High-power chargers for electric vehicles: are they safe for patients with pacemakers and defibrillators?

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.

Feasibility and safety of left atrial access for ablation of atrial fibrillation in patients with persistent left superior vena cava.

BACKGROUND: In patients with persistent left superior vena cava (PLSVC) ablation procedures can be challenging. We sought to determine the feasibility and safety of left atrial ablations in patients with PLSVC, especially when PLSVC is unknown prior to the ablation procedure. METHODS AND RESULTS: In this retrospective analysis 15 adult patients (mean age 64.6 ± 14.5 years, 53.3% male) with PLSVC undergoing 27 ablation procedures for atrial fibrillation or left atrial flutter were included. In 5 (33.3%) patients PLSVC was only discovered during the procedure. Transseptal puncture (TSP) was declared "difficult" by the ablating physician in 13 of 27 (48.2%) procedures and was not successfully completed in the first attempt in two patients with known PLSVC. Once TSP was successfully completed, all relevant structures were reached both during mapping and ablation in all procedures independent of whether PLSVC was known prior to the procedure. One major complication (3.7%) occurred in 27 procedures in a patient with known PLSVC. In the patients with unknown PLSVC no complication occurred. CONCLUSION: In experienced hands, left atrial access and ablation in patients with PLSVC is feasible and safe, particularly with regard to patients in whom the PLSVC is unknown prior to the ablation procedure.

Clinical valuation of ST changes in a group of patients with ventricular arrhythmias: The inSighT Study.

BACKGROUND: The inSighT study was designed to determine the prevalence of ischemic changes as recorded by implantable cardioverter-defibrillator (ICD) ST deviations in intracardiac electrocardiograms (EGM) over the 24 h preceding malignant ventricular arrhythmias (VT/VF). METHODS: The study enrolled patients with known coronary artery disease (CAD) or high risk of future development of CAD implanted with an ICD equipped with an ST monitoring feature (Ellipse™/Fortify Assura™, St. Jude Medical). Device session records were collected at each in-clinic follow-up. EGM ST levels of the beats over the 15 minutes prior to VT/VF events were compared using a t test with those from a baseline period of 23-24 h prior to the VT/VF event. All events with p < .05 were visually inspected to confirm they were evaluable; additional criteria for exclusion from further analysis included inappropriate therapy, aberrant conduction, and occurrence of VT/VF within 24h prior to the current event. RESULTS: The study enrolled 481 ICD patients (64 ± 11 years, 83% male) in 14 countries and followed them for 15±5 months. A total of 165 confirmed VT/VF episodes were observed, of which 71 events (in 56 patients, 34% of all patients with VT/VF) were preceded by significant (p < .05) ST-segment changes unrelated to known non-ischemic causes. None of the analyzed demographic and clinical factors proved to be associated with greater odds of presenting with ST-segment changes prior to VT/VF episode. CONCLUSION: In this exploratory study, characteristic ST-segment changes, likely representative of ischemic events, were observed in 34% of all patients with VT/VF episodes.

Cardiac resynchronisation therapy in patients with left bundle branch block with residual conduction.

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.

Atrial electrogram quality in single-pass defibrillator leads with floating atrial bipole in patients with permanent atrial fibrillation and cardiac resynchronization therapy.

Many patients receiving cardiac resynchronization therapy (CRT) suffer from permanent atrial fibrillation (AF). Knowledge of the atrial rhythm is important to direct pharmacological or interventional treatment as well as maintaining AV-synchronous biventricular pacing if sinus rhythm can be restored. A single pass single-coil defibrillator lead with a floating atrial bipole has been shown to obtain reliable information about the atrial rhythm but has never been employed in a CRT-system. The purpose of this study was to assess the feasibility of implanting a single coil right ventricular ICD lead with a floating atrial bipole and the signal quality of atrial electrograms (AEGM) in CRT-defibrillator recipients with permanent AF. METHODS AND RESULTS: Seventeen patients (16 males, mean age 73 ±â€¯6 years, mean EF 25 ±â€¯5%) with permanent AF and an indication for CRT-defibrillator placement were implanted with a designated CRT-D system comprising a single pass defibrillator lead with a atrial floating bipole. They were followed-up for 103 ±â€¯22 days using remote monitoring for AEGM transmission. All patients had at last one AEGM suitable for atrial rhythm diagnosis and of 100 AEGM 99% were suitable for visual atrial rhythm assessment. Four patients were discharged in sinus rhythm and one reverted to AF during follow-up. CONCLUSION: Atrial electrograms retrieved from a single-pass defibrillator lead with a floating atrial bipole can be reliably used for atrial rhythm diagnosis in CRT recipients with permanent AF. Hence, a single pass ventricular defibrillator lead with a floating bipole can be considered in this population.

Transseptal Puncture Guided by CT-Derived 3D-Augmented 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.

Electromagnetic Contact-Force Sensing Electrophysiological Catheters: How Accurate is the Technology?

BACKGROUND: 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.

Evaluation of a new very low dose imaging protocol: feasibility and impact on X-ray dose levels in electrophysiology procedures.

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.

Impact of the Right Ventricular Lead Position on Clinical End Points in CRT Recipients--A Subanalysis of the Multicenter Randomized SPICE Trial.

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.

Dissociated pulmonary vein activity after pulmonary vein isolation for paroxysmal atrial fibrillation: a predictor for recurrence?

BACKGROUND: The role of dissociated pulmonary vein (DPV) activity after pulmonary vein isolation (PVI) is still poorly defined. We evaluated electrophysiological features and clinical impact on long-term outcome of DPV activity. METHODS: A total of 243 patients (mean age 63 ± 11 years; 63% males) undergoing PVI for paroxysmal atrial fibrillation (AF) were included. DPV activity was defined as a residual low frequency irregular PV rhythm. Patients were divided into Group 1 (presence of DPV activity; n = 65) or Group 2 (absence of DPV activity; n = 178). RESULTS: Of 936 isolated PVs, 112 PVs (12%) showed DPV activity. DPV activity was observed more frequently in PVs identified as AF triggers (P = 0.026). During follow-up (mean 12 ± 7 months), 15 of 65 patients of Group 1 (23%) and 57 of 178 patients of Group 2 (32%) had an arrhythmia recurrence (P = 0.23). At linear regression analysis, no independent predictor for clinical recurrence was identified. During the repeat ablation, 62 of 72 patients (86%) showed a recovered PV conduction without difference between the 2 groups. Clinically, all patients of Group 1 with PV reconnection (n = 13/15) had a recurrence of paroxysmal AF. In Group 2, 5 of 52 patients with reconnected PV developed non-PV related arrhythmias. CONCLUSION: DPV activity occurred in 12% of PVs after PVI and was observed more frequently in PVs identified as AF triggers. DPV activity was not predictive for AF recurrence during follow-up. PV-left atrium reconnection involving PVs with DPV activity leads to AF.

Sensor-Based Electromagnetic Navigation (Mediguide®): How Accurate Is It? A Phantom Model Study.

BACKGROUND: Data about localization reproducibility as well as spatial and visual accuracy of the new MediGuide® sensor-based electroanatomic navigation technology are scarce. We therefore sought to quantify these parameters based on phantom experiments. METHODS AND RESULTS: A realistic heart phantom was generated in a 3D-Printer. A CT scan was performed on the phantom. The phantom itself served as ground-truth reference to ensure exact and reproducible catheter placement. A MediGuide® catheter was repeatedly tagged at selected positions to assess accuracy of point localization. The catheter was also used to acquire a MediGuide®-scaled geometry in the EnSite Velocity® electroanatomic mapping system. The acquired geometries (MediGuide®-scaled and EnSite Velocity®-scaled) were compared to a CT segmentation of the phantom to quantify concordance. Distances between landmarks were measured in the EnSite Velocity®- and MediGuide®-scaled geometry and the CT dataset for Bland-Altman comparison. The visualization of virtual MediGuide® catheter tips was compared to their corresponding representation on fluoroscopic cine-loops. Point localization accuracy was 0.5 ± 0.3 mm for MediGuide® and 1.4 ± 0.7 mm for EnSite Velocity®. The 3D accuracy of the geometries was 1.1 ± 1.4 mm (MediGuide®-scaled) and 3.2 ± 1.6 mm (not MediGuide®-scaled). The offset between virtual MediGuide® catheter visualization and catheter representation on corresponding fluoroscopic cine-loops was 0.4 ± 0.1 mm. CONCLUSIONS: The MediGuide® system shows a very high level of accuracy regarding localization reproducibility as well as spatial and visual accuracy, which can be ascribed to the magnetic field localization technology. The observed offsets between the geometry visualization and the real phantom are below a clinically relevant threshold.

Ablation of perimitral flutter: acute and long-term success of the modified anterior line.

AIMS: The modified anterior line (MAL) is an alternative to the mitral isthmus (MI) line for the treatment of perimitral atrial flutter (PMFL). We sought to investigate acute and long-term efficacy of this line if routinely used for PMFL. METHODS AND RESULTS: The cohort included 77 consecutive patients who underwent catheter ablation of PMFL. The anterior line was deployed between the anterolateral mitral annulus and the ostium of the left superior pulmonary vein. Perimitral atrial flutter was either the presenting arrhythmia after persistent atrial fibrillation (AF) ablation (Group 1, n = 42, 54.5%), occurring during AF ablation (Group 2, n = 25, 35%) or presenting as primary arrhythmia (Group 3, n = 8, 10%). Acute success was defined as PMFL termination during MAL deployment with demonstration of bidirectional line block. Acute success was achieved in 68 of 77 patients (88%) without difference between the three groups. In five patients an additional MI line was necessary to terminate PMFL and in four patients both lines failed to achieve termination. During follow-up (16 ± 7 months), 38 of 77 (49%) patients underwent a repeat procedure for a recurrent arrhythmia. During reablation, 13 of 38 (34%) patients were identified to have a PMFL recurrence. Persistent MAL block was demonstrated in 22 of 38 (58%) patients during the repeat ablation. CONCLUSION: The MAL is effective for acute and long-term treatment of PMFL. Maintenance of bidirectional MAL block was shown in 58% of patients during a repeat ablation.

A stepwise electrocardiographic algorithm for differentiation of mid-septal vs. apical right ventricular lead positioning: the SPICE ECG substudy.

AIMS: Right ventricular (RV) septum is a non-apical site targeted during lead implantation. Electrocardiographic (ECG) recognition of mid-septal lead location is challenging. The aim of the study is to determine ECG correlates of RV mid-septal pacing. METHODS AND RESULTS: The present study is a pre-specified analysis of a prospective, multicenter study, which randomized recipients of an implantable cardioverter defibrillator to an apical vs. mid-septal RV lead positioning. Following implantation, a 12-lead ECG was recorded during intrinsic rhythm and RV pacing. In total, 227 patients, 121 in the apical group (76.9% males, 67.1 ± 11.3 years) and 106 in the mid-septal group (82.1% males, age 64.7 ± 12.7 years) were included. Apically as compared with septally paced patients had significantly longer paced QRS duration (177.0 ± 25.0 vs. 170.4 ± 21.7, respectively, P = 0.03) and significantly more leftward paced QRS axis (-71.6 ± 33.3° vs. 9.4 ± 86.5°, respectively, P < 0.001). A significantly higher proportion of patients in the mid-septal as compared with the apical group displayed predominantly positive QRS in lead V6 (62.3 vs. 4.1%, P < 0.001), predominantly positive QRS in any of the inferior leads (53.8 vs. 4.1%, P < 0.001), and a QR pattern in lead aVL (53.3 vs. 3.3%, P < 0.001). These ECG correlates were incorporated in a stepwise algorithm with total sensitivity of 87% and specificity of 90% for the identification of a mid-septal lead location. CONCLUSION: A mid-septal lead location may be identified using a simple stepwise algorithm, based on the presence of positive QRS in lead V6, positive QRS in any of the inferior leads, and a QR pattern in lead aVL.

Catheter Ablation of Ventricular Arrhythmias using a Fluoroscopy Image Integration Module.

BACKGROUND: The impact of the CartoUnivu™ technology (Biosense Webster, Diamond Bar, CA, USA) on fluoroscopy exposure compared to a conventional approach using electroanatomical mapping (Carto 3™) was evaluated in patients undergoing radiofrequency ablation for ventricular tachyarrhythmias (VT). METHODS AND RESULTS: We prospectively evaluated 23 patients undergoing VT ablation using the CartoUnivu™ technology. The CartoUnivu™ Module integrates fluoroscopic images and cine loops into the electroanatomical mapping system. As a control group, 23 out of 88 VT patients (ablated using conventional fluoroscopy supplemented by electromagnetic mapping with the Carto 3™ System) were matched for age, gender, body surface area, operator, redo-procedure, presence of coronary artery disease, and left ventricular dysfunction using propensity score matching. A significant reduction in fluoroscopy exposure was observed in the CartoUnivu™ group when compared to the conventional group (10.57 ± 7.93 minutes vs 18.52 ± 11.24 minutes, P_= 0.008; 611 cGy/cm(2) vs 1650 cGy/cm(2) , P = 0.001). In multivariate analysis, the CartoUnivu™ module was an independent predictor of reduced fluoroscopy use. CONCLUSION: This is a report on the clinical application of the CartoUnivu system for VT ablation. CartoUnivu™ markedly reduced fluoroscopy time and dose compared to conventional fluoroscopy/electroanatomical mapping.

Three-dimensional echocardiographic optimization improves outcome in cardiac resynchronization therapy compared to ECG optimization: a randomized comparison.

AIMS: There is little consensus on optimal atrioventricular (AV) and ventricular-to-ventricular (VV) intervals in cardiac resynchronization therapy (CRT). The aim of this study was to examine a novel combination of Doppler echocardiography (DE) and three-dimensional echocardiography (3DE) for individualized AV- and VV-interval optimization compared to conventional electrocardiogram (ECG) optimization. METHODS: In this double-blind, randomized controlled trial, 77 patients (male: 57, age: 68 ± 10 years) with severely reduced ejection fraction (EF), New York Heart Association (NYHA) class III or IV, and wide QRS complex (>120 ms) have been included. Patients were randomized to either AV- and VV-interval optimization using DE and 3DE (group 1, n = 39) or ECG (group 2, n = 38). 3DE was performed in all patients for the evaluation of left ventricular (LV) dimensions, EF and systolic dyssynchrony index (SDI), and NYHA class obtained before CRT and after 3 months. Primary endpoint of the study was clinical response to CRT, defined as a reduction of NYHA class by ≥1 score. Secondary endpoints were change of EF, LV volumes, and SDI. RESULTS: There were significantly more responders in group 1 (82%) than in group 2 (58%, P = 0.021). Similarly, group 1 showed a larger increase in EF (7.0 ± 6.0% vs 3.4 ± 5.6%, P = 0.015) and a more pronounced reduction of SDI (-4.5 ± 5.9% vs -1.5 ± 5.6%, P = 0.039) than group 2. CONCLUSION: Compared with conventional ECG optimization, this novel echocardiographic optimization protocol resulted in a significantly higher response rate, improved LV systolic function, and may be used to select the optimal AV and VV intervals in CRT.

Pulsed field ablation in patients with cardiac implantable electronic devices: an ex vivo assessment of safety.

BACKGROUND: Pulse field ablation (PFA) is a novel catheter ablation technology with potential safety benefits due to its tissue selectivity. It has the potential to directly damage or interact with the functionality of cardiac implantable electronic devices (CIEDs) in the form of electromagnetic interference (EMI). The aim of our study was to assess the impact of PFA on CIEDs. METHODS: PFA lesions (45 per CIED) were applied from the Farapulse system to CIEDs (< 5 cm from the lead tip and < 15 cm from the generator). All devices were checked before and after PFA application for proper sensing and pacing functionality as well as for integrity of shock circuits in ICDs using a heart simulator. Moreover, devices were then interrogated for any spontaneous reprogramming, mode switching or other EMI effects. RESULTS: In total, 44 CIEDs were tested (16 pacemaker, 21 ICDs, 7 CRT-P/D) with 1980 PFA applications. There was no change in device settings, functionality and electrical parameters, and there was no macroscopic damage to the devices. The risk of damage to the electric components or leads on a patient-based analysis is 0/44 (95% CI 0-8%) and on a PFA pulse-based analysis is 0/1980 (95% CI 0-0.2%). Clinically relevant EMI appeared with oversensing and pacing inhibition but not tachycardia detection. CONCLUSIONS: Bipolar PFA appears safe and does not result in damage to CIEDs or leads. Clinically relevant EMI does occur, but appropriate peri-procedural programming may mitigate this. In vivo studies are needed to confirm our findings.

Importance of sinus rhythm as endpoint of persistent atrial fibrillation ablation.

BACKGROUND: The endpoint of persistent atrial fibrillation (AF) ablation is still a matter of debate. The purpose of this study was to evaluate if sinus rhythm (SR) as endpoint of persistent AF ablation has a better long-term outcome compared to atrial tachycardia (AT) or AF at the end of the procedure. METHODS AND RESULTS: Between 2008 and 2011, 191 consecutive patients undergoing de novo catheter ablation for symptomatic persistent and long-standing persistent AF using a sequential ablation approach (including pulmonary vein isolation, ablation of complex fractionated electrograms and linear lesions) were included in the study. According to the result at the end of ablation procedure, patients were classified into 3 groups: patients with termination of AF into SR (Group 1, n = 62), patients with AT undergoing cardioversion (CV) (Group 2, n = 47), or patients with AF undergoing CV (Group 3, n = 82). The primary endpoint was freedom from any atrial tachyarrhythmia off antiarrhythmic drugs at 12 months. At 12 months, estimated proportions of patients free from any arrhythmia recurrence were 42% for Group 1, 13% for Group 2, and 25% for Group 3 (P = 0.002). In a Cox regression analysis only termination into SR was associated with a lower risk of arrhythmia recurrence (HR: 0.62; P = 0.04). CONCLUSION: If SR is achieved as endpoint of persistent and long-standing persistent AF ablation using a sequential ablation approach it is associated with the highest long-term single procedure success rate compared to AT or AF at the end of the procedure.

Acute and long-term outcome after catheter ablation of supraventricular tachycardia in patients after the Mustard or Senning operation for D-transposition of the great arteries.

AIMS: Data about the acute and long-term outcome of catheter ablation in patients with D-transposition of the great arteries (d-TGA) post-Mustard/Senning operation are scarce. METHODS AND RESULTS: This single-centre retrospective analysis includes 26 patients (mean age 28.7 ± 6.7 years, 8 females) after Mustard (n = 15) or Senning (n = 11) operation who underwent catheter ablation for intra-atrial re-entrant tachycardia (IART) or atrioventricular nodal re-entrant tachycardia (AVNRT) from January 2004 to May 2011. The electrophysiological studies were performed using a three-dimensional mapping system (CARTO). Remote magnetic navigation (RMN) was available since 2008. Follow-up on an outpatient basis was conducted 3, 6, and 12 months after ablation and yearly thereafter. In the 26 patients, 34 procedures were performed (one procedure n = 19, two n = 6, and three n = 1). Overall, 34 tachycardia forms (IART n = 30; AVNRT n = 4) were ablated manually (n = 25) or by RMN (n = 9). Acute success reached in 29/34 forms (85.3%). Mean fluoroscopy time (FT) was 28.2 ± 20.7 min and mean procedure duration (PD) was 290.9 ± 107.6 min. After a mean follow-up of 34.1 ± 24.5 months, 25/26 (96.2%) patients were free from IART or AVNRT. In the nine RMN ablations (mean follow-up 14.2 ± 5.8 months) acute and long-term success was 100%. Fluoroscopy time and PD were significantly reduced using RMN compared with manual ablation (11.9 ± 6.2 vs. 34.6 ± 20.6 min, 225.7 ± 24.1 vs. 312 ± 118.2 min, P = 0.02). CONCLUSION: Catheter ablation of IART or AVNRT in patients post-Mustard/Senning operation for d-TGA has a high acute success rate. The recurrence rate for IART is about 30%; however, after a second ablation, long-term results are excellent. Remote magnetic navigation seems to improve single-procedure acute and long-term success and significantly reduces FT and PD.