Research Spotlight

Cowey, C.L., Liu, F.X., Kim, R., Boyd, M., Fulcher, N., Krulewicz, S., Kasturi, V. and Bhanegaonkar, A. (2021). “Real-world clinical outcomes with first-line avelumab in locally advanced/metastatic Merkel cell carcinoma in the USA: SPEAR-Merkel.” Future Oncol 17(18): 2339-2350.

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Aim: To assess clinical outcomes in patients with locally advanced (la) or metastatic (m) Merkel cell carcinoma (MCC) initiating first-line (1L) avelumab in a USA community oncology setting. Materials & methods: Adults with laMCC or mMCC initiating 1L avelumab were identified from The US Oncology Network electronic health record database and chart review. Results: Median overall survival and progression-free survival were not reached in laMCC (n = 9) vs 20.2 and 10.0 months in mMCC (n = 19); response rates were similar (66.7% vs 63.2%). Conclusion: This is the first study to show clinical benefit in patients with laMCC receiving 1L avelumab in a US real-world setting. Response rates in patients with mMCC were consistent with pivotal trials. Lay abstract Merkel cell carcinoma (MCC) is a rare and aggressive skin cancer. Because MCC progresses quickly, many patients have a poor prognosis. Avelumab is a type of drug that helps the patient’s immune system to fight cancer. Avelumab was the first such drug approved by the US FDA for treating metastatic MCC based on the results of the JAVELIN Merkel 200 clinical trial. In SPEAR-Merkel, we studied how MCC patients with locally advanced as well as metastatic disease responded when they were treated with first-line avelumab in a real-world setting. These patients were from oncology practices in communities throughout the USA. Overall response rates in SPEAR-Merkel were comparable between patients with locally advanced and metastatic MCC.

Wang, C.H., Wu, M.C., Wu, C.Y., Huang, C.H., Tsai, M.S., Lu, T.C., Chou, E., Wu, Y.W., Chang, W.T. and Chen, W.J. (2021). “Blood gas phenotyping and tracheal intubation timing in adult in-hospital cardiac arrest: a retrospective cohort study.” Sci Rep 11(1): 10480.

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To investigate whether the optimal time to tracheal intubation (TTI) during cardiopulmonary resuscitation would differ by different blood gas phenotypes. Adult patients experiencing in-hospital cardiac arrest (IHCA) from 2006 to 2015 were retrospectively screened. Early intra-arrest blood gas analysis, performed within 10 min of resuscitation, was used to define different phenotypes. In total, 567 patients were included. Non-severe acidosis (pH≧7.15) was associated with favourable neurological outcome (odds ratio [OR]: 4.60, 95% confidence interval [CI] 1.63-12.95; p value = 0.004) and survival (OR: 3.25, 95% CI 1.72-6.15; p value < 0.001) in the multivariable logistic regression analyses. In the interaction analysis, normal blood gas phenotype (pH: 7.35-7.45, PCO(2): 35-45 mm Hg, HCO(3)(-) level: 22-26 mmol/L) × TTI ≦ 6.3 min (OR: 20.40, 95% CI 2.53-164.75; p value = 0.005) and non-severe acidosis × TTI ≦ 6.3 min (OR: 3.35, 95% CI 1.00-11.23; p value = 0.05) were associated with neurological recovery while metabolic acidosis × TTI ≦ 5.7 min (OR: 3.63, 95% CI 1.36-9.67; p value = 0.01) and hypercapnic acidosis × TTI ≦ 10.4 min (OR: 2.27, 95% CI 1.20-4.28; p value = 0.01) were associated with survival. Intra-arrest blood gas analysis may help guide TTI during for patients with IHCA.

Vemmou, E., Quadros, A.S., Dens, J.A., Rafeh, N.A., Agostoni, P., Alaswad, K., Avran, A., Bellli, K.C., Carlino, M., Choi, J.W., El-Guindy, A., Jaffer, F.A., Karmpaliotis, D., Khatri, J.J., Khelimskii, D., Knaapen, P., La Manna, A., Krestyaninov, O., Lamelas, P., Ojeda, S., Padilla, L., Pan, M., Piccaro de Oliveira, P., Rinfret, S., Spratt, J.C., Tanabe, M., Walsh, S., Nikolakopoulos, I., Karacsonyi, J., Rangan, B.V., Brilakis, E.S. and Azzalini, L. (2021). “In-Stent CTO Percutaneous Coronary Intervention: Individual Patient Data Pooled Analysis of 4 Multicenter Registries.” JACC Cardiovasc Interv May 19;S1936-8798(21)00677-4. [Epub ahead of print].

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OBJECTIVES: The authors sought to examine the outcomes of percutaneous coronary intervention (PCI) for in-stent restenosis (ISR) chronic total occlusions (CTOs). BACKGROUND: The outcomes of PCI for ISR CTOs have received limited study. METHODS: The authors examined the clinical and angiographic characteristics and procedural outcomes of 11,961 CTO PCIs performed in 11,728 patients at 107 centers in Europe, North America, Latin America, and Asia between 2012 and 2020, pooling patient-level data from 4 multicenter registries. In-hospital major adverse cardiovascular events (MACE) included death, myocardial infarction, stroke, and tamponade. Long-term MACE were defined as the composite of all-cause death, myocardial infarction, and target vessel revascularization. RESULTS: ISR represented 15% of the CTOs (n = 1,755). Patients with ISR CTOs had higher prevalence of diabetes (44% vs. 38%; p < 0.0001) and prior coronary artery bypass graft surgery (27% vs. 24%; p = 0.03). Mean J-CTO (Multicenter CTO Registry in Japan) score was 2.32 ± 1.27 in the ISR group and 2.22 ± 1.27 in the de novo group (p = 0.01). Technical (85% vs. 85%; p = 0.75) and procedural (84% vs. 84%; p = 0.82) success was similar for ISR and de novo CTOs, as was the incidence of in-hospital MACE (1.7% vs. 2.2%; p = 0.25). Antegrade wiring was the most common successful strategy, in 70% of ISR and 60% of de novo CTOs, followed by retrograde crossing (16% vs. 23%) and antegrade dissection and re-entry (15% vs. 16%; p < 0.0001). At 12 months, patients with ISR CTOs had a higher incidence of MACE (hazard ratio: 1.31; 95% confidence intervals: 1.01 to 1.70; p = 0.04). CONCLUSIONS: ISR CTOs represent 15% of all CTO PCIs and can be recanalized with similar success and in-hospital MACE as de novo CTOs.

Karacsonyi, J., Alaswad, K., Choi, J.W., Vemmou, E., Nikolakopoulos, I., Poommipanit, P., Rafeh, N.A., ElGuindy, A., Ungi, I., Egred, M. and Brilakis, E.S. (2021). “Laser for balloon uncrossable and undilatable chronic total occlusion interventions.” Int J Cardiol May 19;S0167-5273(21)00827-5. [Epub ahead of print].

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BACKGROUND: There is limited information on use of laser in complex percutaneous coronary interventions (PCI). We examined the impact of laser on the outcomes of balloon uncrossable and balloon undilatable chronic total occlusions (CTO) PCI. METHODS: We reviewed baseline clinical and angiographic characteristics and procedural outcomes of 4845 CTO PCIs performed between 2012 and 2020 at 32 centers. RESULTS: Of the 4845 CTO lesions, 752 (15.5%) were balloon uncrossable (523 cases) or balloon undilatable (356 cases) and were included in this analysis. Mean patient age was 66.9 ± 10 years and 83% were men. Laser was used in 20.3% of the lesions. Compared with cases in which laser was not used, laser was more commonly used in longer length occlusions (33 [21, 50] vs. 25 [15, 40] mm, p = 0.0004) and in-stent restenotic lesions (41% vs. 20%, p < 0.0001). Laser use was associated with higher technical (91.5% vs. 83.1%, p = 0.010) and procedural (88.9% vs. 81.6%, p = 0.033) success rates and similar incidence of major adverse cardiac events (3.92% vs. 3.51%, p = 0.805). Laser use was associated with longer procedural (169 [109, 231] vs. 130 [87, 199], p < 0.0001) and fluoroscopy time (64 [40, 94] vs. 50 [31, 81], p = 0.003). CONCLUSIONS: In a contemporary, multicenter registry balloon uncrossable and balloon undilatable lesions represented 15.5% of all CTO PCIs. Laser was used in approximately one-fifth of these cases and was associated with high technical and procedural success and similar major complication rates.

Chiruvolu, A., Claunch, K.M., Garcia, A.J., Petrey, B., Hammonds, K. and Mallett, L.H. (2021). “Effect of continuous positive airway pressure versus nasal cannula on late preterm and term infants with transient tachypnea of the newborn.” J Perinatol May 13. [Epub ahead of print].

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OBJECTIVE: To compare continuous positive airway pressure (CPAP) with nasal cannula (NC) as primary noninvasive respiratory therapy in hypoxic infants for transient tachypnea of the newborn (TTN). STUDY DESIGN: Retrospective cohort study of infants born at ≥34 weeks of gestation between January 1, 2015 and December 31, 2018. RESULT: After adjusting for gestational age and birth weight, the maximum fractional inspired oxygen (FiO(2)) was significantly lower in the CPAP group with an incidence rate ratio (IRR) of 0.85 (95% CI: 0.76-0.96). Although nonsignificant, the CPAP group needed 32% fewer hours on oxygen with an IRR of 0.68 (95% CI: 0.38-1.22). The duration of respiratory support and the incidence of pneumothorax were similar between both groups. CONCLUSION: Comparing CPAP with NC as initial noninvasive respiratory therapy for TTN, significantly lower maximum FiO(2) was observed in the infants of CPAP group without increase in the incidence of pneumothorax.