The utilization and safety of apixaban for therapeutic anticoagulation in heart transplant population requiring routine endomyocardial biopsies.

PURPOSE: Routine endomyocardial (EM) biopsies pose a challenge in the management of heart transplant recipients requiring anticoagulation. Apixaban is a direct-acting oral anticoagulant (DOAC) with a short half-life allowing for brief interruptions of anticoagulation for procedures. The study objective was to determine the safety and efficacy of apixaban in heart transplant patients undergoing EM biopsies. METHODS: This retrospective case series evaluated patients with a heart transplant from April 1, 2017 to July 30, 2020 who were treated with apixaban within 90 days post-transplant. The primary outcome was the occurrence of a bleeding or thrombotic event. RESULTS: A total of 12 patients with >100 biopsies were included. The median age was 54 years (IQR 37-59) with a mean weight of 91 ± 20 kg. There were no bleeding or thrombotic events. During therapy, patients underwent an average of eight biopsies. The median time from transplant to initiation of apixaban was 39.5 days (range 9-77). Therapy was maintained without any need for reversal for a median of 276 days (IQR 45-245). CONCLUSIONS: Apixaban is safe to use for anticoagulation of heart transplant recipients undergoing routine biopsies. Using apixaban allows for a short interruption of therapeutic anticoagulation to accommodate a biopsy without increased risk of bleeding.

Intoxicated Donors and Heart Transplant Outcomes: Long-Term Safety.

BACKGROUND: The opioid crisis has led to an increase in available donor hearts, although questions remain about the long-term outcomes associated with the use of these organs. Prior studies have relied on historical information without examining the toxicology results at the time of organ offer. The objectives of this study were to examine the long-term survival of heart transplants in the recent era, stratified by results of toxicological testing at the time of organ offer as well as comparing the toxicology at the time of donation with variables based on reported history. METHODS: The United Network for Organ Sharing database was requested as well as the donor toxicology field. Between 2007 and 2017, 23 748 adult heart transplants were performed. United Network for Organ Sharing historical variables formed a United Network for Organ Sharing Toxicology Score and the measured toxicology results formed a Measured Toxicology Score. Survival was examined by the United Network for Organ Sharing Toxicology Score and Measured Toxicology Score, as well as Cox proportional hazards models incorporating a variety of risk factors. RESULTS: The number and percent of donors with drug use has significantly increased over the study period (P<0.0001). Cox proportional hazards modeling of survival including toxicological and historical data did not demonstrate differences in post-transplant mortality. Combinations of drugs identified by toxicology were not associated with differences in survival. Lower donor age and ischemic time were significantly positively associated with survival (P<0.0001). CONCLUSIONS: Among donors accepted for transplantation, neither history nor toxicological evidence of drug use was associated with significant differences in survival. Increasing use of such donors may help alleviate the chronic donor shortage.

Prospective validation of the SCAI shock classification: Single center analysis.

BACKGROUND: The Society for Cardiac Angiography and Interventions (SCAI) Shock Classification has been retrospectively validated by several groups. We sought to prospectively study outcomes of consecutive patients with reference to initial SCAI Shock Stage and therapeutic strategy as well as 24 hr SCAI Shock Stage reassessment. METHODS: Kaplan Meier method was used to describe survival and Cox Proportional hazards modeling used to assess predictors of survival. RESULTS: Over an 18-month period, 166 patients were referred for evaluation. Demographics, hemodynamics, and most laboratory findings were similar between SCAI stages, which were assigned by the team. Initial SCAI Stage was a strong predictor of survival. Thirty-day survival was 100, 65.4, 44.2, and 60% for patients with initial SCAI shock stage B, C, D, and E respectively (p = .0004). Age and initial SCAI Shock Stage were shown to be the strongest predictors of survival by Cox proportional hazards. Mode of mechanical circulatory support (MCS) or lack of such was not a predictor of outcome. Shock stage at 24 hr was also examined. Thirty-day survival was 100, 96.7, 66.9, 21.6, and 6.2% for patients with 3-4 SCAI stage improvement, 2 stage improvement, 1 stage improvement, no change in SCAI stage and worsening of SCAI stage respectively (p < .0001). CONCLUSIONS: Initial SCAI Shock stage predicts the survival of unselected patients with a variety of MCS interventions and medical therapy alone. The 24-hr reassessment of shock stage further refines the prognosis.

EMPROVING outcomes: Evaluating the effect of an ultralung protective strategy for patients with ARDS treated with ECMO.

OBJECTIVE: Since the initiation of an adult extracorporeal membrane oxygenation (ECMO) program at our institution, the program has managed well over 200 patients with ECMO in a 3-year time frame. While there is a plethora of research evaluating ECMO for acute respiratory distress syndrome (ARDS), few studies have evaluated the impact that ventilator management after cannulation might have on outcomes. We hypothesized that failure to properly protect the lungs after cannulation would lead to higher mortality. MATERIALS AND METHODS: This was a retrospective observational study performed from 1 January 2014 to 8 July 2018. RESULTS: A total of 196 patients were treated with ECMO, 57 of whom were diagnosed with ARDS and treated with venovenous ECMO. The univariable analysis revealed a statistically higher total serum bilirubin and lower total days on ECMO in those who died vs those who lived. During ECMO, higher mean peak inspiratory pressures (PIP) and higher FiO2 were found in those who died vs those who lived. In multivariable analysis, increasing age (odds ratio [OR] = 1.2; confidence interval [CI] = 1.04-1.39, P = .02), increasing mean PIP, and increasing mean FiO2 concentration during ECMO (PIP: OR = 1.40, CI = 1.03-1.89, P = .03; FiO2 : OR = 1.16, CI = 1.02-1.32, P = .02) were all associated with increased mortality. CONCLUSION: Failing to protect the lungs with a lung protective strategy such as the EMPROVE protocol after ECMO cannulation was associated with mortality. For every 1 mm Hg increase in the mean PIP, the odds of dying increased 1.4 times, and for every 1% increase in the mean FiO2 , the odds of dying increased 1.16 times. For lung rest to truly be effective, the lungs must be relieved of the burden of gas exchange.

Percutaneous Impella RP use for refractory right heart failure in adolescents and young adults-A multicenter U.S. experience.

OBJECTIVE: To assess the outcomes of the use of the percutaneous Impella RP device (Abiomed, Danvers, MA) in adolescents and young adults. BACKGROUND: Results of the Impella RP device have been reported in adults, but a multicenter experience in adolescents and young adults has yet to be reported. METHODS: Patients ≤21 years of age who underwent implantation of an Impella RP device for refractory right heart failure from June, 2016 to April, 2018 at nine U.S. Centers were included. RESULTS: A total of 12 adolescents, median age of 18 (14-21) years and median weight 74.4 (49-112.4) kg underwent Impella RP implantation (INTERMACS Profile 1 in nine and Profile 2 in three patients. The central venous pressure decreased from 20 (16-35) to 12 (7-17) mmHg, (p = .001). One patient was concomitantly supported with an intra-aortic balloon pump (IABP) and the rest with a percutaneous/surgically placed left ventricular assist device. There was one adverse event related to the Impella RP device (thrombosis requiring explant). The support duration was 6.5 days (4.8 hr-18.4 days) and survival to hospital discharge was 83%. At a median follow-up of 11 months (5 days-2.5 years), 8 of 12 (67%) patients are alive. CONCLUSIONS: In this multicenter experience, the Impella RP device was found to be efficacious and safe when used in adolescents and young adults. Further studies are warranted to identify suitable young/pediatric candidates for Impella RP therapy for right heart failure.

A 10-Year Trend Analysis of Heart Failure in the Less Developed Brazil.

BACKGROUND: Data on heart failure (HF) epidemiology in less developed areas of Brazil are scarce. OBJECTIVE: Our aim was to determine the HF morbidity and mortality in Paraiba and Brazil and its 10-year trends. METHODS: A retrospective search was conducted from 2008 to 2017 using the DATASUS database and included patients ≥ 15 years old with a primary diagnosis of HF. Data on in-hospital and population morbidity and mortality were collected and stratified by year, gender and age. Pearson correlation and linear-by-linear association test for trends were calculated, with a level of significance of 5%. RESULTS: From 2008 to 2017, HF admissions decreased 62% (p = 0.004) in Paraiba and 34% (p = 0.004) in Brazil. The in-hospital mortality rate increased in Paraiba and Brazil [65.1% (p = 0.006) and 30.1% (p = 0.003), respectively], but the absolute in-hospital mortality had a significant decrease only in Paraiba [37.5% (p = 0.013)], which was maintained after age stratification, except for groups 15-19, 60-69 and > 80 years. It was observed an increase in the hospital stay [44% (p = 0.004) in Paraiba and 12.3% (p = 0.004) in Brazil]. From 2008 to 2015, mortality rate for HF in the population decreased 10.7% (p = 0.047) in Paraiba and 7.7% (p = 0.017) in Brazil. CONCLUSIONS: Although HF mortality rate has been decreasing in Paraiba and Brazil, an increase in the in-hospital mortality rate and length of stay for HF has been observed. Hospital-based clinical studies should be performed to identify the causes for these trends of increase.

A 10-Year Trend Analysis of Heart Failure in the Less Developed Brazil / Insuficiência Cardíaca no Brasil Subdesenvolvido: Análise de Tendência de Dez Anos

Abstract Background: Data on heart failure (HF) epidemiology in less developed areas of Brazil are scarce. Objective: Our aim was to determine the HF morbidity and mortality in Paraiba and Brazil and its 10-year trends. Methods: A retrospective search was conducted from 2008 to 2017 using the DATASUS database and included patients ≥ 15 years old with a primary diagnosis of HF. Data on in-hospital and population morbidity and mortality were collected and stratified by year, gender and age. Pearson correlation and linear-by-linear association test for trends were calculated, with a level of significance of 5%. Results: From 2008 to 2017, HF admissions decreased 62% (p = 0.004) in Paraiba and 34% (p = 0.004) in Brazil. The in-hospital mortality rate increased in Paraiba and Brazil [65.1% (p = 0.006) and 30.1% (p = 0.003), respectively], but the absolute in-hospital mortality had a significant decrease only in Paraiba [37.5% (p = 0.013)], which was maintained after age stratification, except for groups 15-19, 60-69 and > 80 years. It was observed an increase in the hospital stay [44% (p = 0.004) in Paraiba and 12.3% (p = 0.004) in Brazil]. From 2008 to 2015, mortality rate for HF in the population decreased 10.7% (p = 0.047) in Paraiba and 7.7% (p = 0.017) in Brazil. Conclusions: Although HF mortality rate has been decreasing in Paraiba and Brazil, an increase in the in-hospital mortality rate and length of stay for HF has been observed. Hospital-based clinical studies should be performed to identify the causes for these trends of increase.

Resumo Fundamento: Dados sobre a epidemiologia da insuficiência cardíaca (IC) em áreas pouco desenvolvidas são escassos. Objetivos: Nosso objetivo foi determinar a morbidade e a mortalidade por IC na Paraíba e no Brasil, e sua tendência em dez anos. Métodos: Realizou-se uma busca retrospectiva de 2008 a 2017 utilizando-se o banco de dados do DATASUS incluindo pacientes com idade ≥ 15 anos, com diagnóstico primário de IC. Os dados da morbimortalidade por IC foram coletados e estratificados por ano, sexo e idade. Foram realizados correlação de Pearson e teste para tendências de Mantel-Haenzsel. Um nível de 5% foi definido como estatisticamente significativo. Resultados: De 2008 a 2017, as internações por IC diminuíram 62% (p = 0,004) na Paraíba, e 34% (p = 0,004) no Brasil. A taxa de mortalidade hospitalar aumentou na Paraíba e no Brasil [65,1% (p = 0,006) e 30,1% (p = 0,003), respectivamente], mas a mortalidade hospitalar em números absolutos apresentou uma diminuição significativa somente na Paraíba [37,5% (p = 0,013)], o que foi mantido após a estratificação por idade, exceto para os grupos 15-19, 60-69 e > 80 anos. Observou-se um aumento no período de internação [44% (p = 0,004) na Paraíba e 12,3% (p = 0,004) no Brasil]. De 2008 a 2015, a taxa de mortalidade por IC na população diminuiu 10,7% na Paraíba (p = 0,047) e 7,7% (p = 0,017) no Brasil. Conclusões: Apesar de a taxa de mortalidade por IC estar diminuindo na Paraíba e no Brasil, observou-se um aumento na taxa de mortalidade hospitalar e na duração da internação por IC. Devem ser realizados estudos clínicos em hospitais para serem identificadas as causas dessa tendência de aumento.

Heart failure enigma in young man: the acute onset of a frequently encountered condition with an unexpected cause.

An 18-year-old male patient presented to the emergency department complaining of new onset chest pain, fever and orthopnoea. Initial workup was remarkable for elevated troponin, diffuse ST-segment elevation on ECG and chest X-ray with enlarged cardiac silhouette. Transthoracic echocardiogram (TTE) demonstrates severe biventricular concentric hypertrophy and pericardial effusion. Also, Coxsackie virus A and B titres were positive, concerning for a classic viral pericarditis. However, despite medical management, the patient became dyspnoeic and hypotensive. Impending cardiac tamponade was observed on repeat TTE, and pericardiocentesis was performed, complicated by pulseless electrical activity cardiac arrest, and ultimately patient requiring venoarterial extracorporeal membrane oxygenation support. Emergent endomyocardial biopsy showed no inflammatory process, and a skin biopsy of a small lesion in the right arm showed unexpected diagnosis of Epstein-Barr virus (+) natural killer/T-cell lymphoma. On initiation of chemotherapy, clinical improvement was observed as evidenced by improving ejection fraction, resolution of pericardial effusion and gradual decrease in myocardial hypertrophy.

Is it safe to remove an infected cardiac implantable electronic device at the time of heart transplantation? Report of two cases.

Cardiac implantable electronic device (CIED) infections are treated with antibiotics and device explantation. Lack of CIED removal is associated with infection recurrence. However, CIED removal can be associated with major complications including death. We reported two patients with advanced heart disease who developed CIED infection due Staphylococcus epidermidis while awaiting for orthotopic heart transplantation (OHT). Both patients were managed with a different approach. They were treated with antibiotic therapy and had their CIED removal postponed until OHT. Both patients were kept on suppressive antibiotic treatment until undergoing simultaneous OHT and removal of infected CIED. None of the patients had infection recurrence. Large studies are needed to assess whether the approach of delaying CIED removal until OHT is safe among carefully selected patients with CIED infection.

In vivo resuscitation, perfusion, and transplantation of a porcine cardiac allograft donated after circulatory death.

OBJECTIVES: To test the feasibility of a novel method of heart donation under circulatory death criteria that allows precardiectomy donor heart assessment. MATERIALS AND METHODS: This is a translational study utilizing 16 female Yorkshire pigs in a series of eight heart transplant procedures under a circulatory death model. RESULTS: Successful resuscitation of the donor hearts occurred in seven out of eight animals. All seven of these hearts were deemed to have good function and were successfully transplanted. In the animal in which donor heart resuscitation was not successful, the transplant was aborted, and a left ventricular assist device (LVAD) was placed in the recipient's heart. CONCLUSION: This animal study demonstrates the feasibility of using this novel technique for resuscitation and precardiectomy evaluation of donated after circulatory death hearts. For those donor hearts without adequate function, an LVAD can be safely implanted as a "bail-out" option. The limitations of this technique are the patient population to which it can be applied (only those patients eligible and consented for LVAD).

Rescue therapy for hypercapnia due to high PEEP mechanical ventilation in patients with ARDS and renal failure.

Extracorporeal removal of carbon dioxide in patients experiencing severe hypercapnia due to lung protective mechanical ventilation was first described over four decades ago. There have been many devices developed and described in the interim, many of which require additional training, resources, and staff. This manuscript describes a readily available and relatively simple adjunct that can provide partial lung support in patients with acute respiratory distress syndrome complicated by severe hypercapnia and acute kidney injury requiring dialysis.

Impact of end stage renal disease on in-hospital outcomes of patients with systolic and diastolic heart failure (insights from the Nationwide Inpatient Sample 2010 to 2014).

BACKGROUND: Heart Failure (HF) and end stage renal disease (ESRD) are associated with increased morbidity, mortality, and are responsible for an immense economic burden. We sought to evaluate the impact of ESRD in heart failure by using a national cohort. METHODS: This is a retrospective cohort study using the National Inpatient Sample (NIS) of patients hospitalized with HF from 2010 to 2014. The primary outcome was in-hospital mortality. Multivariate regression was used for the statistical analysis. RESULTS: We identified a total 1,587,172 patients with systolic HF and 1,316,220 with diastolic HF. Patients with systolic HF and ESRD had higher in-hospital mortality (4.6% vs 2.7% OR: 1.86, p < 0.001). The in-hospital mortality in diastolic HF and ESRD was 2.7% vs 2.5% in those without ESRD (OR:1.11, p = 0.03). Patients with systolic HF and ESRD had significantly higher rates of ICU admissions (OR: 1.56, p < 0.001), mean length of stay (+1.5 days, p < 0.001), median hospital costs (p < 0.001), and acute respiratory failure (OR: 1.58, p < 0.001). Similarly, patients with diastolic HF and ESRD also had significantly higher rates of ICU admissions (OR: 1.59, p < 0.001), acute respiratory failure (OR: 1.54, p < 0.001), mean length of stay (+1.1 days, p < 0.001), and median hospital costs (p < 0.001). CONCLUSION: ESRD is associated with significantly increased in-hospital mortality in HF but the increase is nearly two-fold (86%) for systolic HF and very modest (11%) in diastolic HF. However, hospital costs, ICU admissions, acute respiratory failure, and length of stay are similarly higher for patients with both systolic and diastolic HF and ESRD.

A Weaning Protocol for Venovenous Extracorporeal Membrane Oxygenation With a Review of the Literature.

Several articles have discussed the weaning process for venoarterial extracorporeal membrane oxygenation; however, there is no published report to outline a standardized approach for weaning a patient from venovenous extracorporeal membrane oxygenation (ECMO). This complex process requires an organized approach and a thorough understanding of ventilator management and ECMO physiology. The purpose of this article is to describe the venovenous ECMO weaning protocol used at our institution as well as provide a review of the literature.

Outcomes of hemodynamic support with Impella in very high-risk patients undergoing balloon aortic valvuloplasty: Results from the Global cVAD Registry.

BACKGROUND: Reports on the role of hemodynamic support devices in patients with severe aortic stenosis (AS) and left ventricular (LV) dysfunction undergoing balloon aortic valvuloplasty (BAV) are limited. METHODS: Patients were identified from the cVAD registry, an ongoing multicenter voluntary registry at selected sites in North America that have used Impella in >10 patients. RESULTS: A total of 116 patients with AS who underwent BAV with Impella support were identified. Mean age was 80.41±9.03years and most patients were male. Mean STS score was 18.77%±18.32, LVEF was 27.14%±16.07, and 42% underwent concomitant PCI. In most cases Impella was placed electively prior to BAV, whereas 26.7% were placed as an emergency. The two groups had similar baseline characteristics except for higher prevalence of CAD and lower LVEF in the elective group, and higher STS score in the emergency group. Elective strategy was associated higher 1-year survival compared to emergency placement (56% vs. 29.2%, p=0.003). One-year survival was higher when BAV was used as a bridge to definitive therapy as opposed to palliative treatment (90% vs. 28%, p<0.001). On multivariate analysis, STS score and aim of BAV (bridge to definitive therapy vs. palliative indication) were independent predictors of mortality. CONCLUSION: In this large cohort of patients with AS and severe LV dysfunction undergoing BAV, our results demonstrates feasibility and promising long-term outcomes using elective Impella support with the intention to bridge to a definitive therapy.