Research Spotlight

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BACKGROUND: Surgical site infections are a major preventable source of morbidity, mortality, and increased healthcare expenditure following colorectal surgery. Patients with penicillin allergy may not receive the recommended preoperative antibiotics, putting them at increased risk for surgical site infections. OBJECTIVE: This study aimed to evaluate the impact of patient-reported penicillin allergy on preoperative antibiotic prophylaxis and surgical site infection rates among patients undergoing major colon and rectal procedures. DESIGN: Retrospective observational study. SETTING: Tertiary teaching hospital in Dallas. PATIENTS: Adults undergoing colectomy or proctectomy between July 2012 to July 2019. MAIN OUTCOME MEASURES: Preoperative antibiotic choice and surgical site infection. RESULTS: Among 2198 patients included in the study, 12.26% (n=307) reported a penicillin allergy. Patients with penicillin allergy were more likely to be white (82%) and female (54%) (p<0.01). The most common type of allergic reaction reported was rash (36.5%), whereas 7.2% of patients reported anaphylaxis. Patients with self-reported penicillin allergy were less likely to receive beta-lactam antibiotics compared to patients who did not report a penicillin allergy (79.8% vs 96.7%, p<0.001). Overall, there were 143 (6.5%) patients with surgical site infections. On multivariable logistic regression there was no difference in rates of surgical site infection between patients with penicillin allergy vs. those without penicillin allergy (adjusted odds ratio 1.14; 95% confidence interval, 0.71-1.82). LIMITATIONS: Retrospective study design. CONCLUSIONS: Self-reported penicillin allergy among colorectal surgery patients is common, however only a small number of these patients report any serious adverse reactions. Patients with self-reported penicillin allergy are less likely to receive beta-lactam antibiotics and more likely to receive non beta-lactam antibiotics. However, this does not affect the rate of surgical site infection among these patients and patient's penicillin allergy can be safely prescribed non beta-lactam antibiotics without negatively impacting surgical site infection rates.

da Graca, B., Johannesson, L., Testa, G. and Wall, A. (2021). “Uterus transplantation: ethical considerations.” Curr Opin Organ Transplant 26(6): 664-668.

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PURPOSE OF REVIEW: Uterus transplantation (Utx) offers women with absolute uterine factor infertility the opportunity to carry their own pregnancies. As Utx transitions from an experimental to standard clinical procedure, we review the status of the ethical issues applicable to the stakeholders involved. RECENT FINDINGS: With more than 65 Utx procedures reported to date, evidence is accruing that enables the chance of success – a live birth – for the recipient to be weighed against the risks the recipient incurs through the Utx process, as well as risks to living donors undergoing surgery, to children exposed in utero to immunosuppressants and the uterine graft environment, and to third parties related to uterus procurement from multiorgan deceased donors. Experience has also informed aspects of recipient and donor autonomy that must be safeguarded. SUMMARY: Clinical trial results provides a basis for weighing the interests of the stakeholders implicated in Utx, and so can inform transplant centers’ and regulatory bodies’ development of policies and protocols that will determine access to Utx and allocation of organs, together with other considerations of justice. Additional evidence, particularly on long-term outcomes, is needed, and new questions can be expected to arise as access to and indications for Utx broaden.

Sanderson, K., Warady, B., Carey, W., Tolia, V., Boynton, M.H., Benjamin, D.K., Jackson, W., Laughon, M., Clark, R.H. and Greenberg, R.G. (2021). “Mortality Risk Factors Among Infants Receiving Dialysis in the Neonatal Intensive Care Unit.” J Pediatr Nov 16;S0022-3476(21)01097-0. [Epub ahead of print].

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OBJECTIVES: To identify risk factors associated with mortality for infants receiving dialysis in the Neonatal Intensive Care Unit (NICU). STUDY DESIGN: In this retrospective cohort study, we extracted data from the Pediatrix Clinical Data Warehouse on all infants who received dialysis in the NICU from 1999-2018. Using a Cox proportional hazards model with robust standard errors we estimated the mortality hazard ratios associated with demographics, birth details, medical complications, and treatment exposures. RESULTS: We identified 273 infants who received dialysis. Median gestational age at birth was 35 weeks (interquartile values (IQV) 33-37), and median birth weight was 2570 grams (2000-3084), 8% were small for gestational age, 41% white, and 72% male. Over half of the infants (59%) had a kidney anomaly; 71 (26%) infants died before NICU hospital discharge. Factors associated with increased risk of dying after dialysis initiation included lack of kidney anomalies, Black race, gestational age <32 weeks, necrotizing enterocolitis, dialysis within 7 days of life, and receipt of paralytics or vasopressors (all P < .05). CONCLUSION: In this cohort of infants who received dialysis in the NICU over two decades, more than 70% of infants survived. The probability of death was greater among infants without a history of a kidney anomaly and those with risk factors consistent with greater severity of illness at dialysis initiation.

Ponnapakkam, A., Carr, N., Comstock, B., Perez, K., O’Shea, T.M., Tolia, V.N., Clark, R., Heagerty, P., Juul, S.E. and Ahmad, K.A. (2021). “Factors Associated with Outpatient Therapy Utilization in Extremely Preterm Infants.” Am J Perinatol Nov 9. [Epub ahead of print].

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Objective Factors influencing utilization of outpatient interventional therapies for extremely low gestational age newborns (ELGANs) after discharge remain poorly characterized, despite significant risk of neurodevelopmental impairment. We sought to assess the effects of maternal, infant, and environmental characteristics on outpatient therapy utilization in the first two years after discharge using data from the Preterm Erythropoietin Neuroprotection (PENUT) Trial. Study Design This is a secondary analysis of 818 24-27 weeks’ gestation infants enrolled in the PENUT trial who survived through discharge and completed at least one follow-up call or in-person visit between 4 and 24 months of age. Utilization of a state early intervention program (EI), physical (PT), occupational (OT), and speech (ST) therapies was recorded. Odds ratios and cumulative frequency curves for resource utilization were calculated for patient characteristics adjusting for gestational age, treatment group, and birth weight. Results 37% of infants did not access EI and 18% did not use any service (PT/OT/ST/EI). Infants diagnosed with severe morbidities (IVH, ROP, BPD, NEC), discharged with home oxygen, or with gastrostomy placement experienced increased utilization of PT, OT and ST compared to peers. However, substantial variation in service utilization occurred by state of enrollment and selected maternal characteristics. Conclusions ELGANs with severe medical comorbidities are more likely to utilize services after discharge. Therapy utilization may be impacted by maternal characteristics and state of enrollment. Outpatient therapy services remain significantly underutilized in this high-risk cohort. Further research is required to characterize and optimize utilization of therapy services following NICU discharge of ELGANs.

Sommer, R.J., Kim, J.H., Szerlip, M., Chandhok, S., Sugeng, L., Cain, C., Kaplan, A.V. and Gray, W.A. (2021). “Conformal Left Atrial Appendage Seal Device for Left Atrial Appendage Closure: First Clinical Use.” JACC Cardiovasc Interv 14(21): 2368-2374.

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OBJECTIVES: The authors report the first clinical experience with the Conformal Left Atrial Appendage Seal (CLAAS) device. BACKGROUND: The CLAAS device was designed to address the limitations of first-generation left atrial appendage closure (LAAC) devices by providing an implant that is minimally traumatic, can be deployed in a noncoaxial fashion, and does not require postprocedural oral anticoagulation. METHODS: Patients with atrial fibrillation at high stroke risk (CHA(2)DS(2)-VASc score ≥2) were recruited using standard selection criteria. The LAAC procedure was guided by transesophageal echocardiography with patients under general anesthesia. The CLAAS device is composed of a foam cup, with a Nitinol endoskeleton with an expanded polytetrafluoroethylene cover, delivered with a standard delivery system using a tether for full recapture. All patients received dual-antiplatelet therapy for 6 months, followed by aspirin alone. Transesophageal echocardiographic follow-up was scheduled for 45 days and 1 year. RESULTS: Twenty-two patients (63.7% with CHA(2)DS(2)-VASc scores ≥3, 76.2% with HAS-BLED scores ≥3) were enrolled. The device was successfully implanted in 18 patients and unsuccessfully in 4 patients. There were no serious procedural complications. On transesophageal echocardiography performed at 45 days, 1 significant leak (≥5 mm) was seen, which was due to a large posterior lobe not appreciated at the time of implantation, and 1 device-related thrombus was noted, which resolved on oral anticoagulation. There were no periprocedural strokes, major pericardial effusions, or systemic or device embolization. CONCLUSIONS: This first-in-human study demonstrates the clinical feasibility of the CLAAS device for LAAC.