Archive - May 1, 2012

Archive - May 1, 2012


FDA Votes in Favor of Use of Subcutaneous ICD in Appropriate Patient Populations

The FDA Circulatory System Devices Panel of the Medical Devices Advisory Committee voted 7-1 that the benefits of Cameron Health’s subcutaneous implantable cardioverter defibrillator outweigh the risks when used in the appropriate patient population.

In a 7-1 vote, panel members deemed the device effective and unanimously agreed that it is safe in patients for whom the device is indicated.

“The operational word here is reasonable assurance of safety and effectiveness,”John C. Somberg, MD, of the Rush University Medical Center, said. “We have an expedited review and a small patient population that I believe is reasonable.”

However, David Milan, MD, of Massachusetts General Hospital and Harvard Medical School, said it is important to balance the enthusiasm for a new technology with caution to ensure that standards for efficacy remain high.

World Champion Swimmer, 26, Dies from Sudden Cardiac Arrest

STOCKHOLM (AP) - Alexander Dale Oen, a world champion swimmer who was one of Norway's top medal hopes for the London Olympics, died during a training camp in Flagstaff, Arizona. He was 26.

The president of the Norwegian swimming federation, Per Rune Eknes, told The Associated Press in a phone interview that Dale Oen died after suffering a cardiac arrest.

In a statement, the federation said the 100-meter breaststroke world champion was found collapsed on the floor of his bathroom late Monday. He was taken to the Flagstaff Medical Center, where he was pronounced dead.

"We're all in shock," Norway Coach Petter Loevberg said. "This is an out-of-the-body experience for the whole team over here. Our thoughts primarily go to his family who have lost Alexander way too early."

Hospital spokeswoman Starla Collins confirmed the death, but did not provide further details.

City of Billings Sued for Lack of Response and AED in Case of Sudden Death of Swimmer at Community Pool

BILLINGS, MT--The family of a Billings man who died of a heart attack during an outing at Rose Park pool is suing the city of Billings for failing to provide for the safety of pool users.

Bart Bieber, then 41, died on July 24, 2011, during a visit to the pool with his wife, Therese, and their three minor children. The lawsuit was filed April 12 by Billings attorney John Heenan on behalf of Therese Bieber and her children.

The suit says Bart Bieber was in good physical shape and had never suffered heart trauma, but when he emerged from the Rose Park pool on July 24, “he was in sudden ventricular fibrillation.”

An off-duty firefighter and Therese Bieber, who is a nurse at Billings Clinic, began administering CPR to Bieber, the suit says, but no lifeguard or other pool employee called 911 to ask for medical assistance.

Most ICD Patients Die of Heart Failure

Patients with implantable defibrillators (ICDs) or resynchronization devices with defibrillator (CRT-Ds) were most likely to die of heart failure or noncardiac causes, not sudden death, a single-center study found.

Of the 2,859 patients included in the analysis, the 8-year cumulative incidence for heart failure death was 8.6% among patients with an ICD for primary prevention and 9.6% among secondary prevention ICD patients, and 22.6% for those with a CRT-D (log rankP<0.001), reported Martin J. Schalij, MD, PhD, and colleagues from Leiden University Medical Center in Leiden, The Netherlands.

Conversely, the 8-year cumulative incidence of sudden death was 2.1% and 3.2% in the primary and secondary prevention ICD patients, and 3.6% in those with a CRT-D (log rank P=0.026), according to the study published online in the journal HeartRhythm.

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