Breast cancer is the most common female cancer globally, with one woman in eight in the West eventually developing the disease. However improved screening programmes allowing earlier detection and treatment have greatly contributed to the steadily decreasing breast cancer mortality observed from the 1980s on. Although alternative imaging modalities are available, the current gold standard screening tool is mammography. In the majority of EU countries women are invited for screening from the age of 50 until they reach 70. Currently only France extends screening to include women up to 75, though studies are ongoing in several European countries to assess whether a higher cut-off age would lead to a net benefit for older women.
The main limitation of mammography is that the X-rays from different angles can only provide a 2D image of a 3D structure. This leads to false negative results as normal breast tissue can mask tumours. In addition false positive results augment both patient anxiety and hospital workload; the rationale for only screening women from age 50 is that there is a higher rate of false positives in younger women and a much lower incidence of the disease prior to the onset of the menopause. However because randomized, controlled trials have excluded women over 75, there has been a paucity of data concerning the benefits of continuing to screen all older women. One major concern has been that breast cancers that would not pose a threat to women’s health during their lifetime would be diagnosed and aggressively treated. In addition the U.S. Preventive Services Task Force notes that routine exposure to radiation from mammography results in a slightly higher risk of developing breast cancer; this would increase if women were offered screening for possibly an additional 25 years.
Now two recent studies have provided the data that were lacking. The first, a retrospective cohort study carried out in France, compared patient prognosis in women of 75 and older who presented at an oncology center because of a positive mammography result with older women who had been clinically diagnosed. It was found that the former group had improved, disease-free survival rates. The second robust study utilized data from the US National Mammography Database. Over 5.6 million mammograms from 150 facilities in 31 different States over a seven-year period were analysed, with data sorted according to demographics, mammography results and biopsy results. The cancer detection rate and positive predictive values increased with age up to 90, and the recall rate reduced. Surely the jury is no longer out?

Hospital noise is an issue for babies born prematurely who are at high risk when it comes to external influences such as noise. Their systems are underdeveloped and they need as much sleep and rest as possible to recuperate. This is one of the reasons why the Neonatal Unit at the highly specialized Rigshospitalet hospital in Denmark, began cooperating with the noise measurement company SoundEar this year.

Not all sound is noise
Staff at the Neonatal Unit stress that there is a difference between what they call good sound’ and noise. The point being that not all sound is noise, and not all sound should be eliminated. It is important for the development of the newborns that they hear sound such as their parents and siblings talking and singing to them. It is also important that staff can communicate audibly in critical situations, and it is inevitable that some medical equipment, such as respirators, are noisy. What they do want to reduce is unnecessary sound stemming from alarms, furniture, work flow and talk.

Keeping parents in the loop
An important part of the project is to keep parents informed about why the noise meters are installed and not only focus on reducing noise, but also inform them that they should still talk to their newborns and that some medical care routines will result in a certain level of noise. One way of going about this has been to develop a flyer to hand out to new parents in the neonatal intensive care unit (NICU).

Reducing hospital noise through awareness
The aim is to bring down hospital noise levels at the NICU through installing noise meters in all rooms. Half of the noise meters are anonymous white boxes which solely measure and collect noise levels. The other half of the noise meters also have a display with an ear, that lights up green, yellow or red, indicating the current level of noise in the room.
Reduction in noise levels at the NICU is expected to be achieved through different layers of nudging:

• The noise meters with displays should help staff and families become aware of their own noise levels and change their noisy behaviour.
• The software helps staff become aware of when and where noise levels are critical and something should be done differently.
• The software sends out noise reports on a weekly basis via email to key staff members who use these reports as a basis for further discussion about noise at staff meetings.

Changing routines
After having the SoundEar devices hanging in the NICU for a few months, staff was asked to fill out a questionnaire about the perceived hospital noise levels, and whether the SoundEar devices seemed to have changed anything. 14 staff members, primarily nurses, answered the questionnaire and 78.6 percent reported that the SoundEar devices had made them more attentive to noise levels. The same amount reported to have changed some of their behaviour because of the SoundEar devices.
The change that most staff members reported to have made, was to unpack syringes and other types of medical equipment outside of patient rooms, because they had noticed that the ripping of plastic made an unnecessary amount of noise around the children. Others reported lowering their voices and lowering the noise level of alarms as changes they had made after the installation of the SoundEar devices.
Several staff members also reported to have seen an increase in parents’ attention to noise levels, and that they commented on noise to other visitors and siblings, thereby spreading the attention to noise.

Custom-made software
All the noise meters transfer noise measurement data wirelessly to a central computer, where it is accessible to staff through a piece of software, developed specifically for hospital use by SoundEar in cooperation with staff at the NICU.

Jointly creating a noise measurement system
An important part of the project was to create a system that would help reduce hospital noise and become part of the daily routine at hospitals. For SoundEar, this meant focusing on what staff needed and what their everyday work life looked like and adjusting to that.
In the early days of the project, SoundEar viewed the software platform as the main component of the system and something that staff should be able to interact with daily. They should monitor noise levels just as they were used to monitoring the health levels of the newborns.
To make the software as useful as possible, SoundEar conducted several interviews with staff members. Very soon, it became clear that even though nurses viewed reducing hospital noise as important, their focus was on the critical medical care for the newborns and keeping them alive and well. Their time was limited and they would not be able to prioritize time from their busy schedules to consult a piece of software that did not have immediate medical importance for the children.
Instead, they suggested that a few members of the staff should be responsible for driving the hospital noise reduction, checking the software and gathering insights for the rest of the staff to discuss at weekly meetings. Along the way, the procedure evolved into auto-generated noise reports being sent to key staff members to be discussed at staff meetings on a weekly basis.
www.soundear.dk

In spite of a relatively short history, the use of implantable cardioverter defibrillators (ICDs) has been growing by leaps and bounds. For clinicians, an ICD offers a direct means to avoid sudden cardiac death. Other reasons for the popularity of ICDs include advances in technology, above all miniaturization. More recently, new implantation methodologies such as subcutaneous ICD promise a further boost to their use. The working of ICDs are also easy to explain to patients. There is, nevertheless, one major challenge which ICDs have to still address: limitations to battery life.

Primary and secondary prevention
The principle behind an ICD is relatively straightforward, and covers two broad types of prevention: primary and secondary.
Primary prevention, which accounts for the bulk of ICD implants, refers to patients who have not yet suffered life-threatening arrhythmia.
Secondary prevention concerns survivors of cardiac arrest secondary to ventricular fibrillation or sustained tachycardia (together known as a tachyarrhythmia). Although the user group is smaller, secondary prevention makes the strongest case for an ICD.

Differentiating ventricular tachycardia and ventricular fibrillation
After implantation, the ICD continuously monitors cardiac rhythm and detects abnormalities. ICDs are programmed to recognize and differentiate between ventricular tachycardia (VT) and ventricular fibrillation (VF), after which they deliver therapy in the form of a low- or high-energy electric shock or programmable overdrive pacing to restore sinus rhythm – in the case of ventricular tachycardia, to break the tachycardia before it progresses to fibrillation. Overdrive or anti-tachycardia pacing (ATP) is effective only against VT, not ventricular fibrillation.

Defibrillation now almost 70 years old
The first defibrillation of a human heart dates to 1947, when Claude Beck, an American surgeon at Western University in Ohio, sought to revive a 14-year-old boy whose pulse had stopped during wound closure, following cardiothoracic surgery. Cardiac massage was attempted for 45 minutes, but failed to restart the heart. Ventricular fibrillation was confirmed by ECG. Beck saw no other choice but to deliver a single electric shock. This did not work. However, along with intracardiac administration of procaine hydrochloride, a second shock restored sinus rhythm. Beck’s success led to worldwide acceptance of defibrillation. However, his alternating current (AC) device (subsequently commercialised by RAND Development Corporation) was capable of defibrillating only exposed hearts.

Merging defibrillation and cardioversion
On its part, the pioneering of cardioversion (and the coining of this term) is credited to Bernard Lown, a physician at the Peter Bent Brigham Hospital in Boston. Lown merged defibrillation and cardioversion, and coupled these to portability. In 1959, he successfully applied transthoracic AC shock via a defibrillator to a patient with recurrent bouts of ventricular tachycardia (VT), who had failed to respond to intravenous procainamide. This was the first termination of an arrhythmia other than VF.
Two years later, Lown joined a young electrical engineer called Barouh Berkovitz, who had been researching a relatively safer direct current (DC) defibrillator – based on earlier work in the Soviet Union and Czechoslovakia.
Together, Lown and Berkovits pioneered the concept of synchronizing delivery of an electric shock with the QRS complex sensed by ECG, and a monophasic waveform for shock delivery during a rhythm other than VF. Their work led to launch of the first DC cardioverter-defibrillator in patients.

The implantable ICD device: parallel pathways
The Lown-Berkovits effort was confined to external devices. The concept of an implantable, automated cardiac defibrillator dates to work by Michel Mirowski at Israel’s Tel Hashomer Hospital in the mid-1960s. Mirowski moved to the US in 1968, where he joined forces with Morton Mower, a cardiologist at Sinai Hospital in Baltimore. The two tested a prototype automated defibrillator on dogs.
As often happens in science, another researcher had also been approaching the challenge on a parallel path. In 1970, Dr. John Schuder from the University of Missouri successfully tested an implanted cardiac defibrillator, again in a dog. Schuder also developed the low-energy, high voltage, biphasic waveforms which paved the way for current ICD therapy.
The first human ICD, however, was credited to Mirowski and Mower, along with Dr. Stephen Heiman, owner of a medical technology business called Medrac. In 1980, a defibrillator based on their design was implanted in a patient at Johns Hopkins University, followed shortly afterwards by a model incorporating a cardioverter. The ICD obtained approval from the US Food and Drug Administration (FDA) in 1985.

From thoracotomy to transvenous implantation
The first generation of ICDs were implanted via a thoracotomy, using defibrillator patches applied to the pericardium or epicardium, and connected by transvenous and subcutaneous leads to the device, which was contained in a pocket in the abdominal wall.
ICDs have since become smaller and lighter (thicknesses below 13 mm and weights of 70-75 grams). They are typically implanted transvenously with the device placed, like a pacemaker, in the left pectoral region. Defibrillation is achieved via intravascular coil or spring electrodes.

ICDs versus pharmacotherapy
Over the past two decades, clinical trials have demonstrated the benefits of ICDs compared to antiarrhythmic drugs (AADs). Three randomized trials, known as AVID (Antiarrhythmic versus Implantable Devices), the Canadian Implantable Defibrillator (CIDS) study, and Cardiac Arrest Study Hamburg (CASH), were initiated between the late 1980s and early 1990s in the US, Canada and Europe, respectively.
In 2000, a meta-analysis of the three studies was published in European Heart Journal.’ This found that ICDs reduced the relative risk of recurrent sudden cardiac death by 50% and death from any cause by 28%.

Use after myocardial infarction, quality of life issues
Follow-on initiatives looked at other issues. The Multicenter Automatic Defibrillator Implantation Trial (MADDIT) found that ICD benefited patients with reduced left ventricular function after myocardial infarction (MI). In 2005, the Sudden Cardiac Death in Heart Failure trial (SCD-HeFT) established that ICD reduced all-cause death risk in heart failure patients by 23% as compared to a placebo and absolute mortality by 7.2% after five years.
Quality-of-life (QoL) issues have also assisted acceptance of ICDs. In 2009, psychologists and cardiologists at universities in North Carolina and Florida concluded that QoL in ICD patients was at least equal to, or better than, that of AAD users.

Guidelines on ICD use – differences between US and Europe
Professional bodies have established guidelines on the use of ICDs and routinely provide updates. In the US, these originate from the American College of Cardiology, American Heart Association and the Heart Failure Society of America, and in Europe from the European Society of Cardiology.
Although there are many areas of agreement, some differences exist between the US guideline and the European Society of Cardiology. One difference is that in the US guideline, cardiac resynchronization therapy (CRT) is recommended in New York Heart Association (NYHA) class I patients who have LVEF ≤30%, have ischemic heart disease, are in sinus rhythm, and have a left bundle branch block (LBBB) with a QRS duration ≥150 ms. There is no similar recommendation in the European Society of Cardiology document.

The European Society of Cardiology recommendations include patients with QRS duration <120 ms. The US does not recommend CRT for any functional class or ejection fraction with QRS durations <120 ms. ICD and magnetic resonance
The biggest driver of ICD use in recent years, however, may consist of compatibility with magnetic resonance (MR) imaging. Like other metallic objects, ICDs have been contraindicated for MR. This is however set to change, after the first MR-compatible ICD (Medtronic’s Evera SureScan) received FDA approval in September 2016.
The relevance of MR was researched in significant depth by a team at Pittsburgh’s Allegheny General Hospital, led by Dr. Robert Biederman, medical director of its Cardiovascular MRI Center. The study covered patients in three implantable cardiac device case groups, namely cardiovascular, musculoskeletal and neurology.
The findings were conclusive. In 92-100% of cardiac and musculoskeletal, and 88% of neurology cases, MR exam provided value for the final diagnosis. In 18% of neurology cases, the MR exam altered the diagnosis entirely. In the bulk of cases, said Dr. Biederman, the information could not be obtained with cardiac catheterization, echo or nuclear. In addition, patients were saved from a biopsy of the heart muscle, with all its attendant risks.

The launch of leadless, subcutaneous ICDs
Meanwhile, other factors too are driving development of ICDs. One of the biggest shortcomings of ICDs is the need to run an electric lead through blood vessels. These are susceptible to breakages.
In 2012, Boston Scientific received FDA approval for the world’s first leadless, subcutaneous ICD (S-ICD). Rather than leads, the device uses a pulse generator and electrode beneath the skin with a shocking coil implanted under the left arm. A second-generation S-ICD system, branded Emblem, was approved in 2015.
Nevertheless, S-ICDs have drawbacks. Lacking a lead in sufficient contact with the heart, they cannot pace patients out of bad heart rhythms. S-ICDs are also not MR compatible.

The challenge of battery life
Many experts believe that the principal challenge facing ICDs is battery life. According to the Mayo Clinic, batteries in an ICD ‘can last up to seven years.’ It recommends monitoring battery status every 3-6 months during routine checkups, and states when the battery is ‘nearly out of power,’ the old shock generator needs to be ‘replaced with a new one during a minor outpatient procedure.’
Nevertheless, there has recently been some attention about the risk of the latter. In 2014, a research team led by Daniel B. Kramer of Harvard Medical School studied 111,826 patients in the US National Cardiovascular Data Registry (NCDR) who had end-of-battery life ICD generator replacements. They found more than 40% of patients died within five years of ICD generator replacement, and almost 10% within a year. The authors, however, emphasized that atrial fibrillation, heart failure, and left ventricular ejection fraction were independently associated with poorer survival as were noncardiac co-morbidities (chronic lung disease, cerebrovascular disease, diabetes and kidney conditions). What was needed, they concluded, would be a non-ICD control group.
A recent article in the British Medical Journal’ (BMJ) suggests that battery life needs to be extended to 25 years or more to avoid the risks associated with replacement. The author, Dr. John Dean, a cardiologist at Royal Devon and Exeter Hospital in the UK, points out that 1-5% of battery replacements also carry infection risk for patients.

The future: patient needs and superior waveforms
Ultimately, it is patient needs which will drive the next wave in ICD development. While the medical devices industry has focused on device miniaturization, longer battery life is also clearly a priority. Indeed, a 2004 study in Pacing and Clinical Electrophysiology’ found 90% of ICD patients saying they would trade off smaller ICDs for longer-lasting models.
ICD manufacturers are also looking at developing more sophisticated cardioversion/defibrillation waveforms in order to reduce the threshold of defibrillation, and thereby reduce pain and discomfort.

In addition to designing and manufacturing a complete line of diagnostic cardiology and patient monitoring equipment, Mortara Instrument has always been recognized as a leader in the development of algorithms for safe and reliable ECG analysis. Now, Mortara has taken up a new challenge: Alarm Fatigue management.

Due to the increased number of monitored parameters available today and the need to reduce healthcare costs, algorithms must both be more sensitive and prevent more false alarms than in the past. Cardiac Care Units are always so busy that the large number of false alarms generated every day by monitoring systems can become a serious issue for healthcare personnel. This large number of false alarms induces so-called Alarm Fatigue’: in a nutshell, healthcare professionals, tired of wasting time in silencing false alarms, not only lose trust in their monitoring system, but tend to ignore possibly real alarms.

Mortara VERITAS^TM covers a large variety of diagnostic fields: from automatic resting ECG interpretation, to ambulatory Holter monitoring, to real-time algorithms specifically designed for bedside monitors and central stations, largely employed in Coronary Care and Intensive Care Units. Integrated in all Mortara product lines, VERITAS is constantly updated with new features and improved specificity and sensitivity.

Having obtained levels of sensitivity and specificity in line with major manufacturers is not enough to fight Alarm Fatigue. That is why much attention and investment have been devoted to reducing false alarm rates without affecting sensitivity. The updated VERITAS Arrhythmia algorithm defines a new standard in Alarm Fatigue management: up to 60percent less false alarms for lethal arrhythmias when compared to the most common algorithms available on the market, resulting in vast improvement of reliability of the systems on which it is installed.

The new version of VERITAS will be available on the Mortara monitoring line – Surveyor^TM Central, Surveyor S4 telemetry, Surveyor S12 and S19 bedside monitors – starting November 2016*.

For further information, click  here

Mortara, Surveyor^TM and VERITAS^TM are trademarks or registered trademarks of Mortara Instrument, Inc.

*Not available in the U.S.