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

  • Giovanni B. Forleo
  • Luigi Di Biase
  • Massimo Mantica
  • Germana Panattoni
  • Matteo Santamaria
  • Quintino Parisi
  • Domenico Sergi
  • Lida P. Papavasileiou
  • Luca Santini
  • Claudio Tondo
  • Andrea Natale
  • Francesco Romeo
Article

DOI: 10.1007/s10840-013-9814-6

Cite this article as:
Forleo, G.B., Di Biase, L., Mantica, M. et al. J Interv Card Electrophysiol (2013) 38: 11. doi:10.1007/s10840-013-9814-6

Abstract

Purpose

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. This study aims to test the safety and effectiveness of this newly designed system compared to the conventional DF-1 leads.

Methods

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.

Results

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).

Conclusions

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.

Keywords

Connector Defibrillation lead DF-1 DF-4 Implantable cardioverter defibrillator Lead performance 

Copyright information

© Springer Science+Business Media New York 2013

Authors and Affiliations

  • Giovanni B. Forleo
    • 1
  • Luigi Di Biase
    • 2
    • 3
    • 4
    • 5
  • Massimo Mantica
    • 6
  • Germana Panattoni
    • 1
  • Matteo Santamaria
    • 7
  • Quintino Parisi
    • 7
  • Domenico Sergi
    • 1
  • Lida P. Papavasileiou
    • 8
  • Luca Santini
    • 1
  • Claudio Tondo
    • 9
  • Andrea Natale
    • 2
  • Francesco Romeo
    • 1
  1. 1.Department of Internal Medicine, Division of CardiologyUniversity of Rome “Tor Vergata”RomeItaly
  2. 2.Texas Cardiac Arrhythmia Institute at St. David’s Medical CenterAustinUSA
  3. 3.Department of CardiologyUniversity of FoggiaFoggiaItaly
  4. 4.Albert Einstein College of MedicineMontefiore HospitalNew YorkUSA
  5. 5.Department of Biomedical EngineeringUniversity of AustinAustinUSA
  6. 6.Arrhythmia and Electrophysiology CenterSt. Ambrogio Clinical InstituteMilanItaly
  7. 7.Cardiovascular Department, Center for High Technology Research and Education in Biomedical SciencesCatholic University of the Sacred HeartCampobassoItaly
  8. 8.Electrophisiology and Pacing Unit. Hygeia HospitalAthensGreece
  9. 9.Cardiac Arrhythmia Research CenterCentro Cardiologico Monzino IRCCSMilanItaly