key: cord-0789347-boqdcvzc
authors: Narang, Kavita; Elrefaei, Amro; Wyatt, Michelle A.; Warner, Lindsay L.; Abrao Trad, Ayssa Teles; Segura, Leal G.; Bendel-Stenzel, Ellen; Ahn, Edward S.; Arendt, Katherine W.; Qureshi, M. Yasir; Ruano, Rodrigo
title: Fetal Surgery in the era of SARS-CoV-2 pandemic: A single institution review
date: 2020-08-19
journal: Mayo Clin Proc Innov Qual Outcomes
DOI: 10.1016/j.mayocpiqo.2020.08.001
sha: e46ae37b40c0516ea2ee8cb3726b03385fad9f37
doc_id: 789347
cord_uid: boqdcvzc

Abstract Objectives To cope with the changing healthcare services in the era of SARS-CoV-2 pandemic; we share the institutional framework for the management of anomalous fetuses requiring fetal intervention at Mayo Clinic, Rochester, Minnesota. To assess the success of our program during this time, we compare intraoperative outcomes of fetal interventions performed during the pandemic, with the previous year. Patients We implemented our testing protocol on patients undergoing fetal intervention at our institution between March 1st and May 15th 2020 and we compared to same period a year before. A total of 17 pregnant patients with anomalous fetuses who met criteria for fetal intervention were included; 8 from 2019 and 9 from 2020. Methods Our testing protocol was designed based on our institutional perinatal guidelines, surgical requirements from Infection prevention and control (IPAC) committee and input from our fetal surgery team; with focus on urgency of procedure and maternal SARS-CoV-2 screening status. We compared the indications, types of procedures, maternal age, gestational age at procedure, type of anesthesia used and duration of procedure for cases performed at our institution between March 1st, 2020 to May 15th, 2020 and the same period in 2019. Results There were no statistically significant differences between the number of cases, indications, types of procedures, maternal age, gestational age, types of anesthesia and duration of procedures (p values were all > 0.05) between pre-SARS-CoV-2 pandemic in 2019 and SARS-CoV-2 pandemic in 2020. Conclusion Adoption of new institutional protocols during SARS-CoV-2 pandemic, with appropriate screening and case selection, allows provision of necessary fetal intervention with maximum benefit to mother, fetus and health care provider.

appropriate screening and case selection, allows provision of necessary fetal intervention with maximum benefit to mother, fetus and health care provider.

The advancement of prenatal diagnostic imaging has led to early and more accurate detection of congenital malformations in the antenatal period as well as to develop new and safe in utero

Several prenatal congenital malformations such as twin to twin transfusion syndrome (TTTS) 3 , twin anemia polycythemia syndrome (TAPS) 3 , lower urinary tract obstruction (LUTO) 4, 5 , congenital diaphragmatic hernia (CDH) [6] [7] [8] [9] and myelomeningocele 10, 11 carry varying degrees of perinatal morbidity and mortality. Fetal intervention to modify outcome is potentially available, and the decision to perform these procedures and timing of intervention can significantly impact maternal and/or fetal outcomes 12 . These interventions can be minimally invasive, such as ultrasound guided or fetoscopic procedures, or more invasive procedures requiring laparotomy and a uterine incision 13 . Fetal interventions are usually performed in the operating room (OR), and the type and timing of procedure and choice of anesthesia is dependent on multiple factors including diagnosis, indications, maternal co-morbidities, gestational age and placental location.

On March 11 th 2020; the World Health Organization (WHO) declared a global pandemic of the SARs-CoV-2 virus 14 ; the etiologic agent of COVID-19 15 . The pandemic has demanded significant adjustments in health care systems worldwide, including delivery of prenatal care, labor and delivery care, and medically indicated fetal interventions for anomalous fetuses.

Different perinatal societies including the American College of Obstetrics and Gynecology (ACOG) 16 , Society for Maternal Fetal Medicine (SMFM) 17, 18 , Royal College of Obstetrics and Gynecology (RCOG) 19 have published individual recommendations to guide patients, healthcare workers and healthcare institutions on prenatal and labor and delivery care 20 . Fetal intervention societies including North American Fetal Therapy Network (NAFTNet) 21 

Medicine and Surgery society (IFMMS) 22 have published guidelines specific to fetal interventions. These recommendations need to be adopted and adjusted to fit the infrastructure, resources and demands of each healthcare institution and the patient population they serve.

The present study aims to report our experience with managing fetal surgeries in our institute during the SARs-CoV-2 pandemic, in order to evaluate the impact of the pandemic in our program.

The present study is a retrospective chart review comparing the intraoperative outcomes of fetal In March 2020, significant institutional changes occurred limiting the type and number of surgical cases able to be performed. With the establishment of in-house SARS-CoV-2 screening, our institution was quick to adopt universal testing for patients admitted to Labor & Delivery beginning March 15 th , 2020. The addition of screening for those undergoing planned surgical interventions began April 1 st , 2020. Fetal intervention cases can be urgent or limited to narrow timeframes for benefit. Patients requiring these interventions intersected both the Labor & Delivery and surgical practice policies and therefore a protocol was adopted specifically for these cases as summarized in Figure 1 .

Our fetal surgery team developed the "Fetal surgery during SARS-CoV-2 pandemic protocol", adopted from our institutional guidelines, including Mayo Clinic perinatal committee guidelines and surgical requirements outlined by our Infection prevention and control (IPAC) committee.

The SARS-CoV-2 screening test is done via nasopharyngeal (NP) swabbing and sent for quantitative real time polymerase chain reaction (qRT-PCR). Serum antibody testing for SARS-CoV-2 was added to the routine screening protocol starting April 21 st , 2020; turn-around time for both these tests is between 24 to 48 hours. In the setting of emergencies, procedures are performed even if results have not returned. If patients are symptomatic or test results are positive for SARS-CoV-2; a multidisciplinary discussion is required to review risks versus benefits of proceeding. While testing is obtained to inform all teams and the patient regarding the risks of the procedure, all surgical patients are treated as suspected SASR-CoV-2 carriers.

Patients are also usually allowed one asymptomatic healthy visitor to accompany them on the day of the procedure; routine NP swab for SARS-CoV-2 is not performed per visitor policy; but they are screening to ensure no recent exposures or concern or infections. Visitors have to wear a mask at all times within the hospital. Table 1 summarizes the type of personal protective equipment (PPE) used in different scenarios.

Though our protocol was specifically tailored to fit our institution requirements, and has only been utilized at our institution; it is compliant with recommendations put forth by ACOG 16 This protocol was implemented on April 1 st , 2020, and in order to objectively assess its efficacy;

we performed a retrospective chart review of all fetal intervention cases performed at our institutional fetal surgery program between March 1 st to May 15 th 2019 and March 1 st to May 15 th 2020. This time period was chosen to reflect the start of the pandemic to present; and to allow us to include as many patients as possible. IRB approval (ID-19-008729) was obtained prior to chart review. Patients who met candidacy and underwent fetal intervention within the specified time frame were included. Those who were evaluated but did not undergo intervention were excluded. Data abstracted include number of patients that presented for consultation, number of patients that underwent intervention, diagnoses and indications for intervention, type of procedure performed, maternal age at presentation, gestational age at intervention, type of anesthesia (local, regional or general), total intraoperative preparation time defined as anesthesia start time to surgery start time-stratified by type of anesthesia (Monitored Anesthesia Care (MAC), or General anesthesia (GA)), and total procedure time defined as anesthesia start time to anesthesia stop time-also stratified by type of anesthesia, MAC or GA.

The total intraoperative preparation time (anesthesia start to procedure start) and total procedure times (anesthesia start to anesthesia stop) were defined as our primary outcome.

Statistical analysis was performed using Fisher test, Chi-square test and Mann-Whitney U test based on the distribution of the variables (MEDCALC software version 19.3, MedCalc Software Ltd, Belgium). Statistical significance was considered when P values < 0.05.

A total number of 37 patients were referred for evaluation during the study period; 15 patients in 2019; pre-SARS-CoV-2 pandemic, and 22 patients in 2020; during the SARS-CoV-2 pandemic. In 2019, a total of 8 cases met criteria for intervention. These include 2 (25%) cases of Quintero Type II TTTS, 1 (12.5%) case of TAPS, 2 (25%) cases of myelomeningocele, 2 (25%) cases of In 2020, a total of 9 cases met criteria for undergoing intervention. These included 5 (55.6%) cases of TTTS (3 type II and 2 type III), 1 (11.1%) case of TAPS, and 3 (33.3%) cases of myelomeningocele. Procedures performed include 6 (66.7%) fetoscopic laser ablation of placental anastomoses for TTTS and TAPS, and 3 (33.3%) open in-utero repair of myelomeningocele. Mean maternal age was 30 years old (range 21-35). Mean gestational age at which the procedures were performed was 21/0 weeks (range 16/2 -25/1 weeks). MAC anesthesia was used in 6 (66.7%) of cases and GA with epidural block was used in 3 (33.3%) of cases. Mean intraoperative preparation time for MAC and GA were 40 minutes (range 33-52 minutes) and 52 minutes (range 38-59 minutes) respectively. Mean total procedure time (anesthesia start to anesthesia stop time) for MAC was 104 minutes (range 91-121 minutes), and for GA was 241 minutes (range 211-296 minutes).

No cases had positive qRT-PCR or serum antibodies for SARS-CoV-2. Overall, there were no differences between 2019 and 2020, in the number of procedures performed, maternal age, gestational age at procedure type of anesthesia, intraoperative preparation time and total procedure time Interestingly, we performed more fetoscopic laser ablations of the placental anastomoses for severe twin-to-twin transfusion syndrome during the SARs-Cov-2 pandemic.

The present study demonstrated that there were no significant differences between the total number of fetal intervention cases performed and evaluated in our institution during and before the SARs-CoV-2 pandemic. Although not statistically significant; procedures performed in 2019 had a greater variety including emergent, urgent and non-urgent cases such as placental laser ablation for TTTS, vesicoamniotic shunt placement for LUTO, fetsoscopic and open repairs for myelomeningocele and bilateral thoracoamniotic shunt placement. In 2020, 6 out of 9 (66.6%) cases performed were emergent placental laser ablation for TTTS, because deference could result in one or both fetal demise. The other 3 cases were open myelomeningocele repairs. None of our patients had a positive PCR test. Despite implementing SARs-CoV-2 precautions and following the institutional protocols, we did not observe increased surgical time.

Patients that were referred to the Fetal Center at Mayo Clinic for evaluation of potential fetal intervention underwent advanced level ultrasound followed by a consultation with a fetal interventionist, neonatologist (if pregnancy is viable, > 23weeks gestation),anesthesiologist, and additional pediatric subspecialist specific to individual diagnosis. Our institution adopts a multidisciplinary approach to our fetal intervention cases.

Cases such as laser ablation of placental anastomoses for TTTS or TAPS, and or percutaneous blood sampling (PUBS) and transfusion for fetal anemia can prevent fetal demise; however, others such as myelomeningocele repair 24 and FETO for CDH 25 are done to decrease neonatal morbidity and mortality. In these situations, the mother is typically asymptomatic and carries very minimal personal risk of morbidity or mortality. In cases of transfusion or laser ablation, delays of hours can result in fetal demise and thus are considered emergent cases, while other procedures need to be performed in a timely fashion at a certain gestational age, to have maximal neonatal benefit. They are considered urgent and cannot be significantly delayed, given the short period when fetal intervention can change the natural history of the congenital anomaly.

If any patients in our cohort did have a positive SARS-CoV-2 test, we could choose to delay some of the urgent and non-urgent procedures such as myelomeningocele repair or FETO for CDH, as long as the new procedure date still falls within the acceptable gestational age range for performing intervention. Of note, none of the providers involved in the care of fetal interventions became ill during this study period. If there was any concern of provider exposure to COVID-19, they were advised to self-quarantine and not present to work per institutional policy, put forth by IPAC.

Our "Fetal surgery during SARS-CoV-2 pandemic" protocol is up to date at the time of submission; however, it continues to evolve and should only be used as a template for other individual institutions rather than a prescriptive copy. It is also important to continue to modify and update the protocols to keep up with changing policies, emerging evidence and community disease activity. To preserve N95 or PAPR resources 32, 33 , efforts to reduce high risk AGP's could include local or regional anesthesia 33 . However, due to adequate N95 and PAPR supplies and re-use/recycle protocols at our institution, we did not need to modify our anesthetic plans as a result of the pandemic. Institutions with high disease burden or limited PPE could consider delaying non emergent procedures if safely feasible; and perform certain procedures such as myelomeningocele repair under regional anesthesia or laser ablation of placental anastomoses for TTTS and TAPS cases under local anesthesia.

Congenital malformations account for approximately 3% of all pregnancies 34 , and few centers around the United States currently have the ability to offer fetal interventions. However, anomalous fetuses represent a highly important subset of patients where life changing treatment options could be offered. Further investigation comparing multi-institution protocols to evaluate the impact of SARS-CoV-2 pandemic on the ability to perform these interventions and their outcomes are critical to the care of these patients. In addition, multicenter studies are necessary to evaluate the impact of SARs-CoV-2 infection to those patients who have undergone or will undergo in utero interventions.

Several factors highlight the strength of our study; the availability of healthcare resources and personnel, along with ease in collaboration at our institution allowed us to rapidly design and implement this important protocol. This, in conjunction with our in house SARS-CoV-2 screening abilities, has made it possible for us to continue to offer fetal interventions to our patients during the pandemic. The teams involved in patient counseling, selection and performing the surgery were the same for 2019 and 2020; this eliminates design, selection and procedural bias, while giving us the advantage of being able to directly compare the outcomes of cases performed during the SARS-CoV-2 pandemic with last year.

Our study is limited by the small sample size, as fetal surgeries account for only a small subset of surgeries performed annually. Our data is also limited by representing only a single institution protocol. The majority of our patients are from the Midwest area with low community prevalence of SARS-CoV-2. As of June 3 rd , 2020, there are a total of 25,870 cases that tested positive for SARS-CoV-2 in the state of Minnesota; with only 654 (2.5%) within Olmsted County where our institution is located 35 . Our findings may not translate to communities with higher case prevalence and disease burden.

Our study demonstrates that SARs-CoV-2 pandemic has minimally impacted our institution's surgical outcomes (without statistical significance), and our capacity to offer complex fetal surgeries. Our program has established specific protocols based on institutional guidelines and national societies that have enabled us to safely proceed with fetal interventions during the SARs-CoV-2 pandemic. Table 1 : Summary of terms and abbreviations used in the protocol for fetal intervention during SARS-CoV-2 pandemic Table 1 

Footnote: a AGP = Aerosal generating procedure, MDP = Modified droplet precaution, SP = standard precautions, PUI = person under investigation.

Definition Equipment PPE Personal protective equipment Ex: masks, gloves, gowns

Tight fitting mask that is protective against airborne particles and droplets N95 or PAPR (powered airpurifying respirators)

Protective against droplets Safety glasses or face shields (shields may also help protect respirators to allow longer use) Aerosol generating procedure (AGP)

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The purpose of this form is to provide readers of your manuscript with information about your other interests that could influence how they receive and understand your work. The form is designed to be completed electronically and stored electronically. It contains programming that allows appropriate data display. Each author should submit a separate form and is responsible for the accuracy and completeness of the submitted information. The form is in four parts.

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First Name Michelle Last Name Wyatt Manuscript No.: MCPIQO-2020-0138 Manuscript Title: "Fetal Surgery in the era of SARS-CoV-2 pandemic: A single institution review"Date Submitted: July 23, 2020

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