CircuLite updates on Synergy clinical trial progress
Updated clinical data related to CircuLite's Synergy miniature ventricular support system have been presented in two oral presentations and one poster session at the International Society for Heart and Lung Transplantation's annual meeting in Prague, Czech Republic. The Synergy system has also been implanted in its 51st patient in an ongoing CE mark trial.
Updated results presented from the ongoing CE mark trial for the Synergy system included significant improvements in haemodynamics, exercise capacity and quality of life in INTERMACS IV, V and VI heart failure patients. A second presentation described the induction of positive physical changes to the left ventricle with the Synergy system, including size reductions toward normalcy (reverse remodelling). These data came from a study conducted in a preclinical model of heart failure and from a comparative analysis of explanted hearts conducted at the time of heart transplantation. A poster presentation discussed preclinical data supporting the feasibility of bi-ventricular support with two Synergy pumps.
In an oral session, Professor Meyns presented an abstract entitled, "A New Treatment Option for INTERMACS Profile 4, 5 and 6 Patients with the Circulite Synergy System", which detailed an ongoing European study of patients receiving Synergy system support (data presented on 50 patients). In patients who underwent follow-up right heart catheterisation at a median of 13 weeks (n=28), cardiac index increased from 2.2 ± 0.5L/min/M2 to 2.7 ± 0.5L/min/M2 (p<0.001) and large reductions in capillary wedge pressure from 27.1 ± 9.6mmHg to 17.5 ± 6.2mmHg (p<0.001) were observed. In addition, with the current data available from the ongoing trial, significant increases in exercise tolerance, functional status and quality of life were observed.
Improvements made in the Synergy system used in the last 13 patients have significantly decreased the rate of overall severe adverse events (events per patient-years). No strokes or other episodes of neurologic dysfunction were reported in these last 13 patients. These data support the notion that the Synergy system may provide clinical benefits and, in clinical experience to-date, has a low adverse event profile that helps justify treating this less poor patient population.
Another abstract entitled, "Reverse Remodelling With the Use of the CircuLite Synergy Circulatory Assist System", examined preclinical models of chronic heart failure as well as 37 hearts at the time of explants in patients undergoing heart transplantation (19 without cardiac support, 13 supported by HeartMate II (Thoratec) and five by Synergy). Across both preclinical and clinical analyses, six weeks of partial ventricular unloading with the Synergy system induced remodelling of the left ventricle. Hearts supported by the Synergy system had significantly lower volumes and geometric distortion than those of chronically failing unsupported hearts, as well as normalisation of passive end-diastolic pressure-volume relationships. These data were also reflected in the clinical trial data, in which patients' cardiac indices increased over the duration of support, suggesting that reverse remodelling did occur. Additionally, one patient experienced myocardial recovery after 140 days support; the Synergy micro-pump was explanted and the patient is doing well.
A poster entitled, "Two CircuLite Pumps as Bi-Ventricular Assist Device (BVAD) in an Ovine Animal Model" looked at bi-ventricular support (simultaneous support of the left and right ventricles) with two Synergy system micro-pumps and showed it to be feasible and able to provide full haemodynamic support in a preclinical model. This approach holds promise for providing bi-ventricular partial support in humans and, in particular, for full support in small adults and children.
Synergy is a miniature ventricular support system that offers a potential minimally-invasive treatment option for patients with chronic heart failure who are not responding to standard medical care. The less-invasive implant procedure is intended to reduce the surgical risks associated with implant procedures that require cardiopulmonary bypass support. In addition, Synergy is intended to reduce symptoms of heart failure and associated re-hospitalisations, as well as to improve exercise tolerance and quality of life. A micro-pump circulates up to 4.25L of blood per minute, and is intended to reduce the heart's workload while improving blood flow to vital organs. Synergy supplements the heart's native pumping capacity and preserves its ability to respond to the patient's cardiac output demands. The system is surgically implanted using a mini-thoracotomy and the micro-pump is placed in a pacemaker-like pocket.