Clinical trial results showing the effectiveness of a new approach for optimizing cardiac devices will be published in this month’s issue of the peer-reviewed Journal of Cardiovascular Electrophysiology (JCE).The study found that QuickOpt Timing Cycle Optimization from St. Jude Medical (St. Paul, Minnesota) is equivalent to traditional echocardiography (echo) in optimizing implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds), but requires less time and effort.
Because heart disease is different for each patient, customizing device settings for each patient — “optimization” — enhances device performance so that it works in the most efficient manner. However, St. Jude says that few patients receive the full benefit of their devices because echo — the present clinical standard — can be expensive and time-consuming.
In the study, QuickOpt correlated to echo procedures for determining optimal conduction delays more than 96% of the time for both atrial-ventricular (AV) timing and ventricular-ventricular (VV) timing. The study endpoint required a correlation greater than 90% to achieve statistical significance. QuickOpt procedures were completed within two minutes, while echo optimization typically takes 30 to 120 minutes and requires manual interpretation by a technician.
The study authors concluded: “A strong correlation between the IEGM (QuickOpt Timing Cycle Optimization) method and echocardiogram optimization was consistently observed for all analyses. It can be performed safely in the office during routine follow-up in less than two minutes using the programmer.”
St. Jude says it designed QuickOpt as an easy and practical method for making the benefits of optimization more accessible to patients. In previous studies, 80% of heart failure and ICD patients have benefited from timing cycle optimization.
“As an easy, practical and effective alternative to traditional optimization methods, the QuickOpt method allows more patients access to the benefits of optimization,” said Michael Coyle, president of St. Jude’s Cardiac Rhythm Management Division.
James Baker II, MD, of The Heart Group (Nashville, Tennessee) and an investigator in the QuickOpt clinical trial, authored the study, titled “Acute Evaluation of Programmer-Guided AV/PV and VV Delay Optimization Comparing an IEGM Method and Echocardiogram for Cardiac Resynchronization Therapy in Heart Failure Patients and Dual-Chamber ICD Implants.” Initial results from the QuickOpt trial, conducted under an FDA investigational device exemption, were presented at the Cardiostim 2006 international medical meeting in Nice, France.
With the push of a button, QuickOpt provides recommended programming values on a results screen. Clinicians can accept or modify the recommended results and program the device accordingly. Available worldwide on St. Jude’s Merlin Patient Care System and 3510 programmer, the QuickOpt feature is compatible with all St. Jude CRT-D and dual-chamber ICDs, including those previously implanted prior to the availability of this feature.