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1.
Heart Rhythm ; 13(7): 1521-6, 2016 07.
Article in English | MEDLINE | ID: mdl-26921762

ABSTRACT

BACKGROUND: Long-term clinical outcomes for atrial fibrillation ablation depend on the creation of durable transmural lesions during pulmonary vein isolation and on substrate modification. Focal conventional radiofrequency (RF) ablation studies have demonstrated that tissue temperature and power are important factors for lesion formation. However, the impact and predictability of temperature and power on contiguous, transmural lesion formation with a phased RF system has not been described. OBJECTIVE: The purpose of this study was to determine the sensitivity, specificity, and predictability of power and temperature to create contiguous, transmural lesions with the temperature-controlled, multielectrode phased RF PVAC GOLD catheter. METHODS: Single ablations with the PVAC GOLD catheter were performed in the superior vena cava of 22 pigs. Ablations from 198 PVAC GOLD electrodes were evaluated by gross examination and histopathology for lesion transmurality and contiguity. Lesions were compared to temperature and power data from the phased RF GENius generator. Effective contact was defined as electrodes with a temperature of ≥50°C and a power of ≥3 W. RESULTS: Eighty-five percent (168 of 198) of the lesions were transmural and 79% (106 of 134) were contiguous. Electrode analysis showed that >30 seconds of effective contact identified transmural lesions with 85% sensitivity (95% confidence interval [CI] 78%-89%), 93% specificity (95% CI 76%-99%), and 99% positive predictive value (95% CI 94%-100%). Sensitivity for lesion contiguity was 95% (95% CI 89%-98%), with 62% specificity (95% CI 42%-78%) and 90% positive predictive value (95% CI 83%-95%). No char or coagulum was observed on the catheter or tissue. CONCLUSION: PVAC GOLD safely, effectively, and predictably creates transmural and contiguous lesions.


Subject(s)
Atrial Fibrillation/surgery , Catheter Ablation , Hot Temperature/adverse effects , Intraoperative Complications/prevention & control , Pulmonary Veins/surgery , Animals , Catheter Ablation/adverse effects , Catheter Ablation/methods , Electrodes/standards , Heart Conduction System/radiation effects , Intraoperative Complications/diagnosis , Intraoperative Complications/etiology , Models, Anatomic , Risk Adjustment/methods , Swine , Time Factors
2.
Circ Arrhythm Electrophysiol ; 6(1): 16-22, 2013 Feb.
Article in English | MEDLINE | ID: mdl-23392585

ABSTRACT

BACKGROUND: Cerebral diffusion-weighted MRI lesions have been observed after catheter ablation of atrial fibrillation. We hypothesized that conditions predisposing to microembolization could be identified using a porcine model of pulmonary vein ablation and an extracorporeal circulation loop. METHODS AND RESULTS: Ablations of the pulmonary veins were performed in 18 swine with echo monitoring. The femoral artery and vein were cannulated and an extracorporeal circulation loop with 2 ultrasonic bubble detectors and a 73-µm filter were placed in series. Microemboli and microbubbles were compared between ablation with an irrigated radiofrequency system (Biosense-Webster) and a phased radiofrequency multielectrode system (pulmonary vein ablation catheter [PVAC], Medtronic, Inc, Carlsbad, CA) in unipolar and 3 blended unipolar/bipolar modes. Animal pathology was examined. The size and number of microbubbles observed during ablation ranged from 30 to 180 µm and 0 to 3253 bubbles per ablation. Microbubble volumes with PVAC (29.1 nL) were greater than with irrigated radiofrequency (0.4 nL; P=0.045), and greatest with type II or III microbubbles on transesophageal echocardiography. Ablation with the PVAC showed fewest microbubbles in the unipolar mode (P=0.012 versus bipolar). The most occurred during bipolar energy delivery with overlap of proximal and distal electrodes (median microbubble volume, 1744 nL; interquartile range, 737-4082 nL; maximum, 19 516 nL). No cerebral MRI lesions were seen, but 2 animals had renal embolization. CONCLUSIONS: Left atrial ablation with irrigated radiofrequency and PVAC catheters in swine is associated with microbubble and microembolus production. Avoiding overlap of electrodes 1 and 10 on PVAC should reduce the microembolic burden associated with this procedure.


Subject(s)
Cardiac Catheters , Catheter Ablation/adverse effects , Catheter Ablation/instrumentation , Embolism/etiology , Pulmonary Veins/surgery , Therapeutic Irrigation/adverse effects , Therapeutic Irrigation/instrumentation , Animals , Diffusion Magnetic Resonance Imaging , Echocardiography, Transesophageal , Electrodes , Embolic Protection Devices , Embolism/diagnosis , Embolism/pathology , Embolism/prevention & control , Embolism, Air/diagnosis , Embolism, Air/etiology , Embolism, Air/pathology , Embolism, Air/prevention & control , Equipment Design , Extracorporeal Circulation , Microbubbles , Models, Animal , Pulmonary Veins/diagnostic imaging , Pulmonary Veins/pathology , Swine , Time Factors , Ultrasonography, Interventional/methods
3.
J Cardiovasc Electrophysiol ; 24(2): 121-8, 2013 Feb.
Article in English | MEDLINE | ID: mdl-23134483

ABSTRACT

INTRODUCTION: Left atrial catheter ablation of the pulmonary veins (PVs) is an established option for patients with atrial fibrillation (AF). Asymptomatic cerebral emboli (ACE) detected by diffusion weighted MRI (DW-MRI) following AF ablation has been reported at varying rates. This variability may be linked to procedural variables and demographic risk factors. Animal studies with the multielectrode pulmonary vein ablation catheter (PVAC) have identified potential sources of emboli, including air introduced during PVAC introduction, inadequate anticoagulation, and high current densities when the distal (E1) and proximal (E10) electrodes are in contact. We sought to evaluate the incidence, size, and number of DW-MRI findings with procedural modifications that potentially reduce the embolic load. METHODS: Thirty-seven AF patients (59 ± 10 years, 73% male, all with paroxysmal AF, left atrial [LA] diameter 44 ± 7 mm, left ventricular ejection fraction 57 ± 7%) underwent MRI sequences preceding ablation, within 24 hours postablation, and at 4-6 weeks. During the procedure all patients were on uninterrupted phenprocoumon, an attempted activated clotting time (ACT) level >300 seconds, had the PVAC introduced under saline, and antral ablation was started with a 2:1 bipolar/unipolar mode. Files from the ablation unit (GENius v14.4) were retrospectively analyzed to determine the relationship between E1 and E10 in close proximity and DW-MRI findings. RESULTS: Post procedure, 10/37 patients (27%) were positive for new DWI cerebral lesions. Nine of 10 patients had a single lesion, and 1/10 patient had 2 lesions. Average lesion size was 3.1 ± 3.9 mm (2-14 mm). One of 10 (10%) had lesions at MRI follow-up. No neurological symptoms were observed. Eighteen of 37 (49%) of procedures had evidence of E1/E10 interaction. In the subgroup of patients with and without E1 and E10 in close proximity, the DW-MRI rate was 8/18 (44%) and 2/19 (11%), respectively (P = 0.029). CONCLUSIONS: The source of positive DW-MRI findings in LA ablation involves several factors. Controlling anticoagulation and careful sheath management helps to reduce the number and size of DW-MRI lesions. With the PVAC catheter, an ablation with the E1 and E10 in close proximity increases the risk of a DW-MRI finding. In the future, electrodes E1 and E10 should be kept apart to help reduce the incidence of acute ACE.


Subject(s)
Atrial Fibrillation/pathology , Atrial Fibrillation/surgery , Catheter Ablation/adverse effects , Intracranial Embolism/etiology , Intracranial Embolism/pathology , Pulmonary Artery/pathology , Pulmonary Artery/surgery , Atrial Fibrillation/complications , Female , Humans , Magnetic Resonance Imaging/methods , Male , Middle Aged , Treatment Outcome
4.
Pacing Clin Electrophysiol ; 25(6): 907-14, 2002 Jun.
Article in English | MEDLINE | ID: mdl-12137342

ABSTRACT

Since children have different activity patterns and exercise responses, uncertainty exists as to whether minute ventilation (MV) sensors designed for adults provide adequate chronotropic response in pediatrics. In particular, high respiratory rates (RR > 48 breaths/min), which are characteristic of the ventilatory response to exercise in children, cannot be sensed by MV rate responsive pacemakers. The purpose of this study was to evaluate the MV sensor rate response of the Medtronic Kappa 400 using exercise data from healthy children in a computer simulation of its rate response algorithm. Thirty-eight healthy children, ages 6-14, underwent a treadmill maximal exercise test. Subjects were divided based on body surface area (BSA) and MV rate response parameters were selected. Respiratory rates and tidal volumes were entered into the Kappa 400 rate response algorithm to calculate sensor-driven rates. Intrinsic heart rate (HR), oxygen uptake, and sensor-driven rates were normalized to HR reserve (HRR), metabolic reserve (MR), and sensor-driven reserve to compare across groups. Linear regression analysis among sensor-driven rate reserve, HRR, and MR was performed as described by Wilkoff. The mean slopes (+/- SD) of the relationships between the sensor-driven rate reserve and HRR were 1.06 +/- 0.34, 1.07 +/- 0.28, and 1.01 +/- 0.19 for children with BSA < 1.10 m2, 1.10 < BSA < 1.40 m2, and BSA > 1.40 m2, respectively. High correlations were found between sensor-drive rates and HR responses and between sensor-drive rates and MV throughout exercise. No significant differences were noted between sensor-drive rates and HR using the Wilkoff model. From this study the authors conclude that: (1) MV is a good physiological parameter to control heart rate and (2) simulated sensor-driven rates closely match intrinsic HRs during exercise in healthy children, which supports the appropriateness of clinical validation in pediatric pacemaker patients.


Subject(s)
Cardiac Pacing, Artificial/methods , Oxygen Consumption/physiology , Pacemaker, Artificial , Pulmonary Ventilation/physiology , Tidal Volume/physiology , Adolescent , Algorithms , Body Surface Area , Child , Circadian Rhythm , Computer Simulation , Exercise Test , Female , Heart Rate , Humans , Male
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