NEW YORK, N.Y. — June 27, 2025 — An 8-year HonorHealth Research Institute clinical trial, using non-surgical techniques, showed 86% of patients with a type of usually fatal low blood pressure known as 'structural shock' survived at least 3 months, while 73% survived at least 6 months, according to a study presented here at a major heart convention.
"That's a spectacular improvement. This appears to be a monumental step forward," said David G. Rizik, M.D., head of the Scottsdale, Ariz.-based Research Institute's Cardiovascular Research Division.
Dr. Rizik presented the study's findings today at New York Valves 2025: The Structural Heart Summitheld at New York's Jacob K. Javits Convention Center. In only its second year, New York Valves is already the world's premier meeting of structural heart disease, which refers to conditions affecting the heart's valves, walls, chambers and muscles.
While ultra-low blood pressure, or cardiogenic shock, is often caused by a heart attack due to blockages in the arteries that feed the heart muscle, there is a growing recognition that this condition is also caused by structural shock, which usually involves damage to two major heart valves:
- The mitral valve, which controls oxygenated blood flow from the lungs to the heart's left ventricle, the largest and most powerful of the heart's four chambers;
- The aortic valve, which controls blood flow from the left ventricle to the body's circulatory system.
"Most of these patients are not surgical candidates. These are patients who come into our emergency departments in what is referred to as 'cardiogenic shock.' These patients are generally too sick to have an operation (open-heart surgery) to replace the mitral valve," said Dr. Rizik, lead author of a paper, Mitral Transcatheter Edge-to-Edge Repair and Mandatory Mechanical Circulatory Support in Patients With Structural Shock , (doi: 10.1016/j.jscai.2025.102626) published in the Journal of the Society for Cardiovascular Angiography & Interventions (JSCAI).
Techniques pioneered at HonorHealth
Instead, structural shock patients at HonorHealth were diverted to the Institute's cardiovascular catheterization laboratory, where specialists — using devices guided through large blood vessels to enter the heart — performed two procedures:
- Patients' mitral valves were non-surgically repaired with a type of clip, thereby preventing blood from leaking, or regurgitating, back into the lungs;
- Patients were non-surgically implanted with a motorized impeller that sucked blood from the left ventricle and pushed it forward into the body through the aorta, the body's central artery.
Dr. Rizik said that, on average, more than 90 percent of cardiogenic shock patients do not survive.
"This is a brand new area of clinical investigation," he said, adding that the success of the HonorHealth clinical trial resulted from an unprecedented collaboration of heart specialists at the Institute, including cardiologists, cardiovascular surgeons, and specialists in imaging, critical care and intensive care.
"This represents one of the largest single-center prospective experiences examining transcatheter edge-to-edge repair in this high-risk population," according to the paper published in JSCAI.
Larger clinical trial sought
Dr. Rizik plans to build on the initial study of 30 cases by working with other medical centers to refine non-surgical techniques through a larger clinical trial involving hundreds of patients.
Structural shock can be caused in younger patients from genetic susceptibility, and in older patients from progressively worsening valves and chronic damage to the heart muscle.
New York Valves 2025 features live-case demonstrations, interactive debates, and hands-on training for professionals in the field, including interventional cardiologists, cardiac surgeons, clinical cardiologists, cardiac imagers, heart failure specialists, catheter lab professionals and nurses.
