Publications by authors named "Michael J Mirro"

Synchronized diaphragmatic stimulation (SDS) is a novel extra-cardiac device-based therapy for symptomatic heart failure with reduced ejection fraction. SDS provides imperceptible chronic stimulation of the diaphragm through a laparoscopically implanted system consisting of an implantable pulse generator and two sensing/stimulating leads affixed to the inferior surface of the diaphragm delivering imperceptible R-wave gaited pulses that alter intrathoracic pressure improving ventricular filling and cardiac output. We describe, in a man with a history of myocardial infarctions resulting in heart failure and persistent New York Heart Association Class III symptoms despite standard therapies, the successful implantation of SDS resulting in improved quality of life, N-terminal pro brain natriuretic peptide, cardiac function, and exercise tolerance through 12 months of follow-up.

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Background: Traditionally, implantation of the subcutaneous implantable cardioverter defibrillator (S-ICD) requires incisions near the lateral chest wall, the xyphoid, and the superior sternal region (three-incision technique [3IT]). A two-incision technique (2IT) avoids the superior incision and has been shown to be a viable alternative in small studies with limited follow-up.

Objectives: To report on the long-term safety and efficacy of the 2IT compared to the 3IT procedure in a large patient cohort.

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Background: Every day, older adults living with heart failure make decisions regarding their health that may ultimately affect their disease trajectory. Experts describe these decisions as instances of naturalistic decision making influenced by the surrounding social and physical environment and involving shifting goals, high stakes, and the involvement of others.

Objective: This study applied a naturalistic decision-making approach to better understand everyday decision making by older adults with heart failure.

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Objective: Our primary objectives were to examine adherence rates across two technologies (e-prescribing software and smart pill bottle) with cross-validation from alert-triggered messaging within the patient electronic health record (EHR) portal and to explore the benefits and challenges faced by atrial fibrillation (AF) patients in using a smart pill bottle.

Materials And Methods: We triangulated the rate of oral anticoagulant medication adherence among 160 AF patients over 6 months using an EHR in combination with data from the AdhereTech© Wireless Smart Pill Bottle and Surescripts. In addition, we collected qualitative feedback on patients' Smart Pill Bottle usage through structured interviews with 153 participants.

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Background: User-centered design (UCD) is a powerful framework for creating useful, easy-to-use, and satisfying mobile health (mHealth) apps. However, the literature seldom reports the practical challenges of implementing UCD, particularly in the field of mHealth.

Objective: This study aims to characterize the practical challenges encountered and propose strategies when implementing UCD for mHealth.

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Aims: To identify knowledge gaps and preferences for educational material to improve nurse-patient communication and self-care.

Design: Using a mixed-methods design, we conducted focus groups and quantitative surveys.

Methods: We conducted three focus groups with atrial fibrillation (AF) patients and support persons ( = 17 participants; 66 ± 16 years) at critical treatment junctures (recent diagnosis or medication switch).

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Personas can be used to understand patterns of variation in patients' performance of cognitive work, particularly self-care decision making. In this study, we used a patient-centered cognitive task analysis (P-CTA) to develop self-care decision-making personas. We collected data from 24 older adults with chronic heart failure and 14 support persons, using critical incident and fictitious scenario interviews.

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Objective: Researchers conduct studies with selection biases, which may limit generalizability and outcomes of intervention research. In this methodological reflection, we examined demographic and health characteristics of implantable cardioverter defibrillator patients who were excluded from an informatics intervention due to lack of access to a computer and/or the internet.

Materials And Methods: Using information gathered from surveys and electronic health records, we compared the intervention group to excluded patients on demographic factors, computer skills, patient activation, and medical history.

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Guidelines for the treatment of heart failure (HF) recommend the titration of β blockers (BB) to a target dosage shown to be effective in clinical trials. The benefit of BBs is associated with heart rate (HR) control, with a target resting HR <70 bpm which in clinical trials have been associated with improved clinical outcomes. The primary purpose of this study was to gauge the ability to achieve guideline-directed medical therapy HR control in the early posthospitalization period for HF patients with the wearable cardioverter defibrillator (WCD), assessing whether the WCD could be used to evaluate HR both at rest and during activity to determine if targets were being met and to adequately direct clinical decision making.

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Background: Guideline-directed medical therapy (GDMT) for patients with heart failure with reduced ejection fraction (HFrEF) has been challenging to achieve universally. Healthcare providers who seek to achieve optimal medical therapy frequently consider either a wearable cardioverter defibrillator (WCD) or an implantable cardioverter defibrillator (ICD) as indicated. The dynamic process of communication and physician recommendations marks a setting to study the relative interdependence of medical therapies and best practice.

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Article Synopsis
  • - Patients with implantable cardioverter defibrillators (ICDs) benefit from remote monitoring, which allows quicker responses to heart rhythm events; however, they currently don’t have access to their own ICD data.
  • - A study explored delivering ICD data to patients via a personal health record (PHR) to enhance their engagement and understanding of their heart health, using interviews with 21 patients over three months.
  • - Key findings showed that patients want reassuring, clear, and relevant information about their ICD data; effective sharing of this information requires context and customization to meet individual needs.
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Embolic stroke is a major complication of atrial fibrillation (AF) that frequently results in disability or death. The administration of oral anticoagulation can reduce stroke risk in AF patients; however, medication non-adherence can eliminate this benefit. To date, reported patient adherence rates to oral anticoagulation regimens vary.

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Objectives: To determine the impact of tethered personal health record (PHR) use on patient engagement and intermediate health outcomes among patients with coronary artery disease (CAD).

Methods: Adult CAD patients (N = 200) were enrolled in this prospective, quasi-experimental observational study. Each patient received a PHR account and training on its use.

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Approximately half of patients with atrial fibrillation and with risk factors for stroke are not treated with oral anticoagulation (OAC), whether it be with vitamin K antagonists (VKAs) or novel OACs (NOACs); and of those treated, many discontinue treatment. Leaders from academia, government, industry, and professional societies convened in Washington, DC, on December 3-4, 2012, to identify barriers to optimal OAC use and adherence and to generate potential solutions. Participants identified a broad range of barriers, including knowledge gaps about stroke risk and the relative risks and benefits of anticoagulant therapies; lack of awareness regarding the potential use of NOAC agents for VKA-unsuitable patients; lack of recognition of expanded eligibility for OAC; lack of availability of reversal agents and the difficulty of anticoagulant effect monitoring for the NOACs; concerns with the bleeding risk of anticoagulant therapy, especially with the NOACs and particularly in the setting of dual antiplatelet therapy; suboptimal time in therapeutic range for VKA; and costs and insurance coverage.

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Objectives: To better inform patients and physicians of the expected risk of adverse events and to assist hospitals' efforts to improve the outcomes of patients undergoing implantable cardioverter-defibrillator (ICD) implantation, we developed and validated a risk model using data from the NCDR (National Cardiovascular Data Registry) ICD Registry.

Background: ICD prolong life in selected patients, but ICD implantation carries the risk of periprocedural complications.

Methods: We analyzed data from 240,632 ICD implantation procedures between April 1, 2010, and December 31, 2011 in the registry.

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Sudden cardiac arrest (SCA) is one of the most impactful public health problems in the United States. Despite the progress made in reducing the number of cardiac deaths, the incidence of sudden cardiac death remains high. Studies of life-saving interventions for prevention and treatment of SCA, like β-blockers, aldosterone antagonists, implantable cardioverter defibrillator therapy, automated external defibrillators, and cardiopulmonary resuscitation, have brought to light substantial underutilization, variations in care, and disparities.

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Objectives: The National Cardiovascular Data Registry (NCDR) developed the Data Quality Program to meet the objectives of ensuring the completeness, consistency, and accuracy of data submitted to the observational clinical registries. The Data Quality Program consists of 3 main components: 1) a data quality report; 2) a set of internal quality assurance protocols; and 3) a yearly data audit program.

Background: Since its inception in 1997, the NCDR has been the basis for the development of performance and quality metrics, site-level quality improvement programs, and peer-reviewed health outcomes research.

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