Device-related outcomes following hypoglossal nerve stimulator implantation.

STUDY OBJECTIVES: Hypoglossal nerve stimulation (HGNS) has been widely used to treat obstructive sleep apnea in selected patients. Here we evaluate rates of revision and explant related to HGNS implantation and assess types of adverse events contributing to revision and explant. METHODS: Postmarket surveillance data for HGNS implanted between January 1, 2018 and March 31, 2022, were collected. Event rates and risk were calculated using the postmarket surveillance event counts and sales volume over the same period. Indications were categorized for analysis. Descriptive statistics were reported and freedom from explant or revision curves were grouped by year of implantation. RESULTS: Of the 20,881 HGNS implants assessed, rates of explant and revision within the first year were 0.723% and 1.542%, respectively. The most common indication for explant was infection (0.378%) and for revision was surgical correction (0.680%). Of the 5,820 devices with 3-year postimplantation data, the rate of explant was 2.680% and of revision was 3.557%. During this same interval, elective removal (1.478%) was the most common indication, and for revisions, surgical correction (1.134%). CONCLUSIONS: The efficacy of HGNS is comparable in the real world setting to published clinical trial data. Rates of explant and revision are low, supporting a satisfactory safety profile for this technology. CITATION: Moroco AE, Wei Z, Byrd I, et al. Device-related outcomes following hypoglossal nerve stimulator implantation. J Clin Sleep Med. 2024;20(9):1497-1503.

Absence of (sub-)acute cerebral events or lesions after electroporation ablation in the left-sided canine heart.

BACKGROUND: Irreversible electroporation (IRE) is a nonthermal ablation modality. A 200-J application can create deep myocardial lesions, but gas bubbles are created at the ablation electrode. Cerebral effects of these bubbles are unknown. OBJECTIVE: The purpose of this study was to investigate gas microemboli-induced brain lesions after IRE and radiofrequency (RF) ablation to the left side of the canine heart, using magnetic resonance imaging (MRI) and histopathology. METHODS: In 11 canines, baseline cerebral MRI scans were performed. In 9 animals, after retrograde femoral artery access, 12 ± 4 200-J IRE applications were administered in the ascending aorta. In 2 animals, 30 minutes of irrigated 30-W RF ablation using 10-30g of contact force was applied in the left ventricle. At days 1 and 5 after ablation, MRI was repeated. The brain tissue then was histopathologically examined. RESULTS: All ablations and follow-up were uneventful. Intracardiac echography confirmed gas bubble formation after each IRE application. Neurologic examination was normal. MRI scans were normal in all animals at day 1 and were normal in 10 of 11 animals at day 5. In 1 animal, a single <2-mm-diameter lesion in the right temporal region could not be excluded as a small infarct or early hemorrhagic site. Histopathologic analysis of the same region showed no pathologic changes. In all other animals, gross and microscopic pathology were normal. CONCLUSION: MRI images alone or in combination with histologic follow-up did not reveal treatment-related embolic events. Gross and microscopic pathology did not reveal evidence of treatment-related embolic events. IRE seems to be a safe ablation modality for the brain.

Voltage-based device tracking in a 1.5 Tesla MRI during imaging: initial validation in swine models.

PURPOSE: Voltage-based device-tracking (VDT) systems are commonly used for tracking invasive devices in electrophysiological cardiac-arrhythmia therapy. During electrophysiological procedures, electro-anatomic mapping workstations provide guidance by integrating VDT location and intracardiac electrocardiogram information with X-ray, computerized tomography, ultrasound, and MR images. MR assists navigation, mapping, and radiofrequency ablation. Multimodality interventions require multiple patient transfers between an MRI and the X-ray/ultrasound electrophysiological suite, increasing the likelihood of patient-motion and image misregistration. An MRI-compatible VDT system may increase efficiency, as there is currently no single method to track devices both inside and outside the MRI scanner. METHODS: An MRI-compatible VDT system was constructed by modifying a commercial system. Hardware was added to reduce MRI gradient-ramp and radiofrequency unblanking pulse interference. VDT patches and cables were modified to reduce heating. Five swine cardiac VDT electro-anatomic mapping interventions were performed, navigating inside and thereafter outside the MRI. RESULTS: Three-catheter VDT interventions were performed at >12 frames per second both inside and outside the MRI scanner with <3 mm error. Catheters were followed on VDT- and MRI-derived maps. Simultaneous VDT and imaging was possible in repetition time >32 ms sequences with <0.5 mm errors, and <5% MRI signal-to-noise ratio (SNR) loss. At shorter repetition times, only intracardiac electrocardiogram was reliable. Radiofrequency heating was <1.5°C. CONCLUSION: An MRI-compatible VDT system is feasible.

Contact geometry affects lesion formation in radio-frequency cardiac catheter ablation.

One factor which may be important for determining proper lesion creation during atrial ablation is catheter-endocardial contact. Little information is available that relates geometric contact, depth and angle, to ablation lesion formation. We present an electrothermal computer model of ablation that calculated lesion volume and temperature development over time. The Pennes bioheat equation was coupled to a quasistatic electrical problem to investigate the effect of catheter penetration depth, as well as incident catheter angle as may occur in practice. Biological experiments were performed to verify the modelling of electrical phenomena. Results show that for deeply penetrating tips, acute catheter angles reduced the rate of temperature buildup, allowing larger lesions to form before temperatures elevated excessively. It was also found that greater penetration did not lead to greater transmurality of lesions. We conclude that catheter contact angle plays a significant role in lesion formation, and the time course must be considered. This is clinically relevant because proper identification and prediction of geometric contact variables could improve ablation efficacy.

Contact sensing provides a highly accurate means to titrate radiofrequency ablation lesion depth.

BACKGROUND: Transmural lesions are essential for efficacious ablation. There are, however, no accurate means to estimate lesion depth. OBJECTIVE: Explore use of the electrical coupling index (ECI) from the EnSite Contact™ System as a potential variable for lesion depth estimation. METHODS: Radiofrequency (RF) ablation lesions were created in atria and the thighs of swine using an irrigated RF catheter. Power was 30 W for 20 or 30 seconds intracardiac and 30-50 W for 10-60 seconds for the thigh. Intracardiac, the percentage change in ECI during ablation was compared with transmurality and collateral damage occurrence. For the thigh model, an algorithm estimating lesion depth was derived. Factors included: power, duration, and change in the ECI subcomponents (ΔECI+) during ablation. The ΔECI+ algorithm was compared to one using power and duration (PD) alone. RESULTS: Intracardiac, lesions with ≥12% reduction in ECI were more likely to be transmural (92.3% vs. 59.4%, P < 0.001). Twenty-second lesions were less likely to cause collateral damage compared to 30 seconds (33% vs. 70%, P = 0.003), while transmurality was similar. With the thigh model, ΔECI+ had a better correlation than the PD algorithm (P < 0.01). Accuracy of the ΔECI+ algorithm was unimproved with inclusion of tip orientation, while PD improved (R(2) = 0.64). DISCUSSION: Change in ECI provides evidence of transmural versus nontransmural swine intracardiac atrial lesions. A lesion depth estimation algorithm using ECI subcomponents is unaffected by tip orientation and is more accurate than using PD alone. CONCLUSION: Use of ECI as a factor in a lesion depth algorithm may provide clinically valuable information regarding the efficacy of intracardiac RF ablation lesions.

Cathether contact geometry affects lesion formation in radio-frequency cardiac catheter ablation.

One factor which may be important for determining proper lesion creation in an atrial ablation procedure is catheter-endocardial contact. Little information is available that relates geometric contact, depth and angle, to ablation lesion formation. We present an electrothermal computer model of ablation that calculates lesion volume and temperature development over time. The Pennes bioheat equation was coupled to a quasistatic electrical problem. This method simulates importantly, not just catheter penetration depth, but also several different incident catheter angles as may occur in practise. Results show that for deeply penetrating tips, greater catheter angles reduce the rate of temperature buildup, allowing for larger lesions to form before temperatures become dangerous. It was also found that greater penetration may not lead to greater transmurality in lesion formation. We conclude that catheter contact angle plays a significant role in lesion formation, and the time course must be considered. This is clinically relevant because it makes proper identification and prediction of geometric contact variables a necessity in order to improve ablation efficacy and safety.

Phase angle shift is a better determinant for catheter electrode contact with tissue compared to a catheter sensed electrogram.

Convention holds that the magnitude of an electrogram (EGM) recorded from an ablation catheter indicates proximity to the tissue and may be used to guide tip placement. The shift in capacitance (phase angle) as the electrode touches the tissue may be a better guide. We compared these two methods over a range of distances in close proximity to heart tissue. This study suggests that EGM is not a reliable predictor of proximity to tissue within a few millimeters of the surface. Thus, EGM alone should not be used to guide electrode placement for ablation, as a millimeter off the surface will shift a greater percentage of delivered energy to the blood pool rather than the target tissue. EGM should also not be used to gauge force of the catheter into tissue. Phase angle is a better predictor of both variables, but an optimal combination of predictors remains to be found.

Interactions between paced wavefronts and monomorphic ventricular tachycardia: implications for antitachycardia pacing.

OBJECTIVES: Interactions between paced wavefronts and monomorphic ventricular tachycardia (VT) dictate antitachycardia pacing outcomes. We used optical mapping to assess those interactions during single and dual site pacing of rabbit ventricular epicardium. METHODS AND RESULTS: Monomorphic VTs were initiated in six isolated rabbit hearts that were endocardially cryoablated to limit viable tissue to visible epicardium and establish apical tissue as the anatomic anchor. Preparations were optically mapped during single (n = 39) and dual (n = 43) site pacing at 50%-90% of VT cycle length (CL) with eight pulses per trial. Overall, we found six pulses that abruptly terminated VT. This occurred because the VT wavefront collided with the antidromic portion of the paced wavefront and the orthodromic portion of paced wavefront blocked in the VT's refractory region. When effective, dual site pacing that captured tissue at both leads simultaneously terminated the VT immediately, while single site pacing or dual site pacing that captured tissue at only one lead terminated the VT after resetting advanced the orthodromic wavefront. We found 12 pulses that induced polymorphic VT, with 11 of those pulses occurring during capture at only one lead. Expansion of the combined antidromic-VT wavefront around one or both ends of the arc of conduction block formed by the interaction of the orthodromic wavefront with the VT's refractory region initiated functional reentry. Six of these polymorphic VTs were nonsustained because the underlying wavefronts self-terminated. The wavefronts did persist for 4.2 +/- 3.5 cycles before self-terminating in these trials, and the post-pacing cycles presented a 146% increase in CL variability, compared with the variability prior to pacing. These temporal characteristics are similar to those of delayed termination in patients with ICDs. CONCLUSIONS: The main difference between pulses that terminated abruptly and pulses that induced polymorphic VT was the effective separation of the antidromic and orthodromic portions of the paced wavefront from one another.

Delayed termination following pacing induced shifts from monomorphic to polymorphic ventricular tachycardia: implications for antitachycardia pacing.

Interactions between paced wavefronts and monomorphic ventricular tachycardia (VT) dictate antitachycardia pacing outcomes. Monomorphic VTs were initiated in isolated rabbit hearts (n=6) that were endocardially cryoablated to limit viable tissue to the visible epicardium and the ablated apex served as an anatomic anchor. Preparations were optically mapped during single and dual site pacing at 50% to 90% of VT cycle length with 8 pulses per trial. Of these trials, responses to the 48 single site pulses and to the 172 dual site pulses that captured tissue were analyzed. Overall, we found most pulses reset the VT, and a small number of pulses that abruptly terminated the VT. Of particular interest, we found 12 pulses that shifted the anatomically anchored VT to functionally reentrant wavefronts, and thereby induced polymorphic VT. Delayed termination was observed following 6 of these instances, and the underlying non-sustained polymorphic VT's presented temporal characteristics similar to those presented by delayed termination after antitachycardia pacing in ICD patients.

Comparison of conventional and biventricular antitachycardia pacing in a geometrically realistic model of the rabbit ventricle.

INTRODUCTION: ICDs often are programmed with antitachycardia pacing (ATP) as the first response to ventricular tachycardia (VT). Many ICDs have an additional lead available for ventricular pacing. We hypothesized that using the additional lead for ATP would improve therapy by advancing the orthodromic wavefront, thereby reducing the size of the excitable gap and inducing block of all reentrant activity. METHODS AND RESULTS: Monomorphic VT was initiated in a thin-walled model of rabbit ventricular myocardium that included an apical infarct and anatomically realistic dimensions. ATP with up to eight pulses was delivered at 90% of VT cycle length to one (conventional) or two (biventricular) stimulation areas. Stimulation areas were adjusted from 0.017 cm2 to 0.169 cm2 to modulate interactions between the antidromic and VT wavefronts, and between the orthodromic wavefront and the VT's refractory region. During conventional ATP, we found that larger stimulation areas terminated the VT in three pulses. Continued pacing after termination caused VT reinitiation in the reversed direction in some instances. With smaller stimulation areas, conventional ATP simply reset the circuit. During biventricular ATP, larger stimulation areas terminated VT in one pulse. There were no instances of reinitiation with reversal. However, with smaller stimulation areas, prolongation of refractoriness near the additional stimulation area facilitated induction of functional reentry with pathways modified by continued pacing. CONCLUSION: Our modeling suggests that biventricular ATP is superior to conventional ATP under conditions where the additional ventricular lead effectively advances the orthodromic wavefront. Failure to achieve this advancement poses a risk of VT acceleration.