CoolLoop® First: A First In Man Study To Test A Novel Circular Cryoablation System In Paroxysmal Atrial Fibrillation.

INTRODUCTION: Pulmonary vein (PV) isolation is the mainstay of catheter treatment of paroxysmal atrial fibrillation (AF). The CoolLoop® cryoablation catheter (AFreeze® GmbH; Innsbruck, Austria) was developed to create wide and complete circular lesions around the PVs. In this study we evaluated feasibility and safety of this novel ablation system in humans. METHODS: 10 patients (6M/4F; 57.6±7.6y) with paroxysmal AF were included in 2 referral centers. The CoolLoop® catheter was positioned at each PV antrum using a steerable transseptal sheath. Subsequently, 2-6 double-freezes over 5min were performed at each vein and PV-isolation was assessed thereafter using a circular mapping catheter. During cryoablation of the right PVs, pacing was used to monitor phrenic nerve function. RESULTS: The CoolLoop® catheter could be successfully positioned at each PV. A mean of 5.6±1.8 cryoablations were performed in the LSPV, 5.2±1.6 in the LIPV, 6.3±2.5 in the RSPV and 5.4±1.6 in the RIPV, respectively. Mean procedure time was 251±60min and mean fluoroscopy time was 44.0±13.2min. 6 / 10 LSPV, 6 / 10 LIPV, 5 / 10 RSPV and 6 / 10 RIPV could be isolated exclusively using the novel cryoablation system. One patient developed groin hematoma and a brief episode of ST-elevation due to air embolism was observed in another subject. No other clinical complications occurred during 3 months of follow up. CONCLUSIONS: PV-isolation for paroxysmal atrial fibrillation using the CoolLoop® catheter is feasible and appears safe. Clinical long term efficacy still needs to be evaluated and will be compared with established catheters used for AF ablation.

Elevated γ-glutamyltransferase in implantable cardioverter defibrillator patients.

BACKGROUND: Elevated γ-glutamyltransferase (GGT) is a new risk factor for cardiovascular diseases, but its impact on ventricular tachyarrhythmia occurrence and survival in patients with an implantable cardioverter defibrillator (ICD) is unknown. METHODS AND RESULTS: Considering that GGT levels are gender-dependent, female ICD recipients were excluded from our database because of the low incidence of events. In a retrospective analysis, appropriate ICD therapy (both shocks and antitachycardia pacing due to ventricular tachyarrhythmias) occurred in 31.9% of 320 male patients who had received an ICD for primary prevention (median follow-up of 2.3 years), and in 55.1% of 423 male patients who had received an ICD for secondary prevention (median follow-up of 3.9 years). Compared to normal low GGT plasma levels (below 28 U/L), total mortality but not risk for appropriate ICD therapy was elevated for higher GGT categories (p for trend = 0.004 in primary prevention and p for trend = 0.002 in secondary prevention, respectively). In Cox regression analysis, elevated GGT (>56 U/L) remained an independent predictor of death both in primary (p = 0.011) and in secondary prevention (p = 0.006). Patients with elevated GGT and renal insufficiency defined by an estimated glomerular filtration rate <60 ml/min/1.73 m(2) suffered from excess total mortality jeopardizing the benefit of ICD therapy. CONCLUSION: Elevation of GGT is an important adverse prognostic parameter in ICD patients. A possible role of GGT for improved patient selection for ICD therapy deserves further investigation.

Appropriate therapy but not inappropriate shocks predict survival in implantable cardioverter defibrillator patients.

BACKGROUND: Inappropriate implantable cardioverter defibrillator (ICD) shocks have been linked to a worse clinical outcome due to direct myocardial injury. HYPOTHESIS: The occurrence of ventricular tachyarrhythmia indicating progression of the underlying heart disease, but not the ICD shock itself, has prognostic impact in clinical routine. METHODS: In a retrospective study, 1117 recipients of an ICD were analyzed with respect to appropriate and inappropriate therapies and survival. RESULTS: During a mean follow-up of 2.92 years, appropriate therapy occurred in 27.7% and 54.0% of patients who had received an ICD for primary and secondary prevention of sudden cardiac death (SCD), respectively (P<0.0001). Inappropriate shock therapy occurred in 15.0% and 25.4% of patients who had received an ICD for primary and secondary prevention of SCD, respectively (P = 0.122). Appropriate ICD therapy had a strong impact on overall survival (P<0.0001), and this association was found both in primary (P<0.0001) and secondary (P = 0.002) prevention of SCD. Inappropriate ICD shocks had no impact on total mortality, neither in primary nor secondary prevention of SCD. CONCLUSIONS: Inappropriate shocks do not affect survival, in strong contrast to appropriate ICD therapy. Our study does not support the hypothesis that shock therapy in itself worsens clinical outcome. However, it confirms that appropriate ICD therapy is a warning sign and should prompt physicians to consider additional treatment strategies.

Long-term results of high vs. normal impedance ventricular leads on actual (Real-Life) pacemaker generator longevity.

AIM: The long-term effects of high impedance vs. standard impedance pacing leads on actual generator longevity were studied. METHODS AND RESULTS: In 40 patients (21 females, age 73 +/- 13 years) with standard dual-chamber pacemaker indication, bipolar standard impedance ventricular leads and high-impedance leads were implanted in a randomized fashion. Identical pacemaker generators and atrial pacing leads were implanted in all patients. Patients were observed during a mean follow-up of 89.8 +/- 8.8 months before pacemaker replacement. Initially, the patients who received the high-impedance leads had a lower current drain as compared with standard pacing impedance leads, and the estimated pacemaker longevity was significantly prolonged, too. But this pattern disappeared after 6 years of follow-up, and finally the actual pacemaker generators' replacement time was 86.7 +/- 6.8 months in standard impedance lead group vs. 91.2 +/- 10.3 months in high-impedance lead group (P = 0.17). CONCLUSION: Implantation of high pacing impedance leads for ventricular stimulation does not result in a benefit with respect to pacemaker longevity as compared with standard impedance leads.

Fusion of multislice computed tomography and electroanatomical mapping data for 3D navigation of left and right atrial catheter ablation.

PURPOSE: To assess whether fusion of multislice computed tomography (CT) images with electroanatomical (EA)-mapping data using a new image integration module (CartoMerge) is feasible and accurate to navigate ablation catheters in right and left atrial catheter ablation. MATERIAL AND METHODS: Twenty-four patients were examined with ECG-gated cardiac multislice CT (64 mm x 0.6mm, 0.33 s) 1 day before left atrial (LA) (15 patients) radiofrequency or right atrial cavotricuspid isthmus ablation (9 patients). CT data were fused with the non-fluoroscopic EA-mapping data by using dedicated software (CartoMerge) and the value of CT was analysed. RESULTS: In 23/24 (96%) patients, CT images could be fused with the EA-map. The alignment error was 2.16+/-0.35 mm. In 15/15 (100%) patients, CT added relevant anatomical information regarding the course of the esophagus or the pulmonary veins before LA-ablation. CT added useful information in only 3/8 (37.5%) of patients undergoing right atrial cavotricuspid isthmus ablation. CONCLUSION: 3D-navigation of RF-ablation catheters in the atria assisted by image fusion of multislice CT with EA-mapping data is feasible and accurate. CT added relevant anatomical information about the left atrium and the pulmonary veins before LA-ablation, CT also provided information about the course of the esophagus which might help to avoid thermal injury. CT image fusion might be of minor value before right atrial cavotricuspid isthmus catheter ablation.