A system is constructed for navigation feedback during an interventional cardiology procedure for Cardiac Resynchronization Therapy (CRT) by seeking out the location with low oxygen saturation, which coincidentally is the place for the implantation of leads to pace the heart. Heart failure affects 22 million people worldwide. In many of these patients, an abnormality in the heart's electrical conducting system causes the two ventricles to beat in an asynchronous fashion, greatly reducing their efficiency. CRT is a relatively new form of therapy for congestive heart failure, but has proven to reduce hospital visits and deaths due to Congestive Heart Failure, as well as improve the patient's quality of life. Interventional treatment is performed by implanting a left ventricle pacemaker lead into one of the coronary venous tributaries. The success of such implantation is highly dependent on the operator's skill, the tools available, and the coronary venous anatomy. Oxus Medical has invented a novel device that assists in locating the orifice of the coronary sinus by sensing characteristics of blood emerging from the coronary sinus into the right atrium. The percent oxygen saturation in the coronary sinus is among the lowest in the human body. The system utilizes a steerable catheter with an oxygen sensor that plugs into an oximeter system to display percent oxygen saturation. By sensing the oxygen concentration at the distal tip of the catheter and steering it towards a region of lower oxygen concentration, the location of the coronary sinus can be determined. Once the orifice of the coronary sinus is located, it can be cannulated to allow for the placement of a ventricular pacing lead. The idea has been proven by this group in an in-vivo model with 1st and 2nd generation catheter prototypes. The system will increase the safety profile and decrease the amount of time required to perform CRT, by providing a better and more precise method of locating the coronary sinus than visualization alone. This project will design a 3rd generation catheter, more suitable for human use, and will be tested in a canine model. This project will prepare for future use in human patients following safety, sterilization, and biocompatibility testing.
The Specific Aims are: 1) Create Third Generation steerable and sensing catheters for locating the coronary sinus, using custom developed oxygen saturation instrumentation. 2) Create a Portable Diagnostic and Monitoring System that will interface with the catheter, which will ultimately be needed for clinical trials and market release. 3) Verify in animal trials that the sensor can be steered, read, and guided by sensing the oxygen level and differentiate the levels of oxygen saturation between the right atrium and the coronary sinus. Prove that the coronary sinus may be located and cannulated with minimal fluoroscopy use.
More than 100,000 new patients each year with Congestive Heart Failure could benefit from a new technology (CRT) that coordinates the beating of their heart. Studies have shown that successful CRT procedures reduce hospitalization and deaths from Heart Failure as well as improve the quality of life for patients. Many of these patients are unable to be helped by CRT because their anatomy is difficult to navigate using current methods. The proposed research assists the physician implanting the new technology by directing the physician to the correct implant site. The goal is to make the procedure successful in more patients who otherwise have few options. Additional benefits include reducing the procedure time and reducing the amount of fluoroscopy (x-ray exposure) used since the guidance is in real-time.
