Abstract
Introduction: Conventional temporary pacemakers with percutaneous pacing leads limit patient mobility, create risks for infections, require removal procedures following completion of therapy and demand an additional collection of wired devices to monitor the status of the patient and to provide closed-loop operation. Recently reported wireless, bioresorbable pacemakers avoid the first set of disadvantages, but they must still be paired with conventional wired-based systems for cardiac monitoring, power delivery and control. Methods: We present a bioresorbable pacemaker that combines with a wirelessly networked collection of temporary, body-integrated devices to (1) power, control, and monitor processes of cardiac stimulation, (2) track cardiopulmonary status via comprehensive, multi-modal measurements, (3) provide patient-specific multi-haptic feedback on device and physiological status, and (4) support transient operation through bioresorption and gentle removal from the skin. Results: Data captured from various locations of the body yield detailed information of patient status, across various aspects of cardiopulmonary health and physical activity. The results define autonomous rate-adaptive pacing parameters to match metabolic demand via wireless powering of the bioresorbable module. Operation is possible over extended periods to match clinical needs, enabled by advanced mechanical designs and drug eluting configurations of the battery-free, bioresorbable pacemaker platform. Replacement of the cardiac module can occur in a manner that does not disrupt continuous pacing. The skin-interfaced devices can be easily peeled away for removal after patient recovery, due to their soft, flexible construction. Conclusions: We demonstrate for the first time that a bioresorbable pacemaker with transient closed-loop system is feasible in a clinically relevant, large animal and human whole heart model. Further improvements in this technology could open doors for out of hospital temporary pacing for varying periods of time, without the need for permanent hardware.
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