ABSTRACT
AIMS: The ultra-low-temperature cryoablation (ULTC) ablation system using -196°C N2 cryogen has been reported to create lesions with freeze duration-dependent depth titratable to over 10â mm with minimum attenuation by scar. Cryocure-VT (NCT04893317) was a first-in-human clinical trial evaluating the safety and efficacy of a novel, purpose-built ULTC catheter in endocardial ablation of scar-dependent ventricular tachycardias (VTs). METHODS AND RESULTS: This prospective, multi-centre study enrolled patients referred for de novo or second ablations of recurrent monomorphic VT of both ischaemic and non-ischaemic aetiologies. Primary safety and efficacy endpoints of the study were freedom from device- or procedure-related major adverse events (MAEs) up to 30 days post-ablation, acute non-inducibility of clinical VTs at the end of the procedure, and freedom from sustained VT or implantable defibrillator intervention at 6 months. Ultra-low-temperature cryoablation was performed in 64 patients (age 67 ± 11 years, 78% ischaemic, ejection fraction = 35 ± 10%) at 9 centres. The primary acute effectiveness endpoint was achieved in 94% (51/54) of patients in whom post-ablation induction was attempted. There were no protocol-defined MAEs; four procedure-related serious adverse events resolved without clinical sequelae. At 6-month follow-up, 38 patients (60.3%) remained VT-free, and freedom from defibrillator shock was 81.0%, with no significant difference between ischaemic and non-ischaemic cohorts. In 47 patients with defibrillator for at least 6 months prior to the ablation, the VT burden was reduced from median of 4, inter-quartile range (IQR, 1-9) to 0, IQR (0-2). CONCLUSION: In this first-in-human multi-centre experience, endocardial ULTC ablation of monomorphic VT appears safe and effective in patients with both ischaemic-cardiomyopathy and non-ischaemic-cardiomyopathy. CLINICAL TRIAL REGISTRATION: NCT04893317.
Subject(s)
Cardiomyopathies , Catheter Ablation , Cryosurgery , Tachycardia, Ventricular , Aged , Humans , Middle Aged , Cardiomyopathies/complications , Cardiomyopathies/diagnosis , Cardiomyopathies/surgery , Catheter Ablation/adverse effects , Cicatrix/complications , Cryosurgery/adverse effects , Prospective Studies , Tachycardia, Ventricular/diagnosis , Tachycardia, Ventricular/etiology , Tachycardia, Ventricular/surgery , Temperature , Treatment OutcomeABSTRACT
In the last three decades, ablation of atrial fibrillation (AF) has become an evidence-based safe and efficacious treatment for managing the most common cardiac arrhythmia. In 2007, the first joint expert consensus document was issued, guiding healthcare professionals involved in catheter or surgical AF ablation. Mounting research evidence and technological advances have resulted in a rapidly changing landscape in the field of catheter and surgical AF ablation, thus stressing the need for regularly updated versions of this partnership which were issued in 2012 and 2017. Seven years after the last consensus, an updated document was considered necessary to define a contemporary framework for selection and management of patients considered for or undergoing catheter or surgical AF ablation. This consensus is a joint effort from collaborating cardiac electrophysiology societies, namely the European Heart Rhythm Association, the Heart Rhythm Society, the Asia Pacific Heart Rhythm Society, and the Latin American Heart Rhythm Society .
Subject(s)
Atrial Fibrillation , Catheter Ablation , Humans , Atrial Fibrillation/diagnosis , Atrial Fibrillation/surgery , Latin America , Treatment Outcome , Catheters , Asia , Catheter Ablation/adverse effects , Catheter Ablation/methodsABSTRACT
BACKGROUND: Access to pacemakers and defibrillators is problematic in places with limited resources. Resterilization and reuse of implantable cardiac devices obtained post mortem from patients in wealthier nations have been undertaken, but uncertainty around the risk of infection is a concern. METHODS: A multinational program was initiated in 1983 to provide tested and resterilized pacemakers and defibrillators to underserved nations; a prospective registry was established in 2003. Patients who received reused devices in this program were matched in a 1:3 ratio with control patients who received new devices implanted in Canada. The primary outcome was infection or device-related death, with mortality from other causes modeled as a competing risk. RESULTS: Resterilized devices were implanted in 1051 patients (mean [±SD] age, 63.2±18.5 years; 43.6% women) in Mexico (36.0%), the Dominican Republic (28.1%), Guatemala (26.6%), and Honduras (9.3%). Overall, 85% received pacemakers and 15% received defibrillators, with one (55.5%), two (38.8%), or three (5.7%) leads. Baseline characteristics did not differ between these patients and the 3153 matched control patients. At 2 years of follow-up, infections had occurred in 21 patients (2.0%) with reused devices and in 38 (1.2%) with new devices (hazard ratio, 1.66; 95% confidence interval, 0.97 to 2.83; P = 0.06); there were no device-related deaths. The most common implicated pathogens were Staphylococcus aureus and S. epidermidis. CONCLUSIONS: Among patients in underserved countries who received a resterilized and reused pacemaker or defibrillator, the incidence of infection or device-related death at 2 years was 2.0%, an incidence that did not differ significantly from that seen among matched control patients with new devices in Canada.
Subject(s)
Defibrillators, Implantable/adverse effects , Equipment Reuse , Infections/etiology , Pacemaker, Artificial/adverse effects , Adult , Aged , Case-Control Studies , Developing Countries , Female , Follow-Up Studies , Humans , Incidence , Infections/epidemiology , Kaplan-Meier Estimate , Male , Middle Aged , Mortality , Risk Factors , SterilizationABSTRACT
AIMS: To allow timely initiation of anticoagulation therapy for the prevention of stroke, the European guidelines on atrial fibrillation (AF) recommend remote monitoring (RM) of device-detected atrial high-rate episodes (AHREs) and progression of arrhythmia duration along pre-specified strata (6 min <1â h, 1 h <24 h, ≥ 24â h). We used the MATRIX registry data to assess the capability of a single-lead implantable cardioverter-defibrillator (ICD) with atrial sensing dipole (DX ICD system) to follow this recommendation in patients with standard indication for single-chamber ICD. METHODS AND RESULTS: In 1841 DX ICD patients with daily automatic RM transmissions, electrograms of first device-detected AHREs per patient in each duration stratum were adjudicated, and the corresponding positive predictive values (PPVs) for the detections to be true atrial arrhythmia were calculated. Moreover, the incidence and progression of new-onset AF was assessed in 1451 patients with no AF history. A total of 610 AHREs ≥6â min were adjudicated. The PPV was 95.1% (271 of 285) for episodes 6min <1â h, 99.6% (253/254) for episodes 1 h <24â h, 100% (71/71) for episodes ≥24â h, or 97.5% for all episodes (595/610). The incidence of new-onset AF was 8.2% (119/1451), and in 31.1% of them (37/119), new-onset AF progressed to a higher duration stratum. Nearly 80% of new-onset AF patients had high CHA2DS2-VASc stroke risk, and 70% were not on anticoagulation therapy. Age was the only significant predictor of new-onset AF. CONCLUSION: A 99.7% detection accuracy for AHRE ≥1â h in patients with DX ICD systems in combination with daily RM allows a reliable guideline-recommended screening for subclinical AF and monitoring of AF-duration progression.
Subject(s)
Atrial Fibrillation , Defibrillators, Implantable , Stroke , Humans , Atrial Fibrillation/diagnosis , Atrial Fibrillation/therapy , Atrial Fibrillation/epidemiology , Defibrillators, Implantable/adverse effects , Heart Atria , Stroke/diagnosis , Stroke/epidemiology , Stroke/etiology , AnticoagulantsABSTRACT
INTRODUCTION: Expert societies recently published strong recommendations to reduce the exposure of patients and staff to ionizing radiation (IR) during interventional and electrophysiology (EP) procedures. However, adherence to these guidelines remains difficult and the impact of implementing such recommendations is poorly characterized. METHODS AND RESULTS: We conducted a single-center cohort study to quantify radiation exposure over time in three EP laboratories at the Montreal Heart Institute during 5,546 consecutive procedures from 2012 to 2015 by 11 primary operators. Overall, 2,618 (47.2%) procedures were catheter-based and 2,928 (52.8%) were device interventions. Interventions to reduce radiation exposure included educational initiatives to raise awareness (i.e., limiting cine acquisition, patient position, table height), slower frame rate, lower radiation dose per pulse, collimation, and integration with 3-D mapping systems and/or MediGuide technology. An 85% reduction in IR exposure was observed from 2012 to 2015, with the mean dose-area-product (DAP) decreasing from 7.65 ± 0.05 Gy·cm2 to 1.15 ± 0.04 Gy·cm2 (P < 0.001). This was true for catheter-based procedures (mean DAP 16.99 ± 0.08 to 2.00 ± 0.06 Gy·cm2 , P < 0.001) and device interventions (mean DAP 4.18 ± 0.06 to 0.64 ± 0.05 Gy·cm2 , P < 0.001). The median effective dose of IR recorded per quarter by 282 cervical dosimeters on EP staff decreased from 0.57 (IQR 0.18, 1.03) mSv in 2012 to 0.00 (IQR 0.00, 0.19) mSv in 2015, P < 0.001. CONCLUSION: Enforcing good clinical practices with simple measures and low-dose fluoroscopy settings are highly effective in reducing IR exposure in the EP lab. These promising results should encourage other EP labs to adopt similar protective measures.
Subject(s)
Cardiac Catheterization/methods , Electrophysiologic Techniques, Cardiac , Occupational Exposure/prevention & control , Prosthesis Implantation/methods , Radiation Dosage , Radiation Exposure/prevention & control , Radiography, Interventional/methods , Cardiac Catheterization/adverse effects , Cardiac Catheterization/instrumentation , Electrophysiologic Techniques, Cardiac/adverse effects , Humans , Occupational Exposure/adverse effects , Occupational Health , Prosthesis Implantation/adverse effects , Prosthesis Implantation/instrumentation , Protective Factors , Radiation Exposure/adverse effects , Radiation Protection , Radiography, Interventional/adverse effects , Retrospective Studies , Risk Assessment , Risk Factors , Time FactorsABSTRACT
Aims: Achieving adequate catheter tip-tissue contact is essential for delivering robust radiofrequency (RF) ablation lesions. We measured the contact force generated by a remote magnetic-guided catheter navigation system. Methods and results: A plexiglass model with an integrated scale was fashioned to mimic transvenous and retrograde access to sites in the right atrium and right and left ventricles. An 8 Fr RF ablation catheter was steered by remote magnetic guidance at fields of 0.08 and 0.10 T, with and without a long sheath positioned at the entrance of the chamber. Ten contact force readings were taken at each setting, with the scale recalibrated prior to each measurement. Generalized estimating equations were used to compare contact force measurements while adjusting for the non-independent data structure. A total of 240 contact force measurements were taken. Without a long sheath, contact forces with magnetic fields of 0.10 T (n = 60) and 0.08 T (n = 60) were similar (6.1 ± 1.4 g vs. 6.0 ± 1.3 g, P = 0.089). Contact forces were not significantly different with simulated transvenous (n = 80) and retrograde aortic (n = 40) approaches (6.2 ± 1.4 g vs. 5.7 ± 1.2 g, P = 0.132). The contact force increased substantially with a long sheath (P < 0.001) and was significantly higher with 0.10 T (n = 60) vs. 0.08 T (n = 60) fields (20.4 ± 0.6 g vs. 18.0 ± 0.5 g, P < 0.001). Conclusion: Magnetic fields of 0.08 and 0.10 T provide stable catheter contact forces, as reflected by the small variability between measurements. The average contact force is approximately 6 g without a sheath and increases to 20 g with a long sheath positioned at the entrance of the chamber of interest.
Subject(s)
Cardiac Catheterization/methods , Catheter Ablation/methods , Heart Atria/surgery , Heart Ventricles/surgery , Magnetics/methods , Surgery, Computer-Assisted/methods , Cardiac Catheterization/instrumentation , Cardiac Catheters , Catheter Ablation/instrumentation , Heart Atria/anatomy & histology , Heart Ventricles/anatomy & histology , Humans , Magnetics/instrumentation , Magnets , Models, Anatomic , Models, Cardiovascular , Pressure , Surgery, Computer-Assisted/instrumentation , Transducers, PressureABSTRACT
INTRODUCTION: The standard 4-minute application time for transcatheter cryoablation was determined in the 1990s when the system employed less potent chlorofluorocarbon refrigerants. The current refrigerant, nitrous oxide, generates substantially colder temperatures, with a faster cooling rate. METHODS AND RESULTS: We conducted a preclinical study on 32 mongrel dogs with stratified randomization of right atrial, right ventricular, and left ventricular chambers to 2-minute versus 4-minute application times using 8-mm electrode tip cryocatheters (Freezor Max, Medtronic CryoCath LP, Montreal, Canada). Animals were sacrificed one month after the procedure. Three-dimensional morphometric analyses were conducted in a blinded fashion. A total of 193 identified ablation lesions were processed for histological analyses, 102 with 2-minute applications and 91 with 4-minute applications. Ablation lesion surface area (167.8 ± 21.6 mm2 vs. 194.3 ± 22.6 mm2 , P = 0.40), maximum depth (4.4 ± 0.2 mm vs. 4.5 ± 0.2 mm, P = 0.71), and volume (125.7 ± 69.5 mm3 vs. 141.0 ± 83.5 mm3 , P = 0.25) were similar between groups. Overall, 90.2% of ablation lesions in the right atrium were transmural, 45.6% in the right ventricle, and 2.4% in the left ventricle, with no differences between 2-minute and 4-minute application times (P = 0.55). Thrombus was detected on the endocardial surface of 0.0% and 3.3% of ablation lesions created with 2-minute and 4-minute application times, respectively (P = 0.10). CONCLUSION: Single 2-minute and 4-minute application times result in catheter ablation lesions of similar size using the modern cryoablation system with nitrous oxide as a refrigerant. While these findings suggest the potential to reduce the standard 4-minute application time, further studies are required to compare clinical efficacy.
Subject(s)
Cardiac Catheterization/methods , Cold Temperature , Cryosurgery/methods , Heart Atria/surgery , Heart Ventricles/surgery , Nitrous Oxide/pharmacology , Animals , Dogs , Heart Atria/pathology , Heart Ventricles/pathology , Models, Animal , Time FactorsABSTRACT
AIMS: It remains unknown whether contact force (CF) sensing technology is of value for cavotricuspid isthmus (CTI) ablation. We prospectively evaluated procedural parameters and outcomes of CF-guided vs. CF-blinded CTI ablation for typical atrial flutter (AFL). METHODS AND RESULTS: A total of 70 consecutive patients (62.5 ± 10.9 years) undergoing CTI ablation for AFL were prospectively enrolled, 35 in CF-blinded and 35 in CF-guided groups. A CF-sensing catheter (power 25-35 W) was used in all. In the CF-guided group, CF target range was 10-25 g, whereas in the CF-blinded group, the operator was blinded to CF. The isthmus was divided into anterior, middle, and posterior segments for region-specific CF analysis. The procedural endpoint of bidirectional isthmus block following a 20-min observation period was achieved in all. A trend towards lower fluoroscopy and procedure duration was observed when the CF-guided group was compared with the CF-blinded group. The total radiofrequency (RF) energy delivery time required to achieve bidirectional block was significantly lower in the CF-guided vs. CF-blinded group [10.0 min (IQR 8.3;15.1) vs. 15.9 min (IQR 9.6;24.7), P= 0.0020], with a significant inverse correlation between CF and total RF delivery time (r = -0.36; P= 0.0027). Mean CF measurements significantly increased from anterior to posterior anatomical zones of CTI in the CF-blinded group (ANOVA P= 0.0466). CONCLUSIONS: Catheter ablation of AFL guided by real-time CF assessment results in a significant reduction in total RF delivery time. Real-time CF measurements facilitate the maintenance of homogenous efficient contact all along the CTI, particularly in the anterior segment where CF is generally lower.
Subject(s)
Atrial Flutter/surgery , Cardiac Catheters , Catheter Ablation/instrumentation , Transducers, Pressure , Action Potentials , Aged , Analysis of Variance , Atrial Flutter/diagnosis , Atrial Flutter/physiopathology , Catheter Ablation/adverse effects , Catheter Ablation/methods , Chi-Square Distribution , Equipment Design , Female , Heart Rate , Humans , Male , Middle Aged , Prospective Studies , Risk Factors , Time Factors , Treatment OutcomeABSTRACT
INTRODUCTION: Cardiac resynchronization therapy (CRT) implant procedures are often complex and prolonged, resulting in substantial ionizing radiation (IR) exposure to the patient and operator. We assessed the impact of lower-dose fluoroscopy settings and a sensor-based electromagnetic tracking system (MediGuide™, MDG) on reducing IR exposure during CRT implantation. METHODS: A single-center 2-group cohort study was conducted on 348 consecutive patients, age 66.4 ± 11.0 years, 80.4% male, with CRT implant procedures from 2013 to 2015. Patients were arbitrarily assigned to MDG (N = 239) versus no MDG (N = 109) guidance. Lower-dose fluoroscopy settings were adopted in January 2015 (3 instead of 6 fps; 23 instead of 40 nGy/pulse; N = 101). RESULTS: Overall, MDG was associated with an 82.1% reduction in IR exposure (393 µGray·m2 vs. 2191 µGray·m2 , P < 0.001). Lower-dose fluoroscopy resulted in a 59.5% reduction in IR-exposure without MDG (1055 µGray·m2 vs. 2608 µGray·m2 , P < 0.001) and 81.8% reduction with MDG (108 µGray·m2 vs. 595 µGray·m2 , P < 0.001). Low-dose fluoroscopy combined with MDG was associated with a 95.9% lower exposure to IR when compared to standard fluoroscopy without MDG (108 µGray·m2 vs. 2608 µGray·m2 , P < 0.001). Procedures with MDG were shorter (96 minutes vs. 123 minutes, P < 0.001) and associated with a trend towards a higher success rate (94.6% vs. 89.0%, P = 0.062), with fewer coronary sinus cannulation failures (2.1% vs. 6.4%, P = 0.040). CONCLUSION: Low-dose fluoroscopy settings are highly effective (>50%) in reducing IR exposure during CRT implant procedures. When combined with MDG, >95% reduction in IR exposure is achieved. Moreover, MDG shortens procedural duration and may improve acute procedural outcomes.
ABSTRACT
INTRODUCTION: Rate and rhythm control strategies for atrial fibrillation (AF) are not always effective or well tolerated in patients with congestive heart failure (CHF). We assessed reasons for treatment failure, associated characteristics, and effects on survival. METHODS AND RESULTS: A total of 1,376 patients enrolled in the AF-CHF trial were followed for 37 ± 19 months, 206 (15.0%) of whom failed initial therapy leading to crossover. Rhythm control was abandoned more frequently than rate control (21.0% vs. 9.1%, P < 0.0001). Crossovers from rhythm to rate control were driven by inefficacy, whereas worsening heart failure was the most common reason to crossover from rate to rhythm control. In multivariate analyses, failure of rhythm control was associated with female sex, higher serum creatinine, functional class III or IV symptoms, lack of digoxin, and oral anticoagulation. Factors independently associated with failure of rate control were paroxysmal (vs. persistent) AF, statin therapy, and presence of an implantable cardioverter-defibrillator. Crossovers were not associated with cardiovascular mortality (hazard ratio [HR] 1.11 from rhythm to rate control; 95% confidence interval [95% CI, 0.73-1.73]; P = 0.6069; HR 1.29 from rate to rhythm control; 95% CI, 0.73-2.25; P = 0.3793) or all-cause mortality (HR 1.16 from rhythm to rate control, 95% CI [0.79-1.72], P = 0.4444; HR 1.15 from rate to rhythm control, 95% [0.69, 1.91], P = 0.5873). CONCLUSIONS: Rhythm control is abandoned more frequently than rate control in patients with AF and CHF. The most common reasons for treatment failure are inefficacy for rhythm control and worsening heart failure for rate control. Changing strategies does not impact survival.
Subject(s)
Atrial Fibrillation/complications , Atrial Fibrillation/therapy , Heart Failure/complications , Heart Failure/therapy , Heart Rate , Aged , Anti-Arrhythmia Agents/therapeutic use , Anticoagulants/therapeutic use , Arrhythmias, Cardiac/physiopathology , Arrhythmias, Cardiac/therapy , Atrial Fibrillation/mortality , Creatinine/blood , Defibrillators, Implantable , Digoxin/therapeutic use , Disease Progression , Female , Follow-Up Studies , Heart Failure/mortality , Humans , Hydroxymethylglutaryl-CoA Reductase Inhibitors/therapeutic use , Male , Middle Aged , Sex Factors , Treatment FailureABSTRACT
AIMS: Electrical reconnection after pulmonary vein (PV) isolation is associated with atrial fibrillation (AF) recurrence. Reconnection may already develop within a 30 min waiting period and may only occur as dormant conduction (DC) revealed by adenosine infusion. This study determines incidence and predictors of DC after cryoballoon ablation incorporating a 30 min waiting period and the effect of treating this 'late' DC on 1 year AF-recurrence. METHODS AND RESULTS: Consecutive patients scheduled for a first ablation were prospectively included. Intravenous adenosine was administered 30 min after PV isolation to unmask DC (adenosine+). Additional applications were performed to abolish DC. Atrial fibrillation recurrence was evaluated after 3, 6, and 12 months with ECG and 24 h Holter recordings. Results were compared with a prior group of consecutive patients that underwent cryoablation without DC testing (adenosine-). The adenosine+ group consisted of 36 patients (78% male, 61 ± 10 years, paroxysmal AF 86%). ***Dormant conduction was found in 42% of patients (15/36) and 14% of PVs (20/143). Multivariate analysis showed that PV isolation during the first freeze independently reduced DC risk (OR = 0.064, P < 0.01). After 12 ± 1 months, 11 (83%) of adenosine+ patients had no AF-recurrences, compared with 37 (60%) of adenosine- patients (n = 62, 70% male, 59 ± 11 years, 90% paroxysmal AF, P = 0.02). Ablation with DC treatment independently reduced the risk of AF-recurrence (OR = 0.26, P = 0.02). CONCLUSION: Incorporating a 30-min waiting period after cryoballoon ablation increases the incidence of DC compared with previous results. Absence of PV isolation during the first freeze is associated with an increased risk of late DC. Treatment of this DC seems to improve outcome.
Subject(s)
Adenosine/administration & dosage , Anti-Arrhythmia Agents/administration & dosage , Atrial Fibrillation/epidemiology , Atrial Fibrillation/surgery , Postoperative Complications , Pulmonary Veins/surgery , Aged , Cryosurgery/methods , Electrocardiography, Ambulatory , Female , Heart Rate/drug effects , Humans , Logistic Models , Male , Middle Aged , Multivariate Analysis , Prognosis , Recurrence , Treatment OutcomeABSTRACT
BACKGROUND: Cardiac resynchronization therapy (CRT) implant procedures are often complex and prolonged, resulting in significant ionizing radiation (IR) exposure to the patient and operator. We report our early experience working with a novel sensor-based electromagnetic tracking system (MediGuide™, MDG, St. Jude Medical Inc., St. Paul, MN, USA), in terms of procedural IR exposure reduction. METHODS AND RESULTS: Information regarding patient demographics, procedural details, procedural duration, and IR exposure were prospectively collected on 130 consecutive CRT procedures performed between January 2013 and January 2014. Sixty procedures were performed with MDG guidance, and 70 were performed without MDG guidance. Despite a nonsignificant trend toward shorter procedure duration with the use of MDG (120 minutes vs 138 minutes with non-MDG, P = 0.088), a 66% reduction in total IR exposure (median 769 µGray · m(2) vs 2,608 µGray · m(2), P < 0.001) was found. This reduction was primarily driven by a >90% reduction in IR dose required to cannulate the coronary sinus (median 80 µGray · m(2) vs 922 µGray · m(2), P < 0.001), and to a lesser extent from a reduction in IR dose required for LV lead placement (median 330 µGray·m(2) vs 737 µGray · m(2), P = 0.059). In addition, a significant learning curve effect was observed with a significantly shorter procedural duration for the last 15 cases compared to the first 15 cases (median 98 minutes vs 175 minutes, P < 0.001). CONCLUSION: The nonfluoroscopic MDG positioning system is associated with a dramatic reduction in exposure to IR during CRT implant procedures, with a 90% decrease in the IR dose required to cannulate the coronary sinus. A steep learning curve was quantified.
Subject(s)
Cardiac Resynchronization Therapy Devices , Prosthesis Implantation/methods , Radiation Injuries/prevention & control , Aged , Electromagnetic Radiation , Female , Fluoroscopy , Humans , Male , Middle Aged , Prospective Studies , Surgery, Computer-AssistedABSTRACT
BACKGROUND: Fluoroscopic guidance is used to position catheters during cardiac ablation. We evaluated the impact of a novel nonfluoroscopic sensor-guided electromagnetic navigation system (MG) on radiation exposure during catheter ablation of atrial fibrillation (AF) or atrial flutter (AFL). METHODS: A total of 134 consecutive patients referred for ablation of AF (n = 44) or AFL (n = 90) ablation were prospectively enrolled. In one group the MG system was used for nonfluoroscopic catheter positioning, whereas in the conventional group standard fluoroscopy was utilized. Fluoroscopy times were assessed for each stage of procedure and total radiation exposure was quantified. RESULTS: Patient characteristics were similar between the groups. The procedural end point was achieved in all. Median (interquartile range [IQR]) fluoroscopy times were 12.5 minutes (7.6, 17.4) MG group versus 21.5 minutes (15.3, 23.0) conventional group (P < 0.0001) for AF ablation, and 0.8 minutes (0.4, 2.5) MG group versus 9.9 minutes (5.1, 22.5) conventional group (P < 0.0001) for AFL ablation. Median (IQR) total radiation exposure (µGy·m(2)) was 1,107 (906, 2,033) MG group versus 2,835 (1,688, 3,855) conventional group (P = 0.0001) for AF ablation, and 161 (65, 537) MG group versus 1,651 (796, 4,569) conventional group (P < 0.0001) for AFL ablation. No difference in total procedural time was seen. CONCLUSIONS: The use of a novel nonfluoroscopic catheter tracking system is associated with a significant reduction in radiation exposure during AF and AFL ablation (61% and 90% reduction, respectively). In the era of heightened awareness of the importance of radiation reduction, this system represents a safe and efficient tool to decrease radiation exposure during electrophysiological ablation procedures.
Subject(s)
Atrial Fibrillation/surgery , Atrial Flutter/surgery , Cardiac Catheters , Catheter Ablation/methods , Radiation Exposure/analysis , Radiography, Interventional/instrumentation , Atrial Fibrillation/diagnostic imaging , Atrial Flutter/diagnostic imaging , Equipment Design , Equipment Failure Analysis , Humans , Radiation Dosage , Radiation Protection , Radiography, Interventional/methods , Reproducibility of Results , Sensitivity and Specificity , Treatment OutcomeABSTRACT
BACKGROUND: Invasively measured maximum increase in left ventricular pressure (LV dP/dtmax) has been used to assess biventricular (BiV) pacing. We quantified extracardiac factors contributing to its variability, and developed a protocol to minimize these effects in an acute pacing experiment. METHODS AND RESULTS: Continuous pressure was recorded by a guidewire sensor placed in the LV. Four to six test pacing interventions were performed, each repeated 3 times and followed by a baseline pacing configuration. Maximum increase in LV dP/dtmax from any measurement of BiV pacing was median 20.3% in 25 patients, compared with BiV pacing off. When directly comparing sequential measurements with BiV pacing on and off, median increase was 7.4%. Noncardiac sources of modulation included respiratory variation (6.4%), drift from first to last baseline measurement (5.0%), and discrepancy among repeated recordings of the same pacing intervention (3.3%). Comparing test interventions to interleaved baseline measurements reduced discrepancy among recordings to 2.1%; P < .001. CONCLUSIONS: With repeated measurements of baseline state, and by comparing test interventions only to baseline measurements performed before and after, it is possible to minimize extracardiac factors and focus on the effects of test pacing interventions.
Subject(s)
Cardiac Resynchronization Therapy/methods , Hemodynamics/physiology , Research Design/standards , Ventricular Dysfunction, Left/physiopathology , Ventricular Dysfunction, Left/therapy , Aged , Female , Humans , Male , Middle Aged , Time Factors , Treatment Outcome , Ventricular Dysfunction, Left/diagnosisABSTRACT
Background: Cardiac radioablation is a new treatment for patients with refractory ventricular tachycardia (VT). The target for cardiac radioablation is subject to cardiorespiratory motion (CRM), the heart's movement with breathing and cardiac contraction. Data regarding the magnitude of target CRM are limited but are highly important for treatment planning. Objectives: The study sought to assess CRM amplitude by using ablation catheter geometrical data. Methods: Electroanatomic mapping data of patients undergoing catheter ablation for VT at 3 academic centers were exported. The spatial position of the ablation catheter as a function of time while in contact with endocardium was analyzed and used to quantify CRM. Results: Forty-four patients with ischemic and nonischemic cardiomyopathy and VT contributed 1364 ablation lesions to the analysis. Average cardiac and respiratory excursion were 1.62 ± 1.21 mm and 12.12 ± 4.10 mm, respectively. The average ratio of respiratory to cardiac motion was approximately 11:1. CRM was greatest along the craniocaudal axis (9.66 ± 4.00 mm). Regional variations with respect to respiratory and cardiac motion were observed: basal segments had smaller displacements vs midventricular and apical segments. Patient characteristics (previous cardiac surgery, height, weight, body mass index, and left ventricular ejection fraction) had a statistically significant, albeit clinically moderate, impact on CRM. Conclusion: CRM is primarily determined by respiratory displacement and is modulated by the location of the target and the patient's biometric characteristics. The patient-specific quantification of CRM may allow to decrease treatment volume and reduce radiation exposure of surrounding organs at risk while delivering the therapeutic dose to the target.
ABSTRACT
In the last three decades, ablation of atrial fibrillation (AF) has become an evidence-based safe and efficacious treatment for managing the most common cardiac arrhythmia. In 2007, the first joint expert consensus document was issued, guiding healthcare professionals involved in catheter or surgical AF ablation. Mounting research evidence and technological advances have resulted in a rapidly changing landscape in the field of catheter and surgical AF ablation, thus stressing the need for regularly updated versions of this partnership which were issued in 2012 and 2017. Seven years after the last consensus, an updated document was considered necessary to define a contemporary framework for selection and management of patients considered for or undergoing catheter or surgical AF ablation. This consensus is a joint effort from collaborating cardiac electrophysiology societies, namely the European Heart Rhythm Association, the Heart Rhythm Society (HRS), the Asia Pacific HRS, and the Latin American HRS.
Subject(s)
Atrial Fibrillation , Catheter Ablation , Consensus , Societies, Medical , Atrial Fibrillation/surgery , Catheter Ablation/methods , Humans , Europe , Latin America , AsiaABSTRACT
In the last three decades, ablation of atrial fibrillation (AF) has become an evidence-based safe and efficacious treatment for managing the most common cardiac arrhythmia. In 2007, the first joint expert consensus document was issued, guiding healthcare professionals involved in catheter or surgical AF ablation. Mounting research evidence and technological advances have resulted in a rapidly changing landscape in the field of catheter and surgical AF ablation, thus stressing the need for regularly updated versions of this partnership which were issued in 2012 and 2017. Seven years after the last consensus, an updated document was considered necessary to define a contemporary framework for selection and management of patients considered for or undergoing catheter or surgical AF ablation. This consensus is a joint effort from collaborating cardiac electrophysiology societies, namely the European Heart Rhythm Association, the Heart Rhythm Society, the Asia Pacific Heart Rhythm Society, and the Latin American Heart Rhythm Society.
ABSTRACT
BACKGROUND: There is no scientific literature that examines radiofrequency (RF) interference from Smart Meters with cardiac implantable electronic devices (CIEDs). The objective of this in vitro study was to assess any potential interference with Medtronic CIEDs (Medtronic Inc., Minneapolis, MN, USA). METHODS: In the Quebec testing, five models of Medtronic CIEDs were placed in an acrylic cylinder filled with a saline solution and faced a Landis+Gyr Smart Meter or Router (Landis+Gyr AG, Zug, Switzerland). The distance between CIEDs and the meter casing or router antenna was 10 cm. The Meter's normal operating conditions were modified to artificially set the number of impulsions at an abnormally high level (one, two, and three impulses per second). Each scenario was repeated one to five times, for 1 minute each. In the U.S. testing, 6 cm and 15 cm (â¼2.25' and â¼6') separated the six models of Medtronic CIEDs from the Schlumberger Smart Meter (Itron Inc., Liberty Lake, WA, USA), which generally sent out a 96-bit Standard Consumption Message over 3 seconds. The transmission varied in frequencies along with the interval between cycles. RESULTS: A total of 6,966 RF transmissions were completed during the 34 tests conducted in Quebec. In the United States, the CIED was exposed to the meter for 10 minutes to provide a minimum of 200 completed RF transmissions. No interference was observed in worst-case scenarios (testing of meters and CIEDs at their performance limits). CONCLUSIONS: Landis+Gyr Smart Meters/Routers and Schlumberger Smart Meters do not interfere with the functioning of the Medtronic CIEDs tested, when placed, respectively, 10 cm and 6 cm and 15 cm apart.
Subject(s)
Artifacts , Computer Communication Networks/instrumentation , Defibrillators, Implantable , Electric Power Supplies , Equipment Failure , Pacemaker, Artificial , Wireless Technology/instrumentation , Electricity , Equipment Failure Analysis/methods , QuebecABSTRACT
BACKGROUND: Robotic magnetic navigation (RMN) has emerged as a potential solution to overcome challenges associated with catheter ablation of arrhythmias in patients with congenital heart disease (CHD). OBJECTIVES: To assess safety and efficacy of RMNguided catheter ablation in patients with CHD. DESIGN AND METHODS: A systematic review and pooled analysis was conducted on patients with CHD who underwent RMNguided catheter ablation. Random effects models were used to generate pooled estimates with the inverse variance method used for weighting studies. RESULTS: Twentyfour nonoverlapping records included 167 patients with CHD, mean age 36.5 years, 44.6% female. Type of CHD was simple in 27 (16.2%), moderate in 32 (19.2%), and complex in 106 (63.5%). A total of 202 procedures targeted 260 arrhythmias, the most common being macroreentrant atrial circuits. The mean procedural duration was 207.5 minutes, with a mean fluoroscopy time of 12.1 minutes. The pooled acute success rate was 89.2% [95% CI (77.8%, 97.4%)]. Freedom from arrhythmia recurrence was 84.5% [95% CI (72.5%, 94.0%)] over a mean follow-up of 24.3 months. The procedural complication rate was 3.5% with no complication attributable to RMN technology. CONCLUSION: RMN-guided ablation appears to be safe and effective across a variety of arrhythmia substrates and types of CHD.