Research Spotlight

Simonsen, K. A., B. L. Gunn, A. Malhotra, D. L. Beckles, M. M. Koerner, G. Tavilla and R. C. Reddy (2021). “Use of a novel bicarbonate-based Impella 5.5 purge solution in a coagulopathic patient.” J Card Surg.

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The Impella 5.5 with Smart Assist (Abiomed) is a life-saving treatment option in acute heart failure which utilizes a continuous heparin purge solution to prevent thrombosis. In patients with contraindications to heparin, alternative anticoagulation strategies are required. We describe the stepwise management of anticoagulation in a coagulopathic patient with persistent cardiogenic shock following a coronary artery bypass procedure who underwent Impella 5.5 placement. A direct thrombin inhibitor-based purge solution was utilized while evaluating for heparin-induced thrombocytopenia. The use of a novel bicarbonate-based purge solution (BBPS) was successfully used due to severe coagulopathy. There were no episodes of pump thrombosis or episodes of severe bleeding on the BBPS and systemic effects of alkalosis and hypernatremia were minimal.

Reddy, C. A., K. Wenzke, L. S. Watts, M. Armstrong, V. L. Chen, J. R. Baker and J. W. Chen (2021). “Phenotyping patients with borderline elevated esophageal acid exposure.” Dis Esophagus.

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Acid exposure time (AET) <4% on ambulatory reflux monitoring definitively rules out pathologic gastroesophageal acid reflux, while AET >6% indicates pathologic reflux per the Lyon Consensus, leaving AET of 4-6% as borderline. We aimed to elucidate the borderline AET population and identify metrics that could help differentiate this group. A total of 50 subjects in each group, AET <4, 4-6, and >6% on pH-impedance monitoring between 2015 and 2019, were retrospectively reviewed. In addition to demographic and clinical information, the extracted data included mean nocturnal baseline impedance (MNBI) on reflux study and high-resolution manometry (HRM) parameters and diagnosis. After excluding patients with prior foregut surgery, major esophageal motility disorder, or unreliable impedance testing, a total of 89 subjects were included in the analysis (25 with normal AET < 4%, 38 with borderline 4-6%, 26 with abnormal >6%). MNBI in borderline AET patients was significantly lower compared to normal AET (1607.7 vs. 2524.0 ohms, P < 0.01), and higher than abnormal AET (951.5 ohms, P < 0.01). Borderline subjects had a greater frequency of ineffective esophageal motility (IEM) diagnosis per Chicago classification v3.0 (42.1 vs. 8.0%, P = 0.01), but did not demonstrate any differences compared to abnormal subjects (34.6%, P = 0.56). Patients with borderline AET had an average MNBI that was in between normal AET and abnormal AET. Borderline AET patients also commonly demonstrate IEM on HRM, similar to those with abnormal AET. Our findings can be potentially useful in assigning higher clinical significance for patients found to have borderline AET with concomitant low MNBI and IEM on manometry.

Van Der Pol, B., A. Rao, M. B. Nye, S. Chavoustie, A. Ermel, C. Kaplan, D. Eisenberg, P. A. Chan, L. Mena, S. Pacheco, K. B. Waites, L. Xiao, S. Krishnamurthy, R. Mohan, R. Bertuzis, C. L. McGowin, R. Arcenas, E. M. Marlowe and S. N. Taylor (2021). “Trichomonas vaginalis Detection in Urogenital Specimens from Symptomatic and Asymptomatic Men and Women by Use of the cobas TV/MG Test.” J Clin Microbiol 59(10): e0026421.

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Trichomonas vaginalis is a prevalent sexually transmitted infection (STI). Diagnosis has historically relied on either microscopic analysis or culture, the latter being the previous gold standard. However, these tests are not readily available for male diagnosis, generally only perform well for symptomatic women, and are not as sensitive as nucleic acid amplification tests (NAATs). Men are largely asymptomatic but carry the organism and transmit to their sexual partners. This multicenter, prospective study evaluated the performance of the cobas T. vaginalis/Mycoplasma genitalium (TV/MG) assay for detection of T. vaginalis DNA compared with patient infection status (PIS) defined by a combination of commercially available NAATs and culture using urogenital specimens. A total of 2,064 subjects (984 men and 1,080 women, 940 [45.5%] symptomatic, 1,124 [54.5%] asymptomatic) were evaluable. In women, sensitivity ranged from 99.4% (95% confidence interval [CI] 96.8 to 99.9%) using vaginal samples to 94.7% (95% CI 90.2 to 97.2%) in PreservCyt samples. Specificity ranged from 98.9 to 96.8% (95% CI 95.4 to 97.8%). In men, the cobas TV/MG assay was 100% sensitive for the detection of T. vaginalis in both male urine samples and meatal swabs, with specificity of 98.4% in urine samples and 92.5% in meatal swabs. The cobas TV/MG is a suitable diagnostic test for the detection of T. vaginalis, which could support public health efforts toward infection control and complement existing STI programs.

Saumoy, M., J. Yang, A. Bhatt, J. C. Bucobo, V. Chandrasekhara, A. P. Copland, K. Krishnan, N. A. Kumta, R. J. Law, R. Pannala, M. A. Parsi, E. F. Rahimi, G. Trikudanathan, A. J. Trindade and D. R. Lichtenstein (2021). “Endoscopic therapies for gallbladder drainage.” Gastrointest Endosc 94(4): 671-684.

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BACKGROUND AND AIMS: Endoscopic management of acute cholecystitis has expanded in patients who are considered nonoperative candidates. Traditionally managed with percutaneous cholecystostomy (PC), improvement in techniques and devices has led to increased use of endoscopic methods for gallbladder drainage. This document reviews technical aspects of endoscopic transpapillary gallbladder drainage (ET-GBD) and EUS-guided GBD (EUS-GBD) as well as their respective technical/clinical success and adverse event rates. Available comparative data are also reviewed among nonsurgical gallbladder drainage techniques (PC, ET-GBD, and EUS-GBD). METHODS: The MEDLINE database was searched through March 2021 for relevant articles by using keywords including “acute cholecystitis,” “interventional EUS,” “percutaneous cholecystostomy,” “transpapillary gallbladder drainage,” “EUS-guided gallbladder drainage,” “lumen-apposing metal stent,” “gallbladder stenting,” and “endoscopic gallbladder drainage.” The manuscript was drafted by 2 authors and reviewed by members of the American Society for Gastrointestinal Endoscopy Technology Committee and subsequently by the American Society for Gastrointestinal Endoscopy Governing Board. RESULTS: Multiple studies have demonstrated acceptable outcomes comparing PC and both endoscopic gallbladder drainage techniques, ET-GBD and EUS-GBD. Published data suggest that endoscopic gallbladder drainage techniques may be associated with lower rates of adverse events and improved quality of life. However, there are important clinical considerations for choosing among these treatment options, requiring a multidisciplinary and collaborative approach to therapeutic decision-making in these patients. CONCLUSIONS: The implementation of EUS-GBD and ET-GBD in high-risk surgical patients with acute cholecystitis may result in favorable outcomes when compared with PC. Further improvements in techniques and training should lead to more widespread acceptance and dissemination of these treatment options.

Januzzi, J. L., Jr., F. Zannad, S. D. Anker, J. Butler, G. Filippatos, S. J. Pocock, J. P. Ferreira, N. Sattar, S. Verma, O. Vedin, J. Schnee, T. Iwata, D. Cotton and M. Packer (2021). “Prognostic Importance of NT-proBNP and Effect of Empagliflozin in the EMPEROR-Reduced Trial.” J Am Coll Cardiol 78(13): 1321-1332.

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BACKGROUND: The relationship between the benefits of empagliflozin in heart failure with reduced ejection fraction (HFrEF) and N-terminal pro-B-type natriuretic peptide (NT-proBNP) has not been reported. OBJECTIVES: The authors sought to evaluate the relationship between NT-proBNP and empagliflozin effects in EMPEROR-Reduced (Empagliflozin Outcome Trial in Patients With Chronic Heart Failure With Reduced Ejection Fraction). METHODS: Patients with HFrEF were randomly assigned to placebo or empagliflozin 10 mg daily. NT-proBNP was measured at baseline, 4 weeks, 12 weeks, 52 weeks, and 100 weeks. Patients were divided into quartiles of baseline NT-proBNP. RESULTS: Incidence rates for each study outcome were 4- to 6-fold higher among those in the highest versus lowest NT-proBNP quartiles (≥3,480 vs <1,115 pg/mL). Study participants with higher NT-proBNP had 2- to 3-fold total hospitalizations higher than the lowest NT-proBNP quartile. Empagliflozin reduced risk for major cardiorenal events without heterogeneity across NT-proBNP quartiles (primary endpoint P(interaction) = 0.94; renal composite endpoint P(interaction) = 0.71). Empagliflozin treatment significantly reduced NT-proBNP at all timepoints examined; by 52 weeks, the adjusted mean difference from placebo was 13% (P < 0.001). An NT-proBNP in the lowest quartile (<1,115 pg/mL) 12 weeks after randomization was associated with lower risk for subsequent cardiovascular death or heart failure hospitalization regardless of baseline concentration. Treatment with empagliflozin resulted in 27% higher adjusted odds of an NT-proBNP concentration of <1,115 pg/mL by 12 weeks compared with placebo (P = 0.01). CONCLUSIONS: In EMPEROR-Reduced, higher baseline NT-proBNP concentrations were associated with greater risk for adverse heart failure or renal outcomes, but empagliflozin reduced risk regardless of baseline NT-proBNP concentration. The NT-proBNP concentration after treatment with empagliflozin better informs subsequent prognosis than pretreatment concentrations. (Empagliflozin Outcome Trial in Patients With Chronic Heart Failure With Reduced Ejection Fraction [EMPEROR-Reduced]; NCT03057977).