Fully magnetically centrifugal left ventricular assist device and long-term outcomes: the ELEVATE registry.

BACKGROUND AND AIMS: HeartMate 3 (HM3) is a fully magnetically levitated continuous flow left ventricular assist device, which received CE marking in 2015. The ELEVATE Registry was initiated to collect real-world outcomes in patients treated with HM3 post-CE Mark approval. METHODS: A total of 540 subjects implanted at 26 centres between March 2015 and February 2017 were included in this registry. Of these, 463 received the device as a primary implant (primary implant cohort, PIC), 19 as a pump exchange (pump exchange cohort), and in 58 patients, only anonymized survival data were collected (anonymized cohort, AC). Patients in the PIC contributed to the baseline demographics, survival, adverse events, quality of life (QoL) (EuroQoL-5 Dimensions-5 Levels visual analogue scale), and functional capacity (6 min walk distance) assessments, while patients in the AC contributed only to survival. RESULTS: Primary implant cohort patients had a mean age of 56 years and were predominantly male (89%) with 48% ischaemic aetiology. The majority of subjects was designated bridge to transplant (66%) and had INTERMACS Profiles 1-3 (70%). At baseline, the subjects had poor functional capacity (104 ± 140 m) and impaired QoL (35 ± 19 points). The overall survival rate of the PIC was 63.3% and survival free of stroke was 58.1% at 5 years. Significant improvements in functional capacity and QoL were observed and maintained for 5 years (301 ± 131 m and 64 ± 20 points, respectively). CONCLUSIONS: Real-world data from the ELEVATE registry demonstrate an overall survival rate for primary implants of 63.3%. In the PIC, reductions in adverse events for patients in the extended follow-up and improved QoL and functional capacity were observed at 5 years in this patient population with advanced heart failure.

Predictors of 5-Year Mortality in Patients Managed With a Magnetically Levitated Left Ventricular Assist Device.

BACKGROUND: In advanced heart failure patients implanted with a fully magnetically levitated HeartMate 3 (HM3, Abbott) left ventricular assist device (LVAD), it is unknown how preimplant factors and postimplant index hospitalization events influence 5-year mortality in those able to be discharged. OBJECTIVES: The goal was to identify risk predictors of mortality through 5 years among HM3 LVAD recipients conditional on discharge from index hospitalization in the MOMENTUM 3 pivotal trial. METHODS: This analysis evaluated 485 of 515 (94%) patients discharged after implantation of the HM3 LVAD. Preimplant (baseline), implant surgery, and index hospitalization characteristics were analyzed individually, and as multivariable predictors for mortality risk through 5 years. RESULTS: Cumulative 5-year mortality in the cohort (median age: 62 years, 80% male, 65% White, 61% destination therapy due to transplant ineligibility) was 38%. Two preimplant characteristics (elevated blood urea nitrogen and prior coronary artery bypass graft or valve procedure) and 3 postimplant characteristics (hemocompatibility-related adverse events, ventricular arrhythmias, and estimated glomerular filtration rate <60 mL/min/1.73 m2 at discharge) were predictors of 5-year mortality. In 171 of 485 patients (35.3%) without any risk predictors, 5-year mortality was reduced to 22.6% (95% CI: 15.4%-32.7%). Even among those with 1 or more predictors, mortality was <50% at 5 years (45.7% [95% CI: 39.0%-52.8%]). CONCLUSIONS: Long-term survival in successfully discharged HM3 LVAD recipients is largely influenced by clinical events experienced during the index surgical hospitalization in tandem with baseline factors, with mortality of <50% at 5 years. In patients without identified predictors of risk, long-term 5-year mortality is low and rivals that achieved with heart transplantation, even though most were implanted with destination therapy intent. (MOMENTUM 3 IDE Clinical Study Protocol, NCT02224755; MOMENTUM 3 Pivotal Cohort Extended Follow-up PAS, NCT03982979).

Incidence and clinical correlates of de-novo aortic regurgitation with a fully magnetically levitated left ventricular assist device: a MOMENTUM 3 trial portfolio analysis.

AIMS: We assessed the incidence, predictors and clinical correlates of de-novo aortic regurgitation (AR), which physiologically reduces left ventricular assist device (LVAD) effectiveness due to recirculation syndrome, in the MOMENTUM 3 trial portfolio of the fully magnetically levitated HeartMate 3 (HM3) pump using the randomized pivotal trial (PT) and post-trial continued access protocol (CAP). METHODS AND RESULTS: De-novo aortic regurgitation incidence at 2 years was analysed in the randomized PT and validated in the first 1000 implanted patients of the CAP. Patients with concomitant/prior aortic valve surgery or without baseline or post-implant echocardiograms were excluded from this analysis. AR severity was assessed qualitatively by site-adjudicated echocardiograms (significant AR was defined as moderate or severe grade on echocardiogram). Of 1028 patients enrolled in the PT, 918 were eligible for inclusion in this analysis (HM3, n = 465; HMII, n = 453). At 2 years of LVAD support, freedom from significant AR was greater in the HM3 (92%) than HMII (82%) (hazard ratio 0.45, 95% confidence interval 0.27-0.75, p < 0.01). Of 907 HM3 patients analysed from the first 1000 implanted CAP patients, the rate of freedom from significant AR was 90%, consistent with the PT (p = 0.3). In the combined HM3 group (n = 1372), multivariable Cox modelling identified increasing age and female sex as significant predictors. Survival free of urgent transplant or AR corrective procedure was similar between HM3 patients with and without significant de-novo AR. CONCLUSIONS: The development of moderate or severe grade de-novo AR is reduced with the fully magnetically levitated HM3 LVAD compared to the axial-flow HMII pump. The occurrence of significant de-novo AR with the HM3 pump is not associated with a worse outcome at 2 years of follow-up.

Factors Associated With Optimal Follow-up in Women With BI-RADS 3 Breast Findings.

OBJECTIVE: Assess rate of and factors associated with optimal follow-up in patients with BI-RADS 3 breast findings. METHODS: This Institutional Review Board-approved, retrospective cohort study, performed at an academic medical center, included all women undergoing breast imaging (ultrasound and mammography) in 2016. Index reports for unique patients with an assessment of BI-RADS 3 (retrieved via natural language processing) comprised the study population. Patient-specific and provider-related features were extracted from the Research Data Warehouse. The Institutional Cancer Registry identified patients diagnosed with breast cancer. Optimal follow-up rate was calculated as patients with follow-up imaging on the same breast 3 to 9 months from the index examination among patients with BI-RADS 3 assessments. Univariate analysis and multivariable logistic regression determined features associated with optimal follow-up. Malignancy rate and time to malignancy detection were recorded. RESULTS: Among 93,685 breast imaging examinations, 64,771 were from unique patients of which 2,967 had BI-RADS 3 findings (4.6%). Excluding patients with off-site index examinations and those with another breast examination <3 months from the index, 1,125 of 1,511 patients (74%) had optimal follow-up. In univariate and multivariable analysis, prior breast cancer was associated with optimal follow-up; younger age, Hispanic ethnicity, divorced status, and lack of insurance were associated with not having optimal follow-up. Malignancy rate was 0.86%, and mean time to detection was 330 days. DISCUSSION: Follow-up of BI-RADS 3 breast imaging findings is optimal in only 74% of women. Further interventions to promote follow-up should target younger, unmarried women, those with Hispanic ethnicity, and women without history of breast cancer and without insurance coverage.

Comparing Tumor Characteristics and Rates of Breast Cancers Detected by Screening Digital Breast Tomosynthesis and Full-Field Digital Mammography.

OBJECTIVE. The purpose of this study was to compare the cancer detection rates (CDRs), tumor types, and characteristics between screening digital breast tomosynthesis (DBT) and screening full-field digital mammography (FFDM) in a matched patient population in a large academic breast imaging practice with mixed DBT and FFDM technology. MATERIALS AND METHODS. In this retrospective study, we reviewed consecutive screening FFDM and DBT examinations performed between October 2012 and September 2014. To control for nonrandomized selection of FFDM versus DBT examinations, we applied propensity score matching on the basis of patient age, imaging site, and prior imaging findings. An institutional breast cancer registry identified cancer diagnoses. CDR and tumor type, grade, receptor, nodal status, and size were compared between matched FFDM and DBT groups. RESULTS. Sixty-one cancers were detected in the matched screening cohort of DBT (n = 9817) and FFDM (n = 14,180) examinations. CDR was higher with DBT than with FFDM for invasive cancers (2.8 vs 1.3, p = 0.01), minimal cancers (2.4 vs 1.2, p = 0.03), estrogen receptor-positive invasive cancers (2.6 vs 1.1, p = 0.01), and node-negative invasive cancers (2.3 vs 1.1, p = 0.02.), respectively. The ratio of screen-detected invasive cancers to ductal carcinoma in situ on DBT (3.0) was not significantly different from that on FFDM (2.6) (p = 0.79). CONCLUSION. DBT results in an overall increase in CDR irrespective of the tumor type, size, or grade of cancer.

Conspicuity of Screen-Detected Malignancies on Full Field Digital Mammography vs. Synthetic Mammography.

RATIONALE AND OBJECTIVES: To evaluate conspicuity of screen-detected cancers on two-dimensional synthetic mammography (SM) reconstructed from digital breast tomosynthesis (DBT) compared to two-dimensional full field digital mammography (FFDM). MATERIALS AND METHODS: IRB-approved retrospective review of consecutive screen-detected cancers from October 1, 2015 to June 30, 2017 was performed. All examinations were reviewed by three radiologists in consensus (n = 224); a score of 1-3 was given to each screen-detected cancer on SM vs. FFDM [1 = FFDM more conspicuous than SM, 2 = FFDM equivalent to SM, and 3 = SM more conspicuous than FFDM]. Findings considered only visible on tomosynthesis (n = 40), without medical history (n = 2), and with skin thickening only (n = 1) were excluded, leaving 181 cases as the study population. The longitudinal medical record was reviewed to determine patient demographics and outcomes of imaging surveillance and biopsy. RESULTS: Mammographic features on SM (n = 181) were calcifications (n = 68, 37.8%), masses (n = 51, 27.8%), asymmetries (n = 50, 27.6% [11 focal asymmetries]), and distortion (n = 12, 6.8%). The majority (76%, 137/181) of findings were equal or more conspicuous on SM vs. FFDM. However, calcifications and distortion greater than 2 cm were more conspicuous on SM and asymmetries were less conspicuous on SM vs. FFDM, controlling for menopausal status, family or personal history of breast cancer, BRCA status, and breast density. CONCLUSION: Although the majority of screen-detected cancers are equal to more conspicuous on SM when compared to FFDM, calcifications and asymmetries <2cm were less conspicuous on SM than FFDM. When SM + DBT is used as an alternative to FFDM + DBT in breast cancer screening, caution should be taken when assessing one-view asymmetries and findings <2cm on SM.

Impact of an Information Technology-Enabled Quality Improvement Initiative on Timeliness of Patient Contact and Scheduling of Screening Mammography Recall.

OBJECTIVE. The purpose of this study was to evaluate the impact of an information technology-enabled quality improvement initiative on timeliness of patient contact and scheduling of screening mammography recall. MATERIALS AND METHODS. The study was conducted in a screening practice (two ambulatory centers, A and B; two hospitals, C and D) that uses offline batch results (A, B, C) and same-day results (D) with on-site (A, C, D) or off-site (B) coordinators scheduling recalls. Before the intervention, radiologists at sites A, B, and C conveyed recalls via paper lists to coordinators after batch interpretation. At site D, coordinators received recall lists several times a day. In March 2017 an electronic alert system was implemented to notify coordinators of recall at report signing with required closed-loop acknowledgment once recall was scheduled. Mean time (hours, excluding weekends) to schedule diagnostic evaluation was compared for 4-month periods before and after intervention by two-tailed t test and statistical process control analyses. RESULTS. Recall rates were 9.5% (1356/14,315) before and 8.9% (1432/16,034) after the intervention (p = 0.10). Mean time to schedule screening decreased after the intervention as follows: site A from 86 to 65 hours (-24.4%, p = 0.01); site B, 116 to 70 hours (-39.7%, p < 0.0001); site C, 98 to 65 hours (-33.7%, p = 0.002); and site D, 49 to 42 hours (-14.3%, p = 0.21). Statistical process control analysis showed significant sustained improvements at sites A, B, and C in mean time to patient contact and scheduling of diagnostic evaluation. CONCLUSION. An information technology-enabled quality improvement initiative to notify coordinators of screening recalls in real time with required patient contact and scheduling acknowledgment reduced time to diagnostic scheduling in a multisite practice. The greatest impact was found at the site with off-site coordinators, the least at the site performing same-day interpretation.

Impact of a Multifaceted Information Technology-Enabled Intervention on the Adoption of ACR White Paper Follow-Up Recommendations for Incidental Adnexal Lesions Detected on CT.

OBJECTIVE. The objective of our study was to improve adherence to American College of Radiology (ACR) white paper follow-up imaging recommendations for incidental adnexal lesions seen on pelvic CT (herein referred to as "adherence rate to recommendations"). MATERIALS AND METHODS. This quality improvement project was conducted at a large academic teaching hospital. The baseline adherence rate to recommendations was assessed by screening all pelvic CT reports for the period from October 22, 2016, through December 22, 2016, for incidental adnexal findings, followed by manual review. Forty abdominal and cancer imaging radiologists were surveyed to understand the barriers to adoption of the recommendations. Interventions to address the most common identified barriers were implemented on December 23, 2016. The postintervention adherence rate was assessed from December 23, 2016, through February 15, 2017, by again screening CT pelvis reports for incidental adnexal lesions followed by manual review. The change in pre- and postintervention adherence rates was assessed using the Fisher exact test and statistical process control (SPC) p-chart with 3-sigma control limits. RESULTS. The adherence rate to recommendations at baseline was 67% (121/181). Of the 28 of 40 (70%) radiologists who completed the survey, only 29% (8/28) often or consistently used the recommendations. Not remembering the details of the recommendations or not having time to look them up accounted for 83.3% of the barriers cited by radiologists. Interventions consisted of radiologist education and creation of an easily accessible clinical decision support tool incorporated into radiology reporting workflow. The adherence rate to recommendations after the intervention increased to 87% (129/148; p < 0.0001), as also shown by the SPC chart. CONCLUSION. The rate of adherence to follow-up imaging recommendations significantly increased after radiologist education and incorporation of recommendations into the radiologist workflow.

Multivariate Analysis of Radiologists' Usage of Phrases that Convey Diagnostic Certainty.

RATIONALE AND OBJECTIVES: To quantify the use of Diagnostic Certainty Phrases (DCP) in radiology reports, including DCPs with good agreement (including "diagnostic of," "unlikely" and "represents") in connoting degree of certainty between providers based on previous studies; and to assess whether modality, presence of a trainee, radiologic subspecialty, and individual radiologists are associated with the usage of DCPs with good agreement. MATERIALS AND METHODS: This retrospective, IRB-approved study was conducted at an academic medical center. Radiology reports that contain DCPs were identified using information retrieval from all reports generated in 2016, excluding mammograms, obstetrical ultrasound, bone densitometry, and interventional studies. DCPs connoting good agreement were further noted. Of the reports that contained DCPs, a two-level hierarchical generalized linear model with attending as the level-two variable was performed comparing the use of DCP with good agreement while considering trainee involvement, modality, and subspecialty. RESULTS: A total of 159,151 reports out of 370,881 were found to have at least one DCP (43%). Reports of CT scans had the most number of DCP (68% of all CT reports). Breast and abdomen subspecialties were associated with use of DCP with good agreement. There was significant variation in use of DCP with good agreement between physicians that could not be explained by modality, trainee presence, and subspecialty. CONCLUSION: Phrases to convey diagnostic certainty were commonly used in radiology reports. There is wide variation in usage of DCP with good agreement. Future interventions to reduce variation in use of DCPs may reduce ambiguity and improve quality of radiology reports.

Patient, Radiologist, and Examination Characteristics Affecting Screening Mammography Recall Rates in a Large Academic Practice.

OBJECTIVE: The aims of this study were to evaluate patient, radiologist, and examination characteristics affecting screening mammography recall rates in an academic breast imaging practice and to identify modifiable factors that could reduce recall variation. METHODS: This institutional review board-approved retrospective study included screening mammographic examinations in female patients interpreted by 13 breast imaging specialists at an academic center and two outpatient centers from October 1, 2012, to May 31, 2015. Patient demographics were extracted via electronic medical record. Natural language processing captured breast density, BI-RADS assignment, and current and prior screening examination findings. Radiologists' annual screening volumes, clinical experience, and concentration in breast imaging were calculated. Risk aversion, stress from uncertainty, and malpractice concerns were derived via survey. Univariate and multivariate analyses assessed patient, radiologist, and examination characteristics associated with likelihood of mammography recall. The Pearson product-moment correlation coefficient was used to assess the relationship between cancer detection rate and recall rate. RESULTS: Overall, 5,678 of 61,198 screening examinations (9.3%) were recalled. In multivariate analysis, patient and radiologist characteristics associated with higher odds of recall included patient's age < 50 years (P < .0001), prior mammographic findings (calcification [P < .0001], mass [P < .0001], higher density category [P < .0001]), baseline examination (P < .0001), annual reading volume < 1,250 examinations (P = .0282), and <10 years of experience (P = .0036). Radiologist's risk aversion, stress from uncertainty, malpractice concerns, and cancer detection rates were not associated with higher recall rates (r = -0.36, P = .23). CONCLUSIONS: In addition to patient and examination factors, screening recall variations were associated with radiologists' annual reading volume and experience. Interventions targeting radiologist factors (screening volumes, second review of potential recalls) may help reduce unwarranted variation in screening recall.

Integrity of clinical information in computerized order requisitions for diagnostic imaging.

Objective: Assess information integrity (concordance and completeness of documented exam indications from the electronic health record [EHR] imaging order requisition, compared to EHR provider notes), and assess potential impact of indication inaccuracies on exam planning and interpretation. Methods: This retrospective study, approved by the Institutional Review Board, was conducted at a tertiary academic medical center. There were 139 MRI lumbar spine (LS-MRI) and 176 CT abdomen/pelvis orders performed 4/1/2016-5/31/2016 randomly selected and reviewed by 4 radiologists for concordance and completeness of relevant exam indications in order requisitions compared to provider notes, and potential impact of indication inaccuracies on exam planning and interpretation. Forty each LS-MRI and CT abdomen/pelvis were re-reviewed to assess kappa agreement. Results: Requisition indications were more likely to be incomplete (256/315, 81%) than discordant (133/315, 42%) compared to provider notes (p < 0.0001). Potential impact of discrepancy between clinical information in requisitions and provider notes was higher for radiologist's interpretation than for exam planning (135/315, 43%, vs 25/315, 8%, p < 0.0001). Agreement among radiologists for concordance, completeness, and potential impact was moderate to strong (Kappa 0.66-0.89). Indications in EHR order requisitions are frequently incomplete or discordant compared to physician notes, potentially impacting imaging exam planning, interpretation and accurate diagnosis. Such inaccuracies could also diminish the relevance of clinical decision support alerts if based on information in order requisitions. Conclusions: Improved availability of relevant documented clinical information within EHR imaging requisition is necessary for optimal exam planning and interpretation.