Electrocardiogram Belt guidance for left ventricular lead placement and biventricular pacing optimization.

BACKGROUND: Patients with ischemic cardiomyopathy, non-left bundle branch block, or QRS duration <150 ms have a lower response rate to cardiac resynchronization therapy (CRT) than did other indicated patients. The ECG Belt system (EBS) is a novel surface mapping system designed to measure electrical dyssynchrony via the standard deviation of the activation times of the left ventricle. OBJECTIVES: The objectives of this study were to evaluate the efficacy of the EBS in patients less likely to respond to CRT and to determine whether EBS use in lead placement guidance and device programming was superior to standard CRT care. METHODS: This was a prospective randomized trial of patients with heart failure and EBS-guided CRT implantation and programming vs standard CRT care. The primary end point was relative change in left ventricular end-systolic volume from baseline to 6 months postimplantation. RESULTS: A total of 408 patients from centers in Europe and North America were randomized. Although both patients with EBS and control patients had a mean improvement in left ventricular end-systolic volume, there was no significant difference in relative change from baseline (P = .26). While patients with a higher baseline standard deviation of the activation times derived greater left ventricular reverse remodeling, improvement in electrical dyssynchrony did not correlate with the extent of reverse remodeling. CONCLUSION: The findings of the present study do not support EBS-guided therapy for CRT management of heart failure with reduced ejection fraction.

Efficacy and Safety of an Extravascular Implantable Cardioverter-Defibrillator.

BACKGROUND: The extravascular implantable cardioverter-defibrillator (ICD) has a single lead implanted substernally to enable pause-prevention pacing, antitachycardia pacing, and defibrillation energy similar to that of transvenous ICDs. The safety and efficacy of extravascular ICDs are not yet known. METHODS: We conducted a prospective, single-group, nonrandomized, premarket global clinical study involving patients with a class I or IIa indication for an ICD, all of whom received an extravascular ICD system. The primary efficacy end point was successful defibrillation at implantation. The efficacy objective would be met if the lower boundary of the one-sided 97.5% confidence interval for the percentage of patients with successful defibrillation was greater than 88%. The primary safety end point was freedom from major system- or procedure-related complications at 6 months. The safety objective would be met if the lower boundary of the one-sided 97.5% confidence interval for the percentage of patients free from such complications was greater than 79%. RESULTS: A total of 356 patients were enrolled, 316 of whom had an implantation attempt. Among the 302 patients in whom ventricular arrhythmia could be induced and who completed the defibrillation testing protocol, the percentage of patients with successful defibrillation was 98.7% (lower boundary of the one-sided 97.5% confidence interval [CI], 96.6%; P<0.001 for the comparison with the performance goal of 88%); 299 of 316 patients (94.6%) were discharged with a working ICD system. The Kaplan-Meier estimate of the percentage of patients free from major system- or procedure-related complications at 6 months was 92.6% (lower boundary of the one-sided 97.5% CI, 89.0%; P<0.001 for the comparison with the performance goal of 79%). No major intraprocedural complications were reported. At 6 months, 25 major complications were observed, in 23 of 316 patients (7.3%). The success rate of antitachycardia pacing, as assessed with generalized estimating equations, was 50.8% (95% CI, 23.3 to 77.8). A total of 29 patients received 118 inappropriate shocks for 81 arrhythmic episodes. Eight systems were explanted without extravascular ICD replacement over the 10.6-month mean follow-up period. CONCLUSIONS: In this prospective global study, we found that extravascular ICDs were implanted safely and were able to detect and terminate induced ventricular arrhythmias at the time of implantation. (Funded by Medtronic; ClinicalTrials.gov number, NCT04060680.).

Inapparent atrial flutter due to atrial dissociation.

Percutaneous and surgical procedures intended to potentially cure atrial fibrillation require creating lines of conduction block in specific locations throughout the atrial chambers. In patients presenting with recurrent atrial fibrillation, repeat procedures are often performed, resulting in more extensive regions of conduction block and the potential for regions of dissociated atrial rhythms. The present case describes a patient post-multiple ablation procedures who presented with a symptomatic atrial arrhythmia, the mechanism of which was hidden by the presence of extensive atrial dissociation. Electrophysiologic study revealed the appropriate mechanism and a beneficial ablative procedure was then successfully accomplished.

Traversing and dilating venous collaterals: a useful adjunct in left ventricular electrode placement.

In patients receiving cardiac resynchronization therapy (CRT), the left ventricular electrode cannot always be positioned in the preferred lateral or posterolateral locations due to technical factors and anatomic variations in the coronary sinus. Recent reports also suggest that CRT outcomes are improved by pacing the site of latest dyssynchrony and accessing these regions is not always possible. We report the utility of applying a technique described in the interventional literature over the past 3 years, effectively traversing and dilating collateral channels. Our patients demonstrated either no venous targets in the optimal location, or problems accessing this location using a antegrade approach. Subsequently, collaterals supplying this region were traversed with a guidewire using a retrograde approach and dilated with a balloon catheter. In the first case, the pacing electrode was then advanced in similar fashion and successfully positioned in an ideal lateral location. In the second case, the retrograde guidewire was captured with a vascular snare and pulled into a second guiding catheter, allowing appropriate dilatation and stenting of a problematic proximal venous stenosis with resultant facile placement of the pacing electrode. This technique offers a potential alternative to patients with challenging venous anatomy as a method to facilitate optimal CRT outcomes.