Quality indicators for the care and outcomes of adults with atrial fibrillation.

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.

Liposomal bupivacaine during subcutaneous implantable cardioverter defibrillator implantation for pain management.

BACKGROUND: The subcutaneous implantable cardioverter-defibrillator (S-ICD) has a larger generator and its implantation involves more dissection and tunneling compared to traditional transvenous defibrillator system. Liposomal bupivacaine, an extended-release bupivacaine with 72 h of duration has been used for postoperative pain management in patients undergoing S-ICD implantation. Our aim was to compare postoperative pain and opioid prescription patterns among patients undergoing S-ICD implantation who received intraprocedural liposomal bupivacaine and those who did not. METHODS: We performed a retrospective analysis of all patients who underwent subcutaneous ICD implantation from January 1, 2013 to March 30, 2018 at the Mayo Clinic in Rochester, Minnesota. Patients were categorized into those who received liposomal bupivacaine and those who did not. Data on inpatient pain score, outpatient opioid prescription rates at discharge, and doses based on oral morphine equivalents (OME) were collected. RESULTS: A total of 104 patients underwent S-ICD implantation. Intraprocedural liposomal bupivacaine was used in 69% of patients. Patients who received intraprocedural liposomal bupivacaine had similar mean inpatient pain scores (2.9 vs. 2.9, p = .786). There was also no difference in the rate of inpatient opioid administration (79.2% vs. 87.5%, p = .4139), outpatient opioid prescription (23.6% vs. 12.5%, p = .29), or mean OME (41.7-mg vs. 16.6-mg, p = .188) when comparing patients those who received intraprocedural liposomal bupivacaine and those who did not. CONCLUSION: Intraprocedural liposomal bupivacaine administration was not associated with any significant impact on postoperative pain scores, inpatient opioid administration, and outpatient opioid prescription rates or OME amounts at discharge.

Systematic Review for the 2017 AHA/ACC/HRS Guideline for Management of Patients With Ventricular Arrhythmias and the Prevention of Sudden Cardiac Death: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines and the Heart Rhythm Society.

BACKGROUND: Although large randomized clinical trials have found that primary prevention use of an implantable cardioverter-defibrillator (ICD) improves survival in patients with cardiomyopathy and heart failure symptoms, patients who receive ICDs in practice are often older and have more comorbidities than patients who were enrolled in the clinical trials. In addition, there is a debate among clinicians on the usefulness of electrophysiological study for risk stratification of asymptomatic patients with Brugada syndrome. AIM: Our analysis has 2 objectives. First, to evaluate whether ventricular arrhythmias (VAs) induced with programmed electrostimulation in asymptomatic patients with Brugada syndrome identify a higher risk group that may require additional testing or therapies. Second, to evaluate whether implantation of an ICD is associated with a clinical benefit in older patients and patients with comorbidities who would otherwise benefit on the basis of left ventricular ejection fraction and heart failure symptoms. METHODS: Traditional statistical approaches were used to address 1) whether programmed ventricular stimulation identifies a higher-risk group in asymptomatic patients with Brugada syndrome and 2) whether ICD implantation for primary prevention is associated with improved outcomes in older patients (>75 years of age) and patients with significant comorbidities who would otherwise meet criteria for ICD implantation on the basis of symptoms or left ventricular function. RESULTS: Evidence from 6 studies of 1138 asymptomatic patients were identified. Brugada syndrome with inducible VA on electrophysiological study was identified in 390 (34.3%) patients. To minimize patient overlap, the primary analysis used 5 of the 6 studies and found an odds ratio of 2.3 (95% CI: 0.63-8.66; P=0.2) for major arrhythmic events (sustained VAs, sudden cardiac death, or appropriate ICD therapy) in asymptomatic patients with Brugada syndrome and inducible VA on electrophysiological study versus those without inducible VA. Ten studies were reviewed that evaluated ICD use in older patients and 4 studies that evaluated unique patient populations were identified. In our analysis, ICD implantation was associated with improved survival (overall hazard ratio: 0.75; 95% confidence interval: 0.67-0.83; P<0.001). Ten studies were identified that evaluated ICD use in patients with various comorbidities including renal disease, chronic obstructive pulmonary disease, atrial fibrillation, heart disease, and others. A random effects model demonstrated that ICD use was associated with reduced all-cause mortality (overall hazard ratio: 0.72; 95% confidence interval: 0.65-0.79; P<0.0001), and a second "minimal overlap" analysis also found that ICD use was associated with reduced all-cause mortality (overall hazard ratio: 0.71; 95% confidence interval: 0.61-0.82; P<0.0001). In 5 studies that included data on renal dysfunction, ICD implantation was associated with reduced all-cause mortality (overall hazard ratio: 0.71; 95% confidence interval: 0.60-0.85; P<0.001).

Mortality and Cerebrovascular Events After Heart Rhythm Disorder Management Procedures.

BACKGROUND: Recognition of rates and causes of hard, patient-centered outcomes of death and cerebrovascular events (CVEs) after heart rhythm disorder management (HRDM) procedures is an essential step for the development of quality improvement programs in electrophysiology laboratories. Our primary aim was to assess and characterize death and CVEs (stroke or transient ischemic attack) after HRDM procedures over a 17-year period. METHODS: We performed a retrospective cohort study of all patients undergoing HRDM procedures between January 2000 and November 2016 at the Mayo Clinic. Patients from all 3 tertiary academic centers (Rochester, Phoenix, and Jacksonville) were included in the study. All in-hospital deaths and CVEs after HRDM procedures were identified and were further characterized as directly or indirectly related to the HRDM procedure. Subgroup analysis of death and CVE rates was performed for ablation, device implantation, electrophysiology study, lead extraction, and defibrillation threshold testing procedures. RESULTS: A total of 48 913 patients (age, 65.7±6.6 years; 64% male) who underwent a total of 62 065 HRDM procedures were included in the study. The overall mortality and CVE rates in the cohort were 0.36% (95% confidence interval [CI], 0.31-0.42) and 0.12% (95% CI, 0.09-0.16), respectively. Patients undergoing lead extraction had the highest overall mortality rate at 1.9% (95% CI, 1.34-2.61) and CVE rate at 0.62% (95% CI, 0.32-1.07). Among patients undergoing HRDM procedures, 48% of deaths directly related to the HDRM procedure were among patients undergoing device implantation procedures. Overall, cardiac tamponade was the most frequent direct cause of death (40%), and infection was the most common indirect cause of death (29%). The overall 30-day mortality rate was 0.76%, with the highest being in lead extraction procedures (3.08%), followed by device implantation procedures (0.94%). CONCLUSIONS: Half of the deaths directly related to an HRDM procedure were among the patients undergoing device implantation procedures, with cardiac tamponade being the most common cause of death. This highlights the importance of the development of protocols for the quick identification and management of cardiac tamponade even in procedures typically believed to be lower risk such as device implantation.

Retained cardiac implantable electronic device fragments are not associated with magnetic resonance imaging safety issues, morbidity, or mortality after orthotopic heart transplant.

BACKGROUND: Cardiac implantable electronic device therapy (CIED) has revolutionized treatment for advanced heart failure. Most patients considered for orthotopic heart transplantation (OHT) are treated with implantable cardioverter defibrillators, cardiac resynchronization therapy, or both. These CIEDs are surgically extracted at the time of transplant. Occasionally, CIEDs are incompletely removed. Little is known about the outcomes of post-OHT patients with retained CIED fragments. METHODS: We identified 200 consecutive patients that underwent OHT at our institution between April 2006 and December 2014 and performed a retrospective analysis of available radiographic images and clinical records. Chest radiographs prior to and following OHT were reviewed for the presence of CIED or retained CIED fragments. The outcomes of patients with retained CIED fragments that had subsequent magnetic resonance imaging (MRI) studies performed were further investigated. RESULTS: One hundred eighty of 200 patients were identified as having CIED prior to OHT, of which 29 had retained CIED fragments after OHT. Most retained CIED fragments originated from superior vena cava defibrillator coils. There were no adverse events in the retained CIED fragment cohort, and survival was unaffected. Ten patients with retained CIED fragments safely underwent a total of 28 MRIs after OHT, all of diagnostic quality. CONCLUSION: Retained CIED fragments are not associated with adverse events or increased mortality after OHT. Diagnostic MRI has been safely performed in patients with retained CIED fragments after incomplete device extraction. Retrieval of these fragments prior to MRI does not appear warranted given the demonstrated safety and preserved image quality in this population.

Challenges and Controversies in Peer Review: JACC Review Topic of the Week.

The process of peer review has been the gold standard for evaluating medical science, but significant pressures from the recent COVID-19 pandemic, new methods of communication, larger amounts of research, and an evolving publication landscape have placed significant pressures on this system. A task force convened by the American College of Cardiology identified the 5 most significant controversies associated with the current peer-review process: the effect of preprints, reviewer blinding, reviewer selection, reviewer incentivization, and publication of peer reviewer comments. Although specific solutions to these issues will vary, regardless of how scientific communication evolves, peer review must remain an essential process for ensuring scientific integrity, timely dissemination of information, and better patient care. In medicine, the peer-review process is crucial because harm can occur if poor-quality data or incorrect conclusions are published. With the dramatic increase in scientific publications and new methods of communication, high-quality peer review is more important now than ever.

Statement from the Asia Summit: Current state of arrhythmia care in Asia.

On May 27, 2022, the Asia Pacific Heart Rhythm Society and the Heart Rhythm Society convened a meeting of leaders from different professional societies of healthcare providers committed to arrhythmia care from the Asia Pacific region. The overriding goals of the meeting were to discuss clinical and health policy issues that face each country for providing care for patients with electrophysiologic issues, share experiences and best practices, and discuss potential future solutions. Participants were asked to address a series of questions in preparation for the meeting. The format of the meeting was a series of individual country reports presented by the leaders from each of the professional societies followed by open discussion. The recorded presentations from the Asia Summit can be accessed at https://www.heartrhythm365.org/URL/asiasummit-22. Three major themes arose from the discussion. First, the major clinical problems faced by different countries vary. Although atrial fibrillation is common throughout the region, the most important issues also include more general issues such as hypertension, rheumatic heart disease, tobacco abuse, and management of potentially life-threatening problems such as sudden cardiac arrest or profound bradycardia. Second, there is significant variability in the access to advanced arrhythmia care throughout the region due to differences in workforce availability, resources, drug availability, and national health policies. Third, collaboration in the area already occurs between individual countries, but no systematic regional method for working together is present.

How to perform extrathoracic venous access for cardiac implantable electronic device placement: Detailed description of techniques.

Venous access is needed for implantation of cardiac implantable electronic devices (CIEDs) with endocardial leads. Extrathoracic venous access in the prepectoral region has become the standard of care for CIED implantation because of lower risks for pneumothorax and likely less lead malfunction due to subclavian crush syndrome. The most common extrathoracic venous access sites in the pectoral region are extrathoracic subclavian vein access, axillary vein access, and cephalic vein access. This review provides a detailed description of the anatomy, technical considerations, and relative advantages and disadvantages of each of these extrathoracic venous access sites.

Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States.

OBJECTIVES: The aim of this study was to report 1-year clinical outcomes following commercial transcatheter left atrial appendage occlusion (LAAO) in the United States. BACKGROUND: The National Cardiovascular Data Registry LAAO Registry was initiated to meet a condition of Medicare coverage and allow the assessment of clinical outcomes. The 1-year rates of thromboembolic events after transcatheter LAAO in such a large cohort of "real-world" patients have not been previously reported. METHODS: Patients entered into the National Cardiovascular Data Registry LAAO Registry for a Watchman procedure between January 1, 2016, and December 31, 2018, were included. The primary endpoint was ischemic stroke. Key secondary endpoints included the rate of ischemic stroke or systemic embolism, mortality, and major bleeding. Major bleeding was defined as any bleeding requiring hospitalization, and/or causing a decrease in hemoglobin level > 2g/dL, and/or requiring blood transfusion that was not hemorrhagic stroke. The Kaplan-Meier method was used for 1-year estimates of cumulative event rates. RESULTS: The study population consisted of 36,681 patients. The mean age was 76.0 ± 8.1 years, the mean CHA2DS2-VASc score was 4.8 ± 1.5, and the mean HAS-BLED score was 3.0 ± 1.1. Prior stroke was present in 25.5%, clinically relevant bleeding in 69.5%, and intracranial bleeding in 11.9%. Median follow-up was 374 days (IQR: 212-425 days). The Kaplan-Meier-estimated 1-year rate of ischemic stroke was 1.53% (95% CI: 1.39%-1.69%), the rate of ischemic stroke or systemic embolism was 2.19% (95% CI: 2.01%-2.38%), and the rate of mortality was 8.52% (95% CI: 8.19%-8.87%). The 1-year estimated rate of major bleeding was 6.93% (95% CI: 6.65%-7.21%). Most bleeding events occurred between discharge and 45 days following the procedure. CONCLUSIONS: This study characterizes important outcomes in a national cohort of patients undergoing transcatheter LAAO in the United States. Clinicians and patients can integrate these data in shared decision making when considering this therapy.

Indications for Left Atrial Appendage Occlusion in the United States and Associated In-Hospital Outcomes: Results From the NCDR LAAO Registry.

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 CHA2DS2-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.

Causes of Early Mortality After Transvenous Lead Removal.

BACKGROUND: Recognition of the causes of early mortality (≤30 days) after transvenous lead removal (TLR) is an essential step for the development of quality improvement programs. OBJECTIVES: This study sought to determine the causes of early mortality after TLR and to further understand the circumstances surrounding death after TLR. METHODS: A retrospective analysis was performed of all patients undergoing TLR from January 1, 2001, to January 1, 2021, at the Mayo Clinic (Rochester, Minnesota; Phoenix, Arizona; and Jacksonville, Florida). Causes of death were identified through a detailed chart review of the electronic health record from within the Mayo Clinic system and outside records when available. The causes of death were further characterized based on whether it was related to the TLR procedure. RESULTS: A total of 2,319 patients were included in the study. The overall 30-day all-cause mortality rate was 3% (n = 69). Among all 30-day deaths, infection was the most common primary cause of death (42%). This was followed by decompensated heart failure (17%), procedure-related death (10%), sudden cardiac arrest (7%), and respiratory failure (6%). The 30-day mortality rate directly due to complications associated with the TLR procedure was 0.3%. One-third of deaths (33%) occurred after discharge from the index hospitalization; among these, 43% were readmitted before their death, 35% died at home or at a nursing facility, and 22% were discharged on comfort care and died in hospice. The main reasons for readmission before death were sepsis and decompensated heart failure. CONCLUSIONS: The majority (90%) of 30-day mortality after TLR was not due to complications associated with TLR procedures. The primary causes were infection and decompensated heart failure. This highlights the importance of increased emphasis on postprocedure management of infection and heart failure to reduce postoperative mortality, including after hospital discharge.

Opportunities and challenges in heart rhythm research: Rationale and development of an electrophysiology collaboratory.

There are many challenges in the current landscape of electrophysiology (EP) clinical and translational research, including increasing costs and complexity, competing demands, regulatory requirements, and challenges with study implementation. This review seeks to broadly discuss the state of EP research, including challenges and opportunities. Included here are results from a Heart Rhythm Society (HRS) Research Committee member survey detailing HRS members' perspectives regarding both barriers to clinical and translational research and opportunities to address these challenges. We also provide stakeholder perspectives on barriers and opportunities for future EP research, including input from representatives of the U.S. Food and Drug Administration, industry, and research funding institutions that participated in a Research Collaboratory Summit convened by HRS. This review further summarizes the experiences of the heart failure and heart valve communities and how they have approached similar challenges in their own fields. We then explore potential solutions, including various models of research ecosystems designed to identify research challenges and to coordinate ways to address them in a collaborative fashion in order to optimize innovation, increase efficiency of evidence generation, and advance the development of new therapeutic products. The objectives of the proposed collaborative cardiac EP research community are to encourage and support scientific discourse, research efficiency, and evidence generation by exploring collaborative and equitable solutions in which stakeholders within the EP community can interact to address knowledge gaps, innovate, and advance new therapies.

Outcome of implantable cardioverter defibrillator in cardiac sarcoidosis: a systematic review and meta-analysis.

PURPOSE: Cardiac sarcoidosis is a multisystem inflammatory disorder characterized by ventricular arrhythmias. Implantable cardioverter defibrillator (ICD) is used to prevent sudden cardiac death. METHODS: We performed literature search for studies that addressed the outcome and complications of ICD in Cardiac Sarcoidosis (CS). Multiple search sites were reviewed from January 1, 2000 until December 1, 2018. We then performed a meta-analysis using a random effects model. Two investigators independently extracted the data and assessed studies' quality. RESULTS: Ten studies with 585 patients qualified for the analysis. In the pooled analysis, 57% were male with mean left ventricular ejection fraction (LVEF) of 38.4%. Appropriate and inappropriate ICD treatments (AT and IAT) were reported in 39% and 15% of patients respectively over mean follow-up period of 25 months and mortality rate of 8%. A sub-analysis of four studies indicated that patients with appropriate therapy did not differ from the rest of CS population in LVEF% (mean difference (MD) = - 7.37%, 95% confidence interval (CI) - 16.89 to 2.15, p = 0.12), age (MD = - 3.87 years, 95% CI - 10.19 to 2.46, p = 0.23), primary prevention (range difference (RD) = - 0.11, 95% CI - 0.31 to 0.10, p = 0.31) or secondary prevention indication (RD = 0.09, 95% CI - 0.12 to 0.3, p = 0.37). High degree AV block was more common in patients with AT (RD = 0.07, 95% CI 0.00 to 0.14 p = 0.05). CONCLUSIONS: ICD placement in CS is associated with high incidence of both appropriate and inappropriate therapy. High degree AV block appears to be predictive of appropriate ICD therapy.

The NCDR Left Atrial Appendage Occlusion Registry.

BACKGROUND: Left atrial appendage occlusion (LAAO) to prevent stroke in patients with atrial fibrillation has been evaluated in 2 randomized trials; post-approval clinical data are limited. OBJECTIVES: The purpose of this study was to describe the National Cardiovascular Data Registry (NCDR) LAAO Registry and present patient, hospital, and physician characteristics and in-hospital adverse event rates for Watchman procedures in the United States during its first 3 years. METHODS: The authors describe the LAAO Registry structure and governance, the outcome adjudication processes, and the data quality and collection processes. They characterize the patient population, performing hospitals, and in-hospital adverse event rates. RESULTS: A total of 38,158 procedures from 495 hospitals performed by 1,318 physicians in the United States were included between January 2016 and December 2018. The mean patient age was 76.1 ± 8.1 years, the mean CHA2DS2-VASc (congestive heart failure, hypertension, 65 years of age and older, diabetes mellitus, previous stroke or transient ischemic attack, vascular disease, 65 to 74 years of age, female) score was 4.6 ± 1.5, and the mean HAS-BLED (hypertension, abnormal renal/liver function, stroke, bleeding history or predisposition, labile international normalized ratio, elderly, drugs/alcohol concomitantly) score was 3.0 ± 1.1. The median annual number of LAAO procedures performed for hospitals was 30 (interquartile range: 18 to 44) and for physicians was 12 (interquartile range: 8 to 20). Procedures were canceled or aborted in 7% of cases; among cases in which a device was deployed, 98.1% were implanted with <5-mm leak. Major in-hospital adverse events occurred in 2.16% of patients; the most common complications were pericardial effusion requiring intervention (1.39%) and major bleeding (1.25%), whereas stroke (0.17%) and death (0.19%) were rare. CONCLUSIONS: The LAAO Registry has enrolled >38,000 patients implanted with the device. Patients were generally older with more comorbidities than those enrolled in the pivotal trials; however, major in-hospital adverse event rates were lower than reported in those trials.