Cardiac Rhythm News Issue 42 – October 2018 EU edition

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Novel anticoagulants associated with lower all-cause mortality compared to VKAs A new analysis of the Global Anticoagulant Registry in the FIELD-Atrial Fibrillation (GARFIELD-AF Registry) shows that non-vitamin K antagonist oral anticoagulants (NOACs) are superior to vitamin-K antagonists (VKAs) in reducing two-year mortality in higher risk patients, which the study defined as those with a CHA2DS2-VASc score ≥2. In a cohort of 19,134 patients, there were 19% fewer deaths in patients who received NOACs compared to VKAs at the time of atrial fibrillation diagnosis (adjusted HR: 0.81; 95% CI 0.71, 0.92; p<0.001).

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he data were presented at the European Society of Cardiology Congress (ESC; 25–29 August, Munich, Germany) by John Camm, (St George’s, University of London, London, UK).

Commenting on the results, he said, “These real-world data may reflect the impact of poor VKA control, which was found to be associated with a high risk of events according to previous research.”

The results also showed that there were 17% fewer deaths (adjusted HR: 0.83; 95% CI: 0.75, 0.93; p<0.001) and 27% fewer strokes/systemic emboli (adjusted HR: 0.73; 95% CI: 0.59, 0.90; p=0.003) with anticoagulants compared with no anticoagulant therapy in higher risk patients with a CHA2DS2-VASc score ≥2. Camm said, “This new evidence of 26,742 GARFIELD-AF patients analysed over two years suggests that anticoagulant therapy has a beneficial effect beyond stroke prevention.”

The GARFIELD-AF registry began enrolment in 2010 and ended in 2016, recruiting over 60,000 patients. Using data from the GARFIELD-AF registry, the aim of this study was to compare the baseline characteristics and comparative safety and effectiveness of treatment with or without anticoagulants, as well as NOACs and VKAs in patients with newly diagnosed atrial fibrillation (AF).

Patients from 35 countries who had been newly diagnosed with AF, with at least one factor for stroke, were enrolled between April 2013 (after NOAC therapy had become established in many countries)

and September 2016. Patients with a CHA2DS2-VASc score ≥2 were included, while and only those with incomplete information or who had previously been treated with VKAs were excluded. This left a cohort of 26,742 patients eligible for analysis.

Of these patients, 19,134 (71.6%) received oral anticoagulants, with 10,234 (53.5%) being treated with NOACs and 8,900 (28.4%) being treated with VKAs. No anticoagulant was given to 7,608 (28.4%) of patients. Sixty per cent of patients who did not receive anticoagulation therapy received antiplatelet therapy.

Those receiving oral anticoagulants were more likely to be Caucasian (67.6%), while a higher proportion of Asian people received no anticoagulation (38.4%).

There was a 17% relative risk reduction for all-cause mortality over two years for those who received oral anticoagulants compared to no anticoagulant (HR: 0.83; 95% CI: 0.75, 0.93). The risk of stroke/systemic embolism was also significantly increased in patients who were not receiving anticoagulation therapy (HR: 0.73; 95% CI: 0.59–0.90; p=0.003), however those receiving oral anticoagulants were more likely to suffer a major bleed (HR: 1.36; 95% CI: 1.00, 1.85; p=0.003).

Overall, there was a significant risk reduction of all-cause mortality for patients receiving NOACs compared to VKAs, with a relative risk reduction of 19%. There was also a higher rate of stroke/systemic embolism and major bleeding in those receiving VKA therapy but this was not significant.

Continued on page 2

New guidelines:

CV management during pregnancy

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Tim Betts:

Profile

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CABANA trial provides important new data on clinical and quality of life effects of ablation for atrial fibrillation Catheter ablation for atrial fibrillation (AF) produced no significant improvement in death, disabling stroke, serious bleeding, or cardiac arrest but did reduce death or cardiovascular hospitalization and recurrent AF in the Catheter Ablation versus Antiarrhythmic Drug Therapy (CABANA) trial, the largest randomised controlled trial of AF ablation in the morethan-two-decade long history of the procedure. The primary clinical results were presented at the Heart Rhythm Society’s Scientific Sessions (HRS; 9–12 May, Boston, USA) by principal investigator Douglas L Packer (Mayo Clinic, Rochester, USA).

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he goal of the trial was to compare the safety and efficacy of catheter ablation compared with drug therapy for the treatment of patients with new-onset or untreated symptomatic AF. CABANA randomised 2,204 patients with newonset or undertreated AF to catheter ablation (with a primary approach of pulmonary vein isolation) or drug therapy that included either rate or rhythm control (87.2% received rhythm control). Anticoagulation was used in both groups.

In the trial patients were randomised in a 1:1 fashion to either catheter ablation (n=1,108) or drug therapy (n=1,096) and were followed for a median of 48.5 months. The mean patient age was 67.5 years and 37% of those enrolled were female.

A significant proportion of the cohort suffered from co-morbidities: 9% had cardiomyopathy; 15% had chronic heart failure; 10% had prior cerebrovascular accidents or transient ischaemic attacks; 43% had paroxysmal AF; 57% had persistent or long-standing persistent AF and 39% had experienced a prior hospitalisation for AF. The primary endpoint of the trial (the composite of all-cause mortality, disabling stroke, serious bleeding, Continued on page 2

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Novel anticoagulants associated with lower all-cause mortality compared to VKAs Continued from page 1

There was a similar proportion of deaths from cardiovascular events, such as heart failure, and non-cardiovascular causes, such as cancer. In 29.1% of cases, cause of death was unknown.

Further results from GARFIELDAF were announced at ESC. Keith Fox (University of Edinburgh, Scotland, UK) presented an analysis of 25,815 patients that showed patients with new onset AF and no prior anti-platelet therapy or anticoagulation, those patients that received anticoagulation and anti-platelet therapy at the time of AF diagnosis have had a worse prognosis than those on anticoagulation alone. Overall, treatment with anticoagulants and antiplatelet therapy compared to anticoagulants alone was associated with increased risks of major bleeding (adjusted HR: 1.45; 95% CI: 0.94, 2.23) and all-cause mortality (adjusted HR: 1.31, 95% CI: 1.05, 1.62) without a

reduction in stroke (adjusted HR: 1.60; 95% CI: 1.08, 2.35).

Nearly all patients diagnosed with atrial fibrillation should be started on oral anticoagulation to prevent stroke, according to 2016 ESC Guidelines for the management of atrial fibrillation developed in collaboration with European Association for Cardio-Thoracic Surgery (EACTS).

The addition of platelets was said to increase the risk of bleeding, and was not recommended unless required to prevent coronary or peripheral artery thrombosis, such as in patients who have received a stent, had a myocardial infarction, or have peripheral arterial disease.

The global scope of the GARFIELD-AF registry in patients with newly diagnosed AF also provided an opportunity to evaluate whether the actual dosing of NOACs in real-life conforms to the approved dosing regimen (based on country-specific guidelines for each NOAC for stroke

Relative effectiveness of oral anticoagulants in reducing all-cause mortality over time since start of treatment Patients with a CHA2DS2-VASc score ≥2 (including gender) Patients stratified according to the first OAC after diagnosis of AF Follow-up

OAC vs no Anticoagulant P-value

HR (95% CI)

P-value

3 months

0.54 (0.43, 0.68)

<0.001

0.54 (0.43, 0.68)

0.014

12 months

0.76 (0.66, 0.86)

<0.001

0.54 (0.43, 0.68)

0.001

24 months

0.83 (0.75, 0.93)

<0.001

0.54 (0.43, 0.68)

0.001

prevention). In a Rapid Fire session at ESC, John Camm reported that more than 70% of the 10,417 patients treated with NOACs received the correct dose. Exceeding the recommended dose was relatively rare (3.6%, overall), and largely confined to cases where dose-modification was not heeded for moderate-to-severe chronic kidney disease.

For those patients who received nonrecommended low-dose NOACs, all-cause mortality increased by 51% over the first year of follow-up (adjusted HR: 1.51; 95% CI: 1.16, 1.96), compared with patients who received the recommended dose of NOAC for stroke prevention.

GARFIELD-AF is a worldwide

recent European Society of Cardiology Congress (ESC; or cardiac arrest) occurred in 9.2% of patients in the drug 25–29 August, Munich, Germany). group and 8% of patients in the ablation group (intention Crossover was common with 9.2% of patients in the to treat HR: 0.86; 95% CI: 0.65, 1.15; p=0.303). ablation arm not undergoing the procedure and There were also no significant differences in the 27.5% of those in the drug therapy arm ultimately individual components of the primary endpoint. undergoing ablation. Both of these factors would The death rate was 5.2% vs. 6.1% for ablation be expected to dilute any treatment benefit versus drug therapy (HR: 0.85; p=0.38). A produced by ablation. When the investigators secondary composite endpoint of all-cause performed sensitivity analyses on the primary death or cardiovascular hospitalisation favoured intention to treat results using “treatment ablation (51.7% vs. 58.1%; HR: 0.83; 95% received” and “per protocol” definitions CI: 0.74, 0.93). The procedure also reduced of treatment to account for the effect of the recurrence of AF (HR: 0.53; 95% CI: crossovers, significant treatment benefits 0.46, 0.61). Detailed results regarding were seen both for the primary endpoint recurrent arrhythmias, including AF burden (treatment received HR: 0.67; p=0.006) as assessed by serial Holter monitoring Douglas L Packer and for mortality (treatment received HR: during follow-up, were presented at the 0.60; p=0.005).

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Editorial contribution:

Richard Schilling Ross Hunter

Jessica Thompson, Dawn Powell

Scientific advisor:

David Reekie and Naomi Amorra

Andreas Goette

Publisher:

Stephen Greenhalgh

Head of Publishing: Amanda Nieves

Editor:

Hannah Woolley publishing@bibamedical.com

Design

Layout:

Terry Hawes

Advertising:

NOAC vs VKA

HR (95% CI)

CABANA trial provides important new data on clinical and quality of life effects of ablation for atrial fibrillation

Editors-in-chief:

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Research

observational programme that aims to enhance the breadth and depth of understanding of stroke prevention in atrial fibrillation, ultimately informing strategies to improve patient outcomes, safety and utilisation of healthcare resources.

A total of 57,262 patients were recruited from 1,352 centres in 35 countries worldwide, including the Americas, Europe, Africa and Asia-Pacific, over five sequential cohorts. Follow-up takes place over a minimum of two years and up to eight years after diagnosis, to create a comprehensive database of treatment decisions and outcomes in everyday clinical practice.

In an analysis of the quality of life data collected in CABANA, AF patients randomised to ablation compared to drug therapy had incremental, clinically meaningful and significant improvements in AF-related symptoms and quality of life, relative to drug treatment, and the benefit was sustained over five years’ follow-up. In addition, both groups showed substantial improvements over the first 12 months, which were sustained for five years. These quality of life results were also presented at the ESC. As in any unmasked trial, post-randomisation treatment biases might have affected the trial outcomes. While the reductions in the primary endpoint and in overall mortality produced by ablation were not statistically significant, the results were affected by the large number of treatment crossovers and by lower than expected event rates. The significant reduction in recurrent arrhythmias and the important improvement in quality of life with ablation (assessed by intention-to-treat), and the absence of safety concerns with ablation provide new and important information on the benefits of catheter ablation for treating patients with atrial fibrillation like those enrolled in CABANA.

Please contact the Cardiac Rhythm News team with news or advertising queries

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Advertorial

3

Case report: Mapping a complex macroreentrant atrial arrhythmia in congenital heart disease after surgical Cox-Maze operation using the Abbott Advisor HD Grid™ catheter

By Philip L Wackel and Bryan Cannon, both paediatric cardiologists from the Mayo Clinic, Rochester, USA Case description

A 31 year-old female with tricuspid atresia and normally related great vessels who underwent an atriopulmonary Fontan (total cavopulmonary anastomosis) at two years of age and a subsequent Fontan revision to a fenestrated lateral tunnel Fontan with a biatrial cut-and-sew modified Cox-Maze operation (both left and right atrial lines) at the age of 11, presented with recurrent intra-atrial reentrant tachycardia refractory to dofetilide and anti-tachycardia atrial pacemaker therapy. She was taken to the electrophysiology lab to attempt an ablation due to the refractory nature of her tachycardia and symptoms related to the tachycardia. The tachycardia was induced and then mapped using the Abbott Ensite Precision Cardiac Mapping System™. With the use of an Agilis™ sheath and the Advisor HD Grid™ catheter, we created a high density voltage and timing map both inside the lateral Fontan circuit (referred to as the right atrium) and in the left atrium through the Fontan fenestration.

The map was created using the novel HD Wave Grid map which reduced overestimating areas low voltage by taking the highest overall voltage across the Grid electrode pairs.

The map included 197,352 points taken with the Advisor HD Grid™ and FlexAbility SE™ catheters.

Signals were measured within a window of interest spanning 98% of the tachycardia cycle length. Surface score matching was used to eliminate inclusion of far-field ventricular signals.

Cycle length stability filtering was set to +/-10ms. The absolute peak of the bipolar signal within the window of interest was used for timing annotation, which allowed for rapid identification of near-field activation in zones with conduction block and wave front collision, and no manual annotation was required. In addition, fewer than 50 points required editing. These points were used for voltage and timing

1 Figure 1: Pre-ablation voltage map in RAO 30 and left lateral. Data collected with Advisor HD Grid with HD Wave voltage presentation.

Figure 2: Zone of slow conduction denoted by black arrow. This area is defined as having >3 isochronal timing bands in a space <1cm.

2 assessment.

We identified multiple lines of conduction block, numerous areas of slow conduction, and several bystander wave fronts that encompassed the entire cycle length of the tachycardia in both the right and the left atria. A wave front utilising a narrow corridor in the mitral isthmus was ultimately identified and ablated, resulting in clean termination of the tachycardia and non-inducibility of any further tachycardia.

Summary

This case highlights the ability and utility of the Advisor HD Grid™ catheter and mapping system to rapidly map atrial arrhythmias in complex congenital heart disease following prior surgical ablation. The ability to rapidly map multiple chambers of the heart with high fidelity may increase the success rate of ablations in patients

with challenging anatomy due to congenital heart disease.

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.

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Cardiovascular disease

Ablation and CRT superior to medical therapy in reducing heart failure and hospitalisation A recent randomised controlled trial has found ablation and cardiac resynchronisation therapy (CRT) to be superior to pharmacological therapy in reducing heart failure and hospitalisation in elderly patients with permanent atrial fibrillation and narrow QRS. The findings were presented by Michele Brignole (Ospedale di Lavanga, Lavanga, Italy) at the European Society of Cardiology Congress 2018 (ESC; 25–29 August, Munich, Germany) and simultaneously published in the European Heart Journal.

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rignole and colleagues aimed to test the hypothesis that atrioventricular (AV) junction ablation in conjunction with biventricular pacing (CRT) is superior to pharmacological rate-control therapy in reducing heart failure and hospitalisation in patients with permanent atrial fibrillation and narrow QRS. The investigators carried out a randomised controlled trial, assigning 102 patients (mean age 72±10 years) to either the ablation and CRT arm (with the addition of implantable cardioverter defibrillator [ICD] according to guidelines) or the control drug arm (including ICD also). The randomised patients met the required criteria: severely

symptomatic permanent fibrillation (>six months), narrow QRS (≤110ms), and at least one hospitalisation for heart failure in the previous year to AV junction ablation and CRT (plus defibrillator according to guidelines) or to pharmacological ratecontrol therapy.

Patients were stratified by centre and by an ejection value of 35%. Follow-up was carried out at 30 days for treatment optimisation, at one year for a quality of life assessment, and again at two years (with the mean follow up being 16 months). The two groups were matched at the time of enrolment on factors such as symptoms and physical capacity, as well as their history of

atrial fibrillation and both electrocardiogram and echocardiogram results.

The primary outcomes measured were death or hospitalisation due to heart failure, or worsening heart failure. Secondary outcomes included death from any cause, hospitalisation for heart failure, symptoms and physical limitations.

Regarding the results for this primary outcome; death or hospitalisation due to heart failure or worsening heart failure had occurred in only 10 patients (20%) in the ablation and CRT arm, compared with 20 patients (38%) in the drug arm (HR: 0.38; 95% CI: 0.18, 0.81; p=0.013).

Furthermore, significantly fewer patients in the ablation and CRT arm died from any cause or underwent hospitalisation for heart failure (six [12%] vs. 17 [33%]; HR: 0.028; 95% CI: 0.011, 0.72; p=0.008), or were hospitalised for heart failure (five [10%] vs.

13 [25%]; HR: 0.30; 95% CI: 0.11, 0.78; p=0.024).

In comparison with the drug arm, the patient group receiving ablation and CRT

showed a 36% reduction (a significant decrease, p=0.004) of specific symptoms and physical limitations of atrial fibrillation at the one-year follow-up.

These results show that in elderly patients with permanent atrial fibrillation and narrow QRS, atrioventricular junction ablation in conjunction with CRT reduced the risk of death or hospitalisation due to heart failure, as well as worsening of heart failure by 62%, while it improved specific symptoms of atrial fibrillation by 36%.

Additionally, while the reduction of heart failure and hospitalisation was more marked in patients with reduced ejection fraction, both symptoms and physical limitations improved more in patients with preserved ejection fractions.

In conclusion, the authors write: “Ablation and CRT was superior to pharmacological therapy in reducing heart failure and hospitalisation and improving quality of life in elderly patients with permanent atrial fibrillation and narrow QRS.”

New guidelines for cardiovascular disease management during pregnancy: Risk-dependent action plans and upgraded recommendations of catheter ablation New guidelines for the management of cardiovascular diseases during pregnancy, including upgraded recommendations of catheter ablation and risk-dependent action plans, were presented by Carina Blomström-Lundqvist, Uppsala University, Uppsala, Sweden, at the European Society of Cardiology Congress (ESC; 25–29 August, Munich, Germany).

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ccording to Blomström-Lundqvist, atrial fibrillation (AF) and paroxysmal supraventricular tachycardia (PSVT) are the most frequent arrhythmias in pregnancy; however, both are usually benign and can be treated effectively.

Regarding pre-pregnancy recommendations, Blomström-Lundqvist stressed their importance, noting that risk assessments and counselling should be offered to all women with known or suspected congenital or acquired cardiovascular and aortic disease, as an implantable cardioverter defibrillator (ICD) or ablation may need to be considered. Furthermore, she stated that risk assessments are recommended in all women with cardiac diseases of childbearing age after conception. She emphasised that once the women become pregnant, it is important to plan for the medication treatment during pregnancy—especially in relation to channelopathies.

Discussing the acute management of supraventricular tachycardia (SVT) and AF for PSVT, BlomströmLundqvist noted that the class 1 recommendation is for vagal manoeuvres, followed by adenosine if these are to fail. Additionally, for tachycardias that are haemodynamically unstable, including patients with pre-excited AF, electrical cardioversion is the first line of choice. The method is seen as safe, as foetal blood flow is not compromised, there is a low risk of foetal arrhythmia, and foetal heart rate should be controlled after the cardioversion.

If the first line of drugs fail, beta-1-selective blockers should be considered for acute conversion of PSVT (class IIa indication), while in selected cases, ibutilide or flecainide may be considered for termination of atrial flutter and AF in stable patients

with structurally normal hearts.

In relation to long-term management of SVT and AF, beta-blockers or calcium channel blockers are recommended for the prevention of SVT, provided the patient has no pre-excitation on resting ECG. Flecainide or propafenone are recommended for the prevention of SVT in patients with Wolff-ParkinsonWhite syndrome. Blomström-Lundqvist acknowleged that although beta-blockers would be first choice, diagoxin and verapamil (unless there is preexcitation on ECG) could be used for rate control of atrial tachycardia or AF, as well as catheter ablation, provided the centre has a high level of expertise using the electroanatomical system for cases of drugrefractory and poorly tolerated SVT. Regarding the acute management of ventricular tachyarrhythmias (VT), electrical cardioversion is again preferred for both unstable and stable VT. ICD is preferably recommended prior to pregnancy for patients with a clinical indication in the long-term management of VT or ventricular fibrillation, but is also possible during pregnancy—preferably using echo-cardiographic guidance or mapping. Beta-blocking agents are recommended to be continued during pregnancy and post-partum in patients with long QT syndrome or catecholaminergic polymorphic VT. With respect to the new 2018 guidelines, Blomström-Lundqvist stated that they have upgraded the recommendation of catheter ablation for SVT. Specifically, common types such as atrioventricular nodal re-entrant tachycardia and tricuspid atrial flutter have been upgraded from IIb to IIa. During the presentation, Blomström-Lundqvist pointed to surveillance levels at time of delivery in

women with arrhythmias. She explained that physicians should first classify the patient within the three levels of risk for arrhythmia (low, medium or high), given the provided definitions, then take action dependent on the surveillance level; another new recommendation included in the guidelines. She gives the example: if a patient belongs to the low-risk group, physicians should consult a cardiologist, whereas if the patient belongs to the medium or high risk, a consultation with a multidisciplinary team including arrhythmologists at a specialised centre should be arranged. Furthermore, caesarean delivery is recommended if a patient has a very high risk, as well as arterial line.

Other examples included that medium to high-risk patients should undergo an intravenous administration of a beta-blocker, as well as the potential delivery at a thoracic operating theatre, and even preparations for transfer to a cardiac intensive care unit post-partum (for high-risk patients) if necessary.

Physicians should first classify the patient within the three levels of risk for arrhythmia (low, medium or high)... then take action dependent on the surveillance level.

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Accelerometer-based atrial sensing significantly improves atrioventricular synchrony with leadless ventricular pacemaker Accelerometer-based atrial sensing is feasible and significantly improves atrioventricular synchrony (AVS) in patients with atrioventricular (AV) block and a single-chamber leadless pacemaker implanted in the right ventricle, concludes the Micra atrial tracking using a ventricular accelerometer (MARVEL) clinical study.

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n investigational algorithm, using the accelerometer signal in the Micra Transcatheter Pacing System (TPS; Medtronic) may restore AV synchrony, improving cardiac function in patients with sinus rhythm and atrioventricular (AV) block.

The results were presented during a late-breaking session at Heart Rhythm Society's Scientific Sessions 2018 (HRS; 9–12 May, Boston, USA), and simultaneously published in the journal Heart Rhythm.

“The results of MARVEL indicate that this novel mechanical sensor may allow more patients to benefit from a miniaturised leadless pacemaker,” says Larry Chinitz (NYU Langone’s Heart Rhythm Center, New York City, USA), MARVEL study principal investigator. “Although single-chamber pacing in the ventricle is quite safe for these patients, the preferred option is to treat them with a wired pacemaker in two chambers to maintain synchrony and cardiac function. However, patients with these traditional pacemakers are at risk of experiencing complications related to the pocket and the leads, and leadless pacemakers removes the risks.”

The Micra Accelerometer Sensor Sub-Study (MASS) and MASS2 early feasibility studies showed intracardiac accelerations related to atrial contraction can be measured via ACC in the Micra leadless pacemaker.

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Implantable devices

The MARVEL study was a prospective multicentre study designed to look at the closed-loop performance of an AV synchronous algorithm downloaded into previously implanted Micra devices. Atrioventricular synchrony was measured during 30 minutes of rest and during VVI pacing. AVS was defined as a P wave visible on surface electro-cardiogram followed by a ventricular event <300ms.

The MARVEL study evaluated 64 patients who already had a Micra TPS at 12 centres in nine countries.

Investigators evaluated the ability for the Micra’s accelerometer to monitor and detect contractions in the atrium, even though the device is implanted in the ventricle. Investigators also evaluated Micra’s ability to pace the ventricle to contract in sequence with the atrium, creating AV synchrony.

AV synchrony was measured using continuous device telemetry and an electrocardiogram via a Holter monitor.

The study showed the percentage of AV beats in synchrony during pacing with the AV algorithm was 87% among

all study patients (while they were at rest for 30 minutes), 80% in highdegree AV block patients, and 94.5% in patients with predominantly intact AV conduction during the study. In patients with high-degree AV block who would benefit the most from AV synchrony, the algorithm yielded significantly greater AV synchrony (p<0.001) compared to VVI pacing without the algorithm. In addition, AV block patients had a statistically significant improvement (p=0.004) in stroke volume (blood flow out of the left ventricle) during AV algorithm pacing (23.9cm Left ventricular outflow tract velocity time integral [LVOT VTI]) compared to VVI pacing (21.8cm).

Results also presented at the Heart Rhythm Society’s 2018 meeting from the Micra Post-Approval Registry demonstrated major complications with Micra TPS were infrequent with a 63% lower risk for major complication (p<0.001) compared to traditional pacing systems.

Micra

Study confirms feasibility of extravascular approach to ICD therapy Results demonstrating the feasibility of a novel approach to delivering pacing and defibrillation therapy in which a lead is placed under the sternum, outside of the heart and veins were presented during a late-breaking session at Heart Rhythm Society's Scientific Sessions 2018 (HRS; 9–12 May, Boston, USA).

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he Acute Extravascular Defibrillation, Pacing and Electrogram (ASD2) study was the first in-human research study of pacing, sensing and defibrillation from a lead designed specifically for the substernal space.

The results of the international ASD2 feasibility study confirmed that an investigational extravascular ICD lead can sense, pace and defibrillate the heart. This offers a potential future alternative to traditional transvenous ICD systems.

“Clinicians are highly interested in the potential for an extravascular ICD solution to provide both pacing and lifesaving defibrillation therapy without leads placed inside the heart or vasculature,” said Lucas V A Boersma, St Antonius Hospital, Department of Cardiology, Nieuwegein, the Netherlands and professor of cardiology, Academic Medical Center (AMC),

University of Amsterdam, the Netherlands. “The ASD2 study offers very encouraging clinical insights, which bring us closer to implanting the first chronic investigational system in ambulatory patients.”

The EV-ICD System is a new approach to implantable defibrillation therapy that may offer the benefits of current transvenous defibrillators. Current subcutaneous ICDs (S-ICDs) were developed to overcome the risk of transvenous ICDS but are limited in the bradycardia pacing support they can offer. S-ICDs also have no antitachycardia pacing and need a high input for defibrillation and are relatively large in size compared to transvenous ICDs. In ASD2, 79 patients who were already scheduled for elective cardiac surgery or a subcutaneous or transvenous ICD implant had an investigational EVICD lead inserted temporarily under the sternum and

evaluated in conjunction with either a defibrillation patch or a defibrillator emulator. The ICD lead was designed to sense activity in the ventricles (lower chambers of the heart), provide pacing to the ventricles, and deliver a 30-joule defibrillation shock after ventricular fibrillation (VF) was induced.

Ventricular pacing was successful in 97% of patients, and shocks successfully terminated 83% of episodes, consistent with prior clinical studies of existing ICDs. The average lead placement time was 12±9 minutes Seven adverse events were reported in six of the 79 studied patients. As with any feasibility research evaluating a new procedure, the investigational procedure and lead implantation tools were refined during the study, with further technique training and education provided to all investigators in an effort to reduce the adverse event rate in future patients.

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Advertorial

7

Case report: Successful use of the Evolution RL rotational extraction sheath without the PTFE-outer sheath in a right-sided transvenous lead extraction procedure By Prof Dr Christoph T Starck, FEHRA

W

e report the case of a 74-year old-male patient with a cutaneous device perforation due to a pocket infection of a dual chamber pacemaker system. Eleven years ago the patient received the right-sided dual chamber pacemaker implantation due to third degree AV block. Four years ago a device exchange was performed due to battery depletion. The patient was referred to our centre for complete device removal.

On admission routine preoperative diagnostics for lead extraction patients were carried out. In echocardiography large lead vegetations were ruled out.

Pre-operative chest X-ray showed an active fixation right atrial and right ventricular lead with lead-leadinteractions in the area of the superior vena cava (Figure 1). Device interrogation showed that the patient was pacemaker dependent with an insufficient spontaneous rate. Intracardiac electrogram of the right-atrial lead revealed atrial fibrillation at the present interrogation.

After routine pre-operative preparation and with informed consent the patient underwent explantation of the right-sided dual chamber pacemaker and implantation of an epicardial right ventricular lead via a subxiphoidal approach. The epicardial lead was connected to a dual chamber pacemaker placed in a subcutaneous device pocket in the left subclavicular region to allow for transvenous implantation of a right atrial lead in the further course if needed due to intermittent recovery of sinus rhythm. The procedure was performed under general anaesthesia, in stand-by of extracorporeal circulation and in a hybrid operating room. Despite extensive fibrotic adhesions both leads were successfully extracted using a Liberator Locking stylet (Cook Medical), a One-Tie compression coil (Cook Medical) and the Evolution RL bidirectional rotational extraction sheath (Size 11F, Cook Medical).

Due to the right-sided implant, the Evolution RL sheath was used without the outer sheath, in order to allow for more flexibility of the rotational extraction sheath resulting in better coaxial alignment to the targeted leads. The extraction procedure was performed successfully and safely without any complications.

The patient recovered well from the procedure and was discharged from our hospital on the second postoperative day.

Discussion

Transvenous lead extraction procedures can be performed safely and effectively with current lead extraction tools even in challenging cases. The Evolution RL bidirectional rotational mechanical extraction sheath has shown excellent results with high clinical success rates (>95%) and low complication rates, even in challenging cases.1,2 The Evolution RL mechanical extraction sheath system is consisting of the bidirectional rotational extraction sheath itself and a PTFE outer sheath. Many operators use the Evolution RL sheath exclusively together with the outer sheath. However, just because the extraction tool is delivered with an outer sheath, does not imply that it has to be used together with it in all cases. In fact, in select cases the use of the Evolution RL system without the outer sheath will reveal advantages to the patient. One such case is an extraction of leads implanted via the right subclavian vein. The challenge in such situations is an acute angle at the junction of the right subclavian vein and the superior vena cava, which often leads to suboptimal coaxial alignment of extraction sheaths. If coaxial alignment to the targeted lead is lost during transvenous lead extraction procedures, the risk of damage to the lead or adjacent anatomical structures increases dramatically.

Therefore coaxial alignment in such situations is highly desirable and it is evident that increased flexibility of an extraction tool while maintaining adequate transduction of advancing forces is beneficial. This can be achieved by the use of the Evolution RL extraction sheath without the outer PTFE-sheath. Table 1 shows the implications and potential benefits of the Evolution RL use with and without outer sheath.

References 1. Starck CT, Steffel J, Caliskan E, Holubec T, et al. Clinical performance of a new bidirectional rotational mechanical lead extraction sheath. Europace. 2015.

2. Sharma S, Ekeruo IA, Nand NP, Sundara Raman A, Zhang X, Reddy SK, Hariharan R. Safety and Efficacy of Transvenous Lead Extraction Utilizing the Evolution Mechanical Lead Extraction System: A Single-Center Experience.

JACC Clin Electrophysiol. 2018;4:212–220.

Evolution RL use with outer sheath

Evolution RL use without outer sheath

Less flexible

More flexible (esp. Evolution RL 13F)

Left-sided extraction

Right-sided extraction

Protection of adjacent structures (vessel wall, leads)

Extraction of CS leads

Dense fibrosis: Outer sheath enables rotation of Evolution inside

Dense fibrosis: Rotation may become hard/impossible

Venous occlussion (“Extraction for Recanalization”) Optional: Steady sheath (“Cut-with-fork-principle”) “Manage the last centimeter”: Finish extraction with the outer sheath (Evo 13F, Avoid upsizing) (Snow plowing, Sleeve effect) Table 1: Implications and potential benefits of the Evolution RL use with and without outer sheath.

Figure 1: Pre-operative chest X-ray showing a right-sided dual chamber pacemaker system with an active fixation right atrial and right ventricular lead.

The image reveals a medial puncture of the right subclavian vein, an acute angle of the lead course into the superior vena cava (SVC) and lead-leadinteractions of both leads in the area of the SVC.

Figure 2: Intra-operative fluoroscopy image showing the use of the bidirectional rotational Evolution RL mechanical extraction sheath (Size 11F, Cook Medical) without its outer sheath. This technique allows for more flexibility of the tool while maintaining adequate transduction of advancing forces.

This results in optimal coaxial alignment of the tool without the need for extensive traction forces in right-sided extractions, minimising the risk for collateral damage of adjacent anatomical structures or the targeted lead.

Summary

This case report supports the published excellent clinical results of the Evolution RL extraction sheath (Cook Medical), even in leads with long implant durations.1,2 Furthermore, it demonstrates the successful use of the bidirectional rotational extraction sheath Evolution RL (Cook Medical) without its outer sheath, as a beneficial variation in the use of this tool.

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Atrial arrhythmias

Data suggest atrial flutter should be treated similarily to atrial fibrillation for preventing ischaemic stroke A nationwide cohort study carried out by Yu-Sheng Lin and colleagues reported that the incidence of ischaemic stroke among patients with atrial flutter was significantly lower than those with atrial fibrillation and a CHA₂DS₂-VASc score of >5. The findings, published in the Journal of the American Medical Association, suggest the current recommended CHA₂DS₂-VASc score of ≥2—currently used as a threshold for preventing ischaemic stroke in patients with atrial flutter—should be re-evaluated.

A

ccording to the Lin et al, atrial fibrillation (AF) and atrial flutter (AFL) are similar in that their incidence increases with age, while both contribute to heart failure, stroke and all-cause mortality. Pharmacologic management of AFL is therefore usually considered to be the same as for AF, especially for preventing thromboembolic events. Furthermore, the two are often grouped together in relation to risk stratification and in epidemiologic studies; irrespective of the incidence of AFL being approximately one-sixteenth that of AF, according to the authors.

Although AF and AFL share risk factors for occurrence, differences in clinical outcomes have been reported. For example, previous studies have reported a higher incidence of mortality among patients with AF (as opposed to AFL), while another found a lower incidence of stroke among patients with solitary AFL. The CHA2DS2-VASc score remains the standard scoring system for risk stratification to predict thromboembolic events in patients with AF and AFL, while providing a means of stratifying the risk of hospitalisation for heart failure and mortality in these patients.

The authors write: “On the basis of the distinct underlying electrophysiologic mechanisms and myocardial substrates of AFL and AF, the incidence of ischaemic stroke, hospitalisation for heart failure, and all-cause mortality would be expected to be different across different levels of

Yu-Sheng Lin

CHA2DS2-VASc score.”

This led Lin et al to carry out a nationwide cohort study analysing data from the Taiwan National Health Insurance Research Database from January 2001 to December 2012. Clinical outcomes, including ischaemic stroke, heart failure hospitalisation and allcause mortality among the AF, AFL and matched control cohorts were analysed and compared following stratification by CHA2DS2-VASc score.

A total of 219,416 age- and sex-matched individuals participated in the study: comprised of 188,811 patients in the AF cohort (mean age: 73.8 years; 55% male), 6,121 patients in the AFL cohort (mean age: 67.7 years; 61% male) and 24,484 patients in the matched control cohort (mean age: 67.3; 61% male). Baseline characteristics revealed that patients with AF and AFL had significantly higher

prevalence rates of comorbidities compared with matched control individuals.

The clinical outcomes in the three groups (AF, AFL, and control cohorts) were compared across different CHA2DS2VASc levels; with their risk expressed as incidence densities (defined as the number of events per 100 person-years). The lowest score is zero and the highest score is nine in the CHA2DS2-VASc scoring system, with higher scores indicating greater risk of ischaemic stroke.

Indeed, the incidence densities of ischaemic stroke were 3.08 (95% CI: 3.03, 3.13) for the AF cohort, 1.45 (95% CI: 1.28, 1.62) for the AFL, and 0.97 (95% CI: 0.92, 1.03) for the matched controls. Regarding heart failure hospitalisation, the incidence densities were as follows: 3.39 for the AF cohort (95% CI: 3.34, 3.44), 1.57 (95% CI: 1.39, 1.74) in the AFL cohort, and 0.32 (95% CI: 0.29, 0.35), for the control group.

For the all-cause mortality outcome, the incidence densities were 17.8 (95% CI: 17.7, 17.9) in the AF cohort, 13.9 (95% CI: 13.4, 14.4) in the AFL cohort and 4.2 (95% CI: 4.1, 4.4) for controls.

These results show that after stratification by the CHA2DS2-VASc score, the incidence densities for all three main outcomes were significantly higher in the AF cohort than in the matched control group. Additionally, for the AFL cohort versus the matched control cohort, the incidences of heart failure hospitalisation and all-cause mortality were significantly higher across all levels, but the incidence

of ischaemic stroke was only significantly higher in those patients with a CHA2DS2VASc scores of 5–9.

Furthermore, when directly comparing the AF cohort to the AFL cohort, the authors found the incidences of ischaemic stroke and heart failure hospitalisation were significantly higher at a CHA2DS2VASc score of one or higher. However, the incidence of all-cause mortality was significantly higher only at CHA2DS2VASc scores of 1–3.

Evaluating their study, Lin et al note a few limitations of their research. As they only enrolled Taiwanese participants, further study is needed to find out whether these results could be extrapolated to non-Asian populations. Additionally, non-randomised observational studies are prone to residual confounding, yet the authors write that the falsification analysis revealed no strong evidence of confounding in the comparison between the AF and AFL groups.

The authors conclude that the results of this study—in line previous literature—go against the current guidelines that suggest patients with AFL should be treated in the same manner as patients with AF for preventing ischaemic stroke. Instead, the Lin et al note, the results suggest that the efficacy and safety of oral anticoagulants to reduce ischaemic stroke in patients with AFL with the currently recommended CHA2DS2-VASc score (of ≥2) should be re-evaluated; reiterating the need for further prospective studies to be carried out.

Continuous home-based monitoring results in significantly higher rate of atrial filbrillation diagnosis The mHealth Screening To Prevent Strokes (mSToPS) randomised clinical trial showed that home-based wearable electrocardiogram (ECG) sensor patch monitoring, compared with delayed monitoring, resulted in a higher rate of atrial fibrillation diagnosis after four months. Wearing an ECG patch (Zio, iRhythm) for two weeks was equivalent to 12 months of fortnightly monitoring.

F

or approximately 20% of individuals who experience a stroke due to atrial fibrillation, the occurrence of atrial fibrillation (AF) was not diagnosed until the time of their stroke or shortly afterward. Improved AF diagnosis and treatment could reduce the risk of stroke.

The study looked at 2,659 individuals with an increased risk of AF and compared immediate monitoring using a self-applied ECG patch to delayed ECG monitoring for four months. The results showed a significantly higher rate of AF diagnosis at four months in the wearable ECG cohort compared to the delayed ECG cohort (3.9% vs. 0.9%).

At one year, primary results showed that AF was newly diagnosed in 6.7% of patients who were actively monitored by the home based wearable ECG monitor versus 2.6% in the observational control group receiving routine care. In addition, 4% of patients in the homebased ECG monitor group were found to have potentially actionable arrhythmias other than AF including ventricular tachycardia, pause, atrioventricular block, and symptomatic supraventricular tachycardia.

“Our study shows an almost threefold improvement in the rate of diagnosis of AF in those actively monitored compared to usual care,” said Steven Steinhubl, director of digital medicine at Scripps Translational Science Institut and associate professor at The Scripps Research Institute (La Jolla, USA). “Diagnosing AF more effectively can enable the initiation of effective therapies and help reduce strokes and death.”

Continuous home based ECG monitoring led to significant change in clinical treatment of the actively monitored group including initiation of anticoagulation therapies (5.7%), antiarrhythmic medications (0.8%), and pacemaker placement (0.8%). Patients receiving anticoagulation for AF appeared to fulfil current clinical guidelines for appropriateness and need. Mean wear time for the ECG patch was 12 days with 98% analysable ECG data.

One-third of individuals were enrolled via a web-based platform to undergo either immediate or delayed active ECG monitoring at home for up to four weeks with a

Zio XT patch monitor (two-week monitoring periods spaced four months apart). Each monitored participant was matched with two non-monitored participants with a similar CHA2DS2-VASc, a standardised stroke-risk assessment score, to act as controls. The study looked at time to first diagnosis of AF and its clinical consequences for the active monitoring cohort as well as the cohort undergoing usual care.

Commenting on these findings in an editorial in JAMA, Benjamin Steinberg and Jonathan Piccini (University of Utah and Duke University, USA) write that the data suggest "immediate, continuous screening for two weeks may be equivalent to weekly or biweekly, 30-second rhythm monitoring over a 12-month period in a population of similar risk. This is further supported by the timing of detection in the mSToPS cohort: among patients with AF detected on two-week monitoring, nearly one-quarter had AF on day one and nearly 40% had AF detected within the first three days—including both the early and delayed active monitoring groups.”

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LVAD

9

ADVERTORIAL

LVAD technology improves, providing better, longer-term outcomes Left ventricular assist devices (LVAD) are mechanical pumps that are implanted inside a person's chest to help their weakened heart ventricle pump blood throughout the body. The mechanical device supports the left heart chamber that pumps blood through the body.

U

nlike an artificial heart, a LVAD assists the heart instead of replacing it. This is a life-saving therapy for patients awaiting a heart transplant and is termed “bridge-totransplant”. Patients use the LVAD until a heart becomes available and, in some cases, the LVAD is able to restore the failing heart, eliminating the need for a transplant.

LVADs may also be used as destination therapy, which is an alternative to transplant. Destination therapy is used for long-term support in some terminally ill patients whose condition makes them ineligible for heart transplant.

LVADs have been shown to be effective in patients with end stage heart failure who are unable to receive a heart transplant. Patients receiving LVADs can suffer from cardiac rhythm disorders.

Permanent treatment with continuousflow LVAD has been shown to improve survival and quality of life compared to drug therapy alone.1 Since the first LVAD device was implanted in a 37-year-old woman in 1966, LVADs have been improving patient outcomes.2 The Abbott HeartMate 3™ LVAD assists the heart in pumping blood around the body, increasing the oxygenation of organs. The device has Full MagLev™ Flow Technology, which provides better blood handling and reduces complications such as pump thrombosis, stroke and haemolysis. Two-year results from the Momentum 3 trial have shown superior survival free of disabling stroke or reoperation, with the overall rate of stroke being lower with HeartMate 3™ LVAD centrifugal-flow pump group when compared to the axial flow pump group.3 Reoperation for pump malfunction was also 90% less frequent for the HeartMate 3™ centrifugal-flow pump group than in the axial-flow pump group.

The HeartMate 3™ LVAD is the first implantable, continuous-flow heart pump that uses unique full magnetic levitation without the need for hydrodynamic contribution and has

wide blood-flow passages to reduce shear stress, is essentially frictionless with no mechanical bearings and produces an intrinsic pulse to reduce stasis and avert thrombosis.4,5 Cardiac Rhythm News spoke to consultant cardiologist Steven Shaw (University of Manchester, UK) about what LVAD devices can offer.

How does the HeartMate 3TM device differ from other devices and what does the latest clinical evidence teach us?

The design of the pump in the HeartMate 3™ [device] is rather unique and has been designed to minimise complication rates. The rotor is fully levitated in a magnetic field, which means it is essentially frictionless.

The latest evidence (which comes from one of the largest ever research study of LVADs) shows that the risk of stroke has been halved [10.1% vs.

19.2%] compared to its predecessor (the HeartMate IITM device) and that blood clots within the pump have been almost completely abolished.3

LVADs offer support to patients with severe heart failure. How do they work?

To put it simply, LVADs take blood from the left ventricle that has not enough strength anymore and return it to the main artery of the body. This aims to restores an adequate cardiac output for the patient.

Which patients might receive or benefit from an LVAD device?

Patients with advanced heart failure due to severe left ventricular impairment are considered for LVADs. In the UK National Health Service (NHS), we are commissioned to implant them in patients who need a heart transplant but haven’t got time to wait. They can help to prolong life and restore a better quality of life in these patients. Indeed, it is now common for LVADs to be able to support patients for a time period measured in years.

Who is referring patients for LVAD implantation and when should a patient be referred?

Most patients get referred by their local consultant cardiologist or heart failure specialist nurse. Patients should be referred to an advanced heart failure centre if they remain symptomatic despite best efforts with conventional treatment, or there are signs of poor prognosis such as recurrent hospital admissions, high diuretic requirement, high B-type natriuretic peptide levels, kidney or liver impairment, high pulmonary pressure, etc. We prefer patients to be referred earlier rather than later.

HeartMate 3TM device in patient

Are there selection criteria to identify which patients are suitable?

Selection is a very complex process that is the responsibility of a transplant multidisciplinary heart failure team.

Eligibility is based on whether the patient is regarded a transplant candidate. Suitability is defined by detailed tests which include imaging, a haemodynamic study of the heart (a right heart catheter) and blood tests.

What are the drawbacks of LVAD devices?

The cost is high, which means the selection criteria in the NHS is strict and we cannot therefore implant everyone we could otherwise. There are some important lifestyle limitations. You cannot perform contact sports, you cannot immerse yourself in water (i.e. go swimming) and you must always be connected to power.

The treatment is not without its risks and complications can happen. Some people have survived over a decade on LVAD support which is fantastic, but overall they are yet to be able to match the long-term outcomes of transplantation.

What is the difference between ‘bridge to transplant’ and ‘destination therapy’?

HeartMate 3TM Device system

heart transplant can be done. Destination Therapy means that the LVAD is intended from the outset to be long-term therapy instead of transplant. The NHS does not fund this indication at present but it is funded in most of the other European health care systems.

Bridge to transplant means we are using the LVAD to keep a patient stable until a

How should the different specialties work together for the best outcomes in LVAD patients?

In Manchester [UK] we have heavily promoted the importance of a multispecialty approach to managing VAD patients. In our outpatient VAD clinics, we encourage cardiologists, specialist VAD nurses, physiotherapists, dieticians, psychologists, and social workers to all collaborate together in a collective effort to aid the recovery and wellbeing of patients. We think this approach is one of the reasons that our outcomes are well recognised.

References 1. Abraham WT, Smith SA. Devices in the management of advanced, chronic heart failure. Nature Reviews Cardiology. 2013;10(2):98-110.

2. Kirklin, JK; Naftel, DC. "Mechanical circulatory support: registering a therapy in evolution". Circulation: Heart Failure. 1 (3): 200–5.

3. Mehra, MR et al.Two-Year Outcomes with a Magnetically Levitated Cardiac Pump in Heart Failure N Engl J Med 2018; 378:1386-1395 4. Heatley G, et al. Clinical trial design and rationale of the Multicenter Study of MagLev Technology in Patients Undergoing Mechanical Circulatory Support Therapy With HeartMate 3 (MOMENTUM 3) investigational device exemption clinical study protocol. J Heart Lung Transplant 2016;35:528-536 5. Schmitto JD, et al. First implantation in man of a new magnetically levitated left ventricular assist device (HeartMate III). J Heart Lung Transplant 2015;34:858860 Abbott The Corporate Village, Da Vincilaan 11 Box F1, 1935 Zaventem, Belgium, Tel: +32 2 774 68 11 SJM.com St. Jude Medical is now Abbott.

Brief Summary: Prior to using these devices, please review the User’s Manual for a complete listing of indications, contraindications, warnings, precautions, potential adverse events and directions for use. ™ Indicates a trademark of the Abbott group of companies. © 2018 Abbott. All Rights Reserved.

28191-EM-HM3-0518-0065 | Information contained herein for use outside the U.S. only. Check the regulatory status of the device in areas where CE marking is not the regulation in force.

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Interview

Profile

Tim Betts For Tim Betts, a career in medicine was a natural choice. After graduating he knew he wanted to be a cardiologist and, with a fascination for arrhythmias and ECGs, he became hooked on electrophysiology. His research is focused on novel ways to improve the implant success and response rates to cardiac resynchronisation therapy (CRT) and was involved in the STAR AF2 trial which showed that there may be no need for additional procedures after a patient with persistent atrial fibrillation (AF) undergoes pulmonary vein isolation (PVI). In this interview he speaks to Cardiac Rhythm News about the challenges and joys he has experienced as an electrophysiologist.

Why did you decide to go into medicine and why, in particular, did you choose to specialise in electrophysiology?

The honest answer about going into medicine is that it was a natural path for those who were doing well at school.

My father was a paediatrician in a university hospital with a very successful clinical and academic career and I am sure that had an influence too; there is a natural instinct to follow in one’s parents’ footsteps. I think it is very difficult for teenagers of 15 and 16 to know what they want to do as a future career, but in the UK that is the point at which you have to start aiming for medical school. I think there is a lot to be said for entering medical school as a graduate in one’s early 20s—although it’s easy for me to say that now!

Specialising in electrophysiology (EP) was a much easier choice. After graduation I knew I wanted to be a cardiologist and was always fascinated by arrhythmias and ECGs. As soon as I saw interventional electrophysiology, I was hooked. The combination of applying logic to solve arrhythmia diagnoses, the practical skills required for catheter manipulation, the ability to dramatically improve young people’s lives with ablation of highly symptomatic supraventricular tachycardia and the rapid growth in technology means that an EP’s practice changes year on year so there is never a dull moment. I must also confess that I quite liked understanding a subject that most people thought was far too complex to take on, even if it labelled me as a “nerd”.

Who are your mentors and what influence have they had on your career?

My number one mentor is professor John Morgan, who introduced me to EP when I was a trainee in Southampton, guided me through my postgraduate research and has also been a role model for how to combine a busy clinical job with research, teaching and working with industry for the greater good. I also spent 18 months in Chicago as an EP Fellow and received wonderfully comprehensive training at Northwestern University under Alan Kadish which set the foundations for how I practice EP today. I should also thank Yaver Bashir, who welcomed me to Oxford 15 years ago and is responsible for the friendly, collegiate, forwardthinking EP Team that I have the privilege to work with today.

What do you consider to have been the biggest development in cardiac rhythm management?

If I have to single one thing out, I think pulmonary vein isolation ablation has had the biggest impact. In many centres it is the most commonly performed procedure.

It has significant financial implications for healthcare purchasers and providers. It is responsible for the rapid growth in the number of EPs. Implantable cardioverter defibrillators (ICDs) and cardiac resynchronisation therapy (CRT) also have to be right up there. The subcutaneousICD has become a regular part of our practice as, being an extraction centre, we are only too familiar with the longterm consequences of transvenous leads.

In Oxford, the development of the Arrhythmia Nurse Specialist has had the greatest impact on cardiac rhythm management (CRM) practice. We have a fantastic team

of experienced cardiac nurses who provide arrhythmia outpatient clinics and telephone consultations. They can prescribe antiarrhythmic drugs and take informed consent.

They also undertake the cardiac physiologist role in the lab, running the EP and 3D mapping systems. They educate colleagues and have a national leadership role. We could not survive without them!

What has been the biggest disappointment?

I am going to say atrial fibrillation ablation again! There have been many small advances over the 20 years I have been performing PVI, such as irrigated-tip radiofrequency ablation, then 3D mapping, then contact force as well as cryoablation and laser, which have made procedures quicker, safer and more effective, yet we are still a long way from perfection. Single procedure AF ablation success rates are disappointing and the best way to ablate persistent AF remains controversial and hotly debated. I suspect that we still do not really have a proper understanding of the electrophysiology behind AF. It is a very heterogenous condition and therapies should be tailored and individualised by understanding the underlying mechanisms. We are only just beginning to realise we need upstream therapies to complement the rather basic approach of burning the left atrium. In that respect, we are years behind our coronary intervention colleagues, who also perform palliative intervention but combine that with statins, antiplatelets, aggressive targeting of comorbidities and adjunctive cardiac medication.

I have also been frustrated by the debate over percutaneous left atrial appendage occlusion. I wish the early random control trials had compared the Watchman (Boston Scientific) to no treatment in people with contraindications to anticoagulation, rather than to warfarin in people without contraindications as that would have answered the questions that have delayed the widespread introduction of this therapy. I believe it is a therapy that can reduce embolic stroke in these vulnerable people who currently have no alternative.

What is the highlight of your career so far?

There is nothing better than a super-responder to CRT. Seeing that someone’s ventricle has normalised and heart failure symptoms have disappeared when they bounce into clinic full of life restores my faith in what we do. I wish it happened more often!

I also love seeing the “lightbulb moment” when teaching on our EP courses. When a student grasps one of the many EP principles, be it entrainment, paraHisian pacing or a device feature or algorithm, it is very rewarding.

What is your current area of research?

At present my research is focused on novel ways to improve the implant success and response rates to CRT. I have developed a technique to puncture the ventricular septum to deliver a left ventricular endocardial pacing lead for people with failed conventional CRT implants.

I am also participating in trials of ultrasound left ventricular stimulation with the WISE-CRT system. This

is a fascinating paradigm shift in how pacing stimulation is delivered and holds a lot of potential.

In my pursuit to understand more about the mechanisms behind AF and how they can be targeted using ablation, I am researching the use of the ACUTUS Medical mapping system. This allows global noncontact mapping of AF to try and identify and target drivers such as focal firing, rotational activity and areas of abnormal conduction.

Our CRM Team also contributes to multicentre commercial studies, including MORE-MPP-CRT, the

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Interview

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Fact File I think pulmonary vein isolation ablation has had the biggest impact. [...] It has significant financial implications for healthcare purchasers and providers. It is responsible for the rapid growth in the number of EPs. PRAETORIAN S-ICD trials and ASAP-TOO.

What are the current challenges in electrophysiology?

We need to get better results and “more bang for our buck”. We need to improve AF and ventricular tachycardia ablation single procedure success rates. We need to have better selection of patients for complex devices and we need to improve CRT response rates and the magnitude of response. As technology advances we need to know how to use it wisely and responsibly in

a cost-effective manner. Having all these challenges is what keeps the job interesting!

Of the research you have been involved in, which piece do you think has had the biggest clinical impact?

We were a big recruiter to the STAR-AF2 trial. Prior to that we would treat patients with persistent AF with extensive ablation including linear lesions and ablation of complex fractionated atrial electrograms. The fact that the trial showed no incremental benefit any ablation above and beyond PVI was sobering. We know perform PVI alone as a standard approach, unless patients are part of a research project. It has made procedures shorter and we do not get nearly so many atypical micro-reentrant atrial tachycardias at re-do procedures, but it presents a dilemma of what to do if there is more AF after successful PVI. I have also become a “high power” ablator PVI after our PiLOT-AF study showed that short-duration, 40W lesions on the posterior LA wall led to fewer oesophageal temperature alerts and superior first pass isolation.

What has been your most memorable case?

You remember a case because it went very well or very badly. I think you learn more from the ones that go wrong because it forces you to evaluate and if necessary change practice. For example, we now perform oesophageal temperature monitoring in every patient undergoing AF ablation ever since a patient died from an atrio-esophageal fistula. There are also the successes, although by definition that usually means they do not return to the clinic to remind you how well they are doing. I still get a Christmas card from the teenager with the paraHisian pathway successfully ablated with cryo after failing at another centre, and a bottle of whisky from the man with the left ventricular endocardial lead implanted through the ventricular septum having failed two conventional procedures who responded so well he is off the transplant list and back at work.

If you had not been a medical doctor, what would you have been?

Well, in my dreams I would have been a rock star, tech billionaire and successful novelist, possibly all three. In reality, I have never given it much thought— which I hope means I have made all the right choices.

Outside of medicine, what are your hobbies and interests?

I run a lot. I love competing in races from 5K to marathons. Age is not a barrier to improvement!

Every now and then I have a moment of madness and enter an ultramarathon. Last year I ran the Comrades in South Africa (88 km uphill) and previously I have run 100 miles non-stop and seven marathons in seven days to raise money for the Oxford Heart Centre. As a result I carried the Olympic flame through Oxford when the 2012 Olympics were held in the UK—my proudest moment!

Current appointments

Consultant in Cardiology and Cardiac Electrophysiology, Oxford University Hospitals NHS Foundation Trust University Research Lecturer, Oxford University Department of Cardiovascular Medicine Clinical & Research Lead, Cardiac Rhythm Management Clinical Service Unit, Oxford University Hospitals NHS Foundation Trust

Education and training

MD (Southampton University, 2003) MBChB (Birmingham University 1991) CCT Cardiology 2003 (Wessex Deanery, UK) Clinical Fellowship in Cardiac Electrophysiology, Northwestern University (Northwestern Memorial Hospital), Chicago, 2001-2 MRCP (London, 1994), FRCP (London, 2010)

Current and recent research

Steering committee member EWOLUTION registry (NCT01972282), CASA-AF (NCT02755688) UK PI for RE-CIRCUIT (NCT02348723), ASAP-TOO (NCT02928497) Local PI for MORE MPP CRT (NCT02006069), PRAETORIAN (NCT01296022), UNCOVER-AF (NCT02825992), CardioMEMS HF System OUS Post Approval Study (NCT02954341), WiCS-LV Post Market Surveillance Registry (NCT02610673)

Professional memberships British Cardiovascular Society British Heart Rhythm Society British Medical Association

Areas of expertise

Cardiac Rhythm Management in adults and children Devices: Brady pacing, ICD’s (including subcutaneous ICD’s), CRT, lead extension Catheter ablation: SVT’s, flutter, ATach, AFib (parox and persistent), VT (including epicardial) Percutaneous left atrial appendage occlusion to prevent thromboembolic stroke

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Remote monitoring

Focus on remote CIED patient monitoring The topic of remote patient monitoring seems to be one receiving close review, which is unsurprising given its scale of benefits, some of which were presented at the European Society of Cardiology Congress 2018 (ESC; 25–29 August, Munich, Germany). Javier GarciaFernández, Hospital Universitario de Burgos (Burgos, Spain), presented findings indicating that remote monitoring reduces in-office evaluations and physician’s workload. Additionally, Mathias Meine, University Medical Center Utrecht (Utrecht, the Netherlands), presented a study that investigated a more direct evaluation of cost-effectiveness. Although no benefits in terms of health status and implantable cardiac device (ICD) acceptance for remote patient monitoring were found in the study, patient satisfaction and cost-benefits were clear, Meine said.

B

oth presenters acknowledged that the surveillance of cardiovascular implanted electronic devices (CIEDs) generates a heavy workload. For example, they provide a burden for inoffice evaluations, not only for the hospital financially— with regards to budgets and staff time—but also from the patient’s perspective.

Garcia-Fernández commented that technological advances in remote monitoring may increase patient safety as they involve longer follow-up times.

Furthermore, according to Meine, evidence shows that remote patient monitoring (RPM) reduces inappropriate ICD therapy, while further analyses indicated that the time to make a clinical decision is shorter in patients with RPM. Another important aspect of RPM, Meine mentioned, is the cost-effective aspect of it. In a metaanalysis conducted by Catherine Klersy et al from Fondazione IRCCS Policlinico San Matteo (Pavia, Italy), analyses found that through RPM, costs can be saved from up to 10–55%. However, important patient outcomes were not evaluated in this trials. This led Meine to question how patients may feel when they are connected to RPM, instead of going into hospital to see an actual cardiologist.

Garcia-Fernández and colleagues conducted a nationwide RM-alone trial, carried out in 16 institutions in Spain. The authors aimed to demonstrate noninferiority of home monitoring only (HMo) compared to home monitoring plus in-office (HM+IO) group, in a long follow-up trial (24 months) using the same remotemonitoring protocol for both pacemakers and ICDs. To investigate efficacy, the authors aimed to examine the reduction of in-office visits in the HMo group compared to the HM+IO group, alongside investigating the reduction of workload of the staff.

Patients (n=445) were enrolled at least three months after implantation and subsequently randomised to the HMo (n=220) or the HM+IO (n=225) group. Followups for both groups occurred at six, 12, 18 and 24 months during face-to-face visits, however, for the HMo group, remote interrogations were performed.

Demographic variables between the two group were evenly balanced, with patients being predominantly male (69.1% and 72.9% in the HMo and HM+IO group, respectively), and the mean age being 69 ±13.3 years, while the prevalence of comorbidities, such as renal failure, heart disease, diabetes, was mostly equal between groups.

In terms of safety, 45 (20.5%) patients in the HMo group and 42 (19%) in the HM+IO group were found to have suffered from at least one major adverse cardiac event, indicating a similar but no statistically significant difference in the rate (p=0.0152), displaying no superiority effect of HM+IO. The Kaplan-Meier survival curves also indicated no difference in the time until first MACE between the two groups.

Regarding efficiency, the number of total in person evaluations was 653 during the two years for the HM+IO group, versus only 136 during follow-up for the HMo group (p<0.001). In contrast to scheduled visits, the number of unscheduled visits were found to be similar within the two groups; 122 and 101 for the overall patient population in the HMo and HM+IO group, respectively.

The mean time for physicians, as well as nurses and technicians, spent on each patient was statistically

lower in the HMo group compared to the HM+IO group (regardless of whether patients had pacemakers or ICDs). Workload of the staff was subsequently analysed using the number of minutes per 100 patients per month. A reduction was observed in the HMo group, as minutes dedicated to patients decreased from 97 to 67 (p=0.018).

Akin to Garcia-Fernández et al’s study, Meine et al carried out the Remote-CEID study; a prospective multicentre randomised controlled trial, designed to study the effect of RPM on patient reported outcomes (health status and ICD acceptance), also with a followup period of two years. Across 32 centres based around Europe, the authors recruited 600 patients (mean age 65), and randomised them into one of two groups: those receiving RPM and in-clinical follow-up once a year, and those receiving in-clinical follow up (as usual care) alone. Meine reported that the baseline characteristics for the patients in each group were more or less equal to other RPM trials, with almost 90% treated with ACE inhibitors and ARBs (angiotensin-receptor blockers), or beta-blockers.

RPM in conjunction with remote interrogation (during follow-up) every six months, was not found to be inferior in terms of safety.

Meine reported that there was no impact of RPM on health status, as the Kansas City Cardiomyopathy Questionnaire (KCCQ) scores did not significantly differ between the two groups. Sub-analyses for physical limitation, symptom burden, selfefficacy, quality of life, and social limitation, also acknowledged no difference between the in-clinic group and the RPM group.

Similar outcomes were observed in relation to ICD acceptance, as there was no significant difference in acceptance scores between the in-clinic group

and the RPM. Nevertheless, the outcome of patient satisfaction painted an entirely different picture.

Patients who underwent RPM rated the LATITUDE system with a median score of nine out of 10 (IQR: 8–10). Furthermore, 97% would recommend it to other patients, while 87% reported it improved awareness of their own health. Irrespective of this, Meine noted that 53% of patients experienced issues; 64% in the first month, mainly due to installation problems and insecurity about transmission, yet 85% of the issues were solved.

Looking at mortality, hospitalisation and ICD therapy, there was also no differences observed between the two groups. That being said, Meine commented that mortality rates for both groups were very low compared to previous trials.

Lastly, the preliminary results of the estimated cost differences found the total costs in the RPM group to be significantly lower (a reduction of 22%) compared with the non-RPM (in-clinic) group. In concordance with Garcia-Fernández et al’s findings, Meine reported that this was due to less in-office visits in the RPM patients (as 15% less visits occurred compared to the in-clinic patients). However, these cost analyses were only based on the indexed Dutch costing manual.

Meine noted that these preliminary results need to be expanded to other national costing manuals to obtain a clearer picture of RPM cost-effectiveness.

Both Garcia-Fernández and Meine concluded their presentations by reiterating the benefits of RPM. Garcia-Fernández reinforced that RPM in conjunction with remote interrogation (during follow-up) every six months, was not found to be inferior in terms of safety. Furthermore, he noted that this method was able to reduce in-office evaluations without a significant increase in unscheduled visits, while reducing the workload of the staff. Although Meine found that patient-reported health status and ICD acceptance do not differ in patients on RPM and those receiving in-clinic check-ups alone, the findings of the RemoteCIED trial indicated that the majority of patients were highly satisfied with RPM, as well as conveying direct cost benefits of RPM regarding ICD follow up.

The topic of RPM is currently receiving close review; bearing this in mind, Garcia-Fernández stated: “Clinical evidence suggests that remote monitoring could become the gold standard for CIEDs surveillance.”

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Four out of 10 patients with atrial fibrillation have unknown brain damage Four out of 10 patients with atrial fibrillation (AF) but no history of stroke or transient ischaemic attack have previously unknown brain damage, according to the first results of the Swiss Atrial Fibrillation Cohort Study (Swiss-AF) presented at European Society of Cardiology Congress 2018 (ESC; 25–29 August, Munich, Germany).

“O

ur results suggest that clinically unrecognised brain damage may explain the association between dementia and AF in patients without prior stroke,” said co-principal investigator David Conen of McMaster University, Hamilton, Canada.

Patients with AF have a significantly increased risk of stroke and this may be why patients with AF also face an increased risk of cognitive dysfunction and dementia.

However, the relationship between AF and dementia has also been shown among patients without prior strokes, meaning that additional mechanisms have to be involved.

Clarifying the mechanisms by which AF increases the risk of cognitive dysfunction and dementia is a first step towards developing preventive measures.

Swiss-AF is a prospective, observational study designed to pinpoint the mechanisms of cognitive decline in patients with atrial fibrillation. This analysis investigated the prevalence of silent brain damage in AF patients.

The study enrolled 2,415 patients aged over 65 years with AF between 2014 and 2017 from 14 centres in Switzerland. All patients without contraindications underwent standardised brain magnetic resonance imaging and the images were analysed in a central core laboratory. Scans were available in 1,736 patients. Of those, 347 (20%) patients had a history of stroke or transient ischaemic

attack and were excluded from the analysis.

The final analysis included 1,389 patients with AF but no history of stroke or transient ischaemic attack. The average age of participants was 72 years, and 26% were women. The scans showed that 569 (41%) patients had at least one type of previously unknown brain damage: 207 (15%) had a cerebral infarct, 269 (19%) had small bleeds in the brain (microbleeds), and 222 (16%) had small deep brain lesions.

“Four in 10 patients with AF but no history of stroke or transient ischaemic attack had clinically unrecognised ‘silent’ brain lesions,” said Conen. “This brain damage could trigger cognitive decline.”

Most study participants (1,234; 89%) were treated with oral anticoagulants. Co-principal investigator Stefan Osswald of University Hospital Basel, Switzerland, noted that the cross-sectional analysis looked at the data at a single point in time and cannot address the question of whether the cerebral infarcts and other brain lesions occurred before or after initiation of oral anticoagulation. Osswald said, “The findings nevertheless raise the issue that oral anticoagulation might not prevent all brain damage in patients with atrial fibrillation.”

Conen added, “All Swiss-AF participants underwent extensive cognitive testing. These data will be analysed to see whether patients with silent brain lesions also have impaired cognitive function.”

Burnout contributes to the rising rate of suicide among physicians Mental health is a significant concern for physicians. At the European Society of Cardiology Congress (ESC; 25–29 August, Munich, Germany) Anthony DeMaria (University of California, San Diego, La Jolla, USA) co-chaired a special session on the issue.

A

recent report in Medscape highlighted the contributing factors to mental health issues amond physicians. More than half of physicians (56%) who reported burnout cited excess bureaucracy. Other causes are long working hours (39%), lack of respect from colleagues (26%), increasing computerisation of practice (24%), insufficient compensation (24%) and a lack of control/autonomy (21%).

“The independence of physicians is becoming ever more restricted,”

confirms DeMaria. “Mounting rules and regulations—coming from government, payers and hospital organisations—are frustrating. The transition to electronic health records is a classic example of the need for increased documentation, which is certainly a problem in the USA, and I have reason to believe that it is the same in Europe,” he says.

In the USA, there are 400 physician suicides a year; twice the suicide rate of the general American population. Death by suicide is the second leading cause

of death among residents. Fifty-four per cent of doctors say they are burned out; 88% acknowledge they are moderately to severely stressed, and 59% of doctors say they would not recommend a career in medicine to their children.

These statistics are the result of recent research by Tait Shanafelt (Mayo clinic; Stanford Medicine, Stanford, USA) and colleagues, where the investigators surveyed almost 7,000 physicians. The same study reveals that between 2011 and 2014, there was an increase in the percentage of physicians reporting burnout, and a decrease in the number of surgeons who believed they experienced a good work-life balance.

American psychologist Herbert Freudenberger defines burn out, which first appeared in print in a 1974 issue of the Journal of Social Issues, as, “A state of emotional, mental and physical exhaustion caused by excessive and prolonged stress. It is a chronic process of energy expenditure without appropriate periods of recovery.”

Michael Weinstein, a general surgeon at Thomas Jefferson University Hospital,

Philadelphia, USA, wrote a first person account of his struggles with dysthymia, depression and suicidal ideation in the New England Journal of Medicine.

Weinstein wrote: “I endured. I completed residency and fellowship and continued to endure for 16 years. Outside observers might have perceived me as ‘having it all’: a surgeon with leadership promise, with an amazing wife and two great kids, who’s paid more than I ever expected to earn.

“But enduring is not thriving. I had heard of burnout but didn’t really comprehend it. And though I had mental illness, I still saw it as a weakness, a personal fault. I remember early in my career hearing of a colleague who took a leave of absence for a ‘nervous breakdown.’ I joked about it, said he was weak. Now it was my turn.”

DeMaria thinks that looking at the causes of their frustrations is vital. “Assuming that the challenges and sources of stress are not financial, which presumably is readily fixed with more money, then the main issue is workload,” he says. “Cardiologists are frequently called on to handle after-hours emergencies and often impact lifestyle.

What would help enormously is a reduction in the call for documentation, especially as it is often not particularly important.”

The prevalence and nature of burn out has attracted the attention of the medical profession and healthcare enterprise in general, which is a positive step forward. As DeMaria emphasises, “The ESC recognises the importance of burnout for cardiologists and for their membership. They are giving the topic a lot of attention and rightly so.”

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Clinical News CONVERGE IDE clinical trial completes enrolment

Atricure have announced that the enrolment of the full cohort of 153 patients in the CONVERGE IDE clinical trial has been completed.

CONVERGE IDE is the first prospective, randomised study comparing the Convergent approach to endocardial catheter ablation in persistent and long-standing persistent atrial fibrillation (AF) patients.

The Convergent approach is a multidisciplinary therapy in which a closedchest epicardial ablation is performed by a surgeon, and then complemented by an endocardial catheter ablation performed by an electrophysiologist. Patients were enrolled at 25 sites across the USA, along with two sites in the UK. The CONVERGE study’s primary efficacy endpoint is for enrolled patients to be AF, atrial tachycardia, and atrial flutter free, absent class I and III AADs except for a previously failed or intolerant class I or III antiarrhythmic drugs, with no increase in dosage following the three-month blanking period through the 12 months’ post procedure follow-up visit. The last patient follow-up is expected to be sometime in the third quarter of 2019, after which the company will submit final documentation to the US Food and Drug Administration and seek a premarket approval (PMA).

“The CONVERGE trial is an important step forward for the cardiology community in furthering available treatment options for Afib patients,” said David De Lurgio, principal investigator for the trial, and director of electrophysiology at Emory Heart and Vascular Center in Atlanta, USA. “This study is differentiated from other studies currently being conducted on the persistent and long-standing persistent population, because there is no time restriction on the duration of diagnosed AF in the patients being studied. Patients with persistent and long-standing persistent AF make up a very large percentage of the diagnosed population, and the trial is intended to study the safety and effectiveness of the Convergent approach for those patients that have limited other options for effective treatment.”

Medtronic begins pilot study of investigational extravascular ICD system

Medtronic have announced the start of a pilot study of its investigational extravascular implantable cardioverter defibrillator (EV ICD) system, in which a lead is placed outside of the heart and veins to deliver lifesaving defibrillation and antitachycardia pacing therapy all in one system, with a device size similar to transvenous ICDs. The first patient implant was performed at Christchurch Hospital in New Zealand, representing

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the first intended long-term patient use of the Medtronic EV ICD system.

“The Medtronic EV ICD system has the potential to deliver the benefits of traditional ICDs, while eliminating the risks that can occur when leads are implanted inside the veins and heart,” said Ian Crozier, principal investigator in the Medtronic extravascular ICD pilot study at Christchurch Hospital, Christchurch, New Zealand. “We are incredibly pleased to contribute to this important research that will serve as a key step in establishing the safety and efficacy of this new approach.”

The pilot study will assess the Medtronic EV ICD system in 20 patients at four sites: Christchurch Hospital (Ian Crozier); Austin Health in Heidelberg, Australia (PI: David O’Donnell); MonashHeart in Clayton, Australia (PI: Emily Kotschet); and The Prince Charles Hospital in Brisbane, Australia (PI: Haris Haqqani). After implantation of the system, patients and their devices will be routinely checked to assess safety and device performance.

The Medtronic EV ICD system is intended to provide the benefits of traditional transvenous ICDs including lifesaving defibrillation therapy, antitachycardia pacing to painlessly terminate arrhythmias, as well as postshock pacing to protect from sudden cardiac death; and bradycardia pacing to address abnormally slow heart rates. It also is the same size (33cc) and shape, and is expected to have similar longevity as traditional ICDs, but without any leads (thin wires) in the veins or heart.

The investigational EV ICD device is implanted in the left mid-axillary region below the left armpit, and the newly designed lead is placed under the sternum (breastbone). New procedure tools guide the delivery of the system.

Medtronic research teams developed the EV ICD System and have completed multiple early research and acute feasibility studies using the system components, including the ASD (acute sensing and defibrillation), SPACE (substernal pacing acute clinical evaluation) and ASD2 studies.

Clinical trial to evaluate ECG belt for optimising heart failure therapy launches

Medtronic has announced the first enrolments in a new clinical trial evaluating the ECG (electrocardiography) Belt Research System (ECG Belt, Medtronic) as a diagnostic tool for optimising cardiac resynchronisation therapy (CRT) for patients with heart failure. The first patient enrolled in the ECG Belt for CRT Response trial was at Mercy Medical Center, Des Moines, USA, by Troy Hounshell, Iowa Heart Center. The ECG Belt is investigational and not approved for sale in the USA.

ECG Belt for CRT Response is a prospective, randomised, interventional, investigational study that will initially enrol patients in 10 centres across the USA. The trial will compare patients treated with CRT and ECG Belt diagnostics to patients treated with standard CRT. The study will expand to additional sites worldwide to ensure a total of 400 randomised patients.

“The aim of this technology is to give physicians immediate feedback that may impact clinical decision making at the time of implant and also during follow-up visits,” said Hounshell, electrophysiologist at Iowa Heart Center, and the site’s principal investigator in the study. “By pairing CRT with the ECG Belt, we have the potential to provide a more personalised and non-invasive approach to help heart failure patients.”

Using the ECG Belt during the trial, clinicians will assess the heart’s electrical activity through real-time synchronisation measurements. At the time of CRT device implant, the ECG Belt will be applied externally to patients’ bodies, wrapped around the chest and back, to help physicians guide placement of the left ventricular lead.

The ECG Belt will be used again at follow-up visits to further optimise the device’s programmed settings.

Cardioskin launched at European Society of Cardiology meeting

WeHealth, by Servier, has launched Cardioskin—a connected solution that is designed to function as an ambulatory wearable 15-lead ECG—at the 2018 European Society of Cardiology Congress (ESC; 25–29 August, Munich, Germany). A press release reports that Cardioskin is composed of a smart textile (woven into a T-shirt) that aims to measure the electrical activity of the heart from several angles and detect abnormalities in situations that require longer-term cardiac-activity monitoring.

The ECG data can be transmitted in real-time, considerably speeding up the process of diagnosis and clinical decision-making. Through a connected mobile App, the patient can identify when they have symptoms, enabling the cardiologist to correlate such symptoms with the data collected by the T-shirt.

The press release states that sophisticated software integrated into a cloud-based platform allows rapid and efficient analysis of all of the data collected.

By increasing the duration and ease

of more prolonged ECG monitoring, the Cardioskin digital wearable seeks to allow better identification of potentially serious heart abnormalities (including arrhythmia and ischaemia) that may only occur intermittently and be missed by other monitoring techniques. Consequently, the patient can receive better treatments personalised to their condition and will experience a better outcome.

Martin Cowie (Imperial College London, London, UK), who is chair of the newly established ESC Digital Health Committee, comments: “It is fantastic to see a new solution to the very real problem of diagnosing intermittent heart abnormalities that may explain such serious conditions as syncope or stroke.

Using the best of modern wearable digital technology, combined with a mobile App and an intelligent cloudbased platform, Cardioskin will likely prove to be an important tool for the modern cardiologist.”

New cardiac ultrasound solutions with anatomical intelligence launched

Royal Philips has introduced the EPIQ CVx cardiovascular ultrasound system.

Built on the powerful EPIQ ultrasound platform, EPIQ CVx is specifically designed to increase diagnostic confidence and simplify workflow for clinicians, giving them more time to interact with their patients and reducing the need for repeat scans.

The initial response to the new system has been overwhelmingly positive: 95% of a group of clinicians who were shown the new EPIQ CVx believed it offered improved image quality: sharper and clearer images. Philips is also introducing the EPIQ CVxi, specifically tailored for use in the interventional lab. EPIQ CVx and EPIQ CVxi are CE marked and have received 510(k) clearance from the US Food and Drug Administration (FDA).

The EPIQ CVx includes TrueVue, giving clinicians the ability to see photorealistic renderings of the heart, which improves cardiac anatomy analysis by offering detailed tissue and depth perception imaging through a new virtual light source. The system provides cardiologists with high image quality through the latest generation OLED monitor, offering a more dynamic, wider viewing angle for side-by-side image comparison. By combining the new OLED monitor with TrueVue, clinicians can have the confidence to provide exceptional care for all patients, including paediatric patients, whose small hearts can be challenging to image.

The system offers a variety of new features including Dynamic Heart Model. Building on Philips HeartModel, it uses anatomical intelligence to automatically quantify left ventricle function to produce a multi-beat analysis for adult patients. Dynamic Heart Model has been shown to reduce the amount of time to generate a 3D ejection fraction, an important measurement in determining how well the heart is pumping out blood, by 83%.

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Product News PURE EP System receives US FDA clearance

Biotronik is now the exclusive US distributor of MoMe cardiac monitor

Biotronik is now the exclusive US distributor for InfoBionic’s MoMe Kardia external cardiac diagnostic monitor, it has announced in a press release. The device benefits patients suspected of experiencing cardiac arrhythmias and is designed to increase early detection and diagnosis of cardiac arrhythmias by providing physicians with the ability to access near real-time electrocardiographic data.

Monitoring can also uncover patients at higher risk of sudden cardiac death, hospitalisation and life-threatening cardiac events decrease with early diagnosis and treatment.

With automated cloud-based analytics, patient data is immediately available to physicians without the need for costly third-party services. MoMe creates access to information that enables intervention to prevent negative outcomes. Medication compliance can be identified and managed, symptoms can be correlated with rhythms, and triggers of cardiac events can be found by analysing the onset and resolution data of an event.

“MoMe is unique in providing near real-time full disclosure electrocardiographic monitoring,” said Colin Movsowitz, electrophysiologist at Einstein Medical Center Montgomery, Philadelphia, USA. “It replicates a hospital telemetry monitoring centre. MoMe allows clinical decisions to be made on data rather than assumptions. It sets a new standard in providing physicians easy access to ambulatory electrocardiographic data.”

Patients can easily be trained on how to use the one-button monitor. Once the patient is home, physicians can remotely switch the monitor between Holter, Event and Mobile Cardiac Telemetry— lessening the need for office visits and saving time and money for the patient.

From enrolment to diagnosis, physicians have total control of the monitor.

“With MoMe we’ve extended our portfolio of cardiovascular solutions to support physicians in providing the best care possible as early as possible,” said Marlou Janssen, president of Biotronik in the USA. “MoMe provides access to critical data and workflow efficiencies that help physicians identify and prevent cardiac events. It is a critical step in providing comprehensive cardiac care.”

BioSig Technologies have announced that the Company has received 510(k) clearance for its first product, PURE EP System, from the US Food and Drug Administration (FDA).

The non-invasive PURE EP System is a computerised system intended for acquiring, digitising, amplifying, filtering, measuring and calculating, displaying, recording and storing of electrocardiographic and intracardiac signals for patients undergoing electrophysiology (EP) procedures in an EP laboratory. The system is indicated for use under the supervision of licensed healthcare practitioners who are responsible for interpreting the data.

The PURE EP System aims to minimise noise and artifacts, and acquire highfidelity cardiac signals. Improving cardiac signals may potentially increase the diagnostic value of these signals, thereby possibly improving accuracy and efficiency of the EP studies and related procedures.

To date, BioSig has performed 12 pre-clinical studies at Mayo Clinic in Rochester, three at UCLA Medical Center in Los Angeles, and one at Mount Sinai Hospital in New York (all USA). BioSig signed a 10-year collaboration agreement with Mayo Clinic in 2017 that will enable the Company to advance the platform and expand its capabilities into other areas of clinical importance.

Minnetronix, BioSig’s manufacturing partner in St. Paul, USA, has produced initial systems that will allow the Company to enter the market in the USA with selected sites.

“Our PURE EP System is the culmination of many years of scientific research and business development efforts. It is our goal to provide tangible benefits to electrophysiologists and improve the current standards of EP procedures in the clinical setting. We are excited to bring the advanced platform to the US market,” commented Kenneth L Londoner, chairman and CEO of BioSig Technologies.

VisONE system for heart failure implanted for first time

VisCardia has announced the first implant of its VisONE implantable system for heart failure, and the commencement of its VisONE Heart Failure pilot study in Ukraine.

According to a press release, the VisONE implantable system delivers VisCardia’s proprietary asymptomatic diaphragmatic stimulation therapy to improve cardiac function. By electrically stimulating the diaphragm in an asymptomatic manner, transient intrathoracic pressures gaited

to cardiac activity are applied against the cardiac walls, improving both cardiac filling and output.

The implant took place at the Heart Institute, Kyiv, Ukraine, under the leadership of Institute Borys Todurov and principal investigator Vitaliy Demyanchuk. The patient, a 53-year-old male with a reduced ejection fraction of 17%, remained in symptomatic heart failure despite an optimally titrated medical regimen, and had no alternative treatment options.

General surgeon Oleksandr Plehutsa, who performed the laparoscopic implant, comments: “The practicality and expediency of this novel and minimally invasive approach reduces critical anaesthesia times for this delicate heart failure population, enabling a quicker recovery versus established medical device therapies.”

Furthermore, Todurov notes: “We are excited at the potential of this therapy to address a significant gap in clinical care. Our centre will be actively and methodically studying its impact on heart failure.”

Paul Erne (University Hospital of Basel, Basel, Switzerland) states: “During VisONE this 12-month pilot study, we are optimistic VisONE will deliver comparable benefits as those observed during our ADS feasibility studies.”

Echocardiographic data will be analysed at the University Hospital of Zurich under the direction of Felix Tanner, with statistical analysis performed at the Robertson Centre for Biostatistics in Glasgow, UK, under the guidance of John Cleland.

Michael Mirro, VisCardia’s director of medical affairs, comments: “Given the promising evidence to date, it is exciting to see two recognised groups engaged in studying this new therapy with the proper clinical rigor of a multicentre study used by prominent heart centres.”

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HeartWare HVAD system receives US FDA approval

Medtronic has received US Food and Drug Administration (FDA) approval for a less-invasive implant approach of its HVAD System, a left ventricular assist device (LVAD) for patients with advanced heart failure. The HVAD System is the smallest commercially available LVAD, and the only LVAD approved in the US for implant via thoracotomy, a small lateral, surgical incision between the patient’s ribs on the left side of the chest.

LVADs help the heart pump and increase the amount of blood that flows through the body. They are typically implanted via median sternotomy, a surgical procedure in which a vertical incision is made down the middle of the chest, after which the sternum (or breastbone) is divided.

FDA approval for HVAD implantation via thoracotomy is based on data from the LATERAL prospective clinical trial, in which 144 patients, with end-stage heart failure who were eligible for heart transplant, were enrolled at 26 centres in the US and Canada. The primary endpoint of the trial demonstrated noninferiority of the HVAD implanted in patients via thoracotomy, where survival at six months free from disabling stroke or device explant or exchange due to malfunction was achieved in 88.1% of patients. Since the success outcome exceeded the pre-specified performance goal of 77.5%, the trial achieved its primary endpoint (p=0.0012). The key secondary endpoint revealed a significant reduction in total length of hospital stay, from an average of 26.1 days down to 18 days (p<0.001). Overall survival among patients receiving an HVAD via the thoracotomy procedure was 88.8% at one year. Detailed outcomes of the LATERAL trial and its secondary endpoints were presented at The International Society for Heart and Lung Transplantation (ISHLT) 2018 Scientific Sessions.

“We have demonstrated that a thoracotomy is a safe and effective implant technique for the HVAD System, which gives physicians added flexibility in treating a broad range of patients,” said Edwin McGee, Jr., professor and director, Heart Transplant & Ventricular Assist Device Program, Loyola University Medical Center, Maywood, USA, and principal investigator of the LATERAL trial. “Implanting the HVAD via thoracotomy preserves the chest for a subsequent procedure that patients may need, such as a heart transplant. It also has been shown to result in shorter hospital stays.”

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BIBABriefings

ECG innovation aims to improve cardiac monitoring Two companies—Medtronic and WeHealth

by Servier—are exploring innovative ECG approaches to improve cardiac device optimisation and monitoring. Medtronic, for example, have started to enrol patients in a trial evaluating the “ECG Belt”. The belt will be used, according to a press release, to assess the heart’s electrical activity through real-time synchronisation measurements. The press release reports that the belt is wrapped around the patient’s chest and back at the time of an implant of a cardiac resynchronisation therapy (CRT) device and then used to guide placement of the left ventricular lead. The belt is also designed to be used during follow-up visits.

The prospective, randomised, interventional study will compare diagnostics gathered with the ECG Belt and CRT with those with standard CRT. Troy Hounshell (Mercy Medical Center, Des Moines, USA), a principal investigator in the study, comments: “The aim of this technology is to give physicians immediate feedback that may impact clinical decision making at the time of the implant and also during follow-up visits. By pairing CRT with the ECG belt, we have the potential to provide a more personalised and non-invasive approach to heart failure patients.”

Rather than a belt, WeHealth by Servier have developed a “smart textile” that measures electrical activity and can be woven into a T-shirt. Like Medtronic’s belt, the “Cardioskin” system transmits ECG data in real-time. Furthermore, through an app, a patient can identify when they have symptoms—this allows the treating cardiologist to correlate the reported symptoms with the ECG data collected via the T-shirt. The goal is to allow

Less variability with automated system for calculating ejection fraction Data presented at the 2018 American Society of Echocardiography Annual Scientific Session (22–26 June, Nashville, USA) indicate that use of fully automated software (EchoMD Auto EF, Bay Labs) to estimate ejection fraction is associated with less variability than are cardiologists using the Simpson’s biplane method (according to what has been previously reported in the literature).

Richard Bae (Minneapolis Heart

Institute, Minneapolis, USA) and colleagues used the software to calculate ejection fraction in 405 echocardiographic patient studies (representing a wide range of body mass index scores, ejection fraction values, and ultrasound systems).

The software automatically selected optimal apical four-chamber and apical two-chamber digital video clips to calculate ejection fraction. These calculations were then compared historic calculations

with the Simpon’s biplane method.

The observed variability of the calculations with the software was 8.29% vs. 9.2% for Simpson’s biplane method (p=0.002).

Bae comments: “By supporting fast, efficient, and accurate artificial intelligence-assisted echocardiogram analysis, the algorithms allow physicians to focus on putting results into context for the patient, guiding prognosis and course of management.”

better identification of heart abnormalities (including arrhythmias and ischaemias). Martin Cowie (Imperial College London, London, UK), the chair of the new European Association of Cardiology Digital Health Committee, says: “Using the best of modern wearable digital technology, combined with a mobile app and an intelligent cloud-based platform, Cardioskin will likely prove to be an important tool for the modern cardiologist.”

BIBA Briefings BIBA Briefings is a new platform that provides in-depth analysis of the latest market intelligence from BIBA MedTech Insights, which provides consulting and market analysis services to medical professionals and organisations in the medical device industry in Europe and North America. The platform also reviews data and news.

The aim of each report is to give an overview of the key information affecting the medical device industry, enabling those working in the industry to keep abreast of the latest developments and make knowledgeable decisions.

For more information about BIBA Briefings or BIBA MedTech Insights, please contact Elizabeth Sutherst: elizabeth@bibamedical.com

Calendar of events 3–5 October

ISCAT: 12th International Symposium on Catheter Ablation Techniques Paris, France W: www.iscat.net

7–10 October

Heart Rhythm Congress 2018 Birmingham, UK W: www.heartrhythmcongress.org

22–24 October

29–30 November

Rome, Italy

Cartagena, Colombia

W: www.cardiologyconference.cardiologymeeting.com

W: www.lahrs2018.com

26–27 October

4–6 December

27th European Cardiology Conference

37th Annual Echocardiography Symposium

LAHRS: Latin America Heart Rhythm Society

Miami, USA

18th International Symposium on Progress in Clinical Pacing

W: www.MiamiEcho.BaptistHealth.net

Rome, Italy

28–31 October

W: www.progressinclinicalpacing.com

APHRS: Asia Pacific Heart Rhythm Society Scientific Session

IDSS: 14th International Dead Sea Symposium - Innovations and Controversies in Cardiac Arrythmias

5–8 December

Taipei, Taiwan

Tel-Aviv, Israel

W: www.escardio.org

W: www.aphrs2018.tw

W: www.idss-ep.com

17–20 October

EuroEcho-Imaging 2018 Milan, Italy