TY - JOUR
T1 - 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
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
PY - 2013/10
Y1 - 2013/10
N2 - 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.
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.
KW - Connector
KW - DF-1
KW - DF-4
KW - Defibrillation lead
KW - Implantable cardioverter defibrillator
KW - Lead performance
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U2 - 10.1007/s10840-013-9814-6
DO - 10.1007/s10840-013-9814-6
M3 - Article
C2 - 23820882
AN - SCOPUS:84883773378
SN - 1383-875X
VL - 38
SP - 11
EP - 18
JO - Journal of Interventional Cardiac Electrophysiology
JF - Journal of Interventional Cardiac Electrophysiology
IS - 1
ER -