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Pulmonary congestion due to heart failure causes abnormal lung function. Cardiac resynchronization therapy (CRT) is a proven effective treatment for heart failure. The aim of this study was to test the hypothesis that CRT promotes increased lung volumes, bronchial conductance, and gas diffusion. Forty-four consecutive patients with heart failure were prospectively investigated before and after CRT. Spirometry, gas diffusion (diffusing capacity for carbon monoxide), cardiopulmonary exercise testing, New York Heart Association class, brain natriuretic peptide, the left ventricular ejection fraction, left atrial volume, and right ventricular systolic pressure were assessed before and 4 to 6 months after CRT. Pre- and post-CRT measures were compared using either paired Student's t tests or Wilcoxon's matched-pair test; p values <0.05 were considered significant. Improved New York Heart Association class, left ventricular ejection fraction, left atrial volume, right ventricular systolic pressure, and brain natriuretic peptide were observed after CRT (p <0.05 for all). Spirometry after CRT demonstrated increased percentage predicted total lung capacity (90 ± 17% vs 96 ± 15%, p <0.01) and percentage predicted forced vital capacity (80 ± 19% vs 90 ± 19%, p <0.01). Increased percentage predicted total lung capacity was significantly correlated with increased peak exercise end-tidal carbon dioxide (r = 0.43, p = 0.05). Increased percentage predicted forced vital capacity was significantly correlated with decreased right ventricular systolic pressure (r = −0.30, p = 0.05), body mass index (r = −0.35, p = 0.02) and creatinine (r = −0.49, p = 0.02), consistent with an association of improved bronchial conductance and decreased congestion. Diffusing capacity for carbon monoxide did not significantly change. In conclusion, increased lung volumes and bronchial conductance due to decreased pulmonary congestion and increased intrathoracic space contribute to an improved breathing pattern and decreased hyperventilation after CRT. Persistent alveolar-capillary membrane remodeling may account for unchanged diffusing capacity for carbon monoxide.

Hypertrophic cardiomyopathy is a genetically determined myocardial disease with a diverse natural history. 1 – 7 Since a subgroup of patients with hypertrophic cardiomyopathy are at high risk for sudden death, there has been considerable interest in risk stratification 1 , 3 , 8 – 11 and appropriate preventive measures. 3 , 11 , 12 There are few data supporting the efficacy of prophylactic treatment with amiodarone in patients with hypertrophic cardiomyopathy, 13 and the frequent adverse consequences of long-term use of this drug limit its application for the prevention of sudden death in young patients with this disease. The implantable cardioverter–defibrillator 14 is widely accepted as a definitive treatment for . . .

Atrial fibrillation is associated with increased morbidity and mortality 1 – 5 and is an independent risk factor for stroke. 6 , 7 Although the association between atrial fibrillation and mortality has been debated, a recent report showed that atrial fibrillation was associated with a mortality rate that was higher by a factor of 1.5 to 1.9 than the rate expected in the general population, after adjustment for other cardiovascular conditions. 1 The optimal goal in treating atrial fibrillation is to restore and maintain sinus rhythm — often a formidable task. Despite therapy with antiarrhythmic drugs, studies have reported recurrence rates of 50 to 60 . . .

Objective This study aimed to characterize the interactions of pacemakers with magnetic resonance imaging (MRI) and to identify device characteristics that could predict adverse interactions. Background The safety of MRI in patients with indwelling pacemaker systems remains uncertain. Previous studies demonstrated safety in most patients, but unpredictable, potentially concerning changes in pacemaker behavior have occurred. Methods We prospectively studied patients with pacemaker devices in situ who were not pacemaker dependent and in whom MRI was essential for adequate diagnosis and treatment. All patients were monitored by electrocardiography and pulse oximetry during scanning; devices were interrogated and cardiac enzymes were measured before and after scanning. Results Of 32 patients studied (46 MRI examinations), 28 patients had a dual-chamber system and one had a biventricular device. Regions scanned were the head and spine. Devices were reprogrammed to asynchronous pacing or sense-only mode in all except six patients before MRI. During six scanning episodes (five patients), “power-on” resetting of the device was noted. Magnet-mode pacing was noted during four episodes (three patients). Occasional premature ventricular contractions were noted in one patient. No significant changes in battery voltage, sensed P wave and R wave, pacing thresholds, lead impedance, or cardiac enzymes were noted immediately after MRI or at 1-month follow-up. Conclusions Overall, no significant changes were seen in pacemaker device function, and no adverse clinical events were observed. A minority of patients with older devices had unpredictable changes in device behavior, which stresses the need for close monitoring during and careful device interrogation after scanning.

With increasing coronary sinus (CS) pacemaker leads for cardiac resynchronization therapy, the need to remove these leads has risen. The purpose of this study is to describe a single center's experience with CS lead removal and to attempt to identify predictors of difficulty with lead removal and complications. We reviewed all percutaneous endocardial CS lead removals performed at our institution through February 2010. Successful removal with traction alone was considered simple while complex extractions required traction devices and/or laser sheaths. Between December 1996 and February 2010, 125 CS leads were percutaneously removed ≥1 week post-implantation from 115 patients. One attempt at CS lead extraction was unsuccessful. The average duration since implantation for the CS leads was 1.54 years (± .75 years, range 8 days to 8.24 years). The majority of the leads were removed by simple traction ( n  = 114, 91.2 %). The remainder were removed by femoral approach with snare ( n  = 3, 2.4 %), locking stylet ( n  = 2, 1.6 %), or locking stylet and laser sheath ( n  = 6, 4.8 %). Half of CS leads in place greater than 4 years required complex extraction ( n  = 7/14, 50 %). CS complications ( n  = 11 patients, 8.8 %) included CS or tributary thrombosis ( n  = 7/102, 6.9 %) and CS dissection ( n  = 4/102, 3.9 %). Major non-CS complications ( n  = 2 patients, 1.6 %) included a cardiac tear requiring pericardiocentesis and thoracotomy ( n  = 1, 0.8 %) and subclavian vein tear requiring surgical repair ( n  = 1, 0.8 %). Minor non-CS complications ( n  = 9 patients, 7.2 %) included a pneumothorax ( n  = 1, 0.8 %), hematoma ( n  = 2, 1.6 %), subclavian vein thrombosis (n = 3, x%), and blood transfusion ( n  = 5, 4.0 %). A longer duration since implantation and larger lead diameter were associated with complex versus simple removal ( p  < .0001 and p  = .0009 respectively). Percutaneous CS lead removal is successful by simple traction alone in the vast majority of cases. CS leads in place greater than 4 years, however, often require complex extraction. Specific extraction techniques can be implemented when simple traction is unsuccessful without an appreciable increase in complications.

BACKGROUND. Convalescent plasma is the only antibody-based therapy currently available for patients with coronavlrus disease 2019 (COVID-19). It has robust historical precedence and sound biological plausibility. Although promising, convalescent plasma has not yet been shown to be safe as a treatment for COVID-19. METHODS. Thus, we analyzed key safety metrics after transfusion of ABO-compatible human COVID-19 convalescent plasma in 5000 hospitalized adults with severe or life-threatening COVID-19, with 66% in the intensive care unit, as part of the US FDA expanded access program for COVID-19 convalescent plasma. RESULTS. The incidence of all serious adverse events (SAEs), including mortality rate (0.3%), in the first 4 hours after transfusion was <1%. Of the 36 reported SAEs, there were 25 reported incidences of related SAEs, including mortality (n = 4), transfusion-associated circulatory overload (n = 7), transfusion-related acute lung injury (n = 11), and severe allergic transfusion reactions (n = 3). However, only 2 of 36 SAEs were judged as definitely related to the convalescent plasma transfusion by the treating physician. The 7-day mortality rate was 14.9%. CONCLUSION. Given the deadly nature of COVID-19 and the large population of critically ill patients included in these analyses, the mortality rate does not appear excessive. These early indicators suggest that transfusion of convalescent plasma is safe in hospitalized patients with COVID-19. TRIAL REGISTRATION. ClinicalTrials.gov NCT04338360. FUNDING. Mayo Clinic, Biomedical Advanced Research and Development Authority (75A50120C00096), National Center for Advancing Translational Sciences (UL1TR002377), National Heart, Lung, and Blood Institute (5R35HL139854 and R01 HL059842), National Institute of Diabetes and Digestive and Kidney Diseases (5T32DK07352), Natural Sciences and Engineering Research Council of Canada (PDF-532926-2019), National Institute of Allergy and Infectious Disease (R21 AI145356, R21 AI152318, and AI152078), Schwab Charitable Fund, United Health Group, National Basketball Association, Millennium Pharmaceuticals, and Octapharma USA Inc.

To provide an update on key safety metrics after transfusion of convalescent plasma in hospitalized coronavirus 2019 (COVID-19) patients, having previously demonstrated safety in 5000 hospitalized patients. From April 3 to June 2, 2020, the US Food and Drug Administration Expanded Access Program for COVID-19 convalescent plasma transfused a convenience sample of 20,000 hospitalized patients with COVID-19 convalescent plasma. The incidence of all serious adverse events was low; these included transfusion reactions (n=78; <1%), thromboembolic or thrombotic events (n=113; <1%), and cardiac events (n=677, ~3%). Notably, the vast majority of the thromboembolic or thrombotic events (n=75) and cardiac events (n=597) were judged to be unrelated to the plasma transfusion per se. The 7-day mortality rate was 13.0% (12.5%, 13.4%), and was higher among more critically ill patients relative to less ill counterparts, including patients admitted to the intensive care unit versus those not admitted (15.6 vs 9.3%), mechanically ventilated versus not ventilated (18.3% vs 9.9%), and with septic shock or multiple organ dysfunction/failure versus those without dysfunction/failure (21.7% vs 11.5%). These updated data provide robust evidence that transfusion of convalescent plasma is safe in hospitalized patients with COVID-19, and support the notion that earlier administration of plasma within the clinical course of COVID-19 is more likely to reduce mortality.

The United States (US) Expanded Access Program (EAP) to coronavirus disease 2019 (COVID-19) convalescent plasma was initiated in response to the rapid spread of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the causative agent of COVID-19. While randomized clinical trials were in various stages of development and enrollment, there was an urgent need for widespread access to potential therapeutic agents. The objective of this study is to report on the demographic, geographical, and chronological characteristics of patients in the EAP, and key safety metrics following transfusion of COVID-19 convalescent plasma. Mayo Clinic served as the central institutional review board for all participating facilities, and any US physician could participate as a local physician-principal investigator. Eligible patients were hospitalized, were aged 18 years or older, and had-or were at risk of progression to-severe or life-threatening COVID-19; eligible patients were enrolled through the EAP central website. Blood collection facilities rapidly implemented programs to collect convalescent plasma for hospitalized patients with COVID-19. Demographic and clinical characteristics of all enrolled patients in the EAP were summarized. Temporal patterns in access to COVID-19 convalescent plasma were investigated by comparing daily and weekly changes in EAP enrollment in response to changes in infection rate at the state level. Geographical analyses on access to convalescent plasma included assessing EAP enrollment in all national hospital referral regions, as well as assessing enrollment in metropolitan areas and less populated areas that did not have access to COVID-19 clinical trials. From April 3 to August 23, 2020, 105,717 hospitalized patients with severe or life-threatening COVID-19 were enrolled in the EAP. The majority of patients were 60 years of age or older (57.8%), were male (58.4%), and had overweight or obesity (83.8%). There was substantial inclusion of minorities and underserved populations: 46.4% of patients were of a race other than white, and 37.2% of patients were of Hispanic ethnicity. Chronologically and geographically, increases in the number of both enrollments and transfusions in the EAP closely followed confirmed infections across all 50 states. Nearly all national hospital referral regions enrolled and transfused patients in the EAP, including both in metropolitan and in less populated areas. The incidence of serious adverse events was objectively low (<1%), and the overall crude 30-day mortality rate was 25.2% (95% CI, 25.0% to 25.5%). This registry study was limited by the observational and pragmatic study design that did not include a control or comparator group; thus, the data should not be used to infer definitive treatment effects. These results suggest that the EAP provided widespread access to COVID-19 convalescent plasma in all 50 states, including for underserved racial and ethnic minority populations. The study design of the EAP may serve as a model for future efforts when broad access to a treatment is needed in response to an emerging infectious disease. ClinicalTrials.gov NCT#: NCT04338360.

Purpose The purpose of this study is to describe the results of manual and automatic electronic medical record-based screening of patients at risk of sudden cardiac arrest (SCA) based on measurements of left ventricular ejection fraction (LVEF). Methods Counseling regarding SCA risk and implantable cardioverter defibrillator (ICD) therapy is underutilized in patients with reduced LVEF. We developed and implemented an electronic medical record (EMR)-based system for screening of such patients to improve care. In phase one, manual screening of electronic records and LVEF databases was initially performed by trained cardiac device nurses. In phase two, records were screened automatically by a customized program, and candidate patient records were sent to cardiac device nurses for final review and disposition. Results In phase one, 2,531 patients with LVEF ≤35% were identified over 398 days. Manual EMR review showed that 1,918 patients (76%) received appropriate counseling regarding SCA risk, received ICDs, or had disqualifying comorbidities. In phase two, 1,081 patients with LVEF ≤35% were identified after automatic screening of 44,672 echocardiograms and EMR over 251 days. Of these, 513 patients (58%) received appropriate counseling regarding SCA risk, received ICDs, or had disqualifying comorbidities. Conclusions These data detail the utilization of consultation regarding SCA risk and ICDs in patients with reduced LVEF at a tertiary care center with ready access to arrhythmia specialists. Notification of primary providers of reduced LVEF with recommendation for consultation was not effective in improving patient care.

Patients with implanted pacemakers and defibrillators are routinely cautioned regarding exposure to environmental magnetic fields because such exposure may interfere with device function. Previous reports have confirmed interference with bingo wands, stereo speakers, and various workplace sources. In the 4 patients in this report, we document inadvertent alteration of the tachyarrhythmia detection function of implantable cardioverter-defibrillators (ICDs) that occurred in health care settings because of deliberately applied magnetic fields. Three of these patients had pectorally implanted ICDs that may have been confused with pacemakers, and 2 patients had undergone office surgical procedures at which time a magnet had been applied over the device. These events stemmed from (1) potential confusion by health care workers about the nature of the implanted device and (2) unique features in a specific manufacturer's defibrillator. We recommend the following steps to avoid such problems: (1) when device programming hardware and trained personnel are readily available, the patient's device should be interrogated and reprogrammed before and after any procedure involving electrocautery; (2) patients with ICDs should be monitored during device inactivation because they are unprotected from potentially life-threatening arrhythmias during this period; and (3) if the clinical situation does not allow device interrogation and reprogramming, the patient should be monitored electrocardiographically during magnet application and the device interrogated as soon as possible after magnet removal.