New International Heart Failure Treatment Trial
Christchurch Patients & Clinicians Take Part In New International Heart Failure Treatment Trial
Five Christchurch patients have been successfully implanted with a new monitoring system for the treatment of congestive heart failure using an investigational device developed by an American company.
Dr Richard Troughton one of the trial’s principal investigators and a researcher at the Christchurch School of Medicine and Health Sciences said the project is at the ‘cutting edge’ of heart failure research and is a unique and exciting opportunity.
The study is being coordinated by a research fellow based at the School of Medicine Dr Jay Ritzema-Carter and the two Christchurch Hospital implanting electrophysiologists are Dr Iain Melton and Dr Ian Crozier.
Dr Troughton said the innovative development was the work of a Californian company Savacor Inc.
‘They have developed a monitoring system for the treatment of congestive heart failure – ‘Homeostasis 1 trial’. The trial is being conducted at four international sites of which Christchurch is one,’ he said. Christchurch has led the study, implanting the first of these devices in the world. “This is largely because of the excellent team we have working on the study.”
‘The first three patients have already reached the primary trial end point which is six weeks after implantation and they are all doing well with no major adverse cardiac or neurological impact,’ he added.
Dr Troughton said the implant is a sensor that allows the patient to directly monitor left atrial pressure. The implant’s readings are communicated with a handheld computer called a ‘patient advisory module’. The information is used to adjust the patient’s medications on a dose by dose basis according to their physician’s prescriptive instructions. This allows real time adjustment and dosing of medication similar to the way that diabetics adjust insulin dosage in response to home glucose monitoring. Left atrial pressure is a key measurement for predicting acute worsening of heart failure that leads to lung congestion and the need for urgent hospitalisation.
‘The device is implanted by a minimally invasive cardiac catheterisation procedure which is similar to a pacemaker insertion,’ he said. ‘We are very excited to be part of the initiation of this first human experience evaluating this unique heart failure system. Starting with the very first patient, we have gained new insight into the dynamic cardiac changes that occur on a daily basis in our patients. We are hopeful that real time monitoring will allow us to better treat our patients and to minimise complications such as recurrent hospitalisation, acute pulmonary edema and renal failure.’
Chief Executive and co-founder of the company Savacor which has developed the new implant system Neal Eigler said the early phase trial being conducted in New Zealand would help gather information necessary for larger-scale investigations. The international study’s Chair and Chief of Cardiology at Ohio State University Dr William Abraham said the number of patients contracting heart failure was expected to double within the next decade as baby boomers age and develop heart disease.