Novel occlusion tool software for pulmonary vein occlusion verification in atrial fibrillation cryoballoon ablation

2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
F Solimene ◽  
F.M Cauti ◽  
G Stabile ◽  
P Rossi ◽  
V Schillaci ◽  
...  

Abstract Background Optimal pulmonary vein (PV) occlusion, checked with selective contrast injection, is mandatory to obtain an effective PV isolation with a cryoballoon. Purpose The purpose of this study was to verify the feasibility of a new dielectric sensing system in assessing PV occlusion during cryoballoon ablation in patients with atrial fibrillation (AF). Methods We enrolled 25 consecutive patients with paroxysmal or persistent AF. After transseptal access a detailed image reconstruction of left atrium and PVs was achieved with a decapolar circular mapping catheter and a novel dielectric imaging system. The degree of PV occlusion with the inflated cryoballoon catheter was verified by a new occlusion tool software of the dielectric imaging system and compared to the angiography with dye injection in each PV. Results A total of 114 PV cryoballoon occlusion were tested. The new occlusion tool software showed a 91.7% sensitivity and 81.5% specificity in assessing a complete PV occlusion verified with dye injection. The positive predictive value was 84.6% and the negative predictive value was 89.8%. Acute isolation was achieved in all PVs. No 30 days complications were observed. Conclusion This is the first study that demonstrates the feasibility of a new occlusion tool software, using the novel dielectric imaging system, in verifying the degree of PV occlusion during cryoballoon ablation. Funding Acknowledgement Type of funding source: None

EP Europace ◽  
2021 ◽  
Vol 23 (Supplement_3) ◽  
Author(s):  
V Schillaci ◽  
G Stabile ◽  
A Arestia ◽  
G Shopova ◽  
F Solimene

Abstract Funding Acknowledgements Type of funding sources: None. Background. Fluoroscopy is commonly used in cryoballoon catheter ablation for pulmonary vein (PV) isolation procedures in patients with atrial fibrillation (AF). Objective The purpose of this study was to verify the feasibility of a new dielectric imaging system in reducing the radiation exposure during cryoballoon ablation in patients with AF. Methods We enrolled 26 consecutive patients with paroxysmal AF: 13 patients underwent the procedure under fluoroscopy guidance before the new system introduction, while 13 patient underwent the procedure under fluoroscopy and KODEX-EPD system guidance with its occlusion tool software. After transseptal access a detailed image reconstruction of left atrium and PVs was achieved with the Achieve octapolar circular mapping catheter and the cryoablation was performed with the Arctic Front Advance cryoballoon. Results Total time of the procedure was comparable between the two groups (90.15 ± 28.67 vs 80.77 ± 17.17 using KODEX-EPD, p = 0.34), while fluoroscopy time was significantly lower in the group using KODEX-EPD (16.92 ± 8.96 vs 5.54 ± 2.06, p < 0.01). Acute isolation was achieved in all PVs. No 30 days complication was observed. Conclusion This is the first study that demonstrates the feasibility of a reduce fluoroscopy workflow using the novel KODEX-EPD system in a cryoballoon procedure. Abstract Figure. Fluoroscopy time


2020 ◽  
Vol 6 (8) ◽  
pp. 516-519
Author(s):  
Filippo Maria Cauti ◽  
Pietro Rossi ◽  
Marco Polselli ◽  
Luigi Iaia ◽  
Carlo Maria Giannitti ◽  
...  

2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
V Schillaci ◽  
G Stabile ◽  
A Arestia ◽  
G Shopova ◽  
A Agresta ◽  
...  

Abstract Background Fluoroscopy is commonly used in cryoballoon catheter ablation for pulmonary vein (PV) isolation procedures in patients with atrial fibrillation (AF). Purpose The purpose of this study was to verify the feasibility of a new dielectric imaging system in reducing the radiation exposure during cryoballoon ablation in patients with AF. Methods We enrolled 40 consecutive patients with paroxysmal AF: 20 patients underwent the procedure under fluoroscopy guidance before the new system introduction, while 20 patient underwent the procedure under fluoroscopy and a new dielectric imaging system guidance with its occlusion tool software. After transseptal access a detailed image reconstruction of left atrium and PVs was achieved with an octapolar circular mapping catheter and the cryoablation was performed with a cryoballoon catheter. Results Total time of the procedure was comparable between the two groups (90.15±28.67 vs 80.77±17.17 using the dielectric imaging system, p=0.34), while fluoroscopy time was significantly lower in the group using the new dielectric imaging system (16.92±8.96 vs 5.54±2.06, p<0.01). Acute isolation was achieved in all PVs. No 30 days complication was observed. Conclusion This is the first study that demonstrates the feasibility of a reduce fluoroscopy workflow using the novel dielectric imaging system in a cryoballoon procedure. Funding Acknowledgement Type of funding source: None


EP Europace ◽  
2021 ◽  
Vol 23 (Supplement_3) ◽  
Author(s):  
FM Cauti ◽  
P Rossi ◽  
L Iaia ◽  
M Polselli ◽  
A Pecere ◽  
...  

Abstract Funding Acknowledgements Type of funding sources: None. Background. Atrial fibrillation (AF) is the most frequent sustained arrhythmia worldwide and Cryoballoon ablation (CB) has become a consolidated alternative to the radiofrequency pulmonary vein (PV) isolation. However, CB requires fluoroscopy and dye injections to verify the occlusion grade. The accuracy of the earlier version of the Kodex Occlusion Tool software has been studied. Purpose. The purpose of this study was to verify the accuracy of the second generation Kodex Occlusion Tool Software of a new dielectric system imaging compared to its first generation to detect PV occlusion during CB ablation in patients with AF. Methods. 15 consecutive patients with paroxysmal AF were enrolled in the study and underwent the procedure with the guidance of the first generation version (1.4.6) of the Kodex Occlusion Tool software. The Kodex recorded procedural data were used to replay the case using the Kodex second generation version (1.4.7) of the Occlusion Tool software when clinically available. After transseptal access, a detailed image reconstruction of left atrium and PVs was achieved with an octa-polar circular mapping catheter, PV occlusion was assessed with the Occlusion Tool Software and compared with standard dye injection and angiography, the cryoablation was then performed with a cryoballoon catheter. Results. A total of 72 PVs CB occlusions were tested. The old version showed 90.7% sensitivity and 76.5% specificity in assessing a complete PV occlusion verified with contrast medium injection. The positive predictive value was 80.3%, and the negative predictive value was 88.6%. The new version showed 94.8% sensitivity and 93.7% specificity in assessing a complete PV occlusion verified with same contrast medium injection data. The positive predictive value was 98.2%, and the negative predictive value was 93.7%. Acute isolation was achieved in all PVs and no 30-day complication was observed. Conclusion. This study demonstrates an increased accuracy of new Occlusion Tool software of the Kodex dielectric imaging system to assess the degree of PV occlusion during a CB ablation. Abstract Figure. Occlusion tool software 1.4.6 vs 1.4.7


2019 ◽  
Vol 20 (1) ◽  
Author(s):  
Shaojie Chen ◽  
Boris Schmidt ◽  
Stefano Bordignon ◽  
Fabrizio Bologna ◽  
K. R. Julian Chun

Abstract Background Cryoballoon ablation is an established procedure for atrial fibrillation (AF). Patients who had previous pulmonary surgery undergoing pulmonary vein isolation (PVI) were seldom reported. Case presentation We describe an AF ablation using the novel short-tip third-generation cryoballoon in a patient with resected pulmonary vein. All pulmonary veins were successfully isolated without complication. The short-tip third-generation cryoballoon shows advantageous profile in PVI for AF patients with previous pulmonary surgery. Conclusions This report indicates that for AF patient who had previous resected PV surgery, the short-tip CB 3 provides an ideal device option for real-time PVI.


Author(s):  
Filippo Maria Cauti ◽  
Francesco Solimene ◽  
Giuseppe Stabile ◽  
Marco Polselli ◽  
Vincenzo Schillaci ◽  
...  

EP Europace ◽  
2020 ◽  
Vol 22 (Supplement_1) ◽  
Author(s):  
Z Eldadah ◽  
C Jons ◽  
Z Hollis ◽  
L Dekker ◽  
S Mathew ◽  
...  

Abstract Background  Successful delivery of continuous and durable pulmonary vein isolation (PVI) lesion sets is recognized as being critical to long-term clinical outcomes following ablation for atrial fibrillation (AF). Confirmation of PVI following cryoballoon ablation is commonly achieved using a 3.3F circular mapping catheter (CMC) which can be delivered through the central lumen of the cryoballoon, but other diagnostic tools may be used alone or in conjunction with the 3.3F CMC. A high-density, grid-style mapping catheter is now available in multiple geographies; use in cryoballoon ablation procedures and associated outcomes has not been previously reported. Purpose  To evaluate diagnostic catheter usage patterns in cryoablation procedures and identify associated trends in procedural characteristics and acute outcomes. Methods  Self-reported procedural data was prospectively collected in AF cryoablation cases utilizing various diagnostic catheter tools, including the 3.3F CMC and high-density, grid-style mapping catheter (HD Grid). Procedural characteristics and acute outcomes, including the incidence and location of gaps post-ablation, were recorded and analyzed. Results  Data was collected in 23 cryoablation procedures performed in 7 centers across the United States and Europe. De novo and repeat ablations represented 65.2% and 21.7% of cases, respectively (13.0% not reported). 3D mapping was employed in 95.7% of cases. A left common pulmonary vein was present and ablated in 8.7% (2/23). The 28mm cryoballoon was utilized in all cases, with a single case using both a 23mm and 28mm cryoballoon. The 3.3F CMC was used to confirm isolation in all cases using a variety of techniques: voltage mapping (60.9%), exit block (56.5%), entrance block (30.4%), propagation mapping (4.3%), and activation mapping (4.3%); note: total exceeds 100% as more than one technique may be employed in a single case. In 18 cases, PVI was confirmed using a 3.3F CMC followed by secondary confirmation with HD Grid, enabling a direct comparison of the two technologies. The HD Grid identified a total of 12 gaps in 4 (22.2%) patients, which were missed by the 3.3F CMC (Figure 1). No adenosine or isoproterenol use was documented in any case. Conclusion(s): The 3.3F CMC is routinely used to confirm PVI following cryoballoon ablation for atrial fibrillation, but it may fail to identify gaps in some patients. Subsequent assessment of PVI using the HD Grid identified residual gaps in nearly a quarter of patients, suggesting that sensitivity for gap detection may be improved with this tool. Limitations of this analysis include the small sample size and workflows which consistently assessed PVI with the high-density mapping catheter after confirming isolation with the 3.3F CMC. Despite these limitations, the incidence of residual gaps observed is noteworthy and may warrant additional study. Abstract Figure.


2021 ◽  
Vol 42 (Supplement_1) ◽  
Author(s):  
F M Cauti ◽  
P Rossi ◽  
L Iaia ◽  
M Polselli ◽  
A Pecere ◽  
...  

Abstract Background Atrial fibrillation (AF) is the most frequent sustained arrhythmia worldwide and Cryoballoon ablation (CB) has become a consolidated alternative to the radiofrequency pulmonary vein (PV) isolation. However, CB requires fluoroscopy and dye injections to verify the occlusion grade. The accuracy of the earlier version of the Kodex Occlusion Tool software has been studied. Purpose The purpose of this study was to verify the accuracy of the second generation Kodex Occlusion Tool Software of a new dielectric system imaging compared to its first generation to detect PV occlusion during CB ablation in patients with AF. Methods 15 consecutive patients with paroxysmal AF were enrolled in the study and underwent the procedure with the guidance of the first generation version (1.4.6) of the Kodex Occlusion Tool software. The Kodex recorded procedural data were used to replay the case using the Kodex second generation version (1.4.7) of the Occlusion Tool software when clinically available. After transseptal access, a detailed image reconstruction of left atrium and PVs was achieved with an octa-polar circular mapping catheter, PV occlusion was assessed with the Occlusion Tool Software and compared with standard dye injection and angiography, the cryoablation was then performed with a cryoballoon catheter. Results A total of 74 PVs CB occlusions were tested. The old version showed 90.7% sensitivity and 74.2% specificity in assessing a complete PV occlusion verified with contrast medium injection. The positive predictive value was 82.9%, and the negative predictive value was 85.2%. The new version showed 94.8% sensitivity and 93.7% specificity in assessing a complete PV occlusion verified with same contrast medium injection data. The positive predictive value was 98.2%, and the negative predictive value was 93.7%. Acute isolation was achieved in all PVs and no 30-day complication was observed. Conclusion This study demonstrates an increased accuracy of new Occlusion Tool software of the Kodex dielectric imaging system to assess the degree of PV occlusion during a CB ablation. FUNDunding Acknowledgement Type of funding sources: None.


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