A randomized trial evaluating the accuracy of AF detection by four external ambulatory ECG monitors compared to permanent pacemaker AF detection

Purpose: Several external cardiac monitors (ECMs) have recently been developed. These have never been compared to ‘gold standard’ monitoring with concurrently implanted DDDRP pacemakers. The accuracy of AF detection of Zio XT Monitor (ZM), NUUBO Vest (NV) and Carnation Ambulatory Monitor (CAM) compared with Novacor ‘R’ Test 4 (RT) in patients (pts) with DDDRP PPM advanced Holters as the comparator, was evaluated. Methods: Twenty-one pts. with AF and a DDDRP PPM, each acting as their own control subject, wore every ECM for 2 weeks in randomized order. PPM downloads were performed at application and removal. Device ECGs were compared for AF burden and individual AF episodes with PPM Holters. Pt acceptability, wear time, costs and time expenditure were evaluated. Results: RT AF burden was less accurate than the ZM, NV or CAM (p < 0.05). Probability of inaccurate AF diagnosis was higher for RT than ZM or CAM OR 12.31 and 5.85, respectively (p = 0.025 and p = 0.042). ZM wear time was longer than the RT: 307 h vs. 224 h; p = 0.02. Acceptability was greater for CAM than RT (1.86 ± 2.63 compared with 0.57 ± 1.17 for CAM; p = 0.024). All ECMs were more expensive than RT (p < 0.00001). Conclusions: All new ECMs were more expensive than the RT system; however, the ZM, NV and CAM are all more accurate than current standard practice RT device in AF burden assessment. The RT is more likely to give inaccurate diagnoses than ZM or CAM. This may have clinical implications

A randomized comparison of retrograde left-sided versus anterograde right-sided ablation of the atrioventricular junction

Background: Catheter ablation of the atrioventricular node (AVN) is an effective treatment for patients with symptomatic atrial fibrillation. This study compares the success rate, procedure time, radiation time, and complication rates of retrograde left-sided (LSA) and anterograde right-sided (RSA) AVN ablation in a randomised controlled trial. / Methods: Thirty-one patients undergoing AVN ablation were randomized to either LSA (15 patients) or RSA (16 patients). Crossover occurred after six unsuccessful radiofrequency (RF) applications. / Results: The LSA cohort had a mean age of 77.00 ± 5.17 and the RSA cohort was 79.44 ± 6.08 (p =.0240). There were five crossovers from LSA to RSA and there was one crossover from RSA to LSA. There was no significant difference in ablation time between LSA and RSA (210.40 ± 179.77 vs. 192.19 ± 130.29 seconds, p =.748). There was no significant difference in procedure time, fluoroscopy time, radiation dose, or number of RF applications between the two groups. There was 1 (6.67%) serious adverse event in the LSA group and 1 (6.25%) in the RSA group due to femoral hematomas requiring blood transfusion or intervention. There was no significant difference in patient-reported discomfort between LSA and RSA (16.43 ± 20.67 vs. 17.87 ± 28.08, p =.877). The study was stopped before full recruitment due to futility. / Conclusions: Retrograde LSA of the AVN does not reduce RF applications, procedure time, or radiation exposure compared with conventional RSA and cannot be recommended as a first-line clinical approach

A trial of three non-invasive blood pressure monitors compared with invasive blood pressure assessment in atrial fibrillation and sinus rhythm

OBJECTIVE: To investigate the accuracy of three non‐invasive blood pressure (BP) devices in atrial fibrillation (AF) compared with invasive arterial BP. METHODS: One hundred patients aged 45‐90 years, 63% male (50 in AF and 50 age matched controls in sinus rhythm [SR]) were identified with arterial lines measuring beat‐to‐beat BP fluctuation. Non‐invasive BP measurements utilising the manual sphygmomanometer (MS), PulseCor R6.5 (PC) and automated sphygmomanometer (AS) were taken simultaneously with invasive BP in a randomised sequence. This was repeated three times in each patient. RESULTS: In SR differences in systolic BP (SBP) for MS, AS and PC were −0.34 mm Hg (95% CI −2.31 to 1.63; P = .733), −3.80 mm Hg (95% CI −5.73 to −1.87; P = .0001) and −3.90 mm Hg (95% CI −5.90 to −1.90; P = .0001) and for diastolic BP (DBP) were 6.02 mm Hg (95% CI 4.39‐7.64; P < .0001), 8.95 mm Hg (95% CI 7.36‐10.55; P < .0001) and 7.54 mm Hg (95% CI 5.89‐9.18; P < .0001), respectively. In AF mean differences in SBP for MS, AS and PC were −7.33 mm Hg (95% CI −9.11 to −5.55; P < .0001), −5.29 mm Hg (95% CI −7.08 to −3.50; P < .0001) and −5.75 mm Hg (95% CI −7.54 to −3.96; P < .0001) respectively and for DBP were 5.28 mm Hg (95% CI 4.03‐6.54; P < .0001), 6.26 mm Hg (95% CI 5.00‐7.52; P < .0001) and 6.89 mm Hg (95% CI 5.64‐8.15; P < .0001) respectively. CONCLUSIONS: The MS is accurate in SR because of direct assessment of Korotkoff sounds. Non‐invasive BP assessment in AF is significantly less accurate. These findings have important prognostic and therapeutic implications

Poster Session II, July 14th 2010 — Abstracts Improvements in the design of a kayak-ergometer using a sliding footrest-seat complex

AbstractAs observed previously in rowing, kayaking an ergometer becomes more and more popular. Nowadays, indoor kayak championships are organized performed on ergometer designed with a fixed footrest-seat complex. The main goal when one designs ergometers is to reproduce as closest as possible the on-water conditions. The reliability with on-water condition is usually assessed using both physiological and kinematics parameters. The previous studies of our research group have shown that the dynamics of the in situ movement has also to be reproduced. In other words, major muscular groups (who generated the joint torque and by the way the contact forces) involved in kayaking should be recruit with the same timing during on-water and ergometer kayaking. At the 7th ISEA conference, our research group presented a method based on numerical optimization to design a kayak ergometer equipped with a sliding footrest-seat complex that reproduces the acceleration generated in flatwater kayak. Based on these preliminary results, we have constructed a new ergometer. Then, the purpose of this study was to present the last developments performed on this ergometer and preliminary 3D kinematics analysis from elite kayakers. The characteristics (stiffness and damping) of the bungee cord linking the back of the frame with the trolley were determined using our previous results. An air brake, composed of a flywheel with a heavy wheel and two freewheel-pulleys on a shaft, simulated the water drag on the blades. However, a magnetic brake was added for specific training sessions. The paddle was linked to the pulleys by two ropes. Each side of the frame is equipped with one slide (1 dof in translation) in order to always keep the directions of the ropes parallel to the long axis of the ergometer whatever the instant of the cycle. First trials performed with elite athlete showed the robustness of all the mechanisms developed. 3D kinematic analysis showed the relevance of the adding slides when compared with on-water paddle trajectories observed during the propulsion phase. An instrumentation (3D force sensors at each contact) coupled with a specific interface that allows real time feedback is under development. This innovative ergometer will be used to collect dynamic and kinematic parameters. They will serve as input data of our simulator in order to carry out intra-athlete comparisons and to still improve the design of kayak ergometers

Long Term outcomes of percutaneous atrial fibrillation ablation in patients with continuous monitoring

INTRODUCTION: There is limited data using continuous monitoring to assess outcomes of atrial fibrillation (AF) ablation. This study assessed long-term outcomes of AF ablation in patients with implantable cardiac devices. METHODS: 207 patients (mean age 68.1 ± 9.5, 50.3% men) undergoing ablation for symptomatic AF were followed up for a mean period of 924.5 ± 636.7 days. Techniques included The Pulmonary Vein Ablation Catheter (PVAC) (59.4%), cryoablation (17.4%), point by point (14.0%) and The Novel Irrigated Multipolar Radiofrequency Ablation Catheter (nMARQ) (9.2%). RESULTS: 130 (62.8%) patients had paroxysmal AF (PAF) and 77 (37.2%) persistent AF. First ablation and repeat ablation reduced AF burden significantly (relative risk 0.91, [95% CI 0.89 to 0.94]; P <0.0001 and 0.90, [95% CI, 0.86-0.94]; P <0.0001). Median AF burden in PAF patients reduced from 1.05% (interquartile range [IQR], 0.1%-8.70%) to 0.10% ([IQR], 0%-2.28%) at one year and this was maintained out to four-years. Persistent AF burden reduced from 99.9% ([IQR], 51.53%-100%) to 0.30% ([IQR], 0%-77.25%) at one year increasing to 87.3% ([IQR], 4.25%-100%) after four years. If a second ablation was required, point-by-point ablation achieved greater reduction in AF burden (relative risk, 0.77 [95% CI, 0.65-0.91]; P <0.01). CONCLUSION: Ablation reduces AF burden both acutely and in the long-term. If a second ablation was required the point-by-point technique achieved greater reductions in AF burden than "single-shot" technologies. Persistent AF burden increased to near pre ablation levels by year 4 suggesting a different mechanism from PAF patients where this increase did not occur

A randomized sham-controlled study of pulmonary vein isolation in symptomatic atrial fibrillation (The SHAM-PVI study): Study design and rationale

INTRODUCTION: Pulmonary vein (PV) isolation has been shown to reduce atrial fibrillation (AF) burden and symptoms in patients. However, to date previous studies have been unblinded raising the possibility of a placebo effect to account for differences in outcomes. HYPOTHESIS & METHODS: The objective of this study is to compare PV isolation to a sham procedure in patients with symptomatic AF. The SHAM-PVI study is a double blind randomized controlled clinical trial. 140 patients with symptomatic paroxysmal or persistent AF will be randomized to either PV isolation (with cryoballoon ablation) or a sham procedure (with phrenic nerve pacing). All patients will receive an implantable loop recorder. The primary outcome is total AF burden at 6 months postrandomisation (excluding the 3 month blanking period). Key secondary outcomes include (1) time to symptomatic and asymptomatic atrial tachyarrhythmia (2) total atrial tachyarrhythmia episodes and (3) patient reported outcome measures. RESULTS: Enrollment was initiated in January 2020. Through April 2023 119 patients have been recruited. Results are expected to be disseminated in 2024. CONCLUSION: This study compares PV isolation using cryoablation to a sham procedure. The study will estimate the effect of PV isolation on AF burden

A preliminary assessment of the effects of ATI-2042 in subjects with paroxysmal atrial fibrillation using implanted pacemaker methodology

Aims ATI-2042 (budiodarone) is a chemical analogue of amiodarone with a half life of 7 h. It is electrophysiologically similar to amiodarone, but may not have metabolic and interaction side effects. The sophisticated electrocardiograph logs of advanced DDDRP pacemakers were used to monitor the efficacy of ATI-2042. The aim of this study was to determine the preliminary efficacy and safety of ATI-2042 in patients with paroxsymal atrial fibrillation (PAF) and pacemakers. Methods and results Six women with AF burden (AFB) between 1 and 50% underwent six sequential 2-week study periods. Patients received 200 mg bid of ATI-2042 during Period 2 (p2), 400 mg bid during p3, 600 mg bid during p4, 800 mg bid during p5, and no drug during baseline and washout (p1 and p6). Pacemaker data for the primary outcome measure AFB were downloaded during each period. Mean AFB decreased between baseline and all doses: AFB at baseline (SD) was 20.3 ± 14.6% and mean AFB at 200 mg bid was 5.2 ± 4.2%, at 400 mg bid 5.2 ± 5.2%, at 600 mg bid 2.8 ± 3.4%, and at 800 mg bid 1.5 ± 0.5%. The mean reductions in AFB at all doses of ATI-2042 were statistically significant (P < 0.005). Atrial fibrillation burden increased in washout. Atrial fibrillation episodes tended to increase with ATI-2042, but this was offset by substantial decreases in episode duration. ATI-2042 was generally well tolerated. Conclusion ATI-2042 effectively reduced AFB over all doses studied by reducing mean episode duration. A large-scale study will be required to confirm this effect

Pacemaker battery scandal.

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