Implantable stretchable sensors and soft robotic assist devices for monitoring and therapy of heart failure

Dr. Nikolay V. Vasilyev

[Abstract]

Heart failure (HF) represents a significant healthcare burden worldwide. In the United States, with a prevalence of 5.7 million, HF costs the nation an estimated $30.7 billion each year. About half of people who develop HF die within 5 years of diagnosis. In China, the prevalence of HF reaches 0.9 %, 0.7% in men and 1.0% in women, and will be dramatically increasing with aging of the population.

Continuous monitoring of cardiac function in HF using implantable electronic devices suggests reductions in mortality, all-cause hospitalizations and HF related hospitalizations. However, most of the current monitoring approaches aim for collecting the data (heart rate, pressure, oxygen saturation, metabolites) that are derivative representations of the primary – mechanical pumping – function of the heart.

Current therapy for end-stage HF, when medical management options have been exhausted, includes heart, lung or heart-lung transplantation, or mechanical circulatory support when a donor organ is not available. Several ventricular assist devices (VADs) provide short and long-term mechanical circulatory support for either left or right ventricles, or both. The ventricles have a complex geometry and contraction pattern that involves coordinated motion of the ventricular free walls and the ventricular septum. Current VAD designs do not address these anatomic and physiologic features of the ventricles, as the VADs are designed as pumps that unload the target ventricle by rerouting blood through an artificial circuit. Moreover, blood contact with the artificial circuit necessitates permanent anticoagulation and predisposes patients to bleeding and thromboembolic complications.

We have designed 1) implantable stretchable sensors that continuously acquire myocardial strain data and 2) soft robotic VADs (SR-VADs) with ventricular septal bracing as innovative approaches to continuously monitor ventricular function and to assist native ventricular contraction in end-stage HF. We demonstrated proof of concept in large animal studies by showing that functional prototypes can be safely and rapidly implanted on a beating heart and function for several hours. Future directions include designing sensors that capture multiaxial strain signal, manufacturing soft actuators that fully mimic ventricular motion, incorporating sensors for organ-in-the-loop control and validating the approach in longer-term studies.

[Biography]

Nikolay V. Vasilyev graduated from Sechenov First Moscow State Medical University. He completed his residency and fellowship training in cardiovascular surgery at Bakoulev Center for Cardiovascular Surgery in Moscow, and his research fellowship at the Cleveland Clinic, Cleveland, Ohio, USA. Dr. Vasilyev currently serves as a Staff Scientist at the Department of Cardiac Surgery at Boston Children’s Hospital and as an Assistant Professor of Surgery at the Division of Surgery at Harvard Medical School. His research has been focused on development of image-guided beating-heart cardiovascular interventions and cardiac surgical robotics. This includes clinically driven device design, development of imaging techniques and image processing, computer modeling and simulation. To date Dr. Vasilyev has published over sixty peer-reviewed papers, five book chapters and received four patents, with four more applications are pending. He is a member of the European Association of Cardiothoracic Surgery, where he served on the International Co-Operation Committee, and a member of the American Heart Association, American Society for Artificial Internal Organs and the International Society for Heart and Lung Transplantation. Dr. Vasilyev is a co-founder and Past President of the Russian-American Science Association. He is a Co-Founder and a Director of a start-up company Nido Surgical Inc.