Research Spotlight

Ferdinands, J.M., Gaglani, M., Ghamande, S., Martin, E.T., Middleton, D., Monto, A.S., Silveira, F., Talbot, H.K., Zimmerman, R., Smith, E.R. and Patel, M. (2021). “Vaccine Effectiveness Against Influenza-Associated Hospitalizations Among Adults, 2018-2019, US Hospitalized Adult Influenza Vaccine Effectiveness Network.” J Infect Dis 224(1): 151-163.

Full text of this article.

We estimated vaccine effectiveness (VE) for prevention of influenza-associated hospitalizations among adults during the 2018-2019 influenza season. Adults admitted with acute respiratory illness to 14 hospitals of the US Hospitalized Adult Influenza Vaccine Effectiveness Network (HAIVEN) and testing positive for influenza were cases; patients testing negative were controls. VE was estimated using logistic regression and inverse probability of treatment weighting. We analyzed data from 2863 patients with a mean age of 63 years. Adjusted VE against influenza A(H1N1)pdm09-associated hospitalization was 51% (95% confidence interval [CI], 25%-68%). Adjusted VE against influenza A(H3N2) virus-associated hospitalization was -2% (95% CI, -65% to 37%) and differed significantly by age, with VE of -130% (95% CI, -374% to -27%) among adults 18 to ≤56 years of age. Although vaccination halved the risk of influenza A(H1N1)pdm09-associated hospitalizations, it conferred no protection against influenza A(H3N2)-associated hospitalizations. We observed negative VE for young and middle-aged adults but cannot exclude residual confounding as a potential explanation.

Cowger, J.A., Estep, J.D., Rinde-Hoffman, D.A., Givertz, M.M., Anderson, A.S., Jacoby, D., Chen, L., Brieke, A., Mahr, C., Hall, S., Ewald, G.A., Dirckx, N., Baker, A.T. and Pinney, S.P. (2021). “Variability in Blood Pressure Assessment in Patients Supported with the HeartMate 3TM.” Asaio j June 25. [Epub ahead of print].

Full text of this article.

Targeted blood pressure (BP) control is a goal of left ventricular assist device medical management, but the interpretation of values obtained from noninvasive instruments is challenging. In the MOMENTUM 3 Continued Access Protocol, paired BP values in HeartMate 3 (HM3) patients were compared from arterial (A)-line and Doppler opening pressure (DOP) (319 readings in 261 patients) and A-line and automated cuff (281 readings in 247 patients). Pearson (R) correlations between A-line mean arterial (MAP) and systolic blood pressures (SBP) were compared with DOP and cuff measures according to the presence (>1 pulse in 5 seconds) or absence of a palpable radial pulse. There were only moderate correlations between A-line and noninvasive measurements of SBP (DOP R = 0.58; cuff R = 0.47) and MAP (DOP R = 0.48; cuff R = 0.37). DOP accuracy for MAP estimation, defined as the % of readings within ± 10 mmHg of A-line MAP, decreased from 80% to 33% for DOP ≤ 90 vs. >90 mmHg, and precision also diminished (mean absolute difference [MAD] increased from 6.3 ± 5.6 to 16.1 ± 11.4 mmHg). Across pulse pressures, cuff MAPs were within ±10 mmHg of A-line 62.9%-68.8% of measures and MADs were negligible. The presence of a palpable pulse reduced the accuracy and precision of the DOP-MAP estimation but did not impact cuff-MAP accuracy or precision. In summary, DOP may overestimate MAP in some patients on HM3 support. Simultaneous use of DOP and automated cuff and radial pulse may be needed to guide antihypertensive medication titration in outpatients on HM3 support.

Miles, D., Gligorov, J., André, F., Cameron, D., Schneeweiss, A., Barrios, C., Xu, B., Wardley, A., Kaen, D., Andrade, L., Semiglazov, V., Reinisch, M., Patel, S., Patre, M., Morales, L., Patel, S.L., Kaul, M., Barata, T. and O’Shaughnessy, J. (2021). “Primary results from IMpassion131, a double-blind, placebo-controlled, randomised phase III trial of first-line paclitaxel with or without atezolizumab for unresectable locally advanced/metastatic triple-negative breast cancer.” Ann Oncol Jul 1;S0923-7534(21)02026-3. [Epub ahead of print].

Full text of this article.

BACKGROUND: In the phase III IMpassion130 trial, combining atezolizumab with first-line nanoparticle albumin-bound-paclitaxel for advanced triple-negative breast cancer (aTNBC) showed a statistically significant progression-free survival (PFS) benefit in the intention-to-treat (ITT) and programmed death-ligand 1 (PD-L1)-positive populations, and a clinically meaningful overall survival (OS) effect in PD-L1-positive aTNBC. The phase III KEYNOTE-355 trial adding pembrolizumab to chemotherapy for aTNBC showed similar PFS effects. IMpassion131 evaluated first-line atezolizumab-paclitaxel in aTNBC. PATIENTS AND METHODS: Eligible patients [no prior systemic therapy or ≥12 months since (neo)adjuvant chemotherapy] were randomised 2:1 to atezolizumab 840 mg or placebo (days 1, 15), both with paclitaxel 90 mg/m(2) (days 1, 8, 15), every 28 days until disease progression or unacceptable toxicity. Stratification factors were tumour PD-L1 status, prior taxane, liver metastases and geographical region. The primary endpoint was investigator-assessed PFS, tested hierarchically first in the PD-L1-positive [immune cell expression ≥1%, VENTANA PD-L1 (SP142) assay] population, and then in the ITT population. OS was a secondary endpoint. RESULTS: Of 651 randomised patients, 45% had PD-L1-positive aTNBC. At the primary PFS analysis, adding atezolizumab to paclitaxel did not improve investigator-assessed PFS in the PD-L1-positive population [hazard ratio (HR) 0.82, 95% confidence interval (CI) 0.60-1.12; P = 0.20; median PFS 6.0 months with atezolizumab-paclitaxel versus 5.7 months with placebo-paclitaxel]. In the PD-L1-positive population, atezolizumab-paclitaxel was associated with more favourable unconfirmed best overall response rate (63% versus 55% with placebo-paclitaxel) and median duration of response (7.2 versus 5.5 months, respectively). Final OS results showed no difference between arms (HR 1.11, 95% CI 0.76-1.64; median 22.1 months with atezolizumab-paclitaxel versus 28.3 months with placebo-paclitaxel in the PD-L1-positive population). Results in the ITT population were consistent with the PD-L1-positive population. The safety profile was consistent with known effects of each study drug. CONCLUSION: Combining atezolizumab with paclitaxel did not improve PFS or OS versus paclitaxel alone. CLINICALTRIALS.GOV: NCT03125902.

Cho, J., Marishak-Simon, S., Smith, D.R. and Stevens, A.B. (2021). “The impact of a nutrition counseling program on the use of hospital services for Meals on Wheels clients.” J Prev Interv Community Jun 6;1-13. [Epub ahead of print]. 1-13.

Full text of this article.

Home-delivered meals have shown considerable promise in overcoming nutritional challenges among homebound older adults facing food insecurity and the risk of diabetes, while nutrition counseling provides knowledge and skills for diabetes management. The purpose of this study was to identify the impact of a program combining nutrition counseling with home-delivered meals by examining the use of hospital services 6 months before and after participating in the program. This study included 1009 clients who are at risk for diabetes and who received home-delivered meals and nutrition counseling via Meals on Wheels in Fort Worth, Texas. Hospital service data were extracted from a regional claims database. Generalized linear models were performed to examine changes in use of hospital services 6 months before and after program participation. The mean number of emergency department visits and hospitalizations decreased from 0.69 to 0.50 (p < .001) and from 0.35 to 0.22 (p < .001), respectively. The findings of this study indicate that combining structured nutritional counseling with home-delivered meals may contribute to reducing healthcare use among older adults facing the challenges of diabetes and food insecurity.

Celaj, S. and Kourkoumpetis, T. (2021). “Gallstones in Pregnancy.” Jama 325(23): 2410.

Full text of this article.

Women are at higher risk of gallstones, and that risk increases during pregnancy. Increased hormones during pregnancy can cause higher cholesterol levels and delayed gallbladder emptying, which can lead to formation of gallstones. Nearly 8% of pregnant women form new gallstones by the third trimester, but only about 1% have symptoms. Of those with symptoms, less than 10% develop complications. [No abstract; excerpt from article].