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1.
J Interv Card Electrophysiol ; 61(3): 603-607, 2021 Sep.
Article in English | MEDLINE | ID: mdl-32860605

ABSTRACT

PURPOSE: 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). METHODS: 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. RESULTS: 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. CONCLUSION: 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.


Subject(s)
Defibrillators, Implantable , Pacemaker, Artificial , Electrocardiography , Humans , Subcutaneous Tissue
2.
Indian Pacing Electrophysiol J ; 21(1): 14-17, 2021.
Article in English | MEDLINE | ID: mdl-33212244

ABSTRACT

AIM: To evaluate whether left bundle branch block with residual conduction (rLBBB) is associated with worse outcomes after cardiac resynchronisation therapy (CRT). METHODS: All consecutive CRT implants at our institution between 2006 and 2013 were identified from our local device registry. Pre- and post-implant patient specific data were extracted from clinical records. RESULTS: A total of 690 CRT implants were identified during the study period. Prior to CRT, 52.2% of patients had true left bundle branch block (LBBB), 19.1% a pacing-induced LBBB (pLBBB), 11.2% a rLBBB, 0.8% a right bundle branch block (RBBB), and 16.5% had a nonspecific intraventricular conduction delay (IVCD) electrocardiogram pattern. Mean age at implant was 67.5 years (standard deviation [SD] = 10.6), mean left ventricular ejection fraction (LV EF) was 25.7% (SD = 7.9%), and mean QRS duration was 158.4 ms (SD = 32 ms). After CRT, QRS duration was significantly reduced in the LBBB (p < 0.001), pLBBB (p < 0.001), rLBBB (p < 0.001), RBBB (p = 0.04), and IVCD groups (p = 0.03). LV EF significantly improved in the LBBB (p < 0.001), rLBBB (p = 0.002), and pLBBB (p < 0.001) groups, but the RBBB and IVCD groups showed no improvement. There was no significant difference in mortality between the LBBB and rLBBB groups. LV EF post-CRT, chronic kidney disease, hyperkalaemia, hypernatremia, and age at implant were significant predictors of mortality. CONCLUSION: CRT in patients with rLBBB results in improved LV EF and similar mortality rates to CRT patients with complete LBBB. Predictors of mortality post-CRT include post-CRT LV EF, presence of CKD, hyperkalaemia, hypernatremia, and older age at implant.

3.
Pacing Clin Electrophysiol ; 43(10): 1156-1164, 2020 10.
Article in English | MEDLINE | ID: mdl-32895960

ABSTRACT

AIMS: The aim of this retrospective cohort study was to assess the influence of early recurrence (ER) after pulmonary vein isolation (PVI) for paroxysmal atrial fibrillation (AF) on long-term outcomes and to identify clinical variables associated with ER. METHODS: We retrospectively collected clinical and procedural data from 1285 patients with paroxysmal AF who underwent PVI from 2011 to 2016. Kaplan-Meier, receiver operating characteristic (ROC) curve, logistic and Cox regression analyses were performed to analyze the influence of ER on long-term outcomes. RESULTS: ER was observed in 13% of patients. Kaplan-Meier analyses showed significantly different outcomes in 1285 patients with and without ER (49% vs 74%, log rank P < .01) and in 286 patients in the subgroup that underwent reablation (44% vs 79%, log rank P < .01). The hazard ratio (HR) of ER was 1.7 within 48 hours (5% of patients), 2.7 within 1 month (5%), 3.0 within 2 months (2%), and 6.4 within 3 months (1%) for late recurrence (LR), P < .01. ROC analysis (area under the curve [AUC] = 0.79) resulted in 70.3% sensitivity and 74.2% specificity for a 14-day blanking period, and 53.1% sensitivity and 85.5% specificity for a 30-day blanking period. Female patients (odds ratio [OR] 1.69, P < .01) and those with diabetes (OR 1.95, P = .01) were at higher risk for ER. CONCLUSIONS: ER is observed in a substantial number of patients with paroxysmal AF after PVI and has a continuous direct effect on LR according to the timing of ER. Randomized trials are required to assess the safety and effects of reablations in a shortened blanking period on long-term outcomes.


Subject(s)
Atrial Fibrillation/surgery , Catheter Ablation/methods , Pulmonary Veins/surgery , Aged , Female , Humans , Male , Middle Aged , Recurrence , Retrospective Studies , Risk Factors , Sensitivity and Specificity
4.
Sci Rep ; 10(1): 4753, 2020 03 16.
Article in English | MEDLINE | ID: mdl-32179792

ABSTRACT

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.


Subject(s)
Cardiac Pacing, Artificial/adverse effects , Cardiac Pacing, Artificial/methods , Death, Sudden, Cardiac/prevention & control , Defibrillators, Implantable , Intraoperative Care/adverse effects , Tachycardia, Ventricular/therapy , Aged , Biomarkers/blood , Cardiomyopathies/diagnosis , Cardiomyopathies/etiology , Defibrillators, Implantable/adverse effects , Female , Humans , Male , Middle Aged , Prospective Studies , Troponin T/blood
6.
Clin Res Cardiol ; 109(7): 904-910, 2020 Jul.
Article in English | MEDLINE | ID: mdl-31894385

ABSTRACT

BACKGROUND: 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. METHODS: 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). RESULTS: 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. CONCLUSIONS: 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.


Subject(s)
Anticoagulants/therapeutic use , Atrial Fibrillation/therapy , Catheter Ablation , Heart Defects, Congenital/complications , Administration, Oral , Adult , Aged , Anti-Arrhythmia Agents/therapeutic use , Atrial Fibrillation/complications , Drug Administration Schedule , Female , Humans , Male , Middle Aged , Retrospective Studies , Time Factors , Treatment Outcome
7.
Europace ; 22(3): 388-393, 2020 03 01.
Article in English | MEDLINE | ID: mdl-31872249

ABSTRACT

AIMS: Pulmonary vein isolation (PVI) using radiofrequency ablation (RFA) in patients with paroxysmal atrial fibrillation (PAF) is effective but hampered by pulmonary vein reconnection due to insufficient ablation lesions. High-power delivery over a short period of time (HPSD) in RFA is stated to create more efficient lesions. The aim of this study was to compare intraprocedural safety and outcome of HPSD ablation to conventional power settings in patients undergoing PVI for PAF. METHODS AND RESULTS: We included 197 patients with PAF that were scheduled for PVI. An ablation protocol with 70 W and a duration cut-off of 7 s at the anterior left atrium (LA) and 5 s at the posterior LA (HPSD group; n = 97) was compared to a conventional power protocol with 30-40 W for 20-40 s (standard group; n = 100) in terms of periprocedural complications and a 1-year outcome. The HPSD group showed significantly less arrhythmia recurrence during 1-year follow-up with 83.1% of patients free from atrial fibrillation compared to 65.1% in the standard group (P < 0.013). No pericardial tamponade, periprocedural thromboembolic complications, or atrio-oesophageal fistula occurred in either group. Mean radiofrequency time (12.4 ± 3.4 min vs. 35.6 ± 12.1 min) and procedural time (89.5 ± 23.9 min vs. 111.15 ± 27.9 min) were significantly shorter in the HPSD group compared to the standard group (both P < 0.001). CONCLUSION: High-power short-duration ablation demonstrated a comparable safety profile to conventional ablation. High-power short-duration ablation using 70 W for 5-7 s leads to significantly less arrhythmia recurrences after 1 year. Radiofrequency and procedural time were significantly shortened.


Subject(s)
Atrial Fibrillation , Catheter Ablation , Pulmonary Veins , Atrial Fibrillation/diagnosis , Atrial Fibrillation/surgery , Catheter Ablation/adverse effects , Catheter Ablation/methods , Heart Atria , Humans , Pulmonary Veins/surgery , Recurrence , Treatment Outcome
8.
Technol Health Care ; 28(1): 1-12, 2020.
Article in English | MEDLINE | ID: mdl-31744037

ABSTRACT

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.


Subject(s)
Automobiles , Defibrillators, Implantable , Electromagnetic Fields , Pacemaker, Artificial , Adult , Aged , Cross-Sectional Studies , Female , Humans , Male , Middle Aged , Prospective Studies
9.
J Interv Card Electrophysiol ; 56(3): 335-339, 2019 Dec.
Article in English | MEDLINE | ID: mdl-31617041

ABSTRACT

PURPOSE: To determine the current incidence of antitachycardia therapy suspension due to magnet reversion in patients with implantable cardioverter defibrillators (ICDs). METHODS: From March 2012 to September 2018, all St. Jude Medical ICD interrogations performed at the Deutsches Herzzentrum München 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. RESULTS: 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. CONCLUSION: 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.


Subject(s)
Defibrillators, Implantable , Electromagnetic Fields/adverse effects , Equipment Failure Analysis , Female , Humans , Male , Middle Aged , Risk Factors
10.
Clin Res Cardiol ; 108(2): 150-156, 2019 Feb.
Article in English | MEDLINE | ID: mdl-30051177

ABSTRACT

OBJECTIVES: Thromboembolic complications during atrial fibrillation (AF) ablation due to mobilisation of a pre-existing thrombus formation (TF) in the left atrium (LA) are devastating. The gold standard to exclude LA TF is transesophageal echocardiography (TEE). The present study compares sensitivity and specificity of a dual-source cardiac-computed tomography (DS-CT) with TEE for TF exclusion prior to AF ablation. In addition, CT protocols with and without ECG synchronized were evaluated. METHODS: In 622 patients, DS-CT as well as TEE to exclude TF was performed less than 48 h prior to AF ablation. Mean age of patients was 60 ± 10 years (69% males, 61% paroxysmal AF). During DS-CT, 280 patients (45%) were in AF. An ECG-synchronized DS-CT was performed in 332 patients, whereas 290 patients underwent DS-CT without ECG synchronization. RESULTS: In all patients without suspected TF on DS-CT (n = 552; 88.7%), no thrombus was found on TEE. A TF was suspected on DS-CT in 70 patients, of whom only three patients showed TF on TEE. No TF was detected in the other 67 patients (Fig. 1). Overall, sensitivity for TF detection in DS-CT was 100% and specificity was 89.2% (positive predictive value 4.3%, negative predictive value 100%). The CT protocol (ECG-synchronized versus non-ECG-synchronized) had no significant influence on diagnostic accuracy. Mean dose length product during DS CT was 282 ± 287 mGy cm (synchronized) versus 136 ± 55 mGy cm (non-synchronized) with p < 0.0001. CONCLUSIONS: DS-CT is a highly sensitive method for LA thrombus detection in patients undergoing AF ablation. It delivers additional anatomic details of pulmonary veins and LA anatomy with an acceptable radiation exposure. Non-ECG-synchronized DS-CT showed a significantly lower radiation exposure, whereas diagnostic accuracy was comparable. Therefore, DS-CT might serve as primary method to exclude LA TF in patients undergoing AF ablation.


Subject(s)
Atrial Fibrillation/surgery , Catheter Ablation/methods , Heart Diseases/diagnosis , Multidetector Computed Tomography/methods , Thrombosis/diagnosis , Atrial Fibrillation/complications , Atrial Fibrillation/diagnosis , Echocardiography, Transesophageal , Female , Heart Atria/diagnostic imaging , Heart Diseases/etiology , Humans , Male , Middle Aged , Preoperative Period , Prospective Studies , Reproducibility of Results , Thrombosis/etiology
11.
Clin Res Cardiol ; 108(6): 651-659, 2019 Jun.
Article in English | MEDLINE | ID: mdl-30460479

ABSTRACT

INTRODUCTION: 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. METHODS AND RESULTS: 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. CONCLUSION: 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.


Subject(s)
Atrial Fibrillation/surgery , Cardiac Pacing, Artificial , Catheter Ablation , Pacemaker, Artificial , Sick Sinus Syndrome/therapy , Aged , Atrial Fibrillation/diagnosis , Atrial Fibrillation/epidemiology , Atrial Fibrillation/physiopathology , Catheter Ablation/adverse effects , Female , Germany/epidemiology , Humans , Incidence , Male , Middle Aged , Retrospective Studies , Risk Assessment , Risk Factors , Sick Sinus Syndrome/diagnosis , Sick Sinus Syndrome/epidemiology , Sick Sinus Syndrome/physiopathology , Time Factors , Treatment Outcome
12.
Biomed Res Int ; 2018: 3417643, 2018.
Article in English | MEDLINE | ID: mdl-30186856

ABSTRACT

Atrial fibrillation (AF) is a relevant comorbidity in recipients of implantable cardioverter-defibrillators (ICD). Latest generation single-chamber ICD allow the additional sensing of atrial tachyarrhythmias and, therefore, contribute to the early detection and treatment of AF, potentially preventing AF-related stroke. The present study aimed to measure the impact on patient-related costs of this new ICD compared to conventional ICD. A Markov model was developed to simulate the long-term incidence of stroke in patients treated with a single-chamber ICD with or without atrial sensing capabilities. The median annual cost per patient and its difference, the number of strokes avoided, and the cost per stroke avoided were estimated. During a 9-year horizon, the costs for the ICD and stroke treatment were €570 per patient-year for an ICD with atrial sensing capabilities and €491 per patient-year for a conventional ICD. Per 1,000 patients, 4.6 strokes per year are assumed to be avoided by the new device. Higher CHA2DS2-VASc scores are associated with higher numbers of avoided strokes and larger potential for cost savings. Apart from clinical advantages, the use of ICD with atrial sensing capabilities may reduce the incidence of stroke and, in high-risk patients, may also contribute to reduce overall health care costs.


Subject(s)
Atrial Fibrillation/economics , Cost Savings , Atrial Fibrillation/complications , Atrial Fibrillation/diagnosis , Defibrillators, Implantable , Female , Heart Atria , Humans , Male , Markov Chains , Stroke/etiology , Stroke/prevention & control
14.
Sci Rep ; 8(1): 4870, 2018 03 20.
Article in English | MEDLINE | ID: mdl-29559697

ABSTRACT

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.


Subject(s)
Cardiac Surgical Procedures/instrumentation , Cardiac Surgical Procedures/methods , Electrodes, Implanted/adverse effects , Pacemaker, Artificial/adverse effects , Aged , Aged, 80 and over , Humans , Male , Middle Aged , Myocardium/pathology , Random Allocation , Troponin T/metabolism
15.
Am J Cardiol ; 121(4): 445-449, 2018 02 15.
Article in English | MEDLINE | ID: mdl-29289359

ABSTRACT

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.


Subject(s)
Anticoagulants/administration & dosage , Atrial Fibrillation/surgery , Factor Xa Inhibitors/administration & dosage , Phenprocoumon/administration & dosage , Pyridines/administration & dosage , Radiofrequency Ablation , Thiazoles/administration & dosage , Aged , Atrial Fibrillation/diagnostic imaging , Electrocardiography , Female , Humans , International Normalized Ratio , Male , Middle Aged , Pulmonary Veins/surgery , Treatment Outcome
16.
J Cardiovasc Electrophysiol ; 29(2): 330-334, 2018 02.
Article in English | MEDLINE | ID: mdl-29149500

ABSTRACT

INTRODUCTION: For radiofrequency (RF) ablation, the EP Shuttle® (Stockert GmbH, Freiburg, Germany), Ampere® (St. Jude Medical, St. Paul, MN, USA), and SmartAblate® (Biosense Webster, Diamond Bar, CA, USA) generator models are most frequently used in clinical practice. The aim of this study was to assess the correlation between selected and delivered RF power for different generators. METHODS AND RESULTS: In an experimental setup, ablation catheters were connected to the EP Shuttle® , Ampere® , and SmartAblate® generators. The power delivered by the generators was measured using a current converter and an oscilloscope. The selected power displayed on the generator was compared to the actually delivered power measured by the experimental setup (n = 800 measurements). The offsets between selected and delivered power increased significantly with impedance (EP Shuttle® ). For example, at a selected power of 30 W, the delivered power was 40.3 W (EP Shuttle® ), 30.1 W (Ampere® ), and 28.1 W (SmartAblate® ) at an impedance of 200 Ω. In addition, ablation lesions (n = 80) were created in ex vivo porcine cardiac muscle preparations. The resulting ablation lesion size was calculated in caliper measurements. When the EP Shuttle® generator was operated at 200 Ω, the resulting lesion size was significantly larger than at 100 Ω. There were no significant offsets between power delivery and lesion size when using the Ampere® or SmartAblate® generators. CONCLUSIONS: The Ampere® and SmartAblate® generator models deliver accurate power as selected by the user. The power delivered by the EP Shuttle® generator exceeds the selected power by up to 40% depending on impedance. The findings were confirmed in ex vivo porcine heart experiments and should be considered in clinical practice.


Subject(s)
Catheter Ablation/instrumentation , Electric Power Supplies , Animals , Cardiac Catheters , Electric Impedance , Equipment Design , Materials Testing , Models, Animal , Sus scrofa , Time Factors
17.
J Interv Card Electrophysiol ; 50(3): 203-209, 2017 Dec.
Article in English | MEDLINE | ID: mdl-29177982

ABSTRACT

PURPOSE: In some patients, both an electrophysiological examination (EPS) and a coronary angiography (CA) are necessary. It might be preferable to choose a combined approach of EPS and CA versus performing them consecutively. The purpose of this study is to evaluate the type and rate of adverse events between both approaches. METHODS: Patients were eligible if they underwent a CA and an EPS in a combined approach or in a time interval of at most 2 months. In all patients, clinical adverse events were recorded. RESULTS: A total of 1184 patients were included. CA and EPS were performed in a combined procedure (comb) in 492 patients, whereas they were performed consecutively in 692 patients (cons). The acute major complication rate was 0.67%, showing no differences between both groups. In the comb 6.9% and in the cons 6.6% of vascular complications were observed (p = 0.20). The rates of AV fistula and hematoma needing transfusion showed a significantly higher rate in the cons group (p = 0.018 and p = 0.045, respectively). In a multivariate logistic regression analysis, age was a significant predictor for groin complications. After propensity matching, AV fistula occurred significantly more often in the cons group (p = 0.002). CONCLUSION: Overall, serious adverse events were rare and there were no differences between the combined approach of EPS and CA and the consecutive approach; however, the occurrence of AV fistula and groin hematoma needing transfusion occurred significantly less in the combined procedure group. Therefore, a combined approach is preferable to a consecutive one.


Subject(s)
Cardiovascular Diseases/diagnostic imaging , Coronary Angiography/adverse effects , Electrophysiologic Techniques, Cardiac/adverse effects , Hematoma/etiology , Vascular Fistula/etiology , Aged , Cardiovascular Diseases/mortality , Cohort Studies , Coronary Angiography/methods , Electrophysiologic Techniques, Cardiac/methods , Female , Follow-Up Studies , Hematoma/epidemiology , Humans , Logistic Models , Male , Middle Aged , Multimodal Imaging/methods , Patient Selection , Propensity Score , Retrospective Studies , Risk Assessment , Sensitivity and Specificity , Survival Rate , Vascular Fistula/epidemiology , Vascular Fistula/physiopathology
18.
Pacing Clin Electrophysiol ; 40(10): 1167-1172, 2017 Oct.
Article in English | MEDLINE | ID: mdl-28861898

ABSTRACT

BACKGROUND: Catheter ablation of right-sided accessory pathways (APs) has lower success and higher recurrence rates compared to left-sided substrates. Irrigated-tip catheter (ITC) ablation might offer an advantage in this setting but data about its use in patients below 18 years are scarce. The aim of this study was to compare an ITC approach to conventional catheter ablation. METHODS: A retrospective analysis of all patients <18 years undergoing radiofrequency ablation (RFA) for right-sided APs from 2004 to 2014 at our institution was performed. Patients either underwent an ITC approach in combination with 3-D mapping (Group 1; n  =  53) or a conventional non-ITC approach (Group 2; n  =  52). Study endpoints were acute procedural success, safety, and recurrence rate. A total of 105 mostly adolescent patients (56.2% male; median age 14 years) with 107 right-sided APs were included. RESULTS: The prevailing anatomic AP locations were right posteroseptal (44.9%), right anterior/anterolateral (24.3%), and right lateral (13.1%). Acute success (94.3% vs 94.2%) did not differ between the groups. One major complication (pericardial effusion) occurred in the non-ITC group. Overall, freedom from AP recurrence was 94% at 4 years in the ITC group, and 81% at 4 years in the non-ITC group (P  =  0.04). CONCLUSIONS: The use of ITCs in combination with 3-D mapping system for ablation of right-sided APs in adolescents has a high acute success rate, is safe, and associated with a significantly reduced recurrence rate compared to a non-ITC/conventional approach. It might be considered as alternative approach in this age group.


Subject(s)
Accessory Atrioventricular Bundle/surgery , Catheter Ablation/instrumentation , Adolescent , Child , Child, Preschool , Equipment Design , Female , Humans , Male , Retrospective Studies
19.
J Cardiovasc Electrophysiol ; 28(12): 1415-1422, 2017 Dec.
Article in English | MEDLINE | ID: mdl-28800176

ABSTRACT

BACKGROUND: Ablation of atrial fibrillation (AF) on uninterrupted phenprocoumon reduces periprocedural thromboembolic and bleeding complications. Heparin is administered intraprocedurally to achieve activated clotting times (ACT) of 300-400 seconds. We investigated the effect of international normalized ratio (INR) on ACT and intraprocedural heparin requirements. Moreover, safety of a target ACT of 250-300 seconds was investigated. METHODS AND RESULTS: We studied 949 patients referred for AF or left atrial tachycardia ablation. Patients were divided into Group 1 (n = 249) with an INR <2 and Group 2 (n = 700) with an INR ≥2. Mean INR was 1.7 ± 0.13 in Group 1 and 2.3 ± 0.25 in Group 2. Baseline, mean, minimum and maximum ACT were significantly lower in Group 1 (138 ± 17 seconds vs. 145 ± 21 seconds; 281 ± 28 seconds vs. 288 ± 29 seconds; 251 ± 36 seconds vs. 258 ± 34 seconds; 307 ± 32 seconds vs. 316 ± 40 seconds; P <0.05). Intraprocedural heparin requirements adjusted to body weight were lower in Group 1 (127 ± 41 U/kg vs. 122 ± 40 U/kg). Weak correlations between INR and baseline, mean, minimum and maximum ACT as well as intraprocedural heparin requirements were observed. No differences regarding major or minor complications were found. INR and periprocedural anticoagulation parameters had no influence on major complications. No thromboembolic complications were observed in both groups with a target ACT value of 250-300 seconds. CONCLUSIONS: There is only a weak correlation between INR, intraprocedural ACT, and intraprocedural heparin requirements. Periprocedural target ACT of 250-300 seconds seems safe and does not increase periprocedural bleeding and thromboembolic complications in patients undergoing RF ablation on uninterrupted phenprocoumon therapy.


Subject(s)
Anticoagulants/administration & dosage , Atrial Fibrillation/surgery , Catheter Ablation/adverse effects , International Normalized Ratio/trends , Postoperative Complications/etiology , Vitamin K/antagonists & inhibitors , Administration, Oral , Aged , Atrial Fibrillation/diet therapy , Atrial Fibrillation/physiopathology , Blood Coagulation/drug effects , Blood Coagulation/physiology , Catheter Ablation/trends , Electrocardiography/drug effects , Electrocardiography/trends , Female , Follow-Up Studies , Heart Atria/physiopathology , Heart Atria/surgery , Hemorrhage/chemically induced , Hemorrhage/etiology , Humans , Male , Middle Aged , Postoperative Complications/chemically induced , Postoperative Complications/physiopathology , Retrospective Studies
20.
Clin Res Cardiol ; 106(12): 947-952, 2017 Dec.
Article in English | MEDLINE | ID: mdl-28849269

ABSTRACT

BACKGROUND: Remote magnetic navigation (RMN) is attributed to diminish radiation exposure for both patient and operator performing catheter ablation for different arrhythmia substrates. The purpose of this prospective, randomized study was to compare RMN with manually guided catheter ablation for AV nodal reentrant tachycardia (AVNRT) regarding fluoroscopy time/dosage, acute and long-term efficacy as well as safety. METHODS AND RESULTS: A total of 218 patients with AVNRT undergoing catheter ablation at three centers (male 34%, mean age 50 ± 17 years) were randomized to a manual approach (n = 113) or RMN (n = 105) using the Niobe® magnetic navigation system. The primary study endpoint was total fluoroscopy time/dosage for patient and operator at the end of the procedure. Secondary endpoints included acute success, procedure duration, complications and success rate after 6 months. Fluoroscopy time and dosage for the patient were significantly reduced in the RMN group compared to the manual group (6 ± 6 vs. 11 ± 10 min; p < 0.001 and 425 ± 558 vs. 751 ± 900 cGycm2, p = 0.002). A reduction in fluoroscopy time/dose also applied to the operator (3 ± 5 vs. 7 ± 9 min 209 ± 444 vs. 482 ± 689 cGycm2, p < 0.001). Procedure duration was significantly longer in the RMN group (88 ± 29 vs. 79 ± 29 min; p = 0.03) and crossover from the RMN group to manual ablation occurred in 7.6% of patients (7.6 vs. 0.1%; p = 0.02). Acute success was achieved in 100% of patients in both groups. Midterm success after 6 months was 97 vs. 98% (p = 0.67). No complications occurred in both groups. CONCLUSION: The use of RMN for catheter ablation of AVNRT compared to a manual approach results in a reduction of fluoroscopy time and dosage of about 50% for both patients and physicians. Acute and midterm success and safety are comparable. RMN is a good alternative to a manual approach for AVNRT ablation.


Subject(s)
Catheter Ablation/methods , Heart Conduction System/surgery , Magnetics , Surgery, Computer-Assisted/methods , Tachycardia, Atrioventricular Nodal Reentry/surgery , Electrocardiography, Ambulatory , Female , Fluoroscopy/methods , Follow-Up Studies , Heart Conduction System/physiopathology , Humans , Male , Middle Aged , Prospective Studies , Tachycardia, Atrioventricular Nodal Reentry/diagnosis , Tachycardia, Atrioventricular Nodal Reentry/physiopathology , Time Factors , Treatment Outcome , Ultrasonography, Doppler, Duplex
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