Research Spotlight

Villablanca, P.A., Vemulapalli, S., Stebbins, A., Dai, D., So, C.Y., Eng, M.H., Wang, D.D., Frisoli, T.M., Lee, J.C., Kang, G., Szerlip, M., Ibrahim, H., Staniloae, C., Gaba, P., Lemor, A., Finn, M., Ramakrishna, H., Williams, M.R., Leon, M.B., O’Neill, W.W. and Shah, B. (2021). “Sex-Based Differences in Outcomes With Percutaneous Transcatheter Repair of Mitral Regurgitation With the MitraClip System: Transcatheter Valve Therapy Registry From 2011 to 2017.” Circ Cardiovasc Interv 14(11): e009374.

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BACKGROUND: Women have a higher rate of adverse events after mitral valve surgery. We sought to evaluate whether outcomes after transcatheter edge-to-edge repair intervention by sex have similar trends to mitral valve surgery. METHODS: The primary outcome was 1-year major adverse events defined as a composite of all-cause mortality, stroke, and any bleeding in the overall study cohort. Patients who underwent transcatheter edge-to-edge repair for mitral regurgitation with the MitraClip system in the Society of Thoracic Surgery/American College of Cardiology Transcatheter Valve Therapy registry were evaluated. Linked administrative claims from the Centers for Medicare and Medicaid Services were used to evaluate 1-year clinical outcomes. Associations between sex and outcomes were evaluated using a multivariable logistic regression model for in-hospital outcomes and Cox model for 1-year outcomes. RESULTS: From November 2013 to March 2017, 5295 patients, 47.6% (n=2523) of whom were female, underwent transcatheter edge-to-edge repair. Females were less likely to have >1 clip implanted (P<0.001) and had a lower adjusted odds ratio of device success (adjusted odds ratio, 0.78 [95% CI, 0.67-0.90]), driven by lower odds of residual mitral gradient <5 mm Hg (adjusted odds ratio, 0.54 [CI, 0.46-0.63]) when compared with males. At 1-year follow-up, the primary outcome did not differ by sex. Female sex was associated with lower adjusted 1-year risk of all-cause mortality (adjusted hazard ratio, 0.80 [CI, 0.68-0.94]), but the adjusted 1-year risk of stroke and any bleeding did not differ by sex. CONCLUSIONS: No difference in composite outcome of all-cause mortality, stroke, and any bleeding was observed between females and males. Adjusted 1-year all-cause mortality was lower in females compared with males.

Katz, P.O., Dunbar, K.B., Schnoll-Sussman, F.H., Greer, K.B., Yadlapati, R. and Spechler, S.J. (2021). “ACG Clinical Guideline for the Diagnosis and Management of Gastroesophageal Reflux Disease.” Am J Gastroenterol Nov 22. [Epub ahead of print].

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Gastroesophageal reflux disease (GERD) continues to be among the most common diseases seen by gastroenterologists, surgeons, and primary care physicians. Our understanding of the varied presentations of GERD, enhancements in diagnostic testing, and approach to patient management have evolved. During this time, scrutiny of proton pump inhibitors (PPIs) has increased considerably. Although PPIs remain the medical treatment of choice for GERD, multiple publications have raised questions about adverse events, raising doubts about the safety of long-term use and increasing concern about overprescribing of PPIs. New data regarding the potential for surgical and endoscopic interventions have emerged. In this new document, we provide updated, evidence-based recommendations and practical guidance for the evaluation and management of GERD, including pharmacologic, lifestyle, surgical, and endoscopic management. The Grading of Recommendations, Assessment, Development, and Evaluation system was used to evaluate the evidence and the strength of recommendations. Key concepts and suggestions that as of this writing do not have sufficient evidence to grade are also provided.

Song, W., Shibuya, N. and Jupiter, D.C. (2021). “Association Between Opioid Use and Diabetes in Patients With Ankle Fracture Repair.” Foot Ankle Int Dec 1;10711007211058157. [Epub ahead of print]. 10711007211058157.

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BACKGROUND: Ankle fractures in patients with diabetes mellitus have long been recognized as a challenge to practicing clinicians. Ankle fracture patients with diabetes may experience prolonged healing, higher risk of hardware failure, an increased risk of wound dehiscence and infection, and higher pain scores pre- and postoperatively, compared to patients without diabetes. However, the duration of opioid use among this patient cohort has not been previously evaluated. The purpose of this study is to retrospectively compare the time span of opioid utilization between ankle fracture patients with and without diabetes mellitus. METHODS: We conducted a retrospective cohort study using our institution’s TriNetX database. A total of 640 ankle fracture patients were included in the analysis, of whom 73 had diabetes. All dates of opioid use for each patient were extracted from the data set, including the first and last date of opioid prescription. Descriptive analysis and logistic regression models were employed to explore the differences in opioid use between patients with and without diabetes after ankle fracture repair. A 2-tailed P value of .05 was set as the threshold for statistical significance. RESULTS: Logistic regression models revealed that patients with diabetes are less likely to stop using opioids within 90 days, or within 180 days, after repair compared to patients without diabetes. Female sex, neuropathy, and prefracture opioid use are also associated with prolonged opioid use after ankle fracture repair. CONCLUSION: In our study cohort, ankle fracture patients with diabetes were more likely to require prolonged opioid use after fracture repair. LEVEL OF EVIDENCE: Level III, prognostic.

Rizkalla, J., Botros, D., Alqahtani, N., Patnala, M., Salama, P., Perez, F.P. and Rizkalla, M. (2021). “Eletromagnetic Detection of Mild Brain Injury: A Novel Imaging Approach to Post Concussive Syndrome.” J Biomed Sci Eng 14(11): 347-360.

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INTRODUCTION: Mild traumatic brain injury (mTBI) is a common injury, with nearly 3 – 4 million cases annually in the United States alone. Neuroimaging in patients with mTBI provides little benefit, and is usually not indicated as the diagnosis is primarily clinical. It is theorized that microvascular trauma to the brain may be present in mTBI, that may not be captured by routine MRI and CT scans. Electromagnetic (EM) waves may provide a more sensitive medical imaging modality to provide objective data in the diagnosis of mTBI. METHODS: COMSOL simulation software was utilized to mimic the anatomy of the human skull including skin, cranium, cerebrospinal fluid (CSF), gray-matter tissue of the brain, and microvasculature within the neural tissue. The effects of penetrating EM waves were simulated using the finite element analysis software and results were generated to identify feasibility and efficacy. Frequency ranges from 7 GHz to 15 GHz were considered, with 0.6 and 1 W power applied. RESULTS: Variations between the differing frequency levels generated different energy levels within the neural tissue-particularly when comparing normal microvasculature versus hemorrhage from microvasculature. This difference within the neural tissue was subsequently identified, via simulation, serving as a potential imaging modality for future work. CONCLUSION: The use of electromagnetic imaging of the brain after concussive events may play a role in future mTBI diagnosis. Utilizing the proper depth frequency and wavelength, neural tissue and microvascular trauma may be identified utilizing finite element analysis.

Simonsen, K.A., Gunn, B.L., Malhotra, A., Beckles, D.L., Koerner, M.M., Tavilla, G. and Reddy, R.C. (2021). “Use of a novel bicarbonate-based Impella 5.5 purge solution in a coagulopathic patient.” J Card Surg 36(12): 4773-4775.

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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.