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Vincent T Armenti

Publications and source records attributed to Vincent T Armenti.

12 recordsLinked to original sources

Pregnancy outcomes in solid organ transplant recipients with exposure to mycophenolate mofetil or sirolimus.

BACKGROUND: Animal and limited human studies have raised concerns as to the safety of in utero exposure to mycophenolate mofetil (MMF) and sirolimus (SRL) in transplant recipients. This study examined the outcomes of pregnancies with exposure to MMF or SRL from 30 female transplant recipients (39 pregnancies) who have reported pregnancies to the National Transplantation Pregnancy Registry. METHODS: Data were collected via questionnaires, phone interviews and medical records. RESULTS: There were 18 kidney recipients reporting 26 pregnancies with exposure to MMF: 15 livebirths (LB), 11 spontaneous abortions (SA). Structural malformations were reported in four of the 15 children (26.7%) including: hypoplastic nails and shortened fifth fingers (one), microtia with cleft lip and palate (one), microtia alone (one), and neonatal death with multiple malformations (one). One kidney/pancreas (K/P) recipient reported one SA. Three liver recipients reported three pregnancies; two LB (no malformations), and one second trimester SA. Two heart recipients reported one LB (no malformations) and two SA. SRL exposures included seven recipients (four kidney, one K/P and two liver) reporting four LB (one infant whose mother was switched from MMF to SRL during late pregnancy had cleft lip and palate and microtia) and three SA. CONCLUSIONS: A higher incidence of structural malformations was seen with MMF exposures during pregnancy compared to the overall kidney transplant recipient offspring, while no structural defects have as yet been reported with early pregnancy sirolimus exposures. Centers are encouraged to report all pregnancy exposures in transplant recipients.

Abnormalities, Drug-Induced↗

Patterns of volunteerism, testing, and exclusion among potential living kidney donors.

We found that in kidney transplantation, more females donate. We analyzed transplant recipients for patterns of potential donor exclusion and found that equal proportions of male and female potential donors existed among first-degree biological relatives. More male recipients were married and therefore had more spousal potential donors. Among friends and non-first-degree relatives, significantly fewer males offered to donate to females. Equal proportions of female and male potential donors were excluded from donating for medical comorbidities, blood type incompatibility, recipient refusal, and potential donor reluctance. We concluded that female transplant candidates had fewer potential donors among spouses and opposite sex volunteers from friends and non-first-degree relatives.

Adult↗

Reproduction and transplantation: report on the AST Consensus Conference on Reproductive Issues and Transplantation.

It has been almost 50 years since the first child was born to a female transplant recipient. Since that time pregnancy has become common after transplantation, but physicians have been left to rely on case reports, small series and data from voluntary registries to guide the care of their patients. Many uncertainties exist including the risks that pregnancy presents to the graft, the patient herself, and the long-term risks to the fetus. It is also unclear how to best modify immunosuppressive agents or treat rejection during pregnancy, especially in light of newer agents available where pregnancy safety has not been established. To begin to address uncertainties and define clinical practice guidelines for the transplant physician and obstetrical caregivers, a consensus conference was held in Bethesda, Md. The conferees summarized both what is known and important gaps in our knowledge. They also identified key areas of agreement, and posed a number of critical questions, the resolution of which is necessary in order to establish evidence-based guidelines. The manuscript summarizes the deliberations and conclusions of the conference as well as specific recommendations based on current knowledge in the field.

Female↗

Report from the National Transplantation Pregnancy Registry (NTPR): outcomes of pregnancy after transplantation.

The NTPR maintains an ongoing active database to study the safety of pregnancy in transplant recipients and currently includes the outcomes of more than 900 female recipients who became pregnant after their transplant and just over 700 male recipients who fathered one or more pregnancies after receiving a transplant. Analyses include the long-term follow-up of the recipient's graft status and their offspring. Successful pregnancy outcomes have been noted for each solid organ recipient group. The Registry includes information on 1,097 pregnancies in 716 kidney recipients, 187 pregnancies in 111 liver recipients, 56 pregnancies in 38 P/K recipients and smaller numbers for other organs and combinations of organs. There are periodic reports of recipients with graft dysfunction, rejection, or graft loss that may be related to pregnancy events, though the majority of outcomes reported to the NTPR appear favorable for parent and newborn. Organ-specific issues and comorbidities must also be considered in analyzing outcomes. The pregnancy issues that face recipients and caretakers with the current newer adjunctive therapies and newer immunosuppressive regimens require ongoing study. The potential risk of teratogenicity must be weighed against the potential risk of rejection when altering drug regimens before planned conceptions or in making dosage adjustments during pregnancy. Unplanned pregnancies present obvious concerns. Pregnancy safety has not been established for either MMF or sirolimus and all centers are encouraged to report pregnancies with exposures to these agents to the NTPR. Continuing analyses are directed at potential effects of the newer immunosuppressive regimens, not only to identify any risks to the pregnancy from immediate exposure, but also for potential postpartum exposures such as from breastfeeding. As the registry study design allows for continued contact, efforts continue to accrue long-term follow-up of both parent and child.

Breast Feeding↗

Pregnancy in female pediatric solid organ transplant recipients.

This article from the National Transplantation Pregnancy Registry (NTPR) describes the pregnancy outcomes of female transplant recipients who received a solid organ transplant when younger than 21 years old. The analysis includes kidney, liver, liver-kidney, heart, and lung recipients. No recipients in the registry received a pancreas-kidney or heart-lung transplant before age 21. To date, the NTPR has not received report of a pregnancy in a small bowel recipient. This article also reviews immunosuppressive medications with regard to pregnancy safety.

Adult↗

Pregnancy outcomes in female renal recipients: a comparison of systemic lupus erythematosus with other diagnoses.

This study compares pregnancy outcomes in systemic lupus erythematosus (SLE) patients post renal transplant with recipients with other primary diagnoses, utilizing data from the National Transplantation Pregnancy Registry, Philadelphia, PA. Recipients were referred from transplant centers nationwide. A retrospective analysis was performed using data from questionnaires, hospital records and telephone interviews. Outcomes of pregnancies post renal transplant secondary to lupus nephritis (SLE: n = 38; 60 pregnancies) were compared with the pregnancy outcomes of renal recipients with other diagnoses (non-SLE: n = 247; 374 pregnancies). Drug-treated hypertension during pregnancy was less common in the SLE group than in the non-SLE group (45.0% vs. 62.5%, p = 0.015). There were fewer cesarean sections in the SLE group (30.2 vs. 53.2%, p = 0.008). There was no primary or gestational diabetes in the SLE group. There were no other statistical differences in maternal conditions or pregnancy outcomes between the SLE and non-SLE groups, or in the incidence of post pregnancy graft loss. Female recipients transplanted for renal failure secondary to lupus nephritis can successfully maintain pregnancy. Outcomes are comparable to renal recipients with other diagnoses. Newborns in both groups were often premature and had low birthweight. Overall childhood health was reported to be good; there were no apparent predominant structural malformations among the children.

Female↗

Report from the National Transplantation Pregnancy Registry (NTPR): outcomes of pregnancy after transplantation.

The NTPR continues to maintain an ongoing active database as a resource for health professionals counseling recipients regarding pregnancy and for recipients themselves to contact the registry and request information. This includes female transplant recipients as well as male recipients who father pregnancies. Recipients who consent are entered into a database; analyses are ongoing, including long-term follow-up of the recipient, the graft and the offspring. The safety of pregnancy for parent and child remains the goal of the registry. Guidelines for counseling recipients proposed in 1976 remain applicable. Recipients should be in general good health and graft function should be stable and ideally rejection free. Comorbid conditions should be well controlled, especially hypertension and diabetes. While these counseling guidelines were formulated for kidney recipients, they may be extrapolated for other organ recipients. Analyses this year included pregnancy outcomes of recipients on newer agents, MMF and sirolimus. It remains unclear whether these adjunctive therapies should be altered for pregnancy. The balance of immunosuppression and the prevention of rejection need to be weighed against the potential for teratogenicity when counseling these recipients inquiring about pregnancy. Although there are periodic reports of recipients with graft dysfunction, rejection or graft loss possibly related to pregnancy events throughout all the organ groups, whether transplanted as adults or as pediatric patients, the majority of pregnancy outcomes reported to the NTPR appear favorable for parent and newborn. Whether recipients should breastfeed remains controversial. Recent reports in the literature as well as NTPR data appear favorable. This represents the last report from our initial established location at Thomas Jefferson University. In January of this year, the registry moved to Temple University School of Medicine, Department of Surgery, Philadelphia, PA. The NTPR remains committed to investigating outcomes of pregnancies reported by centers or self-referrals nationwide. Some of the active issues for the upcoming year include the potential for teratogenicity with combinations of newer agents, incidence of viral hepatitis, risk assessment for pregnancy in female lung recipients, and long-term maternal and pediatric follow-up.

Breast Feeding↗

Immunosuppression in pregnancy: choices for infant and maternal health.

Successful pregnancy outcomes are possible after all types of solid organ transplantation and thousands of successful pregnancies in such women have been reported. As immunosuppressive medications are required to maintain adequate graft and maternal survival, major concerns are the effect of these agents on the fetus and the effect of pregnancy on the well being of mother and graft, against a background of continuing advances and modifications in immunosuppressive therapy. Women should avoid unnecessary medications during pregnancy but clinicians worry most about teratogens; agents (environmental, pharmaceuticals or other chemicals) that cause abnormal development, whether this be an overt structural birth defect or more subtle derangements of embryonic or fetal development. A concern is that any agent or combination of agents and maternal condition(s) may be teratogenic, a risk that is increased in the transplant population. The goal of immunosuppression is to ensure graft and patient survival by preventing acute rejection. Combinations of agents allow for synergistic effects while minimising drug toxicities. No specific combination has been deemed optimal and the effects of more recently available combinations require further study. Although there are known theoretical risks to mother and fetus, successful pregnancies are now the rule in transplant recipients. This is without an apparent increase in the type or incidence of malformations in the newborns, and usually with no evidence of graft dysfunction and/or irreversible deterioration either related to prepregnancy graft problems or unpredictable gestational factors. For immunosuppression, what is best for the mother and her survival should ensure the best outcome for the fetus and, although no specific malformation pattern has been reported to date, there are some interesting trends worthy of continued analyses. A balance of good maternal and graft outcome with the lowest risk of fetal toxicity must be the goal of management.

Abnormalities, Drug-Induced↗

Report from the National Transplantation Pregnancy Registry (NTPR): outcomes of pregnancy after transplantation.

The NTPR maintains an ongoing database to study the outcomes of pregnancies in female transplant recipients as well as those pregnancies fathered by male transplant recipients. Recipients are entered into the database by completing. a single page questionnaire. There is steady follow-up of recipients and their offspring. While the majority of pregnancy outcomes have occurred in kidney recipients, data continue to accrue in the other types of organ recipients. KIDNEY: A small percentage of pregnancies in female kidney recipients are complicated by rejection with poorer outcomes with respect to both maternal graft function and their newborn. Other analyses this year focused on outcomes of recipients with systemic lupus erythematosus and those with multiple gestations. It was observed that recipients with systemic lupus erythematosus were able to maintain a pregnancy with outcomes that appear to be similar to other diagnoses. In an analysis of multiple gestations in female kidney recipients maintained on calcineurin inhibitors, no multiple gestations higher than triplets have been reported to the NTPR. Successful outcomes have been noted among these recipients. This does require continued surveillance, as there has been an increase in the number of multiple gestations in the general population with the use of adjunctive technologies. OTHER ORGANS: In analyzing outcomes in female liver recipients, no specific graft or newborn outcome differences have been noted when a comparison has been made between different caicineurin inhibitor regimens. Pregnancies in female pancreas-kidney recipients appear to be tolerated with respect to pancreas graft function with no diagnoses of gestational diabetes reported to the NTPR. Data continue to accrue among thoracic recipients. Poorer maternal survival postpartum in lung recipients may be related to higher risks inherent in this population and requires further experience and investigation. OTHER ISSUES: With the recent proliferation of newer immunosuppressive agents, a question that is raised is whether a regimen can be specifically designed with recipients of childbearing age in mind. Extensive data published on azathioprine and cyclosporine treated recipients suggests that while there is a pattern of prematurity among the newborn there has not been an increase in the incidence or pattern of specific malformations noted among the newborn. Less assurance can be given with newer agents such as sirolimus and MMF. Calcineurin inhibitor minimization or steroid withdrawal would require that other agents with less reproductive information be implemented. The unknown risk of teratogenicity must be balanced against the potential risk of rejection or graft dysfunction when deciding which agent to use during pregnancy. Through each of the organ recipient groups, there are sporadic cases of rejection, graft dysfunction, and graft deterioration. Birth defect patterns have not appeared to be specific to any specific regimen as yet. Two newborns with malformations have been noted among a limited series with MMF exposure, but other factors may also be at play. The use of MMF during pregnancy continues to be an unresolved issue in the transplant community. As yet, no one regimen has been identified as superior to another for use during pregnancy. Continued surveillance with the newer agents is necessary. Investigators have taken differing views regarding the safety of breastfeeding in the transplant recipient population, especially with regard to drug exposure to the infant. This issue remains unresolved and some transplant recipient mothers have chosen to breastfeed. Other factors for consideration are the potential long-term effects on offspring of transplant recipients. While there may not be specific structural defects noted at birth, more subtle effects on either immunologic or reproductive function may not manifest until later in life. Scott and his group in Utah have raised this issue with a case report and have initiated a study to focus on the next generation. The safety of pregnancy for parent and child remain the goals of the NTPR. Continued entries to the registry, especially in light of newer combinations of immunosuppressive agents, should assist in developing guidelines needed for management in this era of expanding immunosuppressive agents. All centers are encouraged to participate.

Creatinine↗