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Background: Implantable cardioverter defibrillators (ICD) prevent sudden cardiac death (SCD). Patients with end-stage renal disease (ESRD) requiring dialysis are at a very high risk of infection from cardiac implantable electronic device (CIED) implantation as well as mortality. In the present study, we compared the long-term complications and outcomes between subcutaneous ICD (S-ICD) and transvenous ICD (TV-ICD) recipients. Methods: In this retrospective analysis, we analyzed a total of 43 patients with ESRD requiring dialysis who received either a prophylactic S-ICD (26 patients) or a single right ventricular lead TV-ICD (17 patients) at seven experienced centers in Germany. Follow-up was performed bi-annually, at the end of which the data concerning comorbidities and, if applicable, reason for death were checked and confirmed with patients' general practitioner, nephrologist and cardiologist. Results: The median follow up duration was 95.6 months (range 42.8–126.3 months). Baseline characteristics were without noteworthy significant differences between groups. During follow-up (FU), there were significantly more device-associated infections (HR 8.72, 95% confidence interval (CI), 1.18 to 12.85, p < 0.05) and device-associated hospitalizations (HR 10.20, 95% CI 1.22 to 84.61, p < 0.001), as well as a higher cardiovascular mortality (HR 9.17, 95% CI 1.12 to 8.33, p < 0.05), in the TV-ICD group. The number of patients requiring hospitalization for any reason was significantly higher in the TV-ICD group (HR 2.59, 95% CI 1.12 to 6.41, p < 0.05). There was no significant difference in overall mortality (HR 1.92, 95% CI 0.96 to 6.15, p = 0.274). Conclusions: Our data suggest that, in this extended follow-up in seriously compromised renal patients on dialysis, the S-ICD patients have statistically fewer device infections and hospitalizations as well as lower cardiac mortality compared with the TV-ICD cohort. [ABSTRACT FROM AUTHOR]

Introduction: Dual‐coil leads (DC‐leads) were the standard of choice since the first nonthoracotomy implantable cardioverter/defibrillator (ICD). We used contemporary data to determine if DC‐leads offer any advantage over single‐coil leads (SC‐leads), in terms of defibrillation efficacy, safety, clinical outcome, and complication rates. Methods and Results: In the Shockless IMPLant Evaluation study, 2500 patients received a first implanted ICD and were randomized to implantation with or without defibrillation testing. Two thousand and four hundred seventy‐five patients received SC‐coil or DC‐coil leads (SC‐leads in 1025/2475 patients; 41.4%). In patients who underwent defibrillation testing (n = 1204), patients with both lead types were equally likely to achieve an adequate defibrillation safety margin (88.8% vs 91.2%; P = 0.16). There was no overall effect of lead type on the primary study endpoint of "failed appropriate shock or arrhythmic death" (adjusted HR 1.18; 95% CI, 0.86‐1.62; P = 0.300), and on all‐cause mortality (SC‐leads: 5.34%/year; DC‐leads: 5.48%/year; adjusted HR 1.16; 95% CI, 0.94‐1.43; P = 0.168). However, among patients without prior heart failure (HF), and SC‐leads had a significantly higher risk of failed appropriate shock or arrhythmic death (adjusted HR 7.02; 95% CI, 2.41‐20.5). There were no differences in complication rates. Conclusion: In this nonrandomized evaluation, there was no overall difference in defibrillation efficacy, safety, outcome, and complication rates between SC‐leads and DC‐leads. However, DC‐leads were associated with a reduction in the composite of failed appropriate shock or arrhythmic death in the subgroup of non‐HF patients. Considering riskier future lead extraction with DC‐leads, SC‐leads appears to be preferable in the majority of patients. [ABSTRACT FROM AUTHOR]

Background: Implantable defibrillators (ICD) are highly effective in reducing arrhythmia-related mortality. ICD shock therapy has been shown to increase psychological distress, health care utilization, and is associated with increased mortality. The Protecta ICDs (Medtronic Inc., Minneapolis, MN, USA) have algorithms designed to reduce unnecessary and inappropriate shock therapy. Methods and Results: The PainFree SmartShock™ Technology (PainFree SST) study is a prospective, multicenter, clinical trial with two consecutive phases, a premarket phase safety study and a postmarket phase effectiveness study. We report the results of the PainFree SST safety study. The premarket phase aimed to investigate safety in the first year postimplant, and to determine if the novel algorithms (T-wave discrimination, right ventricular lead noise discrimination and confirmation^) affect appropriate ventricular fibrillation (VF) detection. Patients (total: n = 246 [male 78%, mean age 63 year, primary prevention indication in 76%]) were implanted either with a Protecta XT dual-chamber ICD (n= 114 [46%]) or a defibrillator with cardiac resynchronization therapy (n = 132 [54%]). Appropriate VF detection was measured during VF induction at implantation when the novel algorithms were programmed ON. A two-second delay in VF detection was classified as clinically significant. No delay in VF detection was observed with all algorithms programmed ON. No unanticipated serious adverse device effects occurred during first year postimplant. Conclusion: The results of the premarket phase of the PainFree SST trial demonstrate the safety of the Protecta XT defibrillators. Detection of induced VF was not delayed with SmartShock™ algorithms ON. [ABSTRACT FROM AUTHOR]

Electrical storm (ES) is defined as the occurrence of ≥ three distinct episodes of ventricular arrhythmia (VA) in patients with implanted defibrillators within 24 h. Whereas conventional strategies for acute rhythm stabilization may be effective in some patients the occurrence of ES impairs survival and predicts recurrent VA. Catheter ablation in the setting of ES is complex and involves decisive strategies for individualized ablation approaches adapted to the patient's cardiac abnormalities. Success rates have been documented to be between 79 and 94% in larger studies and effective ablation improves survival and freedom from any VA. Ablation should be considered early in the treatment plan and availability may be improved by interhospital collaboration with highly experienced VA intervention centers. [ABSTRACT FROM AUTHOR]

Although a low-energy cardioversion (LEC) shock from an implantable cardioverter-defibrillator (ICD) can terminate ventricular tachycardia (VT), it frequently triggers ventricular fibrillation (VF) and is therefore not used in clinical practice. We tested whether a modified LEC shock with a very short duration (0.12-0.36 ms), termed 'field stimulus,' can terminate VT without triggering VF. In 13 sedated patients with implanted ICDs, we attempted to induce VT and to terminate the arrhythmias by field stimuli during hospital predischarge tests. In eight patients, 27 VT episodes were induced and treated with a total of 46 high-voltage (25-200 V) field stimuli, which terminated 11 VT episodes (41% efficacy) and never accelerated VT into VF. VT episodes slower than 230 beats per minute (bpm) (median rate) were terminated more successfully than faster arrhythmia episodes (69% vs 15%, P < 0.01). The strength of the field stimulus had no major influence on the effectiveness. We therefore postulate that suboptimal timing of field stimuli (delivered simultaneously with a sensed event in the right ventricular apex) was the main reason for failed VT terminations. A short (0.12-0.36 ms), high-voltage (50-100 V) field stimulus delivered from the shock coil of an implanted ICD system can safely terminate VT, especially for VT rates below 230 bpm. We believe that it would be reasonable to test the effectiveness of automatic field-stimulus therapy from implanted ICDs in VT episodes up to 230 bpm that are not susceptible to termination by antitachycardia pacing. (PACE 2010; 33:1540-1547) [ABSTRACT FROM AUTHOR]

Introduction: Short- and medium-term sinus rhythm (SR) rates after intraoperative radiofrequency ablation to treat permanent atrial fibrillation (AF) are well documented. Is rhythm success stable during a long-term follow-up? Methods and Results: A total of 130 patients who had undergone intraoperative radiofrequency cooled-tip endocardial ablation (SICTRA) of permanent AF (mean AF duration 6± 5 years) concomitant to open heart surgery more than 3 years ago were followed up using electrocardiogram (ECG), Holter-ECG, and echocardiography and compared with 12-month follow-up data. In 55% of patients, only the left atrium and in 45%, both atria were treated using SICTRA. Mitral valve replacement was performed in 21, mitral valve reconstruction in 25, aortic valve replacement in 13, CABG procedures in 51 (including 11 patients with additional mitral valve surgery), and complex procedures in 20 patients. Sixty-nine percent of patients (90/130) were in stable SR after a median period of 48 months, whereas 28% (36/130) were in AF and 3% (4/130) were in atrial flutter. In between the 12-month follow-up and the long-term follow-up, seven patients converted to AF after having documented SR, two patients converted to typical right atrial flutter after being in SR, and two patients from AF to left atrial macroreentry. After left and biatrial SICTRA, SR rates were comparable (73% vs 66%, P = 0.45). Echocardiography revealed 73% of patients in SR to have effective left atrial contraction. Conclusions: SICTRA restores long-term stable SR in 69% of all patients. Nine percent of patients reconverted back to atrial arrhythmia after having documented SR at 12 months. [ABSTRACT FROM AUTHOR]

Introduction: A low-energy (≤ 4 J) cardioversion shock (LEC) either terminates reentrant ventricular tachycardia (VT) or accelerates it to ventricular fibrillation (VF). Optimization of the duration and amplitude of LEC shocks could improve the success rate of VT termination without VF induction. Methods and Results: In order to learn how LEC shocks may be optimized, we used an animal model to compare the strength-duration curve for VF induction and the strength-duration curve for cardiac stimulation via the shock coil. Conventional implantable cardioverter-defibrillator (ICD) leads were implanted in 12 narcotized pigs from 20 kg to 25 kg in weight. Stimulation, VF induction, and defibrillation pulses were delivered by custom-designed stimulators at preset pulse durations and amplitudes. The corresponding hyperbolic strength-duration curves were constructed using the least-squares fit method and averaged for all the animals. The mean chronaxie for stimulation via the shock coil of 0.23 ms was significantly shorter than both defibrillation (4.8 ms) and VF induction (3.1 ms) chronaxie values. At a shock duration of 0.3 ms or less, the mean VF-induction threshold amplitude exceeded 300 V. Conclusion: It may be reasonable to study whether LEC pulses from 0.25 ms to 0.30 ms in duration and up to 250 V in amplitude would increase therapeutic yield in VT termination without VF induction in humans. Contrary to the current belief, the discrepancy between defibrillation and stimulation chronaxie is not caused by different electrode size. We postulate that the time constant of the fast sodium channel reactivation may be the underlying reason. [ABSTRACT FROM AUTHOR]

Aims: We evaluated the feasibility of the TULIP (Threshold test using Upper Limit during ImPlantation) protocol, which was designed to provide a confirmed, low defibrillation energy value during implantable cardioverter defibrillator (ICD) implantation with only two induced ventricular fibrillation (VF) episodes. [ABSTRACT FROM PUBLISHER]

Aims: We performed a randomized, double blind, crossover study of cardiac contractility modulation (CCM) signals in heart failure patients. [ABSTRACT FROM PUBLISHER]

Catheter ablation of atrial fibrillation (AF) may modify the atrial substrate and isolate AF triggers but reversing and preventing further atrial remodeling should be attempted specific postinterventional medication regimen. Inhibition of the renin-angiotensin system may be integral in interfering with structural remodeling of the atria during AF. Specifically, angiotensin receptor blocker - owing to their high local atrial effectiveness in blocking angiotensin-mediated pathways - may help to improve rhythm outcome after AF interventions. Optimum success of an aggressive AF intervention can only be achieved when patients selection for specific postinterventional pharmacological agents is optimized. [ABSTRACT FROM AUTHOR]

Introduction: Surgical treatment of atrial fibrillation (AF) is gaining widespread acceptance. However, therapeutic modalities for secondary regular atrial tachycardia are still empiric. Methods and Results: After linear atrial cooled-tip radiofrequency ablation (SICTRA) during cardio-surgical procedures to cure permanent AF, patients with regular atrial tachycardia were identified. Invasive electrophysiology including electroanatomic mapping was performed. Catheter ablation was directed to suppress atrial arrhythmia depending on activation mapping findings. Follow-up was performed after 3 months and then after every 6 months. Of 238 patients, 12 (5.0%) were identified with regular secondary arrhythmias (12 ± 7 months after surgery) including 9 (3.8%) with persistent forms originating from the right atrium (RA) in six (66%) (isthmus-dependent macroreentry in 4, incisional macroreentry in 1, and RA ectopy in 1). All patients with RA origin of the tachycardia were successfully ablated. Two patients had left atrial (LA)-macroreentry circling around the mitral valve indicating insufficiency of the intraoperative ablation procedure: one patient was successfully ablated within the LA isthmus, in the other patient no complete conduction block could be induced. One patient had LA-macroreentry degenerating into AF, and ablation was not performed. During follow-up (9 ± 4 months), no recurrences of atrial tachycardias were documented after successful ablation. Conclusions: Persistent regular “secondary” arrhythmia occurred in 3.8% (9/238) of patients after SICTRA to treat permanent AF. Predominantly (67%; 6/9), the arrhythmia was located in the RA mostly incorporating the RA-isthmus. Catheter ablation was highly effective for RA tachycardia (100%). In three cases (33%), LA-macroreentry was documented and catheter ablation was successful in only one patient (overall success 78%). [ABSTRACT FROM AUTHOR]

Introduction: Catheter ablation of ventricular tachycardia (VT) in remote myocardial infarction (MI) often requires excessive mapping procedures. Documentation of the electrical substrate via electrogram amplitude may help to identify regions of altered myocardium resembling exit areas of reentrant VTs. Methods and Results: A patient with multiple symptomatic monomorphic VTs (biventricular ICD, remote MI) underwent electroanatomic substrate mapping (CARTO™) for VT ablation. Regions of scar (bipolar electrogram amplitudes ≤0.5 mV), normal myocardium (≥1.5 mV), and “altered” myocardium (0.5–1.5 mV) were identified. Ablation was directed to regions with “altered” myocardium based on pace map correlation. After ablation the clinical VT did not reoccur. The patient died due to worsening of heart failure 7 days afterward. During postmortal evaluation specified sites of electroanatomic mapping were correlated to histopathological findings. Annotated scar areas were documented to consist of areas with massive fibrosis (≥80% of mural composition). Ablations were found to span through regions with intermediate fibrosis (21–79%) mapped as “altered” myocardium. Ablation produced transmural coagulation necrosis of mesh-like fibrotic tissue with interspersed remnants of myocardial cells up to a maximum depth of 7.0 mm. Subendocardial intramural bleedings were universal findings 7 days after ablation. Conclusions: Electroanatomic substrate mapping for VT ablation sufficiently identified regions of scar and normal myocardium. Regions with bipolar electrogram amplitudes between 0.5 and 1.5 mV were found to correlate to areas of “intermediate” fibrosis (21–79%) with only remnant strands of myocardial cells and were identified as target region for ablation. Cooled-tip endocardial radiofrequency ablation lead to transmural coagulation necrosis up to a depth of 7.0 mm. [ABSTRACT FROM AUTHOR]

Aims This study was undertaken to evaluate if a history of episodes of atrial fibrillation (AF) has an effect on survival in patients (pts) with implanted cardioverter defibrillators (ICD). Methods and results Retrospective analysis of baseline characteristics, medication and endpoints in pts receiving a dual-chamber ICD comparing pts without (group 1: n=291) and with a history of AF (group 2: n=68). Conclusion ICD-patients with a history of AF had a higher than average risk of death early after implantation and after device-detected episodes of AF. [ABSTRACT FROM PUBLISHER]

VAN HEMEL, N.M.,et al.: Form Analysis Using Digital Signal Processing Reliably Discriminates Far-Field R Waves From P Waves. The correct detection of atrial arrhythmias by pacemakers is often limited by the presence of far-field R waves (FFRWs) in the atrial electrogram. Digital signal processing (DSP) of intracardiac signals is assumed to provide improved discrimination between P waves and FFRWs when compared to current methods. For this purpose, 100 bipolar and unipolar intracardiac atrial recordings from 31 patients were collected during pacemaker replacement and used for the off-line application of a novel DSP algorithm. Digital processing of the atrial intracardiac electrogram (IEGM) signals (8 bit, 800 samples/s) included filtering and calculation of the maximum amplitude and slope of the detected events. The form parameter was calculated, being the sum of the most negative value of the amplitude and that of the slope of the detected event. The algorithm collects form parameter data of P waves and FFRWs and composes histograms of these data. A sufficiently large gap between the FFRW and P wave histograms allows discrimination of these two signals based on form parameters. Three independent observers reviewed the reliability of classification with this algorithm. Sensitivity and specificity of FFRW detection were 99.63% and 100%, respectively, and no P waves were falsely classified. It can be concluded that this novel DSP algorithm shows excellent discrimination of FFRWs under off-line conditions and justify the implementation of this algorithm in future pacemakers for real-time discrimination between P waves and FFRWs. This method prevents false mode switching and allows correct and immediate intervention pacing for atrial tachyarrhythmias.(PACE 2004; 27:1615–1624) [ABSTRACT FROM AUTHOR]

Study Objectives: To assess the practical application and safety of prehospital antithrombotic therapy with the glycoprotein (GP) IIb/IIIa inhibitor eptifibatide for patients with suspected acute coronary syndrome (ACS) or myocardial infarction (MI).Design: Open-labeled pilot study. Patients with typical chest pain who were seen within 6 h of the onset of symptoms were enrolled in the mobile emergency ambulance. Patients were stratified by even/uneven days to receive standard treatment or standard treatment plus an IV bolus of eptifibatide (180 microg/kg body weight) followed by a continuous eptifibatide infusion (2 microg/kg/min). The main outcome measurement was a combination of prehospital or in-hospital death, reinfarction, revascularization of target vessels, and major bleeding complications.Results: A total of 356 patients (age range, 29 to 75 years; women, 24.7%) were included in the analysis. On admission to the hospital, the diagnosis of ACS or MI was confirmed in approximately 60% of patients, and alternative diagnoses were made in 40% of patients. The rates of complications, including fatal and nonfatal complications occurring during transportation and during subsequent hospitalization, were similar in both study groups. The primary end point occurred in 11.8% of patients in the control group, and in 9.6% of those in the eptifibatide group (difference not significant).Conclusion: The prehospital administration of the GP IIb/IIIa inhibitor eptifibatide is feasible and safe in patients with clinically suspected ACS and MI. The benefit of this treatment has yet to be established in a large-scale multicenter study. [ABSTRACT FROM AUTHOR]

Study objectives: To assess the practical application and safety of prehospital antithrombotic therapy with the glycoprotein (GP) IIb/IIIa inhibitor eptifibatide for patients with suspected acute coronary syndrome (ACS) or myocardial infarction (MI). Design: Open-labeled pilot study. Patients with typical chest pain who were seen within 6 h of the onset of symptoms were enrolled in the mobile emergency ambulance. Patients were stratified by even/uneven days to receive standard treatment or standard treatment plus an IV bolus of eptifibatide (180 μg/kg body weight) followed by a continuous eptifibatide infusion (2 μg/kg/min). The main outcome measurement was a combination of prehospital or in-hospital death, reinfarction, revascularization of target vessels, and major bleeding complications. Results: A total of 356 patients (age range, 29 to 75 years; women, 24.7%) were included in the analysis. On admission to the hospital, the diagnosis of ACS or MI was confirmed in approximately 60% of patients, and alternative diagnoses were made in 40% of patients. The rates of complications, including fatal and nonfatal complications occurring during transportation and during subsequent hospitalization, were similar in both study groups. The primary end point occurred in 11.8% of patients in the control group, and in 9.6% of those in the eptifibatide group (difference not significant). Conclusion: The prehospital administration of the GP IIb/IIIa inhibitor eptifibatide is feasible and safe in patients with clinically suspected ACS and MI. The benefit of this treatment has yet to be established in a large-scale multicenter study. [ABSTRACT FROM AUTHOR]

BACKGROUND: Many different stent types are available for intracoronary placement. No clinical trial has demonstrated clearly the superiority of any stent design over another. METHODS: This study was designed to analyze clinical and angiographic results after using intracoronary PURA-VARIO (Devon Medical, Hamburg, Germany) (PUVA) stents. A total of 306 implanted stents were investigated in a series of 217 unselected patients (61.2 ± 10.7 years, 74.3% male). Stenting was performed electively and during acute coronary syndromes. Stents were manually mounted on angioplasty balloons and expanded in the target lesion. Angiographic measurements were carried out by quantitative coronary angiography. RESULTS: Stenting was successful in 214/217 patients (98.8%). During hospitalization (median three days) 206 patients (94.9%) were free from adverse cardiac events. Stent thrombosis occurred in five patients (2.3%), Q-wave infarction in one (0.5%) and urgent percutaneous target vessel revascularization in four (1.8%). Follow-up angiography, performed in 170 patients (78.3%) showed a restenosis (≥50% diameter stenosis) in 44/170 patients (25.9%), requiring angioplasty in 29 (17.2%). A surgical revascularization was recommended in 13 patients (7.6%). One patient died during follow-up from an unknown cause; however, sudden cardiac death was most likely. CONCLUSIONS: PUVA stents are characterized by a high level of safety and efficacy. Clinical and angiographic results are comparable with those of other approved stents. (Int J Cardiovasc Intervent 2003; 5: 156-160) [ABSTRACT FROM AUTHOR]

Introduction: Patients with bradycardia requiring permanent pacing frequently suffer from additional atrial tachyarrhythmias (ATs). This study evaluated the safety and efficacy of atrial antitachycardia pacing (ATP) and the performance of pacing for AT prevention implemented into a new pacemaker. Methods and Results: In patients with conventional indications for permanent pacing, an investigational DDDRP pacemaker (Medtronic AT500, model 7253) was implanted. The primary study objectives were to determine the safety of overall device functioning and its efficacy in terminating spontaneous AT. A secondary endpoint was to determine the reliability of AT detection. Pacemaker memory functions were used to analyze the impact of dedicated pacing algorithms on AT prevention. In 33 European and Canadian centers, 325 patients were enrolled (mean follow-up 2.3 ± 1.3 months). Complication-free survival at 3 months was 88%. In 2,145 episodes stored with atrial electrograms, AT detection was confirmed in 97%. The algorithm for continuous overdrive pacing increased the percentage of atrial pacing to 97%. After ATP activation, 16,683 of 52,468 AT episodes were treated (120 patients). Of these, 8,903 episodes (53%) were terminated successfully by ATP. No proarrhythmic effect of preventive pacing or atrial ATP was observed. Preventive pacing algorithms increased the median percentage of atrial pacing from 62% to 97%. However, the number of AT/AF (atrial fibrillation) episodes (4.1 vs 4.1 per patient per day) and the time in AT/AF (13.7% vs 12.8%) was not significantly different before and after activation of preventive pacing. Conclusion: DDDRP pacing with a new system for AT therapy was safe and associated with successful pace-termination of AT in 53% of episodes. Preventive pacing and atrial ATP algorithms represent two new functions that can be implemented safely into pacemaker systems for nonpharmacologic treatment of ATs in patients requiring pacemaker therapy. [ABSTRACT FROM AUTHOR]

Copyright of Herz is the property of Springer Nature and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

Primary success rates, and the angiographic and clinical outcome after percutaneous coronary intervention, are influenced by many different factors. Clinical features and morphologic characteristics of the target lesion are important. Also, interventionally caused endothelial trauma may trigger atherogenetic and procoagulatory factors leading to intraluminal thrombosis. The study population consisted of 228 consecutive, unselected patients with symptomatic coronary artery disease or exercise-induced myocardial ischemia and coronary artery stenoses eligible for percutaneous intervention. We analyzed different clinical, morphological, and laboratory (total cholesterol, high-density lipoprotein-cholesterol, low-density lipoprotein-cholesterol, triglycerides, fibrinogen) features in those patients with adverse cardiac events (stent thrombosis, myocardial infarction, urgent target vessel revascularization, death) after primary successful coronary artery stenting, compared with a control group without adverse events. In the group with adverse cardiac events we found a significantly higher level of fibrinogen compared with the control group. Other laboratory data and clinical characteristics were not significantly different between the two groups. The study shows a possible association between hyperfibrinogenemia and adverse cardiac events after intracoronary stenting. In clinical practice, the potential role of elevated levels of fibrinogen in an unfavorable outcome after percutaneous coronary interventions should be considered when planning coronary artery stenting. [ABSTRACT FROM AUTHOR]

Copyright of Herzschrittmachertherapie und Elektrophysiologie is the property of Springer Nature and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)