Texas Heart Institute (THI) has been awarded a prestigious four-year, $2.39 million grant from the National Institutes of Health (NIH) to explore further the development of a pacemaker system that is both leadless and wirelessly powered. Dr. Mehdi Razavi, director of Electrophysiology Clinical Research & Innovations at THI, co-PI prof. Aydin Babakhani at UCLA Integrated Sensors Laboratory (ISL), and co-Investigator prof. Behnaam Aazhang at Rice University Electrical and Computer Engineering will lead the device development and research studies.
Razavi will oversee the device development and all preclinical studies. Co-PI Babakhani will oversee the development of the pacing and sensing nodes. Aazhang will supervise the development of the data-driven algorithm, and Drs. Joseph R Cavallaro and Yingyan Lin will each contribute to the design of the external controller that processes the signals.
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. 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,” said Razavi, principal investigator of the project.
The pacing and sensing devices will be based on silicon-based integrated microchips that were built in Babakhani’s laboratory at UCLA. Postdoctoral 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. Dr. 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. 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,” Babakhani said.
The pacemaker will also learn from the data it generates, identify patterns, and make adjustments to enable constant optimal patient-specific therapy according to THI research engineers, Dr. Allison Post 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.
“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 Dr. James T. Willerson, Texas Heart Institute president emeritus.