A leadless ventricular pacemaker providing atrioventricular synchronous pacing in the real-world setting: 12-Month results from the Micra AV post-approval registry.

BACKGROUND: Advances in leadless pacemaker technology have enabled accelerometer-based atrioventricular (AV) synchronous pacing by sensing atrial mechanical contraction. OBJECTIVE: The purpose of this study was to report the performance of the Micra AV leadless pacemaker from the worldwide Micra AV post-approval registry (PAR) through 12 months. METHODS: The Micra AV PAR is a prospective, single-arm, observational registry designed to assess the safety and effectiveness of Micra AV in a real-world setting. For the present interim analysis, major complications and system revisions through 12 months were summarized and compared to a historical cohort of 2667 transvenous dual-chamber pacing patients. RESULTS: The device was successfully implanted in 796 of 801 patients (99.4%) at 97 centers in 19 countries. Micra AV patients were older (74.1 years vs 71.1 years; P < .0001) with a higher incidence of renal disease (22.3% vs 9.8%; P < .0001) compared with transvenous dual-chamber patients. Through 12 months, the major complication rate was 3.7% in Micra AV patients compared with 8.8% in transvenous dual-chamber patients (hazard ratio 0.42; 95% confidence interval 0.28-0.61; P < .001). The system revision rate was 1.5% in Micra AV patients compared with 5.5% for transvenous dual-chamber patients (hazard ratio 0.25; 95% confidence interval 0.13-0.47; P < .001); this reduction was largely driven by the absence of lead dislodgments requiring revision. The median AV synchrony index was 79.4% (interquartile range 65.2%-86.4%) in patients paced >90%. CONCLUSION: The Micra AV leadless pacemaker was implanted with a high rate of success in patients with multiple comorbidities, with a significantly lower rate of complications and system revisions through 12 months compared to a historical cohort of patients with transvenous dual-chamber pacemakers.

Global LEADR pivotal trial results.

BACKGROUND: Implantable cardioverter-defibrillators last longer, and interest in reliable leads with targeted lead placement is growing. The OmniaSecure™ defibrillation lead is a novel small-diameter, catheter-delivered lead designed for targeted placement, based on the established SelectSecure SureScan MRI Model 3830 lumenless pacing lead platform. OBJECTIVE: This trial assessed safety and efficacy of the OmniaSecure defibrillation lead. METHODS: The worldwide LEADR pivotal clinical trial enrolled patients indicated for de novo implantation of a primary or secondary prevention implantable cardioverter-defibrillator/cardiac resynchronization therapy defibrillator, all of whom received the study lead. The primary efficacy end point was successful defibrillation at implantation per protocol. The primary safety end point was freedom from study lead-related major complications at 6 months. The primary efficacy and safety objectives were met if the lower bound of the 2-sided 95% credible interval was >88% and >90%, respectively. RESULTS: In total, 643 patients successfully received the study lead, and 505 patients have completed 12-month follow-up. The lead was placed in the desired right ventricular location in 99.5% of patients. Defibrillation testing at implantation was completed in 119 patients, with success in 97.5%. The Kaplan-Meier estimated freedom from study lead-related major complications was 97.1% at 6 and 12 months. The trial exceeded the primary efficacy and safety objective thresholds. There were zero study lead fractures and electrical performance was stable throughout the mean follow-up of 12.7 ± 4.8 months (mean ± SD). CONCLUSION: The OmniaSecure lead exceeded prespecified primary end point performance goals for safety and efficacy, demonstrating high defibrillation success and a low occurrence of lead-related major complications with zero lead fractures.

The utility and impact of outpatient telemetry monitoring in post-transcatheter aortic valve replacement patients.

BACKGROUND: Conduction disturbances are a common complication of transcatheter aortic valve replacement (TAVR). Mobile Cardiac Telemetry (MCT) allows for continuous monitoring with near "real time" alerts and has allowed for timely detection of conduction abnormalities and pacemaker placement in small trials. A standardized, systematic approach utilizing MCT devices post TAVR has not been widely implemented, leading to variation in use across hospital systems. OBJECTIVES: Our aim was to evaluate the utility of a standardized, systematic approach utilizing routine MCT to facilitate safe and earlier discharge by identifying conduction disturbances requiring permanent pacemaker (PPM) placement. We also sought to assess the occurrence of actionable arrhythmias in post-TAVR patients. METHODS: Using guidance from the JACC Scientific Expert Panel, a protocol was implemented starting in December 2019 to guide PPM placement post-TAVR across our health system. All patients who underwent TAVR from December 2019 to June 2021 across four hospitals within Northwell Health, who did not receive or have a pre-existing PPM received an MCT device at discharge and were monitored for 30 days. Clinical and follow-up data were collected and compared to pre initiative patients. RESULTS: During the initiative 693 patients were monitored with MCT upon discharge, 21 of whom required PPM placement. Eight of these patients had no conduction abnormality on initial or discharge ECG. 59 (8.6 %) patients were found to have new atrial fibrillation or flutter via MCT monitoring. There were no adverse events in the initiative group. Prior to the initiative, 1281 patients underwent TAVR over a one-year period. The initiative group had significantly shorter length of stay than pre-initiative patients (2.5 ± 4.5 vs 3.0 ± 3.8 days, p < 0.001) and lower overall PPM placement rate within 30 days post-TAVR (16 % vs 20.5 %, P = 0.0125). CONCLUSIONS: In our study, implementation of a standardized, systematic approach utilizing MCT in post-TAVR patients was safe and allowed for timely detection of conduction abnormalities requiring pacemaker placement. This strategy also detected new atrial fibrillation and flutter. Reduction in post TAVR pacemaker rate and length of stay were also noted although this effect is multifactorial.

Implantation of cardiac electronic devices in active COVID-19 patients: Results from an international survey.

BACKGROUND: Cardiac implantable electronic device (CIED) implantation rates as well as the clinical and procedural characteristics and outcomes in patients with known active coronavirus disease 2019 (COVID-19) are unknown. OBJECTIVE: The purpose of this study was to gather information regarding CIED procedures during active COVID-19, performed with personal protective equipment, based on an international survey. METHODS: Fifty-three centers from 13 countries across 4 continents provided information on 166 patients with known active COVID-19 who underwent a CIED procedure. RESULTS: The CIED procedure rate in 133,655 hospitalized COVID-19 patients ranged from 0 to 16.2 per 1000 patients (P <.001). Most devices were implanted due to high-degree/complete atrioventricular block (112 [67.5%]) or sick sinus syndrome (31 [18.7%]). Of the 166 patients in the study survey, the 30-day complication rate was 13.9% and the 180-day mortality rate was 9.6%. One patient had a fatal outcome as a direct result of the procedure. Differences in patient and procedural characteristics and outcomes were found between Europe and North America. An older population (76.6 vs 66 years; P <.001) with a nonsignificant higher complication rate (16.5% vs 7.7%; P = .2) was observed in Europe vs North America, whereas higher rates of critically ill patients (33.3% vs 3.3%; P <.001) and mortality (26.9% vs 5%; P = .002) were observed in North America vs Europe. CONCLUSION: CIED procedure rates during known active COVID-19 disease varied greatly, from 0 to 16.2 per 1000 hospitalized COVID-19 patients worldwide. Patients with active COVID-19 infection who underwent CIED implantation had high complication and mortality rates. Operators should take these risks into consideration before proceeding with CIED implantation in active COVID-19 patients.

Limitation of standard ECG criteria to localize an outflow tract PVC.

Multiple ECG algorithms exist to localize outflow tract PVCs. They can be invaluable in pre-procedure planning and patient counseling. We describe a case where the published algorithm for PVC localization did not predict the site of origin and successful ablation site. This case highlights the strengths and limitations of established ECG PVC localization algorithms.

Use of a Smartwatch for Assessment of the QT Interval in Outpatients with Coronavirus Disease 2019.

The coronavirus disease 2019 (COVID-19) pandemic has necessitated rapid implementation of innovative strategies to manage patients remotely to help reduce the risk of community and nosocomial transmission. This case demonstrates the use of an Apple Watch (Apple, Cupertino, CA, USA) to monitor for arrhythmias and QT prolongation in a patient with COVID-19 during home isolation.

Bradyarrhythmias in patients with COVID-19: Marker of poor prognosis?

BACKGROUND: Despite descriptions of various cardiovascular manifestations in patients with coronavirus disease 2019 (COVID-19), there is a paucity of reports of new onset bradyarrhythmias, and the clinical implications of these events are unknown. METHODS: Seven patients presented with or developed severe bradyarrhythmias requiring pacing support during the course of their COVID-19 illness over a 6-week period of peak COVID-19 incidence. A retrospective review of their presentations and clinical course was performed. RESULTS: Symptomatic high-degree heart block was present on initial presentation in three of seven patients (43%), and four patients developed sinus arrest or paroxysmal high-degree atrioventricular block. No patients in this series demonstrated left ventricular systolic dysfunction or acute cardiac injury, whereas all patients had elevated inflammatory markers. In some patients, bradyarrhythmias occurred prior to the onset of respiratory symptoms. Death from complications of COVID-19 infection occurred in 57% (4/7) patients during the initial hospitalization and in 71% (5/7) patients within 3 months of presentation. CONCLUSIONS: Despite management of bradycardia with temporary (3/7) or permanent leadless pacemakers (4/7), there was a high rate of short-term morbidity and death due to complications of COVID-19. The association between new-onset bradyarrhythmias and poor outcomes may influence management strategies for acutely ill patients with COVID-19.

Arrhythmias from the Right Ventricular Moderator Band: Diagnosis and Management.

The moderator band in the right ventricle is being increasingly recognised as a source for arrhythmias in the absence of identifiable structural heart disease. Because it carries part of the conduction system from the right ventricle septum to the free wall, it is a source of Purkinje-mediated ventricular arrhythmias that manifest as premature ventricular contractions (PVC) or repetitive ventricular tachycardia. More importantly, short coupled PVCs triggering polymorphic ventricular tachycardia and VF have been localised to the moderator band and ablation of these Purkinje mediated PVCs can effectively prevent recurrent VF. The exact mechanism of arrhythmogenesis is still debated but stretch, fibrosis and ion channel alterations might be responsible. Arrhythmias originating in this region of the right ventricle may thus be another cause for idiopathic VF that is potentially treatable with catheter-based ablation techniques. Recognition of the typical PVC morphology can point to the moderator band as the source of idiopathic VF and an opportunity for timely intervention. The available data on the anatomy, electrophysiology and management options are reviewed.

Effect of Chloroquine, Hydroxychloroquine, and Azithromycin on the Corrected QT Interval in Patients With SARS-CoV-2 Infection.

BACKGROUND: The novel SARS-CoV-2 (severe acute respiratory syndrome coronavirus 2) is responsible for the global coronavirus disease 2019 pandemic. Small studies have shown a potential benefit of chloroquine/hydroxychloroquine±azithromycin for the treatment of coronavirus disease 2019. Use of these medications alone, or in combination, can lead to a prolongation of the QT interval, possibly increasing the risk of Torsade de pointes and sudden cardiac death. METHODS: Hospitalized patients treated with chloroquine/hydroxychloroquine±azithromycin from March 1 to the 23 at 3 hospitals within the Northwell Health system were included in this prospective, observational study. Serial assessments of the QT interval were performed. The primary outcome was QT prolongation resulting in Torsade de pointes. Secondary outcomes included QT prolongation, the need to prematurely discontinue any of the medications due to QT prolongation, and arrhythmogenic death. RESULTS: Two hundred one patients were treated for coronavirus disease 2019 with chloroquine/hydroxychloroquine. Ten patients (5.0%) received chloroquine, 191 (95.0%) received hydroxychloroquine, and 119 (59.2%) also received azithromycin. The primary outcome of torsade de pointes was not observed in the entire population. Baseline corrected QT interval intervals did not differ between patients treated with chloroquine/hydroxychloroquine (monotherapy group) versus those treated with combination group (chloroquine/hydroxychloroquine and azithromycin; 440.6±24.9 versus 439.9±24.7 ms, P=0.834). The maximum corrected QT interval during treatment was significantly longer in the combination group versus the monotherapy group (470.4±45.0 ms versus 453.3±37.0 ms, P=0.004). Seven patients (3.5%) required discontinuation of these medications due to corrected QT interval prolongation. No arrhythmogenic deaths were reported. CONCLUSIONS: In the largest reported cohort of coronavirus disease 2019 patients to date treated with chloroquine/hydroxychloroquine±azithromycin, no instances of Torsade de pointes, or arrhythmogenic death were reported. Although use of these medications resulted in QT prolongation, clinicians seldomly needed to discontinue therapy. Further study of the need for QT interval monitoring is needed before final recommendations can be made.

Early recurrence of atrial fibrillation after pulmonary vein isolation: a comparative analysis between cryogenic and contact force radiofrequency ablation.

BACKGROUND: Early recurrence (ER) of atrial fibrillation (AF) within 90 days post-ablation is observed in up to 50% of patients and has been attributed to transient inflammation. The importance of ER in current era of pulmonary vein isolation (PVI) with cryoballoon ablation (CBA) and contact-force catheter radiofrequency ablation (cfRFA) has not been clearly reported. In addition, it is not known whether there are differences between types of ablation energy used during PVI. METHODS: Study population was drawn from a prospective multicenter database of AF ablation. Consecutive patients undergoing first-time ablation with PVI alone, using either second-generation CBA or cfRFA catheters were included. Patients were followed at 0.5, 3, 6, and 12 months to assess recurrence. Predictors of late recurrence (LR), defined as recurrence outside the blanking period, were assessed by Cox proportional hazards regression models. Freedom from LR was calculated and compared between two groups using the Kaplan-Meier method and log-rank test. RESULTS: Study cohort included 300 patients (1:1 CBA:RFA, age 63.6 ± 10.3 years, 67% male). There were no baseline characteristic differences between the CBA and cfRFA groups. ER occurred in 23.3% and 16.7% of patients in the CBA and cfRFA groups, respectively (p = 0.149). One-year freedom from LR was similar for both groups (72.7% CBA vs. 78% cfRFA, p = 0.287). Fifty-two patients (25 CBA and 27 cfRFA) underwent repeat ablation and no difference in durability of PVI was found. ER was the only common independent predictor of LR for either group and for the entire cohort (HR 2.3). CONCLUSIONS: In our series of AF ablation using second-generation cryoballoon and contact-force RFA catheters, recurrence in the "blanking period" is seen in 20% and remains predictive of late recurrence irrespective of the energy used.

Downstream overdrive pacing and intracardiac concealed fusion to guide rapid identification of atrial tachycardia after atrial fibrillation ablation.

Aims: Atrial tachycardia (AT) related to atrial fibrillation (AF) ablation frequently poses a diagnostic challenge. Downstream overdrive pacing (DOP) can be used to rapidly detect reentry and assess proximity of a pacing site to an AT circuit or focus. We hypothesized that systematic DOP using multielectrode catheters would facilitate AT mapping. Methods and results: DOP identified constant fusion when the post-pacing interval (PPI)-tachycardia cycle length (TCL) <40 ms and stimulus to adjacent upstream atrial electrogram interval >75% of TCL. Mapping was performed as follows: (i) CS DOP, (ii) DOP at left atrial (LA) roof, (iii) DOP at selected LA sites based on prior DOP attempts, and (iv) mapping and ablation at regions of fractionated electrograms in region of AT. Activation mapping was performed at operator discretion. AT diagnosis was confirmed by successful ablation or additional mapping when ablation was unsuccessful. Fifty consecutive patients with sustained AT underwent mapping of 68 ATs, of whom 42 (62%) were macroreentrant, 19 were locally reentrant (28%), and 7 (10%) were focal. AT was correctly identified with a median of three DOP attempts. All macroreentrant ATs were identified with ≤6 DOP attempts. One AT (1.6%) was terminated by DOP, and three ATs (4.8%) required activation mapping. Intracardiac concealed fusion was seen in 26 ATs (38%), each of which was successfully ablated. Conclusion: Reentry could be demonstrated in a substantial majority of AF ablation-related AT. A stepwise diagnostic approach using DOP and recognition of intracardiac concealed fusion can be used to rapidly identify and ablate reentrant AT.

Determinants of Heparin Dosing and Complications in Patients Undergoing Left Atrial Ablation on Uninterrupted Rivaroxaban.

BACKGROUND: Patients on rivaroxaban have variable international normalized ratios (INRs) but it is uncertain if INR impacts procedural heparin requirement during left atrial ablation. We sought to examine the determinants of heparin dosing in this patient population. METHODS: We reviewed consecutive patients who received rivaroxaban within 24 hours of left atrial ablation and compared them to patients on uninterrupted warfarin. The determinants of heparin requirement were evaluated using regression analysis. We then tested a weight-based heparin dose prospectively in rivaroxaban patients. RESULTS: There were 258 patients on rivaroxaban and 213 on warfarin. The mean INR was 1.4 in the rivaroxaban group and 2.3 in the warfarin group (P < 0.01). To achieve an activated clotting time (ACT) >350 seconds, rivaroxaban patients required significantly more heparin (166.9 vs. 78.3 units/kg, P < 0.001). In the rivaroxaban group, body weight was the strongest predictor of heparin dose (r = 0.52), while INR was weakly correlated (r = -0.21). In the prospective group, 25 patients were given an initial heparin dose of 120 units/kg with 22/25 (88%) achieving an ACT > 300 seconds. There were seven and three cases of pericardial effusion in rivaroxaban and warfarin patients, respectively (P = 0.41). The average volume drained in the rivaroxaban group was elevated (988.6 vs. 275.0 mL, P = 0.21). CONCLUSIONS: Body weight is the strongest predictor of procedural heparin requirement during left atrial ablation in patients on uninterrupted rivaroxaban, even in those with an elevated INR. A heparin dose of 120 units/kg achieves an ACT > 300 seconds in the majority of patients. In cases of pericardial effusion, bleeding may be prolonged.

Impedance-guided Radiofrequency Ablation: Using Impedance to Improve Ablation Outcomes.

Despite the achievement of acute conduction block during catheter ablation, the recovery of conduction at previously ablated sites remains a primary factor implicated in arrhythmia recurrence after initial ablation. Real-time markers of adequate ablation lesion creation are needed to ensure durable ablation success. However, the assessment of acute lesion formation is challenging, and requires interpretation of surrogate markers of lesion creation that are frequently unreliable. Careful monitoring of impedance changes during radiofrequency catheter ablation has emerged as a highly specific marker of local tissue destruction. Ablation strategies guided by close impedance monitoring during ablation applications have been demonstrated to achieve high levels of success for ablation of atrial fibrillation. Impedance decrease during ablation may therefore be used as an additional endpoint beyond acute conduction block, in order to improve the durability of ablation lesions. In this manuscript, available methods of real-time lesion assessment are reviewed, and the rationale and technique for impedance-guided ablation are described.

Selective His-bundle Pacing May Preserve Intrinsic Repolarization as Well as Depolarization.

A 79-year-old man with chronic atrial fibrillation underwent single-chamber His-bundle pacemaker implantation. The post-implant electrocardiogram (ECG) demonstrated selective His-bundle capture, with a narrow paced QRS and repolarization pattern similar to that of the baseline ECG. Furthermore, repolarization changes prototypic of ventricular pacing did not occur with selective His-bundle capture. While His-bundle pacing, with or without selective His-bundle capture, can preserve physiologic patterns of depolarization, only His-bundle selective pacing can preserve intrinsic ST- and T-wave patterns. Thus, the maintenance of physiologic repolarization may have various advantages, including accurate interpretation of ECG changes that are not generally interpretable in the setting of ventricular pacing.

Sites With Small Impedance Decrease During Catheter Ablation for Atrial Fibrillation Are Associated With Recovery of Pulmonary Vein Conduction.

OBJECTIVE: To correlate impedance decrease during atrial fibrillation (AF) ablation with lesion durability and PV conduction recovery demonstrated during redo procedures. BACKGROUND: Markers of successful ablation beyond acute conduction block are needed to improve durability of pulmonary vein (PV) isolation (PVI). Local impedance decrease resulting from ablation is a real-time marker of tissue heating and is correlated with lesion creation. METHODS: Impedance changes associated with point-by-point radiofrequency ablation in the PV antra were recorded during 167 consecutive first-time AF ablations. During clinically indicated redo procedures, sites of recovered PV conduction were identified, and were correlated with the impedance change achieved during ablation at these locations during the initial procedure. RESULTS: Redo procedures were performed in 28 patients, in whom 19 sites of recovered PV conduction were documented. Most sites of PV reconnection (58%) occurred along the posterior PV antra. Ablation resulting in impedance decrease <10 ohms during the initial procedure was present in 89% (17/19) of sites with conduction recovery. Regions with adjacent ablation resulting in impedance decrease <10 ohms were associated with a higher rate of conduction recovery (37% vs. 1.5%, P < 0.001). Likewise, patients with PV conduction recovery demonstrated during redo procedure (Group 1) had larger regions where ablation resulted in <10 ohm impedance decrease than patients without PV conduction recovery (Group 2) (21.9 ± 15.5 mm vs. 11.5 ± 2.1 mm, P < 0.01). CONCLUSION: Recovered PV conduction occurs predominantly in regions where adjacent ablation applications result in impedance decreases <10 ohms. Impedance-guided ablation strategies may improve durability of PVI.

Recurrence of Atrial Arrhythmias Despite Persistent Pulmonary Vein Isolation After Catheter Ablation for Atrial Fibrillation: A Case Series.

OBJECTIVES: The aim of this study was to categorize arrhythmia mechanisms and to summarize ablation strategies in patients with persistent pulmonary vein isolation (PVI) at the time of redo procedures. BACKGROUND: Persistent PVI is more frequently seen in patients undergoing redo procedures for recurrent atrial arrhythmias after catheter ablation for atrial fibrillation (AF). METHODS: Consecutive patients who underwent their first AF ablation procedures at Brigham and Women's Hospital were screened and included if they had persistent isolation of all pulmonary veins at the time of redo procedures. RESULTS: Of 300 consecutive patients undergoing first AF ablation procedures, redo procedures were performed in 63 (21%), and 26 patients (9%) had persistent PVI. Of those, 11 had recurred with AF and 15 with organized atrial tachycardia (AT). During the index procedure, linear ablation was performed in 46% of patients with recurrent AF and 93% with recurrent organized AT (p = 0.020). At the time of last follow-up, 2 of 10 patients (20%) in the AF group and 10 of 15 patients (67%) in AT group were in sinus rhythm, without class I or III antiarrhythmic drugs (p = 0.022). CONCLUSIONS: Patients with recurrence of atrial arrhythmia despite persistent PVI frequently present with organized AT. Linear ablation during the index procedure is associated with recurrence of organized AT. Recurrence rates after redo procedures were higher if patients had recurrent AF after the index procedure, and these patients often presented with AF again. Patients with recurrent AF despite persistent PVI may represent a population with lower success rates of catheter ablation.

Better outcome of ablation for sustained outflow-tract ventricular tachycardia when tachycardia is inducible.

AIMS: In patients presenting with spontaneous sustained ventricular tachycardia (VT) from the outflow-tract region without overt structural heart disease ablation may target premature ventricular contractions (PVCs) when VT is not inducible. We aimed to determine whether inducibility of VT affects ablation outcome. METHODS AND RESULTS: Data from 54 patients (31 men; age, 52 ± 13 years) without overt structural heart disease who underwent catheter ablation for symptomatic sustained VT originating from the right- or left-ventricular outflow region, including the great vessels. A single morphology of sustained VT was inducible in 18 (33%, SM group) patients, and 11 (20%) had multiple VT morphologies (MM group). VT was not inducible in 25 (46%) patients (VTni group). After ablation, VT was inducible in none of the SM group and in two (17%) patients in the MM group. In the VTni group, ablation targeted PVCs and 12 (48%) patients had some remaining PVCs after ablation. During follow-up (21 ± 19 months), VT recurred in 46% of VTni group, 40% of MM inducible group, and 6% of the SM inducible group (P = 0.004). Analysis of PVC morphology in the VTi group further supported the limitations of targeting PVCs in this population. CONCLUSION: Absence of inducible VT and multiple VT morphologies are not uncommon in patients with documented sustained outflow-tract VT without overt structural heart disease. Inducible VT is associated with better outcomes, suggesting that attempts to induce VT to guide ablation are important in this population.