News | Pacemakers | November 13, 2019

Wireless and Leadless Pacemaker Being Developed by Texas Heart Institute With Federal Grant

Co-principal investigator professor Aydin Babakhani at the UCLA Integrated Sensor Laboratory holds an earlier version of the prototype leadless, wireless amnd batteryless pacemaker. Photo Credit: Cody Duty, Texas Medical Center.

Co-principal investigator professor Aydin Babakhani at the UCLA Integrated Sensor Laboratory holds an earlier version of the prototype leadless, wireless and battery-less pacemaker. Photo Credit: Cody Duty, Texas Medical Center.

Mehdi Razavi, M.D., sharing the history of the pacemaker on display in the Texas Heart Institute Wallace Wilson Museum in Houston.

Mehdi Razavi, M.D., sharing the history of the pacemaker on display in the Texas Heart Institute Wallace Wilson Museum in Houston.

November 13, 2019 — Texas Heart Institute (THI) was awarded a prestigious four-year, $2.39 million grant from the National Institutes of Health (NIH) to explore further the development of a novel pacemaker system that is both leadless and wirelessly powered. 

Mehdi Razavi, M.D., director of electrophysiology clinical research and innovations at THI, co-principal investigator professor Aydin Babakhani at UCLA Integrated Sensors Laboratory (ISL), and co-principal investigator Behnaam Aazhang, Ph.D., J.S. Abercrombie Professor, electrical and computer engineering, Rice University, will lead the device development and research studies. The new pacemakers allow simultaneous pacing and sensing from multiple sites in the heart to help reduce the complications associated with the traditional pacemakers in use today.

“Current wireless pacemakers can be effective for patients with certain types of atrial fibrillation and in patients with a medical condition or anatomy that blocks access to the vessels where traditional pacemaker leads are attached," Razavi, said. "However, if the patient needs dual-chamber pacing, we are forced to use a traditional pacemaker with leads. Pacemaker wires called leads are prone to fracturing, dislodging and migrating away from the original location. Our technology could overcome this problem and make wireless, leadless, battery-less pacemakers available to these patients.” 

The pacing and sensing devices will be based on silicon-based integrated microchips that were built in Babakhani’s laboratory at UCLA. Post-doctoral scholar Hongming Lyu and Ph.D. students Hamed Rahmani and Yuxiang Lyu of Babakhani’s laboratory at UCLA designed the earlier version of the device. Babakhani’s laboratory has pushed the limits of miniaturization so that an entire pacemaker can fit inside a vein. The miniaturized pacemaker eliminates the need for bulky batteries as it receives energy and commands wirelessly through electromagnetic waves from an external controller. 

“One of the major challenges of this technology is maintaining the efficiency of wireless power transfer as the device becomes very small and the antenna becomes inefficient," explained Babakhani. "We have addressed this issue by significantly lowering the power consumption of the electronics used in the pacemaker, integrating all the elements on a single chip, and designing antennas that resonate strongly with the input circuitry of the pacing chips."

A Short History of Pacemakers 

Mehdi Razavi, M.D., sharing the history of the pacemaker on display in the Texas Heart Institute Wallace Wilson Museum in Houston.Pacemakers are used to treat slow heart rates (bradycardia). An American physiologist built the first device referred to as an "artificial pacemaker” in 1932. Powered by a spring-wound, hand-cranked motor, the device was dismissed as nothing more than a gadget and was met with opposition at a time when using technology to alter the natural course of life was highly controversial. Pacemaker advances exploded in the late 1950s and early 1960s with several landmark firsts, including pacemakers that were battery-operated and wearable, totally implantable and self-contained. New battery technology in the 1970s dramatically improved the lifespan of the pacemaker.

After decades of steady pacemaker improvements since the 1970s, a new era of explosive growth for the pacemaker could dramatically improve outcomes and quality of life for millions of people suffering from heart rhythm disorders.

Development of Leadless, Wireless Pacemakers

The Abbott Micra leadless, single chamber pacemaker.New leadless systems are now available, such as the Medtronic Micra, that can provide pacing to one chamber of the heart. However, pacing therapy is typically delivered to multiple chambers of the heart in a synchronized manner, and the bulky size and shape of the new leadless pacemakers do not allow for multi-chamber pacing. Miniature, battery-less devices are being tested in clinical trials, but these devices can only deliver effective therapy in combination with another pacemaker.

Razavi and the team overcome all of these challenges with their wireless, leadless, battery-less pacemaker design.

The pacemaker they are developing also will learn from the data it generates, identify patterns and make adjustments to enable constant optimal patient-specific therapy, according to THI research engineers Allison Post, Ph.D., and Mathews John.

“Our pacemaker is a diagnostic and treatment-delivering device with the ability to constantly read the heart’s electrical needs and self-correct or continuously adjust and recalibrate to deliver a unique pacing treatment, in real time, for each individual,” added Razavi.

 

Receiving Funding to Develop New Cardiovascular Technologies

Beginning with the first artificial heart implant by Dr. Cooley in 1969, THI has addressed significant research gaps and secured critical funding from the National Heart, Lung and Blood Institute (NHLBI) and other government and non-government sources. The NHLBI has been a substantial source of support for THI, stimulating discoveries and enabling the translation of these discoveries into clinical practice.

“THI has a long track record of receiving funding awards from the NIH that have resulted in significant device development and led to productive partnerships with industry,” according to Emerson Perin, M.D., Ph.D., Texas Heart Institute’s medical director.

“Arrhythmias can be devastating and difficult to manage in patients with multiple comorbidities and complicated cardiovascular conditions such as heart failure. Dr. Razavi’s pacemaker is highly innovative, and this transformational funding from the NIH underscores the importance and relevance of his work,” added James T. Willerson, M.D., FACC, Texas Heart Institute president emeritus.

Razavi will oversee the device development and all preclinical studies. Babakhani will oversee the development of the pacing and sensing nodes. Aazhang will supervise the development of the data-driven algorithm, and Joseph R Cavallaro, Ph.D., professor of electrical and computer engineering and director of the Center for Multimedia Communication, and Yingyan Lin, Ph.D., assistant professor, will each contribute to the design of the external controller that processes the signals.

Research reported in this publication is supported by the NHLBI under Award Number 1R01HL144683-01A1. The content is solely the responsibility of the authors and does not necessarily represent the official views of the NIH.

For more information: www.texasheart.org

 

Related Pacemaker Content:

New Pacemaker Technologies

CHLA/USC Team Designs Novel Micropacemaker

Safety, Performance of the World's Smallest Pacemaker Reinforced in Real-world Patients

VIDEO: Current State of Leadless Pacemaker Technology — Interview with Vivek Reddy, M.D.

Novel Mechanical Sensor in Medtronic Micra Transcatheter Pacing System Detects Atrial Contractions, Restores AV Synchrony

FDA Warns of Premature Battery Depletion in Some Medtronic Pacemakers

Artificial Intelligence Can Improve Emergency X-ray Identification of Pacemakers

VIDEO: Use of an Antibacterial Envelope to Reduce Infections for Pacemakers, ICDs

New Approaches to EP Lead Management

VIDEO: How to Implant the Micra Leadless Pacemaker

Related Content

HRS study finds Frequent Coffee Consumption Lowers Chance of Arrhythmias. #HRS #HRS20 Heartrhythm20
News | EP Lab | May 28, 2020
May 28, 2020 – A recent study revealed that drinking a couple of cups of coffee per day does not lead to a greater ri
he Actus AcQMap EP 3-D mapping catheter used  to speed  electromapping and procedure times.

he Actus AcQMap EP 3-D mapping catheter used  to speed  electromapping and procedure times.

News | EP Lab | May 20, 2020
May 20, 2020 — Acutus Medical and Biotronik announced a new alliance to provide a comprehensive portfolio of...
Thermedical, a developer of thermal-ablation medical systems to treat ventricular tachycardia (VT), announced that it has received Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA) for its Saline Enhanced Radiofrequency (SERF) Ablation system and Durablate catheter.
News | EP Lab | May 19, 2020
May 19, 2020 – Thermedical, a developer of thermal-ablation medical systems to treat ventricular tachycardia (VT), an
HRS presentations included BlueSync Evaluation study for Medtronic MyCareLink Heart mobile app and Micra TPS CED Study
News | EP Lab | May 14, 2020
May 14, 2020 – Medtronic announced results from late-breaking clinical trials evaluating the MyCareLink Heart mobile
Etripamil Nasal Spray Does Not Meet Primary Endpoint in Treating Supraventricular Tachycardia in the NODE-301 trial presented at Heart Rhythm 2020. #heartrhythm2020 #HRS2020
News | EP Lab | May 13, 2020
May 13, 2020 — The patient-administered nasal spray drug etripamil did not meet its primary endpoint in treating pati
Medtronic Cobalt and Crome ICD
News | EP Lab | May 12, 2020
May 12, 2020 — Medtronic has received U.S.
The CardioFocus HeartLight Excalibur Balloon X3 ablation system allows direct visualization of the laser ablation procedure, helping reduce use of X-ray angiography and reducing procedure time. FDA clears, approved, the HeartLight X3 Laser Ablation System to Treat Atrial Fibrillation.

The CardioFocus HeartLight Excalibur Balloon X3 ablation system allows direct visualization of the laser ablation procedure, helping reduce use of X-ray angiography and reducing procedure time.

News | EP Lab | May 12, 2020
May 12, 2020 — The U.S. Food and Drug Administration (FDA) has cleared the next-generation CardioFocus Inc.
EP lab photo from Philips Healthcare
News | EP Lab | April 30, 2020
May 1, 2020 — The Heart Rhythm Society (HRS) has created a COVID-19 Task Force to make recommendations related to edu
The European Heart Rhythm Association (EHRA) electrophysiology (EP) annual meeting cancelled due to coronavirus. #COVID19 #coronavirus #2019nCoV
Feature | EP Lab | March 10, 2020 | Dave Fornell, Editor
March 10, 2020 — Novel coronavirus (...
The U.S. Food and Drug Administration (FDA) cleared the Acutus Medical SuperMap, an addition to its AcQMap 3-D imaging and mapping system used to guide electrophysiology (EP) catheter ablation procedures. Adding the SuperMap mode to the AcQMap system enables users to visualize any atrial rhythm in less than three minutes. Rapidly mapping and re-mapping the whole heart chamber facilitates a new procedural workflow in EP ablation, making it practical to execute an iterative "map, ablate, re-map" approach.
News | EP Lab | March 05, 2020
March 5, 2020 — The U.S.