Do depressive and anxiety symptoms influence the quality of life of patients with atrial fibrillation after cryoballoon ablation: a comparison study.

BACKGROUND AND AIMS: One third of patients with atrial fibrillation (AF) suffer from high levels of anxiety and depression, which may significantly impair quality of life (QoL). The purpose of this study was to assess whether depressive and anxiety symptoms before ablation affect the QoL in patients with AF one year after cryoballoon ablation (CBA). METHODS: This single-center retrospective study investigated whether the AF patients with a high Hospital Anxiety and Depression Scale (HADS) score (≥ 8) had worse outcomes than patients with a low pre-ablation HADS score (< 8). The primary outcome was the difference in post-ablation QoL, and the secondary outcome included the difference in pre-ablative QoL, QoL improvement, and self-reported AF. RESULTS: Two hundred ninety-five patients were stratified according to their HADS scores (total, depression, and anxiety). Patients with an elevated HADS total, depression, or anxiety score (≥ 8), had a significantly lower QoL before and 12 months after CBA than patients with a HADS score < 8 (p-value < 0.001 for all groups). All groups improved significantly in QoL after CBA ablation and to a similar extent. Sixty-three percent of the patients reported AF symptoms after the procedure, which was comparable between the cohorts of patients. CONCLUSION: Patients with elevated HADS scores reported a lower QoL compared to participants with low HADS scores at baseline and 12 months after CBA. However, both groups improved in QoL after CBA, irrespective of their depressive and anxiety symptoms.

Sex differences in characteristics of atrial fibrillation recurrence post surgical pulmonary vein isolation.

Background: Prior studies demonstrated that female sex is associated with arrhythmia recurrence after endovascular pulmonary vein isolation (PVI). However, it is unknown if the sexes differ in outcome after video assisted thoracoscopic (VATS) PVI. The aim of this study was therefore to compare characteristics of recurrent AF episodes in a matched male and female population, using implantable loop recorders for continuous rhythm monitoring. Methods: 40 matched (based on propensity score) males (age: 60.0 ± 7.71 (45-75)) and females (age: 62.0 ± 7.0 (37-74)) were retrieved from an existing database from a prior conducted study by the cardiothoracic department of the OLVG hospital (1) containing patients who received an implantable looprecorder and underwent a VATS PVI between 2012 and 2017. Patients were continuously monitored for a period of 12 months after VATS PVI and AF characteristics were compared. Results: An equal number of males and females had AF episodes during all periods (P > 0.05). The number of AF episodes was higher in females, during the first 6 months (P = 0.01, P = 0.034). During the entire follow up, the total AF duration was longer in females (P = 0.01, for all periods) with shorter inter - episode intervals (P = 0.001, P = 0001, P = 0.04) and a higher AF burden (P = 0.003, P = 0001, P = 0.006). After 3 months, AF recurrences during the night were more frequently observed in female patients (P = 0.001, P = 0.001). Conclusions: AF episodes occur frequently in both sexes after VATS PVI and warrant frequent rhythm monitoring. The observed sex differences in AF burden after VATS PVI, calls for intensive rhythm monitoring and aggressive treatment of recurrent AF epsiodes in females.

COMPARE LAAO: Rationale and design of the randomized controlled trial "COMPARing Effectiveness and safety of Left Atrial Appendage Occlusion to standard of care for atrial fibrillation patients at high stroke risk and ineligible to use oral anticoagulation therapy".

BACKGROUND: Left atrial appendage occlusion (LAAO) provides an alternative to oral anticoagulation (OAC) for stroke prevention in patients with atrial fibrillation (AF). In patients with a long-term or permanent contraindication for OAC randomized controlled trial (RCT) data is lacking. STUDY OBJECTIVES: To assess the efficacy and safety of LAAO in AF patients who are ineligible to use OAC. The co-primary efficacy endpoint is (1) time to first occurrence of stroke (ischemic, hemorrhagic, or undetermined) and (2) time to first occurrence of the composite of stroke, transient ischemic attack (TIA), and systemic embolism (SE). The primary safety endpoint is the 30-day rate of peri-procedural complications. STUDY DESIGN: This is a multicenter, investigator-initiated, open-label, blinded endpoint (PROBE), superiority-driven RCT. Patients with AF, a CHA2DS2-VASc score ≥2 for men and ≥3 for women and a long-term or permanent contraindication for OAC will be randomized in a 2:1 fashion to the device- or control arm. Patients in the device arm will undergo percutaneous LAAO and will receive post-procedural dual antiplatelet therapy (DAPT) per protocol, while those in the control arm will continue their current treatment consisting of no antithrombotic therapy or (D)APT as deemed appropriate by the primary responsible physician. In this endpoint-driven trial design, assuming a 50% lower stroke risk of LAAO compared to conservative treatment, 609 patients will be followed for a minimum of 1 and a maximum of 5 years. Cost-effectiveness and budget impact analyses will be performed to allow decision-making on reimbursement of LAAO for the target population in the Netherlands. SUMMARY: The COMPARE LAAO trial will investigate the clinical superiority in preventing thromboembolic events and cost-effectiveness of LAAO in AF patients with a high thromboembolic risk and a contraindication for OAC use. NCT TRIAL NUMBER: NCT04676880.

Strategies for repeat ablation for atrial fibrillation: A multicentre comparison of nonpulmonary vein versus pulmonary vein target ablation.

INTRODUCTION: Approximately 18% of patients with atrial fibrillation (AF) undergo a repeat ablation within 12 months after their index ablation. Despite the high prevalence, comparative studies on nonpulmonary vein (PV) target strategies in repeat AF ablation are scarce. Here, we describe 12 months efficacy of non-PV and PV target ablations as a repeat ablation strategy. METHODS: A multicentre retrospective, descriptive study was conducted with data of 280 patients who underwent repeat AF ablation. The ablation strategy for repeat ablation was at the operators' discretion. Non-PV target ablation (n = 140) included PV reisolation, posterior wall isolation, mitral line, roofline, and/or complex fractionated atrial electrogram ablation. PV target ablation (n = 140), included reisolation and/or wide atrium circumferential ablation. Patients' demographics and rhythm outcomes during 12 months follow-up were analyzed. RESULTS: At 12 months, more atrial tachyarrhythmias were observed in the non-PV target group (48.6%) compared to the PV target group (29.3%, p = .001). Similarly, a significantly higher AF and atrial tachycardia (AT) recurrence rate was observed after non-PV target ablation compared to PV target ablation (36.4% vs. 22.1% and 22.9% vs. 10.7%). After adjustment, a significantly higher risk of AT recurrence remained in the non-PV target group. Both groups significantly de-escalated antiarrhythmic drug use; de-escalation was more profound after PV target ablation. Patients with isolated PVs during non-PV target ablation had a significantly higher risk for AF recurrence than those with reconnected PVs. CONCLUSION: Compared to PV target ablation, non-PV target repeat ablation did not improve outcomes after 12 months and was independently associated with an increased risk for AT recurrences.

Intermediate-term outcome of cryoballoon ablation of persistent atrial fibrillation and improvements in quality of life of patients.

BACKGROUND: Clinical outcome of pulmonary vein isolation (PVI) has been predominantly focused on the reoccurrence of atrial fibrillation (AF) and the maintenance of sinus rhythm. However, there has been a limited intermediate follow-up on health-related quality-of-life (HRQoL) of patients. Given the relatively high recurrence rate of persistent AF after PVI treatment, it is important to follow up with clinical outcomes on symptom improvement as well as health-related quality-of-life. This study was designed to investigate the recurrence rate of atrial tachyarrhythmia (ATa), AF-related symptoms and HRQoL after PVI in patients with persistent AF who were treated with the second generation cryoballoon. METHODS: Total 148 patients participated in the study who were treated by PVI between 2013 and 2017 for persistent AF. All patients visited the out-patient clinic 2-5 years after PVI. During this visit all patients filled-out an AF Effect on Quality-of-life (AFEQT) questionnaire and a seven-day Holter was applied. All rhythm recordings acquired post ablation were collected and analysed, and the modified European Heart Rhythm Association score (mEHRA) scores were calculated before and after the ablation. RESULTS: The average age of patients was 63±9 year old and 44 (27.9%) were female. Mean CHA2DS2 VASc score was 1.9±1.4, and moderate and severe left atrial (LA) dilation was present in 53 (36.1%) and 15 (10.2%) patients, respectively. After a follow-up of 3.7±1.0 years, 81 (54.7%) patients had an ATa recurrence and 35 (23.6%) patients underwent a repeat LA ablation. However, the mEHRA score significantly improved in 80.4% of the patients (p <0.001), with the median overall AFEQT score of 88.9 [70.4-97.2]. CONCLUSIONS: There is a considerable ATa recurrence rate after PVI of persistent AF at intermediate-term follow-up. However, our data indicate that PVI significantly improved AF-related symptoms and resulted in a high HRQoL for 2-5 years in patients with persistent AF.

Practical Applications of Concomitant Pulmonary Vein Isolation and Left Atrial Appendix Closure Device Implantation.

Pulmonary vein isolation (PVI) using cryoballoon causes acute tissue edema of the osteal region of the pulmonary veins and the left atrium. In two cases combining PVI with an implantation of a left atrial appendage closure device led to malsizing of the device, device shouldering, and a paraprosthetic residual flow. (Level of Difficulty: Advanced.).

Development and external validation of prediction models to predict implantable cardioverter-defibrillator efficacy in primary prevention of sudden cardiac death.

AIMS: This study was performed to develop and externally validate prediction models for appropriate implantable cardioverter-defibrillator (ICD) shock and mortality to identify subgroups with insufficient benefit from ICD implantation. METHODS AND RESULTS: We recruited patients scheduled for primary prevention ICD implantation and reduced left ventricular function. Bootstrapping-based Cox proportional hazards and Fine and Gray competing risk models with likely candidate predictors were developed for all-cause mortality and appropriate ICD shock, respectively. Between 2014 and 2018, we included 1441 consecutive patients in the development and 1450 patients in the validation cohort. During a median follow-up of 2.4 (IQR 2.1-2.8) years, 109 (7.6%) patients received appropriate ICD shock and 193 (13.4%) died in the development cohort. During a median follow-up of 2.7 (IQR 2.0-3.4) years, 105 (7.2%) received appropriate ICD shock and 223 (15.4%) died in the validation cohort. Selected predictors of appropriate ICD shock were gender, NSVT, ACE/ARB use, atrial fibrillation history, Aldosterone-antagonist use, Digoxin use, eGFR, (N)OAC use, and peripheral vascular disease. Selected predictors of all-cause mortality were age, diuretic use, sodium, NT-pro-BNP, and ACE/ARB use. C-statistic was 0.61 and 0.60 at respectively internal and external validation for appropriate ICD shock and 0.74 at both internal and external validation for mortality. CONCLUSION: Although this cohort study was specifically designed to develop prediction models, risk stratification still remains challenging and no large group with insufficient benefit of ICD implantation was found. However, the prediction models have some clinical utility as we present several scenarios where ICD implantation might be postponed.

Elimination of Benign Ventricular Premature Beats or Ventricular Tachycardia with Catheter Ablation versus Two Different Optimal Antiarrhythmic Drug Treatment Regimens (Sotalol or Verapamil/Flecainide).

BACKGROUND: Symptomatic idiopathic ventricular arrhythmias (VA), including premature beats (VPB) and nonsustained ventricular tachycardia (VT) are commonly encountered arrhythmias. Although these VA are usually benign, their treatment can be a challenge to primary and secondary health care providers. Mainstay treatment is comprised of antiarrhythmic drugs (AAD) and, in case of drug intolerance or failure, patients are referred for catheter ablation to tertiary health care centers. These patients require extensive medical attention and drug regimens usually have disappointing results. A direct comparison between the efficacy of the most potent AAD and primary catheter ablation in these patients is lacking. The ECTOPIA trial will evaluate the efficacy of 2 pharmacological strategies and 1 interventional approach to: suppress the VA burden, improve the quality of life (QoL), and safety. HYPOTHESIS: We hypothesize that flecainide/verapamil combination and catheter ablation are both superior to sotalol in suppressing VA in patients with symptomatic idiopathic VA. STUDY DESIGN: The Elimination of Ventricular Premature Beats with Catheter Ablation versus Optimal Antiarrhythmic Drug Treatment (ECTOPIA) trial is a randomized, multicenter, prospective clinical trial to compare the efficacy of catheter ablation versus optimal AAD treatment with sotalol or flecainide/verapamil. One hundred eighty patients with frequent symptomatic VA in the absence of structural heart disease or underlying cardiac ischemia who are eligible for catheter ablation with an identifiable monomorphic VA origin with a burden ≥5% on 24-h ambulatory rhythm monitoring will be included. Patients will be randomized in a 1:1:1 fashion. The primary endpoint is defined as >80% reduction of the VA burden on 24-h ambulatory Holter monitoring. After reaching the primary endpoint, patients randomized to one of the 2 AAD arms will undergo a cross-over to the other AAD treatment arm to explore differences in drug efficacy and QoL in individual patients. Due to the use of different AAD (with and without ß-blocking characteristics) we will be able to explore the influence of alterations in sympathetic tone on VA burden reduction in different subgroups. Finally, this study will assess the safety of treatment with 2 different AAD and ablation of VA.

Contact feedback improves 1-year outcomes of remote magnetic navigation-guided ischemic ventricular tachycardia ablation.

INTRODUCTION: Remote magnetic navigation (RMN)-guided catheter ablation (CA) is a feasible treatment option for patients presenting with ischemic ventricular tachycardia (VT). Catheter-tissue contact feedback, enhances lesion formation and may consequently improve CA outcomes. Until recently, contact feedback was unavailable for RMN-guided CA. The novel e-Contact Module (ECM) was developed to continuously monitor and ensure catheter-tissue contact during RMN-guided CA. OBJECTIVE: The present study aims to evaluate the effect of ECM implementation on acute and long-term outcomes in RMN-guided ischemic VT ablation. METHOD: This retrospective, two-center study included consecutive ischemic VT patients undergoing RMN-guided CA from 2010 to 2017. Baseline clinical data, procedural data, including radiation times, and acute success rates were compared between CA procedures performed with ECM (ECM+) and without ECM (ECM-). One-year VT-free survival was analyzed using Cox-proportional hazards models, adjusting for potential confounders: age, left ventricular function, VT inducibility at baseline and substrate based ablation strategy. RESULTS: The current study included 145 patients (ECM+ N = 25, ECM- N = 120). Significantly lower fluoroscopy times were observed in the ECM+ group (9.5 (IQR 5.3-13.5) versus 12.5 min (IQR 8.0-18.0), P = 0.025). Non-inducibility of the clinical VT at the end of procedure was observed in 92% ECM+ versus 72% ECM- patients (P = 0.19). ECM guidance was associated with significantly lower VT-recurrence rates during 1-year follow-up (16% ECM+ versus 40% ECM-; multivariable HR 0.29, 95%-CI 0.10-0.69, P = 0.021, reference group: ECM-). CONCLUSION: Contact feedback by the ECM further decreases fluoroscopy exposure and improves VT-free survival in RMN-guided ischemic VT ablation.

Silent cerebral lesions and cognitive function after pulmonary vein isolation with an irrigated gold-tip catheter: REDUCE-TE Pilot study.

INTRODUCTION: Stroke is one of the most feared complications during catheter ablation of atrial fibrillation (AF). While symptomatic thromboembolic events are rare, magnetic resonance imaging (MRI) may identify asymptomatic (ie, silent) cerebral lesions (SCLs) following pulmonary vein isolation (PVI) procedures. METHODS AND RESULTS: The REDUCE-TE Pilot was a prospective multicenter, single-arm observational study investigating the incidence of SCL in patients with symptomatic paroxysmal AF undergoing PVI with a novel gold-tip, externally irrigated ablation catheter. After ablation, cerebral diffusion-weighted MRI and a postablation follow-up were performed at 1 to 3 days after the ablation procedure. A neurocognitive test was done before and after ablation. The primary study endpoint was the occurrence of one or more new SCLs. Secondary study endpoints included neurocognitive status, procedural success rate, and periprocedural complications including symptomatic thromboembolic events. A total of 104 patients were enrolled (69% male, mean age: 61.5 ± 9.7 years, mean CHA2 DS 2 -VASc score: 1.7 ± 1.2). Postprocedural MRI examination was performed in 97 patients, and in nine of them (9.3%; 95% CI: 4.3-16.9%) a total of 11 SCLs were detected. Univariate analyses did not reveal any significant predictor for new SCLs. Nonsignificant trends were observed for low activated clotting time during ablation and for international normalized ratio value outside the range of 2 to 3 at ablation. There was no evidence of significant deterioration of neurocognitive function after PVI. In four patients, a pericardial tamponade was noted but all patients fully recovered during follow-up. CONCLUSIONS: Ablation of AF using a novel gold-tip, externally irrigated ablation catheter, resulted in SCLs in approximately one out of 10 patients without a measurable effect on neurocognitive function.

Disappearance of Idiopathic Outflow Tract Premature Ventricular Contractions After Catheter Ablation of Overt Accessory Pathways.

BACKGROUND: Multiple mechanisms have been proposed for idiopathic premature ventricular contractions (PVCs) originating from the outflow tracts (OTs). Recent observations such as the coexistence of these arrhythmias with atrioventricular nodal reentrant tachycardias and the association between discrete prepotentials and successful ablation sites of ventricular arrhythmias (VAs) from the OTs suggest a common link. OBJECTIVE: In this case series we draw attention to a unique association between accessory pathways (APs) and idiopathic PVCs from the OTs, disappearing after AP ablation. METHODS: We identified 6 cases in collaboration with several international electrophysiology centers, which presented with pre-excitation in association with OT, and in 1 case inflow tract (IT), PVCs on 12-lead surface ECG. RESULTS: Six cases displayed pre-excitation and PVCs, in 5 cases originating from the right ventricular outflow tract (RVOT) and in 1 case from the right ventricular inflow tract (RVIT). In all patients, PVCs were monomorphic and had fixed coupling intervals, in 3 cases presenting in bigeminy. Catheter ablation of the AP led to the simultaneous disappearance of PVCs in 5 of 6 cases. The sites of ablation were remote from the OTs in all these cases. In most cases, the occurrence of OT PVCs was closely associated with the presence of pre-excitation. CONCLUSION: The coexistence of pre-excitation and PVCs from the OTs and the fact that in 5 of 6 cases PVCs disappeared after AP ablation suggests a common mechanism for arrhythmia genesis.

Ventricular tachycardia in ischemic cardiomyopathy; a combined endo-epicardial ablation as the first procedure versus a stepwise approach (EPILOGUE) - study protocol for a randomized controlled trial.

BACKGROUND: The role of epicardial substrate ablation of ventricular tachycardia (VT) as a first-line approach in patients with ischemic heart disease is not clearly defined. Epicardial ablation as a first-line option is standard for patients with nonischemic dilated cardiomyopathy and arrhythmogenic right ventricular cardiomyopathy. Several nonrandomized studies, including studies on patients with ischemic heart disease, have shown that epicardial VT ablation improves outcome but this approach was often used after a failed endocardial approach. The aim of this study is to determine whether a combined endo-epicardial scar homogenization as a first-line approach will improve the outcome of VT ablation. METHODS/DESIGN: The EPILOGUE study is a multicenter, two-armed, nonblinded, randomized controlled trial. Patients with ischemic heart disease who are referred for VT ablation will be randomly assigned to combined endo-epicardial scar homogenization or endocardial scar homogenization only (control group). The primary outcome is recurrence of sustained VT during a 2-year follow-up. Secondary outcomes include procedural success and safety. DISCUSSION: This study is the first randomized trial that evaluates the role of a combined endo-epicardial scar homogenization versus endocardial scar homogenization for the treatment of ischemic scar-related VT. TRIAL REGISTRATION: NL4816807814v02.

Safety and Clinical Outcome of Catheter Ablation of Ventricular Arrhythmias Using Contact Force Sensing: Consecutive Case Series.

BACKGROUND: Poor catheter-to-myocardial contact can lead to ineffective ablation lesions and suboptimal outcome. Contact force (CF) sensing catheters in ventricular tachyarrhythmia (VT) ablations have not been studied for their long-term efficacy. PURPOSE: The aim of this study was to compare CF ablation to manual ablation (MAN) and remote magnetic navigation (RMN) ablation for safety and efficacy in acute and long-term outcome. METHODS: A total of 239 consecutive patients who underwent VT ablation with the use of MAN, CF, or RMN catheters were included in this single-center cohort study from January 2007 until March 2014. The primary endpoints were procedural success, acute major complications, and VT recurrences at follow-up. The median follow-up period was 25 months. RESULTS: Acute success was achieved in 182 out of 239 procedures (76%). Acute success in manual ablation, CF ablation and RMN ablation was 71%, 71%, and 86%, respectively (P = 0.03). Major complications occurred in 3.3% and there were less major complications (P = 0.04) in the RMN group. After an initial successful procedure, 66 of 182 patients (36%) had a recurrence during follow-up. This was not significantly different between groups. Using an intention-to-treat analysis, 124 patients (52%) had a recurrence. The recurrence rate was lowest in the RMN group. CONCLUSION: The use of CF sensing catheters did not improve procedural outcome or safety profile in comparison to non-CF sensing ablation in this observational study of ventricular arrhythmia ablations.

A new approach to determine the results of minimally invasive pulmonary vein isolation using a continuous loop monitor: preliminary results.

OBJECTIVES: Surgical ablation is a well-known treatment for atrial fibrillation (AF); however, little is known about the absolute success rate. The aim of this study is to compare the absolute pre- and postoperative incidence of AF after minimally invasive surgical ablation for paroxysmal AF. METHODS: Twenty consecutive patients (mean age 55 ± 8; 55% male) received a continuous loop monitor (CLM) 4 weeks prior to a minimally invasive pulmonary vein isolation (MIPVI). The mean preoperative AF burden was compared with the mean AF burden during follow-up. Follow-up was achieved for a period of 12 months. RESULTS: Seventeen patients underwent an MIPVI successfully. Two patients did not reach the threshold for surgery. In 1 patient, surgery was discontinued because of a perioperative bleeding due to adhesions after a previous percutaneous AF ablation. Mean AF burden preoperatively was 66%. After 12 months, there was an absolute reduction in AF burden of 65% (95% CI 42-88, P < 0.001) and 12 of 15 patients in follow-up (80%) were free of AF without antiarrhythmic drugs (AADs). CONCLUSIONS: The use of a CLM in the follow-up of surgical ablation is a very accurate way to confirm absolute surgical results. Furthermore, with the use of a CLM, preoperative evaluation can be done more accurately, and the surgical procedure can be adjusted to the patients' needs.

Rotational coronary sinus venography and magnetic navigation to facilitate LV lead placement in cardiac resynchronization therapy.

This report demonstrates the production and use of 3-D reconstruction of a coronary sinus from a single-injection rotational angiogram. The detailed virtual model enabled easy magnetic navigation of a wire for device placement in cardiac resynchronization therapy.

Oral administration of glycine in the prevention of restenosis after coronary angioplasty. A double blind placebo controlled randomized feasibility trial evaluating safety and efficacy of glycine in the prevention of restenosis after angioplasty.

OBJECTIVES: Evaluation of safety, feasibility, and efficacy of oral administered glycine in prevention of angiographic restenosis six months after percutaneous coronary intervention (PCI). BACKGROUND: The amino acid glycine modulates immunological response and enhances the production of endothelial derived nitric oxide (EDNO) factor. This factor has been shown to possess anti-atherosclerotic properties, actions of which are thought to reduce neo-intimal hyperplasia. Furthermore, glycine significantly elevates arginine serum levels. This amino acid has been extensively studied for its effects on the endothelium, nitric oxide (NO) metabolism and effects on several biochemical pathways interfering with the process of restenosis after PCI. METHODS: A prospective double blind placebo controlled randomized study evaluated safety and feasibility of chronic oral administration of glycine. In addition, the efficacy was determined by evaluation of six months angiographic restenosis rates. RESULTS: 214 patients scheduled for elective PCI were randomized to receive glycine or placebo. At follow-up, there was no significant difference in side effects and in major adverse cardiac events (MACE) between both groups. Six-month angiograms revealed similar restenosis rates for the glycine group (17.5%) and for the placebo group (20.2%) (P = 0.82). CONCLUSION: Chronic oral administration of glycine was safe and feasible and had similar side effects compared to placebo. However, chronic oral administration of glycine did not lead to a significant reduction in restenosis rates at six months after elective PCI.