26 research outputs found

    Impact of lockdown during Covid‐19 pandemic on physical activity and arrhythmia burden in heart failure patients

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    Background Restricted outdoor activity during COVID-19 related lockdown may accelerate heart failure (HF) progression and thereby increase cardiac arrhythmias. We analyzed the impact of March/April 2020 lockdown on physical activity and arrhythmia burden in HF patients treated with cardiac resynchronization therapy (CRT) devices with daily, automatic remote monitoring (RM) function. Methods The study cohort included 405 HF patients enrolled in Observation of Clinical Routine Care for Heart Failure Patients Implanted with BIOTRONIK CRT Devices (BIO|STREAM.HF) registry in 16 countries, who had left ventricular ejection fraction (LVEF) = 8 min/day in 46.5% of patients; predictors were higher LVEF, lower NYHA class, no defibrillator indication, and more activity before lockdown. AHRE burden increased by >= 17 min/day in 4.7% of patients; predictors were history of atrial fibrillation, higher LVEF, higher body mass index, and activity decrease during lockdown. Conclusion Unfavorable changes in physical activity, AHRE burden, and follow-up rate were observed during lockdown, but not in ventricular arrhythmia

    Use of an Atrial Lead with Very Short Tip-To-Ring Spacing Avoids Oversensing of Far-Field R-Wave

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    The AVOID-FFS (Avoidance of Far-Field R-wave Sensing) study aimed to investigate whether an atrial lead with a very short tip-to-ring spacing without optimization of pacemaker settings shows equally low incidence of far-field R-wave sensing (FFS) when compared to a conventional atrial lead in combination with optimization of the programming.Patients receiving a dual chamber pacemaker were randomly assigned to receive an atrial lead with a tip-to-ring spacing of 1.1 mm or a lead with a conventional tip-to-ring spacing of 10 mm. Postventricular atrial blanking (PVAB) was programmed to the shortest possible value of 60 ms in the study group, and to an individually determined optimized value in the control group. Atrial sensing threshold was programmed to 0.3 mV in both groups. False positive mode switch caused by FFS was evaluated at one and three months post implantation.A total of 204 patients (121 male; age 73±10 years) were included in the study. False positive mode switch caused by FFS was detected in one (1%) patient of the study group and two (2%) patients of the control group (p = 0.62).The use of an atrial electrode with a very short tip-to-ring spacing avoids inappropriate mode switch caused by FFS without the need for individual PVAB optimization.ClinicalTrials.gov NCT00512915

    Single-procedure outcomes and quality-of-life improvement 12 months post-cryoballoon ablation in persistent atrial fibrillation : results from the multicenter CRYO4PERSISTENT AF trial

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    Objectives: The CRYO4PERSISTENT AF (Cryoballoon Ablation for Early Persistent Atrial Fibrillation) trial aims to report long-term outcomes after a single pulmonary vein isolation (PVI)–only ablation procedure using the second-generation cryoballoon in persistent atrial fibrillation (PerAF) patients. Background: Pulmonary vein isolation is recognized as the cornerstone of atrial fibrillation (AF) ablation, including ablation of PerAF. Methods: The CRYO4PERSISTENT AF trial (NCT02213731) is a prospective, multicenter, single-arm trial designed to assess single-procedure outcomes of PVI using the cryoballoon. The primary endpoint was freedom from AF, atrial flutter, or atrial tachycardia ≄30 s after a 90-day blanking period. After enrollment, but before ablation, patients without 100% AF burden (18-h Holter monitoring or 3 consecutive electrocardiograms in a time frame ≄14 days) were excluded. Patients were followed at 3, 6, and 12 months, with 48-h Holter monitoring at 6 and 12 months. Quality of life and symptoms were evaluated at baseline and 12 months. Arrhythmia recurrence and adverse events were adjudicated by an independent committee. Results: A total of 101 patients (62 ± 11 years of age, 74% men, left ventricular ejection fraction 56 ± 8%, left atrial diameter 43 ± 5 mm) meeting criteria, undergoing cryoballoon-based PVI, with follow-up data, were included. Kaplan-Meier estimate of freedom from AF, atrial flutter, or atrial tachycardia recurrence was 60.7% at 12 months. Compared with baseline, there were significantly fewer patients with arrhythmia-related symptoms at 12 months (16% vs. 92%; p < 0.0001). The symptom reduction was supported by significant improvement in 36-Item Short Form Health Survey composite scores and European Heart Rhythm Association score at 12 months. The only device related event was transient phrenic nerve injury in 2 (2%) patients, with resolution pre-discharge. Conclusions: Cryoballoon ablation for treatment of PerAF demonstrated 61% single-procedure success at 12 months post-ablation in addition to significant reduction in arrhythmia-related symptoms and improved quality of life. (Cryoballoon Ablation for Early Persistent Atrial Fibrillation [Cryo4 Persistent AF]; NCT02213731

    News from the Cold Chamber: Clinical Experiences of POLARx versus Arctic Front Advance for Single-Shot Pulmonary Vein Isolation

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    Cryoballoon (CB)-guided pulmonary vein isolation (PVI) represents a cornerstone in the treatment of atrial fibrillation (AF). Recently, a novel balloon-guided single shot device (POLARx, Boston Scientific) was designed. Our study aimed to compare the efficacy, safety and characteristics of the novel CB system with the established one (Arctic Front Advance (Pro), AFA, Medtronic). A total number of 596 patients undergoing CB-guided ablation for AF were included. 65 patients (65.0 &plusmn; 11.6, 31% female) undergoing PVI with the POLARx were compared to a cohort of 531 consecutive patients (63.0 &plusmn; 27.9, 25% female) treated with AFA. Acute PVI was achieved in all patients (n = 596, 100%). Total procedure duration (POLARx 113.3 &plusmn; 23.2 min, AFA 100.9 &plusmn; 21.3 min; p &lt; 0.001) and fluoroscopy time (POLARx 10.5 &plusmn; 5.9 min, AFA 4.8 &plusmn; 3.6 min; p &lt; 0.001) were significantly longer in the POLARx group. The POLARx balloon achieved significantly lower nadir temperatures (POLARx &minus;57.7 &plusmn; 0.9 &deg;C, AFA &minus;45.1 &plusmn; 2.6 &deg;C; p &lt; 0.001) and a significantly higher percentage of pulmonary veins successfully isolated with the first freeze (p = 0.027 *). One major complication occurred in the POLARx (2%) and three (1%) in the AFA group. Both ablation systems are comparably safe and effective. AF ablation utilizing the POLARx system is associated with longer procedure and fluoroscopy times as well as lower nadir temperatures

    Distribution of programmed PVAB during follow-up by randomization groups.

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    <p>Nine patients of the study group initially received a PVAB that was erroneously programmed to a value other than 60 ms which was corrected after one month in eight of the patients and remained prolonged in one patient. None of these patients had inappropriate mode switch due to FFS. One patient of the study group patient exhibited inappropriate mode switch due to FFS and the PVAB was then individually optimized (150 ms). For the control group PVAB is shown as determined to be optimal at discharge. In case of changes of the PVAB programming during the follow-up, the longest programmed PVAB for both groups are displayed.</p
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