Characterization of Lesions Created by a Heated, Saline Irrigated Needle-Tip Catheter in the Normal and Infarcted Canine Heart.

BACKGROUND: Inability to eliminate intramural arrhythmogenic substrate may lead to recurrent ventricular tachycardia after catheter ablation. The aim of the present study was to evaluate intramural and full thickness lesion formation using a heated saline-enhanced radiofrequency (SERF) needle-tip catheter, compared with a conventional ablation catheter in normal and infarcted myocardium. METHODS: Twenty-two adult mongrel dogs (30-40 kg, 15 normal and 7 myocardial infarct group) were studied. Lesions were created using the SERF catheter (40 W/50 °C) or a standard contact force (CF) catheter in both groups. RESULTS: Comparing SERF to CF ablation, the SERF catheter produced larger lesion volumes than the standard CF catheter-even with >20 g of CF-in both normal (983.1±905.8 versus 461.9±178.3 mm3; P=0.023) and infarcted left ventricular myocardium (1052.3±543.0 versus 340.3±160.5 mm3; P=0.001). SERF catheter lesions were more often transmural than standard CF lesions with >20 g of CF in both groups (59.1% versus 7.7%; P<0.001 and 60.0% versus 12.5%; P=0.017, respectively). Using the SERF catheter, mean depth of ablated lesions reached 90% of the left ventricular wall in both normal and infarcted myocardium. CONCLUSIONS: The SERF catheter created more transmural and larger ablative lesions in both normal and infarcted canine myocardium. SERF ablation is a promising new approach for endocardial intramural and full thickness ablation of ventricular tachycardia substrate that is not accessible with current techniques.

Novel Techniques in Epilepsy Management: Venous Pacing and Capture of Electrical Activity in the Primate Cortex.

OBJECTIVE: Pharmacotherapy for epilepsy is limited with 30% of patients refractory to this approach of suppressing seizures. Current surgical options are invasive and carry significant morbidities including infection, bleeding, and the potential for deleterious neurocognitive effects. As a result, there is a burgeoning need for innovation to develop safer and efficacious interventions. METHODS: Four distinct catheters (2 existing: Cardima catheter, Standard EPT Blazer catheter; 2 new prototypes: balloon catheter, basket catheters) were tested in 12 baboons (21-30 kg, 100% male). For each, we assessed whether or not the catheter was able to be maneuvered safely in various locations of the cerebral venous system, provide adequate cortical tissue contact to record signals, detect these signals as normal or abnormal, successfully stimulate the cortex, and capture the cortical tissue. Locations trialed included the petrosal sinus, straight sinus, vein of Galen, and occipital vein. Pacing cycle length and pacing thresholds varied among experiments. RESULTS: Successful mapping was conducted in all 12 baboons. The pacing cycle length varied from 75 ms to 650 ms depending on location of the cortex. Pacing threshold was recorded in 4/12 (33%) of the experiments; data is not available for the remaining 8/12 experiments. The threshold values ranged from 0.3 - 20 mAmps. Capture of cortical electrical activity was observed in 11/12 (91.7 %) experiments though the number of successful capture and stimulation attempts varied among experiments. The most reliable and consistent capture occurred with the use of our novel prototyped over-the-wire balloon catheter (9/12; 75%) and basket catheter (3/3; 100%). Necropsy and histology were performed post-experimentation, and only minimal complications were noted (Table 1). CONCLUSION: New electrode design can be maneuvered safely in the venous system, provide adequate cortical tissue contact to record signals, detect these signals as normal or abnormal, successfully stimulate the cortex, and capture cortical tissue. These novel devices merit further study in chronic baboons to establish long-term efficacy of continuous seizure recording.

Prevention of Coagulum Formation With Simultaneous Charge Delivery in Radiofrequency Ablation: A Canine Model.

OBJECTIVES: This study reports on a novel method to prevent coagulum formation by continuously delivering a negative charge to the catheter tip to repel negatively charged fibrinogen molecules during RF ablation. BACKGROUND: Radiofrequency (RF) ablation for cardiac arrhythmias is associated with a 70% incidence of coagulum formation on the catheter tip during ablation and a 10% incidence of thromboembolic events. Catheter tip thrombus can impede RF energy to the tissue, reducing efficacy and increasing procedure times. METHODS: A novel circuit was built to deliver a negative, fixed-offset, direct current-based charge using a 9-V battery, placed in parallel with an RF delivery unit during RF ablation. In in vivo canine experiments, standard ablation catheters were advanced into atria and ventricles under fluoroscopic guidance. The presence of thrombus with and without RF delivery was identified with intracardiac echocardiography. RESULTS: Scanning electron microscopy of the catheter tips showed clot coverage of the catheter tip to be 90% for noncharged catheters compared to 0% (p < 0.01) in negatively charged catheters. Volume of clot formed on the catheter tip decreased with increased amount of charge (140 ± 5.3 arbitrary units with no charge vs. 0 arbitrary units with a 100-µA current delivering negative charge, p < 0.01). Application of a negative charge did not affect the quality of the intracardiac electrogram or induce malignant ventricular arrhythmias. CONCLUSIONS: Negative-charge delivery to ablation catheter tips and tissue during RF ablation is feasible and safe and can eliminate coagulum formation, potentially reducing thromboembolic complications.

Advances in radiofrequency ablation of the cerebral cortex in primates using the venous system: Improvements for treating epilepsy with catheter ablation technology.

BACKGROUND: Pharmacology frequently fails for the treatment of epilepsy. Although surgical techniques are effective, these procedures are highly invasive. We describe feasibility and efficacy of minimally invasive mapping and ablation for the treatment of epilepsy. METHODS: Mapping and radiofrequency ablations were performed via the venous system in eleven baboons and three dogs. RESULTS: Mapping in deep cerebral areas was obtained in all animals. High-frequency pacing was able to induce seizure activity of local cerebral tissue in 72% of our attempts. Cerebral activity could be seen during mapping. Ablative lesions were deployed at deep brain sites without steam pops or sudden impedance rise. Histologic analysis showed necrosis at the sites of ablation in all primates. CONCLUSION: Navigation through the cerebral venous system to map seizure activity is feasible. Radiofrequency energy can be delivered transvenously or transcortically to successfully ablate cortical tissue in this animal model using this innovative approach.

Luminal esophageal temperature monitoring with a deflectable esophageal temperature probe and intracardiac echocardiography may reduce esophageal injury during atrial fibrillation ablation procedures: results of a pilot study.

BACKGROUND: Luminal esophageal temperature (LET) monitoring is one strategy to minimize esophageal injury during atrial fibrillation ablation procedures. However, esophageal ulceration and fistulas have been reported despite adequate LET monitoring. The objective of this study was to assess a novel approach to LET monitoring with a deflectable LET probe on the rate of esophageal injury in patients undergoing atrial fibrillation ablation. METHODS AND RESULTS: Forty-five consecutive patients undergoing an atrial fibrillation ablation procedure followed by esophageal endoscopy were included in this prospective observational pilot study. LET monitoring was performed with a 7F deflectable ablation catheter that was positioned as close as possible to the site of left atrial ablation using the deflectable component of the catheter guided by visualization of its position on intracardiac echocardiography. Ablation in the posterior left atrial was limited to 25 W and terminated when the LET increased 2°C from baseline. Endoscopy was performed 1 to 2 days after the procedure. All patients had at least 1 LET elevation >2°C necessitating cessation of ablation. Deflection of the LET probe was needed to accurately measure LET in 5% of patients when ablating near the left pulmonary veins, whereas deflection of the LET probe was necessary in 88% of patients when ablating near the right pulmonary veins. The average maximum increase in LET was 2.5±1.5°C. No patients had esophageal thermal injury on follow-up endoscopy. CONCLUSIONS: A strategy of optimal LET probe placement using a deflectable LET probe and intracardiac echocardiography guidance, combined with cessation of radiofrequency ablation with a 2°C rise in LET, may reduce esophageal thermal injury during left atrial ablation procedures.

Synchronous ventricular pacing without crossing the tricuspid valve or entering the coronary sinus--preliminary results.

BACKGROUND: Right ventricular apical (RVA) pacing promotes tricuspid regurgitation (TR), electromechanical dyssynchrony, and ventricular dysfunction. We tested a novel intramyocardial bipolar lead to assess whether stimulation of the atrioventricular septum (AVS) produces synchronous ventricular activation without crossing the tricuspid valve (TV). METHODS: A lead with an active external helix and central pin was placed on the AVS and the RVA in three dogs. High-density electroanatomic (EA) mapping was performed of both ventricles endocardially and epicardially. Intracardiac echocardiography was used to access ventricular synchrony. RESULTS: The lead was successfully deployed into the AVS in all cases with consistent capture of the ventricular myocardium without atrial capture or sensing. The QRS duration was less with AVS compared with RVA pacing (89 +/- 4 ms vs. 100 +/- 11 ms [P < 0.0001, GEE P = 0.03]). There was decreased delay between color Doppler M-mode visualized peak contraction of the septum and the mid left ventricular free wall with AVS compared with RVA pacing (89 +/- 91 ms vs. 250 +/- 11 ms [P < 0.0001, GEE P = 0.006]). Activation time between the mid septum and mid free wall was shorter with AVS versus RVA pacing (20.4 +/- 7.7 vs. 30.8 +/- 11.6 [P = 0.01, GEE P = 0.07]). The interval between QRS onset to earliest free wall activation was shorter with AVS vs. RVA pacing (19.2 +/- 6.4 ms vs. 31.1 +/- 11.7 ms [P = 0.005, GEE P = 0.02]). CONCLUSION: The AVS was successfully paced in three dogs resulting in synchronous ventricular activation without crossing the TV.

Distortion of right superior pulmonary vein anatomy by balloon catheters as a contributor to phrenic nerve injury.

INTRODUCTION: Cryothermal, HIFU, and laser catheter-based balloon technologies have been developed to simplify ablation for AF. Initial enthusiasm for their widespread use has been dampened by phrenic nerve (PN) injury. The interaction between PN and pulmonary vein (PV) geometry contributing to PN injury is unclear. METHODS AND RESULTS: After right thoracotomy, the PN course along the epicardial right atrial surface was mapped directly in 10 dogs. The location of the PN and its relationship with the right superior (RS) PV, and potential RSPV surface distortions after balloon inflation were established by electroanatomic mapping. In 5 dogs, the PN was captured within the RSPV, but could not be stimulated in the remaining 5 dogs. The distance between the RSPV and the PN was significantly shorter in the captured group than in the noncaptured group (6.3 +/- 3.1 mm vs 10.2 +/- 3.2 mm, P < 0.001). Importantly, 96% of the captured sites within the RSPV were observed at a distance >5 mm into the PV. The inflated balloon surface anteriorly extended 5.6 +/- 3.7 mm outside the PV diameter, with distortion of anatomy narrowing the distance from the balloon surface to the PN to 4.8 +/- 2.3 mm. (Distance of the original RSPV-to-PN: 9.4 +/- 2.7 mm, P < 0.001.) CONCLUSION: PN injury with balloon technologies may stem from anatomic distortion of the PV orifice/PN relationship, through increasing contact or shortening the relative distance between the ablation site and the PN, even without displacement of the balloon into the PV. These data are important in the refinement of these technologies to improve procedural safety.

Catecholaminergic polymorphic ventricular tachycardia: a current overview.

Catecholaminergic polymorphic ventricular tachycardia occurs in healthy children and young adults causing syncope and sudden cardiac death. This is a familial disease, which affect de novo mutation in 50% of the cases. At least two causative genes have been described to be localized in the chromosome 1; mutation of the ryanodine receptor gene and calsequestrin gene. The classical clinical presentation is syncope triggered by exercise and emotion in children and adolescents with no structural heart disease. Polymorphic ventricular tachycardia during treadmill testing, or after isoproterenol infusion, is the most common feature. Therapeutic options include, beta-blockers, calcium-channel blockers and, an implantable cardioverter defibrillator is indicated in high-risk patients. Risk stratification of this disease is very challenging, since some risk factors proved to be useful in some series but not in others. However, family history of sudden cardiac death and symptoms initiated in very young children are important predictors.

Utilization of retrograde right bundle branch block to differentiate atrioventricular nodal from accessory pathway conduction.

INTRODUCTION: Defining whether retrograde ventriculoatrial (V-A) conduction is via the AV node (AVN) or an accessory pathway (AP) is important during ablation procedures for supraventricular tachycardia (SVT). With the introduction of ventricular extrastimuli (VEST), retrograde right bundle branch block (RBBB) may occur, prolonging the V-H interval, but only when AV node conduction is present. We hypothesized that when AP conduction was present, the V-A interval would increase less than the V-H interval, whereas with retrograde nodal conduction, the V-A interval would increase at least as much as the V-H interval. METHODS AND RESULTS: We retrospectively reviewed the electrophysiological studies of patients undergoing ablation for AVN reentrant tachycardia (AVNRT) (55) or AVRT (50), for induction of retrograde RBBB during the introduction of VEST, and the change in the measured V-H and V-A intervals. Results were found to be reproducible between independent observers. Out of 105 patients, 84 had evidence of induced retrograde RBBB. The average V-H interval increase with induction of RBBB was 53.7 ms for patients with AVRT and 54.4 ms for patients with AVNRT (P = NS). The average V-A interval increase with induction of RBBB was 13.6 ms with AVRT and 70.1 ms with AVNRT (P < 0.001). All patients with a greater V-H than V-A interval change had AVRT, and those with a smaller had AVNRT. CONCLUSIONS: Induction of retrograde RBBB during VEST is common during an electrophysiological study for SVT. The relative change in the intervals during induction of RBBB accurately differentiates between retrograde AVN and AP conduction.

New generation of electro-anatomic mapping: full intracardiac ultrasound image integration.

Surrogate electro-anatomic-derived geometries are used as the three-dimensional (3D) basis for mapping of cardiac arrhythmias. While merged computed tomography (CT) imaging may provide stellar pulmonary vein (PV) and left atrial (LA) anatomy, the applied scans must be obtained prior to ablation, and may not reflect physiologic conditions at the time of intervention. Patient-specific, ultrasound-derived 3D imaging has been developed as an alternative basis for new generation electro-anatomic mapping. An electro-anatomic sensor positioned at the tip of the phased-array intracardiac ultrasound catheter, provides the means to specify both location and orientation of each image as the 'context' for creating the 3D volumes for co-registration with electro-anatomic mapping. Specific anatomic details such as the pulmonary veins, membranous fossa, papillary muscles, or valve structures derived from real-time imaging can also be integrated into each segmented volume. This presentation reviews the basis and methods for this novel multi-modality image fusion for the creation of robust, nearly real-time anatomic images for guiding electro-anatomic mapping and ablation without requiring pre-acquired CT image sets, with accompanying limitations.

Successful radiofrequency ablation of the cerebral cortex in pigs using the venous system: possible implications for treating CNS disorders.

BACKGROUND: When pharmacotherapy for epilepsy fails, surgical options, although efficacious, are highly invasive. We explored whether ablation of the cerebral cortex can be performed utilizing the cerebral venous system. METHODS: Mapping and radiofrequency ablation was performed via the venous system in two pigs. RESULTS: Eight targeted sites were successfully accessed and four targeted sites successfully ablated via the central cerebral venous network. CONCLUSION: Electrophysiological mapping and radiofrequency ablation of the cerebral cortex can be performed via the cerebral veins.

A systematical analysis of in vivo contact forces on virtual catheter tip/tissue surface contact during cardiac mapping and intervention.

INTRODUCTION: While catheter tip/tissue contact has been shown to be an important determinant of ablative lesions in in vitro studies, the impact of contact on the outcomes of mapping and ablation in the intact heart has not been evaluated. METHODS AND RESULTS: Twelve dogs underwent atrial ablation guided by the Senesitrade mark robotic catheter remote control system. After intracardiac ultrasound (ICE) validation of contact force measured by an in-line mechanical sensor, the relationship between contact force and individual lesion formation was established during irrigated-tipped ablation (flow 17 mL/sec) at 15 watts for 30 seconds. Minimal contact by ICE correlated with force of 4.7 +/- 5.8 grams, consistent contact 9.9 +/- 8.6 grams and tissue tenting produced 25.0 +/- 14.0 grams. Conversely, catheter tip/tissue contact by ICE was predicted by contact force. A contact force of 10-20 and > or =20 grams generated full-thickness, larger volume ablative lesions than that created with <10 grams (98 +/- 69 and 89 +/- 70 mm(3) vs 40 +/- 42 mm(3), P < 0.05). Moderate (10 grams) and marked contact (15-20 grams) application produced 1.5 X greater electroanatomic map volumes that were seen with minimal contact (5 grams) (26 +/- 3 cm(3) vs 33 +/- 6, 39 +/- 3 cm(3), P < 0.05). The electroanatomic map/CT merge process was also more distorted when mapping was generated at moderate to marked contact force. CONCLUSION: This study shows that mapping and ablation using a robotic sheath guidance system are critically dependent on generated force. These findings suggest that ablative lesion size is optimized by the application of 10-20 grams of contact force, although mapping requires lower-force application to avoid image distortions.

Mechanism of tissue heating during high intensity focused ultrasound pulmonary vein isolation: implications for atrial fibrillation ablation efficacy and phrenic nerve protection.

INTRODUCTION: The purpose of this study was to examine tissue temperatures around pulmonary veins (PVs) during high intensity focused ultrasound (HIFU) balloon ablation for atrial fibrillation. The thermodynamics and extent of PV and phrenic nerve (PN) heating during HIFU ablation have not been established. METHODS AND RESULTS: Tissue temperatures were recorded from epicardial thermocouples at right superior (RS) PV orifice and PN in eight dogs undergoing 51 RSPV HIFU ablations (40 seconds, 40 W). Maximum tissue temperatures, reflected by 288 recording profiles, were negatively correlated with distance from balloon surface (r =-0.79, P < 0.001). Average maximum RSPV temperature was 56.8 +/- 16.8 degrees C (distance: 6.6 +/- 4.1 mm), resulting in full-thickness, circumferential PV isolation in 7 of 8 animals. Direct local mechanical heating restricted to the focused ultrasound zone showed temperature rise to > or =50 degrees C within 10 seconds to a maximum temperature of 82.6 +/- 8.9 degrees C (n = 31). Apparent conductive heating showed gradual heating patterns (<50 degrees C within 10 seconds) at greater distance. PN temperature at all recording sites was 45.0 +/- 11.3 degrees C (distance: 9.2 +/- 5.0 mm). Intentional PN injury (10 of 51 [19.6%] ablations), occurred at 63.7 +/- 16.0 degrees C with closest distance of 4.4 +/- 2.5 mm, which was closer than in PNs without injury (7.3 +/- 4.3 mm, P = 0.005). CONCLUSIONS: HIFU ablation is highly effective in generating temperatures needed for full-thickness, circumferential ablation through rapid direct mechanical heating. Gradual heating of surrounding tissue supports the presence of conductive heating. This study also discloses direct HIFU effects as the mechanism of PN injury occurring within 4-7 mm from balloon surface.

Three-dimensional ultrasound for image-guided mapping and intervention: methods, quantitative validation, and clinical feasibility of a novel multimodality image mapping system.

BACKGROUND: Multiple factors create discrepancies between electroanatomic maps and merged, preacquired computed tomographic images used in guiding atrial fibrillation ablation. Therefore, a Carto-based 3D ultrasound image system (Biosense Webster Inc) was validated in an animal model and tested in 15 atrial fibrillation patients. METHODS AND RESULTS: Twelve dogs underwent evaluation using a newly developed Carto-based 3D ultrasound system. After fiducial clip markers were percutaneously implanted at critical locations in each cardiac chamber, 3D ultrasound geometries, derived from a family of 2D intracardiac echocardiographic images, were constructed. Point-source error of 3D ultrasound-derived geometries, assessed by actual real-time 2D intracardiac echocardiographic clip sites, was 2.1+/-1.1 mm for atrial and 2.4+/-1.2 mm for ventricular sites. These errors were significantly less than the variance on CartoMerge computed tomographic images (atria: 3.3+/-1.6 mm; ventricles: 4.8+/-2.0 mm; P<0.001 for both). Target ablation at each clip, guided only by 3D ultrasound-derived geometry, resulted in lesions within 1.1+/-1.1 mm of the actual clips. Pulmonary vein ablation guided by 3D ultrasound-derived geometry resulted in circumferential ablative lesions. Mapping in 15 patients produced modestly smaller 3D ultrasound versus electroanatomic map left atrial volumes (98+/-24 cm(3) versus 109+/-25 cm(3), P<0.05). Three-dimensional ultrasound-guided pulmonary vein isolation and linear ablation in these patients were successfully performed with confirmation of pulmonary vein entrance/exit block. CONCLUSIONS: These data demonstrate that 3D ultrasound images seamlessly yield anatomically accurate chamber geometries. Image volumes from the ultrasound system are more accurate than possible with CartoMerge computed tomographic imaging. This clinical study also demonstrates the initial feasibility of this guidance system for ablation in patients with atrial fibrillation.