Three-year outcomes of de novo tacrolimus extended-release tablets (LCPT) compared to twice-daily tacrolimus in adult heart transplantation.

BACKGROUND: Extended-release tacrolimus for prophylaxis of allograft rejection in heart transplant (HT) recipients is currently not FDA-approved. One such extended-release formulation of tacrolimus known as LCPT allows once-daily dosing and improves bioavailability compared to immediate-release (IR-) tacrolimus. We compared long-term efficacy and safety of LCPT to IR-tacrolimus applied de novo in adult OHT recipients. METHODS: 25 prospective recipients on LCPT at our center from 2017 to 2019 were matched 1:2 with historical control recipients treated with IR-tacrolimus based on age, gender, and baseline creatinine. The primary composite outcome of death, acute cellular rejection, and/or new graft dysfunction within 3 years following transplant was compared between groups using non-inferiority analysis. RESULTS: LCPT demonstrated non-inferiority to IR-tacrolimus, with a primary outcome risk reduction of 16% (90%CI, -37%, -1%, non-inferiority p = 0.002) up to 3 years following heart transplant. Up to 3-years post-transplant, 14 patients remained on once-daily LCPT and 10 patients were switched to IR-tacrolimus due to lack of insurance coverage. There were no significant differences in the rate of chronic kidney disease requiring dialysis, cytomegalovirus requiring treatment, cardiac allograft vasculopathy, and malignancy within 3 years following transplant. CONCLUSION: LCPT is non-inferior in efficacy to IR-tacrolimus in heart transplantation with a similar safety profile. Narrowly-constrained FDA labels specific to kidney transplant remain a barrier to consistent access to many immunosuppressant medications for recipients of non-kidney solid organs. We recommend the FDA consider developing facile pathways for expanding the approved label of extended-release tacrolimus formulations to heart transplant recipients.

Nuclear and chloroplast DNA phylogeography reveals high genetic diversity and postglacial range expansion in Quercus mexicana.

PREMISE: Phylogeographical studies are fundamental for understanding factors that influence the spatial distribution of genetic lineages within species. Population expansions and contractions, distribution shifts, and climate changes are among the most important factors shaping the genetic compositions of populations. METHODS: We investigated the phylogeography of an endemic oak, Quercus mexicana (Fagaceae), which has a restricted distribution in northeastern Mexico along the Sierra Madre Oriental and adjacent areas. Nuclear and chloroplast DNA microsatellite markers were used to describe the genetic diversity and structure of 39 populations of Q. mexicana along its entire distribution area. We tested whether population expansion or contraction events influenced the genetic diversity and structure of the species. We also modeled the historical distributional range of Q. mexicana (for the Mid Holocene, the Last Glacial Maximum, and the Last Interglacial) to estimate the extent to which climate fluctuations have impacted the distribution of this oak species. RESULTS: Our results revealed high genetic diversity and low genetic structure in Q. mexicana populations. Ecological niche models suggested historical fluctuations in the distributional range of Q. mexicana. Historical range changes, gene flow, and physical barriers seem to have played an important role in shaping the phylogeographic structure of Q. mexicana. CONCLUSIONS: Our study indicates that the genetic structure of Q. mexicana may have been the result of responses of oak trees not only to heterogeneous environments present in the Sierra Madre Oriental and adjacent areas, but also to elevational and latitudinal shifts in response to climate changes in the past.

HeartMate 3 Explantation Using Felt Plug for Ventriculotomy Occlusion.

Left ventricular assist devices (LVAD) can be utilized for heart failure patients as a bridge to transplant, bridge to destination, or bridge to recovery. Given the lack of a universally accepted consensus for assessing myocardial recovery, techniques and strategies in LVAD explantation also vary. In addition, the incidence of LVAD explantation remains relatively low, and surgical techniques of explantation continue to be areas of interest. Our approach using a felt-plug Dacron technique is an effective way to preserve left ventricular geometry and cardiac function.

Prediction of Survival After Implantation of a Fully Magnetically Levitated Left Ventricular Assist Device.

BACKGROUND: Clinical trials inform on average efficacy, but individualized risk assessments for outcome prediction are important in guiding treatment implementation. OBJECTIVES: The authors developed and validated a patient-specific risk score to predict survival at 1 and 2 years after HeartMate 3 (HM3) left ventricular assist device (LVAD) implantation. METHODS: The MOMENTUM 3 (Multicenter Study of MagLev Technology in Patients Undergoing Mechanical Circulatory Support Therapy with HeartMate 3) trial includes 2,200 HM3 LVAD patients in the pivotal trial and Continued Access Protocol study (2014-2018). The authors randomly assigned all patients to a derivation cohort (n = 1,540) or validation cohort (n = 660). Univariate mortality predictors were screened for potential model inclusion, stepwise selection was used to build the multivariable Cox proportional hazards regression model, and performance (discrimination and calibration) was evaluated. RESULTS: Age, prior cardiac surgery (coronary artery bypass grafting [CABG] or valve procedure), lower serum sodium, higher blood urea nitrogen (BUN), small left ventricular size, and right atrial pressure-to-pulmonary capillary wedge pressure (RAP/PCWP) ratio >0.6 were significant risk factors for mortality. Receiver-operating characteristic (ROC) analysis in the validation cohort demonstrated an area under the curve (AUC) of 0.76 (95% CI: 0.70-0.81) at 1 year and 0.71 (95% CI: 0.66-0.77) at 2 years. Calibration between predicted and observed survival of the risk quintiles was high, with Pearson correlation coefficients of 0.986 and 0.994 at 1 and 2 years, respectively. Patients were successfully stratified into tertiles with higher-than-average, average, and lower-than-average survival, and observed mortality risk increased by 2-fold from one tertile to the next. CONCLUSIONS: A practical, easy-to-use HM3 Survival Risk Score with 6 components was developed to accurately predict 1- and 2-year survival after HM3 LVAD implantation. The survival risk score can be used to provide individual survival estimates to facilitate shared decision making when considering HM3 LVAD therapy. (MOMENTUM 3 Trial Portfolio; NCT02224755, NCT02892955).

Fusion of Bovine Tissue Aortic Valve Leaflets in a Patient With Left Ventricular Assist Device.

Patients with both a prosthetic aortic valve and prolonged left ventricular assist device support can develop rapid deterioration of their valve prosthesis. In patients with myocardial recovery who are undergoing explantation of their ventricular assist device, preoperative and intraoperative evaluation of the valve prosthesis should be performed to ensure adequate function. (Level of Difficulty: Advanced.).

Management of cardiac diseases in liver transplant recipients: Comprehensive review and multidisciplinary practice-based recommendations.

Cardiac diseases are one of the most common causes of morbidity and mortality following liver transplantation (LT). Prior studies have shown that cardiac diseases affect close to one-third of liver transplant recipients (LTRs) long term and that their incidence has been on the rise. This rise is expected to continue as more patients with advanced age and/or non-alcoholic steatohepatitis undergo LT. In view of the increasing disease burden, a multidisciplinary initiative was developed to critically review the existing literature (between January 1, 1990 and March 17, 2021) surrounding epidemiology, risk assessment, and risk mitigation of coronary heart disease, arrhythmia, heart failure, and valvular heart disease and formulate practice-based recommendations accordingly. In this review, the expert panel emphasizes the importance of optimizing management of metabolic syndrome and its components in LTRs and highlights the cardioprotective potential for the newer diabetes medications (e.g., sodium glucose transporter-2 inhibitors) in this high-risk population. Tailoring the multidisciplinary management of cardiac diseases in LTRs to the cardiometabolic risk profile of the individual patient is critical. The review also outlines numerous knowledge gaps to pave the road for future research in this sphere with the ultimate goal of improving clinical outcomes.

Importance of right heart catheterization in advanced heart failure management.

Patients with chronic congestive heart failure belong to a population with reduced quality of life, poor functional class, and increased risk of mortality and morbidity. In these patients, assessment of invasive hemodynamics both serves therapeutic purposes and is useful for stratification roles. The right heart catheterization has become a cornerstone diagnostic tool for patients in refractory heart failure or cardiogenic shock, as well as for the assessment of candidacy for heart replacement therapies, and the management of patients following mechanical circulatory assist device implantation and heart transplantation.

Angiotensin II: A Multimodal Approach to Vasoplegia in a Cardiac Setting.

Patients experiencing vasoplegia, a type of distributive shock, have limited options when conventional vasopressors are not appropriate or sufficient. This is especially true for patients with cardiac dysfunction, whether after heart transplant or ventricular assist device (VAD) implantation. Angiotensin II has been used in various clinical settings for distributive shock; however, its role in patients after orthotopic heart transplant or VAD implantation is not well studied. We present two cases where angiotensin II played a vital role in correcting vasoplegia for critical cardiac patients.

De novo tacrolimus extended-release tablets (LCPT) versus twice-daily tacrolimus in adult heart transplantation: Results of a single-center non-inferiority matched control trial.

Extended-release tacrolimus for prophylaxis of allograft rejection in orthotopic heart transplant (OHT) recipients is currently not FDA-approved. One such extended-release formulation of tacrolimus known as LCPT allows once-daily dosing and improves bioavailability compared to immediate-release tacrolimus (IR-tacrolimus). We compared the efficacy and safety of LCPT to IR-tacrolimus applied de novo in adult OHT recipients. Twenty-five prospective recipients on LCPT at our center from 2017 to 2019 were matched 1:2 with historical control recipients treated with IR-tacrolimus based on age, gender, and baseline creatinine. The primary composite outcome of death, acute cellular rejection, and/or new graft dysfunction within 1 year was compared using non-inferiority analysis. LCPT demonstrated non-inferiority to IR-tacrolimus, with a primary outcome risk reduction of 20% (90% CI: -40%, -.5%; non-inferiority P = .001). Tacrolimus trough levels peaked at 2-3 months and were higher in LCPT (median 14.5 vs. 12.7 ng/ml; P = .03) with similar dose levels (LCPT vs. IR-tacrolimus: .08 vs. .09 mg/kg/day; P = .33). Cardiovascular-related readmissions were reduced by 62% (P = .046) in LCPT patients. The complication rate per transplant admission and all-cause readmission rate did not differ significantly. These results suggest that LCPT is non-inferior in efficacy to IR-tacrolimus with a similar safety profile and improved bioavailability in OHT.

Unexpected Twists: A 61-Year-Old Male with Repeated HeartMate II Complications andSubsequent Replacement with HeartMate III.

An outflow graft twist of a left ventricular assist device (LVAD) remains a challenging clinical diagnosis and may even be misdiagnosed for other outflow obstructions. We present a case of a patient with two LVAD exchanges due to suspected outflow graft twisting in both clinical scenarios. As new LVADs continue to be designed and upgraded, clinicians must have a high index of suspicion for this rare complication.

Perioperative central venous oxygen saturation and its correlation with mortality during cardiac surgery: an observational prospective study / Correlação entre saturação venosa central de oxigênio perioperatória e mortalidade em cirurgia cardíaca: estudo prospectivo observacional

Abstract Background: Cardiac surgery can produce persistent deficit in the ratio of Oxygen Delivery (DO2) to Oxygen Consumption (VO2). Central venous oxygen Saturation (ScvO2) is an accessible and indirect measure of DO2/VO2 ratio. Objective: To monitor perioperative ScvO2 and assess its correlation with mortality during cardiac surgery. Methods: This prospective observational study evaluated 273 patients undergoing cardiac surgery. Blood gas samples were collected to measure ScvO2 at three time points: T0 (after anesthetic induction), T1 (end of surgery), and T2 (24 hours after surgery). The patients were divided into two groups (survivors and nonsurvivors). The following outcomes were analyzed: intrahospital mortality, length of Intensive Care Unit (ICU) and hospital stay (LOS), and variation in ScvO2. Results: Of the 273 patients, 251 (92%) survived and 22 (8%) did not. There was a significant perioperative reduction of ScvO2 in both survivors (T0 = 78% ± 8.1%, T1 = 75.4% ± 7.5%, and T2 = 68.5% ± 9%; p< 0.001) and nonsurvivors (T0 = 74.4% ± 8.7%, T1 = 75.4% ± 7.7%, and T2 = 66.7% ± 13.1%; p < 0.001). At T0, the percentage of patients with ScvO2< 70% was greater in the nonsurvivor group (31.8% vs. 13.1%; p= 0.046) and the multiple logistic regression showed that ScvO2 is an independent risk factor associated with death, OR = 2.94 (95% CI 1.10−7.89) (p= 0.032). The length of ICU and LOS were 3.6 ± 3.1 and 7.4 ± 6.0 days respectively and was not significantly associated with ScvO2. Conclusions: Early intraoperative ScvO2 < 70% indicated a higher risk of death. A perioperative reduction of ScvO2 was observed in patients undergoing cardiac surgery, with high intraoperative and lower postoperative levels.

Resumo Justificativa: A cirurgia cardíaca pode produzir déficit persistente na razão entre oferta de oxigênio (DO2) e consumo de oxigênio (VO2). A Saturação venosa central de Oxigênio (SvcO2) é uma medida acessível e indireta da razão DO2/VO2. Objetivo: Monitorar a SvcO2 perioperatória e avaliar sua correlação com a mortalidade em cirurgia cardíaca. Método: Este estudo observacional prospectivo avaliou 273 pacientes submetidos a cirurgia cardíaca. Coletamos amostras de sangue para medir a SvcO2 em três momentos: T0 (após indução anestésica), T1 (final da cirurgia) e T2 (24 horas após a cirurgia). Os pacientes foram divididos em dois grupos (sobreviventes e não sobreviventes). Os seguintes desfechos foram analisados: mortalidade intra-hospitalar, tempo de permanência na Unidade de Terapia Intensiva (UTI) e de internação hospitalar, e variação na SvcO2. Resultados: Dos 273 pacientes, 251 (92%) sobreviveram e 22 (8%) não. Houve queda significante da SvcO2 perioperatória nos sobreviventes (T0 = 78% ± 8,1%, T1 = 75,4% ± 7,5% e T2 = 68,5% ± 9%; p< 0,001) e nos não sobreviventes (T0 = 74,4% ± 8,7%, T1 = 75,4% ± 7,7% e T2 = 66,7% ± 13,1%; p< 0,001). No T0, a porcentagem de pacientes com SvcO2< 70% foi maior no grupo não sobrevivente (31,8% vs. 13,1%; p = 0,046) e a regressão logística múltipla mostrou que a SvcO2 é um fator de risco independente associado ao óbito, OR = 2,94 (95% IC 1,10 − 7,89) (p = 0,032). O tempo de permanência na UTI e de hospitalização foi de 3,6 ± 3,1 e 7,4 ± 6,0 dias, respectivamente, e não foi significantemente associado à SvcO2. Conclusões: Valores precoces de SvcO2 intraoperatória < 70% indicaram maior risco de óbito em pacientes submetidos à cirurgia cardíaca. Observamos redução perioperatória da SvcO2, com altos níveis no intraoperatório e mais baixos no pós-operatório.

[Perioperative central venous oxygen saturation and its correlation with mortality during cardiac surgery: an observational prospective study]. / Correlação entre saturação venosa central de oxigênio perioperatória e mortalidade em cirurgia cardíaca: estudo prospectivo observacional.

BACKGROUND: Cardiac surgery can produce persistent deficit in the ratio of Oxygen Delivery (DO2) to Oxygen Consumption (VO2). Central venous oxygen Saturation (ScvO2) is an accessible and indirect measure of DO2/VO2 ratio. OBJECTIVE: To monitor perioperative ScvO2 and assess its correlation with mortality during cardiac surgery. METHODS: This prospective observational study evaluated 273 patients undergoing cardiac surgery. Blood gas samples were collected to measure ScvO2 at three time points: T0 (after anesthetic induction), T1 (end of surgery), and T2 (24hours after surgery). The patients were divided into two groups (survivors and nonsurvivors). The following outcomes were analyzed: intrahospital mortality, length of Intensive Care Unit (ICU) and hospital stay (LOS), and variation in ScvO2. RESULTS: Of the 273 patients, 251 (92%) survived and 22 (8%) did not. There was a significant perioperative reduction of ScvO2 in both survivors (T0=78%± 8.1%, T1=75.4%±7.5%, and T2=68.5%±9%; p<0.001) and nonsurvivors (T0=74.4%±8.7%, T1=75.4%±7.7%, and T2=66.7%±13.1%; p <0.001). At T0, the percentage of patients with ScvO2 <70% was greater in the nonsurvivor group (31.8% vs. 13.1%; p=0.046) and the multiple logistic regression showed that ScvO2 is an independent risk factor associated with death, OR=2.94 (95% CI 1.10-7.89) (p=0.032). The length of ICU and LOS were 3.6±3.1 and 7.4±6.0 days respectively and was not significantly associated with ScvO2. CONCLUSIONS: Early intraoperative ScvO2 <70% indicated a higher risk of death. A perioperative reduction of ScvO2 was observed in patients undergoing cardiac surgery, with high intraoperative and lower postoperative levels.

The COVID-19 pandemic: A community approach.

An unprecedented global pandemic caused by a novel coronavirus, Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) has quickly overwhelmed the health care systems worldwide. While there is an absence of consensus among the community in how to manage solid organ transplant recipients and donors, a platform provided by the American Society of Transplantation online community "Outstanding Questions in Transplantation," hosted a collaborative multicenter, multinational discussions to share knowledge in a rapidly evolving global situation. Here, we present a summary of the discussion in addition to the latest published literature.

Cardiogenic Shock in Patients with Advanced Chronic Heart Failure.

Patients with end-stage heart failure (HF) who have failed optimal medical therapy provide a unique set of challenges compared to the more prevalent population of patients with cardiogenic shock (CS) due to ST-segment elevation myocardial infarction. Progression from "preshock" into a refractory state of CS is associated with a dismal outcome due to difficulties with the patient's recognition, response to interventions, and candidacy for salvage options. Challenges include heterogeneity of CS (eg, different phenotypes, etiologies, duration, acuity of onset, hemodynamics, end-organ effects), lack of a universal definition of CS that is applicable to this patient population, and blunted hemodynamic response given the patient's prolonged compensatory state. Individuals with advanced HF in CS require a multidisciplinary team-based assessment regarding when to escalate from medical therapy into temporary mechanical circulatory support, and they need an eligibility evaluation to determine their candidacy for advanced therapy. In this review, we discuss the definition and clinical phenotypes of CS, classification of CS in advanced HF patients, the utility of temporary mechanical circulatory support, and the role of the CS team.

Acute Isolated Coronary Artery Dissection Causing Massive Acute Myocardial Infarction and Leading to Unsuccessful Coronary Bypass, Extracorporeal Life Support, and Successful Cardiac Transplantation.

Described herein is a 42-year-old woman who suddenly developed a spontaneous isolated coronary arterial dissection which led to massive acute myocardial infarction with shock, unsuccessful coronary artery bypass grafting, transiently successful extracorporeal life support, and finally successful heart transplant. Such a sequence of events is exceedingly rare for patients with coronary dissection and prompted this report.

Cardiac catheterization and percutaneous intervention procedures on extracorporeal membrane oxygenation support.

Extracorporeal membrane oxygenation (ECMO) is used to support critically ill patients when conventional therapies have failed. ECMO has been available for four decades and has gained use as a rescue therapy in severe refractory hypoxic disorders and in patients with refractory cardiogenic shock (RCS). Over recent years, several percutaneous cardiac interventions and implant devices have been developed that are now used frequently in conjunction with ECMO in order to maintain organ perfusion. Here, we review the literature on VA-ECMO cannulation location, the use of VA-ECMO in interventions (e.g., coronary interventions and structural heart interventions) and percutaneous cardiac device implantation in VA-ECMO recipients with RCS.

Fatores que influenciam a percepção do paciente quanto a qualidade de recuperação pós-operatória / Factors influencing the patient's perception of the quality of postoperative recovery / Factores que influencian la percepción del paciente cuanto la calidad de recuperación postoperatoria

Objetivo: a satisfação do paciente é um conceito complexo e multifatorial que ganhou muita importância nas últimas décadas, através dos processos de acreditação. Além disso, a satisfação do paciente influencia o relacionamento com a equipe multidisciplinar e, até mesmo, a adesão ao tratamento proposto. A percepção do paciente quanto à qualidade de recuperação pós-operatória é um dos componentes que influenciam essa satisfação. O objetivo dessa revisão foi avaliar os fatores relacionados ao ato anestésico e cirúrgico que interferem na percepção do paciente quanto à qualidade de recuperação pós-operatória. Método: durante o período entre 01 de março e 31 julho de 2018, a presente revisão integrativa pesquisou os descritores nas bases de dados e encontrou 52000 citações de artigos publicados entre janeiro de 2011 e julho de 2018. Através dos operadores booleanos, combinaram-se os termos da pesquisa e excluíram-se os artigos duplicados; 256 artigos foram avaliados e 51 foram selecionados para essa revisão. Conclusão: a utilização de medicamentos e técnicas que minimizem a permanência hospitalar ou evitem efeitos colaterais como dor, náuseas e vômitos, melhora a percepção do paciente quanto à qualidade de recuperação.(AU)

Objective: patient satisfaction is a complex and multifactorial concept that has gained much importance in the last decades, through the accreditation processes. In addition, patient satisfaction influences the relationship with the multidisciplinary team and, even, adherence to the proposed treatment. The patient's perception of the quality of postoperative recovery is one of the components that influence this satisfaction. The purpose of this review was to evaluate the factors related to the anesthetic and surgical procedure that interfere in the patient's perception of the quality of postoperative recovery. Method: during the period between March 1 and July 31, 2018, this integrative review researched the descriptors in the databases and found 52,000 citations of articles published between January 2011 and July 2018. Through the Boolean operators, the search terms were combined and the duplicate articles were deleted; 256 articles were evaluated and 51 were selected for this review. Conclusion: the use of drugs and techniques that minimize hospital stay or prevent side effects such as pain, nausea and vomiting, improves the patient's perception of the quality of recovery.(AU)

Objetivo: la satisfacción del paciente es un concepto complejo y multifactorial que ha adquirido mucha importancia en las últimas décadas, a través de los procesos de acreditación. Además, la satisfacción del paciente influye en la relación con el equipo multidisciplinario y, incluso, la adhesión al tratamiento propuesto. La percepción del paciente en cuanto a la calidad de recuperación postoperatoria es uno de los componentes que influencian esa satisfacción. El objetivo de esta revisión fue evaluar los factores relacionados al acto anestésico y quirúrgico que interfieren en la percepción del paciente en cuanto a la calidad de recuperación postoperatoria. Método: durante el período comprendido entre el 1 de marzo y el 31 de julio de 2018, la presente revisión integrativa investigó los descriptores en las bases de datos y encontró 52000 citas de artículos publicados entre enero de 2011 y julio de 2018. A través de los operadores booleanos, combinó los términos de la investigación y excluyó los artículos duplicados, evaluó 256 artículos y seleccionó 51 artículos para esa revisión. Conclusión: la utilización de medicamentos y técnicas que minimicen la permanencia hospitalaria o eviten efectos colaterales como dolor, náuseas y vómitos, mejora la percepción del paciente en cuanto a la calidad de recuperación.(AU)