Kalp Pili Elektrodlarının Çıkarılmasında Kullanılan İki Farklı Mekanik Dilatör Kılıfın Akut ve Uzun Dönem Etkinliğinin Değerlendirilmesi

Abstract

ABSTRACT Bahadır N. Evaluation of acute and long term efficiency of two types mechanical dilatator sheath which is used in removal cardiac implantable devices’ electrodes. Hacettepe University, Faculty of Medicine, Cardiology Thesis. Ankara, 2019. Parallel to an increase in the frequency of use cardiac implantable electronic devices (CIED); the need for effective and reliable methods is increasing in the management of such problems like device upgrade, device related infection, electrode dysfunction and dislodgement. Although the technology that is used for transvenous removal of CIED electrodes, has seen significant improvement over the last decade; this procedure is still associated with morbidity and mortality. After implantation transvenous leads are often encapsulated with fibrotic capsules by different humoral and cellular mechanisms. Powered extraction devices are needed in removal of the leads have long implant duration. The comparative data are essential and limited among different types of extraction tools. The aim of study is to compare procedural/clinical outcomes and adverse events in retropectively analyzed patients who underwent lead extraction using by two different rotational mechanical dilatator sheaths. From July 2009 to June 2018, 566 lead extractions from 302 patients (median age:60, %72 male) by using TightRailTM and Evoluation® mechanical dilatator sheaths were analyzed for both efficacy and safety. According to the types of the sheath used; two groups were determinated; Evolution® group (233 lead extractions from 133 patient) and TightRailTM group (333 lead extractions from 169 patients). In the Evolution® group, %57,9 of patients undergoing lead extraction have defibrillation leads, %87,6 of extracted leads have passive fixation mechanism; lead dwell median time is 5,1 years; the most common reason of lead extraction is lead dysfunction by %57,9. In the TightRailTM group, %63,3 of patients undergoing lead extraction have defibrillation leads, %73,1 of extracted leads have passive fixation mechanism; lead dwell median time is 5 years; the most common reason of lead extraction is CIED related infection by %49,1. In this study, all implantable cardioverter defibrillators have dual coil systems. There is no statistically significant difference between Evolution® and TightRailTM groups in procedural success (%93,9; %94), clinical success (%99,2; %98) and total complications (%15; %8,9) (p>0,05) respectively. Clinical success is determinated lower in patients who have passive fixation leads, long lead dwell time and more lead number (p>0,05). In multivariate analysis of factors with significant effect on procedure success; lead dwell time, extracted lead number and leukocyte levels are shown as independent risk factors that affect the success of procedure (p<0,05). The median duration of follow-up was 4 years and when all-cause mortality data were eveluated during this period; totally 73 patients have mortality with %25,6 in the Evolution® group and %23,1 in the TightRailTM group. There is no statistically significant difference between Evolution® and TightRailTM groups in long term mortality (p>0,05). There is a significant relationship between mortality and patients who were more older and have defibrillation leads and have concominant diseases like diabetes mellitus, chronic renal disease, atrial fibrillation and heart failure (p<0,05). In multivariate analysis of factors with significant effect on all-cause mortality; chronic renal disease, heart failure and coagulopathy are shown as independent risk factors that affect the all-cause mortality (p<0,05). In conclusion, there is no statistically significant difference in efficacy, safety and all-cause mortality at acute and long term follow up of patients who underwent transvenous lead extraction with both mechanical dilator sheaths.

Keywords: Transvenous lead extraction, mechanical rotational sheath, success, mortality.