A Medical Device Daily
Sorin Group ’s (Milan, Italy) Cardiac Rhythm Management business unit has reported the initiation of the OPTION (Optimal Antitachycardia Therapy in ICD Patients without Pacing Indication) clinical study in Europe.
The primary objective of the study is to demonstrate that implantable dual-chamber cardioverter defibrillators (ICDs) have greater efficacy than single-chamber ICDs in reducing inappropriate shock delivery and have the same efficacy in reducing all causes of patient mortality and hospitalizations due to cardiovascular events.
The multicenter, two-arm randomized OPTION study aims to demonstrate that patients implanted with dual-chamber ICDs incorporating features such as optimal dual-chamber arrhythmia detection, a pacing mode that minimizes ventricular pacing and a slow ventricular tachycardia zone, have better outcomes in terms of inappropriate shock delivery, patient mortality and hospitalizations than patients with single-chamber devices.
The first patients who were enrolled in the OPTION study in Germany, Portugal and Italy all were implanted with Sorin’s Ovatio dual-chamber ICDs. Ovatio ICDs feature the PARAD+arrhythmia detection algorithm, AAIsafeR mode, that limits ventricular pacing and a slow ventricular tachyarrhythmia (VT) zone.
Patients included in the study are randomized to either single-chamber ICD therapy following standard clinical practice with an active monitoring zone to allow ventricular arrhythmia documentation, or to dual-chamber detection and therapy in the slow VT zone with AAIsafeR switched on.
The principal study investigator, Christof Kolb, MD, of Deutsches Herzzentrum (Munich, Germany), said, ”We are confident that OPTION will significantly help us assess whether dual-chamber ICD therapy gives clinical benefit to patients without a pacing indication. Ovatio DR innovative features and the design of the trial will enable us to investigate the impact of ICD therapy on the full range of ventricular tachyarrhythmias, including slow VTs, in combination with pacing backup in patients with impaired left ventricular function to avoid unnecessary ventricular stimulation. We also expect that the results of OPTION will help us in better selecting ICD candidates.”
Another objective of the study is to determine how to best identify patients who could benefit from ICD therapy using Sorin Group’s “T-variability” risk stratification method, a noninvasive Holter-based test that analyzes micro-volt variations which are linked to the development of life-threatening tachyarrhythmias.
Patient recruitment will be completed in 18 months. A follow-up phase of 27 months is scheduled after enrollment to allow monitoring of the development of atrial fibrillation and congestive heart failure.
The OPTION study will enroll 450 patients in Europe, Canada and the U.S. Interim results will be published every 12 months.
Andre-Michel Ballester, president of Sorin Group Cardiac Rhythm Management, said, “As pioneers in dual-chamber defibrillation therapy — ELA Medical (Arvada, Colorado) implanted the world’s first dual chamber ICD back in 1995 — Sorin Group takes it to heart to constantly demonstrate the clinical benefits of its innovative CRM technologies through upstream research as well as through post-release clinical studies.”
Compression therapy market seen growing
Compression therapy has been successfully used in Europe for more than a century and, according to Frost & Sullivan (F&S; London), the European markets for such therapy earned revenues of $205.8 million in 2005 and may reach $366 million in 2012.
F&S said compression therapy is proving to be the best treatment option for venous stasis ulcers and also is used as a preventive measure in the occurrence of deep vein thrombosis (DVT).
“Compression therapy is the treatment of choice for venous ulcers and all venous ailments,” notes Frost & Sullivan research analyst Kezia Jasper. “With a rise in lifestyle-related diseases such as diabetes and obesity, the increased adoption of compression therapy products is inevitable.”
Dietary habits and lack of exercise are contributing increasingly to the prevalence of obesity and diabetes, often resulting in venous and diabetic ulcers. In addition, there is a rise in awareness among individuals about DVT, which is leading to an increase in demand for compression hosiery.
The growing aging population in Europe is yet another factor influencing the rise in the occurrence of venous stasis ulcers. Underpinned by these factors, demand for compression therapy products is expected to escalate, Jasper said.
F&S said the markets are experiencing a shift from conventional compression therapeutics such as static compression therapy to new, innovative products, with dynamic compression therapy growing in significance.
With growing awareness among individuals of the need to prevent DVT, dynamic compression products such as pneumatic compression pumps are poised for growth.
Jasper said preferences have also have shifted from compression bandages to compression hosiery due to the comfort and ease of use of such products.
She said, however, that awareness of the advantages of dynamic compression products among physicians and individuals is low. And healthcare providers do not reimburse for dynamic compression products.
“Awareness among the physicians regarding the efficacy of dynamic compression products is low,” said Jasper. “This is primarily due to the lack of substantial clinical data to support the application of these products. In most cases, insurance payers and the government do not reimburse dynamic compression therapeutic devices and in the absence of reimbursement, patients are unwilling to spend on such treatment.”