Redo procedures after sinus node sparing hybrid ablation for inappropriate sinus tachycardia/postural orthostatic sinus tachycardia.

AIMS: A novel sinus node (SN) sparing hybrid ablation for inappropriate sinus node tachycardia (IST)/postural orthostatic tachycardia syndrome (POTS) has been demonstrated to be an effective and safe therapeutic option in patients with symptomatic drug-resistant IST/POTS. The aim of this study was to evaluate the long-term rate of redo procedures after hybrid IST ablation and procedural strategy, outcomes and safety of redo procedures. METHODS AND RESULTS: All consecutive patients from 2015 to 2023 were prospectively enrolled in the UZ Brussel monocentric IST/POTS registry. They were analysed if the following inclusion criteria were fulfilled: 1) diagnosis of IST or POTS, 2) symptomatic IST/POTS refractory or intolerant to drugs, and 3) hybrid SN sparing ablation performed. The primary endpoint was redo procedure. The primary safety endpoint was pacemaker (PM) implantation. A total of 220 patients undergone to hybrid IST ablation were included, 185 patients (84.1%) were treated for IST and 61 patients (27.7%) for POTS.After a follow-up of 73.3 ± 16.2 months, 34 patients (15.4%) underwent a redo. A total of 23 patients (67.6%) had a redo for IST recurrence and 11 patients (32.4%) for other arrhythmias. Pacemaker implantation was performed in 21 patients (9.5%). Nine patients (4.1%) had no redo procedure and experienced sick sinus syndrome requiring a PM. Twelve patients (5.4%) received a PM as a shared therapeutic choice combined with SN ablation procedure. CONCLUSION: In a large cohort of patients the long-term free survival from redo procedure after hybrid IST ablation was 84.6% with a low PM implantation rate.

Safety and efficacy of zero fluoroscopy transseptal puncture with different approaches.

INTRODUCTION: Atrial fibrillation (AF) ablation requires access to the left atrium (LA) via transseptal puncture (TP). TP is traditionally performed with fluoroscopic guidance. Use of intracardiac echocardiography (ICE) and three-dimensional mapping allows for zero fluoroscopy TP. OBJECTIVE: To demonstrate safety and efficacy of zero fluoroscopy TP using multiple procedural approaches. METHODS: Patients undergoing AF ablation between January 2015 and November 2017 at five institutions were included. ICE and three-dimensional mapping were used for sheath positioning and TP. Variable technical approaches were used across centers including placement of J wire in the superior vena cava with ICE guidance followed by dragging down the transseptal sheath into the interatrial septum, or guiding the transseptal sheath directly to the interatrial septum by localizing the ablation catheter with three-dimensional mapping and replacing it with the transseptal needle once in position. In patients with pacemaker/implantable cardiac defibrillator leads, pre-/poststudy device interrogation was performed. RESULTS: A total of 747 TPs were performed (646 patients, age 63.1 ± 13.1, 67.5% male, LA volume index 34.5 ± 15.8 mL/m2 , ejection fraction 57.7 ± 10.9%) with 100% success. No punctures required fluoroscopy. Two pericardial effusions, two pericardial tamponades requiring pericardiocentesis, and one transient ischemic attack were observed during the overall ablation procedure, with a total complication rate of 0.7%. There were no other periprocedural complications related to TP, including intrathoracic bleeding, stroke, or death both immediately following TP and within 30 days of the procedure. In patients with intracardiac devices, no device-related complications were observed. CONCLUSION: TP can be safely and effectively performed without the need for fluoroscopy.

Pericarditis prophylactic therapy after sinus node-sparing hybrid ablation for inappropriate sinus tachycardia/postural orthostatic sinus tachycardia.

Background: Pericarditis is the most common complication following hybrid sinus node-sparing ablation for inappropriate sinus tachycardia (IST)/postural orthostatic tachycardia syndrome (POTS). Objective: The study sought to evaluate the association of prophylaxis therapy on the risk of symptomatic pericarditis following hybrid IST/POTS ablation. Methods: All consecutive patients undergoing to hybrid ablation of symptomatic IST/POTS refractory or intolerant to drugs were retrospectively analyzed. Pharmacological prophylaxis therapy was based on acetylsalicylic acid and colchicine started on the day of the ablation and continued for at least 3 months. The primary endpoint was occurrence of symptomatic pericarditis. The secondary endpoint was occurrence of pericarditis-related complications, including the following: duration of pericarditis >3 months, hospitalization for pericarditis, postpericardiectomy pleuro-pericarditis, and pericardiectomy. Results: A total of 220 patients undergone to hybrid IST/POTS ablation were included and 44 (20%) underwent prophylaxis therapy. Pericarditis occurred in 101 (45.9%) patients, with 97 (96%) in the first 5 days. At survival analysis, prophylaxis was associated with higher rate of freedom from pericarditis (81.9% vs 47.2%, log-rank P < .001). Pericarditis-related complications were low, occurring in 7 (3.2%) patients. There was no difference in pericarditis-related complications between the patients who underwent prophylaxis therapy and patients who did not. At Cox multivariate analysis, predictors of pericarditis were IST (vs POTS) (hazard ratio 0.61, 95% confidence interval0.39-0.99, P = .04) and prophylaxis therapy (hazard ratio 0.27, 95% confidence interval 0.13-0.55, P < .001). Conclusion: In a large cohort of patients undergoing hybrid ablation for IST/POTS, a prophylaxis therapy with acetylsalicylic acid and colchicine was associated with a lower rate of symptomatic pericarditis.

Hybrid epicardial and endocardial sinus node-sparing ablation therapy for inappropriate sinus tachycardia: Rationale and design of the multicenter HEAL-IST IDE trial.

Background: Inappropriate sinus tachycardia (IST) is defined as resting heart rate >100 beats/min and average 24-hour heart rate >90 beats/min. It is associated with distressing symptoms and significant loss of quality of life. Drugs are not effective in symptom control of IST in up to 30% of patients. Catheter ablation of the sinus node has a high recurrence rate, and the complications are significant. Recently, a novel hybrid sinus node-sparing ablation approach for IST was described. Objective: The objective of the Hybrid Epicardial and Endocardial Sinus Node Sparing Ablation Therapy for Inappropriate Sinus Tachycardia (HEAL-IST) investigational device exemption trial (NCT05280093) is to evaluate safety and effectiveness of the hybrid sinus node-sparing ablation procedure for the treatment of symptomatic, drug-refractory or drug-intolerant IST. Methods: The HEAL-IST trial is a prospective, multicenter, pivotal, single-arm trial. Up to 142 subjects in up to 40 centers will be treated in the trial with a Bayesian adaptive design. Results: Subjects will be assessed for primary safety through 30 days post-hybrid ablation procedure. The primary effectiveness endpoint will be freedom from IST at 12 months. Freedom from IST will be defined as mean heart rate of ≤90 beats/min or at least a 15% reduction in mean heart rate as compared with baseline, in the absence of new or higher dosage of previously failed medications at a 24-month follow-up assessment. Conclusion: The HEAL-IST trial is the first multicenter trial evaluating hybrid IST ablation in patients with symptomatic IST and refractory or intolerant to drugs. The results of this study will help guide decision making regarding the best management in this population.

Targeted Treatment of Inappropriate Sinoatrial Node Tachycardia Based on Electrophysiological and Structural Mechanisms.

The purpose of this review is to determine the causal mechanisms and treatment of inappropriate sinoatrial tachycardia (IST), defined as a non-physiological elevation in resting heart rate. IST is defined as a resting daytime sinus rate >100 beats/minute and an average 24-hour heart rate >90 beats/minute. Potential causal mechanisms include sympathetic receptor hypersensitivity, blunted parasympathetic tone, or enhanced intrinsic automaticity within the sinoatrial node (SAN) pacemaker-conduction complex. These anomalies may coexist in the same patient. Recent ex-vivo near-infrared transmural optical imaging of the SAN in human and animal hearts provides important insights into the functional and molecular features of this complex structure. In particular, it reveals the existence of preferential sinoatrial conduction pathways that ensure robust SAN activation with electrical conduction. The mechanism of IST is debated because even high-resolution electroanatomical mapping approaches cannot reveal intramural conduction in the 3-dimensional SAN complex. It may be secondary to enhanced automaticity, intranodal re-entry, or sinoatrial conduction pathway re-entry. Different pharmacological approaches can target these mechanisms. Long-acting ß blockers in IST can act on both primarily increased automaticity and dysregulated autonomic system. Ivabradine targets sources of increased SAN automaticity. Conventional or hybrid ablation may target all the described abnormalities. This review provides a state-of-the-art overview of putative IST mechanisms. In conclusion, based on current knowledge, pharmacological and ablation approaches for IST, including the novel hybrid SAN sparing ablation, are discussed.

High-power, short-duration atrial fibrillation ablations using contact force sensing catheters: Outcomes and predictors of success including posterior wall isolation.

BACKGROUND: Little is known about the long-term outcomes and predictors of success of high-power, short-duration (HPSD) contact force (CF) atrial fibrillation (AF) ablations. OBJECTIVE: The purpose of this study was to determine long-term freedom from AF and predictors of freedom from AF for 50-W, 5- to 15-second CF ablation. METHODS: We examined 4-year outcomes and predictors of freedom from AF after AF ablation for 1250 consecutive patients undergoing HPSD CF ablations. RESULTS: Patient demographics were age 66.6 ± 10.5 years, female 30.9%, left atrial (LA) size 4.26 ± 0.66 cm, paroxysmal AF 35.7%, persistent AF 56.6%, and longstanding AF 7.7%. Initial ablation times were procedure 114.2 ± 45.9 minutes, fluoroscopy 15.5 ± 11.5 minutes, and total radiofrequency 20.6 ± 7.7 minutes. TactiCath was used in 47.7%, SmartTouch in 52.3%, and posterior wall isolation (PWI) was performed in 34%. Four-year freedom from AF after multiple ablations were paroxysmal AF 87.0%, persistent AF 71.9%, and longstanding AF 64.9%. Single procedure success was 74.9% for TactiCath, 64.7% for SmartTouch (P <.001), and 73.0% for no PWI vs 58.9% for PWI (P <.0001). PWI did not change outcomes for paroxysmal AF but had worse outcomes for nonparoxysmal AF. Multivariate analysis showed 6 independent predictors of worse outcome after initial ablation: older age (P = .014), female gender (P <.0001), persistent AF (P = .0001), larger LA size (P <.001), PWI (P = .049), and use of SmartTouch vs TactiCath catheter (P = .007). Redo ablations were performed in 13.8%, and the outcome was better when more veins had reconnected after the initial ablation and when AF was paroxysmal. CONCLUSION: Analysis revealed 6 independent predictors of outcome for HPSD CF. At redo ablations, the outcome was better if more veins had reconnected and could be re-isolated.

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

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

Minimizing Radiation in the Modern Electrophysiology Laboratory.

Historically, the electrophysiology laboratory has relied heavily on the use of ionizing radiation in the form of fluoroscopy for a broad range of interventions and diagnostics. As the harmful effects of radiation have become increasingly recognized and procedural technologies have advanced, electrophysiologists have adopted new workflows. The purpose of this article is to review the available literature and experience in minimizing radiation in the modern electrophysiology laboratory. This review first covers general approaches to reducing fluoroscopy radiation in the electrophysiology suite, with concepts that apply across all procedure types. These include the reduction of infrared emission through fastidious fluoroscopy settings, new and proven solutions for radiation shielding, and methods of creating distance between the radiation source and the operator to reduce exposure. Following this discussion, we review specific task-based techniques for reducing radiation during special electrophysiologic procedures and workflows such as vascular access, coronary sinus lead placement, catheter manipulation, and periprocedural planning studies.

Effects of Transendocardial Stem Cell Injection on Ventricular Proarrhythmia in Patients with Ischemic Cardiomyopathy: Results from the POSEIDON and TAC-HFT Trials.

Transendocardial stem cell injection in patients with ischemic cardiomyopathy (ICM) improves left ventricular function and structure but has ill-defined effects on ventricular arrhythmias. We hypothesized that mesenchymal stem cell (MSC) implantation is not proarrhythmic. Post hoc analyses were performed on ambulatory ECGs collected from the POSEIDON and TAC-HFT trials. Eighty-eight subjects (mean age 61 ± 10 years) with ICM (mean EF 32.2% ± 9.8%) received treatment with MSC (n = 48), Placebo (n = 21), or bone marrow mononuclear cells (BMC) (n = 19). Heart rate variability (HRV) and ventricular ectopy (VE) were evaluated over 12 months. VE did not change in any group following MSC implantation. However, in patients with ≥ 1 VE run (defined as ≥ 3 consecutive premature ventricular complexes in 24 hours) at baseline, there was a decrease in VE runs at 12 months in the MSC group (p = .01), but not in the placebo group (p = .07; intergroup comparison: p = .18). In a subset of the MSC group, HRV measures of standard deviation of normal intervals was 75 ± 30 msec at baseline and increased to 87 ± 32 msec (p =.02) at 12 months, and root mean square of intervals between successive complexes was 36 ± 30 msec and increased to 58.2 ± 50 msec (p = .01) at 12 months. In patients receiving MSCs, there was no evidence for ventricular proarrhythmia, manifested by sustained or nonsustained ventricular ectopy or worsened HRV. Signals of improvement in ventricular arrhythmias and HRV in the MSC group suggest a need for further studies of the antiarrhythmic potential of MSCs. Stem Cells Translational Medicine 2017;6:1366-1372.