A fresh and new approach to treating heart failure: The cardio-respiratory assist device. A first in human study.

Introduction: Hemodynamic congestion is governed by inflow from the RV and drainage through the LV. However, ventricular functions are oppositely affected by pleural pressure and breathing. We suggest that subtle adjustment to the cardiac rhythm in synchronization with respiratory dynamics can alleviate hemodynamic congestion, facilitate lung fluid clearance, and enhance patient congestion scores.

Method: The innovative pacing strategy shifts a few heartbeats from low to high intrathoracic pressure, thereby decreasing the RV preload and LV transmural pressure during these heartbeats, ultimately enhancing LV stroke-volume relative to RV stroke-volume. This technology has been validated in preclinical studies using sheep models of acute heart failure (HF, induced via acute myocardial infarction) and chronic HF (via intracoronary microsphere injection). A first-in-human result, during RHC procedure, is now being presented. Measurements included RV output via thermodilution, LV output via Fick’s principle (SvO₂), PAP, tidal volume, and respiratory rate.

Result: A congested HF class III patient with ischemic dilated cardiomyopathy, an EF of 25%, a cardiac index of 1.9 L/min/m² and an implanted CRT-D underwent an RHC procedure. At the end of the procedure, and following 5 minutes of baseline recordings, the patient was paced utilizing the suggested method, for 10 minutes. Consistent with preclinical studies, opposite effects of the unique pacing on RV and LV outputs were observed; LV output increased by 6.7%, while RV output decreased by 12.4%. End-diastolic PAP was reduced from 22.1 to 20.4 mmHg. The patient reported complete resolution of dyspnea. Additionally, respiratory rate decreased, and tidal volume increased significantly, from 396±48 mL at baseline to 611±47 mL, suggesting improvement in lung compliance.

Conclusion: The technology was demonstrated to be safe and imperceptible to the patient. It can reduce congestion by reducing pulmonary inflow and decreasing LV workload. Additional data from one to two patients is anticipated by the conference.