Large, Randomized Trial Demonstrates Excellent Shock Efficacy of BIOTRONIK Implantable Cardioverter-Defibrillators
BERLIN, Germany, September 04, 2015 – BIOTRONIK, a leading manufacturer of cardiovascular medical technology, today announced the publication of NORDIC ICD (NO Regular Defibrillation testing In Cardioverter-Defibrillator Implantation) trial results in the European Heart Journal. The BIOTRONIK-sponsored, randomized, controlled trial contributes to a growing body of clinical evidence suggesting that defibrillation (DF) testing during routine first implantable cardioverter-defibrillator (ICD) implantation on the left side does not lead to significant clinical benefits. Importantly, these results also demonstrate the exceptional shock efficacy of BIOTRONIK ICDs in a large, real-world population.
NORDIC ICD is a prospective, multi-center, international non-inferiority study. The trial tested whether shock efficacy in ICD patients is impaired without DF testing, which is normally done in order to verify detection of tachyarrhythmias and defibrillation efficacy at the time of implantation. Although DF testing has never been shown to improve survival, and is associated with longer, more complex implantation procedures requiring technical support and anesthesia, it is currently the standard of care in
many countries1.
1,077 real world patients with an ICD indication according to current ESC guidelines1—including single- and dual-chamber and cardiac resynchronization therapy devices (CRT-Ds)—were randomized into two groups, with (N=540) and without (N=537) DF testing. Patients were observed for at least 12 months through regular on-site visits and remotely via BIOTRONIK Home Monitoring®, a wireless, automatic remote monitoring technology available in BIOTRONIK ICDs. The primary end point was first shock efficacy to terminate episodes of true ventricular tachycardia (VT) or ventricular fibrillation (VF) during follow-up. The BIOTRONIK ICDs implanted demonstrated exceptionally high safety and efficacy for both study arms, as shown by the 97.1 percent rate of first shock efficacy in the no DF test group and 94.1 percent rate for the DF test group.
“Despite a lack of evidence supporting its usefulness, routine intraoperative DF testing has long been standard practice,” explained coordinating clinical investigator Dr. Dietmar Bänsch, University Hospital of Rostock, Germany. “Now the results of the NORDIC ICD trial, in concurrence with those of SIMPLE, another recent large, randomized study, reveal ICD implantation without DF testing to be non-inferior with regard to first shock efficacy2. Moreover, we did not find significant differences between the study groups regarding mortality and serious adverse events. Taken together, these results do not support the need for routine DF testing during first time ICD implantation on the left side, particularly for the modern, high-energy ICDs used in the NORDIC ICD trial.”
“We are gratified to see BIOTRONIK ICDs performing extraordinarily well in a large, randomized, real-world patient population,” commented Klaus Contzen, Director Clinical Affairs at BIOTRONIK. “This is demonstrated by the low rate of all-cause mortality, 8.2 percent without DF testing over a median follow-up time of 22.9 months, lower than that of other similarly sized ICD trials. Taken together with the very high first shock efficacy of 97.1% in the no DF test group, BIOTRONIK ICDs once again demonstrated excellent quality and safety.”
About BIOTRONIK
One of the world’s leading manufacturers of cardio- and endovascular medical devices, BIOTRONIK is headquartered in Berlin, Germany, and represented in over 100 countries by its global workforce of more than 5,600 employees. Several million patients have received BIOTRONIK implants designed to save and improve the quality of their lives, or have been treated with BIOTRONIK coronary and peripheral vascular intervention products. Since its development of the first German pacemaker in 1963, BIOTRONIK has engineered many innovations, including BIOTRONIK Home Monitoring; the world’s first 4 F-compatible 200 mm peripheral stent; Orsiro, the industry’s first hybrid drug-eluting stent; and the world’s first implantable cardioverter-defibrillators with ProMRI® technology.
For more information, visit: www.biotronik.com
References:
1 Bänsch D, et al. Europace. 2015, 17(1).
2 Healey J, et al. Lancet. 2015, 385(9970).
Contact:
Manuela Schildwächter
Senior Manager Communications & PR
BIOTRONIK SE & Co. KG
Woermannkehre 1
12359 Berlin
Tel. +49 30 68905 1414
Email: presse@biotronik.com