Screening for peripartum cardiomyopathies using artificial intelligence in Nigeria (SPEC-AI Nigeria): Clinical trial rationale and design.

BACKGROUND: Artificial intelligence (AI), and more specifically deep learning, models have demonstrated the potential to augment physician diagnostic capabilities and improve cardiovascular health if incorporated into routine clinical practice. However, many of these tools are yet to be evaluated prospectively in the setting of a rigorous clinical trial-a critical step prior to implementing broadly in routine clinical practice. OBJECTIVES: To describe the rationale and design of a proposed clinical trial aimed at evaluating an AI-enabled electrocardiogram (AI-ECG) for cardiomyopathy detection in an obstetric population in Nigeria. DESIGN: The protocol will enroll 1,000 pregnant and postpartum women who reside in Nigeria in a prospective randomized clinical trial. Nigeria has the highest reported incidence of peripartum cardiomyopathy worldwide. Women aged 18 and older, seen for routine obstetric care at 6 sites (2 Northern and 4 Southern) in Nigeria will be included. Participants will be randomized to the study intervention or control arm in a 1:1 fashion. This study aims to enroll participants representative of the general obstetric population at each site. The primary outcome is a new diagnosis of cardiomyopathy, defined as left ventricular ejection fraction (LVEF) < 50% during pregnancy or within 12 months postpartum. Secondary outcomes will include the detection of impaired left ventricular function (at different LVEF cut-offs), and exploratory outcomes will include the effectiveness of AI-ECG tools for cardiomyopathy detection, new diagnosis of cardiovascular disease, and the development of composite adverse maternal cardiovascular outcomes. SUMMARY: This clinical trial focuses on the emerging field of cardio-obstetrics and will serve as foundational data for the use of AI-ECG tools in an obstetric population in Nigeria. This study will gather essential data regarding the utility of the AI-ECG for cardiomyopathy detection in a predominantly Black population of women and pave the way for clinical implementation of these models in routine practice. TRIAL REGISTRATION: Clinicaltrials.gov: NCT05438576.

Venous thromboembolic and bleeding complications among pregnant women with Klippel-Trenaunay syndrome.

BACKGROUND: Klippel-Trenaunay syndrome (KTS) is a vascular malformation overgrowth syndrome characterized by capillary malformation, venous malformation, and limb overgrowth, with or without lymphatic malformation. Patients are at an increased risk of hemorrhage and venous thromboembolism (VTE). Consequently, women with this condition often are counseled to avoid pregnancy, but minimal data are available on the relationship between pregnancy, VTE, and bleeding risk. OBJECTIVE: To review the risk of VTE and bleeding in pregnant and nulligravid women with KTS. METHODS: A retrospective medical record review was performed of women with KTS, aged ≥18 years, evaluated at Mayo Clinic Rochester, Minnesota, from August 1945 to April 2018. RESULTS: We identified 75 women with ≥1 pregnancy and 64 nulligravid women. VTE prevalence was 14 of 70 (20%) for women with a history of pregnancy and 16 of 64 (25%) for nulligravid women (P = .93). Among the 70 women with a history of pregnancy, 7 of 18 VTE events (39%) occurred in association with pregnancy, with VTE affecting 7 of 151 pregnancies (4.6%). Significant bleeding prevalence was 6 of 70 (8.6%) for women with a history of pregnancy and 6 of 64 (9.4%) for nulligravid women (P = .54). LIMITATIONS: This was a retrospective review. CONCLUSION: The prevalence of VTE and bleeding was similar in patients with KTS, irrespective of pregnancy status.

Clinical Impact of a Restrictive Labor Induction Approval Process.

BACKGROUND/AIMS: The aim of this study was to evaluate the impact of a restrictive labor induction approval process on induction and primary cesarean delivery rates. METHODS: A retrospective cohort study was conducted at a tertiary care academic center from 2006 through 2012. The cohort of deliveries before (pre-intervention) and after (post-intervention) the process included term, singleton pregnancies with no contraindication to vaginal delivery. The primary outcome was induction of labor rates, subgrouped on the basis of whether it was medically or nonmedically indicated. Secondary outcomes included the primary cesarean rate and other maternal and neonatal outcomes. RESULTS: Of 13,753 deliveries, 6,746 met study inclusion criteria. There was a significant decrease in induction rates comparing the pre- and post-intervention periods (21.0 vs. 18.5%, p = 0.01). Nonmedically indicated induction rates also decreased significantly (2.9 vs. 0.6%, p < 0.001). No difference was observed in medically indicated induction (18.1 vs. 17.9%, p = 0.84), the primary cesarean rate (14.4 vs. 15.8%, p = 0.12), or any of the measured neonatal outcomes (p > 0.05). CONCLUSIONS: Implementation of a labor induction approval process was associated with a significant reduction in overall and non-indicated induction rates but did not affect the primary cesarean rate or neonatal outcomes.

How shall we transfuse Hippolyta?

The US Department of Defense recently made the decision to open direct ground combat roles to women. Blood product transfusion is an essential component of the US Military guidelines for tactical combat casualty care and damage control resuscitation, but blood transfusion carries with it the specific side effect of alloimmunization-a uniquely significant side effect for young women who may desire subsequent pregnancies. Presently to be considered are the changes that may need to be made to blood transfusion in the setting of battlefield medicine to optimally care for combat-injured women, as a majority of the existing data regarding the risks of transfusion in the trauma setting involve predominantly men. This article delves into the possibility of a new cohort of women at risk for hemolytic disease of the fetus and newborn, the need for women's health professionals to appropriately counsel women considering serving in direct ground combat roles about this specific risk, and the appropriate steps that should be considered to provide these women optimal medical care.

Longitudinal characterization of renal proximal tubular markers in normotensive and preeclamptic pregnancies.

Glomerular damage is common in preeclampsia (PE), but the extent and etiology of tubular injury are not well understood. The aim of this study was to evaluate tubular injury in patients with PE and to assess whether it predates clinical disease. We performed a prospective cohort study of 315 pregnant women who provided urine samples at the end of the second trimester and at delivery. This analysis included women who developed PE (n = 15), gestational hypertension (GH; n = 14), and normotensive controls (NC; n = 44). Urinary markers of tubular injury, α1-microglobulin (A1M), retinol-binding protein (RBP), kidney-injury molecule-1 (KIM1), complement C5b-9, tissue inhibitor metalloproteinase-2 (TIMP-2), and insulin-like growth factor binding protein-7 (IGFBP-7) were measured by enzyme-linked immunosorbent assay (ELISA) and reported in relation to urine creatinine concentration. Second-trimester concentrations of all markers were similar among groups. At delivery, A1M concentrations were higher in the PE group than in the GH and NC groups as an A1M/creatinine ratio >13 (66.7, 8.3, and 35%, respectively, P = 0.01). Concentrations of C5b-9 were higher in the PE group than in the GH and NC groups (medians 9.85, 0.05, and 0.28 ng/mg, respectively, P = 0.003). KIM1, RBP, TIMP-2, and IGFBP-7 concentrations did not differ among groups at delivery. In conclusion, proximal tubular dysfunction, as assessed by A1M and C5b-9, developed during the interval between the end of the second trimester and delivery in patients with PE. However, this was not matched by abnormalities in markers previously associated with tubular cell injury (KIM-1, IGFBP-7, and TIMP-2).

Antepartum nonobstetrical surgery at ≥23 weeks' gestation and risk for preterm delivery.

OBJECTIVE: We sought to describe the influence of antepartum nonobstetrical surgical procedures performed at viable fetal gestational ages (GAs) on incidence of preterm delivery. STUDY DESIGN: This was a retrospective case series of patients requiring nonobstetrical surgery at ≥23 weeks' gestation at the Mayo Clinic during the interval 1992 through 2014. Data were abstracted for maternal demographic variables, operative procedure, anesthetic type, whether intraoperative fetal monitoring was employed, and both GA and method of delivery. RESULTS: In all, 111 patients underwent 121 operative procedures at a mean GA of 29.2 weeks (range, 23-37 weeks). The majority of procedures were completed under general anesthesia (88/121, 73%), with intraoperative fetal monitoring performed in 14 cases (14/121, 12%); fetal loss occurred during a single unmonitored procedure. Outcome data were available for the majority of patients (86/111, 78%) with preterm delivery occurring in 41% (35/86) at a mean GA of 36.9 weeks (range, 25-41 weeks). Mean interval from procedure to delivery was 7.7 weeks, with 9 patients (9/86, 10%) delivering within 1 week of surgery. Neither procedures requiring entry into the abdominal cavity (P = .65) nor GA at time of procedure (P = 1.0) statistically influenced the risk of preterm delivery. CONCLUSION: Nonobstetrical surgical procedures performed at or beyond fetal viability increased the incidence of preterm delivery regardless of surgical site or timing of procedure, however the risk of intraoperative or immediate postoperative obstetrical complications was relatively low.

Challenging the 4- to 5-minute rule: from perimortem cesarean to resuscitative hysterotomy.

Although perimortem delivery has been recorded in the medical literature for millennia, the procedural intent has evolved to the current fetocentric approach, predicating timing of delivery following maternal cardiopulmonary arrest to optimize neonatal outcome. We suggest a call to action to reinforce the concept that if the uterus is palpable at or above the umbilicus, preparations for delivery should be made simultaneous with initiation of maternal resuscitative efforts; if maternal condition is not rapidly reversible, hysterotomy with delivery should be performed regardless of fetal viability or elapsed time since arrest. Cognizant of the difficulty in determining precise timing of arrest in clinical practice, if fetal status is already compromised further delay while attempting to assess fetal heart rate, locating optimal surgical equipment, or transporting to an operating room will result in unnecessary worsening of both maternal and fetal condition. Even if intrauterine demise has already occurred, maternal resuscitative efforts will typically be markedly improved following delivery with uterine decompression. Consequently we suggest that perimortem cesarean delivery be renamed "resuscitative hysterotomy" to reflect the mutual optimization of resuscitation efforts that would potentially provide earlier and more substantial benefit to both mother and baby.

Cardiac remodelling during pregnancy in women with congenital heart disease and systemic left ventricle.

AIMS: Women with congenital heart disease (CHD) are at risk of pregnancy-related adverse outcomes (PRAO). The purpose of this study was to assess temporal changes in cardiac structure and function (cardiac remodelling) during pregnancy, and the association with PRAO in women with CHD. METHODS AND RESULTS: Retrospective study of pregnant women with CHD and serial echocardiograms (2003-2021). Cardiac structure and function were assessed at pre-specified time points: prepregnancy, early pregnancy, late pregnancy, and postnatal period. PRAO was defined as the composite of maternal cardiovascular, obstetric, and neonatal complications. The study comprised 81 women with CHD (age, 29 ± 5 years). Compared to the baseline echocardiogram, there was a relative increase in right ventricular systolic pressure (RVSP) (relative change 13 ± 5%, P < 0.001, in early pregnancy; and 18 ± 5%, P < 0.001, in late pregnancy). There was a relative decrease in right ventricle free wall strain (RVFWS) (relative change -11 ± 3%, P < 0.001, in late pregnancy; and -11 ± 4%, P = 0.003, in postnatal period), and a relative decrease in RVFWS/RVSP (relative change, -10 ± 5%, P = 0.02 in early pregnancy, -26 ± 7%, P < 0.001, in late pregnancy, and -14 ± 5%, P < 0.001, in postnatal period). Baseline right ventricular to pulmonary arterial (RV-PA) coupling, and temporal change in RV-PA coupling were associated with PRAO, after adjustment for maternal age and severity of cardiovascular disease. CONCLUSION: Women with CHD had a temporal decrease in RV systolic function and RV-PA coupling, and these changes were associated with PRAO. Further studies are required to delineate the aetiology of deterioration in RV-PA coupling during pregnancy, and the long-term implications of right heart dysfunction observed in the postnatal period.

Artificial intelligence-based screening for cardiomyopathy in an obstetric population: A pilot study.

Background: Cardiomyopathy is a leading cause of pregnancy-related mortality and the number one cause of death in the late postpartum period. Delay in diagnosis is associated with severe adverse outcomes. Objective: To evaluate the performance of an artificial intelligence-enhanced electrocardiogram (AI-ECG) and AI-enabled digital stethoscope to detect left ventricular systolic dysfunction in an obstetric population. Methods: We conducted a single-arm prospective study of pregnant and postpartum women enrolled at 3 sites between October 28, 2021, and October 27, 2022. Study participants completed a standard 12-lead ECG, digital stethoscope ECG and phonocardiogram recordings, and a transthoracic echocardiogram within 24 hours. Diagnostic performance was evaluated using the area under the curve (AUC). Results: One hundred women were included in the final analysis. The median age was 31 years (Q1: 27, Q3: 34). Thirty-eight percent identified as non-Hispanic White, 32% as non-Hispanic Black, and 21% as Hispanic. Five percent and 6% had left ventricular ejection fraction (LVEF) <45% and <50%, respectively. The AI-ECG model had near-perfect classification performance (AUC: 1.0, 100% sensitivity; 99%-100% specificity) for detection of cardiomyopathy at both LVEF categories. The AI-enabled digital stethoscope had an AUC of 0.98 (95% CI: 0.95, 1.00) and 0.97 (95% CI: 0.93, 1.00), for detection of LVEF <45% and <50%, respectively, with 100% sensitivity and 90% specificity. Conclusion: We demonstrate an AI-ECG and AI-enabled digital stethoscope were effective for detecting cardiac dysfunction in an obstetric population. Larger studies, including an evaluation of the impact of screening on clinical outcomes, are essential next steps.

Mass spectrometry as a novel method for detection of podocyturia in pre-eclampsia.

BACKGROUND: Podocyturia, i.e. urinary loss of viable podocytes, may serve as a diagnostic tool for pre-eclampsia and as a marker of active renal disease. The current method to detect podocyturia is technically complex, lengthy and requires a high level of expertise for interpretation. The aim of this study was to develop a new technique for the identification of urinary podocytes, based on the detection of podocyte-specific tryptic peptides by liquid chromatography coupled with tandem mass spectrometry (LC-MS/MS), which will provide an operator-independent and highly reproducible method. METHODS AND RESULTS: The diagnosis of pre-eclampsia was confirmed in the presence of hypertension (>140/90 mmHg) and proteinuria >0.3 g/24 h urine. The diagnosis of HELLP was confirmed based on the accepted clinical criteria of hemolysis, elevated liver enzymes and low platelet count. Random urine samples within 24 h prior to delivery were collected and centrifuged. One half of the sediment was cultured for 24 h to select for viable cells and then stained with a podocin antibody, followed by a secondary fluorescein isothiocyanate-labeled antibody to identify podocytes. The second half of the pellet was solubilized, digested and analyzed by LC-MS/MS using an internal standard. We have recruited 13 patients with pre-eclampsia and 6 patients with pre-eclampsia/HELLP syndrome. The presence of podocytes was confirmed in all patients by the podocyte culture method. In the respective samples, the presence of a podocin-specific tryptic peptide was confirmed with LC-MS/MS technology. CONCLUSION: The LC-MS/MS method is a reliable technology for the identification of urinary podocytes, based on the presence of podocyte-specific proteins in the urine.

Peripartum anesthetic management in patients with Ebstein anomaly: a case series.

Ebstein anomaly is a rare congenital cardiac condition associated with displacement and incompetence of the tricuspid valve. Peripartum anesthetic management can be particularly challenging since these patients are at high risk of cardiac failure and tachyarrhythmias. Risk stratification is important since it helps to identify high-risk patients who should deliver at a tertiary care center where a multidisciplinary team (obstetrics, cardiology, anesthesiology, and neonatology) is immediately available. We describe the peripartum anesthetic management of 9 patients with Ebstein anomaly who underwent 12 deliveries at our institution. All patients tolerated neuraxial anesthesia and analgesia well. No maternal or fetal deaths occurred.

Resolution of complete placenta previa: does prior cesarean delivery matter?

OBJECTIVES: The purpose of this study was to prospectively assess the rate of resolution of complete placenta previa diagnosed at second-trimester sonography in patients with and without previous cesarean delivery. METHODS: This prospective study evaluated patients at 3 institutions with complete placenta previa diagnosed at second-trimester screening sonography. All patients were followed with sonography every 4 to 6 weeks until either resolution of the previa or delivery occurred. Patients with persistent/nonresolving complete placenta previa underwent cesarean delivery. RESULTS: A total of 67 patients were enrolled in the study; 18 patients had a prior cesarean delivery. Resolution of placenta previa occurred in 11 of 18 patients (61%) with a prior cesarean delivery, whereas 44 of 49 patients (90%) without a prior cesarean delivery had resolution of placenta previa (P = .012, Fisher exact test). Placental location per se (anterior or posterior) was not associated with resolution of placenta previa (P = .22). Complete placenta previa persisted to delivery in 5 of 9 patients (56%) with a prior cesarean delivery and an anterior placental location. CONCLUSIONS: This prospective study indicates that patients with a prior cesarean delivery and complete placenta previa diagnosed at second-trimester sonography are less likely to have subsequent resolution of the previa when compared to those without a history of cesarean delivery.

Transabdominal and transcervical chorionic villus sampling models to teach maternal-fetal medicine fellows.

OBJECTIVE: Many fellowship programs in maternal-fetal medicine (MFM) lack sufficient exposure and training in chorionic villus sampling (CVS). We describe a novel training model of transabdominal and transcervical CVS. METHODS: A porcine heart simulated a 12-week human uterus with a cervical canal created at the apex of the heart. A piglet was placed within a water-filled condom, which was placed inside the "uterus." A second water-filled condom simulated a maternal bladder. Fresh human placenta was placed between the condom and uterine wall. A zipper-sealed freezer bag with ultrasonic gel simulated an abdominal wall. Transabdominal ultrasound was utilized with this model to perform CVS. RESULTS: The design involved four MFM specialists and three fellows. Twenty-three faculty MFM specialists and eight MFM fellows endorsed the fidelity of both models. One hundred percent of attendees of a procedural workshop agreed that these models could be used to teach proper technique to fellows and faculty. CONCLUSION: We report a novel training model for transabdominal and transcervical CVS to teach proper technique in a nonclinical setting.

Current trends in narcotic use in pregnancy and neonatal outcomes.

OBJECTIVE: The purpose of this study was to evaluate trends and prevalence of chronic prescription narcotic use during pregnancy and the subsequent neonatal outcomes. STUDY DESIGN: We conducted a retrospective cohort study of all deliveries at Mayo Clinic from 1998 through 2009; the data was obtained from prospectively maintained obstetrics and neonatal databases. RESULTS: Over the study time period, there were 26,314 deliveries; 167 women used prescription narcotics chronically during pregnancy. The prevalence of women who used chronic narcotics during their pregnancy increased over the time period from 1998-2009 (P < .0001). Neonatal withdrawal syndrome occurred in 10 of neonates (5.6%), and all but 1 of these neonates required pharmacologic treatment for the disease. CONCLUSION: Chronic narcotic use during pregnancy is increasing in prevalence. Neonatal withdrawal syndrome occurred in 5.6% of the exposed neonates. Although neonatal withdrawal syndrome is uncommon, it is clinically significant. Physicians need to consider the risks and benefits carefully when prescribing narcotic pain medications during pregnancy.

A case series of the anesthetic management of parturients with surgically repaired tetralogy of Fallot.

BACKGROUND: Most case reports of pregnancies after surgical repair of tetralogy of Fallot have focused on cardiovascular and obstetric concerns, with relatively few authors focusing on specific intrapartum and postpartum anesthetic management strategies. METHODS: The Mayo Clinic Congenital Heart Disease Clinic and the Boston Adult Congenital Heart Disease Service databases were cross-referenced with the Mayo Clinic and the Brigham and Women's Hospital Department of Anesthesiology databases to identify patients with tetralogy of Fallot who delivered at their respective hospital from January 1, 1994, to January 1, 2008. We reviewed each medical record to evaluate parturient care during pregnancy, labor, and delivery with a focus on anesthetic management. RESULTS: During the 14-year study period, a total of 27 deliveries in 20 patients with repaired tetralogy of Fallot were identified. Twenty-one deliveries (78%) among 15 parturients (75%) involved a trial of labor; all parturients received neuraxial analgesia for labor and delivery, including 18 (86%) epidural, 2 (10%) combined spinal-epidural, and 1 (5%) continuous spinal anesthetic after an unintended dural puncture. Of the 21 patients undergoing labor, 3 (14%) received invasive arterial blood pressure monitoring; 5 (24%) received continuous telemetry; 3 (14%) experienced congestive heart failure that required diuresis; 4 (19%) had obstetric or neonatal complications; and 3 (14%) had anesthesia complications. Cesarean delivery was required in 4 patients (19%) because of labor complications. Concurrent cardiovascular, obstetric, and anesthetic complications in 1 patient resulted in neonatal death. Six (22%) parturients underwent elective cesarean delivery; 4 received epidural and 2 received spinal anesthesia; no anesthetic or immediate obstetric complications occurred. Among all parturients, 5 deliveries in 5 separate parturients (19% of deliveries) reported symptoms of congestive heart failure at the time of delivery. CONCLUSIONS: Pregnancy outcomes for patients with repaired tetralogy of Fallot were found to be generally favorable. All patients undergoing a trial of labor or cesarean delivery had neuraxial analgesia or anesthesia. Recognition and management of congestive heart failure was necessary in 19% of deliveries.