INTERCEPT Plasma Transfusion Infection Control System FDA Approved

INTERCEPT Plasma INTERCEPT Plasma Transfusion Infection Control System FDA Approved

Cerus Corporation out of Concord, California received FDA approval for its INTERCEPT Blood System for plasma, a product that’s used to prevent infections by treating blood plasma prior to a transfusion. The system relies on using a proprietary molecule to bind to the DNA and RNA of just about everything within the blood plasma sample. This molecule prevents the replication of nucleic acids, effectively deactivating viruses and bacteria that could be present.

The technique works because blood plasma, being empty of living cells, does not require DNA or RNA to be effective for transfusions. Because the system doesn’t target any specific pathogens but instead works on nearly all viruses and bacteria, there is no need for constant monitoring of relevant infections, having access to specialized assays, and having targeted compounds on hand to attack common pathogens. It’s already being used for the current Ebola outbreak and to stockpile plasma gathered from patients that have recovered from the disease.

INTERCEPT pathogen reduction has been used in Europe for over 10 years as a safety option for platelet and plasma components, and more recently was made available in the U.S. under two Investigational Device Exemption (IDE) studies. In the first study, INTERCEPT Blood System processed platelets will be used to reduce the risk of transfusion-transmitted dengue and chikungunya viruses, both of which are responsible for current epidemics in the Caribbean region, includingPuerto Rico, as well as cases reported in the Southern United States. In the second study, the INTERCEPT plasma system is being used to prepare Ebola convalescent plasma for passive immune transfusion therapy of acutely infected patients, providing an additional layer of safety against pathogens that these recovered donors may have been exposed to due recent travel in Africa. Plasma from recovered Ebola virus patients treated with the INTERCEPT process will be used to create a national stockpile for future patients.

Product page: INTERCEPT Plasma…

Press release: FDA APPROVES INTERCEPT BLOOD SYSTEM FOR PLASMA…

#FOAMed Review 25th Edition

Welcome to the twenty-fifth edition of the #FOAMed Review! The idea of the FOAMed review is to give you a digestible selection of reliable content from the online EM/CC world that you can fit into your busy weekly schedule. Each review will include highlights from the highest yield blog, podcast, video and web sources around. Over a year's span we will be sure to include topics from all core EM content areas...even the ones that may not be the coolest. Check out our indexing section #FOAMED REVIEW which allows you to view previous weekly reviews by edition or by selecting from CORD curriculum categories.


Onto the FOAMed. 


AIRWAY DOGMALYSIS [VIDEO]: Rich Levitan's lecture from SMACC GOLD, a must listen for any airway enthusiast, from ICN. 

POCUS FOR NECROTIZING FASCIITIS [BLOG]: Necrotizing Fasciitis scare the *&$# out of us. A POCUS case that shows US can help at the EDE Blog. 

MYTHBUSTING IN CRITICAL CARE [BLOG]: Sepsis, physiology, and ultrasound all thrown into one blog post as John Farkas at Pulm Crit warns us that not all collapsing IVCs (+ hyperkinetic heart) = volume depletion. 

ULTRASOUND GUIDED SUPRACLAVICULAR SUBCLAVIAN VEIN CANNULATION [VIDEO]


More FOAMed. 

CARDIOVASCULAR DISORDERS 

IT IS FAR TO EARLY FOR A REQUIEM FOR UNSTABLE ANGINA [BLOG]: Dr.Smith with an excellent case presentation of unstable angina...even modern day troponins still aren't good enough to rule it out.

HEMATOLOGIC DISORDERS  

THROMBOCYTOPENIA  [BLOG]: EM Docs with a concise ED approach to thrombocytopenia with great pearls on etiology, workup and disposition. 

RESUSCITATION

HOW TO SAVE A LIFE  [VIDEO]: Andrew Tagg discusses neonatal resuscitation know how like a boss. Click here to watch.

DECISION MAKING

WHEN WE ARE THE DIAGNOSTIC TEST  [BLOG]: Iain Beardsell from St. Emlyn's Blog discusses the idea of gestalt in the practice of EM, what we need to know about ourselves  prior to using it and pitfalls to be on the look out for


See you next week.

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MR-CLEAN & the New Golden Age

I, among many others, have been highly skeptical of thrombolytic therapy and its role in the treatment of acute ischemic stroke.  As has been well-documented, a few trials were positive, many were neutral, and a few were stopped early for harm or futility.  To most of us, this indicates a therapy for whom only a small subset of those treated are ideal candidates for benefit, and the margin between benefit and harm is razor thin.

In my previous posts, I’ve sighed wistfully at the hope of The Next Big Thing in stroke treatment – local endovascular therapy, akin to percutaneous coronary intervention.  However, each major endovascular trial published in the New England Journal last year failed to demonstrate benefit.

MR-CLEAN is different.  MR-CLEAN is rather unambiguously positive.  To be zero or minimally disabled?  The endovascular intervention is favored 12% to 6%.  “Functionally independent”, a modified Rankin Scale of 0-2, favors endovascular intervention 33% to 19%.  A number needed to treat of, apparently, ~8 for independence is nothing to scoff at.

But why?  It’s very similar to IMS-3, which was stopped early due to futility.  Patients are about the same age.  The comparator – usual care, typically tPA – is the same.  Median NIHSS is about the same.  The differences are quite subtle.  Patients were randomized earlier in IMS-3 compared with MR-CLEAN, with the implication IMS-3 includes patients whose natural course was superior, whereas MR-CLEAN enrolled "non-responders".  The other difference, and the one you’ll hear by far the most frequently, is that MR-CLEAN utilized modern stent retrievers, rather than such killing machines as the MERCI device.  Newer, as you've always been taught, is better.

But, clearly, there’s something else we simply cannot splice out of these data.  Patients in MR-CLEAN did awful.  Recall NINDS, where a tPA cohort with a median NIHSS of 14 resulted in 39% attaining mRS 0-1.  In IMS-3, intravenous tPA with a median NIHSS 16 resulted in 26% mRS 0-1.  In MR-CLEAN, intravenous tPA with a median NIHSS of 18 resulted in 6% mRS 0-1.  Patients in MR-CLEAN did recanalize at a greater rate than those in IMS-3, 58% vs. 23-44%, owing to the improved performance of modern retrievers.  In a world where definitively opening the vessel, where reperfusion means time=brain, this makes sense.  But, like NINDS, the positive results do not seem so much to result from the intervention, but rather from the control group simply doing unwell.

As the embargo lifts, I’m sure this post is one of a tiny minority wondering if this is fool’s gold.  If you think of p-values like likelihood ratios, as initially intended, the presence of multiple prior neutral evaluations makes the bar for success that much higher in follow-up trials.  These are excellent results, results I’d like to believe in, but the totality of evidence to date requires they be validated.

I wholeheartedly expect they will not.  Prepare for the full onslaught of hype regarding endovascular therapy for stroke.

“A Randomized Trial of Intra-arterial Treatment for Acute Ischemic Stroke”
http://www.nejm.org/doi/full/10.1056/NEJMoa1411587

Magnets Finally Used to Guide Nanoparticles Deep Within Body (VIDEO)

nanomagnetics Magnets Finally Used to Guide Nanoparticles Deep Within Body (VIDEO)Magnetic nanoparticles have been researched extensively over the last few years as vectors for targeted delivery of drugs within the body. While the idea is full of promise, in practice using magnets to guide these particles to locations deep within the body has been difficult since magnets only pull one way and only areas close to the surface were subject to getting high enough concentrations of the nanoparticles. Now researchers from University of Maryland partnered with Weinberg Medical Physics, a Bethesda-based firm, to develop a technique that uses magnets to propel ferromagnetic particles within the interior of the body.

The system uses external magnets placed around the body and facing each other. Short magnetic pulses are used to create momentary magnetic fields that can influence the orientation and motion of the particles. They tested the technique using ferromagnetic nanorods and showed that the magnetic pulses can be used to orient the rods without actually tugging at them and to immediately push them toward the desired location before they snap back to their original spot. While the experiment was conducted in a laboratory, it’s showing considerable promise for clinical applications and studies using animals are the next step in validating this technology.

nl 2014 03654t 0008 Magnets Finally Used to Guide Nanoparticles Deep Within Body (VIDEO)

The research partnership has led to the formation of Iron Focus Medical, a spin-off that plans to push the technology toward commercialization.

Here’s a video showing how the ferromagnetic nanorods are repeatedly pushed towards a target:

 

Study in Nano LettersDynamic Inversion Enables External Magnets To Concentrate Ferromagnetic Rods to a Central Target…

Company page: Iron Focus Medical…

Press release: Pulsing Magnetic Fields Focus Nano-Particles to Deep Targets…

More than just a Trauma Conference (LTC2014) Blog

Last week (9th-12th December) was the 8th Annual London Trauma Conference (#LTC2014) & London Cardiac Arrest Symposium (#LCAS2014) at the Royal Geographical Society Building in London.  I had the privilege to be invited by the organisers to help provide social media coverage by tweeting around the talks and recording podcasts with some of the key speakers.  This is a quick review of what I got to see, what I learned, and why everyone with an interest in trauma, emergency medicine, pre-hospital care, surgery, critical care or resuscitation should go next year.

Along with the main events of the Trauma Conference & Cardiac Arrest Symposium there was a day dedicated to Air-Ambulance and Pre-hospital care, and many other breakaway sessions (see below), each with their own jam-packed timetables.

Breakaways:

  • Trauma research forum
  • Trauma surgery
  • Trauma nursing
  • Remote critical care
  • Core topics in trauma
  • Motorsport medicine
  • Thoracotomy/REBOA masterclass
  • Advanced paramedic masterclass
  • Cardiac Arrest masterclass

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Seeing the timetable for all of these, I began to understand why an extra pair of tweeting thumbs was needed!  The schedule was full to bursting point with thought provoking, innovative talks and masterclasses by expert speakers from around the world.  The hardest part was deciding where to start, where to focus my attention, and who I could convince into an interview in their limited spare time.  Thankfully, the guys from the St.Emlyn’s Blog and Podcast (Iain Beardsell – @docib and Natalie May – @_nmay) were there too. They covered the bulk of the main Trauma Conference, tweeting feverishly and producing great summary podcasts which are well worth a listen herehere, and here. This allowed me the opportunity to attend the breakaway sessions and the Cardiac Arrest Symposium, and to interview some fascinating people.

Those of you that were following on twitter with hashtags #LTC2014 & #LCAS2014 may have seen some of the take home messages from the talks, but for those that didn’t, I’ll briefly summarise the bits I got to see.

The Elderly in Trauma Epidemic (Trauma Research Forum) with Prof. Chris Moran

If you didn’t know it already, the baby boomers are coming!  With the 75+ population set to double by 2027, Prof. Moran discussed how we need better triaging, more appropriate transfers (not sending all to major trauma centres), network guidelines, and trauma-geriatricians if we are to deal with this ‘demographic tidal wave’.

REBOA (Trauma Surgery Breakaway) – Col. Nigel Tai

It’s sexy, it’s getting a lot of attention of late (some from your’s truly if you recall), and it may well have a role in resuscitation of the exanguinating patient; but Col. Tai discussed how it should be used as a bridge to intervention, not to CT scan.

Chest Trauma (Main Trauma Conference) – Mr Doug West

Mr West was kind enough to be interviewed for a podcast which will be available in the coming weeks and discussed this talk on surgical fixation of flail chests, finger thoracostomy, and the potential dangers of chest drains (yes, complications happen, and when they do, they can be bad – always proceed with caution).  Another great take home message from this talk, as well as good advice for life was “don’t get shot in the chest…twice”, as apparently the chest is incredibly difficult to open the second time round…

Airbags & Motorcycles (Motorsport Medicine Breakaway) – Dr Neil Slabbert

As technology improves and becomes more commercially available, airbag suits may well be sported by an ED patient coming to you soon…though more likely they may be preventing a patient from coming to an ED near you soon. The technology is very clever and the suits won’t activate without significant acceleration/deceleration forces, so if you see them deployed, there has been a significant mechanism.

A Quarter of a Century Between, Within, and Over the Hedges of Ireland (Motorsport Medicine Breakaway Keynote) - Dr Fred Macsorley MBE

This was a captivating talk from a man who has seen first hand the effect of the development of organised trauma and pre-hospital care, whilst still having an absolute love for his day job as a GP.  Take home messages from here include how important a job the volunteer doctors are doing at motorsport events by regularly saving lives at the road-side, but also how important it is to enjoy your work and have a strong support network at home; in Fred’s case his wife and kids for whom he is very thankful.

Leathers, Humps & Helmets – on scene medical care (Motorsport Medicine Breakaway) – Dr John Hinds

An entertaining and informative talk on the mechanisms and patterns of injury in motorcycle racing including some red flags for significant injury:

  • Hitting the kurb – it’s a dead stop or a launch pad!
  • Having broken feet with a reduced GCS – even if the helmet is OK, remember that compression forces from below can cause head injury.
  • Beware the boot in the middle of the road – the foot must point backwards to allow this; causing severe limb & pelvis injury even when the limb looks anatomical (as it has twisted back around).
  • The apparently isolated femur fracture – this can signify a pelvic distraction injury; think pelvic binder, especially if reduced GCS

Ultrasound: How does it change remote clinical care? (Remote Critical Care Breakaway) – Dr Stefan Mazur

Covering the many potential uses for point of care ultra sound and it’s application in the remote environment, including focused echocardiography, FAST scanning (yes, there may be a place for it in the prehospital/remote environment), diagnosis of pneumothorax, neuro-imaging and the measurement of ICP using optic sheath measurement, and it’s use for assessment of fracture reduction.  The take home message being that geography shouldn’t dictate the level of care a patient can receive.

The Use of Intra Aortic Adrenaline in Cardiac Arrest (Cardiac Arrest Symposium) – Prof. James Manning

Interesting and certainly discussion provoking talk.  While we may be starting to move away from peripheral IV adrenaline in cardiac arrest, there may be a role for central, arterial adrenaline.  Prof. Manning claims it is far more titratable as the effect is seen within 30 seconds, and the drug is being delivered exactly where you want it to act.  Definite food for thought, and I had the opportunity to discuss this further in a podcast interview (available soon).

Management of Sudden Cardiac Arrest in Hospital (Cardiac Arrest Symposium Keynote Speech) – Dr Paul Frost

One of the highlights of the cardiac arrest symposium for me was this keynote speech on how to best manage the sudden death of a patient in hospital.  Dr Frost provided a step-wise approach to manage this correctly, and he discussed it with me in a podcast interview that will be well worth a listen.  The main take home here is treat this like you would any other difficult procedure in hospital, give it the priority, attention and senior cover it deserves and get it right, every time.

Future Role of the Resus Officer (Cardiac Arrest Symposium) – Mr. Ken Spearpoint

The role of the resus officer is ever increasing, they have roles in resuscitation, prevention, education and research along with many other grey areas. He also discussed the need for more human factors training for members of the cardiac arrest team. You can hear more on this in our podcast interview.

Pre-Hospital ECMO (Cardiac Arrest Symposium) – Dr Lionel Lamault

A mind-boggling and thought provoking talk by Dr. Lamault who told us about a trial system that is currently running in Paris allowing the initiation of ECMO in the prehospital environment, with some incredible pictures of the procedure being performed in various locations around Paris, including Le Louvre Museum!  They are initiating ECMO on patients with refractory cardiac arrest for 30 minutes, can have it connected within 60 minutes, and are reporting a 10% survival rate.

Selective Aortic Arch Perfusion (Cardiac Arrest Symposium – Douglas Chamberlain Lecture) – Prof. James Manning

25 years of research have lead to Prof. Manning developing this technique that may someday have a role in cardiac arrest resuscitation.  It has been referred to on twitter as ‘REBOA, but for cardiac arrest’, with balloon occlusion of the aorta allowing preferential perfusion of the heart and brain with an oxygenated fluid (e.g. blood) that is rapidly infused up the catheter.  As he says, we are entering an age of endovascular resuscitation with procedures such as SAAP, REBOA, and ECMO. The ins and outs of this are definitely best left to our podcast interview however as he explains the theory far more eloquently than I.

The summaries above are just a selection of the relatively small number of talks I was able to attend. I would highly recommend that if any of the above has tipped your interest, that you start looking at your diary for December 8th-11th next year for #LTC2015 and follow the conference on Twitter @LDNtrauma.  Remember to keep a look out for the podcasts as we release them!
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CASO 132 (2ª parte): SÍNCOPE con el esfuerzo; joven de 15 años con FLUTTER AURICULAR.

Preambulo: El SÍNCOPE con el esfuerzo sugiere un origen cardiogénico.

El FLUTTER  AURICULAR es una arritmia relativamente frecuente que no siempre es fácil de identificar. Existen diferentes tipos de Flutter, el más COMÚN es el tipo I, que se produce por un mecanismo de macro-reentrada en la auricula derecha, en sentido de giro antihorario que pasa por el istmo cavotricuspídeo. ECG: ondas F, negativas en cara inferior, a una frecuencia de +/- 300 pm. con una respuesta ventricular, en casos de bloqueo AV 2:1, de +/- 15o pm. Si el sentido de giro es horario las ondas F, serán positivas en cara inferior.

Es una arritmia frecuente en individuos con cardiopatía de base, tal como la HTA, C. Isquémica o Miocardiopatía, pero puede ocurrir espontáneamente en personas con un corazón sin enfermedades. En este caso se trata de un joven de 15 años sin cardiopatía.

CASO 132 (2ª): Varón de 15 años, deportista de competición (atletismo y fútbol), practicando ejercicio presenta mareo con sensación de palpitaciones y desvanecimiento con pérdida de conocimiento. Avisan a Emergencias que documenta taquicardia rítmica de QRS ancho a 260 pm que revierte a ritmo sinusal tras cardioversión eléctrica sincronizada.

Este joven fue atendido en Marzo-2014 por un episodio similar. En aquel momento a su llegada acudió recuperado salvo la persistencia, en reposo, de taquicardia rítmica de QRS estrecho a 132 lpm:http://urgenciasbidasoa.files.wordpress.com/2014/03/caso-132-ecg-1.jpg?w=625&h=463

ECG: parece ritmo sinusal pero no lo es. Se deja en observación monitorizado. Al cabo de unos minutos presenta nuevamente mareo y palpitaciones. ECG: taquicardia rítmica de QRS ancho a 261 lpm, parece una TV ; es un Flutter con conducción 1:1 y QRS aberrado:CASO 132 Preadenosina

Se le administra un bolo de 6 mg de ADENOSINA y posteriormente de 12 mg. El efecto de la Adenosina permite visualizar ondas F de Flutter a  260 x´. Tira de ECG:http://urgenciasbidasoa.files.wordpress.com/2014/03/caso-132-adenosina11.jpg?w=635&h=154

Posteriormente-> ECG similar al inicial, Flutter auricular con bloqueo 2:1, Fc a 138 lpm:http://urgenciasbidasoa.files.wordpress.com/2014/03/caso-132-post-adenosina.jpg?w=627&h=246

Se administra ATENOLOL 25 mg oral. Al cabo de unas horas -> ECG en Ritmo sinusal:http://urgenciasbidasoa.files.wordpress.com/2014/03/caso-132-ecg-3.jpg?w=628&h=472

En aquel momento el paciente fue remitido a la Unidad de Arritmias para valoración. Se le realizó ECOCARDIOGRAMA y PRUEBA de ESFUERZO normales, RM con dudosa zona de captación septal de dudoso origen isquémico -> se solicita TAC coronario que fue normal y quedó pendiente de EEF. Desde Marzo nuestro joven ha estado asintomático.

Tras el nuevo episodio de síncope con el esfuerzo, estando ingresado se realiza ESTUDIO ELECTROFISIOLÓGICO: se introducen catéteres 6, 7 y 8 F por vena femoral derecha y se sitúan en Sc, aurícula y sobre el istmo cavotricuspideo. Con sobreestimulación desde el seno coronario se induce de forma reproducible flutter auricular antihorario. Se reconstruye la aurícula derecha mediante sistema NavX. Se practican ablaciones lineales sobre el istmo durante flutter consiguiendo paso a ritmo sinusal. Se continúan las aplicaciones hasta la desaparición de las señales focales. Posteriormente, se comprueba bloqueo bidireccional del istmo y la imposibilidad de la inducción de flutter auricular.

A día de hoy, tras la ABLACIÓN DEL ISTMO, nuestro joven paciente se encuentra asintomático y se ha reincorporado a su actividad deportiva sin problemas.