By a News Reporter-Staff News Editor at Health & Medicine Week -- Researchers detail new data in Cardiology. According to news reporting from Milan, Italy, by NewsRx journalists, research stated, "A new four-pole connector system (DF-4) for transvenous high-voltage implantable cardioverter defibrillators (ICD) is currently available in clinical practice. However, no clinical data demonstrating the safety and effectiveness of this complex electromechanical design is available."
The news correspondents obtained a quote from the research from Institute for Cancer Research and Treatment (IRCCS), "This study aims to test the safety and effectiveness of this newly designed system compared to the conventional DF-1 leads. During a 3-year period, 351 consecutive patients were implanted with DF-4 leads as part of an ICD or ICD-cardiac resynchronization therapy system. Patients were matched for age, sex, and follow-up with 154 patients implanted with a standard DF-1 lead. The primary outcome of the study was defibrillation lead failure, defined as the need for lead removal or capping. Operative, electrical, and safety data were obtained at implant and during postoperative follow-up. Implantation success rate in both groups was 100 %. A trend towards shorter procedure time was observed in the DF-4 group but the difference did not reach statistical significance. Handling characteristics of the DF-4 leads were graded better than those of DF-1 models. During a total follow-up of 8,130.5 lead-months, there were nine ICD-lead failures (four system erosion/infections and five electrical lead dysfunctions). The overall incidence of electrical lead failure was 0.64 vs. 0.97 per 100 lead-years, for DF-4 and DF-1 leads, respectively (P = 0.2)."
According to the news reporters, the research concluded: "This multi-center experience provides strong evidence that the feasibility and safety of this novel technology compare favorably with those of the conventional DF-1 leads."
For more information on this research see: First clinical experience with the new four-pole standard connector for high-voltage ICD leads. Early results of a multicenter comparison with conventional implant outcomes. Journal of Interventional Cardiac Electrophysiology, 2013;38(1):11-18. Journal of Interventional Cardiac Electrophysiology can be contacted at: Springer, Van Godewijckstraat 30, 3311 Gz Dordrecht, Netherlands. (Springer - www.springer.com; Journal of Interventional Cardiac Electrophysiology - www.springerlink.com/content/1383-875x/)
Our news journalists report that additional information may be obtained by contacting G.B. Forleo, Center Cardiol Monzino IRCCS, Cardiac Arrhythmia Res Center, Milan, Italy. Additional authors for this research include L. Di Biase, M. Mantica, G. Panattoni, M. Santamaria, Q. Parisi, D. Sergi, L.P. Papavasileiou, L. Santini, C. Tondo, A. Natale and F. Romeo (see also Cardiology).
Keywords for this news article include: Milan, Italy, Europe, Cardiology, Electronics, High Voltage
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