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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.

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.

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.

Der subkutane implantierbare Kardioverter-Defibrillator (S-ICD) ist eine etablierte Therapie zur Pravention des plotzlichen Herztods. Auf Grund seines Detektionsalgorithmus ist er jedoch ganz wesentlich auf eine korrekte Morphologieerkennung des QRS-Komplexes angewiesen, ohne dass es zu einer zusatzlichen Wahrnehmung der T‑Welle kommt. In diesem Zusammenhang wird uber einen Patienten berichtet, bei dem wegen eines neu aufgetretenen Rechtsschenkelblocks ein T‑Wellen-Oversensing zu inadaquaten Schocks gefuhrt hat. Nachfolgend werden Moglichkeiten zur optimalen Gerateprogrammierung diskutiert.

For physicians involved in the treatment of patients with implantable cardioverter-defibrillators (ICDs) the knowledge of tachycardia detection algorithms is of paramount importance. This knowledge is essential for adequate device selection during de-novo implantation, ICD replacement, and for troubleshooting during follow-up. This review describes tachycardia detection algorithms incorporated in ICDs by Sorin/LivaNova and analyses their strengths and weaknesses.

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.

Accuracy of MediGuide® Navigation 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.

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/cm2 vs 1650 cGy/cm2, 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.

Die MADIT-RIT-Studie stellt eine der bedeutendsten Studien zu implantierbaren Kardioverter-Defibrillatoren (ICD) der letzten Jahre dar. Sie stellt in besonderer Weise heraus, dass unterschiedliche Programmierstrategien (hohe Detektionsfrequenz oder verzogerte Therapie vs. konventionelle Einstellung) die Haufigkeit inadaquater ICD-Therapien reduziert, das Synkopenrisiko unverandert belasst und zu einem verbesserten Patientenuberleben fuhren kann. Die Studie sollte alle Kardiologen und Elektrophysiologen dazu anhalten, ihre gegenwartigen Programmierstrategien kritisch zu hinterfragen. Allerdings wurden in die Studie v. a. Patienten mit ischamischer oder dilatativer Kardiomyopathie eingeschlossen, die zur Primarprophylaxe des plotzlichen Herztods einen Zweikammer-ICD oder ein ICD zur Resynchronisationstherapie erhalten haben, und es konnen die Ergebnisse der Studie nicht unbedingt auf andere Krankheitsbilder und andere Geratearten ubertragen werden. Trotz des Erfolgs der MADIT-RIT-Studie sind weitere Anstrengungen erforderlich, um die ICD-Algorithmen zur Arrhythmiedetektion weiter zu verbessern und inadaquate Therapien zu minimieren. Eine optimierte ICD-Therapie schliest zudem die Vermeidung von unnotigen Schocks und die Behandlung aller anderen Aspekte der kardialen Grunderkrankung mit ein.

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.

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.

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.

Electrocardiographic (ECG) identification of prior myocardial infarction (MI) during right ventricular (RV) pacing is of clinical importance. Proposed ECG criteria have been evaluated only during apical pacing. We evaluated the effect of pacing site on the predictive performance of ECG signs of prior MI.The present study is a secondary analysis of a prospective, multicenter study which randomized recipients of an implantable cardioverter defibrillator to an apical versus septal RV lead positioning. ECGs of patients with or without prior MI were analyzed for the presence of the following criteria: Cabrera sign, Chapman sign, QR pattern in leads I, aVL, V5 or V6, QR in inferior leads and notching in the descending slope of the QRS complex in inferior leads.The MI group included 89 patients (55.1% apically paced), while 99 patients had no prior MI (50.5% apically paced). In the total population, the Cabrera sign presented the highest specificity (97%) and diagnostic accuracy (62.2%), with a sensitivity of 23.6%. The Cabrera sign was the only significant predictor of a prior MI [OR=9.9, (95%CI:2.8-34.5), p0.001], among all ECG markers. Pacing site did not significantly influence the sensitivity and specificity of the Cabrera sign for detection of prior MI.In our study, the Cabrera sign was the only ECG marker that predicted the presence of prior MI during ventricular paced rhythm. Septal RV lead positioning did not affect the predictive performance of the Cabrera sign.

Background Detrimental effects of right ventricular (RV) apical pacing have directed the interest toward alternative pacing sites such as the RV mid-septum. As safety data are scarce for implantable cardioverter defibrillator (ICD) recipients the study aims to evaluate ICD lead performance in the mid-septal position. Methods and results A total of 299 ICD recipients (79% male, aged 65.2±12.1years, 83% primary prevention of sudden cardiac death) were randomized to receive the RV ICD electrode either in a mid-septal (n=145) or apical (n=154) location. Event-free survival was evaluated at 3 (primary endpoint) and 12months (secondary endpoint). Events included a composite of lead revision, suboptimal right ventricular electrode performance (including defibrillation thresholds (DFT)>25J) or lead position not in accordance with randomized location. Event-free survival at 3 (12) months was observed in 80.6% (72.3%) of patients randomized to a mid-septal and in 82.2% (72.1%) of patients randomized to an apical lead position, p=0.726 (p=0.969). Pre-defined margins for non-inferiority were not reached at 3 or 12months. High DFT was found in 7 patients (5.0%) of the mid-septal and in 3 (2.2%) patients of the apical group (p=0.209). Conclusion In ICD recipients electrode positioning to the RV mid-septum or the RV apex results in slightly different rates concerning the survival free of lead revision, suboptimal right ventricular electrode performance or non-randomized lead position. Non-inferiority of the mid-septal lead location cannot be concluded. This should be taken into consideration when a mid-septal lead position is pursued. Clinical trial registration ClinicalTrials.gov identifier NCT00745745.

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.

Background Automatic atrioventricular search hysteresis (AVSH) is designed to reduce the cumulative percentage of potentially deleterious right ventricular apical pacing (VP%) in dual-chamber pacemakers. We investigated whether minimizing VP% by AVSH can, in turn, reduce ventricular wall stretching/stress, as assessed by plasma concentrations of the amino-terminal fragment of the pro-B-type natriuretic peptide (NT-proBNP). Methods After dual-chamber pacemaker implantation in 81 patients (age: 69 ± 11 years; males: 55.6%), the fixed atrioventricular delay of 225 ms was programmed and AVSH was turned off for 1 month. The patients were thereafter randomly assigned to standard AVSH for 1 month, followed by an enhanced AVSH for another month, or vice versa. At the 1-, 2-, and 3-month follow-ups, VP% values were retrieved from the pacemaker memory, and venous blood samples were taken for NT-proBNP measurements. Results Both standard and enhanced AVSH reduced the median VP% value from 38.5% (for the fixed atrioventricular delay) to 2.1% (P < 0.001). However, plasma NT-proBNP concentrations for the fixed atrioventricular delay (median, 253 pg/mL), standard AVSH (225 pg/mL), and enhanced AVSH (276 pg/mL) did not differ significantly on the intrapatient basis (paired Wilcoxon tests) between any pair of these modalities. Conclusion Minimizing ventricular pacing by AVSH during 1 month had no influence on plasma NT-proBNP levels (i.e., ventricular wall stretching/stress) compared with a constant, moderately prolonged atrioventricular delay.

The implantable cardioverter defibrillator (ICD) is the gold standard therapy to prevent life-threatening arrhythmias. Phobic anxiety predicts ventricular arrhythmia in coronary heart disease patients, but little is known about phobic anxiety in ICD patients. This study aimed to identify determinants and the course of phobic anxiety in ICD patients.140 outpatients living with an ICD (mean age 56±14 years, 66% men).Phobic anxiety was assessed with the Symptom Checklist-90 Revised at a mean of 27±21 months (range 3-109) post-ICD placement (baseline) and after an average follow-up of 41±18 months (range 10-82). Multivariate linear regression models considered sociodemographic factors, clinical variables and psychological scales as potential determinants of phobic anxiety scores.ICD patients reported more than 10-fold higher levels of phobic anxiety than a previous representative population survey (2.6±3.4 vs 0.2±0.4). Greater age (p=0.003), previous shock experience (p=0.007), depressed mood (p0.001) and hypochondriasis (p=0.005) were associated with higher phobic anxiety scores at baseline. Multimorbidity (p=0.030) and higher baseline phobic anxiety (p0.001) determined greater phobic anxiety at follow-up. Younger age (p=0.029) and an elevated number of non-cardiac diseases (p=0.019) were both associated with an increase in phobic anxiety scores from baseline to follow-up. More patients had high phobic anxiety levels (score4) at follow-up compared with baseline (31% vs 24%; p=0.048).Phobic anxiety was comparably high and persisted over time in ICD patients. Modifiable determinants of phobic anxiety were identified, which may inform tailored interventions to improve ICD patients' distress and perhaps also prognosis.

Aims Data about the long-term outcome after cryoablation for atrioventricular nodal reentrant tachycardia (AVNRT) in the paediatric population indicate that recurrence rates are higher with cryo than with radiofrequency energy (RF). The purpose of this study was to review our institutional long-term outcome after cryoablation for AVNRT and to seek for predictors of recurrence. Methods and results Forty-nine patients (28 female, age 14 ± 2.7 years) undergoing slow-pathway modulation or ablation for AVNRT at our institution from 2004 to 2008 were included in the study. Acute success was obtained in all patients (100%) with a mean procedure time of 164 ± 50 min and a mean fluoroscopy time of 13 ± 8 min. During a follow-up time of 30 ± 1.9 months, AVNRT recurrence occurred in 11/49 patients (22.4%). Age, sex, number of cryomappings or ablations, catheter tip (4 mm vs. 6 mm), or ablation endpoint (slow-pathway ablation vs. modulation) were not predictive for recurrence. In eight patients, reablation using cryo was performed. All these patients remained free of arrhythmia symptoms during a follow-up of 30 ± 8 months following the second procedure. Conclusion Although cryoablation for the treatment for AVNRT in paediatric and adolescent patients is safe and associated with a high acute success rate, AVNRT recurrence occurs in 22% of patients during long-term follow-up without identifiable predictors for recurrence. A second cryoablation procedure leads to a success rate of 100% during long-term follow-up.

The implantable cardioverter-defibrillator (ICD) is highly effective in the therapy of malign heart rhythm abnormalities. However, the ethical dilemma of harming a dying patient has received little attention. We studied the current state of knowledge and behavior of physicians and the subjective needs of ICD patients with respect to end-of-life issues.A literature search of articles published between 8/2010 and 3/2011 in PubMed resulted in the identification of 32 reports, of which 25 met selection criteria.Practically no clinical institution (96% in Europe) offers routine counseling of ICD patients on end-of-life issues. In only about 25% of cases do doctors initiate a discussion on this issue with the ICD patient, of which the majority takes place during the final hours of the patient's life. Knowledge of legal aspects of ICD deactivation is insufficient in about 50% of physicians. Many physicians underestimate the impact of ICD shocks and often have unrealistic expectations about the patient's knowledge on technical aspects of the ICD device. The majority of patients are reluctant to address this topic and prefer to rely on the decision of their attending physician.Despite insufficient empirical data, findings point to a low willingness of ICD patients to confront the end-of-life issue and prefer decisions to be made by their physician. Substantial knowledge gaps of physicians may cause barriers in considering the option of deactivating the ICD.

Patients with an implantable cardioverter defibrillator (ICD) show clinically relevant depression and anxiety, but little is known about their levels of posttraumatic stress. We assessed chronic posttraumatic stress attributable to a traumatic cardiac event and its predictors in patients at two time points after ICD placement.We investigated 107 consecutively enrolled patients (57 ± 14 years, 62% men) on average 24 ± 21 months after ICD placement (baseline) and again 41 ± 18 months later (follow-up). All patients completed the Impact of Event Scale-Revised (IES-R) to self-rate the severity of posttraumatic stress (range 0-110). The 30% of patients with the highest IES-R scores (≥ 25) at baseline were defined as PTSD cases; the same threshold was applied to define PTSD caseness at follow-up.Posttraumatic stress increased from baseline to follow-up (19 ± 22 vs. 25 ± 19, p0.001); 19% of patients had PTSD at both assessments, 12% at baseline only, and 18% at follow-up only. Female gender as well as greater peritraumatic dissociation and depression predicted greater posttraumatic stress at baseline (p-values ≤ 0.041). Greater baseline posttraumatic stress, helplessness, alexithymia, and ≥ 5 shocks during follow-up all predicted greater posttraumatic stress at follow-up (p-values ≤ 0.029). Female gender, helplessness, and depression predicted PTSD at baseline (p-values ≤ 0.022); low education and posttraumatic stress at baseline predicted PTSD at follow-up (p-values ≤ 0.003).Between 2 and 5.5 years post-ICD placement chronic posttraumatic stress slightly increased and nearly one-fifth of patients had newly developed PTSD. The identified psychological predictors of long-term chronicity of posttraumatic stress might particularly inform behavioral interventions for ICD recipients.

Right ventricular pacing predisposes to the development of heart failure and atrial fibrillation. Automatic atrioventricular search hysteresis (AVSH) is a commonly used strategy to decrease the percentage of right ventricular pacing (%VP) in patients without permanent AV block, but the results have not been optimal.The randomized, crossover PREVENT study evaluated whether an enhanced AVSH with two new features can reduce %VP compared with standard AVSH. The new features are the repetitive hysteresis [switch from extended to basic AV delay after a consistent loss of intrinsic AV conduction (IAVC) lasting for six consecutive atrial cycles] and the scan hysteresis (periodic IAVC search extension over six consecutive atrial cycles). Both standard AVSH and enhanced AVSH performed a periodic IAVC search every 180 cardiac cycles and operated with a basic AV-delay of 225 ms and a rate-independent maximum AV-delay of 300 ms for paced and sensed atrial events.Among 178 patients, 53.4% had no evidence of AV block at enrollment and 46.6% had history of intermittent AV block. The median %VP was decreased by enhanced AVSH compared to standard AVSH (4.0% vs 5.5%, P 20% relative %VP reduction was not met as 46 (25.8%) patients (95% confidence interval, 20.5-31.8%) presented such relative reduction.The enhanced AVSH algorithm reduces %VP compared with standard AVSH in patients with intermittent AV block.

Introduction: Depression predicts mortality in patients with coronary artery disease and heart failure. However, its effect on patient outcome in the presence of an implantable cardioverter defibrillator (ICD) has not been investigated. Methods: A total of 236 ICD patients (76 females, 58.6 ± 14.0 years) were screened for depressive symptoms using the Hospital Anxiety and Depression Scale (HADS). The outcome measure was all-cause mortality and the prognostic effect of depression was evaluated with Cox proportional hazards regression analysis. Results: Fifty (21%) patients reported depressive symptoms (HADS score ≥ 8). Renal failure (odds ratio [OR]= 4.0, 95% confidence intervals [CI]= 1.47–10.87, P = 0.007), prior angina (OR = 2.1, 95% CI = 1.07–4.12, P = 0.03), but not the experience of ICD shocks were associated with baseline depressive symptoms. In a mean follow-up period of 6.1 ± 2.5 years, 74 patients (31%) died. Mortality significantly increased from 45.1 deaths per 1,000 person-years among patients without depression to 80.3 deaths per 1,000 person-years in patients with depressive symptoms (P = 0.039). In the univariate model, depression (HADS score ≥8) was a significant predictor of mortality (OR = 1.81, 95% CI = 1.1–3.0, P = 0.02). However, in the multivariate model, depression lost its prognostic significance. Conclusions: In our prospective patient cohort, one-fifth of ICD recipients reported depressive symptoms. Depression increased the absolute mortality risk but was not an independent predictor of mortality. (PACE 2011; 34:991–997)

Background— Cryoablation has emerged as an alternative to radiofrequency catheter ablation (RFCA) for the treatment of atrioventricular (AV) nodal reentrant tachycardia (AVNRT). The purpose of this prospective randomized study was to test whether cryoablation is as effective as RFCA during both short-term and long-term follow-up with a lower risk of permanent AV block. Methods and Results— A total of 509 patients underwent slow pathway cryoablation (n=251) or RFCA (n=258). The primary end point was immediate ablation failure, permanent AV block, and AVNRT recurrence during a 6-month follow-up. Secondary end points included procedural parameters, device functionality, and pain perception. Significantly more patients in the cryoablation group than the RFCA group reached the primary end point (12.6% versus 6.3%; P =0.018). Whereas immediate ablation success (96.8% versus 98.4%) and occurrence of permanent AV block (0% versus 0.4%) did not differ, AVNRT recurrence was significantly more frequent in the cryoablation group (9.4% versus 4.4%; P =0.029). In the cryoablation group, procedure duration was longer (138±54 versus 123±48 minutes; P =0.0012) and more device problems occurred (13 versus 2 patients; P =0.033). Pain perception was lower in the cryoablation group ( P Conclusions— Cryoablation for AVNRT is as effective as RFCA over the short term but is associated with a higher recurrence rate at the 6-month follow-up. The risk of permanent AV block does not differ significantly between cryoablation and RFCA. The potential benefits of cryoenergy relative to ablation safety and pain perception are counterbalanced by longer procedure times, more device problems, and a high recurrence rate. Clinical Trial Registration— URL: http://www.clinicaltrials.gov . Unique identifier: NCT00196222.

Background: Implantable cardioverter-defibrillators (ICDs) represent the treatment of choice for primary and secondary prevention of sudden cardiac death but ICD therapy is also plagued by inappropriate shocks due to supraventricular tachyarrhythmias. Dual-chamber (DC) ICDs are considered to exhibit an enhanced discrimination performance in comparison to single-chamber (SC) ICDs, which results in reduction of inappropriate detections in a short- to mid-term follow-up. Comparative data on long-term follow-up and especially on inappropriate shocks are limited. Methods: The aim of the OPTION study is to assess whether an optimized treatment with DC ICDs improves patient outcome and decreases the rate of inappropriate shocks in comparison to SC ICDs. DC ICD therapy optimization is achieved by optimal customizing of antitachycardia therapy parameters, activation of discrimination algorithms, antitachycardia pacing in the slow ventricular tachycardia zone, and avoidance of right ventricular pacing with the SafeR algorithm mode. The OPTION study, a prospective, multicenter, randomized, single-blinded, parallel study, will randomize 450 patients on a 1:1 allocation to either an SC arm with backup pacing at VVI 40 beats per minute (bpm) or to the DC arm with SafeR pacing at 60 bpm. Patients will be followed for 27 months. Primary outcome measure is the time to first occurrence of inappropriate shock and a combined endpoint of cardiovascular morbidity and all-cause mortality. Conclusion: The study will evaluate the relative performance of DC in comparison to SC ICDs in terms of inappropriate shock reduction and patient outcome. (PACE 2010; 33:1141–1148)

Currently, the method of choice for protection against sudden cardiac death for high-risk patients is ICD treatment. The CIDS study could prove a significant advantage of ICD treatment compared to amiodarone therapy. However, the survival advantages can be affected by the negative side effects of ICD therapy. The therapeutic survival function of the device is, in general, associated with a consciously experienced, at the same time completely unexpected and unprepared intracardial shock experience. Within the first year after implantation, 30-50% of patients with an ICD for secondary preventative indications experience such a shock. The average shock application frequency per year (under normal conditions) is about 2.5 shocks. The experience of one or more ICD shocks is significantly associated with a decrease in quality of life. Particularly the experiencing of five or more intracardial shocks approaches the patient's psychological resilience threshold. Partners and relatives of ICD patients are, on the other hand, often helpless with respect to the demands of and stress associated with the ICD technology. In current clinical practice, the involvement of the partners in the treatment of ICD patients is generally a coincidence and is generally not systematic or target-oriented. Improved involvement of relatives can contribute to an improved prognosis. Cardiologists caring for ICD patients should be aware of the specific psychological aspects of ICD technology, integrate these aspects into the guidance and care of patients, and be able to identify and address pathologically negative affects and crises in ICD patients.

Background: Preimplantation left ventricular dyssynchrony is considered a prerequisite for a beneficial response to cardiac resynchronization therapy (CRT). However, electrical dyssynchrony estimated by QRS duration (QRSd) on ECG has not been proven to be an optimal surrogate of mechanical dyssynchrony. We evaluated the correlation of mechanical dyssynchrony with QRSd as measured by signal-averaged electrocardiography (SAECG) in comparison with measurements based on conventional surface ECG and with onscreen measurements based on digital ECG. Methods: We included 49 consecutive patients with decompensated heart failure (40 men, aged 66.8 ± 9.5 years), New York Heart Association (NYHA) class II–IV, and LVEF ≤ 40%. QRSd was calculated by manual measurement of 12-lead ECG, on-screen measurement of computer-based ECG, and calculation of total ventricular activation time on SAECG. Results: Only 60.4% of the studied patients had QRS ≥ 120 ms based on measurements derived by SAECG compared to 69.4% by using on-screen measurement of computer-based ECG and 73.5% based on surface ECG (P = 0.041). Interventricular but not intraventricular delay was correlated with QRSd. The correlation of interventricular dyssynchrony with QRSd was stronger when measured by SAECG than by surface ECG (r = 0.45, P = 0.001 vs r = 0.35, P < 0.01). Among patients with ischemic cardiomyopathy, no significant correlation was demonstrated between mechanical dyssynchrony and QRSd. In nonischemic patients, interventricular delay was significantly correlated with QRSd measured by surface ECG (r = 0.45, P < 0.05) and SAECG (r = 0.46, P < 0.05). Conclusions: The use of SAECG results in different patient classification in wide QRS complex category as compared to surface ECG. Furthermore, QRSd measured by SAECG is correlated with interventricular but not intraventricular dyssynchrony in heart failure patients.

Recent large, prospective, multi-centre trials have demonstrated detrimental effects of unnecessary right ventricular pacing. This review summarizes the results of the major trials and sheds light on the potential mechanisms that cause the unfavourable outcome. Different programming strategies to avoid unnecessary pacing in dual chamber pacemakers and implantable cardioverters defibrillators - especially in respect of every day clinical practise - are discussed.

The programming of implantable cardioverter-defibrillators (ICDs) influences inappropriate shock rates. The aim of the study is to analyse rates of patients with appropriate and inappropriate shocks according to detection zones in the OPTION trial. All patients received dual chamber (DC) ICDs randomly assigned to be programmed either to single chamber (SC) or to DC settings including PARAD+ algorithm. In a post-hoc analysis, rates of patients with inappropriate and appropriate shocks were calculated for shocks triggered at heart rates ≥170 bpm (ventricular tachycardia zone) and at rates ≥200 bpm (ventricular fibrillation zone). In the SC group, higher rates of patients with total and inappropriate shocks were delivered at heart rates ≥170 bpm than at rates ≥200 bpm (total shocks: 21.1% vs. 16.6%; p = 0.002; inappropriate shocks: 7.6% vs. 4.5%, p = 0.016; appropriate shocks: 15.2% vs. 13.5%; p = n.s.). No such differences were observed in the DC group (total shocks: 14.3% vs. 12.6%; p = n.s.; inappropriate shocks: 3.9% vs. 3.6%; p = n.s.; appropriate shocks: 12.2% vs. 10.4%; p = n.s.). The higher frequency of patients with total shocks with SC settings than with DC settings that benefit from PARAD+ was driven by a higher percentage of patients with inappropriate shocks in the VT zone (170–200 bpm) in the SC population.

The implantation of a pacemaker is the therapy of choice for symptomatic bradyarrhythmias. The perioperative complication rate is low. This article gives an overview on possible complications, their avoidance and treatment.

Introduction: Complex fractionated atrial electrograms (CFAE) have been described as a new target for ablation of atrial fibrillation (AF). This prospective study evaluates the acute effects of CFAE ablation in patients with paroxysmal or persistent AF and analyzes the preferential anatomic sites where these effects occur. Methods and Results: Ablation of CFAE was performed in 66 symptomatic patients (mean age of 58 ± 12 years) with paroxysmal (n = 36) or persistent AF (n = 30). Termination or regularization of AF during ablation of CFAE was achieved in 56 of 66 patients (84%), with termination in 28 of 66 patients (42%) and regularization of AF in 28 of 66 patients (42%). Ablation of CFAE showed no effect in 10 of 66 patients (16%). Termination of AF occurred at 53 sites and AF regularization at 81 sites. The preferential sites of AF termination or regularization were found around the pulmonary veins (termination n = 15; regularization n = 22), at the anterior wall (termination n = 14; regularization n = 19) and at the interatrial septum (termination n = 8; regularization n = 17). Conclusion: Termination or regularization of AF was achieved acutely in 84% of patients by ablation of CFAE. The preferential sites of AF termination or regularization were found around the pulmonary veins, at the anterior wall of the LA and at the interatrial septum. These findings may have implications for future ablation concepts.