P2844Novel temperature guided irrigated ablation catheter: reproducibility of procedural efficiencies and acute success to isolate the pulmonary veins from two multicenter, feasibility studies

2019 ◽  
Vol 40 (Supplement_1) ◽  
Author(s):  
H Puererfellner ◽  
T De Potter ◽  
J Vijgen ◽  
M Grimaldi ◽  
A Natale ◽  
...  

Abstract Background/Introduction The novel catheter with 6 thermocouples for real-time temperature monitoring during irrigated radiofrequency ablation was designed to potentially enhance safety and effectiveness of the Smart Touch Surround Flow (STSF) catheter by incorporating real-time temperature sensing. A supplementary, novel algorithm was developed to modulate power to maintain target temperature during high power/short duration ablation (90W, 4s). Purpose This sub-analysis was performed to examine consistency and reproducibility of the procedural efficiencies and acute success of the novel catheter with optimized temperature control and microelectrodes in treating paroxysmal atrial fibrillation (PAF) across multiple sites from two initial feasibility studies, in standard (QMODE) and high power/short duration (QMODE+) temperature-control ablation modes. Methods The QDOT-MICRO (QMODE, NCT02944968; N=42) and QDOT-FAST (QMODE+, NCT03459196; N=52) studies were both prospective, non-randomized multi-center, clinical investigations completed across 6 and 7 centers, respectively, in Europe. Procedural efficiencies and acute success (PVI via entrance block) was examined across sites within the study. Results In the QDOT-MICRO study, median procedure time (105–155 min), RF ablation time (27.7–39.5 min), and fluoroscopy times (2.2–8 min) during QMODE ablation were similar across the 6 sites. In QMODE+ ablation, median procedure time, RF ablation time, and fluoroscopy times all fall within (84–134 min), (4.8–9.7 min) and (1.1–9.6 min), respectively, across the 7 sites. Fluid delivery by the study catheter was low in both studies: QDOT-MICRO 547±278mL (mean ± SD); QDOT-FAST 382±299. mL (mean ± SD); which is 39.1 and 57.4% lower, respectively, than reported in the SMART SF trial. Esophageal temperature probe was used in the majority of patients (30/42 for QDOT MICRO and 51/52 for QDOT-FAST). Acute PVI was successful in 100% of patients in both studies with no deaths or unanticipated AEs. Conclusion(s) In both feasibility studies, procedural efficiencies were reproducible across study sites in both QMODE and QMODE+, with 100% acute success and good safety outcomes. Efficiencies are likely to improve with further experience. These results need to be confirmed in larger trials. Acknowledgement/Funding Both Studies are Company Sponsored Studies funded by Biosense Webster, Inc.

EP Europace ◽  
2021 ◽  
Vol 23 (Supplement_3) ◽  
Author(s):  
CH Heeger ◽  
MS Sano ◽  
RMS Meyer-Saraei ◽  
CE Eitel ◽  
HL Phan ◽  
...  

Abstract Funding Acknowledgements Type of funding sources: None. Background Catheter ablation for atrial fibrillation (AF) treatment provides effective and durable PVI associated with encouraging clinical outcome. The novel QDot ablation catheter with Qmode + ablation mode (90W/4sec, Figure 1) offers the ability to possibly improve safety and decrease ablation procedure times. Aims We aim to evaluate safety and efficacy of the very high-power short-duration (vHP-SD) temperature-controlled radiofrequency (RF) ablation Qmode + mode for pulmonary vein isolation (PVI) utilizing the novel QDot micro ablation catheter. The data was compared to conventional power-controlled ablation index (AI) guided PVI. Methods Twenty-five consecutive patients with paroxysmal or persistent AF were prospectively enrolled, underwent vHP-SD based PVI (vHP-SD group) and were compared to 25 consecutive patients treated with conventional CF-sensing catheters (control). Results All PVs were successfully isolated utilizing Qmode +. The total median RF ablation time was vHP-SD: 334 (282, 369) sec. vs control: 1567 (1250, 1756) sec. (p < 0.0001), the median procedure time was vHP-SD: 56 (48-62) vs. control: 104 (92-122) min (p < 0.0001). No differences in periprocedural complications were observed. Conclusions The novel Qmode + provides safe and effective PVI with impressive short RF time and short procedures times. Procedure time and RF time were substantial lower in the vHP-SD group. Abstract Figure 1


EP Europace ◽  
2021 ◽  
Vol 23 (Supplement_3) ◽  
Author(s):  
J Schreieck ◽  
D Heinzmann ◽  
C Scheckenbach ◽  
M Gawaz ◽  
M Duckheim

Abstract Funding Acknowledgements Type of funding sources: None. Introduction Local impedance (LI) drop can predict sufficient lesion formation during radiofrequency ablation (RF). Recently, a novel ablation catheter technology able to measure LI and contact force has been made available for clinical use. High power short duration (HPSD) RF ablation has been shown to be feasible for atrial fibrillation (AF) ablation with short procedure time. We used LI drop and plateau formation to guide duration of 50 Watt RF power applications for circumferential pulmonary vein isolation (PVI). Methods Consecutive patients with indication for de novo AF ablation (n = 32, age 65 ± 10 years) with paroxysmal (n = 16) or persistent (n = 16) AF underwent ultra high density 3D mapping of the left atrium and catheter ablation. Thereafter, ipsilateral PV encircling with 50 Watt RF-applications targeting an interlesion distance of ≤ 6mm and a contact force of 10-30g was performed. Duration of HPSD RF application between 7-15s was guided by impedance drop >20 Ohm and plateau formation of LI. Further ablation strategy was left to the investigator’s discretion. Esophageal temperature measurement was performed using a three thermistor catheter with temperature cut off 39.0°C. In case of temperature rise or very near esophageal contact to the circumferential line, RF application time was shortened to 7s. Patients underwent adenosine testing after PVI. Previously we performed all types of AF ablation using an LI guided HPSD ablation without contact force measurement capability in 80 patients. Results Complete PVI was achieved in all pts with only 13.5 ± 4.3 min cumulative RF application duration and an ablation procedure duration of 46.5 ± 10.4 min with the novel LI measuring catheter. First-pass isolation of ipsilateral veins was achieved in 75% of circles. Recurrence of PV conduction during waiting period (20min) and adenosine testing occured in 25% of circles, and was reablated in most patients with a single spot of HPSD application. Using 94 ± 36 RF application per patient, mean maximum LI drop was 23.6 ± 4.0 Ohm. Reconnected fibers were associated with low LI drop due to instability of contact in most cases due to breathing in case of difficult sedation of the patients. No serious complications occurred in all 32 pts using HPSD with the novel contact force catheter design. Conclusion Guiding of HPSD RF ablation by LI is highly efficient and safe. A novel local impedance algorithm in combination with contact force sensing enable short PVI times with low early recurrence of PV conduction. Prediction of permanent lesions seems possible and the only limitation seems to be unstable RF catheter contact due patients breathing. Follow up have to be waited.


2019 ◽  
Vol 40 (Supplement_1) ◽  
Author(s):  
E Kulstad ◽  
M Mercado-Montoya ◽  
S Shah

Abstract Introduction Recent clinical data show that high-power, short-duration (HPSD) radiofrequency (RF) ablation can result in a similar esophageal injury rate as traditional low-power, long-duration (LPLD) ablation. Existing methods to prevent esophageal injury have yielded mixed results and can result in prolonged procedure time, potentially increasing the incidence of post-operative cognitive dysfunction. A new esophageal cooling device currently available for whole-body temperature modulation is being studied for the prevention of esophageal injury during LPLD RF ablation and cryoablation. We sought to develop a mathematical model of HPSD ablation in order to quantify the capability of this new esophageal cooling device to protect from esophageal injury under high-power conditions. Methods Using a model we developed of HPSD RF ablation in the left atrium, we measured the change in esophageal lesion formation and the depth of lesions (measured as percent transmurality) with the esophageal cooling device in place and operating at a temperature from 5°C to 37°C. Tissue parameters, including thermal conductivity, were set to average values obtained from existing literature, and energy settings were evaluated at 50W for between 5 and 10 seconds, and at 90W for a duration of 4 seconds. Results Esophageal injury as measured by percent transmurality was considerably higher at 50W and 10s duration than at 90W of power with 4s duration, although both settings showed potential for esophageal injury. The protective effect of the esophageal cooling device was evident for both cases, with a greater effect when using 50W for 10s (Figure 1). At the coldest device settings, using a 5 min pre-cooling period also reduced the transmurality of the intended atrial lesions. Esophageal protection in HPSD ablation Conclusions Esophageal cooling with a new patient temperature management device shows protective effects against thermal injury during RF ablation across a range of tissue thermal conductivity, using a variety of high-power settings, including 90W applied for 4 seconds. Adjusting the cooling power by adjusting the circulating water temperature in the device allows for a tailoring of the protective effects to operating conditions. Acknowledgement/Funding Attune Medical


2021 ◽  
Author(s):  
Kaihao Gu ◽  
Shengjie Yan ◽  
Xiaomei Wu

Abstract Background: High power-short duration ablation is an emerging conception for cardiac RF treatment. But the biophysical ablation properties of this technique have not been fully explored. This study compared the electric field characteristics and thermal lesion dimension in High power-short duration (HP-SD) radio frequency (RF) ablation and standard RF ablation by using the finite element method. Results: The results demonstrated that the lesion size and temperature in HP–SD RF ablation increased faster than standard RF ablation. The thermal lesion volume in both ablation modes demonstrated a linear increase and the rate of increase of HP–SD RF ablation grew faster than that of standard RF ablation. For HP–SD application at 50 W for 5 s, the lesion depth was shallower (1.74 to 2.1 mm vs 2.40 to 3.15 mm) and the surface lesion diameter was broader (2.76 to 3.32 mm vs 2.42 to 2.66 mm) than that for standard RF ablation at 25 W for 30 s. Conclusion: Compared with standard RF ablation, HP–SD RF ablation creates a broader lesion width and surface lesion diameter but shallower lesion depth, with a faster increase in temperature. HP–SD ablation is more able to achieve uniform and contiguous lesion shape, which is a suitable for point-to-point RF ablation procedures.Higher temperature was formed in deeper space of cardiac tissue in HP–SD ablation. The duration of HP–SD ablation should be strictly controlled for preventing the steam occur in tissue.


2020 ◽  
Vol 31 (6) ◽  
pp. 1332-1339 ◽  
Author(s):  
Felix Bourier ◽  
Konstantinos Vlachos ◽  
Antonio Frontera ◽  
Claire A. Martin ◽  
Anna Lam ◽  
...  

EP Europace ◽  
2020 ◽  
Vol 22 (Supplement_1) ◽  
Author(s):  
G Caluori ◽  
E Odehnalova ◽  
J Krenek ◽  
T Jadczyk ◽  
M Pesl ◽  
...  

Abstract Funding Acknowledgements MEYS- CR (ref#LQ1605 and LM2015062) Background/Introduction High-power short-duration (HPSD) radiofrequency (RF) ablation relies on the application of intense thermal fields for a carefully restricted time, in order to quickly obtain deep but precise lesions that spare the structures surrounding the heart. The approach is still under evaluation across different therapies and catheter technologies. To the present day there is no available characterization of HPSD ablation supported by remote magnetic navigation (RMN). Purpose To describe the safety issues regarding HPSD ablation in atria and ventricles with RMN systems, while characterizing the thermal lesion size and continuity in an acute closed-chest swine model. Methods The animal trial was divided in two arms (left ventricular and atrial). 10 female large white pigs (6-month-old weight 55-65 kg) were employed in each arm. Endocardial electroanatomical mapping and ablation were performed with RMN assistance to provide stable contact and flexible maneuvering. The ventricular cohort was divided in 5 power settings (30-40-50-60-70W). Multiple RF applications (10 ca./animal) were delivered until a pop occurred or up to 60s. In the atrial cohort the animals were divided by a combination of power/application time (50W/20s – 70W/10s – 90W/4s). Intracaval right atrial ablation lines and postero-lateral left atrial lines were performed in a point-by-point fashion (ca. 4mm distance). Irrigation rate was 30ml/min. The ventricular lesions were measured via software after 9.4T MRI of fixed hearts. The atrial lesions were measures during pathological examination after explanation. Results In the ventricular arm, we obtained a safety calibration curve linking the imposed power setting to the maximal time of application. The time before a pop decreased non-linearly from 60s down to 17.69 ± 8.21 s at 70W. No statistically significant differences were observed when comparing lesions depth, width and volume among the selected power settings. In the atrial arm we observed on the post-ablation maps a significant decrease of intracaval lesions (i.e. area with bipolar voltage <1.5mV) width (17.57 ± 1.89 mm for 50W/4s down to 10.16 ± 1.56 mm for 90W/4s). Pericardial, pleural and aortic damages were visible across all the employed settings, with less pronounced alterations for 90W/4s. Transmural lesions were visible both on the right and left atrium, with evident gaps for 50W/20s. Conclusion The presented work assesses for the first time the safety limits of HPSD ablation on healthy ventricular myocardium. We provide a calibration curve for faster RF ablation with comparable lesion features. Furthermore, we expanded the previously reported application in the atrium adding the benefits of stable controlled contact provided by RMN systems. We highlighted the benefits (e.g. faster, continuous and localized lesion formation) and risks for peripheral structures using HPSD ablation for supraventricular tachycardia interventions. Abstract Figure.


Author(s):  
Chengming Ma ◽  
Xiaomeng Yin ◽  
Yunlong Xia ◽  
Jiao Sun ◽  
Shiyu Dai ◽  
...  

Abstract Purpose Coronary sinus-related arrhythmias are common; however, it is difficult to perform radiofrequency (RF) ablation at these sites efficiently and safely. High-power, short-duration ablation (HPSD) is a proven alternative strategy for pulmonary vein isolation (PVI); whether it can be applied to ablation of the coronary sinus is unknown. The purpose of this preliminary study was to evaluate the feasibility and safety of HPSD ablation in the coronary sinus. Methods Firstly, we demonstrated 4 clinical cases of 3 types of arrhythmias who had unsuccessful ablation with standard power initially, but received successful ablations with HPSD. Secondly, RF ablation was performed in the coronary sinus ostium (CSO) and middle cardiac vein (MCV) of 4 in vitro swine hearts. Two protocols were compared: HPSD (45 W/5 S×5 rounds) and a conventional strategy that used low-power, long-duration ablation (LPLD: 25 W/10 S ×5 rounds). The total duration of HPSD protocol was 25 s, and which of LPLD was 50 s. Results A total of 28 lesions were created. HPSD can produce longer, wider, deeper, and larger lesions than LPLD. This difference was more pronounced when the ablation was in the MCV. One instance of steam pop occurred during LPLD in the MCV. Conclusions HPSD is an effective alternative strategy for ablation in coronary sinus according to clinical applications and preliminary animal study. However, the safety needs to be further evaluated based on more animal and clinical studies.


EP Europace ◽  
2021 ◽  
Vol 23 (Supplement_3) ◽  
Author(s):  
M Brunelli ◽  
M Schwaar ◽  
C Isensee ◽  
S Goth ◽  
H Schmidt ◽  
...  

Abstract Funding Acknowledgements Type of funding sources: None. Background high power short duration (HPSD) ablation is at least as safe while reducing procedure time than radiofrequency (RF) ablation with lower power in pts undergoing pulmonary vein isolation (PVI) for paroxysmal atrial fibrillation (AF). Purpose: to compare safety and efficacy of 2 different: 1) RF energy set up (FlexAbility: 70W, 41°, 6-10s, 11ml/h vs. TactiCath: 50W, 41°, LSI 5-6, 17ml/h, both Abbott), and 2) ablation strategies (posterior wall isolation (PWI) in addition to PVI vs. PVI) in pts undergoing their first ablation for paroxysmal AF. Methods: since June 2020 pts are prospectively assigned to alternatively undergo their RF catheter ablation with the FlexAbility (v-HPSD) or the TactiCath (LSI-HPSD) catheters (aim 200 pts). In addition, pts were alternatively assigned to PVI + PWI vs. PVI. All procedures were done using a 3D-mapping system (Ensite Precision), the ablation catheter was stabilized with a long sheath (Agilis) and a continuous series of lesions (4mm) were plotted around the PV, at the roof and between the 2 inferior PVs. On the PW, RF lesions were limited to 6s and 5 LSI for the v-HPSD and LSI-HPSD groups. Endoscopy was performed shortly after ablation in all pts and thermal esophageal lesion (TEL) characterized with the Kansas classification. Results: since June 2020 56 pts [61 ± 13 years old, 17 (30%) female, CHA2DS2-Vasc 2.3 ± 1.5, 55 ± 77 left ventricular ejection fraction] underwent v-HPSD (#28) and LSI-HPSD (#28) ablation. In 2/14 (14%) and in 3/15 (20%) pts (v-HPSD and LSI-HPSD groups, respectively) initially assigned to undergo simple PVI, PWI was added due to PW dependent flutter or evidence of pro-arrhythmic slow conduction on the PW. A shorter RF time to achieve PVI (17 ± 3 vs. 25 ± 6 min; P<.0001) was found for the v-HPSD group, although acute reconnection were numerically higher (9 vs. 4) and procedural time did not differ (32 ± 8 vs. 35 ± 9 min). Whenever attempted, PWI (#16 for each v-HPSD and LSI-HPSD group) was always successful. When v-HPSD and LSI-HPSD group were compared, no differences were found in RF and procedure time both at the roof (2.3 ± 0.9 vs. 2.7 ± 1.1 min and 3 ± 1.4 vs. 3.4 ± 1 min, respectively) and between the 2 inferior PVs (2.6 ± 0.6 vs. 2.9 ± 0.7 min and 4.3 ± 1.9 vs. 3.8 ± 1.2 min, respectively). Total RF (19.7 ± 4.5 vs. 28.5 ± 6.6 min, P<.0001) was shorted in the v-HPSD, but X-Ray (1.4 ± 0.7 vs. 1.2 ± 0.8 min) and total procedural time (102 ± 17 vs. 110 ± 20 min) did not differ. Rate of TELs was not different and found in 18% (#5: 4 I, 1 IIA) and 14% (all IIA) pts assigned to v-HPSD and LSI-HPSD respectively. A numerically higher number of TELs (6 vs. 3) was seen when PWI was pursued, although this did not prolong total RF and procedure time. Conclusion: a shorter RF time is associated with v-HPSD vs. LSI-HPSD strategy, although procedural time did not differ. TELs are a relative rare finding, and only numerically higher when isolation of the PW is pursued in addition to PV isolation.


Author(s):  
Roland Tilz ◽  
Makoto Sano ◽  
Julia Vogler ◽  
Thomas Fink ◽  
Roza Meyer-Saraei ◽  
...  

Background: Catheter ablation for atrial fibrillation (AF) treatment provides effective and durable pulmonary vein isolation (PVI) and is associated with encouraging clinical outcome. A novel CF sensing temperature-controlled radiofrequency (RF) ablation catheter allows for very high-power short-duration (vHP-SD, 90W/4 seconds) ablation aiming a potentially safer, more effective and faster ablation. We thought to evaluate preliminary safety and efficacy of vHP-SD ablation for PVI utilizing a novel vHP-SD catheter. The data was compared to conventional power-controlled ablation index (AI) guided PVI utilizing conventional contact force (CF) sensing catheters. Methods and Results: Fifty-six patients with paroxysmal or persistent AF were prospectively enrolled in this study. Twenty-eight consecutive patients underwent vHP-SD based PVI (vHP-SD group) and were compared to 28 consecutive patients treated with conventional CF-sensing catheters utilizing the AI (control group). All PVs were successfully isolated using vHP-SD. The median RF ablation time for vHP-SD was 338 (IQR 286, 367) seconds vs control 1580 (IQR 1350, 1848) seconds (p<0.0001), the median procedure duration was vHP-SD 55 (IQR 48-60) minutes vs. control 105 (IQR 92-120) minutes (p<0.0001). No differences in periprocedural complications were observed. Conclusions: This preliminary data of the novel vHP-SD ablation mode provides safe and effective PVI. Procedure duration and RF ablation time were substantially shorter in the vHP-SD group in comparison to the control group.


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