Hemodynamic Effects of AVIM Therapy for Hypertension Analyzed in Pressure-Volume Loop Study

August 26, 2025—Orchestra BioMed Holdings, Inc. announced the publication of data from a pressure-volume (PV) loop study demonstrating favorable hemodynamic effects of atrioventricular interval modulation (AVIM) therapy in pacemaker-indicated patients with uncontrolled hypertension. The study was published by Milan Chovanec, MD, et al in JACC: Clinical Electrophysiology.

According to the company, the investigators reported the findings from an invasive PV loop analysis in 16 hypertensive pacemaker-indicated patients, as well as noninvasive PV loop analysis from a subgroup of patients (n = 32) from the MODERATO II study who received chronically administered AVIM therapy.

As summarized in Orchestra BioMed’s press release, the analyses demonstrated the following:

• AVIM therapy reduced systolic blood pressure (SBP) acutely by decreasing cardiac preload and effective arterial elastance unrelated to pacing lead location, while also improving left ventricular (LV) end-diastolic and end-systolic volumes.
• Chronically administered AVIM therapy demonstrated sustained reductions in SBP and end-diastolic volume, indicative of favorable reverse LV remodeling.
• Consistently favorable hemodynamic effects using traditional right ventricular and conduction system pacing lead placements.

Study investigator Daniel Burkhoff, MD, Director, Heart Failure, Hemodynamics, and MCS Research, Cardiovascular Research Foundation in New York, New York, discussed the findings in the company’s press release.

“Pressure-volume loop analysis is regarded as the gold standard for assessing systolic and diastolic function as well as reverse remodeling,” stated Dr. Burkhoff. “These results provide powerful insights on the impact of AVIM therapy to both decrease blood pressure and favorably impact ventricular end-diastolic volume without compromising cardiac output or increasing workload. Notably, these favorable effects were observed consistently and with different pacing lead locations, demonstrating the versatility of AVIM therapy.”

Dr. Burkhoff continued, “Publication of these data in a prestigious peer-reviewed journal such as JACC: Clinical Electrophysiology provides further validation from the clinical community reinforcing the therapeutic rationale behind AVIM therapy and further highlighting its potential to deliver differentiated clinical benefit for patients with uncontrolled hypertension.”

AVIM therapy is currently being evaluated in the BACKBEAT global pivotal study, which Orchestra BioMed is conducting in collaboration with Medtronic, to support potential future global regulatory approvals and commercialization of AVIM therapy-enabled devices, noted the company.