The learning curve associated with the introduction of the subcutaneous implantable defibrillator

. 2016 Jul ; 18 (7) : 1010-5. [epub] 20150831

Jazyk angličtina Země Anglie, Velká Británie Médium print-electronic

Typ dokumentu časopisecké články, multicentrická studie, pozorovací studie

Perzistentní odkaz   https://www.medvik.cz/link/pmid26324840

AIMS: The subcutaneous implantable cardioverter defibrillator (S-ICD) was introduced to overcome complications related to transvenous leads. Adoption of the S-ICD requires implanters to learn a new implantation technique. The aim of this study was to assess the learning curve for S-ICD implanters with respect to implant-related complications, procedure time, and inappropriate shocks (IASs). METHODS AND RESULTS: In a pooled cohort from two clinical S-ICD databases, the IDE Trial and the EFFORTLESS Registry, complications, IASs at 180 days follow-up and implant procedure duration were assessed. Patients were grouped in quartiles based on experience of the implanter and Kaplan-Meier estimates of complication and IAS rates were calculated. A total of 882 patients implanted in 61 centres by 107 implanters with a median of 4 implants (IQR 1,8) were analysed. There were a total of 59 patients with complications and 48 patients with IAS. The complication rate decreased significantly from 9.8% in Quartile 1 (least experience) to 5.4% in Quartile 4 (most experience) (P = 0.02) and non-significantly for IAS from 7.9 to 4.8% (P = 0.10). Multivariable analysis demonstrated a hazard ratio of 0.78 (P = 0.045) for complications and 1.01 (P = 0.958) for IAS. Dual-zone programming increased with experience of the individual implanter (P < 0.001), which reduced IAS significantly in the multivariable model (HR 0.44, P = 0.01). Procedure time decreased from 75 to 65 min (P < 0.001). The complication rate and procedure time stabilized after Quartile 2 (>13 implants). CONCLUSION: There is a short and significant learning curve associated with physicians adopting the S-ICD. Performance stabilizes after 13 implants.

Zobrazit více v PubMed

Burke MC, Gold MR, Knight BP, Barr CS, Theuns DA, Boersma LV et al. Safety and efficacy of the totally subcutaneous implantable defibrillator. PubMed

Kirkfeldt RE, Johansen JB, Nohr EA, Jorgensen OD, Nielsen JC. Complications after cardiac implantable electronic device implantations: an analysis of a complete, nationwide cohort in Denmark. PubMed PMC

Gadler F, Valzania C, Linde C. Current use of implantable electrical devices in Sweden: data from the Swedish pacemaker and implantable cardioverter-defibrillator registry. PubMed

Bardy G, Smith W, Hood M, Crozier I, Melton I, Jordaens L et al. An entirely subcutaneous implantable cardioverter–defibrillator. PubMed

Gold MR, Theuns DA, Knight BP, Sturdivant JL, Sanghera R, Ellenbogen KA et al. Head-to-head comparison of arrhythmia discrimination performance of subcutaneous and transvenous ICD arrhythmia detection algorithms: the START study. PubMed

Hopper A, Jamison M, Lewis W. Learning curves in surgical practice. PubMed PMC

Al-Khatib SM, Lucas FL, Jollis JG, Malenka DJ, Wennberg DE. The relation between patients’ outcomes and the volume of cardioverter-defibrillator implantation procedures performed by physicians treating Medicare beneficiaries. PubMed

Krahn AD, Lee DS, Birnie D, Healey JS, Crystal E, Dorian P et al. Predictors of short-term complications after implantable cardioverter-defibrillator replacement: results from the Ontario ICD database. PubMed

Curtis JP, Luebbert JJ, Wang Y, Rathore SS, Heidenreich PA, Hammill SC et al. Association of physician certification and outcomes among patients receiving. PubMed PMC

Olde Nordkamp LR, Dabiri Abkenari L, Boersma LV, Maass AH, de Groot JR, van Oostrom AJ et al. The entirely subcutaneous implantable cardioverter-defibrillator: initial clinical experience in a large Dutch cohort. PubMed

Weiss R, Knight BP, Gold MR, Leon AR, Herre JM, Hood M et al. Safety and efficacy of a totally subcutaneous implantable-cardioverter defibrillator. PubMed

Lambiase PD, Barr C, Theuns DA, Knops RE, Neuzil P, Johansen JB et al. Worldwide experience with a totally subcutaneous implantable defibrillator: early results from the EFFORTLESS S-ICD registry. PubMed PMC

Knops RE, Olde Nordkamp LR, de Groot JR, Wilde AA. Two-incision technique for implantation of the subcutaneous implantable cardioverter-defibrillator. PubMed

Moss AJ, Hall WJ, Cannom DS, Klein H, Brown MW, Daubert JP et al. Cardiac-resynchronization therapy for the prevention of heart-failure events. PubMed

Brisben AJ, Burke MC, Knight BP, Hahn SJ, Herrmann KL, Allavatam V et al. A new algorithm to reduce inappropriate therapy in the S-ICD system. PubMed

Kooiman KM, Knops RE, Olde Nordkamp L, Wilde AA, de Groot JR. Inappropriate subcutaneous implantable cardioverter-defibrillator shocks due to T-wave oversensing can be prevented: implications for management. PubMed

Olde Nordkamp LR, Brouwer TF, Barr C, Theuns DA, Boersma LV, Johansen JB et al. Inappropriate shocks in the subcutaneous ICD: incidence, predictors and management. PubMed

Najít záznam

Citační ukazatele

Pouze přihlášení uživatelé

Možnosti archivace