Initial clinical experience with the balloon-in-basket pulsed field ablation system: acute results of the VOLT CE mark feasibility study.

AIMS: Pulsed field ablation (PFA) for the treatment of atrial fibrillation (AF) potentially offers improved safety and procedural efficiencies compared with thermal ablation. Opportunities remain to improve effective circumferential lesion delivery, safety, and workflow of first-generation PFA systems. In this study, we aim to evaluate the initial clinical experience with a balloon-in-basket, 3D integrated PFA system with a purpose-built form factor for pulmonary vein (PV) isolation. METHODS AND RESULTS: The VOLT CE Mark Study is a pre-market, prospective, multi-centre, single-arm study to evaluate the safety and effectiveness of the Volt™ PFA system for the treatment of paroxysmal (PAF) or persistent AF (PersAF). Feasibility sub-study subjects underwent phrenic nerve evaluation, endoscopy, chest computed tomography, and cerebral magnetic resonance imaging. Study endpoints were the rate of primary serious adverse event within 7 days and acute procedural effectiveness. A total of 32 subjects (age 61.6 ± 9.6 years, 65.6% male, 84.4% PAF) were enrolled and treated in the feasibility sub-study and completed a 30-day follow-up. Acute effectiveness was achieved in 99.2% (127/128) of treated PVs (96.9% of subjects, 31/32) with 23.8 ± 4.2 PFA applications/subject. Procedure, fluoroscopy, LA dwell, and transpired ablation times were 124.6 ± 28.1, 19.8 ± 8.9, 53.0 ± 21.0, and 48.0 ± 19.9 min, respectively. Systematic assessments of initial safety revealed no phrenic nerve injury, pulmonary vein stenosis, or oesophageal lesions causally related to the PFA system and three subjects with silent cerebral lesions (9.4%). There were no primary serious adverse events. CONCLUSION: The initial clinical use of the Volt PFA System demonstrates acute safety and effectiveness in the treatment of symptomatic, drug refractory AF.

2023 Cardiac Society of Australia and New Zealand Expert Position Statement on Catheter and Surgical Ablation for Atrial Fibrillation.

Catheter ablation for atrial fibrillation (AF) has increased exponentially in many developed countries, including Australia and New Zealand. This Expert Position Statement on Catheter and Surgical Ablation for Atrial Fibrillation from the Cardiac Society of Australia and New Zealand (CSANZ) recognises healthcare factors, expertise and expenditure relevant to the Australian and New Zealand healthcare environments including considerations of potential implications for First Nations Peoples. The statement is cognisant of international advice but tailored to local conditions and populations, and is intended to be used by electrophysiologists, cardiologists and general physicians across all disciplines caring for patients with AF. They are also intended to provide guidance to healthcare facilities seeking to establish or maintain catheter ablation for AF.

Alcohol Abstinence in Drinkers with Atrial Fibrillation.

BACKGROUND: Excessive alcohol consumption is associated with incident atrial fibrillation and adverse atrial remodeling; however, the effect of abstinence from alcohol on secondary prevention of atrial fibrillation is unclear. METHODS: We conducted a multicenter, prospective, open-label, randomized, controlled trial at six hospitals in Australia. Adults who consumed 10 or more standard drinks (with 1 standard drink containing approximately 12 g of pure alcohol) per week and who had paroxysmal or persistent atrial fibrillation in sinus rhythm at baseline were randomly assigned in a 1:1 ratio to either abstain from alcohol or continue their usual alcohol consumption. The two primary end points were freedom from recurrence of atrial fibrillation (after a 2-week "blanking period") and total atrial fibrillation burden (proportion of time in atrial fibrillation) during 6 months of follow-up. RESULTS: Of 140 patients who underwent randomization (85% men; mean [±SD] age, 62±9 years), 70 were assigned to the abstinence group and 70 to the control group. Patients in the abstinence group reduced their alcohol intake from 16.8±7.7 to 2.1±3.7 standard drinks per week (a reduction of 87.5%), and patients in the control group reduced their alcohol intake from 16.4±6.9 to 13.2±6.5 drinks per week (a reduction of 19.5%). After a 2-week blanking period, atrial fibrillation recurred in 37 of 70 patients (53%) in the abstinence group and in 51 of 70 patients (73%) in the control group. The abstinence group had a longer period before recurrence of atrial fibrillation than the control group (hazard ratio, 0.55; 95% confidence interval, 0.36 to 0.84; P = 0.005). The atrial fibrillation burden over 6 months of follow-up was significantly lower in the abstinence group than in the control group (median percentage of time in atrial fibrillation, 0.5% [interquartile range, 0.0 to 3.0] vs. 1.2% [interquartile range, 0.0 to 10.3]; P = 0.01). CONCLUSIONS: Abstinence from alcohol reduced arrhythmia recurrences in regular drinkers with atrial fibrillation. (Funded by the Government of Victoria Operational Infrastructure Support Program and others; Australian New Zealand Clinical Trials Registry number, ACTRN12616000256471.).

Hybrid Totally Thoracoscopic Maze and Catheter Ablation for Persistent Atrial Fibrillation: Initial Experience.

Atrial fibrillation is now a pandemic in our ageing community. Although James L. Cox devised a surgical procedure with near-universal curative success in 1987, catheter-based interventions have flourished. For persistent atrial fibrillation (AF), however, an isolated endocardial approach has limitations: procedural times are long, carry risk, and the outcomes are not durable. By combining left atrial endocardial and epicardial interventions with staged mapping, we optimise the benefits of both approaches. Our initial series of hybrid ablation for persistent atrial fibrillation reports excellent early outcomes, freedom from complications and excellent success at follow-up.

The extravascular implantable cardioverter-defibrillator: characterization of anatomical parameters impacting substernal implantation and defibrillation efficacy.

AIMS: The aim of this study is to provide a thorough, quantified assessment of the substernal space as the site of extravascular implantable cardioverter-defibrillator (ICD) lead placement using computed tomography (CT) scans and summarizing adverse events and defibrillation efficacy across anatomical findings. Subcutaneous ICDs are an alternative to transvenous defibrillators but have limitations related to ICD lead distance from the heart. An alternative extravascular system with substernal lead placement has the potential to provide defibrillation at lower energy and pacing therapies from a single device. METHODS AND RESULTS: A multi-centre, non-randomized, retrospective analysis of 45 patient CT scans quantitatively and qualitatively assessing bony, cardiac, vascular, and other organ structures from two human clinical studies with substernal lead placement. Univariate logistic regression was used to evaluate 15 anatomical parameters for impact on defibrillation outcome and adjusted for multiple comparisons. Adverse events were summarized. Substernal implantation was attempted or completed in 45 patients. Defibrillation testing was successful in 37 of 41 subjects (90%) using ≥10 J safety margin. There were two intra-procedural adverse events in one patient, including reaction to anaesthesia and an episode of transient atrial fibrillation during ventricular fibrillation induction. Anatomical factors associated with defibrillation failure included large rib cage width, myocardium extending very posteriorly, and a low heart position in the chest (P-values <0.05), though not significant adjusting for multiple comparisons. CONCLUSION: Retrospective analysis demonstrates the ability to implant within the substernal space with low intra-procedural adverse events and high defibrillation efficacy despite a wide range of anatomical variability.

Increased Incidence of Noise in the Tendril Pacemaker Lead Detected via Remote Monitoring.

BACKGROUND: Prior studies suggest increased rates of noise on the Tendril (St Jude Medical/Abbott, St. Paul, MN, USA) pacemaker lead. We aim to assess the incidence of lead noise in the Tendril and 5076 (Medtronic PLC, Minneapolis, MN, USA) pacemaker leads in our cohort and in the process assess the utility of remote monitoring for identifying lead malfunction. METHODS: Deidentified, multi-centre, prospectively collected observational cohort data was obtained to assess the incidence of noise on the Tendril and 5076 pacemaker leads. RESULTS: 148 Tendril and 737 CapSureFix Novus 5076 (Medtronic, MN, USA) pacemaker leads were remotely monitored. Incidence of noise on the Tendril was 8% and 0.27% on the CapSureFix Novus. CONCLUSION: Rates of noise in the Tendril lead are higher than a market competitor. Remote monitoring is useful in detecting this concerning anomaly.

Micra implantation in a patient with transposition of great arteries.

We describe a 56-year-old male with transposition of the great arteries and Mustard repair, superior vena cava obstruction, atrial fibrillation, and progressive deterioration of his epicardial lead performance. We were successful in deploying of Micra (Medtronic, Minneapolis, MN, USA) at the septo-apical area of his nonsystemic ventricle in a stable position with satisfactory pacing and sensing thresholds.

Long-term pacemaker dependency and impact of pacing on mortality following transcatheter aortic valve replacement with the LOTUS valve.

OBJECTIVES: To determine permanent pacemaker (PPM) dependency following transcatheter aortic valve replacement (TAVR) with the Lotus™ valve system (Boston Scientific), and the impact of PPM implantation on long-term morbidity and mortality. BACKGROUND: Conduction abnormalities are among the most common complications following TAVR. Limited studies have assessed pacing dependency following TAVR. METHODS: Consecutive patients (n = 166) with severe aortic stenosis who underwent TAVR with the Lotus valve system were prospectively recruited from a single-center. PPMs were implanted according to standard clinical criteria. Patients were followed in-hospital and at 1, 3, 6, and 12 months to determine pacemaker dependency and clinical outcomes. RESULTS: Fourteen patients with a pre-existing PPM (8%) were excluded with the remaining 152 patients aged 83.6 ± 5.6 years and 46% male. PPMs were implanted 3.8 ± 4 days post-TAVR in 38/152 patients (25%). Indication for PPM was complete heart block in 29 (76%) of patients. At 30-day and one-year follow up, 57% and 38% of patients were pacemaker dependent, respectively. The mean ventricular pacing percentage decreased in the first three months after PPM implantation and remained relatively stable after that. CONCLUSION: Only 38% of Lotus recipients who require a PPM following TAVR with the Lotus valve remain pacing dependent at one year.

Retrospective Cohort Study Examining Reduced Intensity and Duration of Anticoagulant and Antiplatelet Therapy Following Left Atrial Appendage Occlusion with the WATCHMAN Device.

BACKGROUND: Anticoagulant and antiplatelet therapy are recommended following WATCHMAN implantation (45 days and 6 months) to reduce the risk of embolic events. These patients are often also at high risk of recurrent bleeding complications. We aimed to assess the safety of reduced duration of treatment with anticoagulant and antiplatelet therapy in the early post implant period. METHODS: This was a retrospective cohort study assessing the duration of antiplatelet and anticoagulant therapy in 47 consecutive patients following WATCHMAN implant. The primary outcome was rate of major bleeding, stroke and systemic embolic complications. The secondary endpoints were rate of device thrombus and peri-device leak >4mm as assessed by transoesophogeal echocardiography. RESULTS: Forty-seven patients were followed up for a mean of 2.4+/-1.7 years (111.4 total patient-years). The rate of stroke was 1.8/100 patient-years (two events) and the rate of major bleeding complication was 8.9/100 patient-years. Three patients had peri-device leak >4mm and no patients had device thrombus visualised. 70.2% of patients had discontinued anticoagulation at 45 days, 89.4% had discontinued dual antiplatelet therapy at 90 days. Seven patients were not on any form of anticoagulant or antiplatelet at five months. Comparison of probability of survival free from stroke by time of cessation of anticoagulant and antiplatelet therapy demonstrated no significant differences (p-value for log rank test 0.238 and 0.820). CONCLUSION: Following WATCHMAN implant shortened periods of anticoagulants and antiplatelets may be considered, particularly in the context of high bleeding risk.

Aborted sudden cardiac death in a patient with implantable loop recorder.

We discuss a 46-year-old man with history of hypertension and inferior wall myocardial infarction and mild left ventricular dysfunction who presented with aborted sudden cardiac death due to episodes of ventricular tachyarrhythmia detected by a Reveal-LINQ which had been implanted one year prior to presentation.

Enhancing patient acceptance of ICD implantation through structured shared decision making: conversation is key.

BACKGROUND: Implantable cardioverter-defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-D) are lifesaving treatments for patients at risk for sudden cardiac death. Effective physician-patient communication during the shared decision-making process is essential. Electrophysiologist-patient conversations were targeted to obtain objective data on the interaction, understand the conversation framework, and uncover opportunities for improved communication. METHODS: Individuals previously identified as requiring an ICD/CRT-D but declined implantation were recruited for this four-stage interview and survey-based study. Quantitative analysis of surveys and AI analysis of conversation videos was conducted to evaluate patient participant expectations, analyze feedback about the conversations with study physicians, and gauge willingness for device implantation. RESULTS: The study included 27 patients (mean age 51 years, 51.9% female) and 9 study physicians. Patients were significantly more willing to undergo ICD/CRT-D implantation after conversing with study physicians compared to their own physicians and pre-conversation surveys (mean scores: 5.0, 3.1, and 4.4 out of 7, respectively; p < 0.001). Patient participants had higher satisfaction with the study conversation, rating study physicians higher in effectiveness of explanations, responsiveness to questions, and overall quality of the conversation compared to their own physicians (all p < 0.001). CONCLUSIONS: In a cohort of patients who previously declined ICD/CRT-D implantation, patient satisfaction and willingness to undergo implantation of a guideline-directed device therapy increased significantly following a structured conversation with study physicians. Identified key elements could be integrated into user-friendly tools and educational materials to facilitate these conversations, improving patient engagement with the decision-making process and enhancing informed acceptance of indicated device therapies.

Long-term longevity and clinical outcomes of Linox S/SD implantable cardioverter-defibrillator leads: a single-center experience.

PURPOSE: Since the introduction of the Biotronik Linox S/SD leads in 2006, there have been multiple reports of premature lead failure. The purpose of this study was to investigate the longevity of the Linox S/SD leads and to identify the possible predictors of lead failure in a single tertiary implant center. METHODS: We retrospectively reviewed patients who underwent implantation of Linox S/SD leads or Sorin Vigila 1CR/2CR leads (the same Linox S/SD leads marketed by Sorin) at our center. The cumulative lead survival was estimated using the Kaplan-Meier curve, and variables associated with lead failure were assessed by Cox proportional hazard model. RESULTS: A total of 187 patients (154 (82%) male) underwent Linox S/SD or Vigila 1CR/2CR implantation between 2007 and 2013. During follow-up with a median time of 75 months, nine lead failures were identified (4.8%). The mean and median times from lead implantation to lead failure were 70.7 ± 21 months and 64 (45-111) months, respectively. The cumulative survival probability for the Linox S/SD at 5 years was 97.1% and at 12 years was 90.3%. Non-physiological high-rate sensing was the most common type of lead failure in patients. In two-thirds of these patients, this led to inappropriate shock. We did not find any significant relationships between patients' clinical and procedural characteristics and lead failure. CONCLUSIONS: At our center, the 5-year lead survival of the Linox S/SD has been better than reports from other centers. The majority of lead failures presented as non-physiological high-rate sensing with subsequent inappropriate therapy.

An up-to-date review of cardiac pacemakers and implantable cardioverter defibrillators.

Cardiac pacemakers are one of the most frequently encountered cardiac devices seen on chest imaging. They may include single or dual chamber pacemakers, automated implantable cardioverter defibrillators (AICD), biventricular pacemakers used for cardiac resynchronisation therapy (CRT), wireless CRT, leadless pacemakers, and subcutaneous implantable cardioverter defibrillators (SICD). This review aims to provide an up-to-date review on current implantable pacemaker and defibrillator devices.

Design and Preliminary Results of Sensing and Detection for an Extravascular Implantable Cardioverter-Defibrillator.

OBJECTIVES: This study reports the sensing and arrhythmia detection performance of a novel extravascular (EV) implantable cardioverter-defibrillator (ICD) in a first-in-human pilot study. BACKGROUND: The EV ICD lead is implanted in the substernal space, resulting in novel sensing and detection challenges. It uses a programmable sensing profile with new or modified discrimination of oversensing and of ventricular tachycardia (VT) from supraventricular tachycardia (SVT). METHODS: Electrograms were post-processed from induced ventricular fibrillation (VF) at implant to determine virtual detection times for each programmable sensitivity and the least-sensitive safe sensitivity setting. In ambulatory patients, programmed sensitivity provided at least a twofold safety margin for detecting induced VF. Noise discrimination was stress tested, and the effects of source, posture, and lead maturation were determined on electrogram amplitude. Telemetry Holter monitors were used to quantify undersensing and oversensing. RESULTS: In 20 patients at implant, the least-sensitive safe sensitivity for VF detection ranged from 0.1 to 0.6 mV. Seventeen patients were followed up for a total of 16.6 patient-years. Electrogram amplitudes were stable over time, but there were significant differences among postures and sensing vectors. For the primary sensing vector, the weighted oversensing and undersensing rates were 1.03% and 0.40% respectively, on a beat-to-beat basis. Oversensing did not cause inappropriate therapy in patients with in situ leads. Oversensing discriminators withheld VF detection in 4 of 5 spontaneous, sustained oversensed episodes. SVT-VT discriminators correctly classified 93% of 128 sustained SVTs in monitor zones. CONCLUSIONS: In the EV ICD pilot study, oversensing did not cause inappropriate therapy during ambulatory follow-up of stable leads.

Junctional ectopic tachycardia (JET).

Junctional ectopic tachycardia (JET) is a tachyarrhythmia arising from the atrioventricular node and His bundle area. Enhanced normal automaticity has been postulated as the mechanism of JET in the majority of patients. It is more common in children and can be seen as congenital or in postoperative settings. It is often a narrow complex tachycardia but can present as a wide complex tachycardia as a result of aberrant conduction. Its differentiation from other arrhythmias especially atrioventricular nodal reentrant tachycardia (AVNRT) can be challenging. Medical treatment of JET is difficult, and catheter ablation remains the mainstay of treatment in refractory cases with a high risk of atrioventricular block and recurrence.

Catheter Ablation Versus Medication in Atrial Fibrillation and Systolic Dysfunction: Late Outcomes of CAMERA-MRI Study.

OBJECTIVES: This study sought to determine the long-term outcomes of restoring sinus rhythm with catheter ablation (CA). BACKGROUND: The CAMERA-MRI (Catheter Ablation Versus Medical Rate Control in Atrial Fibrillation and Heart Failure-An MRI-Guided Multicenter Randomized Controlled Trial) study demonstrated that restoration of sinus rhythm with CA significantly improved left ventricular ejection fraction (LVEF) compared with medical rate control (MRC) at 6 months in persistent atrial fibrillation and otherwise unexplained systolic heart failure. However, the long-term outcomes have not been reported. METHODS: Patients enrolled in the CAMERA-MRI study were followed for 4 years with echocardiogram and cardiac magnetic resonance. CA involved pulmonary vein isolation and posterior left atrial wall isolation in 94%. Patients crossed over to CA after 6-month study duration. Arrhythmia burden was determined with implanted cardiac monitors or cardiac devices. RESULTS: Sixty-six patients (age 62 ± 10 years, atrial fibrillation duration of 22 ± 16 months, and LVEF 33 ± 9%) were randomized 1:1 to CA versus MRC. Eighteen of 33 patients crossed over from MRC group to CA group. At 4.0 ± 0.9 years, atrial fibrillation recurred in 27 patients (57%) in the CA group with a mean burden of 10.6 ± 21.2% after 1.4 ± 0.6 procedures. There was an absolute increase in LVEF with CA of 16.4 ± 13.3% compared with 8.6 ± 7.6% in MRC (p = 0.001). In the CA group, the absence of ventricular late gadolinium enhancement was associated with a greater improvement in absolute LVEF (19 ± 13% vs. 10 ± 11% in the late gadolinium enhancement-positive group; p = 0.04) and LVEF normalization in 19 patients (58%) versus 4 patients (18%) in the late gadolinium enhancement-positive group (p = 0.008) at 4.0 ± 0.9 years follow-up. CONCLUSIONS: CA is superior to MRC in improving LVEF in the long term in patients with atrial fibrillation and systolic heart failure. The greatest recovery in systolic function was demonstrated in the absence of ventricular fibrosis on cardiac magnetic resonance.

First-in-Human Chronic Implant Experience of the Substernal Extravascular Implantable Cardioverter-Defibrillator.

OBJECTIVES: The aim of this study was to evaluate the safety and performance of an extravascular (EV) implantable cardioverter-defibrillator (ICD). BACKGROUND: Limitations of existing transvenous and subcutaneous ICD systems include lead reliability and morbidity issues associated with ICD lead implantation in the vasculature or lack of pacing therapies (e.g., antitachycardia pacing) in subcutaneous systems. The EV defibrillator uses a novel substernal lead placement to address these limitations. METHODS: This was a prospective, nonrandomized, chronic pilot study conducted at 4 centers in Australia and New Zealand. Participants were 21 patients referred for ICD implantation. Patients received EV ICD systems. Data collection included major systemic and procedural adverse events, defibrillation testing at implantation, and sensing and pacing thresholds. RESULTS: Among 20 patients who underwent successful implantation, the median defibrillation threshold was 15 J, and 90% passed defibrillation testing with a ≥10-J safety margin. Mean R-wave amplitude was 3.4 ± 2.0 mV, mean ventricular fibrillation amplitude was 2.8 ± 1.7 mV, and pacing was successful in 95% at ≤10 V. There were no intraprocedural complications. Two patients have undergone elective chronic system removal since hospital discharge. In the 15 patients presently implanted, the systems are stable in long-term follow-up. CONCLUSIONS: This first-in-human evaluation of an EV ICD demonstrated the feasibility of substernal lead placement, defibrillation, and pacing with a chronically implanted system. There were no acute major complications, and pacing, defibrillation, and sensing performance at implantation were successful in most patients. (Extravascular ICD Pilot Study [EV ICD]; NCT03608670).

Cardiac injury after percutaneous catheter ablation for atrial fibrillation.

AIMS: Small elevations in troponin T levels have been shown with limited radiofrequency (RF) ablation procedures for supraventricular tachycardia, usually to levels below the threshold for ischaemia or infarction. Left atrial catheter ablation for atrial fibrillation (AF) requires far more RF energy, therefore could be expected to have greater elevation in troponin T. We determined troponin T levels before and after ablation in these patients to evaluate the amount of rise with this ablation. METHODS: All patients undergoing pulmonary vein isolation (PVI) from May 2004 to October 2004 had troponin T levels measured 4 h following completion of the procedure. The first 30 patients also had a troponin T level measured 1 h prior to PVI to establish a baseline reference. RESULTS: Sixty patients were studied, with 81.7% males and a mean age of 54.6 +/- 9.9 years. No patient had underlying structural heart disease. The baseline troponin T level was normal (<0.01 microg/L) in all 30 patients. Post-procedure troponin T levels were elevated in all 60 patients compared with baseline (P < 0.05), with a mean level of 0.85 microg/L and a range of 0.26-1.57 microg/L after an average RF ablation time of 56 +/- 15 min. All levels were above the reference range for diagnosis of acute myocardial infarction (>0.15 microg/L). Troponin T level was not related to the number of RF lesions, RF time, procedure time, or associated external cardioversion. CONCLUSIONS: Troponin T elevations occurred in all patients undergoing PVI, to levels at least 20 times the normal concentration, into the range for diagnosis of acute myocardial infarction. Therefore, troponin T would not be specific for ischaemia in the setting of chest pain post-catheter ablation for AF.