A Dual-Chamber Leadless Pacemaker.

BACKGROUND: Single-chamber ventricular leadless pacemakers do not support atrial pacing or consistent atrioventricular synchrony. A dual-chamber leadless pacemaker system consisting of two devices implanted percutaneously, one in the right atrium and one in the right ventricle, would make leadless pacemaker therapy a treatment option for a wider range of indications. METHODS: We conducted a prospective, multicenter, single-group study to evaluate the safety and performance of a dual-chamber leadless pacemaker system. Patients with a conventional indication for dual-chamber pacing were eligible for participation. The primary safety end point was freedom from complications (i.e., device- or procedure-related serious adverse events) at 90 days. The first primary performance end point was a combination of adequate atrial capture threshold and sensing amplitude at 3 months. The second primary performance end point was at least 70% atrioventricular synchrony at 3 months while the patient was sitting. RESULTS: Among the 300 patients enrolled, 190 (63.3%) had sinus-node dysfunction and 100 (33.3%) had atrioventricular block as the primary pacing indication. The implantation procedure was successful (i.e., two functioning leadless pacemakers were implanted and had established implant-to-implant communication) in 295 patients (98.3%). A total of 35 device- or procedure-related serious adverse events occurred in 29 patients. The primary safety end point was met in 271 patients (90.3%; 95% confidence interval [CI], 87.0 to 93.7), which exceeded the performance goal of 78% (P<0.001). The first primary performance end point was met in 90.2% of the patients (95% CI, 86.8 to 93.6), which exceeded the performance goal of 82.5% (P<0.001). The mean (±SD) atrial capture threshold was 0.82±0.70 V, and the mean P-wave amplitude was 3.58±1.88 mV. Of the 21 patients (7%) with a P-wave amplitude of less than 1.0 mV, none required device revision for inadequate sensing. At least 70% atrioventricular synchrony was achieved in 97.3% of the patients (95% CI, 95.4 to 99.3), which exceeded the performance goal of 83% (P<0.001). CONCLUSIONS: The dual-chamber leadless pacemaker system met the primary safety end point and provided atrial pacing and reliable atrioventricular synchrony for 3 months after implantation. (Funded by Abbott Medical; Aveir DR i2i ClinicalTrials.gov number, NCT05252702.).

Leadless cardiac ventricular pacing using helix fixation: Step-by-step guide to implantation.

INTRODUCTION: Leadless cardiac pacemakers are an alternative modality to traditional transvenous pacemaker systems. Recently receiving Food and Drug Administration approval, the AVEIR VR leadless pacemaker system provides a helix based active fixation leadless pacemaker system. This step-by-step review will cover patient selection, preprocedural planning, device implantation technique, implant site evaluation, troubleshooting, short- and long-term complications as well as future directions for leadless pacing. METHODS: We collected and reviewed cases from primary operators to provide a step-by-step review for implanters. RESULTS: Our paper provides a guide to patient selection, pre-procedural planning, device im plantation technique, implant site evaluation, troubleshooting, short- and long-term complications as well as future directions for leadless pacing. CONCLUSION: The helix based active fixation leadless pacemaker system is a safe and efficacious way to provide pacing support to patients and provides an alternative to transvenous pacing systems. Our review provides a step-by-step guide to implantation.

Impact of redo ablation for atrial fibrillation on patient-reported outcomes and quality of life.

INTRODUCTION: Catheter ablation for atrial fibrillation (AF) is frequently used for the purpose of rhythm control and improved quality of life (QoL). Although success rates are high, a significant proportion of patients require redo ablation. Data are scarce on patient-centered outcomes and QoL in patients undergoing redo AF ablation. We aimed to assess QoL and clinical outcomes using a large prospectively maintained patient-reported outcomes (PRO) registry. METHODS: All patients undergoing redo AF ablation (2013-2016) at our center were enrolled in a prospective registry for outcomes and assessed for QoL using automated PRO surveys (baseline, 3 and 6 months after ablation, every 6 months thereafter). Data were collected over 3 years of follow-up. The atrial fibrillation symptom severity scale (AFSSS) was used as the main measure for QoL. Additional variables included patient-reported improvement, AF burden, and AF-related healthcare utilization including emergency room (ER) visits and hospitalizations. RESULTS: A total of 848 patients were included (28% females, mean age 63.8, 51% persistent AF). By automated PRO, significant improvement in QoL was noted (baseline median AFSSS of 12 [5-18] and ranged between 2 and 4 on subsequent assessments; p < .0001), with ≥70%of patients reported remarkable improvement in their AF-related symptoms. The proportion of patients in AF at the time of baseline survey was 36%, and this decreased to <8% across all time points during follow-up (p < .0001). AF burden was significantly reduced (including frequency and duration of episodes; p < .0001), with an associated decrease in healthcare utilization after 6 months from the time of ablation (including ER visits and hospitalizations; p < .0001). The proportion of patients on anticoagulants or antiarrhythmics decreased on follow-up across all time points (p < .0001 for all variables). CONCLUSION: Most patients derive significant QoL benefit from redo AF ablation; with reduction of both AF burden and healthcare utilization.

Outcomes of atrial fibrillation ablation in patients with or without silent pulmonary veins from prior ablation procedure.

INTRODUCTION: Pulmonary venous (PV) electrical recovery underlies most arrhythmia recurrences after atrial fibrillation (AF) ablation. Little is known about procedural profiles and outcomes of patients with electrically silent PVs upon redo ablation for AF. METHODS: In a prospectively maintained registry, we enrolled 838 consecutive patients (2013-2016) undergoing redo ablation procedures. Ablation procedures targeted the PVs, the PV antra, and non-PV sites at operators' discretion. Procedural profiles and clinical outcomes were assessed. The primary outcome was freedom from AF after a 3-month blanking period. The secondary outcome was improvement in quality of life. RESULTS: Most patients undergoing redo AF ablation (n = 684, 82%) had PV reconnection while the remaining 154 (18%) had electrically silent PVs. Patients with recurrent AF and electrically silent PVs were older (66 vs. 64 years, p = .02), had more prior ablation procedures (median 2 IQR 1-3 vs 1 IQR 1-2 p = .001), were more likely to have non-paroxysmal AF (62% vs. 49%, p = .004) and atrial flutter (48% vs. 29%, p = .001) and had significantly larger left atrial volumes (89 vs. 81 ml, p = .003). Patients with silent PVs underwent a more extensive non-PV ablation strategies with antral extension of prior ablation sets in addition to ablation of the roof, appendage, inferior to the right PVs, peri-mitral flutter lines, cavotricuspid isthmus lines and ablation in the coronary sinus. Upon one year of follow-up, patients with electrically silent PVs were less likely to remain free from recurrent atrial arrhythmias (64% vs. 76%, p = .008). Regardless of PV reconnection status, redo ablation resulted in improvement in quality of life. CONCLUSION: Rhythm control with extensive ablation allowed maintenance of sinus rhythm in about two thirds of patients with silent PVs during redo AF ablation procedures. Regardless of PV reconnection status, redo ablation resulted in improvement in quality of life. This remains a challenging group of patients, highlighting the need to better understand non-PV mediated AF.

The utility of a novel mapping algorithm utilizing vectors and global pattern of propagation for scar-related atrial tachycardias.

BACKGROUND: Activation maps of scar-related atrial tachycardias (AT) can be challenging to interpret due to difficulty in inaccurate annotation of electrograms, and an arbitrarily predefined mapping window. A novel mapping software integrating vector data and applying an algorithmic solution taking into consideration global activation pattern has been recently described (Coherent™, Biosense Webster "Investigational"). OBJECTIVE: We aimed to assess the investigational algorithm to determine the mechanism of AT compared with the standard algorithm. METHODS: This study included patients who underwent ablation of scar-related AT using the Carto 3 and the standard activation algorithm. The mapping data were analyzed retrospectively using the investigational algorithm, and the mechanisms were evaluated by two independent electrophysiologists. RESULTS: A total of 77 scar-related AT activation maps were analyzed (89.6% left atrium, median tachycardia cycle length of 273 ms). Of those, 67 cases with a confirmed mechanism of arrhythmia were used to compare the activation software. The actual mechanism of the arrhythmia was more likely to be identified with the investigational algorithm (67.2% vs. 44.8%, p = .009). In five patients with dual-loop circuits, 3/5 (60%) were correctly identified by the investigational algorithm compared to 0/5 (0%) with the standard software. The reduced atrial voltage was prone to lead to less capable identification of mechanism (p for trend: .05). The investigational algorithm showed higher inter-reviewer agreement (Cohen's kappa .62 vs. .47). CONCLUSIONS: In patients with scar-related ATs, activation mapping algorithms integrating vector data and "best-fit" propagation solution may help in identifying the mechanism and the successful site of termination.

Attenuated heart rate recovery is associated with higher arrhythmia recurrence and mortality following atrial fibrillation ablation.

AIMS: Heart rate recovery (HRR), the decrease in heart rate occurring immediately after exercise, is caused by the increase in vagal activity and sympathetic withdrawal occurring after exercise and is a powerful predictor of cardiovascular events and mortality. The extent to which it impacts outcomes of atrial fibrillation (AF) ablation has not previously been studied. The aim of this study is to investigate the association between attenuated HRR and outcomes following AF ablation. METHODS AND RESULTS: We studied 475 patients who underwent EST within 12 months of AF ablation. Patients were categorized into normal (>12 b.p.m.) and attenuated (≤12 b.p.m.) HRR groups. Our main outcomes of interest included arrhythmia recurrence and all-cause mortality. During a mean follow-up of 33 months, 43% of our study population experienced arrhythmia recurrence, 74% of those with an attenuated HRR, and 30% of those with a normal HRR (P < 0.0001). Death occurred in 9% of patients in the attenuated HRR group compared to 4% in the normal HRR cohort (P = 0.001). On multivariable models adjusting for cardiorespiratory fitness (CRF), medication use, left atrial size, ejection fraction, and renal function, attenuated HRR was predictive of increased arrhythmia recurrence (hazard ratio 2.54, 95% confidence interval 1.86-3.47, P < 0.0001). CONCLUSION: Heart rate recovery provides additional valuable prognostic information beyond CRF. An impaired HRR is associated with significantly higher rates of arrhythmia recurrence and death following AF ablation.

Impact of risk-factor modification on arrhythmia recurrence among morbidly obese patients undergoing atrial fibrillation ablation.

BACKGROUND: Morbid obesity is associated with prohibitively high arrhythmia recurrence rates following atrial fibrillation (AF) ablation. DESIGN: This was a single-center study comprising 239 patients with morbid obesity and symptomatic paroxysmal or persistent AF undergoing AF ablation compared to 239 patients with a body mass index less than 30 kg/m2 matched based on age, sex, ejection fraction, AF type, presence and type of heart failure, and left atrial volume index. METHODS: Our primary outcome of interest was arrhythmia recurrence. RESULTS: During a mean follow-up of 29 months, arrhythmia recurrence was observed in 65% of the morbidly obese cohort compared to 27% of the control group (P < .0001). Among those with morbid obesity, sleep apnea screening, and treatment (91% vs 40%; P < .0001), blood pressure control (62% vs 53%; P = .001), glycemic control (85% vs 56%; P = .004), and weight loss more than equal to 5% (33% vs 57% in those who lost less than 5% and 83% in those who gained weight, P < .0001) were associated with lower arrhythmia recurrence. Recurrent arrhythmia was observed in one (4%) patient who accomplished all four goals, compared to 36% who achieved 3 of 4, 85% who modified 2 of 4%, and 97% of those who modified zero or one risk-factor. Risk-factor modification (RFM) was also associated with substantial reductions in the need for repeat ablation or direct-current cardioversion and arrhythmia-related hospitalization (P < .0001). CONCLUSION: RFM through pragmatic noninvasive means such as blood pressure and glycemic control, sleep apnea screening and treatment, and weight loss is associated with substantially lower rates of recurrent arrhythmia among morbidly obese patients undergoing AF ablation.

Predictors of long-term outcomes greater than 10 years after cardiac resynchronization therapy implantation.

BACKGROUND: Cardiac resynchronization therapy (CRT) is indicated in patients with medically refractory heart failure and wide QRS duration. While much is known about predictors of left ventricular (LV) remodeling after CRT implantation and short-term mortality, limited data exist on long-term outcomes after CRT placement. METHODS: We retrospectively reviewed all patients undergoing CRT implantation at our center between 2003 and 2008 and examined mortality using institutional electronic records, social security death index, and online obituary search. We included only patients with preimplant echoes with LV ejection fraction (LVEF) 35% or below. Variable selection was performed using stepwise regression and models were compared using goodness-of-fit criteria. A final model was validated with the bootstrap regression method. RESULTS: Out of the 877 CRT patients undergoing implantation during this time, 287 (32.7%) survived longer than 10 years. Significant (P < .05) predictors of survival in our multivariate model were age, left ventricular diastolic diameter, sex, presence of nonischemic vs ischemic cardiomyopathy, QRS duration, atrial fibrillation, BNP levels, and creatinine levels at the time of CRT implantation. A model using the odds ratios from these variables had a receiver operating curve with an area under the curve score of 0.816 (standard error, 0.019) at predicting survival or freedom from LVAD or heart transplant for longer than 10 years after CRT implantation. The specificity for factors 3 or above and 5 or above was 68% and 77%, respectively. CONCLUSION: A large proportion of patients are still alive 10 years after CRT implantation. Variables at the time of CRT implant can help provide prognostic information to patients and electrophysiologists to determine the long-term benefit and survival of patients after CRT implantation.

Baseline Right Ventricular Dysfunction Predicts Worse Outcomes in Patients Undergoing Cardiac Resynchronization Therapy Implantation.

INTRODUCTION: Cardiac resynchronization therapy (CRT) has been shown to improve survival in patients with systolic heart failure, wide QRS duration, and left-bundle-branch-block. However, CRT outcomes stratified by right ventricular (RV) function at implant have not been well studied. METHODS: We retrospectively reviewed patients at Cleveland Clinic who underwent CRT implantation (n = 777) from 2003 to 2011 with a diagnosis of heart failure, echocardiography with both pre-CRT left ventricular ejection fraction (LVEF) ≤35% and available post-CRT echocardiography at 6 months post-implant. CRT response was defined as LVEF improvement ≥5%. Patients were separated into 2 groups: normal or mild RV dysfunction (n = 570) labeled Normal RV; moderate to severe dysfunction (n = 207) labeled RV DYSFXN based on qualitative echocardiography assessment. Survival was calculated as time from CRT implant to death, left ventricular assist device implant, or heart transplant. RESULTS: CRT response was significantly higher in patients with Normal RV (67%) compared with patients with RV DYSFXN (56%; P = .006). Kaplan-Meier analysis showed that CRT patients with Normal RV had significantly greater survival compared with patients with RV DYSFXN (P < .001). In multivariable Cox regression accounting for a priori covariates, RV DYSFXN was associated with worse survival (HR 1.41 [95% CI: 1.14-1.75], P = .002) and lower CRT response (HR 0.66 [95% CI: 0.44-0.97], P = .03). CONCLUSION: Baseline RV dysfunction at CRT implant is an important predictor of worsened left ventricular remodeling and survival in CRT patients.

Proarrhythmic effects from competitive atrial pacing and potential programming solutions.

BACKGROUND: Programmed long AV delays and intrinsic long first degree AV block may increase risk for competitive atrial pacing (CAP) in devices without CAP avoidance algorithms. METHODS: Patients identified with CAP-induced mode switch episodes were followed clinically from September 2013 to August 2019. Attempts to avoid CAP included shortening of postventricular atrial refractory period (PVARP) or postventricular atrial blanking period (PVAB), or change to AAI or DDI modes. After observing associations with sensor-driven pacing, rate response was inactivated in a subset. RESULTS: Among 23 patients identified with CAP (22 St Jude Medical [Abbott]; one Boston Scientific Corporation devices), atrial fibrillation (AF) was induced in 12 (52%), lasting 10 seconds to 28 hours and 32 minutes. In one patient with an ICD CAP-induced AF with rapid ventricular rates that triggered a shock, inducing ventricular fibrillation, syncope, and another shock. Changing AV delays and shortening of PVARP failed to resolve CAP. After noting that all had CAP during sensor-driven pacing, rate response was inactivated in seven, resolving further device-induced AF in the three of seven that had prior CAP-induced AF. In two patients with intact AV conduction, AAI(R) pacing resolved further documentation of CAP. CONCLUSIONS: CAP predominantly occurs during sensor-driven atrial pacing that competes with intrinsic atrial events falling in PVARP. Inactivation of the activity sensor or change to atrial-based pacing modes (AAI/R) appears to effectively prevent induction of device-induced atrial proarrhythmia. Ultimately, a corrective algorithm is needed to avoid CAP-induced proarrhythmia.

The gap between what patients know and desire to learn about their cardiac implantable electronic devices.

BACKGROUND: Advancement of digital technology now allows patients to have access to data from their cardiac implantable electronic devices (CIEDs). However, patients' understanding regarding CIED data and perceived personal usability remain unclear. The present study is a prospective survey to examine patients' understanding of their CIEDs and their perception of what is important. METHODS: We screened 400 patients between July and December 2018 who presented to our outpatient clinic for a CIED interrogation. Patients received a one-page questionnaire asking baseline demographics, their perception about their own knowledge about their device, and multiple-choice questions in seven basic categories: type of CIED, original indication, functionality, manufacturer, number of active leads, estimated battery life, and number of shocks received. We compared these answers to their interrogation reports to assess accuracy. We also asked participants what they would like to be aware of regarding their CIED. RESULTS: From this cohort, 344 of 400 (86%) (62.9 ± 12.8 years and 64 % males) agreed to take the survey and were included in the analysis. At baseline, 63.2% agreed or strongly agreed that they were knowledgeable about their devices. The overwhelming majority of patients demonstrated CIED knowledge deficits in at least one content area (n = 294, 86%), or more than two content areas (n = 176, 51%). Patients agreed or strongly agreed that they had a desire to have information regarding each of the following: battery life (84%), activity level (79%), heart rate trend (75%), and ventricular arrhythmias (74%). CONCLUSION: There is a large discrepancy in patients' level of knowledge regarding their CIEDs and their wish to know more details. Future technologies should satisfy providers' goals to educate their patients with basic information and fulfill patients' desire to obtain more data from their CIEDs.

Long term outcomes in patients with chronic right ventricular pacing upgraded to cardiac resynchronization therapy.

INTRODUCTION: In patients with chronic systolic heart failure and frequent right ventricular pacing (RVP), upgrade to cardiac resynchronization therapy (CRT) has become common practice despite a lack of randomized clinical trials. We aimed to evaluate long term outcomes in patients upgraded to CRT from chronic RVP compared with de novo CRT implants. METHODS AND RESULTS: We reviewed medical charts on consecutive patients with a left ventricular ejection fraction (LVEF) ≤ 35% and a QRSd ≥ 120 ms undergoing CRT. Survival free of left ventricular assist device (LVAD) and a heart transplant was compared amongst patients on the basis of pre-CRT QRS morphology. Improvement in LVEF was also compared across groups. A total of 1260 patients met inclusion criteria of whom 233 were upgraded from chronic RVP. Over a mean follow up 6.5 ± 4.0 years there were 821 endpoints (27 LVAD, 30 heart transplants, and 764 deaths). In a multivariate Cox regression model, upgraded patients had worse outcomes (HR 1.3(1.1-1.7) P = .007) compared with those with native LBBB and similar outcomes to patients with non-LBBB(HR 0.96(0.76-1.21) P = .7). The survival curve for chronic RVP parallels native LBBB for approximately 2.5 years before dropping sharply. Patients with chronic RVP derive similar improvements in LVEF compared with those with LBBB and superior improvements compared with those with non-LBBB. CONCLUSIONS: Despite achieving similar levels of LVEF improvement, patients with systolic heart failure with chronic RVP undergoing upgrade to CRT have inferior long term outcomes compared with patients with native LBBB. Long term outcomes with CRT in patients with chronic RVP, RBBB, and IVCD are similar.

Should fast pathway ablation be reconsidered in typical atrioventricular nodal re-entrant tachycardia?

INTRODUCTION: Atrioventricular nodal re-entry tachycardia (AVNRT) is the most common, regular narrow-complex tachycardia. The established treatment is catheter ablation of the AV nodal slow pathway (SP). However, in a select group of patients with long PR intervals in sinus rhythm, SP ablation can lead to AV block due to the absence of robust anterograde conduction through the fast pathway (FP). This report aims to demonstrate that AV nodal FP ablation is a reasonable approach in patients with AVNRT and poor or absent anterograde FP conduction. METHODS AND RESULTS: Standard electrophysiology study techniques were used in the electrophysiology laboratory. Catheter ablations were performed using radiofrequency energy. Mapping of intracardiac activation was performed with electroanatomical mapping systems. Outcomes were assessed acutely during the procedure and during routine clinical follow-up. Six patients with first-degree AV block and recurrent AVNRT who underwent ablation of their tachycardia at our institution are presented. One patient underwent ablation of AV nodal SP resulting in high-degree AV block necessitating pacemaker implantation. The remaining five patients underwent ablation of the AV nodal FP guided by electroanatomical mapping of the earliest atrial activation in tachycardia. These five had successful treatment of the tachycardia with preservation of anterograde AV nodal conduction. Mapping and ablation approach to eliminate retrograde FP conduction are described. CONCLUSION: In select patients with AVNRT and poor anterograde FP conduction, retrograde FP ablation is reasonable and is less likely to result in AV block and pacemaker dependency.

Percutaneous Implantation of an Entirely Intracardiac Leadless Pacemaker.

BACKGROUND: Cardiac pacemakers are limited by device-related complications, notably infection and problems related to pacemaker leads. We studied a miniaturized, fully self-contained leadless pacemaker that is nonsurgically implanted in the right ventricle with the use of a catheter. METHODS: In this multicenter study, we implanted an active-fixation leadless cardiac pacemaker in patients who required permanent single-chamber ventricular pacing. The primary efficacy end point was both an acceptable pacing threshold (≤2.0 V at 0.4 msec) and an acceptable sensing amplitude (R wave ≥5.0 mV, or a value equal to or greater than the value at implantation) through 6 months. The primary safety end point was freedom from device-related serious adverse events through 6 months. In this ongoing study, the prespecified analysis of the primary end points was performed on data from the first 300 patients who completed 6 months of follow-up (primary cohort). The rates of the efficacy end point and safety end point were compared with performance goals (based on historical data) of 85% and 86%, respectively. Additional outcomes were assessed in all 526 patients who were enrolled as of June 2015 (the total cohort). RESULTS: The leadless pacemaker was successfully implanted in 504 of the 526 patients in the total cohort (95.8%). The intention-to-treat primary efficacy end point was met in 270 of the 300 patients in the primary cohort (90.0%; 95% confidence interval [CI], 86.0 to 93.2, P=0.007), and the primary safety end point was met in 280 of the 300 patients (93.3%; 95% CI, 89.9 to 95.9; P<0.001). At 6 months, device-related serious adverse events were observed in 6.7% of the patients; events included device dislodgement with percutaneous retrieval (in 1.7%), cardiac perforation (in 1.3%), and pacing-threshold elevation requiring percutaneous retrieval and device replacement (in 1.3%). CONCLUSIONS: The leadless cardiac pacemaker met prespecified pacing and sensing requirements in the large majority of patients. Device-related serious adverse events occurred in approximately 1 in 15 patients. (Funded by St. Jude Medical; LEADLESS II ClinicalTrials.gov number, NCT02030418.).

Repeat ablation or medical management alone for recurrent arrhythmias after ablation of persistent atrial fibrillation.

INTRODUCTION: Management of persistent atrial fibrillation (PersAF) remains challenging, and many patients are left on medical therapy after a failed first ablation. In patients with recurrent symptomatic arrhythmias after PersAF ablation, we aimed to compare outcomes of repeat ablation and medical therapy versus medical therapy alone. METHODS AND RESULTS: All 682 consecutive patients with recurrent symptomatic arrhythmia after a first ablation for PersAF at our institution (2005-2012) were included. Repeat ablation with continuation of medical therapy was performed in 364 patients (Group 1) and 318 were only medically managed (Group 2). The outcome of interest was freedom from arrhythmia recurrence beyond a 3-month blanking period. Separate analyses were performed to assess this endpoint totally off antiarrhythmics (primary endpoint) or alternatively with/without use of antiarrhythmics (secondary endpoint). Over a median follow-up of 26 months, 41.5% of Group 1 patients met the primary endpoint and remained free from arrhythmia recurrence off antiarrhythmics (vs. 14.5% in Group 2, P < 0.0001). At last follow-up, antiarrhythmics continued to be required for rhythm control in 40.1% and 46.2% of patients in Groups 1 and 2, respectively (P < 0.0001). The secondary endpoint was met in 60.2% versus 32.1% of patients in Groups 1 and 2, respectively (P < 0.0001). In multivariable Cox analyses, repeat ablation was associated with significant reduction in arrhythmia recurrences compared to medical therapy alone (HR 0.48, 95% CI 0.35-0.65, P < 0.0001). CONCLUSION: In patients with recurrent symptomatic arrhythmia after ablation of PersAF, repeat ablation was associated with significant reduction in arrhythmia recurrences compared to routine medical therapy alone.

Persistent Atrial Fibrillation Ablation With or Without Contact Force Sensing.

INTRODUCTION: Arrhythmia recurrences remain common after ablation of persistent atrial fibrillation (PersAF). Contact force (CF)-sensing catheters have been introduced for objective assessment of contact during radiofrequency application and have been suggested to improve outcomes in ablation of paroxysmal AF, but little is known about their role in PersAF ablation. We aimed to compare the procedural profiles and outcomes of (PersAF) ablation with or without using CF-sensing catheters. METHODS: All consecutive patients undergoing first time ablation for PersAF between April 2014 and January 2015 at the Cleveland Clinic were included. Substrate modification was performed in addition to isolation of the pulmonary veins. Success rates were determined off antiarrhythmics over 1 year of follow-up. RESULTS: The study included 174 patients (77 CF and 97 non-CF). Ablation with CF-sensing catheters resulted in shorter procedures (median 204 vs. 216 minutes, P = 0.04) and shorter fluoroscopy time (36 vs. 48 minutes, P = 0.0005), without statistical difference in radiation dose (225 vs. 270 milligrays, P = 0.1). Arrhythmia recurrences were less likely to be observed in the CF-sensing group (27.6% vs. 46.4%, P = 0.01, log-rank P = 0.004). In multivariable Cox analyses, the use of CF-sensing catheters was associated with a lower risk of arrhythmia recurrence (hazard ratio 0.49, 95% confidence interval 0.27-0.85, P = 0.01). CONCLUSIONS: Compared to non-CF sensing, the use of CF-sensing catheters for PersAF ablation is associated with shorter procedures, shorter fluoroscopy time, and reduction in arrhythmia recurrences.

2017 ISHNE-HRS expert consensus statement on ambulatory ECG and external cardiac monitoring/telemetry.

Ambulatory ECG (AECG) is very commonly employed in a variety of clinical contexts to detect cardiac arrhythmias and/or arrhythmia patterns which are not readily obtained from the standard ECG. Accurate and timely characterization of arrhythmias is crucial to direct therapies that can have an important impact on diagnosis, prognosis or patient symptom status. The rhythm information derived from the large variety of AECG recording systems can often lead to appropriate and patient-specific medical and interventional management. The details in this document provide background and framework from which to apply AECG techniques in clinical practice, as well as clinical research.

Association Between Off-site Central Monitoring Using Standardized Cardiac Telemetry and Clinical Outcomes Among Non-Critically Ill Patients.

IMPORTANCE: Telemetry alarms involving traditional on-site monitoring rarely alter management and often miss serious events, sometimes resulting in death. Poor patient selection contributes to a high alarm volume with low clinical yield. OBJECTIVE: To evaluate outcomes associated with an off-site central monitoring unit (CMU) applying standardized cardiac telemetry indications using electronic order entry. DESIGN, SETTING, AND PARTICIPANTS: All non-intensive care unit (ICU) patients at Cleveland Clinic and 3 regional hospitals over 13 months between March 4, 2014, and April 4, 2015. EXPOSURES: An off-site CMU applied standardized cardiac telemetry when ordered for standard indications, such as for known or suspected tachyarrhythmias or bradyarrhythmias. MAIN OUTCOMES AND MEASURES: CMU detection and notification of rhythm/rate alarms occurring 1 hour or less prior to emergency response team (ERT) activation, direct CMU-to-ERT notification outcomes, total telemetry census, and cardiopulmonary arrests in comparison with the previous 13 months. RESULTS: The CMU received electronic telemetry orders for 99,048 patients (main campus, 72,199 [73%]) and provided 410,534 notifications (48% arrhythmia/hemodynamic) among 61 nursing units. ERT activation occurred among 3243 patients, including 979 patients (30%) with rhythm/rate changes occurring 1 hour or less prior to the ERT activation. The CMU detected and provided accurate notification for 772 (79%) of those events. In addition, the CMU provided discretionary direct ERT notification for 105 patients (ventricular tachycardia, n = 44; pause/asystole, n = 36; polymorphic ventricular tachycardia/ventricular fibrillation, n = 14; other, n = 11), including advance warning of 27 cardiopulmonary arrest events (26%) for which return of circulation was achieved in 25 patients (93%). Telemetry standardization was associated with a mean 15.5% weekly census reduction in the number of non-ICU monitored patients per week when compared with the prior 13-month period (580 vs 670 patients; mean difference, -90 patients [95% CI, -82 to -99]; P < .001). The number of cardiopulmonary arrests was 126 in the 13 months preintervention and 122 postintervention. CONCLUSIONS AND RELEVANCE: Among non-critically ill patients, use of standardized cardiac telemetry with an off-site central monitoring unit was associated with detection and notification of cardiac rhythm and rate changes within 1 hour prior to the majority of ERT activations, and also with a reduction in the census of monitored patients, without an increase in cardiopulmonary arrest events.

Novel Oral Anticoagulants for DC Cardioversion Procedures: Utilization and Clinical Outcomes Compared with Warfarin.

BACKGROUND: Novel oral anticoagulant (NOAC) agents dabigatran, rivaroxaban, and apixaban are increasingly utilized as thromboembolic prevention for patients with atrial fibrillation undergoing direct current cardioversion (DCCV) with post hoc analyses of clinical trials suggesting satisfactory safety and efficacy. This study characterizes utilization, effectiveness, and complications of NOAC agents for stroke prophylaxis in the setting of DCCV. METHODS: Comparison of warfarin and NOAC agents as periprocedural anticoagulation for DCCV procedures performed at Cleveland Clinic from January 2009 through December 2013. Variables of interest include utilization rates for each NOAC agent stratified by clinical parameters including CHADS2 score, and associated clinical outcomes including cerebrovascular accident (CVA), transient ischemic attack (TIA), peripheral arterial embolism (PAE), and bleeding events during 8 weeks of postprocedure follow-up. RESULTS: Among 5,320 DCCV procedures, 673 (12.6%) cases were excluded due to inadequate follow-up. Warfarin was utilized in 3,721 (80.1%), dabigatran in 719 (15.5%), rivaroxaban in 159 (3.4%), and apixaban in 48 (1.0%) with a steady increase in NOAC utilization from 2011 to 2013. There were low rates of CVA/TIA (warfarin: 0.97% vs NOAC 1.62%, P = 0.162) and bleeding (warfarin: 1.02% vs NOAC: 0.5%, P = 0.247) and no significant differences detected between agents. Higher CHADS2 /CHA2 DS2 -VASC scores were associated with thromboembolic and bleeding risk. Increasing age, chronic kidney disease, diabetes, coronary disease, and deep vein thrombosis/pulmonary embolism were associated with increased bleeding risk. CONCLUSION: In a high-volume, single-center experience, NOAC utilization has grown to account for over a third of cardioversion procedures, and these agents appear safe and effective compared to warfarin with low rates of thromboembolic and bleeding complications.

A clinical prediction rule to identify patients at heightened risk for early demise following cardiac resynchronization therapy.

BACKGROUND: In patients with advanced heart failure, the decision of whether to pursue cardiac resynchronization therapy (CRT) or to proceed directly to advanced heart failure therapies can be challenging. We sought to create a prediction rule to identify patients with advanced systolic heart failure at heightened risk of rapid deterioration despite receiving CRT. METHODS: Clinical data were collected on consecutive patients with advanced heart failure presenting for a new CRT device at the Cleveland Clinic between February 12, 2002 and July 8, 2008. Early demise was defined as death, left ventricular assist device, or heart transplant within 6 months following CRT implant. Using a multivariate model, variables associated with early demise were identified and a prediction rule created. RESULTS: A total of 879 patients were included of whom 47 met criteria for early demise. Using forward stepwise regression followed by a bootstrapping analysis, the final model included: left ventricular end-diastolic diameter ≥6.5 cm (OR 3.23 [1.72-6.06 g], P < 0.001), the presence of a non-left bundle branch block (non-LBBB) morphology (OR 2.18 [1.18-4.04, P = 0.013]), creatinine ≥1.5 mg/dL (OR 2.98 [1.52-5.49], P < 0.001), and lack of or intolerance to ß-blocker use (OR 2.80 [1.46-5.39], P = 0.002). The specificity for ≥2 and ≥3 risk factors was 72.6% and 94.6%, respectively. CONCLUSIONS: Left ventricular dilatation, the presence of a non-LBBB morphology, renal dysfunction, and lack of or intolerance to ß-blockers are associated with early demise following CRT. In patients with at least 3 of these factors, bypassing CRT with early adoption of advanced heart failure therapies may be considered given the high specificity for rapid decline.