UH Case Medical Center LEADLESS II trial part of worldwide effort to go wireless

CLEVELAND, Nov. 10, 2014 /PRNewswire/ -- Wireless is always better, but the transition into health care–specifically as it pertains to cardiology and pacemakers–is testing that theory.

University Hospitals (UH) Case Medical Center is among 60 worldwide sites studying a new leadless cardiac pacemaker system. The device, called Nanostim and made by St. Jude Medical, is implanted using a minimally invasive procedure, delivered by a catheter through the groin, cutting implant time in half and decreasing recovery from four months to three days, all without an incision.

Almost 700 patients from across the globe, 50 percent from within the United States, will participate in the non-randomized clinical safety and effectiveness investigation called LEADLESS II.  In addition to testing the efficacy of the new device, the study will compare the newest technology against the traditional implant.

Of the many differences between the Nanostim  and traditional pacemaker devices is the wireless technology. Traditional devices require leads in the veins that can complicate surgical and post-operative care.

Additionally, the LEADLESS II device is considerably smaller. Older devices are the size of a coffee ring and the pacemaker invasively protrudes out of the skin while the Nanostim is just smaller than a crayon and it affords patients more comfort. The device, resembling a small, metal silver tube, is only a few centimeters in length, making it less than ten percent the size of a traditional pacemaker.

Instead of radio frequency, conductive telemetry is utilized which allows for more efficient battery usage as well as physician regulation and manipulation.

Similar to other cardiac pacemakers, the Nanostim device treats a heart rate that is too slow called bradycardia. It works by monitoring the heart's electrical rhythms and provides electrical stimulation to regulate it.

The new LEADLESS II does not require nearly as many restrictions with it either. Normal post-operative care involves restricted activity for up to a month but with the new technology, the average patient is allowed to return to activity within 72 hours. Operating time too has been cut by 50 percent from a standard two-hour procedure to an hour.  Repeat procedures and occlusions have also been reduced in the early stages of the trial.

"We have been experiencing incredible success thus far with this innovative, non-surgical pacemaker option for our patients," said Judith Mackall,MD, Director of Electrophysiology at UH Case Medical Center and Associate Professor, Medicine, Case Western Reserve University School of Medicine. "This technology is improving multiple aspects of patient care. As surgeons this is an avenue that allows for better, quicker outcomes with fewer risks."

Harish Manyam, MD, Electrophysiologist at UH and Clinical Assistant Professor, Medicine, Case Western Reserve University School of Medicine, who is also part of the trial for UH Case Medical Center, noted that the Nanostim has dramatically improved outcomes and improved patient safety.

"The old technology consisted of the device and connecting wires," he said. "The downside to having a lead, though still effective, is that it can fracture, get infected and carry more risks with it. The Nanostim is demonstrating initially that it will last longer for patients who don't require the device as much."

UH Case Medical Center is currently enrolling patients for the trial and information can be obtained by calling 216-844-8917.

About University Hospitals
University Hospitals, the second largest employer in Northeast Ohio with 25,000 employees, serves the needs of patients through an integrated network of 15 hospitals, 28 outpatient health centers and primary care physician offices in 15 counties. At the core of our $3.5 billion health system is University Hospitals Case Medical Center, ranked among America's 50 best hospitals by U.S. News & World Report in all 12 methodology-ranked specialties. The primary affiliate of Case Western Reserve University School of Medicine, UH Case Medical Center is home to some of the most prestigious clinical and research centers of excellence in the nation, including cancer, pediatrics, women's health, orthopaedics, radiology, neuroscience, cardiology and cardiovascular surgery, digestive health, transplantation and genetics. Its main campus includes UH Rainbow Babies & Children's Hospital, ranked among the top children's hospitals in the nation; UH MacDonald Women's Hospital, Ohio's only hospital for women; and UH Seidman Cancer Center, part of the NCI-designated Case Comprehensive Cancer Center at Case Western Reserve University. For more information, go to www.uhhospitals.org.

SOURCE University Hospitals Case Medical Center

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