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Landmark Study Asks the Question: Are All Defibrillators Created Equal?

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Landmark Study Asks the Question: Are All Defibrillators Created Equal?

First U.S. Patients Enrolled in International Trial to Evaluate Implanted Defibrillator that Offers Protection with Less Risk to the Heart

RIDGEWOOD, NJ, February 12, 2015 — The Valley Hospital has been selected as the United States Coordinating Center for the PRAETORIAN trial, an international trial designed to compare for the first time the traditional implantable cardioverter-defibrillator (ICD) with a newer model that may reduce the risk of complications associated with these otherwise life saving devices.

Although ICDs have been used for decades to safeguard patients deemed at high risk for sudden death due to a heart rhythm disorder (arrhythmia), the traditional model relies on a transvenous electrode or lead placed in the heart. A major drawback of these ICDs has been the lead, which can break, become infected, or injure the heart and surrounding blood vessels. The alternative is a newer form of ICD, called a subcutaneous or S-ICD that is implanted entirely under the skin without entering the heart or blood vessels. Valley was one of the first hospitals in New Jersey and one of only three hospitals in the tri-state area to have early experience with the S-ICD.

“Both types of ICDs have been shown to reduce the risk of sudden death,” says Suneet Mittal, M.D., Direct of Electrophysiology and the Principal Investigator at Valley for the Praetorian Trial. “The S-ICD, because it does not involve a lead within the heart, may significantly reduce the likelihood of lead-related complications. This trial is the first attempt to compare the two types of ICDs in a randomized trial.”

In the PRAETORIAN trial, which originated at the Academic Medical Center in Amsterdam, the Netherlands, patients are randomly selected to receive either a traditional ICD or an S-ICD. Mark W. Preminger, M.D., Director, Implantable Arrhythmia Devices at Valley, enrolled the first patients in the United States into the study earlier this month.

“The S-ICD® is the world’s only subcutaneous ICD, and it represents a major step forward in the evolution of defibrillator technology,” Dr. Mittal says. “We are delighted to offer this advanced breakthrough in arrhythmia treatment to our Valley Hospital patients, and proud to be a leading participant in this important international trial.”

For more information please visit www.clinicaltrials.gov.

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Meet Noelle and Baby Hal, Valley’s Medical “Robots”

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Meet Noelle and Baby Hal, Valley’s Medical “Robots”
March 10, 2014

Ridgewood NJ , In a private room at The Valley Hospital Center for Childbirth, Noelle is about to give birth to her first child.  One minute everything seems fine; the next the labor and delivery team spring into emergency response mode as the obstetrician detects the signs of shoulder dystocia, an obstetrical emergency in which the head is delivered but one of the shoulders fails to pass through the pelvis and is “stuck.”

As they have been well-trained to do, the team responds quickly and baby Hal is delivered safely. But Noelle is in no condition to appreciate their work.  Noelle is essentially a robot — a full-sized, blond mannequin that can give birth and be used to simulate a wide range of obstetrical, medical and surgical emergencies.

Valley purchased the Noelle Maternal and Neonatal Birthing Simulator and Newborn Hal through grants from The Van Houten Foundation and The Valley Hospital Foundation. A five-year-old Hal mannequin has also been purchased.  The high-tech mannequins are the cornerstone of Valley’s simulation training program, which has been underway for about a year.  Future plans include the establishment of a Simulation Laboratory funded by a $2.5 million grant from the Foundation’s Board of Trustees.

Simulated emergencies have been implemented in the OR and Center for Childbirth and are planned to expand into other areas of the hospital.  The obvious benefit of simulation training is that it may be accomplished with absolutely no risk to the patient and allows nurses, physicians and other members of the healthcare team to practice and review their performance before being faced with a live patient.  “This is particularly valuable in the case of high-risk, low-frequency occurrences, which staff may not see often in their careers,” said Beth McGovern, clinical practice specialist at Valley and one of the simulation educators.

“It also fosters teamwork between different disciplines as all members of the team work together on the simulation exercises, which can improve processes and patient safety,” McGovern said.  The Institute of Medicine has recommended interdisciplinary team training programs as one way to encourage a “culture of safety” that makes patient safety a top priority.  “In a simulation exercise, we have physicians, nurses, techs, and other members of the healthcare team working training side-by-side, which mimics what happens in a real medical emergency,” McGovern said.

Above photo :  Medical simulator “Noelle” gives birth to a healthy baby boy as part of a simulation training drill in The Valley Hospital’s Center for Childbirth.  Baby “Hal” was delivered by OB/GYN Roger Coven, M.D., with the assistance of Beth McGovern (left) clinical practice specialist, and labor & delivery nurse Jamie DeVisser. During the drill the team ran through the steps required to respond to shoulder dystocia, an obstetrical emergency in which the head is delivered but one of the shoulders fails to pass through the pelvis and is “stuck.”