Varosy, Paul D.

Background: The Food and Drug Administration approved left atrial appendage occlusion with the Watchman device for patients who are at increased stroke risk and are suitable for oral anticoagulation but who have an appropriate reason to seek a nondrug alternative. These broad criteria raise the question of their interpretation in clinical practice. There is a lack of studies comprehensively evaluating the indications for Watchman implantation among a large series of patients from contemporary, real-world practice in the United States. Methods: We used the National Cardiovascular Data Registry Left Atrial Appendage Occlusion Registry to identify Watchman procedures performed between 2016 and 2018. We assessed procedural indications for Watchman implantation in the United States and evaluated the association between procedural indications and in-hospital adverse events. Results: A total of 38 314 procedures were included. The mean patient age was 76.1±8.1 years, and 58.9% were men. The mean CHA 2 DS 2 -VASc score was 4.8±1.5, whereas the mean hypertension, abnormal renal/liver function, stroke, bleeding history or predisposition, labile international normalized ratio, elderly, drugs/alcohol (HAS-BLED) score was 3.0±1.1. Prior stroke or transient ischemic attack was reported in 40.2% and prior bleeding in 70.1%, with gastrointestinal bleeding being most common (41.9%). The most common site-reported procedural indications for Watchman implantation were increased thromboembolic risk (64.8%) and history of major bleed (64.3%), followed by high fall risk (35.5%). Most (71.9%) had ≥2 procedural indications. Patients with high fall risk had increased risk of in-hospital adverse events (adjusted OR, 1.12; P =0.025), but no other differences were found in the risk of in-hospital adverse events by procedural indication. Conclusions: Among patients in the National Cardiovascular Data Registry Left Atrial Appendage Occlusion Registry, the most common procedural indications for Watchman implantation were increased thromboembolic risk, history of major bleed, and high fall risk. A majority of patients had multiple procedural indications. High fall risk conferred a modestly increased risk of in-hospital adverse events.

Abstract Aims To develop quality indicators (QIs) that may be used to evaluate the quality of care and outcomes for adults with atrial fibrillation (AF). Methods and results We followed the ESC methodology for QI development. This methodology involved (i) the identification of the domains of AF care for the diagnosis and management of AF (by a group of experts including members of the ESC Clinical Practice Guidelines Task Force for AF); (ii) the construction of candidate QIs (including a systematic review of the literature); and (iii) the selection of the final set of QIs (using a modified Delphi method). Six domains of care for the diagnosis and management of AF were identified: (i) Patient assessment (baseline and follow-up), (ii) Anticoagulation therapy, (iii) Rate control strategy, (iv) Rhythm control strategy, (v) Risk factor management, and (vi) Outcomes measures, including patient-reported outcome measures (PROMs). In total, 17 main and 17 secondary QIs, which covered all six domains of care for the diagnosis and management of AF, were selected. The outcome domain included measures on the consequences and treatment of AF, as well as PROMs. Conclusion This document defines six domains of AF care (patient assessment, anticoagulation, rate control, rhythm control, risk factor management, and outcomes), and provides 17 main and 17 secondary QIs for the diagnosis and management of AF. It is anticipated that implementation of these QIs will improve the quality of AF care.

Background In US clinical practice, many patients who undergo placement of an implantable cardioverter‐defibrillator ( ICD ) for primary prevention of sudden cardiac death receive dual‐chamber devices. The superiority of dual‐chamber over single‐chamber devices in reducing the risk of inappropriate ICD shocks in clinical practice has not been established. The objective of this study was to compare risk of adverse outcomes, including inappropriate shocks, between single‐ and dual‐chamber ICD s for primary prevention. Methods and Results We identified patients receiving a single‐ or dual‐chamber ICD for primary prevention who did not have an indication for pacing from 15 hospitals within 7 integrated health delivery systems in the Longitudinal Study of Implantable Cardioverter‐Defibrillators from 2006 to 2009. The primary outcome was time to first inappropriate shock. ICD shocks were adjudicated for appropriateness. Other outcomes included all‐cause hospitalization, heart failure hospitalization, and death. Patient, clinician, and hospital‐level factors were accounted for using propensity score weighting methods. Among 1042 patients without pacing indications, 54.0% (n=563) received a single‐chamber device and 46.0% (n=479) received a dual‐chamber device. In a propensity‐weighted analysis, device type was not significantly associated with inappropriate shock (hazard ratio, 0.91; 95% confidence interval, 0.59–1.38 [ P =0.65]), all‐cause hospitalization (hazard ratio, 1.03; 95% confidence interval, 0.87–1.21 [ P =0.76]), heart failure hospitalization (hazard ratio, 0.93; 95% confidence interval, 0.72–1.21 [ P =0.59]), or death (hazard ratio, 1.19; 95% confidence interval, 0.93–1.53 [ P =0.17]). Conclusions Among patients who received an ICD for primary prevention without indications for pacing, dual‐chamber devices were not associated with lower risk of inappropriate shock or differences in hospitalization or death compared with single‐chamber devices. This study does not justify the use of dual‐chamber devices to minimize inappropriate shocks.

Background— The ICD Registry was established in 2006 in part to measure quality of care in patients undergoing implantation of implantable cardioverter-defibrillators (ICDs); however, whether outcomes have improved since initiation of the registry is unknown. Our objective was to examine changes over time in 3 quality metrics available from the registry. Methods and Results— We performed an observational study of 367 153 patients who received new ICD implants from April 2006 to March 2010. Three quality metrics were selected: Adverse events (in-hospital complications or mortality), optimal medical therapy (OMT), and cardiac resynchronization therapy (CRT). OMT was defined as prescription of β-blocker and either angiotensin-converting enzyme inhibitor or angiotensin receptor blocker in eligible patients. CRT eligibility was determined by QRS ≥120 ms, left ventricular ejection fraction ≤35%, and New York Heart Association class III/IV. Observation periods were divided into four 12-month intervals. We analyzed changes over time and used hierarchical logistic regression to adjust for potential confounders. Adverse events decreased over time (3.7% to 2.8%, P <0.001). Among eligible patients, rates of OMT and CRT increased over time (OMT: 69.0% to 74.3%, P <0.001; CRT: 80.5% to 84.2%, P <0.001). After adjustment for potential confounders, patients were significantly less likely to experience adverse events in year 4 than in year 1 (odds ratio, 0.75; 95% confidence interval, 0.71–0.79) and significantly more likely to receive OMT (odds ratio, 1.29; 95% confidence interval, 1.26–1.32) and CRT (odds ratio, 1.42; 95% confidence interval, 1.35–1.49). Conclusions— Since initiation of the ICD Registry, adverse events have been decreasing, and rates of OMT and CRT among eligible patients have been increasing, although there is still significant room for improvement.