|
This complaint is from a literature source.The following literature cite has been reviewed: ruwald mh, johannessen a, hansen ml, haugdal m, worck r, hansen j.Focal pulsed field ablation and ultrahigh-density mapping - versatile tools for all atrial arrhythmias? initial procedural experiences.J interv card electrophysiol.2023 may 30.Doi: 10.1007/s10840-023-01570-4.Epub ahead of print.Pmid: 37249807.Objective/methods/study data: background focal pulsed feld ablation (fpfa) is a novel and promising method of cardiac ablation.The aim of this study was to report the feasibility, short-term safety, and procedural fndings for a broad spectrum of ablated atrial arrhythmias.Methods patients (n=51) scheduled for ablation of atrial arrhythmias were prospectively included and underwent fpfa using the galvanize centauri generator with energy delivery through commercially available ablation catheters with ultrahigh-density (uhdx) 3d electroanatomic voltage/local activation time map evaluations.Workfow, procedural data, and peri-procedural technical errors and complications are described.Results planned ablation strategy was achieved with fpfa-only in 48/51 (94%) of the cases.Ablation strategy was frst-time pulmonary vein isolation (pvi) in 17/51 (36%), repeat ablation in 18/51 (38%), pvi+in 13/51 (28%), and cavotricuspid isthmus block (cti)-only in 3/51 (6%).The mean procedure time was 104±31 min (frst-time pvi), 114±26 min (repeat procedure), 152±36 min (pvi+), and 62±17 min (cti).Mean uhdx mapping time to assess lesion formation and block after ablation was 7±4 min with 5485±4809 points.First pass acute (linear) isolation with bidirectional block for anatomical lesion sets was 120/124 (97%) for all pvs, 17/17 (100%) for (any) isthmus, and 14/17 (82%) for left atrium posterior wall (lapw).We observed several time-consuming integration errors with the used ablation system (mean 3.4±3.7 errors/ procedure), one transient inferior st elevation when ablating cti resolved by intravenous nitroglycerine and one transient av block requiring temporary pacing for>24 h.Conclusions fpfa was a highly versatile method to treat atrial arrhythmias with high frst-pass efciency.Uhdx revealed acute homogenous low-voltage lesions in ablated areas.More data is needed to establish lesion durability and limitations of fpfa.Lot, model and catalog number are not available, but the suspected biosense device possibly associated with reported adverse events: thermocool smarttouch.Other biosense webster devices that were also used in this study: pentaray or octaray mapping catheters, carto system non-biosense webster devices that were also used in this study: centauri generator (galvanize ep).Exact quantities of products cannot be accurately determined as patients can experience more than adverse event and the data is summarized.Adverse event(s) and provided interventions possibly associated with an unidentified thermocool smarttouch ablation catheter: qty 1 case of prolonged complete atrioventricular av block in a patient with frst-degree av block present at the beginning of the procedure, necessitating a temporary pacemaker for 24 h (surgical intervention), but hereafter resolution of the block.During the pvi and ablation of the right sided veins ¿ first progression to a left bundle branch block became apparent.Shortly after procedure termination, a further progression of the conduction delay led to second-degree av block and then complete av block (heart block av).Qty 1 one case of st-elevations (electrocardiogram st segment elevation) in the inferior leads was also observed despite an initial dose of 0.2 mg of nitroglycerine had been given prophylactic before initiation of a cti-b.St-elevations occurred approximately 5 min after the administration during fpfa applications.An additional 0.2-mg nitroglycerine administration resolved the st-elevations (medication required) and no further problems were seen.
|
|
This complaint is from a literature source.The following literature cite has been reviewed: ruwald mh, johannessen a, hansen ml, haugdal m, worck r, hansen j.Focal pulsed field ablation and ultrahigh-density mapping - versatile tools for all atrial arrhythmias? initial procedural experiences.J interv card electrophysiol.2023 may 30.Doi: 10.1007/s10840-023-01570-4.Epub ahead of print.Pmid: 37249807.No device was received for analysis at the time of submission of the initial 3500a.Since the product was not returned for analysis, no product failure analysis can be conducted, and no determination of possible contributing factors could be made.Device history record (dhr) review cannot be conducted because the lot number was provided by the customer.This report is being submitted pursuant to the provisions of 21 cfr, part 4.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).
|
