Electrical Storm in COVID-19.
JACC. Case reports
2020; 2 (9): 1256–60
COVID-19 is a global pandemic caused by SARS-CoV-2. Infection is associated with significant morbidity and mortality. Individuals with pre-existing cardiovascular disease or evidence of myocardial injury are at risk for severe disease and death. Little is understood about the mechanisms of myocardial injury or life-threatening cardiovascular sequelae. (Level of Difficulty: Intermediate.).
View details for DOI 10.1016/j.jaccas.2020.05.032
View details for PubMedID 32835266
View details for PubMedCentralID PMC7259914
- Serial Cardiac FDG-PET for the Diagnosis and Therapeutic Guidance of Patients With Cardiac Sarcoidosis JOURNAL OF CARDIAC FAILURE 2019; 25 (4): 307–11
Serial Cardiac FDG-PET for the Diagnosis and Therapeutic Guidance of Patients with Cardiac Sarcoidosis.
Journal of cardiac failure
BACKGROUND: Cardiac fluorodeoxyglucose positron emission tomography (FDG-PET) has emerged as a standard imaging modality for the diagnosis of cardiac sarcoidosis (CS); however, there is a scarcity of data on the use of serial FDG-PET to guide immunosuppressive therapy.OBJECTIVES: To report our experience in using serial FDG-PET for the diagnosis and management of patients with CS, focusing on its utility in ongoing immunosuppression management.METHODS: We studied consecutive patients with CS managed at Stanford University from 2010-2017. We evaluated our experience in using FDG-PET for diagnosis and guidance of immunosuppressive therapy titration in CS.RESULTS: Among 34 patients diagnosed with CS, 16 (47%), 12 (35%) and 14 (41%) patients presented with heart block, heart failure and ventricular arrhythmias, respectively. FDG-PET proved beneficial in the initial diagnosis in 21 (62%) patients. 128 FDG-PET scans were performed (median 3/patient). Ninety-four (73%) FDG-PET scans resulted in a change in therapy, with 42 (33%) FDG-PET scans instrumental for tapering prednisone. Among patients who were initiated on prednisone, the mean dose of prednisone at one year was 9.5 mg/day. Over a median follow-up of 2.3 years, 48% of patients were successfully weaned off of prednisone completely, and 20% were weaned to a maintenance dosage of 5-10 mg/day. During the follow-up period, transplant-free survival was 88%.CONCLUSIONS: The use of serial cardiac FDG-PET for the diagnosis and management of CS was critical for guiding immunosuppression management and resulted in low chronic steroid doses and good disease control within one year of diagnosis.
View details for PubMedID 30825644
- SERIAL CARDIAC FDG-PET IN THE DIAGNOSIS AND THERAPEUTIC GUIDANCE OF PATIENTS WITH CARDIAC SARCOIDOSIS: A STANFORD EXPERIENCE ELSEVIER SCIENCE INC. 2018: 1690
Institutional Scientific Review of Cancer Clinical Research Protocols: A Unique Requirement That Affects Activation Timelines.
Journal of oncology practice
2017; 13 (12): e982–e991
The National Cancer Institute (NCI) requirement that clinical trials at NCI-designated cancer centers undergo institutional scientific review in addition to institutional review board evaluation is unique among medical specialties. We sought to evaluate the effect of this process on protocol activation timelines.We analyzed oncology clinical trials that underwent full board review by the Harold C. Simmons Comprehensive Cancer Center Protocol Review and Monitoring Committee (PRMC) from January 1, 2009, through June 30, 2013. We analyzed associations between trial characteristics, PRMC decisions, protocol modifications, and process timelines using the χ2 test, Fisher's exact test, Wilcoxon rank sum test, Kruskal-Wallis test, and logistic regression.A total of 226 trials were analyzed. Of these, 77% were industry sponsored and 23% were investigator initiated. The median time from submission to PRMC approval was 55 days. The length of review was associated with trial phase, timing of approval, and number of committee changes/clarifications requested. The median process time was 35 days for those approved at first decision, 68 days for second decision, and 116 days for third decision ( P < .001). The median process time was 39 days if no changes/clarifications were requested, 64 days for one to three changes/clarifications, and 73 days for four or more changes/clarifications ( P < .001). Requested changes/clarifications had a greater effect on industry-sponsored trials than on investigator-initiated trials.NCI-mandated institutional scientific review of oncology clinical trials contributes substantially to protocol activation timelines. Further evaluation of this process and the value added to research quality is warranted.
View details for PubMedID 29019706
How Drug Shortages Affect Clinical Care: The Case of the Surgical Anesthetic Propofol.
2015; 50 (9): 798-805
Periodic drug shortages have become a reality in clinical practice. In 2010, in the context of a nationwide drug shortage, our hospital experienced an abrupt 3-month shortage of the surgical anesthetic propofol. The purpose of this retrospective study was to survey the clinical impact of the abrupt propofol shortage at our hospital and to survey for any change in perioperative mortality.A retrospective before-and-after analysis, comparing May through July 2010 (group A, prior to the propofol shortage) to August through October 2010 (group B, during the propofol shortage).In May through July 2010, before the propofol shortage, a majority of patients (80%) received propofol (group A, n = 2,830). In August through October 2010, during the propofol shortage, a majority of patients (81%) received etomidate (group B, n = 3,066). We observed that net usage of etomidate increased by more than 600% in our hospital. Baseline health characteristics and type of surgery were similar between groups A and B. Thirty-day and 2-year mortality were similar between groups A and B. The reported causes and frequency of mortality in groups A and B were also similar.The propofol shortage led to an increased usage of etomidate by more than 600%. In spite of that, we did not detect an increase in mortality associated with the increased use of etomidate during a 3-month propofol shortage.
View details for DOI 10.1310/hpj5009-798
View details for PubMedID 26912921
Impact of NCI-Mandated Scientific Review on Protocol Development and Content
JOURNAL OF THE NATIONAL COMPREHENSIVE CANCER NETWORK
2015; 13 (4): 409-?
The NCI requirement that clinical trials at NCI-designated cancer centers undergo scientific review in addition to Institutional Review Board review is unique among medical specialties. We evaluated the impact of this process on protocol development and content.We analyzed cancer clinical trials that underwent full board review by the Harold C. Simmons Cancer Center Protocol Review and Monitoring Committee (PRMC) from January 1, 2009, through June 30, 2013. We analyzed associations between trial characteristics, PRMC decisions, and protocol modifications using Chi-square testing, Fishers exact testing, and logistic regression.A total of 226 trials were analyzed. Of these, 77% were industry-sponsored and 23% were investigator-initiated. Initial PRMC decisions were: approval (40%), provisional approval (52%), deferral (7%), and disapproval (1%). These decisions were associated with study sponsor (P<.001) and phase (P<.001). Ultimately, 97% of industry-sponsored and 90% of investigator-initiated trials were approved (P=.05). Changes were requested for 27% of industry-sponsored trials compared with 54% of investigator-initiated trials (P<.001). Total changes requested (mean, 5.6 vs 2.4; P<.001) and implemented (mean, 4.6 vs 2.1; P=.008) per protocol were significantly greater for investigator-initiated trials. Changes related to study design were more commonly requested (35% vs 13% of trials) and implemented (40% vs 5% of trials) for investigator-initiated trials compared with industry-sponsored trials (P=.03).NCI-mandated scientific protocol review seems to have a substantial impact on investigator-initiated trials but less effect on industry-sponsored trials. These findings may provide guidance on development and prioritization of institutional protocol review policies.
View details for PubMedID 25870377