Testimony of Dr. Jay G. Ronquillo
FDA Advisory Committee Meeting on Leadless Cardiac Pacemakers
Thank you very much for the opportunity to speak today. My name is Dr. Jay Ronquillo and I am speaking on behalf of the National Center for Health Research. I am a physician who trained at Massachusetts General Hospital, have two electrical engineering degrees from Cornell, a Master of Public Health from Harvard, and a master’s in biomedical informatics from Harvard Medical School. These are the perspectives I bring with me today. Our research center analyzes scientific and medical data and provides objective health information to patients, providers, and policy makers. We do not accept funding from the drug or medical device industry and I have no conflicts of interest.
Implantable cardiac pacemakers have played an important role in the clinical care of patients for decades. Leadless cardiac pacemakers represent a related but new technology with the potential to improve the lives of patients. However, it will be important to make sure that a high standard and evidence-based approach is used to ensure that the right balance exists between the risks and benefits of this new technology.
Leadless pacemakers demonstrate a different distribution in the rate and type of adverse events compared to traditional pacemakers. There seems to be lower rates for some complications (such as pneumothorax) or even the absence of other complications (like pocket-related hematomas, bleeding, and infection; or lead-related fracture or dislodgement). However, there are potentially higher rates of certain complications (such as right ventricular perforation with tamponade), and even the introduction of entirely new complications (such as femoral vascular access issues). In sum, there is a complex tradeoff of adverse events for these devices, and these tradeoffs need to be assessed in the context of how they impact patients relative to the traditional products currently on the market.
While the acute performance of leadless cardiac pacemakers is important, the intermediate and long-term performance of these devices requires significantly more data. We need to know more about novel complications, clinical outcomes, and adverse events, and how they overlap and compare with traditional pacemakers. For example, better data are needed on direct and indirect complications caused by encapsulation of the leadless pacemaker and how that possibly compares with lead encapsulation of traditional pacemakers. What are the potential differences involved with extraction, replacement, or co-implantation of both types of devices at the end of their mechanical reliability and battery life? Those are key questions regarding safety and effectiveness.
Post approval study design and surveillance will likely play an important role in the long-term success of leadless pacemakers. While a complete understanding or assessment of long-term performance may not be possible at the time of approval, any post approval study paradigm must be capable of filling those knowledge gaps in a timely manner. It is essential to clearly identify the most important factors from the physician and patient perspectives, and anticipate adverse outcomes before they significantly harm a patient’s life and quality of life.
In summary, leadless pacemakers have the potential to improve the care of patients with various cardiac rhythm disorders. However, this will require an understanding of how acute adverse events compare and contrast with those of traditional pacemakers. I encourage you to urge the FDA to require comprehensive data regarding the intermediate and long-term safety and effectiveness of leadless pacemakers. Post approval studies should clearly assess these diverse factors. They should provide context regarding the entire spectrum of safety and effectiveness in a way that enables physicians to make sound decisions, and that allows patients to fully and clearly understand the risks and benefits of this new technology.
Thank you again for the opportunity to speak today and for consideration of our views.