Safety and efficacy of paediatric outpatient radiofrequency catheter ablations.

AIMS: Radiofrequency catheter ablation (RFA) is a frequently performed procedure as treatment for supraventricular tachycardia in children >4 years of age. The aim of this study was to evaluate the safety and efficacy of the paediatric outpatient RFA procedure. METHODS: Between 2002 and 2008, 271 RFAs were analyzed. Exclusion criteria for outpatient procedures amongst others were distance to home >1h and anticipated complex RFA in congenital heart disease. All patients underwent pre- and post-procedural echocardiography and electrocardiogram. Patient discharge was within 6h after conclusion of RFA. Parental follow-up phone calls the day after the procedure were performed. All patients were seen in outpatient clinics 1 month after RFA. RESULTS: A total of 97/271 (37%) patients aged 13.6 (4.8-18.0) years qualified for outpatient RFA. Accessory pathway ablations (n=50) and atrioventricular node modifications (n=39) were the most common RFAs. RFA was successful in 94/97 (97%) patients. Post-procedural echocardiography and electrocardiogram did not reveal any RFA related complications. Anaesthetic adverse events, predominantly post-interventional nausea and vomiting, were observed in 10 (10%) patients. Hospital discharge within 6h was practicable in all but one due to ongoing nausea. Follow-up phone calls did not reveal further complications. Recurrence of tachycardia after successful RFA was observed in 6 of 94 (6%) patients and prompted re-intervention in 4. CONCLUSIONS: Outpatient RFA is feasible and safe in selected paediatric patients. No RFA related complication was observed. Anaesthetic adverse events were nausea and vomiting due to general anaesthesia. Success rate and recurrence rate of tachycardia were favourable after outpatient RFA.

Interaction of vitamin K antagonists with heparin affect monitoring by activated clotting times.

BACKGROUND: Unfractionated heparin is recommended during atrial fibrillation (AF) ablation to achieve activated clotting time (ACT) above 250-300 s to prevent clot. Many patients on therapeutic international normalised ratio (INR) undergo AF ablation procedures; however, it is unknown whether they require less heparin to achieve similar ACT levels. METHODS: During AF ablation, the ACT was measured before and 10 min after administration of i.v. unfractionated heparin in patients with and without anticoagulation. The association of INR, heparin, pre-procedure ACT and body weight with ACT after heparin administration was tested using multivariable linear regression models. RESULTS: The subjects of this study were 149 patients undergoing AF ablation, among them 40 (27%) with subtherapeutic INR < 2, 79 (53%) with an INR between 2 and 3, and 30 (20%) patients with INR > 3. Baseline ACT was associated with INR (r = 0.33, p < 0.001). After a mean of 8,685 +/- 2,015 U (range, 5,000-15,000 IU) unfractionated heparin, univariate predictors of ACT were baseline INR (p < 0.001), heparin dose (p = 0.012) and baseline ACT (p = 0.027). In the multivariable model, baseline INR (part r = 0.64, p < 0.001) and heparin dose (part r = 0.33, p < 0.001) strongly predicted post-heparin ACT. Estimated from the regression model, the heparin dose reductions by approximately one third in those with an INR of 2-3 and by at least two thirds in those with an INR above 3 may be favourable. Over the following 3 months, no thromboembolism and acute bleeding were observed. CONCLUSION: The INR was the strongest predictor of post-heparin ACT, even more important than the heparin dose itself. The reduction of heparin dose by one third if INR is between 2-3 and by two thirds if INR is above 3 may be favourable.

Sinus node disease and arrhythmias in the long-term follow-up of former professional cyclists.

AIMS: Significant brady- and tachyarrhythmias may occur in active endurance athletes. It is controversial whether these arrhythmias do persist after cessation of competitive endurance training. METHODS AND RESULTS: Among all 134 former Swiss professional cyclists [hereafter, former athletes (FAs)] participating at least once in the professional bicycle race Tour de Suisse in 1955-1975, 62 (46%) were recruited for the study. The control group consisted of 62 male golfers matched for age, weight, hypertension, and cardiac medication. All participants were screened with history, clinical and echocardiographic examination, ECG, and 24 h ECG. The time for the last bicycle race of FAs was 38 +/- 6 years. The mean age at examination was 66 +/- 6 years in controls and 66 +/- 7 years in FAs (P = 0.47). The percentage of study participants with >4 h current cardiovascular training per week was identical. QRS duration (102 +/- 20 vs. 95 +/- 13 ms, P = 0.03) and corrected QTc interval (416 +/- 27 vs. 404 +/- 18, P = 0.004) were longer in FAs. There was no significant difference in the number of isolated atrial or ventricular premature complexes, or supraventricular tachycardias in the 24 h ECG; however, ventricular tachycardias tended to occur more often in FAs than in controls (15 vs. 3%, P = 0.05). The average heart rate was lower in FAs (66 +/- 9 vs. 70 +/- 8 b.p.m.) (P = 0.004). Paroxysmal or persistent atrial fibrillation or flutter was reported more often in FAs (P = 0.028). Sinus node disease (SND), defined as bradycardia of <40 b.p.m. (10 vs. 2%), atrial flutter (6 vs. 0%), pacemaker for bradyarrhythmias (3 vs. 0%), and/or maximal RR interval of >2.5 s (6 vs. 0%), was more common in FA (16%) than in controls (2%, P = 0.006). Observed survival of all FAs was not different from the expected. CONCLUSIONS: Among FAs, SND occurred significantly more often compared with age-matched controls, and there is trend towards more frequent ventricular tachycardias. Further studies have to evaluate prevention of arrhythmias with extreme endurance training, the necessity of regular follow-up of heart rhythm, and management of arrhythmias in former competitive endurance athletes.

In vivo heating of pacemaker leads during magnetic resonance imaging.

AIMS: Magnetic resonance imaging (MRI) is well established as an important diagnostic tool in medicine. However, the presence of a cardiac pacemaker is usually regarded as a contraindication for MRI due to safety reasons. In this study, heating effects at the myocardium-pacemaker lead tip interface have been investigated in a chronic animal model during MRI at 1.5 Tesla. METHODS AND RESULTS: Pacemaker leads with additional thermocouple wires as temperature sensors were implanted in nine animals. Temperature increases of up to 20 degrees C were measured during MRI of the heart. Significant impedance and minor stimulation threshold changes could be seen. However, pathology and histology could not clearly demonstrate heat-induced damage. CONCLUSIONS: MRI may produce considerable heating at the lead tip. Changes of pacing parameters due to MRI could be seen in chronic experiments. Potential risk of tissue damage cannot be excluded even though no reproducible alterations at the histological level could be found.

Diagnosis of sleep-related breathing disorders by visual analysis of transthoracic impedance signals in pacemakers.

BACKGROUND: Minute ventilation sensors of cardiac pacemakers measure ventilation by means of transthoracic impedance changes between the pacemaker case and the electrode tip. We investigated whether this technique might detect sleep-related breathing disorders. METHODS AND RESULTS: In 22 patients, analog waveforms of the transthoracic impedance signal measured by the pacemaker minute ventilation sensor over the course of a night were visualized, scored for apnea/hypopnea events, and compared with simultaneous polysomnography. Analysis of transthoracic impedance signals correctly identified the presence or absence of moderate to severe sleep apnea (apnea/hypopnea index, AHI >20 h(-1)) in all patients (receiver operating characteristics, ROC=1.0). The ROC for AHI scores of > or =5 h(-1) and > or =10 h(-1) showed an area under the curve of 0.95, P<0.005, and 0.97, P<0.0001, respectively. Accuracy over time assessed by comparing events per 5-minute epochs was high (Cronbach alpha reliability coefficient, 0.85; intraclass correlation, 0.73). Event-by-event comparison within +/-15 seconds revealed agreement in 81% (kappa, 0.77; P<0.001). CONCLUSIONS: Detection of apnea/hypopnea events by pacemaker minute ventilation sensors is feasible and accurate compared with laboratory polysomnography. This technique might be useful to screen and monitor sleep-related breathing disorders in pacemaker patients.

Effects of acute systemic endothelin receptor blockade on cardiac electrophysiology in vivo.

BQ-123, a selective endothelin-A receptor antagonist, has been demonstrated to suppress arrhythmias. However, the role of physiologic levels of endogenous endothelin-1 (ET-1) with respect to electrophysiologic properties of the heart is unknown. BQ-123 (0.45, 0.9, 1.8, 3.6, 7.2, and 14.4 microg/kg/min; n = 10) or saline (control, n = 5) was administered IV for 15 minutes of continuous-rate infusion at incremental doses to anesthetized normal pigs. BQ-123 had no effect on PR and QT interval, QRS duration, intraatrial and AV nodal conduction time as well as the atrial, AV nodal, and ventricular effective refractory periods. As compared with baseline, BQ-123 at 7.2 and 14.4 microg/kg/min caused an increase in heart rate (99 +/- 17 versus 110 +/- 14 and 118 +/- 14 bpm, respectively; P < 0.05), shortened sinus node recovery time (818 +/- 165 versus 641 +/- 69 and 609 +/- 74 milliseconds, respectively; P < 0.05) and decreased mean arterial pressure at 14.4 microg/kg/min (95 +/- 18 versus 80 +/- 11 mm Hg; P < 0.05). We conclude that in the normal pig, physiologic levels of ET-1 have no effect on conduction properties of atrial, AV nodal, or Purkinje fibers. However, antagonism of ET-1 by BQ-123 unmasks the effect of ET-1 on maintenance of vasomotor tone, which in turn may affect heart rate and sinus node automaticity in the intact pig.

Ibutilide versus amiodarone in atrial fibrillation: a double-blinded, randomized study.

OBJECTIVE: Ibutilide, a class III antiarrhythmic drug, has been shown to convert atrial fibrillation to sinus rhythm more rapidly than procainamide or sotalol. Our objective was to compare the efficacy and safety of ibutilide and amiodarone in patients after cardiac surgery. DESIGN: Prospective, randomized, double-blinded study. SETTING: Intensive care unit of a university hospital. PATIENTS: Forty adults with an onset of atrial fibrillation within 3 hrs after admission. INTERVENTIONS: Before the administration of antiarrhythmic drugs, a 24-hr Holter electrocardiograph was attached. Patients in the ibutilide group received ibutilide 0.008 mg/kg body weight over 10 mins; treatment was repeated if atrial fibrillation or flutter persisted. If sinus rhythm was not achieved within 4 hrs, amiodarone 5 mg/kg was administered over 30 mins, followed by amiodarone 15 mg/kg over 24 hrs. Patients in the amiodarone group received amiodarone 5 mg/kg over 30 mins, followed by amiodarone 15 mg/kg over 24 hrs if atrial fibrillation or flutter continued. MEASUREMENTS AND MAIN RESULTS: Within the first 4 hrs, atrial fibrillation was converted in nine of 20 patients (45%) in group ibutilide and in ten of 20 patients (50%) in group amiodarone (not significant). Mean time for conversion overall was 385 mins in group ibutilide and 495 mins in group amiodarone (not significant). In group amiodarone, the protocol was discontinued in two patients because of severe arterial hypotension. Atrial fibrillation recurred in 11 of 20 patients (55%) in group ibutilide and in seven of 20 patients (35%) in group amiodarone (not significant). Ventricular arrhythmia did not occur during the first 24 hrs of the protocol. CONCLUSIONS: Ibutilide has no significant advantage over amiodarone for the conversion of atrial fibrillation to sinus rhythm in either time to conversion or conversion overall, but severe hypotension was not seen with ibutilide.

Impact of automatic adjustment of stimulation outputs on pacemaker longevity in a new dual-chamber pacing system.

INTRODUCTION: Automatic capture verification using the Autocapture (AC) feature enabled by paced evoked response detection and delivery of high energy back-up pulses intends to increase patient safety. Furthermore, adjustment of stimulation outputs can save energy and potentially improve pacemaker (PM) longevity. The purpose of this study was to evaluate the theoretical longevity of a new dual chamber PM with the integrated AC feature (Affinity DR, St. Jude Medical) in comparison to the longevity of a previous model from the same manufacturer without AC (Trilogy DR). METHOD: Affinity PMs were implanted in 16 patients and connected to a compatible lead with low polarization properties. AC was activated when the evoked response was significantly higher than the polarization voltage. Theoretical PM longevity was calculated with and without AC during follow-up. The measured and calculated values were compared to measurements in 19 patients, who consecutively received Trilogy-PMs during the same time period. RESULTS: In only one patient the evoked response was not adequate, and as a result, AC was not programmed. The calculated longevity of the Affinity-PMs 79 +/- 28 days after implantation was significantly higher in comparison to the Trilogy-PMs (Affinity-PMs: 8.9 +/- 1.2 years without and 9.5 +/- 1.1 years with AC; Trilogy-PMs: 6.5 +/- 0.8 years) (p < 0.005). CONCLUSION: The AC feature is an optional algorithm that can be activated in most patients and it significantly prolongs predicted battery longevity due to automatic adjustment of stimulation outputs.

Impact of fusion avoidance on performance of the automatic threshold tracking feature in dual chamber pacemakers: a multicenter prospective randomized study.

The Autocapture algorithm enables automatic capture verification on a beat-by-beat basis by recognizing the evoked response signal following each pacemaker stimulus. The algorithm intends to increase patient safety while decreasing energy consumption. However, the occurrence of fusion beats, particularly during dual chamber pacing, may limit the energy saving effect of Autocapture. The aim of this multicenter, prospective, randomized study was to evaluate the impact of the Fusion Avoidance (FA) algorithm on the incidence of fusion beats. Thirty-eight patients (mean age 69 +/- 13 years) with intrinsic AV conduction who were implanted with an Affinity DR were studied. After programming a PV/AV delay of 120/190 ms, patients were randomized to FA On or Off. Each group was further randomized with respect to activation of the AutoIntrinsic Conduction Search (AICS) algorithm. The total number of beats, ventricular paced beats, fusion beats, backup pulses, and threshold searches were analyzed from 24-hour Holter recordings. The number of total beats was comparable in both FA groups. The number of total ventricular paced beats, fusion beats, backup pulses, and threshold searches were significantly reduced in the FA On group (% reduction: 68% P < 0.001, 75% P < 0.01, 95% P < 0.01, and 94% P < 0.05, respectively). The number of ventricular paced beats with full capture was significantly reduced when AICS was activated (P < 0.05). In conclusion, the FA algorithm substantially reduces the amount of ventricular paced beats, fusion beats, unnecessary backup pulses and threshold searches, and therefore, provides added benefits in energy saving obtained by Autocapture.

Pacemaker reed switch behavior in 0.5, 1.5, and 3.0 Tesla magnetic resonance imaging units: are reed switches always closed in strong magnetic fields?

MRI is established as an important diagnostic tool in medicine. However, the presence of a cardiac pacemaker is usually regarded as a contraindication for MRI due to safety reasons. The aim of this study was to investigate the state of a pacemaker reed switch in different orientations and positions in the main magnetic field of 0.5-, 1.5-, and 3.0-T MRI scanners. Reed switches used in current pacemakers and ICDs were tested in 0.5-, 1.5-, and 3.0-T MRI scanners. The closure of isolated reed switches was evaluated for different orientations and positions relative to the main magnetic field. The field strengths to close and open the reed switch and the orientation dependency of the closed state inside the main magnetic field were investigated. The measurements were repeated using two intact pacemakers to evaluate the potential influence of the other magnetic components, like the battery. If the reed switches were oriented parallel to the magnetic fields, they closed at 1.0 +/- 0.2 mT and opened at 0.7 +/- 0.2 mT. Two different reed switch behaviors were observed at different magnetic field strengths. In low magnetic fields (< 50 mT), the reed switches were closed. However, in high magnetic fields (> 200 mT), the reed switches opened in 50% of all tested orientations. No difference between the three scanners could be demonstrated. The reed switches showed the same behavior whether they were isolated or an integral part of the pacemakers. The reed switch in a pacemaker or an ICD does not necessarily remain closed in strong magnetic fields at 0.5, 1.5, or 3.0 T and the state of the reed switch may not be predictable with certainty in clinical situations.

Rate responsive pacing using transthoracic impedance minute ventilation sensors: a multicenter study on calibration stability.

Previous studies showed that transthoracic impedance minute ventilation (IMV), as measured by a pacemaker sensor, is closely correlated to actual minute ventilation (VE) determined by standard methods. The aim of this study was to analyze the changes in the calibration between IMV and VE at rest and during exercise over time. Fifteen patients (age 60 +/- 13 years) with Medtronic Kappa 400 pacemakers completed a baseline visit followed by two visits separated by 1 month and 1 week, respectively. In each patient, VE (L/min) was monitored at rest in the supine and sitting positions and during graded bicycle ergometer exercise using a standard cardiopulmonary metabolic gas analysis system with simultaneous recording of IMV (omega/min) using DR-180 extended telemetry monitors. Calibration at rest was defined as the ratio of IMV to VE, calculated from 1-minute average values in the supine and sitting positions. Calibration during bicycle exercise was defined as intercept (IMV value at VE = 10 L/min-typical VE value at beginning of exercise), and slope of the IMV/VE regression line. The calibration of IMV showed individual variability over time. The magnitude (absolute value) of observed fractional changes in calibration at 1 month was 0.23 +/- 0.20 (rest-supine), 0.20 +/- 0.15 (rest-sitting), 0.18 +/- 0.19 (exercise-intercept), 0.28 +/- 0.35 (exercise-slope), and 0.18 +/- 0.15, 0.15 +/- 0.09, 0.28 +/- 0.39, and 0.27 +/- 0.15, respectively, at 1 week. The magnitude of change at 1 month was not statistically different from the magnitude of change at 1 week. In conclusion, the calibration of IMV, as measured by a pacemaker sensor, versus actual VE may demonstrate variability. However, this study also suggests that the observed changes are not cumulative over time. These results have implications for patient monitoring applications using these sensors and for development of future pacemaker rate response algorithms.