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Effectiveness of single- vs dual-coil implantable defibrillator leads: An observational analysis from the SIMPLE study

J. Neuzner, SH. Hohnloser, V. Kutyifa, M. Glikson, T. Dietze, P. Mabo, X. Vinolas, J. Kautzner, G. O'Hara, T. Lawo, J. Brachmann, L. VanErven, F. Gadler, U. Appl, J. Wang, SJ. Connolly, JS. Healey,

. 2019 ; 30 (7) : 1078-1085. [pub] 20190422

Jazyk angličtina Země Spojené státy americké

Typ dokumentu srovnávací studie, časopisecké články, pozorovací studie

Perzistentní odkaz   https://www.medvik.cz/link/bmc20025803

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.

Citace poskytuje Crossref.org

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$a INTRODUCTION: Dual-coil leads (DC-leads) were the standard of choice since the first nonthoracotomy implantable cardioverter/defibrillator (ICD). We used contemporary data to determine if DC-leads offer any advantage over single-coil leads (SC-leads), in terms of defibrillation efficacy, safety, clinical outcome, and complication rates. METHODS AND RESULTS: In the Shockless IMPLant Evaluation study, 2500 patients received a first implanted ICD and were randomized to implantation with or without defibrillation testing. Two thousand and four hundred seventy-five patients received SC-coil or DC-coil leads (SC-leads in 1025/2475 patients; 41.4%). In patients who underwent defibrillation testing (n = 1204), patients with both lead types were equally likely to achieve an adequate defibrillation safety margin (88.8% vs 91.2%; P = 0.16). There was no overall effect of lead type on the primary study endpoint of "failed appropriate shock or arrhythmic death" (adjusted HR 1.18; 95% CI, 0.86-1.62; P = 0.300), and on all-cause mortality (SC-leads: 5.34%/year; DC-leads: 5.48%/year; adjusted HR 1.16; 95% CI, 0.94-1.43; P = 0.168). However, among patients without prior heart failure (HF), and SC-leads had a significantly higher risk of failed appropriate shock or arrhythmic death (adjusted HR 7.02; 95% CI, 2.41-20.5). There were no differences in complication rates. CONCLUSION: In this nonrandomized evaluation, there was no overall difference in defibrillation efficacy, safety, outcome, and complication rates between SC-leads and DC-leads. However, DC-leads were associated with a reduction in the composite of failed appropriate shock or arrhythmic death in the subgroup of non-HF patients. Considering riskier future lead extraction with DC-leads, SC-leads appears to be preferable in the majority of patients.
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$a Hohnloser, Stefan H $u Department of Cardiology, University Hospital Frankfurt, Goethe University, Frankfurt, Germany.
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$a Kutyifa, Valentina $u Semmelweis University, Budapest, Hungary. University of Rochester Medical Center, Rochester, New York.
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$a Glikson, Michael $u Leviev Heart Center, Sheba Medical Center, Tel Hashomer, Israel.
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$a Dietze, Thomas $u Ambulantes Herzzentrum Kassel, Kassel, Germany.
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$a Mabo, Philippe $u Centre Hospitalier Universitaire, Rennes, France.
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$a Vinolas, Xavier $u Hospital de Santa Creu I Saint Pau, Barcelona, Spain.
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$a Kautzner, Josef $u Institute for Clinical and Experimental Medicine, Prague, Czech Republic.
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$a O'Hara, Gilles $u Institute Universitaire de Cardiologie et de Pneumologie de, Quebec, QC, Canada.
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$a Lawo, Thomas $u Elisabeth Krankenhaus, Recklinghausen, Germany.
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$a Brachmann, Johannes $u Regiomed Kliniken, Coburg, Germany.
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$a VanErven, Liselot $u Leiden University Medical Center, Leiden, the Netherlands.
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$a Gadler, Fredrik $u Karolinska Hospital, Stockholm, Sweden.
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$a Appl, Ursula $u Boston Scientific, Minneapolis, Minnesota. Boston Scientific, Brussels, Belgium.
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$a Wang, Jia $u Population Health Research Institute, Hamilton, Canada.
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$a Connolly, Stuart J $u Mc Master University, Hamilton, Canada.
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$a Healey, Jeff S $u Population Health Research Institute, Hamilton, Canada. Mc Master University, Hamilton, Canada.
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