P451Optimizing the EP lab workflow in atrial fibrillation ablation - The use of Z stitch for groin access closure

EP Europace ◽  
2020 ◽  
Vol 22 (Supplement_1) ◽  
Author(s):  
V Velagic ◽  
I Prepolec ◽  
V Pasara ◽  
B Pezo-Nikolic ◽  
M Puljevic ◽  
...  

Abstract Introduction As catheter ablation became the standard therapy for atrial fibrillation (AF), the number of AF procedures has risen exponentially. Therefore, workflow optimization is crucial in order to meet the rising demands for EP interventions. Recently, instead of standard groin compression we have started using the "Z stitch" for introducers’ removal. This novel method does not necessitate protamine administration and often lengthy manual compression. Purpose We aim to demonstrate utilization of "Z stitch" for groin access closure in cryoballoon (CB) ablation and its impact on EP lab workflow. Methods We have analyzed all patients having undergone CB ablation utilizing the "Z stitch" (Z group) and the last 50 consecutive CB patients who received standard groin compression (non-Z group). Procedures were performed under conscious sedation. Both femoral veins were punctured and a single introducer was placed in each vein. A single transeptal puncture was preformed guided by intracardial ultrasound and a 28 mm cryoballoon was used. A single 180 seconds freeze strategy was employed. In the past, protamine was slowly administered after ablation and at least 15 minute manual groin compression was applied until no visual bleeding could be detected. Elastic bandage was placed around both groins. Later on, the "Z stitch" was used around both introducers without the need for protamine administration, manual compression and bandage placement (Picture). The stitches were removed next morning. Results A total of 100 consecutive patients (79% male, 61.2 ± 10.6 years old) were evaluated, 50 in both groups. There was no difference in the mean procedure duration ("skin to skin") between two groups. However, a total lab time was significantly longer in non-Z group. There was no differences in complication rates, which consisted solely of phrenic nerve palsy and groin complications. There was no AV fistula or pseudoaneurysms detected in our cohort (Table). Conclusion Utilization of Z stitches for introduces’ removal seems safe and effective way to achieve hemostasis after cryoballoon ablation. It abolishes the need for protamine administration which can cause serious advert events. Manual compression is no longer required. Consequently, EP lab workflow is improved, since the total lab time utilization per patient is significantly shortened. Results non-Z group Z group p Procedure duration (min) 69.4 ± 20.4 73.4 ± 24.8 0.380 Lab time (min) 129.9 ± 35.3 109.1 ± 30.6 0.002 Complications (N) 5 (2 hematoma) 4 (2 hematoma) NS Abstract Figure. Z stich

EP Europace ◽  
2021 ◽  
Vol 23 (Supplement_3) ◽  
Author(s):  
J Michaelsen ◽  
U Parade ◽  
H Bauerle ◽  
K-D Winter ◽  
U Rauschenbach ◽  
...  

Abstract Funding Acknowledgements Type of funding sources: None. OnBehalf REGIONAL Background Pulmonary vein isolation (PVI) using cryoballoon ablation (CBA) has become an established procedure for the treatment of symptomatic paroxysmal and persistent atrial fibrillation (AF). The safety and efficacy of PVI at community hospitals with low to moderate case numbers is unknown. Aim To determine safety and efficacy of PVI using CBA performed at community hospitals with limited annual case numbers. Methods 1004 PVI performed consecutively between 01/2019 and 09/2020 at 20 community hospitals (each <100 PVI using CBA/year) for symptomatic paroxysmal AF (n = 563) or persistentAF (n= 441) were included in this registry. CBA was performed considering local standards. Procedural data, efficacy and complications were determined. Results Mean number of PVI using CBA/year was 59 ± 26. Mean procedure time was 90.1 ± 31.6 min and mean fluoroscopy time was 19.2 ± 11.4 min. Isolation of all pulmonary veins could be achieved in 97.9% of patients, early termination of CBA due to phrenic nerve palsy was the most frequent reason for incomplete isolation. There was no in-hospital death. 2 patients (0.2%) suffered a clinical stroke. Pericardial effusion occurred in 6 patients (0.6%), 2 of them (0.2%) required pericardial drainage. Vascular complications occurred in 24 patients (2.4%), in 2 of these patients (0.2%) vascular surgery was required. In 48 patients (4.8 %) phrenic nerve palsy was noticed which persisted up to hospital discharge in 6 patients (0.6%). Conclusions PVI for paroxysmal or persistent AF using CBA can be performed at community hospitals with high efficacy and low complication rates despite low to moderate annual procedure numbers.


2018 ◽  
Vol 2018 ◽  
pp. 1-10 ◽  
Author(s):  
Ali H. Hachem ◽  
Joseph E. Marine ◽  
Housam A. Tahboub ◽  
Sana Kamdar ◽  
Shaffi Kanjwal ◽  
...  

Background. Pulmonary vein isolation is commonly performed using radiofrequency energy with cryoablation gaining acceptance. We performed a meta-analysis of randomized controlled trials which compared radiofrequency versus cryoablation for patients with atrial fibrillation. Methods. A systematic search strategy identified both published and unpublished articles from inception to November 10, 2016, in multiple databases. The primary outcomes for this meta-analysis were long-term freedom from atrial fibrillation at 12-month follow-up and overall postoperative complication rates. For all included studies, the methodological quality was assessed through the Cochrane Collaboration’s tool for risk of bias. Results. A total of 247 articles were identified with eight being included in this review as they satisfied the prespecified inclusion criteria. Overall, there was no significant difference in freedom from atrial fibrillation at ≥12-month follow-up between those receiving cryoballoon and radiofrequency ablation, respectively (OR = 0.98, CI = 0.67–1.43, I2 = 56%, p=0.90). Additionally, the secondary outcomes of duration of ablation, fluoroscopy time, and ablation time failed to reach significance. Cryoballoon ablation had significantly greater odds of postoperative phrenic nerve injury at 12-month follow-up. Conclusions. Our meta-analysis suggests that cryoballoon ablation provides comparable benefits with regard to freedom from atrial fibrillation at medium-term follow-up, fluoroscopy time, ablation time, operative duration, and overall complication rate in comparison to radiofrequency ablation.


2014 ◽  
Vol 41 (2) ◽  
pp. 129-134 ◽  
Author(s):  
Giulio Conte ◽  
Carlo de Asmundis ◽  
Giannis Baltogiannis ◽  
Giacomo Di Giovanni ◽  
Giuseppe Ciconte ◽  
...  

2021 ◽  
Vol 8 ◽  
Author(s):  
Florian Straube ◽  
Janis Pongratz ◽  
Alexander Kosmalla ◽  
Benedikt Brueck ◽  
Lukas Riess ◽  
...  

Background: Cryoballoon ablation is established for pulmonary vein isolation (PVI) in paroxysmal atrial fibrillation (AF). The objective was to evaluate CBA strategy in consecutive patients with persistent AF in the initial AF ablation procedure.Material and Methods: Prospectively, patients with symptomatic persistent AF scheduled for AF ablation all underwent cryoballoon PVI. Technical enhancements, laboratory management, safety, single-procedure outcome, predictors of recurrence, and durability of PVI were evaluated.Results: From 2007 to 2020, a total of 1,140 patients with persistent AF, median age 68 years, underwent cryoballoon ablation (CBA). Median left atrial (LA) diameter was 45 mm (interquantile range, IQR, 8), and Congestive heart failure, Hypertension, Age ≥75 years (doubled), Diabetes mellitus, prior Stroke or TIA or thromboembolism (doubled), Vascular disease, Age 65 to 74 years, Sex category (CHA2DS2-VASc) score was 3. Acute isolation was achieved in 99.6% of the pulmonary veins by CBA. Median LA time and median dose area product decreased significantly over time (p < 0.001). Major complications occurred in 17 (1.5%) patients including 2 (0.2%) stroke/transitory ischemic attack (TIA), 1 (0.1%) tamponade, relevant groin complications, 1 (0.1%) significant ASD, and 4 (0.4%) persistent phrenic nerve palsy (PNP). Transient PNP occurred in 66 (5.5%) patients. No atrio-esophageal fistula was documented. Five deaths (0.4%), unrelated to the procedure, occurred very late during follow-up. After initial CBA, arrhythmia recurrences occurred in 46.6% of the patients. Freedom from atrial arrhythmias at 1-, and 2-year was 81.8 and 61.7%, respectively. Independent predictors of recurrence were LA diameter, female sex, and use of the first cryoballoon generation. Repeat ablations due to recurrences were performed in 268 (23.5%) of the 1,140 patients. No pulmonary vein (PV) reconduction was found in 49.6% of the patients and 73.5% of PVs. This rate increased to 66.4% of the patients and 88% of PVs if an advanced cryoballoon was used in the first AF ablation procedure.Conclusion: Cryoballoon ablation for symptomatic persistent AF is a reasonable strategy in the initial AF ablation procedure.


2021 ◽  
Vol 42 (Supplement_1) ◽  
Author(s):  
G Zucchelli ◽  
K.R.J Chun ◽  
S Kaur Khelae ◽  
C Foldesi ◽  
F.J Kueffer ◽  
...  

Abstract Background Recent trials demonstrated the safety and efficacy of cryoballoon ablation prior to antiarrhythmic drug (AAD) usage in patients with paroxysmal atrial fibrillation (AF); however, global utilization and outcomes of first-line cryoablation in real-world AF patient management are unknown. Purpose To evaluate baseline characteristics and outcomes in patients selected for first-line cryoablation for treatment of AF. Methods The Cryo Global Registry (NCT02752737) is an ongoing, prospective, multicenter registry. In this analysis, AF patients with an index cryoballoon ablation performed according to local standards of care at 58 centers in 26 global countries were included. Subjects with no prior failed antiarrhythmic drug (AAD) usage and not taking an AAD at baseline were considered first-line and compared to drug-refractory patients who had failed an AAD prior to enrollment in the study and/or were taking an AAD at baseline. Baseline characteristics, serious procedure-related complication rates, and 12-month freedom from a ≥30sec AF/atrial flutter (AFL)/atrial tachycardia (AT) recurrence after a 90-day blanking period were compared between the groups. Results In total, 31% of the 1,394 patients (433 first-line, 961 drug-refractory) received a first-line cryoablation. The proportion of first-line enrollments by world region (3.7%-53.5%) and countries within region (i.e. EU: 0–59%) varied widely. Drug-refractory patients failed a mean of 1.2±0.5 AADs prior to cryoablation. First-line and drug-refractory patients were similar in age (60±13 vs 61±11), sex (35.1% vs 36.8% female), and CHA2DS2-VASC (2.0±1.6 vs 2.1±1.6). First-line was more often paroxysmal AF (87.3% vs 80.2%), with lower BMI (27±5 vs 28±5), diagnosed with AF fewer years (2.1±3.9 vs 3.7±5.0), and had smaller left atrial diameters (39±7 vs 42±8 mm; all p<0.05). Hypertension and history of congestive heart failure were less common in first-line (p<0.05), but similar rates of prior myocardial infarction, stroke, coronary artery disease, diabetes, and sleep apnea were reported. Procedure, left atrial dwell, and cryoapplication times were similar between cohorts (all p>0.05). Serious adverse event rates were not statistically different between first-line and drug-refractory patients (2.3% vs 3.4%, respectively; p=0.32). Freedom from AF/AFL/AT after cryoablation in first-line vs drug-refractory PAF was 90.0% (95% CI: 86.4–92.7%) and 84.4% (95% CI: 81.5–86.8%) and in first-line vs drug-refractory persistent AF was 72.9% (95% CI: 58.6–83.0%) vs 70.2% (95% CI: 62.9–76.4%), respectively. First-line ablation resulted in higher rates of freedom from arrhythmia recurrence (p=0.02). Conclusion First-line cryoablation in a real-world setting resulted in improved efficacy without increasing the risk of a safety event. These data support cryoablation as an early intervention strategy for treatment of AF. FUNDunding Acknowledgement Type of funding sources: Private company. Main funding source(s): Medtronic, Inc.


2016 ◽  
Vol 157 (22) ◽  
pp. 849-854 ◽  
Author(s):  
Zsófia Nagy ◽  
Zsuzsanna Kis ◽  
Zoltán Som ◽  
Csaba Földesi ◽  
Attila Kardos

Introduction: Contact force sensing radiofrequency ablation and the new generation cryoballoon ablation are prevalent techniques for the treatment of paroxysmal atrial fibrillation. Aim: The authors aimed to compare the procedural and 1-year outcome of patients after radiofrequency and cryoballoon ablation. Method: 96 patients with paroxysmal atrial fibrillation (radiofrequency ablation: 58, cryoballoon: 38 patients; 65 men and 31 women aged 28–70 years) were enrolled. At postprocedural 1, 3, 6 and 12 months ECG, Holter monitoring and telephone interviews were performed. Results: Procedure and fluorosocopy time were: radiofrequency ablation, 118.5 ± 15 min and 15.8 ± 6 min; cryoballoon, 73.5 ± 16 min (p<0.05) and 13.8 ± 4.,1 min (p = 0.09), respectively. One year later freedom from atrial fibrillation was achieved in 76.5% of patients who underwent radiofrequency ablation and in 81% of patients treated with cryoballoon. Temporary phrenic nerve palsy occurred in two patients and pericardial tamponade developed in one patient. Conclusions: In this single center study freedom from paroxysmal atrial fibrillation was similar in the two groups with significant shorter procedure time in the cryoballoon group. Orv. Hetil., 2016, 157(22), 849–854.


2021 ◽  
Vol 42 (Supplement_1) ◽  
Author(s):  
J Michaelsen ◽  
U Parade ◽  
H Bauerle ◽  
K.-D Winter ◽  
U Rauschenbach ◽  
...  

Abstract Background Pulmonary vein isolation (PVI) using cryoballoon ablation (CBA) has become an established and widespread procedure for the treatment of symptomatic paroxysmal and persistent atrial fibrillation (AF). The safety and efficacy of PVI at low and medium volume hospitals is unknown. Aim To determine safety and acute efficacy of PVI using CBA performed at community hospitals with limited annual case numbers. Methods This registry study prospectively included 1004 consecutive patients who underwent PVI with CBA for symptomatic paroxysmal (n=563) or persistent AF (n=441) between 01/2019 and 09/2020 at 20 community hospitals (each performing &lt;100 PVI/year). Qualifying criteria for participating hospitals were an experience of performing CBA for at least 1 year and a minimum of 50 CBA performed up to the start of the registry. All CBA procedures were performed according to the individual local standards of each hospital. Procedural data, acute efficacy and complications were determined. Results The mean annual number of CBA procedures performed was 59±26/hospital, the mean annual number of PVI performed regardless of the method used was 70±26/center. 8/20 hospitals performed CBA only. There were 22 operators (1,1/center), in 12/20 hospitals CBA was performed by an operator being board certified in invasive electrophysiology. 10/20 hospitals included &lt;60 patients/center (n=381), the centers enrolling &gt;60 patients/hospital included a total of 623 pts (62%). Mean procedure time was 90.1±31.6 min, mean fluoroscopy time was 19.2±11.4 min. Isolation of all pulmonary veins could be achieved in 97.9% of patients. Not achieving the goal of “all veins isolated” in a respective patient was mainly due to early termination of CBA procedure due to phrenic nerve palsy. Major complications occurred in 1,2% of patients: no in-hospital death (0%), clinical stroke in 2 patients (0.2%), pericardial effusion requiring pericardial drainage in 2 patients (0,2%), vascular complications needing vascular surgery and/or blood transfusion in 2 patients (0,2%), phrenic nerve palsy persisting up to hospital discharge in 6 patients (0,6%). Minor complications occurred in 7,5% of patients: pericardial effusion with no need of intervention in 0,4%, access site complications with no need for therapeutic intervention or prolonged in-hospital stay in 2,1% (mainly superficial hematoma) and phrenic nerve palsy resolving before discharge in 4,2%. No significant difference in the number of complications could be found when testing for numbers of enrolled patients (&gt; or &lt; than 60/hospital) or regarding the board certification status of the operator. Conclusions PVI for paroxysmal or persistent AF using CBA can be performed at community hospitals with high acute efficacy and low complication rates despite low and moderate annual procedure numbers. FUNDunding Acknowledgement Type of funding sources: None.


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