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This complaint is from a literature source.The following literature cite has been reviewed: joza j, nair gm, birnie dh, nery pb, redpath cj, sarrazin jf, champagne j, bernick j, wells ga, essebag v; other members of the aware study consortium (augmented wide area circumferential catheter ablation for reduction of atrial fibrillation recurrence).High-power short-duration versus low-power long-duration ablation for pulmonary vein isolation: a substudy of the aware randomized controlled trial.J cardiovasc electrophysiol.2024 jan;35(1):136-145.Doi: 10.1111/jce.16123.Epub 2023 nov 21.Pmid: 37990448.Objective/methods/study data: introduction: pulmonary vein isolations (pvi) are being performed using a high-power, short-duration (hpsd) strategy.The purpose of this study was to compare the clinical efficacy and safety outcomes of an hpsd versus low-power, long-duration (lpld) approach to pvi in patients with paroxysmal atrial fibrillation (af).Methods: patients were grouped according to a hpsd (=40 w) or lpld (=35 w) strategy.The primary endpoint was the 1-year recurrence of any atrial arrhythmia lasting =30 s, detected using three 14-day ambulatory continuous ecg monitoring.Procedural and safety endpoints were also evaluated.The primary analysis were regression models incorporating propensity scores yielding adjusted relative risk (rra ) and mean difference (mda ) estimates.Results: of the 398 patients included in the aware trial, 173 (43%) underwent hpsd and 225 (57%) lpld ablation.The distribution of power was 50 w in 75%, 45 w in 20%, and 40 w in 5% in the hpsd group, and 35 w with 25 w on the posterior wall in the lpld group.The primary outcome was not statistically significant at 30.1% versus 22.2% in hpsd and lpld groups with rra 0.77 (95% confidence interval [ci]) 0.55-1.10; p =.165).The secondary outcome of repeat catheter ablation was not statistically significant at 6.9% and 9.8% (rra 1.59 [95% ci 0.77-3.30]; p =.208) respectively, nor was the incidence of any ecg documented af during the blanking period: 1.7% versus 8.0% (rra 3.95 [95% ci 1.00-15.61; p =.049) in the hpsd versus lpld group respectively.The total procedure time was significantly shorter in the hpsd group (mda 97.5 min [95% ci 84.8-110.4)]; p <.0001) with no difference in adjudicated serious adverse events.Conclusions: an hpsd strategy was associated with significantly shorter procedural times with similar efficacy in terms of clinical arrhythmia recurrence.Importantly, there was no signal for increased harm with a hpsd strategy.Lot, model and catalog number are not available, but the suspected biosense device possibly associated with reported adverse events: smarttouch or smarttouch sf.The authors do not specify which specific catheter is associated with each adverse event.The events are captured under smarttouch sf until further clarification can be received from authors.Table 4 notes the serious adverse events and it is noted that pseudoaneurysm and aterio-venous fistula are events associated with a use of a sheath.The identity of the sheaths used in the study are not provided by the article.Concomitant other biosense webster devices that were also used in this study: carto visitag software, non-biosense webster devices that were also used in this study: n/a, adverse event(s) and provided interventions possibly associated with unidentified smarttouch sf ablation catheter (table 4): qty 3 atrial fibrillation (arrhythmia), (recognized procedural complication), qty 2 atrial flutter (arrhythmia), (recognized procedural complication), qty 3 (congestive heart failure), (recognized procedural complication), qty 1 (major bleed)ing requiring transfusion (serious injury), qty 2 (minor bleed)ing (minor injury), qty 1 (hypotension), (recognized procedural complication), qty 1 (pneumonia), (recognized procedural complication), qty 2 (cardiac perforation), with tamponade (recognized procedural complication), qty 1 (pericarditis), (recognized procedural complication), qty 1 (pulmonary vein stenosis), (recognized procedural complication), qty 1 esophageal ulcer perforation (esophageal perforation) (recognized procedural complication).
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This complaint is from a literature source.The following literature cite has been reviewed: joza j, nair gm, birnie dh, nery pb, redpath cj, sarrazin jf, champagne j, bernick j, wells ga, essebag v; other members of the aware study consortium (augmented wide area circumferential catheter ablation for reduction of atrial fibrillation recurrence).High-power short-duration versus low-power long-duration ablation for pulmonary vein isolation: a substudy of the aware randomized controlled trial.J cardiovasc electrophysiol.2024 jan;35(1):136-145.Doi: 10.1111/jce.16123.Epub 2023 nov 21.Pmid: 37990448.Since no device has been received for analysis, no product investigation can be performed, and the customer complaint cannot be confirmed.Manufacturing record evaluation (mre) cannot be conducted because no lot number was provided by the customer.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by biosense webster, inc., or its employees that the report constitutes an admission that the product, biosense webster, inc., or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Manufacturer's reference number: (b)(4).
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