The aim of this study was to evaluate the efficacy and safety of the stepwise mechanical transvenous lead extraction approach in a patient population with chronically implanted transvenous leads with a long dwell time. From January 2014 till December 2018, all lead extractions with lead dwell time ≥5 years performed at our tertiary centre were retrospectively analysed. A total of 173 leads, from 78 patients (median age 68 years; 81% male) with a median dwell time of 9 years (interquartile range [IQR] 5) were extracted, with three or more leads in 42% of the patients. Right atrial leads: 41%; right ventricular pacing leads: 16%; implantable cardioverter‐defibrillator (ICD) leads: 31% (72% dual coil); coronary sinus leads: 12%. The majority (75%) of the leads had an active fixation. Most frequent indication for extraction was pocket infection/erosion (76%). Overall clinical success was 97%, and complete procedural success was 93%. Venous patency, assessed with venous angiography, was well preserved in 93% of the cases. The overall procedural complication rate was 3.8% (2.6% major and 1.3% minor). Despite the complexity of the population and a very long dwell time (median 9 years), a clinical success rate of 97% was achieved with the stepwise mechanical approach. Analysis of impeding progression of pectoral extraction suggests that dense fibrosis and sharp lead curvature in the transvenous trajectory pose a challenge. Complication rate was low, and acute venous patency was generally well preserved.
Background Implantable cardioverter-defibrillators (ICD) are effective in the prevention of sudden cardiac death and treating life-threatening arrhythmias. As the number of older patients increases, the number of implanted devices does as well. Evidence for current guidelines is mostly derived from trials conducted decades ago, in selected patient groups. Communicating the risks and benefits of an ICD to patients can be challenging. Shared decision making with the use of a decision aid has proven to result in more active patient participation and improved outcomes in several fields. Purpose The aim of our study is to evaluate the effect of an ICD specific decision aid in clinical practice. Methods We developed an evidence based decision aid according to the Delphi method. The decision aid was tested in 6 Dutch centres within a stepped wedge clustered randomized trial. We compared pre-procedural counselling with and without the use of a decision aid. Level of shared decision making was measured with the SDM-Q-9 in patients and SDM-Q-doc in caregivers. Additionally, we measured decisional conflict in patients with the decisional conflict scale questionnaire (DCS). This includes a subscore on how informed patients deemed to be. We included a set of 4 knowledge questions in our questionnaire. Differences between scoresbetween groups were analysed using the Mann-Whitney U test or One-way ANOVA. For categorical variables, we used the Chi-square test or Fishers Exact test accordingly. Results In total, we retrieved questionnaires from 234 caregivers and 150 patients. The majority of the patients were male (75%) and the mean age was 70±9 years. Levels of shared decision making were marked high in all groups. With the use of a decision aid, caregivers experienced significantly more shared decision making (median 78 (IQR 62–84) versus 81 (IQR 71–87) in the decision aid group (p=0.002)). Patients reported low levels of decisional conflict in both groups. There were also no differences for the subscales of the DCS (median 17 (IQR 6–25) in the control group vs 14 (IQR 5–23) in the decision aid group (p>0.05)). Patients reported to be very well informed (DCS subscale score of 0 in the control group vs 8 with a decision aid, p<0.05), although they answered the knowledge quiz poorly in both settings, with only 1 patient (0.067%) answering all the four question correctly (p<0.05). Conclusions Patients and caregivers report high levels of shared decision making. This is likely due to a bias associated with the study design, in which all participating centres were required to conduct elaborate pre-implantation counselling with patients as standard care, which is different from current clinical practice. Despite the implications of an ICD procedure, there was no decisional conflict and patients report to be well informed. This is in spite of low scores on the knowledge quiz. This illustrates the phenomenon of the unconsciously uninformed patient. Funding Acknowledgement Type of funding source: Foundation. Main funding source(s): Federation of Medical Specialists (SKMS), Utrecht, The Netherlands
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