonstrating a major unmet need for an early warning approach. At the American College of Cardiology annual meeting in May, the first phase of the mSToPS study, published in JAMA, showed that patients diagnosed with AF in iRhythm's Zio service-monitored group had a significantly lower rate of hospitalisations and emergency room
admissions than the non-monitored control group. iRhythm will make an upfront payment to Verily of US$5 million, and potential milestone payments of up to US$12.75 million upon the achievement of development and regulatory milestones.
RHYTHM AI successfully closes seed financing round
RHYTHM AI has announced the closure of a £2.15 million seed financing round. The round was led by an affiliate of Rinkelberg Capital, a private wealth management firm based in London, and supported by investment from founders. The proceeds will fund a multicentre study of STAR Mapping to improve outcomes of persistent AF treatment. STAR Mapping is a new, artificial intelligence (AI)-driven mapping system developed by cardiologists at St Bartholomew’s Hospital, London, UK, using novel computer algorithms to identify the sources or drivers of AF. The platform uses data acquired from standard equipment typically used in the procedure to treat the condition. In a press release, the company points out that outcomes in a single-centre study, published in May 2019, demonstrated that 80% of patients treated in a single
is designed to complement and enhance the existing care that cardiologists provide to further manage symptoms and slow, or stop, the progression of heart failure. For some patients, AccuCinch may have the potential to reverse the enlargement of the left ventricle; and
Biotronik's DX system
for patients for whom the heart failure has progressed beyond the ability for medications and pacemakers to manage symptoms, it may provide an effective treatment option. The system is designed to directly repair the left ventricle of the heart, thereby addressing the fundamental issue in the progression of systolic heart failure. The first patient was enrolled in the study at Homolka Hospital in Prague by Petr Neužil (Homolka Hospital, Prague, Czech Republic), who is the principal investigator. procedure using STAR Mapping were free of AF without the use of antiarrhythmia drugs at an average of 18.5 months follow-up. It says this compares favourably to a study published in 2015, which demonstrated 48% of patients free form AF at 18 months follow-up using the standard mapping treatment. Simon Hubbert, executive chairman of RHYTHM AI, said: “We are delighted to have successfully closed this seed financing round, and we welcome our new investors. We look forward to deploying the proceeds from the financing to further demonstrate the potential of our proprietary STAR Mapping platform to improve outcomes in a multicentre clinical study of patients being treated for persistent AF.”
Omar Ishrak to step down as Medtronic CEO next year Omar Ishrak, Medtronic’s chairman and CEO is to retire on 26 April 2020, following the end of the company’s current fiscal year. The Medtronic board of directors has announced key leadership appointments as part of its multiyear, leadership succession planning process. A press release reports that these announcements will ensure a smooth and successful transition in leadership across the company. The board of directors has unanimously appointed Geoff Martha, currently executive vice president (EVP) of the company’s Restorative Therapies Group (RTG), to assume the newly created role of Medtronic
SENSE data show DX system equivalent to dual-chamber ICDs and superior to singlechamber in AHRE detection
Biotronik has announced the publication of the SENSE trial results in the Journal of Cardiovascular Electrophysiology, showing that its DX system is equivalent to dual-chamber implantable cardioverter defibrillators (ICDs) in detecting atrial high-rate episodes (AHREs), and superior to singlechamber ICDs. Primary investigator George Thomas (Weill Cornell Medical College, New York, USA) said: “We have proven that the DX system gathers significant data with a single lead. Having the benefits of dual-chamber diagnostics without the need for an atrial lead is a true advantage for electrophysiologists. The system can be trusted to deliver appropriate therapy while providing exceptional diagnostic data that improves patient care and outcomes.” AHREs create an increased risk of developing atrial fibrillation (AF). Typically, atrial sensing capabilities require an additional lead, increasing the risk of complications. Biotronik’s DX system, featured in both ICD and cardiac resynchronisation therapy defibrillator (CRT-D) devices, detects a true atrial signal without the need for an atrial sensing lead—reducing costs, complexity and implant time compared to dual-chamber ICDs, says the company in a press release.
president and become a member of the Medtronic board of directors, effective 1 November 2019. He will also succeed Ishrak as Medtronic CEO, effective 27 April 2020. As president, according to the press release, Martha will lead Medtronic’s operating groups and regions. Brett Wall, president of Medtronic’s Brain Therapies division, was appointed EVP and group president of RTG, succeeding Martha, effective 1 November 2019. Ishrak will assume a new position of executive chairman at the start of Medtronic’s next fiscal year, He will provide counsel and guidance to Medtronic’s leadership, oversee CEO succession, and drive the ongoing successful execution of Medtronic’s long-term strategic plan. These changes are designed to ensure a smooth transition, continuity of leadership and a continued focus on delivering Medtronic’s innovation strategy and financial performance.