Warm Ischemia Worsens Partial Nephrectomy Outcomes, Study Finds

Warm ischemia during partial nephrectomy (PN) on a solitary kidney is associated with an increased risk of acute renal failure (ARF) and CKD, according to researchers.
Consequently, they concluded, “PN with no ischemia should be used when technically feasible in patients with solitary kidney.”
R. Houston Thompson, MD, of Mayo Clinic in Rochester, Minn., and collaborators studied 458 patients who underwent open PN (411 patients) or laparoscopic PN (47 patients) for a renal mass in a solitary kidney. The researchers excluded patients treated with cold ischemia. They explained that no ischemia was used if a tumor was sufficiently exophytic or in a position where regional compression could provide sufficient hemostasis during tumor enucleation.
No ischemia was used in 96 patients (21%), whereas 362 patients (79%) had a median of 21 minutes of warm ischemia (achieved with hilar clamping). Compared with the no-ischemia patients, warm ischemia patients had a significant twofold increased risk of ARF and a fourfold increased risk of having a glomerular filtration rate (GFR) below 15 mL/min/1.73 m2 in the post-operative period, the investigators reported in European Urology (published online ahead of print).
In addition, of 297 patients with a preoperative GFR of 30 or higher, those treated with warm ischemia had a significant 2.3 times increased risk of new-onset stage IV CKD during a mean follow-up of 3.3 years.
“We do not submit that clamping should be avoided at all costs but rather support the use of no clamping in select patients with a tumor that is amenable to manual compression,” the researchers noted.
Dr. Thompson's group noted that their study is limited by its retrospective design. In addition, they pointed out that their study had a significant selection bias. Patients managed with no ischemia were likely to have more exophytic and smaller tumors that presented a lower risk of complications.

FDA Warns on Fibrin Sealant Problem

Air embolisms can occur with some gas- or air-pressurized spray devices used for applying fibrin-based bleeding control products when used improperly during surgery, the FDA warned.
At least seven types of fibrin sealant sprayers were associated with air or gas embolisms, which appear to have occurred when pressure settings were too high or the sprayer tip was too close to the bleeding site.
The FDA emphasized that clinicians should follow manufacturers’ recommendations for pressure control settings and the minimum distance for applying the sealants.
“Although rare, the reports describe air embolisms that are life threatening and include one fatality,” the FDA said.
The bureau listed seven product series that have been affected:
EasySpray and spray set used with Duploject system (Baxter Healthcare)Tissomat and spray set used with Duploject system (Baxter Healthcare)Evicel application device (Omrix Medical)FibriJet Aerosol Applicator (MicroMedics)HemaMyst Surgical Applicator System (Haemacure)MicroMyst Applicator and Air Pump Models 20-5000 and AP-A-6063 (Confluent Surgical)Vitagel Hemostat Spray Set (Orthovita)
Label instructions for all fibrin sealants have been rewritten to note the risk of air embolismsassociated with improper sprayer use.
In addition to following the listed recommendations for pressure settings and proper distances for application, clinicians should be sure to monitor patients’ blood pressure, pulse, oxygen saturation, and end-tidal CO2 levels for signs of embolism, the FDA noted.
The sprayers should also be maintained and tested regularly, the bureau said.

Department of Defense Funding Shows Continued and Bi-Partisan Support for STB® Lifesaving Technologies' Products

ROCKVILLE, Md., July 7 /PRNewswire/ -- For the third consecutive year the Department of Defense demonstrated its commitment to help save the lives of our troops by providing STB Lifesaving Technologies® with $2.85 million of funding.
The award is to further advance the development of STB®'s Fibrin Adhesive STat (FAST®) dressing, designed to be effective against the full spectrum of blood loss, including severe arterial and venous bleeding. Fifty percent or more combat-related deaths are attributable to uncontrolled hemorrhaging, and with products such as this, thousands of military and civilian lives could be saved.
"We are most appreciative of the support we have continued to receive from the Department of Defense and members of both the Senate and House. This funding is not only invaluable; it serves as a strong statement of their belief in our Fibrin Adhesive STat (FAST®) dressing and their commitment to help us bring our products to the battlefield, emergency responders and operating rooms," said STB® CEO, Richard Moscarello.
Funding for the grant was included in the FY2009 U.S. Department of Defense appropriations bill and received bipartisan support from Senators Richard Burr (R-NC), Ben Cardin (D-MD), Barbara Mikulski (D-MD), Charles Schumer (D-NY) and former Senator Elizabeth Dole (R-NC) and Representatives Bob Etheridge (D-NC), David Price (D-NC) and Chris Van Hollen (D-MD).
"We've all been encouraged by the pre-clinical studies, but it's particularly gratifying that support for our science is backed with significant monetary commitments as well," said STB®'s Moscarello.

About STB®

Founded in 2005, STB Lifesaving Technologies® (STB®) is a privately held, pre-clinical stage, biotechnology development company located in Rockville, Maryland. STB® which stands for "stop the bleeding", is focused on developing a comprehensive suite of products to stop serious and life threatening bleeding in trauma and surgical settings. With a strong proprietary position using its all-natural protein technology with five patents and one provisional patent pending, STB®'s products will be indispensable to both the military and civilian medical markets.

Ethicon, Inc. Expands Hemostasis Product Portfolio with Approval of the Company's First Synthetic Internal Use Sealant

SOMERVILLE, N.J., July 7, 2010 /PRNewswire via COMTEX/ -- Ethicon, Inc., a worldwide leader in surgical care, announced today the introduction of ETHICON(TM) OMNEX(TM) Surgical Sealant, ETHICON(TM) Biosurgery's first synthetic sealant designed to achieve adjunctive hemostasis (stoppage of bleeding) in vascular reconstructions by mechanically sealing areas of leakage. The US Food and Drug Administration (FDA) recently granted approval of the Premarket Approval Application (PMA) for ETHICON(TM) OMNEX(TM) Surgical Sealant.

ETHICON(TM) OMNEX(TM) creates a strong, flexible physical seal independent of the body's clotting mechanisms. It is proven in an ex-vivo model to be two-to-four times as strong as other surgical sealants, is ready for use in less than 30 seconds, and proven to seal to ePTFE grafts and bond securely to friable vessels.(1)

"A basic rule of patient safety and excellent outcomes is to prevent unnecessary bleeding during and immediately after surgery," said Alan B. Lumsden MD, Medical Director of the Methodist DeBakey Heart & Vascular Center and the Chairman of the Department of Cardiovascular Surgery at The Methodist Hospital in Houston.* "The availability of an effective surgical sealant such as ETHICON(TM) OMNEX(TM) provides surgeons with a valuable new tool that is clinically proven to decrease the time it takes to seal the surgical site, including ePTFE grafts, and prevent leakage from occurring."ETHICON(TM) OMNEX(TM) is clinically proven to significantly decrease time to hemostasis based on clinical trials conducted to support its safety and effectiveness. Specifically, results from a pivotal, randomized, controlled, open-label, multi-center trial of 151 patients at 13 centers in the United States and European Union demonstrated that ETHICON(TM) OMNEX(TM) provided hemostasis three times faster than oxidized regenerated cellulose at a rate of 1.99 minutes vs 6.73 minutes, with 54 percent of the ETHICON(TM) OMNEX(TM) patients receiving immediate hemostasis.(2) There were no significant differences in adverse events compared to oxidized regenerated cellulose during the study time period and 4+ year follow-up analysis.(2)

ETHICON(TM) OMNEX(TM) Surgical Sealant has proven efficacy in a broad spectrum of vascular reconstructive procedures including arteriovenous access, aortobifemoral bypass, femoral popliteal bypass, endarterectomy, abdominal aortic aneurysm and aortotomies.(1)

ETHICON(TM) OMNEX(TM) Surgical Sealant is contraindicated in patients with known hypersensitivity to cyanoacrylate or formaldehyde. The device is not for intravascular use. ETHICON(TM) OMNEX(TM) Surgical Sealant is intended for use as an adjunctive sealant and is not to be used in place of sutures, staples, or mechanical closure.

Hemostase - Medafor states CryoLife Press Release is Misleading and False

Please click the thumbnail to read.

PS - Happy Independence Day!

Hemostase: Medafor says its off...CryoLife its on.......

NOT SO FAST, MY FRIEND!

The continued quagmire that is the CryoLife/Medafor relationship appears set to continue according to This latest Press Release from CryoLife.

Background

After a failed takeover bid by CryoLife they encouraged Medafor shareholder's to withhold their votes at a recent Medafor shareholder meeting. This was rejected by 95% of the 70% of attendee's and one disappointed shareholder will no doubt be Jim Karerchersuch who commented "I say get rid of CryoLife and let investors make some money,".

Expenses in the tussle continue to escalate for both companies with Medafor CEO Shope stating... "The real problem for Medafor is the distraction and expense stemming from CryoLife's takeover bid and continuing litigation, Shope said. Had it not been for the $1.2 million the company shelled out for legal expenses last year, Medafor would have been profitable, ."

and another online source stating ...."Anderson, who launched the hostile takeover attempt of Medafor in 2009 and chose several public venues to prosecute his case, spent approximately $6 million in the effort."

Conclusions

For those on the sidelines this extremely public battle has been an intriguing insight. Lately barely concealed personal attacks are now appearing in certain news articles relating to CryoLife CEO Steven Andersons, age and absence from the shareholder meeting despite his residence in MN. Meanwhile Medafor management were brought under the spotlight with the CryoLife claim "that Medafor's CEO and chief financial officer earned a combined $700,000 last year." Medafor management also denied any issues related to the fact that Medafor senior executives, and Pennsylvania residents Shope and Pasquale don't live in Minnesota, where the company's 21 employees are based. With Pasquale claiming it isn't necessary to live locally.

Investors and Distributors must be feeling unsettled by the lack of clarity in terms of supply, and without any public statement from Medafor or the courts (where both companies appear more comfortable communicating) the status quo appears confusing.

One positive indication from this mess is that plant-based hemostatic technology is certainly worth fighting for. Medafor partner Orthovita must have an eye on these occurences, as will other key China manufacturer Starch Medical.

HemCon Medical Technologies Introduces GuardIVa™

PORTLAND, Ore., and DUBLIN, Ohio, June 23, 2010 — HemCon Medical Technologies Inc. today announced the launch of the HemCon© GuardIVa™ Antimicrobial Hemostatic IV Dressing, the only antimicrobial dressing containing both a hemostatic compound and the antiseptic agent chlorhexidine gluconate (CHG). The company also announced a five-year sole-source distribution agreement with Cardinal Health to provide the new dressing to hospitals and surgery centers in single sterile units and within Cardinal Health Presource® procedure packs.

Because of its proprietary hemostatic compound, GuardIVa can be used in the first 24 hours after placement of IV devices to control bleeding and provide immediate antimicrobial protection to the IV site. GuardIVa is also able to absorb up to 11 times its own weight in fluid, reducing the need for frequent dressing changes.

GuardIVa’s CHG base also provides more effective and sustained antimicrobial activity over a seven-day span than the silver base used in other antimicrobial dressings.¹ The use of CHG-based dressings helps protect against micro-organisms such as Methicillin-resistant Staphylococcus aureus (MRSA) and Methicillin-Resistant Staphylococcus epidermidis (MRSE).

“GuardIVa’s superior hemostatic and antimicrobial qualities reduce the need for frequent dressing changes and provide a complete and cost-effective solution to help drive patient safety and IV site infection management,” said John W. Morgan, CEO of HemCon Medical Technologies, Inc. “We’re excited to be able to partner with Cardinal Health to extend this complete IV site care solution to its customer base of infection specialists and health care professionals leading the charge for infection control.”

Central Venous Catheters (CVCs) and Peripherally Inserted Central Catheters (PICCs) are among the ideal applications for GuardIVa.

“We know there is a heightened focus on infection prevention, especially as it relates to catheter-related bloodstream infections,” said Debra Schotz, senior vice president of Patient Care at Cardinal Health. “By including GuardIVa in our portfolio in addition to our full line of Presource standard and custom kits, we’re helping our customers comply with recommendations from the Institute for Healthcare Improvement calling for maximal barrier protection and a kit or central line bundle to improve compliance for catheter insertion and maintenance procedures.” ²

For product information, Cardinal Health customers should contact their nursing products or Presource sales representative. Information is also available through Cardinal Health by calling Jaime Simon at (614) 553-4663 for single sterile use or Crystal Humphreys at (614) 553-5263 for in-kit use.

Filtering donor blood cuts cardiac risk, lung complications

Washington, June 22 (ANI): Scientists have found another reason to filter the foreign white cells from donor blood-it dramatically reduces cardiopulmonary complications for patients who received a transfusion.
The study by researchers at the University of Rochester Medical Center (URMC), is the latest in a large body of work led by Dr. Neil Blumberg, who for 25 years has been investigating the benefits of filtering or washing blood to create safer, simpler approaches to transfusion therapy.
The observational study was conducted during the seven years before and after 2000, when the URMC introduced universal leukoreduction, a process that filters the white cells from blood to be used for transfusions.
Researchers looked at the number of reports of transfusion reactions during the 14-year period, and divided them by the total number of blood components transfused (778, 559).
Rates of acute, transfusion-related lung injury dropped 83 percent in the years after filtering took place, and transfusion-associated circulatory overload declined 49 percent, when compared to the rates prior to the year 2000.
Both conditions are rare, but are among the most common causes of death following a transfusion.
"These data are very exciting because we described two unexpected and unexplained associations between adverse reactions and leukoreduction. However, our observations do not prove cause and effect, and therefore require further investigation before we can say with certainty that leukoreduction is responsible for so many fewer cardiopulmonary complications," said Blumberg.
The Centers for Disease Control and Prevention is introducing a new blood surveillance system to track severe transfusion reactions, which should provide more detailed information to support or refute the study, said Blumberg.
Earlier, the researchers have shown that the odds of post-surgical infection and death are greatly reduced by leukoreduction.
White cells from donor blood can attack the immune system of the blood recipient; removing them diminishes the chances of an inflammatory response or infection, according to Blumberg's research.
The study is published online in the journal, Transfusion.

Investigators Perfect New Version of Blood-Regulator Thrombin

ST. LOUIS, June 18 /PRNewswire-USNewswire/ -- In research led by a Saint Louis University investigator, molecular biologists have discovered a way to harness the enzyme thrombin's anti-blood clotting properties. The finding opens the door to new medications that will treat diseases related to thrombosis, the presence of blood clots in blood vessels, which is responsible for nearly a third of all deaths in the U.S.

"Thrombosis is one of the most prevalent causes of fatal disease," said lead researcher Enrico Di Cera, M.D., chair of the department of biochemistry and molecular biology at Saint Louis University School of Medicine. "If we could develop an anti-thrombotic drug that didn't carry a risk of hemorrhage, it would revolutionize the treatment of cardiovascular disease, the leading cause of death in the U.S. and Western world.

"This research carries us closer to that goal."

Blood clotting has long ensured our survival, stopping blood loss after an injury. On the other hand, if triggered in the wrong conditions, clotting can lead to debilitating or fatal conditions like heart attack, stroke and deep vein thrombosis.

Funded by the National Institutes of Health, and published in the June 18, 2010 edition of The Journal of Biological Chemistry (Vol. 285. No. 25), researchers zeroed in on thrombin, a vitamin K-dependent enzyme key to blood coagulation.

An unusual enzyme, thrombin performs distinct and even opposing functions, acting as a pro-coagulant, pro-thrombotic but also as an anti-coagulant factor depending on which target protein - fibrinogen, PAR1 or protein C - becomes activated in the blood. Researchers studied thrombin to decipher the structure-function code that enables this protein to do so many different things.

Tackling this problem far below the level of tissue and organs, molecular biologists looked deep inside the structure, examining thrombin's amino acids to note how they behave and interact with each other.

Using protein engineering, researchers produced mutations in the enzyme's amino acid sequence, carefully taking out pieces and replacing them, a few at a time, to find the exact locations that influence the function of thrombin. Once they found these "hot spots," researchers went even further - trying each of the 20 natural amino acids to see which mutation would allow them to turn on and off the pro-coagulant, pro-thrombotic and anti-coagulant functions.

"We asked the question, what if we can take this enzyme and dissociate the functions, allowing only the function we want?" said Di Cera.

In earlier research, Di Cera's team did just that. They engineered thrombin to promote activity toward protein C - the anticoagulant target protein - and minimize activity toward fibrinogen and PAR1 - the procoagulant and prothrombotic targets.

"In 2000, we engineered a thrombin mutant with potent anticoagulant properties both in vitro and in vivo and we are moving this mutant to a phase I trial," said Di Cera. "In this study, however, we pressed further. We wanted to optimize this mutant to completely abrogate activity toward fibrinogen and PAR1."

"With this research we optimized the mutant so that there is no clotting at all. Furthermore, we generated a new mutant with exclusive prothrombotic activity, thereby demonstrating that the individual functions of thrombin can be dissociated by replacing a single amino acid in the protein."

Once clinical trials are performed, researchers hope to have developed an alternative to heparin, a blood thinner that is used to prevent blood clots and is often used before surgery, but which also causes allergic reactions, dosage challenges and bleeding.

"Heparin is a brute-force remedy that shuts down all thrombin functions, including its beneficial anti-coagulant role," said Di Cera. "Our approach is a new strategy that like a smart bomb only targets the functions we want to turn off."

Established in 1836, Saint Louis University School of Medicine has the distinction of awarding the first medical degree west of the Mississippi River. The school educates physicians and biomedical scientists, conducts medical research, and provides health care on a local, national and international level. Research at the school seeks new cures and treatments in five key areas: cancer, liver disease, heart/lung disease, aging and brain disease, and infectious disease.

No More Hemostase - Marriage from Hell ends

Under the headline "Medafor Shareholders Crush Cryolife" a new article, states ....." Medafor has decided to end its distribution relationship with CryoLife. Over the past 24 months Medafor has supplied CryoLife with its flagship product—a patented absorbable hemostasis powder which promotes rapid clotting. According to CryoLife CEO Anderson, losing the rights to distribute Medafor’s innovative hemostat will cost the company as much as $6 million in lost annual revenues.

It is probably worth noting that in 2009 CryoLife reported a precipitous decline in reported after-tax earnings from $32.9 million (2008) to $8.6 million (2009). CryoLife’s COO stated that losing the Medafor product would materially adversely affect CryoLife.

In retrospect, one has to ask the question: What were the guys at CryoLife thinking? Not only is roughly $6 million flushed away but now they will lose one of the strongest product lines."

The full article is available HERE