Research Spotlight

Posted January 15th 2020

The vaginal microbiome in uterine transplantation.

Giuliano Testa, M.D.
Giuliano Testa, M.D.

Jones, B. P., S. Saso, A. L’Heveder, T. Bracewell-Milnes, M. Y. Thum, C. Diaz-Garcia, D. A. MacIntyre, I. Quiroga, S. Ghaem-Maghami, G. Testa, L. Johannesson, P. R. Bennett, J. Yazbek and J. R. Smith (2020). “The vaginal microbiome in uterine transplantation.” BJOG 127(2): 230-238.

Full text of this article.

Women with congenital absolute uterine factor infertility (AUFI) often need vaginal restoration to optimise sexual function. Given their lack of procreative ability, little consideration has previously been given to the resultant vaginal microbiome (VM). Uterine transplantation (UTx) now offers the opportunity to restore these women’s reproductive potential. The structure of the VM is associated with clinical and reproductive implications that are intricately intertwined with the process of UTx. Consideration of how vaginal restoration methods impact VM is now warranted and assessment of the VM in future UTx procedures is essential to understand the interrelation of the VM and clinical and reproductive outcomes. TWEETABLE ABSTRACT: The vaginal microbiome has numerous implications for clinical and reproductive outcomes in the context of uterine transplantation.


Posted January 15th 2020

A Randomized Trial Comparing the Safety, Adherence, and Pharmacodynamics Profiles of Two Doses of Sodium Bicarbonate in CKD: the BASE Pilot Trial.

Donald E. Wesson, M.D.
Donald E. Wesson, M.D.

Raphael, K. L., T. Isakova, J. H. Ix, D. S. Raj, M. Wolf, L. F. Fried, J. J. Gassman, C. Kendrick, B. Larive, M. F. Flessner, S. R. Mendley, T. H. Hostetter, G. A. Block, P. Li, J. P. Middleton, S. M. Sprague, D. E. Wesson and A. K. Cheung (2020). “A Randomized Trial Comparing the Safety, Adherence, and Pharmacodynamics Profiles of Two Doses of Sodium Bicarbonate in CKD: the BASE Pilot Trial.” J Am Soc Nephrol 31(1): 161-174.

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BACKGROUND: Oral sodium bicarbonate (NaHCO3) may preserve kidney function in CKD, even if initiated when serum bicarbonate concentration is normal. Adequately powered trials testing this hypothesis have not been conducted, partly because the best dose for testing is unknown. METHODS: This multicenter pilot trial assessed the safety, tolerability, adherence, and pharmacodynamics of two doses of NaHCO3 over 28 weeks in adults with eGFR 20-44 or 45-59 ml/min per 1.73 m(2) with urinary albumin/creatinine (ACR) >/=50 mg/g and serum bicarbonate 20-28 meq/L. We randomly assigned 194 participants from ten clinical sites to receive higher-dose (HD-NaHCO3; 0.8 meq/kg of lean body wt per day; n=90) or lower-dose (LD-NaHCO3; 0.5 meq/kg of lean body wt per day; n=52) NaHCO3 or matching placebo (n=52). The dose was adjusted depending on side effects. The prescribed dose at week 28 was the primary outcome; a dose was considered acceptable for a full-scale trial if >/=67% of participants were on full-dose and >/=80% were on >/=25% of the per-protocol dose. RESULTS: Mean+/-SD baseline eGFR was 36+/-9 ml/min per 1.73 m(2), serum bicarbonate was 24+/-2 meq/L, and median (IQR) ACR was 181 (25-745) mg/g. Both doses were well tolerated without significant changes in BP, weight, or serum potassium. The proportions of adverse events and hospitalizations were similar across the groups. Consequently, 87% in HD-NaHCO3, 96% in LD-NaHCO3, and 87% in placebo were on full dose at week 28; and 91% in HD-NaHCO3, 98% in LD-NaHCO3, and 92% in placebo were on >/=25% of the per-protocol dose. Mean urinary ammonium excretion was 25% lower and serum bicarbonate concentration was 1.3 meq/L higher in HD-NaHCO3 compared with LD-NaHCO3 at week 28. However, mean ACR increased by 12% in the lower-dose group and 30% in the higher-dose group. CONCLUSIONS: Both NaHCO3 doses were well tolerated over 28 weeks with no significant difference in adverse events or hospitalization compared with placebo. The higher dose lowered urinary ammonium excretion and increased serum bicarbonate more than the lower dose but was associated with a greater increase in ACR. The higher 0.8 meq/kg of lean body wt per day dose of NaHCO3 may be a reasonable choice for future trials.


Posted January 15th 2020

Trends in HeartMate 3: What we know so far.

Timothy J. George, M.D.
Timothy J. George, M.D.

Lanfear, A. T., M. Hamandi, J. Fan, J. M. DiMaio and T. J. George (2020). “Trends in HeartMate 3: What we know so far.” J Card Surg 35(1): 180-187.

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BACKGROUND: The HeartMate 3 left ventricular assist device (LVAD) is a novel, intrapericardial, centrifugal-flow pump with a fully magnetically-levitated rotor designed to provide hemodynamic support in patients with end-stage heart failure. Unique aspects of this LVAD have allowed for improved hemocompatibility and the development of minimally-invasive implantation techniques. METHODS: The PubMed, EMBASE, and Google Scholar databases were searched for publications relating to the HeartMate 3 device, with a focus on hemocompatibility related outcomes, anticoagulation management, and surgical techniques. RESULTS: Nine articles analyzing hemocompatibility related outcomes from two clinical trials, two clinical studies, and one registry series were identified. CONCLUSION: HeartMate 3 has reduced the rate of disabling stroke and pump thrombosis. However, despite increased hemocompatibility due to specialized design features, the residual risk of both surgical, and gastrointestinal bleeding remains a major adverse outcome. Different anticoagulation management and surgical techniques have been evaluated to address the remaining complications.


Posted January 15th 2020

Assessing patients’ preferences for gender, age, and experience of their urogynecologic provider.

Rachel High, D.O.
Rachel High, D.O.

Hoke, T. P., A. A. Berger, C. C. Pan, L. A. Jackson, W. D. Winkelman, R. High, K. A. Volpe, C. P. Lin and H. E. Richter (2019). “Assessing patients’ preferences for gender, age, and experience of their urogynecologic provider.” Int Urogynecol J Dec 11. [Epub ahead of print].

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INTRODUCTION AND HYPOTHESIS: Understanding patient preferences regarding provider characteristics is an under-explored area in urogynecology. This study aims to describe patient preferences for urogynecologic care, including provider gender, age, experience, and presence of medical trainees. METHODS: This was a multicenter, cross-sectional, survey-based study assessing patient preferences with a voluntary, self-administered, anonymous questionnaire prior to their first urogynecology consult. A 5-point Likert scale addressing provider gender, age, experience, and presence of trainees was used. Descriptive statistics summarized patient characteristics and provider preferences. Chi-squared (or Fisher’s exact) test was used to test for associations. RESULTS: Six hundred fifteen women participated from eight sites including all geographic regions across the US; 70.8% identified as white with mean age of 58.5 +/- 14.2 years. Urinary incontinence was the most commonly reported symptom (45.9%); 51.4% saw a female provider. The majority of patients saw a provider 45-60 years old (42.8%) with > 15 years’ experience (60.9%). Sixty-five percent of patients preferred a female provider; 10% preferred a male provider. Sixteen percent preferred a provider < 45 years old, 36% preferred 45-60 years old, and 11% of patients preferred a provider > 60 years old. Most patients preferred a provider with 5-15 or > 15 years’ experience (49% and 46%, respectively). Eleven percent preferred the presence of trainees while 24% preferred trainee absence. CONCLUSION: Patient preferences regarding urogynecologic providers included female gender and provider age 45-60 years old with > 5 years’ experience. Further study is needed to identify qualitative components associated with these preferences.


Posted January 15th 2020

Health Status After Transcatheter Versus Surgical Aortic Valve Replacement in Low-Risk Patients With Aortic Stenosis.

Michael J. Mack M.D.
Michael J. Mack M.D.

Baron, S. J., E. A. Magnuson, M. Lu, K. Wang, K. Chinnakondepalli, M. Mack, V. H. Thourani, S. Kodali, R. Makkar, H. C. Herrmann, S. Kapadia, V. Babaliaros, M. R. Williams, D. Kereiakes, A. Zajarias, M. C. Alu, J. G. Webb, C. R. Smith, M. B. Leon and D. J. Cohen (2019). “Health Status After Transcatheter Versus Surgical Aortic Valve Replacement in Low-Risk Patients With Aortic Stenosis.” J Am Coll Cardiol 74(23): 2833-2842.

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BACKGROUND: In patients with severe aortic stenosis (AS) at low surgical risk, treatment with transcatheter aortic valve replacement (TAVR) results in lower rates of death, stroke, and rehospitalization at 1 year compared with surgical aortic valve replacement; however, the effect of treatment strategy on health status is unknown. OBJECTIVES: This study sought to compare health status outcomes of TAVR versus surgery in low-risk patients with severe AS. METHODS: Between March 2016 and October 2017, 1,000 low-risk patients with AS were randomized to transfemoral TAVR using a balloon-expandable valve or surgery in the PARTNER 3 (Placement of Aortic Transcatheter Valves) trial. Health status was assessed at baseline and 1, 6, and 12 months using the KCCQ (Kansas City Cardiomyopathy Questionnaire), SF-36 (Short Form-36 Health Survey), and EQ-5D (EuroQoL). The primary endpoint was change in KCCQ-OS (KCCQ Overall Summary) score over time. Longitudinal growth curve modeling was used to compare changes in health status between treatment groups over time. RESULTS: At 1 month, TAVR was associated with better health status than surgery (mean difference in KCCQ-OS 16.0 points; p < 0.001). At 6 and 12 months, health status remained better with TAVR, although the effect was reduced (mean difference in KCCQ-OS 2.6 and 1.8 points respectively; p < 0.04 for both). The proportion of patients with an excellent outcome (alive with KCCQ-OS >/=75 and no significant decline from baseline) was greater with TAVR than surgery at 6 months (90.3% vs. 85.3%; p = 0.03) and 12 months (87.3% vs. 82.8%; p = 0.07). CONCLUSIONS: Among low-risk patients with severe AS, TAVR was associated with meaningful early and late health status benefits compared with surgery.