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Aims Remote monitoring (RM) is the standard of care for follow up of patients with cardiac implantable electronic devices. The aim of this study was to compare smartphone-based RM (SM-RM) using patient applications (myMerlinPulse™ app) with traditional bedside monitor RM (BM-RM). Methods and results The retrospective study included de-identified US patients who received either SM-RM or BM-RM capable of implantable cardioverter defibrillators or cardiac resynchronization therapy defibrillators (Abbott, USA). Patients in SM-RM and BM-RM groups were propensity-score matched on age and gender, device type, implant year, and month. Compliance with RM was quantified as the proportion of patients enrolling in the RM system (Merlin.net™) and transmitting data at least once. Connectivity was measured by the median number of days between consecutive transmissions per patient. Of the initial 9714 patients with SM-RM and 26 679 patients with BM-RM, 9397 patients from each group were matched. Remote monitoring compliance was higher in SM-RM; significantly more patients with SM-RM were enrolled in RM compared with BM-RM (94.4 vs. 85.0%, P < 0.001), similar number of patients in the SM-RM group paired their device (95.1 vs. 95.0%, P = 0.77), but more SM-RM patients transmitted at least once (98.1 vs. 94.3%, P < 0.001). Connectivity was significantly higher in the SM-RM, with patients transmitting data every 1.2 (1.1, 1.7) vs. every 1.7 (1.5, 2.0) days with BM-RM (P < 0.001) and remained better over time. Significantly more SM-RM patients utilized patient-initiated transmissions compared with BM-RM (55.6 vs. 28.1%, P < 0.001). Conclusion In this large real-world study, patients with SM-RM demonstrated improved compliance and connectivity compared with BM-RM.

The diagnosis of device infections, especially pocket infections, is challenging and relies primarily on clinical presentation. The prospective DIRT (Device associated Infections Role of new diagnostic Tools) study identified procalcitonin (PCT) as the most promising biomarker among other 14 biomarkers to aid the diagnosis of pocket infection. It also identified an optimized cut-off value of 0.05 ng/ml for a localized generator pocket infection.The present study aims to validate the proposed PCT cut-off value of 0.05 ng/ml for the diagnosis of pocket infection in an independent cohort.We prospectively enrolled 81 patients with pocket infections and 81 controls matched for age and renal function presenting for elective device exchange or lead revision. Patients with concomitant infectious or inflammatory diseases, end-stage renal failure, current active malignancy, or receiving immunosuppressive therapy were excluded.An elevated PCT over 0.05 ng/ml was found in 68% (n = 55) of pocket infections and 24% (n = 19) of controls, corresponding to a sensitivity of 68% and a specificity of 77% for diagnosing a pocket infection. In receiver operating characteristic (ROC) analysis, PCT showed an area under the curve of 0.75 (95% confidence interval, 0.68-0.83; P0.001). Sensitivity remained high with antibiotic pretreatment (65% compared to 69% without pretreatment) and in cases with minimal inflammatory signs (67% compared to 70% with extensive inflammation).Our study validates the cut-off value of 0.05 ng/ml PCT for diagnosis of a pocket infection, even in patients pre-treated with antibiotics or with minimal clinical signs of inflammation.

The rate of transvenous lead extraction (TLE) is increasing, with an increasing rate of complex devices being implanted. TLE is now a routine part of cardiac device management and up-to-date data on the safety and efficacy of TLE with modern tools and techniques is essential to management decisions regarding noninfectious indications for lead extraction. We present a contemporary, prospective review of TLE at our high-volume cardiac center. All patients who underwent TLE from June 2016 to June 2019 were enrolled in our local database, and baseline clinical data, procedural information, and outcome data were collected. In total, 561 leads were explanted (n = 153) or extracted (n = 408) from 341 patients over the study period. Patients were predominantly male (71%), with a mean age of 65 ± 17 years. The most common indication for lead removal was lead failure (45.2%, n = 154), followed by infection of the pocket or device (29.3%, n = 100). In total, complete success was achieved in 96.4% (n = 541) leads, clinical success in a further 2.1% (n = 12), and failure only in 1.4% (n = 8). There was an overall complication rate of 0.9% (3/341) for major complications and 1.5% (5/341) for minor complications. There were no deaths. In conclusion, our data suggest that there are ongoing improvements in the safety profile and success rates of lead extraction undertaken by experienced operators. The major complication rate now is1%.

Aims Battery electric vehicle (BEV) sales and use are rapidly expanding. Battery electric vehicles, along with their charging stations, are a potential source of electromagnetic interference (EMI) for patients with cardiac implantable electronic devices (CIEDs). The new ‘high-power’ charging stations have the potential to create strong electromagnetic fields and induce EMI in CIEDs, and their safety has not been evaluated. Methods and results A total of 130 CIED patients performed 561 charges of four BEVs and a test vehicle (350 kW charge capacity) using high-power charging stations under continuous 6-lead electrocardiogram monitoring. The charging cable was placed directly over the CIED, and devices were programmed to maximize the chance of EMI detection. Cardiac implantable electronic devices were re-interrogated after patients charged all BEVs and the test vehicle for evidence of EMI. There were no incidences of EMI, specifically no over-sensing, pacing inhibition, inappropriate tachycardia detection, mode switching, or spontaneous reprogramming. The risk of EMI on a patient-based analysis is 0/130 [95% confidence interval (CI) 0%–2%], and the risk of EMI on a charge-based analysis is 0/561 (95% CI 0%–0.6%). The effective magnetic field along the charging cable was 38.65 µT and at the charging station was 77.9 µT. Conclusions The use of electric cars with high-power chargers by patients with cardiac devices appears to be safe with no evidence of clinically relevant EMI. Reasonable caution, by minimizing the time spent in close proximity with the charging cables, is still advised as the occurrence of very rare events cannot be excluded from our results.

BACKGROUND: Patients with congenital heart defects (CHD) are prone to residua, sequels and complications from the underlying anomaly, where cardiac arrhythmias are one of the major causes for hospitalization, morbidity and mortality. The importance of the subcutaneous implantable loop recorder (ILR) for the detection and documentation of significant arrhythmias has increased over the last years. To date, however, there is little data on ILR use in the CHD population. METHODS: In this single center, retrospective observational study, all CHD-patients with an ILR were identified who were under care of the German Heart Center Munich between February 2015 and January 2019. The primary endpoint of the study was the detection or exclusion of significant arrhythmias during follow-up in CHD-patients who had received an ILR. The secondary endpoint was to determine whether ILR findings influenced patient management, defined as initiation or adjustment of medication, cardioversion, electrophysiologic study, catheter ablation, or implantation of cardiac implantable electronic devices (CIEDs) such as pacemakers (PM) or implantable cardioverter-defibrillators. RESULTS: An ILR was implanted in 33 CHD-patients (mean age, 43±20 years; 42.4% female) with CHD. During a mean observation period of 697±433 days, clinically relevant arrhythmias, correlating with the patients’ complaints and symptoms, were detected in 19 patients (59.4%), encompassing supraventricular tachycardia (n=10), supraventricular or ventricular ectopic beats (n=10), non-sustained ventricular tachycardia (n=2), ventricular tachycardia (n=2), and bradycardia (n=2). In 9 patients (28.1%) the detected arrhythmia was considered an event requiring treatment. Treatment modalities included catheter ablation (n=5), modification of antiarrhythmic drug regime (n=2), adaptation of anticoagulation therapy (n=2), or implantation of a subcutaneous ICD (n=1). Regarding the occurrence of cardiac arrhythmias or a related need for therapeutic intervention, no significant differences were identified with respect to WHO functional class, the presence of pulmonary arterial hypertension or reduced resting peripheral oxygen saturation. CONCLUSIONS: In symptomatic CHD-patients at risk for life-threatening cardiac events, ILR has a considerable complementary diagnostic value for the detection and differentiation of benign and malignant arrhythmias. Considering the overall low risk of complications, ILR implantation should be considered in patients with CHD of any complexity who need medium or long-term arrhythmia monitoring, especially if short-term Holter monitoring cannot provide sufficient diagnostic certainty.

BACKGROUND: Atrial fibrillation (AF) is associated with significant morbidity and is predicted by atrial high rate events. The early detection of AF is paramount to timely interventions to reduce the morbidity of AF. The DX ICD system combined with Home Monitoring® allows for continuous atrial rhythm monitoring without the need for a dedicated atrial lead. OBJECTIVE: To establish the reaction to and timing of reactions to the detection of atrial high rate episodes (AHRE). METHODS: A prospective cohort of DX ICD systems was followed up and the response to AHREs was collected and evaluated. RESULTS: A total of 234 patients were enrolled; an AHRE ⩾ 6 min was detected in 13.7% of patients (n= 32) within a mean follow-up duration of 16 months. A high rate of oral anticoagulation (OAC) prescription was seen with the detection of AHREs in patients with a not-low risk CHA2DS2-VASc score. There was a delay in this prescription highlighting the potential to improve the timeliness of patient care in this group of patients. CONCLUSIONS: The DX ICD system provides rapid and ongoing atrial rhythm monitoring such that physicians are rapidly aware of AHRE without the need for a dedicated atrial lead, but local protocols are needed to improve the response time of anti-coagulation prescription.

Background: Femoral vascular access using the standard anatomic landmark-guided method is often limited by peripheral artery disease and obesity. We investigated the effect of ultrasound-guided vascular puncture (UGVP) on the rate of vascular complications in patients undergoing catheter ablation for atrial or ventricular arrhythmias. Methods: The data of 479 patients (59% male, mean age 68 years ± 11 years) undergoing catheter ablation for left atrial (n = 426; 89%), right atrial (n = 28; 6%) or ventricular arrhythmias (n = 28; 6%) were analyzed. All patients were on uninterrupted oral anticoagulants and heparin was administered intravenously during the procedure. Femoral access complications were compared between patients undergoing UGVP (n = 320; 67%) and patients undergoing a conventional approach (n = 159; 33%). Complication rates were also compared between patients with a BMI of >30 kg/m2 (n = 136) and patients with a BMI < 30 kg/m2 (n = 343). Results: Total vascular access complications including mild hematomas were n = 37 (7.7%). In the conventional group n = 17 (10.7%) and in the ultrasound (US) group n = 20 (6.3%) total vascular access complications occurred (OR 0.557, 95% CI 0.283–1.096). UGVP significantly reduced the risk of hematoma > 5 cm (OR 0.382, 95% CI 0.148, 0.988) or pseudoaneurysm (OR 0.160, 95% CI 0.032, 0.804). There was no significant difference between the groups regarding retroperitoneal hematomas or AV fistulas (p > 0.05). In patients with BMI > 30 kg/m2, UGVP led to a highly relevant reduction in the risk of total vascular access complications (OR 0.138, 95% CI 0.027, 0.659), hematomas > 5 cm (OR 0.051, 95% CI 0.000, 0.466) and pseudoaneurysms (OR 0.051, 95% CI 0.000, 0.466). Conclusion: UGVP significantly reduces vascular access complications. Patients with a BMI > 30 kg/m2 seem to particularly profit from a UGVP approach.

AimsThis retrospective study sought to compare complication rates and efficacy of power-controlled very high-power short-duration (vHPSD) and conventional catheter ablation in a large cohort of patients with atrial fibrillation (AF).Methods and resultsWe analyzed 1115 consecutive patients with AF (38.7% paroxysmal, 61.3% persistent) who received first-time catheter ablation at our centre from 2015 to 2021. Circumferential pulmonary vein isolation ± additional substrate ablation using an irrigated-tip catheter was performed with vHPSD (70 W/5–7 s or 60 W/7–10 s) in 574 patients and with conventional power (30–35 W/15–30 s) in 541 patients. Baseline characteristics were well-balanced between groups (mean age 65.1 ± 11.2 years, 63.4% male). The 30-day incidence of cardiac tamponade [2/574 (0.35%) vs. 1/541 (0.18%), P = 0.598], pericardial effusion ≥ 10 mm [2/574 (0.35%) vs. 1/541 (0.18%), P = 0.598] and transient ischaemic attack [1/574 (0.17%) vs. 2/541 (0.37%), P = 0.529] was not significantly different between vHPSD and conventional ablation. No stroke, atrio-esophageal fistula, cardiac arrest or death occurred. Procedure (122.2 ± 46.8 min vs. 155.0 ± 50.5 min, P < 0.001), radiofrequency (22.4 ± 19.3 min vs. 52.9 ± 22.0 min, P < 0.001), and fluoroscopy (8.1 ± 7.2 vs. 9.2 ± 7.4, P = 0.016) duration were significantly shorter in the vHPSD group. At 12 months follow-up, freedom of any atrial arrhythmia was 44.1% vs. 34.2% (P = 0.010) in persistent AF and 78.1% vs. 70.2% in paroxysmal AF (P = 0.068).ConclusionvHPSD ablation is as safe as conventional ablation and is associated with an improved long-term efficacy in persistent AF.

This study was designed to evaluate the electromagnetic interference (EMI) effects and safety of the new security screening millimetre wave body scanners (MWBSs) for patients with rare cardiac implantable electronic devices (CIEDs). We identified 73 patients with either entirely subcutaneous implantable cardioverter-defibrillators (S-ICD) or leadless pacemakers (LPM) attending routine device follow-up. CIED programming was optimised for the detection of EMI occurrence, and high-voltage therapy was disabled. Patients then underwent millimetre wave body scans under continuous ECG monitoring. Scanning was performed at the recommended distance as well as in close proximity to the scanner emulating accidental exposure. CIED function was observed for EMI effects. There were no episodes of inhibition of pacing in the leadless pacemaker subgroup, no oversensing in the S-ICD subgroup and no spontaneous device reprogramming in any group. There was no change in pacing or sensing thresholds, and S-ICD vector eligibility remained unchanged after scanning with the MWBS. No CIEDs were identified by the MWBS during the study. No EMI events were detected during the use of MWBSs by patients with either S-ICDs or LPMs. This data should be reassuring for patients suggesting that they can undergo security body scans without worries or disclosure of their CIED status.

Background In paroxysmal atrial fibrillation (AF), pulmonary vein isolation using HPSD has shown a promising success rate compared to ablation using conventional power settings, as well as a significant reduction in procedural and ablation time. In persistent atrial fibrillation, left atrial substrate modification seems to be a promising additional ablation approach besides pulmonary vein isolation (PVI). However, results after additional substrate ablation are not consistently positive, which may be related to non-transmural lesions and tissue oedema. An extended time of the procedure may also influence safety. Recent publications showed that HPSD ablation provides more sufficient lesions due to acute cell necrosis instead of cell oedema. Purpose The aim of this study is to evaluate the safety of HPSD ablation in patients undergoing ablation of persistent atrial fibrillation with PVI and additional substrate modification. Methods We studied and compared n=300 patients from our register undergoing the first ablation of persistent atrial fibrillation with HPSD settings (n=150) between May 2018 and January 2019 and standard settings (n=150) between July 2017 and January 2018. Patients were followed up for three months to report procedure-related adverse events. In all patients, a modified stepwise approach using PVI followed by electrogram-guided substrate modification and linear-ablation, if necessary, was performed. A HPSD ablation was performed with 70 watts with a maximum duration of 5–7 seconds. Catheter irrigation was set to 20 ml/min using the Flexability™ ablation catheter and the Ampere™ generator. The patients were compared with a historical cohort that underwent PVI using a conventional power protocol with 30–40 watts over 20–40 seconds, using the same ablation catheter. A transthoracic echocardiogram was performed in all patients after the ablation-procedure and on the following day. Duplex sonography or clinical control were performed to assess groin complications. Results Baseline characteristics and procedural data are shown in table 1. No significant difference in the complication rates in both groups was observed by a significant procedure-time reduction in HPSD-Group (2:13h vs 2:31h p Conclusion Complex ablation using PVI and additional substrate modification in persistent atrial fibrillation using HPSD seems to be equally as safe regarding procedure-related outcomes as standard power settings ablation and can significantly reduce the time of the overall procedure. Funding Acknowledgement Type of funding sources: None.

Catheter ablation in adult congenital heart disease (ACHD) patients is a critical treatment strategy for complex arrhythmias including atrial fibrillation (AF) and atrial tachycardia (AT). In addition to vitamin K antagonists (VKAs), direct oral anticoagulants (DOACs) are increasingly used in this patient population.The purpose of this study was to assess the safety of catheter ablation in ACHD patients on uninterrupted oral anticoagulation with VKA or DOAC, examining thromboembolic, bleeding, and vascular access complications.Retrospective analysis of 234 ACHD patients with simple (n = 83), moderate (n = 66), or complex (n = 85) CHD (mean age 46 years) undergoing 368 ablation procedures on uninterrupted oral anticoagulation with VKA (45.4%) or DOAC (54.6%) was undertaken. Arrhythmias were AF in 97, right AT in 181, left AT in 65, or a combination of AF and AT in 25.No thromboembolic complications occurred. Major complications occurred in 4 patients (1.1%; 1 VKA, 3 DOAC), including retroperitoneal hematoma in 2 and arteriovenous (AV) fistula requiring surgical treatment in 2. Minor bleeding or vascular access complications occurred in 46 cases (12.5%), including hematomas5 cm in 26, AV fistulas (not requiring surgical intervention) in 13, and pseudoaneurysms in 7 (thrombin injection in 3/7). Overall, no significant difference was found between DOAC (14.9%) and VKA groups (12.0%; P = .411).Catheter ablation in ACHD patients on uninterrupted oral anticoagulation with VKA or DOAC is feasible and safe. No thromboembolic events occurred, and major bleeding or vascular access complications were rare. No significant differences regarding minor bleeding or vascular access complications between patients on DOAC or VKA were found.

Background High power short duration (HPSD) radiofrequency-ablation (RFA) is highly efficient and safe while reducing procedure and RF time in pulmonary vein isolation (PVI). The QDot-catheter is a novel contact-force ablation catheter that allows automated flow and power adjustments depending on the local tissue temperature to maintain a target temperature during 90watts/4seconds lesions. We analysed intraprocedural data and periprocedural safety using the QDot-catheter in patients undergoing PVI for paroxysmal atrial fibrillation (PAF). Methods We included n=48 patients undergoing PVI with the QDot-catheter with a temperature controlled HPSD ablation mode with 90watts/4seconds (TC-HPSD). If focal reconnection occurred besides repeat ablation the ablation mode was changed to 50watts/15seconds (QMode). N=23 patients underwent cerebral MRI to detect silent cerebral lesions. Results Mean RF-time was 8.1+/-2.8min, procedure-duration was 84.5+/-30min. The overall maximal measured catheter-tip temperature was 52.0°C +/- 4.6°C, mean overall applied current was 871mA +/-44mA and over all applied energy was 316J +/-47J. The mean local impedance-drop was 12.1 +/- 2.4 Ohms. During Adenosine challenge n=14 (29%) patients showed dormant conduction. A total of n=24 steam pops were detected in n=18 patients (39.1%), while no pericardial tamponade occurred. No periprocedural thromboembolic complications occurred, while n=4 patients (17.4%) showed silent cerebral lesion. Conclusion TC-HPSD ablation with 90watts/4seconds using the QDot-catheter led to a reduction of procedure and RF time, while no major complications occurred. Despite optimized temperature control and power adjustment steam pops occurred in a rather high number of patients, while none of them lead to tamponade or to clinical or neurological deficits.

Catheter ablation is an effective treatment for atrial fibrillation (AF). Obstructive sleep apnea (OSA) is a known risk factor for recurrent AF. The apnea-hypopnea index (AHI) is a measurement tool to screen patients for OSA. We sought to evaluate if the ambulatory assessed AHI is associated with AF recurrence following AF catheter ablation. 187 patients with paroxysmal (n = 155) or early persistent (n = 32) AF presenting for catheter ablation were included in the study. AHI was determined prior to ablation using an ambulatory screening device. All patients underwent pulmonary vein isolation (PVI). In patients with early persistent AF (17%) additional ablation of complex fractionated atrial electrograms (CFAE) was performed. Clinical follow-up was available after 3 and 12 months including 7-day Holter-ECG. All 187 patients (60.3 ± 11.4 years, 64.2% male) completed the 3 months follow-up and 170 patients the 12 months follow-up. A pathological AHI ≥15 was found in 45/187 (24.1%) patients. Additional CFAE did not differ between patients with an AHI ≥15 and AHI15 (p = 0.663). After 3 months, 12/41 (29.3%) patients with AHI ≥15 showed recurrent AF compared to 24/146 (16.4%) patients with AHI15 (p = 0.066). After 12 months, AHI ≥15 was associated with a significant higher rate of AF recurrence of 47.4% (18/38) versus 26.5% (35/132) in patients with AHI15 (p = 0.014). In the logistic regression analysis AHI ≥15 was an independent predictor of recurrent AF at 12 months (p = 0.011). In conclusion, ambulatory assessed AHI ≥15 is associated with increased risk for AF recurrence following catheter ablation. OSA screening should be performed in AF patients as it might influence catheter ablation success.

The prevalence of atrial fibrillation (AF) is significantly higher in adults with congenital heart disease (ACHD) compared to patients without congenital heart disease (CHD). As AF in ACHD patients might have significant hemodynamic consequences, rhythm control is particularly desirable but rarely achieved by antiarrhythmic drugs. The aim of this study was to investigate safety and long-term outcome of AF ablation in ACHD patients. All ACHD patients (n = 46) that underwent AF ablation at our centre from 2013 to 2017 were included in the study. CHD was classified as simple (46%), moderate (41%) or complex (13%). The majority of patients (61%) suffered from persistent AF (paroxysmal AF 39%). Persistent AF was present in 57% of patients with simple, in 58% of patients with moderate and 83% of patients with complex CHD. All patients underwent radiofrequency (RF) ablation on uninterrupted oral anticoagulation. Pulmonary vein isolation (PVI) was performed in patients with paroxysmal AF, whereas patients with persistent AF underwent PVI and ablation of complex fractionated atrial electrograms (CFAE). No major complications occurred. Single-procedure success after 18 months off antiarrhythmic drugs was 61% for paroxysmal AF and 29% for persistent AF (p = 0.003). Multiple procedures (mean 2.1 ± 1.4) increased long-term success to 82% for paroxysmal AF and 48% for persistent AF (p = 0.05). Long-term ablation success was 64% for simple, 62% for moderate and 50% for complex CHD patients. AF ablation in ACHD patients is feasible and safe regardless of CHD complexity. Success rates in patients with paroxysmal AF are high and comparable to patients without CHD. In ACHD patients with persistent AF, success rates of ablation are markedly reduced which might be due to a different and/or more extensive (bi-)atrial substrate. In the cohort of complex ACHD patients with persistent AF as the dominant AF type, long-term success of AF ablation is limited.

Therapy of choice for the primary and secondary prevention of sudden cardiac death is the implantation of an implantable cardioverter defibrillator (ICD). Whereas appropriate and inappropriate ICD shocks lead to myocardial microdamage, this is not known for antitachycardia pacing (ATP). In total, 150 ICD recipients (66 ± 12 years, 81.3% male, 93.3% primary prevention, 30.0% resynchronization therapy) were randomly assigned to an ICD implantation with or without intraoperative ATP. In the group with ATP, the pacing maneuver was performed twice, each time applying 8 impulses à 6 Volt x 1.0 milliseconds to the myocardium. High sensitive Troponin T (hsTnT) levels were determined prior to the implantation and thereafter. There was no significant difference in the release of hsTnT between the two randomization groups (delta TnT without ATP in median 0.010 ng/ml [min. −0.016 ng/ml–max. 0.075 ng/ml] vs. with ATP in median 0.013 ng/ml [min. −0.005–0.287 ng/ml], p = 0.323). Setting a hsTnT cutoff of 0.059 ng/dl as a regularly augmented postoperative hsTnT level, no relevant difference between the two groups regarding the postoperative hsTnT levels above this cutoff could be identified (without ATP n = 10 [14.7%] vs. with ATP n = 16 [21.9%], p = 0.287). There was no significant difference in the release of high sensitive Troponin between patients without intraoperative ATP compared to those with intraoperative ATP. Hence, antitachycardia pacing does not seem to cause significant myocardial microdamage. This may further support its use as a painless and efficient method to terminate ventricular tachycardia in high-risk patients.

Data about the safety of edoxaban in patients who underwent left atrial (LA) radiofrequency (RF) ablation procedures are lacking. This study sought to compare the safety of uninterrupted edoxaban with uninterrupted phenprocoumon administration during LA RF ablation for atrial fibrillation and atrial tachycardia. In total, 231 patients (mean age 64 ± 11years, male 71%) who underwent LA RF ablation under continuous oral anticoagulation (OAC) with edoxaban or phenprocoumon were included in the study. Patients on uninterrupted edoxaban (60 mg or 30 mg/day for at least 4 weeks) were matched for gender, age and type of arrhythmia with 2 patients on uninterrupted phenprocoumon (international normalized ratio 2 to 3). We identified 77 consecutive patients on edoxaban and n = 154 patients on phenprocoumon. Heparin was administered periprocedurally to achieve an activated clotting time of 280 to 300 seconds. No protamine was administered periprocedurally. The primary end point was a composite of bleeding, thromboembolic events, and death. The primary end point was met in 9 patients in the edoxaban group and in 22 patients in the phenprocoumon group (p = 0.69). No patient in either group died or had a thromboembolic complication. No major bleeding complication was observed in the edoxaban group, whereas one was found in 1 patient in the phenprocoumon group (p ≥0.99). Minor bleeding complications occurred in 9 patients (12%) in the edoxaban group and in 21 patients (14%) in the phenprocoumon group (p = 0.84). Uninterrupted OAC with edoxaban appeared to be as safe as uninterrupted OAC with phenprocoumon in patients who underwent LA RF ablation procedures.

Background Atrial fibrillation occurs frequently after open-heart surgery. It is associated with increased morbidity and mortality, longer hospital stays, and increased healthcare costs. Prophylactic administration of colchicine may mitigate post-operative atrial fibrillation (POAF). Methods We searched PubMed, ClinicalTrials.gov and CENTRAL databases to identify randomized controlled trials (RCTs) that; (1) compared prophylactic use of colchicine to placebo, or usual care, in patients with sinus rhythm who underwent elective open-heart surgery and (2) reported POAF-incidence. We excluded trials focused on incidence of atrial fibrillation after percutaneous interventions or colchicine treatment of diagnosed pericarditis or post-pericardiotomy-syndrome. A random-effects model was used to pool data for POAF-incidence as the primary outcome and for drug-related adverse effects, major adverse events (death and stroke), and hospital length-of-stay as secondary outcomes. Results We included five RCTs (1412 patients). Colchicine treatment reduced POAF-events by 30% versus placebo or usual care (18% vs. 27%, risk ratio (RR) 0.69, 95% confidence interval (CI) 0.57 to 0.84, p = 0.0002). Adverse drug-related effects, especially gastrointestinal intolerance, increased with colchicine; (21% vs. 8.2%, RR 2.52, 95% CI 1.62 to 3.93, p < 0.0001). However, major adverse events were unchanged (3.2% vs. 3.2%, RR 0.96, 95% CI 0.48 to 1.95, p = 0.92). Length-of-stay decreased by 1.2 days with colchicine (95% CI -1.89 to − 0.44, p = 0.002). Conclusion Colchicine demonstrated superior efficacy versus usual care for prevention of atrial fibrillation after cardiac surgery. Moreover, colchicine treatment was associated with shorter hospital stays. These benefits outweigh increased risk of adverse drug-related effects; although further work is needed to minimize gastrointestinal effects.

Aims Post-operative atrial fibrillation (POAF) occurs in 20-50% of patients amid post-operative stay after Cardiac Surgery. We intend to determine whether colchicine therapy in patients undergoing cardiac surgery is a cost-effective strategy for prevention of POAF. To undertake cost utility analysis and calculate incremental cost utility ratio (ICUR) for colchicine therapy in these subgroup of patients. Methods and results design Decision tree model to calculate the ICUR comparing two treatment strategies in patients undergoing cardiac surgery. One wherein patients received colchicine along with usual care and second where they received placebo or just usual care. Cost utility analysis was undertaken using relevant data from the systematic review and meta-analysis of the available randomized controlled trials till June 2016 and mean cost calculations from validated available sources across various jurisdictions. Results Colchicine treatment based on mean costs for life expectancy calculated at 10 years' post-surgery using recommended discounting rates of 3.5% was € 17544.80 cheaper per quality-adjusted life-year (QALY) gained. The incremental cost is negative and the incremental effect (QALY) is positive (South East quadrant), Hence the intervention of colchicine treatment is unequivocally cost-effective, meaning it is dominant and achieves better outcomes at a lower cost. Conclusion Our findings provide a benchmark for current and future analyses relating to effectiveness of colchicine on POAF events after cardiac surgery. Currently, there are few reports that provide cutting edge estimates of the higher expenses associated with POAF. Future analyses should likewise explore the impact of added costs from using pharmacologic efforts to prevent and treat POAF after cardiac surgery.

The aim of this study was to compare safety and feasibility of a subcutaneous purse-string suture (PSS) with manual compression (MC) to gain hemostasis in patients after multiple femoral venous punctures undergoing electrophysiological procedures on uninterrupted oral anticoagulation (OAK). A total of 784 patients who underwent catheter ablation for atrial fibrillation (n = 564) or (a)typical atrial flutter (n = 220) were assessed. Four hundred sixty-two patients received PSS (58.9%) and 322 patients (41.1%) received MC to gain hemostasis. All patients were on uninterrupted full-dose OAK. During the procedure, weight-adapted heparin was applied. Venous sheath diameter were 8Fr (n = 2)/11.5Fr (n = 1) for left atrial or 8Fr (n = 1)/6Fr (n = 2) for right atrial procedures. No protamine was administered at the end of the procedure. After PSS, patients' had 6 hours of bed rest compared with 10 hours after MC (sheath removal after 4 hours followed by a bandage for 6 hours). PSS was removed the following day. All patients underwent duplex sonography of the access site the following day. Using the PSS, hemostasis was achieved in 453 of 462 patients (98%). MC leads to hemostasis in all 322 patients. No difference was found between the 2 approaches regarding hematomas (5 cm or5 cm), arterio-venous fistulas, or pseudoaneurysms. No major complication such as ipsilateral leg ischemia, the need of vascular surgery, or deep vein thrombosis occurred. In conclusion, PSS is a safe and effective way to gain immediate hemostasis after multiple punctures of the femoral vein in patients undergoing catheter ablation on OAK. PSS avoids MC and leads to shorter patient immobilization.

There is a rising prevalence of patients with cardiac implantable electronic devices (CIEDs) as a result of an increasing implantation rate (worldwide >1 million/year), and many of these patients will undergo security screening for travel during their life ([1][1]). CIEDs are vulnerable to

Background Electric cars are increasingly used for public and private transportation and represent possible sources of electromagnetic interference (EMI). Potential implications for patients with cardiac implantable electronic devices (CIED) range from unnecessary driving restrictions to life-threatening device malfunction. This prospective, cross-sectional study was designed to assess the EMI risk of electric cars on CIED function. Methods One hundred and eight consecutive patients with CIEDs presenting for routine follow-up between May 2014 and January 2015 were enrolled in the study. The participants were exposed to electromagnetic fields generated by the four most common electric cars (Nissan Leaf, Tesla Model S, BMW i3, VW eUp) while roller-bench test-driving at Institute of Automotive Technology, Department of Mechanical Engineering, Technical University, Munich. The primary endpoint was any abnormalities in CIED function (e.g. oversensing with pacing-inhibition, inappropriate therapy or mode-switching) while driving or charging electric cars as assessed by electrocardiographic recordings and device interrogation. Results No change in device function or programming was seen in this cohort which is representative of contemporary CIED devices. The largest electromagnetic field detected was along the charging cable during high current charging (116.5 μT). The field strength in the cabin was lower (2.1-3.6 μT). Conclusions Electric cars produce electromagnetic fields; however, they did not affect CIED function or programming in our cohort. Driving and charging of electric cars is likely safe for patients with CIEDs.

To determine the current incidence of antitachycardia therapy suspension due to magnet reversion in patients with implantable cardioverter defibrillators (ICDs). From March 2012 to September 2018, all St. Jude Medical ICD interrogations performed at the Deutsches Herzzentrum Munchen were screened for stored events of antitachycardia therapy suspension caused by static magnetic fields (flux densities ≥ 1 mT as defined in St. Jude Medical ICDs) affecting the giant magnetoresistance (GMR) sensor. Intentional ICD deactivation or inappropriate magnet application in the hospital was classified as non-environmental electromagnetic interference (EMI) whereas in the case of any other stored magnet reversion, the event was classified as presumably environmental EMI. Data from 201 St. Jude Medical ICD patients (mean age 62 ± 24 years, 165 males/36 females) were included in the analysis. ICD interrogations occurred at a mean follow-up of 25.1 months ± 15.6 months and summed up to a total of 464 patient-years of follow-up. A total number of 43 magnet reversion events were detected in 21 patients. Thirty-two events in 13 patients were presumably related to environmental EMI sources. Suspension of antitachycardia therapy only occurred in a temporary fashion. None of the patients experienced any ventricular tachyarrhythmia during ICD inhibition. The incidence of antitachycardia therapy suspension due to magnet reversion related to presumably environmental EMI sources was 6.9% per patient and year. Although none of the patients experienced any harmful event, antitachycardia therapy suspension due to magnet reversion is a common issue. Patients should be well-educated about potential EMI sources as well as trained in handling them.

Die Schrittmacher- und Defibrillatortherapie ist als sichere Behandlung von bradykarden bzw. tachykarden Rhythmusstorungen etabliert. Trotz korrekter Sonden- und Geratefunktion sowie adaquater Programmierung konnen die Aggregate durch elektromagnetische Felder gestort werden. Im folgenden Artikel soll auf mogliche Storquellen mit sachlicher Risikobewertung und mogliche Vermeidungsstrategien hingewiesen werden. Die weit verbreiteten Sorgen hinsichtlich bedrohlicher Beeintrachtigungen der Implantate sollen genommen werden.

Patients with persistent atrial fibrillation (AF) may additionally suffer from a concealed sinus node disease. We sought to determine the incidence, indications and predictors of acute pacemaker [PM] implantation within 1 week after the ablation of persistent AF. We performed a retrospective analysis of patients, who had had an ablation of persistent AF at our center. Between 01/2011 and 08/2016, 1234 patients (mean age 65 ± 10 years, 66.7% male) without prior PM implantation underwent an ablation of persistent AF. Pulmonary vein isolation (PVI) was performed in 1158 (93.8%), the additional ablation of complex fractionated atrial electrograms (CFAE) in 1109 (89.9%) and linear ablation in 524 (42.5%) patients. Temporary cardiac pacing was necessary in 27 (2.2%) patients. The temporary PM was removed in 15 patients (1.2%) because sinus node recovered after a median of 1.0 (minimum 0.1−maximum 2.0) day. The remaining 12 (1.0%) patients required the implantation of a permanent PM. Another 13 (1.1%) patients required permanent PM implantation without prior temporary pacing. In a multivariable regression model, age [OR 1.07 (1.02–1.12), p = 0.006], sinus pauses prior to ablation [OR 7.97 (2.36–26.88), p = 0.001] and atria with low voltage [OR 2.83 (1.31–6.11), p = 0.008] were identified as significant predictors for acute cardiac pacing. Acute cardiac pacing within 1 week after the ablation of persistent AF was necessary in 40 (3.2%) patients. Age, sinus pauses in history prior to ablation and the existence of low-voltage areas in the atria were identified as relevant risk factors.

Fixation of the pacemaker leads during pacemaker implantation leads to an increase of cardiac Troponin T (cTnT) that can be interpreted as a sign of minimal myocardial damage. This trial evaluates whether the mechanism type of lead fixation influences the magnitude of cTnT release. Patients having a de-novo cardiac pacemaker implantation or a lead revision were centrally randomized to receive either a ventricular lead with an active (screw) or passive (tine) fixation mechanism. High-sensitive Troponin T (hsTnT) was determined on the day of the procedure beforehand and on the following day. 326 Patients (median age (IQR) 75.0 (69.0–80.0) years, 64% male) from six international centers were randomized to receive ventricular leads with an active (n = 166) or passive (n = 160) fixation mechanism. Median (IQR) hsTnT levels increased by 0.009 (0.004–0.021) ng/ml in the group receiving screw-in ventricular leads and by 0.008 (0.003–0.030) ng/ml in the group receiving tined ventricular leads (n.s.). In conclusion pacemaker implantations are followed by a release of hsTnT. The choice between active or passive fixation ventricular leads does not have a significant influence on the extent of myocardial injury and the magnitude of hsTnT release.

Cardiac resynchronization therapy (CRT) is standard of care in heart failure (HF), however this technique is associated with a non-responder rate of 30%. Multipole pacing (MPP) with a quadripolar lead may optimize CRT and responder rate by creating two electrical wave fronts in the left ventricular (LV) myocardium simultaneously in order to reduce mechanical dyssynchrony. The objective of this study was to investigate the acute impact of MPP on LV function by assessing systolic dyssynchrony index (SDI) and left ventricular ejection fraction (LVEF) via real-time three-dimensional echocardiography (RT3DE).In 41 consecutive patients (87.8% male; mean age 66.0 ± 12.7 years) who received CRT defibrillators with a quadripolar LV lead, RT3DE datasets were acquired the day after implantation under the following pacing configurations: Baseline AAI, conventional biventricular pacing using distal or proximal LV poles and MPP. Datasets were analyzed in paired samples evaluating SDI and LVEF depending on programmed pacing modality.MPP resulted in statistically significant reduction of SDI compared to baseline (6.3%; IQR 4.4-7.8 and 9.9%; IQR 8.0-12.7; p 0.001) and to conventional biventricular pacing using distal (7.6%; IQR 6.5-9.1; p 0.001) or proximal (7.4%; IQR 6.2-8.8; p 0.001) LV poles respectively. MPP yielded significant increase in LVEF compared to baseline (30.6%; IQR 25.8-37.5 and 27.2%; IQR 21.1-33.6; p 0.001) and to conventional biventricular pacing configuration with distal (28.1%; IQR 22.1-34.5; p 0.001) or proximal (28.6%; IQR 23.2-34.9; p 0.001) LV poles respectively.Multipole pacing improves mechanical dyssynchrony of the left ventricular myocardium as assessed by SDI and LVEF.

Purpose Electromagnetic interference (EMI) with implantable cardioverter defibrillators (ICDs) can cause oversensing and subsequently inappropriate ICD therapies. We retrospectively investigated the current incidence and clinical relevance of oversensing related EMI in a large cohort of ICD patients. Methods From January 2005 to April 2013, all ICD interrogations performed at our institution were analyzed for the occurrence of oversensing related EMI. EMI episodes were classified as clinically significant, potentially significant or of minor significance. To identify risk factors for EMI, we also analyzed different lead models in our cohort (integrated vs true bipolar leads). Results Data of 2940 ICD patients (mean age 63 ± 16 years, 2322 male patients, 7772 patient-years) were retrospectively analyzed for the occurrence of EMI. During the observation period, a total of 145 (hospital environment n = 97, non-hospital environment n = 48) episodes occurred and resulted in an overall EMI incidence, i.e. event rate, of 1.87 % per patient per year. Focusing on clinically significant or potentially significant episodes, the EMI incidence was 0.27 % per patient per year. Cox proportional hazards regression analysis did not reveal a statistically significant higher hazard of oversensing for patients with integrated bipolar leads compared to patients with true bipolar leads (HR = 2.21; 95 % CI 0.90-5.39; p = 0.083). Conclusions Our data demonstrate that EMI continues to occur in everyday life. Patients should be well informed about the potential sources and risks of EMI but they need not be overly concerned since the risk of EMI-especially in a non-hospital environment-is low.

Background The impact of right ventricular (RV) lead location on clinical end points in patients undergoing cardiac resynchronization therapy (CRT) is unclear. We evaluated the impact of different RV lead locations on clinical outcome in CRT patients enrolled in the Septal Positioning of ventricular implantable cardioverter-defibrillator (ICD) Electrodes (SPICE) trial, which randomized recipients of implantable cardioverter defibrillators to apical versus midseptal RV lead positioning. Methods Ninety-eight CRT recipients were included in the multicenter SPICE trial and followed for 12 months: Fifty-three patients were randomized to receive an apical (A) and 45 to receive a midseptal (S) lead position. We compared echocardiographical and electrocardiographical parameters and outcome. Results Echocardiographic response with respect to improvement of left ventricular ejection fraction (A: +15.8 ± 14.6%, S: +9.7 ± 12.6%, P = 0.156) and reduction of left ventricular end-diastolic diameter (A: −4.2 ± 10.7 mm, S: −7.5 ± 10.7 mm, P = 0.141) was comparable in apical and midseptal groups. Paced QRS width neither differed at prehospital discharge (A: 129 ± 21 ms, S: 135 ± 21 ms, P = 0.133) nor at 12-month follow-up (A: 131 ± 23 ms, S: 134 ± 28 ms, P = 0.620). No differences were found with respect to the risk of ventricular tachyarrhythmia or ICD therapy. Septal RV lead position, however, was associated with a significant longer time to a first heart failure event (P = 0.040) and a longer survival time (P = 0.019). Conclusions In CRT recipients, midseptal RV lead position was not superior with respect to improvement of echocardiographic parameters or paced QRS width. It did not predispose to ventricular arrhythmias or ICD therapy. The finding that midseptal lead position was associated with a longer time to first heart failure event and a longer survival time deserves further investigation.

Accuracy of Contact-Force SensingBackground Contact-force (CF) sensing catheters are increasingly used in clinical electrophysiological practice due to their efficacy and safety profile. As data about the accuracy of this technology are scarce, we sought to quantify accuracy based on in vitro experiments. Methods and Results A custom-made force sensor was constructed that allowed exact force reference measurements registered via a flexible membrane. A Smarttouch Surround Flow (ST SF) ablation catheter (Biosense Webster, Diamond Bar, CA, USA) was brought in contact with the membrane of the force sensor in order to compare the ST SF force measurements to force sensor reference measurements. ST SF force sensing technology is based on deflection registration between the distal and proximal catheter tip. The experiment was repeated for n = 10 ST SF catheters, which showed no significant difference in accuracy levels. A series of measurements (n = 1200) was carried out for different angles of force acting to the catheter tip (0°/perpendicular contact, 30°, 60°, 90°/parallel contact). The mean absolute differences between reference and ST SF measurements were 1.7 ± 1.8 g (0°), 1.6 ± 1.2 g (30°), 1.4 ± 1.3 g (60°), and 6.6 ± 5.9 g (90°). Measurement accuracy was significantly higher in non-parallel contact when compared with parallel contact (P < 0.01). Conclusions Catheter force measurements using the ST SF catheters show a high level of accuracy regarding differences to reference measurements and reproducibility. The reduced accuracy in measurements of 90° acting forces (parallel contact) might be clinically important when creating, for example, linear lesions.

Transseptal Puncture Guided by 3D-Fluoroscopy Background Transseptal puncture for left atrial (LA) access is still mainly performed using fluoroscopy and transesophageal or intracardiac echocardiography. We present an easily applicable approach for the guidance of transseptal puncture that uses the combination of a 3D-mapping system and CT-derived 3D-overlayed anatomy. Methods and Results A computer tomographic (CT) LA-angiography was performed in n = 65 patients prior to a scheduled atrial fibrillation ablation procedure. The CARTO3® (Biosense Webster, Diamond Bar, CA, USA) segmentation tool was used to create a 3D-reconstruction of cardiac anatomy and the spine. The CARTO UNIVU® module was then used to overlay and register the segmented 3D-anatomy onto fluoroscopy. The 3D-reconstructed spine and cardiac anatomy were congruently aligned to their fluoroscopic counterparts in fluoroscopic views. The feasibility of the technique, its safety, and accuracy (assessed as contour offsets between 3D-overlay and angiographic LA anatomy) were evaluated. Overlay registration accuracy was analyzed by CARTO3® registration matrices. Transseptal puncture was feasible without complications in all 65 patients using the new 3D-overlay technique. Three-dimensional-overlay contour offsets were 1.6 ± 1.2 mm in left PV, 1.7 ± 1.2 mm in right PV, and 1.3 ± 1.0 mm in the LA roof region. Overlay registration accuracy was 4.9 ± 2.7 mm. The average time needed for anatomy segmentation was 204 ± 61 seconds, time needed for overlay registration was 18 ± 8 seconds. Conclusions Three-dimensional-augmented fluoroscopy is feasible, safe, and easy to apply as guidance for transseptal puncture and demonstrates a high level of accuracy.

Aims This study presents and evaluates the impact of a new lowest-dose fluoroscopy protocol (Siemens AG), especially designed for electrophysiology (EP) procedures, on X-ray dose levels. Methods and results From October 2014 to March 2015, 140 patients underwent an EP study on an Artis zee angiography system. The standard low-dose protocol was operated at 23 nGy (fluoroscopy) and at 120 nGy (cine-loop), the new lowest-dose protocol was operated at 8 nGy (fluoroscopy) and at 36 nGy (cine-loop). Procedural data, X-ray times, and doses were analysed in 100 complex left atrial and in 40 standard EP procedures. The resulting dose–area products were 877.9 ± 624.7 µGym² ( n = 50 complex procedures, standard low dose), 199 ± 159.6 µGym² ( n = 50 complex procedures, lowest dose), 387.7 ± 36.0 µGym² ( n = 20 standard procedures, standard low dose), and 90.7 ± 62.3 µGym² ( n = 20 standard procedures, lowest dose), P < 0.01. In the low-dose and lowest-dose groups, procedure times were 132.6 ± 35.7 vs. 126.7 ± 34.7 min ( P = 0.40, complex procedures) and 72.3 ± 20.9 vs. 85.2 ± 44.1 min ( P = 0.24, standard procedures), radiofrequency (RF) times were 53.8 ± 26.1 vs. 50.4 ± 29.4 min ( P = 0.54, complex procedures) and 10.1 ± 9.9 vs. 12.2 ± 14.7 min ( P = 0.60, standard procedures). One complication occurred in the standard low-dose and lowest-dose groups ( P = 1.0). Conclusion The new lowest-dose imaging protocol reduces X-ray dose levels by 77% compared with the currently available standard low-dose protocol. From an operator standpoint, lowest X-ray dose levels create a different, reduced image quality. The new image quality did not significantly affect procedure or RF times and did not result in higher complication rates. Regarding radiological protection, operating at lowest-dose settings should become standard in EP procedures.