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.

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.

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.

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.

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.

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.

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.

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.

Guidance for Rebooting Electrophysiology Through the COVID-19 Pandemic From the Heart Rhythm Society and the American Heart Association Electrocardiography and Arrhythmias Committee of the Council on Clinical Cardiology: Endorsed by the American College of Cardiology.

Coronavirus disease 2019 (COVID-19) has presented substantial challenges to patient care and impacted health care delivery, including cardiac electrophysiology practice throughout the globe. Based upon the undetermined course and regional variability of the pandemic, there is uncertainty as to how and when to resume and deliver electrophysiology services for arrhythmia patients. This joint document from representatives of the Heart Rhythm Society, American Heart Association, and American College of Cardiology seeks to provide guidance for clinicians and institutions reestablishing safe electrophysiological care. To achieve this aim, we address regional and local COVID-19 disease status, the role of viral screening and serologic testing, return-to-work considerations for exposed or infected health care workers, risk stratification and management strategies based on COVID-19 disease burden, institutional preparedness for resumption of elective procedures, patient preparation and communication, prioritization of procedures, and development of outpatient and periprocedural care pathways.

Guidance for Rebooting Electrophysiology Through the COVID-19 Pandemic From the Heart Rhythm Society and the American Heart Association Electrocardiography and Arrhythmias Committee of the Council on Clinical Cardiology.

Coronavirus disease 2019 (COVID-19) has presented substantial challenges to patient care and impacted healthcare delivery, including cardiac electrophysiology practice throughout the globe. Based upon the undetermined course and regional variability of the pandemic, there is uncertainty as to how and when to resume and deliver electrophysiology services for patients with arrhythmia. This joint document from representatives of the Heart Rhythm Society, American Heart Association, and American College of Cardiology seeks to provide guidance for clinicians and institutions reestablishing safe electrophysiological care. To achieve this aim, we address regional and local COVID-19 disease status, the role of viral screening and serological testing, return-to-work considerations for exposed or infected health care workers, risk stratification and management strategies based on COVID-19 disease burden, institutional preparedness for resumption of elective procedures, patient preparation and communication, prioritization of procedures, and development of outpatient and periprocedural care pathways.

Guidance for rebooting electrophysiology through the COVID-19 pandemic from the Heart Rhythm Society and the American Heart Association Electrocardiography and Arrhythmias Committee of the Council on Clinical Cardiology: Endorsed by the American College of Cardiology.

Coronavirus disease 2019 (COVID-19) has presented substantial challenges to patient care and impacted health care delivery, including cardiac electrophysiology practice throughout the globe. Based upon the undetermined course and regional variability of the pandemic, there is uncertainty as to how and when to resume and deliver electrophysiology services for arrhythmia patients. This joint document from representatives of the Heart Rhythm Society, American Heart Association, and American College of Cardiology seeks to provide guidance for clinicians and institutions reestablishing safe electrophysiological care. To achieve this aim, we address regional and local COVID-19 disease status, the role of viral screening and serologic testing, return-to-work considerations for exposed or infected health care workers, risk stratification and management strategies based on COVID-19 disease burden, institutional preparedness for resumption of elective procedures, patient preparation and communication, prioritization of procedures, and development of outpatient and periprocedural care pathways.