Performance and acute procedural outcomes of the EnSite Precision™ cardiac mapping system for electrophysiology mapping and ablation procedures: results from the EnSite Precision™ observational study.

BACKGROUND: The EnSite Precision™ cardiac mapping system (Abbott) is a catheter navigation and mapping system capable of displaying the three-dimensional (3D) position of conventional and sensor-enabled electrophysiology catheters, as well as displaying cardiac electrical activity as waveform traces and dynamic 3D maps of cardiac chambers. The EnSite Precision™ Observational Study (NCT-03260244) was designed to quantify and characterize the use of the EnSite Precision™ cardiac mapping system for mapping and ablation of cardiac arrhythmias in a real-world environment and evaluate procedural outcomes. METHODS: A total of 1065 patients were enrolled at 38 centers in the USA and Canada between 2017 and 2018 and were followed for 12 months post procedure for arrhythmia recurrence, medication use, and quality-of-life changes. Eligible subjects were adults undergoing a cardiac electrophysiology mapping and radiofrequency ablation procedure using the EnSite Precision™ System. RESULTS: A final cohort of 925 patients (64.3 years of age, 30.2% female) were analyzed. The primary procedural indication was atrial flutter in 48.1% (445/925), atrial fibrillation in 46.5% (430/925), and other arrhythmias in 5% (50/925). Electroanatomic mapping was performed in 81.5% (754/925) of patients. Mapping was stable throughout 79.8% (738/925) of procedures with initial mapping time of 8.6 min (IQR 4.7-15.0). Average mapping efficiency created with AutoMap or TurboMap was 164.9 ± 365.7 used points per minute. Median number of mapping points collected and used was 1752.5 and 811.0, respectively. Only 335/925 (36.2%) required editing and 66.0% (221/335) of these patients required editing of less than 10 points. Fluoroscopy was utilized in most cases (n = 811/925, 87.4%) with fluoroscopy time of 11.0 min (IQR 6.0-18.0). Overall median procedure time was 101.0 min (IQR 59.0-152.0). Acute procedural success was high for both atrial fibrillation (n = 422/430, 98.1%) and atrial flutter (n = 434/445, 97.5%). CONCLUSION: In a real-world study analysis, use of the EnSite Precision™ mapping system was associated with high procedural stability, short mapping times, high point density requiring infrequent editing, low fluoroscopy time, and high prevalence of acute procedural success.

Multiple pudendal sensory pathways reflexly modulate bladder and urethral activity in patients with spinal cord injury.

PURPOSE: Electrical stimulation of pudendal afferents can evoke reflex bladder contractions with relaxation of the external urethral sphincter in cats. This voiding reflex is mediated by pudendal sensory fibers innervating the penile and prostatic urethra that engage spinal and spinobulbospinal micturition pathways, respectively. However, clinical translation of this potential therapy in individuals with spinal cord injury is limited by the lack of evidence showing analogous reflex mechanisms in humans. We investigated excitatory pudendal-to-bladder reflexes in 7 individuals with chronic spinal cord injury. MATERIALS AND METHODS: We recorded isovolumetric bladder pressure and perineal electromyogram in response to intraurethral electrical stimulation at varying amplitudes and frequencies. RESULTS: Selective electrical stimulation of the proximal (29.7 ± 11.6 cm H(2)O) and distal urethral (23.3 ± 9.28 cm H(2)O) segments evoked sustained reflex bladder contractions in different subsets (3 each) of participants. In contrast, the corresponding reflex perineal electromyogram revealed a differential activation pattern between proximal and distal intraurethral stimulation (normalized electromyogram of 1.3 ± 0.2 and 0.3 ± 0.1, respectively, p <0.05). CONCLUSIONS: To our knowledge we report the first clinical evidence of 2 independent excitatory pudendal-to-bladder reflex pathways, which in turn differentially modulate efferent pudendal output. Each reflex mechanism involves complex interaction of multiple sensory inputs and may provide a neural substrate to restore micturition after spinal cord injury.

Conditional and continuous electrical stimulation increase cystometric capacity in persons with spinal cord injury.

AIMS: Individuals with spinal cord injury (SCI) exhibit neurogenic detrusor overactivity (NDO) causing high intravesicle pressures and incontinence. The first aim was to measure changes in maximum cystometric capacity (MCC) evoked by electrical stimulation of the dorsal genital nerve (DGN) delivered either continuously or conditionally (only during bladder contractions) in persons with SCI. The second aim was to use the external anal sphincter electromyogram (EMG(EAS)) for real-time control of conditional stimulation. METHODS: Serial filling cystometries were performed in nine volunteers with complete or incomplete supra-sacral SCI. Conditional stimulation was delivered automatically when detrusor pressure increased to 8-12 cmH(2)O above baseline. MCCs were measured for each treatment (continuous, conditional, and no stimulation) and compared using post-ANOVA Tukey HSD paired comparisons. Additional treatments in two subjects used the EMG(EAS) for automatic control of conditional stimulation. RESULTS: Continuous and conditional stimulation increased MCC by 63 +/- 73 ml (36 +/- 24%) and 74 +/- 71 ml (51 +/- 37%), respectively (P < 0.05), compared to no stimulation. There was no significant difference between MCCs for conditional and continuous stimulation, but conditional stimulation significantly reduced stimulation time (174 +/- 154 sec, or 27 +/- 17% of total time) as compared to continuous stimulation (469 +/- 269 sec, 100% of total time, P < 0.001). The EMG(EAS) algorithm provided reliable detection of bladder contractions (six of six contractions over four trials) and reduced stimulation time (21 +/- 8% of total time). CONCLUSIONS: Conditional stimulation generates increases in bladder capacity while substantially reducing stimulation time. Furthermore, EMG(EAS) was successfully used as a real-time feedback signal to control conditional electrical stimulation in a laboratory setting.

Intraurethral activation of excitatory bladder reflexes in persons with spinal cord injury.

Electrical activation of an excitatory reflex between sensory fibers in the pudendal nerve and the bladder has been demonstrated in cats and is a potential means of restoring micturition function in persons with spinal cord injury. We investigated the clinical feasibility of activating this reflex to restore bladder function in persons with spinal cord injury by using intraurethral electrical stimulation to activate pudendal sensory fibers innervating the urethra. Excitatory bladder responses (contractions) were evoked by trains of electrical pulses applied to either the proximal (29.7 +/- 11.6 cmH2O) or distal (30.2 +/- 11.6 cmH2O) segment of the urethra. The results indicate that an excitatory reflex between pudendal nerve afferents and the bladder exists in humans with spinal injury and may provide a substrate for restoring micturition function.

Pudendal nerve stimulation evokes reflex bladder contractions in persons with chronic spinal cord injury.

AIMS: Although electrical stimulation of the pudendal nerve has been shown to evoke reflex micturition-like bladder contractions in both intact and spinalized cats, there is little evidence to suggest that an analogous excitatory reflex exists in humans, particularly those with spinal cord injury (SCI). We present two cases where electrical activation of pudendal nerve afferents was used to evoke excitatory bladder responses. SUBJECTS AND METHODS: A percutaneously placed catheter electrode was used to electrically stimulate the pudendal nerve trunk in two males with SCI. The response was quantified with recorded changes in detrusor pressure and EMG activity of the external anal sphincter. RESULTS: In both individuals, frequency specific (f = 20-50 Hz) activation of the pudendal nerve trunk evoked excitatory bladder contractions that also depended on the stimulus amplitude and bladder volume. CONCLUSION: The results suggest that selective activation of the perineal branches of the pudendal nerve may further augment the excitatory reflex evoked by electrical stimulation.