scholarly journals Ablation Index‐guided point‐by‐point ablation versus Grid annotation‐guided dragging for pulmonary vein isolation: A randomized controlled trial

Author(s):  
Mark J. Mulder ◽  
Michiel J. B. Kemme ◽  
Luuk H. G. A. Hopman ◽  
Amaya M. D. Hagen ◽  
Peter M. Ven ◽  
...  
Heart Rhythm ◽  
2015 ◽  
Vol 12 (9) ◽  
pp. 1907-1915 ◽  
Author(s):  
Massimiliano Faustino ◽  
Carmine Pizzi ◽  
Tullio Agricola ◽  
Borejda Xhyheri ◽  
Grazia Maria Costa ◽  
...  

Heart Rhythm ◽  
2016 ◽  
Vol 13 (2) ◽  
pp. 407-415 ◽  
Author(s):  
Hamid Ghanbari ◽  
Ronak Jani ◽  
Atheer Hussain-Amin ◽  
Wassim Al-Assad ◽  
Elizabeth Huether ◽  
...  

2021 ◽  
Vol 42 (Supplement_1) ◽  
Author(s):  
M.J Mulder ◽  
M.J.B Kemme ◽  
L.H.G.A Hopman ◽  
A.M.D Hagen ◽  
P.M Van De Ven ◽  
...  

Abstract Background Pulmonary vein isolation (PVI) with radiofrequency (RF) ablation is an important treatment option in symptomatic atrial fibrillation (AF) patients. Ablation Index (AI) has recently attracted considerable interest as a guide for PVI procedures and combines contact force, RF application time and ablation power into a single metric. A limitation of ablation strategies guided by AI is the impossibility to use a catheter dragging technique. Although comparative studies are sparse, ablation using a catheter dragging technique may shorten procedural duration and improve PVI durability by creating uninterrupted linear ablation lesions. These ablation lesions can be visualized by a grid (grid annotation), which may provide valuable information on both lesion depth and lesion contiguity. We compared an AF ablation approach guided by grid annotation, with a point-by-point AI annotation approach in a single-center randomized study. Methods Eighty-eight patients with paroxysmal or persistent AF were randomized 1:1 to undergo RF-PVI guided by either grid annotation or AI annotation. In the grid annotation arm, ablation was visualized using automatic generation of 1mm3 grid points projected on the electroanatomic map, with grid points coloring red after 15 seconds of ablation while meeting predefined stability and contact force criteria. Ablation was performed aiming for a continuous circle of red grid points. In the AI annotation arm, ablation was visualized using automatically generated lesion tags with a diameter of 3 mm. AI target values were set at 380 and 500 for posterior/inferior and anterior/roof segments, respectively. Ablation lesions were created in a point-by-point fashion, aiming for a maximum interlesion distance of 6 mm. All study participants were followed up for 12 months after PVI using out-patient clinic visits, ECGs, 24-hour Holter monitoring and a mobile-based one-lead ECG device to assess heart rhythm when symptoms suggestive of an arrhythmia occurred. Results The primary endpoint of procedure time was not different between the two randomization arms (grid annotation 71±19 min, AI annotation 72±26 min, p=0.765, Figure 1A). RF time was significantly longer in the grid annotation arm compared with the AI annotation arm (49±8 min vs. 37±8 min, respectively, p<0.001). Neither fluoroscopy time or radiation dose were different between the randomization arms. All patients completed 12 months of follow-up and recurrent atrial tachyarrhythmias were observed in 29 patients (33%). Recurrence of any atrial tachyarrhythmia was documented in 10 patients (23%) in the grid annotation arm compared with 19 patients (42%) in the AI annotation arm, which did not reach statistical significance by log-rank test (p=0.074, Figure 1B). Conclusions Findings from this randomized controlled study suggest that grid annotation may provide an alternative approach for RF-PVI using AI, allowing for ablation with the catheter dragging technique. FUNDunding Acknowledgement Type of funding sources: Private company. Main funding source(s): Biosense Webster, Inc. Figure 1


2020 ◽  
Vol 29 (1S) ◽  
pp. 412-424
Author(s):  
Elissa L. Conlon ◽  
Emily J. Braun ◽  
Edna M. Babbitt ◽  
Leora R. Cherney

Purpose This study reports on the treatment fidelity procedures implemented during a 5-year randomized controlled trial comparing intensive and distributed comprehensive aphasia therapy. Specifically, the results of 1 treatment, verb network strengthening treatment (VNeST), are examined. Method Eight participants were recruited for each of 7 consecutive cohorts for a total of 56 participants. Participants completed 60 hr of aphasia therapy, including 15 hr of VNeST. Two experienced speech-language pathologists delivered the treatment. To promote treatment fidelity, the study team developed a detailed manual of procedures and fidelity checklists, completed role plays to standardize treatment administration, and video-recorded all treatment sessions for review. To assess protocol adherence during treatment delivery, trained research assistants not involved in the treatment reviewed video recordings of a subset of randomly selected VNeST treatment sessions and completed the fidelity checklists. This process was completed for 32 participants representing 2 early cohorts and 2 later cohorts, which allowed for measurement of protocol adherence over time. Percent accuracy of protocol adherence was calculated across clinicians, cohorts, and study condition (intensive vs. distributed therapy). Results The fidelity procedures were sufficient to promote and verify a high level of adherence to the treatment protocol across clinicians, cohorts, and study condition. Conclusion Treatment fidelity strategies and monitoring are feasible when incorporated into the study design. Treatment fidelity monitoring should be completed at regular intervals during the course of a study to ensure that high levels of protocol adherence are maintained over time and across conditions.


2019 ◽  
Vol 62 (12) ◽  
pp. 4464-4482 ◽  
Author(s):  
Diane L. Kendall ◽  
Megan Oelke Moldestad ◽  
Wesley Allen ◽  
Janaki Torrence ◽  
Stephen E. Nadeau

Purpose The ultimate goal of anomia treatment should be to achieve gains in exemplars trained in the therapy session, as well as generalization to untrained exemplars and contexts. The purpose of this study was to test the efficacy of phonomotor treatment, a treatment focusing on enhancement of phonological sequence knowledge, against semantic feature analysis (SFA), a lexical-semantic therapy that focuses on enhancement of semantic knowledge and is well known and commonly used to treat anomia in aphasia. Method In a between-groups randomized controlled trial, 58 persons with aphasia characterized by anomia and phonological dysfunction were randomized to receive 56–60 hr of intensively delivered treatment over 6 weeks with testing pretreatment, posttreatment, and 3 months posttreatment termination. Results There was no significant between-groups difference on the primary outcome measure (untrained nouns phonologically and semantically unrelated to each treatment) at 3 months posttreatment. Significant within-group immediately posttreatment acquisition effects for confrontation naming and response latency were observed for both groups. Treatment-specific generalization effects for confrontation naming were observed for both groups immediately and 3 months posttreatment; a significant decrease in response latency was observed at both time points for the SFA group only. Finally, significant within-group differences on the Comprehensive Aphasia Test–Disability Questionnaire ( Swinburn, Porter, & Howard, 2004 ) were observed both immediately and 3 months posttreatment for the SFA group, and significant within-group differences on the Functional Outcome Questionnaire ( Glueckauf et al., 2003 ) were found for both treatment groups 3 months posttreatment. Discussion Our results are consistent with those of prior studies that have shown that SFA treatment and phonomotor treatment generalize to untrained words that share features (semantic or phonological sequence, respectively) with the training set. However, they show that there is no significant generalization to untrained words that do not share semantic features or phonological sequence features.


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