Posts Tagged ‘pacemaker’

Legacy of Innovation Continues at Emory with Successful Arrhythmia Clinical Trial

The device is weighs less than a small coin and is only a little longer than a U.S. nickel. Image credit: Medtronic

The device is weighs less than a small coin and is only a little longer than a U.S. nickel. Image credit: Medtronic

Last week, a clinical trial that Emory researchers participated in was presented at the 2015 American Heart Association Scientific Sessions. The presentation revealed that the world’s smallest, minimally invasive cardiac pacemaker — the Micra Transcatheter Pacing System (TPS) — was successfully implanted in nearly all of the patients participating in the international clinical trial. The study was also published in The New England Journal of Medicine.

The non-randomized clinical trial enrolled a total of 725 patients across 56 centers, including Emory. Results showed the Micra TPS, which is about the size of a large vitamin and weighs less than a small coin, was successfully implanted in 99.2 percent of all patients (719 of 725). The device also over exceeded its safety and effectiveness measures and approximately 96 percent of patients experienced no major complications, which is 51 percent fewer than the complication rate seen in patients with conventional pacing systems.

Emory Healthcare cardiologists were the first in Georgia, and among the first in the United States, to begin implanting the Micra TPS last year. Emory was the top enrolling U.S. site in the trial.

“We were pleased to participate in this important trial, as this will likely be the way pacemakers are implanted in the future,” says Emory site principle investigator Michael S. Lloyd, MD, associate professor of medicine, Emory University School of Medicine.

“The outstanding results are very encouraging and will allow us to continue to offer this novel device as a safe alternative to our patients.”

Dr. Lloyd, a cardiac electrophysiologist, implanted the first Micra TPS at Emory in April 2014 at Emory University Hospital. He says there are an estimated 3 million people living with pacemakers, and about 600,000 pacemakers are implanted in the world every year.

During the procedure, the tiny device — approximately one-tenth the size of a conventional pacemaker — is delivered through a catheter inserted in the femoral vein to the inside of the heart. Once positioned, it securely attaches to the endocardial tissue of the heart wall and sends electrical pulses to the heart through electrode tips whenever it senses an abnormal heart rhythm.

Unlike conventional pacemakers, the Micra TPS does not require the use of wires, known as “leads.” These leads, threaded through blood vessels to connect to the heart, are sometimes the source of serious medical complications such as infection and vein injury.

Another important difference between the new device and traditional pacemakers is that implantation of the Micra TPS does not require a surgical incision and the creation of a “pocket” under the skin. Conventional pacemakers require a more invasive surgery.

“By not creating a pocket and implanting a rigid device directly below the skin, it eliminates another potential source of complications and any visible sign of the device,” says cardiologist Mikhael El Chami, MD, associate professor of medicine, who is also implanting the Micra TPS device at Emory.

For more information on Micra TPS at Emory, please call 800-75-EMORY.

To see the full NEJM article, please click here. To view the original Emory News Center press release, click here.

About Emory’s Arrhythmia Treatment Program

Emory’s arrhythmia treatment program is one of the most comprehensive and innovative clinics for heart rhythm disorders in the country. Emory’s electrophysiologists have been pioneers in shaping arrhythmia treatment options for patients with arrhythmias, such as atrial fibrillation, as well as for those with congestive heart failure. As primary and principal investigators for many national clinical trials, Emory has participated in numerous atrial fibrillation (A-fib, AF) and atrial flutter (a-flutter) studies with multiple catheters and energy sources. We are the only center in Georgia participating in a trial that provides alternatives to blood thinners to prevent stroke in patients with A-fib. We also have ongoing clinical trials of new pacemakers, defibrillators, ablation catheters, as well as new ways to use existing devices to help patients.

Emory Offers State-of-the-Art Therapies for Heart Rhythm Disorders

heart rhythm therapyHeart rhythm disorders (arrhythmias) are common medical problems that affect millions of Americans each year. Treatments for arrhythmias vary from simple medications to specialized procedures depending on the needs of a particular patient. Fortunately, due to rapidly advancing technology, available therapies are quickly changing.

As one of the premier medical research centers in the Southeast, Emory offers some of the most cutting-edge treatments available for a wide variety of heart rhythm disorders. Highlighted below are just a few of these new advances:

Wireless pacemakers

The world’s smallest pacemakers are being implanted at Emory as part of an ongoing clinical trial. The Micra leadless pacemaker is an investigational device that is about one-tenth the size of a standard pacemaker. This device is approximately the length of a paperclip and round, like a capsule. This capsule contains all of the components of the pacemaker including the battery, and eliminates the need for the wire that is part of a standard pacemaker system.

One of the key benefits of the Micra pacemaker is that fact that it is implanted using a catheter through a vein in the front of the leg. The device is inserted directly into the heart. This process is generally quicker than a standard pacemaker procedure, and avoids the need for a surgical incision. Patients who have slow heart rates with weakness, lightheadedness, or fainting may be candidates for the Micra pacemaker clinical trial. Emory is the only center in Georgia that is participating in this trial.

Subcutaneous defibrillators

Defibrillators are devices that are designed to detect and treat life-threatening heart rhythm abnormalities. They are traditionally inserted under the skin in the patient’s shoulder, with a wire (or “lead”) that travels through a vein into the heart. While these devices have proven very effective, the presence of a defibrillator lead within the bloodstream may be associated with certain long-term complications. These may include infection or scarring of the blood vessel.

The subcutaneous defibrillator is a new type of device that is placed under the skin just like a standard defibrillator. However, this new device has a lead that travels just under the skin without having to be inserted through a blood vessel. This reduces the risks associated with infection.

Cryoablation for atrial fibrillation

Atrial fibrillation is the most common heart rhythm disorder, and can be treated in a variety of ways depending on the needs of the patient. One treatment option for this arrhythmia is catheter ablation. Traditionally, ablation for atrial fibrillation involves heating, or cauterizing, certain cells involved in the generation of atrial fibrillation. One new technique that has become available in the past several years is cryoablation. This therapy involves freezing cells with a super-cooled balloon that is positioned inside the heart with the use of a catheter. Cryoablation has the potential to be quicker than standard ablation, while having similar safety and effectiveness.

Ongoing clinical trials

Emory offers several clinical trials for patients who suffer from heart rhythm disorders. These trials represent opportunities to participate in the use of cutting-edge treatments that may not be available elsewhere. To learn more about ongoing heart rhythm clinical trials at Emory, please contact:

Emory University Hospital: Janice Parrott, 404-712-5592,
Emory University Hospital Midtown: Paige Smith, 404-686-7992,
Emory St. Joesph’s Hospital: Cindy Barnes, 678-843-6093,

About Dr. Hoskins

Michael Hoskins, MDMichael Hoskins, MD, is an assistant professor of medicine and electrophysiologist who practices primarily at Emory University Hospital. Dr. Hoskins received his medical degree from the Medical College of Wisconsin in Milwaukee, after which he completed his residency in internal medicine at Emory. He was chief resident in Internal Medicine from 2005 to 2006. He then completed fellowships in cardiology and electrophysiology, also at Emory, and has been practicing here since 2010. He specializes in treating cardiac arrhythmias, focusing on ablation of arrhythmias and implantation and management of pacemakers and defibrillators.

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Emory University Hospital Celebrates Pacemaker Clinic 20th Anniversary

Emory University Hospital Atlanta, GAThe Emory University Hospital Pacemaker/ICD Services Program was established in 1991 by Paul Walter, MD, and Nancy Romeiko, RN. Dr. Walter was the medical director and overseeing physician and Ms. Romeiko served as head nurse. In 20 short years, the Pacemaker Program at Emory has grown to employ nine nurses, a technician and full-time administrative staff.

The Pacemaker/ICD Services Program serves over 3,500 patients who are actively receiving device monitoring services, and it has cared for more than 12,000 patients in the last 20 years! Emory’s Pacemaker Program averages approximately 400 to 430 procedures per week, including monitoring services by phone or remote system, and office visits in The Emory Clinic or one of the Program’s five outlying sites (Snellville, Decatur, Conyers, Hiawassee and Toccoa) in addition to Emory University Hospital Clifton Road campus location.

The Pacemaker Program provides device evaluation and monitoring services for all types of pacemakers and implanted defibrillators, including the latest devices used for pacing in congestive heart failure patients.

Many thanks go to the physicians, nurses and staff who have dedicated their careers to providing the highest quality of patient- and family-centered care to our patients in this program.

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