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The aim of this study was to create a simple risk index to predict new-onset atrial fibrillation (AF) after coronary artery bypass grafting in patients with histories of AF. AF after coronary artery bypass grafting (referred to here as AF) is associated with increased morbidity and mortality. Identifying patients at high risk for developing AF may help identify a group of patients who might benefit from strategies to prevent postoperative AF. A cohort of 18,517 patients enrolled from January 1, 1996, to December 31, 2009, was used to derive a risk index for AF prediction. A multivariate logistic regression model determined the independent predictive impact of clinical and demographic characteristics on the occurrence of AF. A subset of these variables was used to construct a risk index to predict AF. This risk index was validated in a sequential cohort of 1,378 consecutive patients who underwent coronary artery bypass grafting from January 1, 2010, to June 30, 2011. AF occurred in 3,486 patients in the calibration cohort (18.83%) and in 269 patients in the validation cohort (19.52%). After considering patients' demographics, co-morbid conditions, and severity of illness, advanced age appeared as the most powerful predictor of AF (odds ratio 1.059/year, 95% confidence interval 1.055 to 1.063). Age, height, weight, and the presence of peripheral vascular disease contributed most to the prediction model. An AF risk index including these variables had adequate discriminatory power, with a concordance index of 0.68. In conclusion, using a large cohort of patients, a simple risk index relying only on preoperative clinical variables was developed, which will help predict AF. This risk index can be used clinically to identify patients at high risk for the development of AF.

Leadless pacing is an emerging technology with the potential to significantly improve outcomes associated with the need for long-term pacing. Specifically, the major advantage of leadless systems is abolishing the need for transvenous leads and subcutaneous pockets, both of which account for most adverse events associated with traditional pacemakers. Two leadless pacemakers are currently available: the Nanostim (leadless cardiac pacemaker [LCP]) device (St. Jude Medical, Sylmar, California) and the Micra Transcatheter pacing system (Medtronic, Minneapolis, Minnesota). These 2 pacemakers have shown promising results in clinical trials. In conclusion, in this review we summarize the results of the 2 investigational device exemption trials and compare the pros and cons of these devices to traditional transvenous pacemakers.

Abstract Background T wave oversensing (TWOS) is a major drawback of the subcutaneous implantable cardioverter defibrillator (S-ICD). Data on predictors of TWOS in S-ICD recipients are limited. We sought to investigate predictors of TWOS in a cohort of patients receiving an S-ICD at our institution. Methods S-ICD recipients at our center were identified retrospectively and stratified based on the presence or absence of TWOS. Clinical and electrocardiographic parameters were collected and compared between the 2 groups. Results Ninety-two patients underwent an S-ICD implantation at our institution between April 2010 and January 2015. Six (6.5%) patients had TWOS. These patients were younger (38.1±13.7 vs. 52.3±16.1 years, p =0.04) and had higher left ventricle ejection fractions (48.5±14.9% vs. 28.4±12.2%, p <0.01) than patients without a history of TWOS. Baseline 12-lead electrocardiogram (ECG) parameters were not different between the 2 groups. Leads I, II, and avF (which mimic the sensing vectors of the S-ICD) were further inspected to identify ECG characteristics that could predict TWOS. The QRS amplitude in ECG lead I was significantly smaller in the TWOS group than in the non-TWOS group (3.7 vs. 7.4 mV, p =0.02). Conclusion In this study, younger age, higher ejection fraction, and lower QRS amplitude were associated with TWOS. These findings could help identify patients referred for S-ICD at high-risk of TWOS.

Abstract Background The efficacy of implantable cardioverter-defibrillators (ICD) for primary prevention of sudden cardiac death (SCD) has not been studied in patients with end-stage renal disease (ESRD) and left ventricular dysfunction. We sought to identify predictors of long-term survival among ICD recipients with and without ESRD. Methods Patients implanted with an ICD at our institution from January 2006 to March 2014 were retrospectively identified. Clinical and demographic characteristics were collected. Patients were stratified by the presence of ESRD at the time of ICD implant. Mortality data were collected from the Social Security Death Index (SSDI). Results A total of 3453 patients received an ICD at our institution in the pre-specified time period, 184 (5.3%) of whom had ESRD. In general, ESRD patients were sicker and had more comorbidities. Kaplan Meier survival curve showed that ESRD patients had worse survival as compared with non-dialysis patients ( p <0.001). Following adjustment for differences in baseline characteristics, patients with ESRD remained at increased long-term mortality in the Cox model. The one-year mortality in the ESRD patients was 18.1%, as compared with 7.7% in the non-dialysis cohort ( p <0.001). The three-year mortality in ESRD patients was 43%, as compared with 21% in the non-dialysis cohort ( p <0.001). Conclusion ESRD patients are at significantly increased risk of mortality as compared with a non-dialysis cohort. While the majority of these patients survive more than one year post-diagnosis, the three-year mortality is high (43%). Randomized studies addressing the benefits of ICDs in ESRD patients are needed to better define their value for primary prevention of SCD.

Patients with an indication for an implantable cardioverter–defibrillator but no indication for pacing were randomly assigned to a subcutaneous or a transvenous ICD. At 49 months, the subcutaneous ICD was noninferior to the transvenous ICD with respect to device-related complications and inappropriate shocks.

Continuous automatic optimisation of cardiac resynchronisation therapy (CRT), stimulating only the left ventricle to fuse with intrinsic right bundle conduction (synchronised left ventricular stimulation), might offer better outcomes than conventional CRT in patients with heart failure, left bundle branch block, and normal atrioventricular conduction. This study aimed to compare clinical outcomes of adaptive CRT versus conventional CRT in patients with heart failure with intact atrioventricular conduction and left bundle branch block. This global, prospective, randomised controlled trial was done in 227 hospitals in 27 countries across Asia, Australia, Europe, and North America. Eligible patients were aged 18 years or older with class 2–4 heart failure, an ejection fraction of 35% or less, left bundle branch block with QRS duration of 140 ms or more (male patients) or 130 ms or more (female patients), and a baseline PR interval 200 ms or less. Patients were randomly assigned (1:1) via block permutation to adaptive CRT (an algorithm providing synchronised left ventricular stimulation) or conventional biventricular CRT using a device programmer. All patients received device programming but were masked until procedures were completed. Site staff were not masked to group assignment. The primary outcome was a composite of all-cause death or intervention for heart failure decompensation and was assessed in the intention-to-treat population. Safety events were collected and reported in the intention-to-treat population. This study is registered with ClinicalTrials.gov, NCT02205359, and is closed to accrual. Between Aug 5, 2014, and Jan 31, 2019, of 3797 patients enrolled, 3617 (95·3%) were randomly assigned (1810 to adaptive CRT and 1807 to conventional CRT). The futility boundary was crossed at the third interim analysis on June 23, 2022, when the decision was made to stop the trial early. 1568 (43·4%) of 3617 patients were female and 2049 (56·6%) were male. Median follow-up was 59·0 months (IQR 45–72). A primary outcome event occurred in 430 of 1810 patients (Kaplan-Meier occurrence rate 23·5% [95% CI 21·3–25·5] at 60 months) in the adaptive CRT group and in 470 of 1807 patients (25·7% [23·5–27·8] at 60 months) in the conventional CRT group (hazard ratio 0·89, 95% CI 0·78–1·01; p=0·077). System-related adverse events were reported in 452 (25·0%) of 1810 patients in the adaptive CRT group and 440 (24·3%) of 1807 patients in the conventional CRT group. Compared with conventional CRT, adaptive CRT did not significantly reduce the incidence of all-cause death or intervention for heart failure decompensation in the included population of patients with heart failure, left bundle branch block, and intact AV conduction. Death and heart failure decompensation rates were low with both CRT therapies, suggesting a greater response to CRT occurred in this population than in patients in previous trials. Medtronic.

There is heightened interest in how real-world data (RWD) can be used to supplement or replace traditional mechanisms for collecting clinical information. A critical component in evaluating utility of RWD is assessing the validity and reliability of event measurement. Only two studies have validated Medicare claims with physician-adjudicated data collected in a clinical study and none in the pacemaker patient population. This study compares events identified in physician-adjudicated clinical registry data collected in the Micra Post-Approval Registry (PAR) with events identified via Medicare administrative claims in the Micra Coverage with Evidence (CED) Study. Patients who were dually enrolled in the Micra CED and the Micra PAR between March 9, 2017 and December 1, 2017 were included in the validation analysis. All patients intended to be implanted with a Micra device were eligible for participation in the Micra PAR. All Medicare fee-for-service beneficiaries implanted with a Micra device who met the 12-month continuous enrollment criteria were included in the Micra CED. We compared the count of acute (30-day) complications identified in the Medicare claims and the physician-adjudicated PAR data to assess agreement between data sources. There were 230 patients dually enrolled in the Micra CED and Micra PAR studies during the study period. Overall, there were 17 acute events reported in either the Micra CED or the Micra PAR, with 95% agreement in the identification of events and absence of events between studies. Study disagreement between events reported in either study varied: arteriovenous fistula (50%), pulmonary embolism (67%), hemorrhage/hematoma (75%), and deep vein thrombosis (100%). Among physician-adjudicated events, there was no disagreement between the Micra CED and Micra PAR studies in any event type. Findings from this study demonstrate high agreement in event identification between Medicare claims data and registries for patients implanted with Micra leadless pacemakers.

Purpose of Review Tricuspid regurgitation is a commonly encountered valvular pathology in patients with trans-tricuspid pacing or implantable cardioverter-defibrillator leads. Transcatheter tricuspid valve interventions are increasingly performed in patients at high surgical risk. Implantation of these valves can lead to the “jailing” of a trans-tricuspid lead. This practice carries both short- and long-term risks of lead failure and subsequent infection without the ability to perform traditional transvenous lead extraction. Herein, this manuscript reviews available therapeutic options for lead management in patients undergoing transcatheter tricuspid valve interventions. Recent Findings The decision to jail a lead may be appropriate in certain high-risk cases, though extraction may be a better option in most cases given the variety of options for re-implant, including leadless pacemakers, valve-sparing systems, epicardial leads, leads placed directly through prosthetic valves, and the completely subcutaneous implantable-defibrillator. Summary A growing number of patients meet the requirement for CIED implantation in the United States. A significant proportion of these patients will have tricuspid valve dysfunction, either related to or independent of their transvenous lead. As with any percutaneous intervention that has shown efficacy, the role of TTVI is also likely to increase as this therapy advances beyond the investigational phase. As such, the role of the heart team in the management of these patients will be increasingly critical in the years to come, and in those patients that have pre-existing CIED leads, we advocate for the involvement of an electrophysiologist in the heart team.

Purpose of ReviewLeadless pacemakers (LPs) are emerging as alternative cardiac implantable devices for the treatment of bradyarrhythmia. This article aims to review the data behind the safety and efficacy of these devices while highlighting their pros and cons.Recent FindingsProspective non-randomized studies and registries have found that LPs are associated with lower rate of device-related complications mainly driven by lower need for lead-related interventions as compared to traditional pacemakers. On the other hand, cardiac perforation appears to occur more frequently with LPs.SummaryLPs are associated with lower rate of device-related complications as compared to the traditional pacemakers. However, the rate of pericardial effusion is higher and is more severe. As we transition to multi-chamber LPs, it is important to ensure the safety and efficacy of these devices.