Left Atrial Appendage Occlusion vs Standard of Care After Ischemic Stroke Despite Anticoagulation.

Importance: Patients with atrial fibrillation (AF) who have ischemic stroke despite taking oral anticoagulation therapy (OAT) have a very high risk of recurrence. Left atrial appendage occlusion (LAAO) is a mechanical stroke prevention strategy that may provide additional protection in patients with thromboembolic events under OAT. Objective: To compare percutaneous LAAO with continuing OAT alone regarding stroke prevention in patients with AF who had a thromboembolic event despite taking OAT. Design, Setting, and Participants: This cohort study was a propensity score-matched comparison of the STR-OAC LAAO cohort, an international collaboration of 21 sites combining patients from multiple prospective registries of patients who underwent LAAO between 2010 and 2022. STR-OAC LAAO cohort patients who had follow-up longer than 3 months were propensity score-matched to a previously published control cohort comprising patients from an established international collaboration of investigator-initiated prospective studies. This control cohort included patients with nonvalvular AF, recent ischemic stroke or transient ischemic attack, and follow-up longer than 3 months who were taking OAT before the index event. Analyses were adjusted for imbalances in gender, age, hypertension, diabetes, and CHA2 DS2-VASc score. Exposure: Left atrial appendage occlusion vs continuation of oral anticoagulation therapy alone (control group). Main Outcomes and Measures: The primary outcome was time to first ischemic stroke. Results: Four hundred thirty-three patients from the STR-OAC LAAO cohort (mean [SD] age, 72 [9] years; 171 [39%] females and 262 [61%] males; mean [SD] CHA2 DS2-VASc score, 5.0 [1.6]) were matched to 433 of 1140 patients (38%) from the control group. During 2-year follow-up, 50 patients experienced ischemic stroke: an annualized event rate of 2.8% per patient-year in the STR-OAC LAAO group vs 8.9% per patient-year in the control group. Left atrial appendage occlusion was associated with a lower risk of ischemic stroke (hazard ratio, 0.33; 95% CI, 0.19-0.58; P < .001) compared with the control group. After LAAO, OAT was discontinued in 290 patients (67%), and the remaining 143 patients (33%) continued OAT after LAAO as an adjunctive therapy. Conclusions and Relevance: In patients with nonvalvular AF and a prior thromboembolic event despite taking OAT, LAAO was associated with a lower risk of ischemic stroke compared with continued OAT alone. Randomized clinical trial data are needed to confirm that LAAO may be a promising treatment option for this population with a very high risk of stroke.

Trends in adoption of extravascular cardiac implantable electronic devices: the Dutch cohort.

INTRODUCTION: Conventional implantable cardioverter-defibrillators (ICDs) and pacemakers carry a risk of pocket- and lead-related complications in particular. To avoid these complications, extravascular devices (EVDs) have been developed, such as the subcutaneous ICD (S-ICD) and leadless pacemaker (LP). However, data on patient or centre characteristics related to the actual adoption of EVDs are lacking. OBJECTIVE: To assess real-world nationwide trends in EVD adoption in the Netherlands. METHODS: Using the Netherlands Heart Registration, all consecutive patients with a de novo S­ICD or conventional single-chamber ICD implantation between 2012-2020, or de novo LP or conventional single-chamber pacemaker implantation between 2014-2020 were included. Trends in adoption are described for various patient and centre characteristics. RESULT: From 2012-2020, 2190 S­ICDs and 10,683 conventional ICDs were implanted; from 2014-2020, 712 LPs and 11,103 conventional pacemakers were implanted. The general use has increased (S-ICDs 8 to 21%; LPs 1 to 8%), but this increase seems to have reached a plateau. S­ICD recipients were younger than conventional ICD recipients (p < 0.001) and more often female (p < 0.001); LP recipients were younger than conventional pacemaker recipients (p < 0.001) and more often male (p = 0.03). Both S­ICDs and LPs were mainly implanted in high-volume centres with cardiothoracic surgery on-site, although over time S­ICDs were increasingly implanted in centres without cardiothoracic surgery (p < 0.001). CONCLUSION: This nationwide study demonstrated a relatively quick adoption of innovative EVDs with a plateau after approximately 4 years. S­ICD use is especially high in younger patients. EVDs are mainly implanted in high-volume centres with cardiothoracic surgery back-up, but S­ICD use is expanding beyond those centres.

Left Atrial Appendage Occlusion in Patients With Anticoagulation Failure vs Anticoagulation Contraindication.

BACKGROUND: Left atrial appendage occlusion (LAAO) provides mechanical cardioembolic protection for atrial fibrillation (AF) patients who cannot use oral anticoagulation therapy (OAT). Patients with a thrombotic event despite OAT are at high risk for recurrence and may also benefit from LAAO. OBJECTIVES: This study sought to investigate the efficacy of LAAO in AF patients with a thrombotic event on OAT compared to: 1) LAAO in AF patients with a contraindication for OAT; and 2) historical data. METHODS: The international LAAO after stroke despite oral anticoagulation (STR-OAC LAAO) collaboration included patients who underwent LAAO because of thrombotic events on OAT. This cohort underwent propensity score matching and was compared to the EWOLUTION (Evaluating Real-Life Clinical Outcomes in Atrial Fibrillation Patients Receiving the WATCHMAN Left Atrial Appendage Closure Technology) registry, which represents patients who underwent LAAO because of OAT contraindications. The primary outcome was ischemic stroke. Event rates were compared between cohorts and with historical data without OAT, yielding relative risk reductions based on risk scores. RESULTS: Analysis of 438 matched pairs revealed no significant difference in the ischemic stroke rate between the STR-OAC LAAO and EWOLUTION cohorts (2.5% vs 1.9%; HR: 1.37; 95% CI: 0.72-2.61). STR-OAC LAAO patients exhibited a higher thromboembolic risk (HR: 1.71; 95% CI: 1.04-2.83) but lower bleeding risk (HR: 0.39; 95% CI: 0.18-0.88) compared to EWOLUTION patients. The mortality rate was slightly higher in EWOLUTION (4.3% vs 6.9%; log-rank P = 0.028). Relative risk reductions for ischemic stroke were 70% and 78% in STR-OAC LAAO and EWOLUTION, respectively, compared to historical data without OAT. CONCLUSIONS: LAAO in patients with a thrombotic event on OAT demonstrated comparable stroke rates to the OAT contraindicated population in EWOLUTION. The thromboembolic event rate was higher and the bleeding rate lower, reflecting the intrinsically different risk profile of both populations. Until randomized trials are available, LAAO may be considered in patients with an ischemic event on OAT.

Cardioversion strategy impacts rate control during recurrences in patients with paroxysmal atrial fibrillation: A subanalysis of the RACE 7 ACWAS trial.

BACKGROUND: In the Rate Control versus Electrical Cardioversion Trial 7-Acute Cardioversion versus Wait and See, patients with recent-onset atrial fibrillation (AF) were randomized to either early or delayed cardioversion. AIM: This prespecified sub-analysis aimed to evaluate heart rate during AF recurrences after an emergency department (ED) visit identified by an electrocardiogram (ECG)-based handheld device. METHODS: After the ED visit, included patients (n = 437) were asked to use an ECG-based handheld device to monitor for recurrences during the 4-week follow-up period. 335 patients used the handheld device and were included in this analysis. Recordings from the device were collected and assessed for heart rhythm and rate. Optimal rate control was defined as a target resting heart rate of <110 beats per minute (bpm). RESULTS: In 99 patients (29.6%, mean age 67 ± 10 years, 39.4% female, median 6 [3-12] AF recordings) a total of 314 AF recurrences (median 2 [1-3] per patient) were identified during follow-up. The average median resting heart rate at recurrence was 100 ± 21 bpm in the delayed vs 112 ± 25 bpm in the early cardioversion group (p = .011). Optimal rate control was seen in 68.4% [21.3%-100%] and 33.3% [0%-77.5%] of recordings (p = .01), respectively. Randomization group [coefficient -12.09 (-20.55 to -3.63, p = .006) for delayed vs. early cardioversion] and heart rate on index ECG [coefficient 0.46 (0.29-0.63, p < .001) per bpm increase] were identified on multivariable analysis as factors associated with lower median heart rate during AF recurrences. CONCLUSION: A delayed cardioversion strategy translated into a favorable heart rate profile during AF recurrences.

Dielectric response as a novel marker for ablation lesion quality: Relation to conventional ablation parameters.

Background: The tissue response viewer (TRV) is a novel marker for ablation lesion quality that aims to classify lesions into transmural or nontransmural lesions (high or low dielectric response, HDR or LDR) using dielectric-based tissue assessment. The objective of this study was to gain insight in the TRV by relating its outcomes to conventional ablation parameters. Methods: Patients that had repeat ablation for atrial fibrillation with a dielectric imaging-based mapping system were enrolled. All ablation data were downloaded from the mapping system and analyzed to explore associations between TRV outcomes and other ablation parameters. Results: The cohort included 24 patients, in which 58 pulmonary veins and 8 superior vena cavas were targeted. A total of 388 energy applications were applied, resulting in 639 ablation points. The system classified 36% of ablation points as HDR and 44% as LDR. The system did not provide a dielectric response in 20%. The system's ability to provide a dielectric response was related to longer ablation duration and absence of dragging ablation. HDR (versus LDR) was multivariably associated with longer energy applications, higher mean ablation power, and lower wall thickness. Greater impedance drop was univariably associated with HDR. Conclusion: Outcomes of the TRV are associated with conventional ablation parameters (e.g., duration and power) but also local wall thickness. Catheter stability seems important for successful lesion assessment with the TRV. Further reduction of missing outcomes and validation of the tool are warranted before widespread use.

High-density mapping for ablation of atypical atrial flutters - procedural characteristics related to outcome.

BACKGROUND: High-density (HD) mapping is increasingly used to characterize arrhythmic substrate for ablation of atypical atrial flutters (AAFl). However, results on clinical outcomes and factors that are associated with arrhythmia recurrence are scarce. METHODS: Single-center, prospective, observational cohort study that enrolled patients with catheter ablation for AAFl using a HD mapping system and a grid-shaped mapping catheter. Procedural characteristics, rates of atrial flutter recurrence, and factors that were associated with atrial flutter recurrence were evaluated. RESULTS: Sixty-one patients with a total of 94 AAFl were included in the cohort. HD mapping was used to successfully identify the flutter circuit of 80/94 AAFl. The circuit was not identified for 14/94 AAFl in 11 patients. Critical isthmuses were identified and ablated in 29 patients (48%). Acute procedural success was achieved in 52 patients (85%), and 37 patients (61%) remained free from atrial flutter recurrence during a follow up of 1.3 [1.0-2.1] years. Atrial flutter recurrence was univariably associated with presence of a non-identified flutter circuit (HR:2.6 95% CI [1.1-6.3], p = .04) and critical isthmus-targeted ablation (HR:0.4 [0.15-0.90], p = .03). In multivariable regression analyses, critical isthmus ablation remained significant (HR:0.4 [0.16-0.97], p = .04), whereas presence of a non-identified flutter did not (HR:2.4 [0.96-5.8], p = .06). CONCLUSION: HD mapping was successfully used to identify the majority of AAFl circuits. Ablation resulted in freedom from atrial flutter recurrence in 61% of the cohort. Successful identification of all flutter circuits and critical isthmuses appears to be beneficial for long-term outcomes.

Long-term outcomes of successful left atrial appendage occlusion with focus on stroke prevention: 10-year follow-up of a single-center registry.

Background: Percutaneous left atrial appendage occlusion (LAAO) is an alternative to anticoagulation in the prevention of stroke in patients with nonvalvular atrial fibrillation, especially in patients with a contraindication for oral anticoagulation therapy (OAT). Objective: The study sought to obtain long-term patient outcomes after successful LAAO in everyday clinical practice. Methods: In this single-center registry spanning over 10 years, data of all consecutive patients that underwent percutaneous LAAO were collected. Observed thromboembolic and major bleeding event rates after successful LAAO during follow-up were compared with expected event rates based on CHA2DS2-VASc (congestive heart failure, hypertension, age ≥75 years, diabetes mellitus, prior stroke or transient ischemic attack or thromboembolism, vascular disease, age 65-74 years, sex category) and HAS-BLED (hypertension, abnormal renal or liver function, stroke, bleeding, labile international normalized ratio, elderly, drugs or alcohol) scores. Furthermore, anticoagulation and antiplatelet use during follow-up was evaluated. Results: Of 230 patients scheduled for LAAO (38% women, 69.5 ± 8.2 years of age, CHA2DS2-VASc score 3.9 ± 1.6, HAS-BLED score 2.9 ± 1.0), 218 patients had a successful implantation (95%) with a follow-up duration of 5.2 ± 3.1 years. The procedure was combined with catheter ablation in 52% of the patients. Fifty thromboembolic complications (24 ischemic stroke, 26 transient ischemic attack) were observed during follow-up in 40 (18%) of 218 patients. Ischemic strokes occurred with a rate of 2.1 per 100 patient-years, accounting for a 66% relative risk reduction compared with the CHA2DS2-VASc predicted event rate. Device-related thrombus was observed in 5 (2%) patients. Sixty-five nonprocedural major bleeding complications occurred in 24 (11%) of 218 patients with a rate of 5.7 per 100-patient years, which is comparable to estimated HAS-BLED-bleeding rates under OAT use. At end of follow-up 71% of all patients were on single antiplatelet or no antiplatelet or anticoagulation treatment, while 29% were on OAT. Conclusion: Thromboembolic event rates during long-term follow-up after successful LAAO remained consistently lower than expected supporting the efficacy of LAAO.

Five-year safety and efficacy of leadless pacemakers in a Dutch cohort.

BACKGROUND: Adequate real-world safety and efficacy of leadless pacemakers (LPs) have been demonstrated up to 3 years after implantation. Longer-term data are warranted to assess the net clinical benefit of leadless pacing. OBJECTIVE: The purpose of this study was to evaluate the long-term safety and efficacy of LP therapy in a real-world cohort. METHODS: In this retrospective cohort study, all consecutive patients with a first LP implantation from December 21, 2012, to December 13, 2016, in 6 Dutch high-volume centers were included. The primary safety endpoint was the rate of major procedure- or device-related complications (ie, requiring surgery) at 5-year follow-up. Analyses were performed with and without Nanostim battery advisory-related complications. The primary efficacy endpoint was the percentage of patients with a pacing capture threshold ≤2.0 V at implantation and without ≥1.5-V increase at the last follow-up visit. RESULTS: A total of 179 patients were included (mean age 79 ± 9 years), 93 (52%) with a Nanostim and 86 (48%) with a Micra VR LP. Mean follow-up duration was 44 ± 26 months. Forty-one major complications occurred, of which 7 were not advisory related. The 5-year major complication rate was 4% without advisory-related complications and 27% including advisory-related complications. No advisory-related major complications occurred a median 10 days (range 0-88 days) postimplantation. The pacing capture threshold was low in 163 of 167 patients (98%) and stable in 157 of 160 (98%). CONCLUSION: The long-term major complication rate without advisory-related complications was low with LPs. No complications occurred after the acute phase and no infections occurred, which may be a specific benefit of LPs. The performance was adequate with a stable pacing capture threshold.

Long-term success of a multi-electrode substrate mapping and ablation strategy versus a classic single tip mapping and ablation strategy for ventricular tachycardia ablation in patients with ischemic cardiomyopathy.

INTRODUCTION: Over the past years, mapping and ablation techniques for the treatment of ventricular tachycardia (VT) have evolved rapidly. High Density (HD) substrate mapping is now routine and pre-procedural imaging is increasingly used. The additional value of these techniques for long-term VT-free survival is not clear. METHODS: We compared baseline and procedural characteristics, procedural success, safety and outcome of mapping and ablation of ventricular tachycardia in patients with ischemic heart disease between two groups. (1) Low Density (LD) group: VT mapping and ablation with a 4 mm single tip catheter (2) HD group: HD substrate mapping with the Pentaray (Biosense Webster, USA) or HD Grid (Abbott, USA) catheter and ablation with a 4 mm single tip catheter. RESULTS: VT ablation was performed in 133 patients (71 patients in LD group and 62 patients in HD group). The median follow-up was 5.0 years in LD group and 2.0 years in HD group. One-, two-, and five-year VT recurrence rates were 47%, 56%, and 65% in the LD group versus 39%, 50%, and 55% in the HD group (log-rank test for VT recurrence p = .70). One-, two-, and five-year ICD shock recurrence rates were 14%, 18%, and 24% in the LD group versus 8%, 15%, and 19% in the HD group (log-rank test for ICD-shock p = .79). All-cause mortality, cardiac (non-arrhythmic), and arrhythmic death, were similar in both groups. Severe procedural complications (tamponade, stroke, or procedural death) occurred in four patients (5%, 1 vascular, 3 tamponade) in the LD group versus two patients (3%, both tamponade) in the HD group (NS). In univariate and multivariable analysis, only a higher LVEF was significantly associated with VT-free survival. HD mapping was not significantly associated with VT-free survival. Anterior infarct location and age were significantly associated with ICD recurrent shock in both univariate and multivariable analyses. CONCLUSIONS: In patients with ischemic cardiomyopathy, a HD substrate mapping, and ablation strategy did not lead to higher VT-free survival and shock-free survival compared to a single tip mapping and ablation strategy. In this study, only LVF is an independent predictor for VT recurrence. Anterior infarct location and age predict recurrent ICD shocks.

NL-EVDR: Netherlands-ExtraVascular Device Registry.

Cardiac implantable electronic device (CIED) therapy is an essential element in treating cardiac arrhythmias. Despite their benefits, conventional transvenous CIEDs are associated with a significant risk of mainly pocket- and lead-related complications. To overcome these complications, extravascular devices (EVDs), such as the subcutaneous implantable cardioverter-defibrillator and intracardiac leadless pacemaker, have been developed. In the near future, several other innovative EVDs will become available. However, it is difficult to evaluate EVDs in large studies because of high costs, lack of long-term follow-up, imprecise data or selected patient populations. To improve evaluation of these technologies, real-world, large-scale, long-term data are of utmost importance. A Dutch registry-based study seems to be a unique possibility for this goal due to early involvement of Dutch hospitals in novel CIEDs and an existing quality control infrastructure, the Netherlands Heart Registration (NHR). Therefore, we will soon start the Netherlands-ExtraVascular Device Registry (NL-EVDR), a Dutch nationwide registry with long-term follow-up of EVDs. The NL-EVDR will be incorporated in NHR's device registry. Additional EVD-specific variables will be collected both retrospectively and prospectively. Hence, combining Dutch EVD data will provide highly relevant information on safety and efficacy. As a first step, a pilot project has started in selected centres in October 2022 to optimise data collection.

On-screen image-guided lead placement in cardiac resynchronization therapy: Feasibility and outcome in a multicenter setting.

Background: Image guidance to assist left ventricular (LV) lead placement may improve outcome after cardiac resynchronization therapy (CRT), but previous approaches and results varied greatly, and multicenter feasibility is lacking altogether. Objective: We sought to investigate the multicenter feasibility of image guidance for periprocedural assistance of LV lead placement for CRT. Methods: In 30 patients from 3 hospitals, cardiac magnetic resonance imaging was performed within 3 months prior to CRT to identify myocardial scar and late mechanical activation (LMA). LMA was determined using radial strain, plotted over time. Segments without scar but clear LMA were classified as optimal for LV lead placement, according to an accurate 36-segment model of the whole heart. LV leads were navigated using image overlay with periprocedural fluoroscopy. After 6 months, volumetric response and super-response were defined as ≥15% or ≥30% reduction in LV end-systolic volume, respectively. Results: Periprocedural image guidance was successfully performed in all CRT patients (age 66 ± 10 years; 59% men, 62% with nonischemic cardiomyopathy, 69% with left bundle branch block). LV leads were placed as follows: within (14%), adjacent (62%), or remote (24%) from the predefined target. According to the conventional 18-segment model, a remote position occurred only once (3%). On average, 86% of patients demonstrated a volumetric response (mean LV end-systolic volume reduction 36 ± 29%), and 66% of all patients were super-responders. Conclusion: On-screen image guidance for LV lead placement in CRT was feasible in a multicenter setting. Efficacy will be further investigated in the randomized controlled ADVISE (Advanced Image Supported Lead Placement in Cardiac Resynchronization Therapy) trial (NCT05053568).

Mobile health adherence for the detection of recurrent recent-onset atrial fibrillation.

OBJECTIVE: The Rate Control versus Electrical Cardioversion Trial 7-Acute Cardioversion versus Wait and See trial compared early to delayed cardioversion for patients with recent-onset symptomatic atrial fibrillation (AF). This study aims to evaluate the adherence to a 4-week mobile health (mHealth) prescription to detect AF recurrences after an emergency department visit. METHODS: After the emergency department visit, the 437 included patients, irrespective of randomisation arm (early or delayed cardioversion), were asked to record heart rate and rhythm for 1 min three times daily and in case of symptoms by an electrocardiography-based handheld device for 4 weeks (if available). Adherence was appraised as number of performed measurements per number of recordings asked from the patient and was evaluated for longitudinal adherence consistency. All patients who used the handheld device were included in this subanalysis. RESULTS: 335 patients (58% males; median age 67 (IQR 11) years) were included. The median overall adherence of all patients was 83.3% (IQR 29.9%). The median number of monitoring days was 27 out of 27 (IQR 5), whereas the median number of full monitoring days was 16 out of 27 (IQR 14). Higher age and a previous paroxysm of AF were identified as multivariable adjusted factors associated with adherence. CONCLUSIONS: In this randomised trial, a 4-week mHealth prescription to monitor for AF recurrences after an emergency department visit for recent-onset AF was feasible with 85.7% of patients consistently using the device with at least one measurement per day. Older patients were more adherent. TRIAL REGISTRATION NUMBER: NCT02248753.

Long-term monitoring of arrhythmias with cardiovascular implantable electronic devices in patients with cardiac sarcoidosis.

BACKGROUND: Risk stratification for sudden cardiac death (SCD) in cardiac sarcoidosis (CS) is challenging in patients without overt cardiac symptoms. OBJECTIVE: The purpose of this study was to determine the incidence of ventricular arrhythmias (VAs) and mortality after long-term monitoring with a cardiovascular implantable electronic device (CIED) in CS patients identified after systematic screening of patients with extracardiac sarcoidosis (ECS). METHODS: A retrospective study was performed in 547 predominantly Caucasian patients with ECS screened for cardiac involvement. If CS was diagnosed, risk stratification (high vs low risk) for SCD was performed by a multidisciplinary team. The primary endpoint was defined as sustained VA, appropriate implantable cardioverter-defibrillator (ICD) therapy, or cardiac death. RESULTS: In total, 105 patients were included (mean follow-up 33 ± 16 months). An ICD was implanted in 17 high-risk patients (16.2%), whereas 80 low-risk patients (76.1%) received an implantable loop recorder (ILR). Eight low-risk patients (7.6%) did not receive a device. The primary endpoint occurred in 4.8% (n = 5), with an overall annualized event rate of 1.7%. The annualized event rate was 9.8% in high-risk patients and 0.4% in low-risk patients. Nine low-risk patients received an ICD during follow-up, in 7 patients as a result of the ILR recordings. None of these patients required ICD therapy. CONCLUSION: In CS patients without overt cardiac symptoms at initial presentation the annualized overall event rate was 1.7%; 10% in high-risk patients, but only 0.4% in low-risk patients. In low-risk patients long-term arrhythmia monitoring with an ILR enabled early detection of clinically important arrhythmias without showing impact on prognosis.

Non-transvenous ICD therapy: current status and beyond.

Subcutaneous implantable cardioverter/defibrillators (S-ICDs) have been developed to offer ICD treatment to patients without venous access to the heart and to overcome complications associated with transvenous leads, particularly lead fracture/insulation defects and endocarditis. Several studies and registries have demonstrated the feasibility and safety of S­ICD in different groups of patients. Further developments in S­ICD technology involve the combination with devices that can provide anti-bradycardia and anti-tachycardia pacing if needed. The extravascular ICD (EV-ICD) is a new system that similarly offers ICD therapy without a transvenous lead but uses a substernal instead of a subcutaneous lead to facilitate detection of ventricular fibrillation and to provide anti-tachycardia and also temporary anti-bradycardia pacing. The first animal but also clinical data on EV-ICDs have been published. This review discusses the current state, potential advantages and limitations, and future research of both S­ICD and EV-ICD.

Advanced image-supported lead placement in cardiac resynchronisation therapy: protocol for the multicentre, randomised controlled ADVISE trial and early economic evaluation.

INTRODUCTION: Achieving optimal placement of the left ventricular (LV) lead in cardiac resynchronisation therapy (CRT) is a prerequisite in order to achieve maximum clinical benefit, and is likely to help avoid non-response. Pacing outside scar tissue and targeting late activated segments may improve outcome. The present study will be the first randomised controlled trial to compare the efficacy of real-time image-guided LV lead delivery to conventional CRT implantation. In addition, to estimate the cost-effectiveness of targeted lead implantation, an early decision analytic model was developed, and described here. METHODS AND ANALYSIS: A multicentre, interventional, randomised, controlled trial will be conducted in a total of 130 patients with a class I or IIa indication for CRT implantation. Patients will be stratified to ischaemic heart failure aetiology and 1:1 randomised to either empirical lead placement or live image-guided lead placement. Ultimate lead location and echocardiographic assessment will be performed by core laboratories, blinded to treatment allocation and patient information. Late gadolinium enhancement cardiac magnetic resonance imaging (CMR) and CINE-CMR with feature-tracking postprocessing software will be used to semi-automatically determine myocardial scar and late mechanical activation. The subsequent treatment file with optimal LV-lead positions will be fused with the fluoroscopy, resulting in live target-visualisation during the procedure. The primary endpoint is the difference in percentage of successfully targeted LV-lead location. Secondary endpoints are relative percentage reduction in indexed LV end-systolic volume, a hierarchical clinical endpoint, and quality of life. The early analytic model was developed using a Markov-model, consisting of seven mutually exclusive health states. ETHICS AND DISSEMINATION: The protocol was approved by the Medical Research Ethics Committee Utrecht (NL73416.041.20). All participants are required to provide written informed consent. Results will be submitted to peer-reviewed journals. TRIAL REGISTRATION NUMBER: NCT05053568; Trial NL8666.

Efficacy and safety of the GOLD FORCE multicentre randomized clinical trial: multielectrode phased radiofrequency vs. irrigated radiofrequency single-tip catheter with contact force ablation for treatment of symptomatic paroxysmal atrial fibrillation.

AIMS: Pulmonary vein isolation (PVI) for atrial fibrillation (AF) has become increasingly safe and effective with the evolution of single-tip ablation catheters aided by contact force sensing (ST-CF) and single-shot devices such as the second-generation pulmonary vein ablation catheter (PVAC) Gold multi-electrode array. The multicentre randomized GOLD FORCE trial was conducted to evaluate non-inferiority of safety and efficacy of PVAC Gold PVI compared to ST-CF ablation for paroxysmal AF. METHODS AND RESULTS: The primary efficacy endpoint documented AF recurrence ≥30 s was assessed by time-to-first-event analysis after a 90-day blanking period using repeated 7-day Holters. Secondary endpoints include acute success and procedural characteristics. Safety endpoints included procedural complications, stroke/transient ischaemic attack (TIA), tamponade, bleeding, and access site complications. Two hundred and eight patients underwent randomization and PVI (103 assigned to PVAC Gold, 105 to ST-CF). Acute success rates were 95% and 97% for PVAC Gold and ST-CF, respectively. At 12 months, AF recurrence was observed in 46.6% of the PVAC Gold group and in 26.2% of the ST-CF group [absolute efficacy difference 20.4% (95% confidence interval, CI 7.5-33.2%), hazard ratio 2.05 (95% CI 1.28-3.29), P = 0.003]. PVAC Gold had significantly shorter procedure and ablation times. Complication rates were 5.7% and 4.9% for PVAC Gold and ST-CF, respectively (P = 0.782). CONCLUSION: In this multicentre randomized clinical trial, ablation with ST-CF and PVAC Gold ablation catheters non-inferiority for efficacy was not met. AF recurrence was significantly more frequent in the PVAC Gold group compared to single-tip contact force group. Both groups had similarly low rates of adverse events. PVAC Gold ablation had significantly shorter procedure and ablation times.

Dielectric imaging for electrophysiology procedures: The technology, current state, and future potential.

Electroanatomic mapping systems have become an essential tool to guide the identification and ablation of arrhythmic substrate. Recently, a novel guiding system for electrophysiology procedures was introduced that uses dielectric sensing to perform high resolution anatomical imaging. Dielectric imaging systems use electrical fields to differentiate anatomic structures based on their conductivity and permittivity. This technique enables non-fluoroscopic, noncontact mapping of anatomic structures, assessment of pulmonary vein occlusion state during cryoballoon ablation, and has the potential to assess for additional tissue characterization including tissue thickness and tissue type. This article elaborates on the functioning and potential of dielectric imaging systems and provides two cases to illustrate the clinical impact for electrophysiology procedures.

[A poisonous spring smoothie with wild herbs: accidental intoxication with foxglove (Digitalis purpurea)]. / Een giftige lente-smoothie van wilde kruiden.

BACKGROUND: At a time when self-sufficiency and health are becoming increasingly important in society, the chances of intoxications with wild plants are increasing. Foxglove contains poisonous cardiac glycosides such as digoxin, digitoxin and gitoxin. The levels vary greatly and depend on the season and the location of the plants. The "non-digoxin" cardiac glycosides show a limited cross-reaction with the digoxin assay. This means that a low or therapeutic digoxin level does not rule out a severe foxglove intoxication. Due to the long half-life of the different cardiac glycosides, toxic symptoms can be persistent. CASE DESCRIPTION: A 43-year-old woman arrived at the Emergency Department with persistent vomiting and specific ECG-abnormalities. The day before, she drunk a smoothie made from wild plants picked in the woods. Patient appeared to have mistaken foxglove for common sorrel. CONCLUSION: In case of persistent gastrointestinal complaints with specific ECG abnormalities after ingestion of plant material, clinicians should be aware of a foxglove intoxication.

The WATCHMAN left atrial appendage closure device for patients with atrial fibrillation: current status and future perspectives.

INTRODUCTION: Atrial fibrillation (AF) is associated with an increased risk of stroke. Stroke prevention with oral anticoagulation (OAC) is recommended in AF patients at increased risk of stroke. The left atrial appendage (LAA) is the main source of thrombus formation in AF patients. The WATCHMAN percutaneous LAA closure (LAAC) device may serve as an alternative to OAC overcoming disadvantages including the risk of (major) bleeding. AREAS COVERED: This review will focus on LAAC with the Watchman device for stroke prevention in AF patients. Current status, available literature, clinical safety and efficacy will be summarized. Furthermore, the future perspectives of Watchman will be discussed. EXPERT OPINION: LAAC with Watchman appears a promising, safe, and effective alternative to OAC. Ongoing and future studies to consolidate the position of Watchman should focus on comparative safety and efficacy of different LAAC devices, patient selection, various post-procedural antithrombotic regimens, head-to-head comparisons with NOAC, better understanding of device-related thrombus, and the role of the LAA in the propagation of non-valvular AF. This research may attribute to a paradigm shift in which LAAC no longer serves as a 'last resort' treatment for AF patients ineligible for OAC but may serve as a second-line or even first-line treatment option for AF patients.