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

Research output: Contribution to journalArticle

3 Citations (Scopus)

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.

Original languageEnglish (US)
Pages (from-to)11-18
Number of pages8
JournalJournal of Interventional Cardiac Electrophysiology
Volume38
Issue number1
DOIs
StatePublished - Oct 2013

Fingerprint

Implantable Defibrillators
Safety
Cardiac Resynchronization Therapy
Lead
Outcome Assessment (Health Care)
Technology
Incidence
Infection

Keywords

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

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine
  • Physiology (medical)

Cite this

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

In: Journal of Interventional Cardiac Electrophysiology, Vol. 38, No. 1, 10.2013, p. 11-18.

Research output: Contribution to journalArticle

Forleo, Giovanni B. ; Di Biase, Luigi ; Mantica, Massimo ; Panattoni, Germana ; Santamaria, Matteo ; Parisi, Quintino ; Sergi, Domenico ; Papavasileiou, Lida P. ; Santini, Luca ; Tondo, Claudio ; Natale, Andrea ; Romeo, Francesco. / 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. In: Journal of Interventional Cardiac Electrophysiology. 2013 ; Vol. 38, No. 1. pp. 11-18.
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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.",
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AU - Forleo, Giovanni B.

AU - Di Biase, Luigi

AU - Mantica, Massimo

AU - Panattoni, Germana

AU - Santamaria, Matteo

AU - Parisi, Quintino

AU - Sergi, Domenico

AU - Papavasileiou, Lida P.

AU - Santini, Luca

AU - Tondo, Claudio

AU - Natale, Andrea

AU - Romeo, Francesco

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AB - 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.

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KW - Lead performance

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