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Title: The analysis of indications for transvenous lead extraction in patients with a pacemaker, ICD and CRT


Introduction:The number of implantations of cardiovascular implantable electronic devices (PM, ICD, CRT) which manage the heart rhythm is increasing every year due to expanding indications for such a treatment. Rapid development of medicine leads to extending patients’ lifespan. On the other hand the CIEDs have become more complex and consist of more leads. Because of the limited capacity of the generators there is necessity of systematic replacements of the depleted devices which are surgical procedures. Patients undergoing surgical reoperations are often elderly with multiple comorbidities and have an increased susceptibility to infectious complications. The extended presence of leads in patients’ bodies facilitates their dysfunction. Probably, these are the factors which cause the increase in long-term complications in cardiac device therapy. Over the last two decades the techniques of transvenous lead extraction (TLE) have been developed as an alternative to surgical methods.Objective:The aim of the thesis is the analysis of the indications for transvenous lead extraction in patients of Department of Electrocardiology John Paul II Hospital in Cracow in relation to implantation techniques which were used and other patient-related and device-related risk factors for permanent pacing complications. ; Methods:The study comprises the records of all patients who underwent transve ; nous lead extraction in Department of Electrocardiology John Paul II Hospital in Cracow. The data of all referred patients in the registry were recorded prospectively from October 2011 when the first procedure was conducted. The analysis includes patients who meet criteria of transvenous lead extraction procedures proposed in theexpert consensus document by Heart Rhythm Society. Additionally, in patients with implanted Sprint Fidelis, Riata and Riata ST leads we applied the National Consultant in Cardiology Experts' Group Guidelines on dealing with patients implanted with some advisory defibrillator leads. We performed the transvenous lead extraction in patients with indications not listed in above mentioned documents such as heart perforation and significant lead-induced tricuspid regurgitation.The inclusion criteria were as follows: TLE procedure was conducted, the oldest lead targeted to removal has been implanted for more than one year, or a lead regardless of duration of implant requiring the assistance of specialized equipment that is not included as part of the typical implant package.Exclusion criteria were as follows: extraction of the lead(s) younger than one year which did not require the assistance of specialized equipment, lead extraction via surgical approach.The population was divided into 4 groups according to the indications for TLE procedure. In case of pa ; tients who presented with more than one type of indication, the main indication was the one with higher recommendation class according to HRS expert consensus document: group A – infectious indications (systemic infection: sepsis and/or endocarditis - certain or probable), group B – infectious indications (pocket infection, pocket infection with the signs of systemic infection which does not meet the criteria of lead-dependent infective endocarditis), group C – non-infectious indications (extraction of abandoned/damaged/redundant leads), group D – non-infectious indications (extraction of functional leads in case of device upgrade).The precisely described criteria allowed the assignment of each patient to certain group according to indications. Each group of indications was discussed in detail and the groups were compared with each other. Most of patients referred to our centre had class II indicationsaccording to HRS. The ipsilateral venography was the examination which allowed to specify the class either to IIa or IIb. Several parameters were chosen in order to assess their utility in prediction of lead electrical dysfunction. Furthermore, the usefulness of white blood count and C-reactive protein was assessed based on ROC curve determining the cut-off values for these tests. ; Results:Between October 2011 and July 2015 transvenous lead extraction procedures utilizing Coo ; k method were performed in 300 patients (106 female), aged 19.1 to 88.6 years (mean 67.2), with 549 leads, which met the criteria of inclusion to the study. There were 24, 35, 174 and 67 patients in the group A, B, C and D, respectively.Group A along with group D were characterized by the highest rate of prior medical encounters in the past year. Group A had the highest rate of nonfunctional/redundant leads.Group A along with group D were characterized by the highest rate of prior medical encounters in the past year and the largest number of nonfunctional/redundant leads. The most numerous group C compared with other groups had the best cardiac function measured with NYHA functional class and LVEF. The smallest mean number of leads in one patient was in group D, which consisted of patients requiring device upgrades. The largest mean number of prior device-related procedures per patient was observed in groups with infectious indications.Patients referred from other centers had significantly more often class I indications compared with class IIb indications.The risk factors predisposing to development of infective endocarditis in the assessed populations were: higher NYHA heart failure class, presence of nonfunctional/redundant leads and frequent prior medical encounters with the exclusion of dialysis.Patients with localized pocket infection in comparison with groups with noninfe ; ctious indications had apparently more medical encounters in the previous year.The analysis revealed that the strongest predictor of lead failure was the presence of defibrillator lead and implantation via subclavian vein puncture compared with cephalic vein cut-down.Elevated level of WBC above 13.45x103/ul and CRP above 68.2 mg/L was useful in determination of cardiac device related infective endocarditis and useless in establishing the diagnosis of pocket infection. ; Conclusions:1. The analysis of data from prospectively recorded registry of patients referred for TLE being classified in 4 main categories of indications facilitates the detailed evaluation of indications.2. The majority of patients (64%) were referred for TLE procedures because of class IIb indications, which creates the doubt whether the HRS recommendations are still up-to-date.3. The indications for TLE procedures varied widely between patients referred from other centers and patients from our center, which supports an assumption that the availability of TLE procedures in Poland is limited.4. Female patients accounted forof patients referred for TLE procedures.5. In the group of infectious indications dominated patients with localized pocket infection (59%) compared with patients with infective endocarditis.6. The risk factors for LDIE development were heart failure, presence of nonfunctional/redundant leads ; and prior medical encounters.7. Inflammatory markers such as WBC and CRP can be useful in diagnosis of LDIE, however demonstrated no use in diagnosis of pocket infection.8. The majority of patients underwent TLE procedures due to lead failure.9. The risk factors for lead failure were: puncture of subclavian vein compared with cephalic cut-down, atrial lead and the presence of defibrillator lead.

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2 - studia doktoranckie

Degree discipline:

choroby układu krążenia

Degree grantor:

Wydział Lekarski


Małecka, Barbara

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Jun 2, 2022

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Jan 18, 2017

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ZB-124733 Jun 2, 2022


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