Distal Electrode Research Articles

PO-710-01 “ELECTRODE TISSUE COUPLING” IS A NEW MAIN DETERMINANT OF RF LESION CREATION - EXPERIENCE FROM A CARDIAC ANIMAL MODEL

Radiofrequency (RF) current is a classic ablation technology used in the EP lab. By now it is assumed that RF lesion seize is mainly determined by RF power, duration and contact force. This ex vivo animal model study shows that a new parameter - “electrode tissue coupling” (ETC) - plays an additional major role in RF lesion creation. The ETC level describes the amount of electric contact between the RF electrode and cardiac tissue: In minor ETC levels, only the distal electrode connects to tissue. In full ETC levels, the whole RF electrode is embedded in cardiac tissue. The aim of this study was to investigate the influence of ETC levels on RF-lesion size. RF-lesions were created using an ex vivo porcine cardiac model. The experimental setup consisted of a saline-filled container, a dispersive electrode, a heated thermostat and a circulation pump to imitate in vivo conditions. Global impedance was kept at 120 Ohm as well as the temperature at 37°C. RF-lesions were created using identic values of RF duration and contact force. A RF power of 20W, 30W, 40W, and 50W was used. The ETC levels were varied between minor and full coupling. All parameters (power, temperature, global and local impedance, contact force, lesion size) were measured during application of RF-current, enabling real-time correlation of RF parameters and lesion size. In total, 1923 measurements during application of RF-current were analyzed. In ETC III (full tissue coupling), lesions became significantly wider and deeper. In 20W ablations, lesion diameters were significantly (1.68 fold) larger when applying ETC III instead of ETC I. This relation was found in variations of RF parameters. Baseline local impedance and local impedance drop showed a high correlation with selected ETC levels. The average baseline local impedance in ETC I was 207.2 Ohm, compared to 267.3 Ohm in ETC III (p < 0.01). In addition to by now known parameters (power, duration, contact force), ETC is a main determinant of lesion size. Higher ETC levels result in higher amounts of RF current going into adjacent tissue instead of current dissipation into the blood pool. In clinical practice, the ETC level can be predicted by baseline local and global impedance. Observation of these parameters should become clinical practice during RF ablation.

Comparison of two catheters measuring local impedance: local impedance variation vs lesion characteristics and steam pops.

The size of the distal electrode and the method of measuring local impedance (LI) are different between the IntellaNav MiFi-OI™ (MiFi-OI) and IntellaNav STABLE POINT™ (SP) catheters. We investigated the impact of these differences on LI, efficacy, and safety of radiofrequency (RF) applications. RF applications at a range of powers (30W, 40W, and 50W), contact forces (10g and 20g), and durations (10-120s) were performed in excised porcine hearts (N = 48). LI variation was defined by δLI-drop (= initial LI - post-RF LI) and %LI-drop (= δLI-drop/initial LI) × 100, and the relationship between lesion characteristics and LI variation was compared. A total of 576 lesions were examined. Although absolute δLI-drop during RF applications was significantly larger for the SP than MiFi-OI catheter (47[31-65]ohm for SP vs 37[24-51]ohm for MiFi-OI, p < 0.0001), %LI-drop was similar (23.3 [15.5-30.6]% in SP vs 24.9[17.3-32.5]% in MiFi-OI, p = 0.10). Although lesions produced by both catheters were similarly correlated with LI variation, the SP catheter produced generally larger lesions (depth; 5.0 [3.7-6.1]mm vs 4.7 [3.3-6.0]mm, p = 0.06; surface areas, 46.9 [36.8-58.8]mm2 vs 44.7 [34.3-55.5]mm2, p = 0.02; volume, 321 [165-533]mm3 vs 265[141-471]mm3, p = 0.02). Steam pops were similarly observed with both catheters. In both catheters, %LI-drop was superior to δLI-drop in correlation to lesion size (p < 0.0001) and in predicting steam pops (p < 0.01). Although no difference in safety profile is observed between MiFi-OI and SP catheters, the SP catheter produces larger lesions. %LI-drop is superior to δLI-drop in correlation to lesion size and in predicting steam pops as well as in normalizing the difference between catheters.

IDF21-0192 Preliminary findings of plantar stimulation combined with balance training on postural stability in diabetic neuropathy

Background: Diabetic peripheral neuropathy (DPN) is most common complication seen in the patients with type 2 diabetes mellitus. It is usually reduced sensation of plantar surface of foot. There are evidences demonstrate that patients with type 2 diabetes mellitus with DPN are associated with decline in postural stability in standing and increase risk of falls. Previous studies found that plantar electrical stimulation can improve plantar sensation. Recently, exercise is possibly an alternative intervention to improve balance in the adults. However, balance exercise is inappropriate for patients with type 2 diabetes mellitus with DPN who are impaired plantar sensation and concern about the potential risk of falls. However, no studies have explored whether plantar electrical stimulation combined with standing balance training has positive effects in patients with type 2 diabetes mellitus with DPN. Aim: The purpose of this pilot study was to determine the immediate and long-term effects of 4-week of plantar electrical stimulation combined with standing balance training on postural stability and walking ability in patients with type 2 diabetes mellitus with DP. Method: Four patients with type 2 diabetes mellitus with DPN were participated in this study. Each patient was completed plantar electrical stimulation combined with standing balance training 3 days per week for 4 weeks. Electrical stimulation (biphasic pulse current with a pulse duration of 0.1 ms, 100 Hz) was delivered via two self-adhesive surface electrodes for plantar of feet. The proximal electrode was placed over plantar forefoot area and the distal electrode was placed over plantar heel area. The current intensity was adjusted to produce tingling sensation without any discomfort. During plantar electrical therapy, each patient was performed simultaneously with standing balance training with both feet apart, feet together, tandem standing under eyes open and eyes closed conditions. Postural sway was assessed by total sway area using Lord’s sway meter during standing on 4 sensory conditions (eyes open and closed on a firm surface, eyes open and closed on a foam rubber mat) for 30 seconds of each condition. The walking ability was assessed by 10-meter walk test (10MWT) at preferred speed and maximum speed. All outcome measures were assessed before training, after 4-week training and 2-week follow-up. Results: Four weeks after training, all patients showed decreased total sway area during standing on 4 sensory conditions and increased walking speed on preferred and maximum conditions. Moreover, the results showed a trend toward decreased total sway area during standing on 4 sensory conditions and increased walking speed at 2-week follow-up period. Discussion: The findings from this pilot study showed that the immediate and long-term effects of 4-week of plantar electrical stimulation combined with standing balance training could help to improve postural stability and walking speed in patients with type 2 diabetes mellitus with DPN. This present method might be use as method for improving postural stability and reducing risk of falls in patients with type 2 diabetes mellitus with DPN. However, large sample sizes are still needed to confirm the finding in further study.

ACUTE PACING THRESHOLD ELEVATION DURING SIMULTANEOUS L0EADLESS PACEMAKER IMPLANTATION AND ATRIOVENTRICULAR NODE ABLATION

BACKGROUND In patients with refractory atrial fibrillation (AF) rate control strategy, atrioventricular node (AVN) ablation and permanent pacemaker implantation is recommended. The Micra Transcatheter Pacing System (TPS) is a single chamber leadless pacemaker implanted from the femoral vein and thus offers the possibility of AVN ablation in the same procedure. Here, we describe two cases of acute Micra TPS ventricular pacing threshold elevation immediately following radiofrequency AVN ablation at distance from the TPS requiring device retrieval and re-implantation of new Micra systems. METHODS AND RESULTS All consecutive patients with a Micra TPS implantation, at a single center, from November 2014 to March 2020, were analyzed retrospectively (n=56). Among them, 36% had a prior complication from a transvenous implant and in 16% lead extraction was performed concurrently with the TPS implantation. A total of ten patients (18%) underwent AVN ablation within the same procedure. Among them, two (20%) presented acute increase in the right ventricular pacing threshold after radiofrequency delivery requiring retrieval of the initial TPS and deployment of a new device. The first case was a 48 years-old man with previous heart transplantation. A Micra TPS was implanted in a mid-septal position (threshold 0,5 Volts x 0,24 milliseconds; impedance 800 Ohms; correct pull and hold test). To obtain a complete atrioventricular block, a retrograde arterial approach with an 8 mm nonirrigated catheter (60 degrees Celsius for 294 seconds) was required. After RF delivery, a loss of capture was observed. The second case included a 69 years-old woman. The TPS was implanted at an apico-septal position (Threshold 0,75 Volts x 0,24 milliseconds; impedance 720 Ohms; correct pull and hold test). The AVN ablation was achieved (52 degrees Celsius for 136 seconds) with a 4 mm nonirrigated catheter. Immediately, a threshold elevation >2 Volts x 0,24 milliseconds was observed. In both cases, continuous fluoroscopic control confirmed no direct interaction between the ablation catheter and the TPS. The device was successfully recaptured, and a new leadless PPM was immediately implanted with good results in these two cases. CONCLUSION We described two cases of acute threshold elevation during a combined procedure of TPS implantation and AVN ablation. This complication was not reported in series assessing safety of combining AVN ablation and Micra TPS implantation. We hypothesize a possible shunt of current to the distal electrode. An in vitro study is currently underway to explain the mechanism of indirect interaction between radiofrequency delivery and Micra TPS dysfunction. In patients with refractory atrial fibrillation (AF) rate control strategy, atrioventricular node (AVN) ablation and permanent pacemaker implantation is recommended. The Micra Transcatheter Pacing System (TPS) is a single chamber leadless pacemaker implanted from the femoral vein and thus offers the possibility of AVN ablation in the same procedure. Here, we describe two cases of acute Micra TPS ventricular pacing threshold elevation immediately following radiofrequency AVN ablation at distance from the TPS requiring device retrieval and re-implantation of new Micra systems. All consecutive patients with a Micra TPS implantation, at a single center, from November 2014 to March 2020, were analyzed retrospectively (n=56). Among them, 36% had a prior complication from a transvenous implant and in 16% lead extraction was performed concurrently with the TPS implantation. A total of ten patients (18%) underwent AVN ablation within the same procedure. Among them, two (20%) presented acute increase in the right ventricular pacing threshold after radiofrequency delivery requiring retrieval of the initial TPS and deployment of a new device. The first case was a 48 years-old man with previous heart transplantation. A Micra TPS was implanted in a mid-septal position (threshold 0,5 Volts x 0,24 milliseconds; impedance 800 Ohms; correct pull and hold test). To obtain a complete atrioventricular block, a retrograde arterial approach with an 8 mm nonirrigated catheter (60 degrees Celsius for 294 seconds) was required. After RF delivery, a loss of capture was observed. The second case included a 69 years-old woman. The TPS was implanted at an apico-septal position (Threshold 0,75 Volts x 0,24 milliseconds; impedance 720 Ohms; correct pull and hold test). The AVN ablation was achieved (52 degrees Celsius for 136 seconds) with a 4 mm nonirrigated catheter. Immediately, a threshold elevation >2 Volts x 0,24 milliseconds was observed. In both cases, continuous fluoroscopic control confirmed no direct interaction between the ablation catheter and the TPS. The device was successfully recaptured, and a new leadless PPM was immediately implanted with good results in these two cases. We described two cases of acute threshold elevation during a combined procedure of TPS implantation and AVN ablation. This complication was not reported in series assessing safety of combining AVN ablation and Micra TPS implantation. We hypothesize a possible shunt of current to the distal electrode. An in vitro study is currently underway to explain the mechanism of indirect interaction between radiofrequency delivery and Micra TPS dysfunction.

Pudendal Nerve Block by Low-Frequency (≤1 kHz) Biphasic Electrical Stimulation

To test the hypothesis that poststimulation block of nerve conduction can be achieved by low-frequency (≤1kHz) biphasic stimulation (LFBS). A tripolar cuff electrode was placed around the pudendal nerve in cats to deliver LFBS (1kHz, 500Hz, and 100Hz). Two bipolar hook electrodes were placed central and distal to the cuff electrode to induce external urethral sphincter (EUS) contractions. A catheter was inserted into the urethra to record EUS contraction pressure. Pudendal nerve block by LFBS was confirmed by the failure of the central hook electrode stimulation to induce EUS contractions, while the distal hook electrode stimulation still induced contractions. Pudendal nerve conduction was completely blocked by LFBS at different frequencies (1kHz, 500Hz, and 100Hz) after terminating LFBS. The post-LFBS block induced at the minimal stimulation intensity and duration was fully reversible within the same time period (10-15 min on average) for the three frequencies. However, the stimulation duration to induce block significantly (p < 0.05) increased from 23 ± 8sec to 95 ± 14 sec when frequency increased from 100Hz to 1kHz. This study discovered that LFBS (≤1kHz), like high-frequency (≥5kHz) biphasic stimulation (HFBS), can induce poststimulation block. The result provides support for the theory that biphasic stimulation waveforms block axonal conduction by changing intracellular and extracellular ion concentrations. The post-LFBS block provides the opportunity to develop new neuromodulation devices for clinical applications where initial nerve firing is acceptable.

Determining EMC Test Levels for Implantable Devices in Bipolar Lead Configuration

Certain low-frequency magnetic fields cause interference in implantable medical devices. Electromagnetic compatibility (EMC) standards prescribe injecting voltages into a device under evaluation to simplify testing while approximating or simulating real-world exposure situations to low-frequency magnetic fields. The EMC standard ISO 14117:2012, which covers implantable pacemakers and implantable cardioverter defibrillators (ICDs), specifies test levels for the bipolar configuration of sensing leads as being one-tenth of the levels for the unipolar configuration. The committee authoring this standard questioned this testing level difference and its clinical relevance. To evaluate this issue of EMC test levels, we performed both analytical calculations and computational modeling to determine a basis for this difference. Analytical calculations based upon Faraday's law determined the magnetically induced voltage in a 37.6-cm lead. Induced voltages were studied in a bipolar lead configuration with various spacing between a distal tip electrode and a ring electrode. Voltages induced in this bipolar lead configuration were compared with voltages induced in a unipolar lead configuration. Computational modeling of various lead configurations was performed using electromagnetic field simulation software. The two leads that were insulated, except for the distal and proximal tips, were immersed in a saline-conducting media. The leads were parallel and closely spaced to each other along their length. Both analytical calculations and computational modeling support continued use of a one-tenth amplitude reduction for testing pacemakers and ICDs in bipolar mode. The most recent edition of ISO 14117 includes rationale from this study.

Determining EMC Test Levels for Implantable Devices in Bipolar Lead Configuration.

Certain low-frequency magnetic fields cause interference in implantable medical devices. Electromagnetic compatibility (EMC) standards prescribe injecting voltages into a device under evaluation to simplify testing while approximating or simulating real-world exposure situations to low-frequency magnetic fields. The EMC standard ISO 14117:2012, which covers implantable pacemakers and implantable cardioverter defibrillators (ICDs), specifies test levels for the bipolar configuration of sensing leads as being one-tenth of the levels for the unipolar configuration. The committee authoring this standard questioned this testing level difference and its clinical relevance. To evaluate this issue of EMC test levels, we performed both analytical calculations and computational modeling to determine a basis for this difference. Analytical calculations based upon Faraday's law determined the magnetically induced voltage in a 37.6-cm lead. Induced voltages were studied in a bipolar lead configuration with various spacing between a distal tip electrode and a ring electrode. Voltages induced in this bipolar lead configuration were compared with voltages induced in a unipolar lead configuration. Computational modeling of various lead configurations was performed using electromagnetic field simulation software. The two leads that were insulated, except for the distal and proximal tips, were immersed in a saline-conducting media. The leads were parallel and closely spaced to each other along their length. Both analytical calculations and computational modeling support continued use of a one-tenth amplitude reduction for testing pacemakers and ICDs in bipolar mode. The most recent edition of ISO 14117 includes rationale from this study.

Characteristics of pulmonary vein gaps through a novel local impedance algorithm at repeat AF ablation procedures: preliminary results from the CHARISMA registry

Abstract Funding Acknowledgements Type of funding sources: None. Background A high incidence of pulmonary vein (PV) reconnection has been reported in patients with clinical recurrences of AF. Detailed characterization of PV gaps in terms of local impedance (LI) is still lacking. Purpose to characterize PV gaps with a novel local impedance algorithm during redo PV ablation in AF patients (pts). Methods Consecutive pts undergoing repeated AF ablation from the CHARISMA registry with complete characterization of PV gaps through local impedance at 6 Italian centers were included. A complete map of the left atrium and PVs was performed prior and after ablation through the Rhythmia mapping system. A novel RF ablation catheter with dedicated algorithm (DirectSense) was used to measure LI at the distal electrode of this catheter. Each gap was characterized in terms of LI and its variations during ablation procedure according to different ablation sites around the PVs. 7 sites around the left and right pair of PV for LI evaluation during ablation were defined: 2 for posterior sites (PS) (posterior inferior and posterior superior), 2 for anterior sites (AN) (anterior inferior and anterior superior), 1 for interior site (INF), 1 for superior site (SUP) and 1 for the carina (CAR). Ablation endpoint was PVI as assessed by entrance and exit block. Results Eighteen cases of redo AF ablation were analyzed (9 after prior RF ablation, 9 after prior cryoablation). A total of 41 PV gaps were detected (20 after RF ablation, 21 after cryoablation; mean number of gaps per pt = 2.3 ± 1.1): one gap was identified In five (27.8%) pts, 2 gaps were present in 7 (38.9%) pts, 3 gaps were detected in 2 (11.1%) pts and 4 gaps were identified in the remaining 4 (22.2%) pts. PV gaps were most common at AN sites (17, 41.5%), followed by PS sites (12, 29.3%) and CAR sites (11, 28.6%). The mean LI at gap sites was 113.9 ± 15Ω prior to ablation: it was significantly higher than LI at scar tissue closer to gap (99.7 ± 8Ω, p &amp;lt; 0.0001) but was significantly lower than LI at healthy tissue (120.2 ± 12Ω, p &amp;lt; 0.0001). LI parameters did not differ between prior ablation approach (RF vs Cryo: 115.5 ± 13Ω vs 112.2 ± 16Ω for LI at gap, p = 0.4739; 102.2 ± 6Ω vs 97.3 ± 10Ω LI at scar tissue, p = 0.0591; 16.4 ± 4Ω vs 15.8 ± 13Ω for LI drop at gap, p = 0.6647). In 14 cases (34.1%) the difference between LI at healthy tissue and LI at gap was lower than 5Ω, suggesting that this spot was not treated by RF or Cryo delivery in the previous ablation session (13 out 21 after Cryo ablation vs 1 out 20 after RF ablation, p &amp;lt; 0.0001). No complications during the procedures were reported. The acute procedural success was 100%, with all PVs successfully isolated in all study patients. Conclusion In our preliminary experience, PV gaps after failed PVI were most common at anterior, followed by posterior and carina sites. LI characteristics at PV gaps significantly differ from both scar and healthy tissue and could be used to target ablation deliveries.

Optimized radiofrequency lesions through local impedance guidance for effective cavo-tricuspid isthmus ablation in typical right atrial flutter: data from the CHARISMA registry

Abstract Funding Acknowledgements Type of funding sources: None. Background Radiofrequency (RF) catheter ablation of the cavo-tricuspid isthmus (CTI) is an established treatment for typical right atrial flutter (RAFL). However, whether local tissue impedance (LI) is able to predict effective CTI ablation and what LI drop values during ablation should be used to judge a lesion as effective remains to be established. Purpose We aimed to investigate the ability of LI to predict ablation efficacy in patients (pts) with RAFL and to characterize the CTI in terms of LI. Methods Consecutive pts undergoing RAFL ablation from the CHARISMA registry were enrolled at 9 centers. A novel RF ablation catheter with dedicated algorithm (DirectSense - DS -) was used to measure LI at the distal electrode of this catheter. RF applications (RFC) were targeted to a minimum LI drop of 10 Ω within 30 seconds and were stopped when a maximum cutoff LI drop of &amp;lt;40 Ω was observed. Successful single RFC was defined according with a split in two separate potentials (SPL), reduction of voltage (RedV) by at least 50% or changes at unipolar EGM (UPC). Agreement among criteria was evaluated. Ablation endpoint was the creation of bidirectional conduction block (BDB) across the isthmus. Results A total of 279 ablation spot lesions were delivered in 30 pts (mean RFC 9 ± 6 lesions per pt): 106 (38%) at anterior, 115 (41%) at mid and 58 (21%) at posterior portions of the CTI. BDB was obtained in all cases and no complications were observed. The median RFC delivery time was 30 [19–45] seconds per lesion. 132 (47%), 150 (54%) and 86 (31%) ablation spots were effective according with SPL, RedV and UPC, respectively. Complete agreement of all the criteria was reached in 70% of the cases. The mean LI was 104.4 ± 11Ω prior to ablation and 92.1 ± 11Ω after ablation (p &amp;lt; 0.0001, mean absolute LI drop 12.2 ± 7Ω, mean time to LI drop 13 ± 8 seconds). Effective ablation spots showed a higher LI drop compared with ineffective sites at each single criteria (16.6 ± 7Ω vs 8.3 ± 4Ω for SPL, p &amp;lt; 0.0001; 16.1 ± 6Ω vs 7.8 ± 5Ω at for RedV, p &amp;lt; 0.0001; 19 ± 6Ω vs 9.2 ± 4Ω for UPC, p &amp;lt; 0.0001) and LI drop values significantly increase according to the number of criteria satisfied (ranging from 7.5Ω % -no criteria- to 19.1 -all criteria-). A 15Ω cut-off value for LI (AUC 0.91, sensitivity = 67%, specificity = 92%, p &amp;lt; 0.0001) was associated with the achievement of all criteria with an OR of 21.9 (95%CI: 11.1 to 43.5, p &amp;lt; 0.0001) and a positive predictive value of 76%. Starting LI and LI drop seem to be higher at mid-septal areas. Conclusion In our preliminary experience, a LI-guided approach of CTI seems to be safe and effective in RAFL ablation. The magnitude of LI drop was associated with effective lesion formation and conduction block and could be used as a marker of ablation efficacy.

Partial high frequency nerve block decreases neuropathic signaling following chronic sciatic nerve constriction injury

Objective. High frequency (HF) block can quickly and reversibly stop nerve conduction. We hypothesized HF block at the sciatic nerve would minimize nociception by preventing neuropathic signals from reaching the central nervous system. Approach. Lewis rats were implanted with a constriction cuff and a distal cuff electrode around their right sciatic nerve. Tactile sensitivity was evaluated using the 50% paw withdrawal threshold (PWT) determined using Chaplan’s method for von Frey monofilaments. Over the course of 49 d, the 50% PWT was measured (1) before HF block, (2) during HF block (50 kHz, 3 V pp), and (3) after HF block. Gait was observed and scored before and during block. At end point, HF block efficacy was directly evaluated using additional cuff electrodes to elicit and record compound neural action potentials across the HF blocking cuff. Main results. At days 7 and 14 d post-operation, tactile sensitivity was significantly lower during HF block compared to before and after block (p< 0.005). Additionally, an increase in gait disability was not visually observed during HF block. Significance. HF block can reduce tactile sensitivity in a limb with a neuropthic injury in a rapidly reversible fashion.

Electrodes’ Configuration Influences the Agreement Between Surface EMG and B-Mode Ultrasound Detection of Motor Unit Fasciculation

Muscle fasciculations, resulting from the spontaneous activation of motor neurons, may be associated with neurological disorders, and are often assessed with intramuscular electromyography (EMG). Recently, however, both ultrasound (US) imaging and multichannel surface EMG have been shown to be more sensitive to fasciculations. In this study we combined these two techniques to compare their detection sensitivity to fasciculations occurring in different muscle regions and to investigate the effect of EMG electrodes' configuration on their agreement. Monopolar surface EMGs were collected from medial gastrocnemius and soleus with an array of 32 electrodes (10 mm Inter-Electrode Distance, IED) simultaneously with b-mode US images detected alongside either proximal, central or distal electrodes groups. Fasciculation potentials (FP) were identified from single differential EMGs with 10 mm (SD1), 20 mm (SD2) and 30 mm (SD3) IEDs, and fasciculation events (FE) from US image sequences. The number, location, and size of FEs and FPs in 10 healthy participants were analyzed. Overall, the two techniques showed similar sensitivities to muscle fasciculations. US was equally sensitive to FE occurring in the proximal and distal calf regions, while the number of FP revealed by EMG increased significantly with the IED and was larger distally, where the depth of FE decreased. The agreement between the two techniques was relatively low, with a percentage of fasciculation classified as common ranging from 22% for the smallest IED to 68% for the largest IED. The relevant number of events uniquely detected by the two techniques is discussed in terms of different spatial sensitivities of EMG and US, which suggest that a combination of US-EMG is likely to maximise the sensitivity to muscle fasciculations.

AC Pulsed Field Ablation Is Feasible and Safe in Atrial and Ventricular Settings: A Proof-of-Concept Chronic Animal Study.

IntroductionPulsed field ablation (PFA) exploits the delivery of short high-voltage shocks to induce cells death via irreversible electroporation. The therapy offers a potential paradigm shift for catheter ablation of cardiac arrhythmia. We designed an AC-burst generator and therapeutic strategy, based on the existing knowledge between efficacy and safety among different pulses. We performed a proof-of-concept chronic animal trial to test the feasibility and safety of our method and technology.MethodsWe employed 6 female swine – weight 53.75 ± 4.77 kg – in this study. With fluoroscopic and electroanatomical mapping assistance, we performed ECG-gated AC-PFA in the following settings: in the left atrium with a decapolar loop catheter with electrodes connected in bipolar fashion; across the interventricular septum applying energy between the distal electrodes of two tip catheters. After procedure and 4-week follow-up, the animals were euthanized, and the hearts were inspected for tissue changes and characterized. We perform finite element method simulation of our AC-PFA scenarios to corroborate our method and better interpret our findings.ResultsWe applied square, 50% duty cycle, AC bursts of 100 μs duration, 100 kHz internal frequency, 900 V for 60 pulses in the atrium and 1500 V for 120 pulses in the septum. The inter-burst interval was determined by the native heart rhythm – 69 ± 9 bpm. Acute changes in the atrial and ventricular electrograms were immediately visible at the sites of AC-PFA – signals were elongated and reduced in amplitude (p < 0.0001) and tissue impedance dropped (p = 0.011). No adverse event (e.g., esophageal temperature rises or gas bubble streams) was observed – while twitching was avoided by addition of electrosurgical return electrodes. The implemented numerical simulations confirmed the non-thermal nature of our AC-PFA and provided specific information on the estimated treated area and need of pulse trains. The postmortem chest inspection showed no peripheral damage, but epicardial and endocardial discolorations at sites of ablation. T1-weighted scans revealed specific tissue changes in atria and ventricles, confirmed to be fibrotic scars via trichrome staining. We found isolated, transmural and continuous scars. A surviving cardiomyocyte core was visible in basal ventricular lesions.ConclusionWe proved that our method and technology of AC-PFA is feasible and safe for atrial and ventricular myocardial ablation, supporting their systematic investigation into effectiveness evaluation for the treatment of cardiac arrhythmia. Further optimization, with energy titration or longer follow-up, is required for a robust atrial and ventricular AC-PFA.

Standardized fluoroscopy-guided implantation technique enables optimal electrode placement in sacral neuromodulation: a cadaver study

BackgroundSacral neuromodulation (SNM) is an established treatment option for patients with faecal incontinence. The location of the stimulating electrode is considered to be essential for treatment success. The purpose of this study was to evaluate the position of SNM electrodes after using a standardized fluoroscopy-guided implantation technique.MethodsFor this cadaver study, SNM electrodes were implanted bilaterally in 5 lower body specimens. The lower edge of the sacroiliac joint and the medial edge of the sacral foramina were marked using fluoroscopy to draw an ‘H’ with the crossing points identifying S3. After electrode placement the pelvis was dissected to describe the exact position of the SNM electrodes.ResultsThe electrodes were inserted at an angle with a median degree measure of 60° (range 50–65°) to the skin, with a median distance of 9 mm (range 0–13 mm) from the S3 marking. All electrodes entered the third sacral foramen. The median distance of the electrodes to the sacral nerve was 0 mm (range 0–3 mm) for the most proximal, 0.5 mm (range 0–5 mm) for the second, 2.25 mm (range 0–11 mm) for the third and 1.75 mm (range 0–16 mm) for the most distant electrode. There was neither a significant difference in the proximity of the electrodes to the nerve between the right and left side (proximal to distal electrode: p = 0.18, p = 0.16, p = 0.07, p = 0.07) nor between male and female cadavers (p = 0.25, p = 0.21, p = 0.66, p = 0.66).ConclusionsA standardized fluoroscopy-guided implantation technique enables a close contact between electrode and nerve. This can potentially result in an improved clinical outcome.

Left coronary cusp ablation to eliminate epicardial substrates – a novel strategy for left ventricular summit ventricular tachycardia ablation

Abstract Background Catheter ablation of LV summit VT can be challenging due to possible subepicardial or intramural site of origin and its close proximity to the major coronary vessels. Objective Local electrograms monitoring inside LV summit communicating vein potentially defines arrhythmogenic substrates and facilitates ablation from the adjacent anatomical structures. Results We experienced two cases of LV summit VT with epicardial local abnormal ventricular activities (Epi-LAVA) recorded from distal bipolar electrode of the 2F microcatheter in communicating vein close to the superior portion of LV summit. During sinus rhythm, Epi-LAVA displayed isolated late fractionated potentials in the first case but had initial fractionated potentials fused with terminal portion of far-field ventricular signals and late isolated potentials exhibiting 2:1 conduction in the second case. Epi-LAVA represented earliest ventricular signals during VT in both cases. Pace mapping at Epi-LAVA sites yielded single QRS morphology with excellent pacemap score and induced VT. Our strategy was to perform ablation at the facing site of Epi-LAVA aiming to eliminate the potentials transmurally. Radiofrequency (RF) energy was applied above and under the left coronary cusp opposite to Epi-LAVA sites using 3.5-mm tip open-irrigation catheter with a power of 30–35 W for 60 seconds under real-time intracardiac echocardiograhic guidance. VT was slowed and terminated in 1 second. Repeat ablation delayed and completely abolished Epi-LAVA followed by noninducibility of VT. Anatomical proximity of the left coronary cusp semilunar insertion and subepicardial or intramural site of origin possibly dictates successful ablation. Epi-LAVA from coronary vein mapping serve as a new landmark of the ablation target with a measurable procedural endpoint. Conclusion Elimination of epicardial substrates with RF energy application at the left coronary cusp can be a novel strategy for LV summit VT ablation. Funding Acknowledgement Type of funding source: None

A novel local impedance algorithm to guide effective pulmonary vein isolation in AF patients: 1-year outcome from the CHARISMA Study

Abstract Background Recently, a novel technology able to measure local tissue impedance (LI) providing a measure of tissue characteristics aimed at validating confidently ablation endpoints has become available for clinical use. Purpose We report the outcomes of our acute and long-term clinical evaluation of this algorithm in consecutive atrial fibrillation ablation cases. Methods Consecutive patients (pts) undergoing AF ablation at 6 Italian centers were included in the CHARISMA registry. A novel RF ablation catheter and a dedicated algorithm were used to measure LI through the distal catheter's electrode. The ablation was guided by looking at the magnitude and time course of impedance drop during RF delivery. The maximum distance between each ablation spot (center-to-center) was suggested to be ≤4 mm. RF applications were targeted to a LI drop of 10 Ω and RF applications were stopped when a maximum cutoff LI drop of &amp;lt;40 Ω was observed. Successful single RF ablation was defined according with a reduction of signal voltage (RedV) by at least 50% and inability to capture local tissue on pacing. Ablation endpoint was PVI as assessed by entrance and exit block. Post-ablation, all pts were monitored with ambulatory event monitoring, as well as Holter monitoring at 3, 6, and 12 months post-ablation. Additional ECG monitoring was performed as indicated by patient symptoms. Results A total of 1914 point by point first pass RF applications &amp;gt;10 s performed around PVs were analyzed from 98 pts (mean age = 61±11 years, 69% male, 55% paroxysmal AF, 45% persistent AF, 60% de novo procedures, 40% redo procedures). The mean LI was 105±15Ω prior to ablation and 92±13Ω after ablation (p&amp;lt;0.0001, mean absolute LI drop of 12.7±8Ω) during a median RF delivery time of 22 [17–31] sec. Effective ablation spots (88%) showed a higher absolute impedance drop (13.6±8Ω at effective RedV vs 6±3Ω at ineffective RedV, p&amp;lt;0.0001) compared with ineffective sites (12%). No steam pops or complications, including atrio-esophageal fistula or tamponade were reported during or after the procedures. At the end of the procedures all PVs were successfully isolated in all study pts. During a median follow-up of 369 [287–446] days, 13 pts (13.2%) developed an AF/AT recurrence after the 90-days blanking period (9.2% with paroxysmal vs 18% with persistent AF, p=0.239; 8.5% for de novo vs 20.5% for redo procedures, p=0.127). The time to recurrence was comparable among AF type (HR=1.97; 0.66 to 5.86; log-rank p=0.2265 for persistent vs paroxysmal AF) and procedural type (HR=2.56; 0.84 to 7.82; log-rank p=0.087 for redo vs de novo procedure) Conclusions In our experience, the magnitude of the LI drop during RF delivery was associated with effective lesion formation. An ablation strategy for PVI guided by LI technology was safe and effective, and resulted in a very low recurrence rate of AF at 1-year follow-up irrespective of paroxysmal/persistent AF type or de novo/redo procedure. Funding Acknowledgement Type of funding source: None

Real-time local impedance monitoring to assess tissue lesion during pulmonary vein isolation: a new tool for AF ablation

Abstract Background Contact force catheter ablation is the gold standard for treatment of atrial fibrillation (AF). Local tissue impedance (LI) evaluation has been recently studied to evaluate lesion formation during radiofrequency ablation. Purpose Aim of the study was to assess the outcomes of an irrigated catether with LI alghorithm compared to contact force (CF)-sensing catheters in the treatment of symptomatic AF. Methods A prospective, single-center, nonrandomized study was conducted, to compare outcomes between CF-AF ablation (Group 1) and LI-AF ablation (Group 2). For Group 1 ablation was performed using the Carto 3© System with the SmartTouch SF catheter and, as ablation target, an ablation index value of 500 anterior and 400 posterior. For Group 2, ablation was performed using the Rhythmia™ System with novel ablation catheter with a dedicated algorithm (DirectSense) used to measure LI at the distal electrode of this catheter. An absolute impedance drop greater than 20Ω was used at each targeted. According to the Close Protocol, ablation included a point by point pulmonary vein isolation (PVI) with an Inter-lesion space ≤5 mm in both Groups. Procedural endpoint was PVI, with confirmed bidirectional block. Results A total of 116 patients were enrolled, 59 patients in Group 1 (CF) and 57 in Group 2 (LI), 65 (63%) with a paroxismal AF and 36 (37%) with a persistent AF. Baseline patients features were not different between groups (P=ns). LI-Group showed a comparable procedural time (180±89 vs 180±56, P=0.59) but with a longer fluoroscopy time (20±12 vs 13±9 min, P=0.002). Wide antral isolation was more often observed in CF-Group (95% vs 80%, P=0.022), while LI-Group 2 required frequently additional right or left carina ablation (28% vs 14%, P=0.013). The mean LI was 106±14Ω prior to ablation and 92.5±11Ω after ablation (mean LI drop of 13.5±8Ω) during a median RF time of 26 [19–34] sec for each ablation spot. No steam pops or complications during the procedures were reported. The acute procedural success was 100%, with all PVs successfully isolated in all study patients. Regarding safety, only minor vascular complications were observed (5%), without differences between groups (p=0.97). During follow up, 9-month freedom from atrial fibrillation/atrial flutter/atrial tachycardia recurrence was 86% in Group 1 and 75% in Group 2 (P=0.2). Conclusions An LI-guided PV ablation strategy seems to be safe and effective, with acute and mid-term outcomes comparable to the current contact force strategy. LI monitoring could be a promising complementary parameter to evaluate not only wall contact but also lesion formation during power delivery. Procedural Outcomes Funding Acknowledgement Type of funding source: None

Interleaved intramuscular stimulation with minimally overlapping electrodes evokes smooth and fatigue resistant forces

Objective. It is known that multi-site interleaved stimulation generates less muscle fatigue compared to single-site synchronous stimulation. However, in the limited number of studies in which intramuscular electrodes were used, the fatigue reduction associated with interleaved stimulation could not consistently be achieved. We hypothesize that this could be due to the inability to place the intramuscular electrodes used in interleaved stimulation in locations that minimize overlap amongst the motor units activated by the electrodes. Our objective in the present study was to use independent intramuscular electrodes to compare fatigue induced by interleaved stimulation with that generated by synchronous stimulation at the same initial force and ripple. Approach. In the medial gastrocnemius muscle of an anesthetized rabbit (n = 3), ten intramuscular hook wire electrodes were inserted at different distances from the nerve entry. Overlap was measured using the refractory technique and only three electrodes were found to be highly independent. After ensuring that forces obtained by both stimulation modalities had the same ripple and magnitude, fatigue induced during interleaved stimulation across three independent distal electrodes was compared to that obtained by synchronously delivering pulses to a single proximal electrode. Main results. Contractions evoked by interleaved stimulation exhibited less fatigue than those evoked by synchronous stimulation. Twitch force recruitment curves collected from each of the ten intramuscular electrodes showed frequent intermediate plateaus and the force value at these plateaus decreased as the distance between the electrode and nerve entry increased. Significance. The results indicate that interleaved intramuscular stimulation is preferred over synchronous intramuscular stimulation when fatigue-resistant and smooth forces are desired. In addition, the results suggest that the large muscle compartments innervated by the primary intramuscular nerve branches give rise to progressively smaller independent compartments in subsequent nerve divisions.

Electrode Placement Strategies for the Measurement of Radial Artery Bioimpedance: Simulations and Experiments

Continuous cardiac output is a significant matter that must be considered in monitoring the functioning of cardiovascular system. A noninvasive sensing system that is based on measuring electrical bioimpedance variations of radial artery is proposed to evaluate the physical condition of a patient. To optimize the signal acquisition, different electrode placement strategies are compared with the goal of finding the most suitable ones. The finite-element method (FEM) simulation of sensitivity distribution and experimental measurements on radial artery are performed for experimenting circular and distal electrode placements. Importantly, also the modified electrode placement strategies, guided by the idea of focused impedance method (FIM), are investigated. To reduce the number of electrodes in measurement setup, its novel version is proposed: a five-electrode FIM strategy. The efficiency of the proposed strategy can be seen in the reduced amount of required number of electrodes: the smaller area of electrode-skin contact interface results in smaller influence of uncertainties. Moreover, the reduced number of electrodes contributes to benefit through developing simpler instrumentation having lower energy consumption and cheaper manufacturing costs. The results show the advances of the proposed novel five-electrode FIM strategy for measuring the pulsating volume of blood in radial artery with the goal of determining the central aortic pressure (CAP) of blood.

45Improving the optimization of cardiac resynchronization therapy: Does multipoint left ventricular pacing shorten the paced-QRS duration compared to the fusion-optimized intervals method?

Abstract Funding Acknowledgements Cardiac Pacing Scholarship from the Spanish Society of Cardiology (SEC) Background Electrocardiogram-based optimization of cardiac resynchronization therapy (CRT) using the fusion-optimized intervals (FOI) method has demonstrated to improve both acute hemodynamic response and left ventricle (LV) reverse remodeling compared to nominal programming of CRT. FOI optimizes the atrioventricular (AV) and ventriculo-ventricular (VV) intervals to achieve the shortest paced-QRS duration. The recent development of multipoint pacing (MPP) enables the activation of the LV from 2 locations, also shortening the QRS duration compared to conventional biventricular pacing. Purpose To determine if MPP reduces the paced-QRS duration compared to FOI optimization. Methods This prospective clinical study included 25 consecutive patients who successfully received a CRT with MPP pacing capability. All patients were in sinus rhythm and had an PR interval below 250 ms. The QRS duration was measured with a 12-lead digital electrocardiography (screen speed of 200 mm/s) at baseline and using 3 different configurations: MPP, FOI and a combined FOI-MPP strategy. In MPP, the intervals were (based on previous studies): 1) AV 130 ms, 2) Right ventricular (RV)-LV2 (Δ1) 5 ms, and 3) LV1-LV2 (Δ2) 5 ms. In FOI, AV and VV intervals were optimized to achieve fusion between intrinsic conduction and biventricular pacing. In FOI-MPP, the Δ2 was set at 5 ms, while AV and Δ1 intervals were optimized using the FOI method. The CRT device was programmed with the configuration that achieved a greater paced-QRS shortening. After 45 days, battery life was estimated. Results Mean age was 65 ± 10 years, 20 were men (80%) and baseline QRS duration was 177 ± 17 ms. The FOI method bested nominal MPP (QRS shortened by 58 ± 16 ms vs 43 ± 16 ms, respectively, p = 0.002). Adding MPP to the narrowest QRS by FOI did not result in further shortening (FOI: 58 ± 16 ms vs FOI-MPP: 59 ± 13 ms, p = 0.81). The final configuration was FOI method alone in most cases (n = 16, 64%) and FOI-MPP in all others (n = 9, 36%; figure). In total, 10 out of 25 patients (40%) were not candidates to MPP due to: 1) pacing thresholds exceeding 3.5 V/0.4 ms at the distal or proximal electrode (8, 32%), and 2) phrenic stimulation (2, 8%). Estimated battery longevity was longer in patients receiving FOI as compared to MPP (8.3 ± 2.1 years vs. 6.2 ± 2.2 years, p = 0.04). Conclusion In CRT, the FOI method is not improved by coupling with MPP. Up to 40% of patients are not candidates for MPP due to high thresholds or phrenic stimulation. The use of MPP in unselected patients would result in a decrease of battery longevity, without any additional benefit over FOI. Abstract Figure.

P1447Use of novel local impedance-based catheter in typical right atrial flutter ablation: preliminary data from a multicenter Italian study

Abstract Funding Acknowledgements NO FUNDING Background Many studies demonstrated the importance of an optimal tissue contact to obtain safe and effective lesions and to improve the clinical outcome in ablation of cavotricuspid isthmus (CTI) for typical right atrial flutter (AFL). Data about a novel technology able to measure local tissue impedance (LI) providing a measure of tissue characteristics and lesion formation is still lacking in right atrium or CTI working. Purpose This analysis explores the relationship between LI measures and ablation spot lesion locations during ablation of CTI in common AFL patients (pts). Methods Consecutive pts undergoing AFL ablation from the CHARISMA registry were included. A novel RF ablation catheter with dedicated algorithm (DirectSense - DS -) was used to measure LI at the distal electrode of this catheter. Each targeted spot was characterized in terms of LI parameters during RF delivery at the lateral, intermediate and posterior portions of the CTI. Successful single RF ablation was defined according with a reduction of voltage (RedV) by at least 50% or split in two separate potentials (SPL). Ablation endpoint was the creation of bidirectional conduction block across the isthmus. Results A total of 135 ablation spot lesions were delivered in 20 pts (median 5 [3-11] lesions per pt): 7 (5%) at lateral, 88 (65%) at intermediate and 40 (30%) at posterior portions of the CTI. Acute success was obtained in all cases and no complications were observed. The median ablation time was 26 [17 – 36] seconds per lesion. 100 (74%) and 51 (38%) ablation spots were effective according with RedV or SPL, respectively. The mean LI was 106 ± 15Ω prior to ablation and 93 ± 13Ω after ablation (p &amp;lt; 0.0001, mean absolute LI drop 14 ± 7Ω, mean percentage LI drop 13%±6). Effective ablation spots showed a higher absolute impedance drop (15 ± 7Ω at effective RedV vs 9.6 ± 8Ω at ineffective RedV, p = 0.0001; 15.6 ± 7Ω at effective SPL vs 12.5 ± 7Ω at ineffective SPL, p = 0.0173) or % impedance drop (14%±6 at effective RedV vs 9%±7 at ineffective RedV, p &amp;lt; 0.0001; 14.5%±6 at effective SPL vs 11.6%±6 at ineffective SPL, p = 0.0103) compared with ineffective sites. No significant differences were found in terms of starting LI, ending LI or LI drop among CTI areas. The percentage of LI drop was associated both with RedV (odd ratio 1.17 (95%CI: 1.08 to 1.26, p = 0.0001)) and with SPL (odd ratio 1.08 (1.02 to 1.14, p = 0.0132)). Conclusion In our preliminary experience, measured LI before and after RF delivery and LI drop appear to be consistent and homogeneous across different CTI ablation locations. The magnitude of the LI drop was associated with effective lesion formation and conduction block.