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At the forefront of electrophysiology innovation, Pasquale Santangeli, MD, PhD, Director of the ventricular tachycardia (VT) program in the Cardiac Electrophysiology and Pacing Section of Cardiovascular Medicine, is reshaping how complex cardiac electrophysiology procedures are performed. His work on a purpose-built RF microcatheter simplifies percutaneous epicardial access, making it safer, faster, and more reproducible. This technology reflects Cleveland Clinic’s commitment to expanding access to complex care through minimally invasive innovation and is poised to redefine standards in electrophysiology.
Innovating Epicardial Access for Safer, Faster Procedures
Epicardial access is essential for treating arrhythmias originating from the heart’s outer surface, yet it remains one of the most technically demanding procedures in electrophysiology. “To map arrhythmias with foci from the outside surface of the heart, we need to advance a needle in a virtual space called the pericardial space,” explains Dr. Santangeli. “With the technique we pioneered, we insufflate CO₂ to separate the space and give more anatomical clearance to the physician. You can clearly see the separation of the pericardial space on fluoroscopy, so it becomes safer and reproducible across different physicians”.
This approach significantly reduces the risk of complications, particularly inadvertent puncture of the ventricular wall or epicardial coronary vessels. “We already have data showing that you can abolish the most common complications just by augmenting the space,” he adds. “The needle has less chance to poke through the heart”.
The RF microcatheter combines radiofrequency energy for controlled right atrial appendage microperforation and CO₂ pericardial insufflation to gently and precisely create a working space in the pericardial cavity. Designed for compatibility with standard imaging tools like fluoroscopy and ultrasound, it enhances traditional access techniques with greater safety and reproducibility.
A Unified Solution for Transeptal Access
In addition to epicardial access, Dr. Santangeli’s team is developing a single-device solution for transeptal access, a standard procedure for interventions like atrial fibrillation ablation, appendage closure and other structural heart interventions. “Right now, we use multiple dilators and sometimes balloon septoplasty. This device gains access and dilates the fossa ovalis to any desired size in one step, accommodating sheaths of any size,” he says. “It also incorporates an electrode at the tip, enabling fluoro-less procedures guided by intracardiac echo and mapping systems”.
This innovation streamlines workflow, reduces procedural steps, and minimizes fluoroscopy exposure, key benefits for both clinicians and patients.
Clinical Impact: Making Complex Care More Accessible
What excites Dr. Santangeli most is the potential to democratize access to care. “Epicardial access is only done in specific centers with high expertise. Even there, complication rates can reach 5-7%,” he notes. “This solution simplifies the technique and makes it more accessible to other centers. Patients may be able to access proper care closer to wherever they are”.
He emphasizes the broader implications: “Some patients don’t get treated or get undertreated because of the complexity of their condition. If we can eliminate some of that or minimize it, we can make care more accessible globally, with ideally standardized outcomes”.
Efficiency Gains and Workflow Transformation
The RF microcatheter dramatically improves workflow. “We published a 4-minute procedure duration using our method,” says Dr. Santangeli. “It’s not just about speed; it’s about safety and precision”.
This reduction in time and complexity allows more centers to perform epicardial procedures, expanding patient access to care and reducing operator fatigue.
Strategic Collaborations and Thought Leadership
The RF microcatheter invention was assisted by Samir Kapadia, MD, Chair of Cardiovascular Medicine. “Without Dr. Kapadia, it wouldn’t be possible. He gave the idea of using radiofrequency for microperforation, which is the key for safe and controlled access,” says Dr. Santangeli.
Dr. Santangeli’s work is gaining international attention. He has presented on this technique at the annual VT Symposium, at the Heart Rhythm Society Scientific Session and will present updated outcomes from 40 patients at the Latin American HRS in Buenos Aires this October. “There’s a lot of interest in the community,” he says.
Broader Impact: Shaping the Future of EP Innovation
While epicardial access remains a highly specialized procedure, Dr. Santangeli sees growth potential. “I see this like transeptal access in the ’90s, once only done in a few centers, now widely adopted. Ideally, we can get to that point with pericardial access,” he envisions.
The technology opens doors to future therapies, including epicardial pacing and appendage ligation. “We need a safe way to get there, and this has the potential,” he says. “Some patients don’t get treated because of the complexity. If we can minimize that, we can standardize outcomes globally”.
A New Era in Cardiac Access
Dr. Pasquale Santangeli’s innovations are transforming the field of electrophysiology and cementing his status as a thought leader in cardiac care. Through his work in epicardial and transeptal access, he is setting the stage for a new era of patient care that is safer, faster, and more accessible. His leadership is shaping the future of EP innovation, clinical trials, and industry partnerships, with far-reaching implications for global healthcare.
Learn more about how Cleveland Clinic Innovations is advancing electrophysiology through clinician-led invention.
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