SmartTouch Catheter Research Articles

Radiofrequency ablation using the ThermoCool SmartTouch Catheter guided by ablation index versus antiarrhythmic drugs in atrial fibrillation treatment in China: a cost-consequence analysis.

Aim: To evaluate the costs and consequences of two front-line atrial fibrillation (AF) treatments from Chinese healthcare system perspective: radiofrequency catheter ablation (RFCA) using ThermoCool SmartTouch Catheter guided by Ablation Index (STAI), in comparison to antiarrhythmic drugs (AADs). Patients & methods: We simulated clinical and economic consequences for AF patients initially receiving STAI or AADs using a short-term decision tree model leading to a 10-year long-term Markov model. The model projected both clinical consequences and costs associated with, among others, AF, heart failure (HF), strokes, and deaths due to AF or AF related complications. Data informing the models included combination of a local real-world study and published clinical studies. Results: STAI was advantageous versus AADs on all 4 main clinical outcomes evaluated; AF: 25.83% lower (12.84% vs 38.67%), HF: 2.22% lower (1.33% vs 3.55%), stroke or post stroke: 1.82% lower (10.00% vs 11.82%)and deaths due to AF or AF related complications: 0.64% lower (4.11% vs 4.75%). The average total cost per patient in STAI group was ¥16,682 lower (¥123,124 vs ¥139,806). The one-way sensitivity analysis indicated that the difference in total cost was most sensitive to annual AF recurrence probability in AADs-treated patients. Probabilistic sensitivity analysis indicated a 98.5% probability that RFCA treatment would result in cost savings by the end of the 10th year. Conclusion: Radiofrequency catheter ablation using SmartTouch catheter guided by Ablation Index was superior to AADs as the first-line AF treatment in Chinese setting with better clinical outcomes and at lower costs over a 10-year time horizon.

Impact of high-power short-duration atrial fibrillation ablation technique on the incidence of silent cerebral embolism: a prospective randomized controlled study

BackgroundHigh-power short-duration (HPSD) ablation strategy has emerged as a popular approach for treating atrial fibrillation (AF), with shorter ablation time. The utilized Smart Touch Surround Flow (STSF) catheter, with 56 holes around the electrode, lowers electrode-tissue temperature and thrombus risk. Thus, we conducted this prospective, randomized study to investigate if the HPSD strategy with STSF catheter in AF ablation procedures reduces the silent cerebral embolism (SCE) risk compared to the conventional approach with the Smart Touch (ST) catheter.MethodsFrom June 2020 to September 2021, 100 AF patients were randomized 1:1 to the HPSD group using the STSF catheter (power set at 50 W) or the conventional group using the ST catheter (power set at 30 to 35 W). Pulmonary vein isolation was performed in all patients, with additional lesions at operator’s discretion. High-resolution cerebral diffusion-weighted magnetic resonance imaging (hDWI) with slice thickness of 1 mm was performed before and 24–72 h after ablation. The incidence of new periprocedural SCE was defined as the primary outcome. Cognitive performance was assessed using the Montreal Cognitive Assessment (MoCA) test.ResultsAll enrolled AF patients (median age 63, 60% male, 59% paroxysmal AF) underwent successful ablation. Post-procedural hDWI identified 106 lesions in 42 enrolled patients (42%), with 55 lesions in 22 patients (44%) in the HPSD group and 51 lesions in 20 patients (40%) in the conventional group (p = 0.685). No significant differences were observed between two groups regarding the average number of lesions (p = 0.751), maximum lesion diameter (p = 0.405), and total lesion volume per patient (p = 0.669). Persistent AF and CHA2DS2-VASc score were identified as SCE determinants during AF ablation procedure by multivariable regression analysis. No significant differences in MoCA scores were observed between patients with SCE and those without, both immediately post-procedure (p = 0.572) and at the 3-month follow-up (p = 0.743).ConclusionsInvolving a small sample size of 100 AF patients, this study reveals a similar incidence of SCE in AF ablation procedures, comparing the HPSD strategy using the STSF catheter to the conventional approach with the ST catheter.Trial registrationClinicaltrials.gov: NCT04408716.Graphical AF = Atrial fibrillation, DWI = Diffusion-weighted magnetic resonance imaging, HPSD = High-power short-duration, ST = Smart Touch, STSF = Smart Touch Surround Flow.

Comparisons of procedural characteristics and clinical outcomes between SMARTTOUCH SURROUNDFLOW catheter and other catheters for atrial fibrillation radiofrequency catheter ablation: a systematic literature review

BackgroundSMARTTOUCH SURROUNDFLOW (STSF) catheter is the new generation of SMARTTOUCH (ST) catheter with an upgraded irrigation system for radiofrequency catheter ablation (RFCA) in patients with atrial fibrillation (AF).MethodsThis systematic literature...

Efficacy and safety of catheter ablation of VT using the QDOT Micro catheter: a propensity-matched dual-center comparison with the thermocool SmartTouch catheter

Abstract Funding Acknowledgements Type of funding sources: None. Background Catheter ablation is an increasingly used treatment option for patients with recurrent ventricular tachycardia (VT) or electrical storm (ES). The QDOT Micro (QDOT) Catheter (Biosense Webster) is a novel radiofrequency ablation catheter that was found to allow rapid and effective pulmonary vein isolation among patients with atrial fibrillation. There is no published data on the safety and efficacy of catheter ablation for VT using the QDOT catheter, and few data allow a direct comparison of different technologies in this setting. Purpose to assess outcomes of CA for VT among patients with structural heart disease using the QDOT catheter, and compare them to those observed with the Thermocool Smarttouch (TC-ST, Biosense Webster) catheter. Methods we conducted a dual-center, observational, prospective study enrolling patients with structural heart disease and recurrent VT/ES undergoing catheter ablation with the QDOT catheter. For comparison, we performed a 1:1 propensity score matching to identify patients who underwent VT CA with the TC-ST catheter, using the nearest neighbor method. Propensity score was based on gender, age, etiology of structural heart disease, left ventricular ejection fraction, electrical storm, and number of previous CAs for VT. The primary efficacy outcome was freedom from recurrent VT, as assessed by implantable defibrillator (ICD) interrogation; the primary safety outcome was in-hospital complications. Results Forty propensity-matched patients were included in the analysis (QDOT, n=20; TC-ST, n=20); baseline clinical characteristics are resumed in Table. After a median follow-up of 7 months, survival free from any recurrent VT measured 74 (95% CI, 57-97)% and 69 (95% CI, 51-93)% in the QDOT and TC-ST groups, respectively (log-rank p=0.54, Figure A), while survival free from ICD shocks was 95 (95% CI, 86-100)% versus 84 (95% CI, 69-100)% (log-rank p=0.26, Figure B). There were no major complications in the QDOT group, while three patients (15%) in the TC-ST had a primary safety event (p=0.23; femoral pseudoaneurysm, n=1; cardiac tamponade, n=1; aortic cusp perforation, n=1). Conclusion In a cohort of patients with structural heart disease and recurrent VT or ES, the novel QDOT ablation catheter had similar efficacy and safety compared to the TC-ST catheter. Interestingly, no major procedural complications were observed with the QDOT catheter, suggesting that this device may be safe even in most challenging patients.

Electroanatomical voltage mapping with a force-sensing technology catheter for diagnosis of Arrhythmogenic Right Ventricular Cardiomyopathy (ARVC)

Abstract Funding Acknowledgements Type of funding sources: None. Introduction Invasive three-dimensional electroanatomical mapping (EAM) can be helpful to diagnose arrhythmogenic right ventricular cardiomyopathy (ARVC). Contact force sensing catheters (CFSC) represent the gold standard to verify adequate tissue contact during EAM. However, normal reference values for right ventricular (RV) EAM as well as substrate characterization in patients with ARVC using CFSC have not been systematically investigated, which was the aim of this prospective study. Methods EAM of the RV during sinus rhythm was performed with the Thermocool SmartTouch catheter via a long sheath in the CARTO3 system in 11 patients with definite ARVC and 5 age- and gender-matched control subjects without structural heart disease. Only points with a mean contact force of ≥4G were analyzed. To account for differences due to RV anatomy, it was divided into 5 segments: RV outflow tract (RVOT), septum, free wall, sub-tricuspid region and apex. Endocardial bipolar and unipolar voltages, signal characteristics and signal duration were analyzed. The impact of catheter orientation on endocardial signals was also assessed. Results A median of 227 (IQR:120-364) endocardial RV points were analyzed. Median bipolar voltage in healthy controls was 3.8mV (range 3.6-4.6, IQR 2.7-5.4), with lower values in the RVOT and higher values in the RV septum. ARVC patients showed significantly lower bipolar voltages as compared to controls (repeated measures ANOVA; between-subjects effect: F=6.443,p=0.024), showing significantly lower bipolar voltage values in the sub-tricuspid region (1.8±1.9vs.4.6±2.9mV,p=0.031) and in the RV apex (2.9±1.4vs.7.2±5.2mV,p=0.024), Figure 1c. Bipolar voltage values in all RV regions yielded a high sensitivity and specificity for ARVC diagnosis (AUC62-78%,p<0.001 for all), with the highest performance for the sub-tricuspid region (AUC78%,95%CI0.75-0.81,p<0.001). A bipolar voltage value <1.5mV in the sub-tricuspid region yielded a sensitivity of 98% and a specificity of 53% for ARVC diagnosis (Figure 1a-b, showing the typical RV free wall "C-scar" in ARVC and normal values for the RV apex in less advanced disease stages). A positive correlation between bipolar voltage values and an orthogonal catheter orientation (46°-90°: r=0.106,p<0.001) as well as a higher catheter contact force (r=0.054,p=0.008), and a negative correlation between bipolar voltage values and QRS duration (r=-0.370,p<0.001) was found. Conclusions For the first time a systematic analysis of RV endocardial low voltage areas in ARVC patients as compared to controls by using CFSC was performed, and confirmed that RV voltages are generally lower in ARVC as compared to controls, with the sub-tricuspid area showing the lowest values and highest discriminatory power vs controls.

AB-453068-3 ESOPHAGEAL TEMPERATURE AND ESOPHAGEAL DAMAGE IN HIGH POWER SHORT DURATION ABLATION SETTINGS

Radiofrequency ablation (RFA) of atrial fibrillation (AF) using high-power short-duration (HPSD) ablation settings (50W, 10s or up to 90W, 4s) are increasingly common, seeking to maximize resistive rather than conductive heating to limit the risk of esophageal damage. The real-time luminal esophageal temperature (LET) response and the risk of esophageal damage of HPSD are not fully established. To investigate the LET and esophageal risk of HPSD RFA on the posterior LA wall. We ablated the deep inferior pulmonary vein (IPV) in close proximity to the esophagus in 14 pigs, using either Termocool SmartTouch Catheter (HPSD 50W/10s, n=7), or QDOT Catheter (HPSD 90W/4s, n=7). LET was monitored with a 12-sensor CIRCA probe. RFA was delivered in the IPV in apposition with the esophagus as verified on 3D maps. We collected LET, ablation parameters; endoscopy, macro- and microscopic examination of the esophagus. In 3 pigs in each group, survival was prolonged 1 month for chronic characterization of esophageal lesions. Total energy delivered (90W/4s vs. 50W/10s) was higher in QDOT group (60.8±18.8W vs. 48.9±0.1W, p<0.005), as was the peak temperature at ablation catheter tip (51.2±3.1°C vs. 25.3±2.8°C, p<0.005). Peak LET was lower in the 90W/4s group than in the 50W/10s group, (38.7±1.5°C vs. 40.5±3.1°C, p<0.005). Temperatures >40°C were reached in 14/90 90W/4s ablations vs 43/94 in 50W/10s ablations (p<0.001). Acute esophageal lesions were found in all pigs. In the 90W/4s group, acute lesions involved affecting outer muscularis layer in 4/4 and up to submucosa in 1/4. However, no chronic lesions were identified in 3/3. In the 50W/10s group: 4/4 acute lesions involved entire muscularis layer into the submucosa, and reaching the mucosa in 2. Chronic lesions were found in only 1 on pig in the 50W/10s group – complete muscularis layer replacement with scar (with submucosal inflammation). All lesions occurred after high LETs. (Figure) HPSD 50W/10s can create high LET and significant acute and chronic esophageal damage. QDOT catheter at 90W/4s leads to lower peak LETs, can lead to acute lesions but no chronic esophageal damage. LET can be used to monitor risk of esophageal damage in both HPSD protocols.

Safety and Effectiveness of a Catheter With Contact Force and 6-Hole Irrigation for Ablation of Persistent Atrial Fibrillation in Routine Clinical Practice

The ThermoCool SmartTouch catheter (ablation catheter with contact force and 6-hole irrigation [CF-I6]) is approved by the US Food and Drug Administration (FDA) for paroxysmal atrial fibrillation (AF) ablation and used in routine clinical practice for persistent AF ablation, although clinical outcomes for this indication are unknown. There is a need to understand whether data from routine clinical practice can be used to conduct regulatory-grade evaluations and support label expansions. To use health system data to compare the safety and effectiveness of the CF-I6 catheter for persistent AF ablation with the ThermoCool SmartTouch SurroundFlow catheter (ablation catheter with contact force and 56-hole irrigation [CF-I56]), which is approved by the FDA for this indication. This retrospective, comparative-effectiveness cohort study included patients undergoing catheter ablation for persistent AF at Mercy Health or Mayo Clinic from January 1, 2014, to April 30, 2021, with up to a 1-year follow-up using electronic health record data. Use of the CF-I6 or CF-I56 catheter. The primary safety outcome was a composite of death, thromboembolic events, and procedural complications within 7 to 90 days. The exploratory effectiveness outcome was a composite of AF-related hospitalization events after a 90-day blanking period. Propensity score weighting was used to balance baseline covariates. Risk differences were estimated between catheter groups and averaged across the 2 health care systems, testing for noninferiority of the CF-I6 vs the CF-I56 catheter with respect to the safety outcome using 2-sided 90% CIs. Overall, 1450 patients (1034 [71.3%] male; 1397 [96.3%] White) underwent catheter ablation for persistent AF, including 949 at Mercy Health (186 CF-I6 and 763 CF-I56; mean [SD] age, 64.9 [9.2] years) and 501 at Mayo Clinic (337 CF-I6 and 164 CF-I56; mean [SD] age, 63.7 [9.5] years). A total of 798 (55.0%) had been treated with class I or III antiarrhythmic drugs before ablation. The safety outcome (CF-I6 - CF-I56) was similar at both Mercy Health (1.3%; 90% CI, -2.1% to 4.6%) and Mayo Clinic (-3.8%; 90% CI, -11.4% to 3.7%); the mean difference was noninferior, with a mean of 0.5% (90% CI, -2.6% to 3.5%; P < .001). The effectiveness was similar at 12 months between the 2 catheter groups (mean risk difference, -1.8%; 90% CI, -7.3% to 3.7%). In this cohort study, the CF-I6 catheter met the prespecified noninferiority safety criterion for persistent AF ablation compared with the CF-I56 catheter, and effectiveness was similar. This study demonstrates the ability of electronic health care system data to enable safety and effectiveness evaluations of medical devices.

Procedural Efficiency, Efficacy, and Safety of High-Power, Short-Duration Radiofrequency Ablation Delivered by STSF Catheter for Paroxysmal Atrial Fibrillation.

Objectives To investigate the procedural efficiency, efficacy, and safety of high-power, short-term radiofrequency ablation delivered by the SmartTouch Surround Flow (STSF) catheter for paroxysmal atrial fibrillation (AF). Methods We retrospectively analyzed a total of 72 patients who were admitted with paroxysmal AF, and who underwent radiofrequency catheter ablation (RFCA) for the first time. Of these patients, 36 cases underwent low-power, long-duration (LPLD, (30–35 W/20–40 s) pulmonary vein isolation (PVI) delivered by an SmartTouch (ST) catheter (control group), and the other 36 cases underwent high-power, short-duration (HPSD, (45–50 W/10–20 s) PVI delivered by a STSF catheter (study group). The baseline data, duration of PVI, procedural time, fluoroscopy time, the rate of first-pass isolation, irrigation perfusion, eschar and steam pop occurrences, intraoperative complications, and the rate of stable sinus rhythm maintenance following a blanking period of three months were analyzed between the two groups. Results The isolation time of bilateral PVI and procedural time in the study group were markedly less than in controls (p < 0.01). The rate of first-pass isolation in the study group was significantly higher than in the control group (95.8% vs. 84.7%, p = 0.023), while the fluid perfusion in the study group was approximately 20% less than that in the control group (767 ± 171 vs. 966 ± 227 ml, p < 0.001). We observed no severe complications in any patients. The rate of freedom from AF recurrences following a blanking period of three months showed a tendency to be higher than in controls (93.9% vs. 87.1%, p = 0.348). Conclusions The HPSD strategy delivered by the STSF catheter was superior to conventional LPLD ablation through the ST catheter with respect to efficiency, acute procedural effectiveness, short-term safety, and the risk of heart failure in patients with paroxysmal AF.

Rationale and Study Design for Evaluating the Efficacy and Safety of Intracardiac Echocardiography-Guided Minimal-Fluoroscopy Ablation in Patients with Paroxysmal Atrial Fibrillation: A Non-Inferior, Multi-Center, Prospective Randomized Controlled Trial (PAF-ICE Trial)

Abstract The feasibility and safety of intracardiac echocardiography (ICE)-guided catheter ablation for atrial fibrillation (AF) using a minimal/zero-fluoroscopy approach have recently been reported. This approach helps to reduce ionizing radiation exposure and orthopedic complications resulting from using lead aprons. The objectives of this planned prospective, multicenter randomized controlled trial (RCT) (paroxysmal AF (PAF)-ICE trial; ChiCTR2000033624) are to evaluate the efficacy and safety of ICE-guided minimal-fluoroscopy ablation in patients with PAF and the impact on occupational hazards among lab staff. Patients will be randomized in a 1:1 ratio to 2 groups: minimal fluoroscopy group (n = 216) and traditional approach group (n = 216). In the minimal fluoroscopy group, an ICE catheter will be used for geometry/anatomic construction, transseptal puncture, catheter tracking, and effusion monitoring. Pulmonary vein isolation (PVI) will be performed using an open-irrigated radiofrequency SmartTouch Surround Flow or SmartTouch catheter (Biosense Webster, Diamond Bar, California, USA), and confirmed by a multipolar Lasso or PentaRay catheter (Biosense Webster). In the traditional approach group, an ICE catheter will not be used. Transseptal puncture will be performed under fluoroscopic guidance, with all geometries constructed by mapping the catheters. The primary efficacy endpoint is freedom from AF recurrence (without antiarrhythmic medications) at 12 months after ablation. Other endpoints include duration of lead apron use, measures of intra-procedural efficiency, and peri-procedural complications. This RCT will evaluate the efficacy and safety of ICE-guided minimal-fluoroscopy ablation in patients with PAF, also evaluate the benefits to lab staff (regarding reducing occupational hazards) related to this “minimal/zero-fluoroscopy” and “leadless” mode.

B-PO03-202 ABLATION OF ATRIAL FIBRILLATION AND FLUTTER IN ADULT CONGENITAL HEART DISEASE: PROCEDURAL ASPECTS AND OUTCOMES

Patients with ACHD have increased risk of arrhythmia due to underlying condition and prior surgeries. To assess ablation success of atrial fibrillation and flutter in ACHD. All ACHD patients who underwent EP ablation for atrial fibrillation or flutter from 12/2013 to 11/2020 were included, for a total of 46 subjects and 58 ablations. Median age was 58.0 (IQR = 41.0 - 68.0), 67.4% were male and 80.4% had prior corrective surgery. Prior to ablation, 67.4% failed an average of 1.39 antiarrhythmic drugs (AAD). Of the 58 ablations performed, 22 (37.3%) had atrial fibrillation, 21 (35.6%) had atrial flutter and 16 (27.1%) had both. At the end of procedure, acute success rate was 81.1%, with 18.9% requiring cardioversion. Twelve patients had second ablation, with total recurrence rate of 41.3%, at follow up of 38.7 +/- 23.4 months. Rate of recurrence was not significantly different among patients who had atrial fibrillation, flutter or both (χ2 = .804, p = .669). Recurrence predictors (by logistic regression) revealed use of smart touch catheter with lower rate of arrhythmia recurrence (OR = .0702, p = .014) and DCCV with higher rate (OR = 4.50, p = .027). Multielectrode mapping decreased mean RF time by 1,130 seconds (t = 2.19, p = .0338). One year after ablation, 17.4% of subjects were on AAD, for a 74.2% decrease (z = 4.56, p < .001). Four (8.7%) subjects died during the study period, ranging 103 to 1260 days after ablation. Four (8.7%) subjects required pacemaker. Atrial arrhythmia ablation is safe and recommended in patients with ACHD, reducing need for AAD. Successful ablation without arrhythmia recurrence remains a challenge.

Pattern Matching Filter and multielectrode mapping catheter - A new approach for complex premature ventricular contraction ablation.

Our goal was to assess usefulness of Pattern Matching Filter (PMF) software combined with the PentaRay catheter for complex premature ventricular contraction (PVC) ablation. A prospective observational study of consecutive patients referred for complex PVC ablation at our tertiary center from January to September 2018. Patients underwent ablation using a pre-specified mapping strategy with the PMF and the PentaRay catheter (PVCs with ≥97% correlation with the template morphology were collected). Procedural endpoints and acute and 12-months success rates were assessed and compared to a retrospective cohort of patients who also underwent a complex PVC ablation with standard activation mapping performed with a Thermocool SmartTouch catheter. During the nine-month enrollment period, seven patients fulfilled our inclusion criteria, while there were four patients in the control group. Patients treated with the PMF and PentaRay had a fivefold number of points acquired (507±213 vs. 90±62) and a halved procedure time (67±42 vs.130±54 min), required a shorter radiofrequency ablation time (294±112 vs.706±613 sec) and had a higher overall success rate (100% vs.75%) when compared to the standard approach. No major complications occurred in either group. In this first study assessing the combined use of the PentaRay catheter and the PMF for complex PVCs ablation, we demonstrate how this approach can improve the level of detail, accuracy and reliability of the activation map, while reducing the number of radiofrequency applications and procedural time. Further studies are warranted to confirm whether this approach can lead to improved outcomes.

Comparison of the lesion formation and safety in ex vivo porcine heart study: Using ThermoCool SmartTouch and ThermoCool SmartTouch-SF catheters.

The study was performed to compare the efficacy and safety during radiofrequency ablation (RFA) using ThermoCool SmartTouch (ST) and ThermoCool SmartTouch-SF (STSF) catheters in the porcine heart. RFA was performed on the porcine myocardium by using two irrigated ablation catheters. Three groups were divided based on the different contact forces (CFs): low contact force (LCF) (1-3 g), medium contact force (MCF) (5-10 g), and high contact force (HCF) (15-20 g). In each group, RFA was delivered at four power settings of 30, 40, 50, 60 W. At each power, RFA was applied to reach the target ablation index (AI) of 350, 450, and 500. Altogether, 360 RF lesions were created by using 72 ablation conditions. AI value was positively correlated with lesion size using ST and STSF catheters. At a fixed power, lesion dimensions significantly smaller in the LCF group, whereas did not differ between MCF and HCF groups. Furthermore, at a fixed CF, lesion dimensions increased with power set at 40 W compared with 30 W but decreased with high-power RF energy (50 and 60 W). Although the average lesion surface diameter and the maximum diameter was increased using the STSF catheter, there were no significant differences in LV between the two catheters. The steam pop provoked more frequently using ST catheter and showed a negative correlation with CF and positive correlation with high-power energy. The STSF catheter is safer and equally effective in lesion formation compared with the ST catheter. LV was increased along with the early increase of CF and power, whereas a further increase of CF and power significantly reduces the lesion size.

Pattern Matching Filter and multielectrode mapping catheter – A new approach for complex premature ventricular contraction ablation

PurposeOur goal was to assess usefulness of Pattern Matching Filter (PMF) software combined with the PentaRay catheter for complex premature ventricular contraction (PVC) ablation. MethodsA prospective observational study of consecutive patients referred for complex PVC ablation at our tertiary center from January to September 2018. Patients underwent ablation using a pre-specified mapping strategy with the PMF and the PentaRay catheter (PVCs with ≥97% correlation with the template morphology were collected). Procedural endpoints and acute and 12-months success rates were assessed and compared to a retrospective cohort of patients who also underwent a complex PVC ablation with standard activation mapping performed with a Thermocool SmartTouch catheter. ResultsDuring the nine-month enrollment period, seven patients fulfilled our inclusion criteria, while there were four patients in the control group. Patients treated with the PMF and PentaRay had a fivefold number of points acquired (507±213 vs. 90±62) and a halved procedure time (67±42 vs.130±54 min), required a shorter radiofrequency ablation time (294±112 vs.706±613 sec) and had a higher overall success rate (100% vs.75%) when compared to the standard approach. No major complications occurred in either group. ConclusionsIn this first study assessing the combined use of the PentaRay catheter and the PMF for complex PVCs ablation, we demonstrate how this approach can improve the level of detail, accuracy and reliability of the activation map, while reducing the number of radiofrequency applications and procedural time. Further studies are warranted to confirm whether this approach can lead to improved outcomes.

Association between left atrial wall thickness and residual potential after pulmonary vein antral isolation in patients with atrial fibrillation receiving Ablation Index-guided ablation

Abstract Background For the improvement of efficacy in radiofrequency catheter ablation (RFCA) of pulmonary vein isolation (PVI) in patients with atrial fibrillation (AF), fixed target Ablation Index (AI) value has been recommended regardless of individual and regional differences of left atrial wall thickness (LAWT). Objective To evaluate the association between LAWT and residual potential (RP) after first pass encirclement of PVI in AF patients receiving AI-guided PVI. Method A total of 116 patients (29% persistent AF) undergone AF RFCA using AI-guided PVI were included. Using SmartTouch catheter or SmartTouch SF catheter (Biosense Webster Inc., CA, US), point-by-point ablation was delivered at 30–40W on the anterior/roof segments and 25–30W on the posterior/inferior/carina segments. AI targets were 450 on the anterior/roof segments and 350 on the posterior/inferior/carina segments. After first encirclement of PVI was performed, RP was evaluated. LAWT was evaluated by 3-dimensional wall thickness map using computed tomographic images. LAWT values of ablation regions were graded by LAWT in each segment of PV antrum (Figure). Results Among a total of 1564 PV segments, RP was observed in 106 segments (6.8%). Left superior, inferior PV ridges and right superior PV roof segments were the most, second, and third thickest area among 14 PV segments (mean LAWT grade 5.09±1.08, 3.34±1.70, and 2.32±1.11, respectively). Mean LAWT grade was lower in segments with RP than those in without RP (2.74±1.80 vs. 2.07±1.28, p&amp;lt;0.001, Figure). In segments applied AI 450 (anterior/roof), segments with RP showed significantly thicker LAWT than those without RP (mean LAWT grade 3.65±2.01 vs. 2.57±1.56, p&amp;lt;0.001). In posterior/inferior/carina segments applied AI 350, there was no significant difference in mean LAWT between segments with and without RP (1.80±0.77 vs. 1.75±0.83, p=0.744). Conclusion Delivering same AI during PVI, thicker LAWT was associated with higher incidence of RP after first pass encirclement of PV in anterior/roof area. Tailored AI should be considered by LAWT to improve acute outcome of PVI. LAWP RP Funding Acknowledgement Type of funding source: None

Contact-force monitoring increases accuracy of right ventricular voltage mapping avoiding “false scar” detection in patients with no evidence of structural heart disease

PurposeElectroanatomical mapping (EAM) could increase cardiac magnetic resonance imaging (CMR) sensitivity in detecting ventricular scar. Possible bias may be scar over-estimation due to inadequate tissue contact. Aim of the study is to evaluate contact-force monitoring influence during EAM, in patients with idiopathic right ventricular arrhythmias. Methods20 pts (13 M; 43 ± 12 y) with idiopathic right ventricular outflow tract (RVOT) arrhythmias and no structural abnormalities were submitted to Smarttouch catheter Carto3 EAM. Native maps included points collected without considering contact-force. EAM scar was defined as area ≥1 cm2 including at least 3 adjacent points with signal amplitude (bipolar <0.5 mV, unipolar 3,5 mV), surrounded by low-voltage border zone. EAM were re-evaluated offline, removing points collected with contact force <5 g. Finally, contact force-corrected maps were compared to the native ones. ResultsAn EAM was created for each patient (345 ± 85 points). After removing poor contact points, a mean of 149 ± 60 points was collected. The percentage of false scar, collected during contact force blinded mapping compared to total volume, was 6.0 ± 5.2% for bipolar scar and 7.1 ± 5.9% for unipolar scar, respectively. No EAM scar was present after poor contact points removal. Right ventricular areas analysis revealed a greater number of points with contact force < 5 g acquired in free wall, where reduced mean bipolar and unipolar voltage were recorded. ConclusionsTo date this is the first work conducted on structurally normal hearts in which contact-force significantly increases EAM accuracy, avoiding “false scar” related to non-adequate contact between catheter and tissue.

Safety and efficacy of the ThermoCool SmartTouch SurroundFlow catheter for atrial fibrillation ablation: A meta-analysis.

BackgroundThe ThermoCool Smarttouch Surroundflow catheter (STSFc) is an advanced catheter, which integrating contact force sensing and surroundflow technology. However, comparative data between STSFc and contact force sensing catheter (Thermocool SmartTouch catheter [STc]) are limited.HypothesisWe thought that STSFc might bring more clinical benefits. The aim of this meta‐analysis was to compare the safety and efficiency between the STSFc and the STc for treatment of atrial fibrillation (AF).MethodsThe Medline, PubMed, Embase, and Cochrane Library databases were searched for studies comparing STSFc and STc.ResultsFour trials involving 727 patients were included in the study. Pool‐analyses demonstrated that, as compared STc ablation, STSFc ablation was more beneficial in terms of procedural times (standard mean difference [SMD]: −0.22; 95% confidence interval [CI], −0.37 to −0.07, P = .005) and irrigation fluid volume (SMD: −1.94; 95% CI, −2.65 to −1.22, P < .0001). There was no significant difference between STSFc and STc (risk ratio [RR]: 1.02; 95% CI: 0.86 to 1.21, P = .79) for free from AF. Evidence of complications were low and similar for both groups (RR: 0.83; 95% CI: 0.19‐3.55, P = .80). Additionally, patients administered STSFc ablation tended to have shorter fluoroscopic times (SMD: −0.20; 95% CI, −0.63‐0.23, P = .21).ConclusionsSTSFc ablation was associated with reducing procedural times and irrigation fluid volume. Further, STSFc ablation tended to shorten fluoroscopic times. Therefore, STSFc ablation would be a better choice for AF patients especially in patients with heart failure.

Atrial fibrillation ablation with a spring sensor-irrigated contact force-sensing catheter compared with other ablation catheters: systematic literature review and meta-analysis

ObjectivesThe objective of our review was to systematically assess available evidence on the effectiveness, safety and efficiency of a spring sensor-irrigated contact force (CF) catheter (THERMOCOOL SMARTTOUCH Catheter (ST)) for...

Cost minimization analysis of catheter ablation for paroxysmal atrial fibrillation by catheter technology.

Compare the 1-year costs of three catheter ablation technologies for the treatment of paroxysmal atrial fibrillation (PAF). A decision tree model was developed to estimate 1-year hospital costs associated with an index and potential repeat PAF ablation procedure using the Thermocool® Smarttouch® Catheter(ST), Thermocool SF Catheter (SF) or Arctic Front Advance Cryoballoon(CB). Model parameters were estimated using the results of two recently published studies. The ST resulted in average per-patient savings for combined inpatient and outpatient populations of US$1488 and US$4494 compared with SF and CB, respectively. These cost savings were greater in the inpatient setting. The 1-year expected hospital visit costs for PAF ablation were lower with ST than with SF or CB.

Low-fluoroscopy atrial fibrillation ablation with contact force and ultrasound technologies: a learning curve.

BackgroundFluoroscopy exposure during catheter ablation is a health hazard to patients and operators. This study presents the results of implementing a low-fluoroscopy workflow using modern contact force (CF) technologies in paroxysmal atrial fibrillation (PAF) ablation.MethodsA fluoroscopy reduction workflow was implemented and subsequent catheter ablations for PAF were evaluated. After vascular access with ultrasound guidance, a THERMOCOOL SMARTTOUCH® Catheter (ST) was advanced into the right atrium. The decapolar catheter was placed without fluoroscopy. A double-transseptal puncture was performed under intracardiac echocardiography guidance. ST and mapping catheters were advanced into the left atrium. A left atrial map was created, and pulmonary vein (PV) isolation was confirmed via entrance and exit block before and after the administration of isoproterenol or adenosine.ResultsForty-three patients underwent PAF ablation with fluoroscopy reduction workflow (mean age: 66±9 years; 70% male), performed by five operators. Acute success rate (PV isolation) was 96.5% of PVs. One case of pericardial effusion, not requiring intervention, was the only acute complication. Mean procedure time was 217±42 minutes. Mean fluoroscopy time was 2.3±3.0 minutes, with 97.7% of patients having < 10 minutes and 86.0% having < 5 minutes. A significant downward trend over time was observed, suggesting a rapid learning curve for fluoroscopy reduction. Freedom from any atrial arrhythmias without reablation was 80.0% after a mean follow-up of 12±3 months.ConclusionLow fluoroscopy time is achievable with CF technologies after a short learning curve, without compromising patient safety or effectiveness.

A Pilot Study on Parameter Setting of VisiTag™ Module during Pulmonary Vein Isolation.

Objectives To identify optimal predefined criteria (OPC) for filters of the VisiTag™ module in the CARTO 3 system during pulmonary vein isolation (PVI). Methods Thirty patients with atrial fibrillation (AF) who experienced PVI first were enrolled. PVI was accomplished by using a Thermocool SmartTouch catheter. Ablation lesions were tagged automatically as soon as predefined criteria of the VisiTag™ module were met. OPC should be that ablation with the setting resulting in the conduction gap (CG) as few as possible, while contiguous encircling ablation line (CEAL) without the tag gap (TG) on the 3D anatomic model as much as possible. Result(s) When ablation with parameter setting is being catheter movement with a 3 mm distance limit for at least 20 s and force over time (FOT) being off, there were 60 CEAL without TG on the 3D anatomic model. However, 26 CGs were found. After changing FOT setting to be a minimal force of 5 g with 50% stability time, 22 TGs were displayed. Of them, 20 TGs were accompanied by CGs. On reablation at sites of TG with changed parameter setting, 18 CGs were eliminated when 20 TGs disappeared. When reablation with FOT is being a minimal force of 10 g with 50% stability time, 6 remaining CGs were eliminated. However, there was no CEAL. With a mean of follow-up 10.93 months, 2 patients with persistent AF suffered AF recurrence. Conclusion A 3 mm distance limit for at least 20 s and FOT being a minimal force of 5 g with 50% stability time might be OPC for the VisiTag™ module.