Interpreting Complex Atrial Tachycardia Maps Using Global Atrial VectorsEditorial on: The Utility of a Novel Mapping Algorithm Utilizing Vectors and Global Pattern of Propagation for Scar-Related Atrial TachycardiasMiguel Rodrigo, PhD1-2Sanjiv M. Narayan MD, PhD11Stanford University, Stanford, CA, USA2Electronic Engineering Department, Universitat de Valencia, Spain1500 words excluding title and references12 or less references1-3 tables/figures
Significant changes or cancellation of MCIT could result in limiting access to breakthrough medical technologies that could improve the health and well-being of Medicare beneficiaries. For these reasons, we encourage federal agencies to work together and CMS to implement the MCIT rule without delay to ensure timely access to breakthrough technologies
Leadless Pacing with Mechanical Atrial Sensing and Variable AV ConductionJason Cook, MDTravis D. Richardson, MDFrom Vanderbilt University Medical Center. Nashville, TennesseeCorresponding author:Travis D. Richardson, MDAssistant Professor Cardiac ElectrophysiologyVanderbilt Heart and Vascular Institute1215 21st Ave S. Nashville, TNMedical Center East, South Tower, Suite 5209ph (615) 936-7537fax (615) firstname.lastname@example.orgWord Count:1331Disclosures: The authors report no relevant financial disclosures.Funding: NoneThe MicraTM leadless transcatheter pacing system (Medtronic Inc., Mounds View, MN) has been shown to be an effective alternative to transvenous pacing with excellent implantation success rates and durable long-term performance.1–3 The first generation device provided single chamber right ventricular pacing with rate responsiveness enabled by a 3-axis accelerometer.Recently, the MARVEL 2 study (Micra Atrial tRacking using a Ventricular accELerometer 2) reported the ability of software enhancements to allow a leadless pacemaker to deliver single chamber atrioventricular (AV) synchronized pacing.4 In contrast to dual-chamber transvenous pacemakers which sense atrial electrograms, the MARVEL 2 algorithm adjudicates atrial events using mechanically sensed atrial activity from the 3-axis accelerometer. During initial programming, the relative timing of mechanical events to the ventricular electrogram allows for identification of A3 (passive ventricular filling) and A4 (atrial contraction). Atrial-sensed events are then defined by the A4 signal, and tracking may occur. MARVEL 2 reported VDD pacing was achieved at rest in an impressive 89.2% of patients.The Micra AVTM system’s unique programming includes three basic pacing modes: VDD, VVI and VDIR (Figure 1). Additionally, two mode switch algorithms are available and by default programmed on: the AV conduction mode switch and the activity mode switch. Unlike mode switch algorithms in dual chamber pacing systems, which are intended to avoid inappropriate tracking of atrial arrhythmias, these algorithms are intended to 1) minimize ventricular pacing, and 2) to improve rate support during patient activity respectively.When the AV conduction mode switch algorithm is enabled, the device periodically switches from VDD to VVI at 40 bpm to allow for intrinsic AV conduction. If ventricular sensing occurs above a rate of 40 bpm, in order to reduce right ventricular pacing, VVI 40 programming will continue regardless of the programmed lower rate limit. However, if two of any window of four beats are paced at VVI 40, the device reverts to VDD. Thereafter, reassessments of AV conduction are performed at increasing intervals starting at 2 minutes until either AV conduction is detected or 8 hours is reached at which point subsequent testing occurs at regular 8 hour intervals.The activity mode switch algorithm utilizes the sensor indicated rate in an attempt to ensure adequate ventricular rate support during patient activity regardless of AV conduction. The sensor in the MicraTM is always running. If at any time 1) the sensor indicated rate is above the device programmed ADL rate, and 2) the current ventricular rate is >20 BPM below the sensor rate, the activity mode switch will change the device to VDIR mode with heart rates determined by the sensor. This switch may occur from either the VDD mode or VVI in the setting of AV conduction. The device will revert to VDD mode when the sensor rate drops below the ADL rate.With the added functionality of atrial sensing and the incorporation of the MARVEL 2 algorithms described above, in this issue of the Journal of Cardiovascular Electrophysiology, Garweg et al. examined the pacing behavior of the Micra AVTM in the presence of variable AV conduction, atrial arrhythmias, sinus bradycardia (< 40 bpm), sinus arrhythmia, and periods of atrial and ventricular ectopy (Reference). During the data collection period in MARVEL 2, ECG, electrogram, accelerometer waveforms, and device marker data were obtained; this was collected either after initial implant and follow-up or, for patients with previously placed devices, during a single encounter. The average monitoring period was 153 minutes. The study included 73 patients with normal sinus node function and varying degrees of AV block.While the number of patients with variable AV conduction was small (5), the investigators found that the rhythm checks allowed for appropriate mode adjustments during the study period. During periods of AV block, as expected, 99.9% ventricular pacing was observed while during 1:1 AV conduction only 0.2% pacing was observed. Ventricular pacing was monitored in patients with 1:1 AV conduction using conventional VVI pacing and MARVEL 2 programming. MARVEL 2 programming using the AV conduction mode switch algorithm resulted in a reduction in ventricular pacing from 22.8% to 0.2% (n=18). Reducing the burden of ventricular pacing is an important enhancement to the system with the potential to minimize pacing-induced cardiomyopathy.5One potential pitfall of atrial sensing addressed by this study is tracking of atrial arrhythmias. While the sample size was small (n=7), tracking of atrial fibrillation resulting in pacing at the upper tracking rate was not observed in any of the patients. In one patient with atrial flutter, intermittent atrial tracking did occur but did not result in tachycardia. In contrast to atrial rate based mode switching used in conventional dual-chamber pacemakers, the behavior of the MARVEL 2 algorithm during atrial fibrillation is dictated by the sensed ventricular rate. With the AV conduction mode switch enabled, if the ventricular rate is above 40 bpm, the pacing mode will be VVI at 40 bpm. If rates are less than 40 bpm, the pacing mode will be VDD. In the context of atrial fibrillation, reduced atrial contractility results in lack of mechanical sensing, and pacing at the lower rate is observed. In this small sample size, atrial arrhythmias did not result in device tracking resulting in tachycardia. Further investigation in a larger number of patients is warranted to better characterize these findings and to assess pacing behavior during more organized atrial arrhythmias which could result in mechanical sensing (atrial tachycardia and atrial flutter, for example).While the MARVEL 2 programming seems to perform well in the setting of atrial fibrillation or intermittent complete AV block, there are some potential pitfalls. AV conduction mode switch behavior is based on sensed ventricular rates with a threshold of 40 bpm; this cutoff is not currently programmable. Any ventricular sensed rhythm with a rate greater than 40 bpm will result in the device continuing at VVI 40. For example, in a patient with sinus rhythm at 90 bpm and 2:1 AV conduction, the device would not track the atrium and pace at 90 bpm, but rather remain VVI 40 because the ventricular sensed rate is above 40 bpm. The same would be observed in patients with junctional or ventricular escape rhythms >40 bpm. In this sense, pacing could be inappropriately inhibited during a potentially hemodynamically significant rhythm. For this reason, in our opinion, the AV conduction mode switch algorithm should be disabled in the majority of patients with AV block as this physiology is dynamic and sudden loss of rate support can have deleterious consequences. While the activity mode switch algorithm may address some of these concerns real world data are needed for validation.There is no question that the functionality and indications for leadless pacemakers will continue to expand. In current guidelines, which predate the development of the Micra AVTM, single chamber ventricular pacing is only recommended in patients with AV block and permanent atrial fibrillation, a low burden of anticipated pacing, or substantial comorbidities.6 Given the potential for lower complication rates compared with transvenous systems, Micra AV may be a superior option in some patients with complete heart block and preserved ventricular function. However, with the advent of conduction system pacing, the decreased risks of a leadless system have to be balanced with the relative risk of long term right ventricular pacing. Although the results will need to be validated with larger, longer-term studies, which are underway (Clinical trials.gov NCT04245345), these data indicate that Micra AVTM is likely to perform well in the setting of atrial arrhythmias. In patients with variable AV conduction, there are certainly pitfalls to the AV conduction mode switch algorithm, many of which could be avoided by the ability to program the mode switch VVI rate. While leadless pacing is often considered in patients with multiple comorbidities at high risk of complications from a transvenous system, we may be on the cusp of a dramatic paradigm shift. The technological developments and success of leadless pacing to date prompt the question of when, and not if, leadless dual chamber pacing and potentially even cardiac resynchronization will be available.References:1. Reynolds D, Duray GZ, Omar R, et al. A Leadless Intracardiac Transcatheter Pacing System. https://doi.org/10.1056/NEJMoa1511643. doi:10.1056/NEJMoa15116432. El-Chami MF, Al-Samadi F, Clementy N, et al. Updated performance of the Micra transcatheter pacemaker in the real-world setting: A comparison to the investigational study and a transvenous historical control. Heart Rhythm . 2018;15(12):1800-1807. doi:10.1016/j.hrthm.2018.08.0053. Duray GZ, Ritter P, El-Chami M, et al. Long-term performance of a transcatheter pacing system: 12-Month results from the Micra Transcatheter Pacing Study. Heart Rhythm . 2017;14(5):702-709. doi:10.1016/j.hrthm.2017.01.0354. Steinwender C, Khelae SK, Garweg C, et al. Atrioventricular Synchronous Pacing Using a Leadless Ventricular Pacemaker: Results From the MARVEL 2 Study. JACC Clin Electrophysiol . 2020;6(1):94-106. doi:10.1016/j.jacep.2019.10.0175. Merchant FM, Mittal S. Pacing induced cardiomyopathy. J Cardiovasc Electrophysiol . 2020;31(1):286-292. doi:10.1111/jce.142776. Kusumoto Fred M., Schoenfeld Mark H., Barrett Coletta, et al. 2018 ACC/AHA/HRS Guideline on the Evaluation and Management of Patients With Bradycardia and Cardiac Conduction Delay: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines and the Heart Rhythm Society. Circulation . 2019;140(8):e382-e482. doi:10.1161/CIR.0000000000000628
Reply to “Additional Data Protection of the Esophagus During Catheter Ablation of Atrial Fibrillation”Mahmoud Houmsse, MD, and Emile G. Daoud, MDDepartment of Medicine, Division of Cardiology, Richard M. Ross Heart HospitalThe Ohio State University Medical Center, Columbus, OHRunning Title: Protection of EsophagusAddress for correspondence: Emile Daoud, MDDHLRI 473 W. 12th Avenue, Suite 200 Columbus, OH 43210-1252 Telephone: 877-478-2478 FAX : 614-293-5614E-Mail: email@example.comFunding: NoneDisclosure: Emile Daoud and The Ohio State University have equity ownership and serve as consultants to S4 Medical Corp, which is manufacturing the Esoultion esophageal retractor.Disclosure: Mahmoud Houmsse has no conflict of interestWe Thank Dr.Clark and Dr. Kulstad for their interest in our recent review manuscript “protection of the esophagus during catheter ablation of atrial fibrillation”We agree with Dr. Clark and Dr. Kulstad that utilization of luminal esophageal temperature (LET) monitoring during atrial fibrillation ablation is inadequate method to avoid esophageal injury. These have been reported in multiple studies that were referenced in our manuscript. The newer published studies regrading monitoring LET during atrial fibrillation ablation, which were reported by Dr. Clark and Dr. Kulstad, have been published during our manuscript publication process. Nevertheless, these studies that reported by Dr. Clark and Dr. Kulstad showed same conclusion of inadequate LET monitoring in preventing esophageal injury 1-3.Regarding active cooling, Dr. Clark and Dr. Kulstad reported recent published studies. First study small pilot study that showed active cooling is much more protective than manual liquid instillation4. The second pilot RCT that compared LET and active cooling showed same outcome like the IMPACT study that we reported in our manuscript 5,6.We agree with Dr. Clark and Kulstad, growing interest in the area of esophageal protection during atrial fibrillation ablation.We do believe, as we stated in the conclusion of our manuscript, that “a reliable method to protect the esophagus is of clinical value, but the ancillary value of reducing physician concern during AF ablation, reducing interruption to ablation work flow, perhaps enhancing AF ablation results and simplifying post procedure management of patient symptoms are also of high importance. Considering the ease of use, minimal side effects, and low costs associated with esophageal protection devices, these features offer compelling evidence for use of esophageal protection as routine care for AF ablation”.
Despite being first described over 30 years ago, focal radiofrequency (RF) continues to be the most widely used energy modality for catheter ablation. The fact that it has managed to hold its own against stiff competition from alternative energy sources used for pulmonary vein isolation (PVI) is down to continuous evolution based on enhancements in our understanding of its biophysical principles. In particular, the advent of contact-force (CF) based integrated indices such as Ablation Index have improved both efficacy and safety. However, a significant limitation of this approach is the absence of tissue feedback during lesion creation, which results in a blunt ‘one-size-fits-all’ approach. This limitation has been further brought into focus by the recent appreciation of the much greater importance of circuit impedance rather than delivered power as a fundamental determinant of RF lesion size.
We have read with great interest the article “Efficacy of Catheter Ablation for Premature Ventricular Contractions (PVC) in Arrhythmogenic Right Ventricular Cardiomyopathy (ARVC)” by Assis F.R. et. al. PVC ablation in ARVC was previously studied by Aras D. et al and they presented successful results.In this study, we believe that the study should not be considered as unsuccessful since 2 patients showed a decrease in PVC burden by more than 80% and in the other three patients between 45-70%. The demonstration of a decrease in PVC burden with catheter ablation in ARVD patients indicates that a second ablation may increase the success rate and decrease symptoms. The fact that ARVC has a complex substrate and the disease can progress is undoubtedly the most important factor in achieving the desired success with PVC ablation. Epicardial ablation with endocardial ablation has increased the chance of success in this patient group. In addition, given that BCSD ablation and basal heart rate are guaranteed by ICD implantation, we think that administration of the maximum dose of antiarrhythmic medication may create a significant improvement in these patients. And another factor, contact force sensing plays an important role in evaluating the effectiveness of the process. We suggest that with the current treatment modalities, a pharmacoablative combination therapy and re-ablation when necessary would be appropriate for such a complicated disease.
Abstract Introduction: Linear ablation in addition to pulmonary vein antrum isolation (PVAI) has failed to improve the success rate for persistent atrial fibrillation (PeAF), due to incomplete block of ablation lines, especially in the mitral isthmus (MI). Methods and results: The study enrolled 191 patients (66 in group 1 and 125 in group 2). In group 1, EI-VOM was firstly performed, followed by radiofrequency (RF) applications targeting bilateral PVAI and bidirectional block in the roofline, cavotricuspid isthmus, and MI. In group 2, PVAI and the three linear ablations were completed using only RF energy. MI block was achieved in 63(95.5%) and 101(80.8%) patients in group 1 and 2, respectively (p=0.006). Patients in group 1 had shorter ablation time for left pulmonary vein antrum (8.15 min vs 12.59 min, p<0.001) and MI (7.0 min vs 11.8 min, p<0.001) and required less cardioversion (50(78.5%) vs 113(90.4%), p=0.007). During the 12-month follow-up, 58 (87.9%) patients were free from AF/AT in group 1 compared with 81 (64.8%) in group 2 (p<0.001). In multivariate cox regression, the ‘upgraded 2C3L’ procedure is associated with a lower recurrence rate (HR 0.27, 95%CI 0.12-0.59). Conclusion: Compared with the conventional ‘2C3L’ approach, the ‘upgraded 2C3L’ approach has higher effectiveness for ablation of PeAF.
Background: Transvenous implantable cardiac defibrillators (TV ICD) provide life-saving therapy for millions of patients worldwide. However, they are susceptible to several potential short- and long- term complications including cardiac perforation and pneumothorax, lead dislodgement, venous obstruction, and infection. The extravascular ICD (EV ICD) system’s novel design and substernal implant approach avoids the risks associated with TV ICDs while still providing pacing features and similar generator size to TV ICDs. Study Design: The EV ICD pivotal study is a prospective, multi-center, single-arm, non-randomized, pre-market clinical study designed to examine the safety and acute efficacy of the system. This study will enroll up to 400 patients with a Class I or IIa indication for implantation of an ICD. Implanted subjects will be followed up to approximately 3.5 years, depending on when the patient is enrolled. Objective: The clinical trial is designed to demonstrate safety and effectiveness of the EV ICD system in human use. The safety endpoint is freedom from major complications, while the efficacy endpoint is defibrillation success. Both endpoints will be assessed against prespecified criteria. Additionally, this study will evaluate antitachycardia pacing (ATP) performance, electrical performance, extracardiac pacing sensation, asystole pacing, appropriate and inappropriate shocks, as well as a summary of adverse events. Conclusion: The EV ICD pivotal study is designed to provide clear evidence addressing the safety and efficacy performance of the EV ICD System.
Background Charge density mapping of atrial fibrillation (AF) reveals dynamic patterns of localised rotational activation (LRA), irregular activation (LIA) and focal firing (FF). Their spatial stability, conduction characteristics and the optimal duration of mapping required to reveal these phenomena and has not been explored. Methods Bi-atrial mapping of AF propagation was undertaken and variability of activation patterns quantified up to a duration of 30-seconds(s). The frequency of each pattern was quantified at each vertex of the chamber over 2 separate 30s recordings prior to ablation and R2 calculated to quantify spatial stability. Regions with the highest frequency were identified at increasing time durations and compared to the result over 30s using Cohen’s kappa. Properties of regions with the most stable patterns were assessed during sinus rhythm and extrastimulus pacing. Results In twenty-one patients, 62 paired LA and RA maps were obtained. LIA was highly spatially stable with R2 between maps of 0.83(0.71-0.88) compared to 0.39(0.24-0.57) and 0.64(0.54-0.73) for LRA and FF, respectively. LIA was also most temporally stable with a kappa of >0.8 reached by 12s. LRA showed greatest variability with kappa>0.8 only after 22s. Regions of LIA were of normal voltage amplitude (1.09mv) but showed increased conduction heterogeneity during extrastimulus pacing (p=0.0480). Conclusion Irregular activation patterns characterised by changing wavefront direction are temporally and spatially stable in contrast with rotational patterns that are transient with least spatial stability. Focal activation appears of intermediate stability. Regions of LIA show increased heterogeneity following extrastimulus pacing and may represent fixed anatomical substrate.
Background: It is established that ethanol infusion in the vein of Marshall (EIVOM) effectively creates a linear ablation lesion in the mitral isthmus (MI). However, data on the long-term success rates of MI ablation remains limited. Methods and Results: Our cohort consisted of 560 patients with non-paroxysmal atrial fibrillation (AF) who underwent an initial MI ablation. Ablations were performed by only radiofrequency (RF) in 384 patients (RF group) or by RF and EIVOM in 176 patients (EIVOM/RF group). Ethanol of 5 mL was used to perform EIVOM in advance of RF. Following EIVOM, RF pulses were delivered to the lateral MI line. Bidirectional MI block was fully achieved in 353 (first 318, re-do 35) patients of the RF group and 171 (first 128, re-do 43) patients of the EIVOM/RF group (p = 0.09 in the first, 0.10 in the re-do ablation cases). In cases with complete MI line block, recurrent AF or atrial tachycardia (AT) was observed in 130 (37%) patients of the RF group and in 64 (37%) patients of the EIVOM/RF group (log-rank p = 0.12 in the first, 0.30 in the re-do ablation cases). Of the total 194 patients, 112 with drug refractory AF or AT proceeded to the subsequent ablation process. Reconnection of MI block line was observed in 39 (49%) patients in the RF group and 25 (58%) patients in the EIVOM/RF group (p = 0.32). Conclusion: EIVOM effectively ensures MI line block; however, the reconnection rate was similar between the two groups.
The excellent review by Houmsse and Daoud of techniques and methods utilized to protect the esophagus from injury during atrial fibrillation (AF) ablation appropriately concludes that considering the ease of use, minimal side effects, and low costs associated with esophageal protection devices, compelling evidence exists for use of esophageal protection as routine care for AF ablation. Some additional data are available which would warrant inclusion in further consideration of this topic. Three recent studies have demonstrated the inability of LET monitoring to protect the esophagus, whereas meta-analysis of three studies of manual cooling using direct liquid instillation suggests that this approach significantly reduced high-grade lesion formation (OR of 0.39, 95% CI 0.17 to 0.89). Moreover, three studies using a commercially available cooling device FDA cleared for thermal regulation have shown reductions in esophageal lesion severity without degradation in ablation efficacy.