Effectiveness of single- vs dual-coil implantable defibrillator leads: An observational analysis from the SIMPLE study
Por:
Neuzner, J, Hohnloser, SH, Kutyifa, V, Glikson, M, Dietze, T, Mabo, P, Vinolas, X, Kautzner, J, O'Hara, G, Lawo, T, Brachmann, J, VanErven, L, Gadler, F, Appl, U, Wang, J, Connolly, SJ, Healey, JS
Publicada:
1 jul 2019
Resumen:
Introduction Dual-coil leads (DC-leads) were the standard of choice since the first nonthoracotomy implantable cardioverter/defibrillator (ICD). We used contemporary data to determine if DC-leads offer any advantage over single-coil leads (SC-leads), in terms of defibrillation efficacy, safety, clinical outcome, and complication rates. Methods and Results In the Shockless IMPLant Evaluation study, 2500 patients received a first implanted ICD and were randomized to implantation with or without defibrillation testing. Two thousand and four hundred seventy-five patients received SC-coil or DC-coil leads (SC-leads in 1025/2475 patients; 41.4%). In patients who underwent defibrillation testing (n = 1204), patients with both lead types were equally likely to achieve an adequate defibrillation safety margin (88.8% vs 91.2%; P = 0.16). There was no overall effect of lead type on the primary study endpoint of "failed appropriate shock or arrhythmic death" (adjusted HR 1.18; 95% CI, 0.86-1.62; P = 0.300), and on all-cause mortality (SC-leads: 5.34%/year; DC-leads: 5.48%/year; adjusted HR 1.16; 95% CI, 0.94-1.43; P = 0.168). However, among patients without prior heart failure (HF), and SC-leads had a significantly higher risk of failed appropriate shock or arrhythmic death (adjusted HR 7.02; 95% CI, 2.41-20.5). There were no differences in complication rates. Conclusion In this nonrandomized evaluation, there was no overall difference in defibrillation efficacy, safety, outcome, and complication rates between SC-leads and DC-leads. However, DC-leads were associated with a reduction in the composite of failed appropriate shock or arrhythmic death in the subgroup of non-HF patients. Considering riskier future lead extraction with DC-leads, SC-leads appears to be preferable in the majority of patients.
Filiaciones:
Neuzner, J:
Klinikum Kassel, Kassel, Germany
Hohnloser, SH:
Goethe Univ, Univ Hosp Frankfurt, Dept Cardiol, Frankfurt, Germany
Kutyifa, V:
Semmelweis Univ, Budapest, Hungary
Univ Rochester, Med Ctr, Rochester, NY 14642 USA
Glikson, M:
Sheba Med Ctr, Leviev Heart Ctr, Tel Hashomer, Israel
Dietze, T:
Ambulantes Herzzentrum Kassel, Kassel, Germany
Mabo, P:
Ctr Hosp Univ, Rennes, France
Vinolas, X:
Hosp Santa Creu & Sant Pau, Barcelona, Spain
Kautzner, J:
Inst Clin & Expt Med, Prague, Czech Republic
O'Hara, G:
Inst Univ Cardiol & Pneumol, Quebec City, PQ, Canada
Lawo, T:
Elisabeth Hosp, Recklinghausen, Germany
Brachmann, J:
Regiomed Kliniken, Coburg, Germany
VanErven, L:
Leiden Univ, Med Ctr, Leiden, Netherlands
Gadler, F:
Karolinska Hosp, Stockholm, Sweden
Appl, U:
Boston Sci, Minneapolis, MN USA
Boston Sci, Brussels, Belgium
Wang, J:
Populat Hlth Res Inst, Hamilton, ON, Canada
Connolly, SJ:
Mc Master Univ, Hamilton, ON, Canada
Healey, JS:
Populat Hlth Res Inst, Hamilton, ON, Canada
Mc Master Univ, Hamilton, ON, Canada
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