Funding Acknowledgements Type of funding sources: Public grant(s) – National budget only. Main funding source(s): Medical School Brandenburg and Local Government Concil Brandenburg Background Pulmonary vein isolation (PVI) is one of the key therapies for patients with atrial fibrillation (AF), however, there are numerous recurrences after ablation. Improving cardiorespiratory fitness (CF) may result in fewer recurrences of AF. The aim of the present study (Brandenburg Enhance ACTIvity ONset after pulmonary vein isolation - BE-ACTION) was to evaluate the impact of increased physical activity in patients after PVI on the recurrence of AF. Methods From January 2018 to April 2021, 200 patients with scheduled PVI were randomized at 4 different centres and fitted with an activity tracker for 24-hour activity monitoring via mobile phone. Patients aged between 50 and 77 years with a BMI between 23 and 35 kg/m2 were included. Patients with orthopaedic limitations were excluded. Patients in the ACTION group (n=99) were contacted regularly by telephone by a physical therapist and intensively motivated if the steps fell below 6,000 steps per day. Patients in the No-ACTION group (n=101) received standard of care. A loop recorder was implanted in 74 patients; those who refused loop recorder implantation underwent 7-day Holter monitoring at 6 and 12 months after PVI. Recurrence was defined as any atrial arrhythmia >30 sec, cardioversion or need of redo ablation after blanking period (3 month) up to 12 month. Results The number of steps per day increased in all pts from 7,918 (5,725-10,989) at week 2 after PVI to 9,511 (7,230-12,800) at 6 months and to 9,788 (6,962-12,152) at 12 months (p<0.001; Friedman), figure 1. In the ACTION group, the number of steps per day continued to increase between 6 and 12 months, whereas it decreased in the No-ACTION group. In total, recurrence of arrhythmia was found in 58 patients (29.9%: 31 patients with loop recorder, 14 with Holter monitoring and 13 with ECG). Recurrence occurred in 24 patients (25%) in the ACTION group and 34 patients (35%) in the No-ACTION group (p=0.140), table 1. Conclusion The level of daily physical activity was unexpectedly high in this study. The use of an activity tracker led to an increased daily physical activity in patients with AF after PVI. A further increase of activity did not reduce the recurrence of atrial arrhythmia in the ACTION group.
OnBehalf GALLERY investigators Background The number of cardiac implantable electronic device (CIED)-associated complications such as infection, lead dysfunction or thrombotic events is continuously rising and thus making transvenous lead extraction (TLE) an ever more needed procedure in clinical practice today. Patients with abandoned leads represent a special cohort with a potentially higher susceptibility to CIED-related infections and vascular complications. Moreover, according to literature abandoned leads seem to be associated with more procedural complications and mortality during TLE. Aim The aim of this study was to provide an insight on safety, procedural outcome and risk prediction on pacemaker patients with abandoned leads undergoing TLE from the largest national laser-sheath registry to date. Methods + Results: We conducted a retrospective analysis of the GALLERY database, which collected 2533 patients undergoing TLE in Germany between 2013 and 2017. Out of 903 pacemaker patients, who underwent TLE, 226 patients (25.0%) with abandoned leads were identified. Those patients had a higher number of leads per patient (3.2 ± 0.8 vs. 1.9 ± 0.3; ns) and longer lead dwell-times (168.0 ± 89.7 vs. 123.0 ± 69.2 months; p < 0.0001) compared to pacemaker patients without abandoned leads. There were no differences in age (71.5 vs. 72.3 years; ns), body mass index (26.5 ± 4.5 vs. 26.78 ± 4.8 kg/m2; ns) or gender distribution (69.0 vs. 66.5% male; ns). Leading indication for TLE was device infection with no difference between groups (79.7 vs 77.8 %; ns). There were no differences in terms of pacemaker dependency, length of hospitalization or comorbidities. Patients with abandoned leads had longer procedure times (112.0 ± 69.0 vs. 86.4 ± 53.0 minutes; p < 0.0001) and a higher incidence of procedural complications (6.6 vs. 3.1%; p = 0.03), but there were no differences in neither procedural and clinical success rates (96.5 vs. 97.3%; ns), nor all-cause mortality (1.33 vs. 2.66%; ns). Multivariate logistic regression revealed abandoned leads (OR 2.1, CI 1.0-4.4, p = 0.04) and female gender (OR 2.4, CI 1.2-4.9, p = 0.02) as independent predictors for procedural complications. Systemic infection (OR 5.4, CI 2.0-14.8, p = 0.001) and chronic kidney disease (OR 4.0, CI 1.5-10.7, p = 0.007) were strong predictors for all-cause mortality in patients with indwelling pacemaker. Patient age > 75 years (OR 3.9, CI 2.7-5.6, p < 0.0001) and a lead dwell-time > 10 years (OR 1.6, CI 1.1-2.2, p = 0.01) were identified as risk factors for an infectious cause for TLE. Conclusion Abandoned leads are frequently encountered in pacemaker patients undergoing TLE and pose an important risk factor for procedural complications. Systemic CIED-related infections are the strongest driver of mortality in this patient cohort and urgently call for further improvements in early diagnosis and prevention.
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