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102 citation(s) found for "Cullen, L".

Abstract 9243: Comparison of the 2006 and 2010 Appropriate Use Criteria for CT Coronary Angiography in an Academic Medical Center
Cullen, Ethany L., Aggarwal, Shivani , Goss, Brian C., Araoz, Philip A. , Gibbons, Raymond J.

Circulation | April 23, 2024 | Volume: 124 | Issue: suppl_21 | Pages: No page available

10.1161/circ.124.suppl_21.a9243 Get It

Purpose: We previously analyzed the 2006 appropriateness criteria for cardiac computed tomography (CT) and found 42% of our patients were not classifiable, suggesting the criteria were difficult to apply clinically. These criteria were revised in 2010. The purpose of our study is to compare the new 2010 appropriate use criteria to the original 2006 criteria to determine if the 2010 criteria were more applicable. Materials and Methods: In a previous study we applied the 2006 appropriateness criteria to 251 patients that underwent cardiac CT from June 1 to December 31, 2007. Each patient was assigned an indication from the 2006 appropriate use criteria by two observers, classifying patients as appropriate, inappropriate, uncertain, or nonclassifiable. A third observer settled disagreements. This process was applied to the same 251 patients using the 2010 criteria. The data from the previous study using the 2006 criteria was compared to the data obtained using the 2010 criteria to determine changes in the number of nonclassifiable, appropriate, inappropriate, and uncertain exams. These results were then analyzed using Bowker's test of symmetry. Observer agreement was calculated using the kappa statistic. Results: 115 patients (46%) were not classifiable using the 2006 criteria. When the 2010 criteria were applied, the number of not classifiable patients decreased to 40 (16%), with the plurality, 41 (16%), of the not classifiable patients moving to inappropriate. In 2006, 69 (27%) were classified as appropriate, 25 (10%) were uncertain, 42 (17%) inappropriate. In 2010, the appropriate increased to 84 (33%), uncertain increased to 40 (16%), and inappropriate increased to 87 (35%). Bowker's test of symmetry demonstrated a statistically significant change with a p<0.001. Agreement between the two observers assigning patients to classification groups also improved with a kappa of 0.55 using the 2010 criteria compared to kappa of 0.31 in 2006. Conclusion: The number of not classifiable patients decreased using the 2010 criteria and the interobserver agreement improved, suggesting they are more applicable and complete than the 2006 criteria. This decrease in not classifiable patients came primarily from an increase in the number of inappropriate indications.
Modified FOLFOX6 plus bevacizumab with and without nivolumab for first-line treatment of metastatic colorectal cancer: phase 2 results from the CheckMate 9X8 randomized clinical trial
Lenz, Heinz‐Josef , Cohn, Allen Lee, Kochenderfer, Mark D., Élez, Elena , Shao, Spencer H. , Deming, Dustin A. , Holdridge, Regan, Larson, Timothy , Chen, Eric X. , Ucar, Antonio, Cullen, Dana, Baskin-Bey, Edwina, Kang, Tong, Hammell, Amy B, Yao, Jin, Elez, Elena , Chen, Eric , Parikh, Aparna R. , Spigel, David R. , Yoshino, Takayuki , Holdridge, Regan C., Mahipal, Amit , Hammell, A., Yao, Jin, Tabernero, Josep

Journal for ImmunoTherapy of Cancer | March 14, 2024 | Volume: 12 | Issue: 3 | Pages: e008409

10.1136/jitc-2023-008409 | PMID 38485190 Get It

Background Standard first-line therapies for metastatic colorectal cancer (mCRC) include fluoropyrimidine-containing regimens with oxaliplatin and/or irinotecan and a biologic agent. Immunotherapy may enhance antitumor activity in combination with standard therapies in patients with mCRC. Here, we present phase 2 results of nivolumab plus standard-of-care therapy (SOC; 5-fluorouracil/leucovorin/oxaliplatin/bevacizumab) versus SOC in the first-line treatment of patients with mCRC (CheckMate 9X8). Methods CheckMate 9X8 was a multicenter, open-label, randomized, phase 2/3 trial. Eligible patients were at least 18 years of age with unresectable mCRC and no prior chemotherapy for metastatic disease. Patients were randomized 2:1 to receive nivolumab 240 mg plus SOC or SOC alone every 2 weeks. The primary endpoint was progression-free survival (PFS) by blinded independent central review (BICR) per Response Evaluation Criteria in Solid Tumors V.1.1. Secondary endpoints included PFS by investigator assessment; objective response rate (ORR), disease control rate, duration of response, and time to response, all by BICR and investigator assessments; overall survival; and safety. Preplanned exploratory biomarker analyses were also performed. Results From February 2018 through April 2019, 310 patients were enrolled, of which 195 patients were randomized to nivolumab plus SOC (n=127) or SOC (n=68). At 21.5-month minimum follow-up, PFS with nivolumab plus SOC versus SOC did not meet the prespecified threshold for statistical significance; median PFS by BICR was 11.9 months in both arms (HR, 0.81 (95% CI, 0.53 to 1.23); p=0.30). Higher PFS rates after 12 months (18 months: 28% vs 9%), higher ORR (60% vs 46%), and durable responses (median 12.9 vs 9.3 months) were observed with nivolumab plus SOC versus SOC. Grade 3–4 treatment-related adverse events were reported in 75% versus 48% of patients; no new safety signals were identified. Conclusions The CheckMate 9X8 trial investigating first-line nivolumab plus SOC versus SOC in patients with mCRC did not meet its primary endpoint of PFS by BICR. Nivolumab plus SOC showed numerically higher PFS rates after 12 months, a higher response rate, and more durable responses compared with SOC alone, with acceptable safety. Further investigation to identify subgroups of patients with mCRC that may benefit from nivolumab plus SOC versus SOC in the first-line setting is warranted. Trial registration number NCT03414983 .
Validated Symptom Outcomes Following Septal Perforation Repair: Application of the NOSE‐Perf Scale
Taylor, Cullen M. , Bansberg, Stephen F. , Marino, Michael J. , Taylor, Cullen

The Laryngoscope | February 9, 2024 | Volume: 134 | Issue: 7 | Pages: 3067-3072

10.1002/lary.31329 | PMID 38334159 Get It

ObjectiveThe Nasal Obstruction Symptom Evaluation (NOSE)‐Perf scale was developed and validated to measure symptoms associated with nasal septal perforations. This study reports the application of the NOSE‐Perf scale to evaluate symptom change following septal perforation repair.MethodsPatients with NOSE‐Perf evaluations ≥6 months following attempted perforation closure from July 2018 to December 2021 utilizing bilateral nasal mucosal flaps with an interposition graft were eligible for study inclusion. Change in NOSE‐Perf scores were noted. Patient demographics, perforation size, and concurrent functional procedures were analyzed for impact on symptom outcomes.ResultsOne‐hundred and seventeen patients met the study criteria. Seventy‐nine (67.5%) of the patients were female and the mean (range) age at surgery was 47.3 (14–78) years. Repair failure was noted in 7 (6.0%) patients. Mean (SD) preoperative NOSE‐Perf score was 25.3 (95% CI, 23.5–27.1) and postoperative score was 7.9 (95% CI, 6.5–9.3). Minimal clinically important difference (MCID) was estimated and greater than 91% of patients had improvement above this threshold. Patient age, perforation size, or concurrent functional procedures did not impact outcomes. Postoperative scores at short (2–4 months), intermediate (5–8 months), and long‐term (≥9 months) time periods showed significant improvement (all p < 0.001) compared to preoperative NOSE‐Perf scores.ConclusionSignificant reduction in nasal symptoms as measured by the NOSE‐Perf scale is noted following bilateral mucosal flap repair. Although the nose does not completely normalize following repair, clinically important improvement was noted in at least 91% of patients. The NOSE‐Perf scale is positioned to play a role in the standardization of septal perforation evaluation and outcomes assessment.Level of Evidence4 Laryngoscope, 134:3067–3072, 2024
A novel cardiovascular disease risk score for prediction of atherosclerotic disease events in men with prostate cancer.
Cullen, Jennifer , Shanahan, John , Patel, Sagar A. , Guha, Avirup , Guha, Avirup , Stabellini, Nickolas , Tan, Min Choon , Weintraub, Neal L. , Agarwal, Neeraj , Montero, Alberto J.

Journal of Clinical Oncology | January 29, 2024 | Volume: 42 | Issue: 4_suppl | Pages: 314-314

10.1200/jco.2024.42.4_suppl.314 Get It

314 Background: Prostate cancer patients (PC) face an elevated risk of both developing atherosclerotic cardiovascular disease (ASCVD). The American College of Cardiology Pooled Cohort Equations (PCE) for ASCVD predictions may lack accuracy. Methods: Males ≥18 years, diagnosed with PC between 2005-2012 at a hybrid academic-community practice were included. Using XGBoost algorithm we developed using a training subset of the cohort (50% train + 25% test), ranked 33 covariates (including demographic, treatment-related and social determinants of health (SDOH) information) for ASCVD prediction using SHAP (Shapley additive explanations) values. The top 10 predictors were transformed in a predictive equation using logistic regression models. This equation was tested in the cohort validation subset (25%), and subsequently compared to the PCE risk score. Results: We included 1,506 patients, with a median age of 67 (IQR 60-74) years, 13.8% had advanced stage disease (TNM III-IV), 1.5% had high risk PC (Gleason 8-10), and 20.5% received androgen deprivation therapy (ADT). Of those, 10.4% had a 10-year ASCVD risk. The PCE had an area under the curve (AUC)=0.61 and underestimated ASCVD in 0.9% (mean risk=20.1% [95% CI 17.2-23.0] vs. mean predicted risk=19.2% [95% CI 18.6-19.8]). The equation pooled from the top-10 predictors of the ML algorithm (C-index=0.78 [95% CI 0.75-0.81]) achieved an AUC=0.71 (Table). Conclusions: Conventional PCE tend to underestimate ASCVD risk in males with PC. A cancer-specific model inclusive of SDOH exhibits good performance for predicting ASCVD risk in this population. [Table: see text]
Abstract 17626: Apolipoprotein A-IV-Associated Cardiac Amyloidosis: A Classic Presentation of a Rare Condition
Wopperer, Samuel, Aubry, Marie Christine, Grogan, Martha , Cullen, Michael W.

Circulation | December 19, 2023 | Volume: 148 | Issue: Suppl_1 | Pages: No page available

10.1161/circ.148.suppl_1.17626 Get It

Introduction: A 65-year-old male with type one diabetes mellitus underwent a pancreas and kidney transplant approximately seven years ago and has received chronic tacrolimus. He presented with subacute dyspnea on exertion, orthopnea, and edema. His background also includes ongoing chronic kidney disease stage 3A, orthostatic hypotension, and spinal stenosis. On exam, he had abdominal and lower extremity swelling. An echocardiogram showed preserved LVEF, concentric hypertrophy, hyperrefractile myocardium, reduced longitudinal strain with apical sparing, and a tiny pericardial effusion. Hypothesis: His echocardiogram indicated an infiltrative process such as amyloidosis or tacrolimus cardiotoxicity or possibly hypertrophic cardiomyopathy. Methods: Free light chains and protein studies with mass-fixation demonstrated no monoclonal gammopathy. PYP scan was negative for transthyretin amyloidosis. A cardiac MRI showed patchy subendocardial and midmyocardial delayed gadolinium enhancement, supporting the clinical suspicion for cardiac amyloidosis. With the need to exclude tacrolimus toxicity as well, subsequent endomyocardial biopsy revealed apolipoprotein A-IV-associated cardiac amyloidosis (Figure 1). Results: Apolipoprotein A-IV-associated cardiac amyloidosis occurs in about 0.6% of patients with cardiac amyloid and has classic manifestations of LV outflow obstruction, microvascular disease, and especially renal insufficiency. When these features occur in patients with clinical and imaging findings suggesting cardiac amyloidosis despite negative testing for more common types of amyloidosis, clinicians should proceed with endomyocardial biopsy to evaluate for less common forms. Conclusions: We report a rare case of apolipoprotein A-IV-associated cardiac amyloidosis. This case highlights the need for endomyocardial biopsy when clinical suspicion for cardiac amyloidosis persists despite negative testing.
Abstract 14455: Impact of Computer-Interpreted ECGs on the Accuracy of Medical Professionals
Kashou, Anthony H. , Beckman, Thomas J. , Anavekar, Nandan S., Cullen, Michael W. , Angstman, Kurt B. , Shapiro, Brian P. , Kates, Andrew M., Huneycutt, David, Braisted, Andrew , Beard, John , Kerwin, Scott, Rowlandson, Ian, OʼBrien, Kevin , Knohl, Stephen J. , Noseworthy, Peter A. , Sandefur, Benjamin J. , Wiley, Brandon M. , Young, Brian, Baranchuk, Adrián , May, Adam M.

Circulation | December 19, 2023 | Volume: 148 | Issue: Suppl_1 | Pages: No page available

10.1161/circ.148.suppl_1.14455 Get It

Background: The impact of computer ECG interpretation (CEI) on medical professionals’ performance is understudied. This study aims to assess the interpretation proficiency of diverse medical professionals with and without access to CEI reports. Methods: Medical professionals from diverse backgrounds interpreted 60 12-lead ECGs with urgent and non-urgent findings. The interpretation process involved two interpretation phases: (i) 30 ECGs with clinical statements and (ii) the same 30 ECGs and clinical statements in random order along with a CEI report. Diagnostic performance was evaluated based on interpretation accuracy, time per ECG, and self-reported confidence (rated 0 [not confident], 1 [somewhat confident], or 2 [confident]). Results: Among 892 participants, there were 44 (4.9%) primary care physicians, 123 (13.8%) cardiology fellows-in-training, 259 (29.0%) resident physicians, 137 (15.4%) medical students, 56 (6.3%) advanced practice providers, 82 (9.2%) nurses, and 191 (21.4%) allied health professionals. The inclusion of the CEI significantly improved interpretation accuracy by 15.1% (95% CI, 14.3 to 16.0; P<0.001), reduced interpretation time by 52 seconds (95% CI, -56 to -48; P<0.001), and increased confidence by 0.06 (95% CI, 0.03 to 0.09; P=0.003) (Table 1) . Conclusions: CEI integration improves ECG interpretation accuracy, efficiency, and confidence across medical professionals. Nevertheless, even with CEI, significant gaps in ECG interpretation proficiency remain.
Abstract 14425: Independent Predictors of ECG Interpretation Proficiency in Healthcare Professionals
Kashou, Anthony H. , Beckman, Thomas J. , Anavekar, Nandan S., Cullen, Michael W. , Boswell, Christopher L. , Angstman, Kurt B. , Shapiro, Brian P. , Kates, Andrew M., Huneycutt, David, Braisted, Andrew , Kerwin, Scott, Beard, John B. , Rowlandson, Ian, Knohl, Stephen J. , Noseworthy, Peter A. , Sandefur, Benjamin J. , Wiley, Brandon M. , Beard, John, Young, Brian, Baranchuk, Adrián , O'Brien, Kevin, May, Adam M.

Circulation | December 19, 2023 | Volume: 148 | Issue: Suppl_1 | Pages: No page available

10.1161/circ.148.suppl_1.14425 Get It

Background: Accurate ECG interpretation is vital, but variations in skills exist among healthcare professionals. This study aims to identify factors contributing to ECG interpretation proficiency. Methods: Survey data and ECG test scores from participants in the EDUCATE Trial were analyzed. The dependent variable was the test score for interpreting 30 12-lead ECGs. Independent variables included non-modifiable factors (physician status, clinical experience, patient care impact) and modifiable factors (weekly interpretations, training hours, expert supervision frequency). Bivariate and multivariate analyses generated the Comprehensive Model (all factors) and Actionable Model (modifiable factors only). Results: Among 1206 participants, there were 72 (6.0%) primary care physicians, 146 (12.1%) cardiology fellows-in-training, 353 (29.3%) resident physicians, 182 (15.1%) medical students, 84 (7.0%) advanced practice providers, 120 (9.9%) nurses, and 249 (20.7%) allied health professionals. Physicians accounted for 571 (47.3%) of participants, while 453 (37.6%) were non-physicians. Bivariate analysis showed associations between test scores and multiple variables (Table 1) . In the Comprehensive Model, scores were independently associated with weekly interpretations (9.9 score increase; 95% CI 7.9-11.8; P<0.001), physician status (9.0 score increase; 95% CI 7.2-10.8; P<0.001), and training hours (5.7 score increase; 95% CI 3.7-7.6; P<0.001). In the Actionable Model, scores were independently associated with weekly interpretations (12.0 score increase; 95% CI, 10.0-14.0; P<0.001) and training hours (4.7 score increase; 95% CI 2.6-6.7; P<0.001). The Comprehensive and Actionable Models accounted for 18.7% and 12.3% of the variance in test scores, respectively. Conclusions: Being a physician is a non-modifiable predictor, while training and regular practice are modifiable predictors of ECG interpretation performance.
Abstract 14370: Educate: A Randomized Controlled Trial of Education Curriculum Assessment for Teaching Electrocardiography
Kashou, Anthony H. , Beckman, Thomas J. , Anavekar, Nandan S., Cullen, Michael W. , Angstman, Kurt B. , Shapiro, Brian P. , Kates, Andrew M., Sadhu, Justin S., Thakker, Prashanth , Huneycutt, David, Braisted, Andrew , Grauer, Ken, OʼBrien, Kevin , Kaul, Viren , Gambhir, Harvir Singh , Knohl, Stephen J. , Restrepo, Daniel , Noseworthy, Peter A. , Sandefur, Benjamin J. , Wiley, Brandon M. , Smith, Stephen W. , Baranchuk, Adrián , May, Adam M.

Circulation | December 19, 2023 | Volume: 148 | Issue: Suppl_1 | Pages: No page available

10.1161/circ.148.suppl_1.14370 Get It

Background: Gaps in ECG interpretation competency among medical professionals exist, with a need for practical, evidence-based, and accessible learning solutions. We conducted an international, prospective, randomized controlled trial to assess the effectiveness of web-based, self-directed ECG learning. Methods: A total of 1206 diverse medical learners and professionals underwent an initial test, followed by random assignment to one of four groups: (i) online question-bank (questions), (ii) online lectures (lectures), (iii) online, question-bank and lectures (hybrid), or (iv) no resources (control). After 4 months, a post-test was administered to evaluate the overall change in performance. Results: Of all participants, 863 (72%) completed the trial. After the 4-month follow-up, all three online, self-directed intervention groups (questions, lectures, and hybrid) showed significant improvement in overall performance (P<0.001), while the control group did not (P=0.544). The questions, lectures, and hybrid interventions demonstrated score improvements of +11.4% (95% CI, 9.1-13.7; P<0.001), +9.8% (95% CI, 7.8-11.9; P<0.001), and +11.0% (95% CI, 9.2-12.9; P<0.001) respectively, compared to +0.8% (95% CI, -1.2-2.8; P=0.544) for the control group. These improvements were consistent across medical professional groups (Figure 1) . Conclusions: Web-based, self-directed learning resources effectively improved ECG interpretation proficiency for diverse medical learners and professionals.
Abstract 13990: ECG Interpretation Proficiency of Healthcare Professionals
Kashou, Anthony H. , Beckman, Thomas J. , Anavekar, Nandan S., Cullen, Michael W. , Angstman, Kurt B. , Shapiro, Brian P. , Wiley, Brandon W., Kates, Andrew M., Huneycutt, David, Braisted, Andrew , Grauer, Ken, OʼBrien, Kevin , Kaul, Viren , Gambhir, Harvir Singh , Knohl, Stephen J. , Albert, D.J. , Kligfield, Paul, Macfarlane, Peter W. , Noseworthy, Peter A. , Sandefur, Benjamin J. , Smith, Stephen W. , Baranchuk, Adrián , May, Adam M.

Circulation | December 19, 2023 | Volume: 148 | Issue: Suppl_1 | Pages: No page available

10.1161/circ.148.suppl_1.13990 Get It

Background: ECG interpretation is crucial in medical practice, but professionals struggle with achieving and maintaining competency. Identifying proficiency gaps aids in designing educational interventions. Methods: Medical professionals from various disciplines interpreted 30 12-lead ECGs containing commonly taught urgent and non-urgent findings. Performance metrics evaluated were overall adjusted score (% of correctly identified findings using a point-value score based on clinical relevance), unadjusted score (% of correctly identified findings), interpretation time per ECG, and self-reported confidence (rated on an ordinal scale of 0 [not confident], 1 [somewhat confident], or 2 [confident]). Results: Among 1206 participants, there were 72 (6%) primary care physicians (PCPs), 146 (12%) cardiology fellows-in-training (FIT), 353 (29%) resident physicians, 182 (15%) medical students, 84 (7%) advanced practice providers (APPs), 120 (10%) nurses, 249 (21%) allied health professionals, 571 (47%) physicians, and 453 (38%) non-physicians. Participants had a mean adjusted score of 46.9% (± 15.9%), unadjusted score of 56.4% (± 17.2%), interpretation time of 142 seconds (± 67 seconds), and confidence of 0.83 (± 0.53) (Table 1) . Performance varied across groups; cardiology FIT had superior performance in all metrics. Physicians generally outperformed non-physicians, with higher overall adjusted score (52% vs. 43%; p<0.01), unadjusted score (62% vs. 52%; p<0.01), and confidence (0.91 vs. 0.80; p<0.01). Unadjusted score for PCPs was higher than nurses and APPs (58% vs. 47% and 51%; p<0.01) but lower than resident physicians (58% vs. 60%; p<0.01). Allied health professionals outperformed nurses and APPs and closely matched resident physicians and PCPs. Conclusions: Significant gaps in ECG interpretation proficiency exist, emphasizing the need for comprehensive, scalable, and accessible educational tools.
Abstract 11723: Predictors of Post-Operative Atrial Fibrillation in Patients Undergoing Stress Echocardiography Prior to Noncardiac Surgery
Stanko, Kevin M. , Kane, Garvan C. , McCully, Robert B. , Mauck, Karen F. , Cullen, Michael W. , Weingarten, Toby N. , Pellikka, Patricia A.

Circulation | December 19, 2023 | Volume: 148 | Issue: Suppl_1 | Pages: No page available

10.1161/circ.148.suppl_1.11723 Get It

Background: Atrial fibrillation (a-fib) occurs in up to 40% of patients after noncardiac surgery and is associated with increased risk of adverse outcomes. Practice guidelines recommend stress testing, including stress echocardiography (SE) to assess for coronary artery disease in selected high-risk patients prior to noncardiac surgery. The utility of using SE findings for predicting postoperative a-fib is unknown. Hypothesis: Myocardial ischemia can contribute to arrhythmogenic potential; other echocardiographic variables are likely associated with a-fib. Findings on SE may identify patients at risk for a-fib after noncardiac surgery. Aims: To determine if certain SE findings predict a-fib following noncardiac surgery. Methods: The study included patients undergoing pharmacological and exercise SE before noncardiac surgery. The primary outcome was a-fib/flutter within 30 days after surgery. Multivariate analysis was adjusted for age, cardiovascular comorbidities, and markers of surgical risk. Results: This analysis included 2,376 patients (mean age 68 +/- 7 years; 60% male); 1,986 patients had no known history of a-fib/flutter. Of these, 48 (2.4%) developed postoperative a-fib/flutter. In multivariate analysis, SE variables associated with development of new a-fib/flutter included left ventricular dilation (OR 2.11, p=0.049), increased left atrial volume (OR 1.19, p=0.045), and increased left ventricular mass index (OR 1.13, p=0.043) on rest images. The presence of ischemia or infarct on stress echocardiogram was not associated with postoperative a-fib/flutter. A total of 390 patients had a history of paroxysmal a-fib/flutter and were in sinus rhythm at the time of surgery. Of these, 90 (23%) experienced recurrent a-fib/flutter within 30 days of surgery. Multivariate analysis did not reveal any SE variables significantly associated with recurrence, including presence of myocardial ischemia or infarct at the time of SE. Conclusions: All SE variables associated with postoperative a-fib following noncardiac surgery are available from resting images alone. Therefore, SE that includes comprehensive resting images may offer benefit in the pre-operative evaluation of selected patients.