Since 2008, NASA has chosen Mortara as its Medical Devices Partner for use in ECG Monitoring at the International Space Station.

In November 2008, NASA selected Mortara Instrument’s H12+^TM high-resolution Holter recorders to travel onboard the Space Shuttle Endeavor STS-126 mission. The H12+ recorders were used to capture ECG data from the astronauts while working aboard the International Space Station (ISS). Data from the recorders were transmitted from the International Space Station to NASA’s Johnson Space Center in Houston, Texas via satellite where it was analyzed by Mortara’s HScribeTM Holter analysis system. 

Mortara had worked closely with NASA Ames Research Center’s engineers (Space Biosciences Division) to ready the H12+ recorders for the additional stress of space travel. Prior to launch, the H12+ recorders were also used for pre-flight scientific studies; reports generated by the HScribe system allowed for the in-space ECG findings to be compared to any pre-flight ECG study results.

The collaboration with NASA did not end with the Space Shuttle Endeavor STS-126 mission; on March 1, 2016, after a record year-long mission spent in space, Expedition 46 Commander Scott Kelly of NASA and Flight Engineers Mikhail Kornienko and Sergey Volkov landed in Kazakhstan. Kelly and Kornienko completed an International Space Station mission as members of expeditions 43, 44, 45 and 46 to collect valuable data on the effect of long duration weightlessness on the human body that will be used to formulate a human mission to Mars. Once again, the Mortara H12+ played a key role in that data collection.
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Breast tomosynthesis exams, Hologic calls the exams 3D MAMMOGRAPHY^TM, have shown to be an advance over digital mammography, with higher cancer detection rates and fewer patient recalls for additional testing.

The new Affirm prone system, which was installed for the first time in Europe earlier last year, is widely considered one of the most significant advance in biopsy technology since the first prone biopsy system was introduced more than 20 years ago. It uses the same proven detector technology as the Hologic Selenia Dimensions breast tomosynthesis system, a top selling breast cancer screening and diagnostic system in the U.S. and in many other countries around the world. With a significantly larger field of view than the MultiCare Platinum system, along with its translucent paddles, the new prone system is designed to deliver exceptional 2D and 3D^TM images and better target lesions found during 3D MAMMOGRAPHY^TM exams, as well as other screening modalities. In addition, the Affirm prone system allows full 360degree Celsius access to the breast to accommodate most lesion locations. Users can go from a standard to lateral needle approach in seconds to accelerate procedures and ensure reaching targeted lesions.

Doctors in Spain report handling complex biopsies that they were only able to see with breast tomosynthesis imaging with the new system
As Doctor Tejerina, a radiologist with the Centro de Patologia de la Mama, Tejerina Foundation, in Madrid, Spain, reports, feedback from the first wave of patients is very positive. ‘We have been suffering to handle complex biopsies of subtle lesions like faint calcifications or distortions that we were only able to see on 3D images,’ Dr. Tejerina says. ‘Older breast biopsy systems are restricted to 2D imaging with a narrow window for targeting the lesions. Often they require multiple X-ray exposures to find and position the suspect tumour for the biopsy needle. With tomosynthesis imaging on the new Affirm prone system, there is a much wider field of view. So the biopsy device can be positioned anywhere in a 360-degree circle, and areas of suspicion seen only with 3D imaging can be easily biopsied.’
Dr. Tejerina also notes that with the previous Hologic biopsy table, the tube head of the biopsy device had to be positioned manually. ‘The new system does this for us automatically, which saves time,’ he says. ‘The software really streamlines our workflow, so the procedure goes faster.’ And he adds, the Affirm Prone table, with its translucent paddles and wider detector, ‘helps us see lesions in the first scout and significantly reduce the number of images needed to get to the lesion.’
The Centro de Patologia de la Mama, Tejerina Foundation has been leading the way in women’s breast health for over 40 years. In 1997, the Centre was first centerein Spain to install a stereotactic guided prone biopsy table. In 2010 the Centre installed a Hologic Selenia Dimensions breast tomosynthesis system, the first site in Spain to use the innovative technology. In 2010 the Centre was also the first site in Spain to combine the Hologic Affirm^TM upright biopsy system with the Hologic tomosynthesis system. The Centre was also one of the first sites in the world to offer prone biopsies on the new Affirm system from Hologic.

Doctors in the Netherlands say Affirm system is fast and comfortable for patients
Dr. Henebiens, a radiologist at Spaarne Gasthuis Hospital in Hoofddorp-the first Affirm prone user in the Netherlands-commented on how fast doctors can do a procedure on the Affirm system and how comfortable the new system is for patients.
‘We make fewer exposures on the new Affirm prone system, compared to the older MultiCare Platinum table,’ she notes. ‘And because the table uses 3D^TM technology, we use fewer steps getting to the target and getting biopsies.’
Dr. Henebiens also likes how easy it was to get up to speed on the table. ‘The learning curve for the new table was very fast. Training was scheduled for two days, but in one day, the staff knew how to use it.’
The Spaarne Gasthuis Hospital staff had completed over 60 procedures on the table in their first 7 months of use.

Doctors in Italy report faster and lower patient dose biopsies with the new system
Doctor Gianfranco Scaperrotta, Chief of the Breast Imaging and Interventional Radiology at Fondazione IRCCS Istituto Nazionale dei Tumori (INT) in Milano, Italy was an early adopter of the Affirm prone system.
‘The Affirm prone system is a quick, effective and easy to use system,’ he says. ‘The image quality is high, comparable to the Hologic Selenia Dimensions digital mammography system. Workflow is quick thanks to a dedicated workstation and the system’s fully integrated C-arm and automated tube-head. Procedures are faster and safer with the new system thanks to the programmed needle parameters and automated calculations such as the display of safety margins and relative distance in real time.’
After 73 procedures on the new system, INT has seen a 20percent reduction in the time needed for performing a biopsy (patient time under compression) and approximately a 50percent drop in the mean glandular patient dose when they compare the new system to the older Hologic system.
The Fondazione IRCCS Istituto Nazionale dei Tumori is the largest oncology site in Lombardia, the most populous region in Italy. The research and cancer treatment site draws patients from throughout Italy.
In sum, doctors at the first three European Affirm prone install sites reported that the new system offers significant benefits to the patient, the doctor and the technologist.
So what’s next from Hologic in 2D and 3D^TM Breast Biopsy after The Affirm^TM Prone system? Hologic will show at ECR an all-integrated breast biopsy system that combines tissue acquisition, real-time imagining, and tissue handling. The new system is designed to work in synergy with imaging guidance systems like the Affirm^TM Prone table and provide actionable real-time information in the procedure room and improve biopsy workflow.

For specific information on what products are available for sale in a particular country, please contact your local Hologic representative or write to iims@hologic.com

The gamma knife is the best known system for radio surgery (RS). It allows non-invasive brain surgery to be performed in one session, with extreme precision. Based on preoperative radiological examinations, such as CT or MR scans and angiography, the gamma knife provides highly accurate irradiation of deep-seated targets in the brain, using a multitude of collimated beams of ionizing radiation with scalpel-like precision.

No surgical incision, no anesthesia
The uniqueness of the gamma knife (and RS surgery in general) is that no surgical incision is required. This serves to minimize risk to adjoining tissue, reduce the risk of surgical complications. It also eliminates the side effects and dangers of general anesthesia, which would be indispensable for the type of medical conditions it is used to target.
A gamma knife typically contains 201 cobalt-60 sources. Each is mounted in a circular array within a shielded system. The device aims gamma rays via a specialized helmet surgically fixed to the patient’s skull to a target point in the brain. The ‘blades’ of the gamma knife are the beams of gamma radiation programmed to target the lesion at the point where they intersect. In a single treatment session, beams of gamma radiation focus precisely on the lesion. Over time, most lesions slowly decrease in size and dissolve. The exposure is brief and only the tissue being treated receives a significant radiation dose, while the surrounding tissue remains unharmed.

Revolution for brain surgery
The gamma knife has revolutionized brain surgery. Over the last three decades, it has changed the landscape of neurosurgery – treating a range of conditions from brain tumours to vascular malformations with an unmatched level of accuracy. The gamma knife enables patients to undergo a non-invasive form of brain surgery without surgical risks, a long hospital stay or subsequent rehabilitation.
The gamma knife was officially named the Leksell gamma knife, after its lead inventor Lars Leksell, who developed the system in 1967 at the Karolinska Institute in Stockholm. Other key team members included Ladislau Steiner, a Romanian-born neurosurgeon and Borje Larsson, a radiobiologist from Sweden’s Uppsala University.

The CyberKnife
1990 saw the launch of another form of radio-surgical system based on linear accelerators. The best known of these is the CyberKnife, invented in the US by John R. Adler, a Stanford University Professor of Neurosurgery and Radiation Oncology. Unlike the gamma knife, the CyberKnife does not use radioisotopes. Instead, it uses a linear accelerator mounted on a moving arm to deliver X-rays, once again, to a very precise area. The CyberKnife does not use a frame to secure the patient. Instead, a computer monitors a patient’s position during treatment, using fluoroscopy. In other words, the CyberKnife allows for tracking a tumour, rather than fixing the patient. As it does away with a frame, its targets go beyond the brain.

Gamma knife and CyberKnife: Indications
Typically, a gamma knife is used to treat cancer that has metastasized to the brain from another part of the body, acoustic neuroma (a slow-growing tumour of the nerve connecting the ear and brain, pituitary tumours and non-cancerous brain tumours. Its application has also been extended to include certain blood vessel malformations, and fistulas, neuralgia and tremors due to Parkinson’s disease.

On its part, the different design of the CyberKnife allows it to also treat a host of other cancers (breast, kidney, liver, lung, pancreas, prostate and certain skin cancers. The CyberKnife is however, generally not used to treat non-cancerous brain tumours such as chordoma and meningioma.

Gamma knife and epilepsy: a European initiative
In recent years, the gamma knife has drawn attention due to its showing ‘some promise’ for treating certain types of epilepsy.
Attention to such possibilities however date back to 1993, when the first gamma knife treatment for temporal lobe epilepsy was performed at the Hopital Timone in Marseille, France. Just over 5 years later, Na Homolce Hospital in Prague followed with a four-year evaluation on the use of gamma knife in 14 mesial temporal lobe epilepsy (MTLE) patients.

Encouraging results from first study
A pioneering study on gamma knife and epilepsy at France’s Hopital Timone was published in 2000. It covered 25 patients with drug-resistant MTLE with 16 followed up for a period of over 24 months. Thirteen (81%) were seizure free, with two improved. The median latent interval from the gamma knife intervention to seizure cessation was 10.5 months (varying from 6 to 21 months), with two patients immediately becoming seizure free. No cases of permanent neurological deficit (except three cases of non-symptomatic visual field deficit), or morbidity, or mortality were observed.
Although the authors concluded that the ‘optimal parameters for treatment’ remain to be defined, as do studies on ‘dose-related efficacy, effectiveness over longer follow-up periods, and neuropsychological effects’, gamma knife interventions could be ‘a reasonable option,’ and its introduction into epilepsy treatment can reduce the invasiveness and morbidity.’

First and second follow ups to French study
The first five-year follow up to the above released its findings from France in 2004. It found a reduction in median seizure frequency, from 6.16 the month before treatment to 0.33 at 2 years after treatment. In two years, as many as 65% of patients (13 of 20) were seizure free. Five patients reported transient depression, headache, nausea, vomiting, and imbalance. There was ‘no permanent neurological deficit reported except nine visual field deficits.’ Finally, no neuropsychological deterioration was observed two years after treatment and the ‘quality of life was significantly better than that before surgery.’
A second follow-up, in 2008, noted that the gamma knife was ‘an effective and safe treatment for mesial temporal lobe epilepsy.’ Results, it found were ‘maintained over time with no additional side effects. Long-term results compare well with those of conventional surgery.’ The findings remained encouraging, with the mean delay for appearance of the first neuroradiological changes at 12 months. However, all patients who had been initially seizure free experienced a relapse of isolated aura or complex partial seizures during the crucial tapering of the antiepileptic drug. Restoration of medication resulted in good control of seizures.

Efforts in the US: focus on caution
In 2009, one of the first major multi-centric US studies on the gamma knife and epilepsy, led by a team from the University of California, San Francisco, reported three-year outcomes using radiosurgery (RS) for unilateral MTLE.
The authors found seizure remission rates comparable with those reported for open surgery. There were also ‘no major safety concerns with high-dose RS compared with low-dose RS.’ However, they called for additional research to determine whether RS ‘may be a treatment option for some patients with mesial temporal lobe epilepsy.’
Caution was again urged the next year when the US research group noted that RS was a promising treatment for intractable MTLE. However, they also observed ‘that the basis of its efficacy is not well understood…’ The researchers, however, minced no words in their observation that ‘Temporal lobe stereotactic radiosurgery resulted in significant seizure reduction in a delayed fashion which appeared to be well-correlated with structural and biochemical alterations observed on neuroimaging. Early detected changes may offer prognostic information for guiding management.’

Growing interest and availability in US
Nevertheless, there is growing interest across the US in using the gamma knife for epilepsy.
Its potential is highlighted (albeit, to varying degrees) by top facilities such as the Mayo Clinic and other leading hospitals like the University of California at San Francisco. On the other side, the University of Pittsburgh Medical Center explicitly specifies the gamma knife for treatment-resistant epilepsy. An active programme of use is also announced by St. Louis Children’s Hospital, for ‘certain epileptogenic lesions,’ corpus callosotomies as well as hypothalamic hamartomas – a benign plume-like malformation that causes a syndrome characterized by treatment-resistant epilepsy.
Some smaller centres in the US are also describing the Gamma Knife as ‘giving patients with epilepsy another option for treatment.’

Europe seemingly lags US
Although France pioneered studies into the use of the gamma knife in epilepsy, interest in Europe still lags that being shown in the US. One reason may also be that other efforts in Europe have been evidently unsuccessful. For example, a four-year study in the late 1990s in the Czech Republic on using the gamma knife in epileptic patients concluded: ‘Radiosurgery with 25, 20, or 18-Gy marginal dose levels did not lead to seizure control in our patient series, although subsequent epilepsy surgery could stop seizures.’ On the other hand, higher doses were associated with the risk of brain edema, intracranial hypertension, and a temporary increase in seizure frequency.

The ROSE study
Both in the US and Europe, the outlook on using Gamma Knife in MTLE is clearly one of cautious optimism.
Trials conducted to date seem to show mixed results, or do not provide researchers enough conviction, as yet.
For the moment, attention remains focused on an ongoing multi-centre trial called ROSE (Radiosurgery or Open Surgery for Epilepsy). The randomized, double blind trial is funded by the US National Institutes of Health, and is being conducted at 13 centres in the US and the prestigious All India Institute of Medical Sciences in New Delhi.

The trial takes up the hypothesis ‘that radiosurgery is as safe and effective as temporal lobectomy in treating patients with seizures arising from the medial temporal lobe.’ It randomizes patients to either technique and is due to compare seizure remission, cognitive outcomes, and cost. The trial will not only measure outcomes (determined during the course of the final year of a 3-year follow-up period). It will also pay attention to interim measures concerning patient safety, quality of life etc., and compare these between the two groups. The eventual aim is to guide physicians to direct patients between traditional and RS techniques matched to patient characteristics.

It is now clear that casualties after the November 2015 terror attacks in Paris were reduced by a superbly conceived and coordinated response.
While 130 people died in the tragedy, another number deserves attention, too. As many as 302 people were wounded, several seriously. They were triaged, treated on site and then shifted to hospital. Of these, two died during transport and another two in the first 10 days after admission. In other words, the casualty rate in the aftermath of terror was less than 1.5%.

by Ashutosh Sheshabalaya and Antonio Bras Monteiro

Plan Blanc – a collaborative blueprint for disaster medicine
Much of the credit for such an achievement goes to France’s ‘Plan Blanc’ (White Plan), created to respond to disasters. In Paris, the White Plan was activated within an hour after the first incident, namely the bomb explosions at the Stade de France. It mobilized some 40 hospitals, 200 operating rooms, 22,000 beds and 100,000 health professionals.
The White Plan is essentially a collaborative blueprint for disaster medicine. Although its conceptual roots go back several decades, November 2015 was the first time it was put to use.
The White Plan effectively places the entire French hospital system on a war footing, with the ability to pool resources on demand. It establishes a lean/quick-response command, control, communication and information system, mobilizing and synchronizing hospital/clinic bed and staff availability to anticipated victim inflows, postponing chronic surgeries and interventions while readying operating rooms, and providing rolling plans for augmenting resources – both human and material. The White Plan also establishes a specialized unit for informing families and communicating with the media.

No surprise about French leadership
According to us, France is among the world’s best prepared countries to deal medically with the aftermath of a terrorist attack. This laurel should be no surprise, given that the concept of ‘disaster medicine’ (médecine de catastrophe) was developed in the 1980s by three French physicians – René Noto, Alain Larcan and Pierre Huguenard. The French Society of Disaster Medicine/Société Française de Médecine de Catastrophe (SFMC) was founded in 1983.

Emergency medicine versus disaster medicine
Both emergency medicine and disaster medicine deal with the kind of challenges seen in Paris: gunshot wounds, blast wounds caused by explosions with organ and tissue damage, contusion and embolisms, multiple penetrations, pulmonary damage, and last but not least, shock.
The key difference between the two, however, involves the subject for medical attention. In emergency medicine, the subject is an individual patient, while disaster medicine deals with a group of patients. Disaster medicine begins on site and, given extreme constraints in human resources and equipment, is devoid of any element of personal medical care. It also uses specialized equipment, such as portable ultrasound and minimalist lightweight stretchers, while first responders are trained to improvise – for instance, carrying patients by their arms and legs. All this was evident in Paris.

Specialized military medical practices
What also was seen in Paris was a full range of specialized techniques. Some of these are derived direct from military medicine – hemorrhage control with tourniquets, hypotensive resuscitation and hypothermia prevention.
Another battlefield practice deployed in Paris (and debated subsequently by clinicians in many other countries) was to let the blood pressure of thoracic primary blast injury victims fall to levels which avoided exsanguination, but not below that required to maintain perfusion.

Anticipating frictions
Although considerable attention was paid to the White Plan, other Plans too rolled into place in the immediate aftermath of the first attack in Paris. Taken together, they highlight how potential conflicts on roles and responsibilities, jurisdiction etc. between different sets of professionals, in a period of extreme personal and systemic stress, had been anticipated, with interdisciplinary protocols already in place to minimize confusion between the police, the fire brigade, ambulance drivers, physicians and other hospital staff as well as the media and the public.
The police, for example, provided perimetric security and crowd control, taking charge of  clearing and organizing pathways to and from incident scenes. The fire brigade was responsible for victim search and extraction as well as certain types of emergency first aid. Though based in principle at field stations, doctors and nurses attended on site as and when required to the severely wounded, conducting triage and handing over patients for transport to ambulance drivers. On their part, specialist Red Cross teams had set up counselling services for victims and their families by midnight – in other words, within just 2-3 hours of the attacks.
The impact of such preparation cannot be under-estimated. In many cases, it allowed BRI special police forces to ignore pleas for help from victims, without disrupting their conscience or composure. Knowing that qualified medical professionals would shortly be taking responsibility for the wounded, the armed intervention teams instead concentrated on their job – to neutralize the terrorists.
All this, it must be underlined, was undertaken in the face of anticipated dislocations due to a strike by thousands of medical professionals protesting a health reform bill in the French Parliament on the very same day as the terrorist attacks. The strike was subsequently called off.

Other plans also implemented
The Alpha Red Plan is designed to deal with extreme emergencies at multiple sites. It sets up an ad-hoc, quick-operational chain of command which pools the full range of emergency services. These include public and private ambulances, the fire brigade and civil protection as well as the Red Cross – to provide evacuation and support. Hospitals outside the region are also placed on standby, if required.
In an interview with the ‘New England Journal of Medicine’, France’s Director-General for Health, Benoit Vallet, said that he had activated emergency protocols in areas outside Paris, including a request for helicopters to be on standby to transport victims. Vallet also noted that military hospitals treated some of the victims: “[Their] surgeons’ experience in war surgery was, unfortunately, exactly what was needed.”
The Red Plan focuses on pre-hospital care in the field. It is based on the principle of extracting and grouping the injured in a field medical facility, triaging them and then providing care on a need basis. Care is based on prioritizing treatment to what is strictly necessary for survival, managing extreme pain and transporting victims without worsening their condition.
Indeed, a key factor behind the success of the Paris response in November was the pre-hospital system. Within an hour of activation of the Red Plan, eight coordinating units dispatched 45 medical teams – each consisting of a doctor, a paramedical assistant and a driver – to six incident sites.

Lessons from France: the US case
The lessons from the French response to terror are being studied in many parts of the world. One of the first questions being asked is whether other countries would have managed as well.

Such a topic seems to be particularly charged in the US, for several reasons.
A key hurdle is that it is not easy to compare the US and French disaster response systems. The US system is built around mainly private hospitals, and is bottom-up and decentralized, while the French system is based largely on public sector hospitals, and is top-down and centralized.
Nevertheless, critics of hospital disaster preparedness in the US complain that decentralization simply means far too many federal initiatives, which leaves considerable scope for confusion about  lines of authority and responsibility in a crisis.

The US National Disaster Medical System
The point organization for overseeing a US federal medical response to disaster is the National Disaster Medical System (NDMS). NDMS is staffed by more than 8,000 civilian volunteer medical personnel. It is tasked with supplementing medical professionals and equipment should local medical resources become overwhelmed. It also has the responsibility to move injured patients to areas unaffected by a disaster.
NDMS was originally under the Department of Health and Human Services (HHS) but was moved as a result of the 9-11 terror attacks to the Federal Emergency Management Agency (FEMA), which is part of the Department of Homeland Security.
After Hurricane Katrina in 2005, amidst allegations of mismanagement, NDMS was removed from FEMA and sent back to HHS, where it now remains parked within the Office of Preparedness and Emergency Operations (OPEO). OPEO is responsible for developing operational plans, analysis and training to respond to public health emergencies and acts of terror.

HHS versus Homeland Security: Turf wars and more
It is evident that there is room for considerable conflict between OPEO and NDMS’s original parent, FEMA. One of the supra-entities tasked with overseeing a disaster response is The National Response Framework, a multi-agency initiative run by FEMA for the Department of Homeland Security.
As Beltway insiders know, the rivalry between Homeland Security and HSS is considerable.

In 2005, a then-confidential report prepared for the Secretary of Homeland Security evaluated US disaster medical readiness. The 103-page report found that “the nation’s medical leadership works in isolation, its medical response capability is fragmented and ill-prepared to deal with a mass casualty event and … HHS lacks an adequate medical support capability for its field operating units.”

NDMS was specifically targeted, as lacking the medical leadership and oversight “to effectively develop, prepare for, employ, and sustain deployable medical assets,” relying on an overtaxed volunteer network and experiencing “critical shortfalls in doctrine, training, logistics support and coordination” with other emergency responders and federal agencies.

ER capacity shortfalls in the US ‘truly alarming’
The impact of such inter-departmental rivalry and the seriousness of the allegations drew the attention of a Congressional Committee a few years later. The Committee chose a very specific target, namely emergency room (ER) capacity in cities considered to be at greatest risk of a terror attack.
Its findings, released in May 2008, were described as “truly alarming”. The hospitals surveyed did not have “sufficient ER capacity to treat a sudden influx of victims from a terrorist bombing.” The situation in Washington DC and Los Angeles were described as being “particularly dire.”
Aside from capacity, the Congressional investigation also revealed what appeared to be “a complete breakdown in communications between the Department of Homeland Security and the Department of Health and Human Services.” When the Committee requested information on hospital emergency surge capacity, “neither department was able to produce a single document.”

In France, some ironies too
There are several lessons to be learned from the French response to the November 13 terror attacks. The most salutary one brims with irony.
The French ‘system’, in the Anglo-Saxon mind, is believed to be statist, bureaucratic, top-heavy and inflexible. The White Plan response in November was based largely on the Parisian APHP, Assistance Publique – Hôpitaux de Paris, Europe’s largest hospital system.
Many critics have questioned the concept of the APHP, particularly its enormous size, as “an obstacle to adaptation in a rapidly changing technological, medical, and social context.” However, the rapid response of the APHP after the Paris terror attacks negates such criticism.
According to APHP Director General Martin Hirsch: “We sensed … that the size of the [APHP] could be an advantage in times of disaster. This advantage has now been demonstrated. No lack of coordination has been identified. No leakage or delay has occurred. No limit was reached.”
“At no time during the emergency was there a shortage of personnel.”

The authors
Ashutosh Sheshabalaya and Antonio Bras Monteiro
SolvX Solutions
Email: office@solvx.com

SolvX provides security and risk consulting services out of offices in Europe, the Middle East and Asia