scholarly journals Initial experience and follow up on the PolarX cryoablation system compared to the established Arctic Front cryoablation system in PVI ablations

2021 ◽  
Vol 42 (Supplement_1) ◽  
Author(s):  
L Riesinger ◽  
S R Popal ◽  
J E Bohnen ◽  
J Siebermair ◽  
E Pesch ◽  
...  

Abstract Introduction Pulmonary vein isolation (PVI) with cryoablation was shown to be comparable to radiofrequency ablation (RF) in terms of safety and outcome for patients with atrial fibrillation (AF), so that both techniques are recommended equally by the current guidelines. A new cryoablation system PolarX® was introduced in 2020. We analysed the first patients, who underwent ablation with the new system with respect to procedural and safety outcome and evaluated the freedom from arrhythmia occurrence in the first 6 months compared to patients treated with the established Arctic Front Advance® cryoablation system. Methods We included the consecutive 44 patients who underwent cryoablation with the new PolarX® cryoablation system (28mm) and 24 patients who underwent cryoablation with the established Arctic Front Advance® cryoablation system (28mm) for paroxysmal AF. We retrospectively analysed baseline characteristics, procedural- and safety data. In 5 patients of each group an additional high-density 3D-mapping was performed, evaluating the scar-area after cryoablation in both groups (figure 1A+B). After 6 months the freedom of AF (by 7d-Holter-ECG) was evaluated in both groups. Results Baseline, procedural characteristics and results are listed in table 1. Mean total procedure duration (“door-to-door-time”) was significantly shorter in the PolarX group compared to the Arctic-Front group (136±34min vs. 163±43min; p<0.05). Number of freezes required to achieve isolation of all pulmonary veins (PVs) and cumulative freezing time was comparable in both groups. Minimal achieved temperatures were significantly lower in the PolarX group vs. ArcticFront group. The scar-area analyzed by 3D-mapping post ablation did not differ in the two groups. Complication rates as well as clinical outcome (freedom from AF) were low and did not differ in the Kaplan-Meier analysis (table 1; figure 1C). Conclusion Based on these initial results, cryoablation with the PolarX cryoballoon seems to be comparably effective and safe, with a significantly shorter procedure time and significantly lower achieved temperatures. Nevertheless, future controlled trials with a longer follow-up period will be necessary to evaluate long-term effectiveness. FUNDunding Acknowledgement Type of funding sources: None.

2021 ◽  
Vol 17 (1) ◽  
pp. 81-87
Author(s):  
Erik Wissner

The cryoballoon (CB) is a popular ablation technology used for pulmonary vein isolation. The fourth-generation CB, Arctic Front Advance PRO features a 40% shorter distal tip but retains the internal design from its second-generation predecessor. The Arctic Front Advance PRO and the second-generation CB demonstrated similar thermodynamic characteristics in a computational model. Several observational and retrospective studies established the acute safety and efficacy of the Arctic Front Advance PRO. Real-time electrical isolation was observed in 75–85% of pulmonary veins targeted with the Arctic Front Advance PRO resulting in shorter fluoroscopy and procedure times.


2019 ◽  
Vol 2 (51) ◽  
pp. 4-7
Author(s):  
Agnieszka Wojdyła-Hordyńska ◽  
Jakub Baran ◽  
Paweł Derejko

The first use of cryoablation in the treatment of arrhythmia has already been described over 40 years ago [1]. Since the introduction of cryoballoon in pulmonary veins isolation in atrial fibrillation treatment, the method has started to attract a lot of interest. Over 350,000 procedures around the word were carried out only by 2018 [2]. Recently, there have been several new publications on the results of second-generation cryoballoon ablation [2, 3, 4]. In view of technology changes, and to summarize years of experience in the treatment of atrial fibrillation, the first Cryousers conference was organized, and held in 2018 in Poland. During this meeting a survey was conducted, obtaining data on the practice of atrial fibrillation treatment in 38 Polish electrophysiological centers performing cryoablation of atrial fibrillation using both balloons, Arctic Front Advance, Medtronic Inc., Minneapolis MN, and radiofrequency point by point ablation. Around 3,745 cryoballoon procedures were performed in the surveyed centers during the year preceding the survey. The survey concerned practical issues related to the qualification and preparation of patients for the procedure, its course, and the results of pulmonary veins isolation in Poland.


2022 ◽  
Vol 9 (1) ◽  
pp. 16
Author(s):  
Denise Guckel ◽  
Philipp Lucas ◽  
Khuraman Isgandarova ◽  
Mustapha El Hamriti ◽  
Leonard Bergau ◽  
...  

Cryoballoon (CB)-guided pulmonary vein isolation (PVI) represents a cornerstone in the treatment of atrial fibrillation (AF). Recently, a novel balloon-guided single shot device (POLARx, Boston Scientific) was designed. Our study aimed to compare the efficacy, safety and characteristics of the novel CB system with the established one (Arctic Front Advance (Pro), AFA, Medtronic). A total number of 596 patients undergoing CB-guided ablation for AF were included. 65 patients (65.0 ± 11.6, 31% female) undergoing PVI with the POLARx were compared to a cohort of 531 consecutive patients (63.0 ± 27.9, 25% female) treated with AFA. Acute PVI was achieved in all patients (n = 596, 100%). Total procedure duration (POLARx 113.3 ± 23.2 min, AFA 100.9 ± 21.3 min; p < 0.001) and fluoroscopy time (POLARx 10.5 ± 5.9 min, AFA 4.8 ± 3.6 min; p < 0.001) were significantly longer in the POLARx group. The POLARx balloon achieved significantly lower nadir temperatures (POLARx −57.7 ± 0.9 °C, AFA −45.1 ± 2.6 °C; p < 0.001) and a significantly higher percentage of pulmonary veins successfully isolated with the first freeze (p = 0.027 *). One major complication occurred in the POLARx (2%) and three (1%) in the AFA group. Both ablation systems are comparably safe and effective. AF ablation utilizing the POLARx system is associated with longer procedure and fluoroscopy times as well as lower nadir temperatures.


2019 ◽  
Vol 40 (Supplement_1) ◽  
Author(s):  
C H Heeger ◽  
A Pott ◽  
C Sohns ◽  
A Rillig ◽  
M Kuniss ◽  
...  

Abstract Background Second-generation cryoballoon (CB2) based pulmonary vein isolation (PVI) has emerged as a safe and effective treatment option for symptomatic atrial fibrillation (AF). Although published complication rates of CB2 based-PVI are relatively low and several safety algorithms have been implemented in the protocols the most frequent complication is right-sided phrenic nerve injury (PNI). The reported incidence of PNI varies from 2–5% of patients. However data on PNI characteristics as well as follow-up is sparse. Purpose We aimed to evaluate the incidence, characteristics and outcome of PNI during after CB2 based-PVI in a large patients population. Methods and results From July 2012 to November 2018 a total of 13693 patients received CB2 or CB3 (third-generation) based-PVI in 23 EP centers (Germany: 12, China: 1, Turkey: 3, Japan: 3, USA: 1, Austria: 1, Poland: 1, Swizerland: 1). A total of 596 (4.4%) of patients experienced PNI during treatment of the right superior (84%) right inferior (15%) right middle (0.3%) (and left superior (0.3%) pulmonary veins. The mean time to PNI was 127±51 seconds and the mean temperature at the time of PNI was −49±7 °C. The target PV was isolated at time of PNI in 84% of cases. The applications were interrupted using double-stop technique in (71%). In 212/306 (52%) a CMAP was utilized. At the end of the procedure PNI persistent in 45% of patients. Fluoroscopic or sonographic evaluation of PNI was performed 1–3 days after the procedure and revealed persistent PNI in 35% of patients. Dyspnea before discharge was reported in 18% of patients with persistent PNI. Patients follow up at 1–3, and 6–12 months included fluoroscopy and a visit in an outpatient clinic. After 1–3 months 18% of patients showed persistent PNI including 13% of patients complaining of dyspnea. After 6–12 months of follow-up including fluoroscopic evaluation PNI was persistent in 1.8% of patients while dyspnea was reported by 1.7% patients. Only 0.08% of the overall population of 13693 patients showed permanent and symptomatic PNI. Conclusion The incidence of PNI during CB2-based PVI is low. About 55% of PNI recovered until the end of the procedure. Most of PNI recovered within 12 months. Symptomatic permanent PNI is very rare in patients after CB2/CB3-based PVI.


Author(s):  
Antonio Bisignani ◽  
Luigi Pannone ◽  
Vincenzo Miraglia ◽  
Juan Sieira ◽  
Saverio Iacopino ◽  
...  

Introduction: Left atrial posterior wall isolation (LAPWI) is often performed in addition to pulmonary vein isolation (PVI) to improve outcome in patients with persistent atrial fibrillation (AF). In this setting, LAPWI + PVI using cryoballoon ablation had comparable results with radiofrequency ablation (RFA). The aim of the study is to evaluate the feasibility and safety of a new cryoballoon ablation system in PVI + LAPWI isolation, comparing it with the historical platform. Methods: The study was a prospective, non-randomized, single center study. Forty consecutive patients, undergoing PVI + LAPWI with the novel POLARx™, were compared to 40 consecutive patients who underwent the same procedure with the established Arctic Front Advance PRO™. Results: Acute isolation was achieved in all PVs in both groups and LAPWI was achieved in 38 patients (95%) in the POLARx group and in 36 patients (90%) in Arctic Front group. Procedural outcomes were similar between the two groups, except for lower temperatures during cryoapplications in the POLARx group, for both PVI and LAPWI. The complication rate was low and similar between groups. Conclusion: LAPWI+PVI with the novel POLARx™ Cryoballoon is feasible and safe; the results are comparable with the Arctic Front Advance PRO™ system.


Blood ◽  
2012 ◽  
Vol 119 (4) ◽  
pp. 949-956 ◽  
Author(s):  
Tal Schechter ◽  
Adam Kirton ◽  
Suzanne Laughlin ◽  
Ann-Marie Pontigon ◽  
Yaron Finkelstein ◽  
...  

Abstract Pediatric arterial ischemic stroke (AIS) is increasingly diagnosed and carries significant risks of recurrence, morbidity, and mortality. Anticoagulant therapy (ACT) is commonly prescribed in childhood AIS. Hemorrhagic complication rates in pediatric stroke are unknown, and adult safety data are of limited applicability. We analyzed a prospectively enrolled cohort of children (aged 1 month-18 years) with acute AIS selected using standardized criteria for protocol-based ACT over14-year period. We assessed ACT-associated intracranial hemorrhage (ICH), including frequency, clinical and radiologic characteristics, predictors, and outcome. Among 215 children with AIS, 123 received ACT within 7 days after diagnosis. During anticoagulation, 14 (11%) children developed new or increased ICH, all within 26 days from diagnosis. ICH was symptomatic in 5 (4%), asymptomatic in 9 (7%), and mild (European Cooperative Acute Stroke Study grades HI1 or HI2) in all but 1 child (ECASS PH-2). Long-term neurologic outcomes after ACT-associated ICH in survivors were abnormal in 73% (8/11). Comparably, 12 of 75 (16%) children treated without anticoagulation developed new or increased ICH on follow-up imaging (P = .3507). We conclude that ACT is relatively safe in children with AIS, with a 4% risk of symptomatic ICH. Based on the safety of ACT in our study, clinical trials of ACT in childhood AIS are warranted.


2015 ◽  
Vol 95 (1) ◽  
pp. 44-49 ◽  
Author(s):  
Maria Angela Cerruto ◽  
Carolina D'Elia ◽  
Francesca Maria Cavicchioli ◽  
Stefano Cavalleri ◽  
Matteo Balzarro ◽  
...  

Background: Pelvic organ prolapse is a common condition, affecting about 50% of women with children. The aim of our study was to evaluate results and complication rates in a consecutive series of female patients undergoing robot-assisted laparoscopic hysterosacropexy (RALHSP). Materials and Methods: We performed a medical record review of female patients with uterine prolapse who had consecutively undergone RALHSP from February 2010 to 2013 at our department. Results: Fifteen patients were included in the analysis. All patients had uterine prolapse stage ≥II and urodynamic stress urinary incontinence. The mean age was 58.26 years. According to the Clavien-Dindo system, 4 out of 15 patients (26.6%) had grade 1 early complications and 1 patient had a grade 2 complication. At a median follow-up of 36 months, there was a significant prolapse relapse rate of 20% (3/15). Conclusion: In our hands RALHSP is easy to perform, with satisfying mid-term outcomes and a low complication rate.


Author(s):  
Antonio Creta ◽  
Viijayabharathy Kanthasamy ◽  
Richard J. Schilling ◽  
James Rosengarten ◽  
Fakhar Khan ◽  
...  

Author(s):  
Eitan Podgaetz ◽  
Vani Konda

Abstract Objective With the advent of minimally invasive surgery, incisionless surgery, and third-space endoscopy, the treatment for Zenker's diverticulum has also moved toward less invasive techniques Methods New incisionless per oral techniques can be applied for cricopharyngeal myotomy in Zenker's diverticulum. Results Five patients underwent Zenker's diverticulum per oral endoscopic myotomy (Z-POEM) without complications, minimal discomfort, and narcotic consumption, with complete resolution of their symptoms by history and Eckardt scores. Conclusions Z-POEM is performed entirely endoscopically with very little associated pain or complication rates, with short-term follow-up having excellent functional and symptomatic results.


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