French Doctor Performs First Left Bundle Branch Area Pacing Implant

EBR Systems Inc., developer of the world’s only wireless cardiac pacing system for heart failure, announced that Professor Pascal Defaye, head of Rhythmology and Cardiac Stimulation Unit, CHU de Grenoble-Alpes, France, performed the world’s first successful Leadless Left Bundle Branch Area Pacing (LBBAP) implant performed utilizing the WiSE CRT System.
 
LBBAP pacing has been proposed as a strategy to achieve physiological pacing by utilizing the heart’s native conduction system, allowing faster left ventricular activation time.¹ LBBAP has potential applications in both traditional bradycardia pacing and as an alternative approach to Cardiac Resynchronization Therapy (CRT).² Until now, LBBAP has required use of a conventional pacing lead, driven deep into the ventricular septum, which can be technically challenging.³
 
“This implant marks an important milestone in the approach to physiological conduction system pacing,” said John McCutcheon, president and CEO at EBR Systems. “As the Left Bundle Branch is located sub-endocardially on the left ventricular septum, the WiSE CRT System is the only leadless pacing technology able to achieve LBBAP.”
 
Heart failure is a serious condition in which the heart is unable to pump enough blood to meet the body’s demands. A progressive, debilitating disease, heart failure often occurs when electrical signals within the heart are disrupted, causing the heart’s ventricles to beat in an uncoordinated or unsynchronized pattern, which in turn enlarges the left ventricle and makes the heart less efficient.
 
Without therapy, people with heart failure deteriorate and may eventually die of the condition. Cardiac resynchronization therapy offers a proven treatment that improves symptoms and reduces hospitalizations and mortality^4,5 by electrically stimulating the heart. Also referred to as biventricular pacing, CRT uses wire leads to synchronize the left and the right ventricles so that the two chambers beat together, thereby improving the heart’s efficiency. Approximately 200,000 patients are treated worldwide each year with traditional CRT and about 155,000 of them are in the United States.⁶

EBR Systems’ WiSE CRT System is the world’s only wireless, endocardial (inside the heart) pacing system in clinical use for stimulating the heart’s left ventricle. This has long been a goal of cardiac pacing companies since internal stimulation of the left ventricle is thought to be a potentially superior, more anatomically correct pacing location. WiSE Technology enables cardiac pacing of the left ventricle with a novel cardiac implant that is roughly the size of a large grain of rice. The need for a pacing wire on the outside of the heart’s left ventricle—and the attendant problems—are potentially eliminated.

Professor Defaye commented, “We were excited to be involved in the use of the WiSE CRT technology for LBBAP for the first time. Leadless LBBAP has the potential to provide superior resynchronization versus conventional CRT in select patients. We look forward to building on this clinical experience.”
 
The WiSE CRT System is an investigational device and is not currently available for sale in the United States.
 
Silicon Valley-based EBR Systems is dedicated to superior treatment of cardiac rhythm disease by providing more physiologically effective stimulation through wireless cardiac pacing. The company’s patented proprietary Wireless Stimulation Endocardially (WiSE) technology was developed to eliminate the need for cardiac pacing leads, historically the major source of complications and reliability issues in cardiac rhythm disease management. The company’s initial product is designed to eliminate the need for coronary sinus leads to stimulate the left ventricle in heart failure patients requiring CRT. Future products will address wireless endocardial stimulation for bradycardia and other non-cardiac indications. EBR Systems is backed by respected private equity investors including M.H. Carnegie & Co., Brandon Capital Partners, Split Rock Partners, Ascension Ventures and Emergent Medical Partners.

References 
¹ Zhang W, Huang J, Qi Y, et al. Cardiac Resynchronization Therapy by Left Bundle Branch Area Pacing in Patients with Heart Failure and Left Bundle Branch Block. Heart Rhythm. 2019; 16(12):1783-1790
² Padala SK and Ellenbogen KA. Left Bundle Branch Pacing is the Best Approach to Physiological Pacing. Heart Rhythm O2. 2020; 1(1):59-67.
³ Li X, Li H, Ma W, et al. Permanent Left Bundle Branch Area Pacing for Atrioventricular Block: Feasibility, Safety, and Acute Effect. Heart Rhythm. 2019;16:1766-1773.
⁴ McAlister FA, Ezekowitz J, Hooton, N, et al. Cardiac Resynchronization Therapy for Patients with Left Ventricular Systolic Dysfunction: A Systematic Review. JAMA. 2007; 297(22): 2502-14.
⁵ Abraham WT, Fisher WG, Smith AL, et al. Cardiac Resynchronization in Chronic Heart Failure. N Engl J Med. 2002; 346: 1845-53.
⁶ JP Morgan, Cardiac Rhythm Management (CRM) Market Model, August, 2017, Michael Weinstein