A CDU

Canadian researchers have issued revised guidelines aimed at helping emergency medical technicians (EMTs) decide when to halt resuscitation procedures for cardiac arrest patients outside hospital.

Dr. Laurie Morrison, lead author, University of Toronto, said the guidelines will help paramedics and doctors decide which patients have the best chance of surviving out-of-hospital cardiac arrest. “Most people die in out-of-hospital cardiac arrest. The survival rate is very low, and we want to be able to identify where further resuscitation is futile and where we could instead support the family. For those that survival is a possibility, we want to get them to the emergency department.”

The new guidelines suggest that resuscitation efforts should stop if:

• Before transportation, no return of spontaneous circulation took place.
• The patient received no shock before transportation started.
• The EMT staff did not eyewitness the cardiac arrest.

The authors of the new guidelines studied records of 1,240 patients in 24 Canadian emergency medical systems. All adult cardiac arrest patients were treated by EMTs trained to use automated external defibrillators. All the patients were followed-up.

They said they found the guidelines to be extremely accurate — predicting death in 99.5% of cases, when termination of resuscitation efforts was recommended. Currently, 100% of patients are taken to an emergency room. By following these guidelines only 37.4% of patients would be taken to an emergency room.

The guidelines appear in the Aug. 3 issue of The New England Journal of Medicine.

Zoll receives Japanese approval of AutoPulse

ZOLL Medical (Chelmsford, Massachusetts), a manufacturer of resuscitation devices and related software solutions, reported receiving approval from the Japanese Ministry of Health, Labour and Welfare (MHLW) to market its AutoPulse Non-invasive Cardiac Support Pump to hospitals and emergency medical services in that country. The product will be sold through its Japanese distributor Nihon Kohden (Tokyo), that country’s largest distributor of medical equipment. In May 2006, ZOLL announced a five-year agreement with Nihon Kohden to market and sell the AutoPulse in Japan.

The AutoPulse is an automated, portable device with a simple, load-distributing LifeBand that squeezes the entire chest in a consistent, uninterrupted “hands-free” manner, delivering maximum blood flow to the heart and brain. Additionally, it offers the benefit of freeing up rescuers to focus on other life-saving interventions.

“We are pleased to help bring this new CPR assist device to hospitals and emergency personnel in Japan,” said Masami Sugiyama, general manager of Import Business Operations for Nihon Kohden. “We believe that this technology has great potential to help professional rescuers improve resuscitation efforts.”

There are an estimated 9,500 hospitals and 88,000 clinics in Japan. In addition, Japan’s Fire and Disaster Management Agency reports about 900 fire defense headquarters around Japan staffed with special rescue teams to provide emergency services.

Sorin reports early data for Freedom Solo

During the 5th joint meeting of EACTS (European Association of Cardiothoracic Surgeons) and ESTS (European Society of Cardio-thoracic Surgery; Stockholm, Sweden), Sept. 10-13 in Stockholm, Sorin Group (Berlin) organized its second investigator meeting concerning the Solo Valve Trial, the European Multicentric Clinical study on Freedom Solo aortic bioprosthesis, a biological pericardial valve.

Preliminary ad interim analysis data confirmed the performances of the product in terms of haemodynamics, recovery of left ventricle systolic function, low early and late-complication associated with friendly implant technique, the company said.

“Freedom Solo represented an innovation in the heart valve prosthesis arena, due to its unique characteristics of being a totally biological valve, virtually identical to the native valve, which can be easily and quickly implanted with a single suture line, giving superior results in terms of haemodynamics. Since its first launch in the market in late 2004, we have implanted almost 150 units at our institution with excellent results,” said Dr. Sven Beholz, Charite Hospital (Berlin).

“Our patients need three new aortic leaflets only to replace their native diseased leaflets. In clinical practice Freedom Solo allows most of the patients to avoid conventional prosthesis with polyester materials. This results in better haemodynamic performances and an improved patient well-being”, said Dr. Alberto Repossini of Istituto Clinico Humanitas-Gavazzeni (Bergamo, Italy), the first worldwide implanter of Freedom Solo in 2004.

This aortic valve has no rigid support that other biological valves have, so-called stented valves, in order to secure them. Such design allows Freedom Solo to have a better haemodynamic performance without making the implant procedure more complex, since a single suture line only is required, the company said. Due to its recent implant of Freedom Solo, the Zwolle hospital center in the Netherlands is the 100th user center of Freedom Solo in Europe.

VentrAssist BTT CE-mark results unveiled

The clinical results of the VentrAssist left ventricular assist device (LVAD) CE Mark bridge-to-transplant (BTT) trial were presented at the European Association of Cardiothoracic Surgeons (Windsor, UK; EACTS) in Stockholm last month. The primary clinical end-point of the trial was cardiac transplant or continued transplant-eligible at 154 days after a VentrAssist implant. The VentrAssist, manufactured by Ventracor (Sydney, Australia), demonstrated an 83% success rate in the trial, which the company termed “significantly better than the earlier published results of first generation devices, reported to be 65%.” The adverse event rate was “in line with expectations,” it said.

The VentrAssist is a third-generation centrifugal implantable blood pump designed for long-term use in patients with advanced heart failure. It is primarily intended as therapy for patients who are not eligible for a heart transplant, as well as for use as a bridge-to-transplant and as a potential bridge-to-recovery. The blood pump has no parts that can wear out.

Ventracor said that the clinical results are the subject of a major report which it expects to submit “soon” as the next step to obtain CE-mark approval.

Abbott opens new facility in Ireland

Abbott Laboratories (Abbott Park, Illinois) has continued expansion of its Abbott Vascular sites in Ireland with the opening of a 180,000-square-foot manufacturing facility in Clonmel. The company also unveiled architectural drawings for an additional 70,000-square-foot administration, warehouse and logistics facility to accommodate future growth in Clonmel.

“Expansion to accommodate new facilities and additional personnel is necessary as we develop and deliver the highest-quality lifesaving devices and treatments for vascular disease — particularly in emerging therapies such as drug-eluting, carotid and bioabsorbable stents,” said Pat Ryan, vice president, Manufacturing Operations, Cardiac Therapies.

Abbott said the Clonmel and Galway sites play an important role in Vascular’s drug-eluting stent (DES) manufacturing operations. It said it plans to initiate European launch of its first DES, the Xience V everolimus-eluting coronary DES, next month. Abbott is awaiting CE mark approval for its ZoMaxx DES.

Abbott’s Galway operation was also recently granted permission to build a new 150,000-square-foot facility manufacturing/lab/office facility.