Acute Procedural Complications Research Articles

Remote magnetic navigation for catheter ablation of complex arrhythmias in congenital heart disease: an initial experience using a transnational telerobotic approach

Abstract Background The field of congenital electrophysiology (EP) is still in its relative infacncy with a limited number of electrophysiologists capable of performing catheter ablation in patients with congenital heart disease (CHD). As a result, patients or physicians are often required to travel great distances to performed specialised ablation procedures, something made near impossible during the COVID-19 pandemic. Objective We aimed to explore the feasibility and safety of a telerobotic approach to catheter ablation where the remote operator was situated approximately 1200km away from the patient and local team. Methods A 3D-printed 'phantom' heart was used in a pilot experiment in which no significant difference was seen between the local and remote operators in electroanatomic (EAM) mapping of the phantom heart using remote magnetic navigation (RMN). Catheter ablation was subsequently performed in patients with severe CHD using a transnational telerobotic approach to catheter ablation where the remote operator was able to view the dedicated console with live fluoroscopy, EAM and EP signals, as well as control the mapping and ablation catheters from 1200km away. As a safety precaution, radiofrequency (RF) could only be delivered by the local team. Results In total, 10 procedures were performed in 9 patients with severe CHD (mean age 38) between April and December 2021. All patients underwent an atrial ablation and one additional non-CHD patient underwent denervation of the pulmonary arteries. Median procedure duration was 335 (minutes) (IWR 230-349) with 11.5 minutes (QRS 3-15.4) of fluoroscopy exposure and 752 (IQR 674-905) seconds of RF delivery. There were no acute procedural complications. At one-year follow-up, one patient died as a result of heart failure and there were two arrhythmia recurrences. Conclusions Telerobotic catheter ablation is feasible and effective and creates the possibility of exciting new approaches to remote ablation and its use in the tele-proctoring of international fellows.

Atrial fibrillation recurrence in oncocardiological patients treated with catheter ablation. A retrospective cohort study

Abstract Background The relationship between oncological events and cardiovascular pathologies is a subject still widely discussed. Certain chemotherapy drugs, including alkylating agents, anthracyclines, taxanes, and topoisomerase II inhibitors have proven to possess arrhythmic and cardiotoxic capabilities. There is enough evidence to suggest an association between oncological events and the appearance of newly onset AF, but there is little to no scientific literature about the management of these patients and the outcome of normal therapeutically procedures. Purpose This study assess if oncocardiological patients with AF should be considered a risk group when planning to undergo catheter ablation for the arrhythmia treatment. Methods The studied population was based on the data recollection from the electrophysiology department and consisted of patients with AF intervened by radiofrequency catheter ablation. All the procedures were conducted between January 1st 2019 and December 31st 2022. Among 138 participants enrolled for this study, 68 of them had either recent history of oncological events (maximum of 5 years cancer-free). The control group had no previous nor active history of cancer. The cohort with the desired exposure (cancer patients) was compared with a cancer-free group. Two primary outcomes were measured: procedure related complications, and first AF recurrence within the first 12 months. Complications were categorized according to two dichotomous variables: the existence of acute complications directly during the procedure or within the first 12 hours after the end of the procedure, and the occurrence of self-limited arrhythmic events during the blanking period. Results When compared as dichotomous variables (yes/no) with Fisher’s exact test, no statistical significance was observed between the studied cohort and control for complications and events during blanking. The proportion of patients free of sustained episodes of AF at 12 months was 52,9% in the oncologic group and 77,9% in the Control group (P = 0.003; RR of 3.14; 95% CI 1.5 - 6.6) for the oncologic group. When not adjusted by any other factor, association with Cancer was shown (HR 2.43; P =0.005; 95% CI 1.3 – 4.4) for recurrence of arrhythmic events. The regression model with Kaplan-Meier method shows the overall 12-month survival in two groups and the difference between the two survival curves was statistically significant (P=0.0016). Conclusion Oncocardiological patients have demonstrated a significantly higher incidence in post-ablational recurrence when compared with a similar cancer-free control group. Results found in acute and chronic procedural complications were similar in both cohorts.

The impact of clinical audits on patient radiation exposure for device procedures

Abstract Background Clinical audits aim to ensure ideal use of ionizing radiation in clinical practice. Since it became mandatory by Swiss law in 2018, such an audit also took place in our Cardiac Pacing and Electrophysiology Division at the University Heart Center. Purpose To establish local diagnostic reference levels (DRLs) for specific procedures and to examine if patient radiation exposure was reduced after the clinical audit. Methods Retrospective cohort study including patients from October 2018 to October 2020 who underwent device implantation, including pacemakers, implantable cardioverter defibrillators (ICD), cardiac resynchronization therapy (CRT), or lead extraction / device explantation. Main measures to reduce radiation exposure after the audit were lower pulsed fluoroscopy frame rates and dose characteristics at baseline. Patient radiation exposure was evaluated with the dose-area product (DAP), cumulative dose, fluoroscopy time, and the number of cine acquisitions. Secondary endpoints included the effective dose, the acute procedural success rate and 30-day complications. Data were collected from a dose management system and cross-checked for accuracy with the patient information system. The third quartiles were set as local DRLs. Data before and after the clinical audit were compared. Results A total of 541 patients (45.7 % before the audit, 54.3% after the audit) were included. 28.3% had a conventional pacemaker, 22.0% a leadless pacemaker, 21.1% an ICD, and 17.2% a CRT implantation. Lead extraction / device explantation was undergone by 11.5% of patients. The local DRLs (including all procedures before and after the audit) for the DAP were significantly lower as compared to national DRLs (6.2 dGy.cm2 versus 300 dGy.cm2 for conventional pacemakers; 7.6 dGy.cm2 versus 200 dGy.cm2 for ICDs, 203 dGy.cm2 versus 570 dGy.cm2 for CRTs). After the audit, DAP (Figure 1), cumulative dose, effective dose and the number of cine acquisition significantly decreased for conventional pacemakers (p-value ≤ 0.04), whereas no significant differences were observed for the other procedures. The acute procedural success rate (98.4 vs 98.9%) and the 30-day complications (4.0 vs 7.8%) were not significantly different before and after the audit. Conclusions The clinical audit in our institution led to a significant reduction of radiation exposure for patients during pacemaker implantations. Regarding DRLs, local values were far below national DRLs, which suggests that national DRLs need to be updated more regularly. Our study highlights the importance of clinical audits and the need for more research in this field.

Practical and systematic approach using the steerable catheter and stylet-driven lead to deliver safe and effective left bundle branch area pacing.

Current delivery tools were not designed for left bundle branch area pacing (LBBAP). Challenges using these tools include lack of reach into the right ventricle and poor support for the lead to penetrate the interventricular septum. Concerns using stylet-driven leads (SDL) for LBBAP have been previously highlighted. Knowledge and the technical know-how of using SDL for LBBAP need to be evaluated in a fair and consistent manner. A stepwise approach is devised for use of Agilis HisProTM steerable catheter with Tendril STS Model 2088TC lead for LBBAP and evaluated for safety and reproducibility. Consecutive patients undergoing LBBAP using the stepwise approach with Agilis HisProTM steerable catheter were analyzed. The safety, efficacy and reproducibility of the technique were evaluated. The lead parameters were analyzed in the immediate (1 day) and short-term period (3-6 months) post implantation. LBBAP was attempted in 41 patients using the stepwise approach of which 37 (90.7%) were successful. The lead parameters were stable in the immediate and short-term post implantation in all our patients. There was no significant difference between the group of patients with multiple repositioning of the lead compared to those successful at the 1st attempt. There were no acute or short-term lead and procedural complications. A stepwise and systematic approach using the Agilis HisProTM steerable catheter and proper handling of the Tendril STS Model 2088TC stylet-driven lead is an important part of the armamentarium to deliver LBBAP in a practical, effective and reproducible manner.

Transesophageal echocardiography-guided percutaneous closure of the patent foramen ovale only uses the sheath.

Percutaneous closure of the patent foramen ovale (PFO) is primarily guided by fluoroscopy in the catheter room, during which procedure both the guidewire and sheath need to pass through the PFO. We performed PFO closure using a transesophageal echocardiography (TEE)-guided approach and only the sheath was passed through the PFO during the procedure. This study aimed to evaluate the feasibility and safety of PFO closure using this technique. A retrospective observational study was performed. A total of 117 consecutive adult patients underwent percutaneous PFO closure without fluoroscopy, under the sole guidance of TEE in our hospital between December 2018 and December 2021. The data of each patient consisted of preoperative, operative, and postoperative variables collected. The primary outcome is that the occluder was successfully released. The secondary outcomes included perioperative and follow-up transthoracic echocardiography (TTE), Headache impact test-6 (HIT-6) score and clinical symptoms. Transvenous PFO closure under TEE guidance was successful in all cases. The sample consisted of 93 females and 24 males with an average age of 42.3±7.8 years. There were 28 patients with preoperative cerebral infarction [Risk of Paradoxical Embolism (RoPE) score >6 points] and 89 patients with migraine. All patients underwent a preoperative TEE to confirm the presence of PFO, and contrast-enhanced transcranial Doppler (c-TCD) acoustic contrast suggested grades 3 to 4. The average time of surgery for patients (puncture to removal of the sheath) was 32 minutes. Three cases of vagus nerve reflex manifestations during surgery and two cases of transient ventricular arrhythmia all improved after symptomatic treatment. There were no instances of metal allergy, hemolysis, or other acute vascular procedural complications. For all 89 patients with migraine, significant relief or resolution was achieved during the first six-month follow-up (P<0.001). As a monotherapy, percutaneous closure of PFO guided by TEE where only the sheath passes through the PFO during the operation is an effective procedure with a high success rate and a low complication rate.

Interventional electrophysiology in bulgaria in 2022: data from the electronic registry BG-EPHY

This study presents data from the national electronic registry BG-EPHY on electrophysiologic (EP) cardiac ablations in 2022. Material and methods: This is a retrospective study of a full one-year sample of the BG-EPHY registry. Sex and age distribution of the patients, number of ablations, use of electroanatomic mapping (EAM), irrigated and cryoablations, distribution of different types of arrhythmias, acute procedural success and complications are presented. Results: In 2022 seven EP centers performed 1369 ablations in 872 men (63.7%) and 497 women (57% increase compared to previous year), incl. 15 ablations in pediatric patients (1.1%). EAM was used in 746 procedures (54.5%), irrigated-tip catheter &amp;ndash; in 814 (59.5%), cryoballoon catheter &amp;ndash; in 130 (9.5%), and intracardiac echocardiography &amp;ndash; in 33 (2.4%). The most frequently performed ablation was pulmonary vein isolation (40.2%), followed by ablation for AV nodal reentrant tachycardia (18.6%) and typical atrial fl utter (16.6%). The acute success was over 98%, while intraprocedural complications were less than 2%. Conclusion: The national registry of electrophysiology collects systematically and continuously basic data on all ablations of cardiac arrhythmias performed in the country. In 2022, during a subsiding COVID-19 pandemic and with the inclusion of new centers the number of ablations increased compared to 2021. Distribution of EP procedure types was similar to previous years. Acute success was very high, while intraprocedural complications were rare.

PO-04-147 LEADLESS PACING IN ADULT CONGENITAL HEART DISEASE PATIENTS: MULTI-CENTRE UK EXPERIENCE

A significant number of Adults with Congenital Heart Disease (ACHD) require cardiac rhythm management devices. Implantation of endocardial or epicardial pacemakers presents specific challenges in this population. The Micra leadless pacemakers have potential to overcome some of these challenges. To assess the utility of Micra implant in ACHD population. A retrospective analyses of Micra implants undertaken at Barts Heart Centre, London and Liverpool Heart and Chest Hospital in the ACHD population between 2020-2022. Data was collected from a prospective registry and electronic health records. Patients were contacted for follow-up data where necessary. 26 AV Micras were implanted across the two centres over two years. 52% females with mean age of 37 yrs. 42% were anticoagulated with warfarin or a DOAC. Underlying etiology – Figure 1. Micra indication – Table 1. Mean procedure and fluoroscopy times were 57±21min and 7±1 min. Access site was femoral in 77% and transjugular in 23%. Mean sensing and thresholds were 11±0.4mV and 0.6±0.09V at 0.24ms respectively. There were no acute procedural complications. Over a mean follow-up of 13 months there were no significant programming issues or change in pacing parameters. One patient had high thresholds and one died of non-cardiac causes. Micra implants should be considered in cases where endocardial or epicardial implants are contraindicated or represent an otherwise suboptimal approach. They have advantages in ACHD patients with complex cardiac anatomy, difficult venous access and need for repeat procedures. Larger multicentre studies and longer follow-ups are required.Tabled 1Table 1Micra Indicationn, %Failed endocardial system6,23Failed epicardial system6,23Bridge to CRTP3,12SVC occlusion3,12Other8,30 Open table in a new tab

PO-03-029 LEFT BUNDLE BRANCH AREA PACING LEARNING CURVE AND OUTCOMES IN A BEGINNER IMPLANTER

Left bundle branch area pacing (LBBAP) is a rapidly growing conduction system pacing technique. However, little is known about the learning curve of LBBAP implants in a beginner implanter. We sought to determine acute procedural success rate, implant characteristics, and complications of a single operator implanting LBBA pacing devices in his first year of unsupervised practice. All patients who underwent pacemaker and CRT device implants at our center by a single operator (TC) were reviewed. LBBAP was defined as the presence of R’ in lead V1, and LV activation time (LVAT) <= 80 msec (stim to peak in V6) in the paced QRS complex. Charts were retrospectively reviewed to determine rates of LBBA capture, procedure duration, fluoroscopy time, lead dislodgement, and lead revision rates. LBBA pacing was attempted in 80 patients. Medtronic C315 sheath was used to deliver a Medtronic 3830 lead to the LBBA in all cases. LBBA capture was obtained in 69/80 (86%) patients. Mean paced QRS duration was 131 +/- 13 msec. and mean LVAT was 66 +/- 11 msec. For the first 20 implants, mean procedure duration was 104 +/-32 minutes, and mean fluoroscopy time was 11 +/- 6 minutes. Subsequent 60 implants had significantly lower mean procedure duration (82 +/- 21 mins, p < 0.01) and fluoroscopy time (8 +/- 4 mins, p = 0.01). Overall, mean procedure duration was 88 +/- 26 minutes, and mean fluoroscopy time was 9 +/- 5 minutes. Rate of LBBA capture increased from 70% for the first 20 implants to 92% for the last 60 implants. No significant differences were observed in QRS duration and LVAT time between the first 20 and last 60 implants. Three lead dislodgements occurred, all of which occurred prior to the 15th procedure. One patient required lead revision for increasing pacing thresholds. In this single center, retrospective study of a single operator in his first year of unsupervised practice, LBBA pacing was achieved in majority of patients. Rate of lead dislodgement and need for lead revision were low. Procedural success rate increased while procedure duration, fluoroscopy use, and complications decreased after 20 implants.

PO-04-042 GENDER DIFFERENCES IN CLINICAL OUTCOMES AFTER PULSED FIELD ABLATION OF ATRIAL FIBRILLATION: INTERIM ANALYSIS OF THE MANIFEST-PF EFFICACY REGISTRY

Prior studies have shown that atrial fibrillation (AF) ablation with conventional thermal ablative modalities, radiofrequency (RF) or cryo, is associated with a higher risk of complications in women compared with men, and a lower success rate of freedom from AF recurrences. Pulsed-field ablation (PFA) is a novel AF ablation energy modality which, in first-in-human clinical trials, has demonstrated preferential myocardial tissue ablation with a unique safety profile. We performed an interim analysis of the MANIFEST-PF registry to explore gender differences in real-world outcomes after PFA of AF. MANIFEST-PF is a retrospective patient-level registry from the first 23 European centers performing clinical PFA procedures, including all consecutive patients who received first-ever ablation for paroxysmal or persistent AF between March to December 2021 using the pentaspline PFA catheter (Farawave, Farapulse-Boston Scientific Inc). We compared baseline and procedural characteristics, and clinical outcomes between men and women. The efficacy endpoint was freedom from atrial arrhythmia (AF/atrial flutter/atrial tachycardia) recurrence ≥30 seconds after a 3 month-blanking period. Safety endpoints included major/minor adverse events (AEs <7 days post-procedure). Binary logistic regression model was created using -- Age, CAD, CHF, Sleep apnea, LVEF, LAD, Non-parox AF, Female, diabetes, HTN and stroke/TIA. Of the 1,332 AF pts who underwent an AF ablation, 454 (34%) were female. Woman, compared to men, were older (67±10 vs 62±11 yrs) and had more paroxysmal AF (72% vs 61%), but less comorbidities such as coronary disease, heart failure and sleep apnea. (Figure A) Following ablation, there was no significant difference in major (2.6% vs 1.1%, p=0.14) or minor (3.3% vs 4.4%, p=0.18) AEs between groups. Multivariable analysis showed that women (Odds ratio 4.1, 95% CI [1.21–13.78], p=0.02) were more likely to have a higher risk of acute major AEs. After a mean follow-up of 196 days, there was no difference in recurrence of atrial arrhythmia (14.5% vs 18%, p=0.14) or redo-ablations (5.1% vs. 7.7%, p=0.07) between women and men, respectively, even after adjusting for the type of AF (ie, PAF vs PerAF). (Figure B) As compared with men, women undergoing PFA to treat AF experience more acute major procedural complications, though the overall rate of complications was low with PFA. On the other hand, women have a similar success rate of freedom from recurrent atrial arrhythmias.

Temporal Trends in In-Hospital Outcomes Following Unprotected Left-Main Percutaneous Coronary Intervention: An Analysis of 14 522 Cases From British Cardiovascular Intervention Society Database 2009 to 2017

Percutaneous coronary intervention (PCI) is increasingly used as a treatment option for unprotected left main stem artery (unprotected left main stem percutaneous intervention) disease. However, whether patient outcomes have improved over time is uncertain. Using the United Kingdom national PCI database, we studied all patients undergoing unprotected left main stem percutaneous intervention between 2009 and 2017. We excluded patients who presented with ST-segment-elevation, cardiogenic shock, and with an emergency indication for PCI. Between 2009 and 2017, in the study-indicated population, 14 522 unprotected left main stem percutaneous intervention procedures were performed. Significant temporal changes in baseline demographics were observed with increasing patient age and comorbid burden. Procedural complexity increased over time, with the number of vessels treated, bifurcation PCI, number of stents used, and use of intravascular imaging and rotational atherectomy increased significantly through the study period. After adjustment for baseline differences, there were significant temporal reductions in the occurrence of peri-procedural myocardial infarction (P<0.001 for trend), in-hospital major adverse cardiac or cerebrovascular events (P<0.001 for trend), and acute procedural complications (P<0.001 for trend). In multivariable analysis examining the associates of in-hospital major adverse cardiac or cerebrovascular events, while age per year (odds ratio, 1.02 [95% CIs, 1.01-1.03]), female sex (odds ratio, 1.47 [1.19-1.82]), 3 or more stents (odds ratio, 1.67 [05% [1.02-2.67]), and patient comorbidity were associated with higher rates of in-hospital major adverse cardiac or cerebrovascular events, by contrast use of intravascular imaging (odds ratio, 0.56 [0.45-0.70]), and year of PCI (odds ratio, 0.63 [0.46-0.87]) were associated with lower rates of in-hospital major adverse cardiac or cerebrovascular events. Despite trends for increased patient and procedural complexity, in-hospital patient outcomes have improved after unprotected left main stem percutaneous intervention over time.

Interventional electrophysiology in Bulgaria in 2021: data from the electronic registry BG-EPHY

This study presents data from the national electronic registry BG-EPHY on electrophysiologic (EP) cardiac ablations in 2021. Material and methods: This is a retrospective study of a full one-year sample of the BG-EPHY registry. Sex and age distribution of the patients, number of ablations, electroanatomic mapping (EAM), irrigated and cryoablations, distribution of different types of arrhythmias, acute procedural success and complications are presented. Results: In 2021 fi ve EP centers performed 872 ablations in 546 men (62.6%) and 326 women (4.4% increase compared to previous year), incl. 6 ablations in pediatric patients (0.7%). EAM was used in 60.9% of the procedures, irrigation catheter was used in 55.2%, cryoballoon catheter &amp;ndash; in 6%, and intracardiac echocardiography &amp;ndash; in 4.2%. The most common ablation was pulmonary vein isolation, followed by ablation for AV nodal reentrant tachycardia and typical atrial fl utter. The acute success was over 98%, while intraprocedural complications were less than 2%. Conclusion: The national registry of electrophysiology collects systematically and continuously basic data on all ablations of cardiac arrhythmias performed in the country. In 2021, during a continuing COVID-19 pandemic the number of ablations increased slightly compared to the previous year. Distribution of EP procedure types was similar to previous years. Acute success was very high, while intraprocedural complications were rare.

Short term outcomes of distal (ventricular) His bundle pacing: A single centre retrospective study

Abstract Funding Acknowledgements Type of funding sources: None. Introduction Chronic right ventricular apical pacing can lead to pacing induced cardiomyopathy in a significant proportion of patients. Conduction system pacing may restore more physiological activation of the heart, and has recently been shown to have favourable outcomes in clinical trials. However there remains concern regarding the long-term outcomes due to lead displacement and high pacing thresholds. The most widely used technique in current practice is to pace the His bundle proximal to the tricuspid valve. Distal His bundle pacing has a number of advantages over proximal His pacing, including, lower capture thresholds, a more stable lead position, less far field atrial sensing and better spacing from the AV node in case ablation of this is required for AF rate control. Despite these, outcomes of distal His bundle pacing from the ventricular aspect are less well defined. Methods We performed a retrospective review of patients who underwent conduction system pacing between January 2020 and October 2021 at our centre. During this period all procedures were performed employing a distal His bundle pacing approach with the lead placed on the ventricular aspect of the tricuspid annulus. Data was collected at implant, follow-up at 1 month and then every 6 months. Results Out of 35 patients, 33 underwent successful His bundle pacing (acute success rate of 94%), 1 patient had left bundle branch pacing and another patient had an unsuccessful procedure. Mean age was 74 years, median LVEF 45% and median pre-implant QRS was 108ms. 80% of the cohort had a history of AF. The indications for pacing were as follows: AF - for pace &amp; ablate (60%); high grade AV block with narrow QRS and mild LVSD (17%); failed LV lead (14%); and other 9%. Mean procedure duration and fluoroscopy time were 78 minutes and 12.05 minutes, respectively. Median threshold at implant was 1.00V (IQR 0.719V). Selective His bundle pacing was achieved in 60% and non-selective in 34%. Mean follow-up duration was 150 days with median threshold at last f/up of 0.75V (IQR 0.750V). There were no acute procedural complications. 1 patient had a significant rise in threshold at follow-up and therefore required upgrade to CRT-P. Discussion Our data shows that distal His bundle pacing is a safe and effective technique for conduction system pacing. Thresholds appear stable at follow-up and failure rate was found to be comparable to biventricular pacing. We noted an initial learning curve for both implanter and physiologists with relatively poorer outcomes for the earlier cases. Longer term follow-up is ongoing, including functional assessment and follow-up to assess for remodelling with echocardiography. Prospective randomised trials are needed to compare conduction system pacing vs RV pacing in AF patients with HFpEF or mild LVSD undergoing AVN ablation, and vs biventricular pacing in the severe LVSD population.

Short term outcome of distal (ventricular) His bundle pacing and atrioventricular node ablation in patients with symptomatic atrial fibrillation - Refining the concept

Abstract Funding Acknowledgements Type of funding sources: None. Introduction Many patients with atrial fibrillation (AF) do not benefit from rhythm control due to failed catheter ablation, advanced left atrial disease and comorbidities. "Pace and AV node (AVN) ablation" strategy is often adopted for rate control but with a substantial risk of pacing-induced cardiomyopathy. His bundle pacing (HBP) enables physiological biventricular activation through the His Purkinje conduction system. However, the proximity of the HBP lead to the site of AV node ablation may potentially compromise lead integrity in patients who undergo conventional HBP and AVN ablation. Therefore, we have modified HBP by placing the HBP lead distally at the ventricular side of the His bundle (D-HBP) before AVN ablation in patients with symptomatic AF. All patients had a backup RV lead. Method Patients who had D-HBP as part of a "Pace and AVN ablation" strategy were retrospectively analysed. Implant and device clinic follow-up data were collected and analysed. Result Twenty-one patients who had "pace and AVN ablation strategy" with D-HBP between 26th February 2020 and 3rd November 2021 were included. They had a mean age of 75 ± 1.4 years (mean ± SEM), NYHA class of 2.1 ± 0.2, QRS duration of 106 ± 5.3ms and 50% had at least moderately impaired LV systolic function. Seventeen patients (81%) had narrow QRS duration. D-HBP was successful in twenty of twenty-one patients (95%). At D-HBP implant, the mean acute threshold of the HBP lead was 0.96 ± 0.12V at 0.5 ± 0.05ms and the mean HBP lead impedance was 548.1 ± 29.5Ω. Selective HBP pacing was observed in thirteen of twenty patients. The mean QRS duration of HBP paced beats was 104.5 ± 4.7ms. Failure to capture the His bundle was observed in one patient. AVN ablation was performed on the same day after D-HBP in eleven patients and as a subsequent procedure in nine patients. The mean duration of procedure and fluoroscopy for D-HBP were 77.4 ± 4.6 minutes and 11.9 ± 1.4 minutes respectively. There were no acute procedural complications with no lead damage, displacement or lead perforation observed. The median follow-up period was 207 days. The mean D-HBP lead threshold following AVN ablation was 1.1 ± 0.2 V at 0.6 ± 0.07 ms and the mean lead impedance was 433.8 ± 20.7Ω, which were similar to before AVN ablation. One patient was reprogrammed with RV pacing only for elevated HBP lead threshold after AVN ablation to 4.2 V at 1ms. The mean D-HBP percentage was 92.3 ± 6.6% and the mean estimated battery longevity of the pacemaker was 7.9 ± 0.6 years at the last follow up. There was improvement in heart failure symptoms in eight patients from previously symptomatic to NYHA class I following D-HBP and AVN ablation. Conclusion D-HBP appear to be safe with potentially more favourable lead parameters than conventional proximal HBP in patients with symptomatic AF offered "Pace and AVN ablation" strategy.

Multipolar pulsed-field ablation for the treatment of left atrial reentry tachycardia

Abstract Funding Acknowledgements Type of funding sources: None. Background A multipolar pulsed field ablation (PFA) catheter was recently introduced for pulmonary vein isolation and combines the benefits of high procedural efficacy and safety. It may also be used to treat left atrial (LA) reentry tachycardia. Purpose To describe our initial experience using a multipolar PFA catheter for the treatment of LA reentry tachycardia. Methods We included all patients with LA reentry tachycardia treated with a multipolar PFA catheter at our institution. Using 3D electro-anatomical mapping (3D-EAM), we identified the tachycardia mechanism and applied linear lesions either at the left atrial roof, mitral isthmus or on the anterior wall, as appropriate. Positioning of the PFA catheter was verified by integration into 3D-EAM. Applications were performed using 2.0kV with the catheter in basket or flower configuration, depending on ablation site. Bidirectional block across linear lesions was verified using standard criteria. Additional focal radiofrequency ablation (RFA) was used to achieve bidirectional block if necessary. Results We treated 17 LA reentry tachycardia with a multipolar PFA catheter in 13 patients (median age 69 (59-73) years; 5 females). The tachycardia mechanism was identified as roof-dependent in five, peri-mitral in eight and anterior scar-related in four cases. PFA lesion sets consisted of 12 posterior wall isolations (i.e. roof lines), four mitral isthmus lines (MIL) and eight anterior lines. For ablation of the mitral side of the anterior line, we always used the PFA catheter in basket configuration, while we targeted the posterior wall and the superior side of the anterior line exclusively with the catheter in flower configuration. To ablate the MIL we used both flower and basket configurations. Three roof-dependent, six peri-mitral, and four anterior scar-related tachycardias were successfully terminated by PFA (76%). Additional RFA was necessary for two MIL, two anterior lines and no roof line (17%). Finally, we achieved bidirectional block across all lines. PFA triggered, vagal-mediated and reversible AV block was observed in one case. Otherwise, there were no acute procedural complications. Conclusion Linear lesion sets are feasible and safe using a multipolar PFA catheter. Posterior wall isolation by PFA for the treatment of roof-dependent LA reentry tachycardia is highly efficient while anterior lines and MIL remain challenging and may need complementary RFA or a PFA catheter designed for focal or linear ablations.

Impact of sex on clinical, procedural characteristics and outcomes of catheter ablation for ventricular arrhythmias according to underlying heart disease.

Women are under-represented in many key studies and trials examining outcomes of catheter ablation (CA) for ventricular arrhythmias (VA). We compared characteristics between men and women undergoing their first catheter ablation for VA at a single centre over 10years. The clinical, procedural characteristics and outcomes of 287 consecutive patients (male = 182, female = 105), undergoing their first CA at our centre over 10years were compared according to sex and underlying heart disease. In the ablation population, women were younger, had fewer co-morbidities, were less likely to have ischemic cardiomyopathy (ICM) and VA storm and were more likely to have idiopathic VA and premature ventricular complexes as the indication for ablation (P < 0.05 for all). Amongst idiopathic and non-ischemic cardiomyopathy (NICM) subgroups, baseline characteristics were similar; amongst ICM, women were younger and had higher numbers of drug failure pre-ablation (P = 0.05). Women were similar to men in all procedural characteristics, acute procedural success and complications, regardless of underlying heart disease. At median follow-up of 666days, VA-free survival, overall mortality and survival free of death or transplant were comparable in both groups. Sex was not a predictor of these outcomes, after accounting for clinical and procedural characteristics. Women represented 36% of the real-world population at our centre referred for CA of VA. There are key differences in clinical features of women versus men referred for VA ablation. Despite these differences, VA ablation in women can be accomplished with similar success and complication rates to men, regardless of underlying heart disease.

Acute procedural outcomes of his bundle pacing with or without electrophysiology mapping system: a multicenter study

Abstract Funding Acknowledgements Type of funding sources: None. Introduction His bundle pacing (HBP) is associated with improved clinical outcomes compared to right ventricular apical pacing. However, it can be technically challenging and may result in prolonged fluoroscopy and procedural time. Purpose We sought to compare the feasibility of performing HBP with or without electrophysiology mapping (EP) system, focusing on evaluating acute procedural success, complication rates and short-term outcomes. Methods HBP patients at 3 hospitals were recruited between August 2018 to December 2020. HBP was performed with EP mapping system in 1 center, and without EP mapping in the other 2 centers. Acute procedural success was defined as either selective or non-selective His bundle capture with a threshold of less than or equal to 1.5V at 1ms at the end of procedure implantation. Results A total of 233 patients were recruited, of which HBP was performed with EP mapping in 77 patients (33.0%) and without EP mapping in 156 patients (67.0%). Both groups were similar in age (73.2 ± 11.0 years vs 75.3 ± 9.5 years, p = 0.125) and male sex (58.4% vs 48.1%, p = 0.136). There were more patients with ischemic heart disease (45.5% vs 22.4%, p &amp;lt; 0.01) and reduced left ventricular ejection fraction ≤ 40% (28.6% vs 10.9%, p &amp;lt; 0.01) in the group with EP mapping. The indications for HBP was for high-grade atrioventricular block (55.8%), sick sinus syndrome (35.6%) and cardiac resynchronization therapy (CRT) (8.6%). There were more patients who required CRT in the center with EP mapping (18.2% vs 3.8%, p &amp;lt; 0.01). HBP was successful in 39 patients (50.6%) with EP mapping and 93 patients (59.6%) without EP mapping (p= 0.382). The median R wave at implant was similar in both groups [4.0 (2.9 – 6.2) mV vs 4.3 (4.3 – 7.0) mV, p = 0.808]. Impedance at implant (607 ± 195 ohms vs 547 ± 166 ohms, p &amp;lt; 0.01) and selective His bundle bipolar threshold at implant [1.25 (0.75-1.75) V vs 0.7 (0.5 – 1.25) V, p = 0.01] was higher in patients with EP mapping while non-selective His bundle bipolar threshold at implant [1.75 (1.0 – 3.0) V vs 1.5 (0.9 – 2.2) V, p = 0.133] and paced QRS duration (116.4 ± 25.4 ms vs 114.4 ± 24.2 ms, p =0.655) were similar. There were no differences in procedural or fluoroscopy time between groups (111 ± 36.9 min vs 107 ± 40.7 min, p = 0.479; and 10.3 ± 8.9 min vs 12.1± 14.0 min, p = 0.328 respectively). There was a similar rate of acute procedural complications (5.2% vs 1.3%, p = 0.076) and patients requiring wound or lead revision (6.8% vs 1.9%, p = 0.115) after a median follow up duration of 205 days (67-397). The prevalence of new onset paroxysmal atrial fibrillation (11.7% vs 4.2%, p = 0.037) and all cause mortality (12.3% vs 3.2%, p = 0.029) was increased in patients who underwent HBP with EP mapping. Conclusion HBP in centers with or without EP mapping showed similar acute procedure success and complication rates. The use of EP mapping system was not shown to affect procedural or fluoroscopy duration.

Effectiveness and safety of one-stop procedure versus ablation alone in patients with non-valvular atrial fibrillation: a meta-analysis

Background: Catheter ablation (CA) and left atrial appendage closure (LAAC) are two effective treatments for atrial fibrillation. Furthermore, atrial fibrillation (AF) ablation combined with left atrial occlusion closure (LAAC) is a potential therapy option for AF in individuals who are at high risk of stroke or who are unable to take oral anticoagulants. This study intends to analyze and evaluate the difference in effectiveness and safety between one-stop operation, in which patients accept AF ablation and LAAC in one surgery, and ablation alone in patients with non-valvular AF through the method of meta-analysis. Methods: This study searches PubMed, Embase, Medline, the Cochrane Library, CNKI, VIP Database, and WANFANG Database for clinical studies of combined therapy and AF ablation in the prevention of AF, combining subject words with free words, and the retrieval time is from the establishment of each database to September 29, 2021. Results: The meta-analysis comprised five clinical studies with a total of 488 patients with AF who received AF ablation alone and 269 patients who received ablation and LAAC in one stop. Patients with paroxysmal AF, persistent AF, long-standing persistent AF, or all of these conditions were included in all of the investigations. At long-term follow-up, the rate of AF recurrence was not substantially different between the two groups (one-stop procedure 39.03 % vs. AF ablation 28.28 %, respectively; OR 1.34; 95% CI 0.95-1.87; P = 0.32). Furthermore, there was no statistically significant difference in terms of major complications and adverse events between the two groups (one-stop procedure 13.75 % vs. AF ablation 13.73 %, respectively; OR 0.73; 95% CI 0.44-1.18; P = 0.54). Conclusion: Using LAAC in addition to CA had no effect on the efficacy of AF ablation, and the combination method was performed without an increased risk of acute procedural complications or negative effects.

A Warm Welcome to The First Issue of JSCAI

A Warm Welcome to The First Issue of JSCAI

Device profile of the FLEX Vessel Prep System for the treatment of peripheral arterial disease: overview of its safety and efficacy

ABSTRACT Introduction The standard endovascular treatment for obstructed peripheral arterial disease (PAD) lesions and stenosed arteriovenous (AV) fistulae is percutaneous transluminal angioplasty (PTA). Despite consistent effectiveness in restoring blood flow, PTA does introduce risk of uncontrolled dissections that require stenting. The FLEX Vessel Prep™ System (FLEX VP) is a novel, dynamic, self-sizing, nonballoon device designed to modify obstructive stenoses and plaque, improve vessel compliance and facilitate delivery of drug therapies by creating longitudinal, controlled-depth, circumferential microincisions along the entire length of a lesion. Areas covered In this profile, the mechanism of action of the FLEX VP system is described and differentiated. Acute procedural complications and long-term clinical outcomes following FLEX VP+PTA are presented. Specifically, the unmet clinical need for safe and effective vessel preparation in long, complex, mixed morphology PAD lesions is highlighted. Expert opinion The FLEX VP system is an innovative approach to create predictable and consistent longitudinal microincisions in long lesions that improve acute luminal gain and vessel compliance by releasing circumferential tension in the lesion. This nonballoon-based device for plaque modification is safe, effective, easy-to-use, and minimizes PTA-associated dissections, therefore reducing stenting, supporting the ‘leave nothing behind’ incentive of physicians, and improving long-term clinical outcomes with less vessel trauma.

Fluoroscopy-free ablation in congenital heart disease of moderate or great complexity.

Fluoroscopy-free (FF) ablation has been demonstrated to be safe and successful in patients with structurally normal hearts, but has not been systematically evaluated in patients with congenital heart disease (CHD) of moderate or great (M/G) complexity. This study aimed to evaluate and compare feasibility, safety, and outcomes of FF ablation in patients with or without M/G-CHD. Consecutive patients undergoing electrophysiologic study and intended catheter ablation over a 24-month period were included. Subgroups were created based on presence and complexity of CHD-M/G-CHD or simple complexity/no CHD (S/N-CHD). Cases with total radiation dose of zero qualified as FF. Demographic and peri-procedural variables and outcome data were analyzed. A total of 89 procedures were included with 62 comprising the S/N-CHD group and 27 comprising the M/G-CHD group. Of the M/G-CHD patients, 13 had CHD of great complexity (including 6 single ventricle/Fontan and 2 atrial switch patients). Patients with M/G-CHD were older, had higher BMI, had higher incidence of ventricular dysfunction, and greater incidence of complex arrhythmias. Fluoroscopy-free ablation was achieved in 59% of M/G-CHD and 69% of S/N-CHD patients. Both groups had similar rates of acute procedural success, recurrence, and complications. Fluoroscopy was primarily used to visualize pre-existing transvenous leads and peripheral venous anomalies or to guide transbaffle/transseptal puncture. A fluoroscopy-free ablation approach is feasible, safe, and successful even in patients with M/G-CHD with comparable outcomes to those with S/N-CHD.