Development of Ternary Amorphous Solid Dispersions Manufactured by Hot-Melt Extrusion and Spray-Drying─Comparison of In Vitro and In Vivo Performance.

Producing amorphous solid dispersions (ASDs) by hot-melt extrusion (HME) is favorable from an economic and ecological perspective but also limited to thermostable active pharmaceutical ingredients (APIs). A potential technology shift from spray-drying to hot-melt extrusion at later stages of drug product development is a desirable goal, however bearing the risk of insufficient comparability of the in vitro and in vivo performance of the final dosage form. Hot-melt extrusion was performed using API/polymer/surfactant mixtures with hydroxypropyl methylcellulose acetate succinate (HPMCAS) as the polymer and evaluated regarding the extrudability of binary and ternary amorphous solid dispersions (ASDs). Additionally, spray-dried ASDs were produced, and solid-state properties were compared to the melt-extruded ASDs. Tablets were manufactured of a ternary ASD lead candidate comparing their in vitro dissolution and in vivo performance. The extrudability of HPMCAS was improved by adding a surfactant as plasticizer, thereby lowering the high melt-viscosity. d-α-Tocopheryl polyethylene glycol succinate (TPGS) as surfactant showed the most similar solid-state properties between spray-dried and extruded ASDs compared to those of poloxamer 188 and sodium dodecyl sulfate. The addition of TPGS, however, barely affected API/polymer interactions. The in vitro dissolution experiment and in vivo dog study revealed a higher drug release of tablets manufactured from the spray-dried ASD compared to the melt-extruded ASD; this was attributed to the different particle size. We could further demonstrate that the drug release can be controlled by adjusting the particle size of melt-extruded ASDs leading to a similar release profile compared to tablets containing the spray-dried dispersion, which confirmed the feasibility of a technology shift from spray-drying to HME upon drug product development.

Probing the Molecular and Macroscopic Structure of Solid Solutions by Dynamic Nuclear Polarization (DNP) Enhanced 13C and 15N Solid-State NMR Spectroscopy.

Crystallization is a widely used purification technique in the manufacture of active pharmaceutical ingredients (APIs) and precursor molecules. However, when impurities and desired compounds have similar molecular structures, separation by crystallization may become challenging. In such cases, some impurities may form crystalline solid solutions with the desired product during recrystallization. Understanding the molecular structure of these recrystallized solid solutions is crucial to devise methods for effective purification. Unfortunately, there are limited analytical techniques that provide insights into the molecular structure or spatial distribution of impurities that are incorporated within recrystallized products. In this study, we investigated model solid solutions formed by recrystallizing salicylic acid (SA) in the presence of anthranilic acid (AA). These two molecules are known to form crystalline solid solutions due to their similar molecular structures. To overcome challenges associated with the long 1H longitudinal relaxation times (T1(1H)) of SA and AA, we employed dynamic nuclear polarization (DNP) and 15N isotope enrichment to enable solid-state NMR experiments. Results of solid-state NMR experiments and DFT calculations revealed that SA and AA are homogeneously alloyed as a solid solution. Heteronuclear correlation (HETCOR) experiments and plane-wave DFT structural models provide further evidence of the molecular-level interactions between SA and AA. This research provides valuable insights into the molecular structure of recrystallized solid solutions, contributing to the development of effective purification strategies and an understanding of the physicochemical properties of solid solutions.

Applying self-determination theory to stem medical schools' clinical teacher sustainability crisis.

THE PROBLEM: Medical schools require highly skilled and committed clinical faculty to teach, assess, supervise and mentor students' clinical care. Medical education is facing a crisis in recruiting and sustaining these clinical teachers. Faced with multiple demands and responsibilities in fast-paced clinical environments, teachers may not have the time, resources or stamina to sustain these critical roles. Medical school leaders must commit to and provide structures and processes to attract, sustain and retain clinical teachers. CONCEPTUAL FRAMEWORK: The authors use the lens of self-determination theory to frame approaches to support teacher sustainability. Self-determination theory describes sources of human motivation. The theory and its evidence base characterise three human psychological needs: autonomy, competence, and relatedness. This theory can bridge individual psychological and institutional leadership perspectives to help medical school leaders anticipate and respond to their clinical teachers' needs. The authors propose three practical steps: practices to advance employee-centredness, processes to align individual and institutional values, and restructuring education to support clinical teachers' needs alongside student and patient needs. The authors describe limitations to this relational approach that focuses on leadership actions and consider individual agency as another key factor for sustainability. DISCUSSION: Medical school leaders can develop and apply theory-driven approaches to advance sustainability. Sustainability now and in the future requires careful attention to the needs of clinical teachers and to their relationships with and within medical schools.

Facilitating Shared Decision Making Among Black Patients at Risk for Sudden Cardiac Arrest : A Randomized Clinical Trial.

BACKGROUND: Racial disparities in implantable cardioverter-defibrillator (ICD) implantation are multifactorial and are partly explained by higher refusal rates. OBJECTIVE: To assess the effectiveness of a video decision support tool for Black patients eligible for an ICD. DESIGN: Multicenter, randomized clinical trial conducted between September 2016 and April 2020. (ClinicalTrials.gov: NCT02819973). SETTING: Fourteen academic and community-based electrophysiology clinics in the United States. PARTICIPANTS: Black adults with heart failure who were eligible for a primary prevention ICD. INTERVENTION: An encounter-based video decision support tool or usual care. MEASUREMENTS: The primary outcome was the decision regarding ICD implantation. Additional outcomes included patient knowledge, decisional conflict, ICD implantation within 90 days, the effect of racial concordance on outcomes, and the time patients spent with clinicians. RESULTS: Of the 330 randomly assigned patients, 311 contributed data for the primary outcome. Among those randomly assigned to the video group, assent to ICD implantation was 58.6% compared with 59.4% in the usual care group (difference, -0.8 percentage point [95% CI, -13.2 to 11.1 percentage points]). Compared with usual care, participants in the video group had a higher mean knowledge score (difference, 0.7 [CI, 0.2 to 1.1]) and a similar decisional conflict score (difference, -2.6 [CI, -5.7 to 0.4]). The ICD implantation rate within 90 days was 65.7%, with no differences by intervention. Participants randomly assigned to the video group spent less time with their clinician than those in the usual care group (mean, 22.1 vs. 27.0 minutes; difference, -4.9 minutes [CI, -9.4 to -0.3 minutes]). Racial concordance between video and study participants did not affect study outcomes. LIMITATION: The Centers for Medicare & Medicaid Services implemented a requirement for shared decision making for ICD implantation during the study. CONCLUSION: A video-based decision support tool increased patient knowledge but did not increase assent to ICD implantation. PRIMARY FUNDING SOURCE: Patient-Centered Outcomes Research Institute.

Patient outcomes in a Longitudinal Integrated Clerkship: A systematic literature review.

CONTEXT: Patient-student relationships are at the heart of Longitudinal Integrated Clerkships (LICs). Outcomes for students and preceptors are beneficial, but patient outcomes remain unclear. This systematic literature review explored the current evidence base of patient outcomes in an LIC. Patient outcomes were defined as issues related to patient safety, clinical effectiveness or patient experience. METHODS: Seven bibliographic databases were searched. A wider search strategy included a hand search of three medical education journals' previous issues and backward/forward citation searching of included studies and of a relevant systematic review. Included studies were quality appraised and assessed for their strength and level of evidence. A qualitative data synthesis was performed. RESULTS: Databases searches identified 7237 titles. Following the removal of duplicates, titles and abstracts were reviewed against the inclusion criteria. Forty-eight studies had a full-text review. Nineteen met the inclusion criteria. Seven studies were included from the wider search strategy. From the 26 included studies, two major themes were identified. (1) 'A trusting patient-student relationship' contains the sub-themes: 'care and compassion', 'patient education and empowerment' and 'the loss of the student as 'my' doctor'. (2) 'The student acts as an agent of change for the patient' contains the sub-themes: 'patient advocacy', 'supporting the patient to navigate the healthcare system', 'communication between patient and healthcare professional' and 'enhancement of preceptors' care, healthcare services and communities'. CONCLUSIONS: LICs provide educational continuity allowing the creation of a trusting patient-student relationship. This relationship leads to students becoming agents of change for patients by enhancing patient outcomes. This review provides further evidence on the benefits of having an LIC as part of the medical education curricula and implications for its successful delivery. Further research is needed to explore educationally induced benefits for patients and look at objective assessments of patient health outcomes.

An exploratory study of goal orientations of traditional block and longitudinal integrated clerkship students.

BACKGROUND: Achievement goal theory links goal setting, motivation, and learning and describes three orientations: 'mastery' (seeking learning), 'performance' (seeking positive judgments), and 'performance-avoidance' (avoiding negative judgments). Mastery orientation is considered most adaptive. The authors investigated goal orientations of traditional block clerkship (TBC) and longitudinal integrated clerkship (LIC) students. METHODS: This was an exploratory study conducted at one US medical school. Three hundred and twenty students completed an anonymous survey consisting of three tools with validation evidence: Patterns of Adaptive Learning Survey, Task-choice Goal Measures, and Questionnaire Goal Choice Items. The authors analyzed the data using regression analyses, Chi-square, and Wilcoxon's rank-sum tests. RESULTS: While all students rated mastery items most highly on the five-point Likert scale (mean 4.58/5.00), LIC students rated performance-orientation lower (ß = -0.36, p = .04), chose personal mastery-orientation items more frequently (92% vs. 64.4%, p = .005), and perceived their learning environment as promoting less performance (ß = -0.60, p = .002) and performance-avoidance (ß = -0.78, p < .001) compared to TBC students. CONCLUSIONS: LIC and TBC students differed in their report of personal and clerkship goal orientations. These differences may inform educational design and future research to promote students' mastery orientation.

Psychological safety and accountability in longitudinal integrated clerkships: a dual institution qualitative study.

BACKGROUND: Psychological safety and accountability are frameworks to describe relationships in the workplace. Psychological safety is a shared belief by members of a team that it is safe to take interpersonal risks. Accountability refers to being challenged and expected to meet expectations and goals. Psychological safety and accountability are supported by relational trust. Relational continuity is the educational construct underpinning longitudinal integrated clerkships. The workplace constructs of psychological safety and accountability may offer lenses to understand students' educational experiences in longitudinal integrated clerkships. METHODS: We performed a qualitative study of 9 years of longitudinal integrated clerkship graduates from two regionally diverse programs-at Harvard Medical School and the University of North Carolina School of Medicine. We used deductive content analysis to characterize psychological safety and accountability from semi-structured interviews of longitudinal integrated clerkship graduates. RESULTS: Analysis of 20 graduates' interview transcripts reached saturation. We identified 109 discrete excerpts describing psychological safety, accountability, or both. Excerpts with high psychological safety described trusting relationships and safe learning spaces. Low psychological safety included fear and frustration and perceptions of stressful learning environments. Excerpts characterizing high accountability involved increased learning and responsibility toward patients. Low accountability included students not feeling challenged. Graduates' descriptions with both high psychological safety and high accountability characterized optimized learning and performance. CONCLUSIONS: This study used the workplace-based frameworks of psychological safety and accountability to explore qualitatively longitudinal integrated clerkship graduates' experiences as students. Graduates described high and low psychological safety and accountability. Graduates' descriptions of high psychological safety and accountability involved positive learning experiences and responsibility toward patients. The relational lenses of psychological safety and accountability may inform faculty development and future educational research in clinical medical education.

Faculty perspectives on facilitating medical students' longitudinal learning: A mixed-methods study.

INTRODUCTION: Medical students' longitudinal care of patients supports clinical learning and promotes patient-centredness. The literature presents little empirically derived guidance for faculty to facilitate students' longitudinal learning and care. Informed by the conceptual framework of relational learning, this study investigated faculty perspectives about longitudinal teaching, their strategies for facilitating students' longitudinal learning and perceived barriers and enablers. METHODS: Using a convergent mixed-methods approach at a single academic medical centre, the authors conducted a survey and two focus groups in 2018-2019 with faculty members teaching in three longitudinal clinical courses. Quantitative analyses included descriptive statistics and chi-square tests. Qualitative content analysis described deductive categories and identified inductive themes. RESULTS: Forty-three eligible faculty (69%) completed the survey. Ninety-one percent (n = 39) reported that teaching in a longitudinal model enhanced their experience as preceptors. Faculty described activities students performed to provide longitudinal care: spending time with patients independently (n = 38, 88%), making follow-up phone calls (n = 35; 81%) and participating in home- and community-based visits (n = 20, 47%), among others. Twelve faculty participated in two focus groups. Deductive analysis characterised strategies for facilitating students' longitudinal learning and barriers and enablers. Strategies included "encouraging students to follow patients," "faculty adaptability," "offering guidance and setting expectations," and "careful patient selection." Barriers included scheduling limitations, and enablers included student initiative. Inductive analysis identified two themes: faculty goals for students and faculty benefits from teaching. Goals included meaningful engagement with patients and their illness over time. Benefits from teaching included personal gratification, mentorship, and holistic student assessment. DISCUSSION: Our survey and focus group findings demonstrated positive faculty attitudes and experiences, characterised faculty goals and approaches, and identified elements of the educational context that hindered or facilitated longitudinal teaching and learning. This study's faculty perspectives build upon prior investigations of students' and patients' perspectives, offer teaching strategies, and may guide faculty development.

Hydrates of active pharmaceutical ingredients: A 35Cl and 2H solid-state NMR and DFT study.

This study uses 35Cl and 2H solid-state NMR (SSNMR) spectroscopy and dispersion-corrected plane-wave density functional theory (DFT) calculations to characterize the molecular-level structures and dynamics of hydrates of active pharmaceutical ingredients (APIs). We use 35Cl SSNMR to measure the EFG tensors of the chloride ions to characterize hydrated forms of hydrochloride salts of APIs, along with two corresponding anhydrous forms. DFT calculations are used to refine the crystal structures of the APIs and determine relationships between the 35Cl EFG tensors and the spatial arrangements of proximate hydrogen bonds, which are particularly influenced by interactions with water molecules. We find that the relationship between 35Cl EFG tensors and local hydrogen bonding geometries is complex, but meaningful structure/property relationships can be garnered through use of DFT calculations. Specifically, for every case in which such a comparison could be made, we find that the hydrate has a smaller magnitude of CQ than the corresponding anhydrous form, indicating a chloride ion environment with a ground-state electron density of higher spherical symmetry in the former. Finally, variable-temperature 35Cl and 2H SSNMR experiments on a deuterium-exchanged sample of the API cimetidine hydrochloride monohydrate are used to monitor temperature-dependent influences on the spectra that may arise from motional influences on the 35Cl and 2H EFG tensors. From the 2H SSNMR spectra, we determine that the motions of water molecules are characterized by jump-like motions about their C2 rotational axes that occur on timescales that are unlikely to influence the 35Cl central-transition (+1/2 ↔︎ -1/2) powder patterns (this is confirmed by 35Cl SSNMR). Together, these methods show great promise for the future study of APIs in their bulk and dosage forms, especially variable hydrates in which crystallographic water content varies with external conditions such as humidity.

Effects of ALS-associated TANK binding kinase 1 mutations on protein-protein interactions and kinase activity.

Exonic DNA sequence variants in the Tbk1 gene associate with both sporadic and familial amyotrophic lateral sclerosis (ALS). Here, we examine functional defects in 25 missense TBK1 mutations, focusing on kinase activity and protein-protein interactions. We identified kinase domain (KD) mutations that abolish kinase activity or display substrate-specific defects in specific pathways, such as innate immunity and autophagy. By contrast, mutations in the scaffold dimerization domain (SDD) of TBK1 can cause the loss of kinase activity due to structural disruption, despite an intact KD. Familial ALS mutations in ubiquitin-like domain (ULD) or SDD display defects in dimerization; however, a subset retains kinase activity. These observations indicate that TBK1 dimerization is not required for kinase activation. Rather, dimerization seems to increase protein stability and enables efficient kinase-substrate interactions. Our study revealed many aspects of TBK1 activities affected by ALS mutations, highlighting the complexity of disease pathogenicity and providing insights into TBK1 activation mechanism.

Coproducing clinical curricula in undergraduate medical education: Student and faculty experiences in longitudinal integrated clerkships.

PURPOSE: Educational coproduction, in which learners partner with educators to create and improve their educational experiences, can facilitate student-centered medical education. Empirical descriptions of best practices for involving students in clinical curricular coproduction are needed. We aimed to understand faculty and student perspectives on methods, perceived benefits, and common barriers and solutions to clinical curricular coproduction. METHODS: We conducted an international mixed-methods study of clinical curricular coproduction in undergraduate medical education and longitudinal integrated clerkships specifically. Faculty and students identified through an international listserv received an electronic survey to identify methods, benefits, and challenges of clinical curricular coproduction. We conducted semi-structured interviews with a subset of survey participants. We present descriptive statistics for survey data and themes derived from inductive qualitative analysis. RESULTS: Two hundred forty-seven individuals (104 faculty; 143 students) representing 52 medical schools in eight countries completed the survey. Methods for clinical curricular coproduction ranged from informal, low-intensity learner involvement (e.g. verbal feedback) to formal, high-intensity learner involvement (e.g. committee membership). Perceived benefits included improvements in student-faculty relationships, program culture and design, and student development. Structural issues (e.g. scheduling) were the most common perceived barriers. CONCLUSIONS: Clinical curricular coproduction among faculty and students is perceived to enhance collaboration, enable curriculum change, and support students' professional development. Our study offers empirical guidance for involving students as partners in clinical curricular coproduction.

Patient perceptions of students in a longitudinal integrated clerkship in Taiwan: a qualitative study.

BACKGROUND: Longitudinal integrated clerkships (LICs) are a model of clinical education growing rapidly in Western contexts. LICs use educational continuity to benefits students' clinical learning and professional identity formation. Patient-centered care is a core component of medical professionalism in the West. To support patient-centered care, education leaders in Taiwan restructured clinical education and implemented the first longitudinal integrated clerkship in East Asia. We aimed to investigate patients' perceptions of longitudinal relationships with the LIC students within Taiwan's Confucian cultural and social context. METHODS: We invited patients or their family members who were cared for longitudinally by a LIC student to participate in the study. Participating patients or their family members undertook semi-structured interviews. We analyzed data qualitatively using a general inductive approach to identify themes in the patients' descriptions of their experiences interacting with the LIC students. RESULTS: Twenty-five patients and family members participated in interviews: 16 patients and 9 family members. Qualitative analysis of interview transcripts identified three themes from patients' experience receiving care from their LIC students: care facilitation, companionship, and empathy. To provide care facilitation, LIC students served as a bridge between the physicians and patients. Students served patients by reminding, consulting, tracking disease progression, and researching solutions for problems. To provide companionship, students accompanied patients interpersonally like a friend or confidant who listens and provides a presence for patients. To provide empathy, patients reported that students showed sincere concern for patients' experience, feelings, and mood. CONCLUSION: In our study, Taiwanese patients' perspectives of LIC students suggested the value of care facilitation, companionship, and empathy. We discuss these themes within the context of Confucian culture and the Taiwanese context of care.

Rapid Characterization of Formulated Pharmaceuticals Using Fast MAS 1H Solid-State NMR Spectroscopy.

Active pharmaceutical ingredients (APIs) can be prepared in many different solid forms and phases that affect their physicochemical properties and suitability for oral dosage forms. The development and commercialization of dosage forms require analytical techniques that can determine and quantify the API phase in the final drug product. 13C solid-state NMR (SSNMR) spectroscopy is widely employed to characterize pure and formulated solid APIs; however, 13C SSNMR experiments on dosage forms with low API loading are often challenging due to low sensitivity and interference from excipients. Here, fast magic angle spinning 1H SSNMR experiments are shown to be applicable for the rapid characterization of low drug load formulations. Diagnostic 1H SSNMR spectra of APIs within tablets are obtained by using combinations of frequency-selective saturation and excitation pulses, two-dimensional experiments, and 1H spin diffusion periods. Selective saturation pulses efficiently suppress the broad 1H SSNMR signals from the most commonly encountered excipients such as lactose and cellulose, allowing observation of high-frequency API 1H NMR signals. 1H SSNMR provides a 1-3 orders of magnitude reduction in experiment time compared to standard 13C SSNMR experiments, enabling diagnostic SSNMR spectra of dilute APIs within tablets to be obtained within minutes. The 1H SSNMR spectra can be used for quantification, provided calibrations are performed on a standard sample with known API loading.

Diffusion of innovation and longitudinal integrated clerkships: Results of the clerkship directors in internal medicine annual survey.

PURPOSE: Longitudinal integrated clerkships (LICs) are innovative educational models that emphasize medical student continuity with patients, preceptors, peers, and health systems. We characterize LIC growth in the US and interpret the growth using Rogers' Diffusion of Innovation Theory. METHODS: In 2015, we surveyed 123 US allopathic medical schools affiliated with Clerkship Directors in Internal Medicine (CDIM). The organization's annual survey was supplemented with questions aimed to quantify the number of current and planned LICs and to determine the intended purpose of starting LICs. RESULTS: Of the 94 (out of 123 possible) schools which were responding, 35 (37%) have at least one LIC of six months or greater; of these 20 are year-long. Nineteen schools are engaged in planning a new LIC or increasing the number of students in an LIC. At least 45 (48%) responding schools will have LICs in future years. Respondents report implementing LICs to foster continuity of care, support patient-centeredness, advance inter-professional education, and address workforce shortages. CONCLUSIONS: The number of LICs is increasing across the US. We considered the data through the lens of Diffusion of Innovation Theory, speculated that LIC growth has reached "critical mass," and considered why the LIC innovation may be self-sustaining.

Quantifying Disproportionation in Pharmaceutical Formulations with 35Cl Solid-State NMR.

Reliable methods for the characterization of drug substances are critical for evaluating stability and bioavailability, especially in dosage formulations under varying storage conditions and usage. Such methods must also give information on the molecular identities and structures of drug substances and any potential byproducts of the formulation process, as well as providing a means of quantifying the relative amounts of these substances. For example, active pharmaceutical ingredients (APIs) are often formulated as ionic salts to improve the pharmaceutical properties of dosage forms; however, exposure of such formulations to elevated temperature and/or humidity can trigger the conversion of an ionic salt of an API to a neutral form with different properties, through a process known as disproportionation. It is particularly challenging to identify changes of pharmaceutical components in solid dosage formulations, which are complex heterogeneous mixtures of the API and excipient components (e.g., binders, disintegrants, and lubricants). In this study, we illustrate that ultra-wideline (UW) 35Cl solid-state NMR (SSNMR) can be used to characterize the disproportionation reaction of pioglitazone HCl (PiogHCl) in mixtures with metallic stearate excipients. 35Cl SSNMR can quantitatively detect the amount of PiogHCl in mixed samples within ±1 wt % and measure the degree of PiogHCl disproportionation in formulation samples stressed at high relative humidity and temperature. Unlike other methods used for characterizing disproportionation, our experiments directly probe the Cl- anions in both the intact salt and disproportionation products, revealing all of the chlorine-containing products in the solid-state chemical reaction without interfering signals from the formulation excipients.

Findings from the Harvard Medical School Cambridge Integrated Clerkship, a Year-Long Longitudinal Psychiatry Experience.

OBJECTIVE: The Harvard Medical School Cambridge Integrated Clerkship is a longitudinal integrated clerkship that has provided an alternative clinical model for medical education in psychiatry since its inception in 2004. This study was undertaken in an effort to better understand the student experience of the Cambridge Integrated Clerkship and how it may have impacted students' perceptions of and interest in psychiatry, as well as performance. METHODS: Qualitative surveys were sent via e-mail to the first 11 student cohorts who had completed the Cambridge Integrated Clerkship (from 2004 to 2014) and for whom we had e-mail addresses (N = 100), and the free-text responses were coded thematically. All available standardized scoring data and residency match data for Cambridge Integrated Clerkship graduates were obtained. RESULTS: From 2006 to 2014, 12 out of 73 Cambridge Integrated Clerkship students who entered the match chose a psychiatry residency (16.4%), four times more than students in traditional clerkships at Harvard Medical School (3.8% of 1355 students) or the national average (4.1% of 146,066 US applicants). Thirty of the 100 surveyed Cambridge Integrated Clerkship graduates (30%) responded to the qualitative survey with free-text remarks on a number of themes. CONCLUSIONS: Cambridge Integrated Clerkship students compared positively to their classmates in terms of standardized test performance. Their fourfold higher match rate into psychiatry compared to other students raises intriguing questions as to what role a longitudinal clerkship might have played in developing interest in psychiatry as a career.

Clinical Performance of Magnetic Resonance Imaging Conditional and Nonconditional Cardiac Implantable Electronic Devices.

OBJECTIVES: This study compared risks associated with magnetic resonance imaging (MRI) in patients with non-MRI conditional and MRI conditional pacing and defibrillator systems with particular attention to clinically actionable outcomes. BACKGROUND: While recipients of new MRI conditional pacemaker and defibrillator systems may undergo MRI scanning with very low risk, safety and regulatory concerns persist regarding such scanning in recipients of non-MRI conditional systems. METHODS: Patients with any cardiac device who were referred for MRI were prospectively enrolled at a single center and underwent scanning at 1.5 Tesla. Pre- and postscan lead characteristic changes, system integrity, and symptoms were analyzed. A comparison was made between non-MRI conditional and MRI conditional devices. RESULTS: 105 patients were evaluated allowing for comparison of 97 scans with non-MRI conditional devices and 16 scans with MRI conditional devices. The cohort included those with pacemaker dependency, defibrillator, and cardiac resynchronization devices. Small, nonsignificant changes were observed in lead characteristics following scanning, and there was no significant difference when comparing non-MRI and MRI conditional devices. Lead parameter changes did not require lead revision or programming changes. No device reset, failures, or premature scan termination was observed. CONCLUSIONS: 1.5 T MRI scanning in patients with MRI conditional and non-MRI conditional cardiac devices was performed with similar, low clinical risk.