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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

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Journal of Interventional Cardiac Electrophysiology Aims and scope Submit manuscript

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 cap**. 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.

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Acknowledgments

The authors thank Cecilia Rubaudo for her assistance in the preparation of this manuscript.

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Authors and Affiliations

  1. Department of Internal Medicine, Division of Cardiology, University of Rome “Tor Vergata”, Viale Oxford, 81, 00133, Rome, Italy

    Giovanni B. Forleo, Germana Panattoni, Domenico Sergi, Luca Santini & Francesco Romeo

  2. Texas Cardiac Arrhythmia Institute at St. David’s Medical Center, Austin, TX, USA

    Luigi Di Biase & Andrea Natale

  3. Department of Cardiology, University of Foggia, Foggia, Italy

    Luigi Di Biase

  4. Albert Einstein College of Medicine, Montefiore Hospital, New York, NY, USA

    Luigi Di Biase

  5. Department of Biomedical Engineering, University of Austin, Austin, TX, USA

    Luigi Di Biase

  6. Arrhythmia and Electrophysiology Center, St. Ambrogio Clinical Institute, Milan, Italy

    Massimo Mantica

  7. Cardiovascular Department, Center for High Technology Research and Education in Biomedical Sciences, Catholic University of the Sacred Heart, Campobasso, Italy

    Matteo Santamaria & Quintino Parisi

  8. Electrophisiology and Pacing Unit. Hygeia Hospital, Athens, Greece

    Lida P. Papavasileiou

  9. Cardiac Arrhythmia Research Center, Centro Cardiologico Monzino IRCCS, Milan, Italy

    Claudio Tondo

Authors
  1. Giovanni B. Forleo
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  2. Luigi Di Biase
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  3. Massimo Mantica
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  4. Germana Panattoni
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  5. Matteo Santamaria
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  6. Quintino Parisi
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  7. Domenico Sergi
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  8. Lida P. Papavasileiou
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  9. Luca Santini
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  10. Claudio Tondo
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  11. Andrea Natale
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  12. Francesco Romeo
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Corresponding author

Correspondence to Giovanni B. Forleo.

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Forleo, G.B., Di Biase, L., Mantica, M. et al. 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. J Interv Card Electrophysiol 38, 11–18 (2013). https://doi.org/10.1007/s10840-013-9814-6

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  • DOI: https://doi.org/10.1007/s10840-013-9814-6

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