Registries

BackgroundYounger patients (18-49 years of age) with advanced heart failure (HF) face unique challenges in decision-making for advanced HF therapies. Although heart transplantation (HT) offers excellent survival, it is associated with finite graft longevity. The HeartMate 3 (HM3) left ventricular assist device (LVAD) has demonstrated promising outcomes, but direct comparisons with those listed for or undergoing HT in this age group remain limited.ObjectivesThis study sought to compare survival and adverse event (AE) outcomes between younger patients receiving HM3 LVAD support and those listed for or undergoing HT.MethodsThe authors analyzed patients 18-49 years of age from the MOMENTUM 3 (Multicenter Study of MagLev Technology in Patients Undergoing Mechanical Circulatory Support Therapy with HeartMate 3) portfolio (HM3 cohort; n = 420) and the UNOS (United Network for Organ Sharing) registry (HT listing cohort; n = 1,955) (HT recipients; n = 1,176) from 2014-2018. Propensity score matching was performed to adjust for baseline differences. Outcomes included 2-year survival from time of treatment or time of listing, freedom from death or delisting for deterioration, and 1-year incidence of major AEs (ie, stroke, renal dysfunction, infection).ResultsAfter propensity score matching, 2-year survival from treatment was similar for HM3 and HT (88.7% vs 90.2%; HR: 1.18; P = 0.53). When comparing outcomes from time of transplant listing vs LVAD implantation, HM3 was associated with higher freedom from death compared with freedom from death or delisting due to deterioration in UNOS (90.1% vs 76.7%; HR: 0.38; P ConclusionsContemporary data suggest that durable LVAD therapy may offer survival outcomes comparable to HT in adults <50 years of age. These findings support the consideration of an LVAD-first strategy as a viable initial approach to heart replacement therapy in appropriately selected patients. (Multicenter Study of MagLev Technology in Patients Undergoing Mechanical Circulatory Support Therapy with HeartMate 3 Investigational Device Exemption [MOMENTUM 3 IDE]; NCT02224755) (MOMENTUM 3 Continued Access Protocol [MOMENTUM 3 CAP]; NCT02892955).

Study questionWhat have been the activities, characteristics, and outcomes of uterus transplantation (UTx) performed worldwide from 2000 through 2024?Summary answerIn 91 UTx cases, 67 involved live donors and 80 of the recipients had Mayer-Rokitansky-Küster-Hauser syndrome, with 12-month graft survival of 74%, enabling pregnancy attempts that yielded 44 healthy singleton deliveries with a live birth rate per embryo transfer of 30.3%.What is known alreadyUTx is the only treatment for women with absolute uterine factor infertility who wish to carry a pregnancy. According to a comprehensive report including data up to 2020 on 45 UTx cases, 19 live births occurred (35.8% per embryo transfer) at a mean of 35.3 weeks gestation.Study design, size, durationData were extracted from the web-based registry of the International Society of Uterus Transplantation (ISUTx). This registry captures information on donor and recipient characteristics, transplantation procedures, postoperative complications, immunosuppression, complications including rejections, and reproductive outcome. Analyses were undertaken of the 91 transplants performed between 6 April 2000 and 31 December 2024, that were recorded in the registry.Participants/materials, setting, methodsTwenty-four medical centers in five continents registered their uterus transplants by entering data from the day of transplantation until 3 months after graft removal. The following variables were assessed: the demographic and laboratory characteristics of donors and recipients, the source of graft (live versus deceased donor), surgical specifics including technique, duration, ischemic times, and post-op complications, immunosuppression, rejection data, pregnancy with live birth(s), and hysterectomy.Main results and the role of chanceIn 91 uterus transplantations (67 from live donors, 24 from deceased donors), the overall surgical success rate, defined as graft viability by 12 months, was 75%. Most recipients (88%) had Mayer-Rokitansky-Küster-Hauser syndrome, with mothers being the most frequent (64%) live donors. Live donor hysterectomies were performed by laparotomy (54%), robotics (28%), or laparoscopy (18%). Total ischemic time was shorter in live- versus deceased-donor UTx procedures. Rejection episodes that were treated with escalations of immunosuppression were more frequent during months 1-5 (44%) than during months 6-10 (28%) post-UTx. Graft survival during the first 12 months was superior when grafts from premenopausal donors were used as compared to from postmenopausal donors. Forty-four singleton live births (mean gestational length of 34.5 weeks), including eight second births, were reported, with a live birth rate per embryo transfer of 30%. Preeclampsia was the most common pregnancy complication, occurring in 23% of live-birth pregnancies. Major postnatal complications occurred in 11 infants, 9 with respiratory distress syndrome; no major malformations were observed.Limitations, reasons for cautionData in the registry are self-reported and not subjected to validation. Although the ISUTx registry represents the most comprehensive quality registry of UTx activity in the world, cases from at least four centers are excluded as they were not entered into the registry. Birth outcomes from some registry cases are as yet unknown as these ongoing cases have not yet reached the endpoint of hysterectomy.Wider implications of the findingsThis study presents the most comprehensive analysis to date of UTx, the only fertility treatment for absolute uterine factor infertility. The registry serves as the prime source for quality assessment and process improvement in UTx.Study funding/competing interest(s)The establishment and operation of the registry were funded by the Swedish Research Council (2024-03487 to M.B.) and Jane and Dan Olsson Foundation (2024-11 to M.B.). There was no competing interest.Trial registration numberNot applicable.

BackgroundIntensive care unit registries, which aim to improve the quality of intensive care unit care through benchmarking and quality improvement initiatives, are active worldwide, with considerable dishomogeneity. We aimed to map core datasets, additional variables, and research activities of these registries.MethodsA cross-sectional survey was disseminated to registry leads between October 2023 and June 2024. The survey was structured into four main topics: registry characteristics and coverage, core dataset features, additional modules, and registry-enabled research.ResultsLeads of 34/42 national registries responded (response rate 81%), covering 3,337 intensive care units, with a larger representation from South America. Systematized nomenclature of medicine, clinical terms, and customized categorical classifications were the main nomenclatures used. All registries except one employed a severity of illness score/risk prediction model. The SOFA score was reported by 88% of registries. Organ support measures were often recorded, including mechanical ventilation (97%), vasopressor administration (86%) and renal replacement therapy (86%). Three out of four intensive care unit registries coded interventions such as intubations, intravenous lines and tracheostomies. Additional datasets differed, with many use cases for nosocomial infection burden, bed availability and staffing resources. Over half of intensive care unit registries had current structured quality improvement initiatives. Registry-enabled observational research was reported in 46% of registries, while interventional studies were reported in only 22%.ConclusionOver three thousand intensive care units in 35 countries participate in an intensive care unit registry. Despite heterogeneity in coding systems, risk models, and additional datasets, we identify several areas of convergence that may inform a future shared core dataset. There is potential for further intensive care unit registry-based research, particularly interventional.