Monday, August 30, 2010

Cryospray Against Airway Tumors Leads to Unexpected Complications

Spray cryotherapy with liquid nitrogen has been used effectively for ablating esophageal tumors. Some facilities even perform the technique in an outpatient setting under sedation. However, spray cryotherapy for treating advanced airway lesions—when other treatment options are limited—is more recent, and few reports of its effectiveness have been published (J Thorac Cardiovasc Surg 2010;139:781-782).

To assess their efforts to date, thoracic anesthesiologists at Memorial Sloan-Kettering Cancer Center in New York City reviewed 24 spray cryotherapy procedures in 22 patients; all treatments involved airway-obstructing tumors. Ten of the patients (45%) experienced unexpected and serious respiratory or cardiovascular events; of these, three required reintubation and mechanical ventilation overnight. One patient suffered cardiac arrest and died in the operating room (Table).

Table. Complications From Cryospray
ComplicationN=30
(% of procedures)
Pneumothorax2 (2.8)
Hypoxemia5 (20.8)
Reintubation3 (12.5)
ST-segment changes3 (12.5)
Bradycardia6 (25)
Tachycardia3 (12.5)
Hypotension7 (29)
Death1 (0.04)

“We did not expect to see such an incidence of cardiac complications during this procedure,” said Alessia Pedoto, MD, lead author of the study presented at the 2010 annual meeting of the Society of Cardiovascular Anesthesiologists (abstract SCA41), in New Orleans.

The spray cryotherapy technique delivered liquid nitrogen by catheter through an endoscope at 2 to 4 psi at –196 C, causing rapid freezing and thawing of tissue—resulting in cell death and hemostasis (Figures 1 and 2). A minimum of three cycles of five seconds each was administered to each patient, with a complete visual thaw between each cycle. All patients underwent general anesthesia for combined rigid and flexible bronchoscopy.

Among the 24 procedures, hypoxemia developed in five (20.8%); ST-segment changes developed in three (12.5%); bradycardia in six (25%); and hypotension in seven (29%). More than one complication occurred per procedure.

“Bleeding and pneumothorax have been reported in very small series and we had two cases of pneumothorax we thought were related to the use of jet ventilation with cryospray,” Dr. Pedoto told Anesthesiology News. “We speculate that the use of cold liquid nitrogen is associated with an increase in airway pressure when the spray is used, affecting the heart and the conduction system,” she said.

According to the researchers, spray cryotherapy is a novel technique that can be used to re-establish airway patency in patients with symptomatic airway tumors. The advantages it might offer over airway laser therapy include no fire hazard and improved hemostasis. They said that further study is needed for better selection and improved safety of patients.

QuikClot goes Japanese

WALLINGFORD, Conn.--(BUSINESS WIRE)--Z-Medica Corporation, a medical device company developing innovative hemostatic agents, today announced that it has signed an exclusive distribution agreement with Nihon-Kohden, Japan's leading manufacturer, developer and distributor of medical electronic equipment . The agreement allows Nihon-Kohden the exclusive right to distribute Z-Medica’s QuikClot line of hemostatic agents to hospital, military and law enforcement markets throughout Japan. The companies have been working together since early 2009 to obtain regulatory approval. Such approval for the sale of Z-Medica’s full line of QuikClot hemostatic gauze products was approved by the Japanese Ministry of Health, Labor and Welfare in March 2010.
“We are very pleased that we have signed this distribution agreement with Nihon-Kohden because of their longstanding positive reputation and vast reach throughout the Japanese market,” said Brian Herrman, Chief Executive Officer, Z-Medica. “We believe that clinical practitioners outside of the US will find QuikClot to be a useful tool in achieving hemostasis in a fast, safe and convenient manner, and we intend to continue expanding our international distribution through best-of-breed partners such as Nihon-Kohden.”
QuikClot is a surgical gauze impregnated with kaolin, an inert material with no known contraindications, and can achieve hemostasis in severe bleeding situations in as little as three minutes. QuikClot is widely used throughout several clinical specialties, including cardiology, interventional radiology, critical care, dermatology, emergency medicine, orthopedics and OB/Gyn, and after months of testing against 12 other hemostatic products in the marketplace, the military version of the kaolin gauze (“Combat Gauze”) was chosen as the exclusive product for use by all US Military Forces in 2008. It continues to be the exclusive product used by all USA military forces for first line treatment of bleeding hemorrhage.
“We are very pleased to have this opportunity to market in Japan QuikClot which helps many patients who suffer from bleeding,” said Hiroshi Aida, General Manager of Import Business Operation, Nihon Kohden. “QuikClot also helps medical professionals with much shorter time for achieving hemostasis. It is a nice addition for our product portfolio.”
Z-Medica and Nihon-Kohden have been working together since early 2009 in order to gain the recently granted regulatory approval. The QuikClot line of products to be distributed by Nihon-Kohden in Japan include:
QuikClot Combat Gauze is a soft, white, sterile, nonwoven 3” by 12 feet rolled or z-folded gauze impregnated with kaolin. Each roll of QuikClot Combat Gauze is individually wrapped in an easy rip, military grade foil pouch. Indicated for temporary external control of traumatic bleeding, QuikClot Combat Gauze is flexible and pliable and contours to all wounds. Recommended as the number one hemostatic agent by the COTCCC (Committee on Tactical Combat Casualty Care Committee), QuikClot Combat Gauze is the only product carried by all branches of the US Military to control life-threatening hemorrhage.
QuikClot Emergency Dressing is an easy-to-use dressing which can achieve hemostasis in as little as three minutes, helping to prevent loss of life and limb. Because QuikClot requires very little training to administer, it can be effectively used by medical personnel, civilian first-responders and medical professionals in the field and in clinical environments. This dressing comes in various sizes, including a 4-ply 4” by 4” (10cm x 10cm) and a 6-ply 2”x2” (5cm x 5cm) format.
QuikClot Interventional Hemostatic Bandage consists of a soft, white, double sterile, hydrophilic pad impregnated with kaolin. It is double-wrapped in a blister package and foil pouch for aseptic technique. QuikClot Interventional Hemostatic Bandage is applied topically as an adjunct to manual compression and is indicated for the local management and control of external bleeding from vascular access sites and percutantous catheters or tubes utilizing sheaths up to 12 Fr.
QuikClot Trauma Pad consists of a soft, white, double sterile, three-ply 12”x12” (30cm x 30cm) pad impregnated with kaolin. It is double-wrapped in a peelable foil package for aseptic technique. QuikClot Trauma Pad is indicated for temporary external use to control traumatic bleeding and is also x-ray detectable to ensure proper removal.

About Z-Medica

Z-Medica Corporation is a medical device company developing innovative hemostatic agents. The company manufactures and markets its QuikClot® family of products for hemostasis for use by healthcare professionals, first responders, law enforcement officers and the military. QuikClot products rapidly enhance the body’s natural coagulation process, helping to achieve hemostasis faster. Z-Medica’s QuikClot® Combat Gauze™ product was chosen by the Committee on Tactical Combat Casualty Care (TCCC) as the United States Military’s sole source supplier for first-line hemostatic treatment, based on tests conducted by the Naval Medical Research Center and the U.S. Army Institute for Surgical Research. It continues to be the exclusive product used by all USA military forces for first line treatment of bleeding hemorrhage. QuikClot® products are also widely used by first responders, in hospital emergency rooms, interventional cardiology and radiology laboratories and other healthcare environments where bleeding requires fast and effective control. Z-Medica, named one of the Top 100 Technology “Companies to Watch” in 2008 by the Connecticut Technology Council, is a privately-held company based in Wallingford, CT. More information about Z-Medica Corporation is available at www.z-medica.com.

About Nihon Kohden

Nihon Kohden is Japan’s leading manufacturer, developer and distributor of patient monitors, defibrillators, ECGs, EEGs, EP/EMGs, hematology analyzers and other medical electronic equipment, with subsidiaries in the United States, Europe, and Asia, and distributors in nearly every country in the world. Nihon Kohden is a publicly held company listed in the First Section of the Tokyo Stock Exchange. In addition to designing medical equipment for hospital and clinic use, Nihon Kohden actively contributes to the advance of medical technology.

Sunday, August 29, 2010

FDA rules CollPlant wound dressing a device

The US Food and Drug Administration (FDA) has ruled that the CollPlant Holdings Ltd's (TASE: CLPT) wound dressing product, Vergenix, will undergo the certification process by the Center for Devices and Radiological Health (CDRH), which oversees medical devices.
Vergenix Wound Dressing is wound care sheet composed of pure recombinant human collagen scaffold that provides a moist wound healing environment. The product, a type I collagen, is produced by transgenic tobacco plants. It is designed to treat acute and chronic wounds, such as pressure ulcers, venous ulcers, diabetic ulcers, surgical wounds, abrasions, and second-degree burns.
US licensing procedures for medical devices are shorter than the procedure for pharmaceuticals. CollPlant believes that while Vergenix is based on human recombinant collagen produced through advanced biotechnological techniques, the FDA decision that the CDRH will review the product is very important for the company, as the regulatory procedures are significantly simpler, shorter, and cheaper than for biological and pharmaceutical products. This is a breakthrough since Vergenix will be a pioneering product for CollPlant's subsequent products.
CollPlant's share price rose 9.9% by mid-afternoon to NIS 1.20, giving a market cap of NIS 126 million.
Published by Globes [online], Israel business news - www.globes-online.com - on August 29, 2010

Saturday, August 28, 2010

US Military faces challenges from Chinese Knock-offs

As anyone who has served in combat knows, if a buddy is wounded, the first two things you need to do are make sure he can breathe and his bleeding is stopped.
For the past several years, troops serving in Afghanistan and Iraq have used an advanced Combat-Application-Tourniquet (C-A-T) developed by Composite Resources in Rock Hill, S.C. The tourniquet features a nylon strap and a plastic rod to tighten the strap to stop bleeding.
The regulation C-A-T costs about $28. But about two years ago the Army detected cheap knock offs made by a Hong Kong company that had entered the military's supply chain in Afghanistan and Iraq. The imitation sold for about $8.50.
They're accurate looking fakes, right down to the label and national stock number.
But as Col. John Kragh, a doctor at the U.S. Army Institute of Surgical Research at Fort Sam Houston, pointed out in June, the rod on the fake tourniquet "is bendable to a point where it cannot work right. It's like bending Gumby's arm."
He said the fake tourniquet could be fatal because it cannot stop bleeding. Kragh added a decentralized ordering system probably accounts for the presence of the fake tourniquets in the field, with low-level supply personnel ordering the knock offs over the Internet based on price.
The Defense Department issued a warning about the knock-offs in April, Kragh said, and the Food and Drug Administration this month put out a safety alert about the tourniquets, which are also used by civilian first responders.
The lesson here is a good deal isn't always that; it can even be deadly.

Poll Result - Which Geographical Manufacturing Area for Hemostatic Devices Causes Concern?

Controversies

2007 Chinese Export Recall


The 2007 Chinese export recalls were a series of scandals involving tainted food and products exported from China, starting with tainted pet food imported from China to the United States that poisoned pets. The recalls sparked international concern that many products made in China do not meet minimum quality standards. Soon after, the US halted imports of seafood from China after tests detected the presence of drugs unapproved in the US.China has gone on record to admit that nearly a fifth of products made in China do not reach minimum standards. Also, some children's toys made in China were found to contain excessive levels of lead, prompting widespread concern. In 2006, shipments of cough syrup and other medicines, imported from China to Panama and laden with the toxin diethylene glycol, caused mass poisonings and killed 83 people.
On December 19, 2007, The US House of Representatives passed legislation (H.R. 4040) that would significantly amend the current U.S. safety establishment for consumer products imported from China.

2008 Chinese heparin and milk scandals

In March 2008, major recalls of heparin were announced by the U.S. Food and Drug Administration (FDA) due to contamination of the raw heparin stock imported from China.
The raw material for the recalled heparin batches was processed in China from pig's intestines by the American pharmaceutical firm Scientific Protein Laboratories. The U.S. Food and Drug Administration was quoted as stating that at least 81 deaths were believed linked to a raw heparin ingredient imported from the People's Republic of China, and that they had also received 785 reports of serious injuries associated with the drug’s use. According to the New York Times, "Problems with heparin reported to the agency include difficulty breathing, nausea, vomiting, excessive sweating and rapidly falling blood pressure that in some cases led to life-threatening shock."
Upon investigation of these adverse events by the FDA, academic institutions, and the involved pharmaceutical companies, the contaminant was identified as an "over-sulphated" derivative of chondroitin sulfate, a popular shellfish-derived supplement often used as a treatment forarthritis. Since over-sulphated chondroitin is not a naturally occurring molecule, costs a fraction of true heparin starting material, and mimics the in-vitro properties of heparin, the counterfeit was almost certainly intentional as opposed to an accidental lapse in manufacturing. The raw heparin batches were found to have been cut from 2-60% with the counterfeit substance, and motivation for the adulteration was attributed to a combination of cost effectiveness and a shortage of suitable pigs in China.
When the FDA conducted an inspection of Baxter's Chinese Heparin supplier, it found serious deficiencies at the facility which the FDA detailed in a warning letter.
The FDA has stated that it does not have the funds nor bear the responsibility to inspect on a regular basis overseas manufacturers of active pharmaceutical ingredients such as heparin.
In November 2008, the FDA seized eleven lots of heparin from Celsus Laboratories Inc., a manufacturer in Cincinnati, Ohio.


One year later, the 2008 Chinese milk scandal refers to a food safety incident in mainland People's Republic of China involving milk and infant formula which had been adulterated with melamine, an organic base combined with formaldehyde to form plastic. The result was catastrophic - By 22 September, nearly 53,000 illnesses, over 12,800 hospitalizations, and four infant deaths had been reported, caused by kidney stones and other renal failure.The chemical appeared to have been added to milk in order to cause it to appear to have a higher protein content. The same chemical was also involved in a series of pet food recalls in 2007. In November 2009, two individuals were executed for endangering public safety and producing and selling toxic food.

2009 Made in India scandal

In June 2009, the Nigerian Government Drug Regulatory Authority (NAFDAC) reported about the detention of a large consignment of fake anti-malarial generic pharmaceuticals labeled Made in India but produced in China. The Laboratory analysis conducted by NAFDAC revealed the drugs to be fake and had it not been intercepted, about 64,200 adults would have been affected. The consignment containing Maloxine and Amalar tablets, used for the treatment of Malaria, were valued at 32.1 million Naira and were produced, packed and shipped from China. After Indian Authorities took up the matter, The State Food and Drug Administration (SFDA) of China was asked to investigate the matter[10]. In December 2009, 6 chinese traders were sentenced to death for their involvement.
In July 2009, customs officials in the South Indian port city of Chennai seized spurious cosmetics and mobile phone batteries worth Rs. 30 million, imported into India from Scheko in China. The 40 foot container was held up at the port for more than 75 days and opened on 13th July when the importer did not file a bill of entry. It was reported to contain over 187,000 batteries with Nokia holograms and stickers, and 126,000 cosmetic items including face packs, lipsticks and hair gels
.

Prepare your Hemostat's - Here Come the Anti-Coagulants

Aug 24 (Reuters) - Rival drugmakers are racing to develop
new oral anticoagulants to replace difficult-to-use warfarin for
the prevention of stroke in patients with atrial fibrillation, a
common irregular heart rhythm.
Industry analysts estimate the market will be worth well
over $10 billion in annual sales, making so-called Factor Xa and
direct thrombin inhibitors among the most valuable and closely
watch new drugs in development.
Medical experts and investors will focus on clinical trial
results for two of them -- Bayer (BAYGn.DE) and Johnson &
Johnson's (JNJ.N) Xarelto, and Bristol-Myers Squibb (BMY.N) and
Pfizer's (PFE.N) apixaban -- during the European Society of
Cardiology congress in Stockholm next week.
The table below shows a selection new oral anticoagulants in
development. Pradaxa and Xarelto have already been approved for
use in Europe and some other markets to prevent thrombosis after
surgery, but not yet for stroke prevention:

DRUG COMPANY MECHANISM STATUS

Pradaxa Boehringer Direct thrombin launched EU
Xarelto Bayer/J&J Factor Xa launched EU
apixaban Bristol/Pfizer Factor Xa Phase III
edoxaban Daiichi Factor Xa Phase III
YM150 Astellas Factor Xa Phase III
otamixaban Sanofi Factor Xa Phase III
betrixaban Merck Factor Xa Phase II
letaxaban Takeda Factor Xa Phase II
Source: Thomson Reuters

Wednesday, August 25, 2010

FibroGen - Recombinant Human Type III Collagen

SAN FRANCISCO--(BUSINESS WIRE)--FibroGen, Inc., today announced results of a 2-year clinical study demonstrating that surgical implantation of biosynthetic corneas formulated with the company’s proprietary recombinant human type III collagen (rhCIII) restored vision and promoted nerve regeneration (restoring sensitivity) in patients who had corneal damage and significant vision loss. The results of this phase 1, investigator-sponsored study were published today in Science Translational Medicine.1
“These clinical results suggest that our collagen could potentially provide an important option for patients by reducing risk of disease transmission and increasing supply of corneal implant material in the face of the worldwide shortage of human donor corneas”
Corneal damage and disease are major causes of blindness worldwide. In countries where tissue banking is available, such as the US, treatment is by implantation of human donor corneas. However, there is a severe shortage of human donor tissue worldwide. Patients who do receive donor human corneas, however, can still suffer complications, such as tissue rejection. Corneal prostheses, made from synthetic plastics are used in limited cases, but only where human donor grafts are contraindicated or have been repeatedly unsuccessful. These synthetic alternatives are not designed to replace donor tissues or promote tissue regeneration.
FibroGen pioneered the development of recombinant collagen production technology and is the only producer of rhCIII. Since 2005, FibroGen has collaborated with Dr. May Griffith of Linköping University, senior author of today’s publication, to develop biosynthetic corneas molded from chemically cross-linked rhCIII. The biosynthetic implants are designed to mimic the human cornea, which is composed mainly of the protein collagen.
“Recombinant human collagen is a viable replacement for naturally occurring human collagen that does not have the limitations of human donor tissue or animal-sourced collagens, such as risk of disease transmission and availability of donor supply,” said Dr. Griffith. “Our study provides proof-of-concept that corneal implants composed of recombinant human collagen can promote tissue regrowth and restore vision.”
“These clinical results suggest that our collagen could potentially provide an important option for patients by reducing risk of disease transmission and increasing supply of corneal implant material in the face of the worldwide shortage of human donor corneas,” said Thomas B. Neff, Chief Executive Officer of FibroGen. “This product concept continues to be improved and additional studies are planned.”
About the Phase 1 Study

In the clinical study, 10 patients with corneal disease underwent resection, followed by surgical implantation with rhCIII-based biosynthetic corneas. Two-year post-surgery results demonstrated that 100% of the transplanted corneas remain viable at two years, cells from the patients’ own corneas had grown into the implant, and nerves that had been severed during surgery regrew. In addition, the blink reflex and tear film were restored. In terms of visual acuity, at 24 months, best spectacle-corrected visual acuity improved in six patients, remained unchanged in two patients and decreased in two. None of the patients experienced any rejection reaction or required long-term immunosuppressive therapy, serious issues associated with the use of human donor tissue.
Unmet medical need for a biosynthetic corneal implant

Loss of vision due to corneal disease or trauma affects over 10 million individuals worldwide, but lack of access to good quality donor tissue severely limits the number of transplant procedures that can be done, particularly in the developing world. In the US, an estimated 42,000 corneal grafts are performed annually using optical tissue from cadavers; however, graft rejection can occur, and failure rates are significant. In addition, the mandatory use of steroids with cadaver-sourced corneal material limits their successful use to certain patient populations. Fully synthetic prostheses (without biological activity) have been developed, but their use has been limited to cases where human donor tissue fails repeatedly or cannot be used. Moreover, apart from the US, in most countries, tissue donation and banking systems do not exist.
About FibroGen’s recombinant human collagens

FibroGen is the only producer of highly purified, fully characterized recombinant human type III collagen (rhCIII) intended to replace similar animal- or human-derived materials currently used in a variety of medical, pharmaceutical, and consumer applications. FibroGen uses proprietary recombinant methodology in a yeast expression system with human DNA sequences to develop synthetic versions of human collagens essentially identical to the native protein. Mixtures of various collagen types found in animal-sourced collagen are nearly impossible to segregate. FibroGen has been able to produce specific types of recombinant human collagen (e.g., types I or III) consistently and reproducibly. FibroGen has developed simple, scalable purification processes that provide highly purified and reproducible lots of protein in any desired quantity, and employs a series of rigorous analytical tests to ensure lot-to-lot consistency and high quality.

Tuesday, August 24, 2010

Facts about blood needs in the U.S.

  • Every two seconds someone in the U.S. needs blood.
  • More than 38,000 blood donations are needed every day.
  • A total of 30 million blood components are transfused each year in the U.S. (2006).
  • The average red blood cell transfusion is approximately 3 pints.h
  • The blood type most often requested by hospitals is Type O.
  • The blood used in an emergency is already on the shelves before the event occurs.
  • Sickle cell disease affects more than 80,000 people in the U.S., 98 percent of whom are African American. Sickle cell patients can require frequent blood transfusions throughout their lives.
  • More than 1 million new people are diagnosed with cancer each year. Many of them will need blood, sometimes daily, during their chemotherapy treatment.
  • A single car accident victim can require as many as 100 pints of blood.
  • One donation can save the lives of up to three people.

Go to www.redcrossblood.org to find out more about blood donation and to see if you are eligible.

Kensey Nash Q2 - Edited

Joseph Kaufmann
Our total revenue for the quarter of $21.9 million exceeded prior year by 7% and increased 10% sequentially. Total net sales of $15.1 million exceeded prior year by 12% and increased 14% sequentially. This growth was due to sports medicine, which increased 58% year-over-year and 9% sequentially; and our cardiology products, which are primarily Angio-Seal components, also increased 14% year-over-year and 3% sequentially.
As far as the Angio-Seal collagen sales, again, our third and fourth quarter collagen sales to St. Jude were very good. And we look at the comp compared to last year and our first quarter, it's primarily again due to timing. We expect our second quarter sales to St. Jude will reflect this and will show the improvement.........
It's products, it's quality, it's all that things that you think of every day, and that we think with hopefully some of the new products that we're brining to the marketplace, the biologic products, we believe are going to be a major factor in all of healthcare going forward. And Kensey Nash is going to be a major player in this space, not only in sports medicine, but also in general surgery and in other areas that we're very well positioned with the technology we have built here over the last five to 10 years or so within our organization....

Josh Jennings - Jefferies & Company

And then just last one just on the St. Jude supply agreement. Anymore color you could provide in terms of what happens? I know that's a tiered supply agreement for the component parts, but after 2011, it seems that that minimum 25% does that end in 2011 and you could renegotiate for 2012? And then lastly, is there any risk of the Angio-Seal royalty rate going away at some point?

Joseph Kaufmann

On the supply agreement, it's a two-year deal that starts at January 2011, so it goes out for '11 and '12. And then after that it will be determined whether it will be expanded, increased, decreased, or renewed, I don't know at this time.

As far as royalties are concerned, we are a royalty on Angio-Seal sales. As long as there is at least one claim on any patent, we're entitled to the full 6% royalty, there aren't any step-downs. So as long as there is patents in place that are being utilized, then that's when we continue to receive the royalty.


Sunday, August 22, 2010

‘War is the only proper school for surgeons’

BALAD, Iraq — Army Dr. Colin Meghoo stared at the dry-erase board at Baghdad’s Ibn Sina Hospital. In black marker were the names of the injured, and the procedures chosen to try to save their lives — many of which he had never seen performed.
It was September 2005, and Meghoo, now a lieutenant colonel, had just completed his surgical residency. Trained in repairing the car crash injuries and the occasional gunshot wound that trickled into his Texas emergency room, he now was confronted with the devastating and hugely varied wounds of modern warfare: legs and arms mangled by explosions, arteries severed by bullets, vital organs peppered with shrapnel.
“It was a bit overwhelming,” he recalled, “but then you think to yourself, ‘Wow, this doesn’t even exist in busy civilian hospitals. You need to be in a war zone to see this.’ ”
The ancient Greek physician Hippocrates said that “war is the only proper school for surgeons,” and the war in Iraq has been just that, but with an important development: Lessons were learned and shared immediately.
In the past, doctors had to wait until the gunfire stopped before examining what lessons had emerged.
There are dozens of volumes just about World War II, published long after the war, said Air Force Dr. (Lt. Col.) Raymond Fang, trauma director Landstuhl Regional Medical Center in Germany.
But in Iraq, improvising surgeons and up-to-the minute observational research have resulted in techniques that helped troops survive at a greater rate than in any previous war. Some are high-tech and novel; others were rediscovered; and a few are reinterpretations of old protocols. Moreover, these lessons were documented and shared as the war raged.
Military surgeons have been able to rewrite the book on trauma before U.S. troops have even left the country. “War Surgery in Afghanistan and Iraq: A Series of Cases, 2003-2007” was published by the U.S. Army in 2008, detailing 83 cases from 53 battlefield
doctors.
Now the lessons and techniques tested in Iraq are being honed in Afghanistan, and new ones are being explored.
“It’s not about the next war anymore,” Meghoo said, who recently completed his second tour at Forward Operating Base Sharana near the Afghanistan-Pakistan border.
The advances are needed now.

Stopping the blood
Wars have always birthed medical advancements.
During the Civil War, physicians found new ways to amputate limbs and began using rags soaked in chloroform to anesthetize patients. The typhoid vaccine was developed during World War I, when an Army officer also established the first blood depot. World War II brought the mass use of penicillin, and the Korean War, helicopter evacuation.
One of the legacies of Iraq is a new emphasis on stopping blood loss. Better body armor and helmets protected troops’ vital organs, but high-velocity bullets, rocket-propelled grenades and roadside bombs inflicted the exposed limbs with massive, bleeding wounds.
To stanch the bleeding, doctors turned to one of the oldest and simplest tools in battlefield medicine: the tourniquet. Tourniquets had been maligned and shunned since World War II because of fears that they caused gangrene and limb loss. They do, when used for long periods — but faster evacuation and hospitalization combined with tourniquets saved hundreds of lives in Iraq. A 2008 review of records at the 31st Combat Support Hospital in Baghdad showed that four in seven deaths could have been prevented had a tourniquet been used before the patient arrived.
“This is a simple mechanical thing done since the time of the Egyptians,” Fang said, “and now it’s returning.”
Soldiers in the field are issued one combat application tourniquet, or CAT; some carry more than half a dozen. Slipped around a limb, the tourniquet’s nylon strap is cinched, and the plastic bar on top is twisted, crimping the artery below. The lever is cranked with one hand, so servicemembers can secure their own tourniquets even when badly injured.
Sgt. Chris Bickford, a combat medic who has deployed to Iraq twice, said he trains all his soldiers to clamp on a tourniquet in less than 12 seconds.
“Before we could only use pressure dressings, and there was the chance you may lose the life,” he said. “Now the way the tourniquets are built, allowing them to be placed high on the limb — that saves lives.”
At the start of the Iraq war, innovative clotting agents such as QuikClot were also poured into open wounds. QuikClot, a loose substance made of synthetic absorbents that looks like dry clay, draws water from blood, helping it coagulate. But surgeons often had to pick out the sticky granules, and in some cases QuikClot burned tissue, or even the eyes of the patient on a windy day.
QuikClot’s manufacturer, Z-Medica Corp., soon replaced the loose product with a bag filled with the clotting agent, then, finally, combat gauze treated with it. Medics in the field now push the gauze into wound cavities. The gauze is “easier to carry and much more comfortable for the patient,” Bickford said.
Now the military is looking for alternatives to these synthetic materials, Fang said. One possibility is dried plasma, the liquid part of blood that has proteins and clotting factors. The dried plasma would be revived in a saline solution and then given to wounded troops intravenously or injected into the bone marrow. The latter technique keeps medics from having to search for a vein, a difficult task when soldiers are covered in thick packs and bleeding, said Col. Dallas Hack, director of the Combat Casualty Care Research Program.
“The bone marrow is a fairly large area,”” Hack said, “and you can do it by feel.”
Clinical trials of two forms of dried plasma, one freeze-dried and the other spray-dried, are under way, and it could be in the hands of medics within three to five years, Hack said.
Fang said long-held conventions about blood transfusions also changed. Doctors once pumped saline into hemorrhaging patients to restore hydration, and then added red blood cells and extra platelets. Now surgeons try to “emulate whole blood,” Fang said, forgoing saline and pumping in equal amounts of platelets, cells and plasma.
Before the war, surgeons had regarded the freshness of donor blood as unimportant — as long as it was used within a two-month window. But downrange doctors discovered that fresher red blood cells carry more oxygen, which keeps vital organs working better and provides more oxygen to the brain, helping prevent comas.
“There is a push downrange to use blood that is 14 days old or younger,” Fang said.
At forward operating bases in Iraq, loudspeakers often called for blood donors during periods of heavy fighting. Troops lined up at combat hospitals to donate as the wounded were carried in.
It’s a procedure that has continued in Afghanistan, Meghoo said, even at small outposts.
“You’d put the call out,” he said, “and people would just descend.”
Surgeons like Meghoo also practiced closer to the battlefield than in previous wars, often in the dusty tents of forward operating bases. There, teams lacked many resources of typical trauma hospitals, including imaging equipment such as CAT scanners and fluoroscopes. But they performed minimal yet crucial operations to stabilize a patient, often within the critical “golden hour” after injury, said Dr. (Col.) David P. Blake, director of trauma at the Balad hospital. After the initial lifesaving surgery, patients were taken to Balad, where they were warmed up and given fluids, allowing them to recover enough for the next surgery.
“You control what is immediately going to kill them,” Blake said, “and then you come back another day to address the details.”
Roadside bombs mangled limbs, leaving many soldiers amputees. To prevent this, surgeons improvised with shunts, tiny plastic tubes placed into damaged blood vessels. The combat surgeons found the shunts, which had been used occasionally by vascular surgeons, indispensable to keep blood flowing to troops’ injured limbs, hands or feet until the damaged vessels could be repaired.
Meghoo, for example, had a patient in Afghanistan who was shot in the leg by a high-velocity bullet. The patient’s femoral artery had been severed, and worse, the bullet had burned the edges of the artery, causing it to contract.
“That’s a huge hole,” he said, showing a picture of the gaping wound. “And I can’t sew the [artery] back together because the ends don’t reach anymore.”
To control the flow of blood, Meghoo placed two shunts into the patient’s leg, one in the artery and the other in the vein, and sent him on to another hospital for further care.
In previous wars, Meghoo said, he likely would have bled to death or lost a limb.

Battlefield advances

Devices developed at civilian hospitals were also brought to the battlefield, where doctors found new uses for them.
Before 2004, doctors opened and cleared wounds of blood-soaked gauze and other debris twice daily, a treatment that was painful for patients, but needed to keep their wounds clean. The frequent changing of dressings was common practice for centuries, Fang said, until surgeons at Balad experimented with a vacuum that sucks away the excess fluid, allowing a wound to be sealed for nearly three days.
With negative pressure wound therapy, the wound cavity is covered with a clear plastic bandage with a suction tube attached, then vacuum-sealed. Designed for chronic wounds, the suction helps troops’ tissues heal faster “because all that wound soup is not staying around,” said Lt. Col. Joe Sniezek, director of the Seventh Joint Combat Casualty Research Team.
Better still, patients on long evacuation flights no longer need to have their bloody dressings removed and cleaned in transit.
“It remains to be seen whether the outcome is better,” said Fang, “but it definitely makes it more comfortable for the patients.”
Several high-tech devices were tested for the first time on troops, including an infrared camera that helps doctors detect compartment syndrome, a crimping of the blood vessels in the leg or arm. Deep wounds cause muscle inside the limb to swell, potentially leading to gangrene. The only way to relieve the pressure, or even diagnose compartment syndrome, is to flay the leg or arm muscles open.
The surgery works, said Sniezek, but it’s a “morbid procedure, making an incision all the way down the limb.”
The infrared device, however, allows doctors to detect any difference between the temperatures of the body’s core and the limbs, an indicator that blood is not flowing correctly. If the temperatures are within normal range, surgeons can potentially avoid an unnecessary opening of the limb.
“This is a nice example of how new technologies are being integrated here on the battlefield,” said Sniezek, “and the study is now moving to Afghanistan.”
A cardiothoracic surgeon at Landstuhl was the first to save a patient with the Novalung — a simple-looking slender box with a complex membrane inside that acts as a temporary lung. It connects to blood vessels in the groin, allowing blood to flow from one leg into the box, where it passes through a filter that leaches off the carbon dioxide and infuses the cells with oxygen, mimicking the trade-off that takes place naturally in the lungs. The refreshed blood then returns to body through the other leg.
Unlike a heart-lung machine, the Novalung doesn’t require a mechanical pump because it “works off the body’s own blood pressure,” Fang said.
Approved by European regulators but not yet by the U.S. Food and Drug Administration, the Novalung has been used successfully on about a dozen troops transported to Landstuhl, Fang said. But each time they use it, doctors must submit to the FDA that it is being used to save a life.
“Every time there is a war we learn a lot, because we have to,” said Fang. “And what you learn over years of time is condensed.”
Meghoo recalled using the many lessons that he learned in Iraq during his recent deployment to FOB Sharana, where he was one of two surgeons working in a shed.
“It could be a very lonely feeling,” he said of being away from the safety net of a large hospital with many specialists. “You can’t pass things off to anyone else, and these people have big problems, and you are the only one who can fix them.”
On one occasion an Afghan woman had her right shoulder severed in a mortar attack. Blood gushed from the wound, making it impossible for Meghoo to reach the artery.
“It’s the equivalent of a fire hydrant,” he said. “You can’t go through the water to find the hole. You have to know where the shut-off valve is.”
Meghoo removed part of the woman’s collarbone, and then stemmed the flow of blood by temporarily cinching the artery.
“I remember that case,” he said, “because it was a skill I didn’t have until after I deployed to Iraq.”
The techniques discovered by military surgeons are trickling down to civilian hospitals as well, said Dr. James Dennis, a visiting vascular surgeon at Landstuhl who choked up while talking about the troops with catastrophic injuries whom he had treated in the intensive care unit.
“You can’t help but be moved by what these young people are going through,” said Dennis, whose 25-year-old son Trevor is in the Marines.
Dennis practices at a hospital in Jacksonville, Fla., that recently adopted the military’s protocol when giving blood transfusions to patients with massive injuries.
“They used to learn from us,” Dennis said of military surgeons. “Now we learn from them.”

Saturday, August 21, 2010

FDA Clears All-in-One Reconstitution/Administration Syringe for Xyntha

August 10, 2010 — The US Food and Drug Administration (FDA) has granted 510(k) clearance for a device (Prefilled Dual-Chamber Syringe; Pfizer, Inc) used to reconstitute and administer antihemophilic factor (recombinant) plasma/albumin-free intravenous infusion (Xyntha; Pfizer) in patients with hemophilia A.
The all-in-one syringe is the first to supply freeze-dried albumin-free recombinant factor VIII and also the diluent (0.9% sodium chloride), thereby eliminating the reconstitution transfer step and improving patient convenience.
"For the hemophilia A patient who is always on-the-go, any treatment option that can enhance convenience is critical to the management of his health and lifestyle," said Sue Geraghty, RN, MBA, nurse coordinator, University of Colorado School of Medicine Hemophilia and Thrombosis Center, Denver, in a company news release. "As an all-inclusive, travel-ready kit, the Prefilled Dual-Chamber Syringe offers patients with hemophilia A convenience in reconstituting Xyntha, potentially saving them both time and effort."
The first ready-to-use syringe will be marketed in November 2010 and is designed to provide 3000 IU antihemophilic factor in a 4-mL volume. Lower doses are expected to be available in 2011.
Albumin-free recombinant factor VIII uses a next-generation purification process designed to address the potential risk for murine and other viral contamination. Previously available in single-use vials containing 250, 500, 1000, or 2000 IU freeze-dried powder, the product is indicated for the control and prevention of bleeding episodes and for surgical prophylaxis in patients with hemophilia A.