Inaccurate Ethnicity and Race Classification of Hispanics Following Trauma Admission.

BACKGROUND: Race and ethnicity are associated with disparate trauma outcomes. This study seeks to characterize accuracy of trauma registry classification of patient race and ethnicity and to identify factors associated with misclassification. METHODS: A prospective observational study of patients admitted to an urban Level 1 trauma center was conducted over a 6-mo period. Race and ethnicity data recorded in the trauma registry were compared to patients' self-identifying data obtained through in-person interviews. Logistic regression determined rates of discordant race and ethnicity between trauma registry and patient self-identification processes, and identified factors independently associated with misclassification. RESULTS: A total of 444 patients were recruited. 98 (22%) self-identified as Hispanic/Latino. 45 patients self-identifying as Hispanic (45.9%) had inaccurately recorded ethnicity in the trauma registry. There was an increased odds of ethnicity misclassification in younger patients (OR 0.97, P < 0.01) and Spanish-only speakers (OR 11.80, P < 0.001). A decreased odds was found in males (OR 0.43, P < 0.05). No factors increased odds of racial misclassification, while dual English/Spanish speakers (OR 0.05, P < 0.01) wereas found to have decreased odds. Neither ethnicity nor race misclassification was associated with clinical variables. New racial self-identification was observed with 75% of patients who self-identified ethnically as Hispanic also self-identifying racially as Hispanic. CONCLUSIONS: Hispanic trauma patients have racial and ethnic misclassifications regardless of clinical status. Racial and ethnic identification is not sufficiently captured by current standardized questionnaires. Accuracy of hospital level racial data is important for local and national policies to address trauma disparities.

Real world validation of the nonhyperemic index of coronary artery stenosis severity-Resting full-cycle ratio-RE-VALIDATE.

OBJECTIVE: The primary objective was to demonstrate diagnostic equivalence between RFR and iFR in clinical practice. BACKGROUND: The instantaneous wave-free ratio (iFR), a nonhyperemic pressure ratio (NHPR), has been shown to be noninferior to fractional flow reserve (FFR) in determining coronary artery stenosis severity in intermediate lesions. However, iFR has a number of inherent limitations, including sensitive landmarking of the pressure waveform and the assumption that maximal flow and minimal microcirculatory resistance occur during a fixed period within diastole. The resting full-cycle ratio (RFR) is a novel NHPR which evaluates the entire cardiac cycle independent of the ECG, landmark identification, and timing within the cardiac cycle. METHODS: RE-VALIDATE RFR was designed to determine the diagnostic utility of RFR for the physiological assessment of coronary artery disease in clinical practice compared to iFR. RFR was also tested for equivalence (1% margin), diagnostic accuracy, sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), areas under the receiver operated characteristic curve (AUC), and correlations compared to calculated iFR (iFRcalc ). RESULTS: From two centers, 501 blinded rest- and hyperemic pressure recordings from 431 patients were suitable for analysis according to a core laboratory. The mean FFR, RFR, and iFRcalc were 0.80 ± 0.09, 0.90 ± 0.08, and 0.90 ± 0.08, respectively. Based on a binary cut-off approach (RFR/iFR ≤0.89), RFR demonstrated equivalence with iFRcalc (95% confidence interval: 0.025-0.019) with overall diagnostic accuracy 97.8%, sensitivity 97.8%, specificity 97.8%, PPV 96.2%, NPV 98.7%, and AUC 0.96 (0.94-0.97, p < .001). RFR had a mean bias 0.003 (95% limits of agreement: 0.019, -0.025). CONCLUSIONS: RFR was equivalent to iFR in clinical practice. RFR is an alternative NHPR, avoiding the need for hyperemic agents, thus potentially reducing side effects, procedural time and cost compared to FFR.

Incidence and predictors of target lesion failure in patients undergoing contemporary DES implantation-Individual patient data pooled analysis from 6 randomized controlled trials.

BACKGROUND: Drug-eluting stents (DESs) have improved clinical outcomes of patients undergoing percutaneous coronary intervention (PCI). Nevertheless, adverse events related to previously treated lesion still occur. We sought to evaluate the incidence and predictors of target lesion failure (TLF) in patients undergoing contemporary DES implantation. METHODS: Patient-level data from 6 prospective, randomized trials were pooled, and DES treatment outcomes were analyzed at up to 5 years. Primary outcome was TLF (cardiac death, target lesion revascularization, or target vessel myocardial infarction). Cox proportional-hazards model was used to identify predictors of TLF. RESULTS: Overall, 10,072 patients were included in the analysis. TLF rate was 1.7%, 4.3%, and 11.9% at 30 days, 1 year, and 5 years, respectively. The only independent predictor of TLF at 30 days was stent length (hazard ratio [HR] 1.017, 95% CI 1.011-1.024, P < .0001). Moderate/severe calcification, stent length and post procedural diameter sthenosis were predictors between 30 days to 1 year but not at 1 to 5 years. Reference vessel diameter was the only lesion-related predictor at 5 years (P = .003). Clinical predictors of TLF between 30 days and 1 year were diabetes and hypertension (P < .01 for both), and between 1 and 5 years, diabetes (HR 1.40, 95% CI 1.13-1.73, P = .002), prior coronary artery bypass grafting (HR 2.52, 95% CI 1.92-3.30, P < .0001), and prior PCI (HR 1.29, 95% CI 1.02-1.64, P = .04) predicted TLF. CONCLUSIONS: Predictors of TLF vary in the early, late, and very late postprocedural periods. Reference vessel diameter was the only lesion-related predictor of long-term TLF; clinical predictors were diabetes, prior coronary artery bypass grafting, and prior PCI.

Outcomes of the Tryton-dedicated bifurcation stent for the treatment of true coronary bifurcations: Individual-patient-data pooled analysis.

OBJECTIVES: We aimed to evaluate the safety and efficacy of the dedicated Tryton side branch (SB) stent for the treatment of true bifurcations involving large SBs. BACKGROUND: Bifurcation lesions are associated with lower procedural success and a higher risk of adverse cardiac events. Provisional stenting (PS) is currently the default approach for the treatment of bifurcation lesions. The Tryton stent is a dedicated bifurcation stent system for the treatment of true bifurcation lesions. METHODS: We performed an individual-patient-data pooled post-hoc analysis of the Tryton Pivotal randomized controlled trial and post-approval Confirmatory Study. Only patients with true bifurcations involving a SB ≥ 2.25 mm in diameter were included. The primary endpoint was non-inferiority of Tryton compared with PS for target vessel failure (TVF) at 1 year. RESULTS: Of the 411 patients meeting the criteria for enrolment, 287 patients were treated with the Tryton stent and 124 with PS. Procedural success was higher in the Tryton group (95.4 versus 82.3%, P < 0.0001). TVF at 1 year was 8.1% in the Tryton group and 9.7% in the PS group, meeting the pre-specified criteria for non-inferiority established for the randomized controlled trail (pnon-inferiority = 0.02). At 9-month angiographic follow-up, SB diameter stenosis was significantly lower in the Tryton group (29.3 ± 21.9 versus 41.1 ± 17.5, P = 0.0008) and in-segment binary restenosis (diameter stenosis ≥ 50%) was higher in the PS group (19.0 versus 34.2%, respectively, P = 0.052). CONCLUSIONS: In patients with true bifurcations involving a large SB, treatment with the Tryton SD Stent was clinically non-inferior to PS and showed favorable angiographic outcomes.

Moderna COVID-19 Vaccine: A New Player in Vaccine-Induced Thrombosis Without Thrombocytopenia.

This is a case of a 31-year-old male with no past medical history who developed extensive pulmonary embolism (PE) and deep venous thrombosis (DVT) three days after receiving the second dose of the Moderna vaccine. The patient presented with left calf swelling and mild shortness of breath, with no fever or hemodynamic instability. Doppler ultrasound of the left lower extremity showed thrombus in the common femoral, superior, mid-, and distal femoral, popliteal, and posterior tibial veins. Chest CT angiography (CTA) visualized extensive pulmonary emboli in the bilateral main pulmonary, lobar, and segmental arteries. Comprehensive hypercoagulable workup was unrevealing. The leading diagnosis was postulated as vaccine-induced thrombosis (VIT). Due to the diagnosis of bilateral sub-massive PE, the patient was initiated on enoxaparin and continued on direct-acting oral anticoagulation for at least one year. Our report showcases a plausible link between the Moderna vaccine and thrombosis due to the extensive and unprovoked nature of DVT/PE in this patient with a negative hypercoagulable workup. Although the mechanisms behind the messenger ribonucleic acid (mRNA) and double-stranded deoxyribonucleic acid (dsDNA) vaccines vary, the possibility of vaccine-induced thrombosis (VIT) after the Moderna vaccine is highly probable. Vaccine-induced thrombosis should be considered in a patient presenting with unprovoked thrombosis after the Moderna COVID-19 vaccine, and further research needs to be conducted to ascertain the correlation. However, these findings should not dissuade the use of the Moderna vaccine given its proven benefits.

Validation of a novel non-hyperaemic index of coronary artery stenosis severity: the Resting Full-cycle Ratio (VALIDATE RFR) study.

AIMS: Randomised controlled trials have reported instantaneous wave-free ratio (iFR) to be non-inferior to fractional flow reserve (FFR) for major adverse cardiovascular events at one year; however, iFR is limited by sensitive landmarking of the pressure waveform, and the assumption that maximal flow and minimal resistance occur during a fixed period of diastole. We sought to validate the resting full-cycle ratio (RFR), a novel non-hyperaemic index of coronary stenosis severity based on unbiased identification of the lowest distal coronary pressure to aortic pressure ratio (Pd/Pa), independent of the ECG, landmark identification, and timing within the cardiac cycle. METHODS AND RESULTS: VALIDATE-RFR was a retrospective study designed to derive and validate the RFR. The primary endpoint was the agreement between RFR and iFR. RFR was retrospectively determined in 651 waveforms in which iFR was measured using a proprietary Philips/Volcano wire. RFR was highly correlated to iFR (R2=0.99, p<0.001), with a mean bias of -0.002 (95% limits of agreement -0.023 to 0.020). The diagnostic performance of RFR versus iFR was diagnostic accuracy 97.4%, sensitivity 98.2%, specificity 96.9%, positive predictive value 94.5%, negative predictive value 99.0%, area under the receiver operating characteristic curve of 0.996, and diagnostically equivalent within 1% (mean difference -0.002; 95% CI: -0.009 to 0.006, p=0.03). The RFR was detected outside diastole in 12.2% (341/2,790) of all cardiac cycles and 32.4% (167/516) of cardiac cycles in the right coronary artery where the sensitivity of iFR compared to FFR was lowest (40.6%). CONCLUSIONS: RFR is diagnostically equivalent to iFR but unbiased in its ability to detect the lowest Pd/Pa during the full cardiac cycle, potentially unmasking physiologically significant coronary stenoses that would be missed by assessment dedicated to specific segments of the cardiac cycle.