Pulmonary vein isolation using new technologies to improve ablation lesion formation: Initial results comparing enhanced catheter tip irrigation (Surround Flow(®)) with contact force measurement (Smarttouch(®)).
ABSTRACT: Pulmonary vein reconnection after pulmonary vein isolation (PVI) is a significant problem in the treatment of paroxysmal atrial fibrillation (AF). We report about patients who underwent contact force (CF) guided PVI using CF catheter and compared them to patients with PVI using an ablation catheter with enhanced tip irrigation.A total of 59 patients were included in the analysis. In 30 patients circumferential PVI was performed using the Thermocool Smarttouch(®) ablation catheter (ST) whereas in 29 patients circumferential PVI using the Thermocool Surround Flow SF(®) ablation catheter (SF) was performed. Patients were compared in regard to procedure time, fluoroscopy time/dose as well as RF-application duration and completeness of PVI. Adverse events (pericardial effusion, PV stenosis, stroke, death) were evaluated. The presence of sinus rhythm off antiarrhythmic medication was assessed during 6 months follow-up using multiple 7 day Holter-ECGs.In both groups, all PVs were isolated without serious adverse events. Procedure time was 2.15 ± 0.5 h (ST) vs. 2.37 ± 1.13 h (SF) (p = 0.19). Duration of RF-applications was 46.6 ± 18 min (ST) and 49.8 ± 19 min (SF) (p = 0.52). Fluoroscopy time was 25.2 ± 13 min (ST) vs. 29 ± 18 min (SF), fluoroscopy dose 2675.6 ± 1658 versus 3038.3 ± 1997 cGym(2) (p = 0.36 and 0.46 respectively). Sinus rhythm off antiarrhythmic medication validated with 7 day Holter ECGs was present in both groups in 72% of patients after 6 months of follow up.PVI using the new contact force catheter is safe and effective in patients with paroxysmal AF.
Project description:OBJECTIVES:The 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 percutaneous ablation of paroxysmal or persistent atrial fibrillation (AF), compared with other ablation catheters, or with the ST with the operator blinded to CF data. DESIGN:Systematic literature review and meta-analysis. BACKGROUND:Emerging evidence suggests improved clinical outcomes of AF ablation using CF-sensing catheters; however, reviews to date have included data from multiple, distinct CF technologies. METHODS:We conducted a systematic review and meta-analysis of published studies comparing the use of ST versus other ablation catheters for the treatment of AF. A comprehensive search of electronic and manual sources was conducted. The primary endpoint was freedom from recurrent atrial tachyarrhythmia (AT) at 12 months. Procedural and safety data were also analysed. RESULTS:Thirty-four studies enrolling 5004 patients were eligible. The use of ST was associated with increased odds of freedom from AT at 12 months (71.0%vs60.8%; OR 1.454, 95% CI 1.12 to 1.88, p=0.004) over the comparator group, and the effect size was most evident in paroxysmal AF patients (75.6%vs64.7%; OR 1.560, 95% CI 1.09 to 2.24, p=0.015). Procedure and fluoroscopy times were shorter with ST (p=0.05 and p<0.01, respectively, vs comparator groups). The reduction in procedure time is estimated at 15.5 min (9.0%), and fluoroscopy time 4.8 min (18.7%). Complication rates, including cardiac tamponade, did not differ between groups. CONCLUSIONS:Compared with the use of other catheters, AF ablation using the CF-sensing ST catheter for AF is associated with improved success rates, shorter procedure and fluoroscopy times and similar safety profile.
Project description:<h4>Introduction</h4>Radiofrequency (RF) atrial fibrillation (AF) ablation using a catheter dragging technique may shorten procedural duration and improve durability of pulmonary vein isolation (PVI) by creating uninterrupted linear ablation lesions. We compared a novel AF ablation approach guided by Grid annotation allowing for "drag lesions" with a standard point-by-point ablation approach in a single-center randomized study.<h4>Methods</h4>Eighty-eight paroxysmal or persistent AF patients were randomized 1:1 to undergo RF-PVI with either a catheter dragging ablation technique guided by Grid annotation or point-by-point ablation guided by Ablation Index (AI) annotation. In the Grid annotation arm, ablation was visualized using 1 mm³ grid points coloring red after meeting predefined stability and contact force criteria. In the AI annotation arm, ablation lesions were created in a point-by-point fashion with AI target values set at 380 and 500 for posterior/inferior and anterior/roof segments, respectively. Patients were followed up for 12 months after PVI using ECGs, 24-h Holter monitoring and a mobile-based one-lead ECG device.<h4>Results</h4>Procedure time was not different between the two randomization arms (Grid annotation 71 ± 19 min, AI annotation 72 ± 26 min, p = .765). RF time was significantly longer in the Grid annotation arm compared with the AI annotation arm (49 ± 8 min vs. 37 ± 8 min, respectively, p < .001). Atrial tachyarrhythmia recurrence was documented in 10 patients (23%) in the Grid annotation arm compared with 19 patients (42%) in the AI annotation arm with time to recurrence not reaching statistical significance (p = .074).<h4>Conclusions</h4>This study shows that a Grid annotation-guided dragging approach provides an alternative to point-by-point RF-PVI using AI annotation.
Project description:<h4>Introduction</h4>Both radiofrequency (RF) and cryoballoon (CB) ablation are treatment options for persistent atrial fibrillation (PsAF). An important recent innovation in RF ablation is Ablation Index (AI), known also as the VISITAG SURPOINT™ Module, a composite lesion quality marker whose use has been shown to significantly reduce the incidence of acute and late pulmonary vein (PV) reconnection and the recurrence of atrial arrhythmias in PsAF. Due to a lack of direct comparative evidence between the latest generations of technologies, there is uncertainty regarding the best treatment option in PsAF. The objective of the present study was to conduct a matching-adjusted indirect treatment comparison (MAIC) using individual patient-level data (IPD) to assess the comparative effectiveness of the THERMOCOOL SMARTTOUCH™ Catheter or the THERMOCOOL SMARTTOUCH™ SF Catheter with AI/VISITAG SURPOINT™ Module (STAI) versus the second-generation CB catheter (Arctic Front Advance™; herein referred to as CB) with respect to 12-month atrial arrhythmia recurrence, fluoroscopy time, and procedural efficiency.<h4>Methods</h4>IPD for STAI were obtained from four investigator-initiated studies and were pooled. Comparable CB studies identified from a systematic literature review were also pooled. In the absence of a common treatment arm between STAI and CB studies, an unanchored MAIC was conducted. The primary analysis compared the pooled STAI IPD to the pooled CB cohort, with corrections for differences across trials, including eligibility criteria and patient baseline characteristics. Scenario and sensitivity analyses were conducted to assess the robustness of the primary analysis.<h4>Results</h4>In the primary analysis, which was adjusted for left atrial diameter (LAD), age, diabetes, and sex, STAI was associated with a statistically significant 65% relative reduction in the rate of arrhythmia recurrence compared to CB at 12-month follow-up (HR 0.35; 95% CI 0.23, 0.52). STAI was associated with shorter total fluoroscopy time than CB but longer procedure time. Results were consistent across scenario and sensitivity analyses.<h4>Conclusion</h4>Radiofrequency ablation with AI significantly reduced atrial arrhythmia recurrence at 12-month follow-up and fluoroscopy time compared to CB, with longer procedure times.
Project description:Background:Atrial flow regulator (AFR) (Occlutech, Helsingborg, Sweden) are self-expanding, circular devices. A flexible waist in the centre connects the two discs and has a centrally located shunt. Case summary:We report a case of an 80-year-old woman undergoing a repeat left atrial ablation for persistent atrial fibrillation with an implanted AFR. The AFR was implanted 1 year prior to the procedure for heart failure with preserved ejection fraction as part of the AFR-PRELIEVE trial. A single, fluoroscopy-guided, transseptal puncture was performed infero-posterior to the device, allowing the positioning of the mapping (LASSO® 20?mm, Biosense Webster, Irvine, CA, USA) and ablation (Thermocool Smarttouch SF, CARTO®, Biosense Webster, Irvine, CA, USA) catheter in the left atrium. Three-dimensional mapping (CARTO®, Biosense Webster, Irvine, CA, USA) and left atrial ablation were successfully performed. After the procedure, fluoroscopy and transthoracic echocardiography showed an unchanged device position. Discussion:To our knowledge, this is the first case report of a transseptal puncture in a patient with an implanted AFR. Transseptal puncture in patients with an implanted AFR seems to be safe and feasible. With device diameters of 21-23 mm and based on previous studies on similar devices, transseptal puncture should be possible in most patients, as opposed to puncture through the device.
Project description:Observation of the time-to-pulmonary vein isolation (TTI) by a spiral mapping catheter has emerged as a valuable procedural parameter in cryoballoon pulmonary vein isolation (PVI). The 1st generation spiral mapping catheter (Achieve, SMC1) has been available as an 8-polar catheter with a distal loop diameter of 15 or 20 mm. The novel spiral mapping catheter (Achieve Advance, SMC2) was designed as a true guidewire and is available, in addition to the sizes of the SMC1, as a 10-polar mapping catheter with a distal loop diameter of 25 mm. Whether these novel features of SMC2 influence procedural characteristics of Cryo-PVI in comparison to SMC1 has not been reported. In this prospective cohort study 158 patients (age 65.1?±?12.4 years, female 39%, paroxysmal AF 60%) undergoing PVI with the 2nd generation cryoballoon were included. SMC1 was used in 57 patients (36%), whereas 101 patients (64%) underwent Cryo-PVI with the SMC2. All PVs (623/623, 100%) were isolated successfully. Mean procedure duration was 72.0?±?18.9 min in the SMC1 group and 74.4?±?19.1 min in the SMC2 group (p?=?0.432). Mean fluoroscopy time was also not different between both study groups (SMC1 15.7?±?6.6 min, SMC2 15.7?±?7.3 min, p?=?0.593). TTI was observed in 68.6% of pulmonary veins in the SMC1 group, whereas TTI observation rate was 82.6% in the SMC2 group (p?<?0.001). Number of freezes (5.5?±?1.5 vs. 6.5?±?1.9; p?=?0.001) and total freeze duration (14.1?±?4.5 vs. 17.6?±?5.6; p?<?0.001) were increased in the SMC2 group. SMC2 significantly increases TTI observation rate during Cryo-PVI. Procedure duration and fluoroscopy time are similar and number of freezes and total freeze duration are increased compared to PVI with SMC1 due to decreased stability and maneuverability of SMC2.
Project description:<h4>Introduction</h4>The advent of electroanatomical mapping (EAM) systems for pulmonary vein isolation (PVI) has dramatically decreased radiation exposure. However, the need for some fluoroscopy remains for obtaining left atrial (LA) access. The aim was to test the feasibility of fluoroscopy-free PVI in patients with atrial fibrillation (AF) and a patent foramen ovale (PFO) guided solely by an EAM system.<h4>Methods</h4>Consecutive patients with AF undergoing PVI and documented PFO were studied. An EAM-guided approach without fluoroscopy and ultrasound was used. After completing the map of the right atrium, the superior vena cava and the coronary sinus, a catheter pull-down to the PFO was performed allowing LA access. The map of the LA and subsequent PVI was also performed without fluoroscopy.<h4>Results</h4>30 patients [age 61±12 years, 73% male, ejection fraction 0.64 (0.53-0.65), LA size in parasternal long axis 38±7 mm] undergoing PVI were included. The time required for right atrial mapping including transseptal crossing was 9±4 minutes. Total procedure time was 127±37 minutes. Fluoroscopy-free PVI was feasible in 26/30 (87%) patients. In four patients, fluoroscopy was needed to access (n = 3) or to re-access (n = 1) the LA. In these four patients, total fluoroscopy time was 5±3 min and the DAP was 14.9±13.4 Gy*cm2. Single-procedure success rate was 80% (24/30) after a median follow-up of 12 months.<h4>Conclusion</h4>In patients with a documented PFO, completely fluoroscopy-free PVI is feasible in the vast majority of cases.
Project description:<h4>Background</h4>New protocols of pulmonary veins isolation (PVI) result in easier and more efficient procedure performance. Ablation index (AI) is the novel tool which helps to achieve transmural lesions during catheter ablation. However, benefit of this protocol in the reduction of myocardial injury is still not known.<h4>Purpose</h4>The aim of the study was to compare myocardial injury during catheter ablation using standard and AI protocol.<h4>Methods</h4>To the analysis we included 24 patients with paroxysmal atrial fibrillation, who underwent radiofrequency catheter PVI using CARTO system (Biosense Webster, Inc). In all patients cardiac troponin I (cTnI) levels were assessed before and 24 hours after the procedure. In 12 patients PVI was performed using continuous applications (dragging technique) and in 12 patients during PVI ablation AI protocol was implemented. To unify analyzed groups, we excluded patients with additional ablation lines (including line separating ipsilateral pulmonary veins).<h4>Results</h4>In analyzed group mean age was 59.3 ± 7.7 years and 18 (75%) patients were male. There were no differences in the clinical characteristic between both subgroups. Trend in shorter total x-ray time was observed in AI group compared with dragging group (8.6 ± 5.4 vs. 5.3 ± 3.2 min.; <i>P</i> = .093) with no differences in total procedure time (146.3 ± 28.9 vs. 153.2 ± 37.1 min.; <i>P</i> = .616). Twenty-four hours after the PVI procedure cTnI levels were significantly lower in AI group than in dragging group (1.984 ± 0.644 vs. 3.369 ± 1.818 ng/mL; <i>P</i> = .026), with no difference in mean baseline cTnI levels (0.004 ± 0.006 vs. 0.015 ± 0.032 ng/mL; <i>P</i> = .304).<h4>Conclusion</h4>Presented study revealed that compared with standard, continuous applications, AI protocol implementation results in reduction of myocardial injury during catheter PVI in patients with paroxysmal atrial fibrillation.
Project description:<h4>Background</h4>Cryoballoon ablation was established as an effective and safe modality to achieve pulmonary vein isolation (PVI) in paroxysmal atrial fibrillation (PAF). However, its role in persistent atrial fibrillation (PersAF) remains unclear.<h4>Objective</h4>This study aimed to evaluate the efficacy and safety of cryoballoon PVI in PAF and PersAF comparing conventional radiofrequency catheter ablation (RFCA).<h4>Methods</h4>Two hundred patients undergoing cryoballoon ablation for symptomatic AF were consecutively enrolled in this retrospective study. For comparison, 210 patients undergoing RFCA in the same period were included. The primary outcome was a recurrence of any atrial tachyarrhythmias (ATas) after the index ablation. 12-lead ECG and 24-hour Holter monitoring were obtained at 1,3,6 and 9-12 months.<h4>Results</h4>PVI by cryoablation alone was achieved in 197 patients (98.5%). ATas-free survival at 12 months post-ablation was 72.7% in the cryoablation and 80.6% in the RFCA group (P = 0.123), respectively. The cryoablation showed comparable efficacy maintaining sinus rhythm compared with RFCA in PAF (P = 0.539), whereas in PersAF, ATas-free survival was significantly lower in cryoablation (P = 0.039). PV reconnection was observed in the majority of patients (14/16, 87.5%) who receive redo RFCA. Complications were encountered in 10 patients, including femoral arteriovenous fistula (n = 1), transient phrenic nerve palsy (n = 8), and minimal amount pericardial effusion (n = 1).<h4>Conclusion</h4>The efficacy of cryoballoon PVI is comparable with conventional RFCA in PAF, whereas PVI alone using cryoballoon may not be insufficient to maintaining sinus rhythm in PersAF. The safety of cryoballlon PVI is tolerable.
Project description:<h4>Background</h4>A new zero-fluoroscopy technique for electrophysiology catheter navigation relying on intracardiac echocardiography (ICE) has been recently reported (Ice&ICE trial). We investigated potential differences in efficacy, safety or procedural performance between conventional fluoroscopy- and ICE-guided cryothermal ablation (CA) in symptomatic AVNRT patients.<h4>Methods</h4>Clinical and electrophysiological data of AVNRT patients included in the Ice&ICE trial (22 patients, 16 females; =zero-fluoroscopy group) were compared to those of consecutive AVNRT patients, who underwent fluoroscopy-guided CA (25 patients, 17 females; = fluoroscopy group) during the last 2 years in our institution.<h4>Results</h4>Slow pathway ablation or modulation was successful in all patients. Fluoroscopy time and radiation dose in the fluoroscopy group were 11.2?±?9.0?min and 20.3?±?16.2Gycm<sup>2</sup>, whereas no fluoroscopy was used in the opposite group (p <? 0.001, respectively). EPS duration was not different between the groups (zero-fluoroscopy:101.6?±?40.2?min, fluoroscopy:99.4?±?37.2?min, p =?n.s.). Catheter placement time was significantly shorter in the fluoroscopy group (2.2?±?1.6?min vs. 12.0?±?7.5?min, p <? 0.05), whereas cryo-application duration (from the first cryo-mapping to the last CA) was significantly shorter in the zero-fluoroscopy group (27.5?±?37.0?min vs. 38.1?±?33.9?min, p <? 0.05). Mean cryo-mapping and CA applications were numerically lower in the zero-fluoroscopy group (CM:7.5?±?5.7 vs. 8.8?±?6.2; CA:3.1?±?1.7 vs. 3.2?±?2.0, p =?n.s.). No major adverse events occurred in both groups. After 15.0?±?4.2?months, arrhythmia recurrence was not different between the groups (4.5% vs. 8.0%, p =?n.s.).<h4>Conclusions</h4>Zero-fluoroscopy ICE-guided EP catheter navigation shows comparable efficacy and safety to fluoroscopic guidance during CA in AVNRT patients. ICE visualization of catheters and endocardial structures within the triangle of Koch shortens the cryo-application duration, though time needed for catheter placement is longer, when compared with conventional fluoroscopic guidance, which results in similar mean EPS duration with both navigation techniques.<h4>Trial registration</h4>(German Clinical Trials Register ID: DRKS00011360 ; Registration Date 14.12.2016).
Project description:<h4>Introduction</h4>In May 2020, a novel cryoballoon system (POLARx; Boston Scientific) became available for catheter ablation of atrial fibrillation (AF). The design of the cryoballoon is comparable to the Arctic Front Advance Pro (AFA-Pro; Medtronic), but it is more compliant during freezing. We compared the procedural efficacy, biophysical parameters, and risk of phrenic nerve palsy (PNP) between the two cryoballoons.<h4>Methods</h4>Embase, MEDLINE, Web of Science, Cochrane, and Google Scholar databases were searched until June 1, 2021 for relevant studies comparing POLARx versus AFA-Pro in patients undergoing pulmonary vein isolation (PVI) for AF.<h4>Results</h4>A total of four studies, involving 310 patients were included. There was no difference between the two groups for outcomes regarding procedural efficacy: acute PVI (odds ratio [OR]: 0.43; 95% confidence interval [CI]: 0.06 to 3.03; p = .40), procedure time (mean difference [MD]: 8.15 min; 95% CI: -8.09 to 24.39; p = .33), fluoroscopy time (MD: 1.32 min; 95% CI: -1.61 to 4.25; p = .38) and ablation time (MD: 1.00 min; 95% CI: -0.20 to 2.20; p = .10). The balloon nadir temperature was lower for all individual pulmonary veins (PV) in POLARx compared with AFA-Pro (MD: -9.74°C, -9.98°C, -6.72°C, -7.76°C, for left superior PV, left inferior PV, right superior PV, and right inferior PV, respectively; all p < .001). The incidence of PNP was similar between groups (OR: 0.79; 95% CI: 0.22 to 2.85; p = .72).<h4>Conclusion</h4>In AF patients undergoing PVI, POLARx and AFA-Pro had a similar procedural efficacy. Balloon nadir temperatures were lower with POLARx, however, the incidence of PNP was similar.