New Jersey’s First Dual-Chamber Leadless Pacemakers Implanted at Jersey Shore University Medical Center

The cardiovascular team at Hackensack Meridian Jersey Shore University Medical Center recently implanted New Jersey’s first dual-chamber leadless pacemaker systems in patients, as part of Abbott’s AveirTM DR i2i clinical study.  

People who experience a slower-than-normal heart rate may receive a pacemaker; a small battery-powered device implanted in the chest that delivers electrical impulses via thin insulated wires, called cardiac leads.  The leads cause the heart muscle chambers to contract to help restore a normal heart rhythm.  Unlike traditional pacemakers, leadless pacemakers are implanted directly into the heart through a minimally invasive catheter-based procedure and eliminate the need for cardiac leads.  Nearly two million Americans have a pacemaker implantation. 

Electrophysiologist Mark Mascarenhas, M.D., implanted the first dual-chamber leadless pacemakers at Jersey Shore University Medical Center. “Providing this new system is a landmark moment for people requiring assistance to maintain a healthy heart rhythm,” said Dr. Mascarenhas.  Leadless pacing options have been limited to single-chamber devices until now since synchronization of two leadless pacemakers has been highly difficult to achieve.

Medical device company Abbott designed their i2i technology to provide beat-by-beat communication between two leadless pacemakers, one positioned in the right ventricle and one positioned in the right atrium of the heart.  This technology is designed to regulate the heart rate synchronously between chambers allowing for dual-chamber leadless pacing. 

“This is incredibly significant as nearly 80 percent of people who receive a pacemaker need a dual-chamber option to pace both chambers on the right side of the heart, “ said Dr. Mascarenhas. “While leadless pacemakers work like traditional pacemakers to regulate heart rate, they offer reduced lead-related complications and a less restrictive recovery period due to the minimally invasive implant procedure.  This technology is a great enhancement in what we can provide to our patients with abnormal heart rhythms.”

For more than 10 years, Jersey Shore University Medical Center has been a leader in New Jersey in performing diagnostic and interventional cardiac procedures.  “Providing this type of innovative pacemaking technology is in line with our mission to provide the best care, advanced healthcare technology and medical expertise to all our patients,” said Vito Buccellato, MPA, LNHA, president and chief hospital executive, Jersey Shore University Medical Center. 

In 2021, the academic medical center launched a $45 million, invasive cardiovascular expansion project.   “We are creating a centralized, convenient space to improve the experiences of our patients and their loved ones and providing our cardiovascular experts with leading-edge tools to enhance care,” said Kenneth N. Sable, M.D., MBA, FACEP, regional president, Southern Market, Hackensack Meridian Health. 

For information about Hackensack Meridian Health and Jersey Shore University Medical Center’s cardiovascular services, visit www.hackensackmeridianhealth.org/en/Services/Heart-Care. For a free physician referral, call 844-HMH-WELL.

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ABOUT THE AVEIR DR I2I STUDY

The Aveir DR i2i study is a prospective, multicenter, international, single-arm, pivotal investigational study designed to evaluate the clinical safety and efficacy of the Aveir DR leadless pacemaker in patients who were indicated for a DDD(R) – or dual-chamber bradycardia pacing – pacemaker, which stimulates the appropriate chamber of the heart when clinically necessary. The study plan is to enroll up to 550 patients from up to 80 sites in the U.S., Canada, Europe and Asia-Pacific, and all patients will be followed for a minimum of 12 months post-implant.

The Aveir DR i2i leadless pacemaker is an investigational device being clinically evaluated as part of a global pivotal study and is not yet commercially available. The device design specifications are subject to change.

About Abbott

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 113,000 colleagues serve people in more than 160 countries.

ABOUT HACKENSACK MERIDIAN JERSEY SHORE UNIVERSITY MEDICAL CENTER

Located in Neptune, N.J., Hackensack Meridian Jersey Shore University Medical Center is a not-for-profit teaching hospital and the only Level I Adult and Level II Pediatric Trauma Center in Monmouth and Ocean counties.  It is home to K. Hovnanian Children’s Hospital – the first children’s hospital in these counties.  With more than 1,200 physicians and dental staff in 60 specialty areas, Jersey Shore University Medical Center’s (JSUMC) team provides high-quality care in a patient-centered, environmentally-friendly setting.

The team’s commitment to excellence has earned JSUMC numerous quality accolades, including being named the #7 best hospital in New Jersey, #23 in the NY metro area and high performing in nine specialties, procedures and conditions by U.S. News & World Report for 2021-2022.  JSUMC has also received national recognitions demonstrating clinical quality from Healthgrades, including America’s 250 Best Hospitals (2021, 2022), 100 Best Hospitals for Stroke Care (2020-2022), 100 Best for Gastrointestinal Surgery (2022) and Patient Safety Excellence Awards (2020, 2021) as well as Excellence Awards in Neurosciences (2020-2022), Cranial Neurosurgery (2022) and Bariatric Surgery (2021, 2022).  Jersey Shore’s programs and services continue to receive numerous national recognitions, including designation as high-performing in cardiac (including American College of Cardiology’s HeartCARE Center, National Distinction of Excellence recognition in 2021), stroke, surgical and oncology services. 

The medical center’s clinical research program and longstanding commitment to medical education is evident through an affiliation with Hackensack Meridian School of Medicine and an affiliation with St. George’s University School of Medicine.  JSUMC serves as an academic center dedicated to advancing medical knowledge, training future physicians and providing the community with access to promising medical breakthroughs.

JSUMC’s HOPE Tower, a $265 million, 10-story medical office building, provides a healing outpatient experience.  Guided by a patient-centered approach towards care, and informed by the latest medical breakthroughs, HOPE Tower includes advanced imaging services, a clinical academic center, innovative simulation laboratory, state-of-the-art amphitheater, specialty physician offices, a nine-level parking garage, and a 58,000 square foot cancer facility.  The cancer facility features a range of comprehensive treatment options, including surgical specialties, medical oncology, and the most advanced radiation therapy and minimally invasive interventional therapies.  Nurse navigators guide patients through every step and provide an extra layer of support and coordination.  For information, visit HackensackMeridianHealth.org