Grant Kim Shares His Views from the Data Showing the World's First Dual-Chamber Leadless Pacemaker Study Achieving All Three Primary Endpoints

Shots:

Grant started by highlighting the characteristics of the AVEIR DR leadless pacemaker and this pacemaker is an effective treatment for people with slower-than-normal heart rhythms
He discussed the AVEIR™ DR i2i™ IDE study's design and outcomes, which assessed the safety and performance of the world's first dual-chamber leadless pacemaker. The study effectively met all three primary safety and performance endpoints
The interview sheds light on how Abbott innovatively enhances its healthcare portfolio, with leading products in diagnostics, medical devices, nutritional and generic medicines

Smriti: Would you please highlight the characteristics of the AVEIR DR leadless pacemaker? In what ways would this dual-chamber leadless pacemaker be a more effective form of treatment for people with slower-than-normal heart rhythms?

Grant Kim: The AVEIR™ DR leadless pacemaker system is uniquely designed compared to traditional pacemakers and other leadless pacemakers on the market. The AVEIR ventricular and atrial leadless pacemakers are designed to provide real-time mapping capability so physicians can assess proper placement of the device before it is implanted. The AVEIR leadless pacemakers are designed for retrieval, should therapy needs change or if the device needs to be replaced in the future. The novel i2i™ (implant-to-implant) communication technology provides synchronized or coordinated cardiac pacing between both the atrial and ventricular leadless pacemakers based on the person's beat-to-beat clinical needs. The AVEIR system is modular, such that a single device can be implanted in a heart chamber initially, and the second pacemaker added to the other heart chamber in the future should the clinical need arise.

Smriti: Brief us about the study design and the objectives of the AVEIR dual-chamber (DR) i2i Investigational Device Exemption (IDE) study.

Grant Kim: The AVEIR DR i2i IDE study is the industry’s first prospective study designed to evaluate the safety and performance of the world’s first dual chamber leadless pacemaker system in the U.S., Canada, Europe, and Asia-Pacific. The objective of the AVEIR DR i2i IDE study was to demonstrate that the AVEIR DR leadless pacemaker system is safe and effective for people who experience a slower-than-normal or abnormal heart rate and may require a dual chamber pacemaker to help restore a more normal heart rate.

Smriti: Can you shed some light on the key findings obtained from the AVEIR DR i2i IDE study?

Grant Kim: The AVEIR DR i2i IDE study met its three prespecified primary endpoints for safety and performance through 3 months post-implant. The primary safety endpoint was met with over 90% of people being free from serious complications. The performance endpoint for the atrial leadless pacemaker was met with over 90% of people demonstrating acceptable pacing and sensing. The performance endpoint for the DR system was met with over 97% of people having successful atrio-ventricular synchrony, so that the upper and lower chamber were beating normally, despite different types of underlying slow heart rhythms.

Smriti: Can you shed some light on the technological advancements that enabled seamless communication between two leadless pacemakers, as demonstrated by the AVEIR DR i2i study?

Grant Kim: The novel, wireless communication between the two leadless pacemakers is based on a first-of-its-kind i2i technology which utilizes high-frequency pulses to relay messages via the naturally conductive characteristics of the body's blood between the two leadless pacemakers. This conductive communication is critical, because it uses far less battery current than inductive, radio frequency or Bluetooth® communication which are other alternatives used in implantable medical devices and traditional pacemakers. To support dual-chamber therapy, each implant communicates beat-to-beat with a paired, co-implanted device to provide synchronized or coordinated pacing based on a person’s clinical needs. The i2i technology was demonstrated in the AVEIR DR i2i study which showed an average atrio-ventricular (AV) synchrony of more than 95% in each of seven different postures and activity levels, demonstrating the system will function appropriately during everyday life activities.

Smriti: Please give our audience some insights into the advantages provided through the AVEIR DR leadless pacemaker over the conventional method of treating slower-than-normal heart rhythms.

Grant Kim: Unlike traditional pacemakers, the AVEIR DR leadless pacemakers, which are smaller than a AAA battery, are implanted directly into the heart through a minimally invasive procedure and eliminate the need for a device pocket in the chest and cardiac leads in the heart. This can reduce people's exposure to potential lead and infection-related complications and offer a less restrictive and shorter recovery period post-implant. It also allows people who need a pacemaker not to have a constant reminder of having a pacemaker that comes with a traditional pacemaker implanted in the chest.

Smriti: How has the presentation at the Heart Rhythm Society’s (HRS) Annual Meeting and the publication in The New England Journal of Medicine contributed to bringing AVEIR DR to the attention of patients with slower-than-normal heart rhythms?

Grant Kim: The results of the AVEIR DR i2i IDE study presented at HRS and published in NEJM has allowed us to share the safety and performance data mainly with the broader physician community. With the recent FDA approval, we anticipate that U.S. physicians will start having conversations with their patients on this new option available to them.

Smriti: What are the next steps for Abbott following the submission of the AVEIR DR leadless pacemakers for evaluation by the U.S. Food and Drug Administration (FDA)?

Grant Kim: It is estimated that 12.1 million people in the United States will have cardiac arrhythmias in 2030. The FDA recently approved the AVEIR DR leadless pacemaker system, which will significantly increase access to leadless pacing for millions of people across the U.S. AVEIR DR has been designed to address a critical need for people with slower-than-normal heart rhythms by introducing first-of-its-kind i2i technology that provides synchronized pacing based on a person’s clinical need.

Abbott is constantly innovating and committed to advancing treatments for people with cardiovascular disease so they can live life to the fullest. We are creating the future of healthcare through life-changing technologies and products that drive breakthroughs in prevention, diagnosis and treatment.

Image source: Canva

About the Author:

Dr. Grant Kim ‘

Dr. Grant Kim is the Divisional Vice President of Global Clinical Affairs for Cardiac Rhythm Management at Abbott. With over 16 years of experience in designing and executing clinical trials of which 11 years have been with Abbott, he led the pivotal clinical trials for Abbott’s AVEIR Leadless portfolio. Grant’s passion is to bring innovative medical device technology to fulfill the unmet needs of physicians and their patients.