Final results expected in November 2014.  These could potentially impact atrial fibrillation treatment guidelines, organizers  by providing further clinical evidence regarding the benefits of the cryoablation system in treating a largely underserved patient population. FIRE AND ICE is an independent investigator initiated clinical trial, supported by Medtronic as an External Research Program.

Participants will be followed for an average of one year after initial ablation. The primary endpoint of the trial is the absence of atrial arrhythmias without antiarrhythmic drug therapy and without persistent procedure-related serious adverse events such as strokes, pulmonary vein stenosis and phrenic nerve injury at six and 12 months following ablation.

Professor Karl-Heinz Kuck

Key secondary endpoints that will be assessed include procedural data (total procedure duration, time of fluoroscopy and duration of hospital stay), quality of life, sedation and the need for atrial flutter ablation.

“Through this rigorously designed study, we hope to further validate the long-term treatment benefits associated with cryoballoon ablation,” said Dr Karl-Heinz Kuck, principal investigator and director of cardiology, at Asklepios Klinik St. Georg (Hamburg, Germany). “Given the Arctic Front system’s clinically robust safety and efficacy profile, combined with its straightforward simplicity, this innovative medical technology has the potential to become the standard of care in treating paroxysmal atrial fibrillation”.

Read the article in full here

Dr Andreas Wolff, GPwSI in cardiology

References

1 Wolff AR, Long S, McComb JM, Richley D, Mercer P. The gap between training and provision: a primary-care based ECG survey in North-East England. Br J Cardiol 2012;19:38–40. doi:10.5837/bjc.2012.008

“This study adds to the strength of clinical evidence affirming the effectiveness of pacemakers in reducing the recurrence of asystolic syncope, allowing us to determine which patients may benefit best from pacing,” said Dr Michele Brignole (Ospedali del Tigullio, Lavagna, Italy), the principal investigator of ISSUE-3. “Based on these compelling results, the ISSUE investigators are hopeful that the clinical implications of this study will be taken into account when drafting updates to the current guidelines for these patients”.

While a previous observational study, ISSUE-2, showed that the use of an ICM effectively diagnosed asystolic syncope, thereby leading to effective treatment outcomes, the ISSUE-3 study was needed to confirm these results through a more rigorous, randomised controlled trial, researchers say.

The ISSUE-3 study was sponsored by Medtronic, Inc., conducted in 51 centers in Western Europe and Canada in two phases: a screening phase, followed by a treatment phase. From September 2006 to November 2011, 511 patients met the inclusion criteria and received a device to assist with the diagnosis of each patient’s syncope. Results of the ISSUE-3 include:

• Fainting reoccurred in 185 of the 511 study patients (36%).
• Fainting was documented by the ICM in 141 (76%) of these patients.
• The ICM diagnosed about half (51%) of patients with reoccurring fainting as an asystolic event, indicating them for a pacemaker and making them eligible for the treatment phase of the study. These patients received a dual-chamber pacemaker and were randomised 1:1 (pacemaker on and pacemaker off).

The treatment phase of the study demonstrated significant reduction in recurrence of fainting in patients who received pacemaker therapy. For patients receiving pacemaker implants, the fainting recurrence rate was 25% when the pacemaker was turned on and the fainting recurrence rate was 57% when the pacemaker was turned off (this condition is associated with a drop in blood pressure separate from the asystole).

References

1 Kapoor W. Evaluation and outcome of patients with syncope. Medicine (Baltimore). May 1990;69:160–75.

2 Brignole M, et al. Management of syncope referred urgently to general hospitals with and without syncope units. Europace. 2003;5:293–8.

3 Soteriades ES et al. N Eng J Med. 2002;347(12):878–85.

The BHF launched this award to recognise extraordinary achievements by one of their research fellows. The winner receives a trophy and a grant to further support their work.

Professor Peter Weissberg, BHF Medical Director, said: “The BHF is fighting heart disease through funding high quality research and this is most effectively achieved by supporting the best and brightest people. Nicola Smart is an outstanding role model and we hope this award will inspire other young scientists to follow her lead”.

BHF Medical Director Peter Weissberg presents the award to Dr Smart

Upon receiving the award Dr Nicola Smart said: “I’m honoured to receive this award. The BHF’s support for me and my work over the years has been vital in helping make the progress we have done so far. This award gives me even greater motivation to work towards my ultimate goal of developing a treatment for people who have had heart attacks or suffer from heart failure”.

For more information about the BHF’s research visit bhf.org.uk/science

References

1 For more information about Professor Riley visit: http://www.bhf.org.uk/research/meet-our-researchers/professor-paul-riley.aspx

2 Smart N, Bollini S, Dubé KN, et al. De novo cardiomyocytes from within the activated adult heart after injury. Nature 2011;474:640–4. doi:10.1038/nature10188

Research in reliable systems typically focuses on fail-safe mechanisms that use various redundancy schemes, in which sensitive subsystems are entirely doubled as a fail-safe. Checking for faults in the subsystem increases the energy consumption and decreases the performance of chips, as testing all subsystems cost time and energy.

The DeSyRe consortium takes a different approach, and separates the System-on-Chip (SoC) into two different areas: one which is extremely resistant to faults, and one area with fault-prone processing cores. The cores on the fault-prone area are interchangeable and the task of one core can easily be transferred to any of the other cores in case of a diagnosed malfunction. The fault-free part of the chip is responsible for monitoring the operation of the fault-prone part by performing sanity-checks of the processing cores, and for assuring that each core correctly handles an assigned sub-task.

“It sounds perhaps counterintuitive to design a highly reliable System-on-Chip on the basis of components that may fail, and yet this is exactly what we propose to do. Since our subsystems consist of small, interchangeable processing cores, we can test and exclude individual cores while the function of the whole systems stays intact”, says Gerard Rauwerda, CTO of Recore Systems, one of the industry partners of DeSyRe. “The beauty of the DeSyRe approach is that the system continues to do its job reliably, even if one or more cores fail, extending chip longevity.”

The researchers expect this type of fault-tolerance to reduce energy consumption by at least ten to twenty percent compared to other redundancy schemes, while at the same time minimising penalty on performance.

“People that need implantable medical devices will also benefit from this, as it pays off in a longer battery life and a postponed device replacement without any compromise to reliability,” Ioannis Sourdis concludes.

For the research, 192 stroke survivors (average age 70 years) were asked if they liked or did not like art (music, painting, theatre). Quality of life was compared for patients interested in art (105)  and patients not interested in art (87).

Patients interested in art had better general health, found it easier to walk, and had more energy. They were also happier, less anxious or depressed, and felt calmer. They had better memory and were superior communicators (speaking with other people, understanding what people said, naming people and objects correctly).

Dr Vellone says: “Stroke survivors who saw art as an integrated part of their former lifestyle, by expressing appreciation towards music, painting and theatre, showed better recovery skills than those who did not.”

“In our study the ‘art’ group of patients showed a comparable clinical picture to the ‘no art’ group,” he adds. “This is important because it means that patients belonging to the ‘art’ group had a better quality of life independently from the gravity of stroke. The results suggest that art may make long term changes to the brain which help it recover when things go wrong”.

Other researchers have shown that listening to our favourite music directly stimulates a feeling a pleasure by releasing dopamine in the brain. Dopamine is the starting point of the so-called gratification circuit that activates oxytocin and finally endorphins. “Dopamine improves quality of life each time it is released in the brain,” says Dr Vellone. “Further research is needed to see if other art forms stimulate dopamine release.”

He adds: “These results shed light on the importance of lifelong exposure to art for improving the recovery process after a stroke. Introducing art into nursing care after stroke could help improve stroke survivors’ quality of life.”

References

1 Vellone E, Riegel B, Cocchieri A, et al.  The contribution of caregivers to self-care in heart failure: development of an instrument.  European Journal of Cardiovascular Nursing 2012;11 (Supplement):S8.

Chest radiographs (figure 1) unexpectedly revealed the presence of two right ventricular, one atrial and another (possibly located within the trunk of the main pulmonary artery) pacing lead electrodes. Transthoracic echocardiography and CT contrast enhanced pulmonary angiogram (figure 2a) also confirmed the presence of a retained pacemaker electrode lead within the lumen of the main pulmonary artery. Multiplane and 3D transoesophageal echocardiography (figure 2b) provided additional information of the anatomical relationship between the retained electrodes and surrounding structures and identified echogenic masses (likely thrombi) attached to the atrial side of one of the leads (click to see TOE video clip).

Figure 1. Antero-posterior (a) and lateral (b) chest radiographs showing the multitude of pacemaker electrodes located within the right atrial and ventricular chambers and also within the mid-mediastinum (arrows).

Figure 2-b. Three dimensional transoesophageal echocardiography (mid-oesophageal, 50o view), showing the retained pacemaker electrode (arrows) crossing the RVOT and pulmonary valve (PV) with its tip in contact with the lateral pulmonary artery (PA) wall. There is an echogenic mass (M) within the right atrium attached onto the functionless pacemaker lead. (RA-right atrium, LA-left atrium) (click to see 3D TOE clips).

Figure 2-a. Contrast enhanced CT of the pulmonary arteries in axial view with the main pulmonary trunk at the level of its bifurcation. There is curvilinear blooming artefact (arrow) within the lumen of the vessel consistent with the presence of a retained pacing lead

Figure 3-b. Antero-posterior chest radiograph (in the past), showing the original functionless pacemaker lead (arrow) with its tip secured within the right sub-pectoral area

Figure 3-a. Patient’s upper trunk has a mid-line and left infra-pectoral (with slight skin elevation due to the presence of the generator) well healed scars. There is an additional flat curvilinear right infra-pectoral scar (arrow) consistent with previous pacemaker implantation

Careful physical examination of the patient’s upper chest revealed the presence of a well healed right infra-pectoral scar, thus hinting previous implantation of right-sided pacemaker. Following this finding, a detailed search of our hospital radiographic and medical records helped to solve the conundrum. The patient had a previous right-sided single chamber pacemaker implanted and the generator was later explanted due to malfunction. The retained functionless pacemaker electrode was then capped and secured to the sub-pectoral fascia and a dual chamber pacemaker was implanted contra-laterally. We could speculate that because of traction and following of the direction of blood flow, the retained part of the old pacing lead migrated progressively within the right heart circulatory apparatus thus reaching the main pulmonary artery through the pulmonary valve.

Migration of transvenous pacing electrodes to the pulmonary artery, although rare, is associated with significant morbidity due to concomitant high risk of pulmonary embolisation, infection, arrhythmia or displacement of the functioning pacing leads. It highlights the danger of a common practice of capping and leaving a non-functional pacing lead, in the belief that securing a lead is a safe option.

Conflicts of interest

None declared

Authors

Dr Pandula Athauda-arachchi
(pma29@cantab.net)

Dr Nikolaos Tzemos
(nikotzemos@yahoo.co.uk)

Dr Douglas Elder

Dr Prasad Guntur

Department of Cardiology and Radiology, Ninewells Hospital and Medical School Dundee, DD1 9SY, United Kingdom

Citation

Athauda-arachchi P, Tzemos N, Elder D, Guntur P.  Cardiac imaging conundrum resolved by clinical examination.  BJC Arrhythmia Watch 2012;Issue 23 (Apr)

A recent study from the Gulf Registry of Acute Coronary Events (GRACE), the region’s largest, found that 38% of patients registered were cigarette smokers and 4.4% waterpipe smokers.² The study, which included 6,701 consecutive acute coronary patients in Bahrain, Kuwait, Qatar, Oman, United Arab Emirates, and Yemen, found that the waterpipe smokers were older than the cigarette smokers and more likely to be female.

However, despite the relatively low rate of waterpipe smoking among the patients in this registry study, other studies report more widespread use throughout the region, and especially among the younger age groups. A study from 2004 found that 22% of men in two villages of Egypt reported current or past use of waterpipes, and the habit is increasingly evident even among student communities in the USA, Canada and Germany. The GRACE investigators said: “Although the prevalence of waterpipe smoking in the current registry was low (4.4%), with the current trend of popularity it is expected that physicians and specifically cardiologists across the globe can expect increasing number of their patients with Acute Coronary Syndromes to be waterpipe tobacco smokers.”

They attribute this rising popularity to the introduction of a sweet processed tobacco, the mistaken belief that any harmful effect is less than that of cigarettes, and a dearth of health warnings (as well as a dearth of data). Yet the investigators propose that waterpipe smoking may be associated with greater toxin exposure (because of longer episodes of use as well as more and larger “puffs”, with smoke inhalation as much as 100 times more than from a cigarette). They explain that a single waterpipe episode lasts between 30 and 60 minutes and may involve more than 100 inhalations, each approximately 500 ml in volume (with the smoke passing first through water). “Thus,” they write, “while smoking a single cigarette might produce a total of approximately 500–600 ml of smoke, a single waterpipe use episode might produce about 50,000 ml of smoke.”

“We’re sitting on a time bomb,” says Professor Hani Najm, Vice-President of the Saudi Heart Association. “We will see a lot of heart disease over the next 15 to 20 years. Already, services are saturated. We now have to direct our resources to the primary prevention of risk factors throughout the entire Middle East”.

The explanation for this trend, says Professor Najm, is not just rapid urbanisation and ubiquitous travel by car. There are, in addition, many social and cultural barriers to exercise, especially among women, who find it difficult to find the opportunities and encouragement to take organised exercise.

Professor Najm highlights the efforts of the Association (and many regional health ministries) to develop prevention programmes, and regrets that the smoking policies of many countries – including Saudi Arabia – are not fully enforced. “The basic messages still need to be delivered,” he says. “With such a high prevalence of risk factors in our populations, especially among the young, I still expect rates of cardiovascular disease to increase even further over the next 20 years.”

Details of the ESC’s programme can be found at http://www.escardio.org/congresses/global-activities/saudi-arabia/saudi-heart/Pages/welcome.aspx

Details of the SHA congress can be found at http://www.sha-conferences.com/

References

1. Maziak W. The global epidemic of waterpipe smoking. Addictive Behaviors 2011; 36: 1-5.

2. Al Suwaidi J, Zubaid M, El-Menyar AA, et al. Prevalence and outcome of cigarette and waterpipe smoking among patients with acute coronary syndrome in six Middle-Eastern countries. Eur J Cardiovasc Prevent Rehab 2011; DOI: 10.1177/1741826710393992

3. Maziak W, Ward KD, Soweid RAA, Eissenberg T. Tobacco smoking using a waterpipe: a re-emerging strain in a global epidemic. Tobacco Control 2004; 13: 327–333.

Incremental medical costs to a US health payer of an AF patient experiencing a clinical event during one year following the event were obtained from published literature and inflation adjusted to 2010 cost levels. Medical costs, excluding drug costs, were evaluated and compared for each NOAC vs warfarin. Sensitivity analyses were conducted to determine the influence of variations in clinical event rates and incremental costs on the medical cost reduction.

Per patient year, the total medical cost reduction associated with NOAC use instead of warfarin was estimated to be $439, $62, and $133 for apixaban, dabigatran and rivaroxaban, respectively. For apixaban, cost avoidance was driven by the reduction in major bleeding ($223) and haemorrhagic stroke ($110), with smaller contributions from myocardial infarction ($55) and ischaemic or uncertain type of stroke (IS) ($32); for dabigatran, cost avoidance came from reductions in haemorrhagic stroke ($166) and IS ($97), but with increased costs from MI ($175) and major bleeding ($26). For rivaroxaban, cost avoidance came from haemorrhagic stroke ($92) and MI ($88), but with increased costs from major bleeding ($87).

References

1 Deitelzweig S, Amin A, Jing Y, Makenbaeva D, Wiederkehr D, Lin J, Graham J.  Medical cost reductions associated with the usage of novel oral anticoagulants vs warfarin among atrial fibrillation patients, based on the RE-LY, ROCKET-AF, and ARISTOTLE trials. Journal of Medical Economics 2012;Print: Pages 1–10. doi:10.3111/13696998.2012.680555

Gilead spokesperson Nathan Kaiser told BJC Arrhythmia Watch: “Initiation of this proof-of-concept study is an important milestone as Gilead seeks to develop a fixed-dose combination (FDC) of ranolazine and low dose dronedarone for paroxysmal/persistent (non-permanent) AF”.

“Preclinical data published in the Journal of the American College of Cardiology in 2010 suggest the combination of ranolazine and dronedarone has synergistic effects, with greater suppression of AF than either of the two therapies alone”.

“Based on preclinical data and Phase 1 studies conducted to date, Gilead believes a ranolazine-dronedarone FDC has the potential to be safer and more efficacious than dronedarone used alone at a higher dose, providing a much needed alternative therapy for people living with non-permanent AF”.

References

1 Clinicaltrials.gov (http://www.clinicaltrials.gov/ct2/show/NCT01522651?term=ranolazine+and+dronedarone&rank=1)