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 Complication N=30 (% of procedures) Pneumothorax 2 (2.8) Hypoxemia 5 (20.8) Reintubation 3 (12.5) ST-segment changes 3 (12.5) Bradycardia 6 (25) Tachycardia 3 (12.5) Hypotension 7 (29) Death 1 (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.