scholarly journals Zero-Fluoroscopy Cardiac Ablation: Technology Is Moving Forward in Complex Procedures—A Novel Workflow for Atrial Fibrillation

Biology ◽  
2021 ◽  
Vol 10 (12) ◽  
pp. 1333
Author(s):  
Matteo Bertini ◽  
Graziella Pompei ◽  
Paolo Tolomeo ◽  
Michele Malagù ◽  
Alessio Fiorio ◽  
...  

Background and Rationale. A fluoroscopy-based approach to an electrophysiological procedure is widely validated and has been recognized as the gold standard for a long time. The use of fluoroscopy exposes both the healthcare staff and the patient to a non-negligible dose of radiation. To minimize the risks associated with the use of fluoroscopy, it would be reasonable to perform ablation procedures with zero fluoroscopy. This approach is widely used in simple ablation procedures, but not in complex procedures. In atrial fibrillation (AF) ablation procedures, fluoroscopy remains the main technology used, in particular to guide the transseptal puncture. Main results and Implications. We present a workflow to perform a complete zero-fluoroscopy ablation for AF ablation procedures using a 3D electro-anatomical mapping system, intracardiac echocardiography and a novel steerable guiding sheath that can be visualized on the mapping system. We present two cases, one with paroxysmal AF and the other one with persistent AF during which we applied this novel workflow achieving a successful pulmonary vein isolation without complications and complete zero-fluoroscopy exposure.

2021 ◽  
Vol 2021 ◽  
pp. 1-6
Author(s):  
Fei Hang ◽  
Liting Cheng ◽  
Zhuo Liang ◽  
Ruiqing Dong ◽  
Xinlu Wang ◽  
...  

Aims. 3D electroanatomical mapping combined with intracardiac echocardiography- (EAM-ICE-) guided transseptal puncture has been proven safe and effective during the radiofrequency catheter ablation (RFCA) procedure used to treat paroxysmal atrial fibrillation (PAF). In this study, we aimed to compare the curative effect and safety of RFCA via F (fluoroscopy) and zero-fluoroscopy transseptal puncture guided by EAM-ICE in patients with PAF. Methods and Results. A prospective study in which 110 patients with PAF were included and assigned to two groups was conducted. Fifty-five (50%) patients were enrolled in the EAM-ICE group, whereas the other 55 (50%) patients were enrolled in the F group. There were no significant differences in baseline characteristics between the two groups. The transseptal duration time was longer in the EAM-ICE group (19.8 ± 3.0 min vs. 8.6 ± 1.2 min, p ≤ 0.01 ); however, fluoroscopy was not used in the EAM-ICE group compared with the F group (0 mGy vs. 109.1 ± 57.9 mGy). Similarly, there was also no significant difference in the recurrence rate of atrial fibrillation between the EAM-ICE and F groups (25.5% vs. 18.2%, p = 0.356 ). Conclusion. RFCA via EAM-ICE-guided zero-fluoroscopy transseptal puncture in patients with PAF is safe and effective for long-term follow-up.


Circulation ◽  
2014 ◽  
Vol 130 (suppl_2) ◽  
Author(s):  
Luigi Di Biase ◽  
Rodney Horton ◽  
Chintan Trivedi ◽  
Prasant Mohanty ◽  
Sanghamitra Mohanty ◽  
...  

Introduction: Radiofrequency catheter ablation of atrial fibrillation is performed under fluoroscopic guidance and therefore carries radiation risk exposure for the both the patient and the operator. Three-dimensional mapping systems and newer technologies to allow non-fluoroscopic catheter visualization together with intracardiac echo have reduced but not abolished the fluoroscopy exposure. We aim to demonstrate the feasibility, the safety and the efficacy of catheter ablation for atrial fibrillation without the use of fluoroscopy. Methods: A totally fluoro-less approach was developed for AF ablation at our Institution. 94 consecutive AF patients underwent zero fluoroscopy catheter ablation for atrial fibrillation. In the zero fluoroscopy cases, the fluoroscopy arm was kept far away from the patient table. Access including double trans-septal, mapping with the Carto 3 system and ablation were all performed without fluoroscopy with the use of ICE and the Carto 3 system. These 94 patients were compared with 94 control patients matched for age, sex and type of AF who underwent AF ablation by the same operator with the use of fluoroscopy. Results: Baseline characteristics were similar between fluoroless (N=94, Age=64.5 ± 10.1, 75.5% male, 48% paroxysmal) and control (N=94, Age=65.1 ± 9.9, 72.3% male, 50% paroxysmal) group. Non-PV triggers were detected and ablated in 51 (54.3%) and 56 (59.6%) patients in fluoroless and control group respectively (p=0.5). Average fluoro time in control group was 10.1 ± 4.7 minutes. Procedure duration was comparable (120.4 ± 25.8 vs. 122.2 ± 28.7, p =0.6). After the short term median follow-up of 4.5 (4 – 6.5) months, 10 (10.6 %) patients in flourless and 9 (9.6%) patients in control group experienced recurrences (p=0.8).One pericardial effusion requiring pericardiocenteis occurred in the fluoroless group. Conclusions: Our series show that zero fluoroscopy ablation of atrial fibrillation with the use of newer technologies is feasible, safe and efficacious at the short term follow up. Importantly in our series the double transeptal was performed without fluoroscopy and the ablation was not limited to the pulmonary veins only but included ablation of the posterior wall, the coronary sinus and the left atrial appendage.


2019 ◽  
Vol 40 (Supplement_1) ◽  
Author(s):  
R Tilz ◽  
C L Lenz ◽  
P S Sommer ◽  
N Sawan ◽  
R Meyer-Saraei ◽  
...  

Abstract Background Based on the assumption of trigger elimination, pulmonary vein isolation (PVI) currently presents the gold standard of atrial fibrillation (AF) ablation. Recently, rapidly spinning rotors or focal impulse formation has been raised as a crucial sustaining mechanism of AF. Ablation of these rotors may potentially obviate the need for trigger elimination with PVI. Purpose This study sought to compare the safety and effectiveness of Focal Impulse and Rotor Modulation (FIRM) guided catheter ablation only with the gold standard of pulmonary vein isolation (PVI) in patients with paroxysmal AF. Methods This was a post-market, prospective, single-blinded, randomized, multi-center trial. Patients were enrolled at three centers and equally (1:1) randomized between those undergoing conventional RF ablation with PVI (PVI group) vs. those treated with FIRM-guided RF ablation without PVI (FIRM group). Data was collected at enrollment, procedure, and at 7-day, 3-month, 6-month, and 12-month follow-up visits. The study was closed early by the sponsor. At the time of study closure, any pending follow-up visits were waived. Results From February 2016 until February 2018, a total of 51 (out of a planned 170) patients (mean age 63±10.6 years, 57% male) were enrolled and randomized. Four patients withdrew from the study prior to treatment, resulting in 23 patients allocated to the FIRM group and 24 in the PVI group. Only 13 patients in the FIRM group and 11 patients in the PVI group completed the 12-month follow-up. Statistical analysis was not completed given the small number of patients. Single-procedure effectiveness (freedom from AF/atrial tachycardia recurrence after blanking period) was 52.9% (9/17) in the FIRM group and 85.7% (12/14) in the PVI group at 6 months; and 31.3% (5/16) in the FIRM group and 80% (8/10) in the PVI group at 12 months. Repeat procedures were performed in 45.8% (11/24) patients in the FIRM group and 7.4% (2/27) in the PVI group. The acute safety endpoint [freedom from procedure-related serious adverse events (SAE)] was achieved in 87% (20/23) of FIRM group patients and 100% (24/24) of PVI group patients. Procedure related SAEs occurred in three patients in the FIRM group: 1 femoral artery aneurysm and 2 injection site hematomas. No additional procedure-related SAEs were reported >7 days post-procedure. Conclusions These partial study effectiveness results reinforce the importance of PVI in paroxysmal atrial fibrillation patients and suggest that FIRM-guided ablation alone (without PVI) is not an effective strategy for treatment of paroxysmal AF in most patients. Further study is needed to understand the effectiveness of adding FIRM-guided ablation as an adjunct to PVI in this patient group. Acknowledgement/Funding Abbot


2018 ◽  
Vol 4 (12) ◽  
pp. 1647-1648 ◽  
Author(s):  
Silvia Guarguagli ◽  
Ilaria Cazzoli ◽  
Aleksander Kempny ◽  
Michael A. Gatzoulis ◽  
Sabine Ernst

2021 ◽  
Author(s):  
Ioan-Alexandru Minciuna ◽  
Mihai Puiu ◽  
Gabriel Cismaru ◽  
Radu Roșu ◽  
Raluca Tomoaia ◽  
...  

Aims: Intracardiac echocardiography (ICE) is a relatively young technique used during complex electrophysiology proce-dures, such as atrial fibrillation (AF) ablation. The aim of this study was to assess whether the use of ICE modifies the radia-tion exposure at the beginning of the learning curve in AF ablation. Materials and methods: In this retrospective study, 52 patients, in which catheter ablation for paroxysmal or persistent AF was performed, were included. For 26 patients we used ICE guidance together with fluoroscopy, whereas for the remaining 26 patients we used fluoroscopy alone, all supported by electroanatomical mapping. We compared total procedure time and radiation exposure, including fluoroscopy dose and time between the two groups and along the learning curve. Results: Most of the patients included were suffering from paroxysmal AF (40, 76%), pulmonary vein isolation being performed in all patients, without secondary ablation sites. The use of ICE was associated with a lower fluoroscopy dose (11839.60±6100.6 vs. 16260.43±8264.5 mGy, p=0.041) and time (28.00±12.5 vs. 42.93±12.7 minutes, p=0.001), whereas the mean procedure time was similar between the two groups (181.54±50.3 vs 197.31±49.8 minutes, p=0.348). Radiation exposure was lower in the last 9 months compared to the first 9 months of the study (p<0.01), decreasing gradually along the learning curve. Conclusions: The use of ICE lowers radiation exposure in AF catheter ablation from the beginning of the learning curve, without any difference in terms of acute safety or efficacy. Aware-ness towards closest to zero radiation exposure during electrophysiology procedures should increase in order to achieve better protection for both patient and medical staff.


Author(s):  
Keiko Shimamoto ◽  
Kennichiro Yamagata ◽  
Akinori Wakamiya ◽  
Nobuhiko Ueda ◽  
Tsukasa Kamakura ◽  
...  

Introduction: Utilizing a 3-dimensional (3-D) mapping system and intracardiac echocardiography (ICE) has allowed ablation procedures with less or without fluoroscopy; however, there is limited data for patients with cardiac electronic implantable device (CIED) leads regarding the suspected risk of lead injury. Therefore, we sought to explore technics to perform safe trans-septal approach and catheter manipulation technique in patients with CIED leads. Methods and Results: This study comprised 68 consecutive patients (45 [66.2%] males, median [interquartile range] 73 [68–77] years old) with CIED who underwent catheter ablation for supraventricular tachycardia, 16 without fluoroscopy (zero-fluoro group) and 52 with fluoroscopy (conventional-fluoro group), between July 2019 and April 2021. All procedures were performed under a 3-D mapping system and ICE guidance. We compared the differences in treatment and development of complications between the two groups. The procedures were mainly atrial fibrillation (73.6%) and atrial tachycardia. The median time from venipuncture to trans-septal procedure (zero-fluoro vs. conventional-fluoro group: 27.0 min vs. 23.5 min, P=0.71) and total procedure time (215 min vs. 172 min, P=0.55) were not different between the two groups. The acute procedural success rate (100% vs. 98.1%, P=1.00) and reduction of atrial high-rate episodes at 6 months (3.2 [0.3–93.9]% vs. 1.0 [0.0–14.9]%, P=0.33) did not differ between the two groups. No patient showed lead-related complications in both groups. Conclusions: Zero-fluoro ablation for supraventricular arrhythmia using 3-D mapping and ICE in patients with CIED leads was feasible under careful catheter manipulation.


Author(s):  
yi he chen ◽  
Liangguo Wang ◽  
Xiaodong Zhou ◽  
ying fang ◽  
Lan Su ◽  
...  

Background: Simultaneous atrial fibrillation (AF) catheter ablation and left atrial appendage closure (LAAC) is sometimes recommended for both rhythm control and stroke prevention. However, the advantages of intracardiac echocardiography (ICE) guidance for this combined procedure have been scarcely reported. To evaluate the clinical outcomes and safety of ICE guided LAAC within a zero-fluoroscopy catheter ablation procedure. Methods and Results:From April 2019 to April 2020, 56 patients with symptomatic AF underwent concomitant catheter ablation and LAAC. ICE with a multi-angled imaging protocol mimicking the TEE echo windows was used to guide LAAC. Successful radiofrequency catheter ablation and LAAC was achieved in all patients. Procedure-related adverse event rate was 3.6%. During the 12-month follow-up, 77.8% of patients became free of arrhythmia recurrences and oral anticoagulants were discontinued in 96.4% of patients. No ischemic stroke occurred despite two cases of device-related thrombosis versus an expected stroke rate of 4.8% based on the CHA2DS2-VASc score. The overall major bleeding events rate was 1.8%, which represented a relative reduction of 68% versus an expected bleeding rate of 5.7% based on the HAS-BLED score of the patient cohort. The incidence of iatrogenic atrial septal defect secondary to a single transseptal access dropped from 57.9% at 2 months to 4.2% at 12 months TEE follow-up. Conclusion:The combination of catheter ablation and LAAC under ICE guidance was safe and effective in AF patients with high stroke risk. ICE with our novel protocol was technically feasible for comprehensive and systematic assessment of device implantation.


2020 ◽  
Vol 2020 ◽  
pp. 1-8 ◽  
Author(s):  
Silvia Guarguagli ◽  
Ilaria Cazzoli ◽  
Aleksander Kempny ◽  
Michael A. Gatzoulis ◽  
Sabine Ernst

Introduction. Transseptal puncture (TSP) is a routine access route in patients with left-sided ablation substrates and is performed safely on fluoroscopy (+/− echocardiographic guidance). We report on our experience using a radiofrequency (RF) needle in an unselected group of patients to demonstrate safety and usefulness of direct tip visualization on the 3D electroanatomical mapping (EAM) system with specific emphasis on total radiation exposure. Methods and Results. We retrospectively reviewed 42 consecutive left-sided ablation procedures with TSP performed using an RF needle guided by fluoroscopy and/or EAM visualization by a single operator. The procedures included atrial fibrillation (n = 33), atrial tachycardia (n = 8), and ventricular tachycardia (n = 1) ablations. Fourteen of 41 patients had congenital heart disease, including 9 patients with previous septal closure. Twenty-two patients had at least one previous TSP. All TSPs were performed successfully and without complications. The overall median fluoroscopy time amounted to 3.2 min and median exposure of 199.5 µGy∗m2. In a subgroup of patients (n = 27), the RF needle was visualized on the EAM system: median radiation time was 0.88 (interquartile range: 0–3.4) min and median exposure 33.5 [0–324.8] µGy∗m2. Conclusions. TSP using an RF needle is an effective technique, also in congenital patients with artificial patch material and in normal patients with multiple previous TSPs. Moreover, the RF needle tip visualization on EAM allows a low (or even zero) fluoroscopy approach.


2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
Y Furukawa ◽  
T Watanabe ◽  
T Yamada ◽  
T Morita ◽  
S Tamaki ◽  
...  

Abstract Introduction Cather ablation (CA) has been identified as an effective and safe treatment option for patients with atrial fibrillation (AF). One of the serious complications associated AF is cerebral infarction (CI). Recent studies reported that CA was associated with lower incidence of ischemic stroke in patients with AF. However, CA for AF itself has a potential risk of CI. Several previous studies showed that the incidence of silent CI (SCI) assessed by magnetic resonance imaging (MRI) of the brain occurred 5 to 18% during CA for AF. Recently, CA for AF made a remarkable progress in technology. However, there are few information available that the impact of 3-dimensional electroanatomical mapping system on the incidence of SCI. This study aimed to clarify the prevalence and predictors of SCI during CA for AF. Methods We enrolled 893 consecutive patients (male 534, age 71±10 years), who underwent CA for AF and MRI of brain 1 day after the procedure. We collected patients data such as physical examinations, blood sampling, echo cardiography, and CA data. A brain MRI was performed the next day following the procedure to identify any CIs. One-hundred and forty-six of patients used the Rhythmia® mapping system catheter, and the other mapping system such as CARTO or EnSite system used in the remaining 747 patients. Results The MRI depicted acute micro-CIs in 144 (16%) patients, but neither symptoms nor abnormal neurological findings were present in these patients. Patients with SCI had significantly higher prevalence of persistent AF (60 vs 43%, p=0.0002), CHADS2 Score (2 (1–3) vs 1 (1–2), p=0.0001), higher prevalence of previous stroke (19 vs 12%, p=0.02), larger left atrial (LA) diameter (43.2±6.4 vs 41.7±6.5mm, p=0.01), lower left ventricular ejection fraction (LVEF) (59.0±13.2 vs 64.2±11.3%, p≤0.0001), higher B-type natriuretic peptide level (221±236 vs 163±225 pg/dl, p≤0.0001), more Rhythmia® mapping system use (30 vs 8%, p&lt;0.0001), and longer procedure time (129±46 vs 108±39 min, p≤0.0001) than those without SCI, while there were no significant differences in age, LA appendage flow velocity, kind of anti-coagulant agent between the two groups. Multivariate regression analysis identified Rhythmia® use [odds ratio (OR) 4.26, (95% CI 2.32–7.84), p=0.0001], LVEF (OR 1.02, p=0.0059), CHADS2 score (OR 1.27, p=0.009), and procedure time (OR 1.005, p=0.04) as independent risk factors of acute SCI during CA for AF. Conclusion Acute SCI occurred about 16% after CA for AF. Rhythmia® mapping system use exhibited a higher incidence of acute SCI after catheter ablation for AF than the other mapping system use. Rhythmia® mapping system use, LVEF, CHADS2 score, and procedure time are associated with SCI relating CA for AF. Funding Acknowledgement Type of funding source: None


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